Pfizer

Nervous system symptom reports

Female, 76 - 89 years

Age Reported Symptoms Notes
76 2021-01-04 numbness Numbness on right side of face
76 2021-01-06 feeling hot, flushing Patient immediately became flushed and hot. It lasted 5-10 minutes, returned to normal.
76 2021-01-09 feeling jittery, weakness Extreme tiredness, headache, weakness in legs making walking uncoordinated, to the point of losing m... Read more
Extreme tiredness, headache, weakness in legs making walking uncoordinated, to the point of losing my balance on Sunday, January 3rd, could not do my regular jog my legs were so uncoordinated on Monday, January 4th, and I fell over on my side when I squatted to pick up my cat at the end of the jog, Difficult to climb my front steps. Tuesday , January 5th, similar leg weakness and lack of coordination, but milder. Less weakness on Wednesday, Jan 6th, when just walking. Thursday, January 7th, did a jog, almost normal, but my left ankle not as responsive as usual. Headache the whole time, and feeling like too much caffeine. I only have one black tea in am. Symptoms seemed most severe in AM. Headache eased up in evening of 1/7.
76 2021-01-12 pain in extremity Pain in arm where vaccine was given
76 2021-01-21 weakness high fever 102, fatigue, no energy, aches in muscles in joints, nauseous
76 2021-01-21 weakness Four hrs. after getting the vaccine. My face started itching, could feel welts under the skin. Swe... Read more
Four hrs. after getting the vaccine. My face started itching, could feel welts under the skin. Swelling of the right side of my face started within a few hours later. Called Drs. , He recommended taking Tylenol. (Second Day) Next day, felt short of breath, weak, applied ice packs to my face. Third day, felt weak. By the fourth day, swelling and itching subsided; but skin on my face felt gritty under the skin. Drove me to the doctor's office the third day. I was short of breath walking from the car to the door to the doctor's office. I was wearing my mask. I saw a PA; but, she didn't tell me much of anything. I don't think she knew what to say.
76 2021-01-22 muscle spasms, tremor Severe chills/tremors.....my entire body was shaking/spasming. It shook my bed and woke me up. Sever... Read more
Severe chills/tremors.....my entire body was shaking/spasming. It shook my bed and woke me up. Severe sore arm at injection site.
76 2021-01-23 pain in extremity injection site pain/arm hurts tiredness headache slight muscle pain/joint pain ***nausea feeling lou... Read more
injection site pain/arm hurts tiredness headache slight muscle pain/joint pain ***nausea feeling lousy arm feels like its blown up but doesn't look like it is
76 2021-01-24 feeling cold Dep Cough, Chills
76 2021-01-25 numbness Numbness in arm at 11:02 am V/S 109/61 p. 64 at 11:10 am V/S 128/66 p. 68
76 2021-01-26 feeling hot Jan 26, 2021: 3:00 pm, mild fatigue 9:00 pm sound asleep (unusually early for me) Jan 27, 2021 1:30... Read more
Jan 26, 2021: 3:00 pm, mild fatigue 9:00 pm sound asleep (unusually early for me) Jan 27, 2021 1:30 am woke up feeling hot and perspiring (really unusual for me, but I did not think much about it at the time) 3:00 pm - mild headache ( unusual for me, but I did not take anything for it) 5:00 pm felt mildly unwell and felt mildly chilled 5:30 pm, took temperature - 99.5 - and did not want anything to eat - no nausea, just not hungry. 8:30 pm, took temperature - 100.2, ate some mild cheese and fruit (pear) and coca-cola to settle my stomach a little
76 2021-01-27 pain in extremity sore arm
76 2021-01-28 pain in extremity, weakness Took shot 1/20 and asked the RN if I should take it because I explained I just got over covid, I tol... Read more
Took shot 1/20 and asked the RN if I should take it because I explained I just got over covid, I told her I wasn?t sure how long it was on Dec 19 I was raking leaves and I thought I should do this because I started having runny nose. I didn?t feel well that afternoon sneezing because I thought it was nothing. As the week went on I started sneezing and coughing and stopped up nose. I always end up with sinus infection when I get a cold Dec 28 I went to the doctor at doctors care and they did a covid test before the doctor would see I tested positive. I went home and rested, no energy, felt like I was hit by a train, couldn?t breathe, sneezed a lot and hardly coughed. January 1, I called ambulance and went to hospital, I was sick the first week of January. I didn?t know that you should wait 90 days to get the vaccine after you?ve had Covid. After I got the vaccination the adverse reaction, I woke up during the night with my arm hurting bad and throbbing and a very large red circle appeared on my arm 2? in diameter. The next 3 days I felt like I had covid all over again, the 4th day I woke up and felt a little better and got out of bed and started making progress each day. Now I?m not good, but I?m ok.
76 2021-01-28 pain in extremity Sore arm; mild nausea; mild headache; low grade fever; an odd red mark on my left shoulder about 2 o... Read more
Sore arm; mild nausea; mild headache; low grade fever; an odd red mark on my left shoulder about 2 or 3 inches from the injection site; This is a spontaneous report from a contactable consumer (reporting for herself). A non-pregnant 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm on to 14Jan2021 07:15 at a single dose for COVID-19 immunization. Medical history included asthma, chronic obstructive pulmonary disease (COPD), known allergies: animals. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), lorazepam (ATIVAN), biotin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN). The patient previously received a typhoid shot (MANUFACTURER UNKNOWN), for immunization and had very adverse reaction to third typhoid shot. The patient experienced sore arm, mild nausea, mild headache and low-grade fever and an odd red mark on left shoulder about 2 or 3 inches from the injection site on 14Jan2021 21:00. No treatment was received for the events. The outcome of the events was recovering.
76 2021-01-28 tremor, weakness Within 5 minutes I became nauseated, then l began growing weak, alerted staff and they started monit... Read more
Within 5 minutes I became nauseated, then l began growing weak, alerted staff and they started monitoring my blood pressure which had gone up to 159 (usual is around 120), began uncontrollable shaking. After about 1 1/2 hours my blood pressure lowered to 136 and I was transported by wheel chair to car to return home.
76 2021-01-29 feeling hot 16 hrs after the injection.. i had a shaking chill lasting about 30 min relieved somewhat by tyleno... Read more
16 hrs after the injection.. i had a shaking chill lasting about 30 min relieved somewhat by tylenol and motrin, followed by feeling hot and sweaty, the next day I was wiped out and rested ... the shortness of breath began somewhat later on weds pm and worsened on Thursday ... I had several breathing treatments thurs and friday which seemed to help somewhat.. On Saturday I am feeling better overall with less dyspnea . still feeling wiped out after several hrs of mild activity.
76 2021-01-30 feeling cold, muscle twitching, tremor 36 hours after vaccine, on 01-30-21 went to bed at 9;00 PM. Could not sleep. Mind darting about an... Read more
36 hours after vaccine, on 01-30-21 went to bed at 9;00 PM. Could not sleep. Mind darting about and remembering past experiences. At 11;00 PM I started feeling cold with muscles twitching in legs. Got out of bed with difficulty walking and shaking and teeth chattering. Shaking became more intense. Put on more clothes and sat by fireplace. Took 2 Tyneol and ate banana. Continued to shake all over for 10 mins. Shaking so much could not hold phone. Subsided. Startrd again lasting for 10 mins. Subsided and finished at 11:30 PM. Stayed up until 1;00 PM. To bed and had difficulty sleeping. Feel alright today.
76 2021-01-31 weakness red swollen arm at injection site; red swollen arm at injection site; red swollen arm at injection s... Read more
red swollen arm at injection site; red swollen arm at injection site; red swollen arm at injection site, became itchy lasted 1 week.; elevated temperature; body weakness; severe headache for 3 days; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3246), via an unspecified route of administration at site of left arm at 11:00 on 09Jan2021 at single dose for covid-19 immunization. Medical history included lung cancer, chronic obstructive pulmonary disease (COPD), atrial Fib, hypertension and COVID. The patient's concomitant medications were not reported. The patient experienced red swollen arm at injection site, became itchy lasted 1 week. elevated temperature, body weakness, severe headache for 3 days, all occurred at 05:00 on 10Jan2021. Facility type vaccine was Doctor's office/urgent care. No other vaccine received in four weeks. Other medications received in two weeks. Adverse reactions did not result any serious consequences. No treatment received for adverse event. No COVID tested post vaccination. No known allergies. The outcome of events was recovered in Jan2021.
76 2021-01-31 feeling hot, cold sweat Patient was observed for 15 minutes after the vaccination administration, felt fine, and left the fa... Read more
Patient was observed for 15 minutes after the vaccination administration, felt fine, and left the facility with her husband. The 2 of them drove 2 blocks away to a restaurant to eat. Midway through her meal, she reported that she started to feel "funny" like she was "drunk" or something, and felt nausea and hot/sweaty. Her husband got her in the vehicle and drove to the vaccination facility, When he arrived, she was obtunded and "out of it." No respiratory distress, No noted rash, but some clamminess/diaphoresis. She was initially examined by FNP and cursory limited neuro exam while patient was seated did not reveal any gross motor deficits. FNP called 911 and staff called for me. When I arrived, patient was groggy, but responsive. She was A&O x3 and in no distress. Pulse 54, strong and regular (normal rate for her per patient--on a Beta blocker). BP 120/74. O2 sat 97% on outdoor cold air. Patient was able to move all extremities equally and with equal strength. Lungs CTA, Heart regular no murmur, abdomen soft. Patient complained of continued malaise/grogginess and nausea, no vomiting. EMS arrived, checked glucose, which was "normal" (I didn't hear the result) and patient declined transport. I discussed ER evaluation vs. continued monitoring by me. Patient and husband requested monitoring. Patient stayed in the vehicle with her husband, I gave the husband my phone number to call if any worsening. I checked on her 5 minutes later, then 10 minutes after that. By that time, her adult daughter had arrived. We again discussed continue family monitoring vs. ER. The family wanted to take the patient home to monitor. Patient stated "If I could just go to bed, I think I will be fine." I called to check on the patient at 6p. She had rested well and was improved. She still felt a bit groggy, but otherwise was feeling better. I called to check on the patient 1/29 at noon. At that point, husband stated that she was "back to normal. Symptoms and signs appeared to be consistent with a vasovagal response. I suspected symptoms may have been prolonged by her Beta blocker
76 2021-01-31 feeling hot Patient experienced chest heaviness and warmth from her chest to her arm. Her blood pressure was 220... Read more
Patient experienced chest heaviness and warmth from her chest to her arm. Her blood pressure was 220/120s. We monitored her and her blood pressure decreased to 170s/110s over 30 minutes. EMS was called to evaluate her but she refused to go to the hospital.
76 2021-01-31 tremor Shortness of breath, slight chest pain, shakiness, hypertension above normal BP
76 2021-02-01 weakness 76 yo female with PMHx of CAD s/p CABG 2016, abdominal aortic aneurym, HTN, HLD, Asthma, Diverticulo... Read more
76 yo female with PMHx of CAD s/p CABG 2016, abdominal aortic aneurym, HTN, HLD, Asthma, Diverticulosis, Osteopenia. Presenting to the ED after having Pre-syncope. She reported that today morning she felt nauseated with episode of vomiting, burping and abdominal discomfort after having her lunch meal, headed out to receive her vaccine, she felt well till 10 minutes after the vaccine where a nurse noticed she is pale and less responsive, BP was measured back then and was ~70 ?, the patient reported that she was sitting when that happened, she felt lightheaded, sweating, blurry vision, nauseated. But denies any chest pain, sob, palpitation, weakness or numbness. She was out of balance and feeling weak till she came to the ED where she felt better after IV fluids.
76 2021-02-02 tingling, pain in extremity, burning sensation, tremor Anaphylaxis symptoms started three day after the shot I started having chills, trembles, sore throat... Read more
Anaphylaxis symptoms started three day after the shot I started having chills, trembles, sore throat, very high BP, Swelling and numbness on tongue and lips, pain and burning of feet, tingling all over, joint pain,
76 2021-02-03 migraine, weakness, tremor I received this shot on Jan 30 and have been sick ever since. I Threw up for several days and and st... Read more
I received this shot on Jan 30 and have been sick ever since. I Threw up for several days and and still sick to the stomach. I had severe diarrhea and my bowels are still messed up- they are light yellow verging on white. I have been having migraines and am very weak and shaky. Pain at injection site is trivial. Pain through out my body is not. I am often dizzy.
76 2021-02-03 pain in extremity sore arm, no treatment necessary
76 2021-02-04 numbness and pain in extremities Site uncomfortable for week plus one day. Then hard pain in shoulder and spreading across shoulder,... Read more
Site uncomfortable for week plus one day. Then hard pain in shoulder and spreading across shoulder, up neck and down around collar bone. Went to Dr. and was told it was neuropathy and was prescibed Prednisone.
76 2021-02-04 tremor, tingling, cold sweat Rapid heartbeat, shaky, clammy skin, heavy perspiration, nausea, stomach cramps, pain throughout bod... Read more
Rapid heartbeat, shaky, clammy skin, heavy perspiration, nausea, stomach cramps, pain throughout body along with pin and needle feeling mostly on the left side from my foot to the top on my head. Lips felt swollen. Itch in chest, neck with a rash, back legs, mostly all over.
76 2021-02-05 tingling Sensation seeming to involve nerves or nervous system, radiating through back, shoulders, arms and h... Read more
Sensation seeming to involve nerves or nervous system, radiating through back, shoulders, arms and hands. Started 24 hrs after first shot and decreased intensity and duration over next 3 wks till almost completely gone. Sensation began again less than 24 hrs. after second shot on 02/04/21 but much less severe than with first vaccination. Tingling is as close as I can describe the sensation but not altogether accurate.
76 2021-02-06 numbness C/O BILATERAL FACIAL NUMBNESS. NO SOB, TONGUE, LIP OR FACE SWELLING. 0940 BENEDRYL 25MG GIVEN ORA... Read more
C/O BILATERAL FACIAL NUMBNESS. NO SOB, TONGUE, LIP OR FACE SWELLING. 0940 BENEDRYL 25MG GIVEN ORALLY. PATIENT OBSERVED FOR APPROXIMATELY 45 MIN. NO PROGRESSION OF SYMPTOMS. PATIENT HOME WITH GRANDSON. INSTRUCTED TO CALL 911 FOR SOB OR FACIAL SWELLING. TO CALL MD IF FACIAL NUMBESS CONTINUES.
76 2021-02-07 unresponsive to stimuli Pt received injection, then collapsed, with no memory of event. Pt was unresponsive approximately 1... Read more
Pt received injection, then collapsed, with no memory of event. Pt was unresponsive approximately 15 seconds. HR 52 & irregular, BP 110/80
76 2021-02-08 weakness, pain in extremity Chills, fever, muscle aches, weakness, fatigue, nausea lasted 24 hours, then fatigued for another 12... Read more
Chills, fever, muscle aches, weakness, fatigue, nausea lasted 24 hours, then fatigued for another 12 hours. Recovered completely within 36 hours. Arm red, sore and swollen for 36 hours
76 2021-02-08 tremor I had tremors for 48 hours after the shot, starting about 2 hours after shot also had a choking feel... Read more
I had tremors for 48 hours after the shot, starting about 2 hours after shot also had a choking feeling. I took Benadryl before and after.
76 2021-02-09 feeling hot Two days after receiving the vaccine, I began to have the feeling that my insides (as in my "guts" o... Read more
Two days after receiving the vaccine, I began to have the feeling that my insides (as in my "guts" or my intestines) were on fire. I didn't have diarrhea, but the feeling was very intense and I had to go to bed. I took Pepto Bismal, hoping it would alleviate the awful feeling. It wasn't like any other stomach or intestinal upset I've ever had. It literally felt as though my insides were "on fire", inflamed. The feeling persisted for 2 days and then went away. During that time, I just ate tea and toast and hoped that I wouldn't see any blood in my stool. It was very frightening.
76 2021-02-09 numbness, pain in extremity When the nurse gave me the first dose, she said "your arm is so small I thought I might of hit your ... Read more
When the nurse gave me the first dose, she said "your arm is so small I thought I might of hit your bone". When I got home and took the Band-Aid off there was a small red mark, which went away by the next morning. Then next day after that I started having extreme pain and numbness in my left arm. The pain is from my shoulder, to my fingertips, and under my arm. It is still hurting today. I have been taking Advil, putting pain cream on it. It is still hurting as of now.
76 2021-02-09 pain in extremity Her arm is sore; This is a spontaneous report from a contactable consumer(patient) from a Pfizer spo... Read more
Her arm is sore; This is a spontaneous report from a contactable consumer(patient) from a Pfizer sponsored program. A 76-year-old female patient received the first dose of BNT162B2 (lot number: EL8982), via an unspecified route of administration on an unknown date at single dose for COVID-19 immunization. The patient's medical history included asthma and allergy. Concomitant medications included unspecified medication for asthma and allergies. The patient received the first dose of the COVID-19 vaccine and her arm was sore after receiving it, she wanted to know if she can take Tylenol or use an ice pack. The outcome of the event was unknown.
76 2021-02-10 feeling hot, burning sensation BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back... Read more
BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back; Back getting hot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 76-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date not reported) , via an unspecified route of administration on the left arm on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included anaphylaxis with contrast media (Biaxin and eucalyptus), allergies: latex, antihistamines, sulfa, olive trees; allergic reactions to iodine, asthma, cardiac arrest, has a pacemaker; all from unknown dates. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), vitamin D3, levocabastine hydrochloride (ZYRTEC), iron, diltiazem, salbutamol sulfate (ALBUTEROL). The patient previously took Biaxin, eucalyptus and tiger balm and experienced anaphylaxis, Cipro, sucralfate, adrenaline (EPIPEN), corticosteroid and experienced allergies. The patient previously received Shingles vaccine on Nov2020 for immunization and experienced intermittent itchy back sensation. The patient reported that after vaccine reaction today (27Jan2021) - back rash, burning sensation, swollen face. It was further reported that the patient experienced potential anaphylactic reaction; 15 minutes after the administration she got her back getting hot and Itchy and a rash breakout. It was also reported that the patient's BP was a bit high for her on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: a bit high for her on an unspecified date. Therapeutic measures were taken as a result of anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot which included treatment with Benadryl (Took one 25 mg Benadryl. Then she took another 25 mg Benadryl); it was reported that 30 minutes later symptoms started to subside. The patient recovered from anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot on 27Jan2021, while the outcome of BP was a bit high for her was unknown.
76 2021-02-10 hot flush Client received Pfizer covid vaccine, and during her observed wait time, she became hot and felt a f... Read more
Client received Pfizer covid vaccine, and during her observed wait time, she became hot and felt a flush through her body. She also reported tingling in her tongue and throat. She reported itching of her chest, cheeks, and ears. Client was brought back to emergency area, and was assess by nurses. Client did have a prior history of allergy to Iodine and shellfish- but never anaphylaxis. 10:20am, pulse 68, bp 142/83, 98% O2. 10:25am, bp 140/85, still complaining of throat swelling and itching, pulse ox stil 98%. Once client was in a private area, she reported that the flushing and feeling of being hot, had gotten much better. Per Client , her tongue and throat, were not getting worse. Our Medical Director was contacted, and the decision was made to give Benadryl IM. 10:39 pulse 70, O2 95%, . 10:41 am 1ml (50 mg) Benadryl given IM in the right deltoid (lot # 080014, exp. 8/2022). Within a few minutes patient reported that signs and symptoms were better but had not completely gone away. 10:44, respirations 14/minute, O2 94%, patient sat up at this time to help clear some phlem. 10:46 client states tongue feels better. 10:53 am 96% O2, pulse 93. Nurses continued to monitor client, and asked if she felt any worsening of her symptoms to warrant more medication. Client stated she felt a little better and would like to go home. 11:15 am, spoke to Docter again, per his instruction, client was allowed to go home with her sister. Instructed to take more Benadryl in 4 hours if symptoms return. Client was told if anything gets worse than her original symptoms, regarding her airway, tongue, lips, swallowing, she should call 911.
76 2021-02-12 weakness Slight headache began about 6 hrs after shot. Extreme tiredness and light headedness hit the mornin... Read more
Slight headache began about 6 hrs after shot. Extreme tiredness and light headedness hit the morning of the next day. Complete loss of energy...and I am a VERY energetic person. Tiredness and light headedness has continued from 2/4 thru 2/13 with no let up. 11 hrs of sleeping at night after being on couch all day. NO loss of appetite, taste, smell, fever, or aches. Headache lasted only a few days.
76 2021-02-13 feeling of body temperature change, pain in extremity, weakness extreme Chills followed by being very Hot and then chills again , headache , teeth hurt , eyes sensi... Read more
extreme Chills followed by being very Hot and then chills again , headache , teeth hurt , eyes sensitive to light and eye balls aching and still are ,temperature 3rd day morning 100.2 never checked on 2nd day. Shot in the arm hurt 1 st day where a 1st doze shot did not hurt till next day, nausea, weakness all over and joints hurt. I took1/2 of 2 percocets 1half every 3 hours for 12 hours and that helped with headache and teeth..tylenol did not help headache and I never have headaches. I thought I was dying. I spoke to friends who have had 2nd dose and most experienced some but not all and many nothing after 2nd dose.
76 2021-02-14 weakness Woke from sound sleep at 4 am (approximately 14 hours after having the vaccine shot) -- chilled, an... Read more
Woke from sound sleep at 4 am (approximately 14 hours after having the vaccine shot) -- chilled, and every part of body hurt. Went back to bed. 6 am still hurt everywhere, short of breath (oxygen concentration at 90 and sometimes below--thankfully I had oxygen as I sleep with it). Running a temperature of 100., disoriented, heart rate at 115+ and I hurt everywhere. 8 am called Dr. & left call-back. 1 pm tried Dr. again. Told person on telephone and he told Nurse Practitioner. They ordered nose spray because I mentioned I may have a sinus infection as my head hurt, my ears hurt. I continued Tylenol every 6 hours on Friday and Saturday (all day). I was able to get up and do a few things on Saturday. Felt better on Sunday but still weak feeling. Oxygen saturation back to 95-96 and heart rate under 100.
76 2021-02-14 night sweats Got awake morning following vaccination feeling much like I did when I first became ill with COVID. ... Read more
Got awake morning following vaccination feeling much like I did when I first became ill with COVID. Spent whole day in bed. No appetite. Felt a little better next day but knew I was about to pass out so laid down in hallway where my husband found me. Got better as day went on and feel fairly well today. Also had a mild case of night sweats last night. They were awful when I actually had COVID - for about 2 weeks.
76 2021-02-14 cold extremities, pain in extremity I couldn't get out of bed for two days at least and I had high temperature between 103-104 and I had... Read more
I couldn't get out of bed for two days at least and I had high temperature between 103-104 and I had terrible chills, My hands were so cold that they were hurting me. I took some advil and that helped. By Sunday I was starting to feel to better, Monday I was still tired and a low grade fever.
76 2021-02-15 pain in extremity One week after the first vaccine, I had severe pain in my right arm. I could barely lift it. applie... Read more
One week after the first vaccine, I had severe pain in my right arm. I could barely lift it. applied ice and pain lessened...Then other events followed...My left wrist became swollen and red. then a day later the severe pain was in my left arm and I could barely lift it. I then had a swollen right foot. Podiatrist gave me a shot of cortisone but continued to have the pain and swelling...Shoulder pain returned. 2nd vaccine was 02/03/2021...Feb 10...both hands were stiff and I couldn?t open them...Then the shoulder pain in my right arm returned . This lasted 4 days...with the most severe pain.
76 2021-02-16 tingling, numbness Injection was painful - arm numb and tingled to fingers. 10:45b/p 116/62 pulse68 respirations 1... Read more
Injection was painful - arm numb and tingled to fingers. 10:45b/p 116/62 pulse68 respirations 16 Normal movement,color and temperature in fingers. Capillary refill <3 seconds. Client refused further medical treatment.
76 2021-02-17 pain in extremity A feeling of extreme tiredness , & semi nauseous . High temperature 100.2 . ache all over . My arm a... Read more
A feeling of extreme tiredness , & semi nauseous . High temperature 100.2 . ache all over . My arm ached but not too much but my body ached all over like you get with the flu which I've never had. I was like that for 2 days. I didn't want to eat or do anything. Then I tried to keep eating a little & drinking anything water, coffee,& tea hot & iced . On the 3rd day I felt better not well but better.
76 2021-02-18 weakness Complained of dizziness, watery eyes, runny nose, and weakness shortly after receiving her second do... Read more
Complained of dizziness, watery eyes, runny nose, and weakness shortly after receiving her second dose of Pfizer. She \ requested to lie down and was escorted to a stretcher. She was provided oral loratidine with slight improvement of symptoms. Approximately 30 minutes after her inoculation her status had not worsened but she requested to be taken to the emergency department. Rapid Response team was notified and assisted her to the ED.
76 2021-02-18 weakness After receiving the vaccine, my daughter took me to my Cardiologist appointment (this was scheduled ... Read more
After receiving the vaccine, my daughter took me to my Cardiologist appointment (this was scheduled before I received the vaccine). When I got to my doctor my blood pressure was elevated, it was about 180/88. My blood pressure is never that high. It did go down before I left to 140/84. When we were walking in the elevator after leaving the appointment my gait was unsteady. I felt very weak. I also light headed, and dizzy. It felt like the feeling of the sedation you have receive before having surgery. When we made it home I couldn't even see straight. This lasted about 2 hours. I feel much better today.
76 2021-02-18 pain in extremity, muscle spasms My reactions started on Feb 10, Wed nite, with pain going from the left shoulder to right shoulder. ... Read more
My reactions started on Feb 10, Wed nite, with pain going from the left shoulder to right shoulder. Next day pain was in the right lung, severe, (could not take a breath). Next day the pain and discomfort traveled dow my right leg, extreme cramps, soreness, etc. The next day it was my left lung in severe pain. By Monday my breathing is very shallow and my cough is much worse, each cough produces its own package of phlem. Breathing is diffiicult I HAVE AN APPOINTMENT TO RECEIVE SECOND SHOT ON FEB. 24. I DO NOT THINK I SHOULD
76 2021-02-18 pain in extremity swollen face, sinus pain, sore arm
76 2021-02-21 inability to speak CLIENT STATES 9:15AM ON 2-5-21 SHE WAS PASSENGER IN CAR AND HUSBAND NOTICED THAT SHE HAD STOPPED TAL... Read more
CLIENT STATES 9:15AM ON 2-5-21 SHE WAS PASSENGER IN CAR AND HUSBAND NOTICED THAT SHE HAD STOPPED TALKING AND WAS JUST STARRING X 2 MIN, THEN BECAME RESPONSIVE AND TALKATIVE AGAIN. SHE WAS 'NOT QUITE HERSELF FOR ABOUT 3 DAYS'. MRI, MRA, CT OF BRAIN & U.S. OF CAROTIDS DONE. DX WITH RT TEMPORAL/PARIETAL CVA. NOW ON PLAVIX & ASA 81MG. HAS APPT WITH NEUROLOGIST 2-17-21. REMAINS 'NOT QUITE HERSELF AND OFF BALANCE'.
76 2021-02-21 flushing, hot flush flushed, feels hot 169/89 80 98.8 F temp 96% SAT #21 Home follow up with pcp
76 2021-02-22 weakness, restless legs syndrome Pfizer-BioNTech COVID-19 first dose, 1/23/2021, little reaction. second dose, 2/13/2021: headache on... Read more
Pfizer-BioNTech COVID-19 first dose, 1/23/2021, little reaction. second dose, 2/13/2021: headache one day later, disorientation/foggy mind 2 days after, then cleared up, muscle pain was short-lived, moderate chills, feeling unwell with weakness, restless leg syndrome (managed since 2004 with medications) returned 10 days after second shot.
76 2021-02-22 pain in extremity, tingling post injection, c/o pain and tingling bilateral arms, chest tightness, and tongue "feels strange", d... Read more
post injection, c/o pain and tingling bilateral arms, chest tightness, and tongue "feels strange", difficulty breathing
76 2021-02-23 impaired body coordination Within 1-2 days of second COVID vaccine, patient developed ataxic gait. After ~7-10days of symptoms,... Read more
Within 1-2 days of second COVID vaccine, patient developed ataxic gait. After ~7-10days of symptoms, she saw her primary care, who referred the patient to the ER for stroke work-up. MRI of the brain with and without gadolinium contrast showed sub-CM lesions. Pan-CT scan showed no evidence of malignancy. LP for CSF analysis shows lymphocytic pleocytosis. Complete axonal MRI of the spine (cervical, thoracic and lumbar) shows T2 cord signal abnormalities concerning for demyelinating process. Overall, highly concerning for COVID mRNA vaccine induced acute disseminated encephalomyelitis (ADEM). Treatment initiated with glucocorticoids.
76 2021-02-23 numbness, pain in extremity 3-4 days after the vaccine, the patient developed severe stabbing pain in the hands and feet followe... Read more
3-4 days after the vaccine, the patient developed severe stabbing pain in the hands and feet followed by worsening numbness in the hands and feet with weakness of the hands and trouble with her balance
76 2021-02-23 migraine Patient experienced pain headache or migraine after vaccination . Onsite EMS was called vitals BP 15... Read more
Patient experienced pain headache or migraine after vaccination . Onsite EMS was called vitals BP 158/94 99% O2 room air HR 64. Patient Refused Evaluation/Care released against medical adive.
76 2021-02-23 pain in extremity Sore arm only
76 2021-02-25 slurring, inability to speak speech/word finding difficulty ( dysarthria ), Novocain like feeling left perioral area( perioral a... Read more
speech/word finding difficulty ( dysarthria ), Novocain like feeling left perioral area( perioral anesthesia ) , drooling of food occasionally
76 2021-02-25 involuntary muscle movements, weakness Received shot at approximately noon and within a few hours, began not feeling well and by that night... Read more
Received shot at approximately noon and within a few hours, began not feeling well and by that night developed fever 102 with loss of appetite, chills, weakness, unable to stand - her legs developed spasms and jerking. The next day, temp continued to climb up to 102.6 with continued issues with spasms and jerking to lower extremities. Did not seek medical care but did take natural herbs and nutritional supplements to treat. Symptoms have lessened each day but were persistent for 10 days post vaccination. Has a hx of CLL diagnosed in 2008 and WBC runs persistently high.
76 2021-02-25 difficulty speaking Patient was here for her 2nd dose vaccine and during her wait time her tongue started to feel funny ... Read more
Patient was here for her 2nd dose vaccine and during her wait time her tongue started to feel funny and swell slightly. Staff was notified as they were talking with her that her voice sounded a little funny and thick. She also started to cough on a regular interval. As staff continued talking with her she stated her throat started to feel funny and tight. Staff notified other healthcare personal and moved her to the private treatment area. She continued to complain of thick tongue and continued to speak different then her baseline. We elected to give 50 mg Benadryl IM. She was also placed on the ECG showing sinus rhythm with O2 stats of 100 % and her blood pressure was 149/61, After the Benadryl, she stated she started to fell somewhat better. After about 10 minutes her tongue started to swell again and when she turned her head to speak to a staff member her airway shut off due to swelling. Staff quickly turned her head back to forward she was able to breath again. She advised that she needed to be transported and was going to get 0.3 epi IM in her left arm. She did state prior to Epi being given she was now also having trouble focusing visually. Dr arrive to assess her and agreed that she needed transported. EMS arrived and care was turned over to Huntertown EMS to transport the patient to Medical Center.
76 2021-02-25 facial pain Left side of face pain including eye inside mouth and throat. Felt like bad sinus infection. Still h... Read more
Left side of face pain including eye inside mouth and throat. Felt like bad sinus infection. Still have some throat pain
76 2021-02-25 mild one side paralysis Patient looses control of it's left side, falls on it's left side and hits their head. Take to the H... Read more
Patient looses control of it's left side, falls on it's left side and hits their head. Take to the Hospital and is now connected to a mechanical ventilator.
76 2021-02-25 migraine migraines; anxious; headache; This is a spontaneous report from a contactable consumer, the patient.... Read more
migraines; anxious; headache; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), intramuscularly, on 23Jan2021 at 11:30 (at the age of 76-years-old) as a single dose in the left arm for COVID 19 vaccination. Medical history included stress related to work and a preservatives allergy which give her headaches. Historical vaccinations included pneumonia vaccine (UNKNOWN MANUFACTURER but reported as "Pneumonia 13") on an unspecified date "four years ago" after which she developed a headache which she attributes to an allergy to unknown preservatives. She never received the second "Pneumonia 13" because of the reaction with the first one. She also reported that she has had this same reaction of headache attributed to allergy to unknown preservatives when eating fast foods and foods with sauces. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was administered at a County Convention Center. On 23Jan2021 at 11:45, fifteen minutes after she received the vaccination, the patient developed a headache which she has had ever since she got in on Saturday. She also stated that it feels like "a migraine on steroids." She did tell the person at the clinic where she received it. She stated that she is "hypoallergenic" and she had to sit for thirty minutes after receiving it. She was already anxious and about fifteen minutes in, she developed the headache and nothing has helped so far. She added that she has not had a headache in a long time and that is why she feels it is the shot. She reported that what she took for treatment did not work. These treatments included: Acetaminophen Extra Strength 500mg NDC 21130-111-90. Lot 9ME2806A, expiration 20Jul2021. Count size is 500 caplets, Motrin Ibuprofen tablets 200mg. Lot 6ME1058A, Expiration Sep2018. Count size 100 caplets which when taken was an expired product, SalonPas Roll On Lot 192498, Expiration Jan2022. Count size is 1 container with 3 fluid ounces or 88ml and Neck Wrap and Wrist Heat Wraps which is reported as "a generic equivalent of Thermacare" with Lot number 91211OC16, Expiration 10Dec2022. She did not take the heavy duty Motrin because it was out of date. She commented that all of these things had helped in the past. The clinical outcomes of the event headache, migraine and anxiety were reported as unknown.
76 2021-02-25 pain in extremity Three days after the Covid-19 vaccine injection, left arm became reddened, warm to the touch, painfu... Read more
Three days after the Covid-19 vaccine injection, left arm became reddened, warm to the touch, painfully tender, lumpy under the skin, over an irregular area approximately 4x5 inches. Doctor diagnosed infection as cellulitis, and prescribed doxycycline 100mg for 5 days. Because of the underlying primary immune deficiency, this will be a difficult adverse event to overcome. First noticed on February 25, 2021. Covid-19 vaccine was administered on Monday February 22nd 2021.
76 2021-02-26 tremor, inability to speak, weakness Within an hour, I felt like I had been hit by a tank; difficulty breathing, dysequilibrium, problems... Read more
Within an hour, I felt like I had been hit by a tank; difficulty breathing, dysequilibrium, problems with balance that induced dizziness and vertigo, wobbly gait, extreme weakness, continual tiredness--not refreshed by sleep, difficulty sleeping, insomnia, injection site pain, severe headaches for weeks, eyeball pain, chills, fever, inflammation, joint pain, muscle pain, activity-induced or cognitive exertion muscle fatigue, nausea, swollen lymph nodes, especially in neck, sore throat, difficulty swallowing, cognitive problems -- difficulty with memory, focus, concentration, problems with wordfinding ability, misspeaking; short-term blurry vision; extreme difficulty with body temperature control leading to shaking
76 2021-02-27 weakness, facial paralysis Received the vaccine & the next day became very weak and ill with throwing up. Her sister came to vi... Read more
Received the vaccine & the next day became very weak and ill with throwing up. Her sister came to visit and noticed her right face was drooping & her balance was off so she called ambulance. Subsequently has been hospitalized for a month with a heart failure exacerbation that has led to ICU care, sepsis with Klebsiella pneumonia, acute kidney injury now with long term dialysis, hyponatremia, & elevated liver enzymes
76 2021-02-27 restless legs syndrome Experience symptom similar to restless leg for about half to one hour in evening. Feeling I had to m... Read more
Experience symptom similar to restless leg for about half to one hour in evening. Feeling I had to move lower extremities. Didn't last long.
76 2021-02-28 facial pain Woke up Sunday morning with my face swollen and fire red on the right cheek and rash on the left che... Read more
Woke up Sunday morning with my face swollen and fire red on the right cheek and rash on the left cheek and brow. Right cheek hurts because of the swelling. Took 2 Benadryl at noon. Right cheek is burning. Today is Monday and it is still swollen but not as red. It hurts and got more Benadryl to take. Took 2 at 3pm today.
76 2021-02-28 numbness 10:15- Pt initially c/o left arm numbness sensation, brought back to observation area 10:20- Pt c/o... Read more
10:15- Pt initially c/o left arm numbness sensation, brought back to observation area 10:20- Pt c/o thick throat sensation - Emergency Response Team Called 10:22- Pt c/o increased throat sensation "swelling in back of my tongue and throat" with onset of difficulties breathing- Epinephrine Auto-Injector 0.3mg administered. 10: 26- Emergency Response team arrives 10:28- Pt transported to ER for evaluation
76 2021-02-28 pain in extremity Tinnitus spiked up quite a bit /tinnitus was reported as worsened /her tinnitus increased a great de... Read more
Tinnitus spiked up quite a bit /tinnitus was reported as worsened /her tinnitus increased a great deal. It increased in loudness; arm was sore; stomach ache; upsetting and distressing; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration at 13:30, on right arm, on 25Jan2021, at single dose for COVID-19 immunisation. The patient relevant medical history included heart condition, she is mostly allergic to antibiotics (She has allergies to several medications; Specific antibiotic names not provided), blood pressure, anxiety, thyroid (thyroid disorder), urinary tract health, I have had tinnitus for 7 years and Bones (bone disorder) and of them were ongoing. The patient concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder and ongoing at 50ug, daily, hydrochlorothiazide tablet for blood pressure and ongoing at 0.25mg (half tablet) once a day, valsartan(DIOVAN) for blood pressure ongoing at 80mg once a day, verapamil for heart issue ongoing at 100mg, metoprolol tartrate for heart, ongoing at 25mg twice a day, alprazolam (XANAX) for anxiety ongoing at 0.25mg, once a day, d-mannose for urinary tract health ongoing at 300mg once a day, vitamin d nos for bones ongoing at 50ug daily, calcium carbonate (CALTRATE) for bones at unknown dose once day, ubidecarenone (COQ10) for heart ongoing at 200mg, magnesium for the heart. It was reported that patient got tinnitus after taking an antibiotic and had for 7 years. After taking the first dose on Monday (25Jan2021), the tinnitus spiked up quite a bit on 27Jan2021 (noticed when she woke up at about 08:00 in the morning). Tinnitus got very much louder, and patient thought that it was from vaccine. Tinnitus increased a great deal. It increased in loudness and was reported as worsened. On an unknown date in Jan2021, the patient arm was sore and got better. The patient also had little bit of a stomach-ache at first and that got better as well on an unknown date in Jan2021. The patient thought that the tinnitus would return to my normal level of loud. The patient reported that it's very upsetting and distressing on an unknown date in Jan2021. The patient was worried about getting the second shot. The patient also stated that had allergic reactions to many drugs and did fine with the vaccine in terms of anaphylaxis. It was reported that prior vaccinations within 4 weeks was none. It was reported that patient had not administered additional vaccines on same date of pfizer suspect administration. The outcome of the events tinnitus spiked up quite a bit /tinnitus was reported as not recovered /her tinnitus increased a great deal. It increased in loudness was not recovered, upsetting and distressing was unknown, stomach-ache and arm was sore was recovering.
76 2021-02-28 pain in extremity Developed pain of 10/10 in arm the day after the vaccine which continues to today. MD office visit ... Read more
Developed pain of 10/10 in arm the day after the vaccine which continues to today. MD office visit scheduled.
76 2021-02-28 tingling, flushing Aprox 10 minutes after receiving the vaccine client started c/o stinging and tingling in her hands a... Read more
Aprox 10 minutes after receiving the vaccine client started c/o stinging and tingling in her hands and they were red, she felt flushed. No medications given. She felt better shortly afterwards. She did not let her PCP know of this information.
76 2021-03-02 tremor, numbness head hurt; pain in all of her joints/couldn't move fingers; felt numb; Nauseous; felt unstable; ligh... Read more
head hurt; pain in all of her joints/couldn't move fingers; felt numb; Nauseous; felt unstable; light-headed and dizzy; Sweating; Chills; seemed to not be able to register stuff, she wouldn't necessarily say memory loss, but she couldn't put stuff together; Not hearing correctly; not wanting to eat; She was beginning to feel dehydrated; shaking; equilibrium was off; sleeping for hours; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiry date: 31May2021), via an unspecified route of administration on 29Jan2021 (at the age of 76 years old) at a single dose for covid-19 immunization. Medical history included pre-diabetic, thyroid (disorder), and cholesterol (abnormal). Concomitant medications included levothyroxine from unspecified date to 31Jan2021 as thyroid medication and rosuvastatin for cholesterol. The patient previously took first dose of bnt162b2 (lot number: PFREL1283, expiry date: 30Apr2021) on 08Jan2021 (at the age of 76 years old) at a single dose for covid-19 immunization and experienced Injection arm pain, a little more drowsy than normal, and more tired. On 29Jan2021, the patient experienced sleeping for hours. On 30Jan2021, the patient experienced when she woke up, she thought she was headed for the emergency room (ER) as she had pain in all of her joints. At first, it was only her fingers which lasted for five minutes or so where she couldn't move her fingers, she felt numb, she was very nauseous. she couldn't hold down food, she never threw up though, she felt unstable. If she drank water, she would immediately be going to the bathroom, she was beginning to feel dehydrated. She just couldn't hold it when she had to go to the bathroom. Then, the finger pain went to her joints in her elbows and knees. On 30Jan2021, she was also light-headed and dizzy, she was not wanting to eat, she tried to eat dry toast. She was nauseous in her stomach, but she didn't throw up. She experienced sweating and chills. On late Saturday evening of 30Jan2021, she also had an issue, a very mild case, of not hearing correctly but it was not a ringing in her ear, it was like her equilibrium was off. She ended up putting a little bit of liquid ear drops in her right ear, and that seemed to help it. Right now she feels like she has recovered from everything. When unstable, it didn't seem to last too long, she is in bed most of the time. By the time she got up to eat, she was fine. But then she lapsed into chills and shaking. The patient also experienced she seemed to not be able to register stuff, she wouldn't necessarily say memory loss, but she couldn't put stuff together (30Jan2021). She can remember stuff now and it only lasted that day. On 31Jan2021, her head hurt. Therapeutic measure was taken as a result of the event a very mild case, of not hearing correctly. Outcome of events felt unstable, light-headed and dizzy, memory impairment was recovered on 30Jan2021. Outcome of the events arthralgia, felt numb, nauseous, head hurt, sweating, chills; not hearing correctly, not wanting to eat, dehydration, shaking and equilibrium was off was recovered on 31Jan2021. Outcome of event sleeping for hours was recovering.
76 2021-03-06 feeling cold Very cold, chills, many many trips to the bathroom, flu-like very upset stomach, 101 temp, throw... Read more
Very cold, chills, many many trips to the bathroom, flu-like very upset stomach, 101 temp, throwing up ,
76 2021-03-07 difficulty speaking pustules across her back; In her throat she is getting hoarse; itching with the rash; rash that is a... Read more
pustules across her back; In her throat she is getting hoarse; itching with the rash; rash that is all over her body; splotches on her belly on her right side, right below her waist /Two splotches on right hand side; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), via an unspecified route of administration at left upper arm on 26Jan2021 at 14:19 at SINGLE DOSE for COVID-19 immunisation. The patient had no previous immunizations. The patient had no prior vaccinations within 4 weeks and no additional vaccines administered on the same date. Medical history included allergic to penicillin, bladder infection, in the middle of her chest she had the pain cling through her back, and thyroid getting lazy and does not work. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), levothyroxine sodium (SYNTHROID) for thyroid getting lazy and does not work, vitamins, and sulfa drugs for bladder infection. It was reported that after getting the first dose of the vaccine the patient noticed she had pustules across her back on an unspecified date. The patient stated she "got this rash from the tips of fingers, even the palm of my hands and it starts right under the neck and goes across my breast, on my belly, on my back and both arms and is now halfway down my shin bone." On an unspecified date in Jan2021, she noticed this the afternoon of her vaccine around 7:00 when she saw two splotches on her stomach and it kept spreading. Sunday morning she went to Quick Care and yesterday went to her regular doctor. Her doctor gave her prednisone to take 10 mg 4 times a day, and hydroxyzine 10 mg for itching. In her throat she was getting hoarse on an unspecified date and was keeping a water bottle on her desk to keep hydrated. She stated she read on (website) that a rash can be a symptom of the vaccine. The caller asked, "if the pustules burst will this cause anyone to get Covid 19? Is this a possible side effect of the vaccine? How long will this last? Is it okay to get my second shot with this reaction? Is there anything I should be taking to make it go away?" It was further reported that patient received paperwork to call if there was any type of reaction. The patient mentioned she has a rash that was all over her body on 28Jan2021. It was on the top of her hands, in the palm of her hands, on her arms, back, under her breast, on her chest, on her stomach, on her bottom end, it was going down her legs and to her knees at this point. The patient initially stated she noticed the rash on Friday (29Jan2021), she later stated it was Thursday 28Jan2021 when the rash first started. She stated she first noticed splotches on her belly on her right side, right below her waist on an unspecified date in Jan2021. At first when looking at it she did not think too much about it. Later in the call she further clarified and stated it was possible she noticed these splotches the same day in the evening on the day she got the vaccine. She was not sure. If it was not the same day it was the next day. Friday (29Jan2021), she started to get as initially stated bumps, but later clarified rash under skin and it really proceeded from there. Additionally, it was reported that the rash continued to spread throughout her whole body. It was down to her shin now. Her whole upper body was horrible. She has some across her back. There are pustules on them like a pimple. It was like water in it ready to break. Sunday she went to a (clinic name) to get it looked at. She went Sunday 31Jan2021. She was given an intravenous (IV) and three needles were placed in it. She knows one was a steroid, she does not know what the other two were for, but she thinks one was probably for itching. The patient also confirmed she also experienced itching with the rash on 28Jan2021. It started the same day she noticed the rash. The patient stated it was like a full blown case now. The itching was with the rash on 28Jan2021. The itching and rash has continued to go down her body. It was on her buttocks now. It was hard to sit. It was in private up between her legs and stuff. Her body was almost 80 % full and covered with this stuff. She saw her regular doctor yesterday. The doctor at (clinic name) thought this reaction may have been an allergic reaction to a Sulfa drug she was taking for a bladder infection coincidentally at the same time, but she does not believe this was the case. Stated she had taken that sulfa drug before previously. She does not have the name of the drug to provide of the sulfa drug. She does not have it with her. No blood work was done. She was just looked at. They saw what was going on. The patient also mentioned she went on the internet to do research. She saw on Pfizer page three pictures that resembled what she had going on. It was also reported that the two splotches on right hand side started about 7'clock in the evening. At first did not think anything of it. Thought it was possibly a bug bite at first. Additionally, it was reported that patient went to see a doctor. She was already going to the doctor for a bone density scan and she showed the doctor what was going on at the same time. Her primary doctor thought this was due to the COVID 19 Vaccine. At end of call, patient questioned "if the pustules across upper back and behind neck, will that cause anyone to get COVID 19? Side effect?" The patient had no emergency visit. Therapeutic measures were taken as a result of itching with the rash, rash that is all over her body, and two splotches on right hand side. The patient had not yet recovered from rash that is all over her body while outcome of the events pustules, itching with the rash, in her throat she is getting hoarse, and "splotches on her belly on her right side, right below her waist /Two splotches on right hand side" was unknown.
76 2021-03-07 pain in extremity only sore arm; feeling tired; This is a spontaneous report from a Pfizer-sponsored program from a co... Read more
only sore arm; feeling tired; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (reporting for herself). A 76-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration (at the age of 76) single dose on 02Feb2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced only sore arm and feeling tired both on an unspecified date. She has had to take a nap everyday since. The outcome was unknown. Information on the lot/batch number has been requested.
76 2021-03-08 feeling hot Became nauseous with headache within one hour of getting vaccine, developed irritable bowels third d... Read more
Became nauseous with headache within one hour of getting vaccine, developed irritable bowels third day after, and became extremely hot the morning of the fourth day after the vaccine and again on the seventh day after the vaccine. The nauseous, headaches, and irritable bowels subsided by fourth day after the vaccine. Did not receive any treatment.
76 2021-03-08 pain in extremity At the time of the injection a small red area was identified. There was mild pain in my arm for a da... Read more
At the time of the injection a small red area was identified. There was mild pain in my arm for a day or two. Six days later the red area has became about four times larger and spread around. Pain is still mild- the upper arm is sore and itchy.
76 2021-03-09 numbness Numbness in upper and lower jaw. This occurred about 15 min. after vaccination and lasted about 45 m... Read more
Numbness in upper and lower jaw. This occurred about 15 min. after vaccination and lasted about 45 min.
76 2021-03-09 pain in extremity I developed arm pain, up my arm to my neck, Then 2 days later developed a rash on my wrist, arm and ... Read more
I developed arm pain, up my arm to my neck, Then 2 days later developed a rash on my wrist, arm and top of my back.
76 2021-03-09 pain in extremity Sore arm, extreme fatigue, fever 101.9 and loss of appetite for 2 days following vaccine. aching beh... Read more
Sore arm, extreme fatigue, fever 101.9 and loss of appetite for 2 days following vaccine. aching behind eyes, especially right eye which lingered until about day 7, headache on right side for about last 4 of the 7 days, some discomfort in right armpit and tenderness of right breast nipple. No treatment except fluids and bed rest for first 3 days. By day 6 I felt myself again.
76 2021-03-09 pain in extremity Heavy, aching legs from the knee down. Knees throb. Right shoulder intermittent aching. Walking affe... Read more
Heavy, aching legs from the knee down. Knees throb. Right shoulder intermittent aching. Walking affected in that the aching reduced distance I could comfortably cover. Dragging body after a walk beyond a quarter of a mile. worst symptoms in the evening and night. Sleep disturbed on many nights. tylenol helped but did not always allow for a good sleep.
76 2021-03-09 pain in extremity arm is still aching/right arm continues to throb; This is a spontaneous report from a contactable co... Read more
arm is still aching/right arm continues to throb; This is a spontaneous report from a contactable consumer (patient herself). This 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration, on 19Jan2021 (at 16:00, at the age of 76-years-old) at a single dose on the right arm for COVID-19 immunization, administered at hospital. No other vaccine was received in four weeks. No relevant medical history was provided. Past drug history included allergy to sulfur. Relevant concomitant medications included losartan.The patient stated 'my arm is still aching/right arm continues to throb'. The patient had not recovered from the event.
76 2021-03-10 weakness nauseated; feeling weak and not well; feeling weak and not well; allergic to an ingredient in the va... Read more
nauseated; feeling weak and not well; feeling weak and not well; allergic to an ingredient in the vaccine: polyethylene glycol; rectal bleeding which then became rectal hemorrhage; stomach cramps; bowel movements; diarrhea; This is a spontaneous report from a contactable consumer. A 76 years old female consumer reported that she received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on the 12Feb2021 at around 04:30PM single dose for COVID-19 immunisation. Medical history and concomitant drugs were not provided. At midnight that same day on 12Feb2021, she started getting stomach cramps, bowel movements, diarrhea, rectal bleeding which then became rectal hemorrhage. She did not go to the hospital. She said the effects dissipated; however, she still felt nauseated today (26Feb2021). The patient was currently taking ondansetron (ZOFRAN). She has been feeling weak and not well. She had a colonoscopy planned soon. She's concerned about receiving the second dose. She mentioned as well that she believed she was allergic to an ingredient in the vaccine: "polyethylene glycol". Outcome of nausea was not recovered. Outcome of other events was unknown. Information about lot/batch number has been requested.
76 2021-03-11 hot flush I had 4 hot flash through the day.
76 2021-03-14 weakness Sweating; Weakness/too weak; loss of appetite; Chills; Headache; Nausea; felt sick; This is a sponta... Read more
Sweating; Weakness/too weak; loss of appetite; Chills; Headache; Nausea; felt sick; This is a spontaneous report from a Nurse (Patient). A 76-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number, Expiry Date: unknown, NDC number: unknown), on right arm, via an unspecified route of administration on 08Feb2021 at single dose for covid-19 immunization. Covid vaccine was a Pfizer product. Covid vaccine manufacturer was unspecified. No lot number of Covid vaccine was not provided as complainant (patient) does not have the product with them at the time of call. Medical history included Heart attack five years ago, Open heart surgery four years ago, Pulmonary hypertension about 10 years ago, Diastolic dysfunction about 10 years ago. The patient's concomitant medications were not reported. Age at time of onset event was 76 years. Caller (patient) stated that on Monday 08Feb2021, she had her first dose of the Pfizer Covid vaccine and what happened was she waited 15 minutes and the girl came and she said she was fine which she was and she went and sat on the chair and in an hour and a half, she started to feel sick and had a slight headache, and nausea, about an hour and half later it went away. Stated the next morning she got up, sort of too weak to get out of bed, went to the bathroom and went bed and woke up about 5 hours later, felt alright, not so bad. Still did not feel very strong and she sat in her recliner and she was playing on her tablet and she didn't have an appetite, and then she got the chills and then after she got the chills she had to take everything off because she started to sweat. Did not have the strength to go get her thermometer, after she started to sweat she started to feel fine. Caller would like to know if she should get the second dose. NDC, Lot, and expiration date unknown, caller does not have her patient card. The patient experienced sweating, weakness, loss of appetite, chills on 09Feb2021; felt sick, headache, nausea on 08Feb2021. The outcome of the event sweating, weakness, chills was recovered on 09Feb2021; nausea, felt sick, headache was recovered on 08Feb2021; loss of appetite was not recovered (still ongoing). Information regarding lot/batch number has been requested.
76 2021-03-14 pain in extremity Initial nausea, aches and chills and very sore arm. Two days following shot allergic reaction in th... Read more
Initial nausea, aches and chills and very sore arm. Two days following shot allergic reaction in the form of hives and itching on lower extremities and slightly on lower side of upper arms. (No adverse reaction to first shot)
76 2021-03-14 tenderness, pain in extremity Terrible nightmare during night of injection. Smothering and paralyzed feeling. Shouting out in my ... Read more
Terrible nightmare during night of injection. Smothering and paralyzed feeling. Shouting out in my sleep. Husband finally woke me . When I got up to take a Motrin I was disorientated. Did not know where I was. . Next day experienced several sudden feelings a syncopye. Lasting a few seconds. Had to grab on to something due to a feeling that I was going to fall. It lasted just a quick second or two. Happened several times that day. Like what I would think a TIA would feel like. Arm was just slightly tender and stinging the first day,. In the night it was aching and hot up into my neck. The next morning it was fine again. Just tender and a little stiff. I attempted to report this on line at instructed on forms given me when I left the site. however the CODE that was to be sent to my phone never came. I then entered the wed site and attempted to report it there. . Finally I called my primary Dr and he has instructed me to report this to the person giving the second injection. I doubt they will know what to do seeing as they are volunteers with little experienc.e
76 2021-03-15 cold extremities, numbness Pain and swelling (about the size of a boiled egg) on the shot site; Pain and swelling (about the si... Read more
Pain and swelling (about the size of a boiled egg) on the shot site; Pain and swelling (about the size of a boiled egg) on the shot site; Cold hands and feet after receiving shot; My right hand also was numb and needed to be rubbed to increase circulation; Fever; joint aches; headache; This is a spontaneous report from a contactable consumer reported that: A 76-years-old female patient received bnt162b2 (BNT162B2; Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9261) as SINGLE DOSE for COVID-19 immunisation. Medical history included cerebrovascular accident, allergic to sulfa drugs (drug hypersensitivity). The patient received concomitant medications included losartan (LOSARTAN), atorvastatin (ATORVASTATIN), vitamin b12 nos (VITAMIN B 12 [VITAMIN B12 NOS]), acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were unknown. The patient did not receive any other vaccines with in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 03:00, the patient experienced Pain and swelling (about the size of a boiled egg) on the shot site. Cold hands and feet after receiving shot, including all night. My right hand also was numb and needed to be rubbed to increase circulation. Fever, joint aches, headache. The patient underwent lab tests and procedures which included body temperature: results unknown .Outcome of the events were recovered on unspecified date.
76 2021-03-16 weakness generalized weakness, subjective chills, fever, diarrhea
76 2021-03-17 weakness A cough began 3 days after the vaccine. On the 4th day I woke up with a fever, heavy cough and heavy... Read more
A cough began 3 days after the vaccine. On the 4th day I woke up with a fever, heavy cough and heavy head cold. I slept the whole day. The fever was gone by morning of the 5th day, but I felt like a piece of "rubber" the following 2 days. The cough has lingered until today (2 weeks after the first vaccine).
76 2021-03-17 bell's palsy Bells Palsy
76 2021-03-17 flushing Facial flushing, facial swelling, especially around eyes
76 2021-03-17 tremor tremor and chills onset last night, body rigid, could not sleep
76 2021-03-18 weakness, involuntary muscle movements, tremor diarrhea; color of the diarrhea looked red and looked like it had blood on it; she sat down in a cha... Read more
diarrhea; color of the diarrhea looked red and looked like it had blood on it; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; shaking/trembling out of control; hurting from her neck down to her toes; joints were achy, hurt, and stiff; joints were achy, hurt, and stiff; her teeth were chattering and cant stop, and when she tried to stop that it made it worse; she had hard time walking/Her gait was off and she was kind of jerking; fell in the bathroom; she was too weak; hard time rolling and trying to get out of bed; Her gait was off and she was kind of jerking; little nausea; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea; she was kind of wiped out for a couple of days (in 2021) and it was all over now; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6203), via an unspecified route of administration in left arm on 27Feb2021 (at the age of 76years) as single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia diagnosed in 1999; Covid-19 from 23Nov2020 to Dec2020 (went to the hospital because of pain in her side at night. Was told she had pneumonia and pleurisy, she got it 2 days after her husband did, but hers was a mild case); her husband had Covid in Nov2020 and died in Dec2020 and hemorrhoids (from having babies years ago). Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN). The patient had no investigation assessment. The patient scheduled her first dose for 27Dec2021. The patient had questions about it, but the person administering it did not speak English and she said that initially she did not have any reactions while she was there. The patient received the first dose of the vaccine on 27Feb2021 and has a lot of adverse events. After the getting the shot, she woke up at 0400 and experienced shaking (whole body was shaking), trembling out of control, hurting from her neck down to her toes, her joints were achy, hurt, and stiff, her teeth were chattering and couldn't stop, and when she tried to stop that it made it worse, when she got up she had hard time walking, so much that when she had diarrhea, she had diarrhea on the floor, she also noticed that the color of the diarrhea looked red and looked like it had blood on it but she was not sure. After that, she sat down in a chair and noticed that it had blood when she got up and suspected that she had hemorrhoids and bleeding because of the diarrhea. She thought it was a result of the reaction to the shot. She noted that that she had COVID on 23Nov2020 and that she heard that people who had COVID might not need to get the second shot but it was only speculation so she was asking if this was true. She mentioned that she waited 90 days before getting the vaccine as per CDC guidelines and knew that the 2nd dose can be given for 42 days after the first dose. The patient's daughter in law who was an occupational therapist volunteered to fly in and take care of her after the second shot on 27Mar2021 but her 2nd shot was due on 20Mar2021 so she wouldn't be there until then. The patient was having a hard time rescheduling her appointment so asked if there was anything can be done. The patient would prefer not to take the second dose due to the side effects. The patient also reported that it looked like someone who had a stroke trying to walk again, her gait was off and she was kind of jerking. As she would take a step her foot would go down on a slant like it was skidding. She said that this happened one other time to her. It was like she was leaning forward and could not stop herself. When she was able to get up, she went into the living room and sat in her husband's chair and fell asleep until 15:00. When she got up, she noticed a lot of blood in the chair. The patient asked if this was allowed. She went home and took a couple of acetylsalicylic acid, caffeine, paracetamol because she did not have paracetamol (Tylenol), and she went to sleep. She had a hard time rolling and trying to get out of bed. She turned on her electric blankety and her heat. She said that by 0600 most of the shaking had gone away. She felt a little nausea, but got some dry toast. She said that she wanted to take a shower, but she started getting diarrhea from the injection. She fell in the bathroom and could not get herself up for over an hour because she was too weak. When she fell on the floor, she tried to get on a rug because she was still having the diarrhea on the floor. She said that it was everywhere. The next day she called her son and his wife they said that she could be alone for her second shot. She was scheduled for 20Mar2021 for her second dose. The patient had a hard time changing the appointment and her son could not come to stay with her until 27Mar2021. A friend told the patient that on the news it said that a second shot may not be necessary for people who have had Covid-19 already and she wanted to know if Pfizer has heard of this. The patient said that she was kind of wiped out for a couple of days (in 2021) and it was all over now. The doctor's office was aware of what happened and she was told to take extra strength Tylenol before and after the second injection to address these symptoms. The consumer considered the case as non-serious. The outcome of the event fatigue was recovered in 2021 while for the remaining events was unknown.
76 2021-03-20 feeling hot Headache and was hot; really hot at night; Really strong muscle and joint aches/pain; Really strong ... Read more
Headache and was hot; really hot at night; Really strong muscle and joint aches/pain; Really strong muscle and joint aches/pain; fever; White bump near injection site.; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL9262 and expiry date: 31May2021) via Intramuscularly to left arm on 22Jan2021 10:30 at single dose for COVID-19 immunization. Patient medical history included bladder infection, blood pressure, she has some old age stuff like blood pressure, and she had Thyroid removed and takes a thyroid pill every day and she tends toward GERD. Concomitant medications included she does take other medications, but they are not relevant. Patient previously took Shingles shot for Shingles (Had the first of the Shingles shot but it was before that. She is due for the second one but she is putting it off for the COVID second dose). Patient reported that she got the COVID vaccine and was really excited because seemingly, she had no side effects. The shot did not hurt. Ten days after she go the shot, she got really hot at night and really strong muscle and joint aches on 31Jan2021. She was up almost all night. It just kept waking her up. So, she took something, an Ibuprofen thing to reduce fever and pain. The next night she took one proactively and did not have pain. The third night, she had it again but it was a headache all night and she was hot on 02Feb2021. It only seemed to happen at night. She felt like it was from the vaccine. She was not worried she had COVID. She had no breathing problems and did not feel like she was going to pass out. They said she should wait 48 hours and take a test to see if she had COVID. She did and it was negative. She does not feel any negativity toward the vaccine. She went in for a bladder infection and it was from a doctor's appointment that she got information and they told her she could go ahead and get it. Since she got the vaccine, she got white bump in the vicinity of the vaccine like a while mole, and another in the vicinity of the area as well. It does not itch or hurt. She noticed it about a week after the shot. She does not know the date. She was still on medication for a bladder infection but it would not have done anything. When she had reaction to the vaccine, it was already 10 days after she got the shot. She had asked them at Kaiser, and they think it was unrelated to any other medication. Outcome of event fever was recovered on 01Feb2021, for white bump near injection site was not recovered and recovering for all other events.
76 2021-03-20 pain in extremity Severe joint pain especially in feet, ankles, knees; Severe joint pain especially in feet, ankles, k... Read more
Severe joint pain especially in feet, ankles, knees; Severe joint pain especially in feet, ankles, knees; chills; headache; Pain was severe enough as to interfere with sleep; This is a spontaneous report received from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL1283) via an unspecified route of administration to left arm on 18Jan2021 13:00 at single dose for COVID-19 immunization. Patient medical history included high blood pressure and Allergy to tomatoes/walnuts. Concomitant medications included Lisinopril, Metropolol and Hydrochlorothiozide. On 26Jan2021 patient experienced with severe joint pain especially in feet, ankles, knees; chills, headache. Pain was severe enough as to interfere with sleep. Patient did not receive any treatment for the events. Seriousness was reported as non-serious. Outcome of events was not recovered.
76 2021-03-21 weakness Phizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, headache, chills, fever, nausea... Read more
Phizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, headache, chills, fever, nausea, feeling unwell, dizziness & weakness
76 2021-03-21 facial paralysis, bell's palsy EUA Pfizer -BioNTech vaccine 3 days after vaccine, patient complained about facial droop. She saw... Read more
EUA Pfizer -BioNTech vaccine 3 days after vaccine, patient complained about facial droop. She saw her PCP who diagnosed her with Bell's Palsy. She was prescribed acyclovir and prednisone. 4 days after the vaccine, she began to feel dry eyes, and difficulty swallowing. She was advised that symptoms will improve with time and steroids and to return to the ED if she experiences voice changed or cannot tolerate liquids.
76 2021-03-21 feeling hot 2 degree temperature and feeling hot; arm swollen with egg size lump; rash on arm 2inch x 4 inch; ex... Read more
2 degree temperature and feeling hot; arm swollen with egg size lump; rash on arm 2inch x 4 inch; extreme fatigue ; red cheeks; and 10 days later JAW HURTING which persists to date
76 2021-03-24 difficulty speaking SCRATCHY, GRAVELY THROAT; IRRITATION OF VOICEBOX; SOUNDS "FROGGY"; HARDER TO SPEAK AS DAY GOES ON, W... Read more
SCRATCHY, GRAVELY THROAT; IRRITATION OF VOICEBOX; SOUNDS "FROGGY"; HARDER TO SPEAK AS DAY GOES ON, WORSE IN EVENING; HURTS TO TALK. HAS HAD SIMILAR SYMPTOMS IN PAST BUT BROUGHT ON BY STRONG SCENTS/SMELLS (HAS HYPERSENSITIVITY TO SMELLS) AND RESOLVES WHEN SHE IS ABLE TO GET FRESH AIR. THESE SYMPTOMS STARTED ABOUT 24 HOURS AFTER VACCINE AND HAVE STILL NOT RESOLVED AS OF TODAY PER PATIENT. HAS CALLED DR. 2 TIMES AND WAS SEEN ONCE IN HIS OFFICE. HAS TAKEN A ZPAK.
76 2021-03-24 facial pain, pain in extremity Back hurt a tremendous amount; Lower back, hips, knees, neck pain; Lower back, hips, knees, neck pai... Read more
Back hurt a tremendous amount; Lower back, hips, knees, neck pain; Lower back, hips, knees, neck pain; When she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes.; Very sore, uncomfortable stomach; Exhausted; Chills; Felt like she was having a heart attack; a bit congested; Aches; jaw pain; facial pain; Quite a bit of saliva in her mouth, it filled up quite a lot; sore on the injection site; Bit of a sore arm/left arm pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Right Arm on 02Mar2021 14:26 (Batch/Lot Number: EN619G) as single dose for vaccination. Medical history included joint replacements (specified as 1 hip done in 2007; right knee done in Jan2013; another knee was done in Feb2017; another knee was done in 1986); and in 2011, neck fracture. There were no concomitant medications. The patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and on 02Mar2021, she had sore on the injection site, experienced excess saliva production. On 05Mar2021, she experienced chills, feeling of heart attack: left arm pain, jaw pain, facial pain. She is worried to take the 2nd shot as she might have more symptoms on the 2nd dose. On an unspecified date, the patient had lower back, hips, knees, neck pain, eye socket hurts when rolling her eyes, sore stomach, and exhausted. It was also reported as follows: on 02Mar2021 after she got home from being administered the Pfizer-BioNTech COVID-19 Vaccine she had quite a bit of saliva in her mouth, it filled up quite a lot; and a bit of a sore arm for a couple of days but that was about it at that point. On Friday, 05Mar2021 she started getting chills and aches; and felt like she was having a heart attack: her left arm hurt and her left side of face hurt down in her jaw. She was afraid and considered going to the hospital but thought she was going to wait it out see what it is and it passed. She then once again got a lot of saliva in her mouth again. Over the next few days she developed aches that were primarily located in her joint replacements, it seemed like the aches attacked those areas of joint replacements in her hips, knees and where she had a neck fracture. She had a lot of pain and a lot of chills. She was never bedridden, but would lay down because she was exhausted. Her back hurt a tremendous amount. Another thing that happened is her eyes, when she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes; she did not have a headache; this whole indentation there with her eyes hurt to move them from one side to another. She also had a very sore, uncomfortable stomach; it was not an upset stomach; just seemed very sore, uncomfortable. At first that first part of 05Mar2021 she seemed a bit congested. She is very worried about second dose of Pfizer-BioNTech COVID-19 Vaccine because of the first dose creating all of these difficulties. She does not know what she should be doing. She is scheduled to get her second dose of the Pfizer-BioNTech COVID-19 Vaccine on 24Mar2021 because she is leaving by plane on 29Mar2021. That only gives her like 4-5 days before she leaves and she knows that the other symptoms after the first dose of the Pfizer-BioNTech COVID-19 Vaccine did not start until 3 days later. She is concerned about that, because she is flying to take care of her sister; she is worried about the second dose because she does not like what she experienced with the first dose because she heard that the second dose will be terrible; she is worried about leaving and experiencing those horrible things. She reported that there are no tests/investigations relative to this report to provide. The only thing recently done was having X-rays of her neck on 24Feb2021 because of her neck issues with the fractured neck she had in 2011. Outcome of the events was unknown.
76 2021-03-24 muscle spasms, fibromyalgia I think I am having a bad reaction to my covid shots. The first shot was 1/31; a week later on 2/7 ... Read more
I think I am having a bad reaction to my covid shots. The first shot was 1/31; a week later on 2/7 I started having headaches that travel around my head: some are behind my eyes and my teeth ache; some more like migraines that go up the back of my head; some more on the top of my head or on the side. My sense of taste changed. My second shot was 2/27. The day after I slept all day. The headaches continued (I have had a headache of one kind or another since 2/7). I had a tooth that broke off last June and was removed on March 8. I thought the tooth was infected and part of the headache problems, but since then I have been having really bad fibro pain and for the week of 3/8- 12 I ran a fever, had chills and more headaches. I was on amoxicillin from 3/8 to 3/14, but the tooth was not that badly infected and is healing well. The headaches do not seem to relate to the tooth. I have had a headache every day since 2/7 of various intensity and in different areas of my head. I am extremely fatigued and need to nap some days. My fibromyalgia symptoms are worse than they ever have been and some nights keep me awake. I also muscle stiffness and spasms in my neck occasionally. This is not normal for me. I saw a ARNP on 3/16 and she tested me for neurologic symptoms. Here are her notes: NEUROLOGIC: negative findings: speech normal, mental status intact, cranial nerves 2-12 intact, gait, including heel, toe, and tandem walking normal, Romberg negative, muscle tone normal, muscle strength normal, rapid alternating movements normal, finger to nose normal, reflexes normal and symmetric I have a video appointment with my primary care provider 3/26 to discuss this further
76 2021-03-24 pain in extremity chest, back underarm pain; chest, back underarm pain; back pain; adhesions; Inflammation numbers wer... Read more
chest, back underarm pain; chest, back underarm pain; back pain; adhesions; Inflammation numbers were high; Clotting numbers were way high over 2000; pneumonia; This is a spontaneous report received from a contactable consumer. A 76-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in right arm on 01Jan2021 11:45 at single dose for COVID-19 immunisation. Medical history included thyroid, pancreas, and known allergies: Sulfa, k-flex, macrobid, statins, and pork. Concomitant medications included levothyroxine sodium (L-THYROXINE CAMPUS), vitamin B3, magnesium sulfate, and unspecified blood thinners. The patient experienced chest, back underarm pain two week later and did not get better. Patient had some adhesions and thought maybe from that. Patient had surgery and did not help. Pain kept getting worse. ED visit. On 04Mar2021, patient was diagnosed with pneumonia and sent home. After antibiotic, patient was no better. Another ED visit on 08Mar2021, clotting numbers were way high over 2000. Inflammation numbers were high. Patient was admitted every test available. 3 days in hospital. Patient was no better. Pain was terrible. Chest underarms and upper back. Patient was in serious pain and afraid to get second shot. Patient had cancelled. These adverse events were result in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. This case was reported as serious with seriousness criteria-caused/prolonged hospitalization. The patient underwent lab tests and procedures which included several computerised tomogram (CT scan): unknown results on an unspecified date, COVID test (nasal swab): negative on 08Mar2021, and X-ray: unknown results on an unspecified date. Patient was treatment for the adverse events. Outcome of the events was not resolved. Information on the lot/batch number has been requested.
76 2021-03-26 weakness Headache, nausea but no throwing up, tiredness, lack of energy, soreness at the sight of the injecti... Read more
Headache, nausea but no throwing up, tiredness, lack of energy, soreness at the sight of the injection. Feeling generally bad all over, aching muscles, much like the symptoms of the covid 19 but only lasted a day and a half. I had covid in December through the new year and it last 3 1/2 weeks.
76 2021-03-27 slurring The patient's daughter called to report her mother developed a swollen tongue the evening after her ... Read more
The patient's daughter called to report her mother developed a swollen tongue the evening after her second covid vaccination. It was mild at first but progressed to the point that it was interfering with the patient's speech. Her breathing was not affected. The swelling did subside some when the patient took allergy medication. I recommended the patient be seen by a doctor, and her daughter agreed, but the patient was not keen on seeking medical care.
76 2021-03-27 feeling cold, tenderness, pain in extremity she did not have a reaction to first. After the second she got very cold and felt miserable like her... Read more
she did not have a reaction to first. After the second she got very cold and felt miserable like her legs had weights on them- this only lasted 1-2 days. Then two weeks later she got a ring around the injection site- and developed intense itching, burning, and erythema and warmth at the site and axillary lymph node swelling. The muscle on her arm were tender and swollen as well. The lymphadenopathy, and arm pain and swelling lasted for over a month. Pfizer : Lot: 12831/8/21 Lot 9261 1/25/21
76 2021-03-28 weakness COVID VACCINE BREAKTHROUGH CASE - COVID SYMPTOMS WITH POSITIVE COVID PCR TEST GREATER THAN 2 WEEKS F... Read more
COVID VACCINE BREAKTHROUGH CASE - COVID SYMPTOMS WITH POSITIVE COVID PCR TEST GREATER THAN 2 WEEKS FOLLOWING 2ND DOSE OF VACCINE; SYPTOMS INCLUDE DIARRHEA, ANOREXIA, WEAKNESS, VOMITING, COUGH, SHORTNESS OF BREATH
76 2021-03-28 weakness Pt is presenting today for Shortness of Breath (pt reprted soa, back pain ( due to rehab 2 weeks ago... Read more
Pt is presenting today for Shortness of Breath (pt reprted soa, back pain ( due to rehab 2 weeks ago), nausea, stomach pain, bilateral ankle swelling, drainage in back of throat, right ear is clogged), Pt was admitted to hospital for AMS last month, uncertain underlying cause. Over past few days shes gotten more weak, possibly more confused, more back pain, and lost voice, some congestion and ear congestion. Her son is managing medication. She has SOB and nausea too. No vomiting or diarrhea. Symptoms worsening. No sick exposures, 1st covid shot 2 days ago
76 2021-03-30 feeling cold, pain in extremity On Sunday at 10:00PM she checked her temperature and it was 100.6 degrees; she was cold, and had her... Read more
On Sunday at 10:00PM she checked her temperature and it was 100.6 degrees; she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly; she felt some slight joint pain in her left knee; she didn't feel good; she felt off balance after receiving her second COVID-19 Vaccine dose. She said she only felt off balance the first day after she received her second vaccine shot.; felt a little off; Chills; Ache; Headache; Injection site pain; soreness under her left arm; This is a spontaneous report from a contactable 76-year-old female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264), via an unspecified route of administration on 06Feb2021 17:15 at single dose in arm left for covid-19 immunization. The patient historical vaccine included BNT162B2 on 16Jan2021 for COVID-19 immunization and he she had Injection site pain (Lot Number: EL3247, Expiry Date: Unknown, Route: Intramuscular, Anatomical Location: Arm, Left, No. of Previous Doses: None) and about 10 years ago she had a flu shot, and she had a reaction that felt like she got the flu for a day. On 07Feb2021, the patient woke up and she felt a little off in the morning. On Sunday afternoon, between 1:00-2:00PM, she had chills, felt achy, slight headache and she didn't feel good. She said she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly. She said it dawned on her at 10:00PM Sunday night that maybe she had a temperature. She said she checked her temperature, and it was 100.6 degrees. She said she called to ask a nurse if she could take Tylenol for her fever. She said she had read about not taking Tylenol with the COVID-19 vaccine, but nurse told her it was OK to take Tylenol. She said she felt some slight joint pain in her left knee, too. The patient stated that she had a little bit of injection site pain with her first COVID-19 Vaccine shot. She said she thought the injection site pain was due more to where the COVID-19 Vaccine shot was given, and not from the COVID-19 Vaccine itself. She said with her second COVID-19 Vaccine shot, she had pain at the injection site and soreness under her left arm. The patient took the generic Tylenol Pain Reliever 325mg for her fever and chills. The outcome of the event felt a little off, ache and didn't feel good recovering on an unknown date, chills, headache, temperature was 100.6 degrees resolved on 08Feb2021 and she was cold, had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly were resolved on 08Feb2021. injection site pain and soreness under her left arm resolved on 10Feb2021 and She said she only felt off balance resolved on 07Feb2021.
76 2021-03-30 pain in extremity has been experiencing high sugar level; having pain at tip of radius- sore to touch. Very sore; join... Read more
has been experiencing high sugar level; having pain at tip of radius- sore to touch. Very sore; joint pain; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and via sponsored program . A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included diabetic. The patient's concomitant medications were not reported. The patient previously took steroid shots that cause blood sugars to sky rocket, but that was expected. The patient stated, "about the time I got the shot, started having pain at tip of radius- sore to touch. Very sore. No trauma there. It doesn't comes and goes. I'm aware of it" on 23Feb2021. The patient also said she has had increased blood sugars since the vaccine (readings of 197, 147, 154) on 23Feb2021. The patient further stated that she was looking at book and has had higher numbers of 197,147 and 154. Stated that she was usually 120 or below. Stated that she does not know if it had anything to do with it. Stated that the tip of her radius was terribly sore to the touch. Stated that it said that joint pain was a side effect on an unspecified date in 2021. Patient wanted to know if it was a side effect or just her own aches and pains. The outcome of all events was unknown. Information on the lot/batch number has been requested.
76 2021-03-30 pain in extremity My right hand started hurting in the afternoon where it would hurt when I closed my hand; This is a ... Read more
My right hand started hurting in the afternoon where it would hurt when I closed my hand; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; batch/lot number and expiration date were not reported) via an unspecified route of administration in the morning of 16Mar2021 (at the age of 76-years-old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In the afternoon of 16Mar2021, the patient's right hand started hurting where it would hurt when she closed her hand and it has not gone away. The patient asked how long for the pain to go away. The patient was referred to health care practitioner(HCP) provider for additional guidance. The outcome of this event was not recovered. Information on the lot/batch number has been requested.
76 2021-03-31 weakness sick to stomach, generalized weakness
76 2021-04-02 hot flush nauseas; hot flashes; slight sore throat; feel a little punk; slight soreness at injection site in m... Read more
nauseas; hot flashes; slight sore throat; feel a little punk; slight soreness at injection site in my left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EL9264; Expiration Date: unknown), dose 1 via an unspecified route of administration in Arm Left on 04Feb2021 09:00 as SINGLE DOSE for COVID-19 immunization. Medical history was unknown. There were no concomitant medications. The patient experienced slight soreness at injection site in my left arm (vaccination site pain) on 04Feb2021 with outcome of recovered, feel a little punk on 08Feb2021 with outcome of unknown, nausea, hot flashes, slight sore throat on 09Feb2021 with outcome of not recovered. The patient is scheduled for the second dose on 25Feb2021. No follow-up attempts are possible. No information is required.
76 2021-04-04 muscle spasms Day 5 and still have symptoms. Leg spasms like charlie horses from my knees (both replacement knees)... Read more
Day 5 and still have symptoms. Leg spasms like charlie horses from my knees (both replacement knees) up through my thighs to my hips, pretty much 24/7. Chills, loss of apatite and some foods taste strange. have been unable to sleep through the night because of the pain.I do think that the antibiotic did not mix with the second shot even though the medical staff cleared me at the COVID clinic that I could have the shot.
76 2021-04-05 weakness Received dose and tolerated it well. Over last week increasingly SOB, diarrhea and weakness. Of note... Read more
Received dose and tolerated it well. Over last week increasingly SOB, diarrhea and weakness. Of note family contact tested positive for She was admitted to the hospital - c Patient admitted to COVID unit as PUI, tested positive for COVID on 3/7. Required O2 and intubated with ICU admission. She remained intubated for 12 days. Her ICU course was complicated ARDS with severe hypoxemia, A.fib with RVR, mod-severe PFO with R to L shunt, spontaneous intraperitoneal bleed, septic shock, renal failure and ultimately multi-organ failure. Family made decision to transition to comfort measures only. She died shortly after extubation.
76 2021-04-06 facial paralysis Pain in left side of Neck and Ear and both eyes ,Then on the second night the pain moved to the rig... Read more
Pain in left side of Neck and Ear and both eyes ,Then on the second night the pain moved to the right side of Neck and ear and both eyes,The third day I noticed that the lip is shiffted to the right
76 2021-04-07 weakness Total fatigue and lack of energy; pretty motionless, could take a shower & read but that was about ... Read more
Total fatigue and lack of energy; pretty motionless, could take a shower & read but that was about it; sleeplessness; headache; recurring chills; allover muscle & joint pains, nausea, appetite loss -- lost 6 lbs. in 6 days; blurred vision, dizziness. On the 5th day was able to eat cheese sandwich; only chicken noodle soup & crackers & tea & toast prior to that. Finally on the 8th day began to feel normal.
76 2021-04-07 feeling cold, feeling hot, hot flush She got the vaccine, when she came home she started feeling the fatigue that she felt after the 1st ... Read more
She got the vaccine, when she came home she started feeling the fatigue that she felt after the 1st vaccine. She then started feeling very cold, laid down and watched TV. She then had chills all night and did not sleep well due to that. When she got up on Tuesday the chills were gone but had a slight headache off and on throughout the day, her temp was 97.2. Throughout the day she would get warm spurts/hot flashes, as well as fatigue. She did sleep that night, and when she got up yesterday morning still had the hot flashes and it was 94.2, and took it twice due to it being so low. She was like that with fatigue and not able to sit up. She went to bed, took some Tylenol and rested. The heat feeling it started going away. Around dinner time she felt more like herself, the headache was gone and her temp was 97. She was doing pretty good, and the last thing she had was she felt on her cheeks and noticed a rash on her face, like a prickly heat type rash. Before she went to bed she put Neosporin on it, and when she got up this morning it was almost gone but still has a tiny few bumps. The arm itself did not hurt at all. Feels that it is a stressful situation as to where to get the vaccine and having to travel to get it as it's not available in locations closer to their homes. The people at the pharmacy were great, but had to travel and if it wasn't for her daughter she would probably not have her shot.
76 2021-04-11 hot flush Presented to emergency department with chest pain, report symptoms a few days prior to presentation.... Read more
Presented to emergency department with chest pain, report symptoms a few days prior to presentation. Reported mild shortness of breath, chills, and hot flashes. Was found to be COVID-19 positive upon admission to hospital floor. Symptoms are believed to not be related to COVID-19 infection and was not treated for infection.
76 2021-04-12 feeling cold, flushing is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no sid... Read more
is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no side effects from her first COVID-19 vaccine. After the 2nd one she had muscle aches, headache, freezing cold, and "weird", and felt really badly then at 9:30 PM, 32 hrs after the 2nd vaccine dose she felt the a-fib started. She had not been in a-fib in many years. Cardiology had already recommended eliquis but she was holding off. She had diltiazem from 2017 that she tried but with out relief. They rate controlled her but she remained in a-fib, started eliquis, and she went home. For 2.5 weeks she had headache and chest pain, other muscle pain, felt horrible, until she stopped the Eliquis. Since stopping the Eliquis, she still has occasional mild chest pain, and headache, and flushing. Her current chest pain is left chest, not radiating. The quality varies, stabbing pain in a very small location at times, may be associated with eating. She did have a stress test years ago and was "fine". She had a dental appointment planned that she had to cancel, she has moved it to May 4th.
76 2021-04-13 pain in extremity Patient noted that 2 days after vaccination that her left shoulder became very sore and achy. She wa... Read more
Patient noted that 2 days after vaccination that her left shoulder became very sore and achy. She was unable to left her shoulder. She denied redness or swelling at the site. Used tylenol. Did not contact MD. States her shoulder hurt for approx. 3 weeks post vaccination. Was massaging her arm to help relieve pain and it eventually felt better. Also shared that her left thumb also was sore and reddened post vaccination but unsure if it was related. Does not recall an injury.
76 2021-04-16 burning sensation It was very sore; Getting a reaction and it started to turn red; it keeps spreading on my arm it's f... Read more
It was very sore; Getting a reaction and it started to turn red; it keeps spreading on my arm it's from below where the shot was; Going around the arm and it's kind of like a burning itch; it is annoying; little redness on my arm; allergic to the preservatives in the vaccine; Going around the arm and it's kind of like a burning itch; it is annoying; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 17Feb2021 as single dose for covid-19 immunisation. Medical history included ongoing cholesterol. Concomitant medication included rosuvastatin taken for cholesterol, start and stop date were not reported. Historical vaccine included FLU for patient had a Flu Shot but it only got little red, little redness on my arm and first dose of BNT162B2 (Lot number: EN6200, Expiration date: Jun2021) via an unspecified route of administration on 27Jan2021 for Covid-19 immunization. Patient stated, "patient got the Pfizer second shot on Wednesday (Clarified as 17Feb2021) patient arm didn't start to bother me or it was very sore (Further clarification was unknown if consumer's arm was sore or not, hence captured as event) but then on Friday patient noticed patient was getting a reaction and it started to turn red so patient had an allergic reaction to it, except that it keeps spreading on patient arm it's from below where the shot was, it didn't hit the elbow yet but it is going around the arm and it's kind of like a burning itch it's not something terrible it's not something patient cannot deal with but patient was concerned about it and patient wondering if there is something patient can take or do because it is annoying on 19Feb2021" Patient believe because patient had a Flu Shot (Captured as provided) but it only got little red. patient think patient was allergic to the preservatives in the vaccine (COVID-19 Vaccine) because a friends of my works in a doctor's office and she was with me and she said I am probably allergic to, what you call the preservatives in the vaccine." Patient stated, "No it's been a while, it's been, you know it was just a little redness on my arm on 19Feb2021." Patient received a treatment that put some Ice on its last night and then patient took a Benadryl, you know generic Benadryl from a Walmart. The patient underwent lab tests and procedures which included Cholesterol and Urine: unknown results on an unspecified date in 2021. The outcome of the events was unknown. Information on Batch/Lot number has been requested
76 2021-04-19 feeling cold Feeling cold, headache,cough, extreme tiredness Took ASEA cell stimulating molecules, 1 Tylenol, sl... Read more
Feeling cold, headache,cough, extreme tiredness Took ASEA cell stimulating molecules, 1 Tylenol, slept 10 hours and was fine
76 2021-04-19 nerve pain About three days after getting vaccine, I began having pain in my shoulders and neck. For three wee... Read more
About three days after getting vaccine, I began having pain in my shoulders and neck. For three weeks I had sharp, nerve like pain on the top of my shoulder which kept me awake most of the night. I thought it would go away. The sharp pain went away after three weeks, but pain in shoulder and bilateral neck persists. I saw on 04/09/2021. She prescribed a muscle relaxant and physical therapy. The muscle relaxant didn?t help and I didn?t do the p.t. She offered to refer me to an orthopedist, which I declined.
76 2021-04-20 facial paralysis, mild one side paralysis Patient dreamt she was having a stroke around midnight (estimated) the night of her vaccine. Woke wi... Read more
Patient dreamt she was having a stroke around midnight (estimated) the night of her vaccine. Woke with LUE/LLE weakness and facial droop. Did not immediately report, but after persistent symptoms presented to ED 3/10 for evaluation. MRI showed early infarct right frontal lobe in setting of extensive chronic ischemic small vessel disease throughout the periventricular and subcortical white matter. MRA head/neck negative. EKG: NSR
76 2021-04-21 pain in extremity 03/17: Got 2nd dose of Pfizer vaccine 03/23: Pain started in chest and leg 03/24: Pain forced her to... Read more
03/17: Got 2nd dose of Pfizer vaccine 03/23: Pain started in chest and leg 03/24: Pain forced her to go to ER where it was discovered that she had a clot in her lungs and leg. Now on Xarelto
76 2021-04-23 pain in extremity, feeling cold feeling cold throughout the day; sore area on her arm; This is a spontaneous report from a contactab... Read more
feeling cold throughout the day; sore area on her arm; This is a spontaneous report from a contactable nurse (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982 and expiration date was not reported) intramuscularly on 02Feb2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled to receive the second dose on 23Feb2021. It was stated that she had heard rumors by word of mouth and blogs that the second shot is a real doozer. Some of the things she had heard were really disturbing and was hearing that a lot of elderly people had died from the second shot. On an unspecified date, patient was having a sore area on her arm and feeling cold throughout the day after receiving the first injection, and state that both of those side effects passed throughout the day. Patient asked how many people had died after receiving the second vaccine and probably doesn't have right up to the minute information about how many people were dying from this vaccine. Patient reported that she had friends that took the second dose and they all had chills, body aches, headache and fevers. Patient also asked If she don't take the second shot, or take it months later from now, and a new variant strain comes out, will she more susceptible to the new variant strain by not taking the second shot and being covered totally and stated Dr. (Name)came out and said if she don't take the second dose, she will be more susceptible to the variant strain attacking her and she could die from it. Patient wanted to know instead of taking her second vaccine next week, can she delay it and take it months from now and asked will the vaccine be effective. Patient wondered why there was no expiration date on her vaccine record card. She made the comment might be because it was so new, that's why there wasn't one. The outcome of the events was unknown.
76 2021-04-23 pain in extremity Arm was sore from vaccine; This is a spontaneous report from a contactable consumer or other non hcp... Read more
Arm was sore from vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Feb2021 as single dose for COVID-19 immunization. Patient was 76 years old at the time of vaccination. Patient medical his-tory and concomitant medications were not reported. On 05Feb2021 the patient experienced arm was sore from vaccine. Outcome of the event was unknown.
76 2021-04-23 tingling, speech disorder coughs it is like a bronchitis type thing; coughs it is like a bronchitis type thing; full of phlegm... Read more
coughs it is like a bronchitis type thing; coughs it is like a bronchitis type thing; full of phlegm; back started to hurt; tingling to the bottom of her feet; tired; severely sick; she couldn't walk or talk; she couldn't walk or talk; She shrunk; This is a spontaneous report from a contactable consumer (reported for herself). This 76-year-old female BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: unknown), via intramuscular route on left arm as a single dose on 06Feb2021 12:15pm, for covid-19 immunization. Medical history included minimal (borderline high blood pressure (since 6 years prior to this report). Concomitant medication included Lisinopril 10 mg once a day orally. On 06Feb2021 About 4 hours later after she got the shot, the patient experienced some tingling to the bottom of her feet with and without walking and felt like needles, then it went away some but not totally, and her back started to hurt. On 10Feb2021, she was coughing and full of phlegm. On an unknown date, since getting the first dose of the covid vaccine she had been severely sick, she could not walk or talk, felt really tired, and she shrunk (weight about 130 pounds). The patient did not have any history of previous immunization with the Pfizer vaccine. She was not administered any additional vaccines on Same Date of the Pfizer Suspect. The events did not require emergency room/ Physician office visit. She did not receive any prior Vaccinations within 4 weeks. There were no relevant tests performed. The patient recovered from the event of tingling on 07Feb2021. The outcome of the event of was event of phlegm was recovering. The outcome of the events of coughing, severely sick, she could not walk or talk, felt really tired, and she shrunk was not reported. She had not recovered from the event of back started to hurt and it had worsened. Information about Batch/Lot number has been requested.
76 2021-04-24 numbness This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8730) via an unspecified route of administration on 24Mar2021 at 10:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing pollen allergy from an unspecified date and ongoing ribs sore from an unspecified date. The patient stated that the pollen was bothering her and that she had been taking Zyrtec in the morning and at night. Medical history (including any illness at time of vaccination) was also reported as none. Family medical history relevant to the event was reported as "her son also had a seizure after the polio vaccine when he was 7 years old". Concomitant medications were not reported. It was reported that the patient denied any medications or medical conditions relevant to symptoms. There were no additional vaccines administered on the same date as the COVID-19 vaccine and there were no prior vaccinations received within 4 weeks of the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN202) via an unspecified route of administration on 24Feb2021 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. The patient previously received the polio vaccine on an unspecified date for immunization and experienced seizure and the patient previously received the flu shot on an unspecified date (6 years ago) for immunization and 8 hours after the vaccine was achy, sick, in bed for 9 days. Developed bronchitis and coughed so hard she cracked her ribs. Stated her ribs were still sore at times to this day. The patient stated that she would never get another flu shot and that her doctor agreed with her on that decision. On 25Mar2021 the patient experienced headaches, dizziness, dizziness comes and goes but it affects her vision, numb, head feels fuzzy/fuzziness is constant and eyes are crossing. The patient stated that she got her second dose of the vaccine on 24Mar2021. She reported that after her first shot she was fine. She stated that she started having headaches and dizziness the day after her second vaccine and this had lasted for 14 days. It has gone on now for several weeks and was not getting any better. She felt her symptoms went in different degrees at different times of the day. She might go one day without a headache. Today her headache was more like a numbness all around her head. She stated that her headaches come and go, sometimes start when her eyes pop open in the morning or at 10 AM. If she was going to have a headache that day, it usually started by 10 AM and was a full-blown headache. Stated her head always fely fuzzy and woozy and sometimes she felt like her eyes were crossing. She stated that she never got headaches; not since her early 20s. Dizziness continued to come and go, but it affected her vision and she was scared to drive and have a wreck. She reported that the symptoms were driving her bonkers. She also reported that she had to hold onto walls when she walked. The dizziness did not go away even when she laid down. She was dizzy when sitting on the sofa. Her head also felt fuzzy and numb, the fuzziness was constant. She reported that she felt disabled and felt like she was turning 100 instead of 77. She cannot lay in bed all the time and wanted to know how long these symptoms would last. The patient denied any labs, testing or treatment relevant to symptoms. She had not been to the doctor or to the emergency room in relation to these symptoms. She stated that she thought about it at times. She stated that she would have to call an ambulance to take her since she was scared to drive. Yesterday she thought she was not doing so bad and drove to the store. She stated that while in the store, her dizziness had her to where she could hardly pay for her items. Stated that it kind of felt like she was drunk, but she was not drunk. The patient stated that her experience with the polio vaccine made her almost not get the COVID-19 vaccine for fear it would bring on a similar situation. The clinical outcomes of the events headaches, dizziness, dizziness comes and goes but it affects her vision, numb, head feels fuzzy/fuzziness is constant and eyes are crossing were all not recovered/not resolved. No follow-up attempts are needed. No further information is expected.
76 2021-04-24 pain in extremity, weakness Injection site pain; Tiredness; Headache; Chills; Fever was 101.6; Injection site redness; Nausea; N... Read more
Injection site pain; Tiredness; Headache; Chills; Fever was 101.6; Injection site redness; Nausea; Not feeling well; Felt bad; Weakness; Soreness arm; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Feb2021 at single dose for COVID-19 immunisation. Medical history included Pulmonary hypertension and high blood pressure from an unknown date and unknown if ongoing. Patient previously took first dose of vaccine for Covid-19 immunisation. Concomitant medication not reported. When probed for the concern, consumer stated, "I was just calling to pass on my experience with the second vaccine. I ended up having all of the side effects that you had listed. I have injection site pain and redness and it still is as up today and I had the injection on Tuesday (23Feb2021). I had tiredness, headache, chills, fever and my fever was 101.6, injection site redness, nausea and basically not feeling well and I also had some weakness and I think that was because, I mean I felt so bad I was pretty much in bed and today is my first day up since Tuesday." The patient underwent lab tests and procedures on unspecified date which included Body temperature: 101.6. The outcome of the events Injection site redness, Soreness arm was reported as not recovered and outcome for other events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
76 2021-04-24 pain in extremity Rash; itching from the injection site; pain on right arm; swelling on the Right arm; This is a spont... Read more
Rash; itching from the injection site; pain on right arm; swelling on the Right arm; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2, Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 13:15 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Asthma, hypersensitivity from an unknown date and unknown if ongoing Verbatim: Allergy. On 22Feb2021, the patient experienced rash, itching from the injection site, pain on right arm, swelling on the right arm. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of rash. The outcome of the event rash was recovering, and rest event outcome was unknown. No follow-up attempts are possible. No further information is expected.
76 2021-04-25 numbness, tingling Tingling and numbness in left arm. Declined hospital by EMS.
76 2021-04-25 tremor She got her vaccine, started with a headache, severe and then it went to chills, then started with a... Read more
She got her vaccine, started with a headache, severe and then it went to chills, then started with a low grade fever of 99.1. She was cold, shaking, then was tired, joint and muscles aching, and not wanting to move, just wanting to sleep. No appetite. She took a baby aspirin, the headache subsided but returned when the aspirin wore off. She was out of it from Saturday to Sunday morning. The headache was so severe and she took some Tylenol. During the night she sweated so much that everything was drenched. She had to get up and change her clothes again as she was wet from the chills, and urinating a lot possibly due to the water intake. She feels much better than she did yesterday and Saturday but still having headaches, and not wanting the 2nd vaccine. She did have COVID in July of 2020 and hospitalized 3 times during that time-frame. She does not want to experience the same reaction. She has an APT with her PCP coming up in May. She was also diagnosed with the regular flu in January and feels that she has the same symptoms if not worse than what she had experienced in the past. She did have dizziness a lot and had to use her walker to steady herself first.
76 2021-04-26 inability to speak Unable to speak, (stroke like symptoms), was taken to ER and was treated for a stroke but was later... Read more
Unable to speak, (stroke like symptoms), was taken to ER and was treated for a stroke but was later determined to not have had a stroke. Was unable to function for two days. After two iv ingested antibiotics she started to talk and walk. There was never a diagnosis given for the 3 days spent in ER.
76 2021-04-27 weakness, coordination abnormal Her legs got weak; she lost coordination; anxiety was exacerbated by her terrible fatigue; depressio... Read more
Her legs got weak; she lost coordination; anxiety was exacerbated by her terrible fatigue; depression was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; She noticed that her blood pressure raised after receiving the first dose of the covid vaccine.; Total exhaustion/she is so tired; could not sleep; She experienced pain at the injection site./Her pain got worse and worse; left or right toe will get stuck; hysterical; she is stressed; did not have complete energy; She states that her illness is too much; This is a spontaneous report from a Pfizer sponsored program received from a contactable healthcare professional (patient). A 76-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscularly administered in the right deltoid on 30Mar2021 10:00 (Lot number: GR8732 or 6R8732 [as reported]; Expiration Date: 31Jul2021) as a single dose for covid-19 immunisation. Medical history included blood pressure/hypertension; had breast cancer twice with the last time was in 2010 to unknown date which was 23 years later than the first time she had it (1987). She had infiltrating ductal cancer, stage one, that was HER-2 positive. She states that this is the most malignant breast cancer. She had to have extensive chemotherapy and also took Herceptin every 3 weeks for a year. The overriding symptom from her cancer was extreme fatigue; has been in chronic fatigue syndrome and in bed for 7 years, she was getting over chemo and she can barely walk. She has trouble walking long distances; had a mastectomy from 2010 to an unknown date without lymph node dissection; had a central node dissection; took a wheelchair to the hospital whenever she received the first dose of the covid vaccine; ongoing anxiety, depression and nervousness which is not new to her. She has had this on and off for the past year; and antihistamine that raises her blood pressure dangerously, it does not matter which kind of antihistamine whether it is Benadryl or over the counter. The only antihistamine that does not raise her blood pressure was a children's allergy medication. She took half of a children's dose. It did not raise her blood pressure, but it did not stop her itching. Family history included her mother's sister and she are very sensitive to medications. She has the same type of problems. As her mother's sister has aged, her problems have gotten better. As caller gets older, her problems are getting worse. Concomitant medication included carvedilol taken for blood pressure on unknown therapy dates. The patient previously took dupilumab (DUPIXENT) for skin conditions that having itching which she had side effects (Lot number: 0LU23A; Expiration date: Feb2023). Dupixent is a medication used for skin conditions that having itching, not cirrhosis, she cannot remember the name of the skin condition. Her skin started itching around Jun2020 or Jul2020. She saw eight different dermatologists. She found a doctor who was an itch specialist. Dupixent is the only thing that is going to work for her because antihistamines raise her blood pressure dangerously; and one time her doctor made a mistake, he ordered her hydroxyzine 25mg PO (Per oral). The doctor did not look on her chart to see her allergy list. She cut the pill in half and took half a dose. By the time she realized what she took, she was having so much itching. She woke up and felt like her head was going to explode and her blood pressure was 220/112. She took three tablets of her antihypertensive medication. She taken carvedilol 3.125mg. She did not even bother going to the hospital because by the time they would have saw her, and treated her, she could have had a stroke. The hospital is slow to treat people. Because she is a nurse practitioner, she knew that 3 tablets would be the correct dose for how high (Apr2021) her blood pressure was. She also previously took Benadryl but that raises her blood pressure dangerously. The patient reported that she received her first dose of the covid vaccine on 30Mar2021 and she had many side effects. She reported that the most predominant symptom is total exhaustion. For the first seven days after receiving the first dose of the covid vaccine, she was in bed for seven days nonstop. She placed a large grocery shopping order. She was able to get up and use the bathroom and cook small meals. She had someone come in to help her with the dishes, and to clean up the house. She talked to her internist of 20 years, and he told her to take the vaccine. Within five minutes, she started getting side effects. She inquired if it was safe to take the second dose of the covid vaccine. She has been so fatigued that she has been in bed for a 3 weeks-time frame and then her Blood pressure went up, it was 200 something, like 223/103. She went to the ER, and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room, and because she waited so long, she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She added that the second week after receiving the first dose of the covid vaccine, she was able to get up every other day and go somewhere but the next day after she went somewhere, she was in bed all day and did not have complete energy (2021). She added that her refrigerator was going out, so someone drove her to department store 30 minutes away. She walked from the car, to the refrigerator section in department store, walked into the mall to get ice cream and then walked back to the car. By the time she got home, she immediately got back in her bed because she was so worn out. That was on Saturday. She was in bed all day yesterday. This morning, she feels better than yesterday. She thought about going to the store yesterday, but she knew she did not have the energy to go. Someone is coming later today to help her, and they will have to go to the store for her since she does not have any family nearby. She mentioned that the total exhaustion began on 31Mar2021. She took a wheelchair to the hospital whenever she received the first dose of the covid vaccine. She has trouble walking long distances. She called the hospital before she went, and the hospital did not have any wheelchairs she could use. The hospital cleared everything out of the way so they could fit the most patients as possible in the building. She had trouble walking the day that she received her first dose of the covid vaccine. Someone wheeled her in and out using her own wheelchair. She cannot go to the grocery store. Using a wheelchair is the only way she could have in and out. She could walk from her wheelchair into the examination room, and then after she went right back into her wheelchair. She is glad that she called because she does not know what she would have done without a wheelchair. It is hard for her to go on, sometimes she just feels like crying. Her trouble walking does not feel 100 percent, but it has gotten better. She is anxious, depressed and nervous also. Before her breast cancer, she had chronic fatigue. She could volunteer at a clinic for a few hours a week. She had radiation, and that caused exacerbation of her chronic fatigue. Her doctor told her that for some people, chemotherapy will make chronic fatigue better and that chemotherapy could help her chronic fatigue. Before she got chronic fatigue syndrome, she had a lot of energy. She used to work in an ICU that had 15 patients, with ambulatory patients on the outside. She worked six days a week then she transferred to a hospital where she took care of patients after they had open heart surgery. She used to be a very high energy person. Her exhaustion has gotten better, because she can get up every other day and leave the house. She cannot stop doing life. It is difficult for her that she cannot go to the grocery store. After seven days, she could go out every other day. Whenever she went to a certain company, she almost fell. Her legs got weak and she lost coordination on Tuesday (06Apr2021). Since then, it has happened a little bit here and there. It is almost like she is not sure when it will happen. In an instance, she can be working in the house, and her left or right toe will get stuck. This happens to her occasionally after chemotherapy. She noticed that her blood pressure raised after receiving the first dose of the covid vaccine (Apr2021) and she takes medication (small dose of carvedilol) for hypertension. She takes her blood pressure medication every other day. Out of the past four days, her blood pressure has been elevated twice (Apr2021). If her blood pressure is elevated more than normal, her doctor prescribed for her to take an extra dose. Her blood pressure has not been elevated dramatically. She did take an extra dose of carvedilol because her blood pressure was within the scope of her blood pressure expertise. She went to the ER and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room and because she waited so long she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She also stated that her blood pressure went up yesterday last night (18Apr2021), not right after getting the first dose. Last night at 6:00 PM, she took a nap and after she woke up took her blood pressure, she didn't feel anything in specific, she always takes her blood Pressure pill twice a day anyway. When she checked her pressure, it was 223/120 (Apr2021) and immediately took 2 Carvedilol 3.125mg and went to the ER, by the time she got there it was down significantly (Apr2021), but she is anxious and sat there and waited. They said they were going to do some blood work and an EKG but they left her there, so she decided to take a company home. Her Blood pressure has been up, she then went to sleep and after (Apr2021), it was 189/105, 183/105, and 165/95, she is a nervous wreck. She was ill for a long time, she had cancer twice, now she lives alone, she has been alone for all these weeks, her friends are here and there and come over. The Last 3 weeks she has been alone. She hired someone, but it was expensive. Now she feels hysterical (2021), after she saw her blood pressure, last night she was crying, and called the neighbor and they drove her right to the hospital then she was waiting in the ER for so long. She got her first shot on 30Mar2021 and she couldn't do anything in bed for 7 days, she is supposed to get the second shot tomorrow (20Apr2021) but doesn't want to be in bed again like that. She is anxious, depressed and nervous that began on 03Apr2021. During the week, she is distracted by the market. She has not been able to trade, because she does not trust her judgment right now. She did buy one this morning. Anxiety, depression and nervousness is not new to her which she has had this on and off for the past year. She has a lot going on. She needed to sell her two-story house and move to a one-story house that is easily assessable to healthcare and meals. She thinks this is disabling in face that she does not feel strong enough to make a decision. She cannot make a decision and she does not feel good enough too. Her anxiety, depression and nervousness was exacerbated by her terrible fatigue. She is experiencing awful symptoms. She went to the grocery store, and the stumbled and went into a company. She had to carry her milk and other items in slowly, and little by little. She thought this is awful, and she got into bed. She could not do anything. She mentioned that her illness is too much (2021). She was crying and she lives alone. The patient mentioned that the pain at the injection site began four hours after receiving the first dose of the covid vaccine. She received the vaccine at 10:00 AM then started getting really bad pain about 6:00 PM and then about 10:00PM or 11:00PM, it started to get unbearable. By 12:00AM (31Mar2021), the pain was so bad that she could not sleep because of the pain. She was in agony. She took took Tylenol and it did not touch her pain, but her pain got worse and worse, so she took three Tylenol tablets then they worked. She her friend and asked him to come over since she is afraid to take narcotics. She just laid there in bed and spent all night in agony. She tried a thing she put in the freezer and tried heat. She does not remember if either of those worked. The pain resolved about 2 days after. The patient declined safety report, saying that she is stressed and anxious (2021), she just wants to be transferred for her question. The reporter considered the events fatigue aggravated serious and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as medically significant. The outcome of the events fatigue aggravated recovering; as for the events blood pressure raised, 'anxiety, depression and nervousness was exacerbated by her terrible fatigue', lower extremities weakness of and coordination impaired were not recovered; while the event vaccination site pain was recovered on 01Apr2021 (reported as 2 days after). The outcome of the other events was unknown.; Sender's Comments: Based on the information provided, the events fatigue aggravated and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as serious (IME).Based on the plausible temporal association and product safety profile, the reported events are possibly related to the vaccine BNT162B2. administration. This case will be reassessed upon receipt of additional information.
76 2021-04-27 pain in extremity Blood clot in her lower abdominal area; had the worst pain through her side that ran down her left l... Read more
Blood clot in her lower abdominal area; had the worst pain through her side that ran down her left leg and to her ankle; had the worst pain through her side that ran down her left leg and to her ankle; nerves are all tangled up; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Arm Right on 17Mar2021 13:50 (at 76-years-old) as single dose for COVID-19 immunisation. The vaccine was administered at a hospital. It was not administered at a military facility. Medical history included hip replacement four years ago in 2017 (First right then 2 months later left) and knee replacement six years ago in 2015 (both 2 months apart). There were no concomitant medications. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6203), administered in Left Arm on 25Feb2021 (at 76-years-old) for COVID-19 immunisation and experienced bad headaches. The patient received the second dose of vaccine on 17Mar2021. On 29Mar2021, she was not hurting and went to brunch with friends. Afterwards (on the same date, 29Mar2021), she was sitting and got the worst pain through her side that ran down her left leg and to her ankle. She drove herself home but was in such misery. She went to the emergency room the next day, on 30Mar2021, wherein she had a CT (computerized tomography) scan that showed a blood clot in her lower abdominal area. She was taking pain medication every 6 hours, or she could hardly stand it. On 08Apr2021, she went back to the emergency room because she could hardly stand it. She was kept in observation status but was not admitted. She was scheduled to have another CT scan on 06May2021. She is not sure what they will do because the nerves are wrapped around it. She also mentioned that her doctor wants to do a biopsy. The pain was also running down to her ankle. She stated that she has had both of her hips replaced in the past. She added that her doctor will do an MRI (magnetic resonance imaging). He will put in a drain if it has not shrunk. The doctor can't do anything because the nerves are all tangled up (2021). As corrective treatment, the patient was taking pain medication for the blood clot and pain through her side that ran down her left leg and to her ankle. Outcome of nerves are all tangled up was unknown, while outcome of the other events was not recovered.
76 2021-04-27 tremor sore muscles, especially lower back; some shakes and/or chills; some shakes and/or chills; sore musc... Read more
sore muscles, especially lower back; some shakes and/or chills; some shakes and/or chills; sore muscles, especially lower back; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in in Arm left on 09Feb2021 14:30 (Batch was not reported /Lot number 2192050) (at the age of 76-years-old) as single dose for covid-19 immunisation. Medical history included breast cancer from an unspecified date in 2016, penicillin allergy and sulphate allergy. Concomitant medications included multi vitamin (unspecified), acetylsalicylic acid (ASPIRINE) and anastrozole. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date, administered in arm left (Batch/Lot number was not reported) for covid-19 immunisation. On 10Feb2021 14:00, the patient experienced some shakes and/or chills, sore muscles, especially lower back. No treatment was given for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
76 2021-04-28 weakness On April 1, 2021 I woke up with pain in my left hip. As the day went on it got much worse and the na... Read more
On April 1, 2021 I woke up with pain in my left hip. As the day went on it got much worse and the nausea started to the point where my husband had to take me to the ER . They gave me some pain medicine, nausea medicine and did a cat scan of my abdomen. Nothing was found and I was sent home. April 4th the pain got so severe and the dry heaving to the point where blood came out. Again I went into the ER this time by ambulance because I was so weak at that point where I couldn?t walk. Again they gave me pain medicine and nausea medicine along with prednisone. It took about a week to recuperate and now I have severe tinnitus.
76 2021-04-30 pain in extremity Arm hurts a little bit, after first vaccine; Tiredness, after first vaccine; Chills; Back hurts a li... Read more
Arm hurts a little bit, after first vaccine; Tiredness, after first vaccine; Chills; Back hurts a little; This is the spontaneous report received from a contactable consumer(patient). A 76-years-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history included usually constipated, her doctor put her on magnesium and docusate sodium (COLACE). Concomitant drugs included magnesium and docusate sodium, both for constipated. She experienced tiredness, arm hurts a little bit, chills, back hurts a little. The clinical course was reported as follows: the tiredness did not start until a couple days later and eventually went away. The arm hurting did not happen the first few days, it was not as bad the second day. She added that she could not complain about it. She did not have a fever, her temperature was 97.5. Her back hurts a little, but it hurts a lot anyways. She did not like to sit a lot. She liked to be active because it helps, but it was too gloomy to do anything on 12Apr2021. The seriousness of the events was unspecified. Outcome of tiredness was resolved. Outcome of the other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
76 2021-05-02 facial paralysis Left side of face paralysis- eyebrow, eyelid and mouth, pain in left ear. Symptoms left after 2 we... Read more
Left side of face paralysis- eyebrow, eyelid and mouth, pain in left ear. Symptoms left after 2 weeks.
76 2021-05-02 feeling cold, tremor, weakness, flushing 03/09: presents to the ED with palpitations that began 90 minutes prior to arrival. The patient has... Read more
03/09: presents to the ED with palpitations that began 90 minutes prior to arrival. The patient has a history of paroxysmal atrial fibrillation but has not had an event for many years. She had her second Covid vaccination yesterday and did have flulike symptoms including headache, myalgias, and shakiness through the last night. She wonders if this triggered her symptoms. No chest pain, dyspnea, or lightheadedness. 23: 18. Cardizem 17.5 mg IV. 03/10 still in ER 00: 17. The patient is discussed with hospitalist. would not recommend admitting the patient given her stability. The patient's atrial fibrillation responded very well to the IV Cardizem. Her atrial fibrillation is now in the 80s. She is asymptomatic. CHA2DS2-VASc score of 2. 00: 18. Cardizem 30 mg p.o. The patient is quite concerned about stroke. Her mother died of CVA. We will start anticoagulation today pending cardiology follow-up. Eliquis 5 mg po. Recommended follow up with cardiology 03/16 visit with cardiology Paroxysmal atrial fibrillation Established Recently symptomatic with RVR after Covid vaccination Rhythm controlled with flecainide 100 mg twice daily Rate controlled with diltiazem 120 mg daily ? CHA2DS2-VASc Risk Factors/Score: AGE(>=75), Female Gender and 3 points: "moderate-high" risk - Stroke risk as 3.2% per year and 4.6% risk of stroke/TIA/systemic embolism. o HAS-BLED Risk Factors/Score: Age > 65 years and 1 Points - "Low Risk" - 3.4% annual risk of major bleeding in one validation study and 1.02 bleeds per 100 patient-years in another validation study. Continue Eliquis 5 mg twice daily for embolic prophylaxis (creatinine 0.76 on 3/9/2021) 04/02 appt with PCP for ER follow up Patient is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no side effects from her first COVID-19 vaccine. After the 2nd one she had muscle aches, headache, freezing cold, and "weird", and felt really badly then at 9:30 PM, 32 hrs after the 2nd vaccine dose she felt the a-fib started. She had not been in a-fib in many years. Cardiology had already recommended eliquis but she was holding off. She had diltiazem from 2017 that she tried but with out relief. They rate controlled her but she remained in a-fib, started eliquis, and she went home. For 2.5 weeks she had headache and chest pain, other muscle pain, felt horrible, until she stopped the Eliquis. Since stopping the Eliquis, she still has occasional mild chest pain, and headache, and flushing. Her current chest pain is left chest, not radiating. The quality varies, stabbing pain in a very small location at times, may be associated with eating. 04/20 ER visit: Patient is a 76 y.o. female who presents with palpitations that started this evening, sudden onset, has a history of paroxysmal atrial fibrillation, and is maintained on 100 g of flecainide twice daily and diltiazem daily. She also has short acting diltiazem 60 mg tablets to take for episodes of breakthrough arrhythmia. She took a 60 mg short acting diltiazem prior to arrival She endorses some chest pressure with this though not severe, denies any dyspnea diaphoresis or nausea Not anticoagulated 04/29 Follow up with PCP For years she has been well controlled on low dose methimazole. Recently she has had 2 bouts of a-fib, when trying eliquis prescription and again following her 2nd COVID-19 vaccine. Upon recheck her TSH remains suppressed and FT4 elevated. Increasing from 5 to 10 mg methimazole now. Left side of thyroid is palpably thickened with no nodules noted. Recommended Ultrasound. Explained that if nodules are seen, a follow up image may be indicated to assess nodule activity. Not in a-fib today. C/o general malaise, shakiness, chest tightness, & flushing. Graves since 2006 She is feeling out of sorts, shaky, flushing, chest tightness, recurring headache. She has to stop and rest when trying to do activities as she will feel weak. Not sleeping well. Systolic BP labile, from 105, to 155, to 135.
76 2021-05-04 tingling, feeling hot she has a little bit of skin that is very dry; Pain under breastbone; Welts; lumps in her skin under... Read more
she has a little bit of skin that is very dry; Pain under breastbone; Welts; lumps in her skin underneath; Swelling: lips, face swollen, arms, hands, fingers, left foot, left kneecap left thigh, feet swelled up like a balloon; Fingertips felt tingley; rash on her palm, a red circle; hand was hot and itchy; hand was hot and itchy; Tired and exhausted; toes feel puffy; urinary tract infection; not sleeping; Rash, painful; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Feb2021 (Lot number: EL9262; Expiration date: 31May2021) on the left arm at 0.3 mL, single for COVID-19 immunization. Medical history included AFib from 2009 and ongoing; allergies to antibiotics and Penicillin; shellfish allergy. No family medical history. Concomitant medications included nitrofurantoin (monohydrate/macrocrystals; Manufacturer: Alvogen Inc) from 17Mar2021 to 24Mar2021 for urinary tract infection; prednisolone from 10Apr2021 to 10Apr2021 for rash; chlorphenamine maleate (ANTIHISTAMIN) from 12Apr2021 for rash; and taking unspecified medications for a long time. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) on the left shoulder at 0.3ml single for COVID-19 immunization. Patient previously also had something else 10 years ago that didn't work, it was not a vaccination; took doxycycline hydrochloride (DOXYCILLIN) and amoxicillin that both experienced allergies. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). Stated that she had a urinary tract infection and was put on antibiotics for 7 days. Two days after starting the medication, she came down with a rash. The patient husband, who was a family physician had never seen a rash like that in his 40 years of practice. In the newspaper, there was a woman who got the vaccination, but not sure if it was Pfizer, and had a rash; the article had a picture of the rash the woman had, after the vaccine. Patient stated that her rash looked worse than the woman in the newspaper. The rash happened after the second vaccine, several weeks later, but after the antibiotics. Patient was allergic to a lot of antibiotics. She stated she may have this problem, the rash because she was allergic to a lot of antibiotics. When she got the rash, she went to the Urgent Care and was given a Prednisone shot and Prednisone pills. She got some relief taking the Prednisone. Patient weight as about 5' 4", she gained 8 pounds over the year while being stuck in her house. Patient stated she hasn't seen healthcare provider in a while, but she called him and he gave her the antibiotic prescription. Patient experienced the rash was painful on 17Mar2021 and she could feel when another one would start happening. Patient put ice on it to sop the pain and moved the ice packs around as it was reactive to pressure. Stated if there was anything tight, like underwear, or sitting on the couch, she would get welts and lumps, initially mentioned the top of her head. Reclarified itchy in later part of report. Patient got a prescription for her medication on 17Mar2021 and took it for 7 days, and then the rash happened a couple of days after she stopped the medication. As she had a little bit of skin that was very dry and she can see a line where the rash was. The rash pretty much gone, but not 100 per cent gone. Stated she went to the Urgent Care walk in, when she noticed the rash. Patient had two Covid tests, one was a blood test and one was a nose swab; reported both as negative. Stated she should have gone to the emergency room, but the doctor, in the Urgent are gave her a Prednisone shot. The only reason she didn't go because of the Covid, pandemic, so she went to the Urgent Care. The last medication that she took for the rash was an antihistamine on 12Apr2021, and last Prednisone pill was 10Apr2021; both pills were effective in treating the rash. Patient had a Zoom call with an allergist, and the doctor saw the rash with the help of a flashlight and altered the Prednisone dose. Patient had pain under breastbone that it was really bad and the day before she went, to the Urgent Care on the 28th or 29Mar2021, may in the early afternoon. Stated it was going on the whole time, intermittently, not constant in the last few weeks. She didn't know what was causing it as she had blood work to rule out gallbladder issues and that was not back to rule out a Shellfish allergy. Patient had welts and it all blends in from when she first noticed the rash a couple of days before she went to the Urgent Care. Answered as they were faded out, it was severe, then acute, then extreme for a week or more, and improved with steroids and then faded. Patient had lumps and it started two days before she went to the Urgent Care. Stated when she was sitting on the couch, reclarified, the cords of the pillow put pressure on the areas and it hurt and felt like welts. When she pushed on her skin, here were lumps in her skin underneath, and they hurt and were hot. Described the areas of the lump as buttocks, top of head, legs, arms, groin, underwear line, ear, ear lobe and face. Patient had swelling of lips, and they looked like she had Botox. Also reported additional swelling of arms, hands, fingers, arm from the wrist up to elbow, left foot, left kneecap, left thigh, and her feet swelled up like a balloon. It was better now. Patient had fingertips felt tingley. The palm of hand that patient got rashes in response to pressure and was trying to open a bottle. When she did she got a rash on her palm, a red circle and her hand was hot and itchy. Started as two days before she went to the Urgent Care. Stated she was tired and exhausted from not sleeping and the redness faded away and then it went away a couple of days ago with the help of the steroids. Patient had toes, feel puffy that described as the feeling when she goes to the dentist after she gets Novocain, the feeling. Patient had tired and exhausted. Stated she was tired the first few days until the rash peaked, as she was up all night for two nights icing the rash. Stated she was better but was not doing too much and didn't get out of the house, only when she had to. Lab data included on unspecified dates the blood work for urinary tract infection was negative; negative results for two Covid tests, one was a blood test and one was a nose swab; blood work to rule out gallbladder issues and that was not back to rule out a shellfish allergy. No events required a visit to emergency room or physician office, but patient went to Urgent Care and had a Telehealth appointment. The outcome of events "Rash; Welts; Swelling" was recovering, while of the other events was unknown. No follow-up attempts are needed. No further information is expected.
76 2021-05-06 weakness Patient completed 2-dose Pfizer series on 1/31/21 and passed away on 2/13/21. Pt presented to ER on... Read more
Patient completed 2-dose Pfizer series on 1/31/21 and passed away on 2/13/21. Pt presented to ER on 2/11/21 with SOB, weakness, diffuse abdominal pain and diarrhea that started that day. Pt tested positive for COVID and was transferred out to a higher level of care. 1st dose: 1/5/21, 2nd dose: 1/31/21
76 2021-05-07 weakness, tremor Butterflies in the chest that went to quivering; quivering; A-Fib/Arterial fibrillation with rapid v... Read more
Butterflies in the chest that went to quivering; quivering; A-Fib/Arterial fibrillation with rapid ventricular response; Arterial fibrillation with rapid ventricular response; cannot rule out anterior infarct and abnormal EKG; cannot rule out anterior infarct and abnormal EKG; trouble breathing; Her heart rate is screwed up; she feels so weak; irregular heart beat; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Mar2021 (lot number: EP7534) as SINGLE DOSE for COVID-19 immunization. Medical history included asthma, chronic obstructive pulmonary disease (COPD), irritable bowel syndrome described as a condition where you're in the bathroom a lot, fibromyalgia, little depression, heartburn, upset stomach, heart fluttering issues, congestion spray (nasal congestion), and had part of a lung taken out. Family medical history included heart issues (dad and uncle). Concomitant medications included salbutamol (VENTOLINE [SALBUTAMOL]) for asthma; venlafaxine hydrochloride (EFFEXOR) for little depression; pantoprazole for heartburn and upset stomach; fluticasone propionate (lot number: AA47468, expiration date: Aug2020) for congestion spray (nasal congestion); fluticasone propionate, salmeterol xinafoate (ADVAIR) for heart fluttering issues. The patient previously took SHINGRIX (also reported as shingles vaccine, for clarification) for immunization and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) on 25Feb2021 (age: 76 years) in the left shoulder for COVID-19 immunization. On 18Mar2021, right after taking the vaccine, patient started to experience quivering inside. Initially it felt like butterflies in the chest and then to quivering, it was then quivering the whole week. She knew she was going in for a test , an endoscopy, where they go down the throat. So she waited, the quivering did not go away for a whole week. It lasted until Friday before her endoscopy. When they found out, they sent her to ER at the hospital. They did not do the endoscopy. They said they might have to shock her heart or something. They wanted her to see the cardiologist right away. From the ER, she had 2 IVs, 1 in each arm. They were also taking blood every 4 hours (unknown results). The provided diagnosis was arterial fibrillation with rapid ventricular response and cannot rule out anterior infarct and abnormal EKG (Mar2021). The events cannot rule out anterior infarct and abnormal EKG, butterflies in the chest that went to quivering, A-Fib/Arterial fibrillation with rapid ventricular response resulted in emergency room visit and physician office visit and let to hospitalization. The patient was hospitalized from 2021 to an unknown date (also reported for 2 days, for clarification). It also gave her A-Fib, trouble breathing and now her heart rate is screwed up (Mar2021). On an unspecified date in 2021, she feels so weak and has irregular heartbeat. Therapeutic measures were taken as a result of the events which included Eliquis, Atorvastatin, Diltiazem, and other unspecified medications. The outcome of cannot rule out anterior infarct and abnormal EKG, butterflies in the chest that went to quivering, arterial fibrillation with rapid ventricular response, she feels so weak was not recovered; while the other events was unknown.
76 2021-05-07 pain in extremity left arm pain severe lasted over 19 days
76 2021-05-10 bell's palsy Bell's palsy
76 2021-05-10 pain in extremity arm was hurting; This is a spontaneous report from a contactable consumer via Medical information te... Read more
arm was hurting; This is a spontaneous report from a contactable consumer via Medical information team. A 76-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number and expiration date: Not reported) via an unspecified route of administration as a single dose for COVID-19 immunization on an unknown date. The patient past medical history included Alzheimer's. Concomitant medications were not reported. The patient reported that on an unknown date, she woke up in morning and her arm was hurting, so she felt her arm and the band aid felt wet. She wants to know if this could be fluid from the vaccine that leaked out. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
76 2021-05-10 pain in extremity Mild sore arm; Chills; This is a spontaneous report from a contactable consumer (patient) via Pfizer... Read more
Mild sore arm; Chills; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number EL9266, Batch number- DDM#32), intramuscular, in left arm on 23Feb2021 (at the age of 76-years-old) at a single dose for COVID-19 immunization. Medical history included covid-19 in Nov2020 (reported as also had the virus) with no taste or smell for 4 months and was very tired for 2 weeks and Stage 3 kidney disease from Feb2019 and ongoing. There were no concomitant medications. The patient was vaccinated at Pharmacy/drug store. No other vaccine was given in four weeks. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EN5318, Batch number- DDM#32), intramuscular, in left shoulder on 02Feb2021 at 5:00 PM at a single dose for COVID-19 immunization after which the patent experienced mild sore arm and chills. The patient experienced mild sore arm and chills on an unspecified date. The events lasted for about 4 hours. The outcome of the events was recovered. Information about lot/ batch number has been requested. Follow-up (23Apr2021): New information received from the same contactable consumer (patient) included: Patient medical history and details, Product batch number and lot number, Outcome and duration of the events. Follow-up attempts are completed. No further information is expected.
76 2021-05-11 tingling Tingling on right side of tongue and cheek.
76 2021-05-12 tenderness Right knee pain; tenderness; swelling; Pain at injection site; This is a spontaneous report from a c... Read more
Right knee pain; tenderness; swelling; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), on 26Jan2021 at 12:00 (at the age of 76-years-old) at 1st dose, single administered in left arm for COVID-19 immunisation. Medical history included allergies. The patient was not pregnant. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications included calcium, tocopherol (MEMORALL), cetirizine, KETO, unspecified (all reported as other medications in two weeks). The patient previously took ampicillin and experienced allergies. No other vaccine received in four weeks. The patient experienced right knee pain, tenderness, swelling, continued. Pain at injection site lasting 24 hours. The events occurred on 30Jan2021 at 8:00. No treatment was received for the events. The patient had recovered from pain at injection site on 31Jan2021 at 08:00, had not recovered from the other events.
76 2021-05-13 pain in extremity left arm was inflamed and in pain and she was unable to lift it; woke up with pain in my left arm fr... Read more
left arm was inflamed and in pain and she was unable to lift it; woke up with pain in my left arm from my shoulder to my wrist; her left arm was inflamed; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: unknown), on unspecified route of administration on unspecified date at single dose for COVID-19 immunisation. Medical history was not reported. concomitant medication included Apixban (ELIQUIS) from an unknown date. The patient had taken vaccine in right arm, but she did not have any discomfort in that arm, whereas At 3:00am her left arm was inflamed and in pain and she was unable to lift it, she had to use her right arm to move her left arm. she had taken a blood thinner right before she got her vaccination. The outcome of events was unknown. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. Information on the Batch/Lot number has been requested.
76 2021-05-17 numbness After vaccine on Wednesday three fingers on my right hand went numb and my mouth felt like I had a s... Read more
After vaccine on Wednesday three fingers on my right hand went numb and my mouth felt like I had a shot of Novocain, then my tongue had a little tingling. I texted my doctor and he said to go to the ER and they checked me out did EKG, blood work, CAT scan, covid test that was negative and I was admitted. I got an MRI and did other urine test, I was being checked every hour. I was given Plavix and other meds and was told that I had a stroke/TIA.
76 2021-05-17 pain in extremity, feeling cold Dizzy,Fever, Disoriented, (expected: arm soreness, heat, swelling administered frozen pea bag) ras... Read more
Dizzy,Fever, Disoriented, (expected: arm soreness, heat, swelling administered frozen pea bag) rash on forearms,, not hives, passed out for 9 hours I thought I would just relax with my frozen peas and watch tv. 9 hours later, I was slumped on the couch, tv had not been turned on , I was fully dressed including shoes, no blanket or pillow, very cold all the lights that I had turned on were still on and it was 5:10 in the am I had not brushed my teeth or taken evening medication. I had warmed left overs in the oven thinking I might just be hungry. Oven was off but oven door was open food was uneaten except for a couple of bites. I live alone. I still work and manage everything on my own.
76 2021-05-17 pain in extremity Soreness under her arm unsure if muscle or lymph nodes; Pain under the arm, under the injection site... Read more
Soreness under her arm unsure if muscle or lymph nodes; Pain under the arm, under the injection site in which it was a soreness; Aching in arm; Achy; This is a spontaneous report from a contactable consumer. A 76-year-old female consumer (patient) reported that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318; Expiration Date: May2021) via an unspecified route of administration, administered in right arm on 04Feb2021 at 10:30 as first dose,single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Prior Vaccinations within 4 weeks. On 04Feb2021, the patient experienced after is that she felt a little achy and 04Feb2021 at 8:00 pm that evening her arm was aching, patient took an Ibuprofen and had no problem afterward, On 05Feb2021, the day after patient mentioned had pain under the arm, under the injection site in which it was a soreness which had no lump. She cannot discern whether it was a lymph node or muscle, but is leaning more into it being a muscle because patient could feel a pulling sensation when patient raises her arm at the shoulder. Patient was asking if these are common side effects and for how long do these usually last. On 06Feb2021 soreness under her arm, unsure if muscle or lymph nodes. The outcome of the events achy, pain under the arm, under the injection site in which it was a soreness were unknown, soreness under her arm was recovering and aching in arm was recovered on 04Feb2021. Follow-up attempts are completed. No further information is expected.
76 2021-05-19 pain in extremity she is a little tired; slight headache; arm hurt; she felt lousy; fever/she was running at 99.5 low ... Read more
she is a little tired; slight headache; arm hurt; she felt lousy; fever/she was running at 99.5 low grade fever; didn't feel well; She had chills; didn't sleep well; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Deltoid Right on 26Jan2021 15:00 (at the age of 76-years-old) (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient was not Vaccine Administered at Facility. The patient had no medical history (including any illness at time of vaccination). The patient had no family medical history relevant to AE(s). There were no concomitant medications. Historical vaccination included flu vaccine for the indication of flu vaccination which gave a reaction of sore arm. On 26JAN2021 patient experienced fever/she was running at 99.5 low grade fever, didn't feel well, she had chills, didn't sleep well, arm hurt and she felt lousy. The patient underwent lab tests and procedures which included body temperature: 99.5 on 26Jan2021 low grade fever; Her normal temperature is 96-97.0. On 27Jan2021, the patient had slight headache. On 28Jan2021, body temperature was 98.1 and she is a little tired, but her fever was 98.1. Therapeutic measures were taken as a result of fever/she was running at 99.5 low grade fever, didn't feel well, she had chills, didn't sleep well, slight headache, she is a little tired, arm hurt, she felt lousy. The patient got the first dose yesterday and had some reaction. She got a fever, her arm hurt and she felt lousy. She also mentioned that she took Tylenol yesterday. She and her husband got the vaccine on Tuesday 26Jan2021. Her husband was fine except for the sore arm but she didn't feel so well. Her normal temperature is 96-97.0 but she was running at 99.5 low grade fever and didn't feel well. She had chills and didn't sleep well. Last night she had a slight headache, chills, and didn't sleep well but today is much better. She has had no other symptom but was taking Tylenol. When speaking with her sister, she was told by her that she read Tylenol could effect the efficacy of the vaccine. She wants to know does it effect the efficacy, also her husband and her had a martini to celebrate getting the vaccine. Is that ok. The night of the 26Jan2021 she had chills that left her she was hot then cold. On 27Jan2021, later in the evening, she had a slight headache and then it went away later on that evening. Treatment: She could not gotten through the day without the Tylenol. Today, she is a little tired but her fever was 98.1 when she last took her temperature. She is much better today. The only way to describe yesterday is that she felt really lucky. The patient had no prior vaccinations (within 4 weeks). No AE(s) require a visit to Emergency Room. The patient had no relevant tests. The patient is healthy. The seriousness of the events was reported as non-serious. Outcome of the events fever/she was running at 99.5 low grade fever, She had chills, didn't sleep well, slight headache was reported as recovered on 28Jan2021, didn't feel well, she felt lousy and arm hurt was reported as unknown, she is a little tired was reported as not recovered. No investigation assessment needed. Follow-up attempts are completed. No further information is expected.
76 2021-05-21 weakness Pt recivied her 2nd covid 19 vaccine on 3/26. Patient is a 76-year-old female with a past medical hi... Read more
Pt recivied her 2nd covid 19 vaccine on 3/26. Patient is a 76-year-old female with a past medical history significant for hypertension, depression, hypothyroidism 2nd covid 19 vaccine on 3/26 who presented on 5/18 to the ER with complaints of lightheadedness and nausea that occurred over the weekend and was diagnosed with new onset rapid atrial fibrillation. She denied chest pain or shortness of breath but noticed intermittent bouts of palpitations. She went to see her PCP who referred her to the emergency room. EKG and telemetry in the emergency room were significant for new onset rapid atrial fib. She was given diltiazem and admitted to the hospitalist service. CT of the chest was negative for pulmonary emboli or focal consolidation. She had no electrolyte derangements she has no history of sleep apnea and no history of obesity. Her troponin and delta were unremarkable. She was subsequently admitted to the hospitalist service. She was treated with metoprolol and amiodarone along with Eliquis. She was seen by her cardiologist. Her recent echocardiogram was normal. Her TSH was actually elevated at 11.0 so her levothyroxine dose was increased to 175 mcg daily with a TSH in 6 weeks. At this time patient's rate is much better controlled but she remains in atrial fib. She will be following up with her cardiologist closely post discharge. She is also complaining of persistent R shoulder pain and weakness since her vaccine. Her shoulder x ray showed arthritic changes. She also c/o the worst headache of her life that lasted a week starting on May 4th. CT head was neg.
76 2021-05-24 pain in extremity She bled a little bit; A 'black and blue mark on the arm (as big as a tangerine, and is still there)... Read more
She bled a little bit; A 'black and blue mark on the arm (as big as a tangerine, and is still there)'; When she vaccination provider put the needle in, it really hurt/soreness; Her arm ached; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer reported for herself that . A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Right on 24Jan2021 13:00 as 1st dose, single for covid-19 immunisation. Medical history included for her belly. Concomitant medications included fish oil (OMEGA XL) (Has been taking for years) ongoing and glycopyrrolate [glycopyrronium bromide] taken for her belly, (Once a day) ongoing. On 24Jan2021 the patient experienced Black and Blue mark on arm, when she vaccination provider put the needle in, it really hurt/soreness and her arm ached. On an unknown date the patient experienced she bled a little bit. The patient stated that She got the vaccine on as confirmed Sunday 24Jan2021 and later that day her arm ached. She has heard a lot of people had ache, arm ache after getting the vaccine, but no specific patient details provided.She looked at her arm and she had a black and blue mark as big as a tangerine. She is not too happy that happened. She has to get the second dose of the vaccine 14Feb2021. She is not sure if she wants to get the second one. If this occurred with the first one. She also hurt with getting the vaccine. She is not sure where the needle was placed when getting the vaccine, but it hurt, and she bled a little bit. The nurse had to place a Band-Aid on it. Her arm is still black and blue. She noticed the black and blue mark on the same date she got the vaccine. It was later that day in the evening. She does not know the exact time. The black and blue mark is on her right arm. She noticed her arm ache shortly after she got the shot. It was a few hours after getting the vaccine, but she does not know what time. She stated this seems to be a complaint of a lot of other people, but no other specific patient details provided. It is her right arm that aches. She stated she is wondering if she needs to be concerned about these events. Should she be concerned about what her arm looks like. She is still having soreness. Therapeutic measures were taken as a result of a 'black and blue mark on the arm. The outcome for the events black and blue mark on the arm (as big as a tangerine, and is still there) and her arm ached was recovering. The outcome for the event when she vaccination provider put the needle in, it really hurt/soreness was not recovered. The outcome for the event she bled a little bit was unknown. Follow-up attempts are completed. No further information is expected.
76 2021-05-25 pain in extremity March 15th right upper thigh pain, sore to the touch. Around April 1st had to buy a cane to help wit... Read more
March 15th right upper thigh pain, sore to the touch. Around April 1st had to buy a cane to help with walking
76 2021-05-26 weakness not wanting to eat; headache; chills; cold; tired/very tired; just not feeling good/felt really bad/... Read more
not wanting to eat; headache; chills; cold; tired/very tired; just not feeling good/felt really bad/feeling so bad; weak/weakness; miserable; nausea/nauseous; This is a spontaneous report from a contactable nurse. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration (administered in arm Left) on 29Jan2021 at 11:30 AM (at the time of 76-year-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that her first dose of Pfizer vaccine on 29Jan2021. first dose of the vaccine by injection. Stated having side effects yesterday. Today patient has headache, chills, tired, just not feeling good, weak and miserable. Then all of the sudden yesterday she felt really bad. She was very tired with cold, chills, nausea and weakness. she received the first dose of the Pfizer COVID 19 vaccine on 29Jan2021 at 11:30 AM in the left arm. She was not sure of the time because she was feeling so bad and adds she has not gotten up out of the chair today. Then on 2Feb2021 in the afternoon, she started to felt really bad. Mentions that she thought she was nauseous because she was so nervous about getting the vaccine. Adds it wasn't really just like nausea but more like not wanting to eat. She stopped having chills last night. She was scheduled to get the second dose of the vaccine 19Feb2021. Patient mentioned she was shrinking due to natural aging. The outcome of chills was recovered on 02Feb2021 for tired/very tired and malaise (PT) was not recovered for weak/weakness and nausea (PT) was recovering while for other events was unknown. The reported events felt really bad, tired, nausea and weak were considered as related to suspect product. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
76 2021-05-28 weakness, pain in extremity weak; does not feel well; Stomach is upset 24/7; TSH is off; skin so itchy; dry heaves; nauseated/Na... Read more
weak; does not feel well; Stomach is upset 24/7; TSH is off; skin so itchy; dry heaves; nauseated/Nausea; sore arm; I don't like the way I'm feeling; This is a spontaneous report from a contactable consumer (the patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0773) via an unspecified route of administration in left upper arm on 04May2021 11:00 at age of 76-year-old at single dose for COVID-19 immunisation. Doctor wanted her to get it. Caller said that her doctor told her she wouldn't make it if she got COVID. Her heart couldn't pump very well and was very weak. Other medical history included a lot of allergies (They made her sit in a recliner for 30 minutes) and thyroid disorder. No further details provided by the caller regarding her thyroid condition. Caller did not think there were any other medical conditions that she had that would be relevant as she was pretty darn healthy. Family medical history relevant to AE: Not that she knows of. Daughter had the shot and was sick for 2 days. She had the Pfizer. No vaccine administered on same date of the Pfizer suspect. No history of all previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid from an unspecified start date for 20 years and ongoing. Got the shot 04May2021. Dry heaves on 04May2021: Didn't really throw up, but she had them all day. Still has them but not as bad. Nausea/ nauseated on 04May2021: It was actually kind of steady. Caller was able to eat and drink, not that she wanted to. She did not know what to do with herself. She was eating and drinking. She took TUMS [CALCIUM CARBONATE] and always had a cast iron stomach. Skin is so itchy on 04May2021: Skin started itching right away, that evening that she got the shot. She even used a back scratcher. It was all over and still felt the same. Treatment: Had taken diphenhydramine hydrochloride (BENADRYL) maybe once or twice and when she went to bed. She didn't take it steady. She did not take the TUMS steady either. Yesterday, she felt better, and currently felt worse again. Had a little more energy and was feeling good. Sore arm on 04May2021: Was sore right away, after the shot. It was still sore but it was better. It was not red or anything. Treatment: Took 1/4 of a paracetamol (TYLENOL), 325mg, so it was 12 or something. Weak on an unspecified date and did not feel well on an unspecified date. Her blood pressure was good and she has no fever. She also stated her stomach was upset 24/7. She didn't like the way she was feeling after the first dose (May2021). She just wish this would go away. She didn't feel good. 10 days was a long time to have a reaction. Tests: Recently had blood work and everything was normal. Even her thyroid stimulating hormone (TSH) which she got tested for every month is fine. It was off but currently was regular. The event did not require a visit to emergency room or physician office. Her next shot was on 25May2021 and was scared to get it. The patient asked what would happen if she did get the second dose. The outcome of events "skin so itchy", "nauseated/nausea" was not recovered, of events "dry heaves", "sore arm" was recovering, of "TSH is off" was recovered, of other events was unknown.
76 2021-05-28 weakness head ache; chills; fatigue; weakness; I had no appetite but drank water; This is a spontaneous repor... Read more
head ache; chills; fatigue; weakness; I had no appetite but drank water; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201; expiration date: unknown), via an unspecified route of administration, administered in left arm on 01Mar2021 11:15 (at the age of 76-year-old) as a single dose for covid-19 immunisation. The vaccine was administered at Public Health facility. The patient had no known allergies. Medical history included controlled high blood pressure. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6201), via an unspecified route of administration, administered in left arm on 08Feb2021 11:15 (at the age of 76-year-old) at a 1st dose, single dose for covid-19 immunisation. Concomitant medications included lisinopril (LISINOPRIL); naproxen sodium (SYNFLEX DS); ascorbic acid, betacarotene, biotin, boron, calcium carbonate, calcium pantothenate, calcium phosphate, chromium picolinate, cholecalciferol, copper sulfate, cyanocobalamin, folic acid, lycopene, magnesium oxide, manganese sulfate, nickel, nicotinamide, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, silicon dioxide, sodium metavanadate, sodium molybdate, sodium selenate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc oxide (SENTRY SENIOR). On 01Mar2021 at 08:00 PM, the patient experienced headache, chills, fatigue and weakness. These symptoms lasted through the following day and the majority of the second day. The patient had no appetite but drank water. The morning of the third day the patient was back to normal, no more symptoms. No treatment received for adverse event. Patient did not had COVID prior vaccination and did not had COVID tested post vaccination. Patient did not had any other vaccine in four weeks. The outcome of the events were recovered on an unspecified date in Mar2021. No follow-up attempts are possible. No further information is expected.
76 2021-05-28 discomfort, pain in extremity, weakness very exhausted; sleeping a lot/sleeping all the time; bottom neck area to ache; not able to eat anyt... Read more
very exhausted; sleeping a lot/sleeping all the time; bottom neck area to ache; not able to eat anything; mouth was very dry; achy body and lower back/felt aches and pains; achy body and lower back; went through was some kind of flu; it was hard to sleep at first; kids are watching over her, clean up stuff and doing laundry and all that; Arm hurt; discomfort; feet hurt; she could not walk; felt weak/she could not push herself up, her arm and legs would not push her up; more off balance/balance got worse; could not almost stand up; terrible stomach pains at went up and down her stomach; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 26Apr2021 (lot number: ER8731), as 1st dose, single dose, at age 76 years old, for COVID-19 immunisation, at a pharmacy/drug store. The patient medical history and concomitant medications were not reported. Historical vaccine included a flu shot for immunization and experienced hives after. In the evening of 29Apr2021, when the patient was about to go to bed, she experienced terrible stomach pains at went up and down her stomach. She almost called the ambulance. For the next 14 days (dates unspecified), she was very exhausted, was sleeping a lot/sleeping all the time causing the bottom of her neck area to ache, she was not able to eat anything for 2 days (I would just have 'brock' and cheese and crackers something easy), her mouth was very dry she had to keep hydrating, had an achy body and lower back, felt aches and pains, her feet hurt she could not walk, felt weak which made her more off balance/balance got worse (pending clarification) causing her to use a walker just to be careful. The patient stated that what she went through was some kind of flu which knocked her out, she was sleeping all the time and mentioned that it was hard to sleep at first. At one time (unknown date), as she woke up from her nap, she could not push herself up, her arm and legs would not push her up and had to be assisted by her grandson. The patient could not almost stand up. The patient reported that her kids are watching over her, clean up stuff and doing laundry and all that. The patient also experienced discomfort and her arm hurt on an unspecified date. On 13May2021, she had her first real small meal. She stated that she avoided taking medications until she gave in and took Tylenol for "bottom neck area to ache", "achy body and lower back/felt aches and pains", "feet hurt", "arm hurt", and discomfort. She stated, "I was very happy after getting the shot, I felt very good but after some days I felt like I was going to die here, should I call the ambulance, what going on with my stomach, and that's was shocking for me." The patient asked if what she experienced was normal and if she should get the second dose. The patient was recovering from the events (reported as "she was coming out of it"). Follow-up attempts are needed. Further information is expected.
76 2021-05-28 pain in extremity At the time of vaccination, I had a headache and sore arm and felt tired for 24 hrs or so. My l... Read more
At the time of vaccination, I had a headache and sore arm and felt tired for 24 hrs or so. My last check in report I would like to change my health status to serious vertigo experience beginning on May 1, 2021. In the middle of the night while in bed I felt like I was falling. The next day I had the need to fall to the left side all the way to the floor 2 times safety and felt very dizzy for the 2 days. I began my balance exercises. I continue to have frequent serious dizziness episodes since May 1. Can this recent on set of strong vertigo be a result of the vaccine? Until now all vertigo expressions were mild.
76 2021-05-31 numbness, pain in extremity, tingling Outbreak, looked like hives, on her torso and stomach area, after the first vaccine:; Chills, after ... Read more
Outbreak, looked like hives, on her torso and stomach area, after the first vaccine:; Chills, after first and second vaccine; Injection site sore after first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204, Expiration date was not reported), via an unspecified route of administration on 03Mar2021 14:00 as 1st dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. On 03Mar2021, the patient experienced outbreak, looked like hives, on her torso and stomach area, with sequelae after the first dose, chills after first and second vaccine, injection site sore after first and second vaccine, Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine (Patient visited office). she would like to know about percentages in age groups who have experienced any numbness and tingling, and if there are any correlation with developing blood clots of this, and also, she wanted to know if she needs further medical attention and to prevent a serious outcome. The outcome of the event was recovered for urticaria on 21Mar2021, the outcome of chills was unknown. Vaccination site pain, Hypoaesthesia Paraesthesia was not recovered. No follow-up attempts are needed. No further information is expected.
76 2021-06-01 nerve injury Has all those nerve damage in her intestine and they are not working; She has nerve and muscle damag... Read more
Has all those nerve damage in her intestine and they are not working; She has nerve and muscle damage in intestine and that is why she cannot eat; Has all those nerve damage in her intestine and they are not working; She has nerve and muscle damage in intestine and that is why she cannot eat; She hasn't been able to eat; This is a spontaneous report from a contactable consumer. A 76-year-old female patient (reporter's mother) at the age of 76 years old received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient previously had first dose of BNT162B2 for covid-19 immunisation. patient had the Pfizer Covid vaccine about a month ago and about 10 days after her second vaccine, she is in hospital and she hasn't been able to eat since. She is probably going to die this week. They say that there is no blockage but she has all those nerve damage in her intestine and they are not working. reporter don't know if it is related to the vaccine or not but reporter wanted to ask if anybody else is having this problem. She has nerve and muscle damage in intestine and that is why she cannot eat. She has been fed with an IV for a month now. reporter stated it just happened 10 days after her second shot, she was fine before that. She had some other health problems and issues and other things as she is an old lady, she has had some other health things but reporter don't know if it is related or not but reporter wanted to call and see if one are getting other calls about this, about nerve damage or maybe information or what was going on. Outcome of the events was unknown. Information on lot number/batch number was requested.
76 2021-06-01 seizure I63.9 - Cerebral infarction, unspecified N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmo... Read more
I63.9 - Cerebral infarction, unspecified N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia R56.9 - Unspecified convulsions
76 2021-06-02 tingling, numbness and pain down to the foot, ankle and calf areas, after second vaccine; Headache: left side and right... Read more
and pain down to the foot, ankle and calf areas, after second vaccine; Headache: left side and right side of head, frontal area, feels like it is travelling from her arm to her head, after the second vaccine; Face spasms on the left side of face; after the second vaccine and it was worsened; Chills, after first and second vaccine; Injection site sore after first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips after first and second dose; Left side of the body had tingling, numbness; This is a spontaneous report from female contactable consumer (Patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, lot number was not reported) via unspecified route of administration, administered in left arm on 31Mar2021 at 14:00 (at the age of 76-years-old) as single dose for COVID-19 immunization. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number: EN6204) via unspecified route of administration in left arm on 03Mar2021 at 14:00 as single dose for COVID-19 immunization and on same day patient experienced outbreak, looked like hives, on her torso and stomach area, chills, injection site sore (which subsided after 18-days), arm was numb, tingley and painful from the shoulder to the fingertips. Medical History and concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. No vaccinations within 4 weeks prior vaccinations. On 31Mar2021 (same day of 2nd dose of vaccination), patient experienced face spasms on the left side of face, after the second vaccine which was intermittent in the evening, headache: left side and right side of head, frontal area, feels like it is travelling from her arm to her head and left side of the body had tingling, numbness and pain down to the foot, ankle and calf areas, along with the events of first dose, which were worsened after second dose that included chills and injection site sore (which subsided 18-days after first dose), arm was numb, tingley and painful from the shoulder to the fingertips. Patient required to visit physician office, primary care doctor for her numbness, tingling and pain. Reporter stated she was very interested in percentages in age groups who have experienced any numbness and tingling and asked if there are any correlation with developing blood clots and would like the information to see if she needs further medical attention and to prevent a serious outcome and discuss it with her doctor and agrees to be transferred to Medical Information. The outcome of all the events was not recovered. No follow-up attempts are needed. No further information is expected.
76 2021-06-03 hot flush, difficulty speaking urge to have a BM; left side of head had a funny sensation; Chills; hot flashes in my upper body; fe... Read more
urge to have a BM; left side of head had a funny sensation; Chills; hot flashes in my upper body; feels strange and voice has changed; feels strange and voice has changed; suddenly had to have a bowel movement; This is a spontaneous report from a contactable consumer or other non-HCP. A 76-years-old female patient (at the age of: 76-years) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Left Arm on an unspecified date as 1st dose, single for covid-19 immunization. The patient Medical history was not reported. Concomitant medication included losartan potassium 50 mg once a day, ergocalciferol (VIT D) and calcium taken for an unspecified indication, start and stop date were not reported. No vaccination within four weeks prior to the first administration date of the suspect vaccine and No Family medical history relevant to ae and relevant tests. The patient experienced chills, hot flashes in my upper body, feels strange and voice has changed, and suddenly had to have a bowel movement on 02Mar2021, urge to have a bm and left side of head had a funny sensation on an unspecified date. she got the first dose of the Pfizer Covid vaccine this morning around 08:00 AM, then the person who gave her the shot asked her what medication she takes and she told them, they did not say anything to her about it. States she took her medication for blood pressure around 09:30 AM at her regular time to take the medication, wants to know if it is okay Takes Losartan Potassium 50mg one time a day, states she took it with Vitamin D and Calcium. And States her voice is changed, she feels strange, states around 10:20 wanted to take bowel movement suddenly, could be a regular thing, states she feels some sort of hot flash sensations not bad, here and there and then feel chills. The patient underwent lab tests and procedures which included weight fluctuates between 144 and 145 on unspecified date. The outcome of the events feels strange, and voice has changed was not resolved and other events was unknown. No follow-up attempts are possible. No further information is expected.
76 2021-06-03 numbness, tingling pt says that she has a tremendous amount of body and muscles aches with extreme fatigue. She alread... Read more
pt says that she has a tremendous amount of body and muscles aches with extreme fatigue. She already had numbness and tingling throughout her entire body (including lips and face) but became much more severe in April. In the last couple of weeks she has developed rashes on various parts of her body. Pt had appt w/ PCP. She had blood work that was negative and was referred to a Rheumatologist. On 6/3/21 she went to another doctor. She had more blood work. Pt is waiting on results. She also went to see another doctor. She had more blood work and waiting on these results. She has an appt Neurologist. She also had swelling with her gums for a couple of days. She has a very foggy feeling like she is spaced out. She feels like her vision has been impaired. She still feels bad most days saying the her symptoms come and go and she has felt this way since taking the vaccine. She has headache that come and go for the last couple of weeks.
76 2021-06-08 pain in extremity I took the Pfizer vaccine in January and had a anaphylaxis reaction which I reported earlier. This ... Read more
I took the Pfizer vaccine in January and had a anaphylaxis reaction which I reported earlier. This is not about that but a week ago I began experiencing sharp pain in my thumbs when I tried to open a jar, pull up my pants, rub my hands together, flush the commode, etc. I have never had this kind of pain before. I looked on the internet to see what might help and noticed that the pain could possibly be a reaction to the Covid vaccine. Therefore, I am reporting it to you.
76 2021-06-08 pain in extremity I have pain in my left arm since 2nd shot.; This is a spontaneous report from a contactable consumer... Read more
I have pain in my left arm since 2nd shot.; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 01Feb2021 10:45 (Batch/Lot Number: EL8982) at the age of 76-year-old, as single dose for covid-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number : EK9231) on 11Feb2021. Medical history included from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported; amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced pain in left arm since 2nd shot (pain in extremity) (non-serious) on 01Feb2021 11:00 with outcome of not recovered. Therapeutic measures were taken as a result of the event pain in extremity. No follow-up attempts are possible. No further information is expected.
76 2021-06-10 slurring Legs Wouldn't Work; she couldn't walk; Slurred speech; Really sharp pains inside her head; Lymph Nod... Read more
Legs Wouldn't Work; she couldn't walk; Slurred speech; Really sharp pains inside her head; Lymph Node Abnormal; Confused; foggy; This is a spontaneous report received from a contactable consumer (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 31Mar2021 (Lot Number: EW0150) at the age of 76 years, as a single dose, for COVID-19 immunisation. Medical history included cerebrovascular accident (Mini Strokes), TIAs ( states she has had a few of them; the last one was years ago), Car Wreck with head pain on the side of the head. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in right arm on 10Mar2021 (Lot Number: EN6208). The patient did not receive any other vaccines within four weeks prior to the vaccination On 01Apr2021 the patient experienced legs wouldn't work; she couldn't walk, she had slurred speech, really sharp pains inside her head, she was confused, and felt foggy. In April2021 she had lymph node abnormal. The patient was hospitalized from 01Apr2021 to 05Apr2021 (4 days). The patient had lab tests and procedures on unspecified date, which included computerized tomogram with Contrast: normal; electroencephalogram (EEG): abnormal; x-ray: abnormal lymph node. The verbatim chronological clinical course was reported as follows: the patient stated she received her second shot on 31Mar2021 and on 01Apr2021, she ended up in the ER and admitted to the hospital because her legs wouldn't work, she couldn't walk and she had slurred speech. The patient thinks the time of onset of the events was in the afternoon but stated it is foggy because she was a little confused at the time. Patient stated she also had a x-ray and it showed that her lymph node was abnormal. She also had really sharp pains inside her head. Patient stated that the event legs wouldn't work, couldn't walks, it was ongoing but she was doing Physical Therapy and she is starting to get back to her normal. In terms of the really sharp pain inside her Head, the patient stated that she was in a car wreck and had some head stuff and this really brought it out really sharp which she has never had before. The patient stated she thinks the vaccine just brought out her TIAs and she has had headaches in the side of her head but these were a lot sharper. The patient reported that she goes to her Neuro Doctor next week. The patient stated she went back to the doctor and he did a computerized tomogram (CT) with contrast. She stated that when she was in the hospital, her EEG was abnormal. She stated per the report of the x-ray guy, he said that the abnormal lymph node was caused from the shot, the Covid shot. She stated tomorrow she has an ultrasound or some kind of test to see if she needs to have a biopsy of the lymph node. The clinical outcome of she had slurred speech, really sharp pains inside her head, she was confused, and felt foggy was recovered. The clinical outcome of experienced legs wouldn't work; she couldn't walk, was recovering. The outcome of the remaining event was unknown.
76 2021-06-14 night sweats A few days after I got the shot I started having night sweats, nausea. The night sweats went away un... Read more
A few days after I got the shot I started having night sweats, nausea. The night sweats went away until I got my second vaccine. Now I have them every night. They are not as bad. My doctor put me on medicine. I have fluid around my heart. Pericardial effusion is what I was diagnosed with. I also have small cell vasculitis. My red blood cell dropped.
76 2021-06-15 pain in extremity redness of injection site; arm aches; itching around injection site; Swelling around injection site;... Read more
redness of injection site; arm aches; itching around injection site; Swelling around injection site; This is a spontaneous report from a contactable consumer reporting for herself. A non-pregnant 76-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in right arm on 10Mar2021 13:30, at 76 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hypertension, kidney disease, stroke survivor, breast cancer survivor and allergy to nichel and to shrimp, all from an unknown date. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in right arm on 17Feb2021 13:30 , at 76 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Concomitant medications included allopurinol, metoprolol, atorvastatin, lisinopril and rivaroxaban (XAREL), all taken for an unspecified indication, since an unspecified date. The patient didn't receive any other vaccine in the previous 4 weeks. She was not diagnosed with COVID-19 prior to vaccination and was not tested positive for COVID-19 post vaccination. On 11Mar2021 08:00 the patient experienced redness of injection site, arm aches, itching around injection site and swelling around injection site. No treatment was received for the events. At the time of the report the events had not resolved yet. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
76 2021-06-23 tremor Do not take the second dose; I will not be able to be fully covered; Started shaking specially my ha... Read more
Do not take the second dose; I will not be able to be fully covered; Started shaking specially my hands; I started to feel very giddy; My tongue started to swell up badly; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 76-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. She had many vaccines in her lifetime. The Pox vaccine to live in abroad when she was young. Then vaccine to live abroad to work. Then another country and then in another country. She had so many but she never had any reaction to anything. On 22Mar2021, the patient had started shaking specially her hands and then within the first 15 minutes then it was okay and then she started to feel very giddy like she had several glasses of champagne and then her tongue started to swell up badly. The events were considered serious as medically significant events. Patient received Benadryl as treatment for the events. On an unknown date, patient stated that she definitely do not take the second dose. So, she will not be able to be fully covered. It was reported that patients doctor send her to an allergist to see if she should take the second dose. She told that she had even get a the green pass and who knows if she could take anymore vaccine that are created for the mutant strains of this virus. Further, this was a very severe reaction, and she was on the first one not even the second one and its not acceptable. Patient stated that there are people that did not have allergic reaction to anything before in their life. These things nothing, scorpion bite nothing and this was a huge surprise. They need to know this kind of things all this other stuff. It was reported that patient was not experiencing the problem or symptoms. At the time of report, patient was recovering from the events shaking specially my hands, started to feel very giddy and tongue started to swell up badly without hospitalization. The outcome of the event Do not take the second dose; I will not be able to be fully covered was unknown and for other events was recovering. Information about batch/ lot number has been requested.
76 2021-06-23 trigeminal neuralgia Trigeminal Neuralgia - slight sensations after the first vaccine. Very strong pain after the second
76 2021-06-24 weakness I started having bad headaches about two weeks after taking dose 1. Then after the second shot, the ... Read more
I started having bad headaches about two weeks after taking dose 1. Then after the second shot, the headache started getting better but I still feel exhausted and tired all the time. I have no energy and I sit down and fall asleep and someone has to wake me and that's not normal. I go to see a cardiologists on 7/06/2021.
76 2021-06-24 pain in extremity has trouble moving her arm/ received vaccine in left arm but right arm was hurting; muscles in her r... Read more
has trouble moving her arm/ received vaccine in left arm but right arm was hurting; muscles in her right arm to her elbow was hurting; Swelling; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9246), via an unspecified route of administration, administered in left arm on 05Feb2021 02:55 (Age at Vaccination: 76 years) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included PRESERVISION (reported as eyes) for AREDS 2, 1 twice daily from Feb2021 to ongoing started a week ago; hair skin and nails (reported as stye) as 2 gummies daily on an unknown date in 2020 (reported as 3 to 4 months ago). On 06Feb2021, the patient experienced swelling. On 07Feb2021, the patient has trouble moving her arm/ received vaccine in left arm, but right arm was hurting. The patient reported that when she woke up on Saturday her right arm was hurting. She received the vaccine in her left arm. The muscles in her right arm to her elbow was hurting. She also has swelling in her arm. She used Hemp Pain Cream. She is asking if she can take any type of pain killers. She is also having trouble moving her arm. She confirms that this started after receiving the vaccine. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The events did not require a visit to emergency room or physician office. There were no prior vaccines administered within 4 weeks. The patient still had pain even after using Hemp Vana Pain Cream. Patient received treatment as Hemp Vana Pain Cream (Lot number: 37455C, expiration date: Dec2021). The outcome of all the events was not recovered. Follow-up attempts are completed. No further information is expected.
76 2021-06-24 pain in extremity First COVID-19 vaccine: arm was really, really painful; This is a spontaneous report from a contacta... Read more
First COVID-19 vaccine: arm was really, really painful; This is a spontaneous report from a contactable consumer. This 76-Year-old female consumer reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via Intramuscular route of administration on 14Jan2021 (at 76-years old) on left arm, as 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant products included thyroid pills. No further details provided or obtained regarding this statement. On 14Jan2021 15 minutes after the first vaccine her arm was really, really painful. She was up all night but she was up because her arm was in so much pain. On 15Jan2021 the patient recovered. It was mentioned that the caller declined to include a healthcare professional for this report. It was attempted to gather product information for the first and second vaccine, but caller stated that she could not read the writing. There was a product complaint: The first vaccine she had, her arm was really, really painful. She was up all night but she was up because her arm was in so much pain. Information on the lot/batch number has been requested. Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information was expected.
76 2021-06-24 tingling, muscle spasms, pain in extremity chills; the glands in her neck, under her chin were swollen and hurt a little; below knee and feet a... Read more
chills; the glands in her neck, under her chin were swollen and hurt a little; below knee and feet and toes are crampy; Her mouth has been dry and drinking more water; Her body just feels achy; injection site is sore; does not feel well; her tingling in her legs from the knee to the toe; the glands in her neck, under her chin were swollen and hurt a little; sore arm; weight is a little low at the moment; This is a spontaneous report from a contactable consumer reporting for herself. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EM9810; Expiration date: not reported), dose 1 via an unspecified route of administration, administered in left arm (in the muscle in upper arm) on 03Feb2021 (at the age of 76-years-old) as first dose, single for prevention. The patient's medical history and concomitant medications was none. After receiving the first dose, in the afternoon the patient started experiencing side effects of chills, pain in the injection site, the glands in her neck, under her chin were swollen and hurt a little, a very dry mouth and her tingling in her legs from the knee to the toe. The next day morning sore arm was better, but still experiencing the other side effects. Patient was concerned and would like to know if they were normal. The patient reported that she just got the first dose 03Feb2021 and scheduled for second dose on 24Feb2021. Her weight was a little low at the time of report as she was getting dental work done. Patient went to the site and it did not give anything in terms of if anything happened or what to expect. Patient had chills, and the glands around her neck were swollen. The injection site was sore, but she expected that. Her legs below knees and feet are crampy. Because of her age and lives alone, patient just wanted to know if this was normal. Her mouth was very dry and had been drinking water with lime she squeezed in it. This started after she got vaccinated around 11:00-11:30. Patient just wanted to know what was normal and what was not. She took temperature and does not have a temp 98.1. She just was feeling like she did not feel well. Patient wanted to know if this would pass. The place she got the vaccine, they did not give her any information except the date to return. Patient reported the day before reporting was worse. Her glands were still swollen, but not as bad. Her feet were still crampy and the toes, body just felt achy. Patient would like to know if these symptoms were normal and what the time frame was that she should expect them to continue. Investigation assessments included none. The outcome of the events chills, the glands in her neck, under her chin were swollen and hurt a little, her mouth has been very dry and drinking more water, her body just feels achy, injection site was sore and sore arm was recovering; event of below knee and feet and toes are crampy was not recovered; other events was unknown. Follow-up attempts are completed. No further information is expected.
76 2021-06-29 weakness felt real weak in her legs; not feeling well; Stomach upset; felt weak; This is a spontaneous report... Read more
felt real weak in her legs; not feeling well; Stomach upset; felt weak; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number, NDC number and expiry date was not provided), dose 2 via an unspecified route of administration on 03Feb2021 (at the age of 76-years-old), as dose 2, single for covid-19 immunization. Medical history included ongoing asthma diagnosed when she was a child. There were no concomitant medications. Family medical history relevant to ae was not provided. The patient had previously taken the first dose of the bnt162b2 (batch number: EL9263) on 13Jan2021 (at 13:30-16:00, as reported) for covid-19 immunization (Unknown dose shot in right shoulder once, as reported). Patient age at first and subsequent immunizations if dates of birth or immunizations not available was not provided. No other medication were administered within four weeks prior to the first administration date of the suspect vaccine. Prior vaccinations patient had no adverse event. The patient stated that she felt real weak in her legs. Clarified that it is for the Pfizer Coronavirus shot. Wanted to know what to do about it. It was reported that the patient feeling weak started 3 days ago and feeling week in her legs which started 2 days ago. The patient stated she is still doing what she has been doing. Vaccination facility type was nursing home. On an unspecified date, the patient experienced "felt real weak in her legs", not feeling well, on 07Feb2021 felt weak and at 20:00, stomach upset. The adverse events did not cause emergency room or physician office visit. Treatment was for taken with Pepto Bismol as a result of stomach upset. Outcome of the events were not recovered. Follow-up attempts completed. No further information expected.
76 2021-06-29 pain in extremity couldn't sleep, up all night; chills; With the second vaccine, her arm hurts; This is a spontaneous ... Read more
couldn't sleep, up all night; chills; With the second vaccine, her arm hurts; This is a spontaneous report from a Contactable Consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: E20792 (but she doesn't know for sure) and Expire Date: unknown) intramuscularly administered in left arm on 04Feb2021 10:15 (at the age 76-year-old) as dose 2, single for COVID-19 immunisation. Patient took her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) intramuscularly administered in left arm on 14Jan2021 (at the age of 76 years), and stated that arm was really, really painful on 15Jan2021. Vaccination facility type was physician's office. The patient's medical history was not reported. She mentions she takes thyroid pills as concomitant medication. No further details provided or obtained regarding this statement. None of the additional vaccines administered on same date of the suspect. The patient did not receive any Prior vaccines within 4 weeks. With the second vaccine in feb2021, her arm hurts but it is not anything she cannot stand. However, she didn't sleep again all night last night. She was so tired but she could not sleep. She has taken other medications and she does have insomnia. She has tried melatonin for sleep and it worked just the opposite. It kept her up all night. Caller verifies she has no NDC, Lot number or expiry date for the melatonin, this was a while back. She mentions someone also told her to take Benadryl which typically makes one sleepy but she stayed up all night when she took it. She confirms she has no NDC/UPC, Lot, or expiry date to provide. She took that a while back. She was just wondering if the vaccine could cause patient not to sleep it was weird. The first vaccine she had, her arm was really, really painful. She was up all night but she was up because her arm was in so much pain. She just inquired if this could be a side effect of the vaccine and there been any reports of this. In Feb2021,She also had the chills which she read was normal. She mentions she does have sleep medication but she didn't know if it was safe to take after having a shot. Every once in a while she takes it. Caller mentions she did have a blood test done, not too long ago. Like cholesterol and everything and it was good. Caller verifies this was prior to receiving the vaccine. Caller was curious if this common or anybody else have trouble sleeping after receiving the vaccine. No emergency room visit and physician office visit was reported. Treatment was received for couldn't sleep, up all night. The outcome of events was unknown. No further details were provided or obtained. Follow-up attempts are completed. No further information is expected.
76 2021-07-06 pain in extremity, weakness Stumbled and broke her right arm in 3 places; Stumbled and broke her right arm in 3 places; Got a bi... Read more
Stumbled and broke her right arm in 3 places; Stumbled and broke her right arm in 3 places; Got a big chip in her hip; Chipped the acetabulum on her pelvis, there is a big chip on that, but it did stay in place, so no surgery is needed; Precipitous drop in energy level; Fuzzy mentally; Acute lethargy; A little arm soreness; Low blood pressure; She wasn't feeling well; In a lot of pain with the chip in her hip; Fell on her right side and it was in her house, of course, on her tile floor; Low cholesterol; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206; Expiration date was not reported) on the right deltoid on 11Mar2021 (09:45) as a 2nd dose, single, with route of administration unspecified, for COVID-19 immunization at the clinic (not in a military facility). Medical history included ongoing hypothyroidism diagnosed probably 10 years ago. Concomitant medication included levothyroxine for hypothyroidism. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on 17Feb2021 on the left deltoid for COVID-19 immunization. On 12Mar2021, the patient had a little arm soreness. On 13Mar2021, the patient had precipitous drop in energy level (50% drop in energy her level; then 30% down at the time of reporting); was fuzzy mentally enough that her friends event noticed it; and had acute lethargy. On 20Mar2021, the patient had stumbled, and right arm x-ray AC and lateral showed she broke her right arm in three places; got a big chip in her hip; and right hip x-ray showed she had chipped the acetabulum on her pelvis (there was a big chip on that), but it did stay in place, so no surgery was needed. The patient had a surgery on the right arm, and had to have a 4-hour surgery to replace the Olecranon where it should have been, and a plate and a couple of screws. The events, 'stumbled and broke her right arm in three places', 'got a big chip in her hip' and 'chipped the acetabulum on her pelvis', were assessed as serious (medically significant). On an unspecified date in 2021, the patient had low blood pressure (110/60); was not feeling well due to the second dose of vaccination; was in a lot of pain with the chip in her hip; fell on her right side and it was in her house, of course, on her tile floor; and had low cholesterol. The reported events had resulted into an emergency room visit and physician's office visit (orthopedics). The outcome of the events was recovering for 'stumbled and broke her right arm in three places', 'precipitous drop in energy level', 'fuzzy mentally' and 'acute lethargy'; was not recovered for 'got a big chip in her hip'; was recovered on 14Mar2021 for 'arm soreness'; and was unknown for all the other events. No follow-up attempts are possible. No further information is expected.
76 2021-07-07 weakness Pt call hospital call center on 5/26/21 c/o Shortness of breath, rapid heartbeat and weakness start... Read more
Pt call hospital call center on 5/26/21 c/o Shortness of breath, rapid heartbeat and weakness started 2 days ago. Patient stated received covid vaccine 2nd dose 5/22/2021 which she received at outside pharmacy. Pt advised to go to ED but she declined. ED education were reiterated to patient.
76 2021-07-08 burning sensation Tingling in my tongue and lower lip; It is like if you put pepper on your tongue, I am feeling it fr... Read more
Tingling in my tongue and lower lip; It is like if you put pepper on your tongue, I am feeling it from the tip of tongue to the sides of my tongue like from the tip you go towards you jawline; It is like burning and it started out as tingling; It feels like it is there and there is something wrong; This is a spontaneous report from a contactable nurse. This 76-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9265, expiration date was not reported), intramuscularly in right upper arm on 02Mar2021 (age at the time of vaccination was 76-years-old) as single dose for COVID-19 immunization. The patient took the shot at 11.30 yesterday morning, got the shot at around 11:10 AM, the patient was asked to wait for 15 minutes and the patient waited for 25 minutes. The patient's medical history included high blood pressure and it was controlled and taking high blood pressure medication, anxiety. The patient's concomitant medications included the patient take Synthroid and Levothyroxine because the patient had thyroid gland removed years ago (not clarified further) and Sertraline, which was Zoloft (not clarified if consumer was taking Zoloft or Sertraline, hence not captured in tab), 50 mg for anxiety. On an unknown date, the patient would reduce it to a burning, yesterday it was more pronounced, and it continued all night, so the patient didn't sleep flat. The patient was not sure if it will get to anaphylactic or anything, it was like put pepper on tongue, that was best description that the patient can give, it was like if put pepper on tongue, the patient felt it from the tip of tongue to the sides of my tongue like from the tip go towards the jawline and it was not under whole tongue, it was right around it and it was like burning and it started out as tingling and sometimes, it does like it did today morning (on the day of reporting), but it was not a severe tingling but it was felt like it was there and there was something wrong (not clarified appropriately further, hence ongoing not checked). The patient did not received any treatment and was just ready to go hospital if the patient had to just in case but there was nothing. The patient had no breathing problem and nothing at all. The outcome of the event was not resolved. The patient was hesitated to get the second dose. The patient just wanted to report the side effect that did not see in the list and all of the literature. No follow up attempts are possible. No further information is expected.
76 2021-07-13 tremor tremor; insomnia; intense itching; loose stools; This is a spontaneous report from a contactable con... Read more
tremor; insomnia; intense itching; loose stools; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was reported as unknown) via an unspecified route of administration on 26Feb2021 at 10:30am (at the age of 76-years-old) in left arm as dose number unknown, single for covid-19 immunization at Hospital. Medical history included breast cancer and known allergies as IgG reactions to many substances both from an unknown date and unknown if ongoing. No other vaccine taken on same date. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks. Concomitant medications received within two weeks included pregabalin (LYRICA); ascorbic acid (VITAMINS C); colecalciferol (VITAMIN D [COLECALCIFEROL]); melatonin (MELATONIN) and fexofenadine hydrochloride (ALLEGRA) all taken for an unspecified indication, start and stop date were not reported. The patient experienced delayed reaction two days after vaccination which included intense itching, insomnia, loose stools, and tremor on 01Mar2021. The patient received treatment for the adverse events occurred. The outcome of the events was Recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
76 2021-07-14 weakness Husband reported weakness in left arm the evening of vaccination. Patient's health has declined. She... Read more
Husband reported weakness in left arm the evening of vaccination. Patient's health has declined. She now needs assistance with moving from chair to bed. She can walk once she is on her feet, but cannot get to her feet by herself. Just very week.
76 2021-07-17 feeling hot, tenderness, pain in extremity Since February 19th I have been in constant pain. Difficulty in walking, exercising, and every day a... Read more
Since February 19th I have been in constant pain. Difficulty in walking, exercising, and every day activities. 1. Covid Toes: One inflamed, swollen and discolored toe on each foot. Constant pain. Painful to touch. Spurts of searing, burning pain on back side of toe. 2. Exacerbated arthritic pain in both hands. Joints in fingers and thumb are swollen and extremely painful. Voteran for treatment. Referral to Rheumatologist
76 2021-07-17 hypersensitivity of all senses Second dose: lymph nodes under jaw still swollen; Second dose: dizzy; Second dose: rapid heartbeat; ... Read more
Second dose: lymph nodes under jaw still swollen; Second dose: dizzy; Second dose: rapid heartbeat; Second dose: almost passed out; Second dose: throat tightened; Second dose: jaw was tender; Second dose: lymph nodes under jaw were tender; Second dose: jaw was tender/Second dose: lymph nodes under jaw were tender; Second dose: tired; Second dose: nauseous; Second dose: diarrhea; Second dose: muscle pain; Second dose: joint pain; Second dose: chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 30Jan2021 (76-years-old at the time of vaccination), (Batch/Lot Number: EL9265, Expiry date May2021) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection dose 1 via an unspecified route of administration, administered in Arm Right on 09Jan2021 12:30(76-years-old at the time of vaccination), (Batch/Lot Number: EL3248; Expiration Date: Apr2021) as DOSE 1, SINGLE for covid-19 immunisation and experienced throat started tightening, Lymph nodes under her jaw were sensitive to the touch, feeling more and more tired, entire body was leaden with lethargy, couldn't do anything, all her joints were aflame, nauseous, pain in muscles, pain in joints, couldn't raise either of her arms, chills, low grade fever of 99.2 degrees Fahrenheit, Fatigue. Patient was dreading getting the second Covid 19 vaccine. One of the questions on the questionnaire she filled out prior to getting her second dose was if she had a severe reaction to any vaccine. She answered yes but no one at the facility asked her about it. She put that she may have had a severe reaction with the first Covid 19 vaccine but no one at the facility questioned it. She put question marks on the questionnaire on that question to indicate she didn't know if she had a severe reaction for sure or not. She did want to have protection against the Covid 19 virus, so she did get the second Covid 19 vaccine. After getting the second Covid 19 vaccine she experienced the same thing going home. Her throat tightened. Her jaw and lymph nodes under her jaw were tender. She was tired but didn't feel the leaden feeling she had with the first Covid 19 vaccine. She was nauseous and had diarrhea. She had muscle pain and joint pain and chills. These symptoms went on for 5 days. She thought she would be ok after the 5 days like she was after her first Covid 19 vaccine dose. On the sixth day she almost passed out in the grocery store. She had to sit on the floor of the grocery store and put her head between her knees. She was dizzy. She was still having the diarrhea, nausea, and chills. It was like having influenza symptoms. She went home that day and got into bed. Then gradually she got better. Maybe around the 9th day after the vaccine she was able to do some things around her house and on the 10th day she was better. Her lymph nodes under her jaw were still swollen. She doesn't know if what she experienced were normal side effects. She found the Pfizer reporting website obtuse. The website indicates there was a time limit to finish a report. She did not file online because she wasn't sure she'd be able to finish in the time limit. She was grateful for protection against the Covid 19 virus and would get the Covid 19 vaccines all over again, but she was not looking forward to getting a Covid 19 vaccine booster. She reported she was very healthy and active. When probed if she had seen her primary care doctor or gone to the emergency department, she reports the hospital was far away. She was living in a rural area in the mountains and did not trust the closest hospital to her. Her doctor friend who was an ophthalmologist told her that her antibodies were really kicking in and that's why she had the reaction to the Covid 19 vaccine like she did. When probing adverse events following any other vaccines, she reports she hasn't had a vaccine since childhood and doesn't remember having any adverse events from her childhood vaccinations. The last vaccine she had prior to the Covid 19 vaccine was the cold vaccine she received in 1992. She'd like to add she also had a rapid heartbeat with the dizziness on the day she almost passed out in the grocery store. That was the sixth day after the second Covid 19 vaccine on 05Feb2021. Her heartbeat was rapid for about a week after starting on 05Feb2021. The clinical outcome of the events lymph nodes under jaw still swollen was not recovered, remaining all events was unknown. No Follow up attempts are possible: No Further information is excepted.
76 2021-07-17 hypersensitivity of all senses Couldn't raise either of her arms; Chills; Low grade fever of 99.2 degrees Fahrenheit; Sick for 5 da... Read more
Couldn't raise either of her arms; Chills; Low grade fever of 99.2 degrees Fahrenheit; Sick for 5 days after receiving her first Covid 19 vaccine with flu like symptoms; Throat started tightening; Jaw was sensitive to the touch/tightening of her jaw; Lymph nodes under her jaw were sensitive to the touch; Jaw was sensitive to the touch/Lymph nodes under her jaw were sensitive to the touch; Feeling more and more tired; Entire body was leaden with lethargy; All her joints were aflame; Nauseous; Pain in muscles; Pain in joints; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration in Arm Right on 09Jan2021 12:30(76-years-old at the time of vaccination), (Lot Number: EL3248; Expiration Date: Apr2021) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included cold vaccine and experienced sickness for a week (The COVID 19 vaccine is the first vaccine she's had since 1992. The last vaccine she received was called the cold vaccine. Clarified this vaccine was for the common cold). The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported that She was calling about the COVID 19 vaccine. On 09Jan2021, the patient experienced, throat started tightening, jaw was sensitive to the touch, lymph nodes under her jaw were sensitive to the touch, feeling more and more tired, entire body was leaden with lethargy, all her joints were aflame, nauseous, pain in muscles, pain in joints, chills, low grade fever of 99.2 degrees Fahrenheit, she was sick for 5 days after receiving her first COVID 19 vaccine with flu like symptoms and on 10Jan2021, experienced couldn't raise either of her arms. She wanted to report her side effects because her side effects were dramatic. She wanted to contribute to the research being done on the COVID 19 vaccine. She reported with the first dose of the COVID 19 vaccine she waited the 15 minutes after receiving the dose and got in her car. She lived about 20 minutes from the vaccine facility. Her throat started tightening and her jaw and lymph nodes under her jaw were sensitive to the touch. She had errands to run but she felt herself feeling more and more tired. She needed to eat something, but she hadn't. She couldn't do anything. It was like her entire body was leaden with lethargy. She went home and took a nap for a couple hours. When she woke up from her nap all her joints were aflame. She felt nauseous. She got up to go to the bathroom and went back to bed. The next time she woke up she had pain in her muscles and joints. She has a friend who is a doctor and he told her to take some Acetaminophen. She took the Acetaminophen and went back to sleep and woke up the next day. When she woke the next day on 10Jan2021, she couldn't raise either of her arms. She couldn't raise the arm she got the vaccine in or the other arm. She couldn't reach up to get things out of her cabinets. She also had chills the first night after getting the first dose of the COVID 19 vaccine. She took Acetaminophen again and it eased her muscle and joint pain. She also had a low-grade fever of 99.2 degrees Fahrenheit. Her normal body temperature is low around 97.8 degrees Fahrenheit. She reported she was sick for 5 days after receiving her first COVID 19 vaccine with flu like symptoms. She didn't feel like she could get up and do her normal life for 5 days. On the last day, day 5, most of the other symptoms had gone away. She only had fatigue. The lymph nodes were very slow going getting better as well as the tightening of her jaw, that lasted a long time. She was grateful for protection against the COVID 19 virus and would get the COVID 19 vaccines all over again, but she is not looking forward to getting a COVID 19 vaccine booster. The patient underwent lab tests and procedures which included body temperature: 99.2 degrees Fahrenheit on 09Jan2021 Normal body temperature is low around 97.8 degrees Fahrenheit. Therapeutic measures were taken as a result of, all her joints were aflame, pain in muscles, pain in joints, low grade fever of 99.2 degrees Fahrenheit as Acetaminophen. The clinical outcome of the events Jaw was sensitive to the touch/tightening of her jaw, Lymph nodes under her jaw were sensitive to the touch was recovering, Fatigue not recovered, remaining all other events were recovered on 14Jan2021. No follow up attempts are possible. No further information is expected
76 2021-07-19 pain in extremity headache; dizziness; fever; chills; Strong stomach pains; nausea; vomiting; distorted taste; new bli... Read more
headache; dizziness; fever; chills; Strong stomach pains; nausea; vomiting; distorted taste; new blisters on toes; finger pain; armpit pain; fatigue; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 16:00 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to sulfa drugs, lidocaine, penicillin and mouthwash. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included aspirin (MANUFACTURER UNKNOWN) 325mg one pill per day. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 14Feb2021 at 09:45 (at the age of 75-year-old) as single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 08:00 the patient experienced headache, dizziness, fever, chills, strong stomach pain, nausea, vomiting, distorted taste, new blisters on toes, finger pain, armpit pain, fatigue and brain fog. The patient did not receive any treatment for the events. The clinical outcome of the events headache, dizziness, fever, chills, strong stomach pain, nausea, vomiting, distorted taste, new blisters on toes, finger pain, armpit pain, fatigue and brain fog was recovered with sequela on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
76 2021-07-21 hot flush anxiety attack on Feb 5 and again on Feb 17...did not seek medical attention...took a baby aspirin a... Read more
anxiety attack on Feb 5 and again on Feb 17...did not seek medical attention...took a baby aspirin and a half a muscle relaxer. both dissapated on their own. Had another much more serious attack June 15 with heart rate at 126...visited ER...they did ECG but after waiting in receiption for over an hour my heart rate and bp were back down within normal range. Have also been having "flushes" through my system like warm water is being put into my system...lasts seconds..sometimes increased heart rate other times not. June10-11 major spike in blood pressure. with 3 day hospital vist as a result. Now on BP meds.
76 2021-07-21 seizure Tingling sensation on their lips and tongues; head and room spinning; seizure; The initial case was... Read more
Tingling sensation on their lips and tongues; head and room spinning; seizure; The initial case was missing the following minimum criteria: unspecified suspect product. Upon receipt of follow-up information on 07Jul2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6205) via an unspecified route of administration, on 06Mar2021 (at the age of 76 years old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included allergy to many antibiotics wherein the patient got hives or intense vomiting, and an ongoing high blood pressure. Concomitant medication included an unknown high blood pressure medication. The healthcare professional also said for her to stop taking it because of that sensation she had on her lips and tongue. On 06Mar2021, immediately after the vaccination, it was reported that the patient experienced tongue and lips were tingling. The nurse had the patient stayed for 30 minutes longer until sensation disappeared. The patient was admitted to the hospital and did not receive any treatment for the event. 7 hours later, the patient experienced that her head and room was spinning so intensely she couldn't function or open her eyes. The patient's husband wanted to take her to the hospital, but due to COVID, the patient was afraid to go. The spinning lasted for 7 hours. The patient did go to a neurologist to be sure that she didn't have a tumor, the doctor said that she was fortunate that she didn't have a stroke. The patient had an MRI brain scan to be sure she didn't have any prior issues that may have caused that seizures. She never experienced the dizziness and intense length of time. The outcome of the event "tingling sensation on their lips and tongues" was recovered on 06May2021, vertigo was recovered on unspecified date in Mar2021, while for the remaining event was unknown.
76 2021-07-22 nerve pain Patient states that a few hours after getting second vaccination she experienced edema and nerve pai... Read more
Patient states that a few hours after getting second vaccination she experienced edema and nerve pain in her legs that traveled up past her ankle causing her to not be able to sleep. She does have some edema and neuropathy as part of her history but she states that this was much more severe than normal.
76 2021-07-28 face paralysis I63.9 - Stroke (cerebrum) (CMS/HCC) R29.810 - Facial weakness
77 2021-01-07 bell's palsy, facial paralysis Facial drooping on 1/4/2021 6 days after the vaccine suffered a mild TIA or bells palsy event. appo... Read more
Facial drooping on 1/4/2021 6 days after the vaccine suffered a mild TIA or bells palsy event. appointments for a CT scan. Has mild facial drooping on the side that is already affected by TIA / cerebral hemorrhage. The long-term or permanent outcome is unknown.
77 2021-01-07 pain in extremity arm was slightly swollen; rash around the injection site; Arm soreness; This is a spontaneous report... Read more
arm was slightly swollen; rash around the injection site; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: unknown), via an unspecified route of administration on 02Jan2021 08:00 at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient noticed her arm was sore a few hours after vaccination on 02Jan2021. Yesterday on 03Jan2021, her arm was sore. On 04Jan2021, when getting dressed she noticed her arm was slightly swollen and there's a rash around the injection site. Outcome of the events was unknown.
77 2021-01-11 feeling hot 20 MINUTES AFTER RECEIVING VACCINE, SHE COMPLAINED THAT SHE FELT A HOT SENSATION THROUGH HER BODY RI... Read more
20 MINUTES AFTER RECEIVING VACCINE, SHE COMPLAINED THAT SHE FELT A HOT SENSATION THROUGH HER BODY RIGHT AFTER THE VACCINE THAT LEFT AS QUICK AS IT CAME. SHE COMPLAINED OF FEELING LIKE THERE WAS A "LUMP IN HER THROAT". SHE DENIED ANY SWELLING OR DIFFICULTY BREATHING, ONLY THAT IT FELT LIKE A LUMP IN HER THROAT. THIS SYMPTOM GOT BETTER IN BY THE TIME SHE LEFT THE HD AT NOON.
77 2021-01-11 feeling hot Red, warm, swollen, pain
77 2021-01-12 flushing patient complained of "flushed feeling" within 7 min of receiving vaccine; 2 min later c/o "tongue ... Read more
patient complained of "flushed feeling" within 7 min of receiving vaccine; 2 min later c/o "tongue feels funny". Benadryl given, symptoms resolve
77 2021-01-18 pain in extremity A little bit of tiny soreness in my arm; It is about the same that I would get from a flu shot; This... Read more
A little bit of tiny soreness in my arm; It is about the same that I would get from a flu shot; This is a spontaneous report from a contactable nurse (patient) and another nurse. This nurse reported similar events for two patients. This report refers to the wife. A 77-year-old female patient received first dose of BNT162B2 (lot number: EL3246, expiry date: 30Apr2021), via an unspecified route of administration on 06Jan2021 at single dose in the right arm for "to prevent getting Covid/COVID-19 vaccination". There were no medical history and concomitant medications. The patient previously took a flu shot and had soreness in her arm. The patient stated, "I am fine. I am not having any symptoms at all. A little bit of tiny soreness in my arm, it is about the same that I would get from a flu shot but that's it I am not sick, I don't have any temperature". The outcome of the event was unknown.; Sender's Comments: Linked Report(s) :PFIZER INC-2021028796 same reporter/drug, different event
77 2021-01-19 weakness Complaints of dizziness and weakness resulting in a fall with injury, hypoxia (resulting in initiat... Read more
Complaints of dizziness and weakness resulting in a fall with injury, hypoxia (resulting in initiation of supplemental oxygen continuous since 1-16-2021),acute hypotension, elevated heart rate, complaints of feeling unwell, increased confusion.
77 2021-01-20 weakness Weakness Disorientation
77 2021-01-20 pain in extremity sore arm, chills, low-grade fever, muscle aches, foot pain (arthritis?), loss of appetite, fatigue (... Read more
sore arm, chills, low-grade fever, muscle aches, foot pain (arthritis?), loss of appetite, fatigue (enough to go to bed), stayed in bed all afternoon, got up for dinner (couldn't eat normal amount) and went back to bed and slept all night. Woke up ok on January 21 but still have light fatigue.
77 2021-01-20 tingling Approx 1 hour after injection (arm ok) top of head near crown on left side felt pressure extreme sor... Read more
Approx 1 hour after injection (arm ok) top of head near crown on left side felt pressure extreme soreness to touch and like nerves were tingling. Did not have any of this before injection. This went on for rest of evening , all next day. Next morning was back to normal. Never any severe pain just pressure and soreness. Got inj. At 3:35 on Tuesday 1-19 2021 started feeling apps 4:30 same day into night. All next day Wednesday 1-20-2021 into night. Next morning Thursday 01-21 it was gone. Could not stand to touch that area on top of head.
77 2021-01-22 tremor 10:00am done with shot, 1/2 hour observation, 10 to 15 minutes later driving home felt need to have ... Read more
10:00am done with shot, 1/2 hour observation, 10 to 15 minutes later driving home felt need to have a BM, arriving home had diarrhea then tremors of both hands, fast heart, and extreme tiredness
77 2021-01-24 feeling hot within 45 minutes my face turned bright red and felt very warm lasted for a day and a half otherwise... Read more
within 45 minutes my face turned bright red and felt very warm lasted for a day and a half otherwise felt fine
77 2021-01-24 numbness, tingling While waiting 15 min. following vaccine administration in clinic waiting room per clinic protocol, p... Read more
While waiting 15 min. following vaccine administration in clinic waiting room per clinic protocol, pt. began experiencing numbness and tingling in arm where vaccine was administered. Symptoms went down patient's arm into hand/fingers. Pt. declined need for medical attention at the hospital and reported she just wanted to return home. Encouraged pt. to call HCP with any further symptoms or worsening of numbness/tingling. Pt. left clinic. Follow-up phone call made to patient in afternoon at approx. 1520 (01/21/2021). Pt. reported that symptoms had resolved at time of follow-up phone call and denied further need for medical attention.
77 2021-01-24 numbness, tingling Entire left side of my bod y, from head to foot, became numb and tingly very suddenly. I called 91... Read more
Entire left side of my bod y, from head to foot, became numb and tingly very suddenly. I called 911 to make certain I was not experiencing a stroke. EMT assured me I was not. This was Saturday night. It is now Monday morning, January 25, and the numbness has not gone away.
77 2021-01-24 pain in extremity Noticed the next day after the vaccination my arm was sore, then itching with hives. Took Benadryl a... Read more
Noticed the next day after the vaccination my arm was sore, then itching with hives. Took Benadryl and put some cortisone on it to stop the itching.
77 2021-01-24 pain in extremity Sore arm and muscle aches less than 24 hours
77 2021-01-24 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer (patient's husband). This reporte... Read more
Sore arm; This is a spontaneous report from a contactable consumer (patient's husband). This reporter reported similar events for two patients. This is 2nd of 2 reports. A 77-year-old female patient received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 11Jan2021 12:00 PM at single dose for covid-19 immunisation. Patient's medical History and family medical history was none. No additional vaccines administered on same date of COVID vaccine. No other vaccines were received within 4 weeks prior to the first administration date of COVID vaccine. The patient's concomitant medications were none.The patient got the Pfizer Covid-19 vaccine yesterday and had sore arm on12Jan2021. The patient's soreness in arm didn't start until this morning, 24 hours later. It's not a real big problem for her and it's getting better and almost gone. The outcome of the event was recovering. Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026388 same reporter/product/Event, different patient.
77 2021-01-24 tingling, numbness Saturday evening 1/23/21 after vaccine, just all of a sudden from one moment to the next, left hand ... Read more
Saturday evening 1/23/21 after vaccine, just all of a sudden from one moment to the next, left hand was very tingly and tight feeling and could not move very easily. A few minutes later her lip from the center left was also tingling, and then spread to entire left side of her body from head to feet, like her left side feel asleep that tingly feeling and numbness. Began to be worried, called 9-1-1 and the EMT reassured her that she was not having a stroke, and told her that they had heard of it before. Still today, Monday 1/25/21, particularly in her left hand which she is not able to use very much. Did take Ibuprofen but nothing else.
77 2021-01-24 tremor Nausea and violent vomiting for 2 hours. Upper back and neck pain for 36 hours. Chills and shakin... Read more
Nausea and violent vomiting for 2 hours. Upper back and neck pain for 36 hours. Chills and shaking for 12 hours. Urine is now colorless instead of yellow-orange. I have had no treatment. Urine remains colorless, but other symptoms are almost resolved.
77 2021-01-25 weakness Approximately 25 minutes after receiving the vaccine, pt. started c/o headache. Upon assessment, pt... Read more
Approximately 25 minutes after receiving the vaccine, pt. started c/o headache. Upon assessment, pt. appeared to be weak and lethargic. BP: 130/74, HR: 42, RR: 16, O2 sats: 93-98%. No other symptoms noted at this time. Local EMS was called for assessment. Pt. and daughter decline taking patient to emergency room, but is going to make an appt. with PCP at this time.
77 2021-01-25 flushing, flushing Headache / Pruritus / erythema/flushed / elevated B/P
77 2021-01-26 feeling cold After a few days, muscle/joint pain ....headaches.....Tiredness......injection sit pain.... all were... Read more
After a few days, muscle/joint pain ....headaches.....Tiredness......injection sit pain.... all were bearable and strong to disappear when i waek after the short I got Horrible chills, completely out of control, had to wear my night guard to stop teeth from getting chipped, lasted 3 or four hours. Could not warm up, had two down comforters on. The chills eventually stopped but the headaches Intensified, also I could. Or move my near and shoulders. Went to the ER, they did not believe it had anything to do with the shot, I was there for 12 hours, had head exrays, spinal taps to test for meningitis, they searched for anything else I might have...nothing else.. they would not say if I should have the second shot, called pfiser this morning, they could not tell me if I should have the second shot, that I should aske my doctor.......If Pfiser doctor does not know if it is safe how could my country doctor.
77 2021-01-26 pain in extremity Very Soar Arm and tired first day. Second day, Soar Throat when swallowing, Swollen Eyes in the mor... Read more
Very Soar Arm and tired first day. Second day, Soar Throat when swallowing, Swollen Eyes in the morning when I woke up, increased blood pressure at times and not as stable when walking. Very Tired. Took Benedryl on second day, one in morning and one at night. Seemed to calm symptoms. Soar Throat lasted two days and much better today (day 3). Left Arm also less soar today and stability when walking seems better...
77 2021-01-27 weakness, tremor Palpitation, shaking, weakness, sudden onset on 1/27/21 at 8:00am. Was seen in the ED and found to ... Read more
Palpitation, shaking, weakness, sudden onset on 1/27/21 at 8:00am. Was seen in the ED and found to be in sinus tachycardia; resolved without intervention.
77 2021-01-27 burning sensation Burning sensation of lips at 14 min post vaccine folliwed by mildly swollen upper lip. Then started ... Read more
Burning sensation of lips at 14 min post vaccine folliwed by mildly swollen upper lip. Then started feeling ill and lightheaded so reportedto site nurse/ems. Bp 190/100 which I have never experienced before. Bp on diovan 80 mg typically 110/60; without diovan is 140/80 -90. Given 2 benadryl and monitored and given 2 more. About 60-90 min bp 155/90 and I went home. Took more benadryl and bp 134/80 this morning and have not taken ot for 10 hrs but feel ok. No local rx.
77 2021-01-27 pain in extremity arm soreness; This is a spontaneous report from a contactable consumer (patient) received via a Pfiz... Read more
arm soreness; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies- there's a whole list of things she couldn't take; carried an epi pen for years. Concomitant medication included cetirizine hydrochloride (ZYRTEC) to avoid allergies. The patient had the 1st dose yesterday and she's feeling good. She had no side effects except for a little bit of arm soreness on Jan2021. Her doctor told her to take Tylenol for arm soreness, but another woman told me not to take Tylenol, but the patient didn't need it anyway (unknown if treatment was received). Her doctor was giving her Zyrtec to avoid allergies because there's a whole list of things she couldn't take and have carried an epi pen for years. She took Zyrtec before having the vaccine and would take another before the second dose. Would this make the vaccine less effective? Her appointment was 16Jan2021 and she have already scheduled for 08Feb2021. Do they give you a timetable? What was the timing of the 2nd dose of vaccine? The outcome of the event was unknown. Information on the lot/batch number has been requested.
77 2021-01-28 flushing Switching vision & lightheadness & felt flushed. vitals obtained; water & juice given. started fee... Read more
Switching vision & lightheadness & felt flushed. vitals obtained; water & juice given. started feeling better, continued to observe & walked with pt & rechecked vitals
77 2021-01-28 tingling 1/26/21 @ 5PM C/O TINGLING ALL OVER BODY AND RIGHT EYE". DENIES ANY TROUBLE BREATHING OR SWALLOWING,... Read more
1/26/21 @ 5PM C/O TINGLING ALL OVER BODY AND RIGHT EYE". DENIES ANY TROUBLE BREATHING OR SWALLOWING, NO EDEMA OF LIPS. A/0 X3, SKIN PINK W/D, RESP REG WITH EASE. 1/26/21 @ 5:15PM CLIENT STATES SYMPTOMS ARE THE SAME AND "WILL TAKE BENADRYL WHEN SHE GETS HOMEIF NEEDED". 1/27/21 @ 9:25AM CLIENT STATES ALL SYMPTOMS HAVE RESOLVED.
77 2021-01-29 weakness Dizziness, Chills, Diarrhea Nausea Weakness, Tiredness
77 2021-01-30 tremor, pain in extremity Chills; Sore Arm; Shakes; Anxiety; Dizzy
77 2021-01-31 feeling hot ABOUT AN THIRTY MINUTES OR SO AFTER THE SHOT THE PALM OF MY HANDS AND BOTTOMS OF MY FEET STARTED HEA... Read more
ABOUT AN THIRTY MINUTES OR SO AFTER THE SHOT THE PALM OF MY HANDS AND BOTTOMS OF MY FEET STARTED HEATING UP AND TURNING RED. I TOOK A BENADRYL AND IT HELPED A LITTLE. SUNDAY THE SHOT SITE STARTED TURNING RED AND WAS SWOLLEN A LITTLE LARGER THAN A QUARTER.
77 2021-01-31 pain in extremity Felt ill, tired, achy. No fever detected. Sore arm, nothing too serious. Symptoms lasted one day.
77 2021-02-01 numbness she is having a problem with balance and dragging her right leg/balance was off; felt foggy; She has... Read more
she is having a problem with balance and dragging her right leg/balance was off; felt foggy; She has to walk very slowly; her arm started to feel funny. Patient stated it was not painful but felt numb; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982; expiration date: 31May2021), via an unspecified route of administration (anatomical location: Arm left) on 18Jan2021 at 14:30 at 0.3 mg, SINGLE DOSE for COVID-19 immunisation. Patient's medical history included 'hyperthyroid' from an unknown date and unknown if ongoing. Patient has no prior vaccinations within 4 weeks. There were no additional vaccines administered on the same date of Pfizer suspect. Patient has no history of previous immunizations with the Pfizer vaccine considered as suspect as this was the first dose. Concomitant medications included levothyroxine sodium (L-THYROXINE [LEVOTHYROXINE SODIUM]) for 'hyperthyroid'. The patient reported that she received her first dose of COVID vaccine yesterday (18Jan2021) afternoon at 2:30. Patient stated that at 09:00 pm last night (18Jan2021), her arm started to feel funny. Patient mentioned that it was not painful but felt numb. Patient stated that today (19Jan2021), when she woke up, she is having a problem with balance and dragging her right leg. Patient also mentioned that she also felt foggy. Patient would like to know if these are common side effects. Patient would also like to know how long the symptoms will last. Patient also stated that she has an appointment tomorrow with her HCP and she will be unable to drive in the current state she is in and will have someone else drive her to the appointment. It was also reported that patient was calling on the line calling about the Corona shot and clarified it to be the Pfizer COVID Vaccine. Patient initially stated she received her first dose around 2'oclock yesterday (18Jan2021). Patient mentioned that she is having a reaction that she does not see on the list. Patient received the injection in her left arm and her left arm feels funny which is to be expected, but her right leg is dragging. Patient also reported that her balance was off which it never was. Patient added that she also felt foggy. Patient was calling to see if this was a side effect and if it is, when will it go away. She started to notice her right leg dragging this morning around 7:30 am on 19Jan2021. She thought it would go away. Around this same time she noticed her balance was off. She has to walk very slowly. As she walks by she has to touch the wall and that is not like her at all. She is normally very active. Normally she walks for an hour as an active person. This feeling is not like her. She started to feel foggy this morning when she woke up. Patient clarified that time of vaccination was 2:30 pm. Vaccination facility type was reported as hospital. The events were assessed as non-serious. Outcome of the event 'her arm started to feel funny. Patient stated it was not painful but felt numb' was unknown, outcome of the remaining events was not recovered.
77 2021-02-01 pain in extremity Short lived but I thought you should be advised. Heavy feeling in legs starting around 4.5 hours a... Read more
Short lived but I thought you should be advised. Heavy feeling in legs starting around 4.5 hours after shot, lasted for approximately 24 hours. Also arm felt sorer that on first show. Now feeling fine
77 2021-02-03 weakness Chills; low grade fever 99.4 orally; fatigue; weakness; This is a spontaneous report from a contacta... Read more
Chills; low grade fever 99.4 orally; fatigue; weakness; This is a spontaneous report from a contactable Physician. A 77-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose (2nd dose) for covid-19 immunization. Medical history included high cholesterol and has no known allergies. The patient's concomitant medications were not reported. The patient had her first dose on left arm of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot no. EJ1685) at 12:00 on 22Dec2020 but had slight discomfort site injection and occasional soreness site injection over the subsequent 3 weeks. For vaccine dose 2, it was reported that after 30-36 hr, patient developed chills, low grade fever 99.4 orally, fatigue, weakness and took ibuprofen. She slept normal by 42 hrs and no further complications. The outcome of events recovered on unspecified date. The facility where the most recent COVID-19 vaccine was administered was in a school clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information about lot/batch number has been requested.
77 2021-02-03 difficulty speaking Received injection at 0900, at 0910 began feeling sensation of itchy throat. By 0930, increased with... Read more
Received injection at 0900, at 0910 began feeling sensation of itchy throat. By 0930, increased with raspy voice and urge to cough. Took at approx. 10am. By 1030 itchy throat mildly decreased but with dizziness and chills. O2 sat was 98%. By 1200 most symptoms resolved. At 1400 again with increased itchy throat so took 25mg of Benadryl. No other symptoms, O2 sat 96% and heart rate in the 80's.
77 2021-02-03 muscle spasms Itching/She was itching on her knee, leg, arm, neck, and ears.; She had hives on the knee; The two t... Read more
Itching/She was itching on her knee, leg, arm, neck, and ears.; She had hives on the knee; The two that had her most worried was the memory loss and chest pain; Chest pain; It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street; Spasms/spasms were like in her back where her shoulders were and it was bulging; It hurt from her neck and up into her head.; It hurt from her neck and up into her head.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3246, expiration date unspecified), via an unspecified route of administration on 10Jan2021 (around noon) at single dose (left arm) for COVID-19 immunization. Medical history included ongoing diabetes, ongoing blood pressure high/blood pressure, ongoing heart problems; heart disease, kidney disease, history of itching, fluid (imbalance), stroke so taking for clotting, history of neck issues and she was allergic to a lot of medications. Ongoing concomitant medications included ubidecarenone (COQ-10), zinc, torsemide for fluid, clopidogrel for had a stroke so taking for clotting, insulin glargine (LANTUS) for diabetes and isosorbide mononitrate, carvedilol, irbesartan and amlodipine, all for blood pressure. Patient reported that she got the injection on Sunday and then later she started to get spasms on 12Jan2021. These spasms were like in her back where her shoulders were and it was bulging and it hurt from her neck and up into her head. She mentioned she was 77 years old and sometimes she has to think about a word before she gets it out, but yesterday (14Jan2021) it was different. It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street on and this lasted 15 minutes and then it went away. She confirmed she does not have it right now. It did not last a long time, but it scared her so bad. Then yesterday evening (14Jan2021), she started to have funny chest pain. She told her husband if it did not go away she would go to the ER. However, after an 1 hour it went away. It was like a sticking pain. The chest pain lasted for an hour and started around 18:00. On an unspecified date, she started itching at night. She has a history of itching, but this was out the box. She had hives on the knee. It was crazy. She itched all over. She had to get out of bed and sit in a chair until 1:30AM. She was still itching, but it was not as bad. Patient reported that due to the kidney disease she has itching, but the itching she was having after this COVID Vaccine was different and more. It was out of the box. She confirmed this was the first injection and now she was scared to get the second injection. Patient reported that the itching started when she went to bed. She went to bed around 21:00 and around 21:30, she got out of bed because she was itching so bad. She stated there was not anything different on the bed. It was the same thing that was up there the night before. She did not change the sheets or anything. She had to get up and sit in a chair and she could not believe how bad her knee was itching. She was itching on her knee, leg, arm, neck, and ears. She stated she takes a lot of medications. She was very funny with medications and they have to work with her to get the right one for her. Due to having these other conditions was why she wanted to get the COVID Vaccine. She reported she will have her blood drawn next week. The two that had her most worried was the memory loss and chest pain. However, these passed and she did not go the ER or physician office. She was afraid if she gets the second injection this will happen again and she may not come out as well form it. Prior vaccinations within 4 weeks was none. Outcome of events spasms/spasms were like in her back where her shoulders were and it was bulging and itching/itching on her knee, leg, arm, neck, and ears was recovering; chest pain was recovered on 14Jan2021 at 19:00; and outcome of the rest of events was unknown.
77 2021-02-03 pain in extremity head started to spin when she put her head down on the pillow; dizzy /light headed, passed until she... Read more
head started to spin when she put her head down on the pillow; dizzy /light headed, passed until she went to sit up and get out of bed/ Her head feels like it is swimming mostly when she gets in and out of bed. When she lays her head down and picks her head up; foggy headed/ floaty heady feeling/ she puts her head down, it is like woah this is strange; arm tenderness that lasted for 24-36 hours/ arm was a little sore/ little achiness in her arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for 2 patients. This is the first of 2 reports. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248, Expiration date: 30Apr2021), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The vaccine was administered in a hospital. The patient is taking medication for ongoing blood pressure and ongoing thyroid. Ongoing concomitant medication included metoprolol succinate for blood pressure and levothyroxine sodium (SYNTHROID) for thyroid. She received the vaccine on Saturday 16Jan2021. It went very well. On 16Jan2021, she had a little bit of arm tenderness that lasted for 24-36 hours. Her arm was a little sore. The odd thing is that something took place when she got into bed on Sunday night 17Jan2021 which was 30 hours after the vaccine. Her head started to spin when she put her head down on the pillow. She was very dizzy. She was light headed/ foggy headed. That passed until she went to sit up and get out of bed. It happened again. It has been happening on and off for the last 3 days. She has checked her blood pressure because she is on a low dose blood pressure medicine. Her blood pressure was okay. Everything else seems to be normal. She gets that dizziness for a very short period of time. Her head is not a headache. It is so hard to explain. It is like a floaty heady feeling. She did have a little achiness in her arm. When she puts her head down, it is like woah this is strange. Her head feels like it is swimming. It is mostly when she gets in and out of bed. When she lays her head down and picks her head up. She provided that her height as 5'1" to 5'1.5". The event arm tenderness that lasted for 24-36 hours/ arm was a little sore/ little achiness in her arm recovered on 18Jan2021; outcome for all other events was not recovered.; Sender's Comments: Linked Report(s) same reporter/drug, similar event, different patient
77 2021-02-06 feeling cold About 12 hours after receiving my booster vaccine I started feeling chills, then fever and extreme m... Read more
About 12 hours after receiving my booster vaccine I started feeling chills, then fever and extreme muscle aches and headache. My fever lasted about 12 hours running between 100 and 102 (on tylenol) Headache continues. Muscle aches and fever subsided about 24 hours after onset.
77 2021-02-06 pain in extremity Sore arm started in the middle of the night--still sore two days later. General achiness all over. ... Read more
Sore arm started in the middle of the night--still sore two days later. General achiness all over. General tiredness.
77 2021-02-07 pain in extremity, tingling, numbness soreness in right arm; numbness in right hand; tingling in right foot; This is a spontaneous report ... Read more
soreness in right arm; numbness in right hand; tingling in right foot; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/lot number: EL9262), via an unspecified route of administration in the right upper arm on 20Jan2021 at single dose for covid-19 immunisation. The patient medical history included ongoing diabetes. Concomitant medications were not reported. The patient experienced soreness in right arm, numbness in right hand and tingling in right foot on 22Jan2021 with outcome of not recovered. She was schedule for the second dose on 10Feb2021.
77 2021-02-07 pain in extremity sore arm, chills and exhaustion so bad came close to being nauseous. All in first 24 hrs. Was fin... Read more
sore arm, chills and exhaustion so bad came close to being nauseous. All in first 24 hrs. Was fine 24 hrs later
77 2021-02-07 pain in extremity arm pain; itching; It's become difficult to move her arm and has worsened since the injection/ I had... Read more
arm pain; itching; It's become difficult to move her arm and has worsened since the injection/ I had a hard time lift my arm in changing clothes; It's become difficult to move her arm and has worsened since the injection/ I had a hard time lift my arm in changing clothes; I feel in my arm, around that shot you know I had the injection, start itchy start feel itchy; my arm feel pink, it's swell up and it's scratch; my arm feel pink, it's swell up and it's scratch; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included bone disorder (reported as bad bone problem). Concomitant medication included denosumab (PROLIA) for bone disorder. The patient received her first injection on 09Jan2021 and had been experiencing arm pain which was mild to moderate but about a week later she developed itching in the same arm. It's become difficult to move her arm and had worsened since the injection. She wanted to know if this type of experience had been reported and if she should receive the second vaccination scheduled for the 30th. The patient stated that she had a hard time lift my arm in changing clothes and she can't her shoulder. After one week later about almost 1 week later she felt in her arm, around that shot she had the injection, started itchy started to feel itchy and she was afraid maybe infection, dead skin, maybe infection or something. She showed it to her friend, saying "Look my arm feel pink, it's swell up and it's scratch, it's itchy." Clinical outcome of event "difficulty to move her arm and had worsened since the injection" was not recovered while for the other events was unknown.
77 2021-02-07 paralysis Note:Tested positive to CV19 27th October 2020 Pharmacy. CV19 Symptoms: High fever and fatigue. No... Read more
Note:Tested positive to CV19 27th October 2020 Pharmacy. CV19 Symptoms: High fever and fatigue. No loss sense of taste and/or smell. No breathing problems. 5th February 2021 Pfizer 1st dose CV19 vaccine. Scary symptoms started in grocery store parking lot around 6PM (after vaccine at 8:35A) my legs felt like they were partially paralyzed and I would not be able to walk to the car. I struggled to walk. Got home and laid down. Thought it was side effects to vaccine and it would pass if I went to sleep. Woke up and felt totally paralyzed and it required a lot of effort to turn on my side to try to reach my phone. All my muscles and joints ached. I am never sick and not a complainer.
77 2021-02-08 weakness Severe all over muscle and joint ache, fatigue, dry cough, chills, dizziness and weakness. Began ar... Read more
Severe all over muscle and joint ache, fatigue, dry cough, chills, dizziness and weakness. Began around 7 or 8 am February 5 and continued all day and evening. I slept most of the day. Around 11:30 that night I woke up feeling quite a bit better. I slept all night. The next morning, Saturday, the aches had gone away and I was alot better. The cough, however, continued. The cough continued through Sunday. Monday the cough happened only a few times and I felt energetic and completely back to normal.
77 2021-02-08 tremor diabetic; sugar level went to 66; shaking; dizziness; fatigue; This is a spontaneous report from a c... Read more
diabetic; sugar level went to 66; shaking; dizziness; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK9231), via an unspecified route of administration, on 23Jan2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history included drug allergy (to epinephrine), diabetes, chronic obstructive pulmonary disease (COPD), arthritis. Patient did not have COVID-19 prior to vaccination. Concomitant medications included glipizide (unknown manufacturer), losartan (unknown manufacturer), lovastatin (unknown manufacturer), metformin hydrochloride (MEDFORMIN), meloxicam (unknown manufacturer). The patient experienced diabetic, sugar level went to 66, shaking, dizziness and fatigue all on 24Jan2021 at 11:00 with outcome of not recovered. The patient underwent lab tests and procedures which included blood glucose: 66 on 24Jan2021, 88 on 24Jan2021, 360 on 24Jan2021, 186 on 25Jan2021. On 24Jan2021 it was reported that sugar level went to 66. She ate sugar, level went to 88, ate more sugar level went to 360. Therapeutic measures were taken as a result of diabetic and sugar level went to 66 and included sugar. No therapeutic measures were taken as a result of the other events. Patient was not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.
77 2021-02-09 feeling cold By the time 24 hours passed, I felt fine. Around 1:00 the following day I began to feel generally s... Read more
By the time 24 hours passed, I felt fine. Around 1:00 the following day I began to feel generally sick. I felt tired, headachy, nauseous. I rested and felt worse and worse. I soon began chilling -- couldn't get warm. After a couple hours, I took my temp and it registered 101.1. I went to bed feeling quite unwell. When I awoke the next morning, I felt pretty good and felt fine all the next day.
77 2021-02-09 pain in extremity muscle in the right arm started to hurt.; This is a spontaneous report from a contactable consumer (... Read more
muscle in the right arm started to hurt.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL8982) via an unspecified route of administration in right arm on 23Jan2021 09:00 at single dose for COVID-19. Medical history included rotator cuff surgery on her left arm on 28Dec2020 that was affected by a flu shot that she just got (sore left arm Flu vaccine, 26Oct2019-27Oct2019), chronic lymphocytic leukaemia (CLL) (had it 20-25 years ago stated that she watches her white blood cell count on it). Family medical history relevant to AE was none. No vaccine was received within four weeks. There were no concomitant medications. The patient experienced muscle in the right arm started to hurt on 24Jan2021 17:00. She put ice on it as treatment. Relevant tests were none. The event didn't require Emergency Room visit or Physician Office visit. The outcome of event was not recovered.
77 2021-02-10 weakness Pain in the jaw, neck, throat, bilateral lymph pain/swelling, sweating, chills, weakness - neck pain... Read more
Pain in the jaw, neck, throat, bilateral lymph pain/swelling, sweating, chills, weakness - neck pain, swelling, lymphadenopathy persist now Taking acetaminophen. At home for now. Also adv warm compresses/drinks for comfort. Adv to FU with HCF trouble breathing or if symptoms persist/worsen.
77 2021-02-10 feeling of body temperature change, weakness dont want to eat anything; hot and cold chills; headaches; muscle pain; fever; joint pain; injection... Read more
dont want to eat anything; hot and cold chills; headaches; muscle pain; fever; joint pain; injection site swelling; redness; nauseated; swollen lymph nodes on throat; face swelling; fast heartbeat; body didn't feel well; chills; didn't feel like herself; light headed; felt weak; tired/slept all day; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 22Jan2021 15:30 at a single dose on right arm for COVID-19 immunization. Medical history included breast cancer 16 years ago, patient on defibrillator from Oct2016 (it was reported that this past October2020 would have been 4 years since she had the defibrillator put in), ongoing congestive heart failure, ongoing (COPD) chronic obstructive pulmonary disease, sinuses problems, back and hip problems, positive for COVID-19 from 11Jan2021, and hurting. The patient's concomitant medications were not reported. The patient previously received flu shot for immunization on unspecified date. On Saturday (23Jan2021), the patient reported that she "slept all day, felt weak, light-headed, and tired". The patient stated, "I have problems breathing anyways". The patient stated she "doesn't want to eat anything". On Sunday (24Jan2021), the patient "felt good", then Monday (25Jan2021), "didn't feel too bad". On unspecified date, patient experienced hot and cold chills, body didn't feel well, and breathing problems. She has breathing problems because she has COPD. Other things in the list of the adverse events (from the paperwork she was given) that the patient experienced include tiredness, headaches, muscle pain, chills, fever, joint pain, injection site swelling, redness, nauseated, feeling unwell, swollen lymph nodes on throat, face swelling, a fast heartbeat, dizziness, and weakness. Right now (26Jan2021), the patient did not even feel like going to her doctor's appointment (on Thursday). She just didn't feel like doing anything. She didn't feel like herself on 26Jan2021. She clarified on 11Jan2021 (prior to vaccination), she went to hospital because she was hurting. She clarified it was in and out of the Emergency Room. She was never admitted into the hospital. They ran some tests urine, blood, EKG tests. All the tests came back good. The patient underwent COVID test on 11Jan2021: positive; and same test on 22Jan2021: negative. Outcome of the events was unknown. Information about lot/batch number has been requested.
77 2021-02-10 pain in extremity My blood pressure was a little elevated, high for me / elevated blood pressure; Arm sore; This is a ... Read more
My blood pressure was a little elevated, high for me / elevated blood pressure; Arm sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FL3246, expiry date not reported), via an unspecified route of administration in the left arm on 23Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing thyroid disorder. Concomitant medication included hctz. The patient experienced that her blood pressure was a little elevated, high for her/elevated blood pressure on an unspecified date. On 25Jan2021, the patient experienced arm sore. The patient underwent lab tests and procedures which included blood pressure measurement: 160/88 on an unspecified date, blood pressure measurement: normal (reported as normally around 130, 135, 138, normally runs 140/35-38), heart rate: 85 on an unspecified date, laboratory test: unknown result on an unspecified date. Clinical outcome of arm sore was recovering, while for blood pressure increased was unknown.
77 2021-02-10 tremor, feeling hot chills, shakiness followed by feeling very warm, sweating and sweaty, Extreme fatigue, body aches, j... Read more
chills, shakiness followed by feeling very warm, sweating and sweaty, Extreme fatigue, body aches, joint pain. Injection site pain. Muscle pain. Nausea--did throw up twice. General feeling unwell. The fatigue has gone on for two weeks now. Starting to get better.
77 2021-02-11 weakness DIZZINESS,,,,, HEADACHE UNRELIEVED WITH TYLENOL, GENERALIZED ACHINESS, WEAKNESS,SPO2 L0W 90%
77 2021-02-11 burning sensation Patient received 1st dose of Pfizer Covid19 vaccine today at the Health Department at approx 10:56 A... Read more
Patient received 1st dose of Pfizer Covid19 vaccine today at the Health Department at approx 10:56 AM; pfizer lot number EN5318. Patient has history of feeling 'flushed' after paxil, sulfa, flexeril, codeine; no history of anaphylaxis. Patient alerted the guardsman at 11:09AM that she was experiencing swelling and burning on her face and lips. Nursing and medic staff responded and observed swelling over her right eye and cheek. The medic reported a significant increase in swelling from her pre-vaccinated appearance. BP 118/76. EMS already on site. Epi 0.5mg 0.5ml (Lot 339384) administered RD IM and Benadryl 50mg IM LD administered at 11:11 AM. EMS called for 2nd transport vehicle and arrived at 11:23AM and assumed care of patient. Patient transported to hospital. Called patient on 2/11/2021. Patient stated feeling better. Stayed at hospital and was observed for 4 hours. IV and oral Prednisone given. Still has some facial swelling. PCP recommends not getting second dose.
77 2021-02-12 pain in extremity One hour after receiving the vaccination, I had an uncontrolable bout of diarrhea in a public place.... Read more
One hour after receiving the vaccination, I had an uncontrolable bout of diarrhea in a public place. Later in the day, I felt fatigued, and aching, and my left arm started to get very tight and sore. The next day I felt the same, and my lymph nodes under both my arms began to swell and hurt and my rectum began to have severe pain. Still had diarrhea. By day 5 my left arm ,at the site of the injection ,started to swell, get very hot ,and a large, bright red welt appeared which almost reached my elbow and went across the width of my upper arm.. I called my doctor and went to see her on the next day because it had gotten worse. She thought it was a local reaction and recommended ice, tylenol and benedryl. Again, as with the first shot, I am not sure if this is an allergic reaction or not., but thought I would report it.
77 2021-02-13 tremor Chills, vomiting, diarrhea, sweats, tremors, dizzy, headache, unsteady gait, fever 101. Symptoms las... Read more
Chills, vomiting, diarrhea, sweats, tremors, dizzy, headache, unsteady gait, fever 101. Symptoms lasted for 24 hours and then I was feeling bad and in bed for 3 days. I took Tylenol for symptoms. I called my doctor and was advised to take Tylenol.
77 2021-02-14 weakness, feeling hot, flushing Covid dose #2 (Lot EN6201) given at 1:19pm. Pt began feeling flushed, hot, and weak at approximatel... Read more
Covid dose #2 (Lot EN6201) given at 1:19pm. Pt began feeling flushed, hot, and weak at approximately 1:30pm. She was able to walk into Triage under her own power. BP was 190s/90s upon arrival to traige. Pt pale and complained of feeling lightheaded and that she felt like she was going to pass out. 400ml of orange juice given since patient stated that she had not eaten since 8am. Blood sugar taken 15 minutes after resulted at 116. Multiple blood pressures taken resulted in consistent 190s/90s. 911 called by provider at 2:07pm. Fire Department arrived on scene at 2:13pm. EMS arrived on scene at 2:16pm. Vitals taken by EMS and it was determined that since her blood pressure continued to be elevated similar as prior and she felt unable to stand under her own power to take her to Emergency Department. EMS left the clinic at 2:30pm. Pt had all belonging with her and her family had been notified. She remained conscious and able to answer questions throughout the event.
77 2021-02-14 migraine She had Pain: Headache or Migraine after the vaccine. Onsite EMS was requested.BP 142/86 HR 86 99% ... Read more
She had Pain: Headache or Migraine after the vaccine. Onsite EMS was requested.BP 142/86 HR 86 99% O2 on room air. They were able to find a specific cause and she refused additional workup
77 2021-02-15 flushing Patient tolerated her first dose of the COVID19 vaccine well, but her second dose on 02/12/2021 was ... Read more
Patient tolerated her first dose of the COVID19 vaccine well, but her second dose on 02/12/2021 was not tolerated as well. Patient experienced 4 days of a low-grade fever, fatigue, facial flushing, injection site pain, and itching of the upper arm with little relief from OTC ibuprofen. Recommended OTC acetaminophen and a follow-up appointment with her PCP.
77 2021-02-16 tremor Extreme shaking and chills, large lump appeared on left leg thigh, Pressure of top of head (left s... Read more
Extreme shaking and chills, large lump appeared on left leg thigh, Pressure of top of head (left side) and painful throbbing on right side of neck.
77 2021-02-16 unresponsive to stimuli, pain in extremity Patient had COVID in Sept. Minimal symptoms. Received 1st dose 1/18 without adverse reactions. Se... Read more
Patient had COVID in Sept. Minimal symptoms. Received 1st dose 1/18 without adverse reactions. Second dose on 2/8-had complaints of arm soreness several days after then appeared in usual state of health. On 2/14 @ 2 hours after having lunch, patient was found unresponsive with Respirations 60, pulse 130, PO 84%, blood pressure 105/68. Patient with lots of white foam coming out of mouth. Temperature to 101.3. Patient DNR B and family deferred transfer, wanted comfort measures only. Nursing received order for MSIR. Patient continued with temps in 99-100 range with tylenol suppositories. Patient passed on 2/16.
77 2021-02-17 discomfort Severe virtigo and intractable nausea requiring ER admission. Sxs ameliorated with Ativan, meclizine... Read more
Severe virtigo and intractable nausea requiring ER admission. Sxs ameliorated with Ativan, meclizine, Metachlopramide in ER. Persistent sxs of virtigo, decrease hearing, nausea resolving over several days treated with meclizine, ativan, phenergan, Virtigo improved but still persisting when moving quickly or looking up or down Left frontal discomfort and sinus congestion; hearing returned to near baseline after 10d Steroid 5d dose pack and Augmentin started 2/13 Still unsteady (untrustworthy gait), excess fatigue and fatigability, wt loss, head pain Has not had fever
77 2021-02-17 pain in extremity Sore left arm from 2/16/2021 thru 02/18/2021. Extreme fatigue and tiredness from 02/17/2021 thru 0... Read more
Sore left arm from 2/16/2021 thru 02/18/2021. Extreme fatigue and tiredness from 02/17/2021 thru 02/18/2021
77 2021-02-18 flushing, feeling hot, weakness 77yo 69kg F received dose #2 COVID-19 vaccine. PMH significant only for basal cell carcinoma. Allrgy... Read more
77yo 69kg F received dose #2 COVID-19 vaccine. PMH significant only for basal cell carcinoma. Allrgy hisotry includes adhesive, ciprofloxacin, ibuprofen (swelling), meloxicam (swelling) . Approx 10 min after vaccination pt reported feeling flushed, hot, and weak at approximately 1:30pm. She was able to walk into Triage under her own power. BP was 190s/90s upon arrival to traige. Pt pale and complained of feeling lightheaded and that she felt like she was going to pass out. 400ml of orange juice given since patient stated that she had not eaten since 8am. Blood sugar taken 15 minutes after resulted at 116. Multiple blood pressures taken resulted in consistent 190s/90s. 911 called by provider at 2:07pm. Fire Department arrived on scene at 2:13pm. EMS arrived on scene at 2:16pm. Vitals taken by EMS and it was determined that since her blood pressure continued to be elevated similar as prior and she felt unable to stand under her own power to take her to Emergency Department. EMS left the clinic at 2:30pm. She remained conscious and able to answer questions throughout the event. BP in ED 162/89. Pt with no prior hx hypertension. Elevated BPS thought possibly due to "white coat hypertension". In ED pt received diazepam 2.5mg po x1. She returned to baseline and was able to be discharged a few hours later at 1742.
77 2021-02-18 numbness, tingling Immediate blurred vision, numbness in extremities, loss of balance within 1 minute. Confusion of sur... Read more
Immediate blurred vision, numbness in extremities, loss of balance within 1 minute. Confusion of surroundings. Tingling in fingers and feet. Swollen tongue within an hour. No sense of time or place. these last about 30 hours.
77 2021-02-19 weakness Very low energy upon waking on morning after the vaccine. Lasted all day. Felt feverish but no fever... Read more
Very low energy upon waking on morning after the vaccine. Lasted all day. Felt feverish but no fever. Slept most of day until late afternoon when I finally took 2 aspirin. Injection site tenderness.
77 2021-02-19 flushing Patient face was flush. Noticed by family after the 15 min observation. Pt had no DIB or other com... Read more
Patient face was flush. Noticed by family after the 15 min observation. Pt had no DIB or other complaints. Pts BP was high and has a history of hypertension. Unknown if this was caused by the vaccine or the patients preexisting health conditions. Pt was transported to hospital by ambulance.
77 2021-02-21 weakness chills; slight headache; joints aching; muscles aching; fatigue; weakness; This is a spontaneous rep... Read more
chills; slight headache; joints aching; muscles aching; fatigue; weakness; This is a spontaneous report from a contactable healthcare professional. A 77-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 06Feb2021 14:00 at a single dose for covid-19 immunization. The patient medical history was reported as none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included bupropion, levothyroxine, sumatriptan succinate (IMITREX) and vitamin nos (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3246) at the age of 77-year-old via an unspecified route of administration right arm on 16Jan2021 14:00 at a single dose for covid-19 immunization. On 07Feb2021 11:00 PM (reported as 33 hours post [23:00] second vaccination), the patient had chills, slight headache, joints aching, muscles aching, fatigue and weakness. The patient has not been tested for COVID-19 since the vaccination. The events were non-serious, and the patient did not received treatment for the adverse events. The outcome of the events was recovered on Feb2021.
77 2021-02-21 numbness patient c/o lightheadness at 11:55am. Blood pressure was 142/90. Consulted with Doctor. observed ... Read more
patient c/o lightheadness at 11:55am. Blood pressure was 142/90. Consulted with Doctor. observed for 10 more minutes. Patient started c/o numbness in face, shortness of breath and chest pain around 12:05pm. 02 was 99%. Consulted with Doctor and paramedics called. Patient was confused and had difficulty with balance while being transferred to ambulance. Transported to medical Center at 12:18pm
77 2021-02-21 pain in extremity on 2/11/2021 AT 5:30pm Evening of the vaccination, my neck aching, and slight headache, When I woke... Read more
on 2/11/2021 AT 5:30pm Evening of the vaccination, my neck aching, and slight headache, When I woke the next day my arms and legs and neck and head ached, like I was coming down with a flu bug. Slight headache, Lymph nodes in neck painful and sore, legs and arms aching, flu like symptoms
77 2021-02-21 tingling, numbness, face paralysis Tingling and numbness in face, could not move face, resolved after a day
77 2021-02-23 weakness, tremor At 15 Minutes: Dizzy, felt like head exploded, heart pounding, BP over 200 for a short time, taken t... Read more
At 15 Minutes: Dizzy, felt like head exploded, heart pounding, BP over 200 for a short time, taken to a room for observation, after about 30 minutes taken to Prompt Care Facility on premesis. Had slight nausea, shakiness, weakness, little dizzy, headache. Treatment: observation, asking questions, checking vital signs, checked Glucose: Normal. Stayed at Clinic approx. 1 Hour. Considered going to ER but continued to feel better as time passed and went home. BP was at 167/66 when leaving. Later same evening 10:30 p.m. at home: BP at 136/72/66, Next day 2/21/2021 BP at 128/70/63. 2/22/2021 BP 123/66/61. Continue to have headaches.
77 2021-02-23 weakness Severe Diarrhea, vomiting, nausea, Severe weakness, Chills. Put on Ondansetron, the BRAT diet, and ... Read more
Severe Diarrhea, vomiting, nausea, Severe weakness, Chills. Put on Ondansetron, the BRAT diet, and Pedialyte. Vomiting lasted 2 days, Nausea lasted 5 days, Diarrhea lasted off and on for 14 days, weakness lessened by lasted for 12 days, chills lasted for 14 days
77 2021-02-23 feeling cold 2/19/21 12:30 AM- slight headache, followed by chills and body ache-especially lower bac. Last unti... Read more
2/19/21 12:30 AM- slight headache, followed by chills and body ache-especially lower bac. Last until about 4 PM 2/19/21 2/19/21 2:00 AM - discomfort chest/heart- Thought maybe I should mention it to doc if continued. Lasted 20 min. max. 2/19/21 12:30 AM-lower abdominal discomfort, bowel movement did not relieve discomfort - intermittent for several days until 2/23/21. Did not interfere with activities. Since symptoms were mild, I "toughed" it out. No medication
77 2021-02-23 feeling hot PATIENT BEGAN TO FEEL HOT AND SWEATY POST VACCINE
77 2021-02-23 unresponsive to stimuli the patient had hypoxemia the evening of the shot, and then was found unresponsive the next morning,... Read more
the patient had hypoxemia the evening of the shot, and then was found unresponsive the next morning, in cardiac arrest at home. Temperature on arrival to ED was 91 degrees. found to have severe anoxic brain injury after 60+ minutes of CPR. may already be brain dead.
77 2021-02-24 numbness Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All 2/2... Read more
Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All 2/25/2021 Date: 2/25/2021 Subjective a 77 y.o. female who was seen at Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience L hand numbness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. PMH includes DM, HTN, asthma. Takes metformin and losartan around noon every day. She has not taken her bp medication yet today as she takes it with lunch. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/25/21 1145 02/25/21 1201 BP: (!) 160/97 124/83 Pulse: 72 SpO2: 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No cranial nerve deficit or facial asymmetry. Sensory: Sensation is intact. No sensory deficit. Coordination: Coordination is intact. Gait: Gait abnormal (walks with walker, steady gait). Comments: +5/5 strength against resistance to both upper and lower extremities. Assessment/Plan Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Exam is stable/unremarkable. VS improved. Pt monitored for 20 minutes. She feels well. Possible more likely anxiety related than a local reaction. Pt aware to monitor and follow up with pcp if needed. Pt here with husband whom walked out with her. She declined wheelchair. She feels well. APRN Electronically Signed 2/25/2021 11:59 AM
77 2021-02-25 feeling jittery, muscle twitching, pain in extremity Felt jumpy on the injection site/right arm started jumping/"been jumping, jumpin jumpin jumpin", a m... Read more
Felt jumpy on the injection site/right arm started jumping/"been jumping, jumpin jumpin jumpin", a muscle twitch; Felt jumpy on the injection site/right arm started jumping/"been jumping, jumpin jumpin jumpin", a muscle twitch; Arm is sore; Heart is pounding; I'm a little jittery. I am very nervous; I'm a little jittery. I am very nervous; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the right arm on 27Jan2021 (10:00) at a single dose for COVID-19 immunization at the school/student health clinic. Medical history included diabetes diagnosed about 12 years ago; high blood pressure diagnosed about 30 or 40 years ago; and weight loss. Concomitant medication included insulin (INSULIN) for diabetes. The patient previously took influenza vaccine, sitagliptin phosphate (JANUVIA) and tramadol (ZALDIAR); and had rash on both medications. The patient had previously received a flu shot around the 6th or 7th of Dec2020. On 27Jan2021, at "about 4PM", the patient had felt jumpy on the injection site/right arm started jumping; it had "been jumping, jumpin jumpin jumpin, a muscle twitch". Also on 27Jan2021, at "about 4PM", the patient's arm was sore; heart was pounding; was a little jittery; and was very nervous. The outcome of the events, 'felt jumpy on the injection site/right arm started jumping', 'had "been jumping, jumpin jumpin jumpin, a muscle twitch"', 'arm was sore', 'heart was pounding', 'little jittery' and 'very nervous', was unknown.
77 2021-02-25 flushing Notified by patient that she had "an allergic reaction" to her first dose of the vaccine. "It happen... Read more
Notified by patient that she had "an allergic reaction" to her first dose of the vaccine. "It happened a day later, but I don't know if it was the shrimp I had that day. I was flushed and I got welts, so I went to the urgent care. I was prescribed an Epi-pen by my allergist after following up with them. I feel comfortable getting the second dose." Pharmacist and vaccine clinic lead notified. 30 min after dose given, pt states, "My ears are feeling a little itchy." Vital signs @ 1002: BP 175/80 P 69 O2 97% Temp 98.3 F R 12. VS @ 1007: BP 165/79 P 64 O2 98% Temp 98.4 F R 14. 1015 Pt states, "I'm feeling better and my husband is at home to watch me. I think I was just nervous." Pt declines dizziness/lightheadedness upon standing and declines any itching after second set of VS. Educated pt on strict ER precautions. Pt verbalized understanding and was appreciative for visit.
77 2021-02-26 pain in extremity, tremor, night sweats Shaking, chills, fever (101), headache, slight nausea, arm pain. Took Tylenol. Night sweat the f... Read more
Shaking, chills, fever (101), headache, slight nausea, arm pain. Took Tylenol. Night sweat the following night. Event lasted 24 hours. Fine the following day, 2/27/21.
77 2021-02-26 tingling LEFT ARM TINGLING AND ITCHING
77 2021-02-28 weakness patient felt extreme fatigue and weakness -- trouble in moving and getting to bed-- layed down for 3... Read more
patient felt extreme fatigue and weakness -- trouble in moving and getting to bed-- layed down for 30 min and improved after 30 minutes
77 2021-02-28 weakness Started with chills, fever. Next morning could hardly get out of bed. Very weak and throwing up bla... Read more
Started with chills, fever. Next morning could hardly get out of bed. Very weak and throwing up black liquid. Could not take care of self for 2 and one-half days. Very weak for 4 days. I was sick with the 1st vaccine for a day one-half with chills and fever but nothing compared to the 2nd one. I will not taken another Pfizer vaccine ever.
77 2021-02-28 weakness Awakened from sleep, extremely cold, teeth chattering and shivering at 02:30 Returned to bed covere... Read more
Awakened from sleep, extremely cold, teeth chattering and shivering at 02:30 Returned to bed covered up with more blankets. Upon wakening, felt felt totally exhausted and weak. I slept and took naps throughout the day. Some aches in the body and sore arm where injection was given. Continued to feel extremely weak and cold the next 24 hours. Felt better day after but still tired and weak. injectgion site reddened and sore. Injetion site still sensitive, rpink discoloration and lump under the skin
77 2021-02-28 tremor, feeling cold, weakness Blinding headache/ severe headache; chills/ shivers; couldn't warm up; Whole body was shaking out of... Read more
Blinding headache/ severe headache; chills/ shivers; couldn't warm up; Whole body was shaking out of control/ She got the shakes so bad she shook for like 5 hours; Neck froze completely; She can't move her head up and down normal/ couldn't move her head; Pain in her neck; pulled muscles; Muscles were so sore; Fatigue/Extreme tiredness; Weakness; Muscle pain; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL0140), via an unspecified route of administration at the right arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient had anaphylactic shock in the past to a sulfur antibiotic. There were no concomitant medications. She stated she did not have an extreme reaction for the first 3-4 days, it was fine and went away. She had fatigue, joint pain, all the regular things and they were easing up. She had an appointment on the 20Jan2021 and thought things were going okay. On day 7, 20Jan2021, that night, she had an extreme reaction of blinding headache, the shakes, her whole body was shaking out of control for hours, her neck froze completely, and she can't move her head up and down normal (this is still occurring). The patient has had joint paint on 14Jan2021; extreme tiredness, weakness and muscle pain on 15Jan2021; chills, pain in her neck and muscles were so sore from 20Jan2021. She figured that was side effects, and she was handling, and then exactly a week after, she got the shakes so bad she shook for like 5 hours, she had to put nightguard in her mouth to stop from cracking, and severe headaches and her neck completely locked up, she couldn't move her head, and she still can't. She had extreme headache, and she went to the ER on 26Jan2021, since she was in really bad shape, they wouldn't believe her that it was a COVID reaction, she was there for 12 hours, they did every test, she had spinal taps, she had a head X-ray, everything, as they said she had meningitis, but then ruled that out, they wouldn't believe she was having a reaction to the COVID shot, she can't move her head, her joints and that are ok otherwise, but she can't move her head, she has pain in her neck, and she is taking Excedrin for that. She stated her doctor told her to go ahead and take the second dose of the vaccine and just take Tylenol after. She stated Tylenol has no effect whatsoever. If she takes Excedrin the headache will go away and Tylenol won't budge it. She stated she is taking Excedrin regardless of what the doctor says. When asked for age of onset, states she was on Valium and she was not thinking straight, and asked her husband her age. She was not sure why it was given, now provides name as Diazepam 5mg. Muscle pain is fine now, it went away. She went to the doctor on 20Jan2021, as she had a regular appointment for bloodwork to be done, and said she felt pretty good, she had some reaction but was fine, and that night is when she got shakes and shivers so bad, she had 3 quilts on and couldn't warm up, her body was out of control, she couldn't stop, now states for 3-4 hours. Severe headaches started the night of the 20Jan2021. Her neck pain started right after the shakes, so maybe she pulled muscles when she had the shakes, the muscles were so sore, and she couldn't move her head, like down or to the side, she couldn't move it, which is why she went to the hospital, to the ER. She was there for 12 hours. She started taking Excedrin, states she ignored what the doctor told her. She knows her body and she can take Tylenol and Ibuprofen like it is candy, and it does nothing, one Excedrin puts everything away, she swears by Excedrin. The outcome of the event shaking recovered on an unspecified date; Joint pain and Muscle pain recovered on 19Jan2021; Blinding headache/ severe headache, Fatigue/Extreme tiredness was recovering, chills/ shivers, couldn't warm up, Neck froze completely, pulled muscles, fatigue was unknown; she can't move her head up and down normal/ couldn't move her head, Pain in her neck, Muscles were so sore, Weakness was not recovered.
77 2021-03-01 numbness and pain in extremities, tingling Back pain, bilateral lower extremity neuropathy, paresthesias, lower extremity weakness, urinary ret... Read more
Back pain, bilateral lower extremity neuropathy, paresthesias, lower extremity weakness, urinary retention, orthostatic hypotension
77 2021-03-02 weakness Shortly after vaccination, upper legs felt weak and head felt as if she was "floating" similar to b... Read more
Shortly after vaccination, upper legs felt weak and head felt as if she was "floating" similar to being put under anesthesia. Day 2 developed Redness and rash on chest and lower back. Day 3 developed a large cold sore on lower lip. Day 4 - 4 more cold sores on upper and lower lips. Day 5-6 fatigue. She was observed for an hour, offered water and juice following the vaccine and was released home.
77 2021-03-02 burning sensation Pain; Burning sensation; Hives; Injection site soreness; This is a spontaneous report from a contact... Read more
Pain; Burning sensation; Hives; Injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el1284 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 14:50 at a single dose for COVID-19 immunization. Medical history included lymphoma from May2020, had chemotherapy for lymphoma from Jun2020 to 08Oct2020, shingles, knee replacement from 2008 and allergic to penicillin. The patient's concomitant medications were not reported. Patient stated she thinks she was having side effects from the Pfizer COVID-19 vaccine she got 19Jan2021, tomorrow 02Feb2020 was two weeks from when she got it. Patient didn't have any side effects to start with, just soreness to the injection site on Jan2021. She says last Wednesday, 27Jan2021, she noticed she had hives, not a rash, on her chest on the left side that are kind of on her breast, the top of her breast, which now spread under her arm up to her shoulder area and back. There was pain along with it, a burning sensation starting last night on 31Jan2021 in the inside area. Since she got her injection on her left side, she doesn't know if this could be a reaction to the injection or not. She had shingles several years ago, this was acting like that, and it looked like one of the side effects listed is lymphadenopathy, which she looked up information about that, but she doesn't know what it was, she doesn't know what else to blame it on. Patient hasn't seen her doctor yet for hives, and has not treated the hives. She got the OK from the nurse who said she didn't see a reason for her not to get the vaccine since she was coming off chemo several months prior. Patient was considered to be in remission right now, and she has an appointment next week with her oncologist for follow up. Outcome of the events was unknown.
77 2021-03-02 hot flush, flushing Mild headache, worse than normal fatigue, stiff neck, muscle ache, hot flashes, flushed cheeks, itch... Read more
Mild headache, worse than normal fatigue, stiff neck, muscle ache, hot flashes, flushed cheeks, itching. Rash to antecubital area of right arm starting on Sunday night.
77 2021-03-02 migraine, pain in extremity DAY 1-mild headache during the day became migraine at night. Experienced chills, sweat, dizziness, f... Read more
DAY 1-mild headache during the day became migraine at night. Experienced chills, sweat, dizziness, fatigue, and sore arm (like tetanus). DAY 2-Migraine all day, chills, sweat, dizziness, fatigue, and sore arm. DAY 3- Migraine downgraded to functional migraine (I could open my eyes), sweat, dizziness, sore arm, fatigue, chills gone. DAY 4-headache, painful to move arm. DAY 5-Arm still painful to use.
77 2021-03-02 pain in extremity Got the vaccine, she went home around 3:30, and was very tired. She woke up after 6:00 PM. This mo... Read more
Got the vaccine, she went home around 3:30, and was very tired. She woke up after 6:00 PM. This morning she had swelling in her arms, real bumpy about 2 1/2" in diameter, looks like rocks, red/pink area 1 1/2". It is very painful throbbing area on her arms, getting worse. She has been taking Tylenol. She felt a little relief of the pain with the Tylenol. She rested all day yesterday. She left at 10:00 for her bridge club and that's where she noticed the reaction and has gotten home around 3:00 and not feeling well. They told her to call us as they did not have any side effects from the vaccine. She does have an appointment on 3/11/21 with her PCP.
77 2021-03-02 pain in extremity DEVELOPED APPROXIMATE 3-4 INCH RED ITCHY RASH SURROUNDING INJECTION SITE 7 DAYS AFTER 1ST INJECTION... Read more
DEVELOPED APPROXIMATE 3-4 INCH RED ITCHY RASH SURROUNDING INJECTION SITE 7 DAYS AFTER 1ST INJECTION. I APPLIED MEDICATED GOLD BOND ANTI-ITCH CREAM EACH DAY AND RASH LASTED 4 DAYS. DID NOT SEEK MEDICAL ATTENTION. RECEIVED 2ND VACCINE INJECTION 2/27/2021 WITH SORE ARM THE 2D DAY THAT QUIT THE NEXT DAY. SO FAR NO OTHER REACTIONS.
77 2021-03-02 pain in extremity Vaccinated with Pfizer COVID vaccine on 1/21/21 and 2/12/21. Unknown facility, lot number Hospital ... Read more
Vaccinated with Pfizer COVID vaccine on 1/21/21 and 2/12/21. Unknown facility, lot number Hospital course 2/24 ? 2/26/21 2/24 Chief complaint: Chest Pain. Per EMS - CP and SOB started 1220. Mid CP radiating to left arm. semi-relief with nitro x 2. Reports N. Denies V and no other symptoms. Hx cardiac stents, MI. HPI: Patient is a 77-year-old female who presents to the ER for evaluation of chest pain. Patient states that her chest pain started this afternoon around 1230 when she was cooking lunch. She says it lasted for about 10 minutes and was a intense substernal chest pressure sensation with radiation down her left arm. She had associated shortness of breath and diaphoresis and also endorsed nausea without vomiting. Patient also states she is had some occasional dizziness which she described as a room spinning sensation is made worse when she is in positions and standing or moves her head. She has a history of 2 heart attacks and 2 stents placed which were done. She has no local cardiology follow-up and she lives at an apartment and follows with pace. EMS gave her 4 aspirin prior to arrival she takes no blood thinners but she does take Plavix. Patient has a history of COPD and also endorses some wheezing, she says they took her nebulizer away from her for fear of spreading coronavirus and she is oxygen dependent at nighttime. COVID positive 2/24/21 (this assay amplifies and detects The target rna using real-time pcr. Testing performed on cepheid genexpert) Patient states she tested negative for COVID 19 last week at her PCP and got her 2nd COVID 19 vaccine on 2/11/2021. She reports having dinner with a friend 3 weeks ago who just passed away from COVID 19. EKG shows normal sinus rhythm with incomplete right bundle branch block and no obvious ST segment elevations or acute ischemic intervals Troponin negative Patient admitted to the COVID unit. Home (baseline) O2 requirement 2.5L at night 2/25: 3L O2 nasal cannula continuously, reduced to 2L within 12 hours No fever COPD with acute exacerbation: Diffusely wheezing bilaterally and in tripod position on exam. Start IV Solu-Medrol COVID-19 viral infection: Start IV Remdesivir as she is now requiring supplemental oxygen. IV steroids as above. Chest pain, history of CAD with previous stenting --Denies any chest pain on exam. EKG negative for ischemic changes. Troponin negative x1. Continue to trend troponin x2 more occurrences. --Continue Aspirin, Plavix, statin, Imdur. Anxiety disorder: Continue Prozac. Add Xanax 0.25 mg 3 times daily as needed. 2/26: medically ready for discharge to SNF COVID unit. Augmentin 875/125 x 7 days dexamethasone 6mg daily x 8 days
77 2021-03-02 pain in extremity Two hours after injection severe pain in my right knee began and continues moderately today 3/3/202... Read more
Two hours after injection severe pain in my right knee began and continues moderately today 3/3/2021. (injection given at 1452) The doctor suggested heat/cold, anti-inflammatory, brace and finally an x-ray which indicated nothing. Four days after the second injection I've experienced mild pain in my opposite thigh and fatigue. The second injection was given in the opposite arm (left). While chatting with others in recovery after second injection about knee pain, another woman said she was experiencing the same and thought it was her arthritis but it felt different.
77 2021-03-02 speech disorder walks with a cane; she has shrunk; tiredness/ extremely tired; vomited twice; lightheadedness/ Very ... Read more
walks with a cane; she has shrunk; tiredness/ extremely tired; vomited twice; lightheadedness/ Very lightheaded; sore throat/ throat is sore; loss of taste/ She has no taste; swollen and puffy mouth/ mouth swollen/puffy; experiencing dry mouth to the point that she cannot talk/ Dry mouth; can hardly talk; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), on the left arm, intramuscularly, on 23Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history included mild case of asthma from an unknown date. There were no concomitant medications. No prior vaccinations within 4 weeks. The patient reported that she received her first vaccine a week ago this past Saturday. She didn't feel anything different until 2 days later on 25Jan2021. She became extremely tired and vomited twice, became very lightheaded, has no taste, throat is sore, mouth seems like it is swelling when she wakes up in the morning, her mouth is puffy. Her mouth is getting so dry she can hardly talk. On a unspecified date, the patient reported that she walks with a cane in her own house, she normally doesn't. But since she has had the shot, she has had to use the cane in her own house, she has shrunk. The reporter did not require a visit to a physician's office or emergency room. She mentions she is scheduled for her second vaccine. The patient was vaccinated on an active aging building. The outcome of the events extremely tired and vomited was recovered, for the events very lightheaded, throat is sore, mouth seems like it is swelling/mouth is puffy, mouth is getting so dry she can hardly talk was not recovered, while for the events has no taste, walks with a cane, and has shrunk was unknown.
77 2021-03-03 migraine they gave her some IV because she was dehydrated; high blood pressure; felt like she was getting a m... Read more
they gave her some IV because she was dehydrated; high blood pressure; felt like she was getting a migraine; she started getting dizzy; she has never had a hangover but it felt like she had a hangover; she didn't feel good; she was sick on her stomach; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. Patient received the first dose of the COVID vaccine and was experiencing high blood pressure on an unspecified date in Jan2021. Patient went to the ER and they told her something in the vaccine made it go up. Patient would like to know what in the vaccine would cause her blood pressure to go up and if any has experienced high blood pressure as a side effect of the vaccine. Patient reported that she didn't feel good, felt like she was getting a migraine and after that she started getting dizzy and she thought she was going to help herself and lay down on the bed for about 45 minutes and then she got up after that and walked around on Jan2021. She felt like, she has never had a hangover but it felt like she had a hangover, that was what it felt like, and she thought she hopes that doesn't last and she got up Wednesday morning (Jan2021) and went to her podiatrist appointment. She didn't feel good but she was okay so she went to the podiatrist and then later she was fixing supper and she had some grease in a pan that she fried something in and she thought she wanted to get some water in it so she went to go with the pan and she got to the door and took 3 steps back and she thought good Lord, there is something is wrong here. She did empty the water and the grease and she thought well it is going to have to stay there, it was right at the back door so anyway. Her son came home from work and she got him get the blood pressure cuff and take her pressure and it was 158/98 and she thought, this was not good. She said she will just go lay down for a while and she went on to bed. The patient was taken into the hospital via an ambulance. She sat there until about 4-5 hours and later they got to take her blood pressure and result was 189/92 on Jan2021. They gave her some IV because she was dehydrated and she got home, she lives about 30 miles form the hospital so they got home about 3 o'clock and next day she didn't feel good but she felt better. She confirmed she was not admitted to the hospital it was an ER visit and they sent her home. She felt Thursday was not a good day she came down off of what had her up. She was going to say no to the second dose because she was sick on her stomach and drunk as a dog, she was really dizzy, very dizzy and she just had to sit down quiet her self. She was supposed to have surgery but because of COVID it has been cancelled 3 times. The outcome of the events were unknown.
77 2021-03-04 weakness Patient presented to ED with chief complaint of sudden onset dizziness, epigastric pain and generali... Read more
Patient presented to ED with chief complaint of sudden onset dizziness, epigastric pain and generalized weakness, symptoms happened the day before yesterday, resolved, she noticed when she is trying to do any activities she gets heart fluttering. Epigastric pain noted in ED. Troponin Elevated, heparin IV started for possible NSTEMI. Patient is currently admitted.
77 2021-03-04 slurring, tingling Patient states she reacted immediately after receiving the vaccine. States that she felt dizzy & lig... Read more
Patient states she reacted immediately after receiving the vaccine. States that she felt dizzy & light headed, her BP went up to 163/90 and she had tingling in her feet "as if I were wearing tight compression socks". Medical record indicates that she called 911 the day after her vaccine & reported dizziness & slurred speech. She was told to go to the ER, but did not go. She reported to her PCP's office that she had arm itching, she was anxious & fatigued as well. She also reported that she "felt funny in the back of her throat" & seemed to be coughing more. Headache also reported.
77 2021-03-04 involuntary muscle movements, muscle twitching It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; It... Read more
It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; Felt like I was going to pass out; Felt unwell; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration (at the age of 77-years-old) on 15Feb2021 at a single dose for COVID-19 immunization. Medical history included Diabetes, asthma, High blood pressure, fibromyalgia, cane user, Neuropathy. Concomitant medication included pregabalin (LYRICA) and unspecified medications ("No, I am not because it's a very long list and I don't feel good, I am jerking and I just don't feel like doing that I am sorry."). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Patient stated, "My experience with the COVID-19, I had the injection on 15Feb, the second one and I went back and sat in my chair and I was okay. And then I got up to leave and I felt like I was going to pass out (15Feb2021). So, I sat down in the chair, my husband asked for the nurse and she came and she thought it was my diabetes which I also sort of felt that, but anyway I came home and I felt unwell (15Feb2021), that afternoon and then the next day, I would feel like that and then the next day I had improved but I started with this jerking and that has been going now since then but today it's more like (incomplete sentence). At first, it was like small and now they are getting big like a jerk. I called my family doctor yesterday and I talked with the nurse and she told me that I needed to be checked within 4 hours. So, I went to one of the in and out you know places, emergency places that you can go to and she took a lot of blood, and ones that came back were okay but the other results, she is not going to get until tomorrow, I have to go back. But have you have anybody else that has had this experience?" The date when adverse event started was reported as "Started out, it was like a little twitch on Wednesday night that would have been from Monday to Wednesday and then today it's just like a jerk, it's big. My whole body is just jerking. I did not feel well the afternoon I had it. But the next day, I thought I was better and that is when the twitch started." The patient was experiencing event worse than ever. It's like a bigger jerk now. No treatment was received for the events. Lab test: "They took 5 vials of blood yesterday when I went to that doctor, and I heard for some of it, but for the rest, I will have the results tomorrow and I just had my blood drawn on Thursday from my kidney doctor. So, I have blood drawn all the time." The outcome of the event "felt like I was going to pass out" and felt unwell was recovering, and "it was like a little twitch and then today it's like a jerk, it's big/whole body is just jerking" was not recovered.
77 2021-03-04 feeling cold fever with strong chilling, body aches, head ache, slight sore throat
77 2021-03-04 pain in extremity tiny sore in her arm; This is a spontaneous report from a contactable consumer (patient). A 77-year... Read more
tiny sore in her arm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN5318, expiry date unknown), via an unspecified route of administration on 23Jan2021 at 16:00 at a single dose on the left arm for COVID-19 immunization. Medical history included back surgery on an unknow date and back pain from an unknown date. Concomitant medication included paracetamol (TYLENOL) for back pain from back surgery. The patient reported that her doctor prescribed Tylenol to ease the back pain after a back surgery that she had before. She is prescribed to take the Tylenol 4 times a day at 6 hour intervals. She stated that she read something about after taking the COVID vaccine to not take Tylenol. At the time of the report she is feeling good with no side effects but based on the report she read that after, she is not supposed to take anything, she wanted to ask will it affect the effectivity as she read in a literature that Tylenol will decrease the efficacy of the COVID vaccine. She was wondering if it is ok for her to continue to take Tylenol. The patient also reported that she only had a tiny sore in her arm on an unspecified date in 2021. She was scheduled for the second dose on 13Feb2021. The outcome of the event was unknown. The events were reported as non-serious.
77 2021-03-06 pain in extremity Sore arm, headache, fatigue, fever (100.7 deg F), took Tylenol
77 2021-03-06 unresponsive to stimuli, seizure Started having flu symptoms 3 hours after shot. By following morning had a temp of 105 and was not ... Read more
Started having flu symptoms 3 hours after shot. By following morning had a temp of 105 and was not responsive. Rushed to Hospital by ambulance. Not responsive for 2 days. In hospital for 4 days. Hospital concluded she had a temp induced seizure. Worst response they had seen. Still rests and sleeps more than normal.
77 2021-03-07 pain in extremity She can breathe better moving around but when she sits down, her breathing seems to be congested; No... Read more
She can breathe better moving around but when she sits down, her breathing seems to be congested; Nose started stuffing up again; Her nose just swells; congestion in her chest; her arm was sore/ Little pain in her right leg; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) solution for injection, intramuscular on right arm on 01Feb2021 at 09:10 AM at single dose for COVID-19 immunization. Medical history included breathing problems and COVID-19 on 31Oct2020 in which she waited exactly 90 days to get the vaccine. The patient had a small touch of pneumonia on her lower lobe of her right lung, she was on a lot of antibiotics and a strong herbal solution. She was on one antibiotic for 5 days and another for 7 days. She was on the herbal stuff for 7 days. She took all that stuff and was drinking lemon juice and hot water and breathing in lemon scent and Vicks Salve all in her nose. She also was prescribed an asthma pump. She had all that stuff going into her system. She also was tested, and she has H. Pylori bacteria. She explained her whole family must have that, it's hereditary. That wasn't her issue. However, all that she put in her stomach and in her system caused her to have stomach issues. She told the doctor that antibiotics made her sick. She told the person administering the vaccine that antibiotics made her sick and she was told it didn't matter and that this wouldn't interfere with the COVID-19 vaccine. Her stomach was all messed from all that stuff. The patient also has anxiety. She has never been treated with anxiety. She has had anxiety since she was a very young women and she has never been treated for it. When probed for any product information she had available for the medications that messed her stomach up and made her sick she provided the following information: The first medication she took was azithromycin (Z-PAK, lot number: KG0706, expiration date: Nov2021, NDC number: 0781-8089-26) that was dispensed in a little box. Dose was 250 mg which she took daily doses for 5 days. One of the doctors gave her a levofloxacin 50 mg for 7 days. She was given the pump, salbutamol (ALBUTEROL SULFATE HFA INHALATION AEROSOL, lot number: 102B4, expiration data: 20Jan2022) 90mcg per actuation. She explained she only took this once. She was so scared from this stuff. It squirted down her mouth. Another doctor prescribed her omeprazole 40 mg capsule every day because she told him her stomach was messed up. The patient was prescribed amoxicillin 500 mg tablet, take one tablet, by mouth three times daily for 14 days and clarithromycin 500 mg tablet, take one tablet by mouth twice daily for 14 days. The new doctor also had her taking omeprazole (the doctor wrote another prescription for this). However, this time the dose was 20 mg and she was prescribed to take that twice daily for 14 days. She didn't finish this medication. She told the doctor that antibiotics made her sick and the doctor explained because of her bacteria, she ordered the antibiotics to make her feel better. The patient told the doctor if she could live like this, let her not take these medications until she gets her stomach better and she would eat healthy food and find natural antibiotics at the health food store. She mentioned using oregano. She took that once a day. When she knew she was getting ready to take the COVID-19 vaccine, she stopped taking that 2 weeks before taking the vaccine. She stopped taking cholesterol medicine at night 2 weeks ago, it was making her sick to her stomach. She stopped her potassium medicine. She didn't want any of the medicines interfering with the vaccine. The patient also took an herbal medicine that was called a Spiritual, Mental, Emotional, Elevation Science of Eternal Life. It's a detox mixture that was very strong. She took this for 7 days. She had lost weight because she was not eating. The patient has always been a junk food eater. She quit eating junk food and that probably also had something to do with her being sick. She cooks all her food. There was no additional vaccine administered on the same date with COVID-vaccine. The patient has no prior vaccinations within 4 weeks. She has never had a flu vaccine, pneumonia vaccine or shingles vaccine. This was her very first vaccine. Concomitant medication was reported as none. The patient didn't know if it was anything serious, but she tried to read all the information that was given to her. She was looking at the information and she saw "if you have any difficulty breathing". That was the only one that she was having. She could breathe better moving around but when she sits down, her breathing seems to be congested. She was calling to see if this was anything serious and if she needed to go the emergency room. Since her breathing has been acting funny, she has been trying to keep moving around. She was cleaning her bathroom and the Bleach Cleaner and other cleaner opened her nose. She was listening to a town hall meeting and when she sat down to listen to it, her nose started stuffing up again. She has just been trying to get up and move around. Since she has been talking on the phone, her breathing was a little better. Her nose just swells. She got up and was beginning to eat breakfast when all of a sudden, the difficulty breathing started happening. It was around 8:45 am this morning (02Feb2021). It has improved, but when she would sit down, it would tighten up and she would have congestion in her chest. Since she has been moving around talking, it has gotten better. Sitting down has something to do with the difficulty breathing. She has had breathing problems before. The patient received the COVID-19 vaccine yesterday, 01Feb2021. She sat for half an hour afterwards and then came home. She then slept all night and stated her arm was sore on Feb2021, but it was feeling better. She also had a little pain in her right leg on the side she received her vaccine on Feb2021, which was currently gone. She wasn't sure if the breathing problems were from the vaccine or something else. The patient did not go to the emergency room or visited his physician in response to the events. She mentioned that if this continues, she probably will go to urgent care. The outcome of the event dyspnea at rest and respiratory tract congestion was recovering, recovered on Feb2021 for pain in extremity, and unknown for all other events.
77 2021-03-08 weakness Only a lack of energy, lethargic, about 24 hours
77 2021-03-08 feeling hot, weakness has not smell or taste a lot of the time; has not smell or taste a lot of the time; sight is not cle... Read more
has not smell or taste a lot of the time; has not smell or taste a lot of the time; sight is not clear; flipped out; her blood pressure went up while she was in the Emergency room; panicked; Lightheadedness; Weakness; felt a little tired at that time; atrial fibrillation/started racing/Heartbeats irregular; anxiety; couldn't breathe/shortness of breath/hard time breathing; it was cold outside by her nephew's graveside, but she felt she had to fan herself like she was overheated; her heart rate was flying; scared; she said it was not a migraine headache like she is used to, but more of a mild headache; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EM9801), via an unspecified route of administration on the left arm, first dose on 04Feb2021 (Administered between 9:30-10:00AM) at single dose for COVID-19 immunisation. Medical history included chronic migraines all her life. She said her migraines have let up as she has gotten older. She also had an irregular heart rate before, saying her irregular heart rate started in her adult life. She said she considered herself more of a "carrier" for an irregular heart rate because her irregular heart rate doesn't happen enough for her to think about it. She said she doesn't have an irregular heart rate now. She said her father had a pacemaker & her 2 brothers had heart problems; her oldest brother passed away from his heart problems & her other brother has blood pressure issues. Patient also had mild asthma as an adult. She said she worked at (name) in a dusty environment, and lived near a landfill, where a lot of her neighbors have gotten sick. She said she needs an inhaler for her asthma. She said when she needs the inhaler, she takes 3-4 puffs at a time. She said she doesn't use the inhaler every day and also mentioned that her grandfather had died of a bad asthma attack. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on the same date of vaccine. No prior vaccinations within 4 weeks. There were no concomitant medications. On 13Feb2021, the patient experienced an atrial fibrillation in which she started racing and couldn't breathe. She mentioned that she recently attended a funeral but attributed the symptoms as side effects of the vaccine. She was taken to the Emergency room where she was given cortisone and resolved her symptoms. Patient also further reported she had side effects with the Pfizer COVID-19 Vaccine. She clarified she had her first COVID-19 Vaccine dose on 04Feb2021. She said her side effects happened less than 14 days after getting the COVID-19 Vaccine. Patient thought her side effects from the COVID-19 Vaccine may have been anxiety within. She said her nephew had died of COVID-19, and when she was at his funeral at the graveside, she flipped out while she was at her nephew's funeral, she was not doing good. She said she has a history of chronic migraines, and mild asthma. She said she had to lean against a gravestone because she couldn't breath. She said it was cold outside by her nephew's graveside, but she felt she had to fan herself like she was overheated. She said her heart rate was flying, and she had an irregular heart beat. She said she left her nephew's graveside and went to an urgent care. She said the doctor at the urgent care had done an EKG result abnormal, and told her she needed to go to the Emergency Room right away. She said the doctor had called the paramedics to transport her from the urgent care to the Emergency Room at (Institute name). She said she did not have any pain, but had a hard time breathing. She said she may have been scared because her grandfather had died of a bad asthma attack. She said she has chronic migraines, but what she had at the time was a mild headache, and not a migraine. She said she has not smell or taste a lot of the time. She clarified she has had no smell or taste for a while, saying she would not be able to tell if she got the COVID-19 Virus because of her loss of taste and smell. She said she was tested the Friday before her nephew's funeral and was negative for the COVID-19 Virus. She said she has had a total of four COVID-19 Virus tests before, and all her COVID-19 Virus tests have been negative. She clarified she did not have a COVID-19 Virus test while she was at the ER on Saturday, 13Feb2021. With her nephew's death, getting her COVID-19 Vaccine had left her mind. She said it didn't dawn on her until she settled down, and she thought her high heart rate and irregular heart beat were side effects of the COVID-19 Vaccine. She said she read the paperwork that was given to her at the time she got the COVID-19 Vaccine. She said the side effects listed for the COVID-19 Vaccine is what she had, a very fast heart beat, and it was very hard for her to breath. She said the Emergency Room doctor didn't think to ask her about the COVID-19 Vaccine. She said she panicked when she got to the hospital. She said she didn't even know that someone had drew blood from her. She said someone put a label on her, and told her the label was to show blood was drawn from her. She said when she looked down at the label, she saw an IV access was put in her arm. Additional treatment reported when she was in the Emergency Room, she was given an injection (clarified as IVPB on 13Feb2021) of Diltiazem 120mg at 12:13:50 PM, she said she was given another Diltiazem 5mg injection at the same time. She clarified she was diagnosed in the Emergency Room with Atrial Fibrillation. Patient stated that her blood pressure went up while she was in the Emergency room. She said she was kept in the Emergency Room so she could be monitored up until that evening. She said after the Diltiazem injections were given, her heart rate went down. She said the Emergency Room doctor gave her a prescription for Diltiazem 120mg white capsules, and told her to take the Diltiazem 120mg every day. She said the emergency room doctor told her she could go home, and that she needed to follow-up with her regular doctor. Reported she no longer has the shortness of breath, lightheadedness, or weakness. She said had felt a little tired at that time, as well. Patient also reported that on 22Feb2021 was her first day outside of her house since last Sunday (14Feb2021) and reported she has a slight headache, and her sight is not clear. She said she now feels she has "name" back, clarifying she has recovered completely. She has a follow up with her doctor on 24Feb2021. She is scheduled to take her 2nd dose on 04Mar2021 and is asking if she should take anything before the shot. Vaccination Facility Type was a pharmacy/drug store. Vaccine was not administered at Facility. The outcome of the events was recovered on an unspecified date.
77 2021-03-08 pain in extremity Pain in left arm; slight fever; lots of chills for 1 1/2 days; fatigue; generally feeling lousy
77 2021-03-08 seizure like phenomena Beginning 2-4(injection date) dull headache on top of head 2-6 vertigo began(room spinning), followe... Read more
Beginning 2-4(injection date) dull headache on top of head 2-6 vertigo began(room spinning), followed by sinking feeling in head, followed by spasms in center of head felt like seizures. 2-19 hospitalized for CT Scan of Head 2-23 EEG in Doctor Office
77 2021-03-09 pain in extremity little tight around my neck and throat, like a tightness; Tightening in my neck and around my mouth ... Read more
little tight around my neck and throat, like a tightness; Tightening in my neck and around my mouth area; As soon as I got the shot I felt a little strange; My arms hurting a little; I did not eat anything; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via an unspecified route of administration on 25Jan2021 (at the age of 77-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing low thyroid and mostly it's food allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) 125 ug, daily for low thyroid. The consumer stated, I took the vaccine on Monday (25Jan2021), three days ago and as soon as I got the shot I felt a little strange and I came prepared because I do have some reactions sometimes. Mostly it's food allergies but I guess was being prepared, so I took Benadryl with me and I took it out of the packet. When probed for the treatment, consumer stated, "I just took Benadryl as soon as I got the shot I felt a little strange and I was prepared and I took my Benadryl with me and we stayed there I guess about 45 minutes until I felt better it would have been 12:15 and I was fine." The consumer stated, "I have been trying for two days, that was in my arms hurting a little on an unspecified date in Jan2021 and then today (28Jan2021) around noon I was feeling a reaction again. I had the tightening in my neck and around my mouth area that's where I usually get the reactions from, but for two days I have been fine and I did not eat anything on an unspecified date in Jan2021 out of the way to give me a reaction to it. Now I took 2 Benadryl and it subsided but it's still tight around my neck and a little tight around my neck and throat, like a tightness. What am I supposed to do? After I took this shot on Monday today is Thursday and I am having the same reactions that I had when I took (incomplete sentence) (pending clarification). The outcome of the events as soon as I got the shot I felt a little strange was recovered on 25Jan2021, little tight around my neck and throat, like a tightness and tightening in my neck and around my mouth area was not recovered and other events was unknown.
77 2021-03-10 weakness, pain in extremity Exactly 12 hours after second dose : Severe chills ,headache ,fever ,stabbing pains in both legs Sh... Read more
Exactly 12 hours after second dose : Severe chills ,headache ,fever ,stabbing pains in both legs Shortness of breath Chills lasting 6hours Fever 12 hours Fatigue 2 days Weakness on going.
77 2021-03-11 pain in extremity Constant pain in right leg when walking. Soreness on tongue and throat.
77 2021-03-11 seizure A few weeks after receiving the vaccination she felt confused, was going to drive. Ended up having a... Read more
A few weeks after receiving the vaccination she felt confused, was going to drive. Ended up having a seizure she said and was taken to Hospital and then to another Hospital. Stated was there for 3 days.
77 2021-03-12 weakness Was monitored for 30 mins and felt lightheaded and weak at the exit table. I was put in wheelchair, ... Read more
Was monitored for 30 mins and felt lightheaded and weak at the exit table. I was put in wheelchair, moved to a cot, and Paramedics were called. I was weak, couldn't stand without help and I felt drugged. I was taken to ER for monitoring and testing for reasons why this occurred. Continued to feel passed out for 2 hours. Tests for heart attack, diabetes and anemia were negative Diagnoses was Vasovagal attack - sent home after 8 hours monitoring
77 2021-03-12 pain in extremity March 3, 2021-Sore injection site of right arm March 4th- Injection site slightly sore March 5th -so... Read more
March 3, 2021-Sore injection site of right arm March 4th- Injection site slightly sore March 5th -sore left calf March 6th- Sore left calf a little more so March 7th- Outside left calf hot to touch & back of calf red and sore. March 8th- Same as above, and I put doterra Deep Blue ointment on it, and it relieved the heat and pain Redness is gone March 9th -Left side of body joints ached. left calf aches/applied Deep blue ointment and a Pain relief ointment . Feels a lot better March 10th- Redness gone, but still feels sore March 11th- Left leg Calf feels a lot better, I put on the ointment again. Deep Blue, and Frank Woods Pain Relief ointment. March 12- Left calf a little sore. No heat . Now my left eye has a light grey spot in it. I can see around it. March 13-Eye's don't feel right. I still have the light gray floater in the left eye.
77 2021-03-14 weakness weak feeling; heartbeat climb up and up; unnerving; This is a spontaneous report from a contactable ... Read more
weak feeling; heartbeat climb up and up; unnerving; This is a spontaneous report from a contactable consumer (patient). This 77-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318; expiration date 31May2021) via an unspecified route of administration on 05Feb2021 at 11:30 (at the age of 77-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included losartan, escitalopram, and atorvastatin from unknown dates for unspecified indications. The patient received dose 1 of BNT162B2 (lot number EL1284; left arm) on 15Jan2021 at 11:00. The patient previously received codeine on an unknown date for an unknown indication and experienced allergy. On 06Feb2021 at 13:00 the patient experienced a weak feeling and heartbeat climb up. The patient had a weak feeling, had to sit down and took her pulse with oximeter and her Apple watch. She watched her heartbeat climb up and up. She tried yoga breathing but could not slow it down. She was not sure how long this went on because it was very unnerving, but it reached as high as 105 before it started to go down. The beats went up, then down, finally started to keep going down. Once more there was a wave of the weakness through her before she stayed in the 73+ range. The patient was usually in the 60's. Since then the patient's heartbeats have been what is usual for her. During the episode the patient's husband found "rapid heartbeat" on the paper they received. The patient was concerned this happened a day after the vaccine, not within an hour. The events were reported as non-serious. The patient was not hospitalized and did not receive any treatment for the events. The outcomes of weak feeling and rapid heartbeat were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
77 2021-03-14 night sweats Week 1 flu symptoms chills, fever ,fatigue, headache Week 2 chills, fever, fatigue Week 3 intermitt... Read more
Week 1 flu symptoms chills, fever ,fatigue, headache Week 2 chills, fever, fatigue Week 3 intermittent chills, fever, fatigue, night sweats week 3 continuing, some days no issue, next day all symptions
77 2021-03-14 sciatica On the day after I had pain in my left side. On the following day, I went to the ER with severe scia... Read more
On the day after I had pain in my left side. On the following day, I went to the ER with severe sciatic. This recurred and on Feb. 24 I was admitted to the hospital with severe inflammation in my spine.
77 2021-03-14 speech disorder, seizure Seizure; Could not move nor speak; Could not move nor speak; Chills; This is a spontaneous report fr... Read more
Seizure; Could not move nor speak; Could not move nor speak; Chills; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 24Feb2021 at 10:00, at single dose, for COVID-19 immunisation. Medical history included mitral valve prolapse and ongoing food allergy (to cantaloupe). Patient did not have COVID-19 prior to vaccination. Concomitant medications included vitamin b complex (B COMPLEX) and calcium carbonate, colecalciferol (CALCIUM + D3). Patient did not receive other vaccine in four weeks. The patient experienced seizure (medically significant) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, could not move nor speak (non-serious) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, could not move nor speak (non-serious) on 27Feb2021 at 02:00 AM with outcome of recovered in 2021, chills (non-serious) on 27Feb2021 with outcome of recovered in 2021. No therapeutic measures were administered as a result of the events. Clinical course: the patient reported that she had been having chills for several hours. During the night while sleeping, she believe she had a seizure. She was awakened with her body quivering from head to toe. She had no pain. She was aware of what was happening. She could not move nor speak. The event did not last very long and, when the quivering ceased, she no longer had chills. Patient did not test for COVID-19 post vaccination. The information on the lot/batch number has been requested.
77 2021-03-15 weakness severe redness in upper arm, throbbing in wrist traveling upward to upper arm. Loss of strength/gri... Read more
severe redness in upper arm, throbbing in wrist traveling upward to upper arm. Loss of strength/grip in arm/hand.
77 2021-03-15 weakness Lymph gland under left arm size of golf ball, smaller glands swollen underarm, (soft), neck swollen... Read more
Lymph gland under left arm size of golf ball, smaller glands swollen underarm, (soft), neck swollen, left foot swollen, weakness, small blood clot in myopic of middle finger, small modules in upper thigh, sore on lower lip right side
77 2021-03-15 burning sensation Painful, burning nodules on legs
77 2021-03-15 muscle spasms 3/11/2021 Patient presented with severe upper back muscle spasms and shortness of breath for the las... Read more
3/11/2021 Patient presented with severe upper back muscle spasms and shortness of breath for the last 2 days. Diagnosed with pneumonia and hypoxia, confirmed by imaging. Covid test negative on admission.
77 2021-03-16 weakness Weakness, fiver. 98.3 Usually runs 97.3
77 2021-03-16 feeling cold Right Arm and Shoulder Stiffened up while lap swimming at 07:00 am. Felt cold and felt pressure in m... Read more
Right Arm and Shoulder Stiffened up while lap swimming at 07:00 am. Felt cold and felt pressure in my head. Came home and covered up as chills started. After 12 hours the fever gradually subsided as did the pain in my neck and shoulder. Was left with headache that remained overnight but the pressure was not like the day before. Saturday I was just tired, I think from the fever, but by the evening I was back to normal.
77 2021-03-17 cold sweat One week post vaccine, caller's mother started to feel "phlegm-y", coughing up clear phlegm. The ne... Read more
One week post vaccine, caller's mother started to feel "phlegm-y", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14.
77 2021-03-17 discomfort, muscle spasms Chills; aches and pains; chest spasms; a fever a little shy of 101; hard to breathe; feel ill; activ... Read more
Chills; aches and pains; chest spasms; a fever a little shy of 101; hard to breathe; feel ill; activated all that discomfort; she thought she was having a heart attack; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 20Jan2021 12:30 at single dose in right arm to prevent covid. Vaccination Facility Type was Health department. Medical history included rotator cuff challenge. There were no concomitant medications. No other vaccine was administered on the same date. There were no prior vaccinations within 4 weeks and no adverse events were following prior vaccinations. Patient was calling about Pfizer Covid vaccine. She had the first shot on 20Jan2021. She did not have a reaction. She went to go get her monthly massage on Saturday (23Jan2021). On Sunday morning (24Jan2021) she started to feel ill and she had to go the hospital. She confirmed she was not admitted to the hospital. She had chills, aches and pains, it felt like an elephant was on her chest, she had chest spasms, a fever a little shy of 101. She went to hospital and the doctor there told her she had covid since she had all the symptoms. She confirmed she did not have covid and had a negative covid test. She had chest x-ray and an EKG since she thought she was having a heart attack. Reported her massage was primarily on her left shoulder, it was a deep massage on that area since she had a rotator cuff challenge, massage was focused on that shoulder. She was thinking that the vaccine activated all that discomfort since she felt it from the left part of shoulder, went down to her chest like a v, and back up to her right shoulder. Every time she took a breath she had a chest spasm and it was hard to breathe. The events required a visit to emergency room. For treatment, they gave her medication to take called robaxin, it was an anti-spasm, and 800mg of ibuprofen. She took robaxin Sunday night, Monday, and she took one on Tuesday since she was feeling better. She was sensitive to medication. She felt dizzy and nausea from Robaxin. The patient had recovered from the events completely by Wednesday on 27Jan2021. She had a reminder to return for the second dose on 10Feb2021. She was asking if she should get the second dose. Information about Batch/Lot number has been requested.
77 2021-03-17 feeling hot, flushing flushes - feeling hot on her chest as per patient; BP=180/104; HR=66, O2=96RA; lungs-clear. Hx... Read more
flushes - feeling hot on her chest as per patient; BP=180/104; HR=66, O2=96RA; lungs-clear. Hx-HTZ, increased cholesterol, hypothyroid.
77 2021-03-18 feeling hot, weakness Within 5 minutes I became very light headed and weak. Also very hot and shaky. They had to put me i... Read more
Within 5 minutes I became very light headed and weak. Also very hot and shaky. They had to put me into another room that was much cooler and put me into a recliner with feet up, ice behind my neck and on my forehead. I was pushing water so it was not dehydration, and I had eaten my normal healty breakfast also so not low blood sugar. This was my second shot and I had the same reaction with the first shot. It took about an hour before I could stand and walk again, but was still a bit shaky and faintly light headed for about another hour.
77 2021-03-19 numbness Patient experienced high blood pressure, paleness, numbness and unawareness
77 2021-03-20 difficulty speaking, tremor Developed petechial rash within few days of receiving 2nd dose on bilateral lower legs. Also had com... Read more
Developed petechial rash within few days of receiving 2nd dose on bilateral lower legs. Also had complaints of tremor, weak voice and cough with deep inspiration. Appeared to be developing cellulitis to bilateral lower extremities- treated with oral antibiotic. Oxygen level was good in office, advised to monitor for worsening.
77 2021-03-21 weakness Fever, body aches, and weakness requiring IV fluids in the ER
77 2021-03-21 weakness "Pt presented to Clinic for her vaccine. Post vaccine, pt was feeling faint/weak and was pale. Pt st... Read more
"Pt presented to Clinic for her vaccine. Post vaccine, pt was feeling faint/weak and was pale. Pt sts feeling short of breath prior to arrival. Pt has hx of lung cancer. Pt was drained last at home on 3/14 per pt husband. EMS performed 12 lead and checked vitals. Pt color improved upon lying on stretcher for a few minutes. Pt's pulmonologist was contacted to see if they want her to go to her appointment scheduled at 1330 or to be transported to ED. Pt. was then transported via EMS to ED." Pt was inpt from 3/18/21 - 3/21/21 with diagnosis of E. Coli bacteremia, recurrent left pleural effusion with drain in place, resolved hypoxia on oxygen, follicular non Hodgkin's lymphoma, pancytopenia, poor appetite, insomnia. Patient was started on cefepime and then Rocephin per Infectious Disease team but she continued to the duration of this admission until ultimately transitioning her to oral antibiotics with Cipro twice daily to complete 7 day course from 03/19; this prescription was sent to her pharmacy upon discharge. Discharged home with hospice services (per pt /family preference) for comfort care
77 2021-03-21 slurring Slurred speech, extreme confusion and disorientation, headache, blurred vision. Symptoms of mild Dem... Read more
Slurred speech, extreme confusion and disorientation, headache, blurred vision. Symptoms of mild Demetia increased to meditate to severe dementia in a matter of hours.
77 2021-03-21 pain in extremity, muscle spasms 2/28/2021 DAY OF INJECTION #1 - HEAVY SENSATION IN UPPER LEFT ARM, LASTED LESS THAN 24 HOURS 2/18/2... Read more
2/28/2021 DAY OF INJECTION #1 - HEAVY SENSATION IN UPPER LEFT ARM, LASTED LESS THAN 24 HOURS 2/18/2021 DAY OF INJECTION #2 - MILD SORE UPPER LEFT ARM RADIATED TO LEFT SHOULDER BLADE, USED TOPICAL ARNICARE FOR THE SORENESS WHICH LASTED ABOUT 24 HOURS 3/21/2021 VERY SORE UPPER LEFT ARM, SUDDEN "CHARLIE HORSE" RADIATED FROM THE INJECTION SITE TO THE LEFT SHOULDER BLADE, LUMP/KNOT UNDER THE INJECTION SITE ABOUT THE SIZE OF A WALNUT, USED ARNICARE AND MASSAGE, NO RASH OR VISIBLE BRUISING, SORENESS LASTED SEVERAL DAYS
77 2021-03-22 tenderness Red whelp developed at injection site approximately 24 hours ago, it was approximately a quarter in ... Read more
Red whelp developed at injection site approximately 24 hours ago, it was approximately a quarter in size and has progressed to redness down the arm. site is red and tender to the touch. The patient has applied an ice pack to the area.
77 2021-03-23 difficulty speaking 10:25:10 minutes post receiving first dose of Pfizer vaccine pt reported having throat tightness and... Read more
10:25:10 minutes post receiving first dose of Pfizer vaccine pt reported having throat tightness and voice hoarseness "similar to when she has as asthma attack." HR 72, BP 180/60. Pt repeatedly apologizing stating "I'll be ok." 10:27:Ambulance service requested. 1030:Pt medicated w/ Benadryl 25 mg PO per standing order. 10:32 Ambulance arrived, report given to Paramedic. 1040: pt transferred to ambulance. 1045: Ambulance departs site.
77 2021-03-23 flushing facial flushing and redness, mild swelling. No shortness of breath or itching. Started within 1-2 ... Read more
facial flushing and redness, mild swelling. No shortness of breath or itching. Started within 1-2 minutes of receiving vaccine Treatment: Benadryl 50mg IM within 5 mins of reaction onset. Observed for 30 mins; feeling better; sent home; advised to call 911 if recurrent or new symptoms
77 2021-03-24 weakness She has constant spiking of her blood pressure (BP) and lack of sleep/She has been in and out of the... Read more
She has constant spiking of her blood pressure (BP) and lack of sleep/She has been in and out of the hospital for her high BP/admitted to Hospital with 200/103 Bl; she has constant spiking of her blood pressure (BP) and lack of sleep; Racing Pulse; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; This is a spontaneous report from a contactable consumer. A 77-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EL9262), via an unspecified route of administration in left arm on 25Jan2021 (vaccination age 77 years) at single dose for COVID-19 immunization. Medical history included: cholesterol, spinal fusion L4/5, stenosis, allergies to medications, food, or other products: kefex, Zithromax, levofloxacin, oxycontin, methylprednisolone, Lisinopril, ezetimibe, Amlodipine. She reported she has constant spiking of her blood pressure (BP) and lack of sleep for 37 days (average 1-3 hours daily), since the vaccination. She described the following: She has experienced "dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function". When she "lays down", her "heart is racing so fast and [her] BP gets so high that it won't let [her] sleep". She feels like her "body is going crazy". She "cannot get more than 2-3 hours of sleep other than 1-2 exceptions". Also, her "BP wakes her from a dead sleep". When she wakes up, she usually "takes a rice [pad] and applies hot and cold to her neck, and she sometimes takes some Tylenol". "Every time [she] wakes up, her BP [readings] are around 152/101 and 160/97. She has been in and out of the hospital for her high BP. After the hospital, she called (Number) because her BP "was off the chart". Her cardiologist ruled out heart issues. She did an "echo, a stress test and EKG". On 01Feb2021 she was admitted to hospital with 200/103 blood pressure. Ruled out cardiovascular & placed on Amlodipine. Now 37 Days later with many visits to doctors, blood pressure remains high. Cardiologist ran stress test & echo with no heart issues. Placed on many Blood Pressure Medications that also created side-affects (urination, flushing, dizziness, extreme headaches); Amlodipine 5 mg, Metoprolol 25 mg, Alprazolam 0.25 mg as needed, Propranol 20 mg. Today, picking up yet another (Hydralazine?) as last-ditch effort. BP daily spikes remain high (160/99 and 175/100). Racing Pulse & BP wakes me out of a dead sleep within 1-2 hours. So weak & constant neck pain that feels like someone is placing pressure around my neck. The blood pressure medication received are the following: Amlodipine from 1Feb2021 until 9Feb2021. She explained it work well to manage her BP but she "could not urinate and had red flashes in [her] face"; therefore, it was stopped by her cardiologist. She was off the BP medication from 9Feb2021 until 17Feb2021. Metoprolol from 18Feb2021 until 25Feb2021, but it didn't work. She explained it was stopped by her doctor because of side effects. Propranolol in combination with Alprazolam as needed for anxiety. She explained she "took 3" of the tablets for anxiety. Hydralazine 25mg which she started yesterday, after seeing her cardiologist. She explained she only got 3 hours of sleep last night. She woke up around 1:30am/2am" her heartrate was at "93" and she put heat and cold on her neck to settle the pain. She specified the headache and pain were so bad it lasted for 1.5 hours, and her BP was 150/93 at 3 am .She added she had a "red and flushed face" and therefore took a "Benadryl at 4am". She explained her BP was down to "125/78", after taking the Benadryl, but got up to "147/90" at 7 am when she attempted to call Pfizer. She explained she has "done [her] due diligence: she consulted HCP, did all the test, she attempted to go for walks and do activities she can tolerate, but her symptoms persist. She added she use to golf and cannot anymore. She explained her symptoms are persisting until this day and her body won't handle it further. She mentioned she knows she is COVID-19 free because when helping take care of her quadriplegic son in the summer, she tested negative. Outcome of events was not recovered.; Sender's Comments: Linked Report(s) : PFIZER INC-2021277006 same patient, different vaccine dose/AE.
77 2021-03-24 brain damage She had been in her usual state of health until tonight. Assisted living facility staff called. He m... Read more
She had been in her usual state of health until tonight. Assisted living facility staff called. He mentioned that the facility staff had earlier noticed that she was dragging her right foot and and has been needing more assistance with activities. The patient was walking and did not feel well. She was lowered to the ground and had a witnessed cardiac arrest. The ambulance was called and she was reportedly found to have pulseless electrical activity. She was given Epinephrine and Amiodarone with return of pulse. The patient was brought to the Emergency Room and was evaluated by ER physician. EKG showed atrial fibrillation, ventricular rate = 66, RBBB with Brugada pattern. She was emergently brought to the Cath Lab. Cardiac catheterization showed normal coronary arteries but EF 35-40%. Repeat EKG showed atrial fibrillation with rapid ventricular response = 110, RBBB. Therapeutic hypothermia was initiated. The patient was admitted to the ICU on mechanical ventilation with TV 350 RR 14 PEEP 5. She is sedated with Propofol and Fentanyl IV. She is on Levophed IV. ABG showed pH = 7.22, pCO2 = 53, pO2 = 66, O2 sat = 88%. Lactate level = 9.5. WBC 8.8, Hgb 13.4, Hct 46, Platelets 138. Na 138, K 3.2, Cl 102, bicarb 20, BUN 16, Crea 1.19, estimated GFR = 44 mL/minute. Magnesium 2.7. Glucose levels have ranged from 273-312. Pro-Calcitonin = 0.26. Albumin 3.7. SGOT 262, SGPT 294. Troponin elevated at 47. Pro-BNP = 600. Urinalysis showed large blood. Chest x-ray showed vague peripheral pneumonitis. Endotracheal tube is in place. COVID-19 test by PCR is negative (2/5/21). COURSE IN HOSPITAL The patient was admitted to the ICU and was followed by Pulmonary/Critical Care. Patient was maintained on mechanical ventilation, sedated with propofol and fentanyl IV. Vasopressors were administered (Levophed IV). She was managed with therapeutic hypothermia. She was followed by Cardiology. Foley catheter was inserted for close input/output monitoring. Neuro checks, vital signs, daily weights, pulse oximetry, cardiac telemetry and fingersticks were monitored. She was given sodium bicarbonate IV due to metabolic acidosis. She was also given insulin IV drip. Potassium chloride IV was administered due to hypokalemia. The patient was given amiodarone IV. Platelet count was noted to be low but stable. Glucose levels were within acceptable range. Metabolic acidosis resolved. Hypokalemia resolved. Hypomagnesemia resolved. There were elevated LFTs which improved. Elevated CPK also improved. She was taken off hypothermia protocol. Sedation was decreased and she was able to open her eyes with verbal stimulus but unable to follow commands. Ammonia level was normal. Neurology evaluated the patient. EEG showed left periodic epileptiform discharges consistent with severe diffuse encephalopathy. Chest x-ray revealed right upper lung and left mid lung increasing opacity for which meropenem IV was started. Levophed was discontinued. Initially she had peripheral cyanosis, but this resolved upon discontinuation of vasopressors. Brain MRI was done demonstrating diffuse bilateral small and moderate-sized ischemic foci throughout the cerebellum and cerebellar region suggestive of embolism. There also was chronic marked atrophy and moderate small-vessel gliosis. CIRCUMSTANCES SURROUNDING DEMISE Based on neurologic evaluation, her prognosis for meaningful neurologic recovery was thought to be extremely poor. The patient was evaluated and followed by Palliative Care. She does not have family members and had designated her neighbor friends as her power of attorney. They have known the patient for a ling time and they know that she does not want to live like this. A decision was therefore made for comfort care measures only. Compassionate extubation was performed on February 12, 2021. The patient passed away on February 12, 2021, at 6:39 p.m.
77 2021-03-24 pain in extremity, speech disorder severe pain emanating from injection site; traveled upward over shoulder; continued up right side of... Read more
severe pain emanating from injection site; traveled upward over shoulder; continued up right side of neck; heavy right earache; sore throat; headache forehead and across top of my head; dry heaves; feverish/chills/shivering; feverish/chills/shivering; words mixed up; Felt pain in center chest; congestion across bronchial area and developed upper respiratory congestion temporarily; congestion across bronchial area and developed upper respiratory congestion temporarily; fatigued; had severe coughing spell which included choking and further nausea; had severe coughing spell which included choking and further nausea; severe nausea; Ripple effect across bridge of nose; strong metallic odor and taste within mouth; moving from back of throat and nostrils; it is both painful and difficult to raise my right arm very high; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6060, first dose) solution for injection intramuscular in the right arm on 09Mar2021 at 16:00 (at the age of 77-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: yes. Concomitant medication included vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Mar2021 16:15, the patient had severe coughing spell which included choking and further nausea, ripple effect across bridge of nose, strong metallic odor and taste within mouth moving from back of throat and nostrils, it is both painful and difficult to raise my right arm very high. On 10Mar2021, the patient experienced dry heaves, feverish/chills/shivering, words mixed up, felt pain in center chest, congestion across bronchial area and developed upper respiratory congestion temporarily, fatigued. On 10Mar2021 03:00 the patient had severe pain emanating from injection site traveled upward over shoulder continued up right side of neck heavy right earache, sore throat, headache forehead and across top of my head. Unspecified treatment was provided for the events. The outcome of the events choking, coughing, nausea, ripple effect across bridge of nose, strong metallic odor and taste and smell, severe pain emanating from injection site upward over shoulder continued up right side of neck heavy right earache, sore throat, headache, dry heaves, feverish, chills/shivering, words mixed up, Felt pain in center chest, painful and difficult to raise my right arm very high, fatigued was not recovered. The outcome of the event congestion across bronchial area and developed upper respiratory congestion temporarily was recovering. Since the vaccination, the patient has not been tested for COVID-19.
77 2021-03-24 pain in extremity Severely sore left arm; chills, headache; fever; severe back and knee pain; fatique
77 2021-03-25 breast pain Pain in left armpit and left breast. Entire left arm swollen and reddened. Upper arm covered with bl... Read more
Pain in left armpit and left breast. Entire left arm swollen and reddened. Upper arm covered with blue tiny veins extending into left chest area.
77 2021-03-26 pain in extremity Pain in left left behind Calf also behind Thigh Swollen vein in left arm from wrist to high way up m... Read more
Pain in left left behind Calf also behind Thigh Swollen vein in left arm from wrist to high way up my arm . Some pain and lumps. Fast heart rate
77 2021-03-27 facial paralysis, bell's palsy I noticed my wife's face drooping about 9 PM Friday, 3/19/21. We went to Urgent Care on Saturday, 3... Read more
I noticed my wife's face drooping about 9 PM Friday, 3/19/21. We went to Urgent Care on Saturday, 3/20/21. The doctor there, diagnosed her with Bell's Palsy. She was put on 60 mg 1X/day of prednisone, and 1g of Valtrex, 3X/day. The diagnosis was confirmed by our family doctor, on 3/25/21. She has completed the medication and the Bell's Palsy continues.
77 2021-03-30 muscle spasms had diarrhea last night; had cramping most of the night; This is a spontaneous report from a contact... Read more
had diarrhea last night; had cramping most of the night; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiry was not reported) via an unspecified route of administration in Arm Left on 02Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Feb2021, the patient experienced diarrhea last night and cramping most of the night. Additional Context included, caller states that she got the COVID vaccination. Caller states that she did not know what she was getting until after she got the injection and this paper they gave her. Caller states that her daughter had called and said that there was clinic, and the lady from the clinic called and scheduled an appointment for the caller. Caller had no other vaccines on the same day as the COVID vaccine. The outcome of the event was unknown. Follow-up nformation on the lot/batch number has been requested.
77 2021-03-31 tremor On March 1, I developed bed-shaking chills, fever to 101 and diarrhea lasting for several hours. Re... Read more
On March 1, I developed bed-shaking chills, fever to 101 and diarrhea lasting for several hours. Resolved without treatment.
77 2021-04-01 weakness The 2-3 days after the shot my mom got a fever (over 100 degrees) and the chills which we were able ... Read more
The 2-3 days after the shot my mom got a fever (over 100 degrees) and the chills which we were able to control with Tylenol for the most part. However, over the next 4 weeks, my mom gradually lost the ability to control her bladder function, and her ability to transition between sitting, standing and lying down w/o help. She also exhibited even more difficulty with walking than she did before (shuffling). My mother experienced pain all throughout her body, and the pain became as bad as an 8-9 in a range of 1-10. She struggled to raise her arms, reach her arms out, or grasp objects. She lacked energy, she would sleep for 10 hours every night, and she had difficulty concentrating and remembering what she was reading,
77 2021-04-01 weakness weakness, diarrhea
77 2021-04-04 nerve pain Severe muscle/nerve pain in neck, back, gluts, hamstrings while in bed from 3 am to 6 am. It has oc... Read more
Severe muscle/nerve pain in neck, back, gluts, hamstrings while in bed from 3 am to 6 am. It has occured for four nights five days after the vaccine shot. Daytime okay. Taking Tylenol 625. Did not affect it. Need advice if this is a reaction or I should see a doctor.
77 2021-04-06 muscle twitching I started feeling weird in my head, terrible ringing in my ears like 10x's worse than normal, spaced... Read more
I started feeling weird in my head, terrible ringing in my ears like 10x's worse than normal, spaced out that I can hardly function, dizziness, misplacing things, disoriented, left eye twitching, vision is more blurry than normal. (patient stated she didn't know if she can live like this because it makes her want to take her life)
77 2021-04-06 nerve pain Diffuse body aches, muscle tenderness and neuropathic pain beginning 1 day following injection. No ... Read more
Diffuse body aches, muscle tenderness and neuropathic pain beginning 1 day following injection. No abnormal physical exam findings.
77 2021-04-08 pain in extremity She got the vaccine, did not have any reaction or that she was even given a vaccine. Then around 7... Read more
She got the vaccine, did not have any reaction or that she was even given a vaccine. Then around 7:00 PM her arm started to get a little sore but kept moving it and massaging it. She then could not move anything by 10:00 PM, and had gone straight to bed as she felt so bad. She was dizzy, light headed, and these symptoms continued all night and all day Thursday. She dozed to sleep off and on all day Thursday and was in so much pain, didn't have to move to have pain. She is still having some pain today, but feeling much better. She still is a little bit dizzy. Feels as if she laid down she could sleep for a long time. She has pain in her back area, her arms, her hips. She did not take anything for her reaction as was told not to take aspirin and does not use other medications. She feels exhausted and if she moves her arm too much and also her legs then they start to hurt. Getting in and out of bed is easier today, but she could not get them over the bed to get in or out on Wednesday. Her neck also hurt to turn. She had similar symptoms to when she had the COVID virus in November/December. She had been hospitalized for it twice, was informed that she had a stroke after she had passed out.
77 2021-04-08 pain in extremity headache; fever; severe back and leg pain; severe back and leg pain; fatique; Extremely sore arm; ch... Read more
headache; fever; severe back and leg pain; severe back and leg pain; fatique; Extremely sore arm; chills; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration, administered in left arm on 23Mar2021 15:15 (Lot Number: ER8730 and expiry date not reported) as single dose for covid-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included atrial fibrillation, hypersensitivity and diverticulitis (start and stop date was unknown for all). Concomitant medication(s) and patient received within 2 weeks of vaccination included: hydrochlorothiazide, losartan potassium (LOSARTAN HCT); dronedarone hydrochloride (MULTAQ); omeprazole (OMEPRAZOLE) and levocetirizine (LEVOCETIRIZINE) all taken for an unspecified indication, start and stop date were not reported. On 24Mar2021 at 01:30, the patient experienced extremely sore arm, chills, headache, fever, severe back and leg pain, fatigue. The patient did not receive any treatment for the adverse event. Outcome of the events was recovering. Additional information has been requested.
77 2021-04-09 weakness, sciatica sciatic nerve just blow up. This time it quickly turned into tremendous pain; no energy; I slept mos... Read more
sciatic nerve just blow up. This time it quickly turned into tremendous pain; no energy; I slept most of the time; tired; chills; fever; headache; flu-like ache; muscle pain; queasiness; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 19Feb2021 at 13:15 (at the age of 77-years-old) as single dose for COVID-19 immunisation. The patient took the first dose of BNT162b2 (lot number E13246) on 27Jan2021 at right arm for COVID-19 immunisation. Medical history included High blood pressure (BP) and cholesterol, all managed. The patient had also history of sciatica nerve pain in in early Jan2021, resolved with 5 days of meloxicam. Concomitant medication included atenolol, hydralazine, pravastatin and budesonide/formoterol fumarate (SYMBICORT). The patient reported that 2 hours after vaccination, at home, she felt tired, quickly turned to chills and fever. Body temperature was 99.9 F. She never run temps. This was followed by headache, flu-like ache, muscle pain, queasiness, and just terrible in general. She spoke with nurse who gave her shot to see if I should take any fever reducers. She said try to hold off, but if bad, take Tylenol or Ibuprofen. On 20Feb2021 sciatic nerve just blew up. She had an episode in early January, but Meloxicam worked in 5 days and she was fine. This time it quickly turned into tremendous pain-could not walk without help, trouble getting in or out of bed and to the bathroom. She was screaming out in pain. She started taking Tylenol and then Ibuprofen. Nothing helped. She had a few Meloxicam pills left and took one 22feb2021. Temps were rising daily (101.5) chilled, no energy. She slept most of the time straight chair. Sciatica was better, but not gone. Day 9, she walked outside, temp was normal. She was sent for flu & Covid tests (nasal swab), both negative. The outcome of events was recovering. No follow up attempts are possible. No further information is expected.
77 2021-04-09 weakness I am 77. I had the Pfizer vaccine, March 9th, with a terrible reaction starting 2 days after. I c... Read more
I am 77. I had the Pfizer vaccine, March 9th, with a terrible reaction starting 2 days after. I couldn't use my brain to think, to read with comprehension, to remember things I wanted to remember and had difficulty finding my words. This lasted for 3 days when the fog began to lift. I also had some shortness of breath(SOB) and very low energy. The CDC has said that when giving the injection it is no longer necessary to aspirate (pull back on the syringe) which I was taught to do as a young nurse to ensure that you are not giving the injection into a vein (blood would appear in the syringe.) It is supposed to be given into the muscle which has plenty of veins so if you don't aspirate, how will you know if you are injecting into a vein? A week later, I ended up going to the local hospital ER because of the SOB and had Chest xray, EKG, brain Cat Scan and blood work which were all normal. I debated about getting the second shot but decided to get it as long as the injector gave the injection as I had been taught. Fortunately she was very experienced and agreed to inject me using the pullback method after I explained what I had gone through the 1st time. So for the second shot I had the sore arm but no other reaction. I think Dr is making a mistake about the pullback decision. Do we even know what happens if the vaccine is injected into a vein? I am not certain if my first shot was injected into a vein because the injector never pulled back to check. I have not heard of anyone else with my experience.
77 2021-04-09 pain in extremity a really bad headache; a very sore arm; fever with temperatures of 100.3 to 101F; She's not feeling ... Read more
a really bad headache; a very sore arm; fever with temperatures of 100.3 to 101F; She's not feeling good at all; Feels miserable/horrible and woozy; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (Formulation: Solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included , thyroid disorder from an unknown date and unknown if ongoing Thyroid is low ,diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included metformin at 500 mg taken for diabetes mellitus, start and stop date were not reported and levothyroxine sodium (SYNTHROID) at 100 mcg taken for thyroid disorder, start and stop date were not reported. The patient previously took Historical Vaccine BNT162B2 (she got her first shot on 19Jan2021 with no side effects; Batch/lot number: EN9581; Dosage text: Once by injection in the left arm )on 19Jan2021 for Covid-19 immunisation. The patient experienced a really bad headache, a very sore arm , fever with temperatures of 100.3 to 101f, she's not feeling good at all , feels miserable/horrible and woozy on 10Feb2021. she received the 1st dose of the vaccine last 19Jan2021 and had no side effects. She received the 2nd dose yesterday and woke up in the middle of the night due to a really bad headache and a very sore arm. She woke up today and still had the symptoms along with a fever with temperatures of 100.3 to 101 F. She's not feeling good at all and is asking if these are all common side effects of the vaccine and on what she should do. The patient underwent lab tests and procedures which included body temperature: 100.3 fahrenheit on 10Feb2021 she took it again at 1:25 and it got up to 101. The action taken in response to the event for bnt162b2 was not applicable. The outcome for the events a really bad headache, fever with temperatures of 100.3 to 101F, and Feels miserable/horrible and woozy not resolved and for other events was unknown. Information on the lot/batch number has been requested.
77 2021-04-12 night sweats Extreme headache rot. Side of head, extreme back pain in left wing one , Runny nose, Chills to... Read more
Extreme headache rot. Side of head, extreme back pain in left wing one , Runny nose, Chills took Tylenol and napped for hrs for two days. 2 heavynosebleeds right nostril one wk later. 2nd shot on 2-21-2021, Hot, 4 nights of night sweats, Two more bloody noses right nostril. Tired
77 2021-04-12 tremor, unresponsive to stimuli 1325 Pt sitting in chair in OBS. Pt appeared slightly vague and hands shaking. Pt did grasp bottle... Read more
1325 Pt sitting in chair in OBS. Pt appeared slightly vague and hands shaking. Pt did grasp bottle of water when given. Pt unable to open water bottle and increase hand trembling noted. Pt began leaning forward. Pt did not respond when asked name or if she needed help opening water bottle. Pt became unresponsive and slouched forward with left UE contracted and gerbilled words unable to identify. EMS activated. Pt eased to floor without complications with EMS asst. Pt aroused after appx 10-15 sec with verbal cuing. Pt alert and oriented, unable to remember all details, diaphoretic. Pt asst to med eval room via WC. Within 2 minutes of obtaining pt demo and info, pt displayed another episode as previous: unresponsive, left UE contractured and diaphoretic. EMS assessed eyes/pupils-fixed and non-reactive. Pt arouse again with vague and confusion. Pt denies hx of SZ or TIA. No loss of bowel or bladder. Reports dizzy and confused. IV started to left posterior wrist by EMS and EKG complete-SR. TC to pt daughter information given. Pt to be transferred to medical center. Pt A&O. Pt transferred to stretcher with asst. and HOB elevated. Pt with personal belongings and reassured to return in 3 weeks for 2nd dose of vaccine.
77 2021-04-13 flushing Flushing of face and forearms, lasting a few minutes at a time. Occurring intermittently, up to 3-4 ... Read more
Flushing of face and forearms, lasting a few minutes at a time. Occurring intermittently, up to 3-4 times per day
77 2021-04-13 pain in extremity right ear and right neck pain.right foot pain and swelling.fatique. dysequilibrium. diffuse pruritis
77 2021-04-14 pain in extremity, hot flush 1/20 vaccination About 2 weeks later, I started getting up in the mornings with my hands hurting. I ... Read more
1/20 vaccination About 2 weeks later, I started getting up in the mornings with my hands hurting. I was doing water aerobics and stopped. I called the doctor and explained having pain in my hands. I have been using different ointments for the pain. *blood work scheduled with f/up with PCM 4/30 Hot flash experienced 2-3 days after vaccination.
77 2021-04-15 weakness Chills, sweats, fever for 2 days Excruciating headache for 3 days Nausea, severe for 3 days Nausea, ... Read more
Chills, sweats, fever for 2 days Excruciating headache for 3 days Nausea, severe for 3 days Nausea, moderate to light for 4 more days Weakness 5 days Dizzy, foggy condition for 5 days These symptoms were simultaneous for close to a week Not inclined to get booster in 12 months
77 2021-04-15 numbness, tingling pt stated her middle finger was tingly/numb then by time she left she said it had eased up
77 2021-04-15 seizure After vaccine it was almost a month later, the bed was shaking and she was having a seizure. I tried... Read more
After vaccine it was almost a month later, the bed was shaking and she was having a seizure. I tried to get her back on target and called the ambulance. In the ER she started having a seizure again and I called the ER doctor. He said if that's what happened earlier and said its definitely a seizure.
77 2021-04-17 cold sweat, muscle spasms she and they thought she was having a heart attack; she must have passed out because she didn't reme... Read more
she and they thought she was having a heart attack; she must have passed out because she didn't remember all the tests; she got a sharp pain underneath her left rib cage/pain was number10/still had pain off and on, periodically; broke out in sweat, real bad, number 10, she broke out in a clammy sweat; hard to breath, she got a sharp pain underneath her left rib cage; the muscle that goes around her heart, it was having like a charley horse; heart rate, She says 102, 103, it went up to 200 in the ambulance.; chest pain; Nausea; hard to breath, she got a sharp pain underneath her left rib cage; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as single dose for COVID-19 immunization. Medical history included ongoing atrial fibrillation for a about 6 years , ongoing anemic for the last 20 years, glaucoma from 1998, had both eyes operated on and in 2016 she was operated on again, cataract had this 4 years ago in she says, in 1918, 1919, she clarifies 2018, Cardiac pacemaker insertion which pacemaker that controls her heart so the pulse does not drop below 65. She says that pacemaker was implanted, she thinks, 2014 maybe, blood pressure, arthritis throughout her body and had 30 operations, body doesn't absorb what she eats, anxiety, asthma, muscle spasms; she reported she has had a lot of surgeries, both of her ankles have had triple fusions, these were in 2005, 2010, 2014, 2018, both her ankles were fused, she had 5 surgeries on her feet; she has had both of her knees replaced because of arthritis, 2012 and 2015 she believes, had numerous other surgeries and she doesn't want to go through all of them, a right shoulder reverse rotator cuff repair, she had a rotator cuff put in, she doesn't have a rotator cuff, this happened in 2019, her left shoulder, because of an automobile accident, rotator cuff was so damaged that they couldn't repair it, she has minimum use of her left arm and has had operations on her left shoulder in 2005; had a pacemaker put in about 6 years ago, the next morning they kept her overnight, they came in, they took an Xray, she had to go back 2 days later because the lead had come of the heart, they had to go back in an reattach the lead to the heart; 2 years ago her pacemaker was going all over her chest, the doctor did not believe her and it landed under her armpit, it was the size of an orange, the doctor thought it was a lump, she went to the hospital, her pacemaker started falling apart, they took it out and put a new one in, it was about 4 years ago; a lump in her breast, she has been put under 30 times, they were all necessary, nothing for glamorizing; had surgeries in her left arm and some fingers than were numb. There was no prior vaccinations within 4 weeks, no events prior vaccinations and no family history. Ongoing concomitant medication included baclofen taken for muscle spasms for about 2 years, calcium for arthritis and her bones degenerate for 30 years, ergocalciferol (CALCIFEROL VIT D) taken for gets anemic real easy for 20 years, duloxetine taken for anxiety, taking this about 3 years ago; ferrous sulfate taken for anemic real easy for about 20 years; folic acid taken to rebuild cells taking this she thinks in 2015, furosemide taken for a diuretic to get rid of fluid for 2 years, metoprolol tartrate taken for atrial fibrillation, and blood pressure, taking this since she had her pacemaker put in; montelukast for asthma for 20 years; hydrocodone bitartrate, paracetamol (NORCO) taken for arthritis for 20 years, and warfarin taken for blood thinner/thin the blood out so she doesn't get blood clots; and adults vitamins for bone supplement and metabolism for 20 years as her body doesn't absorb what she eats. She says she takes a lot of medications and when she does blood bloodwork she was low so they make her take them. The patient previously took rivaroxaban (XARELTO). On 06Feb2021, the patient experienced she thought she was having a heart attack. The patient reported that she had to call an ambulance at 11:30 at night, she thought she had a massive heart attack. She had chest pain, nausea, it was hard to breath, she got a sharp pain underneath her left rib cage. She stated that when the ambulance got here they thought she was having a heart attack, they did nitroglycerin, when they got to the house, when in the ambulance on the way to the hospital they did another pill of nitroglycerin when they got to the hospital. The pain was a number 10. She stated she broke out in sweat, once they got her all hooked up they got to the hospital 6 miles away to the hospital. She was there for 2 full days, they did Xrays, dye in her, checked her hears, and did bloodwork. When she had chest pain, she reported they gave the morphine, it lasted about 6 hours; she still had problems breathing, they took her, she must have passed out because she didn't remember all the tests, she was in and out of it, the severe pain stopped after 6 hours, still had pain off and on, periodically. When she got pain in the ambulance then the nausea went away. After the hospital nitro and another shot for the pain, the nausea stopped. After the hospital after this they gave morphine and the pain subsided a little but didn't totally go away until 6 o'clock in the evening, she still had problems breathing because every time she breathed she got pain under her left rib cage. She says the sweat was at home, real bad, number 10, she broke out in a clammy sweat, on the 6th when she was having pain. She says that after the hospital, a couple days after that, she saw her cardiologists, he told her what happened, it was related to vaccine, it was the muscle that goes around her heart, it was having like a charley horse, he says it felt like you're having a heart attack, her tests said her heart was good. She talks about her blood pressure and heart rate, and says 102, 103, it went up to 200 in the ambulance. She says they thought it was a heart attack, her blood pressure was usually low blood pressure and all the symptoms she was having was because of her muscle having a charley horse that felt like it was coming from the heart, if they had contacted him, he said she would have just needed a massive amount of anti-inflammatory and it would have stopped the pain. The events required an emergency room visit. She wanted to know if anybody else has been hospitalized for massive heart attacks and says that's what she was having. The patient had her second shot on 22Feb2021. Outcome of event nausea was recovered on an unspecified date; and outcome of the rest of events was unknown.
77 2021-04-17 pain in extremity Bleeding; Blood in her stools; Volumes of regular stool/went to the bathroom 20 times; Did not have ... Read more
Bleeding; Blood in her stools; Volumes of regular stool/went to the bathroom 20 times; Did not have blood on the toilet paper, no rectal bleeding, and had volumes of regular stool/there may be something in the vaccine that could help her Irritable Bowel Syndrome; Aching arm; This is a spontaneous report. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9267; Expiration date was not reported) on the left arm on 28Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the Health Department. Medical history included ongoing irritable bowel syndrome for over 50 years; high level of hormones; was losing hair; and had rectal bleeding from Jan2021 to an unspecified date. Concomitant medication included ongoing spironolactone from Jan2021. On 01Mar2021, the patient did not have blood on the toilet paper, no rectal bleeding, and had volumes of regular stool, and mentioned that there may be something in the vaccine that helped her irritable bowel syndrome; and had aching arm. On 02Mar2021, the patient was bleeding; had blood in her stools; and had volumes of regular stool, and went to the bathroom 20 times. The patient did not receive any treatment for the reported events. The outcome of the events was unknown. The patient had received the second dose of vaccination on 28Mar2021.
77 2021-04-18 pain in extremity Patient walked into clinic on 4/19/2021 to report adverse reaction that started on 2/27/2021. She s... Read more
Patient walked into clinic on 4/19/2021 to report adverse reaction that started on 2/27/2021. She stated that her arm had pain and was not relieved by cold compress, warm compress, and Aspercreme. Recommended that she follow-up with her primary care physician for possible injury at injection site.
77 2021-04-18 tingling, numbness Initially pt had general myalgias- now only have numbness and tingling in left hand
77 2021-04-19 brain damage, tremor, mild one side paralysis, inability to speak Pfizer COVID Vaccine EUA Patient received Pfizer vaccine 3/3/21. COVID Positive 3/20/21 3/20/21: Pa... Read more
Pfizer COVID Vaccine EUA Patient received Pfizer vaccine 3/3/21. COVID Positive 3/20/21 3/20/21: Patient is a 77-year-old female with past medical history of bilateral breast cancer (post bilateral mastectomy), CHF, CAD, CKD stage II/III, HTN, obesity, obstructive sleep apnea (not on CPAP), and spinal stenosis presenting today. Patient presented via ambulance her daughter. Patient was unable to cooperate, HPI obtained from patient's daughter. Patient's daughter stated approximately 1 week ago patient started to be "unresponsive" and was not talking/responding often. Mostly answered "yes/no" questions. She seemed the be "acting different". When asked, pt denied any pain over the last week. Her daughter denies any infectious process such as fever/chills or cough cough. Her daughter notes approximately 2 years ago patient has similar event, was seen in the ED, but nothing remarkable was found. Reviewed today, patient's daughter stated the patient had a "shaking "episode in had "on responses ". It was described as "shivering" and a blank stare during this unresponsive state. Episode lasted approximately 1 minute. The daughter denied any history of strokes or seizures. Pt usually lives with another daughter and so the daughter present was unable to verify if pt takes her prescribed medications daily. Her daughter denies knowing any Advance Directives or POA set up. Smoking, alcohol, and illicit drug use were denied. Pt was seen 9/2019 for a similar event with concern of stroke vs syncope vs TIA that resolved on its own. 3/25/21: 77-year-old F presented on admission that began approximately 6 days prior. HPI obtained from patient's daughter on admission. Patient's daughter stated approximately 1 week ago patient started to become "unresponsive" and was not talking/responding often. Mostly answered "yes/no" questions. Patient's daughter stated the patient had a period of unresponsives and was shaking her left arm on the day of admission. It was described as "shivering" and a blank stare during this unresponsive state. Left sided weakness was noted. In the ED, vitals signs significant for 88% on room air. CXR showed bilateral infiltrates in lower lobes, CT of head was unremarkable, EKG normal sinus with sinus arrhythmia, CT of chest completed due to elevated D-Dimer showed no PE but showed ground-glass airspace disease and stable 14mm nodule at lower pole of right thyroid. Pt was admitted for Acute Encephalopathy with unknown etiology. COVID testing came back positive. Patient started on Routine COVID management protocol which included IV dexamethasone, remdesivir, vitamin D, vitamin C, zinc, with daily labs (d-dimer, CPK, CRP, CMP, LDH until stable/not upward trending). Patient to continue vitamin D, vitamin C, and zinc upon discharge to rehab. Patient had MRI obtained which showed scattered foci of acute infarcts right posterior parietal lobe/multiple foci of acute microhemorrhages likely hypertensive. Neurology consulted, stated infarct could be due to COVID so continued on lovenox and stopped aspirin. Recommended to keep blood pressures 110-140/80-90. Last documented note from neurology was 03/22/2021 - contacted multiple times but unable to reach afterwards. Discharging patient on xarelto for 30 days and recommending to follow-up outpatient to transition to aspirin and plavix. With this management on board, patient's symptoms improved significantly since admission. Patient discharged in stable condition to rehab.
77 2021-04-21 tremor Was feeling nervous and shaky prior to arrival at vaccine center, not much to eat today. Received Pf... Read more
Was feeling nervous and shaky prior to arrival at vaccine center, not much to eat today. Received Pfizer vaccine #2, few minutes later, shakiness increased, with observed mild physical shaking of arms. Patient brought to Med Obs #1, Assessed by PA and MD. VS initially at 1405- BP 174/80, HR 72, R 16, O2 sat 100, CTA, RRR, no focal neuro signs, mild B arm tremor, voluntary. Pt observed x40 minutes, shakiness resolved, VS 1415 HR 72, R 16, 156/81, O2 100%, pt released to son at 1445.
77 2021-04-22 weakness chills flu like symptoms weakness sore gums sore lips with sores painful bumps at injection site
77 2021-04-23 weakness I felt very tired verbatim/ exhausted; low energy; felt lousey for about 6-8 hours; This is a sponta... Read more
I felt very tired verbatim/ exhausted; low energy; felt lousey for about 6-8 hours; This is a spontaneous report received from a contactable consumer (reporting on herself). A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Lot Number: EK9231and Expiration Date was not reported), via an unspecified route of administration in in Arm Left on 12Jan2021 12:00 as single dose for COVID-19 immunization. Medical history included, asthma, urticaria from an unknown date and unknown if ongoing , crohns disease all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 for covid-19 immunisation and experienced drug ineffective, covid-19 pneumonia, rash. The patient previously took cephalexine and experienced drug hypersensitivity. It was reported that when patient received her second injection, 2 was out of Quarantine for Covid. Also she asked her doctor If she Should even both to have this injection because apparently she had had Covid pneumonia, through by 02Jan2021. She was feeling a lot better , she was advised by her doc to go ahead & have it., which she did. No problem from Noon when she got shot to Noon Next day, but after lunch ,felt very tired, exhausted & low energy, was very wcepcited, lay on the cover, went to bed early & woke up next day feeling fine. Test: Blood test for HLA-B27 had lite @ 3x the testing Date: 15 years ago Also 25 yrs ago Result: Yes always 3x Comment: This is for Ankylosing spondylitis, Crohn's disease, Citifies, All of which she have had, the as ongoing.The outcome of the events was unknown.
77 2021-04-23 feeling hot allergic response to isopropyl alcohol in second dose of COVID vaccine; 1st dose last 22Jan2021 - 2n... Read more
allergic response to isopropyl alcohol in second dose of COVID vaccine; 1st dose last 22Jan2021 - 2nd dose was on 08Feb2021; 1st dose last 22Jan2021 - 2nd dose was on 08Feb2021; doesn't feel good; one heck of a temperature; By doing what she did, if that negated the COVID vaccine/ That's what she was afraid of; redness and swelling in her right arm; redness and swelling in her right arm; feeling hot all over the body; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 08Feb2021 at a single dose for covid-19 immunisation. The patient's medical history included weakened immune system because of the alcohol allergy (started while 19), and aches and pains. Concomitant medications were not reported. The patient received the first dose of bnt162b2 (expiry date May2021) for COVID-19 immunisation at the age of 77 years old last 22Jan2021 administered on the upper righthand arm later clarified as upper right arm; and she was still going through that systemic reaction when she had her first COVID vaccine. The patient asked on regarding how effective the vaccine was related to receiving steroid therapy. Patient was advised by doctor to go to urgent care to have a covid test to see if she and husband were exposed to covid before the vaccines kicked in. Patient stated that on an unspecified date in 2021, she still didn't feel well and was running one heck of a temperature (increased). Patient reported she had a severe allergic reaction to the vaccine. She filled out the forms. Patient felt like she should be put in the hospital. She has a horrific allergy to alcohol. Each time she receives an injection it gets worse. She knew when she received the second dose that the third ingredient was alcohol. She thought about was worse, the virus or the reaction. Within a minute of taking the vaccine she had a reaction. She reported it at the site and was watched for a half hour. Her question was "because she took prednisone immediately after getting the vaccine does that negate the shot?" She was not asked the name of the steroid that she took. She was taking prednisone 20mg, 2 tablets as soon as she gets a shot then 2 daily Monday-Friday. It was still going through her system and it was reeking havoc on her. If she goes to the hospital they will give her Benadryl and monitor her. Patient stated that on 08Feb2021, she had an allergic response to isopropyl alcohol in second dose of COVID vaccine. Patient stated that she had both COVID shots and had adverse reactions and took some medicine for the adverse reaction and now the patient was concerned it might mess with the shot, it might not work for her as it should. She knew that this was going to be a long process and she knew her allergies were rare, but they were there. She is allergic to isopropyl alcohol, even if it is in shampoos or liquid soaps, she gets reactions. She had her first COVID vaccine and she had her own hospital cleanser that she has with her at all times and she used it which was not a problem. For her second COVID vaccine, the nurse was naming the 3 ingredients that were in the COVID vaccine and asked if she was allergic to any. She said this last shot had alcohol in it, she sat with her husband next to her, and thought which was worse: getting COVID, the cases in the city are high, or having a reaction to the alcohol. She chose the latter. When it went into her arm she immediately knew she was getting a reaction. She had steroids with her just in case this happened. Each time the reaction happens, it gets worse. She said she sat for half an hour and has been on steroids until last Friday. She was supposed to be on them for days. On Friday, she was wondering if taking the steroids negated the effectiveness of the COVID vaccine and that's why she called in. She knew that this was rare and it was not something that the company going to say that the company know how to fix it. Patient worked in the health unit of a university as a hiring and firing people person. So, she was around it, but she was not a doctor or a nurse. So, she guessed the answer was no. Last week she received her second COVID vaccine. She said, she has got to get rid of 5 pounds, but it's harder to do that when you're older. She experienced the reaction from the isopropyl alcohol within her second dose of the COVID vaccine last week, 08Feb2021. She said she was still going through it and will for a while. When asked for the outcome, she said she couldn't answer that honestly. She said she didn't feel good (2021). Period. She knew that when she goes through this it takes, each time, an extra 4 to 5 days to get over it. When she got up this morning, she didn't feel good. Her husband asked if she wanted to go sailing, and she said not in 30 degree weather, but for her to say no to sailing, her husband knew she didn't feel well. She couldn't say worse, but she can say she didn't know how long it was going to be, which was scaring her. By doing what she did, if that negated the COVID vaccine, then lets go from there. That's what she was afraid of. When she tells people she is allergic to alcohol, and when it happens, they look at her like "nobody is allergic to alcohol." She is 77 and has the aches and pains of a 77 year old, which she hates. But she doesn't think there are related medical conditions to what she experienced. This (allergy to alcohol) started when she was 19 and it has gotten progressively worse. So she tries to be careful. She says this was her, not dumb, but her decision that she made and now she is concerned. She said no to any tests done. She had the immediate reaction and she knew what to do. Patient further reported that she has allergy to alcohol and had an adverse reaction after the 2nd shot due to alcohol swab and on an unspecified date in 2021, she experienced redness and swelling in her right arm and feeling hot all over the body. Patient asked if her doctor will prescribe Benadryl to manage my allergy will it affect the effectiveness of the PFIZER-BIONTECH COVID-19 VACCINE. Therapeutic measures were taken as a result of the event "allergic response to isopropyl alcohol in second dose of COVID vaccine". The patient did not recover from the event "allergic response to isopropyl alcohol in second dose of COVID vaccine". The outcome of the other events reported was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Linked Report(s) : 2021167304 PFIZER INC
77 2021-04-23 night sweats, weakness bone very painful for 24 hours; Extreme fatigue; weakness; muscle and bone very painful for 24 hours... Read more
bone very painful for 24 hours; Extreme fatigue; weakness; muscle and bone very painful for 24 hours; swelling at the entry of the injection; knot at the entry of the injection; just feeling unwell; Night sweats; lethargic; This is a spontaneous report from a contactable consumer(patient). A 77-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9246), via an unspecified route of administration, administered in left arm on 02Feb2021 23:15 as SINGLE DOSE for covid-19 immunization. The patient's medical history included knee replacement, 3 times pneumonia, surgery for mitral valve repair ablation and atrial fibrillation, all from an unknown date and unknown if ongoing. On 25Jan2021 at 2:00 pm patient received first dose of Bnt162b2 (Lot no: EL3249) in left arm. On 11Feb2021 10:30 pm patient experienced bone very painful for 24 hours, extreme fatigue, weakness, muscle and bone very painful for 24 hours, swelling, knot at the entry of the injection, just feeling unwell, night sweats and lethargic. Outcome of the events was not recovered.
77 2021-04-24 weakness Headache; Tiredness; Difficulty breathing; Dizziness; Weakness; Nauseated; blood pressure was up; Te... Read more
Headache; Tiredness; Difficulty breathing; Dizziness; Weakness; Nauseated; blood pressure was up; Teeth chattering/chills; couldn't hardly stand up; This is a spontaneous report from a contactable consumer (patient reported herself). A 77-year-old female patient received first dose of BNT162B2 (COVID shot, Solution for injection, NDC number: Unknown) via an unspecified route of administration to her right arm on 24Feb2021 3 PM (Batch number: EN6201) as single dose for Covid-19 immunization. Vaccination Facility Type: Hospital. The patient's medical history included bladder issue (she had just been to see her doctor for bladder issues, this was prior to taking the COVID shot). Concomitant medications was reported as none. On 24Feb2021, the patient experienced blood pressure was up, teeth chattering and could not hardly stand up. On 24Feb2021 3 PM, she experienced nauseated. On 25Feb2021, she experienced headache, chills, tiredness, difficulty breathing, dizziness and weakness. Caller, reporting on the COVID shot, said that she had a reaction and had to go to the hospital. She was calling to report. It was explained that she was sick all over which she clarified as being nauseated. At first she said it started an hour to hour and a half after the shot but then clarified she got the shot at 3 PM and the event started that night. The caller was treated and released. She went to the hospital about 6 PM and was sent her home about 9 PM. She was given a steroid shot, Benadryl, her teeth were chattering and was given a pill for that. It was noted while at the hospital she could not hardly stand up. Also, her blood pressure was up and they had to get that down before she left; she was given a pill to get that down. Her blood pressure was 225 but she did not know the bottom number. She was taking the medication given and taking it easy. She was having headache, chills, tiredness, difficulty breathing, dizziness, and weakness. This all started today. The nausea was ongoing from yesterday. The caller explained that she did not think that she should take the second dose if this was what she experienced after the first dose. It was reported that the patient went to emergency room. Relevant tests were none. Outcome of the events nauseated, headache, chills, tiredness, dizziness, weakness was not recovered; blood pressure was up was recovered on 24Feb2021; and other events was unknown. No follow-up attempts are possible; No further information is expected.
77 2021-04-24 tingling Tingling in my left hand; severe throbbing pain in my left arm; This is a Spontaneous report from a ... Read more
Tingling in my left hand; severe throbbing pain in my left arm; This is a Spontaneous report from a Contactable other HCP (patient, self-reported). A 77-years-old female patient (patient was not pregnant) received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247 and expiration dates were not reported), via an unspecified route of administration in left arm on 09Feb2021 at 17:30, as single dose for COVID-19 immunisation. The patient's medical history included allergy to amoxicillin. The concomitant medication included vitamins. On 11Feb2021 at 12:00 AM, the patient experienced tingling in left hand for 3-days still present time, 2nd day after COVID Vaccine she had severe throbbing pain in left arm and took tylenol-MAPP 650 Mg every 8 hrs. Also Ibuprofen 400MG 4-hrs after taking tylenol. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not take any other vaccine in four weeks. Patient took tylenol-MAPP 650 mg every 8 hrs and Ibuprofen 400mg as corrective treatment. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the events was considered as not recovered. No follow up attempts are needed. Information on Lot/batch can not be requested. No further information is expected.
77 2021-04-26 discomfort Client c/o sore LD. Minutes later c/o neck and shoulder pain. Nurse called EMT to do vitals on cli... Read more
Client c/o sore LD. Minutes later c/o neck and shoulder pain. Nurse called EMT to do vitals on client. Client also explained that she was very nervous. Vitals taken BP 129/69, HR 66, Resp 19. Recheck BP 131/73. Client advised level of pain/discomfort down and released.
77 2021-04-26 numbness Numbness and sensitivity on right side of face, nose, right nostril and upper lip; took Lyrica to se... Read more
Numbness and sensitivity on right side of face, nose, right nostril and upper lip; took Lyrica to see if this was a nerve issue; Numbness and sensitivity on right side of face, nose, right nostril and upper lip; took Lyrica to see if this was a nerve issue; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL7Z69 ; expiry was not reported) via an unspecified route of administration on 10Feb2021 as single dose for covid-19 immunisation (at the age of 77 years). The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness and sensitivity on right side of my face, nose, right nostril, and upper lip; and she took Lyrica (lot number: 19074111; Investigation Assessment: No) to see if this was a nerve issue and as therapeutic measures. She took a Lyrica this morning (12Feb2021) to see if this was a nerve issue and she took a Lyrica, Saturday as well. She was just checking to see if she had numbness and sensitivity on the right side of my face and the nose, the right nostril, and the upper lip of the mouth, was this a cause of the shot and is this the reason of Covid or not. The outcome of numbness and sensitivity on right side of face, nose, right nostril and upper lip; took Lyrica to see if this was a nerve issue was unknown. Information about Lot/Batch number has been requested.
77 2021-04-27 weakness, pain in extremity immobile for a day; cannot walk; sore arm; weakness; This is a spontaneous report from a contactable... Read more
immobile for a day; cannot walk; sore arm; weakness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 77-years old) (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. Medical history included Hashimoto's disease from an unknown date and unknown if ongoing, Diagnosed 35 years ago, hypermobility syndrome from an unknown date and unknown if ongoing, Diagnosed 20 years ago, "anomia" (unspecified) from an unknown date and unknown if ongoing, Diagnosed 25 years ago, and thyroid high from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) taken for thyroid disorder, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for thyroid disorder, start and stop date were not reported; and diazepam (VALIUM) taken for an unspecified indication, start and stop date were not reported. The patient experienced immobile for a day on an unspecified date, cannot walk from kitchen to the other room on an unspecified date, she is so weak which lasted one day and was bearable on 15Feb2021, and sore arm on an unspecified date. The patient underwent lab tests and procedures which included investigation: has antibodies, they are there but not very strong on an unknown date. The clinical outcome of the events immobile, gait disturbance and pain in extremity was unknown; asthenia was recovered on an unknown date Feb2021 (lasted one day). The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021409340 Same patient, different dose and event
77 2021-04-27 breast pain Mild sensation in left chest area and along left side neck, along with mild shortness of breath star... Read more
Mild sensation in left chest area and along left side neck, along with mild shortness of breath starting about 3/20/21 Has since disappeared. On or about 3/25/21 a hard, painful rash appeared on buttocks and has since healed. A second larger painful rash appeared in a different area on or about 4/5/21 and lasted about 2 weeks. Along with rash is tenderness of skin in surrendering area of rash, there is pain under breast area which extends to back and persists.
77 2021-04-28 weakness, pain in extremity could not walk or eat; could not walk or eat; sore arm; doctor took a test and the caller has antibo... Read more
could not walk or eat; could not walk or eat; sore arm; doctor took a test and the caller has antibodies and they are there but not very strong; anaphylactic reaction; excruciating pain in the body; felt like if her internal organ were shutting dow; was so weak her husband fed her and made sure she was drinking; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 08Mar2021 15:30 (3:30 PM) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included hashimottos (reported as hoshimottos) Diagnosed 35 years ago, hypermobile Diagnosed 20 years ago, and disorder nomia Diagnosed 25 years ago; all unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID); diazepam (VALIUM); and levothyroxine (LEVOTHYROXINE); all taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 on 15Feb2021 for covid-19 immunization first dose at the left arm and experienced immobile for a day, cannot walk, weakness and sore arm. The patient was to know if there is going to be a booster for the Pfizer covid vaccine. The patient stated she received the Pfizer covid vaccine both doses and she is calling to report the reaction she had with the first and second dose to help other patients, she said she was close to death after the second dose. In the middle of the night she was awaken due to excruciating pain in the body, like truck ran over her. The patient heard that someone had same reaction who was in the hospital, with similar symptoms to covid. She said she felt like if her internal organ were shutting down. She does not do well with the antibiotic, and does not go to the doctors. She could not walk or eat after the second dose. She said she has hashimoto dysautonomia hypermobility. she said she thinks she might have had anaphylactic reaction. The patient added that she has lived through it and her experience has been very unusual. The caller has underlying conditions that may have caused this event, she received the second dose on 08Mar2021, it was a horrible experience but since she is still alive she would want to report it. The caller does have strange reactions to chemicals and she typically goes to naturopaths and holistic doctors because of this. The caller also has multiple autoimmune disorders and feels like that may have played a part in this reaction. It was added that further added that she received her second dose 08Mar2021 at 3:30pm and had a little bit of a sore arm, she was thinking positive thoughts about all of this because she never gets vaccines. At 2:00am on 09Mar2021 the caller was awaken in excruciating pain, every surgery she has had or accident manifests in the greatest pain. The pain was excruciating the caller took over the counter pain medicine and diclofenac and it didn't help. The caller is unsure of what she took, she may be making this up. The caller felt like she was dying, she felt like her internal organs were shutting down, it happened all week. The caller was so weak her husband fed her and made sure she was drinking. The caller thinks she would die if she had to have a booster shot of this vaccine. The caller has never had anaphylactic shock, could this have been anaphylactic shock? All of the pain from a surgery all occurred at once and her entire body was wrecking, in horrible pain, that she does not think heroin could have taken care of. After the second vaccine she was literally so weak that she felt like all of her vital organs were shutting down and it lasted for 6 days, like she got hit by a truck, like had beat her up. The caller knows that there are new found reactions with (Company name) and they stopped thousands of doses because of it, she saw this in the news today. The patient wanted to make note that she has underlying autoimmune diseases, she is unsure if there is a correlation between this and her reaction. The caller was changing from her thyroid medicine and her thyroid went very high with the generic brand so she was swapped to Synthroid in the middle of this. The caller was on levothyroxine and it wasn't working, her thyroid was sky high (Unknown lot number and expiration date Feb2022). The caller was going through all of these changes as well when she received the vaccine. The caller's doctor took a test and the caller has antibodies and they are there but not very strong. The caller doesn't want to be spreading something because she is feeling healthy and fine today. The outcome of the events was unknown.
77 2021-04-28 pain in extremity After my 2nd shot on 2/17/21, my L arm hurt as with my first shot on 1/27/21. Similarly I took Tylen... Read more
After my 2nd shot on 2/17/21, my L arm hurt as with my first shot on 1/27/21. Similarly I took Tylenol. [And, very grateful that arm soreness was the only after-effect after 2nd shot.] [No arm soreness past a few days with 1st shot.] HOWEVER:10 WEEKS! after my 2nd shot on 2/17/21, my arm is STILL SORE. Advice has been: try heat, try ice, try movement, try stretching, try Voltaren [Diclofenac]... info from any doctor I could ask, from nurse help-line, any nurse or anyone who might have an answer. I TRIED EVERYTHING THAT WAS SUGGESTED, and soreness is still there. CAN YOU HELP??
77 2021-04-29 feeling of body temperature change, tremor, cold sweat Uncontrollable body shaking, high fever, cold and hot sweats, was not aware at times of where I was ... Read more
Uncontrollable body shaking, high fever, cold and hot sweats, was not aware at times of where I was or what day it was, my husband had to hold me to help stop the shaking.....NOT CHILLS, could not walk, diarrhea. This happened also on March 31st, my FIRST injection.....My heart was beating out of my chest.... very scary. Please don't tell me this is NORMAL!!! I've lost at least 5 lbs. I am petrified to get the booster, if there is one, I WILL NOT GET IT... ANY SUGGESTIONS.
77 2021-04-29 pain in extremity, numbness Patient presented with acute onset neck pain radiating into her arms bilaterally on 4/25. On 4/27 s... Read more
Patient presented with acute onset neck pain radiating into her arms bilaterally on 4/25. On 4/27 she acutely became paralyzed in her lower extremities and lose sensation over her abdomen completely and decrease sensation in her legs bilaterally. MRI confirmed large spontaneous epidural hematoma in cervical and thoracic spine.
77 2021-04-30 weakness sore throat; swollen glands; she said her throat felt swollen, and like it was closing up; Feeling u... Read more
sore throat; swollen glands; she said her throat felt swollen, and like it was closing up; Feeling unwell; Weakness; light headed/weak when standing up; polymyalgia; sick; This is a spontaneous report from a contactable nurse (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9284; Expiration Date: 31May2021), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 14:30 as single dose for covid-19 immunisation. Medical history included polymyalgia rheumatica, Giant Cell Vasculitis from 2020 (Verbatim: Giant Cell Vasculitis, Reported she started taking Prednisone about a year ago for Giant Cell Vasculitis. She said she started at Prednisone 60mg a day, and now is down to Prednisone 10mg a day), Congestive Heart Failure, COPD, Hypertension, Pulmonary Hypertension. There were no concomitant medications.The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1283, Expiry Date: 30Apr2021) on 21Jan2021 via Intramuscular, anatomical location was arm left, prednisone for Giant Cell Vasculitis (she started taking Prednisone (60mg a day)about a year ago for Giant Cell Vasculitis and was down to Prednisone 10mg a day.her side effects are not that bad. She said she just expected to feel better.), flu vaccine (She gets temperature 101 and sick from the flu vaccine, so she doesn't get the flu vaccine anymore and it had been quite a few years since she took the flu vaccine.), pneumonia vaccine (got a pneumonia vaccine about a year or so ago).On 12Feb2021, patient had been on the couch and watching television. She was fine laying down, but when she got up, she was lightheaded and didn't feel well and had weakness when she got up. Patient had a sore throat with swollen glands in her neck, her throat felt swollen and like it was closing up and glands started hurting on 15feb2021. She was sick when got up, but when lay down she was fine. she had polymyalgia was doing better before the vaccination. She was wondering if it was normal for the COVID-19 Vaccine side effects to last that long or were the COVID-19 Vaccine side effects expected to last that long. Wanted to know if because she was taking Prednisone, her COVID-19 Vaccine side effects were lasting longer. Patient stated she always thought she was 5'5", but the last time she was measured at the doctor she was told she was 5'. No further details provided. her shortness of breath is worse since she got the COVID-19 Vaccine. She said she was doing better before she received the COVID-19 Vaccine. She took 1 Tylenol on 11Feb2021 and again on 15Feb2021 (Lot Number: 06V1489, Expiration Date: May2022). She said she took 2 Equate Brand Tylenol 500mg tablets because her throat felt swollen, and the throat swelling went away on 16Feb2021. Patient had severe pulmonary hypertension until she had a cardiac catheterization. She said she was told from the cardiac catheterization that she had the potential for pulmonary hypertension but did not have severe pulmonary hypertension. She said prior to the cardiac catheterization she had years of cardia echos performed, and the cardiac echos were not correct. The outcome of the event throat felt swollen was recovered on 16Feb2021, for feeling unwell, lightheadedness, weakness it was not recovered and sore throat, swollen glands it was recovering.
77 2021-04-30 numbness, pain in extremity stroke caused by a blood clot; stroke caused by a blood clot; right arm went completely numb; She is... Read more
stroke caused by a blood clot; stroke caused by a blood clot; right arm went completely numb; She is tired; shortness of breath; her eyes were blurry; her head felt like somebody put a spike in it on the right side; sore arm; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06Feb2021 13:15 (Lot Number: EM9809) (at age of 77-year-old) as single dose for COVID-19 immunisation. Medical history included colitis ulcerative from Oct2020 (dropped weight, she dropped from 127 pounds to 109 pounds) , cardiac disorder, atrial fibrillation, and osteoporosis, all were ongoing. Concomitant medications included carvedilol taken for cardiac disorder, atrial fibrillation from an unspecified start date and ongoing; cyanocobalamin (VITAMIN B12) taken for cardiac disorder from 2018 (reported as has taking it close to 3 years) and ongoing; denosumab (PROLIA) taken for osteoporosis from an unspecified start date and ongoing; ubidecarenone (Q10) taken for cardiac disorder from unknown start date and ongoing; calcium, colecalciferol (CALCIUM + D3) taken for osteoporosis from 2020 (reported as a year ago) and ongoing; influenza vaccine (FLU VACCINE VII) taken for an unspecified indication, start and stop date were not reported, and vitamins NOS (MULTIVITAMIN) from an unspecified start date and ongoing, the patient started taking it when she was a senior in high school and stated because she is not the best eater in the world. There was no prior vaccinations (within 4 weeks). AE(s) following prior vaccinations: The patient stated arm is sore with flu shot and probably did when she was little when she got the loaded shot, the mumps one. She wouldn't remember that because she was little. The patient experienced stroke caused by a blood clot on 20Feb202114:30 with seriousness criteria hospitalization, sore arm on 07Feb2021, and right arm went completely numb, tired, shortness of breath, her eyes were blurry, her head felt like somebody put a spike in it on the right side on an unspecified date. The event stroke caused by a blood clot result in emergency room visit.The patient was hospitalized for stroke caused by a blood clot from 23Feb2021 to 24Feb2021. The patient reported that she received the first dose and she is thankful she got it on 06Feb2021 and the only side effect she had was a sore arm. Stated on 20Feb2021 she had a stroke caused by a blood clot obviously, she ended up in the hospital. She didn't think at the time, doesn't fault the physicians that took care of her. She didn't think it was related and her eldest son thought it was related. The patient stated they thought it was a mild stroke and after they did the C scan the neurosurgeon, while she was lying in the hospital bed, looked at her assistant and said he couldn't believe that she was talking and walking. The patient stated part of it was ignorance on her part, everyone thought it was the left side that numbs, but hers was the right side. Stated she didn't fall, she dropped something and went down to get it and her right arm went completely numb and she couldn't get back up and she tried to push with legs and couldn't get up. Stated all of a sudden her eyes were blurry and then she never gets headaches and her head felt like somebody put a spike in it on the right side, stated it is supposed to affect the left side. stated she has a heart problem. The patient stated she had a sore arm for about a week, lasted for a few days. stated she gets a sore arm with the flu shot. stated when she would roll over to lay on her left side and roll over on that arm it was enough to wake her up. stated it lasted about 5 days. She couldn't figure out why it was lasting so long. Stated the second thing that happened was that she went to her son's home that night for dinner, hadn't told him about it and while she was eating dinner she asked am if she leaning to the left and he said yes, she was and that her words were being slurred and only lasted for about 10 mins. Stated she didn't call and ignorance is unreal with this stuff. She went to urgent care the next day and they didn't call the ambulance. When she went to the doctor on 23 Feb2021 she was sent immediately to Hospital so she could go through the ER and that's when the neurosurgeon became involved. Stated right now her balance isn't quite right but she is driving and she was taking care of herself and they didn't send anyone home to help her. She was not having any problem talking. Stated she was not going to get into this and will beat it and get back to normal. She was tired a lot, which they said it's normal. Stated she was a real dynamite. Stated it is improving slowly, she was extremely tired and not taking her long walk like she was used to and has shortness of breath, she was not trying to over do it. Stated she always gets a sore arm with the flu shot. Stated her pain level is lower than most people. The patient stated the sore arm started late evening but the next day was really hurting and the main thing was rolling over. The patient stated she didn't take anything for her sore arm, she won't even take an aspirin because some of these Advil medications will mix with the heart medications. Stated in the hospital they were giving her medications she had through an IV in her arm but doesn't know what was going through that. Stated they put her on a blood thinner and they were testing the blood thinner through the IV. She was so miserable, she just wanted to go home and get a good nights sleep. Stated they took all kinds of test, checked her oxygen and had to have a certain number before she could go home. The patient received treatment for event stroke caused by a blood clot and not received treatment for sore arm . The outcome of events stroke caused by a blood clot was resolving, of event sore arm was resolved on 12Feb2021, of other events was unknown.
77 2021-05-01 burning sensation Burning back pain in the first lumbar dermatome distribution starting on 3/10. Drop attack on 3/17 ... Read more
Burning back pain in the first lumbar dermatome distribution starting on 3/10. Drop attack on 3/17 leading to Hospital admission 3/17. Episodic acute confusional state leading to readmission to Hospital 3/24 A clinical diagnosis off absence seizure made prompting beginning Keppra with no further episodes of seizure The Neurologist as noted above
77 2021-05-01 facial pain 4/6/21: Woke up in pain on left side of face and cannot swallow 4/10/21: Went to fast med with a swo... Read more
4/6/21: Woke up in pain on left side of face and cannot swallow 4/10/21: Went to fast med with a swollen lympth node on the left side of jaw. MD stated there was an infection and prescribed Augmentin for 14 days. 4/23/21: back to fast med. Still has no healed and was prescribed Doxycycline for `14 days 4/26/21: Patient developed a vaginal itch and raw legs * Stated had a headache during this whole duration
77 2021-05-04 pain in extremity SWOLLEN LYMPH NODES in Right armpit. Still have the swollen lymph nodes today 5/5/2021, almost 2 mon... Read more
SWOLLEN LYMPH NODES in Right armpit. Still have the swollen lymph nodes today 5/5/2021, almost 2 months. Frightening. Swollen under left eye 3/9/2021 to 3/11/2021. Upper back of both legs painful 3/9/2021. Still have this today 5/5/2021, almost 2 months. Sore at injection site 3/8/2021. Fatigue 3/9/2021.
77 2021-05-06 numbness Right eye pain with tenderness and blistering around the eye. Nose numbness on the right side of nos... Read more
Right eye pain with tenderness and blistering around the eye. Nose numbness on the right side of nose and around. Top of head sensitive. She went to the ED, which diagnosed shingles and referred her to the eye doctor. Prescribed 10 days of Valcyclovir, erythromycin opthalmic ointment, and prednisolone opthalmic suspension. Symptoms lasted the month of April.
77 2021-05-10 pain in extremity sore arm; chills; exhaustion so bad it almost bordered nausea; This is a spontaneous report from a c... Read more
sore arm; chills; exhaustion so bad it almost bordered nausea; This is a spontaneous report from a contactable consumer or other non-HCP. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9264), via an unspecified route of administration in left arm on 04Feb2021 at 07:00 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 04Feb2021 at 22:00, the patient experienced sore arm, chills, and exhaustion so bad it almost bordered nausea. The patient did not receive any treatment for the adverse events. The outcome of events was recovered.
77 2021-05-12 feeling hot, weakness Fatigue extreme; Not want to eat breakfast, did not have energy just wanted to sleep/ feel very wea... Read more
Fatigue extreme; Not want to eat breakfast, did not have energy just wanted to sleep/ feel very weak; Dizzy; Spinning around like in a tunnel/ Vertigo; Had like 4 attacks a day and I did not hold down laying in bed and looking up ceiling and ceiling starts spinning; Frightening; little warm in the arm; Resting heart rate but the oxygen was running low it was like 84-80; I don't feel good;; Hit me like a rocket; This is a spontaneous report received from a contactable consumer (Patient) via a Pfizer Sponsored program. A 77-year-old female patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not Reported), via an unspecified route of administration on 16Feb2021 as single dose for COVID-19 immunisation. edical history included ongoing hypertension, ongoing COPD (chronic obstructive pulmonary disease) and ongoing acid reflux. Concomitant medication included metoprolol succinate at 50 mg, once a day for hypertension, alprazolam (XANAX) at 2.5 DF, twice a day for anxiety, albuterol at Every 3 to 4 hours as needed for chronic obstructive pulmonary disease, budesonide at 5 mL, twice a day for chronic obstructive pulmonary disease, arformoterol tartrate (BROVANA) at twice a day morning and night for chronic obstructive pulmonary disease, tiotropium bromide (SPIRIVA) Inhaled through the mouth, once a day as a bronchodilator, aspirin, omeprazole (PROTONIX) at 40 mg, once a day for Acid reflux, diltiazem at 300 mg, once a day for hypertension and unspecified vitamins. Patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization received on 26Jan2021 and experienced warm arm. It was reported that, the patient had a very bad experience with the shot. On Tuesday in this rehabilitation, they were giving out the shot, this was her second shot in this place. The first shot she had no reaction, just a little warm arm. On an unspecified date in Feb2021, the second hit her like a rocket, the day after the shot or the day over the shot just a little warm in the arm nothing really, the next day woke up extremely fatigued did not even want to eat breakfast did not have the energy just wanted to sleep and she said what was going on with her and then she got up very fatigued. Then the physical therapist came in to give physical and they "supposed to" (not clarified) her. It showed a good blood pressure everything was good resting heart rate, but the oxygen was running low it was like 84-80 and she knew she was because she could feel it while she was walking and patient told them she does not feel good, she felt very weak and thought it must be from the shot. So that went on then and go on to this same thing very dizzy on the next day of second shot on 17Feb2021, spinning. That day spinning around in like a tunnel. She had like 4 attacks a day and she did not hold down that she was laying in her bed and she was looking up in the ceiling and this ceiling starts spinning with the whole room. That was 4th of those on Thursday, Wednesday she was just tired, Friday she had less of them but the same thing spinning around, never fell down but again it was not while she was standing up. The physical therapist said to her sit up do not lay down in the bed. Now she was taking pulmonology medication through a nebulizer. Patient also taking bronchodilator and she take a prednisone pill 20 mg, albuterol and she take other medication. Patient did the Covid test when he had blood work up. They do a blood work up every 2 weeks here. But everything was good. The outcome for events was reported as unknown. Information about lot/batch number has been requested.
77 2021-05-14 electric shock sensation felt like I got hit by an eletric shock in my heart going to my neck and left arm lasted 2 seconds; ... Read more
felt like I got hit by an eletric shock in my heart going to my neck and left arm lasted 2 seconds; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non-pregnant female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via an unspecified route of administration in left arm on 13Feb2021 at 11:00 (at age of 77-year-old) as 2ND DOSE SINGLE for COVID-19 immunization. The patient medical history includes AAA Aneurysm, Osteoarthritis, Costochondritis from unspecified date. The patient concomitant medications include losartan, carvedilol, ezetimibe, ascorbic acid vitamin D, Curcuma longa (TURMERIC) from unspecified date and unknown if still ongoing. Patient had allergic to penicillin and ciprofloxacin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), Lot number & Expiry date not reported) via unspecified route of administration in left arm on 23Jan2021 at 11:00 as single dose for COVID-19 immunization. On 14Feb2021 at 13:00 (one day after vaccination) Patient experienced she felt like got hit by an electric shock in my heart going to my neck and left arm lasted 2 seconds. No treatment was received by patient. The outcome of event was recovered. Information on the lot/batch number has been requested. No further information expected.
77 2021-05-17 facial pain April 14 pain in side of face; next day watery eye and rash above eye. Clariton D and advil helpful;... Read more
April 14 pain in side of face; next day watery eye and rash above eye. Clariton D and advil helpful; April 27th am pain on top of left side of head and face and over eye. Urgent care diagnosis shingles with eye complication; ER tested and then treated me for shingles. One week anti viral with f/u with ophtalmalogist and internist. Antiviral extended one more week and cortisone and triple for eye area. I am still doing the lotion treatment and have gone back to eye doc twice and tomorrow again. Tylenol 3 time a day. I have since come down with a cold but getting over that. It appears pfizer vacine has weakened my immune system for these other diseases.
77 2021-05-17 pain in extremity feeling a little weird; Nauseous; Headaches; blood pressure went up over 220; pulse rate went way up... Read more
feeling a little weird; Nauseous; Headaches; blood pressure went up over 220; pulse rate went way up; really ill; memory is a little off right now; felt like I am going to faint; ringing in the ears; dizzy/light headed; a really really sore arm for two days after the vaccine; allergic reaction; This is a spontaneous report from a contactable consumer, the patient. This 77-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171), via an unspecified route of administration on 29Apr2021 (at the age of 77-year-old) as a single dose for COVID-19 immunization. Medical history included allergies and sinus headaches which she takes (Excedrin) off and on for years in the past, and high blood pressure. Concomitant medications included atenolol (manufacturer unknown) taken for hypertension, start and stop date were not reported. Past drug history included the patient received a flu shot (unspecified Flu shot) with a mega reaction she was sick for weeks which was at least probably 15-20 years ago So, she never got a flu shot after that and she has never had the flu. On 29Apr2021, the patient had a really really sore arm for two days after the vaccine, dizzy/light headed, felt like I am going to faint, and ringing in the ears. On an unspecified date in 2021, she experienced allergic reaction. On 01May2021, she was really ill, and her blood pressure went up over 220 and pulse rate went way up. On 02May2021, she experienced headaches. On 06May2021, she was feeling a little weird and nauseous. On an unspecified date in May2021, her memory is a little off right now. The clinical course was as follows: the patient reported, "I had a really really sore arm for two days after the vaccine, it's okay now, I couldn't really move it. I feel I may be having a severe allergic reaction to the Pfizer vaccine (Pfizer Covid-19 Vaccine) got on Thursday (29Apr2021) of this past week. I am very light headed, dizzy and felt like I am going to faint, has ringing in the ears, and all that has been going on about a week, since last Thursday (29Apr2021). Then I was really ill last night (01May2021). It started last night when we went to bed around 11 O'clock. I have never had anything like this in my life. My blood pressure was through the roof. With a blood pressure cuff and a stethoscope, her blood pressure went up over 220 which was so high that had never happened before, so I took an extra pill (atenolol 25 mg tablet) last night (01May2021) which helped a little bit but not enough, and I really thought that I was going to pass out and be really sick. Because I thought that it was either having a stroke or a heart attack, my husband had to call ambulance to take me to the hospital last night. The systolic and diastolic and pulse rate went way up. They did chest x-ray, blood work, and urinalysis, and everything came back fine and they could not find anything. They just felt that I was just having a major reaction to the shot so they sent me home. I just got home this morning (02May2021) from having to go to the emergency room. But as soon as we got home, I started with a humongous headache and so I had Excedrin/Tylenol for headaches because I used to get sinus headaches. So, I took that, and it helped a little bit, my headache got a little better. Anyhow, I am much better right now and I am sleeping. But tomorrow it will be the same." Later the patient also reported, "Today (06May2021) I am feeling a little weird with ringing of ears and is light headed sometimes. Because of the light headedness, I feels a little nauseous. But I am a still very nauseous. I feel like I am going to faint again and my blood pressure I think has gone back up. I am trying to keep calm and trying to figure out what is going on. But I am really afraid if I am having a reaction to the vaccine unfortunately. I am dizzy and I do not want to start getting worst again. I guess I will feel better if you tell me that this happens sometimes and what can I do to decrease somehow?" She also stated that she did contact her doctor about this event but she didn't get very far. Her memory is a little off right now because she really has not felt well. She stated that her biggest thing is her blood pressure. She also stated, "The only thing that I am really concerned now is about getting the second shot because I already had the reactions by the first shot. Am I going to face the same thing or even the worse with the second shot?" Treatments were received for her blood pressure went up over 220 and headaches. The clinical outcomes of the event "a really really sore arm for two days after the vaccine" resolved on 01May2021, the event nauseous was not resolved, while the events, allergic reaction, really ill, felt like I am going to faint, pulse rate went way up, ringing in the ears, dizzy/light headed, Headaches, feeling a little weird and memory is a little off right now were unknown.
77 2021-05-19 concussion became extremely dizzy; when I came home and passed out.; Hit my head on floor; received a concussio... Read more
became extremely dizzy; when I came home and passed out.; Hit my head on floor; received a concussion; cut on scalp; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 15Mar2021 13:45 (at the age of 77-year-old) (Batch/Lot Number: en6205) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included atorvastatin; furosemide; and calcium. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: el9265), administered in left arm on 22Feb2021 at 02:30 PM (at the age of 77-year-old) for COVID-19 immunisation. On 15Mar2021, the patient became extremely dizzy when she came home and passed out. She hit her head on floor and received a concussion and cut on scalp. The events caused hospitalization for 2 days. The patient was tested for COVID post vaccination via nasal swab on 22Apr2021 which was negative. Therapeutic measures were taken as a result of all events which includes computed tomography (CAT) scan and electrocardiogram (EKG) with unknown results. The patient recovered from the events on an unspecified date.
77 2021-05-19 pain in extremity Nausea; fatigue; sore arm; vertigo; This is a spontaneous report received from a contactable consume... Read more
Nausea; fatigue; sore arm; vertigo; This is a spontaneous report received from a contactable consumer, the patient. A 77-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: unknown) via an unknown route of administration on 09Mar2021 at 03:00 PM (at the age of 77-years) for COVID-19 immunisation. On 09Mar2021 at unknown time, the patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: not provided) via an unknown route of administration for COVID-19 immunisation. Medical history includes osteoarthritis. The patient was allergic to darvon. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient experienced nausea, severe fatigue, vertigo and sore arm on 09Mar2021 at 03:00 PM, which were intense for 24 hours then intermittent for 6 days. No therapeutic measures were taken as a result of these events. On an unknown date, the patient was recovered from the events nausea, severe fatigue, vertigo and sore arm. Information about lot/batch number cannot be obtained. No further information is expected.
77 2021-05-25 pain in extremity 5:42 PM Note Telephone call with patient, she has been sick with intermittent fever, runny nose, ... Read more
5:42 PM Note Telephone call with patient, she has been sick with intermittent fever, runny nose, back pain and leg pain for the past week. Does not seem to be getting any better but also not getting any worse. She has a procedure that is supposed to be done on 4/30. Patient states that she did have her 2 Covid vaccinations and the last vaccination was 5 weeks ago. She plans on canceling the procedure. Care Coordination Progress Note RN (Registered Nurse) COVID 19 Infusion Navigator Post Infusion Outreach #1 Infusion Date: 4/30/21 Medication ? bamlanivimab/etesevimab ? casirivimab ? bamlanivimab
77 2021-05-26 muscle spasms Jaw pain up into eye; lymph nodes in the neck that made her hard to move her head; leg cramps; sleep... Read more
Jaw pain up into eye; lymph nodes in the neck that made her hard to move her head; leg cramps; sleepy; palpitations; My chest has been beating like a 107 and it is normally like in the 70/Fast heart beat; lymph nodes in the neck that made her hard to move her head; I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help; I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; she was sneezing; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205, Expiry Date; UPC and NDC number: Unknown), via an unspecified route of administration on 26Feb2021 01:00 PM in the right arm at 1ST DOSE, SINGLE for COVID-19 immunisation. Patient's age at vaccination was 77 Years. Medical history reported as, the patient first states that she was medication free, but then clarifies that she does takes a vitamin D that is prescribed by her doctor. She had a lot of allergies when she was very young, she was tested for allergies. Two years ago she didn't think she was sick but her calcium was high, she had 2 parathyroid glands removed and she was stronger than she was before. She takes no pills for it, she has nothing wrong with her, outside of the cancer she had when she was 55 years old. Caller reported that the injection did not hurt for either herself or her husband, and it was wonderful. The patient states that she had no fever or chills from the vaccine, but both the caller and her husband were tired after receiving the vaccine, but caller thought it was from stress. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included an unknown vaccine and patient states as, that back a long time, when she was a youngster, when she was given whatever vaccination is needed to go to school, her arm swelled past her elbow, and she was sick for a few days. Caller does not remember which injection it was, it was whatever injection she had to have to go to school, she was 5 years old. Caller doesn't recall the name of the injection. No prior vaccinations (within 4 weeks). The patient states that she does not take the flu shot or anything like that, ever. Vaccination facility was reported as outside the distribution center in the parking lot. On an unspecified date in Feb2021, the patient experienced My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose, lymph nodes in the neck that made her hard to move her head, I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help and she was sneezing; On 26Feb2021, experienced my chest has been beating like a 107 and it is normally like in the 70/Fast heartbeat, sleepy, palpitations; On 01Mar2021, experienced leg cramps; On 03Mar2021, experienced lymph nodes in the neck that made her hard to move her head; On 04Mar2021, experienced Jaw pain up into eye. The report received as, the patient was pleased where she had the injection it didn't have swelling or get red and she does have a history of allergies and her doctor said it was ok to get the shot. The doctor told her, that if she had any eye tearing, nasal drip, or other things like that, to take a Benadryl. Caller waited 12 hours, because her eyes did start to tear, and she was sneezing and so she took a non-drowsy Benadryl, but she waited 12 hours to take the Benadryl, because she didn't want it to interfere. The patient experienced fast heartbeat started in the evening on the same day. Patient also had fast heartbeat yesterday. She reports she had a fast heartbeat; it was in the low 90s, she knows that's not fast for some people, but it was fast for her, and it would come and go like palpitations. Patient does have a machine, her heartbeat was in the 90s, and her chest has been beating like a 107 and it was normally like in the 70s. Caller was in the kitchen when she felt it, so she sat down. The patient reports that she has not experienced the palpitations today. The patient states that she was doing something in the kitchen, she's very active. She normally gets up in the morning and does the breast stroke for 1.5 hours, and patient states that she only got up to the pool once this week, and she didn't stay at the pool long because of the leg cramps. The patient reports she did have a fast heartbeat yesterday. The patient reports that she also started to have a lot of cramps in her legs, which she has never had before in her life. The patient states that 2 days ago, the lymph nodes in her neck must have been swollen, and it hurt so bad last night, she didn't know what to do, she took regular over the counter Tylenol and it did help. The patient states that it's not bothering her today. it's right down the sides of her neck. She looked on the internet for lymph nodes in neck, she knew she had lymph nodes in her neck and it was really, really tight. It was both sides of her neck. It's not as bad today because she couldn't stand it anymore last night so she could take Tylenol. She was to a point sitting in a chair, how could she stretch her neck because it hurt so bad. But this morning she can move it pretty good. She told her husband if it continued that she would go to hospital. She was concerned with if she should get the second shot or not. She was wondering did the first Covid shot cause this. She did take Tylenol this morning, she also reports jaw pain and up into her eyes, that started yesterday, and it has been relieved. She's concerned if she got this with the first shot, could she get it with the second which was scheduled on 19Mar2021, and she was a little doubtful about getting that second shot. The patient states that she was very seriously thinking of not getting the second shot, because she had an awful lot of discomfort with this first shot. The patient states that it wasn't that she was tired, she was just sleepy, she was sleepy on the day she got the vaccine, and then on Saturday, 27Feb2021 she had 3 naps, then on Sunday, 28Feb2021 she had 2-3 naps. Then on Monday, 01Mar2021 she was back to normal. The only things caller was concerned about was if she should get the second shot. She read about not getting the second shot if you had a fast heartbeat. She would call her doctor, but all the doctors are telling people to get the shot. The only reason she got it was because of her husband and his underlying conditions. No specify Antipyretic used around the dates of Vaccination. No relevant tests. The patient underwent lab tests and procedures which included Heartbeat: 107, 90s on 26Feb2021. Outcome of the event lymph nodes in the neck that made her hard to move her head was recovering; events palpitations, jaw pain up into eye recovered on an unknown date; event leg cramps recovered on 03Mar2021 and outcome for remaining events was unknown. No follow-up attempts are possible. No further information was expected.
77 2021-05-28 weakness headache; low energy; body aches; This is a spontaneous report from a contactable consumer (patient)... Read more
headache; low energy; body aches; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EN6203, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 26Feb2021 at 11:00 am (age at vaccination was 77 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history included atrial fibrillation and high blood pressure. The patient did not have any allergies. Concomitant medication patient received within 2 weeks of vaccination included rivaroxaban (XARELTO), nebivolol hydrochloride (BYSTOLIC), atorvastatin and amlodipine besilate, olmesartan medoxomil (OLMESARTAN E AMLODIPINA EG). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EI9265, Expiration Date: unknown) via an unspecified route of administration, administered in left arm on 05Feb2021 at 11:00 am (age at vaccination was 77 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. On 27Feb2021 at 19:00 pm, the patient experienced headache, low energy and body aches. Today on 01Mar2021, 3 days after second dose patient was still experiencing headache, low energy, and body aches. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unknown date. The patient received treatment with Tylenol Extra Strength. The outcome of events was not resolved. No follow-up attempts are needed. No further information is expected.
77 2021-05-28 muscle twitching tiredness; nausea; whole body was twitching; This is a spontaneous report from a contactable consume... Read more
tiredness; nausea; whole body was twitching; This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced tiredness, nausea and whole body was twitching. The outcome of the events was unknown. This Follow-up is being submitted to notify that lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed. No further information is expected.
77 2021-05-31 tingling, numbness Caller had noticed numbness around the life side of her body including the left hand and fingers; Ti... Read more
Caller had noticed numbness around the life side of her body including the left hand and fingers; Tingly from her scalp to the bottom of her foot; Numbness around the life side of her body/The entire left side of her body, unilaterally, went numb; This is a spontaneous report from a contactable consumer. A 77-year-old female consumer received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration on Arm left on 23Jan2021 (Batch/Lot number: EL3249), as 1ST DOSE, SINGLE for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient reported, she noticed numbness around the left side of her body including the left hand and fingers. The fingers are more numb than any other part of the body on 23Jan2021. She states My doctor thinks it's some kind of a vascular or neurological event. He doesn't recommend the second dose. I want to know if these side effects were associated with the vaccine. The entire left side of her body, unilaterally, went numb and tingly from her scalp to the bottom of her foot. It was first noticed in the hand. She called (Emergency number) as she feared a stroke. They said it was not a stroke. Her hand is still considerably dumb and she has lost some of its use. This occurred approximately 7 hours after getting the vaccine. It has improved. Everything is back to normal besides her left arm from where she got the injection leading down to her hand. Her hand is the worst. The outcome of the events for numbness in hand was unknown and for rest of event it was resolving. Follow-up attempts are completed. No further information is expected.
77 2021-06-01 breast pain, pain in extremity headache; tiredness; got sleepy; felt a little bad; cysts bleeding; breast pain; knot in the vaginal... Read more
headache; tiredness; got sleepy; felt a little bad; cysts bleeding; breast pain; knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful; cysts in the rectal area; rash on her face and it's itching/ rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear; soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 12May2021 11:30 (Batch/Lot Number: EW0168) as 1st dose, single for covid-19 immunisation. Medical history included acne and migraine. The patient's concomitant medications were not reported. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 12May2021, patient experienced soreness in arm. On 13May2021, she had symptoms of rash on her face and it's itching, and the rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear. She could see all the pimples on the face so she put hot water on it and used rubbing alcohol, which she thought would help curb the itching and dry it up, the bottom of the ear lobe is very much active going into jaw area still. She also had headache, and tiredness following her dose, the doctor told her if headache was severe, take a Tylenol with codeine, she took something with codeine and it went away after about three hours. She also had some breast pain (only in the enfold of her breast closest to the middle of her chest), sore to the touch, and it was very sore for about 24 hours, and that it hasn't fully resolved. Then, while bathing, she noticed a knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful, large, and the size of a quarter, if she push on the pelvic bone area, it would be painful. Also, while bathing, she identified cysts in the rectal area; after bathing she was trying to identify what they were, when she touched it, it hurt, it felt like a ball and eventually it went down and she caused them to bleed, not a lot of blood, just a small amount. She also started getting more growths in the vaginal area/bottom area near the rectum. Patient got sleepy and now made herself go lay down and she doesn't usually do that. She felt a little bad, she didn't think it was severe side effects, she knew things were going on that she could pinpoint to what would possibly happen but not these cysts. She was recently seen by her gynecologist, a week ago, and none of these problems were apparent at that time. No Emergency Room or Physician Office visit. Patient had blood work done on 07Apr2021 and 10Apr2021 before the vaccine. The outcome of cysts bleeding and soreness in arm was recovered on 13May2021, itching rash, breast pain, painful knot, cysts in the rectal area was recovering, headache was recovered, other event outcome was unknown.
77 2021-06-01 face paralysis I63.9 - CVA (cerebral vascular accident) (CMS/HCC) R29.810 - Facial weakness
77 2021-06-01 cold extremities, pain in extremity a terrible time sleeping; feet and hands were ice cold; chills; coughing; sneezing; blowing her nose... Read more
a terrible time sleeping; feet and hands were ice cold; chills; coughing; sneezing; blowing her nose; Felt like she wanted to vomit; Felt short shots in her heart and lungs; Felt short shots in her heart and lungs; Can't eat much food; Feels an erratic short pain on right side of head; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; very bizarre dreams; pains underneath her arms; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 01Feb2021 (at the age of 77-years-old) as 2nd dose single for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient experienced a, had to use tons of blankets to get warm, very bizarre dreams (bizarre experience), pains underneath her arms. On 01Feb2021 experienced terrible time sleeping, feet and hands were ice cold, chills, coughing, sneezing, blowing her nose, felt like she wanted to vomit, felt short shots in her heart and lungs, cannot eat much food, feels an erratic short pain on right side of head. Got the second Pfizer shot on Monday (01Feb2021). Patient was seeing dreams and wild things. Woke up yesterday (02Feb2021) morning and it seemed to dissipate by yesterday noon time. Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people. Clarified she is referring to the COVID-19 shot. The patient agreed that experienced these symptoms after receiving the second dose of the Pfizer COVID-19 vaccine and they lasted about 24 hours and today patient feels fine. The reporter was concerned that patient may have had COVID, possibly from the vaccine, and wants to know if she was contagious. It was queried if patient had a positive COVID test after receiving the second COVID-19 shot. Patient did not address question and stated she only received the first and second COVID-19 shot. The outcome of the events suspected COVID-19, drug ineffective, pain in extremity, abnormal dreams, sleeping disorder was unknown while for the other events was recovered on 02Feb2021. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
77 2021-06-02 tenderness, pain in extremity tenderness in her left arm; mild pain in the arm; This is a spontaneous report from a contactable co... Read more
tenderness in her left arm; mild pain in the arm; This is a spontaneous report from a contactable consumer or other non health care professional. A 77-years-old female patient received bnt162b2 (BNT162B2PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6200, Expiration Date: Jun2021), dose 1 via an unspecified route of administration, in Arm Left on 23Feb2021 (at the age of 77-years-old) as 1 ST DOSE, SINGLE (0.3MCG/0.3m) for Covid-19 immunisation. The patient medical history included seasonal allergy. The patient concomitant medications were not reported. It was reported that, the patient received the 1st dose of the vaccine on 23Feb2021 and experienced nothing more than a little tenderness in her left arm where she gets the shot. She stopped taking her daily Claritin for her seasonal allergies to Tree pollen a day before getting the vaccine until now because she has read on an article and hear on the news that it was not recommended to take antihistamines during Covid19 vaccination. She is due for her 2nd shot on 16Mar2021. She had her first dose but having a minor allergy and tenderness on her arm. she stopped taking the generic Claritin, loratadine 10mg a 24hr antihistamine, takes for allergy to tree pollen that is picking up and affects her year-round, has never had a serious reaction to anything. The patient is asking when she can resume her Claritin and it was reported that if taking the Loratadine 10 mg tablet for her preexisting allergy which she last took on a day before she got her first dose of Covid-19 vaccine on 23Feb2021 can affect the efficacy of the vaccine. Patient also said that she felt mild pain in the arm after she got the first dose of the vaccine which according to her is nothing much serious. The outcome of the events was unknown. Follow-up(02Mar2021): New information received from a contactable consumer. Which includes: The event (she felt mild pain in the arm) was updated and clinical information added. No follow-up attempt is possible. No further information is expected.
77 2021-06-03 seizure like phenomena R56.9 - Seizure-like activity (CMS/HCC)
77 2021-06-04 tingling Hyperoxia; could not move her body or a finger or anything; Her arm was starting tingling; Tiredness... Read more
Hyperoxia; could not move her body or a finger or anything; Her arm was starting tingling; Tiredness for a few days after second shot; she was frozen; Blood oxygen level was at 163; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 77 years old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiry date were unknown) via an unspecified route of administration, administered in left arm on an unknown date at 10:45 AM (3 weeks after 1st dose) as 2nd single dose for COVID-19 immunisation. The patient received glycopyrrolate (batch/Lot Number and expiry date were unknown) via unspecified route of administration on an unknown date at a dose of 2 mg tablets daily (once daily in the morning) orally for peptic ulcer. The patient stated that she guesses glycopyrrolate would be expired when the 30 days are up. The patient did not have glycopyrrolate during reporting. The patient had just called the office and ordered a new refill when the freezing thing started. The patient was blind, so she could not read the label and batch number. The patient medical history included blindness called retinitis pigmentosa, diagnosed at 43 years old, she did not take anything for retinitis pigmentosa and it was genetic, ongoing and low thyroid (for several years). Family Medical History was mentioned as none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were unknown) via an unspecified route of administration in left arm in Jan/Feb2021 at 10:45 AM. The patient's concomitant medications included unspecified thyroid medications (for several years) and unspecified sleeping pill daily. On 25May2021 at 08:45, the patient went for her physical exam, the patient's blood oxygen was up to 163. The patient added high blood oxygen levels could affect the heart. The patient never had blood oxygen over 98. The consumer clarified she meant low oxygen and not low blood pressure. The patient had the writing on the tape recorder. Recorder spelled the term as Hyperoxia. The patient stated that a week and a half ago, she was sitting in a chair after both of her vaccines but that she started those pills again and felt tired. Tiredness was first noticed after second shot that evening and it lasted for some days. She was taking a nap while watching tv and that lasted couple of days. She would be tired and then have to take a nap, but did not feel bad. The patient sat in the recliner and went to sleep and when she woke up, she was frozen and could not move her body or a finger or anything. She went in around 1400 and had no idea how long she was asleep but her mind was working. The patient stated she told herself to concentrate and to move but could not. She had no idea how long she was in that state but kept concentrating on trying to move a finger and was able to get a finger to move. Her arm was starting tingling like when it falls asleep and she was just cautious when she finally got up to walk. The patient did not visit emergency room/physician office. The patient told that she did not feel this bad before the vaccines and that was why she thought it was the medication (glycopyrrolate) that caused it. The patient started back taking the medication a few weeks after and did not know what it was for and that was why she thought it was this medication. The patient underwent lab tests and procedures which included high oxygen level 163 on 25May2021 and blood pressure was 133/64 on an unknown date. The outcome of the event blood oxygen was up to 163 was not recovered, Hyperoxia, could not move her body or a finger or anything, Her arm was starting tingling, she was frozen was unknown, Tiredness for a few days after second shot was resolved. Information on Lot/Batch number has been requested.
77 2021-06-09 weakness weakness; muscle pain; tiredness; has not been feeling well; headache; nausea; vomiting; some diffic... Read more
weakness; muscle pain; tiredness; has not been feeling well; headache; nausea; vomiting; some difficulty with breathing; This is a spontaneous report from Medical information team. A contactable consumer (patients daughter) reported that a 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on 01Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 Immunization. It was reported patient experienced side effects include, weakness, muscle pain, tiredness. Her mother has not been feeling well. She does not feel 100% today. She was calling to see if these symptoms are related to the shot. Her mother has experienced tiredness, headache, muscle pain, nausea, feeling unwell, vomiting, some difficulty with breathing. She was sitting up currently and was fine but was not 100%. She also has weakness. Outcome of the events was unknown. Information about batch/lot number has been requested.
77 2021-06-09 numbness and pain in extremities, pain in extremity, muscle spasms Benign Essential Blepharospasm; her eyes were red and irritated when she was in for her treatment; h... Read more
Benign Essential Blepharospasm; her eyes were red and irritated when she was in for her treatment; her eyes were red and irritated when she was in for her treatment; Her vision was blurry; white circle around the cornea; difficulty swallowing; exhausting; end of her fingers and toes are still hurting and feel frozen; end of her fingers and toes are still hurting and feel frozen; slow abnormal blink. Very slow blink; Neuropathy felt worse; Neuropathy felt worse; Her eyes were extremely sensitive to light./She couldn't open her eyes; muscle spasms in right arm and under right breast and going across her stomach and in legs at times; muscle spasms in right arm and under right breast and going across her stomach and in legs at times; Left arm hurting; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (Lot number: EN6201), via an unspecified route of administration, administered in arm left on 19Feb2021 09:30 (at the age of 77-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included multiple myeloma from 2017, fibromyalgia, Raynaud's phenomenon, neuropathy all was ongoing; Bone and blood transplant 3 years ago in 2018, pain, sleep disorder, herpes, cancer, dry eyes, and fungus from the pneumonia. Concomitant medications included ongoing gabapentin, started over 3 and a half years ago (unspecified date) for neuropathy; lorazepam for pain and to sleep; ongoing acyclovir for herpes; ongoing omeprazole (PRILOSEC); ongoing fexofenadine hydrochloride (ALLEGRA); ongoing glucosamine; ongoing cyanocobalamin (VIT B12); ongoing daratumumab taken for cancer treatment; ongoing vitamins; MSN (Did not confirm what MSN was), stuff for bones and for her fibromyalgia. The patient previously received the first dose of (BNT162B2, Lot Number: EL9264) administered in left arm on 29Jan2021 09:30 as single dose for COVID-19 immunization. The patient had a reaction to the second vaccine. The patient experienced left arm hurting on 19Feb2021. She did not feel first one at all. The second one hurt. Arm still hurts when gets up in the morning and reaches for something. She can still feel it. Two (2) days after the second vaccine on 21Feb2021, neuropathy felt worse; her eyes were extremely sensitive to light. She sat inside with shutters closed. She was very sensitive to light. She went outside to walk, wore sunglasses and large brimmed hat. At times she had to stop. She couldn't open her eyes. She felt more on her left side. She had to pull the brim down. She was also getting muscle spasms in right arm and under right breast and going across her stomach and in legs at times. It was more in her arm and stomach areas. She was getting in in legs also. Her eyes are still a little sensitive but not bad. Her doctors wanted her to go off her neuropathy medication. They also talked about replacing the Gabapentin with other medications, but it was explained they all have side effects. She had been taking 2 pills and went down to 1 pill. Neuropathy got worse. They did not think the Gabapentin was part of it. Confirmed with caller that neuropathy medication was Gabapentin. They did not think pill had anything to do with it. Caller stated that she had been on it for at least 4 years. She had been afraid to start on something else. She said everything had something. Caller reported that she has been back on 2 pills of Gabapentin for 3 weeks now. On unspecified date, the end of her fingers and toes are still hurting and feel frozen. At her next appointment, she wanted to know if can go on 3 pills and then cut back. She had it for 4 years, but it got worse. This was under control, the neuropathy, and now all of this threw it out of control. Caller stated that everything calmed down about 9 days later. She had problem with her eyes, she did not have to sit inside in the dark. The neuropathy was there but not quite as painful. After going down to 1 pill of Gabapentin, it got worse. In the past she had dry eyes. She went to 3 different doctors and had different eye drops. They mentioned that her blink was not normal. They put plugs in and for about year, her eyes didn't bother her. At her first appointment, she checked her eyes. She ordered permanent plugs for her eyes for her dry eyes. She had slow abnormal blink on 21Feb2021. Very slow blink. It was causing eyes to be dry. They had suspicion that it was Benign Essential Blepharospasm on unspecified date. She wanted her to stop taking the Gabapentin as side effect is loss of muscle. On unspecified date, her eyes were red and irritated when she was in for her treatment. She was having hard time in there. Her next appointment was 19Mar2021. Caller said her first appointment was 09Mar2021 and she put in plugs. Her vision was blurry. PRIVACY felt she definitely had Benign Essential Blepharospasm. She talked to other doctors and it was agreed this is what she had. The only cure for Benign Essential Blepharospasm is these little Botox injections in her eye. Caller stated on 23Mar2021 she went back. Her eyes were getting worse. She had abnormal blinking problems opening and closing her eyes. She injected Botox on top. Her vision was clear and her blink was back to normal. This only lasted for half an hour. At the visit she saw white circle around the cornea. Caller stated the cure didn't work. Next visit was 30Mar2021. Her eyes were getting worse and worse, mainly only the whites of her eyes were showing. She was having trouble keeping her eyes open. Caller said that a few years ago she got up 3 times in the middle of the night and it took a minute or two to get her eyes open. Her fear was that she couldn't get her eyes open. Caller stated that it was exhausting to keep her eyes open. She got medicine drops to keep her eyes open. 06Apr2021 the white circle around her cornea was getting smaller. It was still blurry. It was burning, but it was a pinch better. She had more control over the muscle. The drops were Apraclonidine ophthalmic drops. At this point her eyes were barely open. Mostly saw whites of eyes. Barely color. Caller stated that she started 2 pills of Gabapentin. On 19Apr2021 white around cornea gone. She had blurry days but also clear ones. They ordered MRI (Magnetic resonance imaging). Her blink was still abnormally slow. When she tried to read or watch TV, it strained her eyes. 02May2021 MRI was done. She saw PRIVACY 03May2021 for treatment and he already had MRI results. MRI normal. They talked about Gabapentin and said he did not believe it was that. Caller says she told him that she had gone back on it. She was getting more muscle control. She continued to use ointment that they had given to her. She told her not to drive. She used the ointment twice daily. It was Erythromycin 5mg. She put in in her eyes twice daily. On 07May2021 appointment PRIVACY said vision was 20/30. It was 20/50 when it was bad. The white circle in her eyes was slightly back. Seeing improvement. On 21May2021 was last appointment. PRIVACY checked her vision and it was 20/25. Caller said she was dancing around. She looked so much better. Her blink was more normal. PRIVACY confirmed that all of the problems were from the second dose. Caller stated that her friend knew a scientist that said that if it was from vaccine, it would take at least 3 months to get normal. It is getting more normal, her eyes. She is driving. Once in awhile it gets a little blurry but mostly pretty clear. It is nothing like before. She could only read one line and texting she knew where it was. She mainly sat around with her eyes closed resting them. Her biggest fear was they would close and not open. Treatment for the events slow abnormal blink, Benign Essential Blepharospasm, her eyes were red and irritated, vision was blurry, white circle around the cornea included Eye plugs, Apraclonidine ophthalmic drops, Botox on eyes, Erythromycin Ointment. She had transplant 3 years ago, bone and blood for Multiple Myeloma. Her doctors researched the chemotherapy she had for the transplant to see if it had anything to do with this. Caller than gave more information regarding the transplant. She had pneumonia. She was supposed to have transplant. There was a shadow on her lung. She had CT scan on unspecified date. She had to cancel her transplant. Something was in the lung. They did a biopsy on her lung (unspecified date). During the biopsy, they pulled her arm down hard. That is when the neuropathy started. She had fungus from the pneumonia. It took 3 months to heal the fungus. Cancer was back up higher than the first time. When it was down low enough, she had the transplant. Caller stated that day or two after blood test for Myasthenia Gravis, she had difficulty swallowing. She looked at internet. She thinks it was just nerves and trying to keep her eyes open. It was exhausting. She called a girl to come stay with her and it went away. When she looked at the internet, she got shook up. The events neuropathy felt worse, extremely sensitive to light, slow abnormal blink, benign essential blepharospasm, her eyes were red and irritated, vision was blurry, white circle around the cornea, muscle spasms in right arm and under right breast and going across her stomach and in legs at times resulted in physician office visit. The patient underwent laboratory test which included Blood test for Myasthenia Gravis in 30Mar2021 with negative result, MRI eyes on 02May2021 with normal result. The outcome of the events neuropathy felt worse, slow abnormal blink, Benign Essential Blepharospasm was not recovered; the events left arm hurting, eyes were extremely sensitive to light was recovering; the outcome of white circle around the cornea recovered on 19Apr2021; and the outcome of the remaining events was unknown.
77 2021-06-10 nerve pain, tingling Pain on left side with tingling, Shingles, Antiviral Valtrex, Nerve pain Gabapentin, and Zyrtec for ... Read more
Pain on left side with tingling, Shingles, Antiviral Valtrex, Nerve pain Gabapentin, and Zyrtec for treatment.
77 2021-06-16 burning sensation, tingling Last night all of the sudden the skin on my left leg started to fell like a had a sunburn; it starte... Read more
Last night all of the sudden the skin on my left leg started to fell like a had a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; she did not get a good night of sleep; exhausted; too I was very aware of my stomach, now feel the tommy again and burning is getting less; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown) via unspecified route of administration on 25May2021 as single dose for COVID-19 immunization. Medical history included drug hypersensitivity. The concomitant medication was not reported. Patient reported that in May2021 after the first dose of the vaccine patient was exhausted for 5 full days, her arm never hurt but she was very aware of her stomach and for 5 days she had to seat still and that finally past. On 10Jun2021 all of the sudden the skin on her left leg started to feel like a had a sunburn, it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn, she tried to put the Aspercreme on it thinking that her take care of this terrible feeling but that did not help it made it worse so she washed it off. This all started off around 9:30 pm last night she finally got in bed around 10 pm. Patient was trying to sleep with her leg outside of the covers because it felt like it needed to be cooled down, she had AC on and fan. "she did not get a good night of sleep because she kept feeling her leg and did not know what else to do for it. "This morning she was very tired of course from last night, very aware of her stomach again which happen along of getting the first shot for those 5 days and she was exhausted and then too she was very aware of her stomach, now feel the tommy again and burning was getting less, but she had no clue was this was something anybody has reported. Patient was highly sensitive to medications. Patient never get any type of immunizations prior to this since she was a child. in a week she will be 78 years old, she was due for her second shot on 15Jun2021.The outcome of the event exhaustion was recovered, stomach burning sensation was recovering and sunburn, burning sensation, tingling sensation, feeling abnormal, sleep disorder was unknown. Information on Lot/Batch number has been requested.
77 2021-06-16 pain in extremity, burning sensation she had 5 days of exhaustion where she felt like she couldn't get out of her chair; she was also ver... Read more
she had 5 days of exhaustion where she felt like she couldn't get out of her chair; she was also very aware of her stomach; two twinges in her arm; she couldn't even stand clothes on her legs; skin on her left leg started to hurt so much that it reminded of her of having a neuralgia; She had stinging on the top and behind her knee and it traveled down towards her ankle and up towards her upper thigh/stinging in certain parts of her leg; skin on her left leg feels burning; left leg felt like it needed cold and not heat; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0178; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in left arm on 25May2021 at 14:30 (at the age of 77-year-old) at a single dose for covid-19 immunisation at Clinic. Medical history included ongoing high blood pressure, high cholesterol and it runs in her family (She has tried all the different "statin" medications and she couldn't tolerate any of them. Her cardiologist told her there was an injection she could take for her cholesterol every two weeks and it was supposed to be like a "liquid plumber" for your veins. She is so sensitive to medications including all these "statin" medications, there is no way she can take the bi-weekly injection. It might have a much more profound negative affect on her. She was so leery of taking medications, even over the counter medications), gastrooesophageal reflux disease (GERD), 4 cardiac stent placements in 2015, blood pressure abnormal, allergies (unspecified), sinus are swollen, neuralgia, cataract surgery (a year and half ago), retina had swelled and sensitivity to heat. Concomitant medications included acetylsalicylic acid (ASPIRINE) chewable tablets at a dose of 81 mg daily for sinuses are swollen (her sinuses are not swollen at this time), loteprednol etabonate (LOTREL) for blood pressure abnormal. The Lotrel keeps her blood pressure around 120/70mmHg, famotidine (PEPCID) for gastrooesophageal reflux disease. The patient previously took tylenol and experienced allergy and giant hives. Aspirin give her hives but usually a hive here or there, not real big hives, ilevro for retina swelling and affected her skin on her face (She did have a problem while she was taking the steroid eye drops. They made her feel very unwell. She does not take Prednisone for the same reason. She had tried many different steroid eye drops and so many of them gave her a problem. She ended up taking Ilevro. She had no choice but to take it. The Ilevro affected the skin on her face. Her retinas had to stop swelling. Everything is fine now. She has no glaucoma or macular degeneration. This occurred a year and half ago when she had her cataract surgery). She had given the nurse who gave her the injection a list of all her allergies and sensitivities and the nurse reviewed the list and didn't see anything in the Covid 19 vaccine that would cause the caller harm based on her list of allergies and sensitivities. The caller took a deep breath and prayed while she received the Covid 19 vaccine. After the vaccine she waited at the facility and she was fine and then she left to go home. She ever had an adverse event with any other vaccines she reports she has not been vaccinated with anything since she was a child. She didn't even have the Polio vaccine. The patient did not receive any other vaccinations within four weeks prior to the first administration of the suspect vaccine. After getting the Covid 19 vaccine, on an unspecified date, the patient had 5 days of exhaustion where she felt like she couldn't get out of her chair and she was also very aware of her stomach. Her stomach wasn't upset but she was aware of it. That slowly passed and she started doing the things she needed to do. She needs to walk because of her heart stents. She had been fine after the Covid 19 vaccine until last night on 10Jun2021 at 21:30 the patient skin on her left leg started to hurt so much that it reminded of her of having a neuralgia. She provides an example of her sometimes feeling a draft and she can develop a neuralgia from the draft for a day or two. That's what her leg felt like initially. As the night wore on, around 22:00, she realized she couldn't even stand clothes on her legs. She wears nightgowns, not pajamas and she had to take her nightgown off her leg. The sensation in her leg started changing, she could feel that she not only had the skin hurting sensation but now she had stinging in certain parts of her leg. She had stinging on the top and behind her knee and it traveled down towards her ankle and up towards her upper thigh. It was bizarre. She thought about it this morning, 11Jun2021, what it felt like. She remembered way back, long ago, and she was not a sun person, but it felt like how a sunburn would feel. The skin on her left leg feels burning. She used Aspercreme on her leg thinking it will help with the pain. She wiped all the Aspercreme off her leg. She could not cover her left leg. Her left leg felt like it needed cold and not heat. She does have a history of sensitivity to heat. She runs her air conditioner, and she had a ceiling fan above her bed. She had her left leg exposed and out of her bed covers to try and get the cold air on her hot leg. Finally, around 23:30, her leg still bothered her, but she was able to go to sleep. She twisted and turned at night but was finally able to put her bed cover back on her leg but lightly. The sensation was still there in her leg. She was so sensitive. On an unspecified date, the patient had two twinges in her arm and then her arm never hurt again. The events did not result in emergency room or Physician Office. She is due for her second Covid 19 vaccine on 15Jun2021. The outcome of the events she had 5 days of exhaustion where she felt like she couldn't get out of her chair, she was also very aware of her stomach, two twinges in her arm was unknown and the rest of the events was not recovered. Information on lot/batch number was available. Additional information has been requested.
77 2021-06-16 pain in extremity I'm experiencing muscle and joint pain on the right side arm and hands. On the left side inside musc... Read more
I'm experiencing muscle and joint pain on the right side arm and hands. On the left side inside muscle of the arm. Pain in right leg that is severe knee joint and the muscle behind the knee. Left leg pain in joint and muscle. Prescribed Ibuprofen 600mg that is not helping.
77 2021-06-17 slurring, tremor, seizure Started with left hand being useless, then shaking. Shaking moved up to elbow. She tried to take o... Read more
Started with left hand being useless, then shaking. Shaking moved up to elbow. She tried to take off her sweatshirt and her arm froze--this is the last thing she remembers. Husband called 911 and she went to the ER. She had had a seizure and they found 2 brain lesions. She had a CT scan and an MRI in the ER. There was memory loss in the beginning and slurring of words. She felt a weighty fatigue. Was put on Keppra for seizures. Had consults with neurology, a neurosurgeon, a neuro-oncologist--all unsure of what exactly these brain lesions were. Back left lower part of brain: a small lesion, which was basically ignored Right side, towards front, part of brain, on top of and/or intertwined with motor strip: not sure what this is, a stroke or tumor (the neurosurgeon and neurologist had differing opinions) 2/22--1st MRI--shows 2 spots between these 2 MRIs the bloodwork, CT scan, and ultrasound are done--results normal 3/23--2nd MRI--larger lesion is bigger. Was not thought to be a cancerous tumor 4/23--3rd MRI--Looks like larger lesion is improving. A scheduled brain biopsy is postponed 5/20--4th MRI--the small spot is almost gone and the larger spot is much smaller, about 1/8th the size of the February MRI. According to the neuro-oncologist, this was an atypical stroke.
77 2021-06-17 pain in extremity getting a rash on her back; sore arm; She mentioned that she had a sore arm after the first shot; Sh... Read more
getting a rash on her back; sore arm; She mentioned that she had a sore arm after the first shot; She was told by a nurse that she could take claritin, dimetapp, or tylenol before receiving her second dose, to help lessen the potential for side effects.; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265; Expiration Date: 31May2021)via an unspecified route of administration, administered in Left Arm on 28Jan2021 at 08:30 as First Dose, Single Dose COVID-19 immunization. The patient's medical history included shingles seven years ago, blood pressure abnormal, rheumatoid arthritis, hysterectomy at a young age and was put on Premarin. She was on a higher dose initially but is currently taking 0.3mg daily. When they have tried to take her off of Premarin she has a reaction. She is unsure if it is a reaction or mental. Product is filled in a pharmacy bottle. NDC, Lot and Expiry are not on the label. She has had shingles twice. Clarifies that her last episode was 10 years ago. She is due a Shingrix vaccine. Her physician says with her rheumatoid arthritis, taking Hydroxychloroquine and Covid he doesn't recommend that she get the Shingrix vaccine. No Patient's Medical History including any illness at time of vaccination. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN)Hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for blood pressure abnormal from 2011 and ongoing; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for rheumatoid arthritis from Dec2019 and ongoing; estrogens conjugated (PREMARIN) taken for hysterectomy. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Prior Vaccinations within 4 weeks No Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient mentioned that she had a sore arm after the first shot from 28Jan2021 to 01Feb2021 and she was told by a nurse that she could take claritin, dimetapp, or tylenol before receiving her second dose, to help lessen the potential for side effects, she was getting a rash on her back from 04Feb2021 and ongoing. This started as a little circle under her shoulder blade. Is this a reaction to the vaccine or could it be shingles. No relevant tests were performed. The patient did not visit any Emergency or Physician office for the AEs. The outcome for the events was sore arm was recovered/resolved and the Rash was not recovered/not resolved and Unknown for rest of the events. Follow-up attempts are completed. No further information is expected.
77 2021-06-20 numbness 6 days from vaccine patient has no feeling in her right leg, visit pcp, vascular scan for bloodclots
77 2021-06-24 weakness Little bit weak today; sore muscle; body ache; had chills too; I would feel bad.; if I smell food, i... Read more
Little bit weak today; sore muscle; body ache; had chills too; I would feel bad.; if I smell food, it would you know kind of sickening but I ate,; I had unwell feeling, like you getting the flu; This is a spontaneous report received from a contactable consumer (patient). A 77-years-old (reported currently 77 and half, 78 in august so) female patient received first dose of bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 22Jan2021 (age at vaccination: 77 years) as single dose for covid-19 immunisation. Medical history was not reported. The patient's height is about 5 (feet) 3 (inches) and right now her weight this morning was 116.7 (pounds), closer to 117 (pounds) (not captured in tab). Concomitant medications included vitamins once a day (multiple vitamins), calcium plus D (calcium, colecalciferol) per day, ciclosporin (RESTASIS) for dry eyes (in eye twice a day). On 22Jan2021, the patient had first shot and started having a sore muscle and the body ache and everything; on the same night she had little bit chills too, but side effects were mostly at night and then about (incomplete sentence). And then during the day she was fine, and it was just during the evening when she would feel bad. And then about Thursday (dates unspecified) when she woke up and she had unwell feeling, like getting the flu. And then at times like if she smells food, kind of sickening, but ate, had a good appetite. Sometimes she would get up and would feel better. The symptoms had gradually gotten better and went to a grocery shopping in-between the time, but it was sick, but now she would not be sick again and she was almost back to normal today. She was wondering is this normal to have this kind of symptoms for 2 weeks. When questioned about stop date of events, she reported that she was not feeling really bad right now, she just feels, just a little bit weak today (05Feb2021), feel like everything's going away. When questioned about outcome of event: consumer stated, she thinks she was recovering. The patient did not take any treatment. She did call her doctor and didn't seem to be concerned. She didn't take any Tylenol or anything else. She did not have the seizure; she did not have injection site swelling or redness or so. She reported alright and was going to have her next one. The outcome of event asthenia was unknown and for other events it was resolving. Information on lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.
77 2021-06-24 pain in extremity First dose: maybe a sore arm a little bit; a sinus issue and it led to mucus; This is a spontaneous ... Read more
First dose: maybe a sore arm a little bit; a sinus issue and it led to mucus; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 4. A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in Arm Left on 23Mar2021 20:10 (76-years-old at the time of vaccination), as a SINGLE DOSE for covid-19 immunization. Patient vaccination because high risk of getting Covid, cannot wear mask due to breathing and lung issues. The patient's medical history included Breathing issues, Inoperable lung cancer, Diagnosed Nov2010. She took 2 different chemos for 3.5 years and had 6 weeks of strong radiation so that's whys she is at a risk of getting Covid, Lung issues (respiratory illness), Allergies like in spring and summer, compromised immune status, genetic / chromosomal abnormality, endocrine abnormalities (including diabetes), and obesity. The patient's concomitant medication included Xyzal every night for the allergies which does not always work and Amoxicillin 500mg 3 times daily for sinus issue. The patient previously took flu shot. On an unspecified date, the patient experienced first dose: maybe a sore arm a little bit and a sinus issue and it led to mucus. On An unspecified date Mar2021, the patient underwent lab tests and procedures which included blood test: unknown. On 12Apr2021, the patient was taking Amoxicillin, as Therapeutic measures as a result of a sinus issue and it led to mucus. The outcome of the events first dose: maybe a sore arm a little bit was recovered on an unspecified date and a sinus issue and it led to mucus was not recovered. No follow-up attempts are needed. No further information is expected
77 2021-06-24 pain in extremity right arm is unbearably painful after injection/My arm is hurting so bad; didn't sleep all night bec... Read more
right arm is unbearably painful after injection/My arm is hurting so bad; didn't sleep all night because of the pain/I really can't sleep enough, I mean it's hurting; This is a spontaneous report from a contactable consumer. This 77-year-old female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809, Expiry date not reported) via unspecified route of administration in right arm on 03Feb2021 (at age of 77-years old) as single dose for Covid-19 Immunization. Patient medical history includes high blood pressure. Patient concomitant medications include Amlodipine (once a day) used for blood pressure from unknown date and ongoing, Hydrochlorothiazide, lisinopril (once a day) used for high blood pressure from unknown date and ongoing. Patient previously received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number:EK9231, Expiry date not reported) via unspecified route of administration on 15Jan2021 as single dose for COVID-19 Immunization. On 03Feb2021, patient had shot at noon, she got the injection in her right arm, she developed the arm pain last night about 8 or 9 pm. She said it will feel better one minute, and then she will have a sharp pain going through her arm again. Patient experienced like her arm is hurting so bad; patient stated that I really cannot sleep all night because of the pain/I really cant sleep enough, I mean it is hurting. Patient right arm is unbearably painful after injection and stated that she did not let nothing get around the injection area and she rubbed her arm with alcohol.Caller verifies she talked with a man yesterday and reported this information and gave information on what was on her vaccine record card. Caller verifies she was not provided with any type of reference number.Upon follow up reporter stated that the reason she got it because she works at the hospital, what mandated, and she got it. Patient stated that, I am having a problem so I could get the paid today, okay but look can I rub my arm with some alcohol. Consumer was informed about Pfizer Medical information department.Treatment received for event by taking Tylenol. Patient underwent lab test and procedures include blood pressure measurement is high on unspecified date. The outcome of events was not recovered. Follow-up (04Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (mom) that: new information include vaccination at right arm and updated age 77years on onset of reaction, concomitant medications,Treatment received for event. Follow-up attempts are completed. No further information is expected.
77 2021-06-24 pain in extremity hard time walking; tiredness; foot swollen; foot hot to touch; Since receiving the vaccine she has b... Read more
hard time walking; tiredness; foot swollen; foot hot to touch; Since receiving the vaccine she has been sleeping a lot for about 3 days; Foot pain; foot redness; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL9261)via an unspecified route of administration, administered in Left Arm on 02Feb2021 at 12:00 (at the age of 77-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included parkinson's disease, transient ischaemic attack, hypersensitivity, sinus disorder, Cardiac disorder, vaginal infection, pain, incontinence, antidepressant therapy, hallucination, unspecified vitamin D deficiency. No relevant tests done. The concomitant medications included ongoing estradiol (ESTRACE VAGINAL) taken for vaginal infection from 2019, ongoing colecalciferol (VITAMIN D 3) taken for vitamin d deficiency, ongoing pimavanserin tartrate (NUPLAZID) taken for hallucination from 05Feb2021,ongoing venlafaxine (VENLAFAXINE) taken for antidepressant therapy, ongoing carbidopa, levodopa (RYTARY) taken for parkinson's disease, ongoing mirabegron (MYRBETRIQ) taken for incontinence, ongoing atorvastatin calcium (ATORVASTATIN CALCIUM) taken for cardiac disorder, ongoing aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for transient ischaemic attack ,ongoing clopidogrel bisulfate (CLOPIDOGREL BISULFATE) taken for transient ischaemic attack, ongoing paracetamol (ACETAMINOPHEN) taken for pain, ongoing loratadine (LORATADINE) taken for hypersensitivity, sinus disorder, ongoing ascorbic acid, biotin, calcium, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, potassium iodide, pyridoxine hydrochloride, retinol acetate, zinc sulfate (CENTRUM MULTIGUMMIES WOMEN), amantadine hydrochloride (AMANTADINE HYDROCHLORIDE) taken for parkinson's disease. Since receiving the vaccine she had been sleeping a lot for about 3 days (on 03Feb2021). Caller stated she knew that was supposed to be a side effect. Adds her mother was a Parkinson's patient and usually able to walk using a walker. She was having a hard time walking (03Feb2021) and had to use the wheelchair. Clarifies her mother started sleeping quite a bit about three days after the vaccine on Friday 03Feb2021. Mentions previous to this on Wednesday after the vaccine, her mother was complaining of foot pain (on 03Feb2021) towards the side midway on the foot in the arch and on the top where you tie your shoe. It was almost like she dropped something on it but she did not. It was slightly swollen on the top and red and warm (on 03Feb2021). Friday when her mother started sleeping so much, they had resort to the wheelchair. She took her to see the nurse practitioner on Friday for the foot, who sent her to the ER for an X-ray on Saturday so they went out again on Saturday to get the foot x-ray done. The foot was not broken. They did treat her mother's foot with Cephalexin. Her foot was fully recovered now. Her mother's tiredness (on 05Feb2021) was persisting and she was having a hard time just getting up from the bed and to go across the room even though the foot was fine. Today they have a message into her neurologist. Adds today was the first day her mother started talking about needing or wanting to go to the hospital for her tiredness and not being able to walk (06Feb2021) Her mother was scheduled for the next dose 23Feb2021.The patient underwent lab tests and procedures which included x-ray limb: the foot was not broken on. Therapeutic measures were taken as a result of foot pain, foot redness, foot swollen, foot hot to touch.The outcome for the events foot pain, foot redness, foot swollen, foot hot to touch was recovered/resolved on 08Feb2021 and not recovered/not resolved for rest of the events. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected
77 2021-06-24 tingling, numbness, tremor Systemic: Chills-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Syste... Read more
Systemic: Chills-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient had faint feeling, chills, temperature normal, blood pressure 164/90 pulse 60. Chief complaint was unusual taste and numbness of lips. Symptoms improved over 30-45 min period
77 2021-06-27 weakness 02/04/ 2021 the day of the vaccination, within the hour, so dizzy and weak I couldn't sit in the cha... Read more
02/04/ 2021 the day of the vaccination, within the hour, so dizzy and weak I couldn't sit in the chair. I felt I had to lie down. I couldn't keep myself upright. The doctor thought it was inner ear disturbance and sent me to an ENT. ENT did not find anything abnormal. I had to get my potassium on the 3rd of March. I saw the ENT on the 4th of March. The vertigo persisted for a while, and every now and then I feel weakness and I need to sit down.
77 2021-06-27 pain in extremity Dizziness, my arm hurt. Saw the ENT on Thursday, 03/04/2021, for my dizziness. The doctor said there... Read more
Dizziness, my arm hurt. Saw the ENT on Thursday, 03/04/2021, for my dizziness. The doctor said there was nothing wrong with my inner ear. I have had a persistent headache, subtle headache after the vaccine.
77 2021-06-29 difficulty speaking Difficulty breathing/she could barely breathe; felt like her "left lung is made of stone"/felt like ... Read more
Difficulty breathing/she could barely breathe; felt like her "left lung is made of stone"/felt like her left lung felt like it was going to her back; had pain in shoulder blade; felt like she is not getting enough oxygen/she was not getting enough oxygens to her brain; slept for 12 hours; she was angry and upset; she was angry and upset; her voice has changed; she has some wheezing but it is coming from in between her soft and hard palate; States after the vaccine was tired and lethargic; States after the vaccine was tired and lethargic; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot number: EL9264, Expiration Date: 31May2021), via intramuscular, administered in Arm Left on 09Feb2021 (Age at vaccination 77 Years) as 1st dose, 0.3 ml single for covid-19 immunisation. The patient had past drug event to a reaction to the inhaler that was prescribed to her, had excruciating pain in feet, hands and knees never happened in her life. Inhaler was Albuterol sulfate, HFA, inhalation areol, 90mg per actuation, 18gm, inhale 2 puffs into lungs every 4 hours as needed for SOB, she did have Covid in Nov2020 prior to the vaccine, concomitant medications were not reported. The patient experienced she had been calling since the 16-17Feb2021, a week after she had the first vaccine shot on 09Feb2021 states about 2 hours after the first Pfizer Covid vaccine, she had difficulty breathing thought maybe it was a side effect from she had Physical Therapy earlier that day, but stated as the week went on the difficulty breathing, even walking down stairs, become more difficult, states the following Tuesday, she went to Physical therapy and everything went okay and when she came home and walked two houses down the road to her neighbours house to drop something off. she could barely breathe on 09Feb2021, felt like her "left lung is made of stone"/felt like her left lung felt like it was going to her back, had pain in shoulder blade, felt like she was not getting enough oxygen/she was not getting enough oxygens to her brain, slept for 12 hours and went to urgent care, (unspecified date in 2021) she was angry and upset she has some wheezing but it was coming from in between her soft and hard palate, her voice has changed sounds gravel-y, stated after the vaccine was tired and lethargic. She laid her head down on the table and went to sleep for 2 hours at the kitchen table, does not believe she had brain damage. She wanted to know she did not have good experience with first dose. Her second dose was due today and stated she will be late for her second dose, also wanted to know "YES or NO" about taking the second dose. States the urgent care doctor told her they have a theory that she already had antibodies in her body and then the influx of antibodies from the vaccine caused the reaction. The patient underwent lab tests and procedures which included sars-cov-2 test and she did have covid-19 on Nov2020 states she did have Covid in Nov2020. Patient received treatment of Stated she went to urgent care and they gave her a breathing treatment. The outcome of events was difficulty breathing/she could barely breathe was recovering, rest of the all events outcome was unknown. No follow up attempts are possible. No further information is expected.
77 2021-07-05 weakness very weak/wrung out in morning. Happened two more mornings over next two weeks. My heart normally ... Read more
very weak/wrung out in morning. Happened two more mornings over next two weeks. My heart normally beats irregularly due to mitral valve prolapse. But for about 3 weeks lying down particularly on my right side it was practically continual. Also my back started hurting. Also there was family stress. Also I was concerned when they weighed me at the doctor's office that I had lost 3 pounds. My weight had previously gone down from 130's to 129. But it went down to 126 at the office. Doctor did thyroid and liver blood tests. All was normal and stable. I have gotten the weight up to almost 128 since then.
77 2021-07-06 weakness Pfizer COVID Vaccine EUA Pfizer Dose 1 2/6/21 (lot # not listed) Pfizer Dose 2 3/6/21 (lot # not li... Read more
Pfizer COVID Vaccine EUA Pfizer Dose 1 2/6/21 (lot # not listed) Pfizer Dose 2 3/6/21 (lot # not listed) COVID Positive 5/25/21 at PCP office (but negative upon repeat testing 5/25/21) 5/25/21: The patient is a 78-year-old female presents emergency department today after testing positive for COVID-19 at her PCP office, they recommended she present to ED to rule out pulmonary embolism. Patient has a past medical history significant for ESRD on HD Monday Wednesday Friday, hypertension, diabetes mellitus type 2, anemia of CKD, and osteoarthritis. Of note, the patient had her COVID-19 Pfizer vaccination series completed in February of this year. On arrival to the ED, the patient's temperature is 98.4° F, heart rate 68, respiratory rate 26, saturating 90% on room air with blood pressure 163/63. The patient did desaturate to 87% on room air when ambulating in the room. The patient's laboratory studies were significant for HGB 11.3, ESR 44, CRP 1.7, BUN 17, CR 4.80, UA: Proteinuria, trace hematuria, small leukoesterase, many bacteria, 11-30 pyuria, 1-3 RBCs and moderate squamous epithelial cells sent for culture. Blood cultures x2 obtained. Chest x-ray shows no acute cardiopulmonary findings. V/Q scan showed normal exam. EKG showed normal sinus rhythm. The patient was seen emergency department laying in bed. She reports worsening shortness of breath over the weekend and COVID like symptoms for the past week. She reports some dyspnea on exertion. She states she has been weak, fatigued, had some chills, and was seen by her PCP, who tested her for COVID-19 and she tested positive. This COVID-19 test is not and are records. The patient has had some desaturations less than 90% when she falls asleep. She wishes to be a full code. 6/1/21: She is admitted to the hospital, as mentioned above 0 repeat COVID test is negative. V/Q scan is reported as normal. She is started on dexamethasone 6 mg IV daily, along with IV antibiotics ceftriaxone Zithromax and Acapella. Pulse ox is monitored, oxygen is weaned off patient has been stable on room air and has been afebrile. Nephrology consult is requested, patient had hemodialysis as per Nephrology recommendations on Monday, Wednesday and Friday. Her blood pressures were uncontrolled, her home medications Coreg dose was increased to 37.5 mg p.o. b.i.d. and Procardia XL increased to 60 mg p.o. daily and blood pressures have been stable now. Patient did complain of weakness to ambulate, had physical therapy and occupational therapy evaluation. She is being discharged home today in stable condition for skilled nursing. She is off steroids now. Discharge plan is discussed with the patient.
77 2021-07-06 speech disorder Did not receive 2nd dose of vaccine, lisp tongue, couldn't pronounce any words, dizzy, itchy rash/hi... Read more
Did not receive 2nd dose of vaccine, lisp tongue, couldn't pronounce any words, dizzy, itchy rash/hives on torso, very wobbly could not stand, prescribed an EpiPen.
77 2021-07-12 weakness Patient presented to the ED and was subsequently hospitalized on 3/11/2021 for acute cystitis with h... Read more
Patient presented to the ED and was subsequently hospitalized on 3/11/2021 for acute cystitis with hematuria and acute kidney injury. Patient presented to the ED and was subsequently hospitalized on 4/19/2021 with generalized weakness and confusion. These visits are within 6 weeks of receiving COVID vaccination.
77 2021-07-12 slurring My mother has had her share of health problems predominantly relating to her Afib diagnosis,however ... Read more
My mother has had her share of health problems predominantly relating to her Afib diagnosis,however after every dose she experienced side effects that have set her back in ways that were completely new,loss of memory Sluring her words, really bad head aches leading up to the first and second stroke.She was able to drive live on her own had sweet and kind,funny personality now that is all gone. She is a shell of who she was and our family just simply misses her,I truly just wish that we would have had been warned of the possible risks to patients like her prior to getting the vaccine.No matter how small the possibility of adverse reaction.We would have chosen to keep her longer.
77 2021-07-13 muscle spasms Cramping; Diarrhea; This is a spontaneous report from a contactable nurse (the patient). A 77-year-o... Read more
Cramping; Diarrhea; This is a spontaneous report from a contactable nurse (the patient). A 77-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249) via an unspecified route on left arm on 11Feb2021 at 14:00 (at age of 77-year-old at vaccination) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had medical history of hypertensive. Concomitant medications included hydrochlorothiazide, triamterene (DYAZIDE); biotin; glucosamine; metoprolol succinate (TOPROL XL); fish oil for unknown indications within 2 weeks prior to the COVID vaccine. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient previously took scopolamine [hyoscine butylbromide] and demerol and experienced drug allergy. On 18Feb2021 at 12:15 PM, the patient experienced cramping and diarrhea starting a week after first shot and lasting 2 weeks after second shot. Doctor or other healthcare professional office/clinic visit for the events. The events were treated with Imodium and Bentyl. The outcome of the events of cramping and diarrhea was recovered on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
77 2021-07-15 weakness, muscle spasms Apr 28th began noticing right upper abdominal pain, from the sternum area, down and around base of ... Read more
Apr 28th began noticing right upper abdominal pain, from the sternum area, down and around base of right lower rib cage and toward my back. A tightness feeling going also toward my back. Interfering with breathing because pain increase with deeper breath but did not feel short of breath. Area became tender to touch. Felt like muscle spasms in "bread basket" area. These cont'd off and on - affecting size of meals I would eat - too much increase the discomfort. Self exploring lead me too exercising and deep breathing to advice via website. Provided some relief and improved breathing ability. By May 2th things became more severe- 3 morning episodes of severe gripping pain, sweats, chills ,nausea, vomiting, weakness - Husband took me to Emerg May 4th. Bld in urine. Kidney scan - no stones; Bld work - normal. Agan in Emerg June 29th. No medical reason given for the severe pain. Sent home.
77 2021-07-15 pain in extremity RIGHT ARM HURT THE NEXT MORNING. LEFT ARM HURT THE 2nd MORNING. A WEEK LATER MY BLOOD PRESSURE WEN... Read more
RIGHT ARM HURT THE NEXT MORNING. LEFT ARM HURT THE 2nd MORNING. A WEEK LATER MY BLOOD PRESSURE WENT UP ABOUT 40 POINTS AND I WENT TO DR AND HE RAISED MY BLOOD PRESSURE DOSE. THEN BOTH MY KNEE JOINTS SWELLED FOR A WEEK. THE SWELLING LEFT MY KNEES AND WENT DOWN TO MY ANKLE BONES. IT HAS BEENOVER A MONTH AND I CAN BARELY WALK.
77 2021-07-17 pain in extremity A little sore arm; She then developed pneumonia and a urinary infection; She then developed pneumoni... Read more
A little sore arm; She then developed pneumonia and a urinary infection; She then developed pneumonia and a urinary infection; This is a spontaneous report from a contactable consumer or other non-health care professional. A 77-year-old female patient received bNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration in arm on 03Jun2021 (at age of 77-year-old) as dose 1, single for COVID-19 Immunization. Patient medical history includes Memory Loss, Breast Cancer, Allergic to Sulfa Medication, Flexeril, Allergic to Clams and Shellfish, Pneumonia, Urinary infection. Patient concomitant medications were not reported. Caller reporting on behalf of his wife who received her first Covid 19 vaccine on 03Jun2021 and she developed pneumonia and a urinary infection. She was prescribed amoxicillin for her infection. The caller wanted to know how the antibiotic will affect his wife. He reports her second Covid 19 vaccine is past due by 2 weeks. He reports his wife gets pneumonia every year and it is not from the Covid 19 vaccine. She received her first Covid 19 vaccine on 03Jun2021 and was due for the second Covid 19 vaccine on 24Jun2021. This is discrepant from the above information that his wife is past due by 2 weeks but is documented as provided by the caller. She will not be able to get the second Covid 19 vaccine until the first week in Jul2021. She waited because she was prescribed a Z-pack for her pneumonia started on 29Jun2021.She developed a urinary infection, she has a history of getting urinary infections too. The doctor also wanted a chest x-ray to make sure that her pneumonia was gone. The Amoxicillin will double check that his wife has no more pneumonia and will clear up her urinary infection. She was hospitalized in 2019 because of a urinary infection. The doctor prescribed Amoxicillin and she cannot wait any longer to get her second Covid 19 vaccine. She must get her second Covid 19 vaccine before time runs out. He reports none of this has to do with the Covid 19 vaccine. These are problems that his wife has had before.Upon follow up when probing for information regarding the sore arm he and his wife experienced he reports the sore arm was minor, it was just where the injection was in jun2021. His wife had breast cancer and can only get injections in one of her arms. It was a little soreness, nothing, barely noticeable. He and his wife did exactly what the pharmacist said, they took a lot of fluids, drank Gatorade for electrolytes. He reports his wife is sleeping right now because she was at the doctor's office this morning. He reports his wife's doctor is being thorough before his wife gets the second Covid 19 vaccine. He is supposed to call the pharmacy to schedule his wife's second Covid 19 vaccine on 03Jul2021. The pharmacist told him not to cancel his wife original appointment because it would remove her from the system. He's will call on 03Jul2021 and hopefully his wife will be able to get her second dose on 05Jul2021 or 06Jul2021. At that time, she'll almost be off the Amoxicillin. He is asking what the effectiveness rate is of receiving the Covid 19 vaccine while on an antibiotic.The pharmacist told him the effectiveness is diminished for people who have taken an antibiotic. He believes the first Covid 19 vaccine provides 70% effectiveness while the second Covid 19 vaccine provides 95% effectiveness. His sister-in-law has titanium plates in her back and must take an antibiotic for the rest of her life and she received the Covid 19 vaccine. Advised in response to caller to discuss with Health care professional about the final decision about receiving the second dose to discuss the risks and benefits of the administration of the vaccine and the HCP is most familiar with the health history of his wife. Pfizer is unable to make treatment recommendations for individual patients. Patient underwent lab test and procedures include Chest X-ray result was it showed nothing, no pneumonia; SARS-CoV-2 test was negative; Urine analysis result was unknown; all tests done on Jun2021. The outcome of event was unknown. Follow up (29Jun2021): This is a follow up spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for a 77-year-old female patient (reporter's wife) that: New information include medical history, schedule of second dose, Lab test, event little sore arm, visit of physician office. No further information is provided or obtained.Information on lot/batch number has been requested.
77 2021-07-17 pain in extremity RBC, Hemoglobin, and Hct continue to elevate; RBC, Hemoglobin, and Hct continue to elevate; RBC, Hem... Read more
RBC, Hemoglobin, and Hct continue to elevate; RBC, Hemoglobin, and Hct continue to elevate; RBC, Hemoglobin, and Hct continue to elevate; CBC w/manual differential shows RDW - CV 22.9 % and RDW - SD 75.6 FL; 3 days after 2nd dose pain both legs from knee to bottom of both feet. Continuing still, today is day 6.; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6208), dose 2 via an unspecified route of administration, administered in arm left on 20Mar2021 at 08:30 (at the age of 77-years-old) as dose 2, single; and patient previously took BNT162B2 (Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in right arm on 25Feb2021 at 16:30 as dose 1, single for COVID-19 immunisation at other. Medical history included chronic obstructive pulmonary disease (COPD), Edema, Sleep Apnea, Irregular Heartbeat. And patient was allergic to ibuprofen and contrast dye. Concomitant medications included alendronate (FOSAMAX) 70 MG Oral Tablet Take 70 mg by mouth every 7 days. atorvastatin (LIPITOR) 20 MG Oral Table Take 1 tablet (20 mg total) by mouth at bedtime. calcium carbonate (TUMS) 500 MG Oral Chewable Tablet Chew 1 tablet three times daily. diltiazem (CARDIZEM) 60 MG Oral Tablet Take 1 tablet (60 mg total) by mouth twice daily. Fluticasone-Umeclidin-Vilant (TRELEGY ELLIPTA) 100-62.5-25 MCG/INH Inhalation Aerosol Powder, BREATH ACTIVATED Inhale 1 puff by mouth daily. furosemide (LASIX) 80 MG Oral Tablet Take 1 tablet (80 mg total) by mouth twice daily (8am/4pm) and Omeprazole 20 MG Oral Tablet Delayed Release Dispersible Take 20 mg by mouth daily. Prior to the vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within four weeks. On 23Mar2021, after second dose, the patient experienced pain in legs and feet. Treated for symptoms and bloodwork shows abnormal red blood cells. Labs repeated CBC with automated differential, CBC with manual differential shows RDW - CV 22.9 percentage and RDW - SD 75.6 FL. RBC, Hemoglobin, and Hct (Haematocrit) continue to elevate. The patient has been referred to hematology. The reporter stated the events result in Doctor or other healthcare professional office/clinic visit. On an unspecified date in Mar2021, the patient underwent lab tests and procedures which included blood test: abnormal red blood cells, computerised tomogram: unknown results, full blood count: RDW - CV 22.9 % and RDW -SD 75.6 FL (w/manual differential), haematocrit: elevated, haemoglobin: elevated, magnetic resonance imaging: unknown results (lower extremity), neurological examination: unknown results, red blood cell count: Elevated and ultrasound scan: unknown results. Therapeutic measures were taken as a result of events include medication for leg pain (bloodwork, ultrasound, CT, neurological nerve study, MRI and lower extremity). Since the vaccination, the patient had not been tested for COVID-19. It was reported there was no prolonged hospitalization. The outcome of the events was not resolved.
77 2021-07-20 speech disorder A few days after her second COVID vaccination, she developed severe tinnitus, cognitive impairment, ... Read more
A few days after her second COVID vaccination, she developed severe tinnitus, cognitive impairment, difficulty with speech and language
77 2021-07-27 weakness Was exposed to a positive COVID person. On 4/4 PT reported to the emergency department with cough, s... Read more
Was exposed to a positive COVID person. On 4/4 PT reported to the emergency department with cough, sore throat, fatigue, sinus congestion. Tested positive for COVID on 4/4. Chest x-ray done, diagnosed with pneumonia on oral azithromycin. On 4/7 PT returned to the Emergency department via ambulance - she was hypoxic, weaker and more short of breath - O2 sats in the 70s. Received blood on 4/5 as well as monoclonal antibodies. Troponin elevated at 0.409, EKG showed inverted T-waves.. Patient transfered to Hospital.
77 2021-07-27 weakness Was exposed to a positive COVID person. On 4/4 pt. reported to the emergency department with cough, ... Read more
Was exposed to a positive COVID person. On 4/4 pt. reported to the emergency department with cough, sore throat, fatigue, sinus congestion. Tested positive for COVID on 4/4. Chest x-ray done, diagnosed with pneumonia on oral azithromycin. On 4/7 pt. returned to the Emergency department via ambulance - she was hypoxic, weaker and more short of breath - O2 sats in the 70s. Received blood on 4/5 as well as monoclonal antibodies. Troponin elevated at 0.409, EKG showed inverted T-waves.. Patient transfered to hospital.
77 2021-07-27 pain in extremity she couldn't breathe very good and her heart started racing; she couldn't breathe very good and her ... Read more
she couldn't breathe very good and her heart started racing; she couldn't breathe very good and her heart started racing; Just didn't feel good; Tired; Felt queasy; Dizziness; blood sugar was low; Sore Left Arm; This is the spontaneous report from a contactable consumer. This 77-year-old female consumer reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6201 and expiry date: 31-May-2021) via an unspecified route of administration on 24-Feb-2021 at 08:15 in left arm (77-year-old), as dose 2, single for COVID-19 immunization. Medical history included of the patient included a dental surgery. When she got up in the morning her face was real puffy and she thought she looked like the Pillsbury dough boy. Both cheeks were swollen. This surgery was to remove a tooth. She stated that she took her premedication before her oral surgeon appointment. She previously had a kidney replacement and a shoulder replacement. She always takes pain meds before she does any dental work. She had blood pressure measurement, depression, knee arthroplasty, shoulder arthroplasty, thyroid atrophy, renal failure, coronary arterial stent insertion, hypothyroidism and steroid therapy. Concomitant medications of the patient included sertraline taken for antidepressant therapy, levothyroxine taken for hypothyroidism, potassium citrate taken for renal failure, atorvastatin taken for coronary arterial stent insertion, hydrochlorothiazide taken for blood pressure measurement, prednisone taken for steroid therapy from 27Jan2021 to an unspecified stop date; amoxicillin taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9265 and expiry date 31May2021) via an unspecified route of administration on 02Feb2021 in left arm (77-year-old), as dose 1, single for COVID-19 immunization and had no problems. It was mentioned that additional vaccines administered on same date of the pfizer suspect were reported as none. On 25Feb2021 the patient experienced sore left arm. On 28Feb2021 the patient did not feel good, tiredness, felt queasy, dizziness and blood sugar was low. So she had some orange juice and went about her day to grocery shop, so she laid down to take a nap and then felt okay. On 01Mar2021 she could not breathe very good and her heart started racing. Caller reported that she did not get clammy and that was why she did not feel it was hypoglycemia. She has not had that for years as she watched and made sure she does not eat too many carbs. She was tired and took a 3 hours nap. Caller states the whole time she just did not feel herself, but she just went on and pushed things aside as she had a life to live. She did not relate it to the vaccine at first. She got out her information paper and she had all of the symptoms that were on the paper besides the rash. The patient did not require emergency room and physician office visit. On an unknown date in 2021 breathing difficult, Heart racing, Feeling unwell, Tired, Felt queasy, Dizziness, blood sugar was low recovered. On 27Feb2021 sore left arm recovered. Caller would like to know if it is typical to experience side effects four days after receiving a dose of the Pfizer vaccine. Caller stated that she was home when she experienced the side effects and felt like a wet noodle and just wanted to lay down and did not seek medical attention. Caller did not clarify what the other number was that she had called and was directed to Pfizer DSU, but stated she had not made any reports previously. Caller does not have an email for her doctor at this time. She said she has not called him. She felt sick yesterday. Her cousin wanted her to go to the hospital but she said she can not do it as she could not breath good and just wanted to lie down. She was so weak. Caller mentioned that she was a little chubby, but she exercises and moves around a lot. Caller stated that she was not feeling good but went on because she has a life to live and go on with things. Caller stated she was taking Prednisone when she received her second Covid vaccination and she wondered if that had anything to do with her reaction. The patient took Excedrin Migraine for headache took Saturday, caller was unaware of dose she took. She stated that it was just over the counter. The Excedrin Migraine expiration date 21Dec and Lot SP2W, but she stated that she usually just takes Tylenol. Caller Mentioned taking normal vitamins daily and I Caps, she stated she feels like she does well for her age, and then restated that she does Damn well for her age. Caller states her family has heart disease issues during Vaccine supplemental form but continued to stated that she does not feel that was relevant to this report. Follow-up attempts were completed. No further information was expected.
78 2021-01-07 tremor EVENING OF 1/6/21, DEVELOPED TREMORS AND DIZZINESS. UNKNOWN DURATION, BUT IS RESOLVED NOW.
78 2021-01-08 pain in extremity, unresponsive to stimuli Patient was unresponsive in her room during the night, had gotten the vaccine this morning, 911 call... Read more
Patient was unresponsive in her room during the night, had gotten the vaccine this morning, 911 called. Had right arm pain and loss of consciousness. EMS got 180/104 BP and blood glucose was 122. Was transported to hospital. Returned to the facility the next day with no complications, was just fatigued.
78 2021-01-09 weakness Tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell, nausea, weakness
78 2021-01-12 numbness Bleariness, slight brain fog, not steady, legs feel like that they're not attached to body.
78 2021-01-14 tingling After receiving the COVID0-19 vaccine, client verbalized facial tingling. Client was evaluated by o... Read more
After receiving the COVID0-19 vaccine, client verbalized facial tingling. Client was evaluated by onsite paramedics and released at 4:56 pm to go home
78 2021-01-18 feeling hot Client verbalize feeling hot and sweaty after taking the vaccination. Client was evaluated by onsit... Read more
Client verbalize feeling hot and sweaty after taking the vaccination. Client was evaluated by onsite Fire Rescue and released to go home at 2:38 pm.
78 2021-01-18 pain in extremity Patient stated she has had anaphylactic reaction to a flu vaccine a couple months ago. Patient state... Read more
Patient stated she has had anaphylactic reaction to a flu vaccine a couple months ago. Patient stated she spoke with her physician and he still recommend her to receive the COVID-19 vaccine today. Discussed premedication; however, patient stated that doesn't work. Patient was observed for 30 minutes. After that time, patient stated to the observer , RN her left arm "hurt all the way down" and "chest felts heavy". Encouraged patient to go to ED, but patient declined. Nurse assessed patient who then felt short of breath. , RN took patient, via wheelchair, to ED. Husband was with patient. ED triage took patient back and husband checked in patient.
78 2021-01-18 pain in extremity Patient stated she has had anaphylactic reaction to a flu vaccine a couple of months ago. Patient s... Read more
Patient stated she has had anaphylactic reaction to a flu vaccine a couple of months ago. Patient stated she spoke with her physician and he still recommend her to receive the COVID-19 vaccine today. Discussed pre-medication; however, patient stated that doesn't work. Patient was observed for 30 minutes. After that time, patient stated to the observer RN her left arm hurt all the way down and chest felts heavy . Encouraged patient to go to ED, but patient declined. Nurse assessed patient who then felt short of breath. RN , took patient, via wheelchair, to ED. Husband was with patient. ED triage took patient back and husband checked in patient.
78 2021-01-20 unresponsive to stimuli At approximately 930am I arrived at Memory Care. I met with the director of the facility and she di... Read more
At approximately 930am I arrived at Memory Care. I met with the director of the facility and she directed me to where my team would be setting up. My team consisted of (technician), (nurse) and I. As we were setting up, the director asked how she can help. I explained to her that we would need a designated area for patients to be monitored after vaccination for 15 minutes and maybe even longer . I also explained that we would need one of her staff monitoring while we vaccinate. She agreed, and proceeded to designate her staff and the cafeteria area, facing the vaccination station,the monitoring station. Throughout the day, nurse and I were both vaccinating,while the staff of the facility would monitor the vaccinated patients. I would also stop occasionally to mix the vaccine and check the temperature of the aero safe. At approximately 12:50pm, the director rushed in and stated that a patient is not responding, and that she had been vaccinated. At that point, I grabbed epipens and a thermometer and I also instructed nurse to grab an Epipen and come with me. We followed the director to pt's room. Once we got to the room, the patient was in bed and there were 4 staff members standing bedside and one of them turned and stated the patient has passed. At that point I asked the staff how long ago did the patient get the vaccine, they stated about 30 minutes ago. They also stated that the patient was a hospice patient and that the patient had declined, and was rapidly detiorating and had not eaten or drank anything all day . They also stated that the patient had been monitored for 15 minutes post vaccination. I then left the room and grabbed the patients COVID Vaccine intake consent form. I looked at the answered questionaire and all the responses were circled NO. Patient had a temp of 96.5 at the time of vaccination.The vaccine administration information for Immunizer Section was filled out by Nurse. I then proceeded to ask the director once again if there were staff that was monitoring her for 15 minutes, the director stated they had staff monitoring her. She also stated the Hospice nurse has to announce her death, so they waited for the Hospice Nurse to come. I then called Corporate and explained the situation. After speaking to corporate, I also asked nurse, if she remembered the patient. She stated that she did and at the time of the vaccination the patient was not alert, there were two staff members with the patient. She was non oriented and she kept closing her eyes. At that point, Nurse stated that she asked the two staff members with her if this is how she usually is and if its ok to vaccinate her. Both Staff members stated that it its ok,this is how she is. The Nurse then proceeded to vaccinate. At approximately 3:10pm, as I was leaving I spoke to the director, and one of her Staff members. Staff that the patient has actually not eaten/ or drank anything for the past several days, including today(01/18/21). Staff also stated that on Friday, Jan 15th,2021, they had informed the family that the patient was rapidly detiorating. Staff also stated that the family knowingly gave the consent to vaccinate her. She also stated that the hospice Nurse believes that the death was primarily caused by her detiorating state. She also stated that the hospice Nurse informed that the death was not due to the Vaccine. Per Lead Pharmacist at the clinic.
78 2021-01-21 flushing Patient reports feeling flushed and lips/tongue tingling. Physical examination in the emergency depa... Read more
Patient reports feeling flushed and lips/tongue tingling. Physical examination in the emergency department noted as normal. Patient given diphenhydramine 25 mg orally with resolution of symptoms.
78 2021-01-21 flushing Patient reports feeling flushed and lips/tongue tingling. Patient transported to the emergency depar... Read more
Patient reports feeling flushed and lips/tongue tingling. Patient transported to the emergency department for evaluation. Physical exam noted as normal and no tongue or lip swelling. Patient administered 25 mg diphenhydramine orally and observed for 2 hours.
78 2021-01-21 pain in extremity When I awoke this morning and was getting dressed, I noticed a soreness in the back of my left leg (... Read more
When I awoke this morning and was getting dressed, I noticed a soreness in the back of my left leg (on the right side of the left leg). I felt a lump, It was about 2-3 inches above the knee. It was what I would describe as a medium-sized lump. I called my doctor to leave a message about my symptoms. My doctor called a few minutes after 11 am and asked me to immediately come in so he could see the lump. He thought I might have a blood clot. This lump was not present late last night because when I put lotion on my legs after my shower, I felt no lump or soreness. I worked out this morning and by 11:00, it seemed to me the lump was not as big as it was when I was getting dressed earlier this morning.
78 2021-01-21 tingling, weakness CDizzy. Weak after an hour, increasing so could barely stand by 8 pm. severe abdoominal pain, chill... Read more
CDizzy. Weak after an hour, increasing so could barely stand by 8 pm. severe abdoominal pain, chills, throat swelling during night, feeling as id needles pricking entire body for an hour or so around 2 or 3 am. Better next day exvept tired and weak. Ok since then.
78 2021-01-21 tenderness TENDERNESS AND SORENESS
78 2021-01-24 pain in extremity began to ache 2 pm of day of vacination, could not sleep. shooting pain ears, hands, head, much wo... Read more
began to ache 2 pm of day of vacination, could not sleep. shooting pain ears, hands, head, much worse than 1st shot
78 2021-01-26 numbness Right facial numbness the day following first injection. Now 2 weeks late still have facial numbnes... Read more
Right facial numbness the day following first injection. Now 2 weeks late still have facial numbness
78 2021-01-28 weakness felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fas... Read more
felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fast heart rate (100 bpm); low grade fever; felt very weak; pleuralpericardial effusion; pleuralpericardial effusion; This is a spontaneous report from a contactable consumer. A non-pregnant 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 16Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included allergic to opioids, allergy to fish, cirrhosis with portal hypertension, parkinsonism, heart blockage, type 2 diabetes, depression, early dementia. The patient previously took morphine and experienced drug hypersensitivity. There was unspecified concomitant medication. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced allergic to morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced felt tired, nausea, headache, short of breath, rapid/shallow breathing, fast heart rate (100 bpm), low grade fever, felt very weak, pleuralpericardial effusion on 16Jan2021. All the events were reported with the seriousness criteria of disability, hospitalization and being life-threatening. The patient was hospitalized for the events for 4 days. After the injection, from 0 to 24 hours the patient felt tired, had nausea, a headache, short of breath then at about 24 hours post injection developed rapid/shallow breathing, fast heart rate (100 bpm) low grade fever and felt very weak. The patent was taken to the emergency room (ER) at 30 hours post injection and it was determined (Xray, CTA & EKG) that she had a pleuralpericardial effusion. She was flown by air life to another ER for treatment. The patient underwent lab tests and procedures on 16Jan2021 which included angiogram (CTA): had a pleuralpericardial effusion; body temperature: low grade fever; electrocardiogram (EKG): had a pleuralpericardial effusion; heart rate: 100 beats per minute (bpm); X-ray: had a pleuralpericardial effusion. The patient had a rapid nasal swab on 17Jan2021 which was negative. Therapeutic measures were taken as a result of the events and included unspecified medications & oxygen therapy. The outcome of the events was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
78 2021-01-28 feeling hot She has shrunk; weighs less. Maybe 154 pounds. She was 170; she got first dose of Pfizer COVID vacci... Read more
She has shrunk; weighs less. Maybe 154 pounds. She was 170; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; had congestion; Coughing; choking; body was more than hot it was burning/body turned very hot; could not sleep/two sleepless nights; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization, ciprofloxacin (CIPRO), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication and pirfenidone (ESBRIET), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. Medical history included pulmonary fibrosis (diagnosed between 2007-2010), Lymphoma type B, blood pressure (abnormal), cholesterol (abnormal), vertigo, biopsy, tightening of legs and feet, drip (nasal) and pain. Concomitant medication included gabapentin for tightening of her legs and feet, diphenhydramine hydrochloride (BENADRYL) for drip (nasal) and meloxicam for pain. It was reported that the patient took the vaccine and had two sleepless nights on 05Jan2021, her body turned very hot but she have some conditions. Sleepless nights: they have been really rough nights. Scary. Coughing and choking. She thinks the vaccine kicked in and started beating the hell out of it. The patient clarified that she is having sleepless nights because of the coughing, choking, and burning and she feels that it is related to the vaccine kicking in. She slept last night, 14Jan2021. The cough is starting again today (as reported). She hopes it calms down. When she said her body was hot, like burning she was describing her sleepless nights. She is afraid. She is keeping in contact with her doctor. She figured she better call because more people are on this medication. The patient also experienced congestion on 06Jan2021. It was reported that the patient has shrunk and weighed less. Maybe 154 pounds. She was 170. The action taken for ciprofloxacin and pirfenidone was unknown. The outcome of the event congestion was not recovered, while unknown for the rest of the events.
78 2021-01-28 feeling hot Chills; feeling very hot; arm also swelled, about 3 inches around the site; arm also swelled, about ... Read more
Chills; feeling very hot; arm also swelled, about 3 inches around the site; arm also swelled, about 3 inches around the site/ it was red and itchy; arm also swelled, about 3 inches around the site/ it was red and itchy; she woke up in a horrible sweat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1284, expiry date: 30Apr2021), via an unspecified route of administration upper arm probably only about 4inches down from shoulder blade on the left on 12Jan2021 18:00 at a single dose for COVID-19 immunization. Medical history included COVID on 01Oct2020. Concomitant medication included rivaroxaban (XARELTO) as blood thinner. The patient previously took a flu and shingles shot and experienced her redness and swelling on her arm. The patient did not have vaccinations four weeks prior, and no additional vaccines were administered on the same date. She got it because she was told by her doctor that her antibodies will not last forever and it was still necessary to get it even though she already had COVID antibodies. She contracted COVID on 01Oct2020, that was the date when she had a positive test then she was last tested in December and she still had the antibodies then. She received her first dose of the vaccine on Tuesday 12Jan2021 and 24 hours later on 13Jan2021, she experienced chills and feeling very hot, which she took Tylenol extra strength for and it disappeared the next day. Her arm also swelled, not the whole arm, she would say about 3 inches around the site, 4 inches at the most and it was still swollen, it was red and itchy. Then she woke up in a horrible sweat but by the following morning it was gone. She wouldn't say it was a horrible reaction but she wanted to be certain she can go ahead and get the second shot which she had an appointment for. She said everything has resolved completely except for the swelling, her arm was still swollen, itchy, and red. Since the swelling, redness and itchiness began she would say it was slightly better than it was. The patient received the vaccine at an independent assisted living facility, not a military facility. The adverse events did not require a visit to the emergency room or physician's office. Outcome of the events chills, feeling very hot and woke up in a horrible sweat was recovered on 14Jan2021, while the remaining events was recovering.
78 2021-01-28 numbness Right side facial numbness; This is a spontaneous report from a contactable consumer (patient). A 78... Read more
Right side facial numbness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL1284, expiration date unknown), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. The patient's medical history included hypothyroidism and coronary artery disease. Concomitant medication included atorvastatin (LIPITOR), levothyroxine sodium (SYNTHROID), famotidine (PEPCID), and acetylsalicylic acid (BABY ASPIRIN). The reporter was reporting a side for "COVID-19 the Pfizer shot" which she received on 13Jan2021. On an unspecified date, she experienced facial numbness, right side facial numbness. She went to the emergency care on 15Jan2021, no treatment received. The outcome of the event was unknown.
78 2021-01-29 pain in extremity Debilitating pain and swelling at vaccination site with a ring around the shot. Pain then transferr... Read more
Debilitating pain and swelling at vaccination site with a ring around the shot. Pain then transferred to other arm with body aches and low grade fever. Pain at shot site duration was 10 days with no relieving factors.
78 2021-01-31 weakness, pain in extremity Intense headaches starting night of injection, lasted for days. I felt weak, pains in my legs ankles... Read more
Intense headaches starting night of injection, lasted for days. I felt weak, pains in my legs ankles and arches. Stomach pain, and feeling lethargic. I took Tylenol but i think that disturbed my stomach. Still having soreness in my legs and ankles and still don't have energy today.
78 2021-01-31 weakness On 1/9/21-Diaphoresis, O2 90%, respirations 22, increased weakness, wheezing bilaterally. Send to ER... Read more
On 1/9/21-Diaphoresis, O2 90%, respirations 22, increased weakness, wheezing bilaterally. Send to ER for evaluation and treatment. She was sent to ER, where she was admitted for 2 days, then expired there on 1/11/21
78 2021-01-31 difficulty speaking 1/27/2021- Fatigue 1/28/2021 around 2 AM- Coughing, Difficulty breathing had to use breathing machin... Read more
1/27/2021- Fatigue 1/28/2021 around 2 AM- Coughing, Difficulty breathing had to use breathing machine and inhaler, hoarse voice, fatigue. Ended up sleeping over 12 hours Went to lung doctor 1/29/2021- Still feeling same symptoms as 1/28/2021. Said had an adverse reaction to vaccine, prescribed to keep using inhaler and breathing treatments as needed, also prescribed AZITHROMYCIN 1/30/2021- Started to feel a little better, not as hoarse. 1/31/2021- Significantly Better than before. Still coughing 2/1/2021- About 70% better still coughing a little but improved
78 2021-01-31 flushing Injection time 1302. Symptoms: Lightheaded and flushed. Per pt's daughter, felt symptoms around 1325... Read more
Injection time 1302. Symptoms: Lightheaded and flushed. Per pt's daughter, felt symptoms around 1325. Pt. has history of diabetes and also currently taking antibiotics for UTI. BP 110/78. Symptoms improved 1335. Observed pt. until 1355. Pt. is feeling better and in stable condition at the time she left.
78 2021-01-31 pain in extremity, numbness Body aches, low gr. temp. aches into her buttocks area down back of post. thighs. She did have Covid... Read more
Body aches, low gr. temp. aches into her buttocks area down back of post. thighs. She did have Covid infection in Sept 2020. Meds admin - NaCl 0.9% I.V. bolus. 500 ml. Tyl. + Hydrocodone 650/25 - Labs - UA. lactic acid, SARS antigen, BMP, CBC, CXR - revealed pneumonia - F/U with family practice on Monday. In addition to above - numbness from waist down to toes, loss of bowel + bladder. T-102.F. Unable to walk - this lasted for 17 hrs.
78 2021-01-31 pain in extremity Around the site of injection, it was like a red circle like a size of an inch; I felt like a little ... Read more
Around the site of injection, it was like a red circle like a size of an inch; I felt like a little warm to me; Around the site of injection, it was like a red circle like a size of an inch; I felt like a little warm to me; She didn't know what but it is itchy, it hurts or a combination of both; She didn't know what but it is itchy, it hurts or a combination of both; My arm hurts/her arm felt like a little sore; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) via an unspecified route of administration, on 06Jan2021 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medications included metoprolol and lisinopril, both for high blood pressure. Patient stated that she got the Pfizer vaccine on 06Jan2021. The regular reaction to it like her arm hurts and that was it, it lasted like for three days and it went away. Not yesterday, but the day before (15Jan2021), her arm felt like a little sore. Yesterday (16Jan2021), when she was in the showering, she noticed that the around the site of injection, it was like a red circle like a size of an inch that was (sentence incomplete). She felt like a little warm to her. She didn't know what but it was itchy, it hurt or a combination of both, it didn't bother her unless she touched it or rubbed against it but it was there. So, she just wanted to know whether that was a reaction to the injection or what that was, is that common or is that not common. Patient said she still felt it. As treatment, patient took a paracetamol (TYLENOL). She took one paracetamol this morning (17Jan2021) and one yesterday (16Jan2021). Outcome of arm hurts/arm felt like a little sore was recovered, outcome of other events was not recovered.
78 2021-01-31 tingling, numbness Patient states she was feeling dizzy and was advised to stay for observation. Patient states that s... Read more
Patient states she was feeling dizzy and was advised to stay for observation. Patient states that she was feeling better and decided leave ,but upon leaving, she felt dizzy again and started having left sided numbness and tingling in her hand and leg. patient vitals were taken 165/71 P84 02 99%. Patient states having history of stroke and HTN and blood pressures medications. Patient was transferred to the ED for observation and evaluation via w/c.
78 2021-01-31 speech disorder Headache; Dizziness/Lightheaded; Gait and speech disturbance; Gait and speech disturbance; Tired; Br... Read more
Headache; Dizziness/Lightheaded; Gait and speech disturbance; Gait and speech disturbance; Tired; Brain fog; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 16Jan2021 14:30 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history included Sjogren's, asthma, low Igg, A-Fib, osteoporosis. The patient has known allergies: Methylparaben, Rocephin, lidocaine, oats. Concomitant medications included metoprolol, hydroxychloroquine sulfate (PLAQUENIL), apixaban (ELIQUIS), propafenone. On 16Jan2021 14:30, the patient experienced Headache, dizziness, lightheaded, gait and speech Disturbance, tired, brain fog. The outcome of the events was unknown. The patient did not receive treatment for the events. Information on the lot/batch number has been requested.
78 2021-01-31 tremor I felt fine the day of the vaccine but I woke up at 3:45 AM. I was so cold that I was shaking, I ac... Read more
I felt fine the day of the vaccine but I woke up at 3:45 AM. I was so cold that I was shaking, I ached all over. When I got up my temperature was 102 and in stayed between 101.5 and just over 102 for about 30 hours. I also had cold like symptoms, a cough and diarrhea. It wasn't until 48 hours after the shot that my temperature was normal.
78 2021-02-03 involuntary muscle movements, muscle twitching, seizure Approximately 10 minutes after receiving the COVID- 19 vaccine resident displayed seizure activity, ... Read more
Approximately 10 minutes after receiving the COVID- 19 vaccine resident displayed seizure activity, staring straight ahead and strong allover muscle jerking of both the up and lower extremities, color became gray, activity lasted approximately 3 minutes, resident then became relaxed, color returned to normal, BP-140/80, 97.8, 60, 16, sleeping the remainder of the shift,. Resident continued to decline until resident CTB on 1/19/21
78 2021-02-03 tingling Tingling in left hand from time of injection
78 2021-02-03 tremor About 7-10 minutes after receiving the shot, patient started to feel extremely shaky and warm. Her f... Read more
About 7-10 minutes after receiving the shot, patient started to feel extremely shaky and warm. Her face turned red and hands were shaking. Patient felt her heart skipping with irregular heart beats. The nurse measured the patient's blood pressure and it was 183/95 with a pulse of 104. The patient was observed for an hour.
78 2021-02-04 unresponsive to stimuli view 2/5/2021 09:23 e Progress Note Note Text: Patient passed away in the facility this morning.... Read more
view 2/5/2021 09:23 e Progress Note Note Text: Patient passed away in the facility this morning. view 2/5/2021 08:39 Orders - Administration Note Note Text: Resident passed. view 2/5/2021 08:33 Nurses Note Note Text: Body released to funeral home at this time. Personal effects sent with resident include: 1 pair of glasses, 1 yellow wedding band, 1silver spoon ring, 1 ring with black and clear stones. Resident has own teeth view 2/5/2021 08:32 Nurses Note Note Text: cause of death per CRNP failure to thrive. view 2/5/2021 07:44 Orders - Administration Note Note Text: Take and document temp & PO2 every 4 hours for MONITORING Resident passed. view 2/5/2021 06:49 Nurses Note Note Text: Son returned call and was updated of resident's passing this am view 2/5/2021 06:33 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Unknown Resident expired @ 0604 [linked] view 2/5/2021 06:06 Nurses Note Note Text: Res found without pulse or respirations. Pronounced at 0604. Updated. N/o's for RN to pronounce, release body to funeral home, dispose of medications per facility policy. Daughter updated. Funeral Home called to release body. view 2/5/2021 05:26 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger Pulse ox 60% on O2 @ 5L/min via mask. Resps 44 per minute. view 2/5/2021 01:57 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Effective Follow-up Pain Scale was: 2 [linked] view 2/5/2021 00:52 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger Residents resps are 40 per minute, pulse ox 76% on O2 @ 5L/min via mask. Resps are labored, shallow and rapid. view 2/5/2021 00:48 Nurses Note Note Text: Nonresponsive to verbal and tactile stimulation. Appears comfortable. view 2/4/2021 22:01 Nurses Note Note Text: Resident resting comfortably, breathing becoming increasingly shallow, wearing O2 via mask at 5L via mask, no dyspnea noted, feet are mottled, oral and peri care provided Q2H. No s/s of pain or discomfort. view 2/4/2021 21:40 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Effective [linked] view 2/4/2021 19:32 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger medicated for air hunger, RR 28 to 32/ min view 2/4/2021 19:22 Nurses Note Note Text: Daughter updated on N/O to increase Morphine Sulfate 20mg/mL 0.25mL to Q2H prn from Q6H prn. view 2/4/2021 18:06 Nurses Note Note Text: POA Daughter and daughter aware of residents current condition. view 2/4/2021 11:58 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN Administration was: Effective Follow-up Pain Scale was: 2 [linked] view 2/4/2021 11:13 Nurses Note Note Text: Pt. noted to be lethargic at this time. Does respond to verbal and tactile stimuli by opening her eyes but non verbal currently. Skin warm and dry. No mottling or apnea observed at this time. O2 sat 88% with O2 at 2 LPM via n/c. On increased to 3 LPM via mask as pt. noted to be mouth breathing. Respirations 28. F/U O2 sat 93%. HOB elevated. Pt. medicated with morphine by LPN. Daughter updated on pt.'s condition. Does not want pt. sent out to hospital and would like comfort measures to continue. Daughter also in agreement with delay in d/c d/t pt.'s condition.CRNP updated on pt.'s condition, delay in d/c and daughter's wishes. No n/o's at this time. view 2/4/2021 10:56 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB Resident showing s/s of discomfort. SOB at this time and high respirations. Repositioned, changed for incontinence care and mouth care provided. view 2/4/2021 10:34 Progress Note Note Text: Spoke with RN regarding change in condition. Updated Sr Living regarding change. Recommendation to cancel d/c/transfer for today, see how resident does through the weekend and re-evaluate on Monday. Daughter updated on cancellation of d/c today. view 2/4/2021 10:04 Nurses Note Note Text: Daughter aware that resident's O2 sat was 88% on room air on 3-11 shift and that oxygen was applied via nasal cannula. view 2/4/2021 10:03 Nurses Note Note Text: N/O: Discharge 2/4/21 with scripts to Sr. Living. Daughter aware. view 2/4/2021 09:53 Nurses Note Note Text: Pt. to be d/c'd to another facility this am as per MD order. Pt. alert and responsive. Skin assessment done as per facility policy. No pressure areas noted at this time. No s/sx of pain or discomfort observed at this time. V.S. 97.0 67 20 O2 sat 95% with O2 at 2 LPM via n/c. view 2/4/2021 07:45 Nurses Note Note Text: Resident seen by Dr. for discharge. Orders pending at this time. view 2/4/2021 07:36 Nurses Note Note Text: CRNP and Dr. updated on O2 sat 88% on RA with f/u of 93% with O2 on at 2 LPM as well as rest of VS, 3-11 shift 2/3/21. No n/o's at this time. view 2/3/2021 21:17 Nurses Note Note Text: Resident Sp02 88% on RA. Pulse 124. Respirations 40. PRN morphine given and O2 applied via NC at 2L/min. After recheck pulse ox up to 93%, pulse 100, and respirations 22. Resident appears comfortable at this time. view 2/3/2021 20:05 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN Administration was: Effective [linked] view 2/3/2021 19:48 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN given for SOB after elevation of HOB not effective. view 2/3/2021 11:51 Nurses Note Note Text: CRNP updated rapid COVID test done for d/c tomorrow was negative. No n/o's at this time. view 2/3/2021 11:44 Nurses Note Note Text: Daughter notified of rapid covid swab being negative. view 2/3/2021 09:50 Orders - Administration Note Note Text: Obtain Rapid Covid test on 2/3/2021 for discharge. Please give copy of results to Social Worker every day shift for covid testing for 1 Day Completed and negative. view 2/3/2021 08:45 Skilled Nursing Note Reason for skilled service: Therapy describe skilled service: Nursing, therapy assessment: V.S. 97.8 79 18 138/84 Orientation: Oriented to self only. Oxygen: O2 sat 94% on RA Edema: Trace edema noted BLE. Pedal pulses present. Pain: Denies pain or discomfort at this time. Nursing note: Pt. alert and responsive. Skin warm and dry. Lung sounds diminished. No respiratory distress observed at this time. Abdomen soft. BS+ in all 4 quads. Continent/Incontinent of B&B. 1 assist with ambulation, transfers. 1 assist with ADL's. Working with therapy on gait training, therapeutic exercise, therapeutic activities & neuromuscular reeducation. view 2/2/2021 14:37 Progress Note Note Text: Per health professional at Sr Living, prepared to accept patient to their Memory Care Unit 2/4. Transportation arranged for 11 AM per family request. Daughter (POA) updated on d/c time on 2/4/21. Facility requesting rapid COVID test completed prior to d/c and results sent to them. All other information sent for continuity of care.
78 2021-02-05 weakness Headache; Chills; cognitive confusion, serious and unprecedented; extreme fatigue; weakness; nausea.... Read more
Headache; Chills; cognitive confusion, serious and unprecedented; extreme fatigue; weakness; nausea. These symptoms have continued to the present, 2/6/2021.
78 2021-02-05 unresponsive to stimuli AMS-Fever-UTI-myoclonic jerks-unresponsive <6hrs post 1st covid vaccine. AMS-UTI- post 2nd covid vac... Read more
AMS-Fever-UTI-myoclonic jerks-unresponsive <6hrs post 1st covid vaccine. AMS-UTI- post 2nd covid vaccine
78 2021-02-07 weakness, feeling cold I began feeling weak around 3:15 and was worse by 4 PM. Then I began having shivers but no temp. I f... Read more
I began feeling weak around 3:15 and was worse by 4 PM. Then I began having shivers but no temp. I felt weak and pulse raced as soon as I got up and walked around. Some aches and pains and malaise but I slept all night. Next day still felt poorly but no chills. Got a cold spell towards evening bu lasted about 1 hr. Some slight congestions that was relieved with a good cough maybe twice a day for another couple of days. That is all.
78 2021-02-07 burning sensation, hot flush, discomfort About 10 minutes after receiving the covid vaccine, I developed a red flush on my face which was bri... Read more
About 10 minutes after receiving the covid vaccine, I developed a red flush on my face which was bright, hot and uncomfortable. The flush appeared nowhere else on my body so I concluded that the vaccine must have interacted with the tretinoin cream I use nightly. That is the only area of my skin on which i apply the cream. When I got home, I applied soothing skin cream but no relief. I then tried aloe, which grows in the area, and the flush/burning abated somewhat. The next day, my face was still flushed but less red. the skin surface was scaly. I am continuing to treat at home. No MDs involved.
78 2021-02-07 discomfort Around 3:50pm patient had complaint of heart jumping. Heart rate was initially 104, after 30 minutes... Read more
Around 3:50pm patient had complaint of heart jumping. Heart rate was initially 104, after 30 minutes rest, coached deep breathing, heart rate 90 regular. Patient was persistently uncomfortable and tachycardic and requested EMS evaluation. Responding EMS checked EKG, glucose, BP (etc) and released. Patient seemed to have moderate reaction to vaccine.
78 2021-02-07 tingling Immediate tingling throughout my body when injection started. Stayed 25 min. in clinic following ... Read more
Immediate tingling throughout my body when injection started. Stayed 25 min. in clinic following injection. Tingling remained but no breathing problems developed. Tingling lessened by next morning. Did have increased aches and pain sand more headaches on day 2. Contacted MD on Fec. 2 and she was aware of others having the full body tingling but said she thought it was OK to get 2nd dose Feb. 20.
78 2021-02-07 unresponsive to stimuli lot not documented in EMR Call center call from adult son queryi8ng if symptoms were vaccine relate... Read more
lot not documented in EMR Call center call from adult son queryi8ng if symptoms were vaccine related.. Reported 78 yo mother awoke restless, agitated, could not describe what was wrong. She was Audibly moaning in the background, had difficulty responding to his instructions. Assessment revealed FSBG of 27. corrected with oral juice. Assessment after recovery did not identify any change in habits, had not missed meals, changed medications and is not on insulin; has no history of similar events.
78 2021-02-08 weakness A little weak at bedtime (Saturday) Next morning Strong toothache upper back left teeth, slight swe... Read more
A little weak at bedtime (Saturday) Next morning Strong toothache upper back left teeth, slight swelling/itching lower left side of mouth/chin area (Sunday) Pain all day (Monday) Feels like teeth are in a vice, swelling left side of roof of mouth
78 2021-02-08 weakness little depressed; not feeling like herself; weak; tired; This is a spontaneous report from a contact... Read more
little depressed; not feeling like herself; weak; tired; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiry date unknown), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient received the first dose on the left arm on 19Dec2020 10:30 (lot number: EL0140). Medical history included hypertension. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no side effects after the first vaccine except for a little tenderness which went away. On 11Jan2021, after receiving the second dose, she felt really tired but which went away. On 20Jan2021 (last Wednesday), she started to feel tired, weak, and not feeling like herself. On 22Jan2021, the patient was a little depressed. She did not have a headache. Her blood pressure was fine and she never had a fever. She had an X-ray back in Sep2020. Her vision is good. She is not hurting anywhere. She doesn't feel as strong. She doesn't understand the tiredness, weakness, and depression. Outcome of the event tired was recovered on 11Jan2021, of the events doesn't feel like herself and weak was not recovered, and of the event depression was recovering. The reporter assessed all the events as related to the bnt162b2. The events depression and doesn't feel like herself were reported as serious: medically significant while the other events were reported as non-serious.; Sender's Comments: A possible contributory role of bnt162b2 in triggering the onset depression and doesn't feel like herself cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
78 2021-02-10 discomfort Exhaustion onset about 8:00 PM 1/26/21 lasting over 36 hours before starting to feel better. I lite... Read more
Exhaustion onset about 8:00 PM 1/26/21 lasting over 36 hours before starting to feel better. I literally slept all of the next day only getting up occasionally and most of the day after that. I started to become more normal feeling the late afternoon of 1/28/21. I also felt very stiff and uncomfortable. Sore neck and joint pain and a slight headache. I had a sore area across my arm (felt like a bruise although there was no discoloration) about 1 inch inch below the injection sight which was on my upper left arm. That persisted for several days. I slept and took 1 800 mg Ibuprofen (on 1/27/2021). Am feeling better but still not feeling 100 %. That may be due to increased allergies due to time of year of etc a
78 2021-02-10 pain in extremity Bilateral upper arms reddened, swollen and pain resident also presented with a temperature. No trea... Read more
Bilateral upper arms reddened, swollen and pain resident also presented with a temperature. No treatment rendered for the localized reaction however antipyretic medication given and resolution of temperature achieved. Primary care physician ordered allergy to the COVID-19 vaccine.
78 2021-02-10 tenderness She had no side effects after the first vaccine and was tender on the first day, which went away; Th... Read more
She had no side effects after the first vaccine and was tender on the first day, which went away; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0140 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 19Dec2020 10:30 at single dose for Covid-19 immunization. The patient's medical history included hypertension. The patient had an X-ray back in Sep2020 (unknown result). The patient's concomitant medications were not reported. On 19Dec2020, the patient had the first dose and stated that she had no side effects after first vaccine and was tender on the first day which went away. The outcome of the event was recovered on 20Dec2020. The event was treated with unspecified treatment. The reporter assesses the event as non-serious.
78 2021-02-10 unresponsive to stimuli Felt faint and lightheaded thirteen minutes after receiving shot. Hypotension down to Systolic Blood... Read more
Felt faint and lightheaded thirteen minutes after receiving shot. Hypotension down to Systolic Blood pressure of 72. Became unresponsive; EpiPen used. Patient improved. Taken by paramedics to emergency department
78 2021-02-11 flushing, burning sensation Significant facial flushing and burning sensation that developed just hours after administration. Po... Read more
Significant facial flushing and burning sensation that developed just hours after administration. Possibly febrile during this episode. No reaction from first vaccine. Has had similar reaction to other medications and possibly a previous vaccine but patient is not certain. On day three saw provider with symptoms improved. No treatment needed. Monitoring.
78 2021-02-12 weakness Vomiting 4 times after feeling nauseous and weak with head and body aches for 2 days
78 2021-02-14 fibromyalgia Severe exacerbation of fibromyalgia for 3 days and itching at the injection site
78 2021-02-15 weakness Fever over 100 degrees, muscle aches and joint pains, general weakness and malaise, at approximately... Read more
Fever over 100 degrees, muscle aches and joint pains, general weakness and malaise, at approximately 20 hours after injection, until about 30 hours after.
78 2021-02-15 bell's palsy, facial paralysis Bell's Palsy diagnose 2/5/2021 and treated with Prednisone and antiviral. Has history of Bell's pal... Read more
Bell's Palsy diagnose 2/5/2021 and treated with Prednisone and antiviral. Has history of Bell's palsy in the past. She started with right sided facial droop and was choking with swallowing.
78 2021-02-15 feeling hot, tremor After vaccine a feeling of something going thru my body. Got very hot and dizzy. Sat in chair and ... Read more
After vaccine a feeling of something going thru my body. Got very hot and dizzy. Sat in chair and nurse took my blood pressure which spiked to 208. I was shaking and my heart was pounding. I was rushed to the emergency room. Put on IV, Heart monitor, lung x-ray and blood test. Blood pressure was still at 188 at 2:00 PM. Asked to leave at 3:00 PM, I still did not feel good but I needed to get home, because my husband was home my himself and very upset. I am his caretaker. My pressure dropped to 158 at 10:00PM I had bad headaches for 4 days and I still get them once in a while. I do not have high blood pressure, my blood pressure is usually between 120 - 130.
78 2021-02-16 facial pain Vacinne given left arm 2/2/2021 3 days later Fri. 2/5 I left side of my face developed a sore fa... Read more
Vacinne given left arm 2/2/2021 3 days later Fri. 2/5 I left side of my face developed a sore face began to swell all way to my mouth.I've had cellulitis in the past. Began taking Kleflex saw my general medicine who advised me to contact your office
78 2021-02-16 feeling hot, weakness, muscle spasms Received shot on Friday, February 12 around 1PM. Saturday, February 13:Approximately 30 hours after... Read more
Received shot on Friday, February 12 around 1PM. Saturday, February 13:Approximately 30 hours after receiving shot, 8:00 pm, Saturday, Feb 13, developed stomach cramps. Over the next 4/5 hours, diarrhea, vomiting, cramps, chills. Felt very hot at times, but never ran a fever. Sunday, February 14, felt tired and weak, periodic cramps. No nausea or diarrhea. Monday, February 15, more energy, some cramps, By
78 2021-02-16 flushing Pt felt flushed, had a HA and was dizzy. Was taken to first aid and medic reported pt BP 200/99 seve... Read more
Pt felt flushed, had a HA and was dizzy. Was taken to first aid and medic reported pt BP 200/99 several times. Pt transported to ER for high BP and dizziness
78 2021-02-17 feeling hot, nerve pain, tingling I had right knee replacement surgery in 2018 and developed severe neuropathic pain in right leg . He... Read more
I had right knee replacement surgery in 2018 and developed severe neuropathic pain in right leg . He pain subsided with time . After I got vaccine the pain came got . Now I have tingling , electrical like feeling , hot foot. I am applying ice. It tweaks me up at night.It is annoying
78 2021-02-17 tingling 10 minutes after vaccination, patient noted onset of dizziness, feeling "strange", tingling in her l... Read more
10 minutes after vaccination, patient noted onset of dizziness, feeling "strange", tingling in her left hand, and palpitations. At 15 minutes after vaccination, her blood pressure was found to be 200/84 LA and HR90 . O2 sat 98% on RA. T 98.2 F. Pt remained alert and in no distress, but continued to feel dizzy and unwell. Her repeat blood pressure was 184/84. EMS was notified and patient was transported to the emergency room.
78 2021-02-17 speech disorder This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored program. ... Read more
This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored program. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 25Jan2021 at 13:00 (at 78 years) at single dose for COVID-19 immunization. The patient medical history included anxiety, headache, dry eye and low potassium, each from an unknown date and unknown if ongoing. The patient's concomitant medication included potassium oral at 10 meq daily for low potassium, cholecalciferol (D3) oral at 2000 iU once a day to help with bones, fish oil oral at 1200 mg once a day, alprazolam at 0.5 mg as needed (take one three times a day) for anxiety, clonazepam oral at 0.5 mg once a day for anxiety, nortriptyline HCl oral at 10 mg once a day, paracetamol (TYLENOL) at 500 mg as needed for headache, estradiol (SYSTEN) ophthalmic one drop as needed, all from an unknown date and ongoing. The patient experienced one or two hours after the vaccine (on 25Jan2021), she went to talk, she couldn't get her sentence straight. She knew what she wanted to say but she couldn't say it. Her first thought was that she was having a stroke and it really scared her. She became very tired and went to sleep, when she woke up, she was talking straight but she was still really tired. The next morning (on 26Jan2021) she had diarrhea three time and after that she felt better. The patient outcome of speech disorder and diarrhea was recovered on 26Jan2021 and the outcome of tiredness was recovering. The information on the batch number has been requested.
78 2021-02-18 muscle spasms RECEIVED PFIZER COVID19 VACCINE ON 02/14/21 PRESENTED TO THE ED ON 02/19/21 WITH ABDOMINAL PAIN (CRA... Read more
RECEIVED PFIZER COVID19 VACCINE ON 02/14/21 PRESENTED TO THE ED ON 02/19/21 WITH ABDOMINAL PAIN (CRAMP/ACHY PAIN) IN RIGHT LOWER QUADRANT X5 DAYS. DIAGNOSED WITH ACUTE ABDOMINAL PAIN IN THE RIGHT LOWER QUADRANT AND NON-INTRACTABLE VOMITING WITH NAUSEA. DISCHARGED FROM ED AND INSTRUCTED TO FOLLOW UP WITH PCP.
78 2021-02-19 weakness Malaise, weakness , headache, chills, severe abdominal pain, this continued through the night. Unabl... Read more
Malaise, weakness , headache, chills, severe abdominal pain, this continued through the night. Unable to sleep due to abdominal pain, considered calling ambulance. In morning, diarrhea, nausea, poor appetite. Now 2:30 pm. , pretty much recovered
78 2021-02-19 pain in extremity Pfzer-BioNTech Covie19 Vaccine EUA. Joint and muscle pain in neck, shoulders, lower back, buttocks,... Read more
Pfzer-BioNTech Covie19 Vaccine EUA. Joint and muscle pain in neck, shoulders, lower back, buttocks, legs.
78 2021-02-22 weakness 1/12/21 er HPI: HPI 78 y.o. female who presents with pain swelling and redness left wrist and hand a... Read more
1/12/21 er HPI: HPI 78 y.o. female who presents with pain swelling and redness left wrist and hand associated with fever according to EMS, but temperature in the ER is 98.4° F. patient was said to have fallen on 1/7/2021. *incidental finding bacterial pne* 1/12/21 admission History: The patient is a 78 y.o. female with a past medical history notable for Dementia, atrial fibrillation, CHF, diabetes, reflux. The patient presents for evaluation of Worsening issues of decline and trouble with breathing. Patient was evaluated the ER and found to have a urinary tract infection in addition to pneumonia. Due to patient's dementia history is difficult to take outside of history of which was taken for patient's nursing staff at skilled care facility. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed
78 2021-02-22 facial paralysis, slurring Double vision; the way she talked she kind of had slurred speech; mouth was dry; she had Bell's Pals... Read more
Double vision; the way she talked she kind of had slurred speech; mouth was dry; she had Bell's Palsy/ Droop in her lip/mouth; her eye was still watering; puffiness around her eye; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (manufacture unknown, Lot Number: 9264), intramuscularly in left arm on 29Jan2021 14:55 at 0.3 ml, single for COVID-19 immunization. Medical history included non-hodgkin's lymphoma from Jul2019 and ongoing (The first time she was diagnosed was Jul2019. She then went into remission and then got the cancer back, she doesn't know when. She knows they started treating it as the cancer had returned in Aug 2020), watering eyes from an unknown date and unknown if ongoing (Her eye was watering before the injection. She knows her eye was watering before she received the vaccine), chemotherapy from an unknown date and unknown if ongoing (she is a cancer patient on chemotherapy), fever blister from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced she had bell's palsy and she does not know if she got this from the covid shot or not but she still has the droopy lip which apparently that can last a while. on 02Feb2021, droop in her lip/mouth on 02Feb2021, her eye was still watering on 02Feb2021, there was a little puffing around the eye/ puffiness around her eye on 02Feb2021, double vision on an unspecified date, the way she talked she kind of had slurred speech on an unspecified date. Caller was calling about the Pfizer COVID 19 vaccine. She said on Friday 29Jan2021 she had the first shot at about 12:30. Her eye started watering in the morning Thursday the day before and she maybe assumed she was getting a cold in her eye but it was really runny and she got the shot. She was a cancer patient on chemo and she went to the doctor because she was supposed to get her chemo. That Tuesday morning she had a droopy lip on the right side and her eye was still watering, there was a little puffing around the eye and the way she talked she kind of had slurred speech so she thought stroke but she was going to get her chemo in an hour or 2 so she when they checked her she told them what happened, she was seeing the PA that day so she left and came back 10 minutes later and said she had talked to the doctor, they were not going to give chemo today and told her she had Bell's Palsy and she does not know if she got this from the COVID shot or not but she still has the droopy lip which apparently that can last a while. This was her first shot so as a cancer patient on chemo should be getting the second shot 21Feb. She was concerned about taking that when she already has Bell's Palsy now, what else would it cause and then if she does not get it would she be 50 % protected. The doctor seemed to say she thought it was from the vaccine, but caller does not know because the eye watering began the day or 2 prior to getting the vaccine. Product details: She does not have the vaccine card right with her and she was using a walker to get up and down and so she was not able to provide NDC lot expiration right now. It would be available if needed at a later time. Indication: doctor said she should have it because she has no immune system. They don't know what to do they are just following what they told her and they were scared to death. The caller states she was a cancer patient on chemotherapy. She received her first Pfizer COVID-19 injection on Friday, 29Jan2021. Prior to the vaccine, her eye had been watering Thursday or Friday morning before she had shot, it was just her right eye. On Tuesday, 02Feb2021, she developed a droop in her mouth and puffiness around her eye and so forth. Caller clarified it was just on the right side and with her right eye. She also has double vision in her right eye. She got up in the morning on 02Feb2021, and her husband was in the other room and told her that she sounded funny. She explained to her husband her mouth was dry and she was kind of slurring her speech. Her husband came into the room she was in and said, "huh, your lip was drooping". Since it was in the morning and she had no other symptoms besides the talking funny and the puffiness around her eye, she didn't take it as a stroke. She figured she would just until she went to her chemotherapy appointment she had the same day, 02Feb2021. She went into her appointment and showed the person and gave her information on what happened. The person wanted an MRI of the brain to make sure she didn't have cancer there or cancer anywhere else up in that area and also that she didn't have a stroke. She confirms the MRI was fine, both were negative for any signs of this. She was told she developed bell's palsy. She has a drooping lip. The caller was concerned about her second shot. She wants to know should she getting the second vaccine, because the person at the (institution name) office (where she receives her chemotherapy) believes the bell's palsy came from the COVID-19 vaccine. She was supposed to have chemotherapy that day (02Feb2021), but they wouldn't give it to her then, but she did have it done yesterday. Caller explains she has no NDC, Lot number or expiration date for the chemotherapy she receives. She isn't given any stuff with any numbers and she gets numerous medications. Patient's Medical History (including any illness at time of vaccination): Her eye was watering before the injection. She knows her eye was watering before she received the vaccine because as she was sitting waiting to receive her injection, she remembers wiping her eye and thinking to herself, "I wish this eye would quit watering". Caller states she had a fever blister, but she was not quite sure about when this appeared. She doesn't know if she had developed the fever blister before or the next day after receiving the vaccine, she was not quite sure. The any events were not required a visit to Emergency Room. She went to the Oncology Office for her chemotherapy appointment. No Prior Vaccinations (within 4 weeks). Caller had the MRI (magnetic resonance imaging) on 02Feb2021 showed she didn't have a stroke and no cancer of the brain. The patient underwent lab tests and procedures which included magnetic resonance imaging: negative on 02Feb2021 Negative for stroke and/or cancer. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.
78 2021-02-22 numbness approx 6:00pm, front of left leg from knee to ankle went numb. No pain , strange like it fell asleep... Read more
approx 6:00pm, front of left leg from knee to ankle went numb. No pain , strange like it fell asleep. After approx 24 hrs later started getting feeling back. Today, 2/23 back to normal.
78 2021-02-22 numbness At location, she felt fine during 15min wait At 3:30-4:30 Zoom call, she looked good, but said she w... Read more
At location, she felt fine during 15min wait At 3:30-4:30 Zoom call, she looked good, but said she wasn?t feeling great & was concerned due to chills & 4days headaches after 1st dose At 8:30pm she called with chills, 3 layers of clothes & bedwarmer on... said her teeth chattered & was trying to drink warm water to heat from the inside (hydration w/o cold water; said no more coffee) At 11:00pm she texted chills were over, she was expecting aches ?but would be asleep during them?... good attitude at the time At 2:19am she called, had fallen & couldn?t get up, said she called a friend to come help her ... said she?d tried to get up, but legs were numb... said she was dizzy when she fell, total dry mouth & had reached for water, but it spilled when she knocked into things when she fell. She wondered if she should call Fire Dept (but wasn?t making total sense). Her friend came, tried to help, but I think she decided to call 911 for help getting her up & wants EMTs to check her out. **She had fallen during Covid, went to ER & they gave fluids & she was ?good? for a week, but then dizzy & severe lethargy, same friend took her to ER & she was admitted (negative covid test at that point), but very large PE, thus heparin & then Eliquis (Dec 2020).
78 2021-02-22 numbness Waited 15 minutes after receiving the vaccine; went to car and when driving home about 30 minutes la... Read more
Waited 15 minutes after receiving the vaccine; went to car and when driving home about 30 minutes later my face and lips on the left side of my face went numb. The vaccine was placed in my left arm. The numbness lasted about 2 hours and then went away.
78 2021-02-23 muscle spasms Awakened by severe leg cramps in both legs, upper and lower, front and back. Pain so intense it? bro... Read more
Awakened by severe leg cramps in both legs, upper and lower, front and back. Pain so intense it? brought tears to my eyes and I woke my husband with my moaning. It lasted about 15-20 minutes. I have never had muscle cramping like this before or since.
78 2021-02-23 pain in extremity Next day after vaccination, I started getting sick. I wasn't holding anything down and this lasted 3... Read more
Next day after vaccination, I started getting sick. I wasn't holding anything down and this lasted 3 days and extremely sore arm
78 2021-02-24 burning sensation, pain in extremity Extreme pain and burning sensation in abdomen (Day 4-6), extreme pain (bone/joints/muscles) in left ... Read more
Extreme pain and burning sensation in abdomen (Day 4-6), extreme pain (bone/joints/muscles) in left arm (Day 6-8)
78 2021-02-24 feeling cold freezing to death; Chills; Fever; Headache; I was just really kind of blah, just didn't feel good at... Read more
freezing to death; Chills; Fever; Headache; I was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; I was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; I have mouth full of fever blisters; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on 06Feb2021 (at the age of 78-years-old) at single dose for COVID-19 vaccination. Medical history included blood pressure and heart disorder. Concomitant medications included metoprolol succinate (TOPROL XL) for heart medicine and hydrochlorothiazide/losartan potassium (LOSARTAN/HCTZ) for blood pressure. Historical vaccine included BNT162B2 for COVID-19 vaccination on an unknown date and had no problems with the first shot. On 06Feb2021, the patient experienced freezing to death; chills; fever; headache; was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; mouth full of fever blisters. Treatment for the events freezing to death, chills, headache, feeling bad, tired included acetaminophen (TYLENOL). The outcome of the events freezing to death, chills, headache, feeling bad, tired and mouth full of fever blisters was unknown. The outcome of the event fever was recovered in Feb2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
78 2021-02-24 pain in extremity I have osteoarthritis, with Heberden's nodes on all of my fingers. 3 days ago the two nodes on the... Read more
I have osteoarthritis, with Heberden's nodes on all of my fingers. 3 days ago the two nodes on the most affected finger (and the first that showed the arthritis) turned bright red. Now the whole joint is red and a few of the other nodes have turned red. Except for binding the first finger with the hope it would help (it didn't), I'm not treating them, since of course one can't do anything about osteoarthritis except ease the pain.
78 2021-02-24 pain in extremity Day 5 of Moderate to severe bilateral hand and wrist pain following Pfizer 1st COVID-19 injection 0n... Read more
Day 5 of Moderate to severe bilateral hand and wrist pain following Pfizer 1st COVID-19 injection 0n 02/21/21. Unable to prepare meals, wash dishes, do laundry or other daily chores. My son is typing this message for me. At this time I do not plan to get the second injection. Am sending this message to the CDC and Pfizer. Two 650MG Tylenol gives me little relief. I'm hopeful that someone might suggest something else.
78 2021-02-24 pain in extremity A couple of days after receiving 2nd shot my arm was a little sore and then began to itch. Then I go... Read more
A couple of days after receiving 2nd shot my arm was a little sore and then began to itch. Then I got a round red spot on my arm at the injection site. It continued to spread and get bigger
78 2021-02-25 pain in extremity sore arm; This is a spontaneous report from a contactable consumer. This consumer reported same even... Read more
sore arm; This is a spontaneous report from a contactable consumer. This consumer reported same event for different patients. This is the second of two reports. A 78-year-old female patient received COVID vaccine (trade name unspecified), via an unspecified route of administration at left arm on 19Jan2021 17:45 at single dose for COVID-19 immunization. The patient medical history was no, no other products, no investigation assessment. Family medical history relevant to event was none. No prior vaccinations within 4 weeks. Vaccination facility type was clinic. Vaccine was not administered at military facility. The patient's concomitant medications were none. The patient experienced sore arm after getting the shot on 19Jan2021. No visit to emergency room or physician office. Her husband asked about this being related to the change of life but she didn't think so. The outcome of the event was recovered on Jan2021 (Duration of reaction was also reported as -18 days). Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021102026 same drug, same event and different patient
78 2021-02-26 pain in extremity "Pfizer-BioNTech COVID-19 Vaccine EUA" My left arm/shoulder had pain shortly after the vaccination. ... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA" My left arm/shoulder had pain shortly after the vaccination. Tha pain has been there since day one (1). I have not been able to raise my arm above my shoulder level without pain. It has been difficult to perform a number of daily activities.
78 2021-02-26 pain in extremity 2/24 - Left arm very sore by 6:00 PM, took 500MG Tylenol. 2/25 - Arm still very sore, temp up 1 p... Read more
2/24 - Left arm very sore by 6:00 PM, took 500MG Tylenol. 2/25 - Arm still very sore, temp up 1 point above my normal, feeling very tired and achy, took 500 MG Tylenol at 12:30. Felt unwell all day. Took 650 MG Tylenol at 5:00PM and 11:00 PM. 2/26 - Arm is still moderately sore , but otherwise feeling better. 2/27 - Arm is still somewhat sore. With the 1st dose on 2/3, my arm was sore for 24 hours and I had no other symptoms.
78 2021-02-27 weakness Approx 4 hours after having the shot BOTH times; 1st time ache all over, bad headache; no appetite, ... Read more
Approx 4 hours after having the shot BOTH times; 1st time ache all over, bad headache; no appetite, very weak...stayed in bed for approx 30 hours 2nd dosage: approx 4 hours after shot; bad headache, no appetite, very weak lasted longer still in bed on following Sunday 2/28 (shot on 2/25) headache would come and go; was told to make sure someone stayed with me since I had had reaction with first shot and warned me thatif I had reaction to 1 would have for 2nd...No one to stay
78 2021-02-27 unresponsive to stimuli Death. Patient was found unresponsive in the morning hours after her shot.
78 2021-02-28 feeling of body temperature change lost 3 pounds; chills; Sheets were soaking wet, she kept having to urinate; Kept having to urinate; ... Read more
lost 3 pounds; chills; Sheets were soaking wet, she kept having to urinate; Kept having to urinate; Diarrhea; Getting very hot and cold; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: EL9262, via an unspecified route of administration on 07Jan2021 at a single dose in the upper part of left arm for COVID-19 immunization. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1686, expiry Mar2021, on 07Jan2021, she had no reaction or anything. The patient had no medical history. The patient's concomitant medications were not reported. The patient was calling about the second shot, Pfizer asked if there were side effects on the second one, and there were, she can't say what went on yesterday, it was that bad. She was a volunteer at the hospital. She lost 3 pounds in the last few days from this. She was in no condition to talk to anyone yesterday, and in fact, she was getting hot now. Yesterday (26Jan2021) was the worst, she doesn't know how to describe, but her sheets were soaking wet, she kept having to urinate, and she's ashamed, she almost couldn't make it to the bathroom, her aide said to not be ashamed, and she had a lot of diarrhea. It was around 2am she noted her sheets were soaking wet, and it started going away at 5AM. She was still having effects from the shot: she was still getting very hot and cold. Getting very hot and cold started 12:00PM Monday (25Jan2021) night. Getting hot and cold was like the chills. She has 27 chronic illnesses but doesn't think they have anything to do with the shot. She was grateful she got the shot and hopes everyone at Pfizer was able to get the shot. The outcome of the event 'sheets were soaking wet, she kept having to urinate' was recovered on 27Jan2021, diarrhea and getting very hot and cold was recovering, lost 3 pounds and chills was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
78 2021-02-28 flushing Immediate weakness in right arm, flushing of face and chest, minor shortness if breath
78 2021-02-28 muscle spasms she has a hearing problem; Constant chills; Cramps; Diarrhea; Nausea; This is a spontaneous report f... Read more
she has a hearing problem; Constant chills; Cramps; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration on 25Jan2021 10:30 on the left arm at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient stated that she did not experience any problems until 27Jan2021 around noon, in which she started experiencing chills, cramps, and diarrhea all afternoon. She would like to know if these reactions have been reported and if they continue to persist, can she take something like Imodium. She didn't have any effect at all from it on Monday or Tuesday, and at noon on 27Jan2021, she had nausea and constant chills and diarrhea, she doesn't think this was a side effect, but wanted to check and see. She was not terribly ill, just uncomfortable, is this something she should be reporting? Stated she has a hearing problem, wished for DSU agent to speak slower. Nausea: was off and on all the time since noon today, it is better, the main thing is diarrhea, and the nausea is connected Constant chills: improving, it came and went all afternoon, she doesn't know if it has gone away, she thinks it is still here, but she is not constantly bothered, it has been periodically since noon today. Diarrhea: better since she has nothing left; nothing was getting worse, she was reporting it because she thought it may be a side effect. Outcome of the events constant chills and nausea was recovering, diarrhea was recovered on an unspecified date while unknown for the other events.
78 2021-02-28 pain in extremity I have a temp of 100; feel tired; arm is really sore; achy; This is a spontaneous report from a cont... Read more
I have a temp of 100; feel tired; arm is really sore; achy; This is a spontaneous report from a contactable consumer, reporting for herself. A 78-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Jan2021 at 14:45 (at the age of 78 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included restless legs, high blood pressure, and prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 27Jan2021 at 08:00, the patient experienced temperature of 100, feels tired and achy plus the arm is really sore. The patient did not receive treatment for the events. The clinical outcome of temperature of 100, feels tired and achy plus the arm is really sore was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
78 2021-03-02 weakness, pain in extremity felt fairly decent/feel bad; she "came down with covid"/test positive for COVID; she is kind of weak... Read more
felt fairly decent/feel bad; she "came down with covid"/test positive for COVID; she is kind of weak; her heart was racing; aching/aches; she ran a fever that got up to 101; cough; her arm got sore; allergies; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) on 15Jan2021 at single dose in left arm for COVID Prevention. Medical history included ongoing High Blood Pressure, she was diagnosed approximately 5 years prior to starting blood pressure medications in 1998. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN AND HYDROCHLOROTHIAZIDE) at 320mg/12.5mg, once daily, by mouth from 1998 and ongoing, amlodipine besylate at 5mg, once daily, by mouth at night from 1998, both for High blood pressure. The patient stated that she did not realize, but she must have been exposed to the COVID Virus, prior to getting her shot. She stated that on 15Jan2021, she went and got her Pfizer COVID shot, and that same day, by the time she got home, she was starting to feel bad and it went downhill from there. She mentioned that on the same day on 15Jan2021, she "came down with covid". She finally went in on 22Jan2021, and got tested, and she did test positive for COVID. The patient was tested Positive for COVID-19 on 22Jan2021. She did believe she was getting better. On 29Jan2021, she felt fairly decent, and today, she is kind of weak but she is assuming that will happen. She was scheduled to go back for her second dose on 08Feb2021, and she is wondering if there are recommendations about the second dose, for people who tested positive for COVID after having gotten the first dose. When queried for her PCP contact information, she stated that her head is not working really great and she feels stupid she did not have this information handy to provide. She states that the first week with her symptoms, she just figured she did have the virus. She had a cough but it never got down to where she had trouble breathing, and she just figured that her body had to go through, whatever it was going to go through, and as long as the patient felt like she was okay, there was not anything anyone could do, she just had to play it out. When she did finally go get tested, the doctor told her to get on Nyquil and Ibuprofen, so that is what the patient has been taking, and she feels like it has helped a lot. Before she saw the doctor, she was taking Acetaminophen, but the doctor told her to do the Nyquil and Ibuprofen, so that is what she has been doing. By the time she got home from getting her vaccine, her heart was racing. She took her blood pressure and it was okay at 125/73, and her heart rate was 72. She has high blood pressure and she takes two medications for that, so she took her night time blood pressure pill and the fast beating of her heart went away. The next day, she got to aching. She has had all different aches, and she ran a fever that got up to 101, and the rest of the time it was 100 or 99, but the fevers were not all day long, they would just come and go. Now she has had no fever in four or more days, and she is doing better. She does still have the cough, but she also has allergies so she does not know what is causing the cough. As far as the reaction to the vaccine, just her arm got sore. But she thinks she was exposed prior to getting the vaccine and just did not know it. she stated that the people took her temperature the day of the shot and she didn't have a temperature. She did not receive any other vaccines on the same day as the COVID vaccine. The outcome of fever was recovering, of cough and allergies was not recovered, of her heart was racing was recovered.
78 2021-03-02 weakness Weak and fatigue. Not wanting to eat or drink. Unable to walk without holding onto items. Sleepy, bu... Read more
Weak and fatigue. Not wanting to eat or drink. Unable to walk without holding onto items. Sleepy, but unable to sleep. Nine days after 2nd shot still having the same symptoms.
78 2021-03-02 tingling, numbness Numbness and tingling in the left hand finger. Initial BP 172/63, pulse 71, 99% O2 sat. Patient went... Read more
Numbness and tingling in the left hand finger. Initial BP 172/63, pulse 71, 99% O2 sat. Patient went to the ED.
78 2021-03-04 pain in extremity pain in left leg/side. report unable to walk up/down stairs
78 2021-03-04 tremor Excessive shivering/shaking; weakening of lower legs; spiked high temp during the night into the n... Read more
Excessive shivering/shaking; weakening of lower legs; spiked high temp during the night into the next day. 102, finally lowered 48 hours later. Nausea; massive headache; complete body pain in muscles and joints, including jaws and eye sockets. exhaustion, fast hearbeat; no injection site swelling or pain. Reecovery within 72 hours, fatigue and nausea for another 12 hours more or less. I do feel it was worth it.
78 2021-03-05 feeling cold Fatigue,Nausea, headache, chills for 26 hours
78 2021-03-05 speech disorder Guillian Barre reaction (difficulty walking, difficultyusing hands- small motor skills; difficulty s... Read more
Guillian Barre reaction (difficulty walking, difficultyusing hands- small motor skills; difficulty speaking; began on 2/7/21 and continued to worsen until hospitalization on 2/24/21 and 5 plasmapheresis treatments. While hospitalized patient has developed double vision.
78 2021-03-07 numbness Client verbalized numbness to left arm after receiving the vaccine. Client was assessed by Rescue P... Read more
Client verbalized numbness to left arm after receiving the vaccine. Client was assessed by Rescue Paramedics. According to client "I feel better." patient was released to go home at 9:45 am after symptom was resolved. Per Paramedic no further evaluation needed.
78 2021-03-07 pain in extremity Right arm was sore for four days , and has had a headache since 3/5. Sometimes the headaches were se... Read more
Right arm was sore for four days , and has had a headache since 3/5. Sometimes the headaches were sever and it has been mild in between.
78 2021-03-07 tremor, seizure Chills day Feb 6, Sick feeling & worse tremors Feb 7-Mar 1, Multiple Seizures Feb `13, & F22. Extre... Read more
Chills day Feb 6, Sick feeling & worse tremors Feb 7-Mar 1, Multiple Seizures Feb `13, & F22. Extreme sporadic stuttering started Feb 20 and continues till today Mar mad 2nd shot March 1st. Had multiple seizures Mar 13 preceded by stuttering. Had 3 extreme whole body seizures Mar 7, Today Mar 8.
78 2021-03-10 bell's palsy Bells Palsey, currently impacted, recovering, prednisone, valacyclovir
78 2021-03-10 burning sensation At Midnight 24 hours later I felt a burning sensation in both legs. I did not have a fever. The burn... Read more
At Midnight 24 hours later I felt a burning sensation in both legs. I did not have a fever. The burning sensation lasted 1 hour.
78 2021-03-13 burning sensation Facial itching then burning (no redness or swelling)
78 2021-03-13 pain in extremity I was vaccinated with Pfizer for the first time 11 days ago. Within a few minutes of being vaccinate... Read more
I was vaccinated with Pfizer for the first time 11 days ago. Within a few minutes of being vaccinated, I felt nauseated but I did NOT throw up. I have been sick ever since with one thing and another. For the first several days after being vaccinated, I had a sore arm, which I expected. I have also experienced extreme fatigue, chills, nausea, muscle and joint aches, a sore throat (briefly), an occasional headache, tenderness in my left armpit and along the left side of my rib cage, stomach pain and diarrhea and at times, a low-grade fever and sweating. My memory and ability to focus on my work have been affected. Yesterday (March 13), I felt OK all day and thought I was better at last, but after I ate dinner, I vomited and had diarrhea. I told my primary care physician about all of this in an email and she replied that my symptoms were "normal." I'm not so sure. I haven't read of anyone else feeling so sick for so long after the first dose of Pfizer.
78 2021-03-14 numbness Numbness in calves, pain in calf muscles, varying from slight to severe; slight numbness on occasi... Read more
Numbness in calves, pain in calf muscles, varying from slight to severe; slight numbness on occasion in arms and mouth area. This has not gone away. It is not debilitating. I had the same reaction to a flu shot several years ago. This lasted about 1 1/2 years, then slowly went away.
78 2021-03-14 pain in extremity Patient called stating four days after shot, started to have pain in arm and was black and blue. Had... Read more
Patient called stating four days after shot, started to have pain in arm and was black and blue. Had been taking pain relievers and ice pack around the clock. Referred patient to PCP for follow - up and to continue until seen.
78 2021-03-14 pain in extremity Pain in left leg - outside 2/7/21 went to clinic 2/8/21 Given an ultrasound Diagnosis: Blood Clot (D... Read more
Pain in left leg - outside 2/7/21 went to clinic 2/8/21 Given an ultrasound Diagnosis: Blood Clot (Dvt) Given immediate shot in belly And prescription for Eliquis Followed up with Dr. (internist) 2/11/21
78 2021-03-14 pain in extremity No discomfort in arm for 2 weeks after vaccination. Full pain in most of left arm
78 2021-03-15 weakness 03/13/2021: Presented to the emergency department for fever, generalized weakness, nausea, and vomit... Read more
03/13/2021: Presented to the emergency department for fever, generalized weakness, nausea, and vomiting. The patient was admitted for GI evaluation who stated that the nausea, vomiting, and chronic diarrhea, could be from gastroparesis and diabetic diarrhea versus IBS. The patient was discharged the next day with outpatient follow up with her primary gastroenterologist.
78 2021-03-15 muscle spasms muscle cramping in the right calf; This is a spontaneous report from a contactable consumer (Patient... Read more
muscle cramping in the right calf; This is a spontaneous report from a contactable consumer (Patient's husband). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no: EL3246), on Left Arm via an unspecified route of administration on 30Jan2021 9:15 AM at single dose for covid-19 immunisation. The patient medical history was not reported. The patients concomitant medication included unspecified Vitamins since 50 year. It was reported that Patient experiencing muscle cramping in the right calf, began 30Jan2021 9:15am, cramping started that afternoon. 6 hours later or so. Patient questioned was this a normal side effect. Just feels different. The Fax sheet he received stating the indication was to administer the vaccine as 2 doses, 3 weeks apart. However, the card he received at vaccination center had both him and his wife scheduled 27Feb2021 which was 4 weeks. He also had to report a side effect for his wife. His wife got her vaccine on the left arm, but right leg calf muscle was constantly acting like a Charlie Horse, it's cramping, like the muscle was pulling in the right calf. His Wife's first dose was on 30Jan2021 at 9:15 AM, and in the afternoon on the same day was when right calf cramping started, since then it has been constant. The Right Calf Cramping was definitely the same. He did not know if it was worse or not but she was just complaining last night about it, it's continuing, it has caused her to wake up during the night. for both him and his wife the second dose may be schedule on 27Feb2021. He clarifies that he was not sure what his wife was told, but the young woman gave the same date on his card and said this was the earliest date that he can be scheduled. Outcome of the event was not recovered
78 2021-03-18 pain in extremity, numbness left arm aching from the site of the injection; aching from back of her arm to the back part of her ... Read more
left arm aching from the site of the injection; aching from back of her arm to the back part of her elbow, then it comes to the far outer part of her forearm down to the wrist and ring finger and pinky finger.; numbness down left arm/partially numb, she has feeling because it's aching; itchy torso from armpits to hips/itchy back and stomach; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6201), intramuscular, administered in left arm on 23Feb2021, 14:00 as single dose for COVID-19 immunisation. Medical history included neuropathy in feet, cholesterol (abnormal), 2 vertebra in her back that are starting to fuse, shrinking as she's getting older, allergic to NSAIDS, she clarifies Advil, Tylenol and the medications reverses on her and gives her a headache, and she gets itchy; was in the hospital for surgery, for lady stuff and needs glasses. She doesn't have a heart problem she doesn't have any other medical issues. She's not diabetic the neuropathy was idiopathic. Concomitant medications included atorvastatin for cholesterol (abnormal), acetylsalicylic acid (BABY ASPIRIN), and duloxetine hydrochloride (CYMBALTA). The patient previously took morphine and was allergic, and hallucinating as she was told by the nurse, she said there were monkeys on the ceiling and her husband was trying to kill her and gets itchy with morphine. This is the same reaction she had when found out she had the reaction to NSAIDs, for example, she could take Advil or Tylenol for one night but it she took it two nights, that was when she woke up itching all over. She reports no rash, just itch. It just lasted that one night and it was gone. She could take some Advil and get that itchy feeling. On 01Mar2021, the patient experienced left arm aching from the site of the injection back down under the back of her arm to the back part of her elbow, then it comes to the far outer part of her forearm down to the wrist and ring finger and pinky finger; numbness down left arm/it was also partially numb, she has feeling because it's aching and she was describing it as an ache, not sharp just an ache. She can feel it, but its not all there. She knows all this stuff was new to all of us. She's following up and doesn't keep her up at night it's just not normal; and on 24Feb2021, her torso, the night after injection, from her armpits to her hips was itchy. She woke up and she went to the bathroom scratching her back and stomach. Her Covid 19 vaccine card was handwritten she sees 23Feb2021 and that's the date she got the shot. She's been isolating since Feb2020. She was only going out for necessity. She took a risk and had family at her home for Christmas. She hasn't been to church in almost a year, so she was taking this very seriously. Before they even started telling you to wear a mask she was listening to the news in December and January. She states, alright she's isolating, it's the safest thing she can do she's not ready to leave this world yet even knowing she's past her golden years. Her doctor put her on Atorvastatin it because of her age, she had blood drawn but she wasn't given any counts on an unspecified date. Her first thought was she had a chest problem but it's not a heart attack, the ache doesn't go any farther than what she told. It's not stopping her from being productive, from doing things. The events did not require a visit to the emergency room, physician office and was not hospitalized. The patient had no prior vaccinations within 4 weeks and no events following prior vaccinations. Outcome of event itchy torso from armpits to hips/itchy back and stomach was unknown; and outcome of the rest of events was not recovered.
78 2021-03-20 pain in extremity Lightheadedness; tired; aches in her hands; corner of her eye and around it was itching really bad; ... Read more
Lightheadedness; tired; aches in her hands; corner of her eye and around it was itching really bad; started hurting and felt strained; started itching in her body; Headache; muscle aches; Nausea; Chills; This is spontaneous report from a 78-Year-old Female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9269), via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunization on arm left. The patient relevant medical history and concurrent conditions included cataracts from 2005 with ongoing, macular degeneration from 2012 with ongoing, arthritis from an unknown date and ongoing and fingers and both hands that had knots since 2010. The patient stated that she had nausea, chills, headache, and muscle aches on 02Feb2021, and on 03Feb2021, she had lightheadedness, tired, and aches in her hands where she has arthritis and all at once that the corner of her eye and around it was itching really bad and she touched it to relieve the itch and they started hurting and felt strained. The patient got Systane over the counter eye drops that she had and held hot compresses to it. She reported that it lasted for a few hours and she had cataracts and a little macular. The patient started itching in her body at 7:30 and took Benadryl and went to bed and it went away. She was concerned with second vaccine as she got through the nausea and everything else, but her eyes scared her. The patient received treatment medication for nausea and took Tylenol for Arthritis and muscle aches. The patient had an x-ray 3 years ago for her back and was diagnosed for unknown results. The outcome of the events nausea, aches in her hands, corner of her eye and around it was itching really bad, started hurting and felt strained and started itching in her body was resolved on 03feb2020, whereas the events chills, lightheadedness, tired, headache and muscle aches were resolved on 04Feb2021.
78 2021-03-21 weakness I had the second Covid (Pfizer) vaccine on February 22. The next day I had chills, fever, aches, nau... Read more
I had the second Covid (Pfizer) vaccine on February 22. The next day I had chills, fever, aches, nausea and was very weak. After about 30 hours I felt okay again. However, a week and a half later, I noticed red bumps on the back of my neck. The next day, my neck and scalp had red, itchy blotches. Through the next five days, these spread down my body to my ankles until I was covered with the red, very itchy blotches. I did go to Urgent Care on the third day and I was given a 5-day prescription of Prednisone. It did not do much until the third day and then it relieved the itching somewhat for about 6 hours, but then it would start again. After the five days of Prednisone, I took Benedryl for three days until the itch and redness disappeared. I checked the facility web site on types of rashes and my rash fits the description (and the photo) of a drug-related rash, but I have not changed or added any drugs for several years other than the Covid vaccine (I did some research online and found two other people who have had the same problems I have had after the second Covid vaccine. Both of them had the typical reaction of chills, fever, aches and dizziness for about a day after the second shot and then 1-2 weeks later, broke out in a rash. Both reported having the rash start at the neck or head and then spreading down the body throughout one to two weeks before disappearing. There were photos on the facility site of drug-related rashes and they were exactly like what I had. Since the rash was almost certainly covid vaccine related, I am making this report, which my doctor recommended. I had no other changes in diet, medications, environment, etc. ? only the Pfizer vaccine was new to my body.
78 2021-03-21 feeling hot Feeling hot, dizzy, blurred vision
78 2021-03-22 weakness vaccinated 1/13. presented for COVID screening on 1/14 due to a + exposure. Test was +. Patient c... Read more
vaccinated 1/13. presented for COVID screening on 1/14 due to a + exposure. Test was +. Patient came to ED on 1/16 with weakness, congestion, poor appetite, coughing. Previous headache and sweating had resolved by the time she presented. Discharged with isolation instructions. Returned to ED late on 1/22 with " right-sided chest pain described as sharp constant 6/10 nonradiating pain localized to the right side of upper chest, shortness of breath with exertion since this afternoon. She does endorse subjective fevers, with associated increased coughing which is productive in nature, shortness of breath." Admitted to ICU early 1/23, transferred to Medical Center on 2/4/21.
78 2021-03-24 depressed level of consciousness, migraine Severe migraine headache and multiple joint pain until steroids Mar 21, now slight headach. Swollen ... Read more
Severe migraine headache and multiple joint pain until steroids Mar 21, now slight headach. Swollen face Mar 20, 21, 22. Fatigue and brain fog for 10 days. Went to emergency room twice. Mar 18 and 21.
78 2021-03-24 pain in extremity I just started coughing and they told me to go to the emergency room so I did you know; arm got real... Read more
I just started coughing and they told me to go to the emergency room so I did you know; arm got real sore; Fever; feel nauseous; Dizziness; got progressively worse; I could hardly do over I was just so sick with the dizziness; Dizziness; got progressively worse; I could hardly do over I was just so sick with the dizziness; I have been so off-center; This is a spontaneous report received from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, second dose on 10mar2021 (formulation: Solution for injection, lot number: EIV6202) via an unspecified route of administration at single dose for covid 19 immunisation. The patient medical history included ongoing tubular dysfunction, migraine and patient had the vestibular Dysfunction from 40 years, ongoing migraine headache. The patient historical vaccine included BNT162B2 (formulation: Solution for injection, lot number: EL9267), (first dose) via an unspecified route of administration on 17feb2021 at single dose for covid 19 immunisation and took Flu shot for immunization. The patient had regular flu shot a few years ago it was mentioned that doctor told get a Benadryl an hour before my shot which I did and she was in the hospital for 5 hours on a Breathing machine. Concomitant medications included rizatriptan benzoate (MAXALT) at 10 mg, as needed for migraine. Consumer stated, "I had Tubular Dysfunction been diagnosed many years ago and I live with dizzy every day In Mar2021. I have tried everything to get rid of it and nothing is working. This is going on for Probably 40 years may be more anyway (Intent: History). I had my second vaccine on 10Mar2021 and on the first day, my doctor told me since I had the reaction to the regular Flu shot a few years ago my doctor told me get a Benadryl an hour before my shot which I did and the first day everything was wonderful. I was so happy you know no reaction, I didn't have any. The first time I got the flu shot I was in the hospital for 5 hours on a Breathing machine, it was beautiful. I thought I was free and then the next day my arm got real sore and I expected that and I expected to have a fever I expected to feel nauseous and all but the dizziness set in and just got progressively worse and it will be a week tomorrow since the vaccine still I was dizzy In Mar2021. I have been so off-center In Mar2021. Sunday I could hardly do over I was just so sick with the dizziness and yesterday the same thing and this morning I thought I will get over maybe today will be a good day and it's the same. I called my neurologist and he said that any pre-existing condition can be exaggerated by the vaccine while the system is building up his anti-bodies so I expected but is this going to go away, this thing, is this going to go away and reported just so beside myself, I just can't live like this anymore everyday you know this is beyond dizzy." tried taking, I do have a prescription for it starts with M wait a minute it hasn't helped but I tried it , if it doesn't help for the first time I won't take it again but I have a prescription for Meclizine 25 mg Tablets. Consumer stated, "I spoke to somebody earlier and told me to call this number and tell you that what's going with me. Tomorrow will be one week, since I had my second Covid shot and the first day, I got it everything was fine. The second day I was feeling a little off and I thought okay will they told me that I would feel little, may be not sick-sick but not feeling good and then the second day after that Friday. I got it on Wednesday and by Friday, I have a pre-existing condition and it is called Vestibular Dysfunction. Consumer stated, "I had the Vestibular Dysfunction from 40 years. So, I live with dizzy all the time. But by Friday, it is just unbelievable dizzy, Saturday was worse, Sunday was even worse, yesterday was little bit better. Today, I am still shaking and dizzy and Tomorrow will be one week since I have the shot and I read that stuff happened in the first week and I was wondering, have you had the other people with the same problem, Consumer further added, "It is not an inconvenience, this is horrible way to live. I feel dizzy all the time, this is horrible. Was I told that I should talk to you about, can the shot exacerbate a bad situation like this, they told me to call you, now I getting no help at all can anybody tell me." Consumer stated, "Nothing I have no recollection of any of that no, I just started coughing and they told me to go to the emergency room so I did you know In Mar2021. The patient has received treatment with Meclizine 25 mg tablets. The outcome of the events was reported as unknown.
78 2021-03-24 unresponsive to stimuli Resident found unresponsive found at 1545, CPR done, EMS responded and resident Pronounced Dead at 1... Read more
Resident found unresponsive found at 1545, CPR done, EMS responded and resident Pronounced Dead at 1615
78 2021-03-25 weakness, tingling she woke up dizzy; it was like everything was moving or shaking just a little bit, and it would driv... Read more
she woke up dizzy; it was like everything was moving or shaking just a little bit, and it would drive someone crazy; her eyes felt like they were burning out of the sockets; she was tired the next morning; she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet; she was nauseated; temperature of 103; she broke out in a terrible sweat; she was weak as water; light headedness; high blood pressure; This is a spontaneous report from a contactable consumer via Medical information centre. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 27Jan2021 14:00 as single dose for covid-19 immunisation. Medical history and concomitant medications was not reported. On 27Jan2021 20:00 the patient experienced light headedness, she broke out in a terrible sweat, she was weak as water. On 27Jan2021 the patient experienced high blood pressure. On 28Jan2021 her eyes felt like they were burning out of the sockets, she was tired the next morning, she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet, she was nauseated, temperature of 103 (pyrexia). On 05Feb2021 she woke up dizzy and it was like everything was moving or shaking just a little bit, and it would drive someone crazy. The event high blood pressure was considered as serious (Medical significant). It was reported that she had the Pfizer COVID shot 2 weeks ago today. She had severe reaction to the shot, she didn't have it immediately she got the shot on 27Jan2021 and at 2 pm and at about 8 pm she was sweeping the floor and she broke out in a terrible sweat and after that she was weak as water and then started feeling lightheaded and her blood pressure was going up, she put cold rags on her head. She did not take temperature but she did take her blood pressure and it was like 198/something, she said she noted at 8:30 she took it again and it was 180/98 she started drinking water she thought she might be dehydrated and finally by 9:45 she got it down 148/58, she slept that night felt pretty good but she was tired the next morning, about 4 o'clock that afternoon the second day she felt wonderful she went to sleep at about 10 o'clock, but when the clock was striking midnight it woke her up and she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet she was lightheaded her eyes felt like they were burning out of the sockets, she was nauseated when she stood up so she took Tums and that took care of the nausea. She came in and took her blood pressure and that is when it was 194/90 the second time, she has a Rely On arm band and it said 205/98 and then she took it again and it said 235/117. She called the medic and he told her he thought she had a false reading but her temperature was 103 and before he left her blood pressure come down 180/70. Her heart rate was 86 the medic got ready to go her temperature came down to 102.2. On 05Feb2021 which was last Friday she woke up dizzy and light headed and but it was like everything was moving or shaking just a little bit, and it would drive someone crazy .On Saturday she took 3 Motrin that morning and Amlodipine 5 mg and 20 gm Omeprazole and she also takes 1 24 HR Allegra with Fexafenadine and her temperature was normal that day, all day it has been normal. On Sunday at lunch time she got light headed and was floating again and she checked her blood pressure and it was 183/77.She stated that her doctor recommended to get the second dose if she have no more side effects She plan on getting the second dose next Wednesday. Therapeutic measures were taken as a result of high blood pressure, she was nauseated and temperature of 103. The outcome of the events was unknown.
78 2021-03-25 weakness Pt received vaccine and waited 30 minutes post-vaccination due to list of allergies/intolerances to ... Read more
Pt received vaccine and waited 30 minutes post-vaccination due to list of allergies/intolerances to medications/vaccines. After leaving vaccine clinic, Pt developed weakness and dizziness and returned to COVID Vaccination Clinic to report symptoms. Vitals signs taken: 238/101 HR 87BPM, O2 97%; Emergency Responders called to transport Pt to ER for evaluation; BP 217/100 on recheck.
78 2021-03-27 pain in extremity, numbness The injection was given high up on my arm and was very painful. About an hour after receiving the s... Read more
The injection was given high up on my arm and was very painful. About an hour after receiving the shot my arm felt weak and my hand and fingers felt numb. I could not raise my arm. This lasted into the next day, when my shoulder began to hurt. The feeling returned to my hand but I started getting drawing pains in my arm, and increasing pain in my arm when raising it.
78 2021-03-28 bell's palsy, facial paralysis patient has drooping/paralysis on right side of the face presenting that it looks like temporary Bel... Read more
patient has drooping/paralysis on right side of the face presenting that it looks like temporary Bells Palsy
78 2021-03-28 migraine, weakness Migraine 10 hours? Headache and foggy head on and off for four weeks? Muscle pain and weakness upper... Read more
Migraine 10 hours? Headache and foggy head on and off for four weeks? Muscle pain and weakness upper arms, thighs to pelvis, sometimes buttox Most difficulties with muscles are during the night and upon arising in a.m. At least four days I was unable to function. Tylenol helped for short periods.
78 2021-03-28 pain in extremity 03/23/2021: Patient presented and was admitted through ED for right lower extremity pain after a rec... Read more
03/23/2021: Patient presented and was admitted through ED for right lower extremity pain after a recent fall. CT of the pelvis which showed to have Comminuted subtrochanteric proximal right femoral shaft fracture with angulation. She had difficulty walking, and difficulty with activities of daily living skills. Patient had PMH of arthritis. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
78 2021-03-29 pain in extremity Moderate to severe bilateral wrist pain; Moderate to severe bilateral hand pain; This is a spontaneo... Read more
Moderate to severe bilateral wrist pain; Moderate to severe bilateral hand pain; This is a spontaneous report from a contactable 78-year-old female consumer reported for herself that: A 78-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198),dose 1 intramuscular, administered in Arm Left on 20Feb2021 13:00 as SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced moderate to severe bilateral wrist pain on 21Feb2021 15:00 and, moderate to severe bilateral hand pain on 21Feb2021 15:00 and Day 5 of Moderate to severe bilateral hand and wrist pain following Pfizer 1st COVID-19 injection 0n 21Feb2021. Unable to prepare meals, wash dishes, do laundry or other daily chores. My son is typing this message for me. At this time I do not plan to get the second injection. Am sending this message to the CDC and Pfizer. Two 650MG Tylenol gives me little relief. I'm hopeful that someone might suggest something else. and outcome of the event was not recovered.
78 2021-03-30 weakness, pain in extremity cannot take good deep breaths because of the soreness in her ribs; soreness in her ribs; She had no ... Read more
cannot take good deep breaths because of the soreness in her ribs; soreness in her ribs; She had no urge to eat/Has no desire to eat or drink; lost 10 lbs; feel ill; General feeling of the flu; had a slight sore arm; nausea; severe pain, her hip and knee were killing her; was having major problems, a delayed immune response; Rash covering her entire body; acute pain and with deep breaths; low grade fever; cough/Cough was a dry, tight, non-productive cough; Weakness; Chronically dehydrated; the COVID Vaccine wasn't working; the COVID Vaccine wasn't working; This is a spontaneous report from a contactable nurse. This nurse (patient) reported that a 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6204) at the age of 78-years, via an unspecified route of administration on 04Mar2021 at single dose; first single dose of BNT162B2 (lot: EM9810) on 11Feb2021; both for COVID-19 immunisation. Medical history included osteoarthritis (having aches and pains) had for 20 years; large sliding hiatal hernia was diagnosed from an EGD six months before, didn't want surgery to fix it; heartburn (last five years); fatty liver, was not from drinking alcohol; generalized anxiety; was tuberculosis positive only because she was exposed years ago. Concomitant medications included pantoprazole started four to five years before at 40 mg twice a day for heartburn; escitalopram (tablet) been on for 15 years or longer at 10 mg 1 DF every day for generalized anxiety; clonazepam 0.5 mg nightly at bedtime for anxiety (been taking for last ten years or more, stops her from worrying about her kids and stuff like that). The patient experienced on 07Mar2021, low grade fever, weakness, chronically dehydrated and cough; on 15Mar2021, rash, acute pain and with deep breaths; on an unspecified date, no desire to eat or drink. Seriousness criteria of these events were reported as disabling. Patient reported that was having major problems, a delayed immune response. Told everybody if this keeps up she was not going to make it. It was wearing her down and she was not going to survive. Occurred after second COVID vaccine. She is active, goes to pool, and does different things. Had vaccine on Thursday and was ok until Sunday. Started Sunday with low grade fever. Kept being low grade and never got to 101, 102, or 103. She didn't take ibuprofen. Usually takes ibuprofen once a day for routine aches and pains. Having weakness. Had no desire to eat or drink. She waited a couple days, but then called her doctor. Doctor's office wouldn't give her an appointment. Stated this wasn't the routine and has been going on for 10 days. This was too much. Two days later, caller's daughter-in-law took her to a place like an ER. A bunch of tests were done. She asked for an IV because she was chronically dehydrated. Weakness was getting to her. After seeing the doctor in the mini surgical ER, she didn't feel any better. She felt the same. Same nausea, weakness, low grade fever, the whole thing. Decided to see her regular doctor. Stated it wasn't her chest. Wanted to be told what was going on. Her regular doctor didn't order any labs. She was given a steroid shot. Thought she was in deep doo-doo. Stated this was not a good sign and she was not going to make it. She woke up yesterday with a rash covering her entire body. She had no clue she had the rash. Never saw the rash. Rash didn't itch, but she still had it. After steroid shot from doctor, she felt a little bit stronger and thought maybe she was going to make it, but then started getting severe pain. Patient was used to having aches and pains that went along with old age and her osteoarthritis. This was severe pain as if she fell and hurt her ribs. It hurts to take deep breaths. Her hip and knee were killing her. It was acute pain, not normal pain. This morning stated she couldn't take it and was going to take ibuprofen, which was not the best for her. She didn't want to eat, but tried to have food in her stomach to take the ibuprofen. She cannot take good deep breaths because of the soreness in her ribs. Thought something in her body was having a delayed immune response and her gut told her it was not good. For low grade fever, did not take ibuprofen, 07Mar2021 was when she started feeling yucky, she wanted to see how she felt and her temperature never really got up, stuck it out, normal temperature for her was 97 or lower, her temperature once in a while would range from 98 to 100.3 or 100.8, she cannot take paracetamol (TYLENOL). For weakness, noticed right away, felt a little better after steroid, had not been out of her door except to the ER. For chronically dehydrated, clarified she had no desire to eat, usually drinks coffee and tea in the morning, but now had no desire, was making herself drink, felt something wasn't right beginning on 07Mar2021, everything went south and got worse, clarified it really wasn't nausea, but no desire to eat or drink, doctor today gave her ondansetron (4mg) which didn't help and made it worse, eating and drinking didn't make her sick, just didn't want it. She had labs done in the ER and was told her labs weren't really that off for her to be that dehydrated. Asked for an IV because she was not drinking what she normally drinks, didn't feel any better after the IV. Rash covering her whole body, but didn't itch. Acute pain and with deep breaths began evening of 15Mar2021, seemed the same today, she just took an ibuprofen a little while ago and was feeling better. Patient also mentioned that realized her body was trying to get monoclonal antibodies and resistance to build up her immunity so that if she ever got infected with COVID virus she could fight it, it was just not working, it was not doing its thing, she was having a delayed immune response, was very worried about that, going on 8-9 days and it was weakening her by the day, didn't think she could take this too much longer. Clarified the COVID Vaccine wasn't working and her body couldn't get its act together. Patient had a slight sore arm after the second dose, never reacted at the injection sight, it was strictly internal, which kind of scares her, something was not right, was having the rash, pain, and severe weakness. Was not expecting any kind of problem. Didn't think too much about the second COVID Vaccine. Stated people were like "oh that second shot." If she didn't get better soon she is not going to do well. Cough was a dry, tight, non-productive cough, lungs were checked yesterday and were clear, felt like all of a sudden she has an urge to cough and nothing comes up. For steroid shot, didn't know if it was dexamethasone (DECADRON) or not, made her feel a little stronger for the day, but then brought on severe aches and pains in her joints and ribs, did not have this until the steroid shot. Patient said that didn't take ibuprofen the first couple days because she didn't want to mess up the immune response starting in her body, asked doctor about immune globulin for her delayed immune response, but doctor shook his head, knew that people with autoimmune are ordered IGE or IGG to test the immune system, asked doctor about this, but he shook his head. Stated she didn't think a CBC with different was performed at the ER, confirmed she was only in the ER after the second dose and was not admitted to the hospital. As of 17Mar2021, she stated then two to three days after that she woke up with rash over her entire body that showed up overnight, that alarmed her even more of course, no itch or nothing, no clue it was there until she washed off and could see it, she had never had a rash before, her arm never got red, but she had a low grade fever, stated now didn't know if good or bad, cough, not productive, some urge to cough, no appetite, not eating or drinking, and increasing weakness, today she couldn't say anything was different about her rash maybe slightly faded but she didn't feel any better, she did get a steroid shot when she went to doctor yesterday and that made her feel less weak. As of 18Mar2021, patient stated that had no reactions for the 1st 2 days following her 2nd dose however she started to feel ill, low grade fever that never went above 100. General feeling of the flu; aches and pain, which she had before but more than usual. She had no urge to eat. Tried to see her doctor when it had been going on for 5 days but they were not concerned. By that Friday, she went to the hospital. They found nothing wrong in her lab tests but she asked them for I.V fluids since she hadn't eaten or drank anything. On Monday, she went back to her initial doctor because she had a rash all over her body, it did not itch and her injection site had no redness. She was given a steroid shot, today she might be feeling a bit better. She lost 10 lbs. She had to stay inside for the past 10 days, except for doctor visits, although she was usually an active person. She would like to know how long the side effects would last. Outcome of the events low grade fever/ wasn't working, weakness, rash and acute pain and with deep breaths, cannot take good deep breaths and soreness in her ribs was not recovered/not resolved while of remain was unknown. Relatedness per primary source reporter via global introspection of BNT162B2 to events low grade fever, weakness, chronically dehydrated, no desire to eat or drink, acute pain and with deep breaths and cough were related.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
78 2021-03-30 pain in extremity, weakness, feeling cold, flushing her immune system since has not been the same and has been very deprived; her immune system since ha... Read more
her immune system since has not been the same and has been very deprived; her immune system since has not been the same and has been very deprived; wasn't feeling right; Dizzy; weak and very disoriented; weak and very disoriented; did not feel good; terrible headache and laid down right away; things started spinning/head spinning; Nauseous; Flu like symptoms; Flushed; very cold; chills; very cold; chills; Pain in arm; rapid heart beat; anxious; like something was going to happen; bathroom a couple times and felt week with the flu like symptoms, they were very bad; did eat something later yesterday, but food was flat tasting; didn't taste right; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262, Expiration date: Unknown) via intramuscular route of administration in left arm on 28Jan2021 10:00 as SINGLE DOSE for COVID-19 immunization in the clinic. Medical history included neoplasm malignant, chemotherapy, radiotherapy, immune system disorder (her immune system since has not been the same and has been very deprived) from an unknown date and unknown if ongoing. Concomitant medications included bee venom for arthropod sting. The patient experienced wasn't feeling right , dizzy, weak and very disoriented, did not feel good, terrible headache and laid down right away, things started spinning/head spinning, nauseous, flu like symptoms, flushed, very cold, chills, pain in arm, rapid heart beat, anxious, like something was going to happen, bathroom a couple times and felt week with the flu like symptoms, they were very bad, did eat something later yesterday, but food was flat tasting, didn't taste right on 28Jan2021 and her immune system since has not been the same and has been very deprived on an unspecified date. the first Covid shot yesterday at 10:00. They had her to sit for 15 minutes to make sure she was okay to walk. About 7-8 minutes she noticed she wasn't feeling right, dizzy, weak and very disoriented. She got up and didn't want to create a scene and started walking through the clinic and stopped to ask the receptionist to call her husband in the car. There was so many people so she just kept walking and luckily was able to get to car and told her husband she did not feel good. By then she had a terrible headache and when she got home she laid down right away. Then things started spinning and she was very nauseous and is aware that these things can happen with the vaccine. Had flu like symptoms like she never had before, but this was worse. She did not have a fever, but was flushed and very cold, chills. Her arm was not hurting until about 9pm and during the night she had a rapid heart beat, but not really. Was very anxious like something was going to happen and she tried to calm herself by taking deep breaths but does not know if that worked. Finally, after 3 hours she was able to go to sleep and did go to the bathroom a couple times and felt week with the flu like symptoms, they were very bad. When she got up today she was 60-65% better. She did eat something later yesterday and had thought the nausea was because she hadn't eaten all day long. The food was flat tasting and she know she has that whenever she has the flu where nothing tastes right. She clarifies she has that anyway since 16 years ago she had cancer and a strong dose of chemotherapy and radiation and her immune system since has not been the same and has been very deprived. Whenever she gets sick she gets deathly sick and has to be watched or she may have to get hospitalized due to weakened immune system. States some people say that the second dose is worse, is that true or is it the same feeling. If she feels like that with the second dose she may not get it. No further details provided. Mentions as the day goes on she comes around more. Has to get her glasses to see card given. No other vaccines given that day or 4 weeks prior. No problems with vaccines in past. The outcome of event her immune system since has not been the same and has been very deprived was unknown and other events were not recovered. No follow-up attempts are possible. No further information is expected.
78 2021-03-30 pain in extremity, flushing the pain is going up higher and higher.; I feel flush; Flu like symptoms; Arm pain; This is a sponta... Read more
the pain is going up higher and higher.; I feel flush; Flu like symptoms; Arm pain; This is a spontaneous report from a contactable consume. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3249) via an unspecified route of administration in Arm left on 21Jan2021 11:00 (Age at time of Vaccination: 78-years-old) as single dose for covid-19 immunisation.Medical history included ongoing blood pressure abnormal, arthritis, gastrooesophageal reflux disease. She also takes a medication for reflux, but does not know the name of it. The patient's concomitant medications were not reported. On 23Jan2021 the patient experienced flu like symptoms, arm pain. On an unknown date the patient stated the pain is going up higher and higher and I feel flush. She got the vaccine last thursday, on 21Jan2021. She stated she was fine the day after, but then the next day she started to get flu like symptoms. She is also having arm pain and the pain is going up higher and higher. The pain is going up behind her head, it is hurting there too. She wants to know why she has not stopped hurting. She stated she kept taking Ibuprofen thinking that was a good thing to do. However, she would only take half of it.Therapeutic measures were taken as a result of flu like symptoms, arm pain , the pain is going up higher and higher. It was reported that she is scheduled for the second dose on 11Feb2021. No prior vaccinations was given to patient within 4 weeks. The outcome of the event flu like symptoms and arm pain was not recovered and outcome of other events was unknown.
78 2021-03-30 pain in extremity Back pain; leg pain; general rib pain; This is a spontaneous report from a contactable consumer (pat... Read more
Back pain; leg pain; general rib pain; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 24Jan2021 as single dose for COVID-19 immunization in an public health department. The patient's medical history was not reported. The patient has no concomitant medications. No other vaccine was given within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced back pain, leg pain and general rib pain for the last 3 days on 24Jan2021 12:00. No treatment was received. The events were considered non-serious since it did not result in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. The outcome of the event was not recovered.
78 2021-03-30 tremor Trembling; muscle weakness; palpitations; light headed, dizziness; slight headache; This is a sponta... Read more
Trembling; muscle weakness; palpitations; light headed, dizziness; slight headache; This is a spontaneous report from a contactable other HCP. This 78-year-old female other HCP (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN6201) via an unspecified route of administration from 08Feb2021 at 1:00 pm to 08Feb2021 at 1:00 pm at single dose on right arm for covid-19 immunisation. Vaccine facility type vaccine was doctor's office/urgent care. The patient was 78 years old and not pregnant at the time of vaccination. Patient's medical history included hypothyroid, hypertension, elevated cholesterol, possible heart condition, obesity, known allergies: shellfish, MSG (dates unspecified). Concomitant medications included Losartan, hydrochlorothiazide, triamterene (Dyazide), Levothyroxine, Pravastatin via an unspecified route of administration from unspecified date to an unspecified date at unknown dose and frequency for an unknown indication. If other vaccine in four weeks: No. Patient experienced trembling, muscle weakness, palpitations. light-headed, dizziness, slight headache on 08Feb2021 at 01:15 pm. AE resulted in: Doctor or other healthcare professional office/clinic visit. If treatment AE: no, If covid prior vaccination: no, If covid tested post vaccination: no. The outcome of events was recovered on an unknown date.
78 2021-04-02 weakness Headache at base of skull 1st night (Sun), next morning all muscles ached, significant pain in many ... Read more
Headache at base of skull 1st night (Sun), next morning all muscles ached, significant pain in many joints, tremendous fatigue, inability to concentrate, dizziness. Swelling, pain, redness left arm shoulder to elbow.Took Tylenol, spent most of the day in bed. Not hungry. By Tues I felt much better, but fatigued (still needed 2 naps), little appetite. Wed continued recovery, but weak, arm continued red, swollen, painful to the touch. Today, Sunday and a week after injection, I feel normal.
78 2021-04-03 muscle spasms gained weight since COVID,she was 136 pounds and she just weighed herself and weighs 142 pounds; she... Read more
gained weight since COVID,she was 136 pounds and she just weighed herself and weighs 142 pounds; she could not step down on her left leg; Charley horse; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), dose 2 intramuscular route of administration, administered in Arm Right on 02Feb2021 17:00 as SINGLE DOSE for covid-19 immunization. Medical history included breast cancer (additional Information for Other Conditions: 19 radiations and they took out three lymph nodes on the left, she was diagnosed 3 years ago), blood pressure, 19 radiations, shingles shot. Reports she had the shingles shot a few months ago, vein disorder from Sep2020 to an unknown date. Patient was not sure if vein injections might be indicative of something and clarifies that she had vein issues in her legs had vein injections to dispose of the larger veins. She has had the vein injection a number of times throughout the years. The last time she had it done again was in Sep2020. Concomitant medications included losartan; taken for blood pressure abnormal; amlodipine besilate taken for blood pressure abnormal; tamoxifen taken for breast cancer. It was reported that, she has been taking losartan for years for blood pressure and amlodipine besylate about a year ago. The patient previously administered first dose BNT162B2 on 12Jan2021 11:30 (Lot number:EL3246), intramuscular injection in right arm for covid-19 immunization On 03Feb2021, patient experienced charley horse, gained weight since covid, she was 136 pounds and she just weighed herself and weighs 142 pounds, she could not step down on her left leg. Clinical course of events includes, patient was curious, she had her second shot at 5pm on Tuesday. Yesterday morning when she woke up at 6:30 or 7 in the morning, she could not step down on her left leg. For the last day and a half, she has had what had a bad charley horse behind her knee on the upper part of the calf. She was asking if the vaccine has any indications of a blood clot. Reports she was sitting in a car for 5 hours waiting to get the vaccine. She plays golf, stays busy, she does a lot, she was not someone that is very stagnant normally. When she went to get out of bed, she could not put her foot down, she was limping. She cannot step down without being in pain. She was trying to walk now. Therapeutic measures were taken as a result of charley horse, she could not step down on her left leg. She read walking was good and drinking water, drinking tea, she did a warm compress four times this morning. The outcome for the charley horse, she could not step down on her left leg was recovering and outcome for gained weight since covid, she was 136 pounds and she just weighed herself and weighs 142 pounds and was unknown.
78 2021-04-03 paralysis felt paralyzed and nauseous; felt paralyzed and nauseous; fever; This is a spontaneous report from a... Read more
felt paralyzed and nauseous; felt paralyzed and nauseous; fever; This is a spontaneous report from a contactable consumer. A 78-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 via antibodies test on an unspecified date with positive result. On an unspecified date, a day after receiving the vaccine, the patient developed a fever and said that she felt paralyzed and nauseous. The patient needed to go to the hospital in order to recover and tested positive for antibodies. The outcome of events, fever, felt paralyzed and nauseous was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
78 2021-04-04 weakness Weakness, Dizziness, Garbled speech
78 2021-04-05 weakness, tingling 3/3/2021 - Left Upper Arm Swollen Hard Muscle, no Pain, 3/8/2021 - Periodic Tingling up and down be... Read more
3/3/2021 - Left Upper Arm Swollen Hard Muscle, no Pain, 3/8/2021 - Periodic Tingling up and down beneath skin of Left Arm,in addition to Swollen Muscle Applied Cold Compresses and Tylenol Caplets with relief of tingling sensations 3/16/2021 - Covid Pfizer Vaccine #2 (Right Arm) - only temporary small bruise spot at injection site 3/25/2021 - Urgent Care for Swollen Upper Left Arm and unchanged Tingling discomfort (Advised to continue Cold Compresses and follow up with Primary Care Provider) 3/29/2021 - Left Arm increasing pain up to Shoulder and Neck - weakened arm strength, use challenge, and sleep discomfort 4/12/2021 Earliest Upcoming Appointment with my Primary Care Provider
78 2021-04-05 weakness She got the vaccine, had no reactions. She told them that she was going to have a procedure and th... Read more
She got the vaccine, had no reactions. She told them that she was going to have a procedure and they told her that it would be okay for her to have the vaccine. Then she had the procedure on 3/25/21 and then 2 days later she lost the use of her legs. She has fatigue, no energy whatsoever, it took 3 days for her to be able to get up and walk, and slept on the floor as she could not use her legs to get into the bed. She did call her doctor about 5 days later and he thought that it could have been a combination of the vaccine and anesthesia from the procedure. She continues to have the fatigue and no energy whatsoever.
78 2021-04-06 numbness, pain in extremity, tingling pt states that she has sore left arm. Pt has metal screws and plates in her left ankle and later th... Read more
pt states that she has sore left arm. Pt has metal screws and plates in her left ankle and later that night after getting the vax she got severe shooting pain in left ankle. This pain lasted about 15 or 20 minutes. Today 4/7/2021 about 11 AM she started feeling like she has an exposed nerve in her mouth. She said the pain traveled through her mouth, to her ear, then to her head. She says it is now numb and tingling. She has a rod in her femur to her hip and so far has not had any pain in that location. Pt says called her PCP and she was instructed to take Tylenol or go to the ER if her pain persist.
78 2021-04-07 weakness fever up to 101 degrees; weakness; Body aches; headache; exhaustion; Chills for 3 hours; This is a s... Read more
fever up to 101 degrees; weakness; Body aches; headache; exhaustion; Chills for 3 hours; This is a spontaneous report received from a contactable (reporting on herself). A 78-years-old Non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6201 and Expiry date not reported), via an unspecified route of administration in Arm Left on 11Feb2021 16:45 as single dose for COVID-19 immunization. Medical history included penicillin allergy. The historical vaccine first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283 in Arm Right on 22Jan2021 17:15 for COVID-19 immunization. Concomitant medication(s) included Liothyronine/Levothyroxine T3/T4, and usual vitamin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that on 12Feb2021 at 13:00 symptoms started (at 20 hours after the injection) Chills for 3 hours, fever up to 101 degrees, weakness, body aches, headaches, exhaustion. Patient did not received any treatment for adverse event. The patient was not tested for COVID-19 post vaccination. The outcome of the events was recovering.
78 2021-04-07 numbness, paralysis Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Numbne... Read more
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: 24 hours after vaccination patient experienced paralysis and was rushed to ER where ER physician said reaction was most probably due to the vaccine. patient recovered within 2 weeks. MD said patient can get 2nd dose but patient has refused second appointment for vaccination,
78 2021-04-07 pain in extremity Sore neck was reported as worsened; Sore neck; sore arm; This is a spontaneous report from a contact... Read more
Sore neck was reported as worsened; Sore neck; sore arm; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), intramuscular, administered in Arm Left on 17Feb2021 12:08 (Batch/Lot Number: EM9809; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included stiff neck. There were no concomitant medications. The caller explains the arm soreness developed on 17Feb2021 after she got home from receiving the vaccine. She couldn't sleep on her left side, which she is used to doing that. She hasn't slept on her left side still. Right now, where the needle went is a little sore, but her arm is okay. Her neck just hurts. The caller states her neck started to get sore probably last night while she was sleeping. She had a little bit of sore neck yesterday (18Feb2021) and last night. But, she woke up this morning and it was worse. She could move her neck and everything up until this morning. The outcome of the events sore arm was reported as recovering. The outcome of the event Sore neck was reported as not recovered. The outcome of the event Sore neck was reported as worsened was reported as unknown.
78 2021-04-08 weakness 3/27 got 1st pfizer vaccine in her right arm had injection site pain for a week and finally resolv... Read more
3/27 got 1st pfizer vaccine in her right arm had injection site pain for a week and finally resolved the next day woke up with severe right arm pain, hurts to lift it sleeps on side and this also hurts it no weakness but hurts to raise it up no prior injuries no trauma pain in lateral shoulder, minimal neck pain, no pain distal to elbow no numbness or tingling on warfarin so has been afraid to take anything for this pain 5/10 at rest and much worse with movement
78 2021-04-08 pain in extremity Pt states that 3 days after her Pfizer covid vaccine, she developed swelling and pain of left hand. ... Read more
Pt states that 3 days after her Pfizer covid vaccine, she developed swelling and pain of left hand. Doctors notes state she was diagnosed with gout with a Uric acid of 8. The doctor states the covid vaccine could trigger gout and that she is taking HCTZ which can predispose. This was the pt's first episode of gout. She was treated with a medrol pak. Doctor's notes state that pt improved 1 day after taking steroids. she has not had any recurrence of gout.
78 2021-04-09 pain in extremity, tingling 2/24/2021 thru 3/1/2021 - Left Arm pain and tenderness at injection site - less pain each day. Trea... Read more
2/24/2021 thru 3/1/2021 - Left Arm pain and tenderness at injection site - less pain each day. Treatment: Tylenol Caplets (temporary relief) 3/3/2021 - Left Upper Arm Tricep Muscle noticeably Swollen and Hard when touched- No pain. Treatment: Cold compresses (little relief) 3/8/2021 - Left Arm Periodic Tingling up and down under skin, in addition to Swollen Tricep Muscle Treatment: Cold compresses & Tylenol Caplets (temporary relief) 3/25/2021 - Urgent Care for Swollen Upper Arm & Tingling discomfort Advice: Continue Cold Compresses, Monitor and follow up with Primary Care Provider 3/29/2021 - Continued Left Arm Tingling and increasing Pain at Left Upper Back & Shoulder, weakening Left Arm Strength, usage challenge, sleep discomfort, Tricep Muscle less swoIlen, Treatment: Cold Compresses and Tylenol (temporary relief) 4/12/2021 - (Pending) earliest available appointment with my Primary Care Provider
78 2021-04-09 pain in extremity it began working up her arm with arm pain and chest pain which persisted and she went to the hospita... Read more
it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours; it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours; blood pressure went up to 198/203; still has tiredness; difficulty swallowing like her throat is still tight; difficulty swallowing like her throat is still tight; short of breath; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), first dose via an unspecified route of administration, administered in Arm Right on 11Mar2021 11:00, single dose for covid-19 immunisation. Medical history included silent heart attack, ongoing Barrett's oesophagus from 2008, fall she had over two months (2021), eye surgery on an unknown date. She does not get any shots and can't have shots even for the flu shot because she had problems with two flu shots she had; states she had a problem with each one of the flu shots and does not know the names of the flu shots and has no lot numbers to provide for them; states she had the flu shots in the early 1990's and worked in healthcare and had to have them and they told her back then if she wanted to work she had to have the flu shots and then she got sick with both of the flu shots and they said they guessed they would not force her to have the flu shots. The patient's concomitant medications were not reported. Patient had the first dose administered and then about 14 hours after (12Mar2021) that she had no problems until it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours. She does not know what to do about getting the 2nd dose of the vaccine and was at her cardiologist's this week and he said he is not familiar with the Pfizer vaccine causing chest pain; caller states she has a history of silent heart attacks. She still has tiredness and difficulty swallowing like her throat is still tight and they told her to mention if she does go for the second dose of the vaccine to mention that she had this situation.The chest pain and arm pain began 12Mar2021 and the arm pain is in her right arm where the vaccine was administered and the arm pain and chest pain have resolved; states the arm pain and chest pain stopped and she thinks that lasted about an hour and a half and she called a family member to take her to the hospital; states about 2:30am that same day she was admitted the morning of 12Mar2021 and was discharged on 13Mar2021. They ran every test known to the patient and for a while her blood pressure went up to 198/203 in the emergency room (12Mar2021) and she is not on any medication; caller states she does have Crestor but has not started on it and has not taken it yet. The tiredness and difficulty swallowing like her throat is still tight began the same time she was having the chest pain and she is not having any chest pain or anything like that right now but the tiredness and difficulty swallowing like her throat is still tight is still ongoing; states she did go get cardiac clearance to make sure which was this past week and she does not feel well and like for her the tiredness is bugging her. The tiredness and difficulty swallowing are better but she knows they are there and she tries to swallow something and is like boy her throat is still tight. They did an ultrasound in her left leg because she was limping from a fall she had over two months ago but still has a sore ankle from that and they sent her down for the ultrasound and a CT looking for blood clots in her lungs because she was short of breath (12Mar2021); caller states she thinks they were running everything they could to rule out things; states everything was negative for the CT and ultrasound and she believes the CT and ultrasound were done on 12Mar2021. She has no idea when she was diagnosed with silent heart attacks but they kept asking her about this when she went in for eye surgery and asked her when she had a heart attack and she said she had never had one and they said yes she had and she never knew. She just set up a HCP appointment after the reported events with a gastroenterologist because she has Barrett's and because of the esophagus she did not know if it flared up by the Pfizer vaccine and that caused the pain because the two pains of the heart and esophagus mimic each other with pain going up into the jaw so they were ruling out which one it was; states she went out as an atypical chest pain and called the cardiologist and went in and went over her records from the hospital with the cardiologist. She does not know what caused what in terms of the pain. The outcome of the event blood pressure increased was unknown, chest pain and pain in arm was recovered, other events was recovering.
78 2021-04-09 pain in extremity Generally feeling sick, possible light fever, headache, sore ears, sore teeth, very sore upper arm.
78 2021-04-11 burning sensation rushing noise in my head or ear burning in my hands finger locking
78 2021-04-12 weakness, feeling hot, tremor, feeling cold passed out for a very short period of time; was awakened by total body shaking and it was not just ... Read more
passed out for a very short period of time; was awakened by total body shaking and it was not just shivers but was uncontrollable shaking; her body felt warm but then she was freezing; her body felt warm but then she was freezing; was sick and was different and very weak; muscles were sore; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)), via an unspecified route of administration, administered in the left arm on 17Mar2021 12:10 (Batch/Lot Number: EN6207; Expiration Date: 31May2021) as a single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of the Pfizer BioNTech COVID19 vaccine on 23Feb2021 (lot number: EN6198 with expiry date 31May2021) for Covid-19 immunization. The patient experienced passed out for a very short period of time and awakened by total body shaking and it was not just shivers but was uncontrollable shaking on 18Mar2021; her body felt warm but then she was freezing, she was sick and was different and very weak, and muscles were sore in Mar2021. It was further reported that the patient got the 2nd dose of the Pfizer BioNTech vaccine that day on 17Mar2021 and about 12:45am or 1:30am the next morning she was awakened by total body shaking and it was not just shivers but was uncontrollable shaking; the shaking has resolved completely but she is not sure when it resolved but she was shaking for a good while because she can remember being so uncomfortable with her body moving so much which went on for maybe 20 minutes or so when her husband woke up.Patient's husband then woke up and got Ibuprofen and gave it to her and that stopped the shaking which surprised her and she did not know the Ibuprofen would work to stop the shaking that well and the Ibuprofen did work in stopping the shaking. The Ibuprofen stopped the shaking and she can remember to touch her body felt warm but then she was freezing and she does not know what this means but this was not ongoing and resolved when her husband gave her the ibuprofen and she stopped shaking right away which always amazed her that the Ibuprofen worked. She stated fortunately the Ibuprofen stopped her from shaking and she was able to sleep until early morning when she woke up and knew she was sick and was different and very weak; states the weakness was not ongoing and the approximate time the weakness resolved was unknown but she was down the rest of the day and after that she passed out for a very short period of time and held her head up and stood up and thought wow something was going on and asked where was this coming from and it was not nausea but she was just weak. She has not passed out for a huge amount of time but fortunately she had some towels laying close by and was able to use a towel; states after that she stopped for the rest of the day and only got up to go to the potty and was just so weak and heard that from many people that they just slept afterwards.Caller states her muscles were sore and she realized that was just normal and after the 2nd dose of the vaccine she knew her muscles would probably be sore and this was resolved. She came downstairs and was sitting on a chair and then stood and no longer sat in the chair and her husband knew things were not right with her and her eyes looked funny and she passed out and that never happened to her before and she was passed out for a few moments. Other than the Ibuprofen she did not have treatment and did not go to the emergency room or the HCP office. Patient only took one Ibuprofen and she has a very small body and her husband sometimes takes 2-3 Ibuprofen and she thinks wow that is so many but she herself does not have any medication and she just took one Ibuprofen and it worked; She took the Ibuprofen on 18Mar2021 in the early morning. Fortunately she was in good health. Outcome of the event passed out for a very short period of time, was awakened by total body shaking and it was not just shivers but was uncontrollable shaking and muscles were sore was recovered in Mar2021, and unknown outcome for the remaining events.
78 2021-04-12 facial paralysis, speech disorder 3/17: dizzyness attributed to hunger, ate, went to bed. 3/18: unsteadiness walking, difficulty eati... Read more
3/17: dizzyness attributed to hunger, ate, went to bed. 3/18: unsteadiness walking, difficulty eating and speaking. Did not call 911/alert family. 3/19: symptoms continued. Daughter observed symptoms, including facial droop, and transported to local hospital ED. 3/20: discharged without seeing neurologist. CT scan and other tests failed to show stroke. However, MRI not performed. 3/22: outpatient visit to neurologist who, based on symptoms, concluded stroke had occured on left side of brain due to COVID 19 vaccine. 3/24: MRI performed and shows stroke. 3/30: MD orders additional tests. 4/1: admitted to Rehab. Hospital for 9 days.
78 2021-04-12 pain in extremity Arm started hurting the next day. Hard to lift arm above shoulder. Did not get better. After a m... Read more
Arm started hurting the next day. Hard to lift arm above shoulder. Did not get better. After a month I called the dr. and was told to take 2 naproxen twice a day to relive swelling. T his helped, but when I stopped the pain came back. Does not hurt just sitting, only when I try to lift something. Think injection was given in a muscle. Hurts when I left arm above shoulder.
78 2021-04-14 pain in extremity, numbness, paralysis Critical Limb Ischemia Symptoms: Progressive BL lower extremity and back pain starting on 3/20/2021... Read more
Critical Limb Ischemia Symptoms: Progressive BL lower extremity and back pain starting on 3/20/2021. She presented to the ED twice and DVT ultrasound and lumbar spine CT showed no acute findings. Symptoms progressed to the point of severe pain on 4/1/2021 with toe numbness and paralysis. CTA of BL lower extremities was performed showing bilateral arterial thrombus. She underwent bilateral common femoral artery thromboembolectomy with vascular surgery. Of note, patient was on eliquis 5 mg BID given history of PE in 2018. She was compliant with this medication.
78 2021-04-14 pain in extremity Patient had ED visit with leg swelling and pain that resulted in right mid femoral DVT discharged ho... Read more
Patient had ED visit with leg swelling and pain that resulted in right mid femoral DVT discharged home from ED with apixaban.
78 2021-04-17 weakness Pneumonia after getting the COVID Vaccine; Pneumonia was related to MRSA; Very weak; mild fever; Thi... Read more
Pneumonia after getting the COVID Vaccine; Pneumonia was related to MRSA; Very weak; mild fever; This is spontaneous report received from a contactable consumer (patient's husband). A 78-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 78-years-old, administered in arm on 25Feb2021 15:45 (Lot Number: EN6202) as single dose for COVID-19 immunization. Medical history included diabetes mellitus from 2011 (Verbatim: Diabetic; Diagnosed 10 years ago), rheumatoid arthritis from 1995 (Verbatim: Rheumatoid arthritis; Diagnosed in 1995), cardiac failure congestive from Oct2020 (Verbatim: Congestive Heart Failure), adrenal insufficiency from 1990 (Verbatim: Adrenal insufficiency; Diagnosed in probably 1990), atrial fibrillation from 2017 (Verbatim: Atrial fibrillation; Diagnosed 4 years ago). Concomitant medication included unspecified medications ("she takes lots of medications. Too long of list she probably takes 15 different medications, reporter chose not to provide them). No-other vaccines were given at the same time. She gets the flu vaccine every year, shingles vaccines, pneumonia vaccines every year but, has no idea where they were manufactured. Confirmed she did not get the listed vaccines at the same time she got the COVID Vaccine. The patient's husband and the patient (his wife) both received their 1st COVID shot on the 25Feb2021 and was scheduled for 3 weeks later. He got his COVID on the 18Mar2021. The patient got Pneumonia and was admitted to the hospital but he does not know the exact time the Pneumonia started. It developed over a period of several day started with a mild fever (in Mar2021) and after the 2nd or 3rd day her fever spiked and that's when she was admitted to the hospital. He reports his wife went into the hospital with Pneumonia on 18Mar2021, the day she was supposed to get the 2nd shot. It was also reported that Pneumonia was related to MRSA. She laid up in the hospital for 2 weeks, the weakness ("very weak") may have happened in the hospital or a few days before, date was confirmed to be on 15Mar2021. The event "pneumonia" was totally unrelated to COVID and now she is in a nursing home, she went in on 26Mar2021. She probably won't be able to have the 2nd shot for a couple of weeks. She was in there for a couple of weeks and still quarantined. He wanted to know will the fact that she is not getting the 2nd shot at the 3-week interval reduce the efficacy of the vaccine since she is getting the 2nd dose late. Does it make a difference with the effectiveness of the vaccine if she's going take the 2nd dose 3-4 weeks or even a month and a half rather than the usual 21 days interval? No treatment before going to the hospital other than calling the doctor and the doctor saying take her to the hospital (not reported if patient received treatment during hospital stay). No treatment done over the weekend, while she was in the nursing home. The adverse event pneumonia required a visit to Emergency Room. The patient was hospitalized from 18Mar2021 to 26Mar2021. Investigations included had a lot of blood work done, a CT scan, an X-ray on unspecified dates. He does not have any of the results but, the physicians have them. The outcome of the event mild fever was unknown, for very weak was not recovered while for the rest of the events was recovered on 26Mar2021.
78 2021-04-17 tingling, numbness 78 Y/O FEMALE C/O NUMBNESS/TINGLING TO LEFT HAND. NO OTHER COMPLAIINTS PT MONITORED BY EMS UNTIL 10:... Read more
78 Y/O FEMALE C/O NUMBNESS/TINGLING TO LEFT HAND. NO OTHER COMPLAIINTS PT MONITORED BY EMS UNTIL 10:45 A.M, PT STATED SYMPTOMS STARTED TO SUBSIDE. PT THEN CLEARED ADVISED IF SYMPTOMS RETURN TO SEEK MEDICAL ATTENTION PER EMS.
78 2021-04-18 bell's palsy Bell's Palsy/facial paralysis; Bell's Palsy/facial paralysis; This is a spontaneous report received ... Read more
Bell's Palsy/facial paralysis; Bell's Palsy/facial paralysis; This is a spontaneous report received from a consumer (patient's husband). A 78-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, at age 78 years, administered in right bicep on 16Mar2021 09:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Patient's medical history includes bells palsy from 1997, lower right lobe of her lung removed in 2016, and removed for carcinoid tumor on an unspecified date. Patient did not have prior vaccinations in 4 weeks. Concomitant medications were none. There were no other vaccines administered on the same date as the suspect. Patient previously too quite a few medications but she hasn't been taking for years or that would affect it. It was reported that patient and the reporter received first dose on 16Mar2021 at 09:00 AM in the right bicep as recommended by the pulmonologist and oncologist. It was reported that on 29Mar2021, also reported as "13 days later from vaccination", facial paralysis started around noon. At the time of report, patient was experiencing Bell's Palsy from 29Mar2021 and asking for recommendation for second dose. Patient was also officially diagnosed with Bell's Palsy when she went to the ER on 31Mar2021. Patient has seen the doctor and been to the ER and the doctor refused to comment saying he had no opinion, they had asked him if she should do the second dose and he said he had no opinion. Reporter relayed that on the website there is no specific notable balance in the numerical groups to suggest a causal relationship to the vaccine. Reporter was asking if the second dose was prohibited, stating patient was scheduled for 06Apr2021 which is 21 days after her first dose. Patient's husband spoke from the FDA's briefing document that "Bell's palsy was reported by four vaccine participants and none in the placebo group. These cases occurred at 3, 9, 37, and 48 days after vaccination," and mentioned that there have been 4 reports of Bell's Palsy during the study and 1 of those was after the first dose and 3 were after the second dose. They wanted to know if it is allowed should she get it or could it be rescheduled to a later date. For tests, no testing was done they just did a visual exam on an unspecified date. Vaccine was not administered at Facility. The outcome was unknown. Information about lot/batch number is requested.
78 2021-04-19 tenderness swollen lymph node in my left arm pit that was red and tender to the touch. Swelling and tendernes... Read more
swollen lymph node in my left arm pit that was red and tender to the touch. Swelling and tenderness disappeared in approximately 25 days. Dr viewed it on April 13th & confirmed it was a swollen lymph node
78 2021-04-20 pain in extremity Acute headache radiating to neck and right shoulder and right eye. Acute hypertension with hypertens... Read more
Acute headache radiating to neck and right shoulder and right eye. Acute hypertension with hypertensive crisis BP 223/113 needing Emergency department admission. Following this ED visit the the BP had been uncontrolled with ongoing headaches and right sided neck pain radiating to the right eye/head through March and in April have improved. During this time had #2 Pfizer vaccine 2/12/21 and had experienced arm pain and headache as well as a spike in her BPs as well as right sided neck pain radiating to her right eye
78 2021-04-24 weakness Blood clots in Lungs; No longer able to do activities of daily living; Almost fell to floor from sit... Read more
Blood clots in Lungs; No longer able to do activities of daily living; Almost fell to floor from sitting position; short of breath; total body exhaustion/fatigue; sleepy throughout the day; unstable, weak; debilitating symptoms bedridden/unstable, weak; debilitating symptoms bedridden; passed out completely while sitting; Unable to complete daily 1 mile walk at park/Unable to take stairs; Lightheaded/dizzy; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 26Mar2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included patient had COVID-19 Dec2021 and recovered completely in 2 weeks. Symptoms: fever, sleepy. Went back to daily walk after 2 weeks. No loss of smell, no loss of taste, no mental changes- was very happy with my complete recovery. Took vaccine 26Mar2021 at recommendation of doctor to be safe from variants. Regret deeply, still hospitalized as of this writing. Concomitant medications included ramipril; rosuvastatin calcium 40mg; levothyroxine, all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulphur and experienced allergies. The patient experienced unable to complete daily 1 mile walk at park/unable to take stairs on 27Mar2021, lightheaded/dizzy on 27Mar2021, passed out completely while sitting on 28Mar2021, unstable, weak on 30Mar2021, short of breath on 31Mar2021, total body exhaustion/fatigue on 31Mar2021, sleepy throughout the day on 31Mar2021, almost fell to floor from sitting position on 09Apr2021, debilitating symptoms bedridden/unstable, weak on 26Mar2021, debilitating symptoms bedridden on 26Mar2021, no longer able to do activities of daily living on 13Apr2021, blood clots in lungs on 14Apr2021, all with outcome of not recovered. Reported adverse event: 27Mar2021 - Unable to complete daily 1 mile walk at park. Lightheaded, dizzy 28Mar2021 Dizzy, passed out completely while sitting. Revived and taken to hospital by ambulance 28Mar2021 Admitted to (hospital name withheld) 30Mar2021 Discharge from hospital - unstable, weak 31Mar- 08Apr2021 - short of breath easily. Unable to take stairs. Discontinued daily walk, weak, total body exhaustion, sleepy throughout the day 09Apr2021 - Almost fell to floor from sitting position. Patient's daughter lowered patient gently to the floor. Revived shortly 13Apr2021 Saw primary doctor Dr (name withheld). Shared her debilitating symptoms bedridden since Covid-19 vaccine on 26Mar. BP taken from lying down, sitting and standing was markedly different and explained caused passing out and lightheaded. No longer able to do activities of daily living 14Apr2021 - Exhaustion and fatigue, her daughter to her back to the hospital 14Apr2021 - Passed out in Emergency Room @ (hospital name withheld). Admitted. Blood clots in LUNGS. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for unable to complete daily 1 mile walk at park/unable to take stairs, lightheaded/dizzy, passed out completely while sitting, all from 28Mar2021 to 30Mar2021. The patient underwent lab tests which included blood pressure measurement: markedly different on unknown date. Patient was not pregnant. No other vaccine in four weeks.Patient had covid prior vaccination. No covid tested post vaccination. The treatment received for events included Heparin administered, still hospitalized as of now. Information about Lot/ Batch number has been requested.
78 2021-04-24 weakness nauseous; feeling unwell; Chest heaviness; Chills; Fatigue; her quality of life was low and getting ... Read more
nauseous; feeling unwell; Chest heaviness; Chills; Fatigue; her quality of life was low and getting worse everyday; Weakness; swollen lymph nodes in neck and groin; irregular fast heartbeats; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 01Mar2021 (Batch/Lot Number: EN6200), at single dose, for COVID-19 immunisation. Medical history included lymphadenectomy, thyroidectomy (in 2014 or 2017), COVID-19 from Feb2020 to an unknown date (not ongoing). Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation (lot# EL9269) intramuscular in left arm and experienced vaccination site swelling and azithromycin (ZITHROMAX) and experienced drug intolerance and illness. The patient experienced weakness (disability) in 2021 with outcome of not recovered, swollen lymph nodes in neck and groin (disability) in 2021 with outcome of not recovered, chest heaviness (disability) on 07Apr2021 with outcome of not recovered, fatigue (disability) in 2021 with outcome of not recovered, her quality of life was low and getting worse everyday(disability) in 2021 with outcome of unknown, chills (disability) on 07Apr2021 with outcome of unknown, nauseous (disability) on 08Apr2021 with outcome of unknown, dizziness (disability) in 2021 with outcome of not recovered, feeling unwell (disability) on 08Apr2021 with outcome of unknown, irregular fast heartbeats (disability, medically significant) in 2021 with outcome of recovered in 2021. Therapeutic measures were taken as a result of the events and included treatment with 1 Baby Aspirin. The reporter (patient) considered all these symptoms she was reporting were disabling because she had no quality of life. No follow-up attempts are needed. No further information is expected.
78 2021-04-24 nerve pain, trigeminal neuralgia, tingling, numbness nerve pain in face; Tooth pain; severe nerve pain left ankle/nerve pain in mouth/pain in her legs/pa... Read more
nerve pain in face; Tooth pain; severe nerve pain left ankle/nerve pain in mouth/pain in her legs/pain in the calf; Numbness. It affects my face and head. Anything that goes to your brain.; feels numbness/feels it in her eye too; Deep pain.; trigeminal neuralgia; severe damage in both legs; tingling; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021, at the age of 78-year-old, (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included ongoing Allergies. The patient had allergies to ciprofloxacin (CIPRO), clindamycin, amoxicillin, penicillin, sulfamethoxazole; trimethoprim (BACTRIM), cefalexin monohydrate (KEFLEX), clarithromycin (MACROBID), levofloxacin (LEVAQUIN), valsartan (DIOVAN) (blood pressure med). Some of them allergic and can never take. Some have minor effects like itching or rashes, allergic reaction to dairy, the enzyme, not the lactose. The patient had bloodwork 2 weeks before the vaccine (in Mar2021) to see if there were any antibodies. Stated that she not only had the short test and the long test but that she went for the blood test that showed no antibodies and was told she could take the shot. Stated that she has taken blood pressure medicine every day since she was 29. No prior vaccinations within 4 weeks. No AEs following prior vaccinations, no family medical history, no relevant tests. Stated that she had an accident that promoted a lot of her nerve damage. No history of all previously immunizations, no additional vaccines administered on same date. The patient had plates and screws. Rod attaches to her hip. Metal Clips in shoulders. Severe spinal stenosis. Rotator cuff operation. Arthritis and a scar in her arm. Concomitant medications included levothyroxine sodium (SYNTHROID) been taking more than 15 years for thyroid, start and stop date were not reported; ongoing hydrochlorothiazide taken for an unspecified indication, start was not reported and stated that this is a water pill that she takes as part of her program; ongoing amlodipine besilate (NORVASC) taken for an unspecified indication, has been taking since age 29; ongoing budesonide (NASOCORT) taken for allergies, Stated that she did take on the day she received the vaccine. Have a lot of pollen down here; ongoing hydrocortisone taken for an unspecified indication, start was not reported, Only takes half of that, takes 2.5mg. Doctor thinks it doesn't do anything, that it's like taking 3 Advil and Has been taking on and off only at night did not take it Monday night. ongoing Coreg -Has been taking since age 29. Ongoing desloratadine (CLARINEX) for allergies, ongoing Vitamin D nos and states she takes either 1000 or 2000 in liquid form for unspecified indication; ongoing Magnesium (Powdered drink mix) for unspecified indication and ongoing ascorbic acid (VITAMIN C) for an unspecified indication. The patient experienced severe nerve pain left ankle on 06Apr2021 (it happened later that night, after 2 or 3 in the morning, so it was 06Apr2021), nerve pain in mouth and face on 07Apr2021, Had plates and screws, so knows the difference between hurting and nerve pain. She experiences pain constantly every day. This was severe nerve pain. Stated that just the ankle was severe. Stated that when she woke up, she already felt pain in her legs. States that she also had pain in the calf but didn't pay much attention because the pain was mostly in her ankle. States that it was where the metal was and went on for about 15 or 20 minutes. States that it has subsided. None treatment received. The patient experienced tooth pain and states that this started today (07Apr2021) around 10:30 or 11:00 this morning. States that all of a sudden felt an exposed nerve in the tooth, like the worst toothache you've ever had. States that it was pretty devastating and nerve pain really hurts a lot. States that she knows you don't have to have exposed nerve to know. States that it started on her face on the left side, the way neuralgia starts and goes to the eye, all on the left side, same side as the shot. States that it was weird to her. The patient was told by her doctor to take Tylenol but she did not take it because it really doesn't work. States that she can't feel everywhere. States that she would like to know what is going on and she still feels numbness (in Apr2021). States that her face is not numb but feels numb-ish, and can't even explain it. States that she feels it in her eye too. States that it feels better now then when she first noticed it. States that she will take something eventually if it keeps up. Caller states that when getting the shot, she told the man that she already had a scar in the right arm from a full rotator cuff. States that she is leery of the shot. The patient had numbness. It affects my face and head. Anything that goes to your brain on an unspecified date. She wanted to know if any metal in their body metal ankle screws in place 47 years. Rod attaches to her hip. Metal Clips in shoulders. Trigeminal neuralgia. Nerve that goes to face. Severe spinal stenosis. Vaccine in left arm. Rotator cuff operation. Talked to HCP. He is going to leave it up. She just don't want to experience a bad reaction. Deep pain. Eye and Face. Left arm. Did not affect the rod. Affected all the nerves on the left side. Supposed to get the shot the 26th. Now this to her face. It makes she think do she want that shot to her brain. That's what makes she wonder. HCP told to take Tylenol 500mg or go to ER. She chose not to go to ER. Asking if this adverse event has been reported and if she should receive second dose. States that she had the vaccine on Monday 05Apr2021, on that night. States that are several things wrong with her and she questioned everyone about taking it. States that she did report today (07Apr2021) about her recent experience. Is not sure whether she wants to take the second shot. States that she has severe damage in both legs. States that she has trigeminal neuralgia. States that she has middle ankle screws and plates that she has had for 47 years on her left side. She have arthritis. On the right side, from the femur to the hip, she has a rod attached there. Has severe spinal stenosis and has long lasting problems. States that this is why she was worried about taking the shot. States that all of her doctors said to really take it because she is 78 years old, so she took it. States that Monday night (05Apr2021), she got the shot in the left side of her body. States that the person giving her the shot noticed a scar in her arm in the muscle area. States that she had one of many operations on that shoulder, including the rotator cuff. States that he asked her if there was any metal in there and she stated that there probably is metal in there, or clips, does not know for sure if metal. States that he went ahead and gave the shot. States that on Monday at about 2 or 3, she woke up with severe nerve pain in that ankle area. States that she has had other things long enough to know that the nerves were affected. States that it subsided after 15 minutes or so. Today (07Apr2021), got up and felt like an exposed nerve in her mouth, then from her face to her brain. States that she put heat on it, states that she knows things to do and knows that it is not exposed nerve. States that right now it is acting up a little and feels like exposed nerve and a little tingling and numb (in Apr2021). Caller states that she figured they didn't find anything about people who have metal in their body. States that she does not take meds for nerve damage because she chooses not to. States that they are rough medications. States she is kind of leery about taking the second shot. The events did not require emergency room and physician's office. The outcome of the event severe nerve pain was recovered on 06Apr2021; the outcome of the event nerve pain in face was recovering; of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
78 2021-04-24 pain in extremity little bit of a sore arm; This is a spontaneous report from a contactable consumer. A 78-years-old f... Read more
little bit of a sore arm; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9266) via an unspecified route of administration, administered in left arm on 16Feb2021 at a single dose for COVID-19 immunization. Medical history included ongoing osteoporosis and Degenerative vertebrae and covid. Concomitant medication included calcium lactate and ubidecarenone (COQ-10). The patient experienced little bit of a sore arm on an unspecified date. Patient had Covid and she had no effect and showed no effect at all. The patient underwent lab tests and procedures which included covid-19 positive. The outcome of the event was unknown.
78 2021-04-24 speech disorder, restless legs syndrome Sundowning/sundowners; feel tired/Tiredness; headache on right side of head/not terrible, not like a... Read more
Sundowning/sundowners; feel tired/Tiredness; headache on right side of head/not terrible, not like a hangover; Muscle pain/all over her body; chills; low temperature/was just a couple digits off; Joint pain/all over her body; during these days that she felt so awful she couldn't work her way through it; had a bad spell; felt bad; restless legs; felt unwell; tossing and turning, trouble sleeping; tossing and turning, trouble sleeping/did not sleep except for a couple of times; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199 and expiration date: Jun2021, via an unspecified route of administration, administered in right arm on 15Mar2021 as single dose for Covid-19 immunisation. Medical history included arthritis, diabetes, hypertension, rotator cuff repair, cancer (mom and dad both have passed from it. two uncles and grandparents have had cancer. cancer is pretty relevant in the family), alcoholism (mom and dad both have passed from it). Concomitant medication(s) included metformin taken for diabetes mellitus, metoprolol tartrate taken for hypertension, losartan potassium and lovastatin, ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). The patient stated that she was fine until a few days ago, 4 or 5 days ago she started to feel tired, headache on one side of her head, muscle pain and chills, low temperature, joint pain and just felt unwell. By the weekend the patient stated that she was down on the couch and her son was worried about her and suggested that she go to the hospital, which she refused. The patient described the headache as 'just there', states not terrible, not like a hangover. Since waking up today, she has not had a headache. She also added that she had trouble sleeping on Saturday night (03Apr2021). She stated she did not sleep except for a couple of times and she was just tossing and turning and took ibuprofen and it didn't help. The patient stated that the muscle pain and joint pain was all over her body. She had rotator cuff surgery on her right-side years ago and during this time she was carrying groceries on her own and her left shoulder started throbbing like the rotator cuff pain that she had in the past and she recognized it right away. She stated that she is not real sure if the muscle pain in her shoulder is a result of the vaccine or not. She has full of arthritis and was not sure if the pain is caused by the vaccine or not, but with her regular arthritis, if she has been sitting and gets up and walks around she is able to work her way through it, but during these days that she felt so awful she couldn't work her way through it. The patient stated that she feels like she has been suffering from sundowners but states she feels it's not related to COVID vaccine. She writes herself notes and forgets what notes mean. The patient was on hold so long with the first one. The patient had her first vaccination on March 15th and she am supposed to go back Wednesday April 7th for the second one. She had a bad spell for about 4 days last week. Today, she feel fine and have no temperature. She didn't have a temperature when she felt bad. The patient was having chills, restless legs, couldn't sleep. Now, the patient was feeling better. The patient recovered from the event headache unilateral, muscle pain, chills, body temperature decreased, generalized joint pain and feeling unwell on 05Apr2021, for events difficulty sleeping and restless was recovered on 04Apr2021. The outcome of other events was unknown.
78 2021-04-25 tingling Tingling in arm, slight hypertension. EMS called and evaluated patient. Pt. refused transport, sx ... Read more
Tingling in arm, slight hypertension. EMS called and evaluated patient. Pt. refused transport, sx resolved
78 2021-04-26 numbness Client received the COVID vaccine (Pfizer dose 2, lot #EW0179, expiration date 4/28/2021) at 1330. A... Read more
Client received the COVID vaccine (Pfizer dose 2, lot #EW0179, expiration date 4/28/2021) at 1330. At 1345, the client reported right sided numbness and bilateral jaw tightness; RN, PHN; RN responded. Vital signs were as follows: blood pressure 140/75, heart rate 83, respiratory rate 14, O2 97%. The client stated that she has no allergies, takes lipitor, eliquis, and "colon medication," and she has a medical history of COPD, asthma, cardiac arrhythmia, and high cholesterol. At 1350, 50 mg of Benadryl PO was given and water was given. The client's color was within normal limits, she was neurologically intact (alert and oriented) and in no visible distress. The client denies shortness of breath and her lungs were clear to auscultation bilaterally. At 1355, the client's vital signs were: 96% O2, heart rate 89, temp 98.5, At 1401, the client stated that the numbness had decreased. Her blood pressure was 130/66, O2 99%, heart rate 92, respiratory rate 16. The client stated she did eat and drink today. At 1410, the client's blood pressure was 135/72, O2 96%, and heart rate 75. The client stated her symptoms had resolved at this time. Education provided regarding v-safe, emergency management, and AMR activation. At 1420, the client's vital signs were as follows: blood pressure 122/65, heart rate 72, and O2 96%. The client left at this time, ambulating to her car with a steady gait.
78 2021-04-27 mild one side paralysis, slurring, facial paralysis Approximately 5 minutes after vaccine patient had a suspected stroke. Patient was in observation ar... Read more
Approximately 5 minutes after vaccine patient had a suspected stroke. Patient was in observation area and reported right side weakness, facial droop and slurred speech. Patient was attended to by EMS service and transported to a local hospital.
78 2021-04-27 pain in extremity tongue was not manageable; throat was swollen; terrible headache; arm started hurting; fever of abou... Read more
tongue was not manageable; throat was swollen; terrible headache; arm started hurting; fever of about 99.9; Feeling sick; stomach starting throwing up and patient was throwing up; started having trouble breathing and could not breath; breathing got worse; I started having trouble breathing and I could not breath; my breathing got worse; could not swallow, could not do anything; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on 15Feb2021 (at around 12:00) as single dose for COVID-19 immunization. The patient medical history included asthma (patient had bad case of asthma, patient had that forever), thyroid (patient takes thyroid pill, natural picked thyroid a 30 mg, takes in the morning) and heart. The patient previously received the first dose of bnt162b2 (COMIRNATY) for COVID-19 immunization (at the age 78 years). Concomitant medication(s) included amlodipine besilate 5mg, cortisone, fish oil, losartan potassium 50 mg, naltrexone hydrochloride 4.5mg, prednisone 5mg, rheumagel, spironolactone 25mg and simvastatin 10mg taken for heart. On 15Feb2021, patient experienced fever of about 99.9, feeling sick, stomach starting throwing up and patient was throwing up, started having trouble breathing and could not breath; breathing got worse, could not swallow, could not do anything and that continued, terrible headache, arm started hurting. On an unspecified date, the patient experienced tongue was not manageable and throat was swollen. The patient mentioned that temperature was 97.7 in the first shot and then it was just 98.2 but on 15Feb2021 it was a little higher. The patient called her primary doctor. The patient took 800 mg Ibuprofen as treatment for fever of about 99.9. The outcome of started having trouble breathing and could not breath; breathing got worse and arm started hurting was not recovered and was unknown for the rest of the events. Information on the lot/batch number has been requested.
78 2021-04-27 pain in extremity left arm was sore; This is a spontaneous report from a contactable consumer (patient) via Medical In... Read more
left arm was sore; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810 and expiration date was not reported), intramuscular on arm left on 06Feb2021 at 11:00 as single dose for Preventative (COVID-19 immunization) in hospital. The patient medical history and concomitant medications were reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She did not administer additional vaccines on same date of suspect vaccine. No relevant tests were reported. It was reported that she got first shot of COVID vaccine on 06Feb2021 (Saturday). She was fine, she just had a sore in left arm Saturday night (06Feb2021). She was due to get the first shot on Tuesday 02Feb2021 but due to the snowstorm she had to get the shot on Saturday instead. The appointment for her second shot was scheduled for 23Feb2021, stated this was four days before the 21-day guidance and she inquired if this was ok. She stated that it was just like getting a flu shot, she occasionally got a sore arm for a couple of hours. She had been getting one for 24 years. She did not have the name or lot number for the flu shot she had received. She declined for any treatment of the event. She did not visit emergency room or physician office. The outcome of the event left arm was sore was resolved on 06Feb2021.
78 2021-04-27 pain in extremity Very sore arm by pm. Today 4/28/21 I am running temp 99 and now 100 via ear. Achy, chills, tired. I ... Read more
Very sore arm by pm. Today 4/28/21 I am running temp 99 and now 100 via ear. Achy, chills, tired. I had a colonoscopy done Monday 4/26/21 and did fine. Just want to stay in bed. Not yet feel need to call doc or be seen at ER.
78 2021-04-28 weakness Elevated troponin Essential Hypertension Abmulatory dysfunction Generalized weakness COVID-19 infect... Read more
Elevated troponin Essential Hypertension Abmulatory dysfunction Generalized weakness COVID-19 infection Hypomagnesemia
78 2021-04-28 facial pain hurting on right side of face, in and around R ear; hurting on right side of face, in and around R e... Read more
hurting on right side of face, in and around R ear; hurting on right side of face, in and around R ear; severe headache; nausea; vomiting; severe dizziness; All over body rash; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 08:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included high BP, hx of blood clots/CAD, covid-19 from 10Dec2020 to an unknown date. Concomitant medications included warfarin sodium (COUMADIN); and atorvastatin calcium (STATIN [ATORVASTATIN CALCIUM]); both taken for unspecified indications, start and stop dates were not reported. On 26Jan2021, 12:00 AM, 3 days later started hurting on right side of face, in and around R ear, severe headache/nausea/vomiting & severe dizziness. All over body rash occurred. 10 days later and lasted 3 weeks. The patient received treatment for the events: antibiotic/anti nausea/MRI/CT. The patient was hospitalized for five days for the events. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on an unspecified date, magnetic resonance imaging: unknown results on an unspecified date. The patient has not been COVID tested post vaccination. Information on the lot/batch number has been requested.
78 2021-05-02 weakness Patient experienced an arthritis flare after the 1st dose, and this became much more intense after t... Read more
Patient experienced an arthritis flare after the 1st dose, and this became much more intense after the 2nd dose. She had increased weakness, abdominal pain, loss of appetite (not eating/drinking much), falls, and failure to thrive x3 weeks after the second dose which all ultimately got her admitted to the hospital (4/6/21). Upon admission, her blood counts were found to be dangerously low.
78 2021-05-03 migraine Sore throat, swollen glands, teeth aching, migraines very painful
78 2021-05-03 tremor after vaccination, patient began to feel lightheaded and dizzy, experienced syncope. after waiting ... Read more
after vaccination, patient began to feel lightheaded and dizzy, experienced syncope. after waiting for about 15 minutes she began to complain about chest pain. We decided to call 911 as she was extremely agitated and tremors
78 2021-05-04 difficulty speaking Loss of voice; Asthma; her voice became extremely hoarse; This is a spontaneous report from a contac... Read more
Loss of voice; Asthma; her voice became extremely hoarse; This is a spontaneous report from a contactable nurse. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Mar2021 09:15 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunization. Family history included sore arm. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 (lot number: EN6198) on 23Feb2021 in the right arm for COVID-19 immunization. About 3-4 days after (as reported), her voice became extremely hoarse, in which she lost a voice for 3 weeks. She mentioned that she was diagnosed with Asthma on 23Mar2021 and was started with a Breo Ellipta inhaler. The Breo had a listed side effect of hoarseness of voice in which she started a week after receiving the vaccine, to which her hoarseness became worse. She mentioned that according to the paperwork she received from Pfizer, hoarseness of the voice was also listed as a side effect. She consulted with her Pulmonologist who determined that the inhaler was working pretty well and would like to continue her on it and wanted to see if the hoarseness is still there by May. As of calling, she already has some of her voice back, but the hoarseness was still continuing, which gets worse in the afternoon or evening. She would like to know if this has been reported and for how long it will last. She had the injection/vaccine and hoarseness started about a week before she started on the Breo Ellipta inhaler (NDC: 01730859-10 Lot: UL4F Expiration: 10/2022 Dose: 100mcg/25mcg). She stated they both can cause the same thing with hoarseness. She clarified that when she lost her voice, it was just above a whisper. It had gotten progressively worse since it started a week prior. It lasted almost 3 weeks. Now she has started to get her voice back, but still has the hoarseness and this was as good as her voice gets, it gets worse in the afternoon and by 2:00 P.M. it was back down to no voice. She went down to see the pulmonary specialist and prescribed her 2 different inhalers. The specialist said it was an unusual hoarseness, but he couldn't tell what one it was from. The patient clarified she experienced the hoarseness first from the Pfizer Covid Vaccine after the second vaccine, and then a week later she started on the Breo Ellipta, and the hoarseness got worse. The doctor wants to wait until 19May2021 and see if she still has the hoarseness and then he might switch, but it was working so well, he didn't want to switch her yet. The patient was prescribed Breo Ellipta and Albuterol but she hasn't used the Albuterol. The patient reported that she considers the event as medically significant because hoarseness can cause cancer and she doesn't want it to get worse. No other vaccines administered on the same date of the BNT162B2 and no prior vaccination. The event hoarseness started on 18Mar2021 and loss of voice on 23Mar2021. The events did not require a visit to the emergency room. The outcome of the event hoarseness was not recovered, Loss of voice recovered on 13Apr2021 and asthma was unknown. The events hoarseness and loss of voice was reported as serious-medically significant. Follow attempts are possible. Further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Hoarse voice and Loss of voice cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
78 2021-05-04 pain in extremity Pain; a lump down from where the injection site was/ lump in the arm, 4 inches down from the shoulde... Read more
Pain; a lump down from where the injection site was/ lump in the arm, 4 inches down from the shoulder where she got the shot; her shoulder aches; shoulder aches and the feeling goes into the arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 78-years, at single dose in left arm on 03Mar2021 10:00 (Lot number was not reported) for covid-19 immunisation. Medical history included type 2 diabetes that diagnosed about 3 years ago, this year makes 4 years, and she took medications for it. And she was a little overweight, supposed to drop some but gained some back that because of diabetes. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) also at age of 78-years, at single dose in left arm on 02Feb2021 13:00 for covid-19 immunisation and she had no problem with that one. Another Historical Vaccine included flu shots, it just lasted a day or two, maybe that's it, never had problems before. The patient's concomitant medications were not reported. The patient reported side effects from the Pfizer COVID vaccine. Her arm was still bothering her. There was a lump down from where the injection site was and that she kept rubbing it but it won't go away and that she still had pain. She was told she should go to the doctor, but she thought she would call to see what was best to do. She had not a fever, just the lump on the arm, 4 inches down from the shoulder where she got the shot. The patient stated that both Pfizer COVID vaccines were in her left arm, she should have gotten it in the other arm. The patient stated she heard about blood clots and thought she'd better check it out. The patient stated that she had the lump and her shoulder aches; not the shoulder the upper arm. The lump was on the inside and she kept rubbing it but it didn't go away. The patient had the second Pfizer COVID vaccine in the morning around 10:00 AM on 3Mar2021. The pain started the same day on 03Mar2021, then stated that night after midnight and that she thought it would go away. The lump in the arm started a couple of days after the Pfizer COVID vaccine, she thought it was a couple of days but maybe sooner, she didn't pay too much attention. The patient stated the lump felt like it was the size of a nickel, she was pushing to try to feel it and that maybe the lump was a little larger than a nickel. Her shoulder aches and the feeling went into the arm and it started the same week she had the shot but that she didn't pay any attention so is not sure exactly when it started. It was best to check it out with her doctor. The outcome for event pain and vaccination site lump was not recovered, while for remains event was unknown. Information on the lot/batch number has been requested.
78 2021-05-07 pain in extremity nurse was putting it in the wrong spot because it hurt so bad; pain in left arm; This is a spontaneo... Read more
nurse was putting it in the wrong spot because it hurt so bad; pain in left arm; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EM9809; Expiration Date: 30Jun2021), via an unspecified route of administration on Left arm on 07Feb2021 14:10 as 0.3 mL, single for COVID-19 immunisation. Medical history included rotator cuff surgery from 2013; Back problems, had brain surgery when she was 39 and she still has ongoing disability from that. Patient stated that born with the disability in her right hand and a cyst, they just didn't find the cyst until she was 39 and that's when she had the surgery. Family history was reported as none. The patient's concomitant medication was unspecified allergy shots, once a week and ongoing. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1283, Expiry date: 30Apr2021) on 17Jan2021 for COVID-19 immunisation. It was reported that, the patient has gotten both shots and she didn't have any problems with the medication, but she had a problem with the 2nd shot, so she was calling for advice. States that she got her 2nd shot on Sunday, and the nurse either stuck it into a nerve or into the muscle because she felt like her arm was going to fall off before the nurse even pushed in the medicine; states that she wanted to scream. Now she was still having pain in that arm, but it's not exactly where the shot was, it's running down her arm and it's not constant, it comes and goes. States that she did have rotator cuff surgery in 2013, and that's kind of what the pain feels like now. This is in her left arm, which was the only arm that she can really use, because she had brain surgery when she was 39 and she still has a disability from that. Clarifies that she was born with the disability with her right hand and a cyst, they just didn't find the cyst until she was 39 and that's when she had the surgery. States that it scares her because she only has the use of one arm already. She had no problem with the medication in the vaccine either time. States that the second time she got the vaccine, she knew that the nurse was putting it in the wrong spot because it hurt so bad, like so bad that she wanted to slap her. States that the pain is nowhere near like it was on Monday, but she didn't know who to call. She gives herself allergy shots, so she knows how to give herself injections. States that the vaccine was perfect, she had no side effects from that. The first shot, she didn't even know that she had gotten a shot. States that yesterday her arm didn't feel as bad as it does today. It's more aggravating. Again, states that the pain was like what she had after her rotator cuff surgery. States that she hasn't felt that pain since her surgery, then on Sunday when she got the shot the pain has kind of started back up. States that it has definitely improved. On Monday and Tuesday, she would feel a little twinge of pain about every 3-4 hours, but today it's every 10-15 minutes. The patient not visited emergency room and not visited physician office. The outcome of the event pain in left arm was recovering and was unknown for another event.
78 2021-05-10 weakness muscle and joint aches; muscle and joint aches; teeth and bones hurt; teeth and bones hurt; chills; ... Read more
muscle and joint aches; muscle and joint aches; teeth and bones hurt; teeth and bones hurt; chills; weakness; I can hardly walk right now; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via unspecified route of administration on an unspecified date (4 weeks and 2 days after the first dose) (at the age of 78-year) as single dose for COVID-19 immunization. The patient medical history included lumber stenosis. The patient concomitant medications were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on unspecified date as single dose for COVID-19 immunization. On an unspecified date, patient felt awful with muscle and joint aches, teeth and bones hurt, chills, weakness. She stated that she could hardly walk right now and could not get over to her primary care physician. The patient informed that she received a steroid injection of some kind on her back for lumbar stenosis 2 weeks and 2 days after the first dose of the vaccine. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
78 2021-05-10 face paralysis Non-ST elevation (NSTEMI) myocardial infarction Facial weakness NSTEMI (non-ST elevated myocardial i... Read more
Non-ST elevation (NSTEMI) myocardial infarction Facial weakness NSTEMI (non-ST elevated myocardial infarction) CHEST PAIN CEREBROVASCULAR ACCIDENT
78 2021-05-10 tenderness, weakness intestinal problems after she eats, and feels like intestinal flu; Balance is off; feeling unwell, j... Read more
intestinal problems after she eats, and feels like intestinal flu; Balance is off; feeling unwell, just didn't feel good/just hasn't felt right; bursitis in her hands./both of her arms that felt like bursitis; feeling weak, her legs, she could barely stand she had to go to bed; feeling weak, her legs, she could barely stand she had to go to bed; problems with her stomach, intestinal things, intestinal problems; problems with her stomach, intestinal things, intestinal problems further described as lower intestinal; joint pain/shoulders, knees and wrists hurt; Muscle pain; Tenderness; fever; weak; tired; Left arm hurt, injection site pain/tenderness at the injection site; This is a spontaneous report from a contactable consumer (patient) A 78-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 13:37 (Batch/Lot Number: EW0150; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunization. The facility in which the vaccine was given was . Medical history included ongoing arthritis (If she does much your arms will ache/Doesn't take anything for her arthritis, her fingers and joints), hypersensitivity from an unknown date and unknown if ongoing allergy to milk , urticaria from an unknown date and unknown if ongoing (When she gets stressed she gets hives if she does not take her liquid Benadryl she will swell up) , covid-19 from Nov2020 to an unknown date Sick for 3 weeks/intestinal flu, diarrhea, couldn't eat anything/ test oxygen level; knuckles are so big it was registering like 76. Patient's doctor recommended the vaccine since she had Covid virus in Nov2020. Concomitant medication(s) included takes cholesterol and thyroid medication (details not provided); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication from an unspecified start date and ongoing; calcium (CALCIUM) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took influenza vaccine and experienced influenza, Previously took Aspirin and experienced angioedema. The patient experienced left arm hurt, injection site pain/tenderness at the injection site on 05Apr2021, fever, weak on 06Apr2021, weak, tired on 06Apr2021; joint pain/shoulders, knees and wrists hurt, muscle pain, tenderness on 08Apr2021, problems with her stomach, intestinal things, intestinal problems on 12Apr2021, intestinal problems after she eats, and feels like intestinal flu, balance is off, feeling unwell, just didn't feel good/just hasn't felt right,bursitis in her hands./both of her arms that felt like bursitis, feeling weak, her legs, she could barely stand she had to go to bed on an unspecified date. The adverse events did not require a visit to the Emergency Room or Physician's Office. The patient underwent lab tests and procedures which included body temperature: '100.57 ' fahrenheit on 06Apr2021. Clinical course was reported as follows the patient received the first Pfizer-BioNTech Covid-19 Vaccine on 05Apr2021. On the same day 05Apr2021 her left arm hurt, injection site pain. On 06Apr2021 in the afternoon she had a fever of 100.57 Fahrenheit. She was also very weak and had to lay down because she was tired. She had site pain, joint pain, and muscle pain. With the joint pain her wrists hurt, it was her shoulders, knees and wrists hurt. The tenderness at the site didn't go away until Sunday. She reported her problems with her stomach, intestinal things, intestinal problems, further described as lower intestinal. She started feeling weak, her legs, she could barely stand she had to go to bed. She was tired, started to get joint pain and feeling unwell, just didn't feel good. She felt that just to stand she would fall down, so she had to lie down. Her balance is off, and she felt weak for about 2-3 days, weak is not completely gone but noticed her balance is off a little bit which is ongoing. She just hasn't felt right since she's had the shot. With the muscle pain it felt like she had bursitis in her hands. She had tenderness at the injection site as well as in both of her arms that felt like bursitis, which went away on 12Apr2021 or 13Apr2021. She has intestinal problems after she eats, and feels like intestinal flu. Someone saw her and said she looks tired. On 7Apr2021, she had a visit from the the insurance company doctor and he recommended her not to take the second shot, and that's why she called Pfizer. The second dose of Pfizer-BioNTech Covid-19 Vaccine is due on 26Apr2021 but she's not sure she wants to because she is still recovering from the first one. The clinical outcome of the events Joint Pain, Muscle pain recovered on 12Apr2021, Vaccination site pin Recovered 10Apr2021, Fever recovered 06Apr2021, Weak, tired, balance is off, feeling unwell, just didn't feel good, intestinal problems after she eats, and feels like intestinal flu was unknown, Tenderness was recovered Apr2021, problems with her stomach, intestinal things, intestinal problems was not recovered
78 2021-05-11 tremor harder to breathe; smell of food made me sick later that day; blood pressure went down; cold chills;... Read more
harder to breathe; smell of food made me sick later that day; blood pressure went down; cold chills; Shaking; This is a spontaneous report from a contactable consumer (patient reported for herself). A 78-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982) administered in left arm via an unspecified route of administration on 27Feb2021 at 10:00AM as SINGLE DOSE for covid-19 immunization. Medical history included arthritis, known allergies to sulfa and Tetanus shots. The patient's concomitant medications were not reported. The patient previously took first dose of historical vaccine of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported) via an unspecified route of administration on 06Feb2021 at 10:00 am as SINGLE DOSE for covid-19 immunization and experienced no adverse event. Other historical vaccine in 4 weeks included Prolia on 21Jan2021 in doctor office. On 28Feb2021 at 12:30 am, the patient was harder to breathe, smell of food made me sick later that day, blood pressure went down, cold chills and shaking. The patient reported as Shaking was so hard as she could not hold glass of water or get the pills out of the bottle because they flew all over the place. This lasted for 2 hours. Then smell of food made the patient sick later that day and then with the cold chills. It took heating pad and other heating products to stop from shaking. patient blood pressure went down to 98/60 and harder to breathe for just a short time. Treatment received for the event shaking and no treatment received for other events. The outcome of the events was recovering. No follow up attempts were possible. No further information was expected.
78 2021-05-14 burning sensation A severe irritation, burning and itching all over legs and arms. It was like a sun poisioning or sev... Read more
A severe irritation, burning and itching all over legs and arms. It was like a sun poisioning or severe sunburn. Dermatologist treated me with a steroid shot and betamethasone cream. Followed up with dermatologist a week later and it had improved but was not fully healed.
78 2021-05-14 pain in extremity Severe pain in both legs from the back of my knees down to my ankles. Lasted about 3 days. The secon... Read more
Severe pain in both legs from the back of my knees down to my ankles. Lasted about 3 days. The second day I could barely walk at all. Same happened after second injection but pain was not quite as severe. Pain lasted about 4 days.
78 2021-05-16 nerve pain 2 1/2 hours after receiving 2nd shot, I developed total stiffness in back could barely stand up stra... Read more
2 1/2 hours after receiving 2nd shot, I developed total stiffness in back could barely stand up straight and had a stabbing, electric nerve pain down the L leg that was causing me to walk with a cane and take pain pills. I am still with pain, can walk only short distances and feel fatigue and L leg shakes . My gait is unsteady.
78 2021-05-24 slurring Slurred speech, disoriented
78 2021-05-24 numbness, muscle spasms The patient called in around 1:00 pm on 5/25/21 to report symptoms after vaccine. She said that she ... Read more
The patient called in around 1:00 pm on 5/25/21 to report symptoms after vaccine. She said that she had pain in the right side of neck and in the back of the head and felt dizzy after the 15 minute wait when she stood up to leave after receiving her vaccine. She said that she felt tired later and slept well all nigh. At 6 am she said that she had cramps in calves, legs, and arms. At 9:30 am she woke up and felt tired and had a strange sensation in the back of the neck and numbness in the mouth and jaw. She said she is feeling a little better now.
78 2021-05-24 muscle spasms 1 week later - aches (arthritis was worse), leg cramping, general feeling of being unwell seems to c... Read more
1 week later - aches (arthritis was worse), leg cramping, general feeling of being unwell seems to come and go still having pain in arm where injection was
78 2021-05-25 numbness, pain in extremity back was so stiff; extremely difficult to stand; When I was in a standing position, an Electric bolt... Read more
back was so stiff; extremely difficult to stand; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; so dizzy I could not stand up; no appetite; brain fog; I shuffle very short distances and very slowly trying to avoid a fall.; toes and bottoms of feet were also totally numb; This is a spontaneous report from a contactable other health professional (patient). A 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration, in the right arm, on 15Mar2021 08:45 (lot number: EN 6207), at the age of 78, at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was at the hospital. Patient medical history was not reported. Concomitant medications included losartan, hydrochlorothiazid and fexofenadine hydrochloride (ALLEGRA) for unspecified indications. The patient previously received first dose of bnt162b2 via unspecified route of administration, in the right arm, on 23Feb2021 14:30 (02:30 pm) (lot number: EN 5318) for COVID-19 immunization. On 15Mar2021 11:15, exactly 2 and a half hours after receiving the second dose of vaccine, patient tried to stand up but experienced back was so stiff; it was extremely difficult to stand. When patient was in a standing position, an electric bolt of pain shot in her left groin and down the right of her left thigh and into her left knee on down inside the left calf, left ankle and left toe; all on 15Mar2021 11:15. The pain has been constant and the most horrible pain she have ever suffered, as reported. It was reported that patient have never had this type of episode before in her life, which causes her to believe it has been a side effect of the 2nd dose of the vaccine. The pain continues to this day, at the time of reporting. Patient also experienced being so dizzy, she could not stand up; no appetite and brain fog on 15Mar2021 11:15. Before the shot, patient reported she can walk 50 blocks daily for the past 10 years. After 15Mar2021 (on unspecified date in Mar2021) she shuffles very short distances and very slowly trying to avoid a fall. Her toes and bottoms of feet were also totally numb when she wakes up each morning, since unspecified date in Mar2021. Treatment was received for the events (unspecified medications) on 28Apr2021 and physical therapy. Patient went off the medications the doctors gave her on 28Apr2021, choosing to tolerate the pain. The pain to this day, somewhat diminished. The events resulted to a Doctor or other healthcare professional office/clinic visit. Events were assessed as serious, disability. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the events, musculoskeletal pain, dyssastia, groin pain, pain in extremity, arthralgia, postural dizziness, hypoesthesia, feeling abnormal cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.
78 2021-05-31 weakness Flu like symptoms; Weakness; Headache; Tiredness; just sleeping /. She slept it off for a couple of ... Read more
Flu like symptoms; Weakness; Headache; Tiredness; just sleeping /. She slept it off for a couple of days./felt very sleepy; she could feel her heart racing; had a heavy feeling on her head; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date were unknown), via an unspecified route of administration on 26Jan2021 10:00 (at the age of 78-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included asthma and chronic obstructive pulmonary disease from an unspecified date, diagnosed many years ago. Broken collarbone and Broken wrist on 28Dec2020. It was reported that she had three broken bones in her wrist, she can't lay in bed anyway, so she sleeps on the sofa, getting constipated on an unspecified date, The patient was allergic to Benadryl. It was also reported that she doesn't sleep too well, due to the sitting up in the chair business. concomitant medications were not reported. On 26Jan2021, 2-3 hours after, she felt very sleepy, had a heavy feeling on her head that was almost flu-ish but had no fever nor chills, and she felt that her heart was racing Influenza like illness, weakness, headache, and tiredness. She slept it off for a couple of days. She was enquired if she can still take the 2nd dose of the vaccine given these side effects. It was reported that she had her first dose of the shot on the 26th of Jan and thinks she had a reaction, though it was not enough to go to her doctor or anything, she was too weak. She said she didn't have chills, was not nauseous, had no fever, she feels like she had the flu, and. She said that she gets up and eats then goes back to sleep or does whatever else she had to do. she can't lay in bed anyway so she sleeps on the sofa. she did get up the next day and all the time had a headache. She says she doesn't take the flu shot because her older brother had a terrible reaction to that, none of her siblings take that shot, but she knows what it feels like to have a bad cold with your head heavy, that kind of feeling, she imagines that is what the flu feels like. The patient received treatment with Tylenol for headache. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): 110/70 mmHg on an unspecified date, blood test: unknown on an unspecified date, Pulse (heart rate): pulse was ok on an unspecified date. Caller said that she was so surprised when she went to her doctor's appointment that her heart was racing, and she thought her blood pressure would be sky high, but the bottom number was 70 something, which is low for her, and the top number was 110, so it was perfect, which she doesn't usually have. She said that her pulse was ok and everything else was ok, and she had blood work taken that day but they didn't get those results back yet, so she doesn't know what they are. The outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up (13May2021): Follow-up attempts completed. No further information expected.
78 2021-05-31 weakness I had the vaccine and three hours I was on a walk and I had to turn around half a mile and come back... Read more
I had the vaccine and three hours I was on a walk and I had to turn around half a mile and come back home and I had extreme fatigued for a whole month and my husband would have to wake me up three times a day to feed me, I have severe head aches, my kidney level functioning drop to above 50, then the second month I would sleep 3 3 hour nap for the day, I could not get my stamina back. I went about 2 days later to the doctor. She did some blood tests, I have had 4 of them, and all of them have been fine. Now is month 4 and I am slowly recovering, my heart doctor gave me Colchicine and I have been on that for 5 days. I have to get up 7 times in the night to go to the bathroom for diarrhea. In the 29th of June I will have an ECHO cardiogram.
78 2021-05-31 pain in extremity Her arm of course was aching, Sore arm; This is a spontaneous report received from a contactable con... Read more
Her arm of course was aching, Sore arm; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient reported A 78-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in upper left arm on 01Feb2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 01Feb2021, the patient experienced her arm was aching. The patient reported that she received the first dose of the Pfizer vaccine on 01Feb2021, but patient was questioning how many don't have any issues and no symptoms. Reporter stated, she thinks it was normal. It's not going to be effective, she was expecting something, That's kind a good. The patient had a sore arm on the first day, and it subsided, it went away. it's a tiny sore. The patient was a little concerned because she did not have a reaction, that tend to worry. she was not experienced any symptoms except for her arm of course was aching, it was gone away now, is it still effective if there are no symptoms. The patient clarified her arm aching is very slight now. The outcome of the event was resolving. Information about Lot and Batch has been requested. Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
78 2021-06-01 pain in extremity, weakness Patient said shot hurt badly, arm was sore but felt better after 15 minute observation time. Patient... Read more
Patient said shot hurt badly, arm was sore but felt better after 15 minute observation time. Patient was able to grocery shop after and felt fine. She started to feel bad later in the day and went to bed around 8PM. Patient says she could not sleep, dozed on and off and had chills and sweats. When she woke up at 5:30AM, she said her legs felt like they had been crushed, she was in extreme pain and her legs felt paralyzed and she could not move them an inch. She had to use her arms to move her legs. She states it took her an hour to get to a chair. She sat in the chair for 45 minutes and was then able to gradually prop herself up to a dresser and eventually made it to her bathroom. Her condition gradually improved over time and she was able to walk much better on 5/29, Today she reports no leg pain, but reduced energy levels.
78 2021-06-03 feeling hot, tremor Shaky; Warm; My face turned red; My hands were shaking; I felt my heart skipping with irregular hear... Read more
Shaky; Warm; My face turned red; My hands were shaking; I felt my heart skipping with irregular heart beats; The nurse measured my blood pressure and it was 183/95 with a pulse of 104; This is a Spontaneous report from a Contactable Consumer (patient, self-reported). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Feb2021 at 08:30 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included hypertension, chronic lymphocytic leukemia, osteoporosis, glaucoma and known allergies: reaction to epinephrine (cannot have Novocain with epinephrine), reaction to histamines and tyramine. Concomitant medications included metoprolol succinate (TOPROL XL), Amlodipine, Levothyroxine, and Atorvastatin. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 03Feb2021, about 7-10 minutes after receiving the shot, she started to feel extremely shaky and warm. Her face turned red, and her hands were shaking. She felt her heart skipping with irregular heartbeats. The nurse measured her blood pressure, and it was 183/95 with a pulse of 104. She was observed for an hour. The patient did not receive treatment for the events. Outcome of the events was recovered on an unknown date in Feb2021. Follow-up attempts completed. No further information expected.
78 2021-06-04 burning sensation her tongue felt burned; her mouth was burning; her throat was burning; acid reflux; everything was s... Read more
her tongue felt burned; her mouth was burning; her throat was burning; acid reflux; everything was still burning; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Feb2021 (at the age of 78-years-old) (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included macular degeneration. The patient's concomitant medications were not reported. Historical vaccine included tetanus vaccine on an unspecified date for immunisation. She got her first dose of the Pfizer Covid 19 vaccine on 25Feb2021 and thought she was having a reaction. She called her doctor and he said go get some Benadryl to make sure your throat doesn't get swollen. She went out and bought Benadryl and she took the Benadryl every six hours. Her doctor said don't get the second dose of the Covid 19 vaccine because these side effects she had are a warning and the second dose might not be helpful for her. The patient reported that she stayed at the facility that gave her the Covid 19 vaccine for 20 minutes and her husband was waiting for her. When she was driving away from the facility her tongue felt burned and then her mouth was burning and then her throat was burning on an unspecified date. She does have acid reflux but this wasn't like any acid reflux she's ever had. She got home and she drank some cool water but everything was still burning. By then it was almost supper time so she took 20 mg of Pepcid. Her mouth burned throughout her meal. She called her doctor again and he asked her if her mouth was swollen and she told him she didn't know. She took more Benadryl. One of her daughter's told her that the Covid 19 virus was so bad that she should get her second dose of the Covid 19 vaccine no matter how bad her reaction was. Her doctor told her not to get the second Covid 19 vaccine. She assumed it was a done deal. She wasn't going to get the second dose. She was supposed to get her second dose on 17Mar2021. She had gone to the doctor a couple times and each time he told her, do not get the second Covid 19 vaccine. He showed her the Pfizer Covid 19 vaccine print out with side effects. When her mouth started burning after she got the first Covid 19 vaccine her husband did ask her if she wanted to turn around and go back to the facility where she got the vaccine but she told him no. Now she's missed her second Covid 19 vaccine on 17Mar2021 because she thought that what her doctor told her was the final word. She was afraid to get the second Covid 19 vaccine and she wants to listen to her doctor because he knows what's best. During this Covid 19 virus time she was also diagnosed with Macular Degeneration. That's keeping her from driving and she's lost even more of her independence. She's heard if she gets the Covid 19 virus it can attack her eyes. Every time she hears the words fully vaccinated it makes her want to cry. She's worried that people won't want to be near her because she's not fully vaccinated. Her husband had both of his Covid 19 vaccines and he had no side effects. Her husband gets every vaccine on the market and never has any side effects. As far as she's concerned she feels like a pariah because no one will want to be around her because she's not fully vaccinated. Therapeutic measures were taken as a result of all events. The outcome of the events was unknown. Information about lot/batch number has been requested. Follow-up (02Jun2021): No follow-up attempts are completed; information about lot/batch number cannot be obtained.
78 2021-06-08 pain in extremity Blood pressure high; her doctor could see that she had some pneumonia showing; Coughing; soreness in... Read more
Blood pressure high; her doctor could see that she had some pneumonia showing; Coughing; soreness in her arm; slept all day long; started running a 99.9 temperature; could not catch her breath, her breathing was down in the danger zone at 220; This is a spontaneous report from a contactable consumer (Patient). A 79-year-old elderly female patient received bnt162b2 (COMIRANTY; Solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration on 11Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date the patient experienced, the patient could not catch her breath, her breathing was down in the danger zone at 220 reported dyspnoea and hospitalization on an unspecified date, had high blood pressure, her doctor could see that she had some pneumonia showing, coughing, soreness in her arm, slept all day long. Additional Context: Consumer states that her doctor wanted her to call and report this, because she has asthma and allergies that are chronic. Consumer states that she took her first Pfizer injection in April. She saw her allergy specialist on the 1st, and she tested the Consumer before she took the vaccine. She states that her breathing was at 113% breathing capacity (good) and the allergy specialist wanted her to go ahead and get the injection, which the Consumer did. Consumer clarifies that she received the first Pfizer COVID vaccine on 11Apr2021 and that she did really good with that one. Consumer then received the second COVID vaccine on 13May2021. She came home and slept almost all night long and thought she was okay. The Consumer explains she was not feeling real good before she went to receive her second dose. It was kind of like she was having some coughing and stuff, but she thought it was not bad and that she could still go ahead and get it. She went ahead on 13May2021 and had the second dose. Consumer states that on the first day, she slept all day long- the whole entire day, she didn't even wake up. On the second day, the Consumer states that she had soreness in her arm. Then, she noticed she was getting really sick and started running a 99.9 temperature. It was getting worse day by day, and she kept coughing and getting worse. Then, on 18May2021, her husband took her to the emergency room and they just automatically treated her for asthma and allergy and sent her home. This was on Tuesday night. On Thursday night, she got so bad that her breathing was down in the danger zone at 220. She couldn't breathe. Her husband rushed her back to the ER and this time, they kept the Consumer and hospitalized her for a week. Her blood pressure was high. She clarifies normally her breathing on her peak flow meter, she can always do from 350-400. Well on Thursday night, her peak flow was all the way down to 220 and she could not catch her breath. Consumer states that she was admitted to the hospital and they had her on oxygen and blood pressure medication. She states that they did a bronch on her and still did not really come to a conclusion of what was happening. She was told it looked like it could be an infection in her lungs. Consumer states that she is having to see three doctors this week because of this since she got out of the hospital. She saw her medical doctor, Dr., yesterday who was very concerned because she had a recent patient that was about the same age as the Consumer- he was 75 years old. This patient had done the same thing, only he ended up taking pneumonia and dying with it. The doctor told the Consumer in her x-ray, her doctor could see that she had some pneumonia showing. The Consumer asked her doctor while she was in the hospital about the pneumonia and they refused to listen to anything the Consumer said, so Dr. told her that the Consumer needed to report this because she is still so sick. Consumer clarifies that she was hospitalized for a week and that she just got out on Saturday, 29May2021. While reporting the event details, the Consumer stated that she had and emergency call coming through and that she had to take it. Consumer had to end the call, stating she had to go and requested this call handler call her back. The patient was hospitalized due to events. The patient underwent lab tests and procedures which included blood pressure measurement, body temperature: 99.9, peak expiratory flow rate: 220 Units: x-ray: had pneumonia showing. The outcome of the events was unknown.
78 2021-06-09 pain in extremity erythematous, mildly itchy confluent macular rash near injection site; erythematous, mildly itchy co... Read more
erythematous, mildly itchy confluent macular rash near injection site; erythematous, mildly itchy confluent macular rash near injection site; erythematous, mildly itchy confluent macular rash near injection site; After second dose, had initial mildly sore arm for two days.; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN6202), via an unspecified route of administration, in left arm on 01Mar2021 11:30 (at the age of 78-year-old) as second dose single, for COVID-19 immunization. Medical history included osteoporosis, bladder cancer, status post radical cystectomy with ileal conduit diversion in Nov2020. The patient had no known allergies. Concomitant medication(s) included alendronate sodium (ALENDRONATE SODIUM) and others. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EM9810), via an unspecified route of administration, in left arm on 08Feb2021 at 11:15 AM (at the age of 78-year-old) as first dose single, for COVID-19 immunization and only had mildly sore arm. The vaccine was administered at Doctor's office/urgent care. No other vaccine was administered in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. On 03Mar2021 after second dose, had initial mildly sore arm for two days. Two days later on 05Mar2021 noted erythematous, mildly itchy confluent macular rash near injection site. Has persisted to present, but appears to be fading. No other side effects noted. No treatment was given for the events. The events had not resolved. No follow-up attempts are possible. No further information is expected.
78 2021-06-09 tingling Tingling in arms and legs; red, swollen ear lobe; rosacea; This is a spontaneous report from a conta... Read more
Tingling in arms and legs; red, swollen ear lobe; rosacea; This is a spontaneous report from a contactable consumer (Patient). A 78-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN620U), dose 1 via an unspecified route of administration, in left arm on 04Mar2021 11:30 (at the age of 78-year-old) as 1st dose, single dose for covid-19 immunisation. Facility type reported hospital. Medical history included breast cancer. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Known allergies reported to dairy, gluten. Concomitant medications included levothyroxine sodium (SYNTHROID), monascus purpureus (RED YEAST RICE), probiotics, vitamin D [vitamin D nos]. The patient did not receive any vaccines within four weeks prior to the vaccination. On 04Mar2021 at 15:00, the patient experienced tingling in arms and legs, red, swollen ear lobe and rosacea. The patient received treatment of benadryl for events. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
78 2021-06-10 feeling cold She felt 'weird'.; she noticed a cooling effect at the bottom of her ribcage; This is a spontaneous ... Read more
She felt 'weird'.; she noticed a cooling effect at the bottom of her ribcage; This is a spontaneous report received from a contactable female consumer (Patient) and a contactable consumer (husband). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Mar2021 15:50 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for hypothyroidism from an unspecified start date and ongoing and multivitamins. The patient experienced she felt 'weird'. (feeling abnormal) (non-serious) on an unspecified date with outcome of unknown, she noticed a cooling effect at the bottom of her ribcage (feeling cold) (non-serious) on 09Mar2021 with outcome of not recovered. Follow-up attempts completed. No further information expected.
78 2021-06-10 pain in extremity Pain and stiffness in hands. Pain and stiffness all the time.
78 2021-06-13 numbness left side of mouth and 3 fingers of left hand went numb. no drooping of face
78 2021-06-14 pain in extremity Left arm was sore when received the vaccine which she expected. Then it started traveling and now i... Read more
Left arm was sore when received the vaccine which she expected. Then it started traveling and now it is completely up to the shoulder area and she is in extreme pain. Her doctor told her to call local DOH to report adverse effects.
78 2021-06-14 pain in extremity I woke up the next morning with a very soar arm, a fever, chills and so achy. The next day, the fev... Read more
I woke up the next morning with a very soar arm, a fever, chills and so achy. The next day, the fever and chills were gone, but I felt worse. Very weak, my legs felt as though they couldn't hold me up. I was so exhausted. I am still having issues. I thought I was feeling better, I thought, but I am still experiencing the issue with the weak legs, being so tired. I also feel light headed lately. I did see my family doctor 2x and spoke with him on the phone a couple times. He did blood work, all came back good.
78 2021-06-16 burning sensation This is a spontaneous report from a contactable consumer reported (herself). A 78-year-old female pa... Read more
This is a spontaneous report from a contactable consumer reported (herself). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration in left arm 28Apr2021 16:15 (at age of 78-years-old) as 1st dose, single dose for COVID-19 Immunization. Patient medical history includes ongoing blood pressure, ongoing (Gastroesophageal reflux disease) GERD reflux, ongoing back pain. Patient had allergies to things like hay fever, pollen, dust, mold. Historical vaccine include Shingles shot on unspecified date and experienced flu. If she had the booster, she would not have shingles. Patient past drug includes Zantac for about 6-8 months ago. Other conditions include scoliosis, has had back operations. She has lost a lot of height due to scoliosis. Patient concomitant medications include irbesartan used for prevention of high blood pressure from unspecified date and ongoing, metformin hydrochloride (METFORMIN ALPHARMA) (1000 mg, 1x/day frequency) used for preventative for Diabetes, she does not have Diabetes from unknown date and ongoing, Famotidine (20mg) taken for GERD reflux from 6 to 8 months from unspecified date, Vitamins taken from unspecified date and unknown till ongoing. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On Apr2021, Patient experienced shingles, pain in her back, rash on lower back which are ongoing and does not feel great, itching or burning in her back was worse. She is unsure if it started the day before or the day of the vaccine. Patient received treatment for events by Mederol/ Methylprednisolone 4 mg for pain as prescribed by the doctor only taken for 1 day/ 6 pills. Also took an Advil the day before and the night of the shot. Patient didn't visit any emergency room but just called her physician. she had a rash on back which doctor confirmed was shingles. The patient had a side effect after the first dose of the vaccine. She asked should I get the second dose. The patient wanted to know if it is accurate that she can delay the 2nd dose up to 6 weeks. She is supposed to get her second dose of Pfizer Covid Vaccine this coming Wednesday, 19May2021, but she still has shingles and does not feel great. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. In response to caller, they suggested to consult healthcare provider they know your health situation and has access to information that can better help inform this decision. Second Pfizer Covid Vaccine shot, she said it is scary, and the doctor said it was scary for her not to take it, all. The Outcome of events was recovering. Follow up attempts are needed. Further information has been requested.
78 2021-06-16 pain in extremity Swelling, pain and weakness in right arm. The symptoms were diagnosed as lymphedema. Treatment consi... Read more
Swelling, pain and weakness in right arm. The symptoms were diagnosed as lymphedema. Treatment consisted of 2 weeks of antibiotics and steroids and, eventually PT with a specialist in lymphedema swelling. This side of the patient has many of her lymph nodes removed in conjunction with a surgical removal of a right breast cancer lump removal some 25 years ago. No lymphedema symptoms had ever incurred in the patient prior to the covid vaccination. PT is ongoing but little improvement after 2 weeks of treatment.
78 2021-06-16 pain in extremity Sore arm after first dose; This is a spontaneous report from a contactable other hcp (patient, retir... Read more
Sore arm after first dose; This is a spontaneous report from a contactable other hcp (patient, retired registered nurse). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL9264, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 04Feb2021 13:00 as 1st dose, single dose for covid-19 immunisation. The patient medical history included diabetes mellitus, hypertension. Concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. It was reported that, on 4Feb2021 patient had her first vaccine and had no symptoms of a reaction. She had a sore arm after first dose for a couple days from 4Feb2021 to 6 Feb 2021. Patient took Pfizer Covid-19 vaccine to prevent the disease. Relatedness for event sore arm after first dose was related. The patient underwent lab tests and procedures which included ultrasound scan: numerous blood clots below the knee on 04Apr2021. Seriousness for sore arm after first dose was reported as not serious. The outcome of the event was recovered. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021499940 same patient/drug, diff dose/event
78 2021-06-18 breast pain, pain in extremity Pain in the shoulder; Hurt when I take a deep breath (lasted for days), pain radiated around my brea... Read more
Pain in the shoulder; Hurt when I take a deep breath (lasted for days), pain radiated around my breast in the front.; Hurt when I take a deep breath (lasted for days), pain radiated around my breast in the front.; The "pain in the hip and there was also pain in the big toe- 'in the very core of toes' and next 2 toes/foot pain; And arms hurting/arm was really sore; She was sleepy tired; She was sleepy tired; Had tingling on the lips; A sore on my tongue; Felt like I got stabbed in the butt/hip and butt was hurting; Hip joint was hurting; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was reported as FW0179 or EW0179, Expiry Date and NDC number are unknown), via an unspecified route of administration, administered in Left deltoid on 27May2021 at the age of 78-years-old as 1st dose, single dose for covid-19 immunisation. Medical history included asthma, osteoarthritis, hypertension from an unspecified date. It was reported that patient has food allergies, drug allergies, and environmental allergies. The patient had tingling on the lips and stated that she had experienced this before when she gets exposed to chemicals with a very strong aroma that her body didn't like. Concomitant medications included losartan (LOSARTAN), hydrochlorothiazide (HYDROCHLORZIDE), simvastatin (SIMVASTATIN), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for unspecified indication, on unspecified date. The Caller reported having possible side effects after the first dose. She said that she has a lot of allergies and was asked to stay for 30 minutes and nothing happened. She went home (10 minutes from site), and she had tingling on the lips, right away on 27May2021. She stated that she had experienced this before when she gets exposed to chemicals with a very strong aroma that her body did not like. she knows that is an allergic reaction. She also reported a sore on her tongue (not sure if from vaccine), felt like I got stabbed in the butt, hip joint was hurting on 27May2021, and arms hurting. The next day on 28May2021, she stated that her arm was really sore and that she was sleepy tired. Her arm hurt and she had pain all day and was sleepy. The caller knows that being sleepy and the pain in the arm is normal. On the third day, 29May2021, she said that the pain in the hip and there was also pain in her big toe- 'in the very core of toes' and the two toes next to it. The next day on 30May2021, she didn't feel the toe pains but still felt sleepy and tired. That Wednesday, 02Jun2021, she had pain in her shoulder when she took in a deep breath. This went on so the caller went to the doctor and had an x-ray on Thursday. She was prompted to consult because of "pain in the shoulder" she said it hurt when she takes a deep breath (lasted for days), pain radiated around my breast in the front. Her shoulder wasn't hurting that bad, but it was still there until Friday. The pain was in her shoulder blade and it went to the front near her breast. She went to the chiropractor on friday, and he said he thought it was from the vaccine. Upon checking up with Doctor with an x-ray, Doctor confirmed that he couldn't see anything; nothing to indicate pericarditis. In addition to this, she mentioned that the nurse practitioner also experienced the toe pains (Age and Gender not provided). On the next day on 03Jun2021, she set an appointment with her chiropractor, and confirmed these side effects were from the vaccine. It was reported that age at time of onset of reaction/event was 78. Does the caller wait to a take the vaccine. Does the caller not even take the second dose. Her hip hurting was like a jab. Her foot pain woke her up in the middle of the night. She received her first dose on 27May2021. She was scheduled for her second dose on 16Jun2021. She was worried and has her reservations about getting the second dose because she had a reaction. She asked if it would make a difference to wait for getting the second shot; "is it better if I wait between vaccine one and two" She has heard that people get adverse events after the second dose. The patient underwent lab tests and procedures which included chest x-ray: normal on the same week that she received the shot on an unspecified date in 2021, the nurse practitioner said the chest x-ray was unremarkable and x-ray: normal on an unspecified date in 2021. Reporter seriousness for events was unspecified. The outcome of the event had tingling on the lips was recovered on an unspecified date in 2021 and for Felt like I got stabbed in the butt/hip and butt was hurting, Hip joint was hurting, arms hurting/arm was really sore was not recovered while for other events was unknown.
78 2021-06-18 pain in extremity Flu like symptoms; Headache; Aches and pains; Sore arm; lower lip broke out with cold sores; This is... Read more
Flu like symptoms; Headache; Aches and pains; Sore arm; lower lip broke out with cold sores; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0186, Expiration date and NDC number are unknown, time the vaccination was given: Noon), via an unspecified route of administration, administered in Left arm on 03Jun2021 at the age of 78-years-old as 2nd dose, single dose for covid-19 immunisation. The patient s medical history including any illness at time of vaccination were osteopenia, osteoarthritis and fibromyalgia, diagnosed over 20 years ago in 2001. The patient s concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0186, Expiration date and NDC number are unknown), via an unspecified route of administration, administered in Left arm on 13May2021 at the age of 78-years-old for covid-19 immunisation. Prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine were none. Adverse events following prior vaccinations were none. Family medical history relevant to adverse events were none. Relevant tests were none. History of all previous immunization with the pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) were none. Additional vaccines administered on same date of the pfizer suspect were none. It was reported that event happened after the second dose of the vaccine. About a week after receiving the second dose, her lower lip broke out with cold sores on an unspecified date in Jun2021 and she has been fighting this more than a week now. She tried Zovirax (NDC and lot unknown, expiration date 31Mar2021) which usually helps with this but it did not this time. It has been years since this has happened. Yes, this has happened to some other people. It has been two weeks now. The Zovirax tamped it down a little but did not get rid of it like it normally does. She thinks her immune system is working and her immune system is causing the issue. It was reported that she had the normal flu like symptoms and headache on 04Jun2021 and it went away in under three days, she thought it was normal. The caller also had a sore arm on 03Jun2021 and aches and pains on 04Jun2021. By the fourth day the caller was fine. The caller wanted to make Pfizer aware that someone else had the herpes complex problem. The adverse events did not require a visit to Emergency Room or Physician Office. It was reported that age at time of onset of reaction/event was 78. Time of onset of adverse events was unknown. There was no investigation assessment. It was reported that she is tired of lock down and she does not want to wear a mask the rest of your life. She googled to see if anyone else had this come up and it seems to be a minor amount of people that have experienced it. She didnt expect for this to happen to her. The reporter assessed events as non-serious. The reporter assessed events relatedness to Pfizer covid vaccine as Related. The outcome of event, lower lip broke out with cold sores was not recovered while for other events was recovered on an unspecified date in Jun2021. Additional information is requested.
78 2021-06-23 pain in extremity day after getting the 1st dose she got a headache/chills/low temp/couldn't more left arm/arm, neck a... Read more
day after getting the 1st dose she got a headache/chills/low temp/couldn't more left arm/arm, neck and shoulder pain
78 2021-06-24 pain in extremity, muscle spasms spasms; her arms "tightens up" during the night; having trouble sleeping/she barely sleeps 3-4 hours... Read more
spasms; her arms "tightens up" during the night; having trouble sleeping/she barely sleeps 3-4 hours per night; muscle in her arm tightens up so tight it wakes her; both arms hurt from her elbows to shoulders and it is terrible at night.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: ER8737, expiration date: 31Jul2021) via an unspecified route of administration administered in Arm Left on 03Apr2021 (at the age of 78-years-old) as single dose for COVID-19 immunization. Medical history included ongoing breast cancer diagnosed 2.5 years ago and still being followed for it, ongoing irritable bowel syndrome diagnosed 5-6 years ago and had muscle aches in her legs from cholesterol medicines in the past. Concomitant medications included acetylsalicylic acid (ASPRIN, strength: 81 mg) at 81 mg once daily, bumetanide (strength: 1 mg) at 1 mg tables, 2 tablets on Monday, Wednesday and Friday and one tablet the rest of the week, glucosamine, methylsulfonylmethane (GLUCOSAMINE & MSM) one in the morning and one at night, 2x/day), letrozole (strength: 2.5 mg) at 2.5 mg once daily, levothyroxine (strength: 25 mg) at 25 mg, alternate day, lisinopril (strength: 5 mg) at 5 mg one at night, loratadine (CLARITINE), lorazepam, omeprazole (strength: 20 mg) at 20 mg, alternate day, probiotics once daily, calcium (strength: 600 mg) at 600 mg twice daily, vitamin c (ASCORBIC ACID, strength: 500 mg) at 500 mg once daily, vitamin d3 (strength: 500 mg) at 500 mg once daily, simethicone (strength: 125 mg) at 125 mg once daily. It was reported that within 2 days after vaccination, on 05Apr2021, the patient right arm started hurting from elbow to shoulder along with left arm then started hurting also but doesn't recall at what point it started. Patient thought that pain was due to the vaccine since in her left arm was also in pain. Further patient described pain as excruciating at night, in the evenings or when lays down, and tolerable during the day. On an unspecified date, the patient specified about the spasms and arms that tightens up during the night, which keep her up. On an unspecified date, the patient added she barely sleeps 3-4 hours per night, despite the muscle relaxant she takes. Patient further explained she cannot lift her arms as high in the morning and provided the following example: she couldn't open her venetian blind or put her coat without help. She specified the pain eases up during the day and can't move her arms as it hurts, the pain on a scale of 1-10 was a 15. Reporter assessed the event as non-serious. On unspecified date the patient underwent lab tests and procedures which included left arm x-ray and left arm x-ray found to be negative. The outcome of the events both arms hurt from her elbows to shoulders and it is terrible at night was not recovered while the outcome of the rest of events was unknown. Follow up attempts needed. Further information is expected.
78 2021-06-24 pain in extremity only side effect from the first one was a sore arm; This is a spontaneous report from a contactable ... Read more
only side effect from the first one was a sore arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER COVID VACCINE, Solution for injection) via an unspecified route of administration to her left arm on 13Jan2021 10:45 (age at vaccination: 78-year-old) (Lot number: EL8982, NDC number: Unknown, No Expiration) as single dose for prevention. Vaccination facility type: Clinic. The patient's medical history was reported as none. Concomitant medications were not reported. Family medical history reported as none. The patient previously took flu shots and experienced sore arm at site (annual flu shots). The patient had the first one three weeks prior and the only side effect from the first one was a sore arm. It was sore for about 30 hours. That was on the left arm. She received it on 13Jan2021. It was the Pfizer COVID vaccine with Lot EL8982, No expiration. Time of day was 10:45. No relevant test reported. Outcome of the event recovered on an unspecified date in Jan2021. PSCC Communication: Attempted to warm transfer caller to Pfizer Medical Information, however, due to extended hold time, caller opted to be transferred to hold place in the queue. Provided caller with websites of www.cvdvaccine.com and www.pfizermedinfo.com, along with phone of 800-438-1985, option 3, with hours of 8a-8p, Monday-Sunday. Follow-up attempts are completed. No further information is expected.
78 2021-06-24 pain in extremity Beginning approximately two days after my first vaccine shot, I have experienced joint pain and stif... Read more
Beginning approximately two days after my first vaccine shot, I have experienced joint pain and stiffness. It is most prevalent in my left shoulder and the middle finger of my right hand. I have not had pain in these places before. I have also had pain and stiffness in my knees and lower back, and I have had problems in these places before. The pain is not debilitating and is relieved with Advil and Tylenol. I expected it to just resolve itself, but it has not. I have communicated this to my health care provider, Dr. , by telemedicine.
78 2021-06-24 tremor chills; shaking; not feeling well; This is a spontaneous report received from a contactable Consumer... Read more
chills; shaking; not feeling well; This is a spontaneous report received from a contactable Consumer (patient's husband). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318 and Expiration date was not reported), via an unspecified route of administration, in right arm, on 06Feb2021, Saturday (at the age of 78 years), as a single dose for covid-19 immunization. The patient medical history included A Fib and mitral valve replacement (caller states that his wife has had two mitral valve replacements, as she out-lived the first one). Concomitant medications included Jantoven (warfarin sodium) for a fib and mitral valve replacement. The patient had taken Covid vaccine for Covid prevention. On 07Feb2021, the next day, the patient had experienced not feeling well, chills, and shaking. Caller states that he wrapped his wife in a bunch of blankets and finally after about three hours, it subsided. Caller states that this morning, his wife got up and went to the bathroom and before she could get back to bed, she started to shake again. Caller is wondering if this is a normal side effect of the product. Caller confirmed that his wife had no other vaccines on the same day as the COVID vaccine. The outcome of the event chills was recovered on an unspecified date in 2021. The outcome of the event shaking was not recovered. The outcome of the event not feeling well was unknown. Follow-up attempts are completed. No further information is expected.
78 2021-06-28 feeling of insects crawling on skin I had itchiness and swelling around my eye. I thought it was a bug bite but it kept getting worse. E... Read more
I had itchiness and swelling around my eye. I thought it was a bug bite but it kept getting worse. Eventually, I had a rash around my eyes, my forehead, my hair. I went to the urgent care where they prescribed me an antiviral. The antiviral seems to be slowing things down. I am also now experiencing a crawling sensation throughout my body. It feels as if a bug crawling on me. This is something new that I have never experienced before.
78 2021-06-29 weakness One day after first dose of Pfizer vaccine, patient was admitted for fever, weakness and altered men... Read more
One day after first dose of Pfizer vaccine, patient was admitted for fever, weakness and altered mental status. At admission exhibited SIRS (fever, tachycardia), ultimately no infection was identified on work up.
78 2021-06-29 weakness feels lightheaded; fever; chills; headache; stomach upset; could not eat; diarrhea; aches all over; ... Read more
feels lightheaded; fever; chills; headache; stomach upset; could not eat; diarrhea; aches all over; weak; This is spontaneous report from contactable consumer. This consumer (patient) reported that a 78-years-old female patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot Number: EW0170), (at the age of 78-years-old) via an unspecified route of administration on 28Apr2021 at 15:00 (Wednesday afternoon) on right arm as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that after received shot she had been sick ever since. She has been taking two Tylenol every six hours. On 28Apr2021, the patient feels lightheaded when she gets up, fever and chills at night, headache, stomach upset, could not eat up until today and stated that she ate jello, diarrhea, stated that she did not known if she can drive or not that she was weak, aches all over and that the other day when she had the headache that Tylenol would not take it away. Stated that she was okay when she got it and it took 4 hours to get sick. Stated that she could not even drive. Stated that she had Covid on 28Jan2021 and waited 90 days to get the shot. The patient treated herself by using cold packs. The outcome of adverse events feels lightheaded, stomach upset, diarrhea, weak and aches all over was not recovered. On 29Apr2021, fever, chills were recovered. On 30Apr2021, headache was recovered. The outcome of adverse event could not eat was unknown. No follow-up attempts are needed. No further information is expected.
78 2021-06-29 muscle spasms neck spasms; diarrhea; the urge to go to the bathroom all day long; a bloating abdomen with a lot of... Read more
neck spasms; diarrhea; the urge to go to the bathroom all day long; a bloating abdomen with a lot of gas; a bloating abdomen with a lot of gas; feeling severe muscle pain in the stomach; This is a spontaneous report from a contactable consumer. This 78-year-old female consumer (patient) reported. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 (at the age of 78-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient called to report her symptoms after the administration of the second dose of the Pfizer's COVID-19 vaccine. On 06Feb2021, the patient started having neck spasms, diarrhoea, and the urge to go to the bathroom all day long, also a bloating abdomen with a lot of gas, feeling severe muscle pain in the stomach. She stated her symptoms were not putting her on risk based on the information that she received about the vaccine when it was administered to her. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
78 2021-06-29 pain in extremity gas; fatigued; chills; loose stools; slight body aches; slightly right sore arm; This is a spontaneo... Read more
gas; fatigued; chills; loose stools; slight body aches; slightly right sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in Right arm on 29Jan2021 (at the age of 78-year-old) as single dose for covid-19 immunisation. Medical history were none. There were no concomitant medications. The patient experienced chills on 03Feb2021 slightly loose stools on 03Feb2021, gas on an unspecified date, fatigued on 03Feb2021, slightly right sore arm on 29Jan2021, slight body aches on 03Feb2021. Therapeutic measures were taken with a couple of Tylenol and Pepto Bismol as a result of event chills, loose stools, gas, fatigued, slightly right sore arm, slight body aches. The outcome of event gas was unknown and for event slightly right sore arm was recovered on 30Jan2021 and slight body aches was recovered on 07Feb2021 and for rest all event outcome was recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
78 2021-06-29 pain in extremity Individual contacted 06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she exp... Read more
Individual contacted 06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she experienced left arm pain 3 days following injection, pain persists in left arm and is constant, unable to reach above shoulder level, unable to lay on left side, complains of weakness in left arm, unable to sleep, complains of weight loss and "acid reflux" since receiving vaccine. Denies any fever, rash, cough, cold symptoms s/p vaccine. She states she has treated with her PCP and Occupational Therapy for her complaints with no relief, she relates PC and OT have diagnosed her with "bursitis".
78 2021-06-30 pain in extremity polymyalgia rheumatica; Patient received the vaccine in left arm on 03Apr2021. On 05Apr2021 he exper... Read more
polymyalgia rheumatica; Patient received the vaccine in left arm on 03Apr2021. On 05Apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse.; Patient received the vaccine in left arm on 03Apr2021. On 05Apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse.; This is a spontaneous report from a contactable consumer (reported for herself). A 78-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on an unspecified date (at the age of 78-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8737/Batch was not reported), dose 1 via an unspecified route of administration, administered in arm left 03Apr2021 (at the age of 78-years-old) as dose 1, single for covid-19 immunisation and experienced muscle pain in upper right arm on 05Apr2021. The reporter stated that patient received the vaccine in left arm on 03apr2021. On 05apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse and contacted her physician. Physician ran multiple blood work, ruled out possibilities and gave me a diagnosis of PMR (polymyalgia rheumatica). Started prednisone 30 msg on 24May21 in decreasing doses. Pain was relieved and she still on the medication. The reporter stated that patient have never experienced such intense pain in her life. Physician attributed her pain to the vaccine. The event polymyalgia rheumatica assessed as serious. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date. The reporter stated the events result Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of patient for the events with prednisone 30 msg started on 24May2021. The outcome of the events pain in extremity, condition aggravated was resolving and polymyalgia rheumatica was unknown. Information about lot/batch number has been requested.
78 2021-06-30 tremor dizzy; cramping in stomach; hard to swallow solid food; body shook; chills/teeth chattered; BP rose ... Read more
dizzy; cramping in stomach; hard to swallow solid food; body shook; chills/teeth chattered; BP rose to 170/89; felt jittery; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported that a 78-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing high BP Onset date: 5+ years Stop date: Ongoing Pertinent details: Controlled; ongoing acid reflux disease Onset date: 10+ years Stop date: Ongoing Pertinent details: Controlled. There were no concomitant medications. On 20Feb2021, the patient experienced BP rose to 170/89; felt jittery; chills/teeth chattered; body shook; On 21Feb2021, dizzy; cramping in stomach; hard to swallow solid food. The patient underwent lab tests and procedures which included blood pressure measurement: 217/105 mmhg on 28Jan2021, blood pressure measurement: 170/89 mmhg on 20Feb2021, pyrexia: 103 on 28Jan2021. It was reported that patient took 2nd shot on Wednesday 17Feb. On Saturday 20Feb BP rose to 170/89 felt jittery. On Sunday 21Feb become jittery, dizzy, BP high and had cramping in stomach. Hard to swallow solid food. Went on until doctor ordered Dicyclomine. It helps. On Saturday 20Feb had chills for 2and half hours. Teeth chattered and body shook. Stomach was still cramping after 2and half weeks and solid food is hard to swallow. I have an appointment with a gastrologist. The clinical outcome of all events were unknown. No follow-up attempts are possible. No further information is expected.
78 2021-07-01 weakness, burning sensation, pain in extremity She got her vaccine, and started feeling real dizzy and stumbling around and cold not do anything, a... Read more
She got her vaccine, and started feeling real dizzy and stumbling around and cold not do anything, and has had no energy and was in a wheelchair for a little while. She went to her PCP and he told her that she had an infection from the Covid shot, and gave her some antibiotics and some prednisone. This did not help. She was able to walk with her rolling walker before but since then she has had this problem. Her hands hurt, burn, turn red. She drops things steadily. When she gets up in the morning she is not able to do much as she drops things. She still has the same symptoms, and still having no energy and not herself. Her son has now moved in with her to help her as she is not able to take care of herself anymore.
78 2021-07-01 pain in extremity Headache; Chills; Muscle ache; Joint ache; Left arm pain; Feeling "sick"; Slight fever; This is a sp... Read more
Headache; Chills; Muscle ache; Joint ache; Left arm pain; Feeling "sick"; Slight fever; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6207), via an unspecified route administration in the left arm on 19Mar2021 at 12:45 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to mites, grass pollen, cats and latex (skin contact). Concomitant medications included multiple vitamins (MANUFACTURER UNKNOWN), losartan potassium (MANUFACTURER UNKNOWN) and bifidobacterium infantis; lactobacillus acidophilus (PROBIOTICS); all from unknown dates for unspecified indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6205), via an unspecified route administration in the left arm on 26Feb2021 at 00:15 (at the age of 78-years-old), as a single dose for COVID-19 immunisation and received doxycycline hyclate (MANUFACTURER UNKNOWN) and potassium dichromate (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. On 19March2021 at 14:00, the patient experienced headache, chills, muscle ache, joint ache, left arm pain, feeling sick and slight fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events headache, chills, muscle ache, joint ache, painful left arm, feeling sick, fever was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.
78 2021-07-02 pain in extremity Rash; Fever; Headache; Fatigue; Swollen sore arm; Swollen sore arm; This is a spontaneous report fro... Read more
Rash; Fever; Headache; Fatigue; Swollen sore arm; Swollen sore arm; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 18Mar2021 at 09:45 (at the age of 78-years-old), as single dose for COVID 19 immunisation. Medical history included acid reflux, coronary artery, pre-diabetic and bee venom allergy. Concomitant medication included omeprazole (MANUFACTURER UNKNOWN), levothyroxine (LEVOTHYROXIN), telmisartan (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), cefuroxime (FURO); all for unspecified indication from unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in the left arm on 25Feb2021 at 09:30 (at the age of 78-years-old) as single dose for COVID 19 immunisation. The patient previously took ampicillin (MANUFACTURER UNKNOWN), azithromycin (MANUFACTURER UNKNOWN), levofloxacin (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN); all from unknown dates to unknown dates for unknown indications and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 17:00, the patient experienced fever, headache, overall fatigue and swollen sore arm that lasted for 4 days. On 23Mar2021, fifth day onwards, the patient experienced rash and patient still had it on 24Mar2021 (sixth day). The patient did not receive any treatment for the events. The clinical outcome of the events fever, headache, overall fatigue, swollen arm and pain in arm were recovered on 22Mar2021 and rash was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.
78 2021-07-06 weakness, sciatica Colon cancer metastatic; Lung disorder; Kidney stones; Kidney cancer; Vomiting; Pain worsened; Back ... Read more
Colon cancer metastatic; Lung disorder; Kidney stones; Kidney cancer; Vomiting; Pain worsened; Back ache; Thyroid nodule; Lung nodule; sciatica; Nauseous; Light-headed; Feelings of weakness; Difficulty in walking; This is a solicited report from a marketing program received from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular on 29Mar2021 (Batch/Lot Number: ER8733) at age of 78 years old as single dose for covid-19 immunisation; upadacitinib (RINVOQ), oral from Dec2019 (Batch/Lot number was not reported) and ongoing, at 15 mg, once per day for moderate to severe rheumatoid arthritis. Medical history included non-smoker: secondary tobacco exposure, abstains from alcohol, high blood pressure, glaucoma, rheumatoid arthritis, muscle cramps in legs, cholesterol, acid reflux, and dry eyes. The patient had a relevant medical history of osteoporosis, hiatal hernia, DURICEF allergy manifested by pseudomembranous colitis. The patient had secondary tobacco exposure. She had history of usage of Remicade for unknown indication. Concomitant medications included amlodipine taken for hypertension; vitamin D3 taken for supplementation therapy; ciclosporin (RESTASIS) taken for dry eye and glaucoma; latanoprost taken for eye disorder; folic acid taken for rheumatoid arthritis; methotrexate taken for rheumatoid arthritis; magnesium taken for muscle spasms; fish oil taken for blood cholesterol; omeprazole taken for gastrooesophageal reflux disease; all start and stop date were not reported. Solicited report by a consumer of a female with events of colon cancer metastasize to the liver, kidney cancer that possibly moved onto liver, vomiting, back ache, pain worsened, spot on the lung and kidney stones and non-serious lightheaded, felt weak, could hardly walk, nodule on thyroid and right lung and nauseous with RINVOQ (upadacitinib). On unknown dates, the patient experienced kidney cancer that possibly moved onto liver and nodule on thyroid and right lung. On 29Mar2021, the patient experienced lightheaded, felt weak, could hardly walk and nauseous. On 29Mar2021, the lightheaded, felt weak, could hardly walk and nauseous resolved. In May2021, the patient experienced back ache. On 29May2021, the patient experienced vomiting and pain worsened. On 02Jun2021, the patient experienced kidney stones. On 03Jun2021, the patient experienced colon cancer metastasize to the liver and spot on the lung. On 03Jun2021, the vomiting resolved. On 17Jun2021, the kidney stones resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. On 27May2021, she was sent to the emergency room because of back ache and was given prednisone. In Jun2021, she had a terrible back ache. She thought she had sciatica. In Jun2021, she went to the doctor, physician pressed on her back and she went through the roof. She was vomiting and had pain in her back and her daughter took her to the emergency room and did x-ray and cat scans and she had kidney stones and she was having an ultra sound. Went back to the emergency room from 02Jun2021 until 04Jun2021 because of vomiting and pain. She also had kidney cancer that had possibly moved onto her liver. She had an endoscopy done. The biopsy and other tests to decide what was going to happen. There was a nodule on her thyroid and her right lung. She felt ok and had a little backache at times, but she was taking. She already had the COVID-19 vaccines first dose but was advised not to had the second dose because of the adverse events she experienced after the first dose. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 29Mar2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number ER8733. The patient was treated with PREDNISONE. Relevant laboratory and other diagnostic tests included: 17Jun2021 abdominal ultrasound: No more kidney stones; Unknown date biopsy: Unknown; Jun2021 CAT scans: Kidney stones; 03Jun2021 chest X-RAY: Spot on the lung; 04Jun2021 colonoscopy: Colon cancer; 03Jun2021 computed tomography scan: Colon cancer metastasize to the liver; 04Jun2021 endoscopy: Hiatal hernia; Jun2021 endoscopy: Unknown; Unknown date lab tests: Unknown; Unknown date ultrasound: Unknown; Jun2021 X-RAY: Kidney stones. The action taken in response to the events for suspect product upadacitinib was dose not changed. The outcome of events colon cancer metastatic, kidney cancer, and lung disorder was not recovered, events vomiting was recovered on 03Jun2021, kidney stones was recovered on 17Jun2021, light-headed, feelings of weakness, difficulty in walking, and nauseous was recovered on 29Mar2021, events back ache, and pain worsened was recovering, of other events was unknown. Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of colon cancer metastasize to the liver, vomiting, back ache, pain worsened, spot on the lung, kidney stones, lightheaded, felt weak, could hardly walk, nodule on thyroid and right lung unknown onset, nodule on thyroid and right lung unknown onset and nauseous was not provided. The reporter's causality for the event(s) of kidney cancer that possibly moved onto liver with RINVOQ(UPADACITINIB) was no reasonable possibility. (Withheld) opinion is that the events of colon cancer metastasize to the liver, kidney cancer that possibly moved onto liver, spot on the lung, nodule on thyroid and right lung unknown onset and nodule on thyroid and right lung unknown onset are not assessable. (Withheld) opinion is that there is no reasonable possibility that the events of vomiting, back ache, pain worsened, kidney stones, lightheaded, felt weak, could hardly walk and nauseous are related to RINVOQ(UPADACITINIB). The reporter's assessment of the causal relationship of the events with the suspect vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Considering the close temporal association, a causative role of BNT162B2 vaccine for the reported Light-headed, Feelings of weakness, Difficulty in walking, and Nauseous cannot be excluded. All other events are considered unrelated to BNT162B2 vaccine.
78 2021-07-06 burning sensation, pain in extremity Nausea; Flu like symptoms; a flare with hands and achiness/sitting for long times everything started... Read more
Nausea; Flu like symptoms; a flare with hands and achiness/sitting for long times everything started hurting; Condition aggravated/flare/a flare with hands and achiness; Bilateral cataracts; Depression; Vomiting; Back pain; Foot pain/fingers hurt; Shoulder pain; Localised erythema; her joints continued to be swollen at times; Diabetes; Heart disorder; Osteoarthritis; Joint range of motion decreased; Lower extremity mass; finger would not bend was straight as a board; Burning finger; one finger was bruised looking; swollen finger on left hand/hand swelling; This is a solicited report from a non-Pfizer sponsored marketing program (MARKETING PROGRAM NAME NOT AVAILABLE) received by Pfizer from AbbVie Inc. A contactable consumer (patient) reported that a 78-year-old female patient received tozinameran (PFIZER BIONTECH COVID-19 VACCINE), dose 2 intramuscular in Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to Feb2021 at citrate free 40 mg, 1 in 1 week for moderate to severe rheumatoid arthritis and moderate to severe adult crohn's disease. Medical history included moderate to severe rheumatoid arthritis, moderate to severe adult crohn's disease. The patient's concomitant medications were not reported. The patient previously received first dose of tozinameran intramuscular in 2021 for covid-19 immunisation. The patient previously took adalimumab from 05Dec2019 and experienced lack of drug effect; On 16Apr2020, the patient experienced body aches. On 01May2020, the body aches resolved; fatigue from 2019, Urinary tract infection from 2020 to 2020, recovered; recurrent urinary tract infection from 2020. She had another urinary tract infection and she was placed on another unknown antibiotic therapy. On 14Apr2020, the patient was taking ciprofloxacin shot for urinary tract infection however it made her sick and had vomiting, depression and pain and therapy stopped. The patient experienced events of condition aggravated, flare, cataracts on both eyes (bilateral cataracts), nausea and flu like symptoms and non-serious heart condition (heart disorder), osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, joint range of motion decreased, lump on left knee (lower extremity mass), one finger was bruised looking/burning (burning finger) and swollen finger on left hand from 02Mar2021, hand swelling, depression, diabetes, vomiting, after taking covid vaccines, a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, redness in the hand (localised erythema) and swelling in hand with humira (adalimumab). Pfizer biontech covid-19 vaccine (tozinameran) was considered suspect. She was hospitalized due to extreme flares, body aches, flu like symptoms and nausea. She went to the eye specialist and was diagnosed with cataracts. she was told by her primary physician that she had a heart condition. she reported that her joints continued to be swollen at times and painful. She had shoulder, back pain, foot pain and also had osteoarthritis that affected her knees and hands. She took humira weekly and thought humira helped with pain. She also had diabetes. She stopped humira after taking covid 19 vaccines. She had swelling and redness in her hands and lump on her left knee. Her fingers were swollen, hurt and look bruised. she could not bend two fingers on left hand and thumb. she feels that all of her symptoms started after the second Pfizer covid 19 injections. She developed body aches and a flare with hands, achiness and restarted taking her humira. In 2021, she had cataract surgery on both eyes and had the outcome for the cataract surgery on both eyes was reported as recovered. when sitting long times, everything started hurting. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient was treated with kenalog, prednisone and amoxcillin. The patient underwent lab tests included body temperature: normal value. The action taken in response to the events for adalimumab was unknown. The outcome of events flare, cataracts, nausea, flu like symptoms, was recovered; everything started hurting, back pain, swelling of fingers was not recovered; other events was unknown. The report was considered involved or prolonged inpatient hospitalization and other medically important condition. Causality for humira (adalimumab): the reporter's causality for the event(s) of flare, body aches, nausea, flu like symptoms, depression, vomiting, lack of effect and urinary tract infection with humira(adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of cataracts on both eyes, heart condition, fatigue, osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, lump on left knee, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, diabetes, another urinary tract infection, after taking covid vaccines and developed body aches and a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, redness in the hand and swelling in hand was not provided. Abbvie's opinion is that there is no reasonable possibility that the events of flare, cataracts on both eyes, fatigue, osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, lump on left knee, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02 mar 2021, depression, diabetes, vomiting, lack of effect, after taking covid vaccines and developed body aches and a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, redness in the hand and swelling in hand are related to humira(adalimumab). Abbvie's opinion is that there is a reasonable possibility that the events of body aches, nausea, flu like symptoms, urinary tract infection and another urinary tract infection are related to humira(adalimumab). Abbvie's opinion is that the event of heart condition is not assessable. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed; information about batch/lot number cannot be obtained.; Sender's Comments: Reported events nausea, flu like symptoms, and vomiting are assessed as related to the suspect drug based on drug safety profile and temporal association. Other events are probably associated to patients underlying condition and are not related to BNT162B2. Case to be re-assessed upon receipt of new information.
78 2021-07-10 migraine Has terrible fatigue; The blood work showed swelling and the doctor is monitoring that; The caller s... Read more
Has terrible fatigue; The blood work showed swelling and the doctor is monitoring that; The caller states people can verify seeing the caller walk with a cane; Dizziness; Body aches from the left side of body that move through neck and to the head; Has been having migraine headaches; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6203) via an unspecified route of administration on 01Mar2021 as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. The patient's concomitant medication included prednisone (PREDNISONE: Started out taking 10mg, after told Doctor it was bothering the caller, reduced to 7.5mg and now the caller was on 5mg once a day.) on 13Apr2021, furadantin taken in 1985 (PRE Covid vaccine) where she was hospitalized and in a coma for 3 days. On 01Mar2021, the patient had migraine headaches. On 03Mar2021, the patient experience Body aches from the left side of body that move through neck and to the head, had terrible fatigue was reported as worsened and dizziness. The migraine headache started three hours after receiving the second dose Pfizer Covid Vaccine. The migraine that day lasted for 10 hours and finally got the headache to go away. The headaches have been on and off. Body aches from the left side of the body that move through the neck and to the head. The body aches had the reporter in the bed. The caller had two good days and then four bad days. The doctor had the reporter on Prednisone for rheumatoid arthritis. Body aches from the left side of body that move through neck and to the head: The patient was lying down because this was one of the days the patient cannot move around. Everything was aching on the caller's body. The patient was trying to get up. She had never had arthritis. The doctor was treating her for arthritis. The patient had never heard of onset arthritis three days after receiving a vaccine, second dose Pfizer Covid Vaccine. The patient states she called the number on the paper that was provided from the vaccination facility and mentioned everything. The reporter states it was just like a recorded thing. In the meantime, the reporter thought every morning when the caller woke up, thought it would all be gone, and the caller would be fine. The reporter was a normally healthy woman with no underlying side effects, no underlying conditions rather. When asked if it was Pfizer the patient called and reported the events to, the reporter replied she did not keep the paper, but it said to call Pfizer at this number, no person answered, and it was leaving a message. Had been having migraine headaches: The reporter had migraine headache on the left rear quadrant of the head. The headache was like something piercing the head all by itself. The reporter states a migraine headache lasted 10 hours and began three hours after receiving the second dose Pfizer Covid Vaccine. body aches: two days later, had terrible fatigue and it was difficult for the patient to get off the couch and the terrible fatigue had been on and off. The caller had one good day and one bad day. Had been having migraine headaches: The terrible fatigue began as soon as the caller was up with migraine for 10 hours. The migraine continued with a moderate headache which persists still today, 02Jun2021. The reporter may go a day or two without the headache, but it keeps coming back. The patient underwent lab tests and procedures which included blood test: showed swelling and other than that was normal. The outcome of events swelling, and gait disturbance was unknown, and the outcome of remaining events was not recovered. No follow-up attempts are possible. No further information is expected.
78 2021-07-12 weakness went right back to sleep after her call and didn't wake up till next morning,; dull headache; head w... Read more
went right back to sleep after her call and didn't wake up till next morning,; dull headache; head was swimming; blood pressure went to 220/blood pressure was really high; black spots across my face; swimmy headed; legs didn't feel like they would hold her up/felt like my legs weren't going to hold me up; weak; very fatigued; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8731), via an unspecified route of administration, administered in left arm on 15Apr2021 13:15 (at the age of 78-years-old) as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She had her shot and just had a bad reaction to her very first shot. She came home, states sometimes she may doze off for 15 minutes or so but she fell asleep until at 16:00 she was woken up by a call from a friend. On 15Apr2021, she felt very fatigued and weak on Friday; later adds she was tired the day of shot as well. She laid around all day sleeping on Friday. On 17Apr2021 Saturday her legs didn't feel like they would hold her up and so she laid around again all day. On 18Apr2021 Sunday she knows had gotten up to go to bathroom a couple of times in the night; but then in the morning she was going to get up and felt faint; later adds she felt dizzy; states her head was swimming and she saw black spots and it scared her to death. Adds she thought she should go and sit up in the living room. But even after she sat down, sitting straight up, she kept seeing black spots. A friend took her to the emergency room (ER) for the dizziness and seeing spots. At the ER they found her blood pressure was really high; she thinks it was 220 over something, she forgot the bottom figure. They put an IV in to give her medication; did an electrocardiogram; a chest xray; blood work; a urinalysis and all of those tests everything was fine. The ER staff helped her to bathroom and her head was still swimming but they said that was because her blood pressure was still high. Adds her blood pressure went down on it's own and she had no medication for the blood pressure. They told her you are remarkable at your age to not to be on medication. She saw her doctor yesterday. Reports at the doctor's office her blood pressure was about 128/63. The doctor told her it was kind a low and that she basically runs low. She was not dizzy anymore on Sunday after her blood pressure went down. Adds she got a dull headache yesterday but she thinks it might of been a caffeine headache because she has had a caffeine headache in the past when she had to stop caffeine for a test or something. She has to take the second dose on 06May2021, and her doctor told her to take it; but she is scared to death. She asking for a recommendation as to whether she should get the second dose. The adverse event resulted the patient to visit emergency room and was not admitted and also visited to physician office. Outcome of the event hypertension was resolved on 18Apr2021, while for events- black spots across my face, dull headache, swimmy headed, feeling abnormal, head was swimming was resolved on 19Apr2021 and that for fatigue, weak was not recovered and sleep disorder was unknown. No follow-up attempts are possible. No further information was expected.
78 2021-07-12 tingling Pt. states after receiving 2nd Phizer 04/01/2021 started experiencing pins and needles in the feet a... Read more
Pt. states after receiving 2nd Phizer 04/01/2021 started experiencing pins and needles in the feet advancing to the arms and head 06/01/2021. ER visit 06/292/2021 resulted in recommendation for a Neurologist visit. Appt. set for 07/20/2021
78 2021-07-13 mild one side paralysis, numbness TIA, right side of body weakened to point of not being able to stand, left side of face numb, emerge... Read more
TIA, right side of body weakened to point of not being able to stand, left side of face numb, emergency hospital 24 hours for monitoring and tests.
78 2021-07-15 seizure Massive seizure, with no history of seizures, occurred within minutes of injection. Given Ativan at ... Read more
Massive seizure, with no history of seizures, occurred within minutes of injection. Given Ativan at Center then moved by ambulance to Hospital emergency room while unconscious. Was sedated, intubated, and put on ventilator. Full range of tests performed, such as cat scan, MRI, EEG. Home in a week, back to normal (taking anti-seizure med) by second week. Hospital said seizure was due to alcohol withdrawal, which is ridiculous. Furlong did not stop drinking before the seizure. He was told to stop drinking afterward, which he did with no problems whatsoever. Then went to PCP, neurologist, and cardiologist. Multiple tests, but still no cause for seizure found.
78 2021-07-16 flushing, seizure, tingling, numbness Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of... Read more
Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Seizure-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe
78 2021-07-17 limb paralysis shoulder blades started hurting/then the pain went down to both hips and her back too; collar bones ... Read more
shoulder blades started hurting/then the pain went down to both hips and her back too; collar bones they started hurting like hell; then the pain went down to both hips and her back too; pain all over the body; could not move there left arm or neck; Physician instructed patient not to get second dose of Pfizer Covid Vaccine so patient did not get second dose as scheduled for 18Jun2021; pretty bad headache/headaches; severe chills and temperature; severe chills and temperature/chills; move her left arm where she had gotten the shot and couldn't move it/ arm was paralyzed; This is a spontaneous report received from a contactable consumer (patient). This is report 1 of 5. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration in left arm on 28May2021 at 17:30 as single for covid-19 immunization (at the age of 78years). The patient medical history included First serious fall from May2021 to an unknown date-Shattered left hip that was May2019; shattered left hand and wrist; When shattered left hip they had to fix the shattered hip then they put a metal rod from the hip to the kneecap inside the femur bone. Second serious fall from 27Nov2019 to 27Nov2019, fell again in her home and that time she shattered the left knee, hip fracture- Broke right hip 4 or 5 times, shoulder arthroplasty- On the right arm. She broke that right before get to the shoulder, the upper arm and the shoulder and everything was all mangled, stevens-johnson syndrome from on an unspecified date in 1954 and ongoing-very severe autoimmune disease she got at age of 12, in roughly 1954. It is also called Erythema bullosum-that's what it starts out as-then becomes Stevens-Johnson Disease, then Stevens-Johnson syndrome. Affects mucus membranes in body and appears to be rejecting the eyes-this is relative to her blindness. When contracted had 108 degree fever, implantable defibrillator insertion from on an unspecified date in 2015 and ongoing- installed back about 6 years. She was taking some kind of, the numbers are way down now, she does not think there's a problem but they were thinking she was prediabetic which was probably attributed to her diet. The day before they did the blood test she had ice cream for lunch and for dinner. Then she had the blood test taken the next morning which could have set the numbers off the chart; since then the numbers have gone down. glucose tolerance impaired. They were thinking she was prediabetic and blind from an unknown date and unknown if ongoing, wheelchair user from an unknown date and unknown if ongoing. She only has 1 eye now-left eye; has been legally blind since age 24 years; now left eye is just about gone. She was the 5th person in the world to have Stevens-Johnson syndrome with blindness that could still see and lived. First 3 people with Stevens-Johnson syndrome died-4th lived but was blind. Concomitant medication's included sertraline hydrochloride (ZOLOFT), diazepam (VALIUM), hydrocodone bitartrate, paracetamol (VICODIN), cholesterol (CHOLESTEROL) taken for an unspecified indication and Unknown product: Some kind of stomach pill, does not know, it is the size of caraway seed in rye bread. Regarding concomitant medications caller reported she has no idea. She is taking products that the drug store puts a bubble pack for her. She was taking high blood pressure but her blood pressure was never high, it always ran on the low side; but they started giving her that when she had a pacemaker and defibrillator 2-in-1 installed back about 6 years ago. Otherwise unknown. Cholesterol meds but those numbers are all under control. She has been having trouble; so she thinks this is the last months she is getting her meds after that she thinks she is stopping everything. There's 5 or 6 meds in the morning and 2 at night, one is cholesterol from #. She cannot provide further information for her concomitant products as she is blind-Lots/NDCs/Expiries: Not provided, She cannot provide further information for her concomitant products as she is blind. With the old flu vaccines with the live viruses she was always coming down with the flu after getting the injections. Patient was not diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient did not visit emergency room or physician office. Adverse reaction was very bad: Started out with pretty bad headache around noontime, 12:00 on 29May2021 with the most severe part of event starting probably about 22:00. From there it went to severe chills and temperature. Then she went to move her left arm where she had gotten the shot and couldn't move it; she tried to move her fingers and make a fist but couldn't do it; the arm was paralyzed. Then her shoulder blades started hurting like hell, like incredible. If she had a gun she would have put it to her head. Then where the neck connects to the body, collar bones she guessed; in between like if she had an adam's apple it would be on both sides of those bones that are right beside the neck, they started hurting like hell. The paralyzed arm the pain coming from that was incredible; then the pain went down to both hips and her back too; but back wasn't as severe as the bones. All of Saturday, 29May2021 into Sunday, 30May2021 she was unable to get out of bed. This whole thing just intensified, she had nobody there; she lives in senior housing, they are confined to their quarters, to their apartments, the whole thing. She did not have access to anyone, had problems with her phone with no dial tone, nothing. Finally on Sunday, 30May2021 early evening she was able to, she would say, slither out of bed on her back and drop her feet over the edge of the mattress so those are kind of like on the floor. Her wheelchair is next to her; she has to get her upper body upright to be in seated position to be able to get into the wheelchair which was damn near impossible to do. She never knew that kind of pain existed. She was then able to get into the bathroom and use that. She had nothing to drink because obviously if you drink have to urinate and use the bathroom there was no way she was going to go through that again. She thought at that time she might as well go and unlock the door so if an ambulance does come they can haul her to the hospital or they could retrieve her body. She was totally convinced she was going to die on Sunday night into Monday morning, 30May2021-31May2021. She was up until 04:30 on Monday morning, 31May2021 because she was so scared if she fell asleep she would pass away in her sleep. The pain she could not describe how bad that was. That was Monday morning, 31May2021, all of this interim information she is discussing here; basically she was a total mess until it started backing off on Wednesday, 02Jun2021. She was told by the commission for the blind, that they were able to set up the appointment with # because she was due for in-home inoculation with J&J but when they had trouble with that it was pulled and the appointments were cancelled. The commission for the blind took it upon themselves to set up appointment for her Pfizer Covid Vaccine which was given at # on 8 #. #-that was where her Pfizer Covid Vaccine was administered. She did not call anyone or go to the doctor, emergency room or hospital; she has life alert but thought it was in God's hands so if he takes her he takes her. She did not call her daughter. She did call her doctor the early part of last week; he wants her to have a blood test to check for antibodies to see how much of the vaccine is in her or how much she is covered. Once he sees those numbers he says maybe she should get the J&J Covid Vaccine, but if she already got the Pfizer Covid Vaccine and with the J&J trouble with that too, that does not even make sense. She asked for information about that. She was due for a physical about a week ago but her daughter was unable to take her to her physical appointment because she had to take granddaughter to hospital because granddaughter has a hole in her heart and they had to do some testing on her. The patient underwent lab test which included body temperature of 108 degree on 29May2021. The outcome of events were unknown. Information about lot/Batch has been requested.
78 2021-07-18 unresponsive to stimuli Unresponsiveness, flash pulmonary edema, intubated,
78 2021-07-20 pain in extremity I had no issues with 1st dose. After taking the 2nd dose, I played golf afterwards. By the end of th... Read more
I had no issues with 1st dose. After taking the 2nd dose, I played golf afterwards. By the end of the round, I was having pain in my left foot. The pain got worse to where I couldn't walk on it. The pain went up my leg to my knees. The next day, I went to the Ortho Indi facility. They did an x-ray on me that indicated that there was no structural damage to cause pain. The doctor recommended me to put on a boot that go up to my knees and to ice it. I did that from Wednesday through Sunday. The pain went away. Every now and then I would get a sharp pain in my left foot, but then it goes away.
78 2021-07-21 pain in extremity same pain feeling in bladder and pelvis; Sore arm; had pain that was just in the knee replacements, ... Read more
same pain feeling in bladder and pelvis; Sore arm; had pain that was just in the knee replacements, where knee replacements; Pain; pain in her pelvis; Standing up feels weird; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN6200), via an unspecified route of administration, administered in the left arm on 28-JAN-2021 16:00 as 1stdose, single for covid-19 immunisation. The patient received second dose BNT162b2 (CONMINTARY, Solution for injection, Lot No: EL9261), via an unspecified route of administration, administered in the left arm on 05-MAR-2021 16:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history included ongoing cardiac disorder heart condition , ongoing hypertension high blood pressure , cardiac operation from 25Jan2020 to 25Jan2020 heart surgery , knee arthroplasty from Jan2014 to an unknown date double knee replacement surgery made out of unknown titanium and plastic , office visit from an unknown date and unknown if ongoing foot doctor appointment , biopsy uterus from an unknown date and unknown if ongoing scheduled for a biopsy on her uterus , breast cancer from Sep2020 to an unknown date breast cancer , arthritis from an unknown date and unknown if ongoing arthritis , immunisation from an unknown date and unknown if ongoing very active , genetic counselling from an unknown date and unknown if ongoing genetic testing relative for breast cancer, heart surgery for other conditions was 2 heart stents placed, double knee replacement surgery was the prosthetics are each 9 inches made out of unknown titanium and plastic. Caller interchangeably referred to surgical date as Jan2014 and about 5 years ago. She was fine without any assistance for about 4 years never needed to use canes or walkers only at 1st when had replacements-did for that immediate after surgery-was down 4 months with replacements. Foot doctor appointment was she will tackle soon. Scheduled for a biopsy on her uterus was she is concentrating on that once she gets past that they picked that up in annual pelvic exam about a month ago; if that doesn't have any lasting need for any further treatment she will tackle this knee pain, breast cancer was 1st stage taken care of no further mammograms not on any medication for it; operated on Sep2020 until now another part of her needs to be looked at no reason it won't be nothing just questionable if something might be brewing; just going to do a biopsy of uterus because of ultrasound need to be looked at again. Arthritis was definitely what caused the knee surgeries. Very active gone on to have a full life radio program curates the art in her town. Does her own grocery shopping. Lives alone since husband died. Patient tested her for genetics relative to breast cancer she is not passing anything on to her daughter of the female breast genes don't think it goes any further. Patient does not take a lot in the past she had very serious lyme disease; no real relapse in that last 10 years; before that she spent 10 years in treatment for lyme disease so she could go back to that. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Concomitant medication(s) included celecoxib (CELEBREX) taken for pain, start and stop date were not reported; thyroid (ARMOUR THYROID) taken for thyroid disorder from 2001 to an unspecified stop date. The patient experienced pain in her pelvis on 31Jan2021, same pain feeling in bladder and pelvis on an unspecified date, sore arm on an unspecified date, had pain that was just in the knee replacements, where knee replacements on unspecified date, pain on 31Jan2021, standing up feels weird on 28Jan2021.This is report 1 of 8. The patient who reported pain standing up feels weird and sore arm after first dose of Pfizer Covid-19 Vaccine. Pain on the 3rd day after the first dose of Pfizer Covid-19 Vaccine she woke with pain in her pelvis and thought she had a urinary tract-captured as provided as only urinary tract- which she doesn't usually have. Then on the 4th day after first dose of Pfizer Covid-19 Vaccine she had the same pain feeling in bladder and pelvis. She was seeing a cancer doctor that day for a 6-month check-up who ran a urine sample, and it was negative. She knew it was negative because that symptom was pretty intense on 3rd and 4th day but then it was gone. The pain took her all the way back to when she had the knee replacement surgeries; she was on Morphine then which she can't do that now; they wouldn't give it to her. She had using Advil and some Celebrex which she was not supposed to use those because of her heart condition which was under control. Advil and Celebrex taken for the pain have done nothing for the pain they are doing nothing they don't touch the pain. Her family doctor suggested she try marijuana. her cancer doctor was trying to get her medical marijuana; but nothing's happened in 6-8 weeks. Pain was making her crazy, did buy the marijuana it comes like candy like little gummy bears to try to alleviate the pain that way but did not get the medical marijuana. The oncologist talked to his secretary and she was told they would contact her in 6 weeks. 6 weeks went by and they haven't contacted her. The Oncologist texted her she told him she hasn't gotten the medical marijuana card yet and you have to pay for the card. So her daughter in Massachusetts can buy marijuana that's legal there-so the patient tried little bit of a gummy bear which did nothing for the pain; so she tried a little more of a gummy bear which still did nothing for the pain; then another day she tried a whole gummy bear which still did nothing for the pain in her knees but she felt kind of fogged up in the head, after 6 days after the first dose of Pfizer Covid-19 Vaccine she woke up with both knees that she had a knee replacement in in 2014; and she had basically gotten over most of it; the 6th day after the shot she woke up and had pain that was just in the knee replacements where knee replacements both were. It was excruciating pain it woke her up and she has been pretty bad ever since. That was the most extreme day of pain was 6 days after the first dose of Pfizer Covid-19 Vaccine. It was pretty bad and then it woke her up 10May2021 also. For the pain Advil doesn't touch it she has taken 600mg of Advil every day which she was not allowed to take because she had 2 stents in her heart during heart surgery performed in 2020. They don't really want you to take Advil or anything after that. She's pretty much suffering and was probably going to end up in pain management. She got the second dose of Pfizer Covid-19 Vaccine and that second dose didn't make any difference did not worsen or affect events. She has to use a walker now; she had really gotten pretty much through that major surgery 5 years ago the double knee replacement surgery which she verified as being in 2014. She never got really great, but she could walk without a cane or any assistance. 09May2021 she when went to the cemetery to spread her deceased husband's ashes and had to use 2 canes so the pain definitely came from the Pfizer Covid-19 Vaccine. The patient reporting adverse events with Pfizer Covid-19 Vaccine. Mentioned she has been using Advil and some Celebrex taken for pain which have done nothing for the pain they are doing nothing they don't touch the pain. Advil expiry: Jul2023 Lot: WJ22828 UPC/NDC was Unknown on top over the code they use when they do inventory or all. Patient has friends with hip replacements and knee replacements, and no one was saying anything about pain with their replacements. She was thinking the Pfizer Covid-19 Vaccine was just attacking the foreign particles in her body which are the knee replacements. Celebrex: Lot/NDC/Expiry: Unknown dispensed in pharmacy vial. The outcome of the event pain in her pelvis was recovering, same pain feeling in bladder and pelvis, sore arm, had pain that was just in the knee replacements, where knee replacements was unknown, pain was recovering, standing up feels weird was recovered on unspecified date. No follow-up attempts are needed. No further information is expected
78 2021-07-26 difficulty speaking Prior to March 21, 2021 patient was able to walk on her own (although pace was slow), get in and out... Read more
Prior to March 21, 2021 patient was able to walk on her own (although pace was slow), get in and out of bed or chairs, able to dress herself, use the toilet and shower and communicate verbally (although voice was not very loud. She received the second Pfizer/BioNTech COVID-19 vaccine 2:30 PM on March 18, 2021; on March 21, 2021 she had gotten up at 4:00 AM and was walking through the kitchen when she found herself on her back on the floor and was unable to get up. She required help in getting up and has not been able to walk on her own ever since. She requires help in getting in and out of bed, in and out of chairs, cannot use toilet and shower on her own, is unable to dress herself and her voice has become a whis
78 2021-07-27 pain in extremity, numbness and really horrible radiating pain down both of her legs, front and back.; She also said there was n... Read more
and really horrible radiating pain down both of her legs, front and back.; She also said there was numbness in her leg; swelling in her sacrum; headache; nausea; She said she had severe joint pain; severe muscle weakness, and pain; she did not have any appetite; and had troubles staying awake.; HCP said that she also had neurological problems; had a fever of 102 for 5 days; diarrhea; dizzy; severe muscle weakness, and pain/ weakness in legs; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; This is a spontaneous report from a contactable other HCP (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 2 via an unspecified route of administration on 09Jun2021 (Batch/Lot Number: EW0182; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Borderline multiple myeloma (Borderline Multiple myeloma for 10-15 years), ongoing Monoclonal gammopathy, covid-19 from Mar2020, Severe allergies, ongoing having a lot of immunology problems going on/ immunocompromised, sarcoidosis from 1970, Russian flu, 5 episodes of anaphylaxis, had 9-10 episodes of total body hives, has been resuscitated twice, B cell blood malignancy, allergic to over 30 drugs and lingering COVID symptoms: dry cough, muscle and joint pain, headache, dizziness, and diarrhea. The patient's concomitant medications were not reported. Patient previous received hepatitis vaccines and TB for immunization and experienced did not respond/ nonresponsive, received Swine Flu for immunization and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173, expiry: 31Aug2021), on 19May2021 (at the age of 78-year-old) as single for COVID-19 immunisation and experienced high fever, joint pain, some weakness in her legs/severe muscle weakness, headache, nausea, she was very ill / She said she was pretty sick for 10 days, diarrhea and muscle pain. The patient experienced dizzy, and severe muscle weakness, and pain/ weakness in legs, both on 10Jun2021 with serious criteria of disability, diarrhea, and had a fever of 102 for 5 days on 10Jun2021. Her immunologist cleared her for the vaccine because she has an unsettling allergy history. He did an immunology review of her allergies and prior vaccination problems before determining if she could get the COVID vaccine. He wrote her a letter that said she had to get the vaccine in a room with an IV ready and the defibrillator ready as well. Her immunologist thought it was prudent she try the first dose. She did have COVID already in 2020. She ended up in the emergency room from the vaccine. She was reticent to get the second dose because she had barely recovered from the first dose when she was due for her second dose. The second dose reaction was different. The day she got the second dose 09Jul2021, she got home okay without problem and went to bed. When she got up in the morning she had trouble getting out of bed. She had difficulty walking. She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking (10Jun2021). She also said there was numbness in her leg, swelling in her "sacrum," and really horrible radiating pain down both of her legs, front and back. She was fine the day she received the shot, but had great difficulty getting out of bed the next day. She said she still could not drive because she was still dizzy and nauseated. She added that she had headache, nausea, and diarrhea. She said she had on and off diarrhea for 6 or 7 days, and couldn't keep anything down without having it. She said she had severe joint pain, severe muscle weakness, and pain, and had a fever of 102 for 5 days (from 10Jun2021 to 15Jun2021). On the 5th day of her having fever, she said she was struggling to put one foot in front of the other in terms of walking. She said she was also starting to feel as if she was paralyzed. She was having troubles trying to walk normally since there was weakness in her legs. She also said she did not have any appetite. She spent a lot of time in bed, sleeping, and had troubles staying awake. She said she had a bad headache. She said she called 911, and went to the hospital. She stayed there for 2 days. She said it was very unpleasant. She also had neurological problems as well such as extreme difficulty in walking, standing up, and profound leg weakness. However, she said that her neurologist assured her that it would go away within 4 to 5 weeks. She said it has already been 5 weeks since her 2nd dose, but she was still not feeling well. She was improving, but not well. She said she was physically not much better. She was having severe bilateral leg and sacral pain. Her sacrum was hot and swollen so she called the ambulance. She went to the ER because she had difficulty walking. She went to the ER. After five days of the second dose she still had a fever and trouble walking. The ER did multiple scans including a CAT scan of her abdomen and pelvis, an x-ray of her pelvis, and MRI of her upper and lower spine. She also had blood cultures and multiple lab work done. They were trying to rule out Guillain-Barre. She was in the ER for 2 days. She was very sick. The second day she was in the ER they told her she could go home. She thought it was because they were busy. No one explained to her the results of her tests or what was going on. Once her fever was done they didn't have to deal with her anymore. They sent her home when she was still sick with leg pain, trouble walking, and still had diarrhea. She was still nauseated, and was just eating jello. It is week 5 and she is really physically not much better. She can't drive because she was still dizzy and nauseated. She has leg pain, trouble sleeping, and muscle weakness in her legs. She is not recovered from the second dose. She thought she was going to die from it. It took a lot to call 911 especially as a nurse, but the numbness and pain in her legs was really severe. She had such weakness that she had trouble standing up and navigating through her apartment without falling down. She had made slight improvement. She mentioned that she had the flu back in 1988, so she felt very ill, and was in the hospital for 2 weeks. She was a long haul COVID patient who is enrolled in a long haul COVID program. She has been sick for a year and a half now since having COVID. She got COVID in Mar2020, and did not recover well. that is one of the reasons why they delayed her vaccination. She had to do prednisone during that time, and had to wait 6 weeks after completing the Prednisone to get the vaccine. Her baseline was a subnormal temperature of 96.1 because of her immunology issue. So 102 is really high for her. She had lingering COVID symptoms, and was a long haul patient. She had a cyclic problem with dry cough, muscle and joint pain, headache, dizziness, and diarrhea. She would have it bad for 7 days, and then recover a couple of days, and then it repeats itself. She couldn't drive because she was too dizzy and weak to drive. It was not safe to drive. She didn't have enough strength in legs to stop the car. She was seen by a neurologist several days after her emergency room visit. He examined her, and asked her reaction to the Pfizer vaccine. He said he had other patients with similar outcomes. She was immunocompromised . She has had borderline Multiple myeloma for 10-15 years. She has Monoclonal gammopathy, MGUS, she had it for a while. There are periods of time where her protein is elevated making her borderline for myeloma. She has had a couple rounds of prednisone to suppress the protein. She has a positive ANC. She has a multitude of issues. She was diagnosed with sarcoidosis in 1970 bust is in remission. She is tested regularly for sarcoidosis. She thinks she might be having a gallbladder attack now. In the past, she has been a non responder to vaccines. She got out of healthcare for that reason. She did not respond to hepatitis vaccines. She doesn't have NDC/lot/expiration for those vaccines. The infectious disease doctor at the time told her she shouldn't be a nurse for that reason because it put her at risk for hepatitis. She was also nonresponsive to TB. She doesn't have NDC/lot/expiration to any of the ones she has been non responsive to. Last time she was vaccinated she had Swine Flu. She was having a lot of immunology problems going on. The doctor recommended her not get a flu vaccine. It was later discovered that she was a non responder to hepatitis and TB. She has had no flu vaccine since swine flu in the 70s. In 1988 she had the flu, and was in hospital for two weeks and almost died from that. One of the doctors she worked with died from flu. He was a surgeon. He died so she thought she was going to. She barely squeezed by. She was allergic to over 30 drugs'. No information on those drugs provided. She has had 5 episodes of anaphylaxis. She had been resuscitated twice. She has had 9-10 episodes of total body hives. The COVID vaccine knocked her down to 0. She has had to cancel her last 5 weeks of life. She was homebound. She couldn't get out of bed and get dressed. When she had COVID in Mar2020, she had an antibody tested 3 months later and 6 months later that both showed no antibodies. She has a B cell blood malignancy, and the b cells pump up the immune system. So she wasn't surprised she didn't have antibodies. Events caused emergency room visit and physician office visit. The outcomes of events dizzy, severe muscle weakness, and pain/ weakness in legs, She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking, nausea, diarrhea, had a fever of 102 for 5 days were recovering while other events were unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events "dizziness and muscular pain" and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
79 2021-01-04 pain in extremity pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, ... Read more
pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, chest and back; pains radiating down right arm, chest and back; nausea; Vomiting; severe chest and back pains on right; severe chest and back pains on right; This is a spontaneous report from a contactable Other Health Professional (patient). A 79-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient medical history was not reported. Concomitant medication in two weeks included citalopram, levothyroxine, atorvastatin, anastrozol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 3rd day (21Dec2020), the patient experienced severe chest and back pains on right at time of 12:30 AM. On 4th day (22Dec2020) pains radiating down right arm, chest and back, nausea and vomiting. On 5th day (23Dec2020) pain under right arm pit, very stiff neck, pain radiating into ear. Temperature was normal. On 6th day (24Dec2020) most symptoms dissipated. On 7th day (25Dec2020) almost back to normal. No treatment received for the events. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.
79 2021-01-10 seizure like phenomena, cold extremities, unresponsive to stimuli Resident had seizure like activity followed by a vagel response with large bowel movement. Resident ... Read more
Resident had seizure like activity followed by a vagel response with large bowel movement. Resident then began to show signs of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low oxygen levels. Resident not responding to stimuli.
79 2021-01-12 weakness dizziness; weakness; nausea; diarrhea; This is a spontaneous report from a contactable consumer (pat... Read more
dizziness; weakness; nausea; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient non-pregnant received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13246), via an unspecified route of administration on 06Jan2021 13:00 at single dose in right arm for covid-19 immunization. Medical history included arthritis. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination was reported as yes. The patient experienced dizziness, weakness, nausea, diarrhea on 07Jan2021. The patient was not received any treatment. The outcome of the events was not recovered.
79 2021-01-12 seizure Jan 1st, patient had a seizure after breakfast. Temperature was 98.5 Pulse 95. B.P. 160/70 Two hour... Read more
Jan 1st, patient had a seizure after breakfast. Temperature was 98.5 Pulse 95. B.P. 160/70 Two hours later another seizure at the home, with emesis, Sent to hospital at 2pm. Focal Status elepticus. Seizure activity along with continuous persistent activity with emesis throughout the 12 hour time in the ED. Seizure during the CT scan.
79 2021-01-14 tremor Started getting headache within minutes of shot. Bad body aches for about 12 hours. Everything a... Read more
Started getting headache within minutes of shot. Bad body aches for about 12 hours. Everything ached and couldn't get comfortable to sit, stand, lay down. Stomach cramps that doubled me over lasted for a few hours. Last 4 hours could barely walk. Husband had to help walk me to the bathroom. Chills and shaking and could not warm up after the 1st hour through the rest of the night! Everything started going away about 1:00 in the afternoon and felt better at 2:00.
79 2021-01-17 feeling cold, pain in extremity muscle pains-runs down left leg/thigh, chills, arm pain soreness after vaccination along with itchin... Read more
muscle pains-runs down left leg/thigh, chills, arm pain soreness after vaccination along with itching, frequent urination
79 2021-01-17 feeling cold She is still freezing to death; Sick as a dog; Fever; Chills; cannot eat and have no appetite; nause... Read more
She is still freezing to death; Sick as a dog; Fever; Chills; cannot eat and have no appetite; nauseous; This is a spontaneous report from a contactable nurse (patient). A 79-year-old female patient received first dose of bnt162b2 (also reported as Pfizer Covid vaccine, lot number: EK4176), intramuscular into left arm on 05Jan2021 16:00 at single dose indicated as presentation because she is a nurse/Covid-19 immunization. Medical history included Type 2 Diabetes, about 2 years ago in 2019 in which she takes metformin 1,000mg twice daily. Concomitant medication included metformin on unspecified date at 1,000mg twice daily for Type 2 Diabetes. There was no history of all previous immunization with the Pfizer vaccine nor there were additional vaccines administered on same date of the Pfizer Covid vaccine. The patient received the Pfizer COVID vaccine last Tuesday and since 06Jan2021 at 06:00, she has been sick as a dog. She is running a fever, has chills, can't eat and has no appetite because she is nauseous; all on 06Jan2021 at 06:00. This is the third day of it. She would like to know what she can she do. She said that it all started Wednesday morning when she got up. It just gets worse every day. It looks like it would get better by now, but it hasn't. She never runs a temperature, but she has now (unspecified date). She is still freezing to death on unspecified date. She usually has a good appetite. Even the thought of food makes her sick. She further reported that she has had nothing but chills, fever, and nausea and states it will not go away. She is treating it with ibuprofen. She confirms she already talked to a nurse in this department to report this and she was transferred to see what she could do and states they never answered. This is her first dose and she does not know if she should get the second dose. The patient can't calm down since she has been sick since last Wednesday. She stated that she needed some help because she is so sick. She was suggested to call again calling Pfizer medical information department. She stated that she had called back three times, but there is no such number. The events sick as a dog, fever, chills, can't eat and has no appetite, and nauseous were considered serious (Other medically important condition). The outcome of the events sick as a dog, fever, chills, can't eat and has no appetite, and nauseous was not recovered, and the outcome of the remaining event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completed based on known safety profile and a compatible temporal relation between vaccination and onset of events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
79 2021-01-19 pain in extremity Sore arm
79 2021-01-20 pain in extremity Swollen right index finger and joint. Quite painful - most pain is subsided but swelling is still t... Read more
Swollen right index finger and joint. Quite painful - most pain is subsided but swelling is still there on joint.
79 2021-01-21 flushing Within 5 minutes of receiving the vaccine, my heart started racing, my blood pressure shot up to 190... Read more
Within 5 minutes of receiving the vaccine, my heart started racing, my blood pressure shot up to 190 over ? (Usually my BP is low normal), my face was very flushed.
79 2021-01-25 pain in extremity patient presented to her primary care for evaluation of leg pain. Noted on US that patient had a DVT... Read more
patient presented to her primary care for evaluation of leg pain. Noted on US that patient had a DVT in Left distal superficial femoral and popliteal veins. patient was hospitalized for treatment as patient had recent diagnosis of GI bleed and would need close monitoring of blood thinning medications. Of note- patient is 1/3 hospitalized with cardiac/blood issues currently in this facility who received a vaccine from this pharmacy in the last month and all three patients have the same COVID vaccine lot number. Physician elected to have a VAERS put in on all patients to ensure investigation was properly handled.
79 2021-01-25 tremor Irregular heart rate pretty severe for a couple of hours then I had chills and enough to make my tee... Read more
Irregular heart rate pretty severe for a couple of hours then I had chills and enough to make my teeth clatter and also dry heave for some hours until I took the medicine under the tongue and it got better. I still have shaking in my hands and feet as well.
79 2021-01-25 tremor At night headaches started and lasted all night and they were all over my head, just like I was wear... Read more
At night headaches started and lasted all night and they were all over my head, just like I was wearing a helmet. I also had 2 days of beinf lethargic and sleepy. Still feel tired. I recovered from everything except the trembling and the fatigue.
79 2021-01-26 tingling, flushing, numbness Numbness and tingling sensation on right side of the body (leg, arm, back) Flushing in the face High... Read more
Numbness and tingling sensation on right side of the body (leg, arm, back) Flushing in the face Higher than normal blood pressure Sensations started earlier in the day on Saturday. On Sunday at 1pm, she went to the hospital and the symptoms stayed until 6pm. She was sent home from the hospital with diagnoses of parasthesia and numbness. Sensations started again earlier today, Wednesday the 27th. Called the doctor and said there isn't much they can do because they don't know much about the vaccine.
79 2021-01-26 tingling Shortly after vaccination, patient developed dizziness and tingling sensation along jawline. Patien... Read more
Shortly after vaccination, patient developed dizziness and tingling sensation along jawline. Patient mildly hypertensive. Approximately 15 minutes later, dizziness developed but tingling sensation also experienced in bilateral feet. Evaluated in ER and ultimately sent home without further complication.
79 2021-01-27 mild one side paralysis, slurring Patient presented to hospital 1 day following vaccination with slurred speech, left sided weakness, ... Read more
Patient presented to hospital 1 day following vaccination with slurred speech, left sided weakness, and left gaze preference concerning for acute neurologic injury.
79 2021-01-27 tremor, pain in extremity slept all day; very sore arm; woke up trembling with chills; terrible chills; headache/bad headache;... Read more
slept all day; very sore arm; woke up trembling with chills; terrible chills; headache/bad headache; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included major reaction to eating conch, and tested positive for COVID on 22Nov2020 There were no concomitant medications. Patient read that was not a good thing to do, to get the vaccine after only 2 months instead of 3 from diagnoses. When she had COVID she had major headache, chills, and diarrhea. After the vaccine she had had the same thing, terrible chills, bad headache and diarrhea on Jan2021. The side effects say that this was normal but she wants to know should she have waited the 90 days before getting the vaccine. Patient still had the headache and chills but she took an Imodium and the diarrhea was better. Patient had also fatigue in Jan2021,and slept all day yesterday (13Jan2021). She has had a very sore arm and at 2am she woke up trembling with chills on Jan2021. Outcome of the event chills and headache was not recovered, for diarrhea was recovering and for the remaining events was unknown. Patient had a major reaction to eating conch and wanted to make sure there was no shellfish involve in the vaccine. Information on the batch/lot number has been requested.
79 2021-01-28 muscle spasms, pain in extremity Vaccine at 11:;50 am. 9:30 pm severe pain in left leg with cramps. then right leg but not as severe... Read more
Vaccine at 11:;50 am. 9:30 pm severe pain in left leg with cramps. then right leg but not as severe. pain all night, no sleep. Next day, severe pain back, upper left started about 4:30pm. then pain all over, muscular. lasted al night. Better next morning but still muscular pain.
79 2021-01-29 pain in extremity Fatigue, sore arm, redness, began last night.
79 2021-01-30 weakness Ran 100 and 99 for 2 days, and had chills, also a little weak.... started at 3pm on the 28 and conti... Read more
Ran 100 and 99 for 2 days, and had chills, also a little weak.... started at 3pm on the 28 and continued thru the 29th. Finally normal temp. on the 30th.
79 2021-01-30 seizure Seated playing cards. Sudden onset extreme dizziness, short seizure, blacked out X 1-2 seconds Other... Read more
Seated playing cards. Sudden onset extreme dizziness, short seizure, blacked out X 1-2 seconds Other player called 911. One fire truck followed shortly by one ambulance both with two very cute EMTs. All vital signs normal. Very similar to dehydration attacks but worse and that always followed rising and walking. This attack worse and was not set off ambulating. Worried about a worse effect after second vaccine.
79 2021-01-31 weakness Dizzy and light headed, mild nausea, weak and tired with occasional shortness of breath. Elevated bl... Read more
Dizzy and light headed, mild nausea, weak and tired with occasional shortness of breath. Elevated blood pressure causing headaches. I have been unable to send this via the phone/text. I am exhausted from this continued distress. Normally very active and healthy.
79 2021-01-31 feeling hot Client reported warm feeling to face and neck, lightheadedness 3 minutes after receiving the vaccine... Read more
Client reported warm feeling to face and neck, lightheadedness 3 minutes after receiving the vaccine Care initiated by facility. Vital signs within normal range. Client declined further treatment.
79 2021-02-01 numbness and pain in extremities, numbness Difficulty in walking / could not walk; her feet feel like they are numb; Dementia; This is a sponta... Read more
Difficulty in walking / could not walk; her feet feel like they are numb; Dementia; This is a spontaneous report from a contactable consumer (patient). This 79 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1284) in left arm, on 18Jan2021 at 12:00 PM or 01:00 PM, for COVID-19 immunisation. Medical history included pacemaker (she just had it checked on 18Jan2021 at the cardiologist and they said it was good for five more years), heart issue, dementia (before getting the vaccine). Concomitant medications were none. On an unspecified date in Jan2021 the patient experienced dementia (she had a bit of dementia right now, which she also had before getting the vaccine) and her feet felt like they were numb, like neuropathy (maybe she had that, it had never been checked). Since 19Jan2021 the patient could not walk, had difficulty in walking. She was using a cane as she did not want to fall, she weighed 200 lbs and her partner would never be able to get her up if she fell. She was able to walk with the cane. The patient said that there had been no other treatment for her difficulty in walking and it seemed to get better. The initial caller (patient's partner) said she had the shot too on 18Jan2021 and did not have those symptoms, she was not the one who was sick, she did not know what else was going on in her partner's body, they did not think the shot caused it. The patient said she was supposed to be on a sleep apnea machine but she could not get in to the doctor to get the machine checked, it needed a test to be rechecked but they could not get in to do it because of everything that is going on. The patient was scheduled to get the second dose on 08Feb2021 at 10:00AM. Difficulty in walking was improving. The other events outcome was unknown.
79 2021-02-01 pain in extremity Arm pain to shoulder, chills, flu kind symptoms. Body ache.
79 2021-02-02 tremor, weakness Weakness, shaking, dizzy
79 2021-02-03 weakness, tremor 79 yo female with past medical history only significant for endovascular coiling of cerebral aneurys... Read more
79 yo female with past medical history only significant for endovascular coiling of cerebral aneurysms over 30 years ago presenting with fevers, fatigue, weakness, noise sensitivity, myalgias,and tremors. She exercises regularly and has become so weak that she cannot climb stairs. Neurological exam revealed hyperreflexia, subtle proximal muscle weakness, the presence of a startle reflex and rooting reflex, clonus, and a positive Babinski. Infectious work up has been negative, autoimmune evaluation is underway. Inpatient neurology consultation has been obtained, she was given a trial of diazepam for stiff person syndrome and started on daily IVIG on 2/3/2021 for a 5 day course. She continues to have an elevated CRP, a mild transaminitis, and mild thrombocytopenia. The ESR dropped from 44 to 20 with hydration. She has had no cognitive changes. No headache, visual changes, jaw pain. We are unable to obtain MRI given the presence of these coils which are not MRI compatible. Encephalitis immune antibodies are pending, myositis panel, MOG antibodies ADEM are pending, GAD65 antibody pending.
79 2021-02-03 flushing This vaccine clinic was held at the Center in on 1/23/21 and hosted by the Hospital.. Vaccine admin... Read more
This vaccine clinic was held at the Center in on 1/23/21 and hosted by the Hospital.. Vaccine administered at 1340 by LPN. Patient with immediate c/o of feeling light headed, hot all over, flushed. Patient stated she felt better but at 1357 c/o of itching all over body and tongue swelling. Epinephrine pen administered at 1358 by LPN. Emergency services contacted. Patient transported to ER at approximately 1410.
79 2021-02-04 difficulty speaking diarrhea; sore abdomen/ abdominal pain; reflux; aches/pains; her voice is grabbly; has a sore throat... Read more
diarrhea; sore abdomen/ abdominal pain; reflux; aches/pains; her voice is grabbly; has a sore throat; painful esophagus; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 05:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient receive the vaccine Covid vaccine and had no problems. The next day on 16Jan2021, she had aches and pains but found them not unusual. 24 hours later that she had reflux on 17Jan2021. She had reflux all day on 17Jan20210 and took Gaviscon all day. Patient had very serious reflux Monday (18Jan2021) morning and took Prilosec. She also had a sore abdomen/ abdominal pain and took four Gaviscon that evening. She had diarrhea and stated that the same thing happened Tuesday (19Jan2021) but she was little better in the afternoon. She had no Gaviscon then. On Wednesday (20Jan2021), she very bad reflux all day, sore abdomen and diarrhea. Patient took Prilosec in the morning one hour before eating and took Gaviscon all night. Her voice was grabbly and she has sore a throat, painful esophagus and abdomen on Jan2021. She felt better the morning of 21Jan20221 and had Prilosec. She still has diarrhea and loose stool, and felt better after going to the bathroom. Her healthcare provider and the nurse stated to keep taking Prilosec. Patient wanted to know if this may be a side effect though not very prominent that is out there but not very common. Outcome of the event of diarrhea was not recovered while for the remaining events was unknown. Information on the lot/batch number has been requested.
79 2021-02-04 pain in extremity Left arm got a little sore; This is a spontaneous report from a contactable consumer (patient). A 79... Read more
Left arm got a little sore; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982), via an unspecified route of administration on left arm on 19Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing high blood pressure, had had all her life. There were no concomitant medications. The patient experienced left arm got a little sore on 20Jan2021. She went for her second dose by 10Feb2021. The patient did not receive any treatment from event. The outcome of event was recovered on 20Jan2021.
79 2021-02-04 tenderness injection site pain, subsiding as of 3 days later; upper arm tenderness, continuing ; entire arm no... Read more
injection site pain, subsiding as of 3 days later; upper arm tenderness, continuing ; entire arm noticeably swollen down into hand, still present.
79 2021-02-05 inability to speak Pt began experiencing feeling "short of breath" pt is double masked. Pt removed mask and did a coupl... Read more
Pt began experiencing feeling "short of breath" pt is double masked. Pt removed mask and did a couple deep breaths and felt slight improvement but s/s returned. Offered and pt accepted cold water, alleviating feeling short of breath. 5 pm pt began feeling more short of breath and was breathless w/speech. Nurse alert called and PO benadryl 25 mg in 10 ml PO given lot c13e exp 3/21. Vitals taken 145/745 56 HR and 95 O2. Pt taken to advanced urgent care by staff via wheelchair 507 pm
79 2021-02-06 pain in extremity, feeling cold Sore arm 3 days. Fever and exhaustion 2nd day extremely cold. Felt similar to when I had Covid but w... Read more
Sore arm 3 days. Fever and exhaustion 2nd day extremely cold. Felt similar to when I had Covid but worse. 3rd day still tired but other symptoms gone.
79 2021-02-07 pain in extremity, hot flush Arm got a tad sore; makes her tired; Nausea; Chills; Hot flash; This is a spontaneous report from a ... Read more
Arm got a tad sore; makes her tired; Nausea; Chills; Hot flash; This is a spontaneous report from a contactable nurse via the Pfizer-sponsored program Pfizer First Connect. A 79-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on 13Jan2021 at a single dose for covid-19 immunization. Medical history included gastroparesis. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), mirtazapine, calcium, colecalciferol (VITAMIN D). It was reported that the patient got the vaccine on the 13Jan2021. Wednesday and Thursday night, she was fine. On Friday (15Jan2021), she started getting nausea and chills. Then Saturday she was ok again. Then Sunday the nausea came back. She had had nausea since then. It comes in waves. When it is kind of mild, she doesn't feel so bad. This morning it has been bad. It makes her tired when the nausea gets like this. It may subside during the day. When she firsts get nausea, she gets hot flash. The patient's arm got a tad sore, but only a little. The outcome of the event chills was recovered on an unspecified date, nausea was not recovered while unknown for the other event.
79 2021-02-07 pain in extremity heavy sweat; night of shot arm hurt so bad I could not sleep, arm still sore; night of shot arm hurt... Read more
heavy sweat; night of shot arm hurt so bad I could not sleep, arm still sore; night of shot arm hurt so bad I could not sleep; achy; chills; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 19Jan2021 10:30 AM at single dose for COVID-19 immunisation. Vaccine location was Left arm. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Patient was allergies to penicillin, keflex lisinopril and Spiriva Respimat. Other medical history included asthma and heart electrical problem. Concomitant medications the patient received within 2 weeks of vaccination included many for asthma and heart etc. Patient administered the most recent COVID-19 vaccine at Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced shot arm hurt so bad and she could not sleep became achy and chills in the night of 19Jan2021, slept deeply Wed (20Jan2021) and Thursday (21Jan2021) nights. The patient experienced heavy sweat in the night of 21Jan2021 (Thursday) bedclothes very wet in morning Friday (22Jan2021) feel better but arm still sore. Patient was not received treatment for the adverse events. The outcome of events reported as recovering. All events reported as non-serious: adverse event resulted in none of seriousness criteria.
79 2021-02-08 feeling hot About 30 minutes after the shot, sudden very weird feeling, visual distortion, confusion, disoriente... Read more
About 30 minutes after the shot, sudden very weird feeling, visual distortion, confusion, disoriented (now believe was sudden drop in blood pressure), followed by mouth feeling odd, tongue felt too big, difficult to swallow, followed by sensation of intense heat. This all lasted about 5-10 minutes. Resolved on its own. Felt a little shaken but OK afterwards.
79 2021-02-09 feeling cold I had no issues with the first dose. When they gave the 2nd dose, I felt strange feeling in my arm. ... Read more
I had no issues with the first dose. When they gave the 2nd dose, I felt strange feeling in my arm. I felt fine after that until the night. About 8PM I got a bad headache, I was so cold all over and I could not get warm, My blood pressure was 153/93. Body aches all over. My skin be sensitive it felt like it hurt to touch my skin. I couldn't sleep last night and was up and down all night. Today I still got a headache. I have been taking Tylenol which didn't help and tried Excedrin. I feel very tired today but I was awake a lot last night. I still have the chills as well.
79 2021-02-09 feeling hot Loose stools; stomach ache; body became hot up to her head then red haze seen in room/Body became ho... Read more
Loose stools; stomach ache; body became hot up to her head then red haze seen in room/Body became hot like a hot flash again; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at Left arm on 21Jan2021 15:45 at SINGLE DOSE for COVID-19 immunization. The patient was not pregnant. Medical history included high blood pressure, arthritis, known allergies: sulfa drugs, dust, mold. Concomitant medication included atenolol, atorvastatin, lactobacillus nos (CULTURELLE), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon dioxide, sodium metavanadate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc (CENTRUM SILVER ADULTS 50+). No other vaccine in four weeks. The patient's body became hot up to her head then red haze seen in room on first day 21Jan2021 07:00 PM. Body became hot like a hot flash again, no color haze on the second day (22Jan2021). Loose stools and stomach ache on third day (23Jan2021). No treatment received for the events. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the events was recovered in Jan2021.
79 2021-02-10 involuntary muscle movements, muscle twitching, seizure At 1207, resident was noted having facial twitching and seizures and crackles , Vitals: BP 199/95, O... Read more
At 1207, resident was noted having facial twitching and seizures and crackles , Vitals: BP 199/95, O2 Sats 89% on RA, PR 88, Temp 97.3, RR was hardly counted because of body movement. Blood sugar was 172 mg/dL. Hooked on O2 at 4L per NC. Informed MD and ordered to send to ER. Family - were updated. Ambulance was called. Family clarified resident's status is DNR. Report was given to ER nurse. Updated ER that INR today is 5.5 and MD ordered to HOLD Coumadin till 02-11-21.
79 2021-02-10 numbness 45 minutes after injection the left side of my face became numb to half of my tongue BP was higher ... Read more
45 minutes after injection the left side of my face became numb to half of my tongue BP was higher than normal 177/97! Numbness lasted about 45 minutes! BP was back to normal the next morning! 2/9/2021
79 2021-02-10 pain in extremity, tenderness Extremely tender, sore and swollen arm, very sore throat, 101+ temperature and sleepiness & fatigue
79 2021-02-11 weakness, pain in extremity pt started to feel pain in arm, so bad she could not use arm, no energy
79 2021-02-11 weakness Chills and fever. It was only 99.8 and then later in the day it did go to 100.3 and nausea. Weakness... Read more
Chills and fever. It was only 99.8 and then later in the day it did go to 100.3 and nausea. Weakness.
79 2021-02-11 weakness Chills and fever. It was only 99 and later in the day it was 99.5 and nausea. Weakness.
79 2021-02-12 tremor Shaking chills and then fever to 100.7 3.5 days after administration.
79 2021-02-14 burning sensation Burning sensation on skin on Feet on Back; Burning sensation on skin on Feet on Back; Burning sensat... Read more
Burning sensation on skin on Feet on Back; Burning sensation on skin on Feet on Back; Burning sensation on skin on Feet on Back; This is a spontaneous report from a contactable 79-year-old female consumer (patient). A 79-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration in left arm on 28Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included embolism in 2012 and cardiac pacemaker insertion in 2019. Concomitant medication included warfarin (unknown manufacturer), levothyroxine sodium (THYROXIN) and lisinopril (unknown manufacturer). The patient previously took lidocaine and ciprofloxacin and experienced drug hypersensitivity. The patient previously received the first dose of bnt162b2 for covid-19 immunisation and experienced four small raspberry type "burn" left arm and small taste in mouth. The patient experienced burning sensation on skin on feet on back on 28Jan2021 with outcome of recovering. The patient was not treated for the event. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112990 Same reporter/patient/drug, different events
79 2021-02-14 numbness Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Sys... Read more
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild
79 2021-02-16 seizure like phenomena, weakness, tremor 4 seizure type episodes (including shaking, eyes rolling back for about 15-30 seconds long) after be... Read more
4 seizure type episodes (including shaking, eyes rolling back for about 15-30 seconds long) after being moved out of bed - lasted 4 days Fever up to 102.5 - lasted 5 days Could not stand - 8 days Body aches - 8 days Could not walk - 9 days Weakness - on going since vaccine Shaking - on going since vaccine
79 2021-02-17 facial paralysis Drooping of left cheek; Elevated blood pressure; nodes in neck enlarged; sore to touch; headache; Th... Read more
Drooping of left cheek; Elevated blood pressure; nodes in neck enlarged; sore to touch; headache; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiration date was not reported), via an unspecified route of administration on 28Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included allergies and known allergies to sulfa drugs. Patient was not pregnant at the time of vaccination. Concomitant medication included ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION), iron, colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN). The patient previously took first dose of bnt162b2 on 07Jan2021 09:45 on the left arm for COVID-19 immunization. The patient experienced elevated blood pressure, all nodes in neck enlarged and sore to touch, drooping of left cheek and headache on 29Jan2021 22:00. Condition persisted for 4 days. The patient received an unspecified treatment. The patient had a visit to the doctor and emergency room. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events at the time of the report.
79 2021-02-17 facial paralysis may have had a mini stroke; Bell's Palsy/developed facial drooping/her eye was drooping; fell; This ... Read more
may have had a mini stroke; Bell's Palsy/developed facial drooping/her eye was drooping; fell; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (BNT162B2, Pfizer COVID-19 Vaccine; Batch/lot number: EL9262), via an unspecified route of administration injection to right upper arm on 22Jan2021 14:00 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing she was a fainter (She was a fainter, she just faints so she has a hard time getting shots. Pfizer COVID-19 Vaccine administered to her by nurse while she was in her car seat. She just asked the nurse to let her lay down in the car seat when injection was administered so that if she fainted she would not fall far; she was still getting the wash cloth on her head preparing when the Nurse had already finished administering the injection.); ongoing depressed sometimes (she was depressed sometimes, was stressed. She was the primary caregiver for her 96 year old mother. She had seen something about stress and COVID and shots and everything); ongoing Very tired (She was almost 80 years old so she was very tired often. She was the primary caregiver for her 96 year old mother. By the time she comes home at night around 21:30 she was just wiped.); Obesity (She was really overweight but she did not like the term obesity.); thyroid disorder; hypertension; Cataract and glaucoma in left eye; family history of ongoing facial paralysis (Dad had Bell's palsy that might have been 30 years ago. He died at age 87 years.); diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes). Concomitant medication included Levothyroxine at 100mcg taken once daily in the morning early before she eats with Start date unknown, but at least 10-15 years ago for Thyroid. Enalapril at 10mg taken once daily (Caller initially reported product name as Vasotec, but clarified it is not Vasotec, it is drop for eye cataract and glaucoma) for High blood pressure. Brimonidine with Strength unknown, 1 drop in both eyes twice daily, started maybe 1 year ago. Specified cataract and glaucoma in left eye; but drop was administered to both eyes; and left eye was eye affected by Bell's palsy for Cataract and glaucoma in left eye. The patient previously took codeine and experienced allergy with onset maybe about 50 years ago, she was not sure; occurred during dental procedure; had bad headaches but no lasting effects so they assumed allergy to codeine; she did not know if still has allergy but says she does if asked. The patient experienced bell's palsy/developed facial drooping/her eye was drooping on 29Jan2021 with outcome of recovering, may have had a mini stroke on an unspecified date with outcome of unknown , fell on 27Jan2021 with outcome of unknown (reported date of end of reaction was 27Jan2021), she could not blink that eye on 29Jan2021 with outcome of not recovered. Five days later she fell and developed facial drooping. HCP suggested she may have had a mini stroke causing facial drooping and the fall. She went to the ER on 29Jan2021 and the ER believed it was Bell's Palsy. She was still experiencing facial symptoms but they are improving. This consumer was administered her first dose if Pfizer COVID-19 Vaccine 22Jan2021. She reported having fell 27Jan2021. She was diagnosed with Bell's palsy in 29Jan2021 after having been seen in the emergency room. She is supposed to have the second dose/booster of Pfizer COVID-19 Vaccine on 12Feb2021. She called to ask if she should or should not still get the second dose as scheduled; and if Bell's palsy could be a reaction to the Pfizer COVID-19 Vaccine. The emergency room staff did not know how she got Bell's palsy, but knew she had the Pfizer COIVD-19 Vaccine and were kind of assuming the Bell's palsy was a reaction to the vaccine. She dis not have Bell's palsy bad. The emergency room staff thought at first she had a stroke before diagnosing her with Bell's palsy. On Wednesday, 27Jan2021 she had a friend named (Name withheld) who came over for tea. Patient has an oriental rug, and around 15:00 patient fell face first on oriental rug. She was just fine after the fall initially. She wonders if her having fell has anything to do with the Bell's palsy. She thinks it was the night of 27Jan2021 or 28Jan2021 when she asked her son if her face looked funny, did she look ok, because her face felt a little funny. She was looking in the mirror and her smile was looking crooked, and her eye looked like it was drooping. When she got up Friday, 29Jan2021 she could see her eye was drooping, and she could not blink that eye. She called her Ophthalmologist who saw her the afternoon of 29Jan2021 around 13:30-13:55. The Ophthalmologist said yeah something is going on with that eye. Her friend called his friend who is a Pediatric Neurologist that advised her to go to the emergency room. She was seen in the emergency room of (Hospital name withheld) around 17:00 on 29Jan2021. She was not admitted to the hospital at that time; but was evaluated and treated. She Bell's palsy outcome: she is doing so much better. She still has a hard time blinking her left eye, she still cannot blink her bad eye: left eye, without also closing her good eye: right eye. She is not drooling, she can drink without drooling. Her smile is still just a little crooked. She was given 2 prescriptions in the emergency room which were Prednisone and Valtrex. On 29Jan2021 in the emergency room they did tests including testing her heart with EKG; X-ray of her heart or lungs or something; took blood tests; and continuously took her blood pressure. There were no notable or abnormal results of any of those tests. They wanted her to go see her doctor last week but she did not have a chance to do so. She has an appointment with her primary doctor on Monday coming up. She has not yet seen her primary doctor about this. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None. The event Bell's palsy require a visit to Emergency Room, no to Physician Office. The patient was not hospitalized. No Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient underwent lab tests which included her heart with EKG; X-ray of her heart or lungs or something; took blood tests; and continuously took her blood pressure, all with no notable or abnormal results of any of those tests on 29Jan2021.
79 2021-02-17 feeling cold, tremor Awaken during night shaking, cold, and body aches
79 2021-02-17 pain in extremity I received my vaccine on Sunday, work up Monday with sore arm which I expected. Monday night around ... Read more
I received my vaccine on Sunday, work up Monday with sore arm which I expected. Monday night around 9pm I had a fever 101.3, my normal pain lever increased bad, and my balance of worse than normal, to walk 20 yards I had to stop at least 5 times because my back was hurting so bad. The next day, I woke up with normal fever but there was redness on the injection site a little larger than a silver dollar, around 8 my fever went up to 100. The next night, Wednesday night my fever was at 99.6, the next day my temp was normal and continued to be the rest of the time. The redness on my arm started fading and has continued to fade but I can still see where it is.
79 2021-02-18 weakness, cold extremities, muscle spasms The night of the vaccination, I experienced icy cold hands and feet throughout the night. I had to ... Read more
The night of the vaccination, I experienced icy cold hands and feet throughout the night. I had to get up twice to put additional blankets on the bed, even though the house was heated as usual. I also experienced frequent muscle spasms and cramps in both legs throughout the night. The following day, Feb 18, 2021 and today, Feb 19, 2021 I have been very low on energy, simply sat all day. Experienced lower than usual blood pressure (98/84 w/ 127 heart rate, 89/71 w/ 77 heart rate. Currently feeling normal at 4:25 pm.
79 2021-02-18 flushing, feeling hot Rapid heart rate , hot, stinging, flushed facial skin Unsteadiness, lightheadedness
79 2021-02-18 tremor, feeling hot Involuntary shudders I had no control over that lasted 4-5 minutes that left me gasping for my breat... Read more
Involuntary shudders I had no control over that lasted 4-5 minutes that left me gasping for my breath. Left arm is quite red and very warm. I was down all day Wednesday & most of Thursday. It so happened that I had a scheduled appointment with my cardiologist on Thursday and checked ok
79 2021-02-19 tremor Severe chills with abrupt onset 21.5 hours post second dose, accompanied by fever of 102.3 F by ora... Read more
Severe chills with abrupt onset 21.5 hours post second dose, accompanied by fever of 102.3 F by oral digital thermometer. She was shaking uncontrollably while dressed, wrapped in a blanket, and sitting in warm room within two feet of fire in fireplace and using hand warmers. Symptoms lasted approximately 75 minutes.
79 2021-02-21 difficulty speaking to ER on 2/19/21 breathing difficulty, hoarse voice , chest pain, skin itchy, headache, edema, body... Read more
to ER on 2/19/21 breathing difficulty, hoarse voice , chest pain, skin itchy, headache, edema, body joint pain, elevated B/P
79 2021-02-21 pain in extremity After two days, had sore arm, sore shoulder and neck. 4 days after very tired,, and felt like had fl... Read more
After two days, had sore arm, sore shoulder and neck. 4 days after very tired,, and felt like had flu for 5 days. Had rash on left arm ob 6 day, still tired but better. 7 day ok.
79 2021-02-21 pain in extremity PAIN IN BOTH ARMS, CHILLS, WHOLE BODY ACHED
79 2021-02-21 cold extremities Redness on the thighs, legs, and chest. very little redness on my arm(s). I was watching tv 3 days a... Read more
Redness on the thighs, legs, and chest. very little redness on my arm(s). I was watching tv 3 days after receiving the vaccine and my palms were suddenly blue and I could see every vein in my hands and fingers. they were cold and color returned after submerging them in warm water.
79 2021-02-23 flushing grade 2 allergic reaction; short of breathe; flushed; she was an oncology patient with large granula... Read more
grade 2 allergic reaction; short of breathe; flushed; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; This is a spontaneous report from a contactable other healthcare professional. A 79-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, NDC number of COVID Vaccine: 59267-1000-1; Expiry Date of COVID Vaccine: 31May2021), intramuscularly at Left Deltoid on 08Feb2021 10:30 (either 10:30AM or within that hour or prior) at single dose for COVID-19 immunization. Medical history included anxiety, panic disorder, asthma, obstructive sleep apnea, additional Information for Other Conditions: She was oxygen Dependent, coeliac disease, allergy, Additional Information for Other Conditions: She had Medication, Environmental, and Food Allergies, central neuro hearing loss, vertigo, Allergic rhinitis, gastrooesophageal reflux disease (GERD), Additional Information for Other Conditions: Esophageal Reflux, osteopenia, impaired glucose tolerance, hypothyroidism, claustrophobia, rheumatoid arthritis (she had arthritis for which she took Orencia for), history of coronary heart disease, diabetes, she would be a targeting patient, as she was an oncology patient with large granular lymphocytic leukemia she met criteria for the pandemic, as well as they put down that she was due for immunization. She had anaphylaxis to bees. With adhesive tapes she got dermatitis. With shellfish she got hives. She had a gluten sensitivity and with mango her mouth gets fuzzy. Family Medical History Relevant to AE(s): her sisters had a few cancer. There were no concomitant medications. The patient previously received levofloxacin she had hives, with quinolones drug class she had hives, with thiopental she had hives and needed IV Decadron for it, with sertraline she has syncope, with Revatio she had an adverse event of joint and muscle pain, with ciprofloxacin she had tachycardia, with Enbrel it caused a drug induced pulmonary fibrosis granulomatosis, with Montelukast she had a headache and muscle pain, nitrofurantoin she had headache, with Symbicort it gave her hoarseness, she took Orencia for arthritis, she got the flu Vaccine in Sep2020. That was most recent. The patient had a grade 2 allergic reaction on 08Feb2021. The patient was watched after administering the vaccine on 08Feb2021 as she had background of multiple allergies and asthma. She was watched for 30 minutes in the oncology unit infusion suite. The reaction happened within 5 minutes of administration. Seriousness Criteria: Caller explained that this reaction was mild to moderate, there was a grade to intervene but at no point was she unstable, she did have a significant anxiety disorder, and so she was nervous about getting the vaccine. She was short of breathe, odd and flushed. She was physically stable, her vitals were stable and there was no angioedema. Reporter seriousness for grade 2 allergic reaction: Medically significant. The patient recovered, as a treatment they gave her IV Benadryl 50mg and IV fluids, she also had her own albuterol inhaler. In the pandemic, they are not doing nebulizers. The outcome of events allergic reaction, shortness of breath and flushed was recovered on 08Feb2021. Relatedness of drug to reaction(s)/event(s). Reaction assessed: Grade 2 allergic reaction; Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related. Causality: reporter stated that she did think the patient's base line anxiety played into the reaction she experienced, the reaction was aggravated by it.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of grade 2 allergic reaction, short of breathe and flushed due to temporal relationship and current known drug safety profile. The patient's underlying allergic physique also predisposed the patient to developing the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
79 2021-02-24 weakness Patient was given the vaccine and waited the recommended time (15 minutes) after the administration ... Read more
Patient was given the vaccine and waited the recommended time (15 minutes) after the administration of the vaccine and did not report any reaction at that time. Approximately six hours after the injection, she suddenly noticed she was having trouble breathing, could not catch her breath, and a call was made to 911. She was transported via ambulance to the hospital, where she remained for a week.
79 2021-02-24 feeling cold injection site soreness, tired, chills, nausea, headache
79 2021-02-24 tremor Headache, stomach cramps, dizziness, shaking, fatique, joint pain, nausea
79 2021-02-25 weakness day after shot--fatigue, headache, body aches, no appetite, no energy
79 2021-02-25 tingling has sporadic a-fib (at baseline); She stated she was in real bad stroke territory; she felt like she... Read more
has sporadic a-fib (at baseline); She stated she was in real bad stroke territory; she felt like she was going to faint; Her blood pressure was 220/97; tingling in her hands and feet; felt like brain sizzling like it was frying/going to faint; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, first dose) solution for injection intramuscular in the left arm on 06Feb2021 at 09:30 (at the age of 79-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing sporadic A fib (atrial fibrillation) for 6 years know about; allergy to polyethylene glycol in 1985 (she had difficulty taking birth, control pills and they found out it was the coating PEG in); cerebrovascular accident prophylaxis; in 1985 She had difficulty taking birth control pills and they found out it was the coating PEG in it. She had an allergy to this where she broke out in bumps on her fingers and mouth and had itchy eyes, a full blown allergy; and when she was 45 going through menopause. Concomitant medication included apixaban (ELIQUIS) for A fib and cerebrovascular accident prophylaxis. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021, the patient had sporadic a-fib (at baseline) then put in a medical van requiring emergency room visit. The patient stated, She stated she was in real bad stroke territory, felt like she was going to faint (6 minutes after vaccination), blood pressure was 220/97, tingling in her hands (6 minutes after vaccination) and feet and felt like brain sizzling like it was frying/going to faint (6 minutes after vaccination) on 06Feb2021. Lab tests included blood pressure on an unknown date high 150s and never lower than 187, then on 06Feb2021 was 220/97, on 09Feb2021 was systolic blood pressure 180, then on 10Feb2021 had gone down. The outcome of the events atrial fibrillation and feeling unwell was recovered on 06Feb2021, after 3 hours. The outcome of the events stroke, faint and tingling of extremity was unknown. The outcome of the event blood pressure was 220/97 was recovered on 10Feb2021.
79 2021-02-26 flushing, numbness Pt developed a flushed feeling, numbness in hands and palpitations(heart racing) several minutes aft... Read more
Pt developed a flushed feeling, numbness in hands and palpitations(heart racing) several minutes after injection. Symptoms slowly subsided after 20-30 minutes of observation. HR: 100, SBP: 150, SP02: 99. EMS services/hospital evaluation was offered and pt declined. She elected to go home with her husband as the driver with a plan to self monitor at home.
79 2021-02-27 weakness Began running low grade fever next morning, by evening the temp was 100 . I had no energy an began t... Read more
Began running low grade fever next morning, by evening the temp was 100 . I had no energy an began to fall asleep in the early evening.. Woke up in a sweat. Felt exhausted all the next day but temperature left. Should be almost normal by tomorrow. I hope.
79 2021-02-27 pain in extremity, tremor Started with aching arm followed by shaking chills, fever, body aches, headache, nausea, and lasted ... Read more
Started with aching arm followed by shaking chills, fever, body aches, headache, nausea, and lasted about 24 hours.
79 2021-02-28 weakness 2/26 - severe flu symptoms (achy, no energy), drastic increase in memory related issues (has mild co... Read more
2/26 - severe flu symptoms (achy, no energy), drastic increase in memory related issues (has mild cognitive impairment) 2/28 - vomiting and diarrhea
79 2021-02-28 bell's palsy bells palsy
79 2021-02-28 cold sweat chills for 2 days, then itchy for several days, then urine burning, then nerve jumping in arms, the... Read more
chills for 2 days, then itchy for several days, then urine burning, then nerve jumping in arms, then clammy all separate in afternoons 2nd shot was 2 weeks ago
79 2021-02-28 pain in extremity 79 yr old caller had first vaccine yesterday at 1425 (pfizer) late in the afternoon she had chills a... Read more
79 yr old caller had first vaccine yesterday at 1425 (pfizer) late in the afternoon she had chills and pain in arm, mouth was sour. she hasnt been taking her potassium on large amount of diuretics for kidney and heart. she is on 2.5 mg eloquis. today she stayed in bed this am her temp was 100. an hour ago it was 101.3 adv apap for fever if ok with your medical situation, sx are normal for vaccine. ok to go for dr next week if f/u is needed. these sx are not contagious.
79 2021-02-28 pain in extremity pain in the injection site and arm/pain at injection site all the way to her elbow; pain in the inje... Read more
pain in the injection site and arm/pain at injection site all the way to her elbow; pain in the injection site and arm/pain at injection site all the way to her elbow; felt like someone stuck a knife in her muscle; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number A3249 and expiry date unknown, via unspecified route of administration at the left arm on 21Jan2021 at single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications included other medications. The patient had the first dose of the Pfizer vaccine on 21Jan2021 and the following day (22Jan2021), she experienced pain in the injection site and arm. The patient informed that it felt like someone stuck a knife in her muscle. The patient informed that the pain was improving and not sure if she wanted to get the second dose. The patient informed that she had a dental procedure done and was taking pain medication to help with that but it didn't help with her pain in her arm from the shot. The patient has been having pain at injection site all the way to her elbow. The patient informed that the first day they it was like she had a shot. The patient informed that it felt like a knife was being stuck in her muscle the second day (22Jan2021). The patient informed that today it felt like pressure. The patient informed that at night time that she sleeps perfect and when she gets up in the morning that it was bad pain. The patient informed that she was leery about getting her second shot. The patient informed that she had two teeth pulled on Friday (unspecified date) after she got the vaccine. The patient informed that they redid her partial for those teeth. The patient informed that they had prescribed 800 mg of ibuprofen for her teeth. The patient stated that she thought it would help the pain in her arm but it did not. The patient was told to keep taking it but she stopped. The patient informed that she has to take antibiotics for her teeth until they were all gone. Therapeutic measures was received by the patient due to the events. The outcome of the events was recovering.
79 2021-02-28 pain in extremity I experienced throat congestion:a feeling of thickness and swelling.; I experienced throat congestio... Read more
I experienced throat congestion:a feeling of thickness and swelling.; I experienced throat congestion:a feeling of thickness and swelling.; higher temp; arm ache; This is a spontaneous report from a contactable consumer for herself. A 79-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on 30Jan2021 14:30 (Lot number: EL9264) via an unspecified route of administration in the right arm at single dose for COVID-19 Immunization. The patient's medical history included cholesterol but not high. The patient had no known allergies to medications, food, or other products. The patients concomitant medication included rosuvastatin at 5mg, aspirin (acetylsalicylic acid) at 81mg. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The dose was received at 2:25pm. The dose was received on adverse event start date: 30Jan2021 at 2:25pm. patient waited the 15 minutes waiting period & went home. 95 minutes after (30Jan2021 16:00 PM) the injection she experienced throat congestion: a feeling of thickness and swelling. The symptoms lasted 35 minutes. Other reactions were normal: higher temp & arm ache. There was no treatment received for the adverse events. The outcome of the events was recovered on 30Jan2021 16:35. No follow-up attempts are possible. No further information is expected.
79 2021-03-01 bell's palsy, facial paralysis Second dose of Covid vaccine given on 2/7/21. Administered at central location. Taken to hospital fo... Read more
Second dose of Covid vaccine given on 2/7/21. Administered at central location. Taken to hospital for possible stroke like symptoms with drooping to right eye and mouth, difficulty swallowing, and feeling odd. Admitted and treated from 2/18/21 thru 2/22/21.
79 2021-03-01 burning sensation headache, tingling in throat and tongue, sneezing, fatigue, burning sensation in knees, memory issue... Read more
headache, tingling in throat and tongue, sneezing, fatigue, burning sensation in knees, memory issues
79 2021-03-01 involuntary muscle movements Teeth has protruded outward and felt like something was in her throat.
79 2021-03-01 pain in extremity pt stated that she had a sore arm and trouble sleeping. Pt contacted her PCP about not being able t... Read more
pt stated that she had a sore arm and trouble sleeping. Pt contacted her PCP about not being able to sleep so she was given a RX for Trazodone 50mg but pt is concerned about taking it due to the side affects.
79 2021-03-01 pain in extremity tingling lips, itchy red cheeks - on the way home Saturday muscle aches from neck to ankles - during... Read more
tingling lips, itchy red cheeks - on the way home Saturday muscle aches from neck to ankles - during the night Saturday to Sunday stuffy nose, dry cough, fatigue, chills (no fever), nausea, sore arm - Sunday and Monday on third day the only thing remaining are chills sought no treatment
79 2021-03-01 tingling, numbness, numbness and pain in extremities, burning sensation Shot was on 2/15. No adverse until about 9 pm on 2/19 when started having. Neuropathy in feet, legs ... Read more
Shot was on 2/15. No adverse until about 9 pm on 2/19 when started having. Neuropathy in feet, legs and mouth started to burn. This burning and tingling has happened every night since. Was hoping would clear up on its own. Had some neuropathy before but nothing like this. Went to Dr on 3/1. This was first appointment. I could get. He did number of tests should hear from them soon. At the present time of typing this I have some tingling and burning and numbness. But is extremely bad at night
79 2021-03-02 weakness Patient presented with bilateral ptosis and weakness in the jaw while chewing that progressively get... Read more
Patient presented with bilateral ptosis and weakness in the jaw while chewing that progressively gets worse as the day goes on. Patient was prescribed pyridostigmine bromide 60 mg with improvement of symptoms. Patient is following up with neurology.
79 2021-03-02 numbness, tingling Had a Herpes Simplex virus that was dormant unless I get excited; Got the vaccine; First reaction wa... Read more
Had a Herpes Simplex virus that was dormant unless I get excited; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; My heart felt like rush; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Have Covid tongue; symptoms got progressively worse; feeling just kind of bumped out; This is a spontaneous report from a consumer (the patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809), via an unspecified route of administration on 10Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization. Medical history included cholesterol. Concomitant medication included rosuvastatin calcium (CRESTOR). The patient previously took Aspirin (e.c.) about 10-15 years ago and experienced anaphylactic reaction, Lyrica about 10-15 years ago for neuralgia and experienced hypersensitivity. The patient reported that on 10Feb2021, she got the vaccine. When she first obtained the vaccine, she was put in a holding situation in regards to having any reaction. She was sitting there about 10-15 minutes, and the first reaction was a numbing on left side of her face and her eye, her jaw and then her left arm was tingling, then she developed a taste of metal in her mouth; had a very salty taste along with the metal taste in her mouth; her mouth became dry. Her heart felt like rush. The "EMT" guy was there, he watched her. So, she sat there for a while. She went home and her symptoms got progressively worse. It was almost an immediate reaction. She started to get an ache in her left eye/pressure in her eye, and feeling just kind of bumped out. Immediately, after she got the vaccine, she had a very salty taste along with the metal taste in my mouth. When I came home, my mouth became dry. The patient reported that she still have a salty taste in her mouth and have "Covid tongue". The patient also reported that she had a herpes simplex virus that was dormant unless she get excited and it has been down for a long period of time. The patient reported that "I am afraid to take my second dose". The patient did not receive treatment for the events. She stated " I just thought it would go away". The clinical outcome of the event salty taste in her mouth was not recovered. The clinical outcome of the remaining events was unknown.
79 2021-03-02 pain in extremity She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vacc... Read more
She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine/She does have rheumatoid arthritis in right shoulder and arm; right shoulder and right arm felt sore and achy/ right arm and shoulder were aching; right shoulder and right arm felt sore and achy/ right arm and shoulder were aching; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number: EN6201), intramuscular at upper left arm on 17Feb2021 10:15 at a single dose for COVID-19 immunization. Medical history included ongoing Rheumatoid arthritis (arthritis in right shoulder and arm gets inflamed and sore; rheumatoid arthritis in right shoulder and arm. It sometimes flares up and gets sore) diagnosed in late 2019, ongoing Autoimmune deficiency disease diagnosed in late 2019 and lower left eyelid which was inverted. There were no concomitant medications. No prior vaccinations (within 4 weeks). The patient previously took Shingrix vaccine (Shingles vaccine) at left arm last year-2020 and she felt soreness and achiness in right shoulder and arm. The patient received the first dose of the Pfizer COVID-19 vaccine yesterday on 17Feb2021 at her left arm. A few hours later her right shoulder and right arm felt sore and achy. On 18Feb2021, the patient's right arm and shoulder were aching. The patient mentioned that this has also happened last year when she had a Shingrix vaccine. She was also injected in her left arm but her right arm got sore and achy. She felt soreness and achiness in right shoulder and arm. She wanted to know if this is a normal reaction from the vaccine. The patient stated that it was weird. On unspecified date, when she lifts her arm up high it hurts, she stated that she does have an inflamed shoulder. She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine. During the night it was very bad. She does have rheumatoid arthritis in right shoulder and arm. It sometimes flares up and gets sore. She was wondering if there is a relationship with the COVID 19 vaccine because she felt like she got the COVID 19 vaccine in the right arm, she asked if she's reacting to the medication. No treatment was administered for right shoulder. Routine lab work done on 02Feb2021 but it has nothing to do with this. The events did not require a visit to Emergency Room or Physician Office. The patient is also scheduled to have Botox in her lower eyelid for her left eye to release the nerve muscle. She asked if it is ok since she just had the Pfizer COVID-19 vaccine. She is scheduled to get botox injection next week for lower left eyelid which is inverted, it was bothering her. They have to release the muscle by getting an injection of botox. She was receiving conflicting information from her PCP, who says wait a month and her ophthalmologist who says its ok to get the COVID 19 vaccine. She thought she heard something about not mixing botox with the vaccine. The outcome of the event "She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine/She does have rheumatoid arthritis in right shoulder and arm" was unknown; and other events was recovering.
79 2021-03-02 pain in extremity pain in her hand/ lower part of each finger hurt; joint pain in right hand; bled quite a bit; This i... Read more
pain in her hand/ lower part of each finger hurt; joint pain in right hand; bled quite a bit; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9263), intramuscular on 27Jan2021 (at the age of 79-years-old) as a single dose in the left shoulder for COVID-19 vaccination. Medical history included shoulder surgery about 10 years ago and she lost use of her thumb and index finger, the nerve comes from the shoulder; her hand might be numb and stiff, often but not every morning from an unknown date. Concomitant medications were reported as she is on medication but nothing she feels is relevant. On 03Feb2021, the patient experienced pain in her hand and all the lower part of each finger hurt for about 5-10 seconds, joint pain in her right hand lasting 10-15 seconds, it did not last very long; and she bled quite a bit stating she thinks she got it right in the vein on 27Jan2021. The pain happened about four different mornings but has not had pain "since Friday" and that was lighter sharp pain with no numbness. The clinical outcome of the event bleeding was unknown; pain in extremity and joint pain was recovered on 12Feb2021.
79 2021-03-03 inability to speak short of breath taken to ED. At home- Had aphasia after 1st dose for about 5 minutes. PCP said to g... Read more
short of breath taken to ED. At home- Had aphasia after 1st dose for about 5 minutes. PCP said to get 2nd dose
79 2021-03-03 weakness Achy body, backache, neck ache, weak, low appetite, losing weight, no energy
79 2021-03-06 difficulty speaking, feeling hot At about 4:45 AM the following day after receiving my second Covid-19 vaccine shot, I experienced a ... Read more
At about 4:45 AM the following day after receiving my second Covid-19 vaccine shot, I experienced a reaction including itchiness all over my body, redness all over my body, abdominal discomfort, diarrhea, vocal changes, lightheadedness, felt hot (but didn't have a temperature, 97.4 degrees Fahrenheit), joint pain. Took Benadryl, and symptoms resolved after about an hour.
79 2021-03-07 pain in extremity pt stated that several days later she started having trouble with her left leg, hip and foot. Pt we... Read more
pt stated that several days later she started having trouble with her left leg, hip and foot. Pt went to her PCP after she got these symptoms and they did xrays on her leg which showed no breakage. He prescribed her anti-inflammatory and pain pills. She has been applying ice to affected areas. She has been referred to an orthopedic doctor but is waiting for them to contact her. She has also been to a message therapist and a Chiropractor with no help for the pain. Pt states that the pain is not getting any better.
79 2021-03-08 pain in extremity Headache, stiff neck, left arm hurt to use it.
79 2021-03-10 pain in extremity arm swelled up/had arm swelling; little discomfort with the needle; some blood on the band-aid; felt... Read more
arm swelled up/had arm swelling; little discomfort with the needle; some blood on the band-aid; felt achy in her arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, Pfizer First Connect. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in arm in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that when she got the first dose of the vaccine in Jan2021, she felt that the needle went in, she felt a little discomfort with the needle, had some blood on the band-aid, she felt achy in her arm afterwards in Jan2021; and her arm swelled up/had arm swelling on unspecified date. She did not feel anything with the second dose and there was no swelling like the first time. She asked the nurse if it went in for the second dose and the nurse said it did. The patient mentioned that there was nothing that showed like anything went in her arm when she received the second dose. She heard that the second one should feel something going on more than first time. She did not know if she could get another vaccination or what she needed to do. Outcome of the events was unknown. Information on the lot/batch number has been requested.
79 2021-03-11 feeling cold, weakness severely cold, short of breath, exhaustion, muscle pain, nausea, fast heart rate, dizzy, weak
79 2021-03-12 facial pain, tingling, numbness Shocking and immediate onset of painful sensation on right side of face.- similar to feeling when sh... Read more
Shocking and immediate onset of painful sensation on right side of face.- similar to feeling when shots given for dental work begin to wear off. Tingling pain from hairline to mid throat, from behind ear to right side of nose. areas of numbness, , noticeable swelling of lymph node under right chin. Painful to swallow, painful to open mouth, pain in jaw like having a really bad tooth ache. this is nine days. I had a titanium tooth implant in the last six months. Painful to chew food - eat soups, ice creams, soft food like bananas.
79 2021-03-14 flushing Rash on face/It was like a bumpy rash, like little pimples but no heads on them/its erupting on the ... Read more
Rash on face/It was like a bumpy rash, like little pimples but no heads on them/its erupting on the forehead and starting there; It's really red, a red face; Red flushed face; This is a spontaneous report from a contactable nurse (Patient). A 79-year-old female patient received BNT162B2 (BNT162B2; Lot number EK4176, expiry date not reported) via an unspecified route of administration to left arm on 24Jan2021 at 14:00 single dose for covid-19 immunization. Medical history included wheelchair user (She is in a Wheel chair), amputee (she is an amputee, Right leg above the knee, known as "AKA."), leg amputation from an unknown date. There were no concomitant medications. The patient experienced rash on face/it was like a bumpy rash, like little pimples but no heads on them/its erupting on the forehead and starting there on 25Jan2021. Reporter also added it's really red, a red face on an unspecified date and red flushed face on 24Jan2021. The patient underwent lab tests and procedures which included cardiac stress test: unknown results on 22Jan2021 and Nasal Swab: negative on Nov2020 (She got tested about 8 weeks ago and it was negative/test was done end of Nov2020). Therapeutic measures were taken as a result of rash on face/it was like a bumpy rash, like little pimples but no heads on them/its erupting on the forehead and starting there, it's really red, a red face and red flushed face. Reporter stated her rash on the face started on Sunday, it's really red, a red face, it is a blotchy rash on chin, which then moved up to the cheek, and as of yesterday it is now starting on the forehead. Her first dose was on 24Jan2021 at 2pm. She clarifies that it actually started with a red flushed face mainly her cheek on Sunday 24Jan2021, then on Monday she noticed that she thought her chin was breaking out, it was more definite Monday and then faded. By Tuesday it was on her cheeks. It was more definite on Wednesday, it was like a bumpy rash, like little pimples but no heads on them. When queried Weight caller adds that she is an amputee, Right leg above the knee, known as "AKA." Her rash is getting better it goes up the face but its erupting on the forehead and starting there. Caller clarifies it is about the just in different locations on the face. She put cortisone on it. On Friday 22Jan2021, she actually did go for a cardiac stress test, in which they gave her something, radioactive, some medication, since she can't do the stress test running on the treadmill. She has had No Positive Covid test. She got tested about 8 weeks ago and it was negative, it was done via a Nasal Swab, she recalls she got tested prior to a procedure, and so the test was done end of Nov2020. She is in a Wheel chair. The outcome of the event Rash on face/It was like a bumpy rash, like little pimples but no heads on them/its erupting on the forehead and starting there was not recovered. Outcome of all the other events was unknown.
79 2021-03-14 pain in extremity On my right leg down close to the ankle I have a swelling that is showing bruising and a lump that i... Read more
On my right leg down close to the ankle I have a swelling that is showing bruising and a lump that is painful. I am not sure if it is a clot or not. I have not been to Urgent care . I informed people giving me vaccine I was on blood thinners. Nobody seem to show concern about that. I have already received 2nd shot, which I got very sick after, but symptoms seem to happen to others. My concern is the lump on my leg if it is a clot and concern if I will get more now that I took the 2nd vaccine.
79 2021-03-14 pain in extremity Headache and sore arm; Headache and sore arm; This is a spontaneous report from a contactable consum... Read more
Headache and sore arm; Headache and sore arm; This is a spontaneous report from a contactable consumer (patient) reported that a 79-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: unknown), via an unspecified route of administration on 03Feb2021 at single dose for covid-19 immunization. The patient's medical history included Hypertension, Osteopenia and Prediabetes. Concomitant medication was not reported. Patient has not tested positive for COVID-19 since having the vaccine (03Feb2021). On 04Feb2021, the patient experienced Headache and sore arm, for which Tylenol was given as treatment. The outcome of the event Headache and sore arm was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
79 2021-03-14 tingling, numbness, nerve injury No immediate common listed side effects. Periodic tingling, deadness in arm. Phoned the Clinic whe... Read more
No immediate common listed side effects. Periodic tingling, deadness in arm. Phoned the Clinic where vaccine was administered. Was told that there was a possibility that a nerve was hit. Have scheduled an appointment with my primary physician.
79 2021-03-15 bell's palsy sore throat, followed by headache and right ear pain. Nausea and fever of 101.0 on March 8th, in add... Read more
sore throat, followed by headache and right ear pain. Nausea and fever of 101.0 on March 8th, in addition to previous symptoms. In the emergency department on March 11th with complete right facial droop consistent with Bell's palsy; this has persisted as of today, also with evidence of right serous otitis media
79 2021-03-15 feeling hot, tremor nausea; She was just not quite herself; feeling hot and sweaty; feeling hot and sweaty; not feeling ... Read more
nausea; She was just not quite herself; feeling hot and sweaty; feeling hot and sweaty; not feeling well; shaky; nervous; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration, on 02Feb2021 12:00 at a single dose on the right arm for COVID-19 immunization. Medical history included asthma, knee surgery, and bulging disc. The patient had an MRI on an unspecified date in Jan2021 (a week and a half prior to the date of initial report) with result of bulging disc. Concomitant medications included fluticasone furoate (ARNUITY ELLIPTA) for asthma; She was supposed to take 1 puff a day. However, being in the house, she had no problems, she had maybe used it twice a week since she hasn't had any problems, she last took 1 puff on 01Feb2021). She was also taking vitamin pills concomitantly. On 04Feb2021 23:00, 2 days after the vaccine, the patient had sweats, was wringing wet, and was not feeling well. Her hair was wet, and she was sweating. She was okay on the morning of 05Feb2021 but not herself. She had a little nausea on 05Feb2021. She was just not quite herself on 05Feb2021 but doesn't have the sweats. She further reported that she had her first shot on 02Feb2021 12:00. She was fine and had no problems. However, on night of 04Feb2021, before bed, she started getting hot and sweaty, like she was wringing wet. She didn't feel good, but 2 days had gone by and she was fine. She also went to bed with something like chills (later clarified as not chills), she went to sleep on the morning of 05Feb2021 and felt okay but not that great. When queried when the chills started, she said that it was not really chills, she was just very sweaty, wringing wet. She stated that she never sweats, and in this case her whole hair was wet. Being older, she was wondering what was going. Her feeling hot and sweaty subsided during the night. She did start to feel nausea, or she thought maybe she hasn't had anything to eat and so had a half banana and then she was okay. She thought she was hungry and felt funny, she had the half banana and was okay. She also felt a little shaky and nervous on 04Feb2021; however, it all subsided after going to bed. At the date of report, 05Feb2021, she felt okay but she didn't feel completely herself. Her second dose is scheduled on 26Feb2021 at 9:15 AM. Outcome of events feeling hot and sweaty was recovered with sequel on 05Feb2021. Outcome of event not feeling well was unknown. Outcome of event nausea was recovered on 05Feb2021. Outcome of the events shaky and nervous was recovered on 04Feb2021. Outcome of she was just not quite herself was not recovered.
79 2021-03-15 muscle spasms leg cramps and tightness walking.
79 2021-03-16 weakness nausea, severe headaches and bodyaches, extreme weakness, vomit, cough, fever, chills, unable to per... Read more
nausea, severe headaches and bodyaches, extreme weakness, vomit, cough, fever, chills, unable to perform daily activities, took bonine and tylenol
79 2021-03-17 inability to speak, tremor Uncontrollable shaking, inability to walk, inability to talk, hands hot to the touch, incontinence, ... Read more
Uncontrollable shaking, inability to walk, inability to talk, hands hot to the touch, incontinence, inability or desire to eat - all began 4:30pm on the day after first vaccine given (Tuesday 2 Mar 2021) . Patient had to sleep in a reclining chair for 3 nights and was prompted to drink water and was given one Tylenol 650mg. During this time patient needed INCREASED assistance with toileting and could not have a shower with assistance (instead was given a sponge bath). Symptoms lessened over the three days and patient returned to her baseline by Saturday 6 Mar 2021.
79 2021-03-18 burning sensation Burning pain in left buttocks area, researched and thought it was a sciatica issue/Could not lay dow... Read more
Burning pain in left buttocks area, researched and thought it was a sciatica issue/Could not lay down, bend over or put weight on that leg/Pain lasted over 48 hours; Burning pain in left buttocks area, researched and thought it was a sciatica issue/Could not lay down, bend over or put weight on that leg/Pain lasted over 48 hours; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Lot number: El3247), via an unspecified route of administration, administered in Gluteus Medius Right on 31Jan2021 as single dose for an unspecified indication. Medical history included AFib, sleep apnoea, high cholesterol and drug allergy to Sulfa. Concomitant medications included apixaban (ELIQUIS), diltiazem (trade name not reported), atorvastatin (trade name not reported), paracetamol (TYLENOL) and melatonin (trade name not reported). The patient previously took atropine and experienced drug hypersensitivity. The patient experienced burning pain in left buttocks area, researched and thought it was a sciatica issue. Could not lay down, bend over or put weight on that leg. Used alternately ice and heat. No fever. Pain lasted over 48 hours on 31Jan2021 16:00. The outcome of the event was recovering.
79 2021-03-19 flushing 03/14, face flushed. 03/15, felt as if I was hit by the flu: chilled, aching, sore throat, feeling e... Read more
03/14, face flushed. 03/15, felt as if I was hit by the flu: chilled, aching, sore throat, feeling exhausted. 03/16 no sore throat but "dizzy," off-balance all day in addition to other symptoms. 03/17, not feeling chilled but still feeling slightly "dizzy" (off-balance) all day with mild aching and still feeling tired. 03/18, virtually all symptoms disappeared.
79 2021-03-20 feeling cold blood sugar raised up; being unbelievably freezing cold; This is a spontaneous report from a contact... Read more
blood sugar raised up; being unbelievably freezing cold; This is a spontaneous report from a contactable consumer (patient self). A 79-year-old female patient received the second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 09Feb2021 10:30 (Lot number was reported as ELO1265 or EL01265, the patient was not sure if the third digit was letter or number; unknown why this Lot was 7 digits when first dose Lot was 6 digits) at the age of 79 years old, at single dose for covid-19 immunisation. Medical history included diabetes from 2018 and ongoing, family Medical History includes: All diabetics stage I and stage II, ongoing scoliosis, 60 degrees of scoliosis diagnosed when she was age 75 years; assumed it was congenital, ongoing asthma when she was around 40 years of age, ongoing thyroid disorder when she was around 45 years of age, diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, back pain, celiac disease. Concomitant medications included insulin lispro (HUMALOG) taken for diabetes from 2019 and ongoing; sitagliptin (JANUVIA) taken for diabetes from 2019 and ongoing, because of celiac disease-she cannot take others; she wondered if getting vaccine may have knocked this out of her system and it is having to build back up, prednisone taken for back pain from 27Jan2021 to 01Feb2021, She knew prednisone can increase blood sugar levels. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration, administered in arm right on 19Jan2021 14:00 at the age of 79 years old, at single dose for covid-19 immunisation, and previously took second shingles vaccine for immunization and described as a bruiser, she was really sick, the vaccination date of second shingles vaccine was reported as maybe 1.5 years before 12Feb2021. There is no other vaccination within four weeks prior to the first administration date of the suspect vaccine BNT162B2. No other vaccines were administered on same date with the BNT162B2. The patient experienced very high blood sugar levels and being unbelievably freezing cold on 10Feb2021 after she was administered the second dose. She called to ask if anyone else has reported very high blood sugar levels after getting the vaccine. Her normal blood sugar level in the mornings was about 122; normal blood sugar level in the evenings was about 180. She had not gone to physician's office, emergency room or been hospitalized for this event at this time. As long as she stayed under 300 and she was ok she knew. Blood sugar level was 164 on 10Feb2021 morning, exact time unknown, blood sugar level was 247 on 10Feb2021 evening, exact time unknown, blood sugar level was 182 on 11Feb2021 morning, exact time unknown, blood sugar level was 296 on 11Feb2021 evening, exact time unknown, blood sugar level was 172 on 12Feb2021 morning, exact time unknown. The patient had to use insulin lispro more than normal in response to very high blood sugar levels. Increased doses provided as took 13 units this morning: 12Feb2021; 14 units evening of 11Feb2021: Started with 10 units, but when got blood sugar level of 296 she took 4 more units. The patient experienced unbelievably freezing cold on 10Feb2021 about 13:00 or 13:30. She woke up around 13:00 or 13:30 and was unbelievably freezing cold. She was freezing. She wrapped up in a bathrobe, 2 blankets and her husband; took a couple of Tylenol and Benadryl and this event subsided. She recovered completely from event within about 1 hour of onset on 10Feb2021. Event described as the craziest thing. The events did not result in emergency room visit or physician office visit or hospitalized. The outcome of the event high blood sugar levels was unknown, outcome of the event unbelievably freezing cold was recovered on 10Feb2021. Information about lot/batch number has been requested.
79 2021-03-21 pain in extremity, weakness I went to the bathroom and the next thing I know was that I woke up on the bathroom floor, I passed ... Read more
I went to the bathroom and the next thing I know was that I woke up on the bathroom floor, I passed out for couple of minutes; Chills; Weak; Dizzy; Nausea; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 79-year-old, on 06Mar2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on an unspecified date, as SINGLE DOSE for covid-19 immunisation. After taking the second dose on 06Mar2021, the patient waited for half an hour and there was no problem. The patient came home no problem. In the middle of the night, the patient woke up with chills, the patient know that is one of the side effects, she was okay and not worried about it. The patient took her temperature that was normal but then couple of hours later, she went to the bathroom and the next thing she knew was that she woke up on the bathroom floor, the patient passed out for couple of minutes. Then she went to bed and was very weak and dizzy and nausea. The patient didn't want to call right away or did not wanted to go to the emergency room. The patient called her friend because she got very nervous and she said come back to her house. The patient took a Benadryl (treatment) and came back home and slept few hours. The patient woke up this morning, felt pretty good and took Benadryl (treatment) and then came here of her friend house and took Benadryl (treatment) again few minutes ago and four hours later. The patient had several things like these like she was dizzy and had nausea. The patient felt okay now and she doesn't want to go to emergency room and she seems to be fine now. The patient was dizzy, nausea and passed out. The patient had a chills and experience sore arm. Outcome of the events was recovered in Mar2021. Information on the lot/batch number has been requested.
79 2021-03-23 weakness, pain in extremity First and second day (1/21/2021 and 1/22/2021) after receiving vaccine: sore arm, slight fatigue. F... Read more
First and second day (1/21/2021 and 1/22/2021) after receiving vaccine: sore arm, slight fatigue. Fourth day (1/25/2021), extreme vertigo, nausea, vomiting, weakness, unable to stand. Husband called primary care physician who said I should go to ER immediately. Blood pressure elevated. Fluids administered. Chest X-ray, CT head. Morning of 1/26/2021,MRI brain w/o contrast. Later same day: MRA head, MRA head IAC w/ and w/o contrast. MRI IAC, MRV w/o contrast. Ultrasound carotid duplex bilateral. Diagnosed with Right Vestibular Schwannoma, benign, measures approximately 1.5 x 0.9 x 1 cm. Remained hospitalized until 1/27/2021 about 7:00pm. Follow-up with physician. primary care physician; (Otologist and Neurotologist,) and (Clinical Audiologist) at. Follow-up treatments will include consultations with above physicians, additional MRIs and CTs, and possible targeted radiation or surgery.
79 2021-03-23 muscle spasms, pain in extremity Stood up to go to the bathroom and could not put her right leg down; thought she was having a heart ... Read more
Stood up to go to the bathroom and could not put her right leg down; thought she was having a heart attack or a stroke or something; Fell on her right side; Cerebrovascular accident; Diarrhea; Nose running; Her calves were so sore, like having charley horse where her calf muscles were so tight it hurt; like having charley horse where her calf muscles were so tight it hurther calf muscles were so tight it hurt; her calf muscles were so tight it hurt; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 18Feb2021 (Batch/Lot Number: EN6201) as single dose for COVID-19 immunisation. Medical history included family history of glaucoma from 2019 (Her mother has Glaucoma); memory ain't that good (she puts everything on her calendar because her memory ain't that good); ongoing irregular heart beat since 2006 (periodically when she goes to the doctor they have her walk the treadmill and stuff like that); ongoing diabetes since 2011; and was allergic to Penicillin (as a kid she was bitten by a dog, she must have been about 12 years old, went to hospital they gave her a shot of penicillin, her head blew up, she looked like a monster, she went back they gave her Streptomycin). Concomitant medication(s) included brimonidine taken for glaucoma from 21Feb2021 to 01Mar2021; latanoprost taken for glaucoma; apixaban (ELIQUIS) taken for arrhythmia, and dyspnoea from 2019 and ongoing; and metoprolol taken for arrhythmia. The patient was administered with her first dose of COVID-19 vaccine on 18Feb2021. It went beautiful, she did not have any aftereffects or anything initially. On 01Mar2021, while in her own apartment she stood up to go to the bathroom and could not put her right leg down; she thought she was having a heart attack or a stroke or something and she fell on her right side. She went to the hospital where she was hospitalized overnight for observation and testing. MRI performed during that hospitalization had result of Cerebrovascular Accident-CVA. She also reported onset of diarrhea and nose running around 01Mar2021. When she went to the hospital on 01Mar2021 she was laying down, and when the doctor moved the blanket to test her legs her calves were so sore, like having charley horse where her calf muscles were so tight it hurt. The events were reported to have required a visit to the emergency room. They did not find anything else during hospitalization with testing. The only thing she can think of related to these events was the COVID-19 vaccine. She called to ask if she should or should not get the second dose of the COVID-19 vaccine as scheduled for 11Mar2021 relative to these events. She was scheduled for second dose on 11Mar2021, but she is scared because of events that occurred 01Mar2021. The outcome of the events diarrhea, "Nose running", "Her calves were so sore, like having charley horse where her calf muscles were so tight it hurt", "her calf muscles were so tight it hurt" was recovering, and for other events was unknown.
79 2021-03-25 weakness bad memory, weak, extreme nausea, hallucinating,
79 2021-03-25 weakness Initial rash on forehead after first injection. After second dose several weeks later she immediatel... Read more
Initial rash on forehead after first injection. After second dose several weeks later she immediately (next day) had hip pain and difficulty walking. It continued to worsen every day. On the 9th day after the second dose she started vomiting. Currently she has joint and muscle stiffness, extreme weakness and fatigue. She can hardly lift up her toilet seat. Her PCP started her on oral prednisone and she is now on 10mg qod.
79 2021-03-28 weakness Very severe malaise, nausea, lack of appetite, weakness, urinary frequency (every 15 min x 2 days - ... Read more
Very severe malaise, nausea, lack of appetite, weakness, urinary frequency (every 15 min x 2 days - urine totally colorless though I was not drinkiing anything, yellow tint gradually reappeared over next 3 days), no fever, memory and concentration much worse than usual, could not even think well, joint pain ,prolonged excessive sleepiness (nearly has resolved after 2 weeks)
79 2021-03-29 weakness Headache; very sore joints; so weak had trouble walking; so weak had trouble walking; went to bed ni... Read more
Headache; very sore joints; so weak had trouble walking; so weak had trouble walking; went to bed night of vaccine didn't get up till Sat morning; This is a spontaneous report from a contactable consumer (patient). A 79-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Unknown), dose 2 via an unspecified route of administration, administered in right arm, on 25Feb2021 at 12:15pm (at the age of 79 years old) as single dose, for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as Public Health Clinic/Veterans Administration. Medical history included allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was receiving other medications within 2 weeks of vaccination however they were not provided. The patient received dose 1 of BNT162b2 (Lot number EL-9262) in right arm. The patient did not receive any other vaccines within 4 weeks prior to the BNT162b2 vaccine. On 25Feb2021 at 18:00 (6:00pm), the patient experienced headache, very sore joints, so weak had trouble walking and "went to bed night of vaccine didn't get up till sat morning". Treatment was not received for the events. Since the vaccination, the patient has not been tested for COVID-19. The clinical outcome of the events headache, very sore joints, so weak had trouble walking and "went to bed night of vaccine didn't get up till sat morning" was recovering. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, were not provided and will be requested during follow up.
79 2021-03-29 mild one side paralysis, numbness Stroke / hospital observation/weak left side, numbness/
79 2021-03-29 pain in extremity Very sore arm. Achey joints muscles, extreme fatigue, stiff neck, "fuzzy" thinking. Most gone afte... Read more
Very sore arm. Achey joints muscles, extreme fatigue, stiff neck, "fuzzy" thinking. Most gone after one day. Arm still a little sore.
79 2021-03-29 pain in extremity sore arm, all muscles ached, wierd, dreams couldn't sleep
79 2021-03-30 weakness not feeling well, weak; not feeling well, weak; freezing/chills; aches and pains; Nauseated; This is... Read more
not feeling well, weak; not feeling well, weak; freezing/chills; aches and pains; Nauseated; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), Pfizer Covid vaccine manufacturer; unspecified, NDC number, expiry date; unknown, intramuscularly from 26Jan2021 at 12:45 pm to 26Jan2021 at 12:45 pm at single dose on left arm, towards the shoulder up high for prevent Covid. Vaccination facility type; hospital, Vaccine was not administered at military facility. Patient was 79 years old, weight; 77.11 kg, height; 155 cm at the time of vaccination. Patient medical history, relevant tests and concomitant medications were reported as none. Past drug event included soreness with flu shot (drug name unspecified). Patient did not have name, lot, ndc, or expiration date for the flu shot. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available, additional Vaccines Administered on Same Date of the Pfizer Suspect and prior Vaccinations (within 4 weeks) were reported as none. Patient experienced not feeling well, weak, freezing/chills, aches and pains and nauseated from 26Jan2021 at 12: 45 pm to ongoing. Patient got her Pfizer Covid vaccine on on 26Jan2021 at 12:45 pm, Tuesday afternoon. She has not been feeling well since then. She was freezing, she had the chills, aches and pains, she is really kind of nauseated. Nausea is the most irritating thing right now and it seems like chills have gone away. She asked how long does this last and is there anything she should be done. Advised to contact hcp, HCP: no email. All her symptoms started Tuesday night. She has had to stay covered up all the time. She feels kind of weak, and she has been laying around covered up, states that could make her sore since she is not up and doing anything. She is not throwing up, she is queasy, she does not want to eat anything like she is afraid. Patient declined any treatment given. The reported adverse event did not require a visit to emergency room or physician office. The outcome of events was recovering for chills and not recovered (From 26Jan2021 to ongoing) for other events . Investigation assessment; no.
79 2021-03-30 pain in extremity, tingling Pain in my legs; I developed really bad pain in my legs and one leg is black and blue like all black... Read more
Pain in my legs; I developed really bad pain in my legs and one leg is black and blue like all black and blue bruise; Left leg is all bruised; It is all swollen and black and blue and it is like I had tingling going from the ankle bone up to kind of half way in to my calves; Left leg is all bruised; It is all swollen and black and blue and it is like I had tingling going from the ankle bone up to kind of half way in to my calves; there is a little nodule; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6198) via an unspecified route of administration, at the age of 79-year-old, on 18Feb2021, as SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included losartan. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: not reported) on an unspecified date, as SINGLE DOSE for covid-19 immunisation and did not have any reaction. On an unspecified date in 2021, like the last week or so, the patient had some pain in legs. The left leg is all bruised and the patient did not hit it, the patient did not remember hitting it but it is all swollen and black and blue and it is like the patient had tingling going from the ankle bone up to kind of half way in to calves. The right leg it is like the ball, the top of it is all kind of shiny and swollen and it is very painful. The patient did not have that before. The patient clarified almost all over the side of legs where the bone is and like to the toes and above the ankle, it is like there is a little nodule that is little sore and same thing is on the right leg. But on right leg, the patient can barely put any weight on it. The left leg tingles and its tender, like the patient have tingling above the ankle up to like half way in to the leg. The patient would like to know if it is possible to have blood clots from the vaccine, it actually looks like a little nodule. The patient underwent MRI on an unspecified date with unknown result. The patient did not receive treatment in response to the events. Outcome of the events was unknown.
79 2021-03-30 pain in extremity Arm hurt; Chills; Fever; Aches; This is a spontaneous report from a contactable consumer (patient). ... Read more
Arm hurt; Chills; Fever; Aches; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of bnt162b2 (BNT162B2, Pfizer/Biontech Covid-19 Vaccine) via an unspecified route of administration, administered in Arm Left on 09Feb2021 14:00 (Lot Number: EN6201) at single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing (Hospital for Covid: Apr2019 - 05May2020), pneumonia from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, Pfizer/Biontech Covid-19 Vaccine, lot number: EJ1686) via an unspecified route of administration, on 19Jan202110:00 AM at single dose for covid-19 immunization and Past drug reaction included night of shot arm hurt so bad I could not sleep, arm still sore, achy, chills, heavy sweat from 19Jan2021 with no Admission to hospital due to event , no treatment received and outcome of recovered. The patient experienced arm hurt on an unspecified date with outcome of unknown , chills on an unspecified date with outcome of unknown, fever on an unspecified date with outcome of unknown, aches on an unspecified date with outcome of unknown. Vaccination facility type was senior Independent Living. No vaccine administered at Military facility. There is no other product(s) that were taken together with those indicated above. The clinical course was reported as follows: Second shot on 09Feb2021 was a lot worse. Arm hurt but not as bad as first shot. Chills, fever, aches a lot worse. 36 hours very bad.
79 2021-03-30 pain in extremity Patient began having symptoms of pain in upper R leg on 3/16/21. Presented to ER on 3/20/21 and was ... Read more
Patient began having symptoms of pain in upper R leg on 3/16/21. Presented to ER on 3/20/21 and was discharged on lovenox. Presented back on 3/21/21 after venous duplex - now being treated with Eliquis.
79 2021-03-30 pain in extremity mild "sore arm"; This is a spontaneous report from a contactable consumer. This consumer reported fo... Read more
mild "sore arm"; This is a spontaneous report from a contactable consumer. This consumer reported for a 79-year-old female patient that she received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. Medical history included hypothyroidism and hypertension from an unknown date and unknown if ongoing. Patient reported a mild sore arm starting one day after receiving the Pfizer Covid vaccination (morning of 04Feb2021). The event is ongoing at the time of reporting. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was reported as not recovered. Information about lot/batch number has been requested.
79 2021-04-01 pain in extremity severe pain, swelling of Right DIP joint right index finger, thumb and wrist. Acute onset. No fever.... Read more
severe pain, swelling of Right DIP joint right index finger, thumb and wrist. Acute onset. No fever. Responded to 400 mg oral ibuprofen.
79 2021-04-01 tremor Starting the day after receiving the vaccine, I was so exhausted that I could barely get out of bed.... Read more
Starting the day after receiving the vaccine, I was so exhausted that I could barely get out of bed. This was accompanied by trembling, especially in the upper body. This exhaustion and trembling has continued, with some remissions, through today, seven days later.
79 2021-04-02 pain in extremity Skin bright red from neck down to below buttocks back and front; Down both arms; Very lethargic the ... Read more
Skin bright red from neck down to below buttocks back and front; Down both arms; Very lethargic the entire day; This is a spontaneous report from a contactable consumer or other health care professional (patient herself) of 79-years-old female non pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810, Expiration number: not reported) via an unspecified route of administration on 04Feb2021 14:45 (at the age of 79-years) in left arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was not known to allergies. Prior to vaccination, the patient was diagnosed with COVID-19. Post vaccination the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Feb2021, patient experienced skin bright red from neck down to below buttocks back and front, down both arms and patient felt very lethargic entire the day. No therapeutic measures were taken for the events occurred. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.
79 2021-04-03 pain in extremity my arm is a little bit sore; shivering; I was so cold; I ached all over; I am getting the flu; I cou... Read more
my arm is a little bit sore; shivering; I was so cold; I ached all over; I am getting the flu; I could not walk, it was like I was drunk; pulse rate was like 116; O2 stat was like 98 percent; headache; diarrhea; short of breath when I walk up to the stairs; blood pressure, it was 66 over 48/my pressure came up to 80 over 62 or something/pressure came up to like about 103/my pressure was like 120, the systolic was 120 and diastolic was like 70 something/my pressure was in the 90's; This is a spontaneous report from a contactable Nurse (Patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration on 12Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included High cholesterol. Concomitant medication(s) included rosuvastatin (40, not clarified further); aspirin [acetylsalicylic acid] (ASPIRIN) (81, not clarified further); zinc (50, not clarified further); alendronate sodium (Generic Fosamax) and Multivitamin. Historical Vaccine included First dose of BNT162B2 on 22Jan2021 for COVID-19 immunisation and experienced sore arm (The sore arm went away, it descended in about 12 hours and gracely went away), got really tired and itching (It started itching, okay no problem). The patient experienced my arm is a little bit sore on an unspecified date, shivering on an unspecified date, I was so cold on an unspecified date, I ached all over on an unspecified date, I am getting the flu on an unspecified date, I could not walk, it was like I was drunk on an unspecified date, pulse rate was like 116 on an unspecified date, O2 stat was like 98 percent on an unspecified date, headache on an unspecified date, diarrhea on an unspecified date, short of breath when I walk up to the stairs on an unspecified date, blood pressure, it was 66 over 48/my pressure came up to 80 over 62 or something/pressure came up to like about 103/my pressure was like 120, the systolic was 120 and diastolic was like 70 something/my pressure was in the 90's on an unspecified date; all (non-serious). Reporter (Nurse) stated "I had my first Pfizer vaccine on Friday, I think 22Jan2021 and the only thing I have was the sore arm and got really tired okay and the sore arm went away, it descended in about 12 hours and gracely went away, after that it started itching, okay no problem. I had my second vaccine this past Friday at about 8 O'clock between 8:15 in the morning. As the day went on I felt my arm is a little bit sore, no problem. Okay I went to bed and about 3 O'clock in the morning, I woke up and I was shivering, I was so cold and I ached all over and I said okay I am getting the flu, went back to sleep, by the time I got up in the morning about 6 o'clock the aching was gone but I could not walk, it was like I was drunk. I have a little dog and she was barking to go out and it was like 0 here so I sat there for a minute and I left her out and she started barking, to bring her back and I could not walk, I kept walking into the walls and my house was just this dark, I thought it's so dark in my house so I got my little dog back in, sat down and again and I thought what, maybe I will take my blood pressure, so I did and it was 66 over 48 so I though okay, so I started drinking, I thought I got to eat, I got to drink, so I get that, my pressure came up to 80 over 62 or something, my pulse rate was like 116, my O2 stat was like 98 percent so that was not a problem. So, I ate and drink, as the day went on the pressure came up to like about 103, gradually last night by the time I went to bed, the only thing I had was a little bit of headache, I did not thought enough to take anything for, when I went to bed, my pressure was like 120, the systolic was 120 and diastolic was like 70 something, this morning when I got up my pressure was in the 90's. I was not taking any blood pressure medication, I mean I have but doctor took me off long time ago, I did not I mean I have no aches, I have no pains, I have nothing just a little bit of headache, not even enough to bother me, every now and then I think about it, I also, I mean I thought I have got to the bathroom, I had diarrhea terribly, something, I did not know if any of this is from the vaccine. I have not called my primary, I thought I called him tomorrow I mean I am fine, I am little short of breath when I walk up to the stairs but that is nothing unusual." Causality: Reporter stated "I don't know, I am thinking it does I never had anything like this before but you know I don't know, I don' know, I am just reporting it, I am 79 so I don't know how much this is, I don't know." When probed from where reporter got the vaccine, Reporter stated "I got it the first one at (Institute name)." LOT# of COVID-19 Vaccine administered on 22Jan2021: Reporter stated "You know it's not on my little card, just the LOT# of second one is on here. The first vaccine was 22Jan2021, the second one was 12Feb2021." Reporter provided the LOT# as EM9809 for second shot of COVID-19 Vaccine administered on 12Feb2021 and did not have LOT# of the first vaccine administered on 22Jan2021. Date of side effects: Reporter stated "I think when I started having difficulty was the morning of 13Feb2021." (Not clarified further). Still experiencing side effects: Reporter stated, "No, finally last, I felt yesterday I felt like I kind of had the flu, I have got to get the flu, but it was not enough to stop me, I kept going, I went to work, I did all my stuff, this morning I got up I felt fine." (Not clarified further). Treatment: Reporter stated: No, did not take anything, no. Other medications: Reporter stated "the generic 10 mg." (Not clarified further). Reporter stated "No I was just going to report this, like I said I don't know if this is a problem or not. I have never had anything like this before, I thought this is something you needed to know." Reason of delay: Daily spike of incoming calls due to COVID-19 Vaccine. The outcome of all events was unknown except for event I ached all over, outcome was recovered on an unspecified date.
79 2021-04-06 burning sensation, tremor Developed shakes a few days after shot. Broke out with Shingles on 28/29 of March. Started medi... Read more
Developed shakes a few days after shot. Broke out with Shingles on 28/29 of March. Started medicine (IC VALACYCLOV-IR 1 Gram every 12 hours for 10 days) on 4/3/2021 from Doctor. Rash starting to clear up on 4/5/21. Still burning slightly on 4/7/21.
79 2021-04-07 numbness right hand started to feel like it was going to sleep; This is a spontaneous report from a contactab... Read more
right hand started to feel like it was going to sleep; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot Number: EN5318; Expiration Date: 31May2021) as single dose for covid-19 immunisation. Medical history included ongoing breast cancer it has been in remission for 3 years , milk allergy, ongoing high blood Pressure, ongoing cholesterol, ongoing Diabetic. The patient historical vaccine included flu shot for immunization. Concomitant medication included lovastatin at 40 mg, twice a day taken for cholesterol, Ongoing metformin at 500 mg, twice a day taken for diabetic,amlodipine besylate;benazepril at once a day (10-40mg once a day) for high blood pressure from an unspecified start date and ongoing, vitamin d (Lot number: 507530-01 and expiration date: Oct2023) at 800 iU (takes two 400IU); ascorbic acid (VITAMIN C Lot number: 526680-01 and expiration date Sep2024) taken 1000 mg (takes two 500mg to make 1000mg) for an unspecified indication, start and stop date were not reported; cyanocobalamin (B12-VITAMIN Lot number: 505721-03 and expiration date: MAR-2023) taken 500 mg, daily for an unspecified indication, and multivitamin. He noticed one hour after receiving the first dose of the vaccine his right hand started falling asleep. It occur only in the arm where he got the vaccine. It got better and five minutes later it happened again. Caller wants to if this side effect is associated with the vaccine. The outcome of the event was unknown
79 2021-04-07 pain in extremity 03-26-2021 patient developed LLE pain, progressively worsened. Admitted to hospital on 03/29 and dis... Read more
03-26-2021 patient developed LLE pain, progressively worsened. Admitted to hospital on 03/29 and discharged 04/01. Pt diagnosed with superficial femoral artery occlusion and popliteal artery thrombosis. Left femoral artery stent placed 03/31/2021.
79 2021-04-09 weakness left arm soreness; Lack of energy; This is a spontaneous report from a contactable consumer (patient... Read more
left arm soreness; Lack of energy; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received second dose of bnt162b2 (BNT162B2 Pfizer-BioNTech COVID-19 Vaccine; Solution for injection), via an unspecified route of administration on 11Feb2021 as single dose for covid-19 immunization. Medical history included bronchitis and illness from Dec2019 to an unknown date. Concomitant medications were not reported. The patient experienced left arm soreness, lack of energy on an unspecified date. The reporter said that she become very ill in dec2019 while on vacation in (place name), went to walk-in clinic twice. no pneumonia though coughing, horrible wheezing, told me it was probably bronchitis. given numerous drugs, still doctoring when and returned home. more drugs. no energy for 2-3 months. had been told lots of sickness in (place name) when she was there. heart and lungs checked and ok. often wondered if she had covid. woman across aside from me on plane coughed all the way to (place name). 3 days later she was sick. The outcome of the events was unknown.
79 2021-04-09 burning sensation couldn't walk straight; use a cane; Guillain-Barre syndrome; left knee and left hip were so painful;... Read more
couldn't walk straight; use a cane; Guillain-Barre syndrome; left knee and left hip were so painful; equilibrium was totally off; tired; pink blotches and a red rash on her legs; pink blotches and a red rash on her legs; didn't feel good; her legs started burning; her eyes were bloodshot with dark circles; This is a spontaneous report received from a contactable female consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:45 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation. The patient did not have any allergies to medications, food or other products. The patient did not have any relevant medical history. Concomitant medications includes: Plavix (CLOPIDOGREL BISULFATE) 75mg, once a day, Oral, Losartan 100mg, 1/day, Oral for blood pressure high, toprol XL (METOPROLOL SUCCINATE) 50mg, 1/day, Oral for Blood pressure high, ezetimibe (ZETIA) 10mg, once a day for , Oral for High cholesterol. Vitamin C (ASCORBIC ACID) 1000mg, 1/day, Oral. Omega 3 1000mg, 1/day, Oral, taking for 2 years. Vitamin D 1000IU, 1/day, Oral, taking for 6 months. Multivitamin dose unknown, 1/day, Oral. Aspirin (ACETYLSALICYLIC ACID) 81mg, 1/day, Oral. All the Concomitant medications started dates was unspecified. It was reported that Consumer states she got the first dose 11Feb2021 of the Pfizer COVID 19 vaccine at 0945AM in the right arm. Adds she had no reaction the first day. Then about three days later (14Feb2021), she noticed pink blotches and a red rash on her legs; and she didn't feel good. About five days later she called the doctor who did a blood test. No results known. The doctor put her on Prednisone and she took three doses and on Feb2021 her legs started burning so she stopped. Adds she doesn't think it had anything to dowith the Prednisone; it was the vaccine. Reports she started to have balance and coordination problems, on 25Feb2021 her left knee and left hip were so painful that she had to use a cane and could not walk straight and her equilibrium was totally off so that she was she was walking into the wall. Mentions that on 17Feb2021 she was tired, on Feb2021 other eyes were bloodshot with dark circles. Mentions she did lots of research on her phone and decided that all of her symptoms seem to relate to GBS, Guillain-Barre syndrome. Clarifies she does not know if she has GBS. She has been to the doctor again and they are telling her not to get the second dose of the shot. Mentions that pretty much everything cleared up by 1Mar2021. Additional information includes plavix was used for head and neck blockage, taking for 10 years, Losartan patient took off the water pill portion HTZ part of months ago, toprol XL taking for 13 years. Zetia taking for 8 years. Vitamin C patient taking for her immune system, taking for 3 years. Omega 3 taking for 2 years. Vitamin D was taking for 6 months. Multivitamin. Aspirin patient taking for taking for keep blood flowing since 14 years. Outcome of the events didn't feel good, couldn't walk straight and use a cane and Guillain-Barre syndrome was unknown. Outcome of the events left knee and left hip were so painful, equilibrium was totally off and recovered on 01Mar2021. Outcome of the event her legs started burning was recovered on Feb2021. Outcome of the events her eyes were bloodshot with dark circles on 04Mar2021. Additional Information has been requested/ Additional information on lot/batch number has been requested.
79 2021-04-09 pain in extremity nausea, headache, pain in MCP joints of both hand - like trigger fingers. Lasted 4 hours.
79 2021-04-10 weakness Extreme weakness and fatigue. Could not walk, could not stand, could not lift head. Had to lift he... Read more
Extreme weakness and fatigue. Could not walk, could not stand, could not lift head. Had to lift her to a portable toilet. Slow to respond. Lasted for about 3 days and then started to improve each day. Took about about 5 days to be back to pre-covid vaccination state.
79 2021-04-12 weakness she was bleeding (from the eyebrow, it broke a little bit); been laying in bed, is weak, doesn't wan... Read more
she was bleeding (from the eyebrow, it broke a little bit); been laying in bed, is weak, doesn't want to get up; she does not help herself as if she had no movement in her body; Doesn't want to eat; fell a couple of times from bed and chair; she hit her eyebrow and broke it a little bit; Weakness; This is a spontaneous report from a contactable consumer reported for a patient (his wife). A 79-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration on 25Mar2021 10:00 and first dose received on 4Mar2021 ( LOT:EN6201) both as single dose for COVID-19 immunization. Medical history included dementia. The patient's concomitant medications were not reported. Patient received her first dose within 4 weeks prior to vaccination. Patient experienced bleeding (from the eyebrow, it broke a little bit) on 25Mar2021, fell a couple of times and doesn't want to eat. On 26-MAR-2021, Patient been lying in bed, weak, doesn't want to get up, Patient was fell out of bed and she does not help herself as if she had no movement in her body. The outcome of the events she was bleeding (from the eyebrow, it broke a little bit) was unknown and the outcome of the other events was not recovered. Follow-Up (29Mar2021): New information from a contactable consumer followed: Clinical information included new events, outcome details and historical vaccine.
79 2021-04-12 numbness and pain in extremities Pfizer Covid 19 vaccine: hives/broke out in hives/received the shot on her right arm, but the hives ... Read more
Pfizer Covid 19 vaccine: hives/broke out in hives/received the shot on her right arm, but the hives spread on the left shoulder down the arm and forearm; she still has "lizard skin"; has nerve on back shoulder to side and back of arm to forearm to her thumb which is not spasming; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 30Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included allergic to penicillin and bee stings. The patient's concomitant medications were not reported. The patient previously had flu vaccine and had a flu and shingles vaccine and had shingles for 3 weeks after she took the shingles vaccine. The patient received her first vaccine on 30Jan2021. On 31Jan2021, the patient ended up in ER with hives from the vaccine. She was told that she would be given Prednisone for hives but not to take it until Monday at noon. Stated that they wanted her to wait 48 hours after vaccine before she started it because it would cut it in half. She started Prednisone 40mg on Monday and did get a few more hives on Tuesday and Wednesday. She had the shot in her right arm, and all this happened on the left side of her back. She had a patch of hive of 5x6 to 8x8 on her back and on the back of her arm by her elbow and forearm. She put apple cider vinegar on her arms, and she did not itch anymore. Someone told her that this could be shingles. She stated that she got flu vaccine and got sick with flu and she took the shingles vaccine and got shingles. She could not stand in shower with the shingles but that she can with this, so she knows that it is not the shingles. The patient did not want to take the second shot on 20Feb2021 and wanted to know what Pfizer thinks. She does like to travel and hopes to soon so she wanted to know if not taking the shot could get a stipulation if they required two shots to travel. She has nerve on back shoulder to side and back of arm to forearm to her thumb which is not spasming, but she knows that it is there which came on in the past week (2021). She was on Prednisone 40 mg for 5 days and she still had hives (though they are diminishing). The patient stated that she still has "lizard skin". She received the shot on her right arm, but the hives spread on the left shoulder down the arm and forearm where she had shingles. Her ER doctor told her not to take the second dose and her primary care physician told her to wait and think about it. She is wondering if she should receive the second dose. The outcome of the event hives was not recovered while the other events was unknown. Information on the Batch/Lot number has been requested.
79 2021-04-13 numbness, tingling She has been noticing tingling involving all her extremities, initially intermittently and now progr... Read more
She has been noticing tingling involving all her extremities, initially intermittently and now progressing to constant numbness/tingling, after the second shot of COVID 19 vaccine . Symptoms started may be a few days after the 2nd COVID 19 vaccine.
79 2021-04-16 difficulty speaking confusion, skin rash, lower lip swelling, hoarseness
79 2021-04-16 pain in extremity Sore arm; tired; itching; This is a spontaneous report from a contactable Nurse(Patient). A 79-years... Read more
Sore arm; tired; itching; This is a spontaneous report from a contactable Nurse(Patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), dose 1st via an unspecified route of administration on 22Jan2021 as single dose for covid-19 immunisation. Medical history included High cholesterol (Verbatim: High cholesterol). Concomitant medications included rosuvastatin, acetylsalicylic acid (ASPIRIN (E.C.)), zinc, alendronate sodium (FOSAMAX), Multivitamins. Patient had first Pfizer vaccine and the only thing had sore arm and got really tired and the sore arm went away, it descended in about 12 hours and gracely went away, after that it started itching. Patient think she started having difficulty was the morning of 13Feb2021. Patient was not experiencing side effect anymore. Patient did not took any treatment. The outcome of the event was recovered.
79 2021-04-20 pain in extremity Developed significant bruising within minutes/hours and has had significant limb pain for 11 days. A... Read more
Developed significant bruising within minutes/hours and has had significant limb pain for 11 days. Also radiating down arm and up into chest and back
79 2021-04-21 numbness, pain in extremity, cold extremities Patient with a history of LLE revascularization on 2/1/2021 with fem-bkpop 6mm PTFE bypass for limb ... Read more
Patient with a history of LLE revascularization on 2/1/2021 with fem-bkpop 6mm PTFE bypass for limb salvage in the setting of rest pain and great toe gangrene. She was discharged on Xarelto. Patient was admitted to the hospital on 4/13/2021. Patient reported she noticed return of the rest pain to the left lower extremity starting on 4/12/2021. Patient was found to have acute on chronic limb ischemia of the LLE and was found to have an occluded left femoropopliteal bypass graft. She was taken to the OR on 4/14/2021 and underwent a thrombectomy and removal of distal portion of the graft, which appeared to be infected. Cultures from the left femoral thrombus was positive for gram-negative rods. Blood cultures from 4/13/2021 were positive for Pseudomonas aeruginosa. Postoperatively, her left lower extremity continue to be numb, cool, and she was unable to dorsiflex the foot. Patient ultimately underwent a left lower extremity below the knee amputation on 4/16/2021. Patient remains hospitalized at this time.
79 2021-04-21 pain in extremity Severe back and leg pain lasting at least 6 weeks; still continuing, but now about 60% better than i... Read more
Severe back and leg pain lasting at least 6 weeks; still continuing, but now about 60% better than it was. Must use a walker due to pain Saw neurologist's Nurse Practioner and am receiving Physical Therapy 2x weekly. Scheduled to see doctor at pain clinic about injection in low back.
79 2021-04-23 numbness left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ank... Read more
left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; little bit of soreness on my left arm where the injection went; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (Batch/Lot Number: EL9269) as SINGLE DOSE for covid-19 immunization. Medical history included blood cholesterol, glucose tolerance impaired, pre-diabetic with HbA1C 6.1. Patient was allergic to Penicillin (swell), Metformin (swell), Sulfa (breathing trouble) and Allegra (headache). Concomitant medication(s) included rosuvastatin, calcium, vitamin D3, vitamin B complex. On 09Feb2021 (Monday, same day of vaccination, patient experienced little bit of soreness on my left arm where the injection went, on 10Feb2021 (Wednesday) left leg went to sleep and when stood up i fell on my left foot; maybe i have just sprained my ankle and there was extreme, swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing (Throbbing pain). The patient was treated with Ibuprofen 200 mg (Intent: Advil) and Aspirin but it was not doing anything to the patient. Patient states that she was usually very healthy and dont have problem with blood pressure. She was prediabetic and just taking care with diet and exercise. Patient was worried if this affect heart in anyway. There was a heart disease on her mother's side of the family, everybody on her side of the family died of a heart attack and patient younger brother has a stent put in and seen other people who have heart problems, and they have the swollen legs and feet and just wondering if that's the same thing that's happening to her. The second dose of vaccine was scheduled for 03Mar2021. The outcome of the events was unknown.
79 2021-04-24 feeling hot, breast pain, cold sweat, pain in extremity I went to the hospital with palpitations; lightheadedness; She had terrible back pain in center of b... Read more
I went to the hospital with palpitations; lightheadedness; She had terrible back pain in center of back; She felt achy; fatigued; back discomfort; she had a lot of shoulder, under arm, and left breast swelling; she had a lot of shoulder, under arm, and left breast swelling; she had a lot of shoulder, under arm, and left breast swelling; Her breast felt like it weighed 60 pounds and ached.; had the worse headache; Her shoulder blade was tender; neck pain; achy feeling was ongoing with her muscles; achy feeling was ongoing with her legs; legs felt rubbery; short winded; sweaty; she felt clammy and hot.; she felt clammy and hot.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration in left shoulder on 11Feb2021 at age of 79-year-old at single dose for COVID-19 immunization; methylprednisolone (MEDROL, Tablet), orally from 20Feb2021 to 26Feb2021, at 4 mg, by mouth, frequency was different based on the day, from 27Feb2021 to an unspecified date, at unspecified dose for swelling, the back. Medical history included thyroid and pericarditis fluid. Family history included brother had heart disease. There was no prior vaccinations within 4 weeks. Concomitant medication included levothyroxine sodium (SYNTHROID) ongoing for thyroid for 20 years. Historical vaccine included first dose of bnt162b2 in left shoulder on 21Jan2021 (Batch/lot number: EN6201) for COVID-19 immunization with no side effects. The patient had her 2nd Pfizer vaccine dose on 11Feb2021 and received a "medrol pack" on 20Feb2021 for "shoulder, back and neck pain. She have felt lousy for 4 weeks. She went to the hospital with palpitations and it probably was from the 2nd pack of methylprednisolone, she was prescribed after the 1st pack did not really help her pain. She haven't been sick or had a cold for 25 years and the 2nd dose through her for a loop. She stated her daughter called her and she said that her doctor told her that her vaccine may not be effective and she may not be protected because she took methylprednisolone. The patient received the second vaccine on 11Feb2021 and she had a lot of shoulder, under arm, and left breast swelling. The patient mentioned she went to her doctor because after calling the COVID hotline they said they had cases where some of the vaccine had seeped into the lymph nodes. She was told to have her lymph nodes. No patient demographic details provided regarding those other patients who had the vaccine seep into lymph nodes. She went on to explain she went to the doctor, but the doctor said there were no problems with the lymph nodes. On 13Feb2021, she felt achy and fatigued, back discomfort. The lightheadedness occurred on 18Feb2021. The doctor gave her a high dose of the methylprednisolone 4mg pack for a week. 16 days later on 27Feb2021 it had not touched the discomfort in back, fatigue and lightheadedness and gave her another pack of methylprednisolone. She also had heart palpitation, was sweaty and went to the Emergency Room. The patient mentioned she took a low dose of levothyroxine sodium (SYNTHROID). She asked the doctor about the methylprednisolone being taken after the shot. The patient heard it diminished the effect of the shot, that she may not have as much protection. She had called the COVID hotline to address this issue and they said people who were on chronic steroid therapy had no problem as far as they know. The patient asked if she was protected because she had the methylprednisolone pack the first one within 9 days after shot and a second pack 16 days later. She took a low dose of generic levothyroxine sodium every day. She commented she was concerned with the drug interaction and wanted to make sure still protected. She was informed by individual who answered COVID hotline she felt like she was still protected because others have been on chronic steroid therapy. Shoulder swelling started a couple day after the second shot, explained it was there or about around 13Feb2021. Her shoulder blade was puffy and tender. The swelling went into the arm and breast. Her breast felt like it weighed 60 pounds and ached. That took a while to go away. The patient explained initially it was also there or about around 13Feb2021 when she noticed she was so fatigue and had the worse headache (Feb2021), she never got nauseous. Her shoulder was still swollen a week ago as of 09Apr2021. She went to a chiropractor for an adjustment and the chiropractor said shoulder was still a little swollen. She had terrible back pain in center of back on 18Feb2021. It was so much that she was afraid something else was going on. The patient stated the swelling it was ongoing up until a few days ago as of 09Apr2021. She still had puffiness around that area when went to chiropractor. For the back discomfort she went to chiropractor for adjustment. She was unsure when that discomfort went away. The achy feeling was ongoing with her muscles and legs until last week as of 09Apr2021 when she started to feel better. Her legs felt rubbery. Her muscles felt achy. She felt better as of 09Apr2021. It had gotten better within the last week as of 09Apr2021. The fatigue was ongoing until last week as of 09Apr2021. The patient felt so bad for month and had no idea what was going on. Her lightheadedness went away last week as of 09Apr2021. She commented she did not want to blame all of this on the shot because she did not know what methylprednisolone did to her. The patient confirmed she had back discomfort. She still had some back discomfort. She started to fell short winded a week before the heart palpitations appeared really bad on 21Mar2021. She did not feel short winded anymore, but she was unsure when that stopped. With her heart palpitation she felt clammy and hot. Therefore, she wen to the ER. The heart palpitations gradually got better, and probably stopped totally last week as of 09Apr2021. She mentioned she had a headache for a good month after the second shot. It started either the 13Feb2021 or 14Feb2021. She stated all her symptoms were getting much better since last week as of 09Apr2021. There was no other treatment beside the methylprednisolone for her symptoms. Therapy start and stop date of methylprednisolone captured as confirmed by reporter in formal field, unable to clarify further. The patient confirmed all had been discarded and no lot/exp/NDC to provide. When she was in Emergency room, they did two EKG, drew blood work for the heart, chest x-ray back and front, and verified vital signs which were all good. She went home that same night on 21Mar2021. She went back to doctor on 05Apr2021 and did another chest x-ray and another echocardiogram and everything was fine. The event heart palpitation required a visit to emergency room, the patient was not sure if from the vaccine or methylprednisolone. The patient's heart rate got to 120, her normal was 80. The relevant Tests on 21Mar2021 they did Chest x-ray back and front, a couple EKG and blood work. The patient went back about a week ago as of 09Apr2021 because she was still not feeling great. They did an EKG, ordered echocardiogram and chest x-ray which were done on 05Apr2021. Test results came back on 08Apr2021. She had pericarditis fluid in the past and that's what they were checking for with the echocardiogram. The lab tests and procedures for investigation on 21Mar2021 included: chest X-ray: negative, EKG: negative, blood work: negative, negative. The action taken in response to the events for the methylprednisolone was unknown. The outcome of achy, back discomfort, back pain was resolving, the outcome of short winded was resolved in 2021, outcome of headache was resolved in Apr2021, the outcome of other events was unknown. Information on the batch number has been requested.
79 2021-04-24 tremor Pneumonia; got Covid; doesn't have her appetite back; still kind of shaky/was trembling and shaking;... Read more
Pneumonia; got Covid; doesn't have her appetite back; still kind of shaky/was trembling and shaking; lives with her niece and she found her in between china cabinet and fireplace and asked her how long she been there and she didn't know/going to the bathroom on herself and she doesn't recall that; This is a spontaneous report from a contactable consumer (reported for herself). This 79-year-old female patient received her first dose of the BNT162B2 (Pfizer covid vaccine, Lot number: ER2613 expiry date: unknown) via an unspecified route at left arm as a single dose on 23Mar2021 11:00, for Covid-19 immunization. Medical history included diabetic, cholesterol, acid reflux; had a reaction to tetramycin: she had shortness of breath, sweating, and light headed-ness, 30 years prior to this report. She stated that it was a form of penicillin and they didn't have penicillin so they gave her something else. Concomitant medications included metformin(METFORMIN) for diabetic, fexofenadine hydrochloride (ALLEGRA) and ibandronate sodium (BONIVA). It was reported that she skipped Boniva, that she usually would take at the end of the month. On 25Mar2021, two days after first dose, she got covid and pneumonia . She visited emergency room and was admitted in the hospital from 26Mar2021 till 05Apr2021. The patient did not have her appetite back, felt still kind of shaky, and was trembling and shaking. She did not remember what happened on the 24Mar2021 and 25Mar2021. It was stated that she was improving but she was not back to par. she was not trembling. She stated that she was not fully recovered. She was scheduled for her second dose in 2 weeks on 13Apr2021. It was stated that she had got a list of concomitant medications she was taking (unspecified names) and she did not think any of them would have interacted with this and she was taking them way before she got the Covid shot, also stated that she did not think she had bad underlying issues. The patient had her blood sugar checked and was given her insulin because of Covid and something else. She did not receive any additional vaccines on same date of the Pfizer Suspect or prior vaccinations (within 4 weeks). The patient did not have any Antipyretic (around the date(s) of Vaccination). The patient was recovering from the event of Pneumonia. The outcome of the events of doesn't have her appetite back and shaky/was trembling and shaking was not recovered, however the outcome of the events of Covid and did not remember what happened on the 24Mar2021 and 25Mar2021 was unknown. No further information was provided.
79 2021-04-26 weakness Patient was fully vaccinated. Presented to ED on 4/24/2021 with fever of 101.8, chills, weakness, m... Read more
Patient was fully vaccinated. Presented to ED on 4/24/2021 with fever of 101.8, chills, weakness, malaise/fatigue. Pt tested and COVID-19 PCR positive. Patient remains hospitalized
79 2021-04-26 discomfort 1st day: sleepy; 2nd day: some achiness at injection sight; 2nd day: some achiness at injection sigh... Read more
1st day: sleepy; 2nd day: some achiness at injection sight; 2nd day: some achiness at injection sight and body; 3rd day: occasional light diarrhea; discomfort; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A 79-year-old female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200, Expiration date: Not reported) via an unspecified route of administration in the left arm on 18Feb2021 09:45 as SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (OMEPRAZOLE) and paracetamol (TYLENOL 8 HOUR). The patient experienced on 18Feb2021 13:00; 1st day: sleepy, 2nd day: some achiness at injection sight and body, 3rd day: occasional light diarrhea, discomfort. The patient was not tested for COVID-19 prior to vaccination and after vaccination. The patient has not received any other vaccine within four weeks. The patient was treated with Tylenol and Pepto-Bismol. The outcome of the events was recovering.
79 2021-04-27 numbness excruciating cramps in stomach; numbness in hands; numbness in arms; This is a spontaneous report fr... Read more
excruciating cramps in stomach; numbness in hands; numbness in arms; This is a spontaneous report from a contactable consumer (patient, self-reported). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Right arm on 06Feb2021 as SINGLE DOSE for COVID-19 immunization. Medical history included diabetes mellitus from 2000 and ongoing Verbatim: Diabetes. Concomitant medications included metformin taken for diabetes mellitus from 2000 and ongoing insulin glargine (LANTUS) taken for diabetes mellitus from 2011 and ongoing. On Feb2021 the patient experienced numbness in hands, numbness in arms and on 24Feb2021 when she was in the kitchen she had excruciating cramps in her stomach. The patient would receive the second dose this Saturday. The clinical outcome of the events was not recovered except excruciating cramps in stomach was recovered on 24Feb2021.
79 2021-04-30 pain in extremity Had been recovering from broken right arm she had fallen on ice. The broken arm was pretty severe; H... Read more
Had been recovering from broken right arm she had fallen on ice. The broken arm was pretty severe; Had been recovering from broken right arm she had fallen on ice. The broken arm was pretty severe; sore left arm; This is a spontaneous report from a contactable consumer (patient's husband). A 79-years-old female patient received first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 79-years-old, via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Lot Number: EP6955) as single dose for covid-19 immunisation. The patient medical history was none. The patient's concomitant medications were not reported. No Additional vaccines administered on same date. No Prior vaccinations within 4 weeks. Repoeter stating that he and his wife had shot number one, 27Mar2021 and are scheduled for second shot 20Apr2021. Wife had no symptoms, maybe a bit of a sore arm on 27Mar2021. Sore left arm, same arm as shot. Arm was sore for the day. Treatment was none. Had been recovering from broken right arm she had fallen on ice. The broken arm was pretty severe. Was prescribed pain medicine for a week but did not take because it makes her feel funny. Is one of those powerful medications, can't remember the name. No AEs require a visit to Emergency Room or Physician's office. Event outcome of sore arm was recovered on 27Mar2021, of broken right arm was recovering, of the remaining was unknown. No follow-up attempts are needed. No further information is expected.
79 2021-04-30 pain in extremity Very sore arm from site to hand over 6 weeks Doc can?t figure how to treat
79 2021-04-30 tingling, pain in extremity, nerve injury sore arm; more of a tingle/tingling arm; like a nerve, maybe she hit a nerve; injection site pain; i... Read more
sore arm; more of a tingle/tingling arm; like a nerve, maybe she hit a nerve; injection site pain; injection site swelling; injection site redness; This is a spontaneous report from a contactable consumer (husband). A 79-year-old female patient (unknown pregnant at time of vaccination) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Mar2021 in the arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. On unspecified date, patient still had a sore arm, she just wanted to shake it, more of a tingle, like a nerve, maybe she hit a nerve. Patient saw her PCP doctor last week (Apr2021) and she was told that it sometimes happened. Patient experienced tingling arm 1 month after 2nd injection. She also experienced injection site pain, injection site swelling or redness on unspecified date. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
79 2021-04-30 tremor, discomfort exhausted/tiredness; She says she feels a little fuzzy, like she is not thinking clearly; Discomfort... Read more
exhausted/tiredness; She says she feels a little fuzzy, like she is not thinking clearly; Discomfort; mild malaise; Trembling; This is a spontaneous report from a contactable consumer (Patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6202; Expiry Date: 30Jun2021), administered in left arm on 03Mar2021 (at the age of 79-years) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced discomfort, mild malaise, trembling, on an unspecified date she says she feels a little fuzzy, like she was not thinking clearly and she says she was not able to do anything due to exhaustion. she has been having three days of discomfort and mild malaise for a week. The patient says she was not able to do anything due to exhaustion, so she thought Pfizer would want to know. She says that she could not type due to trembling to complete a report online. Patient second dose was on 26Mar2021, and they did not ask for her vaccine card, so she does not have and was not able to provide NDC/LOT/EXP from the second dose. She says that the NDC was not provided on her vaccine card for the first dose. The patient mentions a COVID test, but says that this was just a paper, she had forgot that she had a card, the test was to do a job. Patient says it was the second dose that she had a reaction after. She says she got both doses in her left arm. She says her reaction was discomfort and mild malaise beginning Saturday. Patient said that it has not got better or worse, she was having intermittent trembling periods where she would feel ok but then start shaking and be exhausted again, so it has been about the same since Saturday. Patient said that she will be ok for a couple hours, and then it will all start again, and she will shake all over. Patient felt a little fuzzy, like she was not thinking clearly, and so tired and trembling. The patient said that her prolonged reaction was not enough to go to the hospital, but she was not feeling so good, and thinks maybe people should be warned. The patient did not receive any treatment for adverse event. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
79 2021-05-01 muscle spasms, numbness, weakness Experiencing progressive weakness and numbness in arms and hands. Legs feel heavy. Hands become sti... Read more
Experiencing progressive weakness and numbness in arms and hands. Legs feel heavy. Hands become stiff and freeze in position, occasionally cramping. I've described the arm and leg sensations as "dead arm" and Heavy legs. Also have a feeling in them that I can't describe. I started paying attention to this in early March. Now it is frequentÂ…several times a day lasting for 15 to 20 minutes.
79 2021-05-02 inability to speak past medical history significant for coronary artery disease s/p PCI, chronic hypoxic respiratory fa... Read more
past medical history significant for coronary artery disease s/p PCI, chronic hypoxic respiratory failure on 2L, hypertension, multinodular goiter who presents to ED on 4/25/2021 with symptoms of progressive shortness of breath, dysphagia and neck pain. Labs showed elevated BNP of 3000 and a hemoglobin of 8.5. Patient was incidentally positive for COVID-19 pneumonia
79 2021-05-02 bell's palsy, facial paralysis On the 3 rd day after pt received her first shot. She started getting symptoms of Bells Palsy on the... Read more
On the 3 rd day after pt received her first shot. She started getting symptoms of Bells Palsy on the Right side of her face. Eye and mouth drooping. On 4/25/2021 she still has some drooping and her Right hand eye is blurry.
79 2021-05-03 inability to speak Aphasia CVA (cerebral vascular accident)
79 2021-05-04 pain in extremity Her arm was sore; hangover; sneezing; nose was stuffy; This is a spontaneous report from a contactab... Read more
Her arm was sore; hangover; sneezing; nose was stuffy; This is a spontaneous report from a contactable consumer (patient). A 79-Year- old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9265), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications were not reported. On 30Jan2021, patient nose was stuffy and she was sneezing. On 03Feb2021, patient experienced hangover. She has recovered completely she says the next morning she woke up and felt rejuvenated. She said the stuffiness and sneezing happened before the hangover feeling it was probably Saturday after the vaccine that she had the stuffy nose and sneezing, she says 30Jan2021 sounds right. She says she has recovered completely since then everything is going good. Patient asked who she was talking to she got the number off the paper she got after the Pfizer COVID 19 vaccine. She wanted to people applaud her people for being so orderly and efficient it only took, she only had to wait half an hour all together it was about 45 minutes but the efficiency was great that they gave them at the Hospital. She said she wanted to tell Pfizer how much she appreciated and just check to see how long after the vaccine could she have any kind of reaction. She said she was asking because she thinks she may have had a reaction but she does not know so she wanted to try to see if it was one. She said this happened a week later didn't have any thing when she got the vaccine except her arm was sore but that was it. Then, she is 80 years old and she doesn't drink but she felt like a she had a hangover and her nose was stuffy and she sneezing. Patient declined to provide email address. She hardly ever uses it. It was reported that decline to provide because she was fine. She feels like a million bucks. She had to get her glasses to read the vaccine record card. She does not see and expiration date or NDC number just the date she got it. It was reported that she did not want to get the dangerous flu at her age that would be a horrible death. She was only on high blood pressure medication. The outcome of the event her arm was sore was unknown and outcome of the other events was recovered. No further information provided.
79 2021-05-08 flushing, tingling SEE LIST FOR LIGHT HEADED , FACE FLUSHED 5/6 DAY OF 5/9 AWOKE 00:45 WITH SHORTNESS OF BREATH, FA... Read more
SEE LIST FOR LIGHT HEADED , FACE FLUSHED 5/6 DAY OF 5/9 AWOKE 00:45 WITH SHORTNESS OF BREATH, FACE PRICKLY feeling , CHILLS, oxigen sat 99/% lung clear,
79 2021-05-08 migraine Migraine, sleepy, loss taste (still no taste as of today), bruises on arm.
79 2021-05-09 numbness, feeling of insects crawling on skin, tingling Patient has been complaining of left hand paresthesias since receiving her COVID-19 vaccination. Sh... Read more
Patient has been complaining of left hand paresthesias since receiving her COVID-19 vaccination. She received her first dose in her left upper extremity on 3/12/2021. Paresthesias began 4/8/2021. She had her second vaccination on 4/11/2021 in her right arm and reports one episode of right paresthesia on 5/5/2021. Describes paresthesias as numbness and tingling and have been constant since onset in left hand. She at times will even have a sensation of bugs crawling across her body.
79 2021-05-10 pain in extremity vary sore arm; pain in part of the neck; bad headache; Injection site swelling; Injection site redne... Read more
vary sore arm; pain in part of the neck; bad headache; Injection site swelling; Injection site redness; Nervousness; Feeling unwell; Arm pain; Vomiting; Her neck hurts; Her hurting shoulder; This is a spontaneous report from contactable consumer. A 79-years old contactable female consumer (patient) reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EW2171), via an unspecified route of administration on 27Apr2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on 27Mar2021 for covid-19 immunization (first dose and lot number- ER8732). On an unknown date, the patient experienced very sore arm, pain in part of the neck, bad headache, injection site swelling, injection site redness, nervousness, feeling unwell, arm pain and vomiting. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
79 2021-05-10 pain in extremity her arm was sore near the injection site; then the soreness spread to her shoulder; she can barely m... Read more
her arm was sore near the injection site; then the soreness spread to her shoulder; she can barely move her arm and shoulder; She added she is in "excruciating pain";; it is "terrible" and "debilitating".; her arm pain; This is a spontaneous report from a contactable consumer (reporting for herself). A 79-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunisation. Patient medical history included spinal stenosis from an unknown date and unknown if ongoing. Patient concomitant medications were not reported. Patient persistently asked what to do to manage her symptoms from the Pfizer-BioNTech COVID-19 vaccine. She explained her doctor said he cannot help and has not seen this before. She then threatened to call her lawyer if a doctor or scientist from the company could not assist her. It was stated that patient received the second dose of the Pfizer-BioNTech COVID-19 vaccine on 26Feb2021. She explained a few days after, her arm was sore near the injection site, then the soreness spread to her shoulder and she can barely move her arm and shoulder. She added she was in excruciating pain; it is terrible and debilitating. She took pain medicine for the arthritis in back and described it as spinal stenosis. She mentioned this medication was barely doing something to help with her arm pain. She then specified she also consulted her doctor who prescribed gabapentin and methyl prednisone tablets, which aren't relieving her arm pain. She expressed her concerns on the persistence and intensity of her pain. She asked if her symptoms were reported as side effects to the vaccine. Patient expressed her disappointment on the lack of information provided to manage her symptoms from the Pfizer-BioNTech COVID-19 vaccine. She said she was excited to get this vaccine among the other brand, and now that she is injured from it, she feels like Pfizer should be by her side and thus claims to have help from Pfizer. Outcome of the event her arm pain and her arm were sore near the injection site was not recovered. Outcome of the other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained
79 2021-05-12 flushing Hypertension; Tachycardia; Extreme flushing to face and neck; glowing red; took her pulse and it was... Read more
Hypertension; Tachycardia; Extreme flushing to face and neck; glowing red; took her pulse and it was 145; Persistent head to toe macular erythematous Rash; Dull Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered on the left arm on 21Apr2021 13:12 (Batch/Lot number was not reported; Expiration Date: 31Jul2021) as 1st dose, single for covid-19 immunisation. Medical history included fibromyalgia (diagnosed more than 20 years ago), bladder cancer (diagnosed 13 years ago the first time, 8 reoccurrences and has been cancer free for 2 years, cancer free for 2 years), multi drug allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities, diabetes, and obesity. Concomitant medications included lisinopril, levothyroxine, and oxazepam. No vaccines received within 2 weeks. In 12 minutes after the injection on 21Apr2021, while she was still sitting in the parking lot, patient developed tachycardia on and extreme flushing to face and neck on 13:20. They were as red as being in the sun. She was aware of tachycardia first. Then she looked in the mirror and was glowing red. Patient was observing in parking lot and took her pulse and it was 145. Persistent head to toe macular erythematous rash occurred next. They took her to the ER about 20 minutes after the injection. In the ER, she was given 25mg of Benadryl IV and 125 mg of Solumedrol IV. When both of those wore off the next day, the generalized rash came back on Thursday (22Apr2021). The rash was persistent but not as flushed looking as before. When they got her into ER, the first blood pressure reading was 198/117, which was within 20 minutes of injection. Hypertension was experienced on 13:30. Her blood pressure usually was fairly low and was back to normal now. She had one reading of 124/76 to 170/something. Her normal range is anywhere between 150-170/70-80's. She is on Lisinopril. The other morning when it was 124/76, was just a fluke. That was an unusually good reading. They did a regular panel of lab work when she went to the ER. They did not tell her that anything was abnormal. She asked them to run an A1C, but they told her they could not. They did a chest film, EKG, placed IV to give medications, but no fluids given. Her doctor said not to get second dose of the vaccine. She had it at the hospital and they had reports of other people with a rash. The patient considered the events tachycardia, extreme flushing, macular erythematous rash and hypertension were medically significant while for headache was non-serious.; Sender's Comments: The reported events were possibly causally related to the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
79 2021-05-13 tremor Arrival Date: 2/14/2021 Discharge Date: 2/18/2021 Primary Discharge Diagnosis: Principal Problem: ... Read more
Arrival Date: 2/14/2021 Discharge Date: 2/18/2021 Primary Discharge Diagnosis: Principal Problem: Sepsis (HCC) POA: Yes Active Problems: GERD (gastroesophageal reflux disease) POA: Yes Portal hypertension (HCC) POA: Yes Thrombocytopenia (HCC) POA: Yes Esophageal varices (HCC) POA: Yes Chronic systolic heart failure (HCC) POA: Yes Essential hypertension POA: Yes Hyperlipidemia POA: Yes Operations/Procedures: None Pertinent Diagnostic Studies: Xr Chest 1 View-portable Result Date: 2/15/2021 Portable chest at 0039 hours HISTORY: New left internal jugular catheter. AP sitting portable chest compared to February 14, 2021 and shows introduction of a left internal jugular catheter with the tip doubled back on itself possibly in the distal brachiocephalic vein. No evidence of pneumothorax. There is a coarse appearance to the pulmonary interstitium bilaterally some of which may reflect chronic disease though the possibility of a very small infiltrate at the left base retrocardiac cannot be excluded and has not changed. No significant pleural effusion or definite acute vascular congestion. The heart, mediastinal and hilar structures are not enlarged or changed. Degenerative disease of the spine is noted with a mid thoracic scoliosis convexity to the right. Left internal jugular catheter in place with distal tip curved back on itself possibly in the distal brachiocephalic vein. Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Xr Chest 1 View-portable Result Date: 2/14/2021 PROCEDURE: XR CHEST 1 VIEW-PORTABLE HISTORY: cough COMPARISON: 9/27/2020 Impression: Limited portable view obtained. Heart mediastinum stable There is mild central vascular and interstitial prominence which could reflect developing mild interstitial edema or interstitial pneumonitis. No severe CHF. Some slightly more focal patchy increased interstitial airspace opacity in the left lower lobe retrocardiac region is identified and could represent a developing infectious inflammatory infiltrate. Clinical correlation and follow-up advised Incidental findings: CXR- Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Test Results Pending at Discharge: Pending Labs Order Current Status Microscopic Urinalysis In process Blood Culture Peripheral Preliminary result Blood Culture Peripheral Preliminary result Active Issues Requiring Follow-up: ISSUE- Needs to follow up with PCP Discharge Medications: Discharge Medications New Medications Sig cefpodoxime 200 MG tablet Commonly known as: VANTIN Start taking on: February 19, 2021 Take 1 tablet (200 mg total) by mouth daily. Do not start before February 19, 2021. Quantity: 6 tablet Discharge Disposition: Home Or Self Care Code Status: DNR Details of Hospital Stay History of Present Illness (from the H&P) CHIEF COMPLAINT: Chills fever, nausea, vomiting, diarrhea after receiving Covid vaccine #2 (Pfizer) HPI: This is a 79 y.o. female with a past medical and surgical history as below-most significant for breast cancer that was diagnosed in 2017, portal hypertension secondary to fatty liver in 2019, resultant esophageal varices that bleed presents with the following chronological history: Approximately 9 AM yesterday morning she went to the clinic for her second Covid vaccination. At that time her temperature was 97.3. She felt fine the rest the day. At 1 AM she woke up with shakes. She continued with nausea and that resulted in vomiting and then diarrhea. She also had severe pain in her thighs. This was severe enough that she called the ambulance. Patient also relates later that she had had some burning on urination 2 days prior to the vaccination. She had leftover Macrodantin that she took 9 PM yesterday. Also relates back in December she was seen by Dr for vaginal infection and 2 times a week she has to administer intravaginal antibiotics. She has had multiple GI bleeds secondary to esophageal varices and is followed regularly by Dr who has had to do multiple banding procedures on her. She also relates she has an enlarged spleen and is followed by Dr. In the emergency room she was noted to be febrile and hypotensive. She received a total of 5 L of normal saline in the ER to bring her pressures up with a systolic below 100. She has a very elevated procalcitonin as well as lactic acid. Urine is positive for large amount of blood and small leukocyte esterase Hospital Course 79 y.o. year old female with HTN, infiltrating ductal carcinoma of the right breast stage I status post lumpectomy with positive margins was on anastrozole but taken off secondary to abnormal liver enzyme testing, CLL/thrombocytopenia stage I with no treatment needed, fatty liver complicated by portal hypertension/splenomegaly resulting in bleeding esophageal varices, history of viral cardiomyopathy in 2006, B12 deficiency, history of admission for septic shock, chronic diarhea, presented to the emergency room on 2/14 complaining of fevers, myalgias fatigue nausea and vomiting 24 hours after having a second dose of COVID-19 vaccine. She was admitted for septic work-up and later found to be hypotensive after 7L of fluids and was transferred to the ICU for septic shock, left IJ was placed. Source of infection found to be septic from UTI. Urine culture sterile with less than 1000 colony forming units and blood cultures no growth to date. On the day of discharge. Shock resolved. Her procalcitonin trended down. Wonder whether she had an exaggerated response to the Covid vaccine given that today the urine culture shows no growth. Regarding acute on chronic diarrhea she had unremarkable GI PCR and diarrhea improved after starting Imodium. She is had extensive work-up for this with GI as outpatient and days colonoscopy planned in the near future. CLL with splenomegaly/nodular hyperplasia of the liver with noncirrhotic portal hypertension/neutropenia/thrombocytopenia/hyperbilirubinemia/esophageal varices requiring banding in the past -Was restarted on propanolol and midodrine prior to discharge. -Chronic stable anemia/B12 deficiency-getting supplementation every 3 months Thrombocytopenia -she did have drop in platelet counts during admission while being on pantoprazole and Lovenox and these were discontinued and platelet count stabilized. She can have repeat CBC as outpatient to document improvement in platelet count. She was not noted to have any platelet type bleeding. History of right-sided breast cancer status post lumpectomy was on anastrozole but stopped secondary to liver disease Lab Studies: Lab Results Component Value Date GLUC 86 02/18/2021 CALCIUM 8.4 (L) 02/18/2021 NA 149 (H) 02/18/2021 K 3.8 02/18/2021 CO2 23 02/18/2021 CL 114 (H) 02/18/2021 BUN 18 02/18/2021 CREAT 0.9 02/18/2021 Results from last 7 days Lab Units 02/16/21 0702 MAGNESIUM mg/dL 1.9 Lab Results Component Value Date CALCIUM 8.4 (L) 02/18/2021 PHOS 2.4 (L) 02/17/2021 Results from last 7 days Lab Units 02/18/21 0724 02/14/21 1855 WHITE BLOOD CELL COUNT Thou/uL 4.1 < > 2.9* HEMOGLOBIN g/dL 10.0* < > 8.8* HEMATOCRIT % 30.0* < > 27.7* PLATELET COUNT Thou/uL 33* < > 37* NEUTROS PCT % -- -- 84.7 NEUTROS ABS Thou/uL -- -- 2.40 LYMPHS PCT % -- -- 10.9 LYMPHS ABS Thou/uL -- -- 0.30* MONOS PCT % -- -- 3.1 MONOS ABS Thou/uL -- -- 0.10* EOS PCT % -- -- 0.8 EOS ABS Thou/uL -- -- 0.00 BASOS PCT % -- -- 0.5 BASOS ABS Thou/uL -- -- 0.00 < > = values in this interval not displayed. Lab Results Component Value Date ALT 28 02/18/2021 AST 15 02/18/2021 GGT 22 09/09/2019 ALKPHOS 116 02/18/2021 BILITOT 1.0 02/18/2021 Physical Exam at Discharge Last Vitals: BP 117/70 (BP Location: Left arm, Patient Position: Lying) | Pulse 73 | Temp 98.1 °F (36.7 °C) (Tympanic) | Resp 18 | Ht 1.626 m (5' 4") | Wt 73.2 kg (161 lb 6 oz) | SpO2 94% | BMI 27.70 kg/m² Patient was seen and examined by me on the date of discharge. General Appearance: Alert, Awake, not in acute distress. Cardiovascular: S1-S2 regular, no murmurs present. Respiratory: Bilateral air entry present, no added sounds heard Gastrointestinal: soft, non-tender, non-distended, bowel sounds present. Extremities: B/l LE edema I spoke with the patient regarding the discharge plan. The discharge plan was discussed with the case management and the nursing staff. Patient verbalzied understanding of the discharge and was agreeable for the discharge plan. Called pt;s husband to give update on care plan but got voice mail. Condition on Discharge: Improved
79 2021-05-18 weakness ED Discharged 4/4/2021 (2 hours) Hospital ED MD Last attending ? Treatment team Acute cystitis wit... Read more
ED Discharged 4/4/2021 (2 hours) Hospital ED MD Last attending ? Treatment team Acute cystitis without hematuria +1 more Clinical impression Sore Throat ? Fever ? Back Pain Chief complaint ED Provider Notes MD (Physician) ? ? Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with ? Sore Throat ? Fever ? Back Pain 80-year-old female with multiple complaints. Patient states she had her second Covid vaccine yesterday. Since then she is complaining of having generalized weakness, headache, body aches, back pain, cough, nausea, generalized weakness and dizziness. No abdominal pain. She has nausea but no vomiting or diarrhea. No dysuria. Denies any chest pain.
79 2021-05-18 feeling cold she has a lot of fatigue did not take temp but is colder than usual and wearing sweater which she sa... Read more
she has a lot of fatigue did not take temp but is colder than usual and wearing sweater which she says she normally doesn't, and if she takes a deep breath it is tight and hurts her chest and does have an occasional cough Contact with and (suspected) exposure to covid-19
79 2021-05-20 unresponsive to stimuli, feeling hot 10 minutes after the shot was given, her daughter yelled out to us that patient had slumped over mom... Read more
10 minutes after the shot was given, her daughter yelled out to us that patient had slumped over momentarily in the chair of the waiting area. We went out to assist her, she was sitting upright with assistance from her daughter when we got out there. As we asked her questions, she was staring blankly at us and not responding to our questions, we called 911. She did not answer us for as least a couple minutes, although there was a pulse and she was breathing. She was sweating profusely. Daughter said she was warm and dizzy right after, also that she has a history of fainting and fear of blood.
79 2021-05-24 feeling hot headache; fatigue; pain at the site; pain at the site, swelling; chills; lethargic; temperature and ... Read more
headache; fatigue; pain at the site; pain at the site, swelling; chills; lethargic; temperature and it was holding steady at 99 degrees; her arm had gotten red and became very hot; her arm had gotten red and became very hot; This is a spontaneous report from a contactable Nurse (Patient herself). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), on 28Jan2021 at 09:15 (Batch/Lot Number: EL1283) (at the age of 79-year-old) as first dose intramuscular administered in arm right unknown dose, single for covid-19 immunisation. Medical history included ongoing Gastric anomalies, ongoing Allergies, breast cancer (also took cancer medication for 5 years but hasn't had that in 2 years), she had 2 implants (ongoing), but she hasn't had any radiation or chemotherapy in the last 2 years. She has arthritis down her spine and a couple other things wrong with her. She states it magnified those conditions and it stayed that way for a while. Her historical vaccine reported Flu in Sep2020. Ongoing concomitant medication included patient states she does have allergies and she does take daily medication for it. She also has a nasal medication, Montelukast and she was also on an oral tablet every day also takes dexlansoprazole (DEXILANT) which was a very powerful antacid for her gastric anomalies. She wasn't supposed to take it but for only 3 months but she has continued to take it for 5-10 years, more like 10 years and no one has stopped her. She states "Patient had a headache, fatigue, pain at the site, swelling but no lymphadenopathy after receiving her first dose. She had cancer in the past but clear now. Patient mentioned she got the first dose on 28Jan2021 and scheduled for her second dose 23Feb2021. Caller wants to know the side effects expected with the second dose. Patient received the first COVID-19 vaccine on 28Jan2021 at 9:15am. Around 2am or 3am the following morning (29Jan2021), her arm had gotten red and became very hot. It became really quite swollen. She couldn't move without it hurting. She took Tylenol without any advice from a doctor, she just took it herself. The Tylenol relieved some of the pain, but not all of it. Patient verifies the Tylenol is not handy when probed for NDC/UPC, Lot number or expiration date. She also started to experience chills but she never took her temperature. So at this point all of this was within 2 days after two 24 hour periods. Patient states on the 3rd day, everything seemed to lighten up and started to back off a bit. She took her temperature on the 3rd day and it was holding steady at 99 degrees. She didn't feel that any of this was earth shattering. She was taking more Tylenol and it relieved some symptoms. The Tylenol did help. By the fourth day, she was almost normal. She was so lethargic. She became extremely lazy and was laying around the TV. She states its all COVID's fault. She continued to have the magnification of her pre-existing conditions. Patient mentions her weight may be a little more than provided. She has been eating ice cream. Patient confirms at this point, she has recovered to her normal self, eating ice cream watching TV and playing with the puppies. The caller confirms the symptoms started letting up and she has recovered. Patient states she had some ablations on her back and muscle spasms. Her muscle spasms are pretty mellow and she hasn't had any treatments in a year and a half. Outcome of the event pain at the site was recovering and all other events was unknown. Events, redness in arm, arm became very hot and swollen, Chills and Lethargic was reported as related. Follow-up attempts are completed. No further information is expected.
79 2021-05-25 pain in extremity tired; cold; head was in a fog; Staggering; Diarrhea; ears were ringing; arm was sore; body ache; ne... Read more
tired; cold; head was in a fog; Staggering; Diarrhea; ears were ringing; arm was sore; body ache; neck was painful; back of head pain; This is a spontaneous report from a contactable consumer (Patient). A 79-year old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140, Expiration Date Mar2021) into the left arm on 11Feb2021 at 4:00pm (at the age of 79-years-old) at single dose for COVID-19 immunization. Concomitant drugs included ciclosporin (RESTASIS) twice daily both eyes taken for dry eye; bimatoprost (LUMIGAN) one daily both eyes taken for glaucoma for 5-6 years, vitamin B complex 1 daily taken as supplement for 15-20 years; colecalciferol (D3) 2 daily during the winter and 1 daily in the summer taken as supplement for 3-4 years. She use to get a lot of sore throats. Her doctor suggested she take vitamins. Some that she took didn't help. On 11Feb2021 the patient experienced arm was sore not recovered, body ache recovered on 13Feb2021 and on 12Feb2021 she experienced tired recovered on 13Feb2021, cold recovered on 12Feb2021, head was in a fog not recovered, staggering recovered on 13Feb2021, ears were ringing recovered on 13Feb2021, Diarrhea recovered on 12Feb2021. Further reported the back of her head and neck was painful that was gone by 13Feb2021. Her arm was sore if she lays on it she can feel it. Unable to answer outcome of event for being tired,if she sits long enough she falls asleep. Her head still feels tender. She is no longer staggering. She feels comfortable going up and down stairs. The next dose is scheduled for 04Mar2021. She is considering not taking the second dose.
79 2021-05-28 weakness no strength at all in her legs and her arms, muscles didn't work at all; Nauseas; Temperature of 100... Read more
no strength at all in her legs and her arms, muscles didn't work at all; Nauseas; Temperature of 100.6 degrees; Headache; her joints swelled; her hands were swollen and tight; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), an unspecified route of administration, administered in Arm Right on 25Feb2021 at 10:30 (Batch/Lot Number: EL9267) as 1st dose, single for covid-19 immunization.Concomitant medication(s) included warfarin sodium (COUMADIN), she takes a 5mg tablet, by mouth, once daily on tuesday, thursday and saturday's. The rest of the days she takes a half of a 5mg tablet confirmed as a 2.5mg dose, by mouth once daily. Indication: She had 2 strokes about 12 years ago, so it keeps her blood regulated, not too thick or too thin, usually it's right on. When probed for any product information, the caller made the comment let her get in some light so she can see better. She confirms the bottle is dispensed in a pinky peach pharmacy vial. She sees an Rx number, Use by date: 26Jan2022 and losartan potassium (COZAAR) taken for blood pressure measurement was the generic for Cozaar, Losartan potassium. She takes a 25mg, tablet, by mouth, once daily for her blood pressure. She verifies this medication is also dispensed in a pharmacy bottle. She mentioned she takes both medications, Coumadin and the Losartan potassium, at night time because it's easier for her to remember. The patient stated she takes a blood pressure medication and a coumadin tablet, She clarifies she has been on these medications for a long time, more than the 2 week time period leading up to receiving the COVID-19 vaccine. She went to bed early on Friday night, 26Feb2021, because she had issues all day long and she forgot to take these medications. She only takes 2 pills at night but she forgot all about them because she had all that stuff going on during the day. o prior vaccinations within 4 weeks. Medical history included cerebrovascular accident (She had 2 strokes about 12 years ago). O 25Feb2021, the patient experienced headache and on 26Feb2021, the patient had asthenia, nausea , pyrexia (temperature was 100.6 degrees), joint swelling and peripheral swelling. It was reported that patient had a really crazy experience, She received her first dose on 25Feb2021 at around 10:30 am afterwards, she had just a regular headache and then the next morning, she tried to get out of bed and had no strength at all in her legs and her arms. She got up out of bed, and her legs would not hold her up so she collapsed on the floor. She mentions her husband is hard of hearing and she was calling for his name to help her. She could not even scoot on the floor, her muscles just did not work at all. The caller states her husband came in and got her up. She went to the bathroom and then for the rest of the day, she stayed in the recliner. Really, the next day, she got back her strength in her shoulders. She clarifies on Saturday, 27Feb2021, she started to get back her strength. She also read in the newspaper to not get a mammogram and a COVID-19 vaccine on the day and she did because they didn't know. She confirms her mammogram was scheduled on 25Feb2021 at 2pm, which was after when she received the COVID-19 vaccine, so her mammogram might not be right. The outcome of events recovered on 27Feb2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
79 2021-05-28 weakness sleepy and wanting to sleep all day; Chills; fever; weak; no appetite; fatigue; This is a spontaneou... Read more
sleepy and wanting to sleep all day; Chills; fever; weak; no appetite; fatigue; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267), via an unspecified route of administration, administered in right arm on 22Feb2021 12:00 (at the age of 79-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, acid reflux and shell fish allergy. The patient's concomitant medications were not reported. On 24Feb2021 at 12:00 chills, fever, no appetite, weak, fatigue, sleepy and wanting to sleep all day. The patient did not receive any treatment for the events. The patient did not have COVID prior vaccination. She was not COVID tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.
79 2021-05-28 numbness feeling the half of her face swollen, thick and numb; feeling the half of her face swollen, thick an... Read more
feeling the half of her face swollen, thick and numb; feeling the half of her face swollen, thick and numb; feeling the half of her face swollen, thick and numb; the tip of the tongue tingling and sore.; the tip of the tongue tingling and sore.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 27Jan2021 (age at vaccination 79-year-old) as 1st dose, single for covid-19 immunisation. Medical history included allergy related with sinusitis from an unknown date and its ongoing. Concomitant medication included prednisone (PREDNISONE) taken for sinusitis, start and stop date were not reported. The patient reported that she was administered with the first dose of the Pfizer's COVID-19 vaccine on 27Jan2021 (Wednesday) and a few hours after the administration of the vaccine she started feeling the half of her face swollen, thick and numb and the tip of the tongue tingling and sore. The patient reported that she took Prednisone that she had in her house and was previously indicated for the management of an allergy related with sinusitis. The patient reported that she has taken 3 doses of Prednisone, one each 24 hours. Patient asked for information about if her symptoms could be related with the administration of the Pfizer's COVID-19 vaccine. The outcome of the events was reported as unknown. Information on the Batch/Lot number has been requested Follow-up attempts are completed. No further information is expected.
79 2021-05-28 tremor, feeling cold a few little chills; I started shaking violently from chills; severe muscle pains all through my bac... Read more
a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever.; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick; taste problems; I thought maybe I had this COVID because I was sick; feeling a little chilly; This is a spontaneous report from a contactable other health care professional. A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6198) at the vaccination age of 79-year via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. Patient historical vaccine includes first dose of BNT162B2; LOT number: EL9269 ,which was administered on 12Feb2021 for COVID-19 immunization. Medical history included neuropathy peripheral and hypertension. Concomitant medications included, lisinopril taken for hypertension, gabapentin taken for neuropathy peripheral, levothyroxine and dicyclomine. On an unspecified date, the patient experienced I thought maybe I had this covid because I was sick; I had the taste problems and the doctor lately did a test on me to see if I still have the antibodies and I did not. so, he said no, it does not look like you had it; a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick and taste problems. On 05Mar2021 09:00 PM patient was feeling a little chilly. On an unspecified date the patient underwent lab tests and procedures which included blood thyroid stimulating hormone: unknown results, sars-cov-2 test: negative. The seriousness of all the event was reported as non-serious. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information expected.
79 2021-06-01 numbness 3/11 woke up with severe chills, joint pain and headache 3/25 experienced numbness down my entire le... Read more
3/11 woke up with severe chills, joint pain and headache 3/25 experienced numbness down my entire left side, had a severe headache and difficulty walking
79 2021-06-01 pain in extremity This is a spontaneous report from a contactable consumer. A 79-years-old female patient received BNT... Read more
This is a spontaneous report from a contactable consumer. A 79-years-old female patient received BNT162B2 (COVID-19 Vaccine, Solution for injection, Lot number: EM9809), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date, 10:00 (at the time of 79-years-old) as second dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The vaccination facility type was hospital. The patient previously took prolia for her bones and osteoporosis and historical vaccine as bnt162b2 (Lot Number: FF1283) on 25Jan2021 administered via unspecified route, in arm left as first dose for covid-19 immunisation. The patient had first COVID-19 shot this past Monday. Gets the next one in three weeks. The patient was told information by someone and wants to see if that information was correct. The patient would get Prolia shot on a Monday and that Wednesday would get the second COVID-19 Vaccine. The patient gets Prolia every six months for her bones and osteoporosis. The patient had sore upper arm- put ice on - gone melt day. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.
79 2021-06-01 tenderness, tremor She got her vaccine, she had no symptoms. The following day had very little soreness and nothing el... Read more
She got her vaccine, she had no symptoms. The following day had very little soreness and nothing else. Went to bed, woke up soaking wet, diarrhea, vomiting, dizzy. She did not have skin feeling funny like with regular flu, but mostly all intestinal. She changed her clothes and then was shivering and could not get warm, and had hard shaking chills. She slept very little and has had it continuous since the vaccine. She has been falling a sleep a lot, day, night and was previously very active and now falls asleep at a drop of a hat. Over the past week and a half has had the cold chills less, but has awakened moist. She is having the diarrhea and GI issues less, but feels nauseous at times during the day. She is still waking up between 11:00 and 2:00 waking up, but falls sleep a lot, does not have a regular schedule as she did before. It is not debilitating as much but still tired a lot.
79 2021-06-07 feeling cold I had pain on the left side of my head above the ear; I was freezing; had terrible chills; completel... Read more
I had pain on the left side of my head above the ear; I was freezing; had terrible chills; completely exhausted; My stomach hurt; couldn't eat; lost 2 1/2 lbs; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6198, Expiration Date: not reported) via an unspecified route of administration in left arm on 05Mar2021 at 13:30 (at the age of 79-year-old) as a single dose for COVID-19 immunization at pharmacy or Drug Store. Medical history included an unspecified allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included atenolol at a dose of 50 mg twice daily, received in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number PAA156051, Expiration Date: not reported), via an unspecified route of administration, in right arm on 10Feb2021 at a single dose for COVID-19 immunization and experienced very tired for over a day. On 05Mar2021 after the second shot at 18:30 (reported as within 6 hrs), the patient experienced pain on the left side of her head above the ear and was freezing, had terrible chills for 2-3 hrs and had to be covered with several blankets. Patient did warm up, but completely exhausted into Sunday AM (as per report), her stomach was hurt, couldn't eat and patient lost 2 1/2 lbs. Patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
79 2021-06-08 weakness I started feeling tired later on that afternoon and in the middle of the night I started having chil... Read more
I started feeling tired later on that afternoon and in the middle of the night I started having chills and fever. The very next day I was so weak I couldn't get out of bed and was having a hard time breathing. I called 911 and was taken to the hospital which resulted in being admitted.
79 2021-06-09 pain in extremity rectal bleeding; sensation/pain in her right arm; This is a spontaneous report from a contactable co... Read more
rectal bleeding; sensation/pain in her right arm; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW1051), dose 1 via an unspecified route of administration, administered in Arm on 15May2021 17:30 (at the age of 79years) as 1st dose, single for Covid-19 immunization. Medical history included allergic to lemons, vinegar and white wine, severe reaction to some eye drops 4-5 years ago, vomiting, and diarrhea, rectal bleeding, stomach hurt, and felt like her head was going to explode. The patient's concomitant medications were not reported. The patient reported that she was allergic to lemons, vinegar and white wine and can't take any pills because they make her stomach hurt, she now only takes natural medicines. She had a margarita the week before the vaccine that had some lemon juice in it, and she had rectal bleeding for a few days. She also had a severe reaction to some eye drops 4-5 years ago, she does not know the name of the medication, just that it was a generic. Half an hour after putting it in one eye she said it felt like her head was going to explode and thought she was going to die. The ambulance was called but refused to go in and had her friend take her in. She also experienced vomiting and diarrhea. On 16May2021, the day after the shot (Covid vaccine) she had some rectal bleeding similar to a light period but only for one day. She also had the shot in the left arm but had a sensation/pain in her right arm that went away quickly. The patient was unsure if that happened because she also had 2 margaritas and they made it with lemons which she is allergic to so it might have been that. The patient asked if the vaccine have any vinegar or wine in it. The patient also asked if she could get the second dose of the vaccine if she's had a severe reaction to some eye drops 4-5 years ago. She doesn't remember name of medication but had severe side effects including her head felt like her head was going to explode, vomiting, and diarrhea. The outcome of event rectal bleeding was recovered on 17May2021, while the outcome of event sensation/pain in her right arm was recovered on an unspecified date.
79 2021-06-09 unresponsive to stimuli Patient was found unresponsive "guppy breathing" at home on 6/7/2021. Intubated by EMS at home, admi... Read more
Patient was found unresponsive "guppy breathing" at home on 6/7/2021. Intubated by EMS at home, administered rapid SARS-CoV-2 test in field which resulted as positive. Admitted to ICU on ventilator. Remains in same condition as of reporting date (6/10/21).
79 2021-06-10 weakness 2d dose: Covid19(Pfizer-BioNTech), Lot EL1283given by injection, Left Arm, Feb 3, 2021, 3 PM. Pt wal... Read more
2d dose: Covid19(Pfizer-BioNTech), Lot EL1283given by injection, Left Arm, Feb 3, 2021, 3 PM. Pt walking stamina declined over the next week. Prior to second dose, she could walk about 1.25 miles; afterward her stamina declined to a few blocks distance. On Friday, Feb 12, Pt collapsed after bath. Saturday, Feb 13, 2021, Pt did not get up. Began episodically screaming in pain. Ambulance to Hospital. Admitted and given emergency pericardial window to address pericardial effusion. Pt was discharged Feb 19, 2021, diagnosed with 1:Cardiac tamponade; 2:Hypotension; 3:Sepsis; 4:Acute kidney injury. Slowly Pt recovered some ability to walk but as of June 11, 2021 her distance has not exceeded 0.25 mile.
79 2021-06-10 pain in extremity eyes really burning and watering, she almost could not see; eyes really burning and watering, she al... Read more
eyes really burning and watering, she almost could not see; eyes really burning and watering, she almost could not see; she almost could not see for a few minutes; Tiredness; excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand; red mark about the size of a quarter at injection site; couldn't move her fingers; This is a spontaneous report from a contactable Nurse. A 79-year-old female patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EW0150; Expiration Date: 31Jul2021), dose 1 intramuscular, administered in Arm Left upper on 24May2021 11:30 AM (at the age of 79-year-old), as 1st dose, 0.3 ML single dose, for COVID-19 immunization. Medical history included first pulmonary embolism in 2007; second in 2017 Went to hospital 23Jan2017, left hospital 5 days later. Patient has allergy to aspirin from Dec1982 to ongoing. (Patient Had headache, took Aspirin in 20 minutes had severe reaction-like never seen. Did not go to hospital, never felt throat closing off, coughing, trouble breathing. Skin felt on fire inside and out, took everything off, ice cold shower, skin beet red felt on fire all over, skin looked like elephant skin, wavy; Neighbor nurse gave her liquid Benadryl she drank. Within 15 minutes everything started to clear up, never been near Aspirin again). Patient has allergy to Advil from 1985 To Ongoing. (Had Severe reaction. Did not go to hospital, never felt throat closing off, coughing or trouble breathing. Couple years later had new job picked up fever from little kids coming in. Took Advil had reaction started the same way as with Aspirin, but she had Benadryl at home and able to catch it in time. Never taken again). Patient has allergic to other things, has environmental allergies. She kept Benadryl in her purse. Patient had Gall bladder surgery from 1985 to Unspecified date. (When had gall bladder taken out, they gave her Percodan and Percocet in hospital, had reaction of rash so they had to take her off Percodan and Percocet and give her Benadryl). Patient had Titanium filter in place from 24Jan2017 to ongoing. On 23Jan2017, patient was hospitalized because she could not breathe with pulmonary embolism, they put titanium filter in place probably after midnight so on 24Jan2017. Patient had lumbar stenosis with pinched nerve from 49 years of being a nurse. A few years ago, she had 2 procedures where they would inject long-acting unknown product, she guesses Cortisone but did not know the name of the product she guesses Cortisone but does not know the name of the product. On her right hand the numbness was still there. Patient underwent EMG test and a couple weeks later he told her he thought she has carpel tunnel. The concomitant medications include Eliquis taken for pulmonary embolisms (2.5 mg, 2x/day) from unspecified date of Jan2017 to ongoing. Synthroid taken for thyroid problem from unspecified date to unspecified date. Eliquis has to be a pretty powerful drug; don't know about Pfizer Covid Vaccines, wondered if something interacted because excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand and couldn't move her fingers took a little over 4 days after Pfizer Covid Vaccine for onset. The patient previously took (years ago) hepatitis vaccine, shingles vaccine, pneumonia vaccine, no reactions to those; she was very cautious did not leave the office too soon after vaccines. She never got flu shot; when she was first in nurses training, she had a reaction to the flu vaccine in like 1960 and was in the emergency room. This retired Registered Nurse was the patient who called regarding her first dose of Pfizer Covid Vaccine. She reported tiredness; eyes really burning and watering, she almost could not see; excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand; She couldn't move her fingers. She also mentioned red mark about the size of a quarter at injection site. She reported she had absolutely no symptoms, nothing after the Pfizer Covid Vaccine other than tiredness, feeling kind of tired, that's about it. On27May2021 in the afternoon she had onset of her eyes really burning and watering, she almost could not see for a few minutes. She washed her eyes out, and the burning and watering went away after she washed them. She had no make-up on, no eye make-up on for a few days at that time. Otherwise, everything was ok. She went to bed last night and during the night she woke up with excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand. She couldn't move her fingers for maybe a minute or two. Eventually she was able to move her fingers a little, then more and more and the event stopped, she kind of went back to normal and fell asleep. A couple of hours later she had the same event reoccur, just down to the hand, all 10 fingers, couldn't move them for a few minutes and then after that she could, they seemed to be ok, and she fell asleep again. Whether event started 27May2021 or 28May2021 is unknown, unknown onset times. She has been fined all day. She has written checks out, made meals, coffee, washed and dressed herself, had no other problems. At her age it was hard to tell when the tiredness started regarding time of onset. Thinks in the evening of 24May2021 she felt onset, tired and the next day on 25May2021 she had a couple episodes where her arms felt really heavy just for a short time maybe 30 seconds and then the episodes went away and she just felt tired. 26May2021 she noticed she was not as tired, and yesterday and today improved, feeling pretty good. Seriousness of all the events was not specified by reporter. The outcome of the events eyes really burning and watering, she almost could not see for a few minutes was recovered on 27May2021. Time of onset: late morning, probably about 11:00-11:30 really burned, then eyes started to really, really water. She was familiar with her house so she held onto furniture to get to the bathroom and as soon as she rinsed her eyes out event never happened again. Her eyes are not bothering her.The outcome of excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand and couldn't move her fingers was resolved on an unspecified date in 2021. The outcome of the event tiredness and red mark about the size of a quarter at injection site was recovering. Follow up attempts are completed. No further information is expected.; Sender's Comments: Based on close temporal association the causal association between the reported event she almost could not see for a few minutes with the usage of the vaccine BNT162B2 cannot be excluded. The contributory effect of the patient's medical history and concomitant medications also need to be considered. The case will be reassessed should the additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
79 2021-06-14 tingling paresthesia up and down body about one and a half hours after vaccine administration
79 2021-06-16 migraine 6 migraines after the first vaccine/Increased migraines; Dizziness; This is a spontaneous report fro... Read more
6 migraines after the first vaccine/Increased migraines; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: GR8736 or GR8136), via an unspecified route of administration, administered in Arm Left on 04May2021 (at the age of 79-years-old), as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included chronic migraine which she had them for years and then 5 years ago they came back with vengeance, herpes zoster from 01Feb2021 had shingles on her head and shingles pain. The patient's migraines got worse when she lost her husband 3 years ago, she thought it a stress migraine. The patient previously took amoxicillin and experienced drug hypersensitivity and botox for the past year for migraines. The patient was having around 8-10 migraines a month prior to starting Botox. The patient was late to get her dose of Botox because of covid and would have to go into the fourth month before she could get it instead of the usual 3 months. The Botox didn't seem to cover the patient with the vaccine. The patient was due 12Jul2021 for the next dose of Botox, but she had these migraines before then. The Botox had been working very well for the patient prior to the vaccines. The patient didn't know why the last dose of Botox didn't cover her like it usually does. The Botox dose was 125 units. They start on the lower dose and up it and see how you're doing, the highest was 150. Concomitant medications included gabapentin taken for herpes zoster from an unspecified start date to 28May2021; ibuprofen taken for shingles pain from 12May2021 to 28May2021. On 04May2021 (10 minutes after vaccine), the patient experienced dizziness and waiter for 30 minutes and then it went away. On 05May2021, the patient experienced first migraine after vaccine, had migraine yesterday and had migraine brain. The patient had 6 migraines after the first vaccine and 8 migraines after the second dose. The outcome of the event migraines was not recovered and for event dizziness was recovered on an unspecified date. Information on lot/batch number has been requested.
79 2021-06-16 pain in extremity headache; some soreness in her arm and it kind of went up to her shoulder; little bit of soreness in... Read more
headache; some soreness in her arm and it kind of went up to her shoulder; little bit of soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0153) via an unspecified route of administration, administered in left arm on 03Jun2021 13:00 (at the age of 79-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included her first cataract surgery on her right eye, and they found out she had glaucoma. She got a slight infection which is unusual after cataract surgery. She weighs around 188. She is trying to be healthier in general. She had so much going on in 2020, like everybody else. Her sister was really ill and she passed away She and her daughter were planning to fly in August and wanted to be fully vaccinated before they fly. She had been through this before as a child when she had the polio vaccine and there are people she knows got polio who are still affect by it as adults. She is also on blood thinners. She got good reports from her eye doctor. She had no eye pressure. A couple days later she saw her primary doctor and everything was good there. She sees her cardiologist on 17Jun2021. The main thing is she had been on blood thinners since Apr2017. She hopes she doesn't have to be on them for the rest of her life, but it's a possibility. She has to take that twice a day. She also takes a high blood pressure medicine and thyroid medication. She was told to tell the nurse to use a smaller needle. She has arthritis in both of her knees which is kind of hereditary. She had a fall after the campfire. They evacuated, and when they came back and fell in a store. She is getting physical therapy. The Pradaxa is quite expensive. She takes it twice a day. She keeps a log. This medication can't have air reach it, so she can't use a pill box with that. She keeps a journal and logs her medicines. She takes eye drops for her glaucoma. She takes a drop in both eyes before bedtime. It gives it a chance to rest and for the drops to absorb. She stated that diabetes runs in her family. On 20Mar2021 she had her first cataract surgery, so they gave her anesthesia for that. Glaucoma, cataract, arthritis, fall. Concomitant medication(s) included dabigatran etexilate mesilate (PRADAXA) taken for anticoagulant therapy from Apr2017 and ongoing, unspecified high blood pressure medication, thyroid medication and eye drops for glaucoma in both eyes before bedtime which would give a chance to rest and for the drops to absorb. Historical vaccination included polio vaccine. On 03Jun2021, It started that day she had the vaccine. Her vaccine was at 13:00. It was 104 that day so she stayed hydrated and drank a lot of water. She came home and had a little soreness. She was surprised she didn't have any big noticeable difference. With her arm soreness she was surprised it hurt in her shoulder. If she touches the site she can feel that, but she was okay and was well. On 04Jun2021 she had a headache the next day, and she did take Tylenol. She tried to prolong taking the Tylenol because she heard not to take Tylenol before the vaccine or too soon afterwards to give the vaccine a chance to do its thing. She went ahead and took Tylenol and it worked. It kicked in, and her headache went away the same day. She heard from other people that is was a classic symptom. Her symptoms weren't something she had to stay in bed for. She had a little anxiety before she had the vaccine. She read up as much as she could and decided on Pfizer because she had spoken with other people who had Pfizer. She will continue to wear a mask, she is really good at that. Outcome of the event headache was recovered on 04Jun2021. Outcome of other events it was recovering. Information on Lot/Batch number was available. Additional information has been requested.
79 2021-06-20 weakness Pt w/hx significant for COPD (on 1L O2 a baseline) p/w cough, exertional dyspnea, and generalized we... Read more
Pt w/hx significant for COPD (on 1L O2 a baseline) p/w cough, exertional dyspnea, and generalized weakness since 6/7/21). COVID test positive on 6/10 despite receiving Pfizer vaccines on 4/5 & 4/27. Pt was admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. During admission received dexamethasone, convalescent plasma, remdesivir. Culture indicated pseudomonas PNA, but likely colonization given hx, however, due to illness and underlying bronchiectasis, was given cefepime. Hospital stay complicated by significant resistant hypercarbia and respiratory failure, pt placed on comfort measures given that death is imminent. Unfortunately, pt passed on 6/13/21.
79 2021-06-24 weakness calcified lump, left breast, inconclusive; weak; tired; chills; shortness of breath; Itchy lumps at ... Read more
calcified lump, left breast, inconclusive; weak; tired; chills; shortness of breath; Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear); Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear); lung nodule; This is a spontaneous report from a contactable consumer (patient). A 79-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EN5318), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 as single dose for covid-19 immunization at Hospital. Medical history included atrial fibrillation, mitral valve stenosis, COPD (chronic obstructive pulmonary disease), ,ggo's , asthma, Known allergies to various medications. Concomitant medications in 2 weeks included Atenolol, Digoxin, Atorvastatin, Eliquis, Lasix, k (Potassium). Patient did not receive any other vaccine in 4 weeks. Patient did not had COVID prior vaccination. Patient did not tested for COVID post vaccination. Patient previously received COVID 19, brand: Pfizer-BioNTechCOVID-19 Vaccine 1st dose in left arm with lot number EL3246 on 21Jan2021, at 10:45. In Feb2021, the patient experienced lung nodule. On 19Feb2021 at 10:00 patient had chills. On 19Feb2021, the patient had Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear). On 19Feb2021 at 10 PM the patient had shortness of breath, abating at 4 am. On 20Feb2021, the patient was weak and tired but beathing easily. On 02March 2021, the patient had calcified lump, left breast, inconclusive. AE resulted in Doctor or other healthcare professional office/clinic visit. Lab test included patient had CT scan of lungs on 03Feb2021. On 05Feb2021 mammogram was done. On 09Feb2021 PET scan GGO change, upper left lobe confirms solidifying. On 02Mar2021 repeat mammo, results calcified lump, left breast, inconclusive. Bronchoscopy was scheduled for biopsy of GGnodule on 18Mar2021. On 19Feb2021 weight at 9 am was 127.5 lbs. On 21Feb2021 weight at 9 am was 120.0 lbs. Itchy lumps disappear 1 week. Treatment received was repeat mammo and biopsy of lung nodule. The patient was recovering for all the events while Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear) was recovered. No follow-up attempts are possible. No further information is expected.
79 2021-06-24 migraine muscle aches and pain; headaches; migraine; This is a spontaneous report from a contactable consumer... Read more
muscle aches and pain; headaches; migraine; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0169) via an unspecified route of administration (at the age of 79 years) on left arm on 26May2021 as dose 2, single for COVID-19 immunization. Medical history included, diabetes mellitus, high blood pressure, depression, thyroid disorder, all from an unknown date and unknown if ongoing. Past drug event was on Metformin for two years. Has been taking maybe 6 months, just refilled the second time, and it is every 3 months; Metoprolol ongoing has been taking quite a while, about 10 years, maybe not that long, so 5 years. Concomitant medications included chondroitin sulfate, glucosamine hydrochloride, manganese ascorbate (COSAMIN) taken for arthralgia from an unspecified start date and ongoing (It doesn't work right away, have to keep taking it. Has been taking a while and starts and stops taking it when she needs to. Generic, from (Withheld). It does work); hydrocodone (HYDROCODONE) taken for back pain from an unspecified start date and ongoing (Started quite a few years ago. Only takes a half of one, depending on the rate of pain. It is powerful stuff. Gets the prescription from the pain doctor and is monitored through the state of (withheld), sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]) taken for diabetes mellitus from an unspecified start date and ongoing (Has not been taking that long); ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) taken for an unspecified indication from an unspecified start date and ongoing, curcuma longa (TURMERIC [CURCUMA LONGA]) taken for an unspecified indication from an unspecified start date and ongoing, (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; carbinoxamine maleate (OMEGA 100) taken for an unspecified indication from an unspecified start date and ongoing, fish oil (FISH OIL) taken for an unspecified indication from an unspecified start date and ongoing; cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for thyroid disorder, start and stop date were not reported. Historical vaccination includes the patient received bnt162b2 on 03May2021 (1st dose Lot: ER8736 Anatomical Location: Arm left around 10:30 or 11:00) for COVID-19 immunization which caused mild pain after first shot. Patient is scheduled for a steroid shot 14Jun2021 and was told it was a two-week waiting period to obtain the steroid shot after receiving the second dose of the vaccine. The patient asked how long she should wait and stated she usually receives steroid injections and in which she tried to schedule her injections and was told to wait two weeks and do not want it to weaken my immune system. On an unspecified date May2021, about 4 or 5 days after second dose patient experienced muscle aches and pain It was maybe 4 or 5 days after the second shot. It lasted for about a week and was very painful. Thinks it may be an everyday thing with elderly people., headaches, she woke up on the 4th or 5th day with it. She does have headaches but not like that one. It was like a migraine type of headache. The muscle aches and headaches occurred at the same time. She takes supplements as treatment and is supposed to get another shot this week. She will go with the one that hurts the most. The patient was scheduled to have a steroid shot 14Jun2021(Monday) and asked how long she should wait for the steroid shot and her knees have been bad, so she is going in for steroids. The patient had blood work every 3 months for diabetes and have been normal. The patient underwent lab tests and procedures which included blood test result as normal. Referred caller to HCP and provided information that it is not a contraindication to receiving the vaccine. The clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) reporter/drug, different AE/ patient
79 2021-06-24 pain in extremity mild pain after first shot, as soon as she got the shot, she kept exercising her arm; mild pain afte... Read more
mild pain after first shot, as soon as she got the shot, she kept exercising her arm; mild pain after first shot; This is a spontaneous report from a contactable consumer(patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8736, Expiration date: Unknown), via an unspecified route of administration in left arm, high up in arm on 03May2021 around 10:30 or 11:00 (at the age of 79-year-old) as a single dose for COVID-19 immunization. Medical history included diabetes (under control, under 7), high blood pressure and knee surgery (her knees have been bad, so she is going for steroids. So many of her friends and relatives had knee surgery and it was botched so, she has continued with the shots and her knees hurt so bad), thyroid condition, blood pressure abnormal, chronic back condition from car accident, depression and she doesn't have a lot of energy. Concomitant medications included chondroitin sulfate, glucosamine hydrochloride, manganese ascorbate (COSAMIN) taken for joint health, for her knees and it doesn't work right away, have to keep taking it. Has been taking a while and starts and stops taking it when she needs to, hydrocodone taken for chronic back condition from car accident and started quite a few years ago. Only takes a half of one, depending on the rate of pain. It was powerful stuff. Gets the prescription from the pain doctor and was monitored, sitagliptin (JANUVIA) taken for diabetes mellitus and has not been taking that long. Was on Metformin for two years. Has been taking maybe 6 months, just refilled the second time, and it was every 3 months, metoprolol taken for blood pressure abnormal and has been taking quite a while, about 10 years, maybe not that long, so 5 years, vitamins nos (MULTIVITAMINS), curcuma longa (TURMERIC), ascorbic acid (VITAMIN C), fish oil (OMEGA-3 FISH OIL) and still ongoing, cyanocobalamin (B12 ) taken for thyroid condition and sometimes, the doctor gives her a shot that has multivitamin and B12, gives her a boost. Patient takes vitamins for depression and she doesn't have a lot of energy because of her thyroid condition, she was on B12. Patient has blood work every 3 months for diabetes and have been normal. The patient did not receive any vaccine, within 4 weeks prior vaccinations and not had any vaccines in a while, at least 6 months. On 03May2021, the patient experienced mild pain after first shot, it was awful. As soon as she got the shot, she kept exercising her arm. With the first one, she just kept putting ice on it when it hurt, then it went away. Events did not result in emergency room or physician office. The outcome of the event mild pain after first shot was unknown, rest of the event was recovered on an unspecified date in 2021. Information on Lot/Batch number was available. Additional information has been requested.
79 2021-06-28 tingling It started with a "tingling" feeling starting at the top of my head and going down to my feet. For ... Read more
It started with a "tingling" feeling starting at the top of my head and going down to my feet. For a period of time, I was unable to move - my legs week; could not stand. I could not move my fingers and hands. I felt like I was "out of my body" It was very frightening.. After about an hour, all my feeling came back to my body; I was able to walk (not very confidently yet)). I was weak for several hours.
79 2021-06-30 burning sensation, pain in extremity This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration in arm left on 06Mar2021at 11:00 (at the age of 79-year-old) as single dose for COVID-19 immunization. Medical history of the patient included high blood pressure, sinus issues. Family Medical History included that her daughter has had reaction to medications, she had flu vaccine and she ended up in the emergency department, she had trouble breathing. Concomitant medications included atenolol started a long time ago taken for high blood pressure. Patient previously used clindamycin as in her age she occasionally breaks. Patient previously received flu vaccine in 2009 for immunization and had a reaction. She had the Flu vaccine for many years and the one she had trouble with was a vaccine without preservatives. On 06Mar2021, seven hours after receiving first dose of vaccination, in the evening patient noticed that her mouth started to burn, accidentally pinched her arm and the pain was more than expected and it left a bruise. On 12Mar2021, patient experienced sinus issues. On 20Mar2021, patient experienced that her legs were heavy and felt like they were weighted, which made it difficult for her to walk. On 22Mar2021, patient experienced burning pain on her lower lips, specifically in the space between the lip and the teeth. There was also burning pain in the face, in the arm and her neck-chest area, which caused great mental distress, a huge emotional toll, specifically being upset and devastated, lack of sleep, and weight lost due to lost of appetite with 5 pounds being lost within 2 weeks of these side effects. On an unspecified date in 2021, patient experienced hypersensitivity reaction. Patient stated that when she was changing her outfit she accidentally pinched her arm and the pain was more than expected and it left a bruise. About 7 hours after, she noticed that her mouth started to burn. She mentioned that she also had pineapple that day and was not sure if it was caused by the vaccine. On the 09Mar2021, she consulted a nurse practitioner who said that the burning may have been caused by the Pineapple. On 10Mar2021, she consulted her allergologist and got tested for a pineapple allergy. The results came in on 15Mar2021 and they came back negative for the allergy, but her allergologist mentioned that pineapple can still irritate the mouth. On 18Mar2021, she consulted with her Primary in which she was given magic mouthwash that made it worse. She was made to continue her benadryl and aspirin spray. On 20Mar2021, that Saturday night, as she was walking, she felt that her legs were heavy and felt like they were weighted, which made it difficult for her to walk. It lasted for about 20-30 minutes before subsiding. Last Monday, 22Mar2021 she really started to notice the burning pain on her lower lips, specifically in the space between the lip and the teeth. There was also burning pain in the face, in the arm and her neck-chest area. She described it as not constant but comes and goes. On 25Mar2021, she consulted with her primary again in which she was recommended not to get the 2nd dose of the vaccine and her side effects lean to a more neurologic cause. The doctor mentioned that the vaccine was still too new. These side effects has caused great mental distress, a huge emotional toll, specifically being upset and devastated, lack of sleep, and weight lost due to lost of appetite with 5 pounds being lost within 2 weeks of these side effects. She said that has not been fun. it has been horrible, and she would choose dying over this burning sensation in the mouth. Patient visited physician Office, 3 times and allergist did it virtually. Reportedly, after eating dinner she was eating pineapple from a can. She had the can and tried it. She had not had pineapple in a long time. While sitting in her recliner, she experienced her mouth burning. She added that began about an hour and a half after eating the pineapple and it has lasted for approximately 2 weeks. It was not constant all the time. She did not know at the time if the burning in the mouth was related to the pineapple. Caller added they thought it was the pineapple causing this. Last Sunday, the caller indicated that it was leaving and going away. Caller saw her new primary medical doctor on 09Mar2021. The Nurse Practitioner said it was probably the pineapple, She started her on Benadryl. Manufacturer was unknown to caller. Caller took 2 tablets on 09Mar2021 and stopped taking it on 10Mar2021. She restarted taking the Benadryl on about 14Mar2021. Caller stated she was primarily calling and asking because on Monday, 22Mar2021 she started having burning in her face and had burning in her arm. Caller reported the burning in her arm was not from the vaccine and she thought it was caused by her blood pressure cuff. Caller took her own blood pressure. Burning was better today, she still had burning in her arm. She took Zyrtec as instructed by her physician twice a day. She took a half tablet on 10Mar2021 through 13Mar2021. She was taking half a tablet in the morning and a half tablet at bedtime. Caller added that the Zyrtec made her feel unsteady and it made her sleepy. She did not tolerate it. Dose was 10mg. She has recovered completely from unsteady and being sleepy with Zyrtec. Caller took Tylenol because she was having sinus issues. She did not have the manufacturer, she took it on 12 and 20, two times. Its 325mg, by mouth, the regular strength. Caller saw an allergist on 10Mar2021 who tested her for pineapple allergy. The Allergist called on 15Mar2021 and reported she was not allergic to pineapple. Allergy was also tested for egg white, milk, wheat, corn, peanut, soybean, potato, yeast, and tomato. All resulted as negative. Benadryl: took 2 times in 09Mar2021. Caller restarted Benadryl and took it on 14Mar2021-17Mar2021. These days she only took it in the evening. She took 25 mg at night. Then she took Flonase, twice, on the 17th and 18th. Its over the counter. Lot number: TE8G, caller doesnt have box to provide UPC, stated there was another number of 0140592, expiry Mar2021. Dose was 27.5mcg per spray, spray into each nostril. When providing strength, states writing was so small for her to see. Gets a magnifying glass to confirm strength, states it's with her age. The doctor also suggested for the caller to try Afrin spray on 18Mar2021. Caller started it on 20Mar2021 and used it only once. She didnt like it. Caller said at her age she occasionally breaks out and uses Clindamycin for that. Dermatologist has her using Clindamycin 1 per cent pledgets. Applied twice to face once daily, She stopped 20Mar2021. Given Magic Mouthwash, which was in a pharmacy bottle, she took it once on 18Mar2021, but stopped. It was 5-10ml swish and spit. It made things worse and did not improve it. The doctor forgot to give her a measuring cup, and caller thought she told her a teaspoon. Caller added she tried using a warm cloth on her sinus area and her skin felt like a sunburn. The cloth left a red area around her cheek. Then this Sunday, after using the pledgets, went for a walk, next day noticed her face was really burned, not just face, her neck, arms, but she was not exposed, but had a burning pain, and she still continued to have it. She asked the dermatologist if this could be caused from the Clindamycin. The dermatologist told her no. She took a walk on Saturday and did not know if she was dehydrated. She felt like there were weights on her feet as she walked. It lasted 30 minutes. The burning in mouth started 7 hours after the first dose and it had improved. Therapeutic measures taken in response to the events included Benadryl, Zyrtec, Tylenol, Flonase, Afrin spray, clindamycin, magic mouthwash. Outcome of the events "mouth started to burn/burning in mouth" and "sinus issues" were ongoing-not recovered and for all other events were unknown at the time of report. Information on Lot/Batch number has been requested.
79 2021-07-07 pain in extremity, night sweats full blown tinnitus; some ringing in my ear on and off; not much sleep; ear felt full; sore, painful... Read more
full blown tinnitus; some ringing in my ear on and off; not much sleep; ear felt full; sore, painful glands neck & base of skull; woke with night sweats; mild arm soreness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 79-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration, in arm right on 26Feb2021 at 17:30 (at the age of 79-years-old) as dose 2, single for covid-19 immunisation. The medical history of the patient included High blood pressure - controlled (hypertension) from an unknown date and unknown if ongoing. The concomitant medications of the patient included levothyroxine sodium (SYNTHROID), losartan, verapamil, colecalciferol (D3) taken for an unspecified indication, start and stop dates were not reported and tumeric. The past drug history of the patient included allergy to penicillin. The patient previously received first dose of BNT162B2(solution for injection, Batch/Lot number: EL9269), via an unspecified route of administration, in arm right on 03Feb2021 at 06:45 PM (at the age of 79-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient not been tested with covid-19. The patient experienced mild arm soreness on 27Feb2021 at 21:30, woke with night sweats and sore, painful glands neck & base of skull on 10Mar2021 at 21:30, ear felt full on 12Mar2021 at 21:30, some ringing in my ear on and off and not much sleep on 14Mar2021 at 21:30 and full blown tinnitus on 15Mar2021 at 21:30. The reporter stated that she called her doctor she said there was nothing to be done for it and also stated that tinnitus 24/7; glands sore; ear still wonky (technical term). The events did not result in death or Life threatening or caused/prolonged hospitalization or disabling/incapacitating or congenital anomaly/birth defect. The events are reported as non-serious by the reporter. No treatment was received. The outcome of the events was reported as not resolved. Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
79 2021-07-09 depressed level of consciousness On February 18, 2021, three days after receiving the Pfizer vaccine, patient was rushed to the emerg... Read more
On February 18, 2021, three days after receiving the Pfizer vaccine, patient was rushed to the emergency room with rapidly dropping blood pressure and difficulty keeping conscious. After being in COVID isolation for 24 hours, I saw her in a hospital bed and she looked like a corpse. The initial diagnosis was severe Sepsis with liver, kidney and heart problems and blood clots in both lungs. She had never had any of this before getting the Pfizer vaccine. Her WBC count was also very high. She was hospitalized for 10 days and then sent to a rehab facility for 14 days before returning to her independent living facility. She is now taking blood thinners for the blood clots which she didn't have prior to taking the vaccine. He did a miracle in sparing her life!
79 2021-07-11 pain in extremity Well like I said, I woke up and my arm after the shot was sore. The joint was bothering me, and I th... Read more
Well like I said, I woke up and my arm after the shot was sore. The joint was bothering me, and I thought that it was a side effect of the shot and after about a week I had a little bit of movement but still pain. So later in May I finally called the orthopedic doctor. I got an MRI and he said it was a significant tear to the rotator cuff. I did not do anything so I do not know what or how it happened. I just figured it was the COVID vaccine, although the doctor thought it was highly unlikely. I had surgery to repair it on May the 20th 2021, at local hospital. I came home that night after the surgery. The doctor gave me tramadol for the pain as well. I will have another MRI next week, in mid-July 2021.
79 2021-07-12 weakness she can't lift anything/Patient states she couldn't even roll over in bed, she just laid there like ... Read more
she can't lift anything/Patient states she couldn't even roll over in bed, she just laid there like she was dead; muscle and body pain; body pain/ in a lot of pain; shortness of breath; headaches; lightheadedness; weakness; tiredness; chills; joint pain; nausea/Really Bad Nausea; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; weird bumps on her arms that were itchy but now are not; sore throat; she feels like her throat and neck is swelling and tight; weird bumps on her arms that were itchy but now are not/weird bumps on her arm; bone pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0171) via an unspecified route of administration, administered in Arm Left on 09Jun2021 (79-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included ongoing she is disabled and has been disabled for 27 years. Patient states she lost 14 pounds in the last 3-4 weeks, but that was before the shot. The concomitant medications were unspecified. Historical vaccine included flu shot When she gets the flu shot, she can get symptoms for about a week. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. No prior vaccination within 4 weeks. The reporter reported that, she received her first dose of the Pfizer Covid-19 vaccine on 09Jun2021, and then on 10Jun2021 she experienced Muscle and Body Pain, bone pain, sore throat, shortness of breath, headaches, light headedness and dizziness Really Dizzy; didn't know if she was walking forwards or backwards, Weakness; she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it; couldn't hold a pencil, tiredness, chills, joint pain and in a lot of pain, and Really Bad Nausea. The reporter stated that when the patient lays down it feels like her throat and neck are swelling and tight, and she also has weird bumps on her arm, the itching is gone but she can still feel the bumps. she couldn't even roll over in bed, she just laid there like she was dead. The reporter stated the patient is not getting the second dose and not going to the hospital. The reporter asked how long do these symptoms normally last, it's already been two weeks. The reporter asked, "If she can't take the second shot, can the doctor give her a clearance for that, Some places are forcing people to take this." Patient is in the background on speakerphone and states she is not going to the hospital, so forget that. The reporter stated the patient also has weird bumps on her arm, the itching is gone but she can still feel the bumps. The reporter stated that the side effects started on 10Jun2021. Patient states the bone pain lasted a week and a half and then every day something new came, they were kind of sporadic. Patient stated that she has the bumps on her arm, and everything except vomiting, if vomits she is in trouble. Patient states her bones are better some, but the weakness is there, she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it and she still gets dizzy. The reporter stated there are so many different side effects that they are unsure of when each one started and stopped, but most of the side effects are ongoing. Patient stated there is no way anyone will get her to go to the hospital but she just wanted to know how much longer is this going to go on. Patient stated last night she didn't know if she was walking forwards or backwards and she was so weak she couldn't pick up a pencil. Patient stated in the morning she thought she is still alive, she couldn't believe it. Patient stated she will not have the second shot, she cannot. Patient states she can't go through that again, she would rather die. Patient stated she couldn't even roll over in bed, she just laid there like she was dead. Patient states she has had a hard life but never like this. Patient stated she takes a lot of medications but she has been taking them for years and there are no medications or medical conditions that she feels are relevant. No treatment received for events. The outcome of the event muscle and body pain, body pain/ in a lot of pain, weird bumps on her arms that were itchy but now are not, bone pain were resolving and events were not resolved. Information about lot/batch number was provided. Additional information has been requested.
79 2021-07-13 numbness Patient reports started having weakness and numbness in feet in mid March 2021. She reports she saw ... Read more
Patient reports started having weakness and numbness in feet in mid March 2021. She reports she saw a neurologist and was diagnosed with Guillian Barr Syndrome on 06-15-2021. She reports her weakness is improving with Physical Therapy. She received her first dose of COVID 19 Pfizer vaccine on 01/25/2021.
79 2021-07-13 muscle spasms first shot gave her lots of energy 2nd shot - arm tiredness, muscle cramps and fatique
79 2021-07-13 tingling, tremor, flushing New onset tremors, feeling of flushing, tingling throughout body
79 2021-07-17 weakness, feeling cold, feeling hot gets hot and then cold and sweating; gets hot and then cold and sweating; gets hot and then cold and... Read more
gets hot and then cold and sweating; gets hot and then cold and sweating; gets hot and then cold and sweating; She states the nausea was slight after the first dose but more so after second shot.; headache; not feeling well; no energy; She states after the second shot, her tiredness is worse; She stated after the second shot, her tiredness was worse; Blood pressure high; Fever; Nose bleeds; Severe Chest Pain, fluttering feeling, feels little things; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 13Mar2021 at 10:15 (at the age of 79-year-old) as dose 2, single for COVID-19 immunisation at "PRIVACY" where doctor offices older buildings are. "PRIVACY" now has brand new office, old used for shot and doctors. Medical history included diverticulitis from 2016 and ongoing (she changed her diet. No greasy, no fried, no spicy foods. 2017 attack, 2018 or 2019. Stated that she has felt fine ever since), booster from an unknown date and unknown if ongoing (She stated about 5-6 years ago, she had boosters from childhood shots, every booster. Never had the shingles shot. She stated she has never had a reaction from any of it). Historical vaccine included A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in left arm on 19Feb2021 (at the age of 79-year-old) as dose 1, single for COVID-19 immunisation at "PRIVACY" where her doctor was located, her office was upstairs (the nurses had people spaced downstairs) and experienced a lot of face redness, severe chills, nausea. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that she stated that about a week before the second vaccine she was not sleeping well but she had started to feel better but then she got the second dose and that was a whammy. She stated that when she got the first shot, it kept her awake, like she drank 20 cups of coffee, but after 24 hours, she was just exhausted. She has always been energetic and none of that anymore. She stated after the second shot, her tiredness was worse. She gets exhausted doing nothing. She stated that it was on and off nausea where some mornings felt ok, others she felt nauseated. She does not know if it was the blood pressure pill or not, she was not used to taking any meds. She would probably call the doctor "today" and tell them. She was not used to not feeling well. The patient stated that on 17Mar2021, she got a nosebleed, but she was able to control it and had fever. She called her doctor and told her about the chest pain and nosebleed. She stated the nausea was slight after the first dose but more so after second shot. She was more aware of not wanting to eat and feeling nauseous. She was being cautious because it was so profuse on "Sunday" 21Mar2021 and her blood pressure was so high. "Now", she was on a blood pressure pill and she hopes she does not have another nosebleed. She stated that it was a fluttering feeling, and she can feel little things. It was started testing her blood pressure when it went up on the 17Mar2021. It was 122 and 131. Then on 20Mar2021, it was 174/77 in the "evening" and on 21Mar2021, it really shot up and she went to the hospital and there it was 197/93. She stated that on the 17Mar2021, she was not feeling well and on 18Mar2021, she called her doctor and they told her to stay hydrated and take her blood pressure. She stated then on 21Mar2021, it got really bad. She stated with the medication since the 21Mar2021 "Sunday". On 22Mar2021, it was 156/91 and 128. It was 107/64 "yesterday" and "now" 117/75. She stated that it seems to be back down where it usually has been, more towards lower rather than the higher reading. She has never experienced high blood pressure. She stated that the ER (emergency room) doctor said her problem was high blood pressure and you have had for years but she states she has not. She stated in 2016, she went to the hospital for a diverticulitis attack and then it went back low again at doctor office. In 2017, she went to the ER (emergency room) with diverticulitis. She stated the ER (emergency room) doctor was looking at the blood pressures from times when she was in the ER (emergency room) in 2016, 2017, and 2018 or 2019. She stated that after the ER (emergency room), she always maintained her blood pressure, but he put her on a blood pressure pill, but she was questioning it because she has always maintained low BP. She has never had high blood pressure in her life, it always runs low. On 21Mar2021, emergency room doctor said her blood work for her age looks very good and she really was very healthy. She was thinking, then why was she there. Stated her blood work looked very good and she looked very healthy. The patient was received the treatment in ER (emergency room), Amlodipine, talked to nurse yesterday afternoon and she asked how she was feeling, not like feeling bad, no energy. They gave it to her IV (intravenous) to bring her blood pressure down on "Sunday" (21Mar2021). " Physician office: Followed Up with Phone Calls, 06Apr2021 she has a follow-up appointment ". The patient underwent lab tests and procedures which included blood pressure: 174/77 (unknown units) on 20Mar2021, 197/93 (unknown units) on 21Mar2021, 156/91 (unknown units) on 22Mar2021, 107/64 (unknown units) on 23Mar2021, 117/75 (unknown units) on 24Mar2021. The outcome of fever was resolved on 17Mar2021, nose bleeds was resolved on 21Mar2021; Severe Chest Pain, fluttering feeling, feels little things, Blood pressure high, her tiredness worse, Nausea aggravated was not resolved; gets hot and then cold and sweating, headache, not feeling well, no energy, was unknown No follow-up attempts are possible. No further information is expected.
79 2021-07-17 hot flush Hot flashes; This is a spontaneous report from a contactable consumer or other non healthcare profes... Read more
Hot flashes; This is a spontaneous report from a contactable consumer or other non healthcare professional. This is the first case out of two cases in which the reporter is reporting for herself. A 79-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration on 09Jan2021 as dose 1, single and received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9267) via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that she never had hot flashes like am having now, when are you going to tell the public about your adverse experiences with this shot. It is not safe, please get it out there, the people know what they are getting into and I had my 1st shot January and my 2nd shot in February and I have been having hot flashes and hot flashes and more hot flashes on Jan2021 and also my husband is having hot flashes from the shot and yes, the Covid vaccine gave me and my husband hot flashes. The outcome of the event was not recovered.
79 2021-07-20 pain in extremity shot was given around 11am and around 1-2 she began to get chills and body aches worse than covid, e... Read more
shot was given around 11am and around 1-2 she began to get chills and body aches worse than covid, exhausted, several weeks later she began to having issues with walking, she will get pains in her knees and legs, its hard to walk she begins to walk like a penguin, she is now using a cane.
79 2021-07-20 tingling, numbness numbness in fingers on both hands; pins and needles sensation in hands; This is a spontaneous report... Read more
numbness in fingers on both hands; pins and needles sensation in hands; This is a spontaneous report from a contactable consumer, the patient. A 79-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 24Feb2021 at 11:30 as a single dose for COVID-19 immunisation. Medical history was reported as no. Concomitant medications of the patient were not reported. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not tested for COVID-19. On 04Mar2021 at 07:00 the patient experienced numbness in fingers on both hands, pins and needles sensation in hands. The patient did not receive any treatment for events. Clinical outcome of the events numbness in fingers and pins and needles was unknown at the time of reporting. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
79 2021-07-22 hot flush Severe headache; Muscle aches; Feeling of unwell; Fatigue; Chills; Hot flashes; Nausea; This is a sp... Read more
Severe headache; Muscle aches; Feeling of unwell; Fatigue; Chills; Hot flashes; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 79-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the arm left on 12Mar2021 at 10:00 (at the age of 79-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic fatigue and grave's disease. The patient had unspecified allergy to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 10:15, the patient experienced severe headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea. It was reported that, the headache was absolutely severe to the point that it was hard to keep eyes open and see. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea. The clinical outcome of events severe headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea were resolved on an unknown date in Mar2021 (lasted 3 and half days). No follow-up attempts are possible; information about lot/batch number cannot be obtained.
79 2021-07-27 weakness first dose, dizzy; first dose, dizzy like all the energy went out of her foot; This is a spontaneous... Read more
first dose, dizzy; first dose, dizzy like all the energy went out of her foot; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6205), dose 1 via an unspecified route of administration, administered in Upper Arm Left on 26Apr2021 11:00 (at the age of 79-years-old) as dose 1, single for covid-19 immunization. The patient medical history included she was allergic to Penicillin. After taking that for about 50 years she had an allergy to the Penicillin vaccine, and she came home and she got hives on her chest and neck and up on her face. She confirms it was Penicillin vaccine. That has been about 20 some years ago. The patient had no other medical history. The patient had no family history. The patient's concomitant medication(s) included cyanocobalamin (VIT B12) taken for immune system disorder from Mar2021, ergocalciferol (VIT D) taken for an unspecified indication from Mar2021 and zinc taken for cataract, macular degeneration. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks) and any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse events following prior vaccinations. The patient took the first one 26May2021 and within an hour she got dizzy and like all the energy went out her foot and then she was over it, within 30 minutes she was fine and was like she never knew she took it after that. She is a mother and a grandmother, and a great grandmother and she debated about this because she was not too sure about it but she watched and listened every day at noon they talked about it and she does not think she would have survived if she got COVID. She confirms she got it for prevention of COVID. The adverse event not required visit to physician office and Emergency Room. She was thinking about going to doctor to see him, but she kept thinking she would start feeling better. She tries to walk every day. No relevant test done. She takes vitamins to keep herself healthy, she takes B12 and then she takes Vitamin D and Zinc. Zinc: She had problems with her eyes to start with. She confirms that's why she started the Zinc; she says she has cataracts and macular degeneration. She confirms she had those prior to using the Zine. She was going to have cataract surgery 04Aug2021. She just got this herself the doctor did not tell her to, she has enough trouble with her eyes. She takes it for her eyes, she has problems with her eyes. Vitamin B12: She was taking that way before the shot. She had a bone scan, and it showed her bones were deteriorating from get older so that is why she started taking it. Vitamin D: She says the bottle says 125 mg (5000 mcg). She says she started mar 2021 that was when she had her wellness check. No further information provided. The outcome of the events was recovered on 26Apr2021. Follow up is excepted. Additional information has been requested.
79 2021-07-27 pain in extremity Severe pain in her left leg; the pain is becoming increasingly difficult; Severe pain in her left le... Read more
Severe pain in her left leg; the pain is becoming increasingly difficult; Severe pain in her left leg; the pain is becoming increasingly difficult; This is a spontaneous report from a contactable consumer (patient's husband). This is the second report out of two split reports. A 79-year-old female patient received bnt162b2 (formulation: solution for injection; COVID-19 Vaccine manufacturer: Unspecified; NDC number, UPC number, expiry date and Lot number: Unknown), dose 2 via an unspecified route of administration, administered in left arm (at the age of 79 years) on 18Apr2021 as dose 2, single for covid-19 immunisation. Medical history included heart issues from an unknown date and unknown if ongoing and too many dimensions (not clarified) she had heart issues, mainly heart issues. The patient's concomitant medications were not reported. The patient historical vaccine included BNT162B2 dose 1 (lot number: ER8732) on 28Mar2021 for Covid-19 immunization at the age of 79 years. The patient's husband reported that his wife had the same shots, at different times of Pfizer and we were just beginning to explore what the issue was. She had severe pain in her left leg. After her second shot on an unknown date in Apr2021. Patient had been dealing with her primary care doctor. She had doppler on her leg because she had the similar pain in her left leg and it's not been resolved yet. This was an ongoing thing. So, she had now taken a doppler and the pain is becoming increasingly difficult, and she is in the process of evaluating what this is and gone down the emergency room the next day. The patient underwent lab test which included Doppler scan with unknown result in 2021. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
79 2021-07-28 feeling of body temperature change freezing with chills, and turned up the heat.; node on my arm; Adds her arm at the place where the g... Read more
freezing with chills, and turned up the heat.; node on my arm; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; freezing with chills; freezing with chills; Nausea; slight headache; This is a spontaneous report from a contactable consumer(Patient). A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:30 (at the age of 79 years) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration, administered on 01Mar2021 as single for COVID-19 immunisation. Patient states she had the second shot yesterday and adds she didn't have any side effects from the first one. After the second one, by 20: 00PM she had nausea for about an hours and a slight headache that went away by the time she went to bed. Then early the next morning she was freezing with chills, and turned up the heat. Adds she didn't have all that with the first one. Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it. She is asking is all this a normal side effect. Mentions she took her temperature and she doesn't have a fever. Patient Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 01Mar2021 in the afternoon in the left arm and the second dose on 29Mar2021 at 12: 30PM in the left arm. Patient further stated that "I got a node on my arm and it has fluid in it and I didn't have that before, so I'm concerned about it." The outcome of the events Nausea, slight headache was recovered on 29Mar2021 while the freezing with chills was recovered on 30Mar2021. While the outcome of the rest of the events were unknown. No follow-up attempts are needed. No further information is expected.
80 2021-01-13 slurring Patient presented herself to LPN slurring words and 'not herself'. Upon evaluation, patient denied d... Read more
Patient presented herself to LPN slurring words and 'not herself'. Upon evaluation, patient denied drinking alcohol, knew she was not able to speak correctly and visibly frustrated . With great difficulty she was able to communicate that she had a headache and was slightly dizzy. Failed FAST and does have a history of CVAs. EMS called and patient was taken to ER where they admitted her for observation post Stroke. Per the hosp nurse, patient received tPA treatment and will be moved to step-down unit when a bed is available.
80 2021-01-14 slurring 24Hr, 01/09/2021-post vaccine found in room on floor- very shaky and SOB, again later the same day-i... Read more
24Hr, 01/09/2021-post vaccine found in room on floor- very shaky and SOB, again later the same day-incontinent urine, confused, pain in extremities with movement, sent out to hospital. returned same evening. 01/12/2021- difficulty communicating, confused- sent out to hospital, returned same day. 01/15/2021- symptoms improved
80 2021-01-20 weakness Received Vaccine at about 9 AM 1/20/21. At 4 pm on 1/20/21 developed a raised rash that itched on up... Read more
Received Vaccine at about 9 AM 1/20/21. At 4 pm on 1/20/21 developed a raised rash that itched on upper body front, back and arms. Face not involved. Spoke with Dr. and ordered to take Benadryl and call PCP. I/21/21 Reported Benadryl was taken at 5 pm on 1/20/21and symptoms were relieved but returned at 9 pm 1/20/21. Took 2 more Benadryl. Reports no rash 1/21/20 but weak and tired.
80 2021-01-20 feeling hot About 20 minutes after receiving vaccine I felt a very hot area in the center lower part of my chest... Read more
About 20 minutes after receiving vaccine I felt a very hot area in the center lower part of my chest. It radiate it out and up into my throat. It only lasted a few minutes and completely went away. About seven hours later the same thing happened but the heat was not intense as it was the first time. Nail two days later, I have a slight, very slight feeling of heat in my lower throat. I?ve never had any of these symptoms before.
80 2021-01-21 flushing Within one hour- flushing, headache, and swelling and sore lymph node- right side. Over nite and f... Read more
Within one hour- flushing, headache, and swelling and sore lymph node- right side. Over nite and for 3 days fever of 100.2. Tired, skin hurt and sore throat- swollen lymph node lasted for 4 days.
80 2021-01-21 muscle spasms Extreme cramping in both legs, fainting
80 2021-01-21 pain in extremity lip swelling, left arm pain, hand pain/tightness
80 2021-01-24 flushing Pt. left POD after receiving vaccine and waiting allotted 15 minutes. Pt. then returned to POD clin... Read more
Pt. left POD after receiving vaccine and waiting allotted 15 minutes. Pt. then returned to POD clinic because was feeling flushed. Pt. also c/o headache. Pt. was noted to be very shaky and have elevated blood pressure upon assessment. BP: 198/92, rechecked 179/82, RR: 16, O2 sats: 98%. Assessed by local EMS. Pt. plans to follow up with PCP.
80 2021-01-26 burning sensation, flushing Burning sensation on my chest, back and face, flushed face on 1-22-2021, @2:30a, lasted for 15m, cam... Read more
Burning sensation on my chest, back and face, flushed face on 1-22-2021, @2:30a, lasted for 15m, came back on 24-27, feeling like after putting vicks vapo rub burning sensation.
80 2021-01-26 flushing, burning sensation On January 22,2021 @2:30a i woke up with burning sensation on my chest, back and flushed face, Janua... Read more
On January 22,2021 @2:30a i woke up with burning sensation on my chest, back and flushed face, January 24, 25 and 26, the same feeling, i saw my primary doctor January 26, that day @. 2:30 burning sensation on my chest, back and flushed face. I had an ekg that day and my doctor said it?s fine, today @6a, same reactions, episodes last for 10 minutes.
80 2021-01-26 tremor High fever 101.7 for two days. Extreme shakes all night on the25th. Advil taken every four hours. ... Read more
High fever 101.7 for two days. Extreme shakes all night on the25th. Advil taken every four hours. Stomach cramps and loose bowels the next day.
80 2021-01-29 tingling Itchyness on toes and tingling in fingers. Only lasted 10 or 15 minutes
80 2021-01-30 tremor Almost uncontrollable shaking, 2.3 degree increase in temperature, really bad diarrhea . Symptoms... Read more
Almost uncontrollable shaking, 2.3 degree increase in temperature, really bad diarrhea . Symptoms lasted around 12 hours, temperature came down in a day and I took Tylenol
80 2021-01-31 tremor day after injection i had slight head ache on Friday night i was shaking uncontrollably and then Sat... Read more
day after injection i had slight head ache on Friday night i was shaking uncontrollably and then Saturday i got nausea.
80 2021-01-31 tremor Patient began shaking, had shortness of Breath, Increased heart rate 148, low o2 sat 90 increased te... Read more
Patient began shaking, had shortness of Breath, Increased heart rate 148, low o2 sat 90 increased temp 99.5 respirations were 38 B/P 144/70 blood sugar 198
80 2021-02-01 pain in extremity I began with mild arm ache 24 hours after vaccination, 72 hours later the site became swollen, red a... Read more
I began with mild arm ache 24 hours after vaccination, 72 hours later the site became swollen, red and itchy. Overall I feel fatigued and lost my appetite. In addition when I had CoVID in September I experienced difficulty falling or staying asleep. I experienced that last night again. I am very tired but unable to fall asleep.
80 2021-02-01 pain in extremity 101F fever/101 degree fever; chills; headache; Sore arm; This is a spontaneous report from a contact... Read more
101F fever/101 degree fever; chills; headache; Sore arm; This is a spontaneous report from a contactable consumer reporting for herself. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via unspecified route of administration, on right arm, on 14Jan2021 15:30 at single dose for COVID-19 immunization. Vaccination Facility type was at Health department gave it at the fairgrounds. Medical history included ongoing COPD, blood pressure high, GERD, former smoker she quit 30 years ago, had COVID while she was in a rehab center in Aug2020, for which she said it felt like bronchitis; broke her hip last August (Aug2020). Ongoing concomitant medications included hydrochlorothiazide, telmisartan (TELMISARTAN HCTZ) for blood pressure high, pantoprazole for GERD, vitamins, ascorbic acid (VITAMIN C), zinc, colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN), magnesium. On 15Jan2021, patient had a 101F fever, a headache and chills all day. Her concern was that she had never had any kind of reaction to any kind of vaccine before. From what she's heard, people have had a worse reaction to the 2nd shot, and since the first shot was so bad she was worried about getting the 2nd one. She was scheduled for her 2nd dose on 02Feb2021, and she had an appointment scheduled with a specialist on 03Feb2021. The morning after getting the vaccine, she woke up and got dressed but kept thinking that she was cold so she put on an extra sweater. Stated that even with the extra sweater on, she still had the chills, then she started to get the headache, and then she took her temperature. Stated that she had also had a sore arm, it's finally starting to feel better today. The outcome of event sore arm was resolving, outcome of other events were resolved on 16Jan2021.
80 2021-02-01 unresponsive to stimuli Patient came back from cardiology appointment (at 2pm) unresponsive. It was reported that she had vo... Read more
Patient came back from cardiology appointment (at 2pm) unresponsive. It was reported that she had vomited while at the appointment. She was confused when she could be aroused, stating that she does not have a name.
80 2021-02-03 feeling cold, muscle spasms, pain in extremity, feeling hot Started not feeling right- her stomach was bothering her; diarrhea; Her face turned red; Face and ch... Read more
Started not feeling right- her stomach was bothering her; diarrhea; Her face turned red; Face and chest felt like they were on fire; Freezing and could not warm up; She was very crampy; nauseous; Left arm soreness; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247) solution for injection intramuscular in the left arm on 19Jan2021 (at the age of 80-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. On 19Jan2021, the patient started not feeling right- her stomach was bothering her, diarrhea, her face turned red, face and chest felt like they were on fire then freezing and could not warm up, she was very crampy, nauseous and left arm soreness. The outcome of the events stomach discomfort, diarrhea, feeling hot, feeling cold, very crampy and nauseous was recovered on 19Jan2021. The outcome of the event face turned red was unknown. The outcome of the event left arm soreness was not recovered.
80 2021-02-03 pain in extremity began to run a fever, so she had a COVID test which came back positive; began to run a fever, so she... Read more
began to run a fever, so she had a COVID test which came back positive; began to run a fever, so she had a COVID test which came back positive; her arm began to be sore; feels pretty crummy; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 likely around 2pm-ish at a single dose for COVID-19 immunization. Medical history included diabetic from 1993 to an unknown date. There were no concomitant medications. The patient called about the Pfizer BioNTech COVID19 vaccine and says she took the first shot on 07Jan2021, then one week later, 14Jan2021, she began to run a fever, so she had a COVID test on Monday 18Jan2021, which came back positive. She says she has had a fever at the time of report for the 7th day. The patient received the vaccine and doesn't know if she is willing to get the second shot after this. The patient was asking if it could be a false positive, can she take ibuprofen, can she take the second dose and could the vaccine cause coronavirus. She says that she got the first dose of the vaccine, it was injected into her left arm, and it wasn't painful, she felt so good, then night of 07Jan2021 her arm began to be sore, her vaccine arm was now ok, she started feeling sick a week later. She has been taking Tylenol only, since she heard that it is not good to take Ibuprofen. Tylenol EXP: Mar2024, LOT: SEA054, she says that the Tylenol is 325mg, and she has been taking two at a time, she takes it when she needs it for the fever, she tries to space out doses 5-6 hours. Her temperature on morning of 20Jan2021 was the highest it has been, 102.1 degrees Fahrenheit. She says she has kept a log, it has also been 101.4, 100.5, after it started out a week ago at 99.7, 99.1, 99.5, and then on Saturday, unknown date in Jan2021, it started climbing up, it has been 100.4 degrees Fahrenheit last two to three days and higher, she feels pretty crummy. She has had a positive COVID test which she took Monday 18Jan2021 and the results came back morning of 20Jan2021 on the phone, it is unknown which test exactly they used. She says it was the 2-3 day one with a swab, she did her own swabbing and swabbed each nostril with the same swab really well. The events were reported as non-serious. Outcome of the event her arm began to be sore was recovered in Jan2021, for the other events was unknown.
80 2021-02-06 weakness Fever (100.4 degrees), general weakness, headache, strong pain in the place of injection.
80 2021-02-06 fibromyalgia Extreme intensification of fibro and polymyalgia symptoms (almost unable to do anything). Need to u... Read more
Extreme intensification of fibro and polymyalgia symptoms (almost unable to do anything). Need to use a walker and still do. Also leg and foot swelling
80 2021-02-06 nerve pain Nerve pain day 2&3 Arthritic pain day 3&4 Sick sick sick day 4-6 oxygen level 75 percent Headache da... Read more
Nerve pain day 2&3 Arthritic pain day 3&4 Sick sick sick day 4-6 oxygen level 75 percent Headache day 10
80 2021-02-07 pain in extremity Amyloidosis; felt a sweep over her stomach up her body and up to her head; Eyes swollen; hands hurt;... Read more
Amyloidosis; felt a sweep over her stomach up her body and up to her head; Eyes swollen; hands hurt; sharp pings up and down legs; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 16Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included ongoing diabetic and previously took the flu shot one time and started having right arm pain across her chest over to the left side right after getting it. So she don't take it anymore and takes a bunch of herbs. The patient's concomitant medications were not reported. The patient reported that she has a disease, amyloidosis on an unspecified date, where there is a build up of protein in the body. She didn't know that there is protein in the shot and doesn't know the affects it has with her condition. She found out the day after getting the first Pfizer C-19 (clarified as COVID-19) shot that there was protein in it. The patient wanted to know the affects it has with her condition and if it will affect her getting the second dose and if it covers the new virus and booster shot. The patient got the vaccine on 16Jan2021 and found out about the protein in it the next day when it came across her phone. The patient received it at a school, where they vaccinated 1,169 residents. They text her to inform her she could get the vaccine. They also have the health department there. No other vaccines given that day or 4 weeks prior. On an unspecified date in Jan2021, the patient took 1 Tylenol about 15:00 that afternoon and seated herself in the chair about 17:45, then she felt a sweep over her stomach up her body and up to her head. She stood up and walked around to see if she was going to faint and she did not faint. She walked through the house and nothing else happened. The patient mentioned that her eyes have been swollen and her hands hurt, that's where the protein build up comes in the body. Has pings up and down her legs, they are sharp pings that lasted through on to Tuesday. She took 1 Advil to help and as of yesterday (as reported) no pings. Her hands still hurt, because this condition forms chains in the body and the chains are around the hands like carpel tunnel. The protein normally should leave the body and with this condition it doesn't and it leaves chains. When she was diagnosed with it they took a spot off the ankle to test it, the Dermatologist did and sent it off. No further details provided. Wants to know the affects of her getting the second shot. No further details provided. The outcome of the events amyloidosis and hands hurt was not recovered, the events felt a sweep over her stomach up her body and up to her head and sharp pings up and down legs was recovering, and the event eyes swollen was unknown.
80 2021-02-07 pain in extremity 1st Vaccine 1/15/2021; 2nd Vaccine 2/5/2021; seen in ED 2/8/2021 for fever, chills, and left arm pai... Read more
1st Vaccine 1/15/2021; 2nd Vaccine 2/5/2021; seen in ED 2/8/2021 for fever, chills, and left arm pain onset x 2 days.
80 2021-02-07 throat numbness mild numbness on her throat; This is a spontaneous report from a contactable consumer (patient). Thi... Read more
mild numbness on her throat; This is a spontaneous report from a contactable consumer (patient). This 80-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3426) at single dose on 08Jan2021 via an unknown route at left arm for Covid-19 immunization, which was recommended for her age. Medical history included ongoing cervical spinal stenosis for 5 or more years (no investigation assessment, no relevant tests), high cholesterol, high blood pressure, heart beat. Concomitant drugs included ongoing amlodipine besilate 5 mg twice daily for high blood pressure, ongoing atorvastatin 10mg daily for high cholesterol, ongoing hydrochlorothiazide 12.5 mg daily for high blood pressure, ongoing losartan 10 mg daily for blood pressure, ongoing metoprolol tartrate 25 mg twice daily for heart beat. Patient had been taking atorvastatin, hydrochlorothiazide, amlodipine besilate for a long time. Patient had been taking losartan for 10-11 years. Patient had been taking metoprolol tartrate for 4-5 years. No history of all previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations within 4 weeks. She experienced having mild numbness on her throat on 08Jan2021 that lasted for an hour and a half. The event clinical course was as follows: After waiting 15 minutes she was ok and was cleared to go. On the way to her car she felt numbness in her throat. It was mild and lasted for an hour and a half and then it cleared on its own. No Emergency Room or Physician Office visit required due to the event. She was scheduled to get the 2nd dose of the COVID-19 vaccine on 29Jan2021. She wanted recommendations on whether she should take the second dose of the vaccine. She was concerned if that would be a problem with getting the second shot. She was asking if this could happen again. Outcome of the event was resolved on 08Jan2021.
80 2021-02-08 weakness severe body aches starting evening of vaccine (dose #1), along with worsening weakness. Vaccine give... Read more
severe body aches starting evening of vaccine (dose #1), along with worsening weakness. Vaccine given 1/26/2021. Pt with ED visit for body aches 2/8/21 (high ESR > 100). Then admitted for observation 2/9/21
80 2021-02-09 weakness extreme diahrea weakness anto diahrea med dicyclomine still have diaerhea
80 2021-02-09 weakness I was like and off balance; I was tired and I wasn't quite myself, I wasn't myself; I was just feeli... Read more
I was like and off balance; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; Little bit light headed /The way I was laying down I got more dizzy; This is a spontaneous report from a contactable consumer (patient) An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 20Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included blood pressure problems and Blood sugar abnormal (a little bit of blood sugar). Concomitant medications included metoprolol tartrate for blood pressure management. On 22Jan2021 the patient experienced 'little bit light headed /the way I was laying down I got more dizzy' and 'was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish'. On an unspecified date the patient also complained 'I was like and off balance'. At the time of the reporting event outcome was unknown. Information on Lot/Batch number has been requested
80 2021-02-09 slurring After 2 weeks of received 1st dose COVID19 vaccine the patient presented to the hospital with a chie... Read more
After 2 weeks of received 1st dose COVID19 vaccine the patient presented to the hospital with a chief complaint of slurred speech, diffuse rash and headache. Found to have diffuse petechiae. Platelet count was < 2. CT head was significant for bifrontal and parafalcine subdural hematoma and scattered subarachnoid hemorrhage. Assessed by the hematology team who stated presentation and lab work was consistent with immune thrombocytopenia. Patient now admitted to the ICU undergoing platelet transfusions and treatment with steroids and IVIG
80 2021-02-09 flushing, burning sensation gray spot on forehead; face felt hot and flushed; Face red; was tired and wiped out; Eyes were red b... Read more
gray spot on forehead; face felt hot and flushed; Face red; was tired and wiped out; Eyes were red bloodshot; face was burning and burned bright red/her face feeling sunburned/ face got really like the worst sunburn; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot: EL8982) intramuscular in right arm on 22Jan2021 at 13:00 at single dose for COVID-19 immunization. Medical history included Gastroparesis from 2016 and ongoing, ongoing Osteoarthritis (diagnosed about 10 to 20 years before), acid reflux (esophageal), blood pressure, osteoporosis, arthritis, anxiety, high cholesterol, stomach problems, allergies and pretty bad sinus problems/sinus trouble in the winter, leg cramps at night, allergic to all kind of bites. Patient previously took shingles vaccine as immunization and she had had a small reaction, she had a patch of shingles break out around her arm at the site of injection site. Concomitant medication included ongoing omeprazole for Gastroparesis, ongoing erythromycin, ongoing aluminum hydroxide/magnesium carbonate (GAVISCON) for acid reflux (esophageal), ongoing calcium for Osteoporosis, ongoing losartan for Blood pressure, ongoing acetaminophen for arthritis, ongoing spironolactone as diuretic, ongoing tramadol for Osteoarthritis, vitamin C [ascorbic acid] as general supplementation, ongoing alprazolam for Anxiety, ongoing doxazosin for high blood pressure, ongoing fenofibrate for High cholesterol, ongoing vitamin b complex (B-COMPLEX) as general supplementation, ongoing bisoprolol for high blood pressure, ongoing magnesium good for heart recommended by cardiologist, ongoing biotin for hair and nails, ongoing zinc as immunity booster, ongoing montelukast sodium for allergies and pretty bad sinus problems/sinus trouble in the winter, ongoing levocetirizine dihydrochloride (XYZAL) for allergies, ongoing cyclobenzaprine for leg cramps at night as muscle relaxer, ongoing macrogol 3350 (MIRALAX) as laxative and ongoing "CVS brand multivitamin at one tablet once a day oral as general supplementation" (as reported).The patient experienced face felt hot and flushed and face red on 24Jan2021; gray spot on forehead on 25Jan2021; was tired and wiped out, eyes were red bloodshot, face was burning and burned bright red face feeling sunburned in Jan2021.Events were described as follows: patient received the first dose of the vaccine on 22Jan2021 and she had a few mild symptoms. She did not feel really good for a day or two but it was nothing that alarmed her, she was tired and wiped out. She always took a shower since she had arthritis and it get gets her joints going. On 24Jan2021 after she got out of the shower, her face felt hot and it was red. She didn't think too much about it and it went away pretty soon. She did not connect it with the vaccine. On 25Jan2021 she took a little longer shower and the same thing happened, but it was 10 or 12 times worse in regards to her face feeling hot and was red. She was drying off and getting dressed and reported her face felt funny and it was really hot. When she looked at it was bright red like she had the worst sunburn, it felt like a sunburn. Her face was red and eyes were red bloodshot and it lasted about half an hour; her face got real flushed like a real bright sunburn and her face was burning and burned bright red. She started putting on cold wet wash cloths to help cool her face down and when it the wash cloths got warm, she would wet it again to cool her face down some more. She was alarmed but about 30 minutes later it started lightening up a bit and pretty soon it was back to normal. Her face felt different in the afternoon, it was a little red. She worked out in yard and last summer she got an insect bite on her forehead that turned gray, it was the size of silver dollar. After the hot flush thing this morning, that gray spot came back. Her doctor said it might take a while for it to go away. Her face felt warm like it has been sunburned. Her throat was dry since she has been waiting on the phone for an hour. Her face feeling sunburned/hot was about 95% gone, barely there. Her face getting red started on 24Jan2021 morning and it was almost gone. Treatment included ponds face cream and it was very soothing. Patient just wanted to know what to do about this flushing of her face and if it was dangerous what she can do. She would like to know if she should be worried about this, it only happened when she took a shower. She was asking if there was anything she can do before she can get the second injection, so it does not happen again or what to do if it does happen again. Final outcome of tired and wiped out, eyes were red bloodshot and face was burning and burned bright red/her face feeling sunburned/ face got really like the worst sunburn was unknown; outcome of the other events was not recovered.
80 2021-02-09 muscle twitching, grand mal seizure, myelitis transverse, involuntary muscle movements The night after receiving dose 1 of the vaccine, she didn't want to eat dinner, was starting to spit... Read more
The night after receiving dose 1 of the vaccine, she didn't want to eat dinner, was starting to spit up saliva, and noted a new headache, and asked her daughter to sleep with her that night considering she was feeling poorly. She was restless all night, and then at ~5am her L arm began to twitch; she was still alert at this time but didn't realize her arm was moving. Shortly after this she lost consciousness, her eyes rolled back in her head, and she developed a frank GTC seizure. Her daughter called an ambulance, and by the time she was on the way to the hospital, she was awake and alert again. At the hospital, she was initially talking and able to answer most questions appropriately. She was noted to be afebrile, hemodynamically stable, without an O2 requirement, though with tachycardia to the 110s. She was found to have a leukocytosis to ~16, thrombocytosis to ~550, and LDH elevated in the 600s. Over the following day, her mental status declined and she became agitated and disoriented to place/time. CT chest revealed b/l multifocal pneumonia, for which she was started on pip-tazo. She underwent MRI brain (DWI sequence only) which did not reveal any obvious CVA. LP was performed on 1/29 at ~10PM; as far as we can tell, she had only received pip-tazo for antibiotics at this point. CSF studies revealed 220 WBCs (14% PMNs, 76% lymphs, 10% monos), 14 RBCs, Glu 59, Prot 145; GS 2+ WBCs, no orgs; india ink stain negative; Cx pending at time of transfer. Given concern for bacterial or viral meningoencephalitis she was transitioned to vancomycin/ceftriaxone/acyclovir. Patient was then transferred to another Hospital for further management. Micro was all negative or pending at the time of transfer. Shortly after admission to hospital she was intubated. Spine MRI was notable for longitudinally extensive transverse myelitis. All infectious workup has been negative with just two more pending studies for tuberculosis; autoantibody panel pending. She is now able to follow commands with eyes and mouth, but has not been able to move her arms or legs. We do not have high suspicion that this syndrome is related to the vaccine, given that progressive neurological symptoms started the week before vaccine, but thought it prudent to report given the time course.
80 2021-02-11 pain in extremity Pt rec'd vaccine two days ago and was sick a day later, light fever, chills, joints hurt, headache,... Read more
Pt rec'd vaccine two days ago and was sick a day later, light fever, chills, joints hurt, headache, having a hard time raising the arm, it's very sore, nauseated, lasted 1 day.
80 2021-02-15 flushing Patient was vaccinated at 1435 pm and immediately upon vaccination patient noted hives going up her... Read more
Patient was vaccinated at 1435 pm and immediately upon vaccination patient noted hives going up her left forearm. This was the same arm of the vaccination. 50mg of Benadryl was administered orally at 1440 pm per our policy and procedures and patient continued to be monitored for adverse signs and symptoms. At 1505 RN noticed flushed face and redness on neck. No shortness of breath was noted and speech was maintained. At 311 patient stated general feeling of racing heart. Vitals were taken. HR 80, BP 140/80, RR 14. EMT was notified and called with a 1526 Arrival. Patient was transferred to Healthcare and call back at 1629 letting us know patient was stable.
80 2021-02-16 cold sweat This person received the 1st dose COVID-19 vaccine Pfizer @ 08:13am. Then @0930 am, c/o "feeling ... Read more
This person received the 1st dose COVID-19 vaccine Pfizer @ 08:13am. Then @0930 am, c/o "feeling something on top of her chest, heaviness of chest", sweaty hands, clammy, chest pain. Rapid Response Team called at 09:35 am. Transferred to Emergency Room. In ED: Diagnosis included but not limited to STEMI, NSTEMI, unstable angina, anxiety. At 10:04am- based on EKG, code STEMI was called. Consultation with cardiologist. Then the patient was sent emergently to Cath Lab. The patient was admitted to ICU, intensive care, following Cath Lab
80 2021-02-17 tingling 80 y/o F presents for tingling sensation to B/L hands and high blood pressure after receiving the 2n... Read more
80 y/o F presents for tingling sensation to B/L hands and high blood pressure after receiving the 2nd dose of the Covid-19. Patient was taken to the ED for monitoring; she denied any allergic reaction, CP, fever, chills, lightheadedness, dizziness, N/V/D/C, abdominal pain or other symptoms aside from tingling of all fingers. Her blood pressure was 197/92 at the time. EKG was performed, which was normal. No medications were administered. After 2 hours, the blood pressure normalized to 140/80 and patient was discharged.
80 2021-02-18 seizure Confusion, Admitted to Hospital on 2/12/21 Noted to have siezures
80 2021-02-21 pain in extremity I am reporting that I was diagnosed with shingles after 2 wks of getting my 1st dose of Covid vacci... Read more
I am reporting that I was diagnosed with shingles after 2 wks of getting my 1st dose of Covid vaccine shot in my upper left arm. My arm starting hurting & a few days later, I broke out with tiny dark red spots inside a red swollen circle. Arm remained with a burning aching pain. My dermatologist said it was definately shingles & prescribed a 10 day treatment of antiviral medication. She didn't know if it was caused by the vaccine but should report this. The shingles are just below the shot area.
80 2021-02-21 pain in extremity injection site inflamation redness around injection about the size of a quarter, itchy with raised ... Read more
injection site inflamation redness around injection about the size of a quarter, itchy with raised bumps, tin taste in mouth, irrated tongue. severe tiredness. sore arm.
80 2021-02-22 difficulty speaking Asthma attack began about 20 minutes after injection, with throat tightening, slight mouth swelling ... Read more
Asthma attack began about 20 minutes after injection, with throat tightening, slight mouth swelling sensation and immediate wheezing which grew progressively worse. I had my inhalers (Levalbuterol and Flovent) with me, used Levalbuterol at the direction of medical people who surrounded me after I reported wheezing. They gave me a Benadryl, then brought a wheel chair and sent me directly to the ER. I was there about 3 hours during which I had a heart monitor, a "breathing treatment" by a respiratory therapist, and DUONEB, famotidine (PEPCID), and (DELTASONE). I was given a 3 day Rx for 20 mg. of prednisone, and released. My lungs felt "twitchy" the next day and my voice was muted, but was well otherwise. The only "normal" side effect I had was some soreness at the injection site for a couple of days, with some light sensitivity there for a few weeks.
80 2021-02-23 facial paralysis, mild one side paralysis Pfizer-BioNTech COVID-19 Vaccine EUA: five days after vaccination patient presented to emergency dep... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: five days after vaccination patient presented to emergency department with left-sided facial droop, right gaze preference, and left hemi-paresis. Patient diagnosed with right middle cerebral artery occlusion, likely thrombotic etiology, admitted to hospital, and underwent thrombectomy and recanalization with symptom improvement. Discharged to home improved, stable, with vital signs within normal ranges two days after arrival to emergency department.
80 2021-02-23 pain in extremity pt states that she had a left arm and mild body aches for a couple of days after getting the covid v... Read more
pt states that she had a left arm and mild body aches for a couple of days after getting the covid vax. Three or four days later she started getting dizzy and nauseated. She says she feels hungry even after she eats. Pt states the dizziness comes and goes and is normally in the morning. She doesn't feel right and feels unsafe when she walks like she may fall. Pt contacted her PCP on 2/23/2021 and they just told her to see if the symptoms went away and the FU if they did not.
80 2021-02-25 weakness Lightheaded; Weakness; Nauseated; Vomiting; did not have an appetite; This is a spontaneous report f... Read more
Lightheaded; Weakness; Nauseated; Vomiting; did not have an appetite; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. Medical history included stroke 14 years ago. Concomitant medication included warfarin. The patient was lightheaded, did not have an appetite and experienced weakness on Jan2021. She was even nauseated and threw up earlier on Jan2021. She wanted to know what can she do. She had nauseousness and vomiting. She vomited one time but she was not currently vomiting and just took some Ginger ale to settle her stomach. Patient was asking what to drink or does she take any Tylenol or let it. Outcome of the events was unknown. The date of second dose was 16Feb2021 Information about batch/lot number has been requested.
80 2021-02-25 pain in extremity Systemic: Joint Pain-Mild, Additional Details: Patient was being observed, at the 15 minute mark the... Read more
Systemic: Joint Pain-Mild, Additional Details: Patient was being observed, at the 15 minute mark the pharmacist asked how the patient was doing and to see if she had any issues or comments or concerns after the injection, she complained of pain and soreness in her leg but this was from previously diagnosed arthritis and it happens when she sits for long. She had no further questions and felt healthy to go.
80 2021-02-25 pain in extremity Systemic: Joint Pain-Mild, Additional Details: At the end of the 15 minute observation time after th... Read more
Systemic: Joint Pain-Mild, Additional Details: At the end of the 15 minute observation time after the patients COVID shot, she complained of leg soreness from her preivously diagnosed arthrtitis. She did not have any further questions or comments or concerns about the injection and did not think the soreness was from the shot. She felt healthy to go.
80 2021-02-26 weakness Weak; lightheaded; cotton mouth; difficulty breathing; HA. Evaluated by EMS-cleared.
80 2021-02-28 pain in extremity, tenderness Patient had her second COVID vaccine on 2/20/21. The next day she developed diffuse body aches. Sh... Read more
Patient had her second COVID vaccine on 2/20/21. The next day she developed diffuse body aches. She went on to develop worsening dyspnea and fever to 103°F on February 23. She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed. She therefore presented to the ER on 2/25/21. See full history below from infectious disease note on 3/1/21: Patient is an 80 year old female who has a past medical history notable for hypertension, dyslipidemia, and hypothyroidism. The patient was diagnosed with a high-grade lymphoma of the retroperitoneum in 2004 and completed 4 cycles of multi-chemotherapy (Cytoxan, Adriamycin, vincristine, methotrexate, and IT chemotherapy (Magrath-like regimen)). She completed 4 cycles with complete remission on PET scan. The biopsy of a left cervical lymph node in 2007 revealed follicular lymphoma and she completed radiation therapy to the neck with complete remission. A left axillary lymph node biopsy in 2016 revealed grade-3 follicular lymphoma with mixed follicular and diffuse histology. Chemotherapy was pursued. The biopsy of a pelvic lymph node in 2019 was consistent with G1-2 follicular lymphoma.  She completed radiation to the pelvis in May of 2019.  She developed progressive pelvic adenopathy in April of 2020 and received 5 cycles of chemotherapy. Subsequent CT showed improvement in the adenopathy.  Her course was complicated by pulmonary emboli (September 2020).  In November of 2020 she was started on maintenance Rituxan every 2 months.  She received the 2-dose Pfizer COVID vaccine series on 1/29/21 and 2/20/21. With the above background, the patient presented to the emergency room on February 25, 2021 with complaints of diffuse body aches, which had developed that day after receiving her second dose of COVID-19 (SARS-CoV-2) vaccine.  She went on to develop worsening dyspnea and fever to 103°F on February 23.  She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed.  She called Oncology on February 20 and it was recommended that she go to the emergency room for evaluation.   She was afebrile on presentation to the emergency room.  She was tachycardic, however, with a pulse rate of 117 bpm.  She was breathing at 48 breaths per minute.  Blood pressure was 105/80 mmHg.  Oxygen saturation by pulse oximetry was 96%. Examination was notable for paraspinous muscle tenderness, tachypnea, mild respiratory distress, and a mildly distended abdomen.  Mild erythematous patches of the feet and forearm were noted, as well as evidence of edema of the right leg from the knee to the lower leg. The peripheral blood leukocyte count measured 0.8x10e3/µL.  ANC was 0.48x10e3/µL.  Platelets measured 96x10e3/µL.  Creatinine was 0.97 mg/dL.  AST was 86 and ALT 20 U/L. The lactic acid level of the venous blood was 3.6 mmol/L. The procalcitonin level of the blood measured 28.37 ng/mL. The C-reactive protein level was 313.7 mg/deciliter. The creatine kinase (CK) level was 4023 U/L.  LDH measured 314 U/L. Troponin was 3.22 ng/mL.  Urinalysis showed 6-10 wbc?s, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, hyaline and granular casts as well as amorphus crystals. A chest radiograph showed possible, but not definite, mild atelectasis or infiltrate at the left lung base.  A radiograph of the right tibia/fibula showed circumferential soft tissue edema seen within the knee and upper to mid aspect of the lower leg.  EKG showed sinus tachycardia but no evidence of arrhythmia or ischemia. Cultures of specimens of the blood were obtained.  The patient was started empirically on vancomycin and cefepime and was admitted.   Faint erythema and ecchymosis of the right leg extending to the dorsal right foot and right wrist erythema were noted following the patient?s admission.  Her condition subsequently destabilized with increased respiratory rate, worsening pain, and hypotension, so she was transferred to the ICU. An abdominopelvic CT on February 25 revealed a small amount of free fluid in the abdomen around the liver, cholelithiasis with no evidence of acute cholecystitis or biliary dilatation, a nonobstructing 5-mm stone of the mid pole of the left kidney, coronary artery calcifications, mild infiltration of the fat in the inferior retroperitoneum and along the right common iliac region with small nodes in this region, similar compared with September 24, 2020, but improved compared with April 30, 2020, and consistent with response of lymphoma to chemotherapy; a myomatous uterus. A CT scan of the right lower extremity showed extensive edema about the subcutaneous tissues of the right lower leg and infiltration of the fat about the muscles of the right lower leg, likely representing cellulitis and fasciitis, and possible myositis. However, there was no air within the subcutaneous tissues or muscles to suggest necrotizing fasciitis and no evidence of abscess.     The patient?s antibiotic treatment was later changed to vancomycin, piperacillin-tazobactam and clindamycin. Cultures of specimens of the blood were later reported as being positive for methicillin-susceptible Staphylococcus aureus on 2/2 sets. Repeat blood cultures (February 26) were positive as well. Her antibiotics were modified to cefazolin monotherapy. Repeat blood cultures on Feb 27 and 28 were negative.   TTE completed 2/27/21 without obvious vegetation.   TODAY (3/1/21): Cultures negative 2/27 and 2/28. Remains on IVIG. Afebrile. She complaints of continued pain in the Right leg and swelling at that left arm. Exam GENERAL: NAD EYES: Sclera and conjunctiva clear NECK: no adenopathy LUNGS: Breath sounds normal and symmetric. No rales or wheezes. HEART: regular rhythm, no murmur appreciated ABDOMEN: Soft without mass, tenderness, organomegaly or hernia. EXTREMITIES: RLE with ecchymosis, slight overlying erythema and anterior blister: blistering more pronounced today. left foot with plantar erythema, some tenderness today. LUE fullness with some heat/tenderness SKIN: No other rashes or other abnormalities are noted. NEUROLOGICAL: alert, appropriate Assessment 1. MSSA septicemia with shock. Positive blood cultures 2/25 and 2/26 thus far. Negative since 2/27. 2. Multifocal cellulitis and interstitial infective myositis of LE- suspect related to above. CT scan was negative for apparent necrotizing infection. 3. Elevated CK due to above- improving 4. Recurrent lymphoma- has been on maintenance rituximab (11/2020). Immunocompromised state. 5. Low immunoglobulins- remains on IVIG 6. Positive urine cultures with Staph aureus- this is typically secondary seeding from bacteremia rather than primary staph uti. CT abd/pelvis negative for nidus of infection along GU track (no renal abscess for example) 7. LUE swelling/tenderness.   Plan 1. Cont Cefazolin without change: goal dosing 8gm/24hr 2. Following repeat blood cultures, negative thus far (tentative D0= 2/27/21) 3. Pending course, anticipate likely TEE--- > presently precluded due to thrombocytopenia 4. Will obtained LUE doppler for completeness given pain/swelling here. Down the line, may need to consider additional imaging (CT?) if concern for abscess, etc). 5. ID will follow along with you. Please call if any questions/concerns. Patient is still admitted, and is in the ICU.
80 2021-02-28 pain in extremity fever, arm pain
80 2021-02-28 tingling The mix of vaccine, dental anesthesia and Amoxicillin caused an enduring flu-like symptoms and tingl... Read more
The mix of vaccine, dental anesthesia and Amoxicillin caused an enduring flu-like symptoms and tingling/pressure on left side of head where tooth was treated.
80 2021-03-01 feeling hot Pt received vaccine and waited appropriate post-vaccination observation period. Pt exited COVID Vacc... Read more
Pt received vaccine and waited appropriate post-vaccination observation period. Pt exited COVID Vaccine Clinic. Returned to clinic at 1535 and c/o of warm sensation in body. Vital signs checked: 209/79, HR 79; Recheck: 201/84, HR 74 Emergency Response team called to transport Pt for evaluation of symptomatic hypertension Pt transported to Emergency Department
80 2021-03-02 weakness Had shallow breathing; Very weak; Could not walk; Disoriented; Wanted to sleep; Incoherent; couldn't... Read more
Had shallow breathing; Very weak; Could not walk; Disoriented; Wanted to sleep; Incoherent; couldn't/wouldn't eat; Dehydrated; This is a spontaneous report from two contactable consumers (primary reporter was patient's husband). An 80-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included ended up in the hospital for 2 weeks with pneumonia and COVID-19 at the end of last Summer. The patient's concomitant medications were not reported. The patient's husband reported that the patient received the first Covid shot about a week to two weeks ago. She went to the facility and got the shot and was fine afterwards until she came home. Later that afternoon, she started showing symptoms of problems, was weak and couldn't walk, disoriented, wanted to sleep, was incoherent, couldn't/wouldn't eat, was very, very much having trouble, shallow breathing. He tried to stay right her and eventually it got to be scary for him with her shallow breathing. He ended up calling an ambulance and she went to the hospital. They gave her tests and was there until about 4 or 5 in the morning before she started showing signs. She was dehydrated was a part of it. The tests were showing the symptoms were improving and she was beginning to come out of it fortunately with doctor's care because he didn't know what to do. He had been going through materials and she is coming up on another shot next Monday and does not want her to go through that if it can be helped. She was coming up for the second shot. Saw something on the tv that rattled him to his bones. It had been found that people who had Covid virus previously and then got the shot may not need a second shot. He is trying to flush that out to whether or not that is something or not that she should be considering. They have the card to go back to the same place for the second shot and they are trying to figure if they need to set up an appointment now. Hoping that this was the worse of it and it is hard for them to call back and his physician is not an expert on this and he got Pfizer's office contact number and decided to call. Outcome of the events was recovering. Information on the batch/ lot number has been requested.
80 2021-03-02 weakness Chills; Fever; aches and pains; no appetite; felt weak as a kitten; injection site got swollen; havi... Read more
Chills; Fever; aches and pains; no appetite; felt weak as a kitten; injection site got swollen; having pain where the injection occurred; she had felt like she was at death's door; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose on BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN6200) solution for injection, via an unspecified route of administration in right arm on 15Feb2021 at a single dose for Covid-19 immunization. Medical history included allergies, hip surgery, and foot surgery three times. Concomitant medications included unspecified medications. Patient reported she has been so sick. She got the shot on Monday 15Feb2021, and that same day she got so sick, it was horrible. Patient had chills, fever, aches and pains, and if someone named it, it was there. She stated that before Monday she was 183 pounds, didn't know if it has changed as she has not been on a scale, but she was sure it has because hasn't eaten since Monday, as she has had no appetite. Her appointment was at 07:45, and she went right when she got up, so she did not really have anything to eat on Monday. Patient stated that on Tuesday, she did not eat anything until the evening when she had one piece of pizza. Today, patient has only had a yogurt. Today was the first time she has gotten out of bed and even felt like getting dressed and putting her contacts in, since Monday. The last few days, patient stated that after getting up and going to the bathroom she would walk downstairs and felt weak as a kitten (15Jan2021). Patient stated that she was at least 80% better, because she had felt like she was at death's door (Feb2021), and she was not a wimp, it was just horrible. Patient mentioned that she was on a lot of medicine, probably 10, but this was the first time she was receiving this vaccine. She stated that she was still having pain where the injection occurred (Feb2021), like when her shirt touches it, she can tell it was there. But patient stated that she had the nicest nurse and the injection itself did not hurt, it was just later, and the injection site got swollen (Feb2021). Outcome of the event she had felt like she was at death's door, chills, fever, aches and pains, felt weak as a kitten was recovering; no appetite was not recovered; while the other events was unknown. No follow-up activities are needed. No further information is expected.
80 2021-03-02 pain in extremity 38 hours after vaccine was given, patient awoke to a heart attack...says it felt like someone punche... Read more
38 hours after vaccine was given, patient awoke to a heart attack...says it felt like someone punched her between the shoulder blades and kept their fist there, pain then radiated down both arms to the elbows - more substantial on the rt side, pain also radiated up to the back of her jaw.
80 2021-03-02 tremor red blotches; felt sensation at her foot for that she could not walk; experienced chills; hands were... Read more
red blotches; felt sensation at her foot for that she could not walk; experienced chills; hands were shaking; right foot and ankle swelling; right foot and ankle swelling; pain; This is a spontaneous report from a contactable consumer (reporting for herself). An 80-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date: 31May2021), via an unspecified route of administration on her left arm on 30Jan2021 to 30Jan2021 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took phenytoin sodium (DILANTIN) and carbamazepine (TEGRETOL) and experienced allergy as her reaction to those were sometime between 2010 and 2012. On 30Jan2021 after three and a half hours, the patient felt sensation at her foot for that she could not walk, experienced chills, hands were shaking, had a swollen ankle and foot and pain. Around 5 o clock, the patient stated that it was like a strange sensation in her foot and she also got chills. By 7 o clock, she was in pain. The patient stated that she took two Tylenol. The patient stated that at around 9 o clock, she noticed that her ankle and foot were swollen with red blotches on it so she took two Benadryl and then slept until noon. The patient stated that Benadryl actually gave her some relief, although the pain didn't completely subside, but it subsided a little so that it was more tolerable. The patient stated that she had been debating if she should have gone to the emergency room (ER), but she didn't because she has a high pain tolerance. The outcome of the events was unknown.
80 2021-03-03 numbness and pain in extremities, pain in extremity hand felt like it was sleeping especially her finger tips it felt like neuropathy; Joint pain; Exhau... Read more
hand felt like it was sleeping especially her finger tips it felt like neuropathy; Joint pain; Exhaustion; same arm that she broke, it seemed weaker now which it seemed like the side effects go to areas that were weakened before; with the arm the pain and movement in that arm has worsened since the injection; with the arm the pain and movement in that arm has worsened since the injection; with the arm the pain and movement in that arm has worsened since the injection; with the arm the pain and movement in that arm has worsened since the injection; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9266 and expiry date 31May2021, via unspecified route of administration on 15Feb2021 at single dose for Covid-19 immunization. Medical history included, broke her elbow from 04Dec2020 and surgery from 12Dec2019 and second surgery was from 15Jul2020; the patient thought that the second surgery on her arm was in 2020 and she actually broke her arm in 2019. She thinks it was actually Dec2019 when she broke her arm and the second surgery was on 15Jul2020; ongoing with the arm the pain and movement in that arm (movement disorder) and arm; weakened (same arm that she broke). There were no concomitant medications. The patient was taking the same medications she always takes, and she waited until after the dose to take them. Historical vaccine included first dose of BNT162B2 lot number EL02162, expiry date 31May2021 for Covid-19 immunization. The patient was calling about the vaccine, the second Pfizer COVID 19 vaccine. She experienced some side effects, there was joint pain on 15Feb202 later that nigh and the most obvious thing was exhaustion that began later the same day as well; but one thing was unusual, the strange side effect that has happened on 16Feb2021 was that her hand felt like it was sleeping especially her finger tips it felt like neuropathy but it was much better now, it was the same arm that she broke, it seemed weaker now which it seemed like the side effects go to areas that were weakened before. The patient stated that the main thing was the neuropathy thing, it felt like she was sitting on her hand and that persisted, but it was 90 percent better and she thinks it will go away. The neuropathy feeling was ongoing but much less, it was improved it happens only if she squeezes her hand so it was much less and she hoped it just dissipates. The patient's main concern was the neuropathy and it has improved a great deal. The patient mentioned with the arm the pain and movement in that arm has worsened since the injection (Feb2021). The worsened pain and movement has persisted about the same since she noticed it. The patient informed that was the joint she guessed, because she broke the elbow. The outcome of the events hand felt like it was sleeping especially her finger tips it felt like neuropathy, joint pain, exhaustion was recovering, same arm that she broke, it seemed weaker now which it seemed like the side effects go to areas that were weakened before was unknown, while not recovered for the rest of the events.
80 2021-03-03 tingling Tingling in ankles, lightheadedness, "heat" in the back of the throat. Pt was observed for an hour a... Read more
Tingling in ankles, lightheadedness, "heat" in the back of the throat. Pt was observed for an hour and felt better. Dr. stated she can leave, no additional care needed besides observation. BP 131/44, O2 98, Pulse 71. Pt reports similar reaction to 1st dose.
80 2021-03-04 inability to speak 3/3/21 er to hospital admission: 81 y.o. female with a history of Parkinson's in previous stroke. ... Read more
3/3/21 er to hospital admission: 81 y.o. female with a history of Parkinson's in previous stroke. The patient basically is maintained in the nursing home in this state of being bed-bound and nonverbal. She was recently transferred to Rehab after she developed a stage IV sacral ulcer at a previous nursing home. The patient had been seeing wound care and doing very well. Her stage IV sacral ulcer had been healed to a stage II. She had been gaining weight. Unfortunately, at her wound care appointment yesterday the wound had decompensated a little bit and had started to drain some purulent material. It also enlarged in size a little bit. I was called yesterday afternoon and the nursing home reported the patient was not wanting to eat or drink. Lab work showed a sodium of 170 and creatinine consistent with acute kidney injury. She also appeared to have a urinary tract infection. Because of her critical labs she was sent to the nursing home. The patient was evaluated in the nursing home and then admitted to the floor. She was given Zosyn and vancomycin and started on IV fluids. The emergency room physician did counsel the family that the prognosis was very grim. The patient has done reasonably well overnight. She has been grimacing quite a bit and the family has decided they just want her kept comfortable comfort care during admission
80 2021-03-05 hot flush Pt. in observation was feeling dizzy and hot flash. Paramedics assessed pt. once symptoms subsided ... Read more
Pt. in observation was feeling dizzy and hot flash. Paramedics assessed pt. once symptoms subsided and vitals were cleared pt. was released to leave. (tent 11).
80 2021-03-05 pain in extremity Second dose adverse events: Extremely horrid headache, chills and low grade fever, fatigue, sore ar... Read more
Second dose adverse events: Extremely horrid headache, chills and low grade fever, fatigue, sore arm. Slept almost all day and all night of the second day. Second dose-second day: Headache almost gone but very sore eyes, the arm was better, fatigue lingers, and noticeably breathless. Later but don't remember exact day; Rt jaw bone by the ear sore; hard to open my mouth to eat. This side had the Bells Palsy in 1996.
80 2021-03-07 involuntary muscle movements Thumping in ears; swelling in face; straight mouth unable to move; This is a spontaneous report from... Read more
Thumping in ears; swelling in face; straight mouth unable to move; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. The patient has no medical history. Concomitant medication included acetylsalicylic acid (ASPIRIN BAYER) and vitamin D [vitamin D nos]. The patient experienced thumping in ears while in observation room and had swelling in face with a straight mouth unable to move on 30Jan2021 23:30. Outcome of events was unknown. The adverse events resulted in emergency room/department or urgent care. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.
80 2021-03-07 flushing 1st shot about 20 minuets later started felling flushed and temp fluctuated for about two hours. Th... Read more
1st shot about 20 minuets later started felling flushed and temp fluctuated for about two hours. Then a day or two later started getting left arm rash then on to the right arm a few days later. Don't know if rash was caused by that. Went for 2nd shot today and rejected when I told them about fluctuation of temperatures at fist shot. How can I get second shot??
80 2021-03-07 pain in extremity On 2/17/2021 (2nd dose)about 4 p.m. started feeling nauseous and dizzy-injection arm became very so... Read more
On 2/17/2021 (2nd dose)about 4 p.m. started feeling nauseous and dizzy-injection arm became very sore. The next 2 days t he same as late afternoon on the day of injection. 2/20/2021 woke up feeling fine. 2/21, 2/22 back to feeling nauseous and dizzy with the injection arm hurting a lot. 2/22, 2,24, 2/25 were fairly good days. But 2/26 woke up at 3:30 a.m. feeling very, very nauseous and then vomiting violently and again at 6:30a.m. and 8:30a.m. (along with a bad case of diarrhea. Was nauseous for the next 3 days and could not move my left arm above my elbow.
80 2021-03-08 numbness, tingling Numbness and tingling of lower face, as occurs when a herpes lesion is going to break out. V3 distr... Read more
Numbness and tingling of lower face, as occurs when a herpes lesion is going to break out. V3 distribution, no motor loss. Started 2 days after second covid innoculation. Occassionally gets better, but recurs again after a short period of time. I had polio and had some facial nerves involvement; am also a physician, retired now.
80 2021-03-09 pain in extremity white count was low; Left arm got a red rash all the way up and down, my shoulder to mid way betwee... Read more
white count was low; Left arm got a red rash all the way up and down, my shoulder to mid way between my elbow and hand and some swelling; Left arm got a red rash all the way up and down, my shoulder to mid way between my elbow and hand and some swelling; my arm hurt a little bit; This is a spontaneous report from a contactable nurse (patient). An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1284) on left arm, intramuscular on 02Feb2021 at single dose for COVID-19 immunization. Medical history included pancreatic cancer stage IV metastasized, blood pressure (abnormal) and chemo. Concomitant medication included pancreatin (CREON) for pancreatic enzymes. The patient previously received the first dose of BNT162B2 on 12Jan2021 for COVID-19 immunization. The patient had a side effect and it's so weird, she was a cancer patient she was in (city, state) and she had her first Covid vaccine on 12Jan2021 and she had her second one on 02Feb2021 and not a reaction until yesterday (06Feb2021) her left arm got a red rash, all the way up and down her shoulder to mid way between her elbow and hand and some swelling and she just wanted to make sure. She did look at the sheet and it does say you can get a rash, she has no temperature and she wanted to make sure that's a part of it all. When clarified if the retired registered nurse wanted to if it was the side effects from Covid vaccine, she stated, she guessed so because she got it on Tuesday and her arm hurt a little bit (Feb2021) but no rash showed up until yesterday which was Saturday. The patient had blood work done last Monday on 01Feb2021 with unknown results. The patient reported that she knows her white count was low (unspecified date) because they could give her chemo, so she actually has blood work on Monday 01Feb2021. Treatment was not received and patient stated, it just showed up yesterday and her nurse told her not to put anything on it. The outcome of the events was unknown.
80 2021-03-10 muscle spasms Noticed small, scattered bruises inside left thigh; they went away with time. After second vaccine ... Read more
Noticed small, scattered bruises inside left thigh; they went away with time. After second vaccine 3/1 I began to have leg cramps at night, after 1 week still tired and sore.
80 2021-03-10 tremor On the 5th day after receiving the vaccine I became dizzy. The next morning I became very dizzy and... Read more
On the 5th day after receiving the vaccine I became dizzy. The next morning I became very dizzy and went to the hospital. They admitted me to Emergency because my blood pressure was extremely high-they said later it was about 187/ ?. While I was there the blood pressure went up over 200 to 214/81. I was dizzy and nausious and shaking because I became very cold even though the nurse covered me with 3 blankets. After I left the hospital it took until after I got a prescription for meclizine filled and took one at 7PM before I was able to get the blood pressure down to a normal range - 130/64. Today I am still taking meclizine as prescribed and am still slightly dizzy. I do not know if this was related to the vaccine or not.
80 2021-03-12 pain in extremity 7"30 p.m. on day of vaccination (2-26-21) my arm where I got the shot (left) began to hurt. Today i... Read more
7"30 p.m. on day of vaccination (2-26-21) my arm where I got the shot (left) began to hurt. Today is March 13th the arm still hurts not just at the injection site but the pain throbs throughout the arm and it is hard to carry/pick up items. It's not life threatening but I don't understand why it is still hurting Also I wonder if when I get my second vaccine next Friday, March 19, 2021, if I should get it in my right arm.
80 2021-03-14 pain in extremity, muscle spasms Nausea, severe headache, pain in left leg, mouth has copper taste, cramping on the third day after v... Read more
Nausea, severe headache, pain in left leg, mouth has copper taste, cramping on the third day after vaccine. Never reached out for treatment.
80 2021-03-14 pain in extremity sore right arm; This is a spontaneous report from a Pfizer-sponsored program. Contactable consumers ... Read more
sore right arm; This is a spontaneous report from a Pfizer-sponsored program. Contactable consumers (including the patient) reported that an 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK4176, expiration date: Mar2021) intramuscular on the right arm on 21Jan2021 14:00 at 0.3 mL, single for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. She had the first shot. She was going for the second shot on Thursday. She had a sore right arm on Jan2021, so she took ibuprofen (ADVIL) and she was hoping she did not ruin the fact that she had the first shot. The Advil took the soreness away and she has not had any problems since. The soreness started late in the evening when she went to bed around 11:30 or 12 and that was when she took Advil. The sore arm recovered the next day. She heard rumors from people that people should not take Advil or Tylenol after receiving the shot. She asks if this was true. She is asking if she can take Advil for her second dose. The events did not require a visit to physician office or Emergency Room. The facility where the vaccine was administered was in a convention center. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event was recovered on an unspecified date in Jan2021.
80 2021-03-15 burning sensation Very large black and blue mark at site of injection. Burning on occasion
80 2021-03-18 discomfort choking experience; throat tickled; dizziness; bowel movements all afternoon which is a common aller... Read more
choking experience; throat tickled; dizziness; bowel movements all afternoon which is a common allergic reaction; bowel movements all afternoon which is a common allergic reaction; Her heart started to pound/a rapid heartbeat; her ears started to ring (a pounding in her ears); had pressure in her jaw, chest, head, ears, and allover; high adrenal stimulance; excreted 1 cup of urine more than what she usually does; high pressure; dehydrated; couldn't sleep; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 01Mar2021 13:30 (at 80 years old) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome, allergic to gluten, lecithin, and other barky parts of plants, high pressure, she did not hear very well, left breast surgery, skin cancer. She had a small skin cancer taken off each of her legs, one removed in Jan2020 and one removed in Feb2020. They are all healed up and they are fine, it was not the bad kind. There were no concomitant medications. The patient experienced choking experience in which her throat tickled, and dizziness, dehydrated, her heart started to pound (a rapid heartbeat), her ears started to ring (a pounding in her ears), she had pressure in her jaw, chest, head, ears, and allover, she had high pressure, excreted 1 cup of urine more than what she usually does, couldn't sleep due to high adrenal stimulance, bowel movements all afternoon which is a common allergic reaction all on 01Mar2021 with outcome of unknown. Clinical course was reported as follows. She mentioned that she was fine for 20-30 minutes to an hour after she got home. That afternoon, she noticed that her bowel movement was regular, constant, and repeating which was not normal and would typically indicate SIBO (Small intestine bowel overflow) in which the colon empties everything. She mentioned that this was indicative of her gluten allergy. She reported having had bowel movements all afternoon which is a common allergic reaction she has to plants like lectin and gluten especially due to the irritable bowel system-her whole bowel system will empty and she will have to replace 2 days worth of food. With this event starting 01Mar2021 her bowels just kept emptying and emptying. During dinner while she was eating and watching tv, her heart started to pound (a rapid heartbeat), her ears started to ring (a pounding in her ears), she had pressure in her jaw, chest, head, ears, and allover, she had high pressure, and a choking episode in which her throat tickled, and dizziness that she couldn't get up. She took hot water for the tickling sensation and took one aspirin for the other symptoms, but she still did not feel very well. She went to bed at 9pm but couldn't sleep due to high adrenal stimulance, she only slept like 2-3 hours long which she can get from Novocaine with her teeth. She got up 3 times and excreted a cup of urine per time. In the morning, she woke up and excreted 1 cup of urine more than what she usually does. She got herself weighed and had a weight of 109lbs versus the normal 122lbs which indicated that she was really dehydrated so she took her fluids and ate breakfast. Other than this, she mentioned that she got up today and felt fine and feels that in 2 days she will be fine. She felt pretty good and she was going to run but did not dare burn any more calories or fluids so she is sitting still and taking it easy. Regarding outcome of event she reported the pounding pressure like high blood pressure are better, fine# she had a normal breakfast# she can get around and do whatever she needs around the house except she needs now to spend the day recouping from the dehydration so she needs pay attention to what she eats and drinks. She mentions that she runs 3-4 miles a day and tries to be active for her age. She is asking if she can take the 2nd dose in 3 weeks. She is unsure if this is an allergic reaction or something psychological. The outcome of the event was reported as recovering.
80 2021-03-18 myelitis transverse, mild one side paralysis Pt BIBA with sx of stroke, including right sided weakness and numbness. imaging suggestive of transv... Read more
Pt BIBA with sx of stroke, including right sided weakness and numbness. imaging suggestive of transverse myelitis vs. spinal cord infarct
80 2021-03-18 pain in extremity 4 days after injection where shot was given it hurt deep. In the morning it was itchy, inflamed and... Read more
4 days after injection where shot was given it hurt deep. In the morning it was itchy, inflamed and hurt. deep pain in areas down to fingers.. enflamed area has increased still with itching and deep pain along the arm and fingers.
80 2021-03-21 bell's palsy Left Bells Palsy
80 2021-03-21 pain in extremity While sitting, patient felt a severe pain on L side of head about 8.5 hours after injection. Then th... Read more
While sitting, patient felt a severe pain on L side of head about 8.5 hours after injection. Then the L foot started throbbing and pt wasn't able to move L foot. Pain traveled from L foot up to the L thigh. Next R entire leg started out with a grabbing, throbbing spastic unbearable pain that lasted for about 30 minutes. Predominant pain was on the R thigh and continued to seize up and caused incredible pain, every bit of a 10 on the pain chart. Pt took salt and 1000 mg acetaminophen. Pt states that if she hadn't been sitting she would've gone down and not been able to walk or move
80 2021-03-23 pain in extremity pain at injection site, patient states she flinched due to the extreme pain in left arm x 2 weeks. I... Read more
pain at injection site, patient states she flinched due to the extreme pain in left arm x 2 weeks. In addition, pain in both hands x 2weeks. Has taken Tylenol with no relief. Referred to primary provider
80 2021-03-23 tremor Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat T... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Medium, Systemic: Shakiness-Medium, Additional Details: Patient reported allergy to flu vaccine, asked for reaction and she did not report anaphylactic symptoms. Patient told that we will watch over her after receiving the vaccine. About 5 minutes later, swelling on back of the neck reported and gave Benadryl 25mg. Later reported difficulty swallowing and administered 1 dose of 0.3mg epinephrine. Daughter called 911, after arrival patient reported feeling better but still taken to ER. Daughter said she felt better at ER.
80 2021-03-24 pain in extremity Right arm soreness/pain extending from a couple of inches below injection site to a couple of inche... Read more
Right arm soreness/pain extending from a couple of inches below injection site to a couple of inches above the elbow on the outer part of arm; client used heat and Tylenol
80 2021-03-24 pain in extremity sore left arm started several weeks later around 15Mar2021
80 2021-03-24 tremor Patient incident report Pt: Allergies: Penicillin 14:45 client claims to feel new onset trembling in... Read more
Patient incident report Pt: Allergies: Penicillin 14:45 client claims to feel new onset trembling in her legs bilaterally feel trembly with her second dose of the covid Pfizer vaccine Lot ER8732 Ex: 07/2021, denies feeling any reaction with her first dose, nursing staff was altered-------------------------------------------------------------------------------- 14:52 she has history of high blood pressure and diabetes type II, she denies any chest pain, denies shortness of breath, denies trouble breathing, denies itching, denies rash, vitals taken blood pressure 190/85, pulse 97, SPO2 97% , pain scale 0/10, A & O x4 to person, place, DOB, and situation.---------------- 14:55 client was given a simple sugar and protein to eat14:59 reassessed client?s vitals BP- 199/88, Pulse 94, denies pain 0/10, denies shortness of breath, denies trouble breathing, denies chest pain, denies itching, denies rash, client claims she still feels the trembling in her legs-------------------------------------------------------------------------------------- 15:03Emergency services was called, stood by patient while she was in the car to monitor, client claimed to feel an improvement of the trembling, denies chest pain, denies shortness of breath, denies trouble of breathing denies rash, denies itching------------------------------------------------------------ 15:15Emergency Services arrived to the site started to provide treatment to the client, client claims to feel better still has trembling in the bilaterally legs15:23 blood sugar was taken by the emergency service team reported 138-15:31 client was being transported to Hospital
80 2021-03-30 weakness she experienced Diarrhea; she had muscle weakness in both legs and back; legs felt weak; This is a s... Read more
she experienced Diarrhea; she had muscle weakness in both legs and back; legs felt weak; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 05Feb2021 13:40 (Batch/Lot Number: EM9810) as single dose for covid-19 immunisation. Medical history included Diabetes from Mar1964, she does some exercise after the shower for the hip surgery done prior to the vaccine. Concomitant medication included insulin lispro (HUMALOG) uses with a pump taken for diabetes mellitus. Caller stated she received her first dose of the Pfizer covid vaccine on Friday, and yesterday morning 09Feb2021 she experienced Diarrhea and then later on she had muscle weakness in both legs and back. She does some exercise after the shower for the hip surgery done prior to the vaccine and uses a cane to walk. She said she is a little better today and wanted to know if that was due to the vaccine. Outcome of the event she had muscle weakness in both legs and back was unknown. Outcome of the other events was recovered on 10Feb2021.
80 2021-04-01 feeling hot, pain in extremity Sore arm, headache and redness (particularly left beast) itching and felling as though my skin is h... Read more
Sore arm, headache and redness (particularly left beast) itching and felling as though my skin is hot. Mostly upper body.
80 2021-04-02 muscle spasms spasms, pain in torso area, has effected my urine and bowel movements.
80 2021-04-07 pain in extremity, feeling hot high blood pressure; cholesterol; flutter; her hands were red and felt warm; heart pains; she wakes ... Read more
high blood pressure; cholesterol; flutter; her hands were red and felt warm; heart pains; she wakes up groggy; pain in middle of her chest; she felt tired/she feels worse; her arm hurt; her hands were red and felt warm; her legs felt heavy; This is a spontaneous report received from a contactable consumer, the patient. A 79-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 04Mar2021 at 17:15 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included blood cholesterol increased from 2011 and ongoing; diagnosed 10 years ago, hypertension from 1991 and ongoing; diagnosed 30 years ago, chest pain from an unknown date and unknown if ongoing. Concomitant medications included atenolol taken for blood pressure from an unspecified start date and ongoing; benazepril hydrochloride, hydrochlorothiazide taken for blood pressure from an unspecified start date and ongoing; nifedipine taken for blood pressure from an unspecified start date and ongoing; simvastatin taken for blood cholesterol increased from an unspecified start date and ongoing. The patient experienced she was having issues with her heart/she also has pain in middle of her chest like heart pains/seems like more pressure and sort of constant, her hands were red and felt warm, high blood pressure, cholesterol, flutter, her legs felt heavy on 04Mar2021, she felt tired/she feels worse on 06Mar2021, she wakes up groggy, her arm hurt on 04Mar2021, she was having issues with her heart/she also has pain in middle of her chest like heart pains/seems like more pressure and sort of constant. Her hands were red and felt warm, had high blood pressure, cholesterol, flutter, her legs felt heavy, she felt tired/she feels worse, she wakes up groggy, and her arm hurt. She states that she could hardly sleep on the left side, so she is going to have it on the right next. The chest pains started a few weeks ago and it started before the vaccine but now it seems like more pressure and sort of constant, not a pain, pain but a pressure that she knows is there. Now and then she feels a flutter. Clinical outcome of heart pain was not recovered, for hands were red and felt warm, high blood pressure, cholesterol, flutter, she felt tired, she wakes up groggy, pain in middle of her chest was unknown, her legs felt heavy, her arm hurt was recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
80 2021-04-08 pain in extremity Shoulder/arm pain. Started hurting March 14. Still hurts.
80 2021-04-08 pain in extremity rash and pain on the toes bilateral feet
80 2021-04-10 muscle spasms, tremor Severe cramps and diarrhea 2 days after 2nd shot. Sweaty, lightheaded and achy with shaking chills,... Read more
Severe cramps and diarrhea 2 days after 2nd shot. Sweaty, lightheaded and achy with shaking chills, but no fever.
80 2021-04-12 pain in extremity Knot has developed on arm where the vaccine was administered - the arm has become swollen and the ... Read more
Knot has developed on arm where the vaccine was administered - the arm has become swollen and the pain is increasing and not decreasing pain.
80 2021-04-18 pain in extremity Blood in left leg. Hospitalized for 3 days. Now on Eliquist. Couldn't walk on left leg. Had to pul... Read more
Blood in left leg. Hospitalized for 3 days. Now on Eliquist. Couldn't walk on left leg. Had to pull the cord and maintenance called the ambulance. Still having pain in left leg even after a cortisone shot still not better and they don't know why. Next appoint is on Thursday. There is another appoint at the pain clinic for her back pain tomorrow
80 2021-04-24 burning sensation shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; shingles rash bu... Read more
shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; shingles rash burning, itching, and pain; Chills; Fatigue; Shingles; This is a spontaneous report from a contactable consumer.A 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Feb2021 14:30 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included Mitral valve prolapse, thyroid surgery, sleep apnoea. The patient's concomitant medications were not reported. On February 26th she got her first dose of the vaccine, and she is scheduled to get the second April 8th. She says on March 8th she was diagnosed with shingles. Her shingles rash she really didn't have long, it has almost faded now, it is almost nothing as far as scabs. She says she still has the burning, itching, and pain, but today it is not so bad. She says she sometimes has chills, which is one of the things that goes along with it, and fatigue. She says her concern was about this too, because even though the rash is gone she still has symptoms, does this mean her shingles are still active. She says she asked her pharmacist and they said it could still be active. her first dose of the vaccine was given in the afternoon, probably 02:30PM. She says she was diagnoses with shingles on March 8th after a visual diagnosis. Pfizer COVID-19 vaccine NDC/EXP: Not provided on handwritten vaccine card. AE Treatment: Caller says for the shingles her doctor hasn't said anything, she did get a prescription which she took, of 3 tablets a day for a week, so 21 tablets. She says she was also prescribed an ointment that she was putting on. She says that the tablets were Valacyclovir 1 gram, and she took one tablet by mouth three times daily for 7 days. She says this medication was dispensed in a pharmacy bottle from pharmacy, NDC/LOT/EXP were not provided on pharmacy label. Caller says the ointment was Triamcinolone Acetonide ointment USP 0.025%, which was applied usually before bed around 10:00PM-10:30PM. She says the label on that says apply externally to affected area twice daily for 15 days, but she applied it only once a day. Caller says that the EXP on the tube is little, it is July 2022, LOT: Unknown, unable to see on the tube. NDC: Caller says this is very, very little, she needs her magnifying glass, it looks like it is 45802-054-35. She says that the NDC is almost not on there, it is so little. Outcome of shingles, rash,burning, itching, and pain was recovering, of chills and fatigue was unknown.Therapeutic measures were taken as a result of shingles. No follow-up attempts possible. No further information expected.
80 2021-04-25 bell's palsy, facial paralysis *PLEASE NOTE: The second Pfizer dose was received on 1/29/2021, could only enter one date on the pre... Read more
*PLEASE NOTE: The second Pfizer dose was received on 1/29/2021, could only enter one date on the previous form.* Patient awoke with profound paralysis and drooping on right side of face. Could not close right eye. No pain, numbness, or tingling. Patient contacted a doctor approximately 36 hours after onset of symptoms. Diagnosis of Bell's palsy via video examination and interview. Will visit local physician tomorrow (4/27).
80 2021-04-27 discomfort The caller reports that approximately one week after her second COVID19 Pfizer vaccine, she experien... Read more
The caller reports that approximately one week after her second COVID19 Pfizer vaccine, she experienced swelling of her left axillary lymph node with related discomfort and pain. She reports the symptoms resolved in about 1-1.5 weeks without further complication.
80 2021-04-29 pain in extremity sore arm, rash
80 2021-04-29 pain in extremity sore arms, body aches
80 2021-04-30 seizure, muscle twitching arteries in my head on that side is narrowing, were narrowed.; seizure; it felt like somebody hit me... Read more
arteries in my head on that side is narrowing, were narrowed.; seizure; it felt like somebody hit me on the head; I am sleeping a lot; violent headache; my body jerked; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8733), via an unspecified route of administration on 06Apr2021 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Consumer stated, "What happened when I came home exactly at 1:50, I had it exactly at 5:15. I thought somebody shot me in the head. I had the TV remote in my hand, and it felt like somebody hit me on the head and remote went flying across the room and on to the floor. That was the first time and a half hour later it happened again I had a teaspoon in my hand at the dinner table, my body jerked and that went across the room than it happened two more times. I had nothing in my hand. But I jerked in my body, body jerked and a violent headache for 6 days now. I have had MRI of the head and I have to see if my neurologist, but he cannot see me till the 30Apr2021." Lab work: Consumer stated, "I went and had the MRI." When asked for any other help, consumer stated, "No, but I still don't know. I still have to go to my neurologist and my artery doctor because they said my arteries in my head on that side is narrowing, were narrowed. So, I am in for a long holiday. I had to go to a lot of doctors to figure out what they are going to do, and I am sleeping a lot, there is something wrong. I just want Pfizer to know just something not right with that. If you want also my husband but he came with me and he had shot with me. He had headache for five days but nothing else just the headache for 5 days from the same LOT." On 21Apr2021, information due to 2nd shot of Pfizer was again reported. She had a reaction 4 hours after that shot, kind of like a seizure, she had a TV remote in my hand and out of nowhere it when flying out of my hand across the table and onto the floor, this result happened 4 times within two hours that same day. Have had headache for 16 days since. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown result on an unspecified date. The outcome of the events was unknown.
80 2021-05-02 pain in extremity She got the vaccine, had no reaction at all. Then on Saturday morning she noticed that there was a ... Read more
She got the vaccine, had no reaction at all. Then on Saturday morning she noticed that there was a red circle light pink circle on her upper arm, about in the area of the injection. Then over the next few days it got hot to touch, and the redness slowly started to spread. Right now it has spread down to the inside of her upper left arm, and is very itchy. She looked for a bug bite but has not seen one. She called her pharmacist yesterday and he suggested that this often happens with this particular reaction to that vaccine and told her to take Benadryl and to put cortisone cream on that area, but the area is still hot to touch, red, itchy and hurting.
80 2021-05-03 pain in extremity I had an allergic reaction to the Pfizer Covid vaccine; I fell; Passed Out Without Warning and Hit h... Read more
I had an allergic reaction to the Pfizer Covid vaccine; I fell; Passed Out Without Warning and Hit her Face on the Tile Floor; Busted Mouth; Stitches in Mouth; Right Knee Very Sore /Left Shoulder Very Sore and Can't Use It; Black Left Eye; states it was black, blue, purple, green and yellow; Tiredness; Left Hand Pinky Sore; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 11Mar2021 14:00 at age of 80-year-old (Batch/lot Number: EN6205) at single dose for COVID-19 immunization. The vaccine was not administered at Military Facility. Medical history included she has hearing aides but it is hard to hear or understand sometimes. There were no concomitant medications. Prior Vaccinations (within 4 weeks) was the first dose of Pfizer COVID Vaccine (Batch/lot number: EL9267) on 18Feb2021 at age of 80-year-old administered in right arm and no adverse events following prior vaccinations. The patient reported she had an allergic reaction to the Pfizer COVID vaccine, she fell on 11Mar2021, not fainted. On 11Mar2021, the patient passed out without warning and hit her face on the tile floor, experienced busted mouth/stitches in mouth, right knee and left shoulder were very sore, black left eye/it was black, blue, purple, green and yellow, tiredness, left hand pinky sore. The patient was calling about the Pfizer COVID Second Shot; verified Pfizer COVID Vaccine. Her second shot was on 11Mar2021 and on the same day she passed out without any warning whatsoever, and she hit the tile floor and ended up in the hospital for five days. She passed out and didn't remember falling or feeling anything before falling. The patient also has a primary physician, but she had been seeing the plastic surgeon for this. The patient asked what does she do if she needs to get a booster. It scared her to death if she would have to take another shot. The patient asked (name) to hand her a pair of glasses to read the plastic surgeons name. She stated the printing is so small on there. She was supposed to see the doctor on 19Apr2021, but she didn't feel good enough to go see the doctor. For busted Mouth, they put in 3 layers of stitches. The stiches have been giving her a fit because sometimes they come undone and hang down. She had to go back into him and get them cut out twice, and she had another one from last night (18Apr2021). It is very sore. States the stiches inside the lip have not resolved and it was still hard. One part of her lip is soft and one part is hard. It was all hard in the beginning. The stitches on the inside are supposed to dissolve. For right Knee it was very sore and she can't hardly use it. For left shoulder it is very sore and she can't hardly use it. It made it awkward to get in and out of bed when she can't use her left arm or her right knee. Her left shoulder was really bothering her and she may have to go have some more work done. It has been popping and went in and out of the joint. That would be back with her primary doctor. Sore pinky on left hand had recovered it didn't stay that long. Black left eye, it was black and blue purple green and yellow. It cleared up in the last couple of days. She was lucky she didn't break the bone around her eye. Treatment included stitches, hospitalization, given antibiotics and blood clotting shots so she didn't get blood clots, she had 3 of those in her belly. She wasn't allowed to get out of the bed when she was in the hospital. She had a terrible experience in the hospital. For the event onset time, it was at 20:00, they drove home from (place name), which is an hour and something, and they stopped at (place name), came home and set outside and she said she had to go lay down because she was tired. She woke up an hour and half to 2 hours later, got out of bed, sat on side, stood up and got herself together and walked to bottom of bed and went out flat. The events required a visit to emergency room and physician office. For emergency room visit, it was reported on 11Mar2021 at (hospital name); the patient should've called redacted number but didn't, they drove in. The patient was hospitalized from 11Mar2021 to 16Mar2021 at (hospital name). The outcome of passed out, tiredness were resolved on 11Mar2021, outcome of 'black left eye/it was black, blue, purple, green and yellow' was resolved on 17Apr2021, outcome of left hand pinky sore was resolved in 2021, the outcome of fell, allergic reaction to the Pfizer COVID vaccine were unknow, outcome of busted mouth, right knee/left shoulder very sore were not resolved.
80 2021-05-09 weakness, electric shock sensation I got my first shot on 1/5/2021. I had no adverse effects from the first shot. Three weeks later I... Read more
I got my first shot on 1/5/2021. I had no adverse effects from the first shot. Three weeks later I got my second shot on 1/26/2021. Three days after that, on 1/29/2021, I became quite ill. I had sudden onset of total body weakness, I was unable to sleep for 4 days, I developed a constant frontal headache, I felt like my body was electrified, my eyes started twitching and feeling like my eyelids were being pulled, my face felt like it was being pulled on one side, my nose became runny and hasn't stopped. To this day I have no energy and am not like my old self before the shot. I have gone downhill incredibly fast. My doctors don't know what to do with me and I don't think things are going to get better. My day to day life is a struggle. I have no energy to do things. One of the only things I have not had is a fever. My eye doctor told me he thinks I had a GROSS IMMUNE SYSTEM REACTION to the vaccine. 0 I would appreciate it if there is anything you can do to help me. Thank you,
80 2021-05-09 bell's palsy, facial paralysis patient experienced partial paralysis of face, left face. was taken to the hospital, ruled out a st... Read more
patient experienced partial paralysis of face, left face. was taken to the hospital, ruled out a stroke.. diagnosed bell's palsy
80 2021-05-09 slow speech The morning after Mom's first dose of the Pfizer shot, Dad woke up and found Mom lying on the floor ... Read more
The morning after Mom's first dose of the Pfizer shot, Dad woke up and found Mom lying on the floor next to the bed. Mom said, "I can't move my arm." Dad called paramedics who checked her. They said her vital signs were normal and left. On 2/9/21 in the morning my da awoke to see that Mom had large amounts of bubbly saliva pouring from her mouth onto her pillow. Dad called paramedics, who said this was a diabetic reaction. Mom had NEVER had anything happen like this before. Mom was very sleepy, could not be aroused, and made only gurgling noises. She was admitted to the hospital for care and therapy. She pulled her own IV out. Mom had to be restrained in the hospital and sedated, due to confusion and worsening dementia. By 2/18 when we spoke by phone mom's speech was abnormally slow and very repetitive. "I'm very tired today" was spoken many times. In morning time mom was able to follow basic conversation. Not so later in the day. Mom came home from rehab on 2/26/21. She was able to walk steadily and independently at home after her therapy. After a week or so, Mom began hitting the in-home caregiver. Dad's presence would calm her. In a short time Mom seemed not to know dad anymore, and would hit him and the caregiver when they helped her. She also pulled all covers off the bed and pulled clothes out of the closet, throwing them all over the room during the night. Mom was usually walking around the house during each night. On 4/16/21 Mom and dad were napping sitting up on the couch in the morning. Mom fell forward and hit her head on the hearth. Dad and caregiver gave first aid and called paramedics, who took her to the ER. Mom came home on 4/17/21. On 4/18/21 Mom pulled her catheter out in the early morning. In the afternoon Mom's appearance was concerning, so Dad called paramedics. They said that Mom's BP had dropped very low and took her to the ER. Mom was combative the next day in the hospital. Dr. adjusted her medications periodically to ensure that mom's care would be manageable when she would eventually be sent home. Minimal therapy was done due to dementia. By 5/3/21 doctor said that Mom is bed bound and needing total care. Her blood sugar spiked high despite special diet. Staff waiting for insulin order from doctor. 5/4/21 Doctor called Dad to say that Mom had died during the night.
80 2021-05-10 numbness, tingling, cold extremities hands are tingly; My hands are tingly and so cold.; felt terrible everyday; Nauseated; Arms felt lik... Read more
hands are tingly; My hands are tingly and so cold.; felt terrible everyday; Nauseated; Arms felt like they were asleep; so sick; Hurt all over; not moving too fast; I do not want food; I have not eaten, taken a shower or anything; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 09Feb2021 09:45 (at the age of 80-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included immunodeficiency, atrial fibrillation. The patient got her shot last Tuesday morning at 9:45 and had been real sick after this. The patient had a bad reaction to it. Well after patient got the shot it was in the. And it said if she was on blood thinner (Unspecified Medications) or 'immune disorder' (not clarified further) she know and she was both of those and was just wondering what to expect and today from elbow. On unspecified date of Feb2021 , her arms felt like they were asleep and then now it was from elbow bit down and her hands got real cold. Now she had not ran a fever and she had not vomited, but she did not want food. She had hurt all over and she had been nauseated (on unspecified date of Feb2021) but not vomited. She had not eaten, taken a shower or anything, and she had been so sick (on unspecified date of Feb2021). Well let her see if she could see a pen that writes. She was not moving too fast (on unspecified date of Feb2021). She wanted to know if this was going to affect her blood, the thickness or the firmness. Since Tuesday, 09Feb2021, patient hands were tingly and so cold. The patient had felt terrible everyday. She had other relatives that got some aches and fatigue , but nothing like what she had. The patient was not currently not taking any immunosuppressant drugs. Patient was enquiring that was it ok to get her 2nd Pfizer vaccine vaccine dose in 4 weeks. The patient also enquiring about was it a problem, with getting the vaccine, if she take Blood thinners, she had atrial Fib and used to get a lot of blood clots. And was there any problem with being immunocompromised and getting the vaccine. Outcome of the events was unknown. Information on batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.
80 2021-05-10 pain in extremity One week after receipt developed pain at the injection site, followed by progression to her shoulder... Read more
One week after receipt developed pain at the injection site, followed by progression to her shoulder to her elbow and wrist, with edema distal to her mid elbow. She reports the second injection seemed less careful and the site was too high. She has normal strength and reports her baseline is very strong as she has played tennis for 40 years. The pain has continued to increase and went to community ER 14 APR 21. EKG, U/S were normal. She is trialed Tylenol and NSAID and they have helped. Symptoms mostly resolved on f/u 06 May 2021. She occasionally gets a small amount of burning pain in her deltoid, but it is not significant. She is otherwise well.
80 2021-05-11 pain in extremity shingles; rash on right inner thigh; leg was painful and tender to the touch; didn't sleep well; Thi... Read more
shingles; rash on right inner thigh; leg was painful and tender to the touch; didn't sleep well; This is a spontaneous report from a contactable consumer (reporting for herself) via the medical information team. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot Number: EN6203; Expiration Date: Jun2021) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included surgery in the fall for cervical disc and cholesterol. Concomitant medication included simvastatin taken for cholesterol, start and stop date were not reported. On 25Feb2021 (reported as "the next day"), the patient noticed on her inner right thigh it felt like a rash but there was nothing there, but it felt like there was. The leg was painful and tender to the touch. The patient also didn't sleep well and talked to someone on 27Feb2021 (reported as Saturday) and said it sounds like shingles to them. The patient talked to the doctor and they felt like it was shingles. The doctor put the patient on medication which has really helped a lot. The rash was not getting worse, it has just stayed a little better and the same. The doctor prescribed her prednisone and valacyclovir, 1mg three times a day. The rash seemed to get worse in the evening, it was painful all around her leg, she thought it was a blood clot, but then realized no because the pain was on the outside it doesn't feel like it was on the inside. The rash wasn't red, Friday late afternoon it started being raised. The pain in her leg was sensitive but not like it was. The patient has kept her leg covered, its impossible to do this because of where it was on her leg. The pain was worse Friday night, the patient was able to sleep Saturday night, it was still sensitive. The outcome of the event didn't sleep well was recovered on 27Feb2021 while the outcome of the other events were recovering.
80 2021-05-11 seizure CVA (cerebral vascular accident) Unspecified convulsions
80 2021-05-11 tenderness minor hallucinations; metallic taste; horrible smell that she experiences in which it makes her not ... Read more
minor hallucinations; metallic taste; horrible smell that she experiences in which it makes her not want to eat or drink; chills; joint pain; tissue tender; This is a spontaneous report from a contactable nurse (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in deltoid right on 12Feb2021 (at the age of 80-years-old) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 22Jan2021 for COVID-19 immunisation. The reporter stated that since then (having both doses of the vaccine), she has been to the emergency room 4 different times experiencing side effects. She has a metallic taste and horrible smell that she experienced in which it made her not want to eat or drink. She has minor hallucinations, chills, joint pain, and her tissue is tender. Her joint pain has improved. Then stated, "I'm afraid I'm going to die from it." She asked if anyone has reported these reactions previously and what should she do about them. Her family physician's nurse looked up a study in which 11% of the patients were experiencing a metallic taste. Also stated, "This is very discouraging and depressing." The outcome of the event joint pain was recovering while of the rest was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of minor hallucinations cannot be excluded due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
80 2021-05-12 bell's palsy Bells palsy, medication given, not sure of outcome
80 2021-05-13 weakness weakness diarrhea poor appetite fever chills shortness of breath
80 2021-05-14 pain in extremity pain all over body; Chest pain; Leg pain; severe pain on her neck, she couldn't lift her head; Monda... Read more
pain all over body; Chest pain; Leg pain; severe pain on her neck, she couldn't lift her head; Monday morning she couldn't get out of bed.; the red blood cell count was low; the hemoglobin was low; having to use a walker; anxiety; her heart starts racing; has been taking steroids and her weight has shot up like crazy now she is 120 lbs; The platelets which is the ones that do the clotting, normal high is 200 and hers were higher than normal at 760; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. An 80-year-old (currently she just turned 81-year-old) female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 03Feb2021 3:20 PM (Batch/Lot Number: EN5318) as single dose at the age of 80-year-old for covid-19 immunisation, as care provider for her husband, administered at a COVID vaccine clinic setup. Medical history, family medical history and concomitant medications were none. She has been very healthy. Before BNT162B2 first dose, In Jan2021, 2 weeks prior BNT162B2, she got the second dose of shingles shot (VARICELLA VACCINE) for immunization with no adverse effect. No adverse effect occurred following prior vaccinations. No other history of all previous immunization with BNT162B2. No additional vaccines administered on same date of BNT162B2. In Feb2021 she experienced pain all over body with outcome of recovered, chest pain with outcome of recovered, leg pain with outcome of recovered, severe pain on her neck. In 2021 the patient experienced the platelets which is the ones that do the clotting, normal high is 200 and hers were higher than normal at 760, she couldn't lift her head, Monday morning she couldn't get out of bed, the red blood cell count was low, the hemoglobin was low, having to use a walker, anxiety, her heart starts racing, has been taking steroids and her weight has shot up like crazy now she is 120 lbs. The patient underwent lab tests and procedures which included in 2021: haemoglobin: low, platelet count: 760 higher than normal at 760, red blood cell count: low , weight: 120lbs. Therapeutic measures were taken as a result of events. The course of events was as follows: After she got the first dose she had some adverse reactions in 2021: she had pain all over body, chest pain, leg pain, severe pain on her neck, that she couldn't lift her head. She has seen some specialists to seek assistance, she has seen a hematologist, and a rheumatologist. She has been on steroids and she was not yet done with the second dose of the Pfizer COVID 19 vaccine. Her doctor was very aware. When this started 3 months before, she 110 lbs but she has been taking steroids and her weight has shot up like crazy now she is 120 lbs, she told her doctor that she had no more fat clothes she will have to get off of the steroids, they blame everything on steroids. She said nothing else is relevant she was fine, in fact she was dancing the weekend before, that Saturday night she went to a Portuguese evening and was learning to do their dances and Monday morning she couldn't get out of bed. She refused to go to Emergency Room for the events. She has seen her doctor who requested she see a hematologist and a rheumatologist because she was having pain in her legs, she was having to use a walker. The hematologist found that her blood was out of whack. The platelets which was the ones that do the clotting, normal high is 200 and hers were higher than normal at 760, higher than what they call the high normal. The events pain all over body she had chest pain, leg pain, severe pain on her neck may have began a week after the vaccine in Feb2021. The pain was not ongoing, it was gone. They gave her massive doses of steroids she was taking 15 mg of steroids and right now they are lowering it. She had not the pain now but it was worse than childbirth. She has recovered completely from the pain, she felt fine now she has to wait until they take the steroids away again. She stated a lot of the blood, the red blood cell count was low, the hemoglobin was low, everything was low except for the platelets. So they told her to wait. She stated they blame everything on the steroids. Her anxiety started and her heart started racing, they said it was steroids, she was hungry they say it was steroids, she told the doctor she was gaining weight, they say it was steroids. No further information provided. She went to physician on 28Apr2021, the blood hematologist and they say it seemed that most blood work was back to almost normal everything was going down, the treatment she was receiving was working, the platelets were going down. She confirmed she had to wait to come off the steroids to get the second dose and she asked the doctor if she could get the second dose, she still wanted to get it but they told her she has to wait until she is completely off the steroids. The outcome of pain all over body, chest pain, leg pain, severe pain on her neck, she couldn't lift her head was recovered in 2021, of platelets which is the ones that do the clotting, normal high is 200 and hers were higher than normal at 760 was recovering, of she couldn't get out of bed, the red blood cell count was low, the hemoglobin was low, having to use a walker, anxiety, her heart starts racing, has been taking steroids and her weight has shot up like crazy now she is 120 lbs was unknown.
80 2021-05-15 mild one side paralysis Patient is an 80 y/o right handed female who is totally independent at baseline who received her Pfi... Read more
Patient is an 80 y/o right handed female who is totally independent at baseline who received her Pfizer vaccine out of the country (1st dose 2/19/21, 2nd dose 3/12/21). She was reactive to both shots, reporting arthralgias, headache, low grade fever, chills. She had a rise in blood pressure later during the day of her shot as well as the next day (up to 180/70, from baseline of 130/70). She also had an episode of epistaxis several days after her first shot. She traveled independently out of the country on 3/31/21 to visit her son on a leisure trip. On 4/5/21 she had headache, dizziness/lightheadedness, and did not feel well, and her systolic BP was 198, after which she took additional 40 mg of lisinopril. Her BP subsequently decreased to systolic BP of 130 mm Hg on 4/5/21, but over the next few days she had labile BP with a range of BP of 125 to 171/ 58 - 68. She was meticulous in checking and recording her BP several times a day, and she increased her lisinopril dose to 40 mg po qd from 20 mg po qd given the higher than usual blood pressure range. On 4/10/21 her BP was as follows: 6:30 am, 148/60 (she took her daily lisinopril 20 mg po); 11:30 am: 132/52; 3 pm: 171/69 (she took additional lisinopril 20 mg po) after which her systolic BP decreased to 130. Then around 6:20 pm the same day (4/10/21), she had acute onset of headache, vomiting, left sided weakness, SBP 220, and was witnessed to have rapid change in mental status. There was no antecedent trauma to the head. EMTs were called immediately and she had loss of consciousness during the ambulance ride to the ED, after about 20 minutes of symptom onset, with agonal breathing and bradycardia to the 40s, but never lost her pulse. Upon arrival to the ED out of the country, her Glascow Coma Scale (GCS) was 6, she was rapidly intubated and stabilized. Head CT demonstrated massive intraparenchymal hemorrhage (140 cc) within the R temporal parietal and occipital lobes, with cerebral edema and 14 mm midline shift, associated with small subdural hematoma and small intraventricular hemorrhage within the temporal horn and body of the R lateral ventricle. They reported hyperdense "spot sign" within the intraparenchymal hematoma compatible with active hemorrhage, no evidence of venous thrombosis, no masses, no arteriovenous malformations. She had 2.5 mm aneurysm right that was thought to be incidental finding unrelated to her event. She was taken emergently to the OR on 4/10/2021 for decompressive R hemicraniectomy, which she underwent successfully with minimal blood loss. She had no coagulopathy and her platelets and hemoglobin were normal. She remained in the Neuro ICU for 3 weeks. She received a tracheostomy two weeks after her presentation, and was weaned off the ventilator. She is breathing spontaneously after 5 weeks from presentation. She remains in coma or minimally conscious state, with GCS score of 5-6 as of 5/13/2021.
80 2021-05-18 pain in extremity Sweating , pain in legs fever
80 2021-05-19 numbness Stroke Sudden fall around 1:15 PM on May 6, 2021. Laceration on head and eyebrow as result of fall.... Read more
Stroke Sudden fall around 1:15 PM on May 6, 2021. Laceration on head and eyebrow as result of fall. Lightheaded after fall. Loss of feeling on left side. Dystonia of left hand. Arrived at ER around 2:30 PM. MRI Diagnosis: Cerebrovascular accident due to embolism of right middle cerebral artery (HCC) Transferred to Another hospital around 5:00 PM. Treated with blood thinners. ICU for about 24 hours Numerous CT scans and MRI, ECG Normal function of left side restored. Slight loss of sensation remains on left side. Discharged from hospital and returned home. 5/9/21
80 2021-05-25 weakness cut her left thumb right across the top with a cat food can lid; couldn't vacuum because she was so ... Read more
cut her left thumb right across the top with a cat food can lid; couldn't vacuum because she was so weak.; felt that she needed to lay down because she was so tired; felt like she had the full blown (COVID-19) Virus; regurgitating; nausea hit her like 'bang'; little bit of diarrhea; Weakness; felt deathly ill for a month; vomited up the Cephalexin 500mg; lost 25 lbs. in a month and a half.; very acute bronchitis that hit her after her first COVID-19 Vaccine; coughed and coughed for about 2-1/2 weeks; thought she had whooping cough; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 at 15:30 at the age of 80 years old (Batch/Lot Number: ER8727) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included uterine cancer (uterine cancer at 28 years old, had surgery for the uterine cancer); renal cancer (kidney cancer battled for 8-1/2 years. did not want another surgery, doctors did liquid cobalt treatments); nasal cavity cancer (had surgery to remove the cancer on nose about 7-8 years ago. had big hole taken out of her big Irish Cherokee nose. Thought the cancer was from her cat always hitting her with its claw on that side of her nose), bronchitis ( all her life) , radiotherapy (liquid cobalt treatments) , arthritis in back , kidney infection, pertussis, cytogenetic abnormality (missing half of a chromosome). Concomitant medication included estrogen nos (ESTROGEN NOS) 0.06 mg, 1x/day half of the pill in the morning, taking estrogen since she was 48 years old, meloxicam (MELOXICAM) 15 mg, 1x/day half of the pill at night for three years for arthritis in her back, cefalexin (CEPHALEXINE) taken for kidney infection, start and stop date were not reported. The patient previously took B12 shot every month (no additional information provided. No Additional Vaccines were Administered on Same Date of the Pfizer Suspect. No other vaccines were given within 4 weeks. The patient experienced felt like she had the full blown (COVID-19) Virus, regurgitating, nausea hit her like 'bang', little bit of diarrhea, Weakness, felt deathly ill for a month on 28Mar2021; lost 25 lbs. in a month and a half, very acute bronchitis that hit her after her first COVID-19 Vaccine, coughed and coughed for about 2-1/2 weeks, thought she had whooping cough, vomited up the Cephalexin 500mg on Mar2021; felt that she needed to lay down because she was so tired, couldn't vacuum because she was so weak on 09Mar2021, cut her left thumb right across the top with a cat food can lid on 10Mar2021 Treatment was given for cut on left thumb received 7 stitches in her left thumb on 10May2021 and bronchitis. Relevant Tests were reported as None. The clinical course was reported by the patient as follows patient received her first COVID-19 Vaccine dose on 28Mar2021 at about 3:30PM, and by 6:30PM, she felt like she had the full blown (COVID-19) virus. She stated started regurgitating. The nausea hit her like 'bang' and she had a little bit of diarrhea, and was really weak. She felt deathly ill for a month. Today (10May2021) was one of the first days she got dressed, and was up for the whole day. She said some days, she could not get up for more than an hour or two, and then she would have to go back to bed because she was so weak. Her doctor told her since the second COVID-19 Vaccine dose was supposed to be a little rougher than the first COVID-19 Vaccine dose, he didn't want her to get the second COVID-19 Vaccine dose. She said she was 80 years old, and had always been very self-sufficient. Stated she beat cancer 3 times. The patient called her physician, and her doctor wanted her to go to the hospital but didn't want to go. The doctor told her to take Cephalexin 500mg for 2-1/2 weeks, and then drop down to 1 Cephalexin 200mg nightly. Caller mentioned she kept Cephalexin 200mg and Cephalexin 500mg on hand in case she had symptoms of a kidney infection because she lived in a mountain town, and wasn't close to her doctors office. Since she had a history' kidney cancer she had more kidney infections'. Patient would take Cephalexin 500mg if she was hit hard with a kidney infection, and she would take Cephalexin 200mg is the kidney infection symptoms were just starting. Patient vomited up the Cephalexin 500mg. She said she lived on ginger ale and water. She stated she lost 25 lbs. in a month and a half. She said she was trying to gain back some of her weight now. No further details provided. Patient developed a very acute bronchitis that hit her after her first COVID-19 Vaccine. She clarified she coughed and coughed for about 2-1/2 weeks. She said she thought she had whooping cough, and had no way to stop the coughing. She could not vacuum because she was so weak. She said she went outside yesterday, and was outside for 20 minutes. She said she felt so weak, she went inside and laid down on her couch. She said she fell asleep for 4 hours. She said her weakness was like nothing she ever experienced before. Felt energetic and would start to do something, and then felt that she needed to lay down because she was so tired. She said she would go lay down, and then wake up 4 hours later. She doesn't think she was positive for the COVID-19 Virus. No further details provided. Patient stated she cut her (left) thumb (right across the top with a cat food can lid) this morning. She said the clinic in the valley, put 7 stitches in her left thumb today. The clinical outcome of the events Regurgitating, Nausea, Diarrhea, Vomited recovered; weakness, Ill feeling, Acute bronchitis, cough was recovering, while the remaining events was unknown. Follow up attempts are needed. Further information has been requested.
80 2021-05-25 difficulty speaking chills/terrible chills; throat raspy was with a dry mouth; throat raspy was with a dry mouth; headac... Read more
chills/terrible chills; throat raspy was with a dry mouth; throat raspy was with a dry mouth; headache; "red puffed up" fingers/her finger tips got red and she had swollen red hands; "red puffed up" fingers; muscles hurting; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer via a medical information team. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EL1283; Expiration Date: 30Apr2021), via an unspecified route of administration, administered in Arm Left on 22Jan2021 10:00 as SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer survive (diagnosed in 2008), Allergies: latex, Allergies: sulfa. There were no concomitant medications. The patient previously took ciprofloxacin [CIPRO] and experienced Allergies, influenza vaccine (FLU VACCINE VII) (flu shot) for immunization and experienced no adverse event. The patient experienced headache on 22Jan2021 10:10, "red puffed up" fingers/her finger tips got red and she had swollen red hands on 22Jan2021 10:10, "red puffed up" fingers on 22Jan2021 10:10, chills/terrible chills on 22Jan2021 11:00, throat raspy was with a dry mouth on 22Jan2021 10:20, muscles hurting on 22Jan2021. It was reported on the COVID vaccine that the patient got the first shot on 22Jan2021 and was sent an email that her second dose was scheduled for 05Feb2021, was that ok. It was also noted when she got the first vaccine they held her up at the location because she has allergies. After getting the shot, her finger tips got red, her throat got raspy, and she got a headache. When she got home she had terrible chills and her muscles hurt. It was clarified that her finger tips got red and she had swollen red hands- this started 10 minutes after the injection was given and continued on and off for about a week. Throat raspy was with a dry mouth- this started 20 minutes after getting the shot and lasted about a week and a half. Headache - this started 10 minutes after getting the shot and lasted 3-4 days. Terrible chills- this started about an hour after getting the shot and lasted about 5 hours. Muscles hurting- this started that day and lasted 2 days. She reports she went to the emergency room 2 days later on 24Jan2021 and was given an antihistamine and told to take 2 Benadryl before the second shot. Since she was told she had an allergic reaction to the vaccine she was nervous about getting the second shot, what should she do. The outcome of the events headache, "red puffed up" fingers/her finger tips got red and she had swollen red hands, "red puffed up" fingers, throat raspy was with a dry mouth and allergic reaction to the vaccine was recovered on an unspecified date in 2021 and the events chills/terrible chills was recovered on 22Jan2021 16:00, muscles hurting was recovered on 24Jan2021. Follow-up attempts are completed. No further information is expected.
80 2021-05-26 hot flush feeling like I was going to pass out; Left side of left wrist turned very red, while in the middle o... Read more
feeling like I was going to pass out; Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside. Pockets have gone down but are still visible after 6 days.; while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside.; severe hot flashes; chills; felt like I wanted to vomit; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old female patient received first dose of bnt162b2 (BNT162B2 Solution for injection) via an unspecified route of administration, administered in arm left on 12May2021 12:00 (Batch/Lot number was not reported) as first dose, single for COVID-19 immunization. Medical history included obesity, atrial fibrillation, cardiac failure from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took sulphonamides, beta methasone, prilosec. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. The patient was not hospitalized. On 12May2021 at 12:00 AM, Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like large worm inside. Pockets have gone down but are still visible after 6 days. The worst part, was that got severe hot flashes then chills, feeling like I was going to pass out. Then felt like wanted to vomit. This went on for 24 hours, but now has seemed to stop. The outcome of the events was recovering. Information about lot/batch number has been requested.
80 2021-05-28 pain in extremity, weakness I was very tired and my arm was a little bit sore and I ran a 99 temperature that just made me mise... Read more
I was very tired and my arm was a little bit sore and I ran a 99 temperature that just made me miserable. I sat around and didn't do anything because I didn't have any energy. It lasted 3 days until 02/29/2021. I did not see my Doctor for this.
80 2021-05-28 pain in extremity Moderate pain in her arm; This is a spontaneous report from a contactable consumer (patient herself)... Read more
Moderate pain in her arm; This is a spontaneous report from a contactable consumer (patient herself) via a medical information team. An 80-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 24May2021 (at the age of 80-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant mediations were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. It was reported that, caller, female, aged 80, received her second dose of the Pfizer BioNTech Covid 19 vaccine yesterday on 24May2021. She was now (on an unspecified date in May2021) having moderate pain in her arm and was wondering how long it might last. The event was considered as non-serious by the consumer. The outcome of the event was unknown. Information on the lot/batch number has been requested.
80 2021-05-28 pain in extremity When she woke she felt like she did when she had Covid/felt like she had Covid; Chills; headache; te... Read more
When she woke she felt like she did when she had Covid/felt like she had Covid; Chills; headache; temperature of 99.6-100.1F/Fever; I still felt a little tired; my arm was killing me; felt weird; felt weird like she was unsteady on her feet; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient (Weight: 53.52 kg, Height: 157 cm) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 26Feb2021 08:30 as 1ST DOSE, SINGLE for covid-19 immunisation. She is unable to clearly identify the Lot due to illegible handwriting on the vaccine card. She thinks it is EN6200 or EN06200. Vaccination Facility Type: Clinic sponsored by (Name). Vaccine not administered at Military Facility. Medical history included covid-19 from 2020. She was also told that she might not need to get the second dose because of having antibodies. When she had Covid it was mild. She did not have the traditional symptoms. It affected her gastrointestinal system more. It was weird. Prior Vaccinations (within 4 weeks) was None. There were no concomitant medications. On 26Feb2021, after she got the vaccine, her arm was killing her. It was awful. She took Tylenol for it. Around 3-4pm she was feeling a little bit weird/"felt a little funny" like she was unsteady on her feet. She was not dizzy. She woke up the next day, 27Feb2021, felt "rotten", "almost like I felt when I had covid/ felt like she had Covid. Same symptoms, milder form": slight headache for 3 hours, chills lasted a couple of hours, temperature of 99.6-100.1F for 3 hours. She was awful in the morning and better as the day went on. It remined her of when she had Covid. After symptoms went away, she still felt a little tired. Didn't feel as good as she did before the day she took the vaccine. Caller said the vaccination Nurse told her that she might have more reaction because she may still have antibodies. Caller asking did she need to get 2nd dose? Should she expect reactions from the second dose? She still plans on taking it. The outcome of arm was killing her was recovering. Her arm is better but if she lays on her arm she can still feel it. The outcome of felt a little tired was unknown. The patient was recovered from other events on 27Feb2021. Information on the lot/batch number has been requested.
80 2021-06-02 pain in extremity started of with just muscle pain in left arm, as time went on, both arms,shoulders, legs, are all qu... Read more
started of with just muscle pain in left arm, as time went on, both arms,shoulders, legs, are all quite painful. they get worse when not moving,move arms hard to stand up, or
80 2021-06-06 numbness It was an extremely painful shot. It was a screaming painful shot. Once I made it home my pinky fing... Read more
It was an extremely painful shot. It was a screaming painful shot. Once I made it home my pinky finger was numb and I couldn't move my arm above my head. It was hard lifting my hands and arms.
80 2021-06-07 depressed level of consciousness, numbness Reduced consciousness; Pain and swelling in the arm where she received the shot; Pain and swelling i... Read more
Reduced consciousness; Pain and swelling in the arm where she received the shot; Pain and swelling in the arm where she received the shot; Slight fever; Chills; Heart rhythms; Tiredness; Sudden severe headache; Imbalance; Trouble walking; Dizziness; Vertigo; Slight vision changes; Confusion; Numbness or weakness of one side of her leg; Numbness or weakness of one side of her leg; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO9269), via an unspecified route of administration in right arm, on 10Feb2021 at 14:15 (at the age of 80 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included stroke (few years ago), multiple hip transplants, and rheumatoid arthritis (for 35 years). The patient's concomitant medications included apixaban (ELIQUIS) and metoprolol tartrate. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a clinic. On 11Feb2021 at 16:45 PM, normal side effects felt are pain and swelling in the arm where she received the shot. In addition, the patient may have a slight fever, chills, heart rhythms, tiredness, headache, and imbalance (trouble walking) on 11Feb2021 at 16:45 PM. On the patient's first two days (starting on 11Feb2021 at 16:45 PM), the patient experienced dizziness or vertigo, slight vision changes, sudden severe headache, confusion or reduced consciousness, and numbness or weakness of one side of her leg. It was unknown if treatment was given for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Sudden severe headache", "Dizziness", "Vertigo", "Slight vision changes", "Confusion", "Reduced consciousness", and "Numbness or weakness of one side of her leg" in Feb2021; and from the other events in 2021. No follow up attempts are possible. No further information is expected.
80 2021-06-08 pain in extremity, tingling severe headache on 2nd day, exhausted for 3 weeks, mild chills, extreme burning in chest, passed wit... Read more
severe headache on 2nd day, exhausted for 3 weeks, mild chills, extreme burning in chest, passed within 12 hours, tingling in hands and arms and itching, low blood pressure, sporaitic left arm and elbow pain, lower stomach cramps, diarrhea, out of breath
80 2021-06-08 pain in extremity had a red patch that was hot around the site; The muscles in her entire right arm are very sore and ... Read more
had a red patch that was hot around the site; The muscles in her entire right arm are very sore and says that it's painful; had a red patch that was hot around the site; red patch on my arm was just red and hot and hard; The muscles in her entire right arm are very sore and says that it's painful; This is a spontaneous report received from contactable consumer (patient). An 80-year-old female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9267, and Expiration date: Unknown), via an unspecified route of administration, administered in upper right arm on 25Feb2021 as 2nd dose, single dose for COVID-19 immunization. The patient's medical history included psoriatic arthritis, Deaf (I am on a 'casting' call phone because I am deaf) and the patient also took Penicillin (I was three years old saved my life). The patient's concomitant medications were not reported. The patient stated that she took lot of medications (unspecified) she had a set of "tremor", it was a long list. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269, and Expiration date: Unknown) in left arm on 04Feb2021 as 1st dose, single dose for COVID-19 immunization. The patient had infusion of Simponi on 04Feb2021 the same day she took first dose of vaccine. No other vaccine was administered prior to first dose of COVID vaccine. It was reported that the patient experienced a side effect after getting the second dose of the Pfizer-BioNTech COVID-19 Vaccine on an unspecified date in 2021. Originally, she had a red patch that was hot around the site in the hand for about two weeks. The muscles in her entire right arm are very sore and said that it's painful when she reached. The entire arm was painful and uncomfortable, and it was getting worse. On an unspecified date in 2021, the patient was recovered from the event "red patch on my arm was just red and hot and hard" and outcome was unknown for the event "the muscles in her entire right arm are very sore and says that it's painful" Follow up needed, further information has been requested.
80 2021-06-16 feeling hot This is a spontaneous report from two contactable Consumer or other non-HCP (Patient and Patient's S... Read more
This is a spontaneous report from two contactable Consumer or other non-HCP (Patient and Patient's Son). These two consumers reported for 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: EL9261; Expiry Date was not reported), via an unspecified route of administration in arm left on 02Feb2021, (80-years -old at the time of vaccination), as first dose, single dose for COVID-19 immunization. The patient's medical history included fall, she went to the hospital for this, was a year ago and diabetes mellitus. The patient's concomitant medications included Metformin that she could take it only when her blood sugar is up, and Flu shot had it 3 weeks ago. On 03Feb2021, the patient experienced face swelling, the swelling was mostly around the eyes as if she was sting, it looks like little water bags, it doesn't hurt, there was no pain, it was underneath both eyes and down the cheeks, just swelling, swelling feels warm to the touch, and the skin was red, it's not red all over but in patches on cheeks and below the eyes, there was also redness right below chin, and it stops at the chin and there was redness on the forehead. On an unspecified date, the patient underwent lab tests and procedures which included blood glucose: 98. The outcome of all the event face swelling was not recovered and the event swelling feels warm to the touch and the skin was red was unknown. Follow-up attempts are completed. No further information is expected.
80 2021-06-20 weakness Asymptomatic COVID-19 infection, possibly related to the stroke follow-up with family doctor. ED to... Read more
Asymptomatic COVID-19 infection, possibly related to the stroke follow-up with family doctor. ED to Hosp-Admission Discharged 5/28/2021 - 6/2/2021 (5 days) Hospital MD Last attending ? Treatment team Lacunar stroke Principal problem HPI: 80-year-old lady admitted with left-sided weakness Hospital Course: Patient was admitted with left-sided weakness. MRI showed a 9 x 8 mm acute lacunar infarction in the right thalamus. This was the likely cause of the patient's left-sided weakness. Patient has asymptomatic COVID-19 infection diagnosed May 13. The stroke may have been a late effect of a hypercoagulable state induced by COVID-19. In any case the patient's deficits rapidly resolved and by the day of discharge she was at her baseline. She had no difficulty walking or functioning. She was seen by physical and Occupational Therapy who felt that she was safe to go home. To prevent this from happening in the future we are increasing her atorvastatin from 20 mg to 40 mg daily. She is already on warfarin. She was seen by the neurology service and they did not recommend making any other changes especially in view of the patient's history of gastrointestinal bleeding. On the day of discharge she was feeling very good and eager to go home. I think this is reasonable.
80 2021-06-22 slurring, weakness Chills, low fever, nausea, sneezing, runny nose, diarrhea, aching, weakness, unclear thinking, metal... Read more
Chills, low fever, nausea, sneezing, runny nose, diarrhea, aching, weakness, unclear thinking, metallic smell and taste- severe at times, slurred speech
80 2021-06-24 weakness neck felt really weird, her whole neck was hurting; very tired; Fever; pain in the stomach; Dry heav... Read more
neck felt really weird, her whole neck was hurting; very tired; Fever; pain in the stomach; Dry heaves; back was hurting; no energy; knee hurting; got so sick; delusional; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot: EL2346) via unspecified route of administration on 15Jan2021 09:57 as single dose in arm right for COVID-19 Immunization. Medical history reported was thyroid, blood thinner and degenerative disc disease, all ongoing. Concomitant medications reported was rivaroxaban (XARELTO) ongoing as blood thinner taking for many years, levothyroxine ongoing for thyroid it was 25 and they no product taking for 5 years and prednisone from 21Jan2021 till 26Jan2021 for degenerative disc disease as Blister pack take six, then five, and down to one daily by mouth for six days. No prior vaccinations within 4 weeks was reported. Consumer called to report side effects. Stated she received the first dose of the Pfizer COVID 19 vaccine 15Jan2021 at 09:57AM in the right arm. Six days later all of the sudden in the evening she got so sick with pains in her stomach; dry heaves but she didn't throw up; felt horrible with no energy. She didn't even brush her teeth or undress to go to bed. In the night she had a fever, but she was so sick she couldn't reach overtake her temperature. She heard a voice saying, "what is your temperature". She thought she was delusional. She woke up and her knee was hurting, and her back was hurting. She had a knee replaced in Jul2020 and sometimes has trouble with it. She was diagnosed with degenerative disc disease and the doctor put her on prednisone pack for her back pain. The next day she felt better but her stomach was still bothering her, and she was so very tired. She hasn't been out, and it wasn't like she picked up anything. The next night Saturday her neck felt really weird, her whole neck was hurting. She was tired until Wednesday. Outcome of the event pain in the stomach was recovered on 24Jan2021, Dry heaves recovered on 21Jan2021, no energy, neck felt really weird, her whole neck was hurting was recovered on 22Jan2021, very tired was recovered on 27Jan2021, back was hurting, knee hurting, fever was recovering and for remaining events its unknown. Follow-up attempts are completed. No further information is expected.
80 2021-06-24 weakness Felt weak; Dry throat; States she has noticed she has been burping a lot and coughing harder.; State... Read more
Felt weak; Dry throat; States she has noticed she has been burping a lot and coughing harder.; States she has noticed she has been burping a lot and coughing harder.; She has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up; she has been having shortness of breath that started when she got the first dose of the Pfizer COVID vaccine on 27Jan2021; Chills; she just felt tired was all; pain at the injection site in her right arm so she took Tylenol that morning; This is a spontaneous report from a contactable nurse (patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265) dose 1 via intramuscular route of administration in Arm Right on 27Jan2021 at 13:30(at the age of 80 years old) as single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. Patient had no other vaccines on the same day as the COVID vaccine. The patient experienced as, she has been having shortness of breath that started when she got the first dose of the pfizer covid vaccine, chills, she just felt tired was all, pain at the injection site in her right arm so she took tylenol that morning on 27Jan2021, felt weak on 07Feb2021, she has noticed she has been burping a lot and coughing harder, she has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up, and dry throat on an unspecified date on Feb2021. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. The patient underwent lab tests and procedures which included weight: 145-147 on an unspecified date. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. Outcome of the event shortness of breath and chills were recovered and unknown for rest events. Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.
80 2021-06-24 pain in extremity very, very sore arm; This is a spontaneous report from a contactable consumer (patient) via medical ... Read more
very, very sore arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. An 80-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261; Expiration Date: 31May2021), via an unspecified route of administration administered in left arm on 05Feb2021 at 10:40 (age at vaccination was 80 years) as 1st dose, single for COVID-19 immunization. The patient's medical history included high blood pressure, acid reflux, allergies to like cats and stuff like to tree if she got too close to them, she smoked for years 2 puffs every other morning, she had some beginning touches of COPD she thinks. She had a lot of problems or anything with COPD, she just got out of breath sometimes, but she was also getting old. Patient concomitant medication included amlodipine (AMLODIPINE) and hydrochlorothiazide, losartan potassium (LOSARTAN/HCTZ) both taken for high blood pressure been on this product for years and ongoing, omeprazole (OMEPRAZOLE) taken for acid reflux, tiotropium bromide (SPIRIVA) taken for chronic obstructive pulmonary disease from an unspecified start date and ongoing and atorvastatin (ATORVASTATIN) taken for an unspecified indication from an unspecified start date and ongoing. Patient was on no blood thinners. The patient's family history included one sister was dead, had asthma and allergic to everything. Her other sister had a heart attack and recovered very well but she was only 62 years old. One of her brothers died of brain cancer; and another brother died in his sleep of a heart attack. They have a lot of heart problems in the family. Her mother also had a heart attack and recovered but was no longer with us but also had emphysema. Her father died in 1968 of the Hong Kong Flu. The patient previously got the Flu shot on unspecified date in Sep2020 and had kind of punky/punchy/ugh; but nothing where it keeps her down in bed or anything like that. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no additional vaccines administered on same date of the Pfizer suspect. On 05Feb2021 around 12:00-13:00 the patient experienced very, very sore arm and it does not seem to be getting any better. The patient inquired if she could take Tylenol or Motrin for the very, very sore arm and if it will reduce the effect of the vaccine, as she was scheduled to had second dose on 26Feb2021. The outcome of the event was not recovered. Follow-up attempts completed. No further information expected.
80 2021-06-24 tenderness, pain in extremity the injection site is red and swollen/swelling with red silver dollar spots; arm is sore; she had a ... Read more
the injection site is red and swollen/swelling with red silver dollar spots; arm is sore; she had a very red and tender arm; the injection site is red and swollen; This is a spontaneous report from a contactable consumer (patient herself). An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an unspecified route of administration, administered in right arm on 29Mar2021 14:20 (reported as Monday) (age at vaccination: 80 years) as DOSE 2, SINGLE for covid-19 immunization at Physician Office. The patient medical history was not reported. Concomitant medication included levothyrxoine sodium (SYNTHROID). The patient said that she was basically healthy. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in his right arm on 08Mar2021 as DOSE 1, SINGLE for covid-19 immunization. Patient was was okay with the 1st Covid shot. The night after the second shot, she had a very red and tender arm. The next morning, it was red and swollen and redder. It has been the same for the last 2 days. The arm was sore with red patches the size of 2 silver dollars. Patient took a Benadryl thinking that would help and used an ice patch. The arm was a little redder this morning. Caller added that pain wise and everything, it was about the same. The discomfort was about the same. The area was redder and the redness has worsened as in bigger than it was last night.The patient had no prior vaccinations within 4 weeks. The outcome of the event was not recovered.
80 2021-07-01 pain in extremity sore arm; tired; headache; throw up; This is a spontaneous report from a contactable consumer, the p... Read more
sore arm; tired; headache; throw up; This is a spontaneous report from a contactable consumer, the patient. A 80-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) into left arm on 19Mar2021 at 10:30 (at the age of 80-years-old) as single dose for COVID-19 immunisation. The patient's medical history included open heart surgery. The patient's concomitant medications included atorvastatin 20 mg (MANUFACTURER UNKNOWN), levothyroxine 100 mcg (MANUFACTURER UNKNOWN) for and multivitamins (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date. The patient had an allergy towards amoxicillin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been diagnosed with COVID-19. On 20Mar2021 at 07:00, the patient experienced sore arm, tiredness, throw up and headache. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, tiredness, throw up and headache was recovered on an unknown date. No follow-up attempts possible. No further information expected.
80 2021-07-08 discomfort I was having side effects during the vaccine a headache and then nausea, throat soreness, face redne... Read more
I was having side effects during the vaccine a headache and then nausea, throat soreness, face redness, neck redness, rash on chest. Pain in lower abdomen. Pressure around left ankle.
80 2021-07-11 numbness Numbness and tingling in hands, feet, arms, and legs. Trouble walking. Trouble with balance .
80 2021-07-11 tingling pruritis/itching all over; she is still tingling around her shoulders and neck; This is a spontaneou... Read more
pruritis/itching all over; she is still tingling around her shoulders and neck; This is a spontaneous report from a contactable consumer reported for herself. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Batch/Lot Number: EN6200) via an unspecified route of administration on 20Feb2021 13:30, as dose 1, single for COVID-19 immunization. Medical history included ongoing blood pressure, ongoing cholesterol, and ongoing acid reflux. Concomitant medications included algeldrate, alginic acid, magnesium trisilicate, sodium bicarbonate (GAVISCON [ALGELDRATE; ALGINIC ACID; MAGNESIUM TRISILICATE; SODIUM BICARBONATE]); esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) taken as Antacid; vitamin d nos (VITAMIN D NOS); vitamin A; and blood pressure medicine (unspecified). On 20Feb2021 (Saturday), the patient got the first dose 20Feb2021 and the itching started after midnight. On 21Feb2021 at 02:00 AM, she experienced itching all-over, but it had diminished and was now on her shoulder and neck area. She noticed, it got worse after she has taken her reflux medication Nexium and Gaviscon and wanted to know the expected duration of this side effect. She mentioned that she had vaccine, Saturday at about 1:30 PM it was reported that it went fine but at about 2 AM she woke up itching and she didn't think anything about it and thought it would go way but continued and it gets worse when she takes her antacid. She quit taking her Nexium, it got worse with that antacid. It was a little better, but on an unspecified date in 2021, she was still tingling around her shoulders and neck and wanted to report it, but she also wanted to see how long she might have this problem or when would it go away finally. As her itching started after midnight and was fine until then which was why she thought it was something to do with her acid reflux medicine because she took it before she went to bed and then yesterday, she took Gaviscon, and the itching got worse. She says it was like Pepcid or something like that, it was an antacid. She also took her prescribed medication for acid reflux. It was improved but it was still there. Further she added that it was not like she itches and scratches all the time, but it was just there, mainly around shoulders and neck. She was startled she had any reaction because she did not right at first but might be people should know that you still could have a reaction. She took the Nexium that night before and she had taken all her medicines as well which was her blood pressure medicine, cholesterol medicine, Nexium, vitamin D and A vitamin. She had taken all of those the night she started itching. Last night all she took was her blood pressure medicine. She also had taken Tylenol and when she started itching like when it was bad, she took some, it was like allergy relief like Zyrtec (generic). Last night all she took was blood pressure medicine because she did not want to mess with anything. She had not taken any antacid since about 12 yesterday morning and the itching got worse than that was why she was thinking maybe that was the problem. Therapeutic measures were taken as a result of the events with Tylenol and Zyrtec. The outcome of the event pruritis/itching all over was resolving, while the outcome of the other event was unknown. No follow-up attempts are possible, no further information is expected.
80 2021-07-17 difficulty speaking Saw throat; I had no voice for 12 days.; Voice came back hoarse; This is a spontaneous report receiv... Read more
Saw throat; I had no voice for 12 days.; Voice came back hoarse; This is a spontaneous report received from a contactable consumer, the patient. An 80-year-old non-pregnant female patient received an unspecified dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 04Feb2021 at 15:30 (at the age of 80-years-old), as a single dose for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease), heart disorder. The patient had a history of known allergies. The patient had received unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Feb2021, the patient experienced saw throat. It was reported that the patient had a saw throat for 4 days then she had no voice for 12 days. The patient's voice came back hoarse and was still that way. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure taken included speech therapy. The clinical outcome of the event saw throat and hoarse voice was not resolved while that of loss of voice was resolved on an unknown date. No follow-up attempts are possible; information about lot number cannot be obtained.
80 2021-07-25 facial pain, nerve pain Diarrhea for several days, Swollen face, shooting nerve pains in face and head, face painful to the ... Read more
Diarrhea for several days, Swollen face, shooting nerve pains in face and head, face painful to the touch, as if nerves inflamed. Doctor suspected shingles, but no blisters appeared. Pain stopped after five days. Swelling lasted a couple of weeks. Irritated nerve sensation in trunk persists,
80 2021-07-27 burning sensation, pain in extremity, weakness both forearms ache; chest felt heavy; lips swelled; eyelids drooped; hands were weaker than usual; w... Read more
both forearms ache; chest felt heavy; lips swelled; eyelids drooped; hands were weaker than usual; whole right side was weak; she could not eat; could not digest food; Lost weight; she got continual heartburn and burped throughout the day after she ate; felt burning; Her stomach was knotted, she could feel her stomach closing up on her; Her stool was mush for the whole three months, it finally got to droplets that turned to mush.; it affected her digestive system and her release of the stools.; Her forehead was very much wrinkled; has a lot of food intolerances and it is not new that she is intolerant; This is a spontaneous report from a contactable consumer or other non hcp. An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration, administered in Arm Left on 01Mar2021 (at the age of 80-years-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She does not take pills. She takes vitamins but states that does not count. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9262) via unspecified route of administration, administered in Arm left on 08Feb2021, in the morning around 9:30 or 10am (at the age of 80-years-old) as dose 1, single for covid-19 immunisation. It was reported that she thinks she should report the difficulty she had with the vaccine since it was not the usual adverse reactions and it was extended. She went to doctor several times. She was wanted to know how to deal with it. Clarifies she does not have a question since this was no longer part of her system. She woke up every morning between 05:30 and 07:00 am and was awoken by both forearms aching. Then it got to where the right forearm ache was worse than the left. Sometimes she felt burning. Her chest felt heavy. Her lips swelled. Her eyelids drooped; left eyelid drooped more than the right eyelid. Her whole right side was weak. When she wrote her right hand was weaker than usual. The worst reaction was that she could not eat, she could not digest food, her digestion was completely off. When she went to doctor, she weighed 92 pounds since she got continual heartburn and burped throughout the day after she ate, and this continued for hours. She had to make special food for herself since she could not digest/ eat most food. She ate fish, bread, and potato. She could not digest anything heavy. Her stomach was knotted, she could feel her stomach closing up on her. She was fearful of eating. Her stool was mush for the whole three months, it finally got to droplets that turned to mush. The main thing as she said, it affected her digestive system and her release of the stools. She lost 8 to 10 pounds. She kept a diary of her food and feelings for months. Her forehead was very much wrinkled, she has wrinkles anyways since she was old, but she had wrinkles in her wrinkles. She had a lot of food intolerances and it was not new that she was intolerant. Her body had many intolerances such chocolate, lactose, nuts, and some medications. She cannot eat anything with any chemicals such as msg and yellow food dye. She cannot eat deli meat since it contains some chemical. At first, she didn't realize it and did not know what was going on with her body, she noticed the side effects mentioned above more after the second dose which was given on 01Mar2021. It took three and half months and finally went it all went away, recovered completely. The patient was recovered from all the events on an unspecified date. No follow-up attempts required. No further information expected.
80 2021-07-27 nerve pain Headache; Right arm funny bone nerve pain that would go all the way up and down arm; nerve pain; UTI... Read more
Headache; Right arm funny bone nerve pain that would go all the way up and down arm; nerve pain; UTI; she is still dizzy and having bad effects for the UTI; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot/NDC number: Unknown; Expiry date: Unknown) via an unspecified route of administration in left arm on an unknown date in 2021 14:00 (at 80-year-old) on left arm as single dose for COVID-19 immunization. The patient's medical history thyroid issues was over 30 years ago, penicillin allergy (since 1964) that gave her hives so bad. loaded with hives and was a pimply mess, ongoing doxycycline allergy that gave her severe diarrhea, sulfonamide allergy, iodine allergy, fever and could not breathe/extreme difficulty breathing. The past drug event included tetracycline, arithromycin, Levaquin, ceftin, Zithromax that caused drug allergy (ongoing). Concomitant medications included levothyroxine (Other products: Yes) taken for thyroid disorder (had it for 30 years or more and had been taking for the same then). The patient previously took doxycycline and experienced diarrhoea, tetracycline and experienced drug hypersensitivity, erythromycin and experienced drug hypersensitivity, levaquin and experienced drug hypersensitivity. It was mentioned that no investigation assessment was done. She came home on an airplane on 03Jan2019, the year COVID started. When she got back, she told her doctor she thought she had gotten Covid, so they tested her, but she was negative. She thought she had it and volunteered for antibodies. She did not get over it until mid Jan2019. They told her she was over it for too long though if she had it. It was mentioned that history of all previous immunization with the Pfizer vaccine, prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration were reported as none. Received call from consumer regarding the Pfizer COVID vaccine. She has ongoing symptoms that started after she received the vaccine. She only got the first dose. On an unknown date in 2021, she started having headaches that she never knows when they are going to come on and they are continual. She did not have them before she got the vaccine. She did not remember the start date and said it was right away after the first dose that she received about a month and a half ago. It started right away. She was not getting the second one because the headaches would not go away. They become more continuous and more often. She was hesitant to get the vaccine because she was allergic to just about all antibiotics. She does not have names, lot or expirations for any. She later provided that Penicillin gave her hives so bad. She was loaded with hives and was a pimply mess. She also said that Doxycycline gave her severe diarrhea. She then found her list and also provided allergies to the following: Tetracycline, Arithromycin, Sulfa, Levaquin, Ceftin, Zithromax, and no contrast Iodine. She does not remember the exact reaction. It is either severe hives or severe diarrhea. She does not have the lot or expiration for any of them. No further details provided. She had another issues immediately after the shot. She had funny bone pain in the right arm but she got the shot in the left arm. This pain was described as a nerve pain that would go all the way up and down her right arm. It would come at night after the shot but then it went away. She does not have it right now. Right now she was trying to get rid of a UTI. It was recently within the last 2 weeks ago. She started medication for it and they did not help. She had a call into the doctor and she was still dizzy and had bad effects for the UTI. She took the medication and had to refill it. Medication was Nitrofurantoin Mono Mcr 100 mg. One capsule every 12 hours. It was in a pharmacy vial with unknown lot or expiration. She did a refill and took it twice. She finished them and has none left. Her friends were upset because she would not get second shot and certainly not a third because of these headaches. She felt she may take a chance at getting something worse than these headaches. She does not feel she should get them or anymore. The patient did not require emergency room and physician office visit. She had been to her doctor since and she mentioned the headaches, and all they say was to take Advil. Outcome of the events headache, urinary tract infection and dizzy was not recovered, whereas other events were recovered on an unspecified date in 2021. Description of Product Complaint: Description of complaint: Right now she is trying to get rid of a UTI. It is recently within the last 2 weeks ago. She started medication for it and they did not help. She had a call into the doctor and she is still dizzy and having bad effects for the UTI. She took the medication and had to refill it. Medication is Nitrofurantoin Mono Mcr 100 mg. One capsule every 12 hours. It is in a pharmacy vial with unknown lot or expiration. She did a refill and took it twice. It was mentioned that product strength and count size dispensed: 100mg, 14 count. Information on lot/batch number had been requested.
80 2021-07-28 pain in extremity Losing balance, leaning to one side; Diarrhea; Pain in legs cannot stand, pinching like small animal... Read more
Losing balance, leaning to one side; Diarrhea; Pain in legs cannot stand, pinching like small animals in body; Pain in legs cannot stand, pinching like small animals in body; Can barely walk legs hurt so much; Feels like she is dragging one leg; Itchiness on body; Feeling quite weird; This is a spontaneous report from a contactable consumer or other non hcp. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 1st dose. An 80-years-old female patient received BNT162b2 (Pfizer Covid Vaccine, Solution for injection, lot number: EN0196, NDC and expiry date was unknown), via an unspecified route of administration, administered in Arm Left on 27Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN0164), via an unspecified route of administration, administered in Arm Left on as 07Jun2021 as 1stdose, single for covid-19 immunisation. Medical history included deep vein thrombosis from an unknown date and unknown if ongoing Verbatim: DVT Thrombosis Right Leg. There were no concomitant medications. The patient experienced itchiness on body on 27Jun2021 with outcome of recovered , feeling quite weird on Jun2021 with outcome of unknown , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , can barely walk legs hurt so much on Jul2021 with outcome of not recovered , feels like she is dragging one leg on Jul2021 with outcome of not recovered , losing balance, leaning to one side on an unspecified date with outcome of unknown , diarrhea on an unspecified date with outcome of unknown. Outcome of the events experienced itchiness on body was re-covered, feeling quite weird, losing balance, leaning to one side diarrhea was unknown, pain in legs cannot stand, pinching like small animals in body, pain in legs cannot stand, pinching like small animals in body, can barely walk legs hurt so much, feels like she is dragging one leg was not recovered .
80 2021-07-29 muscle spasms, pain in extremity This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient r... Read more
This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 18Mar2021 (at the age of 80-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Feb2021 (at the age of 80-years-old) (Batch/Lot number was not reported) for COVID-19 immunisation and had pain in her arm. The patient reported that she had first shot on 25Feb2021 and followed the procedure 21 days later and received second shot on 18Mar2021 after the first shot. When probed for second shot vaccination timings, consumer stated, "her second shot was on "319" (Further not clarified). On 19Mar2021, she woke up and her teeth were killing her like she slept she was fine but in the morning she had terrible toothache and she was taking care of her teeth, she had Flu like symptoms her eyes puffed up, swelled and runny nose, she went to a Dermatologist Doctor and she gave her some medicine to take swelling down, she had severe leg cramps and could hardly barely walk. She was trying to find out if she could have blood clot, she could have everything, she went to funeral and she had to leave early, she left and fly back Home, it disturbed her, it could be from Pfizer shot. She was 80 years old and she was not be able to, she should be hardly be able to function. Consumer stated, she was in pain and on pain medication, she was in terrible pain because her legs and back hurting so much. Her eyes swelled up badly. When probed for any laboratory test, consumer stated, she had pain today, she walks 3 miles a day, today she probably walked a mile and it was painful. She went Dermatologist for her eyes. Consumer stated, she went to a Dermatologist to see why her face is swallowed up. She would like to be followed up, what she was to do with her pain, she was like crippled, she was in pain all the time, she would like to know Pfizer to tell her what medication she needs to take. She did not know, the Doctor knows what to give. She needs them to recommend what they are giving to other people those are having these severe reactions. Consumer stated, she had two Pfizer shots (both doses) and she had a severe adverse effect. Now it was difficult she had severe pain in her legs. she walks 3 miles a day. she had her eyes swell as well, she went to a Dermatologist. She walks to her Doctor after the severe pain from the Pfizer shot, he gave her some pain treatment Tramadol and "Ibuprofen" (not clarified) besides the fact that it will help. She started to walk, she sneeze a lot, swelled up like her eyes swelled up and she had sticky stuff that was for 9 days, no apparent reason then she went to the Dermatologist. She had severe swelling then she had her teeth ache, for eye condition and skin she went to Dermatologist and he gave her "Hydrocortisone" (name not clarified) several days for two weeks and her teeth have no pain in her teeth. She woke up this morning and felt cry it was painful and she don't know what to do about this adverse effect. she wanted to ask to Pfizer people to get medicine. The caller has had severe adverse effects after receiving the Pfizer Covid 19 Vaccine. The caller could barely use her legs, the legs were in severe pain. The caller was a person that walked and exercised, walked 3 miles a day. The caller could barely get around, and up and down in the morning is hell. The caller was so weak and the legs hurt so bad. The other effect was the caller's eyes swelled up and ran sticky oozy stuff. The caller went to the dermatologist and was given cortisone and after 14-15 days that cleared up, it was white. The caller went to her doctor about the pain in her legs. The caller was taking Tramadol and Ibuprofen and they were not a lot of help. The doctor said it will run its course. The caller asked how long it will be and the doctor said the good news is it will go away and that is about all the doctor would say. In the mean time, the caller was in severe pain and is asking what can be taken for the legs. The caller states she had been in severe pain since February. The caller states if she is not going to get any help why this was not put on the news report. All it is go get another shot. No reports on how it may have these adverse effects. Another thing is the caller goes to bed at night fine and wakes up in the morning with jaws and teeth killing the caller. The caller had excellent dental work. The caller's eyes still run, continually run. The caller states she specially asked what the caller can get for some relief from the pain or is the patient to call the rest of her life. The caller states she could walk. The caller said Pfizer doesn't report a thing, no side effects, everybody is shut up on tv. The caller thinks the side effects, percentages and dangers for the elderly like the caller and the young, young children should be told. The caller states she did talk to her doctor and he gave the caller tramadol (50mg, Expiration date: 12Jul2022) and Ibuprofen (Expiration date: 21Jun2022). Outcome of the event toothache was recovered in 2021; eye discharge was not recovered; other events was unknown. Information about the Lot/batch number has been requested.
81 2021-01-13 pain in extremity She complained that after receiving the vaccine her arm felt heavy and sore to movement. She was ev... Read more
She complained that after receiving the vaccine her arm felt heavy and sore to movement. She was evaluated EMT and released home feeling better at 1:39 pm.
81 2021-01-15 flushing difficulty breathing, flushed
81 2021-01-18 weakness 12/28/2020: generalized weakness and fell twice at home, cough, nausea,1/04/2021: cough, nausea, fev... Read more
12/28/2020: generalized weakness and fell twice at home, cough, nausea,1/04/2021: cough, nausea, fever and chronic pain when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on bipap, 1/15/2021: pt was intubated, on TPN, pt DNR, 1/18/2021: was extubated and put on comfort measures and passed away
81 2021-01-21 feeling hot, weakness Patient felt faint, hot, weak, had to sit down upon trying to leave the facility after observation p... Read more
Patient felt faint, hot, weak, had to sit down upon trying to leave the facility after observation period. Vital signs stable, blood glucose measured = 89 Orthostatics conducted, negative for orthostatic hypotension Patient given crackers, water. Evaluated by nurse practitioner, advised to take deep breathes, patient felt better and left facility with daughter
81 2021-01-21 pain in extremity, tingling severe back and leg pain, paresthesias bilaterally
81 2021-01-23 inability to speak Within 15 minutes of the injection, the individual became aphasia and stroke like symptoms. She was ... Read more
Within 15 minutes of the injection, the individual became aphasia and stroke like symptoms. She was taken to the ER where she was later diagnosed with a cerebral hemorrhage and passed away.
81 2021-01-25 weakness, discomfort weakness/feeling weak; Dizziness/head was dizzy; nausea; Neck was sore; discomfort; This is a sponta... Read more
weakness/feeling weak; Dizziness/head was dizzy; nausea; Neck was sore; discomfort; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, Expiry Date: Apr2021), via an unspecified route of administration at right arm on 08Jan2021 13:00 at single dose for covid-19 immunization. Vaccine was not administered at military facility. Vaccination facility type was health department. The patient got the flu shot every year and never had a problem. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021, the patient experienced severe dizziness/head was dizzy, feeling weak, nausea, neck was sore. The events did not require a visit to emergency room or physician office. She was very dizzy and laid back down. Today (14Jan2021) was better but she felt weak and wanted to figure out what was going on. She took it to make sure she felt better but the only thing she's had was discomfort. No treatment, not contacted the doctor. The outcome of events weakness/feeling weak, dizziness/head was dizzy was recovering. The outcome of events nausea, neck pain was not recovered. The outcome of event discomfort was unknown.
81 2021-01-25 weakness Resident was fine Day of the vaccine. The pharmacist stayed after for 30 minutes to check the well-b... Read more
Resident was fine Day of the vaccine. The pharmacist stayed after for 30 minutes to check the well-being of the residence. Three days later resident was feeling weak wasn?t able to stand so we had to get a chair for her to sit in which was unusual. We did rapid testing and it was the only positive in the facility.
81 2021-01-26 weakness, pain in extremity Unsure of the site. this was administered by the Walgreens staff at our branch. She reported on 1/27... Read more
Unsure of the site. this was administered by the Walgreens staff at our branch. She reported on 1/27/2021 that she had leg pain, weakness, SOB heart racing. She reported this started on 1/26/21 overnight but did not report. VS T102.0, P-108, R26, BP152/66 POX 96% on RA. This nurse unsure if this needed reported called the Walgreens pharmacy and spoke to the pharmacist per Walgreens covid 19 rep. Pharmacist instructed to report.
81 2021-01-28 bell's palsy Left sided Bell's palsy.
81 2021-01-28 pain in extremity chills; tiredness; temperature was 100.8; sore arm with redness; sore arm with redness; This is a sp... Read more
chills; tiredness; temperature was 100.8; sore arm with redness; sore arm with redness; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left arm on 12Jan2021 at a single dose for covid-19 immunisation. Medical history included covid-19 in Apr2020. There were no concomitant medications. On 13Jan2021, the patient experienced chills and tiredness and at the end of the day, her temperature was 100.8. The patient also experienced sore arm with redness in Jan2021. The patient stated that every once in a while, she get a shot and get a sore arm. She added that she noticed that her arm was more sore with redness that morning of reporting. The outcome of events chills, tiredness and temperature was 100.8 recovered on 14Jan2021, event sore arm with redness was not recovered. Information on the lot/batch number has been requested.
81 2021-01-31 weakness Sick; Got real weak; Just did not feel right; Aching; Headache; Fatigue; Drowsiness; This is a spont... Read more
Sick; Got real weak; Just did not feel right; Aching; Headache; Fatigue; Drowsiness; This is a spontaneous report from a contactable consumer (patient herself). An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. There were no medical history and concomitant medications. Patient stated she got sick after the shot on 14Jan2021 and she got her first Covid vaccine on Thursday 14Jan2021, she did not know how to get an appointment, said to make an appointment for her second dose, stated she tried to make an appointment for 04Feb2021 and they told her everything was booked, caller was looking for availability of the vaccine in her area, stated she cannot drive all the way to get the second vaccine. She had some aching, headache, fatigue, drowsiness and got real weak and just did not feel right on 14Jan2021. She stated she really wanted the vaccine because they have lost 5 people in her neighborhood to Covid. Caller wanted to know if she should still feel the side effects if that was normal and if when she got the second dose will she be safe from Covid. Caller stated she was still having headache today. Her daughter was nurse and she said those were normal side effects of the shot. She did not want to report this. She was better than she was on Thursday. She was not calling to report anything. She was calling because she was supposed to get the second shot. Outcome of fatigue, drowsiness, sick and not feel right was unknown, outcome of other events were not recovered.
81 2021-01-31 pain in extremity Cough (mild - no trouble breathing) & Diarrhea 1.30 / chills 1.31 / leg & back pains 1.31-2.1 / cont... Read more
Cough (mild - no trouble breathing) & Diarrhea 1.30 / chills 1.31 / leg & back pains 1.31-2.1 / continuing cough
81 2021-02-02 pain in extremity Somewhat sore arm
81 2021-02-02 tingling, numbness Around 1/27/21 patient noticed numbness of bilateral legs and progressive weakness. Admitted to hos... Read more
Around 1/27/21 patient noticed numbness of bilateral legs and progressive weakness. Admitted to hospital 1/29/21 and diagnosed with Guillen Barre. Initially paresthesia was from feet to groin and has been improving.
81 2021-02-02 tingling Pfizer dose #1, 2/2/21 @ 0825 After vaccination was administered, Pt reported tingling in left arm ... Read more
Pfizer dose #1, 2/2/21 @ 0825 After vaccination was administered, Pt reported tingling in left arm that also radiated to BLE feet/toes. Denied SOB/CP/Dizziness/HA. Dr consulted, ordered 10mg Zyrtec SL. Symptoms resolved, Cleared and scheduled for THV follow up. DC home NAD, VSS and in stable condition Allergy eConsult ordered
81 2021-02-03 weakness pain on her left shoulder where they gave her the shot/had pain where they she had the injection in ... Read more
pain on her left shoulder where they gave her the shot/had pain where they she had the injection in her arm; To the point where she felt like she "was going to pass out"; kind of weak/ having "no energy"/ she does not seem to have the energy/ it just droopy; felt dizzy; She has not been sleeping good; having a funny feeling; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), intramuscularly on 15Jan2021 16:15 at single dose in left arm for COVID-19 immunization. Medical history provided as none. There were no concomitant medications. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There were no vaccines received within 4 weeks Prior Vaccinations. The reporter stated she received the first dose of the COVID-19 vaccine on 15Jan2021 (Friday) and felt fine. She added it then made her kind of weak on next Saturday morning on 16Jan2021, to the point where she felt like she was going to pass out on 16Jan2021, but it went away after laying down. She stated she felt pain on her left shoulder where they gave her the shot on 20Jan2021 but is fine today (21Jan2021). Lastly, she mentioned having no energy. She asked if her symptoms were reported sided effects of the vaccine. She has been having a funny feeling in Jan2021 and does not know if it is from the vaccine. She clarifies that she does not seem to have the energy on 16Jan2021. When she got home she was ok, the next day after she got the shot, she thought she was going to pass out and felt dizzy for about an hour on 16Jan2021. She has not been sleeping good for the last few days since Jan2021 and states that may be why she does not have the energy. For event does not seem to have energy, reports it comes and goes, states it just droopy and it may be she had pain where they she had the injection in her arm on 20Jan2021. She is asking if this is normal. The patient declined any Treatment. The reported adverse events did not require a visit to Emergency Room and Physician Office. The reported stated it wasn't that bad. The outcome of event Dizzy was recovered on 16Jan2021. The outcome of the event "was going to pass out" was recovered in Jan2021. The outcome of event "pain on her left shoulder where they gave her the shot/had pain where they she had the injection in her arm" was recovered on 21Jan2021. The outcome of event 'kind of weak/ having "no energy"/ she does not seem to have the energy/ it just droopy' was not recovered. The outcome of the other events was unknown.
81 2021-02-03 flushing Patient was flushed and sweating, seemed to be a little dizzy. Vitals were all okay and within norma... Read more
Patient was flushed and sweating, seemed to be a little dizzy. Vitals were all okay and within normal limits (BP, glucose, O2 Sat, HR). I administered a Benadryl 50mg IM injection to the patient, and the hospital staff later gave her a dose of Zofran as she felt nauseous. Since then the patient seems to be reacting well to treatment.
81 2021-02-04 pain in extremity, muscle spasms muscle spasms, not feeling well and complaining of pain in feet and mouth
81 2021-02-04 pain in extremity, tingling severe back and leg pain and paresthesias bilaterally; severe back and leg pain and paresthesias bil... Read more
severe back and leg pain and paresthesias bilaterally; severe back and leg pain and paresthesias bilaterally; severe back and leg pain and paresthesias bilaterally; This is a spontaneous report from a contactable other hcp. A 81-years-old female patient (not pregnant) received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: sulfa. No covid prior vaccination. No covid tested post vaccination. The patient's concomitant medications were not reported. The patient experienced severe back and leg pain and paresthesias bilaterally on 05Jan2021. The events resulted in hospitalization. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on a drug-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events severe back and leg pain and paresthesias cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
81 2021-02-04 pain in extremity the arm was very sore all the way down to her elbow; Queasy; pasty frequent stool; pasty frequent st... Read more
the arm was very sore all the way down to her elbow; Queasy; pasty frequent stool; pasty frequent stool; the outside of her arm where the vaccine was put hurt that day; This is a spontaneous report from a contactable consumer. A 81-year-old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1284), at single dose into the left arm on 16Jan2021 at 12:30PM for COVID-19 immunization. Concomitant drugs included Levothyroxine 0.100mg once daily by mouth taking for years for thyroid and a week and half before the vaccine administration, she had a cortisone shot in her hip for bursitis but it didn't work, it was the first time she has had one in a long time. The patient reported that on 16Jan2021 the outside of her arm where the vaccine was put hurt that day, but then the next day the arm was very sore all the way down to her elbow. But it was bad, she couldn't roll in bed form the pain. Then she woke up on 17Jan2021 queasy like morning sickness that didn't go away until 21Jan2021. Adds she also noticed that day she was having more frequent and pasty stools. Mentions she expected her arm to be sore because with the second shingles vaccine her arm was sore. States this was years ago and she did not have any product or information for the shingles vaccine. The patient is scheduled for the second dose on 06Feb2021. Mentions she lives in a continuous care facility and they will give her the shot. The event arm hurt recoverd on 20Jan2021, the other events resolved on 21Jan2021.
81 2021-02-04 pain in extremity Big toes hurt, gout; Big toes hurt, gout; Glands in her neck on the right side swollen; Arm is very ... Read more
Big toes hurt, gout; Big toes hurt, gout; Glands in her neck on the right side swollen; Arm is very sore; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL8982) via an unspecified route of administration in left arm on 20Jan2021 mid-afternoon at single dose for COVID-19 immunisation. Medical history included ongoing atrial fibrillation diagnosed about 25 years ago, Canker sore on 18Jan2021 (she did go the doctor for that and the doctor urged her to rinse it with salt water to she's been doing that), some soreness in her month on 18Jan2021, gout reaction. The patient concomitant medications were not reported. No Pfizer vaccine was administered on the same date. Prior Vaccinations (within 4 weeks) was none. The patient got a reaction that she thought should be noted. She has had a very slight history of gout. She woke up this morning on 21Jan2021 and her big toes hurt. She knew that this was a symptom of what she had had in the past which was gout. The patient confirmed her big toes hurting was pretty much staying the same. It's not that uncomfortable. She knew from past experience that this was what happens, like when she ate certain foods like seafood or whatever, she would have this kind of gout reaction. This morning on 21Jan2021, she also felt the glands in her neck on the right side were swollen. The swelling seemed to have gone down. Her army was also very sore. She stated the soreness began last night, in the evening on 20Jan2021. The soreness had pretty much stayed the same. She expected the soreness, but she didn't expect her toes to hurt. It was important to note "she is able to able the gout". She had only had gout really bad time once and then she's had a little bit every so often. The gout just seems to be connected to the vaccine- she could not say nothing that she ate would indicate other wise. The events did not require visit Emergency Room or Physician Office. She had an appointment for 10Feb2021 to get the second COVID-19 vaccine. The outcome of event glands in her neck on the right side swollen was recovering, outcome of events was not recovered.
81 2021-02-05 pain in extremity Very painful upper arm beginning next day. Lasted for 4 days and began to feel much better. Then it... Read more
Very painful upper arm beginning next day. Lasted for 4 days and began to feel much better. Then it became very painful again and that is the current situation.
81 2021-02-07 pain in extremity, weakness Dizzy; Headache; Joint pain; Fever; Injection site swelling; heartbeat would accelerate for a few se... Read more
Dizzy; Headache; Joint pain; Fever; Injection site swelling; heartbeat would accelerate for a few seconds; Chills; off balance; throwing up; she could not drive and was half delirious; I am not feeling good; sneezing; has no energy; her bowel movement was little dab and then again another little dab; if she does not blow her nose, it feels like something is going down the back of her throat; She still has a punchy feeling; she does not have her peripheral vision right; Her arm felt like a boil where they gave her the shot.; Her arm is still is sore; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982, Expiry Date of Pfizer covid vaccine: May2021), intramuscular injection in left shoulder on 21Jan2021 13:00 at single dose as preventative, since she did not want to get COVID again/there was a new strain of COVID that was easier to catch. Medical history included ongoing high blood pressure diagnosed about 5 to 7 years ago, ongoing high cholesterol diagnosed about 5 to 7 years ago, thyroid disorder, Supplementation, for bones, COVID-19 from Nov2020 to Dec2020: She had COVID in Nov2020 till the end of Dec2020, and she was getting better. Concomitant medication included ongoing metoprolol tartrate for high blood pressure, ongoing simvastatin for cholesterol, ongoing levothyroxine for thyroid, ongoing colecalciferol (VITAMIN D) as Supplementation, for bones. The patient experienced chills, off balance, dizzy, headache, joint pain, fever, injection site swelling, heartbeat would accelerate for a few seconds on 21Jan2021, throwing up in Jan2021. The patient spent that whole night getting up and down and going to bathroom for bowel movement, and her bowel movement was little dab and then again another little dab. She was throwing up by 3am or 4am that night, she threw up twice and reports it was like bubbles. Her side effects started Thursday night. She experienced chills, joint pain, fever, injection site swelling, her heartbeat every so often would accelerate for a few seconds. She dizzy and off balance when she would get up to go the bathroom. Since then she still had sneezing and she was blowing her nose, and if she did not blow her nose, it felt like something was going down the back of her throat. She wanted to ask how long she would experience the side effects and how many people had a problem with the first dose. She still had a punchy feeling, had no energy. She could lay down and fall asleep at almost anytime. Height: about 5'2'', she jokingly stated she was shrinking monthly. Her chills started Thursday night and by Saturday morning they were completely gone. When she tried to turn a corner and reported she did not have her peripheral vision right since she kept running into door frames. She was a little better, sometimes she could walk a straight line and sometimes she veers. Headache was ongoing. She did not have it today, it was not a severe headache, it was more irritating than severe. Her arm felt like a boil where they gave her the shot. Her fever went away Saturday night or Sunday morning. She felt like she was not in her own mind, like she was drifting, so time lines for side effects are hard to recall. Her arm was still was sore. Heartbeat would accelerate for a few seconds was occasionally still happening, it happened last night. She called the hospital (facility where it was received) back the next morning and she was told she could come if she wanted to but it was suggested to stay home and sleep it off. She told them she could not drive and was half delirious, she was told she could call an ambulance to come get her. She confirms she did not call ambulance or go to the hospital. When querying indication, she was told there was a new strain of COVID that was easier to catch. The outcome of events chills was recovered on 23Jan2021, vomiting was recovered on 22Jan2021, joint pain was recovered on 24Jan2021, fever recovered in Jan2021. The outcome of events balance impaired NOS, dizzy, vaccination site swelling, Peripheral vision defective was recovering. The outcome of event headache, sneezing, feeling of total lack of energy, feeling abnormal, sleep excessive and pain in arm was not recovered. The outcome of rest events was unknown.
81 2021-02-07 pain in extremity my right foot swelled up and turned bright red. It was incredibly painful. I couldn't walk. It laste... Read more
my right foot swelled up and turned bright red. It was incredibly painful. I couldn't walk. It lasted 2 days and then receded. I took 5 Tylenol for the pain in 48 hours.
81 2021-02-08 pain in extremity About 2:00 PM noticed swelling and discomfort in the left shoulder and was tired. Went to sleep. T... Read more
About 2:00 PM noticed swelling and discomfort in the left shoulder and was tired. Went to sleep. The symptoms went on for the next couple of days but resolved by Thursday. the arm was stiff and quite sore, felt a little swollen. The fatigue was gone by Wednesday. Had the typical shortness of breath from her asthma. Did not take anything other than her usual Tylenol.
81 2021-02-08 tingling Within 15-minutes of vaccination, the patient reported that their "arm was getting tight and tinglin... Read more
Within 15-minutes of vaccination, the patient reported that their "arm was getting tight and tingling". EMS evaluated patient on-site. Patient was hypertensive (160/86), but otherwise vitals were WNL. Patient refused transport to hospital.
81 2021-02-09 tremor, involuntary muscle movements, feeling cold her equilibrium was off; She said feels cold all the time now; bone and muscle in her body hurt; han... Read more
her equilibrium was off; She said feels cold all the time now; bone and muscle in her body hurt; hands and body were jerking; she ached all over; she felt tired; rigors; shaking; muscle and joint aches/her muscles hurt; muscle and joint aches/her joints hurt; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3247), via an unspecified route of administration at left upper arm on 21Jan2021 08:00 at single dose for covid-19 immunization. Medical history included lymphoma from 2018. The patient's concomitant medications were not reported. There were no additional vaccines administered on same date of the Pfizer. The patient previously took rituxan for lymphoma (Reported she had been in remission for a little over a year. She said she had received only 4 Rituxan infusions for the lymphoma before she went into remission). 12 hours post injection: she "experienced significant rigors and shaking, muscle and joint aches, her equilibrium was off at some point, she was tired, had generalized pain, and chills". She also confirmed feeling better. She stated she heard the the second dose of the vaccine caused more reaction than the first dose and would like to validate the information. She explained the first instance she experienced rigors was after a lymphoma treatment. She believed the rigors lasted "12 hours" but was not certain because she "fell asleep and got warmed". The patient felt great all day on 21Jan2021 after receiving her first COVID-19 Vaccine dose. She said almost exactly 12 hours later, she started to have rigors. She was shaking so hard that her hands and body were jerking. Her muscles and joints were hurting, her equilibrium was off, she ached all over, she had pain, felt tired, and she had chills. The rigors started first. She said she felt really cold at the same time, so she went to bed and covered up, trying to get warmed. She fell asleep for awhile, and then woke up and went to the bathroom. When she went to get out of bed to go to the bathroom, she stood up, and every bone and muscle in her body hurt. She said she was aching all over, and her equilibrium was off. She didn't feel like getting up, and finally went to sleep to get the rigors to stop. She felt cold all the time now, but the rest of her symptoms had improved. She said it seemed like the muscle in her right leg was still pretty sore. She said she recovered from the rigors completely. She had rigors once before when she had an infusion. She clarified the infusion was Rituxan. She said she had a reaction to her first treatment of Rituxan. She said she had rigors when the Rituxan infusion was first started. She was given a couple things (but she didn't know what those things were), and she stopped shaking. She said the infusion staff waited a few minutes and tried to restart the Rituxan infusion, but she would have rigors again. She said the infusion staff tried slowing down the Rituxan infusion rate, as well. She said the Rituxan infusion normally takes 2 hours, but after 8 hours, she had only got about 20% of the Rituxan infusion, before the Rituxan infusion was stopped. She stated she had 3 subsequent Rituxan infusions at later dates, and did not have any problems with those infusions. Her first dose of the COVID-19 Vaccine was administered high up in the muscle of her left arm, close to the shoulder joint. She said the COVID- 19 Vaccine injection didn't hurt, and her left arm never got sore. She said on 30Dec2020 she had lab work done for her oncologist. She went about every other month for blood work to make sure she was still in remission. She saw her oncologist on 06Jan2021, and her oncologist said her blood work looked pretty good and was better. She asked her oncologist about the COVID-19 Vaccine, and her oncologist said she definitely wanted her to get the COVID-19 Vaccine. Her next appointment with her oncologist was in Mar2021. She said she had been seeing her oncologist every month, but her oncologist this time, wanted to try seeing her after 2 months. The events did not require a visit to emergency room or physician office. The outcome of events rigors, shaking was recovered in Jan2021. The outcome of events muscle and joint aches/her muscles hurt, equilibrium was off, aching all over, tired, bone and muscle in her body hurt, hands and body were jerking was recovering. The outcome of event feels cold was not recovered.
81 2021-02-09 unresponsive to stimuli, seizure PFIZER-BIONTECH COVID-19 VACCINE EUA. Vaccination occurred between 6:30am to 10am. Adverse event n... Read more
PFIZER-BIONTECH COVID-19 VACCINE EUA. Vaccination occurred between 6:30am to 10am. Adverse event noted at 5:30pm included seizure activity followed by lethargy/unresponsiveness lasting a few minutes (approx 15 min unresponsive). VS 138/82, 76,16. Blood sugar 105. O2 sat 98% on room air. MD visited and ordered labs. Subsequently treated for UTI with Rocephin IM x 5days.
81 2021-02-10 pain in extremity Awakened at about 1:00 A.M with painful arm. Pain has continued until now. Also chills and naus... Read more
Awakened at about 1:00 A.M with painful arm. Pain has continued until now. Also chills and nausea. Fever reached 100, subsequently dropping to 98.
81 2021-02-11 bell's palsy, facial paralysis Left sided Facial droop effecting Left eye and Left face muscles, concern of Stroke ambulance to H... Read more
Left sided Facial droop effecting Left eye and Left face muscles, concern of Stroke ambulance to Hospital Emergency Examined neurlogicaly Cat Scan done neg, Glucose normal REPORT BY DR "BASED ON MY ASSESSMENT AND RESULTS OFEXAMS< LABS< IMAGING IT WAS DETERMINED TO LIKELY BE BELLS PALSY MEDICAtions ordered VALTREX 3 times a day for 7 days, PREDNISONE 60mgs for 7 days EYE GTTS for Dry eye relief 3-4 times a day
81 2021-02-11 seizure, seizure Systemic: Seizure-Mild
81 2021-02-12 feeling cold Patient reported "my head feels chilly inside".
81 2021-02-12 tremor Approximately 75 minutes after vaccine had significant shortness of breath, extreme fatigue (difficu... Read more
Approximately 75 minutes after vaccine had significant shortness of breath, extreme fatigue (difficulty walking to the bathroom). Over the next week and a half, blood pressure and heart rate swung widely (outside of normal range). Heart rate periodically dropped down into 30-40 range. Experienced whiteouts.
81 2021-02-14 bell's palsy Bells Palsey Right side of face.
81 2021-02-14 flushing Systemic: Allergic: Rash Generalized-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Other- exa... Read more
Systemic: Allergic: Rash Generalized-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Other- exasperation of post-viral rash-Mild
81 2021-02-14 nerve pain, burning sensation Developed blisters/rash on left buttock on Jan 31, 2021. I also felt extremely fatigued and had chil... Read more
Developed blisters/rash on left buttock on Jan 31, 2021. I also felt extremely fatigued and had chills. I went to an appointment with a gynecologist for an unrelated chronic issue . (inflamed hemorrhoids) She examined my rash at that time and diagnosed it as shingles. Since that appointment the blisters began drying up. I continue to have itching, burning, and nerve pain on my left buttock.
81 2021-02-14 pain in extremity chills; fever; aching arms; This is a spontaneous report from a contactable consumer (patient). An 8... Read more
chills; fever; aching arms; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EK 4176) via an unspecified route of administration on the left arm on 22Jan2021 12:00 at a single dose for COVID-19 immunization. Medical history included allergies, high blood and cholesterol; and diagnosed with COVID-19 (prior to vaccination). The patient's concomitant medications were not reported. On 23Jan2021, the patient experienced chills, fever and aching arms. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown.
81 2021-02-15 weakness Severe dizziness, nausea, weakness, racing heart
81 2021-02-17 weakness Platelets dropped significantly after taking the shot. Prior to the shot my platelets were 241.; Ext... Read more
Platelets dropped significantly after taking the shot. Prior to the shot my platelets were 241.; Extreme fatigue; weakness; dizziness; heart racing; nose bleeds; unable to walk or stand up without assistance; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biontech; lot number: unknown; lot unknown reason: true received at hospital & not sure what batch they gave her) via an unspecified route of administration at right arm on 16Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient was not pregnant. Facility type vaccine was at hospital. Adverse events were reported as follows: platelets dropped significantly after taking the shot. Prior to the shot her platelets were 241. Extreme fatigue, weakness, dizziness, heart racing, nose bleeds, and also was unable to walk or stand up without assistance - overall poor health. Condition intensified to severe 1-3 days after the shot and she went to the (Hospital Name) ER on 26Jan2021. She was admitted to the hospital. During that stay her platelets dropped to 142 first day there then 126 when she was released from the hospital. A week later she went to (Name) MD for a planned office visit & my platelets were tested again and her platelets how now dropped to 89. A week after this she went back to (Name) MD and her platelets dropped again and this time now 47. Prior to the shot she have no history of low platelets or this type of unusual she'll feeling. The adverse event start date was reported as on 24Jan2021. AE resulted in emergency room/department or urgent care, hospitalization for 4 days. It was unknown if treatment received for events. The outcome of events was not recovered. No covid prior vaccination. Covid test type post vaccination included Nasal Swab on 26Jan2021: negative. Information on the lot/batch number has been requested.
81 2021-02-17 feeling hot 10 minutes following vaccination, patient complained of dizziness and feeling warm. Vitals showed e... Read more
10 minutes following vaccination, patient complained of dizziness and feeling warm. Vitals showed elevated blood pressure 193/78, normal pulse, oxygenation, and temperature. She noted mild improvement in symptoms after 30 minutes, but patient was still unsteady to ambulate independently. BP remained elevated 189/73, 191/86. She denied headaches, SOB, chest tightness, difficulty breathing, GI symptoms, rash. Patient noted history of intermittent elevated BP with systolic measurement in 250s, but no diagnosis of hypertension or hypertensive medications. She reported feeling well this morning and having normal breakfast prior to appt. Ambulance transport was called due to hypertension and persistent dizziness. Patient refused transport upon arrival and was taken by personal driver.
81 2021-02-17 nerve injury, pain in extremity, weakness Very dizzy/ Light headed; I felt very washed out and thought I was tired/ exhausted; Lethargic; She ... Read more
Very dizzy/ Light headed; I felt very washed out and thought I was tired/ exhausted; Lethargic; She still has a little weakness; Almost like a flare up of Hashimoto; a scalp problem, but nobody knows what it is/ Whatever she has, the vaccine aggravated it 10 times worse; a scalp problem, but nobody knows what it is/ Whatever she has, the vaccine aggravated it 10 times worse; she was feeling bad; The injection site was red, hard, kind of warm; The injection site was red, hard, kind of warm; The injection site was red, hard, kind of warm; joint pain, knees, feet, even my hands; joint pain, knees, feet, even my hands; It felt like some kind of nerve ending issue; She was also very off balance; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration at left arm on 23Jan2021at a single dose for COVID-19 immunization. Medical history included ongoing Hashimoto's disease; scalp issue; abrasions on her head like eczema; and weight loss. She was diagnosed a couple of years ago with Hashimoto. A thyroid disorder. She is not on a thyroid medication. They have just been watching it to see. She took the shot. For background, the last couple of months the patient has had abrasions on her head like eczema. She has been going to the Dermatologist for the last year. They have been trying to figure out what is going on. Concomitant medications included Phentermine for weight loss. The patient took the shot on a Saturday 23Jan2021. She did fine Sunday, but by Sunday evening on 24Jan2021, she was feeling bad. On 24Jan2021, the patient experienced injection site really red, hard and warm but didn't hurt; head broken out so bad; and joint pain. On 25Jan2021, the patient felt very dizzy/ light headed, fatigue and lethargic. As the evening went on for two to three days later from the vaccination, she experienced side effects. She got up in the middle of the night that night, and her head was broken out so bad that she couldn't comb her hair. There were least 100-150 small little bumps on her head. They almost feel like they have oil under them. They were sore and very irritated. Her scalp was blood red with inflammation. This has went on the course of 8-9 days. She also had joint pain really bad. Almost like a flare up of Hashimoto. She hasn't been having issues with it. It was like her skin was on fire. Even regular water in the shower feels like it was burning. It felt like some kind of nerve ending issue. She was also very off balance, and light headed. She never ran a fever. She was so exhausted that she couldn't get out of bed for the last 8 days. She is scheduled for the second shot. She is scheduled for the second dose 16Feb2021. Her doctor told her to go ahead and get the other shot, but she would like more information. She did not have a prescribing doctor. She got the vaccine at a a local hospital where she goes for testing. She could never get through to get ahold of the hospital so she tried to go through another facility. She finally got an appointment through the hospital. She was wondering if it is okay to get the second shot. She has had a scalp problem, but nobody knows what it is. They have tried to treat it with a steroid. She has seen several who don't have a clue what is could be. Whatever she has, the vaccine aggravated it 10 times worse. The joint pain was almost 100 % better since yesterday. It was mostly in her feet and knees. She was very dizzy and light headed. She wasn't falling all over the place or anything. That has improved over the last day or two. The first night, she got up to go to the bathroom, and she lost her balance but caught self. she was very careful from then on. She has fatigue as well. She still has a little weakness since the 25Jan2021. She never lost her appetite, but she felt very lethargic since the 25Jan2021. She has recovered from most of these issues, except for her head. She is in very good health except for her thyroid issue. That she has been diagnosed with for a couple of years, and the stuff in her hair. They don't know what has caused that. Every test has been negative. She thought at one point it could be the medication she was on. She was taking Phentermine to lose weight. She was wondering if it would have any recourse, but her doctor said no. She quit taking it the day before the shot just in case. She hadn't taken it again until today. The dose is 37.5mg. The way she felt at first, she felt like she had COVID. The patient stated, "I had some reaction to the (first) Pfizer covid 19 shot I took on 23Jan2021 wanted to ask if I would be able to take the 2nd shot. I took the shot fine, got home. The injection site was red, hard, kind of warm. My arm was never sore but the day after into Sunday I felt very washed out and thought I was tired. I have a thyroid issue, I've been having a scalp problem and this sometimes come with my thyroid issue. Little bumps in my scalp, they were kind of under control because of the Clobetasol propriate foam that I put in my hair and ever since then my skin is on fire. But the main thing I was exhausted, joint pain, knees, feet, even my hands. I laid around and for 5-6 days and today is the first real good day. I still have the bumps but I'm seeing a different dermatologist. I have an over active immune system Hashimoto's disease and something can set up a flare." The outcome of the events almost like a flare up of hashimoto and a scalp problem, but nobody knows what it is/ whatever she has, the vaccine aggravated it 10 times worse was not recovered; events she was feeling bad, joint pain, knees, feet, even my hands, very dizzy/ light headed, i felt very washed out and thought i was tired/ exhausted, lethargic and she still has a little weakness was recovering; events the injection site was red, hard, kind of warm was recovered in Jan2021; and outcome of the other events was unknown.
81 2021-02-17 tremor my head and ears closed down; my head and ears closed down; she doesn't sleep all night long; her bo... Read more
my head and ears closed down; my head and ears closed down; she doesn't sleep all night long; her body was shaking; my heart was beating out of my chest; felt a little lazy and tired; tinge-y pains in her heart; SVT; shortness of breath; This is a spontaneous report from a contactable consumer (patient). An 81-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261, Expiry date: 31May2021), via an unspecified route of administration on 19Jan2021 at Single Dose (dose unknown; by injection once to left upper arm) for covid-19 immunisation, levothyroxine sodium (SYNTHROID), orally from an unspecified date to an unspecified date at 0.75 mg once a day, and orally from an unspecified date to an unspecified date at 0.88 mg, once a day for thyroid disorder. Medical history included cancer, heart stents, irregular high blood pressure, breathing problem, underactive thyroid, back problem. The patient's concomitant medications were not reported. The patient took a flu shot 20 years ago for immunization and got really sick, took Pneumonia shots for immunization and was fine. On 19Jan2021, the patient had a little lazy and tired. On 21Jan2021, her heart was beating out of her chest, like she had a drum going off; beating so fast and rapid it, and her head felt closed off and ears- she could feel heartbeats in her head; on 21Jan2021, her body was shaking. In Jan2021, she had a couple tinge-y pains in her heart and shortness of breath; she had SVG, she thought, it was irregular heartbeats coming from the top of her heart. Details were as follows: On 22Jan2021, she woke up in the morning around 3-4 am and said "my heart was beating out of my chest and my head and ears closed down." The sensation subsided by 8 am. She called her family MD who did not respond so the following Monday she was in contact with her cardiologist who put her on a Holter monitor for a few days. He later told her she had SVT and prescribed a beta blocker for her to take. The patient stated "I am so allergic to medicine." She took Plavix after a stent 5 years ago and was fine taking it for a few years. Then she had another stent placed, was prescribed Plavix again, and was "so sick and dizzy and short of breath - it was the Plavix." States that she can take Cipro, ibuprofen, and synthroid and that her list of allergies is about "2 pages long." The patient wanted to know if she should take the second dose? her cardiologist advised that she not take it. Caller states she doesn't want to take the second dose and probably won't. She had a long history of allergic reactions to medications. She never had the flu, she hasn't had mumps, chicken pox, measles, occasionally, rarely a cold, about 20 years ago, she took a flu vaccine and got so sick after the shot and never took it again, she never got the flu, she does take Pneumonia shots and was fine. States she seems to have a natural immunity against typical disease you can catch. Other things, she had cancer, heart stents, and things of that sort, as far as infectious diseases, she had no problems. She had a reaction she thinks came from the COVID shot. She had a blood test and it showed her thyroid went a bit more underactive, so about 2 weeks ago, her Synthroid was raised from 0.75mg to 0.88mg, so 0.88mg was a new medication, but it was minimal. Communication: Caller was advised to slow down to assure accurate documentation. Synthroid 0.75mg: no NDC, lot, expiry. States this has been her only change in meds recently. She got that Synthroid the same day as she got her COVID vaccination, which was 19Jan2021, that afternoon, she got a Pfizer COVID vaccination. Also she got a prescription for her new Synthroid. The first day, 19Jan2012, she had no reaction at all, she took two Tylenol, someone suggested. She felt a little lazy and tired, for the rest of Tuesday, then Wednesday she felt more tired, she laid around on the couch watching TV, she stayed in her pajamas, had no serious reaction, just tired, then Tuesday and Wednesday, and then on Thursday night, she never did anything on Thursday either, she went to grocery store, was not feeling better, and on Thursday, 21Jan2021, at 3AM, she was awakened from sleeping, she did not sleep all night long, she got up often, her heart, she never had this before and had 3 stents, her heart was beating out of her chest, like she had a drum going off, it was beating so fast and rapid and her head felt closed off and ears- she could feel heartbeats in her head, and this went on, she didn't want to call, she lives by herself on a farm, and thought to wait and see if it goes away, and about 7AM, it was basically really bad from 3AM to 5AM, and at 7AM it went away, the rapid heartbeat was so far throughout and her body was shaking, and chest was so she never had it happen before. At 8AM she called her family doctor office, she wanted to go and see them and she was told she wasn't in that day, they would send a note in the computer to get back with her. The doctor did not get back with her all day Friday, and then she felt ok Friday, Saturday, and Sunday, she had a couple tinge-y pains in her heart and shortness of breath, but her heart didn't feel like it was beating out of rhythm. Then Monday morning she called her heart doctor, he said he doesn't know, it doesn't sound to him like it was the Synthroid, since it was a small change of dose, but he didn't know about COVID but he hadn't heard it as being an after effect, but he said to come by 2:30PM on Monday, to be fitted with a heart monitor, which she wears on her heart and it listens 24/7, listens to her heart function, so she wore that, he said to bring it back on Monday and leave it in the office, and she did that, she wore it Friday, Saturday, Sunday, and Monday, she never had that really huge feeling in her in heart anymore, she thought it was a waste of time, then she got a call from the heart doctor on Tuesday, he asked how she was feeling, she said she was fine, and sorry if she caused a commotion and he said she has a heart problem now, she said she didn't feel anything, but her heart is beating erratically, and he doesn't know why she didn't feel it, he said she has SVG, she thinks, it is irregular heartbeats coming from the top of her heart and he says he will send in a prescription to the pharmacy to get a beta blocker, she thinks Metoprolol. The pharmacy just got the medicine in and she is sitting there waiting now. He told her a couple months ago, her heart sounds fine, there seemed to be nothing the matter. She asked if it was the COVID vaccine, he said he doesn't know, and she asked if she should take the second dose on 09Feb2021, he said no, he doesn't think he wants her to take it, she is going to see him in 2 weeks and will try the medicine, but she wanted to report what happened to her. Has Pfizer heard of anyone having rapid heartbeat after COVID vaccination. States she is overweight. Second dose is scheduled for 09Feb2021, at 1PM. Caller states going from 0.75mg to 0.88mg on Synthroid is a minimal adjustment, it can go up to the 200's for underactive thyroid, it's minimum, she is supposed to take it on an empty stomach, first thing in the morning with water. She has had underactive thyroid since she was 20 years old, so for 40 years, and had no problems with Synthroid before. The patient had irregular high blood pressure: it is high during the night and normal during the day, and if she would take, she had been going to physical therapy, she had a back problem, it came from a different thing, her knee is bone on bone, and they want her to get a knee implant, but when she limps on her knee it makes her back, it hurts from not walking straight, so she went to physical therapy, and what was causing high blood pressure, if she took Ibuprofen or Aleve, it would significantly increase her blood pressure, so she has a sensitivity to pain medicine, especially Ibuprofen and Advil, it increases her blood pressure, and often when she doesn't have it in her system, her blood pressure is much more normal. She does not have Ibuprofen, Aleve, Advil to provide lot/expiry, she is in her car. She is interested, she feels she won't take the second vaccine, she wants to see what they say, she also wants to ask how much protection with just the first shot? The action taken in response to the event for levothyroxine sodium was unknown. The outcome of the events heart was 'beating out of chest', 'head and ears closed down' was recovered in Jan2021, of other events was unknown.
81 2021-02-18 bell's palsy Severe L-sided Bell's Palsy, onset 2/15/2021. . Per CDC recommendations we are reporting this to V... Read more
Severe L-sided Bell's Palsy, onset 2/15/2021. . Per CDC recommendations we are reporting this to VAERS.
81 2021-02-20 weakness Pt began feeling poorly, low energy after 24 hours. Increasingly short of breath, not really commu... Read more
Pt began feeling poorly, low energy after 24 hours. Increasingly short of breath, not really communicating clearly, enough that I (her daughter recommended that the Dr come. He sent for the paramedics due to low oxygen and something not being quite right. AT hospital multiple tests were run and bacterial pulmonary pneumonia along with heart failure exacerbation was diagnosis. She had been in her room for 2 weeks prior, with no contact with the outside world.
81 2021-02-21 flushing Patient became flush and light headed after her 2nd shot of Pfizer. Patients BP was 140/78 and conti... Read more
Patient became flush and light headed after her 2nd shot of Pfizer. Patients BP was 140/78 and continued to rise to 170/80, pulse dropped from 78 to 62, patient developed facial redness and after 90 minutes of observation she became to feel a lump in her throat. No difficulty breathing or respiratory issues.
81 2021-02-21 pain in extremity COVID 19 Pfizer - 2nd dose, 2/16/2021 Lot number - EL9261 - About 48 hours later, I got this pain ... Read more
COVID 19 Pfizer - 2nd dose, 2/16/2021 Lot number - EL9261 - About 48 hours later, I got this pain breastbone. I couldn't turn over to the left or right when down because of the pain. It was not shortness of breath. It was pretty bad. This pain lasted about 3 weeks. Soreness is my arm appeared the day of vaccination but that went away within 2 days. I also kept sneezing non stop, and my nose was runny this also started about 48 hours after vaccination. It is better but not completely gone yet. The sneezing is not constant, as of today but still there.
81 2021-02-21 seizure, speech disorder, impaired body coordination Received 1st dose Feb 3 @ 7am. Felt minor soreness for 2 days. Felt fine afterwards. Feb 12 devel... Read more
Received 1st dose Feb 3 @ 7am. Felt minor soreness for 2 days. Felt fine afterwards. Feb 12 developed flu like symptoms, headache mild fever, tiredness. Symptoms progressed Sat & Sun. Monday she was speaking with her brother who said she wasnt making sense. Called ambulance & brought her to hospital. Ran CT scan, multiple MRIs and did spinal tap. Diagnosed with HSE enciphilitis. Has had multiple seizures. Very confused, can barely speak, doesnt recognize or understand who people are. Troubling motor skills.
81 2021-02-23 feeling hot check her own self with her hand and it was like she put her hand on a stove; Allergic reaction; fel... Read more
check her own self with her hand and it was like she put her hand on a stove; Allergic reaction; felt bad after taking the first dose-flu like symptoms /achy like flu symptoms; had high fever/feverish; urine became yellowish-brown; had a little diarrhea symptoms; get sick; vomiting; has a really bitter taste, or no taste in her mouth/ her mouth still has that nasty, old bitter taste that does not go away with brushed teeth; has a really bitter taste, or no taste in her mouth/ her mouth still has that nasty, old bitter taste that does not go away with brushed teeth; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program Pfizer First Connect. An 81-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; manufacturer reported as Pfizer-Wyeth; lot number: EL1283; expiration date: unknown), via an unspecified route of administration left arm on 21Jan2021 12:30 at 0.3 mL, single dose for covid-19 immunization. Medical history included arthritis in back; always had diarrhea because she had cancer and is unable to control her bowels. They tell her she has a lot of fiber in her food; but she can't control it; if she eats vegetables then she knows what's happening; but she always tries to take Imodium A-D before eating vegetables. She mentioned to them if she did not eat vegetables all she could eat is meat and cheese; doctor told her she was borderline diabetic, so she has wanted to keep up with that. The doctor was not worried about it; ongoing acid reflux; pain; and ongoing high blood pressure. Concomitant medication included ongoing omeprazole for acid reflux, ongoing amlodipine for high blood pressure, naproxen for arthritis in back, caffeine, codeine phosphate, paracetamol (ACETAMINOPHEN WITH CODEINE) for pain, loperamide hydrochloride (IMODIUM A-D) for diarrhea. The patient has not received any other vaccinations within four weeks prior to the first administration of the covid-19 vaccine. Vaccinations reported as she has gotten flu shots and pneumonia shot and has never had any adverse events, reactions or problems with those; nothing. The reporter mentioned that she got her first dose of the vaccine in a clinic on 21Jan2021 and aware that the second dose will be on 16Feb2021. The patient reported that she felt bad after taking the first dose-flu like symptoms on 23Jan2021 at 8:00 and had high fever Saturday (23Jan2021), urine became yellowish-brown and wants to know more information. The patient guesses she is having an allergic reaction on 23Jan2021 at 8:00 and asked for further information about the allergic reaction relative to the vaccine. On Saturday (23Jan2021), she was feeling good. She got up, went to store, came back and had little diarrhea symptoms then she began to get sick, feverish. She added that then the vomiting, then achy like flu symptoms. She still feels feverish, she has a really bitter taste, or no taste in her mouth really but it's going away. To her it seems like the worst part is over. She almost called 911 but then did not want to go the hospital because of all the people with COVID in the hospital. The next day on 24Jan2021, when she woke up, she was not as fevered. She can check her own self with her hand and it was like she put her hand on a stove. She went to sleep and the next morning (24Jan2021), she was not as feverish; her mouth still has that nasty, old bitter taste that does not go away with brushed teeth. She feels better today (unspecified date). She mentioned that the second dose is scheduled to be administered 16Feb2021, but she really does not want to go get that if she feels like this. She had blood work for her sugar done on 21Jan2021 because she is borderline diabetic, but results are unknown, have not had any results yet. The outcome of the events was recovering.
81 2021-02-23 numbness, pain in extremity, tingling muscle and joint pain; wanting to faint/dizziness; blurry eyes; sweating; unable to sleep the whole ... Read more
muscle and joint pain; wanting to faint/dizziness; blurry eyes; sweating; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side/she was having pain on her wrist/joint pain; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side; swelling in her hand and was hardly able to bend her fingers; swelling in her hand and was hardly able to bend her fingers; wrist was swollen; itchiness, numbness and tingling in her fingers on the right side; itchiness, numbness and tingling in her fingers on the right side; itchiness, numbness and tingling in her fingers on the right side; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN5318), via an unspecified route of administration on 06Feb2021 15:00 at single dose at left arm for covid-19 immunisation. Medical history included wrist had arthritis (pain). There were no concomitant medications. Patient height was a little less than 5. She used to be over 5 but she shrunk. Her weight used to be at 226 lbs, it came up to 230. This year (2021) it went up because, its her, she ate too much and she did not obey the rules. Patient received Pfizer vaccine on 06Feb2021 afternoon at 300 pm in her left arm and that night developed itchiness, numbness and tingling in her fingers on the right side. Last night (07Feb2021) she unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side. she also reported swelling in her hand and was hardly able to bend her fingers. She tried to bend her fingers and she can but her wrist was swollen, it was less right now but she still had the pain. She applied muscle relaxant (unclear if topical) and took paracetamol (TYLENOL) and massaged her hand with warm water and then for the second time she used the muscle relaxation. She hadn't taken paracetamol yet she was waiting 4 hours but the pain was still there, it was a little bit less. Not sure if it her arthritis or side effects from vaccine but believes it was from the vaccine. Stated she used to have the same problem with her wrist arthritis (pain). Also reported that she experienced additional side effects on 08Feb2021 which lasted about 5 minutes then went away: blurry eyes; wanting to faint; dizziness, sweating (whole body started to be like sweaty). Asking for information on muscle and joint pain after the vaccine and recommendations on what to do. So far she didn't know what it was, and if it was a side effect of the arthritis, because once in a while that happens but when it happened it went away right away but this time her wrist pain was there still there. Patient sat down and now she was stretching her leg, she sat down on the chair and its gone she had no more problems. Patient said her right hand, she was very slow writing. She said at least she can write her hand was going back to a routine but she was in a lot of pain. Outcome of event wanting to faint/dizziness, blurry eyes, sweating was recovered on 08Feb2021, and outcome of other events was unknown.
81 2021-02-24 seizure Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: A... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Seizure-Severe, Additional Details: The incident happened at COVID clinic. Patient was recieving the 2nd dose of the vaccine. The first time we administered the vaccine to the patient, she informed the immunizer that she had a bad cough for 3 days. The patient did mention that she suffers from seizures often. The 2nd dose was administerd by the RPH immunizer and was directed to the waiting area for 15 minutes. During that time in the waiting area, she was talking to the.
81 2021-02-25 hot flush RECIEVED SHOT ON THE 22., FELT FINE THAT DAY. NEXT DAY TOWARD EVENING I FELT UNWELL, NO APPETITE. R... Read more
RECIEVED SHOT ON THE 22., FELT FINE THAT DAY. NEXT DAY TOWARD EVENING I FELT UNWELL, NO APPETITE. RESTED HAD A LITTLE CEREAL BEFORE I WENT TO BED. TOKE SOME TYLENOL, SLEPT WELL, FELT GREAT NEXT DAY AND AGAIN LATE AFTERNOON FELT SICKLY, MY LEFT JAW FELT SORE, NOTICED WHEN I WANTED TO EAT IT HURT TO OPEN MY JAW, VERY PAINFUL WHEN I NEEDED TO JAWN, WAS HUNGRY AND TRIED TO EAT A BANANA WHICH I WAS ABLE TO EAT BY LIKE SCRAPING THE FRUIT WITH MY TEETH. SINCE THEN THE PAIN LESSENED TODDAY I STILL HAVE PAIN WHEN I OPEN MY MOUTH WIDE, I FEEL IT IS GETTING BETTER DAILY AND SINCE I HAVE ONLY THE OTHER SIDEEFECT OF HAVING NOW AND THEN HOTFLASHES , I THINK I WILL BE FINE AGAIN IN A COUPLE OF DAYS.
81 2021-02-25 night sweats, pain in extremity woke up in the middle of the night sweating; whole left shoulder, arm and hand was very sore and ach... Read more
woke up in the middle of the night sweating; whole left shoulder, arm and hand was very sore and achy; whole left shoulder, arm and hand was very sore and achy; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 21Jan2021 at a single dose on the right arm to be inoculated against the virus. The patient has no medical history and there were no concomitant medications. The patient reported that she got the Pfizer vaccine shot last Thursday, 22Jan2021 and while she was there she didn't have any reaction. She had the vaccine in her right arm because she was left handed and by the time she got home, her whole left shoulder, arm and hand was very sore and achy. She had trouble with her left shoulder, she didn't know if it was the co-incident (as reported) or not and then it kind of then the patient took some Tylenol and it kind of eased up. The patient then reported that on 22Jan2021, Friday night, she woke up in the middle of the night sweating and that happened during the night and in the morning it went, but it is still there but she still has soreness in her left shoulder, arm and hand and it kept her up last night. She didn't know if this was going to be a symptom of the vaccine. She wanted to know that when she will get the second one, is it going to be worst and what she was supposed to do. The patient was scheduled to get the second dose on 11Feb2021. The patient reported unspecified labs with unknown results. The outcome of the events whole left shoulder, arm and hand was very sore and achy was not recovered while the outcome of woke up in the middle of the night sweating was unknown. Information on the lot/batch number has been requested.
81 2021-02-25 tingling, numbness, tremor Patient received second dose of Pfizer vaccine. Both patient and her daughter went to the car to wai... Read more
Patient received second dose of Pfizer vaccine. Both patient and her daughter went to the car to wait. Was approached by security as daughter returned to the center stating her mother was having a reaction. I went to the car & assessed patient. Patient c/o numbness/tingling along the left side of her face and head. Significant tremors and shortness of breath noted at the time. Daughter went and secured wheelchair & we brought the patient back into the vaccine clinic. VS at 1340: BP: 164/65, PO2: 88% on 3L, HR: 60 Patient reported anxiety prior to coming in for vaccine. VS at 1347: BP: 184/82, PO2: 94% on 3L, HR: 60. Patient states numbness/tingling increasing; reporting circumoral tingling/numbness. 25mg Benadryl given. VS at 1355: BP: 233/102, PO2: 92% on 3L, HR: 60 Discussed with Pharmacist. EMTs called for transport to ED per patient's request. Observed in ED and d/c home with no further treatment in stable condition.
81 2021-02-26 weakness Fever to 100.6 with weakness and fatigue on day #11 after 2nd vaccine given. Symptoms resolved withi... Read more
Fever to 100.6 with weakness and fatigue on day #11 after 2nd vaccine given. Symptoms resolved within 24 hours.
81 2021-02-26 pain in extremity Patient called the pharmacy stating that she had a fever (101 F), diarrhea, and a sore arm after rec... Read more
Patient called the pharmacy stating that she had a fever (101 F), diarrhea, and a sore arm after receiving her second Pfizer COVID-19 vaccine on 2/26/21
81 2021-02-28 weakness SQUESSING SENSATON IN HEAD AND DIZZY WHEN MOVED HEAD SLIGHTLY' . DIAHREA STOMACH ACH AND SLEPT HOUR... Read more
SQUESSING SENSATON IN HEAD AND DIZZY WHEN MOVED HEAD SLIGHTLY' . DIAHREA STOMACH ACH AND SLEPT HOURS AND HOURS AND WEAK.
81 2021-02-28 pain in extremity weight was 236-238 and bounces back and forth; Started getting real dizzy that comes and goes/ if sh... Read more
weight was 236-238 and bounces back and forth; Started getting real dizzy that comes and goes/ if she moves too fast that the dizziness comes and goes; Right arm is sore and not tender; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249 expiration date: May2021, via an unspecified route of administration on 26Jan2021 at a single dose in the right arm for COVID-19 immunization. Medical history included heart problem from Nov2019 and ongoing and angina pectoris. Concomitant medication included a lot of pills for her heart problem. She was on blood thinners, sugar pills, and uric acid because of the diuretics. The patient stated that she got her shot yesterday (26Jan2021) a little after 1. Later this morning (27Jan2021), that she started getting real dizzy that comes and goes. She was reading the list and dizziness was one of more serious side effects. She wanted to know what to do about it, it was one of things. She has another shot coming up on 16Jan (as reported). The patient further mentioned that her right arm was sore and not tender on 27Jan2021. If she moves too fast that the dizziness comes and goes. Her weight was 236-238 and bounces back and forth because she was on diuretics. The outcome of the events dizziness was not recovered, right arm was sore was recovering while for weight was 236-238 and bounces back and forth was unknown.
81 2021-03-01 hot flush, feeling cold, unresponsive to stimuli, cold sweat, cold sweat, flushing, unresponsive to stimuli Completed 15 min observation; as exiting felt flush, and hot wanted to sit; sat down and slumped ove... Read more
Completed 15 min observation; as exiting felt flush, and hot wanted to sit; sat down and slumped over; Daughter called help; No Bp or O2 measurable; felt cool and clammy to touch; chest rises with breathing; eyes open and blinking but not responding to questions asked; performed sternal rub, did not react; Rapid response notified;Connected to monitor; aganol respiration noted,Transferred to stretcher. lips turned purple; bag mask placed and bagged respirations; approx 15 chest compressions performed, responded to compressions; Started to breath and color returned to face. Immediate transfer to ED.
81 2021-03-02 muscle spasms, fibromyalgia muscle spasms; bad fibromyalgia; runny nose; This is a spontaneous report from a contactable consume... Read more
muscle spasms; bad fibromyalgia; runny nose; This is a spontaneous report from a contactable consumer (patient). This 81-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 (at the age of 81 years old), for COVID-19 immunisation. Medical history included highly allergic to some medications and bleeding disorder (she was on a blood thinner). Concomitant medications were not reported. On an unspecified date the patient experienced muscle spasms and spent 3 days at the hospital. She had to go again on an unspecified date in Feb2021, she got a lot of illnesses, she was also on a blood thinner and was highly allergic to some medications. Since an unspecified date she had really bad fibromyalgia. All these symptoms were usual for the patient, other than the runny nose. She needed to get a hold of her doctor, she had a follow up like right now. She wasn't supposed to go (for her appointment) until the 23Feb2021. She was scheduled for the second vaccine dose on 08Feb2021, however she was in the hospital and was wondering if it was too late. Events outcome was unknown. Information on the lot/batch number has been requested.
81 2021-03-03 muscle spasms, discomfort, pain in extremity 3/02 As the vaccine was given in my left arm, I felt it travel down inside my arm and toward my hand... Read more
3/02 As the vaccine was given in my left arm, I felt it travel down inside my arm and toward my hand. i waited at Pharmacy for 20 minutes with no reaction. I returned home and within the hour I began to feel "very tired' and lay down in my bed. Within minutes, my left thump had spasms and painful cramping and "froze" I massaged my thump for about 5 minutes and the pain subsided. I then had painful cramping in my left calf and then the entire leg which then followed by Muscle pain and cramping in both legs. I was told that I should exercise, so I went for a long walk. When I returned home, i felt even worse so I went back to bed. Headaches began. I had flu-like symptoms (chills and discomfort) I covered my self with two blankets and drank lots of water and took an Aleve.which upset my stomach. 3/03 (the next morning), my usual sinus stuffiness was Gone! and I could breathe better than i have in a long time (by days end my sinusitis had returned) and so had my headache. Today 3/04 I still feel exhausted and I have swelling, puffs under my eyes (not usual) and occasional headaches. My Left Arm (area of the inoculation) Has Never Been Painful!!!!!!
81 2021-03-04 discomfort She is experiencing an Allergic reaction, rash; little coughing spell; Itching eyes/My eyes started ... Read more
She is experiencing an Allergic reaction, rash; little coughing spell; Itching eyes/My eyes started itching; Multiple hives all around her right eye; Wheezing; didn't feel comfortable; her upper lip became puffy/bottom lip began to swell; This is a spontaneous report from a contactable nurse (patient) via Medical Information Team. An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6201), intramuscular at upper left arm on 21Feb2021 at 08:30 at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccination within 4 weeks. The patient had no additional vaccines administered on same date of bnt162b2. Medical history included seasonal asthma, allergy to class A antihistamines that started in her 20s, facial & peripheral edema, blood pressure abnormal, and celiac disease. The patient had known allergy to Benadryl and when she takes it she gets peripheral and facial edema, lip swelling, top and bottom, hives around her whole right eye. The patient also has an allergy to Class A antihistamines that started in her 20s. She said the allergy started with Seldane & Claritin. She said she had giant hives with Claritin. She said she was told there were 2 classes of antihistamines & she couldn't use the Class A antihistamines. She said she previously reported her Seldane, Claritin & Benadryl allergies, saying she has facial & peripheral edema. She said she only uses the Class B antihistamine Cimetidine now. Concomitant medications included metoprolol, omeprazole, and pravastatin. On an unspecified date, the patient was experiencing an allergic reaction, rash. On 21Feb2021, the patient experienced "her upper lip became puffy/bottom lip began to swell," multiple hives all around her right eye, wheezing, and didn't feel comfortable. On 21Feb2021 at 14:00 (reported as about 2PM), the patient experienced "Itching eyes/My eyes started itching." On 21Feb2021 at 21:00 (reported as 9PM), the patient experienced little coughing spell. The reporter considered the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing as serious medically significant. The patient further reported that she felt fine after the shot, her arm was not sore, nothing. She said her arm was fine, and she had no problems, whatsoever, after receiving the COVID-19 Vaccine. She said she has had some weird allergic reactions in the past, but no anaphylaxis. About 12:00 to 12:30 PM (also reported as around midday), the patient's lip felt puffy. She said she had ate an apple and thought maybe something was on the skin of the apple. She said then her bottom lip began to swell, so she took 3 Cimetidine (NDC Number: 49035-820-72, lot number: 9AE2576A, expiry date: Dec2020). The patient stated that she was allergic to what she believe are class A antihistamines as they gave her facial and peripheral edema including Benadryl and everything on the list. About 2PM, the patient's eyes felt itchy, she took allergy eye drops (eye drops seasonal relief with tetrahydrozoline HCL 0.05% and zinc sulfate 0.25%. She said the product packaging reads it soothes eyes, and she said the eye drops worked. Lot number: AC8K275, expiration date: Sep2021). She said when she looked in the mirror, she saw a large hive on her eye (clarified as multiple hives all around her right eye). And about 4PM, she realized that her lips felt puffy, so she repeated the Cimetidine, it kept them from getting worse. At 7PM, her eye felt worse. She had this real hive that surrounded her right eye, she took a picture so she could report it to the doctor. The patient have an appointment on Wednesday. At 7:30PM, the patient's lips were puffy, she repeated the Cimetidine again and took of the 200 mg, she takes 3 at a time, she mentioned she could take 4, but she takes 3. She said she took more Cimetidine at 8:30PM, and talked to a pharmacist, who told her to call Pfizer to report her reaction. She said she attempted to call Pfizer last night, but it was too late, clarifying Pfizer Medical Information was already closed for the day. The patient also reported that she had a little coughing spell at about 9PM, so she stayed up with her husband till 10PM because she didn't feel comfortable. The patient told her husband to wake her up every once in a while. The patient felt a little wheezy, she used both of her inhalers, she could hear the wheezing, she used the serevent diskus (Serevent Diskus 50 mcg Inhaler. She said she has been using the Serevent Diskus Inhaler for seasonal allergies for years and the inhaler works. She said she occasionally uses the Serevent Diskus for colds during the winter. She said she realized she was wheezing last night and thought she should use the Serevent Diskus. NDC Number: 0173-0521-00, Lot Number: VV3E, Expiration Date: Sep2021) and Flovent (Flovent HFA 110mcg Inhaler, NDC Number: 0170719-20, Lot Number: C47A, Expiration Date: Jul2021). That seemed to be okay, she went to bed, and had a good night no problems. She said she woke up this morning and felt better. She said she sounds a little gunky this morning, clarifying that was somewhat typical for her. The patient further reported that she got up at 6:30AM, she took a shower, she was having a rebound reaction, and wheezing, so she took 3 more Cimetidine and repeated the inhalers. She clarified while her symptoms worsened after the hot shower this morning, her symptoms are much less than yesterday (21Feb2021), saying she was aware of her symptoms today, and paying attention to them. She said her lips became puffy, and she was wheezy after the hot shower. She said she took Cimetidine and her inhalers again this morning to treat the rebound reaction. She decided to repeat again at about quarter to 10AM, she repeated again trying to keep it under control. In the meantime, she spoke to her doctors office, and they just said keep doing what she's doing, and if she get real bad, call 911 or go to emergency room (ER). The patient have an appointment, the patient's big concern was that she probably shouldn't get the second COVID shot. She read on (website), that there was a very rare, mild anaphylactic reactions. What caught her eye was that this takes place about 4 hours after the dose. This was when her symptoms began, lucky her. Her whole life has been allergy related. The patient don't know if celiac disease has anything with this. The patient wanted to know whether or not there was some way to take the shot without killing herself. She said she was not having breathing difficulty, she was just wheezy. She said she repeated the Cimetidine about a half hour before she called Pfizer today. She said she called her doctor's office this morning, and her doctor said for her to keep treating her symptoms as she had been doing. She said her doctor told her to call an ambulance or go to the emergency room if her symptoms happen to get worse. She said she read online that skin anaphylaxis (hives, itching, and swelling of the eyes, face, lips and throat) can occur with the COVID-19 Vaccine. She clarified she read the information about the COVID-19 Vaccine at (Website name). She said she read skin anaphylaxis was extremely rare and less than 1% of the population has the allergy, and those individuals should not get the COVID-19 Vaccine. She said she was upset because what she read probably means she can't get the second COVID-19 Vaccine shot. She said she read the skin anaphylaxis appears within 4 hours after getting vaccinated with the COVID-19 Vaccine. She said her symptoms occurred in almost the same amount of time as to what she read about a skin anaphylaxis reaction to the COVID-19 Vaccine. She said she has a regular check-up on Wednesday (24Feb2021) with her doctor, and will speak further to her doctor about getting the second COVID-19 Vaccine. The reporter considered the events lip felt puffy, eyes started itching, hives, and wheezing as serious medically significant. The patient had no emergency visit. The patient had no relevant tests done. Therapeutic measures were taken as a result of the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing. The patient had not yet recovered from the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing while outcome of the events rash, little coughing spell, and didn't feel comfortable was unknown. The reporter considered the events swelling lips, itching eyes, hives, and wheezing as related to bnt162b2.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
81 2021-03-06 pain in extremity Got intense pain in upper thigh, right leg, so bad I could barely walk. Had to told onto walls. We... Read more
Got intense pain in upper thigh, right leg, so bad I could barely walk. Had to told onto walls. Went on all night. Next morning I also had bad, but not AS bad, pain in upper left thigh, closer to groin. It went away completely by 2pm on 3/5. Had made with apptmt with my PCP for getting bloodwork and xrays. When pain was mysteriously gone, I canceled. But pain was incredibly intense on 3/3 and into morning.
81 2021-03-10 inability to speak Approximately 5 hours after vaccine, she started experiencing slight confusion. By morning she was ... Read more
Approximately 5 hours after vaccine, she started experiencing slight confusion. By morning she was completely confused, didn't know where she was, didn't know her daughter, was trying to take her medication by chewing them, couldn't speak, etc. BP extremely elevated. CT and labs all negative. Admitted to hospital. By the next morning she was more clear, but is still somewhat confused and still has memory loss.
81 2021-03-10 pain in extremity No side effects in 30 minute waiting period and none on day of injection--some mild itching began ni... Read more
No side effects in 30 minute waiting period and none on day of injection--some mild itching began night of injection. Day after, Saturday, itching intensified, throat tightened (muscular feeling); and tongue began to become sore, and began to show redness on sides. Bad enough that I finally took a 4-6 hour dose of Benadryl, and slept afternoon. Felt better when I woke up but when effects of Benadryl wore off, the tongue swelling intensified and frightened me. Decided against emergency call on weekend and took Benadryl (4-6 hour) about 8 or 9 Pm and next morning (about 5 or 6AM) noted that I felt okay and tongue had become pink not red though still some swelling on the sides of tongue. Had no strong adverse effects after first dose, some chills in the evening and arm swelling/pain that resolved by 3AM.
81 2021-03-13 pain in extremity Right upper arm intense pain . 45 minutes later I laid down in bed and it was like explosions in my... Read more
Right upper arm intense pain . 45 minutes later I laid down in bed and it was like explosions in my upper body, torso and arms. Intense pow-pow, - pow pow pow on and on for an hour Intense in my left arm but continued constantly for about an hour. When it subsided I got intense chills radiating up and down my legs,. That stopped and I had regular chills throughout my body. Started to have a headache. Went to sleep after some time, and when I awoke the next morning, I had such fatigue, I could hardly get out of bed. I spent the next two days sleeping most of the day. I did not eat because I just wanted to sleep.
81 2021-03-14 pain in extremity feeling shaky/she is nervous about the palpitations.; soreness and swelling at the injection site; s... Read more
feeling shaky/she is nervous about the palpitations.; soreness and swelling at the injection site; soreness and swelling at the injection site; she experienced palpitations when she went to bed; her arm was sore; maybe she was dehydrated; This is a spontaneous report from a contactable consumer (patient). A 81-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) , lot EL9269, expiration date 20May2021, via an unspecified route of administration on 05Feb2021 (at the age of 81 years old) as a SINGLE DOSE in the right arm for covid-19 immunisation. Medical history included ongoing High Blood Pressure Diagnosed about 35 years ago (1986) and ongoing Diabetes Type 2 Diagnosed about 20 years ago (2001). Concomitant medication included oral nifedipine from Sep2020 and ongoing at 30 mg, 1x/day for High Blood Pressure, ubidecarenone (COQ-10), bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), acetylsalicylic acid (BABY ASPIRIN) one every other day. Historical vaccine information included BNT162B2 on 15Jan2021, Lot number EL8982, Expiry 20May2021 first dose via injection into the left arm for COVID-19 immunisation at 81 years old. She had no reaction at all to the first dose. The patient's arm was sore the day of the vaccine on 05Feb2021. On 08Feb2021, she experienced palpitations when she went to bed. She got into bed and was trying to fall asleep, she started to get palpitations.She sat up and walked around, and took a acetaminophen (TYLENOL) and water, because she was thinking that maybe she was dehydrated in Feb2021 or something, and it seemed to go away, and she did fall asleep and she slept for several hours, very well. Then, around 7am this morning, the palpitations started a little again, but not as bad as last night. She had breakfast and then was okay again. Then she sat down in front of her computer, and the palpitations started again. The palpitations are not constant, they come and go. On 09Feb2021, the patient experienced feeling shaky but states this might be because she is nervous about the palpitations. On 09Feb2021, she experienced soreness and swelling at the injection site. Treatment for palpitations was acetaminophen (TYLENOL). Outcome of her arm was sore, feeling shaky/she is nervous about the palpitations, soreness and swelling at the injection site and maybe she was dehydrated was unknown. Outcome of palpitations was not recovered
81 2021-03-14 pain in extremity headaches/her head hurt; fever; threw up; pain across her shoulder; top of my arm swollen and then i... Read more
headaches/her head hurt; fever; threw up; pain across her shoulder; top of my arm swollen and then it ran straight to my back; suffering pain; arm was real sore /pain in the left arm/her arm felt like it was going to fall off; sick as a dog; She was very upset; nausea; her back still hurts to move/it ran all way over to my back; didn't feel like eating; sneeze; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 26Jan2021 (at the age of 81-year-old) as a single dose for COVID-19 immunisation. The patient medical history and family medical history. prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she was administered with the first dose of the vaccine on 26Jan2021, and she has been feeling sick as a dog since she got it. The patient wanted to know about the ingredients used in the formulation of the Pfizer's COVID-19 vaccine. It was reported that patient had been suffering pain on 26Jan2021. The patient took pain pills for the pain. On 26Jan2021, the patient arm was real sore, her arm felt like it was going to fall off/pain in the left arm and on 27Jan2021, the patient experienced hurting in her head/ headaches. The patient reported that she would not have taken the vaccine if she had known her arm would hurt like that. On 27Jan2021, she started having sharp pain across her shoulders, through her shoulder blade to the middle of the back . She tried a heat pad, ice packs and the pain just keep shooting and she believes she had a fever with it. She threw up. She was very upset with all of this and mentions that her husband had passed away. It was reported that patient took pain medication referring to Robaxin 500mg and it didn't work. She also took Methocarbamol 500mg and it helped a little but not a lot. Adds she called the paramedics. The paramedics examined her and told her they had been to the Navy hospital several times and it was very crowded and they advised her to take Tylenol. She took the Tylenol 325mg and she went to sleep but when she woke up she still had the real sharp pains. She thinks the Tylenol helped some. She also took Ibuprofen via oral route at a dose of 400mg as needed per the instruction of the paramedics at. Mentions her symptoms were improved but her back still hurts to move on an unknown date in 2021. She has not eaten except to take medicine. She didn't feel like eating on an unknown date in 2021. She was scheduled to receive the second dose on 16Feb2021 but wanted to refuse because she heard it is even worse than the first time. The patient reported that she experienced sneeze on an unknown date in 2021. The patient reported ‘top of my arm swollen and then it ran straight to my back and I cannot get no relief on 26Jan2021; I really get sick with pain I mean with pain, it ran all way over to my back (as reported). It was reported that Pain is so bad; I have been in pain; I have been laying, it's hurt me so bad (as reported). The patient also experienced nausea on an unknown date in 2021. The patient was suggested to rest until feel fine. The patient called the ambulance but they (staff) confirmed no need of emergency room and want the patient to rest until she was fine. They told her not to get up and she don't want to get up either. Therapeutic measures were taken for suffering pain, pain across her shoulder, headaches/her head hurt, her back still hurts to move/it ran all way over to my back, top of my arm swollen/her arm was real sore and pain in the lefts arm/her arm felt like it was going to fall off. The patient did not receive any treatment for the events. The events were reported as non-serious by the reporter. The outcome of the events pain, sick as a dog, nausea, her back still hurts to move/it ran all way over to my back, didn't feel like eating, sneeze, she was very upset, arm was real sore /pain in the left arm/her arm felt like it was going to fall off was unknown while for other events was recovering.
81 2021-03-15 weakness tired; rash from shoulder to elbow; Eyes heavy; feels under the weather; low energy level; slept for... Read more
tired; rash from shoulder to elbow; Eyes heavy; feels under the weather; low energy level; slept for 3 days; This 81- year-old female patient contactable consumer received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EL9262), via an unspecified route of administration, on 28Jan2021 at 11:30 (at the age of 81-years-old) as a single dose for COVID-19 immunization, left arm in the muscle. The facility where COVID-19 vaccine was administered was at a clinic. Historical Vaccine included first dose of BNT162B2 on 07Jan2021 (lot EI3246), for COVID-19 immunization, left arm at the same site between 11:30-12:00. The patient's concomitant medications included medications for years for thyroid and cholesterol. The medical history included: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Allergic to Sulfa, years ago and she got a rash. States she is very healthy. She has had no other vaccines in the past 4 weeks. She stated she has had a low energy level, heavy eyes (31Jan2021) and has been tired for nearly two weeks now. She still feels under the weather (31Jan2021). She had a rash from shoulder to elbow (31Jan2021) and was sleeping for 3 days(28Jan2021) without getting up much. For 3 days she was out and it got better, but she would go to bed (as reported) and back to bed. She is usually a very active person. Like yesterday, she had to go out. She is not one to fuss over anything. She went out and today, is a bit better. She is getting better every day. The outcome of the events low energy level and tired was unknown; rash, slept for 3 days, Eyes heavy, and feels under the weather was recovering.
81 2021-03-15 numbness, pain in extremity, tingling Left arm was sore for 24 hours after injection. Ten days later the left arm became sore again. There... Read more
Left arm was sore for 24 hours after injection. Ten days later the left arm became sore again. There was tingling in my lower face. Each day since February 10, there has been some degree of numb/tingling feeling in my lower face. There have been numb/tingling feelings in my left arm and hand, but also at times in both legs, and occasionally in my right arm. This has been going on for several weeks now.
81 2021-03-16 involuntary muscle movements, pain in extremity Chills; Involuntary jerking; Chest pounding; left arm was pulsating; chest and arm are now sore; che... Read more
Chills; Involuntary jerking; Chest pounding; left arm was pulsating; chest and arm are now sore; chest and arm are now sore; Headache; This is a spontaneous report from a contactable consumer (reporting for herself). An 81-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269, expiration date: unknown), via an unspecified route of administration, administered in right arm on 11Feb2021 at 09:56 as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (lot number: EL1283, expiration date: unknown) on 21Jan2021 for COVID-19 immunization. On 11Feb2021, the patient stated getting a little headache and went to bed. On 12Feb2021, the patient got chills, stated that she started involuntary jerking that she could not control, her chest was pounding and her left arm was pulsating, going in and out. The patient also stated that her chest and arm were sore and it was pounding so hard. The patient was ready to go to the emergency room at 1:30 AM but did not. The patient was encouraged to reach out to her healthcare provider. The outcome of the event chills, involuntary jerking was recovered on 12Feb2021, chest pounding, left arm was pulsating was not recovered and unknown for the other events.
81 2021-03-16 pain in extremity Patient received 2nd dose on 3/1 and self-reported experiencing fever and lethargy for 3 days. Two d... Read more
Patient received 2nd dose on 3/1 and self-reported experiencing fever and lethargy for 3 days. Two days post dose, patient complained of her left leg hurting to her daughter. Daughter inspected leg and did not notice any swelling or warmth. Two days after that symptom started (4 days post dose), patient's leg felt better but she now had shortness of breath which she claims worsened for two weeks before presenting to the hospital where patient was diagnosed with a pulmonary embolism.
81 2021-03-17 feeling cold Flu, chill, unsteady, and have 3 red hives on left arm.
81 2021-03-17 pain in extremity Pt states she received vaccine around 10am. States "it ached going in and then was ok until noon". R... Read more
Pt states she received vaccine around 10am. States "it ached going in and then was ok until noon". Reports she took Ibuprofen with no effect. States left arm "ached" and rated pain 8/10 at that point. Reports she took a 45 minute nap and after waking, could not lift her arm. Reports "by supper she could not grip, arm felt weak". Reports took APAP at supper and before bed with no effect. Reports she could "not cover herself up in bed nor dress herself before bed". States she woke up in the middle of the night to use the restroom and could not pull up her pants herself. Was then not able to go back to sleep due to the pain. Reports she then took an Excedrin (around 3am) and by noon she could move her arm "about
81 2021-03-18 weakness Systemic: Diarrhea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details:... Read more
Systemic: Diarrhea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Admitted to ER on 3/15/21 released on 3/16/21. Experienced extreme vertigo, vomiting, and diarrhea. Still a little weak today (3-18-21).
81 2021-03-18 pain in extremity sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 81-years-old... Read more
sore arm; This is a spontaneous report from a contactable consumer (patient herself). A 81-years-old female patient started to receive bnt162b2 (BNT162B2) (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection)via an unspecified route of administration from 03Feb2021 to 03Feb2021 at SINGLE DOSE for covid-19 immunisation .Medical history included thrombosis from Feb2020 to an unknown date Verbatim: blood clots. Concomitant medication included varicella zoster vaccine rge (cho) (SHINGRIX), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient previously took eliquis for thrombosis. The patient experienced sore arm on 03Feb2021 and The patient underwent lab tests and procedures which included investigation was unknown results and Consumer calling about Pfizer COVID-19 vaccine who says she just had a question since she had the first dose of the vaccine yesterday. She says that the first dose went fine, and she had no ill effects at all other than a sore arm, but she didn't know that Ibuprofen shouldn't be taken before getting the vaccine and she takes low dose Aspirin every day. She says yesterday she took her dose of Aspirin, and she doesn't know should if she should continue to take her low dose Aspirin. and Caller took a low dose aspirin before taking the first dose. She is asking if that is okay. .
81 2021-03-20 weakness Extreme weakness, redness, itching, "funny feeling all over"
81 2021-03-20 tremor Headache, heaviness in head. I was able to concentrate and do my work but head felt heavy and clou... Read more
Headache, heaviness in head. I was able to concentrate and do my work but head felt heavy and cloudy (?) when standing. Was okay when doing work a my desk. An extreme and unusual fatigue. Some occasional weakness in legs especially when getting up. Some interior shaking. It happened 4-5 times over 10 days. Did not last more that 30 seconds to 1 minute. Had absolutely no symptoms after vaccine. Symptoms started about 4-5 days after vaccine.
81 2021-03-28 burning sensation, night sweats, tremor Frequent arrhythmias; 20 point systolic BP rise; sense of oppression in breathing; vertigo on arisin... Read more
Frequent arrhythmias; 20 point systolic BP rise; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue; audible pulse in ears; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6200), via an unspecified route of administration administered in left arm on 19Feb2021 18:00 (at the age of 81-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The reported facility type was a hospital. No other vaccine in four weeks. The patient did not have covid prior vaccination and was not covid tested post vaccination. Medical history included Hashimotos Thyroiditis, irritable bowel syndrome (IBS), food and seasonal allergies, allergies Iodine isotope contrast, latex, cows milk protein. Concomitant medications included levothyroxine sodium (SYNTHROID); amlodipine and spironolactone. The patient previously took paracetamol (TYLENOL) and thiomersal and experienced allergies from these drugs. The patient experienced frequent arrhythmias day after; several days of 20 point systolic BP rise; audible pulse in ears; sense of danger; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue all on 20Feb2021 at 13:00. After 20 days (in Mar2021), all has abated but muscle weakness and fatigue. Unwilling to risk the booster. There was no treatment for the events. The outcome of the events muscular weakness and fatigue was not recovered while for the remaining events was recovered with sequelae in Mar2021.
81 2021-03-30 pain in extremity Polyarthritis affecting hands, wrists, shoulders, knees - significant pain and inability to ambulate... Read more
Polyarthritis affecting hands, wrists, shoulders, knees - significant pain and inability to ambulate without significant pain; behaves like reactive arthritis/autoimmune disease, intermittent fever, CRP markedly elevated at 133 (normal < 10); requiring Prednisone for treatment; unresolved as of 3/3/1/21
81 2021-03-30 pain in extremity inflammation/inflammation on her right side of waist and in the back down in to pelvis, ovary and g... Read more
inflammation/inflammation on her right side of waist and in the back down in to pelvis, ovary and groin area; pain in her arm; muscle pain; pain; Her arm bothered her: she could not lift her arm; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Left Arm on 29Jan2021 (Batch/Lot Number: EL9262) as single dose for covid-19 immunisation (Indication: Felt that getting COVID at her age would be worse than getting a possible reaction to the vaccine). Patient had an allergic reaction to the swine flu vaccine in 1979-1980. Patient had muscular problems that resulted from the Swine Flu shot. She had weakened muscle. Most of the time she was okay, but she was more prone to getting back pain and stuff, not pain on her side and on the front side like she has now. Patient wanted to know if the swine flu shot and the covid 19 vaccine had similar ingredients. The Swine Flu shot was back in 1979 or 1980. This is the only type of flu vaccination she has ever had. She did not take more after that. She does not have a lot number to provide. She does know though, that a lot of people at that time came down with (Name) from that vaccine. With this vaccine, nobody seems to be getting strong side effects from it. No Other Products. Patient History reported as No. No Investigation Assessment. The patient medical history and concomitant medications were not reported. The patient experienced pain in her arm statin she could not raise her arm for a day. Her arm bothered her: she could not lift her arm on 30Jan2021and recovered on 31Jan2021. The patient experienced a day later pain and inflammation on her right side of waist and in the back down in to pelvis, ovary and groin area muscle with not recovered (reported as worsened). Caller stated that it was quite painful describing the pain as muscle pain and inflammation. Caller stated that this pain had not gone away. Caller stated she was due for her second dose and wanted to know if she should get the second dose based on her side effects to the first dose. The patient was having to take anti-inflammatory medications for the pain associated with her side effects to the covid 19 vaccine. Patient thought she had a reaction to the Pfizer COVID Vaccine. The day after she had the usual side effect of her arm bothering her. Then she started to experience pain and inflammation around her right side from the waist area down to the front of her pelvis to her groin muscle. It seems like pain and inflammation. It has not gone away. If patient stays home and did nothing she felt a little better. If she took an anti inflammatory she also felt a little better. If she was going out and doing something it flares up. That was why she felt it was muscular, it felt inflamed. Caller stated that it overall had gotten worse in the last few days. She was doing more things than the first couple of days. Treatment: The anti inflammatory was Diclofenac 25mg. She had also been taking Tylenol at night. She said that it does not make the pain completely go away, but it helps keep the pain tolerable. Did not have either of these medications on hand to provide the lot numbers. The outcome of event Her arm bothered her: she could not lift her arm was recovered on 31Jan2021, of other events was not recovered.
81 2021-03-31 facial paralysis, face paralysis, inability to speak Right facial droop weakness aphasis
81 2021-04-02 pain in extremity mucous membranes inside her nose were burning; headache; soreness in the arm; inside of cheeks were ... Read more
mucous membranes inside her nose were burning; headache; soreness in the arm; inside of cheeks were puffy; random itchiness; increased fatigue; Irritation roof of mouth; tongue was raw, red, and puffy; This is a spontaneous report from a contactable consumer or other non hcp. An 81-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration, in Arm Left on 04Feb2021 13:00 as SINGLE DOSE for COVID-19 immunization. Medical history included restless legs syndrome, multiple allergies, disability (handicapped for 7 years), osteoarthritis, drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took ampicillin and experienced rash, ampicillin and experienced drug hypersensitivity. After 1.5 hours after vaccination, the patient experienced headache, random itchiness, increased fatigue, irritation roof of mouth, tongue was raw, red, and puffy on 04Feb2021, mucous membranes inside her nose were burning, on 05Feb2021. The patient stated some side effects including: the inside of her cheek became puffy, the roof of her mouth became irritated, her tongue became raw and puffy and red, the mucous membranes became irritated, and she had burning inside her nostrils. The roof of her mouth and inside of cheeks is diminished but it is not gone and has been 6 days. The caller stated she has multiple allergies and chemical sensitivities and asked if this is a common side effect in sensitive people. She stated she has not taken any allergy medicine. The caller stated she also had a headache that lasted the rest of the day, soreness in the arm, random itchiness that began an hour and half after and continued to next day then began to disappear, intense fatigue for 3 days, her restless leg was increased through yesterday, for several days she felt out of sorts, didn't feel like herself, she can't put her finger on it but she felt off, she had increased joint and muscle pain a day and a half later, and has heard that whatever side effects you experience they will be more intense after the second dose. The patient stated that the facility didn't give them a vaccine card, NDC/LOT/EXP: Unknown. She says that they gave her some copied pages and a date for her next dose appointment which is 25Feb2021. She says that her first dose was injected in her left arm on 04Feb2021 at 01:00PM. She says that 1.5 hours after her first dose she had a headache and itchiness. She says that the itchiness was random and minor, and went away by the next day with no treatment. She says then she also had increased fatigue that day, which lasted for three days. She says later on Thursday, the day she got the vaccine, the inside of her cheeks were puffy, the roof of her mouth was irritated, and her tongue was raw, red, and puffy. She says she did no treatment for this, though she does have Benadryl in her house, she is so sensitive to Benadryl (UPC/LOT/EXP: Unknown) because she has restless legs syndrome, it makes it worse. Caller says she did not take the Benadryl. Caller says she is handicapped and has difficulty standing with restless legs syndrome. She says that those symptoms diminished, but have not gone, it has been 6 days already which is why she looked at the information from Pfizer. She says that the mucous membranes inside her nose on the following day were like burning, and she couldn't use her regular nasal wash that she uses. No further details provided about nasal wash. She says that was subsiding, and the thing that has been the most aggravating right now are the feelings in her mouth, which are not listed on normal side effects, which is why she called to find out if they could be side effects, and find out if it could be her immune system working. The patient stated she has had previous allergic reactions 7 years ago, when her allergist wanted to immunize her to Ampicillin allergy, which she is allergic to all major antibiotics, and when she had that she had a thick tongue and a puffy roof of her mouth and irritated tongue. She says that her allergist wrote a note saying they felt this was her immune system reacting. She says that the allergist was trying to help her with desensitization for her allergies, and she wanted to know if something like this happens with this COVID-19 vaccine, if a number of sensitive people that are sensitive to medications have reactions like this to it. She says that she thought she would call here before calling her general practitioner. Ampicillin NDC/LOT/EXP: Unknown. She says she is allergic to Ampicillin and Penicillin, she took Ampicillin 30 years ago and had a rash, and is allergic to everything else. She says that she was supposed to have elective surgery, so her doctor wanted to make sure she would be able to take an antibiotic, so her allergist chose Ampicillin. Penicillin NDC/LOT/EXP: Unknown. The patient stated she has not had any other recent vaccinations or started any new medications. She says she has eaten or drank nothing different recently. The patient stated she has so many allergies that she can't tell what they all are, she has multiple allergies and chemical sensitivities that she doesn't know what they are. She says there are inert ingredients in some medications too, she is difficult to prescribe for, as well as some things have multiple fillers but those have never been identified as to what is bothering her, so she just tries different manufacturers to see which don't bother her after she takes them. She says she is an unusual case. The patient says that she is handicapped and has had restless legs syndrome which she has had for a number of years. And handicapped 7 years, and she needs two hip replacements. She says she has end stage osteoarthritis, documented as provided. She says when her allergies and chemical sensitivities become active, with her restless legs syndrome it is difficult to stand, it makes her restless legs syndrome worse. The outcome of the event random itchiness was recovered and the outcome of all other events was unknown. Information on the lot/batch number has been requested.
81 2021-04-02 pain in extremity got really tired'; chills; diarrhea; she threw up; had swollen lymph nodes; nausea; pain in her arm;... Read more
got really tired'; chills; diarrhea; she threw up; had swollen lymph nodes; nausea; pain in her arm; This is a spontaneous report from a Pfizer-sponsored program. A 81-years-old contactable female consumer(patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. On 28jan2021, patient experienced some reactions like chills, nausea and diarrhea so was asking if she really needs to take the second dose. Follow-up information was received on 12Feb2021 from a contactable consumer reported that patient experienced pain in her arm, got really tired', chills, diarrhea, vomiting, and swollen lymph nodes for a little bit. Caller stated that her husband only experienced a sore arm. Information on the lot/batch number has been requested.
81 2021-04-03 numbness chronic muscle tension; Bladder infection; couldnt sleep; shaky; pain; numbness; This is a spontaneo... Read more
chronic muscle tension; Bladder infection; couldnt sleep; shaky; pain; numbness; This is a spontaneous report from a contactable nurse (patient). This 81-years-old female (at the time of vaccination weight; 58.97 kg, height; 160 cm) nurse reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9269) Is COVID19 vaccine a Pfizer product; Yes, COVID19 vaccine manufacturer; unspecified, NDC number, expiry date; unknown via an unspecified route of administration from 02Feb2021 at 04:00 pm to 02Feb2021 at 04:00 pm at single dose (dose number;1) on left arm for covid-19 immunisation. Identification of the country where the drug was obtained: Country of authorization/application. Vaccination Facility Type; Health facility, Vaccine Administered at a Facility; No. Patient's medical history included thyroidectomy had in 1968, blood pressure, neuropathy, back surgery, breast cancer (dates unspecified), family history relevant to AE; none. Past drug event included Aromasin for breast cancer; inflammatory response, historical vaccine included Tetanus Diphtheria; about 4 weeks before, no specific information available. Relevant Tests: Urinalysis on 09Feb2021, diagnosed with bladder infection. Specific values not provided. Concomitant medications included levothyroxine, 88mcg one time a day by mouth for she been taking this since she had thyroidectomy for thyroid, amlodipine, 5mg one time a day from 5 years or so for blood pressure. Caller received the first dose of the Pfizer covid vaccine a week ago. 24 hours after vaccination on 07Feb2021 she could not get comfortable from a lot of pain, which went on for 24-36 hours. She went to urgent care for this and the doctor made her take a urinalysis and diagnosed her with a bladder infection. She was given antibiotics for this and the symptoms have gotten a lot better. She went to the ER on 10Feb2021 and the physician diagnosed her with chronic muscle tension. Caller also added that she had an underlying neuropathy from a back surgery as well as inflammatory response to medication she took for breast cancer 20 years ago. She wanted to check if her side effects may be related to the covid vaccine. Caller needs some information, stated she had the first dose of the Pfizer vaccine a week ago today, 02Feb2021 at the (Name) (Name), states she also has some underlying conditions, like neuropathy and that sort of thing associated with a back surgery she had 3 years ago, states numbness has been increasing over time. Caller states that the first 24 hours after the vaccine were fine, night after 24 hours couldn't sleep, pain, numbness and shaky and just a train wreck on 07Feb2021. Caller states she was so uncomfortable she went to urgent care. Doctor stated the symptoms could be a urinary infection, was diagnosed bladder infection on 09Feb2021 and was prescribed Keflex for treatment. Thinking perhaps it was coincidental, has had an inflammatory response to another medication Aromasin for breast cancer treatment. States this was before, 15 years ago, does not have information to provide, no lot, expiration, or NDC number. States she is just familiar with the inflammatory thing. Caller's question is have we had any reports such as this, any inflammatory responses. The events were not considered serious. Investigation Assessment: No. Did any AE(s) require a visit to: Emergency Room; no, Physician Office; Yes, patient went to Urgent Care. If Yes, which AE(s); pain and numbness. If the patient was hospitalized, how many days was the hospital stay; Not hospitalized. The outcome of events of pain, hypoaesthesia, insomnia and nervousness was recovering while for cystitis was unknown and for muscle tightness was unknown..
81 2021-04-07 weakness, pain in extremity, burning sensation break in rash/rash in mouth and throat; sore throat; dizzy; weak; felt like sleeping all the time; p... Read more
break in rash/rash in mouth and throat; sore throat; dizzy; weak; felt like sleeping all the time; pain in her arm; blood clot in right leg; couldn't walk; veins are swollen; right knee got swollen; ear ache; felt like burning/ sore in her mouth like she was burned; sore in her mouth like she was burned; nausea; headache; slight fever; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in right arm on 09Mar2021 (Lot Number: EL9266) at single dose for covid-19 immunization. Medical history included arthritis, respiratory issues, allergies, Eczema of the nipples and breast, arthroscopic surgeries, she lost her voice. Caller stated she exercised everyday, she did yoga. Caller reported the last 2 years she hadn't been able to climb the mountain on the stairs. Caller states she didn't catch a cold, she was fine, she was very active. She was good except arthritic conditions, she has had arthroscopic surgeries, that was a side effect of that. Caller reporting she was a first responder and had some respiratory issues. Caller stated she had some allergies, if with dust or smoke, her throat constricts, it was just small, like her throat. She cannot be around that. She got once in a while, when she got in a rush. Caller stated before the vaccine, she had eczema in her nipples, on her breast. Caller stated she never got sick, besides the rash she got once in a while. Caller states but she was very healthy otherwise, no medication, no smoking, no drinking. Caller stated she was from 9/11, this was what happened with her voice once in a while, she lost her voice. Caller stated she had had some respiratory issues and allergies and so on. Caller stated she was here for 56 years and her mother died of old age so she was not sure. There were no concomitant medications. The patient previously took advil. Caller stated she used to take Advil when she went to the gym and had problems but she hasn't taken Advil for a while. She didn't take meds. Caller stated she didn't drink or smoke because what it did was it gave you a release. Caller stated she was not taking none, she was pushing through and hoping it will heal itself. The patient experienced blood clot in right leg on 26Mar2021, break in rash on an unspecified date, headache on 09Mar2021, slight fever on 09Mar2021, veins are swollen on 12Mar2021, right knee got swollen on 12Mar2021, sore throat on an unspecified date, ear ache on 10Mar2021, nausea on 09Mar2021, rash in mouth and throat on an unspecified date, felt like burning/ sore in her mouth like she was burned on 10Mar2021, sore in her mouth like she was burned on 10Mar2021, dizzy on an unspecified date, weak on an unspecified date, felt like sleeping all the time on an unspecified date, couldn't walk on 12Mar2021, pain in her arm on an unspecified date. Was a first responder, sometimes break in rash once in a while. Got Pfizer 1st vaccine 09Mar, was scared to have difficulty breathing however had headache, slight fever, right knee and veins were swollen, sore throat, ear ache, nausea, rash in mouth and throat also felt like burning also was dizzy and weak and felt like sleeping all the time. Caller stated she was told by her doctor to take the shot on 09Mar2021. Caller stated she had headache, slight fever, then her head was ok the fever was gone but the headache persisted as of today. Caller stated she still had headache and ear ache and her knee got swollen, her right knee. Caller stated for a few days she couldn't walk. Caller reported she has arthritic conditions in knees, she exercises everyday and no problem, but she couldn't walk for a few days. Caller states now she is able to walk on something, but the veins in the knee were still there and she didn't know. Caller stated she was due for second next on Tuesday and she was wondering what to do. Caller stated she was honestly worried about this reaction after the first shot. Caller stated she was told the 2nd had a worse reaction, so she was really weary and worried. Caller stated she only slept 5 hours at night, but now she wanted to sleep all the time. Caller stated she had such a headache and earache. Caller stated it made her nauseous, like in a sea or something. She stated she didn't know how to explain. She didn't vomit like when you were nauseous, it wasn't that feeling. Caller stated it was just lingering like when you were in the ocean. Caller reported headache has gotten better. It has gotten worse and then gotten better. Caller stated the earache was so painful and was still there. Caller reported she got it during the day and when she lied down, but the severity had subsided. Caller stated she didn't measure fever. She wanted to say after that, her mouth was sore after fever from the heat or from the vaccination. Caller stated her mouth was still today, still sensitive. Caller reported it was like her throat and her mouth was so sore like a burn. Caller reported her headache was mostly on the left side, but went to the right side too. Caller reported she could feel it in her eye, it hurt and her ear hurt. Caller reported her sore throat, the upper part, was still sensitive. Caller stated she couldn't swallow, but it was clear, her mouth was clear, only the upper top she would say. Caller stated it's 99% gone, its healing. Nauseous, like in a sea, its not like she has it all day long- nauseous- maybe once a day, nothing severely like what she had for a few things. The patient had a pain in her arm and she had that symptom one night and the following day she had nothing. Her arm was cooperative. Since she had been diagnosed with a blood clot. She saw her doctor on Friday and was recommended that she took some medications. She continued to have headache which she reported, though not as bad. She also reported that she had a sore mouth and earache. She was still fighting symptoms and didn't know what to do with the blood clot. She was scared to take the blood thinner Eliquis and that she will have side effects that it will do her harm she felt Eliquis will do her harm if she received the second dose of the vaccine or takes Eliquis. She was supposed to 20mg daily which she felt will kill her given her body was not healed from receiving the first dose of the Covid-19 vaccine. There was no prior vaccinations within 4 weeks. She was prescribed Eliquis Film-coated tablet (Lot Number: ABN4449S, Expiry date: Feb2023) 20mg daily for blood clot but had not started because she felt it will kill her was scared to take the second dose of the vaccine. The patient underwent lab tests and procedures which included Sonogram: blood clot in right on 26Mar2021. Therapeutic measures were taken as a result of blood clot in right leg. There was Physician Office Visit for all events. The outcome of the event blood clot in right leg, veins are swollen, right knee got swollen, couldn't walk was not recovered, of event slight fever was recovered on 10Mar2021, pain in her arm was recovered, of event ear ache, nausea, felt like burning/ sore in her mouth like she was burned, sore in her mouth like she was burned was recovering, of other events was unknown.
81 2021-04-07 pain in extremity Pain in arm; She was slightly dizzy; The initial case was missing the following minimum criteria: no... Read more
Pain in arm; She was slightly dizzy; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 11Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 81-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL8982), via an unspecified route of administration in the left arm on 10Feb2021 18:30 (at the age of 81-years-old) as single dose for covid-19 immunisation. Medical history included (caller mentions she dyslexia but this was prior to the COVID vaccine). Concomitant medication included apixaban (ELIQUIS), via an unspecified route of administration from an unspecified date (taking for 6-7 years) at unknown dose and frequency for an unknown indication. On an unspecified date the patient experienced pain in extremity and dizziness. Caller, reporting that she took the COVID shot and was told that if she is on a blood thinner she shouldn't have gotten the vaccine, is that true. She asks if we make Eliquis. The only small issue she had after the vaccine was some pain in her arm. She worked the pharmacy at one time. She got the shot on 10Feb2021 at 6:30pm. Treatment: Hot compress to the area. Caller remarks that just now when she stood up, she noticed she was slightly dizzy. Could that be caused by the vaccine. Therapeutic measures were taken as a result of pain in arm (pain in extremity). The clinical outcomes of the pain in extremity and dizziness were unknown. No follow-up attempts are possible.
81 2021-04-08 pain in extremity Feeling unwell; lower back is killing her; left leg pain; left thigh swollen/left calf swollen; feel... Read more
Feeling unwell; lower back is killing her; left leg pain; left thigh swollen/left calf swollen; feeling really bad and may go to emergency room; in lots of pain/had some pain Sunday; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, Solution for injection), via an unspecified route of administration, at dose 1 administered in Arm Right (Arm Right Upper) on 04Feb2021 15:30 to 04Feb2021 15:30 (at the time of 81-years-old) as single dose for covid-19 immunisation (due to age 81). The patient's medical history was not reported. There were no concomitant medications. She was in a lot of pain this morning. Yesterday she was fine and on Sunday she had some pain on Feb2021. Today she feels unwell and her lower back is killing her, has left leg pain, the left thigh is swollen and the calf of the left leg is swollen on 10Feb2021. Mentions she had her first Pfizer BioNTech Covid-19 vaccine last Thursday. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. Later mentions she feels really bad and might go to the emergency room. No further details provided. The outcome of events was not recovered. No follow-up attempts (needed or possible). No further information expected. Information about lot/batch number has been requested.
81 2021-04-12 weakness, tremor 3rd or 4th day after shot: Extreme fatigue, severe weakness, shakiness, especially in lower extremit... Read more
3rd or 4th day after shot: Extreme fatigue, severe weakness, shakiness, especially in lower extremities. Often trembly with complete lack of appetite (lost 6 pound in 2 weeks). Only wanted to sit or lie down- unable to go for daily walk (no strength). No fever or respiratory symptoms. This extreme condition lasted for approx. 10 weeks, during which time I saw my doctors five times for diagnosis or assistance. They could find no reason for my sudden symptoms except for adverse reaction to the vaccine, and were unable to assist. I mostly sat and laid around for 10/11 weeks , after which my symptoms improved gradually, and I am feeling better at this time.
81 2021-04-12 involuntary muscle movements, tremor Arm and legs are shaking; Jerking; Joints are painful; joint pain especially in the finger; Feeling ... Read more
Arm and legs are shaking; Jerking; Joints are painful; joint pain especially in the finger; Feeling weird; This is a spontaneous report from a contactable consumer (patient's husband). An 81-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265), via an unspecified route of administration, on 27Jan2021 at 11:45, at a single dose, for COVID-19 immunization; and rosuvastatin, via an unspecified route of administration, in Feb2021 for 3 days, at an unspecified dose and frequency, for blood cholesterol. The patient's medical history included high blood pressure. The patient's concomitant medication included ongoing amlodipine for high blood pressure. The patient's husband was calling about the COVID-19 vaccine and he is not sure if what the patient was experiencing was because of the vaccine or a prescription drug (rosuvastatin) she took but her arm and legs are shaking like jerking and joints are painful on 04Feb2021. The medication the patient's husband was referring to is rosuvastatin which the patient takes for cholesterol. The patient took this for 3 days and she started feeling weird in Feb2021, so she stopped taking. The patient's husband not sure what to do since the patient went to the doctor and the doctor did not find anything, she went to the emergency room. The patient was hospitalized for two days. The patient also saw a specialist neurologist who recommended to take more tests, but the patient is waiting for the tests. In 2021, the patient had a magnetic resonance imaging (MRI) and electroencephalography (EEG). The patient was experiencing joint pain especially in the finger at night still (the joint pain is not in the arm and legs but in her finger). This started a few days later and was still going on. It has stayed the same and some days are better and then some days are worse. The patient was admitted to the hospital in 2021 for 2 days due to events. No treatment was received for the events. The action taken in response to the events for rosuvastatin was permanently withdrawn in Feb2021. The outcome of "Feeling weird" was unknown. The patient had not recovered from "Joints are painful; joint pain especially in the finger". The patient was recovering from the remaining events.
81 2021-04-12 night sweats Woke up on 4/10 (day after administration) with bone and muscle aches, blurry vision, headache that ... Read more
Woke up on 4/10 (day after administration) with bone and muscle aches, blurry vision, headache that felt like it was in eyes on both side. Also had hot sweats during the night. Took tylenol and drank a lot of water, as advised, at vaccine facility. Treated with bed rest; All symptoms resolved on Mon 4/12
81 2021-04-13 weakness Entire clothes were drenched. Face was red. Very weak. Her left eye was closed. No appetite. Slept a... Read more
Entire clothes were drenched. Face was red. Very weak. Her left eye was closed. No appetite. Slept all day. Body was hot to touch. Lasted for 24 hours.
81 2021-04-16 speech disorder, weakness, involuntary muscle movements My mother has had Myasthsbia Gravis for 5 years and has been in stable condition. About 3 weeks aft... Read more
My mother has had Myasthsbia Gravis for 5 years and has been in stable condition. About 3 weeks after her second shot, she became very weak, had head drop, difficulty opening her mouth and talking.
81 2021-04-17 unresponsive to stimuli Shock; Reduced Central pulse volume; Loss of consciousness; potential anaphylactic reaction; found u... Read more
Shock; Reduced Central pulse volume; Loss of consciousness; potential anaphylactic reaction; found unresponsive in a swimming pool; This is a spontaneous report received from a contactable Physician. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included cardiac arrest, congestive heart failure, difficult breathing and arrhythmia. Concomitant medications included metoprolol; omeprazole; propranolol; duloxetine; fosinopril; pravastatin; hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ); levothyroxine sodium (SYNTHROID); insulin glargine (BASAGLAR); asa and ranitidine hydrochloride (ZANTAC). The patient previously minocycline for swelling and the patient had a historical vaccine of shingrix on 11May2020. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 for covid-19 immunisation. The reporter stated that the patient was found unresponsive in a swimming pool on 18Feb2021. The patient also experienced shock, reduced central pulse volume and loss of consciousness and potential anaphylactic reaction on an unspecified date. The patient did not received any recent vaccines for SARS-CoV2 other than Pfizer_BioNtech COVID-19 Vaccine prior to the event being reported. The patient died on 22Feb2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. Information on Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: found unresponsive in a swimming pool; Shock; Reduced Central pulse volume; Loss of consciousness; potential anaphylactic reaction
81 2021-04-21 facial paralysis, slurring, limb paralysis Stroke involving paralysis of right arm, right leg, slurred speech, facial droop, nausea, garbled sp... Read more
Stroke involving paralysis of right arm, right leg, slurred speech, facial droop, nausea, garbled speech
81 2021-04-23 feeling cold Nausea, cold chills, sweats, loos of appetite and memory.
81 2021-04-26 pain in extremity, speech disorder After the first vaccine she experienced pain in arm and pain between the eyes. She also had flu like... Read more
After the first vaccine she experienced pain in arm and pain between the eyes. She also had flu like symptoms for approximately 3 days, and unusual bowel movements not diarrhea, not constipated, but not normal and painful. After second dose had similar reaction bowel issues are still bad and very painful (to the point of vomiting during bowel movements due to pain). She saw her primary care doctor and was Rx'd a cream. This has caused her to decrease her eating. This did not help and she was having loss of visual acuity and started not being able to speak properly so went to the ED for concern over Strokes. had 2 MRIs, and determined not to be having a stroke so was released to home. Sxs seemed to resolve ( like a spell) . Was still having bowel issues and she also developed a rash from the neck to the groin. So she went to a specialist. The Rash cleared after about 3 days. Specialist advised that the sxs were all due to the COVID Vaccine. Flank pain under the right ribs has also been present, this is not improving, it is a dull pain that seems to be worsening ( the bowel seems to be about back to normal now) She is planning on speaking with her PCP about the right flank pain.
81 2021-04-28 seizure, muscle spasms She got the vaccine, and had no reactions at all other than perhaps a chill. About 2-3 weeks later... Read more
She got the vaccine, and had no reactions at all other than perhaps a chill. About 2-3 weeks later on 3/7/21 she started experiencing what they are calling muscle confusions. She feels a tapping sensation on her biceps and triceps and then starts with muscle cramps running down her right arm creating her fingers to cringe or come together or contract. This then travels down to her right leg to her quadriceps which cramps and convulse and travels to her calves which tighten up like a Charlie Horse and down her toes to where they contract as well. They are intermittent, scattered and sporadic. Sometimes she will get 2-3 a day, and then none at all and then a few days later a couple more. These contractions last 3-5 minutes. She had COVID back in April of 2020 and was hospitalized until August of 2020 with that. During that time she was on a ventilator for 60 days and on a breathing tube and coded and was out for about 30 minutes. She had an EEG of her brain in September and told that she was fine. her neurologist felt she should have another one due to these symptoms, and she had that and everything was normal. The doctor prescribed 500 mg twice a day of Levetiracetam. The seizures kind of regress a little and then they came back and he upped that medication to 1000 mg twice a day. The seizures still continue and have continued but is still taking the medication. He felt that she should know see an epileptic specialist and they have an APT for 5/27/21. These episodes are exhausting and wear her out. She was going to PT due to the weakness from being in the hospital for so long, and now she is fearful if she is going to fall and uses a walker and is having a setback in that progress. She is to continue therapy at home for now and to follow up with the Epilepsy specialist.
81 2021-04-30 weakness weakness in arms and legs; shortness of breath; she felt terrible; achiness; energy level is just no... Read more
weakness in arms and legs; shortness of breath; she felt terrible; achiness; energy level is just no energy; chills; could not walk across the room; This is a spontaneous report received from a contactable consumer (patient). An 81-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left shoulder upper arm from 13Mar2021 02:00 to 13Mar2021 02:30 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. No family history. No additional vaccines administered on same date. No Prior Vaccinations within 4 weeks. Patient received 1st dose of the Pfizer COVID vaccine on 13Mar2021 and experienced side effects on 31Mar2021. She mentioned that she could not walk across the room (2021) due to shortness of breath that began 31Mar2021 and was ongoing and about the same, her temperature was not high, down by 1 which would then be the onset of her chills (2021) which would come and go, just like a roller coaster, she felt terrible, had achiness, could not decide what to eat, and would feel better for 2-3 hours but felt bad right away. She mentioned that she felt just terrible and that all she wanted to do was die. Patient had whole body aching that was off and on since 31Mar2021 and not it finally diminished starting yesterday; she had weakness in her arms and legs that began not right away but on 04Apr2021 and was better; her energy level was just no energy and it started on 31Mar2021 and ran through 05Apr2021 and thank goodness the energy finally came back and she is finished now with that and feeling better since yesterday; she felt better but that only lasts 2-3 hours and she felt bad again and the chills start in again. She mentioned that she took acetaminophen and ibuprofen for the achiness, whenever needed. Patient stated she had no treatment, no visit to the HCP or emergency room and just took acetaminophen and ibuprofen and did not know when the took them but it was just in that timeframe. This morning, she had Gatorade to regain electrolytes and felt energized. As of calling, she was finally been feeling better and ally symptoms have decreased. AEs did not require a visit to ER or MD office. Outcome of shortness of breath was not recovered, outcome of achiness and weakness in arms and legs was recovering; outcome of other events was unknown. No investigation assessment. No follow-up attempts are needed. No further information expected.
81 2021-04-30 pain in extremity Sore arm, left, were the shot was from; Slightly tired; This is a spontaneous report from a contacta... Read more
Sore arm, left, were the shot was from; Slightly tired; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262) at the age of 81-years-old, via an unspecified route of administration in left arm on 20Jan2021 at single dose for COVID-19 immunization. Medical history included type 2 diabetes from 2004 and high blood pressure from 2000, which were both ongoing. Concomitant medications included unspecified medications including blood pressure medication. She has not started any new medication prior to starting or during the vaccine. There were no additional vaccines administered on the same date and within four weeks prior to the COVID-19 vaccine. The patient previously received flu shots, her last flu shot was in September. The patient received her first dose of COVID-19 vaccine on 20Jan2021 at around at 1:30 to 1:45. On 21Jan2021, the patient experienced sore left arm where the shot was administered, and she was also slightly tired. She mentioned that she experienced the events both times, she received her second dose on 10Feb2021. The outcome of the events was recovered on 22Jan2021.
81 2021-05-02 tremor, nerve pain 3/6 I woke up with a nerve pain the size of a silver dollar at top center of right thigh where it jo... Read more
3/6 I woke up with a nerve pain the size of a silver dollar at top center of right thigh where it joins my torso and i still have that pain, 3/9 under distress because of the pain I had a venous ultrasound on both legs with Dr., then I noticed on 3/13 rose pink flesh on both lower calves, 3/18 Dr sent me for an MRI Imaging of my lower back because of the pain. 3/19 I saw Neuro Dr for Botox on left side of face, I was told that they thought a nerve crossed a vein that caused a tremor on the left side of my face. 3/23 Dr. had an audio apt. 3/29 I had a full breakout of cellulitis on my lower left leg and it was a deep deep purple red and it itches. 3/30 I was sent to Dr assistant to see if I had extensive back and hip trouble and I was examined physically with movement, they offered a shot at nerve point and water therapy. I put arnicare on the spot and it makes the pain manageable. 4/7 cellulitis, 4/9 I tried to be seen, 4/10 my heart beat irregular, then the rash appear and there was acute pain at the top of my head. ValACYcalovir 500 tab (valtrex) 4/19 Sonogram for arteries in my legs and I was given the doxycycline and prednisone, and today I still have a bright red and swollen ankle on the right and I still have some dried up shingles on my chin and head. I have photos that I took of my reaction to the vaccine.
81 2021-05-03 speech disorder started to speak gibberish and was taken to the emergency room; out of it; combative; started to spe... Read more
started to speak gibberish and was taken to the emergency room; out of it; combative; started to speak gibberish and was taken to the emergency room; out of it; combative; She can't remember anything after the emergency room/She has no recollection; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 81-year-old via an unspecified route of administration, administered in the left arm on 04Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, blood pressure abnormal. There was no other vaccinations within four weeks prior to the first administration. Concomitant medications included ongoing metformin taken for diabetes mellitus; lisinopril taken for blood pressure abnormal, both taking for quite a while; at least a few years. The patient previous took first dose of BNT162B2 at the age of 81-year-old via an unspecified route of administration, administered in the left arm on an unspecified date as single dose for covid-19 immunisation. The patient experienced started to speak gibberish and was taken to the emergency room; out of it; combative on 06Mar2021. Caller stated she was perfectly fine and healthy prior and up to that time and the day after. Caller stated on Saturday she got up in the morning and was talking to a friend when all of a sudden something was going wrong. Caller thanked God she was at a friend's because if she had been home she would have died. Caller stated she was rushed to the ER and after 3 MRIs that confirmed that she was not having a stroke or something similar. Caller stated she spent 6 days in ICU and 2 weeks in a rehab center, went back to friends house for another week, before she went home because she was not comfortable being home by herself because she was to take her blood pressure often. Caller stated she was perfectly fine after the first shot and after the second one. It was 2 days and she had this terrible reaction and it was the only thing it can be put down to so everything else had come up normal. On 06Mar2021, caller explained she was actually getting ready to groom one of her dogs. She got up and felt fine and she was talking to her friend and another one of her friends and all of a sudden she started to talk gibberish, so her friend asked if she was having a stroke. Her friend took the caller's blood pressure and said they were going to the hospital and her friend took her to the emergency room. Caller stated that was all she can recall. She can't remember anything after the emergency room. According to her friend, caller was out of it, getting combative, and all kinds of stuff going on. She had no recollection, she remembered getting in the car to go to the hospital, but then had no recollection. Caller stated she just went to see the doctor a week ago and got a good bill of health. The doctor said she was pretty much good; she's improved. Caller stated her doctor told her she did not have a stroke and they did not definitively know what happened; the only thing she can put it down to was a reaction to the Pfizer COVID-19 vaccine. The outcome was recovering. Information about the Lot/batch number has been requested.
81 2021-05-04 weakness weakness; This is a spontaneous report from a contactable consumer (patient's son). An 81-year-old f... Read more
weakness; This is a spontaneous report from a contactable consumer (patient's son). An 81-year-old female patient received bnt162b2 (BNT162B2, Pfizer BioNTech COVID 19 vaccine), dose 2 via an unspecified route of administration on 27Jan2021 (Lot Number: EL1283) as single dose for covid-19 immunisation. Medical history included doesn't sleep. The patient received first dose (Lot Number: EL1284) on 06Jan2021 for covid-19 immunisation. The patient's concomitant medications were not reported. The patient had weakness on 2021. The patient underwent lab tests and procedures which included SARS-CoV-2 test was fine. The outcome was recovered. No follow-up attempts are needed. No further information is expected.
81 2021-05-04 pain in extremity Blood clot in lungs and leg; Trouble breathing/Shortness of breath, but not as bad; didn't feel righ... Read more
Blood clot in lungs and leg; Trouble breathing/Shortness of breath, but not as bad; didn't feel right; Chest tightness; Slightly ill; Sore arm, in left arm where the shot was; Slightly tired; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 10Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunization. Medical history included Type 2 Diabetes from 2004 and ongoing, High Blood Pressure from 2000 and ongoing (reporter stated she was 81; it's not very high, usually when she goes to the doctor). Concomitant medications not specified but reporter mentioned that everything she has been on she has been on long time; she takes blood pressure medication because sometimes it is high. She has not had started any new medication prior to starting vaccines or during both vaccines. The patient previously received flu shot (September). The patient received her first vaccine dose of bnt162b2 (Lot # EL9262, Expiry date UNKNOWN), on 20Jan2021, at 1:30-1:45, in the left arm and experienced sore arm and slightly tired. The reporter stated that after her second vaccine on 10Feb2021, she had a sore arm, (left, where shot was) and was slightly tired from 10Feb2021 until 12Feb2021. She confirmed she noticed this started the same day, 10Feb2021. On 31Mar2021, she felt slightly ill and had some slightly trouble breathing. She saw her doctor who did some tests. The next day 01Apr2021, her tests came back and the doctor told her to go to the hospital. While in the emergency room she had a CT of the lungs that showed blood clots in both lungs. She was admitted to the hospital where on 02Apr2021 they did a ultrasound of her legs. She was told she had blood clots in her right leg. She stated she had no symptoms of blood clots in her legs like redness, sore, swelling, or hot. She was asked if she had fallen suddenly, had an accident, or was sitting for a long time, traveled a long distances. On 02Apr2021 she had a Echocardiogram and was told her heart was ok. Caller stated she was given Lovenox shots in the hospital. She did not have Lot # or Expiry date on the Lovenox. She stated on 02Apr2021 after having two Lovenox shots that day, she met with a Vascular Surgeon who started her on Eliquis that evening. She stated she started taking Eliquis that evening. She stated she took 2 tablets, twice a day, for a week. Now she takes one tablet, twice a day, ongoing. The Eliquis tablet says 5mg. She stated she was discharged on 03Apr2021, that evening. Patient went back to the emergency room on 10Apr2021 after speaking with a nurse at (university name withheld) because she had tightness in the chest but the shortness of breath, her breathing was not as bad. She just didn't felt right. She stated she was not admitted. Patient stated she saw a NP (name withheld) with (university name withheld) Pulmonary the day of 31Mar2021. When discussing the tests performed that day, Chest X-ray, D-Dimer, and Pro INT, CH asked caller the results from them. She did not provide results, just stated she had looked up her results in "EPIC mychart" while getting the result information from the office. Where she was instructed to go to the hospital. She went to the Clinic of the Vascular Surgeon at (Hospital withheld) on Wednesday 14Apr2021 and was feeling better. Her second appointment with them will be in July. Where they will do another ultrasound of her legs and talk about the medication. She has an appointment with her primary on 19Apr2021. The outcome of events Trouble breathing (recovered on 14Apr2021), Shortness of breath, but not as bad (recovered on 12Apr2021), Sore arm, in left arm where the shot was (recovered on 12Feb2021), Slightly tired (recovered on 12Feb2021) Chest tightness (recovered on 12Apr2021), and didn't feel right was recovered. The outcome of event Blood clot in lungs and leg was unknown.
81 2021-05-06 pain in extremity Severe Muscular pain in Left upper leg (thigh) and ALL other muscles in body
81 2021-05-07 speech disorder, nerve injury 6 days following vaccine patient had blurred vision and collapsed; refused transport to hospital fro... Read more
6 days following vaccine patient had blurred vision and collapsed; refused transport to hospital from EMS; 10 days after vaccine, patient suffered what was deemed to be a TIA but actually found to be an ischemic stroke. Was speaking and was to be released to at home rehab; 1.5 days later suffered what appeared to be a stroke but brain MRI showed no change. She now has C3 nerve involvement not related to the stroke and, speech and movement issues. Cause undetermined.
81 2021-05-08 bell's palsy, face paralysis, facial paralysis 81 year-old female patient in otherwise good heath received her first dose of BNT162b2 (Pfizer-BioNT... Read more
81 year-old female patient in otherwise good heath received her first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), administered in right arm on 02/02/2021 (Lot Number EL9264) for COVID-19 immunization. Concomitant medications include: Losartan and Atenolol. Vaccine was administered at approximately 5:00 pm at a drive through location. The vaccination was administered by the County Health Department. Shortly after receiving the vaccine (but while still at the facility), patient started experiencing a bulging of the right eyelid. Patient did not immediately recognize that this may have been related to the vaccination. Over the next several days, patient started experiencing additional symptoms including drooping of right side of face, drooping of right eyelid, difficulty closing right eyelid and weakness on the right side of the face. This was unusual and on 02/10/2021, patient contacted her primary care physician who referred her immediately to Emergency Department for evaluation. The following tests and procedures were performed by the ER: Basic Metabolic Panel, CBC Hemogram, Troponin, eGFR and CT Head w/o Contrast (reason facial drooping). Diagnosis: Bell's Palsy, Adult. On 2/11/21, patient had a follow-up with primary care physician. On 02/11/2021, the patient received prednisone (10 mg once daily for 5 days) as treatment for the Bell's Palsy. The reported events required visit to Emergency Room on 02/10/2021 with follow-up at Physician's office on 02/11/2021. Reporting is delayed because patient understood that the adverse event had already been reported. At a later date, patient requested a copy of the adverse event report for her records but learned that the adverse event actually had not been reported. Report is being filed by a contactable family member.
81 2021-05-09 pain in extremity You got your vaccine, she had a sore arm, but otherwise nothing. She then developed blisters on he... Read more
You got your vaccine, she had a sore arm, but otherwise nothing. She then developed blisters on her feet that started out small, and progressed to be huge blisters. She now has very blotchy skin on both arms. The left foot blister were worse than the right foot that eventually burst, and 3" long and 2" wide. Mainly on the big toes and third toe of both feet. They were itchy and came very red and blotchy. Now is very dry skin and very scaly. She has not worn shoes for a couple of weeks due to the blisters, and is still not able to wear them still. She saw her doctor on the 30th and he did not give her anything to take as he said that he didn't know what it was in order to treat her. She made a FU appointment and told her if they burst and it doesn't look any worse than when he saw her then to keep on doing what she was doing. She has been putting on triple antibiotic ointment, and keep her feet elevated.
81 2021-05-10 pain in extremity feeling a bit achy; her arms hurting; having a little cough; earache; she is stressed out; This is a... Read more
feeling a bit achy; her arms hurting; having a little cough; earache; she is stressed out; This is a spontaneous report received from a contactable nurse and a consumer (patient). An 81-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date at 81 years old (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included tofacitinib citrate (XELJANZ) from Feb2021 and ongoing. Patient reported feeling a bit achy and her arms hurting after taking her first dose of the covid-19 vaccine. Patient also reported having a little cough and ear ache. Patient stated this happened when she was stressed out. The adverse events were non-serious. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
81 2021-05-12 weakness, mild one side paralysis, slurring ears went dead with no sound to be heard, went to walk felt like could not control body, was swayin... Read more
ears went dead with no sound to be heard, went to walk felt like could not control body, was swaying all over the place, and really sick. sick to stomach when stroke started happening, weaknesses everywhere could not stand up or get up in bed. Started throwing bike up really bad , dizziness happening, spilled out both ends of body, speech little slurred, stroke was happening. Got to hospital still felt dizzy for at least 3 days, throwing up lasted several hours. Zoned out in hospital for awhile but not while stroke was happening, in intensive care for 2 full days, in hospital for 3 days then transferred to rehab in hospital. Left side was affected both arm and leg and slurry speech. Little weakness in right arm. Home from rehab 2 weeks later. Still having issues with leg.
81 2021-05-12 weakness ED to Hosp-Admission Discharged 4/6/2021 - 4/9/2021 (3 days) Last attending ? Treatment team Acu... Read more
ED to Hosp-Admission Discharged 4/6/2021 - 4/9/2021 (3 days) Last attending ? Treatment team Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) Principal problem Discharge Summary Internal Medicine Discharge Summary Hospitalist Medicine Admission Date: 4/6/2021 Length of Stay: 3 Days Discharge Date: 4/9/2021 Admission Diagnosis Hospital Problems POA * (Principal) Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) Yes Type 2 diabetes mellitus (CMS/HCC) Yes Obesity Yes Hypothyroidism Yes Chronic combined systolic and diastolic heart failure (CMS/HCC) Yes Benign essential hypertension Yes 81-year-old female presented to the hospital with a complaint of fever and cough COVID-19 - now saturating well on room air and Afebrile Complaining of sore throat and difficulty in swallowing- now resolving Back pain improving Episode of diaphoresis and blurry vision -now resolved Home Or Self Care CODE STATUS: DNR (Do Not Resuscitate) Active Issues Requiring Follow-up Follow-up with PCP for further care as outpatient. Test Results Pending at Discharge Pending Labs Order Current Status Blood culture- 2 SETS Preliminary result Blood culture- 2 SETS Preliminary result Hospital Course HPI: See H&P Hospital Course: Patient presented to the hospital with a complaint of fever and cough. She was admitted for COVID-19 with respiratory failure. Since she was saturating below 94%, she was started on remdesivir on admission. Oxygen was given for supportive care. She received albuterol inhaler, Mucinex, Tessalon Perles and Decadron. In addition she complained of some sore throat and received Chloraseptic spray along with lozenges. She had an episode of diaphoresis and change in vision during the hospitalization. There were no events on the monitor and the CT of the head was negative. The symptoms resolved. She also complained of insomnia back pain for which he received melatonin and Lidoderm patch respectively. She is feeling much better and has been saturating well on room air above 95% for the past 2 days. I will continue with the albuterol inhaler, Decadron and Mucinex as outpatient for few more days. She is asked to follow-up with her PCP for further care as outpatient. ED to Hosp-Admission Discharged 4/13/2021 - 4/16/2021 (3 days) Last attending ? Treatment team Weakness Principal problem Discharge Summary (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Admission Date: 4/13/2021 Length of Stay: 1 Days Discharge Date: 4/16/2021 Admission Diagnosis Hospital Problems POA Type 2 diabetes mellitus (CMS/HCC) Yes Hypothyroidism Yes Hyperlipidemia due to type 2 diabetes mellitus (CMS/HCC) Yes Gastroesophageal reflux disease Yes Problem List Resolved POA Resolved Problems Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) 4/17/2021 Yes * (Principal) Weakness 4/17/2021 Yes Generalized weakness 4/17/2021 Yes Home Under Care Of Organized Home Health Service CODE STATUS: Prior Active Issues Requiring Follow-up Test Results Pending at Discharge Hospital Course HPI: See H&P admit report. Hospital Course: Patient was admitted secondary to weakness and hypoxia she recently did have a bout of COVID-19 and had been discharged home and has been set up for remote outpatient monitoring as per protocol. She returns for ongoing weakness. Patient was continued on Decadron and was seen by physical therapy and Occupational Therapy. The patient slowly continued to improve and was now back to baseline functioning. She may be discharged home and follow-up with PCP as advised as she is no longer on oxygen. She is to complete the dexamethasone dose as she had previously been taking to complete a course. Home health had been previously set up at her previous admission.
81 2021-05-12 speech disorder Patient's daughter reported that about 2 weeks after second vaccine her mother became very ill. She ... Read more
Patient's daughter reported that about 2 weeks after second vaccine her mother became very ill. She was having trouble talking, walking, and moving. She stated that she had been taken to the hospital and it was possibly a stroke. We have since spoken with the patient on multiple occasions on the phone and she has not mentioned problems concerning her vaccine.
81 2021-05-13 pain in extremity rash on her arm./2 spots/it went down to her arm and elbow; Experiencing pain down her shoulder to h... Read more
rash on her arm./2 spots/it went down to her arm and elbow; Experiencing pain down her shoulder to her hand/excruciating pain/pain in her arm; shingles on her arm; hardly sleep at night; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 29Mar2021 (at the age of 81 years old) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first vaccination of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on Mar2021 for COVID-19 immunization and had no reaction. It was reported that on 29Mar2021, she received the second dose and 10 days later (08Apr2021), she started experiencing pain down her shoulder to her hand. She described it as "excruciating pain". It lasted for almost 7 days and is still ongoing. She could hardly sleep at night due to the pain in her arm. It looks like she may have shingles on her arm, as per her doctor. She added that she now has a rash on her arm. Yesterday, she had 2 spots and today it went down to her arm and elbow. Her doctor prescribed her antivirals. The outcome of the events shingles on her arm, hardly sleep at night and rash on her arm./2 spots/it went down to her arm and elbow was unknown; outcome of Experiencing pain down her shoulder to her hand/excruciating pain/pain in her arm was not recovered. She also added that her daughter received the vaccine and also has pain in her arm now. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
81 2021-05-17 pain in extremity Fever, chills-several hours. Headache-1 day. Sore arm-3 days. Swelling and redness around injectio... Read more
Fever, chills-several hours. Headache-1 day. Sore arm-3 days. Swelling and redness around injection site-4 days ,
81 2021-05-18 pain in extremity I received the vaccine at 3:15, due to my allergies I stayed for 45 minutes. I walked to car and fel... Read more
I received the vaccine at 3:15, due to my allergies I stayed for 45 minutes. I walked to car and felt dizzy driving home. I was seeing lighting bolts in visual field. I felt fatigued and foggy. I had chills, fever, a pain from the top of my legs to my feet . I had no reaction on the arm that I received the vaccine, I had pain in the opposite arm. I had pain from my neck to my waist in the back of me, no pain in chest area. Each day following I had headaches that went into optic migraines. Continues from the shot up to present. I have been taking Tylenol each and every day. I don't normally take over the counter medication. I have had less stamina since the injection. I am doing 50% of my daily routine due to fatigue
81 2021-05-25 weakness Patient brought to the ED with generalized weakness worsening over prior 2-3 days, states she starte... Read more
Patient brought to the ED with generalized weakness worsening over prior 2-3 days, states she started experiencing after receiving 2nd dose of Covid vaccine. Found to have a positive troponin, hyponatremia. Stress test revealed reversible myocardial ischemia of the inferior and lateral walls of left ventricle with a large defect size but mild defect severity. Patient underwent PCI with DES placement and was placed on triple therapy with aspirin, clopidogrel and eliquis. Patient presented to ED again on 5/23/21 outcome: patient is brought to ED after a fall and loss of unconsciousness, hit her head with large laceration at back of head, 2 episodes of vomiting, leading to terminal events: brainstem compression and rapid deterioration and CS of 2T preclude meaningful survival
81 2021-05-31 mild one side paralysis, tingling Heavy right foot 4/13 in afternoon. Then Thursday at 2:30am got up to go to the bathroom and had a ... Read more
Heavy right foot 4/13 in afternoon. Then Thursday at 2:30am got up to go to the bathroom and had a difficult time walking and returned to bed afterward and had tingling sensation in right arm. Next morning still felt odd and at 8:00am went to primary and he sent her to the ER room. They ran many test and then discovered she had a stroke. There was damage also to the heart. She had lost all mobility in her right side but has since regained it. Transferred to hopital for 3 days. Many test ran. Never previous heart damage or issue with Blood pressure. Supplement list cont. - Immune Defense, B, Apha GPC, Theanine
81 2021-06-01 weakness feeling weak/had no energy all day; nervous; a lot of pain in the injection site (left arm); chills;... Read more
feeling weak/had no energy all day; nervous; a lot of pain in the injection site (left arm); chills; a mild fever/Fever chills; one swollen lymph node on the right side; muscles aching; tiredness; This is a spontaneous report from a contactable consumer (patient). A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9261; Expiration Date: 31May2021), via an unspecified route of administration, in left arm on 01Feb2021 11:30, as 1st dose, single for covid-19 immunisation. Medical history included sinusitis from an unknown date and unknown if ongoing, neuropathy peripheral from an unknown date and unknown if ongoing and anxiety. Patient explained that she had trouble with the flu shot prior, having weakness and low blood pressure and that's why she got so nervous to get it, she was exhausted from that. There were no concomitant medications. After the onset of events, her husband suggested to take benadryl, and so she took 1 yesterday. Patient received the first dose of the Pfizer COVID vaccine 01Feb2021. Medical Conditions was she actually had a physical a week ago, her heart is fine, the doctor said her blood work was normal. Patient was calling about the Covid Vaccine, she got it the day before yesterday. She experienced "a lot of pain in the injection site (left arm) the first night after the injection. She also experienced tiredness on 01Feb2021, chills, a mild fever on 02Feb2021, one swollen lymph node on the right side on 02Feb2021 and has been feeling weak. She reported that she spoke with someone else prior to speaking with medical information and stated she gave them "her information" about the side effects. Her muscles aching, the chills, the swollen lymph node on the right side started on 02FEB2021. She was also mostly tired with no energy she had a little bit fever since she had the chills. She was just feeling unwell like she got the flu. Caller stated that it was just the normal flu shot, she hasn't had it for 5-6 years now. She has no lot number to provide. Her doctor said if it causes trouble then don't get it, a couple times she was in urgent care because of the low blood pressure, like she was going to pass out. The chills she just had once or twice yesterday. She didn't take a temperature. She clarifies that it was just 1 lymph node that was sore and raised, she can barely feel it today, it went down. Today she still felt the weakness and tiredness. Caller would like to know if it was ok for her to take Tylenol for her post vaccination symptoms. The patient underwent lab tests and procedures which included blood pressure abnormal was low and blood test was normal. Investigation assessment included All tests were normal. Patient does have anxiety; however, caller thinks that it was this covid situation and the depressing news every day. Outcome of the events tiredness was not recovered, event one swollen lymph node on the right side was recovering and unknown for all other events. Follow up (03Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported, new information included: Description of the reporter patient characteristics (age weight, height), relevant medical history and concurrent condition, reaction/events (onset date outcome), suspect Information, lab test were updated. Follow-up attempts are completed. No further information is expected.
81 2021-06-01 pain in extremity Fever; Chills; Her legs got extremely sore/Legs got so sore; both legs; This is a spontaneous report... Read more
Fever; Chills; Her legs got extremely sore/Legs got so sore; both legs; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 82-year-old female patient received bnt162b2 first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in right arm on 21Mar2021 at 12:00 (at the age of 81-year-old) as 1st dose, single dose for covid-19 immunisation. Medical history included ongoing high blood pressure (Diagnosed a long time ago), Crippled leg from an unknown date and unknown if ongoing (she is dragging one and trying to walk on the other one and she can't hardly get around on it), eyesight is not that good from an unknown date and unknown if ongoing (she can't see that well), ongoing pain in a disc in her back from an unknown date and unknown if ongoing. Concomitant medication(s) included tramadol (MANUFACTURER UNKNOWN) taken for pain in a disc in her back from an unspecified start date and ongoing at a dose of 50mg twice a day; gabapentin (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified start date and ongoing at a dose of 300mg twice a day; lorazepam (MANUFACTURER UNKNOWN) taken for an unspecified indication from an unspecified start date and ongoing at a dose of 2mg once a day at night; nifedipine (MANUFACTURER UNKNOWN) taken for blood pressure increased from an unspecified start date and ongoing at a dose of 60mg once a day. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient previously took IV iron for the indication of iron falls low; Furosemide and experienced cramp (Dose: 20mg, she is also on a water pill, Furosemide but it was not taken in the two weeks). The patient experienced Her legs got extremely sore/Legs got so sore; both legs, fever and chills. Fever and chills lasted only one day but is still experiencing sore legs but it has it improved slightly. It was reported that it hurts to get up, she already has a crippled leg, she is dragging one and trying to walk on the other one and she can't hardly get around on it. Caller clarifies it hurts from her butt down on her legs. The reporter states she can't take aspirin, codeine, penicillin or could not have strawberries. The patient did not visit emergency room or physician office. The outcome of the events Her legs got extremely sore/Legs got so sore; both legs was recovering while for fever and chills was recovered on 21Mar2021. No follow-up attempts are needed. No further information is expected.
81 2021-06-03 pain in extremity Equilibrium affected; I could not hear; I woke up with pressure in both of my ears; Deaf in my right... Read more
Equilibrium affected; I could not hear; I woke up with pressure in both of my ears; Deaf in my right ear; arm soreness; This is a spontaneous report received from a contactable Nurse (patient). An 81-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: TR2613; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in left arm on 21Apr2021 at 09:00 as 1st DOSE, SINGLE for covid-19 immunization. Medical history included atrial tachycardia (From: 2015 To: Unspecified), macular degeneration diagnosed about 3-5 years ago, low thyroid hormone seems like she's had forever, high cholesterol just beyond normal has had for years, latex allergy since the 1980's, banana, avocado, and kiwi allergy (states all are interrelated because they are cousins to the rubber tree plant and also healthcare personnel allergic to latex can and may develop a cross allergy to psyllium which is Metamucil), Psyllium allergy (states she had an anaphylactic reaction to a metapower bar in 2015. About 7 minutes after eating the bar, she went into a severe reaction and ended up in the emergency room and stayed overnight. thankfully was at work). Reported having shingles vaccination in 2014 and had shingles 2-3 weeks later, can't remember details. States it was a mild case. NDC, lot, expiry unknown. She stated every flu shot she received, she has gotten the flu and only takes periodically. States she retired in 2017 and had to take in 2016 and 2015, she would have lost her job if she didn't take. It had been 5-10 years before that, and another 5-10 years before that. States she stays away from the flu shot. Concomitant medications included metoprolol ER from Jan 2016 for atrial tachycardia, SYNTHROID started about 15 years ago for low thyroid hormone, Simvastatin ongoing, started about a year ago for cholesterol slightly elevated, OCUVITE PreserVision(Ongoing) taking about 3 years for macular degeneration age related has not changed or gotten worse in 3 years, baby aspirin started Jan 2016 (Ongoing) as cardiologist thought it would be a good idea, Vitamin D3: taking for 3 years (ongoing) for bone health, calcium with magnesium been taking a long time. 5-10 years to prevent osteoporosis (ongoing), glucosamine chondroitin taking since late 1990s. about 20 years for joint health (ongoing), multivitamin taking since 1995 or 1996. about 25 years for general health, vitamin C about 3 years ago started with the Ocuvite (eye doctor though it was a good idea to take together. On April 28th2021 patient could not hear. She was deaf in right ear and the day before on April 27 it was like she woke up with pressure in both ears. It sounded like hell like she was in the airplane and by yawning she could not relieve the pressure and went to the doctor and was under treatment with steroids and antivirals and still deaf in right ear." She confirmed pressure is gone, but still deaf and under medical treatment with otolaryngology. She was kind of tossing whether to get the vaccine or not. First went to family doctor to see, didn't think she had an ear infection because no pain and was hoping maybe she would have wax in her ear, but ears were clean and no wax. So they sent her to an ear specialist and they did hearing test and she has pretty severe hearing loss in that ear. So she was still being treated. First the doctor put her on valacyclovir and methylprednisone for about 7 days and then that didn't seem to do anything and now she's getting dexamethasone injections into her middle ear. States she is due for one about lunch time. Pressure in both ears: patient reported has subsided, but then confirms it is a lasting effect comes and goes a little bit. Left ear is pretty much clear but right ear still has pressure and cannot hear and has not subsided. On an unknown date her equilibrium affected and stated has gotten slightly better, minuscule. Patient added she's pretty healthy and moves about, gardens takes care of business, goes to exercise class twice a week now partially participates because she gets dizzy from moving her head. Patient was treated with Valacyclovir: 1 gram tablet every 6 or 8 hours, states can't remember. Started 05MAY2021 for 7 days. Caller confirmed it did not help and she threw bottle away. Methylprednisone: 4 mg tablet by mouth started dose at every 4 or 5 hours, dose was a decreasing frequency of dose over 7 days. Confirmed she threw package away. Stated cortisone decreases irritation and inflammation. And Valacyclovir is an antiviral. Started dexamethasone injections last Thursday, 20 May 2021. Is scheduled to receive a dose today, will skip next week, and then one the following week, and then one the following week after that, states it is a series of four doses and then if that doesn't help she will have an MRI. Airborne: started taking about one week ago after first dexamethasone injection through tympanic membrane into middle ear. Relevant Tests: Hearing Test (Date: 05MAY2021)Result: pretty severe hearing loss in right ear, Test: Ear exam (Date: 03MAY2021; 05MAY2021) Result: Normal. Outcome for pain in extremity was recovered, for ear discomfort and deafness it was resolving, for hypoacusis and. equilibrium affected it was unknown. Reporter seriousness for pressure in both ears and equilibrium affected: Medically significant, Deafness right ear: Disabling, Arm soreness: non-serious Reporter causality: deafness in right ear: Causality: strong suspicion it's related to the vaccine, maybe not necessarily the vaccine itself, but her immune system reaction to the vaccine. Causality for pressure in both ear, arm soreness and equilibrium: related; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events such as deafness,balance disorder and ear discomfort cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
81 2021-06-07 weakness, inability to speak, slurring Two days after patient's first vaccine@ about 4 pm, I could tell that something was wrong with her. ... Read more
Two days after patient's first vaccine@ about 4 pm, I could tell that something was wrong with her. Every day she and I play cards, but this day she was really struggling. She couldn't figure out where any of the cards went, and was missing every play. I tool her up to lay down. At about 6pm, her eyes looked really glassy and she was unable to speak clearly. Her words were very slurred, and her sentences did not make any sense. I called 911, and they came and took her to the ER. The doctors said that she had a small stroke. She was put on a low dosage of blood pressure medicine, and was hospitalized for 6 days to monitor her. During that time many tests were run on her. 2nd Vaccine- 2-24-21 Two hours after returning from getting the second vaccine, the patient went upstairs to go to the bathroom and she passed out onto the bathroom floor. Again, when talking to her, her words were slurred. She was very weak. I called 911 again. Initially they were not going to take her, but when she went to get up she fell back down. She was too weak to walk, so they took her to the ER again. She was released to go home that evening. Sher saw her primary doctor and was referred by her oncologist to see a hematologist. She endured a three month waiting period until she could be tested for APLS. She will go this Friday to find out the reslts of that test. Additionally, she saw her vascular neurologist, Dr. He looked at her scans and said it was NOT a stroke. He said that her body basically had a surge as a result of trying to fight off the vaccine. He said that the CAT scan that was done at the time she went to the ER the first time did NOT indicate signs of a new stroke, but that what they were seeing on the scans was from her past stroke. Dr. said that he saw no indication that she had another stroke and that her body was just reacting to the vaccine. He said that all of the symptoms that she had were all things that could happen because of the surge.
81 2021-06-07 burning sensation Tongue, cheek, lips, roof of mouth, also mucous membrane inside of back nostrils were burning, swell... Read more
Tongue, cheek, lips, roof of mouth, also mucous membrane inside of back nostrils were burning, swelling; Tongue, cheek, lips, roof of mouth, also mucous membrane inside of back nostrils were burning, swelling; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 29Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer or other non hcp (patient). An 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular, administered in Deltoid Right on 25Feb2021 13:00 (Batch/Lot Number: EN6198) (at the age of 81-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included restless legs syndrome from an unknown date and unknown if ongoing, multiple allergies from an unknown date and unknown if ongoing, Handicap from an unknown date and unknown if ongoing (7 years), ongoing end stage osteoarthritis (No surgical procedure), allergic to Ampicillin and Penicillin from an unknown date and unknown if ongoing (Patient has had previous allergic reactions 7 years ago and allergic to all other major antibiotics), ongoing chronic pain (No surgical procedure), ongoing fibromyalgia (no surgical procedures), ongoing high blood pressure (no surgical procedures), Lung cancer from Mar2019 and ongoing (MRI's show tumour diminishing. Had radiation in 2019- Stereotactic body radio surgery), allergic to major antibiotics from an unknown date and unknown if ongoing (she had a thick tongue and a puffy roof of her mouth and irritated tongue) and Stereotactic body radio surgery on 2019, chemical sensitivities from an unknown date and unknown if ongoing and PEG reaction to Nutelee from an unknown date and unknown if ongoing. Concomitant medication(s) included oxycodone (MANUFACTURER UNKNOWN, Strength: 10mg) taken for pain from an unspecified start date and ongoing; paracetamol (TYLENOL, Strength: 500mg) taken for pain from an unspecified start date and ongoing; losartan potassium (COZAAR, Strength: 100mg) taken for hypertension from an unspecified start date and ongoing. The patient did not receive any other vaccine prior to bnt162b2. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL8982) via intramuscular administered Left Arm deltoid at 13:00 (at the age of 81-years-old) on 04Feb2021 and experienced Headache, soreness in the arm, random itchiness, increased fatigue, inside of cheeks were puffy, Irritation roof of mouth, tongue was raw, red, and puffy on 04Feb2021 and mucous membranes inside her nose were burning on 05Feb2021, her restless leg was increased, joint and muscle pain. The patient previously took Ampicillin and experienced allergic to Ampicillin and rash (30years ago). The patient experienced Tongue, cheek, lips, roof of mouth, also mucous membrane inside of back nostrils were burning, swelling on 25Feb2021 at 17:00. The patient was advised by physician in phone to take 10mg of Claritin the day before, day of a several days after 2nd dose. It was reported that patient was supposed to have elective surgery, so her doctor wanted to make sure she would be able to take an antibiotic, so her allergist chose Ampicillin. Penicillin NDC/LOT/EXP: Unknown. The patient heard that whatever side effects experienced during first dose they will be more intense after the second dose. Caller says she has not had any other recent vaccinations or started any new medications. She says she has eaten or drank nothing different recently. The patient Claritin 10mg for allergic reaction from 24feb2021 to 28Feb2021 as suggested by the physician. The patient had undergone covid test on 27Oct2020 resulted negative and on 25Jan2021 resulted in negative, and MRI on an unknown date was resulted in tumour diminishing. The patient kept in contact with the allergist through phone. The outcome of the events Tongue, cheek, lips, roof of mouth, also mucous membrane inside of back nostrils were burning, swelling was resolved on 02Mar2021.
81 2021-06-07 feeling hot slept all day, very tired; mouth and throat was dry; mouth and throat was dry; problems with stomach... Read more
slept all day, very tired; mouth and throat was dry; mouth and throat was dry; problems with stomach, like hurting; stomach felt warm; could taste shot; Felt terrible; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in right arm on 06Mar2021 at 09:15 (Batch/Lot Number: EN6200) at the age of 81-year-old as second dose single for COVID-19 immunisation. Medical history included ongoing restless legs syndrome, sinus and nose run. She takes a blood pressure medicine and she has restless leg syndrome that she takes a medicine for. She had a regular check up in Dec2020. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EL9269), via an unspecified route of administration, on 13Feb2021 at the age of 81-year-old, as first dose single, for COVID-19 immunization and the patient experienced no adverse events. On 06Mar2021 at 17:30 the patient experienced problems with stomach, like hurting, stomach felt warm, could taste shot and on 07Mar2021 experienced slept all day, very tired, mouth and throat was dry. The patient reported when they gave her the shot she tasted it and then about 17:30 on 06Mar2021 she started having problems with her stomach. Her stomach started hurting. Then it felt like when you put your hand on your stomach like putting your hand on your head for a fever that it felt warm. She felt terrible. On 07Mar2021 she slept all day and she didn't feel like going to work on 08Mar2021 and she's not one that misses work. She only weighs less than 85 pounds, she did not know if her weight had something to do with that. Her husband took the COVID-19 vaccine and he didn't have any side effects. She told her doctor that she wasn't going to get the COVID-19 vaccine until he did. And he got it. It's not like her to sleep all day. She reported her mouth was dry as it could be, like she had cotton in her mouth. She's never sick, she doesn't miss days at work. Is there anything she can take? Her daughter had said people do get sick and it lasts about 24 hours and then they feel better. She took aspirin clarified as Dollar General Pain Relief 500mg, she took 3 at one time. She takes Dollar General Pain Relief when she has a bad headache. She doesn't usually have headaches. She reports the Dollar General Pain Relief did help. Expired 2019 she didn't even see that, that's how much she doesn't use them. She sees AO561 on bottle. She usually does and goes and goes, she's usually doing something. She woke up on 07Mar2021 and her mouth was dry, she has sinus, but her nose usually runs. Clarified nose did has not run since getting the COVID-19 vaccine. Her stomach was better on 08Mar2021 but her throat was still dry. At least her stomach was not hurting. She felt better last night (07Mar2021). She's feeling better and decided take one more day off to not overdo it. She reported that her stomach felt real warm like her stomach had a fever but she did not have a fever and her stomach is fine now. The events did not require emergency room visit or physician office visit. Outcome of mouth and throat was dry was not recovered, outcome of problems with stomach, like hurting and stomach felt warm was recovered in Mar2021, felt terrible was recovering, while outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.
81 2021-06-09 facial paralysis, bell's palsy Twelve days (03/31/2021) after receiving the 2nd dose of the vaccine, my face was starting to droop ... Read more
Twelve days (03/31/2021) after receiving the 2nd dose of the vaccine, my face was starting to droop a lot. It was totally distorted. My eyebrows were down and my mouth my going to the left. I called my doctor and she suggested that we go to the ER. My son drove me there and I was diagnosed with Bell's-Palsy. I had an MRI, with dye, to eliminate the thoughts of a stroke. I also had blood drawn for testing. I was given Prednisone and the generic of Valtrex. As of today, it is a little bit better, but it's still here. One of my eyebrows is still drooping, my lip is half swollen, my eye is starting to close a little on it's own. For two months after receiving the vaccine, I had to pull my eyelid down and cover it with gauze and tape it at night so it wouldn't dry out and get infected.
81 2021-06-10 weakness SOB, weakness, fatigue for 3wks
81 2021-06-15 pain in extremity Intense pain in upper thigh, both legs; sometimes unable to walk/ could barely walk/ could hardly wa... Read more
Intense pain in upper thigh, both legs; sometimes unable to walk/ could barely walk/ could hardly walk; muscle weakness; Cannot sleep at night; Had pain pretty much all day, This was intense pain and it kind of changed a little bit during the day; muscle pain in arms; 'BUN' test was outside of the parameters; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 (Batch/Lot Number: EN6205) (at the age of 81 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included low back pain, overactive bladder urgency, allergies: dye in CT scan, type 2 diabetes mellitus, flu, been achy, hip replaced about 2 years ago in 2019. Concomitant medications included metformin taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; glimepiride (GLIMIPRIME) taken for an unspecified indication, start and stop date were not reported; omeprazole taken for an unspecified indication, start and stop date were not reported. Patient previously took modafinil (PROVIGIL). Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 14:30 (Batch/Lot Number: EL9264) (at the age of 81 years) as single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. It was reported that patient experienced intense pain in upper thigh, both legs, sometimes unable to walk, general muscle weakness, began 48 hrs post-2nd vaccine (also reported as occurring on 10Mar2021 22:00). Became less in 24 hrs, became intense again in another 24 hrs, and has continued ever since. Patient cannot sleep at night. Patient clarified she had it ever since 48 hours after second dose on 01Mar2021 and it's very unpleasant and does not know what to do about it and wanted to report it. These did not happen immediately and after second vaccine, patient did not have any problem till 48 hours, 10 o'clock, she had it on Monday at 12:00 and at 10 o'clock in the evening on Wednesday, she started to get intense pain on right side, she could barely walk and she have never had pain there before and she tried to walk and she was 81, she goes to the bathroom frequently with bladder issues and that was hard and it went on all night. In the morning, she had it not only in right leg but upper side like above the knees but in the front not in the back of the leg and then the next day, when she woke up and then, she had it in the upper side in left leg and closer to the groin and more like around and didn't know what to do and she wasn't going to go to an emergency ward as she was 81 and she doesn't go around that easily. Patient called her doctor, and patient had pain pretty much all day and he said how was it now and told him that it was slightly better. He said more than likely it will go away but he kept saying these are the kind of side effects that they were reporting though flu like achiness was nothing like what she had, she have had the flu (history) and been achy (history) but this wasn't like that. This was intense pain and it kind of changed a little bit during the day but it was still there. Her doctor said, if it doesn't go away by tomorrow morning which was Friday, then make an appointment and come in to see her, she will do blood work or whatever. So, she got an appointment for 2:30, by noon, it was just gone totally gone like if it never had been there. She cancelled the appointment then yesterday she got it back again and she could hardly walk but it wasn't as intense, it was really painful and hard for her to walk and it was around both legs and she doesn't know what to make of that, she went to rheumatologist because she thought she might be having muscle pain in arms from something else, he did some blood work (unknown results), he couldn't make anything out of it and he said he will look at the blood work and he gave her kind of a steroid cream to rub on arm (treatment) which she thought she had a problem but months ago (consumer was not sure). Now she couldn't sleep last night, it was so uncomfortable, and she had to go to the bathroom several times and again it really hurts to walk. So, that was what happened to her and she would not call that achiness of the flu at all. Regarding treatment, patient took Tylenol, do take other medications but nothing unusual and take the same that she always have and by the way the intense pain was only in one leg for twelve to twenty hours and then all of a sudden it began in the left leg as well and slightly with different pace but still on. The one in the right leg was most intense, she could barely stand. For laboratory test, the 'BUN' test was outside of the parameters and after getting several tests he did, she wanted to see if she had some sort of rheumatoid thing and they are all in her record. This was not one of the typically adverse reactions that people reported at least according to what she read and according to aspects of it. The outcome of events pain, muscle pain in arms, and BUN abnormal was unknown while for other events was not recovered. No follow-up attempts are needed. No further information is expected.
81 2021-06-16 sensory loss, electric shock sensation This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EP7534, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 18 Mar 2021 (at the age of 81-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history included chest pain, high cholesterol, congestion in her throat and lungs. It occurred prior to Christmas 2020. She had issues from COVID-19 and stated that she feels weaker because she used to walk like 4 miles a day and now, she was not walking due to the pandemic. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN], taken for high cholesterol; acetylsalicylic acid (ASPIRIN 81). Patient did a cardiac test, and they came back negative. Heart was fine. It still has not resolved though. Patient reported that she had the first dose last week and had a couple of things that she needed to report. She usually has a rapid heartbeat and has always been able to feel her heart beating and been able to hear heart beating. Caller said that she had her heart tested because of her having a rapid heart rate previously. Caller said that since the dose, she could not feel any sensations around her heart and even if she turns over to push up on her arm, she could usually feel her heartbeat and now she could not. She also could not hear it anymore. She said that it is kind of strange, unusual for her. Caller said that she could feel her heartbeat when she was watching TV. Caller said that she could not feel any sensations around her heart now on 18Mar2021. She said that the next night, 19Mar2021, she felt a buzz from her feet up her left size up to her neck. It was like a shock buzz, but it did not last. Last night, 21Mar2021, she had from her waist to her chest a big jolt to her system. It was just the one jolt. She tried to call her doctor to report this, and they directed her to call Pfizer. She said that she feels fine otherwise. She said that she has gained weight during the pandemic. Caller said that her not being able to feel the sensation in her heart started the evening of her receiving the vaccine 18Mar2021. Her toes do feel like there is a different sensation in them, but they are not really numb, but feel different. That started on the second night 19Mar2021 and this ongoing. It does not feel bad, just different. Second dose was scheduled for 08Apr2021. She may not get it if her symptoms are not resolved. The outcome of the event cannot feel any sensations around her heart and toes do feel like there was a different sensation in them was not resolved, outcome was resolved for events felt a buzz on 19Mar2021, outcome was resolved for event had from her waist to her chest, a big jolt to her system on 21Mar2021.
81 2021-06-18 pain in extremity Itchy; large rash; hot at the upper arm; upper arm sore; This is a spontaneous report from a contact... Read more
Itchy; large rash; hot at the upper arm; upper arm sore; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EL9261), dose 1 via an unspecified route of administration, administered in Arm Left on 23Jan2021 07:59 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure, Cardiac, Cholesterol from an unknown date and unknown if ongoing. Concomitant medication included lisinopril (LISINOPRIL) taken for hypertension; rivaroxaban (XARELTO) taken for cardiac disorder; carvedilol (CARVIDOL) taken for cardiac disorder; ezetimibe (ZETIA) taken for blood cholesterol; rosuvastatin (ROSUVASTATIN) taken for blood cholesterol, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of the Pfizer COVID 19 vaccine on 23Jan2021 at 07:59AM in the left arm. States she had upper sore arm a short while later in the day. Yesterday on 02Feb2021 she first noticed her arm was itching and so she took off her clothes to look and saw she had a large rash on her upper arm, 4-5 inches long, that was hot, located at the injection site and below. Adds she thought that only happens with Moderna and not Pfizer. Mentions this occurred ten days after the vaccine. She has spoken with her HCP who did not provide any advice. Mentions all these effects cleared up by the evening of 02Feb2021 except her arm is still a little sore. She is scheduled for the second dose 13Feb2021. The outcome of the event upper arm sore was recovering and the outcome of events Itchy, large rash, hot at the upper arm was recovered on 02Feb2021. Follow-up attempts are completed. No further information is expected.
81 2021-06-20 weakness Patient presented to the ED on 5/10/2021 for weakness. Patient presented to the ED on 5/17/2021 and ... Read more
Patient presented to the ED on 5/10/2021 for weakness. Patient presented to the ED on 5/17/2021 and was subsequently hospitalized for atrial fibrillation with RVR. These visits are within weeks of receiving COVID vaccination.
81 2021-06-20 concussion I FELL TWICE AFTER 1ST VACCINE DOSE HAD HEADACHES AND I WENT TO THE DOCTOR WHO SENT ME FOR A CAT SCA... Read more
I FELL TWICE AFTER 1ST VACCINE DOSE HAD HEADACHES AND I WENT TO THE DOCTOR WHO SENT ME FOR A CAT SCAN WHICH DIAGNOSED A CONCUSSION.
81 2021-06-24 burning sensation, pain in extremity experiencing the burning sensation in "weird places" ex. hand and fingers, ankle to knee; She report... Read more
experiencing the burning sensation in "weird places" ex. hand and fingers, ankle to knee; She reported a symptom of a baseball/softball side swollen knot on her L shoulder/top of arm. The knot hurt but it was tolerable.; She reported a symptom of a baseball/softball side swollen knot on her L shoulder/top of arm. The knot hurt but it was tolerable.; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 10Mar2021 (age at the time of vaccination was 81-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) on 17Feb2021 for COVID-19 immunization. On unspecified date, she reported a symptom of a baseball/softball side swollen knot on her L shoulder/top of arm. The knot hurt but it was tolerable. She reports putting ice packs on the knot for treatment and after 3-4 weeks it gradually got smaller. The Consumer reports that she is still experiencing the burning sensation in "weird places" ex. hand and fingers, ankle to knee. She states that the feeling doesn't bother her but just wants to know if others have reported this same symptom. Treatment included ice packs for the event "she reported a symptom of a baseball/softball side swollen knot on her L shoulder/top of arm. Outcome of the events burning sensation and Peripheral swelling was unknown while pain in arm was reported as recovering. Information on the lot/batch number has been requested.
81 2021-06-30 pain in extremity, feeling cold, weakness This is a spontaneous report received from a contactable nurse (patient). A 81-year-old female patie... Read more
This is a spontaneous report received from a contactable nurse (patient). A 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6201; expiration date: 30Jun2021) via an unspecified route of administration, administered in deltoid left on 02Mar2021 11:00 as single dose for COVID-19 immunization. Medical history included Neuropathy, Diabetes, AFib, Anemia, bleeding ulcer, Rectal bleeding, Hypertension, knee bleed, osteoarthritis in hands, Bursitis, Cataracts, arthritis in knees, Stroke, hearing impairment, Diverticulitis, Internal hemorrhoids, Bunionectomy, Fall, broke her ankle, device implant, Transfusion, retinal surgery, Cataract surgery, had a positive COVID test, Cholesterol, Weak and cracked fingernails and keep blood thin, to prevent clots. Concomitant medications included Onglyza for diabetes mellitus, Pantoprazole for ulcer. Fish oil for blood cholesterol abnormal, Atorvastatin for blood cholesterol abnormal, Zocor, Colecalciferol (VITAMIN D 3), Biotin, Cyanocobalamin (Vitamin B12) for hypoaesthesia, ubidecarenone (COQ-10), macrogol 3350 (Miralax), acetylsalicylic acid (Baby Aspirin) for anticoagulant therapy, fexofenadine hydrochloride (Allegra). On an unspecified date, the patient experienced had sore arm and on 02Mar2021 had strong headache, stiffness/neck stiffness, chills, weakness, soreness all over the body, moderate soreness at the injection site after covid 19, joint pain, felt cold, tiny red spot at injection site about the size of a dime, back pain. The events were considered as non-serious by the reporter. Reporter stated that she was a Retired RN, and she had her first dose of the Pfizer Covid vaccine on 02Mar2021 at 11am, and she was scheduled for her second covid immunization on 23Mar2021. Caller has questions about side effects she experienced after the first dose and whether or not she should get the second immunization. Caller states she had a pretty strong reaction to the first injection. Caller states that she had the COVID disease in 22Oct2020, the caller went to the ER and had a positive COVID test because she had a fever, but she was sent home because her lungs were clear. She reported that both her son and her husband also got COVID around that time, but none of them had to be hospitalized. Stated that about an hour after her first injection, some soreness developed at the injection site. Later that afternoon she started to get a strong headache and her arm was getting sorer; in the evening, she started developing more joint pain in multiple joints, all over including, and especially, on her toes and feet; and her left arm was getting more sore, she got the chills, and she felt cold all the time, her temperature was 96.4; caller states that she also developed a tiny dime sized red spot at the injection site. Caller states that she also was thirsty, but she was a diabetic and that might have something to do with it. By the time it was time for her to go to sleep she was stiff and weak all over. She had neck stiffness, the feeling of being kind of stooped over. Caller was worried she would be unable to straighten up. The next morning, she still had weakness, stiffness and soreness, could hardly take a shower. She had to sit on side of tub and had to have her husband help her to get dressed. By about 10am the next day, everything started going away and by noon everything had pretty much cleared up completely and was gone. The pain in caller's feet and joints was gone by lunch and she did not have a fever. Caller states that at dinner that night, she was still weak though, and at the evening meal, she was so weak that she couldn't get up from the chair at the kitchen table alone. Once she was on her feet, she was okay, she could walk, but she uses a cane, especially when she was sick. About an hour or two later, she had a temperature of 99.4. But the next day, she didn't have a fever, and she could use that same chair without help. Caller states that she was fine by Friday and her blood sugar was 95, which was good. Caller states that she had a backache a few days following, but she has had backache before. Caller states that this was her history, she had the COVID, and she had a bleeding ulcer over a year ago now. Caller also saw a Cardiologist and had the watchman device implanted at the end of Sep2020, caller had this procedure to try and help get her off the Eliquis, which she had been on since having the stroke. Caller reports that she also had a Rectal bleed when she was put back on the Eliquis, and her doctors kept her on it because of the stroke. Caller states that she has silent A. Fib and that can throw little clots, so the doctors wanted her on a low dose of Eliquis but apparently that was too much for the caller too. Caller thinks the heart procedure is doing great and doing its job, but she was unable to go in for her follow up to the procedure, because she needed an esophageal echocardiogram to see if the device was sealed over by the heart muscle, and she couldn't have that until Jan2020, because she had to test negative for COVID twice. Caller states that her hemoglobin never really recovered more than 10 since her bleeding ulcer. But her hemoglobin went down to 7.4 and she was sent to the ER at the end of Jan2021, and she had two transfusions, and the next morning her hemoglobin went down to 7, the hospital staff thought that she must be bleeding. So the caller saw a GI doctor who said that the caller needed an endoscopy and colonoscopy to see where this was coming from, to make sure she was not bleeding from the ulcer. They saw the ulcer was healed but irritated, and the colonoscopy removed a couple polyps. The polyps were negative for cancer cells. After the caller had the COVID injection, she had blood in her stool. Caller went to the ER in the evening of 08Mar2021, and she stayed in the ER until the next morning. Caller states that the stool sample did show that there was some blood in her urine (captured as provided by the caller), and the ER did a CT of her abdomen, and they didn't see blood or diverticulitis. Caller does have a history of diverticulosis or internal hemorrhoids. Because things were going on last Fall, and things were rescheduled with the COVID disease, and things, the caller did not get her regular flu shot until 12Jan2021, because she needed two negative COVID tests prior to being able to get the Flu shot. She got two negative COVID tests on 24Dec2020 and 06Jan2021. Caller does not know if having had her flu shot in Jan2021, could have affected it. Caller was concerned and was wondering if she should take the second dose of the COVID vaccine or not. HCP Details: Caller hasn't spoken to her PCP since she was last in the hospital. She tried to call her HCP, but that office was getting a new computer system and they were having a high call volume for COVID stuff, so caller could not get through to them. Caller plans to email her doctor today. Everything has been overwhelming with all these things and people for doctors to juggle. Event Details: Caller reports that the soreness at her injection site, by the next morning, was up into her shoulder. Caller states that her niece, who was not a nurse, called the caller and told her to get the injection three fingers below the shoulder joint, because there were some instances of people getting injected into the shoulder joint. So, caller had soreness at the injection site, but within 24 hours, states that she was just sore all over, but it all went away by the afternoon the next day. Caller states that, she was told that she would have reactions more to the second injection than the first, so that was her concern, was she does not want to get the second injection and then it be worse than what she experienced. Caller had a lot of pain in her toes following the COVID injection, but she has diabetes that was well controlled, and she has neuropathy, and probably arthritis. But caller states that the pain in her toes was worse than normal, following receiving the COVID vaccine. Caller has had a bunionectomy, so she always has some numbness in the toe, and she fell and broke her ankle a few years later. But caller states that the very concerning thing was, following the COVID injection, the joint pain and soreness all over and weakness that she experienced. Caller had the stiffness together with some of the other things from her low hemoglobin anyway, as she has not fully recovered from the blood loss, but she was much better, and after the transfusions she had a hemoglobin of 10. And when caller went to the hospital lately, her hemoglobin was 9.4, and she was having it tested Tuesday morning again. Caller states that it was hard to say that everything she experienced was from the COVID vaccine, as she has a history of some of these things, including weakness. Caller finally got off the Eliquis when the hemoglobin went so low, she stopped the Eliquis maybe on 29Jan2021. Caller states that she was told by her Cardiologist that her symptoms at the time were from low Hemoglobin. Caller states that she was probably walking around with that low hemoglobin for a few days. Weakness: Caller states that at times she gets very fatigued, but she was not so weak right now. But caller states that weakness has been an up and down thing for her for the past few months, even before the COVID vaccine. Treatment: Caller took her normal Aspirin, but she did not take Tylenol even though she was told she could, and she did not take Allegra. She just took her normal medicines. History: When caller had her rectal bleed, she went into the ER on 08Mar2021, and she was sent home the next morning. Caller states that the ER was busy that evening and did not see the doctor until 10 or 11 that evening. But when the tests were finished up around 3am, the caller was told that she could go home or be admitted. Caller asked to go home but not until a little later in the morning, so she could call her family. Knee Bleed: Caller confirms it was aspirated and treated in the ER; she did not have to stay overnight. Caller saw orthopedic doctor a day or two later, and he did not order anything else. Caller walks with a cane now most the time because she is trying to avoid falling. Eliquis: Caller reports that the Eliquis was held for a few days after her GI bleed. She was taking 5mg twice a day from April or May2018. Caller had the GI bleed and the Eliquis was held for a few days and then she went back on it, then had rectal bleeding again. So, after that, caller's dose was reduced to 2.5mg twice day. The doctors did not want to take her off the Eliquis because of her prior stroke, so they just reduced her dose. The Eliquis had been preventing little TIAs and stuff in her hand and mouth and stuff. And that reduced dose was okay for a while. But caller states that she started getting those symptoms back, and several times a day she was getting the numbness, and she was scared she was going to have a stroke, so she said maybe because she was previously on mg twice a day, maybe she should up her dose to 7.5mg, and that worked well. So, caller took 5mg in the morning and 2.5mg in the evening. This was over a weekend, and on Monday the caller wrote her cardiologist, who said this dosing was not normally recommended, but if it was working for the caller, then that is okay. But then in July, the caller got the knee bleed. So, the doctors thought the caller's knee bleed was from the 2.5mg knee bleed but caller thinks she started to get that earlier because she had an episode that was similar before that, caller thought that episode in May or so was just arthritis. But, in Jul2020 her knee became swollen, very painful, and she could not get out of bed. Caller states that her son who was a weightlifter could not get her out of bed. She went to hospital via ambulance where her knee was aspirated. Caller reports that the Eliquis was not stopped due to the knee bleed, she was just told to go back to 2.5mg twice daily. Caller states that her heart doctor said that because she has had a stroke, she has to take the Eliquis to prevent stroke. Caller reports that she initially was not interested in the Watchman implant, but after all this, she decided to get that procedure so she could stop the Eliquis because she was a bleeder. The patient underwent lab tests and procedures which included colonoscopy: the ulcer was healed but irritated, endoscopy: the ulcer was healed but irritated, haemoglobin: 7.4 on Jan2021, haemoglobin: 7 on Jan2021. The outcome of sore arm and weakness was unknown, headache, stiffness/Neck stiffness, chills, soreness all over the body, moderate soreness at the injection site, Joint pain, felt cold, tiny red spot at injection site about the size of a dime were recovered on 03Mar2021 and back pain recovered on 09Mar2021.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of pain in arm,toe,headache,stiffness,chills,weakness,pain,joint pain,feeling cold,vaccination site erythema,pain and pain in toe. But also consider relevant medical history and concomittant drugs . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
81 2021-07-02 slurring 2-11-21 Blood pressure was elevated at 150/87. Appointment made at Dr. office. Seen on 2-12-21 Instr... Read more
2-11-21 Blood pressure was elevated at 150/87. Appointment made at Dr. office. Seen on 2-12-21 Instructed to monitor Blood pressure and call if remains elevated. On 2-13-21 at 7:55am I woke up with a bad headache, dizziness, and slurred speech. EMS called, Blood pressure dangerously high. I was taken to Medical Center with a Thrombolytic Stroke. I had a CT, 2 MRIs, and clot retrieval preformed. Thankfully I can still function pretty normally. The only adverse effects are slight brain damage.
81 2021-07-02 pain in extremity My arm has been sore; It has just been over my neck; my arm, shoulder was swollen; my arm, shoulder ... Read more
My arm has been sore; It has just been over my neck; my arm, shoulder was swollen; my arm, shoulder was swollen; I got up and my arm, shoulder was swollen, that hurt and then it stop hurting; This is a spontaneous report from a contactable pharmacist (patient).A 81-year-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm on 11Jun2021 (Lot Number: EW2178) at the age of 81-year-old as a single dose for covid-19 immunisation. Medical history included back injury from an unknown date and unknown if ongoing and patient on morphine for back injury. The patient's concomitant medications were not reported. The patient's arm has been sore which just been killing her and pain was also over her neck. patient was on morphine but that morphine did not even touch this and her neck is about to kill her. On 12Jun2021 patient's arm, shoulder was swollen and that hurts. The outcome of events pain in arm, shoulder pain was recovered and event pain neck, swollen arm, joint swelling was unknown. No treatment received for the events..
81 2021-07-06 difficulty speaking Started losing my voice; I can't clear my throat. It sounds scratchy. It has stayed like that. I spo... Read more
Started losing my voice; I can't clear my throat. It sounds scratchy. It has stayed like that. I spoke to my Nurse about it (in home nurse). She said it was "COVID voice." I am now trying to use some local honey (1 T in my coffee) and that doesn't help. I am going to see Ears, nose and throat doctor soon. I still work in real estate and need my voice to be clear. It's hard to push the air through.
81 2021-07-07 pain in extremity Severe muscle pains in both arms, could not lift arms to put clothes on, couldn't use arms worse at... Read more
Severe muscle pains in both arms, could not lift arms to put clothes on, couldn't use arms worse at night. felt like cutting into arms with scissors or knife did not sleep, callsed drs that week, they all said it would go away. Lasted about 8 days. Never felt pains like this. A couple of weeks later arthritis dr gave me a steriod shot which helped. but still have troubles lifting arms and moving fast up to this day
81 2021-07-09 discomfort Blood clots in Lungs discovered June 29, 2021 after being admitted to hospital June 28th. In the we... Read more
Blood clots in Lungs discovered June 29, 2021 after being admitted to hospital June 28th. In the weeks leading up to diagnoses patient was feeling extreme lethargy, nauseous, lack of appetite and general extreme discomfort.
81 2021-07-11 tremor ALTERED MENTAL STATUS, SHAKING, NAUSEA, ELEVATED BP
81 2021-07-17 slurring ALS. My mother was perfectly healthy for her age which can be attested to by her Internist noted he... Read more
ALS. My mother was perfectly healthy for her age which can be attested to by her Internist noted here in. Within 10 days of the vaccine the symptoms of Bulbar onset ALS started appearing. However, no one in the family knew what it was.
81 2021-07-17 pain in extremity ingredient in the vaccine is making her knees feel better; sore arm; This is a spontaneous report fr... Read more
ingredient in the vaccine is making her knees feel better; sore arm; This is a spontaneous report from a contactable consumer or other non hcp. An 81-year-old female patient received an unknown dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Jun2021 (at age of 81-year-old) as single dose for COVID-19 immunization. The patient medical history included "she has been having problem with her knees for quite some time". The patients concomitant medications were not reported. The patient mentioned that she has lots of medical problems and is taking lots of medication but still decided to get the vaccine yesterday. She experienced a sore arm, but so far feels okay. She has also stated that she has been having problem with her knees for quite some time. She wants to know what ingredient in the vaccine is making her knees feel better or is it just a combination of other factors. She said that "Everyone who gets the vaccine is a guinea pig. As a guinea pig, I want to know and that her physician probably did not know any of the ingredients of the vaccine". The outcome of events was unknown. Information on the lot/batch number has been requested.
81 2021-07-20 slurring Blood clots, strokes, death I believe that there were subtle unrecognized signs starting in March ... Read more
Blood clots, strokes, death I believe that there were subtle unrecognized signs starting in March - off balance, slurred speech, confusion- thought to be diabetes related. I would have her check her sugar and it would be fine, but I dismissed it as a good thing that her sugar was ok. It didn?t cross my mind until the major strokes that it could be related to the vaccine. She had major strokes in May as a result of blood clots in heart and head. I strongly believe that her death is related to the vaccine. She was well, and had her diabetes under control, and three months after getting the vaccine, she was dead.
81 2021-07-20 pain in extremity The clicking of the bone is a situation; Left brother's house about 2100, doesn't even remember driv... Read more
The clicking of the bone is a situation; Left brother's house about 2100, doesn't even remember driving away; The caller states or passed out or what the heck ever is going on with the caller's brain; The second dose Pfizer Covid 19 Vaccine was given in the right arm and had the bad side effect of excruciating pain 3.5 hours later and the pain was for some reason was in left arm.; In the evening, after done driving around doing shopping on that Saturday, 15MAY2021, did not know she fell asleep on the couch with the radio on; Had wobbly ankles, knees and hips; Had blurry eyes; Tiredness; After receiving the second dose Pfizer Covid 19 Vaccine, was what thought was a blood clot coming from the nasal area; It was extreme pain. It has not done anything but stayed in the muscle occasionally; This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported for herself. An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0176, Expiration date: 20Aug2021), via intramuscular, administered in right arm on 15May2021 (at the age of 81-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164, Expiration date: 20Aug2021), via intramuscular, administered in right arm on 24Apr2021 at 12:15 or 12:30 (at the age of 81-year-old) as DOSE 1, SINGLE. The patient medical history includes Pneumonia cryptococcal (Dormant Lung disease cryptococcus), Osteopenia, Pancreatic disorder, Crohn's disease and Colectomy (2002), Cancer, Diabetes mellitus and Polyp, aphasia and seizures (1996). Dormant Lung disease cryptcoccus, this comes from pigeons, bats and birds poo flying in the air. With allergies the caller breathed it in on some far at the time in year 2000. Checked every year since year 2000. Gastroenterologist after many undisclosed solution for drastic weight loss since year 2018, now several tests have determined the caller's pancreas and stomach are not cooperating with each other. The caller has many issues with what the Gastroenterologist are doing with the caller, she feels like a Guinea pig. Concomitant medications include PANCREATIN (CREON) for Pancreatic disorder, AMITRIPTYLINE for Cerebral disorder and CYANOCOBALAMIN (B12-VITAMIIN). The patient was taking concomitant products creon because stomach and pancreas not cooperating with each other. In relation back up to brain thing drug for that is Amitriptyline. Began taking probably 12 years ago, 10 years ago at least. B12 was taking for memory, began taking probably 4 years ago courtesy of all the testing the general physician had done. The caller states she was lacking in so much and will be on this for the rest of life. Amitriptyline was supposed to take 10mg pill twice a day but don't take twice a day. Caller is getting antsy about putting too many chemicals in the body. When the caller is crying again will take more amitriptyline. So far just upset about current Pfizer situation. Only member to have Crohn's disease and intestines removed. Gall bladder, caller has not gotten. Cancer, diabetes and polyps in family history. On 15May2021, after the vaccination, the patient experienced bad side effects of excruciating pain 3.5 hours later and the pain was for some reason was in left arm. This arm pain lasted off and on for two days. It was extreme pain. It has not done anything but stayed in the muscle occasionally, and the shoulder joint was picking occasionally, on the left and the caller still had the clicking. The pain was a normal like grade of 2 to 3 type pain at the time of this report. Whenever the caller twinges the pain happens on its own. Patient also experienced wobbly ankles, knees and hips. The caller's walking was terrible, caller states this is just persisting but at a lower level. The caller is concerned because she is a fracture risk person because of osteopenia. Patient experienced blurry eyes and tiredness. The caller usually gets blurry eyes when the caller is not hydrated enough because of loss of weight and the ileostomy bag itself is free flowing so the caller's retention is not good to begin with. The caller clarifies the infectious disease doctor when the caller was reviewed in April, prior to receiving the Pfizer Covid Vaccines, knew the caller was under weight and severely effected because the caller wears an ileostomy bag due to Chron's disease and intestines being removed twice. The caller's absorption is not normal to begin with. When the doctor's office authorized the caller to get the Pfizer Covid 19 Vaccine in the first place it was within a 20 minute response time and nobody evidently checked the caller's chart prior to approving the caller to get this serious serious of Pfizer Covid Vaccines. Which is why the caller is so annoyed. The patient fell asleep on the couch with the radio on. The caller woke up to her surprise not knowing that she had even gone to sleep for a God knows unknown period. The caller continued to listen to all her favorite shows on the Saturday night radio and it happened again, the caller doesn't know the time it was the caller fell asleep again, patient also states that she passed out or what the heck ever is going on with the caller's brain. Patient also experienced tiredness, she states she delivered the grocers and unloaded the groceries and was really wiped out. She also experienced impaired driving ability that on the way back from her brothers house she doesn't even remember driving away at about 21:00. She states God knows how many minutes later in the caller's driveway sitting at the steering wheel of the caller's car. The caller has no recollection of what transpired in the 12 miles from the brother's house to the caller's house. Patient also experienced blood clot coming from the nasal area on 15May2021. It was a tiny blood clot, not normal, red from end to end. A hair, two or three like hair from the head coming out of the left nostril when the caller blew her nose. Tiny, red tipped white, no pain, no drip, nothing except naturally what came out when the caller blew her nose, hardly. caller states this went away and didn't last at all. on 16May2021, the next day with pain in the arm was off and on. On 17May2021 patient called the doctor's office and listed all of her side effects and passed the message to whatever nurse on duty and the nurse consults the doctor. The caller had been told to do the report to Pfizer for anything wrong. Also, the caller went to the Urgent Care, they told the caller she could not get her B12 shot for memory. The caller states her memory is not too good at the present time. The event blood clot from nose assessed as serious. The patient underwent lab test includes loss of wight 97 lbs at the time of vaccine. The outcome of the event thrombosis was recovered on 15May2021. The outcome of the events loss of consciousness, Somnolence, Joint stiffness, Blurry vision, Fatigue, impaired driving ability and Bone disorder was unknown and The outcome of the event pain in arm and myalgia was recovering.
81 2021-07-22 feeling jittery Post Covid-19 vaccine (1st dose) to L Deltoid at 12:15. 12:30 Patient with c/o "dizzy, heart racing"... Read more
Post Covid-19 vaccine (1st dose) to L Deltoid at 12:15. 12:30 Patient with c/o "dizzy, heart racing" Patient transferred to wheel chair by staff, team lead and BP taken to LUA 191/78 73 and O2 sat 00% ra. Patient given sips of water and BP retaken at 12:33 154/75 62 Patient stated that she normally has high BP however, she has taken her morning metoprolol. 12:38 Patient stated she started to feel better and requested back to be raised, BP 152/85 70. At 12:40 patient informs staff that she is feeling better and wanting to stand and ready to go. Team lead notice patient unstable gait and patient verbalized being dizzy and jittery. Patient return to clinic sitting back down in wheel chair. Patient called to daughter to inform her of her condition and meet at clinic. Team lead attempted without success to encourage patient to be evaluated in ER with transport by EMS. Patient agreed to be evaluated in ED and daughter to transport. BP upon discharge from clinic was 166/89 60 with c/o head ache.
81 2021-07-22 tremor 82 y/o female, PMHx of CA, DM, HTN, hyperlipidemia, IBS, osteoporosis, RLS, seizure disorder, bladde... Read more
82 y/o female, PMHx of CA, DM, HTN, hyperlipidemia, IBS, osteoporosis, RLS, seizure disorder, bladder prolapse, and diverticulitis admitted for altered mental status, elevated blood pressure, nausea and shaking, on 6/22/21. Pt tested positive for Covid, but did not exhibit symptoms except may fever. Pt has chronic ulcers on bilateral toe with purulent drainage, undergoing wound care. Toe ulcers found to be source of infection. Was put on clindamycin, Flagyl, and vancomycin (but developed allergic reaction to vancomycin). Pt was discharged to home on 6/23/21.
82 2021-01-05 pain in extremity, pain in extremity SORE LEFT ARM
82 2021-01-11 weakness first dose on 21Dec2020/ second dose on 04Jan2021; first dose on 21Dec2020/ second dose on 04Jan2021... Read more
first dose on 21Dec2020/ second dose on 04Jan2021; first dose on 21Dec2020/ second dose on 04Jan2021; her fever went up to 101.4/ her fever is down to 99.6; still does not feel good/ felt sick/ felt terrible; wanted throw up; shaking chills; extreme weakness; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via unspecified route of administration on 21Dec2020 at single dose, and second dose (lot number: EL3246), via unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient stated that she got it in the evening and had a fever and felt sick like she wanted throw up. She stated that her fever went up to 101.4, that she felt terrible, had shaking chills and extreme weakness. She tried to drink a lot of liquids thinking that would help. Stated that it was a really bad experience. She clarified that all of these side effects were with the second dose. She had no side effects with the first dose. She reported all of this previously. She stated that she called in fever down 99.6 and did not feel good. She stated that the Tylenol brought fever down a little bit. She was still not able to go to work. The outcome of the event "her fever went up to 101.4/ her fever is down to 99.6" was recovering, the event "still does not feel good/ felt sick/ felt terrible" was not recovered, while other events were unknown.
82 2021-01-12 migraine patient experienced 3 migraines in one day
82 2021-01-13 flushing Pt started feeling short of breath about 20 minutes after vaccine was administered. Husband honked h... Read more
Pt started feeling short of breath about 20 minutes after vaccine was administered. Husband honked horn from parking lot as instructed if any adverse reactions. Initial assessment: pt SOB, flushed, able to communicate, calm. 911 called and paramedics on scence in 1 minutes (we were at Firehouse for vaccine clinic). BP 179/68, HR 88, RR 28, Ox 99%. After monitoring, paramedics cleared patient to go home. Patient started feeling better after a few minutes of paramedics arriving. Encouraged by them to take Benadryl/Tylenol for any effects and to call 911 if she started to feel SOB again or had any other concerning symptoms. Husband and pt both verbalized understanding.
82 2021-01-18 feeling hot, burning sensation, flushing her arm felt like it was on fire, body feels flushed, and felt like her throat was going to close up... Read more
her arm felt like it was on fire, body feels flushed, and felt like her throat was going to close up but it didn't; her arm felt like it was on fire, body feels flushed, and felt like her throat was going to close up but it didn't; her arm felt like it was on fire, body feels flushed, and felt like her throat was going to close up but it didn't; Injection site felt like it was on fire; Felt fine today and was fine 2-3 hours after the onset of the hot and fiery feeling; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E73246, expiry date not reported), via an unspecified route of administration on 06Jan2021 14:15 in the left arm at single dose for COVID-19 immunisation. Medical history included cardiac pacemaker insertion, high blood pressure for years. Concomitant medication included apixaban (ELIQUIS). The patient previously took flu shot (FLU VACCINE II) and never had a reaction to the flu shot, macrodantin and experienced drug hypersensitivity and hives. It was reported that about 15:15, injection site felt like it was on fire and then the whole arm felt like it was on fire. The patient got concerned. Her throat felt like it was going to close. Symptoms got less severe. She was fine yesterday and was fine that day. She called her doctor and was advised to put cold compresses on the arm and take Tylenol. She was ok. She read an article that stated if a person had a reaction to not have the second shot. She did not know if her reaction is severe. The second shot is due around 27Jan2021. She wanted to know what to do. She felt fine on the day of report and was fine 2-3 hours after the onset of the hot and fiery feeling. It was scary and she didn't know what was happening. She also added that around 15:15, the injection arm felt like it was on fire. She felt flushed. Her throat felt like it would close up but never did. Everything resolved 2-3 hours after it started. Clinical outcome of the events was recovered on 06Jan2021.
82 2021-01-19 inability to speak Stroke-like symptoms approximately 2-3 hours after receiving shot (aphasia), BP bottomed out, was tr... Read more
Stroke-like symptoms approximately 2-3 hours after receiving shot (aphasia), BP bottomed out, was transported by EMS and is currently on a ventilator in hospital. CT scan clear; MRI pending.
82 2021-01-19 weakness I have felt horrible; Every bone in my body ached except my eyebrows and eyelashes; I am so weak I h... Read more
I have felt horrible; Every bone in my body ached except my eyebrows and eyelashes; I am so weak I have no energy; I can hardly walk; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history included autoimmune disease and "bad back", both from an unknown date and ongoing. The patient's concomitant medication included prednisone for autoimmune disease and tramadol 75 mg daily for back pain. On an unspecified date, the patient reported that: "I felt horrible, every bone in my body ached except my eyebrows and eyelashes, I am just wiped out when does this go away, I am so weak I have no energy, I can hardly walk". The patient underwent lab tests and procedures which included blood test: unknown result, on an unspecified date. The patient outcome of the events was unknown. The information on the batch number has been requested.
82 2021-01-19 unresponsive to stimuli Patient unresponsive post vaccine. Taken to hospital. Please contact facility for full Report.
82 2021-01-20 tremor Patient experienced tingling lips, shaking, tremor and stomach upset and nausea
82 2021-01-21 flushing, pain in extremity after first vaccination about midnight, I rolled on to right arm and it hurt really bad, next day I ... Read more
after first vaccination about midnight, I rolled on to right arm and it hurt really bad, next day I took Acetaminophen and I noticed my lip was swollen, it went down 5 hours and yesterday 1/21/2021 flu symptoms started. Experienced fatigue, weird body ached and pains in strange locations pain in top left top of foot, left hip, back and chills and fever 101.9 and cheeks were flushed. woke up this morning and all aches and pains were gone.
82 2021-01-23 weakness C/O feeling weak and felt like her throat was closing almost immediately after receiving vaccine. P... Read more
C/O feeling weak and felt like her throat was closing almost immediately after receiving vaccine. Patient was evaluated by ED. No evidence of anaphylaxis. Treated and released without.
82 2021-01-27 weakness pt stated the night after the covid vax she had chills, headache, nausea, fever, weakness. Pt state... Read more
pt stated the night after the covid vax she had chills, headache, nausea, fever, weakness. Pt stated in bed next day since she was unsteady on her feet and had 101 fever. Pt called PCP to let them know and will FU with regular scheduled appt.
82 2021-01-27 slurring Patient observed for 15 minutes, then went to her car with her daughter, then started having slurred... Read more
Patient observed for 15 minutes, then went to her car with her daughter, then started having slurred speech, right eye twitching and right hand clenching.
82 2021-01-27 flushing, weakness DEVELOPED WEAKNESS AND FEVER OF 99.5. ALSO FLUSHING IN FACE AND LETHARGY.
82 2021-01-28 pain in extremity arm was sore for about 4 days, low grade fever at about 36 hours, some swelling and rash around the ... Read more
arm was sore for about 4 days, low grade fever at about 36 hours, some swelling and rash around the injection site, headache about 48 hours after injection. No symptoms after the soreness in arm subsided. Took ibuprophen for fever and pain, did not need or seek medical attention.
82 2021-01-31 tenderness touched the back of her ear, it was tender and very sore; feeling very tender on the gland; Lymphati... Read more
touched the back of her ear, it was tender and very sore; feeling very tender on the gland; Lymphatic glands, those were the ones that got swollen; Headache; Neck was hurting; swollen; Neck was hurting; swollen; dryness, felt it on lips; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on14Jan2021 at a single dose for COVID-19 immunization. Medical history included arthritis on clavicle, thorax and lumbar. The patient had concomitant medications (unspecified). The patient wanted to report the reactions occurred on 14Jan2021 for the vaccine she got; she got a headache, couple of hours later, her neck was hurting. So, she asked somebody that was with her to check and told her that it was swollen. She also had dryness, felt it on lips. The patient touched her neck and it hurts. It did hurt and it was swollen, the neck. They gave her Tylenol and Benadryl. So, it does help her sleep but the next day, she was not so much hurting. Just had headache. On 17Jan2021, when she touched the back of her ear, it was tender and very sore. It was not as bad as it was. The first day (14Jan2021), she was feeling very tender on the gland. Those were not swollen. Lymphatic glands, those were the ones that got swollen on 14Jan2021. She would like you to know the main cause, they looked and told her it is normal for the lymphatic glands to get swollen after the vaccine. So, the patient guessed that is what she got but she still had a lot of soreness in the back of her neck. Outcome of the event events headache and neck pain was not recovered while unknown for other events. Information on the Lot/Batch number has been requested.
82 2021-01-31 tremor, weakness Jan 31, About 1pm , diarrhea . 7pm-9pm shaking chills. Diarrhea at 7pm. Temp., 94.7 at 8pm / 97.0 at... Read more
Jan 31, About 1pm , diarrhea . 7pm-9pm shaking chills. Diarrhea at 7pm. Temp., 94.7 at 8pm / 97.0 at 9:30pm / 100.7 at 10pm. Normal by 9:30am Feb 1. Very weak about 10pm. Needed help to get out of bed and help walking. Condition improved overnight. Tired for lack of sleep first half of day. Feeling normal by 6pm Feb 1.
82 2021-02-01 weakness, seizure got the 2nd vaccine on Thursday and already had symptoms from 1st vaccine but became weaker, vomitin... Read more
got the 2nd vaccine on Thursday and already had symptoms from 1st vaccine but became weaker, vomiting, diarrhea. headache went to the ER Sunday . She was coherent just weak. Did Xray of stomach found out she had colitis , started her on antibiotics and admitted her and by the next morning She started having delusions, almost like having a seizure. on blood work her magnesium was low. She started retaining fluid. Thought maybe she had stroke but CT showed nothing. Now she doesn't know who she is and just repeating numbers. Pt is currently in the ICU. She has a feeding tube now do to not eating.
82 2021-02-01 weakness Chills, Fever, Breathing, Weakness, Headache. This started in afternoon 1 day after receiving vacci... Read more
Chills, Fever, Breathing, Weakness, Headache. This started in afternoon 1 day after receiving vaccine. Took 2 Tylenol 4 hours later took 2 Advil. Chills went away. Had a fever , but this morning it is gone. I have never had a reaction to any kind of vaccination before exept for a minor sore arm. If I had a reaction to the first one, should I have a reaction to the second does also?
82 2021-02-03 weakness, pain in extremity Patient presents to the ED with left leg myopathy leading to pain and subjective weakness making it... Read more
Patient presents to the ED with left leg myopathy leading to pain and subjective weakness making it difficult to ambulate
82 2021-02-03 pain in extremity pt states arm was itchy and sore after the injection. On 2/3/2021 she had severe chills and fatigue... Read more
pt states arm was itchy and sore after the injection. On 2/3/2021 she had severe chills and fatigue. Pt states she is feeling better today 2/3/2021 and has a regular appt w/ her PCP on 2/5/2021 and will discuss her symptoms.
82 2021-02-04 pain in extremity my arm started to hurt like someone was punching me in my arm/arm is very sore; had some itching/it... Read more
my arm started to hurt like someone was punching me in my arm/arm is very sore; had some itching/itching is in the upper and lower arm that she received the vaccine; lot of discomfort in her arm where she got the vaccine; injection site pain/she has had a lot of discomfort in her arm where she got the vaccine. She says it feels sore and hurts; lot of discomfort in her arm where she got the vaccine. She says it feels sore and hurts. She says for a while it was itching,; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 14Jan2021 09:30 at single dose (right arm) for COVID-19 immunization. The patient had no medical history and no concomitant medications. The patient reported that she received her 1st vaccine shot last Thursday, 14Jan2021. She initially had no problem, then a day or 2 later, her arm started to hurt like someone was punching me in my arm. She also had some itching in the upper and lower arm where she received the vaccine; the itching was worse, but now it was better. She also had a lot of discomfort in her arm where she got the vaccine. She says it felt sore and hurts and for a while it was itching, but it stopped itching, she has no rash, just her arm was very sore. Patient reported that she never got her vaccine card after she left the room where she was observed for 15 minutes, and when she asked, they said she won't get the card until after her second shot. She says that she saw on all of the directions for the vaccine it says to keep your card, but when she left the room they told her she won't get it until after her second shot. She confirmed she has only had her first dose. Patient reported that she had no other recent vaccinations or started no other new medications. Outcome of events was unknown. Information on the lot/batch number has been requested.
82 2021-02-07 feeling hot Redness and heat on R foot, left after 15 minutes. Upset bowel system. Have always had opposite pro... Read more
Redness and heat on R foot, left after 15 minutes. Upset bowel system. Have always had opposite problem.
82 2021-02-07 pain in extremity soreness of arm after first dose of covid vaccine; This is a spontaneous report from a contactable c... Read more
soreness of arm after first dose of covid vaccine; This is a spontaneous report from a contactable consumer (patient). This 82 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown) on 21Jan2021 via unknown route of administration at single dose on left arm for COVID-19 immunisation. Relevant medical history included back problems which was diagnosed prior to receiving the Covid vaccine and was treated with epidural injection with no side effects. Relevant concomitant medication were not provided. The patient reported that he received first dose of COVID-19 vaccine on 21Jan2021and experienced soreness of arm after first dose of COVID-19 vaccine. The outcome for other events was not recovered. The patient stated that she will receive her second epidural injection on 02Feb2021 but also reported that her second COVID-19 vaccine shot is scheduled for 11Feb2021. The patient inquired if there is any study, or danger in having the epidural shot and Covid shot close together or if she needs to space them apart. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
82 2021-02-08 seizure, unresponsive to stimuli Pt with seizure-like activity noted x2 by her husband, with symmetric jerking of legs, loss of respo... Read more
Pt with seizure-like activity noted x2 by her husband, with symmetric jerking of legs, loss of responsiveness, loss of bowel/bladder function.
82 2021-02-09 weakness Client verbalized feeling nauseous and weak. Client was evaluated by rescue and released to go home... Read more
Client verbalized feeling nauseous and weak. Client was evaluated by rescue and released to go home at 10 am.
82 2021-02-09 feeling jittery Client stated that she was experiencing sudden headache, jittery, and slightly lightheaded. She voi... Read more
Client stated that she was experiencing sudden headache, jittery, and slightly lightheaded. She voiced that the feeling of getting lightheadedness was not unusual but the sudden headache was. Pt was seen and assessed by EMT. VS as followed BP 150/89, HR 76, O2 97. Pt cleared by EMT to go home.
82 2021-02-09 pain in extremity Pain in her arm; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consume... Read more
Pain in her arm; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for herself that an 82-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain in her arm on 23Jan2021 and was wondering if she could take Tylenol for this since she heard that you're not supposed to take it as it may interfere with the vaccine. Patient stated that she couldn't find any information on the sheet given to her whether she could take Tylenol or not after getting the vaccine. The outcome of the event was unknown. Information about lot/batch number has been requested.
82 2021-02-11 weakness Fri 2/5/21 , 6 am teeth chattering, weak, nausea, tiredness, slight headache, light headed, extreme ... Read more
Fri 2/5/21 , 6 am teeth chattering, weak, nausea, tiredness, slight headache, light headed, extreme diarrhea (may be due to antibiotic) very slight soreness as injection cite. This lasted for 48+ hours. Did not feel myself for 72 hours.
82 2021-02-11 unresponsive to stimuli, weakness The individual received the vaccine around 12:00pm on 02/11/21. Around 9pm the individual went to la... Read more
The individual received the vaccine around 12:00pm on 02/11/21. Around 9pm the individual went to lay down on the couch at home and started to have difficulty breathing. Within 30 minutes the individual became week and unresponsive. She was transported to the hospital where she was pronounced deceased at 11:44 pm on 02/11/21.
82 2021-02-14 flushing Site: Redness at Injection Site-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Other- rash next ... Read more
Site: Redness at Injection Site-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Other- rash next to injection site-Medium
82 2021-02-16 involuntary muscle movements 1/22 8:000 PM had 3 jerks quick jerks of left arm, 1/23 around 11:30 when laid down on and off li... Read more
1/22 8:000 PM had 3 jerks quick jerks of left arm, 1/23 around 11:30 when laid down on and off little jerks from head to toe on and off. When I woke up around 8:30 could feel some. During day some little ones mostly arms or hands, once in a while legs, Monday 1/23 around 9:00 PM a hard jerk on left shoulder and at night kind of a hard one on left arm. Seemed to have seattled down to mostly subtle ones in hands or arms on and off. Legs feel kind of stiff or tight. Once in awhile felt pulsating through out, but that seems to have gone away. Mild pain feeling around shoulder blades on and mostly off. Never had before.
82 2021-02-18 pain in extremity 1st day sore arm, 4th day-stroke like reaction, had to go to er
82 2021-02-19 weakness There were no adverse reactions to the first dose, EL9261. In the hours immediately after the secon... Read more
There were no adverse reactions to the first dose, EL9261. In the hours immediately after the second shot, EN6200, there also were no reactions. However at approximately 1915 of the date of administration, several worrying effects presented, including; * strong headache * reaction site pain, though not redness * generalised weakness, but especially noticeable in legs * mild fever at 99.9 consistently for over 12 hours
82 2021-02-21 brain damage Patient was hospitalized, presenting to the ED with confusion/encephalopathy. She was also found du... Read more
Patient was hospitalized, presenting to the ED with confusion/encephalopathy. She was also found during her hospitalization to have hypoglycemia, CAP, UTI, and liver cirrhosis with elevated LFTs/ammonia. She was given antibiotics and lactulose to manage. Patient recovered and was later discharged
82 2021-02-23 flushing BODY FLUSHING, CHEST PAIN PATIENT EVAULATED BY EMS FOR 40 MIN VITALS STABLE AND SYMPTOMS RESOLVED
82 2021-02-23 pain in extremity Third day symptoms after first shot, extreme muscle pain , upper leg ,knee, foot, and groin! Pain l... Read more
Third day symptoms after first shot, extreme muscle pain , upper leg ,knee, foot, and groin! Pain level aroun 7 for two weeks ,on and off ,nights mostly. Pressure excellent the pain. Tylenol, Tramadole , no help. Dr visit on the 23 th , question of taking the second shoot.
82 2021-02-24 weakness Fever 101+ for two days, severe aches in hips and pelvis, loss of appetite, loss of energy which is ... Read more
Fever 101+ for two days, severe aches in hips and pelvis, loss of appetite, loss of energy which is continuing. Intestinal upset which is continuing.
82 2021-02-24 numbness Patient received vaccine on her left arm and was instructed to stay for 15 minutes per protocol. Aft... Read more
Patient received vaccine on her left arm and was instructed to stay for 15 minutes per protocol. After 5 minutes, patient complained of left arm numbness that radiated from injection area. patient was brought in to Minute Clinic for evaluation and after period of 10 minutes, complained of left leg numbness. Patient has history of high blood pressure, and high cholesterol. Minute clinic personel consulted with their MD after examination and patient was prefered to ER to rule out stroke. Physician assistant at Minute Clinic verified that shot was in proper placement. Pt was taken to ER by son.
82 2021-02-24 pain in extremity Dizziness, R side chest pain radiating to R side of neck and R arm. Evaluated by EMS, cleared.
82 2021-02-25 discomfort throat tightening; discomfort; little swelling; This is a spontaneous report from a contactable cons... Read more
throat tightening; discomfort; little swelling; This is a spontaneous report from a contactable consumer. An 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 26Jan2021 10:15 at single dose on Left arm for covid-19 immunisation. Medical history included has a lot of allergies, reactions to honey and penicillin, She experienced neck swelling after receiving penicillin. Caller took the 1st dose last 26Jan2021. she and her husband got the Covid-19 vaccine yesterday. While reporting on her husband, caller states she had a reaction to the vaccine. After receiving the shot, Caller was put on the side for half hour and 15 min later, she experienced her throat tightening on 26Jan2021. Caller was given Benadryl and observed for 10 min. Her husband received his shot but "he did not feel the needle going into his arm. Weight is between 120-123lbs. Caller mentioned that she has a lot of allergies. They watched her for 30 minutes after getting the vaccine. Within 15 minutes her throat was feeling a little tight. It cleared after about 10 minutes. Her vital signs were checked and were fine. Thy also gave her some Benadryl. She takes vitamins and minerals because she believes in them. Outcome of the event throat tightening recovered on 26Jan2021 and events was unknown.
82 2021-02-25 flushing Flushing/sweating. Benadryl 25 mg PO given. BP readings: 176/61 (pulse 78), O2 sat 100%; 173/71 (pul... Read more
Flushing/sweating. Benadryl 25 mg PO given. BP readings: 176/61 (pulse 78), O2 sat 100%; 173/71 (pulse 79), O2 sat 100%.
82 2021-02-26 tremor Patient developed sudden onset of right arm shaking at 6pm (19.5 hours after 2nd Pfizer vaccine). Th... Read more
Patient developed sudden onset of right arm shaking at 6pm (19.5 hours after 2nd Pfizer vaccine). The shaking originated at the injection site in right deltoid and radiated in shooting sensation down her right arm. Her entire body was shaking. She describes feeling "like I got the shakes and I couldn't control it." Felt like she needed to urinate (uses catheter) but no urine passed. Was unable to speak. Adult daughter was present. Event lasted approximately 30 minutes before gradually stopping. Took her temperature afterward and it was 99F. Slept very deeply that night, which is unusual for her.
82 2021-02-27 night sweats Early morning on 2/16 woke up disoriented and found myself lying on the floor in a hallway between b... Read more
Early morning on 2/16 woke up disoriented and found myself lying on the floor in a hallway between bedroom and bathroom. Not sure how I got there. Attempted to vomit but only gaged. Friend called at 700am and I wasn't making much sense. Later in the day I seemed alright, became cold in the evening and fever had returned. At 4 am morning of 2/17 I woke up soaking wet. Went back to sleep and seemed to be fine when I got up at 8am. It is now 2 weeks since I had this shot and I have experienced no further problems. My daughter-in-law Is a doctor and she said I should report these side effects.
82 2021-02-27 pain in extremity Redness on arm, painful and itching
82 2021-02-28 weakness Client proceeded to an upstairs restroom post-vaccination, rather than to observation area. Upon exi... Read more
Client proceeded to an upstairs restroom post-vaccination, rather than to observation area. Upon exiting rest room, client experienced weakness, mild light-headedness with elevated BP of 203/98. She was evaluated by paramedics on site who recommended further evaluation. Client declined stating she felt better and would take her medication when she arrived home. RN encouraged her to call her physician when she got home. A friend drove her home . A follow-up call was made at 1:46 p.m. by reporting RN. Client stated she took medication, was resting and BP was 168/70, and she was planning to call her doctor. She felt the episode was due to the exertion of going directly upstairs to the rest room, rather than sitting down in observation area.
82 2021-02-28 depressed level of consciousness My mom received the Pfizer Covid 19 vaccine on 1/4/21. On 1/12/21 I received a call from the nursi... Read more
My mom received the Pfizer Covid 19 vaccine on 1/4/21. On 1/12/21 I received a call from the nursing home that my mom had stopped eating and drinking and that she had nothing to eat or drink for 3 days. I asked them why they didn't call me sooner but they did not have an answer. I was told to come in because she was very lethargic and possible dehydrated. They tested her for Covid the morning of 1/12/21 and she tested negative. I went into see my mom and she was barely conscious. They gave her fluids intravenously but it had no positive affect on her condition. On 1/14/21 she tested positive for covid and was moved to their covid unit. I called in Hospice comfort care on 1/15/21. My. mom died on 1/17/21.
82 2021-02-28 flushing The patient reported feeling flushed. Vitals taken and noted to be hypertensive (76 pulse, oximetry ... Read more
The patient reported feeling flushed. Vitals taken and noted to be hypertensive (76 pulse, oximetry 100%, 198/90 BP). Rested 10 minutes and took vitals again (Pulse 77, BP 204/114). Patient reports taking her medications today as prescribed, but does not take BP regularly at home. RN present and assessing patient. Consulted with Dr. and recommended ED for assessment. RN took patient to ED.
82 2021-02-28 pain in extremity Immediately after receiving the vaccine, client started c/o severe pain in her arm and lightheadenne... Read more
Immediately after receiving the vaccine, client started c/o severe pain in her arm and lightheadenness and shallow breathing. vital signs monitored. no meds administered. Son at her side. This information was obtained from her son. He says she has bad arthritis and the shot hurt her and she almost passed out. She has had no other problems since and didn't have any with the first dose.
82 2021-02-28 pain in extremity About 3 hours after shot I got diarrhea and it was bad. Pain in arm, dizziness and loss taste and i ... Read more
About 3 hours after shot I got diarrhea and it was bad. Pain in arm, dizziness and loss taste and i have not gotten back yet, joint pain, tiredness, fever. I have been so thirsty i have been drinking a ton of water. i had all the symptoms of covid . I had covid in November and symptoms were worse .
82 2021-03-01 weakness, unresponsive to stimuli, speech disorder Systemic: Weakness-Severe, Additional Details: patient was unresponsive and staring blankly later th... Read more
Systemic: Weakness-Severe, Additional Details: patient was unresponsive and staring blankly later that evening after receiving the first dose of vaccine, she was not able to verbalize symptoms, however, she experienced weakness in legs requiring assistance to walk per her caregiver
82 2021-03-01 numbness, pain in extremity ARM PAIN-FATIGUED-NUMBNESS IN HANDS
82 2021-03-01 speech disorder gets 102 degree fever; Could not speak much next two days; Within one hour or so after: found on fl... Read more
gets 102 degree fever; Could not speak much next two days; Within one hour or so after: found on floor, fell on right side; unable to speak like a TIA; disoriented; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 at 13:00 at single dose for COVID-19 immunisation at the age of 82-year-old. Medical history included dementia, high blood pressure, allergy to drugs with sulfer. Concomitant medications included 2.5 Amlodipine, 81 mg aspirin, 0.5 clonazepam, 20 mg Escitalopram, 10 mg melatonin, 5 mg memantine, 15 mg mirtazapine. The patient was not pregnant. The patient received first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 at single dose for COVID-19 immunisation at the age of 82-year-old. Within one hour or so after the vaccine administration: the patient was found on floor, fell on right side, disoriented, unable to speak like a transient ischemic attack (TIA), out of it. The patient could not speak much next two days. Don 14Feb21 at 15:00, the patient got 102-degree fever. The patient was treated for the events. The patient was recovering from the events. Information on the lot/ batch number has been requested.
82 2021-03-02 breast pain Patient presented to ED with chest pain on her right breast radiating to the back intermittently. No... Read more
Patient presented to ED with chest pain on her right breast radiating to the back intermittently. No associated N/V, diaphoresis, or SOB. Pt was started on a heparin drip but was later discharged home after being cleared by cardiology. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
82 2021-03-02 muscle spasms upon rising from a sitting position my legs would not hold me up. I could not walk without someone ... Read more
upon rising from a sitting position my legs would not hold me up. I could not walk without someone helping to keep me from falling. My legs around the knees and lower thigh area were having spasms just momentarily. I went to bed, slept well and next day everything was fine. No pain associated with episode.
82 2021-03-02 slow speech, difficulty speaking, tremor, weakness 10:05 am Pt received vaccine and was seated in observation area. Pt alert, interacting with staff an... Read more
10:05 am Pt received vaccine and was seated in observation area. Pt alert, interacting with staff and other pts. 10:15am Pt appears asleep, rouses with touch and when spoken to. Observation area nurse notified, provided pt with bottle of water and helped her take a drink. Nurse then notified pharmacist who came to pt's side. Pt given 25 mg benadryl caplet. Able to swallow it, needed assistance for holding water bottle. Pt breathing regular, pulse regular and easily palpable. 10:25 Pt increasingly lethargic. Nurse and pharmacist with pt. Lips and tongue slowly swelling, responsiveness decreasing. Pharmacist called 911. 10:30am Pt's daughter administered epipen 30mg, L outer thigh. Swelling of lips and tongue quickly resolving. Pt lethargy increasing. Increasingly slow to open eyes and respond to questions. Pulse and breathing continue regular. EMS arrived on scene approx 10:35-10:40. BP 80/60, NSR, pulses palpable, pupils reactive, able to answer questions but slow to respond and weak voice. Pt transferred to Medical Center. In ER pt given IV solumedrol, IV fluids, CXR, EKG. Awake and oriented, arms shaking, weak, requires assistance to stand, intermittently drowsy. Admitted for observation. 3/3/21 pt preparing for discharge, BP extremely high. Pt given metoprolol, BP increased, tachycardia increased, pt very drowsy. Continued to monitor, given Lisinopril, bp decreasing. Pt feeling much stronger, alert, interacting with staff and daughter. Discharged home.
82 2021-03-04 weakness, muscle twitching 1/21/2021 During Covid 19 outbreak on the unit, resident contracted the virus. 1/21 MD updated on i... Read more
1/21/2021 During Covid 19 outbreak on the unit, resident contracted the virus. 1/21 MD updated on increased weakness, twitching, fatigue noted today. 2 rapid covid-19 tests done today, both negative. new orders cbc with diff, BMP, d. dimer stat and swab for covid and Influenza. 1/21-Covid and Influenza swab results received. PCR-Influenza negative, covid-19 positive. Palliative care updated. 1/21-Labs drawn cbc, BMP, d. dimer Results WNL. Temp 101.2 and Occ dry cough. 1/22 Palliative MD and APRN visited. Family preference for no hospitalizations, no IV's and do not intubate. DNR. Admitted to Hospice services on 1/25. 1/21-1/29. Symptomatic with lethergy, occ cough, off and on temp and began refusing meals and meds at times. 1/31 periods of apnea. 2/1 precautions ended for Covid 19. Continued with Hospice care and with ongoing refusal of meals, condition declining and comfort maintained. Meds slowly discontinued. Expired at facility on 2/18/2021.
82 2021-03-04 pain in extremity ache on her left arm; This is a spontaneous report from a contactable consumer via a Pfizer-sponsore... Read more
ache on her left arm; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. An 82-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date: 31May2021), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunisation. Medical history included breast cancer from 01Dec2020 to an unknown date. Concomitant medication included simvastatin and lisinopril. It was reported that she got her first dose on 23Jan2021 and she got an ache on her left arm and then she was originally scheduled for second dose on 13Feb2021, however though, she was rescheduled to have the second dose on 9Feb2021, that is 17 days earlier and she is worried about it and matter of fact is she will have an surgery of breast lumpectomy on 11Feb2021. So, her concern is if she can second dose early and or if it's okay to have the surgery prior the vaccination. The patient underwent lab tests and procedures which included weight: about 200 pounds (overweight) on an unspecified date. The outcome of the event was unknown.
82 2021-03-04 tremor, night sweats, weakness Covid Vaccine Chronology March 8 ? 16, 2020: Hospitalized with Covid-19 Virus. Health largely rest... Read more
Covid Vaccine Chronology March 8 ? 16, 2020: Hospitalized with Covid-19 Virus. Health largely restored to previous level February 25, 2021: Received first dose of Pfizer Covid Vaccine and noted a small red spot and small bump on the arm at the injection site February 26, 2021: Noted the following symptoms; Took Tylenol ? Arm swelling with the bump getting painful and redness expanding ? Very weak and body aching ? Chills and fever ? Headache and nausea February 27, 2021: Noted these symptoms: Took Tylenol ? Felt like I had the virus all over again with every bone aching ? Headache with fever of 100.5. ? Chills with shaking ? Loss of appetite ? Swelling in the arm growing larger with the bump feeling hard and more painful February 28, 2021: Noted these symptoms: ? Stomach hurt and thirsty took some Tums and drank water to relieve it ? Arm very red swollen and painful from shoulder to elbow. Pain in the bump close to level 10. Took pictures ? Still limited appetite ? Body aches ? Night sweats March 1, 2021: Noted these symptoms ? Arm still red, swollen and painful but area away from the bump becoming itchy tried ice but not very helpful ? Chills, fever and body aches dissipating ? Night sweats ? Thirsty ? Able to take a short walk outside March 2, 2021: Noted these symptoms: ? Woke up drenched in sweat ? Still very thirsty ? Labored breathing when we took a walk ? Tried heat and cold on arm which was still painful but the pain level had come down between 8 and 9 ? Saw Dr. who prescribed Traumeel to reduce the redness and swelling in my arm and told me she would do more research but at this point not to take the second dose of the vaccine after hearing my symptoms March 3, 2021: Noted these changes ? Arm still swollen and red with the bump still painful but closer to a 6 or 7. ? Saw my chiropractor, who gently massaged my body back into alignment and showed me some massages for my arm ? Was able to take a walk and the breathing was improved
82 2021-03-08 weakness Fatigue, head ache, dizziness, feeling weak
82 2021-03-08 pain in extremity Patient's family concerned regarding increased confusion and arm pain post covid vaccination. Insist... Read more
Patient's family concerned regarding increased confusion and arm pain post covid vaccination. Insistent that an adverse event form completed. Resident had covid-19 in November 2020, then a uti, and CHOLELITHIASIS WITHOUT OBSTRUCTION right before the vaccine series started.
82 2021-03-10 breast pain I received vaccine on Friday 02/19/2021 , Saturday woke up with rash on back and pain under left bre... Read more
I received vaccine on Friday 02/19/2021 , Saturday woke up with rash on back and pain under left breast went to doctor 02/23/2021, they prescribed cream Triamcinolone Acetonide Cream 0.5%. then went back Monday 03/08/2021 they prescribed Valacyclovir gram every hours for 21 pills and Gabapentin for the pain for what they called shingles .
82 2021-03-11 weakness Vaccine recd 1/20 and 9 days after I got really sick and still having breathing trouble and short of... Read more
Vaccine recd 1/20 and 9 days after I got really sick and still having breathing trouble and short of breath, now using breathing treatments, I'm having a hard time walking, weakness all over, headaches, and I feel so out of it.
82 2021-03-14 flushing had reaction in mouth broke out in tiny sores; Facial flushing; This is a spontaneous report from a ... Read more
had reaction in mouth broke out in tiny sores; Facial flushing; This is a spontaneous report from a contactable consumer reporting for herself. An 82-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration from 08Jan2021 to 08Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included hypertension, blood pressure abnormal, blood cholesterol increased, thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included triamterene (TRIAMTERENE), verapamil (VERAPAMIL), levothyroxine (LEVOTHYROXINE), atorvastatin (ATORVASTATIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Caller stated that she had her first Pfizer vaccine on 08Jan and was scheduled for her second one tomorrow. Stated that the next day in the evening that she had a reaction in her mouth that broke out in tiny sores. Stated that she went to her dental appointment and was prescribed Triamcinolone Acetonide paste and it went away. Wanted to know if this is anything that has been reported before she gets the second one. Clarified it as Pfizer Covid 19 vaccine. Is in her 80s. Stated that she also had facial flushing in 15 minutes of the vaccine that went away in 30 minutes. Concomitant Medication: Stated that she was on her regular medication. Littles sores in the roof of my mouth, dentist checked and said that sometimes vaccine can trigger like you have had cold sores or canker sores in the past. Consumer stated, "I spoke with someone earlier today and went through some side effects I had from the first Pfizer vaccine which was 08Jan. And we went through everything and she said I needed to report to someone else, a nurse or something and I decided to get back to that, she said option 3 but when I went to option 3 it was Medical, I don't know if I put the option in too soon or what. All I want to do is just report and I am having my second dose in the morning. When probed for the reference#, consumer stated, She didn't give me a reference number, but I gave her the COVID Vaccine Pfizer LOT and also gave her my email.Role of Pfizer Drug Safety was informed to the consumer. When probed for the adverse reactions, consumer stated, "I had facial flushing at the time. They had me stay for half an hour and check blood pressure and everything and then the following night I had some littles sores in the roof of my mouth and I already had a dental appointment coming up, so I went to the dentist and he checked it and said that sometimes the vaccine can trigger like you have had cold sores or canker sores in the past. Ethnicity: Consumer stated, "(Withheld) with some (withheld). Consumer confirmed vaccine name as COVID-19 Vaccine When probed for the expiration date, consumer stated, "No, but I am having a second one tomorrow. I was given at (Institute name). Other medical conditions: Consumer stated, "I have thyroid." (Not clarified further). When probed for the treatment, consumer stated, "The only treatment I had is the dentist prescribed a paste that I dab on, that I put in my mouth, but it took care of the problem I used it about five days. Consumer further stated, "My main thing was just reassurance that those can be normal because it is not listed in the side effects. I have been on phone now for at least an hour waiting my turn. I think I will go and just tell them tomorrow when I get my shot. Consumer stated, "I spoke with someone earlier today and went through some side effects I had from the first Pfizer vaccine which was 08Jan. And we went through everything and she said I needed to report to someone else, a nurse or something and I decided to get back to that, she said option 3 but when I went to option 3 it was Medical, I don't know if I put the option in too soon or what. All I want to do is just report and I am having my second dose in the morning. When probed for the reference#, consumer stated, "She didn't give me a reference number, but I gave her the COVID Vaccine Pfizer LOT and also gave her my email. Role of Pfizer Drug Safety was informed to the consumer. When probed for the adverse reactions, consumer stated, "I had facial flushing at the time. They had me stay for half an hour and check blood pressure and everything and then the following night I had some littles sores in the roof of my mouth and I already had a dental appointment coming up, so I went to the dentist and he checked it and said that sometimes the vaccine can trigger like you have had cold sores or canker sores in the past. Consumer confirmed vaccine name as COVID-19 Vaccine. Consumer further stated, "My main thing was just reassurance that those can be normal because it is not listed in the side effects. I have been on phone now for at least an hour waiting my turn. I think I will go and just tell them tomorrow when I get my shot. Consumer was provided with Pfizer Medical Information Department's number as (Phone number withheld) and was informed to press option 3 and call from 8 AM to 11 PM, Mon to Sun as per EST. Outcome of the events was recovered. The reporter considered the events as non-serious.
82 2021-03-14 tingling, burning sensation elevated blood pressure; a sensation of tingling on the right side of her chest and her right arm; b... Read more
elevated blood pressure; a sensation of tingling on the right side of her chest and her right arm; burning sensation in my chest and right arm; felling dizzy/light-headed and "crummy"; This is a spontaneous report received from a contactable consumer (patient herself) via a Pfizer sponsored program Pfizer First Connect, and via Medical Information Team. An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number was not reported), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Medical history included cancer and blood pressure issues (she had been treated prior to vaccination). The patient's concomitant medications were not reported. It was reported that, the patient received her first dose of Pfizer-Biontech Covid19 vaccine on 27Jan2021. She has since been feeling dizzy, light-headed and "crummy" in Jan2021. She reports going to the ER (emergency room) yesterday morning (08Feb2021) reporting an elevated blood pressure, with dizziness and a sensation of tingling on the right side of her chest and her right arm (the same arm that was vaccinated). Her MD says that she should not take the second dose, but her daughter-in-law who is a nurse says that it is her (the patient's) decision. On 27Jan2021, patient had been having issues with her blood pressure- sent to the ER yesterday morning- blood tests twice already. BP elevated and dizzy because she had a burning sensation in her chest and right arm in 2021. The patient supposed to get second dose on Wednesday doctor says not to take it, since she was experiencing adverse event, and her HCP sited the deaths in as a reason for her not to receive the second dose. The outcome of the events was reported as unknown. Information on the lot/ batch number has been requested.
82 2021-03-15 weakness king size belly ache; pooped all over herself; weak and too through; severe diarrhea; This is a spon... Read more
king size belly ache; pooped all over herself; weak and too through; severe diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reported) via medical information team. A 82-year-old female received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262, expiry dates not provided, NDC#; unknown), via an unspecified route of administration, in arm left, on 27Jan2021 14: 00, as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were none. It was reported that the patient experienced severe diarrhea on an unknown date in 2021, also reported that She got a king size belly ache the following Saturday and pooped all over herself. She is weak and too through; all events on 30Jan2021. The outcome of the event diarrhea was unknown and other events were recovering.
82 2021-03-15 pain in extremity, tenderness Pain for 4 or 5 days in left leg (that leg also has varicose veins), some swelling and tender to th... Read more
Pain for 4 or 5 days in left leg (that leg also has varicose veins), some swelling and tender to the touch . Fifth day became raised and warm to the touch, so went to Urgent Care Diagnosis: Occlusive and nonocclusive thrombus within a superficial vein underlying the region of concern
82 2021-03-16 unresponsive to stimuli Family call Clinical Lead to car for elderly woman in backseat of car who had become unresponsive. ... Read more
Family call Clinical Lead to car for elderly woman in backseat of car who had become unresponsive. Patient lying on side. Wearing portable NC o2. Unresponsive to verbal/sternal rub. No pulse, No resps. Called AMR to car side who called 911. Transferred patient to a gurney and began CPR as we transferred to AMR rig. EKG - showed PEA - CPR continued - patient intubated by AMR - epi is given. Pt transported by AMR/Fire to hospital. Pt was a full code on Hospice - she passed away 3/11/21 with the following cause of death: 1.Acute-on-chronic hypoxemic/hypercarbic respiratory failure, multifactorial in origin. 2. Possible aspiration pneumonia, present on admission. 3. Bronchiectasis, chronic, secondary to asbestosis. 4. Acute combined metabolic and toxic encephalopathy, present on admission. 5. Out of hospital pulseless electrical activity arrest. 6. Hyperkalemia. 7. Cardiogenic shock. 8. Acute kidney injury. 9. Lactic acidosis. 10. Acute diastolic congestive heart failure. 11. Severe protein-calorie malnutrition.
82 2021-03-17 weakness Date and time of vaccination: (list both if they received both shots): 02/18/21 no time indicated, ... Read more
Date and time of vaccination: (list both if they received both shots): 02/18/21 no time indicated, face broke out with a rash (doctor gave her prednisone shot) 03/09/21 5 days later face broke out with a rash, a light circle rash around the injection site stated she felt weak Brand and lot of vaccine: Pfizer Lot 1# EN6198 Lot 2# TN6206 Doctor gave her prednisone to alleviate her symptoms
82 2021-03-18 muscle spasms States she had mild Charlie horses in her legs and hands starting 7 days post vaccination with the 2... Read more
States she had mild Charlie horses in her legs and hands starting 7 days post vaccination with the 2nd dose of Pfizer. On day 9 post vaccination she developed these Charlie horses in her ribs and arms and legs stating she felt like she was on her way out. Did not take any meds not went to the doctor for the symptoms. Started taking calcium/zinc product and as of today she states she is well. She just wanted someone to talk to about the side effect and make sure this was documented
82 2021-03-18 numbness and pain in extremities woke wet from sweat; Nausea; neuropathy was elevated to an unbearable level /neuropathy flared up; b... Read more
woke wet from sweat; Nausea; neuropathy was elevated to an unbearable level /neuropathy flared up; body aches; severe muscle ache; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's daughter-in-law). An 82-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date) at 82-year-old vaccination age via an unspecified route of administration in the right arm on 11Feb2021 15:30 as a single dose for covid protection (covid-19 immunisation). Medical history included transient ischaemic attack (TIA) which she has had this happen twice, thyroid removal in 1970, stroke (last doctor screwed up her medications and could have caused a stroke), has been losing a lot of weight (prior to vaccination) and neuropathy. Concomitant medications included influenza vaccine (FLU) on an unspecified date for an unspecified indication, blood pressure medicine, and hormone medication since she had her thyroid removed in 1970. The patient did not receive vaccinations within 4 weeks prior. The reporter mentioned that the patient has experienced body aches on 12Feb2021, nausea on 13Feb2021 and she woke wet from sweat on 16Feb2021. It was mentioned that her neuropathy was elevated to an unbearable level on 12Feb2021. She didn't feel it the first day. When talking about the neuropathy, the reporter stated that it was like something stabbing her from the knees to the toes. She has to lay in bed. Her legs hurt so bad she is unable to stand and can't sit for long. She woke wet with sweat twice. The first time was on 16Feb2021 and again on 19 or 20Feb2021. She had a flu shot on an unspecified date when they came out. The events did not require emergency room or physician's office visit. The reporter mentioned that her mother in law who was due tomorrow for the second dose and wanted to cancel because their doctor advised them to wait for at least a month to receive the second dose. According to her, her mother in law was sick for almost 3 weeks after the first dose, her mother in law experienced severe muscle ache and her neuropathy flared up on an unspecified date in 2021. The outcome of the events sweaty was recovered on an unspecified date in 2021, as for the event nausea was recovered on 01Mar2021 while muscle ache was unknown. The outcome of the other events was recovering. The following information on the batch/lot number has been requested.
82 2021-03-18 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer (Patient's husband) via a sponsor... Read more
Sore arm; This is a spontaneous report from a contactable consumer (Patient's husband) via a sponsored program. An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), the patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNONW), both via an unspecified route of administration on unspecified dates (at the age of 82 years); both as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The husband reported on behalf of his wife who got the first and the second dose of the vaccine, and she experienced sore arms after the vaccine. The clinical outcome of sore arm was unknown. Information on the lot/batch number has been requested.
82 2021-03-20 feeling cold, tremor she has been freezing since receiving her second COVID-19 Vaccine dose; She said the last 2 days she... Read more
she has been freezing since receiving her second COVID-19 Vaccine dose; She said the last 2 days she has been very nauseous. She said she was nauseous all day Thursday, 04Feb2021; Chills; Shaking; She clarified she is always cold, but her coldness seems to be worse at night.; This is a spontaneous report from a contactable consumer. A 82-Year-old female consumer receive second dose of COVID-19 Vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,lot no: EL9262, formulation; solution for injection), via an unspecified route of administration on 03Feb2021, 10:30AM as single dose at arm left for covid-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot no: EL1284) on Jan2021 for covid-19 immunisation. The patients' Medical history included Partial knee replacement on 16Nov2020, ongoing Diabetes and Spinal stenosis. The patients concomitant medication was not reported.On 03 Feb 2021, the patient had been freezing since receiving her second COVID-19 Vaccine dose, she was nauseous all day , had chills and was shaking. The patient took Extra Strength Tylenol 500mg. the outcome of event shaking was not recovered, chills and nausea was recovered on 03 Feb 2021.
82 2021-03-22 pain in extremity, speech disorder, unresponsive to stimuli, tremor dizziness; hallucinations; disorientation; fever/she had fever again; pain in the arm/pain in left a... Read more
dizziness; hallucinations; disorientation; fever/she had fever again; pain in the arm/pain in left arm; loose appetite/without appetite; forgetting things and words; could not even put up a sentence; difficulty breathing; needed help to walk; needed help to get dressed and eat due to hands tremor issue; vomiting; pneumonia; stopped eating; she was always tired; sleepy; stiffness in extremities; oxygen was low; she was not responsive/following instructions; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Feb2021 08:45 on Left arm at single dose for COVID-19 immunization. Medical history included Hypertension. Concomitant medications included acetylsalicylic acid (ASPIRIN PROTEC), atorvastatin, losartan. The day of the vaccine administration she had fever and pain in the arm on 14Feb2021 20:00, next day on 15Feb2021 started with dizziness, hallucinations, disorientation. As the days went on in 2021, she started to loose appetite, forgetting things and words, she could not even put up a sentence but most importantly she had difficulty breathing, needed help to walk, get dressed and eat due to hands tremor issue. Afterwards; she had fever, vomiting, pneumonia and stopped eating, she is always tired, sleepy, with stiffness in extremities and pain in left arm. She was 1 day hospitalized and we had to bring her back to hospital because her oxygen was low, she had fever again, without appetite and she was not responsive/following instructions. All events were resulted in Emergency Room Visit and Physician Office Visit, Hospitalization for 1 day. Treatment received for the events included Oxygen, fluids, antibiotics. Lab data also included covid test type post vaccination=Nasal Swab on 01Mar2021 with Negative result. The outcome of the events were not resolved. Information on the lot/batch number has been requested.
82 2021-03-22 tremor Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemi... Read more
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: pt was very anxious -Severe, Systemic: Shakiness-Severe, Additional Details: after pt received her shot she shopped in the store and then sat down and was very anxious, dizzy, and was shaking uncontrollably
82 2021-03-23 involuntary muscle movements jerks left arm next day, next day small jerks fr head to toe at night. have lessened but still minor... Read more
jerks left arm next day, next day small jerks fr head to toe at night. have lessened but still minor jerks especially arms and hands; stiffness in legs and back; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient (not pregnant) received BNT162B2 (lot number: em9809) second dose on 10Feb2021 10:30 at single dose on left arm for COVID-19 immunisation. Medical history included sleep apnea. Concomitant medications included lisinopril, acetylsalicylic acid (BABY ASPIRIN) and paracetamol (TYLENOL). The patient had allergies to Levaquin. The patient previously took BNT162B2 (lot number: el9261) first dose on 20Jan2021 (at the age of 82-year-old) on right arm for COVID-19 immunisation. Facility type vaccine was Hospital. Jerks left arm next day, next day small jerks from head to toe at night. have lessened but still minor jerks especially arms and hands. stiffness in legs and back. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. No treatment. No covid prior vaccination. No covid tested post vaccination.
82 2021-03-24 discomfort blood clots right nostril; pain/discomfort right side at waistline going toward back; pain/discomfor... Read more
blood clots right nostril; pain/discomfort right side at waistline going toward back; pain/discomfort right side at waistline going toward back; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Lot Number: EL9581), as single dose in left arm on 06Feb2021 10:30 for COVID-19 immunisation, administered at hospital. Medical history included artificial mitral valve. No known allergies. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received concomitant medications in two weeks but were not reported. No other vaccine in four weeks. The patient received the 1st dose of bnt162b2 (BNT162B2), on ana unknown date for COVID-19 immunisation and experienced pulsatile tinnitus right ear. The patient experienced blood clots right nostril, pain/discomfort right side at waistline going toward back on 16Feb2021. The patient was hospitalized for blood clots right nostril. She went to Dr. for tinnitus, had MRI and CAT scan in 2021. All tests were negative. She received no treatment. COVID was not tested post vaccination. Right side got better after several days in 2021. Blood clots in nose lasted one morning and recovered on 06Feb2021.
82 2021-03-24 brain damage admit 2/20, vaccine 1/15, 2/9. COVID+ at NH week prior to admit, acute encephalopathy, FTT, likely d... Read more
admit 2/20, vaccine 1/15, 2/9. COVID+ at NH week prior to admit, acute encephalopathy, FTT, likely d/t COVID. Palliative care + DC to hospice per family's wishes.
82 2021-03-24 feeling cold Got her vaccine, came home drove herself, had no problem whatsoever, felt perfectly fine during the ... Read more
Got her vaccine, came home drove herself, had no problem whatsoever, felt perfectly fine during the day. She then went out, got lunch, brought it home, nothing about the day was out of the ordinary other than the vaccination. She often stays up too late and watches TV in her recliner and falls asleep. She guesses she didn't put things away properly, and the next thing that she remembers was going into the bathroom to get ready for bed, extremely cold evening. She then remembers when she went to hang up fuzzy robe up in the bathroom on a hanger on the doorway, and when she reached up just at that moment she felt herself falling/passing out. She does not remember the moments before or after the event. She fell over her bathtub that was in the doorway, and remembers the pain of hitting the tub. The next thing she remembers is like she was in a dream, and remembers thinking that she had to call her son as she knew she was in trouble. She does not remember dialing his # at that point, but her memory tells her that she told him that she needed him. She was told that was her 2nd call and she does not remember that. She remembers thinking at some point that she was coming in and out of consciousness, and remembers her son didn't come. She called 9-1-1 and remembers talking to somebody and telling them that she could not get up. She answered that she had her door unlocked and remembers that, and apparently told them that she could not stand up. She remembers crawling, possibly to the front door to unlock it. She also remembers telling the 9-1-1 person to tell the sirens off when they get to the neighborhood. They came and took her to the hospital, but doesn't remember that but then suddenly felt like she was freezing, and asking for a blanket, and asked if somebody opened a door. She does not remember the ride to the hospital, going out of her house, just being so cold she was hurting. She doesn't remember anything whatsoever of being in the ER, running tests. They apparently did 2 CAT scans and 2 MRI's, with and without contrast on both. The ER report said that when they got her that she was having extreme chills, and in a stroke-like condition, she could not see and she could not move her body. No tests indicated that she had a stroke. She doesn't think any of them knew that she had the vaccine, they only knew she was a heart patient, and looking for the stroke by doing typical stroke tests. She apparently had called her son first and told him that she was going crazy, and he called his sister, and then she called him again and said that she needed help, and didn't understand what she was talking about. She had no temperature she was told when they took her to the hospital. At some point she then started to spike her fever, which went up to 103. The next clear memory she has is that she woke up on Sunday in the hospital in a pool of sweat after her fever had broken. She also has a memory that she woke up and somebody was touching her in her privates, and there was somebody trying to catheterize her. At first she didn't understand why and then had a vague memory of trying to get a bedpan under her, and decided to catheterize her. She then back to sleep and woke up on Sunday and was completely waking up then and saw her son sitting there. All memories other than this was vague and in and out. After she was awake on Monday they came and did an EEG of her brain, it was normal. She then was given speech therapy on Sunday afternoon, had 10 questions, and answered 9 of them, but on one of them she told them that she could not do that, and did it the next day again and was able to complete that test. When she fell and hit the bathtub she did hurt her arm from her elbow to halfway toward her wrist. Then they discharged her home with someone with her 24 hours a day and could not drive or use the stairs until she had been seen by her family doctor in a week or two to make that she was safe. She had home health care coming in and PT had been coming as well. She had home health still as of yesterday 3/25/21, and PT discharged her as of yesterday. She has been by herself, and is OK to use the stairs and driving again. She has one more home health nurse visit for them to sign off and say that she is now OK. She did get her 2nd vaccine, and she had minor issues, a weird feeling in her head for 12 hours, but nothing bad enough to take something for it. It was a little uncomfortable and out of the norm for about a day, and at one point the next afternoon was making a sandwich and had something that went through her body and felt like she was going to pass out and got into her recliner. She laid down for about 15-20 minutes, it passed and she has been fine. She had somebody stay with her for 24 hours and has done well since. She is convinced that this reaction did come from the vaccine, and that the first vaccine can cause adverse reactions, and that she does live alone and never occurred to her that she needed somebody to stay with her, and now she is afraid to be alone.
82 2021-03-28 feeling hot, burning sensation Severe ringing in ears was followed by burning sensation starting in abdomen, then to legs and then ... Read more
Severe ringing in ears was followed by burning sensation starting in abdomen, then to legs and then to upper body. This happens every night about one hour after sleep. I have no fever. But I feel like I am in an oven. Subsides about one hour later but extreme tinnitus continues. During the day I feel hot but not the same intensity of the nightly attacks. Never had this before. I had a second shot on 2/26 and on that night it was very severe. Still suffering to this date. Primary doctor does not know what I have. Blood work negative except for two positive Ana antibody tests.
82 2021-03-30 weakness overwhelming feeling of dizziness/she felt the sudden urge to faint and then became so dizzy that sh... Read more
overwhelming feeling of dizziness/she felt the sudden urge to faint and then became so dizzy that she had to lie down on the couch; very weak; very tired; she has slept a lot; she felt the sudden urge to faint; unable to visually focus, if she closed her eyes and she opened one eye it would be blurry and the people on TV were sliding off the screen and everything was sliding away; pain behind her left eye into her head; she tried to get up to go to the bathroom the room was spinning; an inner ear problem or problems with the "crystals in her ear"; When she got up, she couldn't put her two feet on the floor out of bed without leaning towards the left; This is a spontaneous report from a contactable consumer (patient). An 82-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200) via an unspecified route of administration, administered in Arm Left on 01Mar2021 11:00 as SINGLE DOSE for covid-19 immunisation, at 82 years old. Medical history included history of a stroke from an unknown date (previous history of a stroke 19 months ago). There were no concomitant medications. The patient previously received BNT162B2(Lot# EW5318) on 07Feb2021, at 82 years old for COVID-19 immunization and experienced no adverse event (no reaction). Other historical vaccine included Flu shot (influenza vaccine) on an unspecified date and experienced almost killed her. The patient reported no reaction and no problems (no pain, no nausea, no anything) from the second dose until the evening of 08Mar2021 when she was in her kitchen cooking and chopping vegetables, she felt the sudden urge to faint and then became so dizzy that she had to lie down on the couch. She had an overwhelming feeling of dizziness. A feeling like she wanted to faint, and she never faints. Her daughter got her to the sofa. She couldn't get off the couch. The room spun unbelievably. Everything spun. She went to bed and when she woke up, she felt worse. She states that the dizziness was worse, she was unable to visually focus, if she closed her eyes and she opened one eye it would be blurry and the people on TV were sliding off the screen and everything was sliding away, and she had pain behind her left eye into her head. When she tried to get up to go to the bathroom the room was spinning. It lasted through the next day (09Mar2021). When she got up, she couldn't put her two feet on the floor out of bed without leaning towards the left. She didn't fall. It was so bad she had to grab onto things to walk. During that day they brought her downstairs and she stayed on the sofa and it just got worse. Her daughter had her call her primary care doctor and he said that if her neurologist had heard any of what had happened, then go to the emergency room, to which is where she was 19 months ago with her stroke. She spent the 11Mar2021 and 12Mar2021 in hospital (due to dizziness). They couldn't find anything. She had not had a new stroke. She had every test known to man. They did a full neurological work up including an MRI, CT Scan, carotid artery studies and checked everything and could not find the cause of her extreme dizziness. They did confirm that she did not have a stroke. The told her that she could potentially have an inner ear problem or problems with the "crystals in her ear" which could be causing her dizziness, however, they could not positively identify the cause of her problem. They found evidence of her previous stoke. When they were sending her home, it says on her discharge paperwork, they were going to put her in a vestibular clinic. It has to do with crystals in her ear. She was still dizzy and still walking with a walker which she hasn't had to use in 19 months since her stroke. And she has slept a lot, the night she was discharged on 12Mar2021 and the following day. On 14Mar2021 she woke up a little bit. But on 15Mar2021, she is very tired and very weak and still very dizzy. The dizziness is not the room revolving kind. She is taking an anti dizzy pill. She has to see her doctor tomorrow morning, her neurologist at hospital. The dizziness is still persisting but not as bad and she can jump up and walk and do things with the walker. Regarding tests done at the hospital, she came out with shining colors apparently. All tests came through fine. There was no evidence of stroke, her blood pressure, triglycerides, fluids or liquids, everything tested perfect. When querying if she had gone to her physician's office, she reported she had a morning call with her doctor on a phone appointment and he sent her straight to the hospital. She is still dizzy and walking with a walker which she has not had to use in 19 months. She states that doing a lot of hand-eye coordination exercises at home. She has the television on to check her vision which seems to be returning to normal. She stated, "I just don't know where to go from here." She stated that she has a follow up appointment the following day with her neurologist. She wanted to know if this side effect has been reported and how long she can expect to feel this way. The patient underwent lab tests and procedures on Mar2021 which included blood pressure, triglyceride, fluids or liquids: tested perfect; and CAT scan, EKG had unknown results. On 11Mar2021, CT Scan: unknown results (could not find the cause of her extreme dizziness. They did confirm that she did not have a stroke/they could not positively identify the cause of her problem); MRI: unknown results (could not find the cause of her extreme dizziness. They did confirm that she did not have a stroke/they could not positively identify the cause of her problem). Therapeutic measures were taken as a result of overwhelming feeling of dizziness and unable to visually focus. Outcome of the event dizziness was not recovered; outcome of the event unable to visually focus (visual disturbance) was recovered on an unspecified date in Mar2021; while room was spinning (spinning sensation) was recovered on 09Mar2021, while unknown for the other events.
82 2021-03-30 burning sensation She has not been feeling right; she does not feel normal/ Fuzzy head; she feels very sick; She feels... Read more
She has not been feeling right; she does not feel normal/ Fuzzy head; she feels very sick; She feels like her symptoms from her thyroid have like over taken her body; She feel like everything is aching, everything hurt; everything burns; It's hard for her to have her balance; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), via an unspecified route of administration at the age of 82 years, on 07Mar2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included ongoing thyroid disorder. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for covid-19 immunization. The reporter stated, "I am a daughter for patient who got the Pfizer shot". On an unspecified date, the reporter further stated, "I am calling in regards to my mother, she is 82 years old and she got her second vaccine on the 7th, on the Sunday and ever since then, she has not been feeling right, she has a condition where she has too many antibodies for her thyroid, but the first shot she got she felt fine after. This time she feels like her symptoms from her thyroid have like over taken her body and she feels very sick, she does not feel normal, she feel like everything is aching, everything burns, everything hurt, her head is fuzzy, it's hard for her to have her balance, it's only after she got the second shot she started feeling like that, the next day Monday, so we don't know what to do because we don't know how long will this last, she feels like she is dying, which is lot for my mom to say because she can take some pain, so I want to know the way this functions." The outcome of the events was unknown.
82 2021-03-30 pain in extremity, feeling cold severe chills; muscle aches; fever; arm "a little sore"; freezing to death; she is very tired; joint... Read more
severe chills; muscle aches; fever; arm "a little sore"; freezing to death; she is very tired; joints bothering her; This is a spontaneous report from a contactable Consumer (Patient) via Medical information team. An 82-year-old female patient received the first dose of bnt162b2 (BNT162B2, Pfizer-BIONTECH covid-19 vaccine, Formulation: Solution for injection, Lot number: EN9581, Expiration date: May2021, NDC number was not provided) via an unspecified route of administration, in arm right on 06Feb2021 18:00 as single dose for covid-19 immunisation. Medical history included thyroid condition and covid-19 from 29Jun2020 to an unknown date. Concomitant medication were not reported. Patient got 1st dose of vaccine on 06Feb2021. After dose experienced severe chills, muscle aches on 07Feb2021, fever, arm "a little sore", "freezing to death" on Feb2021, patient says, "the same symptoms like I had covid" patient tested positive for covid 19 in Jun, antibodies present before vaccine (in Dec). Patient was calling about the Covid 19 Vaccine. She had the first shot on Saturday at 6 o clock. She then woke up at like 3 or 4 in the morning with severe chills. Patient states that she had covid back Jun2020, on 29Jun2020 she was diagnosed as positive, she took herself to the hospital. She recalls getting the test 4 days later. The back around Christmas 2019 she a lot of similarities to it. After 4 days she recalls during a weekend she got sick. She recalls going on a Monday to get her test done, it did come back positive, she served her time, and proceeded to get better. Patient confirms that her First Dose of the covid vaccine was on Saturday 06Feb2021 at 6PM. Then at 3 or 4AM on 07Feb2021 she began to notice chills. Patient has the side effect list she had all of them, on Sunday she just slept all day long, her back and head was killing her, patient states that it felt as if she had covid again, patient experienced the same symptoms as when patient had covid. Patient no longer has the severe chills, that was Sunday into Monday. Patient then clarifies that she did not mean her back and head killing her, its more muscle aches and joints bothering her, and patient had a fever, patient is not having muscles aching at the moment, it normal very minimal, she is very tired on Feb2021. Patient second dose is on 27Feb2021. Patient takes a thyroid pill but doesn't know what name of her thyroid condition is. patient blood pressure is good. Patient explains that back in Jun2020, she was Sick for 4-5 days she then took a covid test, tested by Nasal Swab and then got the results the next day. 29Jun2020 is the day of the test, on the same day she went to the hospital but got sent home in 6 hours. In Dec2020 she had a positive antibody covid test. The outcome of the event severe chills was recovered on 08Feb2021, muscle aches was recovering and unknown for other events.
82 2021-04-03 weakness 4 a.m. 2/25/21, 1-degree fever lasting 4 days, swollen face 1 hour, joint pain first day, weakness 1... Read more
4 a.m. 2/25/21, 1-degree fever lasting 4 days, swollen face 1 hour, joint pain first day, weakness 10+ days, diarrhea for 3 days starting 1 week after shot,
82 2021-04-04 weakness She developed widespread hives that have lasted for two weeks, prolonged debilitating fatigue and we... Read more
She developed widespread hives that have lasted for two weeks, prolonged debilitating fatigue and weakness that have left her unable to participate in her life. 15 days later she is still struggling with shortness of breath and extreme fatigue and hives.
82 2021-04-12 burning sensation Burning sensation throughout body, fatigue, elevated blood pressure occurring within 30 minutes of v... Read more
Burning sensation throughout body, fatigue, elevated blood pressure occurring within 30 minutes of vaccine administration
82 2021-04-12 numbness Numbness in right hip/leg that continues as of April 13, 2021 Walking & Kneeling hard , afraid of f... Read more
Numbness in right hip/leg that continues as of April 13, 2021 Walking & Kneeling hard , afraid of falling.
82 2021-04-13 facial pain COVID Vaccine I got my #2 Pfizer last Tuesday Apr 6....no problem at all with #1. The vaccination ... Read more
COVID Vaccine I got my #2 Pfizer last Tuesday Apr 6....no problem at all with #1. The vaccination was in my LEFT arm, and the 1st day or so I didn't really have anything but tiredness. But the last few days have been very painful. I developed swelling on the RIGHT side of my face starting at the temple. That progressed down to the ear area the next few days and was quite painful. Since Saturday my tongue, lips, gums became swollen resulting in barely being able to swallow. Also rash developed and is getting worse. Additionally I ache all over and feel like a very bad case of the flu. I tried Tylenol Extra Strength in the beginning, but that seemed to only ease the pain for about an hour. Now I'm using Advil, which helps for several hours. Is there anything I can do to get relief. This is the 8th day....and it seems to be getting worse instead of better.
82 2021-04-13 feeling jittery Called in to assess patient. Per daughter, " she was feeling jittery and had blurred vision earlier ... Read more
Called in to assess patient. Per daughter, " she was feeling jittery and had blurred vision earlier but she said she's feeling better now ". Patient denied dizziness/ headaches/ shortness of breath. BP noted to be elevated at 230/93, HR = 100, SaO2 = 98%. Rechecked after a few minutes still elevated. BP = 223/105, HR = 93. Seen by nurse practitioner on duty with instructions to take patient to urgent care if BP is still above 180 systolic. Patient taken to the urgent care reception accompanied by daughter. Warm hand off to RN on duty. Last V/S prior to transfer - BP = 230/80, HR = 81. No distress or discomfort.
82 2021-04-14 pain in extremity In the middle of the night, I AWAKENED to the MOST SEVERE PAIN in my left arm. Thought perhaps a clo... Read more
In the middle of the night, I AWAKENED to the MOST SEVERE PAIN in my left arm. Thought perhaps a clot or a heart attack. ALTHO IVE NEVER HAD EITHER SO I DIDNT KNOW WHAT WHAT HAPPENING. I just lay there in place. I was awake and alert so I figured neither of the above. However, when I tried to use my arm, in a number of directions, It was extremely painful. I could not put this arm behind my back as tho to scratch my back. I am not sure if it was an attack on a MUSCLE or TENDON. I do know that in December 2019 I was given a 3-day dose of CIPRO anti-Biotics WHEN in the middle of the THIRD night I awakened with exactly the same reaction to the COvid vaccine BUT IN MY RIGHT LEG. In both instances it has taken me months to heal. I did go for therapy for my right leg event. Not for the left arm. I can only conclude that there is a connection between the medications.
82 2021-04-15 weakness Received two steroid shots and curious if steroid shots weaken the COVID-19 Vaccine; Bronchitis; wea... Read more
Received two steroid shots and curious if steroid shots weaken the COVID-19 Vaccine; Bronchitis; weak; Had a bad temperature on Thursday; did not feel good; tickling in her throat with a dry little cough; tickling in her throat with a dry little cough; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9262, expiration date: May2021), via an unspecified route of administration on left arm on 01Feb2021 at SINGLE DOSE for COVID-19 immunization. The patient medical history included Minimal COPD and Had bronchitis all winter of last year. The patient did not receive any other products. The patient received two steroid shots in physician's office for bronchitis on left hip on 08Feb2021. The patient received flu shot in the Fall; not within 4 weeks prior to the COVID vaccine. Historical vaccines included first dose of BNT162B2; Solution for injection; Lot number: EL3246, expiration date: Apr2021), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization and had no problem with first COVID-19 Vaccine. The patient had no problem with first COVID-19 Vaccine. On an unspecified date after the second vaccine, the patient felt fine after she got the second COVID-19 Vaccine. Tuesday night, she started having tickling in her throat with a dry little cough. Wednesday, Thursday and Friday, she did not feel good. Had a bad temperature on Thursday (for one day). The patient thought that she was told not to get shots for 14 days after first vaccine. The patient felt curious if steroid shots weaken the COVID-19 Vaccine. The Treatment included the patient took Tylenol for the body temperature. The outcome of the events body temperature was recovered, and bronchitis was not recovered while other events was unknown.
82 2021-04-16 feeling cold This all happened after the second shot I felt nothing except a sore arm after the first shot. I im... Read more
This all happened after the second shot I felt nothing except a sore arm after the first shot. I immediately felt dizzy and nauseous. Nausea continued for days--intermittently for 3 weeks. Severe headache, muscle and joint pains, fatigue. Very very cold the fist night. slight fever. In the morning my nightgown was soaking wet. Headache persisted for a few days. Eventually loss of tast but that returned. The only thing that persists is intermittent fatigue and nausea.
82 2021-04-17 bell's palsy, numbness Patient received her Pfizer Covid-19 shot on Wednesday April 14th at 5:30 pm. She stayed at the pha... Read more
Patient received her Pfizer Covid-19 shot on Wednesday April 14th at 5:30 pm. She stayed at the pharmacy area for 15 minutes with no symptoms and went home. Three days later on Saturday April 17th, she woke up and not being able to feel her right side of her face. She went to Emergency room and doctor told her that she has bell's palsy due to covid-19 shot. She was prescribed Prednisone 20mg and Valtrex 1g.
82 2021-04-19 unresponsive to stimuli Patients husband was bringing his daughter to a vaccine event. Spouse spoke of concern over his wif... Read more
Patients husband was bringing his daughter to a vaccine event. Spouse spoke of concern over his wife having a Pfizer COVID-19 vaccine in January and withing 24 hours being found unresponsive. Patient details that she did not show symptoms of distress after this second vaccination. He went to check on her in the morning on 1/28/21 at different points in the morning but when checking on patient at around 11:00 AM she was found laying on her side unresponsive, not breathing. Emergency medical profesisonals arrived but resuscitation efforts were unsuccessful.
82 2021-04-22 speech disorder, cold sweat Pt sitting for her 15 minute post vaccine period. At end of 15 minutes she was noted to become less ... Read more
Pt sitting for her 15 minute post vaccine period. At end of 15 minutes she was noted to become less responsive and slump in her chair. Speech not clear, could not keep eyes open. Appeared pale and clammy. Lightly retching but did not vomit. With 2 assist were able to get patient to wheechair and then to gurney nearby. BP immediately taken - it was ~ 165/80. Pulse = 70. Pulse ox = 94%. Her color remained somewhat pale. Pt able to talk more clear and state she is a diabetic and requests glucose check. We called a "first responder". Glucose machine arrived and her glucose was noted to be 287. She notes it has been "very up and down lately" and recently made changes in her insulin/med regimen. She states she did eat breakfast and took both her long and short acting insulin. She did eat a cracker and then after ~ 20 minutes wanted to sit up. She sat up and appeared improved but not 100%. Her BP sitting up was ~ 125/70. Pulse remained 70. She then stood up to get into wheelchair but once in wheelchair began to become less responsive again and appeared more pale. She was then put back on gurney with assist of 3 and taken to ER. Per ER note, she did have some vomiting and dizziness. Her BP was initially 222/99. BP improved to 1178/84. She was given meclizine and rested. She felt improved and able to ambulate, and was dc'd from ER.
82 2021-04-24 feeling hot could not open her mouth almost like lockjaw; could not chew; face was hot and puffy; face was hot a... Read more
could not open her mouth almost like lockjaw; could not chew; face was hot and puffy; face was hot and puffy; might have some fever; This is a spontaneous report from a contactable consumer (Patient himself). An 82-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown, ExpirationDate: Unknown) on 30Mar2021 via unspecified route of administration at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient stated the next morning she could not open her mouth, could not chew, face was hot and puffy, might have some fever also. She took a couple of Aleve, and it went away after couple of days. The patient stated she didn't know for sure if it was related to the Covid-19 vaccine or not. The day that she got the Covid-19 vaccine, later provided as 30Mar2021, she felt fine and never had a sore arm or fever. It was reported that it was almost like lockjaw, that she couldn't brush her teeth or chew. The patient reported that later in the day, the side of her face was all hot and might have been swollen and she took ibuprofen and that the inability to open her mouth went away in a couple of days. The reporter assessed the events as non-serious. The patient reported that she went to the chiropractor a couple of days later and the chiropractor said that he had heard about patients experiencing lockjaw after receiving the Covid-19 vaccine and she looked on Pfizer's website and the AE she experienced was not listed as a side effect. She is just a little concerned as she is scheduled to receive her second dose of the Covid-19 vaccine next week on 20Apr2021. She is afraid that the lockjaw might come back and might be worse. She is just curious if she is the only one that experienced the inability to open her mouth. The patient reported she does not know anyone that had this reaction and it is not listed as a side effect on Pfizer's website. The outcome of the event was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
82 2021-04-24 pain in extremity I had a lot of reaction from the COVID shot. I had a bad bad flare with my arthritis by being off of... Read more
I had a lot of reaction from the COVID shot. I had a bad bad flare with my arthritis by being off of the Xeljanz; I have been extremely fatigued; I had a few headaches which is extremely rare for me to have a headache; Can't use left hand/Painful to sit down and straighten the leg up; Right leg and knee and joints are so swollen; A lot of pain; Hard to get up from a chair or get in and out of bed; This is a spontaneous report from Pfizer Sponsored Program. A contactable 82 year old female consumer (patient) reported for herself, took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number EN6206, Expiration date were unknown), via unspecified route anatomical site of injection administration stated by the patient was Left upper arm on 18Mar2021 for COVID-19 immunization and had a co suspect as Tofacitinib Citrate( XELJANZ) as prescribed 5 mg tablets which was stopped by the patient to take BNT162B2. The patient's medical history reported was rheumatoid arthritis, Chronic kidney disease, AFibrillation and unspecified allergy. The concomitant medications included were Paracetamol(TYLENOL) was taken for pain whenever she needed. Apixaban(ELIQUIS) as 5mg twice daily, Bumetanide(BUMETANIDE) as ongoing, VITAMIN D3 as 1000 units daily, Ubidecarenone (COQ-10) 30mg once daily, Metoprolol(METOPROLOL)50mg twice daily, Prednisone(PREDNISONE) 5mg once a day, Cyanocobalamin(VITAMIN B12 CYANOCOBALAMIN) ongoing, Digoxin(DIGOXIN) 0.125mg once daily tablet ongoing. She had to take anit-histamines at this time of the year. They said she should not take Covid 19 BNT162B2 and Tofacitinib Citrate( XELJANZ) at the same time. She had been off it for two weeks and she had a lot of reaction from the COVID shot. She had a bad flare with her arthritis by being off of the XELJANZ but she was back on it for a little while. She had to delay her second dose of the vaccine because of it and that she would have to go off of it for another two weeks when she get the second dose for 8Apr2021. She was not sure if she should try as her right leg was in bad pain. stated that she had been off XELJANZ to take the COVID 19 shot. Patient was afraid to take that second shot. She had been extremely fatigued and had a few headaches which was extremely rare for her to have a headache. They did not last very long, they were more of like just pain in her head and uncomfortable for a few minutes and it went away. Her main concern was that her hands were so swollen, that it was very difficult to take care of herself. And her legs as well as it was hard to get up from a chair or get in and out of bed as it was painful. She did not know what to do as to go off of the XELJANZ for two weeks, which unfortunately both are Pfizer medications. She could not use her left hand and her right leg, knee and joints were so swollen. It was painful to sit down and straighten the leg up and she was in a lot of pain. She was supposed to stay off of this XELJANZ right after taking the first shot which she did, did not take XELJANZ until 3Apr2021 which was a full two weeks period, that was her Rheumatoid Arthritis. Outcome of the events was unknown. Additional information has been requested.
82 2021-04-25 mild one side paralysis, speech disorder, slurring Pt received Dose #1 of COVID-Pfizer vaccine on 3/15/21 and Dose #2 on 4/1/21 (location pt received i... Read more
Pt received Dose #1 of COVID-Pfizer vaccine on 3/15/21 and Dose #2 on 4/1/21 (location pt received is unknown by this reporter); pt was presented to ED on 4/25/21 @ 1427 with confusion, dysarthria, R-sided weakness. Head CT showed L sagittal sinus thrombosis and pt was started on a heparin drip per protocol. On 4/26/21 pt still noted to have RUE weakness, however speech had improved. Pt is still hospitalized in the ICU as of this report on 4/26/21.
82 2021-04-26 weakness chills; fever; achy joints; headache; metallic taste; loss of appetite/lost appetite/no appetite; ve... Read more
chills; fever; achy joints; headache; metallic taste; loss of appetite/lost appetite/no appetite; very weak; tired; uncontrollable teeth chattering; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 9266), via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 82-years-old) at a single dose for covid-19 immunisation. Medical history included Hashimoto disease and known allergies: penicillin. Concomitant medications patient received in two weeks included nebivolol hydrochloride (BYSTOLIC); rosuvastatin calcium (CRESTOR); levothyroxine. The patient previously took first dose of BNT162B2 (Lot number: EN-5318) on 25Jan2021 at 02:15 PM in the left arm at a single dose for covid-19 immunisation. On 20Jan2021 at 09:00 PM, the patient experienced chills, fever, achy joints, headache, metallic taste, loss of appetite which lasted for 2 days. On the 5th day after vaccine, I lost appetite again felt very weak and tired all day and by evening I spiked a fever 102.2 with uncontrollable teeth chattering. The same occurred 6th day, metal taste, no appetite, fever 101.2. Today is 7th day, still no appetite and temp are normal. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.2 on 20Feb2021, 101.2 on 21Feb2021 and normal on 22Feb2021. The patient was recovering from all the events.
82 2021-04-29 pain in extremity reports having body aches intermittently since February and is unsure what they were related to. Sta... Read more
reports having body aches intermittently since February and is unsure what they were related to. States she discussed with someone in the community who had similar symptoms and they gave her our phone number. She reports "excruciating" arm and thigh pain that started approximately two weeks ago. She has seen her primary care doctor on several occasions and RX prednisone orally for her body aches. She has had blood work for evaluation that is normal per her report. She is pending a follow up with her oncologist in May for breast cancer. advised that she contact her oncologist for possible PET scan and or earlier follow up. I explained this is unlikely related to vaccine given the length of time between exposure and symptoms. I explained that I will follow up with her in a week to see how things are going to be sure. She was happy with this plan.
82 2021-04-30 pain in extremity stomach pains; diarrhea; Sore Arm; This is a spontaneous report from a contactable consumer (patient... Read more
stomach pains; diarrhea; Sore Arm; This is a spontaneous report from a contactable consumer (patient). An 82-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of the Pfizer Covid Vaccine (BNT162B2) on 16Mar2021 (lot number: EP7534) at 82-years-old for COVID-19 immunization and had sore arm from first vaccine. The patient experienced sore arm from second vaccine on 06Apr2021 and stomach pains and diarrhea on 08Apr2021 at 17:00. The reporter stated she had the second dose of the vaccine on Tuesday (06Apr2021). On Thursday (08Apr2021) she got severe stomach pains and had diarrhea for an hour and half straight. Later that morning it happened, and at 3:30, 4:30 and between 6:00 and 7:00. It happened 6 times and just poured out of her. She had been ok since that. It was really bad. She asked if this is a side effect of the vaccine. The events didn't require a visit to Emergency Room or Physician Office. The patient called physician this morning. Treatment of the event sore arm included Arm Tylenol. The outcome of the event sore arm was recovered on 08Apr2021. The outcome of the other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
82 2021-04-30 pain in extremity could hardly walk; arm was very sore; stomach was upset; Slight Headache; Diarrhea; Slight fever; Mu... Read more
could hardly walk; arm was very sore; stomach was upset; Slight Headache; Diarrhea; Slight fever; Muscle ache; felt bad; Sore throat; bled after her injection; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8727), via an unspecified route of administration in the left arm on 25Mar2021 between 15:30-16:00 (at the age of 82-years-old) as a single dose for COVID-19 immunization; apixaban (ELIQUIS) via an unspecified route of administration at 5 mg twice a day from an unspecified date in 2018 and ongoing as a blood thinner/for the heart. Medical history included diabetes (started a couple of years before 2018), arthritis, lupus since 2020 (started just 6 months ago), high cholesterol, heart disease, all ongoing; as well as aortic valve replacement and pacemaker in 2016; she had all 3 types of arthritis: osteo, rheumatoid, and the one with the rashes, she has had aches and pains for a long time; arthritis pain; heart surgery in 2016; COVID-19 in the last part of Jul2020 to the first 2-3 weeks in Aug2020 (and then tested negative on 19Aug2020) with the following symptoms: bad headache, muscle aches, diarrhea, loss of smell and taste, "just about everything" for almost 4 weeks, autoimmune disease, diuretic and muscle relaxant therapy. Ongoing concomitant medications included glimepiride for diabetes from 2014, potassium tablet as a diuretic from 2016, furosemide as a diuretic from 2016, metoprolol for the heart from 2016, atorvastatin for cholesterol, hydrocodone for pain, tizanidine as a muscle relaxant, cinnamomum verum (CINNAMON) capsule, ascorbic acid (VITAMIN C), fish oil, ubidecarenone (COQ-10), vitamin D3, paracetamol (TYLENOL ARTHRITIS PAIN) tablet for arthritis pain, and an unspecified multivitamin. There were no additional vaccines administered on the same date or 4 weeks prior to BNT162B2. On25Mar2021, the patient bled after her injection, the blood started running down her arm when they pulled the needle out. The patient experienced sore throat on 25Mar2021 at 22:00, which was not excruciating, and the patient did not take anything for it. After waking the next morning, the sore throat was gone. The patient took paracetamol daily in the morning, and she wasn't sure if that was why her sore throat went away or not. She stated that when she had COVID disease the paracetamol didn't help her sore throat or headache at that time. The patient then started to have muscle ache on 26Mar2021 and a slight fever, never over 98 degrees, and she felt bad. The patient's normal temperature was around 97 degrees. The patient experienced a slight headache on 27Mar2021, diarrhea for 1 day and stomach upset on 27Mar2021 and then diarrhea again on 31Mar2021 for 1 day. The patient didn't take anything for the diarrhea, it was not that severe. The muscle aches continued in the upper part of legs, thighs, upper arms to her elbows. The patient had never had a hurting like that in her muscles and on an unspecified date, the patient could hardly walk since it was hurting so bad. On an unspecified date, the patient's arm was very sore. The events did not require an emergency room or physician office visit. The patient did call her doctor because she was hurting so bad who informed her that he had heard of other people who had the disease were having a reaction to the first vaccine. The action taken in response to the events for apixaban was dose not changed. The clinical outcome of sore throat was resolved on 26Mar2021 (duration 1 day), muscle ache was resolved on 03Apr2021 (duration 8 days), slight headache was resolved on 04Apr2021 (duration 8 days), diarrhea occurring on 27Mar2021 was resolved on 28Mar2021 and diarrhea occurring on 31Mar2021 was resolved on 01Apr2021, slight fever was resolved on 26Mar2021 (duration 1 day), stomach was upset was resolved on an unspecified date, and of could hardly walk, arm was very sore, bled after her injection, felt bad was unknown. No follow-up attempts are possible. No further information is expected.
82 2021-05-02 weakness, pain in extremity, cold extremities Approximately 40 hours after second Pfizer vaccine, patient complained of pain in lower right leg, a... Read more
Approximately 40 hours after second Pfizer vaccine, patient complained of pain in lower right leg, and a cold foot, lethargy, weakness, feeling unwell. 3 days later, shortness of breath, difficulty breathing, rapid heartbeat, and confusion began. Went to Medical center on 4/20/21, diagnosed with DVT, PE and clots in and around the heart and passed away on 4/21/21 of cardiac shock in the setting of pulmonary and arterial thrombosis.
82 2021-05-03 pain in extremity right leg: sore, pinkish, swelling, puffiness, sore walking and climbing steps dr. visit, on March, ... Read more
right leg: sore, pinkish, swelling, puffiness, sore walking and climbing steps dr. visit, on March, sent to ER for ultrasound, admitted to ER for visit and tests Deep Vein Thrombosis in right leg and superficial blood clots in right leg diagnosed eliquis prescribed for 3 months
82 2021-05-05 slurring Raging High Blood Pressures - Hospitalized and placed on Heart & blood Pressures 2nd Hospitalization... Read more
Raging High Blood Pressures - Hospitalized and placed on Heart & blood Pressures 2nd Hospitalization 3/3/21 High Blood Pressure and Mini Stroke It has been 2 months and still have fluctating blood pressures
82 2021-05-06 pain in extremity Arm soreness, itchiness directly following injection and continuing to a lesser degree to this day, ... Read more
Arm soreness, itchiness directly following injection and continuing to a lesser degree to this day, nearly 3 months later.
82 2021-05-07 weakness, pain in extremity Headache; stomach cramps; pain in legs and weakness; pain in legs and weakness; not hungry; arm pain... Read more
Headache; stomach cramps; pain in legs and weakness; pain in legs and weakness; not hungry; arm pain; This is a spontaneous report from a contactable consumer. An 82-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 05Feb2021 at 12:30 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included hypertension. Concomitant medication included lisinopril. On 05Feb2021 at 21:00 patient started experiencing headache, stomach cramps, pain in legs and weakness, not hungry, arm pain. The patient did not received treatment for the events. At the time of the reporting the patient had not yet recovered from the events. Follow-up attempts are completed. No further information is expected.
82 2021-05-10 weakness, tremor, pain in extremity, feeling hot, cold sweat Two days after vaccine I started with pain in my jaw joint down my neck into both arms that lasted 2... Read more
Two days after vaccine I started with pain in my jaw joint down my neck into both arms that lasted 2 minutes, then it came back in a couple hours and now it's still coming and going. It's more in my right arm and I cannot lift my arm when it's happening and it leaves me weak, trembling and in a cold sweat and sometimes I'm real hot. In February I went to the hospital and 4 doctors looked at me, I stayed there one day overnight . I kind of think that I was given the whole vial of the vaccine and want to know how long will it take for it to wear off, I watched them draw up the vaccine and they gave me everything in the vial. I think I got the whole vial.
82 2021-05-10 cold sweat, feeling cold Lightheaded and feels like she may faint; Cold Sweats, then Freezing; Cold Sweats, then Freezing; Di... Read more
Lightheaded and feels like she may faint; Cold Sweats, then Freezing; Cold Sweats, then Freezing; Diarrhea; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient) reported that an 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration administered in right arm on 09Apr2021 (Lot Number: EW0150) as single dose for COVID-19 immunisation. Medical history included ongoing Parkinson's disease started 5 years ago or more. The patient's concomitant medications were not reported. The patient took the first dose of BNT162B2 (lot# EL9267) on 12Mar2021 and second dose 09Apr2021, which was technically more than 21 days, it was 4 weeks. The patient was very sick and experiencing diarrhea on 12Apr2021, diarrhea was better last night on 14Apr2021 and she was feeling pretty good when she went to bed and then it is back with a vengeance this morning. The patient took 2 Imodium and then she had another episode of diarrhea so she took another one. The patient experienced lightheaded and felt like she may faint, cold sweats, then freezing on 15Apr2021. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
82 2021-05-10 pain in extremity Patient started to experience left arm pain hours after the vaccination on 05/04/2021, and the pain ... Read more
Patient started to experience left arm pain hours after the vaccination on 05/04/2021, and the pain gradually moved to the patient's left chest wall, anterior chest and right chest wall, patient was having shallow breathing limited by pleuritic pain, presented to the ED on 5/10/2021 and was diagnosed with acute bilateral nonobstructive pulmonary emboli based on CT angiogram chest.
82 2021-05-10 speech disorder Patient admitted on 5/5/21 for suspected acute ischemic CVA after presenting with altered speech for... Read more
Patient admitted on 5/5/21 for suspected acute ischemic CVA after presenting with altered speech for a day (last known well on 5/4/21 PM). No CT evidence of an acute intracranial process. Her pacemaker precluded MRI evaluation. Pacer interrogated on 5/6/21 with AT/AF burden <0.1%. She was seen in consultation by neurology. Evaluation and clinical deficits were suggestive of acute ischemic CVA. Risk factors for CVA include age, HTN, Afib. Patient recently received her first COVID-19 vaccine (Pfizer) on 4/26/21. Patient?s symptoms improving with antiplatelet and statin therapies along with blood pressure management. Per Neurology consult, possible etiologies include cardioembolic versus atheroembolic versus thrombotic versus inflammatory related to recent COVID-19 vaccine. The neurologist specifically stated that ?The COVID vaccine was temporally close to this event. I have seen transient CNS inflammation from the vaccine--probability low but still possibility.?
82 2021-05-11 weakness Was very weak, dizzy, poor memory. I felt very extreme health reaction for over 7 days. It was my ... Read more
Was very weak, dizzy, poor memory. I felt very extreme health reaction for over 7 days. It was my error not acknowledging allergic to Sulfa.
82 2021-05-13 seizure J18.9 - Pneumonia, unspecified organism D69.6 - Thrombocytopenia, unspecified R56.9 - Unspecified co... Read more
J18.9 - Pneumonia, unspecified organism D69.6 - Thrombocytopenia, unspecified R56.9 - Unspecified convulsions
82 2021-05-17 seizure, unresponsive to stimuli, pain in extremity She received her first dose on 2/6/21 around 11:30 a.m. On 2/7/21 she was a bit tired and her arm ... Read more
She received her first dose on 2/6/21 around 11:30 a.m. On 2/7/21 she was a bit tired and her arm was a little sore. Sometime after the afternoon of 2/7/21 and the morning of 2/8/21 she was found unconscious and unresponsive on the floor. As her dinner from the evening of 2/7/21 was still on the table unfinished and she was fully dressed we assume that whatever caused her to end up on the floor unconscious happened on 2/7/21 She was taken to the emergency room and it was determined that she was not going to survive. She never regained consciousness and was having seizures all the way to the hospital in the back of the ambulance. She was made comfortable and passed on 2/11/21.
82 2021-05-18 muscle spasms OVERALL ACHING; Leg cramps for 3 weeks.; This is a spontaneous report from a contactable Non health... Read more
OVERALL ACHING; Leg cramps for 3 weeks.; This is a spontaneous report from a contactable Non health care professional, the patient. An 82-year-old non pregnant female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA vaccine, Lot/Batch no: Illegible, Dose number:2) via unspecified route of administration in the left arm on 23FEB2021 at 14 hrs 15 min as the second dose for Covid-19 immunization. Patient had taken BNT162B2(PFIZER-BIONTECH COVID-19 mRNA vaccine, Lot/Batch no: EL3247, Dose number:1) on the left arm on 02Feb2021 at 14 hrs 15 min as the first dose for covid -19 immunization. Medical history included CABG 2011, hiatal hernia, low iron and allergy to artificial sweeteners. Concomitant medication(s) included Iron and Calcium within 2 weeks of vaccination. The patient previously took Levaquin and experienced allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and neither tested positive since the vaccination. The patient experienced Leg cramps and overall aching on 24Feb2021 and continued for 3 weeks. The patient aching was so bad and she went to primary care office. Therapeutic measures were taken as a result of leg cramps and overall aching and included treatment with Celebrex for 2 weeks with no relief in pain. The patient has still not recovered from leg cramps and overall aching. Information about lot/batch number cannot be obtained. No further information is expected.
82 2021-05-26 pain in extremity Pain in her jaws down to her arm and she cannot even lift it.; Pain in her jaws down to her arm and ... Read more
Pain in her jaws down to her arm and she cannot even lift it.; Pain in her jaws down to her arm and she cannot even lift it.; Pain in her jaws down to her arm and she cannot even lift it.; This is a spontaneous report received from a contactable consumer (patient). A 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EL9269) at the age of 82-years-old as single dose for covid-19 immunization. Medical history included heart attack when she was 25 years old. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unknown date for covid-19 immunization. Patient had called about a reaction to the second vaccine on 18Feb2021 and she was still having side effects. Wanted to know if this was a time released drug and how long can she expect the side effects to last. Stated that she has pain in her jaws down to her arm and she cannot even lift it. Stated that it was really bad in her right arm. Wanted to know when she got a pain really bad was there anything that she can do to lessen it and when can she expect it to end. Was wondering if she was given more than the recommended dose. Wanted to know how many doses were in a vial. Wanted to know what would be the side effects if she were given more than the recommended dose or when it will end. Stated that she was in the hospital overnight and they did tests. Was told that she was having a reaction to the vaccine that they thought would not last long but has continued to last. Stated that the hospital did a temporary report. Stated that she had a report completed with Pfizer today. The outcome of the events was not recovered.
82 2021-05-28 pain in extremity arm was real sore; couldn't almost lift it; This is a spontaneous report from a contactable consumer... Read more
arm was real sore; couldn't almost lift it; This is a spontaneous report from a contactable consumer (patient). A 82-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9261, Expiration date: 31May2021), via an intramuscular route on 22Jan2021 at 13:00 (at the age of 82-years-old) as 1st dose, single in the deltoid right for covid-19 immunisation. The patient medical history included trigeminal neuralgia diagnosed with this condition at least a good 10 years ago. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included TOPAMAX tablet with dose 150 mg, daily, (one 50 mg, tablet, by mouth, once in the morning; two tablets at night /Total of 150 mg daily) for trigeminal neuralgia. Caller received the COVID vaccine on 22Jan2021 and five days later on 27Jan2021 at 20:00, the patient arm was real sore and she couldn't almost lift her arm which she thought was an unusual reaction. She doesn't believed she did anything to her arm. She doesn't know if she pulled a muscle or anything. By the next morning, 28Jan2021, the soreness was gone and was fine. She hasn't had any problem since. The outcome of the events was recovered on 28Jan2021. Follow-up attempts are completed. No further information is expected.
82 2021-05-31 breast pain, pain in extremity Shortness of breath.; pain in left shoulder/arm/breast; pain in left shoulder/arm/breast; pain in le... Read more
Shortness of breath.; pain in left shoulder/arm/breast; pain in left shoulder/arm/breast; pain in left shoulder/arm/breast; This is a spontaneous report from a contactable consumer (patient). This 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 14:30 (Lot Number: EN6200) as single dose (at 82 years old) for COVID-19 immunisation. Medical history included complex regional pain syndrome, scoliosis, primary biliary cholangitis, hypersensitivity. On 26Feb2021 00:30, the patient experienced shortness of breath, pain in left shoulder/arm/breast with outcome of not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
82 2021-05-31 pain in extremity my right foot started to bother me on the ball of my foot. It is swollen and hurts to walk on.; my r... Read more
my right foot started to bother me on the ball of my foot. It is swollen and hurts to walk on.; my right foot started to bother me on the ball of my foot. It is swollen and hurts to walk on.; pain down the left side then nothing else but a little in the arm; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 82-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL9262; Expiration Date: 31May2021), via an unspecified route of administration, administered in top of left arm on 26Jan2021 (at the age of 82-years) as 0.3 mL, SINGLE DOSE for covid-19 immunization. Medical history included: sinus disorder, gastrooesophageal reflux disease, cholesterol. She has had cholesterol for years. She has sinus problems on and off. She suffers from GERD. She was on a pill to help with the stomach prior, but not on it now. She took the last one on 30Jan2021. She had been on it for two months. She doesn't remember the name of the medication. It was a time released capsule. The patient did not receive any prior vaccinations within 4 weeks. Concomitant medications included: ongoing simvastatin (20 mg at night) taken for blood cholesterol and unspecified vitamins. She has been on simvastatin (generic for Zocor) for about eight years. She was on Lipitor (strength: unknown) for years and changed to Simvastatin. She got off Lipitor because she felt like it wasn't doing what it was supposed to do. Caller doesn't have product to provide lot number. She hasn't been on it for 10 to 12 years. No vaccines administered on same date of the Pfizer suspect. On an unspecified date in Jan2021, the patient had pain down the left side then nothing else but a little in the arm. On 30Jan2021, the patient's right foot started to bother on the ball of her foot. It was swollen and hurts to walk on. The clinical course included: the patient got her COVID shot on Tuesday (26Jan2021). She did in the middle of the night have pain down the left side then nothing else but a little in the arm. Then on Saturday (30Jan2021), her right foot started bothering her on the ball of her foot. It was a burning sensation. Yesterday was very bad and she could hardly walk. It is swollen on the bottom of the ball of her foot and across the top where her toes are. Her son just kept calling and telling her to check her temperature and pulse rate. She took Tylenol (strength: 500mg, Lot number: HDAO52; she had only taken two of them and it expired on Feb2019. She took one yesterday afternoon and one last night when she went to bed), applied ice (off and on), and elevated it and the swelling didn't go down. She did elevate it above her heart. Again, this morning she has the same thing. She was having a heck of a time walking. It was very painful. She was hoping she can walk normal again. It was still painful today. If she accidentally bumps it, it hurts. It was swollen. It started 4 days after receiving the vaccine. Caller stated she no longer had the problem with her arm. She has recovered completely. It was only bothering her a little bit on the twenty seventh (27Jan2021), but nothing to be concerned about. Investigations included: She hasn't been able to taste for some time and had a COVID test in December and she was negative. She was still having trouble tasting and had a CT scan of her sinuses last week (results not reported). She will follow up with her doctor about that. The outcome of event pain down the left side then nothing else but a little in the arm was resolved on an unspecified date in 2021 and for other events it was unknown. Follow-up attempts are completed. No further information is expected.
82 2021-06-02 feeling hot Quiet. Not think correctly. Low Fever. Warm hands
82 2021-06-02 muscle spasms Chills, Fever, sore throat, running nose, constipation, Diarrhea, shortness of breath, muscle cramps... Read more
Chills, Fever, sore throat, running nose, constipation, Diarrhea, shortness of breath, muscle cramps in both legs, muscle aches in all parts of body. Each symptom was not severe except muscle cramps. Muscle aches and shortness of breath still happening.
82 2021-06-04 weakness, pain in extremity Lymphedema in her legs/ got lymphedema about 5-6 days after the second Pfizer vaccine; Legs were hur... Read more
Lymphedema in her legs/ got lymphedema about 5-6 days after the second Pfizer vaccine; Legs were hurting like the devil; Legs were about six times the size they should be/ she has intense swelling; Peeing too much; Doesn't feel right; she is just so weak; This is a spontaneous report received from a contactable consumer (patient). An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261; Expiration Date: 31May202, NDC: 59267-1000-2), via an unspecified route of administration, administered on left arm on 06Feb2021 at 12:00 as 2nd dose, single for COVID-19 immunisation. Medical history included ongoing emphysema, ongoing breast cancer from 2007 (she did not take chemo, just radiation) and ongoing follicular lymphoma from 2014 (did not take chemo, just radiation. Cancer was in the bone marrow, said she didn't think that has anything to do with it, has had two operations) and bone marrow cancer. The patient previously took budesonide/ formoterol fumarate (SYMBICORT) she was using SYMBICORT, but her doctor switched it a few months ago, back to ANORO), prochlorperazine maleate (COMPAZINE) she takes a couple of times per month, takes 10mg when she feels nauseated and pseudoephedrine hydrochloride (SUDAFED) she takes when she needs it. Concomitant medications included furosemide (LASIX) at 40 mg, twice a day (one 40mg pill in the morning and one 40mg pill at night) from 1985 to an unspecified date and then increased to 80 mg, twice a day (two pills (80mg total) in the morning and two (80 mg total) at night) from on an unspecified date and ongoing for blood pressure; ongoing simvastatin (ZOCOR) taken for high triglycerides; umeclidinium bromide/ vilanterol trifenatate (ANORO). Patient thought she has been on Lasix since 1985 but can't remember back that far. She was taking Zocor for a long time and stated Anoro Inhaler was a fairly new medication. For Anoro inhaler, patient stated she pulls back the thing and didn't know, maybe it pinches a pill and inhales the white powder. Relevant family medical history included none and both parents were deceased. Patient stated that her oncologist does blood tests once every four months, a test for markers and stuff like that, CBC, metabolic panel and bloodwork every 4 months. The patient previously took first dose of BNT162B2 (Lot number: EL3246, Expiration date: 30Apr2021, NDC: 59267-1000-2) via unspecified route of administration in left arm on 14Jan2021 12:00 pm for COVID-19 immunisation. It was reported that, the patient has very sexy legs, but she doesn't anymore, says she got lymphedema about 5-6 days after the second Pfizer vaccine in Feb2021. She was now going to physical therapy, to bear her out and try to understand what she's saying. Caller states 30% of the people there that have had cancer and had radiation, get the same side effect she has had, some people have it in the arms, she got hers in her leg, says she has intense swelling, called lymphedema, says her legs look like they belong on an elephant. Caller said at the physical therapy place, 30% of people who have come in for help had radiation treatment for some kind of cancer, all have different kinds of cancer, but the swelling, the lymphedema, was the side effect they've all experienced. Caller states that no one has called Pfizer and let Pfizer know, states she won't take the booster, won't have anything to do with this, says it's too scary. Caller states she was an active person, never had a problem with legs swelling or anything like that and now, her look like legs that belong on an elephant. Caller states the correlation seems to be with radiation treatment, because she has bone marrow cancer, and other ladies have breast cancer, states the only thing we all have in common was different treatments but in her own case she had no chemo, but she did have radiation. It seems like with radiation this swelling was an after effect. Caller says it's 2 or 3 things, not just that they had cancer or radiation treatment, says those of us who had radiation also got this swelling. Caller states she never had any trouble with legs or anything, says she was an active person. States some people experienced this four days after the vaccine, says hers started six days after the vaccine, says she woke up one morning, and her legs were huge. States usually legs were smaller in the morning. Caller wonders what were the ingredients that causes swelling. Caller states she doesn't know how to explain it, says like overnight turned a switch on and now her legs were going to be big and fat and ugly. Caller states the reason she's calling was because at physical therapy last Thursday, other people who had the shot had the same side effect, says the only thing the lady said, she wasn't sure if she was a nurse or not, was the relationship was not with the kind of cancer, but the radiation treatment and the shot has been causing this and wasn't surprised. Caller says she was told that about 30% that they're handling now had the Pfizer vaccine. Caller thinks that's all they gave in the state NC, no other vaccine here, says it just seems to be with this. Caller states the lymphedema, hers was in her legs, others have it in their arms, she doesn't know why it's happening. Caller states about six days after the second shot, she can't remember exactly what day, about six to seven days, she woke up one morning, and her legs were hurting like the devil in Feb2021, stated her legs were about six times the size they should be in Feb2021. Caller states usually in the morning, the swelling goes down, but this woke her up out of the blue like zap, says no warning, no nothing, just one day she woke up and that where it was. Caller states her doctor increased Lasix, she used to take one 40mg pill in the morning and one 40mg pill at night, increased it to two pills (80mg total) in the morning and two (80 mg total) at night. Caller states she is now only taking one-and-a-half-pills this morning, because she doesn't feel right and she was peeing too much in Feb2021 and was not feeling right. She doesn't want to get dehydrated. Caller states she has a doctor appointment 10Jun2021 and was going to tell him she was taking less because she was just so weak in Feb2021. Says she was weak because she's taking too much Lasix, states she was taking two 40mg morning and night. Caller states she was just concerned, she has big legs, fat legs, she calls them fat. The patient not visited emergency room. The events result in the patient visited physician office. Patient reported that she has had no shots for four months however she was going to get the high dose flu shot on 01Oct2021. No relevant tests were performed at the time of this report. The outcome of the events lymphedema and Legs were about six times the size they should be was not recovered and outcome for the other events was unknown. No further details provided. Follow-up attempts are needed. Further information requested.
82 2021-06-06 weakness Patient is a 82 y.o. female with history of adenocardinoma left lower lobe lung s/p radiation, COPD,... Read more
Patient is a 82 y.o. female with history of adenocardinoma left lower lobe lung s/p radiation, COPD, nocturnal use of 3 liters oxygen, dementia, eliquis for hx dvt, esophageal stricture who presents today from clinic secondary to hypoxia. History obtained from daughter bedside and chart review as patient has dementia. Patient began feeling ill one week ago. Complains of cough, congestion, wheezing, shortness of breath, mild wheezing, chest discomfort with coughing, fatigue, and decreased energy. She has had one episode of loose stool. Denies fevers, chills, loss of taste/smell. She was evaluated by pulmonology on 5/25 and noted to have oxygen desaturation. She was recommended to go to the ED for further evaluation however patient refused and preferred home treatment. She was prescribed Augmentin for possible aspiration pneumonia as well as prednisone taper. Patient reportedly felt some mild improvement since starting treatment however continued to require use of 3 liters of oxygen during day and night rather than just at night. She followed up with clinic today where she continued to have oxygen desaturation despite supplemental oxygen and chest xray noted new infiltrate. She was again recommended to go to the ED for further evaluation and management at which time patient agreed.
82 2021-06-06 weakness Dizziness, headache, nausea, congestion, fever, weakness, shortness of breath,
82 2021-06-08 weakness The patient received two Pfizer-BioNTech vaccines; dates and lot information and administration site... Read more
The patient received two Pfizer-BioNTech vaccines; dates and lot information and administration site of vaccines are not available at the time of this report. The patient presented to Hospitial on 6/3/2021 complaining of weakness and left sided chest pain occuring over several days. She was tested for C19 via rapid test and found to be positive. She was isolated and treated for C19 symptoms. She has been discharged to a Nursing Home setting.
82 2021-06-09 feeling cold, pain in extremity bothers her is that her problem remembering words is getting worse./: Knees hurt was reported as wor... Read more
bothers her is that her problem remembering words is getting worse./: Knees hurt was reported as worsened.; it started from the top of her neck and her balance was off, she felt "fuzzy-headed"; She has been experiencing periods of tiredness where she does not want to do anything; increased forgetfulness in addition to her intermittent light headedness; increased forgetfulness in addition to her intermittent light headedness; Was cold; diarrhea; her knees hurt her; chills; mild fever; her arm was hurting; Arm was just a teensy bit sore at the injection site; Felt a little like balance was off; So tired I don't want to do anything; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6199, Expiration date: Jun2021), via an unspecified route on 13Mar2021 (age at the time 82-year-old) as 2nd dose, single dose in the left arm for covid-19 immunization. The patient medical history included osteoarthritis, fibromyalgia (reported that she was diagnosed with fibromyalgia close to 20 years ago, between 15-20 years ago). The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9269), via an unspecified route on 20Feb2021 at 10:00 (age at the time 82-year-old) as 1st dose, single dose in the left arm for covid-19 immunization. On 13Mar2021, the patient experienced armed was hurting, armed was just a teensy bit sore at the injection site, and the next day, on 14Mar2021 she had diarrhea and her knees hurt her and had chills and mild fever, was cold and felt a little liked balance was off. Patient reported that the next day, 15Mar2021, she was fine, on 16Mar2021 it started from the top of her neck and her balance was off, she felt fuzzy-headed, fuzzy headed feeling was now not so much, but she would have a day where she was so tired that she doesn't wanted to do anything. Patient experienced periods of tiredness where she did not want to do anything was reported as worsened and reporting increased forgetfulness in addition to her intermittent light headedness. Patient reported that she called the pharmacist who informed her that some reactions would go on for a few weeks. She reported that she was a senior, and most seniors had a problem where they couldn't remember a word then blinked and could've thought of it. She reported that the thing that bothers her was that her problem remembering words was getting worse and the problem remembering words had gotten worse from her baseline after she received the covid-19 vaccine, but it had stayed the same since originally worsening from baseline. Patient reported that the difficulty remembering words worsened around the same time that her fuzzy or lightheaded feeling began, and temperature was 99. 7. Patient explained that her armed did tended to hurt a little and that she received her shot in the affected armed and she was not sure if the diarrhea lasted the second day or not, but it resolved completely. she had a teeny problem with her knees and the covid-19 vaccine really nailed it. She reported that since she received the second dosed of the covid-19 vaccine, her knees had been terrible. She reported that what's really bothering her now was her knees. She reported that her knees were hurting so bad that she could've hardly walked. It was reported that patient visited to physician office. The outcome of the events diarrhea was resolved on Mar2021, armed was hurting was resolved on 14Mar2021, chills, mild fever, cold was resolved on 15Mar2021, felt a little liked balance was off was resolving, her knees hurt, so tired I did not want to be done anything was not recovered and other events was unknown. Information on lot/batch number was available. Additional information had been requested.
82 2021-06-09 pain in extremity At time of vaccination my arm hurt badly. 24 hours after the vaccine I had fever and chills. On the ... Read more
At time of vaccination my arm hurt badly. 24 hours after the vaccine I had fever and chills. On the 3rd day I woke up with sharp pain down my left arm, pain in my back and neck. On the 5th day I got lightheaded and dizzy. My blood pressure reached to 186/110 with a horrible headache. Went to the doctor and had a CT scan and stress test done. After 5 weeks my body is back to normal.
82 2021-06-10 weakness Weekness; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female ... Read more
Weekness; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration in the right arm on 02Mar2021 12:00 AM (at the age of 82-years-old) as second dose, single dose for COVID-19 immunisation at a hospital. Patient's medical history was not reported. Concomitant medications included antihistamines taken for an unspecified indication, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination. On 02Mar2021 12:00 AM, the patient experienced weekness. No treatment was taken for the events. The patient underwent lab test and procedure which included SARS-CoV-2 test (nasal swab, PCR test): negative on 03Mar2021. The outcome of the events was not recovered. No follow up attempts are possible; information about lot/batch number cannot be obtained.
82 2021-06-10 pain in extremity The morning after I received the vaccine, I started feeling tired and my arm was quite sore. The fol... Read more
The morning after I received the vaccine, I started feeling tired and my arm was quite sore. The following day, I had a fever of probably 100. I had chills and my heart rate and blood pressure went up. Since I have A-Fib, it was irregular. After several hours, my HR went back to normal and that is when I called my Cardiologist NP. She said that she thinks it's related to the fever I had. The next day, I felt a tad better, but fatigue and generally not feeling well lasted a few days. I feel that it took about a week before I felt normal again. About two months later, I was making plans to go out of town and I became very ill. I started having chills, fever, nausea and extreme fatigue. I may have taken some Tylenol. I was drinking a lot of water because I did not have an appetite. A couple days later I felt a little better so I did not contact my doctor, but I did go to an urgent care (05/22/2021) and had a COVID test. The test came back negative and I felt better two days later. On Monday, I started feeling bad again and I contacted my PCP, and I went to see him on Tuesday. He ran some blood tests and another COVID test, which came back negative. The fatigue just stayed around for quite some time. He monitored my sodium and chloride and they were both low so the doctor wanted them monitored. I was admitted into the hospital for two days. I was on liquid restriction. I had a bunch of tests ran that came back negative. I did have an AMA test which did come back positive. I am still on water restriction, but I am feeling much better. I'm a bit leery about receiving a booster shot.
82 2021-06-13 pain in extremity pain started in her left shoulder area and the general pain has traveled to her arm to her left thig... Read more
pain started in her left shoulder area and the general pain has traveled to her arm to her left thigh. Patient reports she went to to the doctor where an MRI was performed, she will get the results on 06/1/2021. She states she has been taking Tylenol 325mg.
82 2021-06-15 pain in extremity Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am... Read more
Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9262) via an unspecified route of administration, administered in left arm on 29Jan2021 at 12:00 (at the age of 82-year-old) as 1st single dose for COVID-19 immunisation. Patient medical history included high blood pressure (HI BP), osteoporosis, blood cholesterol increased, all from an unknown date and unknown if ongoing. Patient had no known allergies. The patient concomitant medications taken in two weeks of COVID-19 vaccination included pravastatin (PRAVASTATIN), hydralazine (HYDRALAZINE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), all taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that on Day 2, 30Jan2021 at 05:00, the patient had pain in left arm, could not lift coffee cup, lower back pain was off and on. Event gone on Day 4, but 'now' patient was nauseous and lightheaded and back pain was back but higher up. Patient received no treatment for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was reported as resolving and outcome of the event pain left arm was resolved on 01Feb2021. Follow-up attempts are completed. No further information is expected.
82 2021-06-23 burning sensation, feeling hot Nausea and vomiting; Nausea and vomiting; eyes started swelling and almost shut the left; Eyes and f... Read more
Nausea and vomiting; Nausea and vomiting; eyes started swelling and almost shut the left; Eyes and face swollen up; there was a big old sore like staph like someone had poured acid on her/ sores on scalp; she doesn't have any taste; rash forehead/ the side of her forehead was red, like fire red, but it was "kicking"/ rash on nose/ rash all over the place; She was very warm that day/ she started feeling hot; she started burning on left side of her head; pain on top of the forehead/ pain at top of head shooting left side of face; This is a spontaneous report from a contactable nurse (patient; retired nurse). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on the left arm on 29May2021 11:45 (at the age of 82-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included sensitive skin. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): None. No other vaccines administered on the same date of the Pfizer suspect. The patient had no other prior vaccinations within 4 weeks. Family medical history relevant to adverse events was reported as none. There were no relevant tests done. On 29May2021, the patient received the first dose of BNT162B2. She had the worse reaction and didn't know what to do as she hedn't read about it and now she was reading it and added that she was not taking another one. She should have gone to the emergency room, but she was afraid they would admit her. She had read this paper on what she should, and she had almost every time. She went to her physician on 25May2021, and that they were giving the vaccine at his office and that it would be on the Friday (28May2021). Her physician had said that she needed to take the virus shot, but Friday (28May2021), it would be like to 12 o'clock and she had been there on Tuesday for a physical. She said that they wanted her to make sure if she wasn't coming and reschedule. She said that she went to store on the following Saturday on 29May2021. After she got the shot, she sat there for 15 minutes and read a brochure and then stated that she had been there for 30 minutes. She was very warm that day and she went and did her little shopping and it was very hot. After she did all of the shopping that day (29May2021), she went somewhere else and when she did, she started feeling hot and it was hot outside and she thought she had better get out of the heat. She got home about 17:30. She got to feeling heat so bad and she sat on her porch which she always did before she goes in the house. She said later that day (29May2021), she started burning on left side of her head. Started burning like her head was on fire on left side of her forehead and it kept on. She had a sensitive skin, so she couldn't understand why it was burning so. She then stated that it was burning so bad she went to mirror to see what it was doing and added that the side of her forehead was red, like fire red, but it was "kicking". Her son told her to put some cold compresses on it. She stated that she had been putting warm and that it had helped. The patient had rash forehead and she had put warm compresses on it and laid down because it was feeling so bad and she went back and looked in mirror and it had turned into fire and rash all across left side of forehead. She said she thought she must be having reaction to this shot. The patient stated that she loved coffee but hadn't even drank her coffee because she doesn't have any taste on 29May2021. She then looked at the information that was provided and the next day (on 30May2021), there was a big old sore like staph like someone had poured acid on her and for 2 days, she didn't put anything on her head to touch it. The patient considered the events feeling hot as serious and persisting, rash on nose as serious, rash all over the place as disabling, but then commented it was medically significant, nausea and vomiting had improved but was serious, eyes and face swollen up and pain on top of the forehead as very serious (even with her sitting, she could feel the pain arising on the left side), and sores on scalp and head as serious as serious. The patient experienced heat at night and added that it felt like something was hitting her on the side of her head. She tried to get some ease and she got and tried to eat some soup. She then went to the bathroom and threw up (confirmed it was on 01Jun2021). The patient was still having pain on the left side, top of forehead and added that it was "shooting everything now and then". She then mentioned that it was coming back now. The patient then stated that it had been over a week and she was finally getting better. The patient stated that she wasn't going to the emergency room because they would want to admit her. She further stated that "you could to the emergency room with a thumbtack and be put on Intensive Care Unit" and reiterated that she wasn't going. The patient had rash in her hair and didn't want anything touching it as it was just painful and felt like a big old sore, like a scab. After two days on 31May2021, her eyes started swelling and almost shut the left. She applied Cortisone cream to rash on the 2nd day for one day only. Doesn't not have it available. No other treatment sought. The patient then stated that the rash, feeling hot, burning on left side of her head, rash on nose, pain at top of head shooting left side of face occurred later in the afternoon of 29May2021; while not provided for the other events. The events did not require a visit to the emergency room and/or physician office. The outcome of the events erythematous rash, nausea, and vomiting was recovering; for the events feeling hot, burning sensation, loss of taste, pain on top of the forehead/ pain at top of head shooting left side of face was not recovered; while for skin lesion, eyes swollen and swelling of face was unknown. The reporter considered the events to be related to the Pfizer COVID 19 vaccine. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE0 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
82 2021-06-23 night sweats Severe headaches, pain in body, night sweats, weakness in legs, tiredness, lumps throughout body, ri... Read more
Severe headaches, pain in body, night sweats, weakness in legs, tiredness, lumps throughout body, ringing in ears, unbalanced when walking
82 2021-06-24 weakness feels weak; fever; chills; headache; slight discomfort to injection site; This is a spontaneous repo... Read more
feels weak; fever; chills; headache; slight discomfort to injection site; This is a spontaneous report from a contactable consumer (patient herself) received from Pfizer-sponsored program. An 82-years-old female patient received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on 03Feb2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 04Feb2021 she experienced fever, chills, headache, slight discomfort to injection site, on 05Feb2021 she felt weak, caller received an appointment for her second dose on 03Mar2021 which is 4 weeks out rather than 3. The outcome of all events was unknown. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
82 2021-06-24 slurring Admitted to hospital testing positive for COVID after being fully vaccinated. Patient admitted 05/2... Read more
Admitted to hospital testing positive for COVID after being fully vaccinated. Patient admitted 05/29/21 with a GI bleed, patient asymptomatic for COVID s/s but was tested following hospital admission policies and had a positive PCR test on 05/29/2021. Patient reports her husband was positive for COVID a few weeks prior. Patient treated for GI bleed and d/c'd home on 05/30/2021. She returned to the hospital same day within a few hours reporting dizziness, syncopal episode, and slurred speech per medic. Admitted again with a-fib with RVR. No fever or cough, did report some shortness of breath at home. Discharged on 06/04/21, then readmitted for a-fib with RVR again, discharged home with homecare on 06/14/21.
82 2021-06-24 pain in extremity, muscle spasms Sleepy; She couldn't get up, she had a horrible and "very strong" pain in her leg, soon it started i... Read more
Sleepy; She couldn't get up, she had a horrible and "very strong" pain in her leg, soon it started in the other leg, like a "very strong cramp,"; She couldn't get up, she had a horrible and "very strong" pain in her leg, soon it started in the other leg, like a "very strong cramp,"; She felt the blood flow at a tremendous speed, from the waist down; It could be a circulation problem because of her varicose veins; It could be a circulation problem because of her varicose veins; she felt in her legs as if they had uncovered a sewer pipe and the water was squirting, she thinks she was probably dehydrated; This is a spontaneous report from Medical Information Team. A contactable consumer (patient) reported that a 82-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on 20Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. as per reported, She received the first dose on 20Apr2021, then went home and was very sleepy, she took a nap. When she woke up, she couldnt get up, she had a horrible and "very strong" pain in her leg, soon it started in the other leg, like a "very strong cramp," so she had to massage herself. She lived alone and when she got up, she felt the blood flow at a tremendous speed, from the waist down. After that she drank water and the feeling disappeared. She thought it could be a circulation problem because of her varicose veins, she takes aspirin. She thought her reaction the first time might have been vaccine-related, it was "horrifying, very strong," she felt in her legs as if they had uncovered a sewer pipe and the water was squirting, she thought she was probably dehydrated, so she was a little afraid to receive the second dose. However, now "I feel very good". Outcome of event Blood flow sensation was recovered on an unspecified date in 2021 and for remaining events its was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
82 2021-06-25 weakness The day after the second shot i had a low grade temperature of 99.3, Severe muscle aches, and very t... Read more
The day after the second shot i had a low grade temperature of 99.3, Severe muscle aches, and very tired. I began to have huge amounts of blood mucus, spitting it up and choking on it. Was given a sinus infection amoxicillin antibiotic and musilix and nasal sprays. 2 weeks The heavy blood mucus traveled into my eustachian tubes, imparing my hearing and making me off balance...3 weeks. Experienced sever headahce for a week and went to ER for Ct scan . No stroke or anyerism . Then the heavy bloody mucus went into my bronchi and lungs causing shortness of breath and weakness...given a pneumonia antiibiotic . I am currently on a prescription for Prednisone ( on the refill) and improving slightly but still weak and tired and shortness of breath. Still having shortness of breath (6/26/21_ and very tired. Cannot perform all my daily functions like taking a walk . I am able to prepare meals. adverse reaction still exits 2/25/21 - 6/26/21
82 2021-07-08 weakness Muscle pain on my arm; I had a bad day; Runny nose; Headache; Very tired and very weak; Very tired a... Read more
Muscle pain on my arm; I had a bad day; Runny nose; Headache; Very tired and very weak; Very tired and very weak; This is a spontaneous report from a contactable consumer. A 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 21Jan2021 (Batch/Lot Number: EL3247; Expiration Date: May2021) as dose number unknown, single (at the age of 82-years-old) for covid-19 immunisation. Medical history included that she had pacemaker and breast cancer. Concomitant medications included letrozole once a day and olmesartan medoxomil (BENICAR) 20mg, oral, once a day due to pacemaker and Letrozole. The patient stated that she was 83 years of old, second of all her doctor wants her to take it because she had breast cancer. The patient was very tired and very weak on 22Jan2021. The patient experienced few days of runny nose, headache and she bad day on 25Jan2021. The patient stated that last day she had experienced was 25Jan2021 and since then she had been fine but all of a sudden on Saturday the 06Feb2021, she started having like muscle pain on her arm, the one she got the shot and Saturday, Sunday and today. Last night she put some kind of cream for the muscle pain relief and little bit better this morning. She enquired if that was normal to have pain after almost so many days after the vaccine. The outcome of the event runny nose, I had a bad day, headache, very tired and very weak was recovered while the outcome of Muscle pain on my arm was recovering. Follow-up attempts completed. No further information expected. Amendment: This follow-up report is being submitted to amend previously reported Information: To delete the event "Off label use in unapproved indication", added breast cancer in the medical history, removed the indication breast cancer for drug bnt162b2 and added COVID-19 immunisation and deleted At Risk classification.
82 2021-07-14 weakness had previous shortness of breath but got much worse after vaccination, heaviness in chest, extreme ... Read more
had previous shortness of breath but got much worse after vaccination, heaviness in chest, extreme fatigue and weakness, wheezing in chest, fuzzy eyesight, can't focus eyes, feels as if eyes are going cross-eyed, muscle weakness, trouble walking, previously had headaches but more frequent and worse since vaccination
82 2021-07-17 tingling Tingling lips; nose and cheeks tingling; Chest tightness; This is a spontaneous report from a contac... Read more
Tingling lips; nose and cheeks tingling; Chest tightness; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in arm right on 28Feb2021 (at the age of 82-year-old) administered at approximately 13:30-13:45 (at the age of 82-year-old) as dose 1, single for COVID-19 immunisation. She did not have prior vaccinations in 4 weeks. Medical history included multiple allergies. she had allergies to Penicillin and Sulfa, since in her 40s. Concomitant medications included (procaine hydrochloride) NOVOCAIN taken for an unspecified indication from 24Feb2021 to an unspecified stop date. She had dental work on Wednesday, 24Feb2021, that included a shot of Novocain. She said she wondered if the Novocain shot had anything to do with the COVID-19 Vaccine causing the tingling in her lips, nose and cheeks, since everything she experienced on 28Feb2021 happened in her face area. She did not have the Novocain dose, NDC, Lot, and Expiration Date. The patient previously took codeine experienced drug allergies. She said her second COVID-19 Vaccine was a couple days before the recommended 21 days between COVID-19 Vaccine doses. The patient experienced tingling lips, nose and cheeks tingling, chest tightness on 28Feb2021 at 22:00. She clarified the tingling in her cheeks was higher up around her cheek bones. She said her cheek tingling was not as strong as the tingling in her lips and nose. She had allergies, and was scared, so she went to the emergency room. She clarified her lips, nose, and cheeks tingling started approximately 5 hours after she received her first COVID-19 Vaccine shot. She said she went to the emergency room about 5 hours after the tingling started, at 22:00 (28Feb2021). Treatment was reported as she was given 1 intramuscular shot of Benadryl while she was in the emergency room. She said she did not know the Benadryl dose or the Benadryl NDC, Lot, and Expiration Date. She clarified the intramuscular Benadryl shot did not effect her lip, nose and cheek tingling at all. She said she was wondering if she should get the second COVID-19 Vaccine shot. She was discharged home from the emergency room after about 2 hours. She said she was given a prescription for oral Benadryl 25mg by mouth, four times a day, as needed, for itching and allergies (30 tablets). She said she did not fill the Benadryl 25mg tablet prescription because she did not think the Benadryl prescription was necessary. she also had felt a little tightening in the center of her upper chest area, towards her throat. She said the chest tightening was very slight, so much so, that she thought the chest tightening maybe her imagination. She said the slight chest tightening went away sooner than her lip, nose, and cheek tingling. The tingling in her lips, nose, and cheeks was much less by the next morning (01Mar2021) and was completely gone by noon (01Mar2021). She said she called her dentist on 01Mar2021 to ask if he thought the Novocain could have contributed to her lips, nose, and cheeks tingling. She said her dentist told her he didn't think the Novocain had anything to do with the tingling she experienced after getting the COVID-19 Vaccine. She said she had Novocain in the past, and Novocain had never caused her to have a reaction. The second COVID-19 Vaccine dose was scheduled for 19Mar2021. The outcome of the event was recovered on 01Mar2021 No follow-up attempts are possible. No further information is expected.
82 2021-07-19 weakness Blurred eyes; Weak; Blood pressure and heart rate off the wall; Blood pressure and heart rate off th... Read more
Blurred eyes; Weak; Blood pressure and heart rate off the wall; Blood pressure and heart rate off the wall; Swelling of the face; Mouth was swollen, just her face and her lips were real swollen; Mouth was swollen, just her face and her lips were real swollen; Tiredness; Had a bowel movement, it was white-looking and smelled like a chemical; Urinating cloudy and with a chemical smell; her eyes were so foggy; Running from nose; Coughing; Having trouble thinking; This is a spontaneous report received from a contactable consumer or other non hcp. A 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported; Expiration Date: Feb2022) via an unspecified route of administration in Arm Right on 05Mar2021 13:20 (age at vaccination 82years old) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure measurement. The patient's concomitant medications were not reported. The patient experienced running from nose, coughing, her eyes were so foggy, urinating cloudy and with a chemical smell on 05Mar2021, blood pressure and heart rate off the wall, swelling of the face, mouth was swollen, just her face and her lips were real swollen, weak, tiredness, had a bowel movement, it was white-looking and smelled like a chemical on 06Mar2021, having trouble thinking on Mar2021, blurred eyes on an unspecified date. She has never reported the side effects that she had, and her daughter told her should have done that. She found her papers and now she is 82 and she got her first shot on 05Mar2021. Patient reported as she felt fine then she got up to leave and her nose started running and it was just like water was pouring out and she made it up to the front and had Kleenexes in her pocket, then started coughing violently, her nose was running violently and trying to come out of her mouth, and she sat down on the chair there and she thought it will pass. she walked out to look for the person that took her out there and she saw exactly where they parked, and her eyes were so foggy she could hardly even see the car. She felt okay then the next day, she got up and her mouth was swollen, just her face and her lips were real swollen. However, her whole face was swollen. she didn't read the side effects to it and thought oh well, it's just some-thing. The next day her blood pressure was going off the wall, her heart rate was horrible, she called the doctor, they wanted her to go to the hospital. The doctor told her to take Benadryl, and Benadryl bothers her, and she said that made her worse. It made her worse. She further clarified made her worse as, it made her heart worse, dizzy and lethargic and she was already tired anyway. she would have been better off not taking it. Her heart rate, which is always normal or very good, and it was like it was going ninety miles an hour. she would get it to slow down then it would feel like it was going 90 miles an hour for a few days then she was really weak and her mind, which at her age she has a very good mind, they tested that, she was having trouble thinking. she guesses she would call it foggy. she wanted to sit down and pay bills, but she couldn't even concentrate. Her question is she had the first shot but now she's afraid to get the second shot because of what it did the first time around. she's afraid it will do double; they say it's a worse reaction. The card that she had, she said that her nose was running so bad, she shoved the card in her purse and looked in her purse later and she can't even find that card. She will say she can't get the flu shot because in the past, she had a very bad reaction from the flu shot, she was questioning whether to get this vaccine or not. It wasn't a live vaccine. she is scared to death of the virus and her kids wanted her to get it now, hurry, hurry, and she thought she would try it. Since she has reactions to suspect product, she's concerned about getting the second one. That was 10 years or more that she had the bad reaction. She is a person that her body is very sensitive. Her doctor has trouble getting medicines she can take. She has a bad back, she has tired every painkiller there is and she can't take any of them, they are worse than the pain. She has trouble seeing too. She keeps every-thing up, they don't give as many papers and it changes every week. She doesn't know how the people in the medical profession can take it, she imagines they change things on them overnight. She has macular. She couldn't understand with that shot why she could see whenever she went in and after she got the shot then everything was fogged when she came outside, but she knows it still wasn't as bad as getting the virus. She's still weak, but she's gotten better. They said she could leave, her nose started running and she started coughing. The girl said is she okay and thought she was, and she made it out then started coughing violently and that water was almost drowning her. She sat down in the chair, and it finally calmed down and got in the car, kept wiping that water with paper towels in her car and coughing and by the time she got home it was slowed down. She is more tired than usual, and her eyes haven't cleared up as good as they should. She doesn't know what that happened, it just came out of there and thought well god what has happened to her eyes. She has an appointment with the Optometrist at the end of April. Another thing she forgot, they are going to think she's looney, she started urinating that evening and she thought, this is not good, something was going on with her kidneys, because it was cloudy-like and had a chemical smell and then the next morning, she still smelled the same thing and her bowels were the same way, just smelled this chemical. That evening her urine was like that and the next morning she noticed it was like that into the next day, whatever was in there had to come out and then her urine and things cleared up. Started on 05Mar2021, that evening, when she urinated before she went to bed it was cloudy and had this chemical smell, maybe it was something she ate or something. The next morning, she urinated a lot and it was cloudy and the bowel movement, it was white-looking and smelled like the chemical and cleared up. She has recovered completely after whatever was in there got out the next day. She states she was okay after she did all that, she cleared up. The clinical outcome of the event blurred eyes was unknown, another events week, her eyes were so foggy, having trouble thinking, tiredness was recovering, and event running from nose, coughing recovered on 05Mar2021, blood pressure and heart rate off the wall was recovered on 09Mar2021, swelling of the face, mouth was swollen, just her face and her lips were real swollen was recovered on an unspecified date Mar2021, urinating cloudy and with a chemical smell and had a bowel movement, it was white-looking and smelled like a chemical was recovered on 06Mar2021. Therapeutic measures were taken as a result of swelling of the face (swelling face), mouth was swollen, just her face and her lips were real swollen (mouth swelling), mouth was swollen, just her face and her lips were real swollen (lip swelling). Information on Lot/Batch number was available. Additional information has been requested. Follow-up (05Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. No follow-up attempts are possible, information about lot/batch number cannot be obtained.
82 2021-07-22 weakness 83 y/o female, PMHx of Afib, HTN, DM, colon CA, presenting with worsening SOB and weakness related t... Read more
83 y/o female, PMHx of Afib, HTN, DM, colon CA, presenting with worsening SOB and weakness related to Covid19 infection. Pt was diagnosed with Covid on 1/22/21 and managed symptoms at home. Was sent to ER by home health due to low O2 sat without oxygen. Hypoxic at 86% on admission. Pt treated with supportive measures. Pt was discharged to skilled nursing facility on 2/1/21.
82 2021-07-27 weakness felt a 50 cent piece size hard lump on her head that hurts and is hard to the touch; Bad Headache; L... Read more
felt a 50 cent piece size hard lump on her head that hurts and is hard to the touch; Bad Headache; Legs felt Weak; Tiredness; This is a spontaneous report from a contactable consumer (Patient). A 82-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number not provided), via an unspecified route of administration on 18Mar2021 at 13:30 (at the age of 82-year-old) into left arm as a single dose for COVID-19 immunization at doctors Office.The patient had received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number EN6203), via an unspecified route of administration on 22Feb2021 (at the age of 81-year-old) in to Left arm as a single dose for COVID-19 immunization at doctor Office. The patient medical history included ongoing Asthma, COVID-19 from Dec2020 to an unknown date. Concomitant medication(s) included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for asthma from an unspecified start date and ongoing. The patient previously took flu shot every year and had no issues with it. On 18Mar2021, the patient experienced Tiredness. On 19Mar2021, the patient experienced Bad Headache and Legs felt Weak. On 21Mar2021, the patient felt a 50-cent piece size hard lump on her head that hurts and is hard to the touch. It was reported that she is calling about the Pfizer Vaccine; verified Pfizer Covid Vaccine. Patient stated that she had her second shot on Thursday 18Mar2021. She states that on Sunday, she was rubbing her head and she felt a 50-cent piece size hard lump on her head. She states that she called the doctor office yesterday and explained it to them and they got back to her today and they told her that they weren't aware of anything like that, it might be something that they didn't know. She states they said it may be another reaction that wasn't on the list. She states that they told her to call Pfizer to see if it has been reported. She states that she is calling to find out if that is a side effect and what she can do. She states that the lump hurts and is hard to the touch. She states that (Name withheld) is the one that gave her the shot and she got the first one there too. States that she has been going there for quite a few years. She states that he knows about this and is the one that told her to call Pfizer. On Thursday, she came home and went to bed at 10:00p.m. She states she remember thinking she can't wait until she flops in bed. She states that her daughter woke her up the next afternoon around 4:00p.m. She states that she felt like going back to sleep after she woke up in the afternoon and would dose off. She states it was gone by 20Mar2021.she also had a bad headache that started on 19Mar2021. She states that she took two Tylenol, and it was gone later that day on 19Mar2021.Her legs felt weak after she woke up in the afternoon on 19Mar2021. States it resolved by 20Mar2021.She had a mild case of COVID in December and she was in the hospital for 2 days. She states the doctor said to wait 3 months before getting the first dose. She also has a puffer in her pocketbook for emergency asthma attacks. The patient was not visited to emergency room and physician office for the events. The patient did not receive any vaccine Prior Vaccinations (within 4 weeks). The outcome of the events was recovered for Bad Headache on 19Mar2021, recovered for Tiredness and Legs felt Weak on 20Mar2021, not recovered for felt a 50 cent piece size hard lump on her head that hurts and is hard to the touch. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
82 2021-07-28 face paralysis I63.9 - Acute ischemic stroke (CMS/HCC) R29.810 - Facial weakness
82 2021-07-28 face paralysis R29.90 - Stroke-like symptom I63.9 - Cerebrovascular accident aborted by administration of thromboly... Read more
R29.90 - Stroke-like symptom I63.9 - Cerebrovascular accident aborted by administration of thrombolytic agent (CMS/HCC) R29.810 - Facial weakness
82 2021-07-28 feeling cold, tingling, weakness all over prickly skin; sweating all over; low pulse; feeling cold; vomiting; Diarrhea; feeling very ... Read more
all over prickly skin; sweating all over; low pulse; feeling cold; vomiting; Diarrhea; feeling very weak.; This is a spontaneous report from a contactable consumer, the patient. A 82-year-old female non-pregnant patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 31Mar2021 at 12:30 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. Medical history included cardiovascular disease and thyroid. The patient received unspecified medication within two weeks of vaccination. The patient previously took PLAVAX on unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 21:00 the patient experienced all over prickly skin, sweating all over, low pulse, feeling cold, vomiting, diarrhea and feeling very weak. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event all over prickly skin, sweating all over, low pulse, feeling cold, vomiting, diarrhea and feeling very weak was recovering. No follow-up attempts are needed. No further information is expected.
83 2021-01-03 pain in extremity Patient reporting sore arm, diarrhea and nausea every once in a while since 1/2/2021.
83 2021-01-05 tension headache APPROXIMATELY 1 HOUR POST VACCINATION, DEVELOPED TIGHTNESS AROUND HEAD "RUBBER BAND AROUND HEAD". RE... Read more
APPROXIMATELY 1 HOUR POST VACCINATION, DEVELOPED TIGHTNESS AROUND HEAD "RUBBER BAND AROUND HEAD". RESOLVED AFTER ABOUT 1 HOUR.
83 2021-01-12 tension headache DEVELOPED TIGHTNESS AROUND HEAD LASTING 1 HOUR.
83 2021-01-12 unresponsive to stimuli New onset altered mental status after fall. Per son, she was found in bed, unresponsive at around 12... Read more
New onset altered mental status after fall. Per son, she was found in bed, unresponsive at around 12:15 AM on 1/10 by her husband. Brought to the emergency room and admitted, Began treatment for UTI w/ CTX. Discharged 1/11/21 with f/u appointments
83 2021-01-13 unresponsive to stimuli 83yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, the patient re... Read more
83yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, the patient reportedly got up in the middle of the night with c/o feeling "blah", restlessness, and nausea. VS normal, no other s/sx. At 4:15am, the patient was asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient unresponsive, no pulse, no respirations. GNA notified the nurse. At 6:03am, CPR started and EMS called. At 6:15am, EMS arrived and took over. At or around 6:30am, EMT called time of death
83 2021-01-14 burning sensation RED RASH SPOT ON BACK OF RIGHT THIGH, BURNING SENSATION
83 2021-01-16 tremor Tinnitus Tremors Diaphoresis Sob Epipen given, paramedics called, sx resolved 20 minutes after sx o... Read more
Tinnitus Tremors Diaphoresis Sob Epipen given, paramedics called, sx resolved 20 minutes after sx onset
83 2021-01-18 feeling hot legs from the knees down especially kept patient awake at night from itching; Patient got it in the ... Read more
legs from the knees down especially kept patient awake at night from itching; Patient got it in the upper left arm in the muscle it was not hurt when it went in but it was kind of hurting now; Reaction on both legs they covered in red spots and at knees it was especially bad/it's more like a color; kept patient awake at night from itching/it woke patient up; red spot over the injection site; also there was a swelling just that gone bad; it was more like a discoloration in skin; Hurting so bad like a waxing kind of stinging and burning; Hurting so bad like a waxing kind of stinging and burning; skin it felt very warm; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK92321), via an unspecified route of administration on 06Jan2021 at single dose at left arm for covid-19 immunization. Medical history included arthritis and lost a couple of inches from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had the Covid-19 shot on 06Jan2021 and had reaction on both legs. They were covered in red spots and at knees it was especially bad, it wasn't like bumps, it wasn't like rash it's more like a color and skin it felt very warm and legs from the knees down especially kept patient awake at night from itching and the itching started on 07Jan2021 night into 08Jan2021 and it woke patient up and patient was just calling at knees. So patient got up and went into bathroom and patient put some anti-itch that's what patient husband had for his allergies. Patient said the spots on knees, the red spots are basically gone but they were still there and the left knees was specially bad and you can feel through pants even that it's warm on these places but when rubbing hands on it you can't feel rash or anything, it was more like a discoloration in skin, there was also a red spot over the injection site, patient would say about the size of a tennis ball and also there was a swelling just that gone bad but and it was okay really but it was there, patient had at a place on belly and it was gone, so let do something else but the discoloration on leg the splotches, patient guess they called splotches not a rash like a pimply rash but just there and they itch something there but it was getting better now. Patient was about 5'4' or maybe 5'4.5', and patient weighed a 141. Patient had 2 Covid test that were negative. Patient got the vaccine at the College. Patient got it in the upper left arm in the muscle it was not hurt when it went in but it was kind of hurting now, but it was okay. Patient put some kind of cream as treatment. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient was going to because it was hurting so bad like a waxing kind of stinging and burning but then patient just put more cream on it and it would stop, it was going to the doctor on 09Jan2021 morning but it was so much less and now patient didn't think she feel any ill effects. Outcome of all events was recovering.
83 2021-01-25 weakness severe nausea, weakness, rigors, shortness of breath
83 2021-01-25 flushing Patient experienced flushing and tachycardia about 15 minutes after vaccine. Patient was sent to ur... Read more
Patient experienced flushing and tachycardia about 15 minutes after vaccine. Patient was sent to urgent care for brief observation and found to be hypertensive as well. Ultimately thought be a large component of anxiety after vaccination, and patient was discharged without complication.
83 2021-01-25 unresponsive to stimuli Patient has a long standing history of CHF and AFib, however, patient had a syncopal episode on 01/2... Read more
Patient has a long standing history of CHF and AFib, however, patient had a syncopal episode on 01/25/2021 in the morning. Per her hospital admission note, she stated that she felt fine, stood up, became dizzy and was able to lower herself to her chair then went unresponsive for a few minutes, but did regain consciousness. When she arrived to the emergency department, she was in atrial fibrillation with RVR with rate in the 140-150s. While the AFib is long standing, the RVR is new and potentially unexplainable. This was resolved with cardizem drip ending at 2220 on 01/25/2021. Alternatively, this patient is being put into VAERS as there are 2 other patients hospitalized with cardiac issues and received vaccine from the same pharmacy with the same lot number.
83 2021-01-27 burning sensation coughing; fatigued / tired; Not felt good/ Not been myself; My body has not been normal like my spec... Read more
coughing; fatigued / tired; Not felt good/ Not been myself; My body has not been normal like my specimen not good and it was dark; I am very irregular with going to bathroom so I have not felt good; Might have ulcer because it burns when I eat anything; Might have ulcer because it burns when I eat anything; I have aches, body aches; Slept like all the way around the clock; This is a spontaneous report from a contactable consumer (the patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot E13246), via an unspecified route of administration on 05Jan2021 (at the age of 83-years old) as a SINGLE DOSE for Covid-19 immunization. Medical history included hypertension, reported as pretty regular, from an unknown date and unknown if ongoing. Family medical history included bleeding ulcer from her mother. Concomitant medications included benazepril and felodipine for hypertension. The patient experienced my body has not been normal like my specimen not good and it was dark; i am very irregular with going to bathroom so i have not felt good; might have ulcer because it burns when i eat anything; I have aches, body aches; slept like all the way around the clock all in Jan2021; I was coughing and felt fatigued / tired on 15Jan2021; and not felt good/ not been myself in Jan2021. The patient underwent lab tests and procedures which included body temperature which was checked 3 times with no fever on an unknown date. Therapeutic measures were taken as a result of slept like all the way around the clock which included ibuprofen (ADVIL). The outcome of the events bowel movement irregularity, burning sensation, ulcer, pain, hypersomnia, cough, fatigue and malaise was unknown.
83 2021-01-28 involuntary muscle movements, feeling jittery Resident complain of not feeling well. Upon entering her room, she was jittering, witnessed some unc... Read more
Resident complain of not feeling well. Upon entering her room, she was jittering, witnessed some uncontrollable movement nausea and vomited once. she called her son and said that she had the second covid shot yesterday and since then she is not feeling well. VS stable, no fever, MD called, resident currently in bed alert and oriented x 3, no change in mental status.
83 2021-01-31 feeling cold Vaccine administered to pt at 1805. Pt observed for 30 minutes due to history of allergies. AT 1835 ... Read more
Vaccine administered to pt at 1805. Pt observed for 30 minutes due to history of allergies. AT 1835 pt reported feeling "cold, nauseous" and reported feeling "every side effect on the handout." Staff provided juice and graham cracker and assessed vitals. Vitals within patient's baseline. Pt then reported "back pain" and described ita s "squeezing" Staff performed 12 lead EKG. EKG results within patient's baseline. Pt kept for another 10 mins and observed. Staff advised pt to contact doctor and go to ER if symptoms persist. Pt reported feeling better and comfortable with going home. Pt went home after a total of 45 minutes of observation with daughter.
83 2021-01-31 tremor, burning sensation swollen lips; tightening of her neck was more intense after receiving the vaccine, it felt like the ... Read more
swollen lips; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; chills and shaking; chills and shaking; red dot on the inside of her throat; she took the Benadryl thinking it was an allergic reaction; swelling on left side where the nodule was removed; burning sensation in her left arm; ear pain; nausea; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on Left deltoid (upper left arm) on 13Jan2021 14:00 at single dose to prevent COVID. Medical history included sulfa drug reaction, high blood pressure diagnosed in 1970s or 1980s (States she was in the hospital in the 70s or 80s. She has high blood pressure which has been difficult to control, she is seeing a cardiologist and he is content with her blood pressure readings, her diastolic is normal), incontinence, thyroid nodule surgery a year ago (2020), thyroid nodule, ten operations in the last 3 years, tightening in her neck repeatedly since her thyroid nodule surgery, scratchy throat problems since a week prior to getting the vaccine (from Jan2021) and post nasal drip and she has had that for years and when they operated nothing worked. The patient's concomitant medications were not reported. The patient previously took cipro where she could not breathe. She does not have lot, ndc or expiration date to provide for any of the medications mentioned that she had a reaction to. She took the Asiatic flu shot in 1958 (as reported), she had a reaction and high fever, weak and pale. This occurred when she was 19 years old. She took the Pfizer covid 19 shot last Wednesday. She stated that it could be her but she got a few of the reported side effects. What she found most important was that she had swollen lips that started about an hour after receiving the vaccine. Last night (13Jan2021) she got the chills and was shaking during the night. She had mild chills in the last few days, during the night she was shaking from the chills but it may have been cold at night, reporting the chills have subsided but she can feel it a little bit. In Jan2021, she felt a burning sensation in her left arm which lasted about two minutes. She got a piercing earache in her left ear for about two minutes and then it went away. She experienced nausea within two minutes, but she ate the ginger candy she had in her purse and her nausea went away. She could have something else too since she has a red dot on the inside of her throat. She did not see it was red before last night (13Jan2021). She took Benadryl on Wednesday afternoon after she called the doctor's office, she took the Benadryl thinking it was an allergic reaction, her swollen lips seemed like it was improved but now it was minor. She has had the tightening in her neck repeatedly since her thyroid nodule surgery but she felt the tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening, it is sort of still ongoing but states it has sort of improved. Patient also mentioned swelling on left side where the nodule was removed. She was asking if she should get the second dose. She has an appointment for her second dose. She has never had much problems till she was 80. Her husband tested negative for covid and she tested negative in Aug2020 prior to one of her surgeries. Patient stated that she is 83 but she is biologically younger. She felt pretty good normally. The events did not require emergency room visit or physician office visit. No prior vaccinations (within 4 weeks). The outcome of the events burning sensation in her left arm, ear pain and nausea was recovered in Jan2021; Swollen lips, tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening, chills was recovering; and unknown for the other events. Information about batch/lot number has been requested.
83 2021-02-01 facial paralysis, mild one side paralysis, numbness stroke-like symptom; Left arm droop; no feeling on left side; loss of mobility in left arm; droop on... Read more
stroke-like symptom; Left arm droop; no feeling on left side; loss of mobility in left arm; droop on left side of face; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: Ek4176) via an unspecified route of administration on 16Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. Medical history included blood pressure needs controlling and allergies: penicillin. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included nebivolol hydrochloride (BYSTOLIC), terazosin, famotidine, olmesartan (reported as olmsartan), amlodipine, and atorvastatin calcium (ATORVASTIN). Facility where the most recent COVID-19 vaccine was administered at nursing home/senior living facility. The patient was not pregnant at the time of vaccination. On Tuesday 19Jan2021 at 5 am, patient had stroke-like symptom: left arm droop, no feeling on left side, loss of mobility in left arm, droop on left side of face. The event resulted in emergency room/department or urgent care, and hospitalization. The event was reported as serious with seriousness criteria of caused/prolonged hospitalization. It was unknown if treatment received for event. The outcome of event was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
83 2021-02-03 pain in extremity Tired; Dizzy; unstable; shoulder/injection site pain; shoulder/injection site pain; Arm pain; This i... Read more
Tired; Dizzy; unstable; shoulder/injection site pain; shoulder/injection site pain; Arm pain; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 15Jan2021 (at the age of 83-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shoulder/injection site pain and arm pain in Jan2021 and tired, dizzy, and unstable on 16Jan2021. The clinical course was reported as follows: The patient initially experienced shoulder/injection site pain and arm pain. On the next day after vaccination, she felt tired, dizzy and unstable. The day after was much better and on the fourth day after vaccination, she was back to normal. The clinical outcome of shoulder/injection site pain, arm pain, tired, dizzy, and unstable was recovered on 18Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
83 2021-02-03 seizure Began with vomiting and diarrhea. C/O chest pain. Bradycardia. Hypotension. 2 seizures in 45 minute... Read more
Began with vomiting and diarrhea. C/O chest pain. Bradycardia. Hypotension. 2 seizures in 45 minutes after not having one in years. We gave fluids. Gave Zofran. Comfort measures. Pt passed at midnight. Was completely fine one day before. Had minimal issues with COVID though did have a pneumonia that was treated w ATB early on and resolved.
83 2021-02-04 discomfort Extreme pain in right knee joint which has had a total knee replacement which was done almost 2 yea... Read more
Extreme pain in right knee joint which has had a total knee replacement which was done almost 2 years ago. The pain subsided after about 2 days. I always have some discomfort of this knee, but the pain I experienced after the vaccine was much different.
83 2021-02-04 pain in extremity Symptoms started 12 hrs. after vaccination including, 100.7 temperature, nausea, headache, fatigue,... Read more
Symptoms started 12 hrs. after vaccination including, 100.7 temperature, nausea, headache, fatigue, pain in left upper arm, dry cough. Temperature 98.6 at 8am 02/05 all symptoms have subsided except malaise.
83 2021-02-05 muscle spasms, pain in extremity Severe pain from cramping in inner thigh of right leg, unable to walk.
83 2021-02-06 unresponsive to stimuli Severe headache leading to disorientation and unresponsive condition requiring hospitalization.
83 2021-02-07 inability to speak, weakness My mom received the Covid 19 vaccine on Jan 5, 2021 and became very about a week later. I was inform... Read more
My mom received the Covid 19 vaccine on Jan 5, 2021 and became very about a week later. I was informed that she tested positive for Covid 19 on January 14th. One January 17th she became very tired and weak and would not eat. Hospice called me and told me that she was in a decline state. I saw her on January 25 and 26 and she was just sleeping and could not open her eyes. Her vitals were good and she seemed to understand when I talked to her - she would squeeze my hand and moan but she could not talk or open her eyes. My mom passed away on January 27, 2021 just 22 days after receiving the Covid 19 vaccine. She was very think to begin with and being to weak and tired to eat resulted in her losing even more weight. Some of the other residents were given fluids to help and they recovered. My mom was not given fluids. I believe there were 20 deaths in her care home for the month of January when they vaccinated. This was an alarming number of deaths for the home. The facility had very few Covid deaths in 2019 and 2020. I asked every week if they had any Covid and or Covid deaths and this amount was shocking to me and the workers there.
83 2021-02-07 numbness 12 days after first vaccination: Dizziness; high blood pressure; nearly passed out; right arm numbn... Read more
12 days after first vaccination: Dizziness; high blood pressure; nearly passed out; right arm numbness; inability to grip or pick up items with fingers; feeling of "lopsidedness"; unsteady on feet, requiring assistance to walk. Primary care physician recommended ER visit where possible stroke was diagnosed. Hospital MRI confirmed: " Left acute arterial ischemic stroke, MCA (Middle cerebral artery)" . Spent 2 days in hospital with high blood pressure, dizziness. Residual right finger numbness upon release.
83 2021-02-09 pain in extremity developed a back ache; pain under her arm; armpit pain; a rash from her elbow up; This is a spontane... Read more
developed a back ache; pain under her arm; armpit pain; a rash from her elbow up; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. An 83-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 12:30-13:00 at single dose in left arm for COVID-19 immunisation (over the age, senior citizen). Lot number was EL8982. Medical history included diagnosed allergies, Compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity), high blood pressure, cholesterol. Concomitant medications included medicines for high blood pressure and cholesterol. Patient reported that she took suspect vaccine and for 4 days she felt fine but then in Jan2021 she developed a backache (just below the shoulder; it was really bad and very uncomfortable, on 17Jan or 18Jan, as reported), pain under arm, ache under arm pit (reportedly as worsening) and a rash from her elbow up. Patient thought after a couple days pain would be gone; it was just as bad as when it started. The patient received TYLENOL in Jan2021 and ongoing for pain, but it did not work. The patient did not visit emergency room or physician due to the events. The outcome of rash was unknown, the patient did not recover from other events.
83 2021-02-10 weakness --Patient (and patient's husband) report that patient was given 2 doses of Pfizer Covid 19 vaccine ... Read more
--Patient (and patient's husband) report that patient was given 2 doses of Pfizer Covid 19 vaccine 6 days apart at the Health Department. --First dose: 2/3/21. Second dose: 2/9/21 --Patient was admitted to hospital on the evening of 2/9/21 with weakness, shortness of breath "feeling winded". --Patient reports feeling bad and coughing 2-3 days before being vaccinated and does NOT believe her admission to the hospital was associated with the vaccine. --County health department has been notified.
83 2021-02-10 brain damage Systemic: Other- encephalopathy
83 2021-02-11 pain in extremity I developed a very sore arm. It swelled around the injection site, turned red, formed a hard lump a... Read more
I developed a very sore arm. It swelled around the injection site, turned red, formed a hard lump and was hot to the touch.. This has lasted all week but it has become progressively less. I am very active (for my age). I swim 1/2 mile laps twice a week; do regular exercises for balance and to relieve back pain and regularly do tai chi. I think this exercise, especially with my arms has helped reduce the symptoms. The symptom wasn't serious and did not impede my activities. I am sending this because I thought it might be helpful.
83 2021-02-12 pain in extremity Very sick feeling, muscle aches, chills, sleepy, tired, arm pain for 28 hours after vaccine. In bed... Read more
Very sick feeling, muscle aches, chills, sleepy, tired, arm pain for 28 hours after vaccine. In bed all day.
83 2021-02-12 unresponsive to stimuli Patient received his first dose of Covid vaccine on Jan. 30, 2021. On Jan 31, 2021 at 6:08 AM, patie... Read more
Patient received his first dose of Covid vaccine on Jan. 30, 2021. On Jan 31, 2021 at 6:08 AM, patient noted unresponsive per facility. Code blue was called and 911 dispatched. He expired in the ER.
83 2021-02-13 tingling, weakness RECEIVED PFIZER COVID VACCINE ON 02/04/2021 REPORTED TO ED ON 02/13/2021 WITH NECK/BACK PAIN, DIFFIC... Read more
RECEIVED PFIZER COVID VACCINE ON 02/04/2021 REPORTED TO ED ON 02/13/2021 WITH NECK/BACK PAIN, DIFFICULTY SWALLOWING, SORE THROAT, SOA, WEAKNESS/TINGLING IN BLE. ADMITTED ON 02/13/21 FOR DIAGNOSIS OF WEAKNESS, HYPOKALEMIA, CARDIAC ENZYMES ELEVATED, CHF, AND LEUKOCYTOSIS.
83 2021-02-23 burning sensation She thought she was going to pass out; felt like she was going to faint; chin felt funny; face was r... Read more
She thought she was going to pass out; felt like she was going to faint; chin felt funny; face was red; face was burning; This is a spontaneous report from a contactable consumer(patient). An 83-year-old female patient received first dose of BNT162B2(Covid-19 vaccine, lot number EL8982), via an unspecified route of administration on 27Jan2021 10:00 at single dose, left arm for protection from virus, vitamin D(lot number 15070802 with expiration date Jun2023, Non-Pfizer product, manufacturer: 21st Century), orally from 2019 and ongoing at 2000 iU, daily, (25 mcg/1000 IU, takes 2 by mouth daily) for bones, vitamin b complex (B COMPLEX, lot number 14704704 with expiration date Apr2023, Non-Pfizer product, manufacturer: 21st Century), orally from 2019 and ongoing at unknown dose, daily, (2 by mouth daily) for energy, digoxin(Non- Pfizer product), orally from Jun2019 and ongoing at 0.125 mg, daily to slow the heartbeat, rosuvastatin(Non- Pfizer product), orally from 2019 and ongoing at 20 mg, daily to lower cholesterol. Medical history included high blood pressure, blood thinner, low thyroid. Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ) from 2019 and ongoing for high blood pressure, rivaroxaban (XARELTO) from Nov2020 and ongoing as blood thinner, levothyroxine from an unknown date and from Nov2020 and ongoing for low thyroid(had been taking for 25 years or more). History of all previous immunization with the Pfizer vaccine considered as suspect reported as None. Prior Vaccinations (within 4 weeks) reported as None. The patient experienced felt like she was going to faint on 30Jan2021 with outcome of recovered on 30Jan2021, chin felt funny on 30Jan2021 with outcome of recovered 30Jan2021, face was red on 30Jan2021 with outcome of unknown, face was burning on 30Jan2021 with outcome of recovered on 30Jan2021. Caller was asking if she should get the second shot. She went to her doctor and was told it was ok if she got the second shot. The doctor said it was too far between the shot and the reactions for it to be the shot. She received the vaccine on 27Jan2021. On Saturday morning she took Vitamin D, B complex, Digoxin and Rosuvastatin. Twenty minutes later her chin felt funny. Her face was red and burning. She felt like she was going to faint. She got some ice and washed her face. She took 2 baby aspirin. She asked her doctor if she was allergic to the vaccine. Her doctor said the time between getting the vaccine and the events were too far between. She thought she was going to pass out. She felt better after washing her face with ice. She was her face for 30-45 minutes with ice water. She took apixaban (ELIQUIS) before and her chin felt funny. She added that her blood pressure went up and she had trembles. She felt dizzy. Clarified that she felt that way prior to taking the vaccine. At first she didn't think to take her blood pressure. When she took it the reading was 165/79. At 3:00 pm the reading was 162/79. At 6:00 pm the reading was down to 150/79. The trembles started two hours after she took her medications. When providing product details she stated she took two Vitamin D. The label indicated to take one. When asking for indication caller asked what does Vitamin D do? She was able to answer herself. Product is filled in a pharmacy bottle and does not include NDC, Lot or expiry. Prior to taking rivaroxaban (XARELTO), she was taking apixaban (ELIQUIS) 5 mg twice daily. Lot: ABL8694A, Expiry: Dec2022, It came from another country. She was sure she was allergic to it because she had a rash. That was when she was switched to rivaroxaban. She was taking levothyroxine 100 mcg until she turned 82. In Jan2021, the dose was changed to 112 mcg daily. Her last thyroid level was high on the test with a result of 7.46. The dose was changed to 112 mcg daily. Initially caller gave consent to contact her physician. She changed her mind stating she didn't want her doctor to think she was going over her head. She was worried and frightened at the time because something happened to her. She can't remember if her face was swollen. She drank some ice cold water and took two baby aspirins. She knew she needed to flush her system. She just wanted to make she was safe in getting the shot. Her doctor told her to take diphenhydramine hydrochloride (BENADRYL) if she ever felt that way. She felt fine after getting the shot and the few days after getting it. She wanted to get the shot. Events resulted in physician office visit. The action taken in response to the events for vitamin D, vitamin b complex, digoxin, rosuvastatin was dose not changed. The outcome of event "She thought she was going to pass out" was unknown.
83 2021-02-23 pain in extremity she woke up and noticed everything was spinning; Dizzy; sore arm after the shot.; Swollen arm; This ... Read more
she woke up and noticed everything was spinning; Dizzy; sore arm after the shot.; Swollen arm; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on his right arm, via an unspecified route of administration on 22Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included blood pressure high and surgery. There were no concomitant medications. Historical vaccine included a flu shot for flu immunization and experienced arm is sore and pain. The patient reported she got the COVID shot last Friday at 3pm. That night she woke up at 2am and everything was spinning. She is better now but not completely. If she lies down and gets up or turns her head a certain way, she gets dizzy. She had a swollen arm and sore arm after the shot. No treatment was received for the events. The outcome of the events swollen arm and sore arm was unknown while recovering for the other events.
83 2021-02-24 unresponsive to stimuli, facial paralysis Patient resides in an assisted living facility and received the second COVID-19 vaccination. She ex... Read more
Patient resides in an assisted living facility and received the second COVID-19 vaccination. She experienced fatigue in the morning following vaccination. She fell on 2/22/21. Ambulance was called and she was transported to the hospital. Initial symptoms included fever of 101 F, disorientation, left face droop, unresponsive to commands and loss of memory.
83 2021-02-27 burning sensation I have a muscle disease, Polymyalgia Rheumatica ; side effects : extreme muscle pain when standing ,... Read more
I have a muscle disease, Polymyalgia Rheumatica ; side effects : extreme muscle pain when standing , and walking experienced with both doses of vaccine (2/3/21 and 2/24/21) (usual prednisone 8mg does not help the pain) went to urologist Mon Feb 8 for burning, urinary tract, no infection; (nurse practitioner said was side effect of another patient. ) this burning I experienced with the first dose of vaccine (2/3/21); burning lasted two weeks Muscle pain experienced with both doses of vaccine took AZC pills for urinary tract burning.
83 2021-02-28 pain in extremity Patient received the injection approximately 1:27PM on Friday, February 26, 2021. She felt fine unt... Read more
Patient received the injection approximately 1:27PM on Friday, February 26, 2021. She felt fine until about 8PM Friday, Feb 26. At that time, she had feeling of malaise but did not check for fever. She went to bed and fell asleep. Upon arising on Saturday, February 27, 2021, she felt feverish and had a backache. Her fever was first checked about 11:30AM by her son and it was 101 degrees. During the afternoon, about 3PM, she ran a higher fever (102 degrees). The family consulted her primary care physician, who advised hydration and a Tylenol. After talking with the physician, about 4pm, the family gave her a 500 mg Tylenol, which brought the fever down to just under 100 degrees by 8pm Saturday night. She also had aching legs at that time. but no longer had a backache. She slept Saturday night and awakened on Sunday, Feb 28, with a fever of 99 degrees. Around Noon another Tylenol 500 mg tablet was administered. During Sunday afternoon, the fever dropped to around 98.2 (Patient has a normal temperature of 97.3 or 97.4, well documented). On Monday, March 1, 2021, at 11:00am, her temperature was normal, 97.4. She said she still felt tired and her legs "don't feel quite right". However, our family feels she is doing much better and she has enough energy to do some of her normal activities and participate in conversation.
83 2021-03-01 pain in extremity After the first vaccine on 2/4/21 in left arm pain subsided on day 3 Mild pain appeared 2 weeks l... Read more
After the first vaccine on 2/4/21 in left arm pain subsided on day 3 Mild pain appeared 2 weeks later. After the second dose in right arm on 2/25/21 left arm pain rapidly intensified without physical Sxs, interfering with sleep and normal activity. Worse with sitting, lying on either side , radiating into the shoulder. Nerve like pain but also point tenderness in several areas. Present without change niw almost for one week.
83 2021-03-02 weakness fractured T12; unable to walk on own; Fell; largely stopped eating and drinking; enfeebled; This is ... Read more
fractured T12; unable to walk on own; Fell; largely stopped eating and drinking; enfeebled; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: el9269), via an unspecified route of administration at left arm on 02Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included T-cell large granular lymphocytic (tCell LGL), type 2 diabetes and high blood pressure. No known allergies. No COVID prior vaccination. The patient is not pregnant at the time of vaccination. No other vaccine in four weeks. There were other medications in two weeks (unspecified). Within a week, patient was unable to walk on own. She fell and fractured T12. On 02Feb2021, she walked on her own to the car, got in the car, then out of the car, walked to the injection site, including standing in a long line, and walked back to the car. She was aware, recognized people and places, and walked from the car to her home. On 05Feb2021 12:00 (also reported as 'during 02Feb2021 thru 08Feb2021), she largely stopped eating and drinking. Within the week on 05Feb2021 12:00, she was enfeebled. At about 01:30 on 08Feb2021, she fell and fractured her back. She is now awaiting acceptance at a rehab facility. The events unable to walk on own and fractured T12 resulted to hospitalization and disability or permanent damage. The patient was hospitalized for 4 days. The events required Emergency room/department or urgent care visit. Various medical tests and treatments were administered as treatment for the events. Patient tested for COVID post vaccination. Covid test post vaccination on 11Feb2021: (covid test type post vaccination: Unknown) Negative. The outcome of the events was not recovered.
83 2021-03-02 pain in extremity she was not feeling well/she just has not felt good, just have felt blah; just can't taste anything;... Read more
she was not feeling well/she just has not felt good, just have felt blah; just can't taste anything; pain in her arm; Injection site did have a little pain; Tiredness; Muscle pain; This is a spontaneous report from a contactable consumer (patient herself). An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262), via an unspecified route of administration, on 28Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 08Jan2021 for covid-19 immunization and experienced couldn't taste anything. The patient called about the vaccine as she was having some effects. She stated she got the first shot on 08Jan2021 and, last 28Jan2021 she got the second shot. She informed she was given a "paper" to tell her of the effects that one might possibly have when getting the shot, and then she checked all of those. On 30Jan2021, 2 days after the shot, she was not feeling well. She stated her injection site did have a little pain on Jan2021, but it was okay, it went away the next day. She also had on Jan2021 some tiredness and muscle pain which was on there; other than that, she just has not felt good, just have felt blah. She informed that her lymph nodes were not swollen, and she has not been nauseated or have had any of these things written on the paper. She also informed having read on the paper that "the people with Covid-19 and it gave the symptoms of people with COVID 19 and one of them was loss of taste, and smell was okay". She then added that after she got her first shot, she noticed once in a while she couldn't taste anything but that wasn't all the time. But now, since she got the second shot, it seemed like all day yesterday, 30Jan2021, and this morning also, that she just can't taste anything. Then she stated "So, my problem is, would that be a result of the shot?" She stated she was feeling a little bit better today other than that, her mouth - she can't taste anything. Also, yesterday, she took an extra strength Tylenol every 4 hours to try to help with the pain in her arm on Jan2021; but she has not taken any today. She was just trying to help her arm feel better. The outcome of the event injection site did have a little pain was recovered on Jan2021. The outcome of the event she was not feeling well/she just has not felt good, just have felt blah was recovering. The outcome of the event just can't taste anything was not recovered. While the outcome of all other remaining events was unknown.
83 2021-03-03 weakness Patient was admitted for generalized weakness, observed overnight. Cardiology saw the patient believ... Read more
Patient was admitted for generalized weakness, observed overnight. Cardiology saw the patient believe that patient's weakness could be attributed to borderline hypotension. They will arrange outpatient Holter monitoring. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.
83 2021-03-03 feeling cold fatigued; shooting pains under her armpit close to where she got the shot and the other side/shootin... Read more
fatigued; shooting pains under her armpit close to where she got the shot and the other side/shooting pains in her chest; shooting pains under her armpit close to where she got the shot and the other side/shooting pains in her chest; Chills; stated that she was cold; This is a spontaneous report from a contactable consumer (reporting for herself). A 83-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 28Jan2021 to 28Jan2021 at single dose for COVID-19 immunization. The patient's medical history included allergic mold, yeast and penicillin. Concomitant medications were not reported. On 30Jan2021, the patient experienced fatigued, shooting pains under her armpit close to where she got the shot and the other side, shooting pains in her chest, chills and stated that she was cold. The outcome of the events was unknown. Information about batch/lot number has been requested.
83 2021-03-03 tremor, weakness Pounding in head; Heart pounding; Elevated BP; bouncing off the walls, and going from side-to-side w... Read more
Pounding in head; Heart pounding; Elevated BP; bouncing off the walls, and going from side-to-side when she tried to walk; oxygen saturation level kept dropping; shaking; cold; Weakness; Tiredness; Throat tightness; Dry mouth; This is a spontaneous report initial from a contactable nurse and follow up from a Pfizer-sponsored program. This Nurse (patient) reported for self that the 83-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on 17Feb2021 09:30AM on right arm at single dose for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing Reported she was diagnosed with Rheumatoid Arthritis about 10 years ago, fibromyalgia from an unknown date and unknown if ongoing and stated when the doctor couldn't figure out what was causing her pain, the doctor said she had Fibromyalgia, carotid endarterectomy from 2014, pain in extremity from an unknown date and unknown if ongoing She said she has rheumatoid arthritis, and has had terrible leg pain for a long time. Family Medical History Relevant to AE(s) was not provided. Concomitant medication included cortisone (CORTISONE) for Pain in leg from 10Feb2021 and stated her doctor gave her a Cortisone shot in her right knee to help with her right leg pain. Reported she received a Cortisone shot in her right knee on Wednesday, 10Feb2021. She said the doctor gave her the Cortisone shot in her right knee to see if it would help her right leg pain. She said she has a problem with Cortisone, clarifying the Cortisone keeps her awake. She said the doctor wanted her to have another Cortisone shot in 3 months, and she is not going to take the Cortisone shot because she doesn't like how the Cortisone makes her feel. The patient experienced pounding in head (hospitalization, medically significant), heart pounding (hospitalization, medically significant), elevated bp (hospitalization, medically significant), bouncing off the walls, and going from side-to-side when she tried to walk (hospitalization, medically significant), dry mouth (medically significant) all on 17Feb2021 with outcome of recovering, throat tightness (medically significant) on 18Feb2021 with outcome of recovering, weakness (medically significant) on 19Feb2021 with outcome of not recovered, tiredness (medically significant) on 19Feb2021 with outcome of not recovered, oxygen saturation level kept dropping on an unspecified date with outcome of unknown, shaking on an unspecified date with outcome of unknown , cold on an unspecified date with outcome of unknown. He experienced terrible pain in the leg after the 1st dose and took a marijuana cookie and she was rushed to the ER because she was shaking and cold. The patient was hospitalized for events pounding in head, heart pounding, elevated bp and bouncing off the walls, and going from side-to-side when she tried to walk from 17Feb2021 to 18Feb2021. The nurse states that "I told her up until a Month ago, she was taking care of a huge house and husband that is blind. I've been having the pain in my legs for over a month, doppler was done, and I had an injection in my knee with cortisone, I won't do that again, it keeps me awake at night. There is no diagnosis yet on the pain, have an orthopedic appointment coming up. Caller states, I got the first Pfizer vaccine shot on Wednesday at 9:30 am in right arm. Never so much have felt it. or have not felt anything else since. My friend talked me into eating a marijuana cookie about 5pm that day, and at 6 or 6:30pm, I started feeling terrible, my head was feeling terrible, my heart was pounding, I could hardly walk, my mouth was dry as a bone. we called paramedics, we found out on Friday before the shot that I have a right bundle block. Woke up 4:30 in the morning the Friday before with chest pain. EKG found right bundle block, my blood pressure was 245/105, that night in the ER, they got my blood pressure down and sent me home. Wednesday, I had the covid shot in right arm, at 9:30am, that day about 4:30 - 5:00 had the cookie thing, about 6pm, had to call the paramedics, they kept me in the hospital overnight. because my oxygen saturation kept dropping, down in the 86% or 89%, I don't know. Gave me breathing treatments, CT scan for blood clots in lungs was done, Doppler for blood clots in legs, and a HgbA1C. They did an echo of my chest. I don't know all of the results yet. Even yesterday, in the hospital I felt better, but feel week and tired, while walking the hall in the hospital my Blood pressure went up a little bit. I told the nurse, my head feels like this when my blood pressure is up. They sent me home last night. Today, I am feeling okay. My mouth is still a little dry, got a little better yesterday. My legs are still killing me, I have an appointment with my Cardiologist and Rheumatologist, I have Rheumatoid Arthritis. My question is , the doctor didn't know if it was from the cookie or from the vaccine. I am wondering if I should get the second vaccine." She stated she never had a sore arm after getting the COVID-19 Vaccine. She said she did something stupid after she received the COVID-19 Vaccine. She said she has rheumatoid arthritis, and has had terrible leg pain for a long time. She said her friend talked her into having a cookie that had marijuana in it. She said her leg pain was so severe at the time, she took the cookie with marijuana in it around 4:30PM-5:30PM on 17Feb2021. She said at 7:00PM she was bouncing off the wall (clarified as unsteady, and going from side-to-side when she tried to walk), her head was pounding, her heart was pounding, she was dizzy and shaky. She said she went to the hospital emergency room. She said the hospital kept her overnight because her oxygen saturation level kept dropping. She said she got home from the hospital last night (18Feb2021), clarifying she was discharged from the hospital at 6:00PM. She said she noticed her mouth was very dry when she went to the hospital on 17Feb2021, and her mouth continued to stay very dry all night. Caller asked if she should get the second COVID-19 Vaccine shot after experiencing what she did after receiving the first COVID-19 Vaccine. Reported her leg pain became severe about a month ago, clarifying she has had leg pain for a long time. Reported her blood pressure was up while she was at the hospital, clarifying she had one blood pressure reading of 145/82 that she recalls. She said her blood pressure is pretty normal, and she takes blood pressure medications. She said she believes her heart rate was up too, but was unsure what her heart rate was. Reported a couple days before receiving her first Pfizer COVID-19 Vaccine, she went to her doctor on 12Feb2021 because she was having severe chest pain. She said her doctor did an EKG and told her she had a right bundle branch block. She said her doctor sent her to the hospital Emergency Room. She said while she was in the Emergency Room she had an extremely high blood pressure of 245/105. She said she came home from the Emergency Room on 12Feb2021, and had a couple spells, but was OK. She said she was OK when she went to get her first COVID-19 Vaccine shot on Wednesday, 17Feb2021. Reported she had difficulty reading her COVID-19 Vaccine Immunization Card. She said the Pfizer COVID-19 Vaccine Lot Number looked like EN6200, and there was no NDC Number, or Expiration Date listed on the card. Reported she had blood work done at the hospital. No further details provided. Treatment included she was given Albuterol breathing treatments while in the hospital, along with some other things that she can't remember. Reported she believes her symptoms were medically significant because she was nervous from recently being to the Emergency Room for her severe chest pain a few days before. Reported she did not think her symptoms were from the COVID-19 Vaccine. She said she thought the cookie with marijuana in it caused her symptoms because the symptoms happened about 1-1/2 to 2 hours after she had the cookie with marijuana in it. Reported she feels very weak and tired. Reported yesterday (18Feb2021) while she was in the hospital, her head felt like it was going to explode when the hospital staff tried walking her around. She said she asked the hospital staff to check her blood pressure because her head will feel like that when her blood pressure is up. She said when the hospital staff checked her blood pressure, her blood pressure was elevated. Reported the pain in her legs is driving her crazy, so she called for an appointment with an orthopedist today. Reported she is feeling better, but is still experiencing a tightness in her throat. She clarified she felt the throat tightness on Wednesday, 17Feb2021. She said she has no problem swallowing or eating, but her throat feels tight. Vaccination Facility Type was Hospital. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. AE(s) required a visit to: Emergency Room (admitted to hospital), no Physician Office. Prior Vaccinations (within 4 weeks) was none.; Sender's Comments: The 83-year-old female patient had medical history included rheumatoid arthritis, fibromyalgia and carotid endarterectomy, and was on multiple concomitant drugs. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of the reported events, cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
83 2021-03-06 pain in extremity Mild lightheadedness after injection, observed 15" + 15"more. Ok then, drove home. Usual sore arm ... Read more
Mild lightheadedness after injection, observed 15" + 15"more. Ok then, drove home. Usual sore arm x 2 days, mild nausea, malaise, a little dizziness/light headed off and on x day 2-4. Ok till day 6, woke up with itching and red injection site. Continued increasing itching and redness next two days-- this is day 8 following injection. Still red, itchy, tender area on skin around injection site -- size approximately 2 cm across and 4cm long. Itching feels deeper than skin level, soreness around shoulder joint. No noticeable swelling of lymph nodes. Looked online and appears same as "Covid vaccine arm" reports I read, occurring with both Moderna and Pfizer at times.
83 2021-03-08 feeling hot Redness (4"x6" about 2" below injection site) started 2/26/2021. Noted swelling and warmth but denie... Read more
Redness (4"x6" about 2" below injection site) started 2/26/2021. Noted swelling and warmth but denied pain. Tried benadryl and other creams with no improvement. Ibuprofen seemed to help.
83 2021-03-08 tingling She was on the home from the vaccine and felt tightening of her face, and got home and looked in the... Read more
She was on the home from the vaccine and felt tightening of her face, and got home and looked in the mirror and her face was red. She does have rosacea but this was worse. After she got home she began to feel her heart beating rapidly. She had taken her medications, but about 6:00 PM she took an extra dose of Metoprolol and waited until about 8:00 PM and the rapid heart beat was still there. Her son took her BP and it was extremely high and it was 119/68, pulse 112. At 11:00 her BP was 108/59 with a pulse of 78. She was able to sleep but did feel heaviness the day later and rapid beating had subsided. She is still having the rosacea, tingling, stinging of her face. Her vaccine site was not even sore and he no problems with that. She called her doctor and the nurse called her back, and she has been trying to call the place where she got the vaccine. She was told to make sure what to do before she gets the 2nd shot. She has recovered from the rapid heart beat episode, but the skin stinging of her face is still ongoing.
83 2021-03-11 pain in extremity Pt came to ER on 3/2/2021 with complaints of leg pain after the second COVID shot that were not gett... Read more
Pt came to ER on 3/2/2021 with complaints of leg pain after the second COVID shot that were not getting better.
83 2021-03-14 weakness within 24 hours; near syncope, brain fog, fatigue/weakness, exac of underlying anxiety secondary to ... Read more
within 24 hours; near syncope, brain fog, fatigue/weakness, exac of underlying anxiety secondary to symptoms; these have been episodic. Brought to ER The Four Paramedics that came to take her to the ER stated they were overwhelmed with calls for post covid vaccine problems and that ALL of their vehicles were out on calls many due to this. Agressive workup including CT, EKG, Cardiac monitoring, CTA neck and Brain, Carotid and peripheral dopplers and vascualar surgeon consultation revealed nothing. Told it temporally had to be assoc with the vaccine?? I am reporting so that this can be evaluated for confirmation.
83 2021-03-14 pain in extremity 6 hr. after shot, felt unwell, went to bed, awoke after 12 hours with chills, fever, nausea, arm so ... Read more
6 hr. after shot, felt unwell, went to bed, awoke after 12 hours with chills, fever, nausea, arm so sore I could not move it without excruciating pain. Began forcing fluids as symptoms persisted. Slept almost all of the following two days and nights. Now 3 days have passed, much better now but no appetite, still forcing water and juice. Worse than any flu I have ever had! This was my 2nd shot. After my first shot I had slight fatigue and a sore arm only.
83 2021-03-15 concussion Client had Nausea and dizziness for 3-4 days: then on the 3rd or 4th day client blacked out. Clien... Read more
Client had Nausea and dizziness for 3-4 days: then on the 3rd or 4th day client blacked out. Client informed by her Physician that she had a concussion. On 3-16-2021 on a follow-up call it was reported by her son that she is now fine.
83 2021-03-18 weakness Ground Glass Opaque lung problem; Weak; nausea; diff.breathing; pain on rt.side waist around to back... Read more
Ground Glass Opaque lung problem; Weak; nausea; diff.breathing; pain on rt.side waist around to back,down to lower belly; slight temp almost 100; pain on rt.side waist around to back,down to lower belly; pain on rt.side waist around to back,down to lower belly; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Left Arm on 22Jan2021 10:45 am as SINGLE DOSE for covid-19 immunisation. Medical history included overweight, sleep apnoea syndrome and ongoing shortness of breath. Concomitant medication included levothyroxine strength 125 mcg; triamterene; colecalciferol (VIT.D3) and thiamine (VITAMIN B1). The patient previously took tylenol and experienced drug intolerance (Known allergies: Cannot tolerate anything but Tylenol). No other vaccine in four weeks. Facility type vaccine was Workplace clinic. The patient experienced weak (asthenia) on 23Jan2021 15:00, nausea on 23Jan2021 15:00, diff. breathing (dyspnoea) on 23Jan2021 15:00, pain on rt.side waist around to back, down to lower belly (pain) on an unspecified date in 2021, ground glass opaque lung problem (lung opacity) on an unspecified date, slight temp almost 100 (body temperature increased) on an unspecified date in 2021 and pain on rt.side waist around to back, down to lower belly both on an unspecified date in 2021. AE resulted in [Emergency room/department or urgent care]. Treatment was received for these events (Levofloxacin 500mg). It was reported that Weak, nausea, diff. breathing, urgent care on Fri. 05Feb2021, with pain on rt. side waist around to back, down to lower belly. Contrast Cat Scan showed no signs where pain was, but found Ground Glass Opaque lung problem. Is it safe to take #2 vaccine I'm on oxygen now, slight temp almost 100, usually 97. There was no covid prior vaccination. Patient has covid tested post vaccination as SARS-COV-2 test: negative (Nasopharyngeal) on 05Feb2021. The outcome of events was not recovered.
83 2021-03-18 night sweats positive COVID-19 test with no symptoms; Asymptomatic COVID-19; Eventually develop arrhythmia; valle... Read more
positive COVID-19 test with no symptoms; Asymptomatic COVID-19; Eventually develop arrhythmia; valley fever; chills; night sweats for 1 and half week; rash looked like confetti; low grade temp; I had an irritation in my upper nose; Platelet count was found to be 90/platelet count dropped corrected with in one week; This is a spontaneous report from a contactable consumer, the patient A 83-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown), via an unspecified route of administration on 09Feb2021 (at the age of 83-years-old) as a single dose, for COVID-19 vaccination. The patient medical history includes Atrial Fibrillation. Concomitant medication include Eliquis, Synthroid, Pravastatin, Diltiazem and Dofetilide The patient experienced arrhythmia, valley fever, chills , night sweats, rash looked like confetti, low grade temp, asymptomatic covid-19, had an irritation in my upper nose, platelet count was found to be 90/platelet count dropped corrected with in one week. The clinical course was reported as follows On '04Mar2020' traveled and had an irritation in my upper nose which I later came to understand was caused my asymptomatic COVID-19. Was treated for valley fever with Antifungal med, Eventually developed arrhythmia. Sought treatment at Clinic. Initial diagnosis made at urgent care where platelet count was found to be 90 '1st week in April' 2020 also reported as an event. Treatment was give for Valley Fever. No Treatment was given for Asymptomatic COVID-19 and Platelet count was found to be 90. No hospitalization was involved The patient underwent lab tests that included Platelet count drop/found to be 90 '1st week in April' , Sars-cov-2 test: tested positive on 'last week in March 2020' 'Tested positive for covid 19 in the first quarter of 2020' . The clinical outcome of the event Asymptomatic COVID-19, Drug ineffective, Arrhythmia, chills, night sweats, rash, fever, nasal discomfort were unknown, while Valley fever and Platelet count low was recovered. Consumer inquired if the vaccine might trigger another platelet drop. Did not seem to but second shot next Tuesday 02Mar2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
83 2021-03-19 pain in extremity, weakness, feeling hot Btw 2 & 4 pm flashes of heat/pain in my right leg and legimate pain in my left leg,was constant f... Read more
Btw 2 & 4 pm flashes of heat/pain in my right leg and legimate pain in my left leg,was constant for abt 2 hrs. So paineful could NOT move for abt 2 hrs. Able to drift off to sleep about 6 AM 6:30 am TEMP was 98.9 Finally got up abt 11:00 am with slight headache. Temp at 11:30 am was 98.7 Was completely "wiped" out . Rested the whole day and evening, drinking hot tea and oyster crackers. that eveing very well, about 6 hours. Saturday @ 12:pm Temp was 96.3 about right for me! My observation: Needed to Hydrate BIG TIME, before and after 2nd vax!
83 2021-03-20 pain in extremity sore arm; This is a spontaneous report from a contactable consumer. An 83-year-old female patient re... Read more
sore arm; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number: unknown, Formulation: Solution for injection, Lot number: EL3247, expiration date: unknown), via an unspecified route of administration at the age of 83-years, on 13Jan2021, at 0.3 mL, single dose (dose number: 1) for COVID-19 immunization. The patient's medical history and concomitant medications were none. It was reported that she had no issues with the first vaccine except a sore arm on an unknown date in 2021, got first vaccine on 13Jan2021, sore arm lasted a couple of days, states it was not too bad. The outcome of the event was unknown.
83 2021-03-21 pain in extremity Sore arm for two days. Very painful joints for 3 days, especially hip joints, stiff neck
83 2021-03-23 weakness 83yo F w/ PMH significant for HTN, chronic thrombocythemia, and glaucoma followed by Heme-Onc withou... Read more
83yo F w/ PMH significant for HTN, chronic thrombocythemia, and glaucoma followed by Heme-Onc without treatment who presented to ED 03/15/21 via EMS complaining of generalized weakness. She had felt well and had been in her usual state of health, and was able to cook and enjoy a turkey dinner with 5 individuals on 03/07/21, but on 03/08/21 she began to develop progressive generalized weakness up to the point where she remained in bed for several days. She could not support herself when attempting to rise from bed. She noted poor PO intake with nausea, no vomiting. Loose stools for several days, no noted stool blood. Did endorse waves of lightheadedness and had fallen backwards three times in the prior week, reportedly due to poor balance when standing. She was unable to elaborate regarding the falls but admitted to hitting her head at least once, unable to say if she lost consciousness or if she felt presyncopal symptoms before falling. She had initially presented on 03/12/21 to ED for evaluation, workup negative, labs and imaging normal. CT brain found no acute process. She was sent home with arrangements for home PT. She returned to ED 03/15/21 when symptoms had not improved. In the ED she was found to be afebrile, significantly hypertensive, mildly tachycardic, + orthostatic vital signs. Labs significant for heme occult positive stool, proBNP 397, WBC 10.1, H/H 13.4/39.9, PLT 493, UA neg for infection. COVID neg. CXR found slightly increased interstitial markings. MRI brain found no acute intracranial abnormality. She was evaluated by PT and found to be unsafe to DC home as she could not ambulate without leaning backward and to the right and needed 1-2 assist. She was admitted to HM service for further management. She has remained consistently afebrile. She continues to experience significant gait instability, cognitive slowing, and difficulty with finger-to-nose testing with noted dysmetria, no focal weakness.
83 2021-03-23 weakness progressive shortness of breath; hypoventilation; dysphagia; severe asthenia; mild upper abdominal p... Read more
progressive shortness of breath; hypoventilation; dysphagia; severe asthenia; mild upper abdominal pain; inability to eat; This is a spontaneous report from a contactable physician. An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 14Feb2021 (at the age of 83-years-old) as a single dose for COVID-19 immunization. Medical history included right partial nephrectomy for renal cell carcinoma (RCC) in the remote past, hypertension, obstructive sleep apnea, hypothyroidism, morbid obesity, motion sickness, unspecified allergy as the patient cannot tolerate anything but paracetamol (TYLENOL), acute on chronic respiratory failure secondary to centrilobular emphysema. Ongoing concomitant medications included levothyroxine sodium (LEVOXYL) tablet, meclizine hcl tablet for motion relief and hydrochlorothiazide/ triamterene (DYAZIDE) capsule. The patient previously took paracetamol (TYLENOL). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247) on 22Jan2021 (at the age of 83-years-old) in the left arm and experienced difficulty breathing, ground glass opaque lung problem, weak, nausea, "pain on rt.side waist around to back, down to lower belly", slight temp almost 100. On an unspecified date in Feb2021, the patient presented to the hospital with progressive shortness of breath and inability to eat for two days. The patient reportedly received the second dose of BNT162B2 four days prior to coming to the emergency room (ER). In the ER, the patient reported severe asthenia, mild upper abdominal pain and dysphagia, all as of an unspecified date. The patient underwent a CTA in the ER, on Feb2021, which showed no acute pulmonary embolism, or no ground glass infiltrates. The patient was admitted to the hospital on 21Feb2021 at 17:51 for management of worsening shortness of breath. Due to the patient's acute on chronic respiratory failure secondary to centrilobular emphysema and obesity, hypoventilation (as of an unspecified date in Feb2021) was further complicated by obstructive sleep apnea, thus, the patient was admitted to "MedSurg". The patient did not present with COVID-19 or COPD. The BMP was 226 at the time of admission. The patient was started on supplemental oxygen and additionally started on CPAP at night. She was seen by a pulmonologist who recommended Salmeterol Xinaf/ fluticasone (ADVAIR). Pulmonology also recommended to work-up any underlying unaddressed coronary artery disease contributing to the patient's shortness of breath. The patient underwent an echocardiogram on Feb2021 with regadenoson (LEXISCAN) for her shortness of breath which was within normal limits. As the patient additionally reported dysphagia at the time of admission, she was evaluated by a speech and swallow evaluation specialist as well as a gastroenterologist. A GI swallow series was recommended which the patient underwent on Feb2021 and was found to have no active signs of oropharyngeal or esophageal dysphagia. The patient additionally underwent a physical exam on 24Feb2021 at 08:00 with the following results. Vital signs: Temp: 98.2, Pulse: 69, Resp: 17, B/P (MAP): 98/62 (74), Pulse Ox: 96, O2 Delivery: Nasal cannula, O2 flow rate:2.00. HEENT: Pupils equal round reactive light accommodation, no lymphadenopathy noted, neck vens were apple. CVS: S1-S2 normal, no appreciable murmur rub or gallop noted. Respiratory: Good Inspiratory effort, good air entry bilaterally, no rhonchi, Rales or wheezes heard. Gl: Abdomen soft, nontender nondistended, bowel sounds heard, no organomegaly detected. Extremities: Bilateral lower extremities Shaw no edema, bilateral dorsalis pedis 2+, skin appeared intact. Neurological: Patient alert and oriented x3, strength 5x5 in all 4 extremities, no signs of focal neurological deficits. Skin: No clear breakdown or rashes noted. The patient was being discharged home on 24Feb2021 at 08:04 with a CPAP machine. The patient was prescribed Cefuroxime axetil (CEFTIN) 250mg Tablet orally twice a day; Salmeterol Xinaf/ fluticasone (ADVAIR) 250-50 diskus 1 puff twice a day for progressive shortness of breath and hypoventilation. The patient had been advised to follow-up with a pulmonologist for an outpatient pulmonary function test. The clinical outcome of progressive shortness of breath, hypoventilation, inability to eat, dysphagia, severe asthenia and mild upper abdominal pain was unknown. The reporting physician considered that BNT162B2 had no causal effect on the events reported. Information on the lot/batch number has been requested.; Sender's Comments: In agreement with the HCP reporter, the reported events do not appear to be related to the subject vaccine. The events likely represent intercurrent medical conditions, possibly associated with the patient's history of emphysema. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
83 2021-03-25 slurring Family members report the individual felt confused and presented with slurred speech. They took the ... Read more
Family members report the individual felt confused and presented with slurred speech. They took the individual to a local emergency room where it was determined their blood pressure was significantly elevated. The individual has since been transferred to a different hospital.
83 2021-03-28 numbness, speech disorder Trouble speaking; legs are swollen and numb; legs are swollen and numb; This is a spontaneous report... Read more
Trouble speaking; legs are swollen and numb; legs are swollen and numb; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6202, via an unspecified route of administration, administered in left arm on 27Feb2021 18:00 as single dose for COVID-19 immunisation. Medical history included Parkinson's disease. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient experienced trouble speaking, and legs are swollen and numb on 01Mar2021. The patient was hospitalized due to the events. No treatment was received. The outcome of the events was not recovered.
83 2021-03-28 pain in extremity Starting approximately one week after the first dose of vaccine, my mother began suffering what she ... Read more
Starting approximately one week after the first dose of vaccine, my mother began suffering what she describes as "episodes" of chest pain, neck pain (front and back), pain going down her arms, pain up into her jaw that are very sudden onset and cause her to have to lay down and rest until the episode is over. Timing of these episodes are random, but seem to occur when she first gets up in the morning or after she takes a shower or has been active. They lasts between 3 and 7 minutes and then completely resolve. She has never had any similar symptoms. She reports that these episodes occur between 4-6 times during the course of 24 hours.
83 2021-03-28 tingling, pain in extremity LEFT ARM.NECK PAIN,BACK PAIN TINGLING
83 2021-03-29 weakness Weakness, coded in ED, sent to cath lab and then ICU
83 2021-03-30 weakness, tremor, nerve injury her nerves pounding all throughout her body/the nerves in her whole body were just aggravated; she w... Read more
her nerves pounding all throughout her body/the nerves in her whole body were just aggravated; she was a little shake and kind of weak; a headache; a stiff neck/Her neck felt stiff; Heart beating really fast/Her heart was pounding she could hear it in her ears; a blood pressure of 174/78/Her blood pressure was 174/78; she was a little shake and kind of weak; her head felt heavy; her whole body felt heavy; She had ringing in her ears; This is a spontaneous report from a contactable consumer (patient). An 83 years old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration on 02Mar2021 at age of 83 years old at single dose for covid-19 immunisation. Medical history included hip surgery a few months ago and she was still kind of stiff and sore. Concomitant medications included lisinopril at low dose 10 mg once daily taken for blood pressure abnormal about 10 years ago; clopidogrel bisulfate (PLAVIX) taken for transient ischaemic attack from 2012 (she believed it was a around that time); acetylsalicylic acid (ASPIRIN LOW) at low dose (she began taking this before the Lisinopril so it has been several years).The patient mentioned that she received her 1st dose of the vaccine on 02Mar2021 and everything was fine that day and the day after. At late in the day on 04Mar2021, she experienced a lot of problems which she mentioned was the worst experience in her life. She was 99% sure it was from the vaccine because she didn't experience anything like that before getting the vaccine. She mentioned that she experienced side effects all night like her heart beating really fast, a headache, a stiff neck, her nerves pounding all throughout her body, and a blood pressure of 174/78. She mentioned that it was the worst she's felt so far as compared to going to the ER, as she's experienced before. She did not go to the ER as she could not drive herself and she was living alone. She mentioned that she better the next day although it was not totally gone, she was a little shake and kind of weak. As of calling, she said that she was feeling okay and better than yesterday (07Mar2021) in which the effects were still present. She mentioned that it was horrible, very scary, she was very ill, very uncomfortable, really bad, and didn't want to go through that again. She didn't know if she would make it through the night. She was asking for what to do and asking if there needed to be an adjustment for her dose because she was a very small person. She didn't want to have the 2nd shot if she went through that again. It was the worst experience of her life. She was not sure what to do now about her second shot. She had the first shot 02Mar2021 and everything was fine, 03Mar2021 she was okay but on 04Mar2021 she had, by night time, she had a lot of scary things that had never happened to her before. Her heart was pounding she could hear it in her ears. Her head, her neck felt stiff and her head felt heavy, her whole body felt heavy and like the nerves in her whole body were just aggravated, it was hard to explain. She had ringing in her ears. Her blood pressure was 174/78 and she was just afraid to have the second shot, it was scary, it was really bad. She was wondering if the amount of the vaccine was too much for her. She confirmed it was the evening 04Mar2021 when all this began. She said all of this was pretty well recovered at this point. She said the day after that happened, she was shaky but today (08Mar2021) she was fine. She did not know what it would be medications they are looking for but she was on normal medicine for old people she guesses. This was so bad that she really was not going to take the second dose unless they can tell her if she should or that they should give her less or something like that. The outcome of events was recovered in Mar2021.
83 2021-03-31 pain in extremity, breast pain right arm was paralyzed; Caller experienced pain in her Rt arm on Friday, 12March2021 (injection was... Read more
right arm was paralyzed; Caller experienced pain in her Rt arm on Friday, 12March2021 (injection was in Lt arm); Caller also noticed pain in her breast/stinging pain in breast; aggrevated joint pain; She reports a diagnosis of Sjogren's; This is a spontaneous report from a contactable consumer (patient) via medical information team. An 83-year-old female patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206, Expiration date was not reported), via an unspecified route of administration in left arm on 11Mar2021 02:00 as single dose for covid-19 immunisation. Medical history included blood pressure high. There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect was none and additional vaccines administered on same date of the Pfizer Suspect reported as none. Patient received the Covid-19 vaccine. Patient had a really bad reaction to it and has to have an ultrasound. Patient has been having problems with joint pain. Patient has Sjogren's Disease on Mar2021. patient had the vaccine last Thursday. Patient woke at 2:00 in the morning and her right arm was paralyzed on 12Mar2021. Patient took Motrin for that. On Friday patient felt a stinging pain in her right breast and pain in her Rt arm (injection was in Lt arm) on 12Mar2021. patient felt better after taking Motrin. Her doctor advised her to have an ultrasound. She typically has joint pain. After having the vaccine it was aggravated on 12Mar2021. patient was unsure if patient should have the second dose. patient saw her doctor on Monday. She will need to have an ultrasound of her right breast. She takes two blood pressure medications and other medications. Therapeutic measures were taken as a result of right arm was paralyzed (monoparesis). The outcome of the event breast pain was recovered on 12Mar2021, right arm paresis was recovered on Mar2021 and unknown for other events.
83 2021-04-04 breast pain 3/30/21 AM = (Patient's notes) "Chest/breast PAIN throughout night and (previous) day. Pain continuo... Read more
3/30/21 AM = (Patient's notes) "Chest/breast PAIN throughout night and (previous) day. Pain continuously in back last two (2) days. Nauseated, weak bladder every hour or so. No appetite. 1st Covid shot 3-27.
83 2021-04-05 flushing PT RECEIVED 2ND DOSE OF COVID 19 VACCINE ON 4-1-21 , ON 4-2-21 PT WAS AT WORK FELT FLUSH AN... Read more
PT RECEIVED 2ND DOSE OF COVID 19 VACCINE ON 4-1-21 , ON 4-2-21 PT WAS AT WORK FELT FLUSH AND PAIN IN HER CHEST , WAS TAKEN TO HOSPITAL AND DIAGNOSED WITH EXTREME HIGH BLOOD PRESSURE ( POT PRESSURE NOMRALLY VERY CONTROLLED) 190/110. PT WAS KEPT OEVERNIGHT FOR OBSERVATION....... AND GIOVEN STRESS TEST 4-3-21 PT
83 2021-04-10 weakness, numbness and pain in extremities Patient developed generalized weakness with peripheral neuropathy four days after getting second inj... Read more
Patient developed generalized weakness with peripheral neuropathy four days after getting second injection. Patient had a right MCA distribution infarct on 3/24/21. Last injection was on 2/25/21. Patient died on 4/7/21 from consequences of infarct.
83 2021-04-11 pain in extremity This was my second shot. With the first I had sore arm for 2 days and joint point at left hip. A f... Read more
This was my second shot. With the first I had sore arm for 2 days and joint point at left hip. A few days prior to second shot i developed irritation on 2 days of left foot. Following second shot, I had sore arm for a day and a half, joint pain at left hip that extended all the way down my leg which caused difficulty walking. That pain lasted for 2 full days. The toe irritation developed into painful blisters and extended to 3 toes on my left foot. I am currently using Hydro cortisone cream on them.
83 2021-04-14 weakness N17.9 - Acute kidney failure, unspecified E83.42 - Hypomagnesemia N18.9 - Chronic kidney disease N17... Read more
N17.9 - Acute kidney failure, unspecified E83.42 - Hypomagnesemia N18.9 - Chronic kidney disease N17.9 - Acute kidney injury (CMS/HCC) R53.1 - Generalized weakness
83 2021-04-16 limb paralysis, slurring, severe one side paralysis Vertigo symptoms occurred 4/6/2021 less than 24 hours after vaccine was given. They persisted for 3... Read more
Vertigo symptoms occurred 4/6/2021 less than 24 hours after vaccine was given. They persisted for 3 days along with balance issues. on 4/9/2021 at 6:50 am stroke type symptoms occurred with slurred speech and paralysis on Let side arm and leg. Several stroke episodes, and blood pressure spiking occurred over a 3 hour period. Low grade fever presented on 4/11/2021. After much testing she was diagnosed with a series of TIA attacks found to be and averse effect from The COVID vaccine.
83 2021-04-19 pain in extremity Patient developed pain in her left calf 4 days after the 1st Pfizer COVID-19 vaccine. She was sent f... Read more
Patient developed pain in her left calf 4 days after the 1st Pfizer COVID-19 vaccine. She was sent for venous doppler and found with an extensive superficial venous thrombosis in the left great saphenous vein that was only cm from the deep system. The clot extended from the upper calf to the thigh. She was and is being treated for DVT as the clot was so extensive. She has no history of clots. She does have varicose veins and has not been as active as usual. She is currently still in treatment .
83 2021-04-22 feeling of body temperature change, weakness, tremor, hot flush, feeling hot, burning sensation 5 minutes post vaccine, started feeling warm burning sensation all over, stayed on site for 60 minut... Read more
5 minutes post vaccine, started feeling warm burning sensation all over, stayed on site for 60 minutes. Was briefly shaky and weak, recovered enough to drive home after waiting. Nausea started later that evening and has been on and off since date of the vaccine. Patient describes warm burning sensation from waist up nightly since vaccine, also has hot/cold flashes followed by fatigue next day. Reports headache for several days following vaccine. Patient reports similar burning sensation has happened with other medications in the past including the 2019-2020 flu shot and antibiotics (unsure what types). Patient reports that the flu shot reaction was possibly a neomycin hypersensitivity, did not know specific type of flu shot.
83 2021-04-22 pain in extremity, cold extremities Upper arms felt cold. Complained of lower leg pain which subsided with walking. BP 146/65 (pulse 59)... Read more
Upper arms felt cold. Complained of lower leg pain which subsided with walking. BP 146/65 (pulse 59). 100% O2 sat.
83 2021-04-23 pain in extremity Hives over most of my body both itchy & painful in places. Lasted about 4 days
83 2021-04-24 weakness, tremor Severe Sore Throat; Stiff neck; Shortness of breath; Back ache; every bone and every part of her bod... Read more
Severe Sore Throat; Stiff neck; Shortness of breath; Back ache; every bone and every part of her body hurt; every bone and every part of her body hurt; pain under her ribs; weak and shaky; weak and shaky; biceps ached; Fatigue; tremendous headache; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 28Mar2021 14:00 (Batch/Lot number was not reported: did not get a card that lists NDC, Lot, Expiration) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. It was also reported that no additional vaccines were administered on the same date. The patient did not require visit to Emergency Room and stated that she was desperate and would've gone but she didn't have a ride and added she is worried about the second. Also, the patient did not required visit to the physician's office. No prior vaccinations (within 4 weeks). No family medical history. The patient reported that she received the first dose of the vaccine and 5 days later she got a terrible reaction. She did not expect it. She had a terrible reaction and thought she was going to die. She stated she wanted to report this because the TV says you should expect some kind of reaction after the second dose but does not say after the first and she said that Pfizer needs to know about this reaction. She stated she heard the second dose is worse. The patient asked if she has to get her second dose and if she needs to report this anywhere else? The patient added "what should I do about side effects?" It was reported that the patient (reported as is almost 84) had the first shot on Sunday 28MAR2021 and everything was fine by Friday she was in terrible trouble really really bad. States she has never heard of this, they say the first is easy and everything was terrible. States every bone and every part of her body hurt on 02Apr2021. She states after 24 hours (03Apr2021) it did go away. The patient asks does this happen to other people? It was stated that her symptoms came on suddenly and she had a severe sore throat, stiff neck, back ache, pain under her ribs, very very weak and shaky, shortness of breath, biceps ached, fatigue, and a tremendous headache. It was stated that started on Friday 02Apr2021 12:00 like a hurricane and after 24 hours they subsided on Saturday 03Apr2021. The patient added that she doesn't remember getting a card and didn't know that she should have a card until she saw something about it on TV, and thought well she didn't get a card. The patient also asked what does she do about that? The patient states she takes medication but not that affects this. The outcome of the events recovered on 03Apr2021. Additional information has been requested
83 2021-04-24 discomfort HTN exacerbation, discomforts within 2-3 days that lasted over a month and required multiple office ... Read more
HTN exacerbation, discomforts within 2-3 days that lasted over a month and required multiple office visits and medication increases to control HTN.
83 2021-04-24 numbness Bones aching, - elbows, arms and hands numb - nausea, diarrhea, no appetite - sleeping all the time ... Read more
Bones aching, - elbows, arms and hands numb - nausea, diarrhea, no appetite - sleeping all the time - depressed , excessive sweating on the left side of face and neck - excessive phlegm production as well as left eye buringin
83 2021-04-24 pain in extremity I had a terrible pain in my leg between the knee and the groin; This is a spontaneous report from a ... Read more
I had a terrible pain in my leg between the knee and the groin; This is a spontaneous report from a contactable consumer or other non hcp. A 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9269), first dose via an unspecified route of administration, administered in left arm on 21Feb2021 as SINGLE DOSE for covid-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date approximately 14 hours later after her vaccination, early morning, she had a terrible pain in leg between the knee and the groin and it lasted for couple of minutes but it was very severe and she didn't know whether she should report this or not." She stated "my height is 5 feet 6 inch, I think I am shrunk and my weight is 210, more or less". Outcome of the event was unknown.
83 2021-04-24 tenderness, pain in extremity This is a spontaneous report from a Contactable consumer (patient). An 83-year-old female patient re... Read more
This is a spontaneous report from a Contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), dose 1 via an unspecified route of administration on 05Feb2021 as a single dose for COVID-19 immunization. There was none medical history. Concomitant medication included atenolol taken for an unspecified indication, start and stop date were not reported. Her leg was swollen and there was edema and there was a lump on the side and it was pink or getting red and she was on medicine (Clarification Unknown) for 7 days, twice a day and the leg is still (incomplete sentence), the edema has gone down some. The leg was still pink and it is tender to touch and if she stand on her leg for too long or walking around too much it hurts. She got pain. She was also sleeping whereby she was watching television and all of sudden she was sound sleep and she wake up over an hour or two after that and then she awake for a while but she have no trouble sleeping at night again. She had chest pain and it's not angina because that she did have (Further clarification was unknown if consumer had angina in past hence not captured on tab) but it's a sharp pain and it does not want her taking Nitroglycerin because it went away and it last for maybe (incomplete sentence) it just like a stabbed wound. She was dizzy. That's still, it's not like what it was but it is getting less but she was still dizzy. She cannot walk a straight line. She lived in an apartment house and she had to walk down the hall to go down the stair but she sometime had to stop because she was dizzy. she kind of lean against the wall for few seconds and then she continued on. Concern was not the word for it. It made her very nervous and the circulation was very poor in both feet now and one leg, the right leg that has the pink and still the tenderness in that leg. The foot turns very dark pink and the big toe that she had turned dark purple. She wrote everything down and she will say this at the time after the injection she did not have any problem until about four days later but she did have problem with doing my cross- word puzzles and doing her puzzles. She could not do any of her puzzles, nothing was computing in her brain (Clarification unknown) but that's coming back slowly, so is that to be expected. Start date of event: Consumer stated "It was 4 days after the 5th, about 09Feb2021. She went there and saw a doctor an MD of course and she went there on 12th so it was a week later. She went because the pain was terrible. The outcome of events Leg is still pink and it is tender to touch; If I stand on my leg for too long or walking around too much it hurts, I got pain; Dizzy; is not recovered, all of sudden she was sound sleep; Cannot walk a straight line; Nervous; Circulation is very poor in both feet now; Foot turns very dark pink and the big toe that I have turned dark purple; Nothing was computing in my brain; pain was terrible was unknown, outcome of the other events was recovering. No follow-up attempts are possible. No further information is expected.
83 2021-04-26 unresponsive to stimuli Patient found unresponsive in home, attempted CPR and provided epi x 3 in transport to ED. ACLS con... Read more
Patient found unresponsive in home, attempted CPR and provided epi x 3 in transport to ED. ACLS continued at the ER, but RSC unable to be achieved. Death pronounced at 0925 AM
83 2021-04-30 inability to speak, pain in extremity lactic acid was high; dementia had suddenly progressed; spot where her lung was starting to collapse... Read more
lactic acid was high; dementia had suddenly progressed; spot where her lung was starting to collapse; potassium, Vitamin D and Vitamin B12 were low; potassium, Vitamin D and Vitamin B12 were low; potassium, Vitamin D and Vitamin B12 were low; stopped talking; Cellulitis in her arm/ cellulitis was further down her arm, around her wrist hand area (Her wrist was huge, hot, red, and her hand was swollen); it burned when she peed; blood in her urine; wanted to sleep/getting worse with sleeping; was shutting down; she was dehydrated because her urine was dark; urine was dark; began just feeling bad/having like a terrible time/having a hard time/really not feeling good; more confused; lethargic; had trouble her getting up/was having to do everything for her, feed her, bathe her; couldn't walk; lost her appetite; arm was sore; This is a spontaneous report from a contactable consumer (patient's daughter). An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration, administered in the left arm, on 24Feb2021, as single dose, for COVID-19 immunisation. Medical history included mild asthma, dementia (moments like putting things in the wrong place and being forgetful) and was confused. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) received at age 83 years, on 03Feb2021, for COVID-19 immunisation. On 24Feb2021, after the second vaccinations, the patient's arm was sore. On 06Mar2021, the patient began just feeling bad, was having like a terrible time, having a hard time, was really not feeling good; was more confused; lethargic; had trouble getting her up, was having to do everything for her, feed her, bathe her; couldn't walk and lost her appetite. On 09Mar2021, the patient was shutting down. On the same day at 18:30, the patient had gone in the bathroom and said it burned when she peed. So, the patient was taken to urgent care so it would not get out of hand. At the urgent care, they said she has a UTI, there was blood in her urine so they gave her Cipro but they cultured her urine and it grew no bacteria but there was still blood in her urine and she was getting worse with sleeping and she didn't even get up to eat. The patient was also dehydrated and her urine was dark. The events dehydrated, urine was dark, it burned when she peed, blood in her urine required emergency visit on 16Mar2021. The reporter thought the patient was going to die. On 16Mar2021, in the ER, they did blood work (unknown result), chest xray which showed she had a spot where her lung was starting to collapse (they said it was a tiny place, from not getting up and moving around, they said it would correct itself) and the patient's potassium, Vitamin D and Vitamin B12 were low. They did a CT scan of the head and chest to look for stroke or seizure and there was nothing. They blamed it on her dementia that had suddenly progressed. The patient was hospitalized from 16Mar2021 to 18Mar2021. On 12Mar2021, the patient experienced cellulitis in her arm. The reporter clarified that the cellulitis was further down her arm, around her wrist hand area. Her wrist was huge, hot, red, and her hand was swollen. On 24Mar2021, the patient followed up with the family doctor because the hospital wanted her to follow up with a GYN because they didn't feel it was urinary at all. When the reporter took the patient in to see the doctor, she couldn't walk in, she had to roll her in a wheelchair, she had stopped talking again. On 26Mar2021, the doctor sent the patient to the emergency room (unspecified reason) and they kept her. They said her said lactic acid was high. She was admitted on 26Mar2021 and discharged on 29Mar2021. On 29Mar2021, the patient's potassium was 3.3 and her lactic acid level was back to 2. The patient was recovering from lactic acid was high; potassium, Vitamin D and Vitamin B12 were low; began just feeling bad/having like a terrible time/having a hard time/really not feeling good; more confused; lethargic; had trouble her getting up/was having to do everything for her, feed her, bathe her; couldn't walk; lost her appetite; was shutting down; stopped talking. The patient recovered from cellulitis in her arm/ cellulitis was further down her arm, around her wrist hand area (Her wrist was huge, hot, red, and her hand was swollen) in Mar2021; and arm was sore on 29Mar2021. The outcome of events spot where her lung was starting to collapse, dementia had suddenly progressed; she was dehydrated because her urine was dark; it burned when she peed; blood in her urine; and wanted to sleep/getting worse with sleeping was unknown.
83 2021-04-30 pain in extremity muscle pains and soreness that started with her left arm and kind of settled on her left shoulder bl... Read more
muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade.; muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade.; muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade.; This is a spontaneous report from a contactable consumer(patient). An 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number Unknown), first dose via an unspecified route of administration, administered in left arm on 31Mar2021 as single dose for covid-19 immunization. Patient was 83 years old at the time of vaccination. Patient's medical history and concomitant medications were not reported. On an unspecified date reporter mentioned that muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade. She puts rubbing alcohol, a Salonpas patch, and extra stregnth Tylenol for it. She is not associating it with the vaccine, but would like to know if she can receive her 2nd dose on her right arm. She is scheduled for it on Wednesday, 21Apr2021. Therapeutic measures were taken as a result of events. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
83 2021-05-01 pain in extremity Moderate sore arm on first day and night, slight fatigue on second day, On third day (Wednesday) de... Read more
Moderate sore arm on first day and night, slight fatigue on second day, On third day (Wednesday) depression, sadness, lack of interet in normal activities, difficulty concentrating as normal. Better on Thrusday.
83 2021-05-02 weakness PATIENT DEVELOPED FEVER, WEAKNESS, DYSPEA, NAUSEA, VOMITING, DIARRHEA, WITH AN O2 SAT OF 80% ON ROOM... Read more
PATIENT DEVELOPED FEVER, WEAKNESS, DYSPEA, NAUSEA, VOMITING, DIARRHEA, WITH AN O2 SAT OF 80% ON ROOM AIR AND RESPIRATORY OF RATE OF 40. PATIENT TESTED POSITIVE FOR COVID 19 AND WAS HOSPITALIZED, LATER PLACED IN ICU
83 2021-05-03 pain in extremity 7 day post shot 2: sore feet - could not stand up 9 days post shot 2: vomiting, lethargy, severe c... Read more
7 day post shot 2: sore feet - could not stand up 9 days post shot 2: vomiting, lethargy, severe chest pains, lymphopenia, low magnesium, low glucose, mildly elevated troponin
83 2021-05-03 seizure She received her second COVID shot at the end of March first week of April. My mother had a stroke, ... Read more
She received her second COVID shot at the end of March first week of April. My mother had a stroke, several seizure and her lungs were filled with blood clots. She had to have a procedure to remove the largest one next to her heart. My mother has always been healthy and has never had any of the following issues in her life. She gets regular checkup and I spoke with her on April 19, 2021 at 12:00pm Central time and she was fine but at 1:20pm my brother who is staying at her house said she was having a seizure. I talk to my mother at least four times a day and she has never in 83yrs experienced anything like this. She doesn?t remember right now where her shot was administered but my brother took her but he is mad at me because I have full power of attorney and he is not happy. Therefore, he will not give me the information that is needEd to give to your office. My mother was admitted to the ICU. She is now at their rehab center in a hospital. Once my mother is released from the hospital she is moving with me out of state. This is and unexpected expense that I will need assistance with but I don?t mind because it is my mother and now someone has to be with her 24/7.
83 2021-05-04 weakness Presented to ED w/hx of harsh, nonproductive cough (4/7) & subsequent positive COVID-19 test (4/13) ... Read more
Presented to ED w/hx of harsh, nonproductive cough (4/7) & subsequent positive COVID-19 test (4/13) despite receiving Pfizer vaccines (1/21 & 2/16). Continued to have worsening cough w/occasional SOB, generalized weakness affecting daily activities and poor oral intake. Found to be febrile, hypotensive w/increased confusion. Imaging revealed opacity of R middle lobe & bilateral lower lobe consolidation concerning for pneumonia. Was admitted for additional management of sepsis & acute hypoxic resp failure secondary to COVID-19 on 4/22. Treated w/dexamethasone & started on ceftriaxone for asymptomatic Ecoli UTI. Pt ultimately discharged (4/29) w/extended antibiotic course for MSSA bacteremia w/ID follow-up on 5/24
83 2021-05-04 hot flush dizzy/dizziness; hot flashes; This is spontaneous report from a contactable other healthcare profess... Read more
dizzy/dizziness; hot flashes; This is spontaneous report from a contactable other healthcare professional (the patient). An 83-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on 22Mar2021 (Lot Number: ER6955), dose 2 on 14Apr2021 (Lot Number: ER8735) (Time the Vaccination Was Given as "1000", it did not specify if it refers to the first/second dose), both via an unspecified route of administration in the right upper arm at age of 83-year-old at single dose for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Medical history included vertigo that happened 6-7 years ago and she was hospitalized for this. No family medical history relevant to AE. The patient's concomitant medications were not reported. The patient experienced the dizziness and hot flashes after the first dose of the vaccine (2021), the caller did not know dates of the dizziness and hot flashes she experienced after the first dose of the vaccine. The symptoms then weren't as bad as the ones she was having currently after the second dose of the vaccine. The caller stated that she had been dizzy, it was almost like vertigo that she had once before, she had been dizzy since Friday 16Apr2021 and was very dizzy on Saturday 17Apr2021 (after the second dose). She had also been having hot flashes. She has Meclizine and had taken those a couple of times. The patient had the same symptoms after the first dose of her vaccine but they were not as severe. Caller stated she did not know if her symptoms were caused by the vaccine. She thought they might be since they started after the vaccine but is not certain. No Emergency Room or Physician Office visit. The outcome of the events was recovering. The events were not serious. No follow-up attempts are needed. No further information is expected.
83 2021-05-06 trigeminal neuralgia This 83 year old female received the Covid shot on 1/19 and went to the ED on 2/3/21 and was ... Read more
This 83 year old female received the Covid shot on 1/19 and went to the ED on 2/3/21 and was admitted on 2/3/21 with the diagnoses listed below. I63.9 - Cerebral infarction, unspecified G50.0 - Trigeminal neuralgia J12.82 - Pneumonia due to Coronavirus disease 2019
83 2021-05-10 face paralysis I60.9 - Subarachnoid hemorrhage (CMS/HCC) J18.9 - Pneumonia I63.9 - Acute CVA (cerebrovascular accid... Read more
I60.9 - Subarachnoid hemorrhage (CMS/HCC) J18.9 - Pneumonia I63.9 - Acute CVA (cerebrovascular accident) (CMS/HCC) N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness
83 2021-05-10 feeling hot Pain; soreness in that left shoulder; swelling; Area was warm to touch; could not sleep last night; ... Read more
Pain; soreness in that left shoulder; swelling; Area was warm to touch; could not sleep last night; had light mild pain in left shoulder at the site of injection; This is a spontaneous report received from a contactable consumer (husband). This consumer reported for a 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. On an unknown date Medical history included cancer of thyroid, mitral valve replacement and use of a pacemaker. Concomitant medications were not reported. On Apr2021 the patient experienced had light mild pain in left shoulder at the site of and could not sleep last night; On 20Apr2021 the patient experienced pain and soreness in that left shoulder, swelling, area was warm to touch, could not sleep last night. The report received as, the reporter's wife got the first dose of the Pfizer Covid 19 vaccine on 07Apr2021 and had light mild pain in left shoulder at the site of injection for 2 days. Then 12 days later, on either 20Apr2021 or 21Apr2021, she developed pain and soreness in that left shoulder again, down to her elbow, with swelling and area was warm to touch. She did not have a fever. It bothers her and she could not sleep last night. She is scheduled for the second dose on 28Apr2021. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
83 2021-05-11 weakness ED to Hosp-Admission Discharged 3/6/2021 - 3/7/2021 (29 hours) Hospital Last attending ? Treatment... Read more
ED to Hosp-Admission Discharged 3/6/2021 - 3/7/2021 (29 hours) Hospital Last attending ? Treatment team COVID-19 virus infection Principal problem Hospital Course HPI: Patient is an 83 y.o. female in the emergency room with a headache that is been persistent for about a week. She is also having some increasing fatigue and weakness. Evaluation emergency room revealed she is positive for COVID-19. Chest x-ray showed no evidence of pneumonia. The patient did have her first COVID-19 vaccine approximately 3 weeks ago. She was due for her second dose of the vaccine this coming Monday. She denies any severe fevers at home. No shortness of breath, no chest pain. She was brought in for observation and started on dexamethasone. Hospital Course: Remained under observation and did not require any supplemental oxygen. He tolerated her diet and did not feel weak or fatigued. She denied any chest discomfort. I recommended that she postpone getting her second Covid vaccine until she is entirely cleared of her Covid infection. Should follow-up with her primary care office to assess breathing and when she is cleared for her second vaccination. Patient also have her family physician or gynecologist reevaluate her pessary which may have been dislodged slightly when she fell in recent weeks. She had noticed some blood tinge urine but generally no dysuria or major hematuria since that time. She left in satisfactory condition on the evening of 3/7/2021 with these instructions. She may use acetaminophen for the headaches which have disappeared over the course of this day.
83 2021-05-13 face paralysis R29.810 - Facial weakness NEUROLOGIC PROBLEM
83 2021-05-16 weakness, pain in extremity Pain in right thigh; Pain moved down leg into knee and calf; Pain moved to right foot, felt like sto... Read more
Pain in right thigh; Pain moved down leg into knee and calf; Pain moved to right foot, felt like stone bruise when walking; Pain moved to left foot and leg; gums bleeding; very tired, no energy. Had 2 steroid shots; went to Podiatrist for Plantar Fascia; He detected possible blood clot.
83 2021-05-17 weakness Is pregnant: Yes; severely dizzy; weak unable to stand; vomited; severe chills; sweats then a temp o... Read more
Is pregnant: Yes; severely dizzy; weak unable to stand; vomited; severe chills; sweats then a temp of 99.3; sweats then a temp of 99.3; I had to crawl in order to move from place to place; This is a spontaneous reporter from a contactable consumer (patient). This 83-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) in right arm via unknown route of administration on 17Feb2021 at 10:30 am as single dose for COVID-19 immunization. The patient was pregnant at the time of vaccination. Medical history of patient was reported as osteoarthritis, rheumatoid arthritis, penicillin allergy, allergies from components of Epinephrine Solution and AVALOX. Concomitant medications included ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin B1 nos, vitamin B12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER), ascorbic acid, retinol, tocopherol (OCCUVITE), cholecalciferol (D3) and aspirin. No covid prior vaccination. No covid tested post vaccination. No vaccine in four weeks. On 18Feb2021 at 07:30 AM, 20 hours after the injection the patient experienced severely dizzy and weak unable to stand. She had to crawl in order to move from place to place. This lasted about 15-20 minutes. She vomited and developed severe chills and sweats then a temperature of 99.3. No treatment was given. The outcome of events was recovered in 2021. No follow-up attempts are possible. No further information is expected.
83 2021-05-21 facial paralysis STROKE; Facial droop; This is a spontaneous report from a contactable physician. An 83-year-old fem... Read more
STROKE; Facial droop; This is a spontaneous report from a contactable physician. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular on 02Mar2021 (Batch/Lot Number: EM9809) as 2ND DOSE, SINGLE for covid-19 immunisation; and carbidopa, levodopa (DUOPA), via percutaneous j-tube from 2018 (Batch/Lot number was not reported) and ongoing, at unspecified dose for advanced parkinson's disease. Medical history included maternal history of strokes, and paternal history of strokes, both on unspecified dates. Concomitant medication included carbidopa, levodopa taken for an unspecified indication, start and stop date were not reported. Historical vaccination included first dose of BNT162B2 on 20Jan2021, intramuscular, with lot number: EL19261 for covid-19 immunization. The patient experienced stroke on Apr2021 with outcome of unknown, and facial droop on Apr2021 with outcome of recovering. Details were reported as follows: The patient felt like she experienced a mini stroke in Apr 2021. She had her Peg and J tube replaced on 16Apr2021 because they came completely out. Her husband was not sure if the pump was working states he could not saw the medication. Her husband had the pump disconnected from her. NCM advised her husband to run the pump over paper towels. Her husband did as instructed and could then saw the medication. He then connected patient to the pump and the pump ran without any error codes or alarms. Her husband wanted to make sure patient did not need a new pump since she got new tubing. NCM assured that the current pump seemed to be working fine with the new tubing. She left sided mouth droop in Apr 2021. She was taken to the local hospital via emergency medical services (EMS). She was then transferred to Hospital in for evaluation. She was in the ER awaiting a bed for 20 hours. The primary reporter did not know if any tests or medicine obtained as he did not receive any paperwork. After 20 hours, she was discharged from the ER home. She had a brain waves test a few days later to confirm if stroke had occurred. The primary reporter stated he did not feel the COVID vaccine was related to he events of Mouth droop and possible stroke. The patient underwent lab tests and procedures which included brain waves test: results pending on 21Apr2021. The action taken in response to the event(s) for bnt162b2 was not applicable, and for carbidopa, levodopa was dose not changed.; Sender's Comments: Based on information provided, considering the age and medical history of the patient, the event stroke is assessed as unrelated to BNT162B2. The event "facial drop" is assessed as symptom of the event stroke, hence not related to BNT162B2 either. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
83 2021-05-28 weakness I woke up dizzy; I still don't feel good; probably little weak; This is a spontaneous report was rec... Read more
I woke up dizzy; I still don't feel good; probably little weak; This is a spontaneous report was received from a contactable consumer or other non hcp. An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3249; Expiration Date: 31May2021), via an unspecified route of administration, administered in left arm on 19Jan2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history was not reported. The patient was taking unspecified concomitant medications. She was fine for the first few days on the 5th day, i.e., on 24Jan2021, she woke up dizzy and she still do not feel very good and still do not feel good. Well patient just don't feel good, nothing can pinpoint it and probably little weak, she did not know and have not been doing much, she don't feel good. Patient do take medications, going to have to go get the list and took Tylenol couple of times as treatment. Patient reported that they scheduled the second one and it is 4 weeks rather than the 3 weeks. The patient was not recovered from "I still don't feel good" and outcome of the other events was unknown. Follow-up attempts are completed. No further information is expected.
83 2021-06-03 facial paralysis Cranial Nerve VII Palsy; Double Vision requiring an eye patch on one eye so that I can see single ob... Read more
Cranial Nerve VII Palsy; Double Vision requiring an eye patch on one eye so that I can see single objects; Medial drifting of left eye. Inability of left eye to move laterally past midline.; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: ER8733), at the age of 83 years old, in right arm on 30Apr2021 at single dose for covid-19 immunisation (The patient also received the second dose of BNT162B2 (lot number: EW0169), at the age of 83 years old, on 30Apr2021 at single dose for covid-19 immunisation, pending clarification). The patient was not diagnosed with covid-19 prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) and omeprazole. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced cranial nerve VII palsy on Apr2021. On Apr2021, double vision requiring an eye patch on one eye so that she can see single objects, medial drifting of left eye and inability of left eye to move laterally past midline. The patient was hospitalized for the events for 4 days. The patient was unknown if she was tested for covid-19 since the vaccination. Therapeutic measures were taken as a result of events and included treatment with prednisone. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
83 2021-06-07 weakness downward spiral after 2nd vaccine; high blood pressure; extreme back pain; swelled feet; pain was ar... Read more
downward spiral after 2nd vaccine; high blood pressure; extreme back pain; swelled feet; pain was arthritis; vomiting a lot; very weak; sodium was low; arm is blue; vision is decreasing; This is a spontaneous report from a contactable consumer (Patient's daughter) communicated to a Pfizer Colleague. An 83-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EN6206) as 2ND DOSE, SINGLE, vaccinated at the age of 83 years old for covid-19 immunisation. Patient received the first dose of bnt162b2 (lot number: EN6201, at the age of 83 years old) on 17Feb2021. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had no previous health issues, then from 12Mar2021 downward spiral after 2nd vaccine. Within days of shot, on 12Mar2021 had high blood pressure(178/86) extreme back pain, swelled feet. Dr then said pain was arthritis and presribed blood pressure med for high bp. Pt was getting worse and in a couple of weeks ago she was vomiting a lot and was very week. Went to ER and was kept overnight. Was told sodium was low and she was sent home. Now her arm is blue and her vision is decreasing. Reporter reported her mother never had any health issues prior to getting vaccine. Events feeling abnormal, hypertension, back pain, swelled feet, pain was arthritis, vomiting, very weak and sodium was low resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care and hospitalized. Outcome of events was not recovered.
83 2021-06-08 weakness Patient admit to Hospital 5/23/21 for cough, weakness and SOB x 4 days. Pt had completed COVID19 v... Read more
Patient admit to Hospital 5/23/21 for cough, weakness and SOB x 4 days. Pt had completed COVID19 vaccines earlier in the year and attended a family wedding 5/14/21 and developed respiratory symptoms within 3 to 4 days thereafter. Several family members now COVID19 positive, including patient (positive test approximately 5/18). Patient with history of COPD (on 2L 02 at home), and decision made to admit patient for close monitoring. Vaccination History: 1/23/21 Pfizer EL3249 2/13/21 Pfizer EL9264 Hospital Course: Patient admitted to COVID19 general unit, and started on IV dexamethasone (6mg IV daily) and remdesivir (200mg IV x 1, then 100mg IV daily). COVID19 test 5/24 was positive, and was to be sent to ODH for genotyping. Patient required 02 at 4L NC initially, then was able to tolerate 2L NC thereafter. Patient improved with less body aches and no SOB by 5/25. Patient continued to improve and was discharged home with HHC 5/28 with remdesivir course complete and home going med of dexamethasone 6mg daily x 5 more days.
83 2021-06-09 inability to speak Received 2nd shot 4/16/21 SARS-COV-2 (COVID-19/PFIZER) mRNA BNT162B2 (PF) IM (LNP-S) EUA, beginning ... Read more
Received 2nd shot 4/16/21 SARS-COV-2 (COVID-19/PFIZER) mRNA BNT162B2 (PF) IM (LNP-S) EUA, beginning of May patient started to become OCD with her purse and wallet, on 5/12 she put ravioli that was to be boiled into the microwave and started a fire. After she did so, she realized it was wrong and said "how stupid" "why did I do that". I proceeded to make dinner for her and her meals for the next day, I advised her that I was going to take her to the hospital on Friday 5/14 for a Mental Health check as she began to decline. She returned home from but had her stay with me didn't trust her to stay alone. I followed up with her CP, Neurologist and Cardiologist, during her visits she struggled with words but was aware something was wrong as she stated "i just want the old me back". From 5/15 thru 6/1 her mental health only worsened, she had no cognitive functions (phone, tv, computer) unable to eat on her own and shower. We placed her in a Memory Care Facility on 6/2, she fell the next day and was hospitalized with a broken hip, she is now in rehab. The current reports are she is not eating well, put on a puree diet since she is having swallowing issues, cannot talk and attention span is minimal, The PET Scan determined Alzheimer's with Picks Disease. She showed absolutely no signs of decline prior to the 2nd vaccine.
83 2021-06-09 pain in extremity Right leg bothering her; mind went blank and she was unable to think of her email address to provide... Read more
Right leg bothering her; mind went blank and she was unable to think of her email address to provide; Arm soreness and arm soreness was getting worse/arm was sore; This is a spontaneous report from a contactable consumer (patient). An 83-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 21Feb2021 as single dose for covid-19 immunisation (at the age of 83 years). The patient medical history and concomitant medications were not reported. The patient experienced right leg bothering her and mind went blank and she was unable to think of her email address to provide on an unspecified date, arm soreness and arm soreness was getting worse/arm was sore on 21Feb2021. The patient received her first dose of the Covid-19 vaccine on 21Feb2021, and her arm was sore on the 21Feb2021 (that night) and on the 22Feb2021 (next day) but went away. The pain came back two and a half weeks later, and her 2nd shot was scheduled for this 13Mar2021 (Saturday). It seemed like it was okay after the first two days, but now it was back. Her arm had been sore, all week; on 10Mar2021 (today) it was really sore. She also mentioned her right leg was bothering her (start date: unspecified), but she didn't think that's related to the vaccine. She did not know if it was like just really dull before and she did not really notice it. It seemed like it was okay, and all of a sudden, each day she felt a little sore and today was really sore. She confirmed after the vaccine she had arm soreness and the arm soreness was getting worse. On 13Mar2021 (Saturday), it would be 3 weeks since she received the first dose. She took ADVIL as treat-ment, and but it didn't seem to help (Usually, ADVIL helps her). She did have TYLENOL and wanted to know if you can alternate TYLENOL and ADVIL. While attempting to provide email she commented her mind went blank and she was unable to think of her email address to provide (start date: unspecified). In concern to height, she thought she had shrunk. She wanted to know if it was normal for the pain to come back after about 2 and a half, almost 3 weeks and since this arm was sore, will she have to get it in her other arm. Therapeutic measures were taken as a result of arm soreness and arm soreness was getting worse/arm was sore. The outcome for arm soreness and arm soreness was getting worse/arm was sore was not recovered, and for another event was unknown. No follow-up attempts are possible; information about lot/batch cannot be obtained.
83 2021-06-13 brain damage Patient presented to emergency department on 6/4/21 with altered mental status. During workup patien... Read more
Patient presented to emergency department on 6/4/21 with altered mental status. During workup patient was found to be COVID-19 positive. Patient had fever at time of admission which was believed to be caused by COVID-19 infection. She was admitted for lacunar infarct and acute encephalopathy. She was started on dexamethasone for COVID-19 management, but was stopped as there was no major change in disposition with treatment. During the course of the hospital stay, she was deemed asymptomatic for COVID-19 and her symptoms were more likely to be attributed to other causes.
83 2021-06-24 muscle spasms, pain in extremity Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second v... Read more
Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine; This is a spontaneous report from contactable consumer 83-year-old female (patient) reported for herself. An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection), via an unspecified route of administration, administered in arm left on an unspecified date as 2nd dose, single for COVID-19 immunization (at the age of 83-year-old). Medical history included ongoing gout, ongoing High blood pressure and ongoing pain. Concomitant medications included allopurinol taken for gout, aspirin (ACETYLSALICYLIC ACID), losartan taken for high blood pressure, felodipine for high blood pressure, diclofenac sodium taken for pain. The patient administered BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown), first dose via an unspecified route of administration, administered in arm left on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient did not receive any other vaccine prior to COVID-19 Vaccine. On an unspecified date, the patient experienced Muscle spasms: associated with pain in leg both legs, can't walk, and legs puffed up, after second vaccine. The patient stated she wanted to go to the Urgent Care, but it was crowded. She feels stressed out, because she was waiting for her daughter to take her to the hospital. She cannot figure out why she hurts so bad. The patient stated she was a lady who can get around and take care of herself and stated several examples of how she was independent, and she exercises. The patient stated her daughter was going to take her to the hospital, because she feels there was something serious going on that day. Outcome of the events were reported as unknown. Information about lot/batch number is requested.
83 2021-06-24 tremor Site: Pain at Injection Site-Medium, Additional Details: whole body tremor, lower back pain. Blood O... Read more
Site: Pain at Injection Site-Medium, Additional Details: whole body tremor, lower back pain. Blood O2 was 99%, HR 76bpm. Unsure of the reaction, benadryl and epipen were given. Pt went home walking after 20 mins of the event. Paramedics did not arive on time and were cancelled after pt went home. Pt was advised to see PCP
83 2021-06-27 feeling hot It was at 1pm the appointment. My arm didn't hurt but I felt a little exhausted. I went to my daught... Read more
It was at 1pm the appointment. My arm didn't hurt but I felt a little exhausted. I went to my daughter's and I had no reaction. I came home and slept fine. After 7 days, I got hot spells and I keep taking my temperature. Sometimes it varies from 98.7-97.9. I started getting headaches and a lump in my neck after 3 weeks. I saw an ENT and he said these symptoms would go away. I was coughing and I asked my doctor to get a CAT scan. I had inflammation on my chest. It was last week that my PCP told me to see a pulmonary doctor. The disk that she had given him was not clear and that he couldn't determine anything. I have told my doctor about the weird headaches and acid reflux that I have been getting.
83 2021-06-29 weakness Chills, fever, weakness, exhaustion, nausea, abdominal distress with diarrhea, sore belly, insomnia,... Read more
Chills, fever, weakness, exhaustion, nausea, abdominal distress with diarrhea, sore belly, insomnia, back muscle pain, unusual dreams, hallucinations. Symptoms on and off to varying degrees for a month, especially muscle pain. Fatigue was constant.
83 2021-06-30 weakness Rash around the mouth currently, lips are swollen and are peeling. Fever, chills, weakness.
83 2021-07-11 restless legs syndrome, weakness, numbness Numbness, starting at feet going upward to entire leg. Weakness in muscle affected by polio (legs). ... Read more
Numbness, starting at feet going upward to entire leg. Weakness in muscle affected by polio (legs). Unexplained physical and mental fatique, wants to sleep all the time. Trouble walking up and down stairs or around curves. Chronic joint and muscle pain. Restless legs. Trouble with swallowing. Cold intolorance. Sleep disorders. Low endurance. Memory and concentration problems.
83 2021-07-12 numbness I am an 83 year old female who was thought to have Guillain-Barre ca. 40 years ago. I was paralyzed... Read more
I am an 83 year old female who was thought to have Guillain-Barre ca. 40 years ago. I was paralyzed from the waist down, hospitalized, and had a very slow recovery. This paralysis caused clawed toes that were straightened surgically and affected my balance and walking (I use two hiking poles as aids for walking and balance.) Little was known at that time. I received the first Pfizer Covid shot on April 18, 2021. Two days after I had the Covid shot, the nerves in my left leg, below the knee, were sore when pressed and the affected muscles felt numb. This has persisted and at times different nerves in my lower leg are affected. Currently the muscles going down the back of my lower leg and around the ankle are affected. Three nights after the Covid shot, I had severe left kidney pains, became violently sick and the following morning went to my health facility emergency care department. I had no previous kidney problems or signs of a UTI. I had a CT scan of the kidney and was treated for a kidney infection and UTI with antibiotics. I have been to a kidney specialist and urologist with tests continuing. My breathing was erratic for a few days and I felt nauseous for 2 weeks. I have not had the second covid shot.
83 2021-07-14 numbness 9 pm chills 4am found myself about to hit the floor was not aware of fall until I was about a foot ... Read more
9 pm chills 4am found myself about to hit the floor was not aware of fall until I was about a foot from hitting floor Tried to get back in bed but felt like I had no knees or lower legs laid on floor for unknown time Unsure How I got back in bed but I was and need to throw up. With no use of legs throw up on floor 9 am tried to go to toilet but again fell as still had no use of legs. So did so on the floor.. removed wet pants Slept from 9:30 am until 5 pm. Friend came over and helped me get up. Had 70% of leg use back. Ate a cracker and drank water and went back to bed at 7 pm and slept til 9 am Now it is 2 days after shot and finally have leg control but sweaty All this time for the 3 days had body aches and head ach. Took 5 days before I was back to normal
83 2021-07-17 pain in extremity Labored breathing; chest pressure; fatigue; chest felt very tight; she is not planning to get her se... Read more
Labored breathing; chest pressure; fatigue; chest felt very tight; she is not planning to get her second vaccine; because has vertigo besides this; she can't swallow; Wheezing; got very sick; pains all over; headache; neck pain; arm pain; bone pain; This is a spontaneous report from a contactable consumer (patient). A 83-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: GWO196), via an unspecified route of administration in Arm Left on 24Jun2021 at 04:00 (83-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included bl high cholesterol; reported that her body makes cholesterol, it is not what she eats. It is 350 sometimes, 300 is high. Asthma, swollen, blood pressure, allergy with some soaps, adhesives they have to put one with cloth that does not have the same qualities as adhesive or otherwise she gets a rash, history of stents for heart attack, couple of arteries clogged but not showing any signs of causing problems, cancer. The patient had allergy with some medicines like clindamycin, Percocet, Percodan, penicillins. Concomitant medications included amlodipine (AMLODIPINE, dose: 5 mg, 1x/day) taken for blood pressure; atorvastatin (ATORVASTATIN, dose: 40 mg (she has been taking for years)) taken for blood cholesterol; furosemide (LASIX [FUROSEMIDE, dose: 20 mg (for three years. Not every day)]) taken for when her legs get swollen; salbutamol sulfate (VENTOLIN ACCUHALER) taken for asthma. It was reported that amlodipine was taken 3 or 5 years she has been on, but does not remember off hand, atorvastatin was taken maybe 8 years, it runs in her family everybody has it. She has been taking all her medications 50 years but not her cholesterol medication, for Lasix she is running like a chicken with her head cut off because everything that has happened to her. She takes 20, her daughter takes 40 mg not every day, for Ventolin when foggy outside she gets wheezy and when she is outside walking, she does one spray once and that is it. Years ago, she had bad asthma but not in the last 5 years except with weather. The patient previously took flu vaccine vii every year and experienced her arm hurt a little bit, coughing, chest hurt, did not have breathing thing, she got the flu, fainted. Reported that she was getting the flu vaccine every year, she takes it, and was okay the first time but her arm hurt a little bit and it never hurt. Two years ago, she took it and 2 weeks later felt sick like coughing and her chest hurt and she did not have breathing thing. Coughing and chest hurting led to her going to the emergency because she also fainted, so she called # and they took her to the hospital. She did tests and it was not her heart. They tested her for the flu and she said oh I already got my flu shot and they said well good thing you did. Caller confirms she got the flu after getting the flu shot. Reported that after experiencing labored breathing, chest pain, she called a cardiologist and went to the doctors and was admitted to the hospital for cardiac testing, and complains of labored breathing and fatigue. She wants this documented and has a history of stents in the past but hospital workup was negative. She had a heart attack 3 years ago and has stents in her heart. What happened when she called, she had cancer 5 years ago, when she called the oncologist and told him he said call cardiologist and she told her that she had the vaccine. She was taken by ambulance to the hospital and they did a bunch of tests and electrocardiogram and xrays and put her on monitor. After a few hours, they sent her to the cardiac floor where they gave her an injection, more blood tests, more of everything. The next day, nuclear testing of the heard and all of that stuff and sent her home and said it was not her heart and it was fine. She still had a couple of arteries clogged but not showing any signs of causing problems so they do not have to put a stent in. Caller confirms this was prior to receiving the vaccine because she has arteries clogged but only one with a stent and she still does not need a stent. No history of previous immunization with the Pfizer vaccine considered as suspect. No prior Vaccinations within 4 weeks. Reported that after vaccination they left her there for the 15 minutes and she had no reaction and came home and said my God, I should have done this a long time ago, because her arm was perfect and did not hurt and she had no symptoms till 2 o'clock in the morning. Reported that she is not planning to get her second vaccine. The second one she hears has worse and more side effects. She does not know what is going to happen if she only has one. She is supposed to have one 15Jul2021 in a couple days and right now she cannot take it if she is feeling this way because it is impossible and how should she do it if she is sick. Reported that Dr was afraid she was having a heart attack because she felt think someone was squeezing her chest and her breathing wasn't normal, so the hospital did all kinds of cardiac evaluation and they admitted her to the cardiac floor and continued to have all kinds of cardiac testing done, turns out her heart was okay, even though she has a stent in her heart and has 2 arteries that are clogged but they do not need to be fixed because there are not clogged to the point where it would cause her any problems, All the test showed that she did not have a heart attack. She has a lot of fatigue, if she walks from the bedroom to the kitchen, she really tires and feels like her breathing is labored, it's awful, and pains in the neck, even though before used to have a little pain in the neck, because has vertigo besides this but now has to be putting Ice packs constantly on the neck, waits and hour and then again and takes Motrin for the pain. Also the muscles, the doctor says the muscle in the chest, not in her heart and when she touches it hurts. Also having episodes where she can't swallow like she used to and had Asthma but kinda went away and now has started the past 2 days having Asthma, always has a pump with her because when it is foggy out she gets a little wheezing since yesterday, when she wakes up in the morning she hears the wheezing so will take a puff from the inhaler, so she would like this to be registered because she is 84 year old lady and has some issues that she never had other than when she had a heart attack, to which she had to change her medication. On 26Jun2021, the patient experienced labored breathing, chest pressure, fatigue, chest felt very tight, on an unspecified date, the patient experienced she is not planning to get her second vaccine, because has vertigo besides this, on 07Jul2021, the patient experienced wheezing, on 24Jun2021, the patient experienced got very sick, pains all over, headache, neck pain, arm pain, bone pain. It was reported that some term highlighted by the reporter as Labored breathing, chest pressure, fatigue. It was reported that it was not chest pain but it was pressure like somebody was squeezing her heart or had a rock on it and it weighed 100 pounds. It has gotten worse now that she is having wheezing in the morning. She had to use an inhaler for asthma yesterday. It has not gotten worse but it is the same. AE(s) require a visit to emergency Room and physician Office and hospitalized for one day. The patient was hospitalized for labored breathing, chest pressure and fatigue and chest felt very tight from 30Jun2021 to 01Jul2021. The patient underwent lab tests and procedures which included blood test resulted as unknown results, height resulted as 149.86 cm which she think shrunk and got fat, she used to be 4'11", electrocardiogram resulted as unknown results, nuclear testing of the heard resulted as it was fine, weight resulted as 100 lbs on 26Jun2021 which rock on it and it weighed 100 pounds, x-ray resulted as unknown results. Reported that all tests were negative but they put her in for her heart and no other reason to keep her because she did not need any kind of procedure done. Once they found it, she went home. Patient received treatment for events (labored breathing, chest pressure, fatigue, chest felt very tight, wheezing, pains all over, neck pain. The outcome of events Labored breathing, chest pressure, fatigue, chest felt very tight, Wheezing was not recovered, the outcome of events she is not planning to get her second vaccine, got very sick, pains all over, headache, neck pain, arm pain, bone pain, because has vertigo besides this and she can't swallow was unknown.
83 2021-07-21 pain in extremity, burning sensation, breast pain she experience a burning sensation that right side where she got the injection, the sensation went u... Read more
she experience a burning sensation that right side where she got the injection, the sensation went up her neck and into her throat.; She states that she had an odd taste in her mouth, but it was not metallic, just a funny taste in her mouth; Her stomach cramped up a little bit as well.; muscle pain in the back of her neck that did last for a couple of days; A little bit of pain in the left breast; Pain in arm; She states that a couple dats after taking the vaccine she got up to walk (she walks with a walker when she is able to, other wise she uses a power chair) the pain in her hip wasn't there.; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team. A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN0186, Expiration date: unknown), dose 1, via an intramuscular route of administration, administered in Arm Right on 23Jun2021, (at the age of 83-year-old), as dose 1, single for covid-19 immunisation. Patient medical history included ongoing Arthritis (she had arthritis as a teenager but did not know it. She reported that she was diagnosed with arthritis years ago in her late 40's), ongoing Heart condition (she has a heart murmur and she believes that she was born with it),ongoing High cholesterol (she was diagnosed with high cholesterol many years ago and she cannot remember when), ongoing Hypoglycemia (she was diagnosed years ago), ongoing Macular degeneration (the macular degeneration began years ago and that is why she is now legally blind), ongoing Asthma (she was diagnosed years ago and it goes along with the allergies), Cancer (she reported that she had cancer surgery on her left breast), Diverticulitis, lumpectomy in the late 1990s, Covid-19, ongoing Osteoporosis (she was diagnosed with osteoporosis years ago), Colon resection in the 2000's and guesstimate around 2011. Patient reported that her last surgery was for diverticulitis in the 2000's, she wants to guestimate around 2011. She reported that her diverticulitis has been pretty good since the surgery. She reported that once in a while she has a little discomfort. She reported that she was not sure if the diverticulitis was causing the pain in her hip area as that is where the colon resection was done. She reported that she was not sure if was arthritis or osteoporosis or the other stuff. Family Medical History Relevant to AE(s) was none. She has allergies to strong odors and stuff like that and some foods like berries, strawberries, and chocolate cause her to break out in pimples and a rash and allergy to pollock, the fish. She has allergy to unspecified medications caused her to break out with hives really bad. She had most allergies to NSAIDs medications. The patient concomitant medications were not reported. The patient historical drugs included Lescol, Zocor, Lobid, Lipitor, Celebrex, salicylate, Darvocet, clarithromycin, erythromycin, Lyrica, Crestor, Zoloft, Zyrtec, Vicodin, Limbrel, and Vioxx and experienced allergies. She reported that she carries a list with her of her medication allergies so that she is not prescribed anything she is allergic to. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. On 23Jun2021, within the first 5 minutes of receiving the Covid-19 vaccine, the patient experienced a burning sensation that right side where she got the injection, the sensation went up into her neck and throat, felt odd taste, Her stomach cramped up a little bit as well, muscle pain in the back of her neck that did last for a couple of days, A little bit of pain in the left breast and Pain in arm and Pain in left hip is not there within a day or day and a half of receiving the Covid-19 vaccine, She states that a couple days after taking the vaccine she got up to walk (she walks with a walker when she is able to, other wise she uses a power chair on an unspecified date in Jun2021. The clinical course of the events as follows: She reported that within 10 minutes while waiting, she first experienced a burning sensation on the right side where she got the Covid-19 vaccine injection. Caller reported that the burning sensation went up into her neck and throat, also felt an odd taste that she could not distinguish, not a metallic taste, but kind of a funny feeling with her throat, an odd feeling, she reported that a couple of minutes later, she felt cramping in her stomach and later on in the afternoon, a couple hours later, she had real severe muscle pain in the back of her neck, severe muscle pain in the back of her neck lasted quite a while, for a couple of days, pain in her arm developed the evening of 23Jun2021 and she felt it for a day and a half. She stated that they say that the arm pain was normal but the other things she was not quite sure about. she did feel a little bit of pain in her left breast, she had cancer surgery on her left breast and that the pain was probably in the lymph node area. Caller inquired if these are just normal side effects for people to get and not to worry about the second Covid-19 injection. She reported that the burning sensation, odd taste in her mouth, and funny feeling in her throat only stayed a little while. Muscle pain in back of neck lasted 2-3 days, little bit of pain in the left breast lasted 2-3 days, cramping in stomach lasted a couple of days. Pain in left hip is not there: she reported that she has a lot of senior problems and one of them is that she has arthritis from head to toe. Caller reported that in her left knee and hip on the inside of the hip area, she has severe pain. She reported that she has minimal walking ability and uses a wheelchair but uses a walker in the house when she has good days. She reported that within a day or day and a half of receiving the Covid-19 vaccine, she got up to walk to the kitchen and the pain in her left hip was not there and reported that it was really weird, and she was grateful of course, but her left hip is still ok. She reported that when she was on her feet and walking, she does not have the severe pain that used to put her off her feet. She reported that when she was laying down in bed and stretching, she feels severe pain, but walking around it's better. She reported that the pain in her left hip was not there when she was walking and that used to be when it was the worst. She reported that her second dose of the Covid-19 vaccine would be due for 14Jul2021. She reported that she knows that the vaccine is still experimental and that there are side effects, but it was better to take chances on the Covid-19 vaccine than to get Covid. She reported that one of her distant family members that got Covid got really sick, and they were young. She reported that she just wanted to make sure that these side effects would not prevent her from getting the second dose of the Covid-19 vaccine. She reported that the side effects were not severe but were annoying. The events did not require a visit to Emergency Room and Physician Office. Relevant Tests were none. No Investigation Assessment was done. she said that she had not heard of those side effects and it was nothing severe and not to worry. She reported that the girl instructed her that if she did have an allergy, she had to wait 6 hours to take an allergy pill. the outcome of the events burning sensation that right side where she got the injection, the sensation went up her neck and into her throat, felt odd taste was resolved on 23Jun2021, the outcome of events Cramping in stomach, muscle pain in the back of her neck that did last for a couple of days, little bit of pain in the left breast and Pain in arm was resolved on an unspecified date in Jun2021, while outcome of other events were unknown.
83 2021-07-25 weakness Patient presented to emergency department on 7/24/2021 with complaints of shortness of breath, weakn... Read more
Patient presented to emergency department on 7/24/2021 with complaints of shortness of breath, weakness, fatigue, bloody stool. Also reports having chills and has a mild cough. Patient has COPD.
83 2021-07-26 pain in extremity Developed large swelling under and around left breast. . Under left arm it will hurt real deep once ... Read more
Developed large swelling under and around left breast. . Under left arm it will hurt real deep once in a while.
83 2021-07-28 night sweats Lost 5 pounds; one bout of diarrhea; night sweats so bad; nausea and vomiting; headaches; nausea and... Read more
Lost 5 pounds; one bout of diarrhea; night sweats so bad; nausea and vomiting; headaches; nausea and vomiting; diagnosed with bronchial pneumonia; This is a spontaneous report from a Pfizer Sponsored Program. Information was received from a contactable nurse (the patient). A 83-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 12:30 (Batch/Lot Number: EL6204) as single dose for covid-19 immunisation (Age at vaccination 83 years) . Medical history included mycobacterium avium complex infection. On 24Feb2021 the patient received the first dose of BNT162B2 vaccine. Concomitant medications included multivitamin (MULTIVITAMIN) taken for an unspecified indication from 19Mar2021 12:30 to 19Mar2021 12:30; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX (B50)) taken for an unspecified indication, start and stop date were not reported. The patient was diagnosed with bronchial pneumonia (medically significant) on Mar2021 with outcome of recovered , lost 5 pounds (non-serious) on an unspecified date with outcome of recovered , headaches (non-serious) on Mar2021 with outcome of recovered , nausea and vomiting (non-serious) on Mar2021 with outcome of recovered , one bout of diarrhea (non-serious) on an unspecified date with outcome of recovered , night sweats so bad (non-serious) on Mar2021 with outcome of recovered. Therapeutic measures were taken as a result of diagnosed with bronchial pneumonia and included antibiotics, albuterol and cough medicine. Course of the event. Caller states that she then had a sore throat and nasopharynx and throat felt like she was breathing fire. It got worse and worse. Caller states that within 48 hours of receiving the vaccine, she also began coughing and coughing. She had headaches, nausea, vomiting, one bout of diarrhea, and night sweats so bad that she had to change her pillow and bedding and was soaked from the waist up. Caller adds she was diagnosed with bronchial pneumonia. She had an appointment with a pulmonologist doctor and was seen at the clinic. They did x-rays, cat scans, and she was unable to do a breathing test because she could not quit coughing. Caller does not have additional details. Gave her antibiotics for 21 days, a nebulizer of albuterol and saline and they gave her cough medicine. It was the same cough medicine with codeine. She spent 6 days just at the clinic with tests in the doctor and came home from the train. Caller adds she was not admitted. This all stretched out over 3 weeks and gradually increased. Follow up information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The contribution of patient's age cannot be completely ruled out in the occurrence of the events. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
84 2021-01-12 weakness tired, no energy, brain fog
84 2021-01-12 feeling hot Warm, Sore
84 2021-01-14 pain in extremity Sore arm, fatigue
84 2021-01-22 numbness 10 minutes after vaccination patient felt tingling sensation in Left Arm and numbness in finger. Pt ... Read more
10 minutes after vaccination patient felt tingling sensation in Left Arm and numbness in finger. Pt was observed closely and then went to bed after 1/2 hours of receiving vaccine
84 2021-01-27 weakness, feeling cold Patient felt cold/weak, but no rash after the vaccine was administered. Brought to lie down in the o... Read more
Patient felt cold/weak, but no rash after the vaccine was administered. Brought to lie down in the observation area. Given water and had BP monitored. Stabilized and went home.
84 2021-01-27 bell's palsy Site: Bruising at Injection Site-Mild, Systemic: Other- Bells Palsy-Medium
84 2021-01-28 cold sweat 2:30p: I was called to assist pt as she was having a rxn to COVID vaccine. Had vaccine 10 minutes pr... Read more
2:30p: I was called to assist pt as she was having a rxn to COVID vaccine. Had vaccine 10 minutes prior. Found pt pale, diaphoretic lips, cool and diaphoretic. Did not respond to name. Assisted pt to floor and elevated feet. Pt immediately opened eyes and was oriented x 3. BP 120/82. 2:35p: Pt awake, alert and oriented x 3. Color pinker and drier, cool compress to forehead. 2:37p: Pt remains asymptomatic, assisted pt to sitting position. 2:39p: Pt color pink, skin w/d. 0 c/o's. Assisted pt to wheelchair. Nurse from ER here and accompanied pt to ER.
84 2021-01-31 feeling cold headache off and on, severe coldness and some chills, diahrrea for 48 hours
84 2021-01-31 pain in extremity Swollen lump that is quite sore on her left arm; Swollen lump that is quite sore on her left arm; Th... Read more
Swollen lump that is quite sore on her left arm; Swollen lump that is quite sore on her left arm; This is a spontaneous report from a contactable Nurse (patient). A 84-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, Expiry Date: Apr2021) via an unspecified route of administration in Jan2021 at single dose for vaccination. Dose injection to left deltoid around 14:00. Medical history included car wreck, hypertension, scoliosis. Concomitant medication included ongoing celecoxib (CELEBREX) for car wreck, amlodipine besilate, benazepril hydrochloride (AMLODIPINE/BENAZEPRIL) from 2017 and ongoing for anti-hypertension. The patient reported she had the Pfizer COVID-19 Vaccine a week ago and it did not really bother her until she started trying to do exercises of her arm. On 15Jan2021 she had a swollen lump that is quite sore on her left arm that did not go down and it had been 3 days now. She did not have a fever, the area was not red, it's just swollen. She just wanted to know if this event was customary with the product; and if her second dose should be given in a different anatomical location. It was just painful and swollen; had not been hospitalized for this event. She could see the difference, she was quite wrinkled now with age; but at the site of her swollen lump on left arm she had no wrinkles right now. Her second dose is scheduled for 02Feb2021 at 14:20. The outcome of events was not recovered.
84 2021-02-01 weakness Two days, 1/29 ,after shot, vomiting and fatigue, emergency room visit on 1/31 , additional ER visi... Read more
Two days, 1/29 ,after shot, vomiting and fatigue, emergency room visit on 1/31 , additional ER visit on 2/01. Continual slight stomach upset but general fatigue and weakness still prevalent.
84 2021-02-01 feeling cold really sick; In bed 2 days; Could not eat; Hurting all over and joints aching; Hurting all over and ... Read more
really sick; In bed 2 days; Could not eat; Hurting all over and joints aching; Hurting all over and joints aching; Fever and really cold; Fever and really cold; Left arm was sore after injection; Left arm was sore after injection and she had a lump and was itching; Left arm sore after injection with lump and itching; This is a spontaneous report from a contactable Nurse reported for mother. An 84-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via intramuscular at arm left on 13Jan2021 13:00 at single dose for prevention because of age group. Medical history included hypothyroid diagnosed many years ago, having Covid in Jun2020. Concomitant medications were unknown. The patient was really sick from an unspecified date. The reporter was starting to wonder if the patient should take the second dose. The patient was in bed for 2 days, could not eat and was hurting all over at 23: 00 on 13Jan2021. Her joints were aching at 23: 00 on 13Jan2021. She had a fever and not really chills, but she just never could get warm and was really cold at 23: 00 on 13Jan2021. She went to bed and woke up on that same date, 13Jan2021, and it started at 11pm. She guessed it was disabling. As it went on, it got better. By Friday, she was finally able to eat. She has plenty of weight to fall back on for not eating. By Friday, she started eating again. She was still not back to normal yet though. She just felt like she could not get up. The fever only went on for a few days. Left arm was sore after injection and she had a lump and was itching 13Jan2021. It worried her. The lump was still itching and sore, but was getting better. Reporter stated that the shingles vaccine did the exact same thing to her with the lump under her skin and itching. It was given on her hip because she had small arm and they were scared to give it in her arm. The reporter wanted to know if there were elderly people in the trial and did any of them have COVID. No additional vaccines administered on same date of the pfizer suspect. Seriousness for In bed 2 days was reported as disabling. Seriousness for Could not eat, Fever and really cold was reported as not serious. Seriousness for Left arm sore after injection with lump and itching was reported as medically significant. Outcome of the events Fever and really cold, really sick was unknown, of other events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
84 2021-02-01 pain in extremity Per husband: "Wife developed severe chicken pox all over body. Wife got shock- for two days, she had... Read more
Per husband: "Wife developed severe chicken pox all over body. Wife got shock- for two days, she had sore shoulder, on the 3rd/4th day she starting developing rash on site where she got the shot. Then rash spread to her other side and now rash has spread all over the body. Thought it would go away in a day or two, but hasn't. She has had the rash for 8 days." Further investigation on interview: It started approximately 3-4 hours after vaccination. First a sore arm then it felt itchy. She then noticed red raised spots. This rash has resolved slowly but "almost back to normal" as of Feb. 1. She still wants to get her second dose on Feb. 2 as scheduled.
84 2021-02-02 pain in extremity About 2 hrs after the injection my arm/needle site and shoulder and down my arm to my hand had pain.... Read more
About 2 hrs after the injection my arm/needle site and shoulder and down my arm to my hand had pain. My arm can;t lift up to comb my hair. I have limited motion and pain
84 2021-02-02 tremor Patient reported being shaky, feeling of a full tongue, VS stable MD notified
84 2021-02-03 weakness Chills, weakness, light headed, slight nausea , slight arm pain at injection sight. Only treatment ... Read more
Chills, weakness, light headed, slight nausea , slight arm pain at injection sight. Only treatment was go to bed
84 2021-02-03 weakness Generalized weakness and body aches. Clinic stated that the pt was anxious and was "not feeling good... Read more
Generalized weakness and body aches. Clinic stated that the pt was anxious and was "not feeling good". Pt states she feels SOB. O2 is 97% on RA. Pt does have bilateral edema in lower extremities. Pt does have a history of dementia. Clinic sent patient to the emergency room due to these symptoms.
84 2021-02-03 pain in extremity Sore arms and hands. Sore stomach muscles........during the night after the shot ....by morning all ... Read more
Sore arms and hands. Sore stomach muscles........during the night after the shot ....by morning all aches were gone
84 2021-02-04 weakness I just got done going to the bathroom (2-4-2021) and was zipping up my pants when I fainted. I fel... Read more
I just got done going to the bathroom (2-4-2021) and was zipping up my pants when I fainted. I fell backwards into the bathtub knocking down both shower doors. My legs were hanging over the edge of the tub. One shower door fell on my upper right chest area. This happened just over 24 hours from when I received the vaccine. I had not felt bad at all from the vaccine. Didn't sleep too well that night (2-4-2021) because I hurt due to the fall. I called my doctor on 2-5-2021 to let her know I fainted 24 hours after receiving the vaccine and wondered if that was due to it. I do feel weak today (2-5-2021).
84 2021-02-04 unresponsive to stimuli Narrative: Patient with history advanced vascular dementia, hypertensive cerebrovascular disease and... Read more
Narrative: Patient with history advanced vascular dementia, hypertensive cerebrovascular disease and stroke, T2DM. Received her second dose of Pfizer COVID-19 vaccine at approximately 14:00 and was reported to have expired at home at 20:55. Dr. (Medical Director) spoke with patient's son/caregiver 2/4/21. Son reports that patient was in her usual health yesterday morning, deemed well enough by son to travel for vaccination. He reports she had no bothersome symptoms after either first or second vaccinations. Specifically denied rash, wheeze, and difficulty breathing. Son was with patient throughout the day. In the evening, when preparing for bed, he noted she became suddenly unresponsive in a similar fashion as she has done several times in past years. While in all previous such episodes she recovered within minutes, last evening she did not regain consciousness, experiences a brief period of labored breathing, and died. Patient's son called 911 and the patient's body was brought to the medical examiners. The medical examiner declined to proceed with autopsy. Patient's son is not interested in autopsy. Patient's son reports confidence that his mother's underlying hypertensive/diabetic cardiovascular disease is the natural cause of her death. Other Relevant Hx: Symptoms: & Death Treatment:
84 2021-02-07 weakness Patient is a 84-year-old female presenting to the emergency room with anxiousness, generalized weakn... Read more
Patient is a 84-year-old female presenting to the emergency room with anxiousness, generalized weakness and one episode of vomiting/nausea surrounding her Covid vaccination this afternoon. On exam patient appears mildly anxious, has no evidence of allergic reaction, lungs are clear and equal bilaterally. Patient is resting comfortably, speaking in complete sentences. Shortly after physical exam patient was noted to have oxygen saturation of 90 to 92%, subsequently placed on 2 L nasal cannula. Will obtain CBC, CMP, chest x-ray, EKG. We will also give patient 500 cc of fluid and 4 mg of Zofran for control of nausea and vomiting. We will continue to monitor patient. No leukocytosis, no AKI, electrolytes within normal limits, chest x-ray without evidence of underlying pneumonia or pneumothorax. I have reevaluated patient, patient has been reporting a ongoing headache for which she has a history of and takes Fioricet, requesting Fioricet. Will order Fioricet. We attempted to take patient off of her oxygen however when taken off the oxygen she drops to 88% on room air. Patient reports ongoing generalized weakness and nausea which has required an additional 4 mg Zofran. Given that patient has been monitored for couple of hours and has had ongoing nausea and vomiting, generalized weakness in the setting of hypoxia when taken off of oxygen will obtain troponins and admit patient to the hospital for obs. I have spoken to Dr. who has accepted patient to observation with telemetry for further management. Patient was informed of admission status, with no further questions at this time.
84 2021-02-07 weakness Fever, headache, nausea, weakness, dizziness
84 2021-02-07 pain in extremity pain in her knees that went down to her feet; pain in her legs/ went down to her feet; maybe it was ... Read more
pain in her knees that went down to her feet; pain in her legs/ went down to her feet; maybe it was arthritis; can't hardly walk; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1284 and Expiration Date unknown) via an unspecified route of administration on 09Jan2021 (vaccine location: left arm) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was reported as none.On Monday (11Jan2021) morning she had a lot of pain in her legs and knees that went down to her feet. She thought maybe it was arthritis, but it was still there and it still hurts. She can't hardly walk real good cause it hurts. She was wondering if it could be a side effect from that vaccine. She wanted to know if there been a reaction like this in other people. Supposed to get her second dose on 30Jan2021. The outcome of events was not recovered without treatment involved. No follow-up attempts are possible. No further information is expected.
84 2021-02-08 weakness, unresponsive to stimuli Resident was weak, fatigued and had a fever of 101. F the following morning after receiving the 2nd ... Read more
Resident was weak, fatigued and had a fever of 101. F the following morning after receiving the 2nd dose of vaccine. Later in the day she was feeling better and vital signs were WNL. The next morning, she was found unresponsive and pronounced dead by paramedics.
84 2021-02-08 tingling Pt felt a chest and stomach burning about 10 minutes, throat tightness, and tingling around her mout... Read more
Pt felt a chest and stomach burning about 10 minutes, throat tightness, and tingling around her mouth
84 2021-02-08 tingling "Started to have a rash on rt side of her face, along with dizziness, weakness and tingling in he... Read more
"Started to have a rash on rt side of her face, along with dizziness, weakness and tingling in her rt arm. Rapid response team called and came, RRT took her to ED"
84 2021-02-09 weakness Patient received her first covid vaccine on 1/27/21. on 1/30/21 she presented to the emergency depar... Read more
Patient received her first covid vaccine on 1/27/21. on 1/30/21 she presented to the emergency department complaining of nausea, she had a negative work up, felt better and was sent home. on 2/5/21 she returned to the emergency department more ill-appearing and complaining of "feeling sick". she had fatigue, chills, decrease in activity level. her work up at this visit revealed multiple metabolic abnormalities, sepsis and bacteremia. She ultimately passed away at this visit with at cause of death listed as acute liver failure, pneumonia, and DIC>
84 2021-02-09 tremor Patient was brought in by ambulance on 01/28/2021 with complaints of fever, chills, myalgias, shakin... Read more
Patient was brought in by ambulance on 01/28/2021 with complaints of fever, chills, myalgias, shakiness, and severe hypotension. Patient was treated for severe sepsis and acute kidney injury. Patient was given fluid resuscitation, but unresponsive to treatment; NE+ vasopressin, hydrocortisone IV, along with empiric antibiotic regimen were initiated. Patient later on developed pulmonary edema, Non-ST elevation MI with no chest pain and new onset of cardiomyopathy with EF 40-45% and clean coronary arteries shown on cardiac catheterization. Physician suspected cytokine release syndrome related to the COVID vaccine and congestive heart failure. Naranjo scale score of 2 indicates possible ADR. MD indicated vaccine reaction unlikely.
84 2021-02-10 weakness weakness, low BP 92/43, low HR 36, less responsive, shallow breathing - chest compressions - Vitals ... Read more
weakness, low BP 92/43, low HR 36, less responsive, shallow breathing - chest compressions - Vitals improved
84 2021-02-10 pain in extremity, weakness fast heartbeat; increased BP; weak; dizziness; nausea; headache; confused; a little soreness in her ... Read more
fast heartbeat; increased BP; weak; dizziness; nausea; headache; confused; a little soreness in her arm; felt like she could pass out; didn't know who she was, she just kept walking and walking; funny feelings; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142, expiry date not reported), via an unspecified route of administration on the right upper arm on 21Jan2021 17:00 at single dose for covid-19 immunization. Medical history included oral cancer from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received flu vaccine for immunization and reported that it made her sick for 10 days 4 or 5 years ago. The patient previously took Tylenol (takes 1 instead of 2, Everything she takes half the recommended dose). The patient experienced fast heartbeat, increased BP, weakness, dizziness, nausea and headache on an unspecified date in Jan2021. It was further reported that she had a fast heart beat, her blood pressure went real high, she was dizzy and weak. This was while she was there and being watched for the 15 minutes by a nurse. She is 84 years old and doesn't take any medication; she did have oral cancer but with no chemo as it had not spread and this was 2 years ago. It was explained that the patient didn't feel good about it but she drove home. When she got home she was confused and felt like she could pass out. She walked through the house didn't know who she was, she just kept walking and walking. It was a strange feeling that lasted 15-20 minutes. She called her son late in the afternoon and told him to check on her to make sure she made it through the night. She still had funny feelings over the next few days but at this point she only has the dizziness that happens occasionally. She notes also that her blood pressure was checked at home by her and was higher than normal the first few days after but is now normal. Over the next day she had a headache and a little nausea, but it was not severe. She also mentions having a little soreness in her arm but not bad. She did read about the side effects and states she had the elevated heart rate, increase in blood pressure and dizziness right after getting it. The patient wonders could she ask for smaller dose, she only weighs about 110lb. When she spoke with her doctor she was told that the COVID virus is worse than what she experienced after the vaccine. She has not been to the doctor since getting the vaccine, she just talked to them. The patient underwent lab tests and procedures which included blood pressure measurement: high and heart rate: fast on Jan2021. The patient was recovering from dizziness, the outcome of nausea was unknown and the patient recovered from the rest of the events on an unspecified date in Jan2021.
84 2021-02-11 facial paralysis Received vaccine 7:30 PM Monday, began feeling tinging in lower lip Tuesday, did not notice any symp... Read more
Received vaccine 7:30 PM Monday, began feeling tinging in lower lip Tuesday, did not notice any symptoms Wednesday, Thursday 11:00 AM noticed drooping left side of face, couldn't smile on left side, eye drooping, difficult to close left eye. Transported to ER by ambulance at 11:30 AM. Diagnosed with Bell's Palsy. Released from ER to home.
84 2021-02-11 pain in extremity Patient received 1st dose of vaccine on 2/6/21. That afternoon, developed malaise and fever/chills o... Read more
Patient received 1st dose of vaccine on 2/6/21. That afternoon, developed malaise and fever/chills over the next few days. On the evening on 2/9/21, began to have left-sided chest pain (severe, pleuritic, radiating to left arm) leading her to seek medical care. Was determined to have viral pericarditis and admitted to the hospital for several days
84 2021-02-17 brain damage Found down - day after vaccination. Fall, potentially acute encephalopathy / confusion, hypertensio... Read more
Found down - day after vaccination. Fall, potentially acute encephalopathy / confusion, hypertension (potential for non-compliance with antihypertensive medications?) - patient with known severe to advanced dementia / mild cognitive impairment. Likely related to hypertensive encephalopathy with post-COVID vaccine prodrome with underlying advanced dementia. Situation: hospitalization after a fall and hypertension emergency Background: Pt is an 84 y/o female pt with a log history of dementia, has been able to live alone safely until most recent illness/hospitalization. Assessment: Pt received her 2nd COVID vaccine on Saturday. On Sunday, pt's sister was unable to get a hold of her as her sister calls her daily due to her dementia. After several phone calls, her sister went to pt's home and found pt on her bedroom floor. There was some blood found, not sure from where. Sisiter was unable to get pt up so EMS was called and pt was taken to ED. She was evaluated, her BP was very elevated, she was admitted and testing was done. Head CT/MRI was unchanged. X-ray of her R shoulder shows a vertical non-displaced fracture of the greater tuberosity of the proximal humerous, no surgical intervention is recommended at this time, pt instructed to wear a sling for now. Pt is discharged home with Home Care and family support.
84 2021-02-18 pain in extremity The second dose was really my first covid vaccine shot. That evening for both, I started aching a ... Read more
The second dose was really my first covid vaccine shot. That evening for both, I started aching a lot in both arms and shoulders, couldn't sleep and extremely tired the next day. The following day I was back to normal and the symptoms gone. The second shot had a little stronger symptoms. I had covid in early November, 2020 in case that matters. Also, I had a flu shot late October and had a severe reaction which led to my being diagnosed with covid.
84 2021-02-21 inability to speak 1/23 - Mild injection site discomfort. Appetite loss compared to previous day. Beginning loss of men... Read more
1/23 - Mild injection site discomfort. Appetite loss compared to previous day. Beginning loss of mental acuity compared to previous day. 1/24 - Continued loss of appetite. Near complete loss of ability to move. Continued decline of mental acuity. Very little speaking. 1/25 - Stopped speaking completely. Loss of bowel control in the evening and continued until death. Complete loss of appetite. 1/26 - Near complete loss of ability to swallow. Moved to hospice 4:00pm. 1/27 - Died 4:00am
84 2021-02-23 weakness blindness in one eye; delirium; Weakness; This is a spontaneous report from a contactable consumer. ... Read more
blindness in one eye; delirium; Weakness; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left arm on 03Feb2021 11:15 at a single dose for covid-19 immunization. Medical history included congestive heart failure, diabetes, glaucoma, breast cancer survivor, high blood pressure and allergies. The patient has unspecified concomitant medications. On 03Feb2021 21:30, the patient experienced blindness in one eye, weakness and delirium. The patient did not receive treatment for the events. The events were assessed serious, disability. The patient has not tested positive to covid prior vaccination. The outcome of the events was not recovered. Information on Lot/Batch has been requested.
84 2021-02-25 discomfort, tingling, flushing pressure all in her head and all over her body; pressure all in her head and all over her body; Feel... Read more
pressure all in her head and all over her body; pressure all in her head and all over her body; Feeling flushed; Nausea; feel her heart beating; legs feet and hands would feel tingly; She went to bed around 1am. This went on all night off and on. She slept maybe about 3 hours total.; This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number: Unknown, Batch/lot number: EL9261, Expiry Date: 31May2021), via an unspecified route of administration in the left arm on 22Jan2021 at 0.3 mL, single for she did not got COVID. Medical history included continuing A-fib, takes medication for this everyday. Diagnosed at least 10 years ago. The patient's concomitant medications were not reported. Last night (25Jan2021) her symptoms started. She was unsure if it was from the vaccine or not but she was thinking it was, she had not had it before. Around 11 pm last night (25Jan2021) she got a pressure all in her head and all over her body. She felt flushed. She had nausea. She could feel her heart beating. She could really feel it. It was not abnormal. She did have A-fib, but this was normal, not like A-fib. Her took her blood pressure which was normal. She took her pulse which was normal. She went to bed around 1am. This went on all night off and on. She slept maybe about 3 hours total. Sometimes her legs feet and hands would feel tingly. And the flushing continue- it feels like her body was hot, but it was not hot to the touch. She had felt better this morning when she got up, but she did have one bout when she was just sitting here. She had improved overall. Caller stated she already spoke to the safety department but did not have any reference number to provide. The outcome of event 'Feeling flushed' and 'Sometimes her legs feet and hands would feel tingly' was recovered on 26Jan2021, of the other events was recovering.
84 2021-02-27 hot flush PT STATED THAT SHE WAS HAVING HOT FLUSHES AND PAPITATION , MD WAS NOTIFIED, VS WAS:163/65, T :99.6, ... Read more
PT STATED THAT SHE WAS HAVING HOT FLUSHES AND PAPITATION , MD WAS NOTIFIED, VS WAS:163/65, T :99.6, \SAO@:97, p:87, r:18@3:15. PT WAS EVELATIED BY MD , FLUID WAS ENCOURAGED, MD ORDERED CONTINUATION OF MONITORING PT , PT RESTED ON THE STRECHER FOR THE REMAING TIME, NO MORE DICOMFOORT COMPLAINTS FROM PT . VS CHECKE @3:30, BP :129/58, p :71, rr:18, SAO2:97. T: :99.5, VS CHECKED @3:58, \BP 131/58, p:82, \RR:18, SAO2:96, MD CAME TO CHECK ON PT @3:50, PT STATED THAT SHE FEELS FINE NOW , MD DIDD ANOTHER REEVALTION ON PT AND INSTRUCTED PT TO GO HOME , PT LEFT WITH HER AID NIA TAXI , NO MORE COMPLAINTS FROM PT.
84 2021-02-27 speech disorder, facial paralysis Received 1st dose Pfizer-BioNTech vaccine Lot EN9899 exp 03/2021 on 01/18/2021 during CVS onsite cli... Read more
Received 1st dose Pfizer-BioNTech vaccine Lot EN9899 exp 03/2021 on 01/18/2021 during CVS onsite clinic for Assisted Living Facility. Received 2nd dose Pfizer-BioNTech vaccine Lot EN5318 Exp 05/2021 on 02/08/2021 during CVS onsite clinic for Assisted Living Facility. On 02/10/2021 during routine employment screening, tested positive for COVID-19. On 02/12/2021 reported generalized malaise, otherwise denied symptoms. On 02/21/2021 employer notified by family friend that patient was treated at Medical Center on 02/20/2021 secondary to sudden onset difficulty swallowing, impaired speech, and facial droop. Employer later notified patient was then admitted to the ICU at aforementioned hospital secondary to dx of CVA.
84 2021-03-02 pain in extremity Itchy nose; Sneezing; sore arm; Swollen face; This is a spontaneous report from a contactable consum... Read more
Itchy nose; Sneezing; sore arm; Swollen face; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported) at age 84 years (as reported), via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing blood pressure high. Concomitant medication included warfarin sodium (COUMADIN). The patient previously received shingles vaccine (believes it was more than four weeks before getting the COVID vaccine). It was reported that the day after (26Jan2021), the patient experienced sore arm like everyone else. The sore arm has gone away, but does not know what day it went away. The day after the vaccine the patient had a swollen face (26Jan2021) and today it is worse; it is more swollen. On 01Feb2021, the patient experienced an itchy nose and sneezing. The outcome of the event sore arm was recovered on an unspecified date, the event swollen face was not recovered, while unknown for the events itchy nose and sneezing. Information on Lot/Batch number has been requested.
84 2021-03-02 pain in extremity terrible pain in leg and can hardly walk; terrible pain in leg and can hardly walk; This is a sponta... Read more
terrible pain in leg and can hardly walk; terrible pain in leg and can hardly walk; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown, reported as EL926S or EL9265), intramuscular (arm right) on 29Jan2021 at SINGLE DOSE for COVID-19 immunisation, at 84 years old. The patient's medical history included "nerve pain, neuropathy". Family history included Parkinson's (child). The patient previously received the first dose (arm left) of BNT162B2 (lot number ELO140) on 07Jan2021 for COVID-19 immunisation and experienced Slept the whole day. Concomitant medication included pregabalin (LYRICA) from an unspecified date for "nerve pain, neuropathy". No other vaccines were given the same day. It was reported that for COVID vaccine, there was a terrible pain in leg and can hardly walk on 30Jan2021. The pain in the legs was reported as getting worse. The adverse events did not require visit to the Emergency Room or Physician Office. Outcome of the event was not recovered. Information about batch/lot number has been requested.
84 2021-03-04 weakness she felt her blood pressure was up and so she checked, it was at 179; her sugar was down; Dizziness;... Read more
she felt her blood pressure was up and so she checked, it was at 179; her sugar was down; Dizziness; Weakness; Nausea/felt sick to her stomach; Diarrhea; Headache; Tiredness; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER VACCINE SHOT; lot number: EL3248; expiration date: unknown) at vaccination age of 84-year-old via an unspecified route of administration in the left arm on 29Jan2021 09:20 at a single dose for covid-19 immunization. Medical history included open heart surgery, diabetic/diabetes, high blood pressure, bone and joint problems, and her bones were already hurting for a long time before. She was calling because she was asked if she was allergic to anything, she is allergic to one medication, but she thinks they need to know more about her health conditions before giving this medication. Familial history included all of her family that has passed, died of diabetes or cancer. Concomitant medications included unspecified other blood pressure medication and nifedipine for blood pressure. The patient did not receive other vaccination within 4 weeks. The patient reported that she took the shot on 29Jan2021 and she stayed for the 15 minutes, but she didn't have any feeling about it. A little more than an hour later (29Jan2021), she had a slight headache, then she got tired and felt like she needed to lay down. She did lay down and slept 9 hours. The patient reported that she felt her blood pressure was up and so she checked, it was at 179 [unspecified unit]. It was at that point she called her children and told them she was not doing well. She does feel this is under control at this point. The next morning (30Jan2021), she had dizziness, weakness, felt sick to her stomach, and had a slight headache. She clarified that the sick to her stomach feeling was nausea and diarrhea both started on 30Jan2021. It had resolved as of 31Jan2021. She mentioned that she feels better but the tiredness is still going on today. It is explained that her blood pressure was up and her sugar was down on 30Jan2021, she is a diabetic. She takes blood pressure medication, but it wasn't bringing it down at first. She explained that when she took her blood sugar it was 70 [unspecified unit] something on 30Jan2021. Her normal is 120-121 [unspecified unit] (unspecified date) and that is where she likes to keep it so that was a problem. She has had to eat sweets to get it up, but it won't stay up. She reported that the tiredness, dizziness, and headache are still going on right now. She was calling because she was asked if she was allergic to anything, she is allergic to one medication, but she thinks they need to know more about her health conditions before giving this medication. She feels they should ask more questions or have the doctor send a recommendation over or information about a person. The outcome of the events headache was not recovered, as for the events dizziness and tiredness were recovering while the outcome of the events nausea and diarrhea were recovered on 31Jan2021. The outcome of the other events was unknown.
84 2021-03-04 weakness 2/23 - PT awoke at 0230 w/altered mental status, generalized weakness, severe headache, nausea and f... Read more
2/23 - PT awoke at 0230 w/altered mental status, generalized weakness, severe headache, nausea and fever. T 101.2, PERL, BP 120/82, HR 88 regular, RR 18. Grips/Pushes equal/weak. A&O x2 (A&O x 4 baseline). ABDM soft, non tender. Breath sounds clear bilaterally. 1100 IV NS 1L, 30 mg Toradol IV given. Temp 99.2-102.0 variable throughout the day. Severe HA. Tylenol and Motrin alternated q 4hr. 2/24 Severe Headache, pt reports disturbances in her visual field. A&O x3. weakness/malaise continues. Motrin & Tylenol - LABS 2/25 Severe Headache, with altered visual fields.- CT HEAD 2/26 Same as above. 2/27 Same as above. Urgent Care for Flu & COVID Testing. Both Neg 2/28 Headache managed with Celebrex, 12 hrs relief, then 200mg Motrin 3/1 Same as above. Retinal specialist for consult and Fluorescien Angiography - WNL 3/2-3/5 Headache and visual field changes continue. Pt states "do not feel myself"
84 2021-03-05 weakness She was week, fell, wouldn't eat, drink or get out of bed. Died after being sent to hospital 3 time... Read more
She was week, fell, wouldn't eat, drink or get out of bed. Died after being sent to hospital 3 times and ended up on hospice
84 2021-03-07 muscle spasms The day after the second COVID-19 Pfizer vaccine, the patient has bee experiencing persistent diarrh... Read more
The day after the second COVID-19 Pfizer vaccine, the patient has bee experiencing persistent diarrhea. Patient denies melena, but admits fatigue, frank red blood, and intermittent cramps. A full work-up is in process and no definitive diagnosis has been found as on 03/08/2021. However patient has bee stable and no hospital admission has been required as of 3/8/2021.
84 2021-03-07 pain in extremity Vaccine administered 2:30 pm March 4, 2021, March 6, 6:30 a.m. RIGHT hand was red and swollen could ... Read more
Vaccine administered 2:30 pm March 4, 2021, March 6, 6:30 a.m. RIGHT hand was red and swollen could not make a fist, Pain, in hand, wrist and elbow. March 7, 6:30 a.m. Improving. March 7, 4:30 PM could make a fist. March 8, 6:30 a.m. appears normal.
84 2021-03-11 flushing, difficulty speaking Pfizer COVID vaccine was administered at about 12:30 PM. Patient called staff over around 12:35 PM d... Read more
Pfizer COVID vaccine was administered at about 12:30 PM. Patient called staff over around 12:35 PM due to facial swelling, flushing and voice change. Benadryl was administered at 12:40 PM via IM in the Right Deltoid. At 12:45 PM pulse was 78, Respirations were 20, and BP was 118/84. At 12:50 PM pulse was 76, Respirations were 21 and BP was 140/90. At 12:55PM pulse was 72, Respirations were 19 and BP was 132/82. Patient denied ambulance services. Stated that she felt better at this time. Monitored patient for a total of 30 minutes and stated she felt fine at that point. Patient was followed up with the next day. She stated that no more Benadryl was needed at home. She slept a few hours after and continued to have slight facial swelling that lasted for a couple of days. Patient is unsure if she wanted to get the 2nd dose, but wanted to keep her appointment for it still. Her doctor recommends getting the second vaccine dose and told her to just take Benadryl and Pepcid before the vaccine. We educated her about the possibility of getting that second dose at her doctor's office or at Hospital in order for her to have more immediate access to emergency care.
84 2021-03-13 tenderness, pain in extremity 1. VERY TENDER DELTOID AND UPPER LEFT ARM. 2. GENERALIZED ACHING OF ENTIRE BODY. 3. UNABLE TO SLE... Read more
1. VERY TENDER DELTOID AND UPPER LEFT ARM. 2. GENERALIZED ACHING OF ENTIRE BODY. 3. UNABLE TO SLEEP FOR 6 HOURS. 4. TOOK 500 MG TYLENOL. 5. ACHING AND LOW-GRADE TEMPERATURE CEASED. 6. FELL ASLEEP FOR 8 HOURS. 7. AWOKE AND PAIN HAD SUBSIDED. 8. DID NOT INGEST FOOD BUT DID DRINK WATER. 9. ON 03/11/2021 AWOKE AND EXPERIENCED NO FURTHER PROBLEMS.
84 2021-03-14 pain in extremity, tingling sudden, severe leg pain, muscle weakness,pain on bending knees, worsened chronic back pain , tingli... Read more
sudden, severe leg pain, muscle weakness,pain on bending knees, worsened chronic back pain , tingling i n feet
84 2021-03-14 pain in extremity restless; tired; head hurt; arm hurts; body aches; cold chills; couldnot sleep; tongue burning; This... Read more
restless; tired; head hurt; arm hurts; body aches; cold chills; couldnot sleep; tongue burning; This is a spontaneous report from a contactable consumer (Patient's daughter). A 84-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Jan2021 19:00 (at the age of 84-years-old) as a single dose for COVID-19 immunization). Medical history included diabetes mellitus and arthritis from 20 years. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) at a dose of 200 mg as needed. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecifie date consumer stated her mom got the first shot of the Pfizer COVID 19 vaccine 28Jan2021 at 19:00PM in the right arm. After the shot she was fine but during the night her head hurt, she had body aches and cold chills, she was tired but she couldnot sleep because she was so restless and her tongue was burning up and she couldnot feel it. Clarified she can feel her tongue and it feels really hot. It was questioned that this a side effect of the vaccine. She was scheduled to receive the second dose of the vaccine on 18Feb2021. Added her mother took two Advil before the shot getting the shot because she was anxious and worried about the side effects. It was reported that the events couldnot sleep, tongue burning and tired were worsened. Outcome of the event cold chills was recovering and not recovered for other events. Information on the lot/batch number has been requested.
84 2021-03-15 pain in extremity, face paralysis, slurring, mild one side paralysis Client fell at home on the night of 01/29/21, woke up on 01/30/21 with left sided weakness, dysarthi... Read more
Client fell at home on the night of 01/29/21, woke up on 01/30/21 with left sided weakness, dysarthia, left sided facial weakness, left hand pain and swelling. Client transported via ambulance and admitted to Hospital. Transferred to rehab care on 02/02/21 and discharged on 02/16/21.
84 2021-03-16 speech disorder She got the vaccine, she had no effects, and no reaction whatsoever. The husband had no side effects... Read more
She got the vaccine, she had no effects, and no reaction whatsoever. The husband had no side effects either. On 3/16/21 they were on their way to go to bed and the bedroom is upstairs and she was fine, she was in the bedroom getting ready for bed, and her husband followed 15 minutes later and when he got upstairs she was sitting in a chair next to the bed, and he noticed that when he spoke with her that she did not speak clearly back, and was very low tone, not much loudness to her speech. He didn't think much about it, and he talked with her again and noticed that she seemed to be having some difficulty talking, but he could understand what she was saying if he paid close attention. He then realized that something was wrong, and asked her how she felt and she said she felt strange. She was trying to take a pair of socks off and could not reach them. She tried to lift her leg to put one knee over the other for her to remove them and was not able to do that. He helped her take the socks off, she wanted to put some cream on her foot and was not able to do so, which is her usual routine. He put that on her foot while he was talking to her, and her speech was different than it was earlier. She was wearing a turtle neck shirt and was not able to take it off to get dressed for bed. Her husband assisted in dressing her to get ready for bed. He was thinking that she may have been having a mini-stroke. She tried to get up from the chair and was not able to get up on her own. He went to try to help her to lift her and it was hard. When she did get her bottom up off the chair she stayed in a bent position and was not able to stand up. He put her back down on the chair and tried some more times, and ultimately able to get up and he was able to get her into the bed (the chair was next to the bed). She could sit on the edge of the bed, but was not able to move her legs on her own to get into the bed. He struggled to get her in the bed and was not in a mood to talk and just leaned over on one side to try to go to sleep. He told her he was going to get the walker in the basement for her to use. He brought up the walker and put in by the bed, and informed her that it was there, and reached to see where it was in the event that she needed to use it through the night. She did get up around 3:15 this morning to use the bathroom and her husband asked if she needed assistance, and she said that she was able to get up and go to the bathroom, and moved her legs just slow and was able to use the walker. She was feeling much better at that time. She got up one more time during the night and was not in need of the walker and was back to bed. This morning when they got up at 8:00 Am and she was back to her normal self. She came down the steps and was like nothing had ever happened. They called her son who works in the hospital and he told them to call us to see if there were any other people that had the same reaction. She stated while he was giving me this information that she did not recall a lot of the events that he was telling me.
84 2021-03-16 unresponsive to stimuli, feeling hot Within approximately 5 minutes of observation post vaccination, patient suddenly became unresponsive... Read more
Within approximately 5 minutes of observation post vaccination, patient suddenly became unresponsive to questions asked by her granddaughter, no respiratory distress. After 3-4 minutes, she was responsive and alert , oriented to person, place and time. Then after a few more minutes, was unresponsive again with her BP 70s/ 40s HR 48 complaining of abdominal pain and "feeling warm ". She was then transferred to the Emergency Department.
84 2021-03-20 numbness Patient reports headache, body aches and also right arm numbness. Reports that all but the numbness ... Read more
Patient reports headache, body aches and also right arm numbness. Reports that all but the numbness has subsided. Continues to have numbness and tingling in arm where injection was given.
84 2021-03-21 weakness Weakness Shortness of breath Covid-19
84 2021-03-22 weakness For 6 weeks she has had been nauseous, throwing up, -0- energy (like a limp dish rag--hard to sit up... Read more
For 6 weeks she has had been nauseous, throwing up, -0- energy (like a limp dish rag--hard to sit up or hold her head up), severe chills, loss of appetite (lost 20 pounds)
84 2021-03-23 facial pain Sore besides my eyebrows; Jaw joints hurts; Swollen red forehead; Swollen red forehead; Itchy; This ... Read more
Sore besides my eyebrows; Jaw joints hurts; Swollen red forehead; Swollen red forehead; Itchy; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EL8982) on 18Feb2021 17:30 at single dose for COVID-19 immunisation. Medical history included diabetes type 2. Concomitant medications were not reported. Historical vaccine included COVID-19 VACCINE. Patient experienced swollen red forehead and itchy on 19Feb2021, sore besides eyebrows and jaw joints hurts on 20Feb2021. Investigation Assessment was no. Patient reported that she has come up with some peculiar reactions to the Covid thing. She has developed swollen red forehead and that is itchy and it looks like a dog bone across of her forehead. She had second shot on Thursday evening at about 5:30. So, this developed the next afternoon, Friday afternoon, during the afternoon it became a little swollen and a little itchy and then last evening so this is another day later she was sore beside eyebrows and her jaw joints hurt. No treatment was received. The outcome of the events was unknown.
84 2021-03-24 weakness got covid (tested positive); got covid (tested positive); GI issues; weak; This is a spontaneous rep... Read more
got covid (tested positive); got covid (tested positive); GI issues; weak; This is a spontaneous report from a Pfizer sponsored Program. A contactable consumer (patient's daughter) that an 84-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Feb2021 (at the age of 84 years) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller was daughter, her mom (patient) got 1st dose on 04Feb2021, then patient got covid (tested positive) on 23Feb2021, patient had GI (gastrointestinal) issues and weak in Ferb2021. Patient took antiviral treatment and had to be in hospital in 2021. Patient was currently out of hospital, recovered, and in rehab place. Caller was asking for information about 2nd dose past 21 days. Caller was asking if her mother should restart the series. The case was reported as non-serious. Outcome of events was recovered in 2021. Information about batch/lot number has been requested.
84 2021-03-28 feeling cold She developed chills she couldn't control and fell asleep all afternoon, evening and through the nig... Read more
She developed chills she couldn't control and fell asleep all afternoon, evening and through the night. I spoke with her twice and my uncle and aunt checked on her three times, all three she was freezing cold and too tired to get up. In the morning, she was dazed, cold and walked to the bathroom, where she collapsed to her death. Paramedics could not revive her. My mom died Saturday morning - within the 24-hour period of her vaccine. She was feeling so great leading up to it, active, stripping the guest bedroom sheets, bubbly, and excited for us to be able to finally visit her soon.
84 2021-03-29 pain in extremity, weakness Patient received 1st dose Pfizer COVID vaccine on 2/5/2021 and second dose on 2/26/21. She had no a... Read more
Patient received 1st dose Pfizer COVID vaccine on 2/5/2021 and second dose on 2/26/21. She had no adverse reaction to either dose. Around 3/2/2021, she saw her physician complaining of pain in her arm, which was attributed to gout. At the time, she also had a nonproductive cough, generalized weakness and one episode of loose stool. She presented to the emergency room on 3/7/21 with significant hypoxia. She tested positive for COVID 19 by both rapid test and PCR. A quantitative test for COVID antibodies was sent out to a reference lab on 3/7/2021 and resulted on 3/11/2021 as >250 U/mL. Pt. required CPAP, BiPAP, High Flow Oxygen and ultimately intubation. Was not oxygen dependent before hospitalization. Pt. treated with dexamethasone, 2 doses of Remdesivir (then held due to acute kidney injury), tocilizumab X 1 dose, 1 unit COVID-19 convalescent plasma. Pt. expired on 3/19/2021. Sample sent for genome sequencing to check for variants of interest in joint effort between pathology and infectious disease. Report not yet available.
84 2021-03-31 weakness Fever, extreme chills, extreme weakness, hypoexemia, bandemia, hypotension (96/47), tachycardia, (12... Read more
Fever, extreme chills, extreme weakness, hypoexemia, bandemia, hypotension (96/47), tachycardia, (120)
84 2021-04-04 weakness Weakness / Dizziness / Garbled Speech / not feeling well
84 2021-04-04 burning sensation, tingling, pain in extremity A couple days after the vaccine, Hands were sore and burning; felt like needles pricking on top of m... Read more
A couple days after the vaccine, Hands were sore and burning; felt like needles pricking on top of my hands. No swelling and were not red. I had that for about a week. No treatment.
84 2021-04-09 pain in extremity extremely ill; extreme fatigue; nausea; muscle aches; He is afraid she has COVID; have achy arm; Thi... Read more
extremely ill; extreme fatigue; nausea; muscle aches; He is afraid she has COVID; have achy arm; This is a spontaneous report from a contactable consumer (patient reported herself). A 84-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3949, NDC number: Unknown, Expiry Date: May2021) intramuscularly given very high in the top of left arm on 04Feb2021 9:20 AM at 0.3 ml single dose for Covid-19 immunization. The patient's medical history included fractured skull (five years ago), shingles (two years ago) and bleeding ulcers. Concomitant medications were not reported. Patient had the first dose of PFIZER-BIONTECH COVID-19 VACCINE last 04Feb2021 at 9:20 AM - Same day 6:00 PM started to have achy arm - After a few days developed symptoms like extremely ill, extreme fatigue, nausea, muscle aches. DSU potential duplicate AE Report E transmit - According to the patient she had already reported the side effects and transferred to our department. On 04Feb2021, the patient experienced arm started to ache like hell. Tiredness, muscle pain, nausea and feeling horribly ill. It was reported that, "she was having some symptoms. She got her vaccination on the 04Feb2021 and developed the symptoms yesterday. Her doctor was very alarmed that it was not just usual symptoms that go along with the vaccine because of the length of time between when she got it and when she developed symptoms. He was afraid she had COVID. She needed to know if that was normal so she could get back to him. Caller clarified that she meant side effects. She wanted to know whether it was normal to have gotten the vaccine on 04Feb2021 and not develop side effects until 09Feb2021. The vaccination was given in the morning at 9:20 AM and she did not have any symptoms until 6:00 PM that evening. Her arm started to ache like hell. That one showed up then, but cleared up in a couple of days. The arm got better and better. The other set of side effects started yesterday which was tiredness, muscle pain, nausea, and feeling horribly ill. She felt awful and did not want to go to a hospital if it was not necessary. HCP information included she had only seen him a couple of times. She had a long term doctor that retired and she got shifted over to him. They did not have a good relationship she must say. His whole group was associated with where she got the vaccine. They were all virtual now. She had been on lock down for a year. She did not have the doctor's address, phone number, or email. Tiredness, muscle pain, nausea, and feeling horribly ill: started yesterday morning when she got up between 4:30 AM and 5:00 AM. She was so woozy and thought it was left over sleep. She felt unwell all day. She had felt unwell today, but not as bad as yesterday. She had to get vaccination card out of hand bag and needs her glasses to read the small numbers. First dose was given on 04Feb2021. She had appointment on 25Feb2021 for second dose. Healthcare Provider who gave the vaccine was Hospital. They called her on the third at 5:00 PM to see if she could come the next day for the vaccine. They did a good job. Her brother was a retired anesthesiology and she called him this morning and he said to go to the hospital or testing center. Then he agreed that she should call Pfizer. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer suspect were none. She did not get her flu shot in anticipation of getting the COVID vaccine. Her brother and his granddaughter were both anesthesiologist. They get work up about not being able to breathe and ventilators. They gave advice. She was glad her brother approved for her to call Pfizer to find out. She wanted to believe it was side effects. She had been on lock down. Her brother said she could have been exposed at the vaccine site. Caller stated everyone had on a mask. She was not obese. She was not sure if it is relevant, but she would tell it anyway. She fractured her skull 5 years ago and was in Hospital because it was bleeding. That had resolved. She was in ICU and then six weeks of acute rehab. She had a bad case of shingles two years ago which led to bleeding ulcers. Again she went to the hospital, but she was scoped they found ulcers and treated. She went back for scope again and it had all healed up". Outcome of the event have achy arm was recovering whereas other events was unknown.
84 2021-04-09 seizure 3 days after the covid-19 vaccine, she had a seizure and was taken to the hospital. She was diagnose... Read more
3 days after the covid-19 vaccine, she had a seizure and was taken to the hospital. She was diagnosed with sepsis and died 02/22/2021.
84 2021-04-12 pain in extremity, burning sensation, nerve injury Diverticulitis arteries; I had a blood clot after ultra sound; sore arm/Feel sore arms after the fir... Read more
Diverticulitis arteries; I had a blood clot after ultra sound; sore arm/Feel sore arms after the first dose; spinal nerve damage/Spinal nerve pain; Legs are burning hot now; Pain felt in calf and thigh; Bone density test/Ultra sound bad; This is a spontaneous report from a contactable consumer(patient). An 84-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 01Feb2021 11:30 (Batch/Lot Number: EN5318) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:30 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. Medical history included angina from 2002 and ongoing, She says she has angina, and if she would have beating problems can she take a Nitro, cholesterol, depression from 2008 to an unknown date, blood pressure, anxiety from 2018 to an unknown date, arthritis from 1998 and ongoing Illness/AE: Arthritis Onset Date: 1998-2002 Stop Date: Ongoing , hypertension from 2002 and ongoing, blood cholesterol increased from 2002 and ongoing, ongoing urinary tract infection On and off, coronary artery disease from 2005 to an unknown date On and off, Family medical history included Mother coronary artery disease Died on 18Oct1967 and Father 1936 other. Concomitant medications included amlodipine taken for blood pressure abnormal from 2017 to an unspecified stop date; atorvastatin taken for blood cholesterol abnormal from 2002 to an unspecified stop date; bupropion taken for depression from 2008 to an unspecified stop date; buspirone taken for anxiety from 2008 to an unspecified stop date; carvedilol taken for blood pressure abnormal from 2002 to an unspecified stop date, 2x a day carvedilol 12.5. On an unspecified date, the patient experienced diverticulitis arteries, had a blood clot after ultrasound, sore arm/feel sore arms after the first dose, spinal nerve damage/spinal nerve pain, legs are burning hot now, pain felt in calf and thigh, bone density test/ultrasound bad. The patient underwent lab tests and procedures which included blood test: unknown results, computerized tomogram: diverticulitis arteries- On and off, investigation: unknown results. Comments: Going to pain clinic. On always, ultrasound scan: bad on Comments: Ultrasound bad, urine analysis: unknown results on comments: on and off. Treatment received for the events sore arm/feel sore arms after the first dose and spinal nerve damage/spinal nerve pain. Outcome of all events was unknown Follow-up (29Mar2021): This is a follow-up report combining information from duplicate reports 2021138557 and 2021162095. The current and all subsequent information will be reported under manufacturer report number 2021162095.
84 2021-04-14 inability to speak, tremor Patient awoke on the morning of 4/6/2021 with disorientation, confusion and tremors. She presented t... Read more
Patient awoke on the morning of 4/6/2021 with disorientation, confusion and tremors. She presented to the ED for workup, diagnosed with a UTI and discharged home. The patient presented to the ED again on 4/11/2021 with ongoing altered mental status, tremors and anorexia. Family reports no improvement in patient's symptoms since onset (4/6/21). Patient now having difficulty finding words, shakiness on ambulation, hallucinations and tremors. Denies urinary symptoms, repeat urine culture was benign. Patient remains hospitalized as of this report (4/15/21) with fluctuating symptoms, Serial head CTs and lab studies also benign. Unclear etiology of symptoms.
84 2021-04-15 unresponsive to stimuli 3/27/2021- @3 AM resident with increase in SOB with unresponsive episodes. Pt states she has history... Read more
3/27/2021- @3 AM resident with increase in SOB with unresponsive episodes. Pt states she has history of unresponsive episodes related to cardiac issues, declined hospitalization.
84 2021-04-17 difficulty speaking, weakness suffers from asthma but never had the symptoms she's had now; shortness of breath; hoarse/ hoarsenes... Read more
suffers from asthma but never had the symptoms she's had now; shortness of breath; hoarse/ hoarseness; audible wheezing; doesn't have the energy; This is a spontaneous report from a contactable nurse (patient). This 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 10:00 (Batch/Lot Number: EN6208) as 0.3 ml, single for COVID-19 immunization. Medical history included asthma from 2019 and ongoing, when she would sleep her oxygen would drop, and shrunk from 5 feet 5 1/4 inches to now 5 feet 2 inches. She never found out why her oxygen saturations dropped at night but she does not have sleep apnea. Her saturations would drop down to the 80s and she would still be sleeping. Concomitant medications included ongoing albuterol [salbutamol] taken for asthma and oxygen taken for "when she would sleep her oxygen would drop" from 2012 and ongoing. Patient previously took Anoro and Qvar in Aug2019. Patient received the first dose of BNT162B2 on 25Feb2021 (lot number: EN6206, NDC:59267-1000-01, Expiry date unknown) in the left arm. With the first vaccine she did not have any symptoms, she thought she got saline. Only symptoms she felt were when they told her to wait 15 minutes and she sat there and when she got up and she was driving and had her window down her nose felt like it was swelling. She lost her sense of smell due to an injury and she had an acute sense of smell of tobacco from the car next to her. That is the only symptom she had. The acute sense of smell was about 30 minutes after she got her injection, about 5-7 minutes after that. She left about 10:30 am and it happened around 10:35-10:37 am. The acute sense of smell was short lived, it happened for a minute or two. Several years ago she had shoulder surgery and had her great granddaughter and she was playing with her and her foot got caught in the coffee table and she fell and her nose got cut and lost her sense of smell. When asked for seriousness criteria, patient stated it was significant because she had not been able to smell since 2011 and she had the sensation of her nose swelling. She felt like that but she was driving and could not look at her nose. She didn't have the feeling 15 minutes after the vaccine, she had been driving for 5-7 minutes and had the feeling and it was exactly when she got in the car. It was significant because she was able to smell something. Patient had her second dose of the Pfizer Covid-19 vaccine on 18Mar2021 and had shortness of breath. She suffers from asthma but never had the symptoms she's had now. She did not seem to be getting better and the slightest movement, she's short of breath. She is taking the medicine that she normally takes but never had to take it this much. She was short of breath and not paying that much attention to it, when she goes out she wears a mask, since last year, and she went to put the trash out and had shortness of breath stepping out the back door. She was talking to a friend long distance and she told her she was so short of breath. To get out of bed and turn in bed she's more short of breath. The shortness of breath may have started before Friday 26Mar2021 but that's when she noticed it. She would have her mask on, park her car and go to the post office and when she would walk to her PO box, which is the first of the boxes, she was exhausted and not getting enough air and she noticed it. But then when she went outside to put the trash out, just a step outside she was short of breath, that's when she began to notice. She has never been this short of breath and her breathing and exchange of air has never been this bad. She thought she would maybe get her smell back and in all the years she's been diagnosed with asthma she's never had the wheezing and shortness of breath that she's had now. She's never heard herself wheeze. Monday night she was up at 3 am and got up to go to the bathroom and she was so short of breath. She had to take it at 3:30 am and that had never happened to her. She never had wheezing until the second vaccine. She doesn't need a stethoscope to hear the wheezing and that most people have asthma with wheezing but she did not. Patient was not taking the Qvar until after the second dose of the vaccine and was only using the albuterol before. She would take two puffs in her car and then put two masks before getting out. No additional vaccines administered on same date of the Pfizer suspect. No AE required a visit to emergency room or physician office. She was scheduled to see her primary doctor on 13Apr2021 but could not get in earlier and attempted to see her pulmonary doctor and the earliest she can is 07Apr2021 and she has that appointment. Patient was also very hoarse. From time to time medications like her inhaler for her asthma sometimes makes her hoarse. This time she has the hoarseness even when she doesn't take her inhaler. She has audible wheezing. She would not consider the shortness of breath life threatening but it is concerning because she is not able to do what she needs to do because she doesn't have the energy. Hoarseness is worsening because she is taking more of the medications she's normally taking and now she is taking the inhaler twice a day because she is more short of breath. The one inhaler she is using is Qvar. She has been taking the albuterol more also. Hoarseness is not life threatening, it is effective but it is not disabling. The more she talks, the more hoarse she gets. Relatedness of drug to reactions shortness of breath, very hoarse, by primary source reporter (Method of assessment: Global Introspection) was related. Outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Asthma aggravated and Shortness of breath cannot be excluded. Medical history of asthma may provide a plausible alternative explanation for the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
84 2021-04-18 weakness pt says she developed chills and fatigue. She is weak and has a rash around her ears and her neck t... Read more
pt says she developed chills and fatigue. She is weak and has a rash around her ears and her neck that goes down her back. She has itching and redness around the injection site. Her symptoms are getting worse instead of better so she will contact her PCP. She is using Neosporin and alcohol.
84 2021-04-21 pain in extremity On March 27, 2021 two small bruises appeared on her left arm where she had the vaccine injection. T... Read more
On March 27, 2021 two small bruises appeared on her left arm where she had the vaccine injection. The following morning, March 28, 2021, there was a 3x4 square-sized bruise where the 2 small bruises had appeared. The next morning March 29, 2021, the bruise had spread down to her elbow. It was a very dark purple with pain in her arm and swelling where the injection had been administered.
84 2021-04-23 weakness terrible thirst; Fever 100.3; achy pain everywhere; no energy; chills; This is a spontaneous report ... Read more
terrible thirst; Fever 100.3; achy pain everywhere; no energy; chills; This is a spontaneous report received from a contactable consumer (Patient). A 84-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 14:00 as single dose for COVID-19 immunization. Medical history included atrial fibrillation and drug hypersensitivity. The patient's concomitant medications were not reported. On 10Feb2021 at 22:00 patient experienced terrible thirst, fever 100.3, achy pain everywhere, no energy and chills. The patient underwent lab tests and procedures which included body temperature as 100.3 on an unspecified date. Treatment received with aspirin and loads of fluids. The outcome of the events was recovered.
84 2021-04-25 weakness Felt weak 3 minutes after vaccine, vitals wnl.
84 2021-04-30 pain in extremity positive for COVID-19; positive for COVID-19; Left Arm Sore; got sick; head cold; This is a spontane... Read more
positive for COVID-19; positive for COVID-19; Left Arm Sore; got sick; head cold; This is a spontaneous report received from a contactable consumer (reporting on herself). A 84-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734 and Expiration Date was not reported), via an unspecified route in Arm Left on 01Apr2021 11:15 as single dose for COVID-19 immunization. Medical history included food allergy from an unknown date and unknown if ongoing. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received her first dose of the BNT162B2 vaccine on 01Apr2021 and experience Left Arm Sore and reports that several days later, she got sick. She states that on 04Apr2021, she was around people who ended up testing positive for COVID-19 so she herself got tested, but it was inconclusive. She states she figured she was positive because she was around people who tested positive at the same time as she got sick. States they tested on 06Apr2021, and got their results on 08Apr or 09Apr2021. She states on 14Apr2021 she was retested and it came back positive for COVID-19. She states she was supposed to get her second dose on 22Apr2021 and would like to know if she was still okay to continue with that. Patient was concerned with how effective the shot will be if she were to proceed with getting it. She states that she does not feel sick with COVID-19 and reports having a "head cold" but that's it. She would like to know how much time she has to get her second dose of the Pfizer BioNTech COVID-19 vaccine if she received her first dose on 01Apr2021. She requesting guidance on how to reach her vaccina-tion provider for further guidance on possibly rescheduling her second dose of the Pfizer BioNTech COVID-19 vaccine. She states she was not given a phone number but was able to provide the vaccination location's address. Patient did not received any treatment. The outcome for event positive for covid-19, got sick, head cold was unknown and for event left arm sore was recovered on 14Apr2021.
84 2021-05-04 sensory loss Having pain in left shoulder, same site where the Pfizer Covid Vaccination was given; hardly feel ha... Read more
Having pain in left shoulder, same site where the Pfizer Covid Vaccination was given; hardly feel hand; its stiff; can hardly move her shoulder; she can feel it in the muscle; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 31Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported she received the Pfizer Covid Vaccine on 31Mar2021. Patient was having pain in the left shoulder, same site where the vaccination was given. Patient could hardly feel her hand. Stated it goes and comes. 15Apr2021morning when patient woke up it was worse, it was stiff and patient could hardly move her shoulder. She could feel it in the muscle, since receiving the vaccination. Patient stated she needed help and was in pain. Patient asked what should be used for pain. Weight was 168 or 170, in between. Patient stated she wanted to call her doctor before it is too late. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
84 2021-05-05 weakness symtptoms started evening of vaccine dose. Felt fine in am. found on floor by family brought to hos... Read more
symtptoms started evening of vaccine dose. Felt fine in am. found on floor by family brought to hosp by EMS, seizure disorder; didn't have the strength to get to bed due to fatigue, which is history. Also abd pain and diarrhea and myalgias. Mottled reticular rash diagnosis identified: Abdominal pain; Acidemia; Acute kidney injury; Lactic acidosis; Mottled skin; NSTEMI (non-ST elevated myocardial infarction); Right hip pain; Tachypnea; Weakness
84 2021-05-07 pain in extremity Severe muscle stiffness; pain in neck, shoulders, upper back, arms and shoulders; pain in neck, shou... Read more
Severe muscle stiffness; pain in neck, shoulders, upper back, arms and shoulders; pain in neck, shoulders, upper back, arms and shoulders; pain in neck, shoulders, upper back, arms and shoulders; pain in neck, shoulders, upper back, arms and shoulders; affecting my walking; fallen several times; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 11:00 (Batch/Lot Number: EN6201) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included penicillin, sulfa, aspirin, anything related to horse serum, cats and insect bites allergy, fibromyalgia, irritable bowel syndrome and arthritis from an unknown date and unknown if ongoing. The patient previously took BNT162B2 (lot number: EL3247) dose 1 on 26Jan2021 10:45 AM at 84 years old in the left arm for COVID-19 Immunization. The facility where the most recent COVID-19 vaccine was administered was in the urgent care center. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Feb2021, severe muscle stiffness and pain in neck, shoulders, upper back, arms and shoulders the day after the vaccine. This has not abated after two months. The patient stated, "it is significantly affecting my walking, and I am unstable now and have nearly fallen several times. I cannot even move my head to read the paper without pain, and rarely drive anymore as well. I have had fibromyalgia for many years and know that pain well; this is different". The outcome of events was not recovered. The patient resulted in disability or permanent damage. No treatment was given to the patient for the events.
84 2021-05-10 weakness back ache 4 , weakness , low fever
84 2021-05-10 pain in extremity she couldn't put in any exercise up and down/ cannot hold her hand up and it got fall in; she couldn... Read more
she couldn't put in any exercise up and down/ cannot hold her hand up and it got fall in; she couldn't feel any muscle. It is stiff; Left shoulder that is at the site I got the vaccine in pain.; Left shoulder that is at the site I got the vaccine in pain.; I have pain in muscle; I can not hold my hand up and it got fall in.; This is a spontaneous report received from a contactable consumer (patient) and a contactable other health professional. An 84-year-old female patient received second dose of bnt162b2 (Batch/Lot Number: ER8727), via an unspecified route of administration in left arm on 31Mar2021 as single dose for covid-19 immunization. Medical history included high blood pressure and high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included ongoing amlodipine besilate (NORVASC) taken for hypertension; ongoing rosuvastatin taken for high cholesterol. The patient previous took the first dose of bnt162b2 on 10Mar2021 for covid-19 immunization. On 31Mar2021, she had pain in muscle, and she cannot hold her hand up and it got fall in. The muscle pain was so much. She cannot her hand up, she was in so much pain. Left shoulder that was at the site she got the vaccine in pain. She took 1st shot of covid vaccine on 10Mar2021. It is 31Mar2021 for second shot. Lab test: just blood test. She took for her heart and for lymph node. It was Biopsy. It was two weeks ago. She didn't remember the date. She took a nuclear test for her heart. Everything was negative. She got the vaccine in her arm and it wasn't that bad you know until I don't know. In morning she woke up and after the exercise pain in muscle and she couldn't feel any muscle. It is stiff, she couldn't put in any exercise up and down, her muscles she wanted to know what to do with it. She took paracetamol (TYLENOL) in this morning. The patient underwent lab tests and procedures which included biopsy: negative, nuclear test for heart: negative both on an unspecified date. The outcome of events for pain in muscle, Left shoulder that was at the site she got the vaccine in pain were not resolved, for other events was unknown. No follow-up attempts are needed. No further information is expected.
84 2021-05-12 pain in extremity tired from loss of sleep; nose was dripping; acid reflux/ it was worse than before; pretty sick; thr... Read more
tired from loss of sleep; nose was dripping; acid reflux/ it was worse than before; pretty sick; throwing up; loss of sleep; lightheaded and dizzy; She experienced soreness on her arm after the first shot; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 10Mar2021 14:30 (Batch/Lot Number: EL9269) as 1st dose, single for covid-19 immunisation. Medical history included ongoing shingles (but got the shot anyway), ongoing acid reflux (been years and years and years ago, way back in 1990s or so maybe later than that), high blood pressure from 2001 and ongoing, dry eye, macular degeneration, CPO because she was a smoker, 4 bypass surgery, allergic to a blood pressure medicine, blood thinner therapy, and bad sinuses. Concomitant medications included calcium carbonate, magnesium carbonate (TUMS) taken for gastrooesophageal reflux disease, start and stop date were not reported; amlodipine taken for hypertension from 2001 and ongoing; albuterol sulfate taken for ex-tobacco user, pulmonary oedema, start and stop date were not reported; krill oil taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity, start and stop date were not reported; aspirin taken for anticoagulant therapy, start and stop date were not reported; ciclosporin (RESTASIS) taken for dry eye, start and stop date were not reported. She experienced soreness on her arm after the first shot. Patient have acid reflux anyway and it seemed like it come up and it was worse than before, she was pretty sick last night on 15Mar2021 throwing up and still feeling pretty bad today from loss of sleep. Her nose was dripping and her head was all lightheaded, was dizzy and she was sick to her stomach. She sat in her recliner until about 3AM. Patient did not know if this was from the shot or what, but it was terrible. These things were not really ongoing on 16Mar2021, but she feels tired on 16Mar2021 from the loss of sleep on 15Mar2021. She took her antihistamine and her blood pressure pills and she was alright now, just tired from no rest. She reported that she was scheduled for her second dose of the product on 31Mar2021 at 150PM. Patient had blood work done at her last physical on 20Jan2020, and she reports that was all good. Outcome of the events was unknown.
84 2021-05-14 weakness weakness, lightheaded, vomiting and diarrhea, cold, cough, fatigue, congestion or runny nose Imodiu... Read more
weakness, lightheaded, vomiting and diarrhea, cold, cough, fatigue, congestion or runny nose Imodium peppermint tea push fluid Zofran
84 2021-05-14 pain in extremity This is a spontaneous report from a contactable nurse (patient). An 84-year-old female patient recei... Read more
This is a spontaneous report from a contactable nurse (patient). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), via an unspecified route of administration, administered in Deltoid Left on 26Mar2021 as 2nd dose, single for covid-19 immunisation. Medical history included cholesterol abnormal. Concomitant medications included cholesterol medication. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), administered in left arm on 26Feb2021 for COVID-19 Immunization. The patient states she had no immediate side effects. She states that two weeks, after the second dose (in Apr2021), she developed unbearable body aches, specifically in her arms and legs. The patient states she was unable to pick up her right leg and put it over her left leg. She states she is not getting better. The patient is asking if this is a side effect of the Covid vaccine, or is it from something else? She states she was healthy, she walked and was active, before the vaccine. The patient answers as there is very minimal improvement. She states that maybe there is some improvement because she has been taking Ibuprofen and Tylenol. The patient states her event has improved with the medications but they start to come back once the medications wear off. The patient stated she received her Pfizer Covid vaccine first dose in Feb and second dose in march. She stated 2 weeks after the second dose (in Apr2021) she is having terrible muscle aches in her arm and leg (calf muscle) she has to take ibuprofen to get through the day. The patient wanted to know about reports of it. She stated she has seen her doctor and done some tests. She has gone off her cholesterol medication and got checked for clots (no clots). The patient stated, "I got the vaccine in couple of week, I had no problem when I got the vaccine not even a sore arm. couple of weeks later I have developed excruciating pain and aching in my leg and my left arm. I went to the doctor and had whole panel of test and they ruled everything out I don't have Lyme, they took me of my cholesterol medication, I bought a new mattress, I am not sleeping in new mattress. I only take one medication cholesterol medication which I stopped and I am in agony and I wanted to know, if this is possibly connected to the COVID vaccine because I was really really healthy individual before they started." There is no additional Vaccines Administered on Same Date of the Pfizer Suspect, no prior Vaccinations (within 4 weeks), no AE following prior vaccinations, no patient's Medical History (including any illness at time of vaccination). The patient states she feels her medications are not relevant to the report. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events. There is limited information provided in this report. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
84 2021-05-18 tremor she seems to have a cold with a runny nose; full of phlegm; Adds now she seems to have a cold with a... Read more
she seems to have a cold with a runny nose; full of phlegm; Adds now she seems to have a cold with a runny nose; feeling tired/she is tired; extreme chills and freezing; she cut her lip in two places from her teeth chattering; Uncontrollable shaking/worst part was the chills, almost like a seizure'; she had extreme chills and freezing for 3 hours starting when she went to bed.; She started to feel nausea later on Monday; stiff neck on the right side of the back of her neck the day after the vaccine; headachy; Adds hers were like a fast flu; she was so sick she had to get back in bed yesterday; This is a spontaneous report from a contactable consumer (Patient). A 84-year-old female patient re-ceived first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247; Expiration Date: unknown), via an unspecified route of administration, administered in arm left on 21Jan2021 16:00 (at the age of 84-year-old) at a 1st dose, single for COVID-19 immuniza-tion. Medical history included thyroid disorder. No medical history (including any illness at time of vac-cination) was reported. None of the patient family medical history was reported. The patient did not receive any other vaccines prior to the COVID vaccine within 4 weeks. Concomitant medication includ-ed levothyroxine sodium (SYNTHROID) at a dose of 0.88 mg 1x/day (.088 mg; take once daily by mouth) via oral route of administration taken for thyroid disorder. Consumer states she received the Pfizer COVID 19 vaccine 21Jan2021 at 1600PM in the left arm. The effects didn't come until Tuesday night when she went to bed. The patient experienced worst part was the chills, almost like a seizure, headachy, she was so sick she had to get back in bed yesterday, hers were like a fast flu on an unspeci-fied date in Jan2021, she seemed to have a stiff neck on the right side of the back of her neck the day after the vaccine on 21Jan2021, she started to feel nausea later on Monday on 25Jan2021 and she had extreme chills and freezing for 3 hours starting when she went to bed on 26Jan2021. Adds she took two Advil, put on sweats and took a heating pad into bed then she was able to fall asleep. She cut her lip in two places from her teeth chattering and uncontrollable shaking Tuesday night on 26Jan2021. When she put the heavy clothes on and took that Advil the chills stopped, and she slept for four hours. she is tired on 27Jan2021, she seems to have a cold with a runny nose and full of phlegm on 28Jan2021. The patient received Advil as a treatment medication to the events extreme chills and freezing. The events were reported as non-serious. Outcome of the events she seems to have a cold with a runny nose, full of phlegm was not recovered; headachy, adds hers were like a fast flu, she seems to have a cold with a runny nose, worst part was the chills, almost like a seizure, she was so sick she had to get back in bed yesterday was unknown; she started to feel nausea later Monday, she cut her lip in two places from her teeth chattering, feeling tired/she is tired was recovering; stiff neck on the right side of the back of her neck the day after the vaccine was recovered on 25Jan2021, and re-maining other events extreme chills and freezing, she had extreme chills and freezing for 3 hours start-ing when she went to bed, uncontrollable shaking recovered on 26Jan2021. She was asking about getting the second dose considering her chills, Mentioned she talked to a few people who had the chills and were tired after the second dose but they were not as bad and every-thing was over in a day or so. Caller declined to report on anyone she knows who had chills and was tired after the vaccine. Adds she is scheduled to receive the next dose of the vaccine 10Feb2021. Adds it scares her a little bit because of the extreme chills. Follow-up attempts are completed. No further information is expected.
84 2021-05-18 unresponsive to stimuli, weakness 6 weeks after her second Pfizer vaccine, my mom was sitting at the kitchen table after eating breakf... Read more
6 weeks after her second Pfizer vaccine, my mom was sitting at the kitchen table after eating breakfast when she had a syncopal episode (she was unresponsive and lost consciousness for a few minutes). I called 911, and when the paramedics came, her blood pressure was very low and she was sweating heavily. She was very weak and couldn't stand up. She had a similar episode 10 days earlier while having a bowel movement (and also experience diarrhea at that time). She was taken to the ER and was admitted to the hospital for 2 days where testing was done.
84 2021-05-21 feeling cold started itching and itched like crazy all over her body on her shoulders and down her legs, on her b... Read more
started itching and itched like crazy all over her body on her shoulders and down her legs, on her buttocks, and all on her back/a little itch across her back; Felt real chilled and her skin felt like it had little goosebumps/chilled a lot/has been cold and really chillychills sometimes//chilly all over; Felt real chilled and her skin felt like it had little goosebumps/chilled a lot/has been cold and really chillychills sometimes//chilly all over; Felt real chilled and her skin felt like it had little goosebumps/chilled a lot/has been cold and really chillychills sometimes//chilly all over; This is a spontaneous report from a contactable consumer (who reported for herself). A 84-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number EN62W) on 3Mar2021 at 1330 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization, in left arm. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL926F) dose 1 on 10Feb2021 at 1330, as a single dose, for covid-19 immunization, in left arm and experienced Arm was just barely and Back was itching. Medical history included: Lupus (From: 2004 and Ongoing) the creatinine in her urine had gone up; too much calcium in her urine; fasciitis in her foot in January; cortisone shot in her foot on 12Jan2021; on 08Feb2021 she had another cortisone shot in her foot. Concomitant medications included: Vitamin D2 50mg once a week; They took her off of it before she had the Covid injection. On 04Mar2021, the patient started itching and itched like crazy all over her body, felt real chilled and her skin felt like it had little goosebumps. She took Benadryl just about every night, but it makes her so sleepy and puts her to sleep. Her doctor sent her some topical cream, but it took 2 tubes of cream to cover the itchy spot. She used some, but it didn't help her at all. The Benadryl (Diphenhydramine HCl; barcode: 30048284) 25mg was the only thing that stopped it. She took one. She would take one when she would get ready to go to bed. It puts her to sleep real easy. She spoke with his (her doctor) nurse and she explained to him what was happening. She hasn't visited him about this. He prescribed the topical cream Triamcinolone Acetonide ointment USP, 0.1% 15 grams. The clinical outcome of the event pruritis was not recovered; chills, feeling cold, and Goose bumps was recovering. Information on lot/ batch number has been requested.
84 2021-05-24 pain in extremity having difficulty breathing because of her tongue; tongue started burning about 2 hours after receiv... Read more
having difficulty breathing because of her tongue; tongue started burning about 2 hours after receiving the vaccine; tongue as "burning up" and painful; body aches; arm pain; This is a spontaneous report from a contactable consumer (patient's child). An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on 28Jan2021 as first dose, single for an Covid-19 immunization (At the age of 84 years). The patient medical history and concomitant medications were not reported. On 28Jan2021 (yesterday), the patient received the first dose of the Pfizer COVID-19 vaccine, and noticed her tongue started burning about 2 hours after receiving the vaccine. On 28Jan2021, she was also experiencing body aches and arm pain. The patient described her tongue as "burning up" and painful and she was having difficulty breathing (start: 28Jan2021) because of her tongue. The reporter was taking her mother to the hospital now (29Jan2021). The outcome for all the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
84 2021-06-01 pain in extremity back was itching like the small of her back/back just itched; Arm was just barely sore; This is a sp... Read more
back was itching like the small of her back/back just itched; Arm was just barely sore; This is a spontaneous report from a contactable consumer. A 84-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL926F) via an unspecified route of administration in arm left on 10Feb2021 13:30 as first dose, single for COVID-19 immunization. Medical history includes that she was diagnosed with Lupus in 2004 and fasciitis in her foot in January2021. She had cortisone shot in her foot on 12Jan2021 and 08feb2021 within four weeks prior to vaccination. The patient previously took vitamin d2 + calcium [calcium gluconate; calcium phosphate; ergocalciferol] 50mg once a week, cortisone for fasciitis on Oct2020 patient has taken flu shot and a booster for pneumococcal pneumonia however in past patient took flu shot and had flu. No adverse event prior vaccination. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN62W) via an unspecified route of administration in Arm Left on 03Mar2021 13:30 as second dose, single dose for COVID-19 immunization. On 10Feb2021 had first dose in her arm was barely sore. She did not feel sick or anything. About the second night (12Feb2021) after the first dose of the vaccine they were watching TV and she was sitting on the couch and noticed the small of her back was itching. It was just a little bit, and she did not pay attention because now and then she will have a little itch and did not notice it. She is calling back with questions about the same thing. Confirms that there are no new events. Since her first dose of the covid vaccine, on the second day after, that night, before she got in her bath, her back was itching. She did not pay it much attention. After her second dose of the covid vaccine, on the third day, she took her clothes off to take a shower and she had no rash, but she had chill bumps like she was cold. She read all of the information on side effects on the report. She saw where it said she could have chills. She had no problems with the injection or her arm being sore. She had no nausea, or no other symptoms that they talked about. Her skin felt like she had chills bumps from her knees to her shoulders. This has continued since. She does not have a reference number for her first report. She does not know when it went away/ over next day or 2. She told the person when got the shot that she had Lupus and asked if there was any reason, she should not get this. The nurse talked to somebody and came back and said no it would not affect it. It probably has not. She just wonders if there is something in the injection. She feels like that what caused her to itch since she has not changed her medications at all. The only thing which she came off this before she took the injection, was her rheumatologist advised all of her patients to take Vitamin D2 because of Covid. She was on that and was having some problems, the creatinine in her urine had gone up. They took her off it before she had the Covid injection. The patient underwent lab tests and procedures which included blood creatinine increased: increased on, blood calcium: increased. The outcome of the events was unknown. Description of complaint: While reporting an AE for Covid Shot caller mentioned that she has taken Benadryl for itching and it would calm it but she still has itching now. It makes her so sleepy and puts her to sleep. It says Diphenhydramine HCl 25mg. She sees a number where there is a barcode: 30048284, Lot: Not provided, not probed on call. She can't read an expiration date on it. She also has an old bottle. There is a barcode on it too: 312547 17031 4, Lot/Expiry date: Not provided, not probed on call. She also mentioned her doctor sent her some topical cream, but it took 2 tubes of cream to cover the itchy spot. She used some, but it did not help her at all. The topical cream she was given was Triamcinolone Acetonide ointment. It says USP, 0.1 percent. It is 15 grams. NDC: 0168-0006-15. Lots/Expiry: She does not see any other numbers or expiration date. She also mentioned years ago she took the flu vaccine and then a few days later ended up with the flu. She has no NDC, lot, or expiration date for the flu shot she had prior to getting the flu. She also mentioned that She had a cortisone shot in her foot on 12Jan2021. On 08Feb2021 she had another cortisone shot in her foot for continued fasciitis. Cortisone shots: She has no NDC, lot, or expiration date available, they just gave it in the office. No follow-up attempts are needed. No further information is expected.
84 2021-06-03 tenderness First dose: The day after receiving the first dose experiencing these lumps down the front of the ar... Read more
First dose: The day after receiving the first dose experiencing these lumps down the front of the arm; The lumps going down it and they are tender; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route, administered in left arm on 30Apr2021 as single dose for Covid-19 immunisation. The patient's medical history included ongoing atrial fibrillation (Afib) which was diagnosed five years ago and memory problems. No prior vaccinations (within 4 weeks). Concomitant medications were not reported. The day after receiving the first dose experiencing these lumps down the front of the arm on 01May2021. The lumps are all of them, all the way down the arm. The lumps are very tender, touchy and haven't gone away in 2021. It was the left arm after the first dose. The outcome of events was not recovered. Information on the lot/batch number has been requested
84 2021-06-04 tenderness Now its got the lumps going down it and they are tender; Now they are going down the other arm/lumps... Read more
Now its got the lumps going down it and they are tender; Now they are going down the other arm/lumps on her arms; Now its got the lumps going down it and they are tender; Now they are going down the other arm/lumps on her arms; caller asks does Pfizer have options to get rid of the swelling; This is a spontaneous report from a contactable consumer, the patient. An 84-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 mRNA VACCINE BIONTECH), dose 2 via an unspecified route of administration, administered in Arm Right on 21May2021 (Batch/Lot Number: EW0161) (at the age of 84-year-old) as 2nd dose, single dose for covid-19 immunisation. Medical history included ongoing Afib (diagnosed with Afib five years ago) and memory problems. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (Pfizer BioNTech Covid 19 mRNA VACCINE BIONTECH), dose 1 administered in Arm left on 30Apr2021 (Batch/Lot Number: EW0158) for covid-19 immunisation and had lumps down the front of the arm. The patient did not receive any other vaccines within four weeks prior to the vaccination. No additional vaccines administered on same date of the Pfizer suspect. On 22May2021, the patient reported now it got the lumps going down it and they are tender. The patient went ahead and received the second dose Pfizer Covid 19 Vaccine and now its got the lumps going down it and they are tender. They are not really going down, still there. Wondering if there was some kind of anecdote to take care of it? The right arm was not as serious. The marks or lumps are sort of in the same places on both arms, like in the bend of the arm in the elbow. The patient doesn't know anyone else having this problem. Are these lumps on the caller's arms lymph nodes? The caller states she has been concerned about the lumps on her arms but not concerned enough to go to the doctor. The patient stated she has not talked to anyone at her primary care physician's office yet. The patient did not visited to emergency room or physician office. It was suggested the patient go to have the lumps looked at but the patient never did. The patient asked does Pfizer have options to get rid of the swelling, to treat it? Oh, Pfizer doesn't have anything for that, the patient was giving Pfizer a chance to treat it. No relevant tests done. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.
84 2021-06-07 pain in extremity Sore arm; Received the entire vial of the undiluted Pfizer COVID vaccine; Received the entire vial o... Read more
Sore arm; Received the entire vial of the undiluted Pfizer COVID vaccine; Received the entire vial of the undiluted Pfizer COVID vaccine; This is a spontaneous report from a contactable nurse. This nurse reported same event for two patients. This is the second of the two reports. An 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0168, Expiration Date: Aug2021; 84-year age at time of vaccination) via intramuscular route administered in the right deltoid on 12May2021 at 09:38 (at the age of 84-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included diabetes mellitus from 14Sep2017 and ongoing, dialysis and end stage renal disease from 18Sep2017 and ongoing, and cardiac disorder from 22Jul2017 and ongoing; ESRD from 18-SEP-2017 ongoing; Heart Disease from 22-JUL-2017 ongoing. The patient's family history and concomitant medications included none. The patient previously received first dose of BNT162B2 (Lot ER8736, Expiration Jul2021) administered intramuscularly in right deltoid on 21Apr2021 at 9:29 for COVID-19 immunisation. No other history of prior vaccinations. The nurse reported a medication error for two patients who received the entire vial of the undiluted Pfizer COVID vaccine on 12May2021. The reporter did not provide specific signs and symptoms. They were in their care after the vaccine was given for an hour and sent home. They were instructed for any signs and symptoms to report to ER immediately. Neither patient was experiencing any symptoms at the time. Upon follow-up on 02Jun2021, it was reported patient had sore arm on 12May2021 17:30; Reported seriousness criteria non serious, not received Treatment. The outcome of the event sore arm was recovered on unspecified date in May2021, and the outcome of other events was unknown. Follow up (02Jun2021): This follow up-spontaneous report received from a contactable other HCP in response to HCP letter (sent) via follow-up letter which included that: New AE details (sore arm); Relevant Medical History (ESRD, heart disease, diabetes). Follow-up attempts were closed and completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021537945 same reporter/product/event, different patient.
84 2021-06-10 pain in extremity She reported having injection site swelling; the second shot hurt her; her arm was swore 2-3 days/ar... Read more
She reported having injection site swelling; the second shot hurt her; her arm was swore 2-3 days/arm a little sore after second shot; and was tired after; right hand swollen/Her index finger on the left hand is swollen back to the palm; right ankle swollen/swollen down to her wrist; thumb swollen and stiff; left index finger swollen/thumb swollen/her middle finger swelled; This is a spontaneous report from a contactable consumer or other non healthcare professional. An 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in left arm on 30Apr2021 at 15:00 (Batch/Lot Number: ER8735) (at the age of 84 years) as 2nd dose, single dose for COVID-19 immunization. Medical history included arthritis, patient's mother had arthritis but she had it much younger than patient's age. Concomitant medication(s) included ubidecarenone (COQ 10) 100mg, once a day for health reasons and ongoing, acetylsalicylic acid (ASPIRIN (E.C.) 81 mg, once a day for heart and ongoing, losartan (LOSARTAN) for cardiac disorder and ongoing (Had been taking over 10 years), carvedilol (CARVEDILOL) for cardiac disorder and ongoing (Had been taking over 10 years). Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm 02Apr2021 (at the age of 84 years) as single dose for COVID-19 immunization. On 14May2021, patient experienced, left index finger swollen/thumb swollen/middle finger swelled. She went to the doctor on 14May2021, when she showed the doctor her finger they said it could possibly be arthritis. On an unspecified date, patient experienced injection site swelling, the second shot hurt her, her arm was sore 2-3 days/arm a little sore after second shot, was tired after, right hand swollen/her index finger on the left hand is swollen back to the palm, patient had to take her rings off, it hadn't gotten as bad as the index finger but it was swollen, it was not as stiff to bend as the index finger, it was hard to bend and was stiff when she got up right ankle swollen/ swollen down to her wrist, thumb swollen and stiff. She thought that the doctor said to take Tylenol as treatment, but she didn't care for Tylenol, so she didn't take anything. The outcome of the left index finger swollen/thumb swollen/middle finger swelled was not recovered while for the events was unknown. No follow-up attempts are possible. No further information is expected.
84 2021-06-16 pain in extremity Feels very sick; She has fever; pain in her kidney and legs; pain in her kidney and legs; This is a ... Read more
Feels very sick; She has fever; pain in her kidney and legs; pain in her kidney and legs; This is a spontaneous report from a contactable consumer or other non hcp. An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and expiry date was not reported) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient's concomitant medications were not reported. On an unspecified date, caller withheld, feels very sick after getting the first dose. She wanted to know what to do. She has fever and was experiencing pain in her kidney and legs. She had COVID before but wanted to know if the side effects will go away and how long will it last. Advised to transfer her to PMI but it was closed already. The outcome of all the events was unknown. Information about lot/batch number has been requested.
84 2021-06-17 tremor the teeth chattering only occurs when she puts her teeth together, its like she is freezing; chin tr... Read more
the teeth chattering only occurs when she puts her teeth together, its like she is freezing; chin trembling/chin is jumping up and down; This is a spontaneous report from a contactable consumer. This consumer reported for a 84-year-old female patient (sister) that: Patient characteristics: Age at time of onset of reaction/event: 84 Age at time of onset of reaction/event (Unit): Year Weight (kg): 61.23 Reaction(s)/Event(s): Reaction/event as reported by primary source: Teeth chattering Reaction/event in MedDRA terminology (LLT): Teeth chattering Reaction/event MedDRA term (PT): Chills Date of start of reaction/event: 03Feb2021 Outcome of reaction/event at the time of last observation: NOT RECOVERED/NOT RESOLVED Drug(s) Information: Characterization of drug role: (SUSPECT) Proprietary medicinal product name: COVID-19 Vaccine Batch/lot number: Unknown Dosage text: first dose, intramuscular injection Date of start of drug: 02Feb2021 Action(s) taken with drug: Unknown Narrative case summary and further information: Case narrative: Selected Report Type: Initial Is the patient also the reporter? No Reporter type: Consumer or other non health professional Primary / Prescribing Healthcare Professional Info Dates for Teeth chattering: (From: 03Feb2021 To: Ongoing) Is COVID-19 Vaccine a Pfizer product? Unspecified COVID-19 Vaccine manufacturer: Unspecified Dates for COVID-19 Vaccine: (Start: 02Feb2021 Stop: Unspecified) NDC number of COVID-19 Vaccine: Unknown Reason for no lot number: of COVID-19 Vaccine: Other: Caller does not have her sister's vaccine record card Expiry Date of COVID-19 Vaccine: Unknown Other Products: No Patient History: No Investigation Assessment: No Additional Context: Caller states she is calling on behalf of her sister, (Name). They received the first shot of the Pfizer COVID-19 Vaccine. The caller states they were all doing really well except her sister woke up and when she puts her teeth together, her teeth are chattering. Her chin trembles really fast. Caller wants to know have there been any other reports of this occurring? Height: 5'6'' or 5'7'' Caller declined to include a healthcare professional. Caller states the teeth chattering only occurs when she puts her teeth together, its like she is freezing. Her chin is jumping up and down. VACCINE SUPPLEMENTAL FORM Patient Details- Last name: (Last name) First: (First name) Address: (Address) (City name), (State name) (Postal Code) Telephone number: doesn't have one Pfizer Suspect Vaccine and Vaccination Details Vaccine Lot Number: Unknown Vaccine Lot Expire Date: Unknown Time the Vaccination Was Given: 12:30pm Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left arm Vaccination Facility Type: (Vaccination Facility Name) in (Vaccination Facility City), (Vaccination Facility State) For US Only: Vaccine Administered at Military Facility? No Vaccination Facility Address: Unknown, she knows its on (Vaccination Facility Address) in (Vaccination Facility City), (Vaccination Facility State). History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available); n/a; this was the patient's first dose Additional Vaccines Administered on Same Date of the Pfizer Suspect: None Adverse Event (AE) Details: Teeth chattering/chin trembling Time of onset: about 8am Additional Information Did any AE(s) require a visit to: Emergency Room? No Physician Office? No Prior Vaccinations (within 4 weeks): None AE(s) following prior vaccinations Patient's Medical History (including any illness at time of vaccination): None Relevant Tests: None Information on the Lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
84 2021-06-22 discomfort Around 4/19/21 pt started experiencing shortness of breath that increased to the point of gasping fo... Read more
Around 4/19/21 pt started experiencing shortness of breath that increased to the point of gasping for breath on 4/25/21. Her daughter (me!) visited and immediately called her pulmonologist who requested she immediately go to the hospital. The ER said she had an enlarged heart, and was checked in to the cardiac unit. Tests showed she had acute systolic and diastolic heart failure. She was first put on diuretics while further tests were done, and Tikosyn was later added to her list of regular medications. Within a week she was able to go home. She was on oxygen prior to this event from the pulmonary fibrosis, and was able to return to her prior settings on her oxygen concentrator within five days, but her ongoing discomfort has stayed at a heightened level, and her level of activity has not returned to her normal. Please note: she is an 84 year old with pulmonary fibrosis. It is not possible for me as her daughter (not a medical professional) to know if the original diagnosis of heart inflammation was related to her vaccination, but she had been relatively stable for more than six months prior to this hospitalization event and the onset of this sequence of events was identified by the doctors as being of unknown origin at that time.
84 2021-06-23 weakness ischemic stroke; infection; progressive weakness; poor appetite; hardly being able to walk; dehydrat... Read more
ischemic stroke; infection; progressive weakness; poor appetite; hardly being able to walk; dehydrated; mild elevated liver enzymes and WBC count; mild elevated liver enzymes and WBC count; SOB; possible lung infection; some lesions on her liver; a small mass in her lung,which they said were suspicious for cancer; a small mass in her lung,which they said were suspicious for cancer; This is a spontaneous report from a contactable nurse. A non-pregnant 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 13Apr2021 (at the age of 84-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension (HTN), hyperlipidaemia (HLD), type II diabetes mellitus (DM2). Concomitant medications included regular prescribed medications for HTN, HLD, DM2 (drugs unspecified). No other vaccines prior to four weeks. Known allergies were unknown. No COVID prior to vaccination. Covid test post vaccination in May2021 was negative. The patient had no acute issues prior to her 1st COVID vaccine. In Apr2021, the started experiencing progressive weakness and poor appetite to the point of hardly being able to walk. The patient saw her primary doctor who ran some blood work and noticed she was dehydrated with mild elevated liver enzymes and WBC count. The patient was admitted to the hospital (for 21 days) for IV fluids and was on oral antibiotics. The patient started having some SOB and scans done indicated possible lung infection. The patient was switched to IV meropenem which did not help. The doctors also noted some lesions on her liver and a small mass in her lung (no biopsy was done cause she declined) which they said were suspicious for cancer. The patient then suffered a large ischemic stroke and she passed about a week later. The patient was feeling well before her vaccine and everything started to go downhill after her vaccine. AEs result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent covid test: negative in May2021. The outcome of events weakness, decreased appetite, unable to walk, dehydration, elevated liver enzymes, white blood cell count increased, short of breath, lung infection, hepatic lesion, lung mass, and lung cancer was unknown. The patient died on 27May2021 due to ischemic stroke and infection. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported suspicion on malignancy and BNT162B2 use is unrelated while the causal relationship between the remaining events and the use of BNT162B2 cannot be fully excluded. There is limited information available which precludes a more meaningful assessment. However, the underlying conditions and the age of the patient maybe risk factors. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: ischemic stroke; infection
84 2021-06-24 weakness cough, difficulty breathing, productive cough, 02 requirement, weakness resulting in hospitalization... Read more
cough, difficulty breathing, productive cough, 02 requirement, weakness resulting in hospitalization and death. received treatment : Azithromycin and Decadron 02/09/2021-02/19/2020
84 2021-06-27 seizure like phenomena Death SAH (subarachnoid hemorrhage) Observed seizure-like activity Hypo-osmolality and hyponatremi... Read more
Death SAH (subarachnoid hemorrhage) Observed seizure-like activity Hypo-osmolality and hyponatremia Acute kidney failure, unspecified Thrombocytopenia, unspecified
84 2021-06-28 brain damage Phone visito Visit History for 3/12/2021 Problem List* Health Maintenance* Results/Data* Review Flo... Read more
Phone visito Visit History for 3/12/2021 Problem List* Health Maintenance* Results/Data* Review Flowsheets* History of Present Illness HPI: 84 yo female pmh: DJD right hip, CAD and chronic anticoagulation was contacted via telephone: states she received her covid 19 vaccine 3 days ago: now having dry (non productive cough)-denied any fever/chills or loss of smell/taste. o Visit History for 3/12/2021 Problem List* Health Maintenance* Results/Data* Review Flowsheets* History of Present Illness HPI: 84 yo female pmh: DJD right hip, CAD and chronic anticoagulation was contacted via telephone: states she received her covid 19 vaccine 3 days ago: now having dry (non productive cough)-denied any fever/chills or loss Issues Addressed/ Plan Diagnosis Plan 1. Viral upper respiratory tract infection (s/p covid 19 vaccine) predniSONE 20 MG Oral tablet albuterol (PROVENTIL HFA) 90 mcg/actuation Inhl inhaler (afebrile) Counseled on supportive measures Has declined covid 19 test Informed: if conditions worsens: present to ED (immediatetly) 3/25 pt's son in the room, updated and answered all questions at this time. 4/2 Pt's husband also inpatient and covid+. Spoke with daughter today and updated r/t quarantine. 2. Nursing Education/Concerns: Care team met with family (husband, son and daughter) on 3/18/21 to discuss care goals/plan of care moving forward. Pt's code status officially updated to DNR only with trial intubation. 3/18/2021 spoke updated pts daughter on phone at 1031. Report given to SNF- they were made aware that she needs the second pfizer vaccine 3. Interdisciplinary involvement Social Work/Case Management: From home with spouse. STR- Referral out. STR reviewing. Will not take patient before her 10 day exposure quarantine is over. 4/9. STR- Bed offer for tomorrow pending insurance auth and negative COVID. sent for auth. Patient aware. Son updated. COVID exposure - exposure to covid positive visitor on 3/26 and 3/29 - discussed with infection control. Will test on 3/31 and if negative will test again on 4/7 (day 9 of quarantine) unless symptoms develop in interm. Acute hypoxic respiratory failure secondary to acute on chronic systolic LV failure requiring prolonged ventilation and SNF placement after discharge. Encephalopathy, dysphagia, anemia, tachy, AKI
84 2021-06-30 weakness, difficulty speaking This is a spontaneous report from a contactable consumer, the patient. An 84-year-old non-pregnant f... Read more
This is a spontaneous report from a contactable consumer, the patient. An 84-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route administration in right arm on 10Mar2021 at 12:00 (at the age of 84-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. It was unknown the patient allergic to food medication or other product. It was unknown the patient received any other vaccine within 4 weeks prior to the covid-19. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 the patient experienced flu-like symptoms, hoarse voice, weakness, hard to walk. The patient received vaccine on 10Mar2021 and still had some of the symptoms today, that is on 23Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures and treatments were not taken for the reported events. The clinical outcome of the events experienced flu-like symptoms, hoarse voice, weakness, hard to walk were not resolved (still have symptoms today i.e., 23Mar2021) at the time of reporting. Information on lot/batch number has been requested.
84 2021-06-30 seizure Within 30 days patient experienced a seizure - this patient has no history of seizure
84 2021-07-06 slurring I am the epidemiologist reporting on behalf of patient. Patient received two doses of Pfizer on 01/... Read more
I am the epidemiologist reporting on behalf of patient. Patient received two doses of Pfizer on 01/09/21 and 02/02/21. Case was admitted to hospital on 6/26 due to slurred speech, low heartrate, and low oxygen (75%) and tested positive for COVID-19 via a PCR test. The patient passed away on 07/01/21. Cause of death is listed as sepsis. Death cert # 20210042573.
84 2021-07-23 numbness chest pain; her arm went numb; she experienced deep pain above her knees on both sides; the knees, b... Read more
chest pain; her arm went numb; she experienced deep pain above her knees on both sides; the knees, because of clotting or whatever so she tried to rub some alcohol on her leg; This is a spontaneous report from a contactable Other Health Professional (patient, Dentist). A 84-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EW0167), via an unspecified route of administration at left arm on 26APR2021 at the 84 years old at single dose for COVID-19 immunization. The medical history was ongoing high blood pressure, pain and allergic. The concomitant medications were none. The patient states she goes to the doctor for a checkup for almost 1 year but she cant go because she wasn't able to go anymore because of corona virus and she didn't go out to visit her doctor for almost one year. The patient states she has high blood pressure, but she doesn't have medicine, it was diagnosed a long time ago because the doctor said take this medicine but she wasn't able to get a checkup and wasn't able to get the medicine so she doesn't have medicine. The patient would like to report a terrible effect on herself by the Pfizer vaccine. The patient states she had her first vaccine 26APR2021 and after that she had chest pain on 27APR2021 that lasted for the next day and almost 2 days and then her arm was also numb on 27APR2021 and she just put some hot and cold compress on her chest and she just rested and it just went away, but last week the same thing, her chest became painful and she saw this number about the Covid 19 and that's why she's calling, what should she do should she get the second vaccine? The patient states she did not report to anybody yet, this is her first time. The patient states last week, it came back again and then on the next day 27APR2021, it was very deep and painful in her knees, both sides, left and right above her knees. The patient states yes, sometimes its very painful. The patient states not now, but last week the pain was in her chest and she put a cold compress on it. The patient states after the numb and pain, its not like pain, its deep pain, that's why she's bothered. The patient states it's really serious, the knees, because of clotting or whatever so she tried to rub some alcohol on her leg, that's what she did. Chest Pain; very deep and painful in her knees: The patient states it's slowly not pain, it's not very painful like before, the first and second time that it occurred. The patient states it's pain, but it's like better, it's getting better. The patient states she cannot say that it's recovered, she feels a little better. The patient confirms it is ongoing and it is persisting. The patient states it's not worsening, she just feels it sometimes then it goes away if she massage it or applies pain ointment.Chest Pain: The patient states her chest is painful, the left side of her chest is very painful. The patient states she doesn't like to receive it because she said she might be allergic because sometimes she's really allergic, but all her friends said she needs to go now, she will be protected and of course she knows that like from the flu vaccine so she searched before she was able to see and she was going to get Moderna so she said she would look for a nearer place near her and so her friend told her to go to pharmacy because she has friends there that would help her and she went there and she got the Pfizer vaccine. The patient states that's because she did not have the pain before that for a long time for many years and now after getting the vaccine, now, she experienced it. All of the events were assessed as Medically significant. The adverse events did not require a visit to Emergency Room or Physician Office.Prior Vaccinations (within 4 weeks), there was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The reporter considered the events were all related to Pfizer Covid 19 Vaccine. The outcome of the event was Numbness of upper extremities was not recovered ,the others was Recovering. The information on the batch number has been requested.; Sender's Comments: Based on the information provided and temporal association, a causal association between suspect drug and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
84 2021-07-26 weakness 7/23/21: came to the ED with generalized weakness and cough with low oxygen levels with hx of COPD. ... Read more
7/23/21: came to the ED with generalized weakness and cough with low oxygen levels with hx of COPD. admitted with COVID-19 pneumonia, acute renal failure, hypoxemia Note: patient previously vaccinated with Pfizer COVID-19 vaccine on: 1/26/2021 and 2/23/2021. Lot numbers EL1283 and EL9269 7/27/21: patient still admitted at the time of this report submission.
85 2021-01-05 unresponsive to stimuli Patient did not display any obvious signs or symptoms; the vaccination was administered at approxima... Read more
Patient did not display any obvious signs or symptoms; the vaccination was administered at approximately 10:00 AM and the patient continued throughout her day without any complaints or signs of adverse reaction. Patient was helped to bed by the nursing assistant estimated at around 9:00 PM. The facility received notification from the lab around 11:00 PM that the patient's COVID-19 specimen collection from Sunday, 1/3/21, detected COVID-19. When the nursing staff went to the room to check on the resident and prepare her to move to a COVID-19 care area the patient was found unresponsive, no movement, no chest rises, noted regurgitated small amount of food to mouth left side, lying on left side. Pupils non reactive.
85 2021-01-06 pain in extremity Confirmed DVT in the left leg; COVID test (PCR swab): positive on 26Dec2020; COVID test (PCR swab): ... Read more
Confirmed DVT in the left leg; COVID test (PCR swab): positive on 26Dec2020; COVID test (PCR swab): positive on 26Dec2020; This is a spontaneous report from a contactable other healthcare professional. An 85-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELO140, expiration date: Mar2021), via an unspecified route of administration in arm (deltoid; unknown side) on 23Dec2020 at single dose for Covid-19 immunisation. Medical history included type 2 diabetes mellitus from 2017 and ongoing, high blood pressure from 2017 and ongoing, atrial fibrillation (A-Fib) from 2019 and ongoing. The patient's concomitant medications were not reported. The patient was administered first dose of the COVID vaccine on 23Dec2020 and then was swabbed for COVID on 26Dec2020, and then on 28Dec2020 her PCR swab was positive for COVID. She was asymptomatic until she started complaining of leg pain. She ordered an ultrasound for the patient on 30Dec2020, and it confirmed a deep vein thrombosis (DVT) in left leg. The patient was being treated with anticoagulant apixaban (ELIQUIS) currently. Caller stated that this could be that it (DVT) is from COVID, but her real question was, could it be from the vaccine? In Pfizer's information packet for patients, there is section on what to tell your provider prior to getting vaccinated. One of the things on there is if you have a bleeding disorder or are on an anticoagulant. There is no explanation as to why it was in the packet of information. Caller has looked everywhere and can not figure out why that is on the FAQ/packet information. The patient was due for the second dose on 13Jan2020, but she was worried and hesitant to approve it. The patient underwent lab tests and procedures which included COVID test (PCR swab): positive on 26Dec2020, ultrasound of the left leg: confirmed DVT on 30Dec2020. The outcome of events was not recovered.; Sender's Comments: There is not a reasonable possibility that event "COVID test (PCR swab): positive" is related to BNT162B2 vaccine. The event occurred 3 days after vaccination, when vaccine was not expected to achieve the effect. The event DVT of legs is not considered related to BNT162B2 vaccine. The patient had underlying diabetes and cardiovascular disorders, which are considered as risk factors for DVT. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
85 2021-01-12 weakness ON 1/11/21 DEVELOPED DIZZINESS, CHILLS, AND WEAKNESS. WAS SEEN IN URGENT CARE ON 1/12/21
85 2021-01-19 difficulty speaking patient was complaining of 'hoarseness of throat'. This was approximately 20 minutes after the admi... Read more
patient was complaining of 'hoarseness of throat'. This was approximately 20 minutes after the administration of vaccine. Patient taken to ER when she arrived to ER patient stating her throat was itchy.
85 2021-01-21 flushing Patient received that vaccine at 1130 at 1142 patient noted she was having a flush feeling her her f... Read more
Patient received that vaccine at 1130 at 1142 patient noted she was having a flush feeling her her face, tingling in her tongue. No noted swelling to lips, tongue, face, no breathing events. Patient was administered Benadryl 50mg IM and was brought for continuous monitoring in our clinic. She noticed relief in flushing within 2 mins of injection and tongue tingling within 5 minutes. It was approximately 30 minutes after Benadryl injection she had improvement with her lip tingling. Patient was monitored in total in clinic for 1 hour prior to be discharged home, no other administration of medications needed. All symptoms resolved prior to discharge by provider.
85 2021-01-21 seizure I had a seizure in the early morning 2 days later. I have had seizures for several years and am on ... Read more
I had a seizure in the early morning 2 days later. I have had seizures for several years and am on anti seizure medication (Vimpat) but have not had any for at least a year. I recovered quickly and am fine now.
85 2021-01-27 pain in extremity Sore arm lasting 48 hours after vaccination
85 2021-01-30 tingling At 1146, RRT was called at the post-vaccination monitoring area for an 85 y/o female that was experi... Read more
At 1146, RRT was called at the post-vaccination monitoring area for an 85 y/o female that was experiencing tingling throughout left arm after administration of the Pfizer vaccine at 1132. No other symptoms reported. Client?s car was off and she was accompanied by her neighbor, who was seated on the passenger seat. Client was the driver at the time. 2 RRT nurses responded to the scene with the E-kit and stethoscope. Head-to-toe assessment done, all WNL. Client speaking clearly, able to extend both arms, face symmetrical. Bilateral arms and legs have equal strength. Initial HR: 65, BP: 117/70, RR: 20, denies pain. Client?s arm tingling did not get worse or better. 911 assistance not needed at this time. Client recommended to be monitored for an additional 10 minutes by Recovery Nurse. Client was encouraged to have neighbor drive her home, which she consented. After additional 10-minute monitoring period, left arm remained the same and client did not experience any other symptoms. Neighbor moved to the driver?s seat and client is now in the passenger seat. Client advised to speak to her PCP about incident and if SOB and/or life-threatening problems occur, to call 911 or get to the nearest hospital/ER. Client and neighbor verbalized understanding. All questions answered, all concerns met. Client left premises, her neighbor driving, via car @ 1210. Client exited with head-to-toe assessment WNL.
85 2021-01-31 weakness Pt. was vaccinated and being monitored, 15 minutes after vaccination. Pt was injected @ the R DT. Pt... Read more
Pt. was vaccinated and being monitored, 15 minutes after vaccination. Pt was injected @ the R DT. Pt reported pain to R side of neck, dizziness, and weakness. Pt's vitals were obtained all were WNLs, breathing was normal and unlabored. S/S subsided, pt denied any further issues. Pt was released to spouse.
85 2021-01-31 cold sweat, weakness, feeling cold 3:45 pm Patient c/o feeling dizzy at 3:45 pm. Daughter and son in law present and requested water. P... Read more
3:45 pm Patient c/o feeling dizzy at 3:45 pm. Daughter and son in law present and requested water. Patient took a few sips of water and soon after became cool and clammy. Patient became incoherent and was not responding to myself or her daughter. Became lethargic and couldn't hold her head up. Diaphoretic and skin remained cool and clammy. Client is not diabetic. Patient is on meds for B/P and did have cardiac bypass surgery 2 years ago. Daughter and I decided to call an ambulance. B/P 80/40 (L) and rechecked 5 min later and was 90/50. No SOB or trouble breathing. Lung sounds were clear and WNL. No respiratory distress noted. O2 sat 94%. Pulse 55. Ambulance arrived and took over care. Patient did get transferred to ER via ambulance per the daughter's request
85 2021-01-31 feeling cold Height: she shrunk; aching in shoulders and uppers arms; aching in shoulders and uppers arms; her wh... Read more
Height: she shrunk; aching in shoulders and uppers arms; aching in shoulders and uppers arms; her whole body has felt colder; She does not feel good; She has been pretty depressed with the pain; crying; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3248), intramuscular in upper left arm on 13Jan2021 13:15 at single dose for covid-19 immunisation (prevent covid). There was no medical history. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She got the flu shot and shingles shot way before the covid vaccine. The patient got her Pfizer covid vaccine last Wednesday on 13Jan2021. She had been aching in her shoulders and upper arms hurting real bad on 14Jan2021. She had some chills. She did not feel good and it did not seem to be letting up. The first day she was fine. She clarified that she did not experience chills, she felt colder on her whole body on 14Jan2021. She took ibuprofen (ADVIL) about 2.5 to 3 hours ago earlier as treatment. Height: she shrunk. She still had a good appetite. She had been pretty depressed with the pain, she was hurting and crying from the pain. No emergency room or physician office visit required. She was scheduled to get her second dose at the same facility. The outcome of events aching in her shoulders and upper arms hurting real bad, felt colder on her whole body was not recovered. The outcome of other events was unknown.
85 2021-02-01 seizure Seizure - onset approximately 1 hour after vaccination administration. No medical history of seizure... Read more
Seizure - onset approximately 1 hour after vaccination administration. No medical history of seizures. Duration estimated 3 min - myoclonic head jerking, eyes rolled back, cyanosis
85 2021-02-02 weakness patient received vaccine on Jan 23, 2021. developed weakness on Jan 25, 2021. Sent to ED on Jan 27, ... Read more
patient received vaccine on Jan 23, 2021. developed weakness on Jan 25, 2021. Sent to ED on Jan 27, 2021 with hypoxia requiring 6 L O2, low Bp, declining mental status. Per family request transitioned to hospice and passed away on Jan 30, 2021
85 2021-02-02 pain in extremity Painful left arm, unable to move, no swelling or redness. Chills and body aches first 12 hours, arm... Read more
Painful left arm, unable to move, no swelling or redness. Chills and body aches first 12 hours, arm pain continues with no ability to move.
85 2021-02-04 pain in extremity, facial pain hurting/right arm and shoulder over to the left; hurts on both sides/right shoulder right above on t... Read more
hurting/right arm and shoulder over to the left; hurts on both sides/right shoulder right above on the neck began to ache; hurting/right arm and shoulder over to the left; hurts on both sides/right shoulder right above on the neck began to ache; pain went across her face to the left side; pain in the right shoulder to above the neck; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration in the right deltoid on 14Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were none. The patient informed that the hurting started when she was just talking with someone on 17Jan2021. The patient had taken ibuprofen and tramadol. The patient informed that her right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides and wanted to know if there was anything she could do to eliminate that or make it less consuming. The patient informed that she didn't notice any problems for a couple days, then her right shoulder right above on the neck began to ache. This pain went across her face to the left side, it has sort of stayed in this particular area. It has not stopped aching since then. The patient informed that she didn't know what to take. The patient informed that the pain in the right shoulder to above the neck started 3 days after, it went on to the face to left side, it was in the neck mostly, and the top part of the shoulder, it was a dull aching pain, sometimes it shrills, and she really felt like, it was like it really hits her. The neck shoulder pain all started on the same day. The patient informed that it was not quite as bad as before, she took ibuprofen. The patient took Tramadol after the onset of the neck/shoulder pain. The patient informed that the end of the second phase of the vaccine is coming on the 07Feb2021. The outcome of the events pain in arm, facial pain was unknown, while shoulder pain, neck pain was recovering. Follow-up activities are possible, information on the batch number has been requested.
85 2021-02-07 weakness feeling slightly weak; feeling unwell; felt as if she is getting the flu or in the beginning stages ... Read more
feeling slightly weak; feeling unwell; felt as if she is getting the flu or in the beginning stages of the flu; tired; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3247), via an unspecified route of administration on 21Jan2021 20:00 at single dose for COVID-19 immunization. The patient's medical history included uses a walker on a regular basis for spinal stenosis. Concomitant medications were not reported. Patient received first dose of Pfizer COVID vaccine on 21Jan2021 around 8pm, at the vaccination site she was tired and was given a chocolate chip cookie and felt better. On 22Jan2021 morning she was feeling slightly weak nothing violent she is just feeling unwell. She generally feels weak, but said this is hard to explain. She felt as if she is getting the flu or in the beginning stages of the flu. Patient does not have a fever. Generally doesn't get reactions to the flu shot or pneumonia shot, that is very minor. The outcome of tired was recovering, of other events was unknown. Patient would like to know if her symptoms are to be expected after receiving the first dose of the vaccine and how long will her symptoms last, what to do about her symptoms.
85 2021-02-07 coordination abnormal, facial paralysis, slurring Sudden slurring of speech slight mouth droopiness; Sudden slurring of speech slight mouth droopiness... Read more
Sudden slurring of speech slight mouth droopiness; Sudden slurring of speech slight mouth droopiness; Sudden loss of consciousness; difficulty in bringing her hand to mouth to eat-opposite arm from injection site / Difficulty walking, getting out of bed; Increasing confusion, soreness, pain, throughout as well as injection site; Increasing confusion, soreness, pain, throughout as well as injection site; Increasing confusion, soreness, pain, throughout as well as injection site; Difficulty walking, getting out of bed.; Severe lethargy, tiredness, sleepiness; Severe lethargy, tiredness, sleepiness; Severe lethargy, tiredness, sleepiness; This is a spontaneous report from a contactable other HCP. An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EK9231) intramuscular in left arm on 19Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included beginning signs of dementia, stage II breast cancer not immune compromised, no chemo no radiation only hormone therapy, and hormone therapy. There was no known allergies. The patient was not pregnant. There were other unspecified medications in two weeks. After 3-4 hours after injection on 19Jan2021 19:30 she had difficulty in bringing her hand to mouth to eat-opposite arm from injection site. Increasing confusion, soreness, pain, throughout as well as injection site. Difficulty walking, getting out of bed. Severe lethargy, tiredness, sleepiness. Day 3 after vaccine on 22Jan2021, all other symptoms still present and worsening, then sudden slurring of speech slight mouth droopiness, then sudden loss of consciousness. Could not be woke up for about 15 minutes then opened eyes but not aware of surroundings. Taken to hospital for work up. On day 4 after vaccine still confused not at normal baseline. Needs assistance in walking, eating, etc. Events resulted in: Emergency room/department or urgent care, Hospitalization for 7 days, Disability or permanent damage. The patient received treatment such as ER and ongoing hospital stay with Pt and OT for events. She received COVID test via nasal swab on 22Jan2021 with result of negative. Events outcome of difficulty in bringing her hand to mouth to eat-opposite arm from injection site, increasing confusion, soreness, pain, throughout as well as injection site, difficulty walking/getting out of bed, severe lethargy, tiredness, sleepiness was not recovered, while for others was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
85 2021-02-08 unresponsive to stimuli Xrays showed covid Poss pockets all in her lungs on 15Jan; Xrays showed covid Poss pockets all in he... Read more
Xrays showed covid Poss pockets all in her lungs on 15Jan; Xrays showed covid Poss pockets all in her lungs on 15Jan; This is a spontaneous report from a contactable consumer. An 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included dementia. Concomitant medications were not reported. Patient popped hot 02Jan2021 along with 4 others on the hall she lived. Within 9 days 50+ patients were positive. All had the vaccine the same day. Patient was test positive on 02Jan2021. She was on day 12 of her quarantine when she started to get worse. She was unresponsive by 16Jan2021 and passed 18Jan2021. We were with her from 14Jan2021 to 18Jan2021. But had not been allowed to visit with her since Mar2020. And what post treatment pairs well with it? Publicly we hear Remdesivir and Bamlanivimab but these patients only received a general antibiotic and some vitamins. Death cause was Xrays showed covid Poss pockets all in her lungs on 15Jan2021. No autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information; Reported Cause(s) of Death: Xrays showed covid Poss pockets all in her lungs on 15Jan
85 2021-02-09 facial paralysis, bell's palsy, difficulty speaking 2/1/21 2:30pm Pt c/o tongue numb, difficulty speaking. Noted facial drooping & reddened watery Lt ey... Read more
2/1/21 2:30pm Pt c/o tongue numb, difficulty speaking. Noted facial drooping & reddened watery Lt eye. Emergency room diagnosed Pt with shingles/Bells Palsy.
85 2021-02-09 flushing, numbness Pt reported dizziness, flushing, numbness in both hands to patient monitor. This RN assessed pt, who... Read more
Pt reported dizziness, flushing, numbness in both hands to patient monitor. This RN assessed pt, who also reported chest pain, described as "angina" but said she had not had this type of chest pain before. Said she takes nitro for other chest pain but that pain is sharp and stabbing. Pain today described as "dull" and on left side of chest. Also reported nausea. VS: BP 130/82, HR 86, SpO2 98%. EMS called due to chest pain. While waiting for EMS, patient reported that pain started radiating from chest around to left back. No SOB, talking in full sentences with RN and son. EMS arrived and brought patient to ambulance. Pt was not transported to ED, returned to car to go home (son driving). .
85 2021-02-09 flushing, tingling Tingling, numbness of lips, sensation of swelling in left side of throat without difficulty swallowi... Read more
Tingling, numbness of lips, sensation of swelling in left side of throat without difficulty swallowing,, elevated BP, no shortness of breath, O2, P wnl. Benadryl 25 mg PO given and tolerated, flushing of face and still sensation of lt throat swelling, called EMS to transport to ED
85 2021-02-15 muscle spasms Nausea, Throwing up, Chills, fever, Happened on days 1-5 after vaccine. Diarehia, cramps..painful ... Read more
Nausea, Throwing up, Chills, fever, Happened on days 1-5 after vaccine. Diarehia, cramps..painful to rib cage & Pelvis, Bone pain, cannot walk, loss of appetite & loss of balance I feel now!
85 2021-02-18 feeling of body temperature change, muscle spasms 2pm, chills, alternating hot/cold, feverish, fatigue, leg cramps. Sleep, rest.
85 2021-02-19 pain in extremity This was the second shot, given on February 5, 21 days after the first one,. I was totally bedri... Read more
This was the second shot, given on February 5, 21 days after the first one,. I was totally bedridden for several days, getting up only for necessities I lived on Ibuprofen. I would get up, take two Ibuprofen, and sit for an hour before I could func. My arm hurt. The worst part is that my brain felt as if it were all swelled up, pushing against my skull. I could not perform normal tasks at all , until the last couple of days. I could not think, reason or remember at all until the last 2-3 days, I had to get substitutes to teach my classes. I could not write nor communicate nor pay my bills. I have a manuscript overdue. I am now staying at night with friends, for neither they nor I trust me to function normally alone.
85 2021-02-21 tingling Patient reports lower lip feels tingly and puffy, denies other symptoms. Given Benadryl 25 mg PO per... Read more
Patient reports lower lip feels tingly and puffy, denies other symptoms. Given Benadryl 25 mg PO per MD. Approx 20 min later reports feet feel tingly, provider ordered another dose of Benadryl 25 mg PO. Symptoms subsided and MD cleared for discharge. Friend will drive patient home.
85 2021-02-23 feeling cold, tremor, feeling hot I got the vaccine at 8 AM that morning and I was fine until about 5PM and I got very cold. I was fre... Read more
I got the vaccine at 8 AM that morning and I was fine until about 5PM and I got very cold. I was freezing. I had a chill. I checked my temperature and it was around 99-100. During the night I woke up with a bad chill, I was really cold and I was shaking really bad. I checked my temperature and it was 102. Tuesday I checked my temperature all day it never went over 102. I took Ibuprofen all the day, no more then 4 tablets. I took a nap in the afternoon for about 2 hours and I when I woke up I was really cold and I was freezing and shaking. I was so cold my teeth were chattering. My mouth was very dry, I tried to drank a sip of water, which made me nauseous and I throw up slightly. My husband was concerned because he couldn't get me warm and he called our son. Our son came over, and asked do I know who he is and I responded no. I have reconciliation of my son coming over or my husband calling our son over to come check on me. My son immediately to called 911, EMS arrived and they transported me to hospital. I do not remember any of this, I didn't become appear until I was stretcher , at that point I became aware and knew the answers to the questions being asked but I couldn't respond. I remember hearing the EMT say to turn the air on, I was burning up and had a temperature of 105. I was transported to Medical Center. They run a lot of tests and they were trying to get my fever down. Sometime late that night they were finally able to my temperature down. I was released about 10 AM on Wednesday morning. I have been fine since then. The doctors who all seen me in the ER all said they have not seen anything like this.
85 2021-02-24 pain in extremity left arm swelling, appeared within one hour of second vaccine dose. Swelling progressed with sorenes... Read more
left arm swelling, appeared within one hour of second vaccine dose. Swelling progressed with soreness of arm. Swelling worse day after. Started abating by Thursday 2/25/21 evening. Advised ice pack on arm, but pt. said it was too sore on day after dose given (Wednesday) to apply. Pt. took one aspirin on Wednesday morning. Advised her she could take a second later in the day. (Yesterday pt. stated she had taken a Tylenol. Today upon review she realized that she took an aspirin. Ibuprofen is also available. Advised pt. take an ibuprofen now over the phone as I waited. Taken at 8:13pm EST. No further medication taken on Wednesday. (Also encouraged ice pack on neck Wednesday for ongoing strong headache / neck pain yesterday. Pt. does not remember if she tried that. Head/neck pain resolved today.) Pt. states swelling today (Thursday) is mild-to-moderate, less than yesterday, but still noticeable. Doesn't hurt as much as it did yesterday, she says. She can now lift her arm without pain.
85 2021-02-24 pain in extremity "Patient with a PMH of HTN, Afib RVR (on Eliquis), nonischemic CMO, HFrEF (EF 25%), HLD, HLD, Fe def... Read more
"Patient with a PMH of HTN, Afib RVR (on Eliquis), nonischemic CMO, HFrEF (EF 25%), HLD, HLD, Fe deficiency anemia, Pulmonary HTN, rectus sheath hematoma presented to ED with LUE edema and pain that started a couple of hours after second dose of COVID vaccine adminstration. Patient had received COVID vaccine shortly after noon day prior to admit on RUE. She reports that she had been experiencing some nausea as well. She was admitted to the hospital for overnight observation secondary to transient alteration of awareness after she presented to the ED for arm swelling where experienced a syncopal episode lasting approximately 1 minute. She was monitored on cardiac tele which showed Afib with appropriate rate control overnight. For her left upper extremity swelling an U/S was done which was negative for thrombus, only a hematoma. Her arm pain was controlled and supportive with a compress. Patient had no further syncope, Afib rate controlled, and hemodynamically stable. Discharged home 2/24/21.
85 2021-02-25 tingling Lower lip angioedema within 15min of injection. Dose of benadryl given. Tingling in feet/hands 15min... Read more
Lower lip angioedema within 15min of injection. Dose of benadryl given. Tingling in feet/hands 15min later, resolution of lip symptoms. 3 days later recurrence of the angioedema, treated with benadryl
85 2021-03-03 pain in extremity sore arm; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female ... Read more
sore arm; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient asked if she can get the second dose of the Pfizer covid-19 vaccine while taking tofacitinib citrate (XELJANZ). She forgot to ask for the first dose and she already got it. She received the first dose of the Pfizer covid-19 vaccine and experiencing a sore arm that lasted a couple of days. The patient recovered from sore arm on an unspecified date. Information on the lot/batch number has been requested.
85 2021-03-03 pain in extremity a little bit of arm pain/Her arm was a little amount sore; This is a spontaneous report from a conta... Read more
a little bit of arm pain/Her arm was a little amount sore; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262), via an unspecified route of administration on 01Feb2021 09:45 at a single dose for COVID-19 immunization. Medical history included ongoing Splenic marginal cell non-Hodgkin's Lymphoma of the B cells and spleen; infection in her bursae sack in her knee and she was in the hospital for that; she also had three infections. There were no concomitant medications. The patient reported that the shot was so simple, and she hates shots. It was the Pfizer shot given by a nurse at the clinic. Before bed on 01Feb2021, she thought her arm was starting to hurt so she took a pain pill. She doesn't think she needed it. She got the vaccine at 09:45 in the morning of 01Feb2021. She thought she had arm pain, but she didn't really ever get it. She didn't experience pain or anything otherwise. She also stated that she had a little bit of arm pain, her arm was a little amount sore. But it went away by the next day on 02Feb2021. It was very minor. She didn't feel like it was worth reporting. She felt it once in a while if she moves her arm but is not enough to mention. She hates shots, and this one wasn't as bad as half of the other shots she has had. She has no complaint about it. The outcome of the event was recovered on 02Feb2021.
85 2021-03-06 pain in extremity Post injection Day 1, merely lethargic & painful arm. Day 2, absolutely PERFECT. Day 3, low-grade fe... Read more
Post injection Day 1, merely lethargic & painful arm. Day 2, absolutely PERFECT. Day 3, low-grade fever, uncomfortable arm but never inspected Day 4 (today): Noticed redness on arm, reaching 4-1/2 inches in length below site of injection, warm to the touch. Low grade fever of 98.1 when normal is in the 97.1 area.
85 2021-03-09 weakness Weakness, headache, pancytopenia 89
85 2021-03-09 unresponsive to stimuli Patient found unresponsive approx 16 hours after vaccination. Death listed as Cardiac arrest second... Read more
Patient found unresponsive approx 16 hours after vaccination. Death listed as Cardiac arrest secondary to stenosis. Patient had inoperable cardiac issues and was reportedly in a terminal state.
85 2021-03-11 inability to speak Mini Stroke. Could not talk for 2 minutes then jumbled sentences. next day tired but improved. Follo... Read more
Mini Stroke. Could not talk for 2 minutes then jumbled sentences. next day tired but improved. Following day just tired. No long term symptoms
85 2021-03-11 pain in extremity Extremely swollen at the site of injection. She knew something wasn't right immediately after inject... Read more
Extremely swollen at the site of injection. She knew something wasn't right immediately after injection. A little white dot appeared where needle was inserted. Arm swelled. Initially thought it was common. But was not getting better and was painful and made her not feel well. She went to the doctors thankfully a few days after and was advised that it was infected. Could have been dangerous for her if infection continued to move through her body. She is now on antibiotics. This is strange to have an infection which makes us feel the needle was not properly sterilized? Something foreign entered at the time of that shot and we would like to have answers. The doctors could not even identify why this happened. Company Pfizer..
85 2021-03-11 unresponsive to stimuli 2nd injection given on 02/16/2021 Altered Mental Status admission on 3/3/2021 Intracranial bleedin... Read more
2nd injection given on 02/16/2021 Altered Mental Status admission on 3/3/2021 Intracranial bleeding Unresponsive Intracranial bleed Death on 3/6/2021
85 2021-03-13 unresponsive to stimuli Serious drop in glucose level causing lethargic, non responsive and unsteadiness which lasted for se... Read more
Serious drop in glucose level causing lethargic, non responsive and unsteadiness which lasted for several days. Same thing happened after the 2nd does. But glucose dropped to 25, which caused a visited to the ED.
85 2021-03-14 feeling hot developed a rash; very itchy; She said she had the feeling of needles all over her entire body and f... Read more
developed a rash; very itchy; She said she had the feeling of needles all over her entire body and face, along with a hot feeling; her neck, chest, and upper back are a purple-red color; difficulty seeing; macular degeneration; This is a spontaneous report from a contactable consumer (patient herself). An 85-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot# EN9581), via an unspecified route of administration on 20Feb2021 09:15 (at the age of 85-years-old) in right arm at single dose for covid-19 immunisation. Patient had allergies and asthma for years. There were no concomitant medications. Patient reported she got her first COVID-19 Vaccine on Saturday, 20Feb2021. She said she developed a rash on Monday (22Feb2021), and was very itchy. She said she didn't have the rash on her legs. She said she had the feeling of needles all over her entire body and face, along with a hot feeling on 22Feb2021. She said she was contributing her rash to the COVID-19 Vaccine. She asked if she got the second COVID-19 Vaccine, would the rash occur again, and would the rash be worse. The caller said she was scheduled to receive her second COVID-19 Vaccine dose on Thursday, 11Mar2021. The caller was advised she would be transferred to Pfizer Medical Information for further assistance. She had macular degeneration and had difficulty seeing in Feb2021. She clarified she felt like her face had needles going through it. She said her neck, chest, and upper back are a purple-red color on 22Feb2021. She said she was so uncomfortable that it was hard for her to wear clothes, and she had to sleep in the nude. Treatment: she was taking diphenhydramine hydrochloride (BENADRYL) and her daughter gave her an over-the-counter cortisone cream in a tube to use for her rash. She said she just started using the cortisone cream today (25Feb2021). She said she did not have the Benadryl and cortisone cream tube with her to provide the UPC/NDC Numbers, Lot Numbers, and Expiration Dates. She planned to call her doctor to see if he will give her something for the rash once she was finished speaking with Pfizer. The events did not require emergency room or physician office. Outcome of macular degeneration and difficulty seeing was unknown, and outcome of other events were not recovered.
85 2021-03-14 pain in extremity Several minutes after vaccine patient complained of dizziness and "feel funny". Also complained of ... Read more
Several minutes after vaccine patient complained of dizziness and "feel funny". Also complained of "legs feel weak". Stated she usually does not have issues after vaccines/shots. States left arm "hurts" but had vaccine in right arm. She has history of cardiac stents.
85 2021-03-17 weakness fainted; passed out and was unconscious; still kind of feel weak; bruise on both knees; fall; This i... Read more
fainted; passed out and was unconscious; still kind of feel weak; bruise on both knees; fall; This is a spontaneous report from a contactable registered nurse (patient, Retired RN). An 85-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982) at single dose via an unknown route injection in left arm on 23Jan2021 around 08:15 for Covid-19 immunization. Medical history included ongoing blood pressure high which was controlled with medication, allergic to penicillin and acetylsalicylic acid;ascorbic acid (ASPIRIN). She had lost weight and shrunk according to when she went to the doctor 2 months ago. No other products were taken. No history of all previous immunization with the Pfizer vaccine considered as suspect; no vaccines administered on same date with the Pfizer vaccine considered as suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine, no events following prior vaccinations. No family medical history relevant to the events. Patient passed out on her way home on 23Jan2021 (unknown time). The event required a visit to Emergency room, but not a Physician office. The event clinical course was as follows: She got the first dose of the Covid-19 vaccine on Saturday 23Jan2021. Patient reported that after being monitored at the vaccination site for 20minutes, she left to go catch the bus and fainted before boarding the bus. She remembered getting on the bus, but did not remember crossing the street. She passed out and was unconscious. An ambulance was called and they took her back to the hospital where she got the vaccine. She was taken by ambulance back to the ER, stayed for half the day, she received IV fluids, and a brain scan due to her fall. She stated that she still feels kind of weak as of 29Jan2021. She did not know what time it happened, because she lost her sense of time on that day because she did not remember. When she got to the hospital she woke up and wondered where she was because she did not remember what happened. They got an x-ray of her head to see if she had bumped it, but it was negative. She did have a bruise on both knees. They gave her IV fluids, and kept her there for a little while, then sent her home. She called her doctor the next day, but he was busy, so she talked to the nurse. No treatment was recommended, just said to get a lot of rest. She was scheduled for the 2nd dose on 13Feb2021 and was scared to death. Patient verified that she was not admitted to the hospital. Investigation assessment were performed. They hooked her up to the monitor, did an x-ray and a CT scan while at the hospital on 23Jan2021 which were normal (both fine), and gave her IV fluids. Outcome of fainted, fall, passed out and was unconscious was resolved on 23Jan2021. Outcome of kind of feel weak was not resolved. Outcome of the other event was unknown.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of fainted and unconscious cannot be fully excluded. The underlying history of high blood pressure for this 85 years old patient might provide an alternative explanation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
85 2021-03-17 difficulty speaking hoarse voice; felt like she had a big lump in her throat; difficulty swallowing; Allergic reaction; ... Read more
hoarse voice; felt like she had a big lump in her throat; difficulty swallowing; Allergic reaction; This is a spontaneous report from a contactable consumer (patient's daughter) received via Medical Information Team. An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 04Feb2021 (at the age of 85 years) at single dose for COVID-19 immunisation. The patient medical history included allergic to different medications. The patient's concomitant medications were not reported. It was reported that on 04Feb2021, the patient an hour after the vaccine developed a hoarse voice and two hours later felt like she had a big lump in her throat and had difficulty swallowing, their healthcare provider said he didn't believe it was an allergic reaction and was leaving it up to her if she wants to get it or not. The reporter stated her mother is allergic to different medications and those allergic reactions started the same way this did. The patient outcome of the events was unknown.
85 2021-03-17 tingling, electric shock sensation 2/14/21-Immediately after 1st covid vaccine experienced pressure sensation in chest and breast. Gre... Read more
2/14/21-Immediately after 1st covid vaccine experienced pressure sensation in chest and breast. Great on the right side, went up to the back to neck. The shock sensation went over the top of the head onto face with tingling bilateral. Resolved on 3/3/21. 3/3/21- Severe vertigo-hospitalized for 3 days. On day 1 of vertigo sudden hearing loss.
85 2021-03-20 tingling Patient complained of tingling in her fingers. No other symptoms, denied HA, dizziness or lightheade... Read more
Patient complained of tingling in her fingers. No other symptoms, denied HA, dizziness or lightheadedness. Denied tingling in arms or anywhere else. MD aware. Patient stayed under observation for 60 minutes. BP 158/61 then 170/89 and then 161/86, then 146/52. Pulse ox was 99-100 entire time. Hear rate ranged 49-52 Also gave patient cookies and water. She felt improved when she left.
85 2021-03-21 discomfort hard of hearing; Headache and then I had muscle aches/Achy and headachy; Headache and then I had mus... Read more
hard of hearing; Headache and then I had muscle aches/Achy and headachy; Headache and then I had muscle aches/Achy and headachy; Little bit of discomfort; Kind of stiff; Trouble in seeing; Used to be 5'7" but now I am 5'4"; she noticed bright red bleeding in her urine when she emptied her bladder; I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it; Skin dry; slept a lot; she felt tired and so rotten; mild low-grade fever; body aches and pains; This is a spontaneous report from a contactable consumer (patient herself). An 85-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810) via an unspecified route of administration on 25Feb2021, 11:00 am as a single dose for COVID-19 immunisation. Medical history included hypertension, stroke, heart attack, COVID-19 in Aug2020 (actually had COVID this summer in August, had the mild case), and emergency surgery in Aug2020. Concomitant medications included ajmaline (CARDIA), isosorbide, and levothyroxine sodium (SYNTHROID) taken for cardiac disorder; and losartan. The patient her first dose on 04Feb2021 and experienced headaches, muscle aches and pains, chills, other flu-like symptoms, heart conditions, and sensitivity to eggs. She mentioned that this was normal and nothing unusual. She received her second dose on 25Feb2021 at 11:00 am. She was still kind of stiff but was okay. The next day on 26Feb2021 at 11:00 am, she noticed bright red bleeding in her urine when she emptied her bladder. After a few hours it faded. On the next day on 27Feb2021, she experienced the bright red bleeding in the urine again. The red blood did not hurt and patient was achy and headachy, "you know muscles." So, that kind of happened and it just kind of eased off. She slept a lot because she felt tired and so rotten from Friday, Saturday, Sunday after getting the shot. She also had a mild low-grade fever, headaches, and body aches and pains which she considered normal. Patient was hard of hearing and did not have a bright red bleeding, just had a taint little bit till the day when she got it and then the next day, she went to the bathroom to empty her bladder again and had bright red bleeding again with some blood clots in it. Then she did not really have that much the rest of the day and since then it seems to be clear. She did have a little bit of discomfort and her skin was dry. She have never had that experience before so she was just not sure was that connected with that shot? She wanted to know if there were any other patients that have had that. Patient also stated, "I have a bit trouble in seeing. So, I am going to have my magnifying glass" when asked about the product details. She will be getting her annual check up on 24Mar2021 so she will also check with her doctor. She mentions that she doesn't take that much flu-shots because she is sensitive to eggs. Her urine seems to be clear as of the time of report. She wants to know if the bright red bleeding in the urine has been reported. Patient stated, "I used to be 5'7" but now I am 5'4". I think I am weighing about 158 now. I am sorry like I said because of my hearing and with a language difference a little bit. I was having a trouble hearing you." The patient did not have treatment for the events. Outcome of the events was unknown.
85 2021-03-22 numbness Got numb on right side of body and A-fib flared up. Went to hospital and was discharge with no issu... Read more
Got numb on right side of body and A-fib flared up. Went to hospital and was discharge with no issues.
85 2021-03-23 weakness Extreme Exhaustion followng day - could not left head from pillow - did not eat for 3 days - appitie... Read more
Extreme Exhaustion followng day - could not left head from pillow - did not eat for 3 days - appitiete has returned - But am left with deep fatigue for over 2 weeks - Friday, March 26th will be 3 weeks - leg still week - fatigue - is this normal what can I do - Too weak to drive to see doctor - Last week he said - do what you can and take Tylenol - First dose same reaction for 2 weeks - but was fine for second dose - Now I am going into 3 weeks with fatigue. Is this normal - I did have the virus in April - had antibodies but did not have this reaction after. Please will this cease? Acknowledge ASAP
85 2021-03-23 pain in extremity 1st vaccine on 2/18. Developed rash bilateral lower extremities. Underwent work-up for suspected vas... Read more
1st vaccine on 2/18. Developed rash bilateral lower extremities. Underwent work-up for suspected vasculitis. Had lower extremity pain limiting ambulation and contributing to fall. Required hospital admission on 3/1 for ongoing work-up and treatment of vasculitis. Also found to have right Achilles tendon rupture. Discharged to skilled nursing facility on 3/6. 2nd vaccine on 3/11. Presented to ER on 3/13 with dyspnea and acute hypoxic respiratory failure due to diffuse alveolar hemorrhage/pulmonary edema requiring intubation on 3/17. Extubated 3/21 and transitioned to hospice care.
85 2021-03-25 weakness hospitalization day after vaccine. fever/vomiting/diarrhea/weakness/dizziness
85 2021-03-25 flushing, numbness Patient monitored for reaction as recommended per ACIP guidelines after vaccine administration. Pt r... Read more
Patient monitored for reaction as recommended per ACIP guidelines after vaccine administration. Pt reported dizziness, flushing, numbness in both hands to patient monitor. This RN assessed pt, who also reported chest pain, described as "angina" but said she had not had this type of chest pain before. Said she takes nitro for other chest pain but that pain is sharp and stabbing. Pain today described as "dull" and on left side of chest. Also reported nausea. VS: BP 130/82, HR 86, SpO2 98%. EMS called due to chest pain. While waiting for EMS, patient reported that pain started radiating from chest around to left back. No SOB, talking in full sentences with RN and son. EMS arrived and brought patient to ambulance. Pt was not transported to ED, returned to car to go home (son driving). Electronically Signed by RN on 02/10/21, 1707
85 2021-03-28 feeling cold Approx. 02/04/2021 Pfizer Vaccine dose # 1 Started feeling cold all the time soon after which contin... Read more
Approx. 02/04/2021 Pfizer Vaccine dose # 1 Started feeling cold all the time soon after which continues. Not feeling well in general which still continues. Very high fever and skin on face turned dark and red on left cheek like sunburned and dried up and then skin started flaking off. Heart rate remained normal which is in upper 50?s and 60?s. 02/25/2021 Pfizer Vaccine dose # 2 02/26/2021 57 BPM Heart Rate BP 155/69 03/01/2021 65 BPM Heart Rate BP 146/70 03/03/2021 59 BPM Heart Rate BP 155/67 03/04/2021 59 BPM Heart Rate BP 151/77 03/06/2021 59 BPM Heart Rate BP 145/68 03/10/2021 54 BPM Heart Rate BP 174/77 03/11/2021 80 BPM Heart Rate BP 151/79 03/12/2021 104 BPM Heart Rate BP 146/102 108 BPM Heart Rate BP 152/118 03/13/2021 114 BPM Heart Rate BP 125/72 Trouble breathing 03/14/2021 131 BPM Heart Rate BP 113/82 03/15/2021 129 BPM Heart Rate BP 155/111 03/26/2021 - 03/27/2021 can?t catch her breath and nearly lost consciousness several times Still feeling cold all the time and still not feeling well in general. Heart rate remains dangerously high and in atrial fibrillation
85 2021-03-30 bell's palsy Stroke and Bell's Palsy
85 2021-03-30 muscle spasms Very tired; Nauseous; Slight cramp in left thigh or leg; Tiredness and feeling unwell; This is a spo... Read more
Very tired; Nauseous; Slight cramp in left thigh or leg; Tiredness and feeling unwell; This is a spontaneous report from a contactable consumer. A 85-years-old female patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration, administered in left arm on 29Jan2021 as single dose for prophylaxis, COVID-19 immunization. the patient does not received other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported but other relevant medical history including but not limited to these conditions: Diagnosed allergies, compromised immune status, Respiratory illness, Genetic Chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity from unknown. The concomitant medications were not reported. On 04Feb2021 08:00 patient experienced (at the age 0f 86-years-old time of onset reaction or event occurred) very tired (fatigue), nauseous (nausea), slight cramp in left thigh or leg (muscle spams) and tiredness and feeling unwell (malaise). Received call from consumer regarding the Pfizer COVID vaccine. She was called on behalf of someone else. They received their first vaccination on 29Jan2021, and on page 3, she was reading the side effects. Patient reports being very tired today. She also felt nauseous and had a cramp in her leg that disappeared almost as quick as it came. The outcome of the events was recovering. Information on the Lot/batch number has been requested.
85 2021-04-06 weakness The day after receiving the second dose, pt became so weak that she couldn?t get out of bed. Also c... Read more
The day after receiving the second dose, pt became so weak that she couldn?t get out of bed. Also complained of chest pain (has CAD with angina).
85 2021-04-07 weakness tested positive for covid; body aches; not feeling well; weakness; low grade fever; This is a sponta... Read more
tested positive for covid; body aches; not feeling well; weakness; low grade fever; This is a spontaneous report received from a contactable consumer. A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 23Feb2021 as SINGLE DOSE for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient received her first dose of the BNT162B2 vaccine on 23Feb2021 and day later she had symptoms of covid, body aches, not feeling well, weakness, low grade fever, tested positive for covid. In the second week she had to go to hospital for few days and was very week and still covid positive. Reporter wanted to know can patient take her second dose or if she needs to redo her series. The outcome of the events was unknown. information about lot/batch number has been requested.
85 2021-04-07 pain in extremity swollen lymph nodes after vaccination; If she accidentally picks up something or tries to pull on so... Read more
swollen lymph nodes after vaccination; If she accidentally picks up something or tries to pull on something with right arm she has excruciating pain; Right arm bicep muscle is so sore and is a hard knot; the muscles if you were going to make a muscle is very sore and hard/If I try to lift something too heavy, its excruciating pain; the day I got the shot, my hand became a little weak; This is a spontaneous report from a contactable consumer. A 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 10Feb2021 (Batch/Lot Number: EL9264) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from 21Dec2020, Stomach problem, Acid reflux, fatigue felt tired , little fever , historical allergies, Neuropathy , High blood pressure. Concomitant medications included atorvastatin; gabapentin for neuropathy peripheral,; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for an unspecified indication. The patient previously took codeine and experienced she almost passed out, demerol and experienced she almost passed out. It was reported arm that received the injection, "the muscles if you were going to make a muscle is very sore and hard". Caller says this is not the same area/muscle that the injection was given. the day I got the shot, my hand became a little weak. It went away. "Caller also says she had covid infection in Dec2020, This consumer was administered her first dose of Pfizer COVID-19 Vaccine 10Feb2021 at (Facility name). She had no problem whatsoever until 16Feb2021. Starting 16Feb2021 her right arm bicep muscle is so sore and is a hard knot; If she accidentally picks up something or tries to pull on something with right arm she has excruciating pain. She has no fever. She cannot get ahold of her doctor because their office is closed today due to the weather. She called to ask about these events; if she should put ice or heat on the affected area; how many Tylenol she should take for this. She initially reported that the affected area is the area of the muscle that you make, not in the backside muscle where the Pfizer COVID-19 Vaccine injection was administered; affected area is the front muscle, bicep that tightens when you flatten your hand forward and curl upward with the lower arm. If she raises her right arm up so far it's very painful, but not so painful that she cannot stand it. She also developed swollen lymph nodes after vaccination. Therapeutic measures were taken as a result of right arm bicep muscle is so sore and is a hard knot (muscle swelling), the muscles if you were going to make a muscle is very sore and hard/if i try to lift something too heavy, its excruciating pain (myalgia), the day i got the shot, my hand became a little weak (muscular weakness), if she accidentally picks up something or tries to pull on something with right arm she has excruciating pain (pain in The outcome of the event Swollen lymph nodes; Muscle pain; was unknown; Pain in arm; Muscle swelling was not recovered; Hands weakness of was recovered;
85 2021-04-07 pain in extremity have a lot of redness on site and a little bit of swelling; have a lot of redness on site and a litt... Read more
have a lot of redness on site and a little bit of swelling; have a lot of redness on site and a little bit of swelling; arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching; arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching; arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching; This is a spontaneous report from a contactable consumer or other non hcp. A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9269), administered in Arm Left single dose, via intramuscular route on 03Feb2021 for COVID-19 immunization. Medical history included hypertension. The concomitant medications were not reported. In the morning after her shot, her arm became sore and a redness appeared that grew to 3 inches little by little accompanied by itching. It has been going for 3 days now as of the moment. The patient stated that she still have a lot of redness on site and a little bit of swelling. Patient asked it was considered normal and this was like the third day. The patient was just put on a wet compress for the events. The patient stated that she received the 1st dose on 03Feb2021 (Wednesday) and 2nd dose scheduled after 18 days and she was asking is the timing of the 2nd dose of vaccine. At the time of this report event application site swelling and application site erythema were not recovered and other event outcome was unknown. Follow-up attempts are completed. No further information is expected.
85 2021-04-14 pain in extremity Very bad back pain--pain traveled down legs fatigue
85 2021-04-17 facial paralysis, feeling hot drooping of her face; swelling on her face; under her eyes it was sticky and hot/some areas on her f... Read more
drooping of her face; swelling on her face; under her eyes it was sticky and hot/some areas on her face feel hot; under her eyes it was sticky and hot/some areas on her face feel hot; This is a spontaneous report from a non-contactable consumer. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8727), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 14:15 (at the age of 85years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 03Mar2021 in the left arm (unspecified route) for Covid-19 immunization. The patient's medical history was reported as none. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had the second dose on Wednesday (24Mar2021) and four days later (as reported) (on 28Mar2021) she has swelling on her face and drooping of her face on the left side. It was further reported that it seems to be getting better today (31Mar2021); the drooping is almost all gone but some areas on her face feel hot; under her eyes it was sticky and hot. The reported asked if it was normal, or should the patient see the doctor. The patient was given Tylenol and she seems better. The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.
85 2021-04-18 weakness presented to Emergency room with complaints of approximately 5 days of progressively worsening short... Read more
presented to Emergency room with complaints of approximately 5 days of progressively worsening shortness of breath with a dry nonproductive cough, increased weakness, and wheezing. Symptoms not controlled with increased use of rescue inhaler albuterol. Patient's daughter reached out and spoke with patient's pulmonologist Dr. today who ordered oral steroids however patient reports she had not started taking them yet. Patient was initiated on 15 L non-rebreather and received 2 duo nebs EN route to the hospital. It was reported she did have some intermittent chest tightness although on my review, she denied this. Upon arrival to the emergency room, patient was initiated on BiPAP and receive 40 mg of IV Lasix at 125 mg of IV Solu-Medrol. Patient expired 4/19/2021
85 2021-04-21 burning sensation Five days after shot stinging, burning pain, L side front and back from spine below waist around bod... Read more
Five days after shot stinging, burning pain, L side front and back from spine below waist around body, into groin area and under stomach, down front of L leg to knee. Saw doctor on April 5, 2:p.m. for signs of diverticulitis, given Flagyl and Cipro antibiotics, asked if there was any rash. There was not. Pain that evening radiated through entire lower half of body, burning of skin intense. Went to ER. April 6, before 10:00 a.m., thinking I might have a ruptured diverticuli, for which I had major surgery 4 years prior. CT scan returned a "mild diverticulitis". Rash appeared under skin on L upper thigh on 4/8/21, looking like measles spots. Called doctor's office 4/9/21, thinking allergy to antibiotics given for diverticulitis. My records showed I had been on both before with no reaction; nurse and doctor determined by description and having seen me earlier in the week that it was shingles.
85 2021-04-26 pain in extremity Extreme fatigue for 2 days s/p 2nd shot and pain at injections site. Approximately 2 wks after 2nd s... Read more
Extreme fatigue for 2 days s/p 2nd shot and pain at injections site. Approximately 2 wks after 2nd shot, pain in right shoulder, upper arm. Pain increase and tx with cortisone injection. Pain disappeared. Approximately 10 days after pain in cervical spine, coccyx, left upper arm and right upper arm began and continues. It feel very stiff as if it need to be led and aches continually. I have high pain threshold . I've tried heat and range of motion exercises and the range of motion gives the most relief. It's like no other pain/ache/stiffness I've ever had.
85 2021-04-26 pain in extremity was achy with the first dose; sore arm with first dose; This is a spontaneous report from a contacta... Read more
was achy with the first dose; sore arm with first dose; This is a spontaneous report from a contactable consumer (patient). A 85-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK4176), via an unspecified route of administration on 22Jan2021 as single dose (at the age of 85-years) in Arm Left for covid-19 immunization. Medical history included: knee arthroplasty from Apr2018 to an unknown date (knee cap was not replaced) and breast cancer from Aug2013 to an unknown date. The patient did not receive any other vaccination within 4 weeks. Concomitant medications included: levothyroxine sodium (SYNTHROID) 200mcg daily taken for hypothyroidism (since 35 years); omeprazole 20 mg daily taken for gastrooesophageal reflux disease; furosemide 40mg daily taken for left ventricular failure from 2017 to an unspecified stop date; spironolactone 25mg, takes half tab daily, taken for left ventricular failure from 2017 to an unspecified stop date; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION), 1 daily taken for macular degeneration from 2011 to an unspecified stop date; colecalciferol (VITAMIN D) 5,000 units daily taken for vitamin d deficiency (since 6-7 years) (all are ongoing). On 23Jan2021, the patient experienced achy and sore arm with first dose. She is always achy. The degree of the achiness went away. On an unspecified date, the patient had ultrasound to check for deep vein thrombosis and results were unknown. The outcome of pain in extremity was recovered on 25Jan2021 and for another event it was unknown.
85 2021-04-26 speech disorder, weakness Woke up in middle of the night very weak, staggering, unsteady on feet, trouble speaking.
85 2021-04-26 tremor pt says she had violent shaking, like tremors for hours. She stayed in bed for about 4 days due to ... Read more
pt says she had violent shaking, like tremors for hours. She stayed in bed for about 4 days due to the fatigue. She had brain fog, dizziness and is unbalanced. She went to her PCP on 3/17/21. She had blood work with normal results. These symptoms continued all the way through to her 2nd vaccine.
85 2021-04-26 tremor pt says she developed tremors and difficulty with her balance. She has exhaustion, brain fog and fa... Read more
pt says she developed tremors and difficulty with her balance. She has exhaustion, brain fog and fatigue. On 4/23/21 she went to her PCP. Pt was referred to a Neurologist. Pt has to scheduled this appt.
85 2021-04-29 weakness After second dose: Symptoms began from March 9 - March 13 with a few day pause, then continued ongoi... Read more
After second dose: Symptoms began from March 9 - March 13 with a few day pause, then continued ongoing; Little appetite, lethargy, no energy, in bed sleeping 18 plus hours out of a 24 hour period, continued until the morning of March 13, unremarkable symptoms from March 14 thru March 22, March 23 in home nurse recommended she see a cardiologist, March 24th rushed to the hospital short of breath with irregular heartbeat; released from hospital 24 hours later -could not determine cause; 1.5 days later second visit to emergency room with the same symptoms; release from hospital 2 days laters; saw cardiologist, symptoms have persisted and progressed, currently only able to take 1/2 to 1/4 short breathes; about 15 minuets per 24 hour period will full breath capacity; 3+ pillow orthopnea: sitting up at 45 angle in order to sleep, any lower angle cannot breathe; symptoms ongoing and worsening, cause unknown
85 2021-04-30 weakness like she has been wanting to throw up/nausea, whenever she felt like throwing up; may be a stomach f... Read more
like she has been wanting to throw up/nausea, whenever she felt like throwing up; may be a stomach flu; weakness; has been feeling unwell; loss of appetite; she has been feeling shaky/nervousness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8733; expiration date: 31Jul2021), via an unspecified route of administration, administered in left arm on 25Mar2021 04:00 as single dose for covid-19 immunisation. Medical history included high blood pressure, and allergies to dust, grass, and loud smells like perfume, a lot of smells. The patient's concomitant medications were not reported. The patient received first dose of bnt162b2 on 04Mar2021 for covid-19 immunisation. She had her second dose on 25Mar2021 and had no symptoms until 20Apr2021. On 20Apr2021, she first went to urgent care because of her no appetite and they didn't do anything so then she went to the emergency room on 21Apr2021 because she tried to throw up. They gave her fluids but did not know the name of it, just that it took about 1 to 1 and a half hours. They took her blood and took her urine and did a chest x-ray. She did not have blood taken at the hospital emergency room but did have her urine taken and a chest x-ray and they didn't find nothing wrong with her. They stated it may be a stomach flu and she went home. She reported she had side effects and didn't know if it was supposed to happen. On 20Apr2021, she also had nervousness, and had no appetite, and was feeling shaky, weakness and has been feeling unwell. She has never had nothing like this and overall she has been in good condition. She stated that the side effects do not happen everyday and she tried to drink a lot of fluids and electrolytes, water and Gatorade and lays down in bed. She tried a little oatmeal but didn't have a taste for it so she ate a little soup, a noodle soup. She reported that she did not have an appetite this morning (as reported) but she did eat some soup and a lot of crackers. She was feeling good until this sickness. Her daughter stated she shouldn't have gotten the shots. She stated that maybe something was wrong, and she never had this before. Her primary prescribed Famotidine, one tablet a day 20mg, by mouth. She stated she just started taking the other day. It's for 14 days. She has 10 left, so she's been taking for 4 days. She was also prescribed Ondansetron at the hospital for nausea, whenever she felt like throwing up. She stated she does not like it and stated you put it on top of your tongue and don't drink water or eat with it. It was 1 tablet every 8 hours as needed. She reported that she was about 4'10" in height and she had shrunk because she used to be 5' height. She followed up with her healthcare provider on 04Apr2021 (as reported), who prescribed her something for acid reflux and she stated acid reflux wasn't it. The events loss of appetite and throwing up required a visit to emergency room. The patient had no previous immunization with Pfizer vaccines and no additional vaccines administered on the same date of the vaccine. There were no prior vaccinations within 4 weeks. Outcome of event may be a stomach flu was unknown; outcome of the rest of events was unknown. No follow-up attempts are needed. No further information is expected.
85 2021-05-07 face paralysis This 85 year old white female received the Pfizer Covid shot on 1/26 /21 and went to the ED on ... Read more
This 85 year old white female received the Pfizer Covid shot on 1/26 /21 and went to the ED on 1/31/21 and was admitted on 1/31/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) (CMS/HCC) I63.9 - Stroke determined by clinical assessment (CMS/HCC) R29.810 - Facial weakness
85 2021-05-13 seizure like phenomena, tremor Presented to hospital with AMS with possible seizure activity. Daughter at bedside to assist with HP... Read more
Presented to hospital with AMS with possible seizure activity. Daughter at bedside to assist with HPI, given patient's AMS. Daughter reports that she went over to see her mom at approximately 930 this morning and found her alert and oriented x3 with complaints of nausea, congestion and cough s/p her second COVID-19 vaccination, which she received yesterday. Daughter reports that at approximately noon, her mom had an episode of emesis, with her arms clenching up and shaking for approximately a minute, for which she called EMS. Daughter reports that her mom has been lethargic with AMS s/p episode. Daughter reports her mother has never had seizure activity before, but she has had several previous TIAs. She denies any recent injury, fall or medication changes. Patient lethargic with AMS noted, unable to follow simple commands, does tell me her first name with several prompts. PATIENT REMAINS HOSPITALIZED AT THE TIME OF THIS REPORT.
85 2021-05-24 inability to speak, facial paralysis Patient departed from vaccination clinic in no distress with no changes. Presented to ER with left... Read more
Patient departed from vaccination clinic in no distress with no changes. Presented to ER with left sided facial droop which started on her drive home. Per ER note, patient did have aphasia and shortness of breath. Patient had quick change of respiratory sounds with suspected flash pulmonary edema. Noted to also have facial swelling. Anaphylaxis suspected. Patient intubated and admitted to ICU with guarded condition.
85 2021-05-30 speech disorder 5/24/21 - feeling tired, vomiting 5/25/21 - speech impaired
85 2021-05-31 night sweats, hot flush Hot flashes; A little bit of uncomfortable feeling; Night sweats; Black and blue where the shot was;... Read more
Hot flashes; A little bit of uncomfortable feeling; Night sweats; Black and blue where the shot was; Swollen at injection site; next morning it was bruised; When the needle was taken out it started to bleed/Left arm bleeding at injection; This is a spontaneous report from a contactable consumer (patient). A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9264, NDC number; Expiry Date: unknown), via intramuscularly, administered in left arm on 28Jan2021 17:15 as single dose for covid-19 immunisation (prevention). The patient medical history was not reported. Other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was none. There was no family history. There were no concomitant medications. There were no additional vaccines administered on same date of the Pfizer suspect. No previous history immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No prior vaccinations (within 4 weeks). Flu shot a couple of months ago. No AE following prior vaccinations. The patient experienced when the needle was taken out it started to bleed/left arm bleeding at injection on 28Jan2021 17:30, night sweats on 02Feb2021, hot flashes, a little bit of uncomfortable feeling on an unspecified date, black and blue where the shot was, swollen at injection site was on 29Jan2021 10:00. She got first shot on 28Jan2021, and she is not on blood thinners. After the nurse took the needle out, it started to bleed. She said maybe she hit a vein. There was a little bit of uncomfortable feeling where vaccine was. The next day, she was black and blue where the shot was (The next morning it was bruised ("black and blue"). She got it around 5:15 pm. There was no prescriber. She did not speak with anyone in safety department, but she did speak with someone and she was going to change her over to someone else, but she never got to speak with anyone. She had a night sweats (It was after midnight at unknown time) and never had hot flashes ever. She felt very warm, and it went away. She took her temperature, and she did not have a temperature. If she gets second shot, she would like to know if she should get it in the right arm or left arm. Her next shot is due on 18Feb2021. There was no relevant test. No ER or physician's office required. There was no investigation assessment. There was no PQC (product quality complaint). The outcome of event hot flashes, a little bit of uncomfortable feeling was unknown and for other events it was recovering. Follow-up attempts are completed. No further information is expected.
85 2021-06-05 discomfort, inability to speak The form did not provide a place to enter the date of both doses of the vaccine. The dates were: Co... Read more
The form did not provide a place to enter the date of both doses of the vaccine. The dates were: Covid-19 (Pfizer-BioNtech), given in right arm. 1st shot: Lot # EN6198, time of vaccination unknown; 2nd shot: Lot # EN6207, time of vaccination unknown. On April 19, patient complained about left shoulder pain and went to see her general practitioner. Tests were done to rule out heart issues. On April 20, she called 911 and went to one of the two local hospitals, complaining of shoulder pain. After an xray, the diagnosis was given as tendonitis and she was sent home and instructed to take 500mg Ibuprofen morning and evening. On April 23, a rash became apparent on her left arm. She had a follow-up appointment with her GP on April 27 and was diagnosed with shingles. She continued to get more uncomfortable and confused, and late on April 29, a neighbor took her to the other local hospital where she was admitted. A lumbar puncture test confirmed that she had herpes zoster virus in the spinal fluid. She was treated in the hospital with acyclovir by IV and was released from the hospital on May 4 to a skilled nursing facility where she rehabilitated until May 14, when she was sent home. She continues to be somewhat confused and has difficulty thinking of words - much more so than before her shingles episode.
85 2021-06-16 weakness The patient experienced occurrence of E.coli sepsis on 15Mar2021 and ended up in hospital; The patie... Read more
The patient experienced occurrence of E.coli sepsis on 15Mar2021 and ended up in hospital; The patient experienced occurrence of E.coli sepsis on 15Mar2021 and ended up in hospital; The patient got so weak; This is a spontaneous report received from a contactable retired registered nurse (patient). An 85-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in arm left (left shoulder, but not certain) on 20Feb2021 11:30 (Batch/Lot Number: EN6701) at age of 85-year-old at single dose for COVID-19 immunization (the patient didn't want to catch COVID and wanted to have antibodies to fight it). Vaccine was not administered at known Facility. Medical history included first hospitalization for E.coli (Escherichia coli) sepsis was in Feb2021, prior to receiving the first dose Pfizer COVID Vaccine, the patient received more antibiotics from home health and the patient was in the hospital for five days from 01Feb2021 to 05Feb2021 and had the last antibiotic on 09Feb2021. Concomitant medications included ceftriaxone (ROCEPHIN) and cefalexin (KEFLEX) taken for E.coli sepsis from 15Mar2021 to 02Apr2021. Prior Vaccinations (within 4 weeks) there was not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient experienced occurrence of E.coli sepsis on 15Mar2021 and ended up in hospital. The patient had been in the hospital again after receiving the first dose Pfizer COVID Vaccine for the patient's second occurrence of E. Coli sepsis. The patient was in rehab by 01Apr2021 and was taken by medical transport at the hospital to receive her second dose Pfizer COVID Vaccine. The patient clarified she had E.coli sepsis twice. The patient's first hospitalization for E.coli sepsis was from 01Feb2021 to 05Feb2021, prior to receiving the first dose Pfizer COVID Vaccine. The caller's second hospitalization was from 15Mar2021 to 02Apr2021, the patient was in rehab for three weeks. The patient stated she was no longer on any antibiotics. The patient was on ceftriaxone first and then cefalexin, IV. The caller was in the emergency room on 15Mar2021 and they admitted the patient at health facility for three days, then they transported the patient to a bed in the rehab area because the patient needed another 21 doses of antibiotics and the patient needed to learn to walk again. The patient got so weak. The patient was discharged on 02Apr2021. The event E.coli sepsis required visit to emergency room and physician office. Relevant tests were none. The outcome of the events was unknown.; Sender's Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported E.Coli Sepsis. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
85 2021-06-24 pain in extremity My arm was a little sore; 5-6 big bumps; This is a spontaneous report from a contactable consumer or... Read more
My arm was a little sore; 5-6 big bumps; This is a spontaneous report from a contactable consumer or other non hcp. A 85-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Jan2021 09:30 (at the age of 85-year-old) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 28Jan2021 17:30, the patient experienced 5-6 big bumps on the left side of her forehead, next to her eye and biggest one was the size of a milk dud. They were protruding like a gumdrop. These lasted about 3-4 days. Now she can push on the area with her hands on her forehead and feels 1 indention. The bumps have now went away for the most part. The reporter stated that she didn't know whether it was a clot or something else happened. On an unknown date, patient experienced, arm was a little sore. Patient was due for the second shot 18Feb and so worried about it. The outcome of the event bumps was recovering, however the outcome of the event arm was little sore was unknown. Information on the Lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
85 2021-06-24 pain in extremity There is something wrong her left knee; Pain went from her arm then went down to her knee/Pain in le... Read more
There is something wrong her left knee; Pain went from her arm then went down to her knee/Pain in left knee; Pain went from her arm then went down to her knee/Pain in left knee; This is a spontaneous report from a contactable consumer. A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL9265, Expiration date: Unknown) via an unspecified route of administration, in left arm on 30Jan2021 (at the age of 85-year-old) as 1st dose, single for Covid 19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she was in the hospital for 3-4 days, prior to vaccination, from 21Jan2021 to 23Jan2021, no further details provided. As per report it was reported that "patient got first dose of the Pfizer covid vaccine on Saturday, 30Jan2021 at the (Place name), stated that on Wednesday, Thursday and on that day (03Feb2021), the pain went from her arm then went down to her knee, she has the worst pain in her left knee and she stated that there is something wrong her left knee after getting the first covid vaccine shot. She cannot wear her prosthesis and she has a below the knee prosthesis and right above the kneecap was so painful. She could not stand the pressure, she was rubbing it with everything she has, using icy hot, biofreeze and arthritis Tylenol for the treatment. Stated the pain from the injection was gone. She stated that she was on another medication but did not believe it was relevant. The outcome of events arthropathy, pain extremity and arthralgia was not resolved. Follow-up attempts completed. No further information expected.
85 2021-07-08 weakness Participated in skilled therapy, continued visits w/oncologist, vaccine requested and administered, ... Read more
Participated in skilled therapy, continued visits w/oncologist, vaccine requested and administered, continued skilled therapy w/decrease in strength as what brought resident to SNF w/RLE cellulits w/MRSA, Vaccine series completed, continued skilled therapy, WBCs chronically elevated per oncologist as expected may occur w/cancer tx med for active leukemia. Continued decline overall w/decline in intake of food and fluids, hospice care initiated. Over the course of months, resident declined to bedrest w/expiration 5/24/21.
85 2021-07-12 pain in extremity, weakness urinary tract infection; sore arm; limited her ability to do things; angiogram showed mild blockage;... Read more
urinary tract infection; sore arm; limited her ability to do things; angiogram showed mild blockage; progressively been getting weaker/weakness; bones periodically get icy cold; had heavy breathing which was difficult to control even with her focusing on her breathing; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 85-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6201; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Deltoid Left on 17Feb2021 at 03:00 as dose 2, single for COVID-19 immunisation. Medical history included atrial fibrillation. The patient's concomitant medications were not reported. The patient previously took BNT162B2 for covid-19 immunisation and experienced asthenia on 30Jan2021. Relevant medical history and concurrent conditions included a fib. The patient has allergy to iodine. The patient did not receive prior vaccinations within 4 weeks. The patient did not receive any prior vaccinations within 4 weeks of receiving covid-19 vaccine. The patient has been keeping a daily journal for over 20 years and she noticed a trend of her symptoms after the vaccines. On 29Mar2021, the patient experienced progressively been getting weaker/weakness, a feeling from the top of her head to her knees. In Mar2021, the patient experienced bones periodically get icy cold. On an unknown date, had heavy breathing which was difficult to control even with her focusing on her breathing; on an unspecified date, the patient experienced sore arm, urinary tract infection, limited her ability to do things and on 22Mar2021, the patient experienced angiogram showed mild blockage, so it does not require surgery. The patient knows there have been reports of body aches then you could say sensations numbness, tingling, etcetera. The patient wakes up and is good for about an hour at most and then she gets weakness. The patient went by ambulance to the emergency room on 1Mar2021, due to the weakness and was out on same day. The patient underwent lab test which included, COVID-19 virus test which was negative on 01Mar2021. On 22Mar2021 Angiogram showed mild blockage. On an unknown date, the white blood cell count was normal. Therapeutic measures were taken with a bag of Rocephin. The patient was on a recording monitor and it sends reports to her cardiologist every night and it has not noted an event in over 90 days. The clinical outcome of the events progressively been getting weaker/weakness was not recovered; bones periodically get icy cold, sore arm, angiogram showed mild blockage, had heavy breathing which was difficult to control even with her focusing on her breathing, limited her ability to do things urinary tract infection was unknown. No follow-up attempts needed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021633718 similar report from same reporter
85 2021-07-17 paralysis was paralyzed from the waist down; muscle weakness in my legs; had 2nd dose of Pfizer Vaccine on 18J... Read more
was paralyzed from the waist down; muscle weakness in my legs; had 2nd dose of Pfizer Vaccine on 18Jun2021; This is a spontaneous report from a contactable consumer (Patient). An 85-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration, administered in left arm on 18Jun2021 at 10:00 AM (at the age of 85-years-old) as dose 2, single for COVID-19 immunization. The patient medical history included high blood pressure and known allergies. The patient did not have covid prior vaccination. Concomitant medications were not reported. The patient did not receive any other vaccine within four weeks of vaccination. Patient received other medications (unspecified) in two weeks. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration, administered in left arm on 04Jun2021 at 10: 00 AM as dose 1, single for COVID-19 immunization. The gap between the two doses of vaccine was 14 days which was an inappropriate schedule of vaccine. On 18Jun2021 by 5:30 PM (same day of vaccination), patient was paralyzed from the waist down, and was in ICU for 2 days. The patient was given steroids as the treatment. The paralysis went away but left with muscle weakness in my legs. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability, or permanent damage. The patient was not tested for COVID-19 post vaccination. The outcome of event paralyzed was recovered with sequel, and muscle weakness in legs was not recovered.
85 2021-07-19 speech disorder Inoculated woman spoke words that made no sense, backed her car through the closed garage door, did ... Read more
Inoculated woman spoke words that made no sense, backed her car through the closed garage door, did not respond to stroke questions, was taken to hospital by ambulance, had an MRI, and was diagnosed with a blood clot in her brain. The blood clot was removed; speech therapy was required.
85 2021-07-23 pain in extremity SUMMARY: New onset of arthritis-like joint pain affecting bilateral fingers, wrists, elbows, should... Read more
SUMMARY: New onset of arthritis-like joint pain affecting bilateral fingers, wrists, elbows, shoulders, and knees. Pain onset was temporally associated with the second COVID-19 vaccine shot. It began within one week of the shot and has persisted since then. "At times it is extremely painful and throbs. It affects me at night and sometimes the pain keeps me awake, but it is especially bad in the mornings. Sometimes I have pain both in pulling the blanket over me at night and taking it off in the morning. It has gotten so bad that I dread getting up each day. Some days I can barely get out of bed. I do feel better after I am up and moving around. Oddly, the pain moves from one area to another, affecting different joints in my body. It doesn't stay consistently in the same joint(s). It is really weird. I've had occasional aches before, such as in my lower back, but I have never felt anything like this. It is definitely new and came on all of a sudden. I believe that the vaccine triggered something in my immune system that has caused this new joint pain. CHRONOLOGY: I had my first Pfizer COVID-19 vaccine shot on February 10, 2021. Three weeks later, I had my second shot on March 4, 2021. Ever since then (beginning approximately on March 10, 2021), I have had these new and very bizarre aches in my joints. It started in my left fingers. They felt extremely stiff in the mornings and I had numbness and tingling in my hand. It felt like I couldn't even move it. It was weird. I have never felt anything like it before. It's not you usual "pins and needles" when your arm "goes to sleep." Shortly after that, it affected my right hand too. Some mornings it is almost impossible to straighten them. They are so stiff that I feel like I am going to break them if I move them. It didn't happen every morning at first, but it is becoming more consistent, over time. Once I get up and start moving in the morning, the joint pain usually goes away. Sometimes, I have a shooting pain in my hands and I think there may be nerve damage. I have also noticed that my grip strength in my hands has decreased. My hands are much weaker than they used to be. In addition to my bilateral fingers, this new arthritis has affected my bilateral wrists, elbows, and my right shoulder. When I saw my PCP on April 6th, 2021, my knees were not affected because I remember being able to get up from a seated position very easily. My doctor even commented on how agile I was. That has generally been true for me over the years. In the last month, though, since approximately June 15th, 2021 my knees have started to be affected by the same pain and stiffness. I notice it especially when I am getting up from a seated position. I have to hold onto something for support. Then, on approximately July 1, 2021, the pain and stiffness also started affecting my left shoulder. My right shoulder bothers me less now. It is very strange how the pain seems to move around from one area to another. So far, it has not affected my neck, my hips, or my feet. When I saw my PCP on April 6th, 2021, it was because I was having a lot of fatigue and I felt short of breath. I also told him about my joint pain and how I thought the vaccine caused it, since it seemed to start right after the second dose, but he dismissed it as being arthritis. I knew, however, that this was new for me and that I had never had it before. When I saw my Pulmonologist shortly thereafter, I told her about my symptoms and how I thought the vaccine had caused them. She said, "It absolutely could be." The most severe pain I have experienced to-date has been in my right wrist. I remember a sharp pain one day in February 2021, when I was trying to twist an ice cube tray. I do not recall if this was before or after my first vaccine shot on February 10, 2021. The tray was frozen pretty solid and it was hard to twist it to get the ice cubes out. I am left-handed and I remember that my right wrist was sore for several days afterwards. That right wrist pain still comes and goes. Sometimes I feel it every morning for a while, and then I won't. I have kept my wrist wrapped in a bandage and I am careful with how I use it, but I must have done something to aggravate it, because on Monday morning, May 24th, 2021, I got up to go to the bathroom and my right wrist hurt a lot. I had a hard time pulling up my underwear and pants. My right shoulder bothered me too. I got back into bed but I had a hard time pulling the covers back up over me. The pain worsened. It was almost unbearable and I was in tears. My husband got up a little later to go use the bathroom. He asked if I was okay and I said, "No, my wrist is killing me and I cant go back to sleep." He brought me hot washcloths to wrap around my wrist and this helped. He must have brought me fifty hot washcloths. The next morning, I called my PCP and asked for a referral to see a rheumatologist. I have an appointment pending on August 5, 2021. Then, on Wednesday, May 26, 2021, my right wrist pain was excruciating. I contacted my PCP and made an appointment for the next day. The pain subsided a bit and I kept my wrist wrapped. I was careful with how I used it, but the pain started up again in the morning after I got dressed. I was in tears because it hurt so much. I couldn't even touch it. It was swollen. I had trouble moving my right 4th and 5th fingers too. I used a heating pad and took Tylenol and they helped to take the edge off, but it still hurt. I wondered if I had a fracture or a torn tendon or ligament. I asked my doctor to give me an order for imaging so that I wouldn't have to go through the ER. The A.P. x-ray of my wrist did not show any fractures, but my doctor wrote in his note that there is a "deformity" in the wrist. I have tried a topical pain reliever, Aspercream, with minimal relief. I have not had the excruciating pain in my right wrist since May. I had hoped that the arthritis-like pain and stiffness would gradually go away with time, but it has persisted, off and on. Most mornings, I continue to have pain. I am now afraid to get a booster shot of the COVID vaccine if one is need because I don't want my pain to get worse."
85 2021-07-27 discomfort headaches; muscle aches; pains; chills; other flu-like symptoms; Hard of hearing; Kind of stiff; Lit... Read more
headaches; muscle aches; pains; chills; other flu-like symptoms; Hard of hearing; Kind of stiff; Little bit of discomfort; Trouble in seeing; I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it.; Skin dry; This is a spontaneous report from a contactable consumer or other non-HCP (patient). An 85-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Feb2021 (age at the time of vaccination 85-years-old), as single dose for COVID-19 immunization. The patient's medical history included Hypertension, Stroke, Heart attack, and on an unspecified date Aug2020, Covid-19, I actually had a mild case of COVID. The patient's concomitant medication included Isosorbide, Losartan, and Cartia Xt (Diltiazem Hydrochloride). On an unspecified date, the patient experienced headaches, muscle aches, pains, chills, other flu-like symptoms, Hard of hearing, Kind of stiff, Little bit of discomfort, Trouble in seeing, I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it, and Skin dry. On an unspecified date Aug2020, the patient underwent lab tests and procedures which included Covid-19: positive, I actually had a mild case of COVID. The outcome for all the events was unknown. No follow-up attempts are needed. No further information is expected.
86 2021-01-10 speech disorder DAY AFTER VACCINATION (1/6/21) AT APPROXIMATELY 12:30PM, DEVELOPED FATIGUE, DIFFICULTY TALKING, NAUS... Read more
DAY AFTER VACCINATION (1/6/21) AT APPROXIMATELY 12:30PM, DEVELOPED FATIGUE, DIFFICULTY TALKING, NAUSEA, AND MALAISE. SYMPTOMS RESOLVED IN 1 HOUR.
86 2021-01-17 tremor, seizure like phenomena Resident had seizure like activity that was about 30 minutes in duration where her upper/lower extre... Read more
Resident had seizure like activity that was about 30 minutes in duration where her upper/lower extremities were shaking uncontrollably. Resident had to be admitted into hospital for observation.
86 2021-01-21 slurring, bell's palsy Slurred Speech Bels Palsy
86 2021-01-24 speech disorder throwing up; Sweating; Lightheaded; the patient can barely speak to her/she just whispered it; This ... Read more
throwing up; Sweating; Lightheaded; the patient can barely speak to her/she just whispered it; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC9231, expiry date Apr2021), intramuscular in the left arm on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 from 13Apr2020 and she got a plasma donation, in Apr2020 because she was not in good shape when she had COVID. There were no concomitant medications. The patient previously took first dose of bnt162b2 (lot number and expiry date not reported) on an unspecified date at single dose for COVID-19 immunisation. The reporter said that the patient's doctor told her to still get the COVID vaccine and on 10Jan2021, she had been throwing up, sweating, and lightheaded and these were the side effects with the second dose. The caller stated that no one else had side effects like these. It was reported that the patient had no other family and the reporter felt really bad for the patient and wanted to get her some sort of information. The patient said that she was feeling a little better than she did last night, but she was laying in bed. The patient's symptoms started yesterday 10Jan2021, the next day after receiving the vaccine. The reporter said that the patient can barely speak to her. She said that the patient said that she was feeling a little better, but she just whispered it. The reporter asked if it was because the patient had antibodies. Clinical outcome of the events was unknown.
86 2021-01-26 unresponsive to stimuli Resident became rigid with eyes crossing and rolling back in her head. She was unresponsive and bec... Read more
Resident became rigid with eyes crossing and rolling back in her head. She was unresponsive and became limp. Pulse Ox decreased to low 80's. She came to and then was agitated throughout the day.
86 2021-01-27 weakness dizzy; She is kind of weak; The initial case was missing the following minimum criteria: No adverse ... Read more
dizzy; She is kind of weak; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 14Jan2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. An 86-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3249, expiration date not reported), via an unspecified route of administration on 13Jan2021 at single dose for COVID-19 immunization. Medical history included diabetes from an unknown date. The patient experienced dizzy and she is kind of weak on 14Jan2021. It was further reported that the events started this morning, she was fine yesterday. The patient underwent lab tests and procedures which included blood glucose: 145 on an unspecified date. The patient did not recover from the events.
86 2021-01-27 unresponsive to stimuli, speech disorder Client recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic. Client tested positive for COV... Read more
Client recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic. Client tested positive for COVID-19 by rapid testing on 1/21/21, with c/o hurting all over and loose stools. She became non-verbal on 1/23/21 with poor intake. On 1/24/21 at 0537 Client was unresponsive and without vital signs. Orders were for DNR, and CPR was not initiated.
86 2021-02-02 pain in extremity Same day as vaccination given, developed pain went from arm up to shoulder, to back, to neck to head... Read more
Same day as vaccination given, developed pain went from arm up to shoulder, to back, to neck to head - right side of body; chills/body aches
86 2021-02-03 weakness Severe weakness, acute stomach pain, nausea, shortness of breath.
86 2021-02-04 inability to speak Patient received her vaccine on 01/25/2021. Two days later, she presented with an acute right MCA s... Read more
Patient received her vaccine on 01/25/2021. Two days later, she presented with an acute right MCA stroke with aphasia.
86 2021-02-04 pain in extremity she threw up; her legs hurt; so tired; This is a spontaneous report from a contactable consumer (pat... Read more
she threw up; her legs hurt; so tired; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Lot number: Unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She got the vaccine on 15Jan2021 and on an unspecified date in Jan2021 she threw up and her legs hurt, and it just keeps on going down the list. She also reports that she was feeling "so tired" on an unspecified date in Jan2021. She reported that it has almost been 7 days and she is still having side effects. Information on the Lot/Batch number has been requested
86 2021-02-04 tingling Client was assessed by EMD due to chief complaint of tingling of the left hand and fingers after rec... Read more
Client was assessed by EMD due to chief complaint of tingling of the left hand and fingers after receiving the vaccine. Client states the sensation (tingling) has gone away. Client was cleared by EMT to go home.
86 2021-02-06 night sweats, feeling cold, feeling hot, tremor general body aches, chills first- went to bed- then body shaking-during night had nausea, more of bo... Read more
general body aches, chills first- went to bed- then body shaking-during night had nausea, more of body issues and felt hot- took Tylenol PM-apparently passed out coming from bathroom. took one Tylenol and one Ibuprofen. stayed in bed until late morning. tried to hydrate but probably not enough. stayed up most of day- late afternoon chills returned and temperature 100.1 - took 2 Tylenol. went to bed 8:00- woke during night sweating and nightclothes drenched. got up this morning - 02/07- feeling better- some body aches and fatigue which could be from inactivity.
86 2021-02-07 weakness Headache and "Not feel well" 2/3/21 4:20AM Nausea, weak, tired, diarrhea 2/3/21 9:56AM Vomited and... Read more
Headache and "Not feel well" 2/3/21 4:20AM Nausea, weak, tired, diarrhea 2/3/21 9:56AM Vomited and "almost" diarrhea 2/3/21 2:04PM Loose BM and nausea 7:10PM 2/3/21 7:10PM
86 2021-02-09 weakness Extreme vertigo starting about 6:30 am on 1/21/2021, unable to get out of bed until 12:30pm on 1/22/... Read more
Extreme vertigo starting about 6:30 am on 1/21/2021, unable to get out of bed until 12:30pm on 1/22/2021 due to dizziness and nausea, hallucinations during this time, some low fever. Continued spells of weakness, dizziness and nausea for two weeks.
86 2021-02-09 facial paralysis Patient had no discomfort following vaccination until 2 days later on 2/5. She began to have extreme... Read more
Patient had no discomfort following vaccination until 2 days later on 2/5. She began to have extreme pain, a hard knot, and redness at the injection site. On 2/6, she had diarrhea, altered vision in the right eye. and "face hung down" Symptoms lasted about 36 hours. By Monday 2/8/2021, symptoms were completely resolved with no residual effect.
86 2021-02-09 tingling, numbness Sore and numbness and tingling down to fingers. Mostly now down to elbow.
86 2021-02-10 cold sweat 0950: Pale, lethargic, cool and clammy; respond to command. Transferred from chair to wheelchair. Vi... Read more
0950: Pale, lethargic, cool and clammy; respond to command. Transferred from chair to wheelchair. Vital signs : BP 77/50, repeat BP158/91, SPO2 95%. Individual transferred to stretcher, O2 @ 2L via face mask; continue to respond to command -orientation x2 place and day. 10:02 BP 186/98, SPO2-100%, Pulse 80, Temp- 97.5. Patient alert and having conversation. 10:04 Rescuer (Fire Dept.) arrived - report of patient given. Lead rescuer assessed patient . Request to be transported to ER declined by patient.
86 2021-02-10 feeling cold, inability to speak, weakness, difficulty speaking, facial paralysis, numbness Numbness in face, legs; Slight headache; Whole chest froze up; It has been an effort to talk, she wa... Read more
Numbness in face, legs; Slight headache; Whole chest froze up; It has been an effort to talk, she was really working hard to talk; Muscle tightness around her whole face; Legs weren't steady enough; Didn't feel well; She was very weak; Could only stay awake for very short amounts of time; She never had trouble with her stomach like this before; Lip has a slight droop on left side of her face; Felt like she was having a heart attack; Felt extreme exhaustion; Not able to eat; She thought she has low blood sugar; This is a spontaneous report from a contactable consumer (the patient). An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiration date not reported), via an unspecified route of administration (left arm) on 21Jan2021 14:50 at a single dose for COVID-19 immunization. Medical history includes therapy on her back from the past, from an unknown date. Concomitant medication included melatonin to sleep and, paracetamol (TYLENOL) to sleep. The patient received the first dose of the vaccine on 21Jan2021 at around 2:50 PM, the next morning on 22Jan2021, she felt extreme exhaustion, she'd get up and have to get back to bed, not able to eat, and she thought she has low blood sugar. She got up and had a bowl of cereal. On an unspecified date, the patient also reported numbness in face, legs and slight headache, and need to eat all of a sudden or pass out, and these has gone on for five days now (at time of report). The patient also reported that her lip has a slight droop on left side of her face which was concerning her. The patient reported that after numbness and not eating, she had some ice cream and her whole chest froze up, and it felt like she was having a heart attack. Her chest felt like ice which never had happened before. It has been an effort to talk, she was really working hard to talk. The patient explained she got the vaccine 5 days ago (from the time of report) and reported she had muscle tightness around her whole face, she had a slight droop on the left lip, a slight headache right across the eye brows, her legs feel a little numb off and on, she got feeling of tiredness but that passes, she had the need to go eat suddenly or she will get very weak. The reason for the call was she was wondering if she should she go for the second vaccine when 5 days after having the vaccine she was experiencing numbness. Slight droop on the left lip started but never looked close until the time of report, not a lot but the lower lip on the left side it is slightly droopy, with slight headache right across the eye brows. Her legs felt a little numb off and on, and she stated that about 3 days after the vaccine, she was afraid to take a shower because her legs weren't steady enough. They are still that way at the time of report, but this did go away for a while on a day and she was able to take a shower. She also didn't feel well after the vaccine. On the day of the vaccine, she had a good dinner and felt good; but the next morning she was very weak and could only stay awake for very short amounts of time. She was in bed and couldn't stay up and this is not like her, she did not like to be in the bed. She got the feeling of tiredness but that passes and she can stay up for longer periods of time. She had to go eat or she gets very weak, she didn't feel like eating in the beginning. It was on the 4th day after the vaccine she would have to get a bowl of cereal all of a sudden or she would feel like she was going to pass out. She never had trouble with her stomach like this before where she felt the need to have to go and eat. She explained she never had trouble with stomach, she never had headaches, and never had a vaccine before. Muscle tightness around her whole face started 2 days after getting the vaccine and was getting worse. Her face felt really tight almost numb feeling. The outcome of the events was unknown.
86 2021-02-11 weakness, pain in extremity The morning after vaccination, sore arm, fatigue, and weakness, mainly of the legs. The symptom... Read more
The morning after vaccination, sore arm, fatigue, and weakness, mainly of the legs. The symptoms lasted four days.
86 2021-02-12 weakness much more dizzy than first vaccine. Completely weak. 2/11 Next day: same symptoms plus chilled all d... Read more
much more dizzy than first vaccine. Completely weak. 2/11 Next day: same symptoms plus chilled all day. No appetite. 2/12 third day: weakness subsiding, slightly dizzy, very little appetite. 2/13 fourth day: Legs weak but much improvement
86 2021-02-13 facial paralysis Less than 24 hours after receiving 2nd dose of vaccine, resident developed symptoms of fever (101.7F... Read more
Less than 24 hours after receiving 2nd dose of vaccine, resident developed symptoms of fever (101.7F), body aches, peri-orbital fluid in right eye, right eyelid ptosis with mild facial droop, tongue deviates to the right.
86 2021-02-16 pain in extremity Blood blister; hands, feet, torso are covered and painful/soreness and tenderness of palms; has trou... Read more
Blood blister; hands, feet, torso are covered and painful/soreness and tenderness of palms; has trouble with ambulation; torso are covered and painful; This is a spontaneous report from a contactable nurse (patient's daughter). An 86-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry: Mar2021), intramuscular in the left upper arm on 25Jan2021 13:30 at a single dose for protection against virus. Medical history included COVID from 18Nov2020 and ongoing (recovering/resolving). The patient's concomitant medications were not reported. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry: Mar2021) intramuscular in the left arm on 04Jan2021 for protection against virus with no problem. On 26Jan2021, patient had one tiny blood blister but now was covered in them. Her hands, feet, and torso are covered and are painful. The patient has trouble with ambulation and using her walker since. The palms of her hands are covered front and back too. The patient was also covered on her toes and areas of the abdomen around the umbilicus area. Had the first dose on 04Jan2021 and the second on 25Jan2021. Her mother has an appointment on 03Feb2021, and caller wanted to know if this is uncommon or a rare side effect. The reporter has found a couple of articles, but most of them refer to pediatrics and rashes and she didn't see any side effects about blood blisters for her mother's age group. Further stated that areas covered are progressively worse and disabling since her mother was using a walker to ambulate. Has not been able to really use the walker due to the soreness and tenderness of palms. Her mother had the disease (COVID) back on 18Nov2020 and was symptomatic and was mild. No other vaccines received the same time. No history of problems with vaccines in past. They can't think of nothing that was new, no new medications, lotions, creams, or detergents, nothing new. The events did not require a visit to emergency room nor a physician office. Onset date of events reported was on 26Jan2021 with outcome of not recovered. The reporter assessed the seriousness of events as disability. The events were assessed as related to vaccines.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
86 2021-02-21 weakness 48 hours after the injection, patient had difficulty standing, walking, and had severe weakness. She... Read more
48 hours after the injection, patient had difficulty standing, walking, and had severe weakness. She was unable to stand for more than 5 minutes. Unable to put on her shoes, make her food, and needed assistance with dressing. She has improved over the week but still has difficulty with meals and dressing. Is able to walk for a few minutes and uses a walker and a wheelchair for longer trips.
86 2021-02-22 muscle spasms Pt. c/o of cramping all over & shortness of breath.
86 2021-02-25 weakness 1st dose vaccine 2/3/21; 2nd dose 2/24/21; developed weakness, inability to keep balance, and worsen... Read more
1st dose vaccine 2/3/21; 2nd dose 2/24/21; developed weakness, inability to keep balance, and worsening LE edema 2/25/21 ; seen in ED 2/25/21 for above symptoms; DX 1. Hypervolemia, unspecified hypervolemia type 2. Weakness
86 2021-02-28 bell's palsy Resident presented with stroke like symptoms on 2/27/21 and was transferred to the emergency room. ... Read more
Resident presented with stroke like symptoms on 2/27/21 and was transferred to the emergency room. She was diagnosed with Bell's Palsy and sent back to the facility. Resident received 1st dose of Pfizer vaccine on 1/24/21 and 2nd dose on 2/14/21.
86 2021-02-28 pain in extremity left arm painful; This is a spontaneous report from a contactable nurse (patient). An 86-year-old fe... Read more
left arm painful; This is a spontaneous report from a contactable nurse (patient). An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9265), via an unspecified route of administration in the left arm, on 03Feb2021 at 12:05 (at the age of 86-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient had no family history related to the adverse events. The patient had no prior adverse events to vaccinations nor any prior vaccinations within four weeks of vaccination. There were no additional vaccines administered on the same day. The patient experienced left arm painful on 06Feb2021, which was reported with disability. The clinical course was reported as follows: The first 3-4 days (as reported), there were no side effects; however, her arm was painful for days 5- 7, and on day 9, it was still a little sore but better. Therapeutic measures were taken as a result of the event, which included a visit to the chiropractor. The clinical outcome of left arm painful was recovering. The primary reporter (patient) assessed the causality between the event and the suspect product as related.; Sender's Comments: Based on the information available, a causal relationship between event "left arm painful" and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
86 2021-03-02 weakness, pain in extremity, feeling of body temperature change delirious: incapable of sleeping, insomnia and inability to be awake and aware; high, over the top b... Read more
delirious: incapable of sleeping, insomnia and inability to be awake and aware; high, over the top blood pressure; Sweating; on and off chills; she gets warm and cold, hot and cold; concerned about one kidney/ was dehydrated; affecting her kidney; incapable of sleeping, insomnia; she was weak; feeling like she would slip onto the floor; she is still not clear headed; she is woozy, like foggy; she is still not clear headed, she is woozy, like foggy; arm is still sore from second vaccine; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number EL9262 expiry date 21May2021), via an unspecified route of administration on 12Feb2021 (at the age of 86 years old) at single dose in right arm for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number EL8982) on 22Jan2021 at single dose in upper right arm and on 22Jan2021 experienced severe headache and arm hurting. Relevant medical history includes ongoing compromised immune system diagnosed many years ago, and ongoing one kidney functioning. The patient received no concomitant medications. On 13Feb2021 the patient experienced high, over the top blood pressure, delirious incapable of sleeping, insomnia and inability to be awake and aware which both required hospitalization from 13Feb2021 to 14Feb2021. It was also reported they were concerned about one kidney/ was dehydrated in 13Feb2021. On 13Feb2021 unspecified blood labs showed kidney was extremely dehydrated and Chest X-ray was good. Clinical course was reported as follows: she was just released from hospital yesterday, she took the second Pfizer COVID shot, on 12Feb2021, and became so very very ill, she expected some side effects, the first shot wasn't bad, the first all she had was a severe headache and arm hurting, but that was 3 weeks ago, and the second one she can't say how horrible it was: she had to get the paramedics there, she was very very ill. It was the worst night she has had, and she is 86 years old, and has had a multitude of serious issues but that shot was the worst. It was a combination of high blood pressure, over the top, and insomnia like she couldn't budge and open her eyes, she couldn't see anything but squares, it was like a horrible, if there is such a thing as a trip, a horrible trip, something she can't imagine wishing on anyone. The county administered it, she has several doctor, she initially provides her primary care doctor, for consent to contact, but says her nephrologist would be better, as she hasn't seen her primary care doctor in some time. Her primary care doctor doesn't know she had this, another doctor gave her permission, her nephrologist. States they were more concerned in the hospital about her kidney, she has one kidney functioning and, on mistake of the hospital, they didn't connect her to hydration, the night nurse didn't, and she was dehydrated and it was affecting her kidney. Her husband tried to call Saturday, when she had this reaction at like 06:30/07:00, but there was a huge long wait, he was calling to see about side effects, but they were beyond waiting, had to get the paramedics, her blood pressure was 178/113 and heart rate was 103. First shot was 3 weeks back. It looks like she had it on 22Jan2021, the headache and arm hurting started towards the evening, the shot was taken earlier in the day, and they started in the evening, her headache was quite severe, but with Tylenol it went away, the arm is still sore from the second vaccine, but is slightly better. Clarifies she was hospitalized for the blood pressure and delirium, like, it is best explained, like delirious: incapable of sleeping, insomnia and inability to be awake and aware, all she could see was, like if she talked about people who did LSD and trips, it was a bad trip, it was squares, she wanted to open her eyes, but could only see squares. She fell asleep Friday night about 11PM, and felt this at 04:00, and she pulled off her sleep apnea mask, she had to run to the restroom, she was weak, feeling like she would slip onto the floor, and had to get right in bed, and the insomnia continued until about 7AM, that was when she started to be able to focus on like words, she was able to say words in her mind, it was like a bad nightmare. She was admitted to the hospital, she was in the emergency room (ER), the paramedics took her there Saturday, about 07:30, took her to the hospital after immediate heart checking, an intravenous (IV) of some kind, and brought her to the hospital and she was in X-rays and what not, they did procedures in the ER, and they suggested her to be observed overnight, they watched her and things started to become more normal, but she is still not clear headed, she is woozy, like foggy. High, over the top blood pressure outcome: It has been back to a good blood pressure. Insomnia is ok- she slept ok last night. What is left: the night she woke up, so early Sunday morning, in the hospital, she was profusely sweating like someone came to her room and showered her bed with water, her sheets and blankets were soaked and this morning she woke, she got up, was still very woozy, and asked her husband to help get her out of bed, and she changed her nightgown and after an hour she got in the shower, as she was sweating again, not sweating, but occasionally on and off chills, she is taking off her nightshirt and putting on a bed jacket, she gets warm and cold, hot and cold. She had blood labs a chest X-ray, heart monitor the whole time until she was discharged, and everything was good except the kidney was extremely dehydrated. This was all on Saturday as well. On her first visit to get the vaccine, at that time, the facility was a big mall, and they handed her what to look for after the injection, and she didn't notice until this morning, it says if you have an immune system that is compromised, it could affect it, and she has immune system that is compromised diagnosed many years ago. Over the top blood pressure and insomnia had resolved, arm sore was resolving, dehydrated and affecting kidney had not resolved, final outcome of the remaining events was unknown.
86 2021-03-02 weakness Patient with 3-7 days of weakness. Hospitalized 2/16-2/20 for fever weakness and SOB. Diagnosed with... Read more
Patient with 3-7 days of weakness. Hospitalized 2/16-2/20 for fever weakness and SOB. Diagnosed with COVID-19 and UTI. Did require O2 per NC briefly. Was treated with IV/PO dexamethasone and IV/PO Cipro Discharged to home
86 2021-03-02 numbness, tingling Left sided numbness, tingling of face, arm and leg. Loss of hearing in left ear. Called 911. Air ... Read more
Left sided numbness, tingling of face, arm and leg. Loss of hearing in left ear. Called 911. Air rescue to Hospital. Workup labs, CT, MRI and carotid ultrasound. Symptoms resolved 5 hours.
86 2021-03-02 pain in extremity severe headache; arm hurting/arm sore; This is a spontaneous report from a contactable consumer. Thi... Read more
severe headache; arm hurting/arm sore; This is a spontaneous report from a contactable consumer. This consumer reported for herself that an 86-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982, expiration date: 20May2021) at the age of 86-years, via an unspecified route of administration in upper right arm on 22Jan2021 at single dose for COVID-19 immunization. Medical history included compromised immune system (diagnosed many years before) and ongoing one kidney functioning. Concomitant medications were none. The patient experienced severe headache and arm hurting on 22Jan2021. It was reported that the first shot wasn't bad, the first all she had was a severe headache and arm hurting. It looks like she had the first on 22Jan2021, the headache and arm hurting started towards the evening on 22Jan2021, the shot was taken earlier in the day, and they started in the evening, her headache was quite severe, but with paracetamol (TYLENOL) it went away, the arm was still sore from the second single dose of BNT162B2 on 12Feb2021 for COVID-19 immunisation, but was slightly better. Outcome of the event headache was recovered/resolved in 2021 while of rest was recovering/resolving.
86 2021-03-03 tremor, hypersensitivity of all senses cold sore; tuned a little red, it was sensitive in the center where the shot went in; tired; arm whi... Read more
cold sore; tuned a little red, it was sensitive in the center where the shot went in; tired; arm which was very sensitive to touch; Shaky; Sore arm, it was sensitive in the center where the shot went in; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982 and expiry date: unknown), via an unspecified route of administration on the left arm, on 27Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medication. The patient experienced, after she pulled put from getting it, she got shaky on 27Jan2021. It went way after about 5 minutes. She gets that when gets a shot for dental work, so maybe it was the same reaction her body does, but it was gone before got home. On 27Jan2021, she had a sore arm for about 4.5 days, and it was difficult to sleep on that arm which was very sensitive to touch, and it turned a little red on 28Jan2021. She noted the soreness that night. She can lay on it now, it was sensitive in the center where the shot went in, but not bad. She was also tired that evening of 27Jan2021. She doesn't know if this has anything to do with it, but she got a cold sore, when she is stressed she gets a cold sore on her lip. This was noted yesterday (01Feb2020). She has medication for it from the doctor, and had to take for 3 days, and it usually clears it up. The cold sore was blistering, but she was susceptible to them with stress, so she was not surprised. Patient recovered from the event of tremor on 27Jan2021, turned a little red on 01Feb2021 and tired on 27Jan2021. Event sore arm was recovering while for the remaining events was unknown.
86 2021-03-07 flushing Patient reported feeling flushed and having difficulty breathing; rapid respiratory response called,... Read more
Patient reported feeling flushed and having difficulty breathing; rapid respiratory response called, patient monitored; no medical treatment needed, was discharged home in vehicle with spouse.
86 2021-03-11 facial pain Starts around 4 pm. Lot of pain right side of face like: 1. toothache, whole jaw aches 2. neck... Read more
Starts around 4 pm. Lot of pain right side of face like: 1. toothache, whole jaw aches 2. neck arthritis 3. sinus infection 4. ear infection all at the same time. Strong pain all through right side of face, sometimes up through eye. Worse lying down. Cause? Dental exam complete mouth x-rays indicated no problems with any teeth. Saw Dr. 3/3/2021, was checked for ear, sinus infections, felt all around my neck, no problems. Prescribed gabapentin, told to continue the Tylenol Arthritis I had been taking on my own. Symptoms continue today, only right side of face, head, temple area, sometimes up through right eye, teeth on right side ache. Only take the Tylenol once a day since that is all that I need it. More painful if I lie down in bed at night so sit upright until pain is gone; then sleep through the night. No problem all during the day when I?m up and around doing whatever. . .no pain then. Someone in my dental office has the same symptoms along with Bells Palsy, was told by her doctor it's from the Covid shot and could last 3 months? Pharmacist also told me filling the gabapentin for several others with same symptoms (I live in a small town).
86 2021-03-18 burning sensation In the afternoon after getting the vaccine she was eating an ice cream bar and had a time trying to ... Read more
In the afternoon after getting the vaccine she was eating an ice cream bar and had a time trying to eat it, it did not go down and it did not go down. She ate dinner and at 10:30 she had terrible burning that went through to her back, had shortness of breath like she could not catch her breath. Her daughter took her to the ER as the pain was so severe she thought she was having a heart attack. In the ER they ran a bunch of tests, did an EKG and took blood, she did not have a heart attack. She was admitted and monitored her. She did have a chest x-ray in the ER as well Nothing showed blood clots in her lungs, nothing in her lungs, but she still had the SOB and the pain went away. She thinks they may have given her some medicine and the pain was gone, but she still was shortness and still is today 3/19/21. She has an appointment next week to have an echocardiogram. She has had check ups with the cardiologist and her PCP since coming home from the hospital. Her PCP gave her an inhaler to use but she has not used it. She did not have any reaction to the injection site itself. Ever since this has happened has had no appetite, brain fog, shortness of breath, fatigue and nothing sounds good to eat She can taste okay, but nothing tastes good to her. She said she doesn't think she can handle this much longer, it's been over a month.
86 2021-03-23 pain in extremity 11 days later, extreme pain in the trapezius muscle/ strain, to the point that arm was useless. Ext... Read more
11 days later, extreme pain in the trapezius muscle/ strain, to the point that arm was useless. Extreme pain radiated from arm to shoulder and neck area, mimicking symptoms of stroke.
86 2021-03-24 involuntary muscle movements, seizure She received vaccine #2 on 02/04/2021. In the wee hours of the morning 02/05/2021, she had at least ... Read more
She received vaccine #2 on 02/04/2021. In the wee hours of the morning 02/05/2021, she had at least two episodes of seizure. she was found gurgling, hypoxic, jerking of arms.
86 2021-03-24 pain in extremity The daughter of the patient stated that her mother is a cardiac patient and has a stent. The patien... Read more
The daughter of the patient stated that her mother is a cardiac patient and has a stent. The patient always has edemas on her legs but the day after the vaccination she observed edema and report pain on the left thigh. The following Monday she visited the MD and he order a venous Doppler. The result was a thrombosis on the right leg . The patient was put on medication (Xarelto)
86 2021-03-25 inability to speak 3/3/2021--called to report an adverse reaction to her 2nd dose of Pfizer COVID-19 Vaccine received o... Read more
3/3/2021--called to report an adverse reaction to her 2nd dose of Pfizer COVID-19 Vaccine received on 2/25/2021. She reports she had extreme pain and achiness on her whole L side (arm she received vaccine in) from her head to her toes. The next morning her daughter called and she had temporary dysphasia (she lives alone and had not tried to speak at all until then). Daughter took her to the Instacare and then the hospital - she stayed at the hospital through the day and received IV fluids and the dysphasia occurred again while there but has not happened again since. LSW, RN.
86 2021-03-29 unresponsive to stimuli Received Vaccine 1/20/21 1/21/2021 Morning: Nursing staff noted decreased O2 Saturation and put her ... Read more
Received Vaccine 1/20/21 1/21/2021 Morning: Nursing staff noted decreased O2 Saturation and put her on an oxygen mask 1/21/2021 Night: Patient found unresponsive, not breathing. DNR. Pronounced Expired
86 2021-04-06 discomfort Body Rash. Both upper arms, lower back, back of legs, mouth. Significant itching and discomfort. Ri... Read more
Body Rash. Both upper arms, lower back, back of legs, mouth. Significant itching and discomfort. Right upper arm developed Cellulitis. Treatment - Cephalexin 500mg, Triamcinolone acetonide 0.025% cream, hydrOXYzine 50mg.
86 2021-04-06 pain in extremity Patient reports mild soreness in her left arm after receiving the vaccine. Reports mild fatigue but ... Read more
Patient reports mild soreness in her left arm after receiving the vaccine. Reports mild fatigue but this was expected due to pharmacy consultation prior to administration. She states she experienced vision loss in her right eye that developed a day or two after receiving the shot. Vision returned in about 24 hours.
86 2021-04-06 pain in extremity Patient reports mild soreness in her left arm after she received the vaccine. She reports mild fatig... Read more
Patient reports mild soreness in her left arm after she received the vaccine. She reports mild fatigue but this was expected due to pharmacy consultation prior to vaccine administration. Reports experiencing vision loss 1-2 days after getting the shot. Vision returned to normal after 1 day.
86 2021-04-08 slurring Per pt's caregiver, pt has been experiencing severe sleepiness/drowsiness following administration o... Read more
Per pt's caregiver, pt has been experiencing severe sleepiness/drowsiness following administration of covid (pfizer) vaccine. Caregiver reports pt is not coherent and presents with slurred speech.
86 2021-04-12 inability to speak, weakness Diarrhea; Vomiting; Weak; Found Slumped Against the Wall; Low Potassium; MRI Found Multiple Small Em... Read more
Diarrhea; Vomiting; Weak; Found Slumped Against the Wall; Low Potassium; MRI Found Multiple Small Emboli in Brain; thrown more clots; Aphasia; Difficulty Walking; potassium dropped and she went into A-Fib and threw clots; potassium dropped and she went into A-Fib and threw clots; has problems with recent memories; confusion; food sensitivities; This is a spontaneous report from a contactable physician (patient's daughter). An 86-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 86-years-old, via an unspecified route of administration on 24Mar2021 at 14:00 at single dose for COVID-19 immunization. Medical history included high blood pressure diagnosed in 1971 (reported as 50 years ago) and ongoing; type 2 diabetes in 2011 (reported as 10 years ago) which resolved in 2019 (about 2 years ago) after the patient lost some weight; she had an episode of A-Fib in 2019 when her potassium was low (lower than the current hospitalization), once the potassium was corrected, her A-Fib resolved. The physician stated that patient has shrunk and was now about 5 foot 2 inches. Clarified that this has not recently occurred since the vaccine; stated it was happening just with age. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not have any issues with the first dose of the vaccine. She received her second vaccine dose on 24Mar2021. The physician spoke with the patient on Friday, 26Mar2021, and the patient was fine. On Saturday, 27Mar2021, the patient had an episode of diarrhea, vomiting and was weak. The lady cleaning the patient's house found her slumped against the wall. The physician met them at the hospital and said the patient seemed okay. They thought it was just an issue from her potassium being low on Mar2021, so they gave her that. The hospital did a CT scan that showed nothing on Mar2021. The hospital did an MRI of the head that showed multiple small emboli in the brain on Mar2021. The physician believed that the patient must have thrown more clots because she became aphasic on Mar2021 and could not name things. The patient also had difficulty walking on Mar2021. The physician felt it was important to call and report this since she has heard of people throwing clots with vaccines. The physician did not know if the events were related to the vaccine. The patient was in the hospital for 7 days (as reported). She was now able to walk with some assistance. The patient's son thought that the patient was okay when he went to see her. Since the reporter was a physician, she knew which questions to ask the patient and saw that she still had some problems. The patient could remember some things but has problems with recent memories on an unspecified date in 2021. She also has some confusion on an unspecified date in 2021, such as she thought she was in a boat hospital. The physician was uncertain if the vomiting and diarrhea was somewhat better. They were wondering if the patient has some food sensitivities (2021). The patient also had carotid studies done in the hospital on Mar2021 and they were fine. They believed that patient's potassium dropped, and she went into A-Fib and threw clots on Mar2021. The clots must have come from the heart valves since the carotid studies were fine and if the clots had been in her legs, they would've gone to her lungs not to her brain. The patient underwent lab tests and procedures which included CT scan: negative, potassium: low, carotid studies: fine, MRI of the head: multiple small emboli in brain, all on Mar2021; and potassium: low, height: 5 foot 2 inches (shrunk), and weight: lost, all on an unspecified date. The events diarrhea, vomiting, weakness and fall required emergency room visit. The outcome of the event difficult walking was recovering and unknown for all other events. The events diarrhea, vomiting, weakness, fall, potassium low, cerebral embolism, thrombosis, and "potassium dropped and she went into A-Fib and threw clots" were assessed as serious due to hospitalization and being life threatening; and the events aphasia and gait disturbance were assessed as serious due to hospitalization. All other events were non-serious. The patient was hospitalized from 27Mar2021 until 02Apr2021. Information about the lot/batch number has been requested.
86 2021-04-12 weakness she felt like her throat was, like somebody was choking her; could not stand; Extreme weakness; Her ... Read more
she felt like her throat was, like somebody was choking her; could not stand; Extreme weakness; Her jaw felt like it was getting huge; Blood pressure went up to 170; Rash on her back; Hives on her legs; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ET7534), dose 1 via an unspecified route of administration on 18Mar2021 (at the age of 86years) as single dose for Covid-19 immunization. Medical history included diabetes mellitus, blood pressure high, multiple sclerosis, and wheelchair user; all from an unknown date and unknown if ongoing. Concomitant medications included ongoing baclofen (10mg, three times a day), metformin (750 mg, twice a day), amlodipine besilate (10mg, once a day), losartan (50 mg, once a day), magnesium (two times a day), metoprolol (50 mg, 3x/day), cyanocobalamin (VITAMIN B 12), and glimepiride (takes 1mg in one meal and as another meal she takes half of a mg); and Statin (unspecified) 10 mg, once a day; all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient received Pfizer Covid vaccine on 18Mar2021 and she did fine but an hour later when she got home, the reporter tried to help her up off of her wheelchair onto another chair and she could not stand. She had extreme weakness and then she felt like her throat was, like somebody was choking her, like their hands around her throat and then her jaw felt like it was getting huge. Then, her blood pressure went up to 170, the patient was given lots of continuous water and blood pressure pill. She started to feel better after that. The reporter further stated, "She has had various different problems. I do not know if it is allergies or what from what she already has but she did have a lot of it and exhausting stuff afterwards. There is mainly that choking feeling that is frightening that she had one hour after". It was also reported that the patient developed some rash on her back and hives on her legs. It was not right away. It was kind of a day or two after. The outcome of events was unknown. Follow-up attempts needed. Further information is expected.
86 2021-04-17 weakness blood pressure systolically reached 170/Blood pressure shot up; blood pressure systolically reached ... Read more
blood pressure systolically reached 170/Blood pressure shot up; blood pressure systolically reached 170/Blood pressure shot up; Felt like someone was choking her; Felt like her jaw was swelling/felt like her jaw was "getting large"; Extreme weakness; Couldn't stand; This is a spontaneous report from a contactable consumer via Medical information team. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 16:30 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing multiple sclerosis , ongoing hypertension, ongoing diabetes mellitus, myocardial infarction from an unknown date and unknown if ongoing stent placed and spasms; and from an unknown date and unknown if ongoing. The patient previously had flu shot and feel a little bit sick, it hit her lot harder with the flu shot. Concomitant medication includes, unspecified, diabetic and hypertensive medication and medication for spasms. On 25Mar2021, 45 minutes to an hour after the patient's first dose, the patient felt like someone was choking her and felt like her jaw was "getting large" without physically getting large. The patient was not able to get out of her wheelchair, even though she was normally able to do so on her own, and her blood pressure systolically reached 170. Her mother was given "excess water" and was given her hypertensive medication "a little early" which caused her pressure to come down quickly. Based on this reaction that her mother had, caller would like to know if it was safe for the patient to receive her second dose of the vaccine. They stayed about 15 min at the drive thru to make sure there was no reaction. It was about a 30-minute drive home with traffic. It happened within the hour, right when she got in the house. The patient had a reaction to the first dose, and the caller wanted to know if it was safe for her to get the second. Within the first hour the patient felt like someone was choking her, she felt like her jaw was swelling, she felt extreme weakness and could not stand, and her blood pressure shot up. It shot up to 170, but she did not know the diastolic. The patient felt like she was choking so she was doused with water to push anything through in case that would help. Within a couple of hours, the patient started to feel better. They gave her excess fluids and gave her blood pressure medication a little bit earlier and everything came back down. She was frightened when this first occurred. The feeling of choking and the feeling of jaw swelling got better and went away within a few hours. The patient had multiple sclerosis so weakness is always an issue and mobility is always an issue. She knew her tolerance and what she could do. That day they had taken her in a wheelchair from the car to the house and she could not get out of the wheelchair, which was not normal for her. This happened within an hour of the shot. The weakness lingered the longest. That side effect did linger. It took a couple of days. She was using a Hugo again to get herself around the house and believes this extreme weakness has gone away. She was exercising on a stepper when the caller was talking to her. Caller did not believe there had been any lasting effects. Blood pressure shot up: Started within an hour of the vaccine. She had been hypertensive for quite some time historically. Her medication had been keeping it under control. They administered her dose early that day and it brought it down, it did not linger. The patient had been housebound since the pandemic started. The outcome of the event blood pressure shot up was recovering, while the outcome of the event couldn't stand was unknown; and the outcome of the rest of the events was recovered on 25Mar2021. Information on lot/batch number has been requested.
86 2021-04-20 weakness Severe abdominal cramps, HR down to 28, BP would not register for 3-5 minutes, then HR increased to... Read more
Severe abdominal cramps, HR down to 28, BP would not register for 3-5 minutes, then HR increased to 40and BP 100/41, nausea and vomiting, temp of 102, extreme weakness for 2-3 days. Cardiology f/u appt end of week was satisfactory.
86 2021-04-20 weakness headache, chills, weakness, nausea the day after - progressed to severe abdominal pain, vomiting bil... Read more
headache, chills, weakness, nausea the day after - progressed to severe abdominal pain, vomiting bile, bloody diarrhea on day 2.
86 2021-04-21 unresponsive to stimuli 4/21/21 ER hpi: 86 y.o. female who presents with unresponsive episode. Patient is a resident of a n... Read more
4/21/21 ER hpi: 86 y.o. female who presents with unresponsive episode. Patient is a resident of a nursing home and was apparently talking to members of her family when she collapsed prior to arrival several minutes ago. Paramedics report patient hypotensive on arrival to scene. Blood pressure and level of consciousness have improved during transport. Patient is hypertensive and is on multiple medications. At this time she has no complaints and states she feels all right. She does have a history of multiple recurrent urinary tract infections. Admitted observation to hospital 4/21/21 dx syncope and collapse, positive d-dimer, acute uti
86 2021-04-29 brain damage, weakness This 86 year old female received the Covid shot on 2/07/21 and went to the ED on 2/12/21 ... Read more
This 86 year old female received the Covid shot on 2/07/21 and went to the ED on 2/12/21 and was admitted on 2/13/21 with a cerebrovascualar accident, weakness, encephalopathy and UTI and went to the ED a 2nd time on 2/24/21 and admitted on 2/26/21 with and went to the ED again on 3/22/21 with altered mental status and died in 4/2021. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.
86 2021-05-03 weakness Patient with no reported past medical history or past surgical history presented to ED and found to ... Read more
Patient with no reported past medical history or past surgical history presented to ED and found to have massive bilateral pulmonary embolism. Upon presentation, patient was confused and lethargic. The morning of the event, niece reports that patient was in her usual state of health this am and had gone downstairs to the kitchen this afternoon, when she was downstairs she began complaining of nausea and generalized back pain. Her niece went to grab her things to take patient to the hospital but when she returned she found the patient laying on the floor due to weakness and pain, no reported fall or trauma. Chest/Abd/Pelvis CT Angio was significant for large PE in R and L main pulmonary arteries. No family history of DVT/PE.
86 2021-05-05 weakness, inability to speak Same day as when patient received the 2nd vaccine, she was overcome with generalized fatigue and nau... Read more
Same day as when patient received the 2nd vaccine, she was overcome with generalized fatigue and nausea. By the 4th day, her legs would not hold her when she tried to stand getting out of bed. She was nauseous to the point of not being able to eat or drink. Infact, she did not have the strength or desire to eat or drink. By the 5th day post vaccine (02/20/21), I took her to the Emergency room because she was so fatigued, she just slept, and couldn't stay awake to eat or drink. She was able to get to the car with a walker, but that was the last time she walked. After time at hospital and then Skilled nursing, she passed away on 03/21/21. She never regained the ability to toilet herself, eat on her own, failed to eat and drink, and eventually was put on hospice because she lost 30 pounds over the month from failure to eat or drink, even though I was there or the nurse was there to feed her every meal, and try to get her to take fluids. Her fatigue was just overwhelming. When she first arrived at the emergency room, she: ? Presented with 2 days of weakness and AMS; fever, nausea and generalized fatigue ? Word finding difficulty; without stroke or acute abnormal on CT or MRI; according to the Hospital
86 2021-05-05 cold sweat Redness & swelling at injection site; Redness & swelling at injection site; Dizziness; Hot & cold sw... Read more
Redness & swelling at injection site; Redness & swelling at injection site; Dizziness; Hot & cold sweats; Hot & cold sweats; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 30Mar2021 (at the age of 86-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date as a single dose for COVID-19 immunization. On the second or third day after receiving the vaccine, the patient experienced redness and swelling at injection site, dizziness, hot and cold sweats. The event were reported as non-serious. The outcomes of redness and swelling at injection site, dizziness, hot and cold sweats were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
86 2021-05-07 pain in extremity swelling in right hand; right hand pain; right hand pain worsened; This is a spontaneous report rece... Read more
swelling in right hand; right hand pain; right hand pain worsened; This is a spontaneous report received from a contactable consumer. The consumer reported for an 86-year-old female patient (mom) that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, and Lot Number: EL9269) intramuscularly administered in right arm on 09Feb2021 11:30 as single dose for COVID-19 immunization. The patient medical history included atrial fibrillation (diagnosed about 15-20 years ago, more like 15 years), thyroid, blood pressure, and for heart issues, sinus issues, cholesterol and arthritis all are ongoing. Concomitant medications included atorvastatin, fexofenadine hydrochloride (ALLEGRA), levothyroxine, metoprolol tartrate, spironolactone and warfarin. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, and Lot Number: EL3249 or EL2249) intramuscularly administered in right arm on 19Jan2021 11:30am as single dose for COVID-19 immunization and She has been getting the flu vaccine for years. On 10Feb2021, the patient experienced pain in her right hand, she got the vaccine shot in her right arm. On 10Feb2021, the right hand pain was reported as worsened. On an unspecified date, the subject noticed swelling on her right hand, the patient did not think she had the swelling before. It was reported that the swelling was not huge, but it was troublesome, and the patient had to take her coffee with her left hand. It was reported that it had just been 36 hours after the patient had the injection and she was still experiencing the pain. Around 9 or 10 last night her mom was complaining, and she wonders if it happened because of the injection. The patient did not experience injection site swelling. The patient did not take any treatment she was just resting. The outcome of events right hand pain and right hand pain worsened was not recovered and swelling in right hand was unknown.
86 2021-05-11 muscle spasms Patient developed symptoms of bilateral posterior chest wall pain 2 weeks after the second dose, res... Read more
Patient developed symptoms of bilateral posterior chest wall pain 2 weeks after the second dose, resolved after 2-3 days, also cough, runny nose 4 weeks after vaccination( chest CT scan showed multiple nodules)then had left leg cramps, 5 weeks later developed severe left and then posterior pleuritic pain had CT A PE study with small bilateral pulmonary emboli.
86 2021-05-13 weakness At 11: 53 AM Client sitting in observation area c/o "a little dizzy, i feel hungry." 11:55 am cookie... Read more
At 11: 53 AM Client sitting in observation area c/o "a little dizzy, i feel hungry." 11:55 am cookies and water given to client. Client ate a few bits. Vitals check: BP 180/90, 75 bpm, 97%, 16 RR. 11:58 Vitals check: 210/100, 78 bpm, 96%, 16 RR. 12:00 pm Client c/o sudden urge to have a BM and stated, "I need to move my bowels." Escorted by PHN and caregiver at 12:05 pm to nearest restroom. Client walked with steady gate using walker. 12:20 pm Client returned to observation area, reported a loose BM. Stated abdominal pain resolved after using the bathroom. Continues to C/o dizziness and now weakness. Client A x O x4 Vitals check 12:20 pm 230/100, 87 bpm (pulse regular per palpitation), 97%, 19 RR. Client continues to eat cookies given. Vitals check 12:20 pm: 190/90, 79 bpm, 97%, 18 RR. T.C. to 9-1-1 at 12:28 pm. At 12:30 pm client states not feeling dizzy anymore, just tired, wanted to lie down. At 12:31 pm PHN called lead RN, advised to give Benadryl per protocol. 12:34 pm Benadryl given PO. 12:45 pm Vitals check: 190/90, 75 bpm, 98%, 16 RR. EMS arrived and assumed care at 12:50pm. Client signed Against Medical Advice at 1:36 PM. PHN educate need to follow up in 24 hours with PMD clinic, educated risks of elevated BP and possible adverse reactions to vaccine. At 1:38pm Client walked off with stead gait with caregiver.
86 2021-05-14 pain in extremity tired; sore arm; This is a spontaneous report from a contactable consumer. An 86-years-old female pa... Read more
tired; sore arm; This is a spontaneous report from a contactable consumer. An 86-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN, Expiration date: UNKNOWN), via an unspecified route of administration on 13Feb2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient had no medical history and concomitant medications were reported. The patient did not take any other products. On unspecified date of Feb2021, the patient experienced tired and sore arm. Patient states he just has a question, states he works in health care, in administration. States he was vaccinated with the Pfizer vaccine and his mother received her first dose of the Pfizer Covid vaccine on Saturday, 13Feb2021. Patient states they gave her an appointment date for the follow up, her second dose is scheduled 18 days after the first dose as opposed to the recommended 21 days. Patient stated he had his second dose at 20 days after the first and the provider told him it was fine. Wants to make sure that it was okay if she gets her second dose at only 18 days after the first, cannot find any information about this. States she has had no serious issues after the first dose, states she was tired after first dose but unsure if that is related to the vaccine, did have somewhat of a sore arm. The outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information was expected.
86 2021-05-15 pain in extremity On April 25 did not feel well the next day had neck and shoulder pain and muscle muscle pains in arm... Read more
On April 25 did not feel well the next day had neck and shoulder pain and muscle muscle pains in arms and then the the muscles in the right upper arm did not function properly and lost mobility yes. At timesAt times had to support my right arm in order to lift it above my head or move it side to side there was some pain in the right arm. There has been improvement but still a lot of mobility lost.
86 2021-05-16 weakness Presented to emergency department on 5/15/21 with weakness, lethargy, and increased confusion with o... Read more
Presented to emergency department on 5/15/21 with weakness, lethargy, and increased confusion with onset approximately 4 to 5 days ago. She had a positive COVID exposure prior to presentation. Patient was admitted for further management of COVID-19 infection and acute kidney injury. Patient is admitted at time of writing.
86 2021-05-19 pain in extremity, sciatica, muscle spasms blood clot; Sciatica; She then got sciatica in her leg and couldn't walk; charley horse in her lower... Read more
blood clot; Sciatica; She then got sciatica in her leg and couldn't walk; charley horse in her lower leg while walking; soreness in arm / pain in her foot / lower leg/calf still hurt; This is a spontaneous report from a contactable nurse (patient). This 86 years old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6203) on 04Mar2021 at 11:00, in left arm, for COVID-19 immunisation. No other vaccines were administered on the same date. The patient received the first dose of BNT162B2 vaccine intramuscular, on 11Feb2021 at 18:30 (lot EN6201). The patient received some years ago an unspecified pneumonia vaccine and an unspecified tetanus vaccine experiencing after both headache, swollen arm and rash. She didn't react to the flu vaccine. Her body didn't want any more vaccine. Concomitant medications were none. On an unspecified date in Mar2021, maybe a week or two after the second vaccination, early to mid afternoon, the patient had what felt like a charley horse in her lower leg while walking, but didn't pay any attention to it, just put ice on the leg. She then got sciatica in her leg on 24Apr2021 and couldn't walk; that was what sent her to the hospital as it was getting worse and she went to the hospital because of the pain. She just ignored it for at least a week but she was still having pain after the second week and could hardly walk due to the sciatica in that leg. At the hospital they found she had a blood clot in the calf of her leg on 28Apr2021. She was hospitalized from 28Apr2021 to 02May2021. The doctors in the hospital recommended that she should report her experience even though they didn't know if it was due to the COVID vaccine due to the proximity. The hospital doctors took care of her but her primary care provider knew that she had been in the hospital. The doctors gave her medications in the hospital that helped the pain in her foot and the sciatica but her lower leg/calf still hurt so they decided to do an ultrasound and found a blood clot. The patient still had to give herself injections in the belly for blood thinner to treat the blood clot. The patient also experienced soreness in arm on an unspecified date in 2021. Sciatica required ER visit. Blood clot was resolving. The other events outcome was unknown. The doctor said that there was a possibility that the blood clot could be related to the COVID vaccine, but it may not be related at all.; Sender's Comments: Based on the information provided by the reporter, including a prolonged onset latency of nearly two months, it appears unlikely that BNT162B2 contributed to the reported events. These are likely intercurrent medical conditions in this elderly patient. This case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) :PFIZER INC-2021501847 same patient/drug, different vaccine dose/AE
86 2021-05-20 nerve pain, pain in extremity, weakness, numbness and pain in extremities The day after the first shot, my mother had bad knee pain in her left knee. It went on for days/week... Read more
The day after the first shot, my mother had bad knee pain in her left knee. It went on for days/week. After the second dose, days out she started feel very tired and bad pain in her feet that went to her hands and she couldn't get out of bed or urinate properly. Her facility doctor gave her Gabepentin for the pain but it did not help. She declined over a week or so and then She was admitted into the hospital for dehydration (March 19, 2021). The put a catheter in her to get urine out and bring her kidney function back to her normal (she does have kidney disease). Gave her more Gabepentin (which does not help pain in feet an hands) and released her to rehab. and she is now on oxygen. Rehab was bad so I got her out and released to her facility so she could receive rehab there. She declined again with the same reaction: extreme fatigue, can't walk and now urinates and defecates in an adult diaper and now breathing is very labored. She was admitted to the hospital and they can't find out why she is in this way. They did blood work, tests, scan and X-rays without any answers. They switched up meds on her and then released her to rehab since she hasn't walked in weeks/month at this point. She is regaining strength but now on oxygen even when sitting. She is 86 and walked with a walker all around her facility and when going to doctor appointments. Now she is in a wheelchair for doctor appointments since she has no strength and needs oxygen to walk. Her facility saw her decline after the second shot and my mom is very vocal and each day told them how she felt awful and it is because of the shot. She still has neuropathy in her feet and hands but it is not as painful as it originally was and it peaked and now just painful about a 5-6 on a scale of 0-10.
86 2021-05-24 pain in extremity Starting day after vaccine: pain shoulders, arms, legs;. After couple weeks, tried ibuprofen, then... Read more
Starting day after vaccine: pain shoulders, arms, legs;. After couple weeks, tried ibuprofen, then etodolac. Finally, doctor diagnosed possibly polymyalgia rheumaticas symptioms and prescribed 10 days of prednisone 20 mg. Prednisone relieved pain and returned to normal range of movement. But last pill yesterday, so must see if pain returns. Problem has continued from March 12 to today. Pain was extreme: very difficult to walk stairs, get out of bed, etc.
86 2021-05-25 weakness COVID 19 test POSITIVE Patient's husband was notified of positive test results from test complete... Read more
COVID 19 test POSITIVE Patient's husband was notified of positive test results from test completed on 5/2/21. Stated patient was sleeping at this time, but she is already aware of the diagnosis. Signs and symptoms: 1. When did your symptoms start? 5/2/21 2. What symptoms have you experienced? Diarrhea, weakness, upset stomach. Close contact questions: 1. # in household: 2 2. Have you been in close contact with anyone two days before symptoms including going to work while you were sick? Yes
86 2021-05-28 tingling Severe headache later feel like I had relate to my teeth ache; Severe headache later feel like I had... Read more
Severe headache later feel like I had relate to my teeth ache; Severe headache later feel like I had relate to my teeth ache; I got the funny hot kind, shoot through my whole body; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration on 26Feb2021 (age at vaccination 86-year-old) at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included diltiazem. It was stated, "patient got her first Covid shot yesterday (clarified as 26Feb2021) afternoon and last night, on an unspecified date in 2021, she got had a severe headache later feel like she had relate to her teeth ache, but then later in the, patient got the funny hot kind, shoot through her whole body, it was like when she had up her surgery, when they put dye (further not clarified) in her she feel hot and now that she get it few times, the 4 o clock this morning and she got it again and now what she had all and got it in her back, was this severe allergies or otherwise she was okay." When paraphrased the concern, consumer confirmed the same and stated, "Yes, you are correct its shooting hot like it was hard to explain that it get real kind of hot and it was going through her whole body, not all the time." It was stated, "she was on medications for Blood pressure." The outcome of events was unknown. Follow-up attempts completed. No further information expected.
86 2021-05-31 pain in extremity, weakness very fatigued; pain in her feet moved up to her hands; she couldn't walk; she was bedridden; could n... Read more
very fatigued; pain in her feet moved up to her hands; she couldn't walk; she was bedridden; could not urinate properly, she couldn't void all the way; Incontinent; breathing was labored; she had no strength at all; This is a spontaneous report from a contactable consumer (patient's daughter). An 86-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 86 years old on 17Feb2021 (Lot number EL3302) received in her arm at single dose for COVID-19 immunization. Ongoing medical history included Low functioning kidney for probably 15 years, Platelete condition for probably 20 years, COPD since she was in her 40's, Asthma for over 40 years, Chronic heart failure for 10 or more years, high blood pressure, acid reflux, allergies, retains water, neuropathy in hands and feet, mucous in the lungs, thyroid condition, hypo for more than 20 years, bad lower back and bad left shoulder, nerves, anxiety, to sleep, to calm her nerves, walked with a walker. Concomitant medications included amlodipine ongoing for high blood pressure; ascorbic acid (VITAMIN C) ongoing; acetylsalicylic acid (ASPIRIN) ongoing for heart condition; atorvastatin ongoing; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) ongoing for asthma, COPD; buspirone ongoing; carvedilol ongoing; clotrimazole; famotidine ongoing for acid reflux; ferrous sulfate from an unspecified date to Apr2021 as Iron supplement; fluticasone propionate ongoing for allergies and asthma; fluticasone, salmeterol ongoing; folic acid ongoing; furosemide ongoing for retains water; gabapentin from Feb2021 and ongoing for neuropathy in hands and feet; guaifenesin ongoing for mucous in the lungs; hydroxyurea ongoing for her bone marrow made too many platelets; levothyroxine sodium ongoing for thyroid condition, hypo; lidocaine hydrochloride (LIDOCAINE) for bad lower back and bad left shoulder; magnesium oxide (MAG-OX) ongoing; montelukast for allergy and asthma; sertraline hydrochloride (ZOLOFT) ongoing; sitagliptin ongoing; temazepam for nerves and anxiety; linagliptin (TRADJENTA) ongoing; trazodone ongoing to sleep, to calm her nerves; valsartan for high blood pressure; vitamin D. Historical Vaccine included first dose of BNT162B2 (Lot number EK4176) on 27Jan2021 received in one of her arms for COVID-19 immunization and experienced severe pain in her left knee. The patient received the second vaccine on 17Feb2021. A week out or so she started having pain in her feet and she was very fatigued 19Mar2021; both still ongoing, both on a week. The patient had had 2 stints at the hospital, and 2 rehabs. Both of these have very slightly improved. The patient went to the hospital due to the pain in her feet that moved up to her hands, she was very fatigued, and she couldn't walk; she was bedridden on 19Mar2021. Weeks after the shot it continued day after day after day up until 19Mar2021 where she was admitted to the hospital. The patient just had her last stint in rehab this past 2 weeks and could get up with physical therapy. Hospitalization was from 19Mar2021 to 27Mar2021. The patient could not urinate properly, she couldn't void all the way and that this occurred some time between after the second vaccine up until 19Mar2021. Those few weeks things progressed. Now she was incontinent and had to wear diapers. She urinates in diapers and defecates in diapers. The incontinence started sometime during 19Mar2021 to 27Mar2021 and it is ongoing, persisting. In the hospital they could not find anything seriously wrong with her. The patient had total fatigue and the caller begged them to give her mother a (vitamin) B12 shot. They gave it to her but there was no improvement with patient's energy. They put a catheter in her to get her kidney function back to her normal level. It was because she was not urinating properly. They ran a bunch of tests and there was not anything wrong with her. They did cardiac tests, lung tests, and XRays. The patient's breathing was labored. Started sometime after the second shot leading up to the hospital and that the patient had to be on oxygen. She said she was still on oxygen and that the labored breathing was ongoing, persisting. Reporter said all of these above listed were from 25Apr2021 to 03May2021. They did more tests but there were no answers and patient was at this point bedridden all this time; she had no strength at all, all the same symptoms were ongoing, there were no diagnoses, they were switching her meds around. The patient was on oxygen 24/7, all day when she was walking, sitting in a room in her wheelchair. The caller said she was hoping patient could get up and walk around but she was still weak. She said with time she hoped she got better on feet, got back to her normal. The outcome of the events were not resolved. Information on the lot/batch number has been requested.
86 2021-06-01 burning sensation After 4 hours after first vaccine had redness and burning in face and skull (4/21/21) was date of fi... Read more
After 4 hours after first vaccine had redness and burning in face and skull (4/21/21) was date of first vaccine), it resolved in the afternoon 4/22/21. June 1, 2021, which was 20 days after her second vaccine., she facial redness and burning sensation sensation on face. Noticed that her forehead was hot.
86 2021-06-03 pain in extremity Arm sore; Joint pain all over my body; Bad headache; Nauseated; This is a spontaneous report from a ... Read more
Arm sore; Joint pain all over my body; Bad headache; Nauseated; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Concomitant was not reported. On an unspecified date, the patient reported that she had Pfizer shot yesterday at 9:00 o'clock and she did not felt that day and later in the evening at 8:00 o'clock, her arm was really sore and she continued to have joint pain all over the body and had a bad headache and nauseated. She wanted to know that she can take Anacin or Tylenol or Dramamine because she got a bad headache and nauseated. When probed for vaccine details, consumer stated, "The one we got yesterday. I am 86 and I don't know why I am feeling like this (headache and nauseated). My husband was trying to help me here. We both got this one but he has a joint pain but now I have (incomplete sentence). They gave 2 little card and they said come back the 26th of this month. All I see on this just little card. (name) , I don't know what else is here, it says CBC in the corner. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
86 2021-06-15 pain in extremity Ulcer pain since I got the shot; Cant walk anymore, the pain is in my legs, in my feet, in my arms, ... Read more
Ulcer pain since I got the shot; Cant walk anymore, the pain is in my legs, in my feet, in my arms, I cant walk anymore; the pain is in my legs, in my feet, in my arms/fingers hurt; I had diarrhea and I had to throw up; I had diarrhea and I had to throw up; back hurts; all my bones are hurting; This is a spontaneous report from a contactable consumer (patient). This 86-year-old female patient received 1st dose of BNT162B2 (lot# ER8732) at the age of 86 years old, on 26Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. Patient experienced Ulcer pain since got the shot. Cant walk anymore, the pain is in her legs, in her feet, in her arms (if take a pain killer it do not work). She cannot drive car nor go no places. Also Diarrhea, Had to throw up. Since I got this shot the first day I got, for 4 days I had diarrhea and I had to throw up, well I have never seen this in my life because when I throw it up it was (not clear), it was like two. Now I got this shot on 03/26 and now I am in ulcer pain, I cant walk, all my bones are hurting, I cant drive my car anymore, I cant go no place. I am 86 years old and all by myself. I dont know what to do I am in pain. My leg hurts I hardly can walk, my back hurts, my arms hurt, my fingers hurt. I dont know what I have to do. I am 86 years old and I live by myself and I dont know what to do. The first shot I got was on (03/36) and I had no problem with this one, but the second one I got is killing me (refer to AER#2021630678)." Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.
86 2021-06-17 weakness Admit 6/12 for weakness, SOB, acute on chronic HF. CXR shows interstitial lung dx not COVID PNA, WB... Read more
Admit 6/12 for weakness, SOB, acute on chronic HF. CXR shows interstitial lung dx not COVID PNA, WBC WNL. Minimally symptomatic, mildly hypoxic. Treated w/abx and steroid, Vit C. Pt DC'd back to SNF on RA.
86 2021-06-22 burning sensation One time: woke up day after vaccine very lethargic. Many time: Parts of my body turn red and feels... Read more
One time: woke up day after vaccine very lethargic. Many time: Parts of my body turn red and feels like 'on fire' - even today having an episode.
86 2021-06-24 weakness Difficulty breathing; Pain at the injection site; Tired; Muscle pain; Chills; Joint pain; feeling ve... Read more
Difficulty breathing; Pain at the injection site; Tired; Muscle pain; Chills; Joint pain; feeling very weak; At the injection site she had swelling and redness that went down her arm that lasted 2 weeks.; At the injection site she had swelling and redness that went down her arm that lasted 2 weeks.; She felt a little pain; rash or redness; Got the sweats after the chills; having weakness in her legs, the muscles and joints.; Having weakness in her legs, the muscles and joints.; This is a spontaneous report from a contactable consumer (patient). A 86-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EWO162), dose 1 via an unspecified route of administration, on 22Apr2021 13:00 as 1st dose, single (at the age of 86-years-old) dose on left arm for COVID-19 immunization. Medical history included prosthesis on the right arm 7-8 years ago, that is why she gets everything done on the left arm. And got COVID-19 virus, then she got the antibodies intravenously applied. The patient's concomitant medications were not reported and she would rather not give her list of medications. On 22Apr2021, after vaccination, the patient had reaction. The patient also had pain at the injection site injection, site swelling and redness that went down her arm, was tired, had muscle pain, chills, joint pain, difficulty breathing and weakness in joint. After getting the shot she felt a little pain, then a rash or redness that kept growing and growing; she felt it was little swollen. The patient stated that she got so chilled she had to put on 4 layers of clothing and 2 blankets. Then she got the sweats after the chills, so much that you could wring it out of her clothing. She reports feeling very weak and had the chills, then she went to bed and woke up with the sweats. The patient also having weakness in her legs, the muscles and joints. It was reported that everything went away after about a week, gently. At the injection site she had swelling and redness that went down her arm that lasted 2 weeks and went away. The patient furthermore stated that "she is not going bald but, losing her hair a little and the color of her hair changed from dark brown to all white now, it happens when one gets old they shrink, go bald or lose your hair". The patient was scheduled to receive second shot on 12May2021 at 11:00. She went to her pulmonary doctor due to having trouble breathing. They increased her medication for her breathing which helped a lot. Therapeutic measures were taken with medications for dyspnea. The patient recovered from all the events. No follow-up attempts are needed. No further information is expected.
86 2021-06-26 unresponsive to stimuli, seizure Eyes roll back and she looked like she passed out and then she looked like she started having a seiz... Read more
Eyes roll back and she looked like she passed out and then she looked like she started having a seizure. Then she stiffened and would not respond. This lasted for about 2 minutes. Then for 10 minutes after she felt very drained and disoriented.
86 2021-06-30 weakness, discomfort, pain in extremity patient is very confused; arm hurting; body pain; fatigue; uncomfortable feeling; fell; sick; fell a... Read more
patient is very confused; arm hurting; body pain; fatigue; uncomfortable feeling; fell; sick; fell asleep; unconscious; vomited all over herself; urinary tract infection; 'weakened state'; muscle aches; This is a spontaneous report from a contactable other hcp. A 86-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Jun2021 (at the age of 86-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Jan2021 to Feb2021, callers mother had covid back in Feb2021. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 16Jun2021 11:00 wednesday, the patient was found unconscious in the living room floor by a neighbor, had vomited all over herself, her arm hurting, muscle aches, body pain, very weak, was diagnosed with a UTI and patient was confused on an unspecified date. She has since been discharged home, is in a weakened state and was advised not to get the 2nd shot. Caller concerned that 2 individuals came over to her mothers house to administer the vaccine. Patient was advised no to receive the second dose Pfizer Covid 19 Vaccine by the doctor. Yesterday (16Jun2021), the caller's mother ended up in the emergency room with an adverse reaction: clarified her mother was discharged from the emergency room. The patient arm was still hurting. When asked if the arm hurting is improved, worsened or persisting, the caller replies it is probably about the same. Stated she was informed on Tuesday evening 15Jun2021 that an individual came to her mother's home and administered the first dose Pfizer Covid 19 Vaccine to the patient. The caller said she spoke to her mother at 11:00 on Wednesday 16Jun2021, had an uncomfortable feeling that someone came to her mother's home and administered her mother the first dose Pfizer Covid 19 Vaccine. At this time on 11:00 on Wednesday, 16Jun2021 was when the caller mother told the caller about her symptoms. The caller clarified the mother's symptoms all began less than 24 hours after the mother received the first dose Pfizer Covid 19 Vaccine. Patient has fatigue, body pain is persisting and being very weak is persisting. The caller has reached out to the doctor and had tried to get home healthcare in to help her mother get her strength back up. The caller said when her mother had come to with the neighbor, her mother said she was in the kitchen and fell and crawled into the living room and that was when the patient got sick all over herself. The caller mother just fell asleep and the caller believed her mother was unconscious at that point. Time the Vaccination was given in mid-afternoon. Patient was on the fence about receiving the Pfizer Covid Vaccine. Patient antibodies were probably just as good as the Pfizer Covid 19 Vaccine. Due to the patients age, she was capable of handling any possible side effects from the Pfizer Covid 19 Vaccine. The patient went ahead and set up to receive the Pfizer Covid Vaccine.The patient underwent lab tests and procedures which included blood test: normal, chest x-ray: normal on 16Jun2021. Events resulted in emergency room visit. The seriousness of unconscious was medically significant. The outcome of all events were unknown. Information on Lot/Batch number has been requested.
86 2021-06-30 pain in extremity Twisted her knee a little bit/folding chair came down and slammed down onto her knee; Deep bruise; c... Read more
Twisted her knee a little bit/folding chair came down and slammed down onto her knee; Deep bruise; could only remember the itchy thing; problem with her knee on left side; Weakness to right arm; Arm just reacted strangely, ache, hurt like a toothache just where the vaccine had been placed; Arm just reacted strangely, ache, hurt like a toothache just where the vaccine had been placed; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021), via an unspecified route of administration, administered in arm right on 18Feb2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9265, Expiry: 20May2021), dose injection to right arm, not too high up on the shoulder. The patient experienced calling to report pain, weakness to right arm, twisted her knee a little bit/folding chair came down and slammed down onto her knee, deep bruise, she hasn't gotten the vaccine for shingles, could only remember the itchy thing, problem with her knee on left side on an unspecified date, second dose hurt when it went in on 18Feb2021, arm had also sort of lost the strength in it too on an unspecified date in Mar2021, arm just reacted strangely, ache, hurt like a toothache just where the vaccine had been placed on an unspecified date in Mar2021. Patient reported that there is a dot where the second dose needle went in her arm. She do not have COVID so assumed she should get it so they could keep living. After the first dose she do not even feel anything, had no reaction to that. The second dose hurt when it went in, but she thought it would go away. So for about 3 weeks she was fine after that. Starting on unknown date in Mar2021, about 3 weeks after she was administered the second dose her arm just reacted strangely, ache, hurt like a toothache just where the vaccine had been placed. It continued that way. Her arm had also sort of lost the strength in it too which still was not returned totally. Events are ongoing, still every once in a while would come back like a toothache; people say it would go away. She asked the expected duration of events; and if potential third dose is or is not recommended relative to events. Patient thought she was about 5 feet and keeps getting shorter, used to be more than 5 feet tall. But she vacuums, moves things around, trying to do what she should do; but events are continuing and she just wondered how long it would continue yet before it went away. Doctor said they would get a third dose of the Pfizer Covid-19 Vaccine, and she do not know whether she should relative to these events. The reason she got the Pfizer Covid-19 Vaccine doses in the right arm is because 2 years ago when she got the flu shot patient had a reaction where site was very red; so she thought she was not going to get injection in the left arm again because she is left handed. She knows that not supposed to get other vaccines, so she has not gotten the vaccine for shingles. The harder she tries to remember the worse it is, then she remembered vaccine for shingles. The physician put cortisone in her shoulder because he said it was something else, that he really do not think it was from the shot. She thought well she has had no accident, no fall, no bang, nothing to produce this other than the shot. He looked at it and gave her some exercises to do, so she was going to continue with therapy at the clinic; she goes to see the lady next week. Before all this happened it was going on and on and on. She had a problem with her knee on left side which the doctor looked at during that appointment. After the Pfizer Covid-19 Vaccine was administered, about 6 weeks ago she was working out in the yard. She do not think it had anything to do with the vaccine. The patient underwent lab tests and procedures which included x-ray: unknown results on unspecified date. Therapeutic measures were taken as a result of calling to report pain, weakness to right arm, second dose hurt when it went in, arm had also sort of lost the strength in it too, twisted her knee a little bit/folding chair came down and slammed down onto her knee, deep bruise, arm just reacted strangely, ache, hurt like a toothache just where the vaccine had been placed, arm just reacted strangely, she hasn't gotten the vaccine for shingles, could only remember the itchy thing, problem with her knee on left side. The seriousness of the events was medically significant. The clinical outcome of arm had also sort of lost the strength in it too, deep bruise were recovering, of the arm just reacted strangely, ache, hurt like a toothache just where the vaccine had been placed were not recovered, of the calling to report pain, weakness to right arm, hurt when it, second dose hurt when it went in, twisted her knee a little bit/folding chair came down and slammed down onto her knee went in, she hasn't gotten the vaccine for shingles, could only remember the itchy thing and problem with her knee were unknown.
86 2021-07-05 unresponsive to stimuli, weakness Daughter stated that patient got very weak about a week after the 2nd dose of pfizer vaccine. Daugh... Read more
Daughter stated that patient got very weak about a week after the 2nd dose of pfizer vaccine. Daughter also stated that patient was taken to ER bc she was unresponsive and her blood pressure was dropping, patient passed at ER on 05/19/2021
86 2021-07-06 feeling cold, burning sensation, tremor, weakness Experiencing a heaviness in her chest; jaw pain; like she is freezing outside; she could barely walk... Read more
Experiencing a heaviness in her chest; jaw pain; like she is freezing outside; she could barely walk with her walker; severe nausea; shaking from head to toe/having tremble; felt like burning up inside; Weakness; Has zero appetite; Anxiety.; This is a spontaneous report from a contactable consumer (daughter). This consumer reported for an 86-year-old female patient that: An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 27Apr2021 at 11:00 (at the age of 86 year) as single dose for covid-19 immunisation. Medical history included Chronic hives from an unknown date and unknown if ongoing, ongoing Unspecified reactions, ongoing Unspecified medication allergies and patient had a prior fall where she suffered a broken ankle. Concomitant medication(s) included dupilumab (DUPIXENT) taken for eczema from Sep2020 and ongoing and latanoprost (LATANOPROST) taken for glaucoma from an unspecified start date and ongoing. Patient historical vaccine includes shingles vaccine for immunization and within 48 hours, the patient broke out in severe eczema from head to toe and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP7533), via unspecified route of administration on Right arm for Covid-19 immunization and experienced no adverse event. She had Called on behalf of her mother who was 86 years old. Mother received the second dose of the Pfizer BioNTech Covid-19 vaccine last 27Apr2021, within 24 hours, mother experienced severe nausea with shaking from head to toe and felt like burning up inside. The weekend after the second dose, the mother experienced heaviness in the chest and jaw pain and was brought to the ER. Full cardiac work up was done, and results were fine. Doctors said this may be due to anxiety. Mother had CT abdomen, an endo scan, and blood works but they were all fine. Mother continues to weaken, having tremble and is nauseous. These symptoms would come and go. Mother was in the ER twice this past week and they could not find anything. Nausea got worse. It would come back strong around 3:30 in the morning. Caller wanted to know if these were reported with the Pfizer Covid-19 vaccine and if there was anything they could do further. Mother was taken to different doctors and tests were done but no findings. caller mentioned that the symptoms happened right after the shot. She reported that the patient has been seeing an infectious diseases doctor as during her lifetime, the patient has always had chronic hives. Caller reported that the patient has reactions to many things and is allergic to many medications. She reported that that weekend it got so severe, the patient was experiencing a heaviness in her chest and jaw pain. She reported that they thought the heaviness in the patient's chest and jaw pain might be cardiac, so the patient was taken to the emergency room. She reported that the patient stayed 2 nights in the hospital. Caller reported that the patient's heart was ruled out and her bloodwork came back ok. Caller reported that the hospital physicians thought that the heaviness and jaw pain could be anxiety and prescribed anxiety medication for the patient. She reported that the patient went to her primary care physician after leaving the hospital. Caller reported that the patient got worse and was experiencing nausea more and more. She reported that the patient's physician ordered an endoscopy and brain scan to rule out everything medically. Caller reported that the patient's physician informed her that her blood pressure was fine, her bloodwork was fine, and that all of her test results were normal. She reported that the patient just continues to weaken and trembles and burns up. Caller reported that the patient was so severely nauseous but never throws up. She reported that they are just at their wits end and do not know where to turn. Caller inquired if anyone else was calling with these side effects and if there was anything they can do. She reported that the patient went from being just fine, on no medications, to this. Caller reported that everyone keeps saying they do not know what was wrong with the patient. Caller reported that the patient's physician keeps saying that maybe it is anxiety, but the patient has been on the anxiety medications for 6 weeks and there are no signs of improvement. She reported that she does not want the patient to take the anxiety medications if they are not helping. The patient has been taking the generics for Lexapro and Xanax, escitalopram and alprazolam, for 6 weeks and has shown no improvement. Product strength and count size dispensed: Escitalopram 5 mg; dispensed in pharmacy bottle Alprazolam 0.25 mg; dispensed in pharmacy bottle Additional lot numbers: Caller unable to provide product lot numbers as they were dispensed in a pharmacy bottle. Caller reported that the Escitalopram was manufactured by Accord and the Alprazolam was manufactured by Sandoz. She reported that the patient was started on 5 mg of Lexapro, but the dose has been increased to 10 mg. Caller reported that the patient was taking two 5 mg tablets. Severe nausea: Caller reported that the patient's nausea has worsened. Caller reported that the patient initially would experience nausea for a couple of hours then it would ease. Caller reported that the last 10 days, the patient's nausea is almost all the time. Caller reported that the patient gets a couple good hours maybe before going to bed and that is it. Caller reported that the patient wakes up with severe nausea around 3:30 in the morning like clockwork. Shaking from head to toe: Caller reported that the patients shaking comes and goes. Caller reported that the patients shaking was definitely worse in the morning when she was the weakest or if she was getting a bad bout of it, like the nausea comes on stronger. Burning up inside: Caller reported that the patient feels like she is freezing outside when she was burning up inside. Heaviness in chest: Caller reported that the patient experiences heaviness in her chest when she gets episodes where the nausea and burning up inside, freezing outside come on. Caller reported that the patient does not always have the heaviness in her chest. Weakness: Caller reported that they took the patient to the emergency room a second time because she could barely walk with her walker. Jaw pain: Caller reported that the patients jaw pain comes and goes. Has zero appetite: Caller reported that they have to force the patient to eat. The patient underwent lab tests and procedures which included abdominal x-ray: normal on Apr2021, blood pressure measurement: fine on Apr2021, blood test: normal on 30Apr2021, cardiac function test: normal on 30Apr2021 results were fine computerised tomogram abdomen: all fine on Apr2021, endometriosis: all fine on Apr2021, endoscopy: normal on May2021 and scan brain: normal on May2021. Patient was visited to emergency room and physician's office for the events Jaw pain, heaviness in chest, nausea and weakness. Patient was hospitalized for the events experiencing a heaviness in her chest and jaw pain from 30Apr2021 to 02May2021. Therapeutic measures were taken as a result of the events with Escitalopram and Alprazolam. The outcome of the event's severe nausea, shaking from head to toe, felt like burning up inside, jaw pain, Weakness, has zero appetite, anxiety was not recovered and experiencing a heaviness in her chest, she could barely walk with her walker, like she is freezing outside and she could barely walk with her walker was unknown. Information on Lot/Batch number has been requested.
86 2021-07-10 tingling Began with tingling of feet then swelling of feet, then swelling of both legs. Medical tests. .. ech... Read more
Began with tingling of feet then swelling of feet, then swelling of both legs. Medical tests. .. echo cardio gram, vascular ultrasound, MRI of pelvis, neurological exam of nerves, rheumatologist and immune system. Multiple blood samples all of which were negative with exception of one that showed inflammation somewhere. After all the above test there is no conclusion or diagnosis to the continued swelling . Have never had adverse event following any previous vaccines
86 2021-07-27 feeling cold She also reports developing a rash in the middle of her chest /she describes it as, "looks light pin... Read more
She also reports developing a rash in the middle of her chest /she describes it as, "looks light pink, little teeny tiny bumps, middle of the chest near the neck."; left ankle was itching me like crazy; felt cold/ cold feeling; tired; looks light pink, little teeny tiny bumps; Two weeks after her 1st dose she felt chills and swelling in her lymph nodes.; This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer- sponsored program. An 86-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration on 15Apr2021 11:30 (at the age of 86-year-old) at dose 1, single for covid-19 immunisation. Medical history included Parkinson's disease, autoimmune disorders (she states that she has 4 autoimmune disorders), allergic to an antibiotic, headache. Prior Vaccinations (within 4 weeks) was no. History of all previous immunization with the Pfizer vaccine considered as suspect: no. Additional Vaccines Administered on Same Date of the Pfizer Suspect: no. Concomitant medications were not reported. Patient previously received Pneumovax23 vaccine last year for which patient had experienced Lichen Sclerosus, spinal stenosis, trigger finger on the right hand, spinal stenosis, difficulty walking and dry mouth and pneumonia vaccine, flu shot for which patient had experienced sore arm. On an unspecified date, the patient experienced developing a rash in the middle of her chest /she describes it as, looks light pink, little, teeny tiny bumps, middle of the chest near the neck, left ankle was itching me like crazy, felt cold/ cold, tired, looks light pink, little, teeny tiny bumps, two weeks after her 1st dose she felt chills and swelling in her lymph nodes. Reporter is an 86-year-old female consumer who has received the first dose of the Pfizer COVID-19 vaccine. She is calling today to inquire about whether she should receive the second dose. She states that she has 4 autoimmune disorders, and she thinks she may also have Parkinson's disease. She is concerned that the vaccine might worsen autoimmune disorders. She states that she has Lichen Sclerosus, spinal stenosis, trigger finger on the right hand which started after she received the Pneumovax23 vaccine last year, spinal stenosis, difficulty walking and dry mouth. She does not take any prescription medications. She reports being allergic to an antibiotic that starts with an e and it caused her to have a severe long lasting headache but she cannot recall the name of the medication. She also reports whatever medication they gave her for a stress test caused her heart to race and made her feel like she was going to have a seizure. She states, my arm was not even sore after getting the vaccine, is that normal? My arm was sore after the pneumonia vaccine and the flu shot but not after my covid vaccine, is that normal? The caller then went on to report that "the day after the Pfizer COVID-19 vaccine my left ankle was itching me like crazy. It was a strange kind of itching. It was bothering me, I don't know and then it went away. She also reports developing a rash in the middle of her chest about 2.5 weeks after the first dose of the Pfizer COVID-19 vaccine. She noticed it this past Sunday 02May2021 and she describes it as, looks light pink, little teeny tiny bumps, middle of the chest near the neck. Reporter wants to know if the itching and rash that she experienced with the Pfizer COVID-19 vaccine have been reported before. The reporter stated that she is concerned about taking the second dose of the Pfizer COVID-19 vaccine because she is worried that it could make her autoimmune disorders worse or that she could develop new autoimmune disorders because of the vaccine. Reporter asks how long she can postpone or reschedule her second dose of the Pfizer COVID-19 vaccine until she speaks with her doctor. Reporter stated that she heard 6 million people have not returned to receive their second doses of the Pfizer COVID-19 vaccine and wants to know if we have information as to why they chose not to proceed with the second dose. Reporter stated that she is thinking about not getting the second dose of the Pfizer COVID-19 vaccine as scheduled this Thursday and waiting until September, October or November and just get the booster shot like they are talking about. She wants to know what this agent thinks about that plan. Reporter stated that she has heard getting the second dose of the Pfizer COVID-19 vaccine can cause swollen lymph nodes and that concerns her. Responded per page 2 of the attached document, Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, is likely to have resulted from a robust vaccine-elicited immune response. She is transferring her to report adverse events she experienced after the dose of the COVID vaccine. Two weeks after her 1st dose she felt chills and swelling in her lymph nodes. she has questions about the efficacy of the second dose. The caller clarified the details provided by the transferring agent. She did not have chills. She was just saying she was on her computer in the other room the other day, and all the sudden she felt cold. She always has her house on the same temperature of 76. It is on air-condition because she will be away. The last lady said chills it wasn't chills. She just felt cold. Her nose is stuffed up but was way before the shot. It will be 3 weeks ago tomorrow that she got the vaccine. The cold feeling happened two weeks after the first. The second shot is due tomorrow. She is wondering if she should get it. She noticed she started to feel cold 2 weeks after her first Pfizer vaccine. Is that normal to feel cold. She didn't think about it being the Pfizer vaccine when she got cold. She used to be 5'4.5 but is now 5'0. She got the vaccine at the see formal field Her doctor told her to go to the hospital to get it not a drug store. She waited 30 minutes. She doesn't know if the cold has improved persisted or worsened. She knows she didn't have to put on another layer yesterday. She did still feel a little colder than normal yesterday. She got the vaccine at 1130 am. She didn't even feel it. She didn't have pain in her arm at all. It was like she got no shot at all. She is a little tired now. She needed to take a nap in the last couple of days. This started a couple of days ago. It has almost been 3 weeks wince her first one. see formal field She is wondering if it is normal to have 2.5-week later side effect. She did have a rash on her chest 3-4 days ago, but that was reported. Her doctor is a rheumatologist who deals a lot with the immune system. She did have a stuffed nose before the vaccine for several months now. Adverse event did not lead to visit to Emergency Room, Physician Office. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
87 2021-01-11 discomfort Patient being monitored after vaccine developed swollen uvula and heavy lip 20 minutes after adminis... Read more
Patient being monitored after vaccine developed swollen uvula and heavy lip 20 minutes after administration. Patient given benadryl with relief and evaluated by nurse practioner.
87 2021-01-14 feeling hot Patient received the first dose of the 2-dose Pfizer Covid-19 series and immediately complained of f... Read more
Patient received the first dose of the 2-dose Pfizer Covid-19 series and immediately complained of feeling hot. She was taken to a private area and observed by a nurse. Blood pressure initially was 124/77, but the third blood pressure 20 minutes later had dropped to 95/62. Patient and her husband (in attendance) were advised to go to the ED in the same hospital which they agreed to do.
87 2021-01-20 weakness, tremor Joint and muscle pain, feeling unwell, nausea, weakness, dizziness, shaky, fast heartbeat, tiredness... Read more
Joint and muscle pain, feeling unwell, nausea, weakness, dizziness, shaky, fast heartbeat, tiredness, headache. chills, injection site pain and swelling
87 2021-01-20 feeling cold, difficulty speaking about 1 hour after shot, I got very cold and chilled, then that night or following day, I felt like ... Read more
about 1 hour after shot, I got very cold and chilled, then that night or following day, I felt like I had a cold and sore throat and congested. Each day it got a tiny bit worse, I was soo sick but lethargic and unwell. It got a tiny bit worse the next day but I am hoarse and my throat feels annoyed and I don't feel like me. Even though all this happened I would go through with it again. The injection site hurt the next day and it went away.
87 2021-01-20 flushing, feeling hot Approximately 45 minutes after receiving covid 19 vaccination (Pfizer). Patient reported flushing, f... Read more
Approximately 45 minutes after receiving covid 19 vaccination (Pfizer). Patient reported flushing, feeling hot. Patient was observed 30 minutes after vaccine because they have a history of anaphylactic reaction to shrimp. Patient was discharged in stable condition after observation.
87 2021-01-21 weakness 1840 NSG staff notified that resident had fallen and was unable to get up. Upon arrival to resident,... Read more
1840 NSG staff notified that resident had fallen and was unable to get up. Upon arrival to resident, resident was lying on her right side outside of her room. Resident was severely diaphoretic and unable to state what had occurred. Resident had a blue tinge to her lips, wheezing bilaterally, equal strength bilaterally and very weak. BP 143/74, HR 66, 02 80%, temperature unable to read temporally due to diaphoresis. respirations equal and labored at 22 breaths per minute. EMS called. RN and CNA staff stayed with resident while waiting for arrival of EMS. During this time, son called resident's phone and he was updated of the situation. Upon EMS arrival at 1700, resident was regaining orientation and was no longer diaphoretic. EMS bs was 143. 02 placed on resident by EMS with 12 lead to be done on transport. EMS left with resident at approximately 1907. SJH ED called and given report to RN. DON notified.
87 2021-01-24 involuntary muscle movements, tremor The patient received her 1st Pfizer Covid 19 vaccine then within approximately 10 minutes she starte... Read more
The patient received her 1st Pfizer Covid 19 vaccine then within approximately 10 minutes she started complaining of shortness of breath and stated she "needed oxygen for my heart failure". I then directed her son to wheel her back to a room and the charge nurse grabbed the Oxygen for us. We took a pulse on room air and she was bouncing around 84-85%. At this point she began to have uncontrolled jerking movements in her neck, upper and lower extremities. She was talking during these and never lost consciousness. When the shaking started I had the nurse call 911 to get EMS on the way. She then had her O2 by nasal canula placed and it was turned up to 6L to start until O2 came up to 98%. We then slowly turned town to 3L and maintained SpO2 around 97%. Involuntary muscle jerking continued although it was a little less severe. EMS came and transferred her to the ER.
87 2021-01-24 pain in extremity The caller has a hard time seeing so I am not 100% sure that she read the lot number correctly to me... Read more
The caller has a hard time seeing so I am not 100% sure that she read the lot number correctly to me. My arm hurt me really bad and my armpit hurt really bad. This started a couple of hours after receiving the injection. This lasted about 2 days. I noticed the red spots (bright red and flat) about noon on Friday. They are still there and have not changed since then.
87 2021-01-26 weakness Pt. admitted to the hospital on 22 Jan 21 with Acute on chronic combined systolic and diastolic cong... Read more
Pt. admitted to the hospital on 22 Jan 21 with Acute on chronic combined systolic and diastolic congestive heart failure; CHF (congestive heart failure); Chest pain, unspecified type; Coronary artery disease involving native coronary artery of native heart without angina pectoris; Debility; Ischemic cardiomyopathy; Shortness of breath; Systolic and diastolic CHF, acute on chronic Still admitted as of today
87 2021-01-27 pain in extremity Sore arm; swelling in arm; fatigue; This is a spontaneous report from a contactable consumer (patien... Read more
Sore arm; swelling in arm; fatigue; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0142), via an unspecified route of administration on 13Jan2021 12:30 PM at single dose on the right arm for COVID-19 immunization. Patient is not pregnant. Medical history included bad back and bad left knee. Concomitant medication included unspecified drug (reported as "Other medications in two weeks: Yes"). The patient previously took Levaquin and experienced allergies. Facility type vaccine was hospital. No other vaccines in four weeks. No COVID prior vaccination. The patient experienced sore arm, swelling in arm and fatigue for 24 hours after the shot on 13Jan2021 12:30 PM. Slowly dissipated over next 24 hours. All adverse events went away after 48 hours. No treatment for the events. Patient was not tested for COVID post vaccination. Outcome of the events was recovered on 15Jan2021 12:30.
87 2021-01-27 unresponsive to stimuli Patient has been under Hospice services for almost a year. She began to demonstrate a large amount ... Read more
Patient has been under Hospice services for almost a year. She began to demonstrate a large amount of oral secretions on 1/10/21 at 2130. She was suctioned and a Rapid COVID-19 test was performed, which was negative. The COVID-19 Rapid test was repeated on 1/11/21 and was positive. Oxygen saturation was noted to be 78% on 1/12/21, and oxygen was initiated at 1133 at 3L per nasal cannula. Oxygen was increased to 4L at 1635 d/t shortness of breath. On 1/15/21 @ 0645 patient was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated.
87 2021-01-28 unresponsive to stimuli Patient was an 87 y/o female admitted for septic shock. She was started on and eventually maxed on 3... Read more
Patient was an 87 y/o female admitted for septic shock. She was started on and eventually maxed on 3 pressors. CT abd showed colonic obstruction with dilatation of large and small bowel. Patient was made DNR in the ED. Palliative care consulted on case. Family opted for comfort care. Patient was asystole on monitor. No spontaneous breath/cardiac sounds ausculted. Patient did not withdraw to pain. Pupils fixed and dilated. She was pronounced and 1230 on 1/28/21
87 2021-01-31 inability to speak Aphasia CVA Rhythm IRRegulaR (CardovasculaR) ElEvated Troponin
87 2021-02-01 weakness Patient developed dizziness and weakness. She did not totally pass out because she made it to her ch... Read more
Patient developed dizziness and weakness. She did not totally pass out because she made it to her chair and did not fall on the ground. She described her vision going black. She said that she did not eat today at her normal times which could have contributed to the event. She is asking if the vaccine could have had anything to do with this? She has not had a previous episode like this before. She did have some minor injection site pain at the time of the vaccine but that has subsided. Follow-up call with patient on 1/30/31 at 19:37: Spoke to the patient. She is feeling better today. She did not see her doctor or go to the ED. She checked her glucose yesterday and it was high. She said she thinks her symptoms were from not eating her normal meals around the time of the vaccine.
87 2021-02-01 hot flush About 3 days after vaccine patient reports noticing that her neck was severely stiff and painful. Pa... Read more
About 3 days after vaccine patient reports noticing that her neck was severely stiff and painful. Patient says she could not turn neck at all. This went on for 3-4 days and then she states it started to ease up and she now has more motion but it is still painful at times. Patient also reports she sometime gets chills and hot flashes, but patient has checked temperature and no fever to report.
87 2021-02-01 pain in extremity, burning sensation woke with her right arm feeling like it was on fire and prickly; woke with her right arm feeling lik... Read more
woke with her right arm feeling like it was on fire and prickly; woke with her right arm feeling like it was on fire and prickly/it hurt really bad/hands hurt; This is a spontaneous report from a contactable consumer (patient) reported for herself. This 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch#/Lot#: EK9231) on right arm at single dose on 13Jan2021 for COVID-19 immunisation. Her right arm had a history of going to sleep. Her arm had been going to sleep for less than a year. She thought she may have a pinched nerve. There was no concomitant medication or investigation assessment. Patient got first covid shot a week ago and she didn't know if this was a side effect or not. She got this shot in her right arm. Last night she woke up an 3am and her right arm had gone to sleep but felt like it was on fire and prickly and hurt really bad on 19Jan2021 at 03:00. She got up and shook it and couldn't get it to go away. She was sitting up over an hour and it did lessen somewhat but then started back up. She was scheduled to get her second shot and decided she would get it in her other arm. Patient stated her hands hurt and she was unsure of how long she could stay on the phone. Reporter seriousness for woke with her right arm hurting really bad was unspecified. The outcome of event was unknown.
87 2021-02-03 pain in extremity she was hurting at her chest/ Chest pain; on her left arm hurt real bad that's what the clot on her ... Read more
she was hurting at her chest/ Chest pain; on her left arm hurt real bad that's what the clot on her left arm; on her left arm hurt real bad that's what the clot on her left arm; She passed away; heart attack; This is a spontaneous report from a contactable consumer. An 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus, for which she was taking a pill like an hour before she would take her meal. On Monday (Jan2021) the patient experienced was hurting at her chest/ chest pain, her left arm hurt real bad as she had a blockage in her left arm/clot on her left arm, and they wanted to put in a stent and after the surgery it went well and she all go home in two days. The patient was hospitalized in Jan2021 due to the events. She had a heart attack and that the chamber between the dividers had a hole in it and her heart tissue was too thin so much thin she couldn't repair it. The patient passed away on 26Jan2021. The patient was tested negative for COVID-19 on unknown date. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: She passed away
87 2021-02-04 weakness, pain in extremity, feeling hot like she was going to pass out; Weakness; pains in the stomach/stomach was acting up; can't get to f... Read more
like she was going to pass out; Weakness; pains in the stomach/stomach was acting up; can't get to feeling herself; getting dizzy/ lightheadedness / felt dizzy/ dizziness; She didn't feel good/sick; She wakes up in the night crying; feel like she was little warm; she felt like she was going to die; pain in her stomach was like she had an ulcer; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot number: EL3248), via an unspecified route of administration on 18Jan2021 at single dose in left arm for COVID-19 immunization. Medical history included leg problem, it's severe pain in the right leg in the back; very bad nerves. Concomitant medication included oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for pain in her right leg. The patient had severe pain in her right leg and she was going to pain clinic for that, he was giving 'Propacet' for that. Caller stated that she had the injection on Monday (18Jan2021) at fair grounds, its the Covid Vaccine. She didn't feel good the day she got it on Monday. Then Tuesday she felt good. Wednesday (20Jan2021) she was sick again, and having pains in the stomach, well she can't say stomach, but also towards the afternoon around 2'o clock, she got light headed and dizzy, she felt like she was about to pass out (21Jan2021), and she thought to herself she had to hurry and get something to eat and that feeling last 4-5 hours. She took a pain pill when she got something to eat, and thought to sit down watch a program to take her mind off of it because she felt like she was going to die (Jan2021). After the pain pill and the food it seemed to get better. She wakes up in the night crying (Jan2021), because she was scared if she didn't get better the shot would kill her. Maybe it's her nerves getting the best of her. Her son had the vaccine and had no side effects. She wanted to know if she is the only one having the side effects. While on the phone with this call handler, caller states that she was starting to get dizzy again but she just had breakfast. Her First Dose was on 18Jan2021 Mon, and on the way home she said to her son she was getting dizzy/ lightheadedness. Her son said to her its not from the shot, but she was getting dizzy. On 19Jan2021 Tuesday, she felt good that day. On 20Jan2021 Wednesday, she was Sick again, with weakness, dizziness, she can't get to feeling herself and she had Pain in the stomach. On 21Jan2021 Thursday she felt dizzy, like she was going to pass out. On 22Jan2021 Friday she was feeling dizzy again, and her stomach was acting up and she was weak again. Caller was dizzy and weak. The dizziness was a different each time, sometimes she has got it, sometimes she didn't, its intermittent, she would be doing something and then she needed to grab a hold of something when the dizziness come on. Her Weakness was about the same. She was not feeling the stomach pain right at this minute, when she woke up during the night with it and last felt it 5 or 6AM this morning, she had chores and tasks to do this morning, but her heads going at that time also around 5 or 6 o clock, it was about the same as Wednesday, she just felt like she needed to get something to settle her stomach down, like she needed something for the energy. When attempting to get the product details, caller states that she was getting old, she provided EL3248, she needed light to read it. The card did have an Expiry date but she can't read it, it's 20 something, she just can't read. She was on nothing new. She took a pain pill when she got home but it didn't help, she was still dizzy. The pain pill was Percocet, it was dispensed in a brown pharmacy vial. Medical Conditions: She has a leg problem, it's severe pain in the right leg in the back, she wears a back brace, she needed an MRI Monday. Caller stated the date 12Feb2021, but did not confirm what this date was for. She didn't know how she would get the MRI if she didn't feel better. They were trying to pinpoint the pain in the leg. They tell her that she was in good health for 87 years of age, when they put her in back brace she felt good. On Monday when she got up there she was a little weak and they put her in a wheelchair that day, this past Monday. She had No results to share but she had a X ray a couple weeks ago (Jan2021), and that would lead up to MRI she was going to have. Caller stated that she had very bad nerves, her husband passed away 2 years ago and she hasn't overcome that, she lived by her-self, and was wondering if some of this stress, would lead to the symptoms she was having right now. She wanted to know if these are normal side effects and if it safe to have the second dose. Caller stated that she was slow and old. Consumer further stated, she didn't know if she got the right party or not. She just want to know if she was having a reaction to the COVID-19 injection (COVID-19 Vaccine) that she had on Monday, she didn't have a (distorted voice) that serious, like the whole Monday she was sick, Tuesday she felt fine, yesterday she was so stressed she can't hold her head up today she felt good but about 2 o'clock, she had pain in her stomach and she had it all the time, the pain in her stomach was like she had an ulcer and all of sudden she feel like she was little warm (Jan2021) and had to pass out and then get something to eat and sit down and take something for pain and it last about two hours and then go away and about 4 hours later she got it right back. She just wanted to know if that has anything to do with (incomplete sentence). She was not sure if she should (incomplete sentence), she was scared to have a second injection. Second due date of vaccine was 08Feb2021. The outcome of the events getting dizzy/ lightheadedness / felt dizzy/ dizziness, Weakness, pains in the stomach/stomach was acting up was not recovered, of the other events was unknown.
87 2021-02-07 flushing, discomfort Patient had complaint of feeling faint/uneasy. initial heartrate estimated 90, warm flushed cheeks. ... Read more
Patient had complaint of feeling faint/uneasy. initial heartrate estimated 90, warm flushed cheeks. After resting, heart rate remained at 80. After 30 minutes patient still felt uncomfortable, heart rate 80 but felt okay to drive home.
87 2021-02-07 pain in extremity headache lasting 18 days after vaccination, affecting eyes, chills, calves sore on both legs
87 2021-02-08 weakness She developed chills, headaches and weakness starting the day after vaccination 1/14. Profound weakn... Read more
She developed chills, headaches and weakness starting the day after vaccination 1/14. Profound weakness. She was unable to get out of bed. She developed hypoxia 86 to 90%. She was sent to the emergency room, she was noted to have a urinary tract infection.
87 2021-02-08 flushing Roughly 7 hours after receiving vaccine patient complained of difficulty breathing. Per patient's wi... Read more
Roughly 7 hours after receiving vaccine patient complained of difficulty breathing. Per patient's wife/caregiver, patient appeared anxious, skin color appeared abnormal, and pulse was weak and bradycardic (not unusual for patient). Albuterol nebulizer treatment attempted but patient was too anxious to complete. Gave 2 puffs albuterol oral inhaler, and repeated treatment 15 min later followed by a small glass of cola. About 30min later patient calmed, no longer short of breath and pulse strong but face remained flushed. Vitals at 9:20pm included BP 116/47, pulse 67. Following day patient had multiple involuntary diarrheal stools. Symptoms reported to provider 2/8 and noted to be resolved.
87 2021-02-08 tingling Pt presents for s/e after 2nd dose COVID 19 pfizer vaccine today, about 1-2 hours prior to office vi... Read more
Pt presents for s/e after 2nd dose COVID 19 pfizer vaccine today, about 1-2 hours prior to office visit. She called over to the medical staff because her right side of mouth became tingly, and her right eye hurt about 5 minutes after vaccine. The episode lasted about 10-15 minutes per Patient, and did not loose consciousness She brings in a rhythm strip with only BP- she denies having EKG. BR 218/94 and HR 63 @1224, and 195/99 HR 64 @ 1228. They called EMS, and pt declined to go. She denies any CP, SOB, no slurred speech or sudden weakness during the episode. Denies swelling of face or lips, no dysphagia. No meds administered at clinic. Pt has not taken any additional medications today.
87 2021-02-09 flushing 1/26 vaccination, high heart rate, and flushed, two days after shot sever pain around shoulder blade... Read more
1/26 vaccination, high heart rate, and flushed, two days after shot sever pain around shoulder blade, went to PCP doc said he thought it was inflammation around rib ca
87 2021-02-09 migraine with aura migraine aura/migraine that was strong enough that she could not see; flashing lights; blocked visio... Read more
migraine aura/migraine that was strong enough that she could not see; flashing lights; blocked vision/migraine was strong enough that she could not see; This is a spontaneous report from a contactable consumer reported for herself. A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on left arm on 18Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication reported as unspecified (Caller states that she does take a few medications but nothing has changed with those in years, so she does not think anything else is relevant). Historical vaccine include flu shot and does have reactions. Caller stated she received Pfizer COVID shot first dose and within an hour she had migraine without the headache but did have the vision blocked out. It resolved after some time. she wanted to know the ingredient of the vaccine to see if she should take the second dose. Caller states that she had her first Pfizer COVID Shot on 18Jan2021. Caller states that she didn't have any of the ordinary reactions, both the caller and her husband had the shot and neither of them got a sore arm or swelling at the site. Caller states that after they stayed for a half an hour, and when they were driving back to, the caller started to get a migraine aura. Caller states that she has had them before, but not often, and she has not had one for about 10 years. So caller states that her aura started while they were driving, and then the caller's husband dropped the caller off at the grocery store. After being dropped off, caller states that her migraine came on strong. Caller states that her migraine was strong enough that she could not see, she was experiencing flashing lights, and blocked vision. Caller finally turned to another customer to ask if he could see the cucumbers in front of them. Caller states that she waited outside for her husband to get her. Caller states that migraine probably lasted for about 45 minutes. Caller is wondering if this could have been from the shot or not. Caller states that she does have reactions to flu shots sometimes, but not like this. Outcome of the events was recovered on 18Jan2021.
87 2021-02-12 weakness, involuntary muscle movements Mom became so weak that she couldn't stand or walk without falling down. She seemed unable to contro... Read more
Mom became so weak that she couldn't stand or walk without falling down. She seemed unable to control her legs and feet and was unable to sit up unassisted. She was admitted to the hospital on February 11, about 36 hours after receiving the vaccine. She had elevated levels of troponin, but all other cardiac tests came back normal. She had no other abnormal test results. Today, February 13, is the first day she has been able to walk a few steps and sit up without assistance.
87 2021-02-18 pain in extremity, tremor Tiredness afternoon throughout following day, lower back pain began during late afternoon on right ... Read more
Tiredness afternoon throughout following day, lower back pain began during late afternoon on right side, by next morning, across full lower back. Afternoon of day after (2/18/22) severe pain in left leg at hip joint at groin area. This pain was so severe had to have assistance walking, sitting and standing up, undressing. The day after vaccine also had chills causing shaking of hands in the mid-afternoon, relieved by adding blankets. Woke on Friday the 19th feeling normal
87 2021-02-20 weakness ON 01/26/21 THE DAY FOLLOWING MY FIRST DOSE OF COVID-19 I BEGAN FEELING SOME LIGHTHEADNESS & WEAKNES... Read more
ON 01/26/21 THE DAY FOLLOWING MY FIRST DOSE OF COVID-19 I BEGAN FEELING SOME LIGHTHEADNESS & WEAKNESS. I ALSO EXPERIENCED SEVERE STOMACH CRAMPS & SEVERE DIARRHEA. THE SECOND DAY (01/27/21) AFTER MY VACCINE, I BEGAN FEELING WEAKER, LIGHTHEADED, AND THEN LATER THAT EVENING I EXPERIENCED A PEIRCING HEADACHE WITH INTENSE PAIN ON FRONT LEFT SIDE OF MY HEAD. THE LIGHTHEADNESS CONTINUED FOR 3-4 DAYS. IT WAS WITHIN THAT FIRST WEEK I REALIZED MY PULSE OX WAS READING 88-90 bpm . PRIOR TO THIS MY PULSE RATE ROUTINELY WAS BETWEEN 60-64 bpm. I SAW CARDIOLOGIST ON 2/5/21, AFTER ECG AND EXAM DOCTOR STATED MY HEART RATE WAS IRREGULAR, POSSIBLY A FLUTTER, AND ORDERED A HEART MONITOR TO WEAR AT HOME FOR 2 WEEKS.
87 2021-02-21 numbness Pfizer-BioNTech COVID-19 Vaccine EUA: soon after receiving vaccination patient reported headache and... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: soon after receiving vaccination patient reported headache and numbness in both feet and right hand. Twenty minutes after vaccination reported nasal congestion, worsening headache, and not feeling well. Initial vitals within normal ranges except blood pressure 159/85 mm Hg, repeated 15 minutes later at 144/80 mmHg. Medical evaluation team arrived and allergy provider contacted: patient administered oral diphenhydramine. Patient discharged to home from vaccination clinic improved and stable. On scheduled follow-up encounter with primary care provider three days later patient did not report any symptoms from vaccination.
87 2021-02-24 weakness Patient received vaccine in public vaccine clinic, was recovered for 15 minutes and drove self home.... Read more
Patient received vaccine in public vaccine clinic, was recovered for 15 minutes and drove self home. Upon walking into her apartment, began feeling extremely tired, dizzy and weak, then developed GI symptoms. Was seen by her pcp on 02/19. It was noted that she was newly bradycardic, 40 bpm.
87 2021-02-25 pain in extremity Forty minutes after second shot, I got a bad pain in the back of my upper right thigh. I had to lim... Read more
Forty minutes after second shot, I got a bad pain in the back of my upper right thigh. I had to limp to my apartment. I didn't think it could be related to the vaccine as it was so soon, and only in the one place. It had lasted until now and I've had three physical therapy visits so far, though it is not as bad, but it's over three weeks. I didn't think it could be related until my doctor's office said they had four cases of the exact same thing, and in younger people. (20's and 30's). At first, the PT said it was due to a pulled muscle, though I had done nothing at all to account for that.
87 2021-02-27 weakness Severe Dizziness, dry heaves, chills, weakness, lasting 2 1/2 days, 4 days after shot #2
87 2021-02-28 facial paralysis, bell's palsy Pt had Covid vaccine on February 8th. Her daughter saw her on February 15th and noted right sided fa... Read more
Pt had Covid vaccine on February 8th. Her daughter saw her on February 15th and noted right sided facial drooping. Pt noited her right eye had been tearing quite about for at least 2 days prior to the 15th.
87 2021-03-01 numbness Dizziness, numbness of both hands. Placed in supine position for 40 minutes. Apple juice given. BS 9... Read more
Dizziness, numbness of both hands. Placed in supine position for 40 minutes. Apple juice given. BS 92 to 137. BP 142/67 (pulse 69), O2 sat 100%. Repeat BP 150/79 (pulse 69), O2 sat 100%.
87 2021-03-03 weakness Severe gas bloating; stomach cramps; Nausea; Feeling very weak; This is a spontaneous report from a ... Read more
Severe gas bloating; stomach cramps; Nausea; Feeling very weak; This is a spontaneous report from a non-contactable consumer reported for herself. An 87-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19), via an unspecified route of administration on 05Feb2021 10:30AM on right arm at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced severe gas bloating, stomach cramps, nausea, feeling very weak on 07Feb2021 with outcome of not recovered. She is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was unknown. The case was assessed non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
87 2021-03-03 numbness After receiving her vaccine, client stated that she has numbness in both hands. Vital signs obtaine... Read more
After receiving her vaccine, client stated that she has numbness in both hands. Vital signs obtained by EMS B/P 158/68, HR 60, o@ sat 97%. Client stated she is feeling better. Client discharged home by EMS.
87 2021-03-03 seizure, cold sweat, flushing After receiving the vaccine client became flushed, clammy, labored breathing, LOC, and had seizure l... Read more
After receiving the vaccine client became flushed, clammy, labored breathing, LOC, and had seizure like activity. After she came to, she c/o not feeling good and lightheaded. She was taken by ambulance to the hospital. Husband said they ran several tests. She continues to sleep a lot and is sore all over.
87 2021-03-07 weakness Headache, Weakness, Fell from bed
87 2021-03-08 inability to speak She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after wa... Read more
She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.
87 2021-03-12 pain in extremity Pfizer-BioNTech COVID-19 Vaccine EUA: two days after vaccination patient reports in clinic visit pai... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: two days after vaccination patient reports in clinic visit pain on right side of hand and leg, diarrhea, chills, difficulty urinating, and fever one day after vaccination. By the time of clinic visit symptoms resolved except for diarrhea. No rash or respiratory symptoms reported. Patient able to manage symptoms at home.
87 2021-03-14 flushing Presyncopal episode with nausea, flushing, lightheadedness, need to defecate
87 2021-03-15 weakness Tinnitus, weakness, headache, loss of thought process, can?t walk. Lasts about 80 minutes. 3 episo... Read more
Tinnitus, weakness, headache, loss of thought process, can?t walk. Lasts about 80 minutes. 3 episodes so far. First time called Para medics, second time 4 days later went to Emergency room, CT scans, blood work, given fluid IV. 12 hours later same symptoms went back to ER told just lay down. First event 3/11
87 2021-03-19 flushing 2/22/2021 9 PM (angioedema) swollen/red lips, flushing chest, red earlobes, red behind ears, difficu... Read more
2/22/2021 9 PM (angioedema) swollen/red lips, flushing chest, red earlobes, red behind ears, difficulty swallowing when eating, throat congestion throughout the day for 4 weeks 2/24/2021 benadryl 25 mg up to 4 times/day; prednisone 10 mg increased to 30 mg 2/26/2021; famotidine 20 mg once/day; zyrtec 5mg discontinued after 2 days due to reactions - replaced with claritan 10 mg daily 3/1/2021 emergency room admission for observation continuing above medications
87 2021-03-21 pain in extremity mass on right lung fall, arm fracture arm pain leg pain death
87 2021-03-22 inability to speak, numbness After vaccination my right arm went numb, then my leg, face and speech. I was taken by ambulance to ... Read more
After vaccination my right arm went numb, then my leg, face and speech. I was taken by ambulance to hospital where they ran test and gave me magnesium and potassium and kept me overnight, they sent me home with a heart monitor and I still have it.
87 2021-03-23 weakness Fell twice due to weakness, next day didn't feel good, admitted to hospital, after MRI it was determ... Read more
Fell twice due to weakness, next day didn't feel good, admitted to hospital, after MRI it was determined a stroke had occurred
87 2021-03-23 pain in extremity I had pain in both my right and left upper arm and shoulder. I had difficulty walking due to pain in... Read more
I had pain in both my right and left upper arm and shoulder. I had difficulty walking due to pain in my back side., both sides . Difficulty getting out of the truck and walk ing up the front steps to my home. The next morning, pain was noted in knees and the sides of my feet I had stiffness and swelling in my joints and stayed on the sofa most of the day. These symptoms stayed with me for four days. I took tylenol for the pain.
87 2021-03-27 weakness Patient received the injection on May 2nd. Following the injection, we noticed an increased weaknes... Read more
Patient received the injection on May 2nd. Following the injection, we noticed an increased weakness and general achiness. On the 8th she was so weak that we purchased a gait belt to assist her. We were not super concerned as we were expecting the second shot to cause body aches or flu like symptoms based on what we had heard from others who had received both vaccine shots. She continued to be unsteady and we found that she has a mild UTI which we had begun treating with prescribed antibiotics. Late afternoon on the 11th, mother suffered a major stroke. we did not take her to the hospital because we had already been told that they would not be able to do anything at her age should she suffer a stroke. On the 12th I called the doctors office and asked for them to send Hospice to the house as we could tell that she was dying. Mother died on the 13th. Just a week prior to her death I had spoken with Dr. and we had discussed how that she was declining in health but that she was not even close to needing Hospice, yet she is dead a week later. Less than 2 weeks after getting her second Covid Shot.
87 2021-03-28 tingling 2nd COVID vaccine on last Wednesday afternoon 3/24/21. Started to experience pins and needles in he... Read more
2nd COVID vaccine on last Wednesday afternoon 3/24/21. Started to experience pins and needles in her right hand since late Wednesday - the same arm that the injection was in. Now she is noticing some blisters on her right hand, those she noticed today. The following day of the injection the pain was so severe to the right arm from the shoulder all the way down the arm unable to lift the arm or movement. Pain is improving today . Still has the blisters to the hand. Pain in right shoulder and across the back of her neck - all on the right side. Used Tylenol and Lidocream OTC - helped very temporarily. Also had fatigue lasting about a day and a half.
87 2021-03-30 weakness, pain in extremity Thigh pain; Hip pain; Vomiting; Shaky/Real shaky; she collapsed because of weakness in her legs/Legs... Read more
Thigh pain; Hip pain; Vomiting; Shaky/Real shaky; she collapsed because of weakness in her legs/Legs collapsed on her; pain in her legs/Leg pain; weakness/Real weak; fatigue; severe headache; This is a spontaneous report from a contactable consumer received via Medical Information Team. An 87-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:00 (Batch/Lot number was not reported) (at the age of 86-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 for COVID-19 immunisation and experienced urinary tract infection; the patient previously took clindamycin hydrochloride (DYNACIN) and experienced allergy, gabapentin and experienced allergy, doxycycline which made her pass out and lose complete control of muscles and everything and put her in the hospital for 3 days. The patient experienced severe headache on 14Feb2021; the patient collapsed because of weakness in her legs/ legs collapsed on her and experienced pain in her legs/leg pain, weakness/real weak and fatigue, all on 22Feb2021; shaky/real shaky on 24Feb2021, vomiting on 26Feb2021, thigh pain and hip pain on 27Feb2021. Clinical course: on 22Feb2021 she saw her primary care physician for leg pain, weakness, fatigue and the same severe headache that she was seen for on 14Feb2021. On 22Feb2021 she was prescribed cyclobenzaprine and tramadol as pain medication. Before she took any of the cyclobenzaprine or tramadol on the night of 22Feb2021 her legs collapsed on her. On 24Feb2021 they called the doctor and told them that she had collapsed again, and he said to stop the cyclobenzaprine and changed tramadol dose to half strength. She started being shaky. On 26Feb2021 they called the doctor back because she had the same symptoms with the addition of vomiting. They said to stop the tramadol and start taking TYLENOL. On 27Feb2021 they went back to the urgent care for the same symptoms as well as leg pain, thigh pain, hip pain, being really shaky and real weak. The patient underwent lab tests and procedures which included blood test: everything was ok (her bloodwork is fine) on an unspecified date, computerized tomogram (CAT scan): everything checked out just fine on 14Feb2021, Urine test: urinary tract infection on 04Feb2021 and worsened urinary tract infection on 16Feb2021. Therapeutic measures were taken as a result of the events and included treatment with cyclobenzaprine (strength: 5mg) as a muscle relaxer and tramadol (strength: 50 mg) as pain medication both from 22Feb2021, tramadol was stopped on 26Feb2021 and TYLENOL (every 8 hrs. strength: 650 mg, Lot Number: SBA002, Expiry date: Dec2022) was started on the same date. The patient outcome of the event was unknown. Information on the lot/batch number has been requested.
87 2021-03-30 mild one side paralysis, slurring Stroke (blood clot in right brain), resulting in slurred speech and left-side weakness
87 2021-04-02 numbness, restless legs syndrome, burning sensation Restless legs; Reaction with her legs; Burning of my legs/my legs feels like they are hot; I am havi... Read more
Restless legs; Reaction with her legs; Burning of my legs/my legs feels like they are hot; I am having a sort of numbness feeling in my legs/I am experiencing a sort of numbnessin my legs, in my legs in the muscles; hard of hearing; This is a spontaneous report from a contactable consumer. An 87-years-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 2 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) and dose 1 via an unspecified route of administration on 16Jan2021 (Batch/Lot Number: EL8982) both as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced restless, reaction with her legs, burning of legs/ legs feels like they are hot, sort of numbness feeling in legs/ legs in the muscles, hard of hearing. Therapeutic measures were taken because of restless legs which included over the counter drugs. Patient's lab data was not reported. Outcome of the events was not reported. When requested for probing, Reporter stated, "No." Further probing could not be done as reporter don't want to share further information. Hence, limited information was available over the call. Follow-up activities have been completed and no further information is expected.
87 2021-04-04 feeling cold I was fine friday, my arm never hurt...awoke at 3AM and could not sleep so read and fell asleep and ... Read more
I was fine friday, my arm never hurt...awoke at 3AM and could not sleep so read and fell asleep and awoke at 9:00AM...got up and proceeded to do daily chores....and sudenly i did not feel very good, had a head ache, chills, body aches, trouble catching my breath, stomach discomfort, (not an feeling like i was going to be sick to my stomach, but just did not feel like eating anything), was dizzy, and very tired....the worst was the disorintation....was afraid i was going to pass out....laid down and fell asleep...when i awoke an hour later i felt worse....fell back asleep for another couple of hours....drank a lot of water, ate some cheese and crackers late in the day....slept thru the night and woke up on Sunday morning feeling fine....again arm never was sore....I have described all the symptoms i had on Saturday April 3rd.....i do not know what else you want
87 2021-04-12 numbness and pain in extremities Extreme lethargy; Exacerbated symptoms of peripheral neuropathy; Difficulty sleeping; This is a spon... Read more
Extreme lethargy; Exacerbated symptoms of peripheral neuropathy; Difficulty sleeping; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer representative. An 87-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 28Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. On Sunday (28Mar2021), the patient had exacerbated symptoms of peripheral neuropathy throughout the evening with difficulty sleeping. Day 1 post-vaccination (Monday, 29Mar2021), the patient experienced extreme lethargy. The outcome of the events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
87 2021-04-13 weakness Patient received her 1st dose of Pfizer COVID vaccine on 3/29/21. On ~ 4/11/21, the patient develop... Read more
Patient received her 1st dose of Pfizer COVID vaccine on 3/29/21. On ~ 4/11/21, the patient developed weakness, fatigue, and confusion. She was brought to the ER by her daughter on 4/13/21 and was found to be febrile and hypoxic. CXR consistent with COVID pneumonia and COVID test came back positive as well. Patient was then admitted to the hospital for COVID treatment and was started on dexamethasone and remdesivir.
87 2021-04-13 facial paralysis, inability to speak, mild one side paralysis 3hrs after the patient's vaccination, she fell to the floor and was unable to get up, noted to have ... Read more
3hrs after the patient's vaccination, she fell to the floor and was unable to get up, noted to have R sided facial droop, inability to speak, R sided weakness. Found to have a large stroke with left sided M2 MCA clot noted on CT angiogram.
87 2021-04-13 pain in extremity Early on Sunday morning, April 4th, patient woke up with swollen right hand with immense pain. On Mo... Read more
Early on Sunday morning, April 4th, patient woke up with swollen right hand with immense pain. On Monday, April 5th an ultrasound confirmed a blood clot in her right forearm.
87 2021-04-16 pain in extremity I ended up with Covid Toes. The fourth toe on the left foot pulsated with pain for several hours th... Read more
I ended up with Covid Toes. The fourth toe on the left foot pulsated with pain for several hours that night. Two nights later the same thing happened on my right foot. Several of my toes ended up with scabs on the tips of the toes. My dermatologist told me that my toes had hemmouraged on the inside and the scabs were a result of that. She had not seen anything like that. I have looked at all the images of Covid Toes on the internet and have not seen any with scabs on the tips of the toes.
87 2021-04-17 tremor she had a cold chills through the day; she was in bed most of the day almost all those day; upset st... Read more
she had a cold chills through the day; she was in bed most of the day almost all those day; upset stomach; She is not been eating; She is not dehydrated; Dizziness; Headache; she already getting the flu; she ended up with such bad shake; she is allergic to lot of prescription medication; Vomited; This is a spontaneous report received from a contactable consumer. A 87-year-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration at the left arm on 25Mar2021 at single dose for COVID-19 immunization. The patient's medical history included asthma, fibromyalgia, arthritis (patient had arthritis from long time) and high blood pressure. Concomitant medications included lisinopril 20 mg, 1x/day. It was reported that patient started to vomit few hours later and then she had a cold chill through the day. She had like on Thursday with a vaccine and here it is Monday this is Tuesday now really and she was getting better, but she was in bed most of the day almost all those days and she was upset stomach. It was reported that patient was on real like she gonna jump right out of the bed and she finally settle down. On 30Mar2021, patient had a very bad reaction, she had a shake. It was reported that patient was not been eating. She was not dehydrated she is not been drinking lot of water. The patient had took the dramamine for her upset stomach and motion sickness. The takes only when she needs it about twice a day mostly so far. It was reported that at first because of motion sickness in the car but it quite away we had to go and after that it was terrible, it just continued every day after that. She vomited first day very bad and rest of the day upset stomach then when she started taking dramamine. The patient also had like dizziness, headache and shake. The patient acted like she already getting the flu of some sort. It was reported that patient was allergic to prescription medication. She took Dramamine for upset stomach and then took Tylenol (Acetaminophen), 500mg each, every 4 hour 2 tablets for headache." It was reported that patient will not get second vaccine then because she does not want to experience this all over again. Outcome was reported as not recovered for chills, dizziness, headache, influenza and unknown for bedridden, upset stomach, vomiting, ended up with such bad shake, She is not been eating; She is not dehydrated and is allergic to lot of prescription medication No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
87 2021-04-23 pain in extremity no appetite; Chills; Diarrhea; Fatigue; Pain in arm; Cough; Nasal congestion; This is a spontaneous ... Read more
no appetite; Chills; Diarrhea; Fatigue; Pain in arm; Cough; Nasal congestion; This is a spontaneous report from a contactable Nurse (patient herself). A 87-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EL3249; Expiration Date: May2021) intramuscularly administered in right deltoid on 02Feb2021 at 0.3 ml single, for COVID-19 immunization. Medical history included hypertension (she had hypertension, or high blood pressure, which she was treated for). There were no concomitant medications. Caller says she has not had any other recent vaccinations or started any new medications. On 02Feb2021, the patient experienced cough, nasal congestion, fatigue and pain in arm, on an unspecified date, patient experienced chills, diarrhoea and no appetite. Retired RN (registered nurse) called as patient about the Pfizer COVID-19 vaccine, who says she was wondering about the shot that she got the first dose of last Tuesday. She says she has been looking at the sheet of side effects etc, and she had cough, which was not listed, and nasal congestion, no appetite, chills, and diarrhoea started on the second or third day after getting the vaccine. Caller says her cough started when she came home, and she was really exhausted after that, the cough was not bad. She asks if the vaccine is made in Germany. She says that the fatigue and pain in her arm lasted three days. Caller says that she feels it is medically significant, and she is not going back for the second shot. She took Mucinex for the nasal congestion, and for her diet she ate soup. Caller says this medication was over the counter and not prescription. Caller says that she feels it is medically significant, and she is not going back for the second shot. The outcome of the events was unknown.
87 2021-04-27 weakness, pain in extremity feeling like she had no strength in her upper body as if she were about to collapse; muscle weakness... Read more
feeling like she had no strength in her upper body as if she were about to collapse; muscle weakness; have felt a little weak; muscles were being lost in the top of her, it stopped before got to legs; left side of neck sore; arm sore; arm soreness and neck stiffness; This is a spontaneous report from a contactable consumer (Patient). A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Feb2021 as single dose for covid-19 immunisation. Medical history included Left Hip Replacement from 17Dec2019 to an unknown date (she did experience a loss of feeling in her legs, and one time she even had a fall from it, like her legs did not hold her up). The patient's concomitant medications were not reported. The patient previously took enoxaparin sodium started the product on 20Dec2019 and stopped it on 27Dec2019, even though she was supposed to take it for 14 days. Patient got the first shot of vaccine on 06Feb2021 and her only side effects were that her arm was sore which present till 09Feb 2021, and her left side of her neck was sore from 07Feb2021 to 09Feb 2021. On 09Feb2021, she was at her kitchen sink and it was like her muscles were being lost, in the top of her, but it stopped before it got to her legs, and then she felt okay. she had not experienced that again, but on 10Feb2021, she has felt a little week. Caller is wondering if that could have been a side effect of the vaccine. Patient stated that, she was taller but she thinks she is now between 4' 11 and 5 foot. She got the vaccine in her left arm, and it was her left arm that was sore. she had no other vaccines on the same day as the COVID vaccine. Patient stated that after her hip replacement, she did experience a loss of feeling in her legs, and one time she even had a fall from it, like her legs did not hold her up. Patient stated that the fall occurred four days after starting a blood thinning medicine called Enoxaparin and once she stopped that medicine, she got to feeling better. she read somewhere that the COVID shot was given in the muscle, and that was why she thought the COVID shot might be related to her feeling like she was losing her muscles in her top half last night. The outcome of the event arm soreness, neck stiffness, left side of neck sore and muscles were being lost in the top of her, it stopped before got to legs was recovered and for other it was unknown. Information on the lot/batch number has been requested.
87 2021-05-04 pain in extremity 2nd dose: arm hurt a little; This is a spontaneous report from a contactable consumer (patient). An ... Read more
2nd dose: arm hurt a little; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly on 04Feb2021 at 15:10 (at the age of 87-years-old) as a single dose in the arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 (lot number EL8982) on 14Jan2021 at 14:50 as a single dose in the arm for COVID-19 immunization. On an unspecified date after dose 2 of BNT162B2 the patient experienced arm hurt a little. The event was reported as non-serious. The outcome of arm hurt a little was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
87 2021-05-06 weakness Extreme exhaustion, weakness. Ultimately death on 4/29/2021
87 2021-05-07 weakness blockage arteries; give her steroids on 22Feb2021 for a week (prednisone pack) and when they stopped... Read more
blockage arteries; give her steroids on 22Feb2021 for a week (prednisone pack) and when they stopped that she got another shot of steroids; who have had serum sickness; bad cold that won't go away; She very weak; malaise; serum sickness but it didn't turn out to be that / pretty sick now and they are trying to figure out what is going on; fatigue; This is a spontaneous report from a contactable consumer. A 87 Years non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9269), intramuscular, administered in Arm Left on 10Feb2021 as SINGLE DOSE for covid-19 immunization and previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 1 as SINGLE DOSE for covid-19 immunization. The patient's medical history included HTN, Cholesterol, Thyroid, statin sensitivity, borderline hypertension, stents. The patient's concomitant medications included ZETIA(EZETIMIBE), AMLODIPINE, METOPROLOL, THYROID, BIESTROGEN (ESTRADIOL, ESTRIOL). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the second dose of the vaccine on 10Feb2021 and then a day or so after she developed what the physicians called serum sickness but it didn't turn out to be that. They started to give her steroids on 22Feb2021 for a week (prednisone pack) and she asked if the vaccine have less efficacy and when they stopped that she got another shot of steroids on 26Feb2021. It turned out she did not have the classic symptoms but have been quite sick. The pharmacist said you need to find out if the vaccine is still effective with all the steroids. She said she is in good health and is very athletic and she is pretty sick now and they are trying to figure out what is going on. She asked if her second vaccine was still effective with the steroids. Wants to know if steroid treatments will interfere with covid vaccine. Caller stated that she was fine after she received the first Pfizer Covid vaccine, but after receiving the second vaccine on 10Feb, she has felt like she's experiencing the onset of a bad cold that won't go away. She very weak and cannot do things that she normally does. Two weeks after her second vaccination, she was prescribed a methylprednisolone pack for a week and then she got a "big shot more" and then her doctor stopped for fear that had "played with her immune system". She's had her blood drawn and her lab values have all come back in normal range. Her doctor has tried everything he knows to do, but she cannot seem to pull out of it. Her second vaccination for Covid-19 was on 10Feb2021. Previous to that I was in good health, very active such as playing tennis and working out in the gym. she do, however, have borderline hypertension with six stents. Her blood pressure fluctuates 120's to the 140's. After the second shot was given she had a malaise which lasted for almost a month. When It first appeared she really felt as though she had the flu. Much the same symptoms. She had to Frequently rest even though we had to move from out home the next month. Her husband was a big help and she struggled to do her share. The patient health care provider contacted Pfizer to try and get some information as it was difficult to know how to treat this problem. There wasn't any solution so she just rode it out. Last week she finally started back to the gym. She had been walking several miles daily two weeks before that. Unrelated was a hospitalization for several days 31Mar2021 with a suspicion that she had a blockage In her arteries. A Cath procedure said everything had been running smoothly and her heart was beating correctly. So all those suspicious were ruled out. It was noted that she had made antibodies for Covid-19. She can't be more definite than saying she had flu like symptoms for about a month after the second shot. On an unspecified date, The patient experienced blockage arteries, give her steroids on 22Feb2021 for a week (prednisone pack) and when they stopped that she got another shot of steroids, who have had serum sickness, bad cold that won't go away, She very weak, malaise, On 11Feb2021 serum sickness but it didn't turn out to be that/pretty sick now and they are trying to figure out what is going, fatigue. The patient received treatment for adverse event (Medrol dose Pack, Decadron 6 mg IM x1 ). The clinical outcome of the events were unknown and outcome of the events bad cold that won't go away, serum sickness but it didn't turn out to be that pretty sick now and they are trying to figure out what is going, fatigue were Not recovered.
87 2021-05-13 weakness Acute kidney failure, unspecified WEAKNESS - GENERALIZED ALTERED MENTAL STATUS
87 2021-05-13 flushing Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pat... Read more
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient laid on floor was given water sat up rested i chair for 20 minutes and was fine. Has had history similar reaction to shots
87 2021-05-25 weakness ED to Hosp-Admission Discharged 5/19/2021 - 5/24/2021 (5 days) Last attending ? Treatment team Ac... Read more
ED to Hosp-Admission Discharged 5/19/2021 - 5/24/2021 (5 days) Last attending ? Treatment team Acute respiratory failure with hypoxia DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission From admission " Patient is a 88 y.o. female who presents to the hospital today withincreasing weakness, falls over the last few days. She has not been eating or drinking well. It appears she recently started a sulfonylurea. EMS arrived blood sugar 58 and upon arrival to the ER blood sugar was 35 and she was lethargic. Given orange juice and a dextrose bolus with improvement of her blood sugar. Room air sat was 88% on room air however she only feels short of breath but she did not wear oxygen at home. Family member has Covid but she does not endorse any contact with them. In ED she was found to be positive for COVID19, with AKI and SIRS and internal medicine was asked to admit the patient." Hospital Course Patient mandatory medical surgical floor. She was found to have acute hypoxic respiratory failure due to COVID-19 pneumonia. She was found to be 88% on room air and was requiring 3 L of nasal cannula oxygen fourth her first 3 days of admission. She received treatment for her viral infection with IV remdesivir as well as IV dexamethasone to complete 5 days. She also was treated with azithromycin and ceftriaxone. However this was later stopped as her procalcitonin level was not negative. Because her urine showed pyuria she was continued on IV ceftriaxone. However her culture only grew 30,000 colonies of E. coli in 50,000 colonies of Streptococcus and get gnosis. She was fully treated for a UTI. She was successfully weaned off of oxygen onto room air on May 23 and remained stable overnight into the day of discharge. She was seen by physical therapy due to her history of ambulatory dysfunction and rehab was recommended for her. However the patient refused she felt that she had enough family support and assistance at home to return home. Home services were also recommended including home physical therapy which the patient also declined. She will need to follow-up with her family doctor in the next 7 days. A referral for pulmonology was also made on the day of discharge for 1-2 days.
87 2021-05-27 slurring, weakness Pfizer-BioNTech COVID-19 Vaccine EUA: patient with generalized weakness since immunization. Two days... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient with generalized weakness since immunization. Two days after vaccination became dysarthric. Three days after vaccination became minimally responsive and brought to emergency department (ED) by ambulance. On arrival patient had right lower extremity weakness, right upper extremity mild drift, and severe dysarthria. Patient underwent thrombectomy and did not have residual neurologic deficits. Initiated on antiplatelet agent, anticoagulation, and cholesterol-lowering agent. Patient also experienced NSTEMI and newly diagnosed with heart failure and initiated medications for management. Patient discharged medically stable. Three days later patient admitted for atrial fibrillation with rapid ventricular response and worsening ischemia: initiated antiarrhythmic medications and patient improved and discharged medically stable.
87 2021-06-03 weakness, nerve pain 1) Sudden Blurring of vision, lasting more than one month (still occurring), 2) partial loss of hear... Read more
1) Sudden Blurring of vision, lasting more than one month (still occurring), 2) partial loss of hearing in both ears, 3) nerve sensitivity when moving body and when objects (seats, walls, bed) touch skin, feeling like shooting pain on contact. 4) loss of muscle strength, and extremely sharp pain (like spear stabbing) when using muscles (see symptom #3 above). 5) fatigue and spontaneously falling asleep, even when standing or doing dishes. 6) toe nails deformity within weeks of shot, curling and turning sideways. 7) uncontrollable leg adema, severe with water leaking out of legs.
87 2021-06-24 weakness Tiredness; Feeling so weak; Does not have much of an appetite to eat anything; This is a spontaneous... Read more
Tiredness; Feeling so weak; Does not have much of an appetite to eat anything; This is a spontaneous report from a contactable consumer (patient). A 87-years-old female patient received first dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EK4176) 0.3ml, via an unspecified route of administration, administered in Arm Right on 20Jan2021 (at the age of 87-year-old) as single dose for covid-19 immunisation. Medical history included ongoing hypertension. Concomitant medications included apixaban (ELIQUIS) taken for anticoagulant therapy from an unspecified start date and ongoing; metoprolol succinate (TOPROL XL) taken for hypertension from an unspecified start date and ongoing; amlodipine besylate taken for hypertension from an unspecified start date and ongoing; olmesartan medoxomil taken for hypertension from an unspecified start date and ongoing. Patient had no problems before with her medications. On an unknown date in 2021, the patient experienced feeling so weak, does not have much of an appetite to eat anything. She noticed on Monday it was getting worse, then she had another attack of it today. It suddenly comes on and all of a sudden she is so weak. Its like she can not balance herself out. On 01Feb2021, patient experienced tiredness. The patient underwent lab tests and procedures which included magnetic resonance imaging: cyst on her right kidney on Mar2020. MRI was done prior to the vaccine, she had been having issues with pain on her right side so they did an MRI. They told her she has a cyst on her right kidney. She has not taken any kind of medications for that. They want to do another MRI before doing anything. She asks, what should she do about the second dose. Patient was supposed to get the next dose on 09Feb2021. She does not really want to take it if it will do her like this. The outcome of the events so weak, does not have much of an appetite to eat anything were not recovered and the outcome of the event tiredness was unknown. Follow-up attempts are completed. No further information is expected.
87 2021-06-29 pain in extremity Minor soreness of top of left arm; This is a spontaneous report received from a contactable consumer... Read more
Minor soreness of top of left arm; This is a spontaneous report received from a contactable consumer, the patient. An 87-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 17Mar2021 at 10:00 (at the age of 87-year-old), as a single dose for COVID-19 immunisation. Medical history included allergies(unspecified). Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient had not tested positive for COVID-19 since having the vaccine. On an unspecified date in Mar2021, the patient experienced minor soreness in the top of the left arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the adverse event. The clinical outcome of the event pain in arm was resolved on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected.
87 2021-06-29 tremor, pain in extremity, weakness urinary tract infection; Thigh pain; hip pain; vomiting; shaky; weakness; Legs collapsed on her; Leg... Read more
urinary tract infection; Thigh pain; hip pain; vomiting; shaky; weakness; Legs collapsed on her; Leg pain; fatigue; Severe headache; This is a spontaneous report from a contactable consumer. A 87-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 05Feb2021 10:00 as a single dose for COVID-19 immunization and received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 15Jan2021 16:00 as a single dose for COVID-19 immunization. Medical history included allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, Allergies to medications that contain dynacin; Allergic to Gabapentin; and has allergies to all antibiotics that end with 'cycline'. Pertinent Details Include surgical procedures and dates: She was given doxycycline which made her pass out and lose complete control of muscles and everything and put her in the hospital for 3 days. The pharmacy gave her about 5 other medications that end with 'cycline' and she was highly allergic to all of that so when she goes to the doctor she cannot take anything that has that in it. There were no concomitant medications. About a week after her second dose, she started having severe headache, pain in her legs, weakness, and fatigue. At one point, she collapsed because of weakness in her legs. Caller said they have gone to their HCP 6 times: 3 times with their urgent care doctor, 2 times with doctor, and 1 time in the emergency room. She wanted to know what to do with the adverse events. On 04Feb2021 she was diagnosed with a urinary tract infection (UTI) and started on Cephalexin 7 day therapy as antibiotic and Phenazopyridine for pain with the UTI. On 14Feb2021 she saw her primary care doctor for severe headache. She was sent to the emergency room for the severe headache where she had a CAT scan in case she was having a brain bleed or stroke, but everything checked out just fine, they thought they were safe. On 16Feb2021 she was seen and had urine testing that showed the UTI she had had not cleared up, it had worsened. She was prescribed Ciprofloxacin 10 day antibiotic therapy for the UTI but only took Ciprofloxacin for 8.5 days because of all the side effects she was experiencing. On 22Feb2021 she saw her primary care physician for leg pain, weakness, fatigue and the same severe headache that she was seen for on 14Feb2021. On 22Feb2021 she was prescribed Cyclobenzaprine as a muscle relaxer and Tramadol as pain medication. Before she took any of the Cyclobenzaprine or Tramadol on the night of 22Feb2021 her legs collapsed on her. On 24Feb2021 they called the doctor and told them that she had collapsed again and he said to stop the Cyclobenzaprine and changed Tramadol dose to half strength. She started being shaky. On 26Feb2021 they called the doctor back because she had the same symptoms with the addition of vomiting. They said to stop the Tramadol and start taking Tylenol. On 27Feb2021 they went back to the urgent care for the same symptoms as well as leg pain, thigh pain, hip pain, being real shaky and real weak. Each time they were seen by the doctor or at urgent care they drew blood and said everything was ok. On 02Mar2021 they started thinking maybe it's the Pfizer COVID-19 Vaccine. She called to ask if these events are side effects of the Pfizer COVID-19 Vaccine. Her bloodwork was fine, her urine tests since after 16Feb2021 are fine, the CAT scan showed her head is fine; but she still has severe weakness; she was walking with a cane now and before she was very active. The patient was treated with cyclobenzaprine: 5mg strength. Lot/NDC/Expiry: Unknown, product dispensed in pharmacy vial. Pharmacy label use by date is 22Feb2022; Tramadol: 50mg strength. Lot/NDC/Expiry: Unknown, product dispensed in pharmacy vial. Pharmacy label use by date is 22Feb2022. There are only 2 tablets missing from the bottle so caller believes patient took 1 whole tablet once, and then 1/2 tablet 2 different times and started vomiting so Tramadol was stopped; Tylenol 8 Hour Arthritis: 650mg strength. Lot: SBA002, Expiry: Dec2022; UPC: Unknown, there is no UPC or barcode on the bottle she has with her, but there is a little kind of icon with a stamp with some numbers above it; Phenazopyridine: 100mg strength tablets, Ciprofloxacin: 500mg strength, Cephalexin: 500mg strength. Outcome of the events was unknown. Medications that contain dynacin: Lots/NDCs/Expiries: Unknown, they do not have products, this occurred in before patient moved about 1 year ago. Gabapentin: Lot/NDC/Expiry: Unknown, they do not have the product, this occurred before patient moved about 1 year ago. Doxycycline: Lot/NDC/Expiry: Unknown, they do not have the product, this occurred before patient moved about 1 year ago. Antibiotics that end with 'cycline': Lots/NDCs/Expiries: Unknown, they do not have products, this occurred before patient moved to about 1 year ago. Reported patient was diagnosed with a urinary tract infection (UTI) and started on Cephalexin 7 day therapy as antibiotic and Phenazopyridine for pain with the UTI. On 16Feb2021 she was seen and had urine testing that showed the UTI she had had not cleared up, it had worsened. She was prescribed Ciprofloxacin 10 day antibiotic therapy for the UTI but only took Ciprofloxacin for 8.5 days because of all the side effects she was experiencing. Urine tests since after 16Feb2021 are fine. Phenazopyridine: 100mg strength tablets. Lot/Expiry: Unknown, caller does not have the bottle but has the receipt with an NDC# Ciprofloxacin: 500mg strength. Lot/Expiry: Unknown, caller does not have the bottle but has the receipt with an NDC: #.Cephalexin: 500mg strength. Lot/Expiry: Unknown, caller does not have the bottle but has the receipt with an NDC: #. No follow-up attempts are possible. No further information is expected.
87 2021-07-01 weakness Pt.'s daughter reports 03/29/2021 pt. started experiencing symptoms of dizziness, nauseous, dry mout... Read more
Pt.'s daughter reports 03/29/2021 pt. started experiencing symptoms of dizziness, nauseous, dry mouth, fatigue, severe headaches, and confusion. On and off symptoms daily until 05/10/2021 severe weakness ER (by ambulance) confirmed Stroke. Bed-riddened currently and still severe confusion.
87 2021-07-04 bell's palsy Bells Palsy left side of face- paralysis was seen in the ER on 5/31. Was seen on 6/17 by PCP due to ... Read more
Bells Palsy left side of face- paralysis was seen in the ER on 5/31. Was seen on 6/17 by PCP due to left ear pain was ordered steroids and to increase Gabapentin
87 2021-07-17 inability to speak, paralysis, feeling cold blood on her brain/clot on her brain; clot on brain and patient was in the hospital for 6 days; brai... Read more
blood on her brain/clot on her brain; clot on brain and patient was in the hospital for 6 days; brain stroke; high blood pressure 220; headache on and off since she got the vaccine; was very sleepy; used to get cold; Paralyzed; can not talk; can not walk; she is bed ridden right now; her throat is not working good; This is a spontaneous report from a contactable Consumer (patient daughter). A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection. Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in arm on 27Mar2021 as dose 1, single for COVID-19 immunization (between 14:00-15:00) Medical history included the patient had ongoing high blood pressure when the patient was young but and was not taking high blood pressure medicines as did not need it and she had borderline pre diabetic and was supposed to take medication for pre diabetes but the patient was with the caller and her kids and always only takes Vitamin D and diet intake and controlled it like that. The patient had not taken medication for years. History of all previous immunization with the Pfizer vaccine considered as suspect reported as 1st dose. No additional vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. No adverse event reported prior to vaccination. The patient was hiding because she did not want the vaccine. The patient never went to the doctor, because the patient was very healthy before vaccination. The patient hates vaccines and did not want it and that is why such a hard time that day. Time of onset of adverse events they went to the hospital and realized The patient was like that at 10:30. The patient got the vaccine 27Mar2021, (Saturday) and the headache started (Monday)on 29Mar2021, that the headaches were always in the morning, The patient would wake up and they were on and off in the mornings. The patient was very sleepy and thinks that was because of the headaches, they were very strong headaches. When they used to give babies vaccines they would get sleepy and she thinks its the vaccine and to just lay down here and would put her on her bed and she laid down with the headache and she gave Motrin and she would fall asleep. The patient used to get cold and would put blankets on her and she would fall sleep and it was on and off and states for 2 weeks it was probably 3-4 times a week. The patient had blood on brain and was hospitalized with high blood pressure 220 on Mar2021 when she was at the hospital and had the brain stroke 10Apr2021, clot on brain and the patient was in the hospital for 6 days. The patient cannot talk and walk, bed ridden right now and paralyzed on an unspecified date in Mar2021. The patient was bed ridden right now on an unspecified date in Mar2021 and her throat was not working good on Mar2021. She had headache on and off since got the vaccine on 29Mar2021 and was very sleepy on an unspecified date in Mar2021, used to get cold on an unspecified date in Mar2021. Caller did not recall the day she was released. It was reported that, now she was ok. They did physical therapy for 2 months to see if they can bring back but were not able to. The patient was kinda like stuck and the only thing. The patient improved they removed the IG tube. The patient was eating through and she was now eating thick foods as throat was not working good, like baby food blended. States the card has the clinic site and when to go for the 2nd dose but she did not go back because of this. It was reported that, when they went to the hospital that day with the clot on brain the doctor asked if she had any bad news or any type or received anything thinks because of the high blood pressure was why he was asking. The patient was fine and watching TV and had a headache on and off since got the vaccine. The reporter stated that she told the doctor she got the vaccine 2 weeks ago and the doctor said it was the vaccine. The reporter stated that the patient did not know what testing was done, they were trying to give something for the clots from brain without getting surgery but it was not working and pressure was so high and the clots would not move, it was not able to do it. The patient did not know what they did but the other option was to remove the clots. The patient visited to emergency room and did not went to Physician Office. The patient was planning to take her to the doctor because of the headaches but was so busy and was having a project at work. The patient underwent lab tests and procedures which included blood pressure measurement: 220 mmhg on Mar2021 when she was at the hospital. The outcome of the event oropharyngeal discomfort was not resolved and outcome of the other events were unknown. Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.
87 2021-07-17 brain damage admitted for encephalopathy secondary to bilateral pneumonia
88 2021-01-03 unresponsive to stimuli Resident unresponsive. Responds to painful stimuli. Arms flacid.
88 2021-01-07 hot flush ON 1/5/21 AT 12:30PM, DEVELOPED HOT FLASHES THAT LASTED 20 MINUTES BEFORE RESOLVING.
88 2021-01-11 tingling Pt reports fatigue and bilateral lower extremity paresthesia. No focal neurological findings.
88 2021-01-11 tenderness Red, Tenderness
88 2021-01-12 seizure Systemic: Seizure-Severe
88 2021-01-18 pain in extremity, feeling hot Body aches, sore arm, chills, feeling hot Treated with Tylenol
88 2021-01-20 pain in extremity sore arm; lightheaded and kind of dizzy; Her stomach doesn't feel great ("stomach isn't the best"); ... Read more
sore arm; lightheaded and kind of dizzy; Her stomach doesn't feel great ("stomach isn't the best"); Dry mouth; nausea; This is a spontaneous report from a contactable consumer (patient). This 88-year old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 09Jan2021 the patient experienced sore arm. Since an unspecified date in Jan2021 she was lightheaded and kind of dizzy, her stomach did not feel great, she had dry mouth and nausea. She was feeling as if she could get sick (further specified as nausea). She had not got sick but her stomach wasn't the best. Events outcome was unknown. Information on the lot/batch number has been requested.
88 2021-01-24 pain in extremity, hot flush Extreme nausea, hot flashes, dizziness, strange head, fatigue, nasal congestion, sore throat, runny ... Read more
Extreme nausea, hot flashes, dizziness, strange head, fatigue, nasal congestion, sore throat, runny nose, sneezing, sore arm,
88 2021-01-25 feeling hot 1 week after vaccine, developed 11x9 cm area of erythema, warmth, and swelling. Pt reported it was i... Read more
1 week after vaccine, developed 11x9 cm area of erythema, warmth, and swelling. Pt reported it was itchy but not painful.
88 2021-01-25 pain in extremity R arm pain headache
88 2021-01-29 pain in extremity Mild headache, diarrhea, nausea, vomiting, sore arm
88 2021-01-31 pain in extremity terrible pain in the shoulder and arm, difficulty with arm movement, inability to raise arm to the l... Read more
terrible pain in the shoulder and arm, difficulty with arm movement, inability to raise arm to the left, needed a small pillow to support shoulder to go to sleep that night
88 2021-02-01 tremor Patient was out of breath after walking down to clinic from her room. She said she just needed to ca... Read more
Patient was out of breath after walking down to clinic from her room. She said she just needed to catch her breath and was given a few minutes to sit prior to vaccination. Pharmacist asked her if she felt okay today, which she replied yes. She stated the nurse assisting her down the hall was walking to fast for her. After her vaccination patient remained seated for 20 minutes and still reported shortness of breath. A pulse ox was placed on her finger and her pulse was ranging between 44-80 and O2 range was 94-98. When her pulse rate would drop, she had uncontrollable body tremors. EMS was dispatched within an hour after vaccination and patient was transported to the ED.
88 2021-02-02 pain in extremity Dizziness; Pain in the lower extremities; pain in feet; legs hurt; Felt poorly; Blood pressure which... Read more
Dizziness; Pain in the lower extremities; pain in feet; legs hurt; Felt poorly; Blood pressure which was up a little but not terribly; Left arm where she got the injection was sore (localized pain); This is a spontaneous report from a contactable consumer (patient's sister). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249), via an unspecified route of administration in left arm, on 13Jan2021 07:45, at a single dose, for COVID-19 immunization. The patient's medical history included atrial fibrillation, hypertension, bypass in 2010, hearing is very bad on the phone, arthritis pain, headache, and blood thinner. The patient's concomitant medications included metoprolol for hypertension, quinapril for hypertension, acetylsalicylic acid (BABY ASPIRIN) for hypertension, ascorbic acid/ calcium/ minerals NOS/ retinol/ tocopheryl acetate/ vitamin B NOS/ vitamins NOS/ zinc (CENTRUM SILVER), calcium carbonate (CALTRATE), atorvastatin, warfarin as blood thinner, spironolactone, and paracetamol (TYLENOL) for arthritis pain and headache; all were ongoing. The patient received the first dose of the BNT162B2 vaccine on 13Jan2021 and had reactions to the vaccine or something else. That day, the patient's left arm where she got the injection was sore (localized pain), but that was expected, and it went away within 2 days (initially didn't report it because it was expected). Yesterday (18Jan2021), the patient experienced dizziness and pain in the lower extremities. Last night (18Jan2021; about 6 days after the injection), the patient woke up, felt poorly, and was very dizzy (feeling of dizziness), then, later on, had pain in both lower extremities. The patient took her blood pressure which was up a little but not terribly with result of 159. The patient's heart rate, temperature, and pulse oximetry were okay on 18Jan2021. She then walked to the bathroom, came back, and went back into bed. The second time she said her legs hurt but this morning she is feeling better than she was. Today (19Jan2021), the pain in feet is better, and the dizziness is gone. Pulse oximetry and temperature were okay this morning (19Jan2021). The patient was wondering if these effects could be related to the vaccine, since the dose was received 6 days ago. The patient was not sure if could possibly be related to the COVID-19 vaccine or if it was that she spent a lot of time doing paperwork on the computer yesterday (18Jan2021) and perhaps that caused some of the symptoms. The patient's sister called to ask if Pfizer has heard of any late adverse effects from the COVID-19 vaccine like this patient's, 6 days later. The patient was scheduled to get the second dose on 04Feb2021 (day 22) and her sister asked what if it's not available. The patient's sister was concerned about interval and potentially being unable to gain access to the second dose due to supply issues. The patient recovered from "Left arm where she got the injection was sore (localized pain)" on 15Jan2021; and from "Dizziness" on 19Jan2021. The patient was recovering from the other events.
88 2021-02-03 inability to speak Right after leaving hospital. Pain down back of left side down to knee. After an hour or so, it wen... Read more
Right after leaving hospital. Pain down back of left side down to knee. After an hour or so, it went away. Then, next day, many aches and pains; Chest pain and aphasic; Called 911. EMS came and examined her. They stayed awhile. Gave her liquids. Pt slept rest of day Saturday. Next day, Sunday, she still had some minor symptoms. On Monday, she felt better.
88 2021-02-04 inability to speak 1/27/2021 developed increased fatigue, required increased assistance with ADLs. Continued with func... Read more
1/27/2021 developed increased fatigue, required increased assistance with ADLs. Continued with functional decline and overall decline in mentation. Has impacted functional level (requiring increased assistance with feeding, bathing, dressing, toileting) and speech/swallow ability. Decreased ability to respond/converse with staff
88 2021-02-04 seizure Systemic: Seizure-Severe
88 2021-02-07 flushing flushed in the face/warm; red face; tingling sensation of lips but no swelling; mild allergic reacti... Read more
flushed in the face/warm; red face; tingling sensation of lips but no swelling; mild allergic reaction; This is a spontaneous report from contactable consumers. An 88-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 20Jan2021 11:45 at single dose (left arm) for COVID-19 immunization. Medical history included lung cancer. The patient was not pregnant. Concomitant medications were not reported. It was reported that the patient had unspecified other medication in two weeks. The reporter's mother's experienced mild allergic reaction in Jan2021 and she wants to know whether or not she should be getting her second dose. She will be asking her doctor as well as they were advised by the nurse administering the vaccine and also the doctor's nurses who observed her mother afterwards, but she was also advised to contact Pfizer. On 20Jan2021, at 12:00, within 5 minutes, the patient experienced flushed in the face/warm, red face, tingling sensation of lips but no swelling, no increased blood pressure, no hives or rash, no tongue or throat swelling, no dizziness, no nausea. It was mild but concerning. The patient was treated with oral Benadryl and Pepcid IV (also reported as IV of peptids), and extended observation for 1 hour and 30 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had no Covid prior vaccination and was not Covid tested post vaccination. The consumer would like to know if her mother was safe to receive the second dose of the Covid vaccine and if the reaction to the second dose of the Covid vaccine will be more severe with a history of an allergic reaction to the first dose. Outcome of event mild allergic reaction was unknown; outcome of the rest of events was recovered in Jan2021. Information on the lot/batch number has been requested.
88 2021-02-08 inability to speak I had a violent reaction; lesion on my brain and found everything once I was in hospital; I am upset... Read more
I had a violent reaction; lesion on my brain and found everything once I was in hospital; I am upset; Dizziness; Vomiting; the "rungs" (not clarified) and the stomach after giving me something it stopped. I went from both ends when I had to throw up I just went out from both ends, (it was) bad; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received first dose of bnt162b2 (BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunization. Medical history included diabetes, blood pressure high, thyroid. Concomitant medication included amlodipine, valsartan (DIOVAN), metformin, levothyroxine sodium (LEVOXYL) for thyroid, atorvastatin (LIPITOR). The patient had the shot on Saturday and Sunday, she had a violent reaction and she just want to report it. It was first shot she had the first on Saturday and it happened (incomplete sentence). Her follow up was that she found other problems. She found lesion on her brain, she found everything else once she was in the hospital. So actually this reaction was (incomplete sentence). She known never she was little upset today. She was not right why not follow up latter she was little upset today, so she just want to let you know she had a problem. When probed for the vaccination date, consumer stated, the date was 23Jan2021. When probed for start date of the events, consumer stated, it was 24Jan. When probed for the side effects, consumer stated, she had extreme dizziness, she had extreme vomiting and "run" (not clarified) and that was about it Dizziness she went to 12 o'clock noon she started with the dizziness and it was over in about 5 in the afternoon and the "rungs" (not clarified) and the stomach after giving her something it stopped. She went from both ends when she had to throw up she just went out from both ends, (it was) bad. They did not give her anything for that. They did all sorts of test and found out that she had other problems. When probed for any Laboratory test, consumer stated, "Yes, she did it and she was fine." When probed for laboratory results, consumer stated, "No, she did not have the results. Her doctor just gave them to her over the phone and said that she was good. Her A1C was 5.9." The event lesion on her brain was reported as serious per hospitalization. The patient underwent lab tests and procedures which included glycosylated haemoglobin: 5.9 on an unspecified date. The outcome of events was unknown.
88 2021-02-08 numbness, speech disorder, tremor Patient experienced moderate to severe symptoms of shaking, trouble breathing, jaw tightness, tightn... Read more
Patient experienced moderate to severe symptoms of shaking, trouble breathing, jaw tightness, tightness in mouth, numbness and tingling in lips, difficulty talking, upset stomach, tremors and numbness to left side of face
88 2021-02-09 weakness, slurring Was admitted to hospital on January 24th for unexplained weakness and dizziness - I noticed she was... Read more
Was admitted to hospital on January 24th for unexplained weakness and dizziness - I noticed she was slurring her speech starting around the 20th of January. Hospital could not determine cause and she was released into nursing facility on the 28th. Did not recover. Received her second dose of Pfizer Covid vaccine at nursing home on Feb 4th. Starting having symptoms of slurred speech and became more weak. Labs on Feb 6th indicated very low hemaglobin levels and was admitted to the hospital on Feb 6th for transfusion. She is requiring transfusions of blood and iron. Possible ITP?
88 2021-02-09 weakness severe headache along backside of head from ear to ear; Overall feeling weak, tired, and body aches;... Read more
severe headache along backside of head from ear to ear; Overall feeling weak, tired, and body aches; Overall feeling weak, tired, and body aches; Overall feeling weak, tired, and body aches; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3248) via an unspecified route of administration in the right arm on 20Jan2021 10:30 AM at a single dose as COVID vaccine. Medical history included known allergies to crab, sulfur, penicilin. Concomitant medications (other medications in two weeks) included warfarin sodium (COUMADIN), acetylsalicylic acid (ASPIRIN LOW), lisinopril. No other vaccine in four weeks. On 21Jan2021 11:00 AM, beginning about 24 hours after injection - severe headache along backside of head from ear to ear. Overall feeling weak, tired, and body aches on 11:00 AM. Lasted about 20 hours. Treatment was not received for the events. She had no COVID prior to vaccination. She has not had COVID tested post vaccination. The outcome of the events was recovered on Jan2021.
88 2021-02-09 tremor Systemic: Chills-Severe, Systemic: Fainting-Severe, Systemic: Other- High heart rate, 121 BPM, high ... Read more
Systemic: Chills-Severe, Systemic: Fainting-Severe, Systemic: Other- High heart rate, 121 BPM, high anxiety, body shaking chills, passed out for about 30 seconds, was able to speak and breath normally
88 2021-02-10 mild one side paralysis, unresponsive to stimuli, tremor COULD NOT STAND OR WALK, KEPT HER EYES CLOSED, LEANING TO ONE SIDE, SHAKING, COULD NOT FEED HERSE... Read more
COULD NOT STAND OR WALK, KEPT HER EYES CLOSED, LEANING TO ONE SIDE, SHAKING, COULD NOT FEED HERSELF, COULD NOT UNDERSTAND COMMANDS OR CUES, COULD STAND TO CHANGE BRIEF OR PULL HER PANTS DOWN, COULD NOT DRINK...LIKE SHE FORGOT HOW, WOULD NOT STAND TALL WITH SOMEONE HELPING, DID NOT KNOW HOW TO PICKUP FORK. VERY AMBULATORY, FED YOURSELF, DRESSED HERSELF UNDERSTOOD COMMANDS BEFORE THIS HAPPENED
88 2021-02-15 pain in extremity Physician, patient's son, and husband standing at patient's side throughout event. Within 5 minutes ... Read more
Physician, patient's son, and husband standing at patient's side throughout event. Within 5 minutes of receiving the 2nd COVID 19 vaccine, the patient began to report that she was feeling sharp shooting pains in her legs, arms and chest. The patient reported feeling anxious prior to the injection. Within 6-7 min, the patient began to experience difficult breathing at which time 911 was called. The patient was given 1 dose of Epi and one dose of Benadryl IM, which eased severity of the symptoms. The patient's vital signs remained within normal limits until time of transport to local hospital.
88 2021-02-16 pain in extremity Fall; fatigued; arm pain; AML; Sepsis secondary to AML; This is a spontaneous report from a contacta... Read more
Fall; fatigued; arm pain; AML; Sepsis secondary to AML; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 19Jan2021 17:30 in right arm at single dose for covid-19 immunization. Medical history included hypertension, hyperlipidemia, OA (osteoarthritis), cognitive impairment. No other vaccine in four weeks was administrated. Concomitant medication in two weeks included atorvastatin, aspirin, calcium, gabapentin, losartan and memantine hydrochloride (NAMENDA). The patient previously took lisinopril and tetracycline and both experienced allergies. The patient had no covid prior vaccination. The patient initially had no symptoms but arm pain in Jan2021, no bleeding or bruising from injection. On 31Jan2021 19:00, patient felt fatigued. Patient suffered fall on 01Feb2021. She was admitted to hospital. All cell lines were down in Feb2021. She was diagnosed with AML (acute myeloid leukemia) in 2021. She expired 07Feb2021. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event) and patient died. The patient received the treatment of blood and platelet transfusions, bone marrow biopsy, cytogenetic testing, antibiotics, intubation for events. The patient died on 07Feb2021 due to sepsis secondary to AML. An autopsy was not performed. Outcome of events were fatal.; Reported Cause(s) of Death: arm pain; fatigued; fall; Sepsis secondary to AML; Sepsis secondary to AML
88 2021-02-17 seizure Patient was sitting in observation area after vaccination when she began seizing. Patient was taken... Read more
Patient was sitting in observation area after vaccination when she began seizing. Patient was taken to the emergency department.
88 2021-02-18 numbness C/O Left leg numbness. Pt has family with her. Refuses transfer, patient able to bear weight. 1... Read more
C/O Left leg numbness. Pt has family with her. Refuses transfer, patient able to bear weight. 1007 am BP - 120/90, Pulse 85 (RA), 02 -98% 1009 am BP 192/92 LA
88 2021-02-21 burning sensation 4 days after receiving the vaccine on 1/31, she experienced burning in her legs and feet; a few days... Read more
4 days after receiving the vaccine on 1/31, she experienced burning in her legs and feet; a few days later she had some SOB with activity (walking up stairs), lethargy and "tired" feeling in her arms and legs - all of these symptoms persist
88 2021-02-24 tremor, tingling, pain in extremity, numbness, feeling cold Patient experienced numbness and tingling to left side of face, tremors, sharp shooting pain in the ... Read more
Patient experienced numbness and tingling to left side of face, tremors, sharp shooting pain in the left temporal area, left upper arm sore shoulder to elbow. Patient was also extremely cold so treated her with warm blankets. Gave patient water and checked blood pressure and hooked her up to heart monitor. Blood pressure was 138/74, pulse 60 and respirations 24. No mediacations were given while in our care. Continued to monitor paient for 2 hours at the clinic site. Patient did not want to go to the hospital
88 2021-02-24 unresponsive to stimuli Pale, Short of Breath, Hypoxic, Lethargic within minutes became unresponsive and died.
88 2021-02-25 slurring Extreme Fatigue, slurring speech, unable to stand, eat. Death on 2/5/21
88 2021-02-25 muscle spasms 2nd Shot Feb 12. No side effects till 6th day -Feb 18 lower back pain. Feb19 extreme cramping in upp... Read more
2nd Shot Feb 12. No side effects till 6th day -Feb 18 lower back pain. Feb19 extreme cramping in upper right thigh and right calf by shinbone. Feb20 same cramping as above described plus pain had moved to outer right hip muscles. Pain improving Very slowly till feb 26 one week later. still have pain in hip muscles on right back outer area.
88 2021-03-04 tingling extreme lightheaded began approximately 2/28/21. tingling in left ear at bedtime, feel like my ears... Read more
extreme lightheaded began approximately 2/28/21. tingling in left ear at bedtime, feel like my ears are stuffed as well as my head feeling that way, unsure is I should receive the second shot
88 2021-03-07 pain in extremity lightheadedness, not sure of her footing and not walking as forcefully as usual; When she turned aro... Read more
lightheadedness, not sure of her footing and not walking as forcefully as usual; When she turned around she felt like she didn't have control.; lightheadedness, not sure of her footing and not walking as forcefully as usual; When she turned around she felt like she didn't have control.; lightheadedness, not sure of her footing and not walking as forcefully as usual; When she turned around she felt like she didn't have control.; arm hurt a little; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9263), on the right arm, via an unspecified route of administration on 25Jan2021 at 13:45 at single dose for COVID-19 immunisation. Medical history was reported as none. No family medical history. Concomitant medication included denosumab (PROLIA) given on 06Jan2021. No additional vaccine administered at the same date as BNT162B2 and no prior vaccinations within 4 weeks. No tests were done. On 26Jan2021, it was reported that her arm hurt a little but not much. A day or so later on 27Jan2021, the patient started to experience a lightheadedness, not sure of her footing and not walking as forcefully as usual. When she turned around she felt like she didn't have control. Adds she felt like she walking through a field of marshmallows. She is scheduled to receive the next dose of the vaccine on 15Feb2021 at 14:00. The events did not require physician office or emergency room visit. The vaccine was administered in a school. The outcome of the event arm hurt a little was recovered on 27Jan2021 while for the rest of the events was recovering.
88 2021-03-11 weakness Patient felt weak and nauseated, was hypotensive and heart rate was 41. Patient was pale but respons... Read more
Patient felt weak and nauseated, was hypotensive and heart rate was 41. Patient was pale but responsive. Ambulance was called, patient taken to Hospital Medical Center via ambulance.
88 2021-03-11 tremor 08:37 Vaccine administered. Observation time increased to 30 minutes related to history of anaphylax... Read more
08:37 Vaccine administered. Observation time increased to 30 minutes related to history of anaphylaxis. 08:50 Patient shaking and stating she needs O2. Pt placed on monitor. O2 sat 99% on room air. Patient and daughter requesting O2. Patient placed on O2 at 2L via nasal cannula. 09:05 Pt registered as ED patient. Care assumed by doctor and registered nurse. Patient monitored as ED patient and released home in stable condition.
88 2021-03-13 pain in extremity Breathing problem. Couldn't get air in. Had fever of 103, headache, chills. Arm pain as expected,... Read more
Breathing problem. Couldn't get air in. Had fever of 103, headache, chills. Arm pain as expected, swelling red and raised hot area. table salt for breathing p roblem and it helped me breathe. I was not well for over 2 days. 3rd day I began to feel better but 100% day 4. Please note I would never have made it to the hospital alive, not being able to breathe. I did not get the 2nd shot!!
88 2021-03-15 hot flush, flushing Pt received Pfizer COVID-19 vaccine on 3/5/21, and on 3/9/2021 she started experiencing flushed, hot... Read more
Pt received Pfizer COVID-19 vaccine on 3/5/21, and on 3/9/2021 she started experiencing flushed, hot hands, forearms and also chest. She also had a very slight pinkish tone to the affected skin. It disappeared within 2 hrs but then returned in the AM. 3/11 the symptom extended to chest area. The patient also started Sertraline 50mg 3/5/21, same day as vaccine administration. They contacted PCP and she did not believe the rxn was due to the Sertraline. As of 3/15/21 the symptoms have subsided.
88 2021-03-16 depressed level of consciousness Pt. was vaccinated on 3/17/21 at 0924. At 0940, pt. had bounded carotid pulse and decrease level of ... Read more
Pt. was vaccinated on 3/17/21 at 0924. At 0940, pt. had bounded carotid pulse and decrease level of consciousness. Pt. progressed to having no pulse and chest compressions were given for about 1 minute. Pt. was given 6L of O2 and 9-1-1 was called. Pt. regained consciousness at 0945. BP 140/90, HR 62. Ambulance arrived at 0953 and pt. was assessed by EMT. Pt.?s daughter provided pt.?s medical history. Pt. has history of passing out, atrial fibrillation and seizures. Pt. left via ambulance at 1003.
88 2021-03-18 weakness She got the vaccine, and had no problems until Wednesday 3/17/21 at 3:00 AM she started coughing and... Read more
She got the vaccine, and had no problems until Wednesday 3/17/21 at 3:00 AM she started coughing and could not coughing. She finally got up and went into the bathroom and by 3:30 had coughed up little round, clear jellyfish. Then she stopped coughing and went back to bed for 15 minutes, and then at 3:45 started getting diarrhea which she had until 10:30 AM. She called Pfizer and reported her reaction and talked to them. During that time she had a lot of diarrhea and her body was starting to ache, joints and muscles. She did not take her temperature and went back to bed, and slept until she could get up and go to the bathroom. She then took her temperature and it was 100.7, which her normal is 97. 3. She slept from 11:00 PM Wednesday until 11:00 AM Thursday. She could not stay awake for long before falling back to sleep. Yesterday she did sleep most all of the day, and did not eat anything since Tuesday evening and did have a piece of toast yesterday. Today, 3/19/21 she is able to get up, dressed and gotten downstairs to get something to eat and has lost 6# in this time period. She is feeling wimpy, and her temp is down to 97.3, her pulse ox is 98%, pulse in the 70s. She's achy, and has rubbed on Aspercreme and has taken Tylenol a couple of times. She is still very weak, probably dehydrated and going to get something to eat as she has just gotten up. She is foggy thinking, but feels that once she rests, eats and gets strength she will be fine.
88 2021-03-26 tremor Patient developed shakiness in legs while waiting in line due to standing too long. Taken to medical... Read more
Patient developed shakiness in legs while waiting in line due to standing too long. Taken to medical observation at 1036 for vaccine administration and for assessment. BP 124/62 HR 82 RR 16 At 1046 patient had resolution of symptoms She self administered 2 glucose tablets while in observation.
88 2021-03-31 weakness weak and fatigued
88 2021-04-01 pain in extremity She needs to get her magnifying glass, she states she's going blind/macular degeneration; She needs ... Read more
She needs to get her magnifying glass, she states she's going blind/macular degeneration; She needs to get her magnifying glass, she states she's going blind/macular degeneration; temperature 99.2; vomiting; very tired; arm was sore, couldn't lay on it; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9809) intramuscularly, administered in left arm on 23Feb2021 at 10:30 (at age of 88 years old) at a single dose for COVID-19 immunization; gabapentin, via an unspecified route of administration from 08Feb2021 to 15Feb2021 at 100 mg, daily, then via an unspecified route of administration from 15Feb2021 (Batch/Lot number was not reported; Expiration Date: 08Feb2022) to an unspecified date, at 200 mg, daily for feet burn. Medical history included hiatus hernia surgery from Nov2019, surgery from an unknown date, vomited after surgery for three nights/days, gastrooesophageal reflux disease (GERD), cancer, feet burning, feet red, asthma and thyroid. Concomitant medication included paracetamol (TYLENOL EXTRA STRENGTH), fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma, montelukast sodium (SINGULAIR), fluid pill, vitamin D, vitamin C, potassium, acid reflux pill before nighttime before supper, thyroid pill, singulair pill. The patient previously took Codeine and percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced allergies. Two years before in Nov2019 she had hiatus hernia surgery. Her stomach went into her chest. She was in rehab. She had to have the surgery done twice. She went from one hospital and then she went to another and it was taken care of there. When she went to rehab after her surgery, all she did was vomit day in and day out. Her current vomiting reminds her of this experience. They finally did take care of it. She came out of the hospital and was vomiting. She clarifies she had problems with vomiting for the last 6 months before this current experience. She doesn't know what she's eating. They say it's acid and she has Gerd. She does try to get her exercises in. When she was in the hospital, they found she had cancer, which they are just watching for now. When querying what kind of cancer she has, the caller explains she didn't have them do a biopsy. She didn't want to go that far into it. She didn't want any extensive treatment. At first, they were keeping check of the cancer every 3 months. Now, she is going ever year. She last went in November. The patient experienced macular degeneration on an unspecified date, vomiting on 23Feb2021 at 17:30, temperature 99.2 on 25Feb2021 at 10:00, very tired on 23Feb2021, arm was sore couldn't lay on it on 23Feb2021. Patient had the first Covid vaccine Tuesday morning, clarified to 23Feb2021 at 10:30AM and around 5:30PM that night she started vomiting. She vomited all night long and all day Wednesday and Wednesday night, and this morning. So far, it had stopped. She was trying to hold water down, but she couldn't keep water down, the water would come up. She clarifies further she tried to take a sip but it kept coming up. She called her doctor who was a practitioner and she told her to drink ginger ale and maybe crackers. She told the doctor that her daughter sent her electrolytes and she was told that was fine to take. She tried toast this morning and she couldn't hold it down. She's been eating very slow, taking little bites at time and she had been holding it down. She did have temperature of 99.2 on 25Feb2021, but half hour or so before it was down to 96 now. She couldn't take medicine that she normally takes because she'll throw it up anyway. She tried to take a few of her pills but it didn't stay down, she threw them up. Around 9am, she took her thyroid and that stayed down. So far, that's doing good. She takes Advair for asthma and she took that, that's okay. She took her singulair pill. So far, the three of these medications have stayed down, and she took 2 Tylenol. Patient took Tylenol twice. She knows it was Extra strength, took 2 pills Tuesday night but it didn't stay down. She Took 4 Tylenol today, 2 pills this morning and 2 right before her CNA left at around 3pm. Caller mentions she can't see the dosage on her Tylenol bottle. She doesn't see the dose. She mentions she will get her magnifying glass to check it out. She's afraid because she had surgery a couple years before and she vomited after surgery for three nights/days, or whatever. Today (25Feb2021), when she spoke to her doctor she was advised to call Pfizer to let them know how the vaccine is affecting her. Right now, she feels pretty good, but she was very, very tired. She's going to lay down when she gets off the phone. She had a CNA with her today and she also spoke to the nurse practitioner. The last time she vomited was around 10am. When the CNA came in, she told the caller to call the doctor but she told the CNA she'd be fine. However, the CNA urged the caller to call her doctor and let them know what was going on. Her second dose was scheduled for 16Mar2021. Her doctor told her don't drink the water, drink the ginger ale and don't drink it too fast, and try crackers and toast. The patient took her temperature last night (24Feb2021) but couldn't read it that great, she thought it was 98. When the CNA came this morning (25Feb2021), she took it around 10:00AM and it was 99.2. She told the CNA to take another temperature because she didn't think she had a fever. When the CNA left, she had to leave at 3:00PM, her temperature was normal, it was 96. She thinks maybe her temperature went to 99.2 because she was drinking her tea. However, she wasn't drinking it right away, because she threw up on it. She stopped drinking an hour before her temperature was taken. She clarifies wasn't drinking the tea when the CNA came. She also mentions she broke up her the toast into little tiny pieces and felt like she was eating like a bird, but it didn't stay down so she stopped. The CNA came around 9am, maybe 8am, and clarifies it was maybe around 1030AM when she took the temperature. When the CNA left her temperature was at 96. The patient was very tired the same day she received the vaccine. She remembers went to bed with clothes on. Last night, she wanted to go to bed again with her clothes on but she couldn't stand it and she changed into her pajamas. Then, she went to the bathroom and vomited, she has a bucket by the side of her bed. It wasn't the dry heaves, stuff was coming up. She was still very tired currently. She makes the comment "I forget things and then I remember afterwards". She had to get under the light to see the Covid card, it's small, it is handwritten. Caller mentions she sees the month on it. Caller reports her arm bothered her for quite a while. Last night, she went to sleep on her left side and her arm was feeling better which gave her some hope. Her arm started hurting her the day she got the vaccine, but her arm wasn't red or anything. Her arm was feeling better this morning. She thinks if she can sleep on it and didn't hurt, it's getting better. The last pills she took were Gabapentin she has been on for about 2 weeks. She explains her feet burn during the night and the doctor recommended the Gabapentin for now. However, she has had too much time trying to stop the vomiting that that took over her feet burning, so her feet didn't bother her as much. She was initially prescribed 1 pill at night before going to bed at 10pm, then when the 1 pill didn't work for a week, the doctor increased it to 2 pills at bed time at 10pm because it takes an hour to work. She stated that she was going to take the Gabapentin on Tuesday night, which was a mistake because she threw it right up and it tasted awful. Caller makes the comment she has not given the doctor the report of how that reacted yet. When probed for an NDC, Lot number or expiry date for the Gabapentin, the caller explains she can't see writing, it's in small print. She does see the Discard After: 08Feb2022. She needs to get her magnifying glass, she states she's going blind. She's been told she had macular degeneration. She doesn't think the Gabapentin is agreeing with her. She reads that it "May cause drowsiness, operating vehicle which she doesn't drive, may cause dizziness, may cause vision. Call if you experience mood changes, sadness, depression.." She started out taking one pill of the Gabapentin every night from Monday to Monday. The second Monday, 15 Feb2021, she started taking 2 pills at night for a total of 200mg. She took it this past Monday night until she had the vaccine and then she took it again, and now she was not taking it anymore. Her burning feet wake her up during the night, it starts at her ankles and goes halfway up her leg. She had to put her feet on a cold floor. Normally, she feels good and she usually doesn't get pain so whatever little bit of pain she has, that's the pain she gets. Her feet were burning like that for month before she called the doctor. she didn't know. Her feet were red before they started to burn, this is the latest thing. During the day, she is fine, only a nighttime her feet burn. The patient underwent lab tests and procedures which included body temperature: 98 on 24Feb2021; 99.2 on 25Feb2021; 96 on 25Feb2021. Therapeutic measures were taken as a result of vomiting. She was going in for a test, clarified as an MRI on the 3rd of March for her eyesight. The action taken in response to the event for gabapentin was permanently withdrawn on an unspecified date. The outcome of the event "Pain in arm" was recovering, the outcome of the event fatigue was not recovered, the outcome of the events "temperature 99.2" and "Vomiting" was recovered, and outcome of other events was unknown.
88 2021-04-04 weakness Patient initially had mild flu-like symptoms after receiving her second dose. Wednesday evening she... Read more
Patient initially had mild flu-like symptoms after receiving her second dose. Wednesday evening she suddenly couldn't stand, pivot or transfer into her wheelchair or be able to get up from her handicap accessible bathroom toilet. Emergency services were called and she was taken to the hospital for testing. After 7 days in hospital she was transferred to a nursing rehabilitation facility to hopefully get her to regain muscular strength to return home. After 12 days little improvement is being seen...
88 2021-04-04 pain in extremity Patient potentially received higher than the recommended 0.3ml dose of the Pfizer vaccine. As of Sun... Read more
Patient potentially received higher than the recommended 0.3ml dose of the Pfizer vaccine. As of Sunday 4/4, patient only complaint is mild arm soreness.
88 2021-04-07 weakness, tremor I threw up my dinner that night, had 4 terrible shaking Chills over that weekend and continued chil... Read more
I threw up my dinner that night, had 4 terrible shaking Chills over that weekend and continued chill for about a week, weakness in legs, fatigue, sleeping for hours, no energy, itchy skin, no appetite (lost 8 pounds), continued mental disorientation and unusual forgetfulness, also inablity to type correctly or to tell stories that I had just rehearsed, I also lost 20% of hearing in left ear, After 5 weeks I am about 95% OK physically, but still very slow with brain power and typing.
88 2021-04-12 unresponsive to stimuli WE RECEIVED A TELEPHONE CALL AT 4:45 PM ON 1/27/21 THAT WAS NON RESPONSIVE AND A FOLLOWING CALL AT 5... Read more
WE RECEIVED A TELEPHONE CALL AT 4:45 PM ON 1/27/21 THAT WAS NON RESPONSIVE AND A FOLLOWING CALL AT 5:00 PM THAT SHE HAD PASSED.
88 2021-04-19 tingling Patient reported that three days after receiving the vaccine, she developed swelling in left leg, an... Read more
Patient reported that three days after receiving the vaccine, she developed swelling in left leg, ankle, hip, shoulder and hand. The symptoms stayed for a week and patient's leg was tingling, left hip aching, left shoulder pain, left hand feels like pins and needles, Achy all over and felt unwell.
88 2021-04-30 pain in extremity Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Got a s... Read more
Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Lips felt funny; The arm that was a little sore; This is a spontaneous report from a contactable consumer (reporting herself). A 88-Years-old white female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266, expiration date: 31 May 2021), via intramuscularly in left arm on 14Feb2021 at a dose of 0.3ml as a single dose for COVID-19 immunisation. The patient's history included allergies to Penicillin, Cortisone, and she thinks also to Lidocaine, maybe. The patient did not have any NDC numbers, Lot numbers or expiry to provide for any of these products, as it was years ago. The patient did not receive any other medications. On 14Feb2021 about an hour after she got her vaccine; the patient had waited 40 minutes after getting the vaccine shot, and nothing happened, so she left, and while she was on her way home, she got a sensation in her nose, throat and upper chest like it was warm, and there was dryness. The patient previously used to get allergy shots because she was allergic to horse flies, and within 24 hours of being bitten, she would have hives the size of dinner plates. The patient went through allergy shots for 10 years and then she moved away and was no longer near water, so she did not think she needed the shots anymore. The patient had been getting the shots for 10 years, she would start to get where her lips felt funny and stuff after getting the shot, and her reaction to the COVID vaccine, felt similar to that, but it had dissipated within a half hour. This was probably respiratory and was not major, her nose did not close up, but it did get dry. The event resolved within an hour. The patient inquired with three physicians about if she should get the COVID vaccine, because she had an anaphylactic experience 40 years ago, before she was going to the allergist, and she had to go to the ER (emergency room), and they gave her whatever they did, Epinephrine or whatever it was, but that experience felt like she was being blown up like a straw was in her body. The patient inquired with these different physicians about told them about her experience from years ago, and what their suggestion would be, and they told the patient to go for it with getting the COVID vaccine, because it anything were to happen, it would be within 15 minutes of getting the shot, but the patient's was more than 15 minutes after getting it. The patient got the hives to the horse flies, it was usually within 24 hours. The patient did take an EPIPen with her when she went to get the COVID vaccine, because she was concerned she would have a reaction, but did not end up needing to use it. The outcome of the events was recovered.
88 2021-05-04 night sweats, hot flush I thought I had the COVID; I thought I had the COVID; Flu like symptoms; Throwing up/I threw up; sic... Read more
I thought I had the COVID; I thought I had the COVID; Flu like symptoms; Throwing up/I threw up; sick/deathly sick/ ill; chills; hot flashes/hot spells; night sweats/I perspire the whole night; Sweating; I had stomach problems; I hurt all over; I fell and tore two ligaments in my hand; I fell and tore two ligaments in my hand; This is a spontaneous report from a Pfizer sponsored program and medical information team. Two contactable consumer (one of them was patient herself) reported that an 88-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206), via an unspecified route of administration in right shoulder on 11Mar2021 (at the age of 88-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included blood pressure high, thyroid, cholesterol, sleep. Concomitant medications included apixaban (ELIQUIS) orally at 5 mg, twice a day, mirtazapine orally at 15 mg, once a day (one at night) for sleep, levothyroxine orally at 150 ug, once a day for thyroid, metoprolol orally at 25 mg, twice a day, fenofibrate orally at 150 mg, once a day, benazepril orally at 10 mg, once a day for blood pressure. Consumer stated, "patient was taking these from years and she would take them for rest of her life." The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) on 16Feb2021 (at the age of 88-year-old) as a single dose in right shoulder for COVID-19 immunization. It was reported that, caller states that she was transferred from reporting her side effects after receiving the second dose of the Pfizer COVID-19 vaccine. She was not sure if it was someone in DSU, however, she states, "they took all of her information." The caller was an 88-year-old female who received the second dose of the Pfizer COVID-19 vaccine on Thursday 11Mar2021 and then the next day (12Mar2021) she states, "patient thought she had the COVID, she had flu like symptoms, and throwing up, she was so sick but now (on an unspecified date in 2021) she was just stuck with chills, hot flashes and night sweats. Today patient have not had any chills but mostly just the hot flashes. Patient don't think she have a fever. Patient went to the Ear Nose and Throat doctor yesterday for her ears and she did not have a fever there and the doctor told her he does not know anything about chills. Caller wants to know what she take to help these symptoms. Consumer stated, "patient tried calling last night but she waited for 2 hours and she felt asleep. Patient had her COVID second shot last Friday she have been sick since. Patient have the chills off and on in the day and at night she perspire the whole night. Patient have never felt this before it was crazy. Enquired was that from the COVID vaccine or not. Could she ask you a question. Do other people have chills and sweating or not. Was that one of the problem or side effect of vaccine." Consumer was informed about Pfizer Medical information department. When probed if still experiencing the events, Consumer stated, "no she was only experiencing chills and sweating on an unspecified date in 2021, and she never sweat it was something new for her. It was persisting at least 3 times a day she have chills and at night it hits her. Enquired was there something she could take or not. Patient tried Tylenol, she tried Norco it doesn't work." Consumer stated, "when she got her last shot which was on the 12th and she got sick, and it was horrible. Patient threw up, she had stomach problems on an unspecified date in 2021. Patient was chilling, she was sick. Patient thought she had the COVID, she hurt all over on an unspecified date in 2021. Chills and sweating. Patient thought she have got the COVID." Consumer stated, "no she was only experiencing chills, sweating and she never sweat it was something new for her. Its persisting at least 3 times a day she have chills and at night it hits her. Enquired was there something she could take. Patient tried Tylenol, she tried generic Norco it doesn't work." Received call from consumer regarding the Pfizer COVID vaccine. She was very ill. She thought she had the COVID. There was no prescriber. She spoke with someone else and was completing report and got disconnected. She does not have a report reference number. He got the medications and was going to speak with someone about a nurse where she could get questions answered. She was having hot flashes really bad and wants to ask someone what she can do to help with that. At the end he told her he would give her a number to call to talk to a nurse about symptoms and what she could do about it. She was having hot flashes really bad and wants to ask someone what she could do to help with that. Caller received second dose of vaccine and felt "deathly sick" afterwards. Has been experiencing "hot spells and chills". Consumer stated, "patient got an X-ray on Wednesday (on an unspecified date in 2021) as she fell and tore two ligaments in her hand." Consumer stated, "she took Tylenol and generic Norco. Patient took generic Norco 10/325 this morning. Patient don't take Tylenol and generic Norco together." The patient underwent lab tests and procedures which included weight: 88.9 kg on an unspecified date, X-ray: Unknown results on an unspecified date in 2021. The outcome of the events chills, sweating was not recovered and unknown for the other events. Description of Product Complaint: Consumer stated, "patient tried calling last night but she waited for 2 hours and she felt asleep. Patient had her COVID Second shot last Friday she have been sick since. Patient have the chills off and on in the day and at night she perspire the whole night. Patient have never felt this before it was crazy. Enquired was that from the COVID vaccine or not. Could she ask you a question or not. Do other people have chills and sweating. Enquired was that one of the problem or side effect of vaccine."
88 2021-05-05 weakness weakness loss of appetite continue fluids, continue soft diet, chicken soup Tylenol extra strength ... Read more
weakness loss of appetite continue fluids, continue soft diet, chicken soup Tylenol extra strength for aches and pains and fever
88 2021-05-06 pain in extremity Feb 17 - second pfizer shot. Shortly after second dose, was instructed to stop warfarin (for h/o VTE... Read more
Feb 17 - second pfizer shot. Shortly after second dose, was instructed to stop warfarin (for h/o VTE, pt with IVC filter) March 3rd - ultrasound of legs both clear ~April 27th - c/o leg pain May 6 - admitted to hospital with DVT, PE
88 2021-05-12 facial pain Patient daughter in-law stated that patient started having Facial swelling that started on 05/11/202... Read more
Patient daughter in-law stated that patient started having Facial swelling that started on 05/11/2021 on one side and later in the day patient had facial swelling to her entire face. Patient was seen by her PCP and prescribed Cephalexin 250mg TID time 7 days, steroid injection, and follow-up with PCP on 05/12/2021 with complaint of sore throat and facial pain. Prescribed Prednisone injection and Valacyclovir. Reporter asked if patient was diagnosed with Shingles and daughter in-law stated that the doctor mentioned that diagnoses but was not sure that it was Shingles.
88 2021-05-17 numbness 2 months later, headache, body aches, dizziness, sinus blockage and significant loss of hearing in o... Read more
2 months later, headache, body aches, dizziness, sinus blockage and significant loss of hearing in one ear. Facial numbness on one side.
88 2021-05-18 weakness ED to Hosp-Admission Discharged 3/28/2021 - 3/30/2021 (2 days) Last attending ? Treatment team W... Read more
ED to Hosp-Admission Discharged 3/28/2021 - 3/30/2021 (2 days) Last attending ? Treatment team Weakness Principal problem Discharge Summary DO (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Date: 3/30/2021 Admission Date: 3/28/2021 Length of Stay: 2 Days Discharge Date: 3/30/2021 Admission Diagnosis Hospital Problems POA * (Principal) Weakness Yes Hypothyroidism Yes Pure hypercholesterolemia Yes Benign essential hypertension Yes Atrial fibrillation Yes Acute cystitis without hematuria Yes Generalized weakness Yes COVID-19 virus infection Yes Chronic respiratory failure with hypoxia Yes Home Under Care of a company unnamed CODE STATUS: Full Code Active Issues Requiring Follow-up Finish course of antibiotics. Participating remote monitoring. Test Results Pending at Discharge Pending Labs Order Current Status Blood culture Preliminary result Blood culture Preliminary result Hospital Course HPI: Patient is a 89 y.o. female with PMH listed who presents from home with her daughter complaining of about a week of increased weakness/fatigue and cough. The fatigue is their primary concern, as this is so profound she will fall asleep on the toilet or even in the middle of getting dressed. Appetite is decreased, but she denies N/V/D. She feels "chilled", but no known fevers, no rigors/sweats. Cough is occasionally productive of sputum, mostly clear but sometimes with small "chunks"; no hemoptysis. No LE edema. No HA or changes in taste/smell. No known sick contacts, but patient has exposure to multiple daughters who help care for her, and she has been attending church recently. Urine is dark/strong, but she denies dysuria. Pt has received both doses of COVID-19 vaccine, second dose on 3/17/21. Hospital Course: Patient was admitted to medical floor for COVID-19 infection and urinary tract infection. Patient had a very mild course of illness. Decadron was started but patient did not require any remdesivir. Patient has remained at her seen home oxygen requirement. Patient was seen by PT and OT services for generalized weakness. Blood cultures have been negative. Patient is medically stable for discharge home today. She will need another 2 days of antibiotics treatment for urinary tract infection. Since her respiratory status has been very stable, we have chosen to discontinue the use of Decadron upon discharge to avoid any changes in mental status induced by steroids in an elderly patient. Home health services and remote monitoring kit have been ordered at the time of discharge. I have called patient's daughter to provide update that patient is coming home today and answered her questions
88 2021-05-18 brain damage ED to Hosp-Admission: Discharged 4/9/2021 - 4/12/2021 (3 days) Admission Date: 4/9/2021 - Discharge ... Read more
ED to Hosp-Admission: Discharged 4/9/2021 - 4/12/2021 (3 days) Admission Date: 4/9/2021 - Discharge Date: 4/12/2021- Presenting Problem/History of Present Illness/Reason for Admission- Intracranial mass [R90.0], Hyperglycemia [R73.9], Acute encephalopathy [G93.40], COVID-19 [U07.1]. COVID-19 infection: Despite patient's immunization history, patient did test positive for COVID-19 on presentation. She required supplementation with 2 L of oxygen to maintain oxygen saturations. Dexamethasone 6 mg daily and remdesivir were initiated and continued for four days. Patient did have mild sinus bradycardia (with heart rates in the 50s) towards the end of the hospitalization but remained asymptomatic. Oxygen was weaned to room air and patient remained stable for
88 2021-06-03 weakness low grade fever; some headache/Some headaches; Extreme fatigue/ exhausted and tired; Very weak; This... Read more
low grade fever; some headache/Some headaches; Extreme fatigue/ exhausted and tired; Very weak; This is a spontaneous report from a contactable consumer(patient herself) reported that a 88 years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6198 and expiration date: unknown), via an unspecified route of administration in left arm on 01Mar2021 at 10:45 AM as a single dose for COVID-19 immunisation. The patients medical history included asthma, sleep apnea, hypertension, bilateral hearing loss and exudative AMD, hashimotos, anaemia, aortic atherosclerosis, colonic diverticulosis, amplatzer atrial septal closure device and has got Covid-19 prior vaccination. The patient had a history of known allergies which includes severe reaction to penicillin. Concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6201 and expiration date: unknown), via an unspecified route of administration in right arm on 09Feb2021 at 10:45 AM as single dose for COVID-19 immunisation. The patient received no other vaccines in four weeks and has not been tested for Covid-19 post vaccination. The patient reported that there was no problem at all after am injection for next 13 hours. Then low-grade fever, some headache and EXTREME fatigue. Fell asleep about midnight and woke up 2pm next day (3rd). Very weak and exhausted and tired until about Friday the 5th. Some headaches and low-grade fever. Had no rest most days. No household chores possible. No treatment was received for adverse events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.
88 2021-06-09 weakness she almost passed out however she was able to grab unto the bed; bowel movement with quite a bit of ... Read more
she almost passed out however she was able to grab unto the bed; bowel movement with quite a bit of blood; Is having difficulty breathing; Slight temperature; Wakes up in morning with sweat; Food just doesn't taste right; Has been drinking a lot of water because she wants water; Mouth is so dry; Walking is much worse, has to hold onto everything; Weak; Not eating like she used to, eating the minimum to survive; Coughing and bringing up phlegm; Gets chills once in a while; Sleeping an awful lot; Coughing and bringing up phlegm; she had pressure in her heart; pain as aches and pain; Flu-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp. An 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201; Expiration Date: 30Jun2021),via an unspecified route of administration, administered in Left Arm on 19Feb2021 in between 2:15-2:30 as 1st Dose,0.3mL, Single Dose for COVID-19 immunization. The patient's medical history included diabetes mellitus, blood pressure abnormal(High blood pressure), hospitalized prior to the COVID Vaccine. It was two years ago and she was hospitalized for COPD. Three years ago she went to visit her sister in and wound up with the Flu and Pneumonia where she almost died. She was still here. Cardiac disorder, atrioventricular block, heart problems for several years, Had a blockage, blood glucose abnormal, Had the Flu and that was how she felt. When she had a hard time breathing she did not know if it was the flu or pneumonia. So much stuff was put in her. Needles were being plunged in her. She did not know what she was given. It was a really rough time. Patient also broke her finger in Dec2020. Infection set in after her finger was set with a metal plate. The metal plate dug into her finger and created an infection. She was in excruciating pain. The metal plate was taken off and has been told she will have a mullet finger. Stated kids get it from sports and is where the finger just hands. The finger doctor told her there was nothing that can be done because the bone has disintegrated into her body. Concomitant medications included insulin glargine (LANTUS)Product strength and count size dispensed: 100 units ml 3mg prefilled pen, was originally taking Lantus, 20 at night, but it wasn't doing the job. Dose was split to 15 in the morning and 15 at night, NDC: 0088-2219-01,Lot: OF7051A,Exp: 2023 ; Insulin (HUMALOG) NDC: 0002-8799-01 ,Lot: Unknown, Expiry:Jun2022,Had to get into light to read Humalog. Didn't see lot number, taken for blood glucose abnormal. Doesn't take that often. Only takes if blood sugar is over 150. No History of all previous immunizations with Pfizer vaccine considered suspect were provided. With regards to prior vaccination within 4 weeks, stated she fell and hit her head and had to get four staples in Dec2020. She was given a vaccine for tetanus and diphtheria and stated maybe a slight rash or achy, a little red, but never any other reaction. No Additional vaccines administered on same date of Pfizer suspect. Did not require a visit for AES. The patient received the 1st dose of the Pfizer covid vaccine on 19Feb2021, scheduled for her 2nd dose on 12Mar2021. She says this was the 5th day of her having flu-like symptoms, which she previously reported. This morning she had pressure in her heart for which she took Nitro. As she was trying to get to the bathroom, she almost passed out however she was able to grab unto the bed and did not fall. She then went to the bathroom and had a bowel movement with quite a bit of blood. She does report a history of heart problems for several years. Had a blockage. Had one COVID Vaccine and now has all kind of Flu like symptoms. Had a slight temperature. Wakes up in the morning with sweat, pain, and food just didn't taste right. Had Flu before and was having a lot of Flu like symptoms. Was having difficulty breathing and coughing. Also had COPD. Wanted water and had been drinking a lot of water. Her mouth wa so dry. Stated she was sort of used to the difficulty of breathing. Had been in the hospital for COPD. Stated her walking wasn't that great to begin with, but now was much worse. She had to hold onto everything. was not eating like she used to, only the minimum to survive. She was weak. Had been having difficulty breathing a lot before the COVID Vaccine. Didn't know if she COVID Vaccine just got it started a little more. Was constantly blowing her nose and bringing up a lot of phlegm, but she knew that was from her COPD. Got the chills once in a while. Was freezing and then warm. Has been sleeping an awful lot. The patient underwent lab tests and procedures which included body temperature: 99.4 slight, glycosylated haemoglobin:10.Wanted to finally go out a little bit and walk around. Had been in the apartment for so long. Went back for second COVID Vaccine on 12Mar2021. Wanted to get back into the swing of things. Therapeutic measures were taken as a result of, she had pressure in her heart (cardiac discomfort). The outcome for the events was Unknown.
88 2021-06-10 weakness Patient got her vaccine then the next day developed weakness and knee pain. Later the daughter admi... Read more
Patient got her vaccine then the next day developed weakness and knee pain. Later the daughter admitted that she had had increased weaknesss and confusion for a few weeks. She was seen in her PCP's office and diagnosed with a UTI and gout. The x-ray of her knee later showed a fracture of her proximal tibia. A few days later she was brought to the emergency department with a wide complex tachycardia and acute coronary syndrome. She had an 11 day stay complicated with congestive heart failure, hypoxia, aspiration pneumonia and metabolic encpehalopathy. Her daughter thinks that this was brought on by the vaccine, and asked us to fill out a vaers.
88 2021-06-10 hot flush the symptom extended to chest area.; flushed, hot hands, forearms and also chest.; a very slight pin... Read more
the symptom extended to chest area.; flushed, hot hands, forearms and also chest.; a very slight pinkish tone to the affected skin.; This is a spontaneous report from a non-contactable pharmacist. A 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 05Mar2021 (Batch/Lot Number: EN6202) as 1st DOSE, SINGLE for covid-19 immunisation; Age at vaccination:88 years.The patient medical history was not reported. The patient's concomitant medications includes: sertraline hcl (SERTRALINE HCL), via an unspecified route of administration from 05Mar2021 (Batch/Lot number was not reported) to an unspecified date, at 50 mg for an unspecified indication . Facility type vaccine: Hospital. The patient previously took morphine and experienced drug hypersensitivity. The patient experienced flushed, hot hands, forearms and also chest (non-serious) on 09Mar2021, a very slight pinkish tone to the affected skin (non-serious) on 09Mar2021, the symptom extended to chest area. (condition aggravated) (non-serious) on 11Mar2021. The outcome of the events was recovered in Mar2021.The clinical course was reported as follows: Patient received Pfizer COVID-19 vaccine on 5Mar21, and on 9Mar2021 she started experiencing flushed, hot hands, forearms and also chest. She also had a very slight pinkish tone to the affected skin. It disappeared within 2 hrs but then returned in the AM. 11Mar the symptom extended to chest area. The patient also started Sertraline 50mg 5Mar21, same day as vaccine administration. They contacted PCP and she did not believe the rxn was due to the Sertraline. As of 15Mar21 the symptoms have subsided. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
88 2021-06-15 weakness Previously reported with Moderna as vaccination which is in-correct. Pt received Pfizer so am re-su... Read more
Previously reported with Moderna as vaccination which is in-correct. Pt received Pfizer so am re-submitting. reports severe headache, nausea and weakness, no fever. Saw MD on 6-14 or 6-11; says MD told her it was a reaction to vaccination.
88 2021-06-20 difficulty speaking 2 months after last dose, a routine bloodwork revealed high kidney numbers. Voice became hoarse and ... Read more
2 months after last dose, a routine bloodwork revealed high kidney numbers. Voice became hoarse and difficulty in swallowing ease was noted. Repeat blood work confirmed kidney numbers still high after hydration, IV fluids given at home. Fatigue increased and I took my mother to the ER. She was admitted and she spent 3 weeks in the hospital, 1 week in ICU. She was eventually diagnosed with the autoimmune disease ANCA Vasculitis. Biopsy confirmed. No previous kidney disease or abnormal blood work. She was treated with high dose steroids and chemotherapy. There was no positive response to treatment. Condition worsened and she was moved to Hospice care. My mother died on 05/16/2021
88 2021-06-30 burning sensation burning sensation in feet and legs; weakness in arms and legs; shortness of breath; feeling like a t... Read more
burning sensation in feet and legs; weakness in arms and legs; shortness of breath; feeling like a tight band is around feet; Lethargy; This is a spontaneous report from a contactable consumer (patient). A 88-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported) via an unspecified route of administration, administered in arm right on 31Jan2021 10:00 (at the age of 88years) as single for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included lisinopril , hydrochlorothiazide , diltiazem and omeprazole. No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination, no known allergies. On 04Feb2021 12:00, the patient experienced lethargy, weakness in arms and legs, shortness of breath, burning sensation in feet and legs, feeling like a tight band is around feet. No treatment was received for all events. The outcome for all events was not recovered. Follow-up attempts are completed. No further information is expected.
88 2021-07-02 speech disorder No affects from first shot. Second shot seemed ok until midnight when my wife fainted. She is on ... Read more
No affects from first shot. Second shot seemed ok until midnight when my wife fainted. She is on a blood thinner and it made the levels change and set off her A-fib . The next 3 days she had body pain. Her leg strength has weakened. It has been over a month and she is not back to the levels of health she had before the second shot. I also notice she rambles in conversation.
88 2021-07-07 weakness Dose 1 on 2/1/2021, dose 2 on 2/21/2021. Symptoms of cough, malaise/fatigue and weakness on 06/15/2... Read more
Dose 1 on 2/1/2021, dose 2 on 2/21/2021. Symptoms of cough, malaise/fatigue and weakness on 06/15/2021. Diabetes Type 2- not well controlled ON LONG TERM MAINTENACE TREATMENT FOR MELANOMA. Pneumonia possibly due to COVID-19. Patient had received 2 doses of Pfizer COVID vaccine in February of 2021. COVID positive test on 6/23 Exposed to daughter (vaccinated, symptom onset on 6/21/2021).
88 2021-07-08 feeling hot, weakness Fever chills; Weakness; Muscle soreness; Tiredness; Joint pain; Cough; Hurts to Breathe; Hives at In... Read more
Fever chills; Weakness; Muscle soreness; Tiredness; Joint pain; Cough; Hurts to Breathe; Hives at Injection Site/hives all over; Skin and Eyes Burning and Itching/her whole body is hot and itching; Couldn't Sleep; sweating and felt hot; Skin and Eyes Burning and Itching; sweating and felt hot; Sinuses and Nose Plugged Up; Diarrhea and Upset Stomach; Stomach Hurting; Diarrhea and Upset Stomach; Stomach Hurting; No Appetite; Sinuses and Nose Plugged Up; Diarrhea and Upset Stomach; Stomach Hurting; sickness; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 88-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:30 (Batch/Lot Number: EN6202) as dose 2, single for covid-19 immunisation (reason: giving them and because she had bone marrow disease and doctor thought she should get it) at doctor office. Medical history included 2 aortic valve replacements (last one was replaced 3 years ago in May and the first one was replaced 5 years ago), ongoing autoimmune disease and ongoing acid reflux, bone marrow disease and Covid. Concomitant medication(s) included prednisone (5mg once a day by mouth; she had been taking it for a number of years for a condition auto immune disease and she has to take it for the rest of her life) taken for autoimmune disorder, and pantoprazole (40mg once a day by mouth; started probably 5years ago) taken for acid reflux, start and stop date were not reported. The patient previously took BNT162B2 (Lot: EM9809) as dose 1, single on 12Feb2021 for covid-19 immunisation; flu vaccine for asthma (when she got a flu shot years ago, she had to go to ER for an asthma attack from that; it was way back in the 1990s; NDC, Lot, Expiration: Unknown). No investigation assessment was done. No vaccines administered on same date of the Pfizer suspect. No Prior Vaccinations (within 4 weeks). Family medical history relevant to adverse event was none. The patient experienced sickness on 05Mar2021; fever chills on an unspecified date, sinuses and nose plugged up; diarrhea and upset stomach; stomach hurting; no appetite on 08Mar2021; sweating and felt hot; and skin and eyes burning and itching/her whole body is hot and itching; and couldn't sleep on 12Mar2021; hives at injection site/hives all over on 14Mar2021, hurts to breathe on 15Mar2021; cough on 17Mar2021; tiredness; joint pain on 21Mar2021; muscle soreness on 22Mar2021, weakness on 23Mar2021. Therapeutic measures were taken as a result of this with BENADRYL, Z PACK, MYLANTA AND TYLENOL. Clinical course was as follow: The patient stated that she wondered if should've even had the vaccine. The patient had Covid in Mar2020 (a year ago in March) and she had long haulers until Jan2021. In March, her hematologist called and said she could get vaccine and stated that she shouldn't have. She stated that the second one made her really sick. This sickness was getting too long. Her second dose of the vaccine was on 05Mar2021. She was so tired; stated she doesn't feel good. She stated that she felt like she has long haulers all over again, it was horrible. Stated she felt like she shouldn't have gotten the second one. States she was doing okay with first one. Caller states that she already gave up a whole year of her life because of this. She tried to call before, but she didn't wait to talk to someone, she had to go somewhere. The patient stated that she had hives, tiredness, problems with her intestines, got really sick, her skin and eyes started to burn, she felt like she had hives all over, her skin was burning, she was sweating and felt hot, stated on the 14th it really got bad, her whole body was hot and itching. States that she took a BENADRYL and felt better the next 2 days and then started getting sinuses and nose plugged up and it hurt when she was breathing, had a slight fever, and her skin was itchy. She states that she went to doctor on 15Mar2021 (physician office visit), and he didn't think too much of it because her oxygen was okay. States that she felt worse, she was coughing bad, felt terrible, her muscles ache, and when she was hot, she couldn't sleep, now all she wanted to do was sleep and she had fever and chills. She was supposed to do exercises, but she couldn't, and it started two days ago. States she was not coughing as much but it was still hard and hurting. It was some of her joints, not all of her joints were hurting like when she had long haulers. Fever and chills started when her sinuses started acting up. The fever and chills kept getting occasional slips in and out. Her fever was not high but enough to get the chills. Sinuses and nose plugged up: it came and went with MUCINEX and it helped a little. Her intestinal problems were diarrhea that started on 08Mar2021 and upset stomach. She had a problem and it hurt terrible for days after. No appetite lasted for one week, so probably ended 15Mar2021. Caller states that she felt a little better but can't get rid of her cough. Couldn't Sleep: started when she had the burning and lasted a little after because she had to get herself together again. She could only sleep three hours at time. Skin and Eyes Burning and Itching: The burning and itching went away for a while, but it was back again because she had been lying in bed and tired, stated that it was not so bad. The burning stopped 15Mar2021 when the hives were gone, but she stated that right now it was back, her skin gets hot and then starts burning and itching. Patient stated that she did not have too much problems with first but this second, oh my god. She thought she got it too soon after having long haulers. She got rid of that in Jan2021 and was feeling good but now she felt terrible again. States there were no tests, she didn't have any. She was so weak, and she was having a hard time now, and she was doing so good. She was worried about her heart and valves. She guessed that call handler couldn't help her either, she stated that she didn't know what to do to feel better. She thought she had better call and report it. She has already gone to doctor and had only gone to him for 2 years, but hopefully he knew enough about her. She states that she probably should call him because she wasn't getting any better. The outcome for hives at injection site/hives all over was recovered on 15Mar2021, skin and eyes burning and itching/her whole body is hot and itching was not recovered, muscle soreness was not recovered, weakness was not recovered, cough was not recovered, tiredness was not recovered, joint pain was not recovered, fever chills was not recovered, sinuses and nose plugged up was unknown, diarrhea and upset stomach; stomach hurting was recovered on 11Mar2021, hurts to breathe was recovering , couldn't sleep was unknown, no appetite was recovered on 15Mar2021, sickness was unknown, sweating and felt hot was not recovered , sinuses and nose plugged up was unknown, skin and eyes burning and itching was not recovered, sweating and felt hot was not recovered. No follow-up attempts are possible. No further information is expected.
88 2021-07-28 weakness Major, life-debilitating stroke.
89 2021-01-03 weakness Swelling of eyes, lip numbness, tingling and dryness. Dizzy and weak. Client received Benadryl and w... Read more
Swelling of eyes, lip numbness, tingling and dryness. Dizzy and weak. Client received Benadryl and was transported to hospital via EMS.
89 2021-01-07 tremor APPROXIMATELY 1 HOUR POST VACCINATION, DEVELOPED DIZZINESS AND SHAKINESS THAT LASTED FOR AN HOUR BEF... Read more
APPROXIMATELY 1 HOUR POST VACCINATION, DEVELOPED DIZZINESS AND SHAKINESS THAT LASTED FOR AN HOUR BEFORE RESOLVING.
89 2021-01-12 weakness Resident received 1st dose on 1/4/2021. On 1/6/2021 resident having SOB, increased weakness with O2 ... Read more
Resident received 1st dose on 1/4/2021. On 1/6/2021 resident having SOB, increased weakness with O2 sats at 91% RA. On 8th resident sustained a fall, O2 sats 88-92, dizzy, weakness. Rapid COVID test performed with negative results. Evening of 8th resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the ER on 1/9/2021 with new diagnosis of Leukemia and orders for hospice. Continued with fever, crackles and N/V and loss of appetite from the 9th and 10th of January. Resident expired at 820am on 1/11/2021.
89 2021-01-12 grand mal seizure The nursing home resident received the vaccine at 11:00 am. At 11:45 am she had an episode of non-bl... Read more
The nursing home resident received the vaccine at 11:00 am. At 11:45 am she had an episode of non-bloody, non-bilious vomiting. At 12:00 pm she had an episode of loose stool. At 12:15 pm she was noted with generalized tonic-clonic seizure-like activity. Oxygen was applied via non-rebreather mask and resident was transferred to the Hospital Emergency Department for further evaluation. At the time of this report, she is stable in the ED and awaiting imaging studies. (head CT)
89 2021-01-17 weakness Lack of Energy and Poor appetite
89 2021-01-18 facial paralysis Patient developed left sided facial droop and left eye droop/paralysis on 1/17/21. No medical treatm... Read more
Patient developed left sided facial droop and left eye droop/paralysis on 1/17/21. No medical treatment was necessary. Hospice and family were notified. Symptoms continued on 1/19/21 and the nurse practitioner ordered Refresh tears to left eye three times a day x 14 days, tape eye shut at night as tolerated and start Prednisone 40mg orally x 4 days then 20mg orally x 3 days.
89 2021-01-18 grand mal seizure Emesis, LBM, Grand Mal seizure activity
89 2021-01-18 tremor Systemic: TINGLING SENSATION ON TONGUE, SHAKINESS. PATIENT ASKED FOR BENADRYL FROM FACILITY AND WAS ... Read more
Systemic: TINGLING SENSATION ON TONGUE, SHAKINESS. PATIENT ASKED FOR BENADRYL FROM FACILITY AND WAS FINE . COUNSELED ON FALL RISK BUT SHE SAID SHE DOES FINE WITH BENADRYL AND ASKED FOR IT AND WAS COUNSELED AND
89 2021-01-19 tremor 3 days post = tremors; 4 days post= pneumonia; 6 days post= hospitalized
89 2021-01-20 pain in extremity arm and hand swollen nd very painful.
89 2021-01-21 weakness DEVELOPED NAUSEA WITHOUT VOMITING AROUND 0300 ON 1/19/21. WEAKNESS, LETHARGY, FATIGUE, AND REPORTS G... Read more
DEVELOPED NAUSEA WITHOUT VOMITING AROUND 0300 ON 1/19/21. WEAKNESS, LETHARGY, FATIGUE, AND REPORTS GENERALIZED BODY ACHES. HYPERTENSIVE AND TACHYCARDIC. WAS SENT TO PCP FOR EVALUATION. SYMPTOMS RESOLVED.
89 2021-01-21 speech disorder, tingling, mild one side paralysis Pt got second dose of Pfizer after unremarkable first dose. 2 hours later at home developed garbled ... Read more
Pt got second dose of Pfizer after unremarkable first dose. 2 hours later at home developed garbled speech and confusion. Taken to ED and evaluated for acute stroke, TPA given. CT was not definitive. Weakness was R>L. Pt confusion worsened a bit into evening of day of event, but by the following morning pt had returned to baseline. Is an independent 89 yo who otherwise lives at home alone and is highly functioning. Pt did have a recent kyphoploasty and SI joint injection (perhaps with steroids/lidocaine). Currently patient hospitalized, expected discharge soon, only complaint is tingling in fingers.... we believe this may have been coincidental, but due to time course are reporting here.
89 2021-01-24 unresponsive to stimuli SON SAID PATIENT WAS FOUND UNRESPONSIVE AND CALLED 911
89 2021-01-27 speech disorder The next morning after receiving the vaccine I noticed that my mother she talking to me, as her prim... Read more
The next morning after receiving the vaccine I noticed that my mother she talking to me, as her primary giver she knows me and comfortable to me. She tells me the same story over the over with isn't abnormal. It was every 3-4 words she was jumbling her words. I didn't think anything of it at first. I just let it go. Early Wednesday morning 2:48am, I heard her in her bedroom. I went to check on her, I found at her dresser trying to put her watch on. She didn't know who was I or didn't know where she was. It took me about 40 minutes to calm her down. Now it was every 2 words that she was jumbling up. I finally got her back to bed. I went to send a message to her doctor. In the morning someone from the doctor's office called back I explained what was going on and they said get her to an ER. I took her to the hospital 01/27/2021. She was admitted to hospital for overnight observation. Still not been discharged. Patient was still confused when I had to left last night, did not understand where she was at or why she had to stay there. My mother was very angry when she woke up early Wednesday is not my mom she is very lovely. One year or two years she did have a TA or mini stroke.
89 2021-01-27 unresponsive to stimuli Patient recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic #1. Patient tested positive fo... Read more
Patient recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic #1. Patient tested positive for COVID-19 by rapid testing on 1/6/21. She demonstrated poor appetite and fluid/food intake and an IV of Normal Saline was initiated on 1/7/21. Oxygen saturation was initiated on 1/12/21 at 4L per nasal cannula. for shortness of breath. On 1/22/21 at 0310 Patient was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated.
89 2021-01-28 pain in extremity arm is hurting so bad; could not move her arm, her left arm; it feels like lead; she got the injecti... Read more
arm is hurting so bad; could not move her arm, her left arm; it feels like lead; she got the injection in is like equalizing the pain she has; hurts all over; sleeps every 2 hours; This is a spontaneous report from a contactable consumer (patient). An 89-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date), via an unspecified route of administration on the left arm on 13Jan2021 10:35 at a single dose for COVID-19 immunization. Ongoing medical history heart failure, kidney failure, scoliosis and strained hernia (causing pain down her right leg). Other medical history includes patient gave up her car and as a result she went from 5ft 4 inches to 5ft 1 inch and went from 150 pounds to 106 pounds (stated she loves this new weight. She looks fabulous and wonderful in clothes). The patient's concomitant medications were not reported. It was reported that the patient was a retired school teacher, called about the shot, the vaccine, clarified as the COVID Vaccine. She mentioned she has a history of heart failure, kidney failure, scoliosis, and hernias. She was concerned about getting the vaccine and did not think she should get it, but her doctor informed her she should get it so she did. Since getting it she is having a hard time. Stated it feels like lead. She contacted her doctor and was informed to wait it out 24 hours and it would be a lot better. It was reported that the patient got the COVID Vaccine shot yesterday (13Jan2021 10:35). She mentioned her arm is hurting so bad. She contacted her doctor's office and was informed to give it another 24 hours for the pain to go away. It was reported that the patient hurts so bad, she hurts all over. She added she guesses the arm where she got the injection in is like equalizing the pain she has. She stated as soon as she got the injection everything was wonderful. It was afterwards she felt like she could not move her arm, her left arm. She felt like at first she was having a stroke. She did some self testing and was happy she realized she was not having a stroke. It was reported that the patient provided conflicting details of when arm hurting started. She initially stated it started 13Jan2021. She then stated she did not feel it until 8am in the morning of 14Jan2021 (pending clarification) when she could not move her arm and thought she was having a stroke. She commented she sleeps every 2 hours. She would later mention in report she felt the arm pain starting yesterday (as reported). Attempts made to clarify start of arm hurting, but unable to clarify further. She is scheduled to get the second does on 03Feb2021. She commented even with her age she is still very useful. She was told to continue taking acetaminophen. She has the 1000 mg, take two pills every six hours. She was told if she continued to have pain to take Aleve. Treatment was given for the events. The outcome of the event was unknown. Information on the lot/ batch number has been requested.
89 2021-01-29 weakness, unresponsive to stimuli Resident per her usual health when dietary staff were into apartment at 0730 with her breakfast. Res... Read more
Resident per her usual health when dietary staff were into apartment at 0730 with her breakfast. Resident conversing, appropriate, with no focal deficits with ADL. Resident baseline with mild confusion, generalized weakness, using a 4 wheeled walker when ambulating. Med care manager into room at 0830 with am medications. Resident was lying partially on her bed, non responsive. EMS was called immediately and resident was transported to Hospital ER. Wellness nurse was notified later that resident was admitted for rule out CVA.
89 2021-01-29 weakness Flu like symptoms, fever, fatigue, chills, weakness, achy muscles. Difficulty breathing.
89 2021-01-31 hot flush My blood pressure has always been normal. On the Saturday following my shot on Wed. my blood pressur... Read more
My blood pressure has always been normal. On the Saturday following my shot on Wed. my blood pressure went to 157 over 125 . Felt terrible like (when you bend over and get up to quick) that feeling stayed constant also a feeling of a constant hot flash. Doctors at ER gave me a through checkup and everything checked out normal except blood pressure. They said be sure and notify you because they think it probably was the vaccination. I am making an appointment with my doctor today .
89 2021-02-03 feeling cold Confused; Disorientated; Sleeping a lot/Groggy; Headache; Felt very weak, felt very tired; felt very... Read more
Confused; Disorientated; Sleeping a lot/Groggy; Headache; Felt very weak, felt very tired; felt very panicky; Dizziness; Felt like she had the flu; Chills; pain in her neck; she was cold; This is a spontaneous report from a contactable consumer (patient). This 89-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number PFREL1283, Expiration Date 30Apr2021), via intramuscular, on 15Jan2021 (at 12:00) at a single dose on the left arm for COVID-19 immunisation. Relevant medical history included ongoing lymphoedema (she gets water in her legs), ongoing severe arthritis of both knee caps (she had a cortisone shot and lidocaine in her knees), and dust allergy. Historical vaccine included flu vaccine received in Jan2020 and in Oct2020 (with terrible reaction: pain in arm, numb in arm and muscle pain arm for 6 weeks). Past drug history included allergy to lidocaine (her face swelled up), and hydrocortisone (CORTISONE). She was in a wheelchair. Surgical history included 2 hip replacements. Relevant concomitant medications included drug for lymphoedema. The patient stated she started having side effects almost immediately after receiving the COVID-19 vaccine. She felt very panicky, felt very weak, felt very tired. She had like a headache. Some of the symptoms started the day she got the shot and then more symptoms arose the day after. She was very tired and was sleeping a lot the next day. She felt very like groggy. In fact, she was so groggy, she pressed the wrong button in her chair. She clarified she has lymphedema and she has to be in a lift chair to keep her legs elevated. When she needs to get up, she presses a certain button to raise and lift the chair into a sitting position. However, that day, her doorbell rang (her meals are delivered to her) and she was so groggy and confused, that she pressed the button that put her straight out into a lying position instead of a sitting position. She ended up sliding off the chair and onto the floor. She had to call for assistance (there is an emergency button she can press). She had to be lifted off the floor. She explained to them she didn't end up on the floor from walking, she slid off the chair. She was so disoriented she pressed the wrong button. She felt like she had the flu, she was cold, she had the chills. She was laying down, covered up with 2 blankets. She couldn't move. It was terrible. At the time, she slid off the chair, she had to go the bathroom. She is on a water pill which makes things worse, but she has a bedside commode close to her lift chair. When she was trying to get off the chair go to the bathroom (which is only 4 or 5 steps away from the commode), she was so disoriented, she pressed the wrong button. She has had this chair for 5 years. She slid off the chair and ended up hitting the floor with her rear end. She remained on the nice cold floor (its a ceramic tile floor) until they came to pick her up. She mentioned she has had 2 hip replacements and once she is on the floor, she can't get up. Once assistance from where she lives came to pick her up, she was asked if she need to go the hospital or call ambulance. She explained to them she didn't fall. She slid off the chair. She is a very active person. Although she is almost 90, year is not senile. She slid off the chair, she didn't fall. The patient stated that she got the flu shot this past October and had a terrible reaction to that, too. Therefore, she doesn't know if it's just her system. She has had a flu shot every single year for the past 10-15 years and she has never had a reaction at all. She received the regular flu shot at her doctor's office in Oct2020 had a terrible reaction, she had severe pain in her arm where they gave her the shot, the pain wasn't at the injection site, the shot was high up the arm, her arm was numb and she couldn't raise it; she had muscle problems with the arm, she had trouble with her arm for 6 weeks. She has been taking naproxen sodium (ALEVE) for the headache. She has just been treating it symptomatically. No fever and she has just felt cold. The patient stated she really is not sick. She went to pick up dog medicine from the vet and when she leaves her facility, her temperature is always checked when she comes back. She was told her temperature was 97 something. So, she wasn't running any temperature prior to the vaccine. The patient was planned for the second dose on 05Feb2021. The patient stated her symptoms are not so severe it affects her breathing or something serious. It's just a pain in her neck to walk around with a headache. The outcome of the events was unknown.
89 2021-02-08 unresponsive to stimuli Patient remained in the monitoring room for an hour after her vaccine. She had no adverse events for... Read more
Patient remained in the monitoring room for an hour after her vaccine. She had no adverse events for the first 15 minutes, but staff found her responsive only to sternal rub, slumped in her chair 1 hour after vaccine.
89 2021-02-10 feeling hot At approx. 11:42, pt. reported "burning on inside." Pt. was taken to first aid area of clinic. Pt. d... Read more
At approx. 11:42, pt. reported "burning on inside." Pt. was taken to first aid area of clinic. Pt. denies any rash, puritis, difficulty breathing, or throat irritation. V/S @ 1148: 97.9, 80, 180/95. Pt. started to report worsening of symptoms ("burning on the inside.") Benadryl 25mg PO administered per standing order at 11:52. Additional Benadryl 25mg PO given per standard order @ 1202. Nursing staff continued to monitor patient and @ approx. 1207, pt. developed shortness of breath and throat tightening. Epi 0.3mg IM administered per MD order at 1208. Pt. started to show improvement of symptoms at approx. 1210. Pt. reported that throat tightening was subsiding. EMS contacted. BP: 193/107 @ 1213, 181/95 @ 1219. Paramedics arrived at 1223 and patient transported. Daughter followed.
89 2021-02-14 numbness, tingling Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial are... Read more
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
89 2021-02-14 nerve pain, pain in extremity I suffer from neuropathic pain in both my feet at night in bed. It is alleviated by Voltaren or Ic... Read more
I suffer from neuropathic pain in both my feet at night in bed. It is alleviated by Voltaren or Icy Hot spray. This exaggerated pain in my feet had me up the entire night and nothing relieved it. I had to walk around and try to ease the pain but nothing gave me any relief. At 6am I took 2 1/2 gr of Valium and finally fell asleep for 3 hours. I was much better in the morning.
89 2021-02-17 slurring Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Syst... Read more
Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Medium, Systemic: SLURRED SPEECH, INABILITY TO HOLD SELF UP IN CHAIR, INCONTINENCE-Medium, Additional Details: RN ADVISED PT HAD FEVER OF 101, DIARRHEA, WHOLE-BODY MUSCLE SORENESS, STROKE LIKE SYMPTOMS INCLUDING SLURRED SPEECH, INABILITY TO HOLD SELF UP WHILE SITTING IN A CHAIR, INCONTINENCE, AND CONFUSION ABOUT HER SURROUNDINGS, DATE, TIME, AND SITUATION. ALSO ADVISED THAT PT IS A GREAT HISTORIAN & NORMALLY KNOWS CURRENT DATE, TIME, AND SITUATION. SYMPTOMS LASTED ROUGHLY 72 HOURS, AND PATIENT DID COMPLETELY RETURN TO BASELINE AFTER 72 HOURS HAD PASSED
89 2021-02-21 pain in extremity One week post vaccination, on 2/15, patient began to have soreness in arm, extending from elbow to s... Read more
One week post vaccination, on 2/15, patient began to have soreness in arm, extending from elbow to shoulder. On 2/17, the pain became more severe. On 2/18, the soreness seemed to be improving but not completely resolved.
89 2021-02-24 cold sweat Apparent vasovagal syndrome, came on suddenly, unable to walk, somehow was able to call son who came... Read more
Apparent vasovagal syndrome, came on suddenly, unable to walk, somehow was able to call son who came right over. I fell on floor, unable to get up. He called 911 and the firemen helped me sit up. I was cold and clammy, but could talk and answer all questions. The firemen said I should be all right and they left. They said they had had extra calls for the same symptoms. I went to bed, and my blood pressure was 93/53. I slept all right. The next day, yesterday, I was tired but feeling all right with the highest temp of 98.4. Today, February 25, I am doing better. I called and left a message for Dr.
89 2021-02-25 pain in extremity right arm is sore; Fever; tired; This is a spontaneous report from a contactable Nurse (patient). A... Read more
right arm is sore; Fever; tired; This is a spontaneous report from a contactable Nurse (patient). An 89-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/lot # EM9809, Exp date 30Jun2021) intramuscular at single dose in right upper arm on 11Feb2021 16:24 for Covid-19 immunisation, administered at hospital. Medical history included ongoing chronic obstructive pulmonary disease (COPD) and ongoing arthritis both diagnosed about 5 or 6 years before, covid-19 and pneumonia in Nov2020 and she was in the hospital from 04Nov2020 to 09Nov2020, she was hard of hearing. There were no concomitant medications. The patient received no prior vaccinations (within 4 weeks), aside the 1st dose of bnt162b2 (BNT162B2, Lot: EL9261, Exp date 31May2021) intramuscular at single dose in right upper arm on 21Jan2021 16:24 for Covid-19 immunisation. No additional vaccines administered on same date of BNT162B2. No events occurred following prior vaccinations. The patient experienced right arm is sore, fever, tired on 12Feb2021. The events were considered medically significant. No event required a visit to Emergency Room or physician. No relevant test done. Course of events as follows: Her arm was sore. Sore arm started on 12Feb2021 morning. She has arthritis and stated maybe this had something to with the soreness in upper right arm, near shoulder, where the vaccine was administered about an inch below her shoulder. Soreness was just there, it hurt. She was very tired and running a temperature of 100.4. She noticed the fever when she got up on 12Feb2021 morning, it was only 99.3 or 99 something, in afternoon it was 100.4. She did not like the fever. She took of paracetamol (TYLENOL 500mg, Lot: 9HV1619, Expiration date May2021) 1000mg twice and it did not really take her fever down. The outcome of events was not recovered. The reporter considered there was a reasonable possibility that the events right arm is sore, fever, tired were related to the BNT162B2.; Sender's Comments: Based on information available, a acausal relationship between events right arm is sore, fever and tiredness and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
89 2021-02-28 involuntary muscle movements Loose the control on the body, Head spinning because of this can't seat or stand without help not ab... Read more
Loose the control on the body, Head spinning because of this can't seat or stand without help not able to walk or get up from the bed.
89 2021-03-01 feeling hot Shrunk a little bit; really hot; Shivering; Tiredness; Fever; This is a spontaneous report from a co... Read more
Shrunk a little bit; really hot; Shivering; Tiredness; Fever; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the left arm on 04Feb2021 at 89-year-old at a single dose for COVID-19 immunization. Medical history included macular degeneration from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249; left arm) for COVID-19 immunization on an unknown date. The patient experienced the following events and outcomes: shivering (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021, tiredness (non-serious) on 10Feb2021 with outcome of not recovered, fever (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021, shrunk a little bit (non-serious) on an unspecified date with outcome of unknown, really hot (non-serious) on 10Feb2021 with outcome of recovered on 11Feb2021. The patient underwent lab tests and procedures which included body temperature: highest her temperature got was 100 on an unspecified date. About six days after the patient had her second COVID shot, the patient experienced shivering and tiredness. It was reported that the patient had shrunk a little bit starting on an unspecified date. At the time of the report, over the last 3 days, the patient experienced the side effects. "It could be from something else. She could have gotten something. She did not know." The patient also had a fever a few times. The patient would go between shivering and really hot so she would take her temperature. The patient did not normally have a fever. When the shivering came on, she was trying to cook, and could not hold the spoon in her hand. The patient did not know what was wrong, but she was cold. All she wanted to do was sleep. The only symptom she still had was being tired. The night before the report, the patient woke up so warm and was sweating; her pajamas were damp. The patient could not sleep in them, so she had to go change. The patient has not shivered since then. The tiredness was persisting. The patient slept on and off all day today, but she was feeling better in general. The patient took her temperature every day. "The highest her temperature got was 100."
89 2021-03-04 speech disorder, pain in extremity Patients arm started to hurt in afternoon, by the evening dizziness to where should could not walk. ... Read more
Patients arm started to hurt in afternoon, by the evening dizziness to where should could not walk. On the following day, could barely walk, her speech was low and hoarse and her vision was not good. Given Tylenol by family members with additional food and water. The following day taken to PCP for blood work and a CT Scan w/wo contrast of the brain with lacunar stroke resulted.
89 2021-03-18 weakness TESTED POSITIVE FOR COVID 19 AFTER SECOND VACCINE. Persistent Low Grade Fever, Extreme Fatigue & We... Read more
TESTED POSITIVE FOR COVID 19 AFTER SECOND VACCINE. Persistent Low Grade Fever, Extreme Fatigue & Weakness
89 2021-03-20 tremor within a few days my aunts parkinsons symptoms became so much worse. we contacted her neuro dr who s... Read more
within a few days my aunts parkinsons symptoms became so much worse. we contacted her neuro dr who said that if she had exp a fever or muscle pains after vaccination this was a temp issue. she is now at a month past first vaccine and still exp parkinsons symptoms that are far worse than before vaccination. such as "off times" meaning her parkinsons med will not stop the tremors and as of this past week she is exp parkinsons induced hallucinations. her general parkinsons health has gone down hill in last month. she was diag over 6 years ago and has maintained the same level of health since then. she decided to not take the second vaccine bc she couldnt handle worse parkinsons symptoms.
89 2021-03-29 restless legs syndrome, tingling soreness muscle; soreness muscle and joint; stiffness; difficulty swallowing; trouble controlling ha... Read more
soreness muscle; soreness muscle and joint; stiffness; difficulty swallowing; trouble controlling hands and feet; legs are jerking; This is a spontaneous report from a contactable consumer An 89-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6202) via an unspecified route of administration, in Arm Right on 20Feb2021 14:30 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included parkinson's disease, cardiac pacemaker insertion and seafood allergy. Concomitant medications were not reported. The patient received first dose of BNT162B2 (lot number EL1283) on 30Jan2021 at 10:30 on right arm. On 20Feb2021 the patient experienced soreness muscle and joint, stiffness, difficulty swallowing, trouble controlling hands and feet, legs are jerking. All the events were reported as non serious. No treatment was administered for the events. At the time of the reporting the patient had not yet recovered from the events.
89 2021-04-02 pain in extremity, feeling hot My arm is pretty warm and itched quite a lot; My arm is pretty warm and itched quite a lot; My knees... Read more
My arm is pretty warm and itched quite a lot; My arm is pretty warm and itched quite a lot; My knees have bothered me, my legs have bothered me quite a bit; My knees have bothered me, my legs have bothered me quite a bit; It is hard for me to walk since I got the shot; This is a spontaneous report from a contactable 89-year-old female patient reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EM9809, Expiration date: 30Jun2021), via an unspecified route of administration on 04Feb2021 at single dose for covid-19 immunization. The patient relevant medical history included diabetes mellitus. Concomitant medications were not reported. On an unknown date, the patient experienced her arm was pretty warm and itched quite a lot, her knees have bothered her, and her legs have bothered her quite a bit. It was hard for her to walk since she got the shot. It reacts a little bit in the arm of older people. The patient did not take treatment for the events. The outcome of the events was unknown.
89 2021-04-11 weakness The patient presented to the Medical Center Emergency Department 03/30/21 for evaluation of malaise ... Read more
The patient presented to the Medical Center Emergency Department 03/30/21 for evaluation of malaise and cough that had been present for approximately one week. The patient also complained of shortness of breath, fever, and low O2 saturations. The patient's daughter reported the patient had been more weak and complaining of muscle aches. The patient's caregiver testes positive for COVID-19 1-2 weeks prior. The patient received both Pfizer Vaccines and was more than 2 weeks out of her most recent vaccination per daughter. No additional details regarding the vaccines could be obtained. The patient remained in the hospital and was treated for acute hypoxemic respiratory failure secondary to acute COVID-19 Pneumonia. She was stabilized on 2L supplemental oxygen and discharged home 4/3/21. She received dexamethasone, antibiotics for concern of secondary bacterial pneumonia co-infection, oxygen, mucolytics, antitussives, incentive spirometry, and remdesivir.
89 2021-04-16 severe one side paralysis, unresponsive to stimuli resident unresponsive verbally and favoring L side with R side flaccid unable to take AM med. The wr... Read more
resident unresponsive verbally and favoring L side with R side flaccid unable to take AM med. The writer obtained BS 90. The resident has R side face drop with drooling noted. The resident responded to painful stimuli only. Pupils dilated. Supervisor at bedside BS 102 rechecked. The family opted for comfort measures only. Age 68 On 2/15/2021 Z51.5: ENCOUNTER FOR PALLIATIVE CARE, Patient expired 2/23/2021
89 2021-04-16 tingling, numbness low b/p coupled dizziness; Hx of Cerebral infarct; numbness to limbs Age 89 Note: Resident came ... Read more
low b/p coupled dizziness; Hx of Cerebral infarct; numbness to limbs Age 89 Note: Resident came back from the emergency department at medical center at 1:45.The resident is alert and oriented. The resident has been diagnosed, with deconditions, paresthesia, and gait instability. CT of the head was reassuring. No significant labs or EKG abnormalities noted. No new medications order received.
89 2021-04-22 migraine Felt fine the same day. The next day:. Shoulder SEVERELY swollen with HUGE bump in and around lymph... Read more
Felt fine the same day. The next day:. Shoulder SEVERELY swollen with HUGE bump in and around lymph node, reddened, swelling, heat at inj. site, turned pink then purple then dark purple, throbbing in neck and head, severe headache plus migraine, difficulty hearing, could not move arm/wrist/fingers/hand, unable to hold fork etc. This lasted for 10 days after onset.
89 2021-04-22 cold extremities, weakness Extreme weakness, inability to sit upright for extended period of time, extreme fatigue with walking... Read more
Extreme weakness, inability to sit upright for extended period of time, extreme fatigue with walking short distances, diarrhea/loss of bowel control, extremely pail skin, cold extremities, low blood pressure. Started approximately 27 hours after vaccine and continued to get worse. Dr. was consulted and diagnosed Shy-Dragers Syndrome related to Dementia as a possibility. We were to increase salt intake and observe for worsening. Patient began showing improvement after about 5 days. Was taken to hospital ER for UTI evaluation per Dr.; no UTI present but bloodwork showed the need for a two-unit blood transfusion.
89 2021-04-24 migraine I got sick for a week; Migraines; This is a spontaneous report from a Pfizer. A 89-years-old contac... Read more
I got sick for a week; Migraines; This is a spontaneous report from a Pfizer. A 89-years-old contactable female consumer (patient) reported for herself she received BNT16B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included blindness, rheumatoid arthritis, fibromyalgia, osteoporosis, scoliosis, intervertebral disc protrusion, arthritis from an unknown date. The patient's concomitant medications were not reported. The patient experienced sick for a week, migraines on an unspecified date. The patient stated that the patient got sick for a week. Her rheumatoid arthritis was so bad that she can't open anything. Patient then mentioned having migraines. Patient then stated she was a nurse and hurt herself, my back. She had arthritis, fibromyalgia, osteoporosis and went to a surgeon for scoliosis. She had 9 docs with no cartilage. She had herniated bulging discs and was cut down my left side. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
89 2021-04-30 bell's palsy Bell's Palsy 09Feb2021 dx 12Feb2021; This is a spontaneous report from a contactable Physician. An 8... Read more
Bell's Palsy 09Feb2021 dx 12Feb2021; This is a spontaneous report from a contactable Physician. An 89-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1, intramuscular on 23Jan2021 at 13:15 (Batch/Lot Number: EL3247) as single dose (at the age of 89 years-old) for COVID-19 immunisation. Medical history included high blood pressure, spinal stenosis, kyphosis and known allergy to sulfa-hives. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included donepezil, methadone, sertraline, hydrocodone, metoprolol, alprazolam (XANAX), nifedipine, mirtazapine, hydralazine, and spironolactone; all taken from unknown dates for unspecified indications. On 09Feb2021 the patient experienced Bell's palsy (diagnosed on 12Feb2021). The event resulted in emergency room visit. Therapeutic measures were taken as a result of Bell's palsy and included steroids and acyclovir. The patient was recovered from Bell's palsy on an unknown date. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 28Feb2021 at 14:15 (Lot number EN6203) for COVID-19 immunisation. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported Bell's palsy and the use of BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
89 2021-05-04 depressed level of consciousness 04/04/2021 - Assessed at start of shift. Family at bedside and aware of condition. Left after asses... Read more
04/04/2021 - Assessed at start of shift. Family at bedside and aware of condition. Left after assessment. Unable to arouse. BP 97/64 P 71 R 30 and shallow 02 sat 80% with 02 per NC in place at 2 LPM. Afebrile at 97.7. MS given at this time. Upon entering room at 2245 Pulse faint and R very shallow at 4. Resp. and pulse ceased at 2300.
89 2021-05-05 inability to speak, speech disorder, slurring She had her second dose of the covid vaccine approx 8 days ago, the day after she was very tired and... Read more
She had her second dose of the covid vaccine approx 8 days ago, the day after she was very tired and slept all day. Then yesterday when she awoke she had a sense of discomfort in the left eye, and a friend who helps them at home noticed that her left eye was slightly bloodshot. Yesterday she went to see her eye doctor who dx her with an incidental small burst blood vessel but did not advise stopping eliquis and said it should resolve within weeks. She has no loss of vision. However, in the evening when at home she said she had difficulty forming words - husband did not particularly notice a problem - she ignored it basically and went to sleep . Then this morning went to the hairdresser, noticed the word finding/ speech 'garbled' slightly problem again and walked into her pcp office - she was eval'd there at approx 1140 am and sent to ER by ambulance. Code green not called given the initial deficit was last night, CT head suggested possible subacute infract. She had no chest pain or pressure, trop noted as slightly elevated at 129 , Platlets 84 Diagnosed with Bilateral punctate infarcts throughout the brain, in cerebellum, occiput, left temporal and parietal lobes
89 2021-05-07 pain in extremity, migraine, numbness severe allergic reaction; Swollen lymph nodes; unable to move her left side of her body; muscle and ... Read more
severe allergic reaction; Swollen lymph nodes; unable to move her left side of her body; muscle and joint pain; muscle and joint pain; total numbness of her body; severe migraine; Headache / head pain; Injection site redness; Injection site swelling; arm was hurting a lot; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot unknown, first dose) solution for injection intramuscular in the left arm on 06Apr2021 at 13:30 (at the age of 89-years-old) as a single dose for COVID-19 vaccination. Medical history included seizures from 1970, serious migraines (would guess this was diagnosed about the same time as the seizures) from 1970, broken leg and ankle (diagnosed 4-5 years ago, she can't walk), severe arthritis (this was diagnosed about 5 years ago), Blood pressure high, and uses a walker and a wheelchair (prior to getting the vaccine). There were no concomitant medications. On 07Apr2021, the patient experienced severe allergic reaction, swollen lymph nodes, unable to move her left side of her body, muscle and joint pain, total numbness of her body, severe migraine, headache, injection site redness, and injection site swelling. In Apr2021, the patient experienced arm was hurting a lot. The patient went to the emergency room because she couldn't move the left side of her body, had a really bad migraine, and her head started hurting, but she didn't stay in the hospital. Treatment for the event migraine included acetaminophen (TYLENOL) but that was not doing anything. Shots of prednisone was offered for migraine but the patient refused. The outcome of the events allergic reaction, swollen lymph nodes, muscle and joint pain, total numbness of her body, severe migraine, headache, injection site redness, and arm was hurting was unknown. The outcome of the events unable to move her left side of her body and injection site swelling was recovering. Information about lot/batch number has been requested.
89 2021-05-12 tingling After receiving a COVID vaccination, patient experienced mild SOB, tongue swelling and tingling. She... Read more
After receiving a COVID vaccination, patient experienced mild SOB, tongue swelling and tingling. She was treated with Benadryl while she was at the vaccine site.
89 2021-05-27 weakness Nurse did not believe my mother when told she already had both vaccinations (Pfizer-lot #EL5318-2/12... Read more
Nurse did not believe my mother when told she already had both vaccinations (Pfizer-lot #EL5318-2/12/2021 and Pfizer-Lot#EN5318 3/5/2021. Nurse had my mother sign authorization form. She had immediate fatigue, weakness and exhaustion. This continued and her overall health declined until she was admitted to Acute Care Facility on May 25, 2021. She went from walking with a walker (50-60 feet with assistance) , to only walking 4 steps with max assistance.
89 2021-05-28 night sweats Night sweats; chills; This is a spontaneous report received from a contactable consumer (reporting f... Read more
Night sweats; chills; This is a spontaneous report received from a contactable consumer (reporting for herself). A 89-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in left arm on 23Jan2021 16:00 as single for covid-19 immunisation. The patient's medical history included diabetes, congestive heart failure and cancer from an unknown date and unknown if ongoing. The patient previously took codeine and experienced drug hypersensitivity. The patient had no covid prior vaccination. Since the vaccination, the patient not been tested for covid-19. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. On 02Feb2021, the patient experienced night sweats and chills. Treatment was not received for events. The events were assessed as non-serious by reporter. Outcome of the events was not recovered. Information on the lot/batch number has been requested. Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
89 2021-06-03 weakness Extreme Fatigue; Headache; Loss of appetite; Weakness; Low Grade Fever; Nausea; Th epatient received... Read more
Extreme Fatigue; Headache; Loss of appetite; Weakness; Low Grade Fever; Nausea; Th epatient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021; Th epatient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 89-year-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 14:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included heart & ureter Stents, mild heart attack, stroke, pacemaker, hysterectomy, temporary nephrostomy, blood pressure, pain, sulfonamide allergy and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.Concomitant medication(s) included mirtazapine (MIRTAZAPINE); blood pressure medication (unspecified), statins medication (unspecified) and pain medication (unspecified) all taken for an unspecified indication, start and stop date were not reported. The patient previously took isosorbide, heparin and experienced drug hypersensitivity. The patient previously received first dose of bnt162b2 (BNT162B2) via an unspecified route of administration on Feb2021 at 02:15 PM (Batch/Lot number:Unknown) as SINGLE DOSE for covid-19 immunisation and expereinced fatigue, vomiting, diarrhea, headache, loss of appetite and low grade fever lasting over 3 weeks. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received first dose of BNT162B2 on Feb2021 and second dose on 08Feb2021. On 09Feb2021, the patient experienced extreme fatigue, headache, loss of appetite, weakness, low grade fever and nausea. Therapeutic measures were taken as a result of extreme fatigue, headache, loss of appetite, weakness, low grade fever, nausea with otc tylenol, zofran. The outcome of the events extreme fatigue, headache, loss of appetite, weakness, low grade fever, nausea were recovering and unknown for other events. Information about lot/batch number has been requested.
89 2021-06-05 myelitis transverse Transverse myelitis
89 2021-06-20 tremor, weakness shaking, loss of balance, stomach issues, cant walk without a walker, weakness,
89 2021-07-27 weakness I got a blood blisters on my mouth and it is after 6 week I still have a spot on my lips where blood... Read more
I got a blood blisters on my mouth and it is after 6 week I still have a spot on my lips where blood blister; I had loss of balance; I could not walk; I was short of breath/Trouble breathing; I had blotting stomach; I had pain in my head; I had trouble sleeping; I was very weak; I have a problem with my memory; I was so ill; I feared I would die I was so sick; This is a spontaneous report from a contactable consumer or other non hcp. A 89-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: ER8733) via an unspecified route of administration on 06Apr2021 at the age of (89-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced that she had loss of balance, could not walk, short of breath, blotting stomach and trouble breathing, pains in my head and trouble sleeping and she got a blood blisters on her mouth and it was after 6 week she still had a spot on her lips where blood blister was it was not painful, but she was very weak. She had a problem with her memory. She took Benadryl first and it did not really help after 3 or 4 weeks and then did not help she visited the emergency room for two times and later she went to doctor cabin for several times. This was how ill she was and eventually she had problems with Prednisone (Not clear and not clarified). She informed that she was so ill and did not take the second shot. The patient stated that she was very very ill, and she and her husband went to cemetery, a place where she could be buried because she feared she would die she was so sick, and her husband had a shot, and he was absolutely fine. The patient reported that there were people like who did not help and actually made her very ill maybe it was her age maybe it was her chemistry but it was definitely not for every single person. The patient finished taking drugs as she took them for a period of time (completed the course). She was not taking any drug and she was recovered, and she was doing better and her health was better. The patient took treatment for all the events. The outcome of the event the problem with her memory was not resolved whereas other events were resolved on an unknown date. Follow-up attempts are completed. No further information is expected.