Pfizer

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.

Fatigue, Chills, Low grade fever, Muscle aches. Resident also developed cellulitis to lower portion of arm in which vaccine was administered within 24 hours or less of receiving vaccine and had no previous indication of abnormalities to arm or s/s of infection to arm.

Sluggish feeling on 1/16/2021; extreme thirst chills, gassy, loose bowel movement - caramel color . Injection site soreness; today 1/18/21 slight headache - Tylenol dose, headache now subsiding; all other symptoms have resolved.

fever up to 103, chills, aches, malaise, abd pain, vomiting, went to the ER had IVF abnormal labs, + non st elevation MI

Severe chills/tremors.....my entire body was shaking/spasming. It shook my bed and woke me up. Severe sore arm at injection site.

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

Late in the day of the shot on 01/21/2021, site on arm began to hurt and got worse in the increasing 2 days. Red very warm rash began at the injection site and spread to the size of a soft ball. Today, 01/25, the site is still red and swollen but not as poinful. Temperature is normal. Along with the affected infection site from 01/21, had a series of fevers ranging from 99.9 - 100.9. Usual body temperature is 97.6. Along with this, severe body aches, fatigue, malaise, deep depression and bed stay for 2 1/2 days. Took Tylenol. Today, 01/25/21 at 11:27AM, temperature is 98.3.

Cough; has a metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient) reported that a 76-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number and Expiration Date unknown) via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient was getting a cough and has a metallic taste in her mouth in Jan2021. Wanted to know if it was from the vaccine or Covid. The outcome of events was unknown. Information on the lot/batch number has been requested.

Diarrhea; Swollen, very sore, hot arm by injection site; Swollen, very sore, hot arm by injection site; Swollen, very sore, hot arm by injection site; Fever; Very tired; Achy; Headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 02:00 AM on 10Jan2021 at single dose for COVID-19 immunization. Medical history included thyroid disorder, reflux, elevated blood pressure and elevated cholesterol. Concomitant medication included lamotrigine, buspirone, levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and others. The patient previously took compazine and experienced drug allergy. The patient experienced swollen, very sore, hot arm by injection site. Fever. Very tired. Achy. Headache at 05:00 PM on 10Jan2021. 3-30 hours after injection. Diarrhea (more than 6 times) 44 hours after injection and ongoing on 11Jan2021. Prior to 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 treatment for events. The outcome of events was recovering. Information on the Lot/Batch number has been requested.

Patient vaccinated at 1215. Reaction began at 1250. Pt was told she would be observed for 30 minutes due to previous history of a reaction to the typhoid vaccine. After 30 minute observation patient stated she was light headed, dizzy, warm, and nauseous. Nausea subsided at 1325. Stated she was still dizzy at 1335 and stated her throat started to feel scratchy and difficult to swallow. Rapid Response called and patient evaluated. Patient transported to ED for further evaluation.

Day 1 moderate to severe pain at site and headache treated with Acetaminophen. Extreme sleepiness for 48 hours and slept for most of the day. 2nd Day pain at site and headache continued. Treated with Acetaminophen. Extreme sleepiness slept for most of the day. Sore throat,cough and nasal congestion and drip, and metallic taste in mouth. Loss of appetite. Loss of hearing and appetite. I woke up at night at 1:00 a.m. with severe nasal discharge and had to sit upright for 2 hours till it abated a little. Day 3 Pain at site continued as did nasal congestion and discharge. Loss of appetite and hearing also continued. I still have nasal congestion and discharge on my 3rd week and also the loss of appetite and hearing loss. The loss of hearing has improved very minutely.

1/23/2021 extreme vertigo at 10:00 AM lasting aabout 2 minutes 1/25/2021 at 4:00AM woke out of a sound sleep with strange sensation of spinning. dlosed eyes tights and fell back asleep That morning upon waking at 6:00 AM and getting out of bed, I could not walk and I was extremely dizzy. I made myself get up and all i could do was stumble. Had to hold on to wall. could not put one foot in front of the other. My head felt very heavy like it wasnt attached right..... after Deep breathing and other calming techiques during the day, I was able to walk straight. Tues 1/26/2021 I contacted my Doctor and told him my story. 1/27/2021 I developed a rash across my nose and cheeks which is today.

headache; nausea; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3247), via an unspecified route of administration on the left arm on 14Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included depression and anxiety from an unknown date and unknown if ongoing. Concomitant medication included alprazolam (ALPRAZOLAM), melatonin (MELATONIN), escitalopram (ESCITALOPRAM). The patient experienced headache and nausea on 16Jan2021 19:00. The outcome of the event was recovering.

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

I had no reactions with the first dose. The next morning on the 28th I woke up and couldn't get out of bed. I tried to get out bed and couldn't my husband had to come help me. I could barely walk because I hurt so bad. He helped me to the bathroom and then to my chair in the living room. It hurt so bad I couldn't stay long. My husband helped me back to bed, I stayed in bed all day besides when I needed to go to the bedroom. Today I am shaky, my stomach is bothering me, I can walk today but I real tired and shaky and have to come right back to my chair to sit down. I am better then I was yesterday. If I don't feel better by noon I will call my doctor.

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.

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.

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.

Patient reported scratchy, irritated throat with some tightness. She was able to swallow and reported that drinking water made her throat feel better. No chest pain or shortness of breath. She reported some anxiety. VS: BP 133/81, HR 83, O2 sat 96-97% on RA Patient felt stable and went home after over 30 minutes of observation.

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.

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.

loose stools; gut hurting; Headache; This is a spontaneous report from a contactable consumer reported for self. This 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 10:30 arm right way high at single dose for covid-19 immunisation. Her 2nd dose is schedules for 09Feb2021. She states that the Lot and Expiry were not written, it just says (Name) for healthcare professional or clinical site. This was her first dose for the Covid 19 vaccine she received, it says Pfizer. Medical history included stomach ulcer, Resection of Small Intestines, 18 months ago, it was complete right side resection of the small intestine, it was pre colon cancer and they took out 10 inches, AFib, It was discovered almost exactly a year ago (from 2020), Graves' disease, headaches. Concomitant drug included rivaroxaban (XARELTO) for Atrial fibrillation and a blood pressure medication. The patient previously received Flu shot in Sep2020 at 75 year old for immunization and shingles shot in 2020 for immunization. The last 2 vaccines she got were shingles and Flu shot, and this last year 2020, for the first time in her life she had a little bit of a reaction, it was in particular, the shingles shot, she felt unwell. The reaction she was speaking of with the shingles shot earlier was that she just felt unwell, but not severe. It was for about a day. She has no name and no Lot number for the Flu shot and Shingles shot, what ever the Flu shot was for 2020, she got it in Sep2020. She went to drug store, the shingles shot was the new 2 shot shingles or something like that, in which it is also 2 doses. She only had trouble the 1st time, it was the little reaction and next time there was no reaction or vice versa, but nothing severe. She kept thinking, she was a worry wart. She thought that she must have Covid 19. Her daughter laughed at her and said that she did not have covid because she did not have the correct symptoms for covid, but she has to ask it would not help her if she was going to die. Her husband and her had the first dose Friday at like 10:30AM, she Lives an hour away from the site. She had not felt one thing in her arm, no soreness no puffiness, no redness. She was having trouble with her Gut hurting and she was running to the bathroom with loose stools. She did not have a temperature and she does not have any aches and pain. It was diarrhea but not watery, there was some form to it. The gut symptoms started on the same day, possibly in the evening, about 19:00 at night. The Loose stools also started on the 15Jan2021 around the same time. During the night, last night, more so in the middle of the night, her gut really started to feel better, but she has had 2 bowel movements this morning, but it was still very soft. The Loose stools are still on going, but she felt better this morning. She didn't feel "sicky." She felt she was going to live. She has never had a fever. She did have a headache on 15Jan2021, especially when she was worrying. Lab data included investigation: She had physical for the year in Nov2020. Outcome of the event loose stools, headache was resolving. Outcome of the event gut hurting was recovered on 18Jan2021. Information on the Lot/Batch number has been requested.

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

Chest tightness; hives on the side of her neck; scratchiness in throat; gums were throbbing; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EJ1686, Expire Date: 30Mar2021), intramuscular at Deltoid Left on 15Jan2021 11:08 at the 76 years old at 0.3 mL, single for COVID-19 immunization. The patient medical history included allergies issues with shellfish (allergic reactions), hyperlipidemia and hypertension. The concomitant medications were none. There was no additional vaccines administered on same date of the suspect. The patient was experienced for over 20 minutes with no side effects. After she left on an hour after administration (15Jan2021 12:08), she started feeling scratchiness in throat, her gums were throbbing and chest tightness. She did say she didn't take any Benadryl. She didn't have airway issues, but she did have hives on the side of her neck on 15Jan2021 12:08. She got the shot on 15Jan2021. The side effects started shortly after she left on an hour after administration. Her symptoms were relieved by 15Jan2021 21:30, and she got the shot at 11:08 am. The patient had allergic reactions in the past. She knew what to expect. She got the shot in her Left Deltoid. The reporter had a gut feeling she didn't need to get the second dose. The reporter assessed all the events were not serious. She did not require medical intervention. She did not go to the Emergency room or Physician Office. The patient was not hospitalized, or in the ICU. The Causality was not provided by the reporter. The outcome of the events was recovered on 15Jan2021 21:30.

Body Chills; body aches; nausea; 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, lot EL9261, expiration date unspecified), via an unspecified route of administration on 16Jan2021 08:30 at single dose (left arm) for COVID-19 immunization. Medical history included Covid-19, prior vaccination. The patient was not pregnant. Concomitant medications were not reported. Patient had other medications in two weeks. The patient previously took codeine (reported as codine) and experienced allergies. On an unspecified date, the patient experienced body chills, body aches and nausea. There were no treatment for the events. There were no other vaccine in four weeks and patient was not Covid tested post vaccination. Outcome of events was recovered in Jan2021.

tested positive; tested positive; being a little tired/she was tired after it; 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: EL1283, expiry date: 30Apr2021) solution for injection, via an unspecified route of administration on 15Jan2021 at a single dose for Covid-19 immunization. Medical history included hearing aid. There were no concomitant medications. The patient reported she received her first dose on Friday 15Jan2021 and she lost her sense of smell and taste on Sunday 17Jan2021 and she went and got tested today, Monday 18Jan2021 and her rapid test was positive (Covid test). her taste and smell ability disappeared. She stated that yesterday at 3:30PM all of sudden that her taste and smell ability disappeared. Stated that she just had a rapid test done. Stated that she had not felt bad and had no symptoms before the shot. Patient wanted to know if they had any reactions like this. Stated that she will know more when the test comes back, and she will hear shortly. Patient stated that she was tired after it (Jan2021). She was being a little tired. Stated she has a hearing aid which she had prior to getting the vaccine. Outcome of the events lost her sense of smell and taste/her taste and smell ability disappeared were not recovered, while outcome of the other events was unknown. No follow-up activities are needed. No further information is expected.

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.

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,

Patient developed chills, nausea, headache, body aches, loss of appetite. She went to the emergency room and received Benadryl and a bolus of normal saline, She is feeling back to her baseline today,

After second, very ill with fever, body aches, headache, debilitating lassitude headache. Lasted 36 hours.

headache; she had a mild soreness in her left arm after getting the COVID-19 Vaccine; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer-sponsored program Pfizer First Connect. This pharmacist reported similar events for two patients. This is the first of two reports. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1283) via an unspecified route of administration on 19Jan2021 10:30 AM at single dose on left arm for COVID-19 immunization. Medical history included temporomandibular joint (TMJ) pain in jaw and headache. Concomitant medication included Tylenol for temporomandibular joint (TMJ) pain in her jaw. The patient (retired pharmacist) stated that she and her husband got the COVID shot on Tuesday (19Jan2021) and prior to getting the vaccine, she was suffering temporomandibular joint (TMJ) pain in her jaw and took Tylenol that morning. Patient just came back from urgent care and was prescribed a dose pack of prednisone to take for 5 days for the TMJ and she is concerned about taking it because she knows it can suppress the immune system and she does not want to make the vaccine less effective. She was trying to figure out if she should just tough it out and not take the steroid. She and her husband, who was on warfarin, had a mild headache after the first shot but he has sinus issues and she had the TMJ, they were not sure if the headaches were from those things or the vaccine. Patient asked if she can take Tylenol since she found out that that may not have been a good idea. She was advised to take Prednisone and she was asking if she can take it or will it affect the efficacy of the vaccine. She stated not knowing that taking Tylenol can effect the efficacy of the COVID-19 Vaccine, she had taken Tylenol before she received her COVID-19 Vaccine on 19Jan2021 (Tuesday). Patient said her TMJ jaw pain was still a problem after she received her COVID-19 Vaccine, so she had gone to her doctor, and her doctor prescribed Prednisone, a corticosteroid. She said she was not going to take the Prednisone because she does not want the Prednisone to cause an issue with the efficacy of the COVID-19 Vaccine. Patient said she then read that studies performed on children said that children that took Tylenol did not get as good of an immune response from the COVID-19 Vaccine. Patient said since she already took a dose of Tylenol for her TMJ jaw pain before receiving her first COVID-19 Vaccine dose, she was afraid to take any further Tylenol. Patient clarified that the Tylenol she took was the generic Equate brand, 500mg. She said she took 2 Equate brand generic Tylenol 500mg for jaw pain on Tuesday morning (19Jan2021) prior to getting her first COVID-19 Vaccine. She said she had disposed of Equate brand generic Tylenol bottle and cannot provide the UPC, Lot and Expiration Date. Reported that both her and her husband did have a headache all day long after receiving the COVID-19 Vaccine. She said her husband believes his headache was from the COVID-19 Vaccine. She said she was not sure if her headache was from the COVID-19 Vaccine or from her TMJ jaw pain. She said when she has TMJ jaw pain, she usually has a headache accompanying the TMJ jaw pain. Also reported that she always gets her vaccines in her left arm. Patient was surprised she and her husband did not have anything more than a headache after receiving the COVID-19 Vaccine. She said when she had the Shingles Vaccine, she could not lay on her left side for a week because her arm was so sore for 2 days, and when she had the flu shot she could not get out of bed for a day. Patient clarified she got her first dose of the Shingrix Shingles Vaccine in Nov2020, and does not plan to go and get her second Shingrix dose until the summer of 2021. Patient stated that she does not want the second dose of the Shingrix Vaccine interfering with the COVID-19 Vaccine. The patient had headache on 19Jan2021, reported as mild. Patient also had a mild soreness in her left arm after getting the COVID-19 Vaccine on 19Jan2021, and the left arm soreness was gone in less than 24 hours. Patient further clarified that she had a headache before getting the COVID-19 Vaccine. She said her TMJ jaw pain acts up if she eats. She said when she has TMJ jaw pain, she gets an excruciating headache. She said she has no headache pain at all right no. Patient expected to have kind of a worse reaction to the COVID-19 Vaccine based on what other people have been saying. The events were assessed as non-serious. Outcome of the event headache and mild soreness in her left arm was recovered in Jan2021. Patient does not think her headache pain was related to the COVID-19 Vaccine.; Sender's Comments: Based on the time association and drug's safety profile, the possible contribution of suspect vaccine BNT162B2 to the event headache cannot be totally excluded. The underlying temporomandibular joint and headache may be cofounders.,Linked Report(s) : US-PFIZER INC-2021082288 same drug/reporter, similar events, different patient

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.

not feeling well/general malaise/feeling sick; feeling really bad; a bad headache; feeling sick and nauseated/nausea; worried it will not go away; frustrated; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELI283, expiry date unknown), via an unspecified route of administration in the right arm, on 11Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported she had her first vaccine on 11Jan2021. On 19Jan2021, the patient was feeling really bad, had a bad headache, general malaise and was feeling sick and nauseated. She was not feeling well and has not been feeling well the last 3 days. She thought the side effect would be right after getting the vaccine however hers started on 19Jan2021 (2 days ago). She stated she had an awful headache which she still has and had nausea. She wanted to know if it was normal to have happened this far away from receiving the vaccine, this amount of time from the vaccine. The patient reported that she is not quite as bad now, but she still feels it. The patient was worried it will not go away (Jan2021). The patient became frustrated and stated that she was just trying to find out if what she was feeling was normal. The patient also thought she had COVID and took a test in Jan2021 but she did not have COVID (negative). The outcome of the events "not feeling well/general malaise/feeling sick", "feeling really bad", "a bad headache" and "feeling sick and nauseated/nausea" was recovering; and the outcome of "worried it will not go away" and "frustrated" was unknown.

Headache, nausea, fever, chills, aches all over, extremely tired. Slept for about10 hours and took 2 Tylenol. Fever disappeared and nausea got better after about 12 hours Still have some fatigue that is not normal for me.

headache, nausea, severe myalgia -cervical/thoracic; pt had to take Tylenol and when that didn't work she had to take hydrocodone to get some relief.

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

flu like symptoms--aches, chills, headache, fatigue, followed by red rash over left chest area, with itching Treated with benadryl with little effect. Received Rx for dosepack Prednisone. Also applied cortizone OTC to rash area. Flu like symptoms abated wtihin 36 hours; rash improving more slowly.

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.

slight headache, nausea, not being able to move-sit up, walk, muscle pain, joint pain extreme for one day then a tapering off for about 3 days, Took Tylenol 500mg 2 every 6 hrs for a few days, ONDANSETRON 4mg 1every 8 hrs as needed for nausea

pt states that she developed terrible stomach cramps, chills and change in stools. She says so far today she is no longer having the stomach cramps.

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.

Immediately, within 2 hours of the vaccination, I developed a severe headache, join pain (knees, elbows, mostly legs and lower extremities) which evolved into intense, burning abdominal pain. My blood pressure rose to 160; however, there was no fever, cough or shortness of breath. This condition lasted until the 7am on the morning of February 8th, but pains returned that evening (Monday 2/8) through Tuesday morning. Symptoms subsided during the day on Tuesday, yet on Tuesday evening (2/9, approximately 48 hours after the injection), severe symptoms returned, similar to the initial evening. I visited my Primary Physician on Wednesday afternoon (2/10) for a consult.

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.

Washed out, just relaxed slight fever, and chills, muscle aches, joint pains, 1 Tylenol and went to bed

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.

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.

Started having fever chills nausea and diarrhea and felt short of breath on 2/13. SOB and diarrhea was better on 2/14 bug then on 2/15 pt started to feel chest pressure. pt admitted to hospital on 2/15 noted to have NSTEMI and plt=68. Thrombocytopenia is new for pt. on 2/16 plt=79. pt has been on ibrance for years for hx of breast ca- has never had thrombocytopenia related to the ibrance.

Woke up at approx 1:30 am on the morning after the 2nd Covid vaccination with a fever of 101 degrees. Took one Ibuprophen tablet. Fever subsided by 7:30 am. Felt exhausted and slept off and on for the next 24 hours. All symptoms gone as of today 2/16/2021.

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.

Patient received second dose of Pfizer vaccine on 02/12. On 02/13 she experienced extreme vertigo. Hx of same but this is worse than her usual. She continues to experience this although it has improved over the days since. She reports nausea starting 02/15 or 02/16 and vomited one time yesterday 02/17. She is experiencing intermittent chills but no fever, highest temp was 97.6.

The first night after the vaccine had a headache and woke up with pain near her mouth. The 2nd night, Tuesday, 2/16/21 it got bad, woke up around the same time early morning, had pain on the right quadrant of her upper body, from her ear, eye, throat and down to right under her throat. When she swallows the pain is very severe with difficulty swallowing and that pain radiates to the upper part of her chest. Then on the third night, last night, all the same pain but the headache had disappeared. Today, 2/18/21 she is still having the same symptoms. The hardest thing to deal with is the ear pain in the right ear, and the pain under her right throat area. She has taken one Benadryl at 8:00 AM, and will take another at 8:00 PM. The Benadryl triggers her tinnitus so is limited with that. Her daughter is trying to find OTC medicine for the ear. She has not called her doctor as they are trying to treat it with OTC medicines. For additional information call her daughter: who takes care of all her medical information.

Patient on 02/09/21 starting having slow thought process and weakness in left arm and hand and had little strength in left hand and was dropping things. patient was scheduled for ct scan for headaches later that week. Called and got ct scan to be done state. Patient had a CT scan on 02/09/21 which was negative and saw the doctor on 02/12/21 and he ordered an MRI which showed patient had a CVA, cerebrovascular accident-stroke, MRI results revealed the CVA.

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

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.

Fever- (100.7) started 14 hours after vaccine and lasted 24 hours Nausiated- started 14 hours after vaccine and lasted 48 hours Extreme Fatigue- started 14 hours after vaccine and lasted 48 hours

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.

Day after vaccine she felt tired, today she woke up coughed up blood then noticed that her nose was bleeding; bleeding lasted about 1.5 hours, now stopped #1 Pfizer 1/31/21 1115 #2 Pfizer 2/20/21 1300 #1 Pfizer lot EL9265 #2 Pfizer lot EN6200

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.

Patient complained of racing pulse, anxiety, dizziness during 15 min observation time. BP elevated 175/91, HR 120-130. pOx 99% RA. talked patient through deep breathing, anxiety reducing exercises. Vitals started to come down (153/71, HR 96). Patient then complained that she was feeling unwell again, very dizzy, HR increased as well as BP again. 911 called to patient to go to ER for evaluation.

Same day pt developed burning pain with urination and fever of 101F the same day. Pt came to the hospital, was not determined to have a urinary tract infections. No fevers during time in the hospital.

pt states that after she got the covid vax and within 10 minutes she started getting light headed so she sat down. After sitting about 10 minutes she felt better but felt like she was having a mild vertigo episode. After she got home , she ate and laid down where she was having another dizzy spell or vertigo episode and was also nauseated. She woke up next day, she got up but felt drained so went back to bed. Through out the night the next night she had chills, nausea, runny nose and bad vertigo episodes. She woke up w/ diarrhea and more vertigo. Pt had an appt w/ her physical therapist today 2/25/2021. They did a procedure to treat her vertigo. She is still having nauseated, having chills and vertigo episodes at this time. Pt states she is going to contact her PCP today.

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.

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.

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.

Pt received dose #2 Pfizer COVID vaccine 1/29/21 @ MAC vaccine clinic. Reported flu like symptoms over the next two days (fatigue, nausea, anorexia). 2/2/21 awoke with abdominal pain and distension. Presented to MHN ED 2/2/21 @ 1100 for workup and initially declined admission and went home. Was called and asked to return for admission and further workup, admitted to MHN 2/2/21 @ 1750. Fever, myalgias, headache. CT abd/pelvis "There is mild diffuse mesenteric edema surrounding the abdominal aorta and proximal branches. Additionally, there is mild bowel wall thickening involving the stomach without discrete mass. This is nonspecific and may represent infectious versus inflammatory changes." Per provider note "flu-like sx over the weekend that easily coincide with the timing of the COVID Pfizer vaccine. In addition, I wonder if her CT scan findings might also be related to the vaccine." Discharged home the next day.

Left side of face pain including eye inside mouth and throat. Felt like bad sinus infection. Still have some throat pain

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

After 12 hours, extreme fatigue, headache,tinnitus, chills then joint and muscle pain I took Aleve and was able to sleep off and on during the night. The following morning still had headache and fever. I could not eat breakfast. I took a two-hour nap during the afternoon. Symptoms dissipated slowly by evening.

Patient began feeling tired 1 hour post dose. At 3 hours post dose, patient began feeling woozy, dizzy and disoriented. Patient got dizzy and passed out while walking to bathroom. She fell and sustained a significant laceration to her arm. She continued to feel dizzy and "just not right" several times over the hour until she finally called 911. When paramedics arrived, she continued to lose consciousness and required full assistance to be placed onto the stretcher. Her BP was all over the place for the better part of 6 hours, with highs as high as 145/95 and lows as low as 81/42. This reaction lasted for a total of 8 hours.

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

Body aches, fever, chills, sore arm, inability to walk after first dose. Second dose more severe symptoms. Headache, nausea, fatigue.

sore throat; Tenderness of the Right Arm; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EH9899), via an unspecified route of administration on the right arm, at age 76 years first dose on 22Jan2021 at single dose for COVID-19 vaccination. Medical history was none. There were no concomitant medications. Patient had the vaccine first dose on Friday (22Jan2021), she had tenderness in the arm at the site but nothing major. Then this morning (27Jan2021) she had a really bad sore throat, it's really sore. She asks if this is a side effect. She asks can she take aspirin or Tylenol. Reporter Type: She has worked in a doctors office in the past but it was just doing medical records. She confirms that on 22Jan2021 was her first dose of the covid vaccine, the tenderness of the arm was on the same day, it happens anytime she gets a shot, the Sore Throat started this morning. Primary care: Declined, she has only been going through the vaccine program. The tenderness of the right arm, is barely there, its like nothing there, its just a little. For the Sore Throat , she drank from tea and had a lozenge and so its not as but is still there but not terrible. Patient stated that she just want to know if she can take aspirin or Tylenol Covid Vaccine Card: The Expiry is not written on the card. Date of second dose: 12Feb2021 Concomitant Medications; No She was just sleeping and woke up with it. The outcome of the event sore throat was not recovered, while for the other event, it was recovering.

headache; chills; muscle pain; tiredness; feeling unwell; 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: EL3302), via an unspecified route of administration at the left arm from 30Jan2021 3:00 PM at SINGLE DOSE for covid-19 immunization. The patient is not pregnant at the time. The patient was vaccinated at a Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included cancer cured. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that there are other medications the patient received within 2 weeks of vaccination, however it was unspecified. The patient previously took demerol and experienced allergy. It was reported that the patient experienced headache, chills, muscle pain, tiredness, feeling unwell on 30Jan2021 09:00 PM. The outcome of the events was recovered. No treatment was received for the adverse events. The case/ events were reported to be non-serious.

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.

Pfizer-BioNTech Covid 19 Vaccine EUA Started getting light headed and dizzy on early morning Sat. Have been having off and on since then. Have not been able to shower, drive for fear of having it happen again. I did have a B12 injection on 2/15/2021 after checking with my physician to see if would be a problem with getting vaccine.

more tired; left arm/injection arm, had a little bit of pain; little more drowsy than normal; 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 number: PFREL1283; expiry date: 30Apr2021) via an unspecified route of administration on 08Jan2021, at single dose, for COVID-19 immunization. Medical history included pre-diabetic, thyroid disorder and cholesterol abnormal. Concomitant medications included levothyroxine for couple of years for thyroid disorder and rosuvastatin for 30 some odd years for blood cholesterol abnormal. The patient reported that with the first shot, she had side effects she was aware of. On 08Jan2021, she was a little more drowsy than normal. It was nothing severe, but when she was up and awake, she could tell she was more tired. That lasted over 3 days. It wasn't like she couldn't do anything. She just felt more tired than normal. It was different than normal. On 09Jan2021, her left arm, which was her injection arm, had a little bit of pain. She understood that though. It lasted a couple of days. Outcome of the event tired was unknown, while for the other events was recovered on 10Jan2021.

Swollen Lympf Nodes(7 days), slight headache(two weeks) tiredness(1 week)muscle aches(1 week),severe itching on back (no rash(2 weeks)nausea(1 day) Tylenol for headache, rest for tiredness, caladryl, Zyrtec, Pepcid for severe itchiness, Dr visit on Feb.22 - had me take a flu/covid test came back negative.

Reported not feeling well, sent to ED. Per Ed note: Patient here from covid vaccine clinic. c/o throat tightness w/ small amount of dyspnea. states throat feeling better now, still having some tightness in chest. Patient received IV benadryl and IV famotidine and felt fine. No need for treatment with epinephrine IM. Was discharged home.

not feeling good; chills; fever, which she thought was a 100.1; headache; nausea; started throwing up; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3246, NDC/UPC number and expiry date were unknown), via an unspecified route of administration on 31Jan2021 at a single dose for COVID-19 immunization. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown) on an unspecified date for COVID-19 immunization. Relevant medical history included heart problem, for which the patient did take "medicine," but it was not specified. All day on 01Feb2021, the patient was not feeling good; she had chills all day and then she had a fever, which she thought was a 100.1; and she had a headache; she had nausea and she started throwing up. The patient did not receive any treatment for the events. The outcome of all the events was unknown.

on 2/16/21 began to have chills in late afternoon persisting into evening. oral Temperature at bedtime averaged 99.6 persisted with decreasing chills by 2/28/21 Please note that received 2nd dose of pfizer on 3/1 and symptoms of chills, inc temperature returned along with nausea thru most of the day on 3/3/21

MS symptoms escalated, everything hurt, major trouble walking, fever for about 24 hours, headache, ache all over.

Very cold, chills, many many trips to the bathroom, flu-like very upset stomach, 101 temp, throwing up ,

Pfizer-BioNTech Covid-19 Vaccine EUA 2 2/2 days post vacine nausea, sore throat, vomiting, abdominal cramps, headache, loose stools, fatigue. Continued for 10 days. Two weeks After 2nd pfizer vaccine, above symptoms once again (no vomiting) and continuing. Basically sick for 5 weeks to date.

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.

Extreme fatigue, muscle pain, headache. Difficulty getting out of bed. Slept 23 hours a day for 6 days. Increasing muscle pains for 3 weeks.

feeling dizziness contacted the patient , patient states that she is not having any more dizziness , but some HA , took some tylenol .

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.

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.

Started with upset stomach and achey body late afternoon on Friday (1 week after 1st shot). Then developed diarrhea at the same time extreme fatigue. Diarrhea only lasted about 1 day, but fatigue ( which demanded many naps) and achey body lasted until Monday night. Woke up Tuesday feeling stronger, but still had lower back ache and tiredness - not extreme fatigue, but still so very tired - fewer naps. Today is Thursday and I am still quite tired, lower sore back ache. Never had a fever.

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.

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)

Joint pain, muscle aches, right shoulder pain, fatigue night after shots and next day Lasted over a period of 2 days

Pain, headache, tiredness, loss of appetite for the 2 days after the injection (February 20th and 21st. ON THE 22nd I WOKE UP TO A SEVERE NOSE BLEED THAT I COULD NOT STOP! I NEVER RECALL HAVING A NOSE BLEED IN MY LIFE! I HAD MY SECOND SHOT ON FRIDAY, MARCH 12, AND WHILE SITTING WATCHING TV MY NOSE STARTED BLEEDING AGAIN EXCEPT, NOT SO PROFUSELY! It seem very strange to me that this would happen days after having the Covid vaccine

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.

tiredness; headache; muscle pain; chills; feeling unwell; injection site soreness; This is a spontaneous report from a contactable nurse (patient herself). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 31Jan2021 at 08:00 AM (at the age of 76-year-old) at a single dose for COVID-19 immunisation. The patient's medical history included coronary artery disease (CAD), hypothyroidism, and sleep apnea. Concomitant medications included levothyroxine, carvedilol, latanoprost, and amlodipine besilate (AMLOD). The patient previously took meperidine (DEMEROL) and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced tiredness, headache, muscle pain, chills, feeling unwell, and injection site soreness on 31Jan2021 09:00 PM. The patient had not taken any other vaccine in 4 weeks. The outcome of the events was recovering. There was no treatment given due to the events. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the Lot/Batch number has been requested.

tiredness; headache; nausea; feeling unwell; muscle pain; joint pain; This is a spontaneous report from a contactable consumer (self-reported) via medical information team. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9261, expiry date unknown), via an unspecified route of administration, in arm left, on 30Jan2021 as single dose for COVID-19 immunization. The patient medical history included Obesity and difficult time metabolizing medications. Family history included her daughter and grand daughter have EDS. She would probably be the genetic carrier. The patient concomitant medication included ongoing esomeprazole sodium (NEXIUM) and she has been on it about 2years, ongoing valsartan and she has been on it about 2 years. It was reported that the patient had experienced Tiredness, headache, muscle pain, joint pain, nausea and feeling unwell; all events on 07Feb2021, and everything is ongoing. The outcome of the events was not recovered.

was ill as soon as she got home; Hasn't been able to get out of bed. The patient states she has been taking ibuprofen but it doesn't help much; Says she's never had to stay in bed this long; We recommended being evaluated by a doctor at an Urgent care center because of continued a/e that are reportedly worsening.

Rash; Fever; Rash or hives are on her legs, thighs, neck, back, and head; Rash or hives are on her legs, thighs, neck, back, and head; This is a spontaneous report from a contactable nurse (patient husband). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EL3247, Expiration date: 31May2021) via an unspecified route of administration in the right arm on 01Feb2021 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient relevant medical history included allergy. The concomitant medication was not reported. The patient previously took septra and experienced allergic to septra (she had taken many years ago. She took something and developed an allergy, but she hasn't used it in maybe 20 years). It was reported that patient received first dose of the Pfizer COVID-19 vaccine on Monday (01Feb2021) and she felt good, then late Tuesday she got a rash at 09:30 (about 30 hours after her injection) and a fever on (02Feb2021), which was listed on the brochure and was kind of expected, but he wanted to be reassured this was ok and not something like a severe allergic reaction. It was reported that patient second dose was scheduled for 22Feb2021. It was reported that patient has been taking Benadryl 25mg, 50mg total a day, 25mg one in the morning and then one in the evening by mouth. The reporter informed that the benadryl (Lot number: P119020, EXP: Feb2022) seems to calm the rash down, though it was more like hives than a rash. It was reported that patient had rash or hives are on her legs, thighs, neck, back, and head on an unknown date in Feb2021. The reporter told that the rash was not getting worse, and Benadryl seems to help it. The reporter told that the vaccine instructions they got said it was possible to get a rash or have a side effect, he just wanted to be reassured. Therapeutic measures were taken as a result of rash, rash or hives are on her legs, thighs, neck, back, and head. The outcome of the event fever was unknown while for other events was recovering.

Fever of 101.4; Chills; Aches; Fatigue; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EL9263) as SINGLE DOSE for an unspecified indication. Medical history included ongoing acute myeloid leukaemia, ongoing hypertension. Concomitant medications included gilteritinib fumarate (XOSPATA) taken for an unspecified indication, start and stop date were not reported; timolol taken for an unspecified indication, start and stop date were not reported; lisinopril taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; latanoprost (LATANOPROST) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. The patient experienced fever of 101.4 (pyrexia) (non-serious) on 30Jan2021 10:00, chills (chills) (non-serious) on 30Jan2021 10:00, aches (pain) (non-serious) on 30Jan2021 10:00, fatigue on 30Jan2021 10:00. The patient underwent lab tests and procedures which included body temperature: 101.4 on 30Jan2021. There was not treatment received for the adverse events. The events were considered as non-serious by the other healthcare professional. The outcome of the events were reported as recovered.

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.

Headache first and 2nd day. A week later woke me up 2 nights in a row but only lasted 12-15 minutes. Skipped heart beats day after and the next am, none since. Rash of red irregular dots about the size of a pencil eraser with bumpy raised flesh directly on veins. started 2 weeks after, lasted 4 days, loss of appetite, much more intense joint pain and sleeplessness which comes and goes.

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).

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.

half hour after receiving shot tongue and throat swelled up and short of breathe. Throat was sore for few days and short of breathe remained for almost a week It is 12 days and feel better but do not know if I should get second shot

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.

Fine after shot and evening; went to bed approximately at 9pm and got so cold, put 3 blankets on and was fine. Got up about 2AM to go to the bathroom; started back to bed; had a bad taste in mouth, so decided to brush my teeth. Started brushing and all of a sudden, felt faint; before I could get the toothbrush back, I fell and my husband rushed over. Said I was out completely; got me awake and back up and went to bed and slept. until 11am. At 3pm when taking a shower, noticed my left shoulder blade was real sore and looked and there were 3 red strips below should blade - no bleeding tho. top R. side of head kinda sore, so must have hit when falling. Went back to bed and slept good. Didn't need to go to the Dr. and am feeling good now. Just rested for a couple days. Had been feeling really good and don't take any prescriptions, so could only think it had to have something to do with the shot. Today is the 4th day and feel good.

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.

right side sore throat on 02Feb2021 for 2 days and still slightly painful; Feeling unwell; I had the flu for 2 days on 28Jan2021; 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 Number: EL1283) via an unspecified route of administration in the let arm on 25Jan2021 13:00 (at the age of 76-year-old) , single for COVID-19 immunisation. The patient relevant medical history included mitral valve prolapse, Allergies to medications, food, or other products: Codeine, Dexamethasone, Keflet, Paxil, Sulfa Class, Tetracycline. Concomitant medications included propranolol hydrochloride (INDERAL); estrogens conjugated (PREMARIN); lisinopril (LISINOPRIL); digoxin (DIGOXIN) all were taken for an unspecified indication, start and stop date were not reported. Feeling unwell like I had the flu for 2 days on 28Jan2021 12:00 AM and right side sore throat on 02Feb2021 for 2 days and still slightly painful. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient not been tested for COVID-19. Outcome of the event right side sore throat on 02Feb2021 for 2 days and still slightly painful was recovering and Outcome of the other events was recovered on unspecified date in 2021.

Phizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, headache, chills, fever, nausea, feeling unwell, dizziness & weakness

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

Visited PCP on 3/8/21 with reports of nausea, fatigue, and anorexia following COVID-19 vaccine. Reports body aches, nausea without vomiting, abdominal pain, diarrhea, runny/stuffy nose. Presented to ED on 3/9/21 and reported shortness of breath started 2/28/21. Had COVID positive contact on 2/24. Required supplemental oxygen on presentation. Admitted to ICU on 3/14/21 until present.

12 hours post vaccination I developed chills, headache, unable to relax (shaking). 24 hour post vaccination I was exhausted and slept for 24 hours. Now, at day 3 post vaccination, I am still tired, unable to do anything that requires exertion.

1st vaccine on 2/20 and reported feeling "lousy" afterwards. On the evening of 2/23 felt like she was going to pass out. Felt worse when she woke the next morning. Presented to the ER on 2/24 with chest pain and "indigestion". Found to be in A.Fib with RVR. Vomited in ER triage. On 2/25 developed altered mental status, hypotension, hypoxemia. She was intubated and transferred to the ICU with severe lactic acidosis/shock/multiorgan failure. Had Right lower lobe infiltrate and right pleural effusion. Diagnosed with pneumonia and possible ischemic bowel. Died on 2/26. Family requested autopsy.

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.

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

3/5 Anxiety attack with increased heart rate ...lasted about 20 minutes after taking one half of a cyclobenzaprine and full glass of waterand deep breathing; had another evening of March 10. much shorter duration.. After second shot, day after slight headache and bone tired...tiredness continues to present and my head feels like is has a vise or a helmet on it. Also have developed a kind of dermatitus but don't know for sure if I had it before and didn't realize it. I just want to sit down or lie down...My leg/butt muscles feel not up to the job...and in general thru today I just feel "off". Some days better than others.

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.

fever, low blood pressure, high heart rate, anemia, fluid on lungs. hospitalized 2/19-2/23, 2/26-3/1, and 3/15-current

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.

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.

Patient daughter told clinic team her mother was not feeling well after receiving vaccine. Daughter also states patient was lightheaded and unbalanced prior to receiving vaccine. After receiving vaccine, patient became diaphoretic, light headed, BP 110/82. States her blood sugar was normal at breakfast, but could not remember #. Daughter states patient showing signs of confusion. Gave patient soda in case BS related. Decision was made to take patient to ED for further evaluation of DM vs. reaction to CoVID vaccine.

pneumonia; She is coming up on 60 days now; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 76-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, at the age of 76-year-old, on Jan2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was due to get the second dose on 18Feb2021 but was in the hospital with pneumonia and was unable to get the second dose. She is coming up on 60 days now. Outcome was unknown. Information about lot/ batch number has been requested

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

1st dose, none Second dose administered 02/18/2021, 11:00 AM 1st 10 days: lymph node swelling of left breast and later, right breast, First evening required a hot pack to reduce pain. Left shoulder was rehabbed from torn rotator cuff over a year ago, now joint pain for 3 weeks, varying in severity Brain fog, fatigue, irritability 3 1/2 weeks Changes in taste but not smell, last 7 days, continuing today 03/29/2021

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

she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was feeling sick; fall; bladder issue; sinuses; body aches; she was miserable; this was painful than the other shots she has taken; Chills; she was worn out/She was tired; nausea; Malaise/feeling sick; her "armpit" hurting; muscle and joint pain; muscle and joint pain; headache; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: EL3247, via an unspecified route of administration, administered in left arm on 10Feb2021 as single dose for COVID-19 immunisation. Medical history included multiple sclerosis, Chronic obstructive pulmonary disease (COPD), overactive bladder, osteoporosis, sinus headache, allergies also bother her, back issues, and broken femurs from 2019. Concomitant medications were not reported. The patient received her first dose of the Pfizer COVID vaccine on 10Feb2021 and is due for the second dose tomorrow. The patient stated that she has really heavy reaction from the first dose, she felt like she was dying, fall, bladder issue, had headache, nausea, sinuses, body aches, muscle and joint pain, she was miserable, her "armpit" hurting, this was painful than the other shots she has taken. The patient wanted to know if its ok to take her nebulizer and other pain medications she is taking generic for Norco. The patient clarified that she had headaches, feelings with her muscles and joint, nausea, and then there was the big symptoms that hit her, she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was feeling sick. She herself didn't know what was wrong and so she couldn't go to the ER, she doesn't know what this is, it lasted 24 or more hours. The patient stated that it was the malaise, she's never had malaise before, it scared her. She is getting the second dose tomorrow and she is scared to death. The headache, muscle and joint pain and armpit hurting started 10Feb2021 while nausea and malaise/feeling sick started on 11Feb2021. The patient recovered from the event armpit hurting and malaise/feeling sick on an unspecified date. The outcome of the event headache, muscle and joint pain, was not recovered. The outcome of other events was unknown.

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.

Diarrhea; Heart palpitation; occasional low pulse rate; sore joints; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection), first dose on 14Jan2021 at 12:45 (lot number: EL0140 and expiration date was unknown) and second dose on 04Feb2021 at 12:45 (Lot Number: EL3302 and expiration date was unknown) both administered in Left Arm via an unspecified route of administration at a single dose for COVID-19 immunization. Medical history included diabetes, CAD (coronary artery disease), aortic stenosis, COPD (chronic obstructive pulmonary disease), arthritis. Concomitant medication was not reported. The patient was not received other vaccines within four weeks of vaccination. The patient received unspecified medications within two weeks of vaccination. On 05Feb2021, the patient experienced diarrhea, heart palpitation, occasional low pulse rate, sore joints, and low-grade fever. The patient not received treatment for the events. The patient not had covid prior to vaccination. The patient not tested for covid post vaccination. The outcome of all events was reported as not recovered.

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.

headache; This is a spontaneous report from a contactable consumer (patient). This 76-year-old female consumer (patient herself) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3246) via an unspecified route in Left arm on 16Jan2021 being 02:34 PM (at the age of 76-years-old) as single dose for COVID-19 immunisation. Relevant medical history and concurrent conditions included Blood pressure high started on 2009, Glaucoma, she had a car accident in 2009 where she got hit from behind that caused issues with her neck and she has this in her right eye, and her doctor put her on a new eyedrop in November, but other than that her meds stayed the same. Concomitant medications were not reported. Patient stated that her husband and her took the first dose of the vaccine on Saturday 16Jan2021. She says she was fine Saturday, then she woke up on Sunday morning with a headache behind her eyes that was not bad but she noticed it most of the day and then at night it was behind her eyes, the top of her head, and behind her head on 17Mar2021 at 07:00. She says she has had headaches all last week, and she took Advil and Tylenol which sometimes helped. She says she finally saw her doctor last Friday on the 22nd because she felt that was a long time for her to have headaches as a result of a vaccine and her doctor had her do a CAT scan to be sure, since she is 76, to check if she might be having a stroke or something. She says she has continued to have headaches, though not as bad as last week, and she was reading the material they got at the hospital because they are supposed to have the second shot 06Feb2021. She says she would like to know, have they had people report having headaches that long. She says she took both Tylenol, clarified to being Equate brand Acetaminophen, and Advil. Equate brand Ibuprofen 200mg: She says she normally doesn't take Advil. Equate brand Acetaminophen: She says she has two bottles one of which she keeps in the bedroom, so she doesn't know which bottle her doses came from. She says both of the Equate brand Acetaminophen bottles are extra strength, 500mg. She says when she took these two medications she was careful not to overtake or take too much, but she can't really tell how much she took. She says she thinks she first took one Tylenol and one Advil, then later that night when it really bothered her, she thinks she took maybe two Advil's and one Tylenol, but she didn't write it down. She says now her headache is not nearly like it was last week. She says that she spoke to her doctor on Friday because she was starting to get concerned about it, but it was not unbearable all day long, she would wake up with it then take something, and during the day it was better, then at night it would be worse. She says this week it mainly bothered her that it was at the back of her head and neck area, since she does have problems sometimes with headaches at the back of her head after she had a car accident in 2009 where she got hit from behind that caused issues with her neck. She says she doesn't have sinus issues, so the headache behind her eyes was odd, and since the information said side effect, it is too big of a coincidence that she got the shot Saturday and she had a headache on Sunday. probably in 2009, and she started taking Amlodipine 5mg then, and then after she retired from teaching her doctor decided she didn't need it and she stopped taking it. She says she has been taking again since about a year and a half ago, in 2018 at the end of the year. Amlodipine NDC/LOT/EXP: Unknown, it was dispensed in a pharmacy bottle, it says use before 14Nov2021. Laboratory tests included CT scan resulted negative on 22Jan2021. The outcome of the event was recovering.

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.

Bad headache on left side of head Teeth started chattering for 2 minutes, but didn't feel cold 100.4° fever Legs felt 'heavy'

Faint; Fever; Dizzy; Diarrhea; 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, administered in right arm on 20Mar2021 12:00 (Lot Number: EP7534) as single dose for covid-19 immunization at age 76 years old. Not pregnant at the time of vaccination. The patient medical history was not reported. No allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included lisinopril; amlodipine besylate; and carvedilol; all taken for product used for unknown indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 administered in right arm on 26Feb2021 12:00 PM (lot no: EN6202) for COVID-19 immunization at age 76 years old. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 21Mar2021, the patient experienced faint, fever, dizzy, and diarrhea. The events were reported as non-serious. No treatment received for the adverse events. The patient had not recovered from the events.

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.

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.

10 days and about 10 hours following my second vaccine, I experienced significant headache, body aches and fever (that was initially, 100.8 and peaked the following night at 101.6 F.). This morning (about 30 hours from the first appearance of symptoms, all symptoms had abated).

Last injection Jan. 28th. On March 15 I started with sore throat and my husband seemed to have head cold. On Tues. his job told him to get a COVID test. He went in Wed. and the rapid test was positive. I went down hill. I had headache, chills, sore all over, sore throat, coughing, shortness of breath, sore tongue, diarrhea, didn't have fever. Was up Thursday night because of shortness of breath. Called Doctors office and was told to go to walk in clinic and someone would come out and get me. Was seen by PA I think. Not a doctor. They only did a rapid test and it was negative. She didn't do the second test and send it off. I have found two people who had the rapid rest and results were negative that the results s Results sent in from second test came back positive. She prescribed Prednisone which helped. I was sick for over two weeks and still struggling with fatigue, aching , sore throat and shortness of breath.

impacted stool; Impacted bowel movement; She actually tore and was bleeding really bad; exhausted; she had arrhythmia episode; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 76-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date: 30Jun2021), via an unspecified route of administration, in Arm Left, on 09Mar2021 at 01:30 PM, as a single dose for COVID-19 immunization, at hospital and administered by a Nurse. Patient's medical history was not reported. Concomitant medications included rosuvastatin calcium, at 10 mg, 3x/day, (three days a week) and then at 5 mg, 4x/day, (5 mg four days a week); levothyroxine (50 ug) for Thyroid disorder and amlodipine besylate (2.5 mg) and had been taking fiber and probiotics. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Lot number; EN5318, expiry date; 31May2021, Received in right arm) for COVID-19 immunization; Had no problem with first COVID-19 Vaccine. No pain at site, nothing. Patient stated that she had arrhythmia episode and that was unusual for me; Since then I have had four more episodes in Mar2021. Patient stated that her second dose of the vaccine at 1:30 pm. The same day at 10 pm, she experienced an impacted stool. She stated that she was on the toilet from 10 pm-12:15. She wanted to know if this is a reported side effect of the vaccine. After receiving second dose, patient stayed 30 minutes and felt fine. At 10 PM felt that need to go to the bathroom, which she thought was odd. More than two hours she tried to pass a BM. It was so impacted she could feel it all around her anus. Was ready to go to the hospital. Didn't know what to do. Waited and waited sitting on the toilet. Was trying to see if she could dig anything out and it was non-productive. At 12:15 AM bowel movement finally left. It was 13 inches long and 3 inches around. She actually tore and was bleeding really bad. She usually drinks a lot of water, but was not able to the day of the second COVID-19 Vaccine. It was stated that total time of bowel movement impaction was two hours and 15minutes (Began 10PM on 09Mar2021 and passed at 12:15AM on 10Mar2021). She was not supposed to push with bowel movement impactions. Patient was told by Doctor, patient could get a heart attack or stroke from pushing impacted bowel movements. Patient was so exhausted and a very bad experience. No further details provided. Had a lot of vaccinations over the time due to living in Honduras for 2 years and traveling in Brazil. No further details provided. Scheduled mammogram fourth months from second dose. Patient did not receive other vaccines within 4 weeks or prior vaccination. She had a colonoscopy 6-8 months before the vaccine and had been taking fiber and probiotics. Outcome of the events impacted stool and Impacted bowel movement was recovered on 10Mar2021; for all other events it was unknown. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.

For 3 days after I was so tired it was hard to get off couch. My Afib has been controlled but the afternoon of shot heart rate started to fluxuate. had appt with heart Dr. took EKG was ok but stated that there were several patients with same systems. by Thursday April 1st, heart rate was up to 143, called 911, by the time I got to ER it was going down. Had another EKG with in range and all other blood work was OK. Right ankle that swells because of arthritis swelling is now worse.

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.

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.

FEELING VERY SICK. Pain is unbearable. arm is sore. Fast pulse. when I get up I feel like I am going to faint. Chills low fever, Pain in joints and muscles severe headache.

03/29/21 - severe headaches started and continued 04/03/21 - balanced/dizziness/vertigo feeling started and continued 04/04/21 - admitted to ICU and diagnosed with Hemorrhagic Stroke

chills; Bad Headache; This is a spontaneous report from a contactable consumer(patient). A 76-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809 and Expiration Date: UNKNOWN), via unspecified route of administration in left arm on an 13Feb2021 09:45(at the age of 76-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. Patient relevant medical history included, Sulfa Allergy, drug allergy (Amoxicillin). Other medical history reported as very good health. The patient was not diagnosed with COVID-19 prior to vaccination. Patient concomitant medications included in two weeks alendronate sodium (FOSAMAX) (MANUFACTURER UNKNOWN) on 15Feb, simvastatin (MANUFACTURER UNKNOWN), levothyroxine sodium (MANUFACTURER UNKNOWN). Headache and chills since 16Feb Take Advil every 6 hours to mitigate reaction. Was fine day after shot, Took Fosamax on 15Feb and chills and fatigue set in that PM. On 15Feb2021 at 19:00 the patient experienced bad Headache and chills. Headaches started on 16Feb and continue. Since 16Feb2021 patient took Advil every 6 hours to mitigate reaction. On 20Feb2021, Nasal Swab COVID test was performed post vaccination included, negative result. The outcome of the event was reported as not recovered.

headache; feeling sick in her stomach.; Nausea; This is a spontaneous report from a contactable female consumer reported for herself. A 76-year-old female patient received her 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) at single dose on 13Feb2021 13:50 via an unknown route in left arm for Covid-19 immunization. Medical history and concomitant drug were not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EL0142) on 23Jan2021 at 13:30 injection to left arm for Covid-19 immunization and reported that she did not have any problems with the first dose of the Pfizer-BioNTech COVID-19 Vaccine except for her arm was really sore and heavy the next day (on 24Jan2021 13:50) which lasted about 2-3 days until she recovered completely from event, and flu shot around Sep2020 for immunization. She initially described event as arm was really sore and heavy with Pfizer-BioNTech COVID-19 Vaccine as being sore the next day like a flu shot where arm was really sore and heavy, but also reported that she had no history of adverse events or reactions to prior vaccinations. No vaccines administered on same date with the Pfizer vaccine considered as suspect. Family Medical History Relevant to events was none. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient experienced headaches and nausea on 15Feb2021, approximately 2 days after second dose administered. She reported headache lasting more than 7 days. The clinical course was reported as follows: Having headaches off and on, had not been a constant day and night thing. It kind of comes and goes. The past weekend (as of 15Mar2021), on 14Mar2021 it was really bothering her. She took a Tylenol on 14Mar2021 after she got back from church and last night took 2 Benadryl and that seemed to help. That was the first time she has taken Tylenol for events. She had just been letting headache wear itself out. Regarding nausea, it was further described as sick to her stomach. Outcome of Headaches was not resolved. Seriousness for headaches was unspecified. No visit to Emergency Room/Physician Office required, not hospitalized. Outcome of the events was not resolved. Follow-up attempts are completed. No further information is expected. Follow-Up (13Apr2021): Follow-up attempts are completed. No further information is expected.

BODY ACHES; FEVER; NASTY TASTE; dark urine; backache; heartburn; fatigue; This is a spontaneous report received from a contactable consumer(patient). A 75-years-old female received second dose of BNT162B2 (BNT162B2, formulation: solution for injection, lot no: EL9267), via an unspecified route of administration in Arm Right as SINGLE DOSE for covid-19 immunisation on 12-FEB-2021. Medical history included Diabetes mellitus from an unknown date in 2002 and unknown if ongoing, gastroesophageal reflux disease from 2010 and unknown if ongoing, Gall bladder reflux surgery and blood cholesterol from 2014. Concomitant medication included farxiga (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) 10mg from 2018, esomeprazole sodium (ESOMEPRAZOLE SODIUM) 40 mg, Januvia (SITAGLIPTIN) 100 mg, montelukast (MONTELUKAST)-10 mg, atorvastatin calcium (ATORVASTATIN CALCIUM) 80 mg, hydrochlorothiazide(HYDROCHLOROTHIAZIDE) 12.5 mg. All the drugs are ongoing.On 13Feb2021, patient experienced body aches, fever, nasty taste, dark urine, backache, heartburn, fatigue. There was no treatment due to events. The outcome of events were recovered. No follow-up attempts are needed. No further information is expected.

Pt reports feeling a little tired; This is a spontaneous report received from a spontaneous Program. A contactable other healthcare professional and a consumer (patient) reported that a 76-year-old female patient received COVID-19 vaccine (UNSPECIFIED TRADE NAME), dose 2 via an unspecified route of administration on 17Mar2021 (Lot number was not reported) at single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ), via an unspecified route of administration from 10Jan2021, at 5 mg tablet, cyclic for an unspecified indication. The patient previously received the first dose of COVID-19 vaccine on an unspecified date for covid-19 immunization. Patient reported a 1 week pause in tofacitinib citrate treatment as advised after her 2nd COVID vaccine on 17Mar2021. Patient reported feeling "a little tired", but could not be sure if from tofacitinib citrate or recent move back form winter home. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

On 2/16, a few hours after the second shot, I started to feel exhausted. For 2 days I slept about 17 hours total. When I got up, I coughed nonstop and wheezed. Codeine cough syrup did nothing. On Mar 5, I was no better, so I went to Urgent Care. They said I had an exacerbation of COPD, but I have never had COPD. They prescribed erythromycin, prednisone, and a Wixela inhaler. On Mar 15, my PCP, Dr. put me back on prednisone for 10 days and added 2 OTC asthma meds. Within 10 days I was much better. On Apr 5, I had some breathing tests that were normal. I saw pulmonologist Dr. on 4/16. He said it might have been a vaccine reaction. I have never experienced anything like this before.

Feeling cold, headache,cough, extreme tiredness Took ASEA cell stimulating molecules, 1 Tylenol, slept 10 hours and was fine

Mild headaches that started the afternoon of the second vaccine. I took tylenol the first few afternoons, but discontinued daytime use and took the tylenol every night at bedtime. Headache is not continuous, but does occur for several hours at sometime during the day.

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.

Headaches, getting worse.; getting worse; This is a spontaneous report from a contactable consumer. A 76-year-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 14:00 (Batch/Lot Number: EL5318) at single dose for covid-19 immunisation. Medical history included bradycardia and overweight. Concomitant medication(s) included amlodipine; hydrochlorothiazide; rosuvastatin and potassium chloride. The patient experienced headaches, getting worse on 15Feb2021. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of the events was not recovered. No follow-up attempts are possible; No further information is expected.

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.

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.

Extreme pain, went to ER and morphine didn't do anything so they gave me something stronger than morphine. Was released and sent home to which the pain got so bad when the med wore off that the following morning I was in the ER again. I also had a fever of 102.3 and a rash (red bumps all over my chest, stomach, back of neck and shoulder back area, nausea, chills. this lasted exactly for 5 days and then was gone.

This 76 year old female received the Covid shot on 2/27/2021 and went to the ED on 4/13/2021 and was admitted on 4/13/2021 with hortness of breath, abnormal lab, and returned to ED on 4/16/2021 and admitted on 4/17/2021 with vomiting, elevated troponin, dehydration and returned on 4/23/2021 and admitted on 4/24/2021 with rapid heart rate and acute respiratory failure and died on 4/24/2021. 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.

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.

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.

No adverse event, but patient and her husband (both fully immunized) tested positive for COVID19 on 4/24/2021. Patient's symptoms started April 14 (cough only)

Headache; Shrunk; Weight gain; Not feeling that great; Dizziness; Felt weird when went for walk; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3249, expiration date: 31May2021) via unknown route of administration in right upper arm on 21Jan2021 at 11:00, at a dose of 0.3mL as a single dose for Covid-19 immunization in Hospital and received new refill of Mycophenolate mofetil, which is an immunosuppressant at a dose of 250mg, 2 capsules by mouth two times daily for focal segmental glomerulosclerosis on the same day (21Jan2021). Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes and obesity), kidney problem and focal segmental glomerulosclerosis. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021, the patient experienced the dizziness, that started 10 days after the first dose of the vaccine and on the new refill of Mycophenolate mofetil and patient felt weird when she went for walk. On 01Feb2021, the patient was not feeling that great. Last Saturday (30Jan2021) and again today she felt some dizziness, felt weird, but did not think it can be blamed on the vaccine, or did that happen. She enquired whether that could also interact with the vaccine and had zero reactions until last Saturday. So, she wanted to check with Pfizer first and then with her kidney doctor. At that time, she was dizzy and could not shake it all that morning lone. Patient was on Mycophenolate mofetil for 2-3 years and it was a refill she just started on. With the timing right then with the dizziness wonders if related to the new batch she started that day. Unable to provide the NDC, Lot, or expiry for the Mycophenolate mofetil, but provided a discard date of 19Jan2022 from the white manufacture bottle and mentions (name) label over bottle. Mentioned that she does not take product as read on bottle it has been changed after discussion with the provider. Was using this prescription 2 in the morning and 1 at night and since she has been having the dizziness, she has switched to taking it 1 in the morning and 2 at night. Did read on the instructions that this can cause dizziness, but she had taken this stuff for over 3 years and was trying to figure out if it's a bad batch or not. On an unspecified date, the patient experienced headache and thinks she was shrunk and may have gained some weight. The outcome for the events dizziness, felt weird when went for walk, not feeling that great was not recovered and for headache, was shrunk and may have gained some weight was unknown. Information about lot/batch number has been requested.

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.

she was gagging and coughing; started to spin; Her throat was so swollen and it felt like she was choking; Her uvula was so swollen that is why she felt like she was choking; choking; severe throwing up; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0158) via an unspecified route of administration in right shoulder (Deltoid Right) on 11Apr2021 in the afternoon around 14:00 or 14:30 (at 76-year-old) at single dose for COVID-19 immunization. The patient's medical history was not reported. None history of all previous immunization with BNT162B2 considered as suspect. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for sinus disorder for years as needed. She took it the day before the COVID19 injection. She hasn't taken it since before getting COVID19 injection. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. She didn't have the ones on the paper. They didn't say she would have severe throwing up she almost had to call. She was choking on 12Apr2021. She was over it currently. She first threw up on Sunday evening and then was ok. On Sunday (11Apr2021 21:00) she only threw up once, but it was four intervals. Caller clarified an interval was where she would throw up then clean up and then throw up again. Then it was fine. On Monday (12Apr2021), in the evening around 9 PM she started to spin. She went to the bathroom and she was heaving and she couldn't say how many times she threw up. Her throat was so swollen and it felt like she was choking. Her throat was very raw. Her uvula was so swollen that is why she felt like she was choking. She was about to go the emergency room, but then looked it up. She did treatment that she saw online for 3 days. When she was gagging and coughing she looked up COVID19 Vaccine and it said that her throat would be swollen from severe throwing up. It made a lot of sense. She had all the symptoms listed online and it said it would get better in five days and if not seek treatment. It has gotten better. No visit for ER and Physician Office. Treatment received for all events. The outcomes of the events were resolving.

March 10, 2021 I received my second dose of the Pfizer vaccine and the following day I experienced the predicted side effects of fever, chills, headache, fatigue and lack of appetite, which were all mild and I took Tylenol for the fever. The following day I was fine. After approximately two weeks I noticed there were subtle and unusual changes regarding my appetite, energy level an itchy rash on my back and a runny nose. I didn?t pay much attention to any of these as they weren?t debilitating symptoms, but very unique for me. Then I realized I needed to pay more attention to these symptoms as they were getting more significant, except for the fact I didn?t have a fever. Also my ears felt they were blocked. I thought perhaps because of the feeling of blocked ears I may be getting a sinus infection although I haven?t had one in years. I called the doctor?s office on April 5th and I was told to go to the Urgent Care, which I did. I was examined and given a prescription for a nasal spray, antihistamine and an antibiotic in case symptoms became more severe. It was also suggested that I may want to have a Covid test. I?m not used to taking any medications except for Trazodone, and was reluctant to take what was prescribed because if it was indeed a sinus infection it wasn?t in line with any I?d had years ago. I used the nasal spray for a few days and also the antihistamine. The headache got worse, and would move from one area of my head to another and also down the side of my face and neck. Tylenol didn?t help and Ibuprofen only helped now and again. The headache had a mind of its own. Warm compresses did help. I was in contact through the portal for recommendations from the medical staff.

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.

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.

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.

Dizziness and sleepy. At 1314: BP 174/88, HR 50, O2 95%. Observed 15 minutes and pt drank water. At 1338: BP 155/77, HR 54, O2 96%. Pt stated feeling better and had steady stable gait. Advised to seek ED if sx worsen. Stable and released.

Chills for 5 hours, Fever 100.9, Headache, Achy body, Nausea. Still had fever of 99.0 24 hours later. This same thing happened with the 1st shot, but not as intense and as long as this 2nd shot.

She had no pain from the initial shot but then that night she stated she felt horrible, aches and pains and her cough worsened. a week later she said that the symptoms were just as bad, she was extremely tired also. Nauseated as well. She did not believe that she had a fever.

tinnitus; joint pain; headache; extreme fatigue; chills; then fever; 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 mRNA VACCINE, Solution for injection, Lot number: EL9266), via an unspecified route of administration in left arm on 26Feb2021 at 07:15 AM as single dose for COVID-19 immunization. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 05Feb2021 at 07:00 AM at single dose for COVID-19 immunization. Medical history included high blood pressure, arthritis. Patient had known allergies. Concomitant medications included lisinopril, calcium, ergocalciferol (VITAMIN D[ERGOCALCIFEROL]), naproxen sodium (ALEVE). The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. On 26Feb2021 at 08:00 PM, patient experienced headache, extreme fatigue, tinnitus, chills, joint pain, then fever. No treatment was received. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

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.

injection site became red swollen and firm and warm within 24 hours of injection; injection site became red swollen and firm and warm within 24 hours of injection; injection site became red swollen and firm and warm within 24 hours of injection; chills; nausea; diarrhea; site remains red swollen and little soreness area below injection site.; This is a spontaneous report from a contactable consumer. A 76-year-old female patient (non-pregnant) received second dose of BNT162B2 (BNT162B2, PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 13:15 as 2nd dose, single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as first dose in left arm (Lot number: EL3302) at 1.00pm on 20Jan2021 for COVID-19 Immunisation. COVID was not found prior vaccination. Medical history included hypertension. The patient's concomitant medications were not reported. Other medications were received in two weeks but not specified. The patient experienced injection site became red swollen and firm and warm within 24 hours of injection, chills, nausea, diarrhea and site remains red swollen and little soreness area below injection site. Treatment was not received. The outcome of the events was recovering for chills, nausea and diarrhea whereas not recovered for the other events.

Cough pt states that she has had a cough x 3 days with congestion. pt states that she got her 1st COVID shot 2/6/2021

1/2 hr after receiving dose my throat and tongue swelled up; 1/2 hr after receiving dose my throat and tongue swelled up; My chest started bothering me and I was short of brreathe.; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, in right arm on 08Mar2021 10:30 as first dose single for covid-19 immunisation. Medical history included known allergies to various chemicals, foods, red dyes, high blood pressure and AFIB. Concomitant medications included hydrochlorothiazide, lisinopril, apixaban (ELIQUIS), montelukast, duloxetine and metoprolol tartrate all are taken for an unspecified indication, start and stop date were not reported. 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. Patient reports a half hour after she left the facility, she started getting a sore throat, then her throat and tongue swelled up. A little later my chest started bothering me and patient was short of breath on 08Mar2021 11:00 AM. Patient states she is getting better very slowly. This lasted all night and started to ease up the next day. patient took some Benadryl and that helped. As per the reporter seriousness criteria reported as medically significant. Patient received treatment that patient took of Benadryl and she has an inhaler. The outcome of the events was recovering. Follow up needed and additional information has been requested.

Runny nose, cough, post-nasal drainage, sneezing, itchy/watery eyes Alka-seltzer plus hot caramel tea with honey

Systolic pressure for five days up to 220 - Added extra blood pressure medicine in the middle of the day. That kept the systolic pressure slightly under 160. Diastolic pressure was never over 75. Symptoms were sweating, heart pounding, headache, and fatigue.. Resolved itself on May 16, 2021 at approximately 6 p.m. when blood pressure again registered 125/74.

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.

Cough Fever, unspecified fever cause Loss of taste Loss of smell Nasal congestion Acute nonintractable headache, unspecified headache type

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.

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.

chills; body aches; This is a spontaneous report from a contactable other HCP. This Other HCP reported that a 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, Expiration date not reported), via an unspecified route of administration on 11May2021 as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history included pre-existing condition of mouth ulceration from an unknown date. The patient's concomitant medication included palbociclib (IBRANCE, 125mg,) taken orally from 31Mar2021 as daily dose (day 1-21 of 28 day cycle) for breast cancer and is ongoing. The patient experienced chills and body aches on an unspecified date. The outcome of both the events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Hint aches throughout body; very fatigued; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 12:30 (at 76 years old) (Batch/Lot Number: EN6201) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 16Feb2021, patient experienced Hint aches throughout body and very fatigued. No treatment for the events. The outcome of the events was not recovered. No other vaccine_in_four weeks. No covid_prior_vaccination. Not covid tested post vaccination.

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.

This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration on 30Jan2021 09:30 (at the age of 76-years) as 2nd dose, single dose in left buttocks for covid-19 immunization. Medical history included: slight high blood pressure and unspecified allergies. The patient didnot receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included carvedilol 12.5 mg, vitamin d [vitamin d nos], pantoprazole sodium. The patient received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration on 09Jan2021 at 10:30 as 1st dose, single dose in Left buttocks for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 31Jan2021 at 05:00, the patient experienced fever 102.6, chills and aches, headache, soreness at site of injection with a 3 inch red circle. The patient underwent lab tests and procedures which included body temperature: 102.6 on 31Jan2021. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.

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.

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.

This is a spontaneous report from a contactable consumer or other non-HCP. A seventy-six-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809) (At the age of seventy-six-years-old) via an unspecified route of administration, administered in left arm on 13Feb2021 at 09:45 as 1ST DOSE, SINGLE for COVID-19 Immunization. Patient did not receive any other vaccine in four weeks. Patient did not experience COVID-19 Infection prior vaccination. The patient medical history Includes known allergies: Sulfa drugs, Amoxicillin. Concomitant medications included Simvastatin, Levothyroxine Sodium and Alendronate Sodium taken for an unspecified indication, start and stop date were not reported. On 16, Feb2021 at 05:00 PM, the patient experienced headache and chills developed 3rd day. severe headache for seven days, mild headache for four days She was worried about 2nd dose. The patient underwent lab tests and procedures which included Nasal swab and CVS swab post vaccination and showed negative Sars-Cov-2 test on 18, Feb2021. The outcome of the events was not recovered. No follow up attempts are possible. No further information is expected.

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.

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.

began with headache and chills during the night and the next day continued headache, chills, tired, loose stool decreased appetite. The second day after injection was better but not normal and the third, fourth, fifth, and sixth days were mainly headaches with minor chills. The most persistent event has been waking with headaches each morning. Goody's headache powder helped but then they returned. Sixth day just felt tired along with the headache. Normal appetite has not returned.

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.

This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 as 1 st dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient is a 76-year-old female patient who received her 1st dose of the COVID Vaccine a week ago today, 20May2021. She mentioned that she experienced basically every side effect on the fact sheet except nausea. She had fever, chills, injection site swelling. injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and a general feeling of unwellness. She mentioned that this lasted for 5 days and all came in gradually and not all at once. She is better now as of calling. She was asking if this is to be expected with the 2nd dose as well. The patient enquired whether using a heating pad would affect the effectiveness of the vaccine. The outcome of the events fever, chills, injection site swelling, injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and general feeling of unwellness were recovered. Information on the lot/batch number has been requested.

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.

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.

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.

Medic responded emergency reference allergic reaction at vaccine clinic Medic to find 76/f seated in drivers seat, c/o nausea immediately after receiving vaccine. EMS standby staff on scene. Pt stated she had received vaccine approx 30 minutes prior to EMS arrival and began to feel ill <15 minutes later at which time standby EMS crew were alerted and in turn alerted transport. Pt has extensive list of allergies, including many antibiotics. Pt was A&OX4, pink warm and dry w/ good ABCs/PMS upon EMS arrival. Pt had no apparent life threats/injuries, was PEARL, equal lung sounds. Upon being placed in ambulance pt began to complain of dull ex pressure 2/10. 3 lead displayed sinus rhythm w/ PVCs which pt stated was her normal per pt cardiologist and that she was medicated for same with herbal medication.12 lead obtained, no elevation or depression noted, PVCs still noted, otherwise unremarkable. R-IV access attempted x2, good flash vein blew. 3 and 12 lead obtained to rule out cardiac involvement and monitor for changes. Given reference pt statement of positive ex pressure. Zofran considered, Medic was already at hospital when last IV was unsuccessful, PO zofran not given. No further interventions. Pt moved to stairchair via stand and pivot with assistance, secured via straps and moved to stretcher, pt placed in stretcher via stand and pivot with assitance, covered for comfort, secured via straps/siderails and moved to ambulance without incident. Pt and pt vitals monitored for duration of routine transport. Pt report called for prior to arrival. Upon arrival pt offloaded and moved to bed in ER via sheet draw without assistance. Pt care report given and pt care transferred to ER RN. Medic checked back in service. 76-year-old presenting with nausea and general malaise. Symptoms started about 15 minutes after receiving her COVID-19 vaccine around 2:30 PM. She has been nauseous but had no vomiting. Slight central chest discomfort with palpitations. Also feeling somewhat dizzy. She did not receive any medications. EMS was called and brought her to the ED. Denies any itchy skin, abdominal discomfort, sensation of throat swelling or pain. No wheezing or difficulty breathing. She has had anaphylaxis to medications in the past but she is unsure exactly which ones except for codeine. 76-year-old presenting with possible reaction to the Pfizer COVID-19 vaccine. Constellation of symptoms are not consistent with anaphylaxis but may represent a different type of allergic reaction. Will give Zofran for nausea, Benadryl, and observe. Basic labs and EKG. KG My interpretation of EKG Normal sinus rhythm. Normal axis and intervals. No acute ST elevations or depressions. Reexamination/Reevaluation Patient was observed for over an hour without any progression of symptoms. Her nausea improved with Zofran. No episodes of vomiting in the ED. Discharged with plan to follow-up with her PCP, continue symptom management at home. Diagnosis/Disposition Nausea without vomiting atient Instructions Continue your regular medications as prescribed. Use Zofran 4 mg every 8 hours as needed for nausea. Follow-up with your doctor within the next 1 to 2 days for recheck. Return to the ED if you develop severe difficulty breathing, severe chest pain, intractable nausea and vomiting or have other concerns. RX Given ondansetron: 1 tab, PO/SL, TID, nausea/vomiting, # 10 tab, 0 Refil(s)

she experienced dizziness; dry cough; Headache; Sneezing; No taste; Nausea; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported), age at vaccination of 76-years-old, as single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. Between the first shot (28Jan2021) and the second shot (on 18Feb2021), the patient experienced dizziness, dry cough, headache, sneezing, no taste, nausea, and was very tired/ extremely tired. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Major Fatigue & flu-like symptoms since 4 days following injection; Major Fatigue & flu-like symptoms since 4 days following injection; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 19Feb2021 12:45 (at the age of 76-year-old) as single dose for covid-19 immunisation. Medical history included fatigue from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced major fatigue and flu-like symptoms on 23Feb2021 with outcome of not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained

Burning sensation all over her skin; Very tired; 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 mRNA VACCINE, batch no: EN6205, NDC number; expiration date: unknown), via unspecified route in the deltoid left on 26Feb2021 at 15:00 as single dose for COVID-19 immunization. The patient medical history included blood pressure. Concomitant medication included atenolol taken for blood pressure as 25 mg, amlodipine as 2.5 mg and doxazosin as 1 mg, both taken for blood pressure measurement. Patient previously had first dose of BNT162b2 (Lot: EL9264, NDC; expiration date: unknown) on 05Feb2021 for COVID-19 immunization. On 27Feb2021, in the morning when she woke up, she had burning sensation all over her skin. She rested all day on the 27Feb2021 and then Sunday 28Feb2021 she was just a little tired but there was no more of the burning sensation. She confirmed the tiredness started on Saturday 27Feb2021. She usually works on Saturday, but she could not work because she was too tired. By Sunday 28Feb2021 she was better. She thought she rested and continued to rest because she was still a little tired. She recovered by Monday and she went back to work. The patient did not receive any treatment for the events. The clinical outcome for the event burning sensation was recovered on 28Feb2021 and very tired was recovered on 01Mar2021. No follow-up attempts are possible. No further information is expected.

Acute idiopathic Pericarditis with recent hx of new onset rapid atrial fib admitted from 5/18-5/21 thought to be a possible immune mediated side effect from her covid 19 vaccine .. since 5/9 she has been experiencing daily severe headaches, malaise, intermittent palpitations. Ct brain at that time neg for bleed but showed small/old b/l lacunar infarcts. cta was neg for pe/acute pathology. She was discharged out on amiodarone, metoprolol and eliquiss to follow up with cardiology.on follow up with him her amiodarone was dc'd and the plan was to see EP for possible cardioversion but She then was readmitted from 6/5 -6/8 with new pericardititis with new b/l pleural effusions, new chf and new cardiomyopathy. She c/o 2 days of sob, b/l shoulder pain, chest heaviness and pain, worsened while lying flat along with continued intermittent racing heart. cxr showed new Basilar predominant opacities in both lungs suggesting pulmonary edema and was admitted with new chf with bnp of 993. She was then noted to have an elevated wbc with left shift and a fever and her CRP was markedly elevated at 67. CT chest showing Nonspecific abnormalities including 1cm thick pericardial effusion, bilateral pleural effusions and mild right-sided ground-glass lung opacification. . She has had no recent infections, travel, cont meds, does not drink alcohol, smoke or use drugs or supplements covid 19 neg. She was started on colchicine 0.6mg bid and ibuprofen 600mg q8h on 6/6 and was discharged home to follow up again with cardiology. she has improvement in herwbc to normal, resolution of L shift, resolution of fever and only slight increased crp. She has also converted to sinus rhythm although still tachycardic around 110bpm. Her headache is gone and she is no longer vomiting. State echo done this am showing ef 55% and new hypokinesis of the basal inferior wall and a Small amount of pericardial effusion with out any doppler evidence of Tamponade She had an echo last month which was normal She was also started on antibiotics due to b/l effusions which were eventually stopped before discharge

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.

I was very tired and I experienced Chills like I've never felt before and I had a high fever. After I was admitted in the hospital I was diagnosed with cellulitis.

significant level of pain in the left hemisphere of the head/pain had gotten progressively worse; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EL9264), via an unspecified route of administration, administered in the left arm on 09Feb2021, 09:00 (at the age of 76 years old) as second dose, single dose for COVID-19 immunisation. Medical history included atrial fibrillation (reported as Afib) controlled by medication. The patient had no known allergies and was not pregnant by the time of the report. Concomitant medications included sotalol, rivaroxaban (XARELTO), rosuvastatin calcium (CRESTOR), montelukast sodium (SINGULAIR), loratadine (CLARITIN), and Aci (as reported). The patient previously received the first dose of BNT162B2 (Lot number: EL3302), administered in the left arm on 19Jan2021, 09:00 (at the age of 76 years old) for COVID-19 immunisation. Approximately five days after second shot (13Feb2021), the patient experienced significant level of pain in the left hemisphere the of head and reported that the pain had gotten progressively worse. The event resulted doctor or other healthcare professional office/clinic visit; she had seen a dentist, an ENT, and a primary physician. No signs of dental, sinus, or other problem, and the patient was being treated for neurological reaction. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Therapeutic measures were taken as a result of the event and included treatment with prednazone (as reported), then gabapentin, and currently carbamazepine. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.

Chills; Fever of 100 degrees; Soreness in shoulders; Soreness in neck; Mild stomach ache; Lingering tiredness; This is a spontaneous report from a contactable Consumer, the patient. A 76 years old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration through the right arm for COVID 19 immunisation on 06Mar2021 at 15:30 PM. The patient past drug history includes BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot no: EN6201) received through the right arm. The patient medical history includes Afib (Atrial fibrillation), diabetes and Age (Acute gastroenteritis). 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. The patient has not been tested for COVID 19 since the vaccination. On 07Mar2021 at 15:30 PM, The patient experienced chills, fever of 100 degrees, lingering tiredness, mild stomach ache, soreness in the neck, soreness in the shoulders. No treatment measures received for the adverse events. The clinical outcome of all events was recovered. No follow up attempts are needed. No further information is expected.

12 hrs after shot, sharp pain in r side of head, Same in heart. Could not sit up for 12 hrs, drank only cold water from caregiver.

Vaccinated with Pfizer 2/1/21 and 2/22/221. Symptom onset 6/8/21 - cough, runny nose and nasal congestion. - mild cold symptoms. Sample sent for genomic sequencing

Vaccinated with Pfizer 2/1/21 and 2/22/21. Symptom onset 6/8/21 with cough, runny nose and nasal congestion - mild cold symptoms. Sample sent for genomic sequencing.

Major nosebleed; Headache; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient reported for herself). A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown, Expiration Date: unknown), via an unspecified route of administered in Arm Left on 03Jun2021 08:00 (at the age of 46-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus Verbatim: Diabetic (She takes medication.Caller stated she probably was diagnosed 25 years ago. It's been a while), allergy (she took the shot because of her allergies), peripheral swelling (Her arm swelled up 3 times), compromised immune status, respiratory illness, genetic, chromosomal abnormalities, Endocrine abnormalities (endocrine abnormalities, including diabetes and obesity) from an unknown date and unknown if ongoing verbatim. The patient concomitant medications were not reported. The patient previously took epinephrine and experienced drug hypersensitivity. smallpox vaccine, vaccination Date: 1969. Her daughter was getting her smallpox vaccination at the same time. The caller had never had a smallpox vaccination. They decided to give it to her and her daughter at the same time. Her arm swelled all up again to the point her daughter took her to the emergency room. patient took Tetanus vaccine in 1996 and experienced allergy to vaccine, they told the caller she was allergic to the tetanus. She now wears a bracelet. Hopefully no one will give her a tetanus shot. Provide 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. Caller stated she probably was diagnosed 25 years ago. Caller stated she does take diabetic medication. Vaccination Facility Type caller stated the clinic is connected to the hospital. 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 COVID vaccine. Reporter stated, She had her first shot. She was advised to be near a hospital when she took the shot because of her allergic to the Epinephrine. she took the shot there. On 03Jun2021, patient experienced headache. she didn't had a headache before the shot. By noon, she was felt this headache. Caller stated she still has a little bit of it right above her left eye. the headache didn't go away with the Tylenol. The Tylenol doesn't seem to help much. She had to go buy some Tylenol. She had a major nosebleed on 05Jun2021 14:35 Saturday. Her headache kept getting worse. Reporter stated she did go to the physician office to get the packing removed from her nose. She went to the Emergency Room on Saturday. They had to cauterize her nose and packed it. She had no idea if it was from the shot or if the shot contributed to it. She hasn't had a nosebleed like that in years. It has been a long time since she had a bad nosebleed. She just wanted to let Pfizer know what's going on with her because it may help someone else. Her daughter was in healthcare and said caller should call and let Pfizer know. What good was it going to do to continue with the report. Reporter stated she still has a little bit headache on right above her left eye. It's not quite as bad as it was. It's there. She can tell it's there. Reporter stated she has no idea about dose. Caller stated she was not hospitalized. The outcome of the event major nosebleed was reported as recovered on 08Jun2021 and the headache was recovering. Description of complaint: Caller was reporting an AE to the Pfizer Covid Shot. Caller reports taking Tylenol for a headache and the headache did not go away. Caller reports the Tylenol doesn't seem to help much. Product strength and count size dispensed: Caller confirmed that it is 500 mg of Acetaminophen. She only took 2 like the instructions tell you. Count size is 60 tablets in the bottle. Packaging sealed and intact: absolutely. Information on the lot/batch number has been requested.

Within a few days, I had some joint pain, headaches and fatigue. I was also disoriented. Those symptoms lasted 1 week to 10 days. I took Tylenol. This is long term issue (happening before the vaccine): Thyroid- I was going through a series of tests that the doctor was doing. My diet was changed and the medications were changing. I called the doctor most recently about Pinworm- went to see grandchildren and got that from them. They prescribed me Pinworm Medicine - the active ingredient is - Pyrantel Pamoate. I started taking that on June 10th. That's helping with my symptoms. I have to wash everything all the time. I have to repeat the Pinworm medication on the 24th of June.

Breakout rash around neck, shoulders, chest, arms and tops of legs. None under arms or breasts. Has had rash since 6/7/21. Some raised bumps within rash as well, resembled insect bites. Some of the rash looked like insect bites, other areas skin broken, looks like skin scraped. Skin has peeled off on those areas. Had got bladder infection since then as well. Had blood in urine and received antibiotic (6/9/2021). Since then bladder infection has cleared. But patient has had a cough since then (about 5 days into breaking out). Has also had a slight headache.

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.

She has also has dizziness; She is pitching forward like vertigo; The dizziness got much worse this weekend; Memory issues; Confusion; Weakness in her legs; Pain in the back of her head, neck and above the ear and up to her skull; Pain in the back of her head, neck and above the ear and up to her skull; Pain in the back of her head, neck and above the ear and up to her skull; Nausea; Not feeling right, very tired; Not feeling right, very tired; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 27Jan2021 16:30 (Batch/Lot number was not reported) (at the age of 76-year-old) as single for covid-19 immunisation. The patient medical history included digestive system, blood thinner, acid, high blood pressure, diverticulitis she went into the hospital in 12Nov2020 or 13Nov2020 for an emergency for diverticulitis and then while she was there, she was sleeping and when she woke up, she had atrial fibrillation. They did the electric shock to get her heart back without sedation and that had an effect on her. Mentions she had another episode of atrial fibrillation about three years before, but it went back on its own. She was also diagnosed with diabetes mellitus at this hospitalization on an unknown date in 2020. Concomitant medications included famotidine for acid at 40mg twice a day via oral, lisinopril at 5 mg via oral for twice a day taken for high blood pressure, metformin at 500 mg daily via oral taken for diabetes mellitus, metoprolol at 25 mg daily via oral taken for blood pressure measurement, lactobacillus acidophilus (PROBIOTIC ACIDOPHILUS [LACTOBACILLUS ACIDOPHILUS]) daily (expiration date: Jul2022, Lot number: WHD204) for digestive system, rivaroxaban (XARELTO) since on an unknown date at 220 mg daily via oral taken for blood thinner. The vaccination facility was a medical centre. The vaccine was not administered at (name) facility. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the suspect product. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient states she just wanted to report an experience after the vaccine. On 27Jan2021 (Wednesday) she went to the place for vaccination. It went very smoothly, and she didn't feel anything. The patient mentioned that she thought maybe it was her medicine and stopped taking her over the counter probiotic. The patient had problems, so she stopped this a couple of days before for the over-the-counter probiotic she stopped. On an unspecified date, in hindsight she thought some of the effects she was experiencing might be related to the vaccine. She was not sure if she was allergic to her usual medications or not. On 28Jan2021, the patient reports she had a lot of nausea; and not feeling right as in very tired. She didn't connect it to the vaccine. She thought maybe it was her medicine and stopped taking her over the counter probiotic. On 31Jan2021, she reported that weakness in her legs, pain in the back of her head, neck and above the ear and up to her skull. On 01Feb2021, she had worst memory issues and confusion. On an unknown date, she stated that she had had a lot of trouble with confusion doing her check book and questioning things that she did not do usually, and she also has dizziness and feeling like pitching forward like vertigo. On an unspecified date, the patient reported dizziness got much worse this weekend. She was supposed to get the next dose on 17Feb2021. The patient visited physician office. The outcome of the events the dizziness got much worse this weekend, she is pitching forward like vertigo was unknown. The outcome of the events pain in the back of her head, neck and above the ear and up to her skull was resolving whereas other events was not resolved. Follow-up attempts are completed. No further information is expected.

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.

consumer reported that after first dose, she felt unwell; had headache; body pain during 3 days; This is a spontaneous report from a contactable consumer or other non hcp. The consumer reported about the first dose administered. A 76-year-old female patient received 1st Dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,solution for injection,Batch/Lot number was not reported ), via an unspecified route of administration on an unspecified date (Age at vaccination 76-year-old) as dose 1,single for covid-19 immunisation. Medical history included hypersensitivity. The patient's concomitant medication included unspecified profilactic medication. Reporter states during the call patient mentioned she had chronic allergy and prior to first dose administration she took profilactic medication as her physician recommended. On an unspecified date, during the call consumer reported that after first dose, she felt unwell, had headache and body pain during 3 days. She mentioned taking Tylenol for management symptoms subsequently to vaccination. Reporter wanted to know about whether she could change appointment hour for second dose administration. The outcome was resolved on an unspecified date. Information about lot/batch number has been requested.

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.

Chills; Muscle and joint aches; Joint aches; Upset stomach; Tired; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 20Mar2021 at 09:15 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Allergies to medications, food, or other products that included sulphur drugs. Concomitant medications included Tylenol started on unknown date within 2 weeks of vaccination for unknown indication. The patient previously taken first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the right arm on 27Feb2021 at 09:15 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received other vaccines within four weeks prior to the COVID-19 vaccine which are not specified. The patient experienced chills, muscle and joint aches, upset stomach and tiredness on 21Mar2021. The patient did not receive any treatment for events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events chills, muscle and joint aches, upset stomach and tiredness were not resolved. Information about lot/batch number cannot be obtained. No further information is expected.

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.

Fatigue; This is a spontaneous report from a Pfizer sponsored program regulatory authority support via contactable consumer (patient) and contactable physician A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06Apr2021 as a single dose (at the age of 76-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 28Apr2021 as a single dose at the age of 76-year-old for covid-19 immunisation. Medical history included ongoing breast cancer. Concomitant medication included tamoxifen taken for breast cancer from an unspecified start date and ongoing. The patient states that both of her vaccines went very smoothly, and she only had some minor side effects, which includes fatigue. The patients antibodies test is negative and wanted to know if she can do another test to check the antibodies. Also wanted to know what she can or cant do there after the vaccination. The outcome of the event was unknown. Information about batch/Lot number has been requested.

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.

My reaction to Pfizer #2 lasted for 8 weeks and went through three phases. Throughout this time, I had swollen glands under my jaw. 1)The morning after the shot I awoke to severe nausea and vomiting and had to get prescription anti-nausea meds. 2) A few days later my bowels went wild with lots of rumbling and gas and frequent bowel movements. 3) The swollen glands in my jaw cycled between getting better and then worse, and I had and bouts of feeling unwell and fatigued. I went from sleeping 7-8 hours per night before the vaccine to sleeping 9-10 hours a night. Some days I was fine. Then I would have a bad day. One day I was fine in the morning then crashed after noon -- like when I had mononucleosis at 17.

I had slight rise in blood pressure and pulse; I had slight rise in blood pressure and pulse; felt tired; 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, Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Right on 31Jan2021 16:00 as (At the age of 76-years) DOSE 1, SINGLE for COVID-19 immunisation. Medical history included blood pressure abnormal, patient Was on blood pressure medication for many years. After losing 20 pounds did not need it anymore, blood cholesterol abnormal from an unknown date and unknown if ongoing Take Crestor 10 mg for cholesterol (total around160). Patient had no Known allergies except latex band aids. Concomitant medication included vitamin d3 and rosuvastatin calcium (CRESTOR). Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination and post vaccination. It was reported that After the first shot patient had slight rise in blood pressure and pulse after about 5 days but otherwise just felt tired. As treatment patient received Benicar 40 mg and Lorazapam.5 mg, Zicam. The patient underwent lab tests and procedures which included blood pressure measurement: rise on Feb2021 slight rise in blood pressure and pulse, heart rate: rise on Feb2021 slight rise in blood pressure and pulse. On an unspecified date in 2021, the events was resolved with sequelae. No follow-up attempts are possible. No further information is expected.

Room began to spin around while I was sitting in, I was so dizzy that I couldn't open my eyes; couldn't lift my head off the pillow/Extreme dizziness for 7 hours. Unable to function or open eyes.; My lips started tingling slightly and my tongue started tingling slightly; tired a little; This is a spontaneous report from a contactable consumer (patient). This is the clone master case and was report 1 of 2. A 76-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205; Expiration Date: 30Jun2021, UPC, NDC number of Covid 19 vaccine: Unknown), via an unspecified route of administration, administered in left arm on 06Mar2021 at 10:45 (vaccination at the age of 76 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included supraventricular tachycardia, slight hypertension and high blood pressure. Concomitant medications included atenolol and menthanenine; the patient received both medications within 2 weeks of vaccination and taken for an unspecified indication, start and stop date were not reported. The patient was allergies to medications, food, or other products includes clindamycin, ampicillin, erythromycin and novocain. Vaccination facility type was reported as hospital. The patient stated, patient received my first shot 06mar2021, Saturday and about 15 minutes after the shot, my lips started tingling slightly and my tongue started tingling slightly so they had me sit there extra 15 minutes that was okay, basically no big deal. The problem came in was, now I got the shot at 10 o'clock in the morning, at 7 o'clock in the evening, the room began to spin around while I was sitting in, at 7:45 PM, was so dizzy that I couldn't open my eyes because every time I open my eyes I felt like I was on a carousel it was just going round and round so my husband helped me to bed, helped during the night, this lasted till 4 o' clock in the morning. My concern is what will happen with the next shot. states she tried to open her eyes and could not open her eyes and it was like she was on a carosel and the room was spinning which lasted until 4:00am the following morning and is now completely resolved. The patient stated she was not too much concerned and heard from people that might have happened with them. The sensation on her tongue and lips after the 1st dose of the Pfizer COVID19 vaccine was very slight in sensation and it was completely resolved and did not last long at all and was resolved within a minute. Caller states she was tired a little bit but at her age that happens and she had a full day yesterday and is going to say that her arm did not bother her after the Pfizer COVID19 Vaccine and other people said that their arms bothered them but she did not have that; She has no other patient information to provide. Event dizziness resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The patient not had covid prior vaccination and the patient was covid tested post vaccination. Prior and since the vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included blood test and covid-19; both were negative on 22Mar2021, and reported as In the last 2 weeks, the patient did go for a Covid test because patient supposed to go for surgery on Wednesday to have, had a problem with bladder, it's kind of dropped down on one side. Outcome of the event My lips started tingling slightly and my tongue started tingling slightly was recovered on 06Mar2021 and other was recovered on 07Mar2021 and event tired a little was unknown. Follow-up attempts are completed. No further information is expected.

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.

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

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.

PFIZER-BIONTECH COVID-19 EUA. PATIENT FULLY VACCINATED WITH PFIZER COVID-19 VACCINE. 7/19/21 4:19PM: TESTED POSTIVE FOR COVID-19. COUGH WITH CONGESTION NOTED. 02 SAT 97%. 7/20/21 10:57AM: O2 SAT 98%, AFEBRILE. NO COMPLAINTS. 7/20/21 8:30PM: PATIENT 02 sat 77% RA, SOB, non-prod cough, wheezes/crackles TO LUNG FIELDS. PLACED ON O2 @4L, O2 CAME UP TO 82%. PATIENT VERY LETHARGIC. AFEBRILE AT 98.4. NURSING FACILITY SENT TO ER.

Patient experienced 1 week of cough starting on 7/2 , tested positive for COVID-19 on 7/9 and was admitted to the hospital from Nursing Home - brought in by EMS. Per EMS - patient was on antibiotics at the nursing home. Only received one dose of Pfizer vaccine.

she has developed chills; her fingers were turning blue.; her fingers were turning blue.; This is a spontaneous report from a contactable consumer and from a Pfizer sponsored program COVAX US support. This 76-year-old (age at vaccination) female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6207, expiration date; 31Jul2021, Pfizer COVID 19 vaccine manufacturer; Unspecified, NDC number; unknown) via an unspecified route of administration on 17Mar2021 at 10:30 at left arm as dose 2, single for covid-19 immunisation. Vaccination facility was Health and Wellness Center. Patient's medical history included blood pressure high, high cholesterol, knee replacement from Jul2020 to unspecified, heart problems, breast cancer (dates unspecified). Patient mentions predating treatment with the Pfizer COVID 19 vaccine, she had knee replacement surgery in Jul2020 and Nov2020 and had a COVID 19 test done before each time. Both the COVID 19 test from Jul2020 and Nov2020 were negative. Family History included mother heart problems; sister breast cancer; daughter breast cancer; father cancer. Relevant tests included two COVID-19 tests both negative on Jul2020 and Nov2020. Historical vaccine included first dose of BNT162B2, lot number: EN6199, on 24Feb2021 at 10:30 am in left arm for covid-19 immunisation. Concomitant medications were not reported. Prior vaccinations (within 4 weeks) were reported as none. Consumer had the first dose of the Pfizer COVID-19 vaccine on 24Feb2021 and had no reaction after. Consumer got the second dose on 17Mar2021. On 24Mar2021, she has developed chills and her fingers were turning blue on 24Mar2021 to ongoing. Reporter seriousness for the events was unspecified. The AEs did not require a visit to emergency room or physician's office. Consumer wanted to know if that is an adverse events associated with the vaccine and if those are adverse events that would go away. She also would want to know if she should go to the ER for it. Consumer states she has received both of the vaccines. Last week on 17Mar2021 she got the second dose. Then on 24Mar2021 she noticed chills; and her hands and fingers turned blue. They are still that way today. She didn't know if she should call Pfizer or call the wellness center. She is asking if this will go away or should she go to the ER? Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 24Feb2021 at 1030 am in the left arm and had no reaction. Then she had the second dose on 17Mar2021 at 1030 am in the left arm. Patient does not see NDC on her vaccination card. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

Resident received Covid Vaccine, noted after 30 mins with labored breathing BP 161/77, HR 116, R 38, T 101.4,

Pt vaccinated on 12/23. PCP notified that SOB and fatigue getting worse on 1/4. Unable to keep pre-op Dental work planned prior to mitral valve surgery on 1/14/2021. PCP referred her to our ED where she was diagnosed with COVID-19 and transferred to facility, which is where her surgery was planned.

After receiving the vaccine, she verbalize feeling different in her head and headache. She was evaluated onsite by Fire Rescue and Dr. onsite and released home at 10:50 am feeling better.

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.

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.

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.

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

About 19 hours after receiving the Pfizer Covid-19 vaccine, I got a fever of 101 degrees. My left arm felt very heavy.

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.

Fever; Headache; Chills; This a spontaneous report from a Pfizer-sponsored program by a contactable consumer (patient). A 77-years-old female patient received first dose of bnt162b2 (Covid-19 vaccine, Batch/lot number: EL3246), via an unspecified route of administration on 07Jan2021 at SINGLE DOSE on left arm for covid-19 immunisation. Medical history included ongoing blood pressure. Concomitant medication included amlodipine (AMLODIPINE), bisoprolol fumarate/hydrochlorothiazide (BISOPROLOL/HYDROCHLOROTHIAZID), both since 2015 and ongoing for blood pressure. The patient experienced fever, headache, chills on 08Jan2021. Everything happened at night time. Her temperatures have been 100.4 and 100.5 degrees. The headache only lasted for a couple of days. It was also only at night. The patient underwent lab tests and procedures which included blood pressure measurement: fine on 12Jan2021, body temperature: 100.4 and 100.5 degrees on an unknown date. The event outcome of fever, headache was not recovered; outcome of chills was recovering.

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.

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...

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.

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.

Slight swell in face, lips, cheeks; feeling of tightness; redness in face;, some nasal drainage. Similar to reaction to hot peppers. Took 1 Benadryl tablet. Symptoms subsided over 24-hour period.

fevers; congestion/stuffiness; This is a spontaneous report from contactable consumer (patient). This consumer reported similar events for two patients. This report is for the first of two patients. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medication included metoprolol for high blood pressure. The patient experienced fevers and congestion/stuffiness on 15Jan2021. Patient stated that she and her husband got the first shot of the COVID 19 vaccine on 09Jan2021. She began to run a fever today and has stuffiness. Patient wanted to know are these side effects of the vaccine and would these side effects start so many days after the vaccine. She was told that she can not get tested for COVID because she has had the vaccine. Patient is supposed to go back on the 30th for second shot. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046472 same reporter, drug, event, different patient

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.

Persistent headache followed 12 hrs later by mild dizziness, nausea, feeling vaguely ?off, now in 4th day. BP slightly elevated this morning 138/80.

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.

I developed a headache; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246 and expiration date not provided), via an unspecified route of administration (left arm) first dose on 10Jan2021 17:00 at single dose for covid-19 immunisation. The patient's medical history included Anemia, Chronic Rhinitis, Rheumatoid Arthritis, Osteoarthritis, Kidney Disease Stage 3, and Gerd. The patient's concomitant medication included fexofenadine hydrochloride (ALLEGRA), rosuvastatin calcium (CRESTOR), prednisone, darbepoetin alfa (ARANESP), and clopidogrel. The patient previously took Phenergan and ACE inhibitors; both experienced allergies. On 16Jan2021 18:30, the patient developed a headache. The patient did not received treatment for the event. The outcome of the event was unknown.

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.

Patient complained of dizziness and said she was going to pass out. Observation nurse called site clinical lead over, at that time the patient was responding to verbal cues. Mask was taken down and she was guided to take slow deep breaths, continued to report feeling as though she was going to pass out. Site clinical lead then noted patient with fixed gaze to the size, clenching hands and rigid posture. Observation nurse called for EMS assistance. Patient breathing slowed, mouth open, eyes remain fixed to the size with rigid posture for 5-10 seconds. Patient did not respond to any verbal cues. Site clinical lead and observation nurse lowered patient to the floor, at which point patient became responsive. Responded correctly to reason for visit to site, location and how she was feeling. Denied history of seizures or stroke. Reported feeling anxious and needing to use the bathroom. Did not appear to lose bowel control at any point. Patient was very diaphoretic and pale, but alert overall. Cold compresses applied to forehead and back of neck while patient remained supine. EMS arrived and had patient sit up, at which point she again became very pale and reported feeling as through she was going to pass out. EMS transported to hospital for further evaluation.

Increase in cardiac arrhythmia - a-fib and rapid pulse, up to 135bpm while asleep Muscle and joint pain Fatigue

Sore arm started in the middle of the night--still sore two days later. General achiness all over. General tiredness.

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.

sore arm, chills and exhaustion so bad came close to being nauseous. All in first 24 hrs. Was fine 24 hrs later

24 hrs after shot i ran low fever and head ache. i had fatigue, But then i started 2ays later feeling like i had inflammation in my butt, external in vaginal area and was hard to use the restroom and back of thighs area. felt like a had a rash but there was nothing there. like it was burning. it just felt inflamed. It felt good to apply cold to it. it lasted until the next day.

Pt reported that she had a Pfizer vaccine on 2/7 at 10am and went home and experienced chest pain at 1pm that lasted for only a few seconds. Pt also experienced a mild SOB while walking in the hallway. Mild SOB was only lasted for a few secs (prior to chest pain). Pt stopped and rested and Pt felt fine afterwards. Chest pain Hx: Upon assessment, Pt also reported that pt experienced chest pain x1 (6 months ago) which also lasted for a few seconds. But, pt never reported this to pt's physician. Other Sxs: Symptoms: Headache. Onset: 2/8 AM. Pt took Tylenol 1000mg this 9am. Pt states she usually takes QAM for her arthritis. Effect: "It did not help." Pt denies any change in vision, blurry vision, double vision. Denies NV. Pt denies any chest pain or SOB today. Pt was able to speak clearly in full sentences. Pt was able to do ADLs without this morning. Pt stated, " I am able to carry on all my chores without difficulties. Other than headache I feel completely fine." No distress noted that needed an emergent care. Recommendation -Pt denies any significant related symptoms such as ?worst headache of life? or changes in vision, speech, or coordination, or nausea/vomiting. -Instructed to take analgesics such as Acetaminophen after 4-6 hrs (Adult dose: DO NOT EXCEED 4,000mg per day unless directed by the doctor) according to package instructions provided there are no contraindications. -Advised to rest and increase water intake. Education: -If pt experiences any chest pain, SOB, visual changes, change in mental status, N/V or ?worst headache of life?, pt was advised to go the nearest ED. -If headache is severe, focal, progressive or persists > 1 day: Pt was advised to reach out to PCP same day.???If PCP is not available should seek care at Urgent Care. Pt verbalized understanding and agreed with the plan.

Pt developed Shingles after vaccination. Notes from call to PCP day after vaccination: "Since yesterday morning after vaccine after she received her covid vaccine, she noted that her right ear hurts. She says that the pain does not feel like it is in the ear but right around the ear, and the bones around the ear. She says it hurts to chew, and the area to the back of her ear has ringing sound. She does not note that the ear is red . When she rubs under the ear she says the area is painful is painful. She does not note a lump or bump under her ear.. She states that the jaw/bone area hurts with the vibration of the conversation." Sore throat and headache, only on right side. Pain progressed to the point of hospitalization, with vesicles erupting on right side of face/ear canal.

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.

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.

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.

trouble sleeping; right arm plus red; right arm feel ithcy inside; night chills; headache; arm hurting/right arm pain was more painful; This is a spontaneous report from a contactable other health professional (reported for herself). A 77-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/lot number: E69261), via an unspecified route of administration in right arm on 27Jan2021 11:15 at single dose for covid-19 immunisation in hospital. Medical history included, two stents, hernia, prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included omeprazole, rosuvastatin, ticagrelor (BRILINTA), metoprolol, sucralfate (SUCRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin sodium; clavulanate potassium (AUGMENTIN), carisoprodol, clopidogrel bisulfate (PLAVIX) all experienced allergies. First it was arm hurting first night on 27Jan2021, then next night on 28Jan2021 chills, headache occurred, last night on 29Jan2021 she had trouble sleeping. Her right arm pain was more painful, plus red, feel itchy inside, took diphenhydramine (BENADRYL) 1 tablet. The events were non-serious. The patient's COVID test post vaccination included nasal swab on 27Dec2020 with result negative. Outcome of the events was unknown.

Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported itching at injection site and in throat. Initial vital signs within normal ranges except pulse 100-110 beats per minute and blood pressure 180/90 mmHg. Patient administered diphenhydramine 25 mg orally and transported to the emergency department. On arrival and during physical exam patient noted to have red "splochyness" on chest wall but no hives. Patient awake, alert, oriented: no shortness of breath, stridor, or oral or pharyngeal swelling. Patient observed, symptoms improved, vital signs stable, and discharged to home.

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.

chills; general body aches; fatigue; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: el9262, exp date not reported), via an unspecified route of administration (Vaccine location: Left arm) on 22Jan2021 15:00 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other (not specified). Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. The patient had no allergies to medications, food, or other products. There were other medications patient received within 2 weeks of vaccination (not specified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021, the patient experienced severe chills lasting for another 24 hrs; then general body aches and fatigue lasting for 3 days. The events were considered as non-serious by the reporter. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.

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.

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.

RECEIVED COVID VACCINE 1ST DOSE ON 02/03/21. REPORTED TO ICC ON 2/12/21 FOR HEADACHE, NO TASTE, FATIGUE, AND CONGESTION. REPORTED COVID EXPOSURE 1 WEEK PRIOR. HAD POSITIVE COVID PCR 02/12/21. RECIEVED BAM INFUSION ON 02/12/21.

Had shot on 2/3/21 and on Thursday around 2.00am started to feel pressure in temple area. It lasted until Wed ..one week like a vice on my temples. Called Primary Dr. office and spoke to PA. She prescribed IMITREX for migraine but I took Excedrin with Caffeine and it did not help. I have not taken the IMITREX because we've had an ice storm and couldn't get it. Wed my head felt much better...I was so happy..then last nite around 2.00am again it returned! Not as bad as before but it still returned.

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.

On first day had chills, sore throat, both minor. Second day had fatigue, moderate joint and muscle pains. Third day, some muscle pain.

02/05/21 6:00PM total exhausion, chills, headache, joint pain, felt like I had the flu. Also, my eyes seem to have new floaters, and I felt strange in my head. 10:00pm the symptoms continued, but when I got in bed I had terrible nauseau so bad that I couldn't sleep. The next morning my symptoms continued but did not worsen, and then I got so dizzy that I was stumbling. This all continued for three days. On 02/09/21 my symptoms subsided, and I felt normal again

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.

Maybe this is not what is qualified as "adverse", but i have not been able to get out of bed, eat, or do anything but sleep for 2 days. Runny nose and stuffed up sinuses, low grade temp not above 100.5. Muscle aches It is now almost 6 pm Sunday. I think I can eat some soup now. Temp is gone I think I'm recovering.

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

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.

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.

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.

fuzzy thinking; fatigue; pressure in head; dizzy; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: L33U2) via an unspecified route of administration in Left arm on 20Jan2021 11:30 AM (at the age of 77-years-old) at SINGLE DOSE for COVID-19 immunization. The patient's medical history included high cholesterol, back scoliosis. Concomitant medications included cholesterol, vitamins, minerals. The patient was not pregnant. No known allergies. No other vaccine in four weeks. The patient experienced fatigue, pressure in head, fuzzy thinking, dizzy on 22Jan2021 06:00 AM. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the events. AE treatment included antibiotics. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination: Nasal Swab (normal and rapid) tested on 02Feb2021 showed negative result. The outcome of the events was not recovered.

Sore left arm from 2/16/2021 thru 02/18/2021. Extreme fatigue and tiredness from 02/17/2021 thru 02/18/2021

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

pt stated that she developed hives on her torso and both legs down to the knees and slight headache after taking the covid. Pt states her symptoms are improving.

Severe flu-like symptoms--headache, achy body, queasy stomach, extreme fatigue lasting for two days keeping patient bedfast.

Itching/hives bilateral axilla. Sensation of lump in throat/itching tingling in throat. EMS on site. Patient's Epi-pen used left thigh. EMS started IV in left AC gave fluids and gave 25 mg Benadryl IV. Vitals monitored. Symptoms improved shortly after medication administration. Med unit transported patient to hospital for further evaluation.

As per patient daughter - patient had some minor chills on the day of the vaccination - Friday 1/15/21; felt well next day -Saturday, than she was found slumped and lifeless on the couch on Sunday 1/17. Cause of death on death certificate was reportedly put as COPD, Lung Ca and ASHD.

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.

This was my second vaccination at the same site. I was fine with the first shot, and seemed fine with the second one until the next afternoon around 3:00 p.m. All of a sudden I could feel some aching in the back of my neck and just a feeling of aching down my back. Then I started to get the chills, chills that were so bad my body was almost convulsing with chills. I ended up going to bed and I turned my electric mattress pad on to warm up. I then slept very well and I don't think I moved all night. I woke up sort of achy, but not much to be concerned with.

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.

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

severe overall headache; nasal congestion; This is a spontaneous report from a contactable consumer (self-reported). A 77-year-old female patient (who was not pregnant at the time of vaccine) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9261), via an unspecified route of administration, at Left Arm on 03Feb2021 13:30 at single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM 11), hypertension and hypothyroidism. Concomitant medication included metformin, levothyroxine sodium (SYNTHROID), hydrochlorothiazide, triamterene (DIU) and blood pressure medication (unspecified). The patient previously took ibuprofen and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination, included; blood pressure Med, metformin, synthroid, DIU. The patient was the not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. On 04Feb2021, the patient woke up at 3 AM with severe overall headache and nasal congestion. At 6: 30 am took Tylenol tabs 2. Had head and nasal congestion as well and no treatment was taken for nasal congestion. Symptoms did not clear up for nearly 10 hours. Outcome of the events was recovered on an unknown date in Feb2021.

Experienced bad taste in my mouth right away, lips felt weird, breathing very raspy, chills, itching on head, ears, arms, headache, swallowing issues, stuffy nose, sinus pressure, extreme fatigue, dry mouth (felt like cotton in my mouth), temperature dropped. Took about five days to feel okay. Took Benadryl (took twice with six hours between doses, took antihistmine, Levocetiriine, used pro air quite often, 20 mg of Prednisone at 2:30 am on the 22 and finally felt relief. Dr.. was informed after I got better.

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

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

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.

The day after 2nd vaccine, temp went to 100, body aches, severe fatigue. My temp went back to normal on 3rd day, however had fatigue and body aches for 4th and 5th day.

Presented to the ER with complaints of fever, shortness of breath including nausea vomiting and diarrhea. She started getting ill after receiving her second dose of the Pfizer Covid vaccine. Admitted to hospital for 2 day stay.

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.

chills, nausea,metallic taste, half an hour after shot felt sick and had chills bad taste in mouth. lasted that day and next day. felt fine after that

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

Client report having COVID in November 10, 2020. Client received first dose on 02/09/21 at 2 pm, reaction of SOB began two hours later. SOB progressed to chest pain and fatigue. She sat at kitchen table to relax and rest, fell asleep for 2 hours. When she woke up she continued to have trouble breathing, drank some warm tea, went to bed and slept for 12 hours. This is not usual for her sleep schedule. The next day she felt better for a couple of hours then had some difficulty breathing again. She went to Urgent Care. EKG and chest X-ray preformed came back normal. Blood pressure was elevated. Client given 4 puffs of an inhaler. Discharged to home.

patient felt extreme fatigue and weakness -- trouble in moving and getting to bed-- layed down for 30 min and improved after 30 minutes

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.

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.

dizzy; broke out into a sweat; feeling a little nauseous; chills; breast cancer stage 1/taking anastrozole; breast cancer stage 1/taking anastrozole; 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: ELV5318, expiry date unknown), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunization. Medical history included stage 3 kidney disease, breast cancer stage 1 and blood pressure abnormal (reported as 'blood pressure') all from an unknown date and all ongoing. Concomitant medication included anastrozole (manufacturer unknown) for breast cancer, levothyroxine (manufacturer unknown) for kidney disease and amlodipine (manufacturer unknown) for blood pressure. The patient has breast cancer stage 1 and was taking anastrozole. The patient got the vaccine on 30Jan2021 and did not have any side effects 22 hours later, on the day of the report, 31Jan2021. The patient was grocery shopping and became very dizzy and thought she has to keep this together. The patient then just broke out into a sweat and managed to get herself home. She was feeling a little nauseous and she got the chills and then it (unspecified) was pretty much over in about 2-3 hours. The patient was scheduled for the second dose on 20Feb2021. The patient did not receive any treatment for the events. The outcome of the events was unknown.

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.

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.

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.

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.

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.

Patient developed h/a 8/10right after injection he was observed and felt nauseous. ER MD came and saw patient x2 patient allowed to go home. H/A better he stayed 1.5hours. he was transported by wheelchair to vehicle

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

she was hospitalized 2.5 days after having symptoms of a "massive heart attack" 2 days after the vaccine; blood clot; pain on the left side/pain so bad/ pain was so severe couldn't bent over and couldn't get up; pain was in the heart and underneath the rib; pain was in the heart and underneath the rib; had a little trouble breathing; broke out in a sweat; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect 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/expiration date unknown), via an unspecified route of administration on an unspecified date in Feb2021 at a single dose for COVID-19 immunization. Medical history included asthmatic, had double pneumonia years ago, has ongoing atrial fibrillation and a pacemaker to control it as the only problem she has in her heart. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient was hospitalized for 2.5 days after having symptoms of a massive heart attack two days after the vaccine. It was reported that two days post vaccination, the patient was rushed to the hospital by ambulance as they thought she was having a massive heart attack. She added her symptoms lasted for hours, she had pain so bad that she was bent over and had a little trouble breathing. She said the pain was in the heart and underneath the rib, on the left side. She later mentioned she did not feel like it was AFib. She said they did every test possible and listed the following ones: ultrasound, stress test, x-ray (unknown results), and blood work in Feb2021. She specified that her blood work indicated a blood clot. She mentioned she was told by her personal friend, who was a doctor, that by having the shot sometimes it indicated you have blood clots when you really don't. The patient also specified that she broke out in a sweat, the pain was so severe that she could not bend over and could not get up; therefore, they treated her as if she was having a massive heart attack for 12 hours at the hospital. It was reported that they kept giving her stuff to stop the effect with her heart. She mentioned her second dose was scheduled on 25Feb2021. She asked if her experience was reported as a side effect to the vaccine and should she get the second dose of the vaccine. She explained the doctors did not know what she had, and she needed to determine if she can receive the second dose. She also asked if we could notify her if a similar reaction is reported. The outcome of the events was unknown. Information on lot/batch number has been requested.

She has been able to eat, but nothing taste that great; had a day and a half of diarrhea; She is having chills occasionally; She feels totally exhausted; she has felt so stupid; she doesn't feel well enough; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), via an unspecified route of administration at left arm on 27Jan2021 13:50 at single dose for COVID-19 immunization. The patient received the vaccine due to her age and she was due for it. Medical history included fractured ankle. Pateint's height was five two and shrinking. She is on (networking site) with people she went to high school with and they are all getting the shot at same time because of their age. They were all saying they have had no side effects and no symptoms. There were no concomitant medications. The patient read the information they gave her after the shot. Now, she knows why she has felt so stupid. It was all the stuff on the list. On 28Jan2021 about 19:00, she had a day and a half of diarrhea and she was having chills occasionally. On 28Jan2021, she felt totally exhausted. A little bit of everything. She was not nauseous. On 29Jan2021, she has been able to eat, but nothing tasted that great. Even when her son got her what she wanted it still did not taste great. She is coming off a fractured ankle and she is going to have cancel therapy because she doesn't feel well enough to do that. She got the first vaccine on 27Jan2021. It will be a week on Wednesday. On Thursday and Friday she had diarrhea. Serious quantity of Pepto Bismol kept that at bay. The exhaustion has only improved a little. It was good for her to get up and move. No additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to Emergency Room or Physician Office. No prior vaccinations (within 4 weeks). The outcome of the event diarrhea was recovered on 29Jan2021; events chills and exhausted was recovering; event 'she has been able to eat, but nothing taste that great' was not recovered; and unknown outcome for the other events.

Ears are messed up; her ears are swollen on the inside; Running a temperature/low-grade fever; Headache; Nervousness; like a chronic ear ache; infection somewhere/earaches which turned out to be infected; 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 number: EL1284; expiry date: unknown) , via an unspecified route of administration in the left arm, on 18Jan2021, at a single dose for COVID-19 immunisation. Medical history included ear problems in the past and sick. There were no concomitant medications. The patient had her first COVID shot on 18Jan2021. By Wednesday, two days later (20Jan2021), both ears were messed up, she was running a temperature (also reported as low-grade fever), had a headache, and was very nervous. She went to the doctor and her doctor gave her an antibiotic shot, two steroid shots, and some antibiotic ear drops, which did not work. She then did a home call with the doctor and she provided more steroids, an oral pack, and an oral antibiotic for 5 days. She was still having problems with her ears. Mainly her left ear. It goes from ear to ear. She went to the ENT about the earaches which turned out to be infected, and has subsequently been on two rounds of antibiotics, with persistent symptoms that have gotten better over time. Patient wanted to know if this could relate to the COVID Vaccine. She has never had this happen before, and she has been really sick but not this bad. She has had ear problems in the past, but normally the antibiotic liquid drops clear it up. It was like a chronic ear ache. Her earaches were hurting bad. What she is wondering is if it could be a side effect from the first COVID shot. She clarifies that her ears are swollen on the inside. It was an infection somewhere. The antibiotics and steroids have not healed it up. All of these events were still occurring but come and go. For instance, yesterday she had a low temperature but has not yet had one today. The antibiotic ear drops prescribed were Neopoly HC OTSC 1% OTIC SU. NDC: 24208-635-62. Expiry date: Jun2022. She was unsure what the lot was but also sees: 349111. The oral antibiotics she has is Amoxicillin 875mg/125mcg. These are in a pharmacy vial. Use before: 26Jan2022. She was given two steroid shots. One shorter acting and one longer acting. She was unsure of the names. Oral steroid pack: Manufactured by Pharmaceutical name. Prednisone USP 5mg. REV 1016. 314518. lot: 1150419. Expiry date: Feb2022. She also pre-treated with allergic reaction medications. She goes back to the ENT on Thursday. Patient wanted to know if these had happened to anyone before. Outcome of the event pyrexia was unknown, for events ear swelling, ear pain and ear infection was recovering, while for the other events was not recovered.

became totally nauseous; light headed; very chilled; extremely tired; very cold; Fell asleep under warm down quilt until 2:00pm (total 13 hours sleep); 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 Lot number en5318, Expiry date not reported) via an unspecified route of administration to left arm on 26Jan2021 08:15 at single dose for covid-19 immunization. Medical history included UTI (urinary tract infection), rosacea, severe breathing problems, no sense of taste or smell, severe bronchitis, pneumonia, productive cough (productive cough that lasted for 2 months) and known allergies: some eye drops; some pain killers (nausea). The patient became totally nauseous, light headed, very chilled, extremely tired, very cold, fell asleep under warm down quilt until 2:00pm (total 13 hours sleep) all on 31Jan2021. The events were reported as non-serious. Reporter states she Woke up 8:00 am and dressed. Felt fine until 9:00. Had some milk tea and 2 morning pills and became totally nauseous and light headed. Went back to bed immediately. Became very chilled, and extremely tired. Checked temperature at 97.5 and was very cold. Fell asleep under warm down quilt until 2:00pm (total 13 hours sleep). Felt better, but ate little and wore a coat inside. After a light dinner, nausea mostly gone, but still tired. Reporter added that she almost certainly had a serious case of Covid in early February, 2020. Nobody knew the symptoms, so both urgent care and the ER sent her home with minimal treatment. She had severe breathing problems, no sense of taste or smell, severe bronchitis with some pneumonia (X-ray), and a productive cough that lasted for 2 months. The patient underwent lab tests and procedures which included body temperature: 97.5 (Unit unspecified) on 31Jan2021 and x-ray: some pneumonia on an unspecified date. No treatment was received for the adverse event. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovering.

Aches all over my body, tiredness; lasted only one day. Got some sleep no symptons the following day

1o minutes after receiving the vaccine client started c/o feeling her heartbeat in her head. This lasted for a few minutes. Information was obtained by a neighbor that lives 4 doors down from her. She has had no other problems.

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.

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.

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.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports fatigue, myalgias, chills, and a swollen arm (at injection site) starting one day after receiving vaccination. Patient previously had COVID-19. During clinic visit three days after vaccination symptoms have resolved without intervention.

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.

injection site pain; Nausea; fatigue; joint and muscle pain; joint and muscle pain; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), via an unspecified route of administration on 20Feb2021 at 08:45 at a single dose in the right arm for COVID-19 immunization. Medical history included stage 4 breast cancer and thyroid cancer. Concomitant medications included levothyroxine sodium (SYNTHROID) and lorazepam. The patient previously took sulfur and experienced allergies and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. 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. The patient was not pregnant at the time of vaccination. On 21Feb2021 at 04:30, the patient experienced injection site pain, nausea, fatigue, joint and muscle pain, headache, and chills. The patient did not receive any treatment for the reported events. The patient underwent lab tests and procedures which included Nasal Swab/COV-2 RNA (RT-PCR) NAAT with negative result on 09Oct2020. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.

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.

Fatigue began first lasting for 24 hrs. Fever noticed after first 12 hours along with chills. Took one Tylenol 15 hrs after first symptom which did not provide any relief. At hour 20 the fever returned to normal and fatigue and chills subsided.

Fever of 101 for one day, extreme ongoing, almost incapacitating fatigue is still continuing almost three weeks and counting

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.

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

ct reports having fever, body aches, stomach pain with nausea and diarrhea, palpations, rash on her face, vision problems

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.

The next morning, she could hardly wake up and had no appetite. Saturday still no appetite but did drink and slept a lot, also extreme fatigue, headache. Neck and up the back of head was very painful. Had muscle pain throughout. Feels really good today.

Bedridden for 11 days with pain, headache, chills, loss of appetite, Extreme fatigue, Raynaud?s. Blood test on 12th day revealed high sed rate and abnormally high platelets ( twice normal)

Second Pfizer on 3/1, head cold and congestion on 3/7-9, with productive cough, stuffy nose, sore throat,

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

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.

dizziness; nausea; heart palpitations; fatigue 13 days; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (herself) reported that a 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EL9269) via an unspecified route of administration in left arm on 11Feb2021 14:00 at single dose for Covid-19 immunization. Medical history included Cholesterol, high blood pressure and history of ovarian and breast cancer. Concomitant medications included Pregabalin, rosuvastatin calcium (CRESTOR), fluoxetine hydrochloride (PROZAC) and amolodipine. Patient is good health had a bad reaction to the 1st COVID dose vaccine. Ended up in hospital emergency room on Friday 18Feb2021 with extreme dizziness and nausea and heart palpitations. Fatigue which had been going on since Friday 12Feb2021 14:30. Having had these reactions patient need to know from Pfizer is it safe for me to have second dose which is scheduled 04Mar2021. Seriousness was reported as non-serious. Patient did not receive treatment for events. No follow-up attempts are possible. No further information was provided.

she felt a little dizzy/a little dizziness; headache; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 04Feb2021 (at the age of 77-year-old) at a single dose for COVID-19 immunisation. Medical history included cancer, heart problems and ongoing COVID. The patient's concomitant medications were not reported. The patient reported that she has had a light case of COVID and took the COVID vaccine this morning. She said that after receiving the vaccine, she is experiencing, not major, a little dizziness/dizzy and headache on an unknown date in Feb2021. She is not really worried about it. She did not want to take anything before she called and verified if it was ok; but she called to ask if she can take TYLENOL after having gotten the vaccine. The outcome of the events was unknown. Information on the lot/ batch number has been requested.

1. I feel like I am going to fall, unstable gait with head pressure. 2. Generalized dizziness. 3. Scared and my heart races.

Severe plantar fasciitis onset first week of February. By February 14, severe bilateral trapezius pain radiating to base of skull and shoulders. Fatigue. Chills. Nausea. Headache. Had repeat PCR Covid test at facility. Negative. Naproxen for approx 10 days of no benefit. Heel pain, shoulder/neck pain, fatigue, chills, nausea and headache continued. Saw FNP BC March 8, 2021. Symptoms continued through March 16.

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.

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.

flushes - feeling hot on her chest as per patient; BP=180/104; HR=66, O2=96RA; lungs-clear. Hx-HTZ, increased cholesterol, hypothyroid.

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.

On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body aches dry cough shortness of breath and subjective fevers as aggressive worsening since Friday. Patient received a 2nd dose of the pfizer COVID-19 vaccine on Friday 3/12/21 and states her symptoms worsened since then. Chest x-ray showed patchy bilateral infiltrates with concern for COVID pneumonia, also questionable vascular congestion as patient does have significant history of heart failure with pacemaker. EKG revealed paced rhythm 87 beats per minute. Emergency room patient was placed on BiPAP and responded well, patient was given vancomycin and cefepime for sepsis protocol.

Rapid onset of fatigue following 15 minutes post observation time, guest sat in chair and notified staff (11:42). Took her own prescribed carbidopa prescription as she stated she was due for a dose and that fatigue is common feature of her Parkinson's and that she usually feels better 20 minutes after medication. She then reported shortness of breath that felt "different" than her usual shortness of breath so internal aid was called for. EMT staff assessed guest to find vital signs stable and able to speak full sentences. Guest reported feeling better at 12:15 and was moved by wheelchair to her ride to go home.

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.

Painful Headache; Arm where I received the vaccine is still sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of BNT162B2 (COVID-19 Vaccine, lot number: EL9264), via an unspecified route of administration, administered in upper left arm on 09Feb2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. Medical history was none. Concomitant medication included vitamins (unspecified). The patient called to report that with the second shot, she experienced painful headache for 6 day no its more than 6 days and everyday she woke up with a horrible headache and this never happened before so she was assuming its because of that shot. She still has it and have been up already for four hours and already took two Tylenol (treatment). Also, her arm where she received the vaccine was still sore. The events occured on 09Feb2021. The outcome of the events was not recovered.

Pt received the second dose of the Pfizer vaccine. The patient waited 15 minutes in the observation area. Once the patient left the building, her husband returned with her within 5 minutes of leaving bc, he noticed her having swelling of her left lower lip and itching in the throat with some difficulty breathing. She was attended to immediately by EMS, PA& physician at the site. Vitals were obtained: blood pressure was elevated at 220/110, PO2 96% pulse 115 BPM. A dose of 50 mg of benadryl was given to the patient orally. Within 10 minutes she felt improvement in her breathing and the swelling in her lip was not as prominent. BP remained elevated 200/100 , transported to hospital for further Tx & observation.

March 12, 2021 - On Friday about 2pm, I started with a runny nose ? by Sunday afternoon it was like a faucet turned on ? running down my face. March 13 - Saturday morning, I started coughing c chest congestion, and had Phlegm rattling in my chest, started sneezing very frequently/ some diarrhea. Otherwise, I felt fine. March 14 - Sunday morning, I started wheezing slightly, coughing more and sneezing frequently. Felt fine. Went shopping. Nose ran so much in store, had to run to the store to get paper towels to catch it. Later, when I carried a heavy bag of groceries from one car 12 feet to another, noticed I was very exhausted and had to rest about 15 minutes before driving home. Wheezing more. Monday, March 15, I took my B/P meds at 1:00am and my blood pressure was way up x 4 (160?s/ 70?s) p58-64, at 2:08am ? B/P was 183/92) so I took my PRN Clonidine and ate all the high Potassium foods I had in the house. By 3:40am my B/P was 120/66 but went back up later with coughing. I felt fine but tired. A little after 4am, I carried a bag of apples and a bag of oranges up my stairs and was totally exhausted ? I felt the energy draining out of me, and so was out of breath I dropped the bags on the floor and sat hyperventilating to get enough air in my lungs until I could breathe normally ? for 40 minutes - it felt like fluid building in my lungs. I started massaging my abdomen like crazy and coughing until it subsided ? considering whether I should go to E.R. My breathing did get some better But I sure did not exert myself. Just picking up my computer was taking my energy. Still coughing and getting rid of some phlegm. This was very scary and I was on the verge of going to the E.R. at 4:45am - I called the E.R. who said I probably could wait for a urgent care to open or talk to Dr.?s office. My breathing was some better. By 6:10am I was so tired I fell asleep. At 10am my B/P was 138/77 p53. Still very weak, coughing, wheezing, and trying to get rid of phlegm. I had no other symptoms. I called my Dr. who got me in a urgent care in her building at 3pm. That evening I started Postural Drainage which helped in getting rid of the phlegm. I have continued that still. March 16 ? I ?chatted? my doctor to let her know all that was going on. She scheduled me to see the Respiratory office in her building on the next day. I was feeling much better ? little nasal dripping, lungs felt better, March 17 ? Wednesday ? went to Respiratory appt but declined treatment because I felt so much better. More energy, better lungs than Tuesday, wheezing gone, less phlegm, still some coughing ? which is okay with me. I think this is a severe enough reaction that I should not have the second dose ? which is known to be more severe than the first.

aches; Chills; Fever; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 10Feb2021 (Batch/Lot Number: EL9266) as SINGLE DOSE for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing Patient History: No. There were no concomitant medications. The patient experienced aches (pain) (non-serious) on 10Feb2021, chills (chills) (non-serious) on 10Feb2021, fever (pyrexia) (non-serious) on 10Feb2021. The outcome of the events aches and chills were reported as recovering. The outcome of the event fever was reported as not recovered.

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.

She had no appetite; She was very tired; a headache and an upset stomach; vomiting; a headache and an upset stomach; sore arm at the site of the injection; This is a spontaneous report from a contactable consumer reported that: A 77-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot Number: EL3302; Expiration Date: 31May2021) as single dose for covid-19 immunization. The patient medical history was unknown. The patient's concomitant medications were unknown. Caller is calling to see if anyone experienced a reaction like a week after having the first COVID shot. She says she didn't give it a thought because it had been a week, but her friend today suggested maybe she was having a delayed reaction. She received the shot on 25Jan2021, says she only had the sore arm on 26Jan and it was only at the site of the injection like a regular shot, and then last Monday evening 1Feb2021, she started getting headache and the next morning she felt miserable. On 02Feb2021, she had an upset stomach and was vomiting. She was very tired and that went on for a couple days. She couldn't get off the couch. She had no appetite. Gradually she got a little better and she texted the doctor's office they suggested she go. they could make her an appointment 25 minutes away to get a COVID test. She was not feeling like driving or riding in the car to get it. Or they suggested that she quarantine for 10 days which is what she has been doing. She is feeling just about back to herself, but she was curious if that could have been from the shot or maybe she just had some other bug. She thinks she was 143 last time a few months ago. The upset stomach and vomiting last also on the 03Feb which made the headache better. She says headache is gone but her head still feels little not quite itself, but the headache is gone. She says the upset stomach and vomiting have recovered completely. The tiredness is ongoing but is much better. She has not had anything else happen and she has had not been around anybody with who was sick unless they were asymptomatic and that would have been only a very few people. She wants to know if it is possible that the vaccine caused a side effect to show up 8 days later. She does not see NDC on her vaccine card. She provides lot number expiration from her vaccine card. Outcome of the events headache, tiredness, she had no appetite were recovering. Vomiting and upset stomach were recovered.

Experienced soreness at injection sight, slight headache, fatigue, chills, weakness in legs, indigestion (sour stomach). I was diagnosed with having Covid-19 on Nov. 9, 2020. I had a mild/moderate case which lasted over 2 weeks. After receiving my first dose of the vaccine in the morning, I started experiencing the same symptoms (in the evening) that I had when I had the actual virus. One week later, I'm feeling better.

Slurred speech, extreme confusion and disorientation, headache, blurred vision. Symptoms of mild Demetia increased to meditate to severe dementia in a matter of hours.

Extreme Fatigue -falling asleep whenever I sit down up to 20 hours in one day. Memory loss including names of medications and exercises which I have been doing 2 times daily for back problems for the last 5 months. Gout type pain for a couple hours, which started and stopped suddenly!

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.

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.

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.

Vomitting, loss of appetite, very tired and disoriented 3/21/2021. Very low appetite 3/21/2021 - 3/26/2021

chills, headache, fatigue, shortness of breath, heaviness on chest for 2-3 days and shortness of breath and heaviness on chest is ongoing

Woke up with headache, sweats, chills, joint pain, and low grade fever. Stayed in bed for a day and a half the took it easy for the next two days. Back to normal the following day (Saturday).

Decedent received first Covid-19 vaccination on 03/16/2021, has not been feeling well the past week. This past week the decedent stated she had been more tired and was experiencing shortness of breath.

Patient admitted to hospital with altered mental status and fever. Found to meet SIRS criteria by recurrent fever and tachycardia, but no white count and otherwise hemodynamically stable. Urine cultures and blood cultures were drawn and did not demonstrate growth. Body imaging was done without e/o of infection. Patient started improving 1 day after admission (2 days after the second Pfizer COVID vaccine) without much intervention save for supportive care (antipyretics, antiemetics, etc.)

12 hours after fits vac red blood blister on nose; flattened next day but came back at about 36 hrs. Chest rash 36 hours after vac and last through night. 12 hrs after 2nd vac stomach upset and lose bowels; 2nd, 3rd and 4th day much fatigue sleeping 14 hours out of 24 hrs; went away after 4th day.

On March 1, I developed bed-shaking chills, fever to 101 and diarrhea lasting for several hours. Resolved without treatment.

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,

Community member, Dose #2 During post vaccination observation, lightheaded & elevated HR to ED with headache & anxiety, improved & discharged to home

Some fatigue; This is a spontaneous report received from a contactable consumer, the patient. This patient reported different events with two vaccine doses: This is the second of two doses. This 77-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9810), via an unspecified route of administration in the left deltoid arm on 19Feb2021 from 08:15 to 08:30 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was not taking any concomitant medications. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration on 26Jan2021 08:15 (at the age of 77-year-old) as a single dose for COVID-19 immunization, then on 31Jan2021 she became totally nauseous, light headed, very chilled, extremely tired, very cold and felt asleep under warm down quilt until 14:00 (total 13 hours) with recovery without any hospital admission and treatment received. On 25Feb2021, the patient experienced some fatigue for one day. The clinical outcome of some fatigue was resolved in Feb2021.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021093680 Same patient, different drug (first vaccine dose) and events.

Patient potentially received higher than the recommended 0.3ml dose of the Pfizer vaccine. As of Sunday 4/4, patient reports soreness at injection site and fatigue.

Rash on hands, arms, face. Also, with the first shot had a dry cough about a week after the vaccine. Feeling like i might be getting a cough now.

04/07/2021 5:25 am woke up with tight chest and shallow breathing. Immediately took asthma medication. I usually take 2 puffs of Advair and 2 puffs Xopenex an hour or two after waking (daily treatment. I don't wake up with a tight chest. 6:30 a.m. breathing has normalized. Have headache, earache and some nasal drainage.

Couldn't breathe/shortness of breath; Back pain; blood pressure was high; was just sick; This is a spontaneous report from a contactable consumer. A 77-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 08Mar2021 (at the age of 77-years-old) (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood pressure abnormal, cancer in her left lung, ongoing blood cholesterol abnormal, ongoing gastric disorder, ongoing diverticulitis Verbatim: Virticulitis. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) taken for blood pressure abnormal; atorvastatin (ATORVASTATIN) taken for blood cholesterol; hydralazine taken for blood pressure abnormal; lisinopril (LISINOPRIL) taken for blood pressure abnormal from Feb2021 and ongoing; pantoprazole taken for gastric disorder from 2020 and ongoing. The patient had her first shot and after that, a week after she experienced some adverse events like back pain and sickness. After the patient started experiencing back pain, and got progressively worse, she was having problem breathing/Shortness of breath was reported. The patient was ambulanced and mentioned she was brought to the hospital/stayed with her doctors overnight due to the experiences she had. She had blood work done and based on the results, they suspected a blood clot on her lung and her CT scan did show that she did not have a clot in her lung. It was also reported that they did blood test and urine test and that all that EKG because the patient had her blood pressure gone considerably high and in the blood test. She was prescribed to take Tylenol every 8 hours and a to put a back patch on the left side of her back where she is experiencing pain. Caller did not provide if she was admitted to the hospital, or if she just stayed in the ER overnight for observation. Now, she wants to know if she will still proceed with her 2nd shot on 29Mar2021. The patient underwent lab tests and procedures which included abdomen scan: normal, no indication of blood clot on 17Mar2021, angiogram: normal, no indication of blood clot on 17Mar2021, blood pressure measurement: high, blood test: a blood clot on her lung on Mar2021, computerised tomogram: normal, no indication of blood clot on 17Mar2021, covid-19: negative on 17Mar2021, x-ray of pelvis and hip: normal, no indication of blood clot on 17Mar2021. Therapeutic measures were taken as a result of back pain (back pain). The seriousness of the events back pain and Couldn't breathe/shortness of breath was hospitalization. The outcome of the events back pain was recovering. The outcome of the other events was unknown.

fever up to 101 F; itching; severe head and spine pain; severe head and spine pain; Extreme fatigue; Erythematous; Loss of voice; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in left arm on 12Feb2021 12:30 as single dose for covid-19 immunisation. Medical history included psoriatic arthropathy, basedow's disease, psoriasis. Concomitant medications included levothyroxine sodium (SYNTHROID) (MANUFACTURER UNKNOWN); estrogens conjugated, medroxyprogesterone acetate (PREMPRO) (MANUFACTURER UNKNOWN). The patient previously took fentanyl and experienced drug hypersensitivity and bnt162b2 (product=COVID 19, brand=Pfizer BioNTech, lot number=EL9262, administration date=21Jan2021, administration time=04:00 PM, vaccine location=Left arm, dose number=1). On 13Feb2021 06:30 and experienced fever up to 101 f, itching, severe head and spine pain, severe head and spine pain, extreme fatigue, erythematous. On an unspecified date in Feb2021, patient experienced loss of voice. 18 hours post injection, severe head and spine pain, extreme fatigue, fever up to 101 F persisting 36 hours. Loss of voice 96 hours later, intermittent fever. Erythematous, hot area, raised (size of an orange) with itching in the area persists. On 13Feb2021, the patient underwent lab tests which included body temperature: up to 101 fahrenheit (intermittent fever). The patient did not receive any treatment for the events. The clinical outcomes of the fever up to 101 f, itching, severe head and spine pain, severe head and spine pain, extreme fatigue, erythematous, loss of voice were recovering. No follow-up attempts are possible.

SEVERE HA , DOCTORS SAYS SE HAD ISCHEMIC STROKE , NOT SURE IF RELATED TO THE VACCINE What happened as a result of the adverse event? SAW DOCTOR

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.

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.

Stated that she felt like she had flu; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9810), dose 1 via an unspecified route of administration on 03Feb2021 as single dose for COVID-19 immunisation. Medical history included blocked subclavian artery and arteriosclerosis, both were diagnosed seven years ago and are ongoing. The concomitants medication was not provided. About 36 hours after vaccination, the patient experienced all side effects except fever and nausea, felt like she had flu and severe allergic reaction. The patient ended up going to bed and taking fluids for two days. The patient had flu for a few days and slept for a few days. She was back to normal. She is scheduled for a second shot in couple of weeks. She wanted to know the likelihood is great for this to happen again so that she can mentally prepare. The patient stated that the majority of the side effects in her age group did increase after the second dose. She stated one should not get the Pfizer-BioNTech COVID-19 Vaccine if had a severe allergic reaction after a previous dose of this vaccine. The reporter assessed the event as non-serious. The outcome of the events was unknown.

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.

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.

Received vaccine 3/4/21 second dose. On 4/2/21 got soar throat and both glands swollen. Called doctor right away and was given prescription for Z Pack. Felt better in 2 days.

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

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.

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

site pain; tiredness; headache; unwell/sour gut; chills w/out fever; 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 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in left arm on 10Feb2021 at 11:45(at the age of 77-year-old ) as a single dose for COVID-19 immunization. Patient medical history included asthma, some mild arthritis, osteopenia. Concomitant medications included Mometasone Furoate(ASMANEX) (MANUFACTURER UNKNOWN), Esomeprazole sodium (NEXIUM) (MANUFACTURER UNKNOWN), Montelukast sodium (SINGULAIR) (MANUFACTURER UNKNOWN), (FLUTICASONE), vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 16Feb2021, on the 2nd and 3rd day, the patient experienced site pain, tiredness, headache. On the 6th day, the patient experienced chills without fever, tiredness, unwell/sourgut, headache. The outcome of the events was Recovered on an unknown date.

fatigue; 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), via an unspecified route of administration on 29Mar2021 (Batch/Lot Number: ER8733) as single dose for COVID-19 immunization. Medical history included diabetes mellitus and hypertension. The patient took the first dose of BNT162B2 (Batch/Lot Number: ER8733) on 08Mar2021 for COVID-19 immunization and experienced achy in arm. Concomitant medications included ongoing metformin (strength: 1000 mg) taken for diabetes mellitus; ongoing sitagliptin phosphate (JANUVIA, strength: 100 mg) taken for diabetes mellitus; indapamide (strength: 1.25 mg) taken for hypertension; lisinopril (strength: 40 mg) taken for hypertension. The patient experienced fatigue on 30Mar2021. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Severe fatigue after first dose. 1 week after 2nd dose 3/18/21, developed worsening fatigue with 43% blasts on peripheral CBC indicating a transformation from CMML to AML.

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.

Patient tested for COVID-19 PCR on 4/10/21; >2 weeks after fully immunized w/ Pfizer on 3/18/21. Patient had cough, myalgia, anosmia, dysgeusia, fatigue. Hospitalized 4/14-4/19/21. Received Remdesivir and monoclonal antibody treatment.

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

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.

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.

Throbbing headache; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 77-years-old female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: EM9810) via an unspecified route of administration at arm right on 04Feb2021 evening as single dose for COVID-19 immunization. Medical history included hypothyroidism, High Cholesterol and allergic to Penicillin. Patient could had not taken Sulfa or steroids and she non-drinker. It was reported that patient had swelling of hands with penicillin when she was a child. She developed oral ocular dermatitis caused by the steroid in Flonase. That was diagnosed by dermatologist. It had been about 3 years now. Concomitant medications included levothyroxine (LEVOTHYROXINE), 75mcg once daily for thyroid disorder, monascus purpureus (RED YEAST RICE) and cinnamomum verum (CINNAMON) for blood cholesterol. It was reported that patient took lots of vitamins and she did not like taking medications because she was allergic to all sorts of stuff, including statins, but had no trouble with any vaccine or flu shots which she was took in October. On 05Feb2021, the patient awoke because experienced throbbing headache in the middle of the night. Patient took a Tylenol 500mg (acetaminophen, lot no. 8JE2158A, Exp. Date Jul2020) once at 6am, after about 12 hours after the shot. The event subsided a little, but it was still there. She said it was rampant. Life had been on hold and she wanted to go back to normal life. The outcome of the event was not recovered.

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.

Tiredness/was in bed most of the time for two days, but was up some. She was awfully tired; slept a lot; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 15Jan2021 (Batch/Lot Number: EL8982) as single dose for covid-19 immunisation.The patient medical history was not reported. It was reported that she is on high blood pressure medication. It was reported that she had chemo years ago. She dont have no product name or NDC/Lot/exp to provide. The patient's concomitant medications were not reported. On an unspecified date the patient experienced tiredness/was in bed most of the time for two days , but was up some. she was awfully tired and slept a lot. The events were considered as non-serious. She had first dose of COVID vaccine on 15Jan2021. She was in bed most of the time for two days, but was up some. She was awfully tired. She guesses she slept a lot. This was from 2PM to 9PM. It was reported that tiredness, she didn't pay too much attention to when it started. Forgot what time of the day it was. She did ok up until she went to bed and then slept. She slept a lot the next day. The COVID vaccine is the first shot she has had a problem with. The outcome of the events was unknown.

3/8/21 ED: c/c of SOB x 2 days. Pt c/o diarrhea. Pt states that she received the 2nd pfizer vaccine 2 days ago. O2 at triage was 96% on RA. She was seen in this facility Saturday 3/6/21 for HA. CTA and labs unremarkable. She reports persistent HA, though improved when compared to Saturday. Reports multiple episodes of NB diarrhea. No other medications or treatments tried. In the ER she was seen to have a significant leukocytosis with wbc in 26, AKi with SCr in 2.7, thombocytopenia. Ordered CT scan which showed congestion and LLL pna and trace effusion. ID, Cardiology and Nephrology consulted. Treated for acute kidney injury with hyposmolar hyponatremia, on tolvactam, Sodium 133, trending up. Treated for sepsis with gram negative bacteremia d/t e.coli, completed ceftriaxone course. Treated for essential hypertension, elevated troponin, BP now controlled. Discharged home on 3/17/21

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.

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.

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.

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

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.

Headache; Backache; fever; nausea; exhaustion; sore throat; dry cough; bronchitis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9263, Expiration date not reported), via an unspecified route of administration in left arm on 31Jan2021 09:30 (at the age 77-year-old), as a single dose for COVID-19 immunization. Medical history included Type 2 Diabetes. The patient previously took ondansetron (ZOFRAN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included insulin degludec (TRESIBA), insulin aspart (NOVOLOG), Bupropion, Alprazolam and Estradiol. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 14:00, the patient experienced headache, backache, fever, nausea, exhaustion, sore throat, dry cough and bronchitis. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was tested for COVID twice by covid test type: one Nasal Swab test, on 08Feb2021, the result was negative. The treatment received for the events were antibiotics and steroid. Outcome of the events were reported as recovering.

sx: headache the day after vaccination and local pain in the opposite shoulder (right shoulder) from where she was vaccinated (left arm). headache resolved with apap dosing. but rt shoulder pain/tightness has persisted on and off for the last 9days. pt said she is not using apap on regular basis. and also admitted to doing light gardening during this time.

This 77 year old female received the Covid shot on 4/1/21 and went to the ED on 4/11/21 and admitted on 4/12/21 and again to the ED on 4/24/21 with the below listed diagnoses and died on 5/9/21. J18.9 - Pneumonia, unspecified organism

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.

afib and tachycardia for 3-4 days; afib and tachycardia for 3-4 days; chills; lethargy; kind a brain fog; felt like I had a cold spent 2 days feeling like that; She has as temperamental immune system. She is extremely sensitive. She reacts to everything; This is a spontaneous report from a contactable consumer (patient) via Medical Information. A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 72-year-old for COVID-19 immunisation. The patient medical history included temperamental immune system (she is extremely sensitive. She reacts to everything). The concomitant medications were not reported. on an unspecified the patient experienced atrial fibrillation (AFIB), tachycardia, chills, lethargy, brain fog, felt like i had a cold spent 2 days feeling like that, hypersensitivity. Therapeutic measures were taken as a result of AFIB, tachycardia. The outcome of events was unknown. The course of events was as follows: On an unspecified she had reacted to the first vaccine: the first day she was fine. The next day she had chills, lethargy, kind a brain fog, felt like she had a cold and spent 2 days feeling like that. On Day 3 she had AFIB and tachycardia for 3-4 days saw the heart doctor and got medicine for that. She had a temperamental immune system. The stress test was super important. She was wandering if she had the Pfizer vaccine a week after the stress test. She got it at the university, and she wandered if they were restricted to give it to her a few days after my scheduled date: They wanted to rule out blockage in her heart. She was having a test done around the same time as the 2nd Pfizer vaccine. She wanted to know if she could get the 2nd dose of the Pfizer vaccine later/ a week after the stress test. She wanted the vaccine, it was important. On 04May21 she was going to have a dye based test checking your heart, a stress test. The stress test was scheduled the same morning as her 2nd dose of the Pfizer COVID vaccine. She was advised to consult with your doctor or pharmacist for further guidance.

headache; sweats; Chills, so bad that my teeth were rattling; fever; muscle aches; exhaustion; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration, administered in left arm on 10Feb2021 02:15 PM (Batch/Lot number was not reported) as single dose for covid-19 immunization. Patient was non-pregnant at the time of vaccination. Medical history included neuropathy and diabetes. The patient's concomitant medications was not reported. On 11Feb2021 patient experienced chills, fever, headache, muscle aches, sweats and exhaustion which lasted until Saturday 13Feb2021 and then patient was fine for several days but on the night of 17Feb at 8PM, again with the chills, so bad that patient's teeth were rattling, headache and sweats all this lasted until 3 AM then patient had aches and exhaustion for several days". The treatment was not received for the adverse events. Outcome of headache and sweats was recovered on an unspecified date and rest of the event was recovered on 13Feb2021. No follow up attempts are needed. No further information is expected.

Legs swelled up really bad ; it left blotches in my leg; Legs swelled up really bad ; it left blotches in my leg; Fever; Bladder infection; UTI; He gave me some medications and it is helping the rash; stomach even swelled up; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 77 years old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, for COVID-19 immunization, dose 1 on 17Jan2021 at age of 77 years old. On 23Feb2021, the patient experienced legs swelled up really bad it left blotches in my leg and she went to the doctor, she had fever, bladder infection and Urinary tract infection (UTI). The legs swelled up real bad, her thighs from the waist, she just swelled up everywhere. Her stomach even swelled up but the right leg mostly. She experienced the blotching, it looks like a birth mark on my right leg and the left leg. It is blotchy, looks like a birth mark on the legs. The right one got really big. She did go to doctor and he said it was not a blood clot. He said people are getting swelled up with rash, some people are having rashes and swelling. Treatment included the physician gave her some medications and it is helping the rash and "cephalexin 500 mg, 3 times a day" for the UTI. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Patient was feeling a little tired; 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) at single dose, on 10Feb2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient was feeling a little tired. Clinical outcome of the adverse event was unknown at time of this report. The case was assessed as non-serious. The lot number is not available despite follow-up attempts made. Follow-up attempt have been completed and no further information is expected.

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.

Headache, lethargy, nausea, fever for first three days then rash covering all extremeties and abdomena nd chest

headache; Exhausted; Chills; Joint Pain; achy pain; Flu; Eye floaters; Feeling Strange; Nauseaus; Dizzy; This is a spontaneous report was received from a contactable consumer or other non hcp. A 77-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 05Feb2021 14:00 (at the age of 77-year-old) as single dose for COVID-19 immunization. The patient's medical history included digestion problems, ongoing coeliac disease and allergy to gluten. Concomitant medications included vitamin b complex (vitamin b), zinc (zinc), vitamin c [ascorbic acid] (vitamin c [ascorbic acid]), colecalciferol (vitamin d [colecalciferol]), bifidobacterium lactis (Probiotic [bifidobacterium lactis]). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 05Feb2021 at 18:00, the patient was exhausted and experienced chills, headache, joint pain started in left ankle, later she had achy pains all over and felt lousy like she had the flu. The patient had new floaters in her eyes and a strange feeling in her head and was also extremely nauseous and dizzy. The patient did not take any treatment. The patient was not tested for covid prior vaccination and post vaccination. The outcome of the events was recovered on an unspecified date in 2021. Follow up attempts are completed. No further information is expected.

headache; chills; fever; sore muscles; This is a spontaneous report from contactable Consumer (patient).A 77-years-old (non-pregnant) female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: BN5318 and expiry date was not reported) dose 2 via an unspecified route of administration in left arm on 12Feb2021 12:00 (at 77-years age) as a 2nd single dose for COVID-19 immunisation and received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL8982 and expiry date was not reported) dose 1 via an unspecified route of administration in left arm on 22Jan2021 12:00 as a 1st single dose for COVID-19 immunisation. The patient medical history included AFib and latex allergy. Concomitant medication(s) included rivaroxaban (XARELTO); flecainide (FLECAINIDE); amlodipine (AMLODIPINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Feb2021 at 01:00 AM the patient experienced with headache, chills, fever and sore muscles. The patient had no covid tested post vaccination. The patient did not receive any treatment medication for the events. The outcome of the events was recovered.

Extremely sleepy; nausea; headaches; This is a spontaneous report from a contactable consumer. This 77-year-old female consumer reported for herself that she received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 10:15 (Batch/Lot Number: EN6201) as SINGLE D0SE for covid-19 immunisation. Medical history included diabetes mellitus, rheumatoid arthritis, pulmonary hypertension, fibromyalgia, dermatitis contact, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included chlorthalidone (CHLORTHALIDONE) taken for an unspecified indication; lansoprazole (LANSOPRAZOLE) taken for an unspecified indication; macitentan (MACITENTAN) taken for an unspecified indication; rosuvastatin calcium (ROSUVAS) taken for an unspecified indication, start and stop date were not reported. The patient previously took betadine [povidone-iodine] and experienced drug hypersensitivity, spironolactone and experienced drug hypersensitivity. On 08Feb2021 15:00 the patient experienced extremely sleepy, nausea, headaches. Extremely sleepy into the 3rd week now. Sleep night and day naps. Used 5 night hours, no day naps. 3rd week. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was not recovered.

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.

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.

Office Visit 3/27/2021 T, PA-C COVID-19 Dx Cough ? Diarrhea ? Fatigue ? Covid-19 Screening Reason for Visit Progress Notes , PA-C (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 3/27/2021 ? ? Signed Cosigned by: MD at 3/28/2021 9:14 AM Expand AllCollapse All MDM Nontoxic-appearing 77-year-old female presents with 5 days of URI symptoms. Rapid Covid testing house was positive. Patient has had 1 dose of Pfizer SARS-CoV-2 vaccine and is due for his second and final in 1 week. Patient was given strict supportive care and isolation instructions. She is to follow-up with her PCP today when she leaves to discuss monoclonal antibody infusion. ED precautions reviewed in detail with patient. 1. COVID-19 was seen today for cough, diarrhea, fatigue and covid-19 screening. Diagnoses and all orders for this visit: COVID-19 - POCT COVID-19 Antigen RN Registered Nurse Progress Notes Signed Encounter Date: 3/30/2021 Signed Hide copied text Hover for details Patient is here for MAB Infusion Consent for infusion prior to this visit reviewed and verified. O2 sats > or = 90% Signs of potential reaction reviewed with patient. Tolerated IV start and MAB infusion without complication. Pt has access to pulse oximeter and thermometer for home monitoring Provided fact sheet for patients, parents and caregivers- Emergency Use Authorization of BAM for Coronovirus Disease 2019 for pt to review. Discharge instructions reviewed. Patient denies any questions

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.

in the last hour that she has had a headache and diarrhea twice; in the last hour that she has had a headache and diarrhea twice; This is a spontaneous report from a contactable consumer (patient) reporting about herself. A 77-year-old female patient (77 years age at vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, Expiration Date: 2021), via an unspecified route of administration, in left arm on 28Jan2021 at 13:40 as (0.3 ML) single dose for COVID-19 immunisation. The patient's medical history stated that she dropped weight before the vaccine. She usually had diarrhoea that it depended on what she ate. In the last hour following vaccination (28Jan2021, afternoon), the patient experienced a dull headache and diarrhoea twice. She stated that sometimes it was normal to have diarrhoea for her, but she did not know the reason as it started so bad that afternoon. The patient said that she took Pepto-Bismol (unspecified formulation) for her diarrhoea that she normally used to take, as treatment medication. The outcome of the event headache was reported as recovering while the outcome of the event diarrhoea was reported as unknown. Information on the lot/batch number has been requested.

She got her vaccine, a little diarrhea, a slight headache, foggy brain, overwhelming fatigue, slight nausea for a few days and then it stopped. She is having these symptoms again, and is having this for the third time which started a few days ago with the same reactoin, plus muscle weakness, just feeling sick like, crappy feeling.

brain fog, dizziness, strange sensation in sinuses difficulty in concentrating, difficulty focusing eyes when reading, eye events such as "flaters" flashing at outer sdges of eyes, exhaustion and needing more sleep than usual

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

ear feel like they were popping/ears pop when she swallows; Sore throat; Throat was swollen; fever; diarrhea; chills; 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 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL9261, Expiration Date was not reported), via an unspecified route of administration on 25Jan2021 (at the age of 77-year-old) as 1st dose, single for covid-19 immunisation. Medical history included covid-19 from Sep2020 to an unknown date, breast cancer female (Breast cancer with lymph node removal) from 2012 to an unknown date, lymphadenectomy (Breast cancer with lymph node removal), type 2 diabetes mellitus, blood pressure abnormal. Concomitant medications included metformin hcl (METFORMIN HCL, 500mg) taken for type 2 diabetes mellitus from 2006 and ongoing; simvastatin (SIMVASTATIN, 20mg) taken for blood pressure abnormal from an unspecified start date and ongoing. It was reported that, patient got the Pfizer COVID-19 vaccine on 25Jan2021 and on the next day (26Jan2021), she had a fever (101.1F), diarrhea, and chills. It reminded her of her having COIVD-19 back in Sep2021. She said she took some Tylenol and She put compresses on her forehead and neck, then her temperature went down to 99F. She didn't have chills. She did have diarrhea on Tuesday as well, her temperature remained on 99F and caller had no fever since then but on Wednesday (27Jan2021), She was fine on Wednesday. Then on Thursday, her throat was sore. Her throat was still sore when she swallows. She has not had trouble breathing, her throat was swollen and her ear feel like they were popping. Her ears will pop when she swallows. She said it was uncomfortable. It was just annoying. She checks her temp, pulse, and o2 intake every day. They are good. She heard them say something about 3 when they were talking about the dose. She had COVID back in Sep2020. It was a mild case. She had diarrhea and a temp. That was it. She wasn't sure if she could get it again, or if she could carry it and give it to someone. That was why she decided to get it. She also had breast cancer, and her lymph nodes removed in 2012. She was due for her second shot 16Feb2021. She taught school for 32 years. She has a doctor's appointment tomorrow (04Feb2021) and will have some bloodwork done. She said she monitored her pulse (heart rate was on 70s) and oxygen level (94 or 97) and said they were good. She wanted to know recommendations for the second dose considering this AE. The patient underwent lab tests and procedures which included body temperature was 99 on an unspecified date, body temperature was 101.1 on 26Jan2021 , body temperature was 99 on 27Jan2021, heart rate: 70s/good on an unspecified date (She said she monitored her pulse (heart rate was on 70s/She checks her temp, pulse, and o2 intake every day. They are good) , oxygen saturation: 94or 97/good on an unspecified date (oxygen level (94 or 97) and said they were good/She checks her temp, pulse, and o2 intake every day. They are good), sars-cov-2 test: positive on Sep2020. Therapeutic measures were taken as a result of fever (pyrexia). The case was non serious. The outcome for the event fever was recovered on 27Jan2021, for events chills and diarrhoea was recovered on 26Jan2021, not recovered for events ear feel like they were popping/ears pop when she swallows, Sore throat and unknown for other events. Follow-up attempts are completed. No further information is expected

Vaccine on Wednesday 4/28/21. Started to have mild headache, nausea, generalized malaise and chills on Thursday 4/29/21. Seemed to then improve but then became lightheaded and dizzy. Came to emergency room 5/2/21 at 1000. BP stable at 136/69, O2 sat 99% on room air. No significant findings on blood work (CMP, CBC, Troponin, BNP, TSH all within normal limits). Chest Xray was normal. EKG showed atrial fibrillation with rapid ventricular rate in the 150s. She was given IV diltiazem and her heart rate was controlled. She was admitted to the hospital for observation and conversion from IV to PO diltiazem. She declined oral anticoagulation. She was discharged home on 5/3/21 and instructed to follow up with her PCP and was to see cardiology.

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.

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.

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.

nauseated; upset stomach; itching all over her body; threw up at breakfast; Headache; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EL9265, Expiration date: unknown), dose 1 via an unspecified route of administration on 28Jan2021 as 1st dose, single for COVID-19 immunization. Medical history included ongoing blood pressure and acid reflux. Concomitant medication(s) included vitamin c, VITAMIN D3, calcium, zinc, blood pressure medication and acid reflux medication. The patient did not want to take the vaccine but her son insisted she took it so she went with him. The patient reported that she got the first dose of the vaccine and she did not think she paid much attention that day. The first day the patient threw up at breakfast and felt real nauseated then continued to have nausea with an upset stomach all day long and she did not know if that was making her headache or what, but she was nauseated all day long. The second day, she had a stomach upset. She went out that day and came home. She could not remember if she ate anything or not but then the next day she got nauseated with an upsets stomach. One night, she had itching all over her body then she feels like just blah. She took a Benadryl toward the morning because she could not stand the itching and thought if it was some type of allergy or something, maybe it could cut it down and she finally got to sleep. She wanted to know about the second dose because she heard a lot of people were super sick with the next vaccine and if she was having problems right now, whether she should take the another one. She saw the date range 17Feb2021-24Feb2021 and COVID 19 vaccine. She regularly took a blood pressure medication and an acid reflux. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

she may have gained weight; nausea; a real bad headache; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 77-year-old patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 02Feb2021 as 2nd dose single and had previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 12Jan2021 as 1st dose (at the age of 77-years-old) for COVID-19 immunization. Patient had no other vaccines on the same day as her COVID vaccine. Patient medical history and concomitant medications were not reported. Patient woke up this morning (03Feb2021) with nausea and a real bad headache and wanted to know if she can take Tylenol but she is wondering if it is contraindicated with the product. Patient stated that the first dose did not do anything to her like this second dose has done. Patient further stated that she believes her symptoms are listed on her fact handout sheet as known side effects of the product. Patient lab data and procedures included patient weight as 265 or 270 pounds, she believes she might have gained weight during the pandemic. The outcome of the events was unknown. Follow-up (03Feb2021): This is a follow-up spontaneous report from a contactable consumer. This 77-year-old female consumer reported that included patient's complete age, description about the adverse event with the onset date.

sleep for two days; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 77-years-old (non-pregnant) female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration in arm right on 03Feb2021 13:45 as unknown, single dose for COVID-19 immunization. Medical history included subclavian artery stenosis from an unknown date and unknown if ongoing, arteriosclerosis from an unknown date and unknown if ongoing and allergy to penicillin. No other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for covid post vaccination. The patient concomitant medications were not reported. On 05Feb2021, 36 hours after the injection and the patient experienced all the side effects except fever and nausea and needed bed rest and sleep for two days and was worried about what will happen with the second dose of the vaccine. Will she get all the unpleasant effects again and could it be worse enquired. The treatment was not received. The outcome of the event was recovered. Information about lot/batch number has been requested.

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.

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.

Her first dose was 21Jan2021 and the second dose was 14Feb2021. This past Saturday, 15May2021 she was diagnosed with Covid-19; Her first dose was 21Jan2021 and the second dose was 14Feb2021. This past Saturday, 15May2021 she was diagnosed with Covid-19; Headaches; Her nose was running continuously; When she got the headaches, she felt like her head was pounding or coming through her ears in her head; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 14Feb2021 probably around 1 or 1:30 (Batch/Lot Number: EN5318) as single dose, dose 1 via an unspecified route of administration, administered in arm right on 21Jan2021 10:00 (Batch/Lot Number: EL1283) as single dose for COVID-19 immunization. Medical history included atrial fibrillation (A-fib) has been diagnosed for approximately 2 years. Concomitant medications included metoprolol taken for atrial fibrillation for a couple of years; apixaban (ELIQUIS) taken for blood thinner for a couple of years; lovastatin; vitamins. Vaccine was injected by a nurse. No AEs following prior vaccinations. The patient has had both doses of the vaccine. Her first dose was 21Jan2021 and the second dose was 14Feb2021. This past Saturday, 15May2021 she was diagnosed positive with COVID-19 by a COVID-19 rapid test. No other tests reported. Patient stated the case she has was not too severe. She got a knee injection on the same day of the vaccine. She was not sure what medication it was but she thought it was cortisone. She stated it appeared her immune system didn't react properly so it made her feel she was not properly protected by the vaccine. Patient added that she had a couple of injections into her knee and she did not know if that can have any effect on the vaccine and break down immunity. Patient asked if she can get an additional shot since this one obviously did not work. Patient added that she did not want to get COVID19. She wanted to find out why did it breakdown, why did her immunity breakdown. Secondly, once this is all over, can she get another shot? She is not going to get comfortable based on what is going to happen. Diagnosed with COVID19 after receiving vaccines, patient stated that she had a few symptoms and was shocked it came back positive. She had no fever, she had no nausea. She had headaches, chills, and a really bad cough in 2021. Her nose was running continuously in 2021. When she got the headaches, she felt like her head was pounding or coming through her ears in her head. It was like something she never experienced before and it was out of the ordinary. She thought it was something more than an ordinary cold so she went and got tested. Patient was taking paracetamol (TYLENOL) and she took some Coricidin for treatment, and stated this was an over the counter decongestant. AEs did not require a visit to Emergency Room and Physician Office. Patient just went to the medical building. Information on Lot/Batch number was available. Additional information has been requested.

Slight fever -- 100.9; extremely tired; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Pfizer and expiration date: not reported), via an unspecified route of administration, administered in arm left on 27Feb2021 09:45 (at the age of 77 years) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications (No other medications in two weeks). No other vaccine in four weeks, no covid prior vaccination and not covid tested post vaccination. No known allergies. Previously, patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE (Solution for injection, Batch/Lot Number: EN6201 and expiration date: not reported), via an unspecified route of administration, administered in arm left on 06Feb2021 09:15 (at the age of 77 years) as single dose for covid-19 immunisation. The patient experienced slight fever - 100.9, was extremely tired and had diarrhea on 28Feb2021 at 06:00. No treatment given for any event. The patient's lab data included fever: 100.9. The Outcome of the events was recovered. No follow-up attempts are needed. No further information is expected.

Horrible feeling; Blood pressure goes high; Joint hurt; Fever/ very low temperature; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A 77-years-old female consumer (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient previously took tylenol as per her common sense and epipens (double dose) for swollen mouth and lips (due to a cleaner) two months ago. Concomitant medications were not reported. As per the description, it was reported that the patient was scared because she didn't had anyone. She was hesitated to get a vaccine. She experienced some reactions after her 2nd dose of the Pfizer vaccine. Her joint hurt and she was in a bad situation. She had a very low temperature than the normal temperature, blood pressure was high when she got upset. She was very angry that she had fever and had nobody to ask a question. She reported that no one told her about a high fever (100.4) or to go to the hospital. She said it was not worth it for her to get a fever. She reported the information on the paper was very vague and not clear, she felt horrible as she suffered and wanted to let know. She wanted to complain that the temperature of fever was not written and none of those were approved. She was asked to contact her local doctor. That was the most horrible experience for her. The patient underwent lab tests and procedures which included blood pressure measurement as high, body temperature as and 100.4. The outcome of all the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

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.

case hospitalized due to COVID. Case in the ICU with pneumonia and ARDS and currently on a ventilator.

sore shoulder; Shoulder discomfort (Musculoskeletal discomfort); sleepy; This is a spontaneous report from non-contactable consumer via two different programs. A 77-year-old female consumer reported that she received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) dose 2 via an unspecified route of administration on 08Apr2021 (at the age of 77-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. On 02Apr2021, female patient initiated Tymlos (abaloparatide) 80mcg daily subcutaneous injection, Lot# unknown, for the treatment of osteoporosis.Medical history included , intervertebral disc protrusion from an unknown date and unknown if ongoing verbatim: 4th disc slipped on 5th disc and pinched a nerve, and surgery (unspecified) , nerve compression from an unknown date and unknown if ongoing verbatim: 4th disc slipped on 5th disc and pinched a nerve, and surgery (unspecified). Surgery from an unknown date and unknown if ongoing verbatim: 4th disc slipped on 5th disc and pinched a nerve, and surgery (unspecified), tooth injury from an unknown date and unknown if ongoing. verbatim: Teeth were clear after one year of therapy. The patient's concomitant medications were not reported. Historical drugs included Fosamax (alendronate sodium) and Forteo (teriparatide). Relevant surgical, social, or substance-usage history was not provided Relevant concomitant medications were not provided. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on an unknown date as single dose for covid-19 immunisation. The patient experienced dizziness (start/stop date 02Apr2021, duration just a few minutes also reported as less than an hour), product use omission (did not use Tymlos on 08Apr2021) (start/stop date 08Apr2021), and intentional product misuse (took two doses of Tymlos on the same day) (start/stop date 09Apr2021). No treatment was reported. 09Apr2021, patient experienced sleepy and shoulder discomfort (musculoskeletal discomfort). On an unspecified date, patient had sore shoulder. Diagnostic tests included a bone mineral analysis; per patient, results were 3.6 (units not reported). The action taken with Tymlos was dose not changed. The outcome of events was unknown. Additional information has been requested. Information on the lot/batch number has been requested.

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.

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.

Soreness at injection site (3 days) Swollen lymph glands (2 days) Lethargy (2 days) Fever spikes (day following shot) Brain fog (2 weeks) Achiness in shoulders & neck (2 days) Diarrhea (2 weeks - ongoing)

This is a spontaneous report from contactable consumer reporting for herself. A 77-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6206) on 12Mar2021 at 10:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included COPD, Lupus, Contrast media allergy. The patient received first dose of BNT162B2 (UEN 6201) on 19Feb2021 at 14:00 on left arm. Concomitant medications included metoprolol, prednisone, amlodipine. On 13Mar2021 at 02:00 the patient experienced pyrexia, nausea, vomiting, diarrhea. No Treatment was received for the event. At the time of the reporting the patient had not yet recovered from the events. No follow-up attempts are possible. No further information is expected.

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.

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.

2/22/2021 - Tested positive for Covid 3/9/2021 - found down at her SNF, taken to ER. complains of lower back pain, left hip pain, bilateral knee pain, low O2 sat Dx: Aspiration pneumonia of both lower lobes (HCC), *Left lower lobe pneumonia, History of COVID-19, Urinary retention, Diarrhea C diff negative. 3/22: placed on palliative care after speaking with family 3/23: Expired

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.

Diarrhea; Upset stomach; Low gradefever; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: en6208), via unspecified route of administration in left arm on 16Mar2021 at 11:45 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), depression and fractured arm and leg. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: em9810), via unspecified route of administration and in left arm on 05Feb2021 at 11:00 as a single dose for COVID-19 immunisation. The patient had no known allergies. Concomitant medications included LIPITOR, gabapentin (MANUFACTURER UNKNOWN), mirtazapine (MANUFACTURER UNKNOWN) and blood pressure medications (unspecified); all for unknown indications from an unknown date. Prior to vaccination, the patient had no symptoms associated with COVID-19. Since vaccination, the patient was not tested COVID-19 positive. On 16Mar2021 at 15:00, the patient experienced diarrhea, upset stomach and low grade fever. Therapeutic measures were taken as a result of diarrhea, upset stomach and low grade fever and included treatment with IMODIUM AD and TYLENOL from an unknown date. The clinical outcome of diarrhea, upset stomach and low grade fever were not resolved. No follow-up attempts are possible. No further information is available.

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.

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

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

Head pain; Pain on jaw bone; Pain on both sides of the nose; Pain in neck and shoulders; Froze up her muscles; Physical therapist told her she may have tendinitis in her head/brain; Pain in neck and shoulders; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 26Feb2021 (age at vaccination 77-year-old) as 2nd dose, single for covid-19 immunization. Medical history included fall. Patient stated that in the early 2000s she had a fall as a result of an allergic reaction to a prescription medication and hit her head on the kitchen floor and ended up in the hospital after fall, no further information provided by the caller about what prescription medication this was, allergic reaction to a prescription medication and pacemaker. The patient's concomitant medications were not reported. The patient previously took first dose of BNT62B2 for COVID-19 Immunization. Patient stated she had her second dose of the Pfizer Covid 19 Vaccine on 26Feb2021 and had some side effects and she assumes they were from the vaccine. On 27Feb2021, patient experienced head pain and pain on jawbone. Stated she continued to have pain in her head, neck, and shoulders. She went to her primary care and an ear, nose, and throat doctor. Says she had lots of sinus problems, lots of allergies, and was highly sensitive to medications. On an unspecified date in Feb2021, one night, all night, she had pain on both sides of her nose. States she continued to have serious head pain, pain in neck and shoulders, froze up her muscles, she stated the Covid Vaccine froze up her muscles. She said the physical therapist said she possibly has tendinitis in her head and said physical therapy has been helping, it was not just a minor, dull feeling in her head. Patient stated she was in Physical Therapy because they were working on her muscles and said she goes every Tuesday and Thursday. Said they were working on trying to unfreeze her muscles. Patient stated that she sees an allergist once a year. Patient said she wonders if she got an overdose of the vaccine due to her sensitivity, weight, and size. Patient stated she needs someone with technical expertise. Since she has a pacemaker she went and saw her cardiologist to see if there was any impact on her pacemaker. The cardiologist found no changes. She was concerned going forward how much of a risk was she at of getting Covid 19. Patient stated that the ear, nose, and throat doctor did a scan of her sinuses and an x-ray of her head. Patient stated she cannot have an MRI due to her pacemaker. The patient underwent lab tests and procedures which included scan of her sinuses: unknown, scratch test positive: unknown in an unspecified date in 2005, x-ray of her head: unknown. The outcome of the events was unknown. Information on Lot/Batch number has been requested.

sneezing; runny nose after getting the first dose of Pfizer COVID-19 vaccine/her nose was just running and dripping; I have allergies but never have one like that; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9263, NDC number and Expiry Date: Unknown), via an unspecified route of administration in Arm Left on 02Feb2021 (Tuesday) at 14:30 as a 1ST DOSE, SINGLE for covid-19 immunisation (age at vaccination was 77 year old). The patient's medical history included allergies. Concomitant medications included montelukast 10mg at bedtime she had been on it a while and fexofenadine hydrochloride (ALLEGRA), 180mg in the morning (It is over the counter. Count Size: 70 tablets. Lot number: 20F211C, expiry: Nov2022), both were taken for allergies. She didn't take Allegra Tuesday morning when she went to get the vaccine, but she did take it yesterday (on unknown date). History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional Vaccines was Administered on Same Date of the Pfizer Suspect. Prior Vaccinations within 4 weeks and AE) following prior vaccinations was None. On 02Feb2021 the patient experienced sneezing and runny nose after getting the first dose of Pfizer COVID-19 vaccine. "her nose was dripping, dripping, dripping quiet a lot but this morning it's better but she was still sneezing (On 02Feb2021). She had allergies but never have one like that on an unspecified date in Feb2021. Patient wanted to know if she can receive the second dose of the vaccine. Upon follow up patient reported that, she got her shot on 02Feb2021. That night she started sneezing. Then her nose was just running and dripping. It is a lot better this morning (date unspecified). It just drips a little. She wanted to know if that mean she is allergic to COVID 19 vaccine and she should get the next one or not. She called the doctor because she was going to ask him because she took allergy pills. She had never had that reaction before where her nose runs and runs. The sneezing and the nose running and dripping has improved. She had only sneezed once this morning. It is not running as bad today (date unspecified). Events did not require a visit to Emergency Room or Physician Office. Outcome of the sneezing and runny nose after getting the first dose of pfizer covid-19 vaccine/her nose was just running, and dripping were recovering, and she had allergies but never had one like that was unknown. Follow-up attempts are completed. No further information is expected.

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

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.

cramps in stomach; chills; aches in joints; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 08:45 (at the age of 77-year-old), as a single dose for COVID-19 immunisation. Medical history included osteoporosis, hypertension, restless legs and low thyroid. Concomitant medications included levetiractan (MANUFACTURER UNKNOWN), ropinirole (MANUFACTURER UNKNOWN), baby aspirin (MANUFACTURER UNKNOWN) and valsartan (MANUFACTURER UNKNOWN) taken within last two weeks of vaccination for an unknown indication from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 18Mar2021 at 12:00 AM, the patient experienced chills, aches in joints, cramps in stomach, and diarrhoea. The patient did not receive any treatment for the adverse 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 chills, aches in joints, cramps in stomach, and diarrhoea was recovering. No follow-up attempts are possible. No further information is expected.

Flu-like symptoms; headache; Body aches; fatigue; in bed all next day; Left arm swollen; itchy at injection site; This is a spontaneous report from a contactable consumer. A 77-year-old non-pregnant female consumer (Patient) reported that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 30Jan2021 at 02:15 AM (at 77-year old) on left arm at dose 1, single for COVID-19 immunization. The medical history of the patient included that she was tested covid-19 positive. The patient had no allergies. The patient's concomitant medications were not reported. Patient had not received any Other vaccine same date and had not received other vaccine same date product. It was mentioned that patient got no other vaccine in four weeks and no medications in two weeks. On 30Jan2021, the same day patient had itchy at injection site; Monday he was site still itchy. On 31Jan2021 at 12:00 hours the patient experienced flu-like symptoms, headache, body aches, fatigue, in bed all next day after shot and his left arm was swollen. On 08Feb2021 the nasal swab covid test was done for which results was unknown. The patient was scheduled for 2nd shot on 20Feb2021. The outcome of injection site itchy was not recovered and outcome of other events flu-like symptoms, headache, body aches, fatigue, in bed all next day after shot and his left arm was swollen was unknown. No follow-up attempts were possible; information about Lot/batch number could not be obtained.

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.

Diarrhea; Very tired/tiredness; This is a spontaneous report from two contactable consumers (patient's husband and patient). A 77-years-old female patient received first dose of BNT162B2 (FPFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot Number: EM9810) via intramuscular administered in left arm on 06Feb2021 at 10:00 as dose 1, single (at the age of 77-years-old) for COVID-19 immunization at Clinic. No additional vaccines administered on the same date of Pfizer vaccine. Medical history included ongoing Chronic obstructive pulmonary disease (COPD) diagnosed probably 4 or 5 years ago; and also developed a blood clot 4 or 5 years ago; both from an unknown date. Concomitant medication included WARFARIN 3.5 tablet, by mouth, daily taken as blood thinner for blood clot. The patient not received any other vaccine within 4 weeks prior Vaccination. On 07Feb2021 (Yesterday), patient was very tired and on 08Feb2021, she experienced diarrhea which started early the morning. No Investigation Assessment. No Emergency Room or Physician Office visit and no relevant tests. It was reported reporter did call the physician's office to let her know he was experiencing these side effects. She did too and had the same thing happen. He clarifies further her, and her husband had the whole thing. The caller declined to compete a report on either the physician or the physician's husband. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

I'm freezing and all kinds of things on a daily basis; pain; chills; headache; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9265 and Expiration date: unknown), via an unknown route of administration, in left arm on 03Feb2021 (at the age of 77-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension, internal bleeding and take special medications to keep her CBC where it needed, thyroid cancer, cancer, cholesterol, rheumatoid and osteoarthritis from an unknown date, she bruise all the time, depression and PTSD since her husband has committed suicide. Concomitant medications included methotrexate taken for neoplasm malignant; folic acid taken for blood cholesterol, start and stop date were not reported. Patient took chemotherapy for rheumatoid arthritis. She was feeling like she had covid all her life because she was in pain, has chills and freezing and all kinds of things on a daily basis. She bruise all the time, but did not get bruise from the vaccine. The first dose of event was very uneventful. Patient had intramuscular injection before and the pain she had was just terrible. She don't want any more pain in her life. She wanted to ask what are the risk of bleeding with the vaccine and also wish to know the information about risks and blood thinners was in the fact sheet so she could read about that before getting the shot. She goes back on 21Feb2021 for the second dose. She made it clear that, she has a autoimmune disease of rheumatoid arthritis and did not want to take a shot in the muscle. She would have an adverse in next two weeks. She does not told anything about the second dose. The man that gave her the shot said that the side effects depended on her immune system. It could be nothing. She has a headache from holding the phone. She wanted to ask if she takes a blood thiner when she got the vaccine. She does not take a blood thinner. She has a internal bleeding and has to have routine CBC's. As long as her count is at a certain point she does not have to have an operation. The patient underwent lab tests and procedures which included full blood count: unknown results on an unknown date. Outcome of events was unknown. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

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.

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.

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.

got sick; she got little bit cough and begin Flu; she got little bit cough and begin Flu; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Mar2021 as Dose 1,Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient got sick and was not able to get the 2nd dose on time. She plans to take it in August. She was supposed to get her second dose but she got little bit cough and she got to begin Flu or something she didn't care, now trying to get her second dose vaccine. I wanted to know if the event dose she is planning for second dose in Aug2021, my question is, if I needs to restart whole process or just need to take the second dose. She is asking if that would be okay or should she repeat the 1st dose. The outcome of the events illness, cough, influenza was unknown. Information about lot/batch number cannot be obtained. Additional information has been requested.

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.

loss of appetite; loss of taste; headaches; fatigue; This is a spontaneous report received from a contactable consumer or other non hcp (patients son). This consumer reported for mother. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) (age at vaccination was reported as 77 years) via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number not reported) as single dose for covid-19 immunization. Patient's Medical History including any illness at time of vaccination was reported as none. The patient's concomitant medications were not reported. The patient experienced loss of appetite, loss of taste, headaches, fatigue on an unspecified date. Additional context reported as report that his 78-year-old mother experienced side effects after administration of the fist dose of Pfizer Covid-19 Vaccine. The patient has already gone to the physician for the management of the symptoms. The patient was dosed with first dose of Pfizer Covid-19 Vaccine less than 2 weeks ago but does not have the actual date of administration or the Pfizer Covid-19 Vaccine Lot and things like that. The patient underwent lab tests and procedures which included chest x-ray: not have pneumonia on 09Jul2021. She does not have pneumonia. The clinical outcome of the events was not recovered. Information on the lot/batch number has been requested

Pericarditis S/S: actue chest pain or pressure, Chest pain made worse bu lying down, deep inspiration or cough, Pain Hx from 3 providers Patient presents for CP that started on Sunday night. Worse with inspiration states she feels like she has to breath shallow. Reports at 3:30 this morning pain was worse. Developed this retrosternal pleuritic chest pain late Sunday that has worsened over the course of the day yesterday and early this morning. She describes it as radiating up into her neck at times. No shortness of breath or cough. The pain encompasses a large area of her central chest which can radiate up the center of her neck. It is worse with deep breaths but not worse with walking. Initial Admit for Chest pain, developed A Fib during ED admission. Seen by Cardiology. Admitted 2/16-2/18. Neg CT pulm angiogram. Disch Diag including Cardiology 1. Pleuritic chest pain, 02/17/2021 2. Atrial fibrillation, 02/18/2021 3. NSTEMI (non-ST elevated myocardial infarction), 02/17/2021 4. Pleural effusion, bilateral, 02/18/2021 Pt readmitted 2/19/21. Troponin neg at that admit. D Dimer, Quantitative: 2.62 mcg/mL FEU Troponin I: <0.030 ng/mL BNP: 227 pg/mL Cardiology consult 2/20/21 called it pericarditis On 3/10/21 admitted for salicylate toxicity (on ASA for AFib) and ED provider stated that 2/16/21 admit for chest pain states that cardiology note at 3/10/21 stated the prior admit included diagnosis of pericarditis

Feeling tired. After about six weeks, rapid decline with COPD - trouble breathing and heart palpitations.

Swelling; Redness; Vaccination site pain; Tiredness; Rash 4 inch circle since shot; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP0955) via an unspecified route in the right arm on 25Mar2021 at 12:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient included osteopenia, sulphur and shellfish allergy. The past drug history of the patient included gabapentin started on an unknown date for an unknown indication. The patient received lovastatin (MANUFACTURER UNKNOWN) started on an unknown date within 2 weeks prior to the COVID-19 vaccine for an unknown indication. 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 the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route in the right arm on 04Mar2021 at 12:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Post the vaccination, the patient was not tested for COVID-19. On 26Mar2021 at 00:00, the patient experienced swelling, redness, pain at injection site (vaccination site pain), tiredness and rash of 4-inch circle since the shot. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events swelling, redness, pain at injection site (vaccination site pain), tiredness and rash of 4-inch circle since the shot was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.

Patient presented to the ED and was subsequently hospitalized for acute respiratory failure with hypoxia and pneumonia within 6 weeks of receiving first dose of covid vaccination.

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.

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.

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.

Slept all day; very tired; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6199), via an unspecified route of administration, administered in Arm Left on 07Mar2021 08:00 as dose 1, single, and via an unspecified route of administration, administered in Arm Left on 28Mar2021 (Lot Number: EP6955) as dose 2, single for Covid-19 immunisation (Vaccinated at 77years of age). Medical history and concomitant medications were not reported. No family medical history relevant to adverse events reported. The patient slept all day, very tired on 09Mar2021. Patient reported that she received her first dose on a Sunday(07Mar2021) and was tired on Tuesday(09Mar2021) and just slept all day and by the 3rd day(10Mar2021) she was up and fine. The patient said that the tiredness was with her first dose. She stated that the tiredness was just for 1 day. Her vaccines were received 2 weeks apart and thought they were in May. Patient clarified that they were actually 3 weeks apart and she received them in Mar2021. NDC number of Pfizer Covid-19 Vaccine was Unknown. AE(s) did not required a visit to Emergency Room or Physician Office. There was no Prior Vaccinations within 4 weeks. There was no AE(s) following prior vaccinations. No relevant tests. The outcome of events were resolved on 10Mar2021. Follow-Up (14Jul2021): Follow-up attempts are completed. No further information is expected.

July 28 2021 woke up with slight cough , sore throat, also had some knee pain July 29 woke up 4;30 am With Excruciating knee pain and swollen knee , could not walk . My husband and son In law had to help me get up Also had sore throat and laryngitis Not sure if the above is related to my second shot 7/22/21 or not

7/20/21 1st Covid vaccination (pfizer) appt was at 10:30 actually received injection approx 11:15 am. around 6 hrs later, left arm/injection site began to ache. THEN, approx 8:00 pm, (approx 9 hrs after injection) I experienced slight shortness of breath (sob) plus some fatigue, headache, dizziness. Was able to go to sleep--after a while. Next morning, 7/21/21 sob more noticeable. Didn't do my regular 3-4 mile walk. By afternoon (7/21/21) great fatigue, greater headache, dizziness and shortness of breath stronger. In middle of day I went to bed and slept 4 hrs. --to nap like this...very rare except when I had Covid, late 2019/early 2020. Following evening, 7/22/21, approx. 8:00 PM, because that day had been free of sob, I took dog for walk...only reached l/8 mile, or less, because sob returned, in a stronger manner. I had to rest before able to walk back home. By 9:15 pm, same evening (7/22/21), sob worsened--although only sitting at computer. Husband found my 2019 rx of "albuterol sulfate" inhaler...( 90 mcg per puff, take 2 puffs back to back) something I've NEVER used before. This was prescribed because in 2019 because of extreme sob, now considered to be symptom of Covid. The inhalant helped. July 27, 2021, I had to use inhalent again--sob.

Pt received first dose on Monday 7/26/21 and returned to pharmacy on Thursday 7/29/21 reporting she had a sore throat the night she got her vaccine. She now has redness/red-like and warm-to-the-touch circular appearance about 3 inches below her injection site (may be cellulitis). Pt denied she did not have other symptoms like throat swelling, itching, lip swelling, etc. She will take benadryl and ibuprofen to reduce the redness/inflammation. She will also keep the area clean by washing with warm water and soap. She was advised to contact MD if she does not see it going away or symptoms persist or new symptoms occur.

PATIENT REPORTS APPROXIMATELY 5-10 MINUTES AFTER RECEIVING VACCINE TO LEFT ARM THAT "MY HEAD FELT WEIRD AND I GOT A PAIN TO MY LEFT EAR FOR A SPLIT SECOND." SHE REPORTS IT CAME AND LEFT VERY QUICKLY. UNABLE TO DESCRIBE WHAT THE HEAD FELT LIKE OTHER THAN WEIRD. REPORTED FEELING COMPLETELY NORMAL AFTER OCCURANCE

"Pfizer-BioNTech COVID-19 Vaccine" 12/29 patient developed SOB, fever tmax 103 degrees F, diaphoretic, dry heaves all started approximately 16 hours after vaccination given. patient then transferred to Hospital for further treatment and observation. 12/30 seen at injection site- erythema, swelling, warmth and tenderness Discharged back to home on 1/1 with RX for cephalexin to treat cellulitis of injection site

from about 9 p m on 01/04/2021 to 10 a m on 01/05/2021 I felt very sick with headache, sore throat and All-over aches

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.

During 15 minutes post observation period, patient c/o mild posterior headache and neck pain. BP 166/103, HR 124, SaO2 99%. Pt taking HCTZ antihypertensive but missed medication today. Patient received IV hydration at treatment center.

Injection site pain,tiredness,headache,muscle pain,chills, joint pain,nausea,feeling unwell, temperature 99.6

7 am. 1/13/2021 increased poly arthritis joint pain Chills Headache Malaise . Tylenol every 6 hours 1/14/2021. headache , malaise, hyper skin sensitivity on back arms; felt like sunburn 1/15/2021 increased pain on skin especially on back headache increased malaise ; joint pain subsided, Malaise and headache has lasted for 3 full days

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.

Admitted to hospital 1/14/2021 with acute mental status changes, hypoxia, pneumonia (previous positive COVID 12/18/2020) ICU 1/14/2021-1/16/2021, currently hospitalized PCU level of care

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.

vaccine on 1/20/21. Fatigue, confusion on morning of 1/21/21. Pt's family concerned could be due to vaccine vs infection vs dementia.

began to ache 2 pm of day of vacination, could not sleep. shooting pain ears, hands, head, much worse than 1st shot

rash which gotten bigger on the chest/rash around the side it has gotten bigger and now she is having them in other areas/rash around the left side on the arm; Very tired/Tiredness; Itching; 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, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 07Jan2021 in the left arm at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) which she uses a nebulizer for this. There were no concomitant medications. The patient previously received first dose of BNT162B2 (lot number: EJ1685) on 18Dec2020 in the right arm for COVID-19 immunization. The patient reported that she was very tired, tiredness started on the same day as she received the second dose of the vaccine on 07Jan2021. The patient also developed a rash which gotten bigger on the chest, a rash around the side it has gotten bigger and now she was having them in other areas 3 days later (10Jan2021). The patient further explained that it also developed rash around the left side on the arm. The patient was using Cortizone cream over the counter and it relieved itching (started in Jan2021) but it didn't totally take it away. She still felt tired today. The patient had no positive tests for COVID and no antibody test before the vaccine. She had no issues with vaccine in the past. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

18:10 Pt. reports to observation nurse throbbing (R) eye stabbing pain, (R) sided headache. 10 minutes post vaccine. EMS evaluation. B/P 125/71, HR 88, 99% Sat O2, 2 hours post prandial BG 149. (R) sided headache and (R) sided eye pain worsens, pt. agree to transport to local area hospital.

started the 2nd day after the shot. I was slight head head, stomach, achy all over. This week i have just started to feel better

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.

This is a spontaneous report from a contactable consumer who reported for herself. A 78-year-old female patient received her single first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3246), at right arm, 17:00 on 08Jan2021 for Covid-19 immunization. The patient's medical history included hyperlipidemia, hypothyroidism, osteopenia, skin cancer, osteoarthritis right hip and had known allergies to zocor, lipitor, latex, fluorouracil, imiquimod, travis. The patient normally had low blood pressure and pulse. Patient had no Covid-19 prior to vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) and pravastatin sodium (PRAVASTATINE SODIUM ACCORD). Patient had no other vaccines within four weeks. 08:00 on 10Jan2021, the patient had increase in B/P, pulse, and developed headache and light headed. The patient had healthcare professional office/clinic visit. No treatment was received. The patient had not tested Covid-19 prior to or post vaccination. The outcome of the events was not resolved at the time of reporting.

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 no: EL0142), via an unspecified route of administration on 12Jan2021 at a single dose on the right arm because she doesn't want to get Covid. Medical history includes the patient being sick before she got the shot, she had the flu since an unspecified date in Dec2020 during Christmas time. She didn't feel well before. She thought it was Covid and her friend was also sick that time and did have Covid. She stated that her own symptoms were like the flu, no fever, just regular flu symptoms. There were no concomitant medications. The patient reported that got her first vaccine this past Tuesday, 12Jan2021. She has been fine, but her arm is quite red since an unspecified date in Jan2021, and was tender since 13Jan2021 but was not hurting. When she took off the band aid the next day to take a shower, everything was okay. On Thursday, 14Jan2021 when she woke up she noticed redness and it was tender. SHe added that her arm is quite red and tender to the touch. She was asking if she should put hear or ice on it or just leave it alone. She wanted to know if this was normal. She stated that she has had a dull headache since an unspecified date after receiving the vaccine. Her arm was also swollen on an unspecified date after receiving the vaccine and sore. The patient wants to know if there are any recommendations for treatment. The outcome of the event vaccination site erythema was not recovered, the outcome of the event vaccination site pain was recovering the outcome of the other events was unknown.

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.

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.

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.

Patient reported that after a couple of hours of receiving the covid vaccine, she became dizzy, nauseated, and lightheaded. She reported her blood pressure was low 80/60 and her heart rate about 100. She rested and her pressure came up. Then she reported a couple hours later she felt that way again while walking around house. She sat down and felt better. Then around 6p symptoms came back and she also had a headache and a little shortness of breath. She then decided to go to the ER.

Flu-like symptoms while in bed. Fever, sweating, nausea, fatigue which lasted from midnight till morning.

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.

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

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.

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.

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

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.

ASTHMA WAS UNDER CONTROL PRIOR TO THE VACCINE. AFTERWARDS, MORE DIFFICULT BREATHING WHEN EXERCISE OR BUSY. INCREASED MUCUS. ADDED MUCINEX TO MEDICATIONS. AS OF 2/1, MY ASTHMA IS STILL WORSE THAN IT WAS BEFORE. hOWEVER THE FIRST 2 DAYS OF THE REACTION WERE MORE SIGNIFICANT THAN NOW.

not feeling well that day; The next morning I was tired because I didnt get good sleep the night before; severe chills; nausea; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283; expiration date: unknown), intramuscularly left deltoid on 12Jan2021 10:50 at a single dose for prevention (covid-19 immunization). Medical history included cystitis interstitial and headache. There were no concomitant medications. The patient didn't receive other vaccines in the last 4 weeks. The patient reported that she had her first dose on 12Jan2021 around 10am and she experienced severe chills where she could not get warm and nausea the night of 13Jan2021, about 10pm. It lasted approximately 8 hours. She probably had a temperature, but she was shaking so much, she did not check. She could not get warm. The next day, she was tired, and probably because she could not sleep the night before. The tiredness was back to normal on 14Jan2021 at 8pm. She was awake the whole night until 8am. The chills stopped and she was very, very tired. Around 8pm on 14Jan2021, she felt like her normal self and it was amazing. She was not feeling well that day (unspecified date). She is due for her second dose on 02Feb2021. She added that she had severe chill ("couldn't get warm") and nausea then the next morning, she was tired because she didn't get good sleep the night before and then felt like herself the following day. The nausea stopped 8 hours afterwards. The tiredness was back to normal on 14Jan2021 at 8pm. She mentioned that she was treated for interstitial cystitis before she took the vaccine. She began to experience a headache prior to receiving the vaccination and called the hotline to see if it was COVID. They did not want to test her since she did not have any other symptoms. She got tested for COVID on 18Jan2021, and it came back negative. She inquired if she can take 25mg of diphenhydramine (BENADRYL) and acetaminophen (TYLENOL) prior to her receiving her second dose to prevent side effects. Treatment was received by the patient. The outcome of the event feeling unwell was unknown while the outcome of the other events was recovered on 14Jan2021 20:00.

Pt alerted circulating RN that she was feeling tightening in her throat. Pt mentioned that she wanted to walk to the room because she was not feeling dizzy. Pt was asked about any heart problems and she responded that she has a pacemaker. Pt was taken to a private room for further monitoring and observation. Patient asked about history of this problem, to which she replied that this has never happened before. Patient mentioned that her allergic reactions typically consist of a rash or hives. Vitals were taken and recorded. BP was initially high at 180/80. Pt declined admission to the emergency department. Pt awake and alert, good historian. No difficulty speaking or breathing. No shortness of breath, denied chest pain, reported "tightness" and pointing to neck area. Pt described, "feels like I have phlegm there." Denied water. No drooling & speech clear. No numbness to extremities or aching to shoulders, no nausea, no dizziness. Pt ok to sit up and accepts water at 11:38AM (20 minutes following initial incident), denies food and juice. Swallows multiple sips without difficulty. Pt denied throat tightness or pain. EMTALA Form completed. Pt education performed regarding potential side effects of COVID-19 vaccine and sources of information going forward. 11:43AM pt feels comfortable to walk and wants to go home. Pt discharged to home ambulatory, stable VS and states understanding of plan of care after COVID 19 vaccine today.

Immediately after receiving the vaccine had heart palpitations while sitting down for the 15 minute wait time. She thought it would be temporary and go away, but did not. She came home, and it was still happening, still having them. She talked to her daughter and went to the ER. They did an EKG and blood work for fear of having a heart attack, all was negative. Didn't do anything more for her. After 3 hours and moved to a chair and then it suddenly stopped. She did have this reaction for about 5 hours. Still feeling tired but not sure if it was from weather or stress itself.

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.

Headache; Chills; cognitive confusion, serious and unprecedented; extreme fatigue; weakness; nausea. These symptoms have continued to the present, 2/6/2021.

Patient complained of difficulty swallowing, tingling feeling in her tongue. She initatally took 50 mg of benedryl, and after 15 more minutes, she continued to have the same symptoms, and in addition was breathing more labored, was having a harder time swallowing, and complaining of feeling dizzy and a headache. She then received an Epi Pen, was placed on oxygen, used her Xopenex inhaler, and EMS was called. She was then transferred to the ED for continued monitoring.

AMS-Fever-UTI-myoclonic jerks-unresponsive <6hrs post 1st covid vaccine. AMS-UTI- post 2nd covid vaccine

1040 The patient received the COVID vaccine. At 1055 the patient began to complain of a dry scratchy throat. Zyrtec 20 mg given per MD. Patient monitored for another 45 minutes. Patient reported feeling better. Symptoms resolved. Discharged home per MD

Off and On High Fever (102.7) with sever chills, nausea, fatigue lasting six days. Chills stop, low grade fever continue for three more days, rash appears on my neck, back and front of my body. Doctor insist I get a Covid 19 test. It came back negative. This was my first pfizer vaccine.

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.

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.

double vision, little dizzy, headache - yesterday had her 2nd vaccine SYMPTOMS DURATION: 2 days. Patient states she got her first COVID vaccine on 2/5/21 and had a slight headache but no other symptoms. Today, she was sitting the car when she started to have double vision. She reports dizziness/lightheadedness that is moderate. Patient states the double vision isn't everything but random things and at random times today. Denies dehydration, fever, or injection site abnormalities. No headache today. Reports that last week at her PCP's office her BP was slightly elevated and she thinks her BP may be elevated right now but does not have a cuff with her to check. Went to the Emergency Department on 2.6.21 - admitted overnight until the 7th. DETAILS OF HOSPITAL STAY: DX: Diplopia [H53.2] Blurred vision, bilateral [H53.8] HOSPITAL COURSE: 1. Double vision post COVID vaccine. Unclear etiology or if related to vaccine reaction. Resolved. CVA ruled out. Could be migraine associated. Advised patient to talk to PCP about migraine prophylaxis and see ophthalmology as outpatient. 2. HTN 3. HLD Advised patient not to drive till cleared by ophthalmology Inpatient workup included myasthenia gravis panel which is still pending The patient is a 78-year-old right-handed woman who received her first Pfizer COVID vaccination February 5. This morning she developed double vision. Images were horizontal she does not know if they were binocular or monocular. She saw couple with 1 child and it appeared that they had 2 children. She looked at her son and saw 2 heads on 1 body. She saw 2 traffic lights. Each time she saw diplopia, it lasted for maybe 1 minute, and after blinking it went away. The double vision was not associated with headache, facial numbness or weakness, numbness or weakness in her extremities, speech change or imbalance. She recovered from each episode. She has had torn retina twice in each eye. Those were each associated with flashes of light in floaters. She did not have a fever today. She has never had double vision before. Review of systems: She admits to a history of headaches. She said she had catamenial headaches and sinus headaches.

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.

accute hypothermia (93.3 degrees),pounding headache, pain from base of neck all down spine. temp came up gradually in 2 hrs. head and back pain continued 2 days. Temp continued low 95.5 and up every am and came to normal. returned to without head pain 5 days later. still have lingering symptoms thru today, ie temp is normal than low, than normal after arising in morning, still have moderate back pain and slight headache but nothing debilitating now. never had anything like this before. quite healthy and athletic ie running half-marathons til covid hit.

Flashes of lights in my eyes, burning pain in my legs, my ankles were on fire. Totally fatigued, could hardly walk and had to walk with a cane and hold onto wall. Just plain pain all over, I felt nauseated but never threw up. I took anti-nausea pills and pain pills.

This is a spontaneous report from a contactable consumer (patient) from the Pfizer-sponsored program. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3248, expiration date: Apr2021) via an unspecified route of administration in left arm on 24Jan2021 13:30 at single dose for COVID-19 immunization. Medical history included lupus from 26Feb2019 and ongoing, biopsy done/diagnosed 26Feb2019, known to be cutaneous, unknown if systemic lupus erythematosus (SLE)-not officially diagnosed as SLE yet but keep monitoring to see, patient sister has possibly compromised immune system with lupus; ongoing allergies, included ongoing allergies/reactions to insect stings, wasp stings-that was first reaction 8-9 years ago-carried EpiPen since then, dye in a contrast medium for CT scan in Sep2020; had serious surgery, 2 subsequent surgeries, couldn't remember anything within last couple of years, 1st surgery: fall or beginning of 2019; scheduled to have surgery to repair abdominal surgery as a result of all the other stuff, had to cancel it and reschedule for spring due to rash, rash diagnosed as lupus; compromised immune status; respiratory illness; genetic / chromosomal abnormalities; endocrine abnormalities (including diabetes) and obesity; overweight. No allergies/reactions to vaccines historically. Concomitant medications included ongoing hydroxychloroquine (Zydus Pharmaceuticals, Lot number: E003901, Expiry date: 31May2022, NDC: Unknown, UPC: 4181077301, repeatedly verified dispensed in standard amber/orange pharmacy bottle; but had manufacturer label on bottle-no NDC) for lupus. The patient previously used epinephrine (EPIPEN, reported as Epi-pen) first/only time 2020: maybe summer/fall/Sep2020 for anaphylactic reaction to yellow jacket sting. On 24Jan2021 around 2:30pm she had onset of extreme fatigue (just like kind of an overwhelming fatigue). She had not even discussed having the vaccine with her PCP and did not consider extreme fatigue to be serious or something she needed to contact the doctor about. She ended up getting home, eating something, going upstairs and going to sleep (went "straight to bed"). She slept really well. Outcome improved, she was better, ok. She wondered if this was an extreme reaction to the vaccine or was this normal because this was the first shot, she read that the second dose creates even more pronounced side effects. She was asking if that was a normal reaction and can she expect that after the second dose? No vaccines administered on same date of the Pfizer suspect. The adverse event did not result in Emergency Room or Physician Office, and patient was not hospitalized. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The outcome of the event was recovering.

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.

Mild headache; chills; some joint pains; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL8982), via an unspecified route of administration in the left arm on 26Jan2021 11:15 at 0.3 mL, single for COVID-19 immunization. Medical history included hypertension and known allergies to penicillin. The patient is not pregnant at the time of vaccination. The patient has no COVID prior vaccination. The patient has not been tested for COVID post vaccination. Concomitant medications included atenolol, chlorthalidone, felodipine, losartan, and potassium acetate (POTASSIO ACETATO). On 26Jan2021 15:00, the patient experienced mild headache, chills, and some joint pains. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.

she had quite a rash, it was red, right where the injection was made; it was warm; her arm was hurting a bit; slight headache; This is a spontaneous report from a contactable consumer (patient) and contactable physician. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263), via an unspecified route of administration at arm left on 22Jan2021 at single dose for COVID-19 immunization. The patient medical history included COVID-19 (with symptoms: terrible headache, cough, shortness of breath for good 6 weeks and fatigue) from Nov2020 to an unknown date. The patient experienced slight headache on 23Jan2021, her arm was hurting a bit on 25Jan2021. On 26Jan2021, her arm was still sore, it was warm, she had quite a rash, it was red, right where the injection was made, the rest was more pink. The patient outcome of headache was recovered on 24Jan2021, the outcome of the other events was not recovered.

severe headache lasted almost 3 days High blood pressure with a racing heart on the third day I received a prescription from my cardioligist the next I lost my sense of taste as of 02/02/2021 (11 days) my taste has not returned

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

Severe headache, severe nausea, elevated temp 101.9, severe body aches...In bed all day, so sick just like I was so very sick when I had covid-19. 2 /13/21 woke up feeling normal.

Over a 7 day period: Severe fatigue continual, headaches mild to moderate hourly, body chills continual.

Severe chills, total body aches, nausea, headache, low grade fever 99.7. Pain at injection site. Lethargic very sleepy

Received Pfizer 1/22/2021. RNA+ 2/4/2021. S/S SOB, cough, confusion. COVID assoc. resp. failure, stage 4 lung cancer, COPD, HTN, former smoker. patient in hospice and died 2/10/2021.

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.

Vertigo, nauseous, sweaty Symptoms lasted 3 to 4 hours. Not like orthostatic hypotension when bp is low. Did not stop when sitting. Did not vomit but felt very sick. Hope it doesn't happen again.

Fever over 100 degrees, muscle aches and joint pains, general weakness and malaise, at approximately 20 hours after injection, until about 30 hours after.

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

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

My Mom had an an allergic reaction four hours after receiving her first dose of the Pfizer Covid 19 vaccine. Her face swelled up and became red....worse on the right side than the left...her eyes were swollen as well. It lasted this way for four days....it is a little better now, but her face is still a little swollen (seven days after shot). She had a headache on and off and felt tired (which we understand is not an allergic reaction, but rather an immune response). Her family physician suggested taking antihistamines before her second shot. Needless to say, we are apprehensive about what the outcome from the second shot will be like for her.

Exp. Date 6/30/2021. Unable to lift my left arm higher than my shoulder, swelling of upper left arm, tiredness.

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.

Chills; Fatigue; Headache; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at Left arm on 30Jan2021 17:45 at single dose for covid-19 immunization. Medical history included allergies. The patient had allergies to medications, food, or other products. 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. Concomitant medications were yes but unspecified. The patient received other medications within 2 weeks of vaccination. The patient experienced chills, fatigue and headache, all on 30Jan2021 19:30. Since the vaccination, the patient had not been tested for COVID-19. The outcome was unknown. The seriousness from reporter was non-serious.

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.

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

1. Immediately had very unpleasant metallic taste in mouth. 2. Five to ten minutes after injection had very severe headache. After returning to car, took 2 extra strength (500 mg) rapid release Tylenol. Headache lasted 5/6 hours. 3. Soreness around injection site for 2 1/2 days.

Patient admitted following a syncopal episode which was found to be likely due to dehydration, orthostatic hypotension, and post-operative pain after ORIF.

Approx. 6 h after injection, chills; followed by headache, nausea, aching, vomiting and diarrhea. Duration approx. 24 h.

On 2/19/2021, 78yr old female with history of asthma, diverticulitis, GERD, hiatal hernia, HTN, and hyperlipidemia was administered second dose of COVID-19 Pfizer vaccine 0.3mL in left deltoid (LOT # EN6201). Patient has several documented allergies including dextromethorphan (anaphylaxis), guaifenesin (anaphylaxis), olmesartan (itching), erythromycin (unknown), hydrocodone (unknown), atorvastatin/pravastatin/rosuvastatin (muscle pain), codeine (throat swelling), shrimp (hives, itching). Patient received first dose of COVID-19 Pfizer vaccine on 1/27/21 without any documented issues. Patient initially tolerated injection without incident and was sent for post-injection 15min observation. During 15min observation period, patient became dizzy, diaphoretic, nauseated, and unable to walk with steady gait, hypertensive and endorsed hives. EMS called and patient sent to ED. During initial presentation to ED, BP 180/80, HR 85, and 97% on RA. Patient given Benadryl 25mg PO and ondansetron 4mg IVP at 2055. 1L LR bolus given at 2059. BP lowered during ED observation (BP 160/80 on 2/20 at 0442). Acetaminophen 650mg PO given at 0442 prior to discharge. Patient discharged home in stable condition ~ 0500 on 2/20 with plan for patient to follow up with outpatient provider. EpiPen was not prescribed at discharge. No update to EPIC allergies noted at this time. Of note, reporter notes unable to check POC BG at clinic (glucometer unavailable). Patient has no history of diabetes, but noted that has similar "episodes" with low BG. EMS checked BG (POC = 144).

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).

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

Nausea/sick to her stomach; Headache; stomach is upset; not feeling great; dizziness; Vertigo; This is a spontaneous report from a contactable consumer. A 78-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) on her left arm, via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. It was reported that the patient got shot on Friday and last night she woke up with vertigo on 25Jan2021. This morning (26Jan2021), she could not eat breakfast because she was nauseous and sick to her stomach; stomach is upset. She is walking around now and just is not feeling great. She also has a headache and dizziness. The outcome of the event nausea was recovering while unknown for the other events.

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.

Patient has episode of amnesia possibly cause by seizure. Patient also had headache, chills, fatigue.

Swelling, which is hard like an egg, at the injection site; Redness at the injection site; Very lethargic; 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, lot and expiry date unknown), via an unspecified route of administration at the age of 78 years, on 22Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus, ongoing urinary tract infection, hyperparathyroidism from 21Jan2021 and ongoing, ongoing osteopenia, ongoing meningioma, seizure from an unknown date and unknown if ongoing. The patient received the first dose on 02Jan2021. On 23Jan2021, the patient experienced swelling, which was hard like an egg, at the injection site and redness at the injection site. The patient was also very lethargic on an unspecified date. No treatment was received for the events. The outcome of the event lethargic was unknown while other events were not recovered. Information on the Lot/Batch number has been requested.

hearing totally gone/complete hearing loss in left ear; tinnitus in ears and feeling of pressure; tinnitus in ears and feeling of pressure; Didn't make a real issue out of it and thought it was just congestion; This is a spontaneous report from a contactable consumer. A 78-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 in left arm at 11:15 at single dose for COVID-19 immunisation at the age of 78-year-old. Lot number was E18982. Medical history and concomitant medications were unknown. Historical vaccination included flu in Jan2021 for immunization. On 08Feb2021, the patient woke up with complete hearing loss in left ear, hearing totally gone, tinnitus in ears and feeling of pressure. In Feb2021, the patient did not make a real issue out of it and thought it was just congestion. On 08Fb2021, the patient saw ENT. On 08Feb2021, the patient performed a hearing test: complete hearing loss. On unknown date, blood work was performed, and the results were unknown. The patient did not recover from woke up with complete hearing loss in left ear/ hearing totally gone, tinnitus in ears and feeling of pressure, the outcome of nasal congestion was unknown.

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.

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

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.

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.

Severe headache; Feeling unwell; Joint pains; Muscle pains; Difficulty breathing; Chest pain; Tiredness; She felt a "little bit of nausea, very slight"; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EL3302), via an unspecified route of administration in the left arm on 23Jan2021 11:00 at single dose for Covid-19 immunisation. Medical history included blood pressure abnormal, thyroid disorder and high cholesterol. Concomitant medications included levothyroxine, lisinopril and rosuvastatin. The patient experienced severe headache, feeling unwell, joint pains, muscle pains, difficulty breathing, chest pain, tiredness on 24Jan2021 and little bit of nausea, very slight on unspecified date in Jan2021. The outcome of headache was recovered on 24Jan2021; for difficulty breathing was recovered; for chest pain and fatigue was recovering; for other events was unknown.

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.

In addition to the expected response such as fever, chilling, fatigue , for 24 hours, I had cardiac arrhythmias (PACs) lasting 1-2 hours on February 24, 25 and 26, 2021. No atrial fib but very frequent PACs which was highly unusual for me. No atrial fib since July, 2020. Also I think the expected response was for around 24 hours. I was in the bed for 36 hours and felt fatigued from February 21, 2021 through February 26, 2021.

Neurology consult 2/13/21: This is a 78-year-old female we were consulted by Dr. for possible guillian barre s/p COVID vaccine. The patient tells me that she was in her normal state of health, and she received her 1st dose of the COVID-19 vaccineseen 7 days ago. Subsequent to that, the next day she developed chills, fatigue that continued for approximately 2 days. She states that 3 days ago, she woke up and was unable to lift her legs or get herself out of bed on her own. She felt weak in her proximal lower extremities and her trunk. She denied any bandlike sensations or paresthesias. She cannot tell me that she developed any distal lower extremity weakness initially but felt that it was the acute onset. She needed some help her out of bed when she was upright, she was able to use her walker to slowly get to the factor. She may have had some urinary incontinence, she does complain of diarrhea now. Denies any tingling sensation, no bulbar symptoms. This is a 78-year-old female who we were asked to evaluate for possible Guillain-Barre syndrome. She had acute onset of lower much greater than upper extremity weakness without any definite ascending features, of relevance, is that she received the COVID-19 vaccine 3 days prior to the onset of her symptoms. She did exhibit flu-like symptoms prior to this. Given that she does not have any specific area of intrathecal enhancement to suggest Guillain-Barre or other areas of radiculitis, I think it is reasonable to proceed with lumbar puncture to look for any other source. --Given the findings on the MRI cervical and lumbar spine including enhancement of the bilateral sacral S1 region, I would like Neurosurgery to further evaluate. -- would likely benefit from CT chest abdomen pelvis to rule out any underlying occult malignancy particularly if workup remains unremarkable. -- continue supportive care, monitor for shortness of breath, new vital capacities Patient remains admitted to the hospital with continued weakness at the time of this report

No problems on the first day. The next morning I woke with a low grade fever, chills, and a headache.

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.

Very mild soreness at the injection site; Very Mild fatigue; This is a spontaneous report from a non-contactable consumer (female patient). A 78-year-old female non pregnant patient received second dose of bnt162b2 (Formulation: Solution for injection, Lot number: em9809) via unspecified route of administration on left arm, on an unknown date at single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously took historical vaccine, first dose of bnt162b2 for COVID-19 immunization. It was reported that the patient experienced very mild soreness at the injection site and very mild fatigue on 08Feb2021. The patient administered most recent COVID-19 vaccine at doctor's office/urgent care, had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medication (unspecified) within 2 weeks of vaccination (as reported). The patient didn't receive treatment for the adverse events. The patient had not diagnosed with COVID-19 prior to vaccination and since the vaccination. It was reported that patient had no allergies to medications, food, or other products. The seriousness of the events was reported as non-serious by the reporter. The outcome of the events was reported as recovered on an unknown date in Feb2021. No follow-up attempts are possible. No further information is expected.

Headache; pains in knee and muscle above knee; pains in knee and muscle above knee; Fever; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EN5318 expiration date: 31Jan2021, via an unspecified route of administration on 31Jan2021 12:20 at a single dose in the right arm for COVID-19 immunization. The patient had no family medical history and no concomitant medications. The patient had her first dose yesterday (31Jan2021), and she had some reactions to it last night 31Jan2021, had fever, headache and pains in knee and muscle above knee. She knows some of the side effect was normal. She was wondering more so, when is it ok to take a pain reliever for it, like aspirin or Ibuprofen. She went online and it said not to take anything, so she did not. She imagined her fever went away sometime during the night, she took it (unspecified) twice last night. This morning when she woke up, she had the headache, and it's gone now. Her pain in the knee started 4 hours after the injection, it was still sore but much better. The events did not require a visit to the emergency room. The patient had no prior vaccinations within four weeks. The outcome of the event fever was recovered on 31Jan2021, headache recovered on 01Feb2021 and for events pains in knee and muscle above knee was recovering. Information on the lot/batch number has been requested.

Very dizzy (room spinning falling)/ Dizziness; Dry heaves; Briefly queasy; Brief feeling of coming down with cold; Sinus swelling; Quickly fatigued still here a week later; 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 mRNA VACCINE, lot number and expiry date not reported), via an unspecified route of administration at the right arm on 23Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included environmental allergies (many), gastrooesophageal reflux disease, atrial tachycardia, blood pressure abnormal, cholecystectomy, hysterectomy, retinopexy, cellulitis, sepsis and pneumonia from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. 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. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included diltiazem, dexlansoprazole (DEXILANT), flecainide, hctz , and triamterene. The patient previously received and experienced allergies from ciprofloxacin hydrochloride (CIPRO), cefalexin (KEFLEX), tetracycline, sulfamethoxazole, trimethoprim (BACTRIM), glycopyrronium bromide (ROBINUL), doxycycline (DORYX), loratadine (CLARITIN), tetracycline hydrochloride (SUMYCIN), lisinopril and clindamycin hydrochloride (CLEOCIN). On the day of shot, on 23Jan2021 10:15 had a brief feeling of coming down with cold. Next day on 24Jan2021, the patient experienced briefly queasy, 3rd day fine, 4th day very dizzy (room spinning falling) and dry heaves. The patient also experienced dizziness, sinus swelling, and fatigued still here a week later. She took weekly immunotherapy shots for her multiple allergies. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 28Jan2021. Therapeutic measure was taken for all the events. Clinical outcome of the events was not recovered. Information about lot/batch number has been requested.

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.

Pt received vaccine at 1414. 1430 pt started getting dizzy, b/p 142/70, p-81, 02 98%ra, r-18. 1441reports a little dizzy and now feels very tired would like to lie down and sleep. 1446 dizziness resolved cont to be tired. 1456 b/p 158/78, p-75, r-18, 02 sat 98% ra reports tired but no other issues. Instructed to follow up with MD as needed. Pt released with husband

headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: EN5318), via an unspecified route of administration at the left arm on 29Jan2021 at single dose for covid-19 immunization. She doesn't really have any other health problems or take many medications. On 31Jan2021, the patient experienced headache. They are not just little small headaches. She has taken Tylenol/ Acetaminophen for it. She will get more. The outcome of the event was not recovered.

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.

Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recipient experience an allergic reaction. They developed headache and throat closing. They were treated by EMS on site with diphenhydramine and methylprednisolone. They were transported to emergency department at Regional Medical Center. They reported itching, swelling, and tingling around the mouth. During reexamination, the patient?s symptoms did not recur and they were discharged to home. Registered 03/03/2021 3:00 PM, Discharged 03/03/2021 6:13 PM.

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.

3/1 tired and diarrhea 3/2 I was ok. 3/3 I had chills all day and I was dizzy. I was also nauseous in the mornings. 3/4 I had no nausea and no diarrhea but I had no appetite and food made me gag. still had chills and extremely dizzy. felt the same until 3/7 the chills went away. 3/8 I was and am still dizzy and I had soft stools and no appetite.

Extreme fatigue, lightheaded and dizziness, extreme joint pain, vision blurryness and sore eyes, starting Wednesday March 3rd and continuing through today Monday, March 8th. Also beginning Friday, March 5th woke up with right arm swollen just below the elbow. Not sure if any of this is related to the Covid shot or having other problems. Just noticed that my vaccine card shows Lot #EN6202 but the letter sent says Lot #EL9263, for the 2nd dose.

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.

Admitted to the hospital in observation status on 3/8/21 with chief complaint of "I don't feel well, I feel dizzy and I had a rash." Patient treated in urgent care on 2/24/21 for possible UTI and again in urgent care on 3/2/21 for cat bite and given ceftriaxone IM as well as Augmentin. Patient complains of feeling a little dizzy and not quite well, rash was fleeting but she has not been eating or drinking well since vaccination and has been having headaches since that time. She is afebrile and has no respiratory symptoms but positive covid-19 test (and antibodies). Patient did complain of nausea and dehydration. Discharged on 3/9/21.

LTC Pharmacy was notified of a potential vaccine related hospital admission on 3/8/2021. The following information was gathered from discussion with RPH at Hospital. The patient received second dose of Pfizer COVID vaccine on 2/26/2021. The patient then had nausea, vomiting, and poor oral intake. On 2/27/2021, the patient went to the bathroom and while on the toilet, had a vasovagal event which led to her hitting the side of the face while falling. Patient was then taken to the hospital for evaluation. The patient does have a pacemaker but the cause of the event was determined to likely be due to dehydration. Lab work was performed and pertinent lab values include: potassium of 3.1, SCr of 0.8, and BUN of 13. The patient received potassium supplementation and IV hydration in the hospital. Patient was discharged on 2/28/2021. Of note, the patient does have a pacemaker and a follow-up appointment with cardiology to evaluate the pacemaker was scheduled upon discharge.

History of hypertension, gout, hypothyroidism, and allergic rhinitis who started to experience nasal congestion and stuffy nose after the shot. No signs of airway issues and denies any other symptoms. Vital signs stable.

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.

flu like symptoms; fever; headache; This is a spontaneous report from a non-contactable consumer (patient herself) via a medical information team. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, received first dose Saturday. The patient experienced flu like symptoms fever, headache on an unspecified date and stayed in bed yesterday (08Feb2021). The outcome of the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

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.

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.

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.

Patient is a 78 yr/o female who IBS, HDL, GERD, gastroparesis, anxiety, depression presents to the Emergency Department complaining of fever and generalized body ache onset 3 AM this morning. She attributes it to the second Covid shot that she received yesterday. She progressively started experiencing abdominal discomfort which she attributes to gastroparesis. Reports she took Tylenol at 1 PM for body ache with no relief. She also took Zofran for nausea. She had associated diarrhea without any hematochezia. Denies chest pain but has shortness of breath. She did not check her temperature at home. States she had a fever upon arrival to the emergency department. She denies dysuria, hematuria, flank pain. Patient has a history of COVID-19 infection in April 2020.

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.

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.

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.

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.

A week later, flu like symptoms: slight fever ( 99-100)r joint and muscle aches and pains, fatigue, poor appetite, chills intermittent sharp pain jabs throughout body and head. Rx: one dose of extra str. Tylenol, inc. fluids and sleep/ rest. Feel better tonight: took a shower after 3 days and am able to eat better.

pt stated that about an hour after she got the vax she had severe headache, extremely tired and pain in right leg muscle. On 2/20/21 all symptoms were gone except the pain the the right leg between her hip and knee on the outside of the leg. On 2/26/2021 she went to the ER. They did Covid Test, EKG, Chest X-ray and blood work. All test were negative. She was released to go home. On 3/4/2021 she woke up and her right leg had turned black and blue. She call 911 and taken to the ER where they did blood test, EKG, Chest Xray, CT, Spine Xray and US to see if she had any blood clots. She did not have any blood clots and all test were negative. Pt was released to FU w/ her PCP on 3/12/21. He took more blood work. Pt was told to drink water take more vitamin D. Pt still has some pain.

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.

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.

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.

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.

measles like rash on left chest; low grade fever; chills; 2nd shot, swollen glands in neck; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: El), via an unspecified route of administration in left arm on 11Feb2021 at 11:45 (at the age of 78-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included COPD (chronic obstructive pulmonary disease). Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) as a single dose for COVID-19 immunisation. The patient did not have any known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient did not test for COVID-19 post vaccination. The patient did not receive any other vaccine in four weeks. It was reported that the patient experienced 2nd shot, swollen glands in neck on 11Feb2021 at 16:00, second day (12Feb2021), low grade fever and chills, third day (13Feb2021), measles like rash on left chest. All gone now. The patient underwent lab test and procedures which included body temperature: low grade fever on 12Feb2021. No treatment was received for the adverse events. The outcome of the events was recovered on an unspecified date in Feb2021.

Fever; Nausea; headaches; This is a spontaneous report from a contactable consumer. A 78-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: unknown), via unspecified route of administration on Left arm on 28Jan2021 09:45 at single dose for covid-19 immunisation. The patient's medical history included High Blood pressure, Obesity. The patient's concomitant medications were not reported. It was reported that patient experienced Fever, Nausea, and headaches after vaccine on 24Jan2021 08:00 AM. Other medications the patient received within 2 weeks of vaccination are blood Pressure Medication 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 for COVID-19. The seriousness was reported as non-serious. The outcome of the events was "Not recovered". Ethnicity information is available. Information on the lot/batch number has been requested.

caller doesn't feel great; Headache; was exhausted/she was so worn out, she just felt zapped; had chills; fever of 100; overall a feeling like she had the flu; had no appetite; felt sluggish; she slept most of the day; This is a spontaneous report from a contactable consumer. A 78-year-old female (pregnancy unknown) patient receive second dose in series of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN5318), via unknown route of administration on Right arm on 03Feb2021 09:00 (the day of vaccination), at single dose for covid-19 immunisation. The patient's medical history includes High blood pressure, and historical vaccine Caller had the First Dose on 13Jan2021 and it was Lot number EL3302. Caller had the Second Dose on 03Feb2021, and it was Lot number: EN5318. Caller reports that she got both doses via injection into the right arm. Concomitant medications were not reported. It was reported that caller states that she would like to talk about side effects from the COVID vaccine. Caller had the first dose of the product on 13Jan2021 and the second dose, this past Wednesday at 09 AM. Caller states that she was fine the whole rest of that day but then she woke up at 3 AM the next day and everything had changed. Caller states that she had a headache, she was exhausted, had chills, a fever of 100, it was overall a feeling like she had the flu. Caller is wondering if these are known side effects of the product because the caller's husband also got the vaccine, and he did not have any of these symptoms. Caller states that her primary care doctor is her Gynecologist and he is not aware that the caller even had the vaccine because she only goes to him once a year. Caller confirms the product was not prescribed to her by anyone in particular. Caller states that she had just read about the product and saw stuff on TV and thought that because of her age she should get it. Caller states that her brother in law is a physician and he told the caller to get the product. Caller states that her brother in law got the shot too and after his first shot he was fine but he had a few symptoms after the second shot, where he was feeling like he had the flu but he did not have as many symptoms as the caller had. Caller states that she got through the whole day of the day she had the injection and everything was great until 3 AM the next morning and she woke up with all the side effects. Caller states that she was so worn out, she just felt zapped, she had no appetite, a dull headache, she slept most of the day, fever of 100, and overall she felt sluggish. Now today, caller doesn't feel great, but she has no symptoms, she is just washed out. Caller states that she just guesses she did not know to expect that from the product. Caller states that she had heard there were some side effects and some people get them more than others but her husband did not get a single one. Caller is also wondering if the side effects will just go away on their own. Caller had no other vaccines on the same days as her doses of the COVID vaccines. Caller states that she has not had any bloodwork done in a while.

Pt developed palpitations, headache, dizziness and nausea after receiving vaccine. BP 192/81, repeat 206/86. HR decreased from 106 to 90; regular rhythm and rate. O2sat 99 RA. Lungs CTA. Denies chest pressure, tightness, sob. Also reported throat discomfort; benadryl 25 mg po x1 given. Sent to ER.

ADR began 6 days after the second dose. Caller states she spoke to PMD when she developed the diarrhea with blood beginning about 6 days after 2nd dose of vaccine. The MD recommended Urgent care , but urgent care recommended ED and patient went to the hospital. Went to ED Saw ED MD Diagnosed with diverticulitis and treated with IV fluids in ED and 10 day course of Flagyl that she began on 2/27 . CT scan incidental finding: Pneumonia Diverticulitis s/sx - mainly diarrhea with blood but perhaps slight Abd tenderness or cramps all of which abated while on Flagyl, but recurred after Flaygl stopped and then persisted until yesterday. She received trimethopril/sulfamethathoxazole for the pneumonia. which she took concurrently with the Flagyl Patient was not admitted to hospital. S/sx cleared completely 3/30. Patient had Diarrhea so bad she thought it was C.Diff, but tested negative for this - results just came in today. Note: Unable to obtain patient's date of birth. Patient is 78 years old.

Pt has allergic reaction w/ her 1st dose. She was in the middle of her graded COVID-19 Challenge (dose 2) under a physician's supervision. Pt just received 0.03ml (10% ) of full dose. Pt then started experiencing increased mucus in her throat, clearing of throat, and states that her ears feel weird about 11 minutes later. Her Vitals at this time were 168/78, 85 HR, 14Resp, 100% Spo2. 5 minutes later another set of vital signs were taken at 152/84, 86 HR, 16 resp, 95% Spo2. EPi 0.3 mg was administered immediately. Pt states that her throat feels better about 3 minutes later, but her chest still feels irritated. Her Spo2 was up to 100% at this time. Pt then stated that she is starting to feel shortness breath after using the bathroom. Pt is then transferred directly to the ER .

Two weeks and six days after the first shot, my left arm became swollen, as if it was lymphedema, something I don't get, or perhaps gout. After the second shot, the arm swelled more, with the hand looking like a balloon and a few days of tiredness. I put on a few pounds. Dr wanted to rule out a recurrence of breast cancer so she sent me for ultrasound, mammograms, and CT scans, with a week gap to take antibiotics for a UTI. At a coincidental checkup with my glaucoma doctor, he said the intraocular pressure had shot up and added 0.5% Timolol eyedrops, a beta blocker. In a few days, the swelling is less and the extra weight gone.

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.

rash; headache; No appetite; chills; sweat; fever; body aches; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: EM9809) via unspecified route of administration on 09Feb2021 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported that caller and his wife received the second dose of the Pfizer-BioNtech Covid-19 vaccine on Tuesday, he experienced a little of body aches that disappeared; however, his wife experienced a severe reaction: ongoing chills from 10feb2021, ongoing sweating from 10feb2021, ongoing headache from 10feb2021, from 10feb2021 to 11feb2021 experienced fever, ongoing body aches from 10feb2021 and today she broke out in rash on the front of her body from 11Feb2021 and ongoing no appetite from 10feb2021. They would like to know if there are any recommendations on what to do. Calling about the Covid 19 Vaccine. States that he and his wife had their 2nd doses of the vaccine on Tuesday afternoon. He had very little side effects; just body aches. But his wife woke up the first night after getting the shot with chills, fever, sweats, headache, and body aches. Today she is feeling a little better; her temperature this morning was 99.2, and she had a really bad headache. When she got in the shower, she noticed that she had a rash on her body; it doesn't itch. States that she has a little appetite today, which is good because she didn't eat at all yesterday. Asks, what does he need to do, if anything at all? States that he went on the Pfizer website and the side effects were listed there, one of the bad ones was a rash, so he would like to speak with Medical Information. Caller does not have the full contact information to provide for the prescribing physician. States that she got the shot about 2:15-2:30pm and the aide effects started about 12 hours later. States that she goes from being hot to cold to lukewarm, so the chills come and go. Her fever is gone, her temperature is now 97.5. The headache was really bad this morning, but she only feels a little pressure now. The rash is on her back and legs, but it has gotten better in the last hour. States that her appetite has improved; she just ate some breakfast. The lot number on the card is difficult to read due to the handwriting. Caller states that by comparing her card to his card, they think the Lot number is either EU9809 or EM9809. Caller later states that after looking at if for longer he really thinks it's EM9809. The outcome of the events for "Chills", and "Sweating" was "Not Recovered", for "Fever" was "Recovered", and for "Headache", "Body aches", "Rash", "No appetite" was "Recovering". Follow-up attempts are completed. No further information is expected.

Rash/The rash got worse from day to day as it spread throughout her body/The rash went from there to her face and went throughout body.; She also had swelling and itchiness with the rash.; She also had swelling and itchiness with the rash.; Low grade temperature 99.3 degrees; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Feb2021 15:00 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included hodgkin's disease from 2007, cardiac disorder was the patient taking concomitant products. Concomitant medication(s) included losartan (LOSARTAN) taken for cardiac disorder from an unspecified start date and ongoing; amlodipine (AMLODIPINE) taken for cardiac disorder from an unspecified start date and ongoing; warfarin (WARFARIN) taken for anticoagulant therapy from an unspecified start date and ongoing; Toprolol taken for cardiac disorder from an unspecified start date and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have history of all previous immunizations with the Pfizer vaccine considered as suspect. The patient did not administered any other vaccine on same date of the suspect. Caller on the line calling about the COVID 19 Vaccine. She was informed to call and report any reactions to the vaccine. She received the vaccine on 02Feb2021 and three days later she developed a rash. The rash started on her feet and spread throughout her whole body. She also had swelling and itchiness with the rash. Caller went to her primary care doctor on Monday 08Feb2021 and it was suggested to her to go see an allergist because the primary care doctor could not determine what this reaction could be other than the vaccine. The rash got worse from day to day as it spread throughout her body. It started on her feet went to her ankles. She then had swelling with it; it was itchy, very itchy. The rash went from there to her face and went throughout body. She noticed it in the afternoon on 05Feb2021. She had socks on and her socks were getting tighter due to swelling. She took her socks off and then noticed the rash. She also added, she had a low grade temperature. It was 99.3 degrees. Initially stated the low grade temperature started on Thursday 04Feb2021, but then stated it could have started Friday, she is not sure. It was one of those days. She thought she had a low grade temperature for two days. She did not even take the temperature the second day because she felt so crappy and did not feel like taking it. The caller was given a name of an allergist and she would go see the allergist on 18Feb2021. The patient did not visited to emergency room. The patient visited to physician's office. Outcome of the events rash, she also had swelling and itchiness with the rash were not recovered and unknown for other event.

Wheezing a little bit; Coughing all the time with Asthma; Tested positive for COVID-19; Tested positive for COVID-19; 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, lot number: not reported, expiration date: not reported via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 07:00 (at the age of 78-years-old) as single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing Asthma causes patient to have wheezing a little bit, which she has all the time and she also has coughing all the time with Asthma, ongoing diabetes mellitus (Onset date unknown other than more than 15 years ago and is ongoing). There were no concomitant medications reported. The patient experienced tested positive for covid-19 on 14Mar2021, wheezing a little bit and coughing all the time with asthma on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Mar2021 COVID-19 test. The outcome of event tested positive for covid-19 was not recovered and wheezing a little bit and coughing all the time with asthma was unknown. Follow-up activities have been completed and information on the lot/batch number has been requested.

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.

Pt @ 1745 began to feel dizzy, nauseous, and lightheaded, cold. Water and snack given BP 153/71, HR 62. @ 1802 symptoms resolved, pt able to return home.

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.

symptoms, signs, time course, etc.) 78 yo female patient with PMHx of paroxysmal atrial fib / COPD / smoking / anxiety-depression / obesity / arthritis and prior bil PE in 2018 after knee surgery (anticoagulated with Xarelto) who presented to FH on 03/30/2021 with SOB x2 weeks. Of note she received her 2nd COVID vaccine dose on 03/05/2021 and since she has worsening SOB. Pt reported cough w/ yellow sputum prior to her admission. At urgent care, she was hypoxic with Sat 82%, therefore she was transferred to ED for further w/u. Lab w/u showed BNP of 1,074 and trop of 32. She was found to have a negative POC COVID-19 and PCR is pending. Bil venous Dopplers show acute occlusive DVT in the R popliteal vein above and below the knee w/ slow flow in the R fem vein and no DV IN the LLE. TTE on 03/31/2021 showed EF 65-70% w/ G2DD, mod-severe RV failure and severe pulmonary HTN, mod TR, and dilated IVC. Decision was made to CT chest w/ contrast despite renal function given high suspicion for PE. CT chest w/ contrast showed large clot burden PE w/ findings c/w R heart strain, a 12x9 mm lobulated nodule in the RUL concerning for neoplasm, increasing patchy infiltrates, and increasing R pleural effusion and new trace L pleural effusion. Patient required 12L O2 via NC. IR was contacted at but felt that patient was not a candidate for CDT or for IVC filter. Patient was transferred to ICU for further care. Patient received IV heparin per the PE Protocol from, Alteplase 40mg on 4/1, and was started on treatment dose of Eliquis.

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.

Presented to ED with persistent cough X 1 week, some SOB. No obvious fever. ROS + for cough, shortness of breath and wheezing. BP 131/84 HR 107 RR 22. Admitted to general medicine floor on 2L O2 via NC, Rx with remdesivir + Dexamethasone.

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.

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,

Feeling a under the weather; This is a spontaneous report received from Pfizer sponsored Program. A contactable female consumer (patient herself) of 78-year-old received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in left arm at 12:20pm on 06Feb2021 at single dose for covid-19 immunization. Medical history include needs a hip replacement and concomitant medications were not reported. On an unspecified date, patient felt like feeling under the weather and thought pain reliver might help. The patient took Tylenol prior to having the vaccine. It was further reported that she has heard a lot having to do with the use of Tylenol. It was reported that she takes 3000-4000mg of Tylenol for pain a day because she was waiting for a hip replacement. she cannot deal with the pain if she takes less than 1000mg a day. She wanted to know any recommendations with the use of any pain medication, Tylenol or Advil with the effectiveness of the vaccine conjunction, as she had no problem with the vaccine. The outcome of the event was unknown. Follow up (09Feb2021): This is a follow up spontaneous report from a Contactable consumer. New information included relevant medical history, product details.

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.

Extremely sick with vertigo, nausea, headache, runny nose, mild fever. Sicker than I've ever been in my life. Couldn't even stand up.

Pt sated I just don't feel well and thinks she just got worked up with everything Happening. BP 166/77 HR 102. Said she didn't take meds today. . She signed refusal.

injection site pain; tiredness; joint pain; slight fever (<100F); chills; nausea; feeling unwell; This is a spontaneous report received from a contactable consumer or other non hcp reporting for herself. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in left arm on 28Jan2021 19:15 at a single dose for COVID-19 immunization. Medical history included hypertension and thyroidectomy. Concomitant medications included sertraline, pravastatin, cranberry and losartan potassium.T he patient experienced injection site pain, tiredness, joint pain, slight fever, chills, nausea and feeling unwell on 29Jan2021. The patient underwent lab tests and procedures which included body temperature as less than 100 Fahrenheit on 29Jan2021. The outcome of the event was not recovered. No follow-up attempts possible. No further information expected.

Extreme joint and muscle pain, extreme fatigue I took tyleno, tramadol and advil at the appropriate time periods, Very sore injection site; became very, very red swollen and went down my arm almost to my elbow, around to underside of my arm. The pain and fatigue lasted 1 week and I stayed in be most of the time as I felt terrible. The arm lasted approx 3 weeks, I used benadryl and over the counter cortisone cream.

aftereffects lingered for over 2 weeks and I am still somewhat compromised; headaches; weak legs- arms and shoulders more dominant on left side.; weak legs- arms and shoulders more dominant on left side.; This is a spontaneous report received from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 17Feb2021 14:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.Age at vaccination:78 years.Medical history included guillain-barre syndrome from Oct1986 and ongoing. The patient's concomitant medications were:None.The patient received first dose dose of the same vaccine 27Jan2021 at 01:45 P.M on left Arm via IM and developed headache and very weak legs on 27Jan2021 at 1:45 P.M. Vaccination Facility Type where the vaccine was administered was reported: Nursing Home/ Senior Living Facility. No other vaccines were received in the previous 4 weeks. The patient reported : Both shots resulted in days of headaches and very weak legs- arms and shoulders more dominant on left side. Second shot's aftereffects lingered for over 2 weeks and I am still somewhat compromised although, much, much improved. Onset date /time of the events was reported:17Feb 02:15. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 2020 (Between summer and winter of 2020). Outcome of the events was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021245697 Same reporter,patient/different dose

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.

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

Pt. describes headache starting immediately after vaccine. Describes as pressure 7/10. After evaluation by EMS, pt. has no change in condition. Pt. cleared by EMS to return home @ 10:25am. Pt. denies any other complaints. Driven by companion home. Will follow up with PCP prior to 2nd dose.

On 2/18/21, 10 days after receiving the vaccine, I donated blood as usual. About 30 minutes later I was light headed, had abdominal cramping pain, bowel emptying and possibly fainted. I was transported by EMTs to the ER and was later diagnosed with inflamitory bowel by a CT scan. I took antibiotics and was feeling fine. My gastroenterologist performed a colonoscopy on 3/24/21 and the findings were that I was healed and tissue samples were normal. 3/25/21 I had an annual physical and was told I was in good health. Later that afternoon I began feeling light headed upon standing. In the night I called my health insurance hotline because my blood oxygen meter was beeping continuously. The Dr. on call told me to go by ambulance to the ER. When sitting or lying down, I felt fine and all the tests at the ER for my heart and my vital signs were good. A few hours later, they did a hest Xray and then a CT scan of my lungs which showed a saddle embulism. I had also thought I had bruised my knee if and when I fainted on 2/18 and 1o hours later a blood lot was found by ultrasound of my left knee. I was given blood thinners in the ER and then in ICU where I spent the next night. I am now taking Eleris. I was also given pantoprozole for GERD coughing the next day. I continue to have periods of abdominal ramping/pain, light headedness in waves and pressure in my head. I have disontinued the stomach medication with some feeling better with the lightheadedness.

Pt developed HA, dizziness, and nausea about 10 minutes after vaccine. Denies chest pain, palpitations, SOB, but does endorse "indigestion"." Hx HTN, took all BP meds this AM. BP in clinic 203/84 and 186/81. Pt taken to ER.

severe pain; joint pain; headache; fever; nausea plus heavy chest feeling; Have persistent cough; Heavy chest feeling; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 13:15 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation. Medical history included gastrooesophageal reflux disease. Concomitant medication(s) included vitamin d3 (VITAMIN D3) taken for an unspecified indication, vitamin b complex (B COMPLEX [vitamin b complex]) taken for an unspecified indication, fish oil (fish oil) taken for an unspecified indication, biotin (BIOTIN) taken for an unspecified indication, start and stop date were not reported; famotidine (PEPCID [FAMOTIDINE]) taken for an unspecified indication. The patient previously took covid-19 vaccine for covid-19 immunisation. On 15feb2021, at 18:30 the patient experienced severe pain, joint pain, headache, fever, nausea plus heavy chest feeling and have persistent cough. The patient was recovering from the events. The action taken in response to the event(s) for bnt162b2 was not applicable. No follow-up attempts are possible. No further information is expected.

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.

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.

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.

Low grade fever, headache, fatigue, balance issues, some dizziness. Started 2/28/21. Continuing as of 4/26/21

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.

urgent continuous diarrhea, abdominal cramps, weight loss (5 lbs) in 3 days, dehydration, low blood pressure. clear liquid diet, blood pressure medications adjustment

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.

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.

Bronchitis; Sick; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 24Mar2021 (Lot Number: ER8730) as single dose for covid-19 immunisation. Medical history included bronchitis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced bronchitis, sick on an unspecified date. Therapeutic measures were taken as a result of bronchitis and sick. The outcome was unknown. No follow-up attempts are needed. No further information is expected.

Sore at injection sight (mild) next day. Nothing noticeable until 24 Apr 21 Pounding headache, fatigue, sleepy long periods , mild sore throat, blood pressure lower than usual . Temperature with in normal limits . I have been resting a lot , waiting for conditions to improve, however, as of this writing nothing has changed. Thus I decided to file this report. my I have not seen my healthcare provider yet but will make contact tomorrow

patient reports "feet feel dizzy and chest feels funny" and mild headache. Patient laid down, neuro exam wnl. At 11:48am, patient reports feeling relief.

Dull headache; Extreme Itching skin; This is a spontaneous report from a non-contactable other healthcare professional (HCP, patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 28Jan2021 11:45 AM, at single dose for COVID-19 immunization. Medical history included High blood pressure, known allergies to Sulfa drugs, shellfish. Patient is not pregnant. Concomitant medication included other medications in two weeks. No other vaccine in four weeks. Patient experienced dull headache for exactly 1 week. Extreme Itching skin from 1 week after and ongoing. Mostly in evening. event start date was 04Feb2021 07:00 PM. No covid prior vaccination. No covid tested post vaccination. No treatment received for the events. Patient was not recovered from the events. No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.

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.

Fever; Chills; Fatigue; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EE9231) single dose for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing, colitis ulcerative from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported; mesalazine (LIALDA) taken for colitis ulcerative, start and stop date were not reported; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported. The patient experienced fever (non-serious) on an unspecified date with outcome of unknown, chills (non-serious) on an unspecified date with outcome of unknown, fatigue (non-serious) on an unspecified date with outcome of unknown. No follow up attempts are possible. No further information is expected.

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

burning sensation in throat; mouth with a very metallic taste; mild taste distortion; fever; chills; aches; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EK9231) via an unspecified route of administration in left arm on 21Jan2021 at 17:00 as single dose for COVID-19 immunization. Medical history included CKD2, CAD, HBP, and Diastolic Congestive heart failure. The patient had allergies to medications, food, or other products Demerol, all statins was reported. Concomitant medications included Sertraline hydrochloride, valsartan, Ranexa, and Fenofibrate. 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. It was reported that App. 30 min. (21Jan2021 17:30) Post shot, had burning sensation in throat and mouth with a very metallic taste. Metallic taste lasted about day and a half. After that it cleared somewhat, but still have mild taste distortion. About day three did develop some fever, chills, and aches which lasted about three days. Treatment was not received for the adverse events. The events were considered as non-serious. The outcome of events was recovering.

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.

Per patient report / description: "The day after the shot I had a lot of arthritic type pain all over my body for two days then continuing pain until now 5/14/21. I cannot walk more than a block, cannot stand for more than 5-10 minutes, Lingering pain all the time." Called PCP with this report: " adverse reaction to my Pfizer 2nd shot. The next day after the shot it seemed like the vaccine searched out every part of my body that might/might not have arthritis and moving was very difficult for two days. Thereafter I have had a great difficulty getting up in the morning, some days better than others. I have seen (chiropractor) often, but results have not cleared up the discomfort. I cannot walk more than a block without discomfort, cannot sit unless my feet are up for great amounts of time then expect to be able to move. Is there something that you could prescribe that would give me comfort and be able to walk without pain. I am not interested in anything that would be considered an opioid, would rather go without. Currently I am taking Excedrin. Someone told me that Advil would be better for arthritis, but I had a bad headache on day two of taking that." Told to scheduled appointment with PCP for evaluation.

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.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were pneumonia, A-fib and hyponatremia. Patient died on 4/21/2021

About 45 minutes after 2nd shot I had very odd feeling of lightheaded and dizzy. Also felt like a tight band around chest and difficulty in a deep breath. This lasted about 20 minutes. Since then a lot of joint pain and fatigue

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.

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

feeling a click right before her fast heartbeat then drink water and slows it down/something clicks in body, heart beats really fast; really bad pain in her right knee; muscles really tight; didn't feel so good; she was scared to death, her nerves; anxiety; very frightened; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right on 21Jan2021 (at the age of 78-year-old) (Batch/Lot Number: EL1283) as 1st dose, single for covid-19 immunisation. Medical history included hypo thyroiditis (does not have it anymore, it was 30 years ago when she was a teacher), knee that was broken twice and allergic to antibiotics from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced feeling a click right before her fast heartbeat then drink water and slows it down/something clicks in body, heart beats really fast, really bad pain in her right knee, muscles really tight, didn't feel so good, she was scared to death, her nerves, anxiety and very frightened. The reporter stated that feeling a click right before her fast heartbeat then drink water and slows it down, was happened after she got her first covid shot. The patient asked to know if it was safe for her to get the second dose of the vaccine. The patient wondered if anyone else, she had the first Pfizer vaccine, later clarified as the COVID vaccine, a week ago last day before the time of this report, and she used to have a really fast heartbeat, but it slowed down, and once in a while, it was fast and stuff, now she had this happened twice, where she felt something click in her body, her heart beats really fast, and she drank water immediately, it slows down, has anyone said this after getting the vaccine. She has been on the phone for two hours. She never had a little click, she had thyroid hypo thyroiditis and every evening she would have a fast heartbeat, her blood pressure would go, but she never had when she would feel this little click, like a little, and her heart was really fast in morning of the report, it was really fast, and the minute she drinks water, it slows it down, it does not make sense. Also, her muscles are really tight, she was 78 and having a hard time with this pandemic, her nerves not good, she was nervous about the vaccine. She stated she was a teacher, and her weight was 106-107 pounds. About the event feeling a click right before her fast heartbeat then drink water and slows it down/something clicks in body, heart beats really fast, the patient stated, unknown when this started, exact date unknown, this has happened twice, this morning was the second one, and the minute she drank water, it slows it down, but it was very very fast, and she did not feel so good after, she was scared to death, her nerves are shot, she has trouble with anxiety, she was feeling ok now. She was nervous about what was going on and would feel better if someone else said they experienced the same. About the event muscles being really tight, the patient stated she has knots, her muscles are tight in her shoulders and neck lots, last night she was writing recipes, she does recipes boxes for her grandkids, and she was using her right arm a lot, she does not get to go to spa since the pandemic, she has not gotten to go to her for over a year. Her husband rubbed it out, and she did heat. Her muscles were tight right after she did it, so it could be something, it said if you think you had a symptom and also the second night after, she had a really bad pain in her right knee, it lasted one night, it was a knee that was broken twice, which may be why it was that leg. She was very very frightened to take it, she reacts to things strangely, when she has any procedure, they always say they never had that happen to anyone, she was allergic to antibiotics, different things happen when she takes different things, she was nervous about the whole thing, which may have to do with it. The second dose is on 12Feb2021. The outcome of the event muscles really tight was recovering and unknown for other events. Follow-up attempts are completed. No further information is expected.

Patient has a blood clot; Pain sent patient to the emergency room; Patient was tired, and was having a hard time breathing. Patient was thinking it was something else; Patient was tired, and was having a hard time breathing. Patient was thinking it was something else; This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported for a 79-year-old female patient (reporter's mother) that: Submitted by Call Centre Selected Report Type: Initial Is report related to a study or programme? No Patient Ethnicity: Unknown Is the patient also the reporter? No Reporter type: Consumer or other non-health professional Specify Consumer or other non-health professional: Reporter is patient's daughter Primary / Prescribing Healthcare Professional Info Adverse events: Dates for Patient has a blood clot: (From: Apr2021 To: Ongoing) Reporter seriousness for Patient has a blood clot: Hospitalization Dates when patient was in hospital for Patient has a blood clot: 29Apr2021 to 02May2021 Dates for Pain sent patient to the emergency room: (From: 26Apr2021 To: Ongoing) Reporter seriousness for Pain sent patient to the emergency room: Unspecified Dates for Patient was tired and was having a hard time breathing. Patient was thinking it was something else: (From: Apr2021 To: Ongoing) Reporter seriousness for Patient was tired and was having a hard time breathing. Patient was thinking it was something else: Unspecified Is Pfizer covid vaccine a Pfizer product? Yes Pfizer covid vaccine manufacturer: Unspecified Dates for Pfizer covid vaccine: (Start: 20Feb2021 Stop: Unspecified) NDC number of Pfizer covid vaccine: Unknown Expiry Date of Pfizer covid vaccine: Unknown Why was the patient taking Pfizer covid vaccine (Verbatim): Because of patient's age Other Products: No Patient History: No Investigation Assessment: No Additional Context: Reporter is calling on behalf of someone else. Reporter is calling about the Pfizer covid vaccine. Reporter is hoping for some guidance. It is reporters understanding, that if there is complications after the covid vaccine, there is compensation available. She is asking does she need to go somewhere for that. Reporter is calling about her mother. Reporter's mother is the patient. Reporter's address: Reporter was asked for her mailing address. Reporter stated that she will provide patient's mailing address, that it would be easier to provide patient's address. Primary / Prescribing Healthcare Professional Info: Declined. Patient has a blood clot: Patient is now out of the hospital, but she is on a blood thinner for the next six months. She was diagnosed with a blood clot and hospitalized on 29Apr2021. Patient began having adverse reactions two weeks prior, but patient did not realize they were related to her blood clot. Reporter does not know an exact start date. Patient is getting better with the blood thinner, but the blood clot is still there. Pain sent patient to the emergency room: Pain began on 26Apr2021. Patient is still in pain, but it is not as severe. Patient was tired and was having a hard time breathing. Patient was thinking it was something else: Began about two weeks prior to being diagnosed with a blood clot. The problem is, it is a large blood clots, and has done damage to patient's lungs. Reporter states because of the blood thinners that patient is having to take, patient is having complications. The blood thinners are very expensive. The blood thinners are interfering with other medications that patient is on. No further information provided. First dose administered on 20Feb2021 about 12:00PM in left arm. Lot number: EL9266 NDC: Unknown Expiry date: Unknown Second dose administered on 13Mar2021 at 1:30PM in left arm. Lot number: Unknown NDC: Unknown Expiry date: Unknown Patient Age at Time of Vaccination in Years: 79 Vaccination Facility Type: Other, Pop up clinic. Vaccine Administered at Military Facility? Not provided. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Did any AE(s) require a visit to: Emergency Room? Yes. If the patient was hospitalized, how many days was the hospital stay? Four days. Physician Office? Yes. Patient has saw an oncologist, primary care physician, neurologist and pneumologist. Prior Vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: Not provided. Patient's Medical History: None. Family Medical History Relevant to AE(s): None. Relevant Tests: None. Reporter is asking what all she needs to submit to Pfizer Legal. Reporter is asking if she needs a lawyer to handle this. PSCC Communication: Caller notified that all requests for compensation will need to be made in writing to Pfizer Legal. Caller was provided with Pfizer Legal Department's address of Pfizer, Inc. Legal Department Follow-up attempts are needed. Additional information is requested

diarrhea; Tired; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A 78-Year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EM9809), via an unspecified route of administration on 25Feb2021 in left arm as 1st dose, single for COVID-19 immunization. Medical history included allergic to soy and dairy products, allergic to naproxen, diabetes, high blood pressure, supplementation therapy. Patient previously took and statins and developed joint pain. Concomitant medications included metformin 500mg 2 tablets in the morning and 1 tablet at night for diabetes, lisinopril 20mg twice a day by mouth for high blood pressure, vitamin d3 at 50mcg once a day by mouth as supplementation therapy. It was reported that metformin, ER > She said that she thinks she is over medicated. No further details provided. Vitamin D3, extra strength. stated that they put white writing on a white label. 31Jan2022, Lot 20123519, natures way. Patient was calling about the Covid-19 vaccine. She said that she had a reaction she believes. She said that she had the shot between 10-1030 today (25Feb2021) and left the facility and was home by about 1130 and all of a sudden she had a overwhelming diarrhea attack with no warning or anything. She did not eat anything to cause it. She said that she is afraid to take the next shot. She said that she had allergies to Statins and Naproxen and they make her throw up. Patient clarified that Statins gave her joint pain, but she does not remember what the drug names are. There was another drug that she got muscle cramps and joint pain, but she was unable to provide that information. She can not take Zetia and had a reaction. She said that she always throws up from pain killers. Patient had no NDC, lot, or expiration date for any of the above mentioned medications. It was samples that the doctors gave her. She said that some of them made her joints locked up and the others caused muscles cramps. No further details provided. She said that she was tired and did not sleep last night. Patient said that she shrunk. Patient said that it was just one episode of diarrhea at this time. She said that she was also very tired. She was tired for about a hour and it went away,. She is still a little tired, not the overwhelming tiredness she had earlier. She said that she was doing a puzzle and could not even focus on it. She had to lay her head down on the table to rest. She said that there was a little bit of pain when they stuck the needle in her arm, but no pain since. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

it recurred as a severe headache; mild headache/lingering mild headache; This is a spontaneous report from a sponsored program support via a contactable consumer (patient) reported for herself. A 78-year-old female patient received second dose of BNT162B2 (COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 13Feb2021 (age at vaccination was 78 years) as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included prednisone acetate. The patient previously took first dose of BNT162B2 (COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown; Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE for COVID-19 immunization. The caller declined transfer as she had already given all of her information. She was open to being followed-up with by the safety department and indicated that email was the fastest way. The caller was a consumer who completed her COVID-19 vaccine series on 13Feb2021. On 16Feb2021 and 17Feb2021, she woke up with a mild headache, which resolved. On 19Feb2021, it recurred as a severe headache, and caller stated she was worried she had a brain tumor. She went for an MRI, which came back normal. Her headaches persisted, and her provider prescribed Prednisone 20mg for 5 days, which she thought cured her headache. The headaches had persisted, but she reported they were "minor" and "annoying". Typically her headaches were present in the morning and resolved throughout the day. Her headache, today, persisted which prompted the call to report. She asked whether they had reports of this happening to anyone else. She received a response stating that headaches are commonly reported AEs, which are more common after the second dose. Provided usual duration from attached "CONS -How long side effects last final (v2.0)". Directed caller back to HCP for treatment advice, if she were to experience additional symptoms, or if she forgot anything in her report. The caller called because she took the vaccine in February and has had a lingering mild headache since then. She wanted to know if it was because of the vaccine because she never had headaches. The outcome of event mild headache/lingering mild headache (first occurrence) was recovered on an unknown date in 2021. The outcome of the event it recurred as a severe headache (second occurrence) was unknown. Follow-up #01 (14May2021): New information received from support via a contactable consumer (patient) included: Details regarding reporter's contact information availability and medical questions addressed by the program forwarded/referred to Medical Information. Follow-up #02 (14May2021): New information received from support via a contactable consumer (patient) included: No new information and adverse event added. Follow up attempts are completed. No further information is expected.

headache; hard to sleep; This is a spontaneous report from a contactable consumer (patient herself). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration in left arm on 26Jan2021 (at the age of 78-years-old) as single dose for covid-19 immunisation. On an unspecified date, the patient started receiving lisinopril (LISINOPRIL) Dosage text: 20mg, 1 tablet, oral for blood pressure measurement, cardiac disorder and was Ongoing. No lot number was provided for Lisinopril due to Product dispensed in pharmacy vial. The patient was taken Covid vaccine due to her age and heart issues. Relevant medical history and concurrent conditions included pacemaker inserted on Oct2011 and ongoing, had it replaced Jan2020. No further details provided. Pertinent Details include surgical procedures and dates were Pacemaker inserted Oct2011 and Jan2020. No other AE following prior vaccinations. No family Medical history relevant to AEs. Relevant Tests were none. History of all previous immunization with the Pfizer vaccine considered as suspect was None. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No other Prior Vaccinations were taken within 4 weeks prior to the first administration date of the suspect vaccine. No Other Products were reported. No Investigation Assessment. On an unspecified date in Jan2021, the patient experienced headache and felt hard to sleep. It was reported that patient getting a bit of a headache almost every day for almost 2 weeks. Patient reported about 2 weeks ago she got the first dose of the Pfizer Covid vaccine. She wants to know if this was expected and if it will be worse on the second dose. She had a question about the side effects. It's not serious, but she just had like a headache every day and wondered how long side effects supposing to last. Patient got the vaccine on Tuesday, 26Jan2021 and the headaches started like the next day. It was still there sometimes worse than others and at night it had bothered her more. She doesn't have them nightly and it's hard to sleep. No further details provided. Patient Mentioned she did see the cardiologist and her medication Lisinopril was increased to 20mg once daily. Does not know if that had anything to do with the headaches. Patient clarified the headaches were before she had the medication increase. Not visited Emergency Room due to events. Event headache caused Physician Office to visit. Outcome of the events was not recovered. Follow-up (08Feb2021): This is a follow-up Spontaneous report from a contactable consumer. New information included patient details, RMH, Outcome of the events. Description of Product Complaint: Did see the cardiologist and her medication, Lisinopril was increased to 20mg once daily. Clarifies the headaches were before she had the medication increase. Unable to provide NDC, Lot or expiry from pharmacy bottles. Product strength and count size dispensed: 20mg Follow-up attempts are completed. No further information is expected.

headache; feels lightheaded and as if her head is floating around; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 2 via an unspecified route of administration on 26Feb2021 2nd dose, single for COVID-19 immunization. The patient took historical BNT162B2 on 05Feb2021. The patient medical history was not reported. The patient's concomitant medications were not reported. On 27Feb2021, the patient experienced woke up this morning with a headache, feels lightheaded and as if her head is floating around. Therapeutic measure was taken with Tylenol and her headache went away. She now feels lightheaded and as if her head is floating around and she was not dizzy and her balance was not off. The patient would like to know if her lightheadedness was associated with the vaccine. The clinical outcome of the events headache was recovered and event feels lightheaded and as if her head is floating around was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

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.

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.

Shortness of breath, extremely tired, chills. nausea, feeling unwell, lymph nodes, allergic reaction such as rash, extreme itching, swelling of face, loss of taste and smell, severe congestion upon awakening. PCP is out of town entire month of June. Sick of being sick. Must be remedy to all of this! Am not recommending to my friends. I should have never had second vaccination.

Tooth reinfected between the two doses; Fever and chills; Fever and chills; This is a spontaneous report received from a contactable consumer (Patient). A 79-year-old female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: ER2613), via an unspecified route of administration on 18Mar2021 (at the age of 78-year-old), as single for Covid-19 immunization. Medical history included thyroid cancer from 1979 to an unknown date, osteoporosis, back surgery, car accident prior to the pandemic, broken wrist and nerve damage, head and neck cancer, stroke, Brain tumor (inactive), vestibular issues, corneal transplants (two), tooth infection/ like slow infection from 2018 to an unknown date; she was visually disabled; her root canal that got infected and her thyroid was removed surgically, both from 2018 to an unknown date. The previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation solution for injection; Lot number: EN6202), via an unspecified route of administration in Arm left on 25Feb2021 (at the age of 78-year-old), as single for Covid-19 immunization and Shingrex vaccine with horrible reaction. The patient's concomitant medication included levothyroxine (LEVOTHYROXINE) taken for thyroid hormone replacement therapy and zoledronic acid (RECLAST) infusion one time in a year, taken for osteoporosis. On an unspecified date, after the second dose the patient experienced tooth reinfected between the two doses, fever, and chills. She stated that she went to a site where vaccines were being administered by nurses and mentioned that she was diagnosed with cancer there in 1979. When she got the first dose of the vaccine, she had to fill out a health history form, had to talk to a nurse about it, then she got a shot while at the second time around it was different because the nurses leaned in the back window to talk to her and gave her the shot, and she did not have to fill out a form during second shot. The nurses told her that her vaccine would only be 40% effective because of her cancer history as her PSH scores showed that she had a weakened immune system. she was a thyroid cancer patient survivor as her thyroid was removed surgically and was on hormone replacements for that, prior to the vaccines. They also tested her TSH scores. She has not had chemo but a month before the pandemic the doctor started doing labs to track her PSH levels and was going to change her thyroid hormone doses. She took a thyroid hormone replacement, levothyroxine. She stated sometimes if the dose was wrong, got heart palpitations. She stated she used to be on 112 mcg and now was on 75 mcg. She was hoping that doctor knew about endocrinology and had figured out why her hormone replacement was not as effective as it should be. They checked her labs but had not called and said that she had a better immune system. They kept pushing her procedures further and further without diagnosing her. They tested her for covid antibodies, but she tested negative. She had stoke, brain tumour that was inactive, vestibular issues, two corneal transplants, and she was blind. Additionally, she had a horrible reaction to the Shingrex vaccine in the past and mentioned that she got vaccines for everything as she was trying to live to be 90 years old. she was also on Reclast infusion one time a year for osteoporosis and wanted to know if that could affect the vaccine, she was recovering from back surgery, was in a car accident prior to the pandemic, she typically would get shots in her weaker arm as she had a broken wrist and nerve damage, prior to the vaccines; she was visually disabled, since before vaccines; she was a head and neck cancer, and stroke, prior to vaccines. She had a root canal that got infected in 2018 and it was like a slow infection, started prior to the vaccine which was reinfected between the two doses, had fever and chills. She thought it was a reaction to the second dose then realized it was the infection in her mouth. Hence, she saw her dentist. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

She got her vaccine, had no reaction. The next morning/afternoon she had a headache/head pressure, light headedness. As the days went on she had impaired equilibrium issues, which she is still having therapy for. She called her doctor after about 4 weeks of experiencing these symptoms every day, and he suspected that since she was dizzy and had equilibrium issues that it could be an inner ear problem, and referred her to an ENT. She went to the ER with pressure in her chest and headache. She had an EKG, stress test, doppler on the carotid arteries, and chest x-ray. All of these tests were negative for any findings. She then saw the ENT and he ruled out Meniere's disease, any inner ear problem, ordered a brain MRI. This showed mild constriction of the small blood vessels consistent with her age and that was all. She continued to have the problems, and her PCP recommended balance therapy and sent her to therapy for that. This therapy is helping her, and she continues to still go for the therapy. Any of the doctors that she saw felt that it was an over-reaction of her immune system to the vaccine.

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.

tested positive for COVID-19/tested positive for covid 19 virus after receiving covid 19 vaccine; flu like symptoms; achy body; high temperature; there was throat involvement; very, very ill/sick; This is a spontaneous report via Pfizer-sponsored program and medical information team from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266) via an unspecified route of administration, administered in left arm on 25Feb2021 as 1st dose, single for COVID-19 immunization. Medical history included thyroid disorder, ongoing incontinence. Concomitant medications included mirabegron (MYRBETRIQ) for Incontinence. Patient previously years ago took flu vaccine and she had feel sick with flu, she did have flu symptoms. No Prior Vaccinations (within 4 weeks). On Sunday (28Feb2021), she became very, very ill with flu like symptoms, she had an achy body, she had high temperature, there was throat involvement. She had those symptoms until Monday (01Mar2021) and was feeling better on Tuesday (02Mar2021). On Wednesday (03Mar2021), she had a COVID-19 test and it tested positive for COVID-19/ tested positive for covid 19 virus. She thought she was having a reaction to the shot when she got sick. Yesterday was her last day of self-isolation. She has not had another test, she was senior. She was scheduled for her second dose of the vaccine a week from now from tomorrow (19Mar2021) and she wanted to know if she should have the second shot or she has to undergo an antibody test since she got COVID after the first dose. The outcome of tested positive for COVID-19/tested positive for covid 19 virus after receiving covid 19 vaccine was unknown; for illness recovered on 28Feb2021, flu like symptoms recovered on 02Mar2021, while for others was recovering. No follow-up attempts are possible. No further information is expected.

syncope; Acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; hemorrhagic contusion with edema; hemorrhagic contusion with edema; fatigue; malaise; HA; This is a spontaneous report from a contactable physician. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 21Feb2021 (Lot Number: EN6200) (at the age of 78-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension (HTN), hyperlipidemia (HDL) and hypothyroidism, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The patient previously took SSRI, PNC (unknown), sulfa and oxycodone; the patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 31Jan2021 (Batch/Lot Number: EL9265) as single dose for COVID-19 immunisation. Within 12 hours of vaccine (on 22Feb2021) the patient developed symptoms of fatigue, malaise, headache (HA) and severe and near syncope. She visited the emergency department (ED) the following day. Work up at that time including blood work and no imaging. She was treated with IVFs and discharged. Symptoms of malaise, fatigue and HA persisted for > 1 week. A computerized tomogram (CT) of the head was performed on 05Mar2021, this CT showed the following: acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; 2X3 left front hemorrhagic contusion with edema. The events required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the events and includes conservative measures (as reported). The patient outcome of the event was recovered with sequel.; 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 reported events 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.

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.

After the first vaccine patient was down for 4 days with achey body, tiredness, fever, chills; After the first vaccine patient was down for 4 days with achey body, tiredness, fever, chills; After the first vaccine patient was down for 4 days with achey body, tiredness, fever, chills; After the first vaccine patient was down for 4 days with achey body, tiredness, fever, chills; 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: EL9261), dose 1 via an unspecified route of administration, administered in Arm Right on 01Feb2021 12:00 (at the age of 78-year-old) as 1st dose, single for COVID-19 immunisation. Medical history was none and no known allergies. There were no concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID. The patient did not receive any other vaccines within four weeks. Post vaccination, the patient had not been tested for COVID. After the first vaccination in Feb2021, the patient was down for 4 days with achy body, tiredness, fever and chills. The outcome of the events was unknown. Follow-up attempts possible. No further information expected.

Fatigue/I am still tired; My chin is like its frozen like I had been to the dentist and my right side of my lip is frozen; My chin is like its frozen like I had been to the dentist and my right side of my lip is frozen; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6198) via an unspecified route of administration on 04Mar2021 as 2nd dose, single dose (at the age of 78-years-old) for COVID-19 immunization. Patient medical history included high blood pressure, mastocytosis and stage III kidney disease. To stabilize the high blood pressure she takes a bunch of other stuffs too. The concomitant medications included montelukast, aspirin [acetylsalicylic acid], fexofenadine hydrochloride (ALLEGRA). Patient reported that she takes Allegra with two Aspirin because that activates the Allegra. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9269 (as reported)) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. About the lot number of first dose patient stated, she believes its FL, its EL9269. On an unspecified date in Mar2021, patient experienced fatigue, she was still tired, her chin was like its frozen like she had been to the dentist and her right side of her lip was frozen. Patient stated she had the usual symptoms, she had the second shot on 04Mar2021 and she was fatigue the 2nd day she guesses that was normal and the following day, she was still tired today. The other thing that she did not see that the usual thing was her chin was like its frozen like she had been to the dentist and my right side of my lip is frozen like she had been to dentist. She meant is that something that happens sometimes to different part of your body where the virus settle or the vaccination settles or maybe it will go away or (statement incomplete) she was wondering if you ever heard that before she meant you hear lots of things but (statement incomplete). Patient stated, in general are there drugs that cause a problem when you take them before you take the vaccine or may be there is not. She meant she takes a lot of things but and she took Aspirin she guessed she should not have taken that before she took it but. Patient did not receive any treatments for the adverse events. Lab work information included patient stated she had done just a routine physical on 05Feb2021 and she did have blood work done then. Patient further stated she had her chart for data care as her chart it might say on this. They checked her kidneys as sometimes she was considered stage III kidney disease, they check that, she did not know. The outcome of the event fatigue was not resolved while of other events was unknown. No follow-up attempts are possible. No further information is expected.

Arm was very heated. Became red at the site, then spread from elbow to above site and covered 2/3 of upper arm.; Arm was very heated. Became red at the site, then spread from elbow to above site and covered 2/3 of upper arm.; Have a knot about size of ping pong ball; Had flu like symptoms; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 24May2021 15:45 (Batch/Lot Number: EWOI86) as single dose for COVID-19 immunisation. Medical history included High blood pressure, high cholesterol, arthritis, nerve damage. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication(s) included benazepril (BENAZEPRIL) at 5mg; rosuvastatin (ROSUVASTATIN) at 5mg; mometasone furoate (NASONEX); gabap (as reported), all taken for an unspecified indication, start and stop date were not reported. The patient previously took vioxx, atorvastatin (LIPITOR) and chlorhexidine diacetate and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that on 25May2021, 16.00, arm was very heated. Became red at the site, then spread from elbow to above site and covered 2/3 of upper arm. Have a knot about size of ping pong ball. Had flu like symptoms. The patient used Cold compresses, Tylenol to treat the events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering.

very serious extreme anxiety; nausea, severe nausea, where she couldn't eat; Severe Headache; Abdominal pain; Dry heaves; she had a morbid feeling; feeling of doom; lost 13 pounds; hypothyroid went to hyperthyroid; Aversion to Food; Anorexia; nausea, severe nausea, where she couldn't eat; This is a spontaneous report from a contactable Nurse (patient). A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 11Jan2021 10:50 (Batch/Lot Number: EJ1686; Expiration Date: 20Mar2021) as 2ND DOSE, SINGLE, vaccinated at the age of 78 years old for covid-19 immunisation. Patient received the first dose on 21Dec2020. Medical history included ongoing hypothyroidism Diagnosed 20 years ago, ongoing colitis, ongoing proctitis, ongoing diverticulum, ongoing gastrointestinal pain, and breast cancer. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported. Caller states she was told by a couple of doctors that she needed to report this. Caller states her first vaccine was 21Dec2021 and then her second dose was on 11Jan2021. Caller states four days after the second dose, she wound up in the ER with severe headache, abdominal pain, dry heaves and she had a morbid feeling. Caller states after that, she saw her doctor and for two months she had problems with nausea, severe nausea, where she couldn't eat, lost 13 pounds, hypothyroid went to hyperthyroid, very serious extreme anxiety, which she is still battling. Caller states the Endocrinologist felt it could've been associated with the vaccine. Caller states the ER ran tests and abdominal scans and all they showed were the usual things she knew she had, nothing new. Caller states she asked the ER doctors, and they said they didn't know if it was related and when she asked Endocrinology, they said they don't know for sure. Caller states her Primary doctor said it could be related, anytime a person has a vaccination, if they are immunocompromised or have inflammation, it can possibly trigger this and events occur. Caller states she had dry heaves, an aversion to food, lost weight, and had terrible anxiety, all four days after vaccine. Caller states after the first vaccine, she was fine. Caller states after the second vaccine, she woke up that morning four days after, it was acute, this had never happened before and she had a feeling of doom and dry heaving. Caller states it took her two months, before she started to eat and put the weight back on. Caller states the nausea is gone and she is able to eat and put weight back on. Caller states she still has extreme anxiety and she is seeing a doctor for that and is being medicated so it is persisting by improved with medicaiton. Caller repeats, this all happened four days after her second injection. Caller states no one knows that much about the vaccine but they said something that this reaction should be reported. Caller states the nausea and other GI issues lasted for about two months, but she can't give actual dates of when it recovered. Caller states she doesn't know dates of when the other side effects recovered, but they only thing she still has is the anxiety. Seriousness: Caller states the Nausea was disabling, she couldn't eat at all, she had to drink ensure and boost. Caller states the rest were medically significant. She was worked on by her PCP and Endocrinologist, and they adjusted her thyroid medication to bring back down her levels, and she is sure that is part of the reason for her anxiety and anorexia. Caller states before she had hypothyroid. Treatment: Suppositories, Zofran, Reglan, Anxiety Medication, Adjustment of the thyroid medication Synthroid. States when she lost an extreme amount of weight, her thyroxin increased, so they dropped her dose to the normal range. Causality: Caller states she feels it is related because it was an acute onset and rare for her, even though she is older, she is healthy. Caller states she has had breast cancer but nothing that stopped her from working. Caller states it is hard to know, but she thinks it is related. Caller states her one son was home and called and said mom looks like she is going to pass out and she is not an alarmist and usually would say no, but she said yes, he better make sure that she gets to the ER, she felt impending doom, with abrupt onset. Tests: Caller states they did an Endoscopy and Colonoscopy because of her abdominal pain and they found colitis and proctitis and every, itis, a person can think of along with diverticulosis and inflamed gut, but she already had those, they were not caused by the vaccine, she had them in the past. Outcome of anxiety was recovering, of others was recovered in Jan2021.; Sender's Comments: Based on the temporal relationship between events anxiety, nausea, headache, abdominal pain, retching, malaise, weight decreased, hyperthyroidism, decreased appetite, eating disorder and company suspect BNT162B2, the causal relationship cannot be denied. 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.

Feeling unwell; fast heart beat; nauseous; unbalanced when walking; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9810 and Expiration date not reported) via an unspecified route of administration, administered in Arm Left on 04Feb2021 14:35 as 1st dose single dose for COVID-19 immunisation. The patient medical history included anxiety from Unspecified to Unspecified date. The patient concomitant medication included alprazolam (XANAX) taken for anxiety from Unspecified to Unspecified date. The patient received no other vaccines in the past 4 weeks period. On 05Feb2021, morning, she noticed she is feeling unwell and had a fast heart beat. After eating it got a little better. It says on the paperwork normal side effects to expect like feeling unwell and fast heartbeat which has calm down for her, but she was wondering how long this was expected to last and have the side effect. She was not feeling good this morning. She doesn't want this to last a long time. The patient reported that after the vaccine she felt nothing, no pain, no pain even at the arm. The patient reported that, she was not completely sure how she was feeling because she was sitting now, she felt nauseous and unbalanced, she was feeling unwell. As she was sitting down, she thinks it was better, but she still feels unbalanced when walking. The patient took half a Xanax when her heartbeat was fast, that was usually the trick that slows it. It was reported that, she takes Xanax for anxiety and maybe that was it was. She took the Xanax because she had to wait on the phone for so long to speak to someone. The second dose was schedule date on 02Mar2021. The patient had so many medications, but had not taken them before this started, she took them later. The patient received list of what she could expect, on the list what she had was a common reaction, but the Fast heart rate was in the call section, but it was not that bad for her to call 911 as she knows a fast heartbeat can happen with her anxiety. She usually gets the flu vaccine and pneumonia vaccine, she does not remember when she had it last, she usually gets them when it comes out or when pharmacy announces it and asks her. The patient noticed that people who usually get the COVID virus die of Pneumonia, so she thought she would get the pneumonia vaccine. The patient had some exam 2 weeks ago, and yesterday the Physician left a message about the results and did state on the phone that she has nothing to worry about. The outcome of Feeling unwell was not resolved and fast heart beat was resolving. Follow-up attempts are completed. No further information is expected.

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.

Had spinal surgery 5/16 and was at an inpatient rehab facility until 6/3 where discharged and then readmitted back to Hospital on 6/4 due to spinal complications. She was then discharged on 6/9/2021 to home. Thus case was readmitted due to spinal surgery complications, not due to to COVID.

12 hours after vaccine patient developed bilateral lower extremity "paralysis". She felt feverish and achy at night, didn't sleep well, and at 6am decided to get up and couldn't move her legs. She remembers using her hands to move her legs over. She tried to stand but slid down off the bed. It took about an hour until she could put weight on them. Felt normal by the next day. Exam and labs 1 week later normal. Back to baseline active self. Denies LOC, no upper extremity sx, no edema. Didn't try to wiggle her toes. Was advised not to get the booster dose.

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.

It was kind of like she was having some coughing; she was not feeling real good before she went to receive her second dose/stuff; This is a spontaneous report from a contactable consumer. This is case report for first dose. This 79-year-old female consumer reported for herself that who received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number and expiry date was unknown) via an unspecified route of administration on 11-APR-2021 (at the age of 79-years-old) as a single dose for COVID-19 immunization. Medical history included asthma and allergies that are chronic. Concomitant medication was not reported. The patient stated that on an unknown date her breathing was at 113 percentage breathing capacity (good) and the allergy specialist wanted her to go ahead and get the injection, which the patient did. The patient clarified that she received the first dose of vaccine and that she did really good with that one. The patient explained she was not feeling really 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. The patient then received the second COVID vaccine on 13May2021. She came home and slept almost all night long and thought she was okay. Outcome of the events was she was not feeling real good before she went to receive her second dose/stuff and coughing was unknown. Information on the Batch/Lot number has been requested.

Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; BP was high; high heart rate & MAP; high heart rate & MAP; tired; left side of throat felt swollen; feelings of being "out of sorts"; Small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins; Mild nausea; Arm soreness at vaccination site; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in left arm on 14Mar2021 13:15 (at the age of 78 years old) as 2nd dose, 0.3 mL single for covid-19 immunization. Medical history included thyroid nodules, mild macular degeneration, postmenopausal syndrome, high blood pressure (HBP), total hysterectomy w/oophorectomy, gallbladder removal, appendectomy, allergy to penicillin, allergy to contrast dye, allergy to adhesives, and hard of hearing (HOH). Concomitant medications included valsartan (DIOVAN); famotidine (FAMO); pravastatin; estrogens conjugated (PREMARIN); levothyroxine sodium (SYNTHROID); and vitamin D3, all taken for an unspecified indication, start and stop date were not reported. The patient previously took nitrofurantoin (MACRODANTIN), clarithromycin (CLARITIN) and experienced drug drug allergy from both; also previously received the first dose of BNT162B2 (Lot number: EN6201), on 14Feb2021, 13:00, administered in left arm, for COVID-19 immunization. On 14Mar2021 late same day, the patient experienced mild nausea which lasted less than an hour, arm soreness vaccination site. On evening of 15Mar2021, a small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins. Upon waking on 16Mar2021 the patient was still itching spots plus left eye was itchy, dry and red; with a bit of nausea, BP was high, no fever, high heart rate and mean arterial pressure (MAP), was tired, left side of throat felt swollen, feelings of being "out of sorts", and her arm no longer hurts at all. The patient took Benadryl and Aleve and all seem better at the moment. She stated she would describe her symptoms as mild although somewhat scary especially the increase in blood pressure and MAP. Her oxygen was normal at 95-97. The patient was recovering from the events.

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.

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.

--2 reactions to report: --After the first dose of Pfizer shot, patient experienced shortness of breath immediately after with tight, constricted throat. An hour later reports having severe chills and fatigue which lasted the next 24-36 hours. This then subsided. --After the second dose, patient reports the same respiratory reaction, but this time also had severe pain in the arm at the injection site, along with heat and redness and itch down the arm. 24 hours later patient reports significant swelling in the right breast (patient was being treated for breast cancer with radiation) went to see dermatologist and other doctor to have it examined. They determined that the breast tissue that had radiation is where the reaction occurred. Doctor described seeing several patients on radiation who had the Pfizer shot report the same side effect. Patient reports the inflammation in the breast took several weeks to fade away, estimates 4 weeks. And now still experiences heat and itch in the arm 2.5 months later to this day.

day after getting the 1st dose she got a headache/chills/low temp/couldn't more left arm/arm, neck and shoulder pain

feels dragged out and a little shaky; feels dragged out and a little shaky; This is a spontaneous report from a contactable Consumer or other non-health professional (patient). A 78-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via intramuscular route of administration, administered in right arm on 02Feb2021 at 14:30 hours as 1st dose, single dose (at the age of 78-years-old) and on 23Feb2021 at 14:30 hours as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Feb2021, patient felt good. On 04Feb2021, patient feels dragged out and a little shaky. Patient stated that in two weeks she has to go back for second. She and her husband got their first shot on Tuesday, 02Feb2021. They felt good the net day. Today she feels dragged out and a little shaky. Patient asked was that normal. The case was classified as non-serious. The outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This 78-year-old consumer reported in response to Non-HCP coversheet and questionnaire sent. Follow-up attempts are completed. No further information is expected.

itching; Rash; fatigue; joint pain; low blood sugar; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809/Expiry date: unknown), via an unspecified route of administration on 04Feb2021 at 11:00 AM in the left arm (at the age of 78-years-old) as single dose for COVID-19 immunization. The patient medical history included ongoing diabetes from 2000 and hysterectomy in the year 2000. The patient had received some other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No pre-disposing factors was reported. Follow up received on 21Apr2021, it was confirmed that on 27Feb2021 at 10:00, the patient experienced rash, fatigue, joint pain and low blood sugar (previously reported as, 05Feb2021, 12:00 AM, the patient experienced rash, fatigue, joint pain, and low blood sugar. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient was given advice and reassurance for the treatment of the adverse event). The patient had received treatment for rash. No treatment medication for received for events fatigue, joint pain, and low blood sugar. The patient was not hospitalized as a resulted of these events. Patient reported that the Doctor suggested taking benadryl for itching due to rash. The patient reported that she required a virtual visit to Physician office. It was unknown if the patient had any primary infection site. No culture was performed. The patient reported that she was fine now at the time of reporting. The clinical outcome for the event itching was unknown and the outcome of other events had recovered. Information on the lot/batch number has been requested. Follow up(21Apr2021): This is a follow up-spontaneous report from a contactable consumer received in response to Non-HCP letter via follow-up letter which included: Added patient's age at vaccination, medical history, suspect drug details (Lot number, Time of vaccination), updated event details (onset date and outcome), clinical course and narrative updated accordingly. Follow-up attempts completed. No further information expected.

This is a spontaneous report received from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9809) via intramuscular route of administration in left arm on 05Feb2021 at 09:45 (age at vaccination 78 years old) as single dose for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing Mother had heart issues, but she is passed away, ongoing panic attack the caller said that she has only had like 2 panic attacks in her life. She said that on 30Dec2021 she had a panic attack on the day of the vaccine, she had a light one on the way to get the injection, she said that she had COVID-19 previously and was diagnosed 05Jan2021 and was cleared so she took the vaccine, ongoing fatigue She said that her tiredness started during when she had COVID-19, but stated that she understands it was a symptom post COVID-19, ongoing gait disturbance She said that she may have been wobbly on her feet since she had COVID-19, but has gotten worse since the injection. There were no concomitant medications. On 05Feb2021 the patient experienced panic attack, her heart was racing/heart was racing to 132, unstable and wobbly on her feet, extremely tired and on unspecified date in February 2021 she said she feels like her eyesight has gotten worse, unstable and wobbly on her feet was reported as worsened/extremely tired was reported as worsened/she said she feels like her eyesight has gotten worse/and got very worse after vaccination. with outcome of unknown. The patient underwent lab tests and procedures which included electrocardiogram fine in 2021. The clinical outcome of the event panic attack, her heart was racing/heart was racing to 132 were recovered and unstable and wobbly on her feet, extremely tired were not recovered other events were unknown. Follow-up attempts are completed. No further information is expected.

nausea; tired/every day since receiving the product, she has had extreme fatigue; 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, Lot Number: Unknown), via an unspecified route of administration on 02Feb2021 (at the age of 78-year-old) as 2nd dose, single, in left arm for COVID-19 immunisation. The patient's medical history included high blood pressure. Concomitant medications included unspecified high blood pressure medicine. Patient had no other vaccines on the same day as the COVID vaccine. On 03Feb2021, the next day after receiving Pfizer COVID vaccine, the patient was very tired. On the third day, the patient became even more tired. Patient also had nausea, but that comes and goes. Fatigue does not go away and every day since receiving the product, she had extreme fatigue. Patient had been on high blood pressure medications for a long time, so she thought that could have done it. The clinical outcome of the event was tired/every day since receiving the product, she has had extreme fatigue was not resolved and the clinical outcome of the event nausea was unknown. Information on the Lot/Batch number has been requested. Follow-up attempts are completed. No further information is expected.

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.

aching all over her body everything was aching; bedridden; not feeling well; 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, formulation solution for injection, batch/lot number: EL3248; expiration date: Apr2021) via an unspecified route of administration administered in arm right on 28Jan2021 as single dose for covid-19 immunization (at the age of 78-years-old). Consumer said she had medical history of breast cancer and has undergone chemotherapy and radiation on an unknown date 2-3 years ago and unknown if ongoing and had ongoing blood pressure and thyroid from an unknown date. Patient has not had any positive test for Covid prior to the vaccine. Concomitant medication(s) included anastrozole taken for breast cancer from an unspecified start date and ongoing; furosemide; losartan; metoprolol and amlodipine all those were taken for blood pressure, start and stop date were not reported and warfarin, omeprazole, and vitamin D3 taken for an unspecified indication and levothyroxine taken for thyroid disorder and start and stop date were not reported. The consumer stated that she received first dose of vaccine and on 29Jan2021 she had aching all over her body and everything was aching, and she was just bedridden the 2 days till 30Jan2021 however she did not go outside of the house after that because of not feeling well on Jan2021. She further mentioned that aching was not like before, it was all over her body before, before everything was aching, now the aching was just on her arms, on right arm in particular. She further stated that she was scheduled for the second dose 18Feb2021 and first dose of the vaccine was given on her right arm because she has breast cancer on the left side. She wanted to ask if having side effects like this after the first shot was an indication the person may have had the covid prior to the vaccine and that was why there is a reaction like this after the vaccine and if the second shot going to be the same. The outcome of the event bedridden was recovered on 30Jan2021 and patient was recovering from the event of pain and outcome was unknown for the event of malaise. Follow-up attempts are completed. No further information is expected.

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.

Death 5/25/2021 Causes of death listed on death certififcate: 1. Acute Hypoxic Respiratory Failure due to Bilateral COVID-19 pneumonia 2. Bilateral Covid-19 Pneumonia 3. Covid-19 disease 4. Acute Renal failure, Metabolic Acidosis, Hyperkalemia, Acute Congestive cardiac failure

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.

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.

She thinks she has a sinus or allergy related ear infection; She thinks she has a sinus or allergy related ear infection; She thinks she has a sinus or allergy related ear infection; Ear feels plugged up; This is a spontaneous initial report from a Pfizer sponsored program . This consumer (patient) reported for herself that. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8734), dose 1 via an unspecified route of administration on 13Apr2021 09:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension (She was probably diagnosed 40 years ago with high blood pressure), ongoing thyroid disorder (She was probably diagnosed 45 years ago or longer with her thyroid issue), ongoing hip surgery (She had hip surgery two months ago). There were no concomitant medications. No Investigation Assessment. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. No Patients Medical History including any illness at time of vaccination. Family Medical History Relevant to AE(s): NO whole family has allergies. No Relevant Tests. The patient experienced she thinks she has a sinus or allergy related ear infection, and ear feels plugged up on 03May2021. It was reported that the caller is scheduled to get the second dose of the vaccine on 07May2021. She thinks she has a sinus or allergy related ear infection, but she is not sure. She was taking Coricidin, a cough and cold medication with high blood pressure. She stated she has high blood pressure. She took this yesterday morning at 9:30 AM and she did not take any more because she thought it might affect the shot. She stated she won't restart it until after the shot. She stated she is feeling better but does not know if this medication will affect the vaccine. It was reported that She was calling to see if she needed to stop this medication before getting her second dose. Confirmed caller has already stopped the medication. It was reported that she has had the ear infection for last four or 5 days, and she did not get it right after she had the shot. It was reported that she guesses it won't bother her, but it might bother him regarding contacting her physician. She never went to the doctor, or that she doesn't know if it is an ear infection or sinus drainage. She states her ear just feel plugged up. It was reported that it is not as bad as it was. She states she took 4 of those pills (Coricidine) and she got better but she still has the ear infection. She had to stop the pills because they could interfere with, COVID vaccine, and could not read the information on the box without glasses nor could she locate the NDC number on the box. Reporter seriousness for events: Unspecified. Patient was not visited Emergency Room or Physician Office for events. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.

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.

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.

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.

Pfizer COVID 19 Vaccine EUA Pfizer Dose 1 2/26/21 (EN6198) Pfizer Dose 2 3/18/21 (EP7534) COVID Positive 7/6/21 7/6/21: The patient presents to ED with diarrhea and Pt is 78 y/o female who presents to the ED complaining of chronic diarrhea onset since March that worsened over the last two weeks. Pt has had a cough as well. Pt has had a previous colonoscopy, but was told by GI that it was "too soon to have another." Pt denies any recent antibiotics, recent sick contacts, or recent travel. Pt states she is diabetic and her sugars have been 112 in the morning and 150 in the evening. Pt denies any abdominal surgery. Pt admits to cough, nausea and back pain, but denies vomiting, bloody stools, fevers, chest pain, shortness of breath, and abdominal pain aside from a pain that occasionally radiates down to her pelvic which she does not have currently. Pt denies a bowel movement today. Pt admits to both Covid-19 vaccine doses in March. Pt received the Pfizer vaccine.. The onset was chronic. The course/duration of symptoms is worsening. The character is not bloody. Risk factors consist of not recent antibiotic use, not infectious exposure and no recent travel. Associated symptoms: abdominal pain, nausea, cough, denies vomiting, denies fever, denies chest pain and denies shortness of breath. Patient seen examined emergency department for chief complaint of diarrhea that has been present for several weeks. Patient has seen her GI doctor. She states that stool cultures were obtained. Stool cultures reviewed, which demonstrated all negative stool cultures. Due to patient's persistent diarrhea, workup was obtained to rule out acute dehydration verses AKI verses electrolyte abnormality. Workup obtained demonstrates no acute findings. Patient was updated results. On reexamination, patient states he has had no episodes of diarrhea in the ED. This juncture, I believe patient is stable for discharge home with close follow-up with GI. Patient is agreeable. Return precautions are discussed, including change in mental status, decreased urinary output, or any other concerns..

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.

severe heartburn; Headache; Chills; joint pain; muscle aches and pains; Fatigue; 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; Lot Number: Unknown) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included osteopenia, breast cancer in 2010, hearing impairment. The patient was allergic to NSAID. Concomitant medications included ibandronate (MANUFACTURER UNKNOWN), niacinamide (MANUFACTURER UNKNOWN) and vit D (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 13Jan2021 at 10:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 03Feb2021 at 22:00, the patient experienced severe heartburn, headache, chills, joint pain, muscle aches and fatigue. No therapeutic measures were taken as a result of 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 heartburn, headache, chills, joint pain, muscle aches and fatigue were recovered with sequelae on an unknown date. No follow-up attempts are needed; Information about lot number cannot be obtained.

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.

For a week after my shot I was ok and then I started to get a cough. I though it was just my allergies. I then called my doctor to see what was going on and she tested me for Covid and Pneumonia and the results came back negative. She then tested me for bronchitis which came back positive.

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.

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

tested positive for Covid; shortness of breath; Cough; tested positive for Covid; This is a spontaneous report received from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of bnt162b2 (PFIZER COVID 19 VACCINE, Solution for injection, Batch/Lot Number: ER8727) intramuscular, administered in Arm Left on 02Mar2021 (at the age of 78-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing hypertension (ongoing). The patient concomitant medications were not reported. The caller states his mom and dad got the first Covid shot, they were due to get second shot today but caller cancelled the appointment, states his mom and dad both hospitalized and tested positive for the Covid virus after the vaccines. Caller states his dad is still in quarantine and mom is done with quarantine, he is hearing different things about when to get the second dose, everyone says to wait 90 days, getting mixed information, then he has heard 3 weeks is long enough to wait. Caller wants to know when his mom and dad can get the second dose of the vaccine after having the Covid infection. The mother got the first dose of the vaccine on 02Mar2021, states on 31Mar2021, she tested positive, caller clarifies his mother was not admitted to the hospital but was seen in the emergency room on 10APR2021 and released later that evening, his mother was told to follow up with the respiratory pulmonologist and remote patient monitoring, been taking oxygen saturations levels with pulse oximeter, shortness of breath and cough on 10Apr2021. The patient visits to emergency room on 10Apr2021. The patient tested positive post vaccination. It was unknown if patient was diagnosed with COVID-19 prior to vaccination, other medications in two weeks and other vaccine in four weeks. The patient received unknown treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Mar2021. The outcome of the event tested positive for Covid was unknown and rest events outcome was not recovered. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.

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.

COVID-19 Breakthrough disease which possibly resulted in death. Patient was fully vaccinated and was COVID-19 positive at time of death. Patient had symptom of cough that began 7/17/2021; the patient died on 07/20/2021. Patient tested positive for COVID-19 on 7/20/2021 at the long-term care facility at which they were a resident. I do not have death certificate details available at this time.

Nine days after the first dose of the vaccine on 02/01/2021 during the night I had a severe headache and I lost consciousness. I was taken to the hospital and I had had a stroke. I was hospitalized for four days and transferred to rehab on 02/05/2021 where I remained for 21 days. I was discharged from rehab on 02/26/2021. I also had in home therapy and continued to receive physical therapy until recently. I received the second dose of the vaccine in the hospital on 02/11/2021.

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; muscle pain; This is a spontaneous report from a contactable Nurse (patient). A 78-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0173, expiry: 31Aug2021), via an unspecified route of administration on 19May2021 (at the age of 78-year-old) as single for COVID-19 immunisation. Medical history of the patient included borderline multiple myeloma [had borderline multiple myeloma for 10-15 years], monoclonal gammopathy [MGUS, she had it for a while. there are periods of time when her protein was elevated making her borderline for myeloma], patient has had a couple rounds of prednisone to suppress the protein and has a positive ANC. Patient has a multitude of issues, severe allergies, COVID-19 in Mar2020 [had an antibody tested 3 months later and 6 months later that both showed no antibodies], diagnosed with sarcoidosis [in 1970 bust is in remission; tested regularly for sarcoidosis and patient thinks she might be having a gallbladder attack now], Russian flu [in 1988 and was in hospital for two weeks and almost died from that], was having a lot of immunology problems going on (immunocompromised patient), anaphylaxis (had 5 episodes of anaphylaxis), 9-10 episodes of total body hives, has been resuscitated twice, B-cell blood malignancy. Concomitant medications were not reported. Patient previously received hepatitis and tuberculosis vaccine and later discovered that she was a non-responder to hepatitis and TB. Patient previously received swine flu vaccination on an unspecified date in the 70s. Patient was having a lot of immunology problems going on and the doctor recommended her not get a flu vaccine. Patient has had no flu vaccine since swine flu in the 70s. Patient was allergic to over 30 drugs (unspecified). Immunologist did an immunology review of her allergies and prior vaccination problems before determining if patient could get the COVID vaccine. Physician wrote her a letter that said patient had to get the vaccine in a room with an IV ready and the defibrillator ready as well. On an unspecified date in 2021, after the first dose, patient was very ill, had a high fever, diarrhea for 6 days, severe muscle weakness/some weakness in her legs, muscle pain, joint pain, also had nausea and a headache that lasted about 2.5 weeks. 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. Patient was pretty sick for 10 days. Outcome of the event nausea, headache (duration 2.5 weeks) and diarrhea (duration: six days) were resolved on an unspecified date in 2021 and for other events were unknown.

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.

Sx onset 7/15/21 with cough, chills & muscle aches. Visited son, his wife & newborn in another location. Son and one other are both + cases. Tested on 7/26/21 which resulted as positive.

Sx onset 7/15/21 with cough, chills & muscle aches. Visited son, his wife & newborn. Son and DIL are both + cases. Tested on 7/26/21 which resulted as positive.

Itching; Fever; Malaise; This is a spontaneous report from a contactable nurse. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0191 and expiration date: not reported), via intramuscular, in Left Deltoid, on 06Jul2021 at 16:30 at the age of 78-year-old, as DOSE 2, SINGLE for covid-19 immunization at Urgent Care Center. Medical history included ongoing asthma, irritable bowel syndrome, gastroesophageal reflux disease and anxiety pre 2001. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0183 and expiration date: not reported), via intramuscular, in Left Deltoid, on14Jun2021 at 15:00, at the age of 78-year-old, as DOSE 1, SINGLE for covid-19 immunization at Physician Office and Felt very sick, experienced rash, Sore arm, nausea, fever and malaise. The patient's concomitant medications were unknown. The patient experienced itching, fever and malaise on 05Jul2021 (as reported). No treatment was received for the events. The outcome of the events was recovered in Jul2021. Follow-up attempts are completed. No further information is expected.

Every day since she got the vaccine she has had fog, lightheadedness, and dizziness worse than when she had COVID; Every day since she got the vaccine she has had fog, lightheadedness, and dizziness worse than when she had COVID; Every day since she got the vaccine she has had fog, lightheadedness, and dizziness worse than when she had COVID; fatigue; had so many naps; cutting the zinc in half because it made her terribly sick; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 at age of 78-year-old (Batch/Lot Number: EL3249) at single dose for COVID-19 immunisation; zinc (manufacturer: Nature Bounty), via an unspecified route of administration from an unspecified date (Batch/Lot Number: 529254-01; Expiration Date: Nov2024), at 50 mg daily for immunity. Medical history included COVID-19 in Sep2020 and her primary symptoms were different than the typical symptoms, she had the fog, lightheadedness, and dizziness, she healed up pretty good, but she would occasionally have a bout with it. Concomitant medication included colecalciferol (D3, Brand: Nature Bounty, lot number: 506697-01, expiry: Sep2023) taken for immunity. Additional vaccines administered on same date of the Pfizer Suspect were none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Prior vaccinations within 4 weeks were none. Back in probably 1958 she had a reaction to the Polio vaccine for immunization. She didn't remember the symptoms and they said to stay away from it. She had shingles vaccine for immunization and had no problem. The patient did not have lot number or expiry for the Polio Vaccine. She didn't have lot and expiry for the Shingles vaccine. She got the Shingles vaccine in 2019 because she had a friend that had shingles and it wouldn't go away. Her friend had not gotten the shingles vaccine. The patient's friend recommended that patient get the shingles vaccine. She had the opportunity to get the first vaccine on 11Feb2021 and she asked her doctor if she should do it with her having continued symptoms. The doctor said yes and for her to take Zinc and D3. So that is what she did. Every day since she got the vaccine she had fog, lightheadedness, and dizziness in Feb2021 worse than when she had COVID. She was fine the first 24 to 30 hours. When she woke up the next day in Feb2021 she was dizzy again. Then it has gone off and on. She can't even go grocery shopping without holding onto the cart an begin fearful. When she sat she was fine. She imagined she had fatigue. She had never had so many naps. The patient clarified that she lay down because of dizziness. The patient asked how does that relate to her getting the second one. That was the first one and they said the second one is worse. She is a caregiver and it can't get worse. They said the first shot is 85% effective is that enough and asked if that last for very long. She used to be 5 foot 2 inches. She saw her doctor on 25Feb2021 and doctor thought she should still have the vaccine. she was still leery. The 26Feb2021 is a better day, but she had felt real promise before. She took supplements. She thought she read that you shouldn't take anything for immunity. The patient asked if the zinc and D3 is considered for immunity because that is what the doctor told her to take it for. She had to cut the zinc in half because it made her terribly sick in 2021. It was 50mg, but since she was cutting it in half she is taking 25mg per day. She did not have any test or bloodwork since the vaccine. She wished the doctor would have done something when she messaged doctor on 25Feb2021 on app. She would feel better if someone else said she should get it. The events did not required a visit to emergency room. The action taken in response to the events for zinc was dose reduced. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.

patient stated she had a headache about 15 minutes after the vaccine. she took Tylenol and the headache was relieved

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.

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.

She received her first COVID vaccine 1/15. She tested positive for COVID 1/17 in outpatient clinic. Presented to ED 1/18 with a chief complaint of fatigue. admitted to Hospital Medicine for treatment of COVID-19 viral infection and was treated with supportive care. She was enrolled in the COVID-19 Home Symptom Monitoring program & discharged home 1/20/21

she thinks she lost an inch; mild headache; tired, feeling wiped out; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiration date unknown), intramuscular on the left upper arm on 08Jan2021 at 14:15 to 14:30 at a single dose for COVID-19 immunization. Medical history was not reported. There were no concomitant medications, no additional vaccines administered on the same date of BNT162B2 and there were no prior vaccinations within 4 weeks. The patient previously received flu vaccine and experienced a slight reaction to the flu vaccine, she does not recall when she had it. She got it in the supermarket (she was told one vaccine was super and one flu vaccine was regular, and she had the super vaccine and she thinks that is why she had the side effects). She does not know the name of the flu vaccine or have lot number to provide. The patient was calling about the COVID vaccine that she received a couple of days ago. She received the first dose on Friday, 08Jan2021. She wanted to call and report the side effects. She had a mild headache and was tired. She started feeling tired on Saturday, reported that she felt wiped out. It was reported that the events headache and feeling tired both started on Saturday (09Jan2021). It was also reported that she is about 5'1", she thinks she lost an inch, and that her headache is going away - it was not a major headache, not a migraine. She also took Tylenol as treatment. Her tiredness went away about 48 hours later, and confirmed she recovered completely as of that day. She was alarmed at first and she was wondering where the headache was coming from. She read the paperwork she received, and it is listed as a side effect. She was told that there may be some soreness when she went in to get the vaccine. The event tired, feeling wiped out resolved on 11Jan2021 while the mild headache was resolving and the outcome of the event she thinks she lost an inch was unknown.

Headache on front lobe of head; This is a spontaneous report from a contactable consumer (reporting for herself). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included high blood pressure and breathing problem. Concomitant medication included salbutamol (ALBUTEROL) taken for breathing problem and unspecified high blood pressure medications and blood thinners. The patient experienced headache on front lobe of head on 09Jan2021. The outcome of headache on front lobe of head was unknown. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Severe chills/shaking cold Severe body/muscle aches Day of/could not walk unassisted Severe nausea/throwing up Fever No appetite