Pfizer

Arm soreness / soreness in the arm and shoulder; Arm soreness / soreness in the arm and shoulder; Emesis; Nausea; This is a spontaneous report from a contactable nurse. This nurse reported different events for 6 patients. This is the sixth of the six reports. A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 at a single does in the left arm for COVID-19 immunization. Medical history included dementia from 10Mar2020 and ongoing. The patient's concomitant medications were not reported. The patient experienced arm soreness (soreness in the arm and shoulder), emesis and nausea on 01Jan2021. The patient received paracetamol (TYLENOL) for the soreness, nothing for the emesis and nausea. The events were all resolved on 01Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.

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

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

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.

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

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.

Unsteady - 2 staff members accompanied resident to ambulate, resident was immediately lowered to sitting position in chair as resident experienced a change in LOC- approx. 5 sec. T- 99.3 O2 at 90% and pulse 44. Regained orientation X 2, began vomiting and diarrhea,. 911 transported to hospital, Family aware

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.

Within 5 minutes I became nauseated, then l began growing weak, alerted staff and they started monitoring my blood pressure which had gone up to 159 (usual is around 120), began uncontrollable shaking. After about 1 1/2 hours my blood pressure lowered to 136 and I was transported by wheel chair to car to return home.

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.

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

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.

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.

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,

I received this shot on Jan 30 and have been sick ever since. I Threw up for several days and and still sick to the stomach. I had severe diarrhea and my bowels are still messed up- they are light yellow verging on white. I have been having migraines and am very weak and shaky. Pain at injection site is trivial. Pain through out my body is not. I am often dizzy.

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.

I have been really nauseous and dizzy most of the day; I have been really nauseous and dizzy most of the day; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ELT284), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunization. Medical history included being diabetic, glaucoma. Concomitant medications were not reported. Patient stated that she had the vaccine on Tuesday (19Jan2021) she was reading over the 'notary' the side effects to be expected and that list one here it say, it could be an allergic reaction but it says that would happen after few hours after the injection but she got it on Tuesday, yesterday (20Jan2021) she was fine. On 21Jan2021, she had been really nauseous and dizzy most of the day, patient wondered whether that was something that she should expect you know would happen because the list here says dizziness and weakness is one of the side effects so is that just something that last for a while and then go away or she should be concerned about. 09Feb2021 is the date that would be for her second shot. Outcome of the events was unknown.

Nausea with vomiting and dizziness; vomiting was constant when it began @ 2100. patient then came to er, received fluids dizziness and nausea decreased in ER

Pt developed nausea, dizziness, and chest pain during her 15 min observation period. Pt was clutching her chest and stated that she felt her heart racing. 911 called and pt transported to ED.

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

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.

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.

She had emesis within 30 minutes of 2nd dose of vaccine. Her nausea continued for 1 hour with abdominal and chest discomfort. She was taken to ED. Her vital signs remained stable. All work-up for cardiac event was negative. This was determined to be a vaccine reaction leading to nausea with 1 episode of emesis.

Room was spinning; Dizzy; Nausea; This is a spontaneous report from a contactable consumer (patient). This 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 26Jan2021 (at 12:00) at a single dose on the left arm for COVID-19 immunisation. Relevant medical history included arthritis, blood pressure and allergies. Relevant concomitant medications included atorvastatin, furosemide and metoprolol. On 27Jan2021, the patient woke up in the morning the room was spinning and she was so dizzy she couldn't even get up. She remained dizzy for quite a while - she was not sure if she should receive the next dose. She also had nausea. The patient was not treated for the events. Pre and post vaccination COVID tests were not performed. The patient had recovered from the events on unknown date in 2021. Information about Lot/Batch number has been requested.

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.

Within 15-minutes of vaccination, the patient reported dizziness, lightheadedness, and nausea. EMS evaluated patient on-site and administered 4mg Ondansetron PO. Patient was hypertensive (156/84) in transport to Emergency Department. Patient remained hypertensive in ED. Discharged from ED with diagnoses of dizziness, nausea, resolved, secondary to vaccination.

she hasn't been eating like she should; lost eye sight for 5 minutes, everything was grey; could hear her niece, but that her niece sounded far away; very nauseated/wanted to throw up but couldn't; This is a spontaneous report from a contactable consumer, reporting for herself. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 29Jan2021 14:00 at a single dose to prevent getting COVID-19. Medical history included cholesterol, high blood pressure, arthritis, medications for her heart, and medication for her stomach. Concomitant medication included amlodipine for high blood pressure and atorvastatin for cholesterol. The patient has been on amlodipine in a good while, 7-8 years and atorvastatin for 5 years. The patient had the COVID shot on Friday, 29Jan2021 at 14:00, and about 4 hours afterward, she had a bad experience. She became very nauseated and lost her sight for 5 minutes. Everything was grey. She was wondering if there is anything she can take afterward. She was scheduled for her next one on 19Feb2021. She was wondering if she will experience the same thing. She has lost about 11 pounds because she has been on a diet. She gave up sugar. After getting the vaccine, she was on her way back. She began to feel very nauseated in the car. Then, all the sudden she wanted to throw up, but couldn't. She couldn't hear her niece or say anything to her. She clarified she could hear her niece, but that her niece sounded far away. She couldn't respond. She rolled the window down to get air in her face. She hadn't eaten. In about 25-30 minutes got better. Since then, she hasn't been eating like she should, so she was still a little nauseated. It has improved though. She got the vaccine in her left arm. Her right arm is mostly metal. She decided to get it because she is over 70 and wanted to prevent getting COVID-19. It was also reported that she was also on an arthritis medication, medications for her heart and a medication for her stomach. She has had no problems with those medications though. The patient underwent lab tests and procedures which included weight: lost on an unspecified date. She has lost about 11 pounds because she has been on a diet. She gave up sugar. The outcome of the events "lost eye sight for 5 minutes, everything was grey", "could hear her niece, but that her niece sounded far away" and "very nauseated/wanted to throw up but couldn't" was recovered on 29Jan2021 while the outcome of all other events was unknown.

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.

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.

Rectal Bleeding; 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: EN5318, expiration date not reported), via an unspecified route of administration on the right arm on 02Feb2021 10:45 at single dose for COVID-19 immunization. Medical history included osteoporosis and allergic reaction to penicillin. The patient is not pregnant. The patient has no prior COVID vaccination. There was no other vaccine given within four weeks. Concomitant medication included atorvastatin, calcium, magnesium. The patient experienced rectal bleeding on 03Feb2021 09:00. Patient reported that she had her first shot yesterday morning and today when she went to the bathroom she has rectal bleeding, bright red blood, which is not normal for her. The patient was not tested for COVID post vaccination. Outcome of the event was unknown.

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

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.

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.

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.

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

Severe dizziness & nausea. Needed help standing & walking. B/P normal for her. Went to bed & slept for about 4 hrs. Just mild dizziness on waking. That resolved in a few hrs. No symptoms since then.

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

Tinnitus spiked up quite a bit /tinnitus was reported as worsened /her tinnitus increased a great deal. It increased in loudness; arm was sore; stomach ache; upsetting and distressing; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration at 13:30, on right arm, on 25Jan2021, at single dose for COVID-19 immunisation. The patient relevant medical history included heart condition, she is mostly allergic to antibiotics (She has allergies to several medications; Specific antibiotic names not provided), blood pressure, anxiety, thyroid (thyroid disorder), urinary tract health, I have had tinnitus for 7 years and Bones (bone disorder) and of them were ongoing. The patient concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder and ongoing at 50ug, daily, hydrochlorothiazide tablet for blood pressure and ongoing at 0.25mg (half tablet) once a day, valsartan(DIOVAN) for blood pressure ongoing at 80mg once a day, verapamil for heart issue ongoing at 100mg, metoprolol tartrate for heart, ongoing at 25mg twice a day, alprazolam (XANAX) for anxiety ongoing at 0.25mg, once a day, d-mannose for urinary tract health ongoing at 300mg once a day, vitamin d nos for bones ongoing at 50ug daily, calcium carbonate (CALTRATE) for bones at unknown dose once day, ubidecarenone (COQ10) for heart ongoing at 200mg, magnesium for the heart. It was reported that patient got tinnitus after taking an antibiotic and had for 7 years. After taking the first dose on Monday (25Jan2021), the tinnitus spiked up quite a bit on 27Jan2021 (noticed when she woke up at about 08:00 in the morning). Tinnitus got very much louder, and patient thought that it was from vaccine. Tinnitus increased a great deal. It increased in loudness and was reported as worsened. On an unknown date in Jan2021, the patient arm was sore and got better. The patient also had little bit of a stomach-ache at first and that got better as well on an unknown date in Jan2021. The patient thought that the tinnitus would return to my normal level of loud. The patient reported that it's very upsetting and distressing on an unknown date in Jan2021. The patient was worried about getting the second shot. The patient also stated that had allergic reactions to many drugs and did fine with the vaccine in terms of anaphylaxis. It was reported that prior vaccinations within 4 weeks was none. It was reported that patient had not administered additional vaccines on same date of pfizer suspect administration. The outcome of the events tinnitus spiked up quite a bit /tinnitus was reported as not recovered /her tinnitus increased a great deal. It increased in loudness was not recovered, upsetting and distressing was unknown, stomach-ache and arm was sore was recovering.

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

appendicitis; intense abdominal pain; 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) via an unspecified route of administration in the left arm on 06Feb2021 15:45 (03:45 PM) at a single dose as Covid vaccine. Medical history included gastrointestinal distress at the time of incident. The patient had no known allergies. Concomitant medications included cyanocobalamin (B12), calcium, levothyroxine sodium (LEVOXYL), lisinopril, and ergocalciferol (VIT D). The patient developed intense abdominal pain on 08Feb2021 10:00 AM. She went to the ER on 09Feb2021 and a CT scan on 09Feb2021 which revealed that she had appendicitis on 08Feb2021 10:00 AM. The patient was hospitalized for the events from 09Feb2021 to 13Feb2021 (4 days of hospitalization). Treatment for the events included intravenous antibiotics. The patient had no Covid prior to vaccination. Additional lab data included Covid test type post vaccination Nasal Swab with negative result on 09Feb2021 (Covid tested post vaccination). The outcome of the events was recovering. Information on the lot/batch number has been requested.

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.

She developed nausea, vomiting that has persisted from 2/11/21 (first visit to see me) until today 3/4/2021 (second visit)

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.

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

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.

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.

Developed N/V ~2 weeks after 2nd covid vaccine. Presented to PCP, labwork revealed AKI and hyperkalemia. Sent to ED. Admission lab included SCr 8.55 mg/dL and K+ 5.7 mmol/L. Repeat K+ level 7.0 mmol/L (6 hours later). Pt admitted, vascath placed, emergently dialyzed. Further work up revealed positive anti-nuclear antibody, positive anti-nuclear antibody titer, and elevated glomerular basement membrane antibody. High dose steroids (methylprednisone 1g iv qday x 3 days) started for presumed vasculitis. Renal biopsy performed, results c/w severe crescentic acute glomerulonephritis. Treated with rituximab 375mg/m2, subsequently transferred to another facility for plamapheresis.

Within 15-minutes of vaccination, the patient reported dizziness, nausea, and chest pain. EMS evaluated the patient on-site. Patient was found to have orthostatic hypotension, hypoglycemia, and was near-syncopal. EMS administered 400mL of normal saline and 15g oral glucose. EMS transported the patient to Emergency Department. In the ED, the patient was hypertensive (163/73). EKG demonstrated NSR, rate 67 bpm, no ST-T changes, no ectopy, normal PR & QRS intervals. CBC/CMP was unremarkable. Patient noted improvement and was discharged with a diagnosis of a probable vasovagal event.

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.

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.

DEATH-My Mother received her second Pfizer vaccine on Thursday, February 18, 2021 and died three days later on Sunday, February 21, 2021, after being admitted to the intensive care unit at Hospital. After developing an adverse reaction that started with nausea and then got progressively worse, including vomiting blood, Mom was rushed to the emergency room where she was tested for Covid-19 due to hospital policy (neg. result) and admitted to the intensive care unit. Mother died on Sunday, February 21, 2021. NOTE: Mother was doing well with her heart and renal conditions until she received the second dose of the Pfizer Covid-19 vaccine on February 18, 2021, directly or indirectly causing her death three days later on February 21, 2021. It is unfortunate that we are all advised (sometimes ill advised), particularly those with underlying conditions, to get vaccinated without the benefits of knowing when the vaccine can cause more harm than good. For obvious reasons, the approval of covid vaccines was rushed and thus the Pfizer and Moderna Studies are not thorough and lack in data to support an all call for everyone to get vaccinated in the name of herd immunity. Without the appropriate data, My Mother is DEAD! Sadly, there are probably more unreported deaths caused by the vaccine. While you have immunity from liability, you still have a moral obligation to collect data and advise accordingly. My goal is to save lives by sharing my mother?s personal experience and death after receiving the vaccine with everyone I know through every available resource. It is unconscionable that I have to shoulder the burden of getting the facts out about your vaccine so that individuals with underlying conditions can make a proper, informed decision about getting vaccinated. Sadly, I receive over 100 questions a day via social media from individuals inquiring about whether or not they or their loved ones should opt for the vaccine. I am not a medical professional?this is your job! Until you assume responsibility, I will continue advising anyone with heart and/or renal conditions to stay away from any and all covid vaccinations. Instead of the massive all call for vaccinations, we need further information and data from additional studies that will give more insight as to when the vaccine can cause more harm than good, as in My Mother?s case.

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

Patient presented to the emergency room with chief complaint of right side abdominal pain and and nausea. Primary problems were found to be right ureteral stone and urinary tract infection. Patient was admitted on 3/13/21 and while doing rapid COVID-19 testing on 3/13/21, was found to be positive. Patient denies any contact with COVID-19 and presented with no symptoms to suggest COVID-19 illness. Patient denied any fever, headache, loss of senses of taste or smell, muscle aches, fatigue, vomiting, constipation, or diarrhea.

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; 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.

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)

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.

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.

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.

EUA Pfizer -BioNTech vaccine 3 days after vaccine, patient complained about facial droop. She saw her PCP who diagnosed her with Bell's Palsy. She was prescribed acyclovir and prednisone. 4 days after the vaccine, she began to feel dry eyes, and difficulty swallowing. She was advised that symptoms will improve with time and steroids and to return to the ED if she experiences voice changed or cannot tolerate liquids.

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

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.

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.

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

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

severe gas; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EL9264), via an unspecified route of administration, in Arm Left on 09Feb2021 as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced severe gas and diarrhea on 13Feb2021 with outcome of not recovered. The patient reported that severe gas started on 13Feb2021. It would last about an hour and then she would go to the bathroom and have diarrhea. Severe gas and diarrhea have been intermittent, and they continued throughout. The patient received the second dose on 02Mar2021 (Lot EN6205) in left arm and about 4 days later she had the same gas effect. The patient mentioned her stomach swelled and had loud gas which was shocking to her. She continues to state that she was basically a vegetarian that ate well and did not normally have diarrhea issues.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021269680 same patient, different dose/AE

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.

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.

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.

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.

Received dose and tolerated it well. Over last week increasingly SOB, diarrhea and weakness. Of note family contact tested positive for She was admitted to the hospital - c Patient admitted to COVID unit as PUI, tested positive for COVID on 3/7. Required O2 and intubated with ICU admission. She remained intubated for 12 days. Her ICU course was complicated ARDS with severe hypoxemia, A.fib with RVR, mod-severe PFO with R to L shunt, spontaneous intraperitoneal bleed, septic shock, renal failure and ultimately multi-organ failure. Family made decision to transition to comfort measures only. She died shortly after extubation.

Pfizer-BioN Tech COVID-19 Vaccine EUA: Swelling in mouth/lips, severe itching (all over, especially legs, thighs, back, arms, scalp, eyebrows and in nostrils, sensitivity to sound, elevated blood pressure, swelling in ankles, nausea

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.

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.

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.

Started to feel dizzy; nauseous in evening received shot; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on the left arm 13Feb2021 at 2:15pm as a SINGLE DOSE for COVID-19 immunization. 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. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. Patient other vaccines within 2 weeks prior to the COVID vaccine included tamsulosin hydrochloride (FLOMAX), ondansetron (ZOFRAN), furosemide, oxycontin and oxycodone. The patient's medical history included bladder issues, celiac disease and allergy (reported as known allergies Yes 17 rxs). On 13Feb2021 at 11pm, the patient started to feel dizzy and nauseous in the evening received shot. The patient reported that the symptoms got progressively more pronounced. It was reported that patient did not receive any treatment for events. The outcome of the events was not resolved.

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.

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.

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.

On April 1, 2021 I woke up with pain in my left hip. As the day went on it got much worse and the nausea started to the point where my husband had to take me to the ER . They gave me some pain medicine, nausea medicine and did a cat scan of my abdomen. Nothing was found and I was sent home. April 4th the pain got so severe and the dry heaving to the point where blood came out. Again I went into the ER this time by ambulance because I was so weak at that point where I couldn?t walk. Again they gave me pain medicine and nausea medicine along with prednisone. It took about a week to recuperate and now I have severe tinnitus.

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.

Started with loose stools on 2/25/21- 2 days after receiving 2nd dose, has had many blood tests done, colonoscopy, x-rays & CT scan ordered. Continues with liquid-diarrhea stools

4/11/21 Extreme vertigo, nausea, severe vomiting. 4/13/21 Vertigo and nausea persisted, vomiting subsided. 4/15/21 Vertigo, nausea, difficulty swallowing. 4/16/21 Completely unable to swallow. Taken to ER. Upper esophageal sphincter spasm resulting in inability to swallow. 4/27/21 Laryngospasms began intermittently progressing to continuous on 4/28/21 severely compromising ability to breathe. Intubated and placed on ventilator.

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.

Patient completed 2-dose Pfizer series on 1/31/21 and passed away on 2/13/21. Pt presented to ER on 2/11/21 with SOB, weakness, diffuse abdominal pain and diarrhea that started that day. Pt tested positive for COVID and was transferred out to a higher level of care. 1st dose: 1/5/21, 2nd dose: 1/31/21

This 76 year old female received the Pfizer Covid shot on 2/15/21 and went to the ED on 4/6 /21 and was admitted on 4/6/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified GI Bleed

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.

Not focusing very well; Totally dizzy and unable to walk very well because of the dizziness; Totally dizzy and unable to walk very well because of the dizziness; Nauseous; This is a spontaneous report from a contactable consumer (patient) for herself. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot Number: EW0150), dose 1 via an unspecified route of administration, administered in Arm Right on 12Apr2021 13:30 as a single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus: Diabetic. Concomitant medications included metformin; acetylsalicylic acid (ASPIRIN); calcium carbonate, colecalciferol (VITAMIN D 2000), and Cholesterol Pill, Blood Pressure Pill (unspecified); all taken for an unspecified indication, from an unknown date and ongoing. The patient experienced totally dizzy and unable to walk very well because of the dizziness on 13Apr2021 with outcome of recovered on 14Apr2021, nauseous on 13Apr2021 with outcome of recovered on 14Apr2021, not focusing very well on 15Apr2021 with outcome of not recovered. Treatment included drinks a lot of fluids. The report is not related to a study or programme. She received the vaccine on Monday 12Apr2021 at 13:00. She drank a lot of fluids and ate and went to bed and slept a full 8 hours straight. When she woke up, she was totally dizzy and unable to walk very well because of the dizziness and she had a nauseous feeling, but never vomited. Stated that was on Tuesday and lasted most of the day, sort of subsiding towards evening. When she woke up, she was still dizzy. She was not focusing very well. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No AE require a visit to Emergency Room or Physician Office. There was AEs following prior vaccinations. No Prior Vaccinations (within 4 weeks). No vaccines were administered on same date of the Pfizer Suspect. No follow-up attempts are needed. 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.

Pt presented with coffee ground emesis and acute st elevation myocardia infarction. She was DNR. She was admitted and expired in a few hours.

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.

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.

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.

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.

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.

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.

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.

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 had high Blood pressure yesterday; Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose; started getting hungry; she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs; swelling under her eyes/eyes started getting swollen; face was swollen; Eye infection; face felt tight; 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 MRNA VACCINE, Lot: EM9810; NDC number: Not Provided Expiry Date: Unknown) via an unspecified route of administration on the left arm on 06Feb2021 at 8:31AM (at the age of 76 years), as a 2nd dose, single dose for COVID-19 immunization. The patient medical history included disc protruding (diagnosed before the covid vaccine in Jun2020 or around that, she recalls having several months of MRI's in 2020) and high blood pressure. The patient's concomitant medications included Epidural Shot (Verbatim) for Protruding Disc Patient on 27Jan2021 (she had to go to the doctor in the clinic and get epidural shot in the back at the disc thats protruding). Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EL3249; NDC number: Not Provided, Expiry Date: Unknown) via an unspecified route of administration on the left arm on 16Jan2021 at 12 PM (noon) as 1st dose, single dose (at the age of 76 years) for COVID-19 immunization. Clinical course: She took second dose of Pfizer Covid Vaccine on 06Feb2021, though she had no reaction initially. A week later from vaccination on Feb2021, she then began to notice her eyes started getting swollen couple days after, she then felt like her eyes felt like they were closing, then she saw her whole face was swelling, it looks like she had Chipmunk cheeks. She went to the doctor hoping it would go away, she was prescribed Benadryl and a decongestant as treatment. She takes Benadryl three times a day and the decongestant in the morning and her face is still swollen. It started with the eyes and the bag under the eyes, that was the first thing she noticed. She laughs and though she initially had an eye infection. She just wants to know if there is any other reports of this happening, or how to get rid of it, this has been there since she got her second dose on the 06Feb2021 since like 10Feb2021. After the second vaccine on 06Feb2021 around that time an hour later, she was on the way home and started getting hungry, she thought that was a symptom as well as her arm hurt a bit. She was starving till Monday got up 2AM, 6AM ate all day Sunday and Monday ate all day, as reported "all she knows is she was craving a crab sandwich." Her Eyes swelling started a couple days later and the Face swelling was either the second week or same time, she just recalls looking at the eyes. She recalls telling her son her face felt tight in Feb2021. At the doctors appointment she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs, she is a small girl. The Appointment with the doctor was yesterday (15Mar2021), they prescribed Benadryl. Patient clarified that she was not Prescribed Zyrtec, it was a decongestant but she does not know the name of it. The Druggist however told her she could take another medication also. As reported "The eye swelling and face swelling, at the moment she look like she been drunk, her face is plentiful, she is still swollen, her lids are not bad, but it is ongoing, it has gotten worse because prior she didnt even know it was there and its showing more now. She asked son if he thought she was swollen because she feels tight, over the weekend her face being swollen was noticeable, she is noticing people are pointing it out now." She adds her arm did not hurt with first dose. Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose and the next day (07Feb2021). She thought initially that she didn't have any side effects. She had High blood pressure yesterday (15Mar2021), but that usually goes up and down for her and nothing new. It was reported that, a week later, patient experienced swelling under her eyes, face was swollen, eye infection and face felt tight on Feb2021; hunger and vaccination site pain on 06Feb2021 (reported as the day she got this dose); hypertension on 15Mar2021 (reported as yesterday). Patient would like to know if swelling of the face is a reported side effect from the covid vaccine, how long her side effects from the covid vaccine will last and asking for suggestions on how to get rid of the side effects from the covid vaccine. The outcome of event vaccination site pain was recovered in Feb2021 (duration of event was 2 days), swelling under her eyes, face was swollen was not recovered while outcome of other events was unknown. Follow-up attempts are completed. 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

A few days after I got the shot I started having night sweats, nausea. The night sweats went away until I got my second vaccine. Now I have them every night. They are not as bad. My doctor put me on medicine. I have fluid around my heart. Pericardial effusion is what I was diagnosed with. I also have small cell vasculitis. My red blood cell dropped.

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.

It was the worst last Friday night/ feels it in both breasts. It is getting worse; had subtle gas pains that go from her shoulder to her elbows and sometimes she feels it in her left shoulder/ feels like the gallbladder pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Left on 22Jan2021 at 07:30 (at the age of 76 year) as single dose for covid-19 immunisation at hospital. Medical history included ongoing Atrial fibrillation, thyroid problem and asthma. Patient had gallbladder concerns from twenty years ago. Gallbladder removed years ago. Patient's family history includes heart problems and diabetes. Concomitant medication(s) included apixaban (ELIQUIS) taken for atrial fibrillation, digoxin (DIGOXIN) taken for atrial fibrillation, fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma, levothyroxine sodium (SYNTHROID) taken for thyroid disorder, metoprolol tartrate (METOPROLOL TARTRATE) taken for atrial fibrillation, prednisone (PREDNISONE) taken for asthma and vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication from an unspecified start date and ongoing and Potassium. Patient was not received any other vaccine prior four weeks of vaccination. She states two weeks ago on Friday she got her first dose vaccine COVID 19 vaccine on 22Jan2021 0730 AM in the left arm. Reports a week later on 29Jan2021 she had subtle gas pains that go from her shoulder to her elbows and sometimes she feels it in her left shoulder too. She added it feels like gas pains and it feels like the gallbladder pain she had when she had her gallbladder removed years ago. She added did not feel it every day It was the worst last Friday night. And she also feels it in both breasts It is getting worse. States she didn't have this until she got the shot, she was going to call her doctor, but she thought Pfizer would have more information about other people reporting this. She was scheduled to receive the second dose on 17Feb2021 at 07:00AM. Seriousness reported as non-serious by reporter. The outcome of the events was reported as not resolved and unknown for It was the worst last Friday night/ feels it in both breasts. It was getting worse. 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.

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.

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.

secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse 46 , cyanotic lips, limp, resps 11. pt passed at 2:30

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.

tremor; insomnia; intense itching; loose stools; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was reported as unknown) via an unspecified route of administration on 26Feb2021 at 10:30am (at the age of 76-years-old) in left arm as dose number unknown, single for covid-19 immunization at Hospital. Medical history included breast cancer and known allergies as IgG reactions to many substances both from an unknown date and unknown if ongoing. No other vaccine taken on same date. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks. Concomitant medications received within two weeks included pregabalin (LYRICA); ascorbic acid (VITAMINS C); colecalciferol (VITAMIN D [COLECALCIFEROL]); melatonin (MELATONIN) and fexofenadine hydrochloride (ALLEGRA) all taken for an unspecified indication, start and stop date were not reported. The patient experienced delayed reaction two days after vaccination which included intense itching, insomnia, loose stools, and tremor on 01Mar2021. The patient received treatment for the adverse events occurred. The outcome of the events was Recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

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 Vaccine EUA Nausea, Diarrhea, Heart Burn. Heartburn. Diarrhea beginning Saturday, July 24 around 6:30 AM.

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.

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 20 minutes after the injection I started to feel like I was going to vomit, got nauseated and dizzy.. I had left the site after the 15 minute wait, and since I read that Nausea was one of the side effects, I thought it would go away. I waited another 30 minutes in my car at a parking lot outside the hospital in case I really couldn't drive home. I did drive home , but have been feeling the same nausea every day and some dizziness and diarrhea for the past 11 days. I called my doctor and she said to take it easy, drink fluids, eat light and that I could get the second shot. I am not sure if this is just a reaction or a severe allergic reaction and I need advice and feedback on that issue.

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.

admitted to hospital on 21 Jan 21 with Acute cystitis without hematuria; Cardiovascular disease; Diarrhea; ST segment depression; Syncope, unspecified syncope type Discharged on 26 Jan 21

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...

10:55 "I feel a little woozy" HR - irregular; dry; "feelin' a little nauseated" Neuro - intact; monitoring sats & b/p. 1103 - Nausea - gone! good V/S. Stayed with patient, V/S equalized and pt slowly got better.

Diarrhea; Upset stomach/stomach was jumping around; she woke up during the night after her stomach was jumping around yesterday; her arm was not real sore, which she was surprised. She says that if she touches the injection site she can feel it; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), via an unspecified route of administration in the left arm, on 16Jan2021 11:30, at single dose, for COVID-19 immunization. Medical history included ablation and watchmen procedure (successful) both in 2020, atrial fibrillation (A-fib) and sensitive stomach. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN 81 mg, lot number: NAA80DX, expiry date: Aug2021). The patient reported that she had her first dose of the vaccine this past Saturday (16Jan2021), and she did not have adverse events, but she was having some upset stomach on 17Jan2021 and diarrhea on 18Jan2021 and would like to know if this could be a side effect. She stated she woke up during the night of 17Jan2021 after her stomach was jumping around. She stated she has a sensitive stomach, anyway, normally; and her arm was not real sore, which she was surprised. She said that if she touches the injection site, she can feel it (pending clarification), but it is not throbbing, aching, or swollen. She stated that she was not sure if it could be the spaghetti they had for dinner, but this morning (18Jan221) she had some diarrhea. When asked about treatment, she said she didn't take anything for this because she doesn't like to take medicine, and if it is from the vaccine it should go away in a day or so but her diarrhea stayed about the same and has not gotten any better or worse. She also noticed the paperwork that said don't take Ibuprofen, Aspirin, or blood thinners, and mentioned she takes baby aspirin every day, she wanted to know if that was okay. The outcome of the event diarrhea was not recovered; and the remaining events was unknown.

Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: CO87750), via an unspecified route of administration, in the left arm on 20Jan2021 at 10:45 AM (at the age of 77-year-old) as a single dose for COVID-19 immunization. Medical history included ongoing arthritis, congestive heart failure, open heart surgery in 2010. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jan2021, the patient experienced diarrhea. The patient reported "this morning" she had diarrhea. She had it again within the hour. The clinical outcome of diarrhea was not recovered.

About 20 minutes after the vaccine was administered I felt a wave of nausea and felt like I was going to vomit; then I felt dizzy; About 20 minutes after the vaccine was administered I felt a wave of nausea and felt like I was going to vomit; diarrhea; 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: EL324) on 14Jan2021 at 10:00 at single dose via an unspecified route of administration on arm left for COVID-19 immunization. Relevant medical history included GERD, disc disease, meningioma, diverticulitis, panic attack and allergy to Macrodantin, Levaquin and Bactrim. Concomitant medications included metoprolol, atorvastatin, omeprazole and alprazolam. On 14Jan2021 about 20 minutes after the vaccine was administered patient felt a wave of nausea and felt like she was going to vomit, then she felt dizzy. Patient waited another 30 minutes before driving home hoping it would subside. Patient informed she have been nauseated, dizzy and had diarrhea on and off for 9 days. She didn't called her doctor yet or notified anyone at the site hoping it would pass, as she knew that nausea was one of the side effects. The patient was not treated for the events. At the time of the reporting the patient had not yet recovered from the event.

Patient immediately felt dizzy, lightheaded, faint after received vaccine, also experienced nausea. Monitored for approx 1 hr until patient felt better/ "back to normal." Vitals signs remained stable and SaO2 WNL throughout observation period. Patient was transported in w/c from waiting area to observation bay and laid on gurney, bottle of water provided, snacks provided. Pt remained A&O throughout observation period. Husband present.

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

Severe vomiting and diarrhea 2 hours following vaccination; Severe vomiting and diarrhea 2 hours following vaccination; 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, solution for injection, batch/lot number and expiration date were not reported), via an unspecified route of administration at the left arm on 20Jan2021 at 16:00 (04:00 PM) at single dose for Covid-19 immunization, administered in a hospital. The patient was not pregnant at the time of vaccination. The patient's medical history included prior malignancy s/p chemo and targeted therapy (last dose approximately 3 years ago). The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. 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 not been tested for COVID-19. The patient experienced severe vomiting and diarrhea 2 hours following vaccination on 20Jan2021 at 18:30 (06:30 PM). Therapeutic measures were taken as a result of the events which included ondansetron, oral fluids, and lorazepam. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

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

Upset stomach; 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, Batch/lot number: EL1283), via an unspecified route of administration on 25Jan2021 at single dose, left arm for covid-19 immunization. Medical history included hysterectomy from 1993, breast cancer from 28Feb1988 to an unknown date, she had three stents put in on 07Jan2021. Additional Information for Other Conditions reported as they did a mastectomy and had had a prosthesis for 30 years; they took out 18 lymph nodes and still suffers from her right arm being; she had right breast cancer. She shrunk before the vaccine. She had a hysterectomy and breast cancer and could not take any hormones. She guessed that was the reason why she shrunk. She was 5'3" or 5'4" and used to be 5'6". The patient's concomitant medications were not reported. The patient took the shot this morning(25Jan2021). She had an upset stomach on 25Jan2021. She messed her pants. She had three stents put in on the 07Jan2021. This was prior to the vaccine. She ate potato soup a little while before. This was her first dose. Treatment reported as none. The outcome of the event was unknown.

"I started to feel strange". "Funny taste in mouth, dizziness, difficulty swallowing, and not thinking clearly, history of reaction to high dose flu shot, HTN

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.

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, 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.

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.

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.

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.

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

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

This is a spontaneous report from a contactable healthcare professional. A 77-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 28Jan2021 13:30 at a single dose for covid-19 immunization. Medical history included diabetes type 2 and neuropathy (reported as neuropothy). The patient experienced Upper and middle back severe pain, nausea, vomiting, diarrhea; all on 01Feb2021 04:00 AM. The outcome of the events was unknown. Information on the lot/batch number has been requested.

RECEIVED PFIZER COVID-19 VACCINE 1ST DOSE ON 02/20/21. REPORTED TO ER ON 02/21/21 WITH COMPLAINTS OF ABDOMINAL PAIN AND NAUSEA AND VOMITING. DAIGNOSED WITH EPIGASTRIC ABDOMINAL PAIN, ATYPICAL CHEST PAIN, URINARY TRACT INFECTION WITH OUT HEMATURIA, AND HIATAL HERNIA. DISCHARGED HOME WITH INSTRUCTIONS FOR FOLLOW UP APPOINTMNET WITH PCP, GI, GENERAL SURGERY, AND CARDIOLOGY.

started having nausea, vomiting, abdominal pain after 2nd vaccine. Went to urgent care, then sent to ER and admitted to hospital on 2/22/21

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.

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

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

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.

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

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.

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.

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

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.

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.

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

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.

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.

Patient presented to ED with chief complaint of sudden onset dizziness, epigastric pain and generalized weakness, symptoms happened the day before yesterday, resolved, she noticed when she is trying to do any activities she gets heart fluttering. Epigastric pain noted in ED. Troponin Elevated, heparin IV started for possible NSTEMI. Patient is currently admitted.

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.

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

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)

On 3/11/2021 the patient presented to the ED for rectal bleeding after a bowel movement and rectal pain. The patient had apparent external hemorrhoids. The patient denied diarrhea.

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.

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.

Rash all over her body her back and front; some pain in her stomach; This is a spontaneous report from a contactable consumer (patient's husband). A 77-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 Vaccine; lot number: EL9269; expiration date: unknown) at 77-year-old vaccination age via an unspecified route of administration on 07Feb2021 at a single dose for covid-19 immunisation. Medical history included prediabetes and slight blood pressure or something (blood pressure abnormal). Concomitant medication included hydrochlorothiazide and unspecified medication (reported as she takes all kind of medications), all on an unspecified dates and indication. The patient received her first dose of bnt162b2 (BNT162B2; unknown lot number and expiration date) at unknown vaccination age via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The reporter inquired for his wife because her body now. They had the second shot on 07Feb2021 (Sunday) and he wonder how many days it takes after the shot to have side effects. She has rash all over her body her back and front on Feb2021 so he wonders if the shot could cause that. They had the vaccine given to them in a hospital. The reporter mentioned that she just a blood test (unknown results) on the 8th Monday (08Feb2021). She went to the ER (emergency room) in the same hospital. They did the whole work/lab work (unknown results) because she had some pain in her stomach on Feb2021. The outcome of the events was unknown.

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.

Within 30-minutes of vaccination, the patient reported feeling nauseous. The patient was reportedly hypertensive. No EMS report was filed. The patient did proceed to Emergency Department for follow-up. In the ED, the patient was hypertensive (153/69) and stated they continued to be nauseous. The physician administered 4mg IV Odansetron and 1L IV saline. Labs were unremarkable. The patient reported feeling improved after treatment and was discharged with a diagnosis of Side effect of vaccination.

Woke up to go to bathroom about 3:50 am and couldn't get out of bed. I was completely off balance. I tried to walk and couldn't. Sat down again but had to do so I hung on to the bed, walls, and doors to steady myself to get to bathroom. Had a little diarrhea. Managed to take 2 Tylenol and drank lots of water. I held on to everything again and got back to bed but sat up instead of laying down. I still had diarrhea so I held on to every thing again and took one Anti-Diarrhea pill. Went back to bed sitting up and tried to sleep. Got up around 8 am and felt better but still a little woozy.

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.

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.

"Pt presented to Clinic for her vaccine. Post vaccine, pt was feeling faint/weak and was pale. Pt sts feeling short of breath prior to arrival. Pt has hx of lung cancer. Pt was drained last at home on 3/14 per pt husband. EMS performed 12 lead and checked vitals. Pt color improved upon lying on stretcher for a few minutes. Pt's pulmonologist was contacted to see if they want her to go to her appointment scheduled at 1330 or to be transported to ED. Pt. was then transported via EMS to ED." Pt was inpt from 3/18/21 - 3/21/21 with diagnosis of E. Coli bacteremia, recurrent left pleural effusion with drain in place, resolved hypoxia on oxygen, follicular non Hodgkin's lymphoma, pancytopenia, poor appetite, insomnia. Patient was started on cefepime and then Rocephin per Infectious Disease team but she continued to the duration of this admission until ultimately transitioning her to oral antibiotics with Cipro twice daily to complete 7 day course from 03/19; this prescription was sent to her pharmacy upon discharge. Discharged home with hospice services (per pt /family preference) for comfort care

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.

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.

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

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.

had diarrhea last night; had cramping most of the night; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiry was not reported) via an unspecified route of administration in Arm Left on 02Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 02Feb2021, the patient experienced diarrhea last night and cramping most of the night. Additional Context included, caller states that she got the COVID vaccination. Caller states that she did not know what she was getting until after she got the injection and this paper they gave her. Caller states that her daughter had called and said that there was clinic, and the lady from the clinic called and scheduled an appointment for the caller. Caller had no other vaccines on the same day as the COVID vaccine. The outcome of the event was unknown. Follow-up nformation on the lot/batch number has been requested.

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

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.

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.

Bleeding; Blood in her stools; Volumes of regular stool/went to the bathroom 20 times; Did not have blood on the toilet paper, no rectal bleeding, and had volumes of regular stool/there may be something in the vaccine that could help her Irritable Bowel Syndrome; Aching arm; This is a spontaneous report. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9267; Expiration date was not reported) on the left arm on 28Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the Health Department. Medical history included ongoing irritable bowel syndrome for over 50 years; high level of hormones; was losing hair; and had rectal bleeding from Jan2021 to an unspecified date. Concomitant medication included ongoing spironolactone from Jan2021. On 01Mar2021, the patient did not have blood on the toilet paper, no rectal bleeding, and had volumes of regular stool, and mentioned that there may be something in the vaccine that helped her irritable bowel syndrome; and had aching arm. On 02Mar2021, the patient was bleeding; had blood in her stools; and had volumes of regular stool, and went to the bathroom 20 times. The patient did not receive any treatment for the reported events. The outcome of the events was unknown. The patient had received the second dose of vaccination on 28Mar2021.

she and they thought she was having a heart attack; she must have passed out because she didn't remember all the tests; she got a sharp pain underneath her left rib cage/pain was number10/still had pain off and on, periodically; broke out in sweat, real bad, number 10, she broke out in a clammy sweat; hard to breath, she got a sharp pain underneath her left rib cage; the muscle that goes around her heart, it was having like a charley horse; heart rate, She says 102, 103, it went up to 200 in the ambulance.; chest pain; Nausea; hard to breath, she got a sharp pain underneath her left rib cage; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as single dose for COVID-19 immunization. Medical history included ongoing atrial fibrillation for a about 6 years , ongoing anemic for the last 20 years, glaucoma from 1998, had both eyes operated on and in 2016 she was operated on again, cataract had this 4 years ago in she says, in 1918, 1919, she clarifies 2018, Cardiac pacemaker insertion which pacemaker that controls her heart so the pulse does not drop below 65. She says that pacemaker was implanted, she thinks, 2014 maybe, blood pressure, arthritis throughout her body and had 30 operations, body doesn't absorb what she eats, anxiety, asthma, muscle spasms; she reported she has had a lot of surgeries, both of her ankles have had triple fusions, these were in 2005, 2010, 2014, 2018, both her ankles were fused, she had 5 surgeries on her feet; she has had both of her knees replaced because of arthritis, 2012 and 2015 she believes, had numerous other surgeries and she doesn't want to go through all of them, a right shoulder reverse rotator cuff repair, she had a rotator cuff put in, she doesn't have a rotator cuff, this happened in 2019, her left shoulder, because of an automobile accident, rotator cuff was so damaged that they couldn't repair it, she has minimum use of her left arm and has had operations on her left shoulder in 2005; had a pacemaker put in about 6 years ago, the next morning they kept her overnight, they came in, they took an Xray, she had to go back 2 days later because the lead had come of the heart, they had to go back in an reattach the lead to the heart; 2 years ago her pacemaker was going all over her chest, the doctor did not believe her and it landed under her armpit, it was the size of an orange, the doctor thought it was a lump, she went to the hospital, her pacemaker started falling apart, they took it out and put a new one in, it was about 4 years ago; a lump in her breast, she has been put under 30 times, they were all necessary, nothing for glamorizing; had surgeries in her left arm and some fingers than were numb. There was no prior vaccinations within 4 weeks, no events prior vaccinations and no family history. Ongoing concomitant medication included baclofen taken for muscle spasms for about 2 years, calcium for arthritis and her bones degenerate for 30 years, ergocalciferol (CALCIFEROL VIT D) taken for gets anemic real easy for 20 years, duloxetine taken for anxiety, taking this about 3 years ago; ferrous sulfate taken for anemic real easy for about 20 years; folic acid taken to rebuild cells taking this she thinks in 2015, furosemide taken for a diuretic to get rid of fluid for 2 years, metoprolol tartrate taken for atrial fibrillation, and blood pressure, taking this since she had her pacemaker put in; montelukast for asthma for 20 years; hydrocodone bitartrate, paracetamol (NORCO) taken for arthritis for 20 years, and warfarin taken for blood thinner/thin the blood out so she doesn't get blood clots; and adults vitamins for bone supplement and metabolism for 20 years as her body doesn't absorb what she eats. She says she takes a lot of medications and when she does blood bloodwork she was low so they make her take them. The patient previously took rivaroxaban (XARELTO). On 06Feb2021, the patient experienced she thought she was having a heart attack. The patient reported that she had to call an ambulance at 11:30 at night, she thought she had a massive heart attack. She had chest pain, nausea, it was hard to breath, she got a sharp pain underneath her left rib cage. She stated that when the ambulance got here they thought she was having a heart attack, they did nitroglycerin, when they got to the house, when in the ambulance on the way to the hospital they did another pill of nitroglycerin when they got to the hospital. The pain was a number 10. She stated she broke out in sweat, once they got her all hooked up they got to the hospital 6 miles away to the hospital. She was there for 2 full days, they did Xrays, dye in her, checked her hears, and did bloodwork. When she had chest pain, she reported they gave the morphine, it lasted about 6 hours; she still had problems breathing, they took her, she must have passed out because she didn't remember all the tests, she was in and out of it, the severe pain stopped after 6 hours, still had pain off and on, periodically. When she got pain in the ambulance then the nausea went away. After the hospital nitro and another shot for the pain, the nausea stopped. After the hospital after this they gave morphine and the pain subsided a little but didn't totally go away until 6 o'clock in the evening, she still had problems breathing because every time she breathed she got pain under her left rib cage. She says the sweat was at home, real bad, number 10, she broke out in a clammy sweat, on the 6th when she was having pain. She says that after the hospital, a couple days after that, she saw her cardiologists, he told her what happened, it was related to vaccine, it was the muscle that goes around her heart, it was having like a charley horse, he says it felt like you're having a heart attack, her tests said her heart was good. She talks about her blood pressure and heart rate, and says 102, 103, it went up to 200 in the ambulance. She says they thought it was a heart attack, her blood pressure was usually low blood pressure and all the symptoms she was having was because of her muscle having a charley horse that felt like it was coming from the heart, if they had contacted him, he said she would have just needed a massive amount of anti-inflammatory and it would have stopped the pain. The events required an emergency room visit. She wanted to know if anybody else has been hospitalized for massive heart attacks and says that's what she was having. The patient had her second shot on 22Feb2021. Outcome of event nausea was recovered on an unspecified date; and outcome of the rest of events was unknown.

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

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.

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.

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

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.

abdominal discomfort; 3 itchy bumps also appeared in the left breast area; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Feb2021 08:30 (Lot Number: EL9265) at single dose for COVID-19 immunization. Medical history included hypertension and irritable bowel syndrome (IBS), Shellfish allergy. Patient didn't have COVID prior vaccination. Concomitant medications included metoprolol succinate ER 25mg taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported. No other vaccines were administered in four weeks. After the shot on 01Feb2021, there was abdominal discomfort within 15 minutes. 3 itchy bumps also appeared in the left breast area. No treatment was received for the events. The outcome of the events was not recovered. COVID was not tested post vaccination.

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.

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.

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.

Severe diarrhea after the vaccine on day 1 and day 2 following administration. Felt better on day 3.; This is a spontaneous report from a contactable consumer (other-HCP). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) intramuscularly in right arm on 12Feb2021 12:45 as 2nd single dose and had previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) intramuscularly in right arm on 21Jan2021 10:00 as 1st single dose (at the age of 77-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history included AFib. The concomitant medication included rivaroxaban (XARELTO). The vaccination facility type was reported as Other. Patient did not receive any other vaccine in four weeks. Patient did not receive prior COVID-19 vaccination. Patient was not tested for COVID-19 post vaccination. On 13Feb2021, patient experienced severe diarrhea after the vaccine on day 1 and day 2 following administration and felt better on day 3. Patient was not given any treatment for the adverse event. The outcome of the event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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

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.

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.

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.

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.

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.

major bleed; GI bleed; 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) via an unspecified route of administration, administered in Arm Left on 25Feb2021 (at the age of 77-year-old) (Lot Number: EN6200) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Medical history included first time she experienced bleeding was in 2013 because of aspirin. Stated that she decided it was a good idea to take baby aspirin so she took it on her own. She was told don't ever take aspirin ever again and she didn't have any problem until Nov2020. That was the first incident, in 2013, that told her she should not take blood thinner. They took her off the blood thinner in Nov2020. She had been taking aspirin. She lost half her blood; she lost it two settings. She sat down to take a bowel movement and was told she lost half of her blood. Not sure when she started Aspirin but she stopped it in 2013. It was mentioned that she could take aspirin. She was on a low dose of Eliquis for atrial fibrillation for prevention of a blood clots or heart attack. she had bleeding in the last year. The one that was the most was back in Nov2020; it was more pronounced. Mentioned that she went in on 12Nov2020 for the bleeding and then had to go back in because her legs were swelling. She stopped taking Eliquis in Nov2020 and from then until Apr2021 she had no bleeding. It was several years ago when she was diagnosed. She was riding her bike in the neighborhood, and felt too tired so she stopped at the doctor and went in and told them she felt weird, they couldn't get her BP and took her to the hospital and her heart rate was sky high like 250. They said she might had to have electric. She didn't have any pain but states she was psychologically freaked out by everyone running around. Mentioned that, she was first placed on dronedarone (MULTAQ) 400mg twice daily to treat her atrial fibrillation; she can't remember the year. After taking it as prescribed for some time she got atrial fibrillation again. She was told by the doctor it had lost its efficacy. Concomitant medications included Fenofibrate taken for blood cholesterol, Metoprolol succinate taken for blood pressure, Vitamins NOS, Ferrous Sulfate taken for anemia, Vitamin D3 all are ongoing. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EL3246) on 06Feb2021 in arm left for covid-19 immunization. It was reported that, On 25Feb2021 she received her second dose of the Pfizer-BioNtech Covid-19 vaccine, on 19Apr2021 she had a major bleed and GI bleed (Hospitalization) on 19Apr2021. The patient was hospitalized for major bleed and GI bleed from 19Apr2021 to 21Apr2021. Outcome of the events was unknown. No further information 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.

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.

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.

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: EL9269), via intramuscular route, administered in Arm Left on 09Feb2021 10:30 as 1ST DOSE, SINGLE for COVID-19 immunization. The patient was 77-years-old at the time of vaccination. Time the vaccination was given was 10:30. The patient medical history included diabetes from 2012 to an unknown date, high blood pressure from 2012 to an unknown date and thyroid problems. Family medical history: All of family have high blood pressure and thyroid problems, thyroid surgery on 2012. No concomitant medications prior to Vaccinations (within 4 weeks). On 11Feb2021, Patient reported that she felt that there was lots of gas in her stomach after she had the 1st dose - She described it that there are lots of gases in her stomach and once she goes to the bathroom it suddenly disappears. She never had gas like this. The gas fell down in her stomach all of a sudden. If she has gas, she takes pills or something. This is like more progressive. She doesn't hardly have any irritation in bottom of stomach. She never had it. She would like to know if her stomach problems are a side effect from the vaccine. No relevant test. Events were assessed as non-serious. The outcome of event was not recovered. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

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.

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.

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

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.

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.

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.

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.

little nausea; This is a spontaneous report from a contactable Other HCP and contactable consumer (patient). A 77-year-old female reported that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not provided), via an unspecified route of administration on 04Feb2021 (at the age of 77 years), as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experience little nausea. The outcome of the event was unknown. No additional information/details provided. Information on the lot/ batch number has been requested. Follow-up attempts completed. No further information expected

Cramping; Diarrhea; This is a spontaneous report from a contactable nurse (the patient). A 77-year-old, non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249) via an unspecified route on left arm on 11Feb2021 at 14:00 (at age of 77-year-old at vaccination) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had medical history of hypertensive. Concomitant medications included hydrochlorothiazide, triamterene (DYAZIDE); biotin; glucosamine; metoprolol succinate (TOPROL XL); fish oil for unknown indications within 2 weeks prior to the COVID vaccine. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient previously took scopolamine [hyoscine butylbromide] and demerol and experienced drug allergy. On 18Feb2021 at 12:15 PM, the patient experienced cramping and diarrhea starting a week after first shot and lasting 2 weeks after second shot. Doctor or other healthcare professional office/clinic visit for the events. The events were treated with Imodium and Bentyl. The outcome of the events of cramping and diarrhea was recovered on an unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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.

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

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.

Elevated blood pressure; swelling in mouth/lips; Nausea; Sensitivity to sound; Severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils); This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0140), via an unspecified route of administration in the left arm on 20Jan2021 at 10:00 (at the age of 77-years-old), as a single dose for COVID-19 immunisation. Medical history included spinal stenosis, degenerative disc disease, arthritis, sciatica, high blood pressure, diabetes, high cholesterol, pollen allergy, dust allergy, ragweed allergy, carageenan allergy and fruit allergy (tomatoes). Concomitant medications included morphine sulfate (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and metoprolol succinate (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously took simvastatin on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 22:00, the patient experienced swelling in mouth/lips, severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils), nausea, sensitivity to sound and elevated blood pressure. It was unknown if therapeutic measures were taken as a result of the reported 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 swelling in mouth/lips, severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils), nausea, sensitivity to sound and elevated blood pressure were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

"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

After vaccine administration, pt experienced severe diarrhea with incontinence.; After vaccine administration, pt experienced severe diarrhea with incontinence.; This is a spontaneous report from a non-contactable pharmacist. A 78-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EK5730, intramuscular from 16Dec2020 to 16Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. After vaccine administration on 16Dec2020, The patient experienced severe diarrhea with incontinence. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.

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

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.

1037am Reports Difficulty Swallowing 1043 Benadryl 25mg and Oxygen mask 1058am Patient reported resolution of symptoms. Patient escorted and ER precautions given.

Slight nausea; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3248), via an unspecified route of administration on the left arm, on 13Jan2021 at 10:15, at a single dose for Covid-19 immunization. Medical history included vertebral artery occlusion. The patient did not receive other vaccines in four weeks. Concomitant medications included metoprolol, amlodipine, tramadol, and hydrochlorothiazide. The patient previously took oxycodone hydrochloride;paracetamol (PERCOCET), acetylsalicylic acid;oxycodone hydrochloride (PERCODAN) and hydrocodone and experienced allergies. On 13Jan2021, at 11:30, the patient experienced slight nausea. The patient did not receive any treatment for the event. Outcome of the event was not recovered.

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

Persistent acid reflux (unusual for me)( didn't respond to TUMS) followed by severe but short term vomiting lasting about 5+ minutes. I feel fine now (30 minutes later) Last thing I ate before vaccination was 2 pieces of toast with butter and a banana for breakfast eight hours earlier than the vomiting..

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.

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.

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.

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.

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.

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.

Nausea most of the day; 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; Solution for injection, unknown lot number and expiration), via an unspecified route of administration in left arm on 11Jan2021 at 18:45 at a single dose for COVID-19 immunization in a hospital. Medical history included hypertension and stress. The patient has no known allergies. Concomitant medications included atorvastatin, ezetimibe, amlodipine, and irbesartan. On 17Jan2021 at 13:00, the patient experienced nausea most of the day. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not received treatment for the event. The patient recovered from nausea in Jan2021. Information on the batch/lot number has been requested.

3rd day became very dizzy, dry heaves. Dizziness continues for 2 weeks now, gradually improving in intensity and frequency.

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.

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

At about 2:00 a.m. on Feb. 6th I was awakened by nausea and vertigo that lasted until about 10:00 that morning. Sat. afternoon I was feeling much better.

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.

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.

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.

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

Bell's Palsy diagnose 2/5/2021 and treated with Prednisone and antiviral. Has history of Bell's palsy in the past. She started with right sided facial droop and was choking with swallowing.

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.

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

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.

RECEIVED PFIZER COVID19 VACCINE ON 02/14/21 PRESENTED TO THE ED ON 02/19/21 WITH ABDOMINAL PAIN (CRAMP/ACHY PAIN) IN RIGHT LOWER QUADRANT X5 DAYS. DIAGNOSED WITH ACUTE ABDOMINAL PAIN IN THE RIGHT LOWER QUADRANT AND NON-INTRACTABLE VOMITING WITH NAUSEA. DISCHARGED FROM ED AND INSTRUCTED TO FOLLOW UP WITH PCP.

1st Vaccine 2/14/21; same day onset RLQ ABD pain with nausea and vomiting; seen at ED on 2/19/21 for ongoing symptoms; d/c'd home from ED same day to follow up with primary care as outpatient. Dx in ED: 1. Acute abdominal pain in right lower quadrant 2. Non-intractable vomiting with nausea, unspecified vomiting type

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

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).

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

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.

she was "Just not feeling myself - nothing I can even describe in detail, just vaguely not myself; Did not want supper; This is a spontaneous report received from a non-contactable consumer (patient herself). A 78-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: Not available), via an unspecified route of administration on 23Jan2021 to 23Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient reported that on Monday (2 days post-vaccine on 25Jan2021) she was "Just not feeling myself - nothing, she can even describe in detail, just vaguely not myself. Did not want supper so had scrambled eggs and toast and went to bed early. Woke up feeling fine. She hardly ever felt other than fine and she could not think of anything other than the vaccine on Saturday that was unusual. On Sunday, she felt fine and today she feel fine". Treatment was not received for the events. The outcome of the events was recovered on Jan2021. No follow-up attempts are possible; Information about lot/ batch number cannot be obtained.

Extreme pain and burning sensation in abdomen (Day 4-6), extreme pain (bone/joints/muscles) in left arm (Day 6-8)

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

RECEIVED FIRST DOSE OF PFIZER COVID 19 VACCINE ON 02/26/21. WENT TO ER ON 02/27/21 COMPLAINING OF HEMATEMESIS AND BLOCK COLORED STOOL. ANTICOAGULATED ON ASPIRIN AND PLAVIX. DIAGNOSED WITH UPPER GI BLEED AND ADMITTED TO HOSPITAL ON 02/27/21.

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.

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

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 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.

2 days after getting 2nd dose of vaccine I became dizzy and queasy and my breathing changed. I spoke with pulmonologist on 3/1/21 and he advised me to start a 5 day regimen of 40 mg. prednisone. I am on day 3 and breathing has been better, not back to normal.

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.

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.

Mild diarrhea, loss of appetite, back ache, and hip ache. All were mild and lasted two to six days. This happened only after shot number two.

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.

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.

Slightly Nauseous; Slightly dizzy; Thinks it activated her reflux; clogged up; This is a spontaneous report receive from a contactable consumer (patient herself). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number EL9626) via an unspecified route of administration on the left arm on 28Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included ongoing Reflux. Concomitant medication included esomeprazole sodium (NEXIUM). Patient previously took BNT162B2 on 07Jan2021. On 28Jan2021 20:00 the patient experienced slightly nauseous, slightly dizzy, thinks it activated her reflux and clogged up. Seriousness was reported as non-serious. Outcome of events was recovering. No follow-up attempts are possible. No further information was provided.

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.

episode of diarrhea; This is a spontaneous report from a contactable consumer. A 78-year-old non-pregnant female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in arm left on an unspecified date (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, gastrooesophageal reflux disease (GERDS) and hypertension from an unknown date and unknown if ongoing. The patient had other concomitant medications received within 2 weeks of vaccination, reported as 'many'. The second night after vaccination (unspecified date), the patient suddenly had an episode of diarrhea, could not get to the toilet in time. There was no treatment received for the adverse event. The outcome of the event was recovered on an unspecified date.

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.

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.

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.

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.

metallic taste in mouth and nausea. Was asked to wait an extra 15 minutes and give pretzels and water. Felt a little better and wnt home. Nausea continued for 5days u with discomfort at the pit of my stomach, then I started with multiple bowel movements for the past 3 days.

my heart started pounding, rate was 130-140; BP went to about 180/110; nauseated; This is a spontaneous report received from a contactable consumer reported (patient herself). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6205), via an unspecified route of administration on 28Feb2021 11:30 in left arm at single dose for covid-19 immunization. Medical history included IBS (irritable bowel syndrome), migraine, and allergies: codeine, mushrooms, shrimp. Pregnant at the time of vaccination was no. Concomitant medication within 2 weeks of vaccination included atenolol; ergocalciferol (CALCIFEROL VIT D); esomeprazole magnesium (NEXIUM 24HR); methylcellulose (CITRUCEL); paracetamol (TYLENOL); atorvastatin (LIPITOR). The patient previously took the first dose of bnt162b2 (lot number: EL9264) on 07Feb2021 at 09:00 AM in right arm for covid-19 immunization. About ten hours after injection (28Feb2021 21:30), her started pounding, rate was 130-140, BP (blood pressure) went to about 180/110 and she became nauseated. This happened as she was sitting quietly watching TV. After about 15 minutes she called 911 and was taken to hospital. All events were reported as serious and resulted in emergency room/department or urgent care, hospitalization on 28Feb2021. The patient underwent lab tests and procedures which included nasal swab: negative on 01Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment for events included Telemetry, ondansetron hydrochloride (ZOFRAN), prochlorperazine edisylate (COMPAZINE). Outcome of events were recovered in 2021.

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.

extreme vertigo, vomiting, diarrhea - lasted about an hour. This was repeated the following night, about 3:00 am. Since then I have had several more vertigo incidents with vomiting and diarrhea, and I have some dizziness and nausea on a regular basis

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.

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.

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.

Swelling on her right ear; Symptoms of the flu/side effects like the flu; Diarrhea/bad diarrhea; Urinating like crazy/had to urinate non-stop; Sick; Swelling on her right eyelid; Pain down her neck; Everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side; 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, Solution for injection, Lot number: EL1283, Expiry date: unknown) via an unspecified route of administration, administered in Right Arm on 19Jan2021 (at the age of 78-years-old) at a single dose for covid-19 immunisation. Medical history included mastectomy (she had a mastectomy before, so she has no lymph nodes, she doesn't let them touch her left arm. She says this was done 26 years ago when she was 52), arthritis (she has bad arthritis in her back), Blood pressure high (she takes a high blood pressure medication), High cholesterol (she takes a high cholesterol medication) and eye surgeries (she has had all kinds of eye surgeries before this). The patient's concomitant medications were not reported. The patient experienced swelling on her right ear, symptoms of the flu/side effects like the flu, diarrhea/bad diarrhea, urinating like crazy/had to urinate non-stop, sick, swelling on her right eyelid, pain down her neck, everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side on an unspecified date in 2021. The patient stated that she had a lot of side effects and she talked to her doctor who said to go ahead and get the second dose. She says she had no fever, but had all the rest of the side effects, such as swelling of her neck, ear, and eye, which all went away fast. She says she was sick almost 4 days, and her doctor said side effects shouldn't last that long, so she called to get advice about whether to get second shot or not. She says her appointment for her second shot is the 09Feb2021, she would like to know if it is safe for her to get. She says her side effects started in the evening, the swelling of her right ear didn't last, it went away. She says during the night she woke up and had to urinate non-stop that started that night a day later. She says that lasted the next day, then the day after, until Saturday she felt better. She says she had all side effects like the flu, then later bad diarrhea too. She says she finally took something for diarrhea (no further information provided about this) and took Tylenol. she doesn't see the expiration on that bottle, she thinks it is good for 2021. She says that she doesn't see too good. She clarifies that they Tylenol she had took before, with no issues, and her not seeing too good had nothing do with the vaccine, she has had all kinds of eye surgeries before this. She says her right ear was swollen, everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side. She says that the pain started about a day later Pfizer COVID-19 vaccine. Caller says that she called her doctor today, that was the first time she did that, she was trying to wait and see, and her doctor said normally side effects don't last that long, so he has her worried. She says if she does not take the vaccine she will not be protected, but if she does, she may have worse side effects. Therapeutic measures were taken as a result of diarrhea/bad diarrhea. The patient recovered from the event swelling on her right ear on an unspecified date in 2021, outcome of the event Urinating like crazy/had to urinate non-stop was recovering, while outcome of other events was unknown.

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.

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.

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.

rise in Cr; Developed decreased PO intake; mild acute kidney injury; pancytopenia; lymphopenia; thrombocytopenia; This is a spontaneous report from a contactable Physician. A 78-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 10Mar2021, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient had unspecified concomitant medications. The patient had the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 Immunisation. On 13Mar2021, the patient developed decreased PO intake, then mild acute kidney injury with rise in Cr and pancytopenia/lymphopenia/thrombocy topenia. The events caused hospitalization. Treatment for the events were IV fluids, Hematology consult. The outcome of the events was recovered. The patient had negative covid swab test on 12Mar2021.; Sender's Comments: Based on the narrative information provided, a causal association between the reported events and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

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.

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.

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.

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.

**Please note that the same adverse reaction (diarrhea) occurred after each of my two Covid -19 vaccinations. See separate VAERS form for the second incidence.** I had my first Covid-19 vaccination shot on 1/11/2021. About five days later (1/16/2021), I awoke with an episode of diarrhea. This continued for about 10 days, until 1/25/21. On most days, these episodes were first thing in the morning only (on waking), but some days had more episodes, with some in the middle of the night. I had loss of appetite but no vomiting or fever and only slight weight loss. [I had started the antibiotic Sulfamethoxazole ? TMP SS in December 2020 and wondered if this might be a cause, but I checked with my urologist and we agreed that I had likely taken it for too long for it to be an issue.] **Please note that diarrhea started again on 2/2/2021, the morning after my second Covid shot. See separate VAERS form for this incidence.**

**Please note that this form continues the story of diarrhea after my first Covid shot (1/11/2021). See earlier VAERS form for the first incidence.** I had my second Covid-19 shot on 2/1/2021. The following morning, I awoke with diarrhea, and this continued for nearly three months, with a brief gap from 2/11 to 2/14. At first, my stool was lumpy, with mucus, but it gradually turned quite watery. It was also clear by eye that I was having trouble digesting higher fiber foods (salads, fruit & vegetable skins, et al.), so I worked to keep to a lower fiber, bland diet. Episodes of diarrhea varied with the day, but they usually occurred first thing in the morning, with some additional episodes during the day or in the middle of the night. By the end of this period, I had lost about eight pounds.

Pt admitted on 4/5/2021 c/o roughly 4 weeks of just general dyspepsia and feeling like she had acid reflux. She reports that then progressed to some nausea and then vomiting and then some generalized right upper quadrant midepigastric abdominal pain. She also noticed that her skin was becoming yellow. She reports no changes in any of her medications recently she had her second COVID-19 vaccination on 2/14 and blood work on 2/ 8 consisting of liver enzymes/CMP was normal. she arrived severely jaundiced with severe transaminitis, hyperbilirubinemia and acute renal failure. ERCP revealed no gross obstruction and free flowing bile and sphincterotomy was done with no improvement in her blood work. she remains hospitalized and is being transferred for HLOC due to worsening condition REVIEW OF SYSTEMS:

About 5 days after injection, I had a bout of nausea and diarrhea and noticed severe itching. The stomach issues resolved after a couple of days, but the severe itching continued and is especially bad wherever my clothing comes in contact with my skin. Over the next several weeks, I tried hydrocortisone cream, Benadryl gel, Benadryl tablets, Calamine lotion, corn starch, menthol itch cream, but nothing has helped for very long. I don't have much of a rash...just a bit of raised redness when the itching is particularly bad. I have been miserable with it. I visited my neurologist for Botox injections and asked her about it and she said she thinks I'm having a histamine reaction to the Covid vaccine. The severity of the itching is getting slightly better, but it's now been almost 6 weeks of unrelenting itching. I'm not taking Benadryl 3 times a day.

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.

After 5 minutes of receiving vaccine, patient became nauseous. Once home, she complained of dizziness. Around 4am, patient was awakened with strong heart palpitations. She noticed ankle and foot swelling after about a day. She also noticed a rash on the vaccine arm, neck and under chin. She experienced severe nausea and vomiting over the next 3 days and could not eat food. She did not seek medical attention and chose to stay in bed to recover. As of today, the patient says she is almost recovered from these events.

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.

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.

Adverse events: unstable, too dizzy to walk, through-up, double vision. Treatment: wait for the symptoms to pass.. The symptoms have lessened but are still with me.

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.

I had an unsettling waking event happen to me yesterday morning, so I didn?t feel like I could gather myself to be at an appointment after the event. I was very disoriented upon waking. I could not gather my thoughts and memories. Things like: I knew I was in a city , but didn?t know where the city was in the world; and other things like that. It was as though I had stepped out of my life and didn?t remember enough to step back in. It only lasted maybe 5 min, but was completly disconcerting & disarming. I?ve never had a similar event. And it came after another disarming 10 min bout of dizziness / sense of off-balancedness and a very slight nausea the night before. It too, was arresting because I had had no alcohol to drink for months. I felt continually better during the early morning and didn?t think about it much during the rest of the day.

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.

Diarrhea; several episodes of heart arrhythmia on two different days starting 10 days after second COVID-19 vaccine injection. Although I am predisposed to heart arrhythmia having been diagnosed with super ventricular tachycardia in late teen years, then atrial fibrillation starting at age 60, I was getting an episode of a-fib only once every 3-4 months following an ablation procedure. This was different as I had several episodes in a day on two different days. They subsided only following the taking of propafenone.

Patient experienced an arthritis flare after the 1st dose, and this became much more intense after the 2nd dose. She had increased weakness, abdominal pain, loss of appetite (not eating/drinking much), falls, and failure to thrive x3 weeks after the second dose which all ultimately got her admitted to the hospital (4/6/21). Upon admission, her blood counts were found to be dangerously low.

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

cataract; nausea; Diarrhea; nervous; This is a spontaneous report from a Pfizer sponsored program. A contactable 78-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on left arm on 04Feb2021 at single dose for COVID-19 immunization. The medical history of the patient included high blood pressure (Caller mentioned this was diagnosed in her late 50s or early 60s, and she was 78 now). She also had history of irritable bowel disease and hiatal hernia which was diagnosed years ago. She said that she did not had any other recent vaccinations or started any new medications. However she takes high blood pressure pills and stomach medicines and a medication for her bowels. It was reported that she had cataract in Feb2021 for which she underwent cataract surgery on 18Feb2021 taking eye drops- Prolensa every morning for 1 and half week. On an unknown date in Feb2021, she was nauseated and had diarrhea. She says she got the shot 04Feb2021 then a few days later she had diarrhea. She mentioned that she was scheduled to get the second shot today i.e. 26Feb2021 Friday, and her son saw on tv some people can get diarrhea, which she did not know before. She said that she had not gotten a temperature, and her BP was fine. She mentioned that she had irritable bowel disease anyway, and usually when she has that it clears in a week. She says that she would like to know if it is safe for her to get the second shot. On an unknown date in Feb2021, she experienced nervousness and it will have repercussions. She said that her son said there was some program on TV that listed all those things, some that were not in the paperwork she got. She had been nauseated or had diarrhea, and she called before, and some people get diarrhea, and she was supposed to check and see if she should get second shot. The outcome of all the events was unknown. Caller mentioned that she called her provider, but they were not going to get back to her in an hour and a half before she would go to get the second dose. She says she got the first dose of the vaccine at (Pharmacy) and says that she thought her diarrhea was better and then it came back the day before yesterday. She mentioned that her vaccine card was handwritten, and she could not read the writing on it. She says it mentioned (Clinic site) and that the handwriting was horrible on the card, and she could not tell if the LOT was E129EG. She says NDC/EXP were not provided on the card. The caller said that she has either got to get the shot or cancel this one, but if she cancels this one she does not know when she would be able to get second since the appointments are all booked up in (State). No follow-up attempts are possible; information about lot/batch number cannot be obtained.

back was so stiff; extremely difficult to stand; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; so dizzy I could not stand up; no appetite; brain fog; I shuffle very short distances and very slowly trying to avoid a fall.; toes and bottoms of feet were also totally numb; This is a spontaneous report from a contactable other health professional (patient). A 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration, in the right arm, on 15Mar2021 08:45 (lot number: EN 6207), at the age of 78, at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was at the hospital. Patient medical history was not reported. Concomitant medications included losartan, hydrochlorothiazid and fexofenadine hydrochloride (ALLEGRA) for unspecified indications. The patient previously received first dose of bnt162b2 via unspecified route of administration, in the right arm, on 23Feb2021 14:30 (02:30 pm) (lot number: EN 5318) for COVID-19 immunization. On 15Mar2021 11:15, exactly 2 and a half hours after receiving the second dose of vaccine, patient tried to stand up but experienced back was so stiff; it was extremely difficult to stand. When patient was in a standing position, an electric bolt of pain shot in her left groin and down the right of her left thigh and into her left knee on down inside the left calf, left ankle and left toe; all on 15Mar2021 11:15. The pain has been constant and the most horrible pain she have ever suffered, as reported. It was reported that patient have never had this type of episode before in her life, which causes her to believe it has been a side effect of the 2nd dose of the vaccine. The pain continues to this day, at the time of reporting. Patient also experienced being so dizzy, she could not stand up; no appetite and brain fog on 15Mar2021 11:15. Before the shot, patient reported she can walk 50 blocks daily for the past 10 years. After 15Mar2021 (on unspecified date in Mar2021) she shuffles very short distances and very slowly trying to avoid a fall. Her toes and bottoms of feet were also totally numb when she wakes up each morning, since unspecified date in Mar2021. Treatment was received for the events (unspecified medications) on 28Apr2021 and physical therapy. Patient went off the medications the doctors gave her on 28Apr2021, choosing to tolerate the pain. The pain to this day, somewhat diminished. The events resulted to a Doctor or other healthcare professional office/clinic visit. Events were assessed as serious, disability. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the events, musculoskeletal pain, dyssastia, groin pain, pain in extremity, arthralgia, postural dizziness, hypoesthesia, feeling abnormal cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate.

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.

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.

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.

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.

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.

She also is diabetic and has high eye pressure.; The pain is going to her neck and does not let her raise her arm. She also mentions that she also have a sharp pain in her belly and she did not have it before.; Feeling that her shoulder is killing her.; The pain is going to her neck and does not let her raise her arm. She also mentions that she also have a sharp pain in her belly and she did not have it before.; she also have a sharp pain in her belly; 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 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 30Apr2021 as a single dose for covid-19 immunization. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) via unspecified route on an unspecified date. The patient's medical history included diabetes. The patient's concomitant medications were not reported as single dose. It was reported that the patient felt that her shoulder was killing her. The patient stated that the pain was up to her neck and does not let her raise her arm. The patient also stated that she also had a sharp pain in her belly which did not had it ever before all on 19May2021. The patient also stated that she was also a diabetic and has high eye pressure. Patient called her doctor this morning and could not find him so she she left a message. Patient did not want to go to the ER and she wanted to know why she was having these adverse reactions after 20 days of taking the vaccine. The patient was explained about the reports of muscle pain and pain in the injection site, the possible duration and being more intense after the second dose. The patient was recommended to consult her physician to determine the cause of her pain. Therapeutic measures were not taken as result of AE. The outcome of the events was unknown. Information on lot number/batch number was requested.

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.

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.

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.

neck spasms; diarrhea; the urge to go to the bathroom all day long; a bloating abdomen with a lot of gas; a bloating abdomen with a lot of gas; feeling severe muscle pain in the stomach; This is a spontaneous report from a contactable consumer. This 78-year-old female consumer (patient) reported. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 (at the age of 78-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient called to report her symptoms after the administration of the second dose of the Pfizer's COVID-19 vaccine. On 06Feb2021, the patient started having neck spasms, diarrhoea, and the urge to go to the bathroom all day long, also a bloating abdomen with a lot of gas, feeling severe muscle pain in the stomach. She stated her symptoms were not putting her on risk based on the information that she received about the vaccine when it was administered to her. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

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.

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.

Individual contacted 06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she experienced left arm pain 3 days following injection, pain persists in left arm and is constant, unable to reach above shoulder level, unable to lay on left side, complains of weakness in left arm, unable to sleep, complains of weight loss and "acid reflux" since receiving vaccine. Denies any fever, rash, cough, cold symptoms s/p vaccine. She states she has treated with her PCP and Occupational Therapy for her complaints with no relief, she relates PC and OT have diagnosed her with "bursitis".

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.

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.

Colon cancer metastatic; Lung disorder; Kidney stones; Kidney cancer; Vomiting; Pain worsened; Back ache; Thyroid nodule; Lung nodule; sciatica; Nauseous; Light-headed; Feelings of weakness; Difficulty in walking; This is a solicited report from a marketing program received from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular on 29Mar2021 (Batch/Lot Number: ER8733) at age of 78 years old as single dose for covid-19 immunisation; upadacitinib (RINVOQ), oral from Dec2019 (Batch/Lot number was not reported) and ongoing, at 15 mg, once per day for moderate to severe rheumatoid arthritis. Medical history included non-smoker: secondary tobacco exposure, abstains from alcohol, high blood pressure, glaucoma, rheumatoid arthritis, muscle cramps in legs, cholesterol, acid reflux, and dry eyes. The patient had a relevant medical history of osteoporosis, hiatal hernia, DURICEF allergy manifested by pseudomembranous colitis. The patient had secondary tobacco exposure. She had history of usage of Remicade for unknown indication. Concomitant medications included amlodipine taken for hypertension; vitamin D3 taken for supplementation therapy; ciclosporin (RESTASIS) taken for dry eye and glaucoma; latanoprost taken for eye disorder; folic acid taken for rheumatoid arthritis; methotrexate taken for rheumatoid arthritis; magnesium taken for muscle spasms; fish oil taken for blood cholesterol; omeprazole taken for gastrooesophageal reflux disease; all start and stop date were not reported. Solicited report by a consumer of a female with events of colon cancer metastasize to the liver, kidney cancer that possibly moved onto liver, vomiting, back ache, pain worsened, spot on the lung and kidney stones and non-serious lightheaded, felt weak, could hardly walk, nodule on thyroid and right lung and nauseous with RINVOQ (upadacitinib). On unknown dates, the patient experienced kidney cancer that possibly moved onto liver and nodule on thyroid and right lung. On 29Mar2021, the patient experienced lightheaded, felt weak, could hardly walk and nauseous. On 29Mar2021, the lightheaded, felt weak, could hardly walk and nauseous resolved. In May2021, the patient experienced back ache. On 29May2021, the patient experienced vomiting and pain worsened. On 02Jun2021, the patient experienced kidney stones. On 03Jun2021, the patient experienced colon cancer metastasize to the liver and spot on the lung. On 03Jun2021, the vomiting resolved. On 17Jun2021, the kidney stones resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. On 27May2021, she was sent to the emergency room because of back ache and was given prednisone. In Jun2021, she had a terrible back ache. She thought she had sciatica. In Jun2021, she went to the doctor, physician pressed on her back and she went through the roof. She was vomiting and had pain in her back and her daughter took her to the emergency room and did x-ray and cat scans and she had kidney stones and she was having an ultra sound. Went back to the emergency room from 02Jun2021 until 04Jun2021 because of vomiting and pain. She also had kidney cancer that had possibly moved onto her liver. She had an endoscopy done. The biopsy and other tests to decide what was going to happen. There was a nodule on her thyroid and her right lung. She felt ok and had a little backache at times, but she was taking. She already had the COVID-19 vaccines first dose but was advised not to had the second dose because of the adverse events she experienced after the first dose. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 29Mar2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number ER8733. The patient was treated with PREDNISONE. Relevant laboratory and other diagnostic tests included: 17Jun2021 abdominal ultrasound: No more kidney stones; Unknown date biopsy: Unknown; Jun2021 CAT scans: Kidney stones; 03Jun2021 chest X-RAY: Spot on the lung; 04Jun2021 colonoscopy: Colon cancer; 03Jun2021 computed tomography scan: Colon cancer metastasize to the liver; 04Jun2021 endoscopy: Hiatal hernia; Jun2021 endoscopy: Unknown; Unknown date lab tests: Unknown; Unknown date ultrasound: Unknown; Jun2021 X-RAY: Kidney stones. The action taken in response to the events for suspect product upadacitinib was dose not changed. The outcome of events colon cancer metastatic, kidney cancer, and lung disorder was not recovered, events vomiting was recovered on 03Jun2021, kidney stones was recovered on 17Jun2021, light-headed, feelings of weakness, difficulty in walking, and nauseous was recovered on 29Mar2021, events back ache, and pain worsened was recovering, of other events was unknown. Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of colon cancer metastasize to the liver, vomiting, back ache, pain worsened, spot on the lung, kidney stones, lightheaded, felt weak, could hardly walk, nodule on thyroid and right lung unknown onset, nodule on thyroid and right lung unknown onset and nauseous was not provided. The reporter's causality for the event(s) of kidney cancer that possibly moved onto liver with RINVOQ(UPADACITINIB) was no reasonable possibility. (Withheld) opinion is that the events of colon cancer metastasize to the liver, kidney cancer that possibly moved onto liver, spot on the lung, nodule on thyroid and right lung unknown onset and nodule on thyroid and right lung unknown onset are not assessable. (Withheld) opinion is that there is no reasonable possibility that the events of vomiting, back ache, pain worsened, kidney stones, lightheaded, felt weak, could hardly walk and nauseous are related to RINVOQ(UPADACITINIB). The reporter's assessment of the causal relationship of the events with the suspect vaccine was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Considering the close temporal association, a causative role of BNT162B2 vaccine for the reported Light-headed, Feelings of weakness, Difficulty in walking, and Nauseous cannot be excluded. All other events are considered unrelated to BNT162B2 vaccine.

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.

Patient started to have trouble breathing around February 10th. She also complained that she couldn't swallow very well since the 2nd vaccine on February 2nd. On February 12 she called in a panic. Her lips were swollen and then her tongue started to swell. I took her to the ER where they sent us to a large hospital. They ran all sorts of test. Blood work, CT Scan, ultra sound. No one could tell me why this was happening. They gave her antibiotics and steroids and the following morning on February 13th she was discharged. The next morning on February 14, patient called me again in a panic. She couldn't breath and couldn't swallow. Her lips, tongue, and under her chin were swollen, hot, and hard as a rock. I rushed to get her and took her back to the hospital. She was in the ER for about 8 hours where she was almost intubated as her airway was close to closing off. She was moved up to the ICU that day and stayed in the the ICU until February 19th. During that time, they ran all the same tests, blood work, CT Scan, ultrasound and no one could tell me why my mom was having this reaction. After we returned home I received a call from the ICU doctor who was checking on her as they had more patients come in with the same symptoms post covid - vaccine. She advised to file this reaction with all the information I had and told me that patient was not to get the booster if one was required later.

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.

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.

pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, chest and back; pains radiating down right arm, chest and back; nausea; Vomiting; severe chest and back pains on right; severe chest and back pains on right; This is a spontaneous report from a contactable Other Health Professional (patient). A 79-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient medical history was not reported. Concomitant medication in two weeks included citalopram, levothyroxine, atorvastatin, anastrozol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 3rd day (21Dec2020), the patient experienced severe chest and back pains on right at time of 12:30 AM. On 4th day (22Dec2020) pains radiating down right arm, chest and back, nausea and vomiting. On 5th day (23Dec2020) pain under right arm pit, very stiff neck, pain radiating into ear. Temperature was normal. On 6th day (24Dec2020) most symptoms dissipated. On 7th day (25Dec2020) almost back to normal. No treatment received for the events. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.

Dizziness, Diarrhea, Palpitations & Tachycardia Narrative: Patient remained in facility for 15 minutes after receiving vaccination. Upon ambulating to depart facility, patient returned to area complaining of dizziness and fast heart beat. Patient was immediately seated and vital signs were obtained. 0954- BP 150/82, pulse 80, Oxygen saturation 95%, and temp 97.8. Patient drank 8 ounces water. Patient reported feeling better after 10 minutes. Repeat vital signs at 1007 BP 127/74, pulse 80, oxygen saturation 95%. Patient with no further complaints of dizziness or fast heart beat. Patient did not verbalize any other complaints. Patient denied escalation to emergency department. Condition was resolved prior to leaving facility. Patient left facility ambulatory without any difficultly, and was accompanied by family member. Patient instructed to call 911 and report to nearest emergency room for any further issues or complaints. Patient verbalized understanding of instructions in her own words.

dizziness; weakness; nausea; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient non-pregnant received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E13246), via an unspecified route of administration on 06Jan2021 13:00 at single dose in right arm for covid-19 immunization. Medical history included arthritis. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination was reported as yes. The patient experienced dizziness, weakness, nausea, diarrhea on 07Jan2021. The patient was not received any treatment. The outcome of the events was not recovered.

Jan 1st, patient had a seizure after breakfast. Temperature was 98.5 Pulse 95. B.P. 160/70 Two hours later another seizure at the home, with emesis, Sent to hospital at 2pm. Focal Status elepticus. Seizure activity along with continuous persistent activity with emesis throughout the 12 hour time in the ED. Seizure during the CT scan.

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.

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

Irregular heart rate pretty severe for a couple of hours then I had chills and enough to make my teeth clatter and also dry heave for some hours until I took the medicine under the tongue and it got better. I still have shaking in my hands and feet as well.

WITHIN 5 MINUTES AFTER VACCINATION :SWOLLEN LIPS,DIFFICULTY SWALLOWING ,SENSATION OF THROAT CLOSURE, DI FUSE RASH (ARMS ,LEGS ,BACK) ,SWOLLEN NOSE AND FACE AREA AROUND.

slept all day; very sore arm; woke up trembling with chills; terrible chills; headache/bad headache; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included major reaction to eating conch, and tested positive for COVID on 22Nov2020 There were no concomitant medications. Patient read that was not a good thing to do, to get the vaccine after only 2 months instead of 3 from diagnoses. When she had COVID she had major headache, chills, and diarrhea. After the vaccine she had had the same thing, terrible chills, bad headache and diarrhea on Jan2021. The side effects say that this was normal but she wants to know should she have waited the 90 days before getting the vaccine. Patient still had the headache and chills but she took an Imodium and the diarrhea was better. Patient had also fatigue in Jan2021,and slept all day yesterday (13Jan2021). She has had a very sore arm and at 2am she woke up trembling with chills on Jan2021. Outcome of the event chills and headache was not recovered, for diarrhea was recovering and for the remaining events was unknown. Patient had a major reaction to eating conch and wanted to make sure there was no shellfish involve in the vaccine. Information on the batch/lot number has been requested.

Dizzy and light headed, mild nausea, weak and tired with occasional shortness of breath. Elevated blood pressure causing headaches. I have been unable to send this via the phone/text. I am exhausted from this continued distress. Normally very active and healthy.

Little nauseous; This is a spontaneous report from a contactable consumer. A 79-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration on 14Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetes mellitus, hyponatraemia, Macrocytic anemia, Bad back and visual impairment. There were no concomitant medications. The patient previously took tylenol and tramadol for back pain. The patient experienced little nauseous on an unspecified date. The outcome of the event was unknown. Information on the batch number/lot number has been requested.

urine issues/kept going to the bathroom to urinate; upset stomach; diarrhea; felt like she was going to faint, pass out at any second; dizziness; Had a funny taste in her mouth; felt very weird, strange; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events for two patients (one is patient self). This is the first of two reports. This 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration to right arm on 13Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included allergies to Sulfas, Penicilins, and Avelox, Sulfa or Penicillin allergies since she was a child and had the Avelox allergies about 15-16 years ago. None concomitant medications. Patient did not receive any other vaccines that day or 4 weeks prior. Did get the original Shingles vaccine about 3 years ago and then they came out with the new one and she got the first dose of that and believes she had a reaction to that one, thinks it was a rash. Also had the flu shot and she usually gets sick with it, but didn't with this last one. Thinks her body is just delicate. No vaccines administered on same date. Patient had the Pfizer BioNTech vaccine on 13Jan2021 15:00 and she was fine. She had a reaction the following day (on 14Jan2021). At 11am the next day she got very dizzy and felt like she was going to faint, pass out at any second. Used cold compresses and drank water and took deep breaths, but she didn't pass out. She had a funny taste in her mouth. Then from that time until about 7pm she had urine issues and kept going to the bathroom to urinate and had diarrhea and upset stomach. Patient felt like she was out of her body, felt very weird, strange. Doctor stated she maybe had a reaction to the vaccine and recommended for her to take Tylenol. She didn't take it until right before going to bed. She was able to sleep on 14th night. Woke up the next morning and was fine. She didn't see any of these reactions listed and that happened. Patient explained to a friend of the reactions and the friend mentions that she also had a friend who had the vaccine and had the same exact reactions, everything. Everything improved and stopped the next morning she was fine, on the 15th. No Emergency Room or Physician Office visit. The events outcome was recovered on 15Jan2021. It was just a span of time and she has to assume that it was the vaccine since she has never had that before. Patient does not know if she should blame the vaccine because she also has a lot of allergies to a lot of antibiotics and does not know what caused her reactions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021065869 Same reporter/ vaccine/ AEs, different patient

Felt fine the day of event, during the night she felt like she had a heavy head, but when she woke up around 8:00 and she realized that something was very wrong, she could not sit up due to nausea and the room spinning. She texted her daughter who is a nurse and got there about 1:00 PM, she was still in bed. When she tried to sit her up she felt like she was going to throw up. She put her legs over to the side of the bed, and she felt like somebody was pushing her with her daughter over a cliff, in a tornado and on a Ferris wheel. She started vomiting and having diarrhea. She had heard about an epley maneuver and after a time she sat her up again and still had the previous feeling of going off a mountain in a tornado. She did the epley maneuver and tilter her head to the left and was still very dizzy but not as bad. She then tilted her head to the right and it was not as bad. Things started to settle down and eventually she was able to get up, still nauseated but 90% better. She was able to go to the restroom with her daughter's help. She stayed in the bed all that day and finally in the evening was abler to keep food down. She limited her distance to the bed to the bathroom. Her doctor was notified and called in some nausea and vertigo medicine (meclizine), which he did and only took 2 doses of that. The next morning she went up and down the stairs to make sure she was able to. She was very, very cautious but each day has been better. On 2/2/21 she called and got an APT with ENT but will not see him in a couple of weeks. They are going to send a therapist tomorrow to evaluate her for the vertigo. She is scheduled for the 2nd vaccine on 2/11/21. Saw her internist today and he evaluated her and did 2 blood tests and sent the referral for the therapist to come tomorrow.

diarrhea; sore abdomen/ abdominal pain; reflux; aches/pains; her voice is grabbly; has a sore throat; painful esophagus; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 15Jan2021 05:30 at a single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Patient receive the vaccine Covid vaccine and had no problems. The next day on 16Jan2021, she had aches and pains but found them not unusual. 24 hours later that she had reflux on 17Jan2021. She had reflux all day on 17Jan20210 and took Gaviscon all day. Patient had very serious reflux Monday (18Jan2021) morning and took Prilosec. She also had a sore abdomen/ abdominal pain and took four Gaviscon that evening. She had diarrhea and stated that the same thing happened Tuesday (19Jan2021) but she was little better in the afternoon. She had no Gaviscon then. On Wednesday (20Jan2021), she very bad reflux all day, sore abdomen and diarrhea. Patient took Prilosec in the morning one hour before eating and took Gaviscon all night. Her voice was grabbly and she has sore a throat, painful esophagus and abdomen on Jan2021. She felt better the morning of 21Jan20221 and had Prilosec. She still has diarrhea and loose stool, and felt better after going to the bathroom. Her healthcare provider and the nurse stated to keep taking Prilosec. Patient wanted to know if this may be a side effect though not very prominent that is out there but not very common. Outcome of the event of diarrhea was not recovered while for the remaining events was unknown. Information on the lot/batch number has been requested.

Severe headache 4 hours after shot, generalized muscle weakness all over 12-15 hours after shot (felt paralyzed), fever (100.5) 12-15 hours after shot, nausea and moderate abdominal cramping morning after shot, extreme fatigue for 1 week following shot

Stomach uncomfortable; Vomiting; Had cough that would not quit; This is a spontaneous report from a contactable consumer (patient). This 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot # EL3246), via an unspecified route of administration on 21Jan2021 at single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were none. Patient took COVID 19 vaccine was because of her age group and risks. The patient experienced stomach uncomfortable, vomiting and had cough that would not quit, all on 21Jan2021. Clinical course reported as follow: patient stated she had yesterday that got first COVID vaccine. Stated that she had it at 9:00PM. Stated that she was fine until 3:30. Stated that her stomach was uncomfortable. Stated that at 7:00 she started vomiting for 4-5 hours. Had a cough that would not quit that started at 7PM. Patient stated that her stomach and cough resolved at midnight. Stated that she recovered completely from both. No treatment received. Outcome of the events was recovered on 21Jan2021. No investigation assessment.

Soreness at the site in injection. Couldn't sleep that entire night. Woke up with sweats and chills. Felt absolutely exhausted the following day with little to no appetite. Slept soundly (unusual for me) that night and felt absolutely fine the next day.

soreness at site; swelling at site; fatigue (slept for 12 hours next night); abdominal pain; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown) intramuscular at single dose for COVID-19 immunisation on 20Jan2021, at 05:30 PM. The patient did not receive other vaccine same date. Relevant history included apnea, depression, high blood pressure, reflux, 2 strokes, restless legs and allergies with Clarithromycin, compazine, Hydrocodone; kiwi, peppers. The patient was not pregnant. The patient was not diagnosed with COVID prior vaccination. The patient did not have COVID test post vaccination. Relevant concomitant medications in two weeks includes amlodipine, atorvastatin, duloxetine, plus more. The patient did not receive other vaccine in four weeks of vaccination. The patient experienced soreness at site, swelling at site, fatigue (slept for 12 hours next night); abdominal pain (may be unrelated) since 20Jan2021 at 08:00 PM. The events reported as non-serious. Treatment therapy included Acetaminophen. Outcome of events was resolved. Information about lot/batch number has been requested.

Patient reported fever 101.9F for atleast 24hrs after vaccination, fatigue, diarrhea, chills, and headache

Arm got a tad sore; makes her tired; Nausea; Chills; Hot flash; This is a spontaneous report from a contactable nurse via the Pfizer-sponsored program Pfizer First Connect. A 79-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), via an unspecified route of administration on 13Jan2021 at a single dose for covid-19 immunization. Medical history included gastroparesis. Concomitant medication included estradiol, levothyroxine sodium (SYNTHROID), mirtazapine, calcium, colecalciferol (VITAMIN D). It was reported that the patient got the vaccine on the 13Jan2021. Wednesday and Thursday night, she was fine. On Friday (15Jan2021), she started getting nausea and chills. Then Saturday she was ok again. Then Sunday the nausea came back. She had had nausea since then. It comes in waves. When it is kind of mild, she doesn't feel so bad. This morning it has been bad. It makes her tired when the nausea gets like this. It may subside during the day. When she firsts get nausea, she gets hot flash. The patient's arm got a tad sore, but only a little. The outcome of the event chills was recovered on an unspecified date, nausea was not recovered while unknown for the other event.

About 30 minutes after the shot, sudden very weird feeling, visual distortion, confusion, disoriented (now believe was sudden drop in blood pressure), followed by mouth feeling odd, tongue felt too big, difficult to swallow, followed by sensation of intense heat. This all lasted about 5-10 minutes. Resolved on its own. Felt a little shaken but OK afterwards.

Loose stools; stomach ache; body became hot up to her head then red haze seen in room/Body became hot like a hot flash again; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration at Left arm on 21Jan2021 15:45 at SINGLE DOSE for COVID-19 immunization. The patient was not pregnant. Medical history included high blood pressure, arthritis, known allergies: sulfa drugs, dust, mold. Concomitant medication included atenolol, atorvastatin, lactobacillus nos (CULTURELLE), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol acetate, riboflavin, selenium, silicon dioxide, sodium metavanadate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc (CENTRUM SILVER ADULTS 50+). No other vaccine in four weeks. The patient's body became hot up to her head then red haze seen in room on first day 21Jan2021 07:00 PM. Body became hot like a hot flash again, no color haze on the second day (22Jan2021). Loose stools and stomach ache on third day (23Jan2021). No treatment received for the events. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the events was recovered in Jan2021.

Dizziness and nausea began overnight on Feb 4-5, continuing throughout the day on Feb 5. Went to ER for treatment the evening of Feb. 5. IV fluids administered to treat mild dehydration. Symptoms eased temporarily, then increased on Feb 6. As of today (Feb 10), symptoms have steadily improved, but not yet fully recovered.

Client reports developing shingles after vaccination on right side of face and has right eye involvement. Client reports started with runny nose and watery eyes on 2-1-2021. Was recommended to get COVID-19 testing which was completed on 2-2-2021 and results returned negative. Client was given prescriptions for amoxicillin and prednisone dose pack on 2-2-2021 by COVID testing site practitioner. Client then developed nausea, vomiting and diarrhea after starting amoxicillin and stopped taking it. She spoke with her MD who placed her on another ATB, which she has not taken. On 2-4-2021, she went to the ER as recommended by her PCP for dehydration. The ER noted eye swelling and that she had increased eye pressure after running some tests. She saw her eye doctor on 2-5-2021 and is scheduled for an MRI and MRA on 2-11-2021 and will follow-up with eye doctor on 2-12-2021 as well.

Chills and fever. It was only 99.8 and then later in the day it did go to 100.3 and nausea. Weakness.

slight nausea off and on for about a week, rashes on arms and back -- no treatment -- nausea still present occasionally

Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild

Severe dizziness and nausea since Saturday 2/13/2021 . Called doctor who prescribed medication. Nausea has abated, but dizziness is still an issue. This is the fourth day.

Started with aching arm followed by shaking chills, fever, body aches, headache, nausea, and lasted about 24 hours.

2/26 - severe flu symptoms (achy, no energy), drastic increase in memory related issues (has mild cognitive impairment) 2/28 - vomiting and diarrhea

Second dose of Covid vaccine given on 2/7/21. Administered at central location. Taken to hospital for possible stroke like symptoms with drooping to right eye and mouth, difficulty swallowing, and feeling odd. Admitted and treated from 2/18/21 thru 2/22/21.

tingling lips, itchy red cheeks - on the way home Saturday muscle aches from neck to ankles - during the night Saturday to Sunday stuffy nose, dry cough, fatigue, chills (no fever), nausea, sore arm - Sunday and Monday on third day the only thing remaining are chills sought no treatment

nearly fainting; Head ache; fatigue; upset stomach; vomiting; chills; new mouth sores; painful arm; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9365) via an unspecified route of administration in the right arm on 15Feb2021 12:00 AM at single dose for covid-19 immunisation. Medical history included allergy to bees and wasps. The patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin and olmesartan medoxomil. The patient previously received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration in the right arm on 21Jan2021 12:00 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After receiving the second dose, the patient experienced headache, fatigue, upset stomach and nearly vomiting, chills, nearly fainting and new mouth sores, painful arm on 15Feb2021 13:15. No treatment was received for the adverse events. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovered in Feb2021.

At approximately 8PM I began to have significant chills. They lasted most of the night. By morning I knew I wasn't feeling well. I wan not hungry and as a result only had a cup of tomato soup with cracker that day. Later in the evening I had a cup of warm milk. Periodically I would have chills and muscle aches especially in my legs. I went to bed early and am much better today. I am also getting my appetite back.

At about 4:45 AM the following day after receiving my second Covid-19 vaccine shot, I experienced a reaction including itchiness all over my body, redness all over my body, abdominal discomfort, diarrhea, vocal changes, lightheadedness, felt hot (but didn't have a temperature, 97.4 degrees Fahrenheit), joint pain. Took Benadryl, and symptoms resolved after about an hour.

1120 Rec'd vaccine; while checked on, no complaints At 1140, let nurse know with further questioning, upon sitting after vaccine, slight nausea and lightheadedness, headachedenied issues with shortness of breath, no swelling of lips, no apparent hives/itching, slightly improved. Notes walked quite a far way from parking lot; would now like wheelchair ride back . BP 120/70 ; HR 52-58 notes on metoprolol; p ox 96%. Monitored another 10-15 minutes, took sips water; felt ready to go. Knows to seek medical attention if further symptoms. Encourage to follow up with MD re: tiredness, low pulse; notes it is normal for her in 50s/60s.

Pt's daughter called around 4:30pm on 3/11/21 (day 2 post vaccination on 3/9/21) reporting that pt woke up feeling nauseous all day & vomited profusely at 4:00pm. Advised to stay hydrated and take nausea medication patient had at home & to call back with any changes. If not improved in 6-12 hours, advised to call physician for evaluation.

Shocking and immediate onset of painful sensation on right side of face.- similar to feeling when shots given for dental work begin to wear off. Tingling pain from hairline to mid throat, from behind ear to right side of nose. areas of numbness, , noticeable swelling of lymph node under right chin. Painful to swallow, painful to open mouth, pain in jaw like having a really bad tooth ache. this is nine days. I had a titanium tooth implant in the last six months. Painful to chew food - eat soups, ice creams, soft food like bananas.

fatigue, diarrhea, body aches, chills, sore throat, runny nose, headache, abdominal pain lasting for 2 weeks and not improving

Nausea; Chills; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (BNT162B2, lot number and expiry date were unknown), via an unspecified route of administration on 02Feb2021 at a single dose on the left arm for COVID-19 immunization. Medical history included ongoing stage 4 lung cancer from Dec2019 and chemo from Apr2020. The patient had no concomitant medications. On 02Feb2021, the patient experienced nausea and chills. The patient reported that she had her first Pfizer shot on 02Feb2021. She had just a few problems in the middle of night afterwards- nausea and chills. That night she had nausea and chills. It lasted for about 30 minutes. She just laid in bed. She was fine after that and was fine the next morning. Outcome of the events was recovered on 02Feb2021. Information on the Lot/Batch Number has been requested.

nausea; She was just not quite herself; feeling hot and sweaty; feeling hot and sweaty; not feeling well; shaky; nervous; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration, on 02Feb2021 12:00 at a single dose on the right arm for COVID-19 immunization. Medical history included asthma, knee surgery, and bulging disc. The patient had an MRI on an unspecified date in Jan2021 (a week and a half prior to the date of initial report) with result of bulging disc. Concomitant medications included fluticasone furoate (ARNUITY ELLIPTA) for asthma; She was supposed to take 1 puff a day. However, being in the house, she had no problems, she had maybe used it twice a week since she hasn't had any problems, she last took 1 puff on 01Feb2021). She was also taking vitamin pills concomitantly. On 04Feb2021 23:00, 2 days after the vaccine, the patient had sweats, was wringing wet, and was not feeling well. Her hair was wet, and she was sweating. She was okay on the morning of 05Feb2021 but not herself. She had a little nausea on 05Feb2021. She was just not quite herself on 05Feb2021 but doesn't have the sweats. She further reported that she had her first shot on 02Feb2021 12:00. She was fine and had no problems. However, on night of 04Feb2021, before bed, she started getting hot and sweaty, like she was wringing wet. She didn't feel good, but 2 days had gone by and she was fine. She also went to bed with something like chills (later clarified as not chills), she went to sleep on the morning of 05Feb2021 and felt okay but not that great. When queried when the chills started, she said that it was not really chills, she was just very sweaty, wringing wet. She stated that she never sweats, and in this case her whole hair was wet. Being older, she was wondering what was going. Her feeling hot and sweaty subsided during the night. She did start to feel nausea, or she thought maybe she hasn't had anything to eat and so had a half banana and then she was okay. She thought she was hungry and felt funny, she had the half banana and was okay. She also felt a little shaky and nervous on 04Feb2021; however, it all subsided after going to bed. At the date of report, 05Feb2021, she felt okay but she didn't feel completely herself. Her second dose is scheduled on 26Feb2021 at 9:15 AM. Outcome of events feeling hot and sweaty was recovered with sequel on 05Feb2021. Outcome of event not feeling well was unknown. Outcome of event nausea was recovered on 05Feb2021. Outcome of the events shaky and nervous was recovered on 04Feb2021. Outcome of she was just not quite herself was not recovered.

sore throat, followed by headache and right ear pain. Nausea and fever of 101.0 on March 8th, in addition to previous symptoms. In the emergency department on March 11th with complete right facial droop consistent with Bell's palsy; this has persisted as of today, also with evidence of right serous otitis media

Chills; acid reflux; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL8982, via an unspecified route of administration, administered in left arm on 05Feb2021 as single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 on 14Jan2021 (lot number: EK9231) for COVID-19 immunization. The patient mentioned that she had to go to the doctor with acid reflux on 06Feb2021. She was taking some medication for the acid reflux and it was getting better. On 12Feb2021, the patient was having some chills. The patient was feeling a little bit better because she took a Tylenol. The outcome of the events was recovering.

After 4 1/2 days, I developed retching and diarrhea. Day 2, the retching stopped, but, I had mild nausea for 26 days. Still, after 31 days, I continue to have mild diarrhea and intestinal mucus, and enough intestinal flatulence to fill a hot air balloon.

nausea, severe headaches and bodyaches, extreme weakness, vomit, cough, fever, chills, unable to perform daily activities, took bonine and tylenol

Uncontrollable shaking, inability to walk, inability to talk, hands hot to the touch, incontinence, inability or desire to eat - all began 4:30pm on the day after first vaccine given (Tuesday 2 Mar 2021) . Patient had to sleep in a reclining chair for 3 nights and was prompted to drink water and was given one Tylenol 650mg. During this time patient needed INCREASED assistance with toileting and could not have a shower with assistance (instead was given a sponge bath). Symptoms lessened over the three days and patient returned to her baseline by Saturday 6 Mar 2021.

Body hurts everywhere, major diarrhea and going many times a day that stool looks mainly clear no signs of blood. Lots 4 lbs in three days

On 3/11 pt reported severe n/v to pharmacy - called back 3/12 to state sx resolved. On 3/22 pt called back stating sx started again 3/13 and lasted thru the week. Pt currently in emergency room post fall on 3/21 and getting fluids for severe dehydration

I went to the bathroom and the next thing I know was that I woke up on the bathroom floor, I passed out for couple of minutes; Chills; Weak; Dizzy; Nausea; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 79-year-old, on 06Mar2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on an unspecified date, as SINGLE DOSE for covid-19 immunisation. After taking the second dose on 06Mar2021, the patient waited for half an hour and there was no problem. The patient came home no problem. In the middle of the night, the patient woke up with chills, the patient know that is one of the side effects, she was okay and not worried about it. The patient took her temperature that was normal but then couple of hours later, she went to the bathroom and the next thing she knew was that she woke up on the bathroom floor, the patient passed out for couple of minutes. Then she went to bed and was very weak and dizzy and nausea. The patient didn't want to call right away or did not wanted to go to the emergency room. The patient called her friend because she got very nervous and she said come back to her house. The patient took a Benadryl (treatment) and came back home and slept few hours. The patient woke up this morning, felt pretty good and took Benadryl (treatment) and then came here of her friend house and took Benadryl (treatment) again few minutes ago and four hours later. The patient had several things like these like she was dizzy and had nausea. The patient felt okay now and she doesn't want to go to emergency room and she seems to be fine now. The patient was dizzy, nausea and passed out. The patient had a chills and experience sore arm. Outcome of the events was recovered in Mar2021. Information on the lot/batch number has been requested.

It started with a feeling as though I was getting a sore throat. I took an Emergen-C drink and went to bed at normal time. I also had more drainage than normal from my head. During night I felt a fierce sore throat. Next day, sinus headache, slight sore throat, additional drainage from head. Last meal that day was lunch. Going to bed, I vomited. Next day, sinus headache, drainage, cough and yellow phlegm from lungs--a cough. Took Tylenol during these times. Vomited before bed. Next day I took Alka-Seltzer Plus Cold meds in a.m. and again in afternoon. Felt better. Ribs very sore from coughing. Appetite began returning. Congestion much improved. Following day (today) still congested but improved. No meds so far today.

Stood up to go to the bathroom and could not put her right leg down; thought she was having a heart attack or a stroke or something; Fell on her right side; Cerebrovascular accident; Diarrhea; Nose running; Her calves were so sore, like having charley horse where her calf muscles were so tight it hurt; like having charley horse where her calf muscles were so tight it hurther calf muscles were so tight it hurt; her calf muscles were so tight it hurt; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 18Feb2021 (Batch/Lot Number: EN6201) as single dose for COVID-19 immunisation. Medical history included family history of glaucoma from 2019 (Her mother has Glaucoma); memory ain't that good (she puts everything on her calendar because her memory ain't that good); ongoing irregular heart beat since 2006 (periodically when she goes to the doctor they have her walk the treadmill and stuff like that); ongoing diabetes since 2011; and was allergic to Penicillin (as a kid she was bitten by a dog, she must have been about 12 years old, went to hospital they gave her a shot of penicillin, her head blew up, she looked like a monster, she went back they gave her Streptomycin). Concomitant medication(s) included brimonidine taken for glaucoma from 21Feb2021 to 01Mar2021; latanoprost taken for glaucoma; apixaban (ELIQUIS) taken for arrhythmia, and dyspnoea from 2019 and ongoing; and metoprolol taken for arrhythmia. The patient was administered with her first dose of COVID-19 vaccine on 18Feb2021. It went beautiful, she did not have any aftereffects or anything initially. On 01Mar2021, while in her own apartment she stood up to go to the bathroom and could not put her right leg down; she thought she was having a heart attack or a stroke or something and she fell on her right side. She went to the hospital where she was hospitalized overnight for observation and testing. MRI performed during that hospitalization had result of Cerebrovascular Accident-CVA. She also reported onset of diarrhea and nose running around 01Mar2021. When she went to the hospital on 01Mar2021 she was laying down, and when the doctor moved the blanket to test her legs her calves were so sore, like having charley horse where her calf muscles were so tight it hurt. The events were reported to have required a visit to the emergency room. They did not find anything else during hospitalization with testing. The only thing she can think of related to these events was the COVID-19 vaccine. She called to ask if she should or should not get the second dose of the COVID-19 vaccine as scheduled for 11Mar2021 relative to these events. She was scheduled for second dose on 11Mar2021, but she is scared because of events that occurred 01Mar2021. The outcome of the events diarrhea, "Nose running", "Her calves were so sore, like having charley horse where her calf muscles were so tight it hurt", "her calf muscles were so tight it hurt" was recovering, and for other events was unknown.

Heavy Head; Tired; Chills; Diarrhea Symptoms; This is a spontaneous report from a contactable consumer (the patient). A 79-year-old female patient received the first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 25Jan2021 15:00 (lot number El 9269) and on 12Feb2021 17:30 (lot number EL9262), respectively, both via an unspecified route of administration in the left arm (at the age of 79-years-old), as a single dose for COVID-19 immunization. The patient's medical history included: allergies to penicillium and sulphur. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included: atorvastatin, multivitamin, "vitamin C K E calcium". The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Jan2021 09:00, 4 days after the first dose, the patient experienced heavy head, tired, chills and diarrhea symptoms, lasted about 6 hours. The patient had to take 2 antidiarrhea pills. Seven days after the second dose, the patient experienced the same symptoms for the same amount of time. The patient did not receive treatment for heavy head, tired, chills. The clinical outcome of the events was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

First and second day (1/21/2021 and 1/22/2021) after receiving vaccine: sore arm, slight fatigue. Fourth day (1/25/2021), extreme vertigo, nausea, vomiting, weakness, unable to stand. Husband called primary care physician who said I should go to ER immediately. Blood pressure elevated. Fluids administered. Chest X-ray, CT head. Morning of 1/26/2021,MRI brain w/o contrast. Later same day: MRA head, MRA head IAC w/ and w/o contrast. MRI IAC, MRV w/o contrast. Ultrasound carotid duplex bilateral. Diagnosed with Right Vestibular Schwannoma, benign, measures approximately 1.5 x 0.9 x 1 cm. Remained hospitalized until 1/27/2021 about 7:00pm. Follow-up with physician. primary care physician; (Otologist and Neurotologist,) and (Clinical Audiologist) at. Follow-up treatments will include consultations with above physicians, additional MRIs and CTs, and possible targeted radiation or surgery.

Joint pain 1st day to present, deep red skin lesions 3rd day to present, welts, head blisters4th day to present, nausea 2nd day, extreme fatigue 1-4 days,

Initial rash on forehead after first injection. After second dose several weeks later she immediately (next day) had hip pain and difficulty walking. It continued to worsen every day. On the 9th day after the second dose she started vomiting. Currently she has joint and muscle stiffness, extreme weakness and fatigue. She can hardly lift up her toilet seat. Her PCP started her on oral prednisone and she is now on 10mg qod.

She has not had a bowel movement; 20 hours of diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6200), via unspecified route of administration on 01Mar2021 at 14:00 (at the age of 79 years) at a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medication were reported as none. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. Patient called to report that her second dose is due on 25Mar2021 (24 days after the first dose) and wanted to know if this is ok to do. She stated that she had 20 hours of diarrhea yesterday (10Mar2021) and today (11Mar2021), she has not had a bowel movement. The events did not result to emergency room/ physician clinic visit. The outcome of the event 20 hours of diarrhea was recovered on 11Mar2021 while the other event was unknown.

Very severe malaise, nausea, lack of appetite, weakness, urinary frequency (every 15 min x 2 days - urine totally colorless though I was not drinkiing anything, yellow tint gradually reappeared over next 3 days), no fever, memory and concentration much worse than usual, could not even think well, joint pain ,prolonged excessive sleepiness (nearly has resolved after 2 weeks)

presented with chest pain onset around 1800 this evening. She describes it as "an elephant sitting on [her] chest" that began suddenly and was constant until she received pain medicine in the ED. She had associated shortness of breath and nausea. She did receive her COVID-19 vaccine today. She denies fever, chills, cough, vomiting, abdominal pain, diarrhea, constipation, urinary sx.

belly cramps; watery bowel; Felt tired; No pain or red at injection site just little tender to touch; This is a spontaneous report from a contactable consumer or other non hcp. A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9263 ), dose 1 administered in Arm Left on 29Jan2021 11:15 as single for covid-19 immunisation. Medical history included breast cancer from 1984 and it was fully recoverd and cured. The patient's concomitant medications were not reported. It was reported that On 29Jan2021 03:00 PM after 3 hours of vaccination patient experienced felt belly cramps, watery bowel. Felt tired, had nap. Much better evening. No pain or red at injection site just little tender to touch. It was reported that all the events were recovered.

not feeling well, weak; not feeling well, weak; freezing/chills; aches and pains; Nauseated; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported that she started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), Pfizer Covid vaccine manufacturer; unspecified, NDC number, expiry date; unknown, intramuscularly from 26Jan2021 at 12:45 pm to 26Jan2021 at 12:45 pm at single dose on left arm, towards the shoulder up high for prevent Covid. Vaccination facility type; hospital, Vaccine was not administered at military facility. Patient was 79 years old, weight; 77.11 kg, height; 155 cm at the time of vaccination. Patient medical history, relevant tests and concomitant medications were reported as none. Past drug event included soreness with flu shot (drug name unspecified). Patient did not have name, lot, ndc, or expiration date for the flu shot. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available, additional Vaccines Administered on Same Date of the Pfizer Suspect and prior Vaccinations (within 4 weeks) were reported as none. Patient experienced not feeling well, weak, freezing/chills, aches and pains and nauseated from 26Jan2021 at 12: 45 pm to ongoing. Patient got her Pfizer Covid vaccine on on 26Jan2021 at 12:45 pm, Tuesday afternoon. She has not been feeling well since then. She was freezing, she had the chills, aches and pains, she is really kind of nauseated. Nausea is the most irritating thing right now and it seems like chills have gone away. She asked how long does this last and is there anything she should be done. Advised to contact hcp, HCP: no email. All her symptoms started Tuesday night. She has had to stay covered up all the time. She feels kind of weak, and she has been laying around covered up, states that could make her sore since she is not up and doing anything. She is not throwing up, she is queasy, she does not want to eat anything like she is afraid. Patient declined any treatment given. The reported adverse event did not require a visit to emergency room or physician office. The outcome of events was recovering for chills and not recovered (From 26Jan2021 to ongoing) for other events . Investigation assessment; no.

This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number and expiry date were unknown), via an unspecified route of administration on 09Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization; and liraglutide (VICTOZA), via an unspecified route of administration from 10Feb2021 to an unspecified date at unknown dose, weekly for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported that everything was going fine until she had her COVID-19 vaccine on 09Feb2021, and then on 10Feb2021 she had the liraglutide injection. That's when everything went wrong and had to be hospitalized. She is losing her magnesium and her potassium. She had diarrhea, hadn't eaten in 5 weeks, was throwing up, and lost weight. She just can't eat, everything tasted so bland. She is getting better now though. The action taken for liraglutide was unknown. The outcome of the events was recovering. No follow-up attempts are possible; information about the lot number cannot be obtained.

delirious; could not even form a thought; Dry cough; difficulty breathing; vomiting; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 79-year-old, administered in Arm Left on 23Feb2021 13:30 (Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included hypertension, glaucoma, and COVID-19. The patient had no known allergies. The patient was not pregnant. Concomitant medication included amlodipine taken for an unspecified indication, start and stop date were not reported; latanoprost taken for an unspecified indication, start and stop date were not reported. The patient experienced delirious, could not even form a thought, dry cough, difficulty breathing, vomiting on 24Feb2021. Adverse event: February 24; All side effects listed by CDC except vomiting, also had dry cough, difficulty breathing and delirious (could not even form a thought). No treatment received for the events. The outcome of the events was recovering. The event delirious was considered as serious (medically significant). No other vaccine in four weeks. The patient was diagnosed with COVID prior vaccination. Not COVID tested post vaccination.

my arm is a little bit sore; shivering; I was so cold; I ached all over; I am getting the flu; I could not walk, it was like I was drunk; pulse rate was like 116; O2 stat was like 98 percent; headache; diarrhea; short of breath when I walk up to the stairs; blood pressure, it was 66 over 48/my pressure came up to 80 over 62 or something/pressure came up to like about 103/my pressure was like 120, the systolic was 120 and diastolic was like 70 something/my pressure was in the 90's; This is a spontaneous report from a contactable Nurse (Patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration on 12Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included High cholesterol. Concomitant medication(s) included rosuvastatin (40, not clarified further); aspirin [acetylsalicylic acid] (ASPIRIN) (81, not clarified further); zinc (50, not clarified further); alendronate sodium (Generic Fosamax) and Multivitamin. Historical Vaccine included First dose of BNT162B2 on 22Jan2021 for COVID-19 immunisation and experienced sore arm (The sore arm went away, it descended in about 12 hours and gracely went away), got really tired and itching (It started itching, okay no problem). The patient experienced my arm is a little bit sore on an unspecified date, shivering on an unspecified date, I was so cold on an unspecified date, I ached all over on an unspecified date, I am getting the flu on an unspecified date, I could not walk, it was like I was drunk on an unspecified date, pulse rate was like 116 on an unspecified date, O2 stat was like 98 percent on an unspecified date, headache on an unspecified date, diarrhea on an unspecified date, short of breath when I walk up to the stairs on an unspecified date, blood pressure, it was 66 over 48/my pressure came up to 80 over 62 or something/pressure came up to like about 103/my pressure was like 120, the systolic was 120 and diastolic was like 70 something/my pressure was in the 90's on an unspecified date; all (non-serious). Reporter (Nurse) stated "I had my first Pfizer vaccine on Friday, I think 22Jan2021 and the only thing I have was the sore arm and got really tired okay and the sore arm went away, it descended in about 12 hours and gracely went away, after that it started itching, okay no problem. I had my second vaccine this past Friday at about 8 O'clock between 8:15 in the morning. As the day went on I felt my arm is a little bit sore, no problem. Okay I went to bed and about 3 O'clock in the morning, I woke up and I was shivering, I was so cold and I ached all over and I said okay I am getting the flu, went back to sleep, by the time I got up in the morning about 6 o'clock the aching was gone but I could not walk, it was like I was drunk. I have a little dog and she was barking to go out and it was like 0 here so I sat there for a minute and I left her out and she started barking, to bring her back and I could not walk, I kept walking into the walls and my house was just this dark, I thought it's so dark in my house so I got my little dog back in, sat down and again and I thought what, maybe I will take my blood pressure, so I did and it was 66 over 48 so I though okay, so I started drinking, I thought I got to eat, I got to drink, so I get that, my pressure came up to 80 over 62 or something, my pulse rate was like 116, my O2 stat was like 98 percent so that was not a problem. So, I ate and drink, as the day went on the pressure came up to like about 103, gradually last night by the time I went to bed, the only thing I had was a little bit of headache, I did not thought enough to take anything for, when I went to bed, my pressure was like 120, the systolic was 120 and diastolic was like 70 something, this morning when I got up my pressure was in the 90's. I was not taking any blood pressure medication, I mean I have but doctor took me off long time ago, I did not I mean I have no aches, I have no pains, I have nothing just a little bit of headache, not even enough to bother me, every now and then I think about it, I also, I mean I thought I have got to the bathroom, I had diarrhea terribly, something, I did not know if any of this is from the vaccine. I have not called my primary, I thought I called him tomorrow I mean I am fine, I am little short of breath when I walk up to the stairs but that is nothing unusual." Causality: Reporter stated "I don't know, I am thinking it does I never had anything like this before but you know I don't know, I don' know, I am just reporting it, I am 79 so I don't know how much this is, I don't know." When probed from where reporter got the vaccine, Reporter stated "I got it the first one at (Institute name)." LOT# of COVID-19 Vaccine administered on 22Jan2021: Reporter stated "You know it's not on my little card, just the LOT# of second one is on here. The first vaccine was 22Jan2021, the second one was 12Feb2021." Reporter provided the LOT# as EM9809 for second shot of COVID-19 Vaccine administered on 12Feb2021 and did not have LOT# of the first vaccine administered on 22Jan2021. Date of side effects: Reporter stated "I think when I started having difficulty was the morning of 13Feb2021." (Not clarified further). Still experiencing side effects: Reporter stated, "No, finally last, I felt yesterday I felt like I kind of had the flu, I have got to get the flu, but it was not enough to stop me, I kept going, I went to work, I did all my stuff, this morning I got up I felt fine." (Not clarified further). Treatment: Reporter stated: No, did not take anything, no. Other medications: Reporter stated "the generic 10 mg." (Not clarified further). Reporter stated "No I was just going to report this, like I said I don't know if this is a problem or not. I have never had anything like this before, I thought this is something you needed to know." Reason of delay: Daily spike of incoming calls due to COVID-19 Vaccine. The outcome of all events was unknown except for event I ached all over, outcome was recovered on an unspecified date.

79 y/o female complain of headache and "empty feeling in stomach." Vital signs checked by onsite EMS. B/P 140/82, P 70. Client monitored for 35 minutes. Reported symptoms "better". Encouraged to follow up with ER or PCP if needed. Verbalized understanding.

suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; exploding diarrhea; extreme tiredness she could hardly walk; muscle aching; Joint pain; felt very sick and couldn't really function; could hardly walk; stayed in bed all day; This is a spontaneous report from a contactable (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2nd via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:00 (Batch/Lot Number: GL9269) as single dose, dose 1st via an unspecified route of administration, administered in Arm Right on 21Jan2021 (Batch/Lot Number: el8982) as single dose for covid-19 immunization. Medical history included apnoea from 2019 to (Verbatim: Apnoea, Diagnosed 2 years ago) , hypertension ( Verbatim: Blood pressure high, diagnosed 15-20 years ago). The patient's concomitant medications were not reported. Family Medical History Relevant to adverse event was none. On 10Mar2021 the patient woke up to a big reaction. The patient had exploding diarrhea, extreme tiredness she could hardly walk, muscle aching, joint pain, felt very sick and couldn't really function, she stayed in bed all day, got better in the late afternoon. It was as if the patient had covid, then it disappeared. The outcome of the events was recovered.

headaches; pretty serious muscle aches; projectile vomiting; fever; chills; massive diarrhea; tiredness; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL8982; Expiration Date: May2021) on 27Jan2021 15:20-15:30 (at the age of 79-year-old) intramuscularly administered in Arm Left as single dose for prevention. The patient medical history were not reported and no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. AE following prior vaccinations was reported as none. Vaccination facility type was reported as hospital and not a military facility. The patient called for information about if her symptoms could be related to the administration of the Pfizer's COVID-19 vaccine. The patient reported that she has massive diarrhea (08:30), projectile vomiting (10:00), fever (10:00), pretty serious muscle aches (11:00), tiredness (07:30), headache (13:00) and chills (08:30) on 10Feb2021. Events fever, Pretty serious muscle aches and tiredness were reported as worsened. The patient reported that she was administered with the first dose of the vaccine 2 weeks ago and she was feeling fine starting with the symptoms today (10Feb2021). The patient reported that she thought it was possible that she has been infected of COVID-19 virus. The patient reported that she considered herself a healthy 79-year-old woman. Received call from the patient regarding the Pfizer COVID 19 vaccine. She had the first vaccine two weeks ago today (10Feb2021). She was having massive Diarrhea, Chills, projectile vomiting, fatigue, muscle aches and fever. She started out with her normal body temp of 97.3 and this morning it was 98.2. She took it an hour later, and it was 98.4 and then it was 100 and now it was 100.2. That was why she was calling. She would like to know if these were side effects. She said she cannot think. She filled out two forms on the second day after the shot. It came up on her email and it listed the symptoms and said have you had any today. She was kind of fatigued today (10Feb2021). A week later she had pretty serious muscle aches and one more thing. The diarrhea was one massive one this morning and it got rid of everything. It was liquid. She has not had one since. Projectile vomiting was twice within 10 minutes of each other. It happened pretty fast at 09:30-10:00 this morning. She has not eaten anything at all. Muscle aches started at 10:00. The tiredness started before diarrhea and was progressively getting worse. Headache started an hour to hour and a half ago. Chills started at 08:00 and were worse for 2 hours and then got better. She could take off gloves and scarf around her neck but does not have chills now. Outcome of the events massive diarrhea, projectile vomiting and chills was reported as recovering. Outcome of the events fever, pretty serious muscle aches, tiredness and headache was reported as not recovered.

Vomiting and diarrhea two hours after shot. Foggy head for 4 days. Severe joint pain for for 3 days. All ended 04/02/21 except for fatigue which has been ongoing.

she was bleeding (from the eyebrow, it broke a little bit); been laying in bed, is weak, doesn't want to get up; she does not help herself as if she had no movement in her body; Doesn't want to eat; fell a couple of times from bed and chair; she hit her eyebrow and broke it a little bit; Weakness; This is a spontaneous report from a contactable consumer reported for a patient (his wife). A 79-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration on 25Mar2021 10:00 and first dose received on 4Mar2021 ( LOT:EN6201) both as single dose for COVID-19 immunization. Medical history included dementia. The patient's concomitant medications were not reported. Patient received her first dose within 4 weeks prior to vaccination. Patient experienced bleeding (from the eyebrow, it broke a little bit) on 25Mar2021, fell a couple of times and doesn't want to eat. On 26-MAR-2021, Patient been lying in bed, weak, doesn't want to get up, Patient was fell out of bed and she does not help herself as if she had no movement in her body. The outcome of the events she was bleeding (from the eyebrow, it broke a little bit) was unknown and the outcome of the other events was not recovered. Follow-Up (29Mar2021): New information from a contactable consumer followed: Clinical information included new events, outcome details and historical vaccine.

about 3 inches below site she had a rash/rash was about 3 inches below the injection site; below site she had a rash, It was still red; below site she had a rash, swollen, little bit of swelling; below site she had a rash, it was still little sore to touch; below site she had a rash, itchy; Second day I was still tired; had no appetite; Extreme tiredness; chilling; Small fever of 100.5; dull headache; Slept for about 12 hours; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 28Mar2021 at age of 79-year-old (Lot Number: EN6208) at single dose for COVID-19 immunization. Medical history included a little bit asthma, pine allergy, oak allergy, food allergy, 'blood pressure', stroke. Concomitant medications included losartan taken for blood pressure; hydrochlorothiazide taken for blood pressure; omeprazole; fluticasone taken for allergy; acetylsalicylic acid (BABY ASPIRIN); vitamins. The first shot she had, she ended up with a small bruise about the size of a quarter but she did not have any bruise with the second shot. The patient just wanted to report the side effects from the second Pfizer COVID-19 vaccination. She received the second one in the afternoon on 28Mar2021. And on 29Mar2021, just a little less than 24 hours later, it was at about 13:30, she got hit with extreme tiredness and she got in the recliner and got a little blanket and then she started chilling. She did not have the shakes but she couldn't get warm. She ran a small fever of 100.5 and this was for about 4 hours. And she had a dull headache. She slept for about 12 hours out of 16 that day on 29Mar2021. And then, the second day on 30Mar2021 she was still tired and had no appetite and the third day on 31Mar2021 about 3 inches below site she had a rash, swollen and itchy and 01Apr2021 was the fourth day, but it was still sore. The swelling was way down but the rash was still there and it is still itchy. She did take paracetamol (TYLENOL) that first day for the headache and chills. The paracetamol she took was two of them and they were 8 hour arthritic dosage. When paraphrased the concern, the patient stated the rash was about 3 inches below the injection site. It was still red, little sore to the touch, most of swelling down and there was little bit of swelling and red and it had gone down on 01Apr2021. Treatment for events included paracetamol and she had laid down and slept. The outcome of rash, swollen, sore below the injection site were resolving, the red and itchy below injection site was not resolved, the outcome of other events were unknown. No follow-up attempts are needed. No further information is expected.

immediate headache; extreme tiredness; dizziness; nausea; This is a spontaneous report from a contactable consumer (patient, self-reported). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry were not provided), via an unspecified route of administration, in right arm, on 06Feb2021 at 01:00 AM, as a single dose for COVID-19 immunization. Patient did not receive other vaccines within 4 weeks prior to COVID vaccination. Patient's medical history included known allergy. Patient received unspecified medications within 2 weeks of vaccination. It was reported that on 06Feb2021 at 01:00 AM, the patient experienced immediate headache followed by extreme tiredness, and dizziness. Patient also had nausea after 3 days which lasted several days. Patient did not have COVID-19 prior vaccination and since the vaccination, the patient was not tested for COVID-19. No treatment was given to the patient for the events. Outcome of the events was recovered on an unknown date in Feb2021. Information on the lot/batch number has been requested.

Pneumonia; got Covid; doesn't have her appetite back; still kind of shaky/was trembling and shaking; lives with her niece and she found her in between china cabinet and fireplace and asked her how long she been there and she didn't know/going to the bathroom on herself and she doesn't recall that; This is a spontaneous report from a contactable consumer (reported for herself). This 79-year-old female patient received her first dose of the BNT162B2 (Pfizer covid vaccine, Lot number: ER2613 expiry date: unknown) via an unspecified route at left arm as a single dose on 23Mar2021 11:00, for Covid-19 immunization. Medical history included diabetic, cholesterol, acid reflux; had a reaction to tetramycin: she had shortness of breath, sweating, and light headed-ness, 30 years prior to this report. She stated that it was a form of penicillin and they didn't have penicillin so they gave her something else. Concomitant medications included metformin(METFORMIN) for diabetic, fexofenadine hydrochloride (ALLEGRA) and ibandronate sodium (BONIVA). It was reported that she skipped Boniva, that she usually would take at the end of the month. On 25Mar2021, two days after first dose, she got covid and pneumonia . She visited emergency room and was admitted in the hospital from 26Mar2021 till 05Apr2021. The patient did not have her appetite back, felt still kind of shaky, and was trembling and shaking. She did not remember what happened on the 24Mar2021 and 25Mar2021. It was stated that she was improving but she was not back to par. she was not trembling. She stated that she was not fully recovered. She was scheduled for her second dose in 2 weeks on 13Apr2021. It was stated that she had got a list of concomitant medications she was taking (unspecified names) and she did not think any of them would have interacted with this and she was taking them way before she got the Covid shot, also stated that she did not think she had bad underlying issues. The patient had her blood sugar checked and was given her insulin because of Covid and something else. She did not receive any additional vaccines on same date of the Pfizer Suspect or prior vaccinations (within 4 weeks). The patient did not have any Antipyretic (around the date(s) of Vaccination). The patient was recovering from the event of Pneumonia. The outcome of the events of doesn't have her appetite back and shaky/was trembling and shaking was not recovered, however the outcome of the events of Covid and did not remember what happened on the 24Mar2021 and 25Mar2021 was unknown. No further information was provided.

Exhaustion, fever/chills, upset stomach, headache - may have triggered fib - afib led to ICU on 4/22/2021.

1st day: sleepy; 2nd day: some achiness at injection sight; 2nd day: some achiness at injection sight and body; 3rd day: occasional light diarrhea; discomfort; This is a spontaneous report from a contactable consumer or other non-HCP (Patient herself). A 79-year-old female (not pregnant) patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200, Expiration date: Not reported) via an unspecified route of administration in the left arm on 18Feb2021 09:45 as SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (OMEPRAZOLE) and paracetamol (TYLENOL 8 HOUR). The patient experienced on 18Feb2021 13:00; 1st day: sleepy, 2nd day: some achiness at injection sight and body, 3rd day: occasional light diarrhea, discomfort. The patient was not tested for COVID-19 prior to vaccination and after vaccination. The patient has not received any other vaccine within four weeks. The patient was treated with Tylenol and Pepto-Bismol. The outcome of the events was recovering.

excruciating cramps in stomach; numbness in hands; numbness in arms; This is a spontaneous report from a contactable consumer (patient, self-reported). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in Right arm on 06Feb2021 as SINGLE DOSE for COVID-19 immunization. Medical history included diabetes mellitus from 2000 and ongoing Verbatim: Diabetes. Concomitant medications included metformin taken for diabetes mellitus from 2000 and ongoing insulin glargine (LANTUS) taken for diabetes mellitus from 2011 and ongoing. On Feb2021 the patient experienced numbness in hands, numbness in arms and on 24Feb2021 when she was in the kitchen she had excruciating cramps in her stomach. The patient would receive the second dose this Saturday. The clinical outcome of the events was not recovered except excruciating cramps in stomach was recovered on 24Feb2021.

hallucinations; Headache; chills; fever; sweats; diarrhea; got ill/not feeling well; Pain behind eyes and neck and shoulders; Pain behind eyes and neck and shoulders; Pain behind eyes and neck and shoulders; muscle pain; vomiting; she got the 2nd dose of the vaccine last 02Apr2021, she got the first vaccine last 24Mar2021; she got the 2nd dose of the vaccine last 02Apr2021, she got the first vaccine last 24Mar2021; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 79-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Apr2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 24Mar2021. On 02Apr2021, the patient experienced hallucinations, headache, chills, fever, sweats, diarrhea, got ill, pain behind eyes and neck and shoulders, muscle pain, and vomiting. The patient was hospitalized for all events for 4 days. The patient further stated that after 3 hours getting the vaccine she experienced a terrible adverse event like headache, muscle pain, diarrhea, vomiting and chills, she contacted her doctor and she was advised to call the ambulance and go to the hospital but since she was designated next to the isolation of COVID patients she decided to go home after getting the saline that will help her to increase the potassium, she mentioned that until now she was experiencing hallucinations and severe headache and she was not feeling well. The patient also stated that she got the first vaccine last 24Mar2021 (less than 21 days interval). The patient mentioned that she had taken diarrhea medications and antibiotics after the 2nd dose. Therapeutic measures were taken as a result of hallucinations, headache, sweats, diarrhea, got ill, pain behind eyes and neck and shoulders, muscle pain, and vomiting. The outcome of all events was unknown. Information on lot number/batch number has been requested.

Patient is a 79 y.o. female with a history of CAD, COPD, chronic CHF, DM2, HTN who presented to hospital 4/14/2021 with chest pain, upper abdominal pain and ongoing melena. 1. Melena: Ongoing for 6 weeks per patient. Underwent colonoscopy 4/7/21 with polypectomy, no inflammation or bleeding. CT A/P 4/14/21 with mild esophagitis, mild colitis, no other acute finding. IV PPI BID. GI followed, pt is s/p EGD 4/15/21 with normal esophagus, large hiatal hernia with multiple Cameron ulcers and erosive gastropathy with no stigmata of recent bleeding. Biopsied. H&H stable at discharge. Avoid NSAIDs. Discharged on PPI 2. Colitis: Mild on CT A/P. Stool PCR discontinued as diarrhea resolved. Patient is s/p cipro/flagyl in ED. Transitioned to Unasyn with end date 4/15/21. 3. Acute Blood Loss Anemia: Baseline Hgb ~ 12-14. Down to 5.8 on admit in setting of GI bleed. Transfused 1 unit pRBC 4/14/21. Trend H/H Q6H. Transfuse for Hgb < 8 given cardiac diease. Iron studies with evidence of iron deficiency. s/p IV iron. H&H stable at discharge 4. AKI: Baseline creat ~ 0.7-0.8. Elevated to 1.35 in the setting of bleeding/anemia. Held ACEi and diuretic. She did receive IV contrast. Colloid resuscitation with blood transfusion. Resolved 5. Chest Pain w/ Elevated Troponin: Troponin T 16 on admit in setting of severe anemia and poor clearance with AKI. ECG non acute on admit. CT PA negative 4/14/21. Suspect demand ischemia. Negative delta troponin. No further workup. 6. Hx COVID 19: Positive testing 12/2020. Repeat testing ordered in ED 4/14/21 and remains positive. She desaturated only after receiving IV fentanyl in ED. Asymptomatic, CT chest 4/14/21 without GGO. Given > 90 day, patient remain in isolation per OhioHealth Policy. 7. CAD: LHC 9/28 with diffuse disease DES to OM1 and BMS to Circ/OM1. Held ASA/Plavix on admit due to GIB, resumed at discharge. Continued home statin, imdur, BB. 8. Chronic HFrEF: due to ischemic cardiomyopathy. LV 45% on LHC. Continued BB, Imdur. ACEi and Maxzide held initially with GIB and hypotension. PCP follow up 9. HTN: Soft BP on 4/15/21. Continued Imdur and BB with hold parameters. Norvasc, Maxzide, and ACEi discontinued at discharge. Follow up with PCP 10. IDDM2: A1c 7.8% on 3/2021. Continued home regimen. 11. Essential tremor: Follows with Dr. (Neurology). Continued home Propranolol. 12. Pulmonary Nodule: Ct chest 4/14/21 with 6mm pulmonary nodule, repeat in 6-12 moths.

patient felt lightheaded and nauseous suddenly on the morning after the 2nd covid vaccine. she tried to lower herself to the floor, but blacked out and hit her head, requiring staples. she is still experiencing extreme fatigue, which is unusual for her. she is highly functional at baseline.

This 79 year old female received the Covid shot on 2/18 and went to the ED on 2/26 and was admitted on 2/26 with chest pain and abdominal pain and again to the ED on 3/14 and admitted on 3/14 with hyperkalemia, acute renal injury, chest pain and died on 05/04/21 . 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.

Lightheaded and dizzy; Nauseous; Dehydrated; Lightheaded and dizzy; Atrial fibrillation with rapid ventricular response; Not feeling well; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 at the age of 79 years old, (Batch/Lot Number: EW0164) as SINGLE DOSE for covid-19 immunisation, and dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 Batch/Lot number was E or F, N6205;) as a single dose, for covid-19 immunisation. Medical history included diabetes from 2009, coronary artery disease from Jan2020, and atrial fibrillation and Shingrix Vaccine/NDC, Lot Number, Expiration Date not known by caller.Vaccination Date: Jul2018. Concomitant medications were not reported. On 17Apr2021, the patient reported not feeling well. 18Apr2021 she woke up in the morning and was lightheaded and dizzy. She was also nauseous.States she called an ambulance. She was found to be in Atrial Fibrillation. she also found out when she got to the Emergency Room that she was dehydrated. States she does not know if that ties in with the vaccine or not. She states someone told her she should be drinking a lot of water since she had the vaccines; asks if this is true. She was admitted to the hospital on Sunday 18Apr2021 and was released yesterday afternoon 20Apr2021.On 19Apr2021, she was lightheaded and dizzy, nauseous. She also experienced atrial fibrillation with rapid ventricular response and was dehydrated. The patient was admitted to the hospital on 18Apr2021 and released on 20Apr2021. The outcome of the events of not feeling well, lightheaded and dizzy, nauseous were recovered on 20Apr2021, the remaining events was unknown. .

vary sore arm; pain in part of the neck; bad headache; Injection site swelling; Injection site redness; Nervousness; Feeling unwell; Arm pain; Vomiting; Her neck hurts; Her hurting shoulder; This is a spontaneous report from contactable consumer. A 79-years old contactable female consumer (patient) reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EW2171), via an unspecified route of administration on 27Apr2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on 27Mar2021 for covid-19 immunization (first dose and lot number- ER8732). On an unknown date, the patient experienced very sore arm, pain in part of the neck, bad headache, injection site swelling, injection site redness, nervousness, feeling unwell, arm pain and vomiting. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Arrival Date: 2/14/2021 Discharge Date: 2/18/2021 Primary Discharge Diagnosis: Principal Problem: Sepsis (HCC) POA: Yes Active Problems: GERD (gastroesophageal reflux disease) POA: Yes Portal hypertension (HCC) POA: Yes Thrombocytopenia (HCC) POA: Yes Esophageal varices (HCC) POA: Yes Chronic systolic heart failure (HCC) POA: Yes Essential hypertension POA: Yes Hyperlipidemia POA: Yes Operations/Procedures: None Pertinent Diagnostic Studies: Xr Chest 1 View-portable Result Date: 2/15/2021 Portable chest at 0039 hours HISTORY: New left internal jugular catheter. AP sitting portable chest compared to February 14, 2021 and shows introduction of a left internal jugular catheter with the tip doubled back on itself possibly in the distal brachiocephalic vein. No evidence of pneumothorax. There is a coarse appearance to the pulmonary interstitium bilaterally some of which may reflect chronic disease though the possibility of a very small infiltrate at the left base retrocardiac cannot be excluded and has not changed. No significant pleural effusion or definite acute vascular congestion. The heart, mediastinal and hilar structures are not enlarged or changed. Degenerative disease of the spine is noted with a mid thoracic scoliosis convexity to the right. Left internal jugular catheter in place with distal tip curved back on itself possibly in the distal brachiocephalic vein. Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Xr Chest 1 View-portable Result Date: 2/14/2021 PROCEDURE: XR CHEST 1 VIEW-PORTABLE HISTORY: cough COMPARISON: 9/27/2020 Impression: Limited portable view obtained. Heart mediastinum stable There is mild central vascular and interstitial prominence which could reflect developing mild interstitial edema or interstitial pneumonitis. No severe CHF. Some slightly more focal patchy increased interstitial airspace opacity in the left lower lobe retrocardiac region is identified and could represent a developing infectious inflammatory infiltrate. Clinical correlation and follow-up advised Incidental findings: CXR- Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Test Results Pending at Discharge: Pending Labs Order Current Status Microscopic Urinalysis In process Blood Culture Peripheral Preliminary result Blood Culture Peripheral Preliminary result Active Issues Requiring Follow-up: ISSUE- Needs to follow up with PCP Discharge Medications: Discharge Medications New Medications Sig cefpodoxime 200 MG tablet Commonly known as: VANTIN Start taking on: February 19, 2021 Take 1 tablet (200 mg total) by mouth daily. Do not start before February 19, 2021. Quantity: 6 tablet Discharge Disposition: Home Or Self Care Code Status: DNR Details of Hospital Stay History of Present Illness (from the H&P) CHIEF COMPLAINT: Chills fever, nausea, vomiting, diarrhea after receiving Covid vaccine #2 (Pfizer) HPI: This is a 79 y.o. female with a past medical and surgical history as below-most significant for breast cancer that was diagnosed in 2017, portal hypertension secondary to fatty liver in 2019, resultant esophageal varices that bleed presents with the following chronological history: Approximately 9 AM yesterday morning she went to the clinic for her second Covid vaccination. At that time her temperature was 97.3. She felt fine the rest the day. At 1 AM she woke up with shakes. She continued with nausea and that resulted in vomiting and then diarrhea. She also had severe pain in her thighs. This was severe enough that she called the ambulance. Patient also relates later that she had had some burning on urination 2 days prior to the vaccination. She had leftover Macrodantin that she took 9 PM yesterday. Also relates back in December she was seen by Dr for vaginal infection and 2 times a week she has to administer intravaginal antibiotics. She has had multiple GI bleeds secondary to esophageal varices and is followed regularly by Dr who has had to do multiple banding procedures on her. She also relates she has an enlarged spleen and is followed by Dr. In the emergency room she was noted to be febrile and hypotensive. She received a total of 5 L of normal saline in the ER to bring her pressures up with a systolic below 100. She has a very elevated procalcitonin as well as lactic acid. Urine is positive for large amount of blood and small leukocyte esterase Hospital Course 79 y.o. year old female with HTN, infiltrating ductal carcinoma of the right breast stage I status post lumpectomy with positive margins was on anastrozole but taken off secondary to abnormal liver enzyme testing, CLL/thrombocytopenia stage I with no treatment needed, fatty liver complicated by portal hypertension/splenomegaly resulting in bleeding esophageal varices, history of viral cardiomyopathy in 2006, B12 deficiency, history of admission for septic shock, chronic diarhea, presented to the emergency room on 2/14 complaining of fevers, myalgias fatigue nausea and vomiting 24 hours after having a second dose of COVID-19 vaccine. She was admitted for septic work-up and later found to be hypotensive after 7L of fluids and was transferred to the ICU for septic shock, left IJ was placed. Source of infection found to be septic from UTI. Urine culture sterile with less than 1000 colony forming units and blood cultures no growth to date. On the day of discharge. Shock resolved. Her procalcitonin trended down. Wonder whether she had an exaggerated response to the Covid vaccine given that today the urine culture shows no growth. Regarding acute on chronic diarrhea she had unremarkable GI PCR and diarrhea improved after starting Imodium. She is had extensive work-up for this with GI as outpatient and days colonoscopy planned in the near future. CLL with splenomegaly/nodular hyperplasia of the liver with noncirrhotic portal hypertension/neutropenia/thrombocytopenia/hyperbilirubinemia/esophageal varices requiring banding in the past -Was restarted on propanolol and midodrine prior to discharge. -Chronic stable anemia/B12 deficiency-getting supplementation every 3 months Thrombocytopenia -she did have drop in platelet counts during admission while being on pantoprazole and Lovenox and these were discontinued and platelet count stabilized. She can have repeat CBC as outpatient to document improvement in platelet count. She was not noted to have any platelet type bleeding. History of right-sided breast cancer status post lumpectomy was on anastrozole but stopped secondary to liver disease Lab Studies: Lab Results Component Value Date GLUC 86 02/18/2021 CALCIUM 8.4 (L) 02/18/2021 NA 149 (H) 02/18/2021 K 3.8 02/18/2021 CO2 23 02/18/2021 CL 114 (H) 02/18/2021 BUN 18 02/18/2021 CREAT 0.9 02/18/2021 Results from last 7 days Lab Units 02/16/21 0702 MAGNESIUM mg/dL 1.9 Lab Results Component Value Date CALCIUM 8.4 (L) 02/18/2021 PHOS 2.4 (L) 02/17/2021 Results from last 7 days Lab Units 02/18/21 0724 02/14/21 1855 WHITE BLOOD CELL COUNT Thou/uL 4.1 < > 2.9* HEMOGLOBIN g/dL 10.0* < > 8.8* HEMATOCRIT % 30.0* < > 27.7* PLATELET COUNT Thou/uL 33* < > 37* NEUTROS PCT % -- -- 84.7 NEUTROS ABS Thou/uL -- -- 2.40 LYMPHS PCT % -- -- 10.9 LYMPHS ABS Thou/uL -- -- 0.30* MONOS PCT % -- -- 3.1 MONOS ABS Thou/uL -- -- 0.10* EOS PCT % -- -- 0.8 EOS ABS Thou/uL -- -- 0.00 BASOS PCT % -- -- 0.5 BASOS ABS Thou/uL -- -- 0.00 < > = values in this interval not displayed. Lab Results Component Value Date ALT 28 02/18/2021 AST 15 02/18/2021 GGT 22 09/09/2019 ALKPHOS 116 02/18/2021 BILITOT 1.0 02/18/2021 Physical Exam at Discharge Last Vitals: BP 117/70 (BP Location: Left arm, Patient Position: Lying) | Pulse 73 | Temp 98.1 °F (36.7 °C) (Tympanic) | Resp 18 | Ht 1.626 m (5' 4") | Wt 73.2 kg (161 lb 6 oz) | SpO2 94% | BMI 27.70 kg/m² Patient was seen and examined by me on the date of discharge. General Appearance: Alert, Awake, not in acute distress. Cardiovascular: S1-S2 regular, no murmurs present. Respiratory: Bilateral air entry present, no added sounds heard Gastrointestinal: soft, non-tender, non-distended, bowel sounds present. Extremities: B/l LE edema I spoke with the patient regarding the discharge plan. The discharge plan was discussed with the case management and the nursing staff. Patient verbalzied understanding of the discharge and was agreeable for the discharge plan. Called pt;s husband to give update on care plan but got voice mail. Condition on Discharge: Improved

ED Discharged 4/4/2021 (2 hours) Hospital ED MD Last attending ? Treatment team Acute cystitis without hematuria +1 more Clinical impression Sore Throat ? Fever ? Back Pain Chief complaint ED Provider Notes MD (Physician) ? ? Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with ? Sore Throat ? Fever ? Back Pain 80-year-old female with multiple complaints. Patient states she had her second Covid vaccine yesterday. Since then she is complaining of having generalized weakness, headache, body aches, back pain, cough, nausea, generalized weakness and dizziness. No abdominal pain. She has nausea but no vomiting or diarrhea. No dysuria. Denies any chest pain.

tired; cold; head was in a fog; Staggering; Diarrhea; ears were ringing; arm was sore; body ache; neck was painful; back of head pain; This is a spontaneous report from a contactable consumer (Patient). A 79-year old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140, Expiration Date Mar2021) into the left arm on 11Feb2021 at 4:00pm (at the age of 79-years-old) at single dose for COVID-19 immunization. Concomitant drugs included ciclosporin (RESTASIS) twice daily both eyes taken for dry eye; bimatoprost (LUMIGAN) one daily both eyes taken for glaucoma for 5-6 years, vitamin B complex 1 daily taken as supplement for 15-20 years; colecalciferol (D3) 2 daily during the winter and 1 daily in the summer taken as supplement for 3-4 years. She use to get a lot of sore throats. Her doctor suggested she take vitamins. Some that she took didn't help. On 11Feb2021 the patient experienced arm was sore not recovered, body ache recovered on 13Feb2021 and on 12Feb2021 she experienced tired recovered on 13Feb2021, cold recovered on 12Feb2021, head was in a fog not recovered, staggering recovered on 13Feb2021, ears were ringing recovered on 13Feb2021, Diarrhea recovered on 12Feb2021. Further reported the back of her head and neck was painful that was gone by 13Feb2021. Her arm was sore if she lays on it she can feel it. Unable to answer outcome of event for being tired,if she sits long enough she falls asleep. Her head still feels tender. She is no longer staggering. She feels comfortable going up and down stairs. The next dose is scheduled for 04Mar2021. She is considering not taking the second dose.

red blood bleeding; gastrointestinal upset; diarrhea; chills; headache; This is a spontaneous report from a contactable consumer(patient). A 79-year-old female patient received first dose of bnt162b2(BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date (at the age of 79-years-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that, after the first dose of the vaccine she had side effects that included red blood bleeding during the 3-4 days that she had gastrointestinal upset, diarrhea, chills, and headache. The patient stated, the bleeding stopped, and she was doing better now but she was just upset and concerned with the bleeding. She did not know if she should receive the second dose. She would like to know should she receive the second dose after having this side effect. The Pfizer team responded as the patient should not get the Pfizer-BioNTech COVID-19 Vaccine if patient had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. The Pfizer team referred patient to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The outcome of the events red blood bleeding was recovering, and the outcome of the events gastrointestinal upset, diarrhea, chills, and headache was unknown. Information on the lot/batch number has been requested. Information on the lot/batch number has been requested.

sleepy and wanting to sleep all day; Chills; fever; weak; no appetite; fatigue; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9267), via an unspecified route of administration, administered in right arm on 22Feb2021 12:00 (at the age of 79-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, acid reflux and shell fish allergy. The patient's concomitant medications were not reported. On 24Feb2021 at 12:00 chills, fever, no appetite, weak, fatigue, sleepy and wanting to sleep all day. The patient did not receive any treatment for the events. The patient did not have COVID prior vaccination. She was not COVID tested post vaccination. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever.; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick; taste problems; I thought maybe I had this COVID because I was sick; feeling a little chilly; This is a spontaneous report from a contactable other health care professional. A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6198) at the vaccination age of 79-year via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. Patient historical vaccine includes first dose of BNT162B2; LOT number: EL9269 ,which was administered on 12Feb2021 for COVID-19 immunization. Medical history included neuropathy peripheral and hypertension. Concomitant medications included, lisinopril taken for hypertension, gabapentin taken for neuropathy peripheral, levothyroxine and dicyclomine. On an unspecified date, the patient experienced I thought maybe I had this covid because I was sick; I had the taste problems and the doctor lately did a test on me to see if I still have the antibodies and I did not. so, he said no, it does not look like you had it; a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick and taste problems. On 05Mar2021 09:00 PM patient was feeling a little chilly. On an unspecified date the patient underwent lab tests and procedures which included blood thyroid stimulating hormone: unknown results, sars-cov-2 test: negative. The seriousness of all the event was reported as non-serious. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information expected.

no strength at all in her legs and her arms, muscles didn't work at all; Nauseas; Temperature of 100.6 degrees; Headache; her joints swelled; her hands were swollen and tight; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), an unspecified route of administration, administered in Arm Right on 25Feb2021 at 10:30 (Batch/Lot Number: EL9267) as 1st dose, single for covid-19 immunization.Concomitant medication(s) included warfarin sodium (COUMADIN), she takes a 5mg tablet, by mouth, once daily on tuesday, thursday and saturday's. The rest of the days she takes a half of a 5mg tablet confirmed as a 2.5mg dose, by mouth once daily. Indication: She had 2 strokes about 12 years ago, so it keeps her blood regulated, not too thick or too thin, usually it's right on. When probed for any product information, the caller made the comment let her get in some light so she can see better. She confirms the bottle is dispensed in a pinky peach pharmacy vial. She sees an Rx number, Use by date: 26Jan2022 and losartan potassium (COZAAR) taken for blood pressure measurement was the generic for Cozaar, Losartan potassium. She takes a 25mg, tablet, by mouth, once daily for her blood pressure. She verifies this medication is also dispensed in a pharmacy bottle. She mentioned she takes both medications, Coumadin and the Losartan potassium, at night time because it's easier for her to remember. The patient stated she takes a blood pressure medication and a coumadin tablet, She clarifies she has been on these medications for a long time, more than the 2 week time period leading up to receiving the COVID-19 vaccine. She went to bed early on Friday night, 26Feb2021, because she had issues all day long and she forgot to take these medications. She only takes 2 pills at night but she forgot all about them because she had all that stuff going on during the day. o prior vaccinations within 4 weeks. Medical history included cerebrovascular accident (She had 2 strokes about 12 years ago). O 25Feb2021, the patient experienced headache and on 26Feb2021, the patient had asthenia, nausea , pyrexia (temperature was 100.6 degrees), joint swelling and peripheral swelling. It was reported that patient had a really crazy experience, She received her first dose on 25Feb2021 at around 10:30 am afterwards, she had just a regular headache and then the next morning, she tried to get out of bed and had no strength at all in her legs and her arms. She got up out of bed, and her legs would not hold her up so she collapsed on the floor. She mentions her husband is hard of hearing and she was calling for his name to help her. She could not even scoot on the floor, her muscles just did not work at all. The caller states her husband came in and got her up. She went to the bathroom and then for the rest of the day, she stayed in the recliner. Really, the next day, she got back her strength in her shoulders. She clarifies on Saturday, 27Feb2021, she started to get back her strength. She also read in the newspaper to not get a mammogram and a COVID-19 vaccine on the day and she did because they didn't know. She confirms her mammogram was scheduled on 25Feb2021 at 2pm, which was after when she received the COVID-19 vaccine, so her mammogram might not be right. The outcome of events recovered on 27Feb2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

She got her vaccine, she had no symptoms. The following day had very little soreness and nothing else. Went to bed, woke up soaking wet, diarrhea, vomiting, dizzy. She did not have skin feeling funny like with regular flu, but mostly all intestinal. She changed her clothes and then was shivering and could not get warm, and had hard shaking chills. She slept very little and has had it continuous since the vaccine. She has been falling a sleep a lot, day, night and was previously very active and now falls asleep at a drop of a hat. Over the past week and a half has had the cold chills less, but has awakened moist. She is having the diarrhea and GI issues less, but feels nauseous at times during the day. She is still waking up between 11:00 and 2:00 waking up, but falls sleep a lot, does not have a regular schedule as she did before. It is not debilitating as much but still tired a lot.

nauseous; couldn't sit up; spinning; This is a spontaneous report from a contactable consumer. A 79-year-old female consumer (Patient) reported that she started to receive BNT162B2 (BNT162B2, formulation: Solution for injection, vaccinated at the age of 79-year-old) via unknown route of administration from 21Jan2021 16:00 to 21Jan2021 16:00 at single dose daily for covid-19 immunization. Patient's medical history was reported that, I have allergy to penicillin and sulfur but this was 50 years. Felt like my throat and ears were closing. Concomitant medications were not reported. It was reported that caller she received the first dose of the Pfizer vaccination on 21Jan2021 at around 4 in the afternoon. She had a bad reaction. She drove 1 hour and 45 minutes away and she was fine that night. Caller stated, "The next morning, I was nauseous. I couldn't sit up. I had to call my daughter to help me sit up. When I tried to sit up. it was like it was I had to push (myself and my daughter) up a mountain in a tornado. I couldn't control my body even if you tried. It was a very severe reaction if not vertigo. It was awful. spinning widely, nauseous. I called the doctor and he prescribed some vertigo medication/nausea medication. We tried an Epley maneuver for vertigo. spinning uncontrollably. which ear it was in. did the epley maneuver itself. I couldn't bend down. The last week or so I've been cautious but ok, tried to seen ENT and I have a therapist to help me do that Epley maneuver again. I don't want to set off anything. I don't know if you had any reports of any like that? I'm due to get my next shot 11Feb2021 and I have to drive 2 hours again and will have to drive home again. I'm most concerned and my doctor feels I need to get the second dose too. I reported to VAERS. The outcome of events was "unknown". Information on lot/ Batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

I had pain on the left side of my head above the ear; I was freezing; had terrible chills; completely exhausted; My stomach hurt; couldn't eat; lost 2 1/2 lbs; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6198, Expiration Date: not reported) via an unspecified route of administration in left arm on 05Mar2021 at 13:30 (at the age of 79-year-old) as a single dose for COVID-19 immunization at pharmacy or Drug Store. Medical history included an unspecified allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included atenolol at a dose of 50 mg twice daily, received in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number PAA156051, Expiration Date: not reported), via an unspecified route of administration, in right arm on 10Feb2021 at a single dose for COVID-19 immunization and experienced very tired for over a day. On 05Mar2021 after the second shot at 18:30 (reported as within 6 hrs), the patient experienced pain on the left side of her head above the ear and was freezing, had terrible chills for 2-3 hrs and had to be covered with several blankets. Patient did warm up, but completely exhausted into Sunday AM (as per report), her stomach was hurt, couldn't eat and patient lost 2 1/2 lbs. Patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Depressed/depression; It has caused diarrhea that has persisted for 8 weeks; Soreness/her shoulder was sore; This is spontaneous report received from a contactable consumer (patient sister, Caregiver). This is report 1 of 2. This report is in regard to the reporter's sister. A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown, NDC number: Unknown, Expiry Date: Unknown), via unspecified route of administration on an unspecified date (about two months ago) as 2nd dose single for covid-19 immunization. The patient had History with Oral lichen planus From an Unspecified date and unknown if ongoing). Concomitant medications were not reported. Patient did not have any other product. Reporter stated that, she doesn't know the specific day of vaccination. It has caused diarrhea to the patient that has persisted for 8 weeks. GI doc gave Lomotil, and it helped a little bit. She has had to change her diet and cut out vegetables because it made the diarrhea worse. Patient was very depressed. Patient wanted to know if It was reported earlier and why would it cause the ongoing diarrhea. Patient had seen that that it causes sometimes severe diarrhea, but it didn't say how long it will last. Patient was concerning about if someone need to take an immunosuppressive medication to stop the diarrhea. She was afraid her doctor is going to tell her she needs to take an immunosuppressant medication. It also had stated like, if the Pfizer aware that people have to take medications that shut down the immune system. Upon follow up on 27May2021, reporter stated that, patient was very depressed (on unspecified date) about it. She had a tendency of having autoimmune problems, that she had oral lichen planus, sometimes called burning mouth syndrome. Her doctor diagnosed her with oral lichen planus, which is an autoimmune reaction to bell peppers, she was eating a lot of bell peppers. patient has a hyper immune system. She did not take any type of autoimmune medications no Humira or immunosuppressive medications. Patient took the COVID-19 vaccine 8 weeks ago and patient developed the diarrhea by the 4th day after the vaccine. Patient had never had diarrhea her entire life. Patient went into shock. Her sister's diarrhea was still ongoing. The gastro doctor gave her sister Lomotil and the Lomotil was working to a point, it prevents the worst of the diarrhea. Her stool was coming out very loose. Reporter did not have the NDC number, lot number and expiry date for the Lomotil, stating it was a prescription, chemical name called atropine or something (as reporter). Patient changed her diet and was becoming depressed. Normally, her sister is a person very concerned for her health and she would have a plant-based diet with multiple vegetables, and now her sister can't do that. patient felt her life depends on having a healthy diet. Patient had vaccinated at pharmacy or something, reporter was concerned that, patient got a good vaccination that was not corrupt in any way. Reporter was urging patient to get the vaccine because she travels and goes to a different country and this and that. So, she could be able to travel. patient has a hyperactive immune system, it appears so anyway. Reporter was using her own words when she uses the term hyperactive immune system, so this may not be medically accurate. Her sister has oral lichen planus which is a bad problem. patient was eating a lot of bell peppers. Bell peppers produce an immune reaction, because they contain a chemical called solanine. patient was eating a lot of bell peppers because the internet said they were healthy and contained a lot of vitamin A. she got an immune reaction to the bell peppers, and the immune reaction produced sores under her sister's tongue, very painful sores. Patient had side effects happen three or four days later after the vaccine- it started as diarrhea and she thought it would stop. Patient's shoulder was sore. reporter mentioned she doesn't know when patient's soreness began and ended. The soreness did completely go away for patient. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Event Did not require any visit to emergency Room or Physician Office. Prior Vaccinations within 4 weeks of the suspect vaccine and events following prior vaccinations were none. Patient's Family Medical History was related to the autoimmune stuff, clarified as the oral lichen planus. Patient had oral lichen planus and was previously treated with steroids. The oral lichen planus started with sores under her sister's tongue. Her sister was treated twice with steroids. Patient said the steroids were successful. Patient's sores were treated with a steroid once and then the sore returned so she went back to the same doctor, and the doctor treated her again with steroids. The second time, the sores went away. At that point, this condition was called burning mouth syndrome, which is on the internet, it was a known condition that is very painful. The doctor diagnosed it as burning mouth syndrome. The diarrhea her sister is experiencing was causing a psychological effect. Reporter stated that, there was no warnings of if a person who has an overactive immune system shouldn't take the COVID vaccine, there was no kind of warning. Reporter seriousness for all the events were Unspecified. Outcome of all the events were unknown. Information on the lot/batch number has been requested.

rectal bleeding; sensation/pain in her right arm; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW1051), dose 1 via an unspecified route of administration, administered in Arm on 15May2021 17:30 (at the age of 79years) as 1st dose, single for Covid-19 immunization. Medical history included allergic to lemons, vinegar and white wine, severe reaction to some eye drops 4-5 years ago, vomiting, and diarrhea, rectal bleeding, stomach hurt, and felt like her head was going to explode. The patient's concomitant medications were not reported. The patient reported that she was allergic to lemons, vinegar and white wine and can't take any pills because they make her stomach hurt, she now only takes natural medicines. She had a margarita the week before the vaccine that had some lemon juice in it, and she had rectal bleeding for a few days. She also had a severe reaction to some eye drops 4-5 years ago, she does not know the name of the medication, just that it was a generic. Half an hour after putting it in one eye she said it felt like her head was going to explode and thought she was going to die. The ambulance was called but refused to go in and had her friend take her in. She also experienced vomiting and diarrhea. On 16May2021, the day after the shot (Covid vaccine) she had some rectal bleeding similar to a light period but only for one day. She also had the shot in the left arm but had a sensation/pain in her right arm that went away quickly. The patient was unsure if that happened because she also had 2 margaritas and they made it with lemons which she is allergic to so it might have been that. The patient asked if the vaccine have any vinegar or wine in it. The patient also asked if she could get the second dose of the vaccine if she's had a severe reaction to some eye drops 4-5 years ago. She doesn't remember name of medication but had severe side effects including her head felt like her head was going to explode, vomiting, and diarrhea. The outcome of event rectal bleeding was recovered on 17May2021, while the outcome of event sensation/pain in her right arm was recovered on an unspecified date.

Patient had previously been feeling short of breath for about a month. She received the 2nd Pfizer covid vaccine dose on 6/9 and felt nauseous the next two days. She came to the ED on 6/10 with nausea, vomiting, and lethargy. Found to be hypotensive, bradycardic, and in 3rd degree heart block. Suspect patient was already in heart failure and might have developed myocarditis after receiving the vaccine which could have exacerbated her heart failure.

Two weeks after first shot was dizzy,. One night after second vaccine dizzyness and emesis lasted for one day

Extreme Stomach Pain; Vomiting; Really sick; Nausea; This is a spontaneous report from a contactable consumer (patient's husband). A 79-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) intramuscularly on Wednesday (19May2021) as a single dose in the left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had a COVID-19 test on 29Apr2021 with a result of negative. The patient previously received dose 1 of BNT162B2 on 28Apr2021 for COVID-19 immunization. On 22May2021, the patient experienced extreme stomach, vomiting, and nausea. She was really sick. The patient received treatment with bismuth salicylate (PEPTOBISMOL) 2 tablets to try to stop nausea. The outcomes of extreme stomach pain, vomiting, really sick, and nausea were unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained.

headache; low temperature, temperature was 97 degrees and went up 101 at one point; stomach cramps; bad backache; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: EN5318, expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 22Jan2021 at 16:00-16:30 hours as dose 1, single dose (at the age of 79-years-old) for COVID-19 immunisation. The patient had no medical history and relevant family medical history. There were no concomitant medications or other products used by the patient. Patient had no other vaccinations within four weeks prior to the first administration date of the vaccine. On 24Jan2021 at 07:30 hours, patient had bad backache, stomach cramps and low grade temperature. Patient stated that she was in bed for three days with a bad backache, stomach cramps and low temperature, temperature was 97 degrees and went up 101 at one point. Patient stated that on the information sheet paperwork that it stated that if she had a reaction with that one that she should not get the second vaccine, so patient wanted to know what to do. On 26Jan2021, at 10:00 hours, patient had a headache the last day. Patient took Tylenol, as treatment. Patient had no emergency room and physician office visit. No relevant lab tests were performed. The outcome of all the events was resolved on 26Jan2021. Lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information was expected.

loss of apatite/can't eat anything- everything tastes like soap; diarrhea; fatigue; body aches; difficulty breathing; congestion; feel sick; chills; cough; headache; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported for herself that: A 79-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ENG198, Expiration date: Unknown), via an unspecified route of administration with a needle into left upper arm on 06Mar2021 at 9:30 (at the age of 79-years) as (exact dose unknown) single dose for covid-19 immunization. The patient medial history included ongoing neuropathy pain, ongoing asthma (diagnosed when she was a kid), ongoing bladder problem/bladder infections (she kept getting bladder infections; went to a bladder specialist 6 months prior), ongoing high blood pressure (diagnosed for many years), ongoing arthritis (diagnosed for many years) and knee replacement in 2008. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect, was not administered additional vaccines on the same date of the Pfizer vaccine, and did not receive any prior vaccinations within 4 weeks of Pfizer vaccine. The patient had no family history relevant to the adverse events. Concomitant medications included gabapentin (been taking that for years) from an unspecified date to ongoing for neuropathy pain, losartan potassium (been taking this for years) from an unspecified date to ongoing for high blood pressure, nitrofurantoin (MACRODANTIN) (about 6 months) from an unspecified date to ongoing for bladder infections, beclometasone dipropionate (QVAR REDIHALER) (been taking this for years) from an unspecified date to ongoing for asthma, Serevent Diskus (been taking this for years) from an unspecified date to ongoing for asthma, estradiol vaginal cream usp (about 6 months) for "bladder" (bladder disorder), and ibuprofen (if she needs it, but she doesn't always need it). The patient stated she was taking her usual medications-allergy medications, high blood pressure medicine and estrogen. The patient's historical vaccines included shingles vaccine in 2019 with sore arm as the reaction, pneumonia vaccine in 2019 with sore arm as the reaction and tetanus vaccine in 2019 with sore arm as the reaction. She did not have NDC/LOT/Expiration number of the historical vaccines. On 19Mar2021, the patient began to feel sick. She reported the following symptoms: chills, cough, headache, difficulty breathing and congestion starting on 19Mar2021 around noon time, fatigue and body aches starting on 20Mar2021 gradually throughout the day, and loss of appetite/ "can't eat anything- everything tastes like soap" gradually throughout the day and diarrhea starting on 21Mar2021. She thought it was going away, but it didn't. She stated that when the chills first started, she couldn't even hold her hand still, but that had improved. She stated that everything tasted like soap on the third day of the symptoms' onset on 21Mar2021. She stated that she made herself eat a little, but she just couldn't. She stated that she drank as much water as she could. She stated that the taste of soap was there before, but she didn't recognize it for what it was until it started to get worse. She stated that she needed to get her glasses to read the writing on her vaccination record card. She started that she did not want to get the second dose on Saturday, 27Mar2021. The patient inquired what she should do. She stated that to be able to talk on the phone, she had to take paracetamol (TYLENOL) 650 mg, and she had taken one tablet. The patient did not require emergency room or Physician office visit due to the events. She thought it would go away, so she didn't go see her doctor. Treatment received for the events included paracetamol (TYLENOL) 650 mg. The patient had undergone no investigations or relevant tests. The outcome of the event fatigue and loss of appetite was worsened. The outcome of the events difficulty breathing, body aches and diarrhea was not recovered. The outcome of the event chills, cough, headache and congestion was recovering. The outcome of the event "feel sick" was unknown. No follow-up attempts are possible. No further information is expected.

Diarrhea; This is a spontaneous report from a contactable consumer (reported for herself). A 79-year-old female patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04Feb2021 (at the age of 79-years-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing irritable bowel syndrome (she has had it for years, probably about 30 years ago and it doesn't go away) and ongoing arthritis (she has arthritis so before she goes to bed every night, she takes 2 Advil). Concomitant medication included Advil (2 Advil every night) for arthritis. The reporter stated that, she got first dose on last Thursday, it was her first shot, she was supposed to get the next one in 3 weeks. She was reading on the internet before the day of vaccination at night that if they take Advil, it would reduce the effect of taking the vaccine. The reporter didn't get any information like that when they got the vaccine. She had arthritis so before she goes to bed every night, she takes 2 Advil, does that effect the vaccine and if so what percentage of the efficacy was affected. The reporter said she had another question. Her and her husband both didn't know they shouldn't take headache medicines and her husband gets migraines and the day before the vaccine he took an excedrin and she took advil every night so they both were wondering and also the day after the vaccine, they did not feel bad the first day but the next day they had diarrhea. Caller said she had Irritable bowel syndrome so she sometimes had diarrhea, but her husband never had diarrhea and they both had diarrhea the day after. The reporter stated that the diarrhea was gone now for both of them but in the information the hospital gave with the possible side effects, that wasn't mentioned at all there was a bunch of different things but not diarrhea. The reporter stated that she had IBS but her husband didn't have that was why they thought it may have been the vaccine. She had that problem all the time with IBS so never know if it was with the IBS or not. The outcome of the event was resolved. Description of Product Complaint: Description of complaint: Caller is calling about the Pfizer COVID 19 vaccine she got last Thursday, it was her first shot, she is supposed to get the next one in 3 weeks. She was reading on the internet last night that if they take Advil, it would reduce the effect of taking the vaccine. They didn't get any information like that when they got the vaccine. She has arthritis so before she goes to bed every night, she takes 2 Advil, does that effect the vaccine and if so what percentage of the efficacy is effected. She says she has another question. Her and her husband both didn't know they shouldn't take headache medicines and her husband gets migraines and the day before the vaccine he took an Excedrin and she takes Advil every night so they both were wondering about that. Caller does not have their vaccine record cards with her at the time of the call. She is not able to provide NDC lot expiration for either of their vaccinations. She confirms her and her husband both received the Pfizer COVID 19 vaccine. Product strength and count size dispensed: Additional lot numbers: Is a sample of the product available to be returned, if requested (Y/N): Packaging sealed and intact? Information about lot/batch number has been requested. Follow-up attempts completed. No further information expected.

This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration in arm left on 06Mar2021at 11:00 (at the age of 79-year-old) as single dose for COVID-19 immunization. Medical history of the patient included high blood pressure, sinus issues. Family Medical History included that her daughter has had reaction to medications, she had flu vaccine and she ended up in the emergency department, she had trouble breathing. Concomitant medications included atenolol started a long time ago taken for high blood pressure. Patient previously used clindamycin as in her age she occasionally breaks. Patient previously received flu vaccine in 2009 for immunization and had a reaction. She had the Flu vaccine for many years and the one she had trouble with was a vaccine without preservatives. On 06Mar2021, seven hours after receiving first dose of vaccination, in the evening patient noticed that her mouth started to burn, accidentally pinched her arm and the pain was more than expected and it left a bruise. On 12Mar2021, patient experienced sinus issues. On 20Mar2021, patient experienced that her legs were heavy and felt like they were weighted, which made it difficult for her to walk. On 22Mar2021, patient experienced burning pain on her lower lips, specifically in the space between the lip and the teeth. There was also burning pain in the face, in the arm and her neck-chest area, which caused great mental distress, a huge emotional toll, specifically being upset and devastated, lack of sleep, and weight lost due to lost of appetite with 5 pounds being lost within 2 weeks of these side effects. On an unspecified date in 2021, patient experienced hypersensitivity reaction. Patient stated that when she was changing her outfit she accidentally pinched her arm and the pain was more than expected and it left a bruise. About 7 hours after, she noticed that her mouth started to burn. She mentioned that she also had pineapple that day and was not sure if it was caused by the vaccine. On the 09Mar2021, she consulted a nurse practitioner who said that the burning may have been caused by the Pineapple. On 10Mar2021, she consulted her allergologist and got tested for a pineapple allergy. The results came in on 15Mar2021 and they came back negative for the allergy, but her allergologist mentioned that pineapple can still irritate the mouth. On 18Mar2021, she consulted with her Primary in which she was given magic mouthwash that made it worse. She was made to continue her benadryl and aspirin spray. On 20Mar2021, that Saturday night, as she was walking, she felt that her legs were heavy and felt like they were weighted, which made it difficult for her to walk. It lasted for about 20-30 minutes before subsiding. Last Monday, 22Mar2021 she really started to notice the burning pain on her lower lips, specifically in the space between the lip and the teeth. There was also burning pain in the face, in the arm and her neck-chest area. She described it as not constant but comes and goes. On 25Mar2021, she consulted with her primary again in which she was recommended not to get the 2nd dose of the vaccine and her side effects lean to a more neurologic cause. The doctor mentioned that the vaccine was still too new. These side effects has caused great mental distress, a huge emotional toll, specifically being upset and devastated, lack of sleep, and weight lost due to lost of appetite with 5 pounds being lost within 2 weeks of these side effects. She said that has not been fun. it has been horrible, and she would choose dying over this burning sensation in the mouth. Patient visited physician Office, 3 times and allergist did it virtually. Reportedly, after eating dinner she was eating pineapple from a can. She had the can and tried it. She had not had pineapple in a long time. While sitting in her recliner, she experienced her mouth burning. She added that began about an hour and a half after eating the pineapple and it has lasted for approximately 2 weeks. It was not constant all the time. She did not know at the time if the burning in the mouth was related to the pineapple. Caller added they thought it was the pineapple causing this. Last Sunday, the caller indicated that it was leaving and going away. Caller saw her new primary medical doctor on 09Mar2021. The Nurse Practitioner said it was probably the pineapple, She started her on Benadryl. Manufacturer was unknown to caller. Caller took 2 tablets on 09Mar2021 and stopped taking it on 10Mar2021. She restarted taking the Benadryl on about 14Mar2021. Caller stated she was primarily calling and asking because on Monday, 22Mar2021 she started having burning in her face and had burning in her arm. Caller reported the burning in her arm was not from the vaccine and she thought it was caused by her blood pressure cuff. Caller took her own blood pressure. Burning was better today, she still had burning in her arm. She took Zyrtec as instructed by her physician twice a day. She took a half tablet on 10Mar2021 through 13Mar2021. She was taking half a tablet in the morning and a half tablet at bedtime. Caller added that the Zyrtec made her feel unsteady and it made her sleepy. She did not tolerate it. Dose was 10mg. She has recovered completely from unsteady and being sleepy with Zyrtec. Caller took Tylenol because she was having sinus issues. She did not have the manufacturer, she took it on 12 and 20, two times. Its 325mg, by mouth, the regular strength. Caller saw an allergist on 10Mar2021 who tested her for pineapple allergy. The Allergist called on 15Mar2021 and reported she was not allergic to pineapple. Allergy was also tested for egg white, milk, wheat, corn, peanut, soybean, potato, yeast, and tomato. All resulted as negative. Benadryl: took 2 times in 09Mar2021. Caller restarted Benadryl and took it on 14Mar2021-17Mar2021. These days she only took it in the evening. She took 25 mg at night. Then she took Flonase, twice, on the 17th and 18th. Its over the counter. Lot number: TE8G, caller doesnt have box to provide UPC, stated there was another number of 0140592, expiry Mar2021. Dose was 27.5mcg per spray, spray into each nostril. When providing strength, states writing was so small for her to see. Gets a magnifying glass to confirm strength, states it's with her age. The doctor also suggested for the caller to try Afrin spray on 18Mar2021. Caller started it on 20Mar2021 and used it only once. She didnt like it. Caller said at her age she occasionally breaks out and uses Clindamycin for that. Dermatologist has her using Clindamycin 1 per cent pledgets. Applied twice to face once daily, She stopped 20Mar2021. Given Magic Mouthwash, which was in a pharmacy bottle, she took it once on 18Mar2021, but stopped. It was 5-10ml swish and spit. It made things worse and did not improve it. The doctor forgot to give her a measuring cup, and caller thought she told her a teaspoon. Caller added she tried using a warm cloth on her sinus area and her skin felt like a sunburn. The cloth left a red area around her cheek. Then this Sunday, after using the pledgets, went for a walk, next day noticed her face was really burned, not just face, her neck, arms, but she was not exposed, but had a burning pain, and she still continued to have it. She asked the dermatologist if this could be caused from the Clindamycin. The dermatologist told her no. She took a walk on Saturday and did not know if she was dehydrated. She felt like there were weights on her feet as she walked. It lasted 30 minutes. The burning in mouth started 7 hours after the first dose and it had improved. Therapeutic measures taken in response to the events included Benadryl, Zyrtec, Tylenol, Flonase, Afrin spray, clindamycin, magic mouthwash. Outcome of the events "mouth started to burn/burning in mouth" and "sinus issues" were ongoing-not recovered and for all other events were unknown at the time of report. Information on Lot/Batch number has been requested.

Heart burn complaint later into the night and into the current date/time. My mom has not had heartburn problems in the past.

felt sick/sick as a dog; feeling nauseous; threw up like crazy; funny feeling around her head/Feeling really funny; face usually gets red when her blood pressure is high and it she is not red at this time; vertigo; blood pressure/ up to 210/110 mmHg; not walking well; funny feeling around her head/Feeling really funny; felt chills/Chills; Felt yucky; her balance was not quite right; felt the really funny feeling going up her throat; Her heart rate has been wanting to be a little higher than usual; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 79-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 30Jan2021(at the age of 79-years-old) (Batch/Lot Number: EL1283) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. Family medical history relevant to AE(s) was none and she is getting close to obesity if she keeps eating like this. The patient previously took first dose of bnt162b2 on 11Jan2021, (Lot Number: EK9231, Expiry Date: Unknown, this is not on the CDC vaccine record card) via Injection administered in Arm Left for covid-19 immunisation and experienced Left arm was real sore after first dose injection. The historical vaccine included shingles vaccine. The patient experienced blood pressure/ up to 210/110 mmHg on 20Feb2021 felt chills/chills on 31Jan2021, felt yucky on 31Jan2021, not walking well on 20Feb2021 , felt sick/sick as a dog on 20Feb2021, feeling nauseous on 20Feb2021, threw up like crazy on 20Feb2021, funny feeling around her head/feeling really funny on 20Feb2021, face usually gets red when her blood pressure is high and it she is not red at this time on 20Feb2021, vertigo on 20Feb2021, felt the really funny feeling going up her throat on an unspecified date in 2021, her heart rate has been wanting to be a little higher than usual on an unspecified date in 2021 and her balance was not quite right on an unspecified date in 2021. The patient underwent lab tests and procedures which included blood pressure measurement: 220/110 mmHg (normal value: 120/80) on 20Feb2021, computerised tomogram: doctor mentioned 3 little places on 20Feb2021, electrocardiogram: unknown results on 20Feb2021, heart rate: little higher than usual on an unspecified date in 2021, laboratory test: unknown results on 20Feb2021. Patient received both dose of the Pfizer covid vaccine on 11Jan2021 and 30Jan2021. On the next day after the 2nd dose, she felt chills. On 20Feb2021, she started not walking well, thought she would fall. All of a sudden, she felt sick and threw up like crazy while she was visiting her daughter for the day. The firefighters came to take her blood pressure and it was up to 210/110 mmHg. They advised her to go to the ER. After several hours, she was given blood pressure and nausea pills. They mentioned vertigo. She says it got okay. However, 2 weeks ago, she started to have a funny feeling around her head. Not dizzy but her face usually gets red when her blood pressure high and she was not red at that time. It was again reported that the day after she was administered the second dose of Pfizer-BioNTech COVID-19 Vaccine she had chills and felt yucky that day. She also reported feeling really funny since 20Feb2021. She was asked for further information on events related to Pfizer-BioNTech COVID-19 Vaccine. She was at her daughter and noticed her balance was not quite right. She started feeling really funny so just lay down there for a little bit. When she did get up after about 15 minutes she started feeling nauseous. She got to the bathroom really fast and threw up like crazy. She did not have her blood pressure cuff with her so her daughter called the fire department and took her down there real fast. At the fire station they took her blood pressure which was 210/110 mmHg, so they suggested she head to the emergency room so she did. She was under observation in the emergency room, but not admitted to the hospital. The doctor mentioned vertigo somewhere along the way before she left the emergency room. She just kind of brushed the vertigo off until she was reading about that the Pfizer-BioNTech COVID-19 Vaccine can cause vertigo. She guesses vertigo was what caused these events because she had been sick as a dog. When they got her on the bed and rolled her back she felt like she was going 90 miles per hour and by the time they got her back on the bed she was throwing up again-but this time and the initial onset of throwing up was the only times she threw up. They gave her something after probably 5-6 hours, blood pressure medicine and nausea medicine and she got ok and left there. Her heart rate has been wanting to be a little higher than usual. About 2 weeks ago she was just sitting on the couch and noticed especially when she would turn her head she still feels really funny; not dizzy, dizzy; she was walking ok; but the really funny feeling keeps hitting her continuously. During call when she sat back down she felt the really funny feeling going up her throat. It was just the weirdest thing, she wishes she had a word to really explain what the really funny feeling was but she does not. She has not checked her blood pressure for a while because she has been holding for a while for this department, so her blood pressure could be up a little bit, but she stated event was worse right now than it has been. Regarding testing/investigations while in the emergency room they did a CT head scan, lab tests, and an EKG. CT head scan results, the doctor mentioned 3 little places but when she talked to her doctor he said that was really just nothing to worry about with age; he said they will check it in 6 months and make sure areas are not growing. Caller has no further information to provide regarding lab tests or EKG results, they did not mention anything. Therapeutic measures were taken as a result of blood pressure/ up to 210/110 mmHg and feeling nauseous. The outcome of the events, felt chills/Chills , Felt yucky, her balance was not quite right, felt sick/sick as a dog, threw up like crazy, face usually gets red when her blood pressure is high and it she is not red at this time, felt the really funny feeling going up her throat, Her heart rate has been wanting to be a little higher than usual was reported as unknown, not walking well, feeling nauseous and vertigo was reported as recovering, funny feeling around her head/Feeling really funny and blood pressure/ up to 210/110 mmHg was reported as not resolved. No follow-up attempts are possible. No further information is expected.

Not eating, unable to eat without choking.; Not eating, unable to eat without choking.; Couldn't swallow; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 79-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 01Mar2021 as dose 1, single for COVID-19 immunization.Medical history included gastrointestinal issues and high blood pressure. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it is unknown the patient been tested for COVID-19. 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 was high blood pressure meds, pain meds.On 04Mar2021, the patient was not eating, unable to eat without choking. Couldn't swallow. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. Duration of hospitalization was 30. The patient had not yet recovered from the event.

Chills, fever, dehydration, intense bone pain, intense fatigue diarrhea, nausea, then pneumonia, then pleural effusion, then extreme hypothyroidism, then multiple episodes of elevated pulse/heartbeat. Over a 2 month period.

Mouth around lips and cheek, followed by palette red sores,followed by swollen face,eyes blistering around eyes,burning itchy peeling rash neck,chest,around ears,burning itchy rash fingers to shoulder. On going progressive to present date. Prednisone finally prescribed at Hospital emergency. 40 mg. Per day for 5 days. Dr. is lowering the dosage. The first three weeks are prescribed 40 then 20 on going to 20 and an appointment July 22 to decide on the dosage to continue. I have photos documenting every horrible symptom. I was advised to do that.

she can't lift anything/Patient states she couldn't even roll over in bed, she just laid there like she was dead; muscle and body pain; body pain/ in a lot of pain; shortness of breath; headaches; lightheadedness; weakness; tiredness; chills; joint pain; nausea/Really Bad Nausea; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; weird bumps on her arms that were itchy but now are not; sore throat; she feels like her throat and neck is swelling and tight; weird bumps on her arms that were itchy but now are not/weird bumps on her arm; bone pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0171) via an unspecified route of administration, administered in Arm Left on 09Jun2021 (79-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included ongoing she is disabled and has been disabled for 27 years. Patient states she lost 14 pounds in the last 3-4 weeks, but that was before the shot. The concomitant medications were unspecified. Historical vaccine included flu shot When she gets the flu shot, she can get symptoms for about a week. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. No prior vaccination within 4 weeks. The reporter reported that, she received her first dose of the Pfizer Covid-19 vaccine on 09Jun2021, and then on 10Jun2021 she experienced Muscle and Body Pain, bone pain, sore throat, shortness of breath, headaches, light headedness and dizziness Really Dizzy; didn't know if she was walking forwards or backwards, Weakness; she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it; couldn't hold a pencil, tiredness, chills, joint pain and in a lot of pain, and Really Bad Nausea. The reporter stated that when the patient lays down it feels like her throat and neck are swelling and tight, and she also has weird bumps on her arm, the itching is gone but she can still feel the bumps. she couldn't even roll over in bed, she just laid there like she was dead. The reporter stated the patient is not getting the second dose and not going to the hospital. The reporter asked how long do these symptoms normally last, it's already been two weeks. The reporter asked, "If she can't take the second shot, can the doctor give her a clearance for that, Some places are forcing people to take this." Patient is in the background on speakerphone and states she is not going to the hospital, so forget that. The reporter stated the patient also has weird bumps on her arm, the itching is gone but she can still feel the bumps. The reporter stated that the side effects started on 10Jun2021. Patient states the bone pain lasted a week and a half and then every day something new came, they were kind of sporadic. Patient stated that she has the bumps on her arm, and everything except vomiting, if vomits she is in trouble. Patient states her bones are better some, but the weakness is there, she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it and she still gets dizzy. The reporter stated there are so many different side effects that they are unsure of when each one started and stopped, but most of the side effects are ongoing. Patient stated there is no way anyone will get her to go to the hospital but she just wanted to know how much longer is this going to go on. Patient stated last night she didn't know if she was walking forwards or backwards and she was so weak she couldn't pick up a pencil. Patient stated in the morning she thought she is still alive, she couldn't believe it. Patient stated she will not have the second shot, she cannot. Patient states she can't go through that again, she would rather die. Patient stated she couldn't even roll over in bed, she just laid there like she was dead. Patient states she has had a hard life but never like this. Patient stated she takes a lot of medications but she has been taking them for years and there are no medications or medical conditions that she feels are relevant. No treatment received for events. The outcome of the event muscle and body pain, body pain/ in a lot of pain, weird bumps on her arms that were itchy but now are not, bone pain were resolving and events were not resolved. Information about lot/batch number was provided. Additional information has been requested.

Tiredness; Some achiness; Muscle aches more tenseand uncomfortable; Queasiness; This is a spontaneous report received from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in the left arm on 11Mar2021 at 09:45 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included prediabetes and rheumatoid arthritis. Concomitant medication included omeprazole (MANUFACTURER UNKNOWN) taken for an unknown indication from an unspecified date. The patient previously received penicillin and sulphonamide and experienced an allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 11Mar2021, the patient experienced tiredness, some achiness and muscle aches. On 12Mar2021, the patient reported that the muscle aches were more tense and uncomfortable. On an unspecified date in Mar2021, the patient experienced queasiness. Therapeutic measures included intake of VICKS flu syrup for the adverse events experienced. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events tiredness, aches, muscle aches and queasiness were resolved on 13Mar2021. No follow-up attempts are needed. No further information is expected.

gets hot and then cold and sweating; gets hot and then cold and sweating; gets hot and then cold and sweating; She states the nausea was slight after the first dose but more so after second shot.; headache; not feeling well; no energy; She states after the second shot, her tiredness is worse; She stated after the second shot, her tiredness was worse; Blood pressure high; Fever; Nose bleeds; Severe Chest Pain, fluttering feeling, feels little things; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 13Mar2021 at 10:15 (at the age of 79-year-old) as dose 2, single for COVID-19 immunisation at "PRIVACY" where doctor offices older buildings are. "PRIVACY" now has brand new office, old used for shot and doctors. Medical history included diverticulitis from 2016 and ongoing (she changed her diet. No greasy, no fried, no spicy foods. 2017 attack, 2018 or 2019. Stated that she has felt fine ever since), booster from an unknown date and unknown if ongoing (She stated about 5-6 years ago, she had boosters from childhood shots, every booster. Never had the shingles shot. She stated she has never had a reaction from any of it). Historical vaccine included A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in left arm on 19Feb2021 (at the age of 79-year-old) as dose 1, single for COVID-19 immunisation at "PRIVACY" where her doctor was located, her office was upstairs (the nurses had people spaced downstairs) and experienced a lot of face redness, severe chills, nausea. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that she stated that about a week before the second vaccine she was not sleeping well but she had started to feel better but then she got the second dose and that was a whammy. She stated that when she got the first shot, it kept her awake, like she drank 20 cups of coffee, but after 24 hours, she was just exhausted. She has always been energetic and none of that anymore. She stated after the second shot, her tiredness was worse. She gets exhausted doing nothing. She stated that it was on and off nausea where some mornings felt ok, others she felt nauseated. She does not know if it was the blood pressure pill or not, she was not used to taking any meds. She would probably call the doctor "today" and tell them. She was not used to not feeling well. The patient stated that on 17Mar2021, she got a nosebleed, but she was able to control it and had fever. She called her doctor and told her about the chest pain and nosebleed. She stated the nausea was slight after the first dose but more so after second shot. She was more aware of not wanting to eat and feeling nauseous. She was being cautious because it was so profuse on "Sunday" 21Mar2021 and her blood pressure was so high. "Now", she was on a blood pressure pill and she hopes she does not have another nosebleed. She stated that it was a fluttering feeling, and she can feel little things. It was started testing her blood pressure when it went up on the 17Mar2021. It was 122 and 131. Then on 20Mar2021, it was 174/77 in the "evening" and on 21Mar2021, it really shot up and she went to the hospital and there it was 197/93. She stated that on the 17Mar2021, she was not feeling well and on 18Mar2021, she called her doctor and they told her to stay hydrated and take her blood pressure. She stated then on 21Mar2021, it got really bad. She stated with the medication since the 21Mar2021 "Sunday". On 22Mar2021, it was 156/91 and 128. It was 107/64 "yesterday" and "now" 117/75. She stated that it seems to be back down where it usually has been, more towards lower rather than the higher reading. She has never experienced high blood pressure. She stated that the ER (emergency room) doctor said her problem was high blood pressure and you have had for years but she states she has not. She stated in 2016, she went to the hospital for a diverticulitis attack and then it went back low again at doctor office. In 2017, she went to the ER (emergency room) with diverticulitis. She stated the ER (emergency room) doctor was looking at the blood pressures from times when she was in the ER (emergency room) in 2016, 2017, and 2018 or 2019. She stated that after the ER (emergency room), she always maintained her blood pressure, but he put her on a blood pressure pill, but she was questioning it because she has always maintained low BP. She has never had high blood pressure in her life, it always runs low. On 21Mar2021, emergency room doctor said her blood work for her age looks very good and she really was very healthy. She was thinking, then why was she there. Stated her blood work looked very good and she looked very healthy. The patient was received the treatment in ER (emergency room), Amlodipine, talked to nurse yesterday afternoon and she asked how she was feeling, not like feeling bad, no energy. They gave it to her IV (intravenous) to bring her blood pressure down on "Sunday" (21Mar2021). " Physician office: Followed Up with Phone Calls, 06Apr2021 she has a follow-up appointment ". The patient underwent lab tests and procedures which included blood pressure: 174/77 (unknown units) on 20Mar2021, 197/93 (unknown units) on 21Mar2021, 156/91 (unknown units) on 22Mar2021, 107/64 (unknown units) on 23Mar2021, 117/75 (unknown units) on 24Mar2021. The outcome of fever was resolved on 17Mar2021, nose bleeds was resolved on 21Mar2021; Severe Chest Pain, fluttering feeling, feels little things, Blood pressure high, her tiredness worse, Nausea aggravated was not resolved; gets hot and then cold and sweating, headache, not feeling well, no energy, was unknown No follow-up attempts are possible. No further information is expected.

Severe headache; Muscle aches; Feeling of unwell; Fatigue; Chills; Hot flashes; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 79-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the arm left on 12Mar2021 at 10:00 (at the age of 79-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic fatigue and grave's disease. The patient had unspecified allergy to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 10:15, the patient experienced severe headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea. It was reported that, the headache was absolutely severe to the point that it was hard to keep eyes open and see. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea. The clinical outcome of events severe headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea were resolved on an unknown date in Mar2021 (lasted 3 and half days). No follow-up attempts are possible; information about lot/batch number cannot be obtained.

constant diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9810) via an unspecified route of administration in the left arm on 19Feb2021 at 17:30 (at the age of 79-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on an unspecified date ; as a single dose for COVID-19 immunisation. Medical history included arthritis, two hip replacement, two knee replacement, shots in hands and feet every three months and low kidney function. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Feb2021 at 11:00 the patient experienced constant diarrhea. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of diarrhea and included treatment with unspecified antibiotic prescribed by the doctor. The clinical outcome of the event constant diarrhea was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

freezing with chills, and turned up the heat.; node on my arm; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; freezing with chills; freezing with chills; Nausea; slight headache; This is a spontaneous report from a contactable consumer(Patient). A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:30 (at the age of 79 years) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration, administered on 01Mar2021 as single for COVID-19 immunisation. Patient states she had the second shot yesterday and adds she didn't have any side effects from the first one. After the second one, by 20: 00PM she had nausea for about an hours and a slight headache that went away by the time she went to bed. Then early the next morning she was freezing with chills, and turned up the heat. Adds she didn't have all that with the first one. Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it. She is asking is all this a normal side effect. Mentions she took her temperature and she doesn't have a fever. Patient Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 01Mar2021 in the afternoon in the left arm and the second dose on 29Mar2021 at 12: 30PM in the left arm. Patient further stated that "I got a node on my arm and it has fluid in it and I didn't have that before, so I'm concerned about it." The outcome of the events Nausea, slight headache was recovered on 29Mar2021 while the freezing with chills was recovered on 30Mar2021. While the outcome of the rest of the events were unknown. No follow-up attempts are needed. No further information is expected.

she started to get very sick, which continued to worsen until nowwhen she feels like she is improving; had stomach and abdominal pains; had stomach and abdominal pains/stomach is still very sensitive; loose stool; she was very tired; Pain or little discomfort in the arm she received the injection; Pain or little discomfort in the arm she received the injection; This is a spontaneous report from a contactable consumer (Patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, EH9896), via an unspecified route of administration to very top of right arm on 22Dec2020 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included glaucoma she had drops to take for, mostly she just has problem with her joints and her back with her age. She did not have any diseases or anything; she was not diabetic, nothing like that. There were no concomitant medications. She was administered her first dose of COVID-19 Vaccine on 22Dec2020. She reported that the pain or little discomfort she had in the arm she received the injection in disappeared by 25Dec2020. But on 24Dec2020 she started to get very sick, which continued to worsen until now when she felt like she was improving. She did not know if these events could have something to do with the COVID-19 Vaccine. Pain or little discomfort in the arm she received the injection: Right arm. Everyone warned her that the site would hurt, so she was really glad when it totally went away on 25Dec2020 and thought that it was over; any issues from the injection. Very sick: this event started to get bad on 24Dec2020, she was very tired and not very hungry, she had stomach and abdominal pains and loose stool; 25Dec2020 those symptoms were worse. It was Christmas so she cooked and thought at first maybe she got carried away baking pies; because that evening she started to have pain and did not each much. 26Dec2020 it was worse; she said she was going to work on 27Dec2020; it was terrible because she was stuck for 12 hours trying to work while very sick. She called off of work 28Dec2020 and 29Dec2020. Since then she has stayed home and still has pain but she took her ranitidine delayed release 100mg twice daily as needed for stomach pain as given to her by her doctor, and is now down to just once daily. She did not know what she would have done without the ranitidine. She did not have any more abdominal pain, but her stomach was still very sensitive. She was tired but thought she was going to be ok. She was scared to get the second scheduled dose of COVID-19 Vaccine because she thought the side effects will be more severe with the booster shot. She just needed to rest and stay home which she has been doing. She has not had any fever. She has not notified her family doctor of these events. There was nothing she did on Christmas that she could think of other than she drank a glass of champagne because she did not know her stomach was going to be so bad. The outcome of the events Pain or little discomfort in the arm she received the injection was recovered on 25Dec2020, the outcome of event sickness was recovering, the outcome of the event Abdominal pain was recovered on an unknown date in Dec2020, the outcome of event stomach pain was not recovered, the outcome of the other events was unknown.

Patient c/o severe nausea. RN offered pt a seat near the bathroom. Pt sat down and waited until nausea decreased. RN gave pt a bottle of water and she drank about 60ml. After about 10 minutes, pt stated she was still nauseous but felt slightly better. RN ensured pt that she could stay as long as she needed to and until her symptoms subsided. Pt and family member agreed that they were comfortable enough to head home. RN instructed pt to notify healthcare worker of her episode of nausea before she received the second dose of the covid-19 vaccine.

On Saturday, 1/16/2021, Patient went to the grocery store. Upon her return, she indicated she was experiencing N/V and some throat swelling. Patient subsequently collapsed and expired before she could be brought to an emergency room. During investigation by Coroners Office, it has been reported that Patient may have gotten some takeout food while she was out. Labs are pending and the Coroners investigation is ongoing. Spouse believes that her death was caused by the vaccine.

Abdominal Pain similar to a diverticulosis attack except on the lower right quadrant. After discussion and physical exam (no other tests) with Doctor, we decided to treat with an antibiotic (AMOX_CLAV 875-125 MG Tablet) and see if I got better. One day later, pain has subsided.

waves of heat in hands, arms, chest up into head . 3x per day. feel tired and naesous afterwards. still happening after one week

High fever 101.7 for two days. Extreme shakes all night on the25th. Advil taken every four hours. Stomach cramps and loose bowels the next day.

I had terrible bloating and gas January 22, all day diarrhea January 25 and gas all this week which is only helped by heating pad on stomach and when ready to exit standing to release gas from bowels, plus have had to take the simethicone 6 to 7 times per day.

Almost uncontrollable shaking, 2.3 degree increase in temperature, really bad diarrhea . Symptoms lasted around 12 hours, temperature came down in a day and I took Tylenol

Dull Headache coming and going. Nausea starting on Sunday, January 31, continuing on Monday, February 1. Pain in lower abdomen.

day after injection i had slight head ache on Friday night i was shaking uncontrollably and then Saturday i got nausea.

I began with mild arm ache 24 hours after vaccination, 72 hours later the site became swollen, red and itchy. Overall I feel fatigued and lost my appetite. In addition when I had CoVID in September I experienced difficulty falling or staying asleep. I experienced that last night again. I am very tired but unable to fall asleep.

Patient came back from cardiology appointment (at 2pm) unresponsive. It was reported that she had vomited while at the appointment. She was confused when she could be aroused, stating that she does not have a name.

Started not feeling right- her stomach was bothering her; diarrhea; Her face turned red; Face and chest felt like they were on fire; Freezing and could not warm up; She was very crampy; nauseous; Left arm soreness; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL3247) solution for injection intramuscular in the left arm on 19Jan2021 (at the age of 80-years-old) as a single dose for COVID-19 vaccination. There was no medical history. There were no concomitant medications. On 19Jan2021, the patient started not feeling right- her stomach was bothering her, diarrhea, her face turned red, face and chest felt like they were on fire then freezing and could not warm up, she was very crampy, nauseous and left arm soreness. The outcome of the events stomach discomfort, diarrhea, feeling hot, feeling cold, very crampy and nauseous was recovered on 19Jan2021. The outcome of the event face turned red was unknown. The outcome of the event left arm soreness was not recovered.

EMT and PHN responded to Pt hunched over, C/o sudden onset of abdominal cramping and pain, 7/10, and throbbing HA 7/10 pain. Denies dizziness, nausea, itchiness, swelling. Vitals taken at 1:53 pm: BP 510/88, HR 60. Pt request to go to bathroom, ambulated self with steady gait to restroom. Pt assisted by son, in bathroom. NO BM, reports pain comes and goes from 7/10 to 3/10.. Pt walked back to reclining chair in vaccination observation area. Vitals recheck at 2:13: BP 156/90, HR 52, 28 respirations., reports no change in pain or HA. Pt wincing and bending over, 9-1-1 activated, EMS on scene at 2:20 pm. Pt refused ED transport/and care, Pt walked off site with son, states will go to clinic ASAP.

Within 15-minutes of vaccination, the patient reported dizziness and a heartburn sensation in her chest. EMS noted orthostatic hypotension in the field, systolic was in the 130s when sitting with a rapid drop to the 70s upon standing. Patient was transported to emergency department. In the ED, the patient reported having a dry mouth and having not eaten breakfast. Patient was administered IV fluids and noted improvement. Labs were unremarkable. Diagnosed with orthostatic hypotension secondary to dehydration, vasovagal episode, and GERD.

2 hours after shot felt nauseous. 6 hours after shot had vomiting and diarrhea. Repetitive vomiting 14 hours and diarrhea and malaise for 36 hours.

Day after receiving the vaccine, the patient complained of abdominal pain which worsened over the day. She went to the ED and was hospitalized. Abdominal pain complaints increased and continued, she decompensated rapidly, was intubated and subsequently died 3 days later. Imaging results showed, progressive ovarian cancer in the bowels. Blood culture revealed that she had E.Coli in her blood. It is thought that this is NOT related to the vaccine.

The night after receiving dose 1 of the vaccine, she didn't want to eat dinner, was starting to spit up saliva, and noted a new headache, and asked her daughter to sleep with her that night considering she was feeling poorly. She was restless all night, and then at ~5am her L arm began to twitch; she was still alert at this time but didn't realize her arm was moving. Shortly after this she lost consciousness, her eyes rolled back in her head, and she developed a frank GTC seizure. Her daughter called an ambulance, and by the time she was on the way to the hospital, she was awake and alert again. At the hospital, she was initially talking and able to answer most questions appropriately. She was noted to be afebrile, hemodynamically stable, without an O2 requirement, though with tachycardia to the 110s. She was found to have a leukocytosis to ~16, thrombocytosis to ~550, and LDH elevated in the 600s. Over the following day, her mental status declined and she became agitated and disoriented to place/time. CT chest revealed b/l multifocal pneumonia, for which she was started on pip-tazo. She underwent MRI brain (DWI sequence only) which did not reveal any obvious CVA. LP was performed on 1/29 at ~10PM; as far as we can tell, she had only received pip-tazo for antibiotics at this point. CSF studies revealed 220 WBCs (14% PMNs, 76% lymphs, 10% monos), 14 RBCs, Glu 59, Prot 145; GS 2+ WBCs, no orgs; india ink stain negative; Cx pending at time of transfer. Given concern for bacterial or viral meningoencephalitis she was transitioned to vancomycin/ceftriaxone/acyclovir. Patient was then transferred to another Hospital for further management. Micro was all negative or pending at the time of transfer. Shortly after admission to hospital she was intubated. Spine MRI was notable for longitudinally extensive transverse myelitis. All infectious workup has been negative with just two more pending studies for tuberculosis; autoantibody panel pending. She is now able to follow commands with eyes and mouth, but has not been able to move her arms or legs. We do not have high suspicion that this syndrome is related to the vaccine, given that progressive neurological symptoms started the week before vaccine, but thought it prudent to report given the time course.

Became dizzy when she bent over to tie her shoe. Came to lie down for dizziness to pass. Reported a headache and being hungry. Juice and trail mix given. Later went to the restroom and vomited a small amount per client. Rested further, reported her headache improved and wanted to go home. Was informed we would like for her to get a ride home. She did not want to and declined to stay for further observation. b/p 138/76 pulse 72. Informed to seek medical help for further problems.

I am a well 80 year old woman. I have no preexisting medical conditions. I take no prescribed drugs or over the counter medications. I had no side effects for shot one. The second day after shot two I had a very very severe headaches for 22 hours. When I tried to drink water , it came right back up. I could not keep anything down for the same 22 hours. I am now fine.

chest pain, diaphoresis, incontinence, N/V, dizziness; symptoms are no longer occuring after be treated and released from hospital 2/3/21

Pt rec'd vaccine two days ago and was sick a day later, light fever, chills, joints hurt, headache, having a hard time raising the arm, it's very sore, nauseated, lasted 1 day.

First shot no problems. Second day after second shot, fatigue, could not get warm, redness and heat at the injection site. Diminished appetite. Body aches. Third and fourth day after shot redness and itching at injection site

Extreme stomach distress: Nausea, diarrhea, stomach unsettled/growling, afraid to eat. Gradually better by 02/21/2021 (light eating all day) and feeling pretty well today (02/22/2021)

0920, reporteed thickness in back of tonge,c/o trouble swollowing, able to drink water, 126/72, hr83, 02 sat 96% RA, rr 16 Called rapid response, NP assessed and rec ER, pt refused. 0940 Benedry 50 mg po given. Refused ER again, Agrreded to monitor until 11am Checked out At 11:10. Denied other symptoms.

pt states that she had a left arm and mild body aches for a couple of days after getting the covid vax. Three or four days later she started getting dizzy and nauseated. She says she feels hungry even after she eats. Pt states the dizziness comes and goes and is normally in the morning. She doesn't feel right and feels unsafe when she walks like she may fall. Pt contacted her PCP on 2/23/2021 and they just told her to see if the symptoms went away and the FU if they did not.

On 2/2 received 1 st dose of vaccine. On 2/14 developed nausea, vomiting and diarrhea. Admitted to hospital and found to have a troponin of 72 and coronary angiogram done. Endomyocardial biopsy revealed myocyte damage and mixed inflammatory infiltrate concerning for myocarditis. Patient ultimately has started to recover with treatment of methylpred 1 gram x 3 days.

Lightheaded; Weakness; Nauseated; Vomiting; did not have an appetite; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. Medical history included stroke 14 years ago. Concomitant medication included warfarin. The patient was lightheaded, did not have an appetite and experienced weakness on Jan2021. She was even nauseated and threw up earlier on Jan2021. She wanted to know what can she do. She had nauseousness and vomiting. She vomited one time but she was not currently vomiting and just took some Ginger ale to settle her stomach. Patient was asking what to drink or does she take any Tylenol or let it. Outcome of the events was unknown. The date of second dose was 16Feb2021 Information about batch/lot number has been requested.

Chills, vomiting, worsening confusion. Patient had vomiting that began about 48 hours after vaccine dose. Had subsequent chills. No fever. Evaluated by her primary care provider on 2/26 AM and the ER at Hospital on 2/26 PM. Noted to have chills, nausea and vomiting in the ER. Also noted to have tachycardia, likely related to her atrial fibrillation. She had been unable to take her home medications due to vomiting and had missed her rate controlling medications. She was given IV Zofran and Tylenol with good control of her chills and vomiting.

No adverse events following the first dose on 02.05.2021 The second dose on 02.26.2021 : fever - highest 101.2 degrees; slight headache; nausea; deltoid pain; anorexia; loose stools; fatigue I was pleased to have a reaction suggesting to me that some immune response was being generated.

Patient had her second COVID vaccine on 2/20/21. The next day she developed diffuse body aches. She went on to develop worsening dyspnea and fever to 103°F on February 23. She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed. She therefore presented to the ER on 2/25/21. See full history below from infectious disease note on 3/1/21: Patient is an 80 year old female who has a past medical history notable for hypertension, dyslipidemia, and hypothyroidism. The patient was diagnosed with a high-grade lymphoma of the retroperitoneum in 2004 and completed 4 cycles of multi-chemotherapy (Cytoxan, Adriamycin, vincristine, methotrexate, and IT chemotherapy (Magrath-like regimen)). She completed 4 cycles with complete remission on PET scan. The biopsy of a left cervical lymph node in 2007 revealed follicular lymphoma and she completed radiation therapy to the neck with complete remission. A left axillary lymph node biopsy in 2016 revealed grade-3 follicular lymphoma with mixed follicular and diffuse histology. Chemotherapy was pursued. The biopsy of a pelvic lymph node in 2019 was consistent with G1-2 follicular lymphoma.  She completed radiation to the pelvis in May of 2019.  She developed progressive pelvic adenopathy in April of 2020 and received 5 cycles of chemotherapy. Subsequent CT showed improvement in the adenopathy.  Her course was complicated by pulmonary emboli (September 2020).  In November of 2020 she was started on maintenance Rituxan every 2 months.  She received the 2-dose Pfizer COVID vaccine series on 1/29/21 and 2/20/21. With the above background, the patient presented to the emergency room on February 25, 2021 with complaints of diffuse body aches, which had developed that day after receiving her second dose of COVID-19 (SARS-CoV-2) vaccine.  She went on to develop worsening dyspnea and fever to 103°F on February 23.  She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed.  She called Oncology on February 20 and it was recommended that she go to the emergency room for evaluation.   She was afebrile on presentation to the emergency room.  She was tachycardic, however, with a pulse rate of 117 bpm.  She was breathing at 48 breaths per minute.  Blood pressure was 105/80 mmHg.  Oxygen saturation by pulse oximetry was 96%. Examination was notable for paraspinous muscle tenderness, tachypnea, mild respiratory distress, and a mildly distended abdomen.  Mild erythematous patches of the feet and forearm were noted, as well as evidence of edema of the right leg from the knee to the lower leg. The peripheral blood leukocyte count measured 0.8x10e3/µL.  ANC was 0.48x10e3/µL.  Platelets measured 96x10e3/µL.  Creatinine was 0.97 mg/dL.  AST was 86 and ALT 20 U/L. The lactic acid level of the venous blood was 3.6 mmol/L. The procalcitonin level of the blood measured 28.37 ng/mL. The C-reactive protein level was 313.7 mg/deciliter. The creatine kinase (CK) level was 4023 U/L.  LDH measured 314 U/L. Troponin was 3.22 ng/mL.  Urinalysis showed 6-10 wbc?s, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, hyaline and granular casts as well as amorphus crystals. A chest radiograph showed possible, but not definite, mild atelectasis or infiltrate at the left lung base.  A radiograph of the right tibia/fibula showed circumferential soft tissue edema seen within the knee and upper to mid aspect of the lower leg.  EKG showed sinus tachycardia but no evidence of arrhythmia or ischemia. Cultures of specimens of the blood were obtained.  The patient was started empirically on vancomycin and cefepime and was admitted.   Faint erythema and ecchymosis of the right leg extending to the dorsal right foot and right wrist erythema were noted following the patient?s admission.  Her condition subsequently destabilized with increased respiratory rate, worsening pain, and hypotension, so she was transferred to the ICU. An abdominopelvic CT on February 25 revealed a small amount of free fluid in the abdomen around the liver, cholelithiasis with no evidence of acute cholecystitis or biliary dilatation, a nonobstructing 5-mm stone of the mid pole of the left kidney, coronary artery calcifications, mild infiltration of the fat in the inferior retroperitoneum and along the right common iliac region with small nodes in this region, similar compared with September 24, 2020, but improved compared with April 30, 2020, and consistent with response of lymphoma to chemotherapy; a myomatous uterus. A CT scan of the right lower extremity showed extensive edema about the subcutaneous tissues of the right lower leg and infiltration of the fat about the muscles of the right lower leg, likely representing cellulitis and fasciitis, and possible myositis. However, there was no air within the subcutaneous tissues or muscles to suggest necrotizing fasciitis and no evidence of abscess.     The patient?s antibiotic treatment was later changed to vancomycin, piperacillin-tazobactam and clindamycin. Cultures of specimens of the blood were later reported as being positive for methicillin-susceptible Staphylococcus aureus on 2/2 sets. Repeat blood cultures (February 26) were positive as well. Her antibiotics were modified to cefazolin monotherapy. Repeat blood cultures on Feb 27 and 28 were negative.   TTE completed 2/27/21 without obvious vegetation.   TODAY (3/1/21): Cultures negative 2/27 and 2/28. Remains on IVIG. Afebrile. She complaints of continued pain in the Right leg and swelling at that left arm. Exam GENERAL: NAD EYES: Sclera and conjunctiva clear NECK: no adenopathy LUNGS: Breath sounds normal and symmetric. No rales or wheezes. HEART: regular rhythm, no murmur appreciated ABDOMEN: Soft without mass, tenderness, organomegaly or hernia. EXTREMITIES: RLE with ecchymosis, slight overlying erythema and anterior blister: blistering more pronounced today. left foot with plantar erythema, some tenderness today. LUE fullness with some heat/tenderness SKIN: No other rashes or other abnormalities are noted. NEUROLOGICAL: alert, appropriate Assessment 1. MSSA septicemia with shock. Positive blood cultures 2/25 and 2/26 thus far. Negative since 2/27. 2. Multifocal cellulitis and interstitial infective myositis of LE- suspect related to above. CT scan was negative for apparent necrotizing infection. 3. Elevated CK due to above- improving 4. Recurrent lymphoma- has been on maintenance rituximab (11/2020). Immunocompromised state. 5. Low immunoglobulins- remains on IVIG 6. Positive urine cultures with Staph aureus- this is typically secondary seeding from bacteremia rather than primary staph uti. CT abd/pelvis negative for nidus of infection along GU track (no renal abscess for example) 7. LUE swelling/tenderness.   Plan 1. Cont Cefazolin without change: goal dosing 8gm/24hr 2. Following repeat blood cultures, negative thus far (tentative D0= 2/27/21) 3. Pending course, anticipate likely TEE--- > presently precluded due to thrombocytopenia 4. Will obtained LUE doppler for completeness given pain/swelling here. Down the line, may need to consider additional imaging (CT?) if concern for abscess, etc). 5. ID will follow along with you. Please call if any questions/concerns. Patient is still admitted, and is in the ICU.

first vaccine 2/4/21 el9265 first vaccine , second was 2/25/21 en6200 - second vaccine headache, vomited ice to headache and arm, food and fluids very difficult to understand caller , shaky voice ( dystonia)

Had shallow breathing; Very weak; Could not walk; Disoriented; Wanted to sleep; Incoherent; couldn't/wouldn't eat; Dehydrated; This is a spontaneous report from two contactable consumers (primary reporter was patient's husband). An 80-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included ended up in the hospital for 2 weeks with pneumonia and COVID-19 at the end of last Summer. The patient's concomitant medications were not reported. The patient's husband reported that the patient received the first Covid shot about a week to two weeks ago. She went to the facility and got the shot and was fine afterwards until she came home. Later that afternoon, she started showing symptoms of problems, was weak and couldn't walk, disoriented, wanted to sleep, was incoherent, couldn't/wouldn't eat, was very, very much having trouble, shallow breathing. He tried to stay right her and eventually it got to be scary for him with her shallow breathing. He ended up calling an ambulance and she went to the hospital. They gave her tests and was there until about 4 or 5 in the morning before she started showing signs. She was dehydrated was a part of it. The tests were showing the symptoms were improving and she was beginning to come out of it fortunately with doctor's care because he didn't know what to do. He had been going through materials and she is coming up on another shot next Monday and does not want her to go through that if it can be helped. She was coming up for the second shot. Saw something on the tv that rattled him to his bones. It had been found that people who had Covid virus previously and then got the shot may not need a second shot. He is trying to flush that out to whether or not that is something or not that she should be considering. They have the card to go back to the same place for the second shot and they are trying to figure if they need to set up an appointment now. Hoping that this was the worse of it and it is hard for them to call back and his physician is not an expert on this and he got Pfizer's office contact number and decided to call. Outcome of the events was recovering. Information on the batch/ lot number has been requested.

Chills; Fever; aches and pains; no appetite; felt weak as a kitten; injection site got swollen; having pain where the injection occurred; she had felt like she was at death's door; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose on BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN6200) solution for injection, via an unspecified route of administration in right arm on 15Feb2021 at a single dose for Covid-19 immunization. Medical history included allergies, hip surgery, and foot surgery three times. Concomitant medications included unspecified medications. Patient reported she has been so sick. She got the shot on Monday 15Feb2021, and that same day she got so sick, it was horrible. Patient had chills, fever, aches and pains, and if someone named it, it was there. She stated that before Monday she was 183 pounds, didn't know if it has changed as she has not been on a scale, but she was sure it has because hasn't eaten since Monday, as she has had no appetite. Her appointment was at 07:45, and she went right when she got up, so she did not really have anything to eat on Monday. Patient stated that on Tuesday, she did not eat anything until the evening when she had one piece of pizza. Today, patient has only had a yogurt. Today was the first time she has gotten out of bed and even felt like getting dressed and putting her contacts in, since Monday. The last few days, patient stated that after getting up and going to the bathroom she would walk downstairs and felt weak as a kitten (15Jan2021). Patient stated that she was at least 80% better, because she had felt like she was at death's door (Feb2021), and she was not a wimp, it was just horrible. Patient mentioned that she was on a lot of medicine, probably 10, but this was the first time she was receiving this vaccine. She stated that she was still having pain where the injection occurred (Feb2021), like when her shirt touches it, she can tell it was there. But patient stated that she had the nicest nurse and the injection itself did not hurt, it was just later, and the injection site got swollen (Feb2021). Outcome of the event she had felt like she was at death's door, chills, fever, aches and pains, felt weak as a kitten was recovering; no appetite was not recovered; while the other events was unknown. No follow-up activities are needed. No further information is expected.

Had shot on Thursday 2/25/21. Friday didn't feel well-laid around all day. Saturday was so dizzy I had to hold on to walls and furniture to walk around house. Sunday was still dizzy and nauseous so I ate a sandwich and 3 or 4 tums. All came up and I continued to vomit throughout the day. Could not even keep water down. Monday I had someone bring Ginger Ale. Nausea gone, but still very dizzy. Never had a temperature but continue to be dizzy. I am a very active 80. Clean my own house and Mow my yard. I play bridge 2 or 3 times a week and walk my 2 Yorkie Dogs several times a week and never have been dizzy before.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department with increasing shortness of breath, fever, and cough one day after receiving second vaccine dose. Patient has been experiencing these symptoms for a month prior to arriving at the emrgency department but worsened just prior to arrival. Vital signs: blood pressure 136/75 mmHg, pulse: 96 beats per minute, temperature 36.5 degrees Celsius, respiratory rate 26 breaths per minute, and oxygen saturation 84% on room air (97% on three liters of oxygen via nasal cannula). Physical exam notable for chills, fatigue, fever, cough, dyspnea, nausea, urinary frequency and urgency, headaches, rales, and an irregularly irregular heart rhythm. Patient diagnosed with pneumonia, anemia, gastrointestinal bleeding, and urinary tract infection, administered intravenous fluids and antibiotics, and admitted to another hospital for further care.

On 2/17/2021 (2nd dose)about 4 p.m. started feeling nauseous and dizzy-injection arm became very sore. The next 2 days t he same as late afternoon on the day of injection. 2/20/2021 woke up feeling fine. 2/21, 2/22 back to feeling nauseous and dizzy with the injection arm hurting a lot. 2/22, 2,24, 2/25 were fairly good days. But 2/26 woke up at 3:30 a.m. feeling very, very nauseous and then vomiting violently and again at 6:30a.m. and 8:30a.m. (along with a bad case of diarrhea. Was nauseous for the next 3 days and could not move my left arm above my elbow.

On 3/6/21 - One hour after the shot, left facility and drove home -- my nose became quite stuffy -- muscus membrane swelling mainly -- not much phlegm to be cleared out - settled down about an hour later without taking any medications. Starting on 3/7/21 - Sore & stiff muscles in both arms - aching joints and muscles in legs also, stiff neck and waves of nausea that come and go. - also very groggy & fatigued On 3/8/21 - Woke up more aching, swollen glands under left arm and headache starting - took only Tylenol for the headache . Rest of symptoms still in effect. Stayed home from work to take it easy. Hoping things will pass by tomorrow or Wednesday

symptoms, Shortness of air, sat 93% room air, cough, headache, diarrhea. exposure to positive family member approx. two weeks prior to office visit on 03/01/2021, was scheduled for Monoclonal antibody treatment.

On the 5th day after receiving the vaccine I became dizzy. The next morning I became very dizzy and went to the hospital. They admitted me to Emergency because my blood pressure was extremely high-they said later it was about 187/ ?. While I was there the blood pressure went up over 200 to 214/81. I was dizzy and nausious and shaking because I became very cold even though the nurse covered me with 3 blankets. After I left the hospital it took until after I got a prescription for meclizine filled and took one at 7PM before I was able to get the blood pressure down to a normal range - 130/64. Today I am still taking meclizine as prescribed and am still slightly dizzy. I do not know if this was related to the vaccine or not.

Received vaccine on 2/17 at local health department clinic and presented to the reporting person's facility ED on 2/24/21 with a 4 day h/o N/V and headache. patient was provided symptomatic treatment and discharged to home.

Very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days; Diarrhea; Vomiting day 4 to day 6; Continuing nausea; Continuing nausea with loss of 5 lbs; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810), via an unspecified route of administration, right arm on 14Feb2021 12:15 PM at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient wasn't pregnant at the time of vaccination. The patient's medical history included Allergies to medications, food, or other products included Sulfa, gluten and cortisone meds, diabetes since age 5 and heart failure. List of any other medications the patient received within 2 weeks of vaccination included Thyroid, metoprolol succinate (TOPROL XL), KCL, furosemide (LASIX [FUROSEMIDE]) (reported as Lasux), spironolactone. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days on 17Feb2021 12:00 PM, diarrhea and vomiting day 4 to day 6 and now continuing nausea with loss of 5 lbs because of nausea at day 11 on Feb2021. The patient received additional insulin as a treatment and call to cardiac physician. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the event Blood glucose increased, Diarrhea, Vomiting, Weight loss was recovering and outcome of event Nausea was not recovered. Information regarding lot/batch number has been requested.

Nausea, severe headache, pain in left leg, mouth has copper taste, cramping on the third day after vaccine. Never reached out for treatment.

bleeding from ileostomy; abdominal pain; This is a spontaneous report from a non-contactable pharmacist. An 80-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), intramuscular on 28Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Iodine, Levaquin and Morphine and experienced allergies. It was unknown if the patient received other vaccines in four weeks. The patient experienced abdominal pain and bleeding from ileostomy on 01Mar2021 at 11:00PM. The events resulted in emergency room/department or urgent care and hospitalization. The patient had no COVID prior vaccination and had not tested post vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Based on the information available the events abdominal pain and bleeding from ileostomy are attributed to intercurrent medical conditions that were not related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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.

Patient reported swelling on back of the neck about 5 minutes after receiving vaccine, was given Benadryl 25mg. Several minutes later reported difficulty swallowing and was administered 0.3mg of epinephrine. Daughter called 911, patient reported feeling better after emergency response arrival.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Medium, Systemic: Shakiness-Medium, Additional Details: Patient reported allergy to flu vaccine, asked for reaction and she did not report anaphylactic symptoms. Patient told that we will watch over her after receiving the vaccine. About 5 minutes later, swelling on back of the neck reported and gave Benadryl 25mg. Later reported difficulty swallowing and administered 1 dose of 0.3mg epinephrine. Daughter called 911, after arrival patient reported feeling better but still taken to ER. Daughter said she felt better at ER.

The following reaction signs/symptoms were observed: abdominal pain, nausea and other dizziness with vomiting Emergency response notified: EMS (911) EpiPen administered by RN as per standing order?: No Required VAERS reporting completed?: No Report given to EMS (911) EMT evaluated her Found her to be stable enough to wait at parking lot until symptoms resolved. She stayed in lot with daughter on phone until 115 when she reports her symptoms resolved and was able to drive home RN took vitals

she experienced Diarrhea; she had muscle weakness in both legs and back; legs felt weak; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 05Feb2021 13:40 (Batch/Lot Number: EM9810) as single dose for covid-19 immunisation. Medical history included Diabetes from Mar1964, she does some exercise after the shower for the hip surgery done prior to the vaccine. Concomitant medication included insulin lispro (HUMALOG) uses with a pump taken for diabetes mellitus. Caller stated she received her first dose of the Pfizer covid vaccine on Friday, and yesterday morning 09Feb2021 she experienced Diarrhea and then later on she had muscle weakness in both legs and back. She does some exercise after the shower for the hip surgery done prior to the vaccine and uses a cane to walk. She said she is a little better today and wanted to know if that was due to the vaccine. Outcome of the event she had muscle weakness in both legs and back was unknown. Outcome of the other events was recovered on 10Feb2021.

reported Blood Pressure jumping/blood pressure shot up; nausea; headache; icky feeling; patient experienced light headedness, dizzy and icky feeling; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 80-years-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6204, Expiry date: Unknown) via an unspecified route of administration in left arm on 10Mar2021 13:30 as single dose for covid-19 immunisation. Medical history included hypertension, caller says she has had hypertension prior to getting vaccine. The patient previously took first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6201, Expiry date: Unknown) via an unspecified route of administration in right arm on 17Feb2021 as single dose for covid-19 immunisation. There was no family history relevant to adverse events. There were no concomitant medications. Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 13Mar2021, patient experienced light headedness, dizzy and icky feeling, on 15Mar2021, experienced blood pressure jumping/blood pressure shot up and on an unspecified date patient experienced nausea and headache. Caller says she has had hypertension prior to getting vaccine. Caller got her 2nd dose, "last Wednesday on 10Mar2021". Caller says she had no issues until Saturday/Sunday. Caller experienced: nausea, light headedness, icky feeling, headache. Caller says she has never had a "continuous headache before". Caller had a pre-existing appointment with doctor that Monday after. During appointment, caller had systolic blood pressure reading of 205. Caller says the doctor "gave me a little orangeish coloured pill, she was monitored after that in office." Caller says she was told to go to emergency room from doctor office. Caller had EKG and blood work done at emergency room and sent home to continue to monitor blood pressure and follow up with her doctor. Caller is asking, "has anyone else reported Blood Pressure jumping". Caller also says, "I know people have headache and nausea, how long does that usual last" Caller asking how long her headache might last. Dizzy/Lightheaded/Icky feeling: She said that she still has a kind of a funny headache. She said that she is never really sick and can't even remember having a cold. Caller said that her blood pressure is currently in the 140's and 150's systolic. She said that it has been high for a number of years, but it has never been as high as 205 that she can recall. Caller said that her blood pressure dropped while she was at the hospital and she was discharged from the emergency room. The caller was not admitted to the hospital. Caller does not remember the diastolic number from her blood pressure. The patient underwent lab tests and procedures on 13Mar2021, which included blood pressure measurement: systolic was 205. The outcome of the events light headedness, dizzy, icky feeling and blood pressure jumping/blood pressure shot up were recovering and nausea, headache were unknown.

Off balance; Slight nausea; Slight headache; Not feeling well; This is as spontaneous report received from a contactable consumer (patient herself) of 80-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/Expiration date: Not reported) via unspecified route of administration on 12Feb2021 at 09:15 AM as a single dose for COVID-19 immunization. Patient's medical history was not reported. Concomitant medications included losartan, Norvasc (amlodipine besilate), ezetimibe. The patient did not receive other vaccines in four weeks. Prior to vaccination patient did not have COVID-19 and was not tested post vaccination. On 13Feb2021 at 04:30 AM, the patient experienced off balance, slight nausea, slight headache and not feeling well. NO treatment was received for events occured. Outcome of events was recovering. Information on the lot/batch number has been requested.

March 27,28,29 Severe diarrhea, foggy head. March 29 Altered mental status, symptoms of stroke, loss of memory for short period of time, diarrhea,headache-recurrent. Low sodium levels

March 21 was supposed to be the "end" of the final period after my 2nd shot -- On March 21st I started developing aching muscles, joints and neck and waves of nausea along with intermittent muscle wekness & extreme fatigue. It became worse on the 22nd & 23rd so for safety on the 24th I had a "nasal Covid-19 test" done at a Urgent Care facility to determine if I had possibly contracted the Covid-19 virus. The test came back 'negative' -- I did not have an active case of Covid. The symptoms I was experiencing finally calmed down about Friday - the 26th and by Sunday, they were over. It was almost like a further delayed adverse reaction to my final March 6th 2nd dosage shot although the muscle & joint aches and fatigue were worse than just after the 2nd shot?

Severe cramps and diarrhea 2 days after 2nd shot. Sweaty, lightheaded and achy with shaking chills, but no fever.

high blood pressure , dizziness , blurred vision , nausea saw doctor , was in hospital 4/15-contacted the patient , patient has been feeing much better for some time , no issues now

worsening abdominal pain x 2 weeks which has subsided went to ER on 3/23/21 and received pain patch, tylenol and intravenous muscle relaxer, CAT scan was done on lumbar and abdomen, results were negative. No longer has signs and symptoms at this time.

body aches everywhere; severe headache; bones and joints were hurting so bad she couldn't barely walk much; bones and joints were hurting so bad she couldn't barely walk much; bones and joints were hurting so bad she couldn't barely walk much; Nausea; by 10 her mom had hard cramping, that it started at 8:30 with cramping in her abdomen and severe bloating; bloating; could still void but it was pressure tying to go/severe pain and abdominal pain was causing pain to void; couldn't eat or anything; intestinal cramping/severe gut, lower abdominal, intestinal pain; This is a spontaneous report from a contactable consumer via An 80-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in arm on 04Apr2021 15:00 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Ehlers-Danlos syndrome (states she was diagnosed about 40 years ago), Allergies, lung collapses (due to Ehlers-Danlos syndrome), preemie, no fusion in her eyes (States she sees out of one eye most of the time), does not retain sodium and potassium (related to Ehlers-Danlos syndrome), egg allergy. The patient previous received pneumonia and shingles vaccine for immunization and was fine, the first dose of the bnt162b2 via an unspecified route of administration in arm on unspecified date as single dose for covid-19 immunisation and fine. Concomitant medication included potassium as does not retain potassium; spironolactone; a list of medications. Her mom got her 2nd dose on Sunday and is in the process of needing to report that. She ended up with severe gut, lower abdominal, intestinal pain and bloating along with other normal things. States she saw her doctor yesterday and he believes it could be caused by the Propylene Glycol in the vaccine. Her mother received her shot at 3pm on 4Apr2021 and does not know which arm. Her symptoms started around 8:30 with body aches everywhere, a severe headache, her bones and joints were hurting so bad she couldn't barely walk much, she made it to the bathroom and that was it, and nausea. Caller states by 10 her mom had hard cramping, that it started at 8:30 with cramping in her abdomen and severe bloating. States her mom could still void but it was pressure tying to go and caused severe pain and abdominal pain was causing pain to void. Caller provides that her mom continues the same until Tuesday morning and then the intestinal cramping and bloating is still continuing now and it's more primarily her lower left area as of Wednesday. She has a big history of Ehlers-Danlos syndrome and her doctor that she met with yesterday feels this is probably from the propylene glycol component that caused the flare up, as she usually doesn't have this and he is hoping it will calm down in about a week. Her mom also couldn't eat or anything until Tuesday. She was down all of Sunday night and Monday for about 36 hours. Stated the voiding is somewhat better but not much better and the rest of the symptoms are consolidated and persisting. Reporter stated her mom can't go without her medications. Her mom did a virtual doctor visit and will follow up later this week. Her mother got the second dose of the vaccine and had severe intestinal pain, headache, joint pain, nausea, abdominal pain. The outcome of the event Dysuria was recovering, Unable to eat was recovered on 06Apr2021, other events was not recovered. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

soreness; her bowels were a little iffy; Feeling Ill; rumbling bowels; diarrhea; upset stomach; nausea; vomiting; accelerated heart rate; dizziness; fever; chills; This is a spontaneous report from a contactable consumer. A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK8730; Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 14:45 at SINGLE DOSE for covid-19 immunisation. Medical history included arthropod sting, hypersensitivity, sinus disorder, hypertension, blood cholesterol, covid-19.C oncomitant medications included fluticasone taken for hypersensitivity, sinusitis; hydrochlorothiazide, lisinopril taken for hypertension, simvastatin taken for blood cholesterol. The patient previously took z-pak. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No visit to emergency room and physician office. No patient's medical history (including any illness at time of vaccination), relevant tests and family medical history. On 25Mar2021, the patient experienced had minimal soreness, no discomfort, 26Mar2021, she awoke with accelerated heart rate, upset stomach, rumbling bowels, and ran to the bathroom and vomited. Then she had diarrhea. Eventually her heart rate slowed, it was elevated for a while and slowed to normal that morning. she had 6-7 episodes of each- the vomiting and the diarrhea. In between those episodes, she had chills, dizziness, then fever. It rolled along, then her heart rate gradually slowed down. Her symptoms stopped after 2-3 rounds of diarrhea episodes. Her chills came on after she experienced accelerated heart rate. The chills stopped after the first or second throwing up/diarrhea episodes. She had brief dizziness following that. She had a couple or one more episode of throwing up and diarrhea. She got warm, calling it a fever and it did not last long. She has a tendency to get dizziness and takes Flonase to keep her allergies at bay. She thinks the dizziness this time went along with her chills and fever. On 27Mar2021, her stomach had a little discomfort, but nothing major. On 28MAr2021, 02:45 she awakened feeling ill and though she might vomit. It ended up being diarrhea and had 3 episodes of that, spaced out. It was over at 09:00. On 29Mar2021, her stomach was queasy and it went away by evening. On 1Apr2021, she had been experiencing tummy aches, taking Tums and her bowels were a little iffy. Therapeutic measures were taken for dizziness with Flonase. The outcome of the events nausea, vomiting, diarrhea, upset stomach, soreness and abdominal discomfort were unknown and events accelerated heart rate, dizziness, fever, chills and illness were recovered. No follow-up attempts are needed. No further information is expected.

Severe diarrhea for three days, Extreme swelling of stomach. Extreme abdominal pain. Additional swollen area on left side of intestines. Shingles like pain in abdominal skin and flesh.

feeling very, very dizzy/dizziness; diarrhea; This is a spontaneous report received from a contactable consumer. A 80-year-old female consumer (patient) received first dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE, solution for injection), (Batch/lot number: EL3249) on 20Jan2021 at single dose for COVID-19 immunisation. The medical history of the patient included genito arthritis and asthma. The concomitant medication was not provided. On 20-JAN-2021 patient was feeling very, very dizzy and diarrhea. Patient was concerned about diarrhea as she got a shot 20Jan2021 and on 27Jan2021 she was still experiencing diarrhea. The patient took the vaccine on last Wednesday and had side effects or dizziness and 2 days later I started with diarrhea which is going on now. Patient did not received any treatment. Patient had some blood work done. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.

hands are tingly; My hands are tingly and so cold.; felt terrible everyday; Nauseated; Arms felt like they were asleep; so sick; Hurt all over; not moving too fast; I do not want food; I have not eaten, taken a shower or anything; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 09Feb2021 09:45 (at the age of 80-years-old) as SINGLE DOSE for covid-19 immunisation. Medical history included immunodeficiency, atrial fibrillation. The patient got her shot last Tuesday morning at 9:45 and had been real sick after this. The patient had a bad reaction to it. Well after patient got the shot it was in the. And it said if she was on blood thinner (Unspecified Medications) or 'immune disorder' (not clarified further) she know and she was both of those and was just wondering what to expect and today from elbow. On unspecified date of Feb2021 , her arms felt like they were asleep and then now it was from elbow bit down and her hands got real cold. Now she had not ran a fever and she had not vomited, but she did not want food. She had hurt all over and she had been nauseated (on unspecified date of Feb2021) but not vomited. She had not eaten, taken a shower or anything, and she had been so sick (on unspecified date of Feb2021). Well let her see if she could see a pen that writes. She was not moving too fast (on unspecified date of Feb2021). She wanted to know if this was going to affect her blood, the thickness or the firmness. Since Tuesday, 09Feb2021, patient hands were tingly and so cold. The patient had felt terrible everyday. She had other relatives that got some aches and fatigue , but nothing like what she had. The patient was not currently not taking any immunosuppressant drugs. Patient was enquiring that was it ok to get her 2nd Pfizer vaccine vaccine dose in 4 weeks. The patient also enquiring about was it a problem, with getting the vaccine, if she take Blood thinners, she had atrial Fib and used to get a lot of blood clots. And was there any problem with being immunocompromised and getting the vaccine. Outcome of the events was unknown. Information on batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.

Patient received dose 1 of the pfizer covid vaccine on 1/22/21 and dose 2 on 3/4/21. Patient was diagnosed with COVID on 4/22 at outside clinic after presenting with about a week of cough, nausea and fatigue. On 5/2/21 she presented to our emergency department with persistence of the above symptoms and hypoxia to the 70s on room air and again tested positive for COVID. Initially required BIPAP then HFNC. She was treated with broad spectrum antibiotics for 7 days and dexamethasone for 10 days. She was offered tocilizumab and remdesivir but refused. She clinically improved and was weaned down to 2L NC w/saturation of 93%. However on 5/13 she acutely desaturated and was found pulseless. Patient was DNR/DNI so was pronounced dead.

Patient is an 80 y/o right handed female who is totally independent at baseline who received her Pfizer vaccine out of the country (1st dose 2/19/21, 2nd dose 3/12/21). She was reactive to both shots, reporting arthralgias, headache, low grade fever, chills. She had a rise in blood pressure later during the day of her shot as well as the next day (up to 180/70, from baseline of 130/70). She also had an episode of epistaxis several days after her first shot. She traveled independently out of the country on 3/31/21 to visit her son on a leisure trip. On 4/5/21 she had headache, dizziness/lightheadedness, and did not feel well, and her systolic BP was 198, after which she took additional 40 mg of lisinopril. Her BP subsequently decreased to systolic BP of 130 mm Hg on 4/5/21, but over the next few days she had labile BP with a range of BP of 125 to 171/ 58 - 68. She was meticulous in checking and recording her BP several times a day, and she increased her lisinopril dose to 40 mg po qd from 20 mg po qd given the higher than usual blood pressure range. On 4/10/21 her BP was as follows: 6:30 am, 148/60 (she took her daily lisinopril 20 mg po); 11:30 am: 132/52; 3 pm: 171/69 (she took additional lisinopril 20 mg po) after which her systolic BP decreased to 130. Then around 6:20 pm the same day (4/10/21), she had acute onset of headache, vomiting, left sided weakness, SBP 220, and was witnessed to have rapid change in mental status. There was no antecedent trauma to the head. EMTs were called immediately and she had loss of consciousness during the ambulance ride to the ED, after about 20 minutes of symptom onset, with agonal breathing and bradycardia to the 40s, but never lost her pulse. Upon arrival to the ED out of the country, her Glascow Coma Scale (GCS) was 6, she was rapidly intubated and stabilized. Head CT demonstrated massive intraparenchymal hemorrhage (140 cc) within the R temporal parietal and occipital lobes, with cerebral edema and 14 mm midline shift, associated with small subdural hematoma and small intraventricular hemorrhage within the temporal horn and body of the R lateral ventricle. They reported hyperdense "spot sign" within the intraparenchymal hematoma compatible with active hemorrhage, no evidence of venous thrombosis, no masses, no arteriovenous malformations. She had 2.5 mm aneurysm right that was thought to be incidental finding unrelated to her event. She was taken emergently to the OR on 4/10/2021 for decompressive R hemicraniectomy, which she underwent successfully with minimal blood loss. She had no coagulopathy and her platelets and hemoglobin were normal. She remained in the Neuro ICU for 3 weeks. She received a tracheostomy two weeks after her presentation, and was weaned off the ventilator. She is breathing spontaneously after 5 weeks from presentation. She remains in coma or minimally conscious state, with GCS score of 5-6 as of 5/13/2021.

cut her left thumb right across the top with a cat food can lid; couldn't vacuum because she was so weak.; felt that she needed to lay down because she was so tired; felt like she had the full blown (COVID-19) Virus; regurgitating; nausea hit her like 'bang'; little bit of diarrhea; Weakness; felt deathly ill for a month; vomited up the Cephalexin 500mg; lost 25 lbs. in a month and a half.; very acute bronchitis that hit her after her first COVID-19 Vaccine; coughed and coughed for about 2-1/2 weeks; thought she had whooping cough; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 at 15:30 at the age of 80 years old (Batch/Lot Number: ER8727) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included uterine cancer (uterine cancer at 28 years old, had surgery for the uterine cancer); renal cancer (kidney cancer battled for 8-1/2 years. did not want another surgery, doctors did liquid cobalt treatments); nasal cavity cancer (had surgery to remove the cancer on nose about 7-8 years ago. had big hole taken out of her big Irish Cherokee nose. Thought the cancer was from her cat always hitting her with its claw on that side of her nose), bronchitis ( all her life) , radiotherapy (liquid cobalt treatments) , arthritis in back , kidney infection, pertussis, cytogenetic abnormality (missing half of a chromosome). Concomitant medication included estrogen nos (ESTROGEN NOS) 0.06 mg, 1x/day half of the pill in the morning, taking estrogen since she was 48 years old, meloxicam (MELOXICAM) 15 mg, 1x/day half of the pill at night for three years for arthritis in her back, cefalexin (CEPHALEXINE) taken for kidney infection, start and stop date were not reported. The patient previously took B12 shot every month (no additional information provided. No Additional Vaccines were Administered on Same Date of the Pfizer Suspect. No other vaccines were given within 4 weeks. The patient experienced felt like she had the full blown (COVID-19) Virus, regurgitating, nausea hit her like 'bang', little bit of diarrhea, Weakness, felt deathly ill for a month on 28Mar2021; lost 25 lbs. in a month and a half, very acute bronchitis that hit her after her first COVID-19 Vaccine, coughed and coughed for about 2-1/2 weeks, thought she had whooping cough, vomited up the Cephalexin 500mg on Mar2021; felt that she needed to lay down because she was so tired, couldn't vacuum because she was so weak on 09Mar2021, cut her left thumb right across the top with a cat food can lid on 10Mar2021 Treatment was given for cut on left thumb received 7 stitches in her left thumb on 10May2021 and bronchitis. Relevant Tests were reported as None. The clinical course was reported by the patient as follows patient received her first COVID-19 Vaccine dose on 28Mar2021 at about 3:30PM, and by 6:30PM, she felt like she had the full blown (COVID-19) virus. She stated started regurgitating. The nausea hit her like 'bang' and she had a little bit of diarrhea, and was really weak. She felt deathly ill for a month. Today (10May2021) was one of the first days she got dressed, and was up for the whole day. She said some days, she could not get up for more than an hour or two, and then she would have to go back to bed because she was so weak. Her doctor told her since the second COVID-19 Vaccine dose was supposed to be a little rougher than the first COVID-19 Vaccine dose, he didn't want her to get the second COVID-19 Vaccine dose. She said she was 80 years old, and had always been very self-sufficient. Stated she beat cancer 3 times. The patient called her physician, and her doctor wanted her to go to the hospital but didn't want to go. The doctor told her to take Cephalexin 500mg for 2-1/2 weeks, and then drop down to 1 Cephalexin 200mg nightly. Caller mentioned she kept Cephalexin 200mg and Cephalexin 500mg on hand in case she had symptoms of a kidney infection because she lived in a mountain town, and wasn't close to her doctors office. Since she had a history' kidney cancer she had more kidney infections'. Patient would take Cephalexin 500mg if she was hit hard with a kidney infection, and she would take Cephalexin 200mg is the kidney infection symptoms were just starting. Patient vomited up the Cephalexin 500mg. She said she lived on ginger ale and water. She stated she lost 25 lbs. in a month and a half. She said she was trying to gain back some of her weight now. No further details provided. Patient developed a very acute bronchitis that hit her after her first COVID-19 Vaccine. She clarified she coughed and coughed for about 2-1/2 weeks. She said she thought she had whooping cough, and had no way to stop the coughing. She could not vacuum because she was so weak. She said she went outside yesterday, and was outside for 20 minutes. She said she felt so weak, she went inside and laid down on her couch. She said she fell asleep for 4 hours. She said her weakness was like nothing she ever experienced before. Felt energetic and would start to do something, and then felt that she needed to lay down because she was so tired. She said she would go lay down, and then wake up 4 hours later. She doesn't think she was positive for the COVID-19 Virus. No further details provided. Patient stated she cut her (left) thumb (right across the top with a cat food can lid) this morning. She said the clinic in the valley, put 7 stitches in her left thumb today. The clinical outcome of the events Regurgitating, Nausea, Diarrhea, Vomited recovered; weakness, Ill feeling, Acute bronchitis, cough was recovering, while the remaining events was unknown. Follow up attempts are needed. Further information has been requested.

feeling like I was going to pass out; Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside. Pockets have gone down but are still visible after 6 days.; while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside.; severe hot flashes; chills; felt like I wanted to vomit; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old female patient received first dose of bnt162b2 (BNT162B2 Solution for injection) via an unspecified route of administration, administered in arm left on 12May2021 12:00 (Batch/Lot number was not reported) as first dose, single for COVID-19 immunization. Medical history included obesity, atrial fibrillation, cardiac failure from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took sulphonamides, beta methasone, prilosec. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. The patient was not hospitalized. On 12May2021 at 12:00 AM, Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like large worm inside. Pockets have gone down but are still visible after 6 days. The worst part, was that got severe hot flashes then chills, feeling like I was going to pass out. Then felt like wanted to vomit. This went on for 24 hours, but now has seemed to stop. The outcome of the events was recovering. Information about lot/batch number has been requested.

Swelling and peeling of lips, peeling and soreness inside mouth, Diarrhea, upset stomach ache, dizziness

big itching in the body/strong itching; pain in the back and stomach/hurts in her upper back; pain in the back and stomach/hurts in front of her upper stomach; broke out in rash all over her body; This is a spontaneous report from a contactable consumer or other Non-health care professional. An 80-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Jan2021 as 2ND DOSE, SINGLE for indication of COVID-19 immunization. The patient medical history was not reported. The patients concomitant medications were not reported. The following 4 days patient was fine and after that she described her side effects as big itching in the body, pain in the back and stomach - She went to Hospital and doctors were not able to give any treatment recommendations. She wants to consult with Pfizer about her condition and seek for recommendations. patient broke out in rash all over her body and she was concerned about it. Patient stated that she had a strong itching for three days. Reported that hurts upper back and front of upper stomach. Has insurance and no one answered what she needs. Stated that she is in the shower every half hour. Stated that the itching is bad and she wanted to know what to do. Stated that she is healthy and has no problems and she had the vaccine a week ago and did not have any symptoms until three days ago when the itching started very hard then her back thing and then her stomach thing. Stated that she had no symptoms from the first one. Patient had taken her second dose of vaccine a week ago and did not have any symptoms until three days ago when she experienced, strong itching (pruritis), hurts in her upper back/front of her upper stomach (abdominal pain upper), rash all over her body. Stated that she called Medical Information before and they did nothing. Case number not provided. Outcome of events was unknown. 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.

throat felt very tight; although I could swallow, it felt difficult to do so; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer BioNTech Covid 19 MRNA VACCINE BIONTECH, Solution for injection) (Lot no: 5318) via unspecified route of administration at right arm on 29Jan2021 at 16:30 as single dose for COVID-19 Immunization. Medical history included high blood pressure and high cholesterol. Concomitant medications included Lisinopril, Amlodipine, Pravastatin, ergocalciferol (Vit. D). On 29Jan2021 after 15 minutes of receiving first dose the patient felt that her throat was very tight and although she can swallow, it was difficult to do so. This lasted between 10 to 15 minutes and gradually subsided and did not return afterward. Since the vaccination, the patient had not been tested positive for Covid-19. No other therapeutic measures were taken. Patient did not receive any other vaccine 4 weeks prior to COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was not tested for COVID-19 since vaccination. The clinical outcome for the events throat felt very tight, difficult to swallow was recovered on 29Jan2021. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's First Name added; Postal Code added; Patient's Ethnic Group captured. Patient's Age/Units captured as 80 years per event's onset=29Jan2021. For Relevant Med History: Verbatim "Blood pressure high" updated as "high blood pressure" per source reported. For suspect vaccine: Indication "COVID-19 immunization" captured twice, removed one. All Con-Meds were re-coded to remove from "Obtain Drug Country/Drug Authorization Country" since both fields should be Blank for con-med per SOP. 6. For all events: "Treatment Received?" captured as "No" per verbatim "if treatment ae: No"; Onset updated from "29Jan2021 00:00" to "29Jan2021 16:45" per source reported. Event term "difficult to swallow" updated as "although I could swallow, it felt difficult to do so" per source reported. "None" removed from Concomitant Therapy field since con-meds already coded in Product tab. Initial missed information "administration date=29Jan2021, administration time=04:30 PM", "adverse event start date: 29Jan2021, adverse event start time: 04:45 PM", "known allergies: No"

her heart beats heavy; she did not lay down back in bed; light headedness/ she experienced dizziness; nausea; This is a spontaneous report from a contactable nurse. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL9265) via an unspecified route of administration, left arm on 02Feb2021 at a single dose (at the age of 80 years-old) for COVID-19 immunization. The patient's medical history included vertigo, arthritis, anemic, muscle spasms, high cholesterol quadruple vessel bypass graft and patient concomitant medications included as atorvastatin, cyclobenzaprine. On 03Feb2021 during the night patient experienced dizziness, light headedness, nausea, heart rate abnormal, activities of daily living impaired. Patient's normally her heart beats heavy but that was normal to the patient. The patient had already been diagnosed with vertigo prior vaccination. Patient paperwork stated that it was not recommended to receive the second dose, but patient wanted to know if what patient experienced qualified for her not to take it. The patient known second dose was higher than the first dose. There were unknown investigations done. The labs from last time patient went for them, they were concerned patient LDL was very low and the cholesterol was off, this was about a month ago. The outcome of the events dizziness, light headedness and nausea was recovered. The outcome of the remaining events outcome was unknown. No follow-up attempts are needed. No further information is expected.

severe headache on 2nd day, exhausted for 3 weeks, mild chills, extreme burning in chest, passed within 12 hours, tingling in hands and arms and itching, low blood pressure, sporaitic left arm and elbow pain, lower stomach cramps, diarrhea, out of breath

Constant throwing up and went into a stroke; Constant throwing up and went into a stroke; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EWO151), at the age of 80 years old, in right arm on 02Apr2021 12:45 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). The patient was not pregnant at time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination. The patient received any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced constant throwing up and went into a stroke on 01May2021 10:00. The patient was hospitalized due to the events. The patient had not been tested for covid-19 since the vaccination. Therapeutic measures were taken as a result of constant throwing up and went into a stroke. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

Recommended dose is 0.3 mL. Actually 0.5 mL dose was given but it was the same supplier. Client reports "feeling nausea like I did with the first dose". This was at 4:20 PM on 6/11/21. PHN discussed and client knows to stay hydrated, she is drinking clear soda. She will rest and try to eat a little. PHN discussed COVID s/s and advised client to seek care at ER is symptoms worsen or seem different from the s/s with her first dose.

low grade fever (99.7°F); His wife had a rash on the right side of her abdomen and inner thigh/rash on the right side of hrash on inner thigh of one leger belly/rash on inner thigh of one leg; diarrhea; vomiting/Throwing up; This is spontaneous report from a contactable consumer (patient husband). This report is regarding his wife. A 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/lot number: PHFEEL9263, Expiration date: Unknown), via an intramuscular route in the left arm on 28Jan2021 Thursday at 12:00 PM, as 1 ST DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history included cancer; however, she is cancer-free right now. The patient concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 30Jan2021 until 23:00 or midnight patient was fine, and the patient had experienced heavy 20 minutes being in the bathroom throwing up and having diarrhoea and in the morning rash on the right side of her abdomen about the size of a saucer and inner thigh and on 02Feb2021, a low grade fever (99.7 degree Fahrenheit). Her temperature never went higher than 99.7 degrees. Patient wanted to know if can expect these side effects from the second dose and could they be worse. The patient underwent lab test and procedure which included regular CBC (like whole bloodwork) on 01Feb2021, Monday. She doesn't have any test results to include. The clinical outcome of fever has subsided and outcome for the event rash on the right side of her abdomen and inner thigh of one leg was recovering, outcome for diarrhoea and throwing up was unknown. Follow-up attempts are completed. No further information is expected.

Chills, low fever, nausea, sneezing, runny nose, diarrhea, aching, weakness, unclear thinking, metallic smell and taste- severe at times, slurred speech

Felt weak; Dry throat; States she has noticed she has been burping a lot and coughing harder.; States she has noticed she has been burping a lot and coughing harder.; She has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up; she has been having shortness of breath that started when she got the first dose of the Pfizer COVID vaccine on 27Jan2021; Chills; she just felt tired was all; pain at the injection site in her right arm so she took Tylenol that morning; This is a spontaneous report from a contactable nurse (patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265) dose 1 via intramuscular route of administration in Arm Right on 27Jan2021 at 13:30(at the age of 80 years old) as single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. Patient had no other vaccines on the same day as the COVID vaccine. The patient experienced as, she has been having shortness of breath that started when she got the first dose of the pfizer covid vaccine, chills, she just felt tired was all, pain at the injection site in her right arm so she took tylenol that morning on 27Jan2021, felt weak on 07Feb2021, she has noticed she has been burping a lot and coughing harder, she has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up, and dry throat on an unspecified date on Feb2021. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. The patient underwent lab tests and procedures which included weight: 145-147 on an unspecified date. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. Outcome of the event shortness of breath and chills were recovered and unknown for rest events. Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.

neck felt really weird, her whole neck was hurting; very tired; Fever; pain in the stomach; Dry heaves; back was hurting; no energy; knee hurting; got so sick; delusional; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot: EL2346) via unspecified route of administration on 15Jan2021 09:57 as single dose in arm right for COVID-19 Immunization. Medical history reported was thyroid, blood thinner and degenerative disc disease, all ongoing. Concomitant medications reported was rivaroxaban (XARELTO) ongoing as blood thinner taking for many years, levothyroxine ongoing for thyroid it was 25 and they no product taking for 5 years and prednisone from 21Jan2021 till 26Jan2021 for degenerative disc disease as Blister pack take six, then five, and down to one daily by mouth for six days. No prior vaccinations within 4 weeks was reported. Consumer called to report side effects. Stated she received the first dose of the Pfizer COVID 19 vaccine 15Jan2021 at 09:57AM in the right arm. Six days later all of the sudden in the evening she got so sick with pains in her stomach; dry heaves but she didn't throw up; felt horrible with no energy. She didn't even brush her teeth or undress to go to bed. In the night she had a fever, but she was so sick she couldn't reach overtake her temperature. She heard a voice saying, "what is your temperature". She thought she was delusional. She woke up and her knee was hurting, and her back was hurting. She had a knee replaced in Jul2020 and sometimes has trouble with it. She was diagnosed with degenerative disc disease and the doctor put her on prednisone pack for her back pain. The next day she felt better but her stomach was still bothering her, and she was so very tired. She hasn't been out, and it wasn't like she picked up anything. The next night Saturday her neck felt really weird, her whole neck was hurting. She was tired until Wednesday. Outcome of the event pain in the stomach was recovered on 24Jan2021, Dry heaves recovered on 21Jan2021, no energy, neck felt really weird, her whole neck was hurting was recovered on 22Jan2021, very tired was recovered on 27Jan2021, back was hurting, knee hurting, fever was recovering and for remaining events its unknown. Follow-up attempts are completed. No further information is expected.

dizziness; nausea; headache; This is a spontaneous report from a contactable female Nurse (patient). A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot Number: EN5318) via an unspecified route of administration on 06Feb2021 11:45 as dose 1, single for COVID-19 immunisation. The patient medical history included ongoing high blood pressure had this for years, ongoing high cholesterol, ongoing allergies had for at least 20 years, perennial allergy from an unknown date and unknown if ongoing she has perineal allergies. also, she has an allergy to penicillins and erythromycin with penicillin being an anaphylaxis reaction. Caller has no NDC, Lot, or Expiry for any of the products which caused these reactions, this was a long time ago, cancer from an unknown date and unknown if ongoing, swine flu from an unknown date and unknown if ongoing AE(s) following prior vaccinations: In the 1970's with the swine flu, she was given the vaccine and right after she felt like she was going to pass out. EMS gave her oxygen, and she was fine. No NDC, Lot, manufacturer, or expiry. Concomitant medications included lisinopril (LISINOPRIL) 40 mg taken for an unspecified indication, start and stop date were not reported; montelukast (MONTELUKAST) taken for an unspecified indication, start and stop date were not reported. No prior Vaccinations within 4 weeks. On 06Feb2021, less than 48 hours ago the patient experienced after she had the first shot, she has had a headache and mild nausea for 2 days. On 08Feb2021, this morning she has been very dizzy and so she was wondering if this was normal; she didn't see it on the side effect list, but I am not having weakness or anything really bad and asked if this dizziness could be from the COVID-19 vaccine. When she eats, she feels sick to her stomach, in regard to the nausea. She gets a flu shot every year and has never had a problem. The clinical outcome of the events was not resolved. Follow-up attempts completed. No further information expected.

sore arm; tired; headache; throw up; This is a spontaneous report from a contactable consumer, the patient. A 80-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) into left arm on 19Mar2021 at 10:30 (at the age of 80-years-old) as single dose for COVID-19 immunisation. The patient's medical history included open heart surgery. The patient's concomitant medications included atorvastatin 20 mg (MANUFACTURER UNKNOWN), levothyroxine 100 mcg (MANUFACTURER UNKNOWN) for and multivitamins (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date. The patient had an allergy towards amoxicillin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been diagnosed with COVID-19. On 20Mar2021 at 07:00, the patient experienced sore arm, tiredness, throw up and headache. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, tiredness, throw up and headache was recovered on an unknown date. No follow-up attempts possible. No further information expected.

Systemic: dysgeusia-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: dysgeusia at onset followed by vomiting 3 days pater precipitating a trip to er and subsequent rx for ondansetron

I was having side effects during the vaccine a headache and then nausea, throat soreness, face redness, neck redness, rash on chest. Pain in lower abdomen. Pressure around left ankle.

Chills; Temperature of 100.8F; Diarrhea; Nausea; Fatigue; she was sick; blood sugar got up to 258; This is a spontaneous report received from a contactable consumer (Patient). A 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left upper arm on 26Feb2021 at 11:15 (at the age of 80-year-old) as a single dose for covid-19 immunisation. The patient medical history included ongoing diabetes mellitus (diagnosed 25 yrs ago. She was keeping control with medication and started insulin in Jun2020), arthritis, pain, ache, blood pressure, blood sugar and blood cholesterol (abnormal). Patient did not receive any prior vaccinations within 4 weeks and did not experienced any AEs following prior vaccinations. Concomitant medications included paracetamol (TYLENOL, once a day, started it probably 10 years ago) taken for arthritis, meloxicam (15mg, tablet once a day by mouth, has been taking for 5-6 years) taken for aches/pain, enalapril (20mg twice a day tablet by mouth) taken for blood pressure (abnormal), glipizide (10mg, 1 tablet in the morning and 1/2 a tablet in the evening with meal by mouth) taken for diabetes mellitus, saxagliptin hydrochloride (ONGLYZA, 5mg once a day by mouth, started about 2 years ago) taken for diabetes/to help with blood sugar, atorvastatin (40mg, once a day, by mouth, started taking it years ago) taken for blood cholesterol, insulin (10units once a day, injection, subcutaneous) taken to control her blood sugar/diabetes from Jun2020 and paracetamol (TYLENOL ARTHRITIS, 2 tablets a day by mouth, started it 10 years ago) taken for arthritis and all were ongoing. The patient family medical history relevant to AE and pertinent details (Include surgical procedures and dates) was none. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809) administered in left upper arm on 05Feb2021 (at the age of 80-year-old) as a single dose for Covid-19 immunization. On 27Feb2021 at 13:30, the patient experienced chills, temperature of 100.8 F, diarrhea, nausea, fatigue (she could not even get out of bed) and when she was sick her blood sugar got up to 258 and on sunday (28Feb2021) came back down to 96. Chills ended 9 hours after they started, and she was back to normal. Patient received 2 regular Tylenol as a treatment for the events. Patient did not visit emergency room or physician office due to adverse events. The outcome of the event sick was recovered on an unspecified date in 2021, diarrhea, fatigue, her blood sugar got up to 258 was recovered on 28Feb2021 and rest of the events were recovered on 27Feb2021. No follow-up attempts are possible. No further information is expected.

Diarrhea for several days, Swollen face, shooting nerve pains in face and head, face painful to the touch, as if nerves inflamed. Doctor suspected shingles, but no blisters appeared. Pain stopped after five days. Swelling lasted a couple of weeks. Irritated nerve sensation in trunk persists,

both forearms ache; chest felt heavy; lips swelled; eyelids drooped; hands were weaker than usual; whole right side was weak; she could not eat; could not digest food; Lost weight; she got continual heartburn and burped throughout the day after she ate; felt burning; Her stomach was knotted, she could feel her stomach closing up on her; Her stool was mush for the whole three months, it finally got to droplets that turned to mush.; it affected her digestive system and her release of the stools.; Her forehead was very much wrinkled; has a lot of food intolerances and it is not new that she is intolerant; This is a spontaneous report from a contactable consumer or other non hcp. An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration, administered in Arm Left on 01Mar2021 (at the age of 80-years-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She does not take pills. She takes vitamins but states that does not count. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9262) via unspecified route of administration, administered in Arm left on 08Feb2021, in the morning around 9:30 or 10am (at the age of 80-years-old) as dose 1, single for covid-19 immunisation. It was reported that she thinks she should report the difficulty she had with the vaccine since it was not the usual adverse reactions and it was extended. She went to doctor several times. She was wanted to know how to deal with it. Clarifies she does not have a question since this was no longer part of her system. She woke up every morning between 05:30 and 07:00 am and was awoken by both forearms aching. Then it got to where the right forearm ache was worse than the left. Sometimes she felt burning. Her chest felt heavy. Her lips swelled. Her eyelids drooped; left eyelid drooped more than the right eyelid. Her whole right side was weak. When she wrote her right hand was weaker than usual. The worst reaction was that she could not eat, she could not digest food, her digestion was completely off. When she went to doctor, she weighed 92 pounds since she got continual heartburn and burped throughout the day after she ate, and this continued for hours. She had to make special food for herself since she could not digest/ eat most food. She ate fish, bread, and potato. She could not digest anything heavy. Her stomach was knotted, she could feel her stomach closing up on her. She was fearful of eating. Her stool was mush for the whole three months, it finally got to droplets that turned to mush. The main thing as she said, it affected her digestive system and her release of the stools. She lost 8 to 10 pounds. She kept a diary of her food and feelings for months. Her forehead was very much wrinkled, she has wrinkles anyways since she was old, but she had wrinkles in her wrinkles. She had a lot of food intolerances and it was not new that she was intolerant. Her body had many intolerances such chocolate, lactose, nuts, and some medications. She cannot eat anything with any chemicals such as msg and yellow food dye. She cannot eat deli meat since it contains some chemical. At first, she didn't realize it and did not know what was going on with her body, she noticed the side effects mentioned above more after the second dose which was given on 01Mar2021. It took three and half months and finally went it all went away, recovered completely. The patient was recovered from all the events on an unspecified date. No follow-up attempts required. No further information expected.

Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 80-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in arm on 07Apr2021 (at the age of 80-year-old) at dose 2, single for covid-19 immunisation. Medical history included hysterectomy (Additional Information: Done when the caller was 31 years old). Concomitant medication included omeprazole (OMEPRAZOLE) at 20 mg; lisinopril (LISINOPRIL) at 20 mg once a day taken for blood pressure measurement; acetylsalicylic acid (ASPIRIN 81) at 81 mg once a day; calcium (CALCIUM) at once a day; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). The reporter was taking 20 mg of the Omeprazole and then her doctor increased it when the diarrhea started. Lot, NDC, and expiration date unknown. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, on 17Mar2021 (at the age of 80-year-old) at dose 1, single for covid-19 immunisation. No reaction on previous exposure to vaccine. On 09Apr2021 the patient experienced diarrhea. Adverse event led to physician office visit. The reporter is calling about the Pfizer covid vaccine. On 17Mar2021 the reporter had her first shot and everything was fine afterwards. On 07Apr2021 the reporter had her second dose, she was in at the time. 2 days after the second shot the reporter got diarrhea when they were leaving to come back and it wasn't very pleasant. The reporter had the diarrhea for 4.5 weeks. The reporter went to her doctor after having the diarrhea for 2 weeks and the doctor started her on rice and all sorts of things, some diet. The reporter was sticking to the diet and it didn't do any good. The reporter doctor referred the reporter to the colonoscopy doctor. The reporter had the colonoscopy last Friday and they found nothing. The reporter felt like the diarrhea came from the shot. The diarrhea left after 4.5 weeks and then 2 weeks after that, the caller had the colonoscopy. Event: The caller clarifies and confirms that before the colonoscopy the diarrhea has stopped probably a week and a half prior. First Dose: Received 17Mar2021, lot EP7534, unknown expiration date and NDC. Second Dose: Received 07Apr2021, lot EW0151, unknown expiration date and NDC. Investigation: The reporter had routine blood work done a couple of days ago and said it was fine. The reporter would not get a booster shot if we offered it because she doesn't want to go through this again. The patient underwent lab tests and procedures which included Blood work: normal on an unspecified date, colonoscopy: normal on 18Jun2021. Description of Product Complaint: The reporter was taking 20 mg of the Omeprazole and then her doctor increased it to 40mg when the diarrhea started. Lot, NDC, and expiration date unknown. Outcome of the event was resolved on an unspecified date in 2021.

Losing balance, leaning to one side; Diarrhea; Pain in legs cannot stand, pinching like small animals in body; Pain in legs cannot stand, pinching like small animals in body; Can barely walk legs hurt so much; Feels like she is dragging one leg; Itchiness on body; Feeling quite weird; This is a spontaneous report from a contactable consumer or other non hcp. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 1st dose. An 80-years-old female patient received BNT162b2 (Pfizer Covid Vaccine, Solution for injection, lot number: EN0196, NDC and expiry date was unknown), via an unspecified route of administration, administered in Arm Left on 27Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN0164), via an unspecified route of administration, administered in Arm Left on as 07Jun2021 as 1stdose, single for covid-19 immunisation. Medical history included deep vein thrombosis from an unknown date and unknown if ongoing Verbatim: DVT Thrombosis Right Leg. There were no concomitant medications. The patient experienced itchiness on body on 27Jun2021 with outcome of recovered , feeling quite weird on Jun2021 with outcome of unknown , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , can barely walk legs hurt so much on Jul2021 with outcome of not recovered , feels like she is dragging one leg on Jul2021 with outcome of not recovered , losing balance, leaning to one side on an unspecified date with outcome of unknown , diarrhea on an unspecified date with outcome of unknown. Outcome of the events experienced itchiness on body was re-covered, feeling quite weird, losing balance, leaning to one side diarrhea was unknown, pain in legs cannot stand, pinching like small animals in body, pain in legs cannot stand, pinching like small animals in body, can barely walk legs hurt so much, feels like she is dragging one leg was not recovered .

Nausea; Diarrhea; Mild headache; This is a spontaneous report from a contactable consumer (patient herself). This 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 30Dec2020 at single dose for COVID-19 immunisation. No relevant medical history was provided. Relevant concomitant medications included sertraline, levothyroxine and furosemide. Facility where the most recent COVID-19 vaccine was administered was Nursing Home/Senior Living Facility. Age at vaccination was 81-year-old. No other vaccine was received in four weeks. On 01Jan2021 at 12:00 AM, the patient had nausea, diarrhea and mild headache. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Dizzy; Nauseous; Unable to breath; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot unknown, via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunisation. Medical history included blood pressure increased. Concomitant medication included sertraline (UNKNOWN MANUFACTURER) for high blood pressure. On an unspecified date the patient experienced dizzy, nauseous and was unable to breath. The patient still had those symptoms and was wondering if it was normal and how much longer will these symptoms be. The outcome of the events was not resolved. Information about lot/batch number has been requested.

12/28/2020: generalized weakness and fell twice at home, cough, nausea,1/04/2021: cough, nausea, fever and chronic pain when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on bipap, 1/15/2021: pt was intubated, on TPN, pt DNR, 1/18/2021: was extubated and put on comfort measures and passed away

Resident became hypotensive, chest pain, low O2 SAT, diaphoretic, body aches, fatigue and chills on 1/14/21. Second episode on 1/15/21 of nausea, body aches and lethargy.

weakness/feeling weak; Dizziness/head was dizzy; nausea; Neck was sore; discomfort; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231, Expiry Date: Apr2021), via an unspecified route of administration at right arm on 08Jan2021 13:00 at single dose for covid-19 immunization. Vaccine was not administered at military facility. Vaccination facility type was health department. The patient got the flu shot every year and never had a problem. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021, the patient experienced severe dizziness/head was dizzy, feeling weak, nausea, neck was sore. The events did not require a visit to emergency room or physician office. She was very dizzy and laid back down. Today (14Jan2021) was better but she felt weak and wanted to figure out what was going on. She took it to make sure she felt better but the only thing she's had was discomfort. No treatment, not contacted the doctor. The outcome of events weakness/feeling weak, dizziness/head was dizzy was recovering. The outcome of events nausea, neck pain was not recovered. The outcome of event discomfort was unknown.

fast heartbeat, dizziness and it took about 45 minutes to feel better. Had a bad taste in her mouth received Gatorade. On Saturday I felt nausea and just not feeling good and terrible taste in her mouth. Denies any shortness of breath during this entire time. Needed to eat to make her stomach to feel better, chills. injection site sore. Sunday felt better and Monday was almost normal and Tuesday no complaints.

She was cleaned out, pretty much cleaned out of her bowels, but she kept getting pains and started passing blood clots; She kept getting pains; Bad stomach cramps; Diarrhea; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date unknown), via an unspecified route of administration, on 14Dec2020 10:00 at a single dose for COVID-19 immunization. Medical history included hypertension from an unknown date. Concomitant medication included atorvastatin, losartan, alprazolam, mirtazapine, and several medications because of her age and she has hypertension. The patient had her vaccine on 14Dec2020 at about 10 o'clock and a couple of hours later she began getting really bad stomach cramps and had diarrhea for most of the day and about 11 o'clock of 14Dec2020 she reported she was cleaned out, pretty much cleaned out of her bowels, but she kept getting pains and started passing blood clots. Treatment for the events include Some Pepto-Bismol (as reported). The outcome of the event "bad stomach cramps" was not recovered, and for other events was unknown.

Cough (mild - no trouble breathing) & Diarrhea 1.30 / chills 1.31 / leg & back pains 1.31-2.1 / continuing cough

arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site; nauseous/nauseated; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via an unspecified route of administration, on 13Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included COPD (chronic obstructive pulmonary disease) and diabetes and cancer surgery. The patient has unspecified concomitant medications ("she takes many"). The patient experienced being nauseous/nauseated when she got up this morning (25Jan2021). And her arm below the injection site was swollen, red and hot; it was about 2 inches down below injection site. The patient underwent unspecified lab tests and procedures on Dec2020, results were also unknown. Patient took Tylenol as treatment to the events. Outcome of events was not recovered. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.

Dull abdominal pain, all-over achiness, fatigue on day after 2nd vaccination. Around 2 a.m. (36 hours after vaccination), severe stabbing pains radiating from colon up through ribs on left side. Only shallow breathing possible; any more than that brought unbearable pain. Took 10 mg. of Bentyl and another 10 mg about an hour later. Pain subsided in less than an hour after 2nd dose. Discomfort & occasional sudden pain in abdomen, along with achiness, through the next day. Continued to take Benadryl. Dr. reachable by phone only said this probably not a repeat of the diverticulitis I have had several times over the past 15 years but simply spastic colon. By 3rd day, only mild abdominal distress & mild fatigue. I do not know whether this experience is related to the vaccine at all. I had no difficulties after the 1st Covid vaccine.

Following the vaccine, the patient reported feeling "loopy" and a "little nauseous" about 20 minutes after vaccine was given, and attributed this to likely not having eaten earlier. The patient was found not to be diabetic and was given some crackers, juice and water. She was offered to go to a private room for further monitoring, but declined. Her condition did not improve, so she was taken to a private room for monitoring and observation at about 2:30PM. Vitals were taken, she was still feeling poorly and had very high blood pressure (>200 systolic). She declined the ED. At 2:40PM, her blood pressure did not decrease, so the ED was called to take her in, and she agreed.

Patient was flushed and sweating, seemed to be a little dizzy. Vitals were all okay and within normal limits (BP, glucose, O2 Sat, HR). I administered a Benadryl 50mg IM injection to the patient, and the hospital staff later gave her a dose of Zofran as she felt nauseous. Since then the patient seems to be reacting well to treatment.

the arm was very sore all the way down to her elbow; Queasy; pasty frequent stool; pasty frequent stool; the outside of her arm where the vaccine was put hurt that day; This is a spontaneous report from a contactable consumer. A 81-year-old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL1284), at single dose into the left arm on 16Jan2021 at 12:30PM for COVID-19 immunization. Concomitant drugs included Levothyroxine 0.100mg once daily by mouth taking for years for thyroid and a week and half before the vaccine administration, she had a cortisone shot in her hip for bursitis but it didn't work, it was the first time she has had one in a long time. The patient reported that on 16Jan2021 the outside of her arm where the vaccine was put hurt that day, but then the next day the arm was very sore all the way down to her elbow. But it was bad, she couldn't roll in bed form the pain. Then she woke up on 17Jan2021 queasy like morning sickness that didn't go away until 21Jan2021. Adds she also noticed that day she was having more frequent and pasty stools. Mentions she expected her arm to be sore because with the second shingles vaccine her arm was sore. States this was years ago and she did not have any product or information for the shingles vaccine. The patient is scheduled for the second dose on 06Feb2021. Mentions she lives in a continuous care facility and they will give her the shot. The event arm hurt recoverd on 20Jan2021, the other events resolved on 21Jan2021.

Dizzy; Headache; Joint pain; Fever; Injection site swelling; heartbeat would accelerate for a few seconds; Chills; off balance; throwing up; she could not drive and was half delirious; I am not feeling good; sneezing; has no energy; her bowel movement was little dab and then again another little dab; if she does not blow her nose, it feels like something is going down the back of her throat; She still has a punchy feeling; she does not have her peripheral vision right; Her arm felt like a boil where they gave her the shot.; Her arm is still is sore; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982, Expiry Date of Pfizer covid vaccine: May2021), intramuscular injection in left shoulder on 21Jan2021 13:00 at single dose as preventative, since she did not want to get COVID again/there was a new strain of COVID that was easier to catch. Medical history included ongoing high blood pressure diagnosed about 5 to 7 years ago, ongoing high cholesterol diagnosed about 5 to 7 years ago, thyroid disorder, Supplementation, for bones, COVID-19 from Nov2020 to Dec2020: She had COVID in Nov2020 till the end of Dec2020, and she was getting better. Concomitant medication included ongoing metoprolol tartrate for high blood pressure, ongoing simvastatin for cholesterol, ongoing levothyroxine for thyroid, ongoing colecalciferol (VITAMIN D) as Supplementation, for bones. The patient experienced chills, off balance, dizzy, headache, joint pain, fever, injection site swelling, heartbeat would accelerate for a few seconds on 21Jan2021, throwing up in Jan2021. The patient spent that whole night getting up and down and going to bathroom for bowel movement, and her bowel movement was little dab and then again another little dab. She was throwing up by 3am or 4am that night, she threw up twice and reports it was like bubbles. Her side effects started Thursday night. She experienced chills, joint pain, fever, injection site swelling, her heartbeat every so often would accelerate for a few seconds. She dizzy and off balance when she would get up to go the bathroom. Since then she still had sneezing and she was blowing her nose, and if she did not blow her nose, it felt like something was going down the back of her throat. She wanted to ask how long she would experience the side effects and how many people had a problem with the first dose. She still had a punchy feeling, had no energy. She could lay down and fall asleep at almost anytime. Height: about 5'2'', she jokingly stated she was shrinking monthly. Her chills started Thursday night and by Saturday morning they were completely gone. When she tried to turn a corner and reported she did not have her peripheral vision right since she kept running into door frames. She was a little better, sometimes she could walk a straight line and sometimes she veers. Headache was ongoing. She did not have it today, it was not a severe headache, it was more irritating than severe. Her arm felt like a boil where they gave her the shot. Her fever went away Saturday night or Sunday morning. She felt like she was not in her own mind, like she was drifting, so time lines for side effects are hard to recall. Her arm was still was sore. Heartbeat would accelerate for a few seconds was occasionally still happening, it happened last night. She called the hospital (facility where it was received) back the next morning and she was told she could come if she wanted to but it was suggested to stay home and sleep it off. She told them she could not drive and was half delirious, she was told she could call an ambulance to come get her. She confirms she did not call ambulance or go to the hospital. When querying indication, she was told there was a new strain of COVID that was easier to catch. The outcome of events chills was recovered on 23Jan2021, vomiting was recovered on 22Jan2021, joint pain was recovered on 24Jan2021, fever recovered in Jan2021. The outcome of events balance impaired NOS, dizzy, vaccination site swelling, Peripheral vision defective was recovering. The outcome of event headache, sneezing, feeling of total lack of energy, feeling abnormal, sleep excessive and pain in arm was not recovered. The outcome of rest events was unknown.

I am an RN and know that side effects are usually headache, elevated temp, and fatigue. I had the temp (not much as I take Tylenol for arthritis tid) and fatigue but my other symptoms were gastrointestinal. Epigastric distention, abdominal pain and nausea. It was over in approx. 12 hours. I had similar but more severe symptoms last April that I thought were food poisoning. Now I wonder if they were COVID-19 related.

experiencing severe diarrhea have been taking non diarrhea tablets it clears it up for about a day and the diarrhea returns. Im experiencing dehydration as well.

Awakened at about 1:00 A.M with painful arm. Pain has continued until now. Also chills and nausea. Fever reached 100, subsequently dropping to 98.

My blood/glucose level was abnormally high for two days following the vaccine My diabetes symptoms were more prevalent( thirst, frequent urination, dry mouth, diarrhea)

FLU LIKE SYMPTOMS: CHILLS, BODY ACHES, HEAD ACHE, STOMACH PROBLEMS, DIARREA LASTED 3-4 DAYS. TOOK OTC FOR DIARREA - TYLENOL FOR BODY DISCOMFORT. SLEPT FOR MOST OF THESE DAYS .

Started upon rising from sleep on morning after vaccine. Very dizzy, needed help to bathroom, began dry heaving, did not feel sick to my stomach. Dry heaved 3 different times, then vomited 2 times. Still Dizzy. My roommate called ambulance and I had just finished vomiting as they arrived. My blood pressure was 227/70. They monitored me for a while until my blood pressure was at 160/72. I opted not to be taken to the hospital at that time. I ate a slice of toast, which stayed down, them took my morning medications. They also stayed down. I had liquids all day and some crackers. Was dizzy all day. Blood pressure before retiring was 150/74. Slept well last night and am still a little dizzy yet today, but appetite has returned. Blood pressure is now 135/74. which is about my normal.

diarrhea and it was just all bright red fresh blood/bright red blood with diarrhea; bright red blood coming from her anal area; feel heaviness, she just feels that heaviness.; she lost weight; This is a spontaneous report from a contactable consumer (patient). A 81-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EM9809) (at the age of 81-years-old), via an unspecified route of administration on 06Feb2021 between 12:30 and 1PM as a single dose for covid-19 immunization. The facility where COVID-19 vaccine was a doctor's office and administered anatomically located on the right arm. The patient medical history included: She has been diagnosed years ago 10 years ago, which was since she smoked with COPD and she is on breathing medication, but she has not had it due to getting in a donut hole with insurance and she cannot afford it, her hands also won't let her use it, She hasn't had it for 2 months. Arthritis. She has had no other vaccines on the same day or in the past 4 weeks, she had the flu shot back in Oct2020. Family Medical History: Her dad had heart problems and cancer. Her brother had cancer. Her mother had heart conditions. Concomitant medications included: Acetaminophen and Naproxen sodium. She was taking a lot of acetaminophen and Naproxen sodium for arthritis pain, but she has not had any since Friday night 05Feb2021. She did not want to take anything before the shot. She hasn't been weighed in a while, she lost weight. On 06Feb2021, at 8 o clock on the night, she experienced bright red blood coming from her anal area; then, she had diarrhea and it was just all bright red fresh blood, it was fresh new blood not dark at all. Today she is still having bright red blood with diarrhea; the blood seems like it is decreasing, it's being colored by diarrhea. She felt maybe in so many years is like when you have a period at times and feel heaviness, she just feels that heaviness. Caller reports that she does have a standing appointment with her provider tomorrow. The clinical outcome of the events bloody diarrhea and anal bleeding was not recovered, heaviness and weight decreased was unknown. She is scheduled for the second dose on 10Feb2021.

check her own self with her hand and it was like she put her hand on a stove; Allergic reaction; felt bad after taking the first dose-flu like symptoms /achy like flu symptoms; had high fever/feverish; urine became yellowish-brown; had a little diarrhea symptoms; get sick; vomiting; has a really bitter taste, or no taste in her mouth/ her mouth still has that nasty, old bitter taste that does not go away with brushed teeth; has a really bitter taste, or no taste in her mouth/ her mouth still has that nasty, old bitter taste that does not go away with brushed teeth; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program Pfizer First Connect. An 81-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; manufacturer reported as Pfizer-Wyeth; lot number: EL1283; expiration date: unknown), via an unspecified route of administration left arm on 21Jan2021 12:30 at 0.3 mL, single dose for covid-19 immunization. Medical history included arthritis in back; always had diarrhea because she had cancer and is unable to control her bowels. They tell her she has a lot of fiber in her food; but she can't control it; if she eats vegetables then she knows what's happening; but she always tries to take Imodium A-D before eating vegetables. She mentioned to them if she did not eat vegetables all she could eat is meat and cheese; doctor told her she was borderline diabetic, so she has wanted to keep up with that. The doctor was not worried about it; ongoing acid reflux; pain; and ongoing high blood pressure. Concomitant medication included ongoing omeprazole for acid reflux, ongoing amlodipine for high blood pressure, naproxen for arthritis in back, caffeine, codeine phosphate, paracetamol (ACETAMINOPHEN WITH CODEINE) for pain, loperamide hydrochloride (IMODIUM A-D) for diarrhea. The patient has not received any other vaccinations within four weeks prior to the first administration of the covid-19 vaccine. Vaccinations reported as she has gotten flu shots and pneumonia shot and has never had any adverse events, reactions or problems with those; nothing. The reporter mentioned that she got her first dose of the vaccine in a clinic on 21Jan2021 and aware that the second dose will be on 16Feb2021. The patient reported that she felt bad after taking the first dose-flu like symptoms on 23Jan2021 at 8:00 and had high fever Saturday (23Jan2021), urine became yellowish-brown and wants to know more information. The patient guesses she is having an allergic reaction on 23Jan2021 at 8:00 and asked for further information about the allergic reaction relative to the vaccine. On Saturday (23Jan2021), she was feeling good. She got up, went to store, came back and had little diarrhea symptoms then she began to get sick, feverish. She added that then the vomiting, then achy like flu symptoms. She still feels feverish, she has a really bitter taste, or no taste in her mouth really but it's going away. To her it seems like the worst part is over. She almost called 911 but then did not want to go the hospital because of all the people with COVID in the hospital. The next day on 24Jan2021, when she woke up, she was not as fevered. She can check her own self with her hand and it was like she put her hand on a stove. She went to sleep and the next morning (24Jan2021), she was not as feverish; her mouth still has that nasty, old bitter taste that does not go away with brushed teeth. She feels better today (unspecified date). She mentioned that the second dose is scheduled to be administered 16Feb2021, but she really does not want to go get that if she feels like this. She had blood work for her sugar done on 21Jan2021 because she is borderline diabetic, but results are unknown, have not had any results yet. The outcome of the events was recovering.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Seizure-Severe, Additional Details: The incident happened at COVID clinic. Patient was recieving the 2nd dose of the vaccine. The first time we administered the vaccine to the patient, she informed the immunizer that she had a bad cough for 3 days. The patient did mention that she suffers from seizures often. The 2nd dose was administerd by the RPH immunizer and was directed to the waiting area for 15 minutes. During that time in the waiting area, she was talking to the.

Patient called the pharmacy stating that she had a fever (101 F), diarrhea, and a sore arm after receiving her second Pfizer COVID-19 vaccine on 2/26/21

SQUESSING SENSATON IN HEAD AND DIZZY WHEN MOVED HEAD SLIGHTLY' . DIAHREA STOMACH ACH AND SLEPT HOURS AND HOURS AND WEAK.

Patient felt short of breath, lump in throat w/ difficulty swallowing, head ache & dizziness. Vitals 220/120, tachycardia, 98% on RA Treated w/ Benadryl 50, Pepcid 40 prednisone 60

blood clot; death cause: Heart Problems; tired; nauseous; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3248), via an unspecified route of administration at single dose in the left arm on 19Jan2021 14:00 for covid-19 immunisation. Medical history included heart problems, pacemaker. Concomitant medication included heparin. The patient experienced death cause: heart problems on 20Jan2021, blood clot on an unspecified date with outcome of unknown that required hospitalization, tired on 19Jan2021 with outcome of unknown, nauseous on 19Jan2021 with outcome of unknown. The patient was hospitalized for blood clot from 16Jan2021 to 18Jan2021. The patient died on 20Jan2021. An autopsy was not performed. The events were described as follows: The patient was tired and nauseous about 3 hours after her vaccine. She had been in the hospital 16Jan2021 to 18Jan2021 for a blood clot. The patient died at her home on 20Jan2021 between 4 and 7 pm. No treatment required. The vaccine was administered at Hospital Facility. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: death cause: Heart Problems

She went to the living room and fell and couldn't get up; She went to the living room and fell and couldn't get up; tiredness; She has a sore throat and fever blisters on her mouth; lost almost 18 pounds in the last week with all this stuff; severe headache; muscle pain in the back of her neck and back; She has a sore throat and fever blisters on her mouth; violent chills; sick with diarrhea; Dry heaves; This is a spontaneous report from a contactable Consumer. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date not reported) via an unspecified route of administration to left arm on 25Jan2021 at single dose for covid-19 immunization. Medical history included Crohn's disease and Type II Diabetes. The patient experienced sick with diarrhea on Jan2021, dry heaves on Jan2021, she went to the living room and fell and couldn't get up on 27Jan2021, tiredness on Jan2021, she has a sore throat and fever blisters on her mouth on Jan2021, lost almost 18 pounds in the last week with all this stuff on Jan2021, severe headache on Jan2021, muscle pain in the back of her neck and back on Jan2021, violent chills on Jan2021. The patient underwent lab tests and procedures which included weight: lost almost 18 lbs on an unspecified date (lost almost 18 pounds in the last week with all this stuff). She received the first dose of the vaccine a week ago on Monday. For two days she was absolutely normal and fine. The night of the second day she had fallen asleep on the couch and when she woke up it was midnight. She knew immediately she was going to be sick with diarrhea. She had dry heaves. She never vomited. The dry heaves were longer than she has had in her life. The diarrhea kept going and going. She went to the living room and fell and couldn't get up. She is 80 years old (as reported). She has never had that happen before. She slept on the floor until six in the morning. When she woke up she managed to get up. She had so many of these side effects. She has tiredness, severe headache, muscle pain in the back of her neck and back, violent chills. She has never had chills so violent before. She has a sore throat and fever blisters on her mouth. There must be 9 or 10 of them. It is a never ending list. She has lost almost 18 pounds in the last week with all this stuff. The symptoms have not stopped. Outcome of the events was not recovered

headaches/her head hurt; fever; threw up; pain across her shoulder; top of my arm swollen and then it ran straight to my back; suffering pain; arm was real sore /pain in the left arm/her arm felt like it was going to fall off; sick as a dog; She was very upset; nausea; her back still hurts to move/it ran all way over to my back; didn't feel like eating; sneeze; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 26Jan2021 (at the age of 81-year-old) as a single dose for COVID-19 immunisation. The patient medical history and family medical history. prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she was administered with the first dose of the vaccine on 26Jan2021, and she has been feeling sick as a dog since she got it. The patient wanted to know about the ingredients used in the formulation of the Pfizer's COVID-19 vaccine. It was reported that patient had been suffering pain on 26Jan2021. The patient took pain pills for the pain. On 26Jan2021, the patient arm was real sore, her arm felt like it was going to fall off/pain in the left arm and on 27Jan2021, the patient experienced hurting in her head/ headaches. The patient reported that she would not have taken the vaccine if she had known her arm would hurt like that. On 27Jan2021, she started having sharp pain across her shoulders, through her shoulder blade to the middle of the back . She tried a heat pad, ice packs and the pain just keep shooting and she believes she had a fever with it. She threw up. She was very upset with all of this and mentions that her husband had passed away. It was reported that patient took pain medication referring to Robaxin 500mg and it didn't work. She also took Methocarbamol 500mg and it helped a little but not a lot. Adds she called the paramedics. The paramedics examined her and told her they had been to the Navy hospital several times and it was very crowded and they advised her to take Tylenol. She took the Tylenol 325mg and she went to sleep but when she woke up she still had the real sharp pains. She thinks the Tylenol helped some. She also took Ibuprofen via oral route at a dose of 400mg as needed per the instruction of the paramedics at. Mentions her symptoms were improved but her back still hurts to move on an unknown date in 2021. She has not eaten except to take medicine. She didn't feel like eating on an unknown date in 2021. She was scheduled to receive the second dose on 16Feb2021 but wanted to refuse because she heard it is even worse than the first time. The patient reported that she experienced sneeze on an unknown date in 2021. The patient reported ‘top of my arm swollen and then it ran straight to my back and I cannot get no relief on 26Jan2021; I really get sick with pain I mean with pain, it ran all way over to my back (as reported). It was reported that Pain is so bad; I have been in pain; I have been laying, it's hurt me so bad (as reported). The patient also experienced nausea on an unknown date in 2021. The patient was suggested to rest until feel fine. The patient called the ambulance but they (staff) confirmed no need of emergency room and want the patient to rest until she was fine. They told her not to get up and she don't want to get up either. Therapeutic measures were taken for suffering pain, pain across her shoulder, headaches/her head hurt, her back still hurts to move/it ran all way over to my back, top of my arm swollen/her arm was real sore and pain in the lefts arm/her arm felt like it was going to fall off. The patient did not receive any treatment for the events. The events were reported as non-serious by the reporter. The outcome of the events pain, sick as a dog, nausea, her back still hurts to move/it ran all way over to my back, didn't feel like eating, sneeze, she was very upset, arm was real sore /pain in the left arm/her arm felt like it was going to fall off was unknown while for other events was recovering.

About 4 days after receiving vaccine, started to get a headache which lasted for about 1 week. Also felt like I was coming down with something. Felt nauseous at times but had no vomiting. Spent about 2 days in my recliner because of overall feeling of unwell ness.

Systemic: Diarrhea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Admitted to ER on 3/15/21 released on 3/16/21. Experienced extreme vertigo, vomiting, and diarrhea. Still a little weak today (3-18-21).

severe ulcerative colitis flare up; vomiting greater than 7 times; gray skin pallor; slightly jaundiced; This is a spontaneous report from a non-contactable nurse. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 81 years of age), dose 2 intramuscular, administered in arm right on 19Feb2021 17:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hypertension and hyperlipidaemia. The patient's concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, first dose at 81 years of age, intramuscular in the right arm on 28Jan2021 for COVID-19 immunisation. The patient was not pregnant. The patient had not received other vaccines in four weeks. The patient had no COVID prior to vaccination nor was she tested post vaccination. She had no known allergies. The patient experienced a severe ulcerative colitis flare up starting within 24 hours of the 2nd vaccine. Initially, as a exceptionally private and stubborn person, she did not report her progressing symptoms to her family and only after she "felt as if she was actively dying" did she reach out for help (01Mar2021). Additional symptoms included severe burning pain across her lower abdomen, vomiting greater than 7 times, persistent diarrhea, gray skin pallor and she appeared slightly jaundiced. Patient refused repeated offers from daughters to be taken to hospital. On 01Mar2021, contact was made with her gastroenterologist and in the morning of 02Mar2021, she was restarted on her UC treatment, which was oral budesonide (unsure of dose). Outcome was improving. She was now able to intake food and liquids and her UC symptoms are resolving. She was up and active again. The events started on 20Feb2021 with outcome of recovering. Therapeutic measures were taken as a result of the events. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Based on data provided and temporal association, the reported events are assessed as 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.

dizziness / vomiting both occurring now paramedics called. Conference call operator / patient's daughter. Pt rcvd Covid vaccine 2nd dose yesterday. patient having protracted vomiting/dizziness. pt does get medication for dizziness regularly and has history of stress induced vomit. pt not feeling well. Daughter able to provide some of the information regarding vaccine but very nervous and d/c as soon as EMS arrived. Agency had recommended to have EMS evaluated and transport as needed. Adv pt should f/u w/PCP ASAP. Adv to call back if any questions. Adv daughter that she may get call back from PIC/Covid Hotline.

Patient presented and was admitted through the ED for complaint of epigastric abdominal pain onset this morning that has since resolved, as well as complaint of shortness of breath, fatigue that is persistent. She had HD but stopped 10-15 minutes into HD with noted severe bradycardia. Diagnosis on admission - 3rd degree heart block. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine.

light headedness; queasiness; I was functional but I wasn't myself; This is a spontaneous report from a contactable 81-year-old female consumer reported for herself started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via Intramuscular on 29Jan2021 at single dose in arm left for covid-19 immunization. The patient relevant medical history included I have environmental allergies pollen (took an antihistamine), mild asthma and paroxysmal atrial fibrillation. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) for environmental allergies. Past drug included Allegra (before I took the shot and I also gave an Allegra to my husband before he took his shot, and he was fine). On an unknown date, the patient experienced a mild reaction which was light headedness, queasiness and it lasted several hours. She was functional but she wasn't herself. After about several hours the patient began to feel somewhat better. The patient didn't take any treatment for the events. The outcome of the events was recovering.

Day 2 following vaccination-headache, severe diarrhea, vomiting Day 3- mild diarrhea, general feeling of feeling ill, fatigue Day 4- symptoms had nearly resolved

got really tired'; chills; diarrhea; she threw up; had swollen lymph nodes; nausea; pain in her arm; This is a spontaneous report from a Pfizer-sponsored program. A 81-years-old contactable female consumer(patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number, Expiration date: unknown) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. On 28jan2021, patient experienced some reactions like chills, nausea and diarrhea so was asking if she really needs to take the second dose. Follow-up information was received on 12Feb2021 from a contactable consumer reported that patient experienced pain in her arm, got really tired', chills, diarrhea, vomiting, and swollen lymph nodes for a little bit. Caller stated that her husband only experienced a sore arm. Information on the lot/batch number has been requested.

mucous membranes inside her nose were burning; headache; soreness in the arm; inside of cheeks were puffy; random itchiness; increased fatigue; Irritation roof of mouth; tongue was raw, red, and puffy; This is a spontaneous report from a contactable consumer or other non hcp. An 81-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: unknown; Expiration Date: unknown), dose 1 via an unspecified route of administration, in Arm Left on 04Feb2021 13:00 as SINGLE DOSE for COVID-19 immunization. Medical history included restless legs syndrome, multiple allergies, disability (handicapped for 7 years), osteoarthritis, drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took ampicillin and experienced rash, ampicillin and experienced drug hypersensitivity. After 1.5 hours after vaccination, the patient experienced headache, random itchiness, increased fatigue, irritation roof of mouth, tongue was raw, red, and puffy on 04Feb2021, mucous membranes inside her nose were burning, on 05Feb2021. The patient stated some side effects including: the inside of her cheek became puffy, the roof of her mouth became irritated, her tongue became raw and puffy and red, the mucous membranes became irritated, and she had burning inside her nostrils. The roof of her mouth and inside of cheeks is diminished but it is not gone and has been 6 days. The caller stated she has multiple allergies and chemical sensitivities and asked if this is a common side effect in sensitive people. She stated she has not taken any allergy medicine. The caller stated she also had a headache that lasted the rest of the day, soreness in the arm, random itchiness that began an hour and half after and continued to next day then began to disappear, intense fatigue for 3 days, her restless leg was increased through yesterday, for several days she felt out of sorts, didn't feel like herself, she can't put her finger on it but she felt off, she had increased joint and muscle pain a day and a half later, and has heard that whatever side effects you experience they will be more intense after the second dose. The patient stated that the facility didn't give them a vaccine card, NDC/LOT/EXP: Unknown. She says that they gave her some copied pages and a date for her next dose appointment which is 25Feb2021. She says that her first dose was injected in her left arm on 04Feb2021 at 01:00PM. She says that 1.5 hours after her first dose she had a headache and itchiness. She says that the itchiness was random and minor, and went away by the next day with no treatment. She says then she also had increased fatigue that day, which lasted for three days. She says later on Thursday, the day she got the vaccine, the inside of her cheeks were puffy, the roof of her mouth was irritated, and her tongue was raw, red, and puffy. She says she did no treatment for this, though she does have Benadryl in her house, she is so sensitive to Benadryl (UPC/LOT/EXP: Unknown) because she has restless legs syndrome, it makes it worse. Caller says she did not take the Benadryl. Caller says she is handicapped and has difficulty standing with restless legs syndrome. She says that those symptoms diminished, but have not gone, it has been 6 days already which is why she looked at the information from Pfizer. She says that the mucous membranes inside her nose on the following day were like burning, and she couldn't use her regular nasal wash that she uses. No further details provided about nasal wash. She says that was subsiding, and the thing that has been the most aggravating right now are the feelings in her mouth, which are not listed on normal side effects, which is why she called to find out if they could be side effects, and find out if it could be her immune system working. The patient stated she has had previous allergic reactions 7 years ago, when her allergist wanted to immunize her to Ampicillin allergy, which she is allergic to all major antibiotics, and when she had that she had a thick tongue and a puffy roof of her mouth and irritated tongue. She says that her allergist wrote a note saying they felt this was her immune system reacting. She says that the allergist was trying to help her with desensitization for her allergies, and she wanted to know if something like this happens with this COVID-19 vaccine, if a number of sensitive people that are sensitive to medications have reactions like this to it. She says that she thought she would call here before calling her general practitioner. Ampicillin NDC/LOT/EXP: Unknown. She says she is allergic to Ampicillin and Penicillin, she took Ampicillin 30 years ago and had a rash, and is allergic to everything else. She says that she was supposed to have elective surgery, so her doctor wanted to make sure she would be able to take an antibiotic, so her allergist chose Ampicillin. Penicillin NDC/LOT/EXP: Unknown. The patient stated she has not had any other recent vaccinations or started any new medications. She says she has eaten or drank nothing different recently. The patient stated she has so many allergies that she can't tell what they all are, she has multiple allergies and chemical sensitivities that she doesn't know what they are. She says there are inert ingredients in some medications too, she is difficult to prescribe for, as well as some things have multiple fillers but those have never been identified as to what is bothering her, so she just tries different manufacturers to see which don't bother her after she takes them. She says she is an unusual case. The patient says that she is handicapped and has had restless legs syndrome which she has had for a number of years. And handicapped 7 years, and she needs two hip replacements. She says she has end stage osteoarthritis, documented as provided. She says when her allergies and chemical sensitivities become active, with her restless legs syndrome it is difficult to stand, it makes her restless legs syndrome worse. The outcome of the event random itchiness was recovered and the outcome of all other events was unknown. Information on the lot/batch number has been requested.

Patient received her first dose of covid vaccine on 3/17 who comes to the hospital on 3/31 for increased fatigue and decreased appetite which began 3d after vaccine. In ER she tested + for covid and CXR was unremarkable, pt was discharged home. Patient returns to ER for increasing shortness of breath causing her to increase her home 02 to 3L and then ultimately 4L prior to EMS arriving. She notes she is dizzy and fatigued. She denies chest pain, n/v, but did have 1 episode of diarrhea PTA. This morning patient requiring 5L NC 02 and ID asked to evaluate for recommendations. Remdesivir withheld as symptom onsent > 2 weeks ago. Tocilizumab 8 mg/kg and dexamethasone 6 mg daily initiated.

81 years old woman with PMH of Anemia, CAD s/p CABG, Carotid stenions, CHF with EF 30%, COPD, DM, HLD, HTN, who presented to the ED with chief complaint of increase SOB over the last 5-6 days. The SOB got worse with exertion. Pt stated that she was using O2 only at the weekend but now she required O2 all the time. The associated symptoms wheezing, SOB, productive cough with yellow sputum, nausea, chills, fever, and diarrhea. Pt stated that she been having 6 episodes of diarrhea per days. Pt denied having any vomiting, chest pain, abd pain. Pt stated that she tested positive for Covid on 3/23/21. Per chart review, patient had 1st COVID 19 vaccine on 03/04/2021, tested positive for COVID 19 on 03/24/2021.

break in rash/rash in mouth and throat; sore throat; dizzy; weak; felt like sleeping all the time; pain in her arm; blood clot in right leg; couldn't walk; veins are swollen; right knee got swollen; ear ache; felt like burning/ sore in her mouth like she was burned; sore in her mouth like she was burned; nausea; headache; slight fever; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in right arm on 09Mar2021 (Lot Number: EL9266) at single dose for covid-19 immunization. Medical history included arthritis, respiratory issues, allergies, Eczema of the nipples and breast, arthroscopic surgeries, she lost her voice. Caller stated she exercised everyday, she did yoga. Caller reported the last 2 years she hadn't been able to climb the mountain on the stairs. Caller states she didn't catch a cold, she was fine, she was very active. She was good except arthritic conditions, she has had arthroscopic surgeries, that was a side effect of that. Caller reporting she was a first responder and had some respiratory issues. Caller stated she had some allergies, if with dust or smoke, her throat constricts, it was just small, like her throat. She cannot be around that. She got once in a while, when she got in a rush. Caller stated before the vaccine, she had eczema in her nipples, on her breast. Caller stated she never got sick, besides the rash she got once in a while. Caller states but she was very healthy otherwise, no medication, no smoking, no drinking. Caller stated she was from 9/11, this was what happened with her voice once in a while, she lost her voice. Caller stated she had had some respiratory issues and allergies and so on. Caller stated she was here for 56 years and her mother died of old age so she was not sure. There were no concomitant medications. The patient previously took advil. Caller stated she used to take Advil when she went to the gym and had problems but she hasn't taken Advil for a while. She didn't take meds. Caller stated she didn't drink or smoke because what it did was it gave you a release. Caller stated she was not taking none, she was pushing through and hoping it will heal itself. The patient experienced blood clot in right leg on 26Mar2021, break in rash on an unspecified date, headache on 09Mar2021, slight fever on 09Mar2021, veins are swollen on 12Mar2021, right knee got swollen on 12Mar2021, sore throat on an unspecified date, ear ache on 10Mar2021, nausea on 09Mar2021, rash in mouth and throat on an unspecified date, felt like burning/ sore in her mouth like she was burned on 10Mar2021, sore in her mouth like she was burned on 10Mar2021, dizzy on an unspecified date, weak on an unspecified date, felt like sleeping all the time on an unspecified date, couldn't walk on 12Mar2021, pain in her arm on an unspecified date. Was a first responder, sometimes break in rash once in a while. Got Pfizer 1st vaccine 09Mar, was scared to have difficulty breathing however had headache, slight fever, right knee and veins were swollen, sore throat, ear ache, nausea, rash in mouth and throat also felt like burning also was dizzy and weak and felt like sleeping all the time. Caller stated she was told by her doctor to take the shot on 09Mar2021. Caller stated she had headache, slight fever, then her head was ok the fever was gone but the headache persisted as of today. Caller stated she still had headache and ear ache and her knee got swollen, her right knee. Caller stated for a few days she couldn't walk. Caller reported she has arthritic conditions in knees, she exercises everyday and no problem, but she couldn't walk for a few days. Caller states now she is able to walk on something, but the veins in the knee were still there and she didn't know. Caller stated she was due for second next on Tuesday and she was wondering what to do. Caller stated she was honestly worried about this reaction after the first shot. Caller stated she was told the 2nd had a worse reaction, so she was really weary and worried. Caller stated she only slept 5 hours at night, but now she wanted to sleep all the time. Caller stated she had such a headache and earache. Caller stated it made her nauseous, like in a sea or something. She stated she didn't know how to explain. She didn't vomit like when you were nauseous, it wasn't that feeling. Caller stated it was just lingering like when you were in the ocean. Caller reported headache has gotten better. It has gotten worse and then gotten better. Caller stated the earache was so painful and was still there. Caller reported she got it during the day and when she lied down, but the severity had subsided. Caller stated she didn't measure fever. She wanted to say after that, her mouth was sore after fever from the heat or from the vaccination. Caller stated her mouth was still today, still sensitive. Caller reported it was like her throat and her mouth was so sore like a burn. Caller reported her headache was mostly on the left side, but went to the right side too. Caller reported she could feel it in her eye, it hurt and her ear hurt. Caller reported her sore throat, the upper part, was still sensitive. Caller stated she couldn't swallow, but it was clear, her mouth was clear, only the upper top she would say. Caller stated it's 99% gone, its healing. Nauseous, like in a sea, its not like she has it all day long- nauseous- maybe once a day, nothing severely like what she had for a few things. The patient had a pain in her arm and she had that symptom one night and the following day she had nothing. Her arm was cooperative. Since she had been diagnosed with a blood clot. She saw her doctor on Friday and was recommended that she took some medications. She continued to have headache which she reported, though not as bad. She also reported that she had a sore mouth and earache. She was still fighting symptoms and didn't know what to do with the blood clot. She was scared to take the blood thinner Eliquis and that she will have side effects that it will do her harm she felt Eliquis will do her harm if she received the second dose of the vaccine or takes Eliquis. She was supposed to 20mg daily which she felt will kill her given her body was not healed from receiving the first dose of the Covid-19 vaccine. There was no prior vaccinations within 4 weeks. She was prescribed Eliquis Film-coated tablet (Lot Number: ABN4449S, Expiry date: Feb2023) 20mg daily for blood clot but had not started because she felt it will kill her was scared to take the second dose of the vaccine. The patient underwent lab tests and procedures which included Sonogram: blood clot in right on 26Mar2021. Therapeutic measures were taken as a result of blood clot in right leg. There was Physician Office Visit for all events. The outcome of the event blood clot in right leg, veins are swollen, right knee got swollen, couldn't walk was not recovered, of event slight fever was recovered on 10Mar2021, pain in her arm was recovered, of event ear ache, nausea, felt like burning/ sore in her mouth like she was burned, sore in her mouth like she was burned was recovering, of other events was unknown.

3rd or 4th day after shot: Extreme fatigue, severe weakness, shakiness, especially in lower extremities. Often trembly with complete lack of appetite (lost 6 pound in 2 weeks). Only wanted to sit or lie down- unable to go for daily walk (no strength). No fever or respiratory symptoms. This extreme condition lasted for approx. 10 weeks, during which time I saw my doctors five times for diagnosis or assistance. They could find no reason for my sudden symptoms except for adverse reaction to the vaccine, and were unable to assist. I mostly sat and laid around for 10/11 weeks , after which my symptoms improved gradually, and I am feeling better at this time.

Jan 13 first dose received...Jan 30th collapsed at night by herself. Was able to get up and go back to bed. Next day was taken to urgent care and sent by emergency to hospital. Suffered large blood clot in the leg that broke off and traveled to the lungs. Acute saddle pulmonary embolism with acute cor polmonale. Was put on blood thinners and released from hospital on 2/2. As soon as we got home from the hospital she suffered from a massive gastrointestinal intestinal bleed and had to be rushed back to the hospital. Two days later while still in the hospital she suffered a mild heart attack and had a stent inserted.

Entire clothes were drenched. Face was red. Very weak. Her left eye was closed. No appetite. Slept all day. Body was hot to touch. Lasted for 24 hours.

Patient diagnosed with COVID-19 infection on 3/31/21, chest xray at that time unremarkable. Patient presented to outlying hospital on 4/4/21 with worsening cough and nausea. D-dimers were elevated and CT chest showed scattered airspace opacities. Prescriptions for antibiotics and patient discharged from ED. Patient again presented to outlying ED on 4/6/21 with worsening shortness of breath and nausea and poor appetite. Patient was hypoxic saturating 86% on room air and was requiring 3L to maintain oxygen saturation. Repeat chest x-ray showed mild-to-moderate bilateral airspace opacities. Patient was admitted to outlying hospital on 4/6/21. Patient transferred to this hospital on 4/9/21 with severe diffuse bilateral pulmonary infiltrates on CT chest and worsening COVID-19 infection. Patient was treated with oxygen, antibiotics, remdesivir, and steroids. Patient was discharged to home with new home oxygen.

tired; Chills; temperature going up and down many times, the most it went to was 100.5F then went to normal; puking/throwing up; Nauseous; Headache; This is a spontaneous report received from contactable Nurse. A 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262 and expiration date: 31May2021), via an unspecified route of administration at the left arm on 17Feb2021 at single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (Lot: Lot 1283) on 27Jan2021 for COVID-19 immunization. The patient's medical history included immune system disorder. Concomitant medications included promethazine (PHENERGAN) and loratadine (IMMUNIX). It was reported that patient experienced the headache a couple days after second dose. The patient first got tired, then had chills, her temperature was going up and down many times, the most it went to was 100.5F then went to normal. The patient kept taking tylenol for 4 days then after she was nauseous and kept puking. The patient took ondansetron and stopped puking and reported sometimes it works sometimes it doesn't get in system fast enough and then the patient had dry eating and hydrated. The patient feels nauseous and sick still and still has a headache. It was reported that the patient called the doctor wanting a refill on her Phenergan, but the doctor told her no and said that she has to call Pfizer. It was reported that she doesn't understand why the doctor would say that when he knows Pfizer has nothing to do with her receiving her Phenergan. It was stated that he doesn't understand, this is not a new medication for her, she's just getting a refill for something that she's had before. The doctor said that they couldn't do anything. Outcome of puking was reported as recovered and outcome of tired, then had chills, her temperature was going up and down many times, the most it went to was 100.5F then went to normal and nauseous was reported as unknown. Follow-up information has been requested and pending to receive.

Stroke involving paralysis of right arm, right leg, slurred speech, facial droop, nausea, garbled speech

8 days after the 2nd Pfizer shot sudden vomiting including blood and then collapse and died. No other symptoms of sickness leading up to this.

This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on 13Jan2021. Relevant history included mild dementia, high cholesterol. Relevant concomitant drugs included memantine 10MG,donepezil 5MG,atorvastatin, cetirizine hydrochloride (ZYRTEC). The patient was not pregnant. No known allergies. On 30Jan2021, the patient fell and became unconscious after getting up from bed to use bathroom, was able to get up and go back to bed. Next day, 31Jan2021, she told her daughter at 2pm what had happened and daughter took her to urgent care. Urgent care was performed EKG and called ambulance as EKG suggested suspicious activity. She was coughing with blood. Cat scan of the lung revealed acute saddle pulmonary embolism with acute cor pulmonale and a large blood clot in the calf. On 02Feb201 then placed her on blood thinner and discharged her. As soon as arrived home, she began to suffer a massive gastro intestinal bleed and was rushed back to the hospital. On 04Feb2021, she began to have heart issues and suffered a mild heart attack and underwent a procedure to have a stent inserted. She developed the shingles the next day (05Feb2021). The events assessed as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient visited Emergency room/department or urgent care. The outcome of events was resolved with sequel. Treatment therapy involved. The patient was not diagnosed with COVID prior vaccination. The patient had Nasal Swab/Fast Test/PCR (for COVID) in Apr2021 with negative result. Information on the lot/batch number has been requested.

After the first vaccine she experienced pain in arm and pain between the eyes. She also had flu like symptoms for approximately 3 days, and unusual bowel movements not diarrhea, not constipated, but not normal and painful. After second dose had similar reaction bowel issues are still bad and very painful (to the point of vomiting during bowel movements due to pain). She saw her primary care doctor and was Rx'd a cream. This has caused her to decrease her eating. This did not help and she was having loss of visual acuity and started not being able to speak properly so went to the ED for concern over Strokes. had 2 MRIs, and determined not to be having a stroke so was released to home. Sxs seemed to resolve ( like a spell) . Was still having bowel issues and she also developed a rash from the neck to the groin. So she went to a specialist. The Rash cleared after about 3 days. Specialist advised that the sxs were all due to the COVID Vaccine. Flank pain under the right ribs has also been present, this is not improving, it is a dull pain that seems to be worsening ( the bowel seems to be about back to normal now) She is planning on speaking with her PCP about the right flank pain.

This 81 year old received the Covid shot on 2/2/21 and went to the ED on 3/2/21 with the following diagnoses listed below. U07.1 - COVID-19 DIARRHEA FEVER

Profuse Vomiting; chills; dryness; This is a spontaneous report from a contactable Nurse. A 81-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot Number: Unknown; Expiry Date: Unknown) dose 1 intramuscular, administered in Arm Left on 06Feb2021 16:00 as SINGLE DOSE for COVID19 immunization. Medical history included If covid prior vaccination: Yes. Concomitant medications included apixaban (ELIQUIS); propranolol; chlorthalidone; pravastatin sodium for an unspecified indication. The patient did not receive any other vaccines within 4 weeks. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested positive post vaccination. The patient experienced on 06Feb2021 16:00 profuse vomiting, chills, dryness. The patient did not receive any treatment for adverse event. The outcome of the events were unknown.

ears went dead with no sound to be heard, went to walk felt like could not control body, was swaying all over the place, and really sick. sick to stomach when stroke started happening, weaknesses everywhere could not stand up or get up in bed. Started throwing bike up really bad , dizziness happening, spilled out both ends of body, speech little slurred, stroke was happening. Got to hospital still felt dizzy for at least 3 days, throwing up lasted several hours. Zoned out in hospital for awhile but not while stroke was happening, in intensive care for 2 full days, in hospital for 3 days then transferred to rehab in hospital. Left side was affected both arm and leg and slurry speech. Little weakness in right arm. Home from rehab 2 weeks later. Still having issues with leg.

ED to Hosp-Admission Discharged 4/6/2021 - 4/9/2021 (3 days) Last attending ? Treatment team Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) Principal problem Discharge Summary Internal Medicine Discharge Summary Hospitalist Medicine Admission Date: 4/6/2021 Length of Stay: 3 Days Discharge Date: 4/9/2021 Admission Diagnosis Hospital Problems POA * (Principal) Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) Yes Type 2 diabetes mellitus (CMS/HCC) Yes Obesity Yes Hypothyroidism Yes Chronic combined systolic and diastolic heart failure (CMS/HCC) Yes Benign essential hypertension Yes 81-year-old female presented to the hospital with a complaint of fever and cough COVID-19 - now saturating well on room air and Afebrile Complaining of sore throat and difficulty in swallowing- now resolving Back pain improving Episode of diaphoresis and blurry vision -now resolved Home Or Self Care CODE STATUS: DNR (Do Not Resuscitate) Active Issues Requiring Follow-up Follow-up with PCP for further care as outpatient. Test Results Pending at Discharge Pending Labs Order Current Status Blood culture- 2 SETS Preliminary result Blood culture- 2 SETS Preliminary result Hospital Course HPI: See H&P Hospital Course: Patient presented to the hospital with a complaint of fever and cough. She was admitted for COVID-19 with respiratory failure. Since she was saturating below 94%, she was started on remdesivir on admission. Oxygen was given for supportive care. She received albuterol inhaler, Mucinex, Tessalon Perles and Decadron. In addition she complained of some sore throat and received Chloraseptic spray along with lozenges. She had an episode of diaphoresis and change in vision during the hospitalization. There were no events on the monitor and the CT of the head was negative. The symptoms resolved. She also complained of insomnia back pain for which he received melatonin and Lidoderm patch respectively. She is feeling much better and has been saturating well on room air above 95% for the past 2 days. I will continue with the albuterol inhaler, Decadron and Mucinex as outpatient for few more days. She is asked to follow-up with her PCP for further care as outpatient. ED to Hosp-Admission Discharged 4/13/2021 - 4/16/2021 (3 days) Last attending ? Treatment team Weakness Principal problem Discharge Summary (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Admission Date: 4/13/2021 Length of Stay: 1 Days Discharge Date: 4/16/2021 Admission Diagnosis Hospital Problems POA Type 2 diabetes mellitus (CMS/HCC) Yes Hypothyroidism Yes Hyperlipidemia due to type 2 diabetes mellitus (CMS/HCC) Yes Gastroesophageal reflux disease Yes Problem List Resolved POA Resolved Problems Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) 4/17/2021 Yes * (Principal) Weakness 4/17/2021 Yes Generalized weakness 4/17/2021 Yes Home Under Care Of Organized Home Health Service CODE STATUS: Prior Active Issues Requiring Follow-up Test Results Pending at Discharge Hospital Course HPI: See H&P admit report. Hospital Course: Patient was admitted secondary to weakness and hypoxia she recently did have a bout of COVID-19 and had been discharged home and has been set up for remote outpatient monitoring as per protocol. She returns for ongoing weakness. Patient was continued on Decadron and was seen by physical therapy and Occupational Therapy. The patient slowly continued to improve and was now back to baseline functioning. She may be discharged home and follow-up with PCP as advised as she is no longer on oxygen. She is to complete the dexamethasone dose as she had previously been taking to complete a course. Home health had been previously set up at her previous admission.

Office Visit 5/4/2021 screening laboratory testing for COVID-19 virus +1 more Dx Cough ? Diarrhea ? Fatigue Reason for Visit ED to Hosp-Admission Discharged 5/5/2021 - 5/17/2021 (12 days) Last attending Treatment team Pneumonia due to COVID-19 virus Principal problem Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Yes Asthma without status asthmaticus Yes Systemic lupus erythematosus (CMS/HCC) Yes Overview Signed 12/1/2020 7:46 AM Note: Document: 08/22/19 - Consults Rheumatology Paroxysmal atrial fibrillation (CMS/HCC) Yes Atrial fibrillation with RVR (CMS/HCC) Yes Esophageal stricture Yes Hospital Course HPI: patient is an 81 y.o. female with pmh of COPD and HTN presented to the ER with complaint of palpitations. She reports since her second covid short on 4/29, she's been feeling "ill." she states she's been having diarrhea, chills, fatigue, and cough. In the ER, she was found to be in afib with RVR. She was given a one time dose of cardizem but then spontaneously converted to NSR. She is not hypoxic but admits to increased cough and occasional dyspnea. CTA was done in the ER due to elevated D dimer. Pulm embolism was ruled out, however, she was found to have bilateral infiltrates concerning for viral pna Hospital Course: Please send details from consultation note from hematology gastroenterology 81-year-old Caucasian female she had a history of COPD hypertension she was admitted through the emergency room on May 6 with a chief complaint of palpitation chest discomfort. She was found to have A. fib with RVR with underlying history of paroxysmal atrial fibrillation. Patient was admitted and atrial fibrillation is rate controlled in maintain with increase his Lopressor. ACS is ruled out by cardiac enzyme patient was found to have a COVID-19 pneumonia fortunately patient oxygen saturation remained good continue having mild cough. And initially she was not started any dexamethasone or any antiviral remdesivir. But over the time patient actually having mild wheezing shortness of breath but oxygen saturation remained stable so then dexamethasone was started. Heart rate was pretty controlled with current medication Lopressor anticoagulation did not start since patient was found to have a severe thrombocytopenia. Patient was seen by hematologist recommend to bone marrow biopsy thought that the sudden drop possible from infectious source. So then that point Heparin Olympic Eliquis was not started. Over the time patient platelet count back to normal platelet count 1 75,000 Eliquis started 2 days ago. Since she looked tolerating Eliquis heart rate is well controlled after adding dexamethasone she is underlying history of COPD her wheezing is much improved and she is currently on DuoNeb. In the history of asthma without status asthmaticus patient will be discharged home with continue current medication Decadron for 5 more days started Eliquis 5 mg 2 times daily since she is tolerating and platelet count is normal I recommend to check CBC for platelet count in 5 days. This patient will benefit to see hematologist outpatient although she refused to do a bone marrow biopsy. She is having chronic low back pain and currently on narcotics recommend to follow-up with PCP to change his narcotic medication.. Initially she had a CTA chest done which was normal although D-dimer was mildly elevated negative for pulmonary embolism and a mild infiltration concerning viral pneumonia so bacterial antibiotic was not started. Stable to be discharged home she was having intermittent low-grade fever for almost like 5 to 10 days. The fever is totally gone now. She is clinically stable new medication is adjusting increase Lopressor 50 mg 2 times daily. Eliquis 5 mg p.o. twice daily and she is going to go home with Decadron only for 5 days.. Patient also have underlying history of chronic dysphagia patient was seen by gastroenterology recommend to follow-up outpatient in 2 to 3 weeks Follow-up PCP in 5 days, follow-up with hematology as scheduled

Cough Pt states been sick for 1-2 wks, can't eat, no taste, fatigue, diarrhea, slight headaches, cough. Had 2nd covid shot 4/29/21. ? Diarrhea ? Fatigue Patient is a 81 y.o. female HPI Pt presents with concerns of possible Covid 19. Pt reports the following symptoms that started 10 days ago. Sinus pain and pressure No Fever/ chills Yes Headache Yes Body aches No Cough Yes Sob No Sore throat No Nausea/ vomiting/ diarrhea. Yes Loss of taste or smell Yes Medications used:Yes Tolerating fluids:Yes Tolerating. solids:Yes Smoke exposure:No Exposed to someone who tested positive for COVID 19: Yes History of asthma, bronchitis, pneumonia. yes Patient felt sick before receiving her second COVID 19 vaccine on 4/29. She states her and her husband were also exposed to someone at church who tested positive x 5 days ago and they were not wearing masks. She does use her rescue inhaler as needed for her cough. ED to Hosp-Admission Discharged 5/5/2021 - 5/17/2021 (12 days) Hospital MD Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Patient: Date: 5/17/2021 DOB: Admission Date: 5/5/2021 PCP: DO Length of Stay: 10 Days Discharging provider: MD Discharge Date: 5/17/2021 Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Yes Asthma without status asthmaticus Yes Systemic lupus erythematosus (CMS/HCC) Yes Overview Signed 12/1/2020 7:46 AM by LPN Note: Document: 08/22/19 - Consults Rheumatology - Paroxysmal atrial fibrillation Yes Atrial fibrillation with RVR Yes Esophageal stricture Yes

nauseous; terrible abdominal cramps; indigestion; This is a spontaneous report from a contactable consumer or other non hcp. An 81-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunization administered in Hospital. Medical history included hypersensitivity, compromised immune status, respiratory disorder. There were no concomitant medications. The patient reported, she got the 1st dose of the vaccine yesterday and woke up today with terrible intestinal cramps, indigestion on 29Jan2021 15:30 and is nauseous on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of event for nauseous was unknown and for the other events it was not recovered. Follow-up attempts are completed. No further information is expected

Patient brought to the ED with generalized weakness worsening over prior 2-3 days, states she started experiencing after receiving 2nd dose of Covid vaccine. Found to have a positive troponin, hyponatremia. Stress test revealed reversible myocardial ischemia of the inferior and lateral walls of left ventricle with a large defect size but mild defect severity. Patient underwent PCI with DES placement and was placed on triple therapy with aspirin, clopidogrel and eliquis. Patient presented to ED again on 5/23/21 outcome: patient is brought to ED after a fall and loss of unconsciousness, hit her head with large laceration at back of head, 2 episodes of vomiting, leading to terminal events: brainstem compression and rapid deterioration and CS of 2T preclude meaningful survival

My teeth were sore/teeth were so sore she felt like she had abscessed teeth on lower jaw: Medically significant; Inflamed gums; Abscessed teeth on her lower jaw; some kind of side reaction; My gums and the roof of my mouth (Incomplete sentence)/my gums were so raw, I couldn't brush my teeth; My mouth became all inflamed; I have a very hard time hearing you; Equilibrium affected; But I am still deaf in my right ear; This is a spontaneous report from a contactable Nurse (patient). An 81-year-old female nurse received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0169; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in arm left on 12May2021 20:00 (at the age of 81-year-old) at a 2nd dose, single for COVID-19 immunization. Medical history included macular degeneration (diagnosed about 3-5 years ago), low thyroid hormone (seems like she's had forever), high cholesterol just beyond normal (has had for years), banana, avocado, and kiwi allergy (stated all are interrelated because they are cousins to the rubber tree plant. Also, healthcare personnel allergic to latex can and may develop a cross allergy to psyllium which is metamucil); psyllium allergy (patient had an anaphylactic reaction to a metapower bar in 2015. About 7 minutes after eating the bar, she went into a severe reaction and ended up in the emergency room and stayed overnight), flu (every flu shot she received, she has gotten the flu and only takes periodically. She had to take in 2016 and 2015. It had been 5-10 years before that, and another 5-10 years before that), latex allergy (since the 1980's), shingles (having shingles vaccination in 2014 and had shingles 2-3 weeks later, can't remember details. Stated it was a mild case. Patient gets the shingles vaccine and gets the shingles, gets the flu vaccine and gets the flu), atrial tachycardia from 2015 to an unknown date, anaphylactic reaction to a metapower bar from 2015 to an unknown date (about 7 minutes after eating the bar, she went into a severe reaction). Concomitant medications included levothyroxine tablet at a dose of 50 ug, 1x/day, vitamin B complex and akurit (not clarified hence not captured in tab). The patient previously took first dose of BNT162B2 (Batch/Lot Number: TR2613; Expiration Date: 31Jul2021), administered in arm left on 21Apr2021 09:00 for COVID-19 immunization and experienced deaf in my right ear, I woke up with pressure in both of my ears, I could not hear and arm soreness. The patient drug history included synthroid from an unknown date to ongoing (started about 15 years ago) for low thyroid hormone, simvastatin from an unknown date to ongoing (started about a year ago) for cholesterol is slightly elevated, ocuvite preservision from an unknown date to ongoing (taking about 3 years. Macular degeneration has not changed or gotten worse in 3 years) for macular degeneration age related, vitamin D3 (taking for 3 years) for bone health from an unspecified date to ongoing, calcium with magnesium (it has calcium citrate. Been taking a long time. 5-10 years) to prevent osteoporosis, glucosamine chondroitin (taking since late 1990s. About 20 years) for joint health from an unspecified date to ongoing, vitamin C (about 3 years ago. started with the Ocuvite. Eye doctor though it was a good idea to take together), multivitamin (taking since 1995 or 1996. about 25 years) for general health; metoprolol ER for atrial tachycardia from Jan2016 to an unspecified date, baby aspirin from Jan2016 to ongoing (81 mg daily, cardiologist thought it would be a good idea). The patient reported, she received first Pfizer vaccine on 21Apr2021 and equilibrium affected and on 28Apr2021 she could not hear in her right ear and the day before on 27Apr2021 it was like she woke up with pressure in both of her ears. It sounded like heck like she was in the airplane and by yawning she could not relieve the pressure and went to the doctor and was under treatment with steroids and antivirals and she was still deaf in her right ear. She got second vaccine on 12May2021 and on 16May2021 and 17May2021 her gums and the roof of my mouth became all inflamed and her teeth were so sore she felt like she had an abscessed tooth. My gums were so raw, couldn't brush my teeth. So she gargle with some peroxide and some saline and then her teeth were sore like you have an abscess teeth on lower jaw. And then that went away within two days. Pressure in both ears has subsided, but then confirms it is a lasting effect comes and goes a little bit from 27Apr2021 to ongoing. First the doctor put her on valacyclovir and methylprednisone 4 mg tablet by mouth started dose at every 4 or 5 hours, dose was a decreasing frequency of dose over 7 days. Started 05May2021 for 7 days. And then last week he started me on the dexamethasone injections through tympanic membrane into her middle ear last Thursday, 20May2021. Is scheduled to receive a dose today, will skip next week, and then one the following week, and then one the following week after that, states it is a series of four doses and then if that doesn't help, she will have an MRI. States cortisone decreases irritation and inflammation. Adds she is pretty healthy and moves about, gardens takes care of business, goes to exercise class twice a week now partially participates because she gets dizzy from moving her head. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events I am still deaf in my right ear, I have a very hard time hearing you was not recovered; equilibrium affected, some kind of side reaction was unknown; my teeth were sore/teeth were so sore she felt like she had abscessed teeth on lower jaw, inflamed gums, abscessed teeth on her lower jaw, my gums and the roof of my mouth (incomplete sentence)/my gums were so raw, I couldn't brush my teeth, my mouth became all inflamed was recovered on an unspecified date in 2021. Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, unilateral deafness, non infective gingivitis, tooth abcess, toothache, balance disorder cannot be completely ruled out. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethic committees, and Investigators, as appropriate

slept all day, very tired; mouth and throat was dry; mouth and throat was dry; problems with stomach, like hurting; stomach felt warm; could taste shot; Felt terrible; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in right arm on 06Mar2021 at 09:15 (Batch/Lot Number: EN6200) at the age of 81-year-old as second dose single for COVID-19 immunisation. Medical history included ongoing restless legs syndrome, sinus and nose run. She takes a blood pressure medicine and she has restless leg syndrome that she takes a medicine for. She had a regular check up in Dec2020. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EL9269), via an unspecified route of administration, on 13Feb2021 at the age of 81-year-old, as first dose single, for COVID-19 immunization and the patient experienced no adverse events. On 06Mar2021 at 17:30 the patient experienced problems with stomach, like hurting, stomach felt warm, could taste shot and on 07Mar2021 experienced slept all day, very tired, mouth and throat was dry. The patient reported when they gave her the shot she tasted it and then about 17:30 on 06Mar2021 she started having problems with her stomach. Her stomach started hurting. Then it felt like when you put your hand on your stomach like putting your hand on your head for a fever that it felt warm. She felt terrible. On 07Mar2021 she slept all day and she didn't feel like going to work on 08Mar2021 and she's not one that misses work. She only weighs less than 85 pounds, she did not know if her weight had something to do with that. Her husband took the COVID-19 vaccine and he didn't have any side effects. She told her doctor that she wasn't going to get the COVID-19 vaccine until he did. And he got it. It's not like her to sleep all day. She reported her mouth was dry as it could be, like she had cotton in her mouth. She's never sick, she doesn't miss days at work. Is there anything she can take? Her daughter had said people do get sick and it lasts about 24 hours and then they feel better. She took aspirin clarified as Dollar General Pain Relief 500mg, she took 3 at one time. She takes Dollar General Pain Relief when she has a bad headache. She doesn't usually have headaches. She reports the Dollar General Pain Relief did help. Expired 2019 she didn't even see that, that's how much she doesn't use them. She sees AO561 on bottle. She usually does and goes and goes, she's usually doing something. She woke up on 07Mar2021 and her mouth was dry, she has sinus, but her nose usually runs. Clarified nose did has not run since getting the COVID-19 vaccine. Her stomach was better on 08Mar2021 but her throat was still dry. At least her stomach was not hurting. She felt better last night (07Mar2021). She's feeling better and decided take one more day off to not overdo it. She reported that her stomach felt real warm like her stomach had a fever but she did not have a fever and her stomach is fine now. The events did not require emergency room visit or physician office visit. Outcome of mouth and throat was dry was not recovered, outcome of problems with stomach, like hurting and stomach felt warm was recovered in Mar2021, felt terrible was recovering, while outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.

Feeling unwell; Nausea; stomach upset; sinuses are bad; tiredness; muscle pain; Dizziness; possible ear infection; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EN6208, Expiration date: Jun2021), via an unspecified route on an 10Mar2021 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EL9266, Expiration date: 31May2021) via an unspecified route on an 17Feb2021, both as a single dose for covid-19 immunization. Medical history included thyroid and blood pressure. Concomitant medication included lisinopril taking for about 4-5 years and levothyroxine taking may be for 15 years for thyroid. On an unknown date after receiving the first dose, patient experienced stomach upset, nausea, sinuses, tiredness, muscle pain and dizziness. She feels so unwell that she went to the emergency room after the first Pfizer Covid vaccine administered on 17Feb2021 for feeling so unwell. They could not find anything wrong, hence not admitted her. She had improved some but was not really good when she went for the second dose on 10Mar2021. Therapeutic measures taken as a result of the events included antibiotics after the first dose for sinuses and possible ear infection and treated with amoxicillin Clav 875/125mg tablet, dosage two times a day for 21 days, came in an orange colour. The clinical outcome of the events was still experiencing the same side effects after the second dose. No follow-up attempts are needed. No further information is expected.

I was very sick and had abdominal pain on the right with vomiting one month after the second dose of the vaccine. I went to Urgent care and I was sent home. It was bad pain and it reoccurred. I have had the Shingles vaccine and I had the Shingles, and I was given medication because I had the Shingles. It was an Anti-viral which I took for ten days. Two weeks later I had a temperature of 103 and abdominal pain. I was admitted on 05/24/2021 and I had my Gall Bladder removed and the Gallstones removed the next day. I have had Gallstones for years, but I have not had problems.

Painful ribs ,profound fatigue,- frontal headaches, muscle pain, chills , loss of apatite .joint pain , nausea .

blood pressure went up very high, It went up to about 180, 190 even 200 over 80; Anxiety; Headache; slightly nauseous; This is a spontaneous report from a contactable consumer reported for herself. An 81-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot Number: EL9264; expiration date: unknown), via an unspecified route of administration in left arm on 05Feb2021 (at the age of 81-Year-old) as single dose for Covid-19 immunization. The patient medical history included cholesterol and taking medication for cholesterol. The patient stated, she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266; formulation: solution for injection; expiration date: unknown) via unspecified route of administration on 26Feb2021 as single dose for Covid-19 immunization. The patient stated this was the story. She received her two doses of the Pfizer vaccine and the last one received was two and half week ago. Now it's two and half week later and found that number one, after the first dose about 8 days later (unknown date in Feb2021), her blood pressure went up very high. Its normally never get that high. It went up to about 180, 190 even 200 over 80 and then she saw her physician. So, the physician put her on some blood pressure medication, and she got better and then had second vaccine. After that the same thing happen about a week later. Her blood pressure went very high, and she suffered because of it with a lot of anxiety. She wanted to know something about that the blood pressure goes really very high. It was still not regular; it was very irregular. Also, the other thing she wanted to talk about was that when she received the first dose, she had a headache and was slightly nauseous on unknown date in 2021. When she went for the second dose, she did not even look when she was putting a needle in her arm so, felt that the needle went in but shortly after heard her say oh jeez and she know she put it right in her arm, she thought might be she was bleeding, she did not have a look, ended up with a bandage over it and that was it, other day she see it did not have any blood on it. So, one of her friend told her that he had a similar thing happen to him where he felt that some of the vaccine was running down his arm (Further clarification was unknown, hence split was not made) and she was wondering if she got the full dose of the second vaccine, she had absolutely no side effects immediately after over the next day. Also, she took yesterday a test for antibody and that came out negative. The caller wanted to know that if she had antibody now with the two doses. Also asked does the blood pressure go up very high after the two doses. The patient underwent lab tests included antibody test with results shows no antibodies on unknown date, blood pressure (It went up to about 180, 190 even 200 over 80) on unknown date in Feb2021. On an unknown date, the blood pressure was between a 140-150. The patient received treatment included Losartan 75 mg. The adverse events resulted in physician office visit. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289470 same patient/drug, different dose/event

Chills; Tiredness; Pain stomach; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN9581) via an unspecified route of administration, in right arm on 02Feb2021 11:30 (at the age of 81-years-old) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration on 12Jan2021 at 9:30am as 1st dose, single for covid-19 immunisation. No additional vaccines administered on same date of the pfizer suspect. Patient explained that it had been a week since getting her second shot and she went through the chills (on 03Feb2021) and muscle aches, but the acute tiredness is still on going. Caller clarified that there were no muscle aches. She explained she did have pains in the stomach (on 02Feb2021). This started 6 hours after the second dose and lasted about 8 hours. Acute tiredness this started Wednesday (on 03Feb2021) and had gotten worse. It is now a little better but still ongoing and exhausted. Adverse event did not require a visit to emergency room or physician office. Outcome of the event fatigue was recovering, pain stomach recovered on 03Feb2021 and chills recovered on 04Feb2021. Follow-up attempts completed. No further information expected.

Blood clots in Lungs discovered June 29, 2021 after being admitted to hospital June 28th. In the weeks leading up to diagnoses patient was feeling extreme lethargy, nauseous, lack of appetite and general extreme discomfort.

82 y/o female, PMHx of CA, DM, HTN, hyperlipidemia, IBS, osteoporosis, RLS, seizure disorder, bladder prolapse, and diverticulitis admitted for altered mental status, elevated blood pressure, nausea and shaking, on 6/22/21. Pt tested positive for Covid, but did not exhibit symptoms except may fever. Pt has chronic ulcers on bilateral toe with purulent drainage, undergoing wound care. Toe ulcers found to be source of infection. Was put on clindamycin, Flagyl, and vancomycin (but developed allergic reaction to vancomycin). Pt was discharged to home on 6/23/21.

Patient vomited one time, 1 hour after administration, observed by nursing staff, Patient had no other complaints or signs prior to vomiting, patient monitored for additional 15 minutes, and did not develop any other symptoms.

first dose on 21Dec2020/ second dose on 04Jan2021; first dose on 21Dec2020/ second dose on 04Jan2021; her fever went up to 101.4/ her fever is down to 99.6; still does not feel good/ felt sick/ felt terrible; wanted throw up; shaking chills; extreme weakness; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via unspecified route of administration on 21Dec2020 at single dose, and second dose (lot number: EL3246), via unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient stated that she got it in the evening and had a fever and felt sick like she wanted throw up. She stated that her fever went up to 101.4, that she felt terrible, had shaking chills and extreme weakness. She tried to drink a lot of liquids thinking that would help. Stated that it was a really bad experience. She clarified that all of these side effects were with the second dose. She had no side effects with the first dose. She reported all of this previously. She stated that she called in fever down 99.6 and did not feel good. She stated that the Tylenol brought fever down a little bit. She was still not able to go to work. The outcome of the event "her fever went up to 101.4/ her fever is down to 99.6" was recovering, the event "still does not feel good/ felt sick/ felt terrible" was not recovered, while other events were unknown.

Patient awoke at approximately 1:50 AM experiencing sever chilling with rigors. Vomited once . Took temperature, wrapped in blanket and took two Tylonol tabs with water. Episode lasted approximately 40 minutes. Has experienced no further episodes and temperature has remained normal.

vomitting, diarrhea, hypotension, bradycardia 2 hours after the vaccine was given treatment: placing the patient in trendelenburg position until BP improved after 1 hr

This is an 82-year-old female with history of cerebellar degeneration, who had her first COVID vaccine today around 11 a.m. she was in her usual state of health prior to that time. About two and half hours afterwards she became nauseated. She had several bouts of emesis and then had a fall. She was found to be hypotensive and bradycardic. The ambulance crew actually gave her atropine at the same because she had a pulse in the 30s, improved her quickly and she presented to the ER. She is to remain very orthostatic, received several liters of IV fluid as now symptomatically better. She remains a little nauseated. She denies any headache, diarrhea, fatigue, or myalgias. She does not feel quite right. She is still dizzy with sitting up.

pt stated the night after the covid vax she had chills, headache, nausea, fever, weakness. Pt stated in bed next day since she was unsteady on her feet and had 101 fever. Pt called PCP to let them know and will FU with regular scheduled appt.

Resident received the 2nd dose of Covid-19 Vaccine on 01/29/2020, reported feeling Nausea on 01/30/2021 and had 2 falls, second fall resident became lost consciousness while ambulating and abruptly feel to the ground . Paramedics were called and transported her to ER evaluation.

Slight ache at injection site....lasted about 2 days Woke up Friday am...approx. 15 hrs. after injection...with large swollen area in throat under right side of chin...presumably a lymph gland, which is sore to the touch and uncomfortable when swallowing. Has not gone away yet. Seeing my Doctor tomorrow.

Vaccine shot #1 was received in shoulder on Monday 1/25 around mid-day. At mid-day the day after (1/26), patient began to feel nauseated. By 9pm she was vomiting, but dry heaves because she had not eaten all day. Vomiting resolved a bit after midnight. Some residual nausea until noon 1/27.

got the 2nd vaccine on Thursday and already had symptoms from 1st vaccine but became weaker, vomiting, diarrhea. headache went to the ER Sunday . She was coherent just weak. Did Xray of stomach found out she had colitis , started her on antibiotics and admitted her and by the next morning She started having delusions, almost like having a seizure. on blood work her magnesium was low. She started retaining fluid. Thought maybe she had stroke but CT showed nothing. Now she doesn't know who she is and just repeating numbers. Pt is currently in the ICU. She has a feeding tube now do to not eating.

Diarrhea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), via an unspecified route of administration in left arm, on 05Jan2021 at 13:30, at a single dose, for COVID-19 immunization. The patient's medical history included diabetes, arthritis, vitamin D, bones, gums, eye, joint pain lubrication, hair and nail growth and strength, control sugar, atrial fibrillation (Afib), heart, supplement, cholesterol, liver clean, and gastro problem. The patient's concomitant medications included apixaban (ELIQUIS) for Afib from 2019 (a year and three-fourths), metoprolol for heart from 2019 (a year and three-fourths), metformin hydrochloride (METFORMIN ER) for diabetes, berberine to control sugar, biotin from 2011 (for 10 years) for hair and nail growth and strength, Silybum marianum (MILK THISTLE) to make liver clean (two or three years), hyaluronic acid for joint pain lubrication, niacinamide for diabetes, chondroitin sulfate/ glucosamine sulfate (GLUCOSAMINE CHONDROITIN) for bones, Monascus purpureus (RED YEAST RICE) for cholesterol, colecalciferol (VITAMIN D3; UPC Number: 3373900373, Lot Number: 3162111, and Expiration Date: Jun2024) for vitamin D, probiotics for gastro problem, betacarotene for eye, ubidecarenone (COENZYME Q10) for gums, calcium/ magnesium (CALCIUM MAGNESIUM) for bones, and unspecified multivitamins as supplement and OSTEOPHASE for arthritis; all were ongoing. The patient her first dose of COVID-19 vaccine dose on 05Jan2021. The patient had experienced diarrhea ever since 09Jan2021 and is still continuing until today. The patient experienced a sudden onset of diarrhea and it has continued on and off since then; it is persisting or worse. She has seen a gastroenterologist, but they don't have any answers, sent stool cultures in Jan2021 but no results yet. The patient was asking if this is a documented adverse event. The patient is scheduled on 26Jan2021 for the second dose. With this experience, the patient was asking what to do with the second dose- if she should get the second shot. The patient had not recovered from the event.

blue finger tips--red spots on upper legs that turned black the next day--100 degree fever-nausea-headache--upper legs swelled up and was discolored for a few days

Severe headache, nausea and vomiting lasting two days. Rx. Small sips of Gator Aid, Recovered after two days.

Nauseous; nervous; This is a spontaneous report from a contactable consumer(patient). An 82-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunization, fish oil, lactobacillus casei (RESTORA RX), via an unspecified route of administration from 21Jan2021 08:30 to an unspecified date at unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient was calling in regards to the Covid Vaccine. She had the shot(covid vaccine) on 20Jan2021 at about 10 or 10:15AM. After her First dose, She had a doctor appointment at 11:20, 20Jan2021, the doctor put her on a new medicine, the Restora RX was in capsule form, she started that on 21Jan2021 at 8:30AM. She was nervous. She was nauseous on 21Jan2021 at about 8:30AM. She was a little nauseous and was basically trying to find out which one was causing it, the vaccine or the new medication. The name of the new medication was "Restora Rx". The action taken in response to the event for fish oil, lactobacillus casei was unknown. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Redness and heat on R foot, left after 15 minutes. Upset bowel system. Have always had opposite problem.

Pt admitted with ICH, likely secondary to increased ICP from nausea and vomiting after receiving her second pfizer covid vaccine.

12 hours after receiving vaccine I woke with severe stabbing pain in stomach, moving up left side went to ER about 48 hours later, diagnosed Shingles, slight rash on left side above breast around to left back shoulder I continue to have shingles

Started feeling achy around 11:00 PM. Took Tylenol. Was achy all day Wednesday and took Tylenol every 4-6 hours. Woke up Thursday morning and couldn't get out of bed. I was dizzy and nauseous. I got up 3 times to use the bathroom and couldn't even swallow water until 9:30 PM. I had 1/2 cup soup and water that evening. Thursday I was only slightly dizzy but was able to eat and drink. I didn't feel well enough to leave my house until Sunday. Today is a week since the second dose and I'm almost back to normal, but still tired. FYI, I did have COVID last March. I was quite sick but not hospitalized. I received phone calls every other day from the DOH during the almost 3 weeks I was in isolation at home. I gave plasma 3 times after recovering.

Client verbalized feeling nauseous and weak. Client was evaluated by rescue and released to go home at 10 am.

Fri 2/5/21 , 6 am teeth chattering, weak, nausea, tiredness, slight headache, light headed, extreme diarrhea (may be due to antibiotic) very slight soreness as injection cite. This lasted for 48+ hours. Did not feel myself for 72 hours.

Pfizer-BioNTech COVID-19 Vaccine EUA The first symptoms to appear at approximately 8:00 pm on Feb. 9th the day of my mom?s vaccine were headache and diarrhea. The following day, 2/10 she seemed to feel better and went on with her day. The night of 2/10 she awoke coughing and wheezing. She called 911 at approximately 4:45 am on 2/11. They transported her to hospital.

Diarrhea next day, Sunday night around 7 pm. Bleeding on her pad like menstration. All better next day, except minor pain on lower stomach.

Had major vertigo on my first shot. Saturday i felt the feeling like i was off the floor again . not so much vertigo but like i was floating. yesterday i ate lunch and very quickly after i got diarrhea very suddenly and i felt i emptied my entre body This morning i have had pain in my stomach but seems to be subsiding as the day goes on.

sometimes the pain in her neck affects her ear and swallowing; sometimes the pain in her neck affects her ear and swallowing; it was shooting pain up into her skull and the top of her head; neck pain on the left side; her skin on the left side of her neck is sore to touch; This is a spontaneous report from a contactable nurse (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269, expiration date was not reported) (at 82 years of age), via an unspecified route of administration in the left arm on 06Feb2021 15:40 at a single dose for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension. There were no concomitant medications. The patient did not take any other vaccinations within four weeks prior to the first administration date of the vaccine. She had no adverse events prior vaccinations and no illness at time of vaccination. The patient received her 1st dose on Saturday (06Feb2021). On Sunday (07Feb2021), she had neck pain on the left side, which was the same as she got the vaccine, and it was shooting pain up into her skull and the top of her head. She stated that her skin on the left side of her neck was sore to touch on 07Feb2021. Sometimes it affects her ear and swallowing on 09Feb2021. She stated that he looked in her throat and it looked okay. She wanted to know if this was from the vaccine. She stated that the shooting pain was killing her today. She had been using Bengay, heat, and Tylenol which lasts about 8hrs. States that the pain woke her up last night, so she took 2 Tylenol Arthritis. Her 2nd dose of the vaccine is scheduled for 27Feb2021. Her husband kept saying it was from the shot, but she doesn't know. She asked if it was then what is she going to do with the 2nd one? The patient did not go to the emergency room nor visit a physician's office for the events. The outcome of the event neck pain was not recovered while recovering for other events. The events neck pain on the left side, skin on the left side of her neck is sore to touch, and sometimes the pain in her neck affects her ear and swallowing are reported as medically significant events.

Fever 101+ for two days, severe aches in hips and pelvis, loss of appetite, loss of energy which is continuing. Intestinal upset which is continuing.

some pain in my left shoulder; severe pain in my lower back; significant nausea; This is a spontaneous report from a contactable physician (patient). An 82-year-old female patient received second dose of bnt162b2 (BNT162B2) , via an unspecified route of administration on 10Feb2021 12:00 at single dose on right arm for covid-19 immunisation. Medical history included ongoing allergy to perfumes/scents, ongoing allergy to linseed oil, ongoing chronic osteoarthritis (six joint replacements), GERD, hypertension. Concomitant medication included duloxetine hydrochloride (CYMBALTA), enalapril, ferrous sulfate, gabapentin. The patient previously received first dose of bnt162b2 on 20Jan2021 11:00 for covid-19 immunisation and experienced no adverse event. The patient stated that, "I had no reaction, not even a sore arm, after the first shot. However, for two days (Feb2021) so far after the second shot I have severe pain in my lower back, some pain in my left shoulder, and significant nausea." No treatment received for the adverse events. 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. Patient was not pregnant at the time of vaccination. The outcome of the events was not resolved. Information on Lot/Batch number has been requested.

About 3 hours after shot I got diarrhea and it was bad. Pain in arm, dizziness and loss taste and i have not gotten back yet, joint pain, tiredness, fever. I have been so thirsty i have been drinking a ton of water. i had all the symptoms of covid . I had covid in November and symptoms were worse .

Bright red rash; large welts covering across butt; purple in spots; Chills; fatigue; Loss appetite; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, batch/lot number and expiration date not reported), via an unspecified route of administration (vaccine location: left arm) on 27Jan2021 10:00 for COVID-19 immunization. Facility type Vaccine: Pharmacy/Drug Store. Medical history included high blood pressure and heart surgery in past. The patient was not pregnant at the time of vaccination and at the time of reporting. The patient had no known allergies. The patient had no Covid prior vaccination. Concomitant medications/ other medications included metoprolol, rosuvastatin, and OTC anti acid. There was no other vaccine given withiin four weeks. On 27Jan2021 23:00, the patient experienced chills, fatigue and loss appetite; bright red rash and large welts covering across butt - needed to seek treatment at urgent care. It was now 4 days later and still present and purple in spots. Prescription cream (unspecified) was given. The outcome of events was not recovered. Information on the lot/batch number has been requested.

nauseated; vomited and cannot keep anything down; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 30Jan2021 14:40 at a single dose for covid-19 immunisation. Medical history included diabetes mellitus diagnosed 40 years ago. There were no concomitant medications and no prior vaccinations within 4 weeks. The patient was nauseated and vomited and cannot keep anything down starting on 31Jan2021 to the date of report. Events did not require emergency room nor physician's office visit and no treatment was received. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Patient had COVID pneumonia in January 2021. Readmitted 2/10 for nausea/vomiting found to be in DKA. Treated with IV insulin, fluids, pressors and admitted to ICU. DKA resolved but continued to have ongoing nausea and dysphagia. EGD showed possible candidiasis, GI symptoms started to improve and was discharged home 2/24 with O2, life care, home health care. Patient recorded deceased 02/26/2021.

Covid Vaccine Chronology March 8 ? 16, 2020: Hospitalized with Covid-19 Virus. Health largely restored to previous level February 25, 2021: Received first dose of Pfizer Covid Vaccine and noted a small red spot and small bump on the arm at the injection site February 26, 2021: Noted the following symptoms; Took Tylenol ? Arm swelling with the bump getting painful and redness expanding ? Very weak and body aching ? Chills and fever ? Headache and nausea February 27, 2021: Noted these symptoms: Took Tylenol ? Felt like I had the virus all over again with every bone aching ? Headache with fever of 100.5. ? Chills with shaking ? Loss of appetite ? Swelling in the arm growing larger with the bump feeling hard and more painful February 28, 2021: Noted these symptoms: ? Stomach hurt and thirsty took some Tums and drank water to relieve it ? Arm very red swollen and painful from shoulder to elbow. Pain in the bump close to level 10. Took pictures ? Still limited appetite ? Body aches ? Night sweats March 1, 2021: Noted these symptoms ? Arm still red, swollen and painful but area away from the bump becoming itchy tried ice but not very helpful ? Chills, fever and body aches dissipating ? Night sweats ? Thirsty ? Able to take a short walk outside March 2, 2021: Noted these symptoms: ? Woke up drenched in sweat ? Still very thirsty ? Labored breathing when we took a walk ? Tried heat and cold on arm which was still painful but the pain level had come down between 8 and 9 ? Saw Dr. who prescribed Traumeel to reduce the redness and swelling in my arm and told me she would do more research but at this point not to take the second dose of the vaccine after hearing my symptoms March 3, 2021: Noted these changes ? Arm still swollen and red with the bump still painful but closer to a 6 or 7. ? Saw my chiropractor, who gently massaged my body back into alignment and showed me some massages for my arm ? Was able to take a walk and the breathing was improved

Symptoms began as very tired, a bit of soreness with mild flu-like symptoms with a bit of soreness at site for 3-5 days. Some diarrhea which is still prevalent to this date (03-07-2021) . Am counter acting diarrhea with an OTC anti-diarrheal medicine. The adverse symptoms I experienced did not seem necessary to follow-up as listed in item No. 21

Patient has nausea, vomiting, severe headache and severely increased blood pressure. She reported to the ER where it was determined she had had a stroke.

had reaction in mouth broke out in tiny sores; Facial flushing; This is a spontaneous report from a contactable consumer reporting for herself. An 82-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration from 08Jan2021 to 08Jan2021 at SINGLE DOSE for covid-19 immunization. Medical history included hypertension, blood pressure abnormal, blood cholesterol increased, thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication included triamterene (TRIAMTERENE), verapamil (VERAPAMIL), levothyroxine (LEVOTHYROXINE), atorvastatin (ATORVASTATIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. Caller stated that she had her first Pfizer vaccine on 08Jan and was scheduled for her second one tomorrow. Stated that the next day in the evening that she had a reaction in her mouth that broke out in tiny sores. Stated that she went to her dental appointment and was prescribed Triamcinolone Acetonide paste and it went away. Wanted to know if this is anything that has been reported before she gets the second one. Clarified it as Pfizer Covid 19 vaccine. Is in her 80s. Stated that she also had facial flushing in 15 minutes of the vaccine that went away in 30 minutes. Concomitant Medication: Stated that she was on her regular medication. Littles sores in the roof of my mouth, dentist checked and said that sometimes vaccine can trigger like you have had cold sores or canker sores in the past. Consumer stated, "I spoke with someone earlier today and went through some side effects I had from the first Pfizer vaccine which was 08Jan. And we went through everything and she said I needed to report to someone else, a nurse or something and I decided to get back to that, she said option 3 but when I went to option 3 it was Medical, I don't know if I put the option in too soon or what. All I want to do is just report and I am having my second dose in the morning. When probed for the reference#, consumer stated, She didn't give me a reference number, but I gave her the COVID Vaccine Pfizer LOT and also gave her my email.Role of Pfizer Drug Safety was informed to the consumer. When probed for the adverse reactions, consumer stated, "I had facial flushing at the time. They had me stay for half an hour and check blood pressure and everything and then the following night I had some littles sores in the roof of my mouth and I already had a dental appointment coming up, so I went to the dentist and he checked it and said that sometimes the vaccine can trigger like you have had cold sores or canker sores in the past. Ethnicity: Consumer stated, "(Withheld) with some (withheld). Consumer confirmed vaccine name as COVID-19 Vaccine When probed for the expiration date, consumer stated, "No, but I am having a second one tomorrow. I was given at (Institute name). Other medical conditions: Consumer stated, "I have thyroid." (Not clarified further). When probed for the treatment, consumer stated, "The only treatment I had is the dentist prescribed a paste that I dab on, that I put in my mouth, but it took care of the problem I used it about five days. Consumer further stated, "My main thing was just reassurance that those can be normal because it is not listed in the side effects. I have been on phone now for at least an hour waiting my turn. I think I will go and just tell them tomorrow when I get my shot. Consumer stated, "I spoke with someone earlier today and went through some side effects I had from the first Pfizer vaccine which was 08Jan. And we went through everything and she said I needed to report to someone else, a nurse or something and I decided to get back to that, she said option 3 but when I went to option 3 it was Medical, I don't know if I put the option in too soon or what. All I want to do is just report and I am having my second dose in the morning. When probed for the reference#, consumer stated, "She didn't give me a reference number, but I gave her the COVID Vaccine Pfizer LOT and also gave her my email. Role of Pfizer Drug Safety was informed to the consumer. When probed for the adverse reactions, consumer stated, "I had facial flushing at the time. They had me stay for half an hour and check blood pressure and everything and then the following night I had some littles sores in the roof of my mouth and I already had a dental appointment coming up, so I went to the dentist and he checked it and said that sometimes the vaccine can trigger like you have had cold sores or canker sores in the past. Consumer confirmed vaccine name as COVID-19 Vaccine. Consumer further stated, "My main thing was just reassurance that those can be normal because it is not listed in the side effects. I have been on phone now for at least an hour waiting my turn. I think I will go and just tell them tomorrow when I get my shot. Consumer was provided with Pfizer Medical Information Department's number as (Phone number withheld) and was informed to press option 3 and call from 8 AM to 11 PM, Mon to Sun as per EST. Outcome of the events was recovered. The reporter considered the events as non-serious.

king size belly ache; pooped all over herself; weak and too through; severe diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reported) via medical information team. A 82-year-old female received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262, expiry dates not provided, NDC#; unknown), via an unspecified route of administration, in arm left, on 27Jan2021 14: 00, as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were none. It was reported that the patient experienced severe diarrhea on an unknown date in 2021, also reported that She got a king size belly ache the following Saturday and pooped all over herself. She is weak and too through; all events on 30Jan2021. The outcome of the event diarrhea was unknown and other events were recovering.

3-9-21 1PM PT C/O 'LIGHT BURNING IN STOMACH & MILD HEADACHE' A/O, PINK, W/D, RESP REG WITH EASE. NO SOB, NO NAUSEA, NO DIAPHORESIS. 1:05PM 'FEELS BETTER NOW'. NO ACUTE OR OBVIOUS DISTRESS. 1:10PM AMBULATORY TO EXIT- GAIT STEADY. NO DISTRESS NOTED. 3-10-21 9:30AM PT STATES'FEELS BETTER- SYMPTOMS RESOLVED'.

A few days after I received my 2nd vaccine dose on 24Feb2021, I lost hearing in my right ear; extremely light headed; nausea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6202), via an unspecified route of administration, administered in left arm on 24Feb2021 at single dose for Covid-19 immunisation. Medical history included hydrocephalus condition-corrected with surgery also wear hearing aides, and seasonal allergies on occasion. The patient was not pregnant. The patient had no known allergies. Concomitant medications included omeprazole (PROTONIX) and simvastatin (ZOCOR). The patient received first dose of bnt162b2 on 03Feb2021 for Covid-19 immunisation and experienced lightheaded and lost hearing in left ear. A few days after she received her 2nd vaccine dose, she lost hearing in her right ear and have become extremely lightheaded and somewhat nausea in 2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.

woke wet from sweat; Nausea; neuropathy was elevated to an unbearable level /neuropathy flared up; body aches; severe muscle ache; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's daughter-in-law). An 82-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date) at 82-year-old vaccination age via an unspecified route of administration in the right arm on 11Feb2021 15:30 as a single dose for covid protection (covid-19 immunisation). Medical history included transient ischaemic attack (TIA) which she has had this happen twice, thyroid removal in 1970, stroke (last doctor screwed up her medications and could have caused a stroke), has been losing a lot of weight (prior to vaccination) and neuropathy. Concomitant medications included influenza vaccine (FLU) on an unspecified date for an unspecified indication, blood pressure medicine, and hormone medication since she had her thyroid removed in 1970. The patient did not receive vaccinations within 4 weeks prior. The reporter mentioned that the patient has experienced body aches on 12Feb2021, nausea on 13Feb2021 and she woke wet from sweat on 16Feb2021. It was mentioned that her neuropathy was elevated to an unbearable level on 12Feb2021. She didn't feel it the first day. When talking about the neuropathy, the reporter stated that it was like something stabbing her from the knees to the toes. She has to lay in bed. Her legs hurt so bad she is unable to stand and can't sit for long. She woke wet with sweat twice. The first time was on 16Feb2021 and again on 19 or 20Feb2021. She had a flu shot on an unspecified date when they came out. The events did not require emergency room or physician's office visit. The reporter mentioned that her mother in law who was due tomorrow for the second dose and wanted to cancel because their doctor advised them to wait for at least a month to receive the second dose. According to her, her mother in law was sick for almost 3 weeks after the first dose, her mother in law experienced severe muscle ache and her neuropathy flared up on an unspecified date in 2021. The outcome of the events sweaty was recovered on an unspecified date in 2021, as for the event nausea was recovered on 01Mar2021 while muscle ache was unknown. The outcome of the other events was recovering. The following information on the batch/lot number has been requested.

tired; fever; general malaise; diarrhea; sweating; muscle aches; headache; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262; Expiration Date: May2021), intramuscularly, administered in left arm on 04Feb2021 12:15 pm as SINGLE DOSE for covid-19 immunisation. Medical history included neuroendocrine tumour of the lung and ongoing chronic obstructive pulmonary disease (Diagnosed 15 or so years ago). There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): N/A. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Any AE(s) did not require a visit to Emergency Room and Physician Office. It was nothing severe. Prior Vaccinations (within 4 weeks) was None. AE(s) following prior vaccinations: n/a. The patient experienced headache (non-serious) on Feb2021, fever (pyrexia) (non-serious) on 06Feb2021, general malaise (malaise) (non-serious) on 06Feb2021, diarrhea (diarrhoea) (non-serious) on 06Feb2021, sweating (hyperhidrosis) (non-serious) on 06Feb2021, muscle aches (myalgia) (non-serious) on 06Feb2021 and tired (fatigue) (non-serious) on 08Feb2021. The caller is 82 years old. She received her first COVID-19 vaccine on 04Feb2021. She was fine 04Feb and 05Feb2021. On the 6th and 7th, she had muscle aches, fever, she was sweating and had general malaise. These symptoms felt important enough to report, she doesn't know if Pfizer is keeping track of it or what. When probed for consent to contact, the caller explains the doctor she had been seeing is no longer practicing, and she just started seeing this doctor. She doesn't know how much this new doctor is going to help. Caller adds that she also experienced diarrhea. She was a little bit better yesterday, but she feels fine today. She states she maybe a little tired today, but nothing else. She is fine. Her daughter had a question that she wanted the caller to ask. These symptoms do not mean she should not get the second shot? These are pretty normal side effects, aren't they? From what she has read they are. She is scheduled for her second vaccine on 26Feb2021. Vaccination Facility Type: there is a special area roped off just giving shots to public. The outcome of events was recovered on 08Feb2021 and for event (tired) was unknown.

she has been freezing since receiving her second COVID-19 Vaccine dose; She said the last 2 days she has been very nauseous. She said she was nauseous all day Thursday, 04Feb2021; Chills; Shaking; She clarified she is always cold, but her coldness seems to be worse at night.; This is a spontaneous report from a contactable consumer. A 82-Year-old female consumer receive second dose of COVID-19 Vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,lot no: EL9262, formulation; solution for injection), via an unspecified route of administration on 03Feb2021, 10:30AM as single dose at arm left for covid-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot no: EL1284) on Jan2021 for covid-19 immunisation. The patients' Medical history included Partial knee replacement on 16Nov2020, ongoing Diabetes and Spinal stenosis. The patients concomitant medication was not reported.On 03 Feb 2021, the patient had been freezing since receiving her second COVID-19 Vaccine dose, she was nauseous all day , had chills and was shaking. The patient took Extra Strength Tylenol 500mg. the outcome of event shaking was not recovered, chills and nausea was recovered on 03 Feb 2021.

dizziness; hallucinations; disorientation; fever/she had fever again; pain in the arm/pain in left arm; loose appetite/without appetite; forgetting things and words; could not even put up a sentence; difficulty breathing; needed help to walk; needed help to get dressed and eat due to hands tremor issue; vomiting; pneumonia; stopped eating; she was always tired; sleepy; stiffness in extremities; oxygen was low; she was not responsive/following instructions; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Feb2021 08:45 on Left arm at single dose for COVID-19 immunization. Medical history included Hypertension. Concomitant medications included acetylsalicylic acid (ASPIRIN PROTEC), atorvastatin, losartan. The day of the vaccine administration she had fever and pain in the arm on 14Feb2021 20:00, next day on 15Feb2021 started with dizziness, hallucinations, disorientation. As the days went on in 2021, she started to loose appetite, forgetting things and words, she could not even put up a sentence but most importantly she had difficulty breathing, needed help to walk, get dressed and eat due to hands tremor issue. Afterwards; she had fever, vomiting, pneumonia and stopped eating, she is always tired, sleepy, with stiffness in extremities and pain in left arm. She was 1 day hospitalized and we had to bring her back to hospital because her oxygen was low, she had fever again, without appetite and she was not responsive/following instructions. All events were resulted in Emergency Room Visit and Physician Office Visit, Hospitalization for 1 day. Treatment received for the events included Oxygen, fluids, antibiotics. Lab data also included covid test type post vaccination=Nasal Swab on 01Mar2021 with Negative result. The outcome of the events were not resolved. Information on the lot/batch number has been requested.

Severe ringing in ears was followed by burning sensation starting in abdomen, then to legs and then to upper body. This happens every night about one hour after sleep. I have no fever. But I feel like I am in an oven. Subsides about one hour later but extreme tinnitus continues. During the day I feel hot but not the same intensity of the nightly attacks. Never had this before. I had a second shot on 2/26 and on that night it was very severe. Still suffering to this date. Primary doctor does not know what I have. Blood work negative except for two positive Ana antibody tests.

nauseous/ queasy/ Terribly nauseous; tired/ fatigue; slept right through the night; This is a spontaneous report from a contactable consumer or other non hcp. A 82-year-old female patient received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 31Jan2021 as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing Verbatim: Diabetic, thyroid disorder from an unknown date and unknown if ongoing Thyroid medication. Concomitant medication included levothyroxine (LEVOTHYROXINE) 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; simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported; (OCUVITE) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced nauseous/ queasy/ terribly nauseous, tired/ fatigue, slept right through the night. The patient underwent lab tests and procedures which included weight fluctuation: 112, 110, 111 on It's about 112 pounds, once day it's 110, 111 it depends on (incomprehensible word). The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was unknown. Information on the lot/batch number has been requested.

4 a.m. 2/25/21, 1-degree fever lasting 4 days, swollen face 1 hour, joint pain first day, weakness 10+ days, diarrhea for 3 days starting 1 week after shot,

Side effects started day 2 after vaccine administration. Pt started with fever, vomiting, abdominal distension, spot where she had previous hernia surgery was bothering her. She spent a whole day in bed and then felt better. Just follow home care treatment.

Pt states hx of anxiety and was throwing up with abdominal painprior to arrival as well. Given 4 mg SL zofran with mild relief of nausea, abdominal pain persisted: Pt presents with nausea/vomiting which she attributes to anxiety. States she has had severe anxiety about getting vaccine and has been vomiting with abdominal pian throughout the day. She is noted to be extremely hypertensive today, denies hx of hypertension. She was given 4 mg SL zofran with resolution of nausea however abdominal pain and hypertension did not resolve. Of note, pt has a hx of Whipple procedure Nov 2019 and reports she has had intermittent abdominal pain since that time. Report called and pt escorted via wheelchair to the ER

COVID Vaccine I got my #2 Pfizer last Tuesday Apr 6....no problem at all with #1. The vaccination was in my LEFT arm, and the 1st day or so I didn't really have anything but tiredness. But the last few days have been very painful. I developed swelling on the RIGHT side of my face starting at the temple. That progressed down to the ear area the next few days and was quite painful. Since Saturday my tongue, lips, gums became swollen resulting in barely being able to swallow. Also rash developed and is getting worse. Additionally I ache all over and feel like a very bad case of the flu. I tried Tylenol Extra Strength in the beginning, but that seemed to only ease the pain for about an hour. Now I'm using Advil, which helps for several hours. Is there anything I can do to get relief. This is the 8th day....and it seems to be getting worse instead of better.

blood in urine abdominal pain R31.9 - Hematuria R31.0 - Gross hematuria N32.89 - Bladder mass R10.2 - Suprapubic pain, acute

Large hemorrhagic stroke with severe headache & throwing up. Not sure when it actually happened but found her on bathroom floor when I woke up. Transported to local hospital & transported to Neuro icu at major hospital. Now in nursing home with rehab. Unable to assist yet with much therapy. Impaired vision, can't feed herself or sit unattended. Very groggy & sleepy. Never lost consciousness.

This all happened after the second shot I felt nothing except a sore arm after the first shot. I immediately felt dizzy and nauseous. Nausea continued for days--intermittently for 3 weeks. Severe headache, muscle and joint pains, fatigue. Very very cold the fist night. slight fever. In the morning my nightgown was soaking wet. Headache persisted for a few days. Eventually loss of tast but that returned. The only thing that persists is intermittent fatigue and nausea.

Pt sitting for her 15 minute post vaccine period. At end of 15 minutes she was noted to become less responsive and slump in her chair. Speech not clear, could not keep eyes open. Appeared pale and clammy. Lightly retching but did not vomit. With 2 assist were able to get patient to wheechair and then to gurney nearby. BP immediately taken - it was ~ 165/80. Pulse = 70. Pulse ox = 94%. Her color remained somewhat pale. Pt able to talk more clear and state she is a diabetic and requests glucose check. We called a "first responder". Glucose machine arrived and her glucose was noted to be 287. She notes it has been "very up and down lately" and recently made changes in her insulin/med regimen. She states she did eat breakfast and took both her long and short acting insulin. She did eat a cracker and then after ~ 20 minutes wanted to sit up. She sat up and appeared improved but not 100%. Her BP sitting up was ~ 125/70. Pulse remained 70. She then stood up to get into wheelchair but once in wheelchair began to become less responsive again and appeared more pale. She was then put back on gurney with assist of 3 and taken to ER. Per ER note, she did have some vomiting and dizziness. Her BP was initially 222/99. BP improved to 1178/84. She was given meclizine and rested. She felt improved and able to ambulate, and was dc'd from ER.

vertigo; Fatigue; muscle pain; stomach cramps; Diarrhea; mucus from sinus; This is a spontaneous report from a contactable other Non- HCP. A 82-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL9261) via unspecified route of administration in left arm on 06Feb2021 (at the age of 82-Year-old) for COVID-19 immunization. Medical history included diabetes, high blood pressure, overweight. The patient was not pregnant. Concomitant medication included ezetimibe 10 mg once daily; metformin 1000 mg twice daily; acetylsalicylic acid (ASPIRIN) 81 mg once daily; chromium picolinate, cinnamomum verum bark, colecalciferol (CINSULIN ADVANCED STRENGTH) (medications in two weeks). No other vaccine in four weeks. The patient previously took first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL1283) in left arm on 16Jan2021 for COVID-19 immunization. On 06Feb2021, patient experienced muscle pain, fatigue, stomach cramps and diarrhea, mucus from sinus, vertigo. No treatment was received for events. No COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.

Severe nausea; weight loss; stomach pain; bladder infection; This is a spontaneous report from a contactable Nurse (patient). An 82-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:30 (Lot Number: EN6208) as single dose (at the age of 82-years-old) for covid-19 immunisation. Medical history included tachycardia, hypothyroidism and Covid prior vaccination (date unknown). Concomitant medications in two weeks prior to the vaccination included metoprolol succinate (TOPROL), levothyroxine sodium (LEVOXYL). The patient previously took sulfamethoxazole, trimethoprim (BACTRIUM DS) and experienced drug hypersensitivity. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 30Mar2021 patient experienced severe nausea, weight loss, stomach pain and bladder infection. Patient had three visits to primary care doctor (dr), one clinic visit for intravenous (iv) fluids, emergency room (ER) Visit and hospital admission. Patient was admitted for three days in response to the events (dates were not provided). 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 underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 14Apr2021 and sars-cov-2 test (Nasal Swab) negative on 16Apr2021. Patient had not recovered from the events, at the time of the report.; Sender's Comments: Based on the available information it is unlikely that BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) contributed to events occurrence. The reported events more likely represent intercurrent medical conditions unrelated to Covid-19 vaccination. 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.

chills; fever; achy joints; headache; metallic taste; loss of appetite/lost appetite/no appetite; very weak; tired; uncontrollable teeth chattering; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 9266), via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 82-years-old) at a single dose for covid-19 immunisation. Medical history included Hashimoto disease and known allergies: penicillin. Concomitant medications patient received in two weeks included nebivolol hydrochloride (BYSTOLIC); rosuvastatin calcium (CRESTOR); levothyroxine. The patient previously took first dose of BNT162B2 (Lot number: EN-5318) on 25Jan2021 at 02:15 PM in the left arm at a single dose for covid-19 immunisation. On 20Jan2021 at 09:00 PM, the patient experienced chills, fever, achy joints, headache, metallic taste, loss of appetite which lasted for 2 days. On the 5th day after vaccine, I lost appetite again felt very weak and tired all day and by evening I spiked a fever 102.2 with uncontrollable teeth chattering. The same occurred 6th day, metal taste, no appetite, fever 101.2. Today is 7th day, still no appetite and temp are normal. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.2 on 20Feb2021, 101.2 on 21Feb2021 and normal on 22Feb2021. The patient was recovering from all the events.

Pt presented to the emergency room 4/19/21 in the evening c/o the sudden onset of severe dizziness, light-headedness, nausea and diaphoresis. She received her second covid 19 vaccination at 10am earlier that day. pt was brought in via ambulance. she had a past history of vertigo but felt this incident was very different than her past episodes. she denied any problems with the first vaccine dose. she was admitted with a near syncopal episode and observed overnight in the hospital on telemetry. she was discharged home the following day feeling better with improvement in the dizziness. orthostatic blood pressures were negative.

stomach pains; diarrhea; Sore Arm; This is a spontaneous report from a contactable consumer (patient). An 82-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of the Pfizer Covid Vaccine (BNT162B2) on 16Mar2021 (lot number: EP7534) at 82-years-old for COVID-19 immunization and had sore arm from first vaccine. The patient experienced sore arm from second vaccine on 06Apr2021 and stomach pains and diarrhea on 08Apr2021 at 17:00. The reporter stated she had the second dose of the vaccine on Tuesday (06Apr2021). On Thursday (08Apr2021) she got severe stomach pains and had diarrhea for an hour and half straight. Later that morning it happened, and at 3:30, 4:30 and between 6:00 and 7:00. It happened 6 times and just poured out of her. She had been ok since that. It was really bad. She asked if this is a side effect of the vaccine. The events didn't require a visit to Emergency Room or Physician Office. The patient called physician this morning. Treatment of the event sore arm included Arm Tylenol. The outcome of the event sore arm was recovered on 08Apr2021. The outcome of the other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

could hardly walk; arm was very sore; stomach was upset; Slight Headache; Diarrhea; Slight fever; Muscle ache; felt bad; Sore throat; bled after her injection; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8727), via an unspecified route of administration in the left arm on 25Mar2021 between 15:30-16:00 (at the age of 82-years-old) as a single dose for COVID-19 immunization; apixaban (ELIQUIS) via an unspecified route of administration at 5 mg twice a day from an unspecified date in 2018 and ongoing as a blood thinner/for the heart. Medical history included diabetes (started a couple of years before 2018), arthritis, lupus since 2020 (started just 6 months ago), high cholesterol, heart disease, all ongoing; as well as aortic valve replacement and pacemaker in 2016; she had all 3 types of arthritis: osteo, rheumatoid, and the one with the rashes, she has had aches and pains for a long time; arthritis pain; heart surgery in 2016; COVID-19 in the last part of Jul2020 to the first 2-3 weeks in Aug2020 (and then tested negative on 19Aug2020) with the following symptoms: bad headache, muscle aches, diarrhea, loss of smell and taste, "just about everything" for almost 4 weeks, autoimmune disease, diuretic and muscle relaxant therapy. Ongoing concomitant medications included glimepiride for diabetes from 2014, potassium tablet as a diuretic from 2016, furosemide as a diuretic from 2016, metoprolol for the heart from 2016, atorvastatin for cholesterol, hydrocodone for pain, tizanidine as a muscle relaxant, cinnamomum verum (CINNAMON) capsule, ascorbic acid (VITAMIN C), fish oil, ubidecarenone (COQ-10), vitamin D3, paracetamol (TYLENOL ARTHRITIS PAIN) tablet for arthritis pain, and an unspecified multivitamin. There were no additional vaccines administered on the same date or 4 weeks prior to BNT162B2. On25Mar2021, the patient bled after her injection, the blood started running down her arm when they pulled the needle out. The patient experienced sore throat on 25Mar2021 at 22:00, which was not excruciating, and the patient did not take anything for it. After waking the next morning, the sore throat was gone. The patient took paracetamol daily in the morning, and she wasn't sure if that was why her sore throat went away or not. She stated that when she had COVID disease the paracetamol didn't help her sore throat or headache at that time. The patient then started to have muscle ache on 26Mar2021 and a slight fever, never over 98 degrees, and she felt bad. The patient's normal temperature was around 97 degrees. The patient experienced a slight headache on 27Mar2021, diarrhea for 1 day and stomach upset on 27Mar2021 and then diarrhea again on 31Mar2021 for 1 day. The patient didn't take anything for the diarrhea, it was not that severe. The muscle aches continued in the upper part of legs, thighs, upper arms to her elbows. The patient had never had a hurting like that in her muscles and on an unspecified date, the patient could hardly walk since it was hurting so bad. On an unspecified date, the patient's arm was very sore. The events did not require an emergency room or physician office visit. The patient did call her doctor because she was hurting so bad who informed her that he had heard of other people who had the disease were having a reaction to the first vaccine. The action taken in response to the events for apixaban was dose not changed. The clinical outcome of sore throat was resolved on 26Mar2021 (duration 1 day), muscle ache was resolved on 03Apr2021 (duration 8 days), slight headache was resolved on 04Apr2021 (duration 8 days), diarrhea occurring on 27Mar2021 was resolved on 28Mar2021 and diarrhea occurring on 31Mar2021 was resolved on 01Apr2021, slight fever was resolved on 26Mar2021 (duration 1 day), stomach was upset was resolved on an unspecified date, and of could hardly walk, arm was very sore, bled after her injection, felt bad was unknown. No follow-up attempts are possible. No further information is expected.

Second shot, cold light temp, diarrhea, injection site pain, arthritic knee hurt badly- felt fuzzy and lightheaded for everyday since shot. Added 5/7 some days super duper tired Pfizer 03/13/ 2021 left arm. No medicine, has arthritis,

Patient is an 82 y/o female with PMHx of HTN, HLD, COPD, CAD s/p CABG, AFlutter post CABG who presented to the ED c/o generalized malaise, nausea, diaphoresis, dizziness, and a HA after her first Pfizer COVID vaccine on 4/22/21.She presented in Aflutter with RVR. She converted to sinus rhythm s/p IV Diltiazaem. She was evaluated by Cardiology and cleared for discharge on Multaq, diltiazem, carvedilol, ASA, and Eliquis. Echo showed LVEF 65%. Mild MR. Moderate TR. Her symptoms resolved on the day of discharge. She is to follow up with Cardiology.

Headache; stomach cramps; pain in legs and weakness; pain in legs and weakness; not hungry; arm pain; This is a spontaneous report from a contactable consumer. An 82-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 05Feb2021 at 12:30 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included hypertension. Concomitant medication included lisinopril. On 05Feb2021 at 21:00 patient started experiencing headache, stomach cramps, pain in legs and weakness, not hungry, arm pain. The patient did not received treatment for the events. At the time of the reporting the patient had not yet recovered from the events. Follow-up attempts are completed. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received first dose of bnt162b2 (COVID-19 VACCINE, solution for injection, Lot Number: ER8737; Expiration Date: Jul2021, NDC number: Unknown), via an unspecified route of administration on 07Apr2021 (at the age of 82-year-old) at single dose for COVID-19 immunisation. Medical history included had headaches most of her life, she knew it was her cervical spine because of bone spurs, arthritis, and bulging disc; she has also had change in vision, she was coming down the road from seeing her cardiologist and was looking down the road, out of right eye the road continued straight, but out of her left eye it looked like the road was turning off to the left, it was actually going straight, her eye doctor had told her that her eyes were no longer compatible, she was having five prisms put in her glasses, the neurologist was concerned, the eye thing started four or five months ago; she had shrunk to 4 foot 10 inches or 4 foot 11 inches, she used to be 5 foot 2 inches and shrunk because she had osteoporosis. The patient's concomitant medications were not reported. Patient reported that she had diarrhea one day in Apr2021. She started coughing some yesterday (14Apr2021). Then she was coughing more a little later. That was not what she would normally do. 14Apr2021, she was moving her winter clothes out to her summer clothes. She worked for three to four hours. Then she got so sore and was hurting all over. She felt the same this morning (15Apr2021). She was wondering if muscle aches could be a part of it. She was really hurting last night (14Apr2021) all over. She woke up this morning and felt sore. She was better now. It was from the waist up to the rib cage and all the way around. It was general, all over. She felt so badly last night (14Apr2021) and didn't feel great this morning. Another reason she was calling was because she saw her neurologist three days before and he scheduled her for an MRI of her head and brain. She had the appointment for the MRI on the 21Apr2021. She had been told that particular test was a magnet test and not radiation. She wanted to make sure there was nothing in the vaccine. They were not sure what the vaccine was going to do. They were not sure what was dealing with. Diarrhea started a couple of days before in Apr2021 when she was out of town, just for one day. It had stopped, she had recovered completely from the diarrhea. Coughing started on 14Apr2021. It was kind of a deeper cough. She had a little coughing 15Apr2021, but mainly body aches that started late 14Apr2021. She hobbled around and went to bed and got up to go to the bathroom and was having a hard time walking because she was so sore on 14Apr2021. The soreness was all over the body. She was having the MRI on her brain and head because she had been having headaches in Apr2021. She has had headaches most of her life. She had seen him (neurologist) several years before. She knew it was her cervical spine because of bone spurs, arthritis, and bulging disc. The doctor said that was the reason for a headache, but this was a different headache. It extended from behind her eye on the left side to the back of her head. It came on suddenly and she would have it for two to three days. Then that side of the head when she was turning in the left direction was sore and hurts. The headaches that felt different had been on and off for the past several months. She would have them for 3 days running and then maybe get a reprieve. She didn't want to take the second vaccine and had that on top of each other with the MRI. She wondered if she could take the second vaccine a little later. She was not comfortable getting it around the same time of the MRI. The outcome of the event diarrhea was recovered in Apr2021, sore was recovering, outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.

Lightheaded and feels like she may faint; Cold Sweats, then Freezing; Cold Sweats, then Freezing; Diarrhea; This is a spontaneous report from a Pfizer- sponsored program. A contactable consumer (patient) reported that an 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration administered in right arm on 09Apr2021 (Lot Number: EW0150) as single dose for COVID-19 immunisation. Medical history included ongoing Parkinson's disease started 5 years ago or more. The patient's concomitant medications were not reported. The patient took the first dose of BNT162B2 (lot# EL9267) on 12Mar2021 and second dose 09Apr2021, which was technically more than 21 days, it was 4 weeks. The patient was very sick and experiencing diarrhea on 12Apr2021, diarrhea was better last night on 14Apr2021 and she was feeling pretty good when she went to bed and then it is back with a vengeance this morning. The patient took 2 Imodium and then she had another episode of diarrhea so she took another one. The patient experienced lightheaded and felt like she may faint, cold sweats, then freezing on 15Apr2021. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

Lite nausea and tired the next day; Lite nausea and tired the next day; This is a spontaneous report from a contactable consumer. An 82-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration in right arm on 29Jan2021 01:45 PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not on other medications. The patient was not diagnosed with COVID-19, prior to vaccination. On 29Jan2021 at 7:00 pm, the patient experienced Lite nausea and tired the next day. The patient has not been tested for COVID-19 Since the vaccination. There was no treatment received for adverse events. The outcome of events was recovered. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Dizzy, head pressure, increased sleepiness, headache, nausea, congestion, ringing in ears, chest pain

Encounter Details Date Type Department Care Team Description 04/22/2021 - 04/29/2021 Hospital Encounter Acute respiratory failure with hypoxia (Primary Dx); Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present; Pneumonia due to COVID-19 virus; Pneumonia due to 2019-nCoV; Simple chronic bronchitis Details of the Hospital Course: Patient is a 82 y.o. female with COPD follows with the respiratory disease specialist outpatient, history of mediastinal mass s/p VATS procedure done by Dr. in June 2011, pathology came back benign thymoma, she subsequently developed a slowly growing posterior mediastinal recurrence that was resected by Dr. in June 2016 and was felt to represent "recurrent/metastatic thymoma?type AB", with surgical margins < 1 mm; she declined postoperative XRT, last seen by Dr. in April 2020 recommended repeat CT in 1 year for evaluation who presented to the ER on 04/22/2021 with complaints of shortness of breath, found to be hypoxic on room air with pulse ox of 87% and found to be positive for covid 19 (of note: patient received her first COVID 19 vaccination mid April). Chest xray showed radiographic evidence of pneumonia in RLL but without evidence of acute PE on CT scan. Patient was requiring 15 L of supplemental oxygen to maintain oxygen saturations and so was placed on high flow nc with better response 4/23 remained on HFNC 4/24 BCx from 4.22.21 growing out gram positive cocci in 1/2 bottles 4/26 HFNC at 50% and 45L 4/27 off HFNC and on 6 L NC/ awaiting PT evaluation 4/28 per, OT assessment -- pt dropped into 70's on 6L 02 with short walk to bathroom and toileting tasks. cues for rest and PLB needed to increase 02 into 80s. with a seated rest break over 5 mins 02 increased to 88% on 6L COVID pneumonia (first dose of Pfizer vaccine mid April) S/P remdesivir X 5 days, now on day 8/10 decadron but will go home on oral decadron Acute hypoxic respiratory failure slowly improving (not on home oxygen therapy) now off HFNC, was on 10 L oxymask. Patient's pulse ox this morning at rest on 4 L was 86% but improved to 92% on 5 L NC -will need 5L home oxygen therapy at discharge (new) -discussed the need to follow up with Dr or PCP to wean off supplemental oxygen. Patient agreeable with this plan Transaminitis levels trending downwards. History of thymoma s/p VATS 2011 -outpatient follow up Positive blood culture on admission, contaminant in 1 of 2 blood culture bottles. Repeat blood cultures showed no growth. Not on antibiotics Associated attestation - 04/22/2021 3:39 PM EDT Formatting of this note might be different from the original. Patient seen and examined. Current status reviewed with resident staff. I have reviewed pertinent physician documentation, laboratory and radiographic data. I have initiated therapies based upon this reviewed In brief 82-year-old woman with history of COPD, mediastinal mass status post VATS with benign thymoma with local recurrence presented with respiratory tract symptoms since 6 days prior to admission COVID testing is positive. In the emergency room she was noted be hypoxemic requiring 15 L of supplemental oxygen to maintain oxygen saturations. She is currently on high-flow feels much improved. I concur with exam as per Pulmonary fellow. Laboratories and imaging reviewed in detail. Impression COVID-19 infection COVID-19 pneumonia Severe hypoxemic respiratory failure requiring high-flow oxygen Thrombocytopenia which is new since 2016 and a poor prognostic sign History of benign thymoma with local recurrence COPD with exacerbation Doubt bacterial pneumonia Recommendation: Remdesavir 5 days Corticosteroids. Optimum dosing induration of corticosteroids has yet to be fully defined. Decadron 6 mg daily is reasonable however if develops progressive disease in the next 24 hr would escalate corticosteroids and would also add IL 6 inhibitor Additional minerals and vitamin supple role is unclear but probably benign If thrombocytopenia worsens may need alternative anticoagulation. Would check venous Dopplers Supplemental oxygen for saturations greater than 88% Daily PPI unless anticoagulation intensified then would go to q.12 hours Would favor discontinuing antibiotics

She has not eaten anything; Diarrhea; This is a spontaneous report from a contactable consumer (patient) received through Pfizer sponsored program. A 82-year-old female patient received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Formulation: Solution for injection, Batch/Lot number was not reported) via, an intramuscular route of administration, administrated in left arm on 22Jan2021 at 10:00AM as 1ST dose, single for COVID-19 immunization. The patient medical history included as diabetes. The patient concomitant medications included as Metformin two tablets in the morning, and one tablet at night by mouth taken for diabetes. On 27Jan2021 patient experienced with diarrhea and patient was calling about the Pfizer Covid vaccine. Everything was fine. Patient had the corona virus first shot on 22Jan2021. On 27Jan2021, the patient experienced diarrhea. On an unspecified date, the patient patient had not eaten anything today. Patient had diarrhea for a day or two. Patient called her doctor for an appointment and Patient was told that diarrhea was a sign of the coronavirus and that patient should go to urgent care. Patient was asking if this was true. patient was confused and in shock, now patient was scared patient may have coronavirus. patient was told that even though patient had the shot could still have the coronavirus. Patient had diarrhea once or twice. patient not had any diarrhea today but patient had not eaten anything today. Patient had to go back 13Feb2021 for the second shot. Patient was not given a card and patient cannot provide lot, ndc, or expiration date. Patient called the doctor and they said no they wouldn't see her because that is a sign of the coronavirus and wants to know if that is true since she already had the first shot. No further details provided. Unable to provide an email address. Declines report and wants to speak to someone about this. The outcome of the event resolved on 29Jan2021 and outcome of remaining event was unknown. Information about lot/batch number has been requested.

fever of 101; joint pain; diarrhea; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318), via intramuscular route of administration on 26Jan2021 at 10:00 (at the age of 82-year-old) as first dose, single in left arm (shoulder) for COVID-19 immunization. The patient's medical history included breast cancer. Concomitant medications were not reported. Patient was healthy before vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jan2021 at night, on the day of vaccination, the patient had diarrhea. On Wednesday she felt fine. On 28Jan2021 Thursday, the patient experienced joint pain, on only her thigh in the left leg and noticed fever which was at 100.1 on 31Jan2021, Sunday morning. Patient took aspirin and it went down. On 01Feb2021, her temperature was normal and was 97.5 degrees Fahrenheit. The patient underwent lab tests and procedures which included body temperature: 100.1 Fahrenheit on 31Jan2021, body temperature: 97.5 Fahrenheit on 01Feb2021, which was normal. The clinical outcome of the event joint pain was recovering and outcome of all other events was recovered. Follow-up attempts are completed. No further information is expected.

Chills, Fever, sore throat, running nose, constipation, Diarrhea, shortness of breath, muscle cramps in both legs, muscle aches in all parts of body. Each symptom was not severe except muscle cramps. Muscle aches and shortness of breath still happening.

"hemorrhaging out" from her rectum/this time was the worst; "hemorrhaging out" from her rectum/this time was the worst; received second bnt162b2 on 21Jan2021; This is a spontaneous report from a Pfizer- sponsored program via a contactable consumer. An 82-year-old female patient (reporter's mother) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included rheumatic fever when she was 3 years old, open heart surgery for valve repair in Feb1982, open heart surgery for mitral valve replacement with artificial valve in 1993, type 2 diabetes started coming on by 2000 but it was not adequately addressed and treated until probably 2005, Heart failure maybe had it since at least 2000 and it got worse, sepsis from an infection, lymphedema from 2011 (that was treated with a black box antibiotic which ended up destroying the balance in her brain and then she was no longer able to drive, walk without a walker or assistance from someone, and that's when the heart really became more serious with the heart failure in 2011), high blood pressure. Height: Caller says her mother may have shrunk a little bit with age. Weight: 145 to 148 pounds. Caller says for her mother's medical conditions she had rheumatic fever at age 3 and she was hospitalized for almost 3 years in a trial when they didn't have a treatment. They finally put her in the Hospital for 6 months and gave her penicillin shots every week and she was told to have no physical activity until she was 18 years old and then they stopped the penicillin shots and they didn't anticipate that she would live long. So she has always had trauma from that to her heart. Concomitant medication included warfarin sodium (COUMADIN) from 1982 and ongoing for blood thinner. The patient previously received the first single dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 for covid-19 immunisation. Caller reported that while she has had hemorrhoids in her history and has unaddressed issues found in a colonoscopy, on 09May2021 in the morning her mother experienced "hemorrhaging out" from her rectum causing her to be admitted to the hospital. Reporting that she was just released on 17May2021. Caller vocalizes concern that, because her mother required blood transfusions during her hospitalization, the vaccine efficacy may have been affected and she asks if given her mothers situation, she should get an additional dose of the vaccine? During this call she mentioned that both of her parents received both doses of the vaccine and experienced none of the common side effects. Caller states that her mother was hemorrhaging blood and when she was at the hospital they immediately got her on blood. The caller is unsure if the blood was originally received in the ambulance or in the hospital. When she got to the hospital her hemoglobin was 8 and they did a blood transfusion and she got 2 bags of blood. Event Details: On 09May2021, her mother began hemorrhaging at that point and she had tried to go to the bathroom because she felt like she was going to leak more and when she had went to the bathroom, which is not a long distance maybe about 6 feet, at the entrance of the bathroom her mother described it as she couldn't hold it and blood poured out of her. This has been an ongoing issue that her mother has neglected to take care of by getting a colonoscopy for the past 4 years and she has been bleeding all this time but never to this extent. The caller didn't think that her father realizes how close she was to death. Caller confirmed that her mother has been bleeding since before the COVID vaccine but it was nowhere near as bad as this, this time was the worst. For the past month or so her Coumadin levels have been going up and down and her bloodwork was not coming back right away and her primary care provider, mentioned above, hasn't done much for this. For the caller and her mother it is very discouraging. If her mother saw the heart doctor then all of this probably could have been prevented and if the blood thinner was working correctly. They have dealt with all of that at Hospital but her mother puts things off, she is stubborn. The caller thinks that the lengthy hospital stay and being so close to death maybe scared her mother a bit. The only thought was that her mother's blood thinner hasn't been balanced correctly for the past month and that was something that was concerning but her doctor, wasn't taking it very seriously. Her mother has been on Coumadin for a long time and when they did see her and did the bloodwork it showed that her blood thinner was extremely too high and that would explain why this episode of bleeding was so much worse than the previous ones. The outcome of the events was unknown. Information on the lot/batch number has been requested.

I had 100.2 temperature; Fever/ temperature in evening; Fatigue; Headache; Nauseous; Light-headed; Chills; This is a spontaneous report from a contactable consumer (Patient). An 82-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205) via an unspecified route of administration, administered in Arm Left on 04Mar2021 10:30 (at the age of 82-years-old) as a first dose, single dose for covid-19 immunisation. The medical history included intolerant of iodine, shellfish, slight high blood pressure and known allergies: Comparing. The concomitant medication included 2 mult, levothyroxine sodium, losartan, HCTZ and pravastatin. The patient previously took morphine, demerol, darvocet, oxycodone hydrochloride; paracetamol (PERCOCET) and experienced allergy for all of them. The patient not received other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient reported, she had the first shot of the vaccine on 4th which was Thursday of March 10.30, 10:45 in the morning or 10:45. She had 100.2 temperature and seem to get temperature at night, chills, fatigue, nauseous and headache, lightheaded. It's getting better, took an Advil yesterday one and day before one, helps the fever, the temperature. Her second shot is scheduled for the 25th of March. Just want to know what to do. The patient not received treatment for the other events. The patient did not have COVID tested post vaccination. The outcome of the events chills, light-headed was unknown and the outcome of the events fever, fatigue, headache, and nausea was recovering. No follow-up attempts are needed. No further information is expected.

Patient is a 82 y.o. female with history of adenocardinoma left lower lobe lung s/p radiation, COPD, nocturnal use of 3 liters oxygen, dementia, eliquis for hx dvt, esophageal stricture who presents today from clinic secondary to hypoxia. History obtained from daughter bedside and chart review as patient has dementia. Patient began feeling ill one week ago. Complains of cough, congestion, wheezing, shortness of breath, mild wheezing, chest discomfort with coughing, fatigue, and decreased energy. She has had one episode of loose stool. Denies fevers, chills, loss of taste/smell. She was evaluated by pulmonology on 5/25 and noted to have oxygen desaturation. She was recommended to go to the ED for further evaluation however patient refused and preferred home treatment. She was prescribed Augmentin for possible aspiration pneumonia as well as prednisone taper. Patient reportedly felt some mild improvement since starting treatment however continued to require use of 3 liters of oxygen during day and night rather than just at night. She followed up with clinic today where she continued to have oxygen desaturation despite supplemental oxygen and chest xray noted new infiltrate. She was again recommended to go to the ED for further evaluation and management at which time patient agreed.

Felt like crap; Sore throat; Tired; Achy; Nausea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH CPVID-19 VACCINE; solution for injection; lot number was not provided), via an unspecified route of administration on 01Mar2021 (at the age of 82-years-old) as 2nd dose, single dose for COVID-19 immunization. Medical history included direct exposure to granddaughter who tested positive for COVID-19 in Apr2021. The patient's concomitant medications were not reported. The patient previously received the 1st dose of BNT162B2 (lot number was not provided) on an unspecified date for COVID-19 immunization. In Mar2021 (3-4 days after the vaccination), the patient experienced side effects. She felt like crap, sore throat, tired, achy, and nausea. The patient mentioned that she was fine on the first few days. The patient reported that her granddaughter, who was 10, had tested positive for COVD-19 in Apr2021. The patient has been around her granddaughter who tested positive for COVID-19. The patient wanted to know if she's immune since she has had both doses of the vaccine. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

bothers her is that her problem remembering words is getting worse./: Knees hurt was reported as worsened.; it started from the top of her neck and her balance was off, she felt "fuzzy-headed"; She has been experiencing periods of tiredness where she does not want to do anything; increased forgetfulness in addition to her intermittent light headedness; increased forgetfulness in addition to her intermittent light headedness; Was cold; diarrhea; her knees hurt her; chills; mild fever; her arm was hurting; Arm was just a teensy bit sore at the injection site; Felt a little like balance was off; So tired I don't want to do anything; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6199, Expiration date: Jun2021), via an unspecified route on 13Mar2021 (age at the time 82-year-old) as 2nd dose, single dose in the left arm for covid-19 immunization. The patient medical history included osteoarthritis, fibromyalgia (reported that she was diagnosed with fibromyalgia close to 20 years ago, between 15-20 years ago). The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9269), via an unspecified route on 20Feb2021 at 10:00 (age at the time 82-year-old) as 1st dose, single dose in the left arm for covid-19 immunization. On 13Mar2021, the patient experienced armed was hurting, armed was just a teensy bit sore at the injection site, and the next day, on 14Mar2021 she had diarrhea and her knees hurt her and had chills and mild fever, was cold and felt a little liked balance was off. Patient reported that the next day, 15Mar2021, she was fine, on 16Mar2021 it started from the top of her neck and her balance was off, she felt fuzzy-headed, fuzzy headed feeling was now not so much, but she would have a day where she was so tired that she doesn't wanted to do anything. Patient experienced periods of tiredness where she did not want to do anything was reported as worsened and reporting increased forgetfulness in addition to her intermittent light headedness. Patient reported that she called the pharmacist who informed her that some reactions would go on for a few weeks. She reported that she was a senior, and most seniors had a problem where they couldn't remember a word then blinked and could've thought of it. She reported that the thing that bothers her was that her problem remembering words was getting worse and the problem remembering words had gotten worse from her baseline after she received the covid-19 vaccine, but it had stayed the same since originally worsening from baseline. Patient reported that the difficulty remembering words worsened around the same time that her fuzzy or lightheaded feeling began, and temperature was 99. 7. Patient explained that her armed did tended to hurt a little and that she received her shot in the affected armed and she was not sure if the diarrhea lasted the second day or not, but it resolved completely. she had a teeny problem with her knees and the covid-19 vaccine really nailed it. She reported that since she received the second dosed of the covid-19 vaccine, her knees had been terrible. She reported that what's really bothering her now was her knees. She reported that her knees were hurting so bad that she could've hardly walked. It was reported that patient visited to physician office. The outcome of the events diarrhea was resolved on Mar2021, armed was hurting was resolved on 14Mar2021, chills, mild fever, cold was resolved on 15Mar2021, felt a little liked balance was off was resolving, her knees hurt, so tired I did not want to be done anything was not recovered and other events was unknown. Information on lot/batch number was available. Additional information had been requested.

The morning after I received the vaccine, I started feeling tired and my arm was quite sore. The following day, I had a fever of probably 100. I had chills and my heart rate and blood pressure went up. Since I have A-Fib, it was irregular. After several hours, my HR went back to normal and that is when I called my Cardiologist NP. She said that she thinks it's related to the fever I had. The next day, I felt a tad better, but fatigue and generally not feeling well lasted a few days. I feel that it took about a week before I felt normal again. About two months later, I was making plans to go out of town and I became very ill. I started having chills, fever, nausea and extreme fatigue. I may have taken some Tylenol. I was drinking a lot of water because I did not have an appetite. A couple days later I felt a little better so I did not contact my doctor, but I did go to an urgent care (05/22/2021) and had a COVID test. The test came back negative and I felt better two days later. On Monday, I started feeling bad again and I contacted my PCP, and I went to see him on Tuesday. He ran some blood tests and another COVID test, which came back negative. The fatigue just stayed around for quite some time. He monitored my sodium and chloride and they were both low so the doctor wanted them monitored. I was admitted into the hospital for two days. I was on liquid restriction. I had a bunch of tests ran that came back negative. I did have an AMA test which did come back positive. I am still on water restriction, but I am feeling much better. I'm a bit leery about receiving a booster shot.

Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9262) via an unspecified route of administration, administered in left arm on 29Jan2021 at 12:00 (at the age of 82-year-old) as 1st single dose for COVID-19 immunisation. Patient medical history included high blood pressure (HI BP), osteoporosis, blood cholesterol increased, all from an unknown date and unknown if ongoing. Patient had no known allergies. The patient concomitant medications taken in two weeks of COVID-19 vaccination included pravastatin (PRAVASTATIN), hydralazine (HYDRALAZINE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), all taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that on Day 2, 30Jan2021 at 05:00, the patient had pain in left arm, could not lift coffee cup, lower back pain was off and on. Event gone on Day 4, but 'now' patient was nauseous and lightheaded and back pain was back but higher up. Patient received no treatment for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was reported as resolving and outcome of the event pain left arm was resolved on 01Feb2021. Follow-up attempts are completed. No further information is expected.

fatigue; mild stomach issue; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 01Feb2021 at 09:40 (at the age of 82 year) as SINGLE DOSE for covid-19 immunisation. The patient medical history reported as none and relevant tests reported as none. Concomitant medication(s) included paracetamol (TYLENOL) taken for an unspecified indication from 01Feb2021 to 04Feb2021. Patient was not received any other vaccine prior four weeks of vaccination. Patient received second dose on 22Feb2021 at 9:40 AM (batch no: EN5318) for COVID-19 immunisation at Hospital and experienced fatigue and neck pain. In 2021 the patient experienced fatigue and mild stomach issue for 3 days. She explains that on Monday she got her first dose. Today she was talking with some and it was mentioned that she had gotten a steroids injection the Friday before the shot was given and that might not have been a good idea. Caller would like to know if we have any information regarding this. It was administered on 10Feb2021, but the lot was left blank. It was explained the steroid shot was before getting the vaccine. Therapeutic measures were not taken as a result of the events. The outcome of the events fatigue and mild stomach issue was recovered in 2021. No follow-up attempts are possible. No further information is expected.

Admitted to hospital testing positive for COVID after being fully vaccinated. Patient admitted 05/29/21 with a GI bleed, patient asymptomatic for COVID s/s but was tested following hospital admission policies and had a positive PCR test on 05/29/2021. Patient reports her husband was positive for COVID a few weeks prior. Patient treated for GI bleed and d/c'd home on 05/30/2021. She returned to the hospital same day within a few hours reporting dizziness, syncopal episode, and slurred speech per medic. Admitted again with a-fib with RVR. No fever or cough, did report some shortness of breath at home. Discharged on 06/04/21, then readmitted for a-fib with RVR again, discharged home with homecare on 06/14/21.

Chills; fever; severe fatigue; headache; nausea; joint pain; trouble breathing; One week very sick; Was bed ridden since 01Mar2021; This is a spontaneous report from a contactable consumer (Patient). A 83-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: E L3302) via an unspecified route of administration in left arm on 01Mar2021 at 00:00 (age at vaccination 83-year-old) at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, heart disease, cancer survivor, fibromyalgia and high blood pressure. Patient had known allergies. The patients concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021, at 00:00 patient experienced chills, fever, severe fatigue, headache, nausea, joint pain and trouble breathing. Patient was bedridden since 01Mar2021 the day of the shot and was very sick for one week. Therapeutic measures were taken as a result of chills, fever, severe fatigue, headache, nausea, joint pain, trouble breathing, one week very sick, was bed ridden since 01Mar2021. The outcome of event was recovering at the time of reporting. No follow-up attempts are possible. No further information is expected.

She had more severe diarrhea; This is a spontaneous report from a contactable consumer. A an 82-year-old female patient (reporter's mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: E29269, NDC number and Expiry Date: Unknown) dose 1 via an unspecified route of administration, administered in the Upper Left Arm on 18Feb2021 (at the age of 82 years old) as a DOSE 1, SINGLE for covid-19 immunisation (it is her best hope for not catching Covid). Patient's medical history included diabetes mellitus from an unknown date and unknown if ongoing Diagnosis date, Reporter stated, "Late 90s, I don't know", hypothyroidism from 1985 to an unknown date, glaucoma from 1988 to an unknown date. Patient also had atrial fibrillation, cardiovascular disorder, urinary incontinence and blood cholesterol abnormal, all from an unknown date and unknown if ongoing. For Other Conditions Diagnosis date was stated by Reporter as, May be 2011 (unspecified).Concomitant medications included insulin lispro (HUMALOG) taken for diabetes mellitus, 6 Units, three times a day before each meal, insulin glargine (LANTUS) taken for diabetes mellitus 8 Units at bed time, atenolol taken for cardiovascular disorder, 50 mg twice a day, dabigatran etexilate mesilate (PRADAXA) taken for atrial fibrillation, 150 mg, twice a day, hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, 25 mg, once every other day, losartan taken for an unspecified indication, 100 mg once a day, levothyroxine sodium (SYNTHROID) taken for hypothyroidism, One day 50 mcg and other day 75 mcg, simvastatin taken for blood cholesterol abnormal, 10 mg, once a day, metformin hydrochloride (METFORMIN ER) taken for diabetes mellitus, 500 mg, once a day, brimonidine tartrate, brinzolamide (SIMBRINZA) taken for an unspecified indication, Twice a day and travoprost taken for an unspecified indication, Once a day. All concomitant medications were started on an unspecified date and unknown if was ongoing. The patient experienced she had more severe diarrhea on an unspecified date. She had more severe diarrhea was reported as worsened. Patient had the Pfizer Covid vaccine on the 18Feb that was her first one and she has had problems like diarrhea and her gastro tract (Incomplete sentence). She pretty much had it on and off. Today (date unspecified) she has had more severe diarrhea than before in those days before. She was wondering if that could be attributed to the Covid vaccine." Patient took an antidiarrheal after the last one in the afternoon (date unknown). This was an over the counter, it is called Loperamide HCL soft gelatin capsule, 2 mg and she took 2 of them but they are expired, the expiration date was Jul2020. That all the patient had at home. Outcome of the event was Not Resolved. No follow-up attempts are possible. No further information is expected.

Heart attack; Arterial occlusion/artery was blocked; Fluid loss; Acute haemorrhagic ulcerative colitis; Diarrhea; Bowel obstruction; Hemorrhoids; Postoperative pain; Groin hernia; Lower extremity mass/big lump on her groin; This is a solicited report based on the information received by Pfizer from manufacturer control number: 21K-163-3910536-00). A contactable consumer (patient) reported that an 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in Feb2021 (Batch/Lot number was not reported), at the age of 82-year-old, as single dose for covid-19 immunisation; adalimumab (HUMIRA), via subcutaneous from 2011 (Batch/Lot number was not reported) and ongoing, at 40 mg (1 in 2 wk) (40MG/0.4ML) for rheumatoid arthritis and ulcerative colitis. Medical history included ulcerative colitis, control unspecified blood condition and heart issues. Concomitant medications included sulfasalazine taken for colitis ulcerative, start and stop date were not reported; prednisone taken for colitis ulcerative, start and stop date were not reported; folic acid taken for control unspecified blood condition, start and stop date were not reported; atorvastatin calcium (LIPITOR) taken for heart issues, start and stop date were not reported; isosorbide taken for heart issues, start and stop date were not reported; losartan potassium (COZAAR) taken for heart issues, start and stop date were not reported; metoprolol taken for heart issues, start and stop date were not reported. The patient previously took the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 81-year-old, in Jan2021 for covid-19 immunization. The patient experienced heart attack on 19Apr2021, groin hernia in Mar2021, lower extremity mass in Mar2021, acute haemorrhagic ulcerative colitis on 13Apr2021, diarrhea on 13Apr2021, bowel obstruction on Apr2021, fluid loss on 13Apr2021, arterial occlusion on 19Apr2021, hemorrhoids in Apr2021, postoperative pain in Apr2021. The patient hospitalized from 18Apr2021 to 25Apr2021 due to these events. It was reported that the patient with events of heart attack, groin hernia, big lump on groin, bleeding a lot as a complication of ulcerative colitis, diarrhea, blockage in bowels, loss of fluids and artery was blocked and non-serious possible hemorrhoids and postoperative pain with Humira 40mg/0.4ml (Adalimumab). In Mar2021, the patient experienced groin hernia and big lump on groin. In Apr2021, the patient experienced blockage in bowels, possible hemorrhoids and postoperative pain. On 13Apr2021, the patient experienced bleeding a lot as a complication of ulcerative colitis, diarrhea and loss of fluids. On 19Apr2021, the patient experienced heart attack and artery was blocked. On 19Apr2021, the heart attack and artery was blocked resolved. On 20Apr2021, the diarrhea resolved. On 25Apr2021, the bleeding a lot as a complication of ulcerative colitis resolved. In Apr2021, the groin hernia, big lump on groin, blockage in bowels, loss of fluids, possible hemorrhoids and postoperative pain resolved. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. Unknown stool softener also considered as suspect. In Mar2021, patient felt a big lump on her groin that was determined by physician as a hernia through physical examination and not an imaging test. On 09Apr2021 she had an outpatient surgery due to hernia in her groin. When she took acetaminophen as prescribed she had a blockage in her bowels and took unspecified stool softener which caused terrible diarrhea. On 16Apr2021 she went to the emergency room due to the diarrhea and had loss of fluids and just went home even when advised not to go home. On 18Apr2021 she was continued having diarrhea, she went back to the emergency room and had unspecified blood test that confirmed she was having a heart attack while on emergency room due to not taking her medications for the heart because was told not to take any medication while having diarrhea which she also temporarily interrupted her Humira while having diarrhea. Physician advised to admit patient to the hospital as she was told she was having a heart attack. On 19Apr2021, she had another stent because the artery was blocked from her previous stent. On 25Apr2021 she was discharged. She believed that her hospitalization was prolonged to nine days (as reported) due to she was bleeding a lot as a complication of ulcerative Colitis. She had a shot of covid 19 vaccine before at least one symptom happened therefore covid 19 vaccine was considered as co suspect product. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On Jan2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. On Feb2021, patient received second dose COVID-19 vaccine manufactured by Pfizer. The patient was treated with acetaminophen. The patient underwent other lab tests and procedures which included blood test: heart attack on 18Apr2021, laboratory test with unknown results in 2021. The action taken in response to the events for adalimumab was unknown. The outcome of the events heart attack, Arterial occlusion/artery was blocked, Postoperative pain was recovered on 19Apr2021. The outcome of the event groin hernia, Lower extremity mass/big lump on her groin, Bowel obstruction, Fluid loss, Hemorrhoids was recovered in Apr2021; of the event Acute haemorrhagic ulcerative colitis was recovered on 25Apr2021; of the event Diarrhea was recovered on 20Apr2021. The reporter's causality for the events of heart attack, groin hernia, big lump on groin, bleeding a lot as a complication of ulcerative colitis, diarrhea, blockage in bowels, loss of fluids, artery was blocked, possible hemorrhoids and post operative pain with humira 40mg/0.4ml (adalimumab) was no reasonable possibility. The reporter's assessment of the causal relationship of the events with the BNT162B2 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. Manufacturer opinion is that there is no reasonable possibility that the events of heart attack, groin hernia, big lump on groin, bleeding a lot as a complication of ulcerative colitis, diarrhea, blockage in bowels, loss of fluids, artery was blocked, possible hemorrhoids and post operative pain are related to humira 40mg/0.4ml(adalimumab). No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Blurred eyes; Weak; Blood pressure and heart rate off the wall; Blood pressure and heart rate off the wall; Swelling of the face; Mouth was swollen, just her face and her lips were real swollen; Mouth was swollen, just her face and her lips were real swollen; Tiredness; Had a bowel movement, it was white-looking and smelled like a chemical; Urinating cloudy and with a chemical smell; her eyes were so foggy; Running from nose; Coughing; Having trouble thinking; This is a spontaneous report received from a contactable consumer or other non hcp. A 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported; Expiration Date: Feb2022) via an unspecified route of administration in Arm Right on 05Mar2021 13:20 (age at vaccination 82years old) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure measurement. The patient's concomitant medications were not reported. The patient experienced running from nose, coughing, her eyes were so foggy, urinating cloudy and with a chemical smell on 05Mar2021, blood pressure and heart rate off the wall, swelling of the face, mouth was swollen, just her face and her lips were real swollen, weak, tiredness, had a bowel movement, it was white-looking and smelled like a chemical on 06Mar2021, having trouble thinking on Mar2021, blurred eyes on an unspecified date. She has never reported the side effects that she had, and her daughter told her should have done that. She found her papers and now she is 82 and she got her first shot on 05Mar2021. Patient reported as she felt fine then she got up to leave and her nose started running and it was just like water was pouring out and she made it up to the front and had Kleenexes in her pocket, then started coughing violently, her nose was running violently and trying to come out of her mouth, and she sat down on the chair there and she thought it will pass. she walked out to look for the person that took her out there and she saw exactly where they parked, and her eyes were so foggy she could hardly even see the car. She felt okay then the next day, she got up and her mouth was swollen, just her face and her lips were real swollen. However, her whole face was swollen. she didn't read the side effects to it and thought oh well, it's just some-thing. The next day her blood pressure was going off the wall, her heart rate was horrible, she called the doctor, they wanted her to go to the hospital. The doctor told her to take Benadryl, and Benadryl bothers her, and she said that made her worse. It made her worse. She further clarified made her worse as, it made her heart worse, dizzy and lethargic and she was already tired anyway. she would have been better off not taking it. Her heart rate, which is always normal or very good, and it was like it was going ninety miles an hour. she would get it to slow down then it would feel like it was going 90 miles an hour for a few days then she was really weak and her mind, which at her age she has a very good mind, they tested that, she was having trouble thinking. she guesses she would call it foggy. she wanted to sit down and pay bills, but she couldn't even concentrate. Her question is she had the first shot but now she's afraid to get the second shot because of what it did the first time around. she's afraid it will do double; they say it's a worse reaction. The card that she had, she said that her nose was running so bad, she shoved the card in her purse and looked in her purse later and she can't even find that card. She will say she can't get the flu shot because in the past, she had a very bad reaction from the flu shot, she was questioning whether to get this vaccine or not. It wasn't a live vaccine. she is scared to death of the virus and her kids wanted her to get it now, hurry, hurry, and she thought she would try it. Since she has reactions to suspect product, she's concerned about getting the second one. That was 10 years or more that she had the bad reaction. She is a person that her body is very sensitive. Her doctor has trouble getting medicines she can take. She has a bad back, she has tired every painkiller there is and she can't take any of them, they are worse than the pain. She has trouble seeing too. She keeps every-thing up, they don't give as many papers and it changes every week. She doesn't know how the people in the medical profession can take it, she imagines they change things on them overnight. She has macular. She couldn't understand with that shot why she could see whenever she went in and after she got the shot then everything was fogged when she came outside, but she knows it still wasn't as bad as getting the virus. She's still weak, but she's gotten better. They said she could leave, her nose started running and she started coughing. The girl said is she okay and thought she was, and she made it out then started coughing violently and that water was almost drowning her. She sat down in the chair, and it finally calmed down and got in the car, kept wiping that water with paper towels in her car and coughing and by the time she got home it was slowed down. She is more tired than usual, and her eyes haven't cleared up as good as they should. She doesn't know what that happened, it just came out of there and thought well god what has happened to her eyes. She has an appointment with the Optometrist at the end of April. Another thing she forgot, they are going to think she's looney, she started urinating that evening and she thought, this is not good, something was going on with her kidneys, because it was cloudy-like and had a chemical smell and then the next morning, she still smelled the same thing and her bowels were the same way, just smelled this chemical. That evening her urine was like that and the next morning she noticed it was like that into the next day, whatever was in there had to come out and then her urine and things cleared up. Started on 05Mar2021, that evening, when she urinated before she went to bed it was cloudy and had this chemical smell, maybe it was something she ate or something. The next morning, she urinated a lot and it was cloudy and the bowel movement, it was white-looking and smelled like the chemical and cleared up. She has recovered completely after whatever was in there got out the next day. She states she was okay after she did all that, she cleared up. The clinical outcome of the event blurred eyes was unknown, another events week, her eyes were so foggy, having trouble thinking, tiredness was recovering, and event running from nose, coughing recovered on 05Mar2021, blood pressure and heart rate off the wall was recovered on 09Mar2021, swelling of the face, mouth was swollen, just her face and her lips were real swollen was recovered on an unspecified date Mar2021, urinating cloudy and with a chemical smell and had a bowel movement, it was white-looking and smelled like a chemical was recovered on 06Mar2021. Therapeutic measures were taken as a result of swelling of the face (swelling face), mouth was swollen, just her face and her lips were real swollen (mouth swelling), mouth was swollen, just her face and her lips were real swollen (lip swelling). Information on Lot/Batch number was available. Additional information has been requested. Follow-up (05Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Nausea, diarrhea began morning after 2nd Pfizer shot on February 25,2021 Today's date is July 22,2021 (5 months of symptoms)

all over prickly skin; sweating all over; low pulse; feeling cold; vomiting; Diarrhea; feeling very weak.; This is a spontaneous report from a contactable consumer, the patient. A 82-year-old female non-pregnant patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 31Mar2021 at 12:30 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. Medical history included cardiovascular disease and thyroid. The patient received unspecified medication within two weeks of vaccination. The patient previously took PLAVAX on unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 21:00 the patient experienced all over prickly skin, sweating all over, low pulse, feeling cold, vomiting, diarrhea and feeling very weak. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event all over prickly skin, sweating all over, low pulse, feeling cold, vomiting, diarrhea and feeling very weak was recovering. No follow-up attempts are needed. No further information is expected.

On phone follow-up after vaccine patient noted that she fainted and vomited ~1.5 days after vaccine. Event occurred in the public. EMS was called but patient declined transport to ER facility. Patient said she felt fine after event and no further issues after episode. Patient has had no further follow-up with another health care provider for event.

Patient on phone call follow-up noted that she fainted and vomited about ~1.5 days after vaccine administration. Patient was in a public area and EMS was called. Patient noted she felt fine after event and refused transport to another facility. No other issues noted after this episode per patient.

83yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, the patient reportedly got up in the middle of the night with c/o feeling "blah", restlessness, and nausea. VS normal, no other s/sx. At 4:15am, the patient was asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient unresponsive, no pulse, no respirations. GNA notified the nurse. At 6:03am, CPR started and EMS called. At 6:15am, EMS arrived and took over. At or around 6:30am, EMT called time of death

At approximately 11:09 am, patient began complaining of dizziness, headache, blurry vision and nausea. Patient states that she had a headache on arrival and took her bp meds this morning. Patient released by EMS to home with friend on site.

Patient within 10 minutes experienced nausea, lightheadedness, and dizziness. Patient went to ED. received hydration and ondansetron 4 mg. Discharged from ED.

Resident complain of not feeling well. Upon entering her room, she was jittering, witnessed some uncontrollable movement nausea and vomited once. she called her son and said that she had the second covid shot yesterday and since then she is not feeling well. VS stable, no fever, MD called, resident currently in bed alert and oriented x 3, no change in mental status.

swollen lips; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; chills and shaking; chills and shaking; red dot on the inside of her throat; she took the Benadryl thinking it was an allergic reaction; swelling on left side where the nodule was removed; burning sensation in her left arm; ear pain; nausea; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on Left deltoid (upper left arm) on 13Jan2021 14:00 at single dose to prevent COVID. Medical history included sulfa drug reaction, high blood pressure diagnosed in 1970s or 1980s (States she was in the hospital in the 70s or 80s. She has high blood pressure which has been difficult to control, she is seeing a cardiologist and he is content with her blood pressure readings, her diastolic is normal), incontinence, thyroid nodule surgery a year ago (2020), thyroid nodule, ten operations in the last 3 years, tightening in her neck repeatedly since her thyroid nodule surgery, scratchy throat problems since a week prior to getting the vaccine (from Jan2021) and post nasal drip and she has had that for years and when they operated nothing worked. The patient's concomitant medications were not reported. The patient previously took cipro where she could not breathe. She does not have lot, ndc or expiration date to provide for any of the medications mentioned that she had a reaction to. She took the Asiatic flu shot in 1958 (as reported), she had a reaction and high fever, weak and pale. This occurred when she was 19 years old. She took the Pfizer covid 19 shot last Wednesday. She stated that it could be her but she got a few of the reported side effects. What she found most important was that she had swollen lips that started about an hour after receiving the vaccine. Last night (13Jan2021) she got the chills and was shaking during the night. She had mild chills in the last few days, during the night she was shaking from the chills but it may have been cold at night, reporting the chills have subsided but she can feel it a little bit. In Jan2021, she felt a burning sensation in her left arm which lasted about two minutes. She got a piercing earache in her left ear for about two minutes and then it went away. She experienced nausea within two minutes, but she ate the ginger candy she had in her purse and her nausea went away. She could have something else too since she has a red dot on the inside of her throat. She did not see it was red before last night (13Jan2021). She took Benadryl on Wednesday afternoon after she called the doctor's office, she took the Benadryl thinking it was an allergic reaction, her swollen lips seemed like it was improved but now it was minor. She has had the tightening in her neck repeatedly since her thyroid nodule surgery but she felt the tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening, it is sort of still ongoing but states it has sort of improved. Patient also mentioned swelling on left side where the nodule was removed. She was asking if she should get the second dose. She has an appointment for her second dose. She has never had much problems till she was 80. Her husband tested negative for covid and she tested negative in Aug2020 prior to one of her surgeries. Patient stated that she is 83 but she is biologically younger. She felt pretty good normally. The events did not require emergency room visit or physician office visit. No prior vaccinations (within 4 weeks). The outcome of the events burning sensation in her left arm, ear pain and nausea was recovered in Jan2021; Swollen lips, tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening, chills was recovering; and unknown for the other events. Information about batch/lot number has been requested.

Vaccine administered to pt at 1805. Pt observed for 30 minutes due to history of allergies. AT 1835 pt reported feeling "cold, nauseous" and reported feeling "every side effect on the handout." Staff provided juice and graham cracker and assessed vitals. Vitals within patient's baseline. Pt then reported "back pain" and described ita s "squeezing" Staff performed 12 lead EKG. EKG results within patient's baseline. Pt kept for another 10 mins and observed. Staff advised pt to contact doctor and go to ER if symptoms persist. Pt reported feeling better and comfortable with going home. Pt went home after a total of 45 minutes of observation with daughter.

5 cold sores, red blotch on cheek, fever, fatigued, gastro distress, Woke up the next day, 1/23/21 with these events. All was gone the next day except the cold sores which are now healed.

Began with vomiting and diarrhea. C/O chest pain. Bradycardia. Hypotension. 2 seizures in 45 minutes after not having one in years. We gave fluids. Gave Zofran. Comfort measures. Pt passed at midnight. Was completely fine one day before. Had minimal issues with COVID though did have a pneumonia that was treated w ATB early on and resolved.