Pfizer

Sore and tender right arm, chills, muscle ache, joint pain, some nausea, fatigue starting at about 6 PM EST on 1/13/21, worse on 1/14/21 until around 5 PM EST, better on 1/15/21 with some fatigue, but all symptoms recurring again that evening starting around 7 PM EST. I took Tylenol 325 mg around 10 PM EST and went to bed and feel normal so far today 1/16/21.

Narrative: Was pt previously covid positive?- Yes. Initial- 10/27/2020, 11/29/2020, 12/22/2020 Are there any predisposing factors for patient experiencing adverse drug event?- Yes, patient had multiple co-morbidities including GI bleed, hepatitis congestion due to cardiac issues, treatment for PE, NSTEMI, or antibiotics for PNA, also on concurrent medications APAP, Atorvastatin, Mirtazapine and Duloxetine. Pt with 2 doses of covid-19 vaccine, second one on 01/08/2021, 2 days pre-death Any occurrence of an ADR at time of administration? Did not specify injection site issues, per RN admin note- Vaccine "administered without complications." Did patient recover from event? Not s/p dose on 01/08/2021. First dose given on 12/21/2021, LFTS increased ~01/01/2021, peaked on 01/03/2021 and were decreasing on 01/07/2021 Was there an ADR between observation period and date of death? No Did patient recover from event? No (01/08/2021 event, died 01/10/2021) Was patient hospitalized prior to vaccination? Yes, in between inpatient and nursing home Was patient hospitalized prior to death--was hospitalization attributable to ADE? Yes re-admitted to inpatient on 12/31/2020. GI bleed Is there an alternative cause of death? Yes, as noted above. Quite a complicated case with many comorbidities/concurrent medications as noted above. Primary Diagnosis: Upper GI Bleed in the death note from 01/10/2021

fever; tiredness; muscle pain; chills/shaking in bed with blanket on; still get wet/sweat; headache; nausea; feeling unwell; Felt "very sick"; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on 06Jan2021, at 76 years of age, at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 06Jan2021, 45 minutes after shot, the patient felt "very sick" and was on bed for 4 days; moreover the patient reported he had "a big reaction" as, on an unspecified date, he felt fever, tiredness, muscle pain, chills (reported as "shaking in bed with blanket on"), still get wet/sweat, headache, nausea and feeling unwell. All the reported events were assessed as non-serious. At the time of the report the events "felt very sick", "tiredness", "muscle pain", "chills/shaking in bed with blanket on" and "still get wet/sweat" had resolved on an unspecified date, the events "fever", "headache" had not resolved yet and outcome of the events "nausea" and "feeling unwell" was unknown. The patient asked whether or not to take the 2nd shot in 3 weeks. Information on the lot/batch number has been requested.

He is also experiencing coughing; all I wanna do is sleep; Had aches and pains; He also has joint pain and pain in his right arm, hand, and wrist area; He also has joint pain and pain in his right arm, hand, and wrist area; Diarrhea; He is also very fatigued and does not want to get out of bed and that he is so tired; off and on headaches; This is a spontaneous report from contactable consumers. A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176), intramuscular on 06Jan2021 11:28 (also reported as about 1130) at a single dose on left arm for COVID-19 immunization. Medical history included pulmonary fibrosis from 2014 and ongoing, ongoing type 2 diabetes mellitus (Diagnosed probably in 1996-1997; under control). The patient previously had pneumonia shot in 2020 and flu shot in 2020 (few months ago in Oct2020/Nov2020) both for immunization. The patient's concomitant medications were not reported. The patient experienced diarrhea, very fatigued and does not want to get out of bed and that he is so tired, and off and on headaches, all on 07Jan2021. He also has joint pain and pain in his right arm, hand, and wrist area on 11Jan2021. He experienced coughing, somnolence, and had aches and pains on an unspecified date. Patient received the vaccine last Wednesday. He experienced diarrhea (on Thursday and Friday, went away then came back on Yesterday), had aches and pains, and severe fatigue (all I wanna do is sleep). Today he said that he wasn't having diarrhea that can be attributed to him not eating much yet, a few aches and pains, very tired, and a minor headache. He was asking how long do these symptoms usually last. Patient received it last Wednesday 06Jan2021 at about 1130. He said that he has been experiencing side effects, not severe, but on Thursday 07Jan2021 and Friday 08Jan2021, he had diarrhea. He said that on Saturday 09Jan2021 the diarrhea let up and Sunday 10Jan2021 was ok, but yesterday 11Jan2021 the diarrhea was bad. He said that he is also very fatigued ("severe fatigue (all I wanna do is sleep)") on 07Jan2021 and does not want to get out of bed and that he is so tired. He has had no fever, but has had off and on headaches. He said that he also has joint pain and pain in his right arm, hand, and wrist area. He said that it is hard to pick up a cup or glass because of the pain. He said that he got the injection in the left arm. He said that he is also experiencing coughing, but stated that he does have pulmonary fibrosis and it could be that. Diarrhea: patient said that his diarrhea is improved as of today 12Jan2021. Fatigued: he said that he noticed it on 07Jan2021, it subsided Saturday 09Jan2021 and Sunday 10Jan2021, but yesterday and today 12Jan2021 it is very prominent and he is very tired. Headaches: He said that the headaches are not severe, but they were there. He said that the headaches are not there today. Pain in the arm, hand, and wrist area: He said that he noticed the pain yesterday and stated that it is slightly worse. Coughing: He said that he coughs due to the pulmonary fibrosis too and sometimes it is a lot and sometimes it is a little bit. He said that he has to get his second dose on 27Jan2021 at 1500. He stated that his brother died of Covid last Thursday. The outcome of event diarrhea was recovering, of "he is also very fatigued and does not want to get out of bed and that he is so tired", "he also has joint pain and pain in his right arm, hand, and wrist area", and "coughing" was not recovered, of "off and on headaches" was recovered on 11Jan2021, of the events "all i wanna do is sleep" and "had aches and pains" was unknown. No relevant tests. No prior vaccinations within 4 weeks. No family medical history relevant to AE.

1st dose of vaccine was 1/12/21, Lot number EK9231 2nd dose 2/2/21, Lot number EL8982 Patient was feeling well the day of vaccine and reports no recent illness, no adverse events to first injection in COVID vaccine series. 20 minutes later developed dizziness and nausea. Within hours noticed LUE weakness. Weakness has progressed over last two days to severe left upper extremity and left lower extremity weakness with inability to walk. No sensory deficits. Some urinary retention. Hyperreflexia on examination with upgoing toe on left. Presentation consistent with transverse myelitis. Patient remains hospitalized at this time, starting treatment with IV solumedrol for clinical transverse myelitis. Workup remains in process

Severe headache, body aches, slight nausea,, complete fatigue unable to function, chills, fever101.6 (highest) total feeling of unwell

soreness on left shoulder; stomach spasm; vertigo; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of BNT162B2 (lot number: ek4176), via an unspecified route of administration in left arm on 12Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included glaucoma, gastrooesophageal reflux disease (GERD), benign prostatic hyperplasia (Bhp), and cholesterol. Concomitant medications included tamsulosin, metoprolol, and travoprost. Patient experienced soreness on left shoulder, stomach spasm and vertigo started on day 4 of vaccine on 15Jan2021 21:30. Patient went to hospital ER on tenth day after vaccine and released from hospital ER after 2.5 hours. AE result in: Emergency room/department or urgent care. Treatment was not received for these events. Outcome of the events was resolving.

profuse vomiting, no nausea/had a huge episode of vomiting; felt really tired/felt tired; sleeping; This is a spontaneous report from a contactable nurse. A 76-year-old male patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EL3302, expiration date: 31May2021), via an unspecified route of administration on 21Jan2021 at 11:00 at single dose on left arm for gain immunity against Covid-19. Medical history included stroke from 2017. There were no concomitant medications. Caller was reporting on her husband. He received the first dose of the Covid-19 vaccine yesterday (21Jan2021). He felt tired today (22Jan2021). 24 hours after he received the vaccine, he had a huge episode of vomiting. He was not nauseated and didn't even feel sick. He ate this morning as usual. All of a sudden he vomited. He still did not feel nauseated. He was tired on 22Jan2021 and was sleeping in Jan2021. Reporter had not measured his temperature but said he did not have a fever. He hadn't vomited in years. Outcome of the events was unknown. This case was reported as non-serious.

Mild nausea; Mild fatigue; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249) via unspecified route of administration at left arm on 14Jan2021 at 08:00 AM at single dose for COVID-19 immunization. Medical history was not provided. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included simvastatin (within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2. The patient experienced mild nausea and mild fatigue 6 hours after injection, at 02:00 PM on 14Jan2021. Duration for one week (6 days 10 hours). The events were reported as non-serious. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive treatment for the adverse events. Outcome of the events was recovered on 21Jan2021.

on 1/25 patient experienced dizziness, nausea and vomiting, dizziness worsened the next day. Nausea improved within a day and dizziness resolved fully in one week. According to records reviewed "LINQ device and showed mild arrhythmia but no Afib" MRI brain 1/26/2021: Tiny acute lacunar infarct in the left posterior medulla.

Had major nausea beginning 4 days after vaccination. Then was tested positive for COVID 12 Days after Vaccination on 02/02/2020. Confirmed with Rapid test, Confirmed with PCR Test. Patient was 1 of 4 in a small group of elderly relatives who got vaccinated that day. 2 individuals received Moderna, 2 received Pfizer vaccine. His wife then also tested positive for COVID 1 week later. The Moderna Couple never tested positive for COVID. ( 3 Tests over 2 weeks. ) All 4 had practiced strong COVID preventative measures and did not ever let their guard down. Face Mask, Constant Hand Sanitizing, Washing, No Crowds. He started to worsen and was given Bamlanivimab infusion on 02/08/2020 which had an immediate positive affect. By end of 02/12/2020 he appears to have almost completely recovered.

very bad abdomen pain and back kidney area pain chills and weakness for 24 hours and still four days later very week and unable to do much activity

Following day after vac. resident had increased lethargy, nausea, altered mental stats, temp 100.1 bp 96./52, hr 107. Sent to er 1/29, returned 1/31 diagnosis systemic inflammatory response syndrome. On 2/1 resident had temp and respiratory distress. Sent to er again. Returned 2/3 with diagnosis CHF. On 2/7 resident sent out again after stat labs and xray. xray showed infiltrates. Returned from er on 2/10 diagnosis acute encephalopathy and metabolic encephalopathy.

dizzy; nauseous; left arm weakness/left leg weakness; numbness and tingling of his left fingers; numbness and tingling of his left fingers; lost balance; fell; This is a spontaneous report from a contactable physician. A 76-year-old male patient received 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: 59267-1000-1) intramuscular at left arm on 02Feb2021 at 11:00AM at a single dose for COVID-19 immunization. Medical history included closed fracture of patella, coronary atherosclerosis, essential hypertension, malignant neoplasm of prostate, and known allergies: acetominophen, doxycycline, oxycodone-acetominophen, oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: 59267-1000-1) intramuscularly at left arm on 12Jan2021 at 12:00PM for COVID-19 immunization. Other medications in two weeks included omeprazole (PRILOSEC, strength: 20 mg), CPD losartan potassium (COZAAR, 25 mg, tablet), simvastatin (strength: 20 mg, tabs), hydrochlorothiazide (strength: 25 mg, tabs). No other vaccine in four weeks. Facility type vaccine was at Doctor's office/urgent care. Adverse events were reported as follows: 20min after getting the 2nd dose, the patient became dizzy and nauseous. 20 min after that the patient developed left arm weakness and numbness and tingling of his left fingers. When trying to get out of his car, he lost balance and fell. He had no loss of consciousness or head trauma. He had progressively worsening left arm and left leg weakness. Adverse event start date was reported on 02Feb2021 at 11:30AM. AE resulted in Emergency room/department or urgent care, hospitalization for 3 days. Treatment received for AE included baclofen and methylprednisolone. The outcome of events was not recovered. No covid prior vaccination. Covid tested post vaccination included Nasal Swab (NAAT) on 02Feb2021 was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

RECEIVED 1ST DOSE OF PFIZER COVID VACCINE ON 02/14/21. ON 02/20/21 REPORTED ED FOR GENERALIZED WEAKNESS, FATIGUE. , AND NAUSEA/VOMITING/DIARRHEA AND BEING UNABLE TO EAT SINCE YESTERDAY. ON 02/20/21 ADMITTED INPATIENT TO HOSPITAL WITH DIAGNOSIS OF ELEVATED TROPONIN AND GENERALIZED WEAKNESS.

Fever; belly is swollen; hurting; hard for him to breath/moves and exerts, his breathing is labored; extremely tired; muscle pain, aches; extreme chills/shivering; shaking; Joint pain; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EL3248, expiry date not reported), via an unspecified route of administration on 02Feb2021 11:00 at a single dose in the left arm for COVID-19 immunization. Medical history included ongoing atrial fibrillation (reported he has had no occurrence for 3-4 years); and high blood pressure and high cholesterol, both from an unknown date and unknown if ongoing; and pneumonia. Concomitant medications included that patient was also taking high blood pressure medication and high cholesterol medication. When asking for the Lot number, reporter explained "his card was in his wallet but she gave her lot and said it was the same, they got the shot at the same time, within 5 minutes of each other". Patient previously took amoxicillin for pneumonia from 09Jan2021 to 13Jan2021, reported as he took this for 5 days and stopped. This was reported as "It was noted that he had pneumonia and got an antibiotic that he took for 5 days. It was amoxicillin and was started on 09Jan2021" (pending clarification). Reporter also stated that she was not sure if it was a Pfizer vaccine but patient did have a mild reaction to the first shingles vaccine (unspecified) but this lasted only 24 hours. Reporter, a wife calling for her husband (patient), was reporting on the COVID vaccine and who explained he was having symptoms and wanted to report this but also has a question on what to do. Patient was extremely tired. This was noticed on the 3rd day after the shot. This would be Friday 05Feb2021 and it was the same since starting. There were moments when he has rested and showered where he felt better but then it went down again. The patient had muscle pain, aches on 05Feb2021, this would be Friday, and it came and went but was about the same. Patient had extreme chills on 05Feb2021, and he was still shaking now (05Feb2021). It was a little better during the day, maybe because he was moving around but last night he was shivering and shaking for 3 hours and she could not get him warm even with the heating pad. Patient also had joint pain on 05Feb2021 and it was the same since starting. Patient had fever that probably started Sunday, 07Feb2021 wherein few hours ago, it was 102.00 but she got it down to about 100.2 now, it has increased and was the reason she called today. Patient's belly was swollen since 05Feb2021 and it was the same since starting. She remarked she was not sure if this was where lymph nodes were or not and the cause of the swelling. It was also explained that due to hurting, it was hard for him to breath. When he moved and exerted, his breathing was labored. This would be Friday, 05Feb2021 and it is the same since starting. Yesterday, patient went to his primary doctor. He was supposed to do blood work but couldn't due to his fever. The doctor prescribed him an anti-inflammatory called Etodolac 500mg. It was by Taro Pharmacutal US (there was no Lot or expiry). He took one at 7pm and was to take them twice a day, took another a little while ago. Reporter explained she has heard stories where the second dose is worse, and wanted to know if that is true. She also wanted to know if the product Etodolac, has side effects that are similar to what patient was experiencing, and wouldn't taking that make the side effects double worse. Therapeutic measures were taken as a result of the events extreme chills/shivering, shaking, joint pain, and fever. The events extremely tired, muscle pain, aches, extreme chills, shaking, joint pain, fever, belly was swollen, hurting, and "hard for him to breath/moved and exerted, his breathing was labored" were not recovered

Fever, chills, diarrhea, nausea. I just let it run its course, no treatment, lasted approx 6 to 8 hous.

Weak clogged up, my hands were numb and chills, fever, nausea, feeling unwell, my nose feels swollen, runny nose, my lymphoids are swollen, im tired. Joint pain, and just drowsy, slight headache at time. Slight case of constipation

Chills; Headache; extremely weak; has not felt like eating anything; This is a spontaneous report from a contactable nurse reporting for her husband. A 76-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL9264), via an unspecified route of administration in the deltoid right, on 03Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history included cardiac disorder from 2007 and ongoing, cholecystectomy on 21Dec2020, stent placement from Dec2020 to Jan2021 (stents placed on 27Dec2020 or 28Dec2020, in Jan2021 it was removed), hospitalisation from Dec2020 to Jan2021 (for 11 days), ongoing weakness (weakened state). The reporter explained that her husband had some big issues from Nov2020 to Jan2021 which ended in the removal of a dead gallbladder that was gangrene and had to have stents placed. He was in a weakened state already. There were no concomitant medications. No other vaccines were administered on the same date or 4 weeks prior. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1283) on 13Jan2021, for COVID-19 immunisation, with no adverse effect. The patient experienced chills on 08Feb2021 with outcome of not recovered, headache on 08Feb2021 with outcome of not recovered, extremely weak on 08Feb2021 with outcome of not recovered, has not felt like eating anything in Feb2021 with outcome of not recovered. The events chills, headache and extremely weak were considered medically significant. Therapeutic measures were taken as a result of chills and included treatment with Tylenol. The reporter assessed the events as related to vaccination.

Bell's Palsy/drooping of his face and mouth; Bloody nose; vertigo (dizzy / lightheaded); vertigo (dizzy / lightheaded); swallowing issues; Chewing issues; weak; tired / does not have stamina; This is a spontaneous report from a contactable consumer (the patient's wife). A 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9264), via an unspecified route of administration in the right arm on 09Feb2021 at 12:30 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included vertigo (before the 2nd dose all the time), diabetic type 2 due to exposure to Agent Orange, stent in Dec2019, sulfa allergies, blood pressure abnormal. Concomitant medications included metformin, buspirone, sitagliptin phosphate (JANUVIA), hyoscyamine sulfate (OSCIMIN), doxepin, lisinopril for blood pressure, silodosin, simvastatin (ZOCOR), exenatide (BYDUREON) for diabetes, fish oil, zinc tablet in the morning, ubidecarenone (COQ-10), vitamin D3, cyanocobalamin (VIT B12), allium sativum bulb (GARLIC EXTRACT), ascorbic acid/ betacarotene/ biotin/ calcium/ chloride/ chromium/ copper/ folic acid/ iodine/ lycopene/ magnesium/ manganese/ molybdenum/ nickel/ nicotinic acid/ pantothenic acid/ phosphorus/ potassium/ pyridoxine hydrochloride/ riboflavin/ selenium/ silicon/ thiamine/ vanadium/ vitamin b12 nos/ vitamin d nos/ vitamin e nos/ vitamin k nos/ xantofyl/ zinc (CENTRUM SILVER FOR MEN 50+). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 23Jan2021 at 10:30 (at the age of 76-years-old) in the right arm and experienced pain in arm and fatigue. On 09Feb2021, the patient developed a bloody nose that was unstoppable at home. The reporter took the patient to the emergency room (ER), where his nose was packed, and he was kept overnight. The following day, while his nose was being unpacked, drooping of his face and mouth was observed. Tests for a stroke were negative on Feb2021. The patient was kept in the hospital for three days and was diagnosed with Bell's Palsy on 11Feb2021. The events "Bell's Palsy/drooping of his face and mouth" and bloody nose resulted in hospitalization/prolonged hospitalization in Feb2021 for 3 days. The patient's wife reported that as of 09Feb2021, he had swallowing issues when it came to solid foods and was looking for suggestions on what he can eat. The tongue was not swollen, and he was breathing better since the packing had been removed. As of Feb2021, the patient had chewing issues and cannot take solid food. The patient had vertigo before the second vaccination dose all the time, and experienced it again last night on 16Feb2021, he was dizzy and lightheaded. As of an unspecified date in Feb2021, the patient was weak and tired (did not have stamina). The patient was treated for "Bell's Palsy/drooping of his face and mouth" with prednisone 20 mg 2 tablets once a day and valacyclovir 500 mg 2 tablets twice a day. The patient was not treated for bloody nose and swallowing issues. The clinical outcome of " Bell's Palsy/drooping of his face and mouth", swallowing issues, chewing issues, weak, "tired / does not have stamina" was not resolved; bloody nose was resolved on Feb2021; "vertigo (dizzy / lightheaded)" was resolved on 17Feb2021.

Patient with history of TIA one week prior presented to the ED for recent onset of fever and epigastric abdominal pain. Pt found to have calculus of bile duct with acute cholecystitis and obstruction. In Ed pt had fever as high as 104 and pulse as high as 129. The gallbladder was found to be distended with wall thickening and large gallstone in the lumen. Patient transferred to tertiary care facility.

he violently threw up/vomiting; lost control of all of his extremities; acute pancreatitis; had no strength; affected his memory; barely moving; balance was horrible/his whole balance everything was off; lost his appetite right away; not eat; This is a spontaneous report from a contactable consumer reporting for the husband. A 76-year-old male patient received the first dose of bnt162b2 (Batch/lot number: EL3302), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included Allergy from an unknown date, blood pressure abnormal from an unknown date, ongoing kidney patient and was on dialysis three times a week. Concomitant medication included insulin aspart (NOVOLOG), insulin glargine, vitamin b complex (SUPER B COMPLEX), acetylsalicylic acid (BABY ASPIRIN), vitamin d3, ascorbic acid, biotin, folic acid, mecobalamin, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine (DIALYVITE), atorvastatin, cetirizine for Allergy, fish oil, docusate, amlodipine besilate for Blood pressure and other medications as the patient was kidney patient. For Concomitant medication amlodipine besilate, the consumer stated, Right now at this time he was not supposed to take them on his dialysis days. So, he took one tablet on Saturday & Sunday, Tuesday & Thursday. The patient had his first shot of the Pfizer on 21Jan2021, he lost his appetite right away and wasn't eating. And then on 29Jan2021 he took 2 bites of a meal, and had extremely volatile vomiting and lost control of all of his extremities. He violently threw up on the 29Jan2021 and from that's when on he had no appetite, she couldn't get him to eat anything. Her daughter had to help her pick him up of the floor, the Friday night 24 hours it was just horrible. The consumer stated, Saturday morning (30Jan2021) he had gotten use of extremities back but barely moving and still very, his whole balance everything was off. He was able stand up and use the restroom by himself. This had all affected his memory, he couldn't do his medications alone anymore and he couldn't take care of himself. And then on the 12Feb2021 the consumer took him over to the hospital because after when he vomited on the 29Jan2021 he lost all use of his extremities. They diagnosed him with acute pancreatitis, but he still, he was in the hospital from Friday 12Feb2021 and they released him on the 17Feb2021. And he still had no strength. His balance was horrible. It was affecting, whatever it was affecting his memory. The consumer stated they had no idea why he came down with acute pancreatitis and he never had any pain with it. They said they were amazed that he was not in severe pain, never any pain. The outcome of events had no strength and balance was horrible was not recovered. The outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187441 Same reporter/patient/product, Different dose/AE

Took Covid vaccine February 28, 2021, lack of sleep that night and next 2 nights. On March 3, 2021, about 12:30 am was sleepwalking until 7 am next morning. Kept getting up and going to bed about ever 10 to 15 minutes. Fell on his back once but did not wake up. Next morning (9 am), March 4, 2021, had bad taste in mouth. Rinsed mouth with mouthwash which helped. Was not hungry for breakfast. went back to bed at 10 am. got up at 10:30 am and said he felt bloated. gave him Pepto Bismol and he went back to bed. Slept approximately 3 hours. Ate soup and sandwich with no problem. was alert and at 100%. Said he felt good and didn't remember anything from previous night.

I developed stomach, intestinal pain, cramps. A continuous aching with a sharp pain about every 20 - 35 minutes. Lasting 36 hours. This was in my lower abdomen below belly button on the left side. Really quiet frightening, in that this was not in any material regarding side affects. I considered the emergency room Saturday night but didn't t go. Began to subside Sunday afternoon, leaving me sore to the touch. Only a little tenderness remains in the area. I have seen no physicians. I cannot speak to any permanent damage.

Lot of stomach cramps; had a lot of diarrhea; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number: EL8982, expiry: 30May2021) via an unspecified route of administration, on 31Jan2021 at a single dose, for covid-19 immunization. Medical history included neoplasm malignant (cancer), blood cholesterol ("cholesterol") and "blood pressure". Patient's concomitant medications were unspecified. On 01Feb2021, patient had a lot of diarrhea and a lot of stomach cramps for a week. He got it from a week ago today and he has been experiencing this and couldn't go to work. The outcome of events was unknown. Follow-up attempts are completed. Information about batch/lot number has been obtained.

I received the second Pfizer shot on March 1st. My initial reaction consisted of a couple of days of flu-like systems that abruptly went away. Then a week ago I came down with what appeared to be an intestinal bug. My subjective sense is that my immune system got confused and is now mounting random immune reactions - chills and fever, severe back pain, diarrhea, etc.

Within 1/2 hour of vaccine, patient states he had fever, chills, shortness of breath, aches, throughout the body - "eyeballs hurt" - "hair hurts" loss of appetite, lost his sense of taste, increased hoarseness, decrease O2 saturations.

Same evening of vaccine injection 3/24 - chills and severe headache and extreme fatigue. Overnight - nausea, vomiting and fever 102.6. Next morning 3/25, woke up and tried to get out of bed. Legs were so weak they gave out and I fell out of bed on the floor. I had no strength to get back up to get on the bed. My wife could not lift me, so she called 911 for a "lift assist". Paramedics were told I received the 2nd dose of the Covid vaccine the day before, so they picked me up off of the floor and put me back in bed. They took my vitals - blood pressure was 116/73 and temperature was still 102.6. Paramedics offered to take me to the hospital but I refused. Paramedics told my wife that if my breathing became labored, she should get me to the ER or call 911 again. I was not able to get out of bed the whole day on Thursday 3/25, because I was so weak I could not stand up, and I also had body aches and had to use a urinal because I could not walk to the bathroom. My wife gave me Tylenol and the fever finally broke late evening of Thursday 3/25 and I started to feel a little bit better. I had not eaten all day, but my wife made sure I stayed hydrated with water. On Friday morning 3/26 I was able to sit up on the side of the bed, and I was able to walk with the assistance of a cane to the bathroom. Extreme fatigue affected me all day Friday, but I did feel better. Fever did not come back after it broke. Saturday 3/27 - still experiencing extreme fatigue, but feel better overall.

12h after COVID vaccination awoke with severe bilateral muscle/buttock/leg pain, nausea, vomiting and ultimately some confusion and disorientation with possible left sided focal neurologic deficits. Sodium initially 127 on admission, but may have been artifact, as simultaneous venous blood gas electrolytes showed 135. On following day had platelet count of 115k, repeated at 90k

feeling unwell; muscle weakness; excessive tiredness; loss of appetite; fever; chills; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EP6955), via an unspecified route of administration administered in left arm at a pharmacy or drug store on 09Mar2021 10:30 AM as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and it was unknown if COVID was tested post vaccination. Medical history included hypertension. The patient had no known allergies. Concomitant medications included acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]), atorvastatin, and donepezil. On 10Mar2020 at 08:00 AM, the patient experienced feeling unwell, muscle weakness, excessive tiredness, loss of appetite, fever, and chills. The reporter considered the events as serious due to hospitalization. The events resulted in emergency room/department or urgent care. It was unknown if treatment was given for the events. The patient had not yet recovered from all events.

severe fatigue; severe sleepiness and sleeping like 20 hours a day; Cough; headache; lack of appetite; This is a spontaneous report from a contactable consumer reported for a male patient (Reporter's husband). A 76-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA) vaccine (Solution for injection, lot number: EN5318, Expiration date; unknown), intramuscular injection in right upper arm on 28Jan2021 05:00, at single dose for COVID-19 immunization. The patient's last weight was 242lbs, but on 07Jan2021 he weighed 257lbs. Reporter said that was considerable weight loss. The patient medical history included ongoing Diabetes, high blood pressure, High cholesterol, Sleep apnea, unspecified Small B Cell Marginal Zone Lymphoma. Concomitant medication included monthly B12 shots ongoing, unspecified route of Administration for underlying conditions such as lymphoma type cancer (Small b cell marginal zone Lymphoma). Patient taken medication for diabetes, high blood pressure, and high cholesterol no further details provided. On 28Jan2021, the patient experienced severe sleepiness, sleeping like 20 hours a day, Cough, Headache, lack of appetite and severe fatigue. The patient was taking treatment Nyquil taken for cough. The outcome of events were not recovered.

presented to the ER on 4/5 with a CC of diarrhea ongoing 5-6 days. found to be positive for c difficile. was in the er on 4/3 with similar complaints and c diff testing was neg. he was recently at another hospital for an out pt visit for an egd and esophageal stretching for achalasia and received botox injections. he was found to have a uti and was treated with vantin which he completed on 3/26. He got his covid vaccination on 3/29/2021. he was dc home on 4/7 on vancomycin po to complete a 14 day treatment course

Patient received his Covid-19 injection in home environment; administered by RN. Staff monitored him for 15 minutes following injection. He stated he was feeling in good health prior to injection and his stomach started "doing flip-flops" within approximately 30 minutes of injection. Symptoms progressed to severe abdominal cramping throughout day and developed nausea/vomiting in the evening. He called EMS the following morning.

experienced pain on hips, trunk, lower stomach and back; experienced pain on hips, trunk, lower stomach and back; experienced pain on hips, trunk, lower stomach and back; ache all the way around his waist; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: Unknown), via an unspecified route of administration in the left arm on 08Feb2021 14:00 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Feb2021, the patient experienced ache all the way around his waist from his front to around to his back and it is pretty intense. After receiving first dose, the next day on 09Feb2021, he experienced pain on hips, trunk, lower stomach and back. He saw on the article not to take ibuprofen, tylenol or advil. He spoke to his Dr. and said never heard about such an article. He wants to check with someone if he can take tylenol because of pain. The reported events were considered as non-serious by the health authority. The outcome of the events ache all the way around his waist was not recovered, for experienced pain on hips, trunk, lower stomach and back was unknown. Information on Lot/Batch number has been requested.

Could not sleep night the shot; Had chills; No appetite; could not have a bowel movement; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received first dose of BNT162B2 (solution for injection), via an unspecified route of administration, administered in left arm on 23Feb2021 14:00 (Batch/Lot Number: EWG200) at single dose for covid-19 immunisation. Medical history included covid-19. Concomitant medication included clarithromycin (CLARITIN [CLARITHROMYCIN]); atorvastatin calcium (LIPITOR), acetylsalicylic acid (BABY ASPIRIN) colecalciferol (VITAMIN D). No known allergies. The patient not had other vaccine in four weeks. The patient was not tested for COVID post vaccination. The patient could not sleep night the shot. He had chills, chills stopped after 16 hours, No appetite, could not have a bowel movement on 23Feb2021 at 02:00 PM. Outcome of chills was recovered on 24Feb2021 and outcome of other events was recovered on an unspecified date of 2021.

Diverticulitis; Worsening parkinson's symptoms.; cough lasted 3 weeks; headaches; feel week; imbalance; unable to move legs; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received bnt162b2 (Pfizer, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 06:00 to 16Feb2021 06:00 (at the time of 76-yers-old) as single dose for covid-19 immunisation. Medical history included ongoing parkinsonism, high blood pressure and asthma. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR); losartan, omeprazole, dopamine and silodosin (RAPAFLO). The patient previously took bnt162b2 for covid-19 immunisation (Covid 19;Pfizer,Lot unknown; time; 05:00 AM, Vaccine location; left arm, dose; 01). The patient had worsening parkinson's symptoms. 2 days post vaccine, unable to move legs. cough lasted 3 weeks, and experienced headaches. Patient continues to feel week and has imbalance. Also had a case of diverticulitis on 18Feb2021. The event diverticulitis was considered as medically significant. The patient not received treatment for the adverse events. The outcome of events was resolved with sequel on 2021 (unspecified date). No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Liquid diarrhea (severe) that did not respond to over-the-counter treatement. Eventually responded to Pepto Bismol treatment on a daily basis. Still having symptoms and using Pepto Bismol.

His arm was sore; Nausea; Headache; Fatigue; This is different feeling than what he normally feels; This is a spontaneous report from a contactable consumer (patient's wife). A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264, Expiration Date: 31May2021) via an unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. Medical history included diabetes mellitus. On 04Feb2021 the patient experienced his arm was sore, nausea, headache, fatigue. On an unspecified date Feb 2021, the patient experienced this is different feeling than what he normally feels. The reporter stated, Yes, he takes a lot, I would rather not because its lot he is diabetic and he takes blood thinner and statin and its very long list, but these are different so those, the reason I called because this is different feeling than what he normally feels when he gets ups in the morning, and that's why I thought maybe it because of Covid. The patient underwent lab tests and procedures which included glycosylated hemoglobin, diabetes, I do I have to look up the result and the date, the date was 30Jan and it was blood draw for his A1C. The outcome of event different feeling than what he normally feels was unknown and other outcome of the events was not recovered.

Altered sense of taste to foods some worse than others . Taste of some foods so bad causing gagging and unable to swallow the food. This lasted for 4 weeks and slowly improved over time . Sense of smell not affected.. lost weight as not able to eat much

Patient presented to ED on 3/15/2021 with fatigue, subjective fevers, dry cough, and diarrhea found to have COVID pneumonia. CT PE negative at that time. Hospitalization complicated by RUE superficial cephalic vein thrombus, epistaxis, GIB, gluteal abscess, and AKI. Patient made DNR. Suspected cause of death: ventricular tachycardia secondary to renal failure and metabolic abnormalities in the setting of COVID ARDS.

stomach aches; he's got the shakes; his right back, shoulder and back of his neck, his legs, his trunk of his body are sore, everywhere his muscle are sore; Diarrhea; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 25Dec2020 (Batch/Lot Number: EL9261; Expiration Date: 31May2021) as single dose for an unspecified indication. Medical history included myocardial infarction from an unknown date and unknown if ongoing (He had 2 heart attacks and open heart surgery and he is sick of this already), cardiac operation from an unknown date and unknown if ongoing (He had 2 heart attacks and open heart surgery and he is sick of this already) rhinorrhoea from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 28Dec2020, the patient experienced diarrhea, stomach aches, he's got the shakes, his right back, shoulder and back of his neck, his legs, his trunk of his body are sore, everywhere his muscle are sore. Patient says the 25th of last month, 25Dec he got his first shot, that was 14 days ago and 3 days after he got diarrhea it was pretty severe but then that cleared up and he was ok for few days and then he got stomach aches, the stomach aches woke him up at 5o'clock in the morning and then he had the stomach ache 03Feb. It was 3 times he had the stomach aches. Today he's got the shakes but he also has Parkinson's so a lot of things amplify his Parkinson's, so he is not overly concerned about the shaky thing. shaky thing happens periodically to him but it is pretty bad today. What he did to rectify is he took his normal medicine and he has taken an antacid on those days when he had the stomach ache and one other thing, the second thing was the stomach aches and also his right back, shoulder and back of his neck, his legs, his trunk of his body are sore, everywhere his muscle are sore and he is having a runny nose, the runny nose is the last thing but at the same time the runny nose was happening prior to taking the shot so that might not be related. He is calling to see if those things are associated with the vaccine. During that time period of time he took his temperature and he did not have a fever at any time. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.

Headache; nausea; diarrhea; weakness; fatigue; 99.5 temp; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL926), via unspecified route of administration in left arm on 18Feb2021at 08:30 as a single dose for COVID-19 immunization. The patient medical history included Hypertension, hyperlipidemia, acid reflux. The patient concomitant medication included fenofibrate, atorvastatin, atenolol, lisinopril. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient has allergic to cephalosporins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021, the patient experienced headache, nausea, diarrhea, weakness, fatigue, 99.5 temp. The patient did not receive any treatment for the events. The outcome of the events Headache, nausea, diarrhea, weakness, fatigue, 99.5 temp was recovered.

Could not eat all next day - slept around the clock.; 27 hours later nausea; headache; muscle ache; temperature of 99.5; discolored (orange) urine.; 1st day - sore arm only.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK 32 48), via an unspecified route of administration, administered in Arm Left on 30Jan2021 at 17:45 as single dose for COVID-19 immunization. Medical history included high blood pressure. No known allergies were reported. Concomitant medications included atorvastatin calcium 40 mg, Metoprolol succinate 25 mg, Colecalciferol (D3) 25. 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 vaccination patient was not tested for covid-19. On 30Jan2021, first day after vaccination, the patient had sore arm only. On 31Jan2021 at 10:00 pm, 27 hours later of vaccination, patient experienced nausea, headache, muscle ache, temperature of 99.5 and discoloured (orange) urine. The events were considered nonserious. Patient could not eat all next day and slept around the clock, drank a little bit of bubbly water. After 48 he later patient began to feel a little better and ate some grapes. The patient had not yet recovered from the events.

This is a spontaneous report from a contactable physician. A 76-year-old male patient received BNT162B2 (BNT162B2), dose 1 intramuscular on 25 Feb 2021 (Batch/Lot Number: EN6198) at single dose for COVID-19 immunization administered at clinic. Medical history included hypertension, blood cholesterol increased, myocardial infarction, colon cancer (had surgery for that and also had chemotherapy), coronary artery disease (30% blocked coronary artery), covid-19 from 19May2020 to an unknown date. Concomitant medication(s) included lisinopril for hypertension; amlodipine; rosuvastatin for blood cholesterol increased; evolocumab (REPATHA), subcutaneously at 140 mg (twice a month) for blood cholesterol increased. The patient reported, he was diagnosed positive with COVID-19 on 27May2020 from which he seem to have recovered without any residues of symptoms or side effect. He received first Pfizer COVID vaccination at noon time this past Thursday 25Feb in a vaccination clinic set up, the following day Friday the 26 he woke up the next morning and entire body was so sore from head to toe and could hardly get himself out of bed, but when he got up, he was having difficulty walking, so anyway he stayed in bed all day on 26 and 27. He initially had a slight temperature, some chills, slight cough, runny nose and those symptoms except for the cough seem to have resolved, what hasn't resolved is about every 30 or 40 minutes or so he had been having to urinate ever since 26Feb2021 night, his mouth has been constantly very dry. Still urinating every half hour 45 minutes and ongoing. Mouth has been very dry and had a couple of areas where it seems like maybe he had bit his lip or something, maybe when he was sleeping. It was nothing like that in mouth anymore but the mouth is still constantly so dry like dehydrated and no matter how much of fluid he drank that doesn't seem to help it and what in fact has also caused was on yesterday morning he had been a little constipated on Friday night and then yesterday morning had a severe case of diarrhea. Now he had not had another bowel movement since yesterday morning as no appetite and feeling so lousy, and so tired and fatigued. He had been feeling even much worse since getting the vaccine. He still feels very fatigued, very sore all over, very tired, still have the slight cough and he would say that's about it. Outcome of events for cough, pain and tiredness was not recovered and for the rest of the events it was unknown. No follow-up attempts are possible. No further information is expected.

Ischemic stroke with paralysis on left side of body, impaired speech, swallowing, cognitive functioning

flu; flu like symptoms; fever; vomiting; diarrhea; malaise; dizziness; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 04Mar2021 at 10:00 am (at the age of 76 years old) (Lot Number: El9266, unknown expiration) as a single dose for COVID-19 immunisation. Medical history included prostate cancer. No known allergies. Concomitant medications included levetiracetam (KEPPRA); ascorbic acid (VIT C); acetylsalicylic acid (BABY ASPIRIN); calcium, colecalciferol (CALCIUM +D3). The patient also received first dose of BNT162B2 on 11Feb2021 at 14:00 (at the age of 76 years old; lot number: El3246, unknown expiration) in left arm for COVID-19 immunization. On 05Mar2021, after 2nd shot, the patient just feeling flu like symptoms. He was hospitalized on 26Mar2021 in an emergency situation with fever, vomiting, diarrhea (which started on 04Mar2021). The patient was released from hospital on 29Mar2021 with diagnosis of flu (unspecified date). The patient still experiencing malaise (unspecified date) and dizziness on 14Apr2021. The patient received antibiotics and diarrhea medication. The events flu like symptoms, fever, vomiting, diarrhea, and flu resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive other vaccine in four weeks. The patient had no COVID prior to vaccination and had nasal and throat swab on 18Mar2021 with negative result. The patient had not yet recovered from flu like symptoms and malaise, while unknown outcome for the remaining events. The events flu like symptoms, fever, vomiting, diarrhea, and flu were assessed as serious (hospitalization). No follow-up attempts are possible. No further information is expected.

temp to 100; weakness; fatigue; nausea; diarrhea; This is a spontaneous report from a contactable physician, the patient. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6206, second dose) solution for injection intramuscular in the left arm on 11Mar2021 at 08:20 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high from 2010, ongoing high lipid from 1980, and ongoing esophagitis from 1975. Concomitant medications included ongoing atenolol for blood pressure high from 2010, ongoing lisinopril for high blood pressure from 2010, ongoing atorvastatin for high lipids for greater than 10 years, ongoing fenofibrate for high lipid for greater than 10 years, and ongoing lansoprazole (PREVACID) for esophagitis for greater than 10 years. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 (first dose, lot EL9266) for COVID-19 immunization on 18Feb2021 and experienced headache, nausea, diarrhea, weakness, fatigue, and 99.5 temp (fever). The patient experienced moderate weakness, fatigue, Temp to 100 F, Nausea + diarrhea x2 in Mar2021. Treatment for the event fever included liquid Rx-TYLENOL at 500 mg twice. The outcome of the events weakness, fatigue, Temp to 100, nausea, and diarrhea was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Fever 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.

Had average Saturday at home, no illness. Layed in bed talking. Became nauseated, got up to vomit. Went back to bed, talking again. Said something wasn't right. Massive Heart Attack and Immediate Death. Police arrive in 2 minutes to begin CPR. Medic soon after. Efforts to resuscitate unsuccessful.

Chills, Pain all over the body, Palpitations, loss of appetite.insomnia. Today May 10, finally feeling better. Took Tylenol (1000 MG) as of Saturday night.

Acute pancreatitis; No appetite/he was starving himself to death; he lost all use of his extremities; Still not eating and is so weak/No energy/he still has no strength; Whole balance everything was off/His balance is horrible; he took 2 bites of food and vomited; Dizziness; Still not eating and is so weak; Affected his memory; This is a spontaneous report from a contactable consumer (patient wife). A 76-year-old male patient received second dose of BNT162B2 (mRNA PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262; 76-year age at the time of vaccination), via an unspecified route of administration on 09Feb2021 as single dose for COVID-19 immunization. Medical history included allergy, blood pressure, kidney patient (on dialysis three times a week, so he was a kidney patient). Concomitant medication(s) included Insulin aspart (NOVOLOG) (He takes Insulin with each meal he takes 6 units of NovoLog with his Demeter 6 units), Amlodipine besilate (5 mg tablet) taken for Blood pressure as 5 mg (one tablet on Saturday and Sunday, Tuesday and Thursday), Atorvastatin (40 mg tablet), 40 mg daily, Acetylsalicylic acid (BABY ASPIRIN) daily, Cetirizine (5 mg tablets) for Allergy at 5 mg daily, Ascorbic acid, biotin, folic acid, mecobalamin, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine (DIALYVITE) daily (1 pill daily), Docusate (DOCUSATE capsule) by oral 1 DF, 2x/day (One capsule by mouth twice a day), Fish oil (100 mg capsule) 100 mg, 2x/day orally, insulin glargine 1x/day (At bed time he takes 8 units of his Insulin glargine), Vitamin B complex (SUPER B COMPLEX [VITAMIN B COMPLEX]) and vitamin D3 daily; patient was taking other medications for kidney. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3302; 76 Year age at time vaccination) on 21Jan2021 for COVID-19 immunization and experienced lost his appetite right away, extremely volatile vomiting, lost control of all of his extremities, this has all affected his memory, acute pancreatitis, barely moving, balance was horrible/his whole balance everything was off; had no strength. It was reported patient received his 1st Pfizer vaccine shot on 21Jan2021. He "lost his appetite right away and wasn't eating." Then on 29Jan2021 he took 2 bites of a meal, and "had extremely volatile vomiting and lost control of all of his extremities. My daughter had to help me get him up from the floor." the next day "he was able stand up and use the restroom by himself. This has all affected his memory, he cannot do his medications alone anymore and he cannot take care of himself." 09Feb2021 he received the 2nd vaccine dose. "Again that night he took 2 bites of food and vomited. The next day, he still had no appetite, he took shower and then went to bed with dizziness (10Feb2021) and no energy." stated she took him to the (hospital name) on 12Feb2021 and he was admitted to the (hospital name) with "acute pancreatitis (Feb2021) and was released on the 17Feb2021. They should have kept him longer, because he is still not eating and is so weak (Feb2021), I am worried." Further stated, " He had his first shot of the Pfizer on 21Jan2021 and then he violently threw up on the 29Jan2021 and from that's when on he had no appetite, I couldn't get him to eat anything. And then he had his second shot on the 09Feb2021. On Thursday, the 11Feb2021 he violently threw up again after taking two bites of food. And then on the 12Feb2021 I took him over to the (hospital name) because after when he vomited; he lost all use of his extremities (Feb2021). My daughter and I were having to pick him up of the floor, the Friday night 24 hours it was just horrible. Saturday morning he had gotten use of his extremities back but I mean barely moving and still very, his whole balance everything was off (Feb2021). Now when I took him into the hospital they diagnosed him with acute pancreatitis, but he still, he was in the hospital from Friday the 12Feb2021 and they released him on the 17Feb2021. And he still has no strength (Feb2021). His balance is horrible. It was affecting, whatever it is affecting his memory. the medical records when he went in the hospital and everything if they would like. They have no idea why he came down with acute pancreatitis and he never had any pain with it. They said we are amazed that he was not in severe pain, never any pain. I want to find out if they feel that it had anything to do with the vaccine and if it did if there's anything we can do to improve because he is terribly, terribly getting worse." also stated, "He started experiencing the problems right with in that time period of him getting both shots." Also reported, Affected his memory in Feb2021. Reporter stated, "Because I didn't know, he was starving himself to death (in Feb2021) he couldn't hold anything down. He wouldn't eat and when I went (incomplete sentence)" The seriousness was reported as hospitalization for the events Acute pancreatitis; Appetite lost; Muscle disorder; Asthenia. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021191555 Same reporter/patient/product, Different dose/AE

sore arm other than injection site; light headedness; mild diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received first dose of bnt162b2(BNT162B2; formulation: solution for injection; Lot number el9264) via an intramuscular route of administration in left arm on 27Jan2021 at 03:00 PM (Age at vaccination: 76) as single dose for COVID-19 immunization at workplace clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no Allergies to medications, food, or other products and the patient received other medications within 2 weeks of vaccination, but unspecified. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 at 09:00 PM (the date of the vaccination), the patient experienced sore arm other than injection site, light headedness, mild diarrhea. The patient did not received treatment for the adverse event. The outcome of the events was recovered. Follow-up attempts are completed. No further information is expected.

ED to Hosp-Admission Discharged 4/28/2021 - 5/4/2021 (6 days) CRNP Last attending ? Treatment team COVID-19 virus infection Principal problem HPI: For complete history and physical see the H&P dictated by Dr. on 4/28/2021. This is a 76-year-old male who presented to the emergency department with upper respiratory symptoms for three days. He reports having cough, sneezing, runny nose and poor appetite. His caregiver had Covid recently and he was exposed. He was admitted for further evaluation and treatment. Hospital Course: Patient was admitted inpatient to the medical surgical floor. He was not on telemetry. Patient reports that his caregiver had recently tested positive for Covid and he was exposed. He has been having upper respiratory symptoms including cough, sneezing, and runny nose. His COVID-19 test was positive. He was started on the COVID-19 treatment protocol which included IV remdesivir and IV dexamethasone. He underwent a CT scan of the chest which showed small patchy areas of groundglass infiltrates in the peripheral portions of the left and right upper lobes and also the posterior aspects of the right lung base. These findings are probably due to pneumonia. Hospital course consisted of gentle hydration with IV normal saline. He was also started on antibiotic therapy oral azithromycin and IV Rocephin. He had completed the course of antibiotics while on the unit, therefore, at the time of discharge no antibiotics were prescribed. He initially was hypoxic and started on nasal cannula oxygen to maintain pulse oximetry greater than 92%. Eventually, oxygen was weaned and pulse oximetry on room air has remained in the 95-96% range. He has a history of diabetes mellitus and while on the unit blood glucose levels have fluctuated. His point-of-care glucose have been in the 80-500 range. He has had numerous episodes of hypoglycemia and insulin has been adjusted. The fluctuations of the blood glucose levels may be secondary to IV dexamethasone. At the time of discharge he will continue dexamethasone 6mg daily for the next three days. He was advised to increase insulin 70/25 insulin five units daily for the next thre days. After that time he can return to his normal dose of insulin. He also had been treated with IV remdesivir and had completed the 5-day course. On examination today he has been asymptomatic. He denies any chest pain, dyspnea, abdominal pain, nausea, or vomiting. The initial lab studies showed an elevated creatinine level, although he has a history of chronic kidney disease. At the time of discharge the creatinine level trended downward and he was advised to follow-up with the primary care provider for possible repeat BMP in 1 to 2 weeks. All other lab studies have been within normal limits. The systolic blood pressure has been in the 120-150 range. The most recent systolic blood pressure was 151/66 mmHg with a heart rate of 66 bpm. He denies any lightheadedness or dizziness. He was advised to continue all of his current medications. While on the unit he was in isolation secondary to COVID-19. At the time of discharge he should maintain social distancing/isolation, mask wearing and good handwashing. He will will need to follow-up with the primary care provider. He was also advised if the oxygen level dips below 89% he will need to return to the emergency department. At this time he is resting comfortably, offers no complaints and is stable for discharge. Patient is alert, oriented answering all questions appropriately. He is continent of bowel and bladder. Heis able to make his own decisions. He is able to performhis own ADLs. . At this time he is in agreement with the plan and feels comfortable to be discharged home. Thank you.

he did not feel well; he then got tested for covid and tested positive for covid; he just did not feel like himself and still thought it was from the shot and he was not 100 percent it seemed; he did not want to eat but could smell and taste food but did not want to eat it/ loss of appetite; he started feeling drowsy/ kept falling asleep/ dozing off; the next day started feeling very tired/ tiredness; lost about 12 pounds; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 18Feb2021 10:30 (Batch/Lot Number: EN5318) at the age of 76-years-old as first dose, single in the left arm for COVID-19 immunisation. Medical history included acute pancreatitis, diagnosed about 10 years ago (2011) and cirrhosis liver, diagnosed maybe 7-8 years ago. The patient's concomitant medications were not reported. The patient previously took Hepatitis A vaccine on 03Feb2021 and has no dosage, lot number, expiry date to provide. The patient stated that he was calling about the Pfizer COVID vaccine and stated that he had the 1st dose on 18Feb2021 10:30 and did not get the 2nd dose; stated that he had the first dose and the next day (19Feb2021) started feeling very tired and thought it was a result of the shot and it lasted until the following Friday, 26Feb2021 and he then got tested for covid and tested positive for covid on Friday 26Feb2021. The patient stated that his healthcare professional (HCP) sent him for an infusion that day and hooked him up to the infusion and said it would help him get better faster and the patient does not know the name, dosage, lot, expiry date of the infusion and has none of that information to provide. The patient stated that he was told he can't get the 2nd shot for 90 days after the infusion and heard that he could get it and the infusion center told him he would have to start all over again with the 1st shot of the Pfizer COVID Vaccine and he does not know but has heard different stories and some say he can get the 2nd dose of the vaccine and others say no he has to wait 90 days after the infusion and he called the facility and the HCP said he would have to wait 90 days after the infusion; states the facility said to wait 90 days and he was told they are going by the agency. The patient stated that his patient card for the Pfizer COVID Vaccine says he was supposed to go back for the 2nd dose on 11Mar2021. The patient also stated that when he went home after the Pfizer COVID Vaccine 1st dose he felt fine and got up and went to work and was fine and then noticed at work he started feeling drowsy (on 19Feb2021) and usually works in the street outside but was in the office that day; patient stated that he started dozing off and then the next day on Saturday (20Feb2021), he just did not feel like himself and still thought it was from the shot and he was not 100 percent it seemed and he went to go to work the following Monday and Tuesday and Wednesday and kept falling asleep in his office and then it was finally Friday. The patient also stated that he did not want to eat but could smell and taste food but did not want to eat it on 19Feb2021 and the following week he took the whole week off of work and lost about 12 pounds; he also stated that the tiredness lasted into the following week and the loss of appetite, dozing off is not ongoing and lasted probably a good three weeks total until he started feeling from the day after the vaccine on 19Feb2021 for three weeks and then he started feeling more like himself. The patient stated that he was fine up until he did not feel well and it was not probably from the vaccine but was just a coincidence the next day when he started feeling tired and he does not know the results from the vaccine but got worse and worse and could not function normally like he is supposed to and just wanted to lay down. The patient stated that he did not have treatment for the reported events. The outcome of the event "the next day started feeling very tired/ tiredness" was recovered on 26Feb2021, for events: decreased appetite and somnolence was recovered on an unspecified date. The outcome of all other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

extreme muscular fatigue/discomfort on exercise, "trigger finger" in both hands, diarrhea, sometimes explosive. Course - persisting since mid-April - unresolving muscular fatigue, continuing bilateral joint stiffness in hands, left thumb continues to have trigger finger.

he had to have passed out; he defecated himself among other things; could not move; the fatigue.; This is a spontaneous report from Pfizer-sponsored program. A contactable consumer, the patient, reported a 76-year-old elderly male received the second dose of BNT162b2 (solution for injection; Lot EWO187 expiry information not provided) as a single dose via an unspecified route on an 19May2021 (at 76 years-old) for COVID-19 immunization. Relevant medical history included ongoing Type V hyperlipidaemia (12Aug2020), ongoing Coronary artery disease (31Oct2018), ongoing elevated Prostatic specific antigen (PSA; 10Jun2014), ongoing extradural extramedullary spinal tumor (04Apr2018), ongoing Dizziness (04Apr2018), ongoing Obesity (03Mar2021), Acute kidney injury (AKI), swelling of joint right upper arm, urinary tract infection associated with indwelling catheter (05Jun2020), pneumonia due to COVID-19 virus (hospitalized for two and one half months; 26Apr2020-02Jun2020), pneumonia due to COVID-19 virus (05Jun2020), restless leg syndrome, depression, and Atrial fibrillation (Afib), stent in his heart, and chest pain. Concomitant medications included pramipexole dihydrochloride for restless leg syndrome from unspecified date; venlafaxine hcl for depression from 1992; atorvastatin calcium (LIPITOR) for unspecified indication from unspecified date; SOTALOL for Afib from an unspecified date; tamsulosin hydrochloride (FLOMAX) for unspecified indication from unspecified date; apixaban (ELIQUIS) for unspecified indication from unspecified date; and esomeprazole magnesium (NEXIUM) for unspecified indication from 1998. The patient also received unspecified concomitant medications for the stent in his heart though he could not recall the name. The patient received the first dose of BNT162b2 (solution for injection; Lot EWO171 expiry information not provided) as a single dose in the left upper arm an 19Apr2021 (at 76 years-old) for COVID-19 immunization and experienced no adverse effect. The patient reported that on 19May2021 when he got home, he passed out and had to be taken by ambulance. When questioned, the reporter stated he had to have passed out. The patient reported that de does not really know, except he could not move; described as 'had a heck of a time moving'. The patient reported that he literally defecated himself among other things. The patient reported that his neighbor heard him screaming and called an ambulance who took the patient to the hospital, the emergency hospital and then the hospital itself. The patient reported that he was hospitalized from 21May2021 to 24May2021. The patient yawned and stated that this was another problem, the fatigue. The outcome of the events passed out, defecated himself, and could not move was recovering. The outcome of the fatigue was unknown.

nausea; Headache; Fatigue; different feeling than what he normally feels; His arm was sore; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 23Feb2021 14:02 (at the age of 76-year-old) (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included diabetes from 1996. The patient's concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN9264) administered in the right arm on 02Feb2021 (at the age of 76-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization where patient also experienced his arm was sore. On 24Feb2021, the patient experienced nausea, headache, fatigue, different feeling than what he normally feels, and his arm was sore. The onset time for the events headache and nausea was at 09:00. The patient was admitted to the hospital due to the events nausea, headache, fatigue, and different feeling than what he normally feels. The events did not require emergency room and physician office visit. There was no treatment received for all events. On an unspecified date, the patient recovered from all events. Follow-up attempts are needed. Further information has been requested.

I had a severe reaction to my 2nd Pfizer shot with projectile diarrhea for 3+ days! This seems unlikely since it occurred 9 days after the shot but there's no other explanation. This left me so dehydrated that I went into AFIB and had to visit Emergency Room.

Right after the vaccine, I had a slight ache at the injection site - that lasted a couple of days at the most. June 12th, I had a diarrhea. The surgeon who took care of my rectum - his office ordered a stool sample. I picked it up and took it back the same day - positive result for C Difficile - oral solution of Vancomycin - 2.5 ml every 6 hours for 10 days. I see the surgeon for the post op check on July 13th and maybe he'll re-test at that time.

Lost weight; He had no appetite; Stomach cramps; Dehydrated; Tired; no energy; Confused; Headache; Diarrhea; Not digesting food; This is a spontaneous report from a contactable consumer (patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection; Lot Number: EL9269), in left shoulder on 13Feb2021 06:30 as dose 1, single for covid-19 immunisation (76 years old when vaccinated). Medical history included damaged his thumb a couple of years ago. There were no concomitant medications. The patient reported that he got the shot this morning. After he got the shot on 13Feb2021 he had to wait for 15 minutes before he could leave. While waiting the 15 minute time period he got a slight headache at that time. He later stared to drive home and realized he was feeling confused. He decided to get something to eat and that did make him feel better. However, he felt like he was not digesting his food all day. He felt like he was still bloated. He was not processing the food he had eaten. He added, the food he did eat he thought the eggs were not done. Normally, he would not eat them, but he was in a hurry. After that he did not eat any food. He was unable to eat any food. Later that day he began to have a bad reaction. He felt extremely tired. He then started to lose his body fluids. He would sit down and it would run out of him. He decided to quarantine himself. He stated he could not use the internet because he lives in a place where they do not have internet. He was tired, had no energy. He just kept losing body fluids constantly. He has lost weight. He felt dehydrated. Stated he did not have a fever. He had a thermometer and was checking it every hour. It felt like at the time when events first started he was getting worse and worse and so he just laid there. He stated he does not know his current weight. He was dehydrated so bad. He lost so much weight his shoes does not even fit his feet. Later, he confirmed he no longer has a headache. He last had a headache slightly yesterday. He added that the headache could have also occurred due to lack of eating. He had no appetite. He was unable to provide if recovered completely or recovered with lasting effects when probed for outcome. He stated he just felt ran down. He clarified losing body fluids as he had like water, like diarrhea, it was running right out like it would out of a body bag. He could not stop it from coming. It would happen every few minutes. He confirmed that he no longer has diarrhea. He had started taking Kaopectate. He reported that he last had diarrhea a little yesterday morning. He does not have it anymore. He just has no energy left. He would lay down because he was so tired and then he started having the diarrhea and it kept getting worse and worse. He ate a little this morning, a breakfast roll. The day he got the vaccine he was so tired. He slept a lot. This was early afternoon. He got up because he realized he had made a mess with the diarrhea. He started having stomach cramps the night of 13Feb2021. He had some when he laid down. He still had some last night when he laid down. He does not know if the stomach cramps have resolved yet, stated he is still waiting to see. He will have to see when he lies down. However, he is trying to get out and about to get some things done and get something to eat. He stated he was taking Tylenol, but the Tylenol was mainly for the stomach cramps. By 14Feb2021 he started to feel dehydrated. He felt that by then he had already stopped up the sewage system. He was taking electrodes from (Pharmacy) due to the dehydration. He knew this was going to be a problem. Therefore, someone went out and got this for him. He stated that he feels better overall. He will truly see when he tries to get something to eat. He stated he does not take any medications whatsoever on a regular basis. He added, the guy who gave him the shot caller does not believe he has given too many shots before. He thought he was a rookie. He stated he went too high to begin with. He said that normally, shots don't hurt with him and this time it did slightly. He reported that he gets the flu vaccine every year. He was supposed to get the second shot 06Mar2021, but he was not sure about if he should get it and has questions about that. The outcome of the event headache was recovered while diarrhea, he had no appetite, lost weight and confused was not recovered. The outcome of the event not digesting food, dehydrated and stomach cramps was unknown while the outcome of tired; no energy was recovering. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

Wife stated that Husband passed after receiving dose of Pfizer vaccine, he developed a Guillain-Barre Syndrome after receiving vaccine. Wife stated that he lost ability to walk, ability to speak was severely impacted, had difficulty eating and drinking bc his throat muscles were effected from the syndrome. Then, he couldn't sit up in bed. Then, after was diagnosed that's when his kidneys started to fail and then his heart stopped. DOD: 04/06/2021

developed flu-like symptoms after two weeks. Nausea. Loss of appetite. Wife admitted for renal failure. Patient admitted for acute on chronic heart failure. Now with gouty arthritis. Patient states it?s too much of a coincidence. They will not take another dose.

vomited; nausea/ felt sick to his stomach; felt woozy; didn't feel well; right deltoid soreness; This is a spontaneous report from a contactable physician (patient). A 77-years-old male patient received the first dose of BNT162B2 (Lot: EH9899), via an unspecified route of administration in deltoid right, on 24Dec2020 11:30 at single dose for COVID -19 immunization. Medical history included pulmonary embolism half a dozen years ago. He has had no problems with Deep Vein Thrombosis or pulmonary emboli since then, since half a dozen years. He has had a battery of lab tests 2 months ago, his blood glucose was high, it was 106 mg. The potassium was ok. He has had no issues with vaccines in the past. He had an antibody test last Jul2020 because he had bacterial lower urinary tract prostate infection. Concomitant medication included rivaroxaban (XARELTO) at 10 mg a day and cefalexin sodium (CEPHALEXIN) at 500 mg three times a day, well approximately 3, sometimes he forget a dose. The physician reported possible side effects of Covid vaccine. The physician received the vaccine on 24Dec2020 at 11:30 in the late morning and felt fine. He woke up on 25Dec2020 and at 2:30AM he was sick to his stomach and vomited and didn't feel well the rest of the day. Since then he had been okay, he had occasional nausea and vomiting. He clarified that on 24Dec2020, in the late evening, his appetite which was usual, was robust. Then on 25Dec2020 at 2:30 in the morning he vomited, and had no trouble since then. From what he read, nausea and vomiting are observed following the injection. On 24Dec2020 just before bed, he had a light supper, his appetite was robust, then unexpectedly he woke up sick to his stomach and went back to bed on 25Dec2020. He clarified that he had not vomited since the one episode on 25Dec2020. He also added that he has not been nauseous since then. Caller also added that he felt a little woozy on Holiday 25Dec2020, it only lasted up until the evening of 25Dec2020. He had the 1 episode vomiting on 25Dec2020 and felt woozy until late evening of 25Dec2020. His right deltoid where he received the vaccine was a little bit sore on 24Dec2020, and he was still having a little bit of soreness, it is slight, not very tender, he is unable to do usual morning exercises with out noticing the discomfort, the exercise he is doing is chin ups, the soreness is not intense and it never was. The lab test in 2020 included Height: under 5 feet 5 inches. Weight: about 165lbs or 167lbs. He had no positive test for COVID prior to the vaccine. All the tests were negative. The 1st one was nasopharyngeal, and all the next ones after were nasal swabs. He thought they are all reverse transcriptase tests. The last time he had a COVID test they did a nasal swab, it was this morning, and before that was last Monday or Tuesday, but he thought more so Monday. He had one PCR test. The outcome of the events vomited, nausea and felt woozy was recovered on 25Dec2020. The outcome of the event right deltoid soreness was recovering. The outcome of the other event was unknown. The 2nd dose for Covid vaccine was schedule for 14Jan2021.

Patient states that he had vaccine on 1/13/21. He presented to the clinic 4 days later on 1/17/21 with light headedness, nausea and elevated BP 160/88 and upon recheck 175/100. There is H/O HTN but on medication he has not been this elevated in years.

Cough, congestion, shortness of breath, diaphoretic, Temp of 99 degrees F, nausea, oxygen saturation dropped to 88% on room air

Day of injection (01/28/2021) plus 3 hours Approx 12 noon. 4 bouts of Diarrhea lasting several hours. Two days post injection (01/30/2021) 11:A.M. 2 bouts of Diarrhea over two hour period. Two days post injection (01/30/2021) 10:00 P.M. Broke out in a full body sweat, weakness with heart rate 120 bpm. Cooled off by using cool wet towels and rested for two hours. Heart rate down to 75bpm. Heart felt like skipping beats for another hour. Now Sunday morning (01/31/2021) and feel normal

he doesn't have any energy, he is real low on energy; real sick; tired; freezing to death; Chills; Diarrhea; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Jan2021at single dose for COVID-19 immunization. Medical history includes hearing aids user from unknown date. There were no concomitant medications. On 17Jan2021 Sunday, the patient was freezing to death, had chills and diarrhea and still has them right now. The patient was fully aware that second dose is on 04Feb2021, and wants to know more information, is this going to continue, etc. The patient stated he was real sick, but while being sick, he read the papers, and it actually told him, this was supposed to happen. He was supposed to have chills and fever and all that, and by golly his body has done a good job of that. The real thing is, he is fine with taking it again, but after such a reaction, he wants to know if it is safe to take it again. The patient stated he lost one of his hearing aids, he needs to have another one sent, he had a terrible day yesterday. His symptoms came on in the middle of night, got in clothes stayed in bed. He has no primary care doctor, he has one here but doesn't know if he wants to mess with him. For events freezing to death and chills outcome was the he feels good, he was not chilling or doing anything anymore, but one thing that is bothering him, he doesn't have any energy, he was real low on energy. The freezing to death and chills started leaving yesterday morning, and went away over the day, he is just kind of down with it, just tired. He doesn't know why. The diarrhea didn't hang around a long time. The outcome of the events freezing to death, chills and diarrhea was recovered on unspecified date. The outcome of the remaining events was unknown. Information on the Lot/Batch number has been requested.

fever 102-chills- unable to walk-disorientated-loss of appetite-dizzy- we had to take him to his Dr in a wheelchair on Monday ,February the 1st. Doctor put him on covid meds and he is still to this date (Feb. 6th) still weak . we had a covid test done and it was negative.

Low-moderate pain below abdomen followed by frequent and excessive passing of wind for about 4 hours. Peptide pills reduced problem and permitted sleep. Food ingested during the day was very unlikely to be the cause. Condition disappeared by 8:00 am 2/6/21.

Patient was vaccinated at 11:30am. By 7pm he started presenting symptoms of fatigue, chest pain. Patient urinated and defecated in himself. Was not feeling well. Patient died at 10:30pm.

Headache; Horizontal red line of swelling at the injection site; Horizontal red line of swelling at the injection site; Nausea; Circular rash on the shoulder; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1283; Expiration date was not reported) on 20Jan2021 (12:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization. Medical history included high blood pressure (HBP); atrial fibrillation (atrial fib.); sleep apnea; heart disease; contrast dye allergy; and mold allergy. Concomitant medications included losartan, carvedilol (COREG) and piroxicam (MAXIDENE). On 22Jan2021 (08:00), the patient had headache; horizonal red line of swelling at the injection site; nausea; and circular rash on the shoulder. The patient did not receive any treatment for all the reported events. The outcome of the events, 'headache', 'horizonal red line of swelling at the injection site', 'nausea' and 'circular rash on the shoulder', was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, and was not tested post-vaccination.

had a feeling like taste liberty; Diarrhea; hemorrhoids; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: unknown) via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetic. Concomitant medications were not reported. The patient stated he took the vaccine shot, Covid 19 and he suddenly got diarrhea, hemorrhoids that was on 22Jan2021 on the Friday. Then he experienced some problem with it, the next day the 23Jan2021 it was Saturday. Again he woke up this morning (on 25Jan2021) which was Monday and had a feeling like taste liberty. Asked if that was probably the side effect or a reaction to be treated. Patient stated blood work but he did not have the records right now. Patient stated he took bismuth subsalicylate (PEPTO BISMOL) and a zinc sulfate (PEPTIN, reported as Kill Peptin). He took bismuth subsalicylate Pepto Bismol. It was for the fluid of the stomach and diarrhea. It was called Pepto Bismol. He did not how to spell it. The events were considered as non-serious. The outcome of events was unknown. Information on the lot/batch number has been requested.

Upset stomach and nausea came on suddenly about 30 minutes after shot. I day later, stomach still upset.

After mild and expected side effects (stomach ache, mild diarrhea, headaches, tiredness) woke up at 2 am with dizziness on rolling over in bed. Persisted into the morning on arising.

ER to bring down temperature and blood pressure; ER to bring down temperature and blood pressure; Stomach cramps; nausea; sever body shakes( uncontrollable); This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 30Jan2021 08:00 at a single dose for covid-19 immunization. Medical history included A-fib. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included apixaban (ELIQUIS), metoprolol, rosuvastatin, furosemide sodium (LASIX) and spironolactone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aspirin [acetylsalicylic acid] but had allergies. On 31Jan2021 02:00 AM, the patient experienced stomach cramps, nausea and severe body shakes (uncontrollable). They had to call 911 and the patient had to be taken to hospital. The adverse events stomach cramps, nausea and severe body shakes (uncontrollable) resulted in doctor or other healthcare professional office/clinic visit and emergency room (ER)/department or urgent care. The patient received treatment for the adverse events and the patient received treatment in the ER to bring down temperature and blood pressure. The reporter considered the events as non-serious. The patient has been tested for COVID-19 since the vaccination, nasal swab (sars-cov-2 test) with the result of negative on 31Jan2021. The outcome of the events stomach cramps, nausea and severe body shakes (uncontrollable) were recovering while the outcome of the other events was unknown. The following information on the batch/lot number has been requested.

Profound fatigue, loss of appetite, continued unabated for 11 days. Still experiencing mild symptoms now, 14 days later.

1st vaccine 2/19/21; developed N/V/D abdominal pain and fatigue 2/20/21; seen in ED 2/23/21 for ongoing symptoms

my father started experiencing mild headache the night after injection (Sunday night). He lost his appetize the following day (Monday). The symptom did not get any better on the second day (Tuesday) after injection, in addition he felt fatigue so he measured his blood pressure and heart rate and noticed that he had higher blood pressure (145/90 versus 130/80 his normal) and much faster heartbeat (110 versus 80 his normal).

2/9 received 2nd vaccine in series. 2/10 mild headache and fatigue. 2/11 worsening headache, extreme fatigue, and general malaise. In bed except for bathroom use and minimal food consumption starting 2/11 until hospitalization on 2/17/2021.

11/24/2021 Began with indigestion, chest discomfort and slight arm pain. then on 11/26/2021 symptoms worsened. Admitted to medical center for cath and stint placement.

Exactly one week following the injection I experienced sudden onset of significant vertigo that required immediate bed rest. There was also minimal nausea and headache, intermittent. Slept well, but had a very difficult time walking from bed to toilet during early morning due to the symptoms. Slightly improved by 7 AM in the morning. Intermittent episodes of the vertigo during Friday and Saturday, decreasing in intensity. Was able to exercise on stationary bike on Friday and Saturday PM. No symptoms Sunday AM (now). Will symptoms recur?

had severe acid reflux; trouble breathing for about 15 minutes; was wheezing and sounded like an asthma attack.; Felt like something was stuck in his throat; He feels tired now; vomited lying down; Right now his throat is burning; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient woke up and had severe acid reflux, trouble breathing for about 15 minutes, couldn't catch his breath, was wheezing and sounded like an asthma attack. He felt like something was stuck in his throat. It cleared in 10 seconds and he could breathe and swallow fine. He took a Benadryl as treatment and drank water. He also felt tired. The patient further reported that he had the covid vaccine shot. He did not know if he was having a reaction, but he was taking a nap, and he guessed he regurgitated. He had a difficult time catching his breath, it was like it was stuck in the throat. He vomited lying down. He felt the stomach acid come up into mouth after he was able to breath better. But before he was not breathing at all. This never happened before. He was lying flat, he guessed he threw up. He had a large lunch, maybe too large. It was like he was getting something caught in in throat. The patient also reported that his throat was burning and mentioned that he slept on a triangular pillow. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.

Patient presented to ED with weakness, black stool and was found to have erosive gastritis with PUD. Multiple polyps on colonoscopy. Per , hospitalizations are to be reported irrespective of attribution to the vaccine. This hospitalization does not appear to be related to the vaccine.

Dizziness and nausea, fever peaking at 101.4 deg, chills lasted for 2 days. Severe muscle aches, strong joint pain, persistent tiredness, bowel irritation lasted for more than 3 weeks so far. Examined by doctor but no treatment prescribed. Rash in right arm was visible on fourth day, below shoulder where second shot was received. Severe pain in left shoulder on third day, where first vaccine shot was received 3 weeks before second shot. Most symptoms are improved at this time, but still some tiredness and muscle and joint pain.

Patient awoke at 01:30 am on 1/31/21 with abdominal cramps, nausea, diarrhea x 3 stools, and chills with rigors. 01/31/2021 03:22 presented to ED for assessment with complaints of abdominal pain and shaking; 01/31/2021 06:29 patient discharged from ED - symptoms resolved; ED Tx consisted of Acetaminophen 1gm IV x 1 dose; chest x- ray (neg); CBC (WBC 12.9); CMP (AST 77, ALT 94); Respiratory Panel 2.1 IVD (BIOFIRE) - Negative; EKG - A-fib rate 108;

Entire core hurt. Loss of appetite. Fatigue. Joint ache. Mild headache. Second day less severe. Third day weakness and fatigue.

chief complaint of lightheadedness and an upset stomach onset this morning. Patient states that yesterday he had his second Pfizer COVID shot. Afterward he felt fine but this morning woke up with an upset stomach, lightheadedness and felt clammy. He describes the upset stomach as feeling hungry. The lightheadedness is described as, "my stomach felt off, which made me feel sick and off". His wife called EMS for the patient to be evaluated as he has a cardiac history. At this time he has no lightheadedness but his stomach is still upset, like "I need to eat". Received pepcid and NS 1000 mL

Receive vaccine at approximately 0855 at off site location. Waited 15 minutes in post vaccination waiting area and left clinic. He drove to medical office at 0920 to report "throat swelling" on the left side that started 10 minutes post vaccination that progressed to bilateral. He reported difficulty swallowing. No respiratory distress. EMS called and he left per EMS at 0928. Attempts to contact later in the day on 3/18 not successful

dehydrated and then he stayed in the hospital for some time; said patient has Covid; severe reaction to the vaccine/severe allergic reaction to the vaccine; high fever/get real hot/running a 103.1; sweating; UTI; could not breathe and he was struggling to breathe; Moaning; diarrhea; chills; shaking all over; severe headache; started throwing up; he was not feeling well; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202 and expiry date: unknown), via an unspecified route of administration on 26Feb2021 16:00 at a single dose for covid-19 immunization. Medical history included asthma and stage 4 kidney disease. The patient's concomitant medications were not reported. On 27Feb2021 (Saturday), patient was not feeling well and on 28Feb2021, he had diarrhea, chills, shaking all over, severe headache and started throwing up. Reporter stated patient had all the symptoms of the reactions and then "you go again to the serious, more dangerous symptoms, he has all of them". Throwing up, fever, chills, diarrhea and then he get real hot and then he started sweating and it was another day on 01Mar2021. On Monday (01Mar2021), reporter called to take patient to the hospital with high fever. The ambulance put him on IV and oxygen right away. They gave him fluids and were monitoring everything because he was dehydrated and then he stayed in the hospital for some time. He had x-rays, they monitored his blood pressure and heart rate, and the doctor was concerned about his heart rate and blood pressure. Doctor decided to check his urine and he did and he had a UTI on 01Mar2021, and so he gave him antibiotics for that (treatment unspecified). Patient seemed to be better after having the fluids and everything so they let him come home. During the night on 01Mar2021, he had another attack and it was the same thing that he had before. The shaking and the chills the fever and throwing up and the doctor said that it was a reaction from having the vaccination and reporter just wanted to report that he did and reported actually thought he was going to die. Reporter tried to call again the ambulance since she thought that he was not going to make it. The doctor put on the report and he did not put on there that he was in there because of suspected of (incomplete sentence) and then told the reporter himself that he had a reaction from the vaccine. The report stated that patient was in for a UT, but the reporter stated that, once does not call an ambulance for a UTI and she (reporter), have UTI's all the time. After the reporter got the patient home, he was even much worse. Patient could not breathe and he was struggling to breathe on 01Mar2021. He was shivering, shaking, having diarrhea, throwing up, soaking wet, and she had to change his clothes twice, and his fever was 103.1 F around 2:00 or 3:00 in the morning of 02Mar2021. The pharmacist gave medicine for vomiting. Reporter called the hospital and the nurses were busy and they could not take it so 24 hour nurse called. She was finally able to get him comfortable enough that she didn't have to call again. She thought she was going lose him. She said she felt twice he was going to die, when she called. At the hospital they told him he was having a severe reaction to the vaccine but also had a UTI and they gave him antibiotics. Patient contacted her nephew who is a medic in the military and RN and he said patient has Covid and thinks reporter has Covid too because the virus was in the vaccine. The nephew explained that patient just could not fight it off and said the vaccine acts like that. It made sense because it is inhibit in it then your body will learn to fight it off, like if you come in contact with it and that makes sense but the woman never explained. The nephew further stated to reported that patient's immune system or whatever was not able to fight it off. So, he said he has to have Covid and when patient heard that after all they had fought to stay away from it and then what were they supposed to do. Patient got the vaccine and ended up with it and that is what reporter have found out and it was very disturbing. Patient was running a 103.1 earlier on the night of 02Mar2021. He was moaning a little bit on Mar2021. Reporter thought patient had severe allergic reaction to the vaccine because he had all the symptoms and stated there was no doubt in her mind (referring to it being an allergic reaction) as it was too soon after the vaccine. Outcome of the event of dehydration was recovering, while for the remaining events was unknown. Reporter was asking if patient should take the second shot.

Patient reported feeling overly fatigued, abdominal pain and elevated liver enzyme results on lab work.

I have experienced light dizziness the first day (3/24) Today (3/25) I am unsure on my feet and have not been able to keep anything on my stomach. At first, I attributed this to a weight management plan that I am on, but late recalled the symptom described in my covid response reporting texts. I Have yet to receive a Covid update text today, so I am submitting this report. I am scheduled to see my PCP tomorrow.

mental fog/bit of fog; foggy; Nausea; very sleepy; tired; Injection site pain/pain to the injection site; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration, administered in the left arm on 19Feb2021 08:40 at a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (Afib) about 10 years ago (2011). Concomitant medication included unspecified medications including blood thinner and Afib medications. The patient takes 6 medications: some of those medications for 40 years, some for a bit less. There were a couple more added for his heart because 10 years ago he had a case of Afib and the doctor who has now retired took him from 3 meds to 6; and has had no issues for the last 10 years. The patient had his first dose on 19Feb2021 at a clinic and was due/scheduled for his second on 12Mar2021. The patient had severe reactions to the first one so he wanted to know if he should accelerate second shot or stay within three weeks. His reaction was for the first two weeks, he had severe nausea, etcetera, which was getting better that week. He gives 20-minute presentations each morning and the participants in the presentation were nice about it but they say that the patient has fog and thought he should see if he should go in sooner as they were worried about him. His only symptoms remaining after two weeks of severe reactions was that he was very sleepy. All that was left was being tired and mentally in a bit of fog (also reported as mental fog). The patient only had pain to the injection site for a day and was not an issue, then it didn't take long for him to start getting extremely tired and have nausea. He says all he knows was that from the sheet listing severe reactions, he had every one during the first couple weeks (unspecified), though he never had a fever. He says this week he felt better and he was starting to eat, this was not normal for him to be tired all the time, but at least he was not sick. He says he didn't treat the pain or nausea, because he was healthy as a horse, and has no problems with a vaccine, shots don't bother him other than having soreness the first day. The patient was just foggy and tired. The patient was recovering from nausea. The patient recovered from injection site pain on 20Feb2021. The patient has not recovered from mental fog/bit of fog and tired. The outcome of the remaining events was unknown. Information on the lot/batch number has been requested.

Patient received a vaccine at museum sight on 03/23/2021 at 0130 pm according to fiancé. Around 1:30 the next day, his fiance tried to call him and she stated that his voice was garbled, she found him face down with his chin on the table, covered with his own feces and urine. EMS notes that upon their arrival the pt had a right sided facial droop along with some contracture to his left side. Pt was originally awake and confused as he gradually became unresponsive and is only responsive to pain of sternal rub. He has no history of stroke. Pt's BP was noted to be 88/50's en route.

fever and was hospitalized with gastrointestinal bleeding.; fever and was hospitalized with gastrointestinal bleeding.; abdominal pain; vomiting with blood; This is a spontaneous report from a non-contactable consumer. A 77-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot: unknown), via an unspecified route of administration on 26Feb2021 at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination. The patient's medical history was not reported. Concomitant medication included dabigatran etexilate mesilate (PRADAXA) taken for a year. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot: unknown) on 05Feb2021 for COVID-19 immunisation. On 09Mar2021, the patient experienced fever and was hospitalized with gastrointestinal bleeding, abdominal pain, and vomiting with blood. The events caused hospitalization on an unspecified date. It was reported that patient had COVID test post vaccination on 10Mar2021 with unknown results. Therapeutic measures were taken as a result of all events. The outcome of all events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

diarrhea; COVID shot made the diarrhea worse.; This is a spontaneous report from a contactable consumer. A 78-Year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 27Jan2021 (Batch/Lot number: Unknown) as single dose for covid-19 immunisation, hyaluronic acid (GEL ONE), via an unspecified route of administration from 21Jan2021 (Batch/Lot number: Unknown) at 2 DF (he got two shots in his knees) for his bones.The patient medical history was not reported. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication. In Jan2021 the patient experinced diarrhea and In Jan2021 the patient stated covid shot made the diarrhea worse. It was reported that he later added that he got two gel shots, clarified as, Gil 1, he got two shots in his knees on 21Jan2021. After he got these shots in his knees he a little diarrhea about 3-4 days after that. He got the shots in his knees for his bones. He then got the shot, the COVID shot on 27Jan2021 and he thinks the COVID shot made the diarrhea worse. He reinforced he does not go like 5-6 times a day. However, sometimes it is twice a day and it is loose. It is a lot worse than before, not normal. He stated he only took one Tylenol before the shot and now it's out saying should not take it before the COVID shot. He stated they have not taken any Tylenol since the COVID shot. The outcome of the event diarrhea was not recovered and outcome of the other event was unknown. Information on the lot/batch number has been requested.

Patient has been experiencing metallic taste, tongue feeling like sandpaper, and upset stomach. Patient still has upset stomach but the metallic taste has disappeared and the tongue feeling like sandpaper is not as severe as it was initially. Patient has tried Prilosec to relieve upset stomach with no relief and has contacted MD with no new orders. Suggested for patient to take Mylanta, will follow up on 4/4/21. Patient feeling much better, has taken Mylanta as requested, no longer has upset stomach.

Received first vaccine 11 FEB 2021: Initially had no issues. On 01 Mar 2021, felt myalgias and fatigue with temperature up to 99.2F and patient insists his basal core temp is 97.5F. Received his second vaccine on 04 Mar 2021 with temp < 100F therefore staff encouraged him that he had no contraindication. Same day, noted aches, pains, N/V, decreased appetite, loss of taste. Subsequently noted increased temperature up to 100.4F (single true fever) on 09 Mar 2021. Developed cough on 13 Mar 2021. His remaining symptoms are fatigue, loss of taste, decreased energy. The patient also noticed acute onset Rt chest wall pain after an episode of coughing ? states that it feels like a similar episode previously with known prior Dx of rib fracture. Not worse with exertion or relieved by rest. Not associated with meals. Worse with contact and position changes. He is taking ASA-325, 2 tabs each morning for pain, then 2 x 200mg Motrin tablets at night.

weakness; diarrhea; Dizziness; Really Bad Tiredness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at 77-year-old on 11Mar2021 12:00 (lot number: EN6199) at single dose for COVID-19 immunization. Vaccine was received in pharmacy, not at military facility. The patient medical history was reported as none. Family medical history relevant to the events was none. The patient's concomitant medications were not reported. No history of all previous immunization with the BNT162B2 considered as suspect. No additional vaccines were administered on same date of BNT162B2. No other products. No prior vaccinations within 4 weeks. No events following prior vaccinations. The patient experienced diarrhea (hospitalization) on 18Mar2021, weakness (hospitalization) on 22Mar2021, swollen lymph nodes on 18Mar2021, really bad tiredness on 19Mar2021, dizziness on 26Mar2021. Dizziness occurred when he stood up. The patient was hospitalized for diarrhea and weakness from 22Mar2021 to 24Mar2021. The patient was getting weak and they got worried and went to the ER (Emergency Room); he was admitted on 22Mar2021, observed on 23Mar2021 and came out on 24Mar2021. He was "Out of It" and on that Monday he was feeling so tired and weak and he had problems all last year and they were alarmed so they went to be checked out and the patient was released without finding anything. The events resulted in emergency room visit on 22Mar2021. No visit to physician office. Therapeutic measures were taken as a result of events included loperamide hydrochloride (IMODIUM). The outcome of events diarrhea, weakness, swollen lymph nodes, really bad tiredness was recovering, outcome of event dizziness was recovered on 26Mar2021. No medications, medical conditions, or tests relevant to this report. Consumer mentioned that the patient has an appointment to get the second dose of the BNT162B2 on 01Apr2021 and wanted to know if there were reports about getting the second dose will make the side effects stronger.

weight loss; no appetite; breathing is shallow; low oxygen 89%; muscle aches; imbalanced; can't sleep; blood pressure down/128/68/and 132/76; weird dreams; minimal injection site pain; This is a spontaneous report from a contactable pharmacist. A 77-years-old male 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 13Feb2021 17:15 (Batch/Lot Number: EL9209) as single dose for covid-19 immunisation. patient medical history about 20 years ago for a torn ACL and also general surgery. Concomitant medication(s) included levothyroxine taken 100 ug once a day for an unspecified indication from 2018 and ongoing; atorvastatin (LIPITOR) oral 100 mg, once a day taken for blood cholesterol increased from an unspecified start date and ongoing and vitamins Cs and Bs as supplements. The patient experienced minimal injection site pain on 14Feb2021, can't sleep, blood pressure down 128/68/and 132/76, no appetite, breathing is shallow, muscle aches, imbalanced, low oxygen 89% and weird dreams on 26Mar2021. weight loss on 27Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021, body temperature: 98.3 on 26Mar2021, oxygen saturation: 89 % on 26Mar2021, blood pressure measurement: 132/76 on 28Mar2021, body temperature: 98.3 on 28Mar2021 and oxygen saturation: 95-96 % on 28Mar2021, body temperature: 100.8 on an unspecified date and oxygen saturation: 96 % on 29Mar2021. The report considered as a serious. The outcome of the events can't sleep , weight loss, no appetite, breathing is shallow, muscle aches, imbalanced and weird dreams was reported as not recovered, minimal injection site pain was reported as recovered as 15Feb2021 . blood pressure down/128/68/and 132/76 and low oxygen 89% was reported as recovering,; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the reported events cannot be completely excluded. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.

Timeline of events: o No concerns in the past month. o Usual state of health on Friday 4/9/2021 o Received Pfizer vaccine at event on 4/9/2021 o Fatigue, poor PO intake and myalgia on Saturday, 4/10/2021; Received Tylenol at 1 pm o Texted Primary Community Nurse (PCN) (not on call), on Saturday, to share above. PCN followed up Sunday morning and reassured them. o Last seen alive Sunday night, not well from vaccine but does not seem like family was concerned enough to page on call team o Monday morning- found dead in rigor mortis o Cause of death: deemed sudden cardiac death. Etiology unclear. o Unexpected death.

The patient was admitted to hospital from 2/24/2021 until 3/6/2021 for AMS, diagnosed with UTI. He had an MRI on 3/3/2021 that incidentally showed a nonocclusive thrombus in the right dural venous sigmoid sinus, which extends to the right jugular vein. He is being treated with apixaban. It is unclear if this is coincidental or somehow related to the vaccine.

Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 76 and presented to the ER on 2/20/21 with altered mental status, weakness, and persistent diarrhea after just being discharged previous week for bacteremia. Hospital progression included a GI bleed requiring blood transfusions, esophageal varices, and unrecoverable mental status. Care was transitioned to hospice where he passed on 2/28/21. Comorbidities include cirrhosis, CKD, DM, pancytopenia, frequent paracentesis for ascites.

loss of balance; Headache; Fatigue; dizziness; nausea; pain in muscles all over body; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6201, expiry date is not reported) via an unspecified route of administration, in Arm Left, on 18-FEB-2021 07:00 AM (at age of 77 years), as a single dose for COVID-19 immunisation. The Patient's medical history included Benign nerve-sheath tumor, not growing. Concomitant medications included Atorvastatin, Tamsulosin, Pepcid, Allegra. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3247, expiry date is not reported) via an unspecified route of administration, in Arm Left, on 26-JAN-2021 07:30 AM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received Atorvastatin, Tamsulosin, Pepcid, Allegra within 2 weeks of vaccination. 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 had experienced Headache, fatigue, loss of balance, dizziness, nausea, pain in muscles all over body on 18Feb2021 08:00 PM. Patient didn't receive any treatment for the event. Outcome of the event was reported as Recovered/Resolved with Sequel.

Death Narrative: Patient was admitted to facility from 1/11/2021 to 1/13/2021 for treatment of Covid 19 with symptoms of fatigue and poor oral intake. Admission was uneventful and follow-up notes post discharge from both Cardiology APRN and Primary Care Physician that the Patient was recovering well post admission. Patient received first of Covid Pfizer Vaccine on 4/2/2021 and second dose of Covid Pfizer Vaccine on 4/22/2021. Patient had been observed for 15 minutes after administration of each dose. No reaction was noted during the post vaccination observation period of either dose. Notice of death was received 5 days after second dose of Covid Vaccine from funeral home. There were no reports of an ADR occurring between observation period and death. There were no progress notes in patients chart between second Covid 19 Vaccine note 4/22/201 and death notice 4/27/2021. Cause of death is unknown at this time.

It started with stills, nausea, aches for about 24 hours. Then more and more trouble breathing for 8 weeks. In the past week it has been somewhat better.

No energy; no appetite; hot & cold; body aches; Very hoarse; coughing; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 14Jan2021 at 12:45 as single dose for COVID-19 immunization. Medical history was not reported. Patient had no known allergies. Concomitant medications included ezetimibe, tamsulosin, amlodipine, sumatriptan, finasteride and tadalafil. 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. On 16Jan2021 at 01:00 PM, patient experienced no energy, no appetite, hot & cold, body aches. very hoarse, coughing-No fever. On 25Jan2021, the patient was tested negative for COVID-19 via nasal swab. No treatment was received for the adverse events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Vomiting for 3 days, terrible splitting head ache, ear ringing, disoriented, confused. bed ridden for 5, heard things not there unable to eat.

12 hours after vaccine became very nauseous and achy. In bed and very ill for 18 hours. Had Covid in March of 2020. Should never have gotten the vaccine as I still had antibodies.

Pt with history of recovered Covid, developed sudden absominal pain, distention, emesis, diagnosed with bowel infarct and pneumonia, one day after 1st covid vaccine. Died 1/5/21 in hospice.

COVID-19 Chills Nasal congestion PND (post-nasal drip) Acute nonintractable headache, unspecified headache type Diarrhea 05/06/2021 03:54 PM EDT Phone (Outgoing) COVID 19 MAB Infusion Navigator Initial Patient Assessment Ordering Prescriber has completed required FDA EUA elements. COVID-19 Positive Result Date (and on chart/file):05/06/2021 Start of Symptoms Date: 04/29/2021 Meets Criteria: ANY AGE: ? Body mass index (BMI) ?35 ? Chronic kidney disease ? Diabetes ? Immunosuppressive disease AGE SPECIFIC: ? ? 65 years of age ? ?55 years of age AND had Cardiovascular Disease OR Hypertension OR COPD/other chronic respiratory disease Reviewed present symptoms with patient. Congestion, diarrhea Purpose of Infusion Assessment: Can you tell me why you are receiving this infusion? Reviewed by Physician 1. Date/Time of Infusion: 5/7/21 @12:00. Location of Infusion: Come to unlisted address. Park in the parking lot next to the Medical Office Building, and while in your car, contact the Infusion Center to register over the phone from your vehicle. Once you are registered, you will be directed to the entrance and a nurse will be down to meet and assist you to the suite and infusion room. 2. Confirmed that patient has spoken with his PCP/Referring Physician, patient is in agreement to the MAB infusion and acknowledges understanding and denies any additional questions at this time. 3. Confirmed that the demographics in the chart are correct including phone numbers, address and health insurance. 4. Patient will utilize a thermometer and pulse ox. Explained to patient about collecting temperature and pulse ox daily for 10 days. If applicable, patient will receive any additional assistance with their website access & use by the infusion clinic clinical team. 5. Patient will receive a ride to the appointment if needed. Patient first emergency contact and decision maker is unlisted. 6. SDOH ASSESSED. Key Reminders: You will want to eat or drink like you normally would prior to coming for your infusion. You can also take your medications as you would normally do, unless your physician has told you specifically not to take something.

Patient presents to the ED on 4/23 with complaints of dizziness described as presyncopal episodes happening twice that day. Felt lightheaded early in the day. Patient noticed his stool was dark black colored the last 2 days, no prior history of GI bleed. Patient is not on anticoagulation therapy currently, is taking fish oil and acetaminophen. INR is at 1.2 upon admission. Patient diagnosed with severe diverticulitis, patient was operated on to remove polyps, no source located for GI bleed. Patient was treated for anemia and discharged after 6 days.

Awoke at 5 AM with extreme nausea and went to bathroom to vomit. Passed out, hitting chin on toilet bowl and chipping front tooth. After vomiting, laid on floor for 2.5 hours before gaining enough strength to return to bed. Slept for the next 24 hours. Unusual fatigue still present daily.

tiredness; fever of 101; had the runs; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old male patient received BNT162B2, (COMIRNATY, solution for injection, lot# EN6206) via an unspecified route of administration, administered on left arm on 09Mar2021 as 1ST dose, single dose for covid-19 immunization. The patient medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine ab-normalities (including diabetes) and obesity, COVID virus in October 2020. The concomitant medications were not reported. Symptoms came on right at the same time, he had second Pfizer Covid vaccine at 10:40 in the morning and by 17:00 in the evening had the reactions. The patient experienced headache on 09Mar2021 15:00, on 10 Mar 2021 woke up about 8:30 and he had all the symptoms start right after that. Tiredness on 10Mar2021, fever of 101 on 10Mar2021, had the runs on 10Mar2021. Outcome of headache tiredness, fever (fever of 101) and had the runs recovered on 11Mar2021. No follow-up attempts are needed. No further information is expected.

Pt w/no significant PMH p/w worsening symptoms over 10 days of cough, general malaise, nausea, poor oral intake, and sore throat. On admission, was hypoxic on RA & generally ill appearing. CXR showed poss viral pneumonia consistent w/COVID-19 and COVID test was positive despite having received Pfizer vaccine on 01/15 & 2/8/21. Was admitted for acute hypoxic resp failure secondary to COVID and given 3L O2, dexamethasone and remdesivir. Was ultimately discharged 3 days later w/follow-up.

Liquid Diarrhea, 2 times. A lot of liquid and smelley; This is a spontaneous report from a contactable male consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6206, Expiration date: not reported), via unspecified route, administered in left arm on 09Mar2021 02:00 PM as 1st DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medication included valproate semisodium (DIVALPROEX) DR 500 mg and 750 mg, Rosuvastatin10 mg in two weeks of vaccination. The patient previously took glyceryl trinitrate (NITROGLYCERIN) and had allergies to it. Patient was not tested positive for covid prior of post vaccination. On 10Mar2021 07:30 am, after the vaccination, the patient experienced Liquid Diarrhoea, 2 times. A lot of liquid and smelly. Imodium was taken as treatment option. Patient had not tested positive post vaccination. The outcome of the was not recovered No follow-up attempts possible. No further information expected.

Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EL3247), via an unspecified route of administration in right arm on 02Feb2021 at 00:00 (at the age of 77-years-old), and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6200), via an unspecified route of administration in right arm on 25Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history included IBS, diabetes insipidus, gastroesophageal reflux disease (GERD), osteoarthritis, hypertension and high cholesterol on an unknown date. Concomitant medications were not reported. 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 have any allergies to medications, food or other products. The patient did not receive any other medications within two weeks of vaccination. On 02Feb2021, the patient experienced diarrhea lasting from first dose to current date 18Mar2021 which was uncontrolled by budesmide. The patient had undergone treatment with budesmide for diarrhea. The outcome of the event diarrhea was not recovered at the time of reporting and had resulted in Doctor or other healthcare professional office/clinic visit. No follow-up attempts are needed. No further information is expected.

spiking of his blood pressure; sore arm; legs swollen; pain on one leg; on and off nausea; not feeling right; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 24Feb2021 (Lot number was not reported) at the age of 77 years, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2, dose 1 on unspecified date for COVID-19 immunization. On an unspecified date the patient experienced spiking of his blood pressure, sore arm, legs swollen, pain on one leg, on and off nausea, not feeling right. The patient had lab tests and procedures which included blood pressure measurement: 190/80. The clinical outcome of the events was unknown. The clinical course was reported as follows: 77-year-old caller reported receiving his second dose of the Pfizer-BioNTech COVID-19 vaccine 24Feb2021 and experienced a "sore arm" after. He explained that a week after vaccination, on the Monday, he " woke up with his legs swollen and pain on one leg". He stated he also experienced spiking of his blood pressure (BP), however on Monday 03Mar2021 he went to the ER since his BP rose over 190/80. He explained at the ER, he guessed they got him more call, and he received a prescription of "water pills" to take for "a couple weeks". He added then, there were moments when he "didn't feel right". He specified he would be "good" in the morning then he "just didn't feel right" in the afternoon. He reported about a month later, 13Apr2021 he had a "second incident with the spiking" of his BP, which led him to the ER. He explained his cardiologist then changed his amlodipine prescription to "5mg in the morning and 5mg at night". He explained he would take 1 pill of Amlodipine 10mg in the morning before vaccination. He added he would take 5mg of amlodipine for a year before being increased to that 10mg a day. He explained before vaccination, he "never experienced such spiking with his BP and considers himself healthy for his age. DSU agent reported his BP is generally around 120/70 and he routinely use the treadmill. He mentioned he now seems ok, has not have a "violent" BP spike, but has "not felt 100%" yet. He added some days he is "fine" and others he has "on and off nausea" or he "feels his legs are swollen in the evening". The main reason for his call is to see if Pfizer have any experience with people who have covid, the long haulers, with the effects for quite a while, that are 3 months in. He was wondering whether or not any long hauler folks that have had on and off side effects attributed it to the vaccine. Information about Lot Batch number has been requested.

4th day after dose 2, pain under right side ribs, as days progressed, pain circled around back to right side. severally limited mobility. lasted about 8 days, then tapered down to much milder pain.; 4th day after dose 2, pain under right side ribs, as days progressed, pain circled around back to right side. severally limited mobility. lasted about 8 days, then tapered down to much milder pain.; circled around back to right side. severally limited mobility. lasted about 8 days, then tapered down to much milder pain.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3249), via an unspecified route of administration, administered in Left arm on 26Jan2021 13:00 at the age of 77-years-old as 2nd dose, single dose for covid-19 immunisation. Medical history included CHF (Congestive heart failure) from an unknown date and unknown if ongoing, PE (pulmonary embolism) from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included unspecified medication, Allioyrubikm; Dabigatran (DABIGATRAN) taken for an unspecified indication, metoprolol (METOPROLOL) taken for an unspecified indication, spironolactone (SPIRONOLACTONE) taken for an unspecified indication on unspecified date received in two weeks of vaccination. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK5730), via an unspecified route of administration, administered in Left arm on 05Jan2021 at 13:00 as single dose for covid-19 immunisation. The patient did not receive other vaccine in four weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient has not been tested for COVID-19 post vaccination. Covid test post vaccination was no. On 29Jan2021 at 06:00, 4th day after dose 2 the patient experienced pain under right side ribs, as days progressed, pain circled around back to right side. severally limited mobility. lasted about 8 days, then tapered down to much milder pain. still have pain 10 days after dose 2. No treatment was received for adverse events. The outcome of event, mobility decreased was unknown and for other events was not recovered. Follow-up (07MAY2021): Follow-up attempts completed. No further information expected.

Night of first injection my dad said he missed his bed and fell on the floor and laid in the floor and couldn?t move for an hour. The day after second injection he almost passed out and we went to the ER. He was sent back home. Now he has been diagnosed with Parkinson?s disease. He has low Vitamin D. He is anemic and his iron is so low he is receiving 2 iron infusions. He has blood that has showed up in his stool and is having a colonoscopy on July 15th. He stays very dizzy and weak. He also has problems now with his eyesight.

Visit summaries/notes attached on below visits 3/25/2021 ER with chest pain, worse with deep breath; diagnosis costochondritis 4/14/2021 ER with chest pain, painful breathing, wheezing, weakness, fever (101.3 rectal). 4 pound weight gain overnight. Differential diagnoses costochondritis, pleurisy, pneumonia, COVID-19; admitted to hospital.Discharged 4/16. 4/25/2021 admitted to hospital; chest pain, shortness of breath, weakness, bloat, inflammation markers high, mild pericardial effusion, near syncope.

Was currently w/hospice care. 5/25/2021 exhibited symptoms nausea/emesis. Seen by MD. Treated for symptoms. continued to decline consistent w/ dx. End of life care with nitro prn, oxygen continued and emotional support followed and he expired 5/27/2021 at facility.

Hospitalization, Dizzy, lightheadness, nausea, and vomiting Body part and time not know for vaccine Covid Tested on 7/14/2021 tested positive Patient is currently in hospital

Hives; Bruising; Fever of 102, almost 103; GI problems; This is a spontaneous report from a contactable consumer (patient). This 77-year-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 05Mar2021 18:00 (Batch/Lot number was not reported) (at the age of 77-year-old) as dose 2, single for covid-19 immunisation. Medical history included blood pressure abnormal (was taking blood pressure medications to bring it normal), hard of hearing with hearing aids. Concomitant medication(s) included Losartan taken for blood pressure. Patient received first dose of BNT162B2 on 10Feb2021 06:00 PM (Lot number: EL3247). Patient was reporting a possible side effect from the Pfizer COVID shot in March. Around 02Apr2021 patient had hives, the broke out and he went to different doctor, dermatologist, the allergist, regular doctor. He was in the hospital for 3 days because the hives were actually pretty bad to the point where they were bruising and the blood vessels were 'worsening' from the top of head to the sole to feet, every part of the body. Now patient tried 3 times to get rid of them by using Prednisone given by doctor and the antihistamines. As soon as go off to Prednisone the hives come back and retrieved. Patient did all kind of test for that and never find what's causing the problem, doctors couldn't find the cause of hives. The only thing they point to, is the fact that the month patient had the vaccine shot that developed this, 3 times. Patient got the both shots the first and the second shots and after the second shot, the day after he developed fever of 102, almost 103 and that pretty well went away, they said that could happen and that did. It went away after one day and he was fine, then this other stuff started later. Patient was experiencing lot of GI problems, he thought this is due to COVID shot. Treatment included Prednisone, Antihistamine (Unspecified Medication) as well Allegra, Zyrtec and Benadryl. when he was on prednisone, the hives went away. When off Prednisone they came right back. When went down to lower doses, they came right back again. He was not taking Prednisone anymore. The outcome of Fever was recovered, of other events was not recovered. Information on lot/batch number has been requested.

Patient got the vaccine around 9:15am and around 1pm he was experiencing chills, sweats, fatigue and started vomiting and vomit was yellow in color. 911 was called and he was taken to the hospital. Nursing home staff notified us that patient did not eat anything that day and nothing 1am the day prior.

moderate diarrhea and intestinal discomfort. more than 4-5 prolonged bowel events in a 24hr period fully recovered 24 hours later

Stated since Xmas he has not feeling well after a family gathering. His wife in hospital for Covid-19 pneumonia. He reports for about 1 week, his SOB worsen, not eating well at all for the past 3 days. Which prompt him to visit the ED. Admitted to Hopital for Dehydration; Dyspnea; Pneumonia due to COVID-19 virus; COVID+ 1/10/21; still admitted

Nausea; Tiredness; Feeling Unwell; This is a spontaneous report from a contactable consumer reporting for himself. A 78-year-old male patient received bnt162b2 (BNT162B2, lot number and expiry date were unknown), on 15Jan2021 at 09:15 AM on the right arm for COVID-19 immunization. The vaccine was administered at a living facility. The patient had not received other vaccines in four weeks prior to receiving bnt162b2. Medical history was not reported. He had no known allergies. Concomitant medications included unspecified medications (other medications in two weeks: yes). The patient did not have covid prior to vaccination and was not tested for covid post vaccination. The patient experienced nausea, tiredness and feeling unwell on 16Jan2021 10:00 AM. The patient did not receive any treatment for the reported adverse events. Outcome of the events was recovering. Information on the Lot/Batch number has been requested.

nauseated; vomited; This is a spontaneous report from a contactable nurse. A 78-year-old male patient (reporter's husband) received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in the right arm on an unspecified date at a single dose for COVID-19 immunization. Medical history included dialysis from an unknown date (also reported as started about two years ago). There were no concomitant medications. The patient got real nauseated and vomited, states he got sick last night on 18Jan2021 and today it was much improved. Outcome of the events was recovering.

brainfuzz headache; Aches; woke up nauseous; wobbly Almost fell over twice. Had to steady self; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 19Jan2021 at 11:15 (at the age of 78-years-old) as a single dose for COVID-19 immunization. Medical history included prostatitis, high blood pressure, and high cholesterol, all from unknown dates and unknown if ongoing. The patient previously had COVID-19 prior to the vaccination on an unknown date to an unknown date (not ongoing). The patient did not have any allergies to medications, food, or other products. Since the vaccination, the patient had not been tested for COVID-19. The patient was taking unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jan2021 at 07:45, the patient experienced brainfuzz headache, aches, woke up nauseous, and wobbly (almost fell over twice and had to steady himself). The patient did not receive any treatment for the events. The clinical outcomes of brainfuzz headache, aches, nausea, and wobbly, were recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Fever with Tmax=102.4 F on Day 1 post-vaccination. Fever persisted for ~24 hours, but has since improved and patient has remained afebrile. Loss of appetite starting Day 1 post-vaccination, which lasted for ~2 days.

1042 wife enters building to report pt lost consciousness. RNs responded and found pt awake and alert. RNs dialing 911 and pt and wife refused ambulance or trip to ED. Pt and wife states this happens to him if he walks too far when it is cold outside. Pt states he has heart rhythm issues and sees PCP. Pt was nauseated. Again refused transport to ED. BP @ 1049 144/82, HR 89 and regular. Pt and wife insist he is fine and desire to leave. Pt in drivers seat of car. RNs encourage wife to drive if they are to leave. Pt and wife refuse, and they left with husband driving.

After receiving injection, waited 30 mins before leaving hospital, when walking to car experienced shortness of breath like I'd run a mile. Breathing so heavily, when I got to car, had to wait 5 mins before I caught my breath. Stopped for errand & had same experience. No other symptoms until next night at 012:15 on 01/24/21 when i woke with shortness of breath, clammy, nausea, heart skipping beats, BP 178/106. Went to ER. Had EKG, check xray,troponin levels checked 6 hrs apart. All were negative. Released. Since that time, I continue to have: chills, no temp, shortness of breath, fatigue, mild headache, sore throat, runny nose, occasional nausea. Went for Covid test 02/04/21 Results were negative. Just began feeling more normal today--2 weeks after innoculation.

Feeling sick, muscle soreness, chills, trembling and loss of muscular control, fever, headache, nausea, hyperglycemia, uncontrollable diarrhea, polyuria, insomnia. Event lasted 32 hours. Slept 16 hours of that time, interrupted 11 times due to polyuria and diarrhea. Lost 5 lbs. Have not felt this sick in at least 20 years - not for any bout of influenza, But it only lasted a day. Took no medication including ibuprofen or acetaminophen. Completely recovered

Edema of glottis; General malaise / indisposition; nausea; dizziness; body pain; pain in the joints; swelling of the throat; high pressure; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: El9263) solution for injection, via an unspecified route of administration in left arm on 23Jan2021 09:15 at a single dose for Covid-19 immunization. Medical history included high blood pressure, and diabetes. Concomitant medications included losartan, metformin, and simvastatin. The patient experienced edema of glottis, general malaise, nausea, dizziness, body pain, pain in the joints, indisposition, swelling of the throat, and high pressure; all on 24Jan2021 21:00. Patient visited the physician and received treatment for the adverse events (general examination). The patient was not diagnosed with Covid-19 prior to vaccination. Patient has not been tested for Covid-19 since the vaccination. Outcome of the events was recovering. No follow-up activities are needed. Information regarding the batch/lot number has been obtained. No further information is expected.

Pt received vaccine on 1 Feb and presented to the ED on 3 Feb with Abdominal pain, epigastric; Acute pancreatitis without infection or necrosis, unspecified pancreatitis type; Hypertension, unspecified type; SOB (shortness of breath). He was discharged on 6 Feb 2021

He was bleeding, it came out from his rectum through feces; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581), via unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization. The relevant medical history included gout. Concomitant medications included colchicine for gout and a lot of unspecified medications. The patient took a COVID vaccine yesterday and this morning he was bleeding through the 'raw', it came out from his rectum through feces on 07Feb2021. He stated that the next shot was between 27Feb and 19Mar (Clarification unknown). So it was one day between those two days. He said he still was just a little bit, not like he was. No treatment was received for the event. The outcome of the event was recovering.

First dose given 01/21/21, 2nd dose February 11th 1:30 pm Both first and second dose, first dose only soreness at injection site, second dose had soreness, nausea, cramps in stomach, wheezing, fatigued, chills, vomiting,, diarrhea Symptoms have mostly subsided, just a little stomach craming and fatigue

Flushed, nauseous, serious headache and extremely tired within first hour after receiving the injection. took 2 Ibuprofen and laid down. Ate supper with the family, headache still really bad. Stepped outside for a few minutes and my heart began to race wildly. Called hospital after I couldn't get it to calm down with breathing technique after trying for 40 minutes. Too many bpm for me to count myself.

3 days after the first Pfizer COVID vaccination, the patient had nausea, vomiting, dizziness, hearing loss and loss of equilibrium. These symptoms slowly resolved, but recurred 3 days after the second dose of the Pfizer COVID vaccine.

Severe abdominal cramps/abdominal cramping; Drowsiness; I had a sore shoulder and fatigue; I had a sore shoulder and fatigue; pain; anxiety; small bowel blockage/He had an intestinal blockage; His peristalsis shut down.; bowels are very irritated; He feels bruised; his guts just feel bruised; His blood pressure actually was low while in hospital; Glucose levels were very high while in hospital/when in pain and anxiety his sugar goes up; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number: EL3248) injection to upper left arm just below shoulder at approximately on 29Jan2021 10:00 at age of 78 years old at single dose for vaccination. There were no additional vaccines administered on same date of the Pfizer suspect. Relevant medical history included: for ongoing asthma and adult onset maybe 25-28 years ago. He did not have when he was a kid. He did not have allergies. Part of problem was lives in an area that had a very high allergy problem; a lot of people in that area have allergies; for sleep apnea, used CPAP machine; for diabetes from 2006 and onset date approximate. A1C is where doctors want it to be. Went through half a dozen pills and stuff for diabetes that worked for short time and stopped: Names/Lots/NDCs/Expiries: Unknown, does not have this information to provide. He was pretty good at judging carbohydrate content in meals to make adjustments to Humalog and Toujeo dosing as needed; for ongoing overweight, weight gain started after oral injectable product for diabetes stopped working, he went on different insulin product and gained 30-35 lbs. Oral injectable product: name/lot/NDC /expiry: Unknown, does not have product or this information to provide. Different insulin product: Name/Lot/NDC/Expiry: Unknown, does not have product or this information to provide; modestly high blood pressure; history of intestinal blockages (occurred quite some time ago, no continuing); had operations in the past. The adverse events (AEs) following prior vaccinations: Adverse Event: He was pretty sure he hit the floor before the needle was even out of his arm when he was administered gamma globulin vaccine which he thinks was around year 1972. The company he worked for at the time had a hepatitis break out, a couple of employees had hepatitis, so they had him receive the gamma globulin vaccine. Vaccine/Brand Name: Gamma globulin vaccine/brand name unknown, whatever it was that was available for hepatitis at the time which he thinks would have been 1972. He is pretty sure in those days they used horse serum in the gamma globulin vaccine; the doctors at the time felt pretty sure that the reaction was to the horse serum aspect of the gamma globulin vaccine. Lot/NDC/Expiry: Unknown, he does not have product or this information to provide. Vaccination Date: Thinks would have been in 1972, further details unknown. Patient's Medical History (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: All relevant information documented in formal fields of other conditions. Family Medical History Relevant to AE(s) was reported as none. There was no 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). There were not any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. He was supposed to have the Shingrix vaccine but decided to hold off on that until after he got the Pfizer COVID-19 Vaccine. He had the Flu vaccine around Sep2020 or Oct2020 when the senior version came out. Ongoing Concomitant medications included: losartan 100mg daily from 2019 for high blood pressure, furosemide (LASIX) 20mg daily from 2019 for high blood pressure causing some fluid buildup, fenofibrate 134mg daily for years for triglycerides, finasteride 5mg daily for years for benign prostatic hyperplasia, multivitamins, boosters of other vitamins (advised by PCP since COVID pandemic started), insulin lispro (HUMALOG) fast acting insulin taken as needed for diabetes, insulin glargine (TOUJEO) slow acting insulin taken as needed for diabetes. It was reported patient stated, he had his first dose of the Pfizer vaccine a week ago Friday 29Jan2021 at 10am. He had a sore shoulder and fatigue. At midnight he suffered abdominal cramping by 7am. He took himself to the ER and called his doctor who met him there. He had an intestinal blockage. His peristalsis shut down. He spent a couple days on an NG tube, had x-rays and imaging study, they found a small bowel blockage. It seemed very coincidental within 18 hours of the vaccine. He had them when he was younger. His physician who was an GI specialist said he had 2-3 other patients with similar reactions. He spoke to the safety team regarding this. He was due for his 2nd vaccine a few weeks. Right now his bowels were very irritated, not consistent to bowel movements. He was still on a low fiber diet. Asked if there was any evidence people are having gastrointestinal reaction. He had had blockages in the past, that was his weakness. Asked what to do about 2nd dose. He had asthma, diabetes type 2, mildly hypertensive. This consumer had his first dose of Pfizer COVID-19 Vaccine 29Jan2021 at approximately 10:00. On 29Jan2021 at about 23:30, he had went through usual drowsiness and took a nap. Around midnight 00:00 30Jan2021 he started having abdominal cramps that became very severe. He was taken to the Emergency Room where he was admitted to the hospital from 30Jan2021 until discharged home evening of 03Feb2021. Severe abdominal cramps: His peristalsis stopped, just shut down. As a result he had an intestinal blockage. He had nasogastric tube placed for 4 days. He was scheduled for surgery with a gastrointestinal surgeon who he happens to know personally. He had called that gastrointestinal surgeon before he was admitted to the hospital. The gastrointestinal surgeon thought he heard some sounds, so he delayed the surgery. That night the intestinal blockage broke up. He was discharged from the hospital before they normally would have released him to get people out as quickly as possible due to risk of contagion in hospitals. Both he and the gastrointestinal surgeon are very concerned about him having the second dose of Pfizer COVID-19 Vaccine as scheduled which is due in like 1.5 weeks. The plan at this time is for him to go on a liquid diet 2 days before the second dose so that there is nothing in him to create intestinal block. Outcomes of events: Bowel movements are irregular because just starting to get back into eating really for a few days. The first few days home he was on a soft diet of basically jell-o pudding and broths. He is on an ultra-low fiber diet right now so it's a different diet than he is accustomed to. Some of what he is eating goes right through, other times there is no bulk to come out; he kind of feels like he is constipated but it is just that there is nothing there. Doctor later this week will determine how much he can normalize his diet. Metamucil which a lot of diabetics do, doctor did not want him to take that until everything settles down. He feels bruised; his guts just feel bruised; he thinks from just the pressure there and getting in and out of the hospital bed was horrible. When he called doctor before he went to the hospital 30Jan2021, doctor told him this is coincidence, that this patient was the third that he has had who in 24 hours has had significant intestinal or bowel reaction; that he is not the first who has dealt with severe gastrointestinal problems following the Pfizer COVID-19 Vaccine. Caller clarified he has no first hand knowledge of those other patients/events/products, this was just mentioned to him by the doctor over the phone. He had no further information to provide for this report; but doctor might be able to provide further information. Relevant Tests: they did a COVID test when he was admitted to hospital 30Jan2021, gave results when he left the hospital-took them 6 days-unknown result. They did X-rays and scan of his abdomen to monitor intestinal blockage-results unknown. Blood work done but nothing remarkable there-results unknown. His blood pressure actually was low while in hospital-specific results unknown. Glucose levels were very high while in hospital which he is sure was because they had him on an IV drip that must have had glucose in it because he was not eating anything and when in pain and anxiety his sugar goes up-further details of results unknown. Patient had no further information to provide regarding testing/investigations/lab work, blood work, imaging, x-rays, etc for this report. Outcome of events were reported as unknown.

shivering/having in and out chills; slight fever; fever, headache, dry heaves, fatigue, and crazy dreams; Adding strange dreams/crazy dreams/ so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up; hands were cold; headache fades in and out; Dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM5318, via an unspecified route of administration in the right arm on 08Feb2021 at 11:45 (at the age of 78-years-old) as a SINGLE DOSE for Covid-19 Vaccination. Historical vaccine includes BNT162B2 Dose 1, Lot Number 'He thinks its EL3302'. The patient had no known medical history or allergies. Concomitant medication included metoprolol tartrate (METOPROLOL TARTRATE), lisinopril (LISINOPRIL), atorvastatin (LIPITOR [ATORVASTATIN]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Late on Wednesday 10Feb2021 The patient experienced his hands were cold, he went to bed and he was shivering, he had to put on clothes and 3 quilts and in the meantime he was having in and out chills and slight fever, fatigue and crazy dreams/so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up/three types all repeating four or more times and on Feb2021 experienced headache fades in and out and dry heaves. The patient underwent lab tests and procedures which included pyrexia: little high (using the strips on his forehead) on an unspecified date. As a result of the event abnormal dreams patient did visit a professional office/clinic visit. No treatment was given for the event. The clinical outcome of the event shivering/having in and out chills, slight fever, dry heaves, fatigue, headache and hands were cold were unknown while abnormal dreams was recovered Feb2021.

artery had been nicked and they went in and fixed that; lower right abdominal area was swollen and he was in a lot of pain; lower right abdominal area was swollen and he was in a lot of pain; he had a hernia removed; his hemoglobin has been going up and down; He shrunk, he is 5'11.75; This is a spontaneous report from a contactable consumer (patient's wife) reported that a 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient just recently had surgery he had a hernia removed and a week after that; he had the operation done arthroscopically and a week after that; the lower right abdominal area was swollen and he was in a lot of pain and he ended up going to the hospital and they admitted him in the ER and they gave him some Morphine and hooked up to all kinds of stuff and eventually they found out that an artery had been nicked and they went in and fixed that and his hemoglobin has been going up and down. At any rate he had surgery again and they cleaned out all of that blood and they didn't find any more leaks but the patient's wife was wondering if it would be okay to have the booster for the COVID vaccine on 18Feb2021 (Thursday). The patient's wife confirmed that all of this happened since him having the first dose of the vaccine, but it was not related. The patient's wife also reported that the patient's height shrunk, and he was 5'11.75". The outcome of artery had been nicked was recovered, and unknown for the rest of the events. Information on the lot/batch number has been requested.; Sender's Comments: There is no reasonable possibility that the reported events were related to BNT162b2. These are more likely associated with the surgical condition and post surgical complications.

pneumonia; strange dreams; While there I went into AFIB; I had a dry cough that I attributed to several bouts of dry heaves; I had a dry cough that I attributed to several bouts of dry heaves; This is spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of bnt162b2 (lot number EN5318), via an unspecified route of administration in right arm on 08Feb2021 11:45 at single dose for covid-19 immunization. The patient had no relevant medical history. Concomitant medication included metoprolol, lisinopril, atorvastatin (LIPITOR). The patient experienced pneumonia on 10Feb2021, while there he went into AFIB (atrial fibrillation) on 19Feb2021, he had a dry cough that he attributed to several bouts of dry heaves on 10Feb2021, strange dreams on an unspecified date. The event pneumonia was reported as serious per hospitalization. The patient was hospitalized for pneumonia from 19Feb2021 to 21Feb2021. Previously reported side effects along with strange dreams and he would also like to mention a couple of more issues. Throughout 10Feb2021 and 14Feb2021 adverse reaction period he had a dry cough that he attributed to several bouts of dry heaves, Since the cough continued and he wasn't feeling better he went to emergency care facility on the 19th and he was diagnosed with pneumonia and went to the hospital and was admitted. While there he went into AFIB. Pneumonia was located in left lower lobe (infectious organism). Discharged from hospital on 21Feb2021. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, Hospitalization for 2 days. The patient underwent lab tests and procedures which included covid test nasal swab: negative on 20Feb2021. Therapeutic measures were taken as a result of pneumonia and cough. Treatment included antibiotics. The outcome of events for pneumonia was resolving, for dry cough was not resolved, for other events was unknown. Facility type vaccine: Nursing Home/Senior Living Facility. No other vaccine in four weeks. No covid prior vaccination. Covid test post vaccination: Covid test type post vaccination Nasal Swab, covid test date 20Feb2021, covid test result negative. Not known allergy.

diarrhea which persisted for more than four days with liquid or very loose stools; Five or more bowel movements/day with considerable gas; This is a spontaneous report from a contactable consumer reported that a 78-year-old female patient (consumer) received first dose BNT162B2 (COVID 19, brand: Pfizer, Solution for injection, lot number: EN5318) via an unspecified route of administration on 28Jan2021 at 15:30 on Left arm for covid-19 immunization. Patient medical history included Type II diabetes, heart problems, bypass surgery in Sep2019. Concomitant medications were not reported. It was reported that, three days after receiving the injection, on 31Jan2021 she developed diarrhea which persisted for more than four days with liquid or very loose stools. Five or more bowel movements/day with considerable gas. No fever, aches. No urge for bowel movement when there was nothing to evacuate. Age at vaccination was 78 Years. 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. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. No seriousness criteria was reported. Outcome of events was recovering.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic reporting body aches, heaches, and chills since receiving vaccination five days prior. No shortness of breath, chest pain, vomiting, or diarrhea. Patient was not in distress or ill-appearing: normal breath sounds (no wheezing, rhonchi, or rales). Five days after clinic visit (ten days after vaccination) patient's wife and daughter reported patient had poor appetite and feeling worse since clinic visit: weakness, pain all over, decreased oral intake, and cough with phlegm. Advised to go to the emergency room immediately. Patient's daughter reported the next day patient admitted to another facility and COVID-19 test was positive.

fell, hit head, confusion, memory loss, balance disorder, tremors and shaking, vomiting, headache, high blood pressure, TIA, CVA, aneurysm

Shortness of breath/out of breath; Breathing very heavily as if I had been running; Nausea; My body was clammy all over; Blood pressure was 178/106; Tightness in my chest; Kept taking deep breaths, with an overall feeling of weakness; Feel unwell with cold like symptoms, including chills; Feel unwell with cold like symptoms, including chills; feel unwell with cold like symptoms, including chills; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old male 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 22Jan2021 (Batch/Lot Number: EL3302) at single dose for covid-19 immunisation. Medical history included Heart stent placed in 2016, high blood pressure, enlarged prostate. Concomitant medication included rivaroxaban (XARELTO); metoprolol; losartan; aspirin [acetylsalicylic acid]. The patient previously took finasteride, dutasteride and experienced Known allergies. It was reported that on 24Jan2021 00:15/12:15 AM patient had shortness of breath within 30 minutes of receiving the injection, and was breathing very heavily as if I had been running. By the time I got to the car, I was totally out of breath. Any slight exertion over the next week would bring this on. The day after the injection on the morning of 24Jan2021 I awakened with nausea, my body was clammy all over, Blood pressure was 178/106, tightness in my chest, and kept taking deep breaths, with an overall feeling of weakness. Went to the ER ,and was checked out and released after all tests were neg. for a heart problem. I continued to feel unwell with cold like symptoms, including chills. Adverse event treatment was emergency room protocol for a suspected heart attack, Patient did not had covid prior vaccination, Patient did not tested covid post vaccination. Outcome of the all events was recovering.

Onset second morning after injection: headache, chills, nausea, loss of motor control in legs ( unable to stand or walk, unable to roll over to get out of bed), profuse sweating. About 1pm my wife assisted me to the bathroom toilet, where I passed out for approx 30 mins. These severe reactions finally started to recede about 6pm, although the sweating continued into Sunday. Mild nausea, and mild headache continued into today Tuesday.

Started symptoms of a cough, sore throat, diarrhea, and upset stomach on 03/08/2021. Received monclonoal antibody therapy on 03/19/2021.

myalgias, chills, weakness, nausea. He cannot vomit secondary to history of Nissen fundoplication. In the middle of the night on 3/28 he got up to go to the bathroom and was too weak to get off the toilet - to the point where he had to lower himself to the ground, so EMS was notified and reportedly found him with a fever of 104 Fahrenheit. Hospitalization x2 days. Discharge home.

back started hurting/back aching and hurting; Chills; coughed once and stomach rolled; chest tightness; coughed once and stomach rolled; arm started hurting; my neck got stiff; can't sleep; This is a spontaneous report from a contactable consumer via medical information team. A 78-year-old male patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Right on 12Mar2021 11:00 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included HIV positive ongoing (Diagnosed 8 years ago); Psoriasis ongoing (over 5 years that he was diagnosed); Diabetes from 2017 and ongoing; Family History includes operation on face for melanoma. Concomitant medication included abacavir sulfate, dolutegravir sodium, lamivudine (TRIUMEQ) at 600 mg, 1x/day; then 50 mg, 1x/day; then 300 mg, 1x/day ongoing all were via orally for hiv infection; metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET XR) orally 50 mg, 1x/day for diabetes ongoing; adalimumab (HUMIRA) from an unspecified start date and ongoing at 40 mg every 14 days for psoriasis. It was reported on friday the 12Mar2021 week patient took the shot at a hospital. On the 13Mar2021 his arm started hurting and his neck got stiff. The 14Mar2021 his back started hurting like a knife, chest and back was tight. He states his back hurts and has chest tightness; coughed once and his stomach rolled up on 14Mar2021. On the 15Mar2021 same result, back aching and hurting. The 16Mar2021 he went to the hospital and took the x ray of his back and front and couldn't find nothing. States his lungs were ok and everything was ok so he doesn't know what is going on. Clarified that he went to the Emergency Room at the hospital, he was not hospitalized. He was treated in the ER and released the same day. on the 17Mar2021 his back was killing him. he can't sleep in Mar2021. He states that he still hurts this morning and has chills on 17Mar2021. The outcome of the events Cough; Stomach discomfort; Neck stiff; vaccination site pain was recovered on 14Mar2021; Chest tightness; Chills, Back pain was not recovered; Sleep disorder was unknown.

Large influx of saliva in mouth; Nauseated; Thrown Up; stomach cramping; This is a spontaneous report from a contactable 78-Years old male consumer reported for himself that he received bnt162b2 second dose of (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL0739), via an unspecified route of administration on 09Feb2021 at single dose in left arm for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on 18Jan2021 (First dose lot number: EL8982, received both COVID-19 Vaccines in his left arm). On 12Feb2021, the patient experienced stomach cramping and on 15Feb2021, Large influx of saliva in mouth and he felt nauseated and thrown up. The outcome of the events was unknown. Information on the lot batch number has been requested.

Collapse of lung; Diarrhea; very weak; lost his appetite; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered on right arm on 03Mar2021 (Batch/Lot Number: EL9261) at single dose (at the age of 78 years old) for COVID-19 immunisation. The patient medical history included had vascular problems in his legs, and his legs were very clogged. The doctors couldn't do anything and tried to do a catheterization. Thyroid was not okay, and now his doctor increased his thyroid medication. The reporter blamed the hospital for doing something wrong when her husband was there the last time. She said the hospital made a mistake and gave her husband the wrong medication. She said the first time her husband was at the hospital, the hospital didn't give her husband his thyroid medicine. She said the second time, the hospital gave her husband the wrong dose of medication. Concomitant medications were not reported. The patient previously took BNT162B2 (lot number: EN9581) dose 1 on 10Feb2021 for COVID-19 immunisation. The patient previously took flu vaccines in Sep2020. On Mar2021, the reporter's husband was okay at first. She said now her husband had diarrhea and pooped in his clothes. She said her husband was very weak and lost his appetite. She clarified her husband's symptoms started probably 2 weeks ago, and her husband was worse, and like a different person now. She said her husband used to eat at the table, and now he just sits in his chair, and after 5:00PM he wants to go to bed. She said she was not sure if her husband's symptoms were related to the COVID-19 Vaccine. She said her husband was supposed to have heart bypass surgery on Monday (22Mar2021), and his surgeon called on Saturday night (20Mar2021) and called off her husband's surgery. She said the surgeon said her husband had a collapsed lung. She said her husband had a chest x-ray in late Feb2021 and his lungs were clear. She said everything that happened to her husband, happened after he had his second dose of the COVID-19 Vaccine. She said she was not sure if her husband's collapsed lung (19Mar2021) was related to his second COVID-19 Vaccine. She said before getting the COVID-19 Vaccine, her husband did not have a problem with his lungs. She said her husband's surgeon can't figure out why her husband's lung collapsed. She said she can't prove his collapsed lung was a side effect of the COVID-19 Vaccine, but her husband never had sick lungs in his life. She said she knows her husband doesn't have the COVID-19 Virus because he had to be tested on Saturday (20Mar2021) for the COVID-19 Virus before he could have his surgery on Monday (22Mar2021). She said her husband's COVID-19 Virus test was negative Saturday, but he has all these problems. The patient's wife was afraid to give her husband Pepto Bismol, so she didn't give her husband anything. She said her husband has an appointment on Thursday (25Mar2021) with his primary care doctor to talk about his symptoms. The outcome of collapsed lung was unknown and other events were not recovered.

Presented to hospital with shortness of breath for one week on 4/13/2021. Additional symptoms reported include productive cough with blood tinged sputum, diarrhea, and food tasting like salt. Supplemental oxygen, tocilizumab and remdesivir treatment initiated

dehydration; Fatigue; chills; headache; fever; nausea; body ache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN5318) via unspecified route of administration in left arm on 26Jan2021 at 11:00 AM (at the age of 78-year-old) for COVID-19 immunization and other unspecified pfizer vaccine (Lot number EN538) in left arm on same date 26Jan2021. Medical history included blood pressure and covid. Patient had no known allergies. Concomitant medications included unspecified blood pressure medications (in two weeks). No other vaccine in four weeks. Patient experienced fatigue, chills, headache, fever, nausea, body ache on 26Jan2021 at 04:00 AM and dehydration on an unknown date. Adverse event resulted in emergency room/department or urgent care. Treatment was received for all events. IV treatment was received for dehydration event. Patient had covid prior vaccination, Patient did not test for covid post vaccination. The outcome of all the events was unknown. No follow-up attempts are possible. No further information is expected.

Patient admitted to Hospital on 4/16/2021 with 2 weeks of generalized weakness, chills, poor oral intake and nonproductive cough. Chest x-ray shows consolidation. Patient tested for covid-19 which returned positive on 4/18/21. Patient remained hospitalized and started on steroids and vitamin c/e after covid testing returned positive. Patient respiratory status worsened requiring high flow nasal cannula and BiPAP as needed. Patient did not want to be intubated and decided to go to comfort care. Patient passed away on 5/3/21 in the hospital.

dehydration; Chills; low fever; nausea; body ache; fatigue; headache; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, second dose) solution for injection intramuscular in the right arm on 19Feb2021 at 10:30 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and overweight. Concomitant medications were not reported. Historical vaccine included BNT162B2 (first dose, lot EN5318) for COVID-19 immunisation on 26Jan2021 and experienced dehydration, fatigue, chills, headache, fever, nausea, body ache, and cough. On 19Feb2021 at 18:00, the patient experienced dehydration, chills, low fever, nausea, body ache, fatigue, and headache which resulted in an Emergency Room visit. The patient was treated for dehydration. The outcome of the events dehydration, chills, low fever, nausea, body ache, fatigue, and headache was recovered in Feb2021. Information on Lot/Batch number was available. Additional information has been requested.

Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination.

After receiving the injection, patient had not been feeling well. Low appetite, lightheaded, fatigued, difficulty breathing. They had been traveling and returned on 3/7. He was tested for covid and the test was positive. He presented to the ED on 3/25/21 and was subsequently admitted to the hospital for 4 days with pneumonia.

3/3/2021 Chief Complaint Patient presents with ? Covid-19 Screening diarrhea, weakness, fatigue. wife is positive. Clinical Support 3/5/2021 COVID-19 virus infection Dx Medication Infusion Reason for Visit Encounter Date: 3/5/2021 ? ? Signed Arrived to the ambulatory infusion site alone via car. Reports intermittent diarrhea, dry nonproductive cough, fatigue.

ED 3/7/2021 MC MC Source Organization Encounter Summary 78 y.o. Male; born Jan. 03, 1943January 03, 1943Encounter Summary, generated on Apr. 02, 2021April 02, 2021 Reason for Visit Reason Comments Shortness of Breath Fever Encounter Details Suspected COVID-19 virus infection (Primary Dx) ED Provider Note Patient Chief Complaint Shortness of Breath and Fever History of Present Illness 78-year-old male, PMH is documented below, presenting to the emergency department with fever, cough and shortness of breath. Patient reports that he has been ill since Tuesday. He developed a productive cough bringing up some clear sputum. States he has some shortness of breath with exertion. He denies any chest pain. He denies any palpitations, lightheadedness or syncope. No headache or neck stiffness. States that he has been afebrile until today. Patient had a temperature of a 101° for EMS he has also been having some diarrhea. States he has no loss of taste and has chronic loss of smell. He has not come into contact anybody with COVID-19. Denies any history of DVT or PE. No lower extremity pain or swelling. Patient had his 1st Covid vaccination, but has not received his 2nd. Office Visit 5/7/2021 Family Medicine Cough +1 more Dx Cough Reason for Visit

lost 10 lbs; I vomited for three nights; lost my appetite; had diarrhea the first week; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in right arm, on 02Jan2021 at 08:30 AM (at the age of 78-years-old) at 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. No COVID prior vaccination and no COVID tested post vaccination. The patient had no known allergies. No other vaccines received in four weeks and no other medications taken in two weeks. The patient lost 10 lbs in 4 days, he vomited for three nights, lost the appetite and had diarrhea the first week, all occurred on 03Jan2021 at 12 AM. No treatment was received for the events. The patient had recovered with sequel from lost 10 lbs on 07Jan2021, from vomited for three nights on 06Jan2021, from lost the appetite and had diarrhea the first week on 10Jan2021. Information on the lot/batch number has been requested.

Light headedness/ Dizzy; Equilibrium was way off/ he was wobbly; Nauseous; Mild case of vertigo; he ached; felt terrible/ yucky feeling; Stayed down all the day/ he was wobbly; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Jan2021 17:20 (Batch/Lot Number: EL3249) as single dose for COVID-19 immunisation. Medical history included tinnitus, Blood pressure, Gout, Cholesterol, Acid Reflux. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for blood pressure abnormal from an unspecified start date and ongoing; aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal from an unspecified start date and ongoing; allopurinol (ALLOPURINOL) taken for gout from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. No prior vaccinations within 4 weeks. No history of previous immunizations with the Pfizer vaccine considered as suspect, this was the first dose. No additional vaccine administered on same date of the Pfizer suspect. On 13Jan2021, the patient received the vaccine. He clarified the reaction as, on Saturday 23Jan2021 all of a sudden it was quick he got real light headed, dizzy, he felt like his equilibrium was way off. He felt like he had a mild case of vertigo. He was wobbly, he ached, and felt terrible. It was a yucky feeling. He also felt nauseous, and it went away soon as he ate. He had never had a feeling like that before. He stayed down all day. He noticed all these events that occurred on Saturday 23Jan2021 started late morning around 10-11 in the morning. By the afternoon he was on his back for the rest of the day. It knocked him for a loop. Sunday 24Jan2021 he woke up and felt a little better. He still had some of the symptoms, but they were milder and kept getting milder through out the day. By Sunday afternoon they were almost gone and by Monday 25Jan2021 he felt normal and great. Tuesday 26Jan2021 these same feelings hit him again, but not the same way and was not as bad. Then 27Jan2021, they were gone and he felt fine. He went to the doctor's office yesterday (27Jan2021). The doctor thought he was having an inner ear problem. He has a history of tinnitus and the doctor thought this was causing the light vertigo symptoms. He was light headed, wobbly. He was prescribed Meclizine-25mg one tablet by mouth three time a day. Now, today, 28Jan2021, he woke up this morning and he had the same feelings again. He was wobbly. He had the same feelings that he experienced on Saturday 23Jan2021. However, they were milder. He felt like it is a little vertigo. He did not feel stable. He had never had anything like this happen before. The patient stated he is pretty healthy for his age. he is very active. He usually plays golf, but has not recently. The patient believes he is having a reaction from vaccine, he is not sure, but he is having some of the symptoms. The doctor provided him with medication, but he has not started it yet. He does not know if he should. Caller is thinking these events are related to the shot. He is due to get his second shot on 03Feb2021. Outcome of the events was not recovered.

chills, vomiting,fever,dark urine. Went to clinic and was given rx for nausua after 1st vaccine. After 2nd vaccine went to Doctor and had a series of blood tests and ct scan. Symptoms subsided after a few days, dark urine for a couple of weeks. Tests showed: ast(sgot) 90 , alt (sgpt) 210

loss of appetite; fatigue/completely drained/ragged tired; he got sick the next day/has been sick; whenever he tried to do something, he will break out in a cold sweat; This is a spontaneous report from a contactable consumer other non-health professional (patient) via medical information team. A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, lot number: Unknown, Expiration date: Unknown), via unspecified route of administration on left arm on 28Jan2021 (age at vaccination 78-year-old) at 1st dose, single for covid immunization. The patient had no medical history. There were no other products. On 28Jan2021 patient took 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and on 29Jan2021 (day after) the patient experienced loss of appetite, fatigue, and completely drained. Reportedly on 29Jan2021 patient had been sick. The patient experienced ragged tired, totally drained, and whenever he tried to do something, he will break out in a cold sweat. Patient stated that he got a COVID shot on 28Jan2021 (last Thursday), and he had been sick ever since. Patient stated that the sickness does not seem to be going away, it was about the same, it did not seem to be getting any better. Patient was wondering how long this is supposed to last, and if there was something he could do. Patient wanted to know how long he will be experiencing these symptoms. The case was assessed as non-serious as per reporter. No investigation assessment was done. Reporter confirmed that he had no other vaccines on the same day as his COVID vaccine. Reporter did not have his COVID Vaccination card with him at the time to provide Lot number. The outcome of the event was not recovered for sick and unknown for all other events. 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.

Dizziness; loss of balance resulting in falling; Chills; fatigue; sleepiness; diarrhea; Loss of strength; loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received a first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number = unknown) via an unspecified route of administration in the left arm on 05Feb2021 at 01:00pm (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma, shingles (15 years ago) and anemia. The patient was allergic to codeine. Concomitant medications included vitamin b12, c, d3, iron and Tylenol (MANUFACTURER UNKNOWN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccination. On 05Mar2021 at 1:00 PM, the patient experienced dizziness, loss of balance resulting in falling, chills, fatigue, sleepiness, diarrhoea, loss of strength and loss of appetite. On 06Mar2021, the patient underwent COVID-19 virus test (nasal swab type) and the result reported as negative. Adverse events resulted in emergency room/department or urgent care. Clinical outcome of the events dizziness, loss of balance resulting in falling, chills, fatigue, sleepiness, diarrhoea, loss of strength and loss of appetite was reported as not recovered. Information about lot number cannot be obtained and no further information is expected.

GI distress started 18 hrs after dose.; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EN6203 Expiration Date: not reported), via an unspecified route of administration, administered in left arm on 06Mar2021 at 11:00 (at the age of 78 years old) as second dose, single for COVID-19 immunisation in a Clinic. Medical history included chronic obstructive pulmonary disease (COPD) and arthritis, both from an unknown date. The patient did not receive any other vaccines in 4 weeks and prior to vaccine the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: E69266), via an unspecified route of administration administered in left arm on 13Feb2021, (at the age of 78 years old) as first dose, single for COVID-19 immunisation. The patient experienced GI (gastrointestinal) distress started 18 hours after dose on 07Mar2021 at 05:00. No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of the event was recovered on unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

1st vaccine: Pain in shoulder neck and head same day. Next day whole body was hurting. After 3 days gout flare-up. NP did labs. Found GFR to be 18.Had been in the 40's prior to vac. 2nd vaccine: worse. Body pain, extreme nausea and vomiting. Dizziness, difficulty walking. Down for 14 days. June 17: Chest pain of # 9and jaw pain. No history of heart problems. To ER with wife. Admitted to hospital. Discharged home 6/19/21. Now sleeping a lot. Trying to resume activity.

Came in to the hospital for a GI Bleed and had a polypectomy peformed, and upon admittance tested positive for COVID-19. The patient was released from the hospital after about 3 days and is currently at home recovering Doctor seeing him at the hospital.

Pfizer COVID vaccine EUA Pfizer Dose 1 2/13/21 (EN6201) Pfizer Dose 2 3/13/21 (EN6204) COVID Positive 5/24/21 5/24/21: 78-year-old man brought to the emergency department for further evaluation of worsening shortness of breath and cough. He was in his usual state of health until approximately 11 days ago when he started to have upper respiratory symptoms characterized by congestion, rhinorrhea, sneezing episodes. Symptoms gradually worsened until 5 days ago when he started to have for productive cough accompanied by shortness of breath. He denies accompanying fever, chills, nausea or vomiting. His sister who accompanied him has been checking on him daily and has noted worsening bouts of coughing as well as shortness of breath, unable to keep up with ADLs. Upon checking on him today she noted that his lips were blue, brought in to the emergency department by private passenger car and in trial urge his oxygen saturation was noted to be 64% on room air. He was immediately started on supplemental oxygen via OxyMask, nebulizer therapy. COVID-19 rapid antigen test was subsequently positive, CT pulmonary angiogram was done which is negative for PE but also did not demonstrate any evidence of pneumonia. He is fully vaccinated against COVID-19 since March, denies any known contacts being treated for or with symptoms suggestive of COVID-19 infection. While in the ED continued to deteriorate requiring increasing amounts of oxygen via OxyMask, desaturating to 82-85% on 15 L OxyMask. Has been started on NIPV and will be admitted to the ICU for further treatment and evaluation. Of note, he reports that he and 5+ of his family members were all fully vaccinated and all tested positive to COVID around the same time. 6/14/21: The patient presented to the hospital on May 24 with cough and shortness of breath, COVID-19 test positive, initially he was hypoxic requiring 6 L of oxygen then his oxygen demand increased until he require to be on BiPAP and high-flow nasal cannula, then on May 29th require endotracheal intubation the ICU and started on Remdesivir, Decadron, but he was not candidate for Acterna, on June 3rd the patient had a fall with dislodged endotracheal tube require immediate re-intubation and his CT show simple nondisplaced skull fracture and subgaleal small hematoma without intracranial hemorrhage. Patient extubated on June 6 to BiPAP then the oxygen requirement taper down. The patient post extubation kept having shortness of breath and cough, sputum culture grow Klebsiella pneumonia and he was on Zosyn which cover it and will complete the antibiotic on June 15th. The patient is hypercoagulable with elevated D-dimer 2 to COVID-19 infection and will continue Lovenox b.i.d. with his aspirin and Plavix for CAD with pantoprazole. Will continue his chronic steroid. The pulmonologist recommend to keep the patient in isolation due to prolonged virus shedding. On per oral Vanco for C diff prophylaxis due to history of recurrent C diff infection and he is currently on antibiotic. Echocardiogram showed normal EF without significant valvular disease. Patient had episodes of dysphagia and swallow studies show some aspiration and he placed on pureed diet/dysphagia level 1. Sign-out given to SELECT LTAC team, they will follow on management.

Patient is a 78-year-old white male who was vaccinated with Pfizer Covid 19 vaccines on 3/5 and 3/26/21 with a known history of chronic respiratory failure and COPD secondary to a work related injury that occurred in the 1980s followed by a compensation/pulmonary physician as well as obesity and diastolic chf, hx atrial fib, who presented to the emergency room on 6/26/21 with a chief complaint of shortness of breath with copious amounts of thick yellowish secretions. Patient was recently admitted and discharged at hospital on 6/11 for pneumonia and a pleural effusion. It was determined during that admission that he had malignant cells in the fluid consistent with adenocarcinoma and chose to not work this up any further and foregone any treatment. He returned back to the hospital with continued shortness of breath, weakness and poor p.o. intake despite using the nebulizer at home. There was no fever no hemoptysis chest pain or pleuritic pain. Imaging again reveals significant airspace disease involving the right lower lobe diffusely and partially involving the right middle lobe on CAT scan with a small right pleural effusion seen. He had a CT of the abdomen and pelvis which was negative for any malignant spread. Patient was also seen by oncology who discussed further work-up, prognosis with the patient and felt that overall he was too ill to pursue any further work-up or treatment at this time and recommended hospice/palliative care. He was discharged home on hospice care with a terminal prognosis on 7/1/21

Received covid shots. Within in a few hours developed severe all body muscle cramping, pain and nausea. Extreme symptoms of gout w/pain and cramping in feet / ankles. Did not eat for 4 days - fatigue, low energy. these symptoms lasted for 4 days. After the second shot on 6-3-21 - Became weak and ill the next day and was taken home from work with extreme pain in right foot and knees. Extensive all over body painful muscle cramping, weakness. Fatigue. To this day has not been able to carry on his normal walking routine. Had consulted with physician.

Still experiencing extreme nausea; Exhaustion weeks after; Headache; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 10Mar2021 at 15:00(at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included kidney pain and cancer. The patient did not have any allergies to medications, food, or other products. Concomitant medications included atorvastatin calcium (LIPITOR) and magnesium (MANUFACTURER UNKNOWN) started on unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the arm left on 16Feb2021 at 18:00 (at the age of 78-years-old) 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 four weeks prior to the vaccination. On 14Mar2021 the patient experienced extreme nausea, exhaustion weeks after and headache. The patient was not a person who got nausea at all and was active normally. The patient did not receive any treatment for the event. 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 extreme nausea, exhaustion weeks after, headache was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

first signs of were in last week of February and first week of march. approximately 5 times between Feb 21 and April 15 I had what I thought to be indigestion, constant belching with a little pain in center of stomach area, these symptoms disapeared after a few hours and tums. All started in early morning around 630 am. On April 15 it happened again but continued all day, went to urgent care at around 330n they did egg which was fine but advised going to emergency room for better tests,

Low energy/weakness; loss appetite; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 15:30 (Batch/Lot Number: EN6202) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. There were other concomitant medications in two weeks. The patient experienced low energy/weakness, loss appetite on 05Mar2021. The events resulted in emergency room visit, and were serious per hospitalization and disability. The patient was hospitalized for low energy/weakness and loss appetite for 12 days. The patient underwent lab tests and procedures which included Nasal Swab (covid test): unknown results on an unspecified date. Therapeutic measures were taken as a result of the events with Plasma exchange. The outcome of the events was resolving. Follow-up attempts are completed. No further information is expected.

chest was congested; kind of hard to breath; spitting out crud; This is a spontaneous report from a contactable consumer. A 78-year-old male patient (non-pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiry Date: unknown), via an unspecified route of administration on arm left on 19Feb2021 11:00 AM (age at vaccination: 78 years) as dose 1, single for COVID-19 immunization at Heart hospital. The patient medical history included COPD diagnosed a few years ago, high blood pressure, allergic to penicillin and iodine. History of all previous immunization with the Pfizer vaccine considered as suspect and Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. The patient Concomitant medications included Lasix for Blood pressure (His dose is either 10mg or 20mg, but he is not sure. He takes one tablet per day. He has been on it for a while). It was reported that, the patient got COVID shot on Friday and was good all day on Friday. He woke up on Saturday and was all congested. He started spitting out crud on Saturday. It was kind of hard to breath. Caller clarified that it was hard to breathe because his chest was congested. It was reported that he goes to a clinic and change the doctors frequently and he also goes to heart hospital. He has not been to the ER or to his physician's office. He goes back in two weeks for the second shot. The breath sounded like a popcorn. The patient woke up with congestion between 8:30AM and 9:00AM. The patient Wanting to know if difficulty breathing due to chest congestion is 'supposed to happen'. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

loss of consciousness; respiratory distress Narrative: Patient tolerated his 1st dose of the COVID-19 vaccine well, on 12/16/2020, and received his 2nd dose on 1/6/2021. Patient had some mild clinical decline the past few days prior to 2nd vaccination, with a decreased appetite and some increased fatigue per nursing report, but no significant changes. He experienced nausea on the evening of 1/6/21, which was effectively managed, but by early morning he spiked a fever of 102.9 with a sat of 86.1%. He continued to deteriorate from that point on and died 1/7/21 @13:20. Clinically, the presentation was most consistent with an aspiration pneumonia.

Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home.

Threw up 4 times; Had diarrhea 3 times; Tired; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date unknown) at 79-year-old via an unspecified route of administration in the left arm on 14Jan2021, 9:03 AM at a single dose for COVID-19 immunization/ because people are dying. The patient's medical history was not reported. Patient however stated he is familiar with cancer, epileptic seizures, and heart attacks (pending confirmation if referring to medical history). The patient lives alone and has nobody. Concomitant medications were not reported. On 15Jan2021, from 2:00AM, the patient threw up 4 times, had diarrhea 3 times, and was tired. The patient recovered from the events "threw up" and "diarrhea" on 15Jan2021 (time unspecified). Outcome of the event "tired" was not recovered. It was reported that the patient was scheduled for his second dose on 04Feb2021 at 3:30 PM. Information on the lot/batch number has been requested.

Dizziness, nausea, irregular HR. EKC revealed AF. Drank full glass of red wine at 2 AM on the day of the vaccine. Went to the ED

After duing light work on Saturday morning. I sat down for a few minutes and felt a little light headed. My stomach became quisy and I had to go into the bathroom, became nauseated and had to vomit. I had a quisy stomach most of the balance of the day. I experiecnced a restless night. However, by mid-morning Sunday I began to feel better and have had no additonal inegative effect. The only other unexplained item was that on Sunday I checked my blood presure and it was 154/ 85. This is very unusual, as due to the nifedipine I take for my DES, my average for years is around 125/80. Today, Tuesday, I checked it again and it still at 158/87. I have an appointment with my cardiologist in 2 weeks and will discuss this with him.

having stomach issues , trouble eating , is feeling a bit better today , feeling stronger , still has not taken medications .

meningioencephalitis; Severe headache; severe nausea; migraine; small subarachnoid hemorrhage postulated; This is a spontaneous report from a contactable Physician (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Left arm on 07Jan2021 at 02:30 PM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included hypertension, hypercholesterolemia, hypothyroidism and dust allergy. Concomitant medications in two weeks prior to the vaccination included levothyroxine sodium (SYNTHROID), chlorthalidone and rosuvastatin calcium (CRESTOR). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 20Jan2021 at 04:00 PM patient experienced severe headache with severe nausea requiring emergency room (E R) visit and intravenous (I. V) morphine, toradol and ondansetron. Computed tomography angiography (C T A) of head performed on unknown date was normal. Pain unbearable. Lumbar puncture (L P) not done. Pain persisted four days later, though diminished. Diagnosis (Dx) uncertain but possible migraine with right (r) eye preference or small subarachnoid hemorrhage postulated. Another troublesome possibility could be vaccine reaction (meningioencephalitis). Events resulted in Emergency room/department or urgent care. Treatments received included IV morphine, zophran (as reported), ketorolac tromethamine (TORADOL) and metoclopramide hydrochloride (REGLAN). Patient had no COVID prior vaccination. Patient was not tested for Covid post vaccination. Patient recovered with sequel from the reported events.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for events meningoencephalitis, headache, nausea, migraine and subarachnoid hemorrhage. 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.

STOMACH CRAMPS LOWER BACK AROUND KIDNEY AREA ( NO KIDNEY MALFUNCTION) DIFFICULT TAKING A FULL BREATH FEELS LIKE A BALL BAT TO MY CHEST PAIN STARTED ON 02-05-2021. TODAYS DATE IS 02-08-2021. BLOOD PRESSURE IS 124/68 HEART RATE IS 51. OXEG IS 99.1 RIDE MY ROAD BIKE 30 MILES EVERY OTHER DAY.

PT states active lymphoma, sees Doctor. Did not discuss vaccine with PCP. Received verbal permission from Pt to contact D=providers. TC to Doctor's office, spoke with nurse, who states, spoke with Doctor who gave permission to vaccinate. 14:22 - After vaccination patient stood and stated he felt dizzy. Mentioned has a history of anxiety with vaccination. Rested while seated. After 5 minutes, c/o nausea, denies SOB, urticaria, or other SX anaphylaxis. Escorted via WC to first aid area. 14:33 VS: BP- 162/78 P 56 O2 Sat 98%. Provided rest / H2O. 14:45 - States SX resolved. VS - BP 164/72P - 52, O2 Sat 97%. Escorted to driver @ 15:00.

PATIENT REPORTED BODY ACHES, HEADACHE, NAUSEA AND THREE EPISODES OF VOMITING. HE WAS TREATED WITH IV FLUIDS, ZOFRAN, AND TYLENOL AND REPORTED SIGNIFICANT IMPROVEMENT IN SYMPTOMS.

2 days after vaccine - left sided weakness in arm and leg, speech/swallowing impairment. ER then 3 days in hospital- home with walker, assistance and home health.

aches and pains; nausea; some confusion; the patient woke up in the middle of the night on 20Jan; This is a spontaneous report from a contactable consumer A 79-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 19Jan2021 in the left arm at 18:00 at SINGLE DOSE for covid-19 immunisation . Age at vaccination: 79 Years. Facility where the most recent COVID-19 vaccine was administered:Public Health Clinic.The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included history high blood pressure, covid-19 (covid prior vaccination: Yes) and the patient has a pace maker. Concomitant medication included hydrochlorothiazide, losartan potassium (HYZAAR), carvedilol (COREG), acetylsalicylic acid (ASPIRIN , colecalciferol (D3 VITAMIN). The patient experienced Sleeplessness on 20Jan2021, Ache , nausea and confusion on 21Jan2021 02:00.Clincal course reported as follows: the patient woke up in the middle of the night on 20Jan with aches and pains, nausea and some confusion, confusion resolved in 15 min, tylenol administered for aches and pains, no issues when patient woke up in the morning.All events reported as non serious . The patient was recovered from confusion on 21Jan2021, while the outcome of the other events was recovered on unknown date .Since the vaccination, the patient had not been tested for COVID-19 information on the lot/batch number has been requested

on 1/23, rt became winded and confused, weak and began to require more assistance with ADL's, 1/24/21 acting bizzare, anxious, uncomfortable, increasingly more confused, restless, 1/27 blood noted in urine, SOB and abdominal breathing, was sent to ER - returned with dx of SOB and UTI. 1/29/21 confused and trouble voiding, very restless, 1/30/21 confused and restless, 1/31/21, confused and anxious, 02/02/21, very low heart rate, lethargic, admitted to hospital with cystitis and bradycardia, 2/4/21 returned to facility, 2/11/21 received second dose of Pfazer_ BioNTech vaccine, 2/17/21 very lethargic, bradycardia, 2/21/21 large amount of rectal bleeding, sent to hospital and admitted - remains in the hospital at this time

Initially mild pain and tenderness Left arm shoulder muscle. On third day after second vaccination, should symptoms gone but I started to develop diffuse myalgias. By 4th day, began having problems with my memory. I could not figure out some instructions on a computer program. I had some trouble recognizing a common object in my hand. Then mild ataxia. Excessive sleepiness in 2-3 hour intervals. On 8th day, developed abdominal pain similar to diverticulitis. And became very constipated. I had forgotten to take the Parnate and missed two doses. I had forgotten to take Metamucil and Miralax. these led to the constipation and abdominal pain. On advice of psychopharmacologist, I resumed Parnate and started to feel better. I resumed laxatives and good effect. Abdominal symptoms abated in two additional days. I had gone to ER but seen only informally by my medical friends. After 3 hour, and getting better, I left. Blood tests were normal. No exam. Since 02/27/2021, I have felt perfectly normal. Recovered.

Patient was admitted for possible GI bleed. He was seen by GI who suspected that bleeding was due to hemorrhoids. Patient was discharged and advised to follow up with PCP and GI. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

After receiving vaccine I felt slow and nauseated, then started having pain in rib cage that lasted a while, i ended up forcing myself to throw up and felt a little better, the pain moved up and i was running a fever. The next day I felt better.

Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 16Feb2021 (lot number reported as EN9581 and EL1282; pending clarification) at the age of 79 years old, as single dose for COVID-19 immunisation. There were no relevant medical history and concomitant medications. On 23Feb2021, seven days after the vaccine shot, the patient experienced diarrhea and it was just resistant (diarrhea won't stop). The patient had been in the hospital (was admitted) from Friday morning (26Feb2021) to 01Mar2021 due to the event; and yesterday morning (02Mar2021) the patient underwent endoscopy and colonoscopy with unknown results. The adverse event required a visit to the emergency room. The patient did not receive any vaccinations 4 weeks prior to the administration of first COVID vaccine. There were no additional vaccines administered on same date as Pfizer COVID vaccine. The patient has not recovered from diarrhea as of this report. Information on the lot/batch number has been requested.

COUGH, WEAKNESS, INSOMNIA, ACUTE ON CHRONIC CKD, ACUTE ON CHRONIC CHF, EMESIS, DEATH Narrative: 1/12/21-PT REPORTED FEELING TIRED, UNABLE TO SLEEP AND EXPERIENCING DYSPNEA ON EXERTION THAT HE FEELS MAY BE RELATED TO RECENT COVID VACCINE 1/17/21-patient admitted to hospital due to 'severe abdominal pain;' received 1 unit PRBC due to symptomatic anemia and weakness (Hgb 8.4->7.1); dx: acute on chronic CHF exacerbation and difficulty breathing, acute kidney injury-CKD Stage IV; HPI includes chief complaint "weakness/sob since last night, cough x 2 weeks since covid vaccine;" HPI includes "pt states that for 2 weeks he has had SOB, cough, chills, body aches, and weakness, symptoms not improved over the last few days, more weak as of late" 1/28/21-transferred to facility 2/12/21-transferred back to hospital due to SOB, abnormal labs, pleural effusion 2/16/21-episode of coffee ground emesis 2/19/21-EGD showed ulcerative esophagitis and gastritis 2/24/21-transferred to SNF 3/9/21-admitted to hospital d/t multiple episodes of vomiting 3/10/21-pt passed away at hospital Possibility that acute inflammatory process triggered by vaccine resulted in patient's eventual death, but difficult to ascertain due to patient's various comorbidities. Patient never tested positive for COVID. Did not experience immediate ADR following 1st dose of vaccine. Did not received 2nd dose due to illness. Hospitalized multiple times following 1st vaccine dose.

runny nose a day or so later; little diarrhea; had a cough; post nasal drip; This is a spontaneous report from a contactable consumer (patient). This 79-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included allergies and diarrhea. Concomitant medications were not reported. On an unspecified date a day or so later after receiving BNT162B2 the patient experienced a runny nose and a little diarrhea. The patient was not sure if it was from the vaccine or not. The patient also had a cough and said it could be from post nasal drip. The outcomes of runny nose, diarrhea, cough, and post nasal drip were unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Developed fever, nausea and vomiting about 24 hours later. Symptoms lasted two days and began to subside, at which time shortness of breath began. Patient drove himself to the hospital for evaluation and treatment on Saturday, March 27th where he collapsed in cardiac arrest. he was resuscitated and stabilized on life support. He died of multiple organ failure on Monday March 29th. The official diagnosis was Severe Septic Shock. It is unclear if any infective agent was identified. It should be noted that sepsis is a condition in which immune dysregulation is inherent and includes cytokine storm activity. The possible correlation between vaccination and the subsequent development of sepsis should be investigated.

Fever and diarrhea following a couple days after the vaccine Being administered. The day prior to hospital emergency admission uncontrollable throwing up extreme side/Stomach/chest pain. Was taken by ambulance to emergency.

wheezing in the morning; shortness of breathe in-between all the other symptoms; bronchitis; hot flashes/warm flush; lack of appetite; trouble walking; uneasiness in the stomach; feeling of warmth; achiness; feeling so bad; nausea; Fatigue; he got extremely cold; not feeling well/feel lousy/sick; My fever is 97.7 degrees fahrenheit but about 2, 3 or 4 o'clock my fever ticks up a little; chills/Shivering; shaking uncontrollably; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, dose 2, administered in Arm Right on 11Mar2021 (Batch/Lot Number: EN6204) as SINGLE DOSE for COVID-19 immunization. Medical history included prostate cancer from an unknown date and unknown if ongoing and major radial prostatectomy from 04Feb2021 to an unknown date. The patient previously received first dose of BNT162B2 (lot number: EN9581) on 17Feb2021 for COVID-19 immunisation and experienced chills, low grade fever and fatigue. There were no concomitant medications. The patient got the second dose of BNT162B2. The patient was fine, had no problems until 15Mar20201 (4 days afterwards), the patient stated, "I started getting chills, shaking uncontrollably , nausea, fatigue, a little bit of everything. I wouldn't be calling you but this has not subsided. It's been 3 weeks now and I'm not feeling well. It ebbs and tides. I've been taking a diary. I went to the ER last Monday because I was wheezing in the morning and had shortness of breathe in between all the other symptoms. They did all kind of blood tests, covid test which was negative, chest x-ray showed bronchitis. Blood work and ultrasound of my bladder with unknown results. They sent me home with a inhaler, steroid and an antibiotic and every day since then it seems like at night 9, or 10 o'clock I start feeling better and sleep through the night. My fever is 97.7 degrees fahrenheit but about 2, 3 or 4 o'clock my fever ticks up a little and I start to feel lousy, my stomach feels. I feel like I have hot flashes; a feeling of warmth with achiness and lack of appetite. So I take my Tylenol 7 or 8 o'clock at night my temperature is 97.7F. I haven't had 1 good day since. I've been to my doctor, ER, I've talked with the CDC. What information do you have for people who have had long term symptoms/side effects? What am I supposed to do? Someone from Pfizer needs to give me advice. If not I'll go to the news network. I don't feel well. It's directly related. No one has given me relief or help. It's impacting my life. I've been sick every day. Is there someone above you who can tell me what to do? I took their (Pfizer's) vaccine that was recommended. It was your vaccine. Not mine. Someone has to have an answer for me. Unless you want to go and have lawsuit and the news. Just think about it, if you had to go through the symptoms of having the flu everyday. Please relay this to someone. If I don't heard back within a week, then I'm going ballistic. It's not going to be pretty. Someone has to get back to me to help. I want someone to tell me that I'm not crazy, I'm not the only experiencing this. There has to be an answer. I took your vaccine. You are responsible. I want to know. I can't be the only one in the whole world who is feeling like this. I've been to the ER and the doctors. I've had every side effects but theirs go away in a few days, but mine hasn't. I need advice, that I'm not nuts, something that will help me get better. I want to feel better. It's effecting my family my life. Doesn't it seem odd? I can't be the only one? Someone has to know something. They (drug companies) like to hide the facts. I am sick because I took BNT162B2 vaccine. I need someone to get back to me." After the second dose of BNT162B2, the patient has been experiencing an achy feeling, heat throughout the body, shivering, shaking, trouble walking, and some fever. He reports taking Tylenol, and that helps, but he is still having symptoms that come and go and it has been 3 weeks since the second injection of the Pfizer covid-19 vaccine. He reports going to the ER for treatment after the second injection, and a COVID-19 test was negative and they did not find anything else other than the Pfizer COVID-19 vaccine that would be causing his symptoms. The events hasn't gone away, it's now about 3.5 weeks and he hasn't had a good day since then he has been experiencing chills and fever. It goes away for a couple hours, it goes away till around 9 or 10PM at night, then he is good at night, then in the afternoons around 2PM or so the fever kind of comes back and instead of chills he is getting warm flush, when taking his temperature he notices it ticks up. He is taking Tylenol every 6 hours. He would like to know if this is normal and have others reports this? The First time he experienced the chills and fatigue it was on 18Feb2021. Then the second time the chills, fever, fatigue, and nausea started on 15Mar2021. The events were described, "Fever: It is not as steady, when it ticks up, it is never going past 100F, it's been like 98 and 99, that's when he starts to feeling so bad. He provides todays temperatures, this morning 97.5F he usually runs low, then about 10AM 97.7, then at 11AM 98F, then an hour ago it was 98.8F and he can feel the difference. Nausea: It occurs when the temperature ticks up, it's not really nausea but its uneasiness in the stomach, not necessarily nausea but he feels no appetite. It has the Same pattern as the fever. Fatigue: Yesterday morning he got a blood test and he did not have a fever he was normal 97F, but he could barely take 10 steps, the fatigue varies, it does not coincide with the fever. Looking back over the 3 weeks, the fatigue is better now. On 21Mar2021 he went to the ER because he was feeling so bad, there was a little bit of wheezing and shortness of breath, they did lab work and a chest X-ray, they sent him home with an antibiotic and a steroid inhaler. The chest X-ray showed Bronchitis. Blood work results are Unknown. He clarifies that the ER sent him home the same day after 9 hours, he was not admitted to the hospital. When queried if he had a physician office visits he states that he had 2 "Tele-med" appointments with the Primary Care doctor. He has no Allergies. The outcome of the event fever and nausea was not recovered while the outcome of the event fatigue was recovering; and the outcome of the rest of the events was unknown.

Patient presented to a doctor's appointment with complaints of blood in stool as well as a sore arm ever since his COVID vaccination.

Woke up in the middle of the night dizzy on the evening of 3/11/21,started vomiting blood, syncope, when woke up had altered mental state, when reoriented he was able to call EMS, taken to hospital where he was diagnosed with an abdominal clot size of a grapefruit

patient reported having mouth sores after getting the vaccine. however, patient is on chemotherapy and getting mouth sores from chemotherapy so this is unlikely to be vaccine related.

23 Feb 2021: event: fainting spell, nausea, no prior warning 26 Feb 2021: doctor visit, fitted with heart monitor 1 March 2021: Doctor visit, readout of heart monitor showed no anomaly. 16 Mar 2021: event: fainting spell, nausea, no prior warning 30 Mar 2021: event: passed out in shower, EMT called, rushed to Medical Center, admitted to ICU 31 Mar 2021: treatment: pacemaker installed circa 1000 AM, 2 Apr 2021: released from Hospital xxx

Patient had vaccine on 4/6/2021 and on 4/8/2021 he went to the hospital for bright red blood from his rectum to the point of running down his leg. He was admitted to the hospital 4/8/2021 to 4/9/2021.

Dizziness; weakness; fever; tinnitus; chills; acid reflux; vomit; difficulty breathing; enhanced smells and taste; enhanced smells and taste; via unspecified route of administration in left leg; This is a spontaneous report received from a non-contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6198), via unspecified route of administration in left leg on 25Feb2021 08:15 AM (at the age of 79-year-old) at 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medications, it was reported that patient received any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Feb2021 the patient experienced dizziness, weakness, fever, tinnitus, chills, acid reflux, enhanced smells and taste, vomit, difficulty breathing. The events were reported as serious with hospitalization and life-threatening criteria. The patient was hospitalized on 14Mar2021 and duration of hospitalization was reported as 5 days (19Mar2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported that since the vaccination, the patient had been tested for COVID-19 with test type nasal swab (negative) and test type other with test name antibodies test to SARS-COVID 19 (negative). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

ED Discharged 3/28/2021 (4 hours) Hospital ED MD Last attending ? Treatment team Pneumonia due to COVID-19 virus Clinical impression Diarrhea ? Cough Chief complaint ED Provider Notes MD (Physician) ? ? Family Medicine Expand AllCollapse All Chief Complaint: Chief Complaint Patient presents with ? Diarrhea ? Cough CT of chest shows no pulmonary embolism but is positive for Covid pneumonia. Clinical Impression: Impression is Covid pneumonia. Patient looks well clinically stable sats look good no need for admission. He is taking steroids he has read the protocols and has steroids at home. I told him that the protocols usually are for inpatient I cannot really say with absolute certainty that this will do anything positive as an outpatient I think given how well he looks and not sure that he needs to continue that. Otherwise however return immediately if things worsen I will see him as an outpatient MD 03/28/21 1826

Patient with new onset of severe dizziness after his first COVID19 vaccine. Pt began having dizziness and then felt nauseated, weak, and diaphoretic. Patient left ED.

Temperatures 105; chills; confusion; unsteady walking needing, great assist; Severe pain in back and neck; Severe pain in back and neck; Not eating, taking water OK; Incontinent of urine and stool; Incontinent of urine and stool; This is a spontaneous report from a contactable (patient). A 79-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm on 04Mar2021 at 10:00 (at the age of 79-years-old), as single dose for COVID-19 immunisation. Medical history included aortic heart valve replaced, mild COPD, edema in legs, irregular heartbeat. Patient had no known allergy. Patient not diagnosed with COVID-19 prior to vaccination. Patient was not received any other vaccine prior four weeks of vaccination. Concomitant medication(s) included MELOXICAM, LASIX and HCTZ. On 04Mar2021 at 14:00 (same day after vaccination), patient experienced temperatures 105, chills, confusion, unsteady walking needing, great assist, severe pain in back and neck, not eating, taking water OK, Incontinent of urine and stool. Patient did not receive any treatment for the events. Since vaccination patient not tested for COVID-19. The patient underwent lab tests and procedures which included Body Temperature: 105 on 04Mar2021. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

after lunch he vomitted; stool is very liquid like; felt a little sick to his stomach; feel nauseous; This is a spontaneous report from a contactable consumer reporting for a 79-years-old male patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiration date was unknown) via an unspecified route of administration in right arm on 04Mar2021 at 17:15 as 1 ST DOSE, single for COVID-19 immunization. The patient medical history included cholestrol, blood pressure, light asthma, stroke in 2014 and allergies with bactrum, tapes and hydrocodone. The patient previously took bactrum t and hydrocodone and experienced drug hypersensitivity. It was reported that the patient did not take any vaccine in four weeks, he did not have covid prior vaccination and did not get tested for covid post vaccination. The concomitant medications included lansoprazole 30mg twice a day, clopidogrel 75 mg, lisinopril 20mg, metoprolol tartrate 50mg, evolocumab (Repatha)140mg injection pen, colecalciferol (Vitamin D) 1000 iu twice a day, fiber, cyanocobalamin (Vitamin B12), fluticasone furoate, vilanterol trifenatate (Breo ellipta) inhaler, fexofenadine hydrochloride (Allegra) and macrogol 3350 (Miralax) all taken for unknown indication, start date and ongoing status unknown. Approximately 1 to 2 hours after the shot on 04Mar2021, he felt a little sick to his stomach, during the night he felt bad but did ok. On the next day on 05Mar2021 he ate breakfast felt ok and after lunch he vomited and his stool was very liquid like. On an unknown date in Mar2021, he continued to feel nauseous. No fever just feels nauseous still on Saturday, after he eats he then has to vomit. Stool and vomit all have the same look. He was not keeping any food down but was drinking a lot of water. Just taking a lite diet, broth, toast, crackers, etc. Patient did not received treatment for the events. The outcome of events was recovering. No follow-up attempts were possible; information about lot/batch number cannot be requested.

Two weeks after the first Pfizer Covid-19 vaccine, the patient experienced vertigo-like symptoms with severe nausea, vomiting and diarrhea. He was admitted to the hospital where he stayed for a few days. After treating for vertigo, symptoms subsided. These symptoms have recurred several times since then. He was hospitalized again last week for several days. He also made another trip to the ER. Other times he was treated at home with prescribed medicine. He had symptoms of encephalitis. After multiple tests proved inconclusive, we now suspect this was an adverse event brought about by the first Covid-9 vaccine.

pronounced malaise including headache, slight nausea, muscle ache, shortness of breath, dizzines for three days followed by heart palpitations on day four. Palpitations continued for several weeks and then slowly cleared. BP, heart beat all normal. Palpitations were infrequent, then increased in frequency and the slowly diminished.

Wasn't felling heathy/Wasn't feeling well/not feeling good/Felling ill/Feeling sick; Using a bathroom number 2 four times a day, regular stool not soft; Back hurt; Slightly dizzy; I worry about how I am feeling until I know it is from the shot or not I am not going for another shot; Maybe nauseous; Feeling down; This is a spontaneous report received from a contactable consumer (patient) reported that: A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0123; Expiration date: unknown), via unspecified route of administration on 02May2021 (at the age of 79-year-old) as first dose, single dose COVID-19 immunisation. The patient medical history included atrial fibrillation and the concomitant medications included blood thinner for atrial fibrillation. The patient took pfizer shot 3 weeks ago. The patient experienced was not felling heathy, I wasn't felling a 100 percent; Was not feeling well/not feeling good, using a bathroom number 2 four times a day, regular stool not soft, back hurt, Feeling ill, Feeling sick, Slightly dizzy, worry about how he is feeling until he know it is from the shot or not, patient not going for another shot, May be nauseous, Feeling down on unspecified date in May2021. The patient stated that he got the shot 3 weeks ago and patient was due for second shot tomorrow but he have a concern, he do not think he is going for it, 2 days after he was not well about 8 days and then he felt better and then about 4 days ago he felt the same thing again, The patient stated that "he did not really care to report it but what he was calling to see his second shot is tomorrow and he is not going for it, but he would like get it may be when he feeling mentally after it, Could he take it couple of weeks later, if that ok?" the patient had a reaction to the flu shot (Unspecified Flu Shot) and he was feeling ill for about another 9 days it went away, but then it came back 4 days ago; didn't feel well/ not feeling good. The patient was scheduled for my second shot this morning I did not go because he is not feeling that great. The patient said he got the flu shot 3 weeks ago and 2 days after this shot, he did not feel well for about 7, 8, 9 days and then it went away, he felt okay and then about 4 days ago he got back the same feeling, not feeling good, slightly dizzy, maybe nauseous. Using the bathroom, number 2 frequently 4 times a day and he was scheduled for my 2nd shot this morning I did not go because he was not feeling that great. The patient stated that he took the vaccine three weeks ago and he was scheduled for his second shot this morning, he did not go because he is experiencing some side effects(Further not clarified hence captured as verbatim) and he was concerned to see this is related to the vaccine (confirmed as Pfizer COVID vaccine) or not?" He got this vaccine shot 3 weeks ago two days after he was not feeling well, he was feeling down for about 8 or 9 days and then it passed, the patient felt better then 4-5 days ago the same thing come back, this is 3 weeks now. The patient did not receive any treatment for the events, the outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Loss of breath, unable to stand, loss of memory, oxygen level became low, dizzy, weakness, blood pressure declined, diarrhea, vomiting, injection sight swollen, disoriented, shakes, was freezing, uncontrollable bowls, unknown substance coming from mouth, loss of strength in arm

Short of breath; I am having difficulty is shortness of breath; It's nauseating pain that I am having in my stomach; It's nauseating pain that I am having in my stomach; Very strong stomach discomfort; This is a spontaneous report from a contactable consumer reporting for himself. A 79-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 27Jan2021 (Batch/Lot Number: EL9261) as dose 1, single (age at vaccination: 79-year-old) for covid-19 immunization. Medical history included Blood pressure high from an unknown, knee surgery from 25Jan2021. Concomitant medication included clonidine 0.1 mg, taken for hypertension, start and stop date were not reported. On unknown date in 2021 (reported as couple days after I got my shot), the patient experienced "short of breath; I am having difficulty is shortness of breath, it's nauseating pain that I am having in my stomach, very strong stomach discomfort, And I can't shake it". Consumer stated, he had his COVID 19 Shot, first one and he think it was done last month on the 28th he believes (clarified as 27Jan2021). Because his next follow-up shot was going to on the 19th of this month that will be on 19Feb2021. And his symptoms were that he was short of breath and he was also having very strong stomach discomfort. And its nauseating pain that he was having in his stomach. And he could not shake it. And he doesn't know if there was something to do with the vaccine or something completely different. So, he was just wondering. He had gone through some lab test in last 2 weeks because he just had knee surgery, he had a knee surgery. And he that, his knee surgery was on the 25th of last month, it was 25Jan2021 when his knee surgery done. Lab test were apparently well, they were good, there was no reason for him not to have his knee surgery. He did pass COVID 19 nasal test for negativity, before the operation. And so, he had his blood work done and everything else was done before the surgery. Patient told the events were started couple days after he got his shot and was still experiencing. Patient did not take any medication for treatment because he doesn't know what it was. The only thing that was recommended to him was to eat some yogurt. The only other thing that he was having difficulty in shortness of breath, also that he noticed after getting the shot. The patient underwent lab tests and procedures which included blood test: unknown result, Lab test: they were good, sars-cov-2 test: negativity on an unknown date in 2021. The outcome for all events was not resolved. Follow-up attempts completed. No further information expected.

depressed; he was freezing and was shivering; he was freezing and was shivering; blood pressure was a little high; pulse was high; Nauseated; slept a lot; feeling tired; chills; high fever; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (Patient wife). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Lot Number: EN5318), intramuscularly, administered in Arm Left on 03Feb2021 08:00 as 1st dose, single for covid-19 vaccination (79 years old when vaccinated). Medical history included ongoing High blood pressure, additional Information for Other Conditions: Diagnosed years ago, ongoing CAC score high from 2018, ongoing urinary tract disorder from 2007- She said that he takes urinary medication, nephrolithiasis and also felt like it was like when he had a kidney stone. She said that he does not have a kidney stone. She said that he was really sick and hospitalized with the kidney stone. The patient's concomitant medications were not reported. Patient did not receive any other prior Vaccinations within 4 weeks Shingles vaccine, 2nd dose, No manufacturer or lot number at the time of the call, Intramuscular injection, Left arm 1 previous dose, given 2.5 weeks prior to the Covid vaccine at the beginning of Jan2021.It was reported that, Consumer called on behalf of her husband, who had his 1st dose of the Pfizer Covid vaccine last Wednesday morning (03Feb2021). He then started experiencing symptoms yesterday (on 04Feb2021) and last night he started feeling tired, had chills, high fever and muscle aches which was worried. She said that everything was ok until yesterday other than being tired, he had no reaction and no real soreness in his arm. Yesterday he was really tired and slept a lot and at about 20:30 he yelled out he was freezing and was shivering felt like it was like when he had a kidney stone, that he does not have a kidney stone. She said that his fever spiked really high, and he was treated with Tylenol and it came down. His highest temperature was 102. When he first got up this morning(05Feb2021), his temperature was normal, but within the next hour it went to 101.9 at 10:00, then to over 101, and then it came back down to 100. It maintained during the night, he had some muscle aches now, he was a little bit nauseated, but that has gone away also, and the Nausea did not last very long. The blood pressure was a little high and his pulse little high, but the blood pressure is better. His next appointment for his 2nd dose of the Covid-19 Vaccine is 24Feb2021. She said that he takes high blood pressure medication. urinary medication, and cholesterol medication. He had been a little depressed because of Covid and he is taking antidepressant medication, but it should be temporary. Therapeutic measures were taken Tylenol as a result of high fever, blood pressure was a little high, depressed. The outcome of the events Fatigue, chills and Nausea, feeling cold were resolved; for Fever, Muscle ache, pulse was high, Myalgia, Hypertension, Depression mood were not recovered, blood pressure was a little high was recovering was unknown. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

Burkitt's Lymphoma, Pain in Abdomen, Lethargy, Weight Loss, PET Scan, Chemotherapy, Mass discovered in Lymph Node in abdomen CT Scan - May 18, 2021 Blood Work - May 19 and 27, 2021 Tissue Culture and Biopsy - May 19, 2021 PET Scan - May 27, 2021 Echocardiogram - May 28, 2021 Chemotherapy start date - June 2, 2021

Diarrhea; He was sick; Vomiting; This is a spontaneous report from a contactable consumer. A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 25Jan2021 (age at vaccination: 79 years) as DOSE 2, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 06Jan2021 as dose 1, single for covid-19 immunization. On 07Feb2021 02:30, the patient experienced diarrhea, vomiting and was sick. The reporter stated that on Sunday morning at about 00:30, he woke up and he started having diarrhea and about 2:30 am, he started vomiting, he was sick all day long yesterday and he is still sick this morning. The reporter got to go through all his paperwork and all and it said was that this could be some symptoms of the COVID Vaccine. The outcome of the event illness was not recovered, and all the other events was unknown. Follow-up attempts completed. No further information expected.

79 Male received both doses of Pfizer. Developed symptoms - SOA, decreased activity, generalized weakness, decreased P. O. intake. Tested PCR positive 4/26/2021 & serology 4/29/2021. Hospitalized 4/27/2021. Diagnosis at time of death: Hypoxic ARF requiring MV, COVID-19 PNA, rule out superimposed bacterial PNA, renal failure, oliguric, metabolic acidosis. CWP/COPD exacerbation, CAD, DM present on admission

Nausea, H/A, took 2 Tylenol. At 10pm started feel ill, achy, Had trouble breathing over night. The albuterol didn't help. Heart beat was fast. 1/13/20 in the am had a H/A, took 2 Tylenol. The breathing got better around noon.

Tiredness, loss of appetite, coughing, nausea, Arm ache, excessive thirst, some sweating. NO high temperature.

Patient's wife called this morning stating that her husband has passed away last night. After receiving first dose of Pfizer COVID-19 vaccine at around 0830, patient remained in the Immunizations Department for the 15-minute monitoring period. Per wife, patient's only complaint was pain at the injection site. At 1300, wife states that patient complaint of dizziness which "dissipated after a few minutes" followed by a headache which "dissipated after a few minutes" as well. Then patient complained of nausea, no vomiting and "couldn't relax." Per wife, from around 1400/1500, patient stayed on his recliner while still having a conversation with her--"he didn't get up to eat." Last conversation they had was around 2000/2100. Per wife, at around 2100/2200, patient was quiet and when she checked on him, "he wasn't responding anymore." Wife then called 911, "but they couldn't revive him."

Acute Gastrointestinal Bleeding per rectum with massive bloody diarrhea, transfer to Emergency room by EMS with IV placement and fluid resuscitation, vital signs unstable, emergency assessment and massive transfusion over next 4 hours of 4 units of PRBC and 2 units platelets, dual 16 gauge IV's, intrarterial line. ER Summary available and can be scanned and sent. Low HgB, Low platelets in 60 k range and multiple consultants and diagnositcs

Extreme muscle weakness, could not get out of bed unassisted, slight nausea. After 48 hours symptoms went away rapidly. Never had a reaction to a vaccine previously. Have had flu, shingles, pneumonia previously..

Patient had his first vaccine on 1/12/21. On 1/13/21 and 1/14/21, he was more confused then normal, very emotional, and has decreased appetite. Patient recieved the second vaccine on 2/2/21. On 2/3/21, he was once again more confused, emotional, and had little appetite. He is now back to normal.

irregular hearbeat; Belching; Gas; Stomach cramps; felt antsy; his blood pressure went up the day he hook the vaccine to 200/93; He was anxious feeling; sharp pains in his right eye; Ears Felt Funny; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiry date not reported), via an unspecified route of administration on 19Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included high cholesterol and blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication included propranolol hcl for blood pressure and an unspecified cholesterol pill. The patient previously received influenza (Flu shot) on an unspecified date (years) ago for immunization and experienced light headed. The patient reported that his blood pressure went up the day he hook the vaccine to 200/93 and he was real concerned about that. He took a blood pressure pill and was having some sharp pains in his right eye (he had 3-4 at different times). He was anxious feeling and could hear it blowing in his ears (which happens when his blood pressure is high). He stated he has never had his blood pressure that high and has never had any heart problems. The patient asked, whether he was in the danger zone, the danger zone of having a stroke and if they should take their second dose. The patient wondered if they could just take the first dose only. It was further reported that he took the vaccine yesterday or the day before (19Jan2021) at 11'o clock. He didn't have any problems, he just got home. Then 11'o clock at night he had fallen asleep during the day and woke up at that time, 11'o clock and he felt Antsy, his blood pressure was up, his ears puffed real high, he's on Blood Pressure medication. He Clarified further that his First Dose was on 19Jan2021 at 11 o clock during the day. Then 12 hours later that same day, he woke up, and that's when he felt antsy and the blood pressure being up. Normally he takes his Blood Pressure 2-3 times a week but that day it was like 190/80 something. When he saw it, he sat down, and thought if he relaxed it would go down. He went back over in 45 minutes or an hour later and it was 200/93, he thought he had sharp pain in the right eye during that time as well. He Never had that before, he had pain in eye before, but not like this. He then told himself maybe he should take a blood pressure pill, because he was concerned he didn't want to stroke out. He took a Blood pressure pill and then relaxed for an hour later he checked it was 189/82. He waited some more, and it kept coming down. He stayed in the recliner all night. Then on 20Jan2021 he checked and it slipped to 140/55 at about 5 o clock. The Blood pressure kept coming down 10 to 15 points every hour. The last one he took later that day was 118/65. He explains that his Blood pressure normally runs 120/65 to 140/70 normally. His blood pressure medication is only 10mg, its a low dose, he is a Healthy Person, he walks every day, his weight is good. The blood pressures provided were from 11AM to 11PM at night of 19Jan2021. It was the same day when he felt the ears feeling funny, and the sharp pain in the right eye, he has never had that before. He also forgot to mention that the next day he had a lot of stomach irregularities , he had cramping, it was uncomfortable, this was on 20Jan2021, he was also belching, and had gas. It went away that evening lasting 4-5 hours, it started in the morning 10 o clock went till 3 or 4PM. The BP value of 140/65 was from today, before lunch. The right eye sharp pain went away during the night, after he took his blood pressure pill, he didnt notice it anymore after. He doesn't know if the vaccine caused this. He couldn't tell any difference even with the pain. The ears feeling funny, he took his blood pressure a couple times a day. The monitor is showing an irregular heart beat, he didn't notice that before. He has had no positive COVID test or Antibody Test prior to the vaccine. The patient recovered from sharp pains in his right eye, ears felt funny on 19Jan2021, stomach cramps, belching, gas on 20Jan2021 while the outcome of the rest of the events was unknown.

Blood in stool; 36 hours after receiving his first dose of the COVID-19 Vaccine (at 4:00PM), he had massive diarrhea; This is a spontaneous report from a contactable consumer (patient). An 80-year old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 13Jan2021 07:00AM (vaccine location: Arm, Left Upper) at single dose for COVID-19 immunisation. The patient's medical history included ongoing parkinson's disease (probably had Parkinson's disease for 8 years, but was formally diagnosed 6 years ago) and peripheral neuropathy. The concomitant medications was reported as sinemet for parkinson's disease and gabapentin for peripheral neuropathy, about 6 years. Patient said 36 hours after having his first COVID-19 Vaccine dose, he had massive diarrhea on 14Jan2021 at 04:00PM. He said the diarrhea only happened one time. He said he went on a BRAT diet for a few days and then back to a regular diet. He clarified the diarrhea was brown. He said he had 1 incident of blood in his stool after that on 15Jan2021. He said he couldn't get an appointment with his doctor, so he went to emergency room. He said he was at the emergency room from 8:00AM-4:00 PM. He said the emergency room doctor told him he probably didn't have any recurrence of blood in his stool, because the blood was caused by his episode of diarrhea the day before. He said the emergency room doctor postulated that his diarrhea was caused by the COVID-19 Vaccine because there was a 36-hour delay between receiving the COVID-19 Vaccine and having diarrhea. The outcome of diarrhea was recovered on 14Jan2021. The outcome of blood in stool was recovered on 15Jan2021. No follow-up attempts are possible. No further information is expected.

Roughly 9 hrs after shot malaise. During next 30 hours loss of balance, incontinence, nausea, mild headache. By 40 hours symptoms had diminished and I could eat, although sparingly, again

At 1200 it was noted resident had a small emisis. Resident responded minimally to this writer verbally and does track writer with his eyes. Respirations are noted to be labored. Respirations 32. Mouth cleaned, no obstruction noted. Oxygen applied via nonbreather at 5L. Temp 91.3, pulse weak and thready, BP 98/50 on R)arm, Pulse 90. Resident is very weak, pale diaphoretic. Resident shaking and jerking. Initially unable to obtain pulse ox. Emergency services contacted. At 1212PM BS 135 BP to R)arm 108/68, Sats 99% on 5L nonrebreather, respirations are even and unlabored 18. Resident is noted to open eyes and communicate. Dr.is notified and okays sending resident to ER. Wife notified of pt condition by staff she will meet at ER. EMS arrives and transports resident to ER 1223 and RN gives report to the ER.

Patient reported to Emergency room on 01/23/2021 with complaint of nausea. According to ER record patient reported he received a COVID 19 vaccine Pfizer the day before. Work up in the ER (CT ABD PELVIS) reveal a clotted of SMA. CT CHEST REVEALED BILATERAL PULMONARY EMBOLUS. THE PATIENT WAS TRANSFERRED TO THE STATE HOSPITAL. HE WAS SCHEDULED FOR EMERGENT VASCULAR SURGERY WHICH WAS CANCELLED AS THE PATIENT DIED SHORTLY AFTER HIS ARRIVAL.

Immediately he had a headache associated with dizziness and the headache persisted. He was known to be unstable on his feet with muscle weakness. Other complaints include shortness of breath, confusion, decreased appetite. O2 saturation dropped from 90% to 80% on room air. He complained of low back pain and weakness and heart rate of 115.

Per Patients Wife - Same day - Flu like symptoms, Nausea, Headache. Restless that night. Next day - Weak, shortness of breath. Wife called squad to get him out of his wheelchair but patient refused hospital as it gets him agitated. Patient passed away around 11 AM the day after vaccination.

In the mid-afternoon of the day of the vaccination (Feb. 24, 2021) I developed something that felt to me like heartburn which I do not normally have. Its location was mid-chest (near the heart). It was moderate at first but became more intense with time. By around 6 PM, Feb. 24, the pain was still building, but had migrated lower in my torso closer to my stomach. The pain reached a peak around 3 AM, Feb. 25, 2021. and from that time kept diminishing until it was essentially gone by about 6 PM on Feb. 25, 2021. Even at its worst, the pain was not so intense that I felt I needed medical treatment. I always felt during this episode that the pain was completely manageable.

patient presented to ED with chest pain, gone upon arrival to ED, dyspnea on exertion, shortness of breath. no congestion, no cough. Nausea present. patient tested for covid and found to be positive. Received 2nd covid vaccine on 2/3/21

10/5 :Fri 2:00 PM Nausea,9:30 PM Fell down and could not get up without assistance, unable to walk or setup, Dizzy and confused, bad itchy rash on body including large red spots(stomach, back, legs, arms, head , neck) Sat 10/6 admitted at Hospital tests results dehydration. Continued problem with walking. Tues 10/9 visit with primary doctor. Pictures were taken of his body and entered in computer at Clinic. Walking issues getting better.

within minutes I began coughing, this lasted until after midnight with heavy mucus with gaging and coughing. I took Mucinex a sleeping pill and got some sleep. The next day got up for breakfast and went back to bed sleeping and still groggy at 4 p m

mild difficulty breathing; swelling lymph nodes; feels like he got the flu; nausea; pain at injection site; headache; tired; Low Appetite; This is a spontaneous report received from sponsored program , from a contactable consumer (patient's son). An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date in Feb2021, as single dose for COVID-19 immunisation. After receiving the first dose of the BNT162B2, approximately in Feb2021, the patient experienced pain at injection site, headache, swelling lymph nodes, nausea, tired, mild difficulty breathing and low appetite. He also felt like he got the flu. The patient's medical history and concomitant medications were not reported. It was informed to reporter to consult HCP since his father was experiencing mild difficulty breathing which require immediate medical attention. All the other side effects except low appetite have been reported with the BNT162B2. The vaccine might vary person to person the side effects listed are not different from one dose to another. These side effects could occur with either dose. The duration of the symptoms is undetermined and asked him to consult his HCP if symptoms worsen or don't go away. No treatment was received for the events. The outcome of the events was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.

Fatigue, temp elevated approx 1.2°, no appetite, most of the day following vac. (3/11) Normal temp, slight fatigue, on 2nd day (3/12) All normal by mid- 3/12. No healthcare sought. (Spouse only.)

Patient, of 80-year-old male, with significant past medical history of hypertension, paroxysmal atrial fibrillation, hyperlipidemia, coronary artery disease s/p stent, and BPH. Patient comes from urgent care after being found hypoxic. He refers that for the last 3 weeks felt weak, with loss of appetite and poor oral intake. He went to a to the urgent care to get it evaluated and he could get some IV fluid because he felt dehydrated. Patient refers that in the past when he gets severely dehydrated had episodes loss of conscious and this time he wanted to avoid that. He states that on February 4th got tested positive for COVID-19 because his fiancee tested positive the previous day. He quarantined and was asymptomatic. On February 27nd got first dose of COVID-19 vaccine. But since he tested positive feels that has no energy. Besides this patient denies fever chills shortness of breath, chest pain, abdominal pain, diarrhea nausea, vomiting, headache, lightheadedness, loss of sense of smell or taste.

Soreness at site of injection, slight headache and nausea, general body aches and pains. Lasted for two days then subsided. Temperature 100.7 degrees F at 7 AM on 04/16/2021 declined to 97.6 degrees F. by 4 PM 04/17/2021 (normal for me)

4/12 Patient was brought by family to ED for excessive fatigue, dry cough and poor PO intake. He was positive for SARS CoV-2 and had some hyponatremia. Date of onset of symptoms: ~Approximately 5 days Date of covid positive test: 4/12/21 Symptoms: dry cough and fatigue Imaging: Chest x-ray?No significant abnormality Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: not indicated Of note it has been reported the patient is approximately 2 weeks out from second Covid vaccine injection. His son reports that one day about 2 weeks ago he escaped out of his home into a crowded bar and apparently there were 7 others there who tested positive. . Appreciate Dr's assistance - reswab sent for CT value. CT values were 18.5/19 which are consistent with concern for active disease. He was given monoclonal antibody in-house on the day of discharge

Could not sleep for two days; Sweaty; Chills; Face and palms got really red; Indigestion; Constipation; deathly sick over the weekend; This is a Spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EM6207), second dose via an unspecified route of administration, administered in Arm Left on 20Mar2021 15:00 (Batch/), single dose for covid-19 immunization. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing Diagnosed with COPD 3-4 years ago and is not taking any medication for it, (blood pressure) hypertension from an unknown date and unknown if ongoing had been taking Atenolol for blood pressure. Concomitant medication included atenolol. The patient had the first dose of bnt162b2 vaccine (Lot EN6023) on 27Feb2021 for covid-19 immunization and experienced hypertension aggravated. He went back to doctor and had been taking Atenolol for blood pressure. It has always been dose 50/25. His blood pressure was up just a bit and he cannot verify who this girl was that changed it to 100/25. He did not like the way he felt and eliminated it and went back to the previous dose. He had two over a period of 2-3 days. It is in a pharmacy vial. He does not have a lot or expiration for the Atenolol 100/25. The date his blood pressure was up was for the past couple of times.Usually, it is 120/60-70 and then it jumped up to 150/60-70 and that is why it needed to be changed. It was filled on 18Mar2021, which was after first vaccine but before second dose. Patient got deathly sick over the weekend on 02Apr2021. He had the shot on 20 Mar 2021, and it has been more than the two days you could have a reaction. He was deathly sick. On 02Apr2021, he had just about all of the symptoms; sweaty, chills, face red, and hands red, indigestion, constipation and could not go to the bathroom. He was about as sick as he had ever been. He know it is not supposed to be that long. He could not sleep for two days. His face and palms got really red. He did not have a fever. He walked the floor and only slept 2 hours in two days. On 31Mar2021, he goes to a pain center and got shots in his neck. He asked the doctor if his shot had anything different than he had been getting and he confirmed that it was no different. He never had a reaction before the one he got on 31Mar2021, and thought it may have been the virus shot. He said one other thing happened and is not sure if it had anything to do with it or not. He just started to feel worse and worse. Today is the first day he felt better. He is 80 and has not been this sick. It got really bad but today it is much better. He did not sleep for two days and last night he slept and feels better. For the indigestion, it got worse before it got better. For constipation, he got relief last night and that is why he feels better today. NO ER or physician's office required- He had a previously scheduled office visit for pain center. The outcome of the events was recovering. The event insomnia was assessed by the reporter as medically significant. Information on Lot/Batch number was available. Additional information has been requested.

Presented to ER via private vehicle with complaints of general malaise, weakness, "not feeling good" beginning the morning before (04/16/2021), complaints not more specific. Associated symptoms included encephalopathy, lethargy, anorexia, progressively unsteady gait. Wife denied nausea, vomiting, diarrhea, fever, bloody stools, difficulty/painful urination. Diagnosed with thrombotic thrombocytopenic purpura with an initial hemoglobin of 4.8g/dL, hematocrit 14.2%, platelet count 6000uL, PT 12.2sec, INR 1.2, BUN 75mg/dL, creatinine 2.4 mg/dL, total bilirubin 3.3 mg/dL, direct bilirubin 0.60mg/dL, troponin 3.81ng/mL, and ADAMTS13 activity <2.0. He received 2 units PRBC, 2 units platelets, and plasmapheresis was initiated. As of today, he has had 5 consecutive days of plasmapheresis. Repeat laboratory evaluation this morning hemoglobin 8.8, hematocrit 28.4, platelet count 97000, BUN 35, creatinine 1.5, total bilirubin 1.3. Now awake, alert, and oriented. Eating and ambulating with physical therapy

Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild

Patient is a 80 y.o. male with significant PMHx of CAD, HTN, HLD, CKD who is admitted to ICU as a transfer from hospital for acute liver failure and cardiac arrest. Pt presented to hospital on 04/28 w/ complaints of nausea and vomiting. He stated that he had recently gotten his COVID vaccine. Pt was found to be in acute liver failure in the ED w/ AST and ALT > 1000. Lactate > 15.0. BMP showed AKI on CKD and BG >500. Pt did have cardiac arrest while undergoing CT Scan and ROSC was achieved after CPR x 20 mins. Pt was hence transferred to the ICU for higher level management and admitted for cardiac arrest and acute liver failure. Upon arrival, Pt was intubated and sedated. He was non-responsive to verbal and physical stimuli. Pt was acidotic. ABG: 6.99 / 28 / 165 / 7. 1 amp of HCO3 was given upon arrival. Pt was started on insulin gtt for DKA and was started on Levophed for low BP. Pt underwent cardiac arrest shortly after arrival to the ICU. CPR was performed for > 20 mins without ROSC. Family arrived at bedside and decision was made to stop CPR at 0205 on 04/29/2021.

Diagnosed with COVID-19; Diagnosed with COVID-19; Nausea; Tired; Unable to eat; Diarrhea; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Feb2021 (15:15) (Lot number: EM9809; Expiration date was not reported) and the second dose on 01Mar2021 (Lot number: EN6203; Expiration date was not reported), both on the right arm as a single dose, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included myasthenia gravis and diabetes. The patient had unspecified concomitant medications. On 05Apr2021, the patient had nausea; was tired; unable to eat; and had diarrhea. On 10Apr2021, the patient was diagnosed with COVID-19 (tested positive for SARS COV-2 RT-PCR nasal swab). The events had resulted into doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The patient's computerized tomogram (CT) value was 16.1-33.0 on an unspecified date. The outcome of the events was not recovered.

Reaction was more intense, but of shorter duration than the reaction to the first shot on 4/15/2021 (lot # ER8729) I experienced weakness, dizziness and remained in bed until 5 PM on Saturday 5/8/2021, the day after the shot. This time, there was no pain, swelling, or redness at the shot location on my right arm. I experienced a loss of appetite, slight headache and some groin aches through most of the day on Saturday. I'm feeling much better today, Sunday 5/9/2021. Side effects from the first shot lasted a full two days

About a day and an half after the injection patient had a sudden onset of extreme nausea, vertigo and vomiting. After 1.5 hours of vomiting, he was taken to the hospital by ambulance and was admitted for four days. CAT scan and MRI, ECG and bloodwork ruled out stroke, heart attack etc. The hospital administered anti nausea medications (meclizine sp?). The nausea resolved about 8 pm.

Altered mental status, confusion, subdural hematoma. Was lifeflighted to Clinic and remained there about 5 weeks, developed a stage IV pressure ulcer on buttock. Diagnosed with multi organ failure. Went to a SNF for rehab after being discharged. Wife said then patient received 2nd dose of vaccine about 2 weeks ago and is currently at Hosptial in town for a GI bleed, passing frank blood and clots. He was admitted 5/9/21. Patient is still confused and lethargic. Before the vaccine, he was taking care of his farm and home. Now he doesn?t even know his wife or what is going on.

Office Visit 3/27/2021 PA-C Family Medicine COVID-19 Dx Cough ? Sore Throat ? Poor Appetite 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 80-year-old male presents with URI symptoms. Rapid Covid testing house was positive. Patient has had his first dose of Pfizer SARS-CoV-2 vaccine and is due for his second and final one in 7 days. Patient was advised to follow-up with PCP today to discuss monoclonal antibody infusion. Strict supportive care and isolation instructions reviewed in detail. ED precautions reviewed with patient. 1. COVID-19 Patient was seen today for cough, sore throat and poor appetite. Diagnoses and all orders for this visit: COVID-19 - POCT COVID-19 Antigen Clinical Support 3/30/2021 RN COVID-19 virus infection Dx Encounter Notes All notes Progress Notes from RN Instructions COVID 19 Monoclonal Antibody (MAB) Infusion Patient Reference Guide MAB Infusion Treatment Team: Primary Care Physician: The physician that referred you for the infusion and who will conduct the follow-up appointments related to your infusion. COVID-19 MAB Navigator: The person who will schedule you for your infusion, ensure your follow-up appointments are scheduled and that you have all the necessary tools to track your health. COVID-19 Navigator Contact Information: MAB Infusion Follow-up Plan: Day of Infusion: o You will be discharged from the Infusion Center to home. o You will begin recording your temperature and oxygen levels (pulse ox). You will receive prompts from the monitoring program you selected. Follow the prompts for when to record your temperature and pulse ox. Day 2-3 after Infusion: o You will receive a follow-up call from the COVID-19 Navigator to schedule your 7-day follow-up video visit with your Primary Care Physician. Day 8-14 after Infusion: o You will receive a follow-up phone call to assess your overall health. Day 15 after Infusion: o You will receive your final call from the Navigator, and you will graduate from the Infusion Program. You will resume your routine appointments with your Primary Care Physician. When to call your Primary Care Physician: o Please call your Primary Care Physician if you have pre-existing health conditions that you feel need medical attention and are unrelated to your COVID-19 diagnosis and symptoms. o If you are experiencing non-life threatening COVID-19 symptoms and have additional questions. When to call the COVID-19 Navigator: o Please call the COVID-19 Navigator if you have general questions regarding the infusion you received today, questions concerning follow up appointments, or home monitoring procedures & equipment. o You should receive a follow-up phone call from the Navigator within 2-3 days of receiving your infusion. o If you do not receive a follow-up phone call, please call the Navigator. When to call 911 or Proceed to the closest Emergency Department: If you are experiencing life threatening COVID-19 symptoms including but not limited to: high fever, trouble breathing, persistent pain or pressure in the chest, new confusion, inability to wake or stay awake, blueish lips or face.How to Improve Your Breathing with COVID-19 Try to spend as little time as possible flat on your back! The largest part of your lungs are in the back of your body. When you lay on your back this causes fluid to pool in those parts of your lungs making it harder to breathe. Laying in different positions or sitting up will allow all the different parts of your lung to expand properly. You may notice it is easier to breathe immediately or soon after changing positions. One of the best positions for this is called 'prone position' which is laying face down on your belly. This position makes it easiest for the biggest parts of your lungs to expand easily. This is called 'proning' and the more time spent proning the happier your lungs will be. Laying on your sides or sitting up in a chair is also helpful for breathing and changing positions helps keep your skin healthy. Tips to Help with Repositioning ? Try placing pillows under the chest, hips, and lower legs when lying face down ? Trying different arm and leg positions can assist with comfort ? Eat your meals sitting up in a chair when possible ? When laying on your side, a pillow behind you will help you not to roll on your back if you fall asleep ? If a position is too uncomfortable move on to another; comfort and rest are important parts of recovery ? Switch positions in a rotation to help all the areas of your lungs expand After Visit Summary (Printed 3/30/2021) Additional Documentation Vitals: BP 158/83Important (BP Location: Right arm, Patient Position: Sitting) Pulse 58Important Temp 36.9 °C (98.5 °F) SpO2 95% More Vitals

Office Visit 3/23/2021 Urgent Care PA-C Family Medicine 2019 novel coronavirus disease (COVID-19) Dx Covid-19 Screening Reason for Visit Progress Notes PA-C (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 3/23/2021 ? ? Signed Cosigned by: MD at 3/24/2021 4:39 PM Expand AllCollapse All MDM Number of Diagnoses or Management Options 2019 novel coronavirus disease (COVID-19): Diagnosis management comments: Patient is an 80-year-old male with history of atrial fibrillation and positive POCT COVID-19. 6 days of symptoms. Excellent candidate for antibody therapy. The health system treatment navigator was notified of this and will schedule him for antibody infusion treatment. Patient is stable at present with no severe or concerning symptoms at this time. Tylenol/continued Eliquis recommended. Clinical Support 3/24/2021 Health system RN COVID-19 virus infection Dx Progress Notes RN (Registered Nurse) ? ? Encounter Date: 3/24/2021 ? ? Signed 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 ED to Hosp-Admission Discharged 3/25/2021 - 3/26/2021 (39 hours) Hospital MD Last attending ? Treatment team COVID-19 Principal problem Chronic anticoagulation Persistent atrial fibrillation (CMS/HCC) COVID-19 Confusion Hypoxemia Hospital Course: In his hospital stay we managed his medical issues as follows; Confusion/Syncope in the setting of COVID-19 infection Chronic atrial fibrillation/sinus node dysfunction Hypertension Prediabetes Patient received first dose of vaccination on 3/16 and afterwards started having muscle aches and body pains, later on found out to be having Covid 19+ test, he might be having Covid infection before vaccination as well and symptoms showed with vaccination. On 3/24 he was found out to be having confusion, family called EMS. They tried to debride patient on his feet and he collapsed for about 10 seconds. He did mention that he usually get dizziness/lightheadedness upon standing from bed. Although patient has a history of A. fib but remained rate controlled during hospital stay, we held his antihypertensives including HCTZ and ARBwhile continued his Eliquis. I believe his syncope was likely due to dehydration with decreased oral intake in the setting of acute illness with COVID-19 symptoms. Before discharge is blood pressure was rising so his ARB were restarted while decision regarding HCTZ will be made by primary care physician. In regard to his COVID-19 infection, initially was started on 2 L of supplemental oxygen but his oxygen demand decreased rapidly and most of the time he remained room air, he was not showing any dyspnea, cough, fever or any other generalized symptoms of Covid 19 infection. He did get plasma and remdesivir while inpatient, decision was made to discharge him on 3/26 as patient was symptom-free. He also had received first dose of vaccination. I believe that he would need further remdesivir. We will continue him on steroids for now after completion of dexamethasone for next 8 days he can recent resume his home medication of prednisone.

dizziness; weakness; fatigue; loss of appetite; shortness of breath; This is a spontaneous report from a contactable Nurse. An 80-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL1284, Expiration date was not reported), via intramuscular, administered in left arm on 14Jan2021 15:00 as first dose single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), atrial fibrillation (A-Fib), coronary artery disease (CAD), hypercholesterolemia, GERD, benign prostatic hyperplasia (BPH) and peripheral vascular disorder (PVD). The patient concomitant medication was not reported. Patient did not receive any other vaccine in four weeks. Patient received other medications in two weeks. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. Resident within 15 minutes of vaccination complained of dizziness, he then subsequently had other symptoms of weakness, fatigue, no fever, loss of appetite, shortness of breath on 14Jan2021 03:15 AM. Patient received treatment of prednisone. The patient underwent lab tests and procedures which included nasal swab test: negative on 03Feb2021. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Arm soreness after each dose was given/ Severe pain in legs; was 187 pounds and now down to 170; fell and busted his spleen; fell and busted his spleen; started peeing; developed blisters in his mouth and on his tongue; developed blisters in his mouth and on his tongue; Vaccination facility staff made a mistake resulted that the patient received the third dose of Covid-19 vaccine; mouth was also full of saliva, started slobbering and couldn't stop; Pain in shoulder/ Severe pain in joints; Severe diarrhea; having problems with words; had some problems with his balance; couldn't hardly walk because of his balance; Has no taste of food; Mouth Burning; break out with bumps around mouth; Scrotum blood blisters; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in left arm on 17Apr2021 (Batch/Lot Number: EW0171) as 3rd dose, single for covid-19 immunisation. Ongoing medical history included diagnosed with vertigo 5 years ago but had vertigo long before that, diagnosed with COPD, emphysema, asthma 12 years ago, Congestive heart failure after having a heart attack in Nov2018, stomach problem (had gastric bypass back in the 80's), had Pacemaker in 2020. Patient does take medications, but is unable to provide details. Patient received flu shot in Nov2020. No Prior Vaccinations within 4 weeks. Patient had first dose on 02Feb2021, second dose on 05Mar2021, and Vaccination facility staff made a mistake resulted that the patient received the third dose of Covid-19 vaccine on 17Apr2021. He had gone to Vaccination facility to get a B12 shot and the staff messed up and gave him the Covid-19 vaccine. He states he had arm soreness after each dose was given. On the night of 17Apr2021 after the third dose, pain in his shoulder began, the pain lasted about 3 days and had intensified a little more from the previous dose of the Covid-19 vaccine. When he woke up on 21Apr2021, his mouth was also full of saliva, he started slobbering and couldn't stop. On 22Apr2021 or 23Apr2021, he began experiencing severe diarrhea he began and having problems with words, he knew what he wants to say but it just doesn't come out. About 23Apr2021 or 24Apr2021, he began experiencing problems with his balance. He had vertigo for a long time and has always had some problems with his balance, couldn't hardly walk because of his balance, but the problems with his balance have intensified to where he needs someone to help him stand up now. On 24Apr2021 when he first gets up in the morning, he developed blisters in his mouth and on his tongue. On 27Apr2021 he began having problems with control, and started peeing all over himself, he didn't take his water pill on 27Apr2021 because he was going out and he still peed all over himself, he has been wearing adult diapers so that he doesn't mess himself again. On 04May2021 night, he fell and busted his spleen. And on an unspecified date in Apr2021, has no taste of food, Mouth Burning and break out with bumps around mouth. Scrotum blood blisters. Severe pain in legs and joints. He was 187 pounds and now down to 170. Patient received fourth injection on 21Apr2021 in left arm, but he is unsure if he received a B12 shot or something else. Attempts were made to clarify if the patient received 3 or 4 doses of the Covid-19 vaccine. Patient had blood tests, an EKG, and X-rays with unknown results, his heart looked good. The outcome of events was unknown.

Muscle ache, loss of smell and taste The PUI started feeling ill on 4/29/21 with minor symptoms. The patient is having body aches and a loss of appetite due to his loss of taste/smell. The patient is currently undergoing chemo therapy and is most likely the reason why he still got sick with COVID-19 even though he is fully vaccinated. Cause of Death: ACUTE HYPOXIC RESPIRATORY FAILURE, COVID 19 PNEUMONIA

Patient received second COVID 19 vaccine 5/15/21. Patient presented to the ED on 5/17/21 with cheif complaint of increased shortness of breath and weakness. On 5/16/21, he did not sleep well and felt sweaty with chills. He took ibuprofen and Tylenol. He states he feels like he has no power when he walks. No chest pain. No fevers. He also notes slight diarrhea. Patient denies any Covid contacts. There are no other modifying factors or associated symptoms

slight headache; Tiredness; Joint pain; Chills; hands were shaking; Fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration on 28Jan2021 at 15:00 as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient said he was calling about the Pfizer shot that he got yesterday (28Jan2021) at about 3pm. He stated he experienced some of the stuff they have on the list. He got the shot around 3PM and around 7PM that evening he started having chills, his hands were shaking really bad so he covered himself up really good and once he got some warmth to his body and about an hour later the chills calmed down and he started getting a fever his temp, the highest it got was 101.3 and it did come down after all night. He had a cold rag on his head the whole night. He had some joint pain, headache and tiredness, the headache was not severe. He had some diarrhea he does not know if that is associated with that or not. He did have some food, he ate that so he doesn't know if that is the cause of the diarrhea but it would not have caused all the other symptoms. He didn't have any redness where they gave the shot at all everything was fine on that end but he figured he better call to report it since he seen these are on the list. It was reported that slight headache was pretty mild now and it was not severe, he could just feel it in there but it is pretty much gone right now. Diarrhea went through the night and in the morning. He went 3 different times but now he thinks he is cleared out and needs to get some food back in him. His card says Pfizer COVID 19 vaccine. He does not see an NDC number or expiration date. He saw healthcare clinic site. Patent received vaccine because wants to be protected like all the other seniors. He went through night and that was pretty bad but he was starting to feel better now. He was tired it drained him he still feels pretty out of it but he is starting to feel better. He asked is there any concern about any of this stuff. He said everything was starting to quiet down now he doesn't think that would be necessary unless he had a relapse and he does not think that would happen at this point. The outcome of the event chills was recovered, slight headache was recovering and outcome of the other events was unknown. Follow-up attempts are completed. No further information is expected.

Within one week of vaccine dad lost interest in everything, developed incontinence, became extraordinarily sleepy, stopped gregarious talking and only responded to questions asked, became extremely confused, eventually losing his ability to walk, talk, and swallow. All occurring in short order. ER twice, hospitalized twice, rehabilitation twice. As yet, no formal diagnosis despite three hospitals seeing my father and testing him extensively.

crying; feeling nausea; depression; feeling dizziness; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17May2021 09:00 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunization. Medical history included heart valve replacement from 12Mar2021, kidney infection, had a heart bypass and is diabetic. The patient has no concomitant medications. The patient got the Pfizer Covid Vaccine on 17May2021, and the next day (18May2021) he woke up with dizziness. The reporter asked how long the symptoms last after the Covid vaccine. He is sort of getting nausea when he tries to get up. He was also real depressed. It kind of started the next day after the vaccine (18May2021), but Wednesday she was concerned because the patient was crying a lot which is unusual for him. The nausea started today (25May2021). He hasn't been up and about. The dizziness is about the same. They called his primary caregiver who started him on some antidepressants. She picked up the information sheet that was given to them with the Covid vaccine and read there that dizziness was a side effect and a feeling of impending doom which is sort of how he was feeling. Now that's why she was wondering when the symptoms would be over. She doesn't really think he needs anything. He has never been depressed. She thinks now it is a side effect from the vaccine. She thinks the depression has improved. He is not crying anymore, but somebody is with him all the time. This was his first dose of the vaccine. He is supposed to go back on 07Jun2021 for his second. The outcome the event depression was recovering, event crying was recovered on an unspecified date and the other events was not recovered.

Vertigo type feelings; Woosey and a little nauseous; This is a spontaneous report received. A contactable consumer (patient) reported 80-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unknown route of administration, administered on left arm on 10Mar2021 10:00 (at the age of 80 years old) (Batch/Lot Number: not reported) as 1st dose, single dose, for COVID-19 immunisation. Patient's medical history included benign prostatic hyperplasia (BPH) on an unspecified date and penicillin allergy. Concomitant medications were not reported. The patient has not had COVID before vaccination nor tested after vaccination. On 12Mar2021 06:00, the patient experienced vertigo type feelings. The patient felt woosey and a little nauseous. The patient did not receive treatment for the reported events. The outcome of the reported events were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Extreme tiredness, aching legs, pains across whole of chest, swollen left foot, shortness of breath , "pins and needles" in bothe hands at the same time as each other, loss of balance when walking, stomach pains only in the evening after eating a Small amount of food as I have put on weight recently even though I am eating the same amount ( less recently as above) as normal for the last 70 years.

81-year-old male with a history of stage IV renal disease, breast carcinoma status post mastectomy last year, hypertension, diabetes, hyperlipidemia presents to the ED via EMS complaining of general weakness and tiredness. Patient also had 2 episodes of vomiting prior to arrival to the ED (one time this morning, and one time on the EMS ride). He denies any abdominal pain, he denies any fever, he denies any chest pain, denies diarrhea or urinary symptoms. Of note, pt is 3 days post op from left upper extremity AV graft placement. Denies any pain or excessive bleeding at the site, but site is noted to be bruised appearing. He had lung infiltrates. He has been on doxycycline. He was also found to be positive for Covid 19. He was seen by multiple consultant including nephrologist, cardiologist, infectious disease specialist., Diabetes management, vascular surgery, Pulmonology. Due to his comorbidities, he was given bamlanivimab 700, etesevimab 1400 mg monoclonal antibody infusion on 4/29/2021.

ED to Hosp-Admission Discharged 6/18/2021 - 6/19/2021 (17 hours) Hospital MD Last attending ? Treatment team Musculoskeletal chest pain Principal problem Hospitalist Medicine History and Physical Date: 6/18/2021 Admission Date: 6/18/2021 PCP: MD DOB: 3/16/1940 Hospitalist: MD Assessment/Plan Medical Problems Hospital Problems POA * (Principal) Atrial fibrillation with RVR (CMS/HCC) Yes COVID toes Yes Angina of effort (CMS/HCC) Yes Atrial fibrillation (CMS/HCC) Yes Medical Problems Plan: 1. Will be admitted to icu because of angina like smptoms montor 2.repat tropon 3. Check bmp bnp and echo in am 3.check tsh mag 4.covid precautions5. Cardiology and ID consut in am if needed VTE prophylaxis: already on eliquis avoid nsaids because he is on eliquis will try tylenol if needed morphine for severe pain Full Code History of Present Illness Pt. is an 81yr male. Very pleasant male with history of choronic afi on eliquis history of hypertenson hyperchol Had ultrasound of the carotid arteris which showed stenosis Today he was mowing lawn developed left sided cheestpain pressure with no radiation to the neck arm s shoulder he was not diaphoretic. No fever chills or cough his covid is postive denies nausea vomiting or abdominal pain Came to the ER initially he was tachycardic with heart rate of 136 ekg showed right bundle with A-fib His initial troponin is negative less than 0.03 Has wbc cont of 11.8 hb 14.3 hct Normal platelets 188 na 142 k4.0 cl 110 c02 223 bun 17 cr 1.07 ast 15 alt 16 blood sugar of 148 Continue with chestpressure little anxious sats stable Considered his multiple risk factors and rapid a fib on arrival therefore he will be admitted in icu And montor his oxygen sats in case if it get rapid may need iv blocker or amiodarone Family history father died at the age of 63 from cAD /MI Mother died of old age at 93 Assessment Review of Systems Constitutional: Negative for activity change, appetite change, chills, diaphoresis, fatigue, fever and unexpected weight change. HENT: Positive for trouble swallowing. Negative for congestion, ear discharge, mouth sores, sinus pressure, sinus pain, sore throat and voice change. Eyes: Positive for visual disturbance. Negative for photophobia, pain and redness. Respiratory: Positive for chest tightness and shortness of breath. Negative for apnea, cough, choking and wheezing. Cardiovascular: Positive for chest pain and palpitations. Negative for leg swelling. Gastrointestinal: Negative for blood in stool, diarrhea, nausea and vomiting. Endocrine: Negative for cold intolerance, heat intolerance, polydipsia and polyphagia. Genitourinary: Negative for difficulty urinating, flank pain and hematuria. Musculoskeletal: Positive for arthralgias. Negative for back pain, gait problem, joint swelling, myalgias, neck pain and neck stiffness. Skin: Negative for color change, pallor and rash. Neurological: Positive for headaches. Negative for dizziness, tremors, seizures, syncope, facial asymmetry, speech difficulty, weakness and numbness. Psychiatric/Behavioral: Negative for agitation and behavioral problems. Past Medical, Social and Family History Medical History No past medical history on file. Surgical History No past surgical history on file. Social History Socioeconomic History ? Marital status: Married Spouse name: Not on file ? Number of children: Not on file ? Years of education: Not on file ? Highest education level: Not on file Occupational History ? Not on file Tobacco Use ? Smoking status: Not on file Substance and Sexual Activity ? Alcohol use: Not on file ? Drug use: Not on file ? Sexual activity: Not on file Other Topics Concern ? Not on file Social History Narrative ? Not on file Social Determinants of Health Financial Resource Strain: ? Difficulty of Paying Living Expenses: Food Insecurity: ? Worried About Running Out of Food in the Last Year: ? Ran Out of Food in the Last Year: Transportation Needs: ? Lack of Transportation (Medical): ? Lack of Transportation (Non-Medical): Physical Activity: ? Days of Exercise per Week: ? Minutes of Exercise per Session: Stress: ? Feeling of Stress : Social Connections: ? Frequency of Communication with Friends and Family: ? Frequency of Social Gatherings with Friends and Family: ? Attends Religious Services: ? Active Member of Clubs or Organizations: ? Attends Club or Organization Meetings: ? Marital Status: Intimate Partner Violence: ? Fear of Current or Ex-Partner: ? Emotionally Abused: ? Physically Abused: ? Sexually Abused: No family history on file. Allergies and Medications No Known Allergies Prior to Admission medications Medication Sig Start Date End Date Taking? Authorizing Provider apixaban (ELIQUIS) 5 mg tablet Take 5 mg by mouth 2 (two) times a day Yes Provider, Historical, MD atorvastatin (LIPITOR) 10 mg tablet Take 10 mg by mouth at bedtime 5/20/21 Yes Provider, Historical, MD clonazePAM (KlonoPIN) 0.5 mg tablet Take 0.5 mg by mouth at bedtime 6/14/21 Yes Provider, Historical, MD metoprolol succinate XL (TOPROL-XL) 25 mg 24 hr tablet Take 12.5 mg by mouth daily 6/2/21 Yes Provider, Historical, MD NIFEdipine XL (PROCARDIA XL) 30 mg 24 hr tablet Take 30 mg by mouth daily 6/12/21 Yes Provider, Historical, MD omeprazole (PriLOSEC) 40 mg capsule Take 40 mg by mouth daily 5/26/21 Yes Provider, Historical, MD tamsulosin (FLOMAX) 0.4 mg capsule Take 0.4 mg by mouth daily 4/26/21 Yes Provider, Historical, MD Objective Objective Current Min/Max Temperature: 36.1 °C (97 °F) Temp Min: 36.1 °C (97 °F) Max: 36.1 °C (97 °F) Heart Rate: 99 Pulse Min: 80 Max: 116 Resp: 18 Resp Min: 18 Max: 18 BP: (!) 148/89 BP Min: 121/103 Max: 148/89 SpO2: 96 % SpO2 Min: 94 % Max: 98 % No intake/output data recorded. Weight: Wt Readings from Last 1 Encounters: 06/18/21 75.8 kg (167 lb 1.7 oz) Physical Exam Physical Exam Vitals reviewed. Constitutional: Appearance: He is well-developed. He is not ill-appearing or diaphoretic. HENT: Head: Normocephalic and atraumatic. Eyes: Extraocular Movements: Extraocular movements intact. Pupils: Pupils are equal, round, and reactive to light. Neck: Vascular: No hepatojugular reflux or JVD. Trachea: No tracheal deviation. Cardiovascular: Rate and Rhythm: Rhythm irregular. Pulmonary: Effort: Pulmonary effort is normal. No accessory muscle usage. Breath sounds: Normal breath sounds. No stridor. Abdominal: General: Bowel sounds are normal. There is no abdominal bruit. Palpations: Abdomen is soft. There is no splenomegaly. Tenderness: There is no abdominal tenderness. There is no rebound. Musculoskeletal: Cervical back: Normal range of motion and neck supple. Lymphadenopathy: Cervical: No cervical adenopathy. Skin: General: Skin is warm. Capillary Refill: Capillary refill takes less than 2 seconds. Coloration: Skin is not cyanotic or pale. Findings: No rash. Nails: There is no clubbing. Neurological: General: No focal deficit present. Mental Status: He is alert. Cranial Nerves: No cranial nerve deficit. Motor: Weakness present. Psychiatric: Mood and Affect: Mood is anxious. Signed, MD Hospitalist Medicine 6/18/2021 10:08 PM

coughing; Pulmonary embolism/ respiratory impairment; Sinus infection; Was cold and so cold to the touch/ couldn't get warm; tired; Didn't feel good; just wanted to stay down and didn't want to get up/ just couldn't wake up; eat very little and he didn't like to eat; color was off, looked grey; Pressure in lower stomach; Lost weight; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient of unspecified age and gender received the first/second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via intramuscular at left arm on 02Feb2021 10:00 (80-year-old at time of vaccination), at single dose, for COVID-19 immunisation. The patient's medical history included Stents from 2005 (a stent placed in 2005; a heart attack in 2017 and additional 5 stents were placed in 2017; a stent placed in his neck in Nov2019); Heart attack from 2017; Reaction to contrast dye from 2005 (has a reaction to the dye that they use for stents; had a stent placed in 2005 and had a reaction to the dye then; a mild heart attack in 2017 and did stents; once again had a reaction to the contrast dye); Sensitivity to bug bites (When the patient got big bites, you would think someone had beat him he had so many knots; the last few years the patient's reaction to bug bites got much worse); High blood pressure. Additional information for other conditions: The patient was very highly allergic or has a reaction to the dye that they use for stents. The patient had some heart stents and he had bad reactions to the contrast used. The patient was allergic to different things. The patient couldn't take codeine. When the patient got big bites, you would think someone had beat him he had so many knots. Reaction to contrast dye: the patient's physicians then wanted to do imaging with contrast dye on the patient's neck. Physician put the patient on a cocktail for 24-48 hours before the stent was placed and the patient still had a reaction. The patient was given a cocktail of Benadryl and 2 other medications that she cannot remember. The patient's reaction to the dye was not as bad as the first 2 but he still had one. The patient had the stent placed in his neck in Nov2019. The patient still had a reaction to the contrast dye, a mild reaction, even with the cocktail. The reaction was enough the patient was told to continue taking the medication afterward. The patient always carried a nitro bottle in his pocked but he never took any of them. They asked how the nitro tablets were and they were powder. They were blessed as far as the patient's heart. Concomitant medications included cetirizine taken for allergy problems; amlodipine taken for high blood pressure for years; acetylsalicylic acid (ASPIRIN) (for the arteries, just to keep the blood thin, the patient began taking aspirin after experiencing side effects from Effient). The patient previously received codeine and experienced sensitivity (Couldn't take codeine, goes way back, 40-50 years). The patient previously received prasugrel hydrochloride (EFFIENT) from 2017 and experienced shortness of breath (The patient was put on Effient after his stent placement in 2017. Doctor took the patient off of Effient and instructed him to just take aspirin because the patient was showing side effects of shortness of breath and different things. Doctor informed the patient that he would rather the patient just take Aspirin than have the side effects from Effient). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 12Jan2021 (80-year-old at time of vaccination) for COVID-19 immunisation and experienced "so excited" (the patient was so excited after the first shot of the COVID-19 vaccine). The patient previously received tetanus vaccine toxoid (TETANUS) shot for immunisation (20 years ago at least) and experienced "Couldn't move arm, arm swelled and turned red and was messed up for a while". Prior vaccinations within 4 weeks was none. Patient's wife reported that she and her husband (the patient) took the COVID-19 vaccines on 12Jan2021 and 02Feb2021. After his second dose, the patient kept telling her that he didn't feel good and that he was tired (from 03Feb2021). The patient just did not feel good. The patient was cold and so cold to the touch (from 03Feb2021). On 03Feb2021, he was dragging. The patient just wanted to stay down and didn't want to get up. She asked the patient if this was going to keep him in the room all day. The patient replied that he just couldn't wake up. The patient was tired and cold and couldn't get warm. The patient lost 30 pounds (in Feb2021) after he got the second dose of the COVID-19 vaccine. The patient walked around holding his pants up. The patient would eat very little and he didn't like to eat. When he was weighed at the doctor on Friday 02Apr2021, he weighed 136 pounds fully clothed. The patient normally weighed 150-160 pounds. The patient had lost a lot of weight. The patient's color was off, stating that one of her friends said the patient looked grey. The patient experienced pressure in lower stomach (in Feb2021). The patient told her that in his lower stomach, he described it as pressure, and the patient thought he was just kind of sore from coughing from the sinus infection. The patient couldn't stand clothes to touch him and would cut holes in his underwear elastic so that it wouldn't press into him. The patient went to the doctor twice from the time he took the second shot of the COVID-19 vaccine to his death (on 04Apr2021). The patient went to the clinic. The clinic thought the patient had a sinus infection (from 27Mar2021) and gave him a shot that would make him feel good. The patient got a shot on 27Mar2021. She wasn't sure what the shot was and she didn't get a print out. They treated the sinus infection with amoxicillin-clavulanate (875mg-125mg, manufacturer is Teun). The amoxicillin hadn't worked well and the patient went back to the clinic a second time on Friday, 02Apr2021. When the patient went to the doctor on 02Apr2021, they were unable to get a register on the finger pulse-ox monitor. The patient's physician did an X-ray (on 02Apr2021) and the X-ray was perfectly fine (normal). Nothing showed up on the X-ray at all. The patient passed away easter Sunday morning (04Apr2021). The cause of death listed on the patient's death certificate is due to consequence or problem of pulmonary embolism (from 04Apr2021), respiratory impairment. The patient did not receive an autopsy. The family didn't feel the need and the staff didn't even ask if the family wanted an autopsy. "When you live to be 80 years old, you're blessed." HCP: The patient's heart doctor did not see the patient on 04Apr2021 before he died. The last time the patient saw the doctor was Dec2020. The wife reported that she is not complaining, the patient made the decision to take the shot, she is just concerned that the patient had something that could help someone else. The wife stated she was not trying to complain at all, she took the COVID-19 vaccine right beside him and had no consequences. She didn't even have a sore arm. The family is just concerned that there is an ingredient in the COVID-19 vaccine or something that could trigger that in them. Yesterday, 23Jun2021, they were showing a lady on TV that was so sick (unable to provide details). "The patient" (unknown to which patient this is referring) got the shot and ended up in the hospital with side effects. The wife reported that's why she wanted to let Pfizer know about her husband. She was just reporting the patient's symptoms and was not wanting to hurt anyone's feelings in the world. She is not blaming the COVID-19 vaccine for the patient's death, and stated that it could have been his heart or more anything. She just felt like she needed to let pfizer know some of the side effects the patient was having that didn't start until after the second COVID-19 shot. The wife unable to provide the NDC number, lot number, or expiry date of the patient's COVID-19 vaccines. She does not have the information but her son does have that if Pfizer wanted to call and talk to him. The adverse events did not require a visit to emergency room; the adverse events requiref a visit to physician office (The patient went to the clinic 27Mar2021 and went back 02Apr2021 for Sinus infection). Therapeutic measures were taken as a result of the event sinus infection and included a shot and amoxicillin-clavulanate. The outcome of the event pulmonary embolism/ respiratory impairment was fatal; outcome of other events was unknown. The patient died on 04Apr2021. No autopsy was done. The cause of death was pulmonary embolism/ respiratory impairment. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Pulmonary embolism/ respiratory impairment

No adverse event after the vaccination in March. Case went for his Dialysis (at a separated private setting for their covid patients) on 6/29/2021. Was supposed to have dialysis tx on 6/26 but that one got cancelled due to his sxs and subsequent test. After dialysis session on 6/29, case was disoriented (more than usual after tx), hard to direct/assist in transfer, decreased coordination at home, diarrhea. Family tried to care for him but by next day 6/30 (Wed) realized it was more serious, and via ambulance went to the hospital and admitted on 6/30/2021 through 7/7/2021. Was in ICU but not ventilated. DIscharged to an extended care facility on 7/8/2021.

Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 3/31/2021). Patient was admitted to the hospital on 7/5/21 for cough, poor appetite and dizziness for at least 3 weeks and tested positive SARS-CoV-2. On admission patient was febrile to 100.3, O2 SAT 95% on RA but desaturated to 89-90% with ambulation. He did not receive any COVID specific therapies and was discharged in stable condition on 7/7/21.

Sour tongue; sour taste in my mouth 24 hours a day; Diarrhea like symptoms; Tiredness; Occasional tingling in my fingertips; Mouth irritation; This is a spontaneous report form a contactable consumer. This 80-year-old male patient reported for himself stating that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6205) via an unspecified route of administration into the left arm on 11Mar2021 14:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Have a surgery but have seem to get a clean health, thinks that all was good. He has no other health problems really, nothing other the old age, no problems. Concomitant medication included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop dates were not reported, takes one of them every day. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9266) via an unspecified route of administration into the left arm on 18Feb2021 16:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. On 11Mar2021, the patient experienced mouth irritation. On an unspecified date, he experienced sour tongue; sour taste in his mouth 24 hours a day, diarrhoea like symptoms, tiredness and occasional tingling in his fingertips. The patient underwent lab tests which showed magnetic resonance imaging on 10Jun2021 and positron emission tomogram on 15Jun2021, both as negative, they could not find any cancer, correct. He spoke to several doctors since his changes of taste were occurring and had constant mouth irritation, sour tongue since, third week from his first COVID shot. Did not know how to describe it but it was a sour taste in his mouth 24 hours a day and it seems to he does not know what else to say about it expect talked to doctor several times and couples of other specialists that he has been seeing and they think it possible that it could be linked to the COVID shot since it was the sourness that he feels in his mouth was one of the symptoms of COVID. He had a couple of other side effects but few weeks ago they went away, for about a month from that day he was going to call loose bowels, not terrible but diarrhoea like symptoms and they lasted probably 3 weeks. Had tiredness that he experienced and was not experiencing now. Seemed to be quite good about that and occasional tingling in his fingertips but that seems to be helped, it was almost gone but once in a while. Those all sort occurred at same time but the sour taste in his mouth and tongue was constant or just do not go away. No other medical conditions. Treatment for event included that he went to doctor several times and he just suggested nothing to do about it.no prior vaccination. He was thrilled that he was able to get through there that day. Outcome was not resolved for event sour tongue; sour taste in my mouth 24 hours a day and was unknown for rest of the events.

patient began with vomiting and diarrhea the day after administration, leading to bowel and urine incontinence. patient was hospitalized on 01/16/20 with sepsis. no origin discovered yet. still waiting on blood/urine/stool cultures.

tired and fatigue, soreness in arm on first day, diarrhea,sore knee, magnified any type of pain he initially had:shoulder pain as well

4 days after receiving the shot I lost complete bladder control for 2 days. Two days after that I had diarrhea once a day for two days

hit was head and it was bleeding; hit was head and it was bleeding; dizzy; fell; Nauseous; This is a spontaneous report from a contactable consumer (Husband). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 18:00 on Arm left at single dose (Lot # EL3249) for covid-19 immunisation. Medical history and concomitant medications were none. He did fine right after, his arm wasn't sore, he felt fine. The next day he had nothing, no soreness, nothing, he felt great the next day. Dizziness started in the morning 17Jan2021 when he got up he said good morning and then said he would bring her back a cup coffee then he became very dizzy and leaned against the wall for support and then he fell, he was okay but he fell. He did go the emergency room because he fell and hit was head and it was bleeding. They told him it was not related to the vaccine but it is one of the things that are on the form that could happen. She says it was okay if it caused it she is just looking for a reason. Now today (18Jan2021) he feels fine she wants to know what causes that side effect. She says she is supposed to be getting her vaccine too. He had one bad dizzy spell and then it went away, and she thinks he got kind of nauseous with it. It says this can happen, it said it could happen right after but in his case it did not, it happened within probably 34 hours or something. Outcome of the event dizziness has recovered completely at this point. Outcome of other events was unknown.

On 2/4/21, at around 3:00pm he began feeling very tired and he began burping in the evening. The following morning, he woke up early and was still burping and not feeling well. At around 5:00am, he collapsed. My mother called 9-1-1 and began giving CPR. The parademics arrived and tried to revive him, and transported him to the hospital but at 6:11am, he was pronounced dead of a heart attack. He was healthy.

nauseous; He's having some episodes of going on in his head almost like a headache, hard to explain what's going on; He's having some episodes of going on in his head almost like a headache, hard to explain what's going on; This is a spontaneous report from a contactable consumers (patient's wife and patient). An 81 year old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263), via an unspecified route of administration on 23Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included bleeding ulcer and stent put in my heart valve. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) and acetylsalicylic acid, clopidogrel bisulfate (CLOPID-AS [ACETYLSALICYLIC ACID;CLOPIDOGREL BISULFATE]). On an unspecifed date, the patient's wife reported that her husband: He's having some episodes of going on in his head almost like a headache, hard to explain what's going on. Also nauseous, with the heart specialist told him to take probiotics with his medicine. He was hospitalized on January 7-11. He is on 81mg low dose aspirin, Clopidogrel 75mg daily medication. Prior to that week before Nov2007 he had a reaction to the aspirin and was hospitalized because it gave him a bleeding ulcer. The patient was hospitalized for the events on an unspecified date. Outcome of the events was unknown.

The patient developed sudden onset nausea, diaphoresis and hypotension and shaking. Symptoms improved with IV fluids and rest. She was hospitalized 2 days.

Severe nausea and vomiting General body aches, but more severe lung/chest area pain, but with NO shortness of breath Overall fatigue

Patient has history of COVID19 infection on November 2020. He received first dose of pfizer COVID 19 vaccine on 2/2/21. Six days later on 2/8/21, the patient presented to the ED with complaints of cough, dyspnea, and vomiting. Patient was breathing on room-air, blood pressure was stable, and he wasn't febrile. Patient was admitted for bilateral pneumonia. Initial COVID test on 2/9/21 was negative and patient received 7 days of antibiotic therapy. Throughout the patient's stay, his respiratory function was stable on room air. Patient was to be discharged at the end of the antibiotic therapy but a follow-up COVID PCR test on 2/17 resulted POSITIVE. Patient's s/s for infection were already improving and the providers held off on discharging to be sure the patient was asymptomatic for COVID 19. Patient was uneventfully discharged on 2/26/21 for a total stay of 18 days.

Developed watery diarrhea; malaise; weight loss; collagenous colitis on colonoscopy biopsies; This is a spontaneous report from a contactable physician (patient). An 81-years-old male patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included was none. No covid prior vaccination. No known allergies. Concomitant medication included allopurinol (ALLOPURINOL), losartan potassium (COZAAR), tadalafil (TADALAFIL), acetylsalicylic acid (ASPRIN), simvastatin (ZOCOR). Historical vaccine included BNT162B2 details: (Product= COVID 19) for covid-19 immunisation, Lot number= EL1284, Administration date= 31Dec2020, administration time= 11:00 AM, vaccine location: Left arm, dose number= 1, Developed watery diarrhea about 5 days after the dose. No other vaccine in four weeks. Adverse event: watery diarrhea improved somewhat but worsened again after the second dose of vaccine, along with some malaise and weight loss, since 05Jan2021. Extensive investigations eventually revealed collagenous colitis on colonoscopy biopsies in Jan2021. May well be coincidence, but interested to know if others have been reported. AE resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Anti-diarrheals, budesonide. The event outcome of collagenous colitis was recovering, watery diarrhea was not recovered, outcome of other event was unknown. Covid test post vaccination covid test date=19Jan2021, which was negative.; Sender's Comments: Based on the available information, the company considers that a causal relationship between collagenous colitis on colonoscopy biopsies and bnt162b2 cannot be excluded due to plausible temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021229604 same patient/reporter, different AE/first dose

81 y.o. male with a past medical history of anemia, DVT, gout, hyperlipidemia, hypertension, presents to the ER with change in mental status. Patient was otherwise in his usually state of health. He got his 2nd COVID-19 vaccine on 3/5. His wife noticed on Sunday, he started acting strangely, more confused. He was given his remote, and forgotten how to use it. He came to the hospital; has progressively gotten weaker, unable to walk, swallow, severe dysphagia, pupil unreactive, patient staring at ceiling. CT head; normal; CXR is normal. Platelets: 91,000.

Day 1-Confusion and weakness Day2-Increase in weakness, inability to swallow, confusion, fatigue Day 3-Weakness, confusion, incontinence, hospitalized for hypoxia, pneumonia Day 20- Deceased

Patient developed a syncopal episode one day following the vaccine. Without warning, he fell to the ground, losing control of bowel and bladder, although no seizure activity noted at the time. He transiently lost consciousness and then woke up confused and combative. Brought to emergency room and admitted with multiple rib fractures. Initial brain imaging was negative but 24 hours later, noted to have small hemorrhagic brain contusion in left frontal/temporal region and a small subdural hematoma. One day later, there was not noted to be any extension of the hemorrhage/hematoma.

Developed watery diarrhea; This is a spontaneous report from a contactable physician, the patient. An 81-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EL1284), via an unspecified route of administration in the left arm on 31Dec2020 (at the age of 81-years-old) as a single dose for COVID-19 immunization. Medical history was none. The patient had no known allergies. Concomitant medications included allopurinol (ALLOPURINOL), losartan potassium (COZAAR), tadalafil (TADALAFIL), acetylsalicylic acid (ASPRIN) and simvastatin (ZOCOR); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19 on 19Jan2021 and result was negative. The patient developed watery diarrhea about 5 days after the administration of vaccine on 05Jan2021. Therapeutic measures were taken as a result of developed watery diarrhea with anti-diarrheals, budesinide. The event, diarrhea was resulted in doctor or other healthcare professional office/clinic visit. The outcome of event, diarrhea was recovering as it was improved somewhat.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021185835 second dose

About 2 weeks after his first covid vaccine, he developed stomach pain, bloating, diarrhea and fatigue. Normally a very active, energetic patient with no history of GI disease. Developed anemia of chronic disease which was confirmed by hematology consult. On 2/18/2021 he had a colonoscopy which revealed Microscopic Colitis (collagenous colitis) proven by biopsy. Started on oral Entocort with the improvement of his symptoms and anemia

difficulty breathing; He hasn't been able to walk the last couple of days and has had to use his wheelchair; she has been taking his temperature; no energy; can't walk; very thirsty; extremities he complains are cold even though they are not and he is feeling pain in them; dry heaves; pain and bloating in his stomach; pain and bloating in his stomach; his extremities felt cold; shivering; night sweats; wasn't eating or drinking/Has not been able to eat; This is a follow-up spontaneous report from a Pfizer-sponsored program. This is a spontaneous report from a contactable consumer. A 81-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), Lot number was not reported), via an unspecified route of administration on 02Feb2021 (at the age of 81-year-old) as single dose for COVID-19 immunization.Medical history included Transverse Myelitis which is a virus of the spinal cord (from age of 11 yr), wheelchair user, difficulty walking (from the transverse myelitis). Reporter and her husband both received the first Pfizer Covid vaccine on 02Feb2021.The patient's concomitant medications were not reported. On11Feb2021, patient experienced dry heaves, pain and bloating in his stomach, his extremities felt cold and he was shivering, had night sweats and wasn't eating or drinking. He has been feeling progressively worse since Feb 11th, but she stated she has been taking his temperature and he did not had a fever but had been very thirsty. He had not been able to walk the last couple of days and had to use his wheelchair. Last night on 10Feb2021, he probably drank gallons of water due to his excessive thirst. His doctor told him to take acetaminophen and ibuprofen, which he did, but it didn't help. His symptoms have progressed such that the reporter dropped her husband off at the ER today. Reporter stated that he now did have a fever and is awaiting results of a chest x-ray and lab work (performed on 16Feb2021). He was having difficulty breathing, but his oxygen levels were normal. Reporter read online about two people in (city) developed transverse myelitis after receiving a Covid vaccine, but she was not sure which vaccine they received. She was calling to report this information to Pfizer and to see if these types of reactions have been reported and at 10 days post initial vaccination. The patient Is currently in the emergency Room and has not been able to eat for 5 days. The outcome of events was unknown. Information on the lot/batch number has been requested.

difficulty swallowing; difficulty breathing; a little swelling in the throat; This is a spontaneous report from a contactable consumer (patient). An 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 16:30 as SINGLE DOSE in Arm Right for covid-19 immunisation. Medical history included He has seasonal allergies and sneezes. He does not take medication for it. It has been diagnosed 3-4 years ago. It is not real bad. Concomitant medications included atenolol taken 10-15 years, amlodipine taken for 10 years, both for high blood pressure. Prior Vaccinations (within 4 weeks) was none. AE following prior vaccinations was None. Vaccination facility type was Clinic. After 5-6 hours after the first injection he developed difficulty swallowing, a little difficulty breathing and a little swelling in the throat on 11Mar2021. When he took first shot, there was no reaction until 5-6 hours later. He had trouble swallowing at 21:30-22:00. He was concerned about these side effects and whether he should receive the second shot. NO ER or physician's office required. The outcome of a little swelling in the throat was recovering, of other events were unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

This 81 year old white male received the Covid shot on 3/11/21 and went to the ED on 4/2 and was admitted on 4/4 with shortness of breath, pericardial effusion, pulmonary edema, CHF and again to the ED on 4/30 and admitted on 4/30 with abdominal pain, hypoatremia, renal insufficiency and again to the ED on 5/1 with pericardial effusion and died on 5/4/21.

Increased confusion/dizziness today. Increased weakness. Withdrawn affect. Incontinent of urine/stool.

muscle pain in my chest and going down my rib cage; feet felt like ice; Calf muscle also hurt; could not find a comfortable way to sit or lie down; muscles still tingle a little bit; lost my appetite; tired; This is a spontaneous report from a contactable consumer or other non hcp. A 81-year-old male patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EL9262 and Expiration date was not provided), via an unspecified route of administration, administered in Arm Right on 02Feb2021 15:30 ((age at vaccination 81-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included myelitis transverse. I had Transverse Myelitis 70 Years ago at age 12. No other allergies were reported. No covid was reported prior to vaccination. The patient's concomitant medications were not reported. No other vaccination in four weeks and no other medications in two weeks. On 11Feb2021 20:30, the patient experienced muscle pain in my chest and going down my rib cage, feet felt like ice, calf muscle also hurt, could not find a comfortable way to sit or lie down, muscles still tingle a little bit, lost my appetite, tired. The patient underwent lab tests and procedures which included sars-cov-1 test: unknown on 14Feb2021. Therapeutic measures were taken as a result of muscle pain in my chest and going down my rib cage, feet felt like ice, calf muscle also hurt, could not find a comfortable way to sit or lie down, muscles still tingle a little bit, lost my appetite, tired. The outcome of event was Not recovered/Not resolved.

Symptoms of Myasthenia Gravis starting 5 days after vaccine including : -Double Vision treated by corrective lenses -Chronic muscular weakness in legs, back, arms and neck treatment on going with prednisone and pyridostigmine. Throat and jaw weakness affecting swallowing and chewing

Patient brought to ED due to what he described as indigestion not improving over time. Diagnosed with ST elevation MI on EKG. 4 stents were placed in the RCA, EF at 50%. Given Brilenta and admitted to ICU. Discharged and placed on atorvastatin and ticagrelor.

Systemic: Exhaustion / Lethargy-Severe, Systemic: "arm tested positive to be magnetic"-Severe, Systemic: Vomiting-Severe, Additional Details: patients family called to report that the patient had experienced side effects with the 2nd dose. they took the patient to the hospital because he was tired and vomiting. they ran tests and a test showed that his arm was magnetic where the vaccine was given

PT ADMITTED TO HOSPITAL FOR COVID PNEUMONIA ON 6/17/21. RECIEVED PFIZER VACCINES ON 1/29/21 AND 2/24/21 (UNSURE WHERE THESE WERE RECEIVED). 1.5 WEEK HISTORY OF DECLINE IN FUNCTION INCREASED CONFUSION, CHRONIC PAINS, DECREASED ENERGY, SUBJECTIVE CHILLS, CONGESTION AND DECREASED APPETITE. SAT 89% ON RA UPON ARRIVAL. PUT ON 8L/NASAL CANNULA. REMOTE HX OF LYMPHOMA S/P RADIATION AND CHEMO 3 YEARS AGO. WILL GET REMDESIVIR AND DEXAMETHASONE HERE

81 yo male patient with a history of leukemia, diabetes, renal failure, htn, hyperlipidemia, and nephrolithiasis presents with increasing weakness over the last several days. The patient states that he received his second pfizer covid vaccination on Monday. Since then has felt weak and tired. Has been short of breath with any exertion. No fever or chills. No chest pain. Has had a cough when he breathes through his mouth. He states he is only short of breath when he breathes through his mouth. No nausea or vomiting. Had one episode of diarrhea. No blood in the stool or black stool. No abdominal pain. No urinary symptoms. Has been eating. Has been exposed to a known covid positive contact at home between

Same as I had when I had Covid-19 seven months previously: extreme fatigue and total loss of appetite, but this time it lasted only 13 hours instead of 10 days or more. I tested positive for Covid-19 antibodies 2 weeks prior to the shot.

All events took place: Following first dose, minor rash on left arm; following second dose, first developed severe rash on arm and belly, extreme fatigue, severe hiccups and inability to swallow without choking; ultimately developed liver and kidney failure, was diagnosed with DRESS syndrome resulting from reaction to vaccine, was administered high-dose corticosteroids and antibiotics but continued to decline, developed hemorrhage in lungs and died due to multi-organ failure. PDF Continuation field did not permit entering text, see attached Continuation Page.

Patient not feeling well, decrease in oral intake, general weakness, abdominal pain, nausia. Diagnose with moderate to high grade small bowel obstruction. Patient was given IV fluid, Zofran, Steroids and pain meds. Patient still in hospital

Sever abdominal pain extending up center of chest to ears and down center of back. Sever pain if trying to lay flat. Initial occurrence March 31,2021 approximately two weeks after 2nd Pfizer vaccination, Released from hospital same day but unable to lay flat for four days. Same symptoms reoccurred on May 26, 2021 and was admitted to the hospital for three days and it was determined my condition was pericarditis.

Patient is a 82 y.o. male presenting with shortness of breath and nausea and vomiting. Patient has a past medical history of bladder cancer, COPD on no home oxygen, hypertension, chronic UTI, BPH, and Pfizer vaccination from COVID-19 on 1/4/21 and 2/5/21. Patient was symptomatic with shortness of breath and nausea and vomiting since 07/13/2021. Patient went to urgent care and tested positive for COVID-19 on 07/19/2021. Patient went to the ER and received a fluid bolus as well as Zofran; the wife states that the Zofran does not help with the nausea and vomiting. At home, patient denies fever, muscle aches, chills, chest pain, abdominal pain. Patient admits chronic cough, chronic headache, and pain with urination, most likely due to BPH. Patient denies known history of sick contacts. COVID-19 pneumonia, tested positive 7/19/21, currently requiring 1-2 L of oxygen, baseline room air

burning when he urinates; sharp pain where his navel is; pain in his stomach; This is a spontaneous report from a contactable consumer reporting for himself. An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL1283), via an unspecified route of administration on 14Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included Parkinson's disease from an unknown date. The doctor told him to make an appointment with his Parkinson's doctor and tell him, maybe that has something do with it. There were no concomitant medications. The patient experienced burning when he urinates for 2 weeks, a sharp pain where his navel is, and pain in his stomach on Jan2021. He was wondering if it could be from the shot or if it is something else. He had an appointment with his doctor on Monday and he told him about it. The doctor gave him an antibiotic, Ciprofloxacin 500 mg that made him dizzy, he does not know if he will continue to take it but it helped the burning, the burning was not as bad. It was in a brown clear pharmacy bottle. The burning when he urinated is going away but the pain in his stomach comes and goes and it is right on his navel, it was described as a real hard pain. Patient would come back 03Feb2021 per vaccination card. Outcome of the event burning when he urinates was recovering while unknown for a sharp pain where his navel is, and pain in his stomach. The events were considered non-serious.

Complete body ache, nauseous, sweating, fever.......I felt like someone beat me up with a baseball bat....couldn't even get out of bed it started about 12:30 AM and lasted about the rest of the following day...

Discussed with ER provider last night about this patient. The abdominal findings and mild elevation of WBC gave us a hope to manage it with antibiotics alone because of his age, COPD, AAA. He was admitted to be kept NPO, and IV Zosyn was started. The understanding was to reassess the patient this morning and make appropriate decision Surgeon's H&P 1/10/21, Admitted from ER: Admitted with sudden onset of right lower abdominal pain started yesterday morning. Not associated with vomitings, diarrhea, fever Was seen in ER last night WBC 13K and CT scan showed appendicitis with multiple appendicoliths. This morning he is having pain, slightly worse. Not hungry WBC 11.3K. Afebrile

Pt with no previous history of abdominal aortic aneurysm presented to ER on 02.20.2021 with abdominal pain, weakness and BP of 50/30 via EMS. Abdominal pain started on 02.19.2021 approx 10:00 PM. Pain was described as severe in the left flank, radiating into the lower abdomen and worsened through the night. EMS was called around 11 AM. Pt CT Abd/Pelvis angiography shown Ruptured abdominal aortic aneurysm measuring up to 7.9 cm in diameter and 9.8 cm in length with active extravasation of IV contrast. Large volume of predominantly retroperitoneal hemorrhage. Pt was flown hospital for surgical intervention after being given 2 units of O neg blood with 2 L normal saline.

Patient developed persistent fevers and weakness and loss of appetite that continued for about 3 weeks after getting the vaccine. There was a delay of about a day from getting the vaccine that he developed symptoms. He came to the hospital at today, 2/23/2021 because of the persistence of his symptoms. Vitals were stable and within normal range, but he had elevated creatinine to 1.66, unknown baseline. Troponin was also elevated to 0.08 without symptoms of ischemic heart disease. EKG was normal.

1-21-21. Got first COIVID-19 vaccination at 7:15 AM (Phizer). No reaction whatsoever. Pfizer Lot:EL3249 2-11-21. Got second vaccination at 7:05 AM. Felt normal all day. Pfizer Lot:EL9264 2-12-21. Felt good early. Played tennis and worked out. About 2 PM, started feeling very poorly. Took 90 minute nap. Woke up nauseous and dizzy. Threw up several times. Could not drink or eat dinner. 2-13-21, Continued to feel badly. Threw up after arising. Couild not drink or eat breakfast. About 1:30 PM, was able to keep yogurt and cottage cheese down. Nibbled off and on. Ate light supper. 2-14-21. Woke up dizzy. Was able to eat normally. Still felt badly. Had bad headache (very unusual for me) before supper. Ate normal supper. Canceled tennis for following week. 2-15-21. Started feeling much better than day before. 2-16-21. Felt much better than the day before. 2-17-21. Best day since 2-11 ? the last 5 days. 2-18-21. Began to feel rocky. Slightly dizzy. Low energy 2-19-21. Felt worse than the day before. Low energy, short dizzy spells, little appetite. 2-20-21. Felt really bad. Very dizzy all day. Drippy nose for 5 hours, but nose okay by bedtime. Very tired all day. 2-21-21. Felt a little better. Still dizzy when I got up. Recovered enough to go to church at 10 AM. Note that it had been 10 days (at 7:05 AM) since I had my second shot. 2-22-21. Got up to the bathroom at 2 AM. Was dizzy. Got back to sleep until 6:30 AM. Was and am better than the last 4-5 days. Still feel a little shaky if I move quickly or get up out of my chair quickly. Very tired all day. 2-23-21, Doing better. Still wobbly on my feet. Only mildly dizzy. 2-24-21. Best day since 2-17. Still a little weak. Worked out in the late AM. 2-25-21. Felt a little dizzy in the AM. Better after lunch. Did light workout. Good day overall. Felt fine. 2-26-21. Felt good in the AM. Worked out. Feeling stronger than yesterday even. 2-27-21. Felt good 2-28-21. Felt tired all day 3-1-21. Did not sleep well. Worked out in the AM and then was very tired. Felt a little dizzy after returning home from the gym. Took short nap before lunch and am doing better in the PM.

Diarrhea; his arm was a little sore; This is a spontaneous report from a contactable consumer (patient's wife). An 82-year-old male patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER BIONTECH COVID-19 VACCINE; lot number: EL3247; expiration date: unknown) at the vaccination age of 82-year-old intramuscularly in the left arm on 25Jan2021 14:00 at a single dose for COVID-19 vaccination (COVID-19 immunization). The patient's medical history and concomitant medications were none. The patient did not received other vaccine within 4 weeks prior to vaccination. The wife reported that her husband got the first dose of the Covid-19 Vaccine on 25Jan2021 about 14:00 and did not have any reaction except his arm was a little sore on 25Jan2021 18:00. It is sore if he rubs the area, but has gotten better She said that last night, he developed diarrhea at about 22:30 26Jan2021. She inquired if this is a coincidence, he got the diarrhea or is it a side effect from the shot. She added that the diarrhea started about 36 hours after he got the first dose. He had the diarrhea at 22:30 26Jan2021, he had it again at 02:00 27Jan2021, and again at 07:00 27Jan2021 and he has not had it since. She said that her husband was saying he thinks it was getting better. She mentioned that after he received the vaccine, they waited for 15 minutes to make sure there was no reaction. She added that the vaccination facility type was health department drive through vaccination. The adverse events did not require emergency room or physician office visit. The outcome of the event was recovering.

Presented to the emergency department on 2/28/21 with exertional shortness of breath and upper abdominal discomfort for the past 2 days. Patient was admitted to the hospital, and pulmonary edema was contributed to right-sided heart failure from his mild COPD and suspected underlying interstitial lung disease. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine. This hospitalization does not appear to be related to the vaccine.

Patient received first dose of Pfizer/BionTech vaccine ~2:40p Patient experiencing palpitations and dizziness. patient took 1 nitro tablet, 3 minutes later patient told staff he was having chest pain and and nausea. He stated nitro was helping but he knew this was gonna be a bad one and 911 was called . 2 minutes later(2:56p) took 1 nitro tablet. still having chest pain, dizziness nausea. took third nitro tablet at 3:01p. BP 125/101 and 86 BPM. 5 minutes later BP was 138/78 mmHg. A and O x 3. ambulance transported him to hospital for further evaluation

Patient presented to the ER on 3/2 for urinary frequency and lower abdominal pain. He was hospitalized at Medical Center- on 3/2/2021 for small bowel obstruction and acute kidney injury. Patient passed on 3/2/2021.

Nausea. Lasted about 4 hours and I took care of it with two cups of tea. Minor problem; minor inconvenience.

Patient received his first dose of Pfizer COVID-19 vaccine on 02/03/2021. He has significant medical history, but presented to the hospital on afternoon of 02/08/2021 with report of three days of nausea and vomiting. He thought this attributed to a new cholesterol medication. He also reported some shortness of breath, mild cough, no fever. reported some epigastrium pain the day prior but since resolved. Significant other reported some significant swelling and that pt complained of feeling like he had a "blockage in his throat". Workup showed concerns of pneumonia so pt was started on antibiotics and Vitamin K. Shortly after meds started pt started complaining of itching arm and trouble breathing. He became bradycardic and lost consciousness. Resuscitative efforts initiated but unsuccessful. Time of death called on 02/08/2021 at 1737. Hospital notes report "cause of death is anaphylaxis", and pt would be an OME case.

Narrative: hospitalized for GI bleed subsequent to vaccination. Very low probability that vaccine was cause.

Constipation; This is a spontaneous report from a contactable consumer. A 82-year-old male patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: EN6201) via unspecified route of administration on Left arm on 11Feb2021 11:00 at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported on 11Feb2021 patient experienced constipation and did not received any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was "Recovered".

Patient began having abdominal pain in lower right quadrant 5 minutes after receiving vaccine. pain scale 6, constant, and lasted for 40 minutes while patient was in the store. Patient walked around but standing and walking did not relieve the pain. Patient's primary care doctor office was contacted and patient was directed that if the pain continues for 1 hour total, if patient could not stand up straight or urinated blood or symptoms worsened to go directly to ER. Patient left store shortly thereafter.

felt very tired/feeling exhausted/tiredness; Headache; muscle and joint pains; muscle and joint pains; Hot Flashes; Chills/cold chills; nauseous; he felt so hot; thought he had a fever; cramping all through the night to the point he wanted to cry; Couldn't Sleep; He specified the pain was in his hands, legs, feet/sore arm; weakness to the point he couldn't get up to go to the bathroom.; Feeling unwell; Dizzy; but everything else was sore too; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 82-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was reported as "EUO150"/"LU0150"), via an unspecified route of administration, administered in arm left on 13Apr2021 11:15 (at the age of 82-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included blood pressure, allergy, glucose-6-phosphate dehydrogenase deficiency (G6PD), liver genetic deficiency, and had allergy mice, cat, dust and trees. The patient previously took sulphur and aspirin and makes him bleed because his blood was already thin. Concomitant medications included amlodipine taken for blood pressure; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergy; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]) taken for an unspecified indication; all were start and stop date were not reported. An 82-year-old caller received the first dose of the Pfizer-BioNTech COVID-19 vaccine yesterday (13Apr2021), around 11:15 am. He added he was monitored for 15 minutes post injection and then used the public transportation to run some errands and return home. He said he received the injection on his left arm had soreness in this arm after vaccination. He explained around 3-3:30 pm he was walking to get the bus and then felt very tired to the point he wanted to sit on the pavement. He also described it as feeling exhausted. He explained he was so tired on the bus that he was falling asleep and almost missed his stop. He said he also began having joint and muscle pain on the bus. He specified he got home around 4 pm and he then experienced tiredness, headaches, muscle and joint pains, hot flashes, chills, and felt nauseous but didn't vomit. He specified he felt so hot, he had to turn off the heat and remove his clothes, but then he had chills/cold chills and had to turn the heat back on and thought he had a fever. He said around 11 o'clock he had appetite. He added he had cramping all through the night to the point he wanted to cry. He couldn't sleep. He specified the pain was in his hands, legs, feet, and joints. He also said he felt tired like he had worked for 12,000 hours and was not able to move. He said he had weakness to the point he couldn't get up to go to the bathroom. He said he had the headaches all through the night. He was feeling unwell, dizzy. He explained he felt like he was going to die; he was worried about his body. He said he still feels tired. They told him he would only have a sore arm, which he did, but everything else was sore too until about 08:00 today (14Apr2021). He explained that he didn't have all these issues before vaccination. He explained how disappointed he was with his reaction to the vaccine given that he was reluctant to the unapproved vaccine at beginning because he wasn't the person that take a lot of injection and medications, and so finally after his primary physician to influence him to get the vaccine. He mentioned he lives alone, healthy, vegetarian, never smoked, never took recreational drugs, does acupuncture, and takes little medications. He explained most people and his acupuncture doctor said he shouldn't get much reaction from the first dose and the reactions to the second dose are more prevalent. He added he was told that people have mainly experienced soreness in their arm after this vaccination with the first dose. He asked if his symptoms were reported after getting the first dose of the Pfizer-BioNTech COVID-19 vaccine. Everyone told him the first vaccine is a whiz. That it was easy. The second vaccine is the one that have side effects on. He also stated that he almost called to get an ambulance to take him to the hospital. Said that if he had these reactions with the first one, he does not want to take the second vaccine. Sometimes he regret that he have taken it now because he did not expect all of this to happen to him and they just told him that he will have a sore arm on left arm. He was in kind of shock to experience all of this and he was G6PD (Intent: History). He cannot take Sulfur and Aspirin because that makes him bleed because his blood was already thin but that would be no problem also have a liver genetic deficiency (Intent: History). He was allergic to mice, cat, dust and trees (Intent: History). So, he told all what he had that they knew in the beginning they said none of those things will affect. He take B12 (Intent: History) too once a month, he get injection for allergies for his cats and trees and grass once a month but they told him none of the things will affect him. The outcome of the events was unknown. Information about the lot/batch number has been requested.

COUGH ED to Hosp-Admission Discharged 3/5/2021 - 3/7/2021 (2 days) Hospital DO Last attending ? Treatment team Rectal bleeding Principal problem Discharge Summary DO (Physician) ? ? Internal Medicine HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Date: 3/7/2021 Admission Date: 3/5/2021 Length of stay: 0 Days PCP: MD Discharging provider: DO Discharge diagnosis: Hospital Problems POA * (Principal) Rectal bleeding Yes Glaucoma Yes COVID-19 virus infection Yes Overview Signed 3/5/2021 11:11 PM by MD Asymptomatic Disposition: Home CODE STATUS (LOI): Full Code Consulted Services: none Hospital Course HPI: Rectal bleeding Hospital Course: Patient was hospitalized bright red blood per rectum without evidence of acute blood loss anemia. He has a history of radiation colitis with lastest unrevealing colonoscopy in December 2011. He feelss improved with stable hemoglobin and did have normal bowel movement by next day. Likely this is internal hemorrhoids, probably isolated; no intervention warranted. Incidentally, patient had COVID positive but exhibits no symptoms. No CXR obtained; he will have second vaccination shot in 2 days as per previous scheduled. Disposition plan was discussed with patient's daughter over the phone on March 6. Hemoglobin was 12.6 upon discharge on March 7 when patient was deemed stable to transition out of hospital. _

pt received pfizer #2 on 2/20. on ~3/7 family noticed that he was waking up at night more than his usual. They noticed that the patient was more lethargic and was starting to have visual hallucinations. Reportedly, the patient never endorsed any fevers or chills, neither did he complain of headaches. He also reported that the patient had been having a nonproductive cough since 3/3, constipation around this time. he was admitted 3/10 with altered mental status, respiratory failure s/p intubation. difficult LP, no cell count, had elevated protein. hospital course complicated by delirium, gout flare. he was empirically treated with broad spectrum abx bacterial and viral meningitis, completed 5/6, without significant improvement in mental status. repeat LP concerning for possible autoimmune encephalitis, started on steroids.

pain; low energy; mild headache; mild nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 82-year-old male patient received bnt162b2 (BNT162B2, Solution for injection, Lot Number: E99261), dose 1 via an unspecified route of administration, administered in Arm Left on 02Feb2021 (at the age 82-year-old) as SINGLE DOSE for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced mild headache and mild nausea on 02Feb2021, low energy on 03Feb2021, pain on an unspecified date. Reporter stated that "He is calling about the covid 19 vaccine. He had his first shot yesterday afternoon at 2. He slept great. He had a mild headache last night and mild nausea. This morning he got breakfast, and it wasn't excruciation but still felt pain, as well as the nausea, and his energy level was not normal. As far as the headache, would it be okay to take Tylenol, and for the nausea can he take Phenergan or Dramamine, its not extreme but just uncomfortable. His First Dose of the Covid Vaccine was on 02Feb2021 at 2PM or 2:05PM. The mild headache started last night the same day. The Nausea started last night was mild, on the same day also. The energy level being low started today 03Feb2021". Caller confirms that "after the onset of events he took 2 tylenol last night at 7. He had a little sinus problem and took 1 of coricidin hbp sinus over the counter medication last night. Taking both together made him anxious. Thats why he is calling to find out in the morning. He does not want to take things close together". Outcome of the event pain was unknown and other were not recovered. Follow-up attempts are completed. No further information is expected.

Stomach pain (burning) a day after the second shot, lasting 4 days so far.; This is a spontaneous report from a contactable consumer reported for himself. A 82-years-old male 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 in Arm Left on 25Feb2021 11:15 as SINGLE DOSE for covid-19 immunization. Medical history and concomitant medication were not reported. Patient had allergies of Keflex. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection Batch/Lot number: unknown) via an unspecified route of administration in Arm Left on 04Feb2021 15:15 as SINGLE DOSE 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 tested for COVID-19 since the vaccination. On 27Feb2021 at 20:00 patient experienced stomach pain (burning) a day after the second shot, lasting 4 days so far. Patient didn't received treatment for the event. Outcome of the event stomach pain was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Whole body was in pain including my neck it felt like someone beat me up with a baseball bat; Whole body was in pain including my neck it felt like someone beat me up with a baseball bat; very nauseous; This is a spontaneous report from a contactable consumer (patient). A 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL1284, Expiration date: Not reported), via an unspecified route of administration, administered in arm left on 04Feb2021 09:15 as 2ND DOSE, SINGLE (age at vaccination 82-years) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient historical vaccine received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265, Expiration date: Not reported), via an unspecified route of administration, administered in arm left on 14Jan2021 15:30 as 1ST dose, single for COVID-19 immunization. The patient was not had COVID prior vaccination, and the test was not performed post vaccination. The patient did not receive any other vaccine within four weeks. The patient did not receive any other medication within two weeks. On 05Feb2021 12:30, the patient experienced that whole body was in pain including my neck it felt like someone beat me up with a baseball bat. I could not even get out of bed in the morning I also became very nauseous and thought I was going to throw up what can I do to get over these side effects. The treatment was not received for the event. The outcome of the events was reported as recovering. Follow-up attempts completed. No further information expected.

Diarrhea; Joint pain; Chills; This is a spontaneous report received from a contactable consumer. A 82-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 28Feb2021 at 13:00 (at the age of 82-year-old) as a single dose for COVID-19 immunisation. The patient had medical history included diabetes, high blood pressure and stroke. It was not sure if the patient had allergies to medications, food, or other products. It was not sure whether any concomitant medications was taken by the patient. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date of Feb2021 (at the age of 82-year-old) at 13:30 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 01Mar2021, at 02:00, the patient experienced joint pain and chills. On 03Mar2021, two days later patient developed diarrhea. The patient did not receive any treatment for 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 of joint pain, chills and diarrhea was recovered on an unknown date at the time of this report. Information about lot number cannot be obtained. No further information is expected.

Injection site pain; Injection site pain and swelling; Fatigue; Chills; Fever; Muscle and joint pain; Muscle and joint pain; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old male patient 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 05Mar2021 at 14:00 (at the age of 82-years old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 10Mar2021 at 18:00, patient experienced injection site pain and swelling, fatigue, chills, fever, muscle and joint pain, loss of appetite. The patient underwent lab tests and procedures, which included PCR (nasal swab) on 15Mar2021 and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events vaccination site pain and vaccination site swelling, fatigue, chills, fever, muscle pain, joint pain and appetite lost was recovering at the time of this report. Information on the lot/batch number has been requested.

Patient has been having abdominal cramping with uncontrollable diarrhea for three days following his first COVID vaccination. He is eating a bland diet with yogurt, but has been passing bloody, loose stools every 30-40 minutes. He notified his PCP, who prescribed him an antibiotic for possible diverticulitis flare.

01/22/20When transferring resident from bed to W/C Resident became unresponsive to voice with eyes fix open and point up to the right. Placed resident back in bed found 82% o2 sats B/P 110/106 pulse 110 resp below 16 placed o2 via non rebreather with 20 l/min 02 up to 90% then stabilized at 89% Resident following all commands encouraged to take do breathing exercises, with some compliance, continues ABT/pneumonia , no s/s adverse 1/23/2021 16:48 Discharge Summary Note Text: Resident found unresponsive with no pulse or respirations in bed with emesis on gown. Time of death verified at 1645 with LPN. Funeral Home called at 1900 and body released at 2000.

28 January 2021 To : Vaccine Adverse Event Reporting SystemO Im am writing to report a possible adverse reaction . On Wednesday, January 20, 2021, at 9:22 AM, I received my first dose vaccination of Pfizer COVID-19 Lot# EL3247 at the Health Clinic Site. At approximately 4 PM that afternoon I experienced the first of a number of episodes of watery, gassy, non - bloody diarrhea which was heralded by great urgency but was accompanied by neither fever, abdominal pain , nor any other systemic signs or symptoms. There was no anosmia, headache, nor respiratory difficulty. I continued to feel clinically well and I had no change of my daily activities. I experienced no change of appetite. I experienced two or three such urgent episodes daily for the next eight days. At no time during that week did I have a formed stool. I cannot recall the last prior episode of watery . gassy diarrhea since it is not an experience which I have experience for, likely, decades. During the 7-8 day period, my wife and I ate exactly the same foods. My wife experienced no diarrhea, cramping of frequent stooling. She reports that all of her stools have been normal. After three or four days, I spoke with several internists who suggested that I obtain a SARS-CO-V-2 NAT, NP Swab test. Since I had been symptomatic for a number of days. I self quarantined and moved out of my wife?s and my bedroom. During all that time I wore a face mask and increased the frequency and duration of hand washing. NO SARS-CoV-2 RNA was detected by PCR. It is now 48 hours since my last watery, gassy stool. I have just passed a normal appearing, non -melanotic, formed stool. Sincerely, Patient

Arm very sore chills for one night fever for one night loss of appetite general feeling of not feeling well general feeling of fatigue second day/ feeling slightly better but not back to normal

not feeling too good; not able to sleep at night; loose stools; chills; nausea; low grade temperature; sinus issues, like drippage causing him to swallow the mucus all through the night; sinus issues, like drippage causing him to swallow the mucus all through the night; like a tickle in throat and he was coughing; like a tickle in throat and he was coughing; joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area.; joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area.; Slight headache; A little fever; Bowel movement soft; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date not reported), intramuscular at the left arm on 20Jan2021 14:00 at single dose for COVID-19 immunisation. Medical history was not reported. The patient was vaccinated at a clinic. Concomitant medications included clopidogrel bisulfate (PLAVIX), losartan, hydrochlorothiazide, amlodipine, metoprolol; all were ongoing. The patient previously took a flu shot (INFLUENZA VACCINE) on 18Dec2020. On an unspecified date, the patient was not feeling too good, was not able to sleep at night, loose stools, chills, nausea and low grade temperature. On 20Jan2021, the patient experienced sinus issues, like drippage causing him to swallow the mucus all through the night and had like a tickle in throat and he was coughing, had joint pain in his wrist, shoulder, knees, ankles, and lower back in lumbar area, slight headache, a little fever, and bowel movement soft. Clinical outcome of cough, slight headache and little fever was recovering, while for the other events was unknown.

Nausea; aches; tiredness; This is a spontaneous report from a contactable consumer (patient). A 83-years-old male patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9261) , via an unspecified route of administration on 21Jan2021 18:30 at SINGLE DOSE at left arm for covid-19 immunisation . The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced nausea, aches, tiredness on 22Jan2021 17:30. No treatment for the events. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination; No covid tested post vaccination

Nausea and vomiting that started a little the day of but mostly the following day and that has now persisted daily for 11 days.

Patient's wife reported via telephone conversation with current nursing staff that patient had presented outpatient this morning around roughly 10:30AM, where he received his Covid-19 vaccination. He then went grocery shopping with his wife, and presented to home, where he began having notable difficulty swallowing and increased confusion, family had then sat him down in living room chair, where his daughter noted acute onset of tongue, upper/lower lip swelling, and right eye drooping. Patient's wife reports that he typically manages all of his home medications by himself, and manages his own ADL's without assistance at home. She reports that he did miss his noon dose of Sinemet, otherwise he has not missed any doses of current prescribed medications, and denies any recent start/change to current medication regimen, or OTC medications. Patient had difficulty swallowing scrambled eggs

RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/12/21 ON 02/20/21 REPORTED TO ED AFTER BECOMING LIGHT HEADED AND HAVING A SYNCOPAL EPISODE. REPORTED SOME SOA ON EXERTION THAT DEVELOPED EARLIER THAT DAY. ON 02/20/21 PT ADMITTED INPATIENT TO HSOPITAL WITH DIAGNOSIS OF SYNCOPE AND COLLAPSE, AOMMUNITY AQUIRED PNEUMONIA, ACUTE COLITIS, AND LEUKOCYTOSIS.

Resident is a Hospice patient. On 1-23-2021 am shift resident was observed by nursing have chest congestion and had a emesis times 1 with SOB, Zofran 4 mg was given. HOB (02 sats 88%) was elevated resident on 02 via nasal canula with 02 sat now @ 90% . no respiratory distress noted. MD was called with response pending for orders. @ 1400 resident with no signs of life. vs 90%-24-97/71-97.6. Hospice on site and time of death 1436

At 8:30am, 2/26/21, He was asleep on chair in dining room. Very hard to wake him up! I got him to a recliner, but then he had to throw up. He said he was "foggy" and went to sleep when he got back to the recliner. At 11:45am, his blood pressure was 66/47, then 71/48 in his left arm. In his right arm, 74/51. He did have some top ramen soup and was feeling better. I took his temperature earlier and it was 96.1.

The pains across his body keeps getting worse, the pains got a little better Saturday but then Saturday night it got pretty bad.; Loss of taste; difficulty talking; Friday night the same thing happened except the pains were a little higher and above his belly button; pain across body; little bit of soreness in left arm; This is a spontaneous report from a contactable consumer (patient). This 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number EL9261, exp. unknown) , intramuscular on left arm on 21Jan2021 08:30 at single dose covid-19 immunization at a clinic. Medical history included thyroid disorder from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included levothyroxine 100mcg once a day for thyroid. The patient experienced little bit of soreness in left arm (non-serious) on 21Jan2021 with outcome of recovered, pain across body (non-serious) on 28Jan2021 20:00 with outcome of recovering , the pains across his body keeps getting worse/the pains got a little better Saturday but then Saturday night it got pretty bad (condition aggravated) (non-serious) on an unspecified date with outcome of unknown, loss of taste (non-serious) on 01Feb2021 with outcome of unknown, difficulty talking (non-serious) on 31Jan2021 with outcome of not recovered , pains were a little higher and above his belly button (non-serious) on 29Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included thyroid function test was low on Sep2020 (levothyroxine was changed to 125mcg from 112mcg), thyroid function test was back towards normal but had not quite reached it on Nov2020 (new dose of 100mcg tablet once a day), thyroid function test was unknown on 25Jan2021 but was on 100mcg of levothyroxine once a day. Therapeutic measures were taken as a result of little bit of soreness in left arm and pain across body included Tylelol (acetaminophen).

some temporary diarrhea; felt tired; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247, expiry date: unknown), via an unspecified route of administration on 30Jan2021 (at the age of 83 years old) at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on unspecified date at a single dose for covid-19 immunization. On unspecified date in 2021, the patient experienced some temporary diarrhea and felt tired for about 15 hours. Outcome of all the events was recovered on unspecified date in 2021.

Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). An 83 -year-old male patient receieved bnt162b2 (BNT162B2) , intramuscular on 2Jan2021 09:30 toat SINGLE DOSE for an COVID-19 immunizattion. Medical history included lung disorder from an unknown date and unknown if ongoing had some lung issues in the past. She said that he was hospitalized in Jan2020 for something really odd , cough, pulmonary oedema , atypical pneumonia, mycobacterial infection; Couple of years ago and had to take some IV medications through a PICC line and that was about 2 years ago and it has cleared up. There were no concomitant medications. The patient experienced nausea and dizziness on 13Jan2021 04:00 The outcome of events was recovered.

He started vomiting 2 days later. we suspect he was having stool issues as well. he vomited blood at some point over the weekend. there was black vomit right before he passed. from 2am-6am he was wheezing and rattling and then he passed at approximately 6am 3/1/2021 at home. EMS did come and try to revive him and were unsuccessful.

Received first dose on afternoon of 1/22/2021. No apparent side effects initially. Then in early morning hours of 1/25/2021 he woke up throwing up, then dry heaving. Found some Tums (only thing we had) and gave that to him. He went back to bed and went back to sleep - nothing further for 3 days. Then on 1/28/2021 he again began feeling nauseous and ran to the bathroom and vomited. Again, it lasted a short time and was over. Since then there have been 2 other episodes of random nausea, but this time without vomiting. This is from a man who does not throw up EVER. Then, sometime after the first shot, which was received 2 days after we returned from a trip to see family, he began having explosive diarrhea. Up until this time he had been suffering (for months or years) with chronic constipation - which we had been working with the doctor with to alleviate. I do not know the exact date this started, as it is not the kind of info Dad was keen to share, but I do know that it was NOT happening before the vaccine, as we were traveling and I would have had to make emergency stops for him (this has been so bad he has at times had to change clothes because he could not get to the restroom from his living room). As I became aware of it I began gradually taking him OFF stool softeners and osmotics we had him on, to the point that he now takes NOTHING and yet he still has explosive diarrhea DAILY and multiple times.

he has a congested cough that has increased recently; nausea; fatigue/ still very tired; He had chills; fever/ mild temperature; This is a spontaneous report from two contactable consumers (patient's wife and patient himself). An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EK4176, expiry date Jul2022) via an unspecified route of administration in arm right, at the age of 83-year-old, on 26Jan2021 12:00PM, SINGLE DOSE for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease (for 15 years or more), ongoing spinal stenosis in his lower back for about 15 years or more, and rotator cuff syndrome (left arm). Concomitant medication included ongoing sertraline hydrochloride (ZOLOFT). The patient did not receive other vaccines within 4 weeks. The patient experienced nausea on 28Jan2021 with outcome of not recovered, fever/ mild temperature on Jan2021 with outcome of not recovered, fatigue/ still very tired on 28Jan2021 with outcome of not recovered, he had chills on 28Jan2021 with outcome of not recovered, he has a congested cough that has increased recently on Feb2021 with outcome of not recovered. The patient went to his eye doctor for an eye exam, and he was not real comfortable because he was semi-nauseous. The patient had experienced fatigue, tiredness, and nausea since receiving his first COVID-19 Vaccine dose. The patient reported he also had chills. The patient had an increase in a congested cough recently. The patient continues to feel fatigued, tired, and nauseated. The patient felt like he should have gone to the Emergency Room, or seen his doctor when he experienced the side effects after the vaccine, but he didn't go. The patient has been taking cough medicine. The patient has COPD and takes the cough medicine at night before he goes to bed. The patient clarified that he started taking the cough medicine because he had an increase in a congested cough recently. The patient clarified he has a sticky, yellowish phlegm that he coughs up. The patient said recently the phlegm changed to a reddish-brown color. The patient said his phlegm will go back and forth from the yellowish color to a dark brown color. The patient said he started the cough medicine about a week or so ago. The patient said it was a 4 ounce bottle of cough medicine. The patient said he takes a 20ml dose at night, so he doesn't start hacking while he sleeps. The patient just finished the 4 ounce bottle of cough medicine last night. The patient takes over-the-counter Tussin DM Max cough medicine. The patient is scheduled for his second COVID-19 Vaccine on 15Feb2021.

Blood in stool; Diarrhea; Severe weakness; Dizziness; Slurred speech; This is a spontaneous report from a contactable consumer (patient's daughter). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 at a single dose for covid-19 immunization. Medical history included ongoing high blood pressure and enlarged prostate. Concomitant medications included lisinopril taken for high blood pressure from an unspecified date and ongoing; tamsulosin taken for enlarged prostate; and amlodipine taken for high blood pressure. The patient had side effects: blood in stool, coupled with diarrhea on 02Mar2021, severe weakness and dizziness on 01Mar2021, and slurred speech in2021. The patient felt fine during the day and was able to exercise and it was in the evening of 01Mar2021, that he started to feel the weakness and dizziness. It was followed by diarrhea and he started to get some blood in his stool. The patient's daughter took him to the hospital on 07Mar2021. They were still diagnosing him now. The patient's daughter said that he was still having the weakness, but he has not really eaten anything. Outcome of events blood in stool, severe weakness and diarrhea was not recovered, reported as ongoing; event dizziness was recovered on 04Mar2021; outcome of other event was unknown. The patient was hospitalized from 07Mar2021 and ongoing for the event blood in stool. Information on lot/batch number has been requested.

Dizzy, throwing up, sore arm, chills, sweats, headaches, loss of appetite, could not stand due to dizzy or open eyes, temperature variance from 97 to 100.

Resident began to feel ill at 2:30 am the night after he received 2nd dose of COVID vaccine. Suffered from weakness, chills, and nausea. Felt ill for approximately 2 days, but then symptoms subsided.

Patient's immune thrombocytopenia was quiescent 15 months but relapsed 2 weeks after receiving first and only dose of Pfizer Covid vaccine. Non-critical GI bleed. Also neutropenia. Treated with IVIG and high dose prednisone with response.

PRIOR to receiving the 2nd covid-19 Pfizer vaccine had a bowel movement each day after each meal- 3x/day everyday. 03/17/21- The day after the vaccine, bowel movements stopped completely. Became bloated with severe abdominal pain, shortness of breath and difficulty walking due to pain. Tried OTC stool softeners, miralax, prune juice and no relief. Seen in ER on 03/20/21 for abdominal pain, bloating and constipation. CT scans did not provide answers. Seen by GI specialist and had colonoscopy and EGD on 03/29/21 which did not provide answers on sudden stop of bowel movement. Almost a month later still not having bowel movements regularly despite taking Linzess as prescribed, still have abdominal pain and bloating daily, difficulty eating due to bloating and pain, have lost 7 pounds in the past 3 weeks and now remaining in bed more throughout the day due to pain/bloating. Becoming depressed and irritable which was NEVER a problem prior to the 2nd Pfizer covid-19 vaccine.

Lightheadedness/almost fainted; Nauseous; Headache; fluish sick; This is a spontaneous report from a contactable consumer (patient). An 83-year-old male patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Feb2021 11:30 (Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included artificial heart valve from Jun2018 and ongoing, transient ischemic attack (TIA), high cholesterol, blood pressure (abnormal), all from an unknown date and unknown if ongoing. Concomitant medications included apixaban (ELIQUIS) tablet taken for transient ischemic attack from Oct2019 and ongoing; rosuvastatin tablet taken for high cholesterol from an unspecified start date and ongoing; metoprolol caplet taken for blood pressure from Nov2020 and ongoing. The patient previously received first dose bnt162b2 (BNT162B2), administered in Arm Left on 22Jan2021 13:00 (Lot Number: EL9263) for COVID-19 immunization. Patient was reporting reaction to Pfizer COVID vaccine. Patient stated he read some articles to call and reported if you have a type of reaction or something after having the COVID vaccine. Patient had second COVID vaccine on 14Feb2021. Three or four days later (as reported), he began feeling lightheaded, nauseous and headaches beginning around 18Mar2021 or 19Mar2021. Patient reported he almost fainted a few times and it had gotten progressively worse. The patient reported having headaches not every day, but pretty much close to every day, 4 out of 5 days a week. Patient reported sometimes the headaches were bad and sometimes constant. Patient was hospitalized and had every test known to mankind. The patient reports actually being kind of fluish sick for 2 days after having vaccine, the normal feeling that every one says they have. He completely recovered; started night of the 14Feb2021, lasted next two days and then totally gone on 16Feb2021. Blood thinner stopped a couple of days before the shot per his doctor. Patient stated that every test he had was negative, nothing that would cause the symptoms. He had a Computerized axial tomogram (CAT) scan with dye; CAT scan without dye; carotid artery tested; echocardiogram; left the hospital said they didn't find anything to cause it. After talking to people and reading, he decided to call Pfizer. All results came back negative. Vaccination Facility Type was community center - other. Vaccine was not administered at Military Facility. No additional vaccine was administered on same date of Pfizer COVID vaccine. No additional vaccine was administered. Adverse events lightheadedness, nauseous, headache required a visit to Emergency Room. The patient was hospitalized for 2 days from 29March2021 to 31March2021 due to lightheadedness, nauseous, headache. The outcome of event fluish sick was recovered on 16Feb2021, of other events was not recovered. Follow-up attempts were completed. No further information was expected.

Awoke with extreme dizziness. Over next few days, blacked out 3 times. Vomited 3 times. Remained in bed much of the time for a week. Constant tinnitus (still present). Current working diagnosis: Vestibular Neuritis and Labyrinthitis. Still have significant problem with balance (current date - 05/10/2021)

Presented to ED ~ 12 hours after receiving 2nd Covid vaccine. Chief Complaint: FEVER. (Pt had second COVID vaccine around noon. He presents via ambulance " feeling terrible" with fever, malaise. He is somewhat confused and uncomfortable here. Daughter in law here). No muscle aches, chest pain or cough. He has had loss of appetite. He has had dyspnea (chronic). He has had altered mental status (mild confusion). He has had skin rash (chronic LE). Pt was kept for observation x3. He was given IV fluids and a started 4.5 gm of Zosyn (Piperacillin Sod-Tazobactam So). Diagnosed with pneumonia - switched to oral augmentin at discharge. On home oxygen.

Pt w/hx significant for B-cell lymphoma & interstitial lung dx (on 4L O2 at baseline) p/w 5 day hx of SOB, cough, congestion, and diarrhea. COVID test was positive (6/15) despite receiving Pfizer vaccines (1/15 & 2/6). Was admitted for acute on chronic hypoxic respiratory failure secondary to COVID-19 pneumonia. Received dexamethasone, plasma, and tocilizumab during admission with improvement, however, pt is still hospitalized and feels SOB w/any exertion and desaturates w/cough.

1 week of nausea, vomiting, and diarrhea and worsening dyspnea. His respiratory status decompensated since admission. He was initially on 2-3 L nasal cannula and then worsened to needing BiPAP at 100% FiO2. Even with that, his SpO2 was between 88-90%. He was transferred to another hospital for further management.

Pain @ injection site; muscle pain, shortness of breath, fast heart beat, difficulty breathing, vomiting at 4:45 am and at 5:40 am on 1/16/21.

Headache; Nausea/feels like he wants to throw up; his stomach hurts; This is a spontaneous report from a contactable consumer (patient's wife). An 84-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), intramuscularly on 10Jan2021 10:00 at a single dose for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient was previously administered with flu shot (INFLUENZA VACCINE) for immunization and he got sick. The patient experienced headache, nausea; further reported as he feels like he wants to throw up and his stomach hurts; all on an unspecified date. Outcome of the event "headache" recovered on an unspecified date, event "nausea" was not recovered while the event "his stomach hurts" was unknown.

The following morning, he experienced headache and loose stools./had really loose stool and was squirting liquid/ diarrhea; The following morning, he experienced headache and loose stools.; arm soreness; He still has some loose stools but was no longer "squirting" and still had a feeling in the bottom of his stomach like he needs to go to the bathroom; This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration on left arm on 12Jan2021 at a single dose for COVID-19 vaccination. Medical history included Chronic obstructive pulmonary disease (COPD) (he has had it for years. He says he uses a machine when he goes to bed, a mask). The patient's concomitant medications were not reported. The patient previously took flu shot (unspecified) one injection a few (also reported as 3) weeks ago. The patient received the Pfizer-BioNTech COVID-19 vaccine on 12Jan2021 in the evening about 05:30-06:00PM. The following morning on 13Jan2021, he experienced headache and loose stools. The loose stools were described as "squirting" of over the next 5 days and then the loose stools started to improve. He says starting Wednesday he had really loose stool and was squirting liquid and it has bad for about 3 days. He says Saturday he started having loose, real loose stools, not squirting, but this has gone through to today. He says he still has a feeling kind of like he needs to go to the bathroom all the time. He says he never had a loose stool as far back as he can remember before, he didn't take anything for it, his doctor isn't giving the vaccine so he didn't contact him. He says he also didn't want to mess up by taking anything. He was squirting and had loose stool Wednesday morning and then that continued until today, he was not squirting, was having very loose stool, that was better, since he was not squirting. He still has some loose stools but was no longer "squirting" and still had a feeling in the bottom of his stomach like he needs to go to the bathroom. The headache gradually improved after the initial injection and he only has a little headache left currently. Patient had a headache the first couple of days, it was real light until now, he was still kind of not back to normal. He wanted to know if this will go away, since he is due for next virus shot in a week or so and was kind of dubious about taking it. On unspecified date in Jan2021, the patient had arm soreness that went away and was gone, he was sore for a couple days. The outcome of the events diarrhea and headache was recovering; event "He still has some loose stools but was no longer "squirting" and still had a feeling in the bottom of his stomach like he needs to go to the bathroom" was not recovered; and arm soreness was recovered in Jan2021.

Woke up about 2:30 AM with uncontrollability with bowels and urinary. Black ink like stoll. Chills and Sweating, Joint and Bone pain. Dizziness on arising, unsteady in Walking. Lasted for 2 days before subsiding. Still remain weak on 2//4/2021. Second shot due on 2/16/2021 Same Faculty.

At midnight started with chills, shaking in his shoes. Got up the next morning, was not feeling good. Went out for a little while and realized that he was cold. Went to bed for about 30 hours with a little nausea, but not feeling right. Took Tylenol every 6-7 hours during that interval of time. Feels good now.

felt weak; Dysentery; violently sick; throwing up; dehydrated; dry heaving; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: E18982, expiration date was not reported), intramuscular on the left arm (also reported as left shoulder) on 15Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. It was reported that the patient was taking an unspecified blood thinner and other unspecified products. It was reported that patient got the first dose on 15Jan2021 and everything was fine. The following Friday, exactly a week later, on 22Jan2021 at 930am he got violently sick as far as throwing up and dysentery. He was asking if it could be from the shot. He got sick and was heaving for 7 hours, then he was dry heaving after throwing up so much, it was green bile. He knew he was getting dehydrated and drank a bottle of Pedialyte at 7pm that night. He had to stay a half hour after getting the vaccine since they wanted to monitor him a little longer since he takes blood thinners an other crap. He did not specify the other medications that he takes. On Saturday he felt fine but he felt weak. The patient recovered from dysentery and throwing up on 23Jan2021, while outcome of the remaining events was unknown.

Severe attack of shivering, followed by increased pulse rate - 70 to 120, loss of stability, stiffness in joints, tiredness, loss of apatite. Treated with extended sleep. Stiffness lasted 20 hr and was treated with Ibuprofen

At midnight developed heart burn, low BP but normal O2; at 4am took Antacid then felt better and BP was normal. Then around 7am asked to go to ER because the discomfort became pain and moved to the side. Went to ER, mild Cardiac issue and at 3pm had heart attack and passed away.

Per patient, the evening after dose 1 he developed throat discomfort, difficulty swallowing, and shortness of breath. The pain was moderate but main issue was difficulty swallowing. He did not seek medical attention but took tylenol. Symptoms self-resolved.

my temperature and it's at 99.3 F/a little fever; weak; I didn't have appetite; This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9264) via an unspecified route of administration on the left arm on 08Feb2021 at a single dose for COVID-19 immunization and apixaban (ELIQUIS) via an unspecified route of administration from an unspecified date and ongoing at an unspecified dose and frequency for an unspecified indication. Medical history included afib and heart rate (abnormal). Concomitant medication included propranolol hydrochloride (MANOPROLOL) for afib. The patient previously received first dose of BNT162B2 on 18Jan2021 for COVID-19 immunization (lot: EL1283 on the left arm) and experienced a little bit of soreness at the injection site. The patient took his temperature and it was at 99.3 F. Patient asked, "Is that within range? Can I take Tylenol?" The patient stated that when he first got his shot of the Pfizer Covid Vaccine at the (Hospital name) in (City name) he didn't have any problems or didn't experience any side effects. Then after receiving his 2nd shot on 08Feb2021, he mentioned that he started having trouble. On 10Feb2021, he started to experience some side effects and stated, "I was as weak as I could be, I didn't have appetite and I had a little fever. I just feel super weak but not like if you have corona. Now, I can sleep under oxygen and it doesn't bother me anymore and when I get up I don't need oxygen anymore and I can breathe freely." Wanted to know how long will his symptoms last. He was as weak as a rag, has a little fever that comes and goes, does not go over 101, stated he was taking Eliquis does not know if that was important or not, slept with oxygen but has not had any trouble breathing. Wondering if this was standard. The action taken for apixaban was unknown. Outcome of the event 'didn't have appetite' was unknown and not recovered for the other events.

The patient presented to the ED on 3/11/2021 with fatigue for a few weeks, and recent abdomen pain. The patient was found to be hyponatremic and there was also evidence of a CVA on MRI findings.

Received 2nd dose of covid19 vaccine on Wednesday 3-24-2021, felt fine Thursday, Friday loss of appetite tired, Saturday lethargic could barely function on his own. Sunday morning lethargic, weak, could not walk very well, complained of shortness of breath. Called 911 and took to emergency room. White blood count off, platelet level low, 14,000

Light headness, Loss of appetite, overall listlessness, slight nausea, fever 101.6, dramatically excessive sweating,dark urine. Spent the next 24 hrs in bed.

The information was presented by his granddaughter. He was scheduled to come in for his second vaccination with his granddaughter on 4/14/21, however, he passed away on 4/13/21. His granddaughter stated he experienced a severe nose bleed just under a week post vaccination (1st dose/Pfizer). The nose bleed lasted a few hours and had to be controlled by the Hospital. The incident reoccurred a week later and again, the bleeding had to be controlled by nasal clamp and lasted for a few hours. The patient began having pain in his stomach and feet, and stayed pale and nauseous. On 4/13/21 the patient was found in his bed saturated in blood and had soiled himself. His family called EMS and the patient went to Hospital. The patient coded and was not revived. The granddaughter stated that he had an enlarge prostate that was discovered during one of his hospital visits in the past 3 weeks.

Sudden diarrhea; This is a spontaneous report from a contactable consume (patient). A 84-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via an unspecified route of administration in right arm on 03Feb2021 at 09:45 as single dose for COVID-19 immunization. Medical history included chronic kidney disease. Concomitant medications included Symbicort, Montelukast SOD, Terazosin, Famotidine. Historical vaccine included BNT162B2 (Lot unknown=False, Dose number=1) for COVID-19 immunization. On 05Feb2021, the patient experienced sudden diarrhea. Outcome of the event was recovered on an unspecified date 2021. Information about lot/batch number requested.

I develop pains, severe pain in my stomach; They come and go but not the severe is the pain that I had at 4 O' Clock; This is a spontaneous report received from a contactable consumer (patient). A 84-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9265; Expiration Date: 31Mar2021), via an unspecified route of administration on an unspecified date (at 9:05) as SINGLE DOSE (84 years at time of vaccination age) in left arm for covid-19 immunization. Medical history included: open heart surgery on 22Jan2018 and Quad trupha henry surgery. The patient's concomitant medications were not reported. On 01Feb2021, the patient developed pains, severe pain in stomach at 4 O'clock this morning after the 5th day of bnt162b2 vaccination. They come and go but not the severe is the pain that he had at 4 O'clock. The patient was wondering is this normal and if it is when can he expect some relief from the stomach and if he could take to anything to elevate the pain. The patient did not receive any treatment for the event. The patient did not visit physician Office/ Emergency Room. The outcome of event stomach pain was recovered on an unspecified date 2021. Information on the lot/batch number has been requested.

her husband was really sick; he is still weak from it; horrible diarrhea; vomiting; This is a spontaneous report from a contactable Consumer. A 84-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration in right arm on 03Feb2021 (at 84-years age) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter confirms that her husband received no other vaccines on the same day as the COVID vaccine. On 04Feb2021, the patient received the first dose of the vaccine and experienced diarrhea and vomiting on. The reporter wants to know if the patient could get this after the second dose, too. The reporter also enquired if someone does not have side effects from the first dose, could they get them from the second dose and wants to know what would happen if she delayed her second dose. Two weeks after receiving the first dose patient had a very bad reaction. The reporter wants to know if her husband would experience the same if he received the second dose. The reporter states that her husband no longer has the vomiting and diarrhea, but he was still weak from it. The patient took Imodium AD, because he could not leave the house to see his doctor, because the diarrhea was so severe. The outcome of event diarrhea and vomiting was resolved on 14Feb2021, for weakness was not resolved and for illness was unknown.

Tired the day after shot, then a week or so later, began c/o mild nausea and mild headache .. comes and goes ... Off and on until this past week when he really hasnt felt like doing anything, legs feel week, short of breath more than usual and BP is sometimes LOW for him ...104 / 60 with lower pulse at 45 or 50 instead of his consistent 66. Also , has had intermittent dizzy, foggy head or wobbly legs.

Hospital 5/22 thru 5/24/2021 Dx: UTI/ Weakness/ Right Pleural Effusion Covid Positive (5/22/2021) ED to Hosp-Admission Discharged 5/22/2021 - 5/24/2021 (2 days) Treatment team UTI (urinary tract infection) with pyuria Hospital Problem List Generalized weakness Resolved Pleural effusion on right Resolved UTI (urinary tract infection) with pyuria Resolved Lack of appetite Resolved UTI (urinary tract infection) Resolved Constipation Resolved Intractable vomiting with nausea Resolved

slight chills; diarrhea; sore; heavy mucus/getting mucus in the back of the throat; weight went down; This is a spontaneous report from a contactable consumer (patient). A 84-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208), via an unspecified route on 09Mar2021 at 13:30 (at the age of 84-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included high blood pressure, high cholesterol. The patient concomitant medications included losartan with dose 100 mg, 1x/day for high blood pressure and rosuvastatin with dose 20 mg, 1x/day for high cholesterol and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Mar2021, the patient experienced getting a lot more mucus in the back of the throat. Patient stated it had been getting a lot more in the last couple of days. On 10Mar2021, the patient experienced sore the next day a little bit, on 17Mar2021 patient experienced diarrhoea and at 03:00 in the morning slight chills. He said that his weight went down since the diarrhoea. He said that he usually weighs around 220llbs. He said that he had shrunk with his age. Patient stated that he had to get up every hour at night and found a book called Remedies and it said something about carrot juice and also said something about blueberries. He said that he crushed up some blueberries and ate them and it went through him like roto-rooter. He said that he only had one episode of diarrhoea last night. He said that it seems more semi solid now and had slowed down. He said that the mucus seems to have slowed down now. He said that his second dose is due on the 30Mar2021. The patient did not visited emergency room or physician office. The outcome of events getting mucus in the back of the throat, diarrhoea was recovering, chills was recovered on 17Mar2021 and other events was unknown. No follow-up attempts are possible. No further information is expected.

Wife calling to report patient being sick for one week, not eating, has cough & diarrhea. Reports to Emergency room and is admitted to hospital.

Patient admitted to hospital 7/28/21 diagnosed with COVID-19. Symptoms started 7/18/2021 and positive Covid-19 test 7/21/21. Repeat Covid-19 test on 7/28/21 to confirm diagnosis. Patient reports symptoms of nausea, nasal drainage, cough with yellow-green sputum, increasing SOB, generalized weakness, dry heaves.

vomiting later on 01/05/21. Lethargy and hypoxia in pm of 01/06/21. Hypotension am of 01/07/21. Hospitalized, intubated, cardiac arrest, died 01/07/21.

Had fallen early morning the day after the injection. At approx 12 noon, was eating lunch and became nauseous, diaphoretic, vomiting and ashen. Complained of chest pain. EMS activated and sent to ER for further evaluation. Cardiac work up completed and within normal limits. returned to facility. ER note: ?Very likely musculoskeletal in nature (maybe from recent Covid vaccination?

Passed out; massive diarrhea; fell and hit his face; fell and hit his face; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Medical history included epilepsy from an unknown date and unknown if ongoing (Caller says her father in law hasn't had seizure in years, it was diagnosed when he was a kid, 60-70 years ago). There were no concomitant medications. The reporter is calling on behalf of her father in law. She said he had his first dose of the COVID vaccine recently, she pulled this number off of the paperwork today. She says that she believes he had a side effect for it, and also he was rescheduled for his second dose. She says his second dose was supposed to be in 21 days but they rescheduled him for it at 18 days instead. She says he got the first dose on 11Jan, and they rescheduled his next for the 29th. She says she wanted to know if this was correct or ok. The reporter says that the following day he ended up having massive diarrhea, that it caused him while he was on the commode to pass out and he fell and hit his face, the best she can tell he was alone at the time. She says he did not go to the hospital for that, he got up and cleaned himself off and took a nap, and the nurse next door checked on him later on. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Pfizer-BioNTech COVID19 dose #1 given IM LD at 10:30AM 1/27/21. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting. While seated, vital signs were taken- BP 148/76, HR 73, O2 98%. No falls or medication administered. EMS arrived around 11:10am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on EMS assessment, recommenedation was to go to the ER. Patient brought to Sharp Memorial Hospital by EMS staff at 11:20am, spouse was present and in agreement.

Trouble swallowing: 30 hours after shot, continuing though current time of 70 hours Nausea, vomiting, dizzy, fainting 65 hours after shot. 2 episodes Fever - 72 hours after shot

Heart stopped; Could not swallow; This is a spontaneous report from a contactable nurse (patient's wife). An 85-year-old male patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. Medical history included blood pressure abnormal (verbatim: blood pressure) from an unknown date and unknown if ongoing, neuropathy from an unknown date and unknown if ongoing, weight issue from an unknown date and unknown if ongoing, diabetes from an unknown date and unknown if ongoing, walker user from an unknown date and unknown if ongoing. Concomitant medications included insulin aspart (NOVOLOG) taken for diabetes from an unspecified date to an unspecified date; and he was taking a long acting one as well. The patient previously received the influenza vaccine (MANUFACTURER UNKNOWN) for immunization on unknown dates ("had flu shots before with no reactions and everything, nothing before"). On 24Jan2021, the patient's heart stopped (death, medically significant), and could not swallow (medically significant). The clinical course was reported as follows: The patient's wife stated the patient was taking insulin aspart (NOVOLOG) and he was taking a long acting one as well. The reporter, the patient's wife and a retired registered nurse (RN) stated, her husband (patient) just died and she thought he died from the COVID vaccine (later clarified the reason of death was-heart stopped). The patient had the vaccine on 21Jan2021, which was on a Thursday, and he was fine. On the following Sunday around 1:30 (on 24Jan2021), the patient was feeling a little weak, however, the patient's wife thought maybe his blood sugar was low. The patient's wife checked, and the patient's blood sugar was 91. The patient's wife went to get some yogurt to feed him in order to get his blood sugar up a little; "which was a normal thing for him, it was not that low for him." Then, suddenly, the patient fell, and the patient's wife could not get a pulse or anything. The patient's wife called an unspecified number and she started compressions; however, he was dead. The patient's wife stated the patient just had his heart test, a three hour long one, and it was "perfect three weeks ago." The patient had just gone to the doctor the other day and his blood pressure was "fine and everything." The patient's wife stated that other than his diabetes, "which he had for (sentence incomplete)." Regarding lab tests, the patient's wife stated, "No, he had it before but not in the last two weeks. He was going for one because we just went to the doctor last week and he was going to call yesterday to make the appointment request to get his blood work done. Blood work has been good except his A1C was always high, but other than that everything was good" (as reported). Regarding causality, the patient's wife stated, "I do, because he was fine until about half an hour before he died. He said to me, I feel a little weak today and then I was talking to him that your upper body strength is really good and then I said, we just have to work on your weight a little more because he did have neuropathy. And then, I went out of the room and all of a sudden I just heard him fall and that is when I just went in to check his blood sugar and it was 91 and I got him yogurt and he started eating that and then that was it, he started spitting it out and he said, I could not swallow and that was it, he just died." The patient's wife further added, "I just wanted other people to know that things like this happen and I am sure it was from that because he was healthy as could be. He was walking with his walker, the day before outside and he felt fine." The clinical outcome of the event, heart stopped, was fatal. The clinical outcome of the event, could not swallow, was unknown. The patient died on 24Jan2021 due to "heart stopped." An autopsy was not performed. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Reported Cause(s) of Death: Heart stopped

3 days after the shot he started getting flu-like symptoms. This included headache, diarrhea, tiredness, weakness, severe muscle aches, loss of appetite. Contacted his cancer dr. and was told to stop the Calquence for 3 days, drink 8 - 8oz of water a day (which he could not do and threw up after drinking), and to start taking Immodium, which he did.

1/14/2021-0545, blood noted left and right ear. 0715, vomited x 1. Covid Antigen positive. Acute MD visit-basilar crackles right and coughing. Increased confusion.

unresponsiveness for 2 minutes in seated position; bilateral arm tremor; pallor; eyes rolled back; drooling; nausea; vomiting; This is a spontaneous report from a non-contactable pharmacist. An 85-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9262), intramuscular on 27Jan2021 10:30 AM at single dose on Left arm for covid-19. Medical history included anaphylaxis history of unknown cause. The patient's concomitant medications were not reported. 30 minutes into observation, patient experienced bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness for 2 minutes in seated position on 27Jan2021 11:00 AM. 911 called immediately. Patient became alert and oriented after 2 minutes but experienced nausea and vomiting on 27Jan2021 11:00 AM. While seated, vital signs were taken- BP 148/76, HR 73, O2 98% on 27Jan2021. No falls or medication administered. (name withheld) arrived around 11:10 am and assessed cardiac rhythm and vital signs. Patient initially wanted to go home, but based on (name withheld) assessment, recommendation was to go to the ER. No treatment received. Outcome of events was recovered on 27Jan2021. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to the events bilateral arm tremor, pallor, eyes rolled back, drooling and unresponsiveness is possible. 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.

constipation for 3 days following shot. medical treatment; daily fiber drink, suppository. and sttol softner.finally had a movement Sunday, 01/17/2021. 2nd shot on 02/03/2021 had same effect but I was prepared and medicated for it.

Patient had no energy in the first 24 hours and then began a steady decline that started with vomiting after 48 hours, then an inability to swallow and ultimately the patients death on 2/5/21.

No adverse effects for the first two weeks. The morning of 2/7/21 he claimed he was not able to sleep the night before. He was cold, but only wanted something cold to drink. He was not able to get through his normal morning routine. By 8 am we was beginning to get confused and weaker. By 9 am he vomited and was not able to stand up or walk. The confusion was increasing. We called 911. When they arrived he had chills and was agitated. He did not have a fever at that time. He was transported to the emergency room. We were not able to accompany him there, but were told he was confused, agitated and combatant. His fever was up to 101 degrees. The started him on antibiotics and began tests. He tested negative for COVID and the flu. By that evening they diagnosed him with viral meningitis and admitted him to the hospital. The next day we were told that they had ruled out viral meningitis as well as other infections. The infectious disease doctor said that all tests had come back negative, but they were continuing to give him antibiotics. A neurologist and cardiologist were called in and they were not able to find anything either. He did complain of chest pains, but it was determined that it might be heart burn. They did see a sign of Afib, but test were not conclusive. On Friday, Feb. 12th he was sent home with antibiotics and heart medicines. The confusion has improved, but he is very weak and not mobile without assistance.

Swelling of face. Denies difficulty swallowing, shortness of breath, rash. BP 136/68, RR of 16, HR of 84. Benadryl 25mg PO given at 1625 and was observed for an additional 15 minutes. No worsening of symptoms and slight improvement. He is here with his daughter who is an RN and feels comfortable taking him home. No further treatment initiated.

Feb 9, patient was light-headed, as if he was going to faint. He did not have appetite. Evening of Feb 9, started vomiting large amounts of blood. Ambulance took him to hospital. CT scans showed abnormally enlarged pancreas. Patient aspirated blood and was put on a ventilator for 48 hrs. Endoscopic ultrasound showed ulcers in stomach that appear to have been bleeding, which were clipped and shot with epinephrine. After being treated for ulcers, patient developed blood clots in leg and lungs. It is almost two weeks since initial emergency, and patient is still showing sings of internal bleeding (low blood pressure, low hemoglobin, blood in stool). Still no firm explanation for continued bleeding. Before adverse event on Feb 9, patient did not report other symptoms from shot, however, he did show unusual signs of large bruising on his arm. Patient is currently at Hospital. Blood thinners are being discontinued, but patient still has blood clots.

Resident rec'd COVID vaccine #2 on 02/02/2021 and was hospitalized on 02/03/2021. Diagnosed with UTI & Metabolic Encephalopathy. He was re-admitted to facility on 02/05/2021. On 02/08/2021 resident was found to be unresponsive with small amount of tan emesis in mouth and on bed. CPR initiated and resident was transferred to ER. ER MD notified facility that resident had died.

had trouble with his stomach in the bowels while sleeping; arm sore; This is a spontaneous report from a contactable consumer. An 85-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on 23Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that his arm was sore the first night (23Jan2021) and did not take anything for it. On Monday night (25Jan2021), he had trouble with stomach in bowels while sleeping. He wanted to know if this was an occurrence from the vaccine or if it was a random occurrence. In all things that he read, diarrhea like symptoms were not mentioned. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Patient stated he started having hives, diarrhea and chills 2 days after the vaccine. At the current time, 2 weeks later, he is still having the same adverse events and now has leg weakness.

Patient presented today to ED with palpations, nausea/vomiting, SOB, dry cough. Patient hypoxemic and admitted to the hospital. Patient currently still admitted. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.

85 year old male who presents with 2 episodes loose black stools, weakness, decreased appetite, increased lethargy and subjective fever today, 02/22. Again admitted and had further rheumatological and infectious work up with negative results He was initially admitted to Hospital on 02/12 with fatigue, atypical chest pain, melena. He had received 2nd dose of Pfizer vaccine on 02/10. He was hospitalized from 02/12-02/15 and thought to have viral pericarditis. Diagnosis at discharge: SIRS DUE TO NONINFECTIOUS PROCESS W ACUTE ORGAN DYSFUNCTION. He was started on celebrex in addition to the the colchicine as an anti-inflammatory. After initiation of the anti inflammatory medications, patient's fever resolved, he started feeling better and his inflammatory markers decreased. He was monitored for another days and was feeling better. He is therefore being discharged home. In view of the negative work up, there is suspicion that these may be a hyper inflammatory response to the COVID vaccine since his symptoms were temporally related.

Extreme exhaustion and weakness. Loss of appetite. Incontinence. Inability to participate in activities of daily living. Possible stroke. Amnesia. Delerium. Visited Dr on March 1st. Bloodwork taken. Bloodwork showed high white blood cell count. On 3/2/21, Doctor advised patient to go to ER but patient refused. Urine sample dropped off on 3/3/21. Urinalysis showed bacteria in urine. Doctor prescribed cephalexin for possible UTI and ordered brain MRI without contrast. Patient is still exhausted and sleeping a great deal. Appetite is improving. Additional information for Item 18: Patient cannot remember any events between February 24-March 9, 2021. MRI done on 3/12/21. Waiting on results of MRI. Switched primary care on 3/12/21.

Hallucinations (first time ever experienced), confusion, paranoia, loss of appetite loss of balance, dizziness, decline in ambulation ability. Dragging feet on ground, unable to use steps.

Patient reports that the morning after his 2nd vaccine on 2/26/21, he experienced severe lack of energy, with lightheadedness and N/V. He reports that symptoms lasted 2-3 days. He reported adverse reaction on 3/22/21 to his nurse

Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: CAREGIVER REPORTED PATIENT STOPPED EATING AND HAD FEVER OF 101, FEVER WENT DOWN AFTER A DAY OR SO BUT CONTINUED NOT TO EAT-Severe, Additional Details: CAREGIVER REPORTED PT HAD FEVER AND LOSS OF APPETITE AFTER FIRST DOSE, QUESTIONED IF SECOND DOSE IS APPRORPIATE. PER THE CDC GUIDELINES THE PATIENT DID NOT HAVE A SEVERE ALLRGIC REACTON TO THE VACCINE AND THEREFOR SHOULD PROCEED WITH SECOND DOSE. CAREGIVERS STATES TOOK A WHILE FOR PT TO REGAIN APPETITE AFTER THE FIRST DOSE. SECOND DOSE HE HAD FEVER OF 101 FOR ABOUT 1 DAY BUT LOST APPETITE AND NEVER REGAINED. PASSED AWAY ON THE 24TH OF MARCH. CAREGIVER STATES PT WAS \"STRIVING\" PRIOR TO 2ND DOSE

My father received his first Pfizer vaccine on 02/03/21. On 2/12/21 I rushed him to the ER. He was vomiting uncontrollably and had shortness of breath. Once arrived at ER, they immediately put him on oxygen. Vomiting lasted several hours. They tested him for Covid and did a chest x-ray. Tested positive for Covid. Chest x-ray showed Covid pneumonia. Was admitted. Stayed in hospital for 5 days and was then released to nursing home for physical and occupational therapy. He was very weak and on days experienced what they called Covid fog. After 2 weeks of therapy, he was released on 03/06/21 to go back home to his apartment, with extended visiting nurse therapy. On 3/10/21, was the first visiting nurse appointment. At 12:00 an RN came to his apartment from Home Health Care. She checked his vitals. She said his blood pressure was good, lungs sounded good and oxygen level was 98. She said he was doing good and that she would not need to continue to come out and check on him weekly. She left. At 2:30 the same day, a Physical Therapist from Home Health Care came. She asked him lots of questions and adjusted my fathers' walker for him. He showed her how he was doing using the walker. Walked approximately 15-20 feet in his apartment. She checked his vitals before she left. His oxygen level was now at 91. She had him take a few deep breathes until his oxygen level was up to 93. She left and said she would be back on Friday the 12th to begin the actual physical therapy then. Within 10 minutes after she left my father started shaking uncontrollably and was having difficulties breathing. I called 911. Paramedics arrived. My fathers' oxygen level was all the way down to 74. They took him to the ER. When getting him out of ambulance he began vomiting. Vomiting lasted for hours just like when he went to the hospital back in February. They tried 3 different drugs to control the nausea. They did EKG, chest and abdomen scans. Was found that he had multiple blood clots and inflammation in his lungs and a bacterial infection in his blood. After testing, bacteria was found to be E Coli. Treated him with heparin for clots and antibiotics for infection and had him on oxygen in nose. Every day thereafter, he felt worse. They switched him to a high flow oxygen mask to keep his oxygen levels up. By Saturday night (early morning Sunday) on 03/14, they had taken the high flow oxygen mask off and hooked him up to a BiPap oxygen machine because his oxygen levels were dropping too low. We were then told by the lung doctor, that the damage to his lungs was extreme and that the next step would be to put him on a ventilator and feeding tube. My father did not want this per his will and his discussion with Dr earlier in the week. Dr indicated that he would not get better just being on the BiPap machine and we then chose to have them take him off of the machine because he did not want to go on life support. My father passed away on Sunday, March 14th around 6:30pm.

Patient had chills the night after the vaccine and throughout the night pulse ox dropped to 88, given 3L O2. Pt had little sleep and the next day had no appetite pulse ox between 88-90. After dinner had severe chills, no fever ,extreme SOB , pulse ox down to 79, coughing up blood tinged sputum, fluid in lungs, anxious. EMT called sent to hospital confirmed to have had an MI and new onset CHF, enzymes elevated, creat 1.8. Transferred to hospital and was stable. The next day still SOB, enzymes lessening, trying to wean from O2. The nurse attempted to get the pt to the bathroom he became extremely SOB and became unresponsive. They attempted CPR and the pt expired shortly thereafter due to another MI.

after 3 days from the first injection diarrhea lasting 72 hours and resulting in 10 lbs weight loss after 2 days from the second shot same result ...took Imodium and it finally stopped

PMH of CAD, HTN, DM2, atrial fibrillation on Eliquis who was last seen normal at 2330. Family heard a thud in pt's bedroom and found him on the ground with left gaze. EMS called, placed pt on a C-collar and brought to ED as a stroke code activation. On presentation, pt with left gaze and right hemiparesis and LLE weakness. He was non-verbal and not following commands. Head CT showed no acute hemorrhage. CTA with perfusion did not show a large vessel occlusion or significant hypoperfusion. Clinical picture suspicious for ictal event so he admitted to the NSICU for further workup.

Patient came in for vaccine with his son. During the screening, the patient's son answered all of the questions regarding the patient. The patient's son denied any previous serious reactions to medications including the components to the vaccine. Only medical condition the patient's son mentioned was hypertension. The patient was vaccinated, and appeared fine. Once he got to the waiting area, he stated, "I feel hot." His coat was removed, the manager was notified,. We gave the patient something to drink, a snack, and a cold icepack. Once the patient's condition continued to decline, vital signs were assessed. Blood pressure was 140/110, pulse oximetry was 87% on room air, and patient was placed on oxygen. I notified the manager to go grab the doctor as I was helping the patient. The doctor brought a glucometer to make sure the patient was not hypoglycemic, and the result was 117 mg/dL. At this point the patient was diaphoretic, and complaining of pain in his abdomen. He also complained of nausea. The squad was alerted, and came to get the patient. At this point the patient's pulse ox was 53% on 6L of oxygen. Patient's family was present with the patient, and the patient was then transported to the hospital via EMS.

Severe abdominal pain . He has had CT's, bone scans, and lab work to diagnose a cause and there's no answer. He is still battling this pain and is homebound taking narcotics to full the pain.

This 85 year old white male received the vaccine on 2/19/21 and went to the ED on 4/05 and was admitted with generalized weakness, hyponatremia, fever and elevated bilirubin. On 04/16/21, he went to the ED and was admitted to the hospital on 4/17 with poor appetite and hospital admission dx of ketonuria, leukocytosis, renal insufficiency, elevated troponin, hematuria, generalized weakness and died on 4/19/2021. 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.

Admit 5/23. Vaccine 1/16, 2/10. H/O CAD, CHF, previous strokes. Presented to ED from NH with AMS, fever. COVID+. CXR shows no infiltrates. No supplemental O2. Also found to have acuta CVA. Palliative care consulted, family agreed to hospice. DC'd to Hospice.

Fever, discomfort, restlessness. Administered Tylenol at Dr's instruction; He collapsed and died. He first reported nausea occurring around 4 am on 2/25/21 and was uncomfortable all day. He felt worse that evening and was showing a fever. He was given Tylenol around 10 pm on 2/25/21. He fell asleep around 2:00 am on 2/26/21 and woke up around 3:00 or 3:15. He had a drink of water then collapsed. I performed chest compressions until the EMTs arrived but he was likely dead by the time they arrived.

having difficulty breath; too much stress for the heart; Having problems swallowing was reported as worsened; He is not able to eat or drink; swelling; She stated patient's weight has fluctuated; Fluid retention/ Fluid retention and high level of CO2 in blood system; CO2 was high/ Elevated CO2 levels and unable to arouse; This is a spontaneous report from a contactable consumer (patient's daughter). A 85-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single (at the age of 85-years-old) for COVID-19 immunization; tafamidis (VYNDAMAX, 61mg once daily by mouth), via an unspecified route of administration from an unspecified date for amyloidosis. Medical history included amyloidosis, sleep apnea which was diagnosed before he was taking either Vyndamax or Vyndaqel. There were no concomitant medications. Previously patient received first dose of BNT162B2 as 1st dose, single (at the age of 85-years-old) for COVID-19 immunization. Patient was on Vyndaqel 4 times a day and had some diarrhea. He was switched to Vyndamax about 3 months ago and in the last month, he started to have problems with swallowing. He was hospitalized and had to be intubated because he was having difficulty breath and his CO2 was high and the doctors thought it was too much stress for the heart, so they intubated him. While in the hospital, a feeding tube was put in because he could not pass the swallow test and they gave him one Vyndamax through the feeding tube but no more. He has been in the hospital twice and since then, has had difficulty swallowing food and pills. She has read on social media that other people on Vyndamax have had difficulty swallowing. The swallowing issues also started after having received his second dose of Pfizer's covid vaccine. Maybe about a month and a half ago, he started having problems swallowing and realizing it was possibly a side effect from it. He was having problem with the pills. He is currently in the hospital. He ended up where they had to intubate him and now extubate him. He is not able to eat or drink. Because of him being intubated, they were not able to continue giving him the medication. He has not taken it for 7-8 days. If the swelling is partly from being intubated, she is guessing that was part of the problem before, once they have been off the medication for a while, if that occurred with the swelling, would that go down after a while. She stated patient's weight has fluctuated. This occurred during the whole time, off and on. He was on Vyndaqel before this and does not know how long. It has been over a month that he has been having issues swallowing. He actually came home from the first hospitalization on 05Jun2021 and was only home for a day and a half before they had to take him back. He was again experiencing effects of CO2 where he was sleeping and they could not wake him up. On an unspecified date in May2021, the patient experienced having difficulty breath, too much stress for the heart, fluid retention/ fluid retention and high level of co2 in blood system, having problems swallowing was reported as worsened, have problems with swallowing, on 07Jun2021, the patient experienced co2 was high/ elevated co2 levels and unable to arouse, on an unspecified date in 2021, the patient experienced he is not able to eat or drink, swelling, she stated patient's weight has fluctuated. The patient was hospitalized for all events. Reporter seriousness for Having problems swallowing was reported as worsened, reporter seriousness for Fluid retention and high level of CO2 in blood system was hospitalization from 22May2021 to 05Jun2021, reporter seriousness for Elevated CO2 levels and unable to arouse was Hospitalization from 07Jun2021 to Ongoing. The patient underwent lab tests which included CO2 with high, swallow test which was not pass. Patient received treatment for having difficulty breath, co2 was high/ elevated co2 levels and unable to arouse, too much stress for the heart, having problems swallowing was reported as worsened, have problems with swallowing. The outcome of events (having difficulty breath, CO2 was high/ Elevated CO2 levels and unable to arouse, too much stress for the heart, Fluid retention/ Fluid retention and high level of CO2 in blood system, He is not able to eat or drink, swelling, She stated patient's weight has fluctuated) was unknown, the outcome of events (Having problems swallowing was reported as worsened, have problems with swallowing) was not recovered. Information about lot/batch number has been requested.

Patient presents to ED with 2-3 weeks of weakness, fatigue, anorexia. No known Covid exposures. Cough, productive at times. CT scan shows extensive lung infiltrate consistent with COVID per note.

right hand swelling, right knee swelling, right ankle swelling, facial swelling of left cheek Narrative: Following 1st COVID-19 vaccine dose on 12/17/20, patient seen at Emergency Department on 12/21/20- 12/22/20 for eval of new left cheek swelling and right hand/ankle swelling. Hand x-ray did not show signs of fracture, head CT did not show any signs of new strokes, and labs showed mild BNP elevation. Per ED note, "Based on the patient history, physical, and initial vital signs - the patient's initial presentation is concerning for heart failure/volume overload->pulmonary edema and bilateral pedal edema." He received ipratropium neb x1 and returned to facility. Neurology consulted (12/22/20), "It is difficult to determine whether the patient has a new facial palsy or whether this is recrudescence of his previous stroke deficits. Given the swelling of his left face it is quite possible that there is inflammation causing some partial left facial nerve dysfunction that would not include the forehead. The pattern of weakness is, however, also consistent with what would be expected from his documented right MCA stroke. At this point it is appropriate to consider this a possible complication of his vaccination (Bell's palsy has been reported in some after Covid19 vaccination). However, I would not recommend any specific treatment for the facial weakness as the etiology is still somewhat unclear." Patient admitted to hospital 1/2/21-1/8/21 for mild hypothermia with possible AMS and found to have adenovirus. Head CT negative for CVA. Sepsis/toxic/metabolic w/u was unrevealing. Given IVF for diarrhea; C diff negative. Discharged to facility. Patient received 2nd COVID-19 pfizer vaccine on 1/13/21 in Right Deltoid w/o complications (lot#: EK9231, exp. 04/30/2021)

Pt on 6th day post vaccine and is having swollen glands hard to eat and drink that is more painful on one side; Diarrhea; Body aches; Chills.

chronic case of diarrhea- the loose stool had a strong chemical stench; chronic case of diarrhea- the loose stool had a strong chemical stench; I did about 7 bowel movements all night until next morning; This is a spontaneous report from a contactable consumer (reported for himself). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: E19262; expiry date: not known), via an unspecified route of administration in the right arm on 23Jan2021 13:30 at single dose for COVID-19 immunization. Medical history included 2 heart surgeries- 1 triple and 1 double. Concomitant medications included lisinopril, metoprolol, and tamsulosin. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 24Jan2021 01:00 (reported as 'Sunday evening past midnight'; pending clarification), the patient had to get up and run to the bathroom with a chronic case of diarrhea- the loose stool had a strong chemical stench. He did about 7 bowel movements all night until next morning. The patient asked if it was a reaction to the COVID-19 (vaccination). The reported events were assessed as non-serious. The outcome of the events was recovering.

Received Pfizer Covid Vaccine in the AM on 2/9/21. Arrived to emergency department later the same day complaining of nausea, weakness, fatigue, Vomiting, Diarrhea. Post operative diagnosis, Ischemic colon/toxic megacolon.

The day after the 2nd shot, patient developed blisters on his lips and mouth. The care facility said that he had a nut allergy -- but he had never been allergic to nuts. He stopped eating and drinking and his BP had dropped to 60/40. By Jan 16th they called to say he was dying and he passed away on 1/18/21. Patient had COVID19 from Oct 29th - early November. By Nov 21st he had lost 40 lbs. He was 6'3" and had gone from 189lbs to 149 lbs with COVID. By Nov 21st when we could visit, he had recovered from COVID, but was very thin and weak. He could not bathroom alone and kept falling. He didn't seem to have a bad reaction to the 1st COVID shot, But he immediately reacted to the 2nd shot and passed away within 6 days.

hard on hearing/lost his hearing; pain in his right ear; Chills; headache; Fever; Weakness; lacking appetite; This is a spontaneous report from a contactable consumer (patient's wife). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9810, expiration date was not reported) (at 86 years of age), via an unspecified route of administration in the left arm on 03Feb2021 15:00 at a single dose for COVID-19 immunization. Medical history included ongoing chronic lymphocytic leukaemia, ongoing blood pressure abnormal and ongoing thyroid disorder. Concomitant medication included hydrochlorothiazide which he was taking for years, ibrutinib which he was taking for 7 years, levothyroxine which he was taking for 10 years and losartan which he was taking for 8 years. The patient had no any other vaccine prior to covid vaccine. It was reported that the patient received the Pfizer covid vaccine on 03Feb2021. 24 hours later (04Feb2021), he experienced pain in the ears, headache, chills, and fever up to 101.5 for almost a week now, and currently is hard on hearing and had been feeling weak and lacking appetite. It was added that a week ago he received the first dose of the Pfizer COVID 19 vaccine on 03Feb2021 at 1500PM in the left arm. Within 24 hours the side effects started. He had a pain in his right ear and a headache. Since then he has gradually lost his hearing in that ear and they are following up with an ear nose and throat doctor. On 04Feb2021, he got a fever of 101.5, chills, weakness and no appetite. Since then in the evening he had been having kind of a fever of 100 to 100.5 and she has treated with TYLENOL. The fever comes and goes. In the morning he was normal. Adds his appetite was better but he still has to force himself to eat. She queried if should the patient get the second dose of the vaccine. Patient is scheduled to receive the second dose on 04Mar2021. The patient did not visit the ER. The patient underwent lab tests and procedures which included body temperature: up to 101.5, fever of 100 to 100.5, and 101.5 on 04Feb2021. The outcome of the event loss of hearing, fever, weakness, and pain in his right ear was not recovered; headache and chills are recovered on 05Feb2021; while recovering for lacking appetite. The loss of hearing was reported as worsened. Therapeutic measures were taken as a result of fever (pyrexia).

Pt admitted to Hospital on 2/8/21 with 2-3 days of SOA and cough. His wife was diagnosed with COVID-19 at approximately the same time when the patient received 1st COVID-19 vaccine. Pt had not felt well since receiving the vaccine and had some changes in taste or smell. He became acutely worse 2-3 days p/t admission with DOE, productive cough, H/A, N/V, profound weakness and bilateral infiltrates on CXR. He was hypoxic on room air. During hospitalization, has gone back and forth from BiPAP to HFNC. Unable to prone. Pt and wife discussed goals of care and decided on comfort measure approach. Pt expired on 2/19/21.

Nausea Dizziness Had slight seizure (lasted approximately 5 seconds- arms up and shaking, eyes closed, fell back in chair) Cold sweats (still nauseous 3 1/2 hours after injection, unable to keep anything down (including water)

Patient was found sitting in his driveway around 4pm, dizzy with incontinent stool and vomiting. He was brought to ED where he was found to have skull fracture and SAH. Patient was admitted to the hospital . Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine. This hospitalization does not appear to be related to the vaccine.

/o fatigue, weakness around 1330. Beginning at 1700, caller c/o stomach cramps, diarrhea & nausea. Today, c/o intermittent mild cramps. Denies any other symptoms. Advised to increase fluids if possible, continue to take normal medications as prescibed. Follow up with PCP if you symptoms get worse, or UC/ER for severe symptoms

2/27/21 hpi86 y.o. male with a past medical history notable for Dementia, hypertension, hyperlipidemia, recent skin breakdown. The patient presents for evaluation of worsening issues of cellulitis and acute renal failure skilled care facility. Due to patient's dementia other history could not be taking. Patient has had decreased intake. Patient has had some worsening issues with skin breakdown. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient does show signs of discomfort with his bottom. Patient otherwise appears to be at baseline. Hospital Course: patient was admitted to the hospital for worsening dehydration and finding UTI and pneumonia. The patient is also found have skin breakdown. The patient was placed and patient is started on IV fluids and IV antibiotics and wound care was started on patient. Patient did have some issues with behaviors but this was improved with treatment. 3/20/21 readmission acute renal failure

The background is he was hospitalized for 5 days in November 2020 for coronavirus, admitted with fever, chill, weakness, and inability to walk. Discharged with 3 weeks physical therapy to regain his strength. First vaccine on 2/4/2021 and within 24 hours experienced similar symptoms, profound weakness and fever. Second vaccine on 2/25/2021 and within 12 hours he was unable to walk, with weakness, fever, and confusion. He was taken by ambulance to the hospital on 2/26/2021. I did question his internist and the person at HealthCare facility on whether or not to proceed given prior reactions. During this admission determined to have heart attack with cardiac cath and stent placement. Brain MRI showed new 1cm occipital left infarct and developing pneumonia. Started on anticoagulation with Plavix and ASA 81mg. Readmitted to the hospital on 3/8/2021 with suspected GI bleed. Had colonoscopy and endoscopy with gastric erosion cauterized.

Violent onset of chills, fever, diarrhea, gradually better over a week, back to normal after weeks, fever for one day of 100.4.

blood pressure went much too high; blood glucose went high also; After the first shot, I experienced very bad GI problems. Did not associate this with the vaccine at the time. Received the second shot on 2/27/21 and condition worsened. Not only did I experience ter; This is a spontaneous report from a contactable consumer (patient). This 86-year-old male patient receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (Lot: EL3247) on 27Jan2021 06:30 PM at single dose on Left arm, second dose on 27FEB2021 at single dose on Left arm, both for COVID-19 immunization. Medical history included Diabetes mellitus. The patient was not diagnosed with COVID-19 prior to vaccination. Allergies to medications, food, or other products was no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications the patient received within 2 weeks of vaccination. After the first shot, the patient experienced very bad GI problems. Did not associate this with the vaccine at the time. Received the second shot on 27FEB2021 and condition worsened. Not only did patient experience terrible GI problems, his blood pressure went much too high and blood glucose went high also. The events onset date was reported as 28JAN2021. The adverse event "GI problems" result in doctor or other healthcare professional office/clinic visit. There was treatment received for the adverse event, medications to lower blood pressure and blood glucose. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was Recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

shortness of breath, generalized weakness, loss of taste and smell, nauseated, diarrhea or abdominal pain supplemental oxygen per hypoxia along with IV remdesivir and IV dexamethasone, Tessalon for the cough

My nervous system is a wreck; Have not slept in two days; My digestive system is unfix, I have gone to bathroom like 3 times yesterday; I feel like I wanted to throw up; discomfort; This is the spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (Pfizer vaccine; Lot number: unknown; Expiry date: Unknown), via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history included unspecified Diabetes. Concomitant medications included Losartan (unspecified dose) and Xarelto 20 mg. On 26Jan2021, patient experienced my nervous system is a wreck (nervous system disorder), I have not slept in two days (insomnia), my digestive system is unfix , I have gone to bathroom like 3 times yesterday(gastrointestinal disorder), I feel like I wanted to throw up (nausea), discomfort (discomfort) and I can't you know (incomplete sentence) and the patient was just trying to find out, how long this side effect would last approximately or what to do, to ease my discomfort. Therapeutic measures taken as a result of the events; Tylenol and patient regular medications were taken. The outcome of the events were not recovered. No follow up attempts are possible. No further information is expected. 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.

On 3/20 this patient started exhibiting right sided facial droop and paralysis of right arm and leg, dysphagia. On 3/25 he was discharged from the hospital on hospice.

COVID-19 Body aches Runny nose Diarrhea, unspecified type Cough Close exposure to COVID-19 virus Fever, unspecified fever cause

The patient received his first dose of Pfizer COVID vaccine 6/9/21 at pharmacy. He was then admitted 6/20/21 at hospital with abdominal pain, sepsis and a suspected aspiration event and expired on 6/23/21. This was felt by the treating physicians to be most likely not related to or associated with the vaccine, but given the close proximity it was asked that this be reported.

vomiting and diarrhea and lack of energy, poor eating; vomiting and diarrhea and lack of energy, poor eating; vomiting and diarrhea and lack of energy, poor eating; vomiting and diarrhea and lack of energy, poor eating; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a 86-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL9264), dose 2 via an unspecified route of administration, administered in Arm Right on 05Feb2021 14:30 as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included pacemaker (Caller says this was put in about 5 years ago this coming May); Blood pressure high (Caller says this was diagnosed about 35 years ago); high cholesterol (Caller says this was diagnosed about 35 years ago) and diabetes (Caller says that he had a little sugar, but everything is under control with medication. She clarifies that at one point they said he had diabetes and his A1 sugar or A1C when it was last taken was 7.1). There were no concomitant medications. Patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL9261), first dose via an unknown route of administration on 15Jan2021 (Batch/Lot number : EL3247) as 1ST DOSE, SINGLE for covid-19 immunisation. On 06Feb2021, the patient experienced vomiting and diarrhea and lack of energy, poor eating. The patient received treatment for diarrhoea. It was reported that Caller was calling on behalf of her 86 year old male friend. Had the second dose of the Pfizer COVID 19 vaccine on Friday, 5Feb2021. On Saturday her friend had vomiting and diarrhoea and lack of energy, poor eating. Sunday vomiting had stopped but diarrhoea continues. Took Imodium today. It was reported that consumer clarified to be the Pfizer COVID-19 vaccine, second dose. She says that he had the same shots at the same time she had them but he has had severe reactions to his. She says that they got their second dose on Friday February 5th and the next morning he had severe vomiting and diarrhoea and no energy at all. She says on Saturday the 6th he had vomiting and diarrhoea, bit on Sunday the 7th he did not vomit at all. She says he still has diarrhoea yesterday and today and he was not totally listless but he had no energy. Caller says she has been feeding him rye bread with peanut butter on it and yesterday she fed him some toast with egg on it and then a bit later vegetable soup with crackers, then later he had some popcorn. Caller says she also started him on Imodium, which he started taking today on 8Feb. Caller says she was having trouble reading the Imodium label, it was not printed. UPC: Not provided. LOT: SHF081, EXP: May2022. She says that he took his first dose so far only which was two 2mg capsules by mouth. At the time of reporting, the outcome of the events were unknown. Follow-up attempts are completed. No further information is expected.

he keeps throwing up and it's just mucus; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A contactable consumer (patient's daughter) reported for her father that an 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 10Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient's daughter said her father has been vaccinated today 10Jan2021 for the 1st dose, and he kept throwing up and it's just mucus since an unspecified date in Jan2020. Outcome of the event was unknown. Information on Lot/Batch has been requested.

- vomiting multiple times 2-3 hours after the vaccine - severe headache 2-3 hours after the vaccine- given tylenol - severe dizziness 2-3 hours after the vaccine - fainting 2-3 hours after the vaccine - extremely tired

Delirious; He woke up sick on stomach and throwing up; He woke up sick on stomach and throwing up; This is a spontaneous report from a contactable consumer (son). An 87-year-old male patient received BNT162B2 (lot number: EK9231, expiration date: 30Apr2021) first dose on 15Jan2021 around lunch time at single dose for COVID-19 immunization. Medical history included high sugar and COPD (Chronic obstructive pulmonary disease). Concomitant medications included gabapentin, metformin, ferrous sulfate, acetylsalicylic acid (ASPIRIN 81). Patient took the vaccine 15Jan2021 around lunch time and this morning (16Jan2021) he woke up sick on stomach and throwing up and kind of 'deluce' or delirious. Consumer just started giving patient fluids and Pepto Bismol as treatment. The outcome of the events was unknown.

Resident developed fever, aches and diarrhea on the evening of 2/7/21. Tylenol administered for fever and pain. Imodium administered for diarrhea. As of the afternoon of 2/8/21 the resident is without any further symptoms.

fainted; nauseated; vomited 4 times; dizzy; bad headache; extremely tired; This is a spontaneous report from a contactable consumer. An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Right arm (at age of 87-year-old) on 21Jan2021 at 12:00 PM as a single dose for COVID-19 immunisation, lot number: EL3247. Medical history was none. Patient had no allergies to medications, food, or other products. Concomitant medications within 2 weeks of vaccination included ibuprofen (ADVIL) and melatonin (minimal usage). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. It was reported that on 21Jan2021 at 02:45 PM (also reported as 2 1/2 hours after vaccine) patient became nauseated, he vomited four times, was dizzy, fainted, had bad headache and was extremely tired. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient was treated for the events with nausea medications and ibuprofen (ADVIL). Since the vaccination patient had not been tested for COVID-19. Patient recovered with lasting effects from the events.

Patient presented to ED with reports of weakness stating that he was lightheaded and felt like he was going to pass out. Also stated that he had nausea. Patient lowered himself to the ground and called his son to help and take him to the hospital. Stated that he frequently has dizziness in the mornings (for the past 5 years) and that they have increasing in frequency. On arrival to the ED, he continued to have generalized weakness and was unable to sit up.

Pt presented to the ED after a syncopal episode at home. Pt was on the toilet having a bowel movement when he developed sudden-onset nausea, light-headedness, and dizziness. He felt that he was going to pass out and his daughter came into the room and helped him. He did not lose consciousness or hit his head. Symptoms resolved "several minutes later." Pt complains of new-onset heartburn. Pt states that the symptoms he felt during the episode were similar to the sensation he felt during a heart attack he had several years ago.

[COVID-19 Vaccine] treatment under Emergency Use Authorization(EUA): He presented 10 days after first COVID-19 Vaccine with Progressive neurological deficits with bulbar manifestations - dysarthria, dysphagia and bilateral arm weakness and incoordiantion, worse on right. MRI brain was negative for acute stroke and MRI cervical, showed degenerative changes. Transferred from community hospital to tertiary center where the diagnosis was made of AIDP. He was intubated at that time in Neuro ICU. Given Steroids and IVIG but no improvement and was either will need to have Trach and PEG vs CMP and family honored the patient's wishes and made him CMO. signs of severe demyelination and AIDP was diagnosed.

Unable to stand or walk; Unable to stand or walk; Pulmonary edema weakness; Temp. 101.7; Vomiting; weakness; This is a spontaneous report received from a contactable consumer (daughter of the patient) reported for in response to HCP follow-up letter sent in cross reference case. A 87-year-old male patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, second dose on 03feb2021 (formulation: Solution for injection, lot number: EIV6202) via intramuscular route of administration at single dose for covid 19 immunisation. The patient's medical history and concomitant medications was not reported. Historical vaccine of BNT162B2 for COVID Immunity on 06Jan2021. On 04Feb2021, the patient was unable to stand or walk. It was reported that the patient had to call all could not get off couch, no strength in his legs. All came could not stand or walk. On an unspecified date, patient had temp. 101.7, vomiting, SOB, chest X-ray showed pulmonary edema weakness. The patient received IV Lasix, one dose IV Antibiotics, physical therapy consult. On 05Feb2021 he could stand again on his own and able to walk on 06Feb2021. Discharged home on 07Feb2021. The outcome of event pulmonary edema was unknown and rest of the events was recovered on 11Feb2021. The reporter assessed the events are related to drug.

an 87 year old male with ESRD on PD, pAfib, CAD, HTN, HLD, hypothyroidism, who was brought in after a witness cardiac arrest. Patient apparently received the first dose of the Covid vaccine (pfizer) at around 11 am. He was doing fine the rest of the day until later in the evening when he had shortness of breath without chest pain, abdominal pain, nausea, vomiting. Upon EMS arrival, the patient appeared to have some agonal breathing and then went down, was in PEA arrest, received CPR with 1 dose of calcium, 1 dose of bicarbonate, and 3 doses of epinephrine with return of spontaneous circulation. Upon arrival in the ED, patient had an intraosseous line, on dopamine for soft blood pressure. Patient has been successfully intubated.

The patient was admitted to the hospital on 4/25 c/o fatigue, hypoglycemia, and poor oral intake. He also complained of shortness of breath, which was an indication for a COVID-19 test. The specimen was collected and came back positive on 4/25. After a day at the hospital, the patient developed increased shortness of breath, had 80% oxygen saturation on a non-rebreather mask with subsequent upgrade to BiPap, and was using accessory muscles of respiration. His CXR on 4/25 on admission showed patchy b/l infiltrates. CT confirmed findings of CXR and was found to have ground glass opacities. The patient's ABG showed hypoxemia. On the morning of 4/27, the patient was found to be severely hypoxic and was electively intubated. As this form is being filled out, the patient is in the ICU on a ventilator due to COVID-19 pneumonia.

This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route on left arm single dose for COVID-19 immunisation on 22Feb2021, 02:00 PM, at 87-year-old. No medical history and concomitant medications were not reported. No other vaccine in four weeks and no other medications in two weeks. On 22Mar2021, 03:30 PM, the patient had lost consciousness 10 hours, could not walk, fever 101, extreme dizziness, vomiting, had to crawl when vomiting. No treatment. Outcome of the event was resolved on unknown date. Information about lot/batch number has been requested.

Contact w and exposure to oth viral communicable diseases (Primary Dx); Infection due to 2019-nCoV ED to Hosp-Admission Discharged 3/23/2021 - 3/29/2021 (6 days) INPATIENT DISCHARGE SUMMARY Admission diagnosis: Primary Admission Diagnosis Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Yes Hospital Course Patient is a 87 y.o. male with a past medical history of coronary artery disease, chronic systolic heart failure, hypertension, hyperlipidemia, type 2 diabetes mellitus who was admitted to Hospital with COVID-19 pneumonia. Hospital Course: COVID-19 pneumonia. The patient was treated with convalescent plasma and IV remdesivir and completed the course. He was treated initially with IV Decadron which has been transitioned to oral tablets for discharge to complete a 10-day course. Chronic systolic heart failure. Coronary artery disease. Orthostatic hypotension in the setting of chronic hypertension. The patient does have chronic systolic heart failure with an EF around 20% and is followed closely at the heart failure clinic. He is chronically prescribed Lasix at 80 mg twice daily, however he did have some episodes of orthostatic hypotension during his hospitalization and has been unable to tolerate other guideline directed medical therapy due to his hypotension. He is euvolemic at this time. I have decreased his Lasix dosing to 40 mg twice daily to restart tomorrow morning. His last dose of the 80 mg of Lasix was yesterday morning. I do feel that in the setting of COVID-19 pneumonia and decreased oral intake that he is more at risk for continued hypotension and dehydration aggressive diuresis. He will remain on aspirin, Plavix, and simvastatin. Type 2 diabetes mellitus. His last hemoglobin A1c showed good control at 6.3 on 3/3/2021. His glipizide was held while inpatient. He was on long-acting Lantus insulin 10 units with stable blood sugars in the hospital. He was also on correctional lispro insulin. His glipizide will be resumed upon discharge.

pt became very nauseated after vaccine. Pt also stated he did not eat today prior to vaccine. Pt BS checked and VS WNL. Watched by physician and monitored for 20 minutes then felt better.

My Dad received dose 2 of the vaccine on 3/22/21. On 3/29/21, he woke up to extreme shortness of breath and excessive bowel movements. Both are still continuing to date. He has been to his infectious disease doctor, his cardiologist, and to his nephrologist. Shortness of breath continues. He has also developed edema in his legs. His heart condition worsened suddenly after the vaccine. He will be having a heart procedure on 6/1/21 to address one of the issues. At this point, there has been no improvement 10 weeks post vaccine. As I type this report, I am sitting next to him as he helps me with the information and I can hear his breathing which is very labored.

diarrhea; Borborygmi; This is a spontaneous report from a contactable physician. This 87-year-old male physician reported for himself that an 87-year-old male patient received first dose of BNT162B2 (solution for injection, lot number: EL3302, Expiration Date: Unknown), via an unspecified route of administration on 08Jan2021 in his left arm at about 2:00PM at single dose for COVID-19 immunization. The Patient Medical history included Hypertension, GERD. Concomitant medications were not included. that the patient received second dose of BNT162B2 (solution for injection, lot number: EL9263, Expiration Date: Unknown), via an unspecified route of administration on 29Jan2021 in his left arm in his left arm at about 12:30PM. at single dose for COVID-19 immunization. On Jan2021 Borborygmi (clarified as belly gurgling) and he also experienced diarrhea. He said it is annoying to hear his belly gurgling. He said the Borborygmi and diarrhea started 10 days after his first COVID-19 Vaccine shot. The Patient reported he had a phone call with his doctor on Monday, 01Feb2021, due to snow, and his doctor put him on probiotics. He said he was getting better with taking the probiotic. The outcome of the event was resolving. Relatedness of drug to reactions was reported as related for diarrhea and Borborygmi. Follow-up attempts are completed. No further information is expected.

Had 2nd vaccine on 3/13/21 and developed flu-like symptoms the following day. Symptoms include fatigue, body aches, no appetite, and lasted 3 days.

Hospice Resident received first Covid 19 vaccine dose on 1/6/21. 1/7/21 resident had decreased appetite noted in am but ate 100% of meal at dinner. 1/9/21 resident had decreased appetite with emesis x 2, loose BM x 2. Call placed to hospice. 1/10/21 5:44 am resident able to take HS meds, ingest 2 cups of shake. No emesis or loose stool noted. 12PM nurse noted resident not eating meals but ingesting milkshake and medications without any problems. Hospice contacted for change in condition. 1:00 pm hospice ordered Phenergan 12.5 mg Q 6 hrs PRN. Labs to be drawn 1/11/21. Hospice notified POA. 1/11/21 12:24am Resident had blood in stool. Resident denies any pain, on 2L of O2 for comfort.

Vomit 30 minutes after administration. approx. 9 hours later, resident has Stroke-like symptoms. He was previously on Hospice before admitting to our facility and planned to be readmitted to hospice upon discharge.

diarrhea; This is a spontaneous report from a non-contactable consumer reporting for himself. An 88-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing rhinorrhoea, ongoing lacrimation increased, tooth loss and ongoing viral infection. Concomitant medication included plantago ovata (METAMUCIL). The patient experienced diarrhea on 16Jan2021 with outcome of unknown. No therapeutic measures were taken as a result of the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

There were no side affects after the first vaccine Lot# EK5730. Following the second vaccine on 1/28/21 I started feeling fatigued that evening but felt better the next morning. The following day on the 29th around 7pm I started feeling severe nausea at first and then had severe vommiting so I called 911, they took my vitals and said they were in a safe range, I did not go to the hospital and then today around 7a.m. I started feeling better and the nausea stopped.

Terrible pain in back of neck/ very bad pains back of my neck; Shoulder pain; Headache comes and goes; Little nauseous; Feeling generally unwell; Short of breath; Muscle pain; This is a spontaneous report from a contactable consumer (patient). An 88-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot number: EL3249; expiry date: unknown) via an unspecified route of administration, on 14Jan2021, at a single dose, for COVID-19 immunisation (to protect from the virus). Medical history included COVID-19 and he was in the hospital for 3 or 4 days. He came out 10 days later and it was negative. Other medical history included heart disorder. Concomitant medications included carvedilol (COREG) taken for many years because it strengthens his heart, apixaban (ELIQUIS) as blood thinner, finasteride, furosemide (LASIX), sotalol, spironolactone, and ezetimibe, simvastatin (VYTORIN). The patient received his first vaccination this past Thursday and everything was fine. He woke up the following morning (15Jan2021) with terrible/ very bad pains pain in back of his neck, shoulder and headache. He was a little nauseous, just feeling generally unwell, and short of breath. The headache comes and goes which he controlled with Tylenol. He also had muscle pain on an unspecified date in Jan2021. Tylenol was also taken for events muscle pain, shoulder pain, headache, and terrible pain in back of neck/ very bad pains back of my neck. He was wondering if there is anything, he should know and do about it. Patient underwent an unspecified blood test/ lab works with unknown results. Outcome of the events headache and short of breath was recovering, for event muscle pain was unknown, while for the remaining events was not recovered.

Pt. tested positive for SARS-CoV-2 on 2/3/2021 and required hospitalization for associated diarrhea and dehydration with mild acute kidney injury. Of note, he has not been hypoxic and has not required supplemental oxygen to maintain his SaO2 as of 2/6/2021.

chills; stomach problems/ stomach pains; back problems; weakness/low energy; sore arm for a couple of days; aching; upset stomach; lost weights; nasal drip; feeling "miserable"; he was really not well; diarrhea; sick/artificial sickness; This is a spontaneous report from a Pfizer-sponsored program. An 88-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER9231), via an unspecified route of administration on left arm on 08Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure high, diabetic and chronic obstructive pulmonary disease (COPD), he had started no new medications and not had any other recent vaccinations. He took a lot of medications for a lot of things. He was diabetic, had high blood pressure, COPD, a variety of things get over the years, he took medication for these things. He was affected by medications more than most people. No further details provided about his medications. He reacted to medications in general and that because of that he usually took lower dosages. The patient's concomitant medications were not reported. After 2 weeks from the vaccine. Have weakness and stomach pains and diarrhea. The patient had been artificially sick like 4-5 days since 21Jan2021, and had a test done and it didn't show up. He said he hadn't been anywhere to get the virus. He said he didn't have any fever, his oxygen level hadn't changed, he had a testing kit with thermometers, so he knew he never had a fever, but he got chills. He got all the symptoms, the stomach problems, diarrhea, back problems, overall weakness and low energy. He was fine two weeks before this, this started almost two weeks to the day and minute from when he went and got the shot. When he got the shot he had nothing, he waited 15-20 minutes with no problems, his arm was hurting for a couple days, but there was nothing else. Two weeks later he got basically an artificial case and the corona virus test said no, clarified to being negative, but he said it didn't go away, it had been from Thursday to Monday, so 5 days. The big problem was he was supposed to get his second shot Friday, and he had an appointment Wednesday, he would like to ask them too, but he would like to know was it dangerous for him to get the second shot. He didn't think he can get any sicker. He did not do a report online, he tried to get onto the website but nothing told him how to do it or whatever, so he stayed on the line waiting to talk to someone. Height: he was five feet and nine and three quarters inches tall, he had shrunk with age, everyone got smaller. His arm was not sore for very much, he didn't remember how long, he got sick two weeks later, and now he was really not well, though he was better than he was on Thursday or Friday, though he was not 100% yet. He would like to know if he should get the second shot, because he was too old to die from a corona virus shot. Investigations: He didn't know which COVID test they used, they did an instant test with results in an hour. The patient inquiry if he should get the second shot since he had had this artificial sickness for 5-7 days, two weeks after getting the vaccine. He had "sore arm for a couple of days" after the 1st injection, but "nothing more". However, in the last 4-5 days, he's been feeling "miserable". He didn't have fever. But he's been experiencing aching, diarrhea, upset stomach, lost weights and nasal drip. He tested negative to the COVID virus. He has a doctor's appointment scheduled this Wednesday. The outcome of events was unknown.

Throwing up foamy stuff; Oxygen saturation was in the 80%s; confused; This is a spontaneous report from a contactable nurse. An 88-year-old male patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3302), intramuscular at the right arm on 25Jan2021 02:30 at a single dose for COVID-19 immunization. The vaccine was administered in a Nursing Home. No other vaccine was given to the patient in four weeks. Medical history included Parkinsons, dementia, diastolic heart failure and known allergies: Iodine, Propranolol. Concomitant medication included paracetamol (TYLENOL), melatonin, quetiapine fumarate (SEROQUEL), ropinirole and sertraline hydrochloride (ZOLOFT). On 26Jan2021 11:30 AM, the patient was throwing up foamy stuff and his oxygen saturation was in the 80%s and was confused. The events led to Emergency room/department or urgent care visit. Treatment was given for the events. The patient has no COVID-19 prior to vaccination. He was tested for COVID-19 on 26Jan2021 with Nasal Swab, Rapid Test and the result was negative. The outcome of the events was unknown.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

While being monitored after receiving second dose of COVID 19 vaccine, patient developed fatigue and was noted to have a blood pressure of 76/41. No other physical complaints. Wife noted patient had decreased oral intake recently but otherwise denies any recent illness or positive sick contact. Was brought to the ED and given 500ml of normal saline IV.

My Brother has been vomiting since 2/16/21 He is in Hospital since2/20/21 He is on IVs and antiemetic medicine but still vomiting

Bleeding out of ileostomy; Did not sleep; no appetite; Feeling unwell; achy; tired; weaker; This is a spontaneous report from a contactable consumer (patient's daughter). An 88-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283), intramuscular on 30Jan2021 09:45 at SINGLE DOSE in left arm for Prevention. Medical history included Type 2 diabetes diagnosed 10 years ago, Quadruple Bypass surgery in 2003, High blood pressure. He was Diabetic, was a heart patient. Before he had his ostomy, he had colitis that causes the patient to bleed when pooping and his guts were ravaged. His stomach might be weakened from having it for years and years in his 30's, 40's to early 50's. Family medical history included Grandfather died at 42 of bleeding ulcer in his stomach. There were no concomitant medications. Prior Vaccinations within 4 weeks was none. He has allergies to pills but was not taking any. He does not have a fever. She has the names of the pills he is allergic to as follows: Simvastatin, Lisinopril, Losartan, Aggrenox cap. They are listed on his report from (institution name withheld) that he has allergies to. He received his first dose of the Pfizer COVID-19 vaccine on 30Jan2021. There was no prescriber on 30Jan2021 through 01Feb2021, everything was good. On 02Feb2021, that is when his ostomy shot out blood like a faucet when he was taking a shower. He was changing the bandage that day, he was changing his right sided ileostomy bag and he told her that blood shot out of it "like a faucet." On 3Feb2021 was nerve wracking, but there was no blood. He was changing his ostomy pad again on 04Feb2021 and it started bleeding so much that he went to the hospital. He was discharged within a few hours because "they couldn't find anything wrong." He has had colitis for years and has an ileostomy, where they take out a bunch of his colon. This week he has had some funny bleeding in his ileostomy. It was spurting out blood. He had to go to the ER on 4Feb2021 night because it was bleeding and then it stops. People in ER did not know what the bleeding was from. He was bleeding in the ileostomy on 04Feb2021 and 05Feb2021. On 05Feb2021 his ostomy bled a little bit more but it has not bled again since 06Feb2021. She also reports that he feels, " icky, tired, no appetite and achy." The feeling unwell began on 7Feb2021. That worsened since loss of blood made him weaker and worried. When he got back from the hospital/ER, he said they were rude. There was a blizzard. He checked in around 8pm and they discharged him around 11pm that same night. ER visit at the institution on 04Feb2021, 8pm to 11pm and released. They performed CT scan abdomen and Pelvis and IV. Results are unknown. Now he was good. The achiness and tiredness was between persistent and worsened. He was worrying now. She took his forehead temperature and it was good on 7Feb2021. She took everybody's and they were all good. He just feels icky and the blood thing is nerve wracking. He is convinced it is coming back. He was not on a blood thinner or anything listed on the vaccine fact sheet. The patient experienced Feeling unwell on 6Feb2021 with outcome of Not Recovered (Feeling unwell was reported as worsened), achy and tired on 5Feb2021 with outcome of unknown, No appetite on 7Feb202108:30 with outcome of Not Recovered, Bleeding out of ileostomy on 2Feb2021 09:45 with outcome of Recovering, Did not sleep on 7Feb2021 21:30 with outcome of Not Recovered. He has a lot of the risk factors; He is Diabetic, is a heart patient, and has high blood pressure, but he really wanted to get the shot. The patient's primary care provider's nurse do not believe the bleeding had anything to do with the Pfizer COVID-19 vaccine.

Patient became profoundly weak, lethargic, depressed and anorexic. He lives in a retirement community in an apartment alone He became unable to care for himself and was transferred to Skilled Nursing Facility which was onsight. He had a positive PCR test at time of admission on 2/9/2021. He had no respiratory symptoms or hypoxemia. He had 12 lb weight loss. He remained in skilled nursing until 2/25/2021. He looked moribund initially. He was severely depressed, dehydrated and was refusing to eat. He gradually came back to his normal, vibrant self after 13 days.

Severe fatigue, lethargy observed by family members on date of discharge from sub-acute nursing care to home 02/03/2021 and subsequently on 02/04/21 with complaint of shortness of breath. Continued lethargy and shortness of breath on 02/05/21, 02/06/21. Lethargy, shortness of breath and loss of appetite, chills, on 02/07/21. Less lethargic on 02/08/2021 but worsened shortness of breath and loss of appetite. Patient requested 911 call on afternoon of 02/09/2021 for shortness of breath. Rapid Covid screen at ER was positive and staff reported beginning treatment with dexamethasone and remdesivir. Hospital staff reported to family that patient had pneumonia, congestive heart failure, confusion on 02/10/2021. Nursing staff reported patient was getting antivirals and antibiotics. Patient was transported for care by pulmonary specialist at Hospital on 02/13/2021.

Mass confusion , lack of appetite, unsteadiness, extreme fatigue and malaise. This started exactly 1 week after his shot and has improved some but still lingers up to this date. We don't know if there was permanent damage.

Extreme confusion, words were unintelligible Dry heaves Could barely walk Doing odd things...trying to drink out of tissue box Sucking on blanket table & walker Could not understand directions Slept then awake every 20 min No fever

Patient vaccinated with first dose of Pfizer with subsequent infection and hospitalization due to COVID-19 infection. Initial H&P reads in part as, "Patients symptoms began on or around Thursday 3/11 when he began to feel fatigued. After two days of fatigue, he presented to an urgent care facility on Saturday 3/13. He was noted to have a fever there and was diagnosed with a presumed UTI, though patient reports at bedside that he has not had any dysuria. He was treated with nitrofurantoin and increased his furosemide temporarily per urgent care's recommendations. He then presented to the ER on 3/15 with continued fatigue and a low blood pressure at home. We were unable to clarify the method by which the blood pressure measurement was obtained and/or if it was repeated. Antibiotics were changed to cephalexin at that time despite a relatively clear UA. His daughter brought him back to the ER today (3/18) due to persistent issues with low grade fevers in the 100-100.5 range, significantly worsening fatigue, anorexia, and oxygen levels of 92-93% on nonproductive cough. Does not have a home O2 requirement. In addition, he endorses feeling chilled during the admission evaluation. Denies any chest pain, nausea, vomiting, fevers, diarrhea, constipation. # Fever Progression of symptoms from Saturday 3/13 may constitute original presentation of Covid-19. Presentations on 3/13 and 3/15 with dyspnea and fatigue. Initially thought to be UTI and was treated with nitrofurantoin and cephalexin. UA on 3/15 in ED was negative for leuk esterase and nitrites. Tested positive for covid-19 on 3/18 with lymphopenia, 90-92% on room air. No home O2 req. Given duration of symptoms and worsening fatigue and fevers, will admit for treatment of Covid- 19. Also considered CHF exacerbation, COPD exacerbation as explanations for dyspnea. Possible CHF exacerbation as well given 1+ bilateral pitting edema to mid-shin and JVD to ear lobe. Suspicion for COPD is low given no report of increased sputum production and questionable history in chart to begin with. Would be beneficial to clarify history with collateral history 3/19."

Patient was a 88 yo M who presented to hospital on 2/19/2021 with acute onset unsteadiness and trouble swallowing. The patient noted that these symptoms began on day of admission and receiving his vaccine 7 days ago in which he noticed he had increased malaise and increasing DOE/SOB. Patient was noted to be hypoxic with SpO2 in 80s increasing to 90s on 2L NC and in atrial fibrillation on admission. Patient tested positive for COVID-19 on admission and was placed on dexamethasone 6 mg daily for 4 days, ceftriaxone 2g qd for 4 days, and doxycycline bid 100mg for 4 days. Patient improved over the 6 day stay until he was stable on room air at rest and upon ambulation at which time he was discharged home on 2/25/2021.

My Father had been in his usual state of health when he received his first Pfizer Covid-19 shot on 1/12/2021 and his second dose on 2/2/2021. He complained of being tired and chills on 1/13/2021 and again on 1/20/2021. He was diagnosed with a UTI and placed on antibiotics on 1/27/2021. After the second covid-19 shot on 2/2/2021 my father had a change in his condition on 2/4/2021. He became very lethargic, more confused and unable to speak and was send to the Hospital. He spent from 2/4/2021 to 2/12/2021 in the hospital being treated for a UTI and also was said to have had a Transient Ischemic Attack. He went to a rehab facility for Physical Therapy from 2/12/2021 to 2/19/2021 after which he returned to the Assisted Living Facility. He had another episode of lethargy/unresponsiveness on 2/26/2021 and was once again sent to the hospital where they did not show any new findings. He spent a few days in the hospital before returning to his facility where he continued to have periodic episodes of increased lethargy/confusion and decreased eating. He was placed on Hospice and passed away on March 29th.

4/14/2021 at ~8am, Patient was out of bed and in his wheelchair and consumed 100% of his breakfast. During lunch time, he only consumed 25% of his meal. At ~2pm, patient was noted to be unresponsive. Oxygen saturation was 88% and B/P was low and oxygen was administered and Oxygen Saturation increased to 92%. The patient was placed in bed and Dr and the family were notified. The resident was continuously monitored by the Hospice nurse, who happened to be on-site and the primary nurse. At ~6:30pm it was noted that patient was having labored breathing so 0.25 ml of Morphine Sulfate Solution 20mg/ml was administered with releif. At 8:30pm, patient expired.

ED to Hosp-Admission Discharged 4/28/2021 - 5/1/2021 (3 days) Last attending ? Treatment team Acute respiratory failure with hypoxia Principal problem Hospital Course Admission HPI: (patient) is an 88 y.o. male come to emergency room for evaluation of cough with thick yellow sputum which is going on since past 2 days. Which is progressively getting worse. Associated with some shortness of breath. On arrival of EMS patient found to have significant hypoxia with 70% at room air. He was placed on nasal cannula. Did bring him to the emergency room. Patient had a dose of Covid vaccine and is due for second dose soon. In emergency room, he was thoroughly evaluated. He found to be septic. He was given dose of IV Levaquin and Covid swab come back positive. Hospitalist service requested to admit the patient. Asking patient, is feeling little better after coming to emergency room. He is having shortness of breath with significant cough with sputum production. He felt wheezy. Denies any fever but had chills. He feels nauseated. Hospital Course: Pt was admitted to the hospital for management of acute hypoxic respiratory failure secondary to COVID-19 virus pneumonia. His breathing improved precipitously. He had resistant hypertension this admission and was started on amlodipine. He did have mild hyponatremia this admission but did not appear to have any volume overload. TSH elevated at 13.8. Will need repeat study. He did also have rising procalcitonin and received few doses of antibiotics. Lipid panel was benign. ED Discharged 5/9/2021 (58 minutes) Hospital ER Treatment team Thrush, oral Clinical impression Sore Throat Chief complaint ED Provider Notes (Physician Assistant) Emergency Medicine Cosigned by: (Doctor) at 5/9/2021 6:45 PM Attestation signed by (Doctor) at 5/9/2021 6:45 PM The patient was seen and treated primarily by the PA-C. I did not independently evaluate the patient. Chief Complaint Patient presents with ? Sore Throat HPI Patient is a very pleasant 88-year-old male with recent COVID-19 infection diagnosed on 4/28/2021 on oxygen 4L NC, who presents to the emergency department complaining of sore throat x 1 day. He states that he started yesterday with a sore throat, painful to swallow, then noticed this morning that he had twice patches on his tongue and mouth. He states he is able to tolerate food and liquid, but that it hurts to do so. He denies any fevers or chills. From a Covid perspective, he states that he would not be here if it were not for the pains and sores in his mouth/throat. He feels that his breathing is stable and he is doing well on 4 L of oxygen nasal cannula as prescribed. He has finished a course of Decadron and states he is currently on no further treatment for COVID-19. ED to Hosp-Admission Discharged 5/10/2021 - 5/13/2021 (3 days) Hospital (Doctor) Last attending ? Treatment team Aspiration pneumonia Principal problem Hospital Course Patient come to the hospital with complaining of abdominal pain and hypoxia and cough. Patient found to have a right middle lobe pneumonia. We are believing that it is aspiration pneumonia which is improving at this time. He had a recent COVID-19 infection which is resolving at this time. During course, GI, pulmonology, urology and oncology consultation obtained. Patient continued to improve clinically. Patient had a urinary retention because of the constipation. He is able to void now. Today morning, I am seeing him. He is feeling better. Is agreed to go home. I discussed with the patient's wife regarding plan. Once he fully recovered from pneumonia he need to have colonoscopy and possible biopsy of colon mass.

Per discharge summary, patient presented to BHL with his wife with increased shortness of breath, diarrhea and hematuria. Found to be COVID +. Patient tested positive for COVID 5/21. He has received both Pfizer vaccinations. Patient was admitted and started on treatment for Covid with remdesivir and steroids. He was continued on his home dialysis schedule. He continued to have intermittent confusion and then for the last 3 to 5 days was very confused and more unresponsive. Reviewed goals of care with wife at length and palliative care was consulted. Decision was made not to pursue feeding tube due to patient having clearly outlined his wishes and his advanced directive. Upon further discussion with family hospice was consulted and patient was transitioned to inpatient hospice

Pfizer COVID 19 Vaccine EUA Pfizer Dose 1 2/18/21 (EN6200) Pfizer Dose 2 3/12/21 (EN6208) COVID Positive 5/13/21 5/20/21: The patient presents with fever and stats that he started couging 12 days ago. He was seen in the ER on 05/13 for fever and cough. He was was found to have covid. Blood test were unremarkable and the chest X ray was negative. He was enrolled to the Covid out patient risk assessment. He states that he continue to have fever with eakness. He was seen 2 days ago at the clinic. He was sent home but he continue to have fevr, cough and weakness. No shortness of breath. No chest and no abdominal pain. No nausea nor vomiting.. The onset was 12 days ago. The course/duration of symptoms is constant. Associated symptoms: cough, decreased oral intake, denies chest pain, denies shortness of breath, denies rhinorrhea, denies sore throat, denies nausea, denies vomiting, denies abdominal pain and denies rash. Temperature is 102 Fahrenheit. 6/2/21: Patient continues to feel well; nurse reports he is cleaning is dinner plate thoroughly; he has questions about discharge; physical therapy was unable to assess him yesterday, they will see him this morning at 9:00 a.m.; if they recommend physical therapy we will proceed in that direction; if they state that he is at his baseline and not in need of their services, we will discharge him with monitoring. 6/3/21: Discharged home.

Several hours after vaccine patient had nausea, vomiting (green mucous), chills, diarrhea and confusion. Patient is in generally good health so confusion was concerning. Patient was taken to the hospital via ambulance. Do not know outcome.

VOMITING AND DIARRHEA. VISISTED ER ON 1/29/21. CAME BACK TO ASSISTED LIVING FACILITY, THEN WENT BACK OUT TO HOSPITAL AND WAS ADMITTED ON 1/31/21

2/14/2021 Resp panel: COVID19 + Started on 2/14/21 Dexamethasone 6 mg po daily and on 2/15/21 Remdesivir 200 mg IV x1 dose then 100 mg IV daily x 4 doses. 89-year-old male presents to the emergency room with epigastric abdominal pain and shortness of breath and was found to have acute pancreatitis and COVID-19 pneumonia.

Patient admitted to the hospital testing COVID positive and with a GI bleed (has a hx. of chronic duodenal ulcers and was on an anticoagulant)

Right dorsal medullary stroke leading to dysphagia and left-sided sensation changes. First noticed symptoms on 2/25 but did not present to emergency room until 2/27/2021. Patient was hospitalized 2/27/2021; anticipate discharge 3/4 or 3/5 2021. Patient lost ability to swallow; requires tube feeding.

2/17/21 Pt w/fever, SOB and diarrhea. Positive household exposure to COVID. + for SARS-CoV-2. Was given fluids and no hypoxemia. Discharged to home and set up with monoclonal AB infusion 2/18/21 In am pt received bamlanivumab w/o issue 2/18/21 several hours later pt returned to ED w/fever to 103.1, tachypnea and hypoxemia. Pt was started on steroid and he had rapid improvement. He weaned off oxygen on 2/19. He was discharged 2/20.

Chief Complaint Arrived via EMS- per wife pt has been more confused than BL, febrile, incont of bowel and bladder. Denied pain. +cough, SOA. Got first dose of COVID shot wed.. A&Ox1. Has left sided weakness from prior CVA History of Present Illness 89-year-old male who presents to the ER via EMS with confusion. He has also reportedly had a cough and some fever. There has been some report of incontinence of both bowel and bladder. He received his first dose of the Pfizer Covid vaccine on Wednesday, 3/17. He and his wife have returned to the home after wintering in another state. According to his wife, with whom I have spoken this evening, last night he suddenly became confused. The confusion continued throughout the day today, thus prompting the EMS called to the house and the subsequent journey to the ED for further evaluation. In the ER this evening, a battery of testing was completed. A Covid swab is indeed positive. His wife is uncertain of any positive contacts. He had some vascular congestion on chest x-ray. He has a prior history of pleural effusion which is thought to be resolved. He does have a history of lower extremity edema. He had some urinary incontinence and his wife held his Lasix Saturday morning. He was noted to be slightly hypoxic around 88% on room air. He was around 85% or so on room air at home with their home pulse oximeter device. He has been placed on 2 L of nasal cannula.

Per wife, husband is unable to eat, weakness, fatigue, spasms Recommended to see primary provider, was told by wife that hospice nurse will be notified

HE HAD A RECTAL BLEED AND WAS ON ELIQUIS, SO THEY STOPPED ELIQUIS, THEY SAID THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE

89 yo M presents with complaints of weakness and diarrhea for the last 3 days. He received his COVID-19 Vaccine about 10 days before presenting to hospital. Also complains of decreased appetite and oral intake, but denies any nausea or vomiting. Denies fever, chills, cough, and SOB. Patient tested positive for COVID-19 and was admitted on 01/27/2021 for dehydration, AKI, and pneumonia likely secondary to COVID-19 virus, although he did not exhibit any symptoms of SOB or cough. Patient was treated with IV fluids, Pulmicort, Decadron, Protonix, aspirin, and SQ heparin secondary to renal function. Dehydration and AKI were corrected and the patient was discharged on 01/30/2021 with no complaints of COVID symptoms and an

States that his symptoms are like he had a stroke; his health declined after the shot; not eating; he is not able to walk by himself; Can't stand up on his own; Mind is not working correctly/The patient was not himself/his mind goes in and out; Speech is Difficult/he was not responding to her and his speech was bad; not feeling very well/not feeling good; Tired and Sleepy; Tired and Sleepy; Noticed patient was warm but didn't take temperature; The patient didn't receive the second shot because he has been in the hospital.; This is a spontaneous report from a contactable consumer (patient's wife). An 89-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 04Mar2021 14:15 (Lot Number: EN6198) at the age of 89 years, as single dose for covid-19 immunisation. Medical history included pituitary gland tumour from 2018 and ongoing (it is not growing according to tests), ongoing asthma which he had for years, and ongoing low blood pressure. His blood pressure goes up and down. He has had it for a long time but started this medication 2 years ago because it was too low. Clarified that it was not taken within 2 weeks of receiving the vaccine because his blood pressure had been too high. There were no concomitant medications. The patient previously took fludrocortisone 0.1 mg once a day. The consumer (patient's wife) stated that she called on behalf of her husband. The patient was still in the hospital. The patient received the vaccine on 04Mar2021 and by 11Mar2021, the patient was in the hospital. They have not been able to find out what was wrong with him. The patient's symptoms were like he had a stroke. The patient was 89 years old, so she took him to get the shot and his health declined after the shot and he is still under the care of the (Hospital name) in (City) (State). The reporter clarified that his symptoms were that he was feeling tired and sleepy on 08Mar2021. The patient said he was not feeling good on 08Mar2021. On 11Mar2021, he was not responding to her and his speech was bad, and now he is not able to walk by himself and can't stand up on his own. This started after he received the shot. The patient didn't receive the second shot because he has been in the hospital. He was doing fine before and now he has these issues. The patient's wife (reporter) noticed the patient was a little warm but didn't take his temperature on 08Mar2021. The reporter stated that last Thursday (11Mar2021) they called the doctor and the doctor suggested taking him to the ER at the hospital. On 11Mar2021, the patient was not himself and not eating and she doesn't know what is going on with him, but he is under care at the hospital. Reporter stated the patient is doing therapy in the hospital and they are helping him to walk but he is having difficulty. She stated they keep asking if she knows what is going on, but she has no results or medical records. Reporter stated the patient's mind is not working correctly and speech was difficult for him. She clarified that he wasn't making sense sometimes and she was not able to understand him. States the patient speaks two languages but he started speaking a third language to her. She stated that his mind goes in and out. Treatment: rest and at the hospital they are doing therapy for his legs. States she will get on update on his progress on Friday. States she can't see him because of Covid restrictions. The patient did not receive any vaccines 4 weeks prior to COVID vaccine. Outcome of the events was unknown.

The patient presented to the Emergency Department with cough for 3 days, nausea, vomiting, fatigue, decreased appetite, and chest congestion. Upon admission on 03/25/21, the patient tested positive for COVID-19. The patient received levofloxacin followed by ceftriaxone/azithromycin, dexamethasone, remdesivir, and convalescent plasma.

89 y/o male, PMHx of hypothyroidism, HTN, dementia, admitted for weakness and 3 days of diarrhea on 1/28/21. Pt tested positive for Covid on 1/27/21 but was not found to be hypoxic. Pt was found to be clinically dry on exam, metabolic acidosis. Received fluids throughout evening. Symptoms resolved. Pt was discharged on 1/30/21.