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.

MORNING AFTER VACCINATION, DEVELOPED VOMITING, DIARRHEA, HEADACHE, LOWER BACK PAIN, LEG PAIN, AND RASPY VOICE. WENT TO ER ON 1/21/21

Patient is a 90-year-old female. She is a nursing home resident with and ongoing COVID 19 outbreak occurring . She has been diagnosed with corona virus on 1/4/21. She apparently has not eaten or drank anything in about a week. She was being hydrated at the nursing home with normal saline, but has failed to improve. She was sent to the ER and was admitted on 1/8/21 to hospital At no time during the hospital stay has she been more than minimal responsive. She need O2 for Comfort but on CXR and CT cardiopulmonary imagining was clear. Discharge note stated that he was requiring supplemental oxygen, but her chest x-ray on admission actually showed no acute cardiopulmonary disease. She was diagnosed with COVID-19 on 1/4/21. Most likely, this disease set her level of function back to the point that she was no longer eating and drinking, and she just overall rapidly declined after that. There was no evidence of an actual COVID pneumonia or pneumonitis. On 1/12/2021 family made patient a DNR and IVF were stopped and switched to comforted care. Patient expired 1/13/21

following administration, pt had progressive diarrhea, hypoglycemia not responsive to eating/drinking requiring hospitalization (glucose as low as 31 - short D5W drip); workup for infection, thyroid, or adrenal cause all negative

According to medical report, Pt presented to the ED on 1/14/21 w/ cc of SOB for 1 day. She received her COVID-19 vaccine on 1/9/21. Pt stated that she developed a dry hacking cough 2 days prior to the vaccine on 1/7/21. Over the last few days prior to admission, she developed generalized weakness, SOB, loss of sense of taste and smell w/ associated decreased appetite and nausea ultimately SOB in the24 hours prior to admission. Final Diagnosis- acute hypoxic respiratory failure secondary to COVID-19 pneumonia. Pt died on 2/3/21. See Medical report for more information.

pt stated that she had SOB, muscle aches, diarrhea, nauseated for about 2 days. Pt is now feeling better and has not contacted PCP.

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

Emesis, swollen left injection site, altered mental status Unknown if related to vaccine per hospital record IV Rochephen and IV fluids

Having more severe stomach pain than normal. Interfering with ability to sleep at night. Visited urgent care this morning because of the pain.

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.

syncope followed by ER visit w/ many negative tests. persistent weakness, apathy and loss of appetite

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.

diarrhea/ Stools loose; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via an unspecified route of administration into the left arm on 30Jan2021 13:00 at a single dose for COVID-19 immunisation. Medical history included metastatic thyroid cancer and ventilator/oxygen/feeding tube dependent. Patient was not pregnant. Concomitant medication included metoprolol (METOPROLOL), furosemide (LASIX), valacyclovir (VALACYCLOVIR), bifidobacterium lactis (PROBIOTIC) and cetirizine hydrochloride (CETIRIZ). On 30Jan2021 13:30, patient experienced diarrhea; also reported as stools loose. The event was reported as non-serious and the patient was treated with loperamide. Outcome of event was recovering.

I felt sickish at stomach. Did not vomit but not hungry. Excessive amount of gas on stomach. Some coughing. My normal temperature is 96 or 97 but it measured 99 degrees then. This could have been a touch of something else but since it followed the shot, I felt that it was the probable source. I was also very tired. It lasted about 4 days.

Patient required hospitalization for COVID-19 Seen at an urgent care 2/24 for sore throat. Clinically dx'd w/strep and started on cefuroxime and prednisone Continued to decline with anorexia, dry cough , mild sore throat and weakness. Was taken to ED 2/27 and diagnosed with COVID pneumonia. Had mild hypoxemia requiring oxygen. She was admitted from 2/27-3/3. She was treated with 3 doses of IV dexamethasone and Remdesivir. Because of the length of time from second vaccination ID was consulted. They SARS-CoV-2 IgG testing. Pt was negative. Therefore the pt was treated with one unit of convalescent plasma on 3/1 for passive immunity. She was able to be weaned off oxygen on 3/1 and was discharged on 3/3 Additionally her SARS-CoV-2 nasal swab was sent to the health department for genetic sequencing

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

Patient began to complain about secretions on 2/1 and phlegm for days post vaccine. Following that she complained of upset stomach upset and large mucus. Loose stool followed on day 6 post vaccine, with continued large amounts of mucus.

1st Pfizer vaccination 1/21/21, lot # EJ1686. 2nd Pfizer vaccination 2/10/21, lot # DW8936. On 2/25/21 pt had decrease in meal intake and began refusing meals. On 3/1/21 was sent to hospital for rectal bleed

Hospitalized 3/26/21 for GI symptoms not associated with a COVID infection. Found to have an abdominal mass. Discharged 3/29/21

3/30/21 ER HPIHPI Patient is a 90 y.o. female who presents with with complaint of weakness and poor appetite. Patient also complained of cough productive of brownish sputum. Patient got her 1st Pfizer vaccine for coronavirus on the 18th of March (3/19) and tested positive on the 20 (3/21)March 2021. Patient was admitted to the hospital treated and discharged on the 26th of March. Patient has no fever or chills, no shortness of breath, no chest pain, no nausea vomiting, no headache or dizziness. Patient says she is weak in both legs and afraid of falling Admitted inpatient to Hospital 3/31 Dx: Pneumonia d/t Covid-19

3/24 arm pain, 3/25 rt shoulder and back pain, Tylenol given, 3/25 body aches and tired, Tylenol given 3/25 visit with dr to discuss pain- urinalysis ordered, later Tylenol and biofreeze, temp of 101 noted. 3/26 urinalysis results returned- NNO---- later 3/26This nurse is called to resident's room. Resident noted to have emesis of all bile, pale and lethargic. Complaints of not feeling well. Temp: 102.0, tympanic. Call placed to MA help nurse to update. Await call back .3/30 to dr again, confusion and bp issuesMercy ER, admit to hospital dx of cholecystitis.

Patient presented to the ED with CC of weakness. N/V, fever and SOB requiring oxygen. Mild left shift of total WBC, SARS-Cov-2 swab positive, CXR noted mild pulmonary vascular congestion and small bilateral pleural effusions. elevated troponins with no chest pain. diuresis was given and patient had improvement of symptoms of SOB. Patient was discharged to maintain isolation.

Delusions; Hallucinations; Psychosis; Cognitively, she is very bad; Dysphagia; Aphasia; Extreme lethargy; Brain fog; Confusion; Slurring speech to the point where it was very slurred; This is a spontaneous report from a contactable consumer (patient's granddaughter). A 90-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), intramuscular in left arm, on 18Feb2021 at 10:50 AM, at a single dose, for COVID-19 immunization. The patient's medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic or chromosomal abnormalities, endocrine abnormalities (including type 2 diabetes diagnosed years ago), and obesity. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 24Jan2021 at 90 years of age for COVID-19 immunization. There was no prescriber for the vaccine. About a week ago (Mar2021), the patient started experiencing delusions and hallucinations. The patient was currently hospitalized. These came on quickly, no definitive diagnosis. Over the last 2 months (2021), the patient slowly started slurring speech to the point where it was very slurred. In 2021, they took her to the emergency room (ER) and they did a battery of test including computerized tomography (CT) scan, blood test, urine, and magnetic resonance imaging (MRI) of brain. They were thinking maybe she might have had a small stroke but did not find anything. On Sunday (14Mar2021; within the last 2 weeks), the patient also had brain fog, and a little confusion, but was still there. The patient had no cognitive issues of any sort. On Tuesday (16Mar2021), the patient called and said there were some men at her house. The patient had the police go over and they said there was no one there and she started to say other things that did not make sense. On Wednesday (17Mar2021) at 03:00, the patient's granddaughter got a call from EMS that the patient reported someone broke into her home, stole her TV, and raped her. This was not true. By Wednesday (17Mar2021), the patient was in full blown psychosis with hallucinations, and delusions. The patient was hospitalized on Wednesday (17Mar2021) and the delusions, psychosis and hallucinations began between Sunday to Wednesday (Mar2021). The patient's granddaughter believes it all occurred after the vaccine. It was around the same time frame. The patient's granddaughter would notice a word here and there where the patient was slurring. The patient's granddaughter did not know if the patient was being lazy or tired and it gradually progressed. The patient's current state is in a very bad spot - cognitively, she is very bad (started on an unspecified date). The patient now has aphasia and extreme lethargy from 18Mar2021, and dysphagia from 22Mar2021. This has all progressed since she has been in the hospital. The psychosis came out of nowhere. The patient was on a whole laundry list of medications and does not know if they were relevant to this. The patient had just recently started experiencing some extreme changes to herself to the point where she is hospitalized. The medical team is not finding anything wrong with the patient medically. The patient has developed some psychosis and there is nothing else that has happened that would have caused it. The patient had both doses of her COVID-19 vaccine. The patient's granddaughter was trying to research it to see if has been reported by anyone else. The patient's granddaughter considered the events as non-serious. The patient had not recovered from the events.

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.

Patient presented to hospital 4/6/21 with rectal bleeding and subacute dysnpea on exertion/fatigue over the preceding several weeks and was found to have immune thrombocytopenic purpura (ITP) w/ platelet count of 1000. Anticoagulation was reversed (on warfarin at home for history of PE). Platelet count responded to steroids and TPO-agonists per typical ITP treatment. Incidentally, the patient was found to have H. pylori stool antigen + and commenced with quadruple therapy for this. Platelet counts continue to improve slowly w/ treatment.

02/21/21- Resident has been refusing meds and meal with continued poor PO nutritional intake, and lethargic. She continue to have periods of medication refusal and continued poor PO intake. 3/8 She developed shingles to her R buttock and was started on Acyclovir cream x7 days. She continues to decline medically. Admitted to Hospice on 3/12, poor PO intake and weight loss. 3/23 Resident passed.

Resident have had multiple PNA tx with IM Rocephin and IV Zosyn, Difficulty in swallowing, Elevated HCV RNA, 02/15 PCR Quant, ER visit following weakness and involuntary UE movements/jerking. Elevated amonia levels controlled with use of Lactulose. 02/22/2021 RUE and RLE extensive DVT. Worsening pressure wound and development of arterial wounds. Admitted to Hospice on 03/31/2021. Resident deceased on 04/03/2021.

She doesn't know what she weighs, it is going down so fast; She has a urine problem and urinates often; Don't have any appetite now/lost her appetite, even for water; Loose bowels; Voice is so dry/voice had also been affected; having a sleep problem, sleeping has been very bad; This is a spontaneous report from a contactable consumer (the patient). A 90-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6199) via an unspecified route of administration on 10Mar2021 at age of 90-year-old at single dose for COVID-19 immunisation. Medical history included the patient had cancer about 10 years ago, it went away and then it came back. Caller reported that it started showing up on her mammogram again. Concomitant medication included anastrozole taken for neoplasm malignant from 10Jan2021. Caller reported side effects from the Pfizer COVID vaccine. Caller stated that she didn't know if it was the vaccine or because of the cancer she has, but she didn't have any appetite now (onset date 24Mar2021). She was eating all right and taking the cancer drug, but on 24Mar2021 (reported as "about 2 weeks after the Pfizer COVID vaccine on 10Mar2021"), she lost her appetite, even for water. Caller reported that she could go two days without eating anything. At the same time she was having loose bowels. She didn't know if the loose bowels was from the medicine she was taking or something else. Her voice had also been affected, it was so dry, she couldn't even talk. The caller also reported that that she didn't know what she weighs, it was going down so fast because she was not eating since an unspecified date. Caller not sure about weight. Caller stated that she was having a sleep problem, sleeping has been very bad. Everything started about 2 weeks after she got the first Pfizer COVID vaccine on the 10Mar2021. Caller was supposed to go back for her second Pfizer COVID vaccine on the 31Mar2021, but on the 24Mar2021 she started having trouble with eating and sleep and loose bowels. Since symptoms started after her Pfizer COVID vaccine dose on 10Mar2021, she decided not to go back on 31Mar2021 for the second dose. Caller reported that she ate 2 French fries since 07Apr2021 (yesterday), from a sandwich she ordered yesterday but didn't eat the sandwich. Caller clarified that she couldn't even eat the 2 French fries and hasn't had anything since then. For loose bowels: caller reported that she had a urine problem and urinates often since an unspecified date. Caller stated that when she went to urinate and when she barely presses down, she would have a bowel movement, but it was very watery and loose, not a formed bowel movement. She talked to her cancer doctor and her regular doctor who both told her to go to the hospital but she did not go. For dry voice: caller reported that she didn't know if it was acid coming up in her mouth or just dry mouth. Caller didn't know what it was, if she kept her mouth closed and didn't talk and didn't get any air, it was not as bad. Caller reported that trying to talk was bad and it had recently gotten a little worse. The patient wasn't having these symptoms before she took the vaccine. The outcome of "she doesn't know what she weighs, it is going down so fast" and "she has a urine problem and urinates often" was unknown, the outcome of other events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

5/2/2021 - productive persistent cough and poor appetite. Received physician order to transfer to Hospital for evaluation.

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.

Diarrhea; Sore arm; This is a spontaneous report from a A contactable consumer (patient neighbour) reported that a 90-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC, lot, Expiry Date: Not provided), via an unspecified route of administration, on an unknown date (age at vaccination 90-year-old) as unknown, single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date, the patient experienced diarrhea and sore arm. Reporter states as, her old neighbour said she got Pfizer and she had diarrhea too. the patient had diarrhea and sore arm. The patient got hers, so patient was the first round of people. she doesn't think she has enough information to complete a report for her. The patient told her that she barely made it home in time before the symptoms started. Outcome of the events was unknown. Follow-up attempts are needed. Further information is expected.

Shaking, almost spasm type shaking. Weakness in her legs. progressing to abd. pain, cough, headache, nausea

Fine in Am. Started complaining of stomach pain in afternoon. Had dinner around 6 pm & threw up part of it along with clear mucus and all the water she drank. After that it was all clear mucus off & on through the night. Has had this episode before but only lasting a few minutes never this long! Tried to give water but kept coming back up. Meanwhile pain in stomach (pelvic area) was getting worse. Called 911 at 2 AM (see line 19). Sometime after 911 left, the clear mucus started coming at a faster rate. Had bowel movement around 6 AM but said no relief in stomach pain. Called at 8Am. Could not come til between 12-1 PM. Seemed weak and very tired so let sleep. Around 10-10:30 AM could not wake her up. Called 911 again. This time it was cardiac arrest and they could not revive her.

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

Immediately, felt burning at injection site, then mild headache, lips tingling. . About 40 minutes later, lips and tongue swelling, and uncomfortable swallowing.

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

Ears blocked, pressure in head, loss of hearing. Next day -pain in abdomine followed by diahrea - general not feeing well,

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.

This is a spontaneous report from a contactable consumer. A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: 31May2021), via an unspecified route of administration on 21Jan2021, 09:30 at a single dose on left arm for COVID-19 immunization. Medical history included oesophageal dilation procedure from 11Jan2021 to an unknown date and had trouble swallowing from an unknown date and unknown if ongoing. There were no concomitant medications. The patient received the first dose of the vaccine on 21Jan2021 and everything was pretty good. Nothing bothered her until yesterday, Sunday morning. Her throat is not sore but swollen. She feels it is in her tonsils, like her tonsils are swollen. When she gets ready to swallow it is hard sometimes, she can swallow but it feels like something is in the back of her throat like her tonsils are swollen. She has had headaches off and on. She asked if these were normal symptoms after the vaccine. Reported her second COVID-19 Vaccine is scheduled for 11Feb2021 at 9:30AM. Reported she had 3 negative COVID-19 virus tests before. She said each time she had the COVID-19 virus test done was before a scheduled procedure. She said her last negative COVID-19 virus test was on 08Jan2021 before a procedure on 11Jan2021. She clarified she had trouble swallowing and had an esophageal dilation on 11Jan2021. She said she was put to sleep for the procedure. Clarified she has had an off and on headache, a sore throat that feels like her tonsils are swollen, and a pain that shoots through her ear occasionally. She said all her symptoms started late on Saturday (23Jan2021) or early Sunday (24Jan2021). Reported she took 1 Tylenol Extra Strength 500mg capsule yesterday evening (24Jan2021). She said she does not have the box with the UPC number for the Tylenol Extra Strength 500mg capsule, providing: Lot Number: PBA023, and Expiration Date: Dec2022. Reported she left her COVID-19 vaccine paperwork at her daughter's house. She said her daughter read some of the COVID-19 vaccine side effects over the phone to her, but sore throat wasn't one of the listed vaccine side effects. She said she was calling Pfizer to find out if a sore throat was a side effect of the COVID-19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Jan2021. More information available (Y/N): No. Therapeutic measures were taken as a result of throat is not sore but swollen, headaches off and on and pain that shoots through her ear occasionally. The outcome of the event "throat is not sore but swollen", "headaches off and on" and "pain that shoots through her ear occasionally" was not recovered while of the other events was unknown.

Resident was given the Pfizer vaccine on January 22, 2021, nausea and shortness of breath was taken to the Hospital on the 23rd of January and passed on the 24, 2021

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.

diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 at 11:45 (at the age of 91-years-old) as a single dose in the left arm for COVID-19 immunization (tired of being cooped up in the house). Medical history included atrial fibrillation and patient had a pacemaker, both from an unknown date. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to vaccination. On 25Jan2021, at night, the patient experienced diarrhea and vomiting. The clinical outcome of the events diarrhea and vomiting was recovered on 26Jan2021 at 02:00 and she felt good. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Nausea; Diarrhea; Kind of not feeling good; Throwing up; This is a spontaneous report received from a contactable consumer (patient's daughter). A 91-year-old (also reported as 92-year-old) female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number and expiry date unknown), intramuscular on the right arm, on 25Jan2021 19:00, at single dose, to prevent covid/COVID-19 immunization. There were no medical history and concomitant medications. It was reported that the patient had the first shot of the vaccine on 25Jan2021 at 19:00 (yesterday). The patient was surprised that the shot did not hurt going in and she was not having any pain in the arm. On 26Jan2021 (this morning), the patient was experiencing nausea, diarrhea, was throwing up and was feeling kind of not good. The patient stated that the side effects were ongoing. No treatment was given for the events. The outcome of the events was not resolved. Information about batch/lot number has been requested.

she couldn't urine/She couldn't urinate anymore; she couldn't urine, patient tried for a long time in the bathroom and only got a few drops of urine out; Always had burning on bottom of her foot/she felt like her body was burning up in side/Felt like she was burning alive; Had a fever every day and every night/Temperature was 100 degrees; she has an infection in her bladder; feel like I am dying/had a very strange feeling in her body/Something was going across the top and right side like a fluid was flowing or something strange; sweating/wet, perspiring all night./Got all wet with perspiration; gotten more sick; weak; tired; headache; lost a little weight; Eats very little now; afraid; pain was around the bottom of the foot now it's on top of the foot and goes up to knee; uncomfortable; sneezes; diarrhea; cramps; constipation; colon cancer; doesn't think the needle went in all of the way when the nurse administered her vaccine; shingles; Post herpetic neuralgia/the post-herpetic neuralgia was on her whole foot; pain at the bottom of my foot; impact on the nervous system; This is a spontaneous report from a contactable consumer (patient). This 91-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EN5318), via an unspecified route of administration on 02Feb2021 at single dose in the left arm for COVID-19 immunization. The patient medical history included high blood pressure, kidney cancer, cancer in her bladder 20 years ago and coughing. The patient's concomitant medications included ergocalciferol (VIT D), ascorbic acid (VIT C), losartan potassium for blood pressure, metoprolol succinate for blood pressure, amlodipine for blood pressure, acetylsalicylic acid (ASPIRIN 81). Patient had cancer in her bladder 20 years ago. That was taken care of. Had kidney cancer because her husband used to smoke and blow it in her face. Had rare type of kidney cancer. It was removed. Treated for bladder cancer. Patient has had no problem ever since and that was more than 18 years ago. Patient had a fever, headache, and was very tired. Burning up on side of the body and she got all wet. This was not normal and she felt like she was dying. Patient stated she had shingles and developed post herpetic neuralgia. Patient always had pain at the bottom of her foot but it was getting worse after she received the first dose of Pfizer COVID-19 vaccine. Patient noticed the liquid going thru arm to chest and in straight line to her leg, like a science fiction movie with an injection of some kind. The doctor thought the vaccine might have an impact on the nervous system and spike the symptoms of post herpetic neuralgia. Patient spoke to her doctor but nobody knows anything. Nobody was willing to help her. Patient felt like she was dying. She didn't want to die. Patient feel the symptoms are getting worst. She was burning up inside. Her pain was around the bottom of the foot now it's on top of the foot and goes up to knee. Patient was not blaming anybody but she thought it was the vaccine. Patient was sweating, wet, perspiring all night. The symptoms usually occur at night. Patient wanted to know if these symptoms were associated with the vaccine. Patient also mentioned she developed a bladder infection for which she was taking antibiotics. Patient had Pfizer vaccine on 02Feb2021, about 5 days ago. Patient followed instructions before vaccine. Doctor said to take paracetamol (TYLENOL) before the vaccine for a headache. Patient did that. Patient had injection and told to wait for 15 minutes before she went home. About 5 minutes, she was relaxed and sitting down. Vaccination given in left arm. All of a sudden she had a very strange feeling in her body on 02Feb2021. Something was going across the top and right side like a fluid was flowing or something strange. Then it felt like a straight line down her right foot and it stopped. Was a feeling like maybe the liquid of the vaccine went that way. Didn't have a vein going that way. Patient was afraid. She went home and didn't remember the next thing that happened. Every night she has gotten more sick. Patient had a feeling in her foot where she had shingles a few years ago. After shingles had post-herpetic neuralgia. Patient always had burning on bottom of her foot and would put it in ice water. Patient could handle that because it was just uncomfortable. After injection, she got so bad, the post-herpetic neuralgia was on her whole foot and it started to burn. It went up a little towards the knee or higher. Yesterday, at times, it quickly went over to the left leg. Patient had a fever every day and every night. Patient took paracetamol to cut the fever. Patient was coughing on call but stated that was nothing and the coughing was something she had. Every night she felt like her body was burning up in side. Felt like she was burning alive. Got all wet with perspiration. She changed clothes and every night it got worse. Patient called emergency, they listened to her, stating they have never heard of anything like this. Asked patient if she wanted to go to emergency. She stated ok. The doctor listened to her story and told her it was weird. Doctor told her to give it a few more days to up to eight days. Doctor wanted her to get a urine test, but she couldn't urine, patient tried for a long time in the bathroom and only got a few drops of urine out and it was brown. Not normal urine. Next day patient called 911. She wanted to be assured she was not dying at home. Did have room available at the hospital. Patient had to sit in a wheelchair and there was no bed for her to lie down in. Last time she was admitted from the emergency. Next day she came home and had to call emergency again. Really thought she was burning up. Patient didn't want to go to the hospital and suffered at home. Next night and third night was so bad. Patient couldn't urinate anymore. She had a fever, but not a high fever, because the paracetamol cut the fever. Temperature was 100 degrees. On the inside she thought she was being burned up a live. Never got better, always got worse. Yesterday, she was in the hospital all day. Now she has an infection in her bladder. Was put on a machine and everything. Had a long procedure, and got the urine going. Patient didn't miss not urinating. Has accidents like when she sneezes or cough. Usually gets up 2-3 times at night to urinate. When she finally realized she couldn't urinate, the doctor kept her there for a long time, eight hours. Was put on the machine, thought she may need a catheter. Her bladder was massaged in order to get her to urinate. Patient only had the left kidney. Correct problem about the urine. Doctor told her to make sure she goes back for second dose on 23Feb2021, but she was afraid. In the morning she was a little better, couldn't handle this. Patient was very weak and tired. One night she was in the emergency and didn't sleep because of the procedures. Patient didn't think the needle went in all of the way when the nurse administered her vaccine. Sensation started on the left, went across her chest, straight down like an arrow. Like something was trickling down to the end of her foot and stopped. Patient had symptoms every night since. So severe patient thought she was burning up. Patient got worse every night and didn't get any better. Patient said feeling at COVID-19 Vaccine injection site was not a natural thing. Last time she was in the hospital her blood pressure went up to 184. After COVID-19 Vaccine patient lost a little weight. Same time had this problem, was seeing a doctor with a colon specialty. Had so much constipation for a long time and tried to correct it with mediation. Medication was too strong and gave her diarrhea. Doctor thought maybe she had colon cancer. Stopped the medication. Wasn't 100% healthy, but that was just cramps. Patient eats very little now, not very hungry. Patient feels good in her bowels after something good from a restaurant. Patient attempted to clarify the medication that was too strong. She stated it was over the counter. She stated it was something that had to be mixed. She was supposed to take a cap full and mix it with 8 ounces of liquid. Needed something to make her have a bowel movement. Only took it for two days. Was way before the vaccine. It was too strong and she stopped it. Patient took a probiotic. After that patient was given gas relief medication called: Gas Relief Extra Strength Simethicone, 125mg. Provided: V11496, MSRS 53041 REV 0417, and 883928. Patient no longer has constipation. Now it is the opposite. Now bowel movements are soft and pasty. Patient tried a stool softener that didn't work, was worthless. Was over the counter. Patient didn't take stool softeners after the COVID-19 Vaccine. All the events started from Feb2021. Outcome of the events was unknown.

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

Blood sugar has gone up/Blood sugar started increasing; Burning in chest; Had trouble keeping head up; Nauseous; Pain between shoulder blades; Pain at injection site; Did not feel good; Heartburn; Bones hurt worse than usual; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269, Expiration Date: 31May2021) intramuscularly, administered in left arm on 12Feb2021 at 14:55 (at age of 91 years old) at a single dose for COVID-19 immunization. Medical history included type 2 diabetes (Diagnosed 15-16 years before this reporting), high blood pressure prior to that. She lost a lot of weight since she found out she was diabetic, which was prior to getting vaccine, around 15-16 years before this reporting. She lost 50 lbs in 15 years. It has been gradually. She gets Prolia shots and did not get one this month. She has scoliosis and osteoporosis and that was one of the things that happened. She had previously broken her shoulder blade and some ribs on her right side. She confirmed that she broke it over a year before this reporting. She has a yellow mark and a little reddish mark that looks like someone hit you. It is still there and it is a fading black and blue mark and does not hurt any more. She takes blood pressure medicine. She does not take diabetic medication. She did in the past, but it caused her ankles to swell and then she started controlling it with diet. She was right handed and had trouble trying to do things with her left hand. This started prior to the vaccine. Family medical history included: Family heart issues and diabetes. Heart disease and cancer in the family. There were no concomitant medications. The patient previously took Prolia for back problems. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261, Expiration Date: 31May2021) on 22Jan2021 at age of 91 years old at a single dose for COVID-19 immunization. She didn't have any problems after the first COVID-19 Vaccine. No additional Vaccines administered on same date of the Pfizer Suspect. The patient experienced blood sugar has gone up/blood sugar started increasing on 15Feb2021 at 08:00, pain at injection site on 12Feb2021 at 14:55, pain between shoulder blades on 12Feb2021 at 20:30 to 21:30, had trouble keeping head up on 13Feb2021 at 07:30, nauseous on 13Feb2021 at 07:30, burning in chest on 13Feb2021 at 08:30, did not feel good on 12Feb2021 at 08:30, heartburn on 12Feb2021 at 08:30, bones hurt worse than usual on 12Feb2021 at 07:30. She has stated her blood sugar has gone up since she's received the second dose of Pfizer's COVID vaccine on 12Feb2021. Blood sugar started increasing was reported as worsened. She was type 2 diabetic and does not take any medicine. She got second shot on 12Feb2021, and her sugar was 89, then she started not feeling good the day after. On 15Feb2021, she was checking it and it was 119. On 16Feb2021, it was 145. On 17Feb2021, it was 144, and 18Feb2021, it was 145. She had never had them this high. It does not mention it can do anything to your sugar. She does not know her height. Last she was measured was 4'6"-4'7". Her highest was 5 feet. This was prior to the vaccine. She said her weight was between 80-85 lbs. The second shot hurt when they gave it to her. About 6 hours later, it felt like she was hit by lightning between her shoulder blades. She had previously broken her shoulder blade and some ribs on her right side. That has been bothering her and it felt worse when she got the vaccine and she could hardly lift her head up. The pain went from her left shoulder blade to right shoulder blade and stopped right away and then it felt like a lightening thing. She had trouble keeping her head up. She still has trouble with shoulders and is putting heating pads on them. She felt nauseous off and on. Her bones usually hurt, but after the second injection they hurt worse. As long as she puts heat on them, it feels better. The second dose feel like it hit the bone. The first one did not feel that way. The outcome of the event "Blood sugar increased, Chest burning, Feeling abnormal, Heartburn, Bone pain" was not recovered, for events "Shoulder blade pain, Heaviness of head, Nauseous" was recovering, for event "Vaccination site pain" was unknown.

3/16/2021 Reaction from Pfizer second shot: I received the second Pfizer vaccine on Tuesday, February 23rd, 2021 around 1PM. Early Wednesday morning I developed Gastric reflux which I never had before. As the day progressed I had severe abdominal pain that lasted throughout the day, also something I never had before. Nausea set in late that evening. Although Thursday was fairly stable, on Friday I developed black diarrhea that continued all day. By Sunday I was so weak that a nurse came and sent me to hospital via ambulance. After 4 days of blood tests, transfusions, a chest x-ray, heart monitor, endoscopy and colonoscopy etc. , the only diagnosis for the significant blood loss was a bleeding ulcer. This must have been developing on Wednesday when the severe pain began. After release from the 4 day hospital stay, I was sent to our health clinic for 6 days to regain some strength. Since I never had ulcers, I firmly believe that everything was activated on Tuesday when I received the second Pfizer vaccine shot. Please advise on your perspective of my situation. Is what I have described similar to others who have reported vaccine side-effects? Thanks and be well.

By Sunday I was so weak; I developed black diarrhea; Wednesday (day after vaccine) I developed Gastric reflux which I never had before.; As the day progressed I had severe abdominal pain that lasted throughout the day; Nausea set in late that evening; bleeding ulcer; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Feb2021 13:00 at single dose for COVID-19 immunisation. Facility type vaccine was Nursing Home/Senior Living Facility (as reported). Medical history included high blood pressure, aortic valve replacement and stent placement, 1 kidney, cancer 12 years ago (2009). Patient was not pregnant, no known allergies. No covid prior vaccination. No Covid tested post vaccination. No other vaccine in four weeks. Other medications in two weeks was yes (blood pressure medication). Concomitant medications included unspecified blood pressure medication. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in left arm on an unspecified date for COVID-19 immunisation. Patient reported that on Wednesday (day after vaccine) (24Feb2021) she developed gastric reflux which she never had before (24Feb2021 08:00). As the day progressed she had severe abdominal pain that lasted throughout the day, also something she never had before. Nausea set in late that evening. Although Thursday was fairly stable, on Friday (26Feb2021) she developed black diarrhea that continued all day. By Sunday (28Feb2021) she was so weak that a Harrogate (senior living complex) nurse came and sent her to hospital via ambulance. After 4 days of blood tests, transfusions, a chest x-ray, heart monitor, endoscopy and colonoscopy etc. , the only diagnosis for the significant blood loss was a bleeding ulcer. This must have been developing on Wednesday (24Feb2021) when the severe pain began. After release from the 4 day (as reported) hospital stay, patient was sent to health clinic for 6 days to regain some strength. Since she never had ulcers, she firmly believed that everything was activated on Tuesday when she received the second Pfizer vaccine shot. Adverse events resulted in: Emergency room/department or urgent care, Hospitalization (as reported), Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). Number of days hospitalisation was 3 (as reported). Treatment included blood transfusions and intravenous (IV). The outcome of the events was recovered. Information of lot/batch number has been requested.

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)

Temperature on arrival was 97 degree 18 minutes after the vaccination it was 103.4/six days running a 100degree fever; my blood pressure went to 170/100; my oxygen dropped to 88%; vomiting; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient (non-pregnant) received first dose of BNT162B2 (FIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in right arm on 02Feb2021 09:45 AM (at the age of 91-year-old) as single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease/COPD, asthma, hypertension. The patient has no known allergies. Concomitant medications were not reported. Patient took unspecified other medications within two weeks of vaccination. No other vaccine in four weeks. Patient was not tested positive for Covid prior vaccination. On 22Feb2021 at 10:15 AM, the patient experienced vomiting, blood pressure went to 170/100 and oxygen dropped to 88%. She was in bed end of the care of her daughter for six days running a 100 degree fever. Temperature on arrival was 97 degree 18 minutes after the vaccination it was 103.4. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient was not tested positive for Covid post vaccination. No treatment was taken for events. Outcome of events was recovered in 2021. Information about lot/batch number has been requested.

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.

Severe diarrhea; This is a spontaneous report received from a contactable consumer reported for herself. A 91-year-old female patient (non-pregnant) received first dose bnt162b2 (batch/lot number: unknown, brand: Pfizer, Solution for injection) via unspecified route of administration in left arm on 27Jan2021 at 12:15 PM at single for covid-19 immunisation at hospital facility. The patient did not have any allergies to food or other products and relevant medical history was reported as none. The patient concomitant medications were not reported. The patient did not receive any other vaccines 4 weeks prior to administration of COVID vaccine and any other medications within 2 weeks of administration of COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 28Jan2021 at 17:00, the patient experienced severe diarrhea. The patient did not receive any treatment for the same. No seriousness criteria reported. Outcome of the event diarrhea was reported as recovering. Information about batch/lot number is not available. Follow-up attempts have been completed and no further information is expected.

gets confused and her personality changes; gets argumentative; burning urination/UTI; burning urination/UTI; diarrhea; chills; 99.7 degree Fever; shaking; feeling tired/Tired rest of day; This is a spontaneous report from a contactable consumer (Caregiver called in behalf of her mother in law (Patient)). A 91-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205, Expiration date was not reported), dose 1 via an un-specified route of administration, administered in Arm Right on 06Mar2021 13:00 (At the age of 91-years-old) as single for COVID-19 immunisation. The patient medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. She has Congestive Heart failure and a lot of allergies. Diagnosed with allergies over the years. Not to any vaccine. Arthritis diagnosed 10 years ago. She is on medication for Cholesterol- Diagnosed for that is unknown. more than 4 years. On an unspecified date the patient fell and broke her hip last summer they had caretakers for her (She had the fall be-fore the vaccine. It was last summer, but it does not have anything to do with the vaccine. No further details provided.); Family medical history: none. The patient Concomitant medications included warfarin (2mg a day, It changes based on her INR. No further details) taken for Blood thinner (She has been on it for at least 4 years). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced during the night chills on 07Mar2021 03:00 She did not notice anymore chills, diarrhea on 11Mar2021 19:00, burning urination/UTI (Urinary Tract Infection) on 17Mar2021 08:00, feeling tired/Tired rest of day on 07Mar2021, During the night 99.7-degree fever on 07Mar2021 03:00, shaking on 07Mar2021 03:00. Reporter not sure if patient can get to her appointment for the 2nd dose on 27Mar2021. Patient was visibly shaking when she woke up at 3am and did not wake reporter up until 6am. she had 4 good days and then had diarrhea. She had another good day and then went into a UTI. She does not know if they had anything to do with it or not. she gets confused and her personality changes. With her UTI, patient gets confused and her personality changes. She gets argumentative. With her heart failure and age, it was good for her to have the vaccine. She has had congestive heart failure for years and is on blood thinners. She also takes 10 other medications. She takes blood pressure medications and vitamins. She did not think they were relevant. No further details provided. If she wants to reschedule, does she need to wait a certain number of days after she finishes the CIPRO. 17Mar2021, she asked for a specimen cup and took a urine sample to their office. The patient under-went lab tests and procedures which included body temperature was 99.7 degree on 07Mar2021 (03:00). Patient received treatment of tylenol for chills, 99.7-degree fever. Tylenol as part of her nor-mal regimen. On 18Mar2021, she knew that she had it (UTI) and she called the doctor and he gave her Cipro (ciprofloxacin) antibiotic (it was in a pharmacy vial. Unknown dose), which she has been on since 18Mar2021. She was tired the rest of the say day. She takes Tylenol as part of her normal regimen. No further details provided on the Tylenol. She did not notice anymore chills. There was not a prescriber. She had it at (Pharmacy name). It was reported that the patient was tired and wanted to reschedule her appointment for second shot. Patient will be on the CIPRO until 28Mar2021. Her next shot would have been 27Mar2021. Reporter wanted to know if the ciprofloxacin will have an effect on the vaccine. Asking if ciprofloxacin will have an interaction with the COVID 19 vaccine. Reported does not want the patient to go through with getting the shot if it will not be any good. Reporter stated that, Tired rest of day - Unable to confirm start time. She never recovered from fever and diarrhea (it was off and on until 15Mar2021) and was tired the rest of the day. She later stated fever and diarrhea were improved. The outcome of event shaking, she gets confused and her personality changes, She gets argumentative were unknown; outcome of rest of all events were recovering at the time of this report. No follow-up attempts are possible. No further information is expected.

Patient presented to ED for abdominal pain, nausea and vomiting. during CT of the abdomen and pelvis a finding suspicious for DVT in the left external iliac vein and left common femoral vein. External venous doppler was done to confirm DVT. impression : Acute DVT throughout the left lower extremity extending from the left lower calf to the left common femoral vein. Patient has been admitted to Medical floor for care

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.

Was contacted by the person's daughter on 2/5/21. Patient started vomiting 2 days after vaccination. She aspirated and passed away 1/16/21. Patient had history of stroke and swallowing problems.

Pt had mild dementia prior to vaccine. Was able to walk, toilet herself, feed herself,. After Vaccine pt became bedbound within 12 hours, markedly confused, and anorexic

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.

DX: CVA History The patient is a 92 y.o. female with a past medical history notable for History of CVA, history of arthritis, history of COPD, history of DVT, history of reflux, history of hypertension, history of hyperthyroidism, recent GI bleed. The patient presents for evaluation of worsening weakness at skilled care facility. Patient had history of stroke. Patient was assessed there was found of have another stroke. Patient's other care and therapies were reviewed. Patient's blood thinners recently stopped within the last 3 months due to GI bleed requiring multiple transfusions. Patient has been slow to recover. Patient has struggled with intake and weight loss. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.

DX: Ileus Chief Complaint: Coffee-ground emesis, bowel obstruction Source of History: Patient History The patient is a 92 y.o. female with a past medical history notable for COPD, dementia, history of DVT, reflux, hypertension, hypothyroidism, recent small bowel obstruction. The patient presents for evaluation of Worsening issues of coffee-ground emesis once more. This is very similar patient's last hospitalization were patient required NG to and monitoring for blood loss. Patient continues to be confused and not a good source of history. Staff notes that patient started this 1 day prior at skilled care facility was sent into the ER. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient shows no signs of any pain or discomfort

feelings of unease developed about 22 hours post vaccine,, abour 2:30 pm, series of five vomits took place, ending around 6pm. One diarrhea event at around 3 pm. No fever, no appetite. Feeling weak, tired. Worry of dehydration. Given small sips of water with diluted lemon/lime soda every 10 minutes ore so for two hours at least beginning at 7:30 pm.

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.

Patient was taken by ambulance to E.R. 3 days after injection with bleeding from the nose and blood in stool. Spent 10 days in hospital. Returned to ER a few days later with fluid leaking from arms and legs. Diagnosed with congestive heart failure. Sent home under Hospice. Returned to ER, by ambulance, 36 hrs. later. Still weeping from skin and placed in ICU. on Bipap machine . Transferred that evening to medical Care Center where she passed away on March 3, 2021.

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.

Patient received vaccination with no immediate reaction. Approximately 3-5 minutes later after the patient was helped to the observation area, the patient told her son that she was very hot. Her head then slumped forward and she became unresponsive to verbal and physical stimulation. Patient also threw up while unresponsive. She almost fell out of her chair onto the floor, but was caught before hand. When patient became unresponsive, emergency medical services was contacted and a dose of epinephrine was going to be administered. The training EpiPen was used so a dose was not administered. Patient recovered within a couple of minutes and paramedics arrived to evaluate patient.

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

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Confusion-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient recieved vaccine and was helped to observation area. About 3-5 minutes after vaccination the patient told her son that she felt hot and then her head slumped forward. She became unresponsive to verbal/ physical stimulation. Patient vomited and would have fallen out of her chair if she had not been caught. She also made some noises from her throat that sounded concerning. EMS was immediatly called and epinephrine administration was attempted. Epi not given. Pt recovered and taken to ER.

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

12 Days later, Nausea, Vomiting, Cholecystitis. Hospitalized July 24, 2021. Currently still hospitalized. This may not be due to the COVID-19 vaccine BUT my Mother was fine prior to the shot and the proximity of her severe illness is very suspicious. Currently, she better but she is still hospitalized (6 days). She has never been in the hospital this longer than 2 days for tests and observation. Because of her age Surgery is a risky option. I am requesting research be done to discover others with Gastric issues after Pfizer's COVID-19 Vaccine. I, personally, another Pfizer COVID Vaccine recipient with severe stomach pain since her Pfizer shot a few mos ago. There's another friend (healthcare worker) who has been experiencing a sense of malaise since her Moderna shot 3 mos ago.

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

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.

Admitted 1/14/21: Patient is an elderly 93-year-old female with multiple medical problems including chronic combined CHF, P 80, diabetes mellitus, HTN, hyperlipidemia, CKD stage 3, has been complaining of generalized weakness, fatigue, decreased appetite for the past few days. She had an outpatient COVID-19 vaccine earlier today. Within 2 hr of admitting the patient to the hospital, condition clinically deteriorated. Patient elected to be DNR/DNI while in the ED. Patient was pronounced dead at 10:30 p.m. earlier today. Preliminary cause of death: Hypoglycemia induced lactic acidosis.

bad headache for 2 days, stomach ache for half day the first day , chills off and on the second day, muscular aches the second day, extreme fatigue for 2 days.

Severe diarrhea and dry heaves about 22 hours after second Pfizer vaccine. Lasted for approximately 3 hours. Slowly gaining strength back 48 hours after shot.

During injection she felt it burning; Her Blood Pressure went up to 255; She felt weakness and Nausea; Became unaware of her surroundings.

Chills began the same evening of vaccine. Nausea, loss of appetite, fatigue, started the following morning. Some mild diarrhea lingered two days following vaccine.

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.

Exhaustion- continuing Chills-continuing Severe Mental Fog- some improvement Loss of taste- somewhat better Loss of Appetite- some improvement in the last few days Overly cold in general Generally debilitated - continuing

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.

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.

The patient presents with generalized weakness and fever. She has been feeling weak in general for past 2 days. She developed fever (103F) today. She also has a decrease appetite. She does not have any pain. She denies any chest pain, headache, sore throat, abdominal pain. She denies any cough, shortness of breath, vomiting, diarrhea, or dysuria. She does not have any sick contact. She received Pfizer COVID-19 vaccination about a week ago. Since then, she has been feeling slightly weak and fatigued.. Given fluids and discharged to home stable.

A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 26Apr2021 at 10:00 (Batch/Lot number was not reported)(at the age of 93-year-old) as single dose for COVID-19 immunisation. Medical history included anaphylactic shock and blood cholesterol abnormal, both from an unknown date and unknown if ongoing and total knee replacement in 2009. Concomitant medications included simvastatin taken for blood cholesterol abnormal, start and stop date were not reported; furosemide (LASIX) taken for diuretic therapy, start and stop date were not reported and potassium taken for an unspecified indication, start and stop date were not reported. The patient reported that around on 26Apr2021 at 21:00 she experienced diarrhea. She said that she has had it 8-10 times, and she was just a little bit nauseous. The patient outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

This is a spontaneous report from a contactable consumer reported for herself that. A 93-years-old non-pregnant female elderly patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247), via an intramuscular route of administration at Right arm on 27Jan2021 12:00 PM at a single dose for COVID-19 immunization. The patient's medical history included high blood pressure, hiatal hernia, inguinal hernia and Allergies: shellfish. Concomitant medications reported as losartan potassium (LOSARTIN), levothyroxine sodium (SYNTHROID), omeprazole (PRILOSEC). On 03Feb2021 07:00 PM, Patient experienced Mild nausea. '3" on a scale of 1-10. No treatment received for the event. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient has not been tested COVID-19 before the vaccination. Seriousness of the case reported as non-serious. Patient has not been diagnosed before vaccination. Outcome of the event was unknown. No follow-up attempts are possible. No further information is expected

WORSENING delirium in addition to her memory loss since being admitted to Hospital (APRIL 2021 and May 2021). Workup at the hospital was negative for infectious process, dehydration or stroke. She was discharged to geriatric psych facility for 1 week, with no improvement in symptoms. Family has seen symptoms of delirium prior to hospitalization, such as hallucinations and paranoia. Since these hospitalizations patient is experiencing further paranoia, refusing to eat or take medications provided by her sons, as she thinks they are "trying to poison me". Her first hospitalization was within 24hrs of first injection, the second hospitalization was within 24hrs of her second injection

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.

over about an hour increasingly achy, arm pain, fever, nausea, high blood pressure, lower lip numb (sometimes a sign of a TIA), some confusion (sometimes the sign of a TIA) The severe nausea came in waves, lasted a couple of hours and cleared by Midnight before she went to sleep.

Patient began feeling nauseated on 1/18/21 around 6pm, and had uncontrolled diarrhea, reported that she did not feel right. Staff reported to this writer, that her skin tone was gray in tone and she just didn't look good. She was transferred to the HOSPITAL ER VIA AMBULANCE.

1/18/2021- Tested positive for Covid-19. 1/20 Patient lethargic, unable to swallow. 1/24 Although 90% O2 sat on RA, it has decreased from her baseline ranging at high 90's. 1/27/2021 Patient passed.

emergency room HPI A 94 y.o. female who presents with complaint of generalized weakness for one week. She had her first covid vaccination one week ago also. She denies fever, chills, body aches, dyspnea, cough, nausea, emesis, abdominal pain, diarrhea, urinary tract symptoms. She does have some anorexia.

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.

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

March 22 and March 23, 2021 belly pain, nausea, vomiting of digested blood (emesis appeared as coffee grounds), not able to keep ingested food down. Stool appeared normal as solid brown without red, black or tarryness. March 24 nausea/vomiting resolved but remaining anorexic. March 27 urine now appears darker (possibly due to dehydration). Patient remains anorexic so not eating well, minimal drinking, urine remains darkish. April 2 urine now with frank blood. Blood not rectal as patient has colostomy and not vaginal as patient Hx of hysterectomy. April 2-4 frank red blood. April 4 now urine burgundy. April 6 urine now cola-colored. Seen by physician. No UTI.

Patient experienced generalized weakness, nasal congestion and decreased appetite on 4/14/21 and was tested for COVID-19 infection. Symptoms worsened and patient presented to emergency department. Patient was admitted to hospital for treatment of COVID-19 pneumonia.

pt received her 2nd pfizer covid 19 vaccination on 4/1/21. she presented to the er on 4/16 with family with c/o 3 days of poor oral intake, diarrhea, weakness and confusion. family reported deterioration over the last 2 weeks. she was initially hemodynamically stable in the ER initially then became bradycardic and hypotensive. oxymask was placed. blood work revealed neutrophilia, anemia, mildly elevated ast and a markedly elevated troponin. she was admitted with non ST elevation MI, acute encephalopathy which ultimately progressed to coma, acute renal failure, progressive thrombocytopenia. cardiology saw her. she was started on a heparin drip. infectious cause for her symptoms was not found. her ef was 40% on echo. she expired on 4/20/2021.

Patient admitted on 03/25/2021 through the emergency department for complaint of shortness of breath she was a resident of a Nursing Facility. Her oxygen saturations were into 80%. Patient was poor historian her daughter at the bedside provided most history. Patient with recent admissions for coronavirus on 03/03/2021 and then again on 03/05/2021 for post coronavirus pneumonia. Throughout hospitalization patient with poor appetite, on 03/28/2021 noted to be somnolent, additional blood cultures and labs checked. Patient continue to decline, refused medications. Minimal responsiveness on 04/01/2021. Had episode of PAF on 4/1/21, renal dosed Eliquis per Cardiology. Service discussed with family multiple times about code status, he continued to be on decided home willing to change code status. Patient remained on high-flow oxygen and not eating. Patient very anxious increase work of breathing. Patient died on 04/03/2021.

Delirium, confusion, anxiety, and depression Nausea, no appetite headache, body aches pale, flushed cheeks Low blood pressure

Getting hot and cold; Gets hot and sweaty; Does not feel like doing anything, feels lazy; Hungry and eating like crazy/has been more hungry and eating more; 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: EL3246, expiration date: 30Jan2021) via an unspecified route of administration on the right arm on 09Jan2021 at a single dose for COVID-19 immunization. Medical history included walks with a walker, both knees replaced a year ago on 11Mar2020 (prior to receiving the vaccine), she had the mucus in her throat and a little bit of a cough prior to getting the vaccine. She had allergies. She normally has the mucus and cough in the morning when she gets up. She is also blowing her nose a lot. There were no concomitant medications. The patient was starting to get hot and cold. She was unsure if she has a fever as she does not have anything to measure it with. She gets hot and sweaty. She feels good but is hungry and eating like crazy on 09Jan2021. She is talking and breathing fine. Getting hot and cold and hot and sweaty: Happened a few days after the vaccine. She was unsure what day, maybe the day before yesterday, or yesterday and today. Yesterday she took a shower and she also took some guaifenesin (MUCINEX). This made her feel better. For example, she had lunch a while ago and she did not feel like doing anything. She felt lazy. She usually swims at 6 AM Monday, Wednesday, and Friday, and she did not go. Her friend said this was not like her. She also did not want to shower yesterday. She kept putting it off and then she finally showered and felt terrific. Her body felt like her body. She has always been a good eater, but since the vaccine she has been more hungry and eating more. Right now, she is starting to get warm as she is talking. It will go away and come back a little while later. Outcome of the events 'getting hot and cold' and 'gets hot and sweaty' was recovering and not recovered for the other events.

Coughing; Wheezing; Vomiting; Loss of appetite; This is a spontaneous report from a contactable consumer (daughter) reported for her mother that a 95-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left upper arm, on 20Jan2021 at single dose for covid-19 immunization. Medical history included atrial fibrillation in last 2 months in 2020 and ongoing; pacemaker inserted from 2020 to 2020, inserted about 2 months ago, also mentioned approximately Oct2020. She just had her second follow-up related to this day before getting first dose of Pfizer COVID-19 Vaccine. No notable results or information from that follow-up appointment. broken hip in Oct2020 and surgery for broken hip performed on 27Oct2020. The patient's concomitant medications were not reported. This daughter is the caregiver for her mother but is not a healthcare professional. She reported her mother was administered the first dose of Pfizer COVID-19 Vaccine on 20Jan2021. Starting 22Jan2021 around 08:45 she had onset of coughing; wheezing; vomiting; and loss of appetite. She wanted to know if these events could be related to the Pfizer COVID-19 Vaccine. Events outcome described as improved; the patient's nurse reported to daughter that they have subsided at this time. No adverse events required a visit to emergency room or physician office. No additional vaccines administered on same date of the Pfizer suspect. Patient did not have any vaccinations within four weeks prior to the first administration date of the suspect vaccine. Outcome of the events was recovering. Information on the lot/batch number has been requested.

2/22/2021 10:09 pm resident reported 1 episode of being nauseous and having dry heaves, no temperature, MD notified and nurse was told to continue to monitor, no new orders, daughter made aware. Vital signs being done every 4 hours. 2/23/2021 3:04am resident complains of nausea, scant BM amount x 2, MD notified and no new orders, continue to monitor and encourage fluids, vital signs continue every 4 hours.

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.

bowel strain; Sunday I went often, but I had to force myself. It hurts to go, it is really hard to go. I feel the urge to go, but I cannot (defecate) I am sitting on toilet now, trying to...; I'm so sick; This is a spontaneous report from a contactable consumer or other non hcp. A 95-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly administered in the left arm on 24Jan2021 (Batch/Lot Number: EL9263) as a single dose for an COVID-19 immunization. The patient past medical history included blood pressure and thyroid. The patient stated that she took medication for her blood pressure and she also takes thyroid medication. Concomitant medication included macrogol 3350 (MIRALAX) and loperamide hydrochloride (IMODIUM A-D). After the administration of vaccine, the patient experienced bowel strain in Jan2021. On Sunday, she went often, but she had to force herself hurts to go and hard to go. She felt urge to go, but she cannot (defecate) she was sitting on toilet now, trying to and she was so sick. She was going to the bathroom off and on throughout the day on Sunday. She clarified that on Monday and Tuesday she couldn't go to the bathroom, she states that "little marble would come out, but it would hurt". She explained this issue with her bowels started on Sunday. She didnt know if this could be caused by the vaccine since she is having so many problems with her bowels. She reported that Miralax but she hasn't been taking it since she got the shot. She hasn't taken the Miralax in about 3 or 4 days because she was normal. She took Imodium A-D because she was going so much on Sunday. Then, Monday and Tuesday she started having a hard time using the bathroom. The event outcome was Unknown. No further details were provided or obtained. Follow-up attempts are completed. No further information is expected.

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!

Vomiting; diarrhea; This is a spontaneous report from a Non-contactable consumer (patient). A 95-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 03Mar2021 at 11:00 as 2nd dose, single dose in the right arm for covid-19 immunisation. The patient medical history included glaucoma and had known allergies with Penicillin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on 10Feb2021 at 13:30 as 1st dose, single dose in the right arm for covid-19 immunisation. The patient concomitant medications included Baby aspirin, azopt drops, b complex vitamin, meto. On 03Mar2021, the patient experienced vomiting and diarrhoea. The patient did not received treatment for events. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

6/29/21: 2 days of diffuse generalized abdominal pain, nonbloody diarrhea, increased general malaise and weakness. Patient feels chills but no measured fever at home. 7/1: Temp in ED 38.5. She uses 4L of O2 at night baseline but since her COVID Dx has been using 3L in the day as well. admitted to hospital 7/1/21.

Has underlying dementia and often with difficulty eating. 1 week after immunization she developed a stroke with left sided weakness and difficulty swallowing. Comfort measures instituted. Not sure if this is related to the vaccine, but thought I should report

presented to ED 1/9/21 with abdominal pain, progressive worsening weakness and fatigue and new onset A fib with RVR likely due to hypertensive urgency . Patient progressed clinically with severe hypoxia and transferred to ICU and started on BiPAP; progressive decline with decreased urinary output with uremia likely secondary to sepsis. Concern with patient worsening clinical decline, palliative care had been consulted on end of life care. Patient expired 1/17/21

Patient had nausea and vomiting 4 times on 1/20/21, 2 times on 1/21/21, 1 time on 1/22/21. Patient also experiencing constipation.

Patient began to demonstrate a cough the evening of 1/5/2021, after receiving the COVID-19 vaccine earlier in the afternoon. A rapid COVID-19 test was performed and was positive. She began to demonstrate shortness of breath with exertion on 1/7/21, and lethargy on 1/12/21. Appetite and oral intake began to decline on 1/12/21, and Oxygen saturation dropped on 1/16/21 to 82%, and oxygen was initiated at 3L per nasal cannula. On 1/19/21 at 0414 patient was unresponsive and without vital signs. Orders were for DNR, and CPR was not initiated.

I woke up in the night with severe indigestion, a pain in my left jaw and pain in the back of my ribs near my heart. It?s subsided in about one minute time. This morning I woke up with some right arm pain but it was short-lived too. I have felt fine since...

Gastrointestinal issues; threwup/vomiting; Diarrhea; This is a spontaneous report from a contactable consumer (patient's daughter). A 96-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9264, expiry date unknown) in the hospital via an unspecified route of administration on 28Jan2021 on the left arm at a single dose for COVID-19 immunization. The patient was concomitantly taking hydrochlorothiazide (manufacturer unknown) for blood pressure. It was reported that the patient seemed to be okay after receiving the first vaccination when they came home that day but today, Saturday, 30Jan2021, 2 days later, she has had some gastrointestinal issues, she threw up this morning in her bed and now she has a case of diarrhea. The patient doesn't seem to have any fever, she is cool. She doesn't seem to have any respiratory problems but mostly this is gastrointestinal problems. The patient is alert but she had a bout of vomiting and diarrhea on 30Jan2021. The reporter was wondering if the agent had any thoughts about whether or not this was the reaction to the vaccine or something else. The patient did not receive treatment for the events. The outcome of the events was unknown.

Excerpt taken from patient's medical record notes. Recreational Therapist was in room with patient who was at baseline mentation at that time, and was getting patient a cup of tea. Rec Therapist observed patient to "all of a sudden slouch down toward left side" and became unresponsive. Therapist called for help, and Registered Nurse (RN) and Certified Nurse Aide (CNA) came into room. Patient was initially non-responsive and profusely sweating and hot to touch. Vitals were taken (see below). The patient then slowly became responsive after approximately 4 minutes and was visibly nauseous and appeared like she was going to vomit, but ultimately did not. Patient was assisted into bed, APRN was called, order for vital signs to be taken every 4 hours for 72 hours, and Electrocardiogram (EKG) to be performed. EKG results were abnormal, indicative of infarct; APRN ordered transport to Emergency Department. Patient returned from Hospital ED at approximately 10:45 PM same day (1/28/21), with transfer paperwork documenting a Hospital diagnosis of "Syncope" without any additional lab results or any new medication or treatment orders in the documentation. Follow up the next day (1/29/21) by RN at the Nursing Facility--RN logged into the Hospital medical Charting system, only to find that there was no record whatsoever of the patient being in the Emergency Department on 1/28/21--no notes, no labs, no summary from a practitioner. Patient recovered and has resumed close-to-baseline activity and functioning.

There were no symptoms experienced on the first vaccination given on 1/14/2021. The second vaccination was given on 2/4/2021, the following day (2/5/2021) patient complained of fatigue and nauseau. In the evening she went into cardiac arrest and died.

Patient contracted COVID-19 after receiving two doses of Pfizer vaccine. Date of admission approximately 10 week post vaccination. Dates of vaccination unable to be verified as City Immunization Record unable to match with patient. Patient was vaccinated at the a facility. Patient was admitted on 3/31/2021 with ~ 4 days of cough and decreased appetite, found to be COVID positive with pneumonia. Patient received supplemental oxygen, decadron and completed a course of remdesivir. She has improved clinically and was discharged on room air.

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...........

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

feeling cold; stomach pains; coldness was in hands and feet; headache; This is a spontaneous report from a contactable consumer (patient's daughter). A 96-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number: EW0164 and Expiration Date was not reported), via an unspecified route of administration in Arm on 16Apr2021, as 1st dose, single dose for COVID-19 immunization. Medical history included hypertension from Oct2009 and ongoing, cardiac disorder from Oct2009 to an unknown date, myocardial infarction from an unknown date and unknown if ongoing, stent placement from an unknown date and unknown if ongoing. Concomitant medication(s) included apixaban (ELIQUIS); metoprolol (METOPROLOL); simvastatin (SIMVASTATIN); isosorbide (ISOSORBIDE); acetylsalicylic acid (ASPIRINE) all taken for an unspecified indication from an unspecified start date and ongoing. It was reported that within the week prior (Prior to death), she complained of being cold, and had stomach pain, coldness was in hands and feet, she also mentioned headache. The outcome of the events was unknow. Follow up needed, further information has been requested.

Systemic: Cardiac Disorder (diagnosed by MD), Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Fainting-Severe, Systemic: hyporthyroidism vitmain d defiency; symptoms lasted 1 day

Already reported immediate severe weakness, lethargy, withdrawal, delirium. Now adding 4 days later ... hypotension, nausea, vomiting, diarrhea, cramps, chest pain. ER visit and 2 day hospitalization. Abdominal CT indicated intestinal inflammation in the area of the Cecum. One week of antibiotics.

nausea; This is a spontaneous report from a contactable consumer (patient). A 97-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, 07Jan2021 at a single dose for COVID-19 immunization Medical history included cardiac failure congestive. The patient's concomitant medications were not reported. Patient was not pregnant at time of vaccination. The patient previously took quinine and experienced allergy. The patient experienced nausea starting approximately 1 week after shot on 15Jan2021 and continuing for 5 days. Outcome of the event was recovering. No treatment was received. The event was considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination. Information on the lot/batch number has been requested.

Felling ill immediately- diarrhea & loose stool for a few days, headache for a few days, muscle aches- pain in back & side (new), low grade fever daily since vaccine

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

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

prickly feelings; slept all day; felt it right to her stomach; chills; bad anxiety attack; This is a spontaneous report received from a contactable consumer (reporting on herself). A 97-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: HT6955 and Expiration date was not reported), via an unspecified route of administration in Arm Right on 20Mar2021 11:30 (at the age of 97 years-old) as SINGLE DOSE for covid-19 immunization. Medical history included cardiac murmur, chronic kidney disease, hypertension, blood pressure measurement all from an unknown date and unknown if ongoing. Concomitant medication(s) included atenolol (ATENOLOL) taken for blood pressure measurement from an unspecified start date and ongoing; nifedipine (NIFEDIPINE) taken for blood pressure measurement from an unspecified start date and ongoing; losartan (LOSARTAN) taken for blood pressure measurement from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for water pill from an unspecified start date and ongoing; potassium (POTASSIUM) taken for take with the water pill from an unspecified start date and ongoing. It was reported that she got the first shot week ago; clarifies she received the first dose of the Pfizer COVID-19 vaccine on 20Mar2021 at 11:30 in the right arm. States when she got the injection she felt it right to her stomach. The next day she had chills. Patient mentions one night she woke up with a bad anxiety attack in the night, she felt another tiny anxiety attack again yesterday but she told herself you are okay. One day last week she slept all day; and then there was one night were she was just sitting there and she felt prickly feelings all over. Now she was concerned about getting the second shot and was asking how strong was that second shot with regard to her side effects. She called in before to Pfizer the second week to ask about her side effects and left a message for them to call back but no one ever called back. No reference number provided. This will be a follow up. She was planning to receive the second dose on 10Apr2021. Tests: Mentions she recently had an echocardiogram and an EKG but no results are provided. No follow-up attempts are needed. No further information is expected.

PMH Afib, BiV PPM, HTN, pHTN, hypothyroidism, hemorrhoids, hearing loss, macular degeneration, squamous cell carcinoma, Parkinsons brought to ED after her caregiver found her in bed in AM w/a "dark substance in her bed" and minimally responsive. On admission vomiting x1, no cough, no SOB, abnormal CXR, covid+ Admission originally planned by IMS, but CCM asked to take over due to rapid decline.Pt w/ shallow breathing, guarded prognosis.In the morning on May 1, 2021 around 830 in the morning patient found to be without any pulse or breathing. DNR DNI with pupils fixed and dilated without any spontaneous breathing. No pulse palpated.pronounced dead at 8:30 a.m.

Pfizer COVID19 Vaccine EUA Hospitalized after presenting with dark brown emesis and abdominal pain-> small bowel obstruction.

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

Stomach ache; Restless; Couldn't sleep; Headache; So hot she couldn't keep cool; This is a spontaneous report from a contactable consumer (patient). A 98-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL8982, expiration date not reported) via an unspecified route of administration at the left arm on 12Jan2021 15:45 at a single dose for COVID-19 immunization. The patient's medical history included arthritis, she is in a wheelchair (can't walk), gallbladder out a year ago (2020) and she her right hip replaced. No family medical history. There were no concomitant medications. The patient usually sleeps well. Clarified she received the first dose of the Pfizer COVID 19 vaccine 12Jan2021 15:45PM in the left arm. She was fine after the injection then 13Jan2021 in the afternoon she had a headache for two hours; that night she was restless and couldn't sleep; she was so hot she couldn't keep cool. Then this morning 14Jan2021 her headache is gone but she has a little stomach ache. Mentioned they haven't brought breakfast by yet and that might help. She was planning to get the next dose of the vaccine 02Feb2021. She has been living in an assisted living facility now for three years; and she can't get outside; and has not seen her family due to the virus. The facility where the vaccine was administered was in an assisted living facility. There were no additional vaccines administered on same date of Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events did not require a visit to physician or ER. No relevant tests done. Outcome of the events headache, feeling hot, restless was recovered on 14Jan2021; stomach ache was recovering and unknown for the other event.

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.

I am the discharging physician and did not admit her but based off the information at admit: the patient received her Pfizer vaccine and developed nausea during her observation time but it was not significant enough to cause concern for the family. They took her home in good spirits and she appeared to be doing well until the evening when she became unresponsive. She developed high fevers and came to the ER with low normal O2 saturations and evidence of sepsis. Blood work showed a markedly elevated white count and an elevated lactic acid of 8 along with an elevated renal function and cardiac enzymes without EKG changes (multiorgan failure). Her COVID test was negative. Blood and urine cultures were negative. A CT scan of the abdomen demonstrated no acute findings but likely chronic fecal impaction. CT Head was negative for bleed or stroke. At this time is is unclear as to what was the cause of her symptoms but we believe it was presumed bacterial sepsis but this diagnosis is in question as all her cultures were unremarkable. The family opted on comfort measures rather than aggressive intervention and she was sent home with hospice. Since it occurred so closely after receiving the vaccine I think it was worthwhile to bring it to your attention.

Minor arm pain on 2nd day of each vaccine Diarrhea 3 days after 2nd vaccine Massive heart attack (left ventricle) 8 days (2/24/21) after vaccine Home hospice 3:30pm 2/24/21 Stopped breathing 5:45 am, pronounced dead at 8:22 am on 2/25/21

Pt had worsening altered mental status, tachypnea, and low-grade fever on 1/13/21. Pt considered terminal status previously and comfort-focus care pursued. Suspected pneumonia vs. TIA/CVA. PO meds D/C'ed as patient could no longer swallow.

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.

presented to the ED with substernal chest pain with right to left side radiation and continuous waxing and waning right sided abdominal pain with back radiation consistent with previous episode of acute cholecystitis; still admitted

Received first dose of Pfizer vaccine in left deltoid on 4/8/21 at 7:30 am. At 10:00 am, she called her niece and complained of extreme fatigue. At 12:00 pm, she complained of worsening fatigue and blurry vision. At 3:40 pm, she complained of loss of appetite but denied fever and chills. The niece was unable to reach her by phone after 4 pm, so she came over to the decedent?s residence at 6:15 pm to check on her. The niece found her lying face up in bed ?gasping for air.? She then became unresponsive and EMS was called. The decedent was pronounced at 8:11 pm after unsuccessful resuscitative efforts. Autopsy showed hypertensive and atherosclerotic cardiovascular disease with marked partially calcific coronary atherosclerosis; marked pulmonary edema; and pleural effusions. The brain was saved for neuropathology given the history of blurry vision.

Acute appendicticis and rupture folloiwng vaccination in a senior with no previous surgeries, comorbidities other than high blood pressure, and no previous vaccine reaction. Appendix ruptures, emergency surgery was agreed upon and this woman is recovering 14 days later at home.

Pt. developed emesis, vomiting blood afternoon after covid vaccine. She died within a few minutes. Resuscitation not attempted due to DNR status. Had recovered from covid months before.

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.

vaccine appt 11:30 am vaccine administered 11:42 am observation 15 minutes left facility 11:57 am fine for 36 hours except pain in left arm onset of vomiting, severe stomach pain and ultimately several BMs sweats and weakness Primary Dr was called finally about 12:30 all symptoms subsided lingering abdominal pain used heating pad slept off and on in night but no further events no events today 2/14/21 other than weakness, fatigue and arm pain - light diet and hydration Dr suggested ER - didn?t want to go

Patient, age 101, was having a period of declining health prior to vaccine administration. This continued after the vaccine to include increased pain, inability to swallow and ultimately Patient passed away on 1/9/2021. The physician does not believe this is due to vaccine administration, however family asked that this information be reported for record keeping.

Dose given at 1649hrs. At 2030hrs, complaints of headache and diarrhea. At 0100hrs on 03/21, family noticed patient unresponsive and not breathing. Fire rescue called out and pronounced her at 0210hrs.

Patient received vaccine at 1344.. Upon the end of observation time at 1400 patient's caretakers began to wheel the patient out. Patient's caretakers did not check in with the medical team. When they discovered she was unresponsive in wheelchair in hallway of facility they alerted the medical team. Several staff members (RN's, ER MD) at patient's side obtaining VS, changing out pts home O2 NC to a NRB mask. Patient appeared to have vomited on self before medical team arrival. Vitals taken at 14:05 BP 127/106, HR 64, SP02 89%. Emergency department team arrived. Patient transferred to gurney and taken to emergency department for treatment.