Pfizer

Lethargy, chills, shaking, pale, slightly tachycardic. Afebrile initially then fever presented after about an hour to 103.3

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.

fever of 99.4; feeling kind of rotten; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received bnt162b2 on 14Jan2021 10:00 am first dose intramuscularly on left arm at single dose for Covid-19 immunization. Vaccination Facility Type was Health Department. Vaccine Administered not at Military Facility. Medical history included ongoing Congestive heart failure diagnosed a few weeks ago and had covid in Apr2020. Concomitant medications were none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations: reaction with pneumonia vaccine, could not use his arm for a few days and they told him that was normal. She does not know the name of the vaccine she thinks it was the pneumococcal and does not have lot, ndc, or expiration. She is wondering if it is normal to not have side effects till two days after. She is calling for a male that is 90 years old and cannot hear very well. States he got the vaccine on Thursday (14Jan2021) and he has a fever of 99.4 degrees, she clarified this is one day later (15Jan2021), not two days later. He was feeling kind of rotten all day and he just realized about 30 minutes ago that he had a fever. He had covid in Apr2020. Doctor thinks he is a long hauler. He did not have heart trouble before covid and now he has congestive failure which was diagnosed a few weeks ago. Adverse events not require a visit to Emergency Room or Physician Office. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Abnormal chest x-ray; Altered mental status, unspecified altered mental status type; Arrhythmia; Bradycardia; CHF (congestive heart failure); Cardiac arrhythmia, unspecified cardiac arrhythmia type; Essential hypertension; Heart failure with preserved ejection fraction, unspecified HF chronicity; Hypothermia, initial encounter; Pneumonia of right middle lobe due to infectious organism; Right middle lobe pneumonia

ON 1/28/21, REPORTED FEELING WEAK, WITH LOW GRADE FEVER AND CHILLS. STILL FELT WEAK ON 1/29 AND 1/30. EVENING OF 1/30 HE WAS FOUND IN HIS APARTMENT FEELING WEAK AND WITH SHORTNESS OF BREATH. WAS TRANSPORTED TO MEDICAL CENTER BY AMBULANCE AND ADMITTED FOR OBSERVATION.

He will get his second dose on 30Jun2021; Pain in the back of his neck going up towards his head; Pain in the back of his neck going up towards his head; This is a spontaneous report from a contactable consumer (patient himself). A 90-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 30Dec2020 in right arm at single dose for covid-19 immunisation. Medical history included none. Patient just took his regular medications. Caller said that he had his vaccine done on 30Dec2020 and two days ago (15Jan2021) he started to get pain in the back of his neck going up towards his head. He has had no other problems. It could be he had been sitting too long from watching TV most of the day. But he wanted to mention this. It started a little bit on Friday 15Jan2021, then a lot on Saturday 16Jan2021, and then today it started to go up towards his head. When he bended down more and moved around it would go away for a while, then come back. He would move it back and fourth and down and up. Then it would feel good. But then if he touched it, he can feel the pain. He thought it would get better. This was his first dose. He will get his second dose on 30Jun2021. Outcome of pain in the back of his neck going up towards his head was not recovered.

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

Vaccine on Jan 25, 2021 Minor seizure on Jan 31. 2021- 4:35pm talking, then staring, "blank stare", didn't recognize either daughter for about 10 minutes. Daughter did stroke tests, all normal. called 911, they saw no stroke symptoms, EKG normal. Within 15 minutes, he was coherent but lethargic. Could not remember 15 minutes prior. Did NOT take to ER. Saw cardiologist next day and then had head CT later that week.

Coughing; wheezing; shortness of breath; This is a spontaneous report from a contactable consumer. A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 90 years, first dose on 19Jan2021 09:00 (lot number: EK4176) and second dose on 09Feb2021 (lot number EL9261); via unspecified routes of administration on the left arm at single doses for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included losartan, terazosin, melatonin, glipizide, linagliptin (TRAJENTA), clopidogrel bisulfate (PLAVIX), clopidogrel bisulfate, citalopram, zinc, famotidine, amino acids nos (PROTINEX) and colecalciferol (VITAMIN D). On 20Jan2021, the patient experienced coughing, wheezing and shortness of breath. The patient was taken to the ER and put in the hospital for five days (date of hospitalization was unknown). Treatment received by the patient was unknown. Lab data includes COVID test: Unknown results on an unspecified date. The outcome of the events was recovered with sequelae on an unspecified date.

Patient began feeling ill the evening after receiving the 2nd dose of the Pfizer COVID vaccine on 3/3/21. He woke the next morning with AMS and was admitted to the ED with a fever of 103F. He was initially unresponsive to stimulus but no other symptoms. After arrival, given tylenol and ice packs placed. Awoke upon examination. Admitted for management of UTI with acute metabolic encephalopathy and need for cardiopulmonary monitoring. Discharged to SNF with no complaints on 3/8 for continued PT.

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.

Within 10 minutes my father developed shortness of breath, diaphoresis, elevated blood pressure, and elevated blood sugar. His blood sugar was 318. My father is a type ll diabetic and has never had a blood sugar over 200. His blood pressure was elevated at 160/90 and it normally runs 120/70. Symptoms resolved within about 2 hours.

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

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

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.

After the second shot, my father began coughing worse and it appeared his COPD exacerbated, as well as progression in memory loss and confusion. His oxygen levels decreased and his blood work showed low platelets, so he was admitted to hospital on March22-23. Discharged with recommendations to see hematologist. Bone marrow biopsy indicated a very rare form of leukemia (Hairy Cell ). Cancer likely not a cause of vaccine of course, but suspected low blood platelets and exacerbation of COPD?

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.

I get all sorts of pain; Fever of 101.3F; Slight shortness of breath; Confusion; Extreme fatigue and weakness.; Extreme fatigue and weakness.; This is a spontaneous report from two contactable consumers (one is the patient). This 90-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6200), via an unknown route in the left arm, on 20Feb2021 at single dose for COVID-19 immunization, administered at Public Health Clinic/(Name) facility. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9262) as single dose on 30Jan2021 for COVID-19 immunization. No other vaccine was received in four weeks. Relevant medical history included melanoma, lung cancer, peripheral neuropathy, arthritis and heart failure. Past drug history included allergy to penicillin. Relevant concomitant medications included spironolactone and bumetanide. On 22Feb2021, the patient experienced extreme fatigue and weakness, confusion and slight shortness of breath. He had fever of 101.3F five days after second dose of vaccine. The patient stated, 'I get all sorts of pain'. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was not treated for the events. The outcome of the event 'I get all sorts of pain' was unknown while the outcome of the remaining events was not recovered. No follow-up attempts are needed. No further information is expected.

tiredness; weak; This is a spontaneous report from a contactable consumer (patient). A 90-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN6198, expiration date unknown), via an unspecified route of administration on 01Mar2021, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not received Covid vaccination prior and had not tested Covid post vaccination. It was reported that, after receiving the dose of vaccine the patient experienced tiredness and was weak on 06Mar2021. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

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?

Pretty much been in bed most of the time; Body aches; Chills; Headache; Sheer exhaustion; Feels like he got hit by a Truck; This is a spontaneous report from a contactable consumer reporting for father. A 90-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm on 28Jan2021 as 1st dose, single (at the age of 90-years-old) for COVID-19 immunization. Vaccination Facility Type was reported as Clinic. Vaccine was not administered at another Facility. Patient medical history and concurrent conditions included: Ongoing prostate cancer with onset at least 15 years ago, extraction of 2 molar teeth which was done last week on an unspecified date in 2021, height shrunk. The concomitant medications included ongoing leuprorelin acetate (LUPRON) injection about every 4 months taken for prostate cancer with last dose administered last week. On 28Jan2021, patient was pretty much been in bed most of the time, had body aches, chills, headache, sheer exhaustion, felt like he got hit by a truck. The patient was administered his first dose of Pfizer COVID-19 Vaccine on 28Jan2021. The patient is normally incredibly active. He does all of his own lawn moving, snow shoveling and he still works. Starting the night of 28Jan2021 he had pretty much been in bed most of the time ever since. Most of the time since then he has had lots of body aches, chills-but no fever, headache and just sheer exhaustion. The patient went into work at the office for a couple hours Monday (01Feb2021), he pretty much slept all day Tuesday (02Feb2021). They called the patient doctor office, and the nurse gave a not real professional response to the events reported to her, that it is really common to have body aches for 2 weeks. They reported to the nurse that this is not normal for the patient. The nurse told them that this happens all the time; but advised them that if they think it is a problem to take him to the urgent care. They have not heard of people with the first Pfizer COVID-19 Vaccine being so knocked out. Some days he was ok, some days the adverse events were incredibly bad. A day before (03Feb2021) he was fine for a couple of hours, on Monday (01Feb2021) he was fine for a couple of hours. His usual statement regarding these adverse events was that he felt like he got hit by a truck. The outcome of the events was unknown. Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Around 15 minutes after receiving vaccine, patient started to stare off into space(blank stare). He was sweating, pulse was very weak, and he started to drool at the mouth. Wife kept stating that he did this at home sometimes and it was not related to the shot. Epi was administered and ambulance was called. Before ambulance arrived, patient started to respond to wife and HD personnel. EMT's evaluated him and wife did not want him to go to the hospital. EMT's agreed.

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.

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.

Tiredness; Nausea; Feeling generally unwell, wimpy; loss of strength; This is a spontaneous report from a contactable consumer (patient). A 90-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0186 and Expiration Date: unknown), via an unknown route of administration, administered in deltoid right on 21May2021 at around 14:00 (at the age of 90-years-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing congestive heart failure about 3 years ago from an unknown date. The patient concomitant medications were not reported. Patient was in the hospital several days before the vaccine for congestive heart failure and his doctor was unsure of the story on that. On 21May2021, shortly after injection patient experienced feeling generally unwell, wimpy, what he was bothering that, it would destroy his ability to do much of anything and had no opportunity for the treatment. On same day, an hour or two hours afterwards he felt tiredness, has loss of strength, barely getting around. It was worse on the day after the inoculation and now maybe slightly less, but still extremely excruciating. It was not going away. None treatment was received for this as he does not know how to do anything that's why he was calling but he was hard of hearing. At night on 21May2021, patient experienced nausea and then it went away rapidly. None treatment was received for this as he was not able to get a doctors appointment for weeks or months. Patient had not visited emergency room or physician office. Prior vaccination, patient has not received any other vaccine within 4 weeks. Outcome of events tiredness and loss of strength was unknown, feeling generally unwell, wimpy was not recovered and for nausea was recovered on 22May2021. Information on Lot/Batch number was available. Additional information has been requested.

Patient said he was feeling weak and sick. Reported problems with diabetes and hypotension in the past - blood glucose was checked using patient's machine and was 200. HR 88, BP 78/40 (family reported normal systolic is in the 80s). EMS was called and recommended transport to the ED, but patient/family refused. Symptoms reported at 1415, EMS on site at 1430 and patient left site at 1445.

Patient stated he was feeling weak and sick at 1415. Reported problems with diabetes and hypotension. Blood glucose checked using patient's own machine and was 200. EMS called at 1430, arrived at 1435. HR 88, BP 78/40 (family states usual systolic in the 80s). EMS recommended transport to the ED for IV fluids, but family refused. Patient left site at 1445.

Experienced chills starting about 3 hours after the shot , followed by a low grade fever ( 100.5 to 100.9 ) throughout the night . Fever down to normal by noon the 24th of Jan . Loss of energy on day 2 and 3 following the shot

The patient was observed to be lethargic on 1/29/21 at 1515. BP-80/50, P-75, RR-27, T-100.1. He was given a bolus of NS 150 mlx2. and Rocephin 1 gram IM.

Headache; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9261), intramuscular in left arm, on 21Jan2021 (Thursday) at 08:45, at a single dose, for COVID-19 immunization. The patient's medical history included ongoing diabetes (diabetic) diagnosed about 50 years ago (1971). The patient's concomitant medications included glipizide and insulin glargine (LANTUS), both were ongoing for diabetes. The patient previously took the first dose of BNT162B2 (Lot Number: EL3046) on 02Jan2021 around 09:00 AM for COVID-19 immunization (in right arm). The patient had no other prior vaccinations within 4 weeks. The vaccine was administered in a (public) health department facility. The patient had second dose of the Pfizer COVID-19 vaccine on Thursday (21Jan2021) and from Friday morning (22Jan2021), he started experiencing headache and he cannot get rid of it. It had been 5 days. The patient took paracetamol (TYLENOL) and it is not helping. Today (26Jan2021), the patient went to the hospital emergency room (ER) but they did not see him since the ER was so busy; he sat in ER waiting room for 6 hours and he never got waited on so he left. The patient did not have physician office visit but is going to see his doctor tomorrow (27Jan2021) for the headache. The patient had not recovered from the event.

Patient (now deceased) received 1st dose of Pfizer-BioNTech vaccine around December 21, 2020 and was noticed to be scratching, fatigued, and unresponsive by a family member on December 24, 2020. He received the second dose of the same vaccine around January 22, 2021. Pockmarks and bleeding scratch marks were noted by a family member on the patient's face prior to this second dose. On January 28, 2021 a family member was alerted that the patient was suffering from severe bullous pemphigoid- a skin condition that has never been experienced by the patient, has been reported to be related to COVID-19 viral infection, and to T-cell responses promoted by vaccines. A corticosteroid was given, but did not work. Blisters developed to the point hands had to be dressed.

Patient was not seen at our facilities prior to or after COVID-19 vaccination. Patient received first dose on 1/23/2021 and as reported by the family member, patient expired on 2/5/21. Symptoms were reported to have stared on 2/1/2021, 9 days after receiving the first dose with a drop in oxygen levels and fever. He was reported to also have a history of chronic lung disease. Patient's family member to be contacted if necessary.

Nurse did not reconstitute vial. Patient was accidentally given entire contents of vial equaling 6 doses. Patient was admitted as a precaution for observation on Saturday, 2-20-2021, due to complaint of chills. Patient was discharged on Sunday, 2-21-2021. Patient currently reports no side effects.

Emergency room HPI Patient is a 91 y.o. male who presents from nursing home with positive coronavirus a and flu A positive tests. Test was done yesterday. Patient sent to ER because of low oxygen saturation. Patient unable to answer or respond to questions. No fever or chills, no cough or shortness of breath and no complaint of pain when patient was moved around. Oxygen saturation on presentation was 89% on room air and went up to 93% on 4 L of oxygen admission: HPI: Patient is a 91 y.o. male with a history of severe dementia and severe COPD. He currently resides at Rehab. He had a routine coronavirus (COVID-19) test yesterday that was positive. Then, today he started having increasing oxygen requirement. He was not responding to his typical breathing treatments or oxygen and so they sent him in. In the ER he was found to be in some respiratory distress and did require increased oxygen concentration. Once they got him calm down, his oxygen saturation state over 90% with 4 L. His ABG did show an oxygen Saturation of 86% on 4 L. The patient reportedly had coronavirus (COVID-19) several months ago, but then did test positive for both coronavirus (COVID-19) and influenza on rapid testing at the nursing home yesterday. The patient is being admitted due to his increasing oxygen requirement and respiratory distress

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.

Patient became acutely ill on 1/15/21 with recurrent pneumonia, treated with Augmentin. Pt became progressively worse on the next 48-72 hours, treatment goals changed to palliative-focused, and all treatments withdrawn. Patient died on 1/22/21.

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.

hallucinations; headache; hearing disturbing noises; nausea; stomach pain; diarrhea; vision became worse; This is a spontaneous report from a contactable consumer (patient himself). A 91-year-old male patient received the second (2nd) dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6200, expiration date was not reported), via an unspecified route of administration, administered in the right arm on 23Feb2021 at 12:30 PM as a single dose for COVID-19 immunization. Relevant medical history included high blood pressure, severe anemia, diabetes, vision problems/poor vision, and spinal stenosis; all from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medications included bimatoprost (LUMIGAN) and insulin aspart (NOVOLOG) with "Bd Nano," and hydrochlorothiazid; all taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient had other vaccine in four weeks, but not specified. Following the 2nd dose on 25Feb2021 at 01:00 AM, the patient suffered headache, hallucinations, hearing disturbing noises, nausea, stomach pain, and diarrhea. Additionally, he has had poor vision, but following the shot, his vision became worse. The adverse events (AE) resulted in hospitalization for 3 days on an unspecified date. It was unknown if the patient received any treatment for the events. The patient was not recovered from all the events.

Feeling unwell; nauseated; loss of appetite; sleeping; chills; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 1515), via an unspecified route of administration, administered in Arm Left on 05Feb2021 14:30 at 0.3 mL, single for covid-19 immunisation. Medical history included Congestive heart failure (CHF), Defibrillator, Diabetes, Peripheral Neuropathy, hard of hearing, Aged Macular degeneration. No Known allergies. The patient received unspecified other medications in two weeks. On 06Feb2021, the patient was feeling unwell, nauseated, loss of appetite, sleeping, chills, extreme fatigue. No treatment was received for the events. The patient did not have covid tested post vaccination. The outcome of events was recovered.

pneumonia; kidney failure; This is a spontaneous report received from a contactable consumer. A 91-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6208), parenteral in left arm on 17Mar2021 (at the age of 91-year-old) at single dose for COVID-19 immunsation. The patient's medical history included prostate cancer, heart disease, Alzheimer. The patient's concomitant medications included leuprorelin acetate (LUPRON) injection, via parenteral route of administration in location reported as stomach from 10Mar2021 for prostate cancer. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EM6203), parenteral in left arm on 24Feb2021 (at the age of 91-year-old) at single dose for COVID-19 immunisation. It was reported that patient began feeling sick after injection. He progressively worsened and he was admitted to the hospital on 31Mar2021 with pneumonia and kidney failure. He was put on a ventilator and received dialysis along with antibiotics. Adverse events start date was reported as 18Mar2021. Adverse events were reported as serious as resulted in emergency room/department or urgent care, hospitalization, and life-threatening illness (immediate risk of death from the event). The number of days of hospitalization was reported as 6. Adverse events treatment was reported as ventilator, dialysis, and medications. The patient underwent lab tests and procedure which included COVID test post vaccination (unknown) on 31Mar2021. The outcome of the events was not resolved.

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

Patient tested positive for COVID 19 by PCR on 4/15/21; >2 weeks after 2nd dose Symptoms started 4/3/21; now w/ SOB w/ exertion, cough, chills, diarrhea, fatigue, chest pain/tightness, fever.

Felt a little off; Pneumonia; 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 and expiration date not reported) via an unspecified route of administration, administered on the left arm on 16Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history included deaf. Concomitant medications were not reported. Reporter stated that a week and a half after his first vaccine he had pneumonia (Mar2021); but that they didn't think it was related to the vaccine. The patient also felt a little off on 16Mar2021 and required a visit to the emergency room and physician office. The facility where the vaccine was administered was in a clinic. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no family medical history relevant to events and no relevant tests done. Outcome of the event pneumonia was unknown while not recovered for the other event. The reporter mentioned that they didn't think that pneumonia was related to the vaccine. Information about the Lot/batch number has been requested.; Sender's Comments: Based on available information, pneumonia is assessed as unrelated to BNT162B2, this is an intercurrent medical condition. Potential contributors include patient's advanced age as the risk for infections is higher in this population. Case will be reassessed if additional information is received

tiredness and weakness in his legs and arms; tiredness and weakness in his legs and arms; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 91-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on 09Apr2021 (at the age of 91-years-old) as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. On an unspecified date (about 3-4 days after the vaccine) patient experienced tiredness and weakness in his legs and arms (that continues). Reporter wanted to know that for how long the symptoms might last and if her husband should receive the second Pfizer Covid 19 Vaccine. Reporter also wanted to know if Lipitor, Lisinopril, Metoprolol, Nexium and Aspirin might interfere with Pfizer Covid 19 Vaccine. The outcome of events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

The resident developed COVID 19 Symptoms on 4/27/2021 and tested Positive for COVID 19 through POC and PCR testing. Congestion and Diarrhea were the main symptoms.

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.

Patient admitted to hospital on 03/24/2021 for high fever and shortness of breath; these symptoms began in 3/17. Patient tested positive for COVID-19 on 03/21/2021 and again on 03/24/2021 despite being fully vaccinated against COVID-19. Patient died on 04/19/2021. COVID-19 is listed on the death certificate. Death Certificate Information: Part I Cause of Death: A. Acute Hypoxic Respiratory Failure B. Suspected pulmonary embolism Part II: Significant Other Conditions: COVID 19 subacutely

Patient developed shortness of breath, fever, chills and was diagnosed COVID positive on July 3, 2021. Patient was admitted to hospital and received tocilizumab and remdesivir. He received dexamethasone however this caused him hallucinations. He initially required oxygen however he was weaned off to roomair. He did receive antibiotics for possible pneumonia which he has now completed. Patient also takes Coumadin for atrial fibrillation. On 7/12, he transitioned another Hospital for swing bed for reconditioning. He was ultimately discharged to home to his nursing facility on 7/17.

91 y/o male, BMI 38, PMHx CHF, dementia, HTN, and paroxysmal Afib, admitted for acute onset altered mental status, SOB, Covid19, and pulmonary edema on 4/12/21. No reports of fever but tested positive for Covid19. Chest x-ray presents cardiomegaly with bibasilar opacities suggesting atelectasis and/or pneumonia. Covid treated with supportive care. Discharged home with hospice on 4/14/21.

Patient stated he wasn't feeling well on January 25, 2021, wasn't eating and complained of abdominal pain. Patient noted to have indigestion and was constipated. Meds provided and labs ordered. On morning of January 26, 2021, patient became weak, lethargic and hypoxic and was sent to emergency department around 0700 hours on January 26, 2021. At approximately 1100 hours, emergency physician notified this writer that patient was not going to overcome his illness and would be placed on comfort care. At approximately 1130 hours, this writer was notified that patient had passed away from multi-organ failure.

Client tested positive for COVID-19 by rapid test on 1/8/21. On 1/9/21 at 1405 his oxygen saturation dropped to 86% and oxygen was initiated at 2L per nasal cannula. A non-productive cough was noted on 1/10/21 and oxygen was increased to 3L. On 1/12/21 Client became non-responsive with 30 second periods of apnea. Dexamethasone was initiated on 1/13/21. Lung sounds were noted with crackles on 1/15/21 at 1158 and at 2120 Client was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated.

Patient got the injection and quickly developed a fever and felt weak. Family was contacted and he was sent to Hospital.

Patient came to our ED on 2/6/2021 with worsening weakness and fatigue, which he claimed that had been experiencing since the date of vaccination on 1/26/2021. His rapid COVID test came back positive. He was admitted and treated in our COVID unit. His condition improved and he was discharged to home on room air on 2/10/2021.

Experienced coughing and vomiting during post vaccination observation period. Slightly elevated BP and pulse oximetry 90% on room air. Transported to ED, at triage stated feeling better, no further nausea or vomiting. Pt left ED before receiving an care. Telephone call to home, wife reported pt feeling fine, no issues.

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.

Pt received both doses of the Pfizer COVID-19 vaccine, on 2/2/2021 and 2/23/2021. Pt then developed fatigue and sore throat, was tested by PCP for COVID-19 via PCR on 3/3 and was positive. Pt was given Bamlanivimab on 3/4 due to risk factors for severe COVID, but symptoms did not worsen and pt was never hospitalized.

pneumonia; urinary tract infection; Shortness of breath; Currently critically ill; This is a spontaneous report from a contactable consumer reporting for himself. A 92-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6203/expiration date: not provided), via an unspecified route of administration, on 03Mar2021 at 10:00 (at the age of 92 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included congestive heart failure, pace-maker to treat congestive heart failure, ongoing and consistent treatment for high cholesterol, high blood pressure, and shell fish allergy. Concomitant medication included levotyroxine, atrovastatine, amniodarone, and wafarin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Mar2021 at 04:15, the patient experienced shortness of breath and needed to be hospitalized with pneumonia and urinary tract infection. The patient was currently critically ill. The events required an emergency room visit and hospitalization. It was unknown if any treatment was received. The outcome of the events shortness of breath, pneumonia, urinary tract infection, and ill was unknown. Since the vaccination, the patient had been tested for COVID-19 on 06Mar2021, with a negative result.

he is shrinking now; He collapse while he was in the shower; weak/been getting weaker and weaker; feeling more unwell every day; This is a spontaneous report from a contactable consumer. A 92-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm (also reported as left upper arm) on 05Mar2021 as single dose for COVID-19 immunisation. Medical history included Kidney cancer, bladder cancer, colon cancer, mantle cell lymphoma and was compromised health-wise. Concomitant medications included amlodipine, atorvastatin, losartan, sotalol, terazosin, and warfarin. On 08Mar2021, the patient was weak and feeling more unwell every day. On 09Mar2021, the patient collapse while he was in the shower. The wife of the patient reported regarding some possible side effects for her husband. He had been weak but on 09Mar2021, he collapse while he was in the shower and that was pretty dramatic but he has been getting weaker and weaker and feeling more unwell every day since 08Mar2021; at this point he was literally appointed for the second shot on the 26Mar2021, so wife was asking if it was advisable being he had what maybe side effects between the vaccine and his other health conditions, that he should take his second shot. On an unspecified date, the patient was shrinking now. The patient was due date for second shot on 26Mar2021. The reporter stated that the lot was EN6203, and it could be ENU203, the handwriting was very bad, and she don't know if it was U or 6. Outcome of events was unknown. Information about Lot/Batch number is requested.

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.

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.

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.

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.

The patient did not have reaction he was fully vaccinated on 2/20/21 was COVID positive on 7/14/21. The patient is reporting no fever and feeling fine. "feels like a head cold"

The resident received is vaccine around 11:00 am and tolerated it without any difficulty or immediate adverse effects. He was at therapy from 12:36 pm until 1:22 pm when he stated he was too tired and could not do anymore. The therapist took him back to his room at that time and he got into bed himself but stated his legs felt heavy. At 1:50 pm the CNA answered his call light and found he had taken himself to the bathroom. She stated that when he went to get back into the bed it was "abnormal" how he was getting into it so she assisted him. At that time he quit breathing and she called a RN into the room immediately. He was found without a pulse, respirations, or blood pressure at 1:54 pm. He was a DNR.

at about 36 hrs post vaccine developed severe chills, fatigue, confusion. Chills lasted several hours and after warming blanket and extra blankets they went away. Severe weakness lasted most of the following day until evening. Temp. under 100 degrees all day.

tired; legs felt heavy; stopped breathing; This is a spontaneous report from a Pfizer-sponsored program a non-contactable consumer. A 93-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 11:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received vaccine around 11:00 a.m. About two hours later, he said he was tired and couldn't continue with the physical therapy he was doing. He was taken back to his room, where he said his legs felt heavy. Soon after, he stopped breathing. A nurse declared a do-not-resuscitate order. The patient died on 04Jan2021. It was not reported if an autopsy was performed. Outcome of stopped breathing was fatal. Outcome of tired and legs felt heavy was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: stopped breathing

He became extremely lethargic and difficult to wake 6 hrs after receiving vaccine. Vitals were stable reported by daughter.~ 1/22/21 BP 120/72, pulse 76, O2 level 98, 1/23/21 BP124/88 P-77 O2 92 T 97.6, 1/24/21 BP 105/65 P 77, O2 88 and O2 provided per daughter. The extreme lethargy lasted for 72 hrs and had 2 hospice nurses asses for possible s/s of stroke and was told did not feel was a stroke. during this time also had "dreams" as noted by talking in his sleep a lot. Is now "slowly" coming out of sleepiness and starting to eat very little.

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.

general malaise , Fatigue, poor interest in activities , hypoactivity, pulmonary embolism Narrative: Patient transferred to ER for evaluation. Physician at facility reported marked deterioration, hypoactivity and slow mentation s/p COVID vaccine second dose 1/8/21. Cough also reported x 1 week. Patient evaluated at ER on 1/20/21 and admitted to internal medicine ward with diagnosis impression pulmonary emboli, aspiration pneumonia and urinary tract infection.

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.

Client reports he received 1st dose of COVID-19 vaccination early January, 2021, shortly after became SOB, continued for 3 weeks, worsening in the last week with increased weakness and lethargy, and received 2nd dose on 2/2/2021, and was seen by his PCP, PA Cerner on 2/3/21, sent to to the ED of Hospital was admitted for 2 days

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

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.

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.

She said after her father got his first COVID-19 Vaccine shot, in a couple days, he felt drained and had no energy/ Weakness; her father had 2-3 spells with his stomach in that he threw up; Tiredness; her father to not feel well; This is a spontaneous report from a contactable consumer (daughter). A current 94-years old male patient received bnt162b2 (BNT162B2) at the age of 93 years old, dose 1 via an unspecified route of administration, administered in Arm Right on 29Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation; lidocaine hcl via an unspecified route of administration from 2021 (Batch/Lot number was not reported) at LIDOCAINE 4 % PATCH for right shoulder trouble and right arm trouble. Medical history included Skin cancer on his one ear. The patient's concomitant medications were not reported. No Prior Vaccinations within 4 weeks. The reporter said after her father got his first covid-19 vaccine shot, in a couple days, he felt drained and had no energy, her father had 2-3 spells with his stomach in that he threw up, tiredness, weakness on 2021. She said she had checked her father's vitals signs, and his heart rate, oxygen level, and temperature are OK. She said her father had no fever. She said she didn't know if her father feeling drained was caused by the COVID-19 Vaccine shot. Reported before her father received his first COVID-19 Vaccine dose, he had trouble with his right shoulder and right arm. She said her father's doctor gave her father some patches for his right shoulder and right arm around the same time her father got his first COVID-19 Vaccine shot. She said she was not sure if either the patches, or the COVID-19 Vaccine may be causing her father to not feel well. She said the only thing she knows is that the patch has 4% Lidocaine in it. She said her father was supposed to get his second COVID-19 Vaccine dose today (19Feb2021), but was told by the Walgreens' pharmacist he had up to 6 weeks to receive the second COVID-19 Vaccine dose. She said the (name) pharmacist told her father if he was not feeling good he should wait to receive his second COVID-19 Vaccine shot. Reported her father is in good health. She said her father had skin cancer on his one ear, but other than that, her father's health has been good. She said her father had always gotten around good, and her father doesn't drink or smoke. Reported her father usually has blood work every couple months, and her father's doctor follows her father closely. No Emergency Room or Physician Office visit for the events. On 18Feb2021, her father said he felt a little better, but today (19Feb2021) her father said he felt tired and weak again. The action taken in response to the event(s) for lidocaine hcl was unknown. The outcome of the event Loss of energy, tiredness, weakness was not recovered and was unknown for the rest events. No follow-up attempts are possible, information on batch number cannot be obtained.

Received 2nd shot on April 14. He was functioning normally until he woke up on April 25. Symptoms were chest pain, trouble breathing, lethargic, very pale, cold to the touch, vomiting with blood in vomit. PT was taken to the ER where he passed away later that night.

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

ED Discharged 3/13/2021 (4 hours) Hospital ED MD Last attending ? Treatment team Weakness +1 more Clinical impression Weakness - Generalized Chief complaint ED Provider Notes MD (Resident) ? ? Emergency Medicine Cosigned by: MD at 3/28/2021 11:44 AM Expand AllCollapse All ED RESIDENT NOTE Patient: MRN: Attending: Dr. Medical Decision Making Patient is a 93-year-old male presenting to the emergency department due to weakness. He is also developed diarrhea and muscle aches over the past several days. He had an outpatient Covid test performed which came back +2 days ago. He is not experiencing any shortness of breath or chest pain. O2 sat is 96% on room air and he is currently afebrile. Lungs are clear to auscultation bilaterally. Based on his presentation I suspect patient is fatigued due to the Covid infection. Neuro exam does not reveal any focal deficits. Patient's muscle aches seem to be most consistent with his chronic arthritis pains. States that this is not really any different than usual. Will check lab work and chest x-ray to ensure patient has no other evidence of systemic infection or underlying metabolic derangements. Review of Systems Constitutional: Positive for fatigue. Negative for chills and fever. HENT: Negative for sore throat. Eyes: Negative for visual disturbance. Respiratory: Positive for cough. Negative for shortness of breath and wheezing. Cardiovascular: Negative for chest pain, palpitations and leg swelling. Gastrointestinal: Positive for diarrhea. Negative for abdominal pain, constipation, nausea and vomiting. Endocrine: Negative for cold intolerance and heat intolerance. Genitourinary: Negative for dysuria and hematuria. Musculoskeletal: Positive for myalgias. Negative for joint swelling. Skin: Negative for rash. Neurological: Negative for dizziness, light-headedness and headaches.

Starting having trouble breathing 1 week later 2 weeks later diagnosed with pneumonia 10 days later admitted to hospital with interstitial lung disease (never before diagnosed with that) Needed 24/7 oxygen Passed away May 10/21

fatigue; unable to get up on his own; heavy breathing; thick mucus; increased confusion; Weakness; severe muscle weakness; unable to sleep; aches and pains; arm was sore; This is a spontaneous report from a contactable consumer (patient's son). A 93-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261, Expiration date: Unknown) via an unspecified route of administration in the left arm on 24Jan2021 at 13:30 (at the age of 93-year-old) as 1st dose, single dose for COVID-19 immunization in hospital. Medical history included muscle relaxant, blood pressure or cholesterol and broken neck from 1978 to an unknown date and unknown if ongoing. Concomitant medications included ongoing atorvastatin calcium 10mg taken once daily by mouth for blood pressure or cholesterol taking for a while, ongoing propafenone hydrochloride 150mg taken one twice daily by mouth, taking for a while, ongoing baclofen 10mg taken one five times daily by mouth as muscle relaxant taking for years, ongoing diltiazem HCL 180mg taken once daily by mouth, taking for long time, ongoing mirtazapine 30mg taken one at bedtime by mouth, taking for a while, ongoing citalopram HBR 20mg take once daily by mouth, taking for a while. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Jan2021, the patient experienced unable to sleep, aches and pains, arm was sore, on 25Jan2021, experienced weakness, severe muscle weakness, on 26Jan2021, experienced increased confusion and on an unspecified date, experienced fatigue, unable to get up on his own, heavy breathing and thick mucus. But his father has tremendously decreased. Mentions his father was previously independent, using a walker, going to exercise class by himself and totally fine. Now after receiving the vaccine his father is unable to sleep, has aches and pains, was experiencing increased confusion and profound weakness. Adds his father can't get up on his own and has to be guided to use the walker if he can get up. They did call his HCP and were advised not to get the second dose and to make sure patient was eating and drinking. He was scheduled to receive the second dose on 14Feb2021 but he was unsure if he will get it. Adds his father had been water walking everyday and this wasn't like him. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Patient presented to the ED on 3/11/2021 for dehydration and acute kidney injury. Patient had second vaccination dose on 3/24/2021. Patient hospitalized on 5/3/2021 for hypokalemia. Patient presented to the ED on 5/6/2021 for gross hematuria. These visits are within 6 weeks of receiving covid vaccinations.

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.

Pt received both doses of the Pfizer COVID-19 vaccine, on 2/18/2021 and 3/10/2021. On 7/12/2021, pt presented to our ED for "feeling crumy" with a decline in ADLs. Pt tested positive for COVID 19 via PCR. Chest Xray positive for pneumonia, suspected UTI also contributing. Pt admitted to inpatient due to weakness and suspected underlying infection.

Received covid (Pfizer) vaccine on 2/18/21 and 3/10/21. Presented to hospital on 7/12/21 with chills, fevers, cough and weakness (symptom onset was a few days prior to admission). CXR = Right basilar airspace opacity concerning for pneumonia. No hypoxia or need for O2. Started on antibiotics for CAP and possible UTI. Urine culture showed >100K mixed skin flora. Blood cultures x2 were negative. SARS-CoV-2 PCR resulted positive.

93 Male vaccinated Pfizer 1/06/2021 & 1/28/2021. Symptom onset 4/30/2021 - SOA, fatigue. Taken to ER 5/10/2021 for blurry vision. Diagnosed with COVID 4/30/2021. Started dexamethasone. Patient claims left eye problems secondary to dexamethasone. Discharged and final diagnosis at time of death 5/24/2021 - COVID-19 with PNA

Family was told that Patient expired in his sleep during the early morning hours of 1/15. I spoke with him the evening before (on 1/14), which was a day after he had received the Covid vaccine. He was not having any symptoms of allergy or reaction then. He did say that he felt tired, but he often complained of feeling tired over time.

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.

Fatigue- started 02/02/2021 morning - currently experiencing muscle ache (shoulders and arms)- started 02/02/2021 - ended 02/06/2021. Teeth hurt when tongue touched their teeth- started 02/05/2021 - ended 02/06/2021 Headache- started 02/05/2021 - ended 02/06/2021 Chills- started 02/05/2021 - currently experiencing Fever- started 02/05/2021 - currently experiencing

Fever of 100.8. Patient's normal temperature is 97.1, and with an infection/UTI it will go up to 98.6. Patient was fine the first 48 hours after the vaccine. pfizer lot EM9809

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.

Patient became ill with pneumonia on 1/29/21 and then recurrent pneumonia on 2/10/21. Pt's plan of care was subsequently changed to comfort-focused on 2/11/21 and patient was deceased that same day.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was community acquired pneumonia.

sneezing bout; runny nose; congestion; This is a spontaneous report from a contactable consumer (patient). A 94-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9262) via an unspecified route of administration in left arm on 31Jan2021 02:15 AM as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Medical history included parkinson's disease and allergies to medications, food, or other products was reported as trees. Concomitant medications (within 2 weeks of vaccination) included carbidopa, levodopa; amiodarone; calcium carbonate (CALTRATE) and docusate sodium (COLACE). It was reported that, during the night after receiving the vaccine, patient experienced sneezing bout. The day after the vaccine very runny nose and congestion all on 01Feb2021 04:00 AM. 2 days after the vaccine nose was still runny but not as much. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not received for the adverse events. The outcome of the events was reported as recovering. Follow-up attempts are completed. No further information is expected.

4/22/2021 Tested positive for Covid-19 discovered during Universal Swabbing on Specific Unit. Resident was asymptomatic. COVID-19 screening were completed every 4 hours. 5/3/2021 COVID-19 screening revealed runny nose, declining meds and combative. Urine tea colored and foul smelling, Poor PO Intake. 5/4/2021 resident appeared uncomfortable and distressed with increased respiratory rate. Morphine and Ativan given for comfort measures. 5/5/2021 Deceased.

Increased Fatigue, Bradycardia, unable to arouse pt. Sent to emergency room, admitted for observation and testing.

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.

OX SATURATION AS LOW AS 74, TEMPERATURE OF 100.5, DYPHORETIC, SHAKING, HOT TO TOUCH, PALE, FEELS TERRIBLE COUGHING

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.

Severe Headache, Disorientation, Physical & cognitive impairment, Aphasia / Stroke-like symptoms Details: My dad has been in excellent health and lives independently. He received the Vaccine on THURSDAY, 1/14/21 at 11 pm. FRIDAY(1/15/21 at 11:45 a.m.) The following morning, I went into his home to check on him. He was sitting in his chair with his undershirt and boxers that he wore to sleep. Normally, Dad would have showered and been dressed. He was holding his head in his hands and crying. (CONT'D)

Vomiting, high fever (103.4 F.), chills, uncontrollable shaking, inability to speak coherently, leading to hospitalization for 3 days

Patient seen at my office 3/18/2021 (ambulatory). Had dose 2 on 3/19/21. The next morning around 5am (3/20), he had difficulty get to bathroom. Was holding onto the sink because his legs would not work. Family had to help him use bathroom and get him back into bed. Family got him bedside commode that day and even then had severe weakness like a "bowl of jelly". Had mild cough and neighbor listened to lungs and was clear. Cough cleared and had labored breathing intermittently. His breathing became more labored and he slept a lot and then breathing "kind of erratic" and then breathing slowed down and got slower and slower until he stopped breathing altogether. Passed on 3/21/2021.

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.

EM reported to emergency department on 3/29 with complaints of abdomianl pain, dirrhea, body aches , fatigue, weakness, hypoxia, headache and shortness of breath Admitted to Hospital 3/29 and discharged 4/1

Headache; Nausea; Eyes are bloodshot red and kind of glaze over; Eyes are bloodshot red and kind of glaze over; He just can't feel real good; This is a spontaneous report from a contactable consumer. A 96-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Jan2021 as a SINGLE DOSE for COVID-19 vaccination. Medical history included heart problems from an unknown date and unknown if ongoing, he has gone over for a battery replacement, pacemaker, and he has eye problems so, he is taking eye drops for those. Concomitant medications included unspecified eye drops. On unspecified date, the patient experienced headache, nausea and his eyes are bloodshot red and kind of glaze over. He just can't feel real good. His eyes are real red and like glaze over. No treatment was received for the events. Outcome of the events headache, nausea, eyes are bloodshot red and kind of glaze over and he just can't feel real good were unknown. Information on the lot/ batch number has been requested.

Both nipples on my chest, they hurt. I would say they are sore.; Area on the right leg itches; Does not feel well; This is a spontaneous report from a contactable consumer (patient's wife) and a non-contactable consumer (patient). A 96-year-old male patient received the second dose of BNT162B2 (BNT162B2, Solution for injection, lot number: 5L3248, expiry date: not reported), via an unspecified route of administration, on 03Feb2021 at a single dose for COVID-19 immunization. Medical history included thyroid (disorder) and triple bypass a number of years ago. Concomitant medications included apixaban (ELIQUIS), dutasteride (DUTASTERIDE), famotidine (PEPCID), fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), furosemide (FUROSEMIDE), nebivolol hydrochloride (BYSTOLIC), simvastatin (CRESTOR), and he also takes cholesterol and thyroid medicine. The patient previously received the first dose of BNT162B2 (BNT162B2, Solution for injection, lot number: EL0142, expiry date: not reported), on 12Jan2021 for COVID-19 immunization (at the age of 96-year-old). The patient reported that both of his nipples hurt and his right leg itches on 07Feb2021. He further clarified, "My wife just told you that the symptoms that I am experiencing are, both nipples that would be the both nipples on my chest, they hurt. I would say that they are sore, and I have a area on the right leg itches and that just started. All these symptoms just started. Otherwise, I am okay." The patient's wife also reported that the patient does not feel well at the time of the report. The patient did not receive any treatment for the reported adverse events. Outcome of the events was unknown.

COVID-19 infection with pneumonia: Present on admission. Patient was treated with remdesivir and convalescent plasma.

Patient tested positive for COVID 19 on 5/21/2021, then admitted to Medical Center on 5/30/2021 with worsening dyspnea, cough and fevers. Remains admitted as of 6/8/2021. Had received Pfizer vaccination at the Vaccination Center Dose #1 in February 2021 Dose #2 on 3/17/2021

COVID-19; Chronic heart failure with preserved ejection fraction; Elevated brain natriuretic peptide (BNP) level; Fatigue; Hypokalemia; Hyponatremia; Need for vaccination

Early in the shift on January 31 resident was noticed to be more tired than usual and was not eating well. Lung sounds were crackly and resident was found to be hypotensive. He was evaluated in emergency department. He was diagnosed with pneumonia. Received a loading dose of antibiotic and returned to facility.

On 01 February 2021 a 97 year old male was administered the Pfizer COVID vaccine. Side effects began as fatigue and difficulty communicating. On 08 February 2021 the male became bedridden and developed a fever with chills. Over the next few days he struggled to eat, drink, and eventually to breath. The 97 year old died 25 February 2021.

97 Male PCR positive 4/28/2021. Vaccinated with Pfizer 1/6/2021 & 1/28/2021. Hospitalized 4/28/2021- 5/6/2021 for COVID PNA & fatigue, SOA, diarrhea. Placed on Rocephin for UTI. Required more than 4L of oxygen, decreased appetite. Developed hematuria due to Pseudomonas. Transferred. Passed away 5/13/2021.

shaking with chills diarrhea for 2-3 hours upset stomach (daytime and during night, trying to sleep) headache thrashing legs during sleep

blood oxygen level dropped; chills and shaking; severe coughing; chills and shaking; profound leg weakness; This is a spontaneous report from a contactable consumer (patient). A 98-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Right arm (at age of 98-year-old) on 19Feb2021 at 12:30 PM as a single dose for COVID-19 immunisation, lot number: EL9267. Medical history included normal incident to old age. Patient had no known allergies. It was reported that patient received other medications in two weeks prior to the vaccination, no further details provided. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. On unknown date in Feb2021 at 10:30 PM patient experienced severe coughing, chills and shaking, blood oxygen level dropped, profound leg weakness. Events resulted in Doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). Patient was treated for the events, hospice was called, oxygen machine was attached. Patient was not tested for Covid post vaccination. Patient was recovering from the events, at the time of the report.

Patient was brought into the ER with weakness, confusion and decreased appetite for days after testing positive for COVID19 on 2/6. Patient's wife had a fall on 2/2, patient helped his wife and again had recurrent fall and finally took to hospital on 2/5 where she was tested positive for COVID 19 and passed away on 2/5. Patient received his first dose of COVID-19 vaccine on 1/29/2021. Patient's daughter was concerned about patient's confusion, breathing and decreased energy levels and recommended to come to hospital for evaluation. Daughter report that she noticed mild fever, cough and some diarrhea on 2/6 when she came to check on him after her mother tested positive on 2/5. She thinks he might have symptoms 1-2

Patient received COVID-19 Vaccination at about 11am. About 1.5 hours later he stated did not feel well and o2 sats had dropped to 74%. The facility employees alerted the vaccination staff as they were still in the building. Vaccination team directed staff to call 9-1-1, but patient is on hospice so they called the hospice nurse instead. Vaccination team had staff lay patient back down in bed and raise feet above heart. o2 stats rose back up to 88%. Hospice nurse arrived and sat with patient. Patient's physician was contacted. Patient had returned to baseline within 3 hours and 15 minutes of vaccination.

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.