Pfizer

01/06/2021 - 08:08 Complaining of fullness in the midepigastric area. Upset stomach. Dizzy. Nauseated. Temperature is 98.1, pulse 56, respirations 19, oxygen saturation 93% on room air and blood pressure 133/73. HGB 8.8.

Actual event and cause of death were unknown; This is a spontaneous report from a non-contactable consumer. A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID Prevention. The relevant medical history included aortic valve replacement from Nov2019. Concomitant medications were not reported. The consumer stated that she was taking the reporting responsibilities to report that a friend of hers, informed that the patient passed away on Friday, and had received the COVID vaccine on Wednesday. The consumer stated that it was unknown to her at this time, if the friend had called to complete a report herself, regarding the incident. Their conversation was very brief. The patient was 90 years old, and it was her friend's mother that was the patient. Actual event and cause of death were unknown. The patient had her vaccine on Wednesday 06Jan2021, and then the patient collapsed in front of the reporter at Friday night on 08Jan2021 and passed away that same day. The autopsy was unknown. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Actual event and cause of death were unknown

Ringing in ears and pain in both sides of neck. Pt alert, oriented, ambulatory, no weakness, no slurred speech

Patient is a 90-year-old female. She is a nursing home resident with and ongoing COVID 19 outbreak occurring . She has been diagnosed with corona virus on 1/4/21. She apparently has not eaten or drank anything in about a week. She was being hydrated at the nursing home with normal saline, but has failed to improve. She was sent to the ER and was admitted on 1/8/21 to hospital At no time during the hospital stay has she been more than minimal responsive. She need O2 for Comfort but on CXR and CT cardiopulmonary imagining was clear. Discharge note stated that he was requiring supplemental oxygen, but her chest x-ray on admission actually showed no acute cardiopulmonary disease. She was diagnosed with COVID-19 on 1/4/21. Most likely, this disease set her level of function back to the point that she was no longer eating and drinking, and she just overall rapidly declined after that. There was no evidence of an actual COVID pneumonia or pneumonitis. On 1/12/2021 family made patient a DNR and IVF were stopped and switched to comforted care. Patient expired 1/13/21

Patient experienced jaw pain with high blood pressure (200/72) within 15 minutes of receiving vaccine administration. History of aortic dissection.

Patient noted to have a change in status at 11:23PM that night. Her oxygen saturation had dropped from normal on room air to 82% and required oxygen. She was also noted to be lethargic with altered mental status and not responding verbally. She then began to mottle. Her oxygen saturation worsened to 51% on 4Liters of oxygen by the next day and she expired on 1/14/21.

Systemic: Other- pt had history of copd and DNR on file. approx 3 1/2hr after vaccine pt had sob and lowo2 sat, emergency services called, pt passed on their arrival.staff felt due to pt existing condition

Chest pain; shortness of breath and difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on the left arm on 11Jan2021 at single dose for COVID-19 immunization. Medical history included atrial fibrillation from an unknown date (AFib, diagnosed around 10 years ago), pulmonary issues from an unknown date and unknown if ongoing (pulmonary issues started within the last year), bad heart from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced chest pain, shortness of breath and difficulty breathing on an unspecified date. The patient further reported that she has a lot of the symptoms that she lives with daily, she has a bad heart, has A Fib, has a pulmonary doctor and she discussed this with her doctor and they told her to go ahead and get the vaccination, so she went ahead with the vaccine, about 3-4 days later, got these chest pains, she has not had any chest pains connected to her Afib before, she also had shortness of breath and difficulty breathing 3-4 days after the vaccination, when she sat down and waited for this to pass, when it did pass, does not know if it was 5 min or 10 minutes, when that went away she felt very good. The patient also reported that she has not had any more chest pains since the first episode, she is still struggling with the difficulty breathing but unsure if this is just her body and prior conditions or due to the vaccine. Does not know what it was, thought maybe she had a heart attack, wants to know if she should go ahead and get the second vaccine. Does not want to get any of the side effects worse than what she had, states someone told her the second one hits you harder and wants to know if this is true. The patient did not recover from shortness of breath and difficulty breathing while the outcome of the rest of the events was unknown. Information on the batch number/lot number has been requested

Pt states she feels lightheaded. Vitals obtained. No other symptoms identified or reported. Pt states her blood pressure was a little low before leaving home, reading was 128/79, HR 68. Pt currently 140/82, HR 67, O2 Sat 96%, RR 18. Pt educated on symptoms of adverse reaction. Pt offered further treatment; however she refused and states she now feels fine. Son is with pt & will be driving her home.

Pfizer-BioNTech COVID- 19 Vaccine EUA Patient experienced change in speech and jerky movements on way home from COVID-19 vaccine. Presented to ED. Patient diagnosed with Acute CVA (cerebrovascular accident). Patient discharged on 1/31/2021.

at 11:50 pt c/o palpitations- O2 sat 100, HR 48-53, BP133/41. given gingerale and mask break w/ improvement. no lightheadedness or CP. palpitations intermittent. 12:05 vital signs unchanged. ER eval. Pt transported via stretcher for monitoring

Bleeding; seeping from lower leg; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration in the right arm, on 03Feb2021 10:30, at a single dose, for COVID-19 immunization. Medical history included breast cancer and chronic obstructive pulmonary disease (COPD). The patient has no known allergies. The patient has many unspecified concomitant medications. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in other facility. On 03Feb2021, at 11:00 A.M., the patient experienced bleeding/seeping from lower leg. The patient did not receive treatment for the events. Outcome of the events not recovered. Information about lot/batch number has been requested.

Patient was admitted and treated for severe PE and DVT, as well as hypoxia and paroxysmal SVT. Pt was discharged to inpatient rehab when stable

syncope followed by ER visit w/ many negative tests. persistent weakness, apathy and loss of appetite

Difficulty breathing; Low blood pressure; This is a spontaneous report from a contactable consumer (patient). This 90-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201) via an unspecified route of administration in the right arm on 25Feb2021 at single dose for COVID-19. Medical history included Known allergies: Sulfa drugs, Afib, Diabetes, Meniere disease. The patient had COVID prior vaccination. Concomitant medications included amlodipine, celecoxib (CELEB), metformin, pravastatin, warfarin. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318) in the left arm on 04Feb2021 12:00 PM for COVID-19. The patient experienced difficulty breathing, low blood pressure on 26Feb2021 02:30 AM. The patient was admitted to Hospital. Life support IV in neck to maintain blood pressure. Treatment including high flow oxygen, life support IV to maintain BP was received for events. AE resulted in: emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient had no COVID tested post vaccination. Outcome of the events was unknown.

Day After - severe headache, 2 days after headache continues, itchy scalp, day 3 rash visible at hair line headache continues, more confusion than normal, day 4 on site nurses check rash and think it is dermatitis, day 5 continues to get work nurse practitioner was to visit next day, day 6 NP thinks that she has UTI and sends her to hospital (2/11/21). Hospital determines - Rash is Shingles, UTI present, - MRSA is now present in shingles which is on right back of head and right neck and face. Next Sepsis is diagnosed. Since 2/11/21 patient was not conscious. 2/20/21 famiy is notified that she should be moved to Hospice. Moved to hospice on 2/20/21. The patient, my mother, died on 2/23/21 official cause of death is UTI.

Chief Complaint: CHF exacerbation, atrial fibrillation Source of History: Patient History The patient is a 90 y.o. female with a past medical history notable for CHF, atrial fibrillation, arthritis, reflux, hypertension. The patient presents for evaluation of Worsening issues of shortness of breath in addition to fluid overload and swelling. Patient was also having rapid heart rate. Patient was recently stopped on her Cardizem as they thought that this was causing worsening swelling. Patient was set up for an outpatient echocardiogram however had not Got that completed yet. Patient notes that since diuresis patient is feeling much better. Patient is unsure about changes of heart medications. Patient did have close follow-up with Cardiology. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. 3/12/21 remains admitted at Hospital - in patient

Shortness of breath, anxiety, BP 227/104 (pulse 69), O2 sat 98%. BP eventually went down (not listed in report).

Thrombocytopenia and Presence of Schistocytes Thrombocytopenia and anemia–CBC reports schistocytes although this was not quantified, worrisome for microangiopathic hemolytic anemia (MAHA), such as TTP– anemia and thrombocytopenia both improving, in this case it is a resolving etiology, such as adverse effect from vaccine - remained conservative - consider reporting as vaccine side efffect as the vaccine is the most likely cause due to temporal relationship - monitor Thrombocytopenia – etiology is unclear but there is possibility related to drugs or Covid-19 Pfizer Vaccine she received

Patient required hospitalization for COVID-19 Seen at an urgent care 2/24 for sore throat. Clinically dx'd w/strep and started on cefuroxime and prednisone Continued to decline with anorexia, dry cough , mild sore throat and weakness. Was taken to ED 2/27 and diagnosed with COVID pneumonia. Had mild hypoxemia requiring oxygen. She was admitted from 2/27-3/3. She was treated with 3 doses of IV dexamethasone and Remdesivir. Because of the length of time from second vaccination ID was consulted. They SARS-CoV-2 IgG testing. Pt was negative. Therefore the pt was treated with one unit of convalescent plasma on 3/1 for passive immunity. She was able to be weaned off oxygen on 3/1 and was discharged on 3/3 Additionally her SARS-CoV-2 nasal swab was sent to the health department for genetic sequencing

11:11 After vaccination patient started to feel headache pain that radiates down to her chest. Began feeling chest pressure that doesn't radiate anywhere else. Patient stated that pressure is 7/10 pain. At 11:20 patient stated that "Headache is now gone but chest pressure remains the same." Daughter is with patient, poor historian on history and medication. Patient does have history of having Covid in December 2020 with hospitalization. Patient had similar event while hospitalized when given "certain medication" and it caused chest pressure which prompted medical staff to stop. EMS was called to come assess patient's need for higher level of care. Upon arrival, patient stated that pressure still "remained the same". After further assessment and EKG, decision was made to take patient to Hospital Emergency Dept for further treatment. Daughter made aware of decision and left with patient.

Covid vaccine monitoring documentation. 90 yof patient presented to ED 3/4/21 at 1233 unresponsive via EMS due to cardiac arrest. BP documented 82/43 at 1233, pulse 49. Prior to arrival, patient had been in bathroom and had syncopal event. Patient lived with family. EMS began CPR and administered doses of Epi. Documentation also stated patient?s family member said patient received their 2nd covid vaccine 5 days prior and has not been okay since. After arrival to ED, patient was intubated, cardiac ultrasound showed no cardiac activity and no pericardial fluid. Patient received sodium bicarbonate and calcium chloride. Patient expired in the ED department at 03/04/2021 12:51. Per Death Summary Form clinical diagnosis cardiopulmonary arrest, clinical impression of cause of death or terminal events leading to death, possible myocardial infarction. Pfizer EL9265 on 1/30/21, Pfizer EL9266 on 2/20/21.

3/24 arm pain, 3/25 rt shoulder and back pain, Tylenol given, 3/25 body aches and tired, Tylenol given 3/25 visit with dr to discuss pain- urinalysis ordered, later Tylenol and biofreeze, temp of 101 noted. 3/26 urinalysis results returned- NNO---- later 3/26This nurse is called to resident's room. Resident noted to have emesis of all bile, pale and lethargic. Complaints of not feeling well. Temp: 102.0, tympanic. Call placed to MA help nurse to update. Await call back .3/30 to dr again, confusion and bp issuesMercy ER, admit to hospital dx of cholecystitis.

Patient presented to hospital 4/6/21 with rectal bleeding and subacute dysnpea on exertion/fatigue over the preceding several weeks and was found to have immune thrombocytopenic purpura (ITP) w/ platelet count of 1000. Anticoagulation was reversed (on warfarin at home for history of PE). Platelet count responded to steroids and TPO-agonists per typical ITP treatment. Incidentally, the patient was found to have H. pylori stool antigen + and commenced with quadruple therapy for this. Platelet counts continue to improve slowly w/ treatment.

Stroke. ER treatment. Hospitalization. Skilled Nursing Facility. Symptoms: Weakness/fell to the floor/terrible bruises entire left side of body/slurred speech/confusion. Treatment: TPA administered. Hospitalized for 10 days, followed by continuing stay in skilled nursing facility.

02/21/21- Resident has been refusing meds and meal with continued poor PO nutritional intake, and lethargic. She continue to have periods of medication refusal and continued poor PO intake. 3/8 She developed shingles to her R buttock and was started on Acyclovir cream x7 days. She continues to decline medically. Admitted to Hospice on 3/12, poor PO intake and weight loss. 3/23 Resident passed.

Resident have had multiple PNA tx with IM Rocephin and IV Zosyn, Difficulty in swallowing, Elevated HCV RNA, 02/15 PCR Quant, ER visit following weakness and involuntary UE movements/jerking. Elevated amonia levels controlled with use of Lactulose. 02/22/2021 RUE and RLE extensive DVT. Worsening pressure wound and development of arterial wounds. Admitted to Hospice on 03/31/2021. Resident deceased on 04/03/2021.

This 90 year old white female received the Pfizer Covid shot on 3/25/21 and went to the ED on 4/27/21 and was admitted on 4/27/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified

Tired. Slept for while after shot, then a few hrs later, Pressure in chest followed by a feeling that I must breathe deliberately for myself or I might not breathe automatically. Did deep breathing, watched and wondered when I should get help. Realized I could help myself and began using acupuncture and applied kinesiology points. After a time, breathing slowly retuned to normal. Very, very tired.Next 2 days, balance poor. Actually fell before I realized how woozy I was. Hit head on wall, but not knocked out. After balance recovered, still very tired after 10 days, but not as bad. Memory worse. Hoping all will improve.

It started with swelling, redness, and heat at injection site pretty soon after the injection on Friday 5/21. By Sunday, 5/23, patient had instability when standing and walking; her dementia had gotten worse; there was edema in her whole right arm; and she started having tremors. She was brought to Hospital by ambulance that afternoon and has since had decreased appetite and thirst; continuing swelling at injection site and in her whole right arm; terrible tremors; very low oxygen levels; and is almost comatose. The doctors there have said her kidney function has dropped to unacceptable levels and they are also monitoring her heart. She has been put on hospice care as of this time, 5/26.

Pt received both vaccines of Pfizer. Pt was admitted to the hospital on 6/15 for SOB/dyspnea. SOB contributed to CHF exacerbation. COVID was incidental. No COVID treatments so far during admission.

The first vaccine was administered on December 30, 2020 from a local pharmacy. She was diagnosed with COVID on January 3. She was in and out of ER for 3 days, when we finally took her home and got hospice care. On January 19, 2021 Dr's office told us that she could get the 2nd vaccine the next day. She received the 2nd vaccine on January 20, 2021 from a local pharmacy. On January 21 she became disoriented and was sleeping most of the time, by Friday, January 22, she could not walk and was incoherent most of the time. The evening of January 22, we presume she had a stroke, but was not officially diagnosed. Her oxygen level dropped to 42 and her blood pressure was 287/182 with seizures that lasted about 1 minute. She died on January 29, 2021.

RLE edema started on 6-30-2021. Extensive RLE deep vein thrombosis was diagnosed through the ER. Due to the extensive DVT, this has been growing for longer than the symptoms have shown.

Fine in Am. Started complaining of stomach pain in afternoon. Had dinner around 6 pm & threw up part of it along with clear mucus and all the water she drank. After that it was all clear mucus off & on through the night. Has had this episode before but only lasting a few minutes never this long! Tried to give water but kept coming back up. Meanwhile pain in stomach (pelvic area) was getting worse. Called 911 at 2 AM (see line 19). Sometime after 911 left, the clear mucus started coming at a faster rate. Had bowel movement around 6 AM but said no relief in stomach pain. Called at 8Am. Could not come til between 12-1 PM. Seemed weak and very tired so let sleep. Around 10-10:30 AM could not wake her up. Called 911 again. This time it was cardiac arrest and they could not revive her.

7:00PM fatigued, burning up fever 100., ibuprofen/tylenol dose; Sunday afternoon nausea, loss control of body, anxious, feeling of fainting, unable to move-paralyzed, pressed button for medical help, ambulance arrived, pt transported to ER -- 102. temp ambulance, RN at hosp temp 98., pt was shaky, 8:30PM erratic heartbeat per admitting doctor - pt admitted. Pt PCP/Cardiologist contacted, kept on heart monitor, pt discharged Monday afternoon. 1/14/21 chest pain, nausea, 102. fever. symptoms

kidneys weren't acting/kidney issues; not having the feeling to urinate; Light-headed; This is a spontaneous report from a contactable consumer (reported for herself). A 91-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3248; expiration date: not known), via an unspecified route of administration in the left arm on 07Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure and blood thinner. Concomitant medication included apixaban (ELIQUIS) for blood thinner. The patient is asking if there were any reports of adverse events with kidneys and the vaccine. She received the 1st shot last Thursday (07Jan2021) and told that yesterday (10Jan2021), she had an episode where kidneys weren't acting. She also mentioned that she is on a blood thinner, ELIQUIS. She is due to receive the 2nd shot on 28Jan2021. She said that she wouldn't want to receive the 2nd dose if this was related to her adverse reaction. The issue with the kidney started after on 10Jan2021, yesterday she was really having problems, she went to church then came home by that time she would have to go to the bathroom, but she did not go, she ended up cooking dinner which was 3 hours later, she was noticing that she was not urinating. She drank some Gatorade and that made it little better, she is wondering if it's a side effect. On 10Jan2021, when she noticed the kidney issues, she did not know for certain if it started before that, she didn't pay attention. Also, yesterday (10Jan2021), she got sick in which she had to grab the counter, she felt bad, she wasn't dizzy, but felt light-headed. The symptom of not having the feeling to urinate had improved a little today but she is concerned and wanted to know if this was a side effect. Her being light-headed only occurred on 10Jan2021, it was a onetime occurrence yesterday. However, she was also just sitting around, laying around, after that yesterday. The outcome of the event 'light-headed' was unknown; while outcome of other events was recovering.

presented to the ED 1/5/21 with syncope 1 hour after receiving COVID vaccine found to have acute hypoxic resp failure at rest. Per family patient's pulse ox low with exertion at baseline for the past couple of months, but she always recovers to above 90%. She was discharged home with home health with oxygen 1/19/21

Patient reports elevated blood glucose readings into the "200's," shortness of breath and fatigue within 24 hours of receiving the Pfizer COVID-19 vaccine.

Dizziness about 5 minutes after vaccination. BP 220/110, rechecked at 190/110. EMS called due to high BP. EMS came and examined pt, released her to home.

Resident experienced flash pulmonary edema at 2300 on 01/25/2021 with SOA, Overt coarse crackles to all lung fields, hypoxia on room air requiring 5LPM via NC, Hypertension (190/102). Resident was sent to Hospital where she was admitted for pulmonary edema.

Patient with severe dementia developed nausea, dizziness and diaphoresis; acute distress. No chest pain or dyspnea noted. 3:49 P 56, 144/78, PO2 99% 3:54 P 34 164/58, O2 99% Exam CVS- irregular rhythm, systolic ejection murmur Care taken over by EMS and transported to Hospital

Chest pain; Dehydration; Elevated troponin; Encephalopathy, metabolic; Hypernatremia; Troponin I above reference range; Uremia; Weak; Weakness

Had swelling in leg for a couple of days prior to the early morning of 1/31 where the knee and entire lower leg was swollen and painful and made it very painful to walk. After sending photo to primary care physician had mom evaluated for a blood clot. It was determined based on blood test, vascular ultrasound that right non occlusive (mid) Femoral vein DVT.

COVID vaccination clinic received Pfizer vaccination at 1015, started with shortness of breath and a different feeling in her chest at 1022. Removed mask, inspected oral airway, no swelling noted. Individual talking and answering questions. BP 138/68, pulse 78, respiratory rate 20, oxygen sat 96% RA. Benadryl 25 mg orally administered 1025. Remained at bedside, granddaughter also at bedside. 1031 verbalizes feeling better. 1033 pulse 61, Pulse Ox on room air 98%. verbalizing wanting to leave, go home. 1045 left with granddaughter.

She had the vaccine on Thursday and no visible side effects. On Saturday she was very weak and had to be lowered to the ground. She was drooling and staring vacantly and was not responding to questions. This lasted for a bit. I called the ambulance which took her to the hospital. They hydrated her and sent her home with no idea what caused it. The next day she was sitting on the toilet and passed out with her eyes closed. She started drooling. I again called the EMTs and they came. She had come to and they said she fainted and it was probably because she was having a bowel movement. This has not happened before or since these two episodes. I do not know if she should get the next shot.

Extreme difficulty breathing upon exertion, collapsed shortly after walking started, loss of conciousness, and death

Within 15-minutes of vaccination, the patient reported SOB and felt that they were having difficulty taking deep enough breaths. EMS evaluated patient on-site. Patient was hypertensive (182/89) with a FSBG of 85 mg/dL. 12-lead EKG was unremarkable with sinus bradycardia without ectopy. ETCO2 values are within normal limits with square waveform. EMS transported patient to hospital. On arrival, patient noted her condition was probably due to anxiety and left without seeing a physician.

After the second vaccine dose she reported not feeling well with unspecified symptoms for a few days. On February 18th, 2021 she visited her doctor with numbness in her hand. They thought it may be carpal tunnel and sent her home. The morning or March 18th , 2021 she had a severe stroke and was transferred to Hospital and then to other hospital. She was in the hospital until Tuesday March 23rd when she was transferred back to her home for hospice care. She died on March 26th, 2021.

1/26 /2021 - pt went to ER for chest pain 2/9/2021 - pt received Pfizer COVID vaccine 1st dose 2/17/2021 - cardiac arrest with death

Acute myocardial infarction, NSTEMI, Atrial flutter, extreme weakness inability to get out of bed, headache, dizziness , nausea/vomitting,

Pt received the vaccine around 1200 PM. Around 1400 pt lost consciousness and became unresponsive and hypotensive with systolic BP at 90 per EMS. Pt was unconscious and unresponsive for approximately 10-15 minutes. Pt regained consciousness spontaneously and her BP slowly returned to normal over the next 3 hours.

Blood sugar has gone up/Blood sugar started increasing; Burning in chest; Had trouble keeping head up; Nauseous; Pain between shoulder blades; Pain at injection site; Did not feel good; Heartburn; Bones hurt worse than usual; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269, Expiration Date: 31May2021) intramuscularly, administered in left arm on 12Feb2021 at 14:55 (at age of 91 years old) at a single dose for COVID-19 immunization. Medical history included type 2 diabetes (Diagnosed 15-16 years before this reporting), high blood pressure prior to that. She lost a lot of weight since she found out she was diabetic, which was prior to getting vaccine, around 15-16 years before this reporting. She lost 50 lbs in 15 years. It has been gradually. She gets Prolia shots and did not get one this month. She has scoliosis and osteoporosis and that was one of the things that happened. She had previously broken her shoulder blade and some ribs on her right side. She confirmed that she broke it over a year before this reporting. She has a yellow mark and a little reddish mark that looks like someone hit you. It is still there and it is a fading black and blue mark and does not hurt any more. She takes blood pressure medicine. She does not take diabetic medication. She did in the past, but it caused her ankles to swell and then she started controlling it with diet. She was right handed and had trouble trying to do things with her left hand. This started prior to the vaccine. Family medical history included: Family heart issues and diabetes. Heart disease and cancer in the family. There were no concomitant medications. The patient previously took Prolia for back problems. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261, Expiration Date: 31May2021) on 22Jan2021 at age of 91 years old at a single dose for COVID-19 immunization. She didn't have any problems after the first COVID-19 Vaccine. No additional Vaccines administered on same date of the Pfizer Suspect. The patient experienced blood sugar has gone up/blood sugar started increasing on 15Feb2021 at 08:00, pain at injection site on 12Feb2021 at 14:55, pain between shoulder blades on 12Feb2021 at 20:30 to 21:30, had trouble keeping head up on 13Feb2021 at 07:30, nauseous on 13Feb2021 at 07:30, burning in chest on 13Feb2021 at 08:30, did not feel good on 12Feb2021 at 08:30, heartburn on 12Feb2021 at 08:30, bones hurt worse than usual on 12Feb2021 at 07:30. She has stated her blood sugar has gone up since she's received the second dose of Pfizer's COVID vaccine on 12Feb2021. Blood sugar started increasing was reported as worsened. She was type 2 diabetic and does not take any medicine. She got second shot on 12Feb2021, and her sugar was 89, then she started not feeling good the day after. On 15Feb2021, she was checking it and it was 119. On 16Feb2021, it was 145. On 17Feb2021, it was 144, and 18Feb2021, it was 145. She had never had them this high. It does not mention it can do anything to your sugar. She does not know her height. Last she was measured was 4'6"-4'7". Her highest was 5 feet. This was prior to the vaccine. She said her weight was between 80-85 lbs. The second shot hurt when they gave it to her. About 6 hours later, it felt like she was hit by lightning between her shoulder blades. She had previously broken her shoulder blade and some ribs on her right side. That has been bothering her and it felt worse when she got the vaccine and she could hardly lift her head up. The pain went from her left shoulder blade to right shoulder blade and stopped right away and then it felt like a lightening thing. She had trouble keeping her head up. She still has trouble with shoulders and is putting heating pads on them. She felt nauseous off and on. Her bones usually hurt, but after the second injection they hurt worse. As long as she puts heat on them, it feels better. The second dose feel like it hit the bone. The first one did not feel that way. The outcome of the event "Blood sugar increased, Chest burning, Feeling abnormal, Heartburn, Bone pain" was not recovered, for events "Shoulder blade pain, Heaviness of head, Nauseous" was recovering, for event "Vaccination site pain" was unknown.

Patient developed chest pains shortly after vaccination. Aspirin was given and patient was transported to ER via EMS.

Pt reported dizziness after receiving COVID vaccine. RN responded - checked pt's vital signs. BP 220/110, SpO2 94%, HR 79. Pt reported she had not taken her BP medication. BP rechecked at 190/110. EMS called and responded, talked to patient, released her to home.

SYNCOPE, fall, head contusion FATIGUE DIARRHEA Pneumonia due to SARS-associated coronavirus Diverticulitis Hyponatremia Hypoxia Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (CMS/HCC)

Team alert called at 1227.Pt had second Pfizer Covid vaccine at 1155. C/O dizziness around 1215. Sitting in chair with son at her side in wheelchair. Waiting for daughter-in-law. A&OX3. Head down. Denies pain. Skin warm and dry to touch. Feet elevated. BP 76/44. O2 sat100%, P-60. No breakfast this morning. Denies diabetes. Apple juice 6oz provided and consumed. Declined water. Daughter-in-law arrived, reports BP never that low. Patient remains dizzy. Team Alert called. Daughter-in law took patient's son to restroom. 1230-BP-89/50, P-60, O2sat-100% on RA. Report given. Daughter-in-law and son returned, advised patient taken to Dr. department/office

My grandmother had transient very high blood pressure for a few days about three weeks after vaccination. She always has really low BP because her thyroid is a little low and she's always had very low bp like 110/80. But for a couple days her bp was 156/80 and gradually went back down. I'm reporting this, because my mother-in-law had the exact same bp and experience about three weeks after the second dose. While transient, I think if this represents a trend, they should monitor at least the elderly for bp spikes a few weeks after the shot, just to make sure they don't have a stroke. I'll report my mother-in-law's experience next, she's almost the same age.

Death SHORTNESS OF BREATH Hyponatremia Atrial fibrillation (CMS/HCC) Generalized weakness SIADH (syndrome of inappropriate ADH production) (CMS/HCC) Pleural effusion on right Syndrome of inappropriate secretion of antidiuretic hormone Sick sinus syndrome

Temperature on arrival was 97 degree 18 minutes after the vaccination it was 103.4/six days running a 100degree fever; my blood pressure went to 170/100; my oxygen dropped to 88%; vomiting; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient (non-pregnant) received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in right arm on 02Feb2021 09:45 AM (at the age of 91-year-old) as single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease/COPD, asthma, hypertension. The patient has no known allergies. Concomitant medications were not reported. Patient took unspecified other medications within two weeks of vaccination. No other vaccine in four weeks. Patient was not tested positive for Covid prior vaccination. On 22Feb2021 at 10:15 AM, the patient experienced vomiting, blood pressure went to 170/100 and oxygen dropped to 88%. She was in bed end of the care of her daughter for six days running a 100 degree fever. Temperature on arrival was 97 degree 18 minutes after the vaccination it was 103.4. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient was not tested positive for Covid post vaccination. No treatment was taken for events. Outcome of events was recovered in 2021. Information about lot/batch number has been requested.

Note from 3/25/2021: PMH of asthma, PVD, Diabetes Mellitus type 2, Diastolic CHF , Aflutter , hypothyroidism , and allergies, who presents to facility with after her home provider saw her and concerned for pneumonia and worsening respiratory status. Lab work-up showed elevated WBC of 20.61, low potassium 3.2 , and BNP of 764. Her troponin was also elevated 0.147. Chest CTA done showed atypical infectious process with consolidation at the left lung base and secondary to pulmonary mycobacterium avium complex infection in the bronchiectatic form .Patient is a 91 year old female with PMH of asthma, PVD, Diabetes Mellitus type 2, Diastolic CHF , Aflutter , hypothyroidism , and allergies, who presents to facility with after her home provider saw her and concerned for pneumonia and worsening respiratory status. Lab work-up showed elevated WBC of 20.61, low potassium 3.2 , and BNP of 764. Her troponin was also elevated 0.147. Chest CTA done showed atypical infectious process with consolidation at the left lung base and secondary to pulmonary mycobacterium avium complex infection in the bronchiectatic form .

Covid19 Vaccine: Dizziness, and BP persistently elevated though not clearly connected to vaccination Already on extended observation due to epinephrine allergy. Vitals intermittently checked. At 1620 vitals check, BP still elevated and she reported mild dizziness. After 35 minutes from vaccination time, BP had still not improved, and pt was still mildly dizzy and she was advised to go to ER. She refused. Risks of refusal discussed and she still refused - stated she would go home and take her BP meds. PCP and Cardiologist were notified.

Altered mental status R77.8 - Elevated troponin N39.0, R31.9 - Urinary tract infection with hematuria, site unspecified D64.9 - Anemia, unspecified type R40.2431 - Glasgow coma scale total score 3-8, in the field (EMT or ambulance) (CMS/HCC)

patient's son called pharmacy on 5/4/21, stating patient had a stroke and is in hospice care now. un-sure if it is vaccine related or not however in light of johnson and johnson news we wanted to report this

Pt received first dose of COVID-19 vaccine on 5/8/21, pt later became ill with COVID19, presenting to ED for testing on 5/22/2021 but was not admitted at this time because symptoms were more mild and manageable at home. Returned to ED on 5/26 and at this time was admitted for weakness and hypoxemia related to COVID pneumonia. Discharged 6/1/2021

LAb work discovered on 4-23-2021, physician called and reported that red blood cells and platelets were very low. After a second blood test 10 days later, doctor reported that blood transfusion may be necessary. Transfusion was not received. At that time, bone marrow biopsy was ordered by hematologist. Blood condition had changed to myelofibrosis. Additional testing pending CAT scan and ultrasound for thrombosis lower extremities. Continue to suffer from extreme fatigue and feeling of despair.

ED to Hosp-Admission Discharged 7/7/2021 - 7/9/2021 (2 days) Last attending ? Treatment team Chest pain Principal problem Primary Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) Chest pain Unknown Hypertension, essential Yes Mixed hyperlipidemia Yes Stage 2 chronic kidney disease Yes Type 2 diabetes mellitus (CMS/HCC) Yes Disposition: Home CODE STATUS (LOI): Full Code _ Active Issues Requiring Follow-up Chest pain: Unclear etiology patient should have a stress test done after discharge would wait a couple weeks to verify the patient is not developing Covid as the accuracy of the test may be degraded if patient has Covid infection. May be reflux related so we will start patient on on Protonix for the next 30 days can likely stop it after that time period. Patient understands to try Maalox or Mylanta She has an episode of pain like this and should return to the emergency department if she has not undergone stress testing if she has recurrence of the pain. Test Results Pending at Discharge Outpatient Follow-Up Future Appointments Date Time Provider Department Center 10/11/2021 1:20 PM DO FIFTH IM Hospital Course HPI: Chest pain Hospital Course: Patient is a 92-year-old female with 2 episodes of chest pain lasting about 15 minutes each over the past couple weeks. Patient had negative troponins. Patient had prior Covid vaccine. Patient underwent Covid swab as does everybody admitted to this hospital which returned positive. Likely incidental finding. Patient did not have any additional episodes of chest pain unclear is what the underlying etiology is. Would wait for at least 2 weeks to verify that patient is not developing Covid and should undergo stress test after such time is completed. Please follow-up with your outpatient provider to arrange this testing. Patient's been advised to return to the emergency room or seek medical attention if she becomes symptomatic with the Covid including runny nose cough. I do not believe patient to be contagious though I explained to her do not know that with certainty.

Patient presented to ED for abdominal pain, nausea and vomiting. during CT of the abdomen and pelvis a finding suspicious for DVT in the left external iliac vein and left common femoral vein. External venous doppler was done to confirm DVT. impression : Acute DVT throughout the left lower extremity extending from the left lower calf to the left common femoral vein. Patient has been admitted to Medical floor for care

92 year female admitted to hospital for fall on 5/24/2021. Unknown exposures in 14 days prior. Pfizer vaccine 2/25/2021 & 3/19/2021. PCR positive 5/24/2021. Transferred to hospice on 29th. Passed on 5/30/2021. Diagnosis at time of death: ARF on chronic with hypoxia, hematoma anterior chest wall left hip and upper thigh, suspected mild heart failure preserved ejection fraction, mechanical fall, delirium, bilateral PNA, pulmonary HTN, acute encephalopathy.

Severe Hypotension, Redness, Warmth and sensitivity all over skin surfaces, lack of responsiveness, low oxygen saturation.

Patient tested positive for COVID-19 by rapid test on 1/6/21. She began to demonstrate a dry cough on 1/11/21. On 1/12/21 at 1723 her oxygen saturation dropped to 79% and oxygen was applied at 4L per nasal cannula. On 1/19/21 at 2130 Patient was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated.

1/27/2021 01:30 NURSE CALLED TO 3RD FLOOR UNIT BY CNA FOR EMERGENT SITUATION IN PROGRESS. FOUND RESIDENT BENT OVER FORWARD IN CHAIR AT BEDSIDE GASPING FOR AIR, RESIDENT STATES "HELP I CAN'T BREATHE, RESIDENT IS PALE IN COLOR AND STATES SHE IS WEAK IN STAMINA, VS 97.9 70 24 168/50 SPO2 87% ON RA, O2 APPLIED AT 2L NC, RESIDENT STATES SHE WANTS TO GO TO HOSPITAL, SHE STATES SHE IS AFRAID SHE IS GOING TO DIE. CALL PLACED TO EXCHANGE TO INFORM ON CALL MD, NP RETURNED CALL AND GAVE NEW ORDERS FOR STAT LABS, CXR, AND BREATHING TX, AND INCREASE O2 TO 6 LITERS, RESIDENT STATES NO I WANT TO GO TO THE HOSPITAL NOW, ON CALL N.P. INFORMED AND AGREES WITH RESIDENT TO SEND OUT. O2 SATS DECREASING WITH 6L TO HIGH 70'S LOW 80'S, AMBULANCE CALLED, POA NOTIFIED, ON CALL NURSE MANAGER NOTIFIED, REPORT CALLED TO HOSPITAL 1/27/2021 02:00 AMBULANCE ARRIVED AND RESIDENT PLACED ON NON REBREATHER MASK SHE IS SAYING I TOOK THE SECOND SHOT OF COVID-19 VACCINE AND SHE FEELS SHE IS HAVING A REACTION TO IT. TRANSPORTED TO AMBULANCE VIA GURNEY 1/27/2021 03:17 HOSPITAL CALLED FACILITY WITH UPDATE, RESIDENT IS POSITIVE FOR COVID-19, SHE IS BEING ADMITTED FOR RESPIRATORY DISTRESS AND WILL BE PLACED ON BIPAP OR INTUBATED IF NO IMPROVEMENT IN BREATHING. ON CALL MANAGER UPDATED, HOSPITAL CALLING POA TO UPDATE

Pfizer-BioNTech COVID-19 Vaccine EUA: One day after vaccination patient reported left arm and chest pain (over pacemaker), shortness of breath, and nausea resulting in poor oral intake. Initial vital signs in the emergency department within normal ranges except blood pressure 135/60 mmHg. No fever, cough, or dermatologic symptoms reported or noted. Only neurological symptom noted was lightheadedness. Patient administered aspirin, antibiotics, intravenous fluids, and acetaminophen and observed overnight. Pain improved with acetaminophen. Vitals were within normal ranges during observation period and symptoms resolved. Cardiology evaluated patient, determined pacemaker functioning appropriately, and patient discharged to home stable.

faint; slightly dizzy; weak; This is a spontaneous report from a contactable nurse (patient). A 92-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL9262), intramuscular in the left arm on 01Feb2021 12:30 at a single dose for covid-19 immunization. The patient has no medical history and concomitant medications. On 02Feb2021 16:00, the patient faint, slightly dizzy, weak and had to grab counter. Within 5-10 minutes it was gone and she was feeling fine. The patient added that it would have been serious if she hit the floor, but she did not. The outcome of the events was recovered on 02Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events faint, slightly dizzy and weak with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

DX: CVA History The patient is a 92 y.o. female with a past medical history notable for History of CVA, history of arthritis, history of COPD, history of DVT, history of reflux, history of hypertension, history of hyperthyroidism, recent GI bleed. The patient presents for evaluation of worsening weakness at skilled care facility. Patient had history of stroke. Patient was assessed there was found of have another stroke. Patient's other care and therapies were reviewed. Patient's blood thinners recently stopped within the last 3 months due to GI bleed requiring multiple transfusions. Patient has been slow to recover. Patient has struggled with intake and weight loss. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.

The patient has developed an acute deep venous thrombosis in the right popliteal and trifurcation vessels of the calf. She has an elevated d-dimer of 14,738 and acute hypoxic respiratory failure due to pulmonary embolism.

she had not been eating properly; she was found lying on floor of her house - likely having been there for 3 hours. Next morning found lying on the floor of the bathroom; On helping up she was confused but otherwise ok; she was found lying on floor of her house - likely having been there for 3 hours. Next morning found lying on the floor of the bathroom; This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose of bnt162b2 (Formulation: Solution for injection, Lot number: EK1768), via an unspecified route of administration, on 15Jan2021 at single dose for COVID-19 immunisation. Medical history included t2diabetes, hypertension, arthritis, previous episodes of falling. The patient's concomitant medications included rampril, glimepiride, gabapentin, sitagliptin, atorvastatin, tolterodine l-tartrate (PREBLACON) all at unspecified doses. It was reported that on 16Jan2021 at around 6pm she was found lying on floor of her house - likely having been there for 3 hours. On helping up she was confused but otherwise ok (as reported). She remained ok for several hours before going to bed. Next morning found lying on the floor of the bathroom. It was reported that ambulance was called but did not go to hospital due to COVID risk and overcrowding. It was reported that blood sample was taken on an unknown date in 2021 and analysed. The doctor called and reported no abnormal findings in blood sample. Suggested possibility that she had not been eating properly. The outcome of the event she had not been eating properly was unknown, while for other events was recovering. The events occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported event Syncope cannot be completely excluded given the known suspect drug profile and/or implied 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 Regul atory Authorities, Ethics Committees and Investigators, as appropriate.

Chest pains. Hypertension of 230/118 at 1:45pm 3/3/21. 2 hours after receiving Covid vaccine. Went to ER. Evaluation with EKG, chest X-ray, lab work. Chest pains subsided. Hypertension continued 212/109. Medications administered for blood pressure which was lowered after approx 4 hours.

DVT in right leg discovered after swollen foot on 2/25/2021 via ultrasound. Clot extends from mid thigh to mid calf. Placed on Xarelto 15 mg 2x/day until next imaging appointment on March 30, 2021. First incident of blood clot for mother.

her mother didn't want anything to eat; her mother wasn't making any sense when she talked; Dizzy; Weakness; shaky; stomach became upset; her mother had a pretty severe headache come on; Nose bleeds; Blood pressure increased; her mother's comprehension is not at the same level as prior to being hospitalized; This is a spontaneous report from a contactable consumer. A 92-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm on 15Feb2021 12:30 at SINGLE DOSE for covid-19 immunisation. Medical history included blood pressure high, high cholesterol. Caller stated her mother has had high blood pressure for around 15 years. She said her mother's blood pressure medicine has changed over the years, providing her current blood pressure medication as: Ramipril 2.5mg capsule, once a day, Bisoprolol 5mg tablet, once a day. Reported her mother has had high cholesterol for at least 30 years. She said her mother's cholesterol is controlled with Simvastatin 40 mg, once a day. She said her mother has been on Simvastatin for at least 10 years and her mother's Simvastatin dose has been bumped up gradually over that time. She said the Simvastatin 40mg is dispensed in a pharmacy bottle with no NDC, Lot, and expiration date. Concomitant medication included omeprazole (OMEPRAZOLE), simvastatin (SIMVASTATIN) for high cholesterol, ramipril (RAMIPRIL) for blood pressure high, bisoprolol (BISOPROLOL) for blood pressure high. The patient experienced nose bleeds on 18Feb2021 with outcome of recovered on 22Feb2021, her mother had a pretty severe headache come on on 18Feb2021 with outcome of not recovered, blood pressure increased on 18Feb2021 with outcome of recovering, dizzy on 20Feb2021 with outcome of unknown, weakness on 20Feb2021 with outcome of not recovered, shaky on 20Feb2021 with outcome of unknown, stomach became upset on 20Feb2020 with outcome unknown, her mother didn't want anything to eat on 21Feb2021 with outcome of unknown, her mother wasn't making any sense when she talked on 21Feb2021 with outcome of not recovered, her mother's comprehension is not at the same level as prior to being hospitalized on an unknown date with outcome unknown. The patient was hospitalized from 21Feb2021 to an unknown date. Reporting on her 92 years old mother who received her first Pfizer COVID-19 Vaccine dose last Monday, 15Feb2021. She said the first couple days her mother was fine after receiving the COVID-19 Vaccine. She said on Thursday, 18Feb2021, her mother had a pretty severe headache come on. She said her mother normally doesn't have headaches. She said her mother began having nose bleeds that started on Thursday (18Feb2021), and continued on Friday (19Feb2021), and Saturday (20Feb2021). She said her mother's blood pressure was up during that time, as well. She said on Saturday night (20Feb2021) at 9:00 PM she took her mother to the Emergency Room because her mother's blood pressure was very high. She said a CT scan of her mother's head was done and was negative for a stroke. She said her mother was kept in the Emergency Room and monitored. She said her mother's blood pressure was gotten under control with given blood pressure lowering medication in the Emergency Room and her mother was discharged home at around midnight. She said she does not know the name, dose, NDC, Lot, and Expiration Date for the blood pressure medication. Reported her mother takes Warfarin for blood clots. She clarified her mother is monitored monthly and her mother's Warfarin is adjusted accordingly. She said her mother takes a Warfarin 1mg tablet daily on Monday through Friday, and a 1/2 Warfarin 1mg tablet (0.5mg) on Saturday and Sunday. She said the Warfarin is dispensed in a pharmacy bottle with no NDC, Lot, and Expiration Date. She said her mother has been on Warfarin for around 20 years, since her mother had a blood clot. Reported her mother takes a stomach medication, clarified as Omeprazole 20mg capsule once a day. She said her mother has been on Omeprazole for years. She said the Omeprazole 20mg capsule was dispensed in a pharmacy bottle with no NDC, Lot and Expiration Date. She said her mother's stomach had been fine. She said her mother didn't get sick to her stomach, until the night she was released from the Emergency Room (20Feb2021). She said when her mother sat up and tried to stand while she was in the Emergency Room on Saturday night (20Feb2021), her mother was dizzy, and felt weak and shaky. She said her mother was given some orange juice and peanut butter crackers at the time. She said her mother's stomach became upset then. She said she thinks her mother's stomach upset had more to do with having the orange juice and peanut butter crackers than anything else. She said her mother has never had nose bleeds or headaches before. She said her mother has blood pressure issues that she takes blood pressure medicine for. She said she thinks the COVID-19 Vaccine may have exasperated her mother's issues. Reported on Sunday (21Feb2021), her mother didn't seem much better to her. She said her mother's blood pressure was up, her mother was dizzy, weak and had a bad headache. She said her mother has a healthy appetite for 92 years old and her mother didn't want anything to eat. She said she ended up calling 911 because her mother wasn't making any sense when she talked. She clarified her mother was picked up by the ambulance at 9:00PM on Sunday (21Feb2021); and admitted to the hospital. She said her mother is still in the hospital as of today, Tuesday, 23Feb2021. She said her mother had a CT scan, a MRI, and an EEG. She said the CT scan, and MRI were negative, and the EEG results were not back yet. She said her mother may be released home today, 23Feb2021, depending on the EEG results. Reported her mother has never had nose bleeds or headaches before. Reported on Sunday, 21Feb2021, she took her mother's blood pressure. She said her mother was very weak and incoherent. She said her mother was unable to comprehend the way she usually does. Reported her mother has had no more nose bleeds since yesterday 22Feb2021. She said her mother is still quite weak, but her blood pressure is now under control. She said her mother has been on a stroke watch while at the hospital, and her mother has not been allowed to get up out of bed as of last night (21Feb2021). She said the hospital staff are supposed to let her mother walk today (23Feb2021) to see if her mother's blood pressure stays stabilized. She said her mother's comprehension is not at the same level as prior to being hospitalized. She clarified her mother still drives a car at 92 years old and takes care of her own check book. She said she doesn't know if her mother will still be able to do that at this time. Reported her mother was checked for a UTI while at the hospital. She said the hospital went ahead and treated her mother for a UTI without knowing if her mother had a UTI. She said because her mother is elderly, a lot of times the elderly have UTIs. She said the hospital didn't want to waste time and went ahead and treated her mother for a UTI because her mother hadn't been on antibiotics recently. The caller stated she did not have any information on the medications her mother has been given while at the hospital. Reported at first she did not think her mother's symptoms had to do with her mother's first COVID-19 Vaccine dose, but then there was a new part to her mother's story that made her think her mother's symptoms had to do with the COVID-19 Vaccine. Caller stated she is apprehensive for her mother to go get her second COVID-19 Vaccine shot. The patient underwent lab tests and procedures which included blood pressure abnormal: up on 18Feb2021, Head CT: negative on Feb2021, Head CT: negative for stroke on 20Feb2021, EEG: unknown results on Feb2021, MRI brain: negative on Feb2021. Therapeutic measures were taken as a result of nose bleeds, blood pressure increased, dizzy, weakness, shaky.

Leg Pain 03/03/2021 Erratic BP episode 03/11/2021 9:00am BP 202/117, P78 After 15 minutes BP 108/65, P77 10:00am BP 172/86, P79 12:00 pm BP 138/75, P79 Dr. was called and is having us monitor her.

Patient was taken by ambulance to E.R. 3 days after injection with bleeding from the nose and blood in stool. Spent 10 days in hospital. Returned to ER a few days later with fluid leaking from arms and legs. Diagnosed with congestive heart failure. Sent home under Hospice. Returned to ER, by ambulance, 36 hrs. later. Still weeping from skin and placed in ICU. on Bipap machine . Transferred that evening to medical Care Center where she passed away on March 3, 2021.

After vaccine was administered patient was seemingly fine until a loss of consciousness/mini stroke on Jan 16 (5 days after vaccine) causing a fall and massive stroke on Jan 22 (11 days after vaccine) that left patient unresponsive and on life support until family decided to stop services and begin hospice care with no fluids or food until death

Found in chair lethargic less than 48 hours after her first civid vaccine by facility staff where she lives in an independent living facility. Nursing staff felt she had a stroke with right sided weakness. Slurred speech, weak, unable to walk without two person assistance. Patient was under hospice care so hospitalization was given.

TIA 3/16/2021 and moderate stroke on 3/18/2021 resulting in ischemic area left temporal and occipital lobe. Injury affecting speech, memory, and cognitive abilities. unable to live independently as prior to the event.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient recieved vaccine and was helped to observation area. About 3-5 minutes after vaccination the patient told her son that she felt hot and then her head slumped forward. She became unresponsive to verbal/ physical stimulation. Patient vomited and would have fallen out of her chair if she had not been caught. She also made some noises from her throat that sounded concerning. EMS was immediatly called and epinephrine administration was attempted. Epi not given. Pt recovered and taken to ER.

Asymptomatic Thrombocytopenia noted on routine labs prior to second vaccination. Still requires hematology follow-up and immunosuppression.

Hospital admission due to COVID-19 positive result. Patient tested positive on 4/7/2021. Patient was hypoxic and had a cough on admission. Patient was diagnosed with COVID pneumonia, was given Remdesivir and decradon. Patient was discharged on 4/17/2021

Presented to ED on 1/12/21 slowly worsening constant myalgias, generalized weakness where she couldn't walk, dry cough. Per daughter not acting herself and more confused. Clinical impressions included hypoxia, COVID-19. Pt is s/p her first dose of vaccine and this precludes plasma. Supportive care steroids and doxy. Family faxed DNR on 1/12/21 at 2225. Remdesivir given 1/13/21 at 1am. 1/13/21 note at 1:30am: Pt's O2 sat fluctuating btw 80%-90%. Increased NC success pt O2 sat continues to decrease. NRB 15L in place O2 Sat 90%. Pt became pulseless and expired at 0451.

Patient presented to the ED and subsequently hospitalized for CVA within 6 weeks of receiving COVID vaccination.

patient with hx of thrombocytopenia received vaccine and presented to hospital with thrombocytopenia with platelet count of 6

Inability to "recall how to walk" and needed standby assistance; followed by onset of significant edema (more than pitting 2) of legs/feet; significant elevation in blood pressure, drop in oxygen saturation; required emergency hospitalization in cardiac unit for acute heart failure

Immediate fatigue that has persisted for months. I fall asleep all the time since getting the vaccine and feel unstable. This is a sudden change upon getting the second dose. Also this week pain in left arm and chest, severe pain in heart area but a strong pulse.. My body does not feel normal. I began to notice something was really wrong within two days of getting the second shot.

Patient admitted on 7/5/21 from nursing home with acute hypoxic respiratory failure. Patient diagnosed with COVID pneumonia and CHF exacerbation. Patient was treated with oxygen, steroids, and remdesivir, Patient returned to baseline and was discharged on 7/8/21.

RESIDENT COMPLAINED OF CHEST PRESSURE AND DIFFICULTY BREATHING ABOUT 1 HOUR AFTER VACCINE ADMINISTRATION. SENT TO HOSPITAL FOR EVALUATION. RETURNED HOME 2 HOURS LATER. SPOKE WITH RESIDENT AT 830am ON 1/7/21 AND SHE REPORTED SHE FELT FINE AND FELT SHE MAY HAVE HAD A PANIC ATTACK. SPOKE WITH RESIENT AT 830AM ON 1/8/21 AND SHE REPORTED SHE FEELS FINE.

Symptoms: Headache, dizziness, feeling spaced out, and head fullness. BP elevated 152/75. Resolved on its own after 30 minutes from injection time.

During injection she felt it burning; Her Blood Pressure went up to 255; She felt weakness and Nausea; Became unaware of her surroundings.

Stroke within 48 hours of shot on 1/22/2021. L sided weakness, facial droop, slurred speech, confusion, . to this writing (2/4/2021), symptoms persist.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Medium, Systemic: Tachycardia-Mild

Patient became dizzy, tachycardic and hot after getting her second COVID vaccine. She was monitored and discharged home with her daughter, who is her caregiver.

My mother died on February 19, 2021. She had her 2nd dose vaccine on 2/11, on 2/12 it was noted that she was not able to walk, on 2/13 she was walking at 30%, on 2/14 she was walking with difficulty, on Monday 2/15 she was throwing up violently and her blood pressure dropped, so she was sent to Clinic. My sister was told she was just constipated and she had A Fib (never reported before to us). My sister was then told on 2/16 early a.m. that she had a blood clot that destroyed her colon. Due to age surgery would likely not be successful. She then died on the Friday. We are reporting in the event that the Pfizer vaccine was somehow a contributing factor to the A fib or to the Clot. She has no history of A fib or clotting prior to this incident. She was 93, and did have dementia, but was able to eat normal foods prior to this. What was unusual was the challenge in walking the day after the shot. Other than that no difference was observed until the day she was admitted to the hospital emergency room. She was a resident at Assisted Living, Memory Care, and that is where she received the vaccine. The mailing address I provided is her mailing address prior to death.

Injection site became pink, 3X5 inches, the day following the shot. On 2.11.2021, about 55 hours after vaccination #2, pt developed generalized weakness, nausea, and then vomited. She was taken to bed, where she rested poorly and only dozed off for 1-2 minutes at a time and was mumbling words. She continued with generalized weakness, nausea with dry heaves, a sensation of marked shortness of breath, and inability to stand without support. Complained of feeling hot and then cold. Appeared pale and lethargic, skin clammy and complained of difficulty breathing and was irritable. Lung sounds -clear, no wheezing despite being unable to speak more than a few words at time. Vitals at 10:00pm: HR 62, pulse weak, O2 sat 92% (normal for her), temp 101.7F (her normal temp is 95-96). Given a Tylenol extra strength 500mg, 2.5 mg Prednisone, increased O2 nasal canula to 3-4 L/min, and cold compresses to reduce fever and discomfort. Vitals at 10:15p: HR 93, O2 sat 92%, BP 131/59. Discussed going to the ER, but decided to wait until the morning if not better. Symptoms continued until ~ 2am, when she was able to fall deep asleep for 4 hours. Awoke and felt better, able to walk, but still a bit weak and short of breath. By noon Feb 12 she felt mostly back to normal.

Patient stated that she felt anxious and nervous, heart racing. Blood pressure initially 197/102, HR: 99, spo2: 98%, RR: 17, TEMP: 97.4 T, Skin color pink warm and dry. Patient awake alert and oriented x3. Heart rate and rhythm regular. B/L BS CTAwith good aeration. At 0956, BP 207/110, HR: 100. AT 1000, B/P 191/100. PCP's office contacted to notify, message left with nurse. Patient placed in supine position B/p : 210/90 at 1010, at that time, EMS activated, 1020: B/ P: 190/ 100, at 1039, B/ P 175/93. Patient stated that she felt better. Upon EMS arrival at B/P 154/94. Patient decided not to see medical attention and wished to go home with daughter.

garbled speech; spasms; Mouth/lips twitching/twitching; arms rigid up toward face; lips blue; rapid breathing; deep sleep after; glazed look; not responding; bite tongue; This is a spontaneous report received from a contactable healthcare professional also reported as a nurse. A 93-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Batch/Lot Number: EN5318) intramuscular, administered in Arm Left on 28Feb2021 at 14:30 as SINGLE DOSE for covid-19 immunisation Facility where the most recent COVID-19 vaccine was administered was a Home/Facility. Medical history included cerebrovascular accident 'CVA 8 months ago' from Jul2020 to an unknown date , atrial fibrillation from an unknown date and unknown if ongoing. The patient has no known allergies. Historical Vaccine included BNT162B2 Dose 1, Lot number EL9621, Administration date 07Feb2021 at 14:00, Intramuscular, in the Left arm for Covid-19 immunization. Concomitant medication included asa (ASA); levothyroxine (LEVOTHYROXINE);metoprolol (METOPROLOL); bupropion (BUPROPION); docusate sodium (COLACE); apixaban (ELIQUIS); iron (IRON); latanoprost (LATANOPROST); omeprazole (PROTONIX [OMEPRAZOLE]); timolol (TIMOLOL); paracetamol (TYLENOL). 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. On 2021, The patient experienced spasms, mouth/lips twitching/twitching,arms rigid up toward face, lips blue, rapid breathing, deep sleep after, glazed look, not responding, bite tongue and on Mar2021 garbled speech. on Mar2021. The events Mouth/lips twitching,arms rigid up toward face, spasms, twitching, glazed look, not responding, bite tongue, lips blue, rapid breathing, deep sleep after, garbled speech was considered Disabling/Incapacitating. Clinical course was reported as follows Mouth/lips twitching, arms rigid up toward face, spasms, twitching, glazed look, not responding, bite tongue, lips blue, rapid breathing, deep sleep after, same repeated 4 hours later and then again 1 hour after that. next day garbled speech, not exhausted and stayed in bed 4 days. It was unknown if treatment was give for the events. The clinical outcome of the events was recovered with sequelae. .

sleeping for 20 hours for four days after vaccine, low grade fever, chills, intense pain in right hip and left leg -intensification of arthritis pain, inability to walk on own, swollen left ankle due to inflammation, glucosed level increased for 1 1/2 weeks levels 171 to 261, brain fog , unable to do puzzles (puzzles helps with dementia. Symptoms subsided after 2 weeks and 1 day; brain fog still subsiding, almost back to level before vaccination.

She received her first COVID vaccine on 1-13-21 and her second on on 2-3-21. She was hospitalized for shortness of breath and multiple subsegmental pulomnary emboli without acute cor pulmonnale. Other active hospital problems were: acute hypoxemic respiratory failure due to CVOID-19, acute kidney injury, lower limb ischemia. Patient was admitted to the hospital on 6-22-21 and tested positive for COVID-19 on 6-30-21. Patient was put on comfort measures on 7-9-21 and died at the facility on 7-12-21.

Site: Pain at Injection Site-Medium, Systemic: Generalized Body Aches -Severe, Systemic: Headache-Severe, Systemic: Severe drop in blood pressure, pulse, and o-sat-Severe

admitted to hospital 1/11/2020 with Acute respiratory failure with hypoxemia; Iron deficiency; SOB (shortness of breath); Symptomatic anemia; still admitted

over about an hour increasingly achy, arm pain, fever, nausea, high blood pressure, lower lip numb (sometimes a sign of a TIA), some confusion (sometimes the sign of a TIA) The severe nausea came in waves, lasted a couple of hours and cleared by Midnight before she went to sleep.

Chest Pain started about 5-7 minutes after getting injection. Rated 8/10. Has a cardiac history and wanted to be seen in ED. 911 called for patient.

Patient began feeling nauseated on 1/18/21 around 6pm, and had uncontrolled diarrhea, reported that she did not feel right. Staff reported to this writer, that her skin tone was gray in tone and she just didn't look good. She was transferred to the HOSPITAL ER VIA AMBULANCE.

1/18/2021- Tested positive for Covid-19. 1/20 Patient lethargic, unable to swallow. 1/24 Although 90% O2 sat on RA, it has decreased from her baseline ranging at high 90's. 1/27/2021 Patient passed.

94 yo F presented from assist living with slur speech for 1 day, last seen well on 1/30. Pt has a PMH of dementia (Baseline, she will keep saying, "help me, help me", AOX3, using walker, could go to bathroom by herself), hx breast cancer (s/p lumpectomy, chemo, Tamoxifen, currently not on tx), HTN, HLD, vaginal bleeding (no further work up by family), overactive bladder (on solifenacin), hx of MI (undocumented, no PCI or CABG), spine stimulator placed. According to patient's daughter, she saw her January 30, she was doing okay after the vaccine. On 1/31 when the daughter called her on the phone, she knows she has some slurred speech, when she saw patient in the facility, she noticed her gait becomes unsteady. She decided to bring her to the hospital. 1/30, she noticed the patient has spilled up some water, otherwise denies fever, chills, shortness of breath, pain, chronically, she has constipations taking laxative. In the ED, pt was afebrile, 36.1, heart rate 85, blood pressure 130/61, respiratory rate 18, saturations 98 on room air. Labs shows, sodium 134, potassium 3.6, bicarb 28, BUN 18, creatinine 0.97, glucose 119, WBC 12.5, hemoglobin 11.8, platelet 239. PT INR 1.09, COVID negative. CT head suggestive of subacute infarct. Possible including small vessel ischemic changes. Chest xray questionable patchy left retrocardiac atelectasis or pneumonia. EKG shows atrial fibrillation's heart rate 71, QTc 610. Case was discussed with neurology in the ED, patient was not a TPA or embolectomy candidate. CT head suggestive of acute/subacute cerebellar infarct. Patient does not have any residual or sensory deficit except expressive aphasia. Neuro saw patient, mentioned patient appears to have had a stroke that by the CAT scan criteria is already subacute. The patient was admitted on the stroke pathway. The patient has new onset atrial fibrillation and therefore should be considered for anticoagulation. The patient cannot have an MRI of the brain due to her spinal cord stimulator but given that the stroke is already subacute on the CT without any signs of hemorrhagic conversion she could be started on this at this point. If she gets started on anticoagulation the aspirin should be stopped. If the patient cannot go on anticoagulation or does not want to then she might be a candidate for dual antiplatelet therapy for secondary stroke prevention. 2D echo shows normal ejection fraction of the left ventricle estimated at 70 to 75%. Regional wall motion abnormality was not observed. Right ventricle systolic function is normal. Moderate aortic stenosis. Cardio was consulted for anticoagulation, From cardioembolic prevention standpoint, anticoagulation is recommended to prevent CVA. However, she has significant risks for bleeding given recent vaginal bleeding (investigation not pursued to spare her comfort), age, comorbidities, etc. Again, further discussion between family and primary team is required regarding risks vs benefits. Was evaluated by speech-language pathology present minimal oral dysphagia no overt clinical signs of aspiration, recommended to continue with NDD 2 diet/thin liquid. Patient was discharged to ECF.

Stroke; This is a spontaneous report from a contactable consumer. A 94-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 16Jan2021, at single dose, for COVID-19 immunisation. Medical history included ongoing hypertension (took medication). Patient did not have COVID-19 prior to vaccination. Concomitant included unspecified medication for hypertension. The patient experienced stroke on 31Jan2021. The patient was brought to the emergency room and hospitalized due to the event on 31Jan2021. No therapeutic measures were taken as a result of the event. The patient underwent lab tests and procedures which included COVID-19 virus test: negative in Feb2021 (a week before report); investigation: brain bleed and discovered she had a stroke (on unknown date in 2021). The patient died on 03Feb2021 due to stroke and old age. An autopsy was not performed. Patient's family did not attribute her death to the vaccine at all. The information on the Lot/Batch number has been requested.; Reported Cause(s) of Death: stroke; Old age

Patient had swelling around her jaw after her second shot of the covid , Pfizer vaccine ( .5 ml IM) on the Friday morning, January 29th, I took her to a follow up appointment with the cardiologist at 3:00 pm, as a follow up to a small heart attack event with hospitalization two weeks previously, at the cardiologist she was given the ok/all is well. That next morning early, she had a 911 event at her assisted living apartment and was sent back to the hospital, having had another heart attack. Patient died on the following Thursday, February 4, 2021. I do not know if the vaccination had any cause for my mothers death; but I feel it is necessary to report this series of heart attacks after she received the pfizer vaccine. Her Certificate of Death records the cause of death as "Coronary Artery Disease".

My mother had a stroke on 28Jan2021 sometime after 9:30 AM the morning after getting the first dose of the Pfizer Covid vaccine; Cerebral infarction; This is a spontaneous report from a contactable consumer (reporting for mother). A 94-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown as not available or provided to reporter at the time of report completion) via an unspecified route of administration on 27Jan2021 in right arm at single dose for COVID-19 immunization. Medical history included coronary artery disease and hypertension. There were no concomitant medications. The patient was not pregnant. No other vaccine was received in four weeks. The patient did not have covid prior vaccination and not have covid tested post vaccination. The patient had a stroke on 28Jan2021 sometime after 9:30 AM the morning after getting the first dose of the Pfizer Covid vaccine and was hospitalized due to stroke for 6 days from Jan2021. The patient then experienced cerebral infarction in 2021 and died due to it on 04Feb2021. Treatment received for events stroke and cerebral infarction included tPA injection. The outcome of events stroke and cerebral infarction was fatal. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cerebral infarction

Vertigo last week that stayed for five days; pain at the injection site; 2 stroke like symptoms/ like she was having a TIA (Reporter confirmed TIA as Transient ischemic attack); Blood Pressure 170/130; Fatigue; Joint ache; Nausea; Vomiting; Fever 100.1; Stress; 2 stroke like symptoms/numbness in her lip; Pervasive aching; Momentary confusion; , like she was having a TIA; Not able to answer questions; she still has not recovered her strength; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old female patient (mother) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1283), via an unspecified route of administration on 23Jan2021 13:00 at a single dose for COVID-19 immunisation. The patient's medical history included ischaemic stroke, haemorrhagic stroke in Aug2019, pulmonary embolism, deep vein thrombosis (DVT), cholesterol, myalgia condition, blood pressure, thyroid, sleep and vertigo. The patient concomitant medications included amlodipine for blood pressure, calcium carbonate/colecalciferol (CALCIUM + VITAMIN D), rosuvastatin calcium (CRESTOR) for cholesterol, levothyroxine for thyroid, eszopiclone (LUNESTA) for sleep medication, ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2), prednisone for myalgia condition, and escitalopram. The patient experienced fatigue, joint ache, nausea, vomiting, blood pressure 170/130, fever 100.1, stress, stroke like symptoms, numbness in her lip, momentary confusion; like she was having a TIA; not able to answer questions, tired, pervasive aching, all on 23Jan2021 19:00. Events reported as follow: patient had the Pfizer vaccine on Saturday around 1 pm and Saturday (Clarified 23Jan2021) night she had severe side effects for about 4 hours. When probed for side effects, the reporter stated it increased gradually over time. So, first patient had joint achiness and then she experienced nausea and vomiting. The reporter took her blood pressure. It was 170/130 and so reporter called EMS and they came up and her blood pressure had gone back down to normal and they recorded she had a fever of 100.1. EMS believed that the combination of the 'violence' of the onset and the fever caused her blood pressure to spike but she had a history of ischemic and hemorrhagic stroke. So, the reporter was concerned that the stress and whatever that was going on the reaction, the reporter was concerned that it was going to cause her a stroke. Patient had 2 stroke like symptoms, one was that she had numbness in her lip and the second was that she had momentary confusion, like she was having a TIA (reporter confirmed TIA as Transient ischemic attack). The only symptom of that was when the reporter asked her the name of her children she gave the names of her grandchildren but that confusion cleared up quickly and she was fine for a while but not able to answer questions, sharply. By the time that EMS got there patient was sharp again, no problem. For treatment, the reporter gave patient aspirin. The reporter put some Salonpas patches on her joints. It was like the analgesic patch. It was an external patch that patient put on. Patient usually does not need them that was why she was taking the prednisone to treat that kind of pervasive aching. The reporter also gave her the fluids, Gatorade kind of stuff to replace her fluids from throwing up and that kind of stuff. One more thing, it all started with an extreme fatigue but that seem normal but it seemed to lead into the other symptoms. Like it was a big day to go out and get the vaccine. So, she was a little bit tired. This was a very deep fatigue that was part of it too. Reporter stated only 81 aspirin (later clarified as treatment) as she could not go back on blood thinners because she had the hemorrhagic stroke. As of 11Feb2021, it was reported that patient still has not recovered her strength since 23Jan2021 19:00 and was reported as ongoing but improved. On 03Feb2021, the patient had vertigo that stayed for five days and was now improved. The patient was scheduled for the second dose on 13Feb2021. The immediate effects her mother had after the first dose of the vaccine were pain at the injection site; fatigue; fever; nausea. Mentions she also had some confusion and they were worried that the patient might be having another stroke. But all of this cleared up; all of this in a violent episode that lasted about four hours. Today she wants to report that her it took her a week for her mother to recover. Adds her mother could walk for half an hour before the vaccine but since the vaccine she still has not recovered her strength. Adds her mother has only been able to walk about 15 minutes with a walker and resting a lot, for a couple time in three weeks and this was their main way of maintaining her health. Adds her mother also had some vertigo last week that stayed for five days but she has had that in the past. Adds actually she still has the vertigo a little and she can tell when her mother bends her head. Outcome of blood pressure 170/130, she still has not recovered her strength and vertigo was recovering, outcome of events pain at the injection site, fatigue, fever, nausea and confusion was recovered on 23Jan2021 23:00; other events was unknown. No investigation assessment. Follow-up (11Feb2021): New information received from the same contactable consumer (patient's daughter) includes: reporter details, medical history, reaction data and course of events.

Client reported a metallic taste in her mouth, heaviness in her chest, headache, lightheadedness. On site EMS attended to client. B/P 130/70, EKG done-normal sinus rhythm. Client declined to be transported to the hospital. Client monitored for 30 minutes, reported that she felt "a little better" and wanted to go home. Client driven off site by her daughter. Client and daughter encouraged to call 911 in case of emergency and follow up with primary doctor. Verbalized understanding.

Day after vaccination pt found hypotensive at facility (SBP 70), pale. Has leukocytosis. No etiology found on blood tests, exam or imaging yet.

The vaccine (#2 in series) was administered in the drive through clinic. During the 15 minute waiting period, the patient developed headache, then began to have chest pressure and shortness of breath. She was given depo medrol 80 and benadryl 50mg. She was further evaluated and found to have blood pressure of 200/100 and oxygen saturation was 80 % . She was transferred right away to ambulance and transported to ER. She was able to stand on her own to transfer to the gurney to be transported. We have not been able to have follow up as of yet; she is not a patient of Health Center so records have not come to me (nor can they be released to me) from the hospital. We are continuing to try to reach the patient or her family to follow up on this case. I will update this report as more information becomes available to me. * the Regional Covid-19 Vaccine Clinic is a collaborative effort of Health Center, the Health Dept, Regional Hospital, and Pharmacy. Vaccines are given to all qualified residents, so the patients coming through on a certain day may or may not be the patients of the physicians working that day.

10:00 94 yo female c/o N/V while she was sitting in a chair at post vaccination observation area. Pt's Son took the patient to ladies room, Patient vomited x1. c/o diszziness. Onsite paramedic responded and transferred the patient in a strecher to the EMS observation area. 10: 10 peripheral pulse weak P 84, BP 100/70, R20 ( with supine postion), The patient refused to be transferred to ER. family member( son) wanted to transfer the patient to ER. 10:20 peripheral pulse: weak. P 82, BP 107/70, R 20( supine postion) 1050 peripheral pulse :weak, P 84, BP 105/75, R20 ( supine postion) 11: 00 P41,BP105/60, R 40 Patient agreed to transfer to ER. 11:15 Called 911 to transfer the patient

pt received her 2nd pfizer covid 19 vaccination on 4/1/21. she presented to the er on 4/16 with family with c/o 3 days of poor oral intake, diarrhea, weakness and confusion. family reported deterioration over the last 2 weeks. she was initially hemodynamically stable in the ER initially then became bradycardic and hypotensive. oxymask was placed. blood work revealed neutrophilia, anemia, mildly elevated ast and a markedly elevated troponin. she was admitted with non ST elevation MI, acute encephalopathy which ultimately progressed to coma, acute renal failure, progressive thrombocytopenia. cardiology saw her. she was started on a heparin drip. infectious cause for her symptoms was not found. her ef was 40% on echo. she expired on 4/20/2021.

Received first vaccination on Feb. 4, noted decreased activity approximately 3-4 days after receiving vaccination. As time went on begin to stay in the bed more and more. Complaint feeling tire and unable to walk short distance without getting out of breath. Decreased strength and increased fatigue. Feb. 25 received second vaccination approximated 3-4 days after receiving vaccine, became very unbalanced, and falling. became short of breath while without any activity. Went to physician on 03/04/2021 Hemoglobin 7.5 was hospitalized had to receive multiple blood transfusion.

got first COVID vaccine shot mon 4/26/21. two days after shot Wednesday, 4/28/21, she could not be woken, she was unconscious , like comatosed, we couldnt wake her to eat or drink. Awoke for a few minutes on Thursday, 1/29/21 for very short spurts.. contacted dr by phone. she said keep watching her and try to get her to eat and drink- vitals still fine. but Friday, 1/30/21 BP down to 80/40. Gave her a T of salt and 32 ounces of water. slowly got BP back up by Saturday 5/1/21. today is Sunday, and her BP is back up, but respirations remain down to 54, normally 74. She's eating and drinking. We think we've saved her and we keep praying. dr said second shot not advisable.

Patient admitted on 03/25/2021 through the emergency department for complaint of shortness of breath she was a resident of a Nursing Facility. Her oxygen saturations were into 80%. Patient was poor historian her daughter at the bedside provided most history. Patient with recent admissions for coronavirus on 03/03/2021 and then again on 03/05/2021 for post coronavirus pneumonia. Throughout hospitalization patient with poor appetite, on 03/28/2021 noted to be somnolent, additional blood cultures and labs checked. Patient continue to decline, refused medications. Minimal responsiveness on 04/01/2021. Had episode of PAF on 4/1/21, renal dosed Eliquis per Cardiology. Service discussed with family multiple times about code status, he continued to be on decided home willing to change code status. Patient remained on high-flow oxygen and not eating. Patient very anxious increase work of breathing. Patient died on 04/03/2021.

Tested positive at hospital during outbreak on 4/27, hospital reporting cold-like symptoms until 05/06 when patient was noted to be hypoxic (70% O2 saturation on RA). Patient presented to ED with tachypnea and dyspnea. O2 saturations in ED were in the low 90% and patient did require oxygen supplementation after admission. Received dexamethasone, no remdesivir given time course. Has required HFNC up to 40L/80%. Currently weaning oxygen but still admitted.

Pt had acute ischemic stroke involving right vertebral artery 16 days after dose number one of Pfizer vaccine. She developed sudden dizziness and loss of leg strength, fell to floor. it took 7 hours until she was found and taken to hospital, so did not receive TPA. CTA on 2/27/2021 showed occluded V4 segment of rt vertebral artery. residual deficits currently include imbalance, loss of lower extremity strength (now in wheelchair), loss of hearing and discordant occular movement.

Mom was fine day of incident. After caregiver left, I come to her home around 6, but lost my keys and didn't get there until about 7pm and found her blacked out and appeared to be passed away and dead weight on the floor. Called paramedics and took her to hospital admitted to ICU told she had profuse bleeding around the brain and something to do with her heart and she wouldn't make it through the night and she was in a coma.. Somehow, the neurosurgeon and staff saved her life. She is now in a skilled nursing home. Can't walk without walker and assistance and can't return home.

Delirium, confusion, anxiety, and depression Nausea, no appetite headache, body aches pale, flushed cheeks Low blood pressure

Congestion Shortness of breath Tachycardia Transferred out 911. Per hospital, patient had a myocardial infarction, is unresponsive, and on hospice services.

she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive; This is a spontaneous report from a contactable nurse. A 95-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), Lot# EH9899 Exipration on 06Jan2021 at 15:00 at SINGLE DOSE at deltoid for COVID-19 immunization. The patient received first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), Lot# EH9899 Exipration date : 31Mar20221, on 16Dec2020. Medical history included : cardiac failure congestive, hypertension, cardiac murmur .There were no concomitant medications. The patient previously took cymbalta , vasotec and zocor and experienced drug hypersensitivity. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine.This nurse,worker at a skilled nursing facility, reported that this patient with a history of heart failure, received her second dose of the Pfizer-BioNTech Covid-19 vaccine yesterday, 06Jan2021, at 3pm. At 7am on 07Jan2021 she was transferred to the hospital with tachycardia, congestion, shortness of breath, and is now unresponsive. Patient was stable prior to vaccination, but will now be transferred to hospice care. The nurse added the patient had the second COVID vaccine on 06Jan2021 yesterday and has now been transport to hospital due to a drastic decline after the shot. It was explained that this morning around 7 am she was transferred to the hospital. She was experiencing tachycardia, shortness of breath, and congestion. The events started this morning around 6-6:30am. The patient was admitted to the hospital. The shot was given at the facility. She received it at 3pm on 06Jan2021, First dose was on 16Dec2020.The caller relays she didn't know how aggressive the hospital will be for the patient. She was a full code when left and now a DNR and is unresponsive. The patient will be going on hospice care. The causality was reported as related. The outcome of the events was not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tachycardia, shortness of breath, congestion, unresponsive, and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. The patient's pre-existing medical condition of cardiac failure congestive, hypertension, cardiac murmur are confounding factors. 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 RA, IEC, as appropriate.

At approximately 12:15 pm the resident had a brief unresponsive episode that resolved quickly. Her Vital signs were stable and her mentation was at baseline. Later that evening approximately 10 pm she had labored respirations, shortness of breath, lethargy with bilateral crackles, Oxygen desaturated to 76% on room air, tachycardia and hypotension. She expired at 6:30 a.m. the following day.

Hypertension, possibly associated with orthostasis and lack of sleep. At 11:45, patient reported dizziness when standing after receiving the vaccine. Manual BP of 160/100. Atypical pulse of 128 BPM. Patient was reseated and monitored, PCP was called.

Patient did not have any issues until 1/29/21 at around 8:40 AM (the day after vaccination). Her symptoms are: Pale, lethargic, hypotension, slurred speech, unable to verbalize, and weak. Her blood pressure was found to be 68/34. Pulse was 66, O2 93, and temperature was 98.6 degrees F. EMT was called and the resident was sent out. Hospital has been called and they are unknown what is going on and unsure if the resident will be admitted or not.

After sitting in the observation area for 15 minutes she was ambulating to leave the clinic when suddenly noted feelings of air hunger and pressure on her chest. Said she just "felt funny". Was taken to triage room where her O2 levels, pulse, and BP were monitored. O2 level 98-99%, Pulse 65-69 bpm, BP around 160/60. After being allowed to remove her mask and have some water she stated she felt better. Was monitored for 15-20 more minutes during which time BP remained around 160/60. Eventually stated that feeling of air hunger and chest pressure had resolved and she was allowed to leave the facility . No other symptoms noted. Felt fine the rest of the day. No other symptoms noted the following day.

Patient was found unresponsive on her kitchen floor about 9:45 AM on February 10, 2021 approximately 18 hours after receiving her first Covid-19 vaccination. Exact time of the event is unknown. She was known to get up between 6:30 and 7:30 AM. It appeared that she had not eaten breakfast nor taken any medication that morning. She was taken by ambulance to Medical Center where a CT scan showed an unrecoverable massive brain hemorrhage. She died at approximately 3:50 PM after the respirator was removed. She was sent to the local Medical Examiner afterwards.

assessed patient, auscultated normal lung sounds, chest tightness described from patient. Cough observed which was not normal for patient then 911 was called. paramedics arrived on scene, further assessed patient. Patient taken on stretcher by paramedics

96 yo F presents with with thrombocytopenia, suspected ITP. Pt had the Pfizer COVID vaccine approx 4 weeks ago. She initially developed an itchy rash on her lower/mid back. Over the last 2 weeks, she also developed increased bruising/purpura on her flank/hip and LEs. Her son, a radiologist, came to town late last week and noted that in addition to bruising, she had what appeared to be petechiae on her LEs. Son had her skip her 2nd dose of vaccine (scheduled for Friday) and took pt to PCP for blood work. CBC apparently showed PLT of 9k so pt went to ER. Repeat PLT was 11k and pt was admitted overnight. She received dex 40 mg IV x 1 on 2/20/21. Repeat PLT today is 11k. Family reports she had normal blood work including CBC about 1 year ago. No active bleeding. No change in mental status No recent viral or bacterial infection. She otherwise feels well. No history of blood disorders or ITP. No history of autoimmune disease.

Vaccine induced severe ITP; This is a spontaneous report from a contactable Other HCP. A 95-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration in right arm on 29Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included rectal cancer from 1998 (S/P AP resection, cured), Abdomino-perineal resection of rectum from an unknown date, Sulfonamide allergy. No Covid prior vaccination. There were no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not receive other medications in two week. The patient previously took amikacin sulfate (NOVACIN) and experienced drug allergy. In 2021, patient developed multiple ecchymotic/purpuric skin lesions on extremeties and trunk 1-2 weeks after vaccination. Platelet count 9k. No anemia. Normal WBC. Oncologist diagnosis vaccine induced severe ITP (Idiopathic thrombocytopenic purpura). Admitted to Hospital 20Feb2021. Ongoing treatment. The patient was hospitalized for the events from 20Feb2021 to 25Feb2021 for 5 days hospitalisation. No Covid tested post vaccination. AES resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event)]. The patient underwent lab tests and procedures which included platelet count: 9k in 2021, white blood cell count: normal in 2021. Therapeutic measures were taken as a result of events (IV Decadron, IVIG). The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of idiopathic thrombocytopenic purpura due to temporal relationship. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Headache. More likely due to high BP than vaccine, but had headache for 3 days after first vaccine dose.

heart attack; became ill; I became nauseous; vomiting; dry heaves; dizzy; tingling in my face and right hand; right hand didn't feel like I could get up on my own; This is a spontaneous report from a contactable consumer. A 95-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 10Feb2021 10:15 at SINGLE DOSE in left arm for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) with lot number: EL3249 on 20Jan2021 in right arm. After receiving the 2nd dose on 10Feb2021, the patient became ill on 11Feb2021, while sitting on the toilet, she became nauseous and vomiting repeatedly even dry heaves also then became dizzy and felt a tingling in my face and right hand didn't feel like the patient could get up on her own so the patient's son and daughter assisted her to her bed. She didn't know what was wrong and her daughter thought it was a side effect of the vaccine and called the nurse on call. After arriving at the emergency and was examined the patient was told she was being kept for observation since she had just had the vaccine. The patient was later told she also had a mild heart attack and to her knowledge I never had any heart issues. She could then no longer use her walker to walk because she couldn't bear weight on her right hand. She was hospitalized for 8 days and transferred to rehab and I'm still in rehab. The events were assessed as serious (hospitalized and disability). The outcome of the events was not recovered. The patient received treatment for the events.

Friday the 26th Headache, fever of 100, and extremely runny nose all day Monday the 29th extreme tiredness all day, late afternoon spike in blood pressure (169/90)

Brain bleeding; This is a spontaneous report from a contactable consumer. A 95-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Right on 19Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Feb2021 for covid-19 immunization (lot number: EN6198; location: Right arm) The patient experienced brain bleeding on 21Mar2021 19:30. The patient was hospitalized for brain bleeding for 11 days on an unspecified date. The event was also assessed as life-threatening by the reporter. The patient underwent lab tests and procedures which included nasal swab: unknown on an unspecified date. Treatment for the event was reported as unknown. Outcome of the event was not recovered.

02/20/21 5 days later after shot started reporting complaints. Hospital Visit with chest pains and confusion. 03/07-03/14 2021 hospital stay with encephalopathy, delirium?s, confusion. 03/20/-03/29 2021 hospital stay with hallucinations , staring and continued decline in health.

Patient presented after falling on February 5 with injury to her scalp. She apparently also fell on 2/4/21. Family was uncertain as to whether patient loss consciousness. According to family, patient has been weak over the last day or 2 with no other complaints aside from some diarrhea. EMS was notified PM Feb 5, and the patient was found to have atrial fibrillation with elevated heart rate to the 160s and hypoxic to the low 80% range on room air. She had a low-grade temperature and elevated respiratory rate according to EMS. Evaluation in the ED demonstrated bilateral chest infiltrates on chest x-ray (right greater than left), elevated heart rate with atrial fibrillation, and back pain. Imaging demonstrated a T11 compression fracture (possibly new), elevated pro-calcitonin (2.80 ng/mL) and elevated troponin (1.45 ng/mL). Her venous blood gas showed mild hypoxemia (7.39/25/41/33/57), and head CT did not show acute changes and her cervical CT was negative for fracture. Pelvic x-ray did not show fracture. She was covid positive. Admitted for acute hypoxemic respiratory failure and severe sepsis secondary to COVID-19 pneumonia and acute metabolic encephalopathy. Received 3 days of remdesivir and 4 days of IV dexamethasone. Also ceftriaxone was given 4 days for possible UTI. Goal of care switched to inpatient hospice on 2/8/21.

Presented to ED with UTI symptoms with apparent septicemia. COVID-19 test upon hospital admission was (+). Patient had low O2 sats on RA at 88%. She also reported chills, fever and myalgias and cough. Denied SOB.

This 95 year old female received the Pfizer Covid shot on 2/20/21 and went to the ED on 3/16/21 and was admitted on 3/16/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified

VS Prior to vaccine- BP 112/74, Pulse 86, Resp 16, 99% RS. 12:05-Patient received her covid-19 vaccine and went back to waiting room. Her son brought her back and said "Something isn't right". LVN, was in the room with patient. Patient was unresponsive at this time. One sternal rub was attempted without response. Code blue was called. 2L NC placed, pulse ox 93% after placement. IV placed R AC with NS running to gravity per RN. Patient slightly responded to 2nd sternal rub. 2nd IV was placed L AC by RN. Dr. S and Dr. T was present in the room along with the code team. Patient started to come to semiconsciously when EMS arrived. At this time vitals were starting to stabilize. Patient left in route to hospital. BP 96/50, Pulse 68, 93% o2 sat, 141 blood sugar when patient left per ambulance.

On May 14, 2021, at 9:30 p.m., patient was found on the floor by caretakers who had her taken to the Emergency Dept. She exhibited signs of a stroke; her left side was paralyzed. A CT scan of her brain was done, which showed a blood clot in her brain, which caused the stroke. She was taken to medical center, where she remains as of today, June 3, 2021. She remains paralyzed on her left side so she is unable to walk, or to use her left arm, or to swallow without aspirating food into her lungs. Potentially we have found a care facility and hope that she will be moved there within a few days. Of all the people I know, patient is the last person I would expect to have a stroke. She has always had good blood, a strong heart, strong bones, has never smoked or drank, has never been overweight, and has always worked hard and exercised daily. Her internal organs are all strong and well-functioning. She has had two CT scans of her brain within the last couple of years, the last one near the end of 2020, and they were both clear. These scans were done following falls which she took. She had the the COVID-19 on January 23 and February 17 of 2021 and had a stroke on May 14, 2021. There is no doubt in my mind that her stroke was caused by these injections. She will never recover from this event and will probably get pneumonia, which will bring about her death!

Patient came into the emergency department on 1/8/21 with an acute ischemic stroke with complete occlusion of her left MCA. She had acute and complete flaccid paresis of her right face, arm, and leg, complete aphasia, and neglect of the right side of her body. NIHSS of 27. Onset of deficit was between 6:30pm-7:10pm. She recieved her 1st COVID-19 vaccine dose that morning at 10:31am.

Has underlying dementia and often with difficulty eating. 1 week after immunization she developed a stroke with left sided weakness and difficulty swallowing. Comfort measures instituted. Not sure if this is related to the vaccine, but thought I should report

presented to ED 1/9/21 with abdominal pain, progressive worsening weakness and fatigue and new onset A fib with RVR likely due to hypertensive urgency . Patient progressed clinically with severe hypoxia and transferred to ICU and started on BiPAP; progressive decline with decreased urinary output with uremia likely secondary to sepsis. Concern with patient worsening clinical decline, palliative care had been consulted on end of life care. Patient expired 1/17/21

Patient complaint of dull chest pain after leaving clinic room and walking to main lobby. Unable to pinpoint exact location of chest pain and unable to report exact duration of chest pain. When I arrived to the patient, she stated her chest pain had gone away. Vitals taken at 2:16 pm: BP-132/71, HR 71, 94% O2. Patient is on 2 Liters continuous oxygen via nasal cannula. Patient states she is taking "15 heart medications" and follows up routinely with cardiologist. Patient not experiencing difficulty breathing, and having no difficulty speaking with me. Vitals taken again at 2:22 pm: BP-140/74, HR 70, 93% O2. Patient was monitored 10 minutes after last set of vitals where she continued to deny chest pain or difficulty breathing. Care was then turned over to assistant living staff to ensure patient got home safely.

Patient began to demonstrate a cough the evening of 1/5/2021, after receiving the COVID-19 vaccine earlier in the afternoon. A rapid COVID-19 test was performed and was positive. She began to demonstrate shortness of breath with exertion on 1/7/21, and lethargy on 1/12/21. Appetite and oral intake began to decline on 1/12/21, and Oxygen saturation dropped on 1/16/21 to 82%, and oxygen was initiated at 3L per nasal cannula. On 1/19/21 at 0414 patient was unresponsive and without vital signs. Orders were for DNR, and CPR was not initiated.

Temp of 100.1 and unproductive cough on 1/17; temp of 100.4 1/28; O2 desaturation 88% on RA 1/28; Diagnosed with Covid-19 on 1/18/2021 Patient passed away on 1/29/2021

Excerpt taken from patient's medical record notes. Recreational Therapist was in room with patient who was at baseline mentation at that time, and was getting patient a cup of tea. Rec Therapist observed patient to "all of a sudden slouch down toward left side" and became unresponsive. Therapist called for help, and Registered Nurse (RN) and Certified Nurse Aide (CNA) came into room. Patient was initially non-responsive and profusely sweating and hot to touch. Vitals were taken (see below). The patient then slowly became responsive after approximately 4 minutes and was visibly nauseous and appeared like she was going to vomit, but ultimately did not. Patient was assisted into bed, APRN was called, order for vital signs to be taken every 4 hours for 72 hours, and Electrocardiogram (EKG) to be performed. EKG results were abnormal, indicative of infarct; APRN ordered transport to Emergency Department. Patient returned from Hospital ED at approximately 10:45 PM same day (1/28/21), with transfer paperwork documenting a Hospital diagnosis of "Syncope" without any additional lab results or any new medication or treatment orders in the documentation. Follow up the next day (1/29/21) by RN at the Nursing Facility--RN logged into the Hospital medical Charting system, only to find that there was no record whatsoever of the patient being in the Emergency Department on 1/28/21--no notes, no labs, no summary from a practitioner. Patient recovered and has resumed close-to-baseline activity and functioning.

There were no symptoms experienced on the first vaccination given on 1/14/2021. The second vaccination was given on 2/4/2021, the following day (2/5/2021) patient complained of fatigue and nauseau. In the evening she went into cardiac arrest and died.

1/30/2021 Admit Note: Patient presents to the ED complaining of chest discomfort. Patient has a history of hypertension, congestive heart failure, COPD, afib, and multiple other medical problems. Presented to the ED with some left-sided chest pain. She had an episode of chest pain when she received her first Covid vaccine a month ago and was thought to be related to a GI symptoms she had negative EKG at that time. She received her second dose of Covid vaccine couple days ago and was woken up at 4:00 this morning with a feeling of chest discomfort that she describes as a pressure sensation with no associated shortness of breath or cough or nausea or vomiting. (cont below)She states she was given aspirin and EMS was called but the chest discomfort is resolved by arrival to the ER after the aspirin. 2/2/21 Discharge Note: Chest pain did not appear to be cardiac in nature. Old CT scans that showed some chronic lung changes and also old rib fractures. The pain that she has seems to be consistent with either GERD or hiatal hernia.

The above info is available but it is as my mothers....She had a bad reaction ( very flu like for several days). I proceeded with second shot in February....she did not feel well, but just sorta didn't want to get up anymore. She slept more and more and more. Her appetite declined. I got her up and she was ravenous. She slept more and seemed in a lethargic way to take less and less interest. She was living independently and had been most of her life. We scheduled an internist report. She passed labs with flying colors....... when you are 96 they look at everything as remarkable ( will live for 10 more years). I also was not equating any of this with the vaccine. However, we could not ignore it any longer Saturday the 4-10-21. I took her to ER. She was lucid and walking with difficulty. I took her in by ambulance as she was just saying, "I'm so week!" I'm so whoozie! On Sunday they are talking immediate intensive rehab. Neurologist leave for 5 days and in next 48 hours she becomes 200% less. First delusional, then sleeps all day. He showed me an MRI that to a layperson looked like little hives all over the brain ( I had also gotten hives from somewhere on my skin that I originally equated with Covid but no one thought so. I have also had the two shots.) One week out I was looking at Hospic eand long term care placement. Yesterday they couldn't get a diagnosis for Hospice ( the person sent to sign her up). I thought what? After all these tests and maybe it is cardio, maybe it is exchemic strokes, they don't have a diagnosis because she hasn't changed much since 2017? We have to take this totally fine independent woman and in one week say, "She has Dementia?" It's possible but what caused it? It's not age......we live until we are 110. Yes, that MRI showed me little formations of clotting all over ( no major bleed if any in a lobe). Over the last week I have been looking at her health and how we just slowly went downhill. It's easy to blame a vaccine, but still..........I am saying that there were NO OTHER reasons other than she didn't seem to tolerate the shots well........first was acute, and the second was long term and slow...........

Congestive Heart Failure decline, AFib w/RVR, hospitalization, Respiratory decline, Cardiac decline, possible UTI, Hospice Care, continued decline, expired.

blood clot in her leg; blood clot in her leg; Cardiac arrest; Heart attack; This is a spontaneous report from a contactable consumer (patient's daughter). A 96-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 29Jan2021 (Lot Number: EL9265) as SINGLE DOSE for COVID-19 immunization. Medical history included blood clots in her legs from an unknown date and unknown if ongoing , diabetec, bone infection, surgery and anemic; all from an unknown date and unknown if ongoing; and a family history of gangrene from an unknown date and unknown if ongoing of her mother. Concomitant medications included apixaban (ELIQUIS) taken as blood thinner and furosemide (FUROSEMIDE) taken for an unspecified indication; both start and stop date were not reported. The patient previously had BNT162B2 (Lot Number: EL1283) dose 1 on 08Jan2021 for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was in the military facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, the patient died due to a heart attack and cardiac arrest. The patient developed a blood clot in her leg and had to have her leg taken off. The date of surgery was 05Feb2021, not early Mar2021 like was originally stated at the hospital. The patient was admitted either on 01Feb2021 or 02Feb2021 and discharged on 23Feb2021. They had a bunch of bad weather and then they put the patient in the nursing facility for about a month and when she was brought home she had a heart attack and died due to cardiac arrest. She doesn't know about the blood clot and this being related to the COVID vaccines but the patient had surgery a week after she had her second shot. The heart attack was on 15Mar2021. The patient had a history of blood clots in her legs before and she had problems with that so that might of made it worse but she doesn't know for sure. The patient died on 15Mar2021. An autopsy was not performed. The outcome of the event blood clot in her leg was unknown. No follow-up attempts are possible; information about lot/batch number has been obtained.; Reported Cause(s) of Death: heart attack; cardiac arrest

heart arrhythmia; This is a spontaneous report from a contactable consumer (calling on behalf of his mother). A 96-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20May2021 (Lot number was not reported) as single dose (at age of 96-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced heart arrhythmia. Reporter stated that patient was living like a hermit for 15 months. She had her first dose last 20May2021 after getting that vaccine she experienced heart arrhythmia. Reporter was asking if there were reports specific to heart arrhythmia and what recommendation there is if her mother can still get her second dose of the vaccine or choose to wait. Reporter was asking for the efficacy of only a single dose of the vaccine and was asking for information on delaying the second dose. The outcome of the event was unknown. Information regarding the Lot/Batch number has been requested.

My mother collapsed the morning after her second shot.; She was non responsive; blood pressure was very high; limp, could not walk; squeezing sensation around head; Fatigue; This is a spontaneous report received from a contactable consumer (Patient). A 96-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EWo191) via an unspecified route of administration, administered in Arm Left on 09Jun2021 at 01:00 PM as single dose for covid-19 immunisation at Pharmacy/drug store. Medical history included renal insufficiency and Grave's Disease. Patient had no known allergies. The patient's concomitant medications were not reported but she received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19, since the vaccination. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot number: ewo176) via an unspecified route of administration, administered in Left arm on an unspecified date in May2021 at 01:00 PM covid-19 immunisation. On 10Jun2021 at 09:00, the patient collapsed the morning after her second shot, she was nonresponsive, limp, could not walk, blood pressure was very high, squeezing sensation around head (stated did not know what year it was). Ambulance was called and she was hospitalized for two days. CT scans and blood work were normal. ER (emergency room) Doctor and floor Doctor both said it was an extreme reaction to the second dose of the vaccine. Fatigue, unresponsive episodes continued for two days after she was released to home. The patient underwent lab tests and procedures which included blood pressure measurement: high, blood test: normal, computerised tomogram: normal, echocardiogram: unknown, urine analysis: unknown. Therapeutic measures were taken as a result adverse event. The outcome of events was recovering. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on close temporal relationship the causal role of the vaccine cannot be excluded for the reported events. Renal insufficiency and graves disease can be contributory to event

Vertigo; she fell; On first day she was about to faint, second day she was about to faint again; Pain went away; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 07Jul2021, this case now contains all required information to be considered valid. This is a spontaneous report from contactable consumers from a Pfizer-sponsored program. A 96-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration on 22Jan2021 (at the age of 96-years-old) at dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 22Jan2021, on the first day, the patient was about to faint and on the second day, she was about to faint again; then on 26Jan2021, the patient fell. On 29Jan2021, they took the patient to an urgent care. CT of lumbar spine and pelvis performed on 04Feb2021 and thoracic spine and upper middle back scan performed on 10Feb2021 showed that nothing was broken. Therapeutic measures were taken as a result of the events. The patient had to have a caregiver because of her fall. Her second dose was due on 24Feb2021 and the reporter wanted to know if the patient should get it despite her current situation. On 13Mar2021, the patient started feeling better and the pain, which started from an unspecified date in 2021, went away. The event fall required emergency room visit but did not require hospital admission. The last week of Jun2021, the patient started having vertigo. The outcome of the event vertigo was unknown, recovered on 13Mar2021 for pain, and recovered on an unspecified date in 2021 for all other events.

Every time my mother blows her nose or coughs up phlegm there is a lot of blood; Every time my mother blows her nose or coughs up phlegm there is a lot of blood; This is a spontaneous report from a contactable consumer (patient's daughter). A 97-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 as a single dose for COVID-19 immunization, lot number: EL0142. Medical history and concomitant medications were reported as none. Patient's daughter reported severe problems with the vaccine. Every time patient blows her nose or coughs up phlegm there is a lot of blood, onset date unknown. No treatment received for the events. Outcome of the events was unknown.

Systemic: Cardiac Disorder (diagnosed by MD), Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Fainting-Severe, Systemic: hyporthyroidism vitmain d defiency; symptoms lasted 1 day

Already reported immediate severe weakness, lethargy, withdrawal, delirium. Now adding 4 days later ... hypotension, nausea, vomiting, diarrhea, cramps, chest pain. ER visit and 2 day hospitalization. Abdominal CT indicated intestinal inflammation in the area of the Cecum. One week of antibiotics.

Couldn't speak, slurring words, stuttering, couldn't formulate a sentence; stroke; This is a spontaneous report from a contactable consumer. A 97-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 14:15 at single dose for covid-19 immunization. Medical history included ongoing atrial fibrillation(A-flib), took medication for that. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), rosuvastatin calcium (CRESTOR). Additional vaccines administered on same date of pfizer suspect reported as no. Prior vaccinations within 4 weeks, AES follow prior vaccinations and family medical history all reported as no. The patient got her first dose on 16Jan2021 and that evening she began to have a stroke. The patient was on blood thinners (apixaban(ELIQUIS) and questor). Event reported as "Couldn't speak, slurring words, stuttering, couldn't formulate a sentence" with onset date 16Jan2021. Event was serious as hospitalization from 17Jan2021 to 18Jan2021. The outcome of the events was not recovered/not resolved. Patient was caller's mother. Four hours later, patient couldn't speak and was slurring words. Ambulance was called, vitals were checked, and patient was told she was ok. Next morning patient was the same. Ambulance was called again and patient had a stroke. Caller stated the stroke was very coincidental. Patient had the COVID-19 Vaccine at about 2PM. Patient had A-fib. Stroke affected patient's speech, but not terribly. Patient was on a blood thinner at the time of the report because of MRI and CT scan results. The patient was taking acetylsalicylic acid (BABY ASPIRIN), but that was taken away at time of the report. The patient was on rosuvastatin calcium (CRESTOR) 0.5 at time of the report. Next appointment for second COVID-19 Vaccine was 06Feb2021. Caller was concerned. Patient never had a stroke before. The reporter wanted to know if this had been previously reported. Saturday night was when patient's speech began slurring. The patient had the Pfizer COVID-19 Vaccine that afternoon. EMS didn't take patient to the hospital on Saturday night, just took vitals and left. Patient's speech was going in and out. Caller reached out to patient Sunday morning and patient was having the same speech issues. Patient was stuttering and couldn't formulate a sentence. Ambulance was called and patient was transported to (health center). CT scan and MRI showed patient had a stroke in the area of the brain that affect speech. Patient had an echocardiogram. Clarified patient's speech symptoms began on Saturday, 16Jan2021.   Information of lot/batch number has been requested.

Joint pain in arms and back, increased pulse, (120-135) slight fever 100.4 - my temperature is usually around 97, the next morning temperature was 94.4. cough. These symptoms lasted, off and on for about a week. I had fever once. Feeling limp as a rag. No energy.

PRESENTED TO HOSPITAL WITH MULTIPLE SYNCOPAL EPISODES THROUGHOUT THE DAY @APPROX 7PM 2/24/21. HAD SEVERAL EPISODES OF ASYSTOLE. CURRENTLY COMPLETE HEART BLOCK. PT HAS DNR AND IS IN HOSPITAL. INFORMATIO PROVIDED BY RN

within 24 hours after her second injection she developed chills, had a syncopal episode and had, difficulty breathing. this progressed over the next day when she had a second syncopal episode and her dyspnea and confusion worsened EMT was called and she was brought to the hospital. she was in flash pulmonary edema and with her history of severe aortic stenosis she was admitted to the cardiac icu. she had no prior history up to that time of pulmonary edema and was functioning without distress in her home. she had a history of covid in early april, manifesting primarily as severe confusion, from which she recovered.

In ED on 2/25/21 Chief complaint: Patient's daughter present at bedside stating patient was not vocalizing this morning when she woke up. Patient's daughter was talking to her and she would orient to her but not answer any of her questions. EMS called and by the time they arrived patient was acting her normal self. Daughter states she has had a very difficult time managing patient's behaviors over the last several weeks and it has been getting more difficult. Daughter states that over the last several weeks her behaviors have been worsening and been more difficult to deal with. These include her getting up at night and sundowning as well as yelling and screaming during the day. Daughter states that she gets in the shouting matches with the patient during the day. Daughter breaks down and starts to cry when discussing that she thinks her mother will need long-term placement as she is having a difficult time dealing with her behaviors. Of note patient did receive second dose of Covid vaccine yesterday. -Patient has not been complaining of any symptoms over the last several days and daughter has not noticed cough or congestion or other signs of URI/illness -No focal neurologic deficits on exam -Received 1L IV NS in ED 2/26/21 Covid positive, incidental finding ? tested so she could go to nursing facility -Patient asymptomatic -Vital signs stable, afebrile -She does not need treatment at this time -She will need a repeat Covid test 14 days after the original Covid test prior to going to SNF -Plan- discharge to skilled nursing facility Discharge summary Principal Problem: Comfort measures only status Active Problems: Chronic atrial fibrillation Essential hypertension Dementia with behavioral disturbance Recurrent falls Dysphagia COVID-19 Resolved Problems: Cough with hemoptysis Leukocytosis Dehydration Inadequate oral intake Patient is a 97-year-old female with a past medical history of dementia, likely combined vascular/Alzheimer's, hypertension, chronic A. Fib, who presented to the ED on 2/25/2021 due to behavioral disturbance as well as need for long-term care placement due to progressive dementia. She did have an incidental positive Covid test on 2/26/2021 and was planned for discharge to COVID recovery ward of SNF. She did not require medication or oxygen treatment for COIVD-19. She developed tachycardia/tachypnea and cough later productive for blood after suctioning attempts overnight on 2/28-3/1, which did not recur. Unfortunately, patient's overall function declined after, and she was refusing/unable to eat or drink. She was transitioned to comfort care status on 03/03/2021. She eventually slipped into persistent sleep with lack of responsiveness on 3/4/2021. Comfort care was provided. She had decreased urinary utput and respiratory function indicating expected progression. She was noted to not have a heart rate on 03/08/2021. Auscultation did not reveal any breath sounds or heart sounds; unable to palpate pulse; no pupillary response to light was seen; and patient did not respond to painful stimuli. Death was pronounced on 03/08/2021, 02:58am. Deceased 3/8/21

Developed multiple dvt and pe one week after vaccine. Patient started on heparin drip the bridged to coumidin then switched to xarelto.

She has not been feeling herself; Wheezing; Mild tachycardia; Oxygen saturation drop; This is a spontaneous report from a contactable nurse (patient's son) via Pfizer sponsored program. A 97-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 97 years of age), via an unspecified route of administration, administered in arm right on 18Mar2021 10:45 (Batch/Lot Number: EP6955) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included compression fracture (fell in the driveway) from Apr2010 to an unknown date, ongoing hypertension for a long time sine 1980s and has gotten less with age; diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. The patient has no known drug allergies and no known food allergies. Family history included cardiovascular, cholesterol, blood pressure, but nothing relevant to her situation. She was never a cigarette smoker and she had no history of smoking. Concomitant medication included atenolol taken for blood pressure from an unspecified start date and ongoing. The patient previously took atenolol for hypertension and experienced dizzy and sometimes her pulse will get a little on the higher side. She had no history of previous immunization with the Pfizer vaccine considered as suspect. She had no prior vaccinations within four weeks prior to the first administration date of the covid vaccine. She did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not receive any recent vaccines for any other conditions prior to the event/s being reported. Patient received the first dose of the Pfizer COVID-19 vaccine 18Mar2021 and has yet to get the second dose. The patient experienced wheezing in the morning, mild tachycardia and Oxygen saturation drop on 15Apr2021. The patient got her first dose in Mar2021 and since then she had not been feeling herself so they waited on getting her second dose. The reporter asked if the patient can get her second dose or does she have to start all over. The patient is in a hospice, and she was at home; she can get out of the house rarely. The first dose was on 18Mar2021 and she tolerated it well. It was mentioned that she was kept in a tight bubble and anyone that comes into contact with her has to get the shot. She did about a month after her first dose experience wheezing. She never had wheezing before and she had to have oxygen, which she never had to use before. He said they had to do intermittent oxygen. She was doing ok now, and he was not sure if a month after the first dose was some kind of a reaction. The patient's first dose was on 18Mar2021 and has yet to get the second dose. He said a little less than a month later she had wheezing and that she never had wheezing and he never heard her wheezing. He said it was almost four weeks after the date of her vaccination. He said they put her on oxygen at home because her O2 saturation dropped. She was in the high 80's and she was usually in the high 90's. He said in mid Apr2021 she was in the 80's. He said the oxygen was intermittent now and they use 1L. He said he wanted to make sure her oxygen saturation stays good and that it was not life threatening. He said given her age she was dropping O2 saturations in the 80's and she was never in the 80's. She did not have her second dose and it was due 08Apr2021. He said she was doing ok, no wheezing at the time. He said with her age and hospice, he heard things on TV that there were lots of problems with the second dose any of the vaccines so they watch close. He said any contact with her is vaccinated and she stays in a tight bubble at home. He says they are being very conservative. He says she got the vaccine around 10:45am. It was mentioned that the patient was experiencing mild tachycardia. She was in the 90's or low 100's but was not sure if it was related to the wheezing or if it was the dose. He said he noticed it the first time on the same day he noticed the wheezing. He said that on 15Apr2021 her heart rate was 146 when checking oxygen saturation. He said that his mother's blood pressure was usually 115/75. He said her hypertension has gotten less with age. She has had no blood work done because of COVID or the pandemic. He says no pcp visits, only telemedicine visits. He said she has had no labs done in a long time but that they monitor every day and as long as she's eating, etc. Therapeutic measure was taken as a result of wheezing and Oxygen saturation drop wherein she was given intermittent oxygen 1L ordered by the hospice nurse. The caller says the used no inhaler or nebulizer because the oxygen brought her saturation up. He says they also gave her some cough medicine. He does not remember the name of the cough medicine. He says it was just some DM, dextromethorphan, from . The events did not result from Emergency Department, patient was not hospitalized, not admitted to an Intensive Care Unit. The patient was recovering from the events as she was getting better. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees, and Investigators, as appropriate.

Pfizer vaccine, she presents with tremors, hypertension, tachycardia. Pt has a h/o Afib, and she tells me that she has had tremors in her RLE x6 months or so, but that it worsened today. Denies precipitating events. She also had SBPs up to 170's (150's/90's on my interview) and is tachy to 140's in sinus tach. Denies any caffeine today or anxiety or behavioral contributors today, no pain or other stimuli. Pt admits she is feeling jittery when she talks with me, and that taking deep breaths slows her heart rate to 70's-80's. Patient has notable history of cHF with associated LE edema in the past and should strongly be considered as part of this ADE assessment.

I am the discharging physician and did not admit her but based off the information at admit: the patient received her Pfizer vaccine and developed nausea during her observation time but it was not significant enough to cause concern for the family. They took her home in good spirits and she appeared to be doing well until the evening when she became unresponsive. She developed high fevers and came to the ER with low normal O2 saturations and evidence of sepsis. Blood work showed a markedly elevated white count and an elevated lactic acid of 8 along with an elevated renal function and cardiac enzymes without EKG changes (multiorgan failure). Her COVID test was negative. Blood and urine cultures were negative. A CT scan of the abdomen demonstrated no acute findings but likely chronic fecal impaction. CT Head was negative for bleed or stroke. At this time is is unclear as to what was the cause of her symptoms but we believe it was presumed bacterial sepsis but this diagnosis is in question as all her cultures were unremarkable. The family opted on comfort measures rather than aggressive intervention and she was sent home with hospice. Since it occurred so closely after receiving the vaccine I think it was worthwhile to bring it to your attention.

Minor arm pain on 2nd day of each vaccine Diarrhea 3 days after 2nd vaccine Massive heart attack (left ventricle) 8 days (2/24/21) after vaccine Home hospice 3:30pm 2/24/21 Stopped breathing 5:45 am, pronounced dead at 8:22 am on 2/25/21

Pt had worsening altered mental status, tachypnea, and low-grade fever on 1/13/21. Pt considered terminal status previously and comfort-focus care pursued. Suspected pneumonia vs. TIA/CVA. PO meds D/C'ed as patient could no longer swallow.

1/24/20211 unresponsive, sent to Hospital. Admitted with diagnosis: Acute Ischemic left MCA stroke. 1/26/2021 Transferred to Hospice care. 01/30/2021 died. I don't believe the hospital was aware of her vaccination date as it is not recorded in her records, therefore I assume that a previous VAERS report has not been submitted. My relationship to the patient is that I am her daughter.

This 98 year old female was admitted from medical center this date to this facility due to dehydration and deconditioning. Pt has ribs 6 and 7 Fx on left side with pleural effusion.

Pt. received the Covid-19 vaccine and reported symptoms of dizziness, weakness and stated "my chest hurts" within approximately 10 minutes after receiving the vaccine Vitals signs taken as recorded below 1620: BP 155/80, HR 102, O2 95% 1623: 147/59, HR 98, O2 96% 1627 148/59, HR 97, O2 97% At 1628 EMS was called because the patient continued to report chest pressure and "feeling tired". At 1632 EMS arrived and was taken to the hospital. VS at time of EMS arrival: 159/50, HR 79, O2 98%

patient received the second dose of the Pfizer vaccine at 1618, ten minutes post administration, patient started to feel weakness, dizziness, chest pain

Pt developed red, swelled, warm, painful RLE at lower leg/ankle/foot less than 24 hours, near 12-18 hours after 2nd dose.

Patient is a 99yr old female who got a covid vaccine in the afternoon of 1/10/21 and woke up in the morning of 1/11/21 with altered mental status, weakness, and dysarthria. She was taken from her assisted living facility to the hospital and MRI showed a small stroke in the right medial thalamus. She was also found to have new onset atrial fibrillation. She was treated appropriately for both conditions and discharged to a skilled nursing facility on 1/13/21.

presented to the ED with substernal chest pain with right to left side radiation and continuous waxing and waning right sided abdominal pain with back radiation consistent with previous episode of acute cholecystitis; still admitted

on 1/26/21 Found laying on Bathroom Floor in Bedroom Apt. Complaint of Right Shoulder paiN bleeding (unknown origin) then discovered origin HANd/FiNgers. (Head on Floor towARds WALL) SeNT TO ER 1/26/21, Admitted 1/26/21 Diagnosis: AoRtic STENOSIS

Individual collapsed 9 days post-vaccination with no known reason. Despite being healthy prior to vaccination, individual's condition deteriorated rapidly. Individual passed away on 1-17-2021.

Developed acute facial droop and slurred speech 2h after 1st dose of the vaccine on 2/17, found with R MCA stroke. Then became unresponsive on 2/27 and was found with an acute L MCA stroke. Was transferred from another hospital, was not a candidate for intervention, and was made comfort and died on 2/28

she was dying as her blood pressure dropped to 70/40 and to come for a last visit; This is a spontaneous report from a contactable consumer. A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization. Medical history included COVID in Dec2020, urinary tract infection (UTI), dehydration and Covid sickness (vomiting) (was treated earlier in month for UTI and dehydration from the Covid sickness (vomiting)). Known allergies: no. The patient's concomitant medications were not reported. After testing positive in mid December to COVID and being declared Covid free on 30Dec by the nursing staff and in good health, with normal vitals and oxygen levels, the patient was given a vaccination on 02Jan2021. In the early evening the patient's blood pressure dropped to 70/40 and the reporter was told to come for a last visit. The patient was sleeping comfortably. She did not wake up when spoke with her. No one expected her to make it through the night. The next morning she work up, ate breakfast, watched TV, got IVs and oxygen and her vitals improved significantly. Lab tests and procedures included blood pressure: 70/40 on 02Jan2021, oxygen levels: normal, COVID test: positive in Dec2020 (testing positive in mid December to COVID and being declare Covid free on 30Dec), vitals: normal; improved significantly. Facility where the most recent COVID-19 vaccine was administered: Nursing Home/Senior Living Facility. If the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: Yes. Since the vaccination, has the patient been tested for COVID-19: No. AE resulted in: Life threatening illness (immediate risk of death from the event). Serious: Yes. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: Yes. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No. Information about lot/batch number has been requested.

episodes of 4.5 seconds with non pulse; she experienced a basal artery blood clot stroke; lightheaded; This is a spontaneous report from a contactable consumer (patient's son). A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jan2021 14:30 (at the age of 100years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. The patient's medical history was not reported. Concomitant medication included furosemide taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had medical issues starting within hours of the first dose of Covid vaccine. Prior, the patient was in independent living, no medications (as reported), walking about 1/2 daily and completely lucid. Immediately thereafter (after the vaccine, 11Jan2021 16:00), she experienced lightheaded, a hospital stay, and episodes of 4.5 seconds with non-pulse. A pacemaker was installed. During rehab, the patient experienced a basal artery blood clot stroke. The patient is still in rehab. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized on an unspecified date for 8 days. Treatment received included pacemaker, numerous medicines (e.g. AFIB). The patient had Covid test post vaccination: Nasal Swab on 15Jan2021 with negative result. The outcome of events was recovering. Information about lot/batch number has been requested.

Received first dose of Pfizer vaccine in left deltoid on 4/8/21 at 7:30 am. At 10:00 am, she called her niece and complained of extreme fatigue. At 12:00 pm, she complained of worsening fatigue and blurry vision. At 3:40 pm, she complained of loss of appetite but denied fever and chills. The niece was unable to reach her by phone after 4 pm, so she came over to the decedent?s residence at 6:15 pm to check on her. The niece found her lying face up in bed ?gasping for air.? She then became unresponsive and EMS was called. The decedent was pronounced at 8:11 pm after unsuccessful resuscitative efforts. Autopsy showed hypertensive and atherosclerotic cardiovascular disease with marked partially calcific coronary atherosclerosis; marked pulmonary edema; and pleural effusions. The brain was saved for neuropathology given the history of blurry vision.

Pfizer vaccine Difficulty breathing, delusions, hallucinations, combative, anger, sky rocketing blood pressure lack of motor control, weakness, inability to take care of herself, confusion to the extent of dementia. Non of these symptoms prior to vaccine

Resident reported feeling nauseous and wanted to vomit and did not. Had an episode of diarrhea and needed assistance as she was unable to make it to the restroom (this is not her normal) and was noted to have extremity tremors. Legs and arms were noted to be shaking and resident had c/o not being able to walk steady because of it. Resident was assisted with a shower and after relaxed with no further complaints. Was treated with PRNs for nausea with 20ml of Geri-Lanta Suspension and diarrhea with 15ml of Loperamide HCl Suspension . Pulse was noted at 101 and all other vitals WNL. Resident reported she had not consumed much fluids during the day. Was instructed on hydration and fluids were provided. Resident per post COVID-19 Vaccination protocol was administered PCR COVID test with NEGATIVE results and placed "under evaluation" status and placed in "Special Droplet/Contact Precautions." Resident reports today "feeling good" and has no further noted or reported episodes of diarrhea, nausea or extremity tremors or changes in her gait.

Patient 101 years old, nursing home resident, received vaccine 1/11, on 1/13 found on floor without obvious trauma, unresponsive. Brought to ED and was bradycardic, hypotensive, hypothermic and refractory to aggressive medical management. No obvious cause of death found on exam or labs, cxr. Unknown if event could be related to vaccine or not. Medical Examiner accepted case although initially unknown that patient had recently received vaccine. ME updated with that information today as soon as discovered.

passed away shortly after her vaccine; started dealing with signs that are common with a stroke; developed swelling in her arms; This is a spontaneous report from a contactable consumer report for grandmother. A 101-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EM9809) via an unspecified route of administration in left arm on 08Feb2021 04:30 AM at single dose for covid-19 immunisation. Medical history included elderly. No covid prior vaccination. No other vaccine in four weeks; No other medications in two weeks. On 12Feb2021 12:00 AM, patient passed away shortly after her vaccine. She started dealing with signs that are common with a stroke. Event considered Life threatening illness (immediate risk of death from the event). She also developed swelling in her arms. No treatment received, patient not recovered from stroke and swelling arm. The patient died on 12Feb2021. No covid tested post vaccination. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: passed away shortly after her vaccine

Stroke; sitting on the floor totally disoriented; Cardiac arrest; This is a spontaneous report from a contactable consumer (patient's Daughter). A 101-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration at the age of 101-year-old on 03Mar2021 at single dose for covid-19 immunisation. Medical history included glaucoma, blood pressure high, Mini stroke, her blindness was an infarct to her optic nerve, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, and obesity. Family history included Patient's sister got the vaccination and either 3 or 5 days later she passed away. There was none history of all previous immunization with the Pfizer vaccine considered as suspect. Concomitant medication included metoprolol taken for high blood pressure; levothyroxine; amlodipine taken for high blood pressure; sertraline to keep her spirits up because she is old and blind; latanoprost (XALATAN); dorzolamide hydrochloride, timolol maleate (COSOPT); acetylsalicylic acid (BABY ASPIRIN); calcium (CALCIUM); vitamin C [ASCORBIC ACID]; tocopherol (VITAMIN E). Prior Vaccinations (within 4 weeks), there was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). The patient received the Flu shot every year and patient also received the shingles shot and the pneumonia shot. Reporter stated patient had lunch and was sitting in the chair so it was probably somewhere between 12 and 3pm on 09Mar2021 when she had her stroke. Reporter states when she got back home patient was on the floor totally disoriented. Above events results in Emergency Room and patient was hospitalized from 10Mar2021 to 12 Mar2021. Reporter stated that patient died in her sleep so early in the morning probably between 3am and 6am on 06Jun2021. Reported cause of death was cardiac arrest. Reporter was calling about the Pfizer COVID vaccination. Reporter was calling on behalf of her mother. Reporter believed that her mother had a reaction to the first shot. Reporter stated that her mother had a stroke 6 days after receiving the first Pfizer COVID vaccination and has since passed away. Reporter thought this was a contributing factor. Reporter states that her mother was 101 years old but was an incredibly lucid and healthy individual. Reporter states that her mother used to be 5 foot 1 inch but she was probably 4 foot 11 inches at the time of this event (09Mar2021). Reporter states at the time of this event her mother probably weighed about 133 pounds. Reporter states that she came home on 09Mar2021 and found her mother on the floor. She took her mom to the hospital on 10Mar2021 and she was diagnosed with a stroke. Her mother was hospitalized 10Mar2021 through 12Mar2021. Reporter stated that her mother went to rehab after being discharged from the hospital. Stated that her mother never came back home. Reporter states that her mother lived with her. Reporter states she looked at her labs on 01Jun2021, her labs were always good. She stated that her mother also had a cat scan with contrast in 2021, no further details provided. Reporter states that she was not saying that this product caused her death but the timing was very suspicious. The patient underwent lab tests included Fasting blood glucose: 99 on 01Jun2021, cat scan with contrast with unknown results in 2021. The outcome of events was fatal. The patient died on 06Jun2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Stroke; sitting on the floor totally disoriented; Cardiac arrest

101 Y year old female with PMH significant for hypertension, CKD, hyperlipidemia, COVID + on 7/8/21 (reportedly got 2 doses of vaccine, though only have 1 documented in EMR) who presents with COVID pneumonia. ý Pt went to out of town for July 4th weekend. COVID + on 7/8/21. Housemate noticed pt seemed sicker upon returning with more fatigue, sleeping more, sinus congestion, intermittent cough. Denies any fevers, chills, chest pain, sob, abd pain, n/v/d, dysuria, loss of smell/taste. States that she got both her vaccine shots outside of clinic (Pfizer), but can't remember the date. Pt admitted on 7/10/21. Pt was found to be hypoxic and was treated with decadron. She was not a candidate for remdesivir due to low GFR. She was given lasix to alleviate leg swelling which improved. On date of discharge patient is afebrile and no longer requiring supplemental O2. She is to remain isolated until 7/20/2021

Patient was hospitalized 15 days after receiving vaccine. Admission was not due to vaccine and was admitted for acute ascites and patient had reported fever and hypoxia. Patients admission resulted in death 7 days after being admitted to hospital.

medical history most significant for hypertension, type 2 diabetes, hypothyroidism, pacemaker, who presents to the Emergency Department today due to shortness of breath that began approximately 2 days ago. The patient reports that the shortness of breath had a gradual onset and is getting worse. She normally wears 1.5 L of oxygen at night. However, she has been wearing it throughout the day. Upon EMS arrival, she was satting well. However, with any exertion, she dropped her sats for which they started her on non-rebreather. She also reports bilateral knee pain that has been chronic along with chronic back pain. She denies chest pain, abdominal pain or fevers. She is COVID vaccinated. She received her 2nd doe