Pfizer

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

Pt is alert and oriented with a GCS of 15. Pt able to answer questions appropriately, name, DOB and any complaints, which pt stated no complaints. Staff stated pt wasn't speaking to them prior to arrival and pt's strength and ability to move from her bed to her wheel chair and vice versa has been compromised since she received first dose of COVID vaccination on the 12th. 911 was called when it appeared she could not speak and noted her left eye was no longer staying open. Pt able to speak clearly with EMS, but noted left eye continued to stay shut. No recent trauma, no ocular hx and no changes to recent medications. Assessment documented above, stroke scale negative. Speech was excellent, symmetrical smile, negative on arm drift, good grip strength and good push and pull with feet. BG of 103. Pt is wheelchair bound but independent for transferring from chair to bed but has been on a steady decline in terms of independence and needed 1-2 person assist for a week.

Family member reported that after receving first injection patient went home and a few hours later became lethargic to the point where she did not know she had an injection, could not answer questions and could not feed herself. Patient had extreme lethargy and did fall once. This lasted 24 hours.

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

02/04/2021 2:15pm Felt Buzzed.. Energized ..Up lifted in Spirit 02/05/2021 2:00am Set up to go restroom.. slight Forehead Headache.. upon standing Dizzy unstable. Weak.. Used walk and furniture for support.. after seated on the toilet head pain increased.. Felt Nausea (did not Vomit)..headache passed.. returned to bedroom. This took 35 minutes 02/05/2021 2:35am seated on the bed.. felt Dry throat.. smelled Feverish ..Aches in Legs ..Right hand up to shoulder Stiffness(10minute duration).. 02/05/2021 3:00am felt fatigued.. feel asleep 02/05/2021 9:00am Awoke no issues.. 02/05/2021 10:30am Injection site left arm itchy.. no swelling .. no bruising.. tender to touch.. itchy sensation over full body

Approx 10-15 minutes after receiving the vaccine, client reports dizziness and lightheadedness. Vitals monitored. Client had removed her Clonidine patch the day before due to vaccine, and was instructed this was not necessary. Vitals stable, released to her son that was with her. Now c/o Headache and dizziness, but she thinks it may be related to her ear problems.

The next day, patient was found down by children (lives alone.) Was confused, had had fecal incontinence many hours earlier (dried) . Neither syncope nor fecal incontinence had occurred before. Previously managed to walk w walker or holding on, do her own basic ADLs (toilet, use microwave, eat.) Now bed bound and requires 24 hour care, unable to stand even with assistance/PT. Mental state has returned to baseline. Spent a week in rehab but could barely comply w PT instructions due to pain/dizziness.

02/18/21 0645 - non injury fall 0930 - non injury fall 1635 - Injury fall - fractured pubic bone Sent to ER -> Rehab

Vertigo and throwing up; Vertigo and throwing up; This is a spontaneous report from a contactable consumer reported for herself. A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), from lot number: EK9231 on 23Jan2021 (at the 90-year-old), at single dose for COVID-19 immunization via unspecified route of administration at the left arm. Medical history included vertigo seven years ago and she had taken a Meclizine for it. The patient wore hearing aids On the day of first COVID-19 Vaccine she was perfectly healthy. She was very alert for a 90-year-old. The patient had received influenza vaccine on unknown date. On 11Feb2021 the patient experienced Vertigo and throwing up. The patient was hospitalized for the events from 11Feb2021 to 13Feb2021. The patient received Meclizine, but it wasn't helping. The patient was admitted for 3 days until she felt well enough. The hospital took a blood test with unknown result. The patient did a little bit of physical therapy and she was given mostly IV fluids because she was throwing up. The outcome of the events was unknown.

patient experienced ankle, knee, and wrist stiffness/pain and dizziness beginning within 1 day following vaccination; symptoms continued into the 3rd day after vaccination (the day patient called and reported)

dizzy; This is a spontaneous report from a contactable consumer reporting on behalf of her mother. A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL 8982), via an unspecified route of administration on 16Jan2021 at 16:30 (at the age of 90-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included Bronchiectasis, osteoporosis, anemia, Pre- Diabetes, Sjogren's, sleep apnea, GERD and SIBO. The patient has known allergies but these were not specified. The patient was not pregnant at the time of vaccination. The patient was vaccinated at a nursing home/senior living facility. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included zolpidem (MANUFACTURER UNKNOWN), magnesium (MANUFACTURER UNKNOWN), pyridoxine hydrochloride (B6 MANUFACTURER UNKNOWN), zinc (MANUFACTURER UNKNOWN), biotin (BIOTIN MANUFACTURER UNKNOWN), colecalciferol (D3 MANUFACTURER UNKNOWN) and cyanocobalamin (B12 MANUFACTURER UNKNOWN), all from unknown dates and for unspecified indications. On 17Jan2021 at 12:00 (also referred to as "two days after the vaccine"), and for five days, the patient was very dizzy. She says it wasn't vertigo. It was not spinning. just dizzy like she thought she was going to faint and fall on the floor. She tried to be "sure footed" when she walked and did not walk much other than in her Condo. The patient did not receive any treatment for the event. The clinical outcomes of the event dizziness was reported as recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

The evening of the administration hands started to tingle, lasted about half hour. The next morning felt fine at noon the second day started with violent shaking chills which lasted one hour, at that time it slowly started to stop but felt icy cold with sweating. Took 2 tablets of advil 200mg at the beginning of shaking. After shaking slowed down could not talk, stand or hold up hands; she was drooling barely could swallow. She just wanted to lay down and sleep. This lasted about 30-45 minutes. Hands turned BLUE to her wrists lasting 15 minutes. Resolved without intervention. Very tired that evening. Slept for 12 hours. Back to normal the next day.

Site: Pain at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: Coroners Office contacted Pharmacy on 3/21/21 to report a patient who had recieved a dose of the covid vaccine on 3/18/21 and was founded deceased on 3/20/2021

3 days after vaccination, patient fell and needed to be taken to ER for potential leg and/or head injury

experienced dizziness for 4 days following the shot then on day 7 following the vaccine, she developed an eye hemorrhage.

feel very weak; unstable walking; I am wondering; feel very weak, unstable walking and I don't know if it may be in my stomach too, I am feeling upset feeling in my stomach; This is a spontaneous report from a contactable consumer (Patient herself). A 90-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Not reported, Expiration date: 31May2021) via unspecified route of administration on 02Feb2021 at SINGLE DOSE for COVID-19 Immunization. The patients medical history was not reported. Concomitant medication included vitamins. The patient stated I am wondering; feel very weak, unstable walking and I don't know if it may be in my stomach too, I am feeling upset feeling in my stomach. The patient did not receive treatment medication. The outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.

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

Not been able to walk; Motor skills diminished; Speech has also been deterred; She is in bed right now, can't move; She is not responding; This is a spontaneous report from a contactable consumer. A 90-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown, expiration date unknown), via an unspecified route of administration on 30Mar2021 on right arm at a single dose for COVID-19 immunisation. Medical history included Blood pressure high, heart condition, diverticulitis, ongoing constipation and ongoing pain. Concomitant medications included clonidine (tablet, 0.1 mg) at 0.1 mg, once a day, duloxetine (capsule, 20 mg), orally at 20 mg, two times a day (one in morning and one in evening), simvastatin (tablet, 10 mg), at 10 mg, once a day (at bed time once a day), doxazosin (tablet, 4 mg) at 4 mg, two times a day, carvedilol (tablet) at 3.125 mg, twice a day (takes half a tablet twice a day one in the morning one in the evening half, they cut in half), lisinopril (tablet, 5 mg) at 5 mg, once a day, paracetamol (TYLENOL, tablet, 500 mg) at 500 mg, as needed (takes one in the morning and one in the evening or as needed if she is in pain) for pain, acetylsalicylic acid (ASPIRIN, tablet, 81 mg) at 81 mg, once a day, iron (tablet, 65 mg) at 65 mg, two times a day, bisacodyl (tablet, 5 mg) as needed for the constipation and geri-Kot 8.6 mg, tablet as needed for the constipation. Reporter stated, "he just wanted to call on behalf of his mom. She took the vaccination on the 30Mar2021 and her side effects has been, she has not been able to walk and so right after the shot we brought her home and immediately after that her motor skills diminished. So, She was in bed and can't move on an unspecified date in 2021. He had called the doctor and let them know what her prognosis is. Her speech has also been deterred on an unspecified date in 2021. She was due for the second shot, he was scared for her to get the second shot because he doesn't know if she is going to recuperate from the first shot, she is due 27Apr2021. Needed to report this information on what her prognosis is, was very scared and patient was not responding on an unspecified date in 2021 and reported that don't know what to do. It reported that, her primary doctor gives her lab and her kidney doctor takes lab. The patient had not recovered from the events not been able to walk and she is in bed right now, can't move and the outcome of the other events was unknown. Information on the lot/batch number has been requested.

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

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

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

nausea; dizziness; blurred vision; stomach is starting to hurt; I am unable to function in a normal capacity/could not get out of the bed.; sick; Im not alert long enough; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 09Jul2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) received from a Pfizer colleague. A 90-yerar-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 27Feb2021 (lot number: EN6198) at dose 1, single, then second dose on 20Mar2021 (lot number: EP1534, batch number: EP7534) at dose 2, single; both via an unspecified route of administration at the age of 90-years-old for COVID-19 immunisation. Medical history included glaucoma and brain tumor. The patient has no previous vaccinations within 4 weeks. Concomitant medications were reported as none. Historical vaccine included flu vaccine back when the patient was a teenager and experienced allergic reaction that broke out with a rash, shaking, and itching. On 27Feb2021, after the vaccination of the Pfizer COVID vaccine, the patient experienced bad reactions daily. The symptoms include nausea, dizziness, and blurred vision. The patient has been unable to work because of it. These events caused the patient to seek medical attention from her primary care provider and vision care provider. The patient has a history of glaucoma, making it very difficult. The patient had to get a CT scan on an unspecified date because her doctor thought that a tumor may have come back to her brain, but the result of the CT scan was clear, and the tumor was not back. As a result, the doctor prescribed medication for dizziness (taken 3 times per day) and nausea (taken as needed). The patient stated that she was unable to function in a normal capacity from an unspecified date in 2021 without the daily treatment medications and still the treatment medications were not always effective in reducing the symptoms. The patient stated that the nausea was getting worse every day. At 5am, it woke her up and she took the pill and lasted a couple of hours but it came back and took another pill. The patient was taking ondansetron 4 mg orodispersible tablet taken under the tongue. On an unspecified date in 2021, the patient's stomach was starting to hurt and takes another pill for this. The patient reported that her ophthalmologist did the examination on an unspecified date in 2021 and stated that this examination had no difference from the previous examination on an unspecified date. The patient stated that her daughter also had the vaccine and had a sore arm for two or three days. The patient also reported that she could not get out of the bed. She had a blurred vision and cannot read without a magnifying glass. It was terrible and the patient had never been this way. The patient takes a medication for the blurred vision and it doesn't last. The patient cannot function, and her doctor already knows this. The patient will see her doctor again on the 26th. On an unspecified date in 2021, the patient was sick all day because of the nausea. The patient had 4 doses of medication and it did not last anytime. On an unspecified date in 2021, the patient was not alert long enough. Yesterday, the patient's nausea woke her up at 5am. She took a pill under the tongue, and before 8am, nausea attacked her again in a couple of hours and all day long. All day yesterday, the patient was nauseated like a morning sickness when pregnant. The nausea quieted down after the patient took a tea but started again after lunch. The patient stayed sitting all day. The patient reported that she experienced the same events after the second dose. The events nausea, dizziness, and blurred vision resulted to physician office visit. Outcome of the events alertness decreased, nausea, dizziness, and blurred vision was not recovered, and for other events was unknown.

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

Less than 30 minutes after receiving vaccine patient reported some itchiness on right arm as well as some light-headedness and an "odd" feeling on her right side only. Blood pressure was 126/68mmHg. Recommended water and some food if possible. Patient's symptoms resolved on their own after patient had lunch - did not report any new or worsening symptoms roughly an hour after vaccine administered. No medications were given to patient to treat symptoms.

01/11/2021- Found lying on bed in apartment, incontinent, lethargic, unable to respond to questions, unable to do hand grasps. sent to hospital. 01/14/2021- remains in hospital- confusion and disorientation continues, poor verbal skills, limited ability to feed self, out of bed to sit in chair. uncertain of return to facility status.

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

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

Patient complained of dizziness during the 15 min observation period post-vaccination. Patient requested water which was provided. Patient complained she had difficulty swallowing and shortness of breath. Patient was sent to the onsite Emergency Department. Patient was place in bed in supine position. Symptoms resolved. No further treatment was provided.

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

On 1/28/2021, 3 days after her injection my mom started feeling unwell. She felt dizzy, drowsy and had no energy (fatigued). This went on for 4 days (until 1/31/2021). She called a nurse at her facility morning of 1/31/2021, who told her it was most likely a side effect from the vaccine. My mom did not feel reassured and called the front desk at her facility. Eventually 911 was called, the paramedics came afternoon of 1/31/2021 and they told her her blood pressure was not quite right, and if she wanted to go to the hospital. She said no. She was less upset though. She still didn't feel "normal" until 2/2/2021. She is prone to panic and PTSD if things don't feel right.

This is a spontaneous report from a contactable Consumer. A 91-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3249, Expiry Date 31May2021 ), at single dose into the left arm on 20Jan2021 at 11:30 am for COVID-19 immunization. Medical history included problem with gallbladder in the last 4 months. Concomitant drugs were none. The patient had never problem with flu and shingles shot. On 20Jan2021, the day of vaccination the patient felt fine and told everyone it was a breeze. On 21Jan2021 morning she was getting ready to go to the store at 1130am, it was about 24 hours after getting the shot, and she felt dizzy, achy, her eyes ached and were weak, she felt feverish but had no fever and was a bit nauseated. The patient also reported loss appetite the same day. On 22Jan2021 around 11am she felt a little better. She checked her temperature and blood pressure normal. She has had a little nausea in the evening and was dizzy. On 23Jan2021 she felt a little weak but felt better and her appetite was better. At the time of reporting the outcome of the events was unknown.

dizziness; diarrhea; generalized aches; This is a spontaneous report from a contactable consumer A 91-years-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 dose 1 at SINGLE DOSE for covid-19 immunisation. Facility type vaccine: Nursing Home. Medical history included cardiac assistance device user, hyperthyroidism, hypertension, blood cholesterol increased, macular degeneration, glaucoma, osteoporosis. Concomitant medication included calcium (CALCIUM), flecainide (FLECAINIDE), chondroitin sulfate, glucosamine sulfate (OSTEOFLEX [CHONDROITIN SULFATE;GLUCOSAMINE SULFATE]), vitamin d (VITAMIN D) , meclizine [meclozine] (MECLIZINE [MECLOZINE]). The patient experienced dizziness on 16Jan2021 20:00 with outcome of not recovered, diarrhea on 16Jan2021 20:00 with outcome of not recovered, generalized aches on 16Jan2021 20:00 with outcome of not recovered. The action taken was not applicable. Information on the lot/batch number has been requested.

On Feb 3 woke up very dizzy, lightheaded, arm pain. Feb 9th developed rash on both arms from elbows to hands, extremely itchy and also had a large blister develop on left arm.

Patient had declining health for the past 6 months, dementia and unable to walk. Patient had decreased appetite starting 1/1/21. After 1st vaccine shot patient appetite decreased further. After 2nd vaccine shot patient fatigue increased to the point where she could not get out of bed and had minimal appetite. Patient passed away 10 days after receiving 2nd shot on 2/22/21. Patient did not go to ED and was not hospitalized.

stiffness in neck and shoulder to the point that I almost could not raise my head, persisting overnight and into a second day

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

Morning of 2/3/21 Pt woke up feeling lightheaded and dizzy. On 2/8/21 she developed a rash on both arms from the elbows down to the wrists which was extremely itchy and warm. There was also a large blister on her lower left arm. Her face was also red, very tight and warm! Took her to her general physician on 2/9/21 he had no idea of what was happening. Took her to dermatologist on 2/11/21 and she immediately sent her for an extensive bloodwork workup. The results of the bloodwork is bullous pemphigoid.

Dizzy; not feeling well; Constant noise started in my head, sometimes on right, sometimes on left, most of the time my entire head/a "shush"ing sound, like steam evaporating from a teakettle letting out steam; This is a spontaneous report from a contactable consumer, the patient. A 91-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown),via an unspecified route of administration in the left arm on 27Jan2021 at 15:00 (at the age of 91-years-old) as a single dose, for COVID-19 immunisation. The patient had no known medical history or allergies.The vaccine was administered at a Nursing Home/ Facility. Concomitant medications included macrogol 3350 (MIRALAX) and losartan potassium (LOSARTAN POTASSIUM) 25 mg. Historical Vaccine includes BNT162B2, Dose 1; Administration date: 06Jan2021 at 03:00, Lot Number Not Provided, in the left arm. On 31Jan2021 at 12:00 the patient experienced dizziness, malaise and tinnitus. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The clinical course was reported as follows. About 4 days after Second shot, on '31JAN2021 at 12:00' patient started to get dizzy and not feeling well. Constant noise started in my head, sometimes on right, sometimes on left, most of the time my entire head. It is like a "shush"ing sound, like steam evaporating from a teakettle letting out steam. This has been for 2 weeks. The patient went to the Emergency Room and/or Doctors Office and was checked, vital signs normal, had scan of head and stomach, EKG and bloodwork. No treatment was given for the events.The noise has never subsided in the past 3 weeks. . The patient underwent lab tests and procedures which included blood test: unknown results on and unknown date, electrocardiogram: unknown results on an unknown date, Scan of head and stomach unknown results on an unknown date and vital signs measurement: normal on an unknown date. The clinical outcome of the event dizzy, malaise and tinnitus was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

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

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

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

blister on her arm/blisters on both arms, from elbows to hands, upper, forearm, face and neck; rash on both arms; It was a very itchy rash, kind of red and blotchy on both arms, forearms to fingers; It was a very itchy rash, kind of red and blotchy on both arms, forearms to fingers; It was a very itchy rash, kind of red and blotchy on both arms, forearms to fingers; arms were so inflamed and itchy; arms were so inflamed and itchy; felt light headed/Dizziness; This is a spontaneous report from a contactable consumer (patient's daughter). A 91-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration Date: unknown, NDC number: unknown), via an unspecified route of administration, administered in Arm Left on 01Feb2021 15:30 (at the age of 91-year-old) as single dose To protect from Covid virus. Patient's Medical History (including any illness at time of vaccination; Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity) was none. Illness/AE: None. Pertinent Details (include surgical procedures and dates): N/A. Family Medical History Relevant to AE(s): None. There were no concomitant medications. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional vaccines administered on same date of the Pfizer Suspect was none. On an unspecified date in Feb2021, the patient experienced Dizziness, Lightheadedness, broke out in a rash; very itchy rash, blisters on both arms, from elbows to hands, upper forearm, face and neck, red and blotchy on both arms, forearms to fingers, arms were so inflamed and itchy. The patient received the first dose of COVID-19 vaccine and developed a rash on both arms 6 days post vaccination. The reporter had noticed on day 8 (09Feb2021) a huge blister on her arm. She also felt light headed. The reporter thinks these side effects were related to the vaccine and wanted to know if they are reported with the vaccine. She also wanted to know whether the patient could get the second dose of the vaccine. It was reported that seems to be having a reaction to the first Pfizer Covid-19 shot. A couple days later, she had dizziness and lightheadedness and then days after, Day 6 (07Feb2021), that broke out in a rash. Yesterday, day 8 (09Feb2021), she had blisters on the arm and there is no other reason for her to have them, it wasn't like she did anything. Blisters are on both arms from elbows to hands. Had a little bit on the face and neck, none on her trunk, just on the upper forearm and hands. Is there anyone who has reported this reaction. Still had the rash and blisters, they had not changed. It was a very itchy rash, kind of red and blotchy on both arms, forearms to fingers. Had nothing where the injection was, it was just from the elbow down. Did go to the doctor yesterday (09Feb2021), for the rash and blisters and they had no idea what it was. Her arms were so inflamed and itchy they gave Methylprednisolone tablets to help. The patient did not visit Emergency Room, but visited Physician Office for dizziness, lightheadedness, rash, very itchy rash, blisters on both arms, from elbows to hands, upper, forearm, face and neck, red and blotchy on both arms, forearms to fingers, arms were so inflamed and itchy. No Investigation Assessment. No Relevant Tests. Outcome of the event felt lightheaded/dizziness was recovering and all other events were not recovered. Information on the lot/ batch number has been requested.

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

Unexplained hoarseness at 7:00 am 02/06/2021 and cough at 0:700 pm on 02/06/2021. Fall (first time ever), followed vomiting, and choking at 2:00 pm 02/07/2021. Ambulance called recorded vitals 97.5 Temp 102/70 BP, 98 HR at 2:51 pm at home and 146/90 BP 102 HR at 3:09 pm enroute to hospital; pt pointed to hip pain and answered questions in native language Polish (although pt spoke English). Pt delivered alert and kicking blankets off legs inside emergency room. Emergency room staff failed to communicate with pt. Pt was discovered unresponsive 20 minutes later when staff arrived to take admission vitals. Pt passed 02/07/2021 in ER. No causeof death given by ER doctor to family.

she feels like she is another world and has to lay down frequently; she feels like she is another world and has to lay down frequently; She has been experiencing intermittent dizziness; she feels like everything is a blur; injection arm is "black and blue."; This is a spontaneous report from a contactable consumer (patient) reported that a 91-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on 28Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She has been experiencing intermittent dizziness, she feels like everything is a blur, she feels like she is another world and has to lay down frequently, vaccination site bruising on an unspecified date. Her injection arm is "black and blue." She wants to know if this is normal after the vaccine, she states she is going to an eye doctor appointment tomorrow 20Mar2021. No PQC involved. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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

passed away; cough; This is a spontaneous report from a contactable consumer, the patient's daughter. A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 13Jan2021 at 11:00 (at the age of 92-years-old) as a single dose for COVID-19 immunization. Ongoing medical history included nursing home resident, admitted to hospice on 13Jan2021 (prior to vaccination), and oxygen supplementation (due to low oxygen levels) from a few days prior to the vaccine (Jan2021). Other relevant medical history included congestive heart failure from Dec2020 and sulfa allergy. Prior to the vaccination, the patient was tested numerous times (as reported) for COVID-19 and was negative. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. A few days before the vaccination, her oxygen level had gone down, and she had been placed on oxygen. Prior to receiving the vaccine, the patient was reported as being 'fine'. On 13Jan2021, the patient received the vaccine at 11:00. The patient coughed maybe 5 or 6 times and then dropped her head. Resuscitation was not performed as patient had a do not resuscitate (DNR) order. The patient passed away on 13Jan2021 at 13:05. The cause of death was not reported. An autopsy was not performed. The clinical outcome of the cough was unknown at the time of death. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away

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

Resident had slight/slow decline in health prior to vaccine but continued to be able to walk around with walker at community. The day of the vaccine she had a fever. 2 days after vaccine resident did not get out of bed all day and refused to eat. She had small amounts of orange juice as her blood sugar level was low due to not eating. Resident was diagnosed with a UTI and began an oral antibiotic. 3 days after and on day 5 after vaccine resident began feeling weak and had a fall on each day. The following day again resident spent the day in bed. The next day she was quite restless, was on the edge of her bed attempting to self transfer often throughout the day. Resident continued to be restless on the 10th of Feb, had further decline on the 11th of Feb. Resident passed away early the AM of Feb. 12th.

Starting Sat. Jan. 30 I was dizzy almost every morning when I first sat up on the edge of my bed. Dizziness stronger sometimes than other. Dizziness lasted 10 to 20 seconds. Sometimes when I lie down at night I have this dizziness. I called specialist office and a man called me back and told me to check blood pressure but I couldn't get blood pressure cuff to work.

Pfizer-BioNTech COVID-19 Vaccine EUA Received dose #1 in drive thru vaccine clinic and reports shortness of breath, lightheadedness, left hand tingling post vaccination on right arm. Taken to ED for further assessment. Pt has COPD but patient feels these symptoms are different. After some time, daughter feels patient is back to baseline. ED visit on 2/12/21 (12:03p - 15:02p)

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

15 minutes after receiving vaccine, she noticed legs becoming more numb than usual and difficult to move them. Had to have additional assistance ambulating, getting out of chair, getting into bed unable to raise legs into bed, assistance in the bathroom, had to hold onto her to stabilize.. This lasted for 30 hours with gradual resolution of symptoms. she remains with her usual neuropathy at this time.

RECEIVED 1ST DOSE OF PFIZER COVID VACCINE ON 02/21/21. ON 02/27/21 WENT TO ICC F OR RT HIP PAIN AND KNEE PAIN AFTER FALL ON 02/27/21 AND HAD XRAYS. ON 02/27/21 WENT TO ER AND HAD CT OF RT HIP WO CONTRAST DONE . DIAGNOSED WITH HIP PAIN (ACUTE,RIGHT) AND FALL (INITIAL ENCOUNTER). INSTRUCTED TO FOLLOW UP WITH PCP.

The patient began experiencing headache the evening of receiving vaccine (02/25/2021). She reports awakening the following morning with left upper and lower extremity pain and weakness and was unable to ambulate. She also reported some slurring of speech. These symptoms lasted for a few hours and then resolved. Headache, left-sided pain and weakness and slurring of speech have resolved.

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

Approximately 24 hours after vaccine administration, patient began to ache all over, feel dizzy, became light-headed and fell off the toilet. Had emesis. Subsequently struck her head on the wall and suffered a cervical fracture and required transfer to a higher level of care.

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

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

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

13 days post vaccination patient wakes up with a slight itch in here ears. By 4pm she reports a sudden hearing loss in her right ear. On day 14 she proceeds to get very weak with vertigo, nausea, and anorexia. No temp or other signs of illness. On day 15 we take her to ER and work up was negative. On day 16 we take her to ENT no explanation of the sudden hearing loss but is told she is totally deaf in the right ear and needs a hearing aid in the left. She did not have this prior to the vaccination and it was a sudden onset.

Failing health since vaccine; she does not want to eat; She slept probably five hours during the day; She got up and she does not want to eat, she took a nap, she changed chairs and she took a nap; Her health has declined each day; She has more fatigue every day; In constant pain; Lost 20 LBS.; became weak and lightheaded; became weak and lightheaded; her immune system began to shut down; The initial safety information received was reporting only non-serious adverse drug reaction, Upon receipt of follow-up information on 26Mar2021, this case now contains serious adverse reactions. Information processed together. This is a spontaneous report from a contactable consumer. A 92-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in Arm on 04Feb2021 at 12:30 (Batch/Lot Number: EN5318) as single dose for COVID-19 immunization. Medical history included ongoing diabetes, arthritis and thyroid, all three for 10 plus years; and bladder. Concomitant medication included ongoing methotrexate and meloxicam taken for arthritis; metformin taken for diabetes; mirabegron taken for bladder; and levothyroxine taken for thyroid, all from an unspecified start date and ongoing. The patient received the vaccine on 04Feb2021 (reported as last Thursday afternoon) and everyday since then her health has declined each day. She has more fatigue every day and lightheaded. Her immune system began to shut down (several blood draws taken). She just wanted little afternoon nap. On Saturday, she wanted to do very little 'aero' (word not clear), very little just the minimum. She get up, she had a little breakfast, and as I live near a little pond, she watched the water and birds. And then yesterday, she slept probably five hours during the day and today that is all she has done, she got up and she does not want to eat, she took a nap, she changed chairs and she took a nap. She is now in her bedroom and taking another nap and this is not my mother. The patient was still alive but in failing health since the vaccine. The patient is now bedridden, lost 20 pounds (lbs) and was in constant pain. The patient was fine, walking and even dancing prior to vaccine. The outcome of the events "Her health has declined each day" was not recovered while unknown for the other events. The patient died from vaccine on 15Mar2021. The autopsy was not done. Follow-Up (02Apr2021): Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Failing health since vaccine

My Mom went from being able to walk fine on her own to suddenly being confined to a wheelchair because she could not walk after the 2nd vaccine. She was lethargic, weak, sleepy & in excruciating nerve pain throughout her body. Her doctors office said to let her get plenty of rest, fluids, & to take Tylenol for pain. She had previously had only mild cognitive impairment, which seems to have become accelerated & she is much more confused. Because she was sleeping & not eating & drinking enough, she then became dehydrated. She was then admitted to the Emergency Room Hospital

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

Client sat down shortly after receiving covid 19 vaccination. Slipped off of chair. A/O x3 with no loss of consciousness. Denies any injury. BP100/78 81 hr and 98% oximeter. Assisted to cot until the dizziness subsided. Encouraged to eat granola bar and water and retook vs prior to discharging after 30 minutes. 124/72 bp-97% and 61 hr.

She began with an earache and dizziness. Pain got so severe that she could no longer take it. Went to the doctor which she was put on pain medications. Went to ER on 1/6 and on 1/7 went to her PCP. Still in severe pain.

felling dizziness; nausea; not feeling strong; This is a spontaneous report from a contactable consumer (patient). A 93-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at left arm on unspecified date in Dec2020 at SINGLE DOSE for COVID-19 immunization and lubiprostone (AMITIZA) , via an unspecified route of administration from Dec2020 to an unspecified date at 1 DF, 2x/day as laxative..Medical history included:TIA started in Dec2020, bowel problem, fell (she fell about 3 weeks before she got the Pfizer COVID-19 shot) and some memory loss ( not serious).She wanted to know if she should receive her second dose of the COVID-19 vaccine if she was presenting the following side effects: felling dizziness, nausea and not feeling strong. She was currently taking Amitiza as a laxative. She believed these side effects were not related to the administration of the first dose of the vaccine and were rather common conditions for her age , she also stated that she did not have any "negative feelings" with the first shot of the vaccine. Consumer said she had an appointment today for her second shot of the Pfizer COVID-19 vaccine and got a letter yesterday that said she could get it at 03:00PM today at the center where she got the first vaccination. She said that they gave the shot in her left arm for her first vaccination. She said it was very common at this age that she very often didn't feel well, and she was on a new laxative that might be causing some upset. She said she had no fever, she was not nauseated, she had no headache, there was nothing wrong. However the outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events dizziness, nausea and asthenia cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. Further details about the patient's medical history, concomitant conditions and the events would be helpful. The contributory role of the concomitant laxative also cannot be excluded. This case will be reassessed once 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.

Systemic: Generalized Body Aches -Medium, Systemic: Nausea-Medium, Systemic: Light-headedness and difficulty breathing-Medium

ADVERSE REACTION REPORTED AS TEMPERATURE OF 100.0, CONFUSION, AND VERTIGO. PATIENT WAS TAKEN TO HOSPITAL, UNAWARE OF CURRENT STATUS, TREATMENTS, OR OUTCOME.

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

On 01/19/2021 patient was observed to have a slight right facial droop and slight slurred speech, hand grips were equal, pupils equal and reactive, she had difficulty moving her right leg. 911 activated due to possible CVA, admitted to the hospital , a MRI was done to rule out a stroke. Readmitted 1/20/21 with the diagnosis of probable Bell's Palsey. The patient is stable medically at this time. Facial droop remains at this time, she is able to swallow without difficulty.

Pt. reported feeling "different", dizzy, notified. BP 200/110, HR 78, SO2 98% Called PCP and pt was taken to ER.

1st dose vaccine 1/30/2021; fall of unknown etiology at home on 2/1/21; went to urgent care 2/1/21 for back pain, sent to ED same day for eval; admitted to hospital on 2/1/21 from ED for T12 compression fracture.

Patient developed unsteadiness two days after the vaccine, and became progressively delirious, then obtunded and was placed on comfort care thereafter.

In the 2-3 days before the date specified, patient was very tired and went to bed early. On the date specified she couldn't function and didn't get out of bed. She was so weak she didn't call back or answer the phone when the call dropped. She was confused and said she didn't feel right and didn't know what was wrong. No pain reported.

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

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

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

Prolonged tiredness; increased weakness; dragging right foot when walks; little more trouble swallowing pills than before; little more trouble swallowing pills than before; This is a spontaneous report from a contactable consumer (the patient). A 93-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), via an unspecified route of administration in the right arm on 26Jan2021 09:15 (at the age of 93-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: aortic stenosis, COPD (chronic obstructive pulmonary disease), blood pressure medications, and trouble swallowing pills. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Jan2021, the patient experienced prolonged tiredness, increased weakness, dragging right foot when walks, little more trouble swallowing pills than before. No treatment was received for the events. The clinical outcome of the event was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Patient received vaccine and approximately 30 minutes afterwards began experiencing tongue swelling, bilateral hip, knee, leg and shoulder pain, and dizziness.

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

Dizzy; This is a spontaneous report from a contactable consumer. A 93-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201, expiration date: unknown), via an unspecified route of administration in right arm on 10Feb2021 at 02:40, second dose via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Feb2021, the patient experienced dizzy. The dizziness would stay as long as she stands up, but if she sat down, she was fine. They did not think much of it and did not really but anything together. She was calling to try and get some help/advice on what to do. They have tried motion sickness pills and called the doctor and has seen the doctor 2-3 times. She cannot think of anything else to do in order to help. She was hoping we would be able to provide some advice and say something that they should do in order to help. The patient's blood was draw, but did not find anything else going on. The outcome of the event was not recovered.

PT presented to ED after a fall admitted 4/8/21. SARS-COVID-19 resulted positive 04/09/21 00:42. Patient surpassed the two week post vaccination. Pfizer dose 1 Lot EL0140 received 1/15/21, dose 2 received 2/22/21. PT documented to be asymptomatic

1/21/2021 First dose: 1/23/2021 adverse reaction: Headache, Chills, Pain in Arm, Feeling like a fever all night long but no fever, no sleep aches/pains, burning up, hot feeling, very tired, shuffling, 2/18/2021 Second Dose: 3/01/21 adverse reaction: As experienced and seen by daughter: Extreme fatigue, shuffling, some confusion and memory affected ( did not know how to use credit card- BEFORE shot never an issue with her shopping or paying her bills on her own) , difficulty with making a decision, slept more, tired when walking (used to walk an hour - could only do 20 min if that) NO dementia associated with my mother. Was able to function fully

diarrhea; lightheadedness; dizziness; This is a spontaneous report from a contactable consumer(patient). A 93-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in Arm Left on 04Feb2021 at 09:45 (at the age of 93 years old) as first dose, single for covid-19 immunisation at School Health Clinic. Medical history included hypertension, hyperthyroidism, osteoarthritis from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Allergy to paper and Dairy products from an unknown date and unknown if ongoing. Concomitant medications included amlodipine (AMLODIPINE), telmisartan (MICARDIS) and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Patient was not received any other vaccine prior four weeks of vaccination. Patient received Amlodipine -10mg; Micardis 120mg; Synthroid 50m within two weeks of vaccination. Pfizer vaccine taken on Thursday 04Feb2021 at 09:45 and by Friday on 05Feb2021 at 14:15 afternoon had dizziness. Sunday on 07Feb2021 afternoon experienced lightheaded ness and on Monday 08Feb21 afternoon experienced dizziness and diarrhoea. Therapeutic measures were taken as a result of the events with Peptide Bismal. The outcome of the event was reported as not recovered. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

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

had a fall; This is a spontaneous report from a contactable nurse who reported for her grandmother. A 94-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 29Dec2020, at the age of 94 years, at a single dose for COVID-19 immunization. Medical history included patient was admitted for a broken hip on 19Nov2020, and was then transferred to another institution on 24Nov2020; and patient does have a diagnosis of dementia. There were no prior vaccinations within 4 weeks. There were no concomitant medications. The reporter is a Pfizer Employee calling in regards to the COVID-19 vaccine. She was calling in regards to her grandmother who is in an inpatient rehabilitation facility. On the 16Jan2021, the patient had a fall in the rehab facility and was admitted into the hospital as a part of the facility's fall protocol. The patient was on Lovenox. The patient was admitted into the hospital on 16Jan2021 and was evaluated and discharged on 18Jan2021. At that point on 18Jan2021, Lovenox was stopped. The event was reported as serious per hospitalization. The facility has also been testing residents weekly. The patient was tested negative in the hospital when she had the broken hip and also negative when she went into the hospital for the call. The outcome of the event was recovered on 18Jan2021. No follow-up attempts are possible; information on lot/batch cannot be obtained.; Sender's Comments: The reported fall likely represents an intercurrent medical condition in this 94-year-old female, and is considered unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

32 hours post vaccine 8 hours of severe body ache, unsteady walking, sleeplessness 2 aspirin taken 4 hours apart symptoms reduced significantly at 8 hour mark

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

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

started with dizziness, nausea, abd pain on 3/29/2021. treated conservatively. seen in office on 3/31/2021. She started improving the morning of 4/1/2021. Developed Left Bells Palsy on the afternoon of 4/1/2021. Seen in office on 4/2/2021

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

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

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

Chills but no fever; Headaches for one and a half weeks; Dizziness; This is a spontaneous report from a contactable consumer reported for herself. A 94-year-old female consumer reported that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), on 06Feb2021 12:00 AM (at the age of 94-years-old) at single dose for COVID-19 immunization. medical history included Allergies to Penicillin. Concomitant drugs were unknown. On 08Feb2021 the patient had chills but no fever. Headaches for one and a half weeks and Dizziness. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained

disoriented a little; Has been terribly sick, almost continually; Hurts mostly in back and legs and has difficulty walking; Hurts mostly in back and legs and has difficulty walking; Hurts mostly in back and legs and has difficulty walking; eye sight went; hearing was not good to begin with but now her hearing is much worse; hearing was not good to begin with but now her hearing is much worse; Of course, is kind of out of it and doesn't know exactly what to say even though knows what wants to say; has no energy; terribly congested; has cough that turns into a violent sneeze, a couple sneezes; has cough that turns into a violent sneeze, a couple sneezes; has a runny nose and all the symptoms of a bad cold but the caller doesn't think she really has a cold.; has a runny nose and all the symptoms of a bad cold but the caller doesn't think she really has a cold.; hurts so bad; This is a spontaneous report from a contactable consumer (patient). A 94-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 (Lot Number: EW0151) as dose 2, single at the age of 94-years-old for covid-19 immunization. The patient medical history included: ongoing hearing was not good. There were no concomitant medications. The patient received the first dose of bnt162b2 (Lot Number: PN6208) on 10Mar2021 in left upper arm for covid-19 immunization. The patient will be 95 years old in just a few more days. The patient received the second dose on 08Apr2021. The patient was fine until about Dec2020. The patient had been terribly, terribly sick almost continually. The patient took half a pill Fenofibrate a day. The patient is going to be 95 years old very soon and the patient had always been very, very active. The patient was never sick. All of a sudden, the patient had shut down to almost nothing. The patient had no energy. The patient hurt so bad, whole body had been so sick and can do very little and had to rest. The patient hurts mostly in her back and her legs and had difficulty walking. This began a month ago, everything began a month ago. The patient's whole system is out of whack. The patient will have all kinds of time to get to the bottom of this. The patient was just at the primary care physician's office yesterday, 15Jul2021 and the physician was at the whit end. The patient was terribly congested, had cough that turned into a violent sneeze, a couple sneezes. The patient had a runny nose and all the symptoms of a bad cold but the patient didn't think she really had a cold. The patient clarified congestion and sneezing began a month ago. Patient stated everything occurring began a month ago. The patient's eye sight and hearing went at the same time, really bad. This began about a month ago. Everything all of a sudden happened over night. The patient felt great and was doing yard work and very, very active almost 95 year old. The patient is down to zero now. The patient stated her eye sight is worsening. The patient stated her hearing was not good to begin with but now her hearing is much worse. Of course the patient is kind of out of it and didn't know exactly what to say even though the patient knew what she wants to say. The patient is disoriented a little. The patient stated all of this began a month ago. The patient stated all of these symptoms did not come gradually, it was like overnight. The patient got up and everything was there at once, not one think after another. Everything was there when the patient got up, the patient was a different person. Outcome of the events eye sight went and hearing went was not recovered, of other events was unknown.

REPORTED DIZZINESS AND WEAKNESS IN LEGS AFTER RECEIVING VACCINE. HAD A PREVIOUS REACTION TO FLU VACCINE. WAS MONITORED FOR 30 MINUTES.

After receiving the COVID-19 vaccine, the client verbalized lightheadedness. Client was evaluated by onsite Fire Rescue. Client symptoms resolved within 15 mins. Client was released to go home at 2:34 pm by Fire Rescue.

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

DEVELOPED FATIGUE, WEAKNESS. NORMALLY AMBULATES WITH A WALKER, BUT REQUIRED A 2-ASSIST WITH TRANSFER AND USING A WHEEL CHAIR. WAITING FOR GUIDANCE FROM PCP.

very weak; couldn't stand or walk; couldn't stand or walk; fever; could barely speak; lethargic; fell into a deep sleep; This is a spontaneous report from a contactable consumer (patient). A 95-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9261) via an unspecified route of administration on the left arm on 19Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included AFIB, chronic anemia, hip surgery in Aug2020 (recovering) and diagnosed with COVID-19 (prior to vaccination). Concomitant medication included levothyroxine sodium (L-THYROXINE), omeprazole (PRILOSEC), calcium carbonate, magnesium carbonate, magnesium trisilicate (TUMS); sodium chloride; ferrous sulfate; folic acid; vitamin D3; guaifenesin (MUCINEX) and clarithromycin (CLARITINE) reported as 'Claratinde'. Approximately 22 hours after injection, on 20Jan2021 03:30 PM patient became very weak, couldn't stand or walk, had a fever, could barely speak, lethargic and fell into a deep sleep. No treatment was received for the events. Events were reported as non-serious. Patient was not pregnant. The facility where the vaccine was administered was in a clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was unknown.

Dizziness and weakness resulting in a fall the evening of the vaccination. Paramedics were called, but patient was not transported to the hospital. Vital signs were okay. Extreme fatigue and continued dizziness for several days. Increased brain fog and confusion.

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

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

can barely walk; upper respiratory problems; Sinus infection; has not been well/ bad shape/ can't be out of bed for 2 seconds with out having to get back into bed/ wasn't feeling good/ not feeling well; chills; fever as high as 104.5; nasal congestion; upper respiratory difficulty breathing/ can't breathe through her nose; non-productive cough; breathing rapid; Arm pain/ sore arm around the injection site; This is a spontaneous report from a contactable consumer (Caregiver/ Patient's daughter). A 95-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Mar2021 14:00 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021. The patient was reported to have possible side effects that was getting worse. The patient had "chills, fever, nasal congestion, upper respiratory difficulty breathing, non-productive cough." On Monday evening, 29Mar2021, the patient was brought to the hospital but tests showed that "everything looked good" (chest x-ray etc.) Last night, the patient's temperature reached 104 F and was given paracetamol (TYLENOL). The patient mentioned that she was "breathing rapid," and that she "coughs when she takes a breath." Reporter asked if patient can be given an antihistamine; or something to help with the upper respiratory concern (nose blockage, upper respiratory breathing). The patient had not been well. They spent Monday evening and all night and in the morning at the hospital. They did X-rays and lab work and everything else. The doctors couldn't find anything wrong with her and stated that it's got to be the vaccine. She was really in bad shape at this point. She can't be out of bed for 2 seconds without having to get back into bed. She was having a upper respiratory thing going on. She had a fever as high as 104.5 last night. The fever was last night and she got paracetamol (TYLENOL) for that and brought it down. It did respond. The patient stated she can't breathe through her nose and she has upper respiratory problems. The problem was when they went to the hospital, they didn't find signs of infections, all normal across the board. The patient doesn't fake it, she was a feisty elderly lady. She walks up the hill every day. She was independent. Normally, she can walk and walks very well without any assistance. The patient now can barely walk. She can barely walk to the toilet without holding on to anything. She was constantly complaining about chills. Reporter wanted to know what can they do and not do and what should the doctors be looking at. They kind of just threw up their hands as this was side effects of the vaccine, but the patient was alarming on Monday night and even more alarming right now. The patient was in bad shape. She wasn't feeling good on Saturday night, but not too bad on Friday night. Reporter asked her mom how she felt on Friday. Reporter told her mom to put in her hearing aids, that would probably help. Reporter further explained that patient had a sore arm around the injection site and that she might not have been feeling that great. On Saturday, she was not feeling well and started to have a fever, sinus infection and upper respiratory problems. The patient stated that she finally identified it. Reporter confirmed the fever, sinus infection, and upper respiratory problems started on 27Mar2021 towards the late afternoon she was progressively getting worse. Fever, sinus infection, chills, upper respiratory problems all have worsened. The reporter stated that her mother's (patient's) arm pain got better on Sunday and was now gone. On Saturday, her arm hurt from her shoulder to her elbow, it did get worse. However, a the next day it was gone pretty much. Monday in the emergency room, they did labs for her kidney, liver and were looking for infection. They did not find anything came up normal on everything. Today, the reporter thinks patient was worse. She doesn't want to come out of bed at all. She was laying there like a lump, whining and crying which she has never done. She was probably going to take her to the hospital again and they were not going to do anything again. She stated that something got to change, They haven't had that conversation about going to the hospital. She was going to go downhill if this continues, it had gone downhill at this point. Reporter confirmed that patient has recovered completely from the arm pain while outcome of remaining events was not recovered. Information about the lot/batch number has been requested.

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

PT recieved 2nd dose of vaccine Pt stateed she felt lighteheaded and had same reaction to first vaccine Pts vitals were taken and were normal and pt left with no issue

Morning following 2nd vaccination patient was confused and not able to keep herself upright in a char, stand or feed herself . All of which she could do the day before. She was sent to medical center for MRI and they found no evidence of stroke and sent her back. She was then sent to rehab where she continued to weaken and not be able to eat or drink . A week later she is now under Hospice care.

2/6/21 Sent to ER for evaluation of agitation and returned a few hours later on 2/7/21 with no acute findings. 2/7/21 continued with agitation and restlessness and had psychoactive medication changes 2/8/21 Had head CT with no acute findings 2/11/21 MRI of lumbar spine with compression fx T10 2/17/21 UA and KUB done with no acute findings Multiple falls within this time frame with escalating agitation, restlessness, and insomnia. Dx psychosis and started on Seroquel 2/25/21 3/2/21 Patient died

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

broke her hip; She described her mother-in-law as being frail and explained she fell; She described her mother-in-law as being frail and explained she fell; This is a spontaneous report from a contactable consumer (reporting for her mother-in-law) via the Pfizer-sponsored program. A 96-Year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 02Mar2021 (received at 96-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter described her mother-in-law as being frail and explained she fell, broke her hip, and had a hip surgery after getting vaccination. She added that her mother-in-law is now in a rehabilitation center. She asked what the longest interval is allowed for getting the second dose of the vaccine. She also asked if the vaccination series will need to be repeated when the second dose if given past 6 weeks. Therapeutic measures were taken as a result of broke her hip (hip fracture). Outcome of the events was unknown. Information on the lot/batch number has been requested.

Sudden dizziness while standing outdoors; extreme chills; heavy breathing difficulty; Nearly fell over; This is a spontaneous report was received from a contactable consumer (patient). A 96-years-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 27Jan2021 11:30 as single dose for covid-19 immunisation. Medical history included allergies to medications, food, or other products maybe penicillin. Concomitant medications included lovastatin, thyroid patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29Jan2021, at 11:00AM, the patient had experienced sudden dizziness while standing outdoors 48 hours after vaccine injection, extreme chills, and heavy breathing difficulty. Nearly fell over but son caught her. Treatment received for the adverse event are unknown. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up (15-Apr-2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

her mother's body was full blown with leukemia/she wasn't responding/leukemia was back; Second dose: breathing heavy; Second dose: screaming in agony and pain because her sides were blowing up in pain; Second dose: She had no red blood cells that could provide oxygen to her organs; Second dose: weak; Second dose: overproducing of her white blood cells; Second dose: wasn't acting like herself; Second dose: more tired; Second dose: she could hardly talk; Second dose: she couldn't stand up; Second dose: she lost control of her bowels; Second dose: hollow cough; This is a spontaneous report from a contactable consumer. A 96-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Mar2021 (Batch/Lot Number: EP6955) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included Leukaemia in 2018, High blood pressure with 40 years, Diabetes in 2016, Atrial fibrillation in 2018.The patient's concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (Batch/lot number: EN6199) in left arm on 07Mar2021 for COVID-19 immunization. She had just had her blood drawn in Feb2021 and her blood was ok. So on 07Mar2021 she received her first Covid 19 vaccine. At 96 years old, after the Covid 19 vaccine, her mother's body was full blown with leukemia. Radiation wasn't an option to stop the overproducing of her white blood cells. The Covid 19 vaccine just accelerated it. Maybe there are others out there in this condition and should be double checking to see if they should get the Covid 19 vaccine. On the 12Apr2021 or 13Apr2021 her mother started having a hollow cough. She wasn't congested but she continued to cough. She noticed her mother was breathing heavy and fighting to breathe on Friday, on16Apr2021. It wasn't getting any better and she thought her mother would have more trouble so she took her to the emergency room. She reported she took her mother to the hospital on 16Apr2021.She was admitted on 16Apr2021 and discharged on 18Apr2021. They gave her some oxygen and did some tests. They asked her mother if she had chronic obstructive pulmonary disease and she did not, they suggested that it was her atrial fibrillation. She has had atrial fibrillation in the past, her doctor did leave her on her atrial fibrillation medication. She can't recall the name of the atrial fibrillation medication. She was discharged home on 18Apr2021 and she was breathing ok on her own. But by that next Tuesday, 20Apr2021, she noticed her mother was declining. She wasn't acting like herself. On Wednesday, 21Apr2021, she was more tired and her difficulty breathing started back up. On Thursday, 22Apr2021, she called the ambulance to take her mother to the hospital. She could tell that her mother wasn't herself, she could hardly talk on 22Apr2021 , she couldn't stand up, she lost control of her bowels. She wasn't responding to her. The caller knew something was going on. They put oxygen on her mother and they transferred her to a cancer specialist hospital. That's when the doctor realized it was a leukoblast. Clarified with caller, leukoblast. Then her mother died. She died on 28Apr2021.The caller knows the hospital was doing tests to see what was causing her mother's pain, but she doesn't have that information. She heard the screams from her mother and there was no consoling her mother. The hospital gave her mother morphine and it didn't work. She has no product information for the morphine, it was given in the hospital. She was screaming for murder, screaming for help and was given the morphine. Within a month of receiving the Covid 19 vaccine her leukemia was back and her mother was screaming in agony and pain because her sides were blowing up in pain. Whatever the Covid 19 vaccine did in her body, her body thought it was fighting off something. She had no red blood cells that could provide oxygen to her organs. She was weak. Overproducing of her white blood cells on an unspecified date. The lab data included White blood cell count abnormal and Red blood cell count decreased. Outcome of her mother's body was full blown with leukemia/she wasn't responding was fatal, of remaining events was unknown. Treatment received for all events. The seriousness of event breathing heavy and fighting to breathe were reported as hospitalization from 16Apr2021 to 18Apr2021. The seriousness criteria of she wasn't responding was reported as hospitalization from 22Apr2021 to 28Apr2021.; Reported Cause(s) of Death: Fatal Neoplasm progression

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

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

Pt called to follow up on covid-19 vaccine done on 02/26/21. Denies any reoccurrence of lightheaded. Felt fine at home and over the weekend. He has chronic itching, not new after vaccine. Plans to call his pcp today to get scheduled to manage this further. Denies any further questions or concerns. Pt is appreciative of phone call. a 97 y.o. male who was seen at Clinic today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the left deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience lightheadedness. He denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, hypotension, rapid progression of symptoms, respiratory distress and vomiting. PMH includes htn and DM (diet controlled). Reports he ate breakfast around 7 am today. He had cheerios, cantaloupe, and coffee. He arrives to the bay using his own motorized wheelchair. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, malaise/fatigue, facial swelling, itching in ears, sore throat, frequent throat clearing, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches Negative for nausea: + lightheaded.: Previous Reactions: none Objective Vitals Vitals: 02/26/21 1131 02/26/21 1138 02/26/21 1155 BP: (!) 175/79 (!) 144/82 132/80 BP Location: Right arm Pulse: 89 64 SpO2: 98% Physical Exam Constitutional: General: He is not in acute distress. Appearance: Normal appearance. He is well-developed. He is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Eyes: General: Right eye: No discharge. Left eye: No discharge. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Right lower leg: No edema. Left lower leg: No edema. Skin: General: Skin is warm and dry. Capillary Refill: Capillary refill takes less than 2 seconds. Neurological: Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Great response to eating and drinking. Symptoms resolved. Pt monitored for total of 30 minutes. He feels well to go home. Wife with him. He was able to operate his electric wheelchair out accompanied by his wife. Follow up with pcp as needed.

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

On 3/26/21 it was reported that this pt had fallen in her apt., EMS responded and transported her to Medical Center. On 3/29/21, I followed up with hospital staff, then family and was told she tested positive for Covid via rapid test & PCR.

First day very tired slept all the time appetite decreased Dash day after not drinking not eating complaint of headache back pain which was generalized to the whole body with her alzheimers hard to tell very weak by noon could not walk from the living room to the bathroom Not eating or drinking that day had to have Neighbor come over and help move her she slept in a reclining chair for the night ? the next day she was doing better Was in touch with the doctor ? did not take her to the clinic or to the hospital but has she been any worse we would have

fatigue; Eyesight; Dizzy; bell's palsy; This is a spontaneous report from a contactable consumer (patient's son). A 97-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EN6207) intramuscularly in the right arm on 11Mar2021 at 14:00 as a single dose for COVID-19 immunization. Patient's medical history included glaucoma for more than 25 years - 'implants caser' (as reported), thyroid disorder for more than 25 years, eye disorder, and gastrointestinal disorder. The patient had no other prior vaccinations to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EN6201) intramuscularly in the right arm on 18Feb2021 at 15:00 as a single dose for COVID-19 immunization and experienced cannot focus with her eyes and full body aches and pains. Ongoing concomitant medications included timolol ("Timnol") drops for the eyes since more than 5 years, levothyroxine sodium (LEVOTHYROXIN) pill for thyroid since more than 20 years, and omeprazaole pill for stomach for 5 years. One week after the second injection (Mar2021), the patient experienced Bell's Palsy at 20:30, reported as serious for important medical event. On 12Mar2021 at 22:00, patient was dizzy and 'eyesight', both events reported as non-serious. It was further described as, "She saw patient over everything so she slept. Day after 2nd she had to had most of day as too Dizzy/fatigued to be mobile. Dangling/twisting side of face last 7 days ongoing." The patient did not receive treatment for Bell's palsy, dizzy or eyesight. The clinical outcome of Bell's palsy was not recovered, of dizzy was recovering, of eyesight was recovered on unspecified date, of fatigued was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021185916 Same patient, reporter, event, different vaccine dosing

Patient was admitted to medical facility on 7-12-21. She had fever, chills, nausea/vomiting, fatigue, shortness of breath, diarrhea, and light headed

Patient began to show muscle weakness in late afternoon on 1/31/21. On 2/1/21 she was unable to walk, not even one step. She had difficulty swallowing, was unable to feed herself, and was extremely lethargic. She was unable to remain awake all day and had to be shaken unusually hard to wake up. She appeared confused/ disoriented upon waking. She did not have a fever or report of any pain. Her BP, pulse, and O2 were all normal. She did present with any indications of a stroke. Slight improvement began late afternoon on 2/2/21. On 2/3/21 all of these conditions had disappeared and she was back to her normal self and activities.

Client's daughter described events to me. Stated mother experienced tingling, weakness in legs about 7-14 days after receiving 2nd Covid vaccine. Also spoke with client for a few minutes. Stated could only walk a few minutes then legs felt like they were paralyzed and became really hot feeling. States toes felt like they were curling under left foot. Daughter took mother (client) to ER on Feb. 17 (after this had been going on for 4 days). Client was not admitted to hospital. Client stated no adverse events noted with 1st Pfizer Covid Vaccination. Client & daughter stated that client had bladder infection 1 week after receiving 2nd Covid vaccination. Client states problem with legs improving each day.

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

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

Vaccinated for Covid-19 on 1/29/2021 and 2/18/2021. Symptom onset on 6/10 with fatigue, dizziness, vomiting, abdominal pain, shortness of breath and eventually fever. Tested positive on 6/13/2021.

health has totally deteriorated; She sleeps, barely opens her eye; refuses to eat or drink; dizzy; didn't feel well; she can't talk, walk or anything; she can't talk, walk or anything; She is weak and frail; This is a spontaneous report from a contactable consumer (patient's daughter). A 100-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 10Jan2021 at single dose for COVID-19 immunization. Medical history included dementia from an unknown date and unknown if ongoing and walking aid user from an unknown date and unknown (prior to the vaccine, she walked well with her walker). Concomitant medication included quetiapine. The reporter reported that the patient's health has totally deteriorated as of a few days after receiving the vaccine on 13Jan2021. She is dying. She sleeps, barely opens her eyes and refuses to eat or drink. Three days after receiving the vaccine on 13Jan2021, she said she was dizzy and didn't feel well. Now she can't talk, walk or anything. She is weak and frail. Prior to the vaccine, she walked well with her walker, ate well and had energy. The reporter visited with her and had conversations but the patient doesn't talk or respond. She is her daughter and POA. She lives in the facility due to dementia. No treatment was received for the events. The patient did not recover from the events. Information on the lot/batch number has been requested.

At 1:09 pm after client received her vaccine client states she felt lightheaded. Vital signs obtained by EMS BP 150/95, pulse 75, O2 sat 100%. At 1:15 pm client states she feels better. Advise to follow with PCP. Discharged home by EMS.

fall; This is a spontaneous report from a contactable consumer (patient's daughter). A 100-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9261) via an unspecified route of administration in left arm on 22Jan2021 at single dose for COVID-19 immunisation. There were no relevant medical history or concomitant medications (it was also reported that the patient was on a lot of different medications). The patient experienced fall on 16Feb2021. The patient was then "hospitalized for a fall" and might not be attend her second vaccination appointment. Her second dose was scheduled on 24Feb2021. The hospitalization had nothing to do with vaccine. The outcome of event was not recovered.

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

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

on 3/16/2021 lost feeling in both legs and was unable to stand - vital signs were normal - doctor's exam at 12:30 was unremarkable - this was 18 days post injection #1 on 4/04/2021 lost feeling in both legs again, was unable to stand, B/P was 220/122, posturing on left side, disoriented - week preceding was marked by uncharacteristic disorientation and anxiety and complaints of pain to light touch on skin, - week following was characteristic of recovery from mild stroke - now mental status is returning to normal, overall strength decreased - this was 16 days post injection #2