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.

Presented with stroke like symptoms at 10:30, right sided weakness and slurred speach. 911 was call, patient was transported to hospital. Per ED note, patient experienced TIA which resolved, actue exacerbation of CHF. Patient was admitted. Discharge summary on 1/22 indicates same diagnosis, plan was home with hospice. Family notified hospital on 1/25 that patient had expired on 1/23 at home.

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.

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.

Systemic: Other- paralysis. Stroke ruled out at Emergency room. symptoms lasted 2 days and began morning after immunization

pain in upper arm on first two-3 days, then moving to left hip area for 2-3 days, then moving also to left knee and leg.

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

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.

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

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

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

Bilateral lower extremity weakness and numbness presenting 1 week after his second dose of the vaccination. He was found to have a longitudinally extensive transverse myelitis and intramedullary hemorrhage. He unfortunately has not had any recovery of his lower extremities

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.

Extreme hoarseness; This is a spontaneous report from a contactable consumer (patient's child). A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on the left arm on 27Feb2021 12:00 (Batch/Lot number was not reported) at the age of 90 years old as 2nd dose, single for COVID-19 immunisation. Medical history included Chronic lymphocytic leukemia. The patient had no known allergies. Concomitant medications included vitamin B complex (VITAMIN B); omeprazole; and losartan potassium; all were reported as medications in two weeks. The patient previously had the first dose of BNT162B2, via an unspecified route of administration on the left arm on 30Jan2021 12:00 (Batch/lot number not reported) at the age of 90 years old as 1st dose, single for COVID-19 immunisation. The patient didn't have COVID prior to vaccination. The patient hadn't been tested post vaccination. On 28Feb2021 08:00 the patient experienced extreme hoarseness which resulted in doctor or other healthcare professional office/clinic visit. The patient didn't receive treatment for the event. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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.

Resident admitted to Hospital on 6/29/2021 for hemiplegia. Diagnosed with a cerebral infarct. Resulting aphasia and right hemiplegia.

SUSPECTED CVA; BRADYCARDIA; FACIAL DROOP; SLURRED SPEECH; WEAKNESS; DYSARTHRIA; ALTERED MENTAL STATUS; HYPERTENSION;HYPOKALEMIA; ISCHEMIC CARDIOMYOPATHY; LEFT BRANCH BUNDLE BLOCK; RHEUMATOID ARTHRITIS; RIGHT SIDED WEAKNESS; TYPE 2 DIABETES MELLITUS WITH DIABETIC NEUROPATHY STARTED ON 7/4/21 AND PATIENT WAS HOSPITALIZED UNTIL 7/8/21. CARDIAC ARREST; ACUTE ENCEPHALOPATHY; ALTERED MENTAL STATUS STARTED ON 7/9/21 AND PATIENT WAS HOSPITALIZED UNTIL 7/12/21.

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.

Slight sore arm; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration from 02Jan2021 09:45 at single dose for Covid-19 immunization. The patient medical history included heart issues. Concomitant medications were not reported. The patient has received other unspecified medications in two weeks. The patient previously took Penecillon and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced slight sore arm on 02Jan2021 (15:45). There was no treatment received for the adverse event. The outcome of event was recovered on an unspecified date. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious.

Patients wife called for help and said he seemed to be asleep. Staff helped hold him up so he did not fall out of his walker. He did have a pulse and appeared to be breathing. We removed his mask to make sure airway was not blocked. He was not responsive to verbal or physical cues. 911 was called. Patient was laid on ground and had bp checked by emergency services. He did wake up but was taken to hospital.

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.

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.

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

Narrative: Per ER MD: "2nd dose of covid vaccine today then went home. His family found him unresponsive and started CPR and he woke up."

DIAGNOSIS: #1. CVA #2. Aphasia, acute Number 3. Change in mental status, acute ASSESSMENT/PLAN/DECISION MAKING: Spoke with radiologist informed me that patient had a deep ischemic or infarct change in his corona radiata area which is common in patients with covid 19 infection or vaccination, which patient had a day and a half ago after lengthy discussion with wife, she informed me that patient would not want CPR and he had a stroke in the past and does not want to go to another city as he is 91 years old and therefore not a candidate for thrombolysis and also this was a wakeup stroke and so we do not know his exact time of onset, and she states that they simply want to be treated here for comfort care.

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.

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

Only received 1st round dosage of COVID vaccination, he seemed to handle vaccination okay. On January 17, 2021, he tested COVID positive on a resident screening test done in response to an employee positive case in days previous to the residents testing. Fifteen days after his first innoculation,his AM nurse found him non-responsive on early vital checks. Vitals at that time were normal range. The facility physician was contacted and advised that he should be taken to Emergency Room at local hospital for further evaluation. Blood work was taken and ER DR diagnosed Heart enzymes elevated indicating a heart attack. Advised additional testing should be done, and that monoclonal antibody treatment wasn't an option due to time lapse since diagnosis of COVID, The option of comfort care was chosen as the treatment plan.

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

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.

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.

stroke with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021; right arm, soreness in arm; neck and shoulder pain began along with weakness in right arm; neck and shoulder pain began along with weakness in right arm; neck and shoulder pain began along with weakness in right arm/ with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021; General body weakness; This is a spontaneous report received from a contactable consumer (patient). A 91-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 91-year-old, via an unspecified route of administration, administered in arm right on 18Feb2021 at single dose for COVID-19 immunisation. Medical history included arthritis. Known allergies: amoxicillin. Concomitant medication included verapamil HCL; furosemide, potassium chloride (LASIX + K); colecalciferol (VIT.D3); magnesium oxide (MAGOX); atorvastatin calcium; warfarin. The patient previously received the first dose of BNT162B2 on 28Jan2021 at the age of 91-year-old for COVID-19 Immunisation, no issues whatsoever. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced stroke with worse deficiency in right arm-weak, very little use in arm/hand as of 21May2021 on 24Feb2021 02:00, right arm, soreness in arm on 21Feb2021 , neck and shoulder pain began along with weakness in right arm on 21Feb2021, general body weakness on 21Feb2021. Adverse events resulted in emergency room/department or urgent care, hospitalization (in 2021 for 3 days), life threatening, disability or permanent damage. It was unknown whether treatment received for the events. The patient underwent lab tests and procedures which included Covid test type post vaccination: blood test: negative in 2021. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

After the first dose my father got what the eye doctor thought was pink eye. After treating him it didn't clear up. It was later diagnosed as herpes of the eye and he became blind in one eye. Shortly afterwards I read an article from researchers who stated they had found fragments of the herpes virus in the vaccine. After the second vaccine he was fine one day and 2 days later started having seizures. He was hospitalized for the seizures. His personality totally changed. He no longer recognized my sister. He also became hostile which is not the person he was. He was released from the hospital and brought to a new facility. Then the lights went out. he just stared off into space. A day later he was dead.

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.

legs hurting; This is a spontaneous report from a contactable consumer. A 92-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 vaccination. Calling on behalf of 92-year-old uncle received first dose of vaccine. The patient's medical history and concomitant medications were not reported. The patient had complaining of legs hurting on an unspecified date. The outcome of the event was unknown. Information on the lot/batch number has been requested.

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

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

Ischemic stroke on Saturday morning following vaccine Thursday. Symptoms were muscle weakness and inability to speak

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.

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

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

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

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.

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

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.

Patient was a well and active 92 year old man, who walked 2 miles daily with a walker. He received Covid vaccine dose 1 on 11 Jan. On or before 30 Jan, he noted pains in one leg while walking. Newly dilated veins on the lower leg were noted. On feb 2 a doppler US revealed a superficial saphenous vein venous thrombosis, also new onset A flutter. Aspirin begun. On Feb 5 he woke with a cold foot (same side) and was found to have an arterial thrombus from SFA through distal posterial tibial. He underwent emergency thrombectomy, went to rehab for recovery, on Feb 23 suffered intracranial hemorrhage and died on Mar 10.

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.

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.

Resident noted with left eye drooping on 1/26/21. On 1/27/21, resident has left eye and mouth drooping.

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

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

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

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

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

Pt reported sudden onset of shortness of breath and general weakness. symptoms resolved in less than 5 minutes with no treatment. BP 126/74, HR 76 strong and regular, RR 16, Skin PWD. PT denied further treatment.

seizure; unresponsive for 20 minutes; This is a spontaneous report from a contactable physician reporting for himself. A 93-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 10Feb2021 at 15:45 (at the age of 93 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included dementia from an unknown date. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 (at the age of 93 years old) as a single dose in the deltoid right for COVID-19 IMMUNIZATION. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included atorvastatin and levothyroxine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021 at 13:30, the patient experienced a seizure and was unresponsive for 20 minutes. Treatment for the events included careful observation and airway protection. The outcome of the events seizure and unresponsive was recovered on an unspecified date in Feb2021. Since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Seizure and Unresponsive to stimuli cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

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.

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

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

A few days after receiving vaccine in left arm he developed pain left shoulder and left side of neck. This has persisted and worsened. Doctor cannot find any explanation. No apparent swollen lymph nodes.

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.

Vaccine 1/14, 2/4. Admit 4/8. treated w/ steroids, zinc, antibiotics. Many comorbidities, acute encephalopathy possibly d/t COVID-19. DCd home.

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.

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.

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

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.

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

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.

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.

presented to reporting personnel facility ED from assisted living facility with weakness approximately 48 hours post vaccine. previously ambulated with seated walker but too weak to do so at time of presentation. Recovered in ED- returned to assisted living facility

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

Pt is 94 yo male with PMH of afib not on anticoagulation, BPH, OA on chronic opioids, and depression. He presented to this institution on 4/19 with aphasia and confusion, concern for stroke. MRI showed no signs of stroke and at discharge 5 days later he was back to baseline. Pt underwent standard inpatient COVID-19 testing: rapid test was positive on 4/19, then PCR test was negative on 4/20. Patient is s/p Pfizer vaccine with his first dose on 1/20 and second dose on 2/10. He was asymptomatic, with no hypoxia and did not starts steroids nor remdesivir. Team decided that presentation is most consistent with false positive, but per ID and epidemiology, pt must remain in isolation for 10 days as a precaution.

Paralyzed vocal cord. F/u with EENT -> confirmed vocal cord paralyzed. X-Rays done -> unknown. Now speaks only in whispers. f/u with Cancer Center re: possibility that vocal cord issue secondary to radiation -> indicated too long after end of radiation to have cause paralyzation of vocal cord.

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

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.

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.

My arm is little sore; This is a spontaneous report from a contactable consumer reporting for himself. A 95-years-old male patient received BNT162B2 Pfizer-BioNTech COVID-19 Vaccine, via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient also received apixaban (ELIQUIS), 2 dose forms (DF) every day, via an unspecified route of administration from an unspecified date at an unknown dose as blood thinner. Medical history included a bone spur in the left foot that causes the patient to limp a bit, although he is still able to move around a little bit ("he is surprised that he is still plodding along"), cardiac pacemaker insertion, body weight sometimes increasing, a trouble with his vision, so he has a restricted driver's license: he can only drive during the day time. The patient is also a hearing aid user from an unknown date and has central nervous system stimulation from an unknown date ("I have Neuraxis"). His wife says that "he has them every day". Past drug history included warfarin sodium (COUMADIN) used for years as blood thinner. The patient's concomitant medications were not reported, although the patient stated he takes a lot of medications. The patient reported that the vaccine "worked beautifully", but only after the shot he could read on the information sheet that the he should have told the provider about all his medical conditions, if he has a bleeding disorder or is on a blood thinner. Now he's reluctant to take his pills because of this warning. He feels fine, he doesn't have any problems with the shot. He only stated that his arm was little sore but that's to be expected. The patient would like to know if he can continue to take his blood thinner. On an unknown date the patient underwent lab tests connected with some kind of surgery or his pacemaker whose results were unknown. The action taken with apixaban in response to the event was unknown. The event outcome was unknown at the time of the report. 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.

Patient continued to deteriorate after second dose of vaccine with progressive weakness and shortness of breath. When he presented to the emergency room he had new onset cardiomegaly and heart failure. Patient also developed new onset atrial flutter but had bradycardia due to AV heart block.

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

Within 5 min of injection on 01/16/2021, had slight tongue swelling and tingling feeling in chest and abdomen. Headed to ER but symptoms began to subside within 20 minutes so did NOT go to to ER. Symptoms never recurred so went home and monitored. Never needed epi pen. NO further problems other than slightly sore arm.

tongue began to swell; had a tingling feeling in chest and abdomen; Slightly sore arm; This is a spontaneous report from a contactable consumer. A 96-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, lot/batch number: EL898), via an unspecified route of administration on the right arm on 16Jan2021 12:30 at SINGLE DOSE for COVID-19 immunization at the pharmacy or drug store. Medical history included hypertension, glaucoma, benign prostatic hyperplasia (BPH), skin cancer, gout, and malaria (three times experienced). The patient had also allergies with wasp stings which later manifested of anaphylactic. Patient had unspecified concomitant medications. The patient received vaccine on 16Jan2021 at approximately 12:30 pm. Within 5 minutes (12:35), the tongue began to swell, and patient had a tingling feeling in chest and abdomen. The patient also had slightly sore arm. The patient drove towards emergency room (ER) but within 20 minutes the symptoms had subsided enough to not go to ER and head home. The patient was not diagnosed with COVID-19 prior and since vaccination. No treatment was received for the events. Symptoms disappeared on unknown date in Jan2021 and never recurred.

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

Patient's daughter reported that the day after vaccination, patient had facial droop, some slurred speech, and her legs hurt/were week. This resolved on it's own, and it does not sound like they sought treatment for this.

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

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

5/3/21 this gentleman reported several days of Left lower leg pain. Ultrasound completed positive for left lower leg DVT. Pt was on chronic Coumadin therapy at that time with therapeutic PT/INR 2.7. Symptoms progressed and ongoing despite initiation of Eliquis. On 6/8/21 he underwent placement of IVC filter to protect from further clotting injury.

Systemic: Approximately 1 hr after injection 98 y/o pt became unresponsive. He had a strong pulse, cold extremeties. Did not admin epi. Nurse director felt it was coincidental to injection (hydration/nutrition)-Severe

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

About 5 days after second dose he developed a red rash.. blotchy. Then a few days later he was very weak, especially his hands and had difficulty swallowing. Today the rash developed liquid filled pustules.

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

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

100 year old patient in reasonable health (reading, socializing, doing Zoom calls, etc.) took second Pfizer vaccine on February 5, 2021. On the morning of February 22, 2021 the patient suffered a major hemorrhagic stroke. He suffered severe paralysis, could not speak, and suffered from severe pain. Within 24 hours he was moved to Hospice Care. A day later on February 24, 2021 he died.

Adverse reaction to the vaccine started with variable weakness beginning 1/29/2021. On 1/30/21 around 8:30pm, he needed assistance in the bathroom related to weakness and had what was later identified as a stroke with left side weakness and slurred speech. In accordance with his wishes, he had care at home. Due to his advanced age and frailty, a CT scan was not pursued. The 325 mg of aspirin that he was previously taking daily was discontinued. After the stroke, he needed total care. Hospice was established at home. Nursing assistant care was delivered by daughter. Death followed 9 days later (2/9/2021).

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.