Pfizer

PATIENT GOT HER FIRST COVID PFIZER VACCINE AT 12/31 IN THE AM. HAD GOTTEN FLU LIKE SYMPTOMS AND HAD BEEN SICK FOR A COUPLE OF DAYS. HAD NAUSEA AND VOMITTING DURING THIS TIME AS WELL. ON 1/3 THE CARE GIVER WENT TO CHECK ON HER PT AT HER LTC FACILITY WHERE SHE LIVES AND SHE WASN'T ACTING RIGHT. SHE WAS UNABLE TO DO A STROKE EXAM. PT HAD NO MOVEMNET IN ARMS OR LEGS AND WAS UNABLE TO SPEAK. PT WAS VITALLY STABLE AT THE TIME. EMS RECORDED THAT THEY THOUGHT DIAGNOSIS WOULD BE STROKE, PNEUMONIA OR SEPSIS. AFTER ARRIVAL AT THE HOSPITIAL DETERMED THAT SHE HAD A STORKE, ACUTE KIDNEY INJURY, ABNORMAL LFTS.

Slightly lightheaded. Checked B/P and observed. B/p on discharge 146/80 and lightheadedness subsided

Dizziness - was dizzy earlier, didn't sleep well last night. B/P checked, on discharge b/p was 116/57. Encouraged to hydrate and given some water. Denies dizziness on discharge

Temp 103.5 temporal, myalgia, SOB, loss of balance, SpO2 85% RA lying down Symptoms appear to be resolving this AM. Sp02 98% on 2L O2. Temp 98 temporal - at 7:45am

Uncle received vaccine on 2/9/21 at 11:30am. Had acute myocardial infarction on 2/10/21 at 08:30am where he proceeded to fall and fracture hip. Transported to emergency department and treated for AMI. Stabilized and taken for surgery to repair hip fracture. To be discharged on 2/15/21 to rehabilitation facility. Up until this point he was very healthy and active, despite his age, living unassisted at home.

emergency Room HPI This is a 90 y.o. male who presents presents in the emergency room by ambulance from local nursing home for complaint of fall with no localized pain but was said to have low blood pressure of 80/40 and low O2 sat of 77%. PCP said to send patient to the ER for evaluation. Patient is COVID positive but is said to have completed the vaccine on 19th of January 2021. In the ER blood pressure is 122/71, respiration 18, pulse is 68, temperature 98.7° F and O2 sat of 95% on 4 L. Patient is confused and not answering questions which is his baseline.

2/24/21 Patient Died. 02/23/21. Patient came to ED for weakness/falls. Patient had fallen on 02/21 and 02/23. UA was done in LTC, and he was started on ciprofloxacin 02/22/21. Treatment was to put patient on comfort cares (morphine + lorazepam)

unable to stand or walk; Legs no longer able provide support; mentally increased disorientation at times; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262) on 01Feb2021 at 15:00 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 05Feb2021 4 days after vaccine, patient was unable to stand or walk with rolling walker. Prior to vaccine, patient was able to ambulate slowly with rolling walker. Legs no longer able provide support. Also mentally increased disorientation at times. Patient visited doctor office due to the events considered as disabling. At the time of the reporting the patient had not yet recovered from the events.

02/10/2021: Weakness, fatigue, headache, myalgia, bilateral bleeding from ears. 02/28/2021: Weakness that I had to use a walker to ambulate (normally ambulate independently), dizziness/vertigo, sore gums, weakness more pronounced in lower extremities below knees.

Dark bruise at the inner part of my right thigh, near the groin, the size of three quarters (of Dollar), my right leg became weak, could not fold, have difficulty walking

Blood pressure dropped dangerously low, dizzy, weak, off balance, exhausted, achy, headache, nauseous

3/5 Patient presented to ED after being found on floor at home and complaining of neck pain. primary care giver noted that patient had had several recent falls, increasing weakness and decreased appetite for several days prior to presentation. Pt was found to have UE weakness in ED and cervical spine CT showed C2 fx and cord hematoma resulting in severe cervical stenosis. Screening nasal swab for admission was positive of SARS-CoV-2. Pt had no hypoxemia. 3/6 pt was intubated for acute hypoxic hypercapnia secondary to hypoventilation from medication. The was then found to have MRSA pneumonia. He was treated with both dexamethasone and IV vancomycin. 3/8 had C2-C6 laminectomy Progressed slowly and was extubated and worked with PT/OT/ST. Found to have occult sacral fx. Was eventually discharged to SNF on 3/17/21

Total body aches - especially joints; feeling extremely tired. Impacted ADL - Significant Mobility impact. S&S started early morning 4/12, unable to sleep due to pain. c/o S&S 4/13 - 4/16, unresolved as of this submission. Son is a physician and advised to take Aspirin for pain.

Significant drop in blood pressure, nausea, dizziness, significant decline in functional capacity- fell x 2 , was independent now requires full hands on assist for Balance and fall prevention

dizzy; the whole room began to spin/he was still wobbly; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, Expiration Date: 31May2021) via intramuscular on 31Jan2021 16:15 on right arm as single dose for covid-19 immunisation. Medical history included mesothelioma from Aug2019 and ongoing. The patient concomitant medications were not reported. Prior Vaccinations (within 4 weeks) reported as none. Patient took the first dose of the Pfizer covid vaccine shot yesterday at 4:15 pm. Everything was fine till about 10:30 at night when he was ready to go to bed. patient got up from his recliner, patient was dizzy and the whole room was spinning so he sat down again and tried again 5 minutes later, and he was still wobbly on 31Jan2021 22:30. Then after he sat there for a while, he was ok. patient did not have an immediate reaction. Patient asks if his reaction was serious what would they have treated him with for the dizziness. Patient asks if he should take the second dose and if the dizziness is normal. Last night patient was thinking about going to the hospital since he got panicky but then it passed. patient did not go to the hospital since there was a snowstorm. Patient did not visit emergency room and physician office. Treatment was declines any, he was drinking plenty of fluids. The outcome of the event dizzy was recovered on 31Jan2021 and unknown for another event.

Patient was a healthy, active man, walked the dog 2x a day, wrote about classical music, etc. until 02/23-26/2021: Atrial fibrillation episodes that would not resolve themselves; 03/03/2021: Cardioversion at Hospital which did not work; medications were changed or adjusted over the next weeks, Metoprolo tartrate 25mg was added 03/10/2021. Patient was anxious, napped during the day, couldn't sleep at night, couldn't concentrate on anything for any length of time, breathing irregular, had no energy to walk; 03/11-16/2021: in Hospital 04-10-14/2021: in Medical Center, for ablation and pacemaker. Great improvement, had more energy, was ale to drive again but was not back to his active self pre- 02/23/2021. Medications as of 04/27/2021 were Allopurinal 300mg daily; Atorvastatin 10mg, daily; Eliquis 5mg 2x a day; Furosemide 20mg daily; Melatonin 10mg, daily; Metoprolol succinate ER 50mg daily; Valsartan 40mg, daily; Adult 50+ Eye Health, daily; multivitamin, 1 daily; Docusate sodium 50mg as needed. By 05/26/2021, the patient is once again sleeping off and on during the day, has no energy, coughs more, can't concentrate, has lost his appetite, is anxious and discouraged. His speech is often muffled instead of clearly enunciated as is his wont. The medications have been adjusted again: as of 06/07/2021, Metoprolol 200mg, daily; Furosemide 40mg daily; the other medications remain the same. The patient, over the more than 3 months, has had xrays, electrocardiagrams, CT scans; bloodwork done. The question is: is it possible that these seemingly uncontrolable atrial fibrillation episodes are an adverse reaction to the second Pfizer vaccine? Has research been done on the vaccine and cardiac problems?

Patient experienced sudden and severe sweating over every inch of his body, described as if he was leaking out of every pore all at once. He got dizzy as if blood was rushing to head and attempted to make it into his bedroom where he knew he could safely collapse on the bed if needed. He reported seeing the room wobble as he was stumbling to his bed. He barely caught the edge of it before falling onto it. After several minutes, the sweating and wooziness subsided. When asked, he said he had never experienced any of those adverse effects before.

I received two Covid-19 injections, dated: 3/26/21 (Lot Number EN6202) (I can't be certain whether it is EN6202 or FN6202 -- tiny font) 5/1/21 (Lot Number EP6955) (font is clear in this case) In May, my right thumb became stiff. It sticks when I try to bend or straighten it (whenever I need to go from bent to straightened or from straightened to bent). My arm bothers me at night when I sleep but as soon as I get up and start moving around, it's OK. But it bothers me when I am trying to sleep.

I faint anf fell twice hurt my back once; I faint anf fell twice hurt my back once; hurt my back once; Dizzy spells; Constipation; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via an unspecified route of administration in Jan2021 (a week before reporting) at single dose in left shoulder for COVID-19 immunisation. Age at vaccination was 91 years. The patient's medical history and concomitant medications were not reported. About 24 hours after shot he started having some dizzy spells and then fainted and fell a couple of times and hurt his back once. He stated he also had had constipation since the shot and do not know if that is related or not. The patient wanted to talk to see if he could get his second shot. He is taking some pain killers for his back. With regards to Physician Office/ Emergency Room: patient stated, 'This for my back and nothing else of that'. The outcome of the events was unknown. The information on the lot/batch number has been requested.

back and neck pain/ back was hurting and went up into his neck; back and neck pain/ back was hurting and went up into his neck; feeling "woozy/dizzy"/ lightheaded; This is a spontaneous report from a contactable consumer (patient's daughter). A 91-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number not reported, via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter said that her father received his 1st dose of vaccine on 25Jan2021. Yesterday on 01Feb2021, patient started experiencing back and neck pain and feeling "woozy/dizzy". She also reported that patient's back was hurting and went up into his neck. Reporter said that he is really dizzy, that's what he's concerned about. And today on 02Feb2021, he was feeling lightheaded and dizzy. Reporter asking if these could be side effects from the vaccine since its a week later. She also would like to know if he should get the second shot. The outcome of the events was unknown. Information on the lot/batch number has been requested.

91 yo father received vaccine, was mobile and alert before first shot, but required wheelchair by second vaccination due to being weak. After second vaccination, was not able to stand or move after 36 hrs, at which point he was taken to the hospital. At hospital, all vital signs were good except an MRI showed cancer in spine. Shot was given 3/1 and my father passed on 3/18. Obviously this shot did not cause metastatic cancer, but I believe it did induce an inflammatory response of some kind that caused it to progress extremely quickly.

About 10 minutes after the vaccine the patient complained of headache/lightheadedness. We supplied the patient with a bottled water and he drank some. About 3 minutes later the patient complained of not feeling well/right. His eyes then rolled back in his head and he began to shake. He did slump to the side in his wheelchair. He was breathing although it seemed a bit labored. He was not responsive verbally when w asked him if he was ok. After about 2 minutes, the episode seemed to end. He moved and straightened up. His eyes opened and he was able to answer questions. He complained of feeling tired. He wanted to lay down and he said his stomach was a bit upset. 911 was called while the patient was not responding. They arrived after he awakened. He was given oxygen and eventually placed on a gurney and taken to the ER.

Felt like his throat was closing. He was given 25mg benadryl and then developed dizziness, heart racing, chest pain, shortness of breath, jaw pain. Was in SVT on arrival to ED

Patient had a fall at extended care facility, patient had worsening cognitive function. CT reveals subdural hematoma

Since receiving the COVID-19 vaccine, patient has been sleeping 20 hours a day with decreased oral intake. On 1/30, his mobility began decreasing and he was no longer able to use the walker he normally uses. He is also usually alert and oriented x 4, altered (including hallucinations) when admitted to the ICU on 2/1/21. Also with hypertension and AKI. Management: precedex for agitation, labetalol for hypertension, fluids and foley for AKI

received second Pfizer COVID dose on 1/24 to left deltoid. On 1/26 began with pain in bilateral arms and hands. On 2/1 had limited range of motion. Receiving Tylenol PRN for pain. On 2/7 new order for ibuprofen 600mg Q8hr. PRN. On 2/10 rating pain 10/10 sent to ER for eval and treat. Labs work CT negative, dose of morphine and returned to facility same evening. On 2/12 rated pain right 5/10 and left 8/10, continue to monitor and follow up with physician

sciatic problem/ sciatic nerve going down my leg; feel pain that goes down his right leg/ bum down to his foot; I have a tough time walking; This is a spontaneous report from a contactable consumer (patient). A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL92U3) solution for injection, via an unspecified route of administration on 21Jan2021 at a single dose for Covid-19 immunization. Medical history was reported as none. Concomitant medications included different pills. The patient called and would like to know if his sciatic problem in his left side was related to the Covid vaccine he received. After he got his shot he went down and parked for 15 minutes and then he went to ride home, and when he got out of the car he had sciatic nerve going down his leg on 21Jan2021. He can't seem to get rid of it and now he was just wondering what would have done that. He felt the pain that goes down his right leg/bum down to his foot, he had a tough time walking on 21Jan2021. Patient was taking different pills and stated, "nothing real serious but this is little bit serious". Treatment for the events: patient tried different saps and stuffs to put on his leg and he had also taken Tylenol arthritis pill. Outcome of the events was unknown. No follow-up activities are needed. No further information is expected. Information regarding the lot/batch number has been obtained.

92 year-old male with PMHx of vascular dementia, BPH, MDD, sleep disturbance , basal cell carcinoma of neck, osteoarthritis, BLE edema, Guillain-Barre syndrome 30 years prior, s/p COVID positive on 1/11/21 and received IV Bamlanivimab. Sent to hospital on 2/2/21 for altered mental status, generalized weakness with inability to lift bilateral UE and difficulty moving his BLE. He was treated for UTI with 7 days of Cefepime for Morganella Morganii. He was followed by neurology with MRI of the brain and CT of the spine without acute findings. Lumbar puncture unable to be obtained. He received 5 day course of IVIG for presumed Guillain-Barre . EMG showed generalized sensory motor polyneuropathy both axon loss and demyelinating type severe in degree. However, he did not recover from his GBS symptoms, was transferred back to the nursing home and died on 2/15/2021.

After getting the second vaccine on the 5th of March at 7 PM, he couldn't breath that night during the night, so had to get out of bed to sit up and short of breath a good portion of Saturday.... also unable to control bowels which is unusual for him and pooped in his pants which was awful for him. He felt dizzy and tired all Saturday and Sunday. Doing better as of Monday the 8th. He had no adverse affects from the first dose.

limited range of motion; pain to both arms and hands; This is a spontaneous report from a contactable nurse. A 92-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 24Jan2021 (Batch/Lot Number: EN5318) at a single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had the first dose in left arm (LOT EJ1686) on 03Jan2021. The nurse reported that patient is in a long term care facility and began with complaints of left arm pain on 26Jan2021 then complained of pain to both arms and hands on 01Feb2021. She says the patient has limited range of motion from unknown date and still, and is complaining of pain still. She says that the patient was started on ibuprofen 600mg every 8 hours as needed by mouth, and was sent to the ER on the 10th for evaluation, where they did a CT and lab work, which came back ok, and he was sent back to the facility. The patient was not admitted when he went to the ER, he was evaluated, then sent back, he returned the same day. The reporter mentioned that it seems the events were a little more than a minor reaction. The reporter mentioned the events does not meet the VAERS criteria for a serious event, but it did disrupt the patient's ability to do normal function, as he has needed help getting dressed. At first he reported 10/10 pain and was requesting to go to the hospital, and now his right arm is much better, he says a 5/10 pain level and left an 8/10 pain level. She says that he admitted to pain this morning, but he did decline pain medication, so pain is still remaining. Outcome of pain in extremity was recovering , limited range of motion was not recovered. Therapeutic measures were taken as a result of pain in extremity.

Shingles and Hospitalization within 30 days of vaccination. 2/18/21 PCP ordered outpt wound for shingles and unstageable decubitis ulcer (unknown onset date of shingles). Seen in ER on 2/19 and admitted discharged to rehab unit on 2/23/21. reported 1-2 week history of generalized weakness and frequent falls, poor oral intake and shingles. 2/19/21 pt c/o heart racing and irregular. Found to be in Afib with RVR. 2nd dose of Pfizer given 3/19/2021 went to ER 3/24 for pneumonia.

First Dose received 3/1/21: Patient had severe arthritic reaction in neck for 4 days Second Dose received 3/22/21: Patient was having balance problems, facial droop, slurring speech and left leg and arm weakness. Taken to the Emergency room and diagnosed with a right basal ganglia stroke. Patient was in the hospital as an IP until 4/2 and is currently in an Inpatient Rehab facility with mod-max assist, learning to walk and eat. He still does not have use of his left arm. Patient was completely independent prior to this event and his mental capacities are intact.

6 days after receiving the first dose of Pfizer Covid-19 vaccine, he developed severe disequilibrium to the point that he had severe difficulty sitting up and ambulating. The disequilibrium was severe for twelve days but then seemed to be largely resolved. The second Pfizer Covid -19 vaccine was received on 02/06/2021 (lot EN5318) and the severe disequilibrium began again February 12. complete evaluation with CT head, abdomen and pelvis, chest X-ray, lab , EKG and echocardiogram showed no explanation for symptoms. The second round of severe disequilibrium resolved by February 25.

Shoulder pain/right shoulder is bothering him a little; Unstable feeling; unstable on his feet; back is bothering him; mild tiredness/ he is very tired; weakness/ weak; periods of dizziness/ lightheaded; sleepy; This is a spontaneous report from a contactable consumer (patient). A 92-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3246, expiration date not reported) via an unspecified route of administration in right arm on 30Jan2021 at 10:00 am (at the age of 92-year-old) as a single dose for COVID-19 immunisation in other type vaccination facility: park. Patient's Medical History (including any illness at time of vaccination) was none. Patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. There was no history of any previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). There were no other additional Vaccines Administered on Same Date of the Pfizer Suspect. On an unknown date in 2021 patient experienced dizziness, weakness, tiredness, was sleepy, lightheadedness, unstable feeling. On 30Jan2021 patient had shoulder pain (arthralgia). It was reported that patient received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine 9 days ago. However, he said he was still experiencing mild tiredness, weakness, and dizziness. He wants to know if these side effects are still associated to the vaccine and if it is normal that he is still experiencing it 9 days after his 1st dose. He also mentioned that he has no temperature and his pulse and blood pressure was normal. It was then reported that patient was still suffering some side effects 2-1/2 weeks after getting the COVID-19 Vaccine. He said the side effects come and go. He said the side effects will last 4-5 hours, and then go away, and come back the next day. He said he has checked his blood pressure and pulse, and they are both OK. He said he uses an oximeter to check his oxygen level, and his oxygen is good. He said he sleeps well at night. He said he is having periods of dizziness, weakness, and feeling tired and sleepy. He said he feels lightheaded and unstable on his feet, also. He said he feels fine now. He said his right shoulder is bothering him a little, too. He said his right shoulder was uncomfortable and bothered him if he laid on it at night. Reported his back was bothering him, so he bent over a little, but if he stands up straight, he was about 5'10". He stated his side effects started a day or so after he received his COVID-19 Vaccine, and he can't remember the exact day. He said the side effects lasted continuously for several days, or about a week. He said now his side effects are sporadic. He said in the morning he will wake up and feel OK, and then after a while the side effects start. He said some days his side effects will start in the morning, and other days his side effects won't start until the afternoon. Patient declined any treatment. He said he read that any side effects from the COVID-19 Vaccine only last 2-3 days. Reporter wants to know if it is a problem that he is still having side effects after 2-1/2 weeks or is there some action he should be taking. He said he figured Pfizer is the expert, so he would ask Pfizer directly. He said otherwise, he was thinking of going to an urgent care to see what the urgent care thinks of his side effects. There was no emergency room or physician office visit. There were no relevant tests. Reported his second COVID-19 Vaccine dose was scheduled on 26Feb2021 at 9:30AM and asked if still can get the 2nd dose Vaccine after having a reaction to the 1st dose. No PQC was present. Outcome for the events weakness, periods of dizziness, tiredness, lightheadedness, sleepy, unstable feeling was not recovered, outcome for shoulder pain was recovering and for unstable on his feet, back discomfort was unknown.

diabetic; He didn't eat much last night and didn't eat this morning.; temperature was 100.3.; Nausea; feeling dizzy; Rash; face real red; shaky and jittery; shaky and jittery; This is a spontaneous report from a contactable consumer. A 92-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0167), via an unspecified route of administration in left arm on 29Apr2021 at 14:30 (at the age of 92-years-old) as unknown, single dose for COVID-19 immunization. Medical history included patient first diagnosed as pneumonia, reporter was unsure pulmonary lung infection and pneumonia are the same and treated 3-4 weeks ago for a pulmonary lung infection and type 2 diabetes mellitus. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No adverse event prior vaccinations. Patient did not perform any relevant test. Patient took a lot of medications after being in rehab but concomitant medication was not reported. Vaccine was not administered at (Privacy)Facility. On 30Apr2021, the patient experienced nausea, feeling dizzy, temperature, developed rash, red face and shaky and jittery. Patient had been bringing up stuff from lungs some of the stuff bothers and makes patient nauseated, didn't eat much last night and this morning. Patient was diabetic so she thought it might be related to a sugar thing. Patient won't drink any water and temperature was 100.3. She put a cold towel on face and it came to normal color and face was real red before, on 30Apr2021. Diabetic on an unspecified date. Reporter asks would that condition aggravate the side effects of the vaccine. Patient did not visit to physician office and emergency room. The patient underwent lab tests and procedures which included body temperature: 100.3 on 30Apr2021. The outcome of the event nausea was recovered and rest of the events are unknown. Follow-up attempts completed. No further information expected.

My father was in weak condition to begin with. He didn't get out of bed for the next few days after receiving the vaccine. The little amount that he ate was consumed in bed. He began aspirating his food which lead to pneumonia. He wasn't strong enough to fight off the pneumonia even with antibiotics. He died on 1/23/21. While he might have passed soon in any case, I believe that the vaccine may possibly have increased his weakness/exhaustion thereby hastening his demise.

Pt from home via EMS. Pt reports increased weakness since getting the covid vaccine on the 24th. Pt is normally ambulatory at baseline, but has not been able to get around his house. Pt was found to be 83% on RA and was audibly wheezing per EMS. No history of respiratory issues. Denies fever, but has had a productive cough. A&O x4. Pt received Duoneb treatment in route. Acute respiratory failure with hypoxia , Pneumonia due to COVID-19 virus , Elevated LFTs. Patient admitted to hospital on 2/3 and is still inpatient

death Narrative: 92 yo male seen in clinic on 12/30/2020 for transfusion, hbg 6.9. PMH includes HLD, CKD, myelodysplastic syndrome, DM, prostate cancer, HTN. Pt also received COVID19 Pfizer vaccine the same day. The patient denied any prior severereaction to this vaccine or its components. Post-transfusion, patient had a mechanical fall (per patient he was seated and used the cane to help him stand. However the cane slipped on the floor causing the patient to fall, patient hit his head and injured his right hip, no loss of consciousness at the time). Rapid response team was called and patient was admitted to the ED. Pt was found to have subcapital right femoral neck fracture, scalp contusion, and TBI (per ED provider's note). Ortho evaluated and said patient wasn't a surgical candidate. During his hospitalization, patient tested positive for COVID19 on 1/12/2021, pt was asymptomatic at the time. On 1/13/2021, pt exhibited mild URI symptoms, no respiratory distress. He was started on cetirizine, Montelukast, albuterol, and inhaled steroids to manage his symptoms. Dexamethasone was started on 1/14/2021. Chest Xray was ordered on 1/17/2021, pt's respiratory was slowly getting worse, resting O2 sats were in the high 80s and low 90s with IS. On 1/18/2021, CXR shows patchy bilateral airspace opacities suspious for pneumonia of bacterial or viral etiology. Pt was started on remdesivir 01/18/2021 (5 doses, from 1/18-1/22/2021). Pt required 5-6 LPM of oxygen at rest. Pt was then transferred to the ICU. His oxygen demand continued to increase and his condition worsened. On 2/14/2021, pt started to desat into the 70s on max high flow. Patient/family agree to comfort care. Medical cause of death was listed as "acute hypoxic respiratory failure due to COVID19." Patient expired 1/24/2021.

Patient received first dose of vaccine on 1/7/21 at a community Public Health clinic. On 1/29/21 he received a second dose at the community Public Health clinic. On 2/5/21, the patient presented to the ED with complaints of shortness of breath worsening over the last 2 weeks. Patient reported that he had decreased exercise capacity and increased coughing with sputum production intermittently. Patient reported that he had been feeling chilled, but no fevers. Patient was admitted and treated with Decadron and Remdesivir. Patient experienced increased oxygen requirement. Patient was a DNI and did not want to be on life support. After discussion with the patient and family, patient was moved to comfort care. passed away on 2/11/21.

Disorientated; in a lot of pain in his chest and rib area; in a lot of pain in his chest and rib area; hurt to breathe and move; shaken up; Short of breath/It hurt to breathe; Concomitant medication:ongoing prednisone for immunotherapy; Concomitant medication:ongoing prednisone for immunotherapy; This is a spontaneous report from a contactable nurse. A 93-year-old male patient (reporter's father) received first does of BNT162B2 (Lot#: EN5318), via intramuscular on 28Jan2021 10:00 at single dose for COVID-19 immunization. Medical history included ongoing prostate cancer metastatic diagnosed a few years ago and immunotherapy. Concomitant medication included ongoing abiraterone acetate (ZYTIGA) at 1g, once a day for prostate cancer and ongoing prednisone at 5 mg, tablet, twice a day, by mouth for immunotherapy. The caller stated she is reporting a reaction her father had to Pfizer's COVID-19 vaccine. The patient experienced disorientated, in a lot of pain in his chest and rib area, hurt to breathe and move and short of breath/it hurt to breathe on 29Jan2021. The reporter seriousness for the events was medically significant. The events didn't require a visit to emergency room or physician office. The patient did go to urgent care. The caller explained her father became disoriented. He received the first vaccine on 28Jan2021. The next day, her father began to move his car around 12 pm and he became disoriented and stated he wasn't going to drive. Caller stated they were not aware of this disorientation until Friday, 29Jan2021. Her father was not sleeping and was up the night before because he was in a lot of pain in his chest and rib area. It hurt to breathe. He was short of breath. It hurt to move. Caller clarified further her woke up feeling so bad he thought he was going downhill. He thought his cancer got worse over night. He told the caller's brother after he became so disorientated that he was no longer going to drive because he was so shaken up. He was taken to urgent care on Friday, 29Jan2021. He was prescribed Naproxen, 500 mg Friday evening and he slept all night for the first night in years. He usually gets up in the middle of the night to use the bathroom. He woke up on Saturday morning, 30Jan2021, and he was feeling 100% better. He recovered completely. He was up moving around and in no pain. Caller verified she has no NDC, Lot number and expiry date for the Naproxen her father was prescribed. She didn't see any of that written on the discharge papers, that may be with the pharmacy. She wanted to put a chest x-ray was done. He has Metastatic Prostate Cancer and the pain was coming from the lesions on his lung and rib. Caller explained the Chest X-Ray showed the mets (metastasis) but no new lesions, no infiltrates or anything. It showed nothing related to the COVID-19 vaccine.The patient underwent lab tests and procedures which included Chest X-ray: showed the mets (metastasis) but no new lesions, no infiltrates or anything on 29Jan2021 and EKG: essentially normal on 29Jan2021. The outcome of the events disorientated, in a lot of pain in his chest and rib area, hurt to breathe, shaken up and move and short of breath/it hurt to breathe was recovered on 30Jan2021. The reporter's assessment for all the events was related.; Sender's Comments: Based on the compatible time association, the contribution of suspect vaccine BNT162B2 to all events disorientation, chest pain, musculoskeletal chest pain, movement disorder, shaking, and shortness of breath cannot be excluded. The ongoing prostate cancer metastatic status and immunotherapy may be major cofounders. 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.

Sleeping more than usual and off balance. He fell and split his head on right side. Called rescue and brought to hospital. Had a hematoma and was sent to rehab for two weeks. Lost hearing to the right ear which was his better ear. Had second shot on March 15th and tired sleeping most of day. Two days after shot, he went to get up and fell cuttiing his head in the back. We were able to stop bleeding, applied ice and facility gave us bandaging material. Still healing and sleeping most of the day and night.

Pt presented to the ER 3/10/2021 c/o inability to ambulate and progressive weakness and muscle pain. Pt received his 2nd covid 19 vaccination on 2/15/21 and was dx with shingles a week later of the l ear. Pt reported he was weak after vaccine and never really got better progressing to inability to ambulate and groin/muscle pain resulting in the er visit. He was evaluated by PT and was found to be 2 assist with rapid decline. He was living independently prior to this using no assistive devices. He was admitted to the hospital and ultimately discharged to rehab on 3/12/21 where he remains presently according to the daughter.

K62.89 - Rectal pain R42 - Dizziness R41.0 - Delirium R55 - Syncope R77.8 - Elevated troponin M25.552 - Left hip pain Z86.2 - Hx of thrombocytopenia M79.662 - Pain in left lower leg

Could not stand; Body aches; Neck pain; Headache; Felt very unwell; This is a spontaneous report from a non-contactable consumer reporting for a patient. A 93-year-old male patient received unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not available/provided) (age at vaccination: 93 years) as single for covid-19 immunization was administered at health clinic. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history and concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient was not diagnosed with COVID-19. On 02Feb2021 (same day patient received vaccine), patient awoke from sleep with body aches, headache, neck pain. Patient felt very unwell, could not stand, sat on edge of bed for approximately 1 hour until the symptoms passed and patient was able to get back to sleep. When patient woke in the morning, felt well and had no further symptoms. It was unknown if patient received any treatment for the adverse events. The case was reported as non-serious. The outcome of all the events was recovered on an unknown date in Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

hands and legs swollen; arm was a little sore; This is a spontaneous report from a contactable consumer (patient). A 93-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL3246 and expiry date was not provided), via Intramuscularly, in right shoulder (right arm)on 04Feb2021 at 10:30 (at the age of 93-years-old) as a single dose for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. No previous immunization history with the Pfizer vaccine considered as suspect. No additional vaccine was administered on same date of the suspect. No prior vaccinations within 4 weeks. No adverse events following prior vaccinations. On 04Feb2021, patient experienced hands and legs swollen and arm was a little sore. Patient's arm was a little sore last night but that did not bother him. About 10 hours later between 19:00 and 21:00 he got up to go home from watching a movie and both of his legs and both of his hands were swollen up. Reports he had a heck of time getting up for a bowel movement. Patient's wants to know if this will reoccur itself tonight or was it a onetime thing. Reports it was not life threatening. His hands were swollen and he could not make a fist. The swelling was in both his hands and legs. Sometime during the night it got down to normal, and his hands and legs appear to be normal now. Since waking up about 30 minutes ago his hands and legs appear to be normal. He was just surprised and shocked that he experienced that about 8 to 10 hours after the injection. Patient did not feel the darn thing when he received the injection. As reported he takes a whole bunch of things for his other problems but they do not have anything to do with this. No treatment was received. Events does not require a visit to emergency room or physician office. Lab test included body height and result was shrinking. Second dose of vaccine was due on 25Feb2021. The outcome for event hands and legs swollen was recovered and for arm was a little sore was unknown. Follow-up attempts are completed. No further information is expected.

2 weeks after first shot, pt. experienced stroke symptoms. Called 911 and brain scans found evidence of 2 stroke areas in back of brain. Weakness, inability to talk, droopy side of face. They put him back on prevastatin and eliquis. He was overnight in he hospital. Has had recurring sudden spells of weakness on right side, with subsequent falls, ever since - about every week or 2. Recovers in 1/2 hour. No new strokes observed. He had similar symptoms 2 weeks after his second shot, but no signs of new stroke. We have been trying new treatments to stop the weak spells, not sure if they are working.

The vaccine was given on Monday. Tuesday afternoon he developed weakness in both legs and could not stand up. This was a new development; he had neuropathy in one leg but he had been able to stand up and walk three hours before. He was helped to the bathroom. He said he felt better and might want to stand up again. He was helped to bed. He was found dead around 5:30 Wednesday morning. He was 94 years old and had a lot of medical conditions. No one has indicated his death had anything to do with the vaccine. I'm sure it's just a coincidence that he died so soon after receiving the vaccine

I received my first COVID 19 Pfizer Vaccination on Jan. 21, 2021 from clinic about 2:30 pm. I am age 94. My wife brought me home about 3:30 pm and I was tired and went to bed and to sleep. I slept soundly until about 8 pm, and my wife awoke me to eat. I was too weak to sit up or stand, my legs felt like rubber. I didn?t feel like eating, and I couldn?t answer her questions coherently. My wife was worried and called the 911. They checked me and found my vital signs were normal, so they helped my wife get me settled in bed. The next few days I still felt weak and had to use a cane or walker. My second dose is scheduled for February 11, 2021 at 2 pm. Will I likely have worse side affects? What precautions should I take.

Patient was discharged after receiving vaccine. patient presented with symptomatic AS to the hospital. Family declined intervention. Received vaccine prior to discharge. His wife reported that he was sluggish/unresponsive in the evening that self-resolved. Declined ED evaluation. Currently only experiencing dizziness. Given severity of underlying cardiac disease, unclear if vaccine was cause of symptoms.

started him on his oxygen; O2 went from 85 to 98; bp 155; notably shuffled; became non-responsive; looks like he is having a stroke; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 25Feb2021 13:45 (at 94-year-old) at single dose (Arm Right) for COVID-19 immunization. Vaccination facility type is clinic. Medical history included congestive heart failure, early stages dementia. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 04Feb2021 (at 93-year-old) on right arm for COVID-19 immunization. The patient had no covid prior vaccination. Patient has no known allergies. The patient (father) seemed to be doing fine until 19:45 on 26Feb2021 roughly 30 hours after vaccination. He has early stages dementia, so if he was feeling ill he didn't report anything, and they didn't notice anything. He got up from the table, notably shuffled the 10 feet to the bathroom, sat down on the toilet before we could "pull down his pants", and then became non-responsive. The reporter said to her son it looks like he is having a stroke. They got him onto the floor. started him on his oxygen concentrator (usually used only at night), O2 went from 85 to 98; bp 155 from an unspecified date. after a while he came to. he is dnr, dni, so they didn't call an ambulance. Eventually they got him up. no signs of stroke. He does have congestive heart failure. This has never happened before, and he has no history of falling. Daughter was reporting the next morning. He has not yet been awake since this occurred. it is now 8am 27Feb2021. Covid was not tested post vaccination. The outcome of the event o2 went from 85 to 98 was recovered, while for other events was unknown. Information on the lot/batch number has been requested.

Pt had long complicated course spanning almost a month. He was initially admitted for right intertrochanteric hip fracture (following a fall at home) for which he required surgery. Also had bacterial pneumonia and received Zosyn. He was close to discharge at 1 point but then had Covid testing done which came back positive. He gradually worsened from there with acute hypoxic respiratory failure and very poor oral intake. He had multiple episode of hypoglycemia and required D5. He was made care only but improved on his own and was back on medical Mx. It did not last long and he again became very tachypnic in 60s and hypoglycemic. He was made care again. Pt passed away peacefully with his daughter at the bedside on 3/11/21 at 11 AM Causes of Death: 1. Cardiopulmonary arrest due to reason #2 2. Failure to thrive due to reason #3 3. Old age and COVID-19 No autopsy performed.

Within two hours of the vaccine, my father was unable to walk, suffered severe weakness, and had severe shortness of breath. The weakness, inability to walk, and shortness of breath lasted in a severe state for 48 hours. After that, he continued to be unable to walk, suffered weakness and had shortness of breath until he died. He never recovered the strength and vitality he had prior to the 2nd vaccine. That 2nd shot shortened his life and killed him.

he has a hearing and memory problem; he has a hearing and memory problem; Very bad headache; Fatigue; Dizziness; This is a spontaneous report from a contactable consumer. A 95-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient has a hearing and memory problem. He later clarified the main thing is he wanted to know if he can continue with getting the second COVID vaccination. He wanted to continue but wanted to know if these symptoms will prevent him from continuing with getting the COVID vaccination. He confirmed he has no problems around the injection site. However, this is the second day and in Jan2021, he had dizziness. On 11Jan2021, last night he had a very bad headache and fatigue. This morning he is feeling better, but he still has slight dizziness. He is still three weeks away from getting the next vaccine. He wanted to know if he would be able to still take it. He wanted to be immune and to know if there would be any reason why he cannot take the second dose of the vaccine. He then mentioned these symptoms that he is speaking of are general symptoms and he assumed other people have reported them along with him because it is listed on the information sheet. Outcome of the events of dizziness, fatigue and headache was recovering, other events was unknown. Information about batch/lot number has been requested.

sight impairment/did not see very well/unable to read during report; injection site pain; tiredness; muscle pain; feeling unwell; frequent urination every 15 minutes; signs of severe allergic reaction including dizziness, weakness and sight impairment; signs of severe allergic reaction including dizziness, weakness and sight impairment; signs of severe allergic reaction including dizziness, weakness and sight impairment; This is a spontaneous report from two contactable consumers. A 95-year-old male patient received 1st dose of BNT162B2 (Pfizer BioNTech COVID-19 Vaccine ), via an unspecified route of administration in upper right arm on 16Jan2021 11:00 at single dose for vaccination. Medical history included diabetes from 1950 (also reported as 1991) and ongoing. There were no concomitant medications. The patient experienced not in very good shape/terrible reactions on 16Jan2021 12:00. Requested information regarding events relative to the product. Further clarified this event as to include injection site pain; tiredness; muscle pain; feeling unwell; frequent urination every 15 minutes; signs of severe allergic reaction including dizziness, weakness and sight impairment. Patient clarified that all of these events had onset of about 12:00pm-1 hour after Pfizer BioNTech COVID-19 Vaccine administered (16Jan2021 12:00) and had for the most part remained the same since onset, but for sight impairment was on 18Jan2021. The patient did not see very well; caller had to read some of the information provided in this report from forms that patient was unable to read during report. The muscle pain was marginal. The weakness was the same or worse. He wanted a pain reliver or pill. Patient did not plan to get the second dose due to adverse events. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No emergency room/physician office visit. Family medical history relevant to the events was none. The outcome of injection site pain was recovered on 18Jan2021, tiredness, feeling unwell, dizziness was not recovered, muscle pain, frequent urination every 15 minutes was recovering, severe allergic reaction, weakness, sight impairment was unknown. Information on the lot/batch number has been requested.

3 days after vaccination, person was somewhat disoriented. 4th day after vaccination, patient fell, hit head and developed subdural hematoma from which he subsequently died.

Pt c/o not feeling well and very weak right after receiving injection, and fell less than 3 hours later, would/ could not eat/drink or walk as usual, became confused and bedbound the same day of vaccination and appetite further deteriorated while weakness and confusion increased.

Came in ED due to a fall and rhabdo. Found to have NSTEMI Monitored symptoms. started on plavix and switched statin to atorvastatin and metoprolol tartrate to succinate discharged home

PT REPORTED TO EMERGENCY DEPARTMENT WITH COMPLAINTS OF WEAKNESS AND FALL 2/15/21. PATIENT STATES THAT HE HAS BEEN FEELING WEAK AND TODAY IT SEEMS WORSE. HE REPORTS ATTEMPTING TO AMBULATE WHEN HIS LEGS GAVE OUT. HE STATES THAT HE DID NOT TRULY FALL BUT WAS ABLE TO LOWER HIMSELF TO THE GROUND. HE WAS UNABLE TO GET UP AND THEREFORE CALLED EMS. EMS WERE ABLE TO HELP PATIENT UP AND AMBULATING. EMS NOTED URINARY BAG HAD GROSS HEMATURIA. PT REPORTS BLOODY URINARY OUTPUT THE PREVIOUS NIGHT. PATIENT COMPLAINS OF PENILE PAIN. NO RECENT ILLNESS INCLUDING FEVERS, URI SYMPTOMS, VOMITING OR DIARRHEA. ASSESSMENT UPON ADMIT: *CONTINUATION SEE BELOW PT REPORTED TO EMERGENCY DEPARTMENT WITH COMPLAINTS OF WEAKNESS AND FALL 2/15/21. PATIENT STATES THAT HE HAS BEEN FEELING WEAK AND TODAY IT SEEMS WORSE. HE REPORTS ATTEMPTING TO AMBULATE WHEN HIS LEGS GAVE OUT. HE STATES THAT HE DID NOT TRULY FALL BUT WAS ABLE TO LOWER HIMSELF TO THE GROUND. HE WAS UNABLE TO GET UP AND THEREFORE CALLED EMS. EMS WERE ABLE TO HELP PATIENT UP AND AMBULATING. EMS NOTED URINARY BAG HAD GROSS HEMATURIA. PT REPORTS BLOODY URINARY OUTPUT THE PREVIOUS NIGHT. PATIENT COMPLAINS OF PENILE PAIN. NO RECENT ILLNESS INCLUDING FEVERS, URI SYMPTOMS, VOMITING OR DIARRHEA. ASSESSMENT UPON ADMIT: THROMBOCYTOPENIA (PRESUMED ITP, CAUSE? VACCINE?), DEXAMETHASONE 20MG PO DAILY. AMINOCAPROIC ACID 5GM IVPB X1 DOSE, 1 UNIT FFP, 2 UNITS PLTS PHERESED

Received the vaccine in the morning and came to ER later post fall. he was admitted with a fracture and later transferred to a higher level of care hospital

Bell's Palsy diagnosis. Following 2nd administration of Pfizer COVID vaccine, 97 year old male found on the floor by housekeeping. Sent to ER due to cuts and bruises. MRI ruled out Stroke. Patient presented with a droopy eye & mouth on one side of face. Complained of ear pain on the same side. Patient also tested positive for COVID without any presenting symptoms via PCR test. Patient's will to live has decreased.

Spasms in leg and arm muscles, unable to stand and hard to eat. Symptoms were much diminished at 10:30 pm and he slept from about 12:30 pm to 10:30 pm and then through the night.

Decedent had unwitnessed fall out of wheelchair 1/25/21 around 9:43am, denied head strike, pain, discomfort. Around 10:02pm, 1/25/21, decedent noted to have slurred speech and fluctuating HR, transported to Hospital and made cmo.

Weakness in the body, inability to stand, cannot support the body, inability to eat and swallow. His face twisted the first day, and he seemed lost in time, and he recovered but after a week he still has no modality, and he began to digest his food. No studies or exams just a checkup with the doctor

being dizzy; he "can't stand straight, I almost fell backwards; This is a spontaneous report from a contactable consumer (patient). A 99-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: Unknown), dose 2 via an unspecified route of administration on 15Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date around three days after the vaccination the patient felt dizzy, and he could not stand straight he almost fell backwards. It was reported that dizziness become worse. Patient asked about how long would side effects last and wanted to know treatment recommendations. Outcome of events was not resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Patient is 102 years old history of hypertension hypothyroidism, patient presenting with altered mental status, hemoglobin of 4.6 with creatinine of 2.53, patient has lactic acidosis, anion gap metabolic acidosis. Stool Hemoccult is positive, platelet count of 23,000 noted. Patient is awake but confused, patient's son is by the bedside.Patient has diffuse oozing from multiple skin wounds,Patient has received 2 units of blood along with 2 units of platelets and 2 units of FFP. Fibrinogin of 209. Hematology service recommended starting dexamethasone for suspected ITP. Patient is a PMH of  spontaneous subdural > 20 years ago, surgically evacuated, HTN, Hypothyroidism ,pre-diabetes who presented to the ED with CC of AMS and slurred speech x 1 day. History obtained from son at bedside and chart review. At baseline patient is reportedly very independent and able to ambulate in the home without assistive devices. He handles his own ADLs. Patient reportedly received his 2nd dose of the COVID vaccine on Monday and since then has been experiencing fatigue and generalized weakness, in addition to decreased appetite. AMS started yesterday. He reportedly fell out of bed last night around 2 AM and family found him at 7 AM on the floor. Denied loss of consciousness. He was evaluated by Stroke team, CT of the head was un-revealing for an acute process and stable chronic changes, and CTA revealed some mild intracranial stenoses, Stroke team felt was unlikely to be an acute stroke. He was found to have Hb 4.6 on admission. Platelets were 23, He was transfused 1 unit of blood and 1 unit of platelets. Hematology was consulted and recommended dexamethasone 20 mg daily for 3 days. Rectal exam was done and he was found to be Guaiac positive was started on Protonix 40 BID.

Pt received his 2nd pfizer covid 19 vaccine on March 11 (the lot number was not written on the card unfortunately) and was hospitalized from 5/21-6/4 with new onset profound hypotension and new onset atrial fibrillation with a bradycardic rate.,requiring ICU admission and pressor support. He presented with a fall and was found to be profoundly hypotensive. Sepsis was ruled out and the cause was unclear. He was eventually started on midodrine . He did not require any rate controlling medication. His daughter did not want anticoagulation ordered due to risk outweighing benefit. He was diagnosed with new autonomic dysfunction and new atrial fibrillation and discharged home on 6/4/21