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.

The patient's son reports noticing swelling in both of the hands 1 week after the patient recieved their vaccine.

right leg was pretty large and swollen in one spot; This is a spontaneous report from a contactable consumer (patient himself). A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EK4176, expiry date unknown), via an unspecified route of administration (left arm), on 13Jan2021, at single dose, for covid-19 immunization (also reported as take it for the epidemic). Medical history included diabetes. Ongoing concomitant medications included insulin aspart (NOVOLOG) and insulin detemir (LEVEMIR) both taken for diabetes for about 5 years. The patient stated that he just got the COVID Vaccine on Wednesday, 13Jan2021, and he had the shot in his arm. He informed that he was a diabetic and where he gives his insulin shots, he would have to move to different spots of his body due to getting hard swelling knots. This morning of 15Jan2021, when he got up, he noticed his right leg was pretty large and swollen in one spot. It was on a side where he does give his insulin shots. It was pretty large. He was wondering if this had anything to do with the COVID Vaccine; he clarified that he got the shot in his left arm. The spot was on his right leg and was pretty large and swollen, it was about the size of an egg or a little larger. He added that he does give insulin shots in both his left and his right leg. After so long of giving shots in one spot, he will notice he has been getting hard spots around there. However, this spot was different, it was way larger. Again, the size of an egg. The only difference was the size. No treatment was received for the adverse event reported. The outcome of the event was not recovered.

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.

3/17/21 ER Nurses' Triage note: "To Er via EMS for eval of AMS and low oximetry as reported by nurse at the rehab and long-term care facility. States he has not been his "normal " self the last few days. Upon arrival here patient is alert and verbal. Laughing with staff, poor extremity circulation shows varying oximetry, but after warm blanket applied oxi 99-100% 2lpnc. Is bradycardic with cardiac monitor showing 3rd degree block"

Death Hypokalemia LBBB (left bundle branch block) Pneumonia Anemia Hypoxia Fever Multifocal pneumonia Pneumonia due to COVID-19 virus2.82 Sepsis

Swollen left leg noticed on 3-19-2021 as a result of blood clots identified by ultra sound on 03-31-2021

Asymptomatic infection diagnosed 5/8 after exposed to his daughters who tested positive 4/18/21. He is admitted to the hospital for acute cholecystitis and his asymptomatic admission screen testing positive for SARS-CoV-2 on two different samples and on two different PCR machines on 5/8/21.

The pain went down his left shoulder and back/he developed pain down his right side of his shoulder, and down in his hips/His left ankle, right side heel, and shoulders also hurt.; The pain went down his left shoulder and back; he was having problems breathing/difficulty breathing; possibly a swollen lymph node on his trachea; His left ankle, right side heel, and shoulders also hurt.; He has had pains in different parts of his body that last for 2-3 days and then some place else starts to hurt.; chills; His wife took his temperature and it was 100.3./He has weird fevers for one day with no other symptoms.; jaw pain; Dates for COVID vaccine: (Start: 5Feb2021 Stop: 16Feb2021), first dose on 5Feb2021 and second dose on 16Feb2021; Dates for COVID vaccine: (Start: 5Feb2021 Stop: 16Feb2021), first dose on 5Feb2021 and second dose on 16Feb2021; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 16Feb2021 (Lot Number: EL9267) (at age of 90-year-old) as 2ND DOSE SINGLE for covid-19 immunisation. Medical history included ongoing atrial fibrillation, stent placement from 19Jun2020 and ongoing (successful in the descending aorta), and ongoing Heart problems. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2, administered in Arm Right on 05Feb2021(Lot: EL9263) (at age of 89-year-old) for covid-19 immunisation. The patient would like to talk to an individual regarding his side effects he has been having since his two COVID vaccinations in Feb 2021. Ten days after the second inoculation on 26Feb2021, he woke in the middle of the night with jaw pain. He was in great pain. The pain went down his left shoulder and back . His wife said that morning that those were signs of heart problems. He does have Atrial Fibrillation, and he had a stent placed 19 Jun 2020. He went to the emergency room where they checked him out for heart problems. He had a clean bill of health. They sent him home, and told him to take Tylenol for the pain. The Tylenol certainly helps. It took whatever number of days for it to subside. It subsided for 2 weeks, but then he developed pain down his right side of his shoulder, and down in his hips. Once again they figured they better get back to the ER. They did EKG and a X-ray. There was absolutely nothing wrong with his stent. They told him just to continue with Tylenol to control the pain. He went a third time to the emergency room because he was having problems breathing. The emergency room put him through the COVID entry at Kaiser because of the difficulty breathing. They re did all the previous work, and did a scan of his lung to check for blood clots. He thinks they did that because 6 people died from blood clots from Johnsons and Johnson. They wanted to see if there were blood clots, but there were no blood clots. They told him he needed to make an appointment with his primary who then referred him to a Cardiologist. On 11May2021, he saw his primary doctor who ordered another scan because they found possibly a swollen lymph node on his trachea. The doctor measured that, and said to wait a month to do that again. To see any change in it. On the 26 May 2021, he has his next appointment to get that rechecked. He hasn't had a comfortable day since this started. He has had pains in different parts of his body that last for 2-3 days and then some place else starts to hurt. His left ankle, right side heel, and shoulders also hurt. The pain was under control if he takes ibuprofen, but his doctor advised him against too much of that because of his kidneys. It was very effective. The Tylenol works to some extent, but not like the Ibuprofen. He is just living with it day to day. He can play tennis some days. One day he played tennis and came home with chills. His wife took his temperature and it was 100.3. In the last week and half this has happened two times. After the second shot this has happened probably four times. He has weird fevers for one day with no other symptoms. Ever since 26Feb2021, it has been on a daily basis that some place else hurts. One subsides , but another pain starts up elsewhere. If that is not happening, then his whole demeaner is dead. He is just not comfortable and sitting around he feels like he was wasting what life he has left. He used to be a PE teacher. He has always been in good physical condition. He was 5k and walking 5ks every 4th of Jul. He would compete. He prepared for this 90 birthday/ His goal was to do a 5k in under 60 minutes. He worked out like always , and played tennis 3 days a week to prepare. He also played ball. He likes to walk run 2-3 miles most days. He did his 5k in 52minutes, and he was celebrating. Then ten days later this all started happening. The patient/caller has been tested for COVID, and it was negative. The aches and pains were moving around. He was still having breathing difficulties. Sometimes he can't talk because of the breathing. It just goes away. If it is something like the tumor or a node on the trachea wouldn't it be happening all the time? Sometimes he can't talk because the breathing is bad. It comes and goes. It is more often recently. It is like all the sudden he can't breath and can't talk. That started right at the beginning. It has gotten progressively worse. He took Tylenol to help the pain in his body. Nothing has helped his breathing. He tried antihistamines to see if maybe it was hay fever or something , but there was no difference. He didn't know where to go from here. He was feeling horrible. He was just waiting on 26 May2021, for the second scan without color of thorax to see those results. The patient said he didn't have questions. The outcome of events was unknown.

patient presented to emergency department 7/1/2021 with flu-like illness for approximately 1 week. He had fever, chills and cough. Requiring O2 at 2-3 LPM. Treating with dexamethasone 6mg daily, supplemental O2 and SQ heparin for VTE prophylaxis.

RECEIVED COVID VACCINES ON 01/20/21 AND 02/10/21. 2/11/21 EMS CALLED BY FAMILY FOR ALTERED MENTAL STATUS AND ACCUCHECK OF 40 AND TAKEN TO ER HAD NEGATIVE COVID PCR ON 02/11/21 DIAGNOSED IN ER ADMITTED TO HOSPITAL INPATIENT WITH HYPOGLYCEMIA DUE TO DMII, AMS, UTI, AND PLEURAL EFFUSION

1 day after shot pt developed grogginess, chills in the evening, and the next morning, 2 days later scarlet red rash appeared on bilateral legs, left worse than right, ongoing, evaluated for possible cellulitis, versus vasculitis (elevated CRP), and venous stasis dermatitis, versus drug eruption (as he was placed on augmentin). seen at acute care, local dermatology and ER within 6 days. Rash abating and now followed by extensive lower extremity swelling.

91 y.o. Male with diabetes, pacemaker, hypertension, history of DVT on anticoagulation, who had his second dose of Covid vaccine on 2/17. After that, he experienced left arm swelling then developed a diffuse rash on his trunk and groin, and went to urgent care on 2/25 at that time noting blisters forming in multiple areas. At that time he was started on a 10-day prednisone taper from 40 mg down and referred to dermatology. However, he then came to the ED on 3/13 complaining of worsening of this blistering rash he described as itchy, not painful, and not associated with fevers or chills. Per his daughter he was mildly confused and complaining of fatigue. In the ED, he was afebrile with normal vital signs. WBC 13.4 with neutrophil predominance, mild anemia, acute kidney injury with creatinine of 1.7, CRP 16, lactate 2.1, Covid PCR negative. No imaging was done. Blood cultures were obtained but no antibiotics were started. He was started on high-dose Solu-Medrol and topical steroids and antihistamines as well. ID consult requested for further recommendations.

Face turned extremely red. Right eye almost swelled shut, nose, lips, ear swelled and very red on Friday, March 5, 2021. Swelling began to subside somewhat on Monday, March 6 after taking Benadryl.

Patient was seen and examined at the bedside. The patient is a 91 yr/o male with a history of CHF, NSVT, aortic stenosis, atrial fibrillation, HTN, hypothyroidism, DM2 who presents to the emergency room with complaints of chest pain and worsening shortness of breath. He reports he got his second Covid vaccine yesterday and was feeling well until about 1 AM when he woke up acutely short of breath. His wife checked his oxygen and reports he was 90% on his home 2 L. He felt he could not breathe unless he was sitting straight up. He changed over to his CPAP and was able to breathe and fall asleep comfortably. Today throughout the day his shortness of breath has persisted and he was due to see his cardiologist so they went to his appointment. While at the appointment he developed substernal chest pressure. It did not radiate. It resolved with 2 sublingual nitroglycerin. Patient was transferred to the emergency room for further evaluation. Patient denies any fever or chills. He has a chronic cough with clear sputum unchanged. He reports worsening lower extremity edema over the past few days. He reports he has been taking all of his cardiac medications as prescribed. Work-up in the emergency room concerning for acute on chronic CHF exacerbation. Troponins mildly elevated but are plateaued. No further chest pain while in the emergency room. Patient to be admitted for further evaluation and treatment

Immediate mid section itching and hives; Immediate mid section itching and hives; Extremely swollen left arm and hand within two days; Hives turned to water blisters; This is a spontaneous report from a contactable consumer. A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient had no medical history and no known allergies. The patient had no prior COVID vaccination, no COVID test post vaccination and no other vaccine in the last four weeks. The patient had unspecified concomitant medications for the last two weeks. The patient experienced immediate mid-section itching and hives. Extremely swollen left arm and hand within two days. Hives turned to water blisters, unaffected by prednisone. Blisters first appeared on arms, back and stomach and advanced to underarms and groin area. Hospitalization for five days was necessary. The events started on 09Feb2021. Intravenous steroids and antibiotics were given as treatment. The second dose of BNT162B2 was given on 18Feb2021 11:00 on the left arm. The outcome of the events was recovered. Information on the lot/batch number has been requested.

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.

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.

Patient had two ED visits 3/9/21 and 3/11/21, then presented to the ED on 3/28/21 where he was subsequently hospitalized with severe sepsis.

92 y.o. male patient with past medical history of Factor V with history of pulmonary embolism who presented with shortness of breath and cough. He was vaccinated for COVID-19 with his first shot on 2/3 followed by 2/27 with the Pfizer vaccine. He reported his symptoms started on 4/3. Family members including wife (also vaccinated) all had similar symptoms, they had all tested positive for COVID-19 on 4/6. He reports having diarrhea, nausea, shortness of breath and cough. No chest pain. Work up in the ED revealed a WBC of 16.1 and infiltrates on CXR. Patient is admitted to hospital starting 4/9/21 and currently still here as of today 4/30/21.

right arm swelling immediately after injection. followed by bilateral lower leg edema, chills and body aches that continued daily at 2 weeks post immunization admin 2/4/21 treated with dexamethasone 6mg PO x 7 days- this resolved his s/s 2/13/21 patient passed away at facility

Cause of death is believed to be a fatal arrhythmia resulting from advanced old age and aggravated by sepsis due to COVID-19 infection along with gastroenteritis. The death was natural and not unexpected. Tobacco is not believed to have contributed to t

shingles in his forehead and close to his eye but not in eye; lesions; swelling, pain and inflammation; swelling, pain and inflammation; swelling, pain and inflammation; This is a spontaneous report from a contactable consumer. A 93-year-old male patient received the first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number: EL3302), via unspecified route of administration on 22Jan2021 at 14:00 (at the age of 93-years-old) as a single dose for COVID-19 immunisation. It was reported that patient had a lot of medical conditions and takes a lot of medications (unspecified) (but nothing she thinks is related to the vaccine). Additional vaccines administered on same date of the pfizer suspect was none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 07Feb2021 patient had lesions showed up and he was diagnosed with shingles he had symptoms 2-3 days prior: he was on a medical treatment with a viral medication, prednisone, ibuprofen and Tylenol. On Tuesday they went to see his ophthalmologist because he has shingles in his forehead and close to his eye but not in eye, his ophthalmologist said that after 10 days with the viral medication and 5 days with prednisone, he should be able to get the second dose of the vaccine. She would like to know if the vaccine could have caused him shingles. He was on a viral medication and was put on prednisone for swelling and inflammation on an unknown date in Feb2021. The patient was also alternating Tylenol and Advil for pain. The patient did not visit emergency room. The outcome of the events lesions, swelling, pain and inflammation was unknown while for shingles was not recovered.

ED to Hosp-Admission Discharged 3/31/2021 - 4/12/2021 (12 days) Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Date: 4/12/2021 DOB: 1/13/1928 Admission Date: 3/31/2021 MRN: 000452141 Length of stay: 12 Days Admission diagnosis: POA * (Principal) Pneumonia due to COVID-19 virus Yes HPI: Patient is an 93 y.o. male presenting to ED on 3/31/21 with worsening shortness of breath with fever occasional cough, and fatigue. He just received his second dose of his covid vaccination 3//26. Hospital Course: Patient was admitted to receive treatment for COVID 19 infection. On presentation he was hypoxic requiring supplemental oxygen, he was in Afib RVR. He received experimental treatment with plasma, remdesivir, and dexamethasone. He had a AKI in setting of infection that improved, and his lasix was added back. He has CKD3, would recommend re-check cr in 3 days after discharge. He did develop acute urinary retention that required a foley to be placed. Void trail in hospital was unsuccessful, suspect relatedd to weakness/poor endurance. Can considner ongoing voiding trails as his health improves and or outpatient urology consult. Paroxysmal Afib in the setting of viral infection, with fluids and increasing metoprolol rates improved. Once he recovers from Afib can consider MCOT to evaluate Afib burden, continue ASA Covid pneumonia Acute hypoxic respiratory failure, from COVID Pneumonia Received convalescent plasma Received Dexamethasone 10 day course Completed remdesivir 5-day course on 4/4/21 Oxygen Requirement continues at 2 L nasal cannula Inflammatory markers trended down He was vaccinated SECOND INJECTION on 3/26. Acute kidney injury on chronic kidney disease stage IV Creatinine improved with IVF did upwardly trend again likley from acute urine retention Cautiously watch Cr while on Lasix, consider checking CR/BUN in 3 days Monitor creatinine, avoid nephrotoxins Discharged with foley, continue Flomax. Consider voiding trails at SNF and/or urology consult Paroxysmal atrial fibrillation -new onset Metoprolol tartrate increased during hospitalization patient will benefit from outpatient event monitor to determine A. fib burden once he recovers from Covid, to be arranged by PCP continue aspirin

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.

Admitted to hospital on 2/24/21 with shortness of breath, lower extremity edema, coagulopathy. Hx of CHF. COVID test negative

L hand edema, hematoma which burst and caused bleeding sending pt to the ER for pressure dressing and 2 stitches. L hand and arm progressively got more edematous and bruised looking (severely black/blue/purple) and the hand continued to bleed and swell on 2/6/21. Severe arterial and venous issues and apparent blood clots. On 2/7/21 there were also lumps noted on left inner thigh. Pt. stopped eating or drinking on 2/8/21 and expired on 2/12/21.

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

Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 95 and admitted to ED on 2/26/21 with leg edema and diarrhea. Had periods of bradycardia in the 40s during admission. Diagnosis was heart failure exacerbation which caused a significant decline in his condition resulting in eventual palliative care before his death. Notable comorbidities include CAD s/p cabg, T2DM, HFrEF, CKD, HTN, recurrent UTIs.

Major Complex Seizure with post-ictal period of 2 hours, occurring 3 hours after receiving injection. 16 days later on March 6, 2021 was unable to void, sustained breathing difficulty with peripheral edema. Received diuretic from Nurse,. Indwelling Catheter was inserted. On day 17, after receiving Corvid Vaccine, DECEASED on March 7, 2021 at home. Sustained Complex Seizure 6 hours prior. Death Certificate ruling Cause of Death as Cardiac Arrhythmias.