Pfizer

Lowered body temperature 30 min after dose, left hand began to itch approx. 45 minutes, both hands itching & swelling, then feet within hour. Total lose of vision within 90 min followed by fainting approx 10 minutes later. Fainted at check-in desk of emergency room

Within minutes I felt dizzy and then my heart started beating rapidly. Nurse took my blood pressure, pulse, respirations. I was held at clinic for 30 minutes. Symptoms subsided gradually and were gone in 15 minutes.

fever up to 103, chills, aches, malaise, abd pain, vomiting, went to the ER had IVF abnormal labs, + non st elevation MI

decedent had shortness of breath and hypoxia, cardiac arrested in front of the EMS crew, ACLS initiated, arrived in the Hospital ED asystole and pronounced dead

Patient with known CAD. Per member, has had NTG 5x in last 6 months. Patient states unable to do anything but medical therapy " all 6 grafts clogged". c/o precordial and right sided chest pressure, took ntg with improvement , recurrent pain and member took second dose of ntg .Pain started to return and 911 called.

Patient described fast heart rate and irregular. Stated she gets it with all allergies and frequently Given requested benadryl 25 mg po with resolution of symptoms

Within 5 minutes I became nauseated, then l began growing weak, alerted staff and they started monitoring my blood pressure which had gone up to 159 (usual is around 120), began uncontrollable shaking. After about 1 1/2 hours my blood pressure lowered to 136 and I was transported by wheel chair to car to return home.

believed the heart rate might be a result of being nervous; Tightness of throat/throat tightness; Laboured breathing; Fast HR/high heart rate; This is a spontaneous report from a contactable nurse, reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 03Jan2021 at a single dose for COVID-19 immunization. Medical history included sensitivity to pollen, sensitivity to narcotics and allergic reactions to perfume, all from unknown dates and unknown if ongoing. There were no concomitant medications. The patient previously received pneumonia vaccine and flu vaccine, both for immunization and experienced pain on the side. The patient also previously took cortisone to lower her immune system. It was reported that on 03Jan2021, the patient developed a slight reaction immediately after first dose of Pfizer Covid vaccine which included tightness of throat along with laboured breathing with fast HR/heart rate was high (she believed it was greater than 80 BPM; her heart rate is usually in the 60's) which resolved after a few minutes. The nurse was going to give her Benadryl but did not as her signs and symptoms were resolving. She was asking for recommendations/clarifications on whether she should get the second dose given her reactions. She never had that type of reaction before. She had had sensitivity to pollen and narcotics. She read that she should not receive the second dose given her reactions but was asking for clarification. She would like to get the second dose and bought an Epi pen. Throat tightness and high heart rate didn't last for more than two minutes maximum. She visited websites and was directed not to get the second dose. She wanted to be 100% certain in regards to whether or not she should receive the second dose. Stated tightness in throat wasn't really that bad. She felt throat tightness previously when smelling perfume. Stated it wasn't anything to be frightened about. She also stated some websites said it does not matter and some websites said not to get the second dose. Also wanted to know if having the Epi Pen would help. She added that she explained reaction to the physician who advised her to get an Epi Pen for the second COVID Vaccine dose. She only had allergic reactions to pollen and perfume. Got the vaccine for Pneumonia and Flu. Did not get adverse reactions, but stated she only had pain on the side. Confirmed she has no NDC/Lot/Exp for the Pneumonia vaccine and Flu vaccine. She also got Coronavirus three months prior to receiving the COVID vaccine. She clarified that she diagnosed herself and it was the weirdest thing. She took cortisone to lower her immune system. Received first dose of COVID Vaccine on 03Jan2021. She wa due for second COVID Vaccine on 26Jan2021. She stated she is a psychologist with specialty in mental health. She believed the heart rate might be a result of being nervous. When she is nervous her heart rate goes up. Tightness of throat made her concerned. When asked about the indication, she stated that her husband works and the right thing to do was to be protected. She read she should have stopped taking Ibuprofen 10 days prior to the COVID Vaccine. She was not taking Ibuprofen any longer. Has no NDC/Lot/Exp for Ibuprofen at time of call. Confirmed she did not use the Epi Pen after the first dose of COVID Vaccine. She bought it for the second dose. The nurse who administered COVID Vaccine to the patient suggested she take Benadryl. By that time, she was feeling better. She stated it was questionable for half an hour. The outcome of the event Tightness of throat/throat tightness and fast HR/high heart rate was recovered on 03Jan2021 while the outcome of all other events was unknown. Information on the batch/lot number has been requested.; Sender's Comments: The patient had medical history included sensitivity to pollen, sensitivity to narcotics and allergic reactions to perfume. The reported events were likely related to first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to plausible temporal relationship and clinical course. 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.

Rapid heart beat, went from normal 60 BPM to 110 up to 135 BPM went to ER as instructed in handout sheet

AFib / rapid heartbeat an hour after receiving first dose. AFib again two days later around 11a on 1/30. Lasts for about 45 minutes

Patient experienced chest heaviness and warmth from her chest to her arm. Her blood pressure was 220/120s. We monitored her and her blood pressure decreased to 170s/110s over 30 minutes. EMS was called to evaluate her but she refused to go to the hospital.

Chest tightness; hives on the side of her neck; scratchiness in throat; gums were throbbing; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EJ1686, Expire Date: 30Mar2021), intramuscular at Deltoid Left on 15Jan2021 11:08 at the 76 years old at 0.3 mL, single for COVID-19 immunization. The patient medical history included allergies issues with shellfish (allergic reactions), hyperlipidemia and hypertension. The concomitant medications were none. There was no additional vaccines administered on same date of the suspect. The patient was experienced for over 20 minutes with no side effects. After she left on an hour after administration (15Jan2021 12:08), she started feeling scratchiness in throat, her gums were throbbing and chest tightness. She did say she didn't take any Benadryl. She didn't have airway issues, but she did have hives on the side of her neck on 15Jan2021 12:08. She got the shot on 15Jan2021. The side effects started shortly after she left on an hour after administration. Her symptoms were relieved by 15Jan2021 21:30, and she got the shot at 11:08 am. The patient had allergic reactions in the past. She knew what to expect. She got the shot in her Left Deltoid. The reporter had a gut feeling she didn't need to get the second dose. The reporter assessed all the events were not serious. She did not require medical intervention. She did not go to the Emergency room or Physician Office. The patient was not hospitalized, or in the ICU. The Causality was not provided by the reporter. The outcome of the events was recovered on 15Jan2021 21:30.

Patient was observed for 15 minutes after the vaccination administration, felt fine, and left the facility with her husband. The 2 of them drove 2 blocks away to a restaurant to eat. Midway through her meal, she reported that she started to feel "funny" like she was "drunk" or something, and felt nausea and hot/sweaty. Her husband got her in the vehicle and drove to the vaccination facility, When he arrived, she was obtunded and "out of it." No respiratory distress, No noted rash, but some clamminess/diaphoresis. She was initially examined by FNP and cursory limited neuro exam while patient was seated did not reveal any gross motor deficits. FNP called 911 and staff called for me. When I arrived, patient was groggy, but responsive. She was A&O x3 and in no distress. Pulse 54, strong and regular (normal rate for her per patient--on a Beta blocker). BP 120/74. O2 sat 97% on outdoor cold air. Patient was able to move all extremities equally and with equal strength. Lungs CTA, Heart regular no murmur, abdomen soft. Patient complained of continued malaise/grogginess and nausea, no vomiting. EMS arrived, checked glucose, which was "normal" (I didn't hear the result) and patient declined transport. I discussed ER evaluation vs. continued monitoring by me. Patient and husband requested monitoring. Patient stayed in the vehicle with her husband, I gave the husband my phone number to call if any worsening. I checked on her 5 minutes later, then 10 minutes after that. By that time, her adult daughter had arrived. We again discussed continue family monitoring vs. ER. The family wanted to take the patient home to monitor. Patient stated "If I could just go to bed, I think I will be fine." I called to check on the patient at 6p. She had rested well and was improved. She still felt a bit groggy, but otherwise was feeling better. I called to check on the patient 1/29 at noon. At that point, husband stated that she was "back to normal. Symptoms and signs appeared to be consistent with a vasovagal response. I suspected symptoms may have been prolonged by her Beta blocker

24 hours after receiving the vaccine, I passed out while walking. I do not have any other new medications; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Arm Left on 13Jan2021 at 08:00 AM as a single dose for COVID-19 immunisation, lot number: EL3249. Medical history included bronchiectasis. Patient had no known allergies. Concomitant medications in two weeks prior to the vaccination included olodaterol hydrochloride, tiotropium bromide monohydrate (STIOLTO RESPIMAT), salbutamol (ALBUTEROL HFA) and multi vitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jan2021 at 10:00 AM patient passed out while walking, 24 hours after receiving the vaccine, patient did not have any other new medications. Event resulted in emergency room/department or urgent care and hospitalization for one day. Treatments received included cast on hand, computerised tomogram (Ct) scans, electrocardiogram (EKG) and echocardiogram on unknown date with unknown results. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination patient had not been tested for COVID-19. Patient was recovering from the event, at the time of the report.

76 yo female with PMHx of CAD s/p CABG 2016, abdominal aortic aneurym, HTN, HLD, Asthma, Diverticulosis, Osteopenia. Presenting to the ED after having Pre-syncope. She reported that today morning she felt nauseated with episode of vomiting, burping and abdominal discomfort after having her lunch meal, headed out to receive her vaccine, she felt well till 10 minutes after the vaccine where a nurse noticed she is pale and less responsive, BP was measured back then and was ~70 ?, the patient reported that she was sitting when that happened, she felt lightheaded, sweating, blurry vision, nauseated. But denies any chest pain, sob, palpitation, weakness or numbness. She was out of balance and feeling weak till she came to the ED where she felt better after IV fluids.

Anaphylaxis symptoms started three day after the shot I started having chills, trembles, sore throat, very high BP, Swelling and numbness on tongue and lips, pain and burning of feet, tingling all over, joint pain,

Rapid heartbeat, shaky, clammy skin, heavy perspiration, nausea, stomach cramps, pain throughout body along with pin and needle feeling mostly on the left side from my foot to the top on my head. Lips felt swollen. Itch in chest, neck with a rash, back legs, mostly all over.

Pt developed nausea, dizziness, and chest pain during her 15 min observation period. Pt was clutching her chest and stated that she felt her heart racing. 911 called and pt transported to ED.

Pt received injection, then collapsed, with no memory of event. Pt was unresponsive approximately 15 seconds. HR 52 & irregular, BP 110/80

"Pfizer-Bio-Tech COVID-19 Vaccine EUA" After receiving the Covid-19 vaccine at 12:15 pm client compliant of having tingling lip and tongue symptoms. She stated that she has anxiety and had the same symptoms with the 1st vaccine and received liquid Benadryl. He brought in a note from the allergist that the benefit outweighs the risk and individual should be given vaccine in a controlled environment. 12:15 patient received 25 mg po of Benadryl elixir by mouth 99% Sat's, 156/90,79,20; 12:20 pm v/s 158/92, 56, 20, 99%, 12:25 PM, v/s, 150/90, 56, 18, 99%. Individual was monitor for 30 minutes and stated her can barely felt the tingling in her lips and tongue. Discharge vitals at 12:43 pm 146/92, 58, 18, 98 %.

Pt with acute resp failure, COVID PNA, that developed symptoms 9 days prior to admit and ultimately received first vaccine 6 days prior toa admit, then shortly after progressed with other covid symptoms and was admitted. She decompensated while intp and was transferred to ICU for rising O2 needs, ultimately had to be intubated. Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle. Sx and IR consulted and did beside exploration of hematoma. Initially blood pressure responded but overnight continued with refractory hypotension. Maxed out vasopressin and levophed, hemodynamics deteriorated. Pt passed soon after(2/2).

BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back; Back getting hot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 76-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date not reported) , via an unspecified route of administration on the left arm on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included anaphylaxis with contrast media (Biaxin and eucalyptus), allergies: latex, antihistamines, sulfa, olive trees; allergic reactions to iodine, asthma, cardiac arrest, has a pacemaker; all from unknown dates. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), vitamin D3, levocabastine hydrochloride (ZYRTEC), iron, diltiazem, salbutamol sulfate (ALBUTEROL). The patient previously took Biaxin, eucalyptus and tiger balm and experienced anaphylaxis, Cipro, sucralfate, adrenaline (EPIPEN), corticosteroid and experienced allergies. The patient previously received Shingles vaccine on Nov2020 for immunization and experienced intermittent itchy back sensation. The patient reported that after vaccine reaction today (27Jan2021) - back rash, burning sensation, swollen face. It was further reported that the patient experienced potential anaphylactic reaction; 15 minutes after the administration she got her back getting hot and Itchy and a rash breakout. It was also reported that the patient's BP was a bit high for her on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: a bit high for her on an unspecified date. Therapeutic measures were taken as a result of anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot which included treatment with Benadryl (Took one 25 mg Benadryl. Then she took another 25 mg Benadryl); it was reported that 30 minutes later symptoms started to subside. The patient recovered from anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot on 27Jan2021, while the outcome of BP was a bit high for her was unknown.

Patient received the vaccine at an outside healthcare facility on 2/11/21. At approximately 1 pm she screamed out and fell out of her chair. EMS was called and patient was found to be in Vfib. ACLS was performed for approximately 42 minutes prior to arrival at ED. At that time the patient had been pulseless for 25 minutes. Patient received 450 mg of amiodarone, epinephrine x7, sodium bicarbonate x2, and 7 AED shocks. In the ED 3 more doses of epinephrine were given, one more dose of sodium bicarbonate, and 5 additional shocks. ROSC was not achieved and time of death was called at 1416.

Immediately, within 2 hours of the vaccination, I developed a severe headache, join pain (knees, elbows, mostly legs and lower extremities) which evolved into intense, burning abdominal pain. My blood pressure rose to 160; however, there was no fever, cough or shortness of breath. This condition lasted until the 7am on the morning of February 8th, but pains returned that evening (Monday 2/8) through Tuesday morning. Symptoms subsided during the day on Tuesday, yet on Tuesday evening (2/9, approximately 48 hours after the injection), severe symptoms returned, similar to the initial evening. I visited my Primary Physician on Wednesday afternoon (2/10) for a consult.

She had emesis within 30 minutes of 2nd dose of vaccine. Her nausea continued for 1 hour with abdominal and chest discomfort. She was taken to ED. Her vital signs remained stable. All work-up for cardiac event was negative. This was determined to be a vaccine reaction leading to nausea with 1 episode of emesis.

Started having fever chills nausea and diarrhea and felt short of breath on 2/13. SOB and diarrhea was better on 2/14 bug then on 2/15 pt started to feel chest pressure. pt admitted to hospital on 2/15 noted to have NSTEMI and plt=68. Thrombocytopenia is new for pt. on 2/16 plt=79. pt has been on ibrance for years for hx of breast ca- has never had thrombocytopenia related to the ibrance.

Within 15-minutes of vaccination, the patient reported dizziness, lightheadedness, and nausea. EMS evaluated patient on-site and administered 4mg Ondansetron PO. Patient was hypertensive (156/84) in transport to Emergency Department. Patient remained hypertensive in ED. Discharged from ED with diagnoses of dizziness, nausea, resolved, secondary to vaccination.

Pt passed soon after; shortly after progressed with other covid symptoms and was admitted / acute resp failure, COVID pneumonia; acute resp failure, COVID pneumonia; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle.; This is a spontaneous report from a non-contactable Pharmacist. A 76-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE lot number EL3247), intramuscular on 19Jan2021 at single dose for COVID-19 immunisation. The patient medical history included COVID symptoms from 16Jan2021 and ongoing. Concomitant medications were not reported. The patient with acute resp failure, COVID pneumonia, that developed symptoms 9 days prior to admit and ultimately received first vaccine 6 days prior to a admit, then shortly after progressed with other covid symptoms and was admitted on 25Jan2021. She decompensated while intp and was transferred to ICU for rising O2 needs, ultimately had to be intubated. Became hypotensive due to massive hamatoma 2' bleeding into abd rectus muscle. Sx and IR consulted and did beside exploration of hematoma. Initially blood pressure responded but overnight continued with refractory hypotension. Maxed out vasopressin and levophed, hemodynamics deteriorated. The patient died on 02Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events death, COVID-19 pneumonia, acute respiratory failure, hypotension, abdominal wall haematoma and abdominal wall haemorrhage cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. 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.; Reported Cause(s) of Death: Pt passed soon after

The first night after the vaccine had a headache and woke up with pain near her mouth. The 2nd night, Tuesday, 2/16/21 it got bad, woke up around the same time early morning, had pain on the right quadrant of her upper body, from her ear, eye, throat and down to right under her throat. When she swallows the pain is very severe with difficulty swallowing and that pain radiates to the upper part of her chest. Then on the third night, last night, all the same pain but the headache had disappeared. Today, 2/18/21 she is still having the same symptoms. The hardest thing to deal with is the ear pain in the right ear, and the pain under her right throat area. She has taken one Benadryl at 8:00 AM, and will take another at 8:00 PM. The Benadryl triggers her tinnitus so is limited with that. Her daughter is trying to find OTC medicine for the ear. She has not called her doctor as they are trying to treat it with OTC medicines. For additional information call her daughter: who takes care of all her medical information.

After receiving the vaccine, my daughter took me to my Cardiologist appointment (this was scheduled before I received the vaccine). When I got to my doctor my blood pressure was elevated, it was about 180/88. My blood pressure is never that high. It did go down before I left to 140/84. When we were walking in the elevator after leaving the appointment my gait was unsteady. I felt very weak. I also light headed, and dizzy. It felt like the feeling of the sedation you have receive before having surgery. When we made it home I couldn't even see straight. This lasted about 2 hours. I feel much better today.

Patient on 02/09/21 starting having slow thought process and weakness in left arm and hand and had little strength in left hand and was dropping things. patient was scheduled for ct scan for headaches later that week. Called and got ct scan to be done state. Patient had a CT scan on 02/09/21 which was negative and saw the doctor on 02/12/21 and he ordered an MRI which showed patient had a CVA, cerebrovascular accident-stroke, MRI results revealed the CVA.

CLIENT STATES 9:15AM ON 2-5-21 SHE WAS PASSENGER IN CAR AND HUSBAND NOTICED THAT SHE HAD STOPPED TALKING AND WAS JUST STARRING X 2 MIN, THEN BECAME RESPONSIVE AND TALKATIVE AGAIN. SHE WAS 'NOT QUITE HERSELF FOR ABOUT 3 DAYS'. MRI, MRA, CT OF BRAIN & U.S. OF CAROTIDS DONE. DX WITH RT TEMPORAL/PARIETAL CVA. NOW ON PLAVIX & ASA 81MG. HAS APPT WITH NEUROLOGIST 2-17-21. REMAINS 'NOT QUITE HERSELF AND OFF BALANCE'.

I received my 2nd vaccine at 12:15 at the facility on Tuesday, Feb. 16. At about 10:30 that night I began to feel a bit light headed. I went to bed around 11:30 and didn't sleep very well. On Wed. am after going to the bathroom, I felt woozy while washing my hands. When I thought I felt better, I made my way back to the bedroom and passed out. I fell on my right side, bruising the right side of my face, my right hip and my right thigh. I apparently had my left hand under me when I fell because I broke the knuckle under the pinkie of my left hand.

Patient received 2 doses of COVID-19 vaccination in same arm on same day (several minutes apart). No symptoms reported, aside from anxiety-induced blood pressure elevation

post injection, c/o pain and tingling bilateral arms, chest tightness, and tongue "feels strange", difficulty breathing

passed out / fell; passed out / fell; developed a nose bleed that would not stop; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. Medical history included high blood pressure, diabetic, stage 3 kidney disease, known allergies to penicillin. The patient's concomitant medications were not reported. It was reported that patient got the shot on Thursday morning (04Feb2021) and later that evening reported as at 10:00pm, the patient developed a nose bleed that would not stop. By 10:30pm she passed out/fell, site car management was called and she was sent to the ER where she stayed for evaluations for 2 days. The reporter does not think the Covid shot was connected to the event. No treatment was given to the patient. The patient had no covid prior to vaccination and was not tested for covid post vaccination. The patient was recovering from the events at the time of the report. Information about lot/batch number has been requested.

Day after vaccine she felt tired, today she woke up coughed up blood then noticed that her nose was bleeding; bleeding lasted about 1.5 hours, now stopped #1 Pfizer 1/31/21 1115 #2 Pfizer 2/20/21 1300 #1 Pfizer lot EL9265 #2 Pfizer lot EN6200

fast heartbeat, first experienced 2or 3days after injection, during early morning hours, 2 nights then the next night no fast heartbeat, the fourth night again the fast heartbeat two times during the same night. I originally thought it was possibly what I had eaten, or maybe my medication. After reading side effects of vaccine I decided to report this thinking it could possibly be the vaccine.

Patient complained of racing pulse, anxiety, dizziness during 15 min observation time. BP elevated 175/91, HR 120-130. pOx 99% RA. talked patient through deep breathing, anxiety reducing exercises. Vitals started to come down (153/71, HR 96). Patient then complained that she was feeling unwell again, very dizzy, HR increased as well as BP again. 911 called to patient to go to ER for evaluation.

Patient developed extensive superficial thrombophlebitis of left leg within 36 hours of receiving the vaccine with no other provocative factor

Patient presented with tightness in chest. HR 70 sinus rhythm BP 171/81 and then 171/89 She refused transport to hospital.

Received the vaccine & the next day became very weak and ill with throwing up. Her sister came to visit and noticed her right face was drooping & her balance was off so she called ambulance. Subsequently has been hospitalized for a month with a heart failure exacerbation that has led to ICU care, sepsis with Klebsiella pneumonia, acute kidney injury now with long term dialysis, hyponatremia, & elevated liver enzymes

Patient began feeling tired 1 hour post dose. At 3 hours post dose, patient began feeling woozy, dizzy and disoriented. Patient got dizzy and passed out while walking to bathroom. She fell and sustained a significant laceration to her arm. She continued to feel dizzy and "just not right" several times over the hour until she finally called 911. When paramedics arrived, she continued to lose consciousness and required full assistance to be placed onto the stretcher. Her BP was all over the place for the better part of 6 hours, with highs as high as 145/95 and lows as low as 81/42. This reaction lasted for a total of 8 hours.

. Following Covid-19 vaccine, patient complained of rapid heart rate @ 16:15. Vital signs were taken at 16:16: o2 Sat: 99%, Pulse: 76, BP: 200/99. Patient stated that she did not drink enough because she had a long commute home, and did not want to use the bathroom. RN recommended the patient to drink water, and handed her a bottle of water, which she drank completely. Vital signs were retaken at 16:21: o2 Sat: 100%, HR: 70, BP: 192/91. Patient was advised that she will be taken to the ER for continuous monitoring, but the patient insisted to decline, and stated that she did not want to go to the ER.

rapid heartbeat/went up, the highest was 135/went to 110, 96, 105; This is a spontaneous report from a contactable consumer (patient) reported that a 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on the left arm on 27Jan2021 13:30 at a single dose to protect against Covid. The patient's medical history was not reported. Concomitant medication included as heart medication (unspecified). The patient previously received FLU VACCINE on an unspecified date for immunization. The patient reported that she had the first Pfizer Covid-19 shot last Wednesday (27Jan2021) and got an adverse event, rapid heartbeat. She ended up going to the emergency room and had an EKG, chest x-ray, and bloodwork (complete blood work) to see for heart problems, they checked her heart. Normally her heart rate was about 50-60, but hers went up, the highest was 135. She was monitored, and her heart rate went to 110, 96, 105, and it kept going up and down and then she was later released. It didn't actually go back down to normal until about 8:30-8:45 that night as mentioned once the heart rate went down that night, it's been normal since then. The outcome of the event was recovered on 27Jan2021. She wanted to know if she should get the second one. She was to get the second dose on 17Feb2021 and not sure if she should get it or not, wanted to know what Pfizer recommends.

Patient was admitted with impression of COPD exacerbation and hypoxia. She was treated with antibiotic and bronchodilators. Her symptoms gradually improved and she was discharged. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

shortness of breath, dyspnea on exertion that started after 2nd vaccine, found to have pulmonary embolism 2 weeks later

Reported not feeling well, sent to ED. Per Ed note: Patient here from covid vaccine clinic. c/o throat tightness w/ small amount of dyspnea. states throat feeling better now, still having some tightness in chest. Patient received IV benadryl and IV famotidine and felt fine. No need for treatment with epinephrine IM. Was discharged home.

Pfizer-BioNTech COVID-19 Vaccine EUA Patient had just received her 1st COVID vaccine and was sitting down monitoring symptoms when she suddenly flipped into a different heart rhythm and felt palpitations like her heart was racing. Her heart rate was checked and found to be 130 beats per minute. Transferred to the emergency department On arrival to ED, patient is well-appearing in no distress. Heart rate 134 on arrival. EKG performed and confirmed atrial fibrillation. IV was established, fluids and additional IV metoprolol administered. Labs with mild hypokalemia at 3.2 which was replenished in the ED. Heart rate flipped to normal sinus rhythm and repeat EKG showed her baseline right bundle-branch block with left axis deviation, T-wave inversions in lead V2, V3, III consistent with previous EKGs. She reports she has improved symptoms, no increased dyspnea and no chest pain. Patient discharged home

SOB a few days after vaccination; one week later, new onset of acute exacerbation of HFrEF with subsequent respiratory failure and hospitalization

Within 15-minutes of vaccination, the patient reported dizziness, nausea, and chest pain. EMS evaluated the patient on-site. Patient was found to have orthostatic hypotension, hypoglycemia, and was near-syncopal. EMS administered 400mL of normal saline and 15g oral glucose. EMS transported the patient to Emergency Department. In the ED, the patient was hypertensive (163/73). EKG demonstrated NSR, rate 67 bpm, no ST-T changes, no ectopy, normal PR & QRS intervals. CBC/CMP was unremarkable. Patient noted improvement and was discharged with a diagnosis of a probable vasovagal event.

Lost consciousness; palms began to itch, then soles of feet; This is a spontaneous report from a consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (lot number was EL8982 and expiration date was unknown) via an unspecified route of administration at left arm 18Jan2021 14:30 at single dose for COVID-19 immunisation, amoxicillin via an unspecified route of administration from 18Jan2021 at 14:50 at 4 DF for dental apt, procaine hydrochloride (NOVOCAIN) via an unspecified route of administration from 18Jan2021 at unknown dosing regimen for an unspecified indication. Medical history included 3 joint replacements and known allergies to raw celery, clover honey and ragweed. Concomitant medication included atorvastatin calcium (ATORVASTIN), brimonidine tartrate, timolol maleate (COMBIGAN), levothyroxine, tolterodine. There was no other vaccine in four weeks. Patient did not have COVID prior vaccination. The patient had no reaction in first 15 minutes. Within 20 minutes of shot, patient took 4 amoxicillin for dental apt (as reported), then received procaine hydrochloride (Novocain). 45 min after shot, her palms began to itch, then soles of feet. Then she total loss of sight on 18Jan2021 at 15:30. Patient lost consciousness at emergency room check-in. Patient visited emergency room/department or urgent care. Patient received epinephrine injection as treatment. She also had CT scan of head and chest in Jan2021. She did not have COVID tested post vaccination. The outcome of events was recovered in 2021. The action taken in response to the events for amoxicillin and procaine hydrochloride was unknown.

Developed N/V ~2 weeks after 2nd covid vaccine. Presented to PCP, labwork revealed AKI and hyperkalemia. Sent to ED. Admission lab included SCr 8.55 mg/dL and K+ 5.7 mmol/L. Repeat K+ level 7.0 mmol/L (6 hours later). Pt admitted, vascath placed, emergently dialyzed. Further work up revealed positive anti-nuclear antibody, positive anti-nuclear antibody titer, and elevated glomerular basement membrane antibody. High dose steroids (methylprednisone 1g iv qday x 3 days) started for presumed vasculitis. Renal biopsy performed, results c/w severe crescentic acute glomerulonephritis. Treated with rituximab 375mg/m2, subsequently transferred to another facility for plamapheresis.

Patient complained of "Whooshing" in her ears and nervousness. Blood pressure taken. BP elevated. Patient's husband states that this "whooshing" has been going on for about a year. No trouble breathing, no itching, no rash, no swelling of mouth our throat. Patient advised to consult a physician related to elevated blood pressure. Patient declined EMS.

Pain, headache, tiredness, loss of appetite for the 2 days after the injection (February 20th and 21st. ON THE 22nd I WOKE UP TO A SEVERE NOSE BLEED THAT I COULD NOT STOP! I NEVER RECALL HAVING A NOSE BLEED IN MY LIFE! I HAD MY SECOND SHOT ON FRIDAY, MARCH 12, AND WHILE SITTING WATCHING TV MY NOSE STARTED BLEEDING AGAIN EXCEPT, NOT SO PROFUSELY! It seem very strange to me that this would happen days after having the Covid vaccine

Headache first and 2nd day. A week later woke me up 2 nights in a row but only lasted 12-15 minutes. Skipped heart beats day after and the next am, none since. Rash of red irregular dots about the size of a pencil eraser with bumpy raised flesh directly on veins. started 2 weeks after, lasted 4 days, loss of appetite, much more intense joint pain and sleeplessness which comes and goes.

stroke; Extensive FLAIR hyperintense signal signal in the cerebral white matter/ Mild hyperintense signal in the brain stem and medial cerebellum; This is a spontaneous report from a contactable consumer. This consumer reported for a 76-year-old female patient (reporter's mother) who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3302) first dose via unspecified route of administration on 21Jan2021 at 12:00 PM in left arm at single dose for COVID-19 Immunization in the hospital. There was no other vaccine administered in four weeks. Medical history included COPD (Chronic obstructive pulmonary disease), Small Cell Lung Carcinoma with metastases to brain s/p surgery, chemotherapy and radiation in 2014, dementia. Concomitant medications included citalopram at 40mg, levothyroxine at 0.05 mg, salbutamol (ALBUTEROL). The patient previously took Codeine and experienced allergies. The patient was not pregnant at the time of vaccination. The patient did not have COVID prior to vaccination. The patient had what appeared to be a stroke on Saturday, 23Jan2021 at 12:00 PM. A CT, MRI and an Echocardiogram were all performed on 23Jan2021 and there was no acute intracranial hemorrhage, mass effect, midline shift, or extra-axial fluid collection. Extensive FLAIR hyperintense signal signal in the cerebral white matter. Mild hyperintense signal in the brain stem and medial cerebellum. Following contrast administration there is no abnormal CNS enhancement. The adverse events resulted in Emergency room/department or urgent care and hospitalization for seven days from Jan2021. Treatment given was TPA to reverse adverse effects. The patient was not tested for COVID post vaccination. The outcome of events was recovered/resolved with sequel. No follow-up attempts possible. No further information expected.

diarrhea; color of the diarrhea looked red and looked like it had blood on it; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; shaking/trembling out of control; hurting from her neck down to her toes; joints were achy, hurt, and stiff; joints were achy, hurt, and stiff; her teeth were chattering and cant stop, and when she tried to stop that it made it worse; she had hard time walking/Her gait was off and she was kind of jerking; fell in the bathroom; she was too weak; hard time rolling and trying to get out of bed; Her gait was off and she was kind of jerking; little nausea; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea; she was kind of wiped out for a couple of days (in 2021) and it was all over now; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6203), via an unspecified route of administration in left arm on 27Feb2021 (at the age of 76years) as single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia diagnosed in 1999; Covid-19 from 23Nov2020 to Dec2020 (went to the hospital because of pain in her side at night. Was told she had pneumonia and pleurisy, she got it 2 days after her husband did, but hers was a mild case); her husband had Covid in Nov2020 and died in Dec2020 and hemorrhoids (from having babies years ago). Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN). The patient had no investigation assessment. The patient scheduled her first dose for 27Dec2021. The patient had questions about it, but the person administering it did not speak English and she said that initially she did not have any reactions while she was there. The patient received the first dose of the vaccine on 27Feb2021 and has a lot of adverse events. After the getting the shot, she woke up at 0400 and experienced shaking (whole body was shaking), trembling out of control, hurting from her neck down to her toes, her joints were achy, hurt, and stiff, her teeth were chattering and couldn't stop, and when she tried to stop that it made it worse, when she got up she had hard time walking, so much that when she had diarrhea, she had diarrhea on the floor, she also noticed that the color of the diarrhea looked red and looked like it had blood on it but she was not sure. After that, she sat down in a chair and noticed that it had blood when she got up and suspected that she had hemorrhoids and bleeding because of the diarrhea. She thought it was a result of the reaction to the shot. She noted that that she had COVID on 23Nov2020 and that she heard that people who had COVID might not need to get the second shot but it was only speculation so she was asking if this was true. She mentioned that she waited 90 days before getting the vaccine as per CDC guidelines and knew that the 2nd dose can be given for 42 days after the first dose. The patient's daughter in law who was an occupational therapist volunteered to fly in and take care of her after the second shot on 27Mar2021 but her 2nd shot was due on 20Mar2021 so she wouldn't be there until then. The patient was having a hard time rescheduling her appointment so asked if there was anything can be done. The patient would prefer not to take the second dose due to the side effects. The patient also reported that it looked like someone who had a stroke trying to walk again, her gait was off and she was kind of jerking. As she would take a step her foot would go down on a slant like it was skidding. She said that this happened one other time to her. It was like she was leaning forward and could not stop herself. When she was able to get up, she went into the living room and sat in her husband's chair and fell asleep until 15:00. When she got up, she noticed a lot of blood in the chair. The patient asked if this was allowed. She went home and took a couple of acetylsalicylic acid, caffeine, paracetamol because she did not have paracetamol (Tylenol), and she went to sleep. She had a hard time rolling and trying to get out of bed. She turned on her electric blankety and her heat. She said that by 0600 most of the shaking had gone away. She felt a little nausea, but got some dry toast. She said that she wanted to take a shower, but she started getting diarrhea from the injection. She fell in the bathroom and could not get herself up for over an hour because she was too weak. When she fell on the floor, she tried to get on a rug because she was still having the diarrhea on the floor. She said that it was everywhere. The next day she called her son and his wife they said that she could be alone for her second shot. She was scheduled for 20Mar2021 for her second dose. The patient had a hard time changing the appointment and her son could not come to stay with her until 27Mar2021. A friend told the patient that on the news it said that a second shot may not be necessary for people who have had Covid-19 already and she wanted to know if Pfizer has heard of this. The patient said that she was kind of wiped out for a couple of days (in 2021) and it was all over now. The doctor's office was aware of what happened and she was told to take extra strength Tylenol before and after the second injection to address these symptoms. The consumer considered the case as non-serious. The outcome of the event fatigue was recovered in 2021 while for the remaining events was unknown.

Felt dizzy as we were leaving the facility where I received the shot. Extremely dizzy and light headed for 5 days after that. Called to report the dizzyiness and they sent me to Urgent Care

Low oxygen noticed at doctors office, was rushed to the ER. Is now on oxygen 24/7. Drops extremely low with any movement.

she is not thinking straight; she is able to hear her heartbeat in her ears; having a ringing in her ears; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; She feels fuzzy in her head; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection lot no: EN5318), intramuscular injection in left arm on 01 Feb 2021 for covid-19 immunisation. the patients' medical history included ongoing high blood pressure and High cholesterol. The patient's historic vaccine included Shingrix for shingles on unspecified date in 2020. The patients Concomitant medication included Amlodipine 5mg tablet once a day orally, Hydrochlorothiazide 12.5mg tablet once a orally, Olmesartan 40mg tablet once a day orally, Meloxicam 7.5mg small tablet orally, three times a week, Preservision Eye Vitamin one soft gel capsule by orally, probiotic two gummies once a day orally, apple cider vinegar gummy two gummies once a day orally for Cholesterol, Citracal + D, calcium and vitamin d supplementation two tablets twice a day orally. on 01 Feb 2021, the patient experienced tingling/ numbness on tongue, lips, and roof of her mouth, felt fuzzy in her head. On 03Feb2021, she experienced Ringing in ears. The outcome of events was not recovered.

Fine after shot and evening; went to bed approximately at 9pm and got so cold, put 3 blankets on and was fine. Got up about 2AM to go to the bathroom; started back to bed; had a bad taste in mouth, so decided to brush my teeth. Started brushing and all of a sudden, felt faint; before I could get the toothbrush back, I fell and my husband rushed over. Said I was out completely; got me awake and back up and went to bed and slept. until 11am. At 3pm when taking a shower, noticed my left shoulder blade was real sore and looked and there were 3 red strips below should blade - no bleeding tho. top R. side of head kinda sore, so must have hit when falling. Went back to bed and slept good. Didn't need to go to the Dr. and am feeling good now. Just rested for a couple days. Had been feeling really good and don't take any prescriptions, so could only think it had to have something to do with the shot. Today is the 4th day and feel good.

Cardiopulmonary arrest at home @ 1 hour after vaccine administration. CPR by EMS to today hospital for asystolic cardiac arrest. Pt. Intubated then terminally extubated

heart pain; Shoulder pain; Neck ache; Stiff neck; severe chest pain; This is a spontaneous report from a contactable consumer (patient). This 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 23Feb2021 15:15 (batch/lot number: EN6198) as a single dose for COVID-19 immunization. Medical history included heart attack approximately 20 years ago). Family history included heart problems. Patient received unspecified concomitant medications. No additional vaccines administered on the same date of the Pfizer suspect. Patient experienced some side effects after receiving the first dose of the Pfizer-BioNtech Covid-19 vaccine. About 3-4 hour after she received the vaccine, on 03Feb2021 19:00, she had heart pain for around 5 hours, she also experienced shoulder and neck ache. These symptoms have resolved. She would like to know if she should receive the second dose of the vaccine, if these symptoms would be worse. Treatment for side effects: she put Spikenard, an oil, on the chest for the heart. At 15:10, she was fine, went home, had dinner, and then she first got shoulder pain/shoulder blade pain and then a stiff neck. Then she thought, she will go to bed and then had severe chest pain most of the night. Patient has never had flu or any vaccines. AEs did not require a visit to emergency room/physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event shoulder pain was recovering, of the event neck pain was recovered in 2021, and of the events heart pain, stiff neck, and chest pain was recovered on 23Feb2021.

1st vaccine on 2/20 and reported feeling "lousy" afterwards. On the evening of 2/23 felt like she was going to pass out. Felt worse when she woke the next morning. Presented to the ER on 2/24 with chest pain and "indigestion". Found to be in A.Fib with RVR. Vomited in ER triage. On 2/25 developed altered mental status, hypotension, hypoxemia. She was intubated and transferred to the ICU with severe lactic acidosis/shock/multiorgan failure. Had Right lower lobe infiltrate and right pleural effusion. Diagnosed with pneumonia and possible ischemic bowel. Died on 2/26. Family requested autopsy.

chest, back underarm pain; chest, back underarm pain; back pain; adhesions; Inflammation numbers were high; Clotting numbers were way high over 2000; pneumonia; This is a spontaneous report received from a contactable consumer. A 76-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in right arm on 01Jan2021 11:45 at single dose for COVID-19 immunisation. Medical history included thyroid, pancreas, and known allergies: Sulfa, k-flex, macrobid, statins, and pork. Concomitant medications included levothyroxine sodium (L-THYROXINE CAMPUS), vitamin B3, magnesium sulfate, and unspecified blood thinners. The patient experienced chest, back underarm pain two week later and did not get better. Patient had some adhesions and thought maybe from that. Patient had surgery and did not help. Pain kept getting worse. ED visit. On 04Mar2021, patient was diagnosed with pneumonia and sent home. After antibiotic, patient was no better. Another ED visit on 08Mar2021, clotting numbers were way high over 2000. Inflammation numbers were high. Patient was admitted every test available. 3 days in hospital. Patient was no better. Pain was terrible. Chest underarms and upper back. Patient was in serious pain and afraid to get second shot. Patient had cancelled. These adverse events were result in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. This case was reported as serious with seriousness criteria-caused/prolonged hospitalization. The patient underwent lab tests and procedures which included several computerised tomogram (CT scan): unknown results on an unspecified date, COVID test (nasal swab): negative on 08Mar2021, and X-ray: unknown results on an unspecified date. Patient was treatment for the adverse events. Outcome of the events was not resolved. Information on the lot/batch number has been requested.

fever, low blood pressure, high heart rate, anemia, fluid on lungs. hospitalized 2/19-2/23, 2/26-3/1, and 3/15-current

3/5 Anxiety attack with increased heart rate ...lasted about 20 minutes after taking one half of a cyclobenzaprine and full glass of waterand deep breathing; had another evening of March 10. much shorter duration.. After second shot, day after slight headache and bone tired...tiredness continues to present and my head feels like is has a vise or a helmet on it. Also have developed a kind of dermatitus but don't know for sure if I had it before and didn't realize it. I just want to sit down or lie down...My leg/butt muscles feel not up to the job...and in general thru today I just feel "off". Some days better than others.

Back hurt a tremendous amount; Lower back, hips, knees, neck pain; Lower back, hips, knees, neck pain; When she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes.; Very sore, uncomfortable stomach; Exhausted; Chills; Felt like she was having a heart attack; a bit congested; Aches; jaw pain; facial pain; Quite a bit of saliva in her mouth, it filled up quite a lot; sore on the injection site; Bit of a sore arm/left arm pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Right Arm on 02Mar2021 14:26 (Batch/Lot Number: EN619G) as single dose for vaccination. Medical history included joint replacements (specified as 1 hip done in 2007; right knee done in Jan2013; another knee was done in Feb2017; another knee was done in 1986); and in 2011, neck fracture. There were no concomitant medications. The patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and on 02Mar2021, she had sore on the injection site, experienced excess saliva production. On 05Mar2021, she experienced chills, feeling of heart attack: left arm pain, jaw pain, facial pain. She is worried to take the 2nd shot as she might have more symptoms on the 2nd dose. On an unspecified date, the patient had lower back, hips, knees, neck pain, eye socket hurts when rolling her eyes, sore stomach, and exhausted. It was also reported as follows: on 02Mar2021 after she got home from being administered the Pfizer-BioNTech COVID-19 Vaccine she had quite a bit of saliva in her mouth, it filled up quite a lot; and a bit of a sore arm for a couple of days but that was about it at that point. On Friday, 05Mar2021 she started getting chills and aches; and felt like she was having a heart attack: her left arm hurt and her left side of face hurt down in her jaw. She was afraid and considered going to the hospital but thought she was going to wait it out see what it is and it passed. She then once again got a lot of saliva in her mouth again. Over the next few days she developed aches that were primarily located in her joint replacements, it seemed like the aches attacked those areas of joint replacements in her hips, knees and where she had a neck fracture. She had a lot of pain and a lot of chills. She was never bedridden, but would lay down because she was exhausted. Her back hurt a tremendous amount. Another thing that happened is her eyes, when she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes; she did not have a headache; this whole indentation there with her eyes hurt to move them from one side to another. She also had a very sore, uncomfortable stomach; it was not an upset stomach; just seemed very sore, uncomfortable. At first that first part of 05Mar2021 she seemed a bit congested. She is very worried about second dose of Pfizer-BioNTech COVID-19 Vaccine because of the first dose creating all of these difficulties. She does not know what she should be doing. She is scheduled to get her second dose of the Pfizer-BioNTech COVID-19 Vaccine on 24Mar2021 because she is leaving by plane on 29Mar2021. That only gives her like 4-5 days before she leaves and she knows that the other symptoms after the first dose of the Pfizer-BioNTech COVID-19 Vaccine did not start until 3 days later. She is concerned about that, because she is flying to take care of her sister; she is worried about the second dose because she does not like what she experienced with the first dose because she heard that the second dose will be terrible; she is worried about leaving and experiencing those horrible things. She reported that there are no tests/investigations relative to this report to provide. The only thing recently done was having X-rays of her neck on 24Feb2021 because of her neck issues with the fractured neck she had in 2011. Outcome of the events was unknown.

has been experiencing high sugar level; having pain at tip of radius- sore to touch. Very sore; joint pain; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and via sponsored program . A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included diabetic. The patient's concomitant medications were not reported. The patient previously took steroid shots that cause blood sugars to sky rocket, but that was expected. The patient stated, "about the time I got the shot, started having pain at tip of radius- sore to touch. Very sore. No trauma there. It doesn't comes and goes. I'm aware of it" on 23Feb2021. The patient also said she has had increased blood sugars since the vaccine (readings of 197, 147, 154) on 23Feb2021. The patient further stated that she was looking at book and has had higher numbers of 197,147 and 154. Stated that she was usually 120 or below. Stated that she does not know if it had anything to do with it. Stated that the tip of her radius was terribly sore to the touch. Stated that it said that joint pain was a side effect on an unspecified date in 2021. Patient wanted to know if it was a side effect or just her own aches and pains. The outcome of all events was unknown. Information on the lot/batch number has been requested.

Diarrhea; Heart palpitation; occasional low pulse rate; sore joints; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection), first dose on 14Jan2021 at 12:45 (lot number: EL0140 and expiration date was unknown) and second dose on 04Feb2021 at 12:45 (Lot Number: EL3302 and expiration date was unknown) both administered in Left Arm via an unspecified route of administration at a single dose for COVID-19 immunization. Medical history included diabetes, CAD (coronary artery disease), aortic stenosis, COPD (chronic obstructive pulmonary disease), arthritis. Concomitant medication was not reported. The patient was not received other vaccines within four weeks of vaccination. The patient received unspecified medications within two weeks of vaccination. On 05Feb2021, the patient experienced diarrhea, heart palpitation, occasional low pulse rate, sore joints, and low-grade fever. The patient not received treatment for the events. The patient not had covid prior to vaccination. The patient not tested for covid post vaccination. The outcome of all events was reported as not recovered.

Chest tightness shortly after vaccination, sent to EC and admitted to observation and seen by cardiology, ruled out ACS and discharged in less than 48 hours

Patient was hospitalized from 3/11-3/15 for mental status changes. No obvious etiology found. On admission she was found to be + for SARS-Co-V2. She had no respiratory symptoms and was not treated. She was discharged to

Pfizer-BioN Tech COVID-19 Vaccine EUA: Swelling in mouth/lips, severe itching (all over, especially legs, thighs, back, arms, scalp, eyebrows and in nostrils, sensitivity to sound, elevated blood pressure, swelling in ankles, nausea

Received dose and tolerated it well. Over last week increasingly SOB, diarrhea and weakness. Of note family contact tested positive for She was admitted to the hospital - c Patient admitted to COVID unit as PUI, tested positive for COVID on 3/7. Required O2 and intubated with ICU admission. She remained intubated for 12 days. Her ICU course was complicated ARDS with severe hypoxemia, A.fib with RVR, mod-severe PFO with R to L shunt, spontaneous intraperitoneal bleed, septic shock, renal failure and ultimately multi-organ failure. Family made decision to transition to comfort measures only. She died shortly after extubation.

Faint; Fever; Dizzy; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in right arm on 20Mar2021 12:00 (Lot Number: EP7534) as single dose for covid-19 immunization at age 76 years old. Not pregnant at the time of vaccination. The patient medical history was not reported. No allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included lisinopril; amlodipine besylate; and carvedilol; all taken for product used for unknown indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 administered in right arm on 26Feb2021 12:00 PM (lot no: EN6202) for COVID-19 immunization at age 76 years old. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 21Mar2021, the patient experienced faint, fever, dizzy, and diarrhea. The events were reported as non-serious. No treatment received for the adverse events. The patient had not recovered from the events.

impacted stool; Impacted bowel movement; She actually tore and was bleeding really bad; exhausted; she had arrhythmia episode; This is a spontaneous report received from a contactable consumer (patient, self-reported). A 76-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199 and expiry date: 30Jun2021), via an unspecified route of administration, in Arm Left, on 09Mar2021 at 01:30 PM, as a single dose for COVID-19 immunization, at hospital and administered by a Nurse. Patient's medical history was not reported. Concomitant medications included rosuvastatin calcium, at 10 mg, 3x/day, (three days a week) and then at 5 mg, 4x/day, (5 mg four days a week); levothyroxine (50 ug) for Thyroid disorder and amlodipine besylate (2.5 mg) and had been taking fiber and probiotics. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Lot number; EN5318, expiry date; 31May2021, Received in right arm) for COVID-19 immunization; Had no problem with first COVID-19 Vaccine. No pain at site, nothing. Patient stated that she had arrhythmia episode and that was unusual for me; Since then I have had four more episodes in Mar2021. Patient stated that her second dose of the vaccine at 1:30 pm. The same day at 10 pm, she experienced an impacted stool. She stated that she was on the toilet from 10 pm-12:15. She wanted to know if this is a reported side effect of the vaccine. After receiving second dose, patient stayed 30 minutes and felt fine. At 10 PM felt that need to go to the bathroom, which she thought was odd. More than two hours she tried to pass a BM. It was so impacted she could feel it all around her anus. Was ready to go to the hospital. Didn't know what to do. Waited and waited sitting on the toilet. Was trying to see if she could dig anything out and it was non-productive. At 12:15 AM bowel movement finally left. It was 13 inches long and 3 inches around. She actually tore and was bleeding really bad. She usually drinks a lot of water, but was not able to the day of the second COVID-19 Vaccine. It was stated that total time of bowel movement impaction was two hours and 15minutes (Began 10PM on 09Mar2021 and passed at 12:15AM on 10Mar2021). She was not supposed to push with bowel movement impactions. Patient was told by Doctor, patient could get a heart attack or stroke from pushing impacted bowel movements. Patient was so exhausted and a very bad experience. No further details provided. Had a lot of vaccinations over the time due to living in Honduras for 2 years and traveling in Brazil. No further details provided. Scheduled mammogram fourth months from second dose. Patient did not receive other vaccines within 4 weeks or prior vaccination. She had a colonoscopy 6-8 months before the vaccine and had been taking fiber and probiotics. Outcome of the events impacted stool and Impacted bowel movement was recovered on 10Mar2021; for all other events it was unknown. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.

A fib; This is a spontaneous report from a contactable healthcare professional. A 76-year-old female patient received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered on right arm on 26Mar2021 14:30 (Batch/Lot Number: EP6955) at single dose (at the age of 76 years old) for COVID-19 immunisation. Medical history included have not been in Afib for 4 months prior. Concomitant medication included metoprolol, lisinopril and rivaroxaban (XARELTO), all taken for an unspecified indication, start and stop date were not reported. The patient received BTN162B2, dose 1 for COVID-19 immunisation. 1 hour and 5 minutes after injection (26-MAR-2021 15:35) of second dose, the patient went into a fib. Have not been in Afib for 4 months prior. The patient received no treatment. The outcome of the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of atrial fibrillation due to temporal relationship. Case will be re-assessed upon the additional information provided.

After receiving the 2nd dose of the Pfizer immunization, the pts blood pressure began to increase. It got to 210/120. Paramedics were called and responded promptly. Pt was left in their care.

For 3 days after I was so tired it was hard to get off couch. My Afib has been controlled but the afternoon of shot heart rate started to fluxuate. had appt with heart Dr. took EKG was ok but stated that there were several patients with same systems. by Thursday April 1st, heart rate was up to 143, called 911, by the time I got to ER it was going down. Had another EKG with in range and all other blood work was OK. Right ankle that swells because of arthritis swelling is now worse.

09:11 - 76 y.o. female with h/o Graves disease brought in by EMS presenting with altered mental status after COVID vaccine. The pt reports that she received the first COVID vaccine several weeks ago and immediately afterwards she felt warm and had some difficulty focusing and walking. This resolved and she has since felt well. Today at 0800 she had her second dose of the COVID vaccine. About 15 minutes later she had an acute change in her mental status. She became disoriented and slow to answer questions. She also started having difficulty walking. She was also noted to be hypertensive with systolic BP in the 200s. She was subsequently sent here by the doctor at the vaccine clinic via EMS. Currently the pt is feeling somewhat improved and more back to her baseline. She notes that she still does not feel quite herself. Notes that her symptoms feel similar to her reaction after the first vaccine except much worse. Sates she takes Levothyroxine but no other medications. She last had her thyroid numbers checked in January and they were somewhat "off."

Presented to emergency department with chest pain, report symptoms a few days prior to presentation. Reported mild shortness of breath, chills, and hot flashes. Was found to be COVID-19 positive upon admission to hospital floor. Symptoms are believed to not be related to COVID-19 infection and was not treated for infection.

is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no side effects from her first COVID-19 vaccine. After the 2nd one she had muscle aches, headache, freezing cold, and "weird", and felt really badly then at 9:30 PM, 32 hrs after the 2nd vaccine dose she felt the a-fib started. She had not been in a-fib in many years. Cardiology had already recommended eliquis but she was holding off. She had diltiazem from 2017 that she tried but with out relief. They rate controlled her but she remained in a-fib, started eliquis, and she went home. For 2.5 weeks she had headache and chest pain, other muscle pain, felt horrible, until she stopped the Eliquis. Since stopping the Eliquis, she still has occasional mild chest pain, and headache, and flushing. Her current chest pain is left chest, not radiating. The quality varies, stabbing pain in a very small location at times, may be associated with eating. She did have a stress test years ago and was "fine". She had a dental appointment planned that she had to cancel, she has moved it to May 4th.

Patient is here today for her second Pfizer vaccination. She reports that after the first vaccine, she felt very cold and had a sore arm for about 4 days. States that she took a 3-4 hour nap after she got home and the chills improved/resolved. Reports that she received the vaccine at around 10:00 AM. Was in the waiting area and was having some blurring of vision that was "coming in and out" and dizziness. She was taken to the personal observation area to lie down at 10:36 AM. Vital signs monitored. Blood pressure elevated, even though symptoms of blurring vision resolved. At around 10:55 AM, patient sat up on edge of cot. Continues to reports symptoms have resolved. No return of symptoms with standing. Patient walked well without the need of assistance. Husband accompanied her out of facility. Advised that, should blurring of vision reoccur, she should be seen in ED. Advised to schedule a blood pressure recheck with her PCP before the weekend. Patient acknowledged understanding of above information.

Death Cardiac arrest Hyperkalemia NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) ESRD needing dialysis (CMS/HCC)

FEELING VERY SICK. Pain is unbearable. arm is sore. Fast pulse. when I get up I feel like I am going to faint. Chills low fever, Pain in joints and muscles severe headache.

On 02/26/2021, 10 days after given the vaccine I was admitted to the hospital with a blood clot in my left leg and in both lungs. I was given Heparin, admitted, started on Xarelto, released on 02/28/2021. I will be on blood thinners for a at least 90 days.

Patient dreamt she was having a stroke around midnight (estimated) the night of her vaccine. Woke with LUE/LLE weakness and facial droop. Did not immediately report, but after persistent symptoms presented to ED 3/10 for evaluation. MRI showed early infarct right frontal lobe in setting of extensive chronic ischemic small vessel disease throughout the periventricular and subcortical white matter. MRA head/neck negative. EKG: NSR

Increased shortness of breath for a few weeks and then acute worsening of this along with new chest tightness on 4/30 which led to hospitalization and ultimately diagnosis of pericarditis. Atrial fibrillation also developed during the course of the 4 day, 3 night hospitalization.

03/17: Got 2nd dose of Pfizer vaccine 03/23: Pain started in chest and leg 03/24: Pain forced her to go to ER where it was discovered that she had a clot in her lungs and leg. Now on Xarelto

Two weeks after receiving vaccine, experiencing severe pain in under left breast, radiating around to the back. Chest pain and some breathlessness. I took her to the ER , on March 27, 2021, thinking it might be her heart. She was admitted for observation. She broke out with a severe case of shingles the next day, 3/28/21. She had been fully vaccinated for Shingles two years before (Shingrix).

Chest pain/stabbing pain on her chest wall at the right side; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot Number: EL9269; Expiration Date: unknown), via an unspecified route of administration, administered in arm Left on 30Jan2021 at 11:00 (at the age of 76-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included Lupus from 1976 to an unknown date. There were no concomitant medications. Prior Vaccinations (within 4 weeks) reported as none. History of all previous immunization and additional vaccines administered on same date with the Pfizer vaccine reported as none. Consumer reported that she had a side effect that she had never seen listed. She had no pain or redness at the vaccine site; but about 18:00 on Sunday night she had stabbing pain on her chest wall at the right side with no other symptoms. She took an aspirin and laid down because she couldn't move with the pain. The next morning she took another aspirin and laid in bed that day. It was bad for three days. The last time she noticed that the pain was on Monday. She was thinking that she had dodged a bullet because she was not having any pain at the site. Patient stated that she had friends, (name provided) and (name provided), in their 80s, who had pain from the elbow to shoulder, she spoke with them the day after they received their shots and they got there shot at the same time and place as the patient. Patient was scheduled to receive the second dose of the vaccine on 20Feb2021. She wanted to know that the chest pain a side effect and mentioned that she was concerned about getting the next dose. On 31Jan2021, the patient experienced Chest pain/stabbing pain on her chest wall at the right side. Therapeutic measures were taken as a result of chest pain and included treatment with aspirin. Patient did not required a visit to physician or Emergency room. Relevant test reported as none. The outcome of the event was recovered on 08Feb2021. No follow-up attempts are possible. No further information is expected.

Only has a little pain on my arm where I was given the shot; This is a spontaneous report from a contactable consumer reported for herself in response to Non-HCP letter sent in cross reference case. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included heart rate increased, blood cholesterol increased, hypertension from an unknown date and unknown if ongoing. Concomitant medications included ongoing metoprolol 25mg, twice daily, lisinopril 5mg once daily from Jun2020 for hypertension, ongoing atorvastatin (LIPITOR (ATORVASTATIN) 20 mg once daily from Jun2020 for blood cholesterol increased, ongoing levothyroxine, diphenhydramine hydrochloride (BENADRYL) from an unknown date to unknown date for unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration (Lot number: EL9261) as SINGLE DOSE for covid-19 immunisation causes rapid heartbeat was monitored, it keep going up and down/went to the emergency room. The patient only has a little pain on my arm where i was given the shot on an unspecified date. Drank a lot of water before after shot, Nurse suggested taking Benadryl after the shot which I did and had no reaction. The patient underwent lab tests and procedures which included heart rate increased: 135-120-110 bpm (Normal BPM 55-65 was up to 135-120-110 etc after vaccine (1st shot)), heart rate normal: 55-65 bpm (Normal BPM 55-65). The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown. Information about batch/lot number has been requested.

Irregular heartbeat. Lasted 12 hours. Had no adverse symptoms from this. Felt fine. Home BP machine registered 124/82. Pulse in the 80s.

This 76 year old female received the Covid shot on 2/27/2021 and went to the ED on 4/13/2021 and was admitted on 4/13/2021 with hortness of breath, abnormal lab, and returned to ED on 4/16/2021 and admitted on 4/17/2021 with vomiting, elevated troponin, dehydration and returned on 4/23/2021 and admitted on 4/24/2021 with rapid heart rate and acute respiratory failure and died on 4/24/2021. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Her legs got weak; she lost coordination; anxiety was exacerbated by her terrible fatigue; depression was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; She noticed that her blood pressure raised after receiving the first dose of the covid vaccine.; Total exhaustion/she is so tired; could not sleep; She experienced pain at the injection site./Her pain got worse and worse; left or right toe will get stuck; hysterical; she is stressed; did not have complete energy; She states that her illness is too much; This is a spontaneous report from a Pfizer sponsored program received from a contactable healthcare professional (patient). A 76-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscularly administered in the right deltoid on 30Mar2021 10:00 (Lot number: GR8732 or 6R8732 [as reported]; Expiration Date: 31Jul2021) as a single dose for covid-19 immunisation. Medical history included blood pressure/hypertension; had breast cancer twice with the last time was in 2010 to unknown date which was 23 years later than the first time she had it (1987). She had infiltrating ductal cancer, stage one, that was HER-2 positive. She states that this is the most malignant breast cancer. She had to have extensive chemotherapy and also took Herceptin every 3 weeks for a year. The overriding symptom from her cancer was extreme fatigue; has been in chronic fatigue syndrome and in bed for 7 years, she was getting over chemo and she can barely walk. She has trouble walking long distances; had a mastectomy from 2010 to an unknown date without lymph node dissection; had a central node dissection; took a wheelchair to the hospital whenever she received the first dose of the covid vaccine; ongoing anxiety, depression and nervousness which is not new to her. She has had this on and off for the past year; and antihistamine that raises her blood pressure dangerously, it does not matter which kind of antihistamine whether it is Benadryl or over the counter. The only antihistamine that does not raise her blood pressure was a children's allergy medication. She took half of a children's dose. It did not raise her blood pressure, but it did not stop her itching. Family history included her mother's sister and she are very sensitive to medications. She has the same type of problems. As her mother's sister has aged, her problems have gotten better. As caller gets older, her problems are getting worse. Concomitant medication included carvedilol taken for blood pressure on unknown therapy dates. The patient previously took dupilumab (DUPIXENT) for skin conditions that having itching which she had side effects (Lot number: 0LU23A; Expiration date: Feb2023). Dupixent is a medication used for skin conditions that having itching, not cirrhosis, she cannot remember the name of the skin condition. Her skin started itching around Jun2020 or Jul2020. She saw eight different dermatologists. She found a doctor who was an itch specialist. Dupixent is the only thing that is going to work for her because antihistamines raise her blood pressure dangerously; and one time her doctor made a mistake, he ordered her hydroxyzine 25mg PO (Per oral). The doctor did not look on her chart to see her allergy list. She cut the pill in half and took half a dose. By the time she realized what she took, she was having so much itching. She woke up and felt like her head was going to explode and her blood pressure was 220/112. She took three tablets of her antihypertensive medication. She taken carvedilol 3.125mg. She did not even bother going to the hospital because by the time they would have saw her, and treated her, she could have had a stroke. The hospital is slow to treat people. Because she is a nurse practitioner, she knew that 3 tablets would be the correct dose for how high (Apr2021) her blood pressure was. She also previously took Benadryl but that raises her blood pressure dangerously. The patient reported that she received her first dose of the covid vaccine on 30Mar2021 and she had many side effects. She reported that the most predominant symptom is total exhaustion. For the first seven days after receiving the first dose of the covid vaccine, she was in bed for seven days nonstop. She placed a large grocery shopping order. She was able to get up and use the bathroom and cook small meals. She had someone come in to help her with the dishes, and to clean up the house. She talked to her internist of 20 years, and he told her to take the vaccine. Within five minutes, she started getting side effects. She inquired if it was safe to take the second dose of the covid vaccine. She has been so fatigued that she has been in bed for a 3 weeks-time frame and then her Blood pressure went up, it was 200 something, like 223/103. She went to the ER, and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room, and because she waited so long, she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She added that the second week after receiving the first dose of the covid vaccine, she was able to get up every other day and go somewhere but the next day after she went somewhere, she was in bed all day and did not have complete energy (2021). She added that her refrigerator was going out, so someone drove her to department store 30 minutes away. She walked from the car, to the refrigerator section in department store, walked into the mall to get ice cream and then walked back to the car. By the time she got home, she immediately got back in her bed because she was so worn out. That was on Saturday. She was in bed all day yesterday. This morning, she feels better than yesterday. She thought about going to the store yesterday, but she knew she did not have the energy to go. Someone is coming later today to help her, and they will have to go to the store for her since she does not have any family nearby. She mentioned that the total exhaustion began on 31Mar2021. She took a wheelchair to the hospital whenever she received the first dose of the covid vaccine. She has trouble walking long distances. She called the hospital before she went, and the hospital did not have any wheelchairs she could use. The hospital cleared everything out of the way so they could fit the most patients as possible in the building. She had trouble walking the day that she received her first dose of the covid vaccine. Someone wheeled her in and out using her own wheelchair. She cannot go to the grocery store. Using a wheelchair is the only way she could have in and out. She could walk from her wheelchair into the examination room, and then after she went right back into her wheelchair. She is glad that she called because she does not know what she would have done without a wheelchair. It is hard for her to go on, sometimes she just feels like crying. Her trouble walking does not feel 100 percent, but it has gotten better. She is anxious, depressed and nervous also. Before her breast cancer, she had chronic fatigue. She could volunteer at a clinic for a few hours a week. She had radiation, and that caused exacerbation of her chronic fatigue. Her doctor told her that for some people, chemotherapy will make chronic fatigue better and that chemotherapy could help her chronic fatigue. Before she got chronic fatigue syndrome, she had a lot of energy. She used to work in an ICU that had 15 patients, with ambulatory patients on the outside. She worked six days a week then she transferred to a hospital where she took care of patients after they had open heart surgery. She used to be a very high energy person. Her exhaustion has gotten better, because she can get up every other day and leave the house. She cannot stop doing life. It is difficult for her that she cannot go to the grocery store. After seven days, she could go out every other day. Whenever she went to a certain company, she almost fell. Her legs got weak and she lost coordination on Tuesday (06Apr2021). Since then, it has happened a little bit here and there. It is almost like she is not sure when it will happen. In an instance, she can be working in the house, and her left or right toe will get stuck. This happens to her occasionally after chemotherapy. She noticed that her blood pressure raised after receiving the first dose of the covid vaccine (Apr2021) and she takes medication (small dose of carvedilol) for hypertension. She takes her blood pressure medication every other day. Out of the past four days, her blood pressure has been elevated twice (Apr2021). If her blood pressure is elevated more than normal, her doctor prescribed for her to take an extra dose. Her blood pressure has not been elevated dramatically. She did take an extra dose of carvedilol because her blood pressure was within the scope of her blood pressure expertise. She went to the ER and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room and because she waited so long she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She also stated that her blood pressure went up yesterday last night (18Apr2021), not right after getting the first dose. Last night at 6:00 PM, she took a nap and after she woke up took her blood pressure, she didn't feel anything in specific, she always takes her blood Pressure pill twice a day anyway. When she checked her pressure, it was 223/120 (Apr2021) and immediately took 2 Carvedilol 3.125mg and went to the ER, by the time she got there it was down significantly (Apr2021), but she is anxious and sat there and waited. They said they were going to do some blood work and an EKG but they left her there, so she decided to take a company home. Her Blood pressure has been up, she then went to sleep and after (Apr2021), it was 189/105, 183/105, and 165/95, she is a nervous wreck. She was ill for a long time, she had cancer twice, now she lives alone, she has been alone for all these weeks, her friends are here and there and come over. The Last 3 weeks she has been alone. She hired someone, but it was expensive. Now she feels hysterical (2021), after she saw her blood pressure, last night she was crying, and called the neighbor and they drove her right to the hospital then she was waiting in the ER for so long. She got her first shot on 30Mar2021 and she couldn't do anything in bed for 7 days, she is supposed to get the second shot tomorrow (20Apr2021) but doesn't want to be in bed again like that. She is anxious, depressed and nervous that began on 03Apr2021. During the week, she is distracted by the market. She has not been able to trade, because she does not trust her judgment right now. She did buy one this morning. Anxiety, depression and nervousness is not new to her which she has had this on and off for the past year. She has a lot going on. She needed to sell her two-story house and move to a one-story house that is easily assessable to healthcare and meals. She thinks this is disabling in face that she does not feel strong enough to make a decision. She cannot make a decision and she does not feel good enough too. Her anxiety, depression and nervousness was exacerbated by her terrible fatigue. She is experiencing awful symptoms. She went to the grocery store, and the stumbled and went into a company. She had to carry her milk and other items in slowly, and little by little. She thought this is awful, and she got into bed. She could not do anything. She mentioned that her illness is too much (2021). She was crying and she lives alone. The patient mentioned that the pain at the injection site began four hours after receiving the first dose of the covid vaccine. She received the vaccine at 10:00 AM then started getting really bad pain about 6:00 PM and then about 10:00PM or 11:00PM, it started to get unbearable. By 12:00AM (31Mar2021), the pain was so bad that she could not sleep because of the pain. She was in agony. She took took Tylenol and it did not touch her pain, but her pain got worse and worse, so she took three Tylenol tablets then they worked. She her friend and asked him to come over since she is afraid to take narcotics. She just laid there in bed and spent all night in agony. She tried a thing she put in the freezer and tried heat. She does not remember if either of those worked. The pain resolved about 2 days after. The patient declined safety report, saying that she is stressed and anxious (2021), she just wants to be transferred for her question. The reporter considered the events fatigue aggravated serious and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as medically significant. The outcome of the events fatigue aggravated recovering; as for the events blood pressure raised, 'anxiety, depression and nervousness was exacerbated by her terrible fatigue', lower extremities weakness of and coordination impaired were not recovered; while the event vaccination site pain was recovered on 01Apr2021 (reported as 2 days after). The outcome of the other events was unknown.; Sender's Comments: Based on the information provided, the events fatigue aggravated and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as serious (IME).Based on the plausible temporal association and product safety profile, the reported events are possibly related to the vaccine BNT162B2. administration. This case will be reassessed upon receipt of additional information.

Blood clot in her lower abdominal area; had the worst pain through her side that ran down her left leg and to her ankle; had the worst pain through her side that ran down her left leg and to her ankle; nerves are all tangled up; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Arm Right on 17Mar2021 13:50 (at 76-years-old) as single dose for COVID-19 immunisation. The vaccine was administered at a hospital. It was not administered at a military facility. Medical history included hip replacement four years ago in 2017 (First right then 2 months later left) and knee replacement six years ago in 2015 (both 2 months apart). There were no concomitant medications. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6203), administered in Left Arm on 25Feb2021 (at 76-years-old) for COVID-19 immunisation and experienced bad headaches. The patient received the second dose of vaccine on 17Mar2021. On 29Mar2021, she was not hurting and went to brunch with friends. Afterwards (on the same date, 29Mar2021), she was sitting and got the worst pain through her side that ran down her left leg and to her ankle. She drove herself home but was in such misery. She went to the emergency room the next day, on 30Mar2021, wherein she had a CT (computerized tomography) scan that showed a blood clot in her lower abdominal area. She was taking pain medication every 6 hours, or she could hardly stand it. On 08Apr2021, she went back to the emergency room because she could hardly stand it. She was kept in observation status but was not admitted. She was scheduled to have another CT scan on 06May2021. She is not sure what they will do because the nerves are wrapped around it. She also mentioned that her doctor wants to do a biopsy. The pain was also running down to her ankle. She stated that she has had both of her hips replaced in the past. She added that her doctor will do an MRI (magnetic resonance imaging). He will put in a drain if it has not shrunk. The doctor can't do anything because the nerves are all tangled up (2021). As corrective treatment, the patient was taking pain medication for the blood clot and pain through her side that ran down her left leg and to her ankle. Outcome of nerves are all tangled up was unknown, while outcome of the other events was not recovered.

03/09: presents to the ED with palpitations that began 90 minutes prior to arrival. The patient has a history of paroxysmal atrial fibrillation but has not had an event for many years. She had her second Covid vaccination yesterday and did have flulike symptoms including headache, myalgias, and shakiness through the last night. She wonders if this triggered her symptoms. No chest pain, dyspnea, or lightheadedness. 23: 18. Cardizem 17.5 mg IV. 03/10 still in ER 00: 17. The patient is discussed with hospitalist. would not recommend admitting the patient given her stability. The patient's atrial fibrillation responded very well to the IV Cardizem. Her atrial fibrillation is now in the 80s. She is asymptomatic. CHA2DS2-VASc score of 2. 00: 18. Cardizem 30 mg p.o. The patient is quite concerned about stroke. Her mother died of CVA. We will start anticoagulation today pending cardiology follow-up. Eliquis 5 mg po. Recommended follow up with cardiology 03/16 visit with cardiology Paroxysmal atrial fibrillation Established Recently symptomatic with RVR after Covid vaccination Rhythm controlled with flecainide 100 mg twice daily Rate controlled with diltiazem 120 mg daily ? CHA2DS2-VASc Risk Factors/Score: AGE(>=75), Female Gender and 3 points: "moderate-high" risk - Stroke risk as 3.2% per year and 4.6% risk of stroke/TIA/systemic embolism. o HAS-BLED Risk Factors/Score: Age > 65 years and 1 Points - "Low Risk" - 3.4% annual risk of major bleeding in one validation study and 1.02 bleeds per 100 patient-years in another validation study. Continue Eliquis 5 mg twice daily for embolic prophylaxis (creatinine 0.76 on 3/9/2021) 04/02 appt with PCP for ER follow up Patient is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no side effects from her first COVID-19 vaccine. After the 2nd one she had muscle aches, headache, freezing cold, and "weird", and felt really badly then at 9:30 PM, 32 hrs after the 2nd vaccine dose she felt the a-fib started. She had not been in a-fib in many years. Cardiology had already recommended eliquis but she was holding off. She had diltiazem from 2017 that she tried but with out relief. They rate controlled her but she remained in a-fib, started eliquis, and she went home. For 2.5 weeks she had headache and chest pain, other muscle pain, felt horrible, until she stopped the Eliquis. Since stopping the Eliquis, she still has occasional mild chest pain, and headache, and flushing. Her current chest pain is left chest, not radiating. The quality varies, stabbing pain in a very small location at times, may be associated with eating. 04/20 ER visit: Patient is a 76 y.o. female who presents with palpitations that started this evening, sudden onset, has a history of paroxysmal atrial fibrillation, and is maintained on 100 g of flecainide twice daily and diltiazem daily. She also has short acting diltiazem 60 mg tablets to take for episodes of breakthrough arrhythmia. She took a 60 mg short acting diltiazem prior to arrival She endorses some chest pressure with this though not severe, denies any dyspnea diaphoresis or nausea Not anticoagulated 04/29 Follow up with PCP For years she has been well controlled on low dose methimazole. Recently she has had 2 bouts of a-fib, when trying eliquis prescription and again following her 2nd COVID-19 vaccine. Upon recheck her TSH remains suppressed and FT4 elevated. Increasing from 5 to 10 mg methimazole now. Left side of thyroid is palpably thickened with no nodules noted. Recommended Ultrasound. Explained that if nodules are seen, a follow up image may be indicated to assess nodule activity. Not in a-fib today. C/o general malaise, shakiness, chest tightness, & flushing. Graves since 2006 She is feeling out of sorts, shaky, flushing, chest tightness, recurring headache. She has to stop and rest when trying to do activities as she will feel weak. Not sleeping well. Systolic BP labile, from 105, to 155, to 135.

Dizziness and left side pain/discomfort around chest area (5/10). Pt received 2 L of O2 via NC and 325 mg of ASA. Vitals stable. Pt did not take BP med today, pt agreed to take her Benicar 20mg when escorted to her car (med in car).

Patient completed 2-dose Pfizer series on 1/31/21 and passed away on 2/13/21. Pt presented to ER on 2/11/21 with SOB, weakness, diffuse abdominal pain and diarrhea that started that day. Pt tested positive for COVID and was transferred out to a higher level of care. 1st dose: 1/5/21, 2nd dose: 1/31/21

This 76 year old female received the Pfizer Covid shot on 2/27 /21 and went to the ED on 4/3/21 and was admitted on 4/3/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) I63.9 - Cerebral infarction, unspecified

Butterflies in the chest that went to quivering; quivering; A-Fib/Arterial fibrillation with rapid ventricular response; Arterial fibrillation with rapid ventricular response; cannot rule out anterior infarct and abnormal EKG; cannot rule out anterior infarct and abnormal EKG; trouble breathing; Her heart rate is screwed up; she feels so weak; irregular heart beat; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Mar2021 (lot number: EP7534) as SINGLE DOSE for COVID-19 immunization. Medical history included asthma, chronic obstructive pulmonary disease (COPD), irritable bowel syndrome described as a condition where you're in the bathroom a lot, fibromyalgia, little depression, heartburn, upset stomach, heart fluttering issues, congestion spray (nasal congestion), and had part of a lung taken out. Family medical history included heart issues (dad and uncle). Concomitant medications included salbutamol (VENTOLINE [SALBUTAMOL]) for asthma; venlafaxine hydrochloride (EFFEXOR) for little depression; pantoprazole for heartburn and upset stomach; fluticasone propionate (lot number: AA47468, expiration date: Aug2020) for congestion spray (nasal congestion); fluticasone propionate, salmeterol xinafoate (ADVAIR) for heart fluttering issues. The patient previously took SHINGRIX (also reported as shingles vaccine, for clarification) for immunization and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) on 25Feb2021 (age: 76 years) in the left shoulder for COVID-19 immunization. On 18Mar2021, right after taking the vaccine, patient started to experience quivering inside. Initially it felt like butterflies in the chest and then to quivering, it was then quivering the whole week. She knew she was going in for a test , an endoscopy, where they go down the throat. So she waited, the quivering did not go away for a whole week. It lasted until Friday before her endoscopy. When they found out, they sent her to ER at the hospital. They did not do the endoscopy. They said they might have to shock her heart or something. They wanted her to see the cardiologist right away. From the ER, she had 2 IVs, 1 in each arm. They were also taking blood every 4 hours (unknown results). The provided diagnosis was arterial fibrillation with rapid ventricular response and cannot rule out anterior infarct and abnormal EKG (Mar2021). The events cannot rule out anterior infarct and abnormal EKG, butterflies in the chest that went to quivering, A-Fib/Arterial fibrillation with rapid ventricular response resulted in emergency room visit and physician office visit and let to hospitalization. The patient was hospitalized from 2021 to an unknown date (also reported for 2 days, for clarification). It also gave her A-Fib, trouble breathing and now her heart rate is screwed up (Mar2021). On an unspecified date in 2021, she feels so weak and has irregular heartbeat. Therapeutic measures were taken as a result of the events which included Eliquis, Atorvastatin, Diltiazem, and other unspecified medications. The outcome of cannot rule out anterior infarct and abnormal EKG, butterflies in the chest that went to quivering, arterial fibrillation with rapid ventricular response, she feels so weak was not recovered; while the other events was unknown.

This 76 year old female received the Pfizer Covid shot on 2/15/21 and went to the ED on 4/6 /21 and was admitted on 4/6/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified GI Bleed

Diziness, chest pain. Given Oxygen 2L via nasal cannula and ASA 325 mg PO. Patient saw cardiologist 2 months ago for valvular disease, not a candidate for surgery, does not have any NTG Rx, does not take her ASA or Benicar regularly (did not take them today). Symptoms resolved, patient stable & released from vaccination site.

This 76 year old black female received the Covid shot on 2/27/21 and went to the ED and was admitted on 3/17/21 and again to the ED and admitted on 4/7/21 with the diagnoses listed below. Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction Non-ST elevation (NSTEMI) myocardial infarction Epistaxis

Pt presented with coffee ground emesis and acute st elevation myocardia infarction. She was DNR. She was admitted and expired in a few hours.

Systolic pressure for five days up to 220 - Added extra blood pressure medicine in the middle of the day. That kept the systolic pressure slightly under 160. Diastolic pressure was never over 75. Symptoms were sweating, heart pounding, headache, and fatigue.. Resolved itself on May 16, 2021 at approximately 6 p.m. when blood pressure again registered 125/74.

After vaccine on Wednesday three fingers on my right hand went numb and my mouth felt like I had a shot of Novocain, then my tongue had a little tingling. I texted my doctor and he said to go to the ER and they checked me out did EKG, blood work, CAT scan, covid test that was negative and I was admitted. I got an MRI and did other urine test, I was being checked every hour. I was given Plavix and other meds and was told that I had a stroke/TIA.

Dizzy,Fever, Disoriented, (expected: arm soreness, heat, swelling administered frozen pea bag) rash on forearms,, not hives, passed out for 9 hours I thought I would just relax with my frozen peas and watch tv. 9 hours later, I was slumped on the couch, tv had not been turned on , I was fully dressed including shoes, no blanket or pillow, very cold all the lights that I had turned on were still on and it was 5:10 in the am I had not brushed my teeth or taken evening medication. I had warmed left overs in the oven thinking I might just be hungry. Oven was off but oven door was open food was uneaten except for a couple of bites. I live alone. I still work and manage everything on my own.

Pt recivied her 2nd covid 19 vaccine on 3/26. Patient is a 76-year-old female with a past medical history significant for hypertension, depression, hypothyroidism 2nd covid 19 vaccine on 3/26 who presented on 5/18 to the ER with complaints of lightheadedness and nausea that occurred over the weekend and was diagnosed with new onset rapid atrial fibrillation. She denied chest pain or shortness of breath but noticed intermittent bouts of palpitations. She went to see her PCP who referred her to the emergency room. EKG and telemetry in the emergency room were significant for new onset rapid atrial fib. She was given diltiazem and admitted to the hospitalist service. CT of the chest was negative for pulmonary emboli or focal consolidation. She had no electrolyte derangements she has no history of sleep apnea and no history of obesity. Her troponin and delta were unremarkable. She was subsequently admitted to the hospitalist service. She was treated with metoprolol and amiodarone along with Eliquis. She was seen by her cardiologist. Her recent echocardiogram was normal. Her TSH was actually elevated at 11.0 so her levothyroxine dose was increased to 175 mcg daily with a TSH in 6 weeks. At this time patient's rate is much better controlled but she remains in atrial fib. She will be following up with her cardiologist closely post discharge. She is also complaining of persistent R shoulder pain and weakness since her vaccine. Her shoulder x ray showed arthritic changes. She also c/o the worst headache of her life that lasted a week starting on May 4th. CT head was neg.

Rapid heart beat at 138-144 bpm with both doses, with blood pressure spikes, that lasted for hours, resulting in hospitalization, continued medial monitoring, medication, continued medical follow up and testing.

Hypoxia & Shortness of breath Chief Complaint Patient presents with ? Shortness of Breath x 3 days, denies any cough, congestion, or fever. daughter is with her. Oxygen very low 74, provider notified right away and he came into room. ED to Hosp-Admission Discharged 4/15/2021 - 4/17/2021 (2 days) Last attending ? Treatment team Aspiration pneumonia of left lower lobe, unspecified aspiration pneumonia type (CMS/HCC) Principal problem Hospital Course HPI: a 76 y.o. female presenting to the ED with chief complaint of chest pain and shortness of breath. Patient is being seen in the emergency department for evaluation of the above, here with her daughter. Patient was seen and evaluated by local urgent care and referred here for evaluation. Is reported that patient was hypoxic. Patient's daughter also states that they have been monitoring her oxygen saturation at home and it has been in the 60s and 80%. Patient does report a cough. She has been using her inhaler more frequently. Received her Covid vaccination 2 days ago. Hospital Course: Patient was admitted and placed on supplemental O2. Chest x-ray 4/15/2021 showed some opacity at the left costophrenic angle effusion with some areas of atelectasis possible. Chest CT performed on 4/16/2021 revealed small areas of consolidation/infiltrate in the right upper and left lower lobes of the lungs, emphysema, and a 3 mm pulmonary nodule in the left upper lobe. Small bilateral pleural effusions have decreased since CT of12/11/2020. Initial CBC revealed white blood cell count of 9.3. Hemoglobin and hematocrit were stable at 8.8 and 29.4. Renal function was stable as well. Glucose on 4/16/2021 fasting was 222. Magnesium was at goal at 2.5. Procalcitonin levels were performed and were 0.19. She was initially started on IV vancomycin and cefepime as well as Flagyl due to possible aspiration pneumonia. On 4/17/2021, patient was adamant on being discharged. She did discuss possibly signing out AMA. I did explain to her the ramifications of that. She voiced understanding. I also discussed this with her daughter, as well. She required 4 L of supplemental O2 and achieved an O2 sat of 93%. On room air patient was 78%. Therefore, home O2 was ordered. IV antibiotics were changed to oral Levaquin 250 mg to take 1 by mouth daily (based on renal function) for 7 days and generic Flagyl 500 mg to take 1 3 times a day for 7 days. She was instructed to take antibiotics as prescribed as well as use supplemental O2. She was also advised that if symptoms worsened she was to return to the emergency room. At time of discharge she was stable with supplemental O2 in place. ED to Hosp-Admission Discharged 4/28/2021 - 5/4/2021 (6 days) Last attending ? Treatment team Hospital Course HPI: a 76 y.o. female with a past medical history of systolic and diastolic heart failure, diabetes mellitus type 2, above-the-knee amputation of left lower extremity, who comes from home where her oxygen saturation as per the daughter was 25%. She was recently discharged from here on 4/17/2021 for left lower lobe pneumonia. She does not want to be in the hospital. She states that she felt fine when she came in this time. She was evaluated by the ICU who stated she is a DNR/DNI and felt that with BiPAP modification she was satting better. She was adamant that she wanted to leave the last time she was here and went home with oral Levaquin and Flagyl. When she arrived, nursing states that there was dried stool on her bottom. The patient denies any current shortness of breath. She wants her BiPAP mask removed as it is uncomfortable to her. After explaining it as needed she agreed to have it on. She denies any abdominal pain, she denies any chest pain. She denies any fevers or chills. Hospital Course: Patient was admitted for acute on chronic diastolic CHF, acute on chronic hypoxic respiratory failure secondary to CHF and COVID-19. Patient was also treated for elevated blood pressures. Cardiology was consulted, patient was placed on Lasix twice daily and was started on hydralazine for blood pressure. From pneumonia standpoint, patient started on Zosyn, for COVID-19 patient was started on Decadron and remdesivir. Patient finished a course of remdesivir in the hospital. Patient went from using 5 L oxygen to only 1 L, meanwhile chronically she has been using 3 L at home prior to coming into the hospital. Patient has not been requiring any further BiPAP. She has been afebrile for more than 48 hours. Today nephrology recommended to lower Lasix down to once daily instead of twice daily to avoid kidney injury. Patient is medically stable for discharging home today to finish her course of Augmentin and Decadron. Patient appears to be very hesitant about having to continue self isolating. Family understands the need for further isolation. Patient will receive a remote monitoring kit upon discharge. ED to Hosp-Admission Discharged 5/10/2021 - 5/17/2021 (7 days) Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Hospital Course HPI: Patient was admitted with hypoxia and pneumonia due to COVID-19 virus. For details please see the history and physical. Hospital Course: Patient had previously been diagnosed with COVID-19 pneumonia about 3 weeks ago and had been treated with remdesivir Decadron and antibiotics. She was now admitted with pneumonia and hypoxemia. Her oxygen requirement went up and she was at 1 point requiring high flow oxygen up to 15 L/min. Subsequently her oxygen requirement was able to be tapered. She was treated with steroids during this hospitalization. Her oxygen requirement is now down to 4 L/min. She is feeling better. She is now felt stable for discharge with outpatient follow-up with her PCP. Steroids have been stopped on discharge. Her daughter was regularly updated during this hospitalization. I called and left a message at the time of discharge today.

Large oval patch (plaque?) rough around the border, smooth and paler color inside. 1" long. Center of my back (I have a photo) I just noticed it yesterday. No treatments.

blood pressure was 174/106/blood pressure shot up to 198/116/blood pressure shot up to 175/106; 93 pulse/99 pulse/109 pulse; This is a spontaneous report from a contactable consumer, the patient. A 76-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration, administered in right arm on 21Feb2021 16:00 (at the age of 76-years-old) as a single dose for covid-19 immunization. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration, administered in right arm on 31Jan2021 16:00 (at the age of 76-years-old) as a single dose for covid-19 immunization. Medical history included, blood pressure abnormal, blood cholesterol abnormal (was on blood pressure medication for many years; after losing 20 pounds did not need it anymore; take Crestor 10mg for cholesterol (total around 160)) and had allergy with rubber (latex band aids). Concomitant medication(s) included vitamin d3; rosuvastatin calcium (CRESTOR). On 21Feb2021 16:30, the patient reported about 1-2 minutes after receiving 2nd shot on 21Feb2021 "I could feel a reaction. I waited 30 minutes before leaving to make sure it wasn't anaphylaxis. When I got home my blood pressure was 174/106/93 pulse. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Feb2021 blood pressure shot up to 198/116/99 pulse. On 01Mar2021 blood pressure shot up to 175/106/109 pulse. After the first shot, the patient had slight rise in blood pressure and pulse after about 5 days but otherwise just felt tired". The patient recevied treatment with benicar 40 mg and lorazepam 5 mg, zicam. Outcome of the event was recovered with sequelae (recovered with lasting effects). No follow-up attempts are possible. No further information is expected.

I63.9 - Cerebral infarction, unspecified N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia R56.9 - Unspecified convulsions

Medic responded emergency reference allergic reaction at vaccine clinic Medic to find 76/f seated in drivers seat, c/o nausea immediately after receiving vaccine. EMS standby staff on scene. Pt stated she had received vaccine approx 30 minutes prior to EMS arrival and began to feel ill <15 minutes later at which time standby EMS crew were alerted and in turn alerted transport. Pt has extensive list of allergies, including many antibiotics. Pt was A&OX4, pink warm and dry w/ good ABCs/PMS upon EMS arrival. Pt had no apparent life threats/injuries, was PEARL, equal lung sounds. Upon being placed in ambulance pt began to complain of dull ex pressure 2/10. 3 lead displayed sinus rhythm w/ PVCs which pt stated was her normal per pt cardiologist and that she was medicated for same with herbal medication.12 lead obtained, no elevation or depression noted, PVCs still noted, otherwise unremarkable. R-IV access attempted x2, good flash vein blew. 3 and 12 lead obtained to rule out cardiac involvement and monitor for changes. Given reference pt statement of positive ex pressure. Zofran considered, Medic was already at hospital when last IV was unsuccessful, PO zofran not given. No further interventions. Pt moved to stairchair via stand and pivot with assistance, secured via straps and moved to stretcher, pt placed in stretcher via stand and pivot with assitance, covered for comfort, secured via straps/siderails and moved to ambulance without incident. Pt and pt vitals monitored for duration of routine transport. Pt report called for prior to arrival. Upon arrival pt offloaded and moved to bed in ER via sheet draw without assistance. Pt care report given and pt care transferred to ER RN. Medic checked back in service. 76-year-old presenting with nausea and general malaise. Symptoms started about 15 minutes after receiving her COVID-19 vaccine around 2:30 PM. She has been nauseous but had no vomiting. Slight central chest discomfort with palpitations. Also feeling somewhat dizzy. She did not receive any medications. EMS was called and brought her to the ED. Denies any itchy skin, abdominal discomfort, sensation of throat swelling or pain. No wheezing or difficulty breathing. She has had anaphylaxis to medications in the past but she is unsure exactly which ones except for codeine. 76-year-old presenting with possible reaction to the Pfizer COVID-19 vaccine. Constellation of symptoms are not consistent with anaphylaxis but may represent a different type of allergic reaction. Will give Zofran for nausea, Benadryl, and observe. Basic labs and EKG. KG My interpretation of EKG Normal sinus rhythm. Normal axis and intervals. No acute ST elevations or depressions. Reexamination/Reevaluation Patient was observed for over an hour without any progression of symptoms. Her nausea improved with Zofran. No episodes of vomiting in the ED. Discharged with plan to follow-up with her PCP, continue symptom management at home. Diagnosis/Disposition Nausea without vomiting atient Instructions Continue your regular medications as prescribed. Use Zofran 4 mg every 8 hours as needed for nausea. Follow-up with your doctor within the next 1 to 2 days for recheck. Return to the ED if you develop severe difficulty breathing, severe chest pain, intractable nausea and vomiting or have other concerns. RX Given ondansetron: 1 tab, PO/SL, TID, nausea/vomiting, # 10 tab, 0 Refil(s)

Patient was found to have NSVT on recent pacemaker check. This occurred 4 days after receiving her 2nd Pfizer COVID-19 vaccination. Patient states it was a 'blip' on her device. She had no further other symptoms noted. Patient is unsure if is related to the vaccine or if this was something else related to cardiac history. Her primary care provider did ask that she report this.

She had high Blood pressure yesterday; Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose; started getting hungry; she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs; swelling under her eyes/eyes started getting swollen; face was swollen; Eye infection; face felt tight; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EM9810; NDC number: Not Provided Expiry Date: Unknown) via an unspecified route of administration on the left arm on 06Feb2021 at 8:31AM (at the age of 76 years), as a 2nd dose, single dose for COVID-19 immunization. The patient medical history included disc protruding (diagnosed before the covid vaccine in Jun2020 or around that, she recalls having several months of MRI's in 2020) and high blood pressure. The patient's concomitant medications included Epidural Shot (Verbatim) for Protruding Disc Patient on 27Jan2021 (she had to go to the doctor in the clinic and get epidural shot in the back at the disc thats protruding). Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EL3249; NDC number: Not Provided, Expiry Date: Unknown) via an unspecified route of administration on the left arm on 16Jan2021 at 12 PM (noon) as 1st dose, single dose (at the age of 76 years) for COVID-19 immunization. Clinical course: She took second dose of Pfizer Covid Vaccine on 06Feb2021, though she had no reaction initially. A week later from vaccination on Feb2021, she then began to notice her eyes started getting swollen couple days after, she then felt like her eyes felt like they were closing, then she saw her whole face was swelling, it looks like she had Chipmunk cheeks. She went to the doctor hoping it would go away, she was prescribed Benadryl and a decongestant as treatment. She takes Benadryl three times a day and the decongestant in the morning and her face is still swollen. It started with the eyes and the bag under the eyes, that was the first thing she noticed. She laughs and though she initially had an eye infection. She just wants to know if there is any other reports of this happening, or how to get rid of it, this has been there since she got her second dose on the 06Feb2021 since like 10Feb2021. After the second vaccine on 06Feb2021 around that time an hour later, she was on the way home and started getting hungry, she thought that was a symptom as well as her arm hurt a bit. She was starving till Monday got up 2AM, 6AM ate all day Sunday and Monday ate all day, as reported "all she knows is she was craving a crab sandwich." Her Eyes swelling started a couple days later and the Face swelling was either the second week or same time, she just recalls looking at the eyes. She recalls telling her son her face felt tight in Feb2021. At the doctors appointment she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs, she is a small girl. The Appointment with the doctor was yesterday (15Mar2021), they prescribed Benadryl. Patient clarified that she was not Prescribed Zyrtec, it was a decongestant but she does not know the name of it. The Druggist however told her she could take another medication also. As reported "The eye swelling and face swelling, at the moment she look like she been drunk, her face is plentiful, she is still swollen, her lids are not bad, but it is ongoing, it has gotten worse because prior she didnt even know it was there and its showing more now. She asked son if he thought she was swollen because she feels tight, over the weekend her face being swollen was noticeable, she is noticing people are pointing it out now." She adds her arm did not hurt with first dose. Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose and the next day (07Feb2021). She thought initially that she didn't have any side effects. She had High blood pressure yesterday (15Mar2021), but that usually goes up and down for her and nothing new. It was reported that, a week later, patient experienced swelling under her eyes, face was swollen, eye infection and face felt tight on Feb2021; hunger and vaccination site pain on 06Feb2021 (reported as the day she got this dose); hypertension on 15Mar2021 (reported as yesterday). Patient would like to know if swelling of the face is a reported side effect from the covid vaccine, how long her side effects from the covid vaccine will last and asking for suggestions on how to get rid of the side effects from the covid vaccine. The outcome of event vaccination site pain was recovered in Feb2021 (duration of event was 2 days), swelling under her eyes, face was swollen was not recovered while outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.

Blood clot caused stroke on right side of the body 4 weeks after the 2nd dose of vaccination; Blood clot caused stroke on right side of the body 4 weeks after the 2nd dose of vaccination; The patient also received the first dose of other vaccine on 18Apr2021.; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 76 years old, in left arm on 18Apr2021 14:30 at single dose for covid-19 immunisation. Medical history included high blood pressure. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination. The patient received high blood pressure medicine within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient previously received the first dose of BNT162B2 (lot number: unknown), at the age of 76 years old, in left arm on 28Mar2021 14:30 at single dose for covid-19 immunisation. The patient also received the first dose of other vaccine on 18Apr2021. The patient experienced blood clot caused stroke on right side of the body 4 weeks after the second dose of vaccination on 15May2021 20:00. The patient was hospitalized for the events blood clot caused stroke on right side of the body for 14 days. The events blood clot caused stroke on right side of the body caused disability. The patient had not been tested for covid-19 since the vaccination. Therapeutic measures were taken as a result of blood clot caused stroke on right side of the body 4 weeks and included treatment with tissue plasminogen activator (TPA) shot, magnetic resonance imaging (MRI) and therapy. The outcome of events blood clot caused stroke was recovering. The outcome of event received other vaccine on 18Apr2021 was unknown. Information on the batch/lot number has been requested.

Acute idiopathic Pericarditis with recent hx of new onset rapid atrial fib admitted from 5/18-5/21 thought to be a possible immune mediated side effect from her covid 19 vaccine .. since 5/9 she has been experiencing daily severe headaches, malaise, intermittent palpitations. Ct brain at that time neg for bleed but showed small/old b/l lacunar infarcts. cta was neg for pe/acute pathology. She was discharged out on amiodarone, metoprolol and eliquiss to follow up with cardiology.on follow up with him her amiodarone was dc'd and the plan was to see EP for possible cardioversion but She then was readmitted from 6/5 -6/8 with new pericardititis with new b/l pleural effusions, new chf and new cardiomyopathy. She c/o 2 days of sob, b/l shoulder pain, chest heaviness and pain, worsened while lying flat along with continued intermittent racing heart. cxr showed new Basilar predominant opacities in both lungs suggesting pulmonary edema and was admitted with new chf with bnp of 993. She was then noted to have an elevated wbc with left shift and a fever and her CRP was markedly elevated at 67. CT chest showing Nonspecific abnormalities including 1cm thick pericardial effusion, bilateral pleural effusions and mild right-sided ground-glass lung opacification. . She has had no recent infections, travel, cont meds, does not drink alcohol, smoke or use drugs or supplements covid 19 neg. She was started on colchicine 0.6mg bid and ibuprofen 600mg q8h on 6/6 and was discharged home to follow up again with cardiology. she has improvement in herwbc to normal, resolution of L shift, resolution of fever and only slight increased crp. She has also converted to sinus rhythm although still tachycardic around 110bpm. Her headache is gone and she is no longer vomiting. State echo done this am showing ef 55% and new hypokinesis of the basal inferior wall and a Small amount of pericardial effusion with out any doppler evidence of Tamponade She had an echo last month which was normal She was also started on antibiotics due to b/l effusions which were eventually stopped before discharge

Heart pounding, palpitations day 3-4. Decreased hearing after shot #2 given on 03/29/2021. Increased joint pain in right hip after second shot. Noticed pain increase about first week of May, 2021.

A few days after I got the shot I started having night sweats, nausea. The night sweats went away until I got my second vaccine. Now I have them every night. They are not as bad. My doctor put me on medicine. I have fluid around my heart. Pericardial effusion is what I was diagnosed with. I also have small cell vasculitis. My red blood cell dropped.

5 days later went to ER with severe chest pain. Determined it was a heart attack due to blood clot. Was in the hospital for 2 days. EKG, catheter to heart, cat scan, blood tests

Major nosebleed; Headache; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient reported for herself). A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown, Expiration Date: unknown), via an unspecified route of administered in Arm Left on 03Jun2021 08:00 (at the age of 46-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus Verbatim: Diabetic (She takes medication.Caller stated she probably was diagnosed 25 years ago. It's been a while), allergy (she took the shot because of her allergies), peripheral swelling (Her arm swelled up 3 times), compromised immune status, respiratory illness, genetic, chromosomal abnormalities, Endocrine abnormalities (endocrine abnormalities, including diabetes and obesity) from an unknown date and unknown if ongoing verbatim. The patient concomitant medications were not reported. The patient previously took epinephrine and experienced drug hypersensitivity. smallpox vaccine, vaccination Date: 1969. Her daughter was getting her smallpox vaccination at the same time. The caller had never had a smallpox vaccination. They decided to give it to her and her daughter at the same time. Her arm swelled all up again to the point her daughter took her to the emergency room. patient took Tetanus vaccine in 1996 and experienced allergy to vaccine, they told the caller she was allergic to the tetanus. She now wears a bracelet. Hopefully no one will give her a tetanus shot. Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. Caller stated she probably was diagnosed 25 years ago. Caller stated she does take diabetic medication. Vaccination Facility Type caller stated the clinic is connected to the hospital. No additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reporter stated, She had her first shot. She was advised to be near a hospital when she took the shot because of her allergic to the Epinephrine. she took the shot there. On 03Jun2021, patient experienced headache. she didn't had a headache before the shot. By noon, she was felt this headache. Caller stated she still has a little bit of it right above her left eye. the headache didn't go away with the Tylenol. The Tylenol doesn't seem to help much. She had to go buy some Tylenol. She had a major nosebleed on 05Jun2021 14:35 Saturday. Her headache kept getting worse. Reporter stated she did go to the physician office to get the packing removed from her nose. She went to the Emergency Room on Saturday. They had to cauterize her nose and packed it. She had no idea if it was from the shot or if the shot contributed to it. She hasn't had a nosebleed like that in years. It has been a long time since she had a bad nosebleed. She just wanted to let Pfizer know what's going on with her because it may help someone else. Her daughter was in healthcare and said caller should call and let Pfizer know. What good was it going to do to continue with the report. Reporter stated she still has a little bit headache on right above her left eye. It's not quite as bad as it was. It's there. She can tell it's there. Reporter stated she has no idea about dose. Caller stated she was not hospitalized. The outcome of the event major nosebleed was reported as recovered on 08Jun2021 and the headache was recovering. Description of complaint: Caller was reporting an AE to the Pfizer Covid Shot. Caller reports taking Tylenol for a headache and the headache did not go away. Caller reports the Tylenol doesn't seem to help much. Product strength and count size dispensed: Caller confirmed that it is 500 mg of Acetaminophen. She only took 2 like the instructions tell you. Count size is 60 tablets in the bottle. Packaging sealed and intact: absolutely. Information on the lot/batch number has been requested.

Patient presented to the ED and was subsequently hospitalized for heart failure within 6 weeks of receiving COVID vaccination.

Stroke. MRI shows small blood clot. in lower back of brain leaving a small blank spot in my vision in upper right

secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse 46 , cyanotic lips, limp, resps 11. pt passed at 2:30

About a week after the vaccine, I started to notice a subtle difference in my heart beat. At night, I could feel my heart beat was a little off. I went to the doctor for something unrelated and was place on EKG that's how the doctor detected my arrythmia. He said I had A-fib and sent me to the ER. The ER confirmed my A-fib with an EKG and prescribed Eliquis, furosemide and potassium. A few days after discharge, I had chest heaviness and couldn't breath. I went to the ER. They did an EKG, CAT scan, blood work which also confirmed A-fib and build up of fluid around my heart, lungs and abdomen. I followed up with a cardiologist office and was to continue with the medications at discharge. I am being followed with a cardiolgist. Since then, my heart rythm is back to normal from what I can tell.

Stumbled and broke her right arm in 3 places; Stumbled and broke her right arm in 3 places; Got a big chip in her hip; Chipped the acetabulum on her pelvis, there is a big chip on that, but it did stay in place, so no surgery is needed; Precipitous drop in energy level; Fuzzy mentally; Acute lethargy; A little arm soreness; Low blood pressure; She wasn't feeling well; In a lot of pain with the chip in her hip; Fell on her right side and it was in her house, of course, on her tile floor; Low cholesterol; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206; Expiration date was not reported) on the right deltoid on 11Mar2021 (09:45) as a 2nd dose, single, with route of administration unspecified, for COVID-19 immunization at the clinic (not in a military facility). Medical history included ongoing hypothyroidism diagnosed probably 10 years ago. Concomitant medication included levothyroxine for hypothyroidism. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on 17Feb2021 on the left deltoid for COVID-19 immunization. On 12Mar2021, the patient had a little arm soreness. On 13Mar2021, the patient had precipitous drop in energy level (50% drop in energy her level; then 30% down at the time of reporting); was fuzzy mentally enough that her friends event noticed it; and had acute lethargy. On 20Mar2021, the patient had stumbled, and right arm x-ray AC and lateral showed she broke her right arm in three places; got a big chip in her hip; and right hip x-ray showed she had chipped the acetabulum on her pelvis (there was a big chip on that), but it did stay in place, so no surgery was needed. The patient had a surgery on the right arm, and had to have a 4-hour surgery to replace the Olecranon where it should have been, and a plate and a couple of screws. The events, 'stumbled and broke her right arm in three places', 'got a big chip in her hip' and 'chipped the acetabulum on her pelvis', were assessed as serious (medically significant). On an unspecified date in 2021, the patient had low blood pressure (110/60); was not feeling well due to the second dose of vaccination; was in a lot of pain with the chip in her hip; fell on her right side and it was in her house, of course, on her tile floor; and had low cholesterol. The reported events had resulted into an emergency room visit and physician's office visit (orthopedics). The outcome of the events was recovering for 'stumbled and broke her right arm in three places', 'precipitous drop in energy level', 'fuzzy mentally' and 'acute lethargy'; was not recovered for 'got a big chip in her hip'; was recovered on 14Mar2021 for 'arm soreness'; and was unknown for all the other events. No follow-up attempts are possible. No further information is expected.

Pt call hospital call center on 5/26/21 c/o Shortness of breath, rapid heartbeat and weakness started 2 days ago. Patient stated received covid vaccine 2nd dose 5/22/2021 which she received at outside pharmacy. Pt advised to go to ED but she declined. ED education were reiterated to patient.

I had slight rise in blood pressure and pulse; I had slight rise in blood pressure and pulse; felt tired; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration, administered in Arm Right on 31Jan2021 16:00 as (At the age of 76-years) DOSE 1, SINGLE for COVID-19 immunisation. Medical history included blood pressure abnormal, patient Was on blood pressure medication for many years. After losing 20 pounds did not need it anymore, blood cholesterol abnormal from an unknown date and unknown if ongoing Take Crestor 10 mg for cholesterol (total around160). Patient had no Known allergies except latex band aids. Concomitant medication included vitamin d3 and rosuvastatin calcium (CRESTOR). Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination and post vaccination. It was reported that After the first shot patient had slight rise in blood pressure and pulse after about 5 days but otherwise just felt tired. As treatment patient received Benicar 40 mg and Lorazapam.5 mg, Zicam. The patient underwent lab tests and procedures which included blood pressure measurement: rise on Feb2021 slight rise in blood pressure and pulse, heart rate: rise on Feb2021 slight rise in blood pressure and pulse. On an unspecified date in 2021, the events was resolved with sequelae. No follow-up attempts are possible. No further information is expected.

RIGHT LEG SWELLING, PURPLE IN COLOR, ER VISIT REQUIRING DUPLEX SCAN WITH RESULT OF EXTENSIVE BLOOD CLOT DOWN ENTIRE LEG, 80 % BLOCKAGE. THREE DAY HOSPITAL STAY, INTERVENES TREATMENT OF HEPRIN

admitted with STEMI and acute hypoxic respiratory failure and severe cardiogenic shock requiring ICU vasopressor support.

Second dose: lymph nodes under jaw still swollen; Second dose: dizzy; Second dose: rapid heartbeat; Second dose: almost passed out; Second dose: throat tightened; Second dose: jaw was tender; Second dose: lymph nodes under jaw were tender; Second dose: jaw was tender/Second dose: lymph nodes under jaw were tender; Second dose: tired; Second dose: nauseous; Second dose: diarrhea; Second dose: muscle pain; Second dose: joint pain; Second dose: chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 30Jan2021 (76-years-old at the time of vaccination), (Batch/Lot Number: EL9265, Expiry date May2021) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection dose 1 via an unspecified route of administration, administered in Arm Right on 09Jan2021 12:30(76-years-old at the time of vaccination), (Batch/Lot Number: EL3248; Expiration Date: Apr2021) as DOSE 1, SINGLE for covid-19 immunisation and experienced throat started tightening, Lymph nodes under her jaw were sensitive to the touch, feeling more and more tired, entire body was leaden with lethargy, couldn't do anything, all her joints were aflame, nauseous, pain in muscles, pain in joints, couldn't raise either of her arms, chills, low grade fever of 99.2 degrees Fahrenheit, Fatigue. Patient was dreading getting the second Covid 19 vaccine. One of the questions on the questionnaire she filled out prior to getting her second dose was if she had a severe reaction to any vaccine. She answered yes but no one at the facility asked her about it. She put that she may have had a severe reaction with the first Covid 19 vaccine but no one at the facility questioned it. She put question marks on the questionnaire on that question to indicate she didn't know if she had a severe reaction for sure or not. She did want to have protection against the Covid 19 virus, so she did get the second Covid 19 vaccine. After getting the second Covid 19 vaccine she experienced the same thing going home. Her throat tightened. Her jaw and lymph nodes under her jaw were tender. She was tired but didn't feel the leaden feeling she had with the first Covid 19 vaccine. She was nauseous and had diarrhea. She had muscle pain and joint pain and chills. These symptoms went on for 5 days. She thought she would be ok after the 5 days like she was after her first Covid 19 vaccine dose. On the sixth day she almost passed out in the grocery store. She had to sit on the floor of the grocery store and put her head between her knees. She was dizzy. She was still having the diarrhea, nausea, and chills. It was like having influenza symptoms. She went home that day and got into bed. Then gradually she got better. Maybe around the 9th day after the vaccine she was able to do some things around her house and on the 10th day she was better. Her lymph nodes under her jaw were still swollen. She doesn't know if what she experienced were normal side effects. She found the Pfizer reporting website obtuse. The website indicates there was a time limit to finish a report. She did not file online because she wasn't sure she'd be able to finish in the time limit. She was grateful for protection against the Covid 19 virus and would get the Covid 19 vaccines all over again, but she was not looking forward to getting a Covid 19 vaccine booster. She reported she was very healthy and active. When probed if she had seen her primary care doctor or gone to the emergency department, she reports the hospital was far away. She was living in a rural area in the mountains and did not trust the closest hospital to her. Her doctor friend who was an ophthalmologist told her that her antibodies were really kicking in and that's why she had the reaction to the Covid 19 vaccine like she did. When probing adverse events following any other vaccines, she reports she hasn't had a vaccine since childhood and doesn't remember having any adverse events from her childhood vaccinations. The last vaccine she had prior to the Covid 19 vaccine was the cold vaccine she received in 1992. She'd like to add she also had a rapid heartbeat with the dizziness on the day she almost passed out in the grocery store. That was the sixth day after the second Covid 19 vaccine on 05Feb2021. Her heartbeat was rapid for about a week after starting on 05Feb2021. The clinical outcome of the events lymph nodes under jaw still swollen was not recovered, remaining all events was unknown. No Follow up attempts are possible: No Further information is excepted.

Atrium flutter Blurry right eye Shortness of breath July 4 2021 onset. Still in vestigating. Ruled out stroke, glaucoma, no retina damage. At ER on 5th

anxiety attack on Feb 5 and again on Feb 17...did not seek medical attention...took a baby aspirin and a half a muscle relaxer. both dissapated on their own. Had another much more serious attack June 15 with heart rate at 126...visited ER...they did ECG but after waiting in receiption for over an hour my heart rate and bp were back down within normal range. Have also been having "flushes" through my system like warm water is being put into my system...lasts seconds..sometimes increased heart rate other times not. June10-11 major spike in blood pressure. with 3 day hospital vist as a result. Now on BP meds.

PFIZER-BIONTECH COVID-19 EUA. PATIENT FULLY VACCINATED WITH PFIZER COVID-19 VACCINE. 7/19/21 4:19PM: TESTED POSTIVE FOR COVID-19. COUGH WITH CONGESTION NOTED. 02 SAT 97%. 7/20/21 10:57AM: O2 SAT 98%, AFEBRILE. NO COMPLAINTS. 7/20/21 8:30PM: PATIENT 02 sat 77% RA, SOB, non-prod cough, wheezes/crackles TO LUNG FIELDS. PLACED ON O2 @4L, O2 CAME UP TO 82%. PATIENT VERY LETHARGIC. AFEBRILE AT 98.4. NURSING FACILITY SENT TO ER.

Pt vaccinated on 12/23. PCP notified that SOB and fatigue getting worse on 1/4. Unable to keep pre-op Dental work planned prior to mitral valve surgery on 1/14/2021. PCP referred her to our ED where she was diagnosed with COVID-19 and transferred to facility, which is where her surgery was planned.

Facial drooping on 1/4/2021 6 days after the vaccine suffered a mild TIA or bells palsy event. appointments for a CT scan. Has mild facial drooping on the side that is already affected by TIA / cerebral hemorrhage. The long-term or permanent outcome is unknown.

Complaints of dizziness and weakness resulting in a fall with injury, hypoxia (resulting in initiation of supplemental oxygen continuous since 1-16-2021),acute hypotension, elevated heart rate, complaints of feeling unwell, increased confusion.

10:00am done with shot, 1/2 hour observation, 10 to 15 minutes later driving home felt need to have a BM, arriving home had diarrhea then tremors of both hands, fast heart, and extreme tiredness

admitted to hospital on 21 Jan 21 with Acute cystitis without hematuria; Cardiovascular disease; Diarrhea; ST segment depression; Syncope, unspecified syncope type Discharged on 26 Jan 21

High blood sugars for 24 hours even with two additional doses foyr hours apart by injection of 10 units of Novolog Aspart insulin

Very Soar Arm and tired first day. Second day, Soar Throat when swallowing, Swollen Eyes in the morning when I woke up, increased blood pressure at times and not as stable when walking. Very Tired. Took Benedryl on second day, one in morning and one at night. Seemed to calm symptoms. Soar Throat lasted two days and much better today (day 3). Left Arm also less soar today and stability when walking seems better...

Palpitation, shaking, weakness, sudden onset on 1/27/21 at 8:00am. Was seen in the ED and found to be in sinus tachycardia; resolved without intervention.

Hypertensive urgency and acute CHF exacerbation with hypoxia. Hospitalized for diuresis with furosemide. Currently much improved and discharged home. Symptoms started night of 1/22/2021. Worsened 1/25. Went to urgent care 1/26 and sent to hospital where she was admitted 1/26-28. Patient diagnosed with COVID-19 and was hospitalized for acute respiratory failure not requiring intubation in Jun 2020.

10:55 "I feel a little woozy" HR - irregular; dry; "feelin' a little nauseated" Neuro - intact; monitoring sats & b/p. 1103 - Nausea - gone! good V/S. Stayed with patient, V/S equalized and pt slowly got better.

Persistent headache followed 12 hrs later by mild dizziness, nausea, feeling vaguely ?off, now in 4th day. BP slightly elevated this morning 138/80.

Itching/She was itching on her knee, leg, arm, neck, and ears.; She had hives on the knee; The two that had her most worried was the memory loss and chest pain; Chest pain; It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street; Spasms/spasms were like in her back where her shoulders were and it was bulging; It hurt from her neck and up into her head.; It hurt from her neck and up into her head.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3246, expiration date unspecified), via an unspecified route of administration on 10Jan2021 (around noon) at single dose (left arm) for COVID-19 immunization. Medical history included ongoing diabetes, ongoing blood pressure high/blood pressure, ongoing heart problems; heart disease, kidney disease, history of itching, fluid (imbalance), stroke so taking for clotting, history of neck issues and she was allergic to a lot of medications. Ongoing concomitant medications included ubidecarenone (COQ-10), zinc, torsemide for fluid, clopidogrel for had a stroke so taking for clotting, insulin glargine (LANTUS) for diabetes and isosorbide mononitrate, carvedilol, irbesartan and amlodipine, all for blood pressure. Patient reported that she got the injection on Sunday and then later she started to get spasms on 12Jan2021. These spasms were like in her back where her shoulders were and it was bulging and it hurt from her neck and up into her head. She mentioned she was 77 years old and sometimes she has to think about a word before she gets it out, but yesterday (14Jan2021) it was different. It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street on and this lasted 15 minutes and then it went away. She confirmed she does not have it right now. It did not last a long time, but it scared her so bad. Then yesterday evening (14Jan2021), she started to have funny chest pain. She told her husband if it did not go away she would go to the ER. However, after an 1 hour it went away. It was like a sticking pain. The chest pain lasted for an hour and started around 18:00. On an unspecified date, she started itching at night. She has a history of itching, but this was out the box. She had hives on the knee. It was crazy. She itched all over. She had to get out of bed and sit in a chair until 1:30AM. She was still itching, but it was not as bad. Patient reported that due to the kidney disease she has itching, but the itching she was having after this COVID Vaccine was different and more. It was out of the box. She confirmed this was the first injection and now she was scared to get the second injection. Patient reported that the itching started when she went to bed. She went to bed around 21:00 and around 21:30, she got out of bed because she was itching so bad. She stated there was not anything different on the bed. It was the same thing that was up there the night before. She did not change the sheets or anything. She had to get up and sit in a chair and she could not believe how bad her knee was itching. She was itching on her knee, leg, arm, neck, and ears. She stated she takes a lot of medications. She was very funny with medications and they have to work with her to get the right one for her. Due to having these other conditions was why she wanted to get the COVID Vaccine. She reported she will have her blood drawn next week. The two that had her most worried was the memory loss and chest pain. However, these passed and she did not go the ER or physician office. She was afraid if she gets the second injection this will happen again and she may not come out as well form it. Prior vaccinations within 4 weeks was none. Outcome of events spasms/spasms were like in her back where her shoulders were and it was bulging and itching/itching on her knee, leg, arm, neck, and ears was recovering; chest pain was recovered on 14Jan2021 at 19:00; and outcome of the rest of events was unknown.

she did not feel totally right; some high blood pressure; she has an irregular heart beat; This is a spontaneous report from a contactable consumer (patient). The 77-years-old female patient received first dose of BNT162b2 (BNT162B2, lot number: EL3248), via an unspecified route of administration on 18Jan2021at SINGLE DOSE for covid-19 immunisation. Medical history included diagnosis of irregular heart rate prior to the vaccine, about 4-5 years ago, allergy, Cholesterol. The patient experienced some high blood pressure on Jan2021, she has an irregular heart beat on Jan2021. "I developed some high blood pressure after getting the vaccine." she has developed a very high blood pressure reading and that is unusual for her, states she went to a walk in clinic on Tuesday and then to the doctor today. Caller states that it really concerns her that someone who is medically savvy as she could have a serious problem. stated that she did not feel totally right while she was waiting afterwards, states that she came home and laid around and the next morning, she can tell when it is high because she is chronically low. Caller states the next morning the top number of her blood pressure was 166, states bottom number is never out of sync (AS REPORTED). Caller states she could feel it really bad yesterday, really bad states she took the pressure once and it was 182/94 and a little later it was 192/84 and that is when she went to the walk in clinic. Caller states she has an irregular heart beat and she takes a blood pressure medication to treat that, takes 25mg once a day at night time. Yesterday morning she took another one before she went to the walk in clinic to help treat the high blood pressure, so she had 50 mg in 12 hours; when she got there they checked it and it was 178/72. She also takes an allergy medication and something for cholesterol that she has been taking for years. She called on 21Jan2021 around 5pm regarding the Pfizer covid vaccine. She called because she was having blood pressure issues and two different doctors thought it was covid vaccine related. It has taken since then till today to get a reasonable blood pressure. Her thoughts are not to get the second dose. She is asking if she will have any protection if she does not get the vaccine and if there will be any adverse effects if she goes not get the second vaccine. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.

Within 15-minutes of vaccination, the patient reported feeling short of breath and lightheaded. Patient stated this was a regular occurrence and that it happens multiple times a week. Patient also attributed it to her anxiety. Patient was hypertensive (180/88), A&Ox4 with GCS15. Patient sat down to catch her breath and stated improvement. Patient refused transport.

Patient complained of dizziness and said she was going to pass out. Observation nurse called site clinical lead over, at that time the patient was responding to verbal cues. Mask was taken down and she was guided to take slow deep breaths, continued to report feeling as though she was going to pass out. Site clinical lead then noted patient with fixed gaze to the size, clenching hands and rigid posture. Observation nurse called for EMS assistance. Patient breathing slowed, mouth open, eyes remain fixed to the size with rigid posture for 5-10 seconds. Patient did not respond to any verbal cues. Site clinical lead and observation nurse lowered patient to the floor, at which point patient became responsive. Responded correctly to reason for visit to site, location and how she was feeling. Denied history of seizures or stroke. Reported feeling anxious and needing to use the bathroom. Did not appear to lose bowel control at any point. Patient was very diaphoretic and pale, but alert overall. Cold compresses applied to forehead and back of neck while patient remained supine. EMS arrived and had patient sit up, at which point she again became very pale and reported feeling as through she was going to pass out. EMS transported to hospital for further evaluation.

Increase in cardiac arrhythmia - a-fib and rapid pulse, up to 135bpm while asleep Muscle and joint pain Fatigue

Pt reported that she had a Pfizer vaccine on 2/7 at 10am and went home and experienced chest pain at 1pm that lasted for only a few seconds. Pt also experienced a mild SOB while walking in the hallway. Mild SOB was only lasted for a few secs (prior to chest pain). Pt stopped and rested and Pt felt fine afterwards. Chest pain Hx: Upon assessment, Pt also reported that pt experienced chest pain x1 (6 months ago) which also lasted for a few seconds. But, pt never reported this to pt's physician. Other Sxs: Symptoms: Headache. Onset: 2/8 AM. Pt took Tylenol 1000mg this 9am. Pt states she usually takes QAM for her arthritis. Effect: "It did not help." Pt denies any change in vision, blurry vision, double vision. Denies NV. Pt denies any chest pain or SOB today. Pt was able to speak clearly in full sentences. Pt was able to do ADLs without this morning. Pt stated, " I am able to carry on all my chores without difficulties. Other than headache I feel completely fine." No distress noted that needed an emergent care. Recommendation -Pt denies any significant related symptoms such as ?worst headache of life? or changes in vision, speech, or coordination, or nausea/vomiting. -Instructed to take analgesics such as Acetaminophen after 4-6 hrs (Adult dose: DO NOT EXCEED 4,000mg per day unless directed by the doctor) according to package instructions provided there are no contraindications. -Advised to rest and increase water intake. Education: -If pt experiences any chest pain, SOB, visual changes, change in mental status, N/V or ?worst headache of life?, pt was advised to go the nearest ED. -If headache is severe, focal, progressive or persists > 1 day: Pt was advised to reach out to PCP same day.???If PCP is not available should seek care at Urgent Care. Pt verbalized understanding and agreed with the plan.

diabetic; sugar level went to 66; shaking; dizziness; fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 77-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK9231), via an unspecified route of administration, on 23Jan2021 at 13:15, at single dose, for COVID-19 immunisation. Medical history included drug allergy (to epinephrine), diabetes, chronic obstructive pulmonary disease (COPD), arthritis. Patient did not have COVID-19 prior to vaccination. Concomitant medications included glipizide (unknown manufacturer), losartan (unknown manufacturer), lovastatin (unknown manufacturer), metformin hydrochloride (MEDFORMIN), meloxicam (unknown manufacturer). The patient experienced diabetic, sugar level went to 66, shaking, dizziness and fatigue all on 24Jan2021 at 11:00 with outcome of not recovered. The patient underwent lab tests and procedures which included blood glucose: 66 on 24Jan2021, 88 on 24Jan2021, 360 on 24Jan2021, 186 on 25Jan2021. On 24Jan2021 it was reported that sugar level went to 66. She ate sugar, level went to 88, ate more sugar level went to 360. Therapeutic measures were taken as a result of diabetic and sugar level went to 66 and included sugar. No therapeutic measures were taken as a result of the other events. Patient was not tested for COVID-19 post vaccination. The information on the lot/batch number has been requested.

"I started to feel strange". "Funny taste in mouth, dizziness, difficulty swallowing, and not thinking clearly, history of reaction to high dose flu shot, HTN

My blood pressure was a little elevated, high for me / elevated blood pressure; Arm sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FL3246, expiry date not reported), via an unspecified route of administration in the left arm on 23Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing thyroid disorder. Concomitant medication included hctz. The patient experienced that her blood pressure was a little elevated, high for her/elevated blood pressure on an unspecified date. On 25Jan2021, the patient experienced arm sore. The patient underwent lab tests and procedures which included blood pressure measurement: 160/88 on an unspecified date, blood pressure measurement: normal (reported as normally around 130, 135, 138, normally runs 140/35-38), heart rate: 85 on an unspecified date, laboratory test: unknown result on an unspecified date. Clinical outcome of arm sore was recovering, while for blood pressure increased was unknown.

HR at 11:30 and it was 104; This is a spontaneous report from a contactable consumer (reported for herself). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 26Jan2021 10:00 at a single dose in the right arm for COVID-19 immunization. Medical history included Afib (atrial fibrillation) from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination and reporting. Concomitant medications included apixaban (5 mg tab) at 5 mg, and atorvastatin calcium (10 mg tab) at 10 mg; both reported as other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient checked her HR (heart rate) at 11:30 and it was 104, and at 12:30 it had come down to 90. No treatments received in response to the event reported. The event was reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event "HR at 11:30 and it was 104" was recovering. Information on the lot/batch number has been requested.

dont want to eat anything; hot and cold chills; headaches; muscle pain; fever; joint pain; injection site swelling; redness; nauseated; swollen lymph nodes on throat; face swelling; fast heartbeat; body didn't feel well; chills; didn't feel like herself; light headed; felt weak; tired/slept all day; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 22Jan2021 15:30 at a single dose on right arm for COVID-19 immunization. Medical history included breast cancer 16 years ago, patient on defibrillator from Oct2016 (it was reported that this past October2020 would have been 4 years since she had the defibrillator put in), ongoing congestive heart failure, ongoing (COPD) chronic obstructive pulmonary disease, sinuses problems, back and hip problems, positive for COVID-19 from 11Jan2021, and hurting. The patient's concomitant medications were not reported. The patient previously received flu shot for immunization on unspecified date. On Saturday (23Jan2021), the patient reported that she "slept all day, felt weak, light-headed, and tired". The patient stated, "I have problems breathing anyways". The patient stated she "doesn't want to eat anything". On Sunday (24Jan2021), the patient "felt good", then Monday (25Jan2021), "didn't feel too bad". On unspecified date, patient experienced hot and cold chills, body didn't feel well, and breathing problems. She has breathing problems because she has COPD. Other things in the list of the adverse events (from the paperwork she was given) that the patient experienced include tiredness, headaches, muscle pain, chills, fever, joint pain, injection site swelling, redness, nauseated, feeling unwell, swollen lymph nodes on throat, face swelling, a fast heartbeat, dizziness, and weakness. Right now (26Jan2021), the patient did not even feel like going to her doctor's appointment (on Thursday). She just didn't feel like doing anything. She didn't feel like herself on 26Jan2021. She clarified on 11Jan2021 (prior to vaccination), she went to hospital because she was hurting. She clarified it was in and out of the Emergency Room. She was never admitted into the hospital. They ran some tests urine, blood, EKG tests. All the tests came back good. The patient underwent COVID test on 11Jan2021: positive; and same test on 22Jan2021: negative. Outcome of the events was unknown. Information about lot/batch number has been requested.

During being observed patient stated to medic that her heart was beating fast and is having body flashes. Patient taken to medic station. EKG and vital signs were done which showed within normal range. Patient observed and released in 30 minutes.

Bleeding on the toe of foot. Complete sock from ball of foot to end of ties was soaked with blood. This was a spot that Would bleed when I had IV chemo therapy in 2012. Called Dr. And HHT. Clinic at Hospital

RECEIVED BOTH DOSES OF PFIZER VACCINE. (01/23/21 & 02/13/21) AFTER 1 DAY (02/14/21) WENT TO ICC REPORTING SUDDEN HEARING LOSS IN RT EAR, LIGHT-HEADEDNESS, AND FEELING UNBALANCED. DIAGNOSED WITH HEARING LOSS OF RT EAR AND HYPERTENSION AND INSTRUCTED TO GO TO ER. WENT ER ON 02/14/21 AND WAS DIAGNOSED WITH ACUTE HEARING LOSS OF RT EAR.

Covid dose #2 (Lot EN6201) given at 1:19pm. Pt began feeling flushed, hot, and weak at approximately 1:30pm. She was able to walk into Triage under her own power. BP was 190s/90s upon arrival to traige. Pt pale and complained of feeling lightheaded and that she felt like she was going to pass out. 400ml of orange juice given since patient stated that she had not eaten since 8am. Blood sugar taken 15 minutes after resulted at 116. Multiple blood pressures taken resulted in consistent 190s/90s. 911 called by provider at 2:07pm. Fire Department arrived on scene at 2:13pm. EMS arrived on scene at 2:16pm. Vitals taken by EMS and it was determined that since her blood pressure continued to be elevated similar as prior and she felt unable to stand under her own power to take her to Emergency Department. EMS left the clinic at 2:30pm. Pt had all belonging with her and her family had been notified. She remained conscious and able to answer questions throughout the event.

Pt. recieved COVID vaccine on 4 Feb and came to hospital on 5 Feb with Chest pain; Elevated troponin; Exertional chest pain; Symptomatic bradycardia. Admitted for ACS and being treated with heparin. syncopal eisode. she was discharged on 9 Feb. Home course unknown

Patient face was flush. Noticed by family after the 15 min observation. Pt had no DIB or other complaints. Pts BP was high and has a history of hypertension. Unknown if this was caused by the vaccine or the patients preexisting health conditions. Pt was transported to hospital by ambulance.

RECEIVED PFIZER COVID-19 VACCINE 1ST DOSE ON 02/20/21. REPORTED TO ER ON 02/21/21 WITH COMPLAINTS OF ABDOMINAL PAIN AND NAUSEA AND VOMITING. DAIGNOSED WITH EPIGASTRIC ABDOMINAL PAIN, ATYPICAL CHEST PAIN, URINARY TRACT INFECTION WITH OUT HEMATURIA, AND HIATAL HERNIA. DISCHARGED HOME WITH INSTRUCTIONS FOR FOLLOW UP APPOINTMNET WITH PCP, GI, GENERAL SURGERY, AND CARDIOLOGY.

patient c/o lightheadness at 11:55am. Blood pressure was 142/90. Consulted with Doctor. observed for 10 more minutes. Patient started c/o numbness in face, shortness of breath and chest pain around 12:05pm. 02 was 99%. Consulted with Doctor and paramedics called. Patient was confused and had difficulty with balance while being transferred to ambulance. Transported to medical Center at 12:18pm

Experienced bad taste in my mouth right away, lips felt weird, breathing very raspy, chills, itching on head, ears, arms, headache, swallowing issues, stuffy nose, sinus pressure, extreme fatigue, dry mouth (felt like cotton in my mouth), temperature dropped. Took about five days to feel okay. Took Benadryl (took twice with six hours between doses, took antihistmine, Levocetiriine, used pro air quite often, 20 mg of Prednisone at 2:30 am on the 22 and finally felt relief. Dr.. was informed after I got better.

the patient had hypoxemia the evening of the shot, and then was found unresponsive the next morning, in cardiac arrest at home. Temperature on arrival to ED was 91 degrees. found to have severe anoxic brain injury after 60+ minutes of CPR. may already be brain dead.

2/19/21 12:30 AM- slight headache, followed by chills and body ache-especially lower bac. Last until about 4 PM 2/19/21 2/19/21 2:00 AM - discomfort chest/heart- Thought maybe I should mention it to doc if continued. Lasted 20 min. max. 2/19/21 12:30 AM-lower abdominal discomfort, bowel movement did not relieve discomfort - intermittent for several days until 2/23/21. Did not interfere with activities. Since symptoms were mild, I "toughed" it out. No medication

At 15 Minutes: Dizzy, felt like head exploded, heart pounding, BP over 200 for a short time, taken to a room for observation, after about 30 minutes taken to Prompt Care Facility on premesis. Had slight nausea, shakiness, weakness, little dizzy, headache. Treatment: observation, asking questions, checking vital signs, checked Glucose: Normal. Stayed at Clinic approx. 1 Hour. Considered going to ER but continued to feel better as time passed and went home. BP was at 167/66 when leaving. Later same evening 10:30 p.m. at home: BP at 136/72/66, Next day 2/21/2021 BP at 128/70/63. 2/22/2021 BP 123/66/61. Continue to have headaches.

Cardiogenic shock occurred on 2/10/2021, approximately 12 hours after patient received her 12th dose of pemetrexed/pembrolizumab and 4 days after COVID vaccine. Coronary angiography was done on 2/10/2021 and no significant coronary narrowing or blockage were noted. Baseline troponin on 2/10/21 was 0.02 and later on 2/10/21, troponins were 9.99 & 25.27. Creatinine increase from 1.2 to 3.4 within 24hours, and AST/ALT increased from 23 & 31 to 4,220 & 4,786 respectively on 2/11. Patient expired on 02/11/2021.

Felt jumpy on the injection site/right arm started jumping/"been jumping, jumpin jumpin jumpin", a muscle twitch; Felt jumpy on the injection site/right arm started jumping/"been jumping, jumpin jumpin jumpin", a muscle twitch; Arm is sore; Heart is pounding; I'm a little jittery. I am very nervous; I'm a little jittery. I am very nervous; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the right arm on 27Jan2021 (10:00) at a single dose for COVID-19 immunization at the school/student health clinic. Medical history included diabetes diagnosed about 12 years ago; high blood pressure diagnosed about 30 or 40 years ago; and weight loss. Concomitant medication included insulin (INSULIN) for diabetes. The patient previously took influenza vaccine, sitagliptin phosphate (JANUVIA) and tramadol (ZALDIAR); and had rash on both medications. The patient had previously received a flu shot around the 6th or 7th of Dec2020. On 27Jan2021, at "about 4PM", the patient had felt jumpy on the injection site/right arm started jumping; it had "been jumping, jumpin jumpin jumpin, a muscle twitch". Also on 27Jan2021, at "about 4PM", the patient's arm was sore; heart was pounding; was a little jittery; and was very nervous. The outcome of the events, 'felt jumpy on the injection site/right arm started jumping', 'had "been jumping, jumpin jumpin jumpin, a muscle twitch"', 'arm was sore', 'heart was pounding', 'little jittery' and 'very nervous', was unknown.

Client report having COVID in November 10, 2020. Client received first dose on 02/09/21 at 2 pm, reaction of SOB began two hours later. SOB progressed to chest pain and fatigue. She sat at kitchen table to relax and rest, fell asleep for 2 hours. When she woke up she continued to have trouble breathing, drank some warm tea, went to bed and slept for 12 hours. This is not usual for her sleep schedule. The next day she felt better for a couple of hours then had some difficulty breathing again. She went to Urgent Care. EKG and chest X-ray preformed came back normal. Blood pressure was elevated. Client given 4 puffs of an inhaler. Discharged to home.

patient c/o cotton mouth, felling like a tight airway. Breath sounds diminished bilaterally, expiratory wheezes. Vital signs 136/88-108 (irregular) O2 Sat 95% History of anaphylaxis . O2 sate decreased to 88% Epinephrine 0.3mg IM administered at 3:09pm. Pt states that feeling of tightness EMS notified and patient transported to hospital at 3:25pm

Back pain, bilateral lower extremity neuropathy, paresthesias, lower extremity weakness, urinary retention, orthostatic hypotension

Vaccinated with Pfizer COVID vaccine on 1/21/21 and 2/12/21. Unknown facility, lot number Hospital course 2/24 ? 2/26/21 2/24 Chief complaint: Chest Pain. Per EMS - CP and SOB started 1220. Mid CP radiating to left arm. semi-relief with nitro x 2. Reports N. Denies V and no other symptoms. Hx cardiac stents, MI. HPI: Patient is a 77-year-old female who presents to the ER for evaluation of chest pain. Patient states that her chest pain started this afternoon around 1230 when she was cooking lunch. She says it lasted for about 10 minutes and was a intense substernal chest pressure sensation with radiation down her left arm. She had associated shortness of breath and diaphoresis and also endorsed nausea without vomiting. Patient also states she is had some occasional dizziness which she described as a room spinning sensation is made worse when she is in positions and standing or moves her head. She has a history of 2 heart attacks and 2 stents placed which were done. She has no local cardiology follow-up and she lives at an apartment and follows with pace. EMS gave her 4 aspirin prior to arrival she takes no blood thinners but she does take Plavix. Patient has a history of COPD and also endorses some wheezing, she says they took her nebulizer away from her for fear of spreading coronavirus and she is oxygen dependent at nighttime. COVID positive 2/24/21 (this assay amplifies and detects The target rna using real-time pcr. Testing performed on cepheid genexpert) Patient states she tested negative for COVID 19 last week at her PCP and got her 2nd COVID 19 vaccine on 2/11/2021. She reports having dinner with a friend 3 weeks ago who just passed away from COVID 19. EKG shows normal sinus rhythm with incomplete right bundle branch block and no obvious ST segment elevations or acute ischemic intervals Troponin negative Patient admitted to the COVID unit. Home (baseline) O2 requirement 2.5L at night 2/25: 3L O2 nasal cannula continuously, reduced to 2L within 12 hours No fever COPD with acute exacerbation: Diffusely wheezing bilaterally and in tripod position on exam. Start IV Solu-Medrol COVID-19 viral infection: Start IV Remdesivir as she is now requiring supplemental oxygen. IV steroids as above. Chest pain, history of CAD with previous stenting --Denies any chest pain on exam. EKG negative for ischemic changes. Troponin negative x1. Continue to trend troponin x2 more occurrences. --Continue Aspirin, Plavix, statin, Imdur. Anxiety disorder: Continue Prozac. Add Xanax 0.25 mg 3 times daily as needed. 2/26: medically ready for discharge to SNF COVID unit. Augmentin 875/125 x 7 days dexamethasone 6mg daily x 8 days

she was hospitalized 2.5 days after having symptoms of a "massive heart attack" 2 days after the vaccine; blood clot; pain on the left side/pain so bad/ pain was so severe couldn't bent over and couldn't get up; pain was in the heart and underneath the rib; pain was in the heart and underneath the rib; had a little trouble breathing; broke out in a sweat; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date in Feb2021 at a single dose for COVID-19 immunization. Medical history included asthmatic, had double pneumonia years ago, has ongoing atrial fibrillation and a pacemaker to control it as the only problem she has in her heart. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient was hospitalized for 2.5 days after having symptoms of a massive heart attack two days after the vaccine. It was reported that two days post vaccination, the patient was rushed to the hospital by ambulance as they thought she was having a massive heart attack. She added her symptoms lasted for hours, she had pain so bad that she was bent over and had a little trouble breathing. She said the pain was in the heart and underneath the rib, on the left side. She later mentioned she did not feel like it was AFib. She said they did every test possible and listed the following ones: ultrasound, stress test, x-ray (unknown results), and blood work in Feb2021. She specified that her blood work indicated a blood clot. She mentioned she was told by her personal friend, who was a doctor, that by having the shot sometimes it indicated you have blood clots when you really don't. The patient also specified that she broke out in a sweat, the pain was so severe that she could not bend over and could not get up; therefore, they treated her as if she was having a massive heart attack for 12 hours at the hospital. It was reported that they kept giving her stuff to stop the effect with her heart. She mentioned her second dose was scheduled on 25Feb2021. She asked if her experience was reported as a side effect to the vaccine and should she get the second dose of the vaccine. She explained the doctors did not know what she had, and she needed to determine if she can receive the second dose. She also asked if we could notify her if a similar reaction is reported. The outcome of the events was unknown. Information on lot/batch number has been requested.

they gave her some IV because she was dehydrated; high blood pressure; felt like she was getting a migraine; she started getting dizzy; she has never had a hangover but it felt like she had a hangover; she didn't feel good; she was sick on her stomach; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3248), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. Patient received the first dose of the COVID vaccine and was experiencing high blood pressure on an unspecified date in Jan2021. Patient went to the ER and they told her something in the vaccine made it go up. Patient would like to know what in the vaccine would cause her blood pressure to go up and if any has experienced high blood pressure as a side effect of the vaccine. Patient reported that she didn't feel good, felt like she was getting a migraine and after that she started getting dizzy and she thought she was going to help herself and lay down on the bed for about 45 minutes and then she got up after that and walked around on Jan2021. She felt like, she has never had a hangover but it felt like she had a hangover, that was what it felt like, and she thought she hopes that doesn't last and she got up Wednesday morning (Jan2021) and went to her podiatrist appointment. She didn't feel good but she was okay so she went to the podiatrist and then later she was fixing supper and she had some grease in a pan that she fried something in and she thought she wanted to get some water in it so she went to go with the pan and she got to the door and took 3 steps back and she thought good Lord, there is something is wrong here. She did empty the water and the grease and she thought well it is going to have to stay there, it was right at the back door so anyway. Her son came home from work and she got him get the blood pressure cuff and take her pressure and it was 158/98 and she thought, this was not good. She said she will just go lay down for a while and she went on to bed. The patient was taken into the hospital via an ambulance. She sat there until about 4-5 hours and later they got to take her blood pressure and result was 189/92 on Jan2021. They gave her some IV because she was dehydrated and she got home, she lives about 30 miles form the hospital so they got home about 3 o'clock and next day she didn't feel good but she felt better. She confirmed she was not admitted to the hospital it was an ER visit and they sent her home. She felt Thursday was not a good day she came down off of what had her up. She was going to say no to the second dose because she was sick on her stomach and drunk as a dog, she was really dizzy, very dizzy and she just had to sit down quiet her self. She was supposed to have surgery but because of COVID it has been cancelled 3 times. The outcome of the events were unknown.

Have had benign PVCs in the past usually maybe 3 episodes a month. Four days after 2nd vaccine injection, I started to experience daily episodes 4 or 5 times per day in most cases; Have had benign PVCs in the past usually maybe 3 episodes a month. Four days after 2nd vaccine injection, I started to experience daily episodes 4 or 5 times per day in most cases; This is a spontaneous report from a contactable consumer who reported for herself, a 77-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 9262), via an unspecified route of administration in the left arm, on 09Feb2021 at 07:30, at the age of 77 years, at a single dose for COVID-19 immunization. Medical history included diabetes, spinal stenosis, and ongoing PVCs. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Concomitant medications included metformin, statin, and hydrochlorothiazide. The patient previously took codeine and had allergy; and received the first dose of BNT162B2 (Pfizer, Lot number: EL1284) on 19Jan2021 at 03:00 PM, at the age of 76 years, in the right arm, for COVID-19 immunization. It was reported that patient have had benign PVCs in the past - usually maybe 3 episodes a month. On 13Feb2021, reported as "four days after 2nd vaccine injection", patient started to experience daily episodes - 4 or 5 times per day in most cases. From day 4 to day 11, experiencing these episodes. On day 11 they started to subside. Patient was taking essential electrolytes and extra magnesium to help. The events were reported as non-serious. The outcome of the events was recovering.

Patient states she reacted immediately after receiving the vaccine. States that she felt dizzy & light headed, her BP went up to 163/90 and she had tingling in her feet "as if I were wearing tight compression socks". Medical record indicates that she called 911 the day after her vaccine & reported dizziness & slurred speech. She was told to go to the ER, but did not go. She reported to her PCP's office that she had arm itching, she was anxious & fatigued as well. She also reported that she "felt funny in the back of her throat" & seemed to be coughing more. Headache also reported.

Patient presented to ED with chief complaint of sudden onset dizziness, epigastric pain and generalized weakness, symptoms happened the day before yesterday, resolved, she noticed when she is trying to do any activities she gets heart fluttering. Epigastric pain noted in ED. Troponin Elevated, heparin IV started for possible NSTEMI. Patient is currently admitted.

It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; It was like a little twitch and then today it's like a jerk, it's big/Whole body is just jerking; Felt like I was going to pass out; Felt unwell; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6201), via an unspecified route of administration (at the age of 77-years-old) on 15Feb2021 at a single dose for COVID-19 immunization. Medical history included Diabetes, asthma, High blood pressure, fibromyalgia, cane user, Neuropathy. Concomitant medication included pregabalin (LYRICA) and unspecified medications ("No, I am not because it's a very long list and I don't feel good, I am jerking and I just don't feel like doing that I am sorry."). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Patient stated, "My experience with the COVID-19, I had the injection on 15Feb, the second one and I went back and sat in my chair and I was okay. And then I got up to leave and I felt like I was going to pass out (15Feb2021). So, I sat down in the chair, my husband asked for the nurse and she came and she thought it was my diabetes which I also sort of felt that, but anyway I came home and I felt unwell (15Feb2021), that afternoon and then the next day, I would feel like that and then the next day I had improved but I started with this jerking and that has been going now since then but today it's more like (incomplete sentence). At first, it was like small and now they are getting big like a jerk. I called my family doctor yesterday and I talked with the nurse and she told me that I needed to be checked within 4 hours. So, I went to one of the in and out you know places, emergency places that you can go to and she took a lot of blood, and ones that came back were okay but the other results, she is not going to get until tomorrow, I have to go back. But have you have anybody else that has had this experience?" The date when adverse event started was reported as "Started out, it was like a little twitch on Wednesday night that would have been from Monday to Wednesday and then today it's just like a jerk, it's big. My whole body is just jerking. I did not feel well the afternoon I had it. But the next day, I thought I was better and that is when the twitch started." The patient was experiencing event worse than ever. It's like a bigger jerk now. No treatment was received for the events. Lab test: "They took 5 vials of blood yesterday when I went to that doctor, and I heard for some of it, but for the rest, I will have the results tomorrow and I just had my blood drawn on Thursday from my kidney doctor. So, I have blood drawn all the time." The outcome of the event "felt like I was going to pass out" and felt unwell was recovering, and "it was like a little twitch and then today it's like a jerk, it's big/whole body is just jerking" was not recovered.

Progress Notes (Nurse Practitioner) ? ? Infusion Center Cosigned by: MD at 3/4/2021 8:28 AM Expand AllCollapse All COVID VACCINE CLINIC 3/2/2021 Subjective Patient is a 77 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience chest tightness and lightheadedness. She denied rash, glossal tightness or increased work of breathing This provider was notified of patient reaction and I was then assessed in the emergency bay area. PMH HTN, obesity and NIDDM. Cardiac cath 2 years ago: normal per report. Pt has NIDDM, ate eggs/baco this AM with AM FBS: 150 mg/mL. Pt has re-applied her long sleeve sweater and heavy coat as she began her observation period. She was alert, mild pallor with normal VS on arrival. Blood sugar: 80 mg/dL. Oxygen applied. BP138/62, HR76. Sat 100 % Granola bar/water provided with complete resolution of symptoms Monitored patient for severe reaction symptoms, including but not limited to any need for additional diagnostics. Recommendation for 30" observation period at Dose #2 of 2 . APRN-C Previous Reactions: none Objective Vitals There were no vitals filed for this visit. Blood Sugar 82 collected at 0953 Arrives in wheelchair, awake, alert HEENT: No glossal issues, no stridor LS CTA S1S2 Skin pale. No rash Anxious Assessment/Plan Treatment included: oxygen, blood glucose, VS monitoring, snack Follow up response to treatment: complete resolution of symptoms Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: hypoglycemic event APRN Electronically Signed 3/2/2021 9:52 AM

has not smell or taste a lot of the time; has not smell or taste a lot of the time; sight is not clear; flipped out; her blood pressure went up while she was in the Emergency room; panicked; Lightheadedness; Weakness; felt a little tired at that time; atrial fibrillation/started racing/Heartbeats irregular; anxiety; couldn't breathe/shortness of breath/hard time breathing; it was cold outside by her nephew's graveside, but she felt she had to fan herself like she was overheated; her heart rate was flying; scared; she said it was not a migraine headache like she is used to, but more of a mild headache; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EM9801), via an unspecified route of administration on the left arm, first dose on 04Feb2021 (Administered between 9:30-10:00AM) at single dose for COVID-19 immunisation. Medical history included chronic migraines all her life. She said her migraines have let up as she has gotten older. She also had an irregular heart rate before, saying her irregular heart rate started in her adult life. She said she considered herself more of a "carrier" for an irregular heart rate because her irregular heart rate doesn't happen enough for her to think about it. She said she doesn't have an irregular heart rate now. She said her father had a pacemaker & her 2 brothers had heart problems; her oldest brother passed away from his heart problems & her other brother has blood pressure issues. Patient also had mild asthma as an adult. She said she worked at (name) in a dusty environment, and lived near a landfill, where a lot of her neighbors have gotten sick. She said she needs an inhaler for her asthma. She said when she needs the inhaler, she takes 3-4 puffs at a time. She said she doesn't use the inhaler every day and also mentioned that her grandfather had died of a bad asthma attack. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on the same date of vaccine. No prior vaccinations within 4 weeks. There were no concomitant medications. On 13Feb2021, the patient experienced an atrial fibrillation in which she started racing and couldn't breathe. She mentioned that she recently attended a funeral but attributed the symptoms as side effects of the vaccine. She was taken to the Emergency room where she was given cortisone and resolved her symptoms. Patient also further reported she had side effects with the Pfizer COVID-19 Vaccine. She clarified she had her first COVID-19 Vaccine dose on 04Feb2021. She said her side effects happened less than 14 days after getting the COVID-19 Vaccine. Patient thought her side effects from the COVID-19 Vaccine may have been anxiety within. She said her nephew had died of COVID-19, and when she was at his funeral at the graveside, she flipped out while she was at her nephew's funeral, she was not doing good. She said she has a history of chronic migraines, and mild asthma. She said she had to lean against a gravestone because she couldn't breath. She said it was cold outside by her nephew's graveside, but she felt she had to fan herself like she was overheated. She said her heart rate was flying, and she had an irregular heart beat. She said she left her nephew's graveside and went to an urgent care. She said the doctor at the urgent care had done an EKG result abnormal, and told her she needed to go to the Emergency Room right away. She said the doctor had called the paramedics to transport her from the urgent care to the Emergency Room at (Institute name). She said she did not have any pain, but had a hard time breathing. She said she may have been scared because her grandfather had died of a bad asthma attack. She said she has chronic migraines, but what she had at the time was a mild headache, and not a migraine. She said she has not smell or taste a lot of the time. She clarified she has had no smell or taste for a while, saying she would not be able to tell if she got the COVID-19 Virus because of her loss of taste and smell. She said she was tested the Friday before her nephew's funeral and was negative for the COVID-19 Virus. She said she has had a total of four COVID-19 Virus tests before, and all her COVID-19 Virus tests have been negative. She clarified she did not have a COVID-19 Virus test while she was at the ER on Saturday, 13Feb2021. With her nephew's death, getting her COVID-19 Vaccine had left her mind. She said it didn't dawn on her until she settled down, and she thought her high heart rate and irregular heart beat were side effects of the COVID-19 Vaccine. She said she read the paperwork that was given to her at the time she got the COVID-19 Vaccine. She said the side effects listed for the COVID-19 Vaccine is what she had, a very fast heart beat, and it was very hard for her to breath. She said the Emergency Room doctor didn't think to ask her about the COVID-19 Vaccine. She said she panicked when she got to the hospital. She said she didn't even know that someone had drew blood from her. She said someone put a label on her, and told her the label was to show blood was drawn from her. She said when she looked down at the label, she saw an IV access was put in her arm. Additional treatment reported when she was in the Emergency Room, she was given an injection (clarified as IVPB on 13Feb2021) of Diltiazem 120mg at 12:13:50 PM, she said she was given another Diltiazem 5mg injection at the same time. She clarified she was diagnosed in the Emergency Room with Atrial Fibrillation. Patient stated that her blood pressure went up while she was in the Emergency room. She said she was kept in the Emergency Room so she could be monitored up until that evening. She said after the Diltiazem injections were given, her heart rate went down. She said the Emergency Room doctor gave her a prescription for Diltiazem 120mg white capsules, and told her to take the Diltiazem 120mg every day. She said the emergency room doctor told her she could go home, and that she needed to follow-up with her regular doctor. Reported she no longer has the shortness of breath, lightheadedness, or weakness. She said had felt a little tired at that time, as well. Patient also reported that on 22Feb2021 was her first day outside of her house since last Sunday (14Feb2021) and reported she has a slight headache, and her sight is not clear. She said she now feels she has "name" back, clarifying she has recovered completely. She has a follow up with her doctor on 24Feb2021. She is scheduled to take her 2nd dose on 04Mar2021 and is asking if she should take anything before the shot. Vaccination Facility Type was a pharmacy/drug store. Vaccine was not administered at Facility. The outcome of the events was recovered on an unspecified date.

ct reports having fever, body aches, stomach pain with nausea and diarrhea, palpations, rash on her face, vision problems

Was monitored for 30 mins and felt lightheaded and weak at the exit table. I was put in wheelchair, moved to a cot, and Paramedics were called. I was weak, couldn't stand without help and I felt drugged. I was taken to ER for monitoring and testing for reasons why this occurred. Continued to feel passed out for 2 hours. Tests for heart attack, diabetes and anemia were negative Diagnoses was Vasovagal attack - sent home after 8 hours monitoring

Have WPW with no complications until 03/12/2012 . I was taken to hospital after experiencing heavy chest and hard to breathe. I was released on 03/13/2021 after heart settled down. Only thing I can say is this episode came on quite differently than other episodes of WPW.

Approximately 2.5 days following my mothers fist covid-19 vaccine dose, she had a stroke and was admitted to the emergency room. She survived the stroke and following a brief stay at a skilled nursing facility, is still undergoing physical, occupational, and speech therapy.

weak feeling; heartbeat climb up and up; unnerving; This is a spontaneous report from a contactable consumer (patient). This 77-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318; expiration date 31May2021) via an unspecified route of administration on 05Feb2021 at 11:30 (at the age of 77-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included losartan, escitalopram, and atorvastatin from unknown dates for unspecified indications. The patient received dose 1 of BNT162B2 (lot number EL1284; left arm) on 15Jan2021 at 11:00. The patient previously received codeine on an unknown date for an unknown indication and experienced allergy. On 06Feb2021 at 13:00 the patient experienced a weak feeling and heartbeat climb up. The patient had a weak feeling, had to sit down and took her pulse with oximeter and her Apple watch. She watched her heartbeat climb up and up. She tried yoga breathing but could not slow it down. She was not sure how long this went on because it was very unnerving, but it reached as high as 105 before it started to go down. The beats went up, then down, finally started to keep going down. Once more there was a wave of the weakness through her before she stayed in the 73+ range. The patient was usually in the 60's. Since then the patient's heartbeats have been what is usual for her. During the episode the patient's husband found "rapid heartbeat" on the paper they received. The patient was concerned this happened a day after the vaccine, not within an hour. The events were reported as non-serious. The patient was not hospitalized and did not receive any treatment for the events. The outcomes of weak feeling and rapid heartbeat were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

dizziness; nausea; heart palpitations; fatigue 13 days; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (herself) reported that a 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number: EL9269) via an unspecified route of administration in left arm on 11Feb2021 14:00 at single dose for Covid-19 immunization. Medical history included Cholesterol, high blood pressure and history of ovarian and breast cancer. Concomitant medications included Pregabalin, rosuvastatin calcium (CRESTOR), fluoxetine hydrochloride (PROZAC) and amolodipine. Patient is good health had a bad reaction to the 1st COVID dose vaccine. Ended up in hospital emergency room on Friday 18Feb2021 with extreme dizziness and nausea and heart palpitations. Fatigue which had been going on since Friday 12Feb2021 14:30. Having had these reactions patient need to know from Pfizer is it safe for me to have second dose which is scheduled 04Mar2021. Seriousness was reported as non-serious. Patient did not receive treatment for events. No follow-up attempts are possible. No further information was provided.

6 hours of AFIB/taking a medication for AFIB and have not had AFIB for 3 years; 6 hours of AFIB/taking a medication for AFIB and have not had AFIB for 3 years; This is a spontaneous report from a non-contactable consumer (patient herself). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), via an unspecified route of administration on the left arm, on 26Feb2021 10:15, at a single dose, for covid-19 immunization. Medical history included allergies: bee stings and sulfa drugs, AFIB (not had AFIB for 3 years) and, had a confirmed case of COVID on Jan2021 (reported as 1 month before vaccination). Concomitant medication included unspecified medication for AFIB. The patient experienced 6 hours of AFIB on 27Feb2021 10:15, 24 hours after first dose. The patient was taking a medication for AFIB (concomitant medication) and have not had AFIB for 3 years. The patient recovered from the adverse event on 27Feb2021 16:15 with no treatment received for it. The patient was not covid-tested post-vaccination. No follow-up attempts are possible. No further information is expected.

sore at vaccination point; tightness and heaviness in chest about two hours following injection, lasted about two minutes.

3/11/2021 Patient presented with severe upper back muscle spasms and shortness of breath for the last 2 days. Diagnosed with pneumonia and hypoxia, confirmed by imaging. Covid test negative on admission.

1. I feel like I am going to fall, unstable gait with head pressure. 2. Generalized dizziness. 3. Scared and my heart races.

Lymph gland under left arm size of golf ball, smaller glands swollen underarm, (soft), neck swollen, left foot swollen, weakness, small blood clot in myopic of middle finger, small modules in upper thigh, sore on lower lip right side

One week post vaccine, caller's mother started to feel "phlegm-y", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14.

Within 30-minutes of vaccination, the patient reported feeling nauseous. The patient was reportedly hypertensive. No EMS report was filed. The patient did proceed to Emergency Department for follow-up. In the ED, the patient was hypertensive (153/69) and stated they continued to be nauseous. The physician administered 4mg IV Odansetron and 1L IV saline. Labs were unremarkable. The patient reported feeling improved after treatment and was discharged with a diagnosis of Side effect of vaccination.

Chills; aches and pains; chest spasms; a fever a little shy of 101; hard to breathe; feel ill; activated all that discomfort; she thought she was having a heart attack; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 20Jan2021 12:30 at single dose in right arm to prevent covid. Vaccination Facility Type was Health department. Medical history included rotator cuff challenge. There were no concomitant medications. No other vaccine was administered on the same date. There were no prior vaccinations within 4 weeks and no adverse events were following prior vaccinations. Patient was calling about Pfizer Covid vaccine. She had the first shot on 20Jan2021. She did not have a reaction. She went to go get her monthly massage on Saturday (23Jan2021). On Sunday morning (24Jan2021) she started to feel ill and she had to go the hospital. She confirmed she was not admitted to the hospital. She had chills, aches and pains, it felt like an elephant was on her chest, she had chest spasms, a fever a little shy of 101. She went to hospital and the doctor there told her she had covid since she had all the symptoms. She confirmed she did not have covid and had a negative covid test. She had chest x-ray and an EKG since she thought she was having a heart attack. Reported her massage was primarily on her left shoulder, it was a deep massage on that area since she had a rotator cuff challenge, massage was focused on that shoulder. She was thinking that the vaccine activated all that discomfort since she felt it from the left part of shoulder, went down to her chest like a v, and back up to her right shoulder. Every time she took a breath she had a chest spasm and it was hard to breathe. The events required a visit to emergency room. For treatment, they gave her medication to take called robaxin, it was an anti-spasm, and 800mg of ibuprofen. She took robaxin Sunday night, Monday, and she took one on Tuesday since she was feeling better. She was sensitive to medication. She felt dizzy and nausea from Robaxin. The patient had recovered from the events completely by Wednesday on 27Jan2021. She had a reminder to return for the second dose on 10Feb2021. She was asking if she should get the second dose. Information about Batch/Lot number has been requested.

On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body aches dry cough shortness of breath and subjective fevers as aggressive worsening since Friday. Patient received a 2nd dose of the pfizer COVID-19 vaccine on Friday 3/12/21 and states her symptoms worsened since then. Chest x-ray showed patchy bilateral infiltrates with concern for COVID pneumonia, also questionable vascular congestion as patient does have significant history of heart failure with pacemaker. EKG revealed paced rhythm 87 beats per minute. Emergency room patient was placed on BiPAP and responded well, patient was given vancomycin and cefepime for sepsis protocol.

Pt received the second dose of the Pfizer vaccine. The patient waited 15 minutes in the observation area. Once the patient left the building, her husband returned with her within 5 minutes of leaving bc, he noticed her having swelling of her left lower lip and itching in the throat with some difficulty breathing. She was attended to immediately by EMS, PA& physician at the site. Vitals were obtained: blood pressure was elevated at 220/110, PO2 96% pulse 115 BPM. A dose of 50 mg of benadryl was given to the patient orally. Within 10 minutes she felt improvement in her breathing and the swelling in her lip was not as prominent. BP remained elevated 200/100 , transported to hospital for further Tx & observation.

Fainted; lightheaded; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 23Feb2021 10:00 (lot number: EN6201) at the age of 77 years old, as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously took codeine and experienced allergies. The patient previously received first dose of bnt162b2 on 04Feb2021 for COVID-19 immunization (product: COVID 19, brand: Pfizer, lot number: EL9264, administration time: 09:45 AM, vaccine location: left arm). Next morning after vaccination (occurred on 24Feb2021 08:00), the patient felt lightheaded while bending over to empty dishwasher. The patient sat down on chair; and the patient's husband found the patient on floor, as she had fainted. The patient had no recall of fainting. No treatment was given for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 post vaccination. The patient did not receive other vaccines four weeks prior to COVID vaccine. The patient recovered from the events on unspecified date.

Within 5 minutes I became very light headed and weak. Also very hot and shaky. They had to put me into another room that was much cooler and put me into a recliner with feet up, ice behind my neck and on my forehead. I was pushing water so it was not dehydration, and I had eaten my normal healty breakfast also so not low blood sugar. This was my second shot and I had the same reaction with the first shot. It took about an hour before I could stand and walk again, but was still a bit shaky and faintly light headed for about another hour.

March 12, 2021 - On Friday about 2pm, I started with a runny nose ? by Sunday afternoon it was like a faucet turned on ? running down my face. March 13 - Saturday morning, I started coughing c chest congestion, and had Phlegm rattling in my chest, started sneezing very frequently/ some diarrhea. Otherwise, I felt fine. March 14 - Sunday morning, I started wheezing slightly, coughing more and sneezing frequently. Felt fine. Went shopping. Nose ran so much in store, had to run to the store to get paper towels to catch it. Later, when I carried a heavy bag of groceries from one car 12 feet to another, noticed I was very exhausted and had to rest about 15 minutes before driving home. Wheezing more. Monday, March 15, I took my B/P meds at 1:00am and my blood pressure was way up x 4 (160?s/ 70?s) p58-64, at 2:08am ? B/P was 183/92) so I took my PRN Clonidine and ate all the high Potassium foods I had in the house. By 3:40am my B/P was 120/66 but went back up later with coughing. I felt fine but tired. A little after 4am, I carried a bag of apples and a bag of oranges up my stairs and was totally exhausted ? I felt the energy draining out of me, and so was out of breath I dropped the bags on the floor and sat hyperventilating to get enough air in my lungs until I could breathe normally ? for 40 minutes - it felt like fluid building in my lungs. I started massaging my abdomen like crazy and coughing until it subsided ? considering whether I should go to E.R. My breathing did get some better But I sure did not exert myself. Just picking up my computer was taking my energy. Still coughing and getting rid of some phlegm. This was very scary and I was on the verge of going to the E.R. at 4:45am - I called the E.R. who said I probably could wait for a urgent care to open or talk to Dr.?s office. My breathing was some better. By 6:10am I was so tired I fell asleep. At 10am my B/P was 138/77 p53. Still very weak, coughing, wheezing, and trying to get rid of phlegm. I had no other symptoms. I called my Dr. who got me in a urgent care in her building at 3pm. That evening I started Postural Drainage which helped in getting rid of the phlegm. I have continued that still. March 16 ? I ?chatted? my doctor to let her know all that was going on. She scheduled me to see the Respiratory office in her building on the next day. I was feeling much better ? little nasal dripping, lungs felt better, March 17 ? Wednesday ? went to Respiratory appt but declined treatment because I felt so much better. More energy, better lungs than Tuesday, wheezing gone, less phlegm, still some coughing ? which is okay with me. I think this is a severe enough reaction that I should not have the second dose ? which is known to be more severe than the first.

"Pt presented to Clinic for her vaccine. Post vaccine, pt was feeling faint/weak and was pale. Pt sts feeling short of breath prior to arrival. Pt has hx of lung cancer. Pt was drained last at home on 3/14 per pt husband. EMS performed 12 lead and checked vitals. Pt color improved upon lying on stretcher for a few minutes. Pt's pulmonologist was contacted to see if they want her to go to her appointment scheduled at 1330 or to be transported to ED. Pt. was then transported via EMS to ED." Pt was inpt from 3/18/21 - 3/21/21 with diagnosis of E. Coli bacteremia, recurrent left pleural effusion with drain in place, resolved hypoxia on oxygen, follicular non Hodgkin's lymphoma, pancytopenia, poor appetite, insomnia. Patient was started on cefepime and then Rocephin per Infectious Disease team but she continued to the duration of this admission until ultimately transitioning her to oral antibiotics with Cipro twice daily to complete 7 day course from 03/19; this prescription was sent to her pharmacy upon discharge. Discharged home with hospice services (per pt /family preference) for comfort care

After patient left vaccination site (25 min later) she had tightness on her chest,and difficulty breathing for over 10 min. Pt drove home, and she felt better like 1 hour later. Three days later, on 03/07/2021 she was seen by her provider who ordered her: 1.Stress test, 2.Eco-cardio Doppler, 3. PFT (Pulmonary Functional Test). Provider didn't tell patient not to take the second dose of Pfizer vaccine, but to wait until patient completes these tests. Patient understood she must wait for her provider to indicate if she is allow to get Pfizer Anti-covid vaccine second dose, or not.

She had been in her usual state of health until tonight. Assisted living facility staff called. He mentioned that the facility staff had earlier noticed that she was dragging her right foot and and has been needing more assistance with activities. The patient was walking and did not feel well. She was lowered to the ground and had a witnessed cardiac arrest. The ambulance was called and she was reportedly found to have pulseless electrical activity. She was given Epinephrine and Amiodarone with return of pulse. The patient was brought to the Emergency Room and was evaluated by ER physician. EKG showed atrial fibrillation, ventricular rate = 66, RBBB with Brugada pattern. She was emergently brought to the Cath Lab. Cardiac catheterization showed normal coronary arteries but EF 35-40%. Repeat EKG showed atrial fibrillation with rapid ventricular response = 110, RBBB. Therapeutic hypothermia was initiated. The patient was admitted to the ICU on mechanical ventilation with TV 350 RR 14 PEEP 5. She is sedated with Propofol and Fentanyl IV. She is on Levophed IV. ABG showed pH = 7.22, pCO2 = 53, pO2 = 66, O2 sat = 88%. Lactate level = 9.5. WBC 8.8, Hgb 13.4, Hct 46, Platelets 138. Na 138, K 3.2, Cl 102, bicarb 20, BUN 16, Crea 1.19, estimated GFR = 44 mL/minute. Magnesium 2.7. Glucose levels have ranged from 273-312. Pro-Calcitonin = 0.26. Albumin 3.7. SGOT 262, SGPT 294. Troponin elevated at 47. Pro-BNP = 600. Urinalysis showed large blood. Chest x-ray showed vague peripheral pneumonitis. Endotracheal tube is in place. COVID-19 test by PCR is negative (2/5/21). COURSE IN HOSPITAL The patient was admitted to the ICU and was followed by Pulmonary/Critical Care. Patient was maintained on mechanical ventilation, sedated with propofol and fentanyl IV. Vasopressors were administered (Levophed IV). She was managed with therapeutic hypothermia. She was followed by Cardiology. Foley catheter was inserted for close input/output monitoring. Neuro checks, vital signs, daily weights, pulse oximetry, cardiac telemetry and fingersticks were monitored. She was given sodium bicarbonate IV due to metabolic acidosis. She was also given insulin IV drip. Potassium chloride IV was administered due to hypokalemia. The patient was given amiodarone IV. Platelet count was noted to be low but stable. Glucose levels were within acceptable range. Metabolic acidosis resolved. Hypokalemia resolved. Hypomagnesemia resolved. There were elevated LFTs which improved. Elevated CPK also improved. She was taken off hypothermia protocol. Sedation was decreased and she was able to open her eyes with verbal stimulus but unable to follow commands. Ammonia level was normal. Neurology evaluated the patient. EEG showed left periodic epileptiform discharges consistent with severe diffuse encephalopathy. Chest x-ray revealed right upper lung and left mid lung increasing opacity for which meropenem IV was started. Levophed was discontinued. Initially she had peripheral cyanosis, but this resolved upon discontinuation of vasopressors. Brain MRI was done demonstrating diffuse bilateral small and moderate-sized ischemic foci throughout the cerebellum and cerebellar region suggestive of embolism. There also was chronic marked atrophy and moderate small-vessel gliosis. CIRCUMSTANCES SURROUNDING DEMISE Based on neurologic evaluation, her prognosis for meaningful neurologic recovery was thought to be extremely poor. The patient was evaluated and followed by Palliative Care. She does not have family members and had designated her neighbor friends as her power of attorney. They have known the patient for a ling time and they know that she does not want to live like this. A decision was therefore made for comfort care measures only. Compassionate extubation was performed on February 12, 2021. The patient passed away on February 12, 2021, at 6:39 p.m.

severe pain emanating from injection site; traveled upward over shoulder; continued up right side of neck; heavy right earache; sore throat; headache forehead and across top of my head; dry heaves; feverish/chills/shivering; feverish/chills/shivering; words mixed up; Felt pain in center chest; congestion across bronchial area and developed upper respiratory congestion temporarily; congestion across bronchial area and developed upper respiratory congestion temporarily; fatigued; had severe coughing spell which included choking and further nausea; had severe coughing spell which included choking and further nausea; severe nausea; Ripple effect across bridge of nose; strong metallic odor and taste within mouth; moving from back of throat and nostrils; it is both painful and difficult to raise my right arm very high; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6060, first dose) solution for injection intramuscular in the right arm on 09Mar2021 at 16:00 (at the age of 77-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: yes. Concomitant medication included vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Mar2021 16:15, the patient had severe coughing spell which included choking and further nausea, ripple effect across bridge of nose, strong metallic odor and taste within mouth moving from back of throat and nostrils, it is both painful and difficult to raise my right arm very high. On 10Mar2021, the patient experienced dry heaves, feverish/chills/shivering, words mixed up, felt pain in center chest, congestion across bronchial area and developed upper respiratory congestion temporarily, fatigued. On 10Mar2021 03:00 the patient had severe pain emanating from injection site traveled upward over shoulder continued up right side of neck heavy right earache, sore throat, headache forehead and across top of my head. Unspecified treatment was provided for the events. The outcome of the events choking, coughing, nausea, ripple effect across bridge of nose, strong metallic odor and taste and smell, severe pain emanating from injection site upward over shoulder continued up right side of neck heavy right earache, sore throat, headache, dry heaves, feverish, chills/shivering, words mixed up, Felt pain in center chest, painful and difficult to raise my right arm very high, fatigued was not recovered. The outcome of the event congestion across bronchial area and developed upper respiratory congestion temporarily was recovering. Since the vaccination, the patient has not been tested for COVID-19.

She has constant spiking of her blood pressure (BP) and lack of sleep/She has been in and out of the hospital for her high BP/admitted to Hospital with 200/103 Bl; she has constant spiking of her blood pressure (BP) and lack of sleep; Racing Pulse; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; This is a spontaneous report from a contactable consumer. A 77-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EL9262), via an unspecified route of administration in left arm on 25Jan2021 (vaccination age 77 years) at single dose for COVID-19 immunization. Medical history included: cholesterol, spinal fusion L4/5, stenosis, allergies to medications, food, or other products: kefex, Zithromax, levofloxacin, oxycontin, methylprednisolone, Lisinopril, ezetimibe, Amlodipine. She reported she has constant spiking of her blood pressure (BP) and lack of sleep for 37 days (average 1-3 hours daily), since the vaccination. She described the following: She has experienced "dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function". When she "lays down", her "heart is racing so fast and [her] BP gets so high that it won't let [her] sleep". She feels like her "body is going crazy". She "cannot get more than 2-3 hours of sleep other than 1-2 exceptions". Also, her "BP wakes her from a dead sleep". When she wakes up, she usually "takes a rice [pad] and applies hot and cold to her neck, and she sometimes takes some Tylenol". "Every time [she] wakes up, her BP [readings] are around 152/101 and 160/97. She has been in and out of the hospital for her high BP. After the hospital, she called (Number) because her BP "was off the chart". Her cardiologist ruled out heart issues. She did an "echo, a stress test and EKG". On 01Feb2021 she was admitted to hospital with 200/103 blood pressure. Ruled out cardiovascular & placed on Amlodipine. Now 37 Days later with many visits to doctors, blood pressure remains high. Cardiologist ran stress test & echo with no heart issues. Placed on many Blood Pressure Medications that also created side-affects (urination, flushing, dizziness, extreme headaches); Amlodipine 5 mg, Metoprolol 25 mg, Alprazolam 0.25 mg as needed, Propranol 20 mg. Today, picking up yet another (Hydralazine?) as last-ditch effort. BP daily spikes remain high (160/99 and 175/100). Racing Pulse & BP wakes me out of a dead sleep within 1-2 hours. So weak & constant neck pain that feels like someone is placing pressure around my neck. The blood pressure medication received are the following: Amlodipine from 1Feb2021 until 9Feb2021. She explained it work well to manage her BP but she "could not urinate and had red flashes in [her] face"; therefore, it was stopped by her cardiologist. She was off the BP medication from 9Feb2021 until 17Feb2021. Metoprolol from 18Feb2021 until 25Feb2021, but it didn't work. She explained it was stopped by her doctor because of side effects. Propranolol in combination with Alprazolam as needed for anxiety. She explained she "took 3" of the tablets for anxiety. Hydralazine 25mg which she started yesterday, after seeing her cardiologist. She explained she only got 3 hours of sleep last night. She woke up around 1:30am/2am" her heartrate was at "93" and she put heat and cold on her neck to settle the pain. She specified the headache and pain were so bad it lasted for 1.5 hours, and her BP was 150/93 at 3 am .She added she had a "red and flushed face" and therefore took a "Benadryl at 4am". She explained her BP was down to "125/78", after taking the Benadryl, but got up to "147/90" at 7 am when she attempted to call Pfizer. She explained she has "done [her] due diligence: she consulted HCP, did all the test, she attempted to go for walks and do activities she can tolerate, but her symptoms persist. She added she use to golf and cannot anymore. She explained her symptoms are persisting until this day and her body won't handle it further. She mentioned she knows she is COVID-19 free because when helping take care of her quadriplegic son in the summer, she tested negative. Outcome of events was not recovered.; Sender's Comments: Linked Report(s) : PFIZER INC-2021277006 same patient, different vaccine dose/AE.

chills, headache, fatigue, shortness of breath, heaviness on chest for 2-3 days and shortness of breath and heaviness on chest is ongoing

Pain in left left behind Calf also behind Thigh Swollen vein in left arm from wrist to high way up my arm . Some pain and lumps. Fast heart rate

Presented to emergency department with complaint of shortness of breath and chest discomfort. She reports shortness of breath began last night. States shortness of breath is exacerbated with exertion. She also reports generalized chest discomfort with shortness of breath. Recently placed on an antibiotic on the 22nd for a bilateral lower leg skin rash. States dermatologist was unsure what kind of rash or what the rash is, so biopsies were obtained and patient is to return next Wednesday for results. Otherwise respiratory history has had asthma as a child but has not had any exacerbation or symptoms as an adult. She recently received her second COVID-19 vaccine. Denies palpitations, fever, chills, congestion or cough.

Patient admitted to hospital with altered mental status and fever. Found to meet SIRS criteria by recurrent fever and tachycardia, but no white count and otherwise hemodynamically stable. Urine cultures and blood cultures were drawn and did not demonstrate growth. Body imaging was done without e/o of infection. Patient started improving 1 day after admission (2 days after the second Pfizer COVID vaccine) without much intervention save for supportive care (antipyretics, antiemetics, etc.)

Cardiac arrest resulting in death. I actually do not know the name of the vaccine or which type it was it was her 2nd one and it occurred today at 1:30 pm

1:30 pm after shot at 11:30 heart started to beat rapidly and erratic. Wouldn?t stop after an hour. Went to emergency part of hospital. Took ekg, drew blood to see if anything was not correct, had chest X-ray. All came out fine except ekg. Did not settle down. ER doctor called my doctor and he said other AFib patients have had this happen also. Er doctor agreed with my doctor. Also had no chest pains or shortness of breath or dizziness. Told to take Tylenol for a couple days and was released. The erratic and fast pace of my heart has eased some but still persists.

Community member, Dose #2 During post vaccination observation, lightheaded & elevated HR to ED with headache & anxiety, improved & discharged to home

04/07/2021 5:25 am woke up with tight chest and shallow breathing. Immediately took asthma medication. I usually take 2 puffs of Advair and 2 puffs Xopenex an hour or two after waking (daily treatment. I don't wake up with a tight chest. 6:30 a.m. breathing has normalized. Have headache, earache and some nasal drainage.

Couldn't breathe/shortness of breath; Back pain; blood pressure was high; was just sick; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 (at the age of 77-years-old) (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood pressure abnormal, cancer in her left lung, ongoing blood cholesterol abnormal, ongoing gastric disorder, ongoing diverticulitis Verbatim: Virticulitis. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) taken for blood pressure abnormal; atorvastatin (ATORVASTATIN) taken for blood cholesterol; hydralazine taken for blood pressure abnormal; lisinopril (LISINOPRIL) taken for blood pressure abnormal from Feb2021 and ongoing; pantoprazole taken for gastric disorder from 2020 and ongoing. The patient had her first shot and after that, a week after she experienced some adverse events like back pain and sickness. After the patient started experiencing back pain, and got progressively worse, she was having problem breathing/Shortness of breath was reported. The patient was ambulanced and mentioned she was brought to the hospital/stayed with her doctors overnight due to the experiences she had. She had blood work done and based on the results, they suspected a blood clot on her lung and her CT scan did show that she did not have a clot in her lung. It was also reported that they did blood test and urine test and that all that EKG because the patient had her blood pressure gone considerably high and in the blood test. She was prescribed to take Tylenol every 8 hours and a to put a back patch on the left side of her back where she is experiencing pain. Caller did not provide if she was admitted to the hospital, or if she just stayed in the ER overnight for observation. Now, she wants to know if she will still proceed with her 2nd shot on 29Mar2021. The patient underwent lab tests and procedures which included abdomen scan: normal, no indication of blood clot on 17Mar2021, angiogram: normal, no indication of blood clot on 17Mar2021, blood pressure measurement: high, blood test: a blood clot on her lung on Mar2021, computerised tomogram: normal, no indication of blood clot on 17Mar2021, covid-19: negative on 17Mar2021, x-ray of pelvis and hip: normal, no indication of blood clot on 17Mar2021. Therapeutic measures were taken as a result of back pain (back pain). The seriousness of the events back pain and Couldn't breathe/shortness of breath was hospitalization. The outcome of the events back pain was recovering. The outcome of the other events was unknown.

SEVERE HA , DOCTORS SAYS SE HAD ISCHEMIC STROKE , NOT SURE IF RELATED TO THE VACCINE What happened as a result of the adverse event? SAW DOCTOR

Reports dizziness immediately following vaccine inject. She reports same symptom with first vaccine, and was transported to Rush ER. VS 130/78, 68, O2 sat 99 %

Pt self-reported heart palpitations and dizziness 1 day post-vaccine. Resolved on its own with no treatment.

Extreme headache rot. Side of head, extreme back pain in left wing one , Runny nose, Chills took Tylenol and napped for hrs for two days. 2 heavynosebleeds right nostril one wk later. 2nd shot on 2-21-2021, Hot, 4 nights of night sweats, Two more bloody noses right nostril. Tired

Pt received her 2nd covid 19 vaccine on 4/7/2021 and was admitted severe sob, respiratory failure and hypoxia on 4/10/2021/ she remains hospitalized as of 4/14/2021. she is being treated with oxygen, antibiotics, steroids and nebulizers.

she and they thought she was having a heart attack; she must have passed out because she didn't remember all the tests; she got a sharp pain underneath her left rib cage/pain was number10/still had pain off and on, periodically; broke out in sweat, real bad, number 10, she broke out in a clammy sweat; hard to breath, she got a sharp pain underneath her left rib cage; the muscle that goes around her heart, it was having like a charley horse; heart rate, She says 102, 103, it went up to 200 in the ambulance.; chest pain; Nausea; hard to breath, she got a sharp pain underneath her left rib cage; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3246), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as single dose for COVID-19 immunization. Medical history included ongoing atrial fibrillation for a about 6 years , ongoing anemic for the last 20 years, glaucoma from 1998, had both eyes operated on and in 2016 she was operated on again, cataract had this 4 years ago in she says, in 1918, 1919, she clarifies 2018, Cardiac pacemaker insertion which pacemaker that controls her heart so the pulse does not drop below 65. She says that pacemaker was implanted, she thinks, 2014 maybe, blood pressure, arthritis throughout her body and had 30 operations, body doesn't absorb what she eats, anxiety, asthma, muscle spasms; she reported she has had a lot of surgeries, both of her ankles have had triple fusions, these were in 2005, 2010, 2014, 2018, both her ankles were fused, she had 5 surgeries on her feet; she has had both of her knees replaced because of arthritis, 2012 and 2015 she believes, had numerous other surgeries and she doesn't want to go through all of them, a right shoulder reverse rotator cuff repair, she had a rotator cuff put in, she doesn't have a rotator cuff, this happened in 2019, her left shoulder, because of an automobile accident, rotator cuff was so damaged that they couldn't repair it, she has minimum use of her left arm and has had operations on her left shoulder in 2005; had a pacemaker put in about 6 years ago, the next morning they kept her overnight, they came in, they took an Xray, she had to go back 2 days later because the lead had come of the heart, they had to go back in an reattach the lead to the heart; 2 years ago her pacemaker was going all over her chest, the doctor did not believe her and it landed under her armpit, it was the size of an orange, the doctor thought it was a lump, she went to the hospital, her pacemaker started falling apart, they took it out and put a new one in, it was about 4 years ago; a lump in her breast, she has been put under 30 times, they were all necessary, nothing for glamorizing; had surgeries in her left arm and some fingers than were numb. There was no prior vaccinations within 4 weeks, no events prior vaccinations and no family history. Ongoing concomitant medication included baclofen taken for muscle spasms for about 2 years, calcium for arthritis and her bones degenerate for 30 years, ergocalciferol (CALCIFEROL VIT D) taken for gets anemic real easy for 20 years, duloxetine taken for anxiety, taking this about 3 years ago; ferrous sulfate taken for anemic real easy for about 20 years; folic acid taken to rebuild cells taking this she thinks in 2015, furosemide taken for a diuretic to get rid of fluid for 2 years, metoprolol tartrate taken for atrial fibrillation, and blood pressure, taking this since she had her pacemaker put in; montelukast for asthma for 20 years; hydrocodone bitartrate, paracetamol (NORCO) taken for arthritis for 20 years, and warfarin taken for blood thinner/thin the blood out so she doesn't get blood clots; and adults vitamins for bone supplement and metabolism for 20 years as her body doesn't absorb what she eats. She says she takes a lot of medications and when she does blood bloodwork she was low so they make her take them. The patient previously took rivaroxaban (XARELTO). On 06Feb2021, the patient experienced she thought she was having a heart attack. The patient reported that she had to call an ambulance at 11:30 at night, she thought she had a massive heart attack. She had chest pain, nausea, it was hard to breath, she got a sharp pain underneath her left rib cage. She stated that when the ambulance got here they thought she was having a heart attack, they did nitroglycerin, when they got to the house, when in the ambulance on the way to the hospital they did another pill of nitroglycerin when they got to the hospital. The pain was a number 10. She stated she broke out in sweat, once they got her all hooked up they got to the hospital 6 miles away to the hospital. She was there for 2 full days, they did Xrays, dye in her, checked her hears, and did bloodwork. When she had chest pain, she reported they gave the morphine, it lasted about 6 hours; she still had problems breathing, they took her, she must have passed out because she didn't remember all the tests, she was in and out of it, the severe pain stopped after 6 hours, still had pain off and on, periodically. When she got pain in the ambulance then the nausea went away. After the hospital nitro and another shot for the pain, the nausea stopped. After the hospital after this they gave morphine and the pain subsided a little but didn't totally go away until 6 o'clock in the evening, she still had problems breathing because every time she breathed she got pain under her left rib cage. She says the sweat was at home, real bad, number 10, she broke out in a clammy sweat, on the 6th when she was having pain. She says that after the hospital, a couple days after that, she saw her cardiologists, he told her what happened, it was related to vaccine, it was the muscle that goes around her heart, it was having like a charley horse, he says it felt like you're having a heart attack, her tests said her heart was good. She talks about her blood pressure and heart rate, and says 102, 103, it went up to 200 in the ambulance. She says they thought it was a heart attack, her blood pressure was usually low blood pressure and all the symptoms she was having was because of her muscle having a charley horse that felt like it was coming from the heart, if they had contacted him, he said she would have just needed a massive amount of anti-inflammatory and it would have stopped the pain. The events required an emergency room visit. She wanted to know if anybody else has been hospitalized for massive heart attacks and says that's what she was having. The patient had her second shot on 22Feb2021. Outcome of event nausea was recovered on an unspecified date; and outcome of the rest of events was unknown.

Bleeding; Blood in her stools; Volumes of regular stool/went to the bathroom 20 times; Did not have blood on the toilet paper, no rectal bleeding, and had volumes of regular stool/there may be something in the vaccine that could help her Irritable Bowel Syndrome; Aching arm; This is a spontaneous report. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9267; Expiration date was not reported) on the left arm on 28Feb2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the Health Department. Medical history included ongoing irritable bowel syndrome for over 50 years; high level of hormones; was losing hair; and had rectal bleeding from Jan2021 to an unspecified date. Concomitant medication included ongoing spironolactone from Jan2021. On 01Mar2021, the patient did not have blood on the toilet paper, no rectal bleeding, and had volumes of regular stool, and mentioned that there may be something in the vaccine that helped her irritable bowel syndrome; and had aching arm. On 02Mar2021, the patient was bleeding; had blood in her stools; and had volumes of regular stool, and went to the bathroom 20 times. The patient did not receive any treatment for the reported events. The outcome of the events was unknown. The patient had received the second dose of vaccination on 28Mar2021.

Pt admitted to hospital on 3/4/2021 with Extensive DVT to the LLE. No history of cancer or thromboses. History of redness and swelling to entire left leg starting on 3/1/2021. Received Heparin infusion in hospital. Currently receiving Eliquis p.o. Pt also underwent trombectomy with iliac stent placement by IR.

Severe fatigue after first dose. 1 week after 2nd dose 3/18/21, developed worsening fatigue with 43% blasts on peripheral CBC indicating a transformation from CMML to AML.

Pfizer COVID Vaccine EUA Patient received Pfizer vaccine 3/3/21. COVID Positive 3/20/21 3/20/21: Patient is a 77-year-old female with past medical history of bilateral breast cancer (post bilateral mastectomy), CHF, CAD, CKD stage II/III, HTN, obesity, obstructive sleep apnea (not on CPAP), and spinal stenosis presenting today. Patient presented via ambulance her daughter. Patient was unable to cooperate, HPI obtained from patient's daughter. Patient's daughter stated approximately 1 week ago patient started to be "unresponsive" and was not talking/responding often. Mostly answered "yes/no" questions. She seemed the be "acting different". When asked, pt denied any pain over the last week. Her daughter denies any infectious process such as fever/chills or cough cough. Her daughter notes approximately 2 years ago patient has similar event, was seen in the ED, but nothing remarkable was found. Reviewed today, patient's daughter stated the patient had a "shaking "episode in had "on responses ". It was described as "shivering" and a blank stare during this unresponsive state. Episode lasted approximately 1 minute. The daughter denied any history of strokes or seizures. Pt usually lives with another daughter and so the daughter present was unable to verify if pt takes her prescribed medications daily. Her daughter denies knowing any Advance Directives or POA set up. Smoking, alcohol, and illicit drug use were denied. Pt was seen 9/2019 for a similar event with concern of stroke vs syncope vs TIA that resolved on its own. 3/25/21: 77-year-old F presented on admission that began approximately 6 days prior. HPI obtained from patient's daughter on admission. Patient's daughter stated approximately 1 week ago patient started to become "unresponsive" and was not talking/responding often. Mostly answered "yes/no" questions. Patient's daughter stated the patient had a period of unresponsives and was shaking her left arm on the day of admission. It was described as "shivering" and a blank stare during this unresponsive state. Left sided weakness was noted. In the ED, vitals signs significant for 88% on room air. CXR showed bilateral infiltrates in lower lobes, CT of head was unremarkable, EKG normal sinus with sinus arrhythmia, CT of chest completed due to elevated D-Dimer showed no PE but showed ground-glass airspace disease and stable 14mm nodule at lower pole of right thyroid. Pt was admitted for Acute Encephalopathy with unknown etiology. COVID testing came back positive. Patient started on Routine COVID management protocol which included IV dexamethasone, remdesivir, vitamin D, vitamin C, zinc, with daily labs (d-dimer, CPK, CRP, CMP, LDH until stable/not upward trending). Patient to continue vitamin D, vitamin C, and zinc upon discharge to rehab. Patient had MRI obtained which showed scattered foci of acute infarcts right posterior parietal lobe/multiple foci of acute microhemorrhages likely hypertensive. Neurology consulted, stated infarct could be due to COVID so continued on lovenox and stopped aspirin. Recommended to keep blood pressures 110-140/80-90. Last documented note from neurology was 03/22/2021 - contacted multiple times but unable to reach afterwards. Discharging patient on xarelto for 30 days and recommending to follow-up outpatient to transition to aspirin and plavix. With this management on board, patient's symptoms improved significantly since admission. Patient discharged in stable condition to rehab.

Headache; Tiredness; Difficulty breathing; Dizziness; Weakness; Nauseated; blood pressure was up; Teeth chattering/chills; couldn't hardly stand up; This is a spontaneous report from a contactable consumer (patient reported herself). A 77-year-old female patient received first dose of BNT162B2 (COVID shot, Solution for injection, NDC number: Unknown) via an unspecified route of administration to her right arm on 24Feb2021 3 PM (Batch number: EN6201) as single dose for Covid-19 immunization. Vaccination Facility Type: Hospital. The patient's medical history included bladder issue (she had just been to see her doctor for bladder issues, this was prior to taking the COVID shot). Concomitant medications was reported as none. On 24Feb2021, the patient experienced blood pressure was up, teeth chattering and could not hardly stand up. On 24Feb2021 3 PM, she experienced nauseated. On 25Feb2021, she experienced headache, chills, tiredness, difficulty breathing, dizziness and weakness. Caller, reporting on the COVID shot, said that she had a reaction and had to go to the hospital. She was calling to report. It was explained that she was sick all over which she clarified as being nauseated. At first she said it started an hour to hour and a half after the shot but then clarified she got the shot at 3 PM and the event started that night. The caller was treated and released. She went to the hospital about 6 PM and was sent her home about 9 PM. She was given a steroid shot, Benadryl, her teeth were chattering and was given a pill for that. It was noted while at the hospital she could not hardly stand up. Also, her blood pressure was up and they had to get that down before she left; she was given a pill to get that down. Her blood pressure was 225 but she did not know the bottom number. She was taking the medication given and taking it easy. She was having headache, chills, tiredness, difficulty breathing, dizziness, and weakness. This all started today. The nausea was ongoing from yesterday. The caller explained that she did not think that she should take the second dose if this was what she experienced after the first dose. It was reported that the patient went to emergency room. Relevant tests were none. Outcome of the events nauseated, headache, chills, tiredness, dizziness, weakness was not recovered; blood pressure was up was recovered on 24Feb2021; and other events was unknown. No follow-up attempts are possible; No further information is expected.

3/8/21 ED: c/c of SOB x 2 days. Pt c/o diarrhea. Pt states that she received the 2nd pfizer vaccine 2 days ago. O2 at triage was 96% on RA. She was seen in this facility Saturday 3/6/21 for HA. CTA and labs unremarkable. She reports persistent HA, though improved when compared to Saturday. Reports multiple episodes of NB diarrhea. No other medications or treatments tried. In the ER she was seen to have a significant leukocytosis with wbc in 26, AKi with SCr in 2.7, thombocytopenia. Ordered CT scan which showed congestion and LLL pna and trace effusion. ID, Cardiology and Nephrology consulted. Treated for acute kidney injury with hyposmolar hyponatremia, on tolvactam, Sodium 133, trending up. Treated for sepsis with gram negative bacteremia d/t e.coli, completed ceftriaxone course. Treated for essential hypertension, elevated troponin, BP now controlled. Discharged home on 3/17/21

Very Elevated blood pressure. The same for my husband who got shot at the same time. Also a friend.

Mild sensation in left chest area and along left side neck, along with mild shortness of breath starting about 3/20/21 Has since disappeared. On or about 3/25/21 a hard, painful rash appeared on buttocks and has since healed. A second larger painful rash appeared in a different area on or about 4/5/21 and lasted about 2 weeks. Along with rash is tenderness of skin in surrendering area of rash, there is pain under breast area which extends to back and persists.

affected her balance and walking/out of balance; affected her balance and walking; TIA; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 25Mar2021 10:00 (batch/lot number EP6955 and expiry date not reported) at 77 years of age as single dose for covid-19 immunization in a clinic facility and not in military facility. Medical history included Stroke from 2014 and another in Dec2018; the patient had MRI to confirm, ongoing blood thinner (therapy). Concomitant medications included rivaroxaban (XARELTO) taken for blood thinner from Jan2019 and ongoing. The patient previously took first dose of bnt162b2 on 04Mar2021 at 77 year of age for covid-19 immunization and experienced arm soreness, Eliquis for 2.5 years after the first stroke for blood thinner and couldn't deal with Eliquis very well and made her feel like she was dying. The patient had no prior vaccinations (within 4 weeks). On 30Mar2021, the patient experienced TIA (transient ischaemic attack). The patient informed that at first she had nothing then five days after the second dose (30Mar2021), she had a TIA. The TIA that she experienced was so sudden and so alarming. It affected her balance and walking (unspecified date). The patient informed that when she was walking to pick up a stick she felt out of balance. The patient was walking like she was a drunken sailor and was staggering. It was the oddest thing. The patient has not talked to her doctor. The TIA was quick then it was gone. It was scary. The patient did not seek treatment (no treatment received). The outcome of the event TIA was recovered on 30Mar2021, while unknown for the rest of the events. The patient considered that the TIA may have had nothing to do with the shot, it happened 5 days later.

This 77 year old white female received the Covid shot on 03/13/21 and went to the ED on 4/10/21 and was admitted on 4/10/21 with hyponatremia with excess fluid volume, acute respiratory failure with hypercapnia, transient confusion, acute heart failure, shortness of breath and went to the ED again on 4/18/21 with cerebral infarction and died on 4/29/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Uncontrollable body shaking, high fever, cold and hot sweats, was not aware at times of where I was or what day it was, my husband had to hold me to help stop the shaking.....NOT CHILLS, could not walk, diarrhea. This happened also on March 31st, my FIRST injection.....My heart was beating out of my chest.... very scary. Please don't tell me this is NORMAL!!! I've lost at least 5 lbs. I am petrified to get the booster, if there is one, I WILL NOT GET IT... ANY SUGGESTIONS.

stroke caused by a blood clot; stroke caused by a blood clot; right arm went completely numb; She is tired; shortness of breath; her eyes were blurry; her head felt like somebody put a spike in it on the right side; sore arm; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06Feb2021 13:15 (Lot Number: EM9809) (at age of 77-year-old) as single dose for COVID-19 immunisation. Medical history included colitis ulcerative from Oct2020 (dropped weight, she dropped from 127 pounds to 109 pounds) , cardiac disorder, atrial fibrillation, and osteoporosis, all were ongoing. Concomitant medications included carvedilol taken for cardiac disorder, atrial fibrillation from an unspecified start date and ongoing; cyanocobalamin (VITAMIN B12) taken for cardiac disorder from 2018 (reported as has taking it close to 3 years) and ongoing; denosumab (PROLIA) taken for osteoporosis from an unspecified start date and ongoing; ubidecarenone (Q10) taken for cardiac disorder from unknown start date and ongoing; calcium, colecalciferol (CALCIUM + D3) taken for osteoporosis from 2020 (reported as a year ago) and ongoing; influenza vaccine (FLU VACCINE VII) taken for an unspecified indication, start and stop date were not reported, and vitamins NOS (MULTIVITAMIN) from an unspecified start date and ongoing, the patient started taking it when she was a senior in high school and stated because she is not the best eater in the world. There was no prior vaccinations (within 4 weeks). AE(s) following prior vaccinations: The patient stated arm is sore with flu shot and probably did when she was little when she got the loaded shot, the mumps one. She wouldn't remember that because she was little. The patient experienced stroke caused by a blood clot on 20Feb202114:30 with seriousness criteria hospitalization, sore arm on 07Feb2021, and right arm went completely numb, tired, shortness of breath, her eyes were blurry, her head felt like somebody put a spike in it on the right side on an unspecified date. The event stroke caused by a blood clot result in emergency room visit.The patient was hospitalized for stroke caused by a blood clot from 23Feb2021 to 24Feb2021. The patient reported that she received the first dose and she is thankful she got it on 06Feb2021 and the only side effect she had was a sore arm. Stated on 20Feb2021 she had a stroke caused by a blood clot obviously, she ended up in the hospital. She didn't think at the time, doesn't fault the physicians that took care of her. She didn't think it was related and her eldest son thought it was related. The patient stated they thought it was a mild stroke and after they did the C scan the neurosurgeon, while she was lying in the hospital bed, looked at her assistant and said he couldn't believe that she was talking and walking. The patient stated part of it was ignorance on her part, everyone thought it was the left side that numbs, but hers was the right side. Stated she didn't fall, she dropped something and went down to get it and her right arm went completely numb and she couldn't get back up and she tried to push with legs and couldn't get up. Stated all of a sudden her eyes were blurry and then she never gets headaches and her head felt like somebody put a spike in it on the right side, stated it is supposed to affect the left side. stated she has a heart problem. The patient stated she had a sore arm for about a week, lasted for a few days. stated she gets a sore arm with the flu shot. stated when she would roll over to lay on her left side and roll over on that arm it was enough to wake her up. stated it lasted about 5 days. She couldn't figure out why it was lasting so long. Stated the second thing that happened was that she went to her son's home that night for dinner, hadn't told him about it and while she was eating dinner she asked am if she leaning to the left and he said yes, she was and that her words were being slurred and only lasted for about 10 mins. Stated she didn't call and ignorance is unreal with this stuff. She went to urgent care the next day and they didn't call the ambulance. When she went to the doctor on 23 Feb2021 she was sent immediately to Hospital so she could go through the ER and that's when the neurosurgeon became involved. Stated right now her balance isn't quite right but she is driving and she was taking care of herself and they didn't send anyone home to help her. She was not having any problem talking. Stated she was not going to get into this and will beat it and get back to normal. She was tired a lot, which they said it's normal. Stated she was a real dynamite. Stated it is improving slowly, she was extremely tired and not taking her long walk like she was used to and has shortness of breath, she was not trying to over do it. Stated she always gets a sore arm with the flu shot. Stated her pain level is lower than most people. The patient stated the sore arm started late evening but the next day was really hurting and the main thing was rolling over. The patient stated she didn't take anything for her sore arm, she won't even take an aspirin because some of these Advil medications will mix with the heart medications. Stated in the hospital they were giving her medications she had through an IV in her arm but doesn't know what was going through that. Stated they put her on a blood thinner and they were testing the blood thinner through the IV. She was so miserable, she just wanted to go home and get a good nights sleep. Stated they took all kinds of test, checked her oxygen and had to have a certain number before she could go home. The patient received treatment for event stroke caused by a blood clot and not received treatment for sore arm . The outcome of events stroke caused by a blood clot was resolving, of event sore arm was resolved on 12Feb2021, of other events was unknown.

This 77 year old white female received the Pfizer Covid shot on 4/22/21 and went to the ED on4/24/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified

afib and tachycardia for 3-4 days; afib and tachycardia for 3-4 days; chills; lethargy; kind a brain fog; felt like I had a cold spent 2 days feeling like that; She has as temperamental immune system. She is extremely sensitive. She reacts to everything; This is a spontaneous report from a contactable consumer (patient) via Medical Information. A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 72-year-old for COVID-19 immunisation. The patient medical history included temperamental immune system (she is extremely sensitive. She reacts to everything). The concomitant medications were not reported. on an unspecified the patient experienced atrial fibrillation (AFIB), tachycardia, chills, lethargy, brain fog, felt like i had a cold spent 2 days feeling like that, hypersensitivity. Therapeutic measures were taken as a result of AFIB, tachycardia. The outcome of events was unknown. The course of events was as follows: On an unspecified she had reacted to the first vaccine: the first day she was fine. The next day she had chills, lethargy, kind a brain fog, felt like she had a cold and spent 2 days feeling like that. On Day 3 she had AFIB and tachycardia for 3-4 days saw the heart doctor and got medicine for that. She had a temperamental immune system. The stress test was super important. She was wandering if she had the Pfizer vaccine a week after the stress test. She got it at the university, and she wandered if they were restricted to give it to her a few days after my scheduled date: They wanted to rule out blockage in her heart. She was having a test done around the same time as the 2nd Pfizer vaccine. She wanted to know if she could get the 2nd dose of the Pfizer vaccine later/ a week after the stress test. She wanted the vaccine, it was important. On 04May21 she was going to have a dye based test checking your heart, a stress test. The stress test was scheduled the same morning as her 2nd dose of the Pfizer COVID vaccine. She was advised to consult with your doctor or pharmacist for further guidance.

Fatigue extreme; Not want to eat breakfast, did not have energy just wanted to sleep/ feel very weak; Dizzy; Spinning around like in a tunnel/ Vertigo; Had like 4 attacks a day and I did not hold down laying in bed and looking up ceiling and ceiling starts spinning; Frightening; little warm in the arm; Resting heart rate but the oxygen was running low it was like 84-80; I don't feel good;; Hit me like a rocket; This is a spontaneous report received from a contactable consumer (Patient) via a Pfizer Sponsored program. A 77-year-old female patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not Reported), via an unspecified route of administration on 16Feb2021 as single dose for COVID-19 immunisation. edical history included ongoing hypertension, ongoing COPD (chronic obstructive pulmonary disease) and ongoing acid reflux. Concomitant medication included metoprolol succinate at 50 mg, once a day for hypertension, alprazolam (XANAX) at 2.5 DF, twice a day for anxiety, albuterol at Every 3 to 4 hours as needed for chronic obstructive pulmonary disease, budesonide at 5 mL, twice a day for chronic obstructive pulmonary disease, arformoterol tartrate (BROVANA) at twice a day morning and night for chronic obstructive pulmonary disease, tiotropium bromide (SPIRIVA) Inhaled through the mouth, once a day as a bronchodilator, aspirin, omeprazole (PROTONIX) at 40 mg, once a day for Acid reflux, diltiazem at 300 mg, once a day for hypertension and unspecified vitamins. Patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization received on 26Jan2021 and experienced warm arm. It was reported that, the patient had a very bad experience with the shot. On Tuesday in this rehabilitation, they were giving out the shot, this was her second shot in this place. The first shot she had no reaction, just a little warm arm. On an unspecified date in Feb2021, the second hit her like a rocket, the day after the shot or the day over the shot just a little warm in the arm nothing really, the next day woke up extremely fatigued did not even want to eat breakfast did not have the energy just wanted to sleep and she said what was going on with her and then she got up very fatigued. Then the physical therapist came in to give physical and they "supposed to" (not clarified) her. It showed a good blood pressure everything was good resting heart rate, but the oxygen was running low it was like 84-80 and she knew she was because she could feel it while she was walking and patient told them she does not feel good, she felt very weak and thought it must be from the shot. So that went on then and go on to this same thing very dizzy on the next day of second shot on 17Feb2021, spinning. That day spinning around in like a tunnel. She had like 4 attacks a day and she did not hold down that she was laying in her bed and she was looking up in the ceiling and this ceiling starts spinning with the whole room. That was 4th of those on Thursday, Wednesday she was just tired, Friday she had less of them but the same thing spinning around, never fell down but again it was not while she was standing up. The physical therapist said to her sit up do not lay down in the bed. Now she was taking pulmonology medication through a nebulizer. Patient also taking bronchodilator and she take a prednisone pill 20 mg, albuterol and she take other medication. Patient did the Covid test when he had blood work up. They do a blood work up every 2 weeks here. But everything was good. The outcome for events was reported as unknown. Information about lot/batch number has been requested.

Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified SHORTNESS OF BREATH CHEST PAIN RESPIRATORY DISTRESS

feeling a little weird; Nauseous; Headaches; blood pressure went up over 220; pulse rate went way up; really ill; memory is a little off right now; felt like I am going to faint; ringing in the ears; dizzy/light headed; a really really sore arm for two days after the vaccine; allergic reaction; This is a spontaneous report from a contactable consumer, the patient. This 77-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171), via an unspecified route of administration on 29Apr2021 (at the age of 77-year-old) as a single dose for COVID-19 immunization. Medical history included allergies and sinus headaches which she takes (Excedrin) off and on for years in the past, and high blood pressure. Concomitant medications included atenolol (manufacturer unknown) taken for hypertension, start and stop date were not reported. Past drug history included the patient received a flu shot (unspecified Flu shot) with a mega reaction she was sick for weeks which was at least probably 15-20 years ago So, she never got a flu shot after that and she has never had the flu. On 29Apr2021, the patient had a really really sore arm for two days after the vaccine, dizzy/light headed, felt like I am going to faint, and ringing in the ears. On an unspecified date in 2021, she experienced allergic reaction. On 01May2021, she was really ill, and her blood pressure went up over 220 and pulse rate went way up. On 02May2021, she experienced headaches. On 06May2021, she was feeling a little weird and nauseous. On an unspecified date in May2021, her memory is a little off right now. The clinical course was as follows: the patient reported, "I had a really really sore arm for two days after the vaccine, it's okay now, I couldn't really move it. I feel I may be having a severe allergic reaction to the Pfizer vaccine (Pfizer Covid-19 Vaccine) got on Thursday (29Apr2021) of this past week. I am very light headed, dizzy and felt like I am going to faint, has ringing in the ears, and all that has been going on about a week, since last Thursday (29Apr2021). Then I was really ill last night (01May2021). It started last night when we went to bed around 11 O'clock. I have never had anything like this in my life. My blood pressure was through the roof. With a blood pressure cuff and a stethoscope, her blood pressure went up over 220 which was so high that had never happened before, so I took an extra pill (atenolol 25 mg tablet) last night (01May2021) which helped a little bit but not enough, and I really thought that I was going to pass out and be really sick. Because I thought that it was either having a stroke or a heart attack, my husband had to call ambulance to take me to the hospital last night. The systolic and diastolic and pulse rate went way up. They did chest x-ray, blood work, and urinalysis, and everything came back fine and they could not find anything. They just felt that I was just having a major reaction to the shot so they sent me home. I just got home this morning (02May2021) from having to go to the emergency room. But as soon as we got home, I started with a humongous headache and so I had Excedrin/Tylenol for headaches because I used to get sinus headaches. So, I took that, and it helped a little bit, my headache got a little better. Anyhow, I am much better right now and I am sleeping. But tomorrow it will be the same." Later the patient also reported, "Today (06May2021) I am feeling a little weird with ringing of ears and is light headed sometimes. Because of the light headedness, I feels a little nauseous. But I am a still very nauseous. I feel like I am going to faint again and my blood pressure I think has gone back up. I am trying to keep calm and trying to figure out what is going on. But I am really afraid if I am having a reaction to the vaccine unfortunately. I am dizzy and I do not want to start getting worst again. I guess I will feel better if you tell me that this happens sometimes and what can I do to decrease somehow?" She also stated that she did contact her doctor about this event but she didn't get very far. Her memory is a little off right now because she really has not felt well. She stated that her biggest thing is her blood pressure. She also stated, "The only thing that I am really concerned now is about getting the second shot because I already had the reactions by the first shot. Am I going to face the same thing or even the worse with the second shot?" Treatments were received for her blood pressure went up over 220 and headaches. The clinical outcomes of the event "a really really sore arm for two days after the vaccine" resolved on 01May2021, the event nauseous was not resolved, while the events, allergic reaction, really ill, felt like I am going to faint, pulse rate went way up, ringing in the ears, dizzy/light headed, Headaches, feeling a little weird and memory is a little off right now were unknown.

became extremely dizzy; when I came home and passed out.; Hit my head on floor; received a concussion; cut on scalp; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 15Mar2021 13:45 (at the age of 77-year-old) (Batch/Lot Number: en6205) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included atorvastatin; furosemide; and calcium. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: el9265), administered in left arm on 22Feb2021 at 02:30 PM (at the age of 77-year-old) for COVID-19 immunisation. On 15Mar2021, the patient became extremely dizzy when she came home and passed out. She hit her head on floor and received a concussion and cut on scalp. The events caused hospitalization for 2 days. The patient was tested for COVID post vaccination via nasal swab on 22Apr2021 which was negative. Therapeutic measures were taken as a result of all events which includes computed tomography (CAT) scan and electrocardiogram (EKG) with unknown results. The patient recovered from the events on an unspecified date.

Vaccine on Wednesday 4/28/21. Started to have mild headache, nausea, generalized malaise and chills on Thursday 4/29/21. Seemed to then improve but then became lightheaded and dizzy. Came to emergency room 5/2/21 at 1000. BP stable at 136/69, O2 sat 99% on room air. No significant findings on blood work (CMP, CBC, Troponin, BNP, TSH all within normal limits). Chest Xray was normal. EKG showed atrial fibrillation with rapid ventricular rate in the 150s. She was given IV diltiazem and her heart rate was controlled. She was admitted to the hospital for observation and conversion from IV to PO diltiazem. She declined oral anticoagulation. She was discharged home on 5/3/21 and instructed to follow up with her PCP and was to see cardiology.

Jaw pain up into eye; lymph nodes in the neck that made her hard to move her head; leg cramps; sleepy; palpitations; My chest has been beating like a 107 and it is normally like in the 70/Fast heart beat; lymph nodes in the neck that made her hard to move her head; I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help; I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; she was sneezing; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205, Expiry Date; UPC and NDC number: Unknown), via an unspecified route of administration on 26Feb2021 01:00 PM in the right arm at 1ST DOSE, SINGLE for COVID-19 immunisation. Patient's age at vaccination was 77 Years. Medical history reported as, the patient first states that she was medication free, but then clarifies that she does takes a vitamin D that is prescribed by her doctor. She had a lot of allergies when she was very young, she was tested for allergies. Two years ago she didn't think she was sick but her calcium was high, she had 2 parathyroid glands removed and she was stronger than she was before. She takes no pills for it, she has nothing wrong with her, outside of the cancer she had when she was 55 years old. Caller reported that the injection did not hurt for either herself or her husband, and it was wonderful. The patient states that she had no fever or chills from the vaccine, but both the caller and her husband were tired after receiving the vaccine, but caller thought it was from stress. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included an unknown vaccine and patient states as, that back a long time, when she was a youngster, when she was given whatever vaccination is needed to go to school, her arm swelled past her elbow, and she was sick for a few days. Caller does not remember which injection it was, it was whatever injection she had to have to go to school, she was 5 years old. Caller doesn't recall the name of the injection. No prior vaccinations (within 4 weeks). The patient states that she does not take the flu shot or anything like that, ever. Vaccination facility was reported as outside the distribution center in the parking lot. On an unspecified date in Feb2021, the patient experienced My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose, lymph nodes in the neck that made her hard to move her head, I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help and she was sneezing; On 26Feb2021, experienced my chest has been beating like a 107 and it is normally like in the 70/Fast heartbeat, sleepy, palpitations; On 01Mar2021, experienced leg cramps; On 03Mar2021, experienced lymph nodes in the neck that made her hard to move her head; On 04Mar2021, experienced Jaw pain up into eye. The report received as, the patient was pleased where she had the injection it didn't have swelling or get red and she does have a history of allergies and her doctor said it was ok to get the shot. The doctor told her, that if she had any eye tearing, nasal drip, or other things like that, to take a Benadryl. Caller waited 12 hours, because her eyes did start to tear, and she was sneezing and so she took a non-drowsy Benadryl, but she waited 12 hours to take the Benadryl, because she didn't want it to interfere. The patient experienced fast heartbeat started in the evening on the same day. Patient also had fast heartbeat yesterday. She reports she had a fast heartbeat; it was in the low 90s, she knows that's not fast for some people, but it was fast for her, and it would come and go like palpitations. Patient does have a machine, her heartbeat was in the 90s, and her chest has been beating like a 107 and it was normally like in the 70s. Caller was in the kitchen when she felt it, so she sat down. The patient reports that she has not experienced the palpitations today. The patient states that she was doing something in the kitchen, she's very active. She normally gets up in the morning and does the breast stroke for 1.5 hours, and patient states that she only got up to the pool once this week, and she didn't stay at the pool long because of the leg cramps. The patient reports she did have a fast heartbeat yesterday. The patient reports that she also started to have a lot of cramps in her legs, which she has never had before in her life. The patient states that 2 days ago, the lymph nodes in her neck must have been swollen, and it hurt so bad last night, she didn't know what to do, she took regular over the counter Tylenol and it did help. The patient states that it's not bothering her today. it's right down the sides of her neck. She looked on the internet for lymph nodes in neck, she knew she had lymph nodes in her neck and it was really, really tight. It was both sides of her neck. It's not as bad today because she couldn't stand it anymore last night so she could take Tylenol. She was to a point sitting in a chair, how could she stretch her neck because it hurt so bad. But this morning she can move it pretty good. She told her husband if it continued that she would go to hospital. She was concerned with if she should get the second shot or not. She was wondering did the first Covid shot cause this. She did take Tylenol this morning, she also reports jaw pain and up into her eyes, that started yesterday, and it has been relieved. She's concerned if she got this with the first shot, could she get it with the second which was scheduled on 19Mar2021, and she was a little doubtful about getting that second shot. The patient states that she was very seriously thinking of not getting the second shot, because she had an awful lot of discomfort with this first shot. The patient states that it wasn't that she was tired, she was just sleepy, she was sleepy on the day she got the vaccine, and then on Saturday, 27Feb2021 she had 3 naps, then on Sunday, 28Feb2021 she had 2-3 naps. Then on Monday, 01Mar2021 she was back to normal. The only things caller was concerned about was if she should get the second shot. She read about not getting the second shot if you had a fast heartbeat. She would call her doctor, but all the doctors are telling people to get the shot. The only reason she got it was because of her husband and his underlying conditions. No specify Antipyretic used around the dates of Vaccination. No relevant tests. The patient underwent lab tests and procedures which included Heartbeat: 107, 90s on 26Feb2021. Outcome of the event lymph nodes in the neck that made her hard to move her head was recovering; events palpitations, jaw pain up into eye recovered on an unknown date; event leg cramps recovered on 03Mar2021 and outcome for remaining events was unknown. No follow-up attempts are possible. No further information was expected.

getting lightheaded; Excessive hypertension/ 180/88 to 94; This is spontaneous report from a contactable nurse reported for herself. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 21Mar2021 (Batch/Lot Number: ER8727) as 2ND DOSE SINGLE for covid-19 immunisation. Medical history included hypertension, paroxysmal atrial tachycardia, stroke when she was 40, had COVID in Mar2020 (Her cardiologist believes she had COVID too but never did a test) and broke her ankle. Concomitant medication included warfarin sodium (COUMADIN) because she had a stroke and broke her ankle and got a clot from her ankle to her groin; ongoing diltiazem hydrochloride (DILTIAZEM HYDROCHLORIDE) taken for paroxysmal atrial tachycardia and hypertension; Chlorthalidone taken for polyuria and hypertension; verapamil hydrochloride (VERAPAMIL) taken for paroxysmal atrial tachycardia for years. Patient received first dose of bnt162b2 on 28Feb2021 in left upper arm. Patient was a retired nurse and stated about a month after the second dose of the vaccine she started getting lightheaded, she went to Urgent Care because her daughter who is a nurse insisted. Her blood pressure at Urgent Care was really, really high, she was having excessive hypertension. Before the vaccine she was on a blood pressure medication for several years and had no issues. She went to see her cardiologist and they moved her from one medication to 3 medications (then add Losartan, Diltiazem) to get this controlled. In the morning she was lightheaded and her blood pressure is high before her morning medication. Diltiazem is 24 hours. She gets up at 3AM and once she takes the medication it seems to be ok. Her blood pressure is reasonable now. It is not like it was initially when elevated. Initially it was 180/88 to 94 when she first went to see the cardiologist after second COVID19 Vaccine. Currently her blood pressure in the morning is usually 154/ 77. That was when she first takes it when she gets up. Later in the morning it is running 110/77. The event outcome was unknown. She was feeling that it had to do with the second injection. Patient considered it was medically significant for high blood pressure and lightheaded, and considered both events related to COVID19 Vaccine.; Sender's Comments: Based on the known drug profile, there is a reasonable possibility of casual relationship between the drug BNT162b2 and the events Dizziness and Hypertension. 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.

major bleed; GI bleed; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 25Feb2021 (at the age of 77-year-old) (Lot Number: EN6200) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Medical history included first time she experienced bleeding was in 2013 because of aspirin. Stated that she decided it was a good idea to take baby aspirin so she took it on her own. She was told don't ever take aspirin ever again and she didn't have any problem until Nov2020. That was the first incident, in 2013, that told her she should not take blood thinner. They took her off the blood thinner in Nov2020. She had been taking aspirin. She lost half her blood; she lost it two settings. She sat down to take a bowel movement and was told she lost half of her blood. Not sure when she started Aspirin but she stopped it in 2013. It was mentioned that she could take aspirin. She was on a low dose of Eliquis for atrial fibrillation for prevention of a blood clots or heart attack. she had bleeding in the last year. The one that was the most was back in Nov2020; it was more pronounced. Mentioned that she went in on 12Nov2020 for the bleeding and then had to go back in because her legs were swelling. She stopped taking Eliquis in Nov2020 and from then until Apr2021 she had no bleeding. It was several years ago when she was diagnosed. She was riding her bike in the neighborhood, and felt too tired so she stopped at the doctor and went in and told them she felt weird, they couldn't get her BP and took her to the hospital and her heart rate was sky high like 250. They said she might had to have electric. She didn't have any pain but states she was psychologically freaked out by everyone running around. Mentioned that, she was first placed on dronedarone (MULTAQ) 400mg twice daily to treat her atrial fibrillation; she can't remember the year. After taking it as prescribed for some time she got atrial fibrillation again. She was told by the doctor it had lost its efficacy. Concomitant medications included Fenofibrate taken for blood cholesterol, Metoprolol succinate taken for blood pressure, Vitamins NOS, Ferrous Sulfate taken for anemia, Vitamin D3 all are ongoing. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: EL3246) on 06Feb2021 in arm left for covid-19 immunization. It was reported that, On 25Feb2021 she received her second dose of the Pfizer-BioNtech Covid-19 vaccine, on 19Apr2021 she had a major bleed and GI bleed (Hospitalization) on 19Apr2021. The patient was hospitalized for major bleed and GI bleed from 19Apr2021 to 21Apr2021. Outcome of the events was unknown. No further information expected.

Horrible feeling; Blood pressure goes high; Joint hurt; Fever/ very low temperature; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A 77-years-old female consumer (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient previously took tylenol as per her common sense and epipens (double dose) for swollen mouth and lips (due to a cleaner) two months ago. Concomitant medications were not reported. As per the description, it was reported that the patient was scared because she didn't had anyone. She was hesitated to get a vaccine. She experienced some reactions after her 2nd dose of the Pfizer vaccine. Her joint hurt and she was in a bad situation. She had a very low temperature than the normal temperature, blood pressure was high when she got upset. She was very angry that she had fever and had nobody to ask a question. She reported that no one told her about a high fever (100.4) or to go to the hospital. She said it was not worth it for her to get a fever. She reported the information on the paper was very vague and not clear, she felt horrible as she suffered and wanted to let know. She wanted to complain that the temperature of fever was not written and none of those were approved. She was asked to contact her local doctor. That was the most horrible experience for her. The patient underwent lab tests and procedures which included blood pressure measurement as high, body temperature as and 100.4. The outcome of all the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

2/22/2021 - Tested positive for Covid 3/9/2021 - found down at her SNF, taken to ER. complains of lower back pain, left hip pain, bilateral knee pain, low O2 sat Dx: Aspiration pneumonia of both lower lobes (HCC), *Left lower lobe pneumonia, History of COVID-19, Urinary retention, Diarrhea C diff negative. 3/22: placed on palliative care after speaking with family 3/23: Expired

Started with left hand being useless, then shaking. Shaking moved up to elbow. She tried to take off her sweatshirt and her arm froze--this is the last thing she remembers. Husband called 911 and she went to the ER. She had had a seizure and they found 2 brain lesions. She had a CT scan and an MRI in the ER. There was memory loss in the beginning and slurring of words. She felt a weighty fatigue. Was put on Keppra for seizures. Had consults with neurology, a neurosurgeon, a neuro-oncologist--all unsure of what exactly these brain lesions were. Back left lower part of brain: a small lesion, which was basically ignored Right side, towards front, part of brain, on top of and/or intertwined with motor strip: not sure what this is, a stroke or tumor (the neurosurgeon and neurologist had differing opinions) 2/22--1st MRI--shows 2 spots between these 2 MRIs the bloodwork, CT scan, and ultrasound are done--results normal 3/23--2nd MRI--larger lesion is bigger. Was not thought to be a cancerous tumor 4/23--3rd MRI--Looks like larger lesion is improving. A scheduled brain biopsy is postponed 5/20--4th MRI--the small spot is almost gone and the larger spot is much smaller, about 1/8th the size of the February MRI. According to the neuro-oncologist, this was an atypical stroke.

Pfizer COVID Vaccine EUA Pfizer Dose 1 2/6/21 (lot # not listed) Pfizer Dose 2 3/6/21 (lot # not listed) COVID Positive 5/25/21 at PCP office (but negative upon repeat testing 5/25/21) 5/25/21: The patient is a 78-year-old female presents emergency department today after testing positive for COVID-19 at her PCP office, they recommended she present to ED to rule out pulmonary embolism. Patient has a past medical history significant for ESRD on HD Monday Wednesday Friday, hypertension, diabetes mellitus type 2, anemia of CKD, and osteoarthritis. Of note, the patient had her COVID-19 Pfizer vaccination series completed in February of this year. On arrival to the ED, the patient's temperature is 98.4° F, heart rate 68, respiratory rate 26, saturating 90% on room air with blood pressure 163/63. The patient did desaturate to 87% on room air when ambulating in the room. The patient's laboratory studies were significant for HGB 11.3, ESR 44, CRP 1.7, BUN 17, CR 4.80, UA: Proteinuria, trace hematuria, small leukoesterase, many bacteria, 11-30 pyuria, 1-3 RBCs and moderate squamous epithelial cells sent for culture. Blood cultures x2 obtained. Chest x-ray shows no acute cardiopulmonary findings. V/Q scan showed normal exam. EKG showed normal sinus rhythm. The patient was seen emergency department laying in bed. She reports worsening shortness of breath over the weekend and COVID like symptoms for the past week. She reports some dyspnea on exertion. She states she has been weak, fatigued, had some chills, and was seen by her PCP, who tested her for COVID-19 and she tested positive. This COVID-19 test is not and are records. The patient has had some desaturations less than 90% when she falls asleep. She wishes to be a full code. 6/1/21: She is admitted to the hospital, as mentioned above 0 repeat COVID test is negative. V/Q scan is reported as normal. She is started on dexamethasone 6 mg IV daily, along with IV antibiotics ceftriaxone Zithromax and Acapella. Pulse ox is monitored, oxygen is weaned off patient has been stable on room air and has been afebrile. Nephrology consult is requested, patient had hemodialysis as per Nephrology recommendations on Monday, Wednesday and Friday. Her blood pressures were uncontrolled, her home medications Coreg dose was increased to 37.5 mg p.o. b.i.d. and Procardia XL increased to 60 mg p.o. daily and blood pressures have been stable now. Patient did complain of weakness to ambulate, had physical therapy and occupational therapy evaluation. She is being discharged home today in stable condition for skilled nursing. She is off steroids now. Discharge plan is discussed with the patient.

I first lost my nail. It was unusual because there was no trauma to the nail. I was reaching for something across my bed, and I started experiencing radiating pain across my chest as well as pressure. I stayed very still and then it spread through my left arm and up into my shoulder, neck ear and jaw. I remained still and tried breathing the best I could. This lasted a minute or two and then it released and was over. About a month later, I was diagnosed with RSV which ran down into my lungs and soon my blood pressure was going up because my heart was working so hard to breathe. It was over 200/175 which is abnormal for me. I had to end up calling an ambulance because I was having trouble breathing. I was prescribed blood pressure medication, steroids, antibiotics, prednisone and oxygen. I was not allowed to get out of bed, I couldn't walk. They told me it would take baby steps.

My mother has had her share of health problems predominantly relating to her Afib diagnosis,however after every dose she experienced side effects that have set her back in ways that were completely new,loss of memory Sluring her words, really bad head aches leading up to the first and second stroke.She was able to drive live on her own had sweet and kind,funny personality now that is all gone. She is a shell of who she was and our family just simply misses her,I truly just wish that we would have had been warned of the possible risks to patients like her prior to getting the vaccine.No matter how small the possibility of adverse reaction.We would have chosen to keep her longer.

RIGHT ARM HURT THE NEXT MORNING. LEFT ARM HURT THE 2nd MORNING. A WEEK LATER MY BLOOD PRESSURE WENT UP ABOUT 40 POINTS AND I WENT TO DR AND HE RAISED MY BLOOD PRESSURE DOSE. THEN BOTH MY KNEE JOINTS SWELLED FOR A WEEK. THE SWELLING LEFT MY KNEES AND WENT DOWN TO MY ANKLE BONES. IT HAS BEENOVER A MONTH AND I CAN BARELY WALK.

Pericarditis S/S: actue chest pain or pressure, Chest pain made worse bu lying down, deep inspiration or cough, Pain Hx from 3 providers Patient presents for CP that started on Sunday night. Worse with inspiration states she feels like she has to breath shallow. Reports at 3:30 this morning pain was worse. Developed this retrosternal pleuritic chest pain late Sunday that has worsened over the course of the day yesterday and early this morning. She describes it as radiating up into her neck at times. No shortness of breath or cough. The pain encompasses a large area of her central chest which can radiate up the center of her neck. It is worse with deep breaths but not worse with walking. Initial Admit for Chest pain, developed A Fib during ED admission. Seen by Cardiology. Admitted 2/16-2/18. Neg CT pulm angiogram. Disch Diag including Cardiology 1. Pleuritic chest pain, 02/17/2021 2. Atrial fibrillation, 02/18/2021 3. NSTEMI (non-ST elevated myocardial infarction), 02/17/2021 4. Pleural effusion, bilateral, 02/18/2021 Pt readmitted 2/19/21. Troponin neg at that admit. D Dimer, Quantitative: 2.62 mcg/mL FEU Troponin I: <0.030 ng/mL BNP: 227 pg/mL Cardiology consult 2/20/21 called it pericarditis On 3/10/21 admitted for salicylate toxicity (on ASA for AFib) and ED provider stated that 2/16/21 admit for chest pain states that cardiology note at 3/10/21 stated the prior admit included diagnosis of pericarditis

Patient presented to the ED and was subsequently hospitalized for acute respiratory failure with hypoxia and pneumonia within 6 weeks of receiving first dose of covid vaccination.

Feeling tired. After about six weeks, rapid decline with COPD - trouble breathing and heart palpitations.

DX: Pericarditis onset 05/07/2021 Clinician description of chest pain: She now has some constant dull central chest pain and vague shortness of breath similar to her symptoms she had with her pericarditis. She is concerned this is either a reaction to the COVID vaccination or may be recurrent symptoms related to her recent pericarditis and concern for rheumatologic etiology. CT Chest showed Cardiomegaly and small pericardial effusion, similar to 1/4/2021. Mild abnormality of CXR may be baseline. Mild abnormality in ECG. Elevated inflammatory markers and normal troponin. As above this easily could be a flare of a prior diagnosis of pericarditis due to being on a prednisone taper. She is under the care of a Rheumatologist. Concerned this is either a reaction to the COVID vaccination or may be recurrent symptoms related to her recent pericarditis on a steroid taper and concern for rheumatologic etiology. S/S: Dyspnea pn exertion, acute chest pain or pressure onset 05/03/2021

Blood pressure spikes for 3 days starting on day 3 after the vaccine. Top number spiked to 180 for 3 days in a row.

Was exposed to a positive COVID person. On 4/4 pt. reported to the emergency department with cough, sore throat, fatigue, sinus congestion. Tested positive for COVID on 4/4. Chest x-ray done, diagnosed with pneumonia on oral azithromycin. On 4/7 pt. returned to the Emergency department via ambulance - she was hypoxic, weaker and more short of breath - O2 sats in the 70s. Received blood on 4/5 as well as monoclonal antibodies. Troponin elevated at 0.409, EKG showed inverted T-waves.. Patient transfered to hospital.

she couldn't breathe very good and her heart started racing; she couldn't breathe very good and her heart started racing; Just didn't feel good; Tired; Felt queasy; Dizziness; blood sugar was low; Sore Left Arm; This is the spontaneous report from a contactable consumer. This 77-year-old female consumer reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6201 and expiry date: 31-May-2021) via an unspecified route of administration on 24-Feb-2021 at 08:15 in left arm (77-year-old), as dose 2, single for COVID-19 immunization. Medical history included of the patient included a dental surgery. When she got up in the morning her face was real puffy and she thought she looked like the Pillsbury dough boy. Both cheeks were swollen. This surgery was to remove a tooth. She stated that she took her premedication before her oral surgeon appointment. She previously had a kidney replacement and a shoulder replacement. She always takes pain meds before she does any dental work. She had blood pressure measurement, depression, knee arthroplasty, shoulder arthroplasty, thyroid atrophy, renal failure, coronary arterial stent insertion, hypothyroidism and steroid therapy. Concomitant medications of the patient included sertraline taken for antidepressant therapy, levothyroxine taken for hypothyroidism, potassium citrate taken for renal failure, atorvastatin taken for coronary arterial stent insertion, hydrochlorothiazide taken for blood pressure measurement, prednisone taken for steroid therapy from 27Jan2021 to an unspecified stop date; amoxicillin taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9265 and expiry date 31May2021) via an unspecified route of administration on 02Feb2021 in left arm (77-year-old), as dose 1, single for COVID-19 immunization and had no problems. It was mentioned that additional vaccines administered on same date of the pfizer suspect were reported as none. On 25Feb2021 the patient experienced sore left arm. On 28Feb2021 the patient did not feel good, tiredness, felt queasy, dizziness and blood sugar was low. So she had some orange juice and went about her day to grocery shop, so she laid down to take a nap and then felt okay. On 01Mar2021 she could not breathe very good and her heart started racing. Caller reported that she did not get clammy and that was why she did not feel it was hypoglycemia. She has not had that for years as she watched and made sure she does not eat too many carbs. She was tired and took a 3 hours nap. Caller states the whole time she just did not feel herself, but she just went on and pushed things aside as she had a life to live. She did not relate it to the vaccine at first. She got out her information paper and she had all of the symptoms that were on the paper besides the rash. The patient did not require emergency room and physician office visit. On an unknown date in 2021 breathing difficult, Heart racing, Feeling unwell, Tired, Felt queasy, Dizziness, blood sugar was low recovered. On 27Feb2021 sore left arm recovered. Caller would like to know if it is typical to experience side effects four days after receiving a dose of the Pfizer vaccine. Caller stated that she was home when she experienced the side effects and felt like a wet noodle and just wanted to lay down and did not seek medical attention. Caller did not clarify what the other number was that she had called and was directed to Pfizer DSU, but stated she had not made any reports previously. Caller does not have an email for her doctor at this time. She said she has not called him. She felt sick yesterday. Her cousin wanted her to go to the hospital but she said she can not do it as she could not breath good and just wanted to lie down. She was so weak. Caller mentioned that she was a little chubby, but she exercises and moves around a lot. Caller stated that she was not feeling good but went on because she has a life to live and go on with things. Caller stated she was taking Prednisone when she received her second Covid vaccination and she wondered if that had anything to do with her reaction. The patient took Excedrin Migraine for headache took Saturday, caller was unaware of dose she took. She stated that it was just over the counter. The Excedrin Migraine expiration date 21Dec and Lot SP2W, but she stated that she usually just takes Tylenol. Caller Mentioned taking normal vitamins daily and I Caps, she stated she feels like she does well for her age, and then restated that she does Damn well for her age. Caller states her family has heart disease issues during Vaccine supplemental form but continued to stated that she does not feel that was relevant to this report. Follow-up attempts were completed. No further information was expected.

Was exposed to a positive COVID person. On 4/4 PT reported to the emergency department with cough, sore throat, fatigue, sinus congestion. Tested positive for COVID on 4/4. Chest x-ray done, diagnosed with pneumonia on oral azithromycin. On 4/7 PT returned to the Emergency department via ambulance - she was hypoxic, weaker and more short of breath - O2 sats in the 70s. Received blood on 4/5 as well as monoclonal antibodies. Troponin elevated at 0.409, EKG showed inverted T-waves.. Patient transfered to Hospital.

Elevated blood pressure; swelling in mouth/lips; Nausea; Sensitivity to sound; Severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils); This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0140), via an unspecified route of administration in the left arm on 20Jan2021 at 10:00 (at the age of 77-years-old), as a single dose for COVID-19 immunisation. Medical history included spinal stenosis, degenerative disc disease, arthritis, sciatica, high blood pressure, diabetes, high cholesterol, pollen allergy, dust allergy, ragweed allergy, carageenan allergy and fruit allergy (tomatoes). Concomitant medications included morphine sulfate (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and metoprolol succinate (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously took simvastatin on unknown date for an unspecified indication and experienced drug allergy. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 22:00, the patient experienced swelling in mouth/lips, severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils), nausea, sensitivity to sound and elevated blood pressure. It was unknown if therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling in mouth/lips, severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils), nausea, sensitivity to sound and elevated blood pressure were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Rapid heart rate and pain in upper chest for about 15-20 minutes. Called 911, they gave two EKGs which appeared to be normal.

Patient was unresponsive in her room during the night, had gotten the vaccine this morning, 911 called. Had right arm pain and loss of consciousness. EMS got 180/104 BP and blood glucose was 122. Was transported to hospital. Returned to the facility the next day with no complications, was just fatigued.

Patient stated she has had anaphylactic reaction to a flu vaccine a couple months ago. Patient stated she spoke with her physician and he still recommend her to receive the COVID-19 vaccine today. Discussed premedication; however, patient stated that doesn't work. Patient was observed for 30 minutes. After that time, patient stated to the observer , RN her left arm "hurt all the way down" and "chest felts heavy". Encouraged patient to go to ED, but patient declined. Nurse assessed patient who then felt short of breath. , RN took patient, via wheelchair, to ED. Husband was with patient. ED triage took patient back and husband checked in patient.

Patient stated she has had anaphylactic reaction to a flu vaccine a couple of months ago. Patient stated she spoke with her physician and he still recommend her to receive the COVID-19 vaccine today. Discussed pre-medication; however, patient stated that doesn't work. Patient was observed for 30 minutes. After that time, patient stated to the observer RN her left arm hurt all the way down and chest felts heavy . Encouraged patient to go to ED, but patient declined. Nurse assessed patient who then felt short of breath. RN , took patient, via wheelchair, to ED. Husband was with patient. ED triage took patient back and husband checked in patient.

Admitted to hospital 1/14/2021 with acute mental status changes, hypoxia, pneumonia (previous positive COVID 12/18/2020) ICU 1/14/2021-1/16/2021, currently hospitalized PCU level of care

Progress Notes (Physician Assistant) ? ? Family Medicine Cosign Needed Expand All Collapse All Date: 1/25/2021 Subjective 78 y.o. male who was seen today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience dizziness. He denied difficulty breathing and difficulty swallowing. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to hypotension and rapid progression of symptoms. Patient ate a bowl of oatmeal this morning prior to receiving his vaccine. He has only drank a small amount of diet coke today, no water. He became dizzy when standing up and some while walking. He notes the dizziness resolved on his walk to the medical evaluation bay. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness Patient denies chills, fever, facial swelling, chest tightness, shortness of breath, wheezing and headaches Previous Reactions: Denies Objective Vitals Vitals: 01/25/21 1150 BP: 133/86 Pulse: 84 SpO2: 97% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Assessment/Plan Treatment included: water Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Patients symptoms of dizziness completely resolved prior to discharge. He denied dizziness when standing up and walking to leave the medical evaluation bay. Electronically Signed 1/25/2021 12:02 PM

This is a spontaneous report from a contactable consumer who reported for herself. A 78-year-old female patient received her single first dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine, lot number EL3246), at right arm, 17:00 on 08Jan2021 for Covid-19 immunization. The patient's medical history included hyperlipidemia, hypothyroidism, osteopenia, skin cancer, osteoarthritis right hip and had known allergies to zocor, lipitor, latex, fluorouracil, imiquimod, travis. The patient normally had low blood pressure and pulse. Patient had no Covid-19 prior to vaccination. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) and pravastatin sodium (PRAVASTATINE SODIUM ACCORD). Patient had no other vaccines within four weeks. 08:00 on 10Jan2021, the patient had increase in B/P, pulse, and developed headache and light headed. The patient had healthcare professional office/clinic visit. No treatment was received. The patient had not tested Covid-19 prior to or post vaccination. The outcome of the events was not resolved at the time of reporting.

felt tired; nausea; headache; short of breath; rapid/shallow breathing; rapid/shallow breathing; fast heart rate (100 bpm); low grade fever; felt very weak; pleuralpericardial effusion; pleuralpericardial effusion; This is a spontaneous report from a contactable consumer. A non-pregnant 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm on 16Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included allergic to opioids, allergy to fish, cirrhosis with portal hypertension, parkinsonism, heart blockage, type 2 diabetes, depression, early dementia. The patient previously took morphine and experienced drug hypersensitivity. There was unspecified concomitant medication. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced allergic to morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced felt tired, nausea, headache, short of breath, rapid/shallow breathing, fast heart rate (100 bpm), low grade fever, felt very weak, pleuralpericardial effusion on 16Jan2021. All the events were reported with the seriousness criteria of disability, hospitalization and being life-threatening. The patient was hospitalized for the events for 4 days. After the injection, from 0 to 24 hours the patient felt tired, had nausea, a headache, short of breath then at about 24 hours post injection developed rapid/shallow breathing, fast heart rate (100 bpm) low grade fever and felt very weak. The patent was taken to the emergency room (ER) at 30 hours post injection and it was determined (Xray, CTA & EKG) that she had a pleuralpericardial effusion. She was flown by air life to another ER for treatment. The patient underwent lab tests and procedures on 16Jan2021 which included angiogram (CTA): had a pleuralpericardial effusion; body temperature: low grade fever; electrocardiogram (EKG): had a pleuralpericardial effusion; heart rate: 100 beats per minute (bpm); X-ray: had a pleuralpericardial effusion. The patient had a rapid nasal swab on 17Jan2021 which was negative. Therapeutic measures were taken as a result of the events and included unspecified medications & oxygen therapy. The outcome of the events was recovering. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Patient reported that after a couple of hours of receiving the covid vaccine, she became dizzy, nauseated, and lightheaded. She reported her blood pressure was low 80/60 and her heart rate about 100. She rested and her pressure came up. Then she reported a couple hours later she felt that way again while walking around house. She sat down and felt better. Then around 6p symptoms came back and she also had a headache and a little shortness of breath. She then decided to go to the ER.

she had a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest; Chest tightness; like she was going to faint or go to sleep; like she was going to faint or go to sleep; she barely had a little pain at the COVID-19 Vaccine injection site that went away quickly; This is a spontaneous report from a contactable consumer, the patient. This 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), dose 1 , single dose via an unspecified route of administration in the left upper arm on 08Jan2021 at 09:15 AM (at the age of 78 years-old) for COVID-19 vaccination. Relevant medical history included ongoing high blood pressure in Dec2020. Concomitant medications included valsartan (DIOVAN) 160mg tablet, once a day from 10Dec2020 and ongoing for high blood pressure and clobazem (CALM) from Jan2021, lot: 1115941, expiration: Mar2022. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 08Jan2021 at 09:15 AM, the patient barely had a little pain at the COVID-19 vaccine injection site that went away quickly. On 18Jan2021, the patient had chest tightness and a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest. She said it was like she was going to faint or go to sleep. She said the wave went down to her chest area and stayed for a big portion of the day. She said she had a heaviness in her chest, clarified as a chest tightness. She said she has no heart issues. The patient still had some tightness in her chest and it may be just from worry. She said she was normally calm, so she was not sure about what was causing her current chest tightness. The patient did not think what she experienced on 18Jan2021 was serious enough to contact her primary care doctor. There were no relevant laboratory tests done. The patient did not require a visit to the emergency room or physician's office. The clinical outcome of event, barely had a little pain at the COVID-19 vaccine injection site was recovered on an unknown date in Jan2021. The clinical outcome of event, wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head was recovered on 18Jan2021 after treatment was given. The clinical outcome of chest tightness was recovering after treatment was given. The clinical outcome of like she was going to faint or go to sleep was unknown.

About 7-10 minutes after receiving the shot, patient started to feel extremely shaky and warm. Her face turned red and hands were shaking. Patient felt her heart skipping with irregular heart beats. The nurse measured the patient's blood pressure and it was 183/95 with a pulse of 104. The patient was observed for an hour.

Approximately 10 minutes after receiving the COVID- 19 vaccine resident displayed seizure activity, staring straight ahead and strong allover muscle jerking of both the up and lower extremities, color became gray, activity lasted approximately 3 minutes, resident then became relaxed, color returned to normal, BP-140/80, 97.8, 60, 16, sleeping the remainder of the shift,. Resident continued to decline until resident CTB on 1/19/21

Immediately after receiving the vaccine had heart palpitations while sitting down for the 15 minute wait time. She thought it would be temporary and go away, but did not. She came home, and it was still happening, still having them. She talked to her daughter and went to the ER. They did an EKG and blood work for fear of having a heart attack, all was negative. Didn't do anything more for her. After 3 hours and moved to a chair and then it suddenly stopped. She did have this reaction for about 5 hours. Still feeling tired but not sure if it was from weather or stress itself.

AMS-Fever-UTI-myoclonic jerks-unresponsive <6hrs post 1st covid vaccine. AMS-UTI- post 2nd covid vaccine

double vision, little dizzy, headache - yesterday had her 2nd vaccine SYMPTOMS DURATION: 2 days. Patient states she got her first COVID vaccine on 2/5/21 and had a slight headache but no other symptoms. Today, she was sitting the car when she started to have double vision. She reports dizziness/lightheadedness that is moderate. Patient states the double vision isn't everything but random things and at random times today. Denies dehydration, fever, or injection site abnormalities. No headache today. Reports that last week at her PCP's office her BP was slightly elevated and she thinks her BP may be elevated right now but does not have a cuff with her to check. Went to the Emergency Department on 2.6.21 - admitted overnight until the 7th. DETAILS OF HOSPITAL STAY: DX: Diplopia [H53.2] Blurred vision, bilateral [H53.8] HOSPITAL COURSE: 1. Double vision post COVID vaccine. Unclear etiology or if related to vaccine reaction. Resolved. CVA ruled out. Could be migraine associated. Advised patient to talk to PCP about migraine prophylaxis and see ophthalmology as outpatient. 2. HTN 3. HLD Advised patient not to drive till cleared by ophthalmology Inpatient workup included myasthenia gravis panel which is still pending The patient is a 78-year-old right-handed woman who received her first Pfizer COVID vaccination February 5. This morning she developed double vision. Images were horizontal she does not know if they were binocular or monocular. She saw couple with 1 child and it appeared that they had 2 children. She looked at her son and saw 2 heads on 1 body. She saw 2 traffic lights. Each time she saw diplopia, it lasted for maybe 1 minute, and after blinking it went away. The double vision was not associated with headache, facial numbness or weakness, numbness or weakness in her extremities, speech change or imbalance. She recovered from each episode. She has had torn retina twice in each eye. Those were each associated with flashes of light in floaters. She did not have a fever today. She has never had double vision before. Review of systems: She admits to a history of headaches. She said she had catamenial headaches and sinus headaches.

Symptoms: c/o chest pain, lightheadedness, vitals WNL. Intervention: rest, reassurance - symptoms resolved.

I began feeling weak around 3:15 and was worse by 4 PM. Then I began having shivers but no temp. I felt weak and pulse raced as soon as I got up and walked around. Some aches and pains and malaise but I slept all night. Next day still felt poorly but no chills. Got a cold spell towards evening bu lasted about 1 hr. Some slight congestions that was relieved with a good cough maybe twice a day for another couple of days. That is all.

Around 3:50pm patient had complaint of heart jumping. Heart rate was initially 104, after 30 minutes rest, coached deep breathing, heart rate 90 regular. Patient was persistently uncomfortable and tachycardic and requested EMS evaluation. Responding EMS checked EKG, glucose, BP (etc) and released. Patient seemed to have moderate reaction to vaccine.

severe headache lasted almost 3 days High blood pressure with a racing heart on the third day I received a prescription from my cardioligist the next I lost my sense of taste as of 02/02/2021 (11 days) my taste has not returned

Felt faint and lightheaded thirteen minutes after receiving shot. Hypotension down to Systolic Blood pressure of 72. Became unresponsive; EpiPen used. Patient improved. Taken by paramedics to emergency department

Pt reported Heart palpitations apprx 3 days following 1st dose. Pt reports the episode last for apprx 2hrs

Few minutes post vaccination, after moving to observation area via wheelchair, the patient complained of dizziness. She took glucose tabs she had brought with her. Staff wheeled her to Triage # 1. Her eyes rolled back in her head and she lost consciousness. Staff (paramedics on site) transferred her to gurney and started compressions. AED placed, V- Fib was rhythm, Shock # 1 given, CPR resumed. Shocked again. Fire truck and additional EMT arrived on site and took over care. Epinephrine was given 3 times via intra-osseous route, Amiodarone given intra-osseous route. Additional defibrillation with on site AED for a total of 6-7 times. Patient had good chest rise with ambu-bag, no airway obstruction or peri-oral edema noted. Code called at 12:40 PM.

unconscious; no heart rate/heart was not beating; all of the sudden she stopped breathing and her heart stopped beating; COVID 19 test positive; act funny, kind of quiet and not talking which was unusual for her; pressure was 60 over 4; This is a spontaneous report from a contactable consumer (patient husband). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), via an unspecified route of administration on 28Jan2021 16:00 at single dose at left arm for covid-19 immunization. Medical history included kidney ablation (ablation on the kidney cancer 5 years ago), kidney cancer, blood pressure, neuropathy, pain, had a urinary tract infection 19Dec2020 and they saw the cancer came back, radiologist read the CAT Scan and said the size of the tumor 1.5 to 2.4. Concomitant medications included acebutolol for blood pressure taking for years, diclofenac for neuropathy using for 10 years, oxycodone for pain taking 19 years; all ongoing, and oxycodone hydrochloride (OXYCONTIN) for pain. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Family Medical History was none. The caller stated that he was not sure if the Pfizer COVID-19 vaccine could have given patient (his wife) COVID-19 or not. He also stated that when they received their vaccines the facility was very crowded as was the hospital when the wife was getting her blood work done so he was not sure when or where she contracted COVID-19. On 29Jan2021, patient was very busy running several errands including going to the hospital for bloodwork and a nuclear medicine injection as part of a work up for kidney ablation that the patient was supposed to have completed, patient was in the process of getting ready to have an ablation on her kidney and had the nuclear scan for her kidneys and then went to get a COVID test. After they got home, patient sat down at the computer and she started to act funny, kind of quiet and not talking which was unusual for her. So at about 1700PM the husband went in to ask her what kind of music she would like and he found her unconscious in the chair. He took her blood pressure and it was 60 over 4; with no heart rate; she was just barely breathing, he could tell by the way her mouth moved. He tried to breath for her, all of the sudden she stopped breathing and her heart stopped beating. He called (phone number provided) and they rushed her to the hospital, and the paramedics verified her heart was not beating and they started to do resuscitation. Then they finally pulled her out of the chair and put her on the floor and she started to breath. When they took her to the ambulance she was still not quite coherent; she didn't know what was happening. She was taken to the hospital emergency room and stayed there for 12 hours and they monitored her with an EKG and only saw one spike for 6 seconds. They discharged her on 30Jan2021 afternoon and she has been totally normal 100 percent since then. Since she had been home she had been doing well and has had no other events. Added patient had never had a heart problem before. Caller stated that he was not sure if this event was related to her receiving the vaccine or not. Now they had to stay in quarantine 10 days until 08Feb2021 since the COVID test given at the hospital on 29Jan2021 night when she went in was positive. Patient was scheduled to received the second shot 18Feb2021. Outcome of events unconscious, no heart rate, pressure was 60 over 4 was recovered on 29Jan2021, events started to act funny and stopped breathing was recovered on 30Jan2021, outcome of other events was unknown. The adverse events resulted in emergency room/department or urgent care, patient was taken to the ER and monitored for 12 hours but no admission. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect.

I was in A Fib; feel strange; felt like my heart was racing; I felt shaky; This is a spontaneous report from a contactable consumer (patient). This 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL963), via an unspecified route of administration on 26Jan2021 12:00 at single dose in the left arm for COVID-19 immunization. The patient medical history included borderline high blood pressure, high cholesterol, Hashimoto's, hypothyroid. The patient's concomitant medications included rosuvastatin, levothyroxine sodium (LEVOXYL), hydrochlorothiazide and lisinpro received within 2 weeks of vaccination. The patient previously took ezetimibe (ZETIA) and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. After sitting in recovery room for about 10 minutes following injection patient began to feel strange. Patient called the nurse on duty and said she felt like her heart was racing. The nurse took her BP and pulseox and administered a mini EKG. Then the nurse called the EMT on duty who gave patient a six leader EKG and said patient was in A Fib. Asked if patient had ever had A fib before, patient said no. Then asked if patient wanted to go to the hospital, patient said no. After sitting with the EMT for five minutes or so another EKG showed patient was no longer in A Fib. Patient felt shaky for the rest of the day, but is normal now. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. Outcome of the events was recovering.

Received Pfizer 1/22/2021. RNA+ 2/4/2021. S/S SOB, cough, confusion. COVID assoc. resp. failure, stage 4 lung cancer, COPD, HTN, former smoker. patient in hospice and died 2/10/2021.

After vaccine a feeling of something going thru my body. Got very hot and dizzy. Sat in chair and nurse took my blood pressure which spiked to 208. I was shaking and my heart was pounding. I was rushed to the emergency room. Put on IV, Heart monitor, lung x-ray and blood test. Blood pressure was still at 188 at 2:00 PM. Asked to leave at 3:00 PM, I still did not feel good but I needed to get home, because my husband was home my himself and very upset. I am his caretaker. My pressure dropped to 158 at 10:00PM I had bad headaches for 4 days and I still get them once in a while. I do not have high blood pressure, my blood pressure is usually between 120 - 130.

Very High Blood Presser---Concerned about a Heart Attach--Teeth Aching--Back Pain--Chest Pain--Feeling like a heavy object was on her chest or stomach--Pain from back moved to her sides.

Pt felt flushed, had a HA and was dizzy. Was taken to first aid and medic reported pt BP 200/99 several times. Pt transported to ER for high BP and dizziness

Patient received her vaccine on 2/2/2021 in the morning. She was observed for over 15 minutes and had no history of any anaphylactic reaction of any sort. She felt fine and went home. 2/15/2021 we were notified by her family that she had passed away on 2/7/2021 at home. The cause of death was stated as myocardial infarct secondary to coronary artery disease. We do not think it had to do with the vaccine administration. The patient had many comorbidities.

10 minutes after vaccination, patient noted onset of dizziness, feeling "strange", tingling in her left hand, and palpitations. At 15 minutes after vaccination, her blood pressure was found to be 200/84 LA and HR90 . O2 sat 98% on RA. T 98.2 F. Pt remained alert and in no distress, but continued to feel dizzy and unwell. Her repeat blood pressure was 184/84. EMS was notified and patient was transported to the emergency room.

On 2/19/2021, 78yr old female with history of asthma, diverticulitis, GERD, hiatal hernia, HTN, and hyperlipidemia was administered second dose of COVID-19 Pfizer vaccine 0.3mL in left deltoid (LOT # EN6201). Patient has several documented allergies including dextromethorphan (anaphylaxis), guaifenesin (anaphylaxis), olmesartan (itching), erythromycin (unknown), hydrocodone (unknown), atorvastatin/pravastatin/rosuvastatin (muscle pain), codeine (throat swelling), shrimp (hives, itching). Patient received first dose of COVID-19 Pfizer vaccine on 1/27/21 without any documented issues. Patient initially tolerated injection without incident and was sent for post-injection 15min observation. During 15min observation period, patient became dizzy, diaphoretic, nauseated, and unable to walk with steady gait, hypertensive and endorsed hives. EMS called and patient sent to ED. During initial presentation to ED, BP 180/80, HR 85, and 97% on RA. Patient given Benadryl 25mg PO and ondansetron 4mg IVP at 2055. 1L LR bolus given at 2059. BP lowered during ED observation (BP 160/80 on 2/20 at 0442). Acetaminophen 650mg PO given at 0442 prior to discharge. Patient discharged home in stable condition ~ 0500 on 2/20 with plan for patient to follow up with outpatient provider. EpiPen was not prescribed at discharge. No update to EPIC allergies noted at this time. Of note, reporter notes unable to check POC BG at clinic (glucometer unavailable). Patient has no history of diabetes, but noted that has similar "episodes" with low BG. EMS checked BG (POC = 144).

Patient admitted following a syncopal episode which was found to be likely due to dehydration, orthostatic hypotension, and post-operative pain after ORIF.

patient stated she had chest pain while in observation area, patient was alert and oriented, patient stated that she was nervous, emergency services were called and patient was taken to ED

Acute ischemic stroke on 02Jan2021; This is a spontaneous report from a contactable Healthcare Professional. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 at single dose for COVID-19 immunisation at the age of 78-year-old. Medical history and concomitant medications were unknown. The patient was not pregnant at the time of vaccination. Patient had Acute ischemic stroke on 02Jan2021; the patient was hospitalized, and she was treated for the event. On 01Feb2021, nasal swab resulted negative. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was recovering from the event. Patient has not tested positive for COVID-19 since having the vaccine. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information there is no evidence or argument to suggest a causal relationship between the reported event of ischemic stroke and BNT162B2 administration. Event occurred prior to vaccination.

At location, she felt fine during 15min wait At 3:30-4:30 Zoom call, she looked good, but said she wasn?t feeling great & was concerned due to chills & 4days headaches after 1st dose At 8:30pm she called with chills, 3 layers of clothes & bedwarmer on... said her teeth chattered & was trying to drink warm water to heat from the inside (hydration w/o cold water; said no more coffee) At 11:00pm she texted chills were over, she was expecting aches ?but would be asleep during them?... good attitude at the time At 2:19am she called, had fallen & couldn?t get up, said she called a friend to come help her ... said she?d tried to get up, but legs were numb... said she was dizzy when she fell, total dry mouth & had reached for water, but it spilled when she knocked into things when she fell. She wondered if she should call Fire Dept (but wasn?t making total sense). Her friend came, tried to help, but I think she decided to call 911 for help getting her up & wants EMTs to check her out. **She had fallen during Covid, went to ER & they gave fluids & she was ?good? for a week, but then dizzy & severe lethargy, same friend took her to ER & she was admitted (negative covid test at that point), but very large PE, thus heparin & then Eliquis (Dec 2020).

Patient passed away on 2/1/21 at the Health System. She was there for congestive heart failure (CHF) which had been a problem for her since contracting COVID-19 (symptoms began 10/29/20 and tested positive 10/30/20). She had been to see her medical provider several times after her isolation period as well as a few trips to the hospital for, what they called "CHF flare-ups". Her last hospitalization began on January 30, 2021. Her social worker reported on t1/31/21 that "she would likely be returning in another day or two".

In addition to the expected response such as fever, chilling, fatigue , for 24 hours, I had cardiac arrhythmias (PACs) lasting 1-2 hours on February 24, 25 and 26, 2021. No atrial fib but very frequent PACs which was highly unusual for me. No atrial fib since July, 2020. Also I think the expected response was for around 24 hours. I was in the bed for 36 hours and felt fatigued from February 21, 2021 through February 26, 2021.

Severe headache; Feeling unwell; Joint pains; Muscle pains; Difficulty breathing; Chest pain; Tiredness; She felt a "little bit of nausea, very slight"; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EL3302), via an unspecified route of administration in the left arm on 23Jan2021 11:00 at single dose for Covid-19 immunisation. Medical history included blood pressure abnormal, thyroid disorder and high cholesterol. Concomitant medications included levothyroxine, lisinopril and rosuvastatin. The patient experienced severe headache, feeling unwell, joint pains, muscle pains, difficulty breathing, chest pain, tiredness on 24Jan2021 and little bit of nausea, very slight on unspecified date in Jan2021. The outcome of headache was recovered on 24Jan2021; for difficulty breathing was recovered; for chest pain and fatigue was recovering; for other events was unknown.

I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; Blood sugar was very high; Blood pressure was very high; I had shingles on it; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 29Jan2021 (at 78-year-old) at single dose for COVID-19 immunization (Because she was of that age and she wanted to travel again). Medical history included ongoing Diabetic. There were no concomitant medications. Reason for no lot number of COVID 19 Vaccine, consumer stated, "It says Pfizer, EL9267, no 62, I am not sure now. Maybe I think it says 2, it's a 2." She woke up at 1 in the morning and started really scratching (31Jan2021) and it's really is pink red pumps (31Jan2021) on her stomach. It started to spread in the whole stomach, then over the breast and under the arm, around her back. She had the reactions. It was a total rash (31Jan2021) and red. She took her blood sugar, she was diabetic, her blood sugar was very high (Jan2021), then she took her blood pressure, her blood pressure was very high (Jan2021). She was all ready to go to the hospital because when you have a rash that's not good. But now 3 hours later her rash disappeared and she felt much better again. When confirmed if the consumer wanted to report the same or have some questions, consumer stated, that she have question, why did she get the rash after she had the COVID vaccine, she had her shot on Friday, Pfizer shot vaccine on Friday. She stated that she felt better, she only have a little bit in her back itching. But everything else it was so red, she meant she had shingles (Jan2021) on it. It's the hospital who gave her the shot. Due date for the next shot was on 19Feb2021. It was stated that she is Diabetic, she don't take any medication, she did it on her own and she is border lined. On lab work, consumer stated that every half a year she had a blood test. Regarding treatment, the consumer stated that she didn't take anything, she was wondering if she was allowed to take anti-histamine. The outcome of the event Itching and Redness was recovering, rash was recovered, while other events was unknown. Information on the lot/batch number has been requested.

felt fairly decent/feel bad; she "came down with covid"/test positive for COVID; she is kind of weak; her heart was racing; aching/aches; she ran a fever that got up to 101; cough; her arm got sore; allergies; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) on 15Jan2021 at single dose in left arm for COVID Prevention. Medical history included ongoing High Blood Pressure, she was diagnosed approximately 5 years prior to starting blood pressure medications in 1998. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN AND HYDROCHLOROTHIAZIDE) at 320mg/12.5mg, once daily, by mouth from 1998 and ongoing, amlodipine besylate at 5mg, once daily, by mouth at night from 1998, both for High blood pressure. The patient stated that she did not realize, but she must have been exposed to the COVID Virus, prior to getting her shot. She stated that on 15Jan2021, she went and got her Pfizer COVID shot, and that same day, by the time she got home, she was starting to feel bad and it went downhill from there. She mentioned that on the same day on 15Jan2021, she "came down with covid". She finally went in on 22Jan2021, and got tested, and she did test positive for COVID. The patient was tested Positive for COVID-19 on 22Jan2021. She did believe she was getting better. On 29Jan2021, she felt fairly decent, and today, she is kind of weak but she is assuming that will happen. She was scheduled to go back for her second dose on 08Feb2021, and she is wondering if there are recommendations about the second dose, for people who tested positive for COVID after having gotten the first dose. When queried for her PCP contact information, she stated that her head is not working really great and she feels stupid she did not have this information handy to provide. She states that the first week with her symptoms, she just figured she did have the virus. She had a cough but it never got down to where she had trouble breathing, and she just figured that her body had to go through, whatever it was going to go through, and as long as the patient felt like she was okay, there was not anything anyone could do, she just had to play it out. When she did finally go get tested, the doctor told her to get on Nyquil and Ibuprofen, so that is what the patient has been taking, and she feels like it has helped a lot. Before she saw the doctor, she was taking Acetaminophen, but the doctor told her to do the Nyquil and Ibuprofen, so that is what she has been doing. By the time she got home from getting her vaccine, her heart was racing. She took her blood pressure and it was okay at 125/73, and her heart rate was 72. She has high blood pressure and she takes two medications for that, so she took her night time blood pressure pill and the fast beating of her heart went away. The next day, she got to aching. She has had all different aches, and she ran a fever that got up to 101, and the rest of the time it was 100 or 99, but the fevers were not all day long, they would just come and go. Now she has had no fever in four or more days, and she is doing better. She does still have the cough, but she also has allergies so she does not know what is causing the cough. As far as the reaction to the vaccine, just her arm got sore. But she thinks she was exposed prior to getting the vaccine and just did not know it. she stated that the people took her temperature the day of the shot and she didn't have a temperature. She did not receive any other vaccines on the same day as the COVID vaccine. The outcome of fever was recovering, of cough and allergies was not recovered, of her heart was racing was recovered.

Patient's heart went out of rhythm and began to beat very rapidly; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient (weight: 71.21 kg, height: 168 cm) received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN6201) on the left arm, at single dose, on 17Feb2021, for COVID-19 immunisation. Relevant medical history included thyroid disorder and acid reflux (oesophageal), both from an unspecified date. Concomitant medication included levothyroxine, from an unspecified date, at an unknown dose, for thyroid disorder. On an unspecified date, in Feb2021, the patient's heart went out of rhythm and began to beat very rapidly. No treatment received. Blood test was performed on an unspecified date, in Feb2021 to check vitamin D level, B12 level and thyroid (unknown result). Post the vaccination, the patient has not been tested for COVID-19. Clinical outcome of the adverse event was unknown at time of this report.

PT received 2nd dose of Pfizer at 1730. PT presented with hives down her arms in the observation room and EMS was alerted at 1735. EMS took vitals, and PT refused Benadryl. PT presented with hypertension (NIBP 227/116) and hospital contacted by EMS. PT agreed to be transported to the Hospital. Medic arrived at 1805 and transported PT to ER.

Excessive shivering/shaking; weakening of lower legs; spiked high temp during the night into the next day. 102, finally lowered 48 hours later. Nausea; massive headache; complete body pain in muscles and joints, including jaws and eye sockets. exhaustion, fast hearbeat; no injection site swelling or pain. Reecovery within 72 hours, fatigue and nausea for another 12 hours more or less. I do feel it was worth it.

LTC Pharmacy was notified of a potential vaccine related hospital admission on 3/8/2021. The following information was gathered from discussion with RPH at Hospital. The patient received second dose of Pfizer COVID vaccine on 2/26/2021. The patient then had nausea, vomiting, and poor oral intake. On 2/27/2021, the patient went to the bathroom and while on the toilet, had a vasovagal event which led to her hitting the side of the face while falling. Patient was then taken to the hospital for evaluation. The patient does have a pacemaker but the cause of the event was determined to likely be due to dehydration. Lab work was performed and pertinent lab values include: potassium of 3.1, SCr of 0.8, and BUN of 13. The patient received potassium supplementation and IV hydration in the hospital. Patient was discharged on 2/28/2021. Of note, the patient does have a pacemaker and a follow-up appointment with cardiology to evaluate the pacemaker was scheduled upon discharge.

Patient presented to the ED on 3/9/2021 with symptomatic anemia. The patient has a history of this. The patient received PRBC and platelets.

Pain in left leg - outside 2/7/21 went to clinic 2/8/21 Given an ultrasound Diagnosis: Blood Clot (Dvt) Given immediate shot in belly And prescription for Eliquis Followed up with Dr. (internist) 2/11/21

Cerebrovascular Hemorrhage (Stroke), left occipital zone; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EK4176) at single dose, in the left arm, on 13Jan2021, at 15:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination. Relevant medical history included Sulfa allergy (Sulfonamide allergy) and drug hypersensitivity due to pethidine hydrochloride (DEMEROL) was reported as past drug event. On 03Feb2021, received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EN5318) at single dose, in the left arm, for COVID-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID) and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). On 18Jan2021, at 12:30 PM, the patient experienced cerebrovascular hemorrhage (stroke), left occipital zone. Hospitalization and treatment (stroke Center ICU care) were required (duration of hospitalization 4 days). Clinical outcome of the adverse event was recovering at time of this report. Post the vaccination, the patient has been tested for COVID-19 (Nasal Swab) on 18Jan2021 and resulted negative.

heart attack one week after 2nd dose of pfizer vaccine. mild. 3 days in hospital, now on long list of heart medications. She already is suffering from demensia and these heart medications cause her more confusion.

vaccinated 1/13. presented for COVID screening on 1/14 due to a + exposure. Test was +. Patient came to ED on 1/16 with weakness, congestion, poor appetite, coughing. Previous headache and sweating had resolved by the time she presented. Discharged with isolation instructions. Returned to ED late on 1/22 with " right-sided chest pain described as sharp constant 6/10 nonradiating pain localized to the right side of upper chest, shortness of breath with exertion since this afternoon. She does endorse subjective fevers, with associated increased coughing which is productive in nature, shortness of breath." Admitted to ICU early 1/23, transferred to Medical Center on 2/4/21.

On 02/22/2021 received Pfizer 2nd shot of Covid 19 Vaccine. Next morning, 02/23/2021 around 6am could not lift my head off pillow, the room and everything was spinning around. I called my husband and he tried to get me to sit up but i could not. He took my blood pressure and it was in the high 165+ so he called our neighbor who is a registered nurse, she took the blood pressure and now 179+ and kept going up and at 190+ she called 911 and they took me to the ER at the hospital, they took the blood pressure and it was 212. At the hospital it reached 237 but the dizziness was going away. I came home around 3:14pm. Follow up visit with my doctor on 2/26 and 3/15 by phone call going over testresults. Some of the tests given on 03/02 Electrocardiographics & Vascular lab. Then on 03/15 more test MRI and MRIA. Than on the last Dr. office visit on 03/15 all tests were clean. Before the last visit we did a lot of checking around with people we know (doctors and nurses) about what was going on and mentioned about the Covid-19 vaccine shot given the day before and they mentioned that people were getting dizziness and some vertigo also one we talked with was a nurse, who missed two days of work because she as dizzy the day after the vaccine. So I mentioned this to the Doctor who said he has heard the same thing. He said that this could have caused what happened to me

my heart started pounding, rate was 130-140; BP went to about 180/110; nauseated; This is a spontaneous report received from a contactable consumer reported (patient herself). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN6205), via an unspecified route of administration on 28Feb2021 11:30 in left arm at single dose for covid-19 immunization. Medical history included IBS (irritable bowel syndrome), migraine, and allergies: codeine, mushrooms, shrimp. Pregnant at the time of vaccination was no. Concomitant medication within 2 weeks of vaccination included atenolol; ergocalciferol (CALCIFEROL VIT D); esomeprazole magnesium (NEXIUM 24HR); methylcellulose (CITRUCEL); paracetamol (TYLENOL); atorvastatin (LIPITOR). The patient previously took the first dose of bnt162b2 (lot number: EL9264) on 07Feb2021 at 09:00 AM in right arm for covid-19 immunization. About ten hours after injection (28Feb2021 21:30), her started pounding, rate was 130-140, BP (blood pressure) went to about 180/110 and she became nauseated. This happened as she was sitting quietly watching TV. After about 15 minutes she called 911 and was taken to hospital. All events were reported as serious and resulted in emergency room/department or urgent care, hospitalization on 28Feb2021. The patient underwent lab tests and procedures which included nasal swab: negative on 01Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Treatment for events included Telemetry, ondansetron hydrochloride (ZOFRAN), prochlorperazine edisylate (COMPAZINE). Outcome of events were recovered in 2021.

she woke up dizzy; it was like everything was moving or shaking just a little bit, and it would drive someone crazy; her eyes felt like they were burning out of the sockets; she was tired the next morning; she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet; she was nauseated; temperature of 103; she broke out in a terrible sweat; she was weak as water; light headedness; high blood pressure; This is a spontaneous report from a contactable consumer via Medical information centre. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 27Jan2021 14:00 as single dose for covid-19 immunisation. Medical history and concomitant medications was not reported. On 27Jan2021 20:00 the patient experienced light headedness, she broke out in a terrible sweat, she was weak as water. On 27Jan2021 the patient experienced high blood pressure. On 28Jan2021 her eyes felt like they were burning out of the sockets, she was tired the next morning, she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet, she was nauseated, temperature of 103 (pyrexia). On 05Feb2021 she woke up dizzy and it was like everything was moving or shaking just a little bit, and it would drive someone crazy. The event high blood pressure was considered as serious (Medical significant). It was reported that she had the Pfizer COVID shot 2 weeks ago today. She had severe reaction to the shot, she didn't have it immediately she got the shot on 27Jan2021 and at 2 pm and at about 8 pm she was sweeping the floor and she broke out in a terrible sweat and after that she was weak as water and then started feeling lightheaded and her blood pressure was going up, she put cold rags on her head. She did not take temperature but she did take her blood pressure and it was like 198/something, she said she noted at 8:30 she took it again and it was 180/98 she started drinking water she thought she might be dehydrated and finally by 9:45 she got it down 148/58, she slept that night felt pretty good but she was tired the next morning, about 4 o'clock that afternoon the second day she felt wonderful she went to sleep at about 10 o'clock, but when the clock was striking midnight it woke her up and she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet she was lightheaded her eyes felt like they were burning out of the sockets, she was nauseated when she stood up so she took Tums and that took care of the nausea. She came in and took her blood pressure and that is when it was 194/90 the second time, she has a Rely On arm band and it said 205/98 and then she took it again and it said 235/117. She called the medic and he told her he thought she had a false reading but her temperature was 103 and before he left her blood pressure come down 180/70. Her heart rate was 86 the medic got ready to go her temperature came down to 102.2. On 05Feb2021 which was last Friday she woke up dizzy and light headed and but it was like everything was moving or shaking just a little bit, and it would drive someone crazy .On Saturday she took 3 Motrin that morning and Amlodipine 5 mg and 20 gm Omeprazole and she also takes 1 24 HR Allegra with Fexafenadine and her temperature was normal that day, all day it has been normal. On Sunday at lunch time she got light headed and was floating again and she checked her blood pressure and it was 183/77.She stated that her doctor recommended to get the second dose if she have no more side effects She plan on getting the second dose next Wednesday. Therapeutic measures were taken as a result of high blood pressure, she was nauseated and temperature of 103. The outcome of the events was unknown.

2/2/2021 red scaly skin rash dorsum right hand. Next day pinpoint hemorrhagic 2-4 mm sized lesions on palmar surface of fingertips and sides of fingers, 21 in all. Diagnosed as clots by cardiologist and dermatologist on 2/25.Gradual resolution and healing by 3/14/2021.

blood pressure sky high; blood pressure sky high; couldn't walk; almost having a stroke; little dizzy; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 (Batch/Lot Number: EN6202) as SINGLE DOSE for covid-19 immunisation. Medical history included atrial fibrillation, blood pressure high, asthma. There were no concomitant medications. No other products. They have not had any other recent vaccinations or started any new medications. Caller said she had her first dose of the Pfizer COVID-19 vaccine shot 25Feb2021, then two weeks later her blood pressure was sky high and she couldn't walk and she went to the emergency room and they said that she was almost having a stroke. She said she was admitted 11Mar2021 and stayed until this past Sunday which was 14Mar2021. She hadn't seen her primary care provider (PCP) yet she only saw the doctor at the hospital. She was supposed to go back on 18Mar to get her second shot, so she wanted to know if it was gonna be safe. Caller said that she has recovered, and when she came home, she was a little dizzy, but they gave her a medication for vertigo and right now she was ok. Outcome of the events was recovered in Mar2021.

her immune system since has not been the same and has been very deprived; her immune system since has not been the same and has been very deprived; wasn't feeling right; Dizzy; weak and very disoriented; weak and very disoriented; did not feel good; terrible headache and laid down right away; things started spinning/head spinning; Nauseous; Flu like symptoms; Flushed; very cold; chills; very cold; chills; Pain in arm; rapid heart beat; anxious; like something was going to happen; bathroom a couple times and felt week with the flu like symptoms, they were very bad; did eat something later yesterday, but food was flat tasting; didn't taste right; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262, Expiration date: Unknown) via intramuscular route of administration in left arm on 28Jan2021 10:00 as SINGLE DOSE for COVID-19 immunization in the clinic. Medical history included neoplasm malignant, chemotherapy, radiotherapy, immune system disorder (her immune system since has not been the same and has been very deprived) from an unknown date and unknown if ongoing. Concomitant medications included bee venom for arthropod sting. The patient experienced wasn't feeling right , dizzy, weak and very disoriented, did not feel good, terrible headache and laid down right away, things started spinning/head spinning, nauseous, flu like symptoms, flushed, very cold, chills, pain in arm, rapid heart beat, anxious, like something was going to happen, bathroom a couple times and felt week with the flu like symptoms, they were very bad, did eat something later yesterday, but food was flat tasting, didn't taste right on 28Jan2021 and her immune system since has not been the same and has been very deprived on an unspecified date. the first Covid shot yesterday at 10:00. They had her to sit for 15 minutes to make sure she was okay to walk. About 7-8 minutes she noticed she wasn't feeling right, dizzy, weak and very disoriented. She got up and didn't want to create a scene and started walking through the clinic and stopped to ask the receptionist to call her husband in the car. There was so many people so she just kept walking and luckily was able to get to car and told her husband she did not feel good. By then she had a terrible headache and when she got home she laid down right away. Then things started spinning and she was very nauseous and is aware that these things can happen with the vaccine. Had flu like symptoms like she never had before, but this was worse. She did not have a fever, but was flushed and very cold, chills. Her arm was not hurting until about 9pm and during the night she had a rapid heart beat, but not really. Was very anxious like something was going to happen and she tried to calm herself by taking deep breaths but does not know if that worked. Finally, after 3 hours she was able to go to sleep and did go to the bathroom a couple times and felt week with the flu like symptoms, they were very bad. When she got up today she was 60-65% better. She did eat something later yesterday and had thought the nausea was because she hadn't eaten all day long. The food was flat tasting and she know she has that whenever she has the flu where nothing tastes right. She clarifies she has that anyway since 16 years ago she had cancer and a strong dose of chemotherapy and radiation and her immune system since has not been the same and has been very deprived. Whenever she gets sick she gets deathly sick and has to be watched or she may have to get hospitalized due to weakened immune system. States some people say that the second dose is worse, is that true or is it the same feeling. If she feels like that with the second dose she may not get it. No further details provided. Mentions as the day goes on she comes around more. Has to get her glasses to see card given. No other vaccines given that day or 4 weeks prior. No problems with vaccines in past. The outcome of event her immune system since has not been the same and has been very deprived was unknown and other events were not recovered. No follow-up attempts are possible. No further information is expected.

I lost consciousness; hitting my head; bruising body; when I had my blood pressure taken it was over 200 landing me in ER overnight to try to get my BP down; suffering with Arrhythmia; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Feb2021 (lot number: EN6201) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), administered in the right arm on 01Feb2021 12:00 AM for COVID-19 immunisation and experienced achy body, tiredness, fever and chills. After the second vaccine early in the next morning (23Feb2021) around 3 am, the patient lost consciousness when retuning from the bathroom hitting her head and bruising body. She lay on the floor for approximately 15-20 minutes. She was ordered by her primary care physician to have a brain scan but when she had her blood pressure taken it was over 200 landing her in emergency room (ER) overnight to try to get her BP down. She was now on beta blockers and was still suffering with arrhythmia awaiting an appointment with her new cardiologist. She was hospitalized for 2 days due to the events. She had no COVID prior vaccination and has not tested COVID post vaccination. She has no other vaccine in four weeks. Therapeutic measures were taken as a result of the events. The outcome of the events were not recovered.

Trembling; muscle weakness; palpitations; light headed, dizziness; slight headache; This is a spontaneous report from a contactable other HCP. This 78-year-old female other HCP (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN6201) via an unspecified route of administration from 08Feb2021 at 1:00 pm to 08Feb2021 at 1:00 pm at single dose on right arm for covid-19 immunisation. Vaccine facility type vaccine was doctor's office/urgent care. The patient was 78 years old and not pregnant at the time of vaccination. Patient's medical history included hypothyroid, hypertension, elevated cholesterol, possible heart condition, obesity, known allergies: shellfish, MSG (dates unspecified). Concomitant medications included Losartan, hydrochlorothiazide, triamterene (Dyazide), Levothyroxine, Pravastatin via an unspecified route of administration from unspecified date to an unspecified date at unknown dose and frequency for an unknown indication. If other vaccine in four weeks: No. Patient experienced trembling, muscle weakness, palpitations. light-headed, dizziness, slight headache on 08Feb2021 at 01:15 pm. AE resulted in: Doctor or other healthcare professional office/clinic visit. If treatment AE: no, If covid prior vaccination: no, If covid tested post vaccination: no. The outcome of events was recovered on an unknown date.

Pt has allergic reaction w/ her 1st dose. She was in the middle of her graded COVID-19 Challenge (dose 2) under a physician's supervision. Pt just received 0.03ml (10% ) of full dose. Pt then started experiencing increased mucus in her throat, clearing of throat, and states that her ears feel weird about 11 minutes later. Her Vitals at this time were 168/78, 85 HR, 14Resp, 100% Spo2. 5 minutes later another set of vital signs were taken at 152/84, 86 HR, 16 resp, 95% Spo2. EPi 0.3 mg was administered immediately. Pt states that her throat feels better about 3 minutes later, but her chest still feels irritated. Her Spo2 was up to 100% at this time. Pt then stated that she is starting to feel shortness breath after using the bathroom. Pt is then transferred directly to the ER .

Patient complained of dizziness and presented with substernal chest pain and mild shortness of breath within 15-20 minutes after receiving COVID-19 vaccine. History of hypertension and non-compliance with antihypertensive medications. Relative reports patient also with possible history of stroke with no anticoagulation. Patient hypertensive initially with Systolic in 180s and diastolic in the 80s, upon onset of symptoms. Chest pain minimized within 10 minutes after blood pressure came down to the systolic level in the 170s. Ground ambulance called to transport to Emergency Department, but patient declined ambulance transport and was taken to ED by car with son-in -law.

Pt developed palpitations, headache, dizziness and nausea after receiving vaccine. BP 192/81, repeat 206/86. HR decreased from 106 to 90; regular rhythm and rate. O2sat 99 RA. Lungs CTA. Denies chest pressure, tightness, sob. Also reported throat discomfort; benadryl 25 mg po x1 given. Sent to ER.

rise in Cr; Developed decreased PO intake; mild acute kidney injury; pancytopenia; lymphopenia; thrombocytopenia; This is a spontaneous report from a contactable Physician. A 78-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 10Mar2021, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient had unspecified concomitant medications. The patient had the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for Covid-19 Immunisation. On 13Mar2021, the patient developed decreased PO intake, then mild acute kidney injury with rise in Cr and pancytopenia/lymphopenia/thrombocy topenia. The events caused hospitalization. Treatment for the events were IV fluids, Hematology consult. The outcome of the events was recovered. The patient had negative covid swab test on 12Mar2021.; Sender's Comments: Based on the narrative information provided, a causal association between the reported events and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

ER HPI: 78 y.o. female who presents with respiratory distress. Patient is transported to the emergency room via emergency medical services from local long-term care facility. Patient is unable to give any history due to acuity and severity of current condition. On arrival to the emergency room patient is in obvious distress she is hypertensive with a blood pressure of 74/51 she is tachycardic with a rate of about 140 she is tachypneic with a rate of the 29th at 30 her oxygen saturation on a non-rebreather are 82% and her temperature is 102.9°. FINAL IMPRESSION ICD-10-CM ICD-9-CM 1. Septic shock (HCC) A41.9 038.9 R65.21 785.52 995.92 2. Aspiration pneumonia of right lower lobe due to gastric secretions (HCC) J69.0 507.0 3. Acute hypoxemic respiratory failure (HCC) J96.01 518.81

symptoms, signs, time course, etc.) 78 yo female patient with PMHx of paroxysmal atrial fib / COPD / smoking / anxiety-depression / obesity / arthritis and prior bil PE in 2018 after knee surgery (anticoagulated with Xarelto) who presented to FH on 03/30/2021 with SOB x2 weeks. Of note she received her 2nd COVID vaccine dose on 03/05/2021 and since she has worsening SOB. Pt reported cough w/ yellow sputum prior to her admission. At urgent care, she was hypoxic with Sat 82%, therefore she was transferred to ED for further w/u. Lab w/u showed BNP of 1,074 and trop of 32. She was found to have a negative POC COVID-19 and PCR is pending. Bil venous Dopplers show acute occlusive DVT in the R popliteal vein above and below the knee w/ slow flow in the R fem vein and no DV IN the LLE. TTE on 03/31/2021 showed EF 65-70% w/ G2DD, mod-severe RV failure and severe pulmonary HTN, mod TR, and dilated IVC. Decision was made to CT chest w/ contrast despite renal function given high suspicion for PE. CT chest w/ contrast showed large clot burden PE w/ findings c/w R heart strain, a 12x9 mm lobulated nodule in the RUL concerning for neoplasm, increasing patchy infiltrates, and increasing R pleural effusion and new trace L pleural effusion. Patient required 12L O2 via NC. IR was contacted at but felt that patient was not a candidate for CDT or for IVC filter. Patient was transferred to ICU for further care. Patient received IV heparin per the PE Protocol from, Alteplase 40mg on 4/1, and was started on treatment dose of Eliquis.

Pt admitted on 4/5/2021 c/o roughly 4 weeks of just general dyspepsia and feeling like she had acid reflux. She reports that then progressed to some nausea and then vomiting and then some generalized right upper quadrant midepigastric abdominal pain. She also noticed that her skin was becoming yellow. She reports no changes in any of her medications recently she had her second COVID-19 vaccination on 2/14 and blood work on 2/ 8 consisting of liver enzymes/CMP was normal. she arrived severely jaundiced with severe transaminitis, hyperbilirubinemia and acute renal failure. ERCP revealed no gross obstruction and free flowing bile and sphincterotomy was done with no improvement in her blood work. she remains hospitalized and is being transferred for HLOC due to worsening condition REVIEW OF SYSTEMS:

Presented to ED with persistent cough X 1 week, some SOB. No obvious fever. ROS + for cough, shortness of breath and wheezing. BP 131/84 HR 107 RR 22. Admitted to general medicine floor on 2L O2 via NC, Rx with remdesivir + Dexamethasone.

Patient received her first Pfizer COVID-19 vaccine and began feeling throat tightness, SOB, chest tightness and itching about 15 minutes after vaccine. Patient was going to be observed for 30 minute due to history of anaphylaxis. Patient was given 0.3 mg epinephrine in left thigh and 50 mg benadryl IM in right deltoid at 17:06. VS before medications 174/73 HR 73 and after medications was 187/64 HR 78. Nitro patch was removed by Dr. prior to medication administration.

it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours; it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours; blood pressure went up to 198/203; still has tiredness; difficulty swallowing like her throat is still tight; difficulty swallowing like her throat is still tight; short of breath; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), first dose via an unspecified route of administration, administered in Arm Right on 11Mar2021 11:00, single dose for covid-19 immunisation. Medical history included silent heart attack, ongoing Barrett's oesophagus from 2008, fall she had over two months (2021), eye surgery on an unknown date. She does not get any shots and can't have shots even for the flu shot because she had problems with two flu shots she had; states she had a problem with each one of the flu shots and does not know the names of the flu shots and has no lot numbers to provide for them; states she had the flu shots in the early 1990's and worked in healthcare and had to have them and they told her back then if she wanted to work she had to have the flu shots and then she got sick with both of the flu shots and they said they guessed they would not force her to have the flu shots. The patient's concomitant medications were not reported. Patient had the first dose administered and then about 14 hours after (12Mar2021) that she had no problems until it began working up her arm with arm pain and chest pain which persisted and she went to the hospital and was admitted for 23 hours. She does not know what to do about getting the 2nd dose of the vaccine and was at her cardiologist's this week and he said he is not familiar with the Pfizer vaccine causing chest pain; caller states she has a history of silent heart attacks. She still has tiredness and difficulty swallowing like her throat is still tight and they told her to mention if she does go for the second dose of the vaccine to mention that she had this situation.The chest pain and arm pain began 12Mar2021 and the arm pain is in her right arm where the vaccine was administered and the arm pain and chest pain have resolved; states the arm pain and chest pain stopped and she thinks that lasted about an hour and a half and she called a family member to take her to the hospital; states about 2:30am that same day she was admitted the morning of 12Mar2021 and was discharged on 13Mar2021. They ran every test known to the patient and for a while her blood pressure went up to 198/203 in the emergency room (12Mar2021) and she is not on any medication; caller states she does have Crestor but has not started on it and has not taken it yet. The tiredness and difficulty swallowing like her throat is still tight began the same time she was having the chest pain and she is not having any chest pain or anything like that right now but the tiredness and difficulty swallowing like her throat is still tight is still ongoing; states she did go get cardiac clearance to make sure which was this past week and she does not feel well and like for her the tiredness is bugging her. The tiredness and difficulty swallowing are better but she knows they are there and she tries to swallow something and is like boy her throat is still tight. They did an ultrasound in her left leg because she was limping from a fall she had over two months ago but still has a sore ankle from that and they sent her down for the ultrasound and a CT looking for blood clots in her lungs because she was short of breath (12Mar2021); caller states she thinks they were running everything they could to rule out things; states everything was negative for the CT and ultrasound and she believes the CT and ultrasound were done on 12Mar2021. She has no idea when she was diagnosed with silent heart attacks but they kept asking her about this when she went in for eye surgery and asked her when she had a heart attack and she said she had never had one and they said yes she had and she never knew. She just set up a HCP appointment after the reported events with a gastroenterologist because she has Barrett's and because of the esophagus she did not know if it flared up by the Pfizer vaccine and that caused the pain because the two pains of the heart and esophagus mimic each other with pain going up into the jaw so they were ruling out which one it was; states she went out as an atypical chest pain and called the cardiologist and went in and went over her records from the hospital with the cardiologist. She does not know what caused what in terms of the pain. The outcome of the event blood pressure increased was unknown, chest pain and pain in arm was recovered, other events was recovering.

Pt reported sharp, pinching 2/10 pain in chest. Patient reported nervousness and a history of similar episode when stressed. Pt vitals assessed. BP 164/78, HR 56, 98% SpO2. Patient denied itchiness, rashes, hives, and difficulty breathing. Pt given water. Pt advised to stay for further observation. Pt reassessed at 1625. BP 162/78, HR 59, 97% SpO2. Pt denied difficulty breathing, itchiness, rashes, and hives. Patient offered transportation. Patient declined transportation. Patient left facility at approx. 1630 with steady gait and unlabored respirations.

3/17: dizzyness attributed to hunger, ate, went to bed. 3/18: unsteadiness walking, difficulty eating and speaking. Did not call 911/alert family. 3/19: symptoms continued. Daughter observed symptoms, including facial droop, and transported to local hospital ED. 3/20: discharged without seeing neurologist. CT scan and other tests failed to show stroke. However, MRI not performed. 3/22: outpatient visit to neurologist who, based on symptoms, concluded stroke had occured on left side of brain due to COVID 19 vaccine. 3/24: MRI performed and shows stroke. 3/30: MD orders additional tests. 4/1: admitted to Rehab. Hospital for 9 days.

passed out for a very short period of time; was awakened by total body shaking and it was not just shivers but was uncontrollable shaking; her body felt warm but then she was freezing; her body felt warm but then she was freezing; was sick and was different and very weak; muscles were sore; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE)), via an unspecified route of administration, administered in the left arm on 17Mar2021 12:10 (Batch/Lot Number: EN6207; Expiration Date: 31May2021) as a single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of the Pfizer BioNTech COVID19 vaccine on 23Feb2021 (lot number: EN6198 with expiry date 31May2021) for Covid-19 immunization. The patient experienced passed out for a very short period of time and awakened by total body shaking and it was not just shivers but was uncontrollable shaking on 18Mar2021; her body felt warm but then she was freezing, she was sick and was different and very weak, and muscles were sore in Mar2021. It was further reported that the patient got the 2nd dose of the Pfizer BioNTech vaccine that day on 17Mar2021 and about 12:45am or 1:30am the next morning she was awakened by total body shaking and it was not just shivers but was uncontrollable shaking; the shaking has resolved completely but she is not sure when it resolved but she was shaking for a good while because she can remember being so uncomfortable with her body moving so much which went on for maybe 20 minutes or so when her husband woke up.Patient's husband then woke up and got Ibuprofen and gave it to her and that stopped the shaking which surprised her and she did not know the Ibuprofen would work to stop the shaking that well and the Ibuprofen did work in stopping the shaking. The Ibuprofen stopped the shaking and she can remember to touch her body felt warm but then she was freezing and she does not know what this means but this was not ongoing and resolved when her husband gave her the ibuprofen and she stopped shaking right away which always amazed her that the Ibuprofen worked. She stated fortunately the Ibuprofen stopped her from shaking and she was able to sleep until early morning when she woke up and knew she was sick and was different and very weak; states the weakness was not ongoing and the approximate time the weakness resolved was unknown but she was down the rest of the day and after that she passed out for a very short period of time and held her head up and stood up and thought wow something was going on and asked where was this coming from and it was not nausea but she was just weak. She has not passed out for a huge amount of time but fortunately she had some towels laying close by and was able to use a towel; states after that she stopped for the rest of the day and only got up to go to the potty and was just so weak and heard that from many people that they just slept afterwards.Caller states her muscles were sore and she realized that was just normal and after the 2nd dose of the vaccine she knew her muscles would probably be sore and this was resolved. She came downstairs and was sitting on a chair and then stood and no longer sat in the chair and her husband knew things were not right with her and her eyes looked funny and she passed out and that never happened to her before and she was passed out for a few moments. Other than the Ibuprofen she did not have treatment and did not go to the emergency room or the HCP office. Patient only took one Ibuprofen and she has a very small body and her husband sometimes takes 2-3 Ibuprofen and she thinks wow that is so many but she herself does not have any medication and she just took one Ibuprofen and it worked; She took the Ibuprofen on 18Mar2021 in the early morning. Fortunately she was in good health. Outcome of the event passed out for a very short period of time, was awakened by total body shaking and it was not just shivers but was uncontrollable shaking and muscles were sore was recovered in Mar2021, and unknown outcome for the remaining events.

Patient had ED visit with leg swelling and pain that resulted in right mid femoral DVT discharged home from ED with apixaban.

After 5 minutes of receiving vaccine, patient became nauseous. Once home, she complained of dizziness. Around 4am, patient was awakened with strong heart palpitations. She noticed ankle and foot swelling after about a day. She also noticed a rash on the vaccine arm, neck and under chin. She experienced severe nausea and vomiting over the next 3 days and could not eat food. She did not seek medical attention and chose to stay in bed to recover. As of today, the patient says she is almost recovered from these events.

Altered mental state, memory loss, confusion, diagnosed as transient ischemic attack, most symptoms resolved in 24 hours

Acute headache radiating to neck and right shoulder and right eye. Acute hypertension with hypertensive crisis BP 223/113 needing Emergency department admission. Following this ED visit the the BP had been uncontrolled with ongoing headaches and right sided neck pain radiating to the right eye/head through March and in April have improved. During this time had #2 Pfizer vaccine 2/12/21 and had experienced arm pain and headache as well as a spike in her BPs as well as right sided neck pain radiating to her right eye

Patient received her first dose of Pfizer vaccine on 4/1/21. Patient has a stroke 4/6/21 and passed away on 4/10/21.

On 2/18/21, 10 days after receiving the vaccine, I donated blood as usual. About 30 minutes later I was light headed, had abdominal cramping pain, bowel emptying and possibly fainted. I was transported by EMTs to the ER and was later diagnosed with inflamitory bowel by a CT scan. I took antibiotics and was feeling fine. My gastroenterologist performed a colonoscopy on 3/24/21 and the findings were that I was healed and tissue samples were normal. 3/25/21 I had an annual physical and was told I was in good health. Later that afternoon I began feeling light headed upon standing. In the night I called my health insurance hotline because my blood oxygen meter was beeping continuously. The Dr. on call told me to go by ambulance to the ER. When sitting or lying down, I felt fine and all the tests at the ER for my heart and my vital signs were good. A few hours later, they did a hest Xray and then a CT scan of my lungs which showed a saddle embulism. I had also thought I had bruised my knee if and when I fainted on 2/18 and 1o hours later a blood lot was found by ultrasound of my left knee. I was given blood thinners in the ER and then in ICU where I spent the next night. I am now taking Eleris. I was also given pantoprozole for GERD coughing the next day. I continue to have periods of abdominal ramping/pain, light headedness in waves and pressure in my head. I have disontinued the stomach medication with some feeling better with the lightheadedness.

Post vaccine patient reports feeling raised heart rate. Pt was transported to med obs via wheel chair. Pt remained in wheelchair. Pt reports not feeling this way after her first vaccine . Per patient her BP is higher then usual . Pt didn't want anything to drink . Pt reported feeling better and was released at 11:30 with her grandson . Vitals as follow: 1114 BP 168/81 HR 67 RR 18 SpO2 96 1119 BP 157/80 HR 66 RR 20 SpO2 96 1124 BP 168/76 HR 67 RR 18 SpO2 98 1129 BP 158/75 HR 67 RR 18 SpO2 98

severe pain; joint pain; headache; fever; nausea plus heavy chest feeling; Have persistent cough; Heavy chest feeling; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 13:15 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation. Medical history included gastrooesophageal reflux disease. Concomitant medication(s) included vitamin d3 (VITAMIN D3) taken for an unspecified indication, vitamin b complex (B COMPLEX [vitamin b complex]) taken for an unspecified indication, fish oil (fish oil) taken for an unspecified indication, biotin (BIOTIN) taken for an unspecified indication, start and stop date were not reported; famotidine (PEPCID [FAMOTIDINE]) taken for an unspecified indication. The patient previously took covid-19 vaccine for covid-19 immunisation. On 15feb2021, at 18:30 the patient experienced severe pain, joint pain, headache, fever, nausea plus heavy chest feeling and have persistent cough. The patient was recovering from the events. The action taken in response to the event(s) for bnt162b2 was not applicable. No follow-up attempts are possible. No further information is expected.

nauseous; feeling unwell; Chest heaviness; Chills; Fatigue; her quality of life was low and getting worse everyday; Weakness; swollen lymph nodes in neck and groin; irregular fast heartbeats; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm right, on 01Mar2021 (Batch/Lot Number: EN6200), at single dose, for COVID-19 immunisation. Medical history included lymphadenectomy, thyroidectomy (in 2014 or 2017), COVID-19 from Feb2020 to an unknown date (not ongoing). Concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation (lot# EL9269) intramuscular in left arm and experienced vaccination site swelling and azithromycin (ZITHROMAX) and experienced drug intolerance and illness. The patient experienced weakness (disability) in 2021 with outcome of not recovered, swollen lymph nodes in neck and groin (disability) in 2021 with outcome of not recovered, chest heaviness (disability) on 07Apr2021 with outcome of not recovered, fatigue (disability) in 2021 with outcome of not recovered, her quality of life was low and getting worse everyday(disability) in 2021 with outcome of unknown, chills (disability) on 07Apr2021 with outcome of unknown, nauseous (disability) on 08Apr2021 with outcome of unknown, dizziness (disability) in 2021 with outcome of not recovered, feeling unwell (disability) on 08Apr2021 with outcome of unknown, irregular fast heartbeats (disability, medically significant) in 2021 with outcome of recovered in 2021. Therapeutic measures were taken as a result of the events and included treatment with 1 Baby Aspirin. The reporter (patient) considered all these symptoms she was reporting were disabling because she had no quality of life. No follow-up attempts are needed. No further information is expected.

Sundowning/sundowners; feel tired/Tiredness; headache on right side of head/not terrible, not like a hangover; Muscle pain/all over her body; chills; low temperature/was just a couple digits off; Joint pain/all over her body; during these days that she felt so awful she couldn't work her way through it; had a bad spell; felt bad; restless legs; felt unwell; tossing and turning, trouble sleeping; tossing and turning, trouble sleeping/did not sleep except for a couple of times; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199 and expiration date: Jun2021, via an unspecified route of administration, administered in right arm on 15Mar2021 as single dose for Covid-19 immunisation. Medical history included arthritis, diabetes, hypertension, rotator cuff repair, cancer (mom and dad both have passed from it. two uncles and grandparents have had cancer. cancer is pretty relevant in the family), alcoholism (mom and dad both have passed from it). Concomitant medication(s) included metformin taken for diabetes mellitus, metoprolol tartrate taken for hypertension, losartan potassium and lovastatin, ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). The patient stated that she was fine until a few days ago, 4 or 5 days ago she started to feel tired, headache on one side of her head, muscle pain and chills, low temperature, joint pain and just felt unwell. By the weekend the patient stated that she was down on the couch and her son was worried about her and suggested that she go to the hospital, which she refused. The patient described the headache as 'just there', states not terrible, not like a hangover. Since waking up today, she has not had a headache. She also added that she had trouble sleeping on Saturday night (03Apr2021). She stated she did not sleep except for a couple of times and she was just tossing and turning and took ibuprofen and it didn't help. The patient stated that the muscle pain and joint pain was all over her body. She had rotator cuff surgery on her right-side years ago and during this time she was carrying groceries on her own and her left shoulder started throbbing like the rotator cuff pain that she had in the past and she recognized it right away. She stated that she is not real sure if the muscle pain in her shoulder is a result of the vaccine or not. She has full of arthritis and was not sure if the pain is caused by the vaccine or not, but with her regular arthritis, if she has been sitting and gets up and walks around she is able to work her way through it, but during these days that she felt so awful she couldn't work her way through it. The patient stated that she feels like she has been suffering from sundowners but states she feels it's not related to COVID vaccine. She writes herself notes and forgets what notes mean. The patient was on hold so long with the first one. The patient had her first vaccination on March 15th and she am supposed to go back Wednesday April 7th for the second one. She had a bad spell for about 4 days last week. Today, she feel fine and have no temperature. She didn't have a temperature when she felt bad. The patient was having chills, restless legs, couldn't sleep. Now, the patient was feeling better. The patient recovered from the event headache unilateral, muscle pain, chills, body temperature decreased, generalized joint pain and feeling unwell on 05Apr2021, for events difficulty sleeping and restless was recovered on 04Apr2021. The outcome of other events was unknown.

Blood clots in Lungs; No longer able to do activities of daily living; Almost fell to floor from sitting position; short of breath; total body exhaustion/fatigue; sleepy throughout the day; unstable, weak; debilitating symptoms bedridden/unstable, weak; debilitating symptoms bedridden; passed out completely while sitting; Unable to complete daily 1 mile walk at park/Unable to take stairs; Lightheaded/dizzy; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 26Mar2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included patient had COVID-19 Dec2021 and recovered completely in 2 weeks. Symptoms: fever, sleepy. Went back to daily walk after 2 weeks. No loss of smell, no loss of taste, no mental changes- was very happy with my complete recovery. Took vaccine 26Mar2021 at recommendation of doctor to be safe from variants. Regret deeply, still hospitalized as of this writing. Concomitant medications included ramipril; rosuvastatin calcium 40mg; levothyroxine, all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulphur and experienced allergies. The patient experienced unable to complete daily 1 mile walk at park/unable to take stairs on 27Mar2021, lightheaded/dizzy on 27Mar2021, passed out completely while sitting on 28Mar2021, unstable, weak on 30Mar2021, short of breath on 31Mar2021, total body exhaustion/fatigue on 31Mar2021, sleepy throughout the day on 31Mar2021, almost fell to floor from sitting position on 09Apr2021, debilitating symptoms bedridden/unstable, weak on 26Mar2021, debilitating symptoms bedridden on 26Mar2021, no longer able to do activities of daily living on 13Apr2021, blood clots in lungs on 14Apr2021, all with outcome of not recovered. Reported adverse event: 27Mar2021 - Unable to complete daily 1 mile walk at park. Lightheaded, dizzy 28Mar2021 Dizzy, passed out completely while sitting. Revived and taken to hospital by ambulance 28Mar2021 Admitted to (hospital name withheld) 30Mar2021 Discharge from hospital - unstable, weak 31Mar- 08Apr2021 - short of breath easily. Unable to take stairs. Discontinued daily walk, weak, total body exhaustion, sleepy throughout the day 09Apr2021 - Almost fell to floor from sitting position. Patient's daughter lowered patient gently to the floor. Revived shortly 13Apr2021 Saw primary doctor Dr (name withheld). Shared her debilitating symptoms bedridden since Covid-19 vaccine on 26Mar. BP taken from lying down, sitting and standing was markedly different and explained caused passing out and lightheaded. No longer able to do activities of daily living 14Apr2021 - Exhaustion and fatigue, her daughter to her back to the hospital 14Apr2021 - Passed out in Emergency Room @ (hospital name withheld). Admitted. Blood clots in LUNGS. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for unable to complete daily 1 mile walk at park/unable to take stairs, lightheaded/dizzy, passed out completely while sitting, all from 28Mar2021 to 30Mar2021. The patient underwent lab tests which included blood pressure measurement: markedly different on unknown date. Patient was not pregnant. No other vaccine in four weeks.Patient had covid prior vaccination. No covid tested post vaccination. The treatment received for events included Heparin administered, still hospitalized as of now. Information about Lot/ Batch number has been requested.

Patient became faint after her waiting period and had to be moved by wheelchair to the medic suite. She was fairly unresponsive but did respond to verbal commands. She was assessed by the medic. Her respirations and blood pressure and pulse ox were normal, but she showed atrial fibrillation on the monitor. Called 911, and patient was transported to the Hospital by ambulance at 3:30 PM.

Tingling in arm, slight hypertension. EMS called and evaluated patient. Pt. refused transport, sx resolved

she just felt dizzy so fast and passed out; passed out; She hurt her ankle from it; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 08:45 (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, atrial fibrillation from Aug2020 and ongoing , cystitis. Concomitant medications included sulfamethoxazole, trimethoprim taken for cystitis from 27Mar2021 to 02Apr2021; apixaban (ELIQUIS) taken for atrial fibrillation from an unspecified start date and ongoing; atenolol (ATENOLOL) taken for Blood pressure from an unspecified start date and ongoing. The patient received first dose of bnt162b2 for COVID-19 immunization on 15Mar2021 lot number: EN6202, Expiry date: 30Jun2021. The patient received the second dose of the Covid vaccine around 8:45 a.m. and states that she "felt fabulous." On 06Apr2021 she felt fabulous. She said that she had a doctors appointment at 1200 06Apr2021 and her blood pressure was good. She said that she was also taking an antibiotic prior to that week. She asked the doctors about taking vaccines after taking the antibiotic since the medication said that you should avoid vaccines while taking the antibiotic, and they all said that it was fine. She came home about 1330 06Apr2021 and she passed out while making her lunch. She hurt her ankle from it and she is not a happy camper. She said that all her vitals were good and her blood was good. That was all taken 2 hours before she passed out. The weird thing was she never felt better that day after she passed out. She said that she had no reaction after the first shot. Prior to this she felt good and there was no warning, she just felt dizzy so fast and passed out. Caller said that her ankle is getting better and she hurt her toe too, but it is getting better. She treated the ankle with ice. She said that it could have been worse. She said that she did not understand this and had no side effects previously. The event passed out was assessed as serious (medically significant). The patient underwent lab tests and procedures which included blood test: good on an unspecified date her blood was good. Therapeutic measures were taken as a result of she hurt her ankle from it (arthralgia). The outcome of the event passed out was recovered with sequel on 06Apr2021, unknown for the other events.

Approximately 5 minutes after vaccine patient had a suspected stroke. Patient was in observation area and reported right side weakness, facial droop and slurred speech. Patient was attended to by EMS service and transported to a local hospital.

urgent continuous diarrhea, abdominal cramps, weight loss (5 lbs) in 3 days, dehydration, low blood pressure. clear liquid diet, blood pressure medications adjustment

Elevated troponin Essential Hypertension Abmulatory dysfunction Generalized weakness COVID-19 infection Hypomagnesemia

Diarrhea; several episodes of heart arrhythmia on two different days starting 10 days after second COVID-19 vaccine injection. Although I am predisposed to heart arrhythmia having been diagnosed with super ventricular tachycardia in late teen years, then atrial fibrillation starting at age 60, I was getting an episode of a-fib only once every 3-4 months following an ablation procedure. This was different as I had several episodes in a day on two different days. They subsided only following the taking of propafenone.

"Pfizer-BioNTech COVID-19 Vaccine" - received first dose 2/26/2021 and second dose 3/19/2021, admitted for acute segmental LLL PE. Pt endorsed subacute progressive DOE x6 months. Admitted to hospital with elevated BP and 2 weeks of progressively worsening SOB (after 3/19/2021, at which time pt received the second dose of vaccine.) EMS reported SaO2 79%. CXR - moderate diffuse edema or pneumonitis in both lungs, small pleural effusions, cardiomegaly CTA of chest - acute PE involving segmental pulmonary arteries to L lower lobe, moderate diffuse ground-glass opacities in both lungs (R>L) -- > possible drug-induced pneumonitis (lower suspicion because pt had been on palbociclib x2 years) or volume overload.

78 year old female client received her 1st dose of Pfizer Covid 19 Vaccine on her left arm at 11:20 AM Around 11:25 AM client reported seeing black. EMT and MD arrive to check on the client at 11:28 AM. Her vitals were 108/104 BP, 16 HR, 98% O2, 0/10 pain. MD gave patient water and gatorade she laid her down and elevated her feet. MD also instructed client to deep breath. At 11:36 AM client BP was 160/96. MD adviced patient to consult with her primary MD regarding of getting prescription for BP medications since patient is currently not on one. Client left on a wheelchair accompanied by grandaughter. Client reported of feeling better and not seeing black anymore

Sore at injection sight (mild) next day. Nothing noticeable until 24 Apr 21 Pounding headache, fatigue, sleepy long periods , mild sore throat, blood pressure lower than usual . Temperature with in normal limits . I have been resting a lot , waiting for conditions to improve, however, as of this writing nothing has changed. Thus I decided to file this report. my I have not seen my healthcare provider yet but will make contact tomorrow

Patient experienced an arthritis flare after the 1st dose, and this became much more intense after the 2nd dose. She had increased weakness, abdominal pain, loss of appetite (not eating/drinking much), falls, and failure to thrive x3 weeks after the second dose which all ultimately got her admitted to the hospital (4/6/21). Upon admission, her blood counts were found to be dangerously low.

after vaccination, patient began to feel lightheaded and dizzy, experienced syncope. after waiting for about 15 minutes she began to complain about chest pain. We decided to call 911 as she was extremely agitated and tremors

This 78 year old patient received the Covid shot on 2/27/21 and went to the ED on 3/1/21 with the following diagnoses listed below. Thrombocytopenia, unspecified

Non-ST elevation (NSTEMI) myocardial infarction Facial weakness NSTEMI (non-ST elevated myocardial infarction) CHEST PAIN CEREBROVASCULAR ACCIDENT

high D-dimer test result (485); rapid heart rate; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via unspecified route of administration on 11Feb2021 08:30 AM in left arm as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no known allergies. Concomitant medication included (other medications in two weeks) lisinopril, simvastatin, fluticasone propionate, salmeterol xinafoate (ADVAIR), ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any COVID prior vaccination. Since the vaccination the patient was not tested for COVID-19. The patient experienced rapid heart rate on 14Feb2021, high D-dimer test result (485) on 15Feb2021 at 7.00 PM. The patient did not receive any treatment for the events. The AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered on an unknown date in 2021. Information on the lot/batch number has been requested.

harder to breathe; smell of food made me sick later that day; blood pressure went down; cold chills; Shaking; This is a spontaneous report from a contactable consumer (patient reported for herself). A 78-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982) administered in left arm via an unspecified route of administration on 27Feb2021 at 10:00AM as SINGLE DOSE for covid-19 immunization. Medical history included arthritis, known allergies to sulfa and Tetanus shots. The patient's concomitant medications were not reported. The patient previously took first dose of historical vaccine of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported) via an unspecified route of administration on 06Feb2021 at 10:00 am as SINGLE DOSE for covid-19 immunization and experienced no adverse event. Other historical vaccine in 4 weeks included Prolia on 21Jan2021 in doctor office. On 28Feb2021 at 12:30 am, the patient was harder to breathe, smell of food made me sick later that day, blood pressure went down, cold chills and shaking. The patient reported as Shaking was so hard as she could not hold glass of water or get the pills out of the bottle because they flew all over the place. This lasted for 2 hours. Then smell of food made the patient sick later that day and then with the cold chills. It took heating pad and other heating products to stop from shaking. patient blood pressure went down to 98/60 and harder to breathe for just a short time. Treatment received for the event shaking and no treatment received for other events. The outcome of the events was recovering. No follow up attempts were possible. No further information was expected.

VS 141/83 mmHg, 98 bpm, 95% RA Around 15 mins after receiving vaccine, pt stood up and felt dizzy/near syncopal, no hives, itching, swelling, SOB, HA, CP or numbness Heart rhythm, swelling, SOB, HA, CP or numbness Heart rhythm regular, no murmurs, lungs clear to auscultation. No cyanosis. Resting tumor history Pt says history of breaking out in hives after getting a shot of "something" Despite rest, giving water and putting pt in Trendelenburg position still felt unstable gait/station with standing

Patient stated she developed clots during hospital admission with the complaint of chest pain. Patient stated at hospital admission, they discovered blood clot in her right leg and right lung. Patient was treated with oxygen and medication. Patient was inpatient for two nights and sent home lovenox injections for one week and continuing with Eliquis. Patient is currently on Eliquis for unknown duration. Patient will see cardiologist in three weeks and reevaluate.

numerous blood clots below the knee; left leg swelling/ It got so swollen/left foot swelling; pain with walking left leg; This is a spontaneous report from a contactable nurse reporting for herself. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Right Arm on 24Feb2021 (Batch/Lot Number: EN6202) as single dose for covid-19 immunisation (Age at vaccination 78 years). The patient medical history was not reported. On 04Feb2021 the patient received the first dose of BNT162B2 and experienced sore arm. The patient's concomitant medications were not reported. The patient experienced pain with walking left leg on 28Feb2021 with outcome of recovering , left leg swelling/ it got so swollen/left foot swelling on 03Mar2021 with outcome of not recovered , numerous blood clots below the knee on 04Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included blood test: unknown results, ultrasound joint: numerous blood clots below the knee on 04Apr2021 , vital signs measurement: unknown results. Course of the event: The patient waited for the timeframe after the second dose and had no problems. 4 days after, she experienced pain with walking in her left leg. She took Aleve for a few days. It got so swollen, she should have gone then to her Primary Medical Doctor, but she did not go until 25Mar2021. She was sent to Hospital for an Ultrasound of her leg on 04Apr2021. After the Ultrasound, she was taken to the Emergency Department at the hospital. The doctor told her she had numerous blood clots below the knee. Was prescribed Eliquis 5mg. She was instructed to take 2 tablets or 10mg twice a day, 8hrs apart for 1 week and then 1 tablet twice a day for the remainder of the 74 tablets. She completed that. She was out of them and got a refill of Eliquis 5mg on 26Apr2021. She received 60 tablets and can refill for 5 times. She is really concerned. The swelling is still so bad and so that could that mean blood clots are still in there. The ER doctor told her that the medication is dangerous. It thins the blood and can cause bleeding and the blood clot can go to her heart. Follow up information has been requested.; Sender's Comments: The causality has been assessed as related to bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Right Arm on 24Feb2021 (Batch/Lot Number: EN6202) as single dose for covid-19 immunization, based on temporal association and profile of the product.,Linked Report(s) : 2021499984 same patient/drug, diff dose/event

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were pneumonia, A-fib and hyponatremia. Patient died on 4/21/2021

About 45 minutes after 2nd shot I had very odd feeling of lightheaded and dizzy. Also felt like a tight band around chest and difficulty in a deep breath. This lasted about 20 minutes. Since then a lot of joint pain and fatigue

feeling a click right before her fast heartbeat then drink water and slows it down/something clicks in body, heart beats really fast; really bad pain in her right knee; muscles really tight; didn't feel so good; she was scared to death, her nerves; anxiety; very frightened; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right on 21Jan2021 (at the age of 78-year-old) (Batch/Lot Number: EL1283) as 1st dose, single for covid-19 immunisation. Medical history included hypo thyroiditis (does not have it anymore, it was 30 years ago when she was a teacher), knee that was broken twice and allergic to antibiotics from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced feeling a click right before her fast heartbeat then drink water and slows it down/something clicks in body, heart beats really fast, really bad pain in her right knee, muscles really tight, didn't feel so good, she was scared to death, her nerves, anxiety and very frightened. The reporter stated that feeling a click right before her fast heartbeat then drink water and slows it down, was happened after she got her first covid shot. The patient asked to know if it was safe for her to get the second dose of the vaccine. The patient wondered if anyone else, she had the first Pfizer vaccine, later clarified as the COVID vaccine, a week ago last day before the time of this report, and she used to have a really fast heartbeat, but it slowed down, and once in a while, it was fast and stuff, now she had this happened twice, where she felt something click in her body, her heart beats really fast, and she drank water immediately, it slows down, has anyone said this after getting the vaccine. She has been on the phone for two hours. She never had a little click, she had thyroid hypo thyroiditis and every evening she would have a fast heartbeat, her blood pressure would go, but she never had when she would feel this little click, like a little, and her heart was really fast in morning of the report, it was really fast, and the minute she drinks water, it slows it down, it does not make sense. Also, her muscles are really tight, she was 78 and having a hard time with this pandemic, her nerves not good, she was nervous about the vaccine. She stated she was a teacher, and her weight was 106-107 pounds. About the event feeling a click right before her fast heartbeat then drink water and slows it down/something clicks in body, heart beats really fast, the patient stated, unknown when this started, exact date unknown, this has happened twice, this morning was the second one, and the minute she drank water, it slows it down, but it was very very fast, and she did not feel so good after, she was scared to death, her nerves are shot, she has trouble with anxiety, she was feeling ok now. She was nervous about what was going on and would feel better if someone else said they experienced the same. About the event muscles being really tight, the patient stated she has knots, her muscles are tight in her shoulders and neck lots, last night she was writing recipes, she does recipes boxes for her grandkids, and she was using her right arm a lot, she does not get to go to spa since the pandemic, she has not gotten to go to her for over a year. Her husband rubbed it out, and she did heat. Her muscles were tight right after she did it, so it could be something, it said if you think you had a symptom and also the second night after, she had a really bad pain in her right knee, it lasted one night, it was a knee that was broken twice, which may be why it was that leg. She was very very frightened to take it, she reacts to things strangely, when she has any procedure, they always say they never had that happen to anyone, she was allergic to antibiotics, different things happen when she takes different things, she was nervous about the whole thing, which may have to do with it. The second dose is on 12Feb2021. The outcome of the event muscles really tight was recovering and unknown for other events. Follow-up attempts are completed. No further information is expected.

feeling palpitations; blood in her urine; pain in her right kidney; While she was there they took her BP and it was 190/90 and she takes BP pills then last night it was a little high but it came down by itself.; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN5318), via an unspecified route of administration on 25Jan2021 as 1st dose, single for COVID-19 immunization. Medical history included anticoagulant therapy (blood thinner) from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid taken for anticoagulant therapy, start and stop date were not reported. The only medicine that is relevant is the Baby Aspirin, it is 84 mg. She confirms 84 mg baby Aspirin. Her cardiologist gave it to her for a blood thinner. On Jan2021 patient experienced feeling palpitations, blood in her urine, pain in her right kidney and while she was there, they took her BP and it was 190/90 and she takes BP pills then last night it was a little high, but it came down by itself. The patient underwent lab tests and procedures which included blood pressure measurement as 190/90 on Jan2021 she was there they took her BP and it was elevated to 190/90, sars-cov-2 test as unknown results on 28Jan2021 she went to get a COVID test yesterday, urine analysis as blood on Jan2021. Caller is calling about the Pfizer COVID-19 vaccine. She received the first dose 25Jan2021, last Monday and then she began feeling palpitations. She also had blood in her urine and pain in her right kidney. Today her urine was clear but the palpitations are still there and she wanted to call and report and ask does she need to do something about it. Also she went to get a COVID test yesterday. No further information provided. While she was there they took her BP and it was 190/90 and she takes BP pills then last night it was a little high but it came down by itself. No further information provided. She has a flight, should she not fly or is there no problem. She also is set to get the second dose 15Feb2021 and she wants to know what will happen should she not take her baby Aspirin. She takes a Baby Aspiring every 2 days, she took one last night but she does not know if maybe the baby Aspirin is the reason she got the blood in her urine. She wants to know if she should suspend the vaccine or get it. She sees the date she is to get the second vaccine 15Feb2021. She does not see any expiration date. Trying to prevent COVID she is at risk with other issues, she gets pneumonia easy. She has had the vaccine for pneumonia and flu because she is elderly (78) and that is an At risk age. She confirms she wants to know if she should still get the second dose after this experience and also if she does take the second dose should she stop the Baby Aspirin a few days before. The outcome of the events was not recovered for palpitations and recovered for blood in urine, whereas unknown for the other events. Follow-up (29Jan2021): This is a follow-up spontaneous report from a contactable consumer. No new significant information was found. Follow-up attempts are completed. No further information is expected.

Patient has a blood clot; Pain sent patient to the emergency room; Patient was tired, and was having a hard time breathing. Patient was thinking it was something else; Patient was tired, and was having a hard time breathing. Patient was thinking it was something else; This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported for a 79-year-old female patient (reporter's mother) that: Submitted by Call Centre Selected Report Type: Initial Is report related to a study or programme? No Patient Ethnicity: Unknown Is the patient also the reporter? No Reporter type: Consumer or other non-health professional Specify Consumer or other non-health professional: Reporter is patient's daughter Primary / Prescribing Healthcare Professional Info Adverse events: Dates for Patient has a blood clot: (From: Apr2021 To: Ongoing) Reporter seriousness for Patient has a blood clot: Hospitalization Dates when patient was in hospital for Patient has a blood clot: 29Apr2021 to 02May2021 Dates for Pain sent patient to the emergency room: (From: 26Apr2021 To: Ongoing) Reporter seriousness for Pain sent patient to the emergency room: Unspecified Dates for Patient was tired and was having a hard time breathing. Patient was thinking it was something else: (From: Apr2021 To: Ongoing) Reporter seriousness for Patient was tired and was having a hard time breathing. Patient was thinking it was something else: Unspecified Is Pfizer covid vaccine a Pfizer product? Yes Pfizer covid vaccine manufacturer: Unspecified Dates for Pfizer covid vaccine: (Start: 20Feb2021 Stop: Unspecified) NDC number of Pfizer covid vaccine: Unknown Expiry Date of Pfizer covid vaccine: Unknown Why was the patient taking Pfizer covid vaccine (Verbatim): Because of patient's age Other Products: No Patient History: No Investigation Assessment: No Additional Context: Reporter is calling on behalf of someone else. Reporter is calling about the Pfizer covid vaccine. Reporter is hoping for some guidance. It is reporters understanding, that if there is complications after the covid vaccine, there is compensation available. She is asking does she need to go somewhere for that. Reporter is calling about her mother. Reporter's mother is the patient. Reporter's address: Reporter was asked for her mailing address. Reporter stated that she will provide patient's mailing address, that it would be easier to provide patient's address. Primary / Prescribing Healthcare Professional Info: Declined. Patient has a blood clot: Patient is now out of the hospital, but she is on a blood thinner for the next six months. She was diagnosed with a blood clot and hospitalized on 29Apr2021. Patient began having adverse reactions two weeks prior, but patient did not realize they were related to her blood clot. Reporter does not know an exact start date. Patient is getting better with the blood thinner, but the blood clot is still there. Pain sent patient to the emergency room: Pain began on 26Apr2021. Patient is still in pain, but it is not as severe. Patient was tired and was having a hard time breathing. Patient was thinking it was something else: Began about two weeks prior to being diagnosed with a blood clot. The problem is, it is a large blood clots, and has done damage to patient's lungs. Reporter states because of the blood thinners that patient is having to take, patient is having complications. The blood thinners are very expensive. The blood thinners are interfering with other medications that patient is on. No further information provided. First dose administered on 20Feb2021 about 12:00PM in left arm. Lot number: EL9266 NDC: Unknown Expiry date: Unknown Second dose administered on 13Mar2021 at 1:30PM in left arm. Lot number: Unknown NDC: Unknown Expiry date: Unknown Patient Age at Time of Vaccination in Years: 79 Vaccination Facility Type: Other, Pop up clinic. Vaccine Administered at Military Facility? Not provided. Additional Vaccines Administered on Same Date of the Pfizer Suspect: None. Did any AE(s) require a visit to: Emergency Room? Yes. If the patient was hospitalized, how many days was the hospital stay? Four days. Physician Office? Yes. Patient has saw an oncologist, primary care physician, neurologist and pneumologist. Prior Vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: Not provided. Patient's Medical History: None. Family Medical History Relevant to AE(s): None. Relevant Tests: None. Reporter is asking what all she needs to submit to Pfizer Legal. Reporter is asking if she needs a lawyer to handle this. PSCC Communication: Caller notified that all requests for compensation will need to be made in writing to Pfizer Legal. Caller was provided with Pfizer Legal Department's address of Pfizer, Inc. Legal Department Follow-up attempts are needed. Additional information is requested

Flu like symptoms; Weakness; Headache; Tiredness; just sleeping /. She slept it off for a couple of days./felt very sleepy; she could feel her heart racing; had a heavy feeling on her head; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date were unknown), via an unspecified route of administration on 26Jan2021 10:00 (at the age of 78-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included asthma and chronic obstructive pulmonary disease from an unspecified date, diagnosed many years ago. Broken collarbone and Broken wrist on 28Dec2020. It was reported that she had three broken bones in her wrist, she can't lay in bed anyway, so she sleeps on the sofa, getting constipated on an unspecified date, The patient was allergic to Benadryl. It was also reported that she doesn't sleep too well, due to the sitting up in the chair business. concomitant medications were not reported. On 26Jan2021, 2-3 hours after, she felt very sleepy, had a heavy feeling on her head that was almost flu-ish but had no fever nor chills, and she felt that her heart was racing Influenza like illness, weakness, headache, and tiredness. She slept it off for a couple of days. She was enquired if she can still take the 2nd dose of the vaccine given these side effects. It was reported that she had her first dose of the shot on the 26th of Jan and thinks she had a reaction, though it was not enough to go to her doctor or anything, she was too weak. She said she didn't have chills, was not nauseous, had no fever, she feels like she had the flu, and. She said that she gets up and eats then goes back to sleep or does whatever else she had to do. she can't lay in bed anyway so she sleeps on the sofa. she did get up the next day and all the time had a headache. She says she doesn't take the flu shot because her older brother had a terrible reaction to that, none of her siblings take that shot, but she knows what it feels like to have a bad cold with your head heavy, that kind of feeling, she imagines that is what the flu feels like. The patient received treatment with Tylenol for headache. The patient underwent lab tests and procedures which included blood pressure (blood pressure measurement): 110/70 mmHg on an unspecified date, blood test: unknown on an unspecified date, Pulse (heart rate): pulse was ok on an unspecified date. Caller said that she was so surprised when she went to her doctor's appointment that her heart was racing, and she thought her blood pressure would be sky high, but the bottom number was 70 something, which is low for her, and the top number was 110, so it was perfect, which she doesn't usually have. She said that her pulse was ok and everything else was ok, and she had blood work taken that day but they didn't get those results back yet, so she doesn't know what they are. The outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up (13May2021): Follow-up attempts completed. No further information expected.

Patient has one episode of Palpitation for about an hour, got better on its own. Patient had palpitation, long time ago and got better with ablation.

because of blood pressure and AFIB issues and had a pacemaker implanted and missed her 2nd shot.; because of blood pressure and AFIB issues and had a pacemaker implanted and missed her 2nd shot.; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 78-years-old female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 06Apr2021 (age at vaccination 78 years) as single dose for COVID-19 immunization. Medical history included previously had a stroke 3 months ago. Been in Anaphylactic shock in the past due to severe allergic reactions to medication. Concomitant medications included was not reported. she was on Eliquis which a blood thinner and taking other heart medication. On 27Apr2021 the patient was admitted to the hospital, she had previously a stroke 3 month ago and she was admitted to the hospital for implant of a pacemaker on Apr27. she was recently released from the hospital and patient was in the rehab for about 2 weeks. she wants to know it safe for her to get the second shot under these circumstances. Patient on Eliquis used as a blood thinner and taking other heart medications. She going to be 79 next months and patient just wanted to know if there's a risk for patient. and she also had been in anaphylactic shock in the past due to severe allergic reactions to medication. she wants to confirm that the weather needs to reschedule for 1 dose if patient missed the 42 days window. Consumer was provided Pfizer Medical Information website. On 27Apr2021 the patient experienced because of blood pressure and AFIB issues and had a pacemaker implanted and missed her 2nd shot. The outcome of events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Shaky; Warm; My face turned red; My hands were shaking; I felt my heart skipping with irregular heart beats; The nurse measured my blood pressure and it was 183/95 with a pulse of 104; This is a Spontaneous report from a Contactable Consumer (patient, self-reported). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Feb2021 at 08:30 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included hypertension, chronic lymphocytic leukemia, osteoporosis, glaucoma and known allergies: reaction to epinephrine (cannot have Novocain with epinephrine), reaction to histamines and tyramine. Concomitant medications included metoprolol succinate (TOPROL XL), Amlodipine, Levothyroxine, and Atorvastatin. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 03Feb2021, about 7-10 minutes after receiving the shot, she started to feel extremely shaky and warm. Her face turned red, and her hands were shaking. She felt her heart skipping with irregular heartbeats. The nurse measured her blood pressure, and it was 183/95 with a pulse of 104. She was observed for an hour. The patient did not receive treatment for the events. Outcome of the events was recovered on an unknown date in Feb2021. Follow-up attempts completed. No further information expected.

syncope; Acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; hemorrhagic contusion with edema; hemorrhagic contusion with edema; fatigue; malaise; HA; This is a spontaneous report from a contactable physician. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 21Feb2021 (Lot Number: EN6200) (at the age of 78-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension (HTN), hyperlipidemia (HDL) and hypothyroidism, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The patient previously took SSRI, PNC (unknown), sulfa and oxycodone; the patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 31Jan2021 (Batch/Lot Number: EL9265) as single dose for COVID-19 immunisation. Within 12 hours of vaccine (on 22Feb2021) the patient developed symptoms of fatigue, malaise, headache (HA) and severe and near syncope. She visited the emergency department (ED) the following day. Work up at that time including blood work and no imaging. She was treated with IVFs and discharged. Symptoms of malaise, fatigue and HA persisted for > 1 week. A computerized tomogram (CT) of the head was performed on 05Mar2021, this CT showed the following: acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; 2X3 left front hemorrhagic contusion with edema. The events required emergency room visit and physician office visit. Therapeutic measures were taken as a result of the events and includes conservative measures (as reported). The patient outcome of the event was recovered with sequel.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Feeling unwell; fast heart beat; nauseous; unbalanced when walking; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN9810 and Expiration date not reported) via an unspecified route of administration, administered in Arm Left on 04Feb2021 14:35 as 1st dose single dose for COVID-19 immunisation. The patient medical history included anxiety from Unspecified to Unspecified date. The patient concomitant medication included alprazolam (XANAX) taken for anxiety from Unspecified to Unspecified date. The patient received no other vaccines in the past 4 weeks period. On 05Feb2021, morning, she noticed she is feeling unwell and had a fast heart beat. After eating it got a little better. It says on the paperwork normal side effects to expect like feeling unwell and fast heartbeat which has calm down for her, but she was wondering how long this was expected to last and have the side effect. She was not feeling good this morning. She doesn't want this to last a long time. The patient reported that after the vaccine she felt nothing, no pain, no pain even at the arm. The patient reported that, she was not completely sure how she was feeling because she was sitting now, she felt nauseous and unbalanced, she was feeling unwell. As she was sitting down, she thinks it was better, but she still feels unbalanced when walking. The patient took half a Xanax when her heartbeat was fast, that was usually the trick that slows it. It was reported that, she takes Xanax for anxiety and maybe that was it was. She took the Xanax because she had to wait on the phone for so long to speak to someone. The second dose was schedule date on 02Mar2021. The patient had so many medications, but had not taken them before this started, she took them later. The patient received list of what she could expect, on the list what she had was a common reaction, but the Fast heart rate was in the call section, but it was not that bad for her to call 911 as she knows a fast heartbeat can happen with her anxiety. She usually gets the flu vaccine and pneumonia vaccine, she does not remember when she had it last, she usually gets them when it comes out or when pharmacy announces it and asks her. The patient noticed that people who usually get the COVID virus die of Pneumonia, so she thought she would get the pneumonia vaccine. The patient had some exam 2 weeks ago, and yesterday the Physician left a message about the results and did state on the phone that she has nothing to worry about. The outcome of Feeling unwell was not resolved and fast heart beat was resolving. Follow-up attempts are completed. No further information is expected.

Blood pressure high; her doctor could see that she had some pneumonia showing; Coughing; soreness in her arm; slept all day long; started running a 99.9 temperature; could not catch her breath, her breathing was down in the danger zone at 220; This is a spontaneous report from a contactable consumer (Patient). A 79-year-old elderly female patient received bnt162b2 (COMIRANTY; Solution for injection; Lot number and expiration date was not reported), via an unspecified route of administration on 11Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date the patient experienced, the patient could not catch her breath, her breathing was down in the danger zone at 220 reported dyspnoea and hospitalization on an unspecified date, had high blood pressure, her doctor could see that she had some pneumonia showing, coughing, soreness in her arm, slept all day long. Additional Context: Consumer states that her doctor wanted her to call and report this, because she has asthma and allergies that are chronic. Consumer states that she took her first Pfizer injection in April. She saw her allergy specialist on the 1st, and she tested the Consumer before she took the vaccine. She states that her breathing was at 113% breathing capacity (good) and the allergy specialist wanted her to go ahead and get the injection, which the Consumer did. Consumer clarifies that she received the first Pfizer COVID vaccine on 11Apr2021 and that she did really good with that one. Consumer then received the second COVID vaccine on 13May2021. She came home and slept almost all night long and thought she was okay. The Consumer explains she was not feeling real good before she went to receive her second dose. It was kind of like she was having some coughing and stuff, but she thought it was not bad and that she could still go ahead and get it. She went ahead on 13May2021 and had the second dose. Consumer states that on the first day, she slept all day long- the whole entire day, she didn't even wake up. On the second day, the Consumer states that she had soreness in her arm. Then, she noticed she was getting really sick and started running a 99.9 temperature. It was getting worse day by day, and she kept coughing and getting worse. Then, on 18May2021, her husband took her to the emergency room and they just automatically treated her for asthma and allergy and sent her home. This was on Tuesday night. On Thursday night, she got so bad that her breathing was down in the danger zone at 220. She couldn't breathe. Her husband rushed her back to the ER and this time, they kept the Consumer and hospitalized her for a week. Her blood pressure was high. She clarifies normally her breathing on her peak flow meter, she can always do from 350-400. Well on Thursday night, her peak flow was all the way down to 220 and she could not catch her breath. Consumer states that she was admitted to the hospital and they had her on oxygen and blood pressure medication. She states that they did a bronch on her and still did not really come to a conclusion of what was happening. She was told it looked like it could be an infection in her lungs. Consumer states that she is having to see three doctors this week because of this since she got out of the hospital. She saw her medical doctor, Dr., yesterday who was very concerned because she had a recent patient that was about the same age as the Consumer- he was 75 years old. This patient had done the same thing, only he ended up taking pneumonia and dying with it. The doctor told the Consumer in her x-ray, her doctor could see that she had some pneumonia showing. The Consumer asked her doctor while she was in the hospital about the pneumonia and they refused to listen to anything the Consumer said, so Dr. told her that the Consumer needed to report this because she is still so sick. Consumer clarifies that she was hospitalized for a week and that she just got out on Saturday, 29May2021. While reporting the event details, the Consumer stated that she had and emergency call coming through and that she had to take it. Consumer had to end the call, stating she had to go and requested this call handler call her back. The patient was hospitalized due to events. The patient underwent lab tests and procedures which included blood pressure measurement, body temperature: 99.9, peak expiratory flow rate: 220 Units: x-ray: had pneumonia showing. The outcome of the events was unknown.

Patient stated she had the Pfizer #2 vaccination end of April (unsure of date) and 1 week later became symptomatic with SOB. For 3 weeks she felt SOB with CP. She presented to hospital and found to have bilateral pulmonary embolisms. Please contact patient for further details. She states she is very healthy and does not have risk factors for clots. She requested I fill out this form for her. I spoke to our pharmacy and they directed me here. I do not know all of the details therefore more investigation should be performed.

Within 2 weeks of shot, AFIB episodes increased in number, going from one ocassionally, to 2 within 2 weeks and then on April 2, 2021, they began to occur daily and last for 6-8 hours. This continued for approximately 5 weeks after which they began to subside and now happen weekly at much shorter intervals

Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; BP was high; high heart rate & MAP; high heart rate & MAP; tired; left side of throat felt swollen; feelings of being "out of sorts"; Small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins; Mild nausea; Arm soreness at vaccination site; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in left arm on 14Mar2021 13:15 (at the age of 78 years old) as 2nd dose, 0.3 mL single for covid-19 immunization. Medical history included thyroid nodules, mild macular degeneration, postmenopausal syndrome, high blood pressure (HBP), total hysterectomy w/oophorectomy, gallbladder removal, appendectomy, allergy to penicillin, allergy to contrast dye, allergy to adhesives, and hard of hearing (HOH). Concomitant medications included valsartan (DIOVAN); famotidine (FAMO); pravastatin; estrogens conjugated (PREMARIN); levothyroxine sodium (SYNTHROID); and vitamin D3, all taken for an unspecified indication, start and stop date were not reported. The patient previously took nitrofurantoin (MACRODANTIN), clarithromycin (CLARITIN) and experienced drug drug allergy from both; also previously received the first dose of BNT162B2 (Lot number: EN6201), on 14Feb2021, 13:00, administered in left arm, for COVID-19 immunization. On 14Mar2021 late same day, the patient experienced mild nausea which lasted less than an hour, arm soreness vaccination site. On evening of 15Mar2021, a small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins. Upon waking on 16Mar2021 the patient was still itching spots plus left eye was itchy, dry and red; with a bit of nausea, BP was high, no fever, high heart rate and mean arterial pressure (MAP), was tired, left side of throat felt swollen, feelings of being "out of sorts", and her arm no longer hurts at all. The patient took Benadryl and Aleve and all seem better at the moment. She stated she would describe her symptoms as mild although somewhat scary especially the increase in blood pressure and MAP. Her oxygen was normal at 95-97. The patient was recovering from the events.

I went to have a minor surgery on my hand and they took my blood pressure and my pressure was elevated. I contacted my doctor because my pressure stayed high. I increased my blood pressure meds and it was able to stabilize.

Five weeks after the second dose of the vaccine I noticed my heart was fluttering. I was having palpitations. I visited my doctor and the EKG did not show any problems. I then wore a heart monitor for 48 Monitor and it showed that I was having PVCs. I have never had any heart rhythm problems before. I am a Marathon Athlete and in good health normally. I still have the PVCs which seem to be OK when I am running but get worse with stress.

day after getting the 1st dose she got a headache/chills/low temp/couldn't more left arm/arm, neck and shoulder pain

This is a spontaneous report received from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9809) via intramuscular route of administration in left arm on 05Feb2021 at 09:45 (age at vaccination 78 years old) as single dose for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing Mother had heart issues, but she is passed away, ongoing panic attack the caller said that she has only had like 2 panic attacks in her life. She said that on 30Dec2021 she had a panic attack on the day of the vaccine, she had a light one on the way to get the injection, she said that she had COVID-19 previously and was diagnosed 05Jan2021 and was cleared so she took the vaccine, ongoing fatigue She said that her tiredness started during when she had COVID-19, but stated that she understands it was a symptom post COVID-19, ongoing gait disturbance She said that she may have been wobbly on her feet since she had COVID-19, but has gotten worse since the injection. There were no concomitant medications. On 05Feb2021 the patient experienced panic attack, her heart was racing/heart was racing to 132, unstable and wobbly on her feet, extremely tired and on unspecified date in February 2021 she said she feels like her eyesight has gotten worse, unstable and wobbly on her feet was reported as worsened/extremely tired was reported as worsened/she said she feels like her eyesight has gotten worse/and got very worse after vaccination. with outcome of unknown. The patient underwent lab tests and procedures which included electrocardiogram fine in 2021. The clinical outcome of the event panic attack, her heart was racing/heart was racing to 132 were recovered and unstable and wobbly on her feet, extremely tired were not recovered other events were unknown. Follow-up attempts are completed. No further information is expected.

I experienced shortness of breath and inability to draw a deep breath. I thought I was experiencing allergies. I went to see my primary care physician's assistant. She became alarmed when my heart rate was 141 and insisted I go to the hospital via ambulance right then (May 11, 2021 approximated 10:30 a.m.) I spent the first day in the Emergency Room at Hospital then was admitted to a private room. I was discharged on May 14th with prescriptions for Eliquis, digoxin, lasix, metoprolol, and lisinipril with the hope that m heart would return to normal pulse on its own, I had a echocardiogram, confirming Atrial Flutter. had an angiogram and was told there were no blockages. I had a transesophageal echocardiogram. It determined the doctor could not safely shock my heart back into rhythm. I have another scheduled for July 1, 2021.

Death 5/25/2021 Causes of death listed on death certififcate: 1. Acute Hypoxic Respiratory Failure due to Bilateral COVID-19 pneumonia 2. Bilateral Covid-19 Pneumonia 3. Covid-19 disease 4. Acute Renal failure, Metabolic Acidosis, Hyperkalemia, Acute Congestive cardiac failure

One day after first dose of Pfizer vaccine, patient was admitted for fever, weakness and altered mental status. At admission exhibited SIRS (fever, tachycardia), ultimately no infection was identified on work up.

dizzy; cramping in stomach; hard to swallow solid food; body shook; chills/teeth chattered; BP rose to 170/89; felt jittery; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported that a 78-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing high BP Onset date: 5+ years Stop date: Ongoing Pertinent details: Controlled; ongoing acid reflux disease Onset date: 10+ years Stop date: Ongoing Pertinent details: Controlled. There were no concomitant medications. On 20Feb2021, the patient experienced BP rose to 170/89; felt jittery; chills/teeth chattered; body shook; On 21Feb2021, dizzy; cramping in stomach; hard to swallow solid food. The patient underwent lab tests and procedures which included blood pressure measurement: 217/105 mmhg on 28Jan2021, blood pressure measurement: 170/89 mmhg on 20Feb2021, pyrexia: 103 on 28Jan2021. It was reported that patient took 2nd shot on Wednesday 17Feb. On Saturday 20Feb BP rose to 170/89 felt jittery. On Sunday 21Feb become jittery, dizzy, BP high and had cramping in stomach. Hard to swallow solid food. Went on until doctor ordered Dicyclomine. It helps. On Saturday 20Feb had chills for 2and half hours. Teeth chattered and body shook. Stomach was still cramping after 2and half weeks and solid food is hard to swallow. I have an appointment with a gastrologist. The clinical outcome of all events were unknown. No follow-up attempts are possible. No further information is expected.

chest pain that went around to my upper back also; chest pain that went around to my upper back also; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269, expiration date: not reported), via an unspecified route of administration, administered in arm right on 06Feb2021 09:00 (at the age of 78-years-old) as dose 2, single for covid-19 immunisation. Medical history included heart attack in 2019 and 5 stents put in, known allergies (unspecified), known allergies: yes. Historical vaccine patient received included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL2283, expiration date: not reported), via an unspecified route of administration, administered in arm right on 13Jan2021 08:00 (at the age of 78-years-old) as dose 1, single for covid-19 immunisation. Concomitant medications were not reported. other medications in two weeks. No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination. On 08Feb2021 08:00, the patient experienced 'chest pain that went around to my upper back also'. The patient underwent lab tests and procedures which included bloodwork, chest x-ray, electrocardiogram (EKG) and ultrasound scan, all with unknown results in 2021. Chest pain that went around to my upper back also lead to emergency room/department or urgent care. Unspecified treatment was given for chest pain that went around to her upper back also. The outcome for both events was resolved in 2021. No follow-up attempts are possible. No further information is expected.

went right back to sleep after her call and didn't wake up till next morning,; dull headache; head was swimming; blood pressure went to 220/blood pressure was really high; black spots across my face; swimmy headed; legs didn't feel like they would hold her up/felt like my legs weren't going to hold me up; weak; very fatigued; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8731), via an unspecified route of administration, administered in left arm on 15Apr2021 13:15 (at the age of 78-years-old) as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She had her shot and just had a bad reaction to her very first shot. She came home, states sometimes she may doze off for 15 minutes or so but she fell asleep until at 16:00 she was woken up by a call from a friend. On 15Apr2021, she felt very fatigued and weak on Friday; later adds she was tired the day of shot as well. She laid around all day sleeping on Friday. On 17Apr2021 Saturday her legs didn't feel like they would hold her up and so she laid around again all day. On 18Apr2021 Sunday she knows had gotten up to go to bathroom a couple of times in the night; but then in the morning she was going to get up and felt faint; later adds she felt dizzy; states her head was swimming and she saw black spots and it scared her to death. Adds she thought she should go and sit up in the living room. But even after she sat down, sitting straight up, she kept seeing black spots. A friend took her to the emergency room (ER) for the dizziness and seeing spots. At the ER they found her blood pressure was really high; she thinks it was 220 over something, she forgot the bottom figure. They put an IV in to give her medication; did an electrocardiogram; a chest xray; blood work; a urinalysis and all of those tests everything was fine. The ER staff helped her to bathroom and her head was still swimming but they said that was because her blood pressure was still high. Adds her blood pressure went down on it's own and she had no medication for the blood pressure. They told her you are remarkable at your age to not to be on medication. She saw her doctor yesterday. Reports at the doctor's office her blood pressure was about 128/63. The doctor told her it was kind a low and that she basically runs low. She was not dizzy anymore on Sunday after her blood pressure went down. Adds she got a dull headache yesterday but she thinks it might of been a caffeine headache because she has had a caffeine headache in the past when she had to stop caffeine for a test or something. She has to take the second dose on 06May2021, and her doctor told her to take it; but she is scared to death. She asking for a recommendation as to whether she should get the second dose. The adverse event resulted the patient to visit emergency room and was not admitted and also visited to physician office. Outcome of the event hypertension was resolved on 18Apr2021, while for events- black spots across my face, dull headache, swimmy headed, feeling abnormal, head was swimming was resolved on 19Apr2021 and that for fatigue, weak was not recovered and sleep disorder was unknown. No follow-up attempts are possible. No further information was expected.

TIA, right side of body weakened to point of not being able to stand, left side of face numb, emergency hospital 24 hours for monitoring and tests.

Two days after COVID vaccine, patient suddenly lost a tooth, despite having no prior dental issues. Then her face ended up developing a long last swelling and rash episode that lasted for 1.5-2 months. Patient thinks it was a reaction to the amoxicillin she was given, but it persisted despite not being on the medicine, being given steroids, and antihistamines. Patient was in the ED twice for the facial swelling. Also saw Dermatology. Pt later saw an allergist and she is not allergic to amoxicillin, only other new thing had been the vaccine when it all started. Then the patient suddenly develops severe bradycardia to the point of syncope and episodes of sinus arrest. Patient then ended up requiring a pacemaker to be placed.

hospitalized with SIRS the next day, 2/20/2021, thought to be due to the immunization. discharged 3/4/2021

Prior to March 21, 2021 patient was able to walk on her own (although pace was slow), get in and out of bed or chairs, able to dress herself, use the toilet and shower and communicate verbally (although voice was not very loud. She received the second Pfizer/BioNTech COVID-19 vaccine 2:30 PM on March 18, 2021; on March 21, 2021 she had gotten up at 4:00 AM and was walking through the kitchen when she found herself on her back on the floor and was unable to get up. She required help in getting up and has not been able to walk on her own ever since. She requires help in getting in and out of bed, in and out of chairs, cannot use toilet and shower on her own, is unable to dress herself and her voice has become a whis

Nine days after the first dose of the vaccine on 02/01/2021 during the night I had a severe headache and I lost consciousness. I was taken to the hospital and I had had a stroke. I was hospitalized for four days and transferred to rehab on 02/05/2021 where I remained for 21 days. I was discharged from rehab on 02/26/2021. I also had in home therapy and continued to receive physical therapy until recently. I received the second dose of the vaccine in the hospital on 02/11/2021.

pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, chest and back; pains radiating down right arm, chest and back; nausea; Vomiting; severe chest and back pains on right; severe chest and back pains on right; This is a spontaneous report from a contactable Other Health Professional (patient). A 79-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient medical history was not reported. Concomitant medication in two weeks included citalopram, levothyroxine, atorvastatin, anastrozol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 3rd day (21Dec2020), the patient experienced severe chest and back pains on right at time of 12:30 AM. On 4th day (22Dec2020) pains radiating down right arm, chest and back, nausea and vomiting. On 5th day (23Dec2020) pain under right arm pit, very stiff neck, pain radiating into ear. Temperature was normal. On 6th day (24Dec2020) most symptoms dissipated. On 7th day (25Dec2020) almost back to normal. No treatment received for the events. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.

Dizziness, Diarrhea, Palpitations & Tachycardia Narrative: Patient remained in facility for 15 minutes after receiving vaccination. Upon ambulating to depart facility, patient returned to area complaining of dizziness and fast heart beat. Patient was immediately seated and vital signs were obtained. 0954- BP 150/82, pulse 80, Oxygen saturation 95%, and temp 97.8. Patient drank 8 ounces water. Patient reported feeling better after 10 minutes. Repeat vital signs at 1007 BP 127/74, pulse 80, oxygen saturation 95%. Patient with no further complaints of dizziness or fast heart beat. Patient did not verbalize any other complaints. Patient denied escalation to emergency department. Condition was resolved prior to leaving facility. Patient left facility ambulatory without any difficultly, and was accompanied by family member. Patient instructed to call 911 and report to nearest emergency room for any further issues or complaints. Patient verbalized understanding of instructions in her own words.

Resident had seizure like activity followed by a vagel response with large bowel movement. Resident then began to show signs of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low oxygen levels. Resident not responding to stimuli.

Pt ambulated w/ assistance into observation area, upon sitting down in observation, Pt appeared faint, almost losing consciousness, Pt never lost consciousness, Dr. called, Dr. and more staff arrived, Pt was assisted to the floor, O2 began @ 8L, then lowered to 4 L, vitals taken BP 145/80, HR 76, O2 98%, O2 sat flucuated btw 84%-98%, AXOX4, EMS arrived within minutes and took over, Pt observed by EMS for 30mins. stable and released to go home per Pt request.

Pt reports symptom onset 2:04 of palpitations and throat "slightly tight". States she has a pacemaker and "just wanted to make sure everything is OK" Observed drinking ice water without difficulty. VS 163/81, pults 64, respirations 16. Observed x 20 minutes, VS remained stable. Pt states "sensation" has resolved. Advised to call 911 if symptoms worsen. Released to husband's care.

Within 5 minutes of receiving the vaccine, my heart started racing, my blood pressure shot up to 190 over ? (Usually my BP is low normal), my face was very flushed.

right arm unusable for 48 hours following injection, high blood pressure (200)4th day, TMJ 4th and 5th days, joint pain in both shoulders 3rd day

Fleeting headache after vaccination. Chest tightness last night which is a little more than usual. Feels fine today.

patient presented to her primary care for evaluation of leg pain. Noted on US that patient had a DVT in Left distal superficial femoral and popliteal veins. patient was hospitalized for treatment as patient had recent diagnosis of GI bleed and would need close monitoring of blood thinning medications. Of note- patient is 1/3 hospitalized with cardiac/blood issues currently in this facility who received a vaccine from this pharmacy in the last month and all three patients have the same COVID vaccine lot number. Physician elected to have a VAERS put in on all patients to ensure investigation was properly handled.

Irregular heart rate pretty severe for a couple of hours then I had chills and enough to make my teeth clatter and also dry heave for some hours until I took the medicine under the tongue and it got better. I still have shaking in my hands and feet as well.

Numbness and tingling sensation on right side of the body (leg, arm, back) Flushing in the face Higher than normal blood pressure Sensations started earlier in the day on Saturday. On Sunday at 1pm, she went to the hospital and the symptoms stayed until 6pm. She was sent home from the hospital with diagnoses of parasthesia and numbness. Sensations started again earlier today, Wednesday the 27th. Called the doctor and said there isn't much they can do because they don't know much about the vaccine.

Shortly after vaccination, patient developed dizziness and tingling sensation along jawline. Patient mildly hypertensive. Approximately 15 minutes later, dizziness developed but tingling sensation also experienced in bilateral feet. Evaluated in ER and ultimately sent home without further complication.

Started on 1/25/2021. Patient developed palpable purpura and petichia to bilateral lower legs. Platelet count transient drop to 126k, then back up to 150k.

1300 - After vaccine administration pt c/o dizziness/lightheadedness. Skin was pale & diaphoretic. Assisted to supine position on floor. Feet elevated. BP 190/80, Pulse 96, RR 28 Axox3. 1305 pt remained on floor confusion noted, Axox1, repetative questions BP 189/80, states "Why am I here?" 1310 Pt. remained in supine position, continues to ask repetitive questions even after re-orienting to person/place/time. Husband states "I think she's just nervous." 1320 Pt. continues to show signs of confusion, states "What happened, who are you? Why did I get a covid vaccine? who gave it tome?" 1320 911 called 1345 Pt. transported to Hospital via Medic

Seated playing cards. Sudden onset extreme dizziness, short seizure, blacked out X 1-2 seconds Other player called 911. One fire truck followed shortly by one ambulance both with two very cute EMTs. All vital signs normal. Very similar to dehydration attacks but worse and that always followed rising and walking. This attack worse and was not set off ambulating. Worried about a worse effect after second vaccine.

Dizzy and light headed, mild nausea, weak and tired with occasional shortness of breath. Elevated blood pressure causing headaches. I have been unable to send this via the phone/text. I am exhausted from this continued distress. Normally very active and healthy.

Cardiac arrest; Patient transported by EMS to hospital 11:00pm on 01/29/2021. Patient received vaccine on 01/25/2021. Patient expired 01/30/2021 within the hour into the new day after midnight on 01/30/2021. Patient was feeling well prior to and any chronic health conditions were well controlled. Sudden cardiac arrest 4 days after receiving the vaccine. Details given by patients husband/POA.

Pt received COVID 19 vaccine at 1400. While in 30 minute observations area patient had c/o chest pressure, SOB, lightheadedness, Patient appears in NAD, skin PWD, patient is restless. Patient requesting b/p to be checked. Patient taken to first area where EMS on duty assessed patient. B/P 190/8-0 HR 90, RR 18, SaO2 96% on RA, CBG 144. Patient sitting in wheelchair and did state that she had a history of HTN and did not take prescribed medications, Lisinopril, Norvasc, today. Pt also take venlafaxine for anxiety. Pt observed by EMS, given snack, and water. Patient reports improvement of symptoms. VSS: b/p 156/70, HR 88, RR 18. Patient cleared by EMS and discharged home at approximately 1445.

Chest palpitations, thickness of tongue. Medic administered epinephrine injection and benadryl though IV in arm in tent on site. Taken by ambulance to hospital and observed for over 4 hours.

Patient complained of feeling feverish. Vital signs taken and patient temp was initially 99.4 then went down to 98.5 after 30 minutes. BP was elevated and ranged from 181/113 - 175/109. BP remained high, therefore, patient taken to ED for medical clearance.

79 yo female with past medical history only significant for endovascular coiling of cerebral aneurysms over 30 years ago presenting with fevers, fatigue, weakness, noise sensitivity, myalgias,and tremors. She exercises regularly and has become so weak that she cannot climb stairs. Neurological exam revealed hyperreflexia, subtle proximal muscle weakness, the presence of a startle reflex and rooting reflex, clonus, and a positive Babinski. Infectious work up has been negative, autoimmune evaluation is underway. Inpatient neurology consultation has been obtained, she was given a trial of diazepam for stiff person syndrome and started on daily IVIG on 2/3/2021 for a 5 day course. She continues to have an elevated CRP, a mild transaminitis, and mild thrombocytopenia. The ESR dropped from 44 to 20 with hydration. She has had no cognitive changes. No headache, visual changes, jaw pain. We are unable to obtain MRI given the presence of these coils which are not MRI compatible. Encephalitis immune antibodies are pending, myositis panel, MOG antibodies ADEM are pending, GAD65 antibody pending.

hypertension/Blood pressure high; Really tired; some stuff with her kidneys; This is a spontaneous report a Pfizer Sponsored Program from a contactable consumer (patient). A 79-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EL8982) on 16Jan2021 14:30 at single dose in right arm for to prevent Covid-19. Medical history included ongoing sjogren's syndrome, hypertension. Prior vaccinations, the patient maybe tired and unwell from the flu vaccine and shingles vaccine (SHINGRIX) for immunization. There were no concomitant medications. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient got her first vaccine on 16Jan2021. About 3 days later, on 19Jan2021, she was really tired but it only lasted for that one day. States that on 19Jan2021, 20Jan2021, and 21Jan2021, her blood pressure shot way up and she went to the ER on 21Jan2021 because it had been so high for a few days. States that at home it was 172/104, 172/107, and 200/103. When she got to the ER it was 200/110. States that her blood pressure has improved on it's own today. While she was in the ER, they checked her Troponin's which were low, her EKG was normal, and the doctor said everything looked okay, except some stuff with her kidneys but that doesn't have anything to do with her blood pressure. Before she got the first dose she had a history of hypertension but it was already managed by medication and her BP was on normal range prior to vaccination. The AEs High blood pressure and Really tired require a visit to Emergency room on 21Jan2021. The patient was on BP medications. The patient was hospitalized for hypertension and Really tired. The outcome of hypertension was recovering, of Really tired was recovered on 19Jan2021, of other events were unknown. Second dose was scheduled on 06Feb2021.

Within 15-minutes of vaccination, the patient reported dizziness and feeling lightheaded. EMS managed patient's care on-site. Patient was hypertensive (178/96), SPO2 96%, and HR 90bpm. EKG was unremarkable. FSBG was 137 mg/dl. During EMS evaluation, patient stated they were feeling better and refused transport to hospital.

At 1207, resident was noted having facial twitching and seizures and crackles , Vitals: BP 199/95, O2 Sats 89% on RA, PR 88, Temp 97.3, RR was hardly counted because of body movement. Blood sugar was 172 mg/dL. Hooked on O2 at 4L per NC. Informed MD and ordered to send to ER. Family - were updated. Ambulance was called. Family clarified resident's status is DNR. Report was given to ER nurse. Updated ER that INR today is 5.5 and MD ordered to HOLD Coumadin till 02-11-21.

45 minutes after injection the left side of my face became numb to half of my tongue BP was higher than normal 177/97! Numbness lasted about 45 minutes! BP was back to normal the next morning! 2/9/2021

Vaccinated at 12:45. No reaction until 7:45 pm. Racing heart, labored breathing, pressure and slight pain in chest. Called 911 and to Hospital ER. Aspirin given in ambulance. All back to normal by 10 pm and went home.

She started having breathing problems/heart attack appearance. on 1/22/21 and went to the ER. Upon admittance was told it was an anaphylactic shock from the Covid shot. They kept her in ICU and released her 1/23/21. At 12:45 am on 1/24/21 she passed out and we called the ambulance. Hospital admitted her and worked through multiple organ failure issues and thought her numbers were under control. She was released on 1/27/21 and was driving on 1/28/21 around 4:15 pm and appears to have had heart failure and had a wreck. She passed away that day.

91.2kg 79 yo nonsmoking/nonEtOH drinking M with PMH significant for Parkinson's disease, postural hypotension, recent hip surgery and eye problems was at the vaccine clinic for his 2nd Covid-19 vaccine with the product. Allergy history includes tree nut and MSG allergy (hives, swelling, pruritus) and Sinemet, midazolam and fentanyl causing nausea or vomiting. After IM injection of the vaccine (lot # EM9810) into his left arm, the patient felt lightheaded. Patient was diaphoretic and pale. BP was 64/49 with HR 66 and O2 sats 92% on room air which is near baseline. Patient was moved to a recliner chair with feet elevated and given something to drink and monitored

Drooping of left cheek; Elevated blood pressure; nodes in neck enlarged; sore to touch; headache; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261, expiration date was not reported), via an unspecified route of administration on 28Jan2021 09:45 at single dose for COVID-19 immunization. Medical history included allergies and known allergies to sulfa drugs. Patient was not pregnant at the time of vaccination. Concomitant medication included ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION), iron, colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN). The patient previously took first dose of bnt162b2 on 07Jan2021 09:45 on the left arm for COVID-19 immunization. The patient experienced elevated blood pressure, all nodes in neck enlarged and sore to touch, drooping of left cheek and headache on 29Jan2021 22:00. Condition persisted for 4 days. The patient received an unspecified treatment. The patient had a visit to the doctor and emergency room. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events at the time of the report.

may have had a mini stroke; Bell's Palsy/developed facial drooping/her eye was drooping; fell; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (BNT162B2, Pfizer COVID-19 Vaccine; Batch/lot number: EL9262), via an unspecified route of administration injection to right upper arm on 22Jan2021 14:00 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing she was a fainter (She was a fainter, she just faints so she has a hard time getting shots. Pfizer COVID-19 Vaccine administered to her by nurse while she was in her car seat. She just asked the nurse to let her lay down in the car seat when injection was administered so that if she fainted she would not fall far; she was still getting the wash cloth on her head preparing when the Nurse had already finished administering the injection.); ongoing depressed sometimes (she was depressed sometimes, was stressed. She was the primary caregiver for her 96 year old mother. She had seen something about stress and COVID and shots and everything); ongoing Very tired (She was almost 80 years old so she was very tired often. She was the primary caregiver for her 96 year old mother. By the time she comes home at night around 21:30 she was just wiped.); Obesity (She was really overweight but she did not like the term obesity.); thyroid disorder; hypertension; Cataract and glaucoma in left eye; family history of ongoing facial paralysis (Dad had Bell's palsy that might have been 30 years ago. He died at age 87 years.); diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes). Concomitant medication included Levothyroxine at 100mcg taken once daily in the morning early before she eats with Start date unknown, but at least 10-15 years ago for Thyroid. Enalapril at 10mg taken once daily (Caller initially reported product name as Vasotec, but clarified it is not Vasotec, it is drop for eye cataract and glaucoma) for High blood pressure. Brimonidine with Strength unknown, 1 drop in both eyes twice daily, started maybe 1 year ago. Specified cataract and glaucoma in left eye; but drop was administered to both eyes; and left eye was eye affected by Bell's palsy for Cataract and glaucoma in left eye. The patient previously took codeine and experienced allergy with onset maybe about 50 years ago, she was not sure; occurred during dental procedure; had bad headaches but no lasting effects so they assumed allergy to codeine; she did not know if still has allergy but says she does if asked. The patient experienced bell's palsy/developed facial drooping/her eye was drooping on 29Jan2021 with outcome of recovering, may have had a mini stroke on an unspecified date with outcome of unknown , fell on 27Jan2021 with outcome of unknown (reported date of end of reaction was 27Jan2021), she could not blink that eye on 29Jan2021 with outcome of not recovered. Five days later she fell and developed facial drooping. HCP suggested she may have had a mini stroke causing facial drooping and the fall. She went to the ER on 29Jan2021 and the ER believed it was Bell's Palsy. She was still experiencing facial symptoms but they are improving. This consumer was administered her first dose if Pfizer COVID-19 Vaccine 22Jan2021. She reported having fell 27Jan2021. She was diagnosed with Bell's palsy in 29Jan2021 after having been seen in the emergency room. She is supposed to have the second dose/booster of Pfizer COVID-19 Vaccine on 12Feb2021. She called to ask if she should or should not still get the second dose as scheduled; and if Bell's palsy could be a reaction to the Pfizer COVID-19 Vaccine. The emergency room staff did not know how she got Bell's palsy, but knew she had the Pfizer COIVD-19 Vaccine and were kind of assuming the Bell's palsy was a reaction to the vaccine. She dis not have Bell's palsy bad. The emergency room staff thought at first she had a stroke before diagnosing her with Bell's palsy. On Wednesday, 27Jan2021 she had a friend named (Name withheld) who came over for tea. Patient has an oriental rug, and around 15:00 patient fell face first on oriental rug. She was just fine after the fall initially. She wonders if her having fell has anything to do with the Bell's palsy. She thinks it was the night of 27Jan2021 or 28Jan2021 when she asked her son if her face looked funny, did she look ok, because her face felt a little funny. She was looking in the mirror and her smile was looking crooked, and her eye looked like it was drooping. When she got up Friday, 29Jan2021 she could see her eye was drooping, and she could not blink that eye. She called her Ophthalmologist who saw her the afternoon of 29Jan2021 around 13:30-13:55. The Ophthalmologist said yeah something is going on with that eye. Her friend called his friend who is a Pediatric Neurologist that advised her to go to the emergency room. She was seen in the emergency room of (Hospital name withheld) around 17:00 on 29Jan2021. She was not admitted to the hospital at that time; but was evaluated and treated. She Bell's palsy outcome: she is doing so much better. She still has a hard time blinking her left eye, she still cannot blink her bad eye: left eye, without also closing her good eye: right eye. She is not drooling, she can drink without drooling. Her smile is still just a little crooked. She was given 2 prescriptions in the emergency room which were Prednisone and Valtrex. On 29Jan2021 in the emergency room they did tests including testing her heart with EKG; X-ray of her heart or lungs or something; took blood tests; and continuously took her blood pressure. There were no notable or abnormal results of any of those tests. They wanted her to go see her doctor last week but she did not have a chance to do so. She has an appointment with her primary doctor on Monday coming up. She has not yet seen her primary doctor about this. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None. The event Bell's palsy require a visit to Emergency Room, no to Physician Office. The patient was not hospitalized. No Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient underwent lab tests which included her heart with EKG; X-ray of her heart or lungs or something; took blood tests; and continuously took her blood pressure, all with no notable or abnormal results of any of those tests on 29Jan2021.

Developed itching and redness all over body. Eyes itchy and developed hemorrhage; Jaw pain. Patient had COVID-19 a few months ago.

The night of the vaccination, I experienced icy cold hands and feet throughout the night. I had to get up twice to put additional blankets on the bed, even though the house was heated as usual. I also experienced frequent muscle spasms and cramps in both legs throughout the night. The following day, Feb 18, 2021 and today, Feb 19, 2021 I have been very low on energy, simply sat all day. Experienced lower than usual blood pressure (98/84 w/ 127 heart rate, 89/71 w/ 77 heart rate. Currently feeling normal at 4:25 pm.

to ER on 2/19/21 breathing difficulty, hoarse voice , chest pain, skin itchy, headache, edema, body joint pain, elevated B/P

Redness on the thighs, legs, and chest. very little redness on my arm(s). I was watching tv 3 days after receiving the vaccine and my palms were suddenly blue and I could see every vein in my hands and fingers. they were cold and color returned after submerging them in warm water.

Patient was given the vaccine and waited the recommended time (15 minutes) after the administration of the vaccine and did not report any reaction at that time. Approximately six hours after the injection, she suddenly noticed she was having trouble breathing, could not catch her breath, and a call was made to 911. She was transported via ambulance to the hospital, where she remained for a week.

Per NP note, "...presented to vaccine cancer center to receive first dose of COVID 19 vaccination. First dose of Pfizer vaccine (Lot # EN6202) administered. Immediately after administration, Pt complained of acute mid-sternal chest pain described pressure. EKG completed, Pt observed for an additional 20 minutes, reported spontaneous resolution of symptoms. Prior to discharge pain completely resolved, lungs clear to auscultation , cardiac exam with normal S1 & S2,no rubs, gallops or murmurs. Pt admitted to being anxious, has a documented history of white coat syndrome."

has sporadic a-fib (at baseline); She stated she was in real bad stroke territory; she felt like she was going to faint; Her blood pressure was 220/97; tingling in her hands and feet; felt like brain sizzling like it was frying/going to faint; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, first dose) solution for injection intramuscular in the left arm on 06Feb2021 at 09:30 (at the age of 79-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing sporadic A fib (atrial fibrillation) for 6 years know about; allergy to polyethylene glycol in 1985 (she had difficulty taking birth, control pills and they found out it was the coating PEG in); cerebrovascular accident prophylaxis; in 1985 She had difficulty taking birth control pills and they found out it was the coating PEG in it. She had an allergy to this where she broke out in bumps on her fingers and mouth and had itchy eyes, a full blown allergy; and when she was 45 going through menopause. Concomitant medication included apixaban (ELIQUIS) for A fib and cerebrovascular accident prophylaxis. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 06Feb2021, the patient had sporadic a-fib (at baseline) then put in a medical van requiring emergency room visit. The patient stated, She stated she was in real bad stroke territory, felt like she was going to faint (6 minutes after vaccination), blood pressure was 220/97, tingling in her hands (6 minutes after vaccination) and feet and felt like brain sizzling like it was frying/going to faint (6 minutes after vaccination) on 06Feb2021. Lab tests included blood pressure on an unknown date high 150s and never lower than 187, then on 06Feb2021 was 220/97, on 09Feb2021 was systolic blood pressure 180, then on 10Feb2021 had gone down. The outcome of the events atrial fibrillation and feeling unwell was recovered on 06Feb2021, after 3 hours. The outcome of the events stroke, faint and tingling of extremity was unknown. The outcome of the event blood pressure was 220/97 was recovered on 10Feb2021.

Pt developed a flushed feeling, numbness in hands and palpitations(heart racing) several minutes after injection. Symptoms slowly subsided after 20-30 minutes of observation. HR: 100, SBP: 150, SP02: 99. EMS services/hospital evaluation was offered and pt declined. She elected to go home with her husband as the driver with a plan to self monitor at home.

After patient completed 15 minute waiting period post vaccination, she had almost left the clinic and noted that her nose was "running". She proceeded to have a gushing nosebleed that lasted approximately 1 hour. When we noted that the bleeding was continuing, we called her grandson to pick her up and take her to the ER. Called the ER at 6:15 pm and pt still there being evaluated.

shot started to hurt; blood pressure was gone up; Fever; my head feels like it is going to explode; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318) solution for injection, via an unspecified route of administration on 29Jan2021 at 08:30 at single dose for COVID-19 immunization. The patient has a lot of medical conditions (unspecified). Concomitant medications included unspecified medications. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 (lot number: EL3286) at single dose for COVID-19 immunization and experienced fever. The patient reported that she had her shot this morning (29Jan2021) at about 08:30 and towards evening, the shot started to hurt and so she wanted to make sure that it didn't go against anything, and put a little ice on it or maybe it was worthless on ice on certain situations after the fact that she thought this was too late. She wanted to make sure she could do that. The patient's blood pressure also went up on 29Jan2021. She was taking several different medicines for blood pressure. She took them already tonight. She was hoping that she will be feeling a little bit better. Sometimes, she gets a little fever on Jan2021, also like maybe 99 (unspecified). She just wanted to know if any of the medications were good or not for the shot. The patient was asking whether the drugs interacted. The patient also reported that when she took her first shot, she had a little fever and asked what she could take for it. An agent stated that she could take paracetamol (TYLENOL). The patient mentioned that she took her pills, otherwise, her head felt like it was going to explode on Jan2021. She took her high blood pressure medicines. She has three medications namely clonidine, losartan and propranolol. She has a lot of medical conditions that was why she was calling because she takes other medications. The outcome of the events was unknown.

pain in her hand/ lower part of each finger hurt; joint pain in right hand; bled quite a bit; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9263), intramuscular on 27Jan2021 (at the age of 79-years-old) as a single dose in the left shoulder for COVID-19 vaccination. Medical history included shoulder surgery about 10 years ago and she lost use of her thumb and index finger, the nerve comes from the shoulder; her hand might be numb and stiff, often but not every morning from an unknown date. Concomitant medications were reported as she is on medication but nothing she feels is relevant. On 03Feb2021, the patient experienced pain in her hand and all the lower part of each finger hurt for about 5-10 seconds, joint pain in her right hand lasting 10-15 seconds, it did not last very long; and she bled quite a bit stating she thinks she got it right in the vein on 27Jan2021. The pain happened about four different mornings but has not had pain "since Friday" and that was lighter sharp pain with no numbness. The clinical outcome of the event bleeding was unknown; pain in extremity and joint pain was recovered on 12Feb2021.

Had a Herpes Simplex virus that was dormant unless I get excited; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; My heart felt like rush; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Have Covid tongue; symptoms got progressively worse; feeling just kind of bumped out; This is a spontaneous report from a consumer (the patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809), via an unspecified route of administration on 10Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization. Medical history included cholesterol. Concomitant medication included rosuvastatin calcium (CRESTOR). The patient previously took Aspirin (e.c.) about 10-15 years ago and experienced anaphylactic reaction, Lyrica about 10-15 years ago for neuralgia and experienced hypersensitivity. The patient reported that on 10Feb2021, she got the vaccine. When she first obtained the vaccine, she was put in a holding situation in regards to having any reaction. She was sitting there about 10-15 minutes, and the first reaction was a numbing on left side of her face and her eye, her jaw and then her left arm was tingling, then she developed a taste of metal in her mouth; had a very salty taste along with the metal taste in her mouth; her mouth became dry. Her heart felt like rush. The "EMT" guy was there, he watched her. So, she sat there for a while. She went home and her symptoms got progressively worse. It was almost an immediate reaction. She started to get an ache in her left eye/pressure in her eye, and feeling just kind of bumped out. Immediately, after she got the vaccine, she had a very salty taste along with the metal taste in my mouth. When I came home, my mouth became dry. The patient reported that she still have a salty taste in her mouth and have "Covid tongue". The patient also reported that she had a herpes simplex virus that was dormant unless she get excited and it has been down for a long period of time. The patient reported that "I am afraid to take my second dose". The patient did not receive treatment for the events. She stated " I just thought it would go away". The clinical outcome of the event salty taste in her mouth was not recovered. The clinical outcome of the remaining events was unknown.

nearly fainting; Head ache; fatigue; upset stomach; vomiting; chills; new mouth sores; painful arm; This is a spontaneous report from a contactable consumer (patient) reported for herself that a 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9365) via an unspecified route of administration in the right arm on 15Feb2021 12:00 AM at single dose for covid-19 immunisation. Medical history included allergy to bees and wasps. The patient was not pregnant at the time of vaccination. Concomitant medications included rosuvastatin and olmesartan medoxomil. The patient previously received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration in the right arm on 21Jan2021 12:00 AM at single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After receiving the second dose, the patient experienced headache, fatigue, upset stomach and nearly vomiting, chills, nearly fainting and new mouth sores, painful arm on 15Feb2021 13:15. No treatment was received for the adverse events. The patient has not been diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. Outcome of the events was recovered in Feb2021.

Lost part of my vision and it only lasted for three to four minutes; mini stroke/ TIA; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2(Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9284, Expiration date: 31May2021), via an unspecified route of administration at the left arm on 11Feb2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11Feb2021 7pm, patient went to get something to open the can of soup but when she went into the pantry, she lost part of her vision and it only lasted for three to four minutes. The patient's daughter who is a neurologist thought it was the mini stroke or TIA (Feb2021). The doctor was setting up the sonogram for her arteries and her neck and also for her heart and said she might have to rely on a pacemaker. The outcome of the events was unknown.

short of breath; nose bleed/lost a lot of blood/bleeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9263 and expiry date unknown, via unspecified route of administration on 26Jan2021 at single dose for Covid-19 immunization, and eicosapentaenoic acid ethyl ester (VASCEPA), acetylsalicylic acid (BABY ASPIRIN); both via unspecified route of administration from unspecified date to 31Jan2021 at unknown dose and frequency for unspecified indication. Medical history was none. Concomitant medication was not reported. The patient had taken the first shot of the Pfizer shot on 26Jan2021 (Tuesday) and the patient seemed to managing it pretty well, she got short of breath one night (unspecified date) but in general, she felt okay. But several days later, 5 days later Sunday (31Jan2021), on Sunday morning she felt okay, what happened was she leaned a little bit, she bent down to wash her hands in the sink and she had a huge nose bleed, it was nothing like she ever had before, she was just wiping, spurting a lot of blood so this was 5 days. It was the morning of the 5th day and they had to call an ambulance to take her to the hospital and then she left the hospital. The patient had lost a lot of blood in the ambulance, they said they had never seen so much blood, they could not stop it, they kept giving her towels and the same thing in the hospital, in the emergency room. The patient was just bleeding over everywhere. The patient informed that for the last several years she has been having one baby aspirin and has been taking for the last few months or two, two or four Vascepa which was a fish oil supplement that can thin the blood but she has never had anything like this and they said go to her ENT, and she went up going ENT, and first time she went she would not take out the packing. The patient informed that it was too severe for her to take out the packing and, when she went back with her following time she took some of the packing and it started to bleed again and she cauterized it in a lot of places and you know would wait and do it again. And then she end up putting some kind of bandage that was going to help the blood clotting. Now, she has been subsequently going back to her and it was still in the very end of. The patient informed that she was still passing some very small blood clots, it has not even stopped. The patient informed that she was on 19 days passed already, since she had the bleed. The patient was very concerned. The patient informed that she was supposed to get her second vaccine in 2 to 3 days, Tuesday and she thought that this was the very bad experience that she had. The patient wanted to know if the aspirin and fish oil could have contributed to this, she stopped these as of 31Jan2021. The patient was talking to her daughter and her daughter has a friend whose mother lives in the same area and had her first Pfizer vaccine and had a small nose bleed right afterwards and then when she has second vaccine, she had another, a very bad. The patient informed that her daughter and a friend of hers said that a similar reaction occurred to her mother after the first dose of the Pfizer vaccine, she had two small nasal bleeds and right afterwards, when she took the second vaccine she had a very big one, like hers, where she had to be taken to the hospital. The patient was concerned, she has been told that the response to the 2nd vaccine was stronger than the first. The patient further informed that she had no nose bleed like this before, like her husband was a physician, that she never had anything like this before, this was very serious kind of situation to happen, and this after the very first vaccine that she had. She had a very severe nosebleed, she had to go to the hospital to stop it. She was on a baby aspirin and some fish oil as well. The patient informed that she wasn't warned that this could thin her blood, that this was enough of a dose to do anything to create this deluge of bleeding. The patient informed that she was few days out from getting her second shot and she had stopped the baby aspirin and the fish oil about three weeks ago. The patient informed that she was not going to take second. The patient wanted to know how long she was going to wait, how long she was going to test her antibody and see that she don't have any more antibodies and will go take the other brand vaccine. The patient added she was reporting that she had a terrible nosebleed and wanted to file a safety report. The patient wanted to know that if she choose not to get the 2nd vaccine, because of her worry of having this reaction again, how long would it be before she could get another vaccine; how long can she wait to get the second dose, or can she get a second dose from another manufacturer. The patient was requested to contact physician. The action taken in response to the events for eicosapentaenoic acid ethyl ester (VASCEPA) and acetylsalicylic acid was permanently withdrawn. The outcome of the events was unknown.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the BNT162B2 and the event nosebleed cannot be excluded. This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021191054 same reporter, similar drug/events, different patient

Patient complained of feeling dizzy 10 minutes after receiving vaccine. Elevated blood pressure. Was seen in the Emergency Department related to her ongoing elevated blood pressure, headache, and dizziness.

The patient had near-syncope and confusion about 2 minutes after receiving a vaccine. She is diabetic and hadn't eaten at all yet and thought it was more of a metabolic derangement. She was sent to the ER.

COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Pfizer on12/30 and 1/21 . Patient is admitted to hospital on 3/7 for atrial fibrillation with rapid ventricular rate

15 monitoring status. Syncope episode after release from Monitoring (outside). Escorted back to monitoring area in w/c. Evaluated by Paramedics. SaO2 98% P 110 BP 142/84. 2:50PM feels "normal" hold until 3 and re-evaluate. 3:05mstands w/o dizziness. W/c escort to car. Home

Starting about middle of my chest up to my neck it started to get little bit bubbles on it and now it's just burning like crazy and it's starting around my ankles; It's like my chest is burned; This is a spontaneous report from a contactable consumer (patient). A 79-year-old Female patient (also the age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 29Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included Atrial fibrillation (AFib) and back surgery (reported as: I am recovering from very serious back surgery) both from an unknown date and unknown if ongoing. Concomitant medication included methotrexate (reported as , it's a little cancer pill (Further clarification was unknown if consumer have cancer, hence cancer was not captured in medical condition), once a week), tocilizumab (ACTEMRA) (reported as I am on IV Infusions every 4 weeks and the name of it is Actemra), apixaban (ELIQUIS) (reported as I am on Eliquis because I am AFib, heart), and then another heart medicine plus all the patient's 'vitamins' (unspecified). The patient previously took oxycodone and experienced allergy (reported as I can't take any of those drugs, I am allergic to all that stuff. Yeah I can't take any of that pain medicine (Unspecified Medications)). The patient stated that: "I was calling about the, I had my first shot for the virus and on my chest, starting about middle of my chest up to my neck it started to get little bit bubbles on it and now it's just burning like crazy and it's starting around my ankles. Does that have anything to do with that shot?" The reporter confirmed that the next shot is due on 22Feb2021. The patient added that, "Actually last week they were really light, and they just keep getting worst. I was actually going to call my doctor tomorrow because I was concerned about getting this injection anyways because of my history on having reactions to medicine. I can't take any like Oxycodone or like any of those (also reported as "I can't take any of those drugs, I am allergic to all that stuff. Yeah I can't take any of that pain medicine (Unspecified Medications). No, I don't have anything like that."). I can't take any of those drugs (Unspecified Medications). And she said she thought it would be alright but I am recovering from very serious back surgery and so I have had a hard time with that. So, I thought I should call and see if I should get my second injection or if I should just let it go." It was also reported that: "Yes, it's like my chest is burned." Consumer stated for the treatment, "The only thing I put on was Benadryl cream. To keep it from 'itching'." The patient asked "Should I get the second injection?" The outcome of the events was unknown.

Unexpected chest pain along the left side, especially painful the first night. Light pain lasting 10-15 minutes randomly usually once per day on days following date of vaccination. Patient states that it did not feel like heartburn. Patient has never had a heart attack and cannot compare the two experiences. Expected right arm pain at injection site that subsided after a day or two.

79 y/o F pt presents w/ fatigue and cough, onset 10 days. Pt states she received her first dose of the COVID-19 vaccine on 3/2/2021 and reports experiencing sx of HAs, sore throat, bloody mucus, cough, fatigue, and body aches; pt states sx subsided except for the fatigue and cough. Pt reports having taken zicam and coricidin w/ slight relief but states she stopped taking those 5 days ago. Pt reports taking an antihistamine and doing nasal sprays w/ some relief as well.

Developed an Acute nonoocclusive DVT in left leg 10 days after my first vaccine. Decided to decline my second vaccine. I do have a history of having blood clots, but last one was 32 years ago.

Dizziness; feels unsteady at times; nearly passed out/totally passed out; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EN6198), via an unspecified route of administration, administered in Arm Left on 27Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history was reported as none. There were no concomitant medications. It was reported that the patient received first COVID shot Saturday. She confirms the Pfizer COVID 19 Vaccine. She says 24 hours after she had the shot she nearly passed out, she got really dizzy and someone asked, are you okay, and she said no and they caught her before she totally passed out and she sat down. She is still having waves of dizziness and she feels unsteady at times, not every second but she is a little scared to drive a car. She just thought someone should know that. It was reported that dizziness began the next day on 28Feb2021 around 3pm. She closes her eyes and says she doesn't want to look at that. It is ongoing but it is not so bad after she gets up. It seems to have lessened after about 3 pm yesterday it is bothersome. She confirms it is ongoing but improved a little since it began. The outcome of the event dizziness was recovering, while unknown for the other events was unknown.

blood sugar raised up; being unbelievably freezing cold; This is a spontaneous report from a contactable consumer (patient self). A 79-year-old female patient received the second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 09Feb2021 10:30 (Lot number was reported as ELO1265 or EL01265, the patient was not sure if the third digit was letter or number; unknown why this Lot was 7 digits when first dose Lot was 6 digits) at the age of 79 years old, at single dose for covid-19 immunisation. Medical history included diabetes from 2018 and ongoing, family Medical History includes: All diabetics stage I and stage II, ongoing scoliosis, 60 degrees of scoliosis diagnosed when she was age 75 years; assumed it was congenital, ongoing asthma when she was around 40 years of age, ongoing thyroid disorder when she was around 45 years of age, diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity, back pain, celiac disease. Concomitant medications included insulin lispro (HUMALOG) taken for diabetes from 2019 and ongoing; sitagliptin (JANUVIA) taken for diabetes from 2019 and ongoing, because of celiac disease-she cannot take others; she wondered if getting vaccine may have knocked this out of her system and it is having to build back up, prednisone taken for back pain from 27Jan2021 to 01Feb2021, She knew prednisone can increase blood sugar levels. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration, administered in arm right on 19Jan2021 14:00 at the age of 79 years old, at single dose for covid-19 immunisation, and previously took second shingles vaccine for immunization and described as a bruiser, she was really sick, the vaccination date of second shingles vaccine was reported as maybe 1.5 years before 12Feb2021. There is no other vaccination within four weeks prior to the first administration date of the suspect vaccine BNT162B2. No other vaccines were administered on same date with the BNT162B2. The patient experienced very high blood sugar levels and being unbelievably freezing cold on 10Feb2021 after she was administered the second dose. She called to ask if anyone else has reported very high blood sugar levels after getting the vaccine. Her normal blood sugar level in the mornings was about 122; normal blood sugar level in the evenings was about 180. She had not gone to physician's office, emergency room or been hospitalized for this event at this time. As long as she stayed under 300 and she was ok she knew. Blood sugar level was 164 on 10Feb2021 morning, exact time unknown, blood sugar level was 247 on 10Feb2021 evening, exact time unknown, blood sugar level was 182 on 11Feb2021 morning, exact time unknown, blood sugar level was 296 on 11Feb2021 evening, exact time unknown, blood sugar level was 172 on 12Feb2021 morning, exact time unknown. The patient had to use insulin lispro more than normal in response to very high blood sugar levels. Increased doses provided as took 13 units this morning: 12Feb2021; 14 units evening of 11Feb2021: Started with 10 units, but when got blood sugar level of 296 she took 4 more units. The patient experienced unbelievably freezing cold on 10Feb2021 about 13:00 or 13:30. She woke up around 13:00 or 13:30 and was unbelievably freezing cold. She was freezing. She wrapped up in a bathrobe, 2 blankets and her husband; took a couple of Tylenol and Benadryl and this event subsided. She recovered completely from event within about 1 hour of onset on 10Feb2021. Event described as the craziest thing. The events did not result in emergency room visit or physician office visit or hospitalized. The outcome of the event high blood sugar levels was unknown, outcome of the event unbelievably freezing cold was recovered on 10Feb2021. Information about lot/batch number has been requested.

I went to the bathroom and the next thing I know was that I woke up on the bathroom floor, I passed out for couple of minutes; Chills; Weak; Dizzy; Nausea; Sore arm; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 79-year-old, on 06Mar2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, on an unspecified date, as SINGLE DOSE for covid-19 immunisation. After taking the second dose on 06Mar2021, the patient waited for half an hour and there was no problem. The patient came home no problem. In the middle of the night, the patient woke up with chills, the patient know that is one of the side effects, she was okay and not worried about it. The patient took her temperature that was normal but then couple of hours later, she went to the bathroom and the next thing she knew was that she woke up on the bathroom floor, the patient passed out for couple of minutes. Then she went to bed and was very weak and dizzy and nausea. The patient didn't want to call right away or did not wanted to go to the emergency room. The patient called her friend because she got very nervous and she said come back to her house. The patient took a Benadryl (treatment) and came back home and slept few hours. The patient woke up this morning, felt pretty good and took Benadryl (treatment) and then came here of her friend house and took Benadryl (treatment) again few minutes ago and four hours later. The patient had several things like these like she was dizzy and had nausea. The patient felt okay now and she doesn't want to go to emergency room and she seems to be fine now. The patient was dizzy, nausea and passed out. The patient had a chills and experience sore arm. Outcome of the events was recovered in Mar2021. Information on the lot/batch number has been requested.

She has nose bleed 15 mins after the vaccine, while she was leaving the vaccine clinic. It stopped after a few minutes as she went back to do more observation. Her blood pressure (BP) was measured high at the time. then from March 5-22 she had 5 nose bleeds, some can be stopped after a few minutes, some took a long time (one time it took 30 mins or more, and bled maybe 120ml and lastly on March 22 at 4am, the nose bleed can't be stopped, we called the ambulance). She's been self monitoring her BP at home since March 5, they were all normal, and just once a bit lower than usual. Besides the nose bleed, she also has been experiencing more mild headaches and fatigues. All of the 3 symptoms are rare for her, especially nose bleed. We already tried to use humidifier, be gentle when blowing nose, not eating spicy food.

First and second day (1/21/2021 and 1/22/2021) after receiving vaccine: sore arm, slight fatigue. Fourth day (1/25/2021), extreme vertigo, nausea, vomiting, weakness, unable to stand. Husband called primary care physician who said I should go to ER immediately. Blood pressure elevated. Fluids administered. Chest X-ray, CT head. Morning of 1/26/2021,MRI brain w/o contrast. Later same day: MRA head, MRA head IAC w/ and w/o contrast. MRI IAC, MRV w/o contrast. Ultrasound carotid duplex bilateral. Diagnosed with Right Vestibular Schwannoma, benign, measures approximately 1.5 x 0.9 x 1 cm. Remained hospitalized until 1/27/2021 about 7:00pm. Follow-up with physician. primary care physician; (Otologist and Neurotologist,) and (Clinical Audiologist) at. Follow-up treatments will include consultations with above physicians, additional MRIs and CTs, and possible targeted radiation or surgery.

Stood up to go to the bathroom and could not put her right leg down; thought she was having a heart attack or a stroke or something; Fell on her right side; Cerebrovascular accident; Diarrhea; Nose running; Her calves were so sore, like having charley horse where her calf muscles were so tight it hurt; like having charley horse where her calf muscles were so tight it hurther calf muscles were so tight it hurt; her calf muscles were so tight it hurt; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 18Feb2021 (Batch/Lot Number: EN6201) as single dose for COVID-19 immunisation. Medical history included family history of glaucoma from 2019 (Her mother has Glaucoma); memory ain't that good (she puts everything on her calendar because her memory ain't that good); ongoing irregular heart beat since 2006 (periodically when she goes to the doctor they have her walk the treadmill and stuff like that); ongoing diabetes since 2011; and was allergic to Penicillin (as a kid she was bitten by a dog, she must have been about 12 years old, went to hospital they gave her a shot of penicillin, her head blew up, she looked like a monster, she went back they gave her Streptomycin). Concomitant medication(s) included brimonidine taken for glaucoma from 21Feb2021 to 01Mar2021; latanoprost taken for glaucoma; apixaban (ELIQUIS) taken for arrhythmia, and dyspnoea from 2019 and ongoing; and metoprolol taken for arrhythmia. The patient was administered with her first dose of COVID-19 vaccine on 18Feb2021. It went beautiful, she did not have any aftereffects or anything initially. On 01Mar2021, while in her own apartment she stood up to go to the bathroom and could not put her right leg down; she thought she was having a heart attack or a stroke or something and she fell on her right side. She went to the hospital where she was hospitalized overnight for observation and testing. MRI performed during that hospitalization had result of Cerebrovascular Accident-CVA. She also reported onset of diarrhea and nose running around 01Mar2021. When she went to the hospital on 01Mar2021 she was laying down, and when the doctor moved the blanket to test her legs her calves were so sore, like having charley horse where her calf muscles were so tight it hurt. The events were reported to have required a visit to the emergency room. They did not find anything else during hospitalization with testing. The only thing she can think of related to these events was the COVID-19 vaccine. She called to ask if she should or should not get the second dose of the COVID-19 vaccine as scheduled for 11Mar2021 relative to these events. She was scheduled for second dose on 11Mar2021, but she is scared because of events that occurred 01Mar2021. The outcome of the events diarrhea, "Nose running", "Her calves were so sore, like having charley horse where her calf muscles were so tight it hurt", "her calf muscles were so tight it hurt" was recovering, and for other events was unknown.

Individual reported sudden onset dry cough 25 minutes post vaccine. Reported some tightness to upper chest. Denied shortness of breath. Handled saliva and PO intake, coughing noted while trying to complete full sentences. No swelling or redness noted. O2 saturation 98%. 911/EMS called, nurse monitored until arrival. On EMS arrival symptoms moderately improved, individual refused further medical treatment or emergency services.

palpitation BP 182/86 /58 98%o2 after 10 minutes BP 174/84/56 99%o2 #20 no more palpitations when she left for home #21 left went home against medical advice - adviced to go to hospital for evaluation

It got to 217/99; I got really red; This is a spontaneous report received from a contactable consumer (Patient). A 79-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN5318), via an unspecified route of administration on 09Feb2021 at single dose for COVID-19 immunization. Patient's medical history included Cancer, asthma. Concomitant medications included letrozole taken for neoplasm malignant, gabapentin, montelukast taken for asthma. Patient received the first dose after half an hour the patient had such subjective symptoms as red, blood pressure had gotten very high after half an hour of Vaccination. It got to 217/99 having somewhat high blood pressure but not that high. Patient went to the emergency room at a hospital they put me on EKG machine to monitor my heart and took some blood samples. Benadryl was given as treatment. The outcome of the events was unknown.

Tightness in chest; dizziness; chills; headache; warm red injection site; warm red injection site; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old non-pregnant female patent received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm at the age of 79-years (non-pregnant at the time of vaccination), on 17Feb2021 at 01:30 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot number: EL8982), via an unspecified route of administration in left arm at the age of 79-years on 27Jan2021 at 01:30 AM at a single dose for COVID-19 immunisation. The patient received any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced tightness in chest, dizziness, chills, headache and warm red injection site on 17Feb2021. The seriousness of the events was reported as no. The patient did not receive any treatment for the events. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

presented with chest pain onset around 1800 this evening. She describes it as "an elephant sitting on [her] chest" that began suddenly and was constant until she received pain medicine in the ED. She had associated shortness of breath and nausea. She did receive her COVID-19 vaccine today. She denies fever, chills, cough, vomiting, abdominal pain, diarrhea, constipation, urinary sx.

Syncope. about twelve hour later she developed some chills and fever and dizziness which was not unexpected. Overnight into Saturday morning 3/27/2021 however she fell a few times and believes that she did pass out. She injured her face in the fall but no other injury and the injuries or not severe. By our appointment on 3/29/2021 She is feeling a little bit fatigued at this point but otherwise back to her normal self.

Patient began having symptoms of pain in upper R leg on 3/16/21. Presented to ER on 3/20/21 and was discharged on lovenox. Presented back on 3/21/21 after venous duplex - now being treated with Eliquis.

patient had dizziness about 5 minutes after the vaccination, patient felt like she needed oxygen and so we decided to contact ems once she stated she was having feelings of passing out. patient was seen by ems an ekg was run, blood pressure was 200/100 and the ems advised her that this may be a panic attack related to getting the vaccine that the increase in blood pressure was not a hypertensive emergency. patient then chose to stay and wait for her daughter to come pick her up. her blood sugar was also taken and it was 99 within normal range.

Patient was a 79 yo F who presented to hospital on 1/29/2021. On admission patient was severely hypoxic with symptoms of SOB, cough, and severe dyspnea . The patient was COVID-19 positive on admission with symptoms starting 4 days prior to admission. Patient's labs on admission showed elevated ferritin, CRP, and d-dimer. Patient was diagnosed with COVID-19 infection with sepsis and respiratory failure with hypoxia. On arrival to hospital patient's O2 sats were in 60's and improved to upper 80s after nebulizer treatment. Patient was started on azithromycin 500mg once daily for 3 days, ceftriaxone 2g once daily for 2 days, dexamethasone 6mg once daily for 3 days, zinc 220 mg once daily for one dose, and duo-neb 3ml q4h for 3 days. Patient's respiratory status declined and was placed on BiPAP and comfort measures. The patient continued to decline until her passing on 2/3/2021.

my arm is a little bit sore; shivering; I was so cold; I ached all over; I am getting the flu; I could not walk, it was like I was drunk; pulse rate was like 116; O2 stat was like 98 percent; headache; diarrhea; short of breath when I walk up to the stairs; blood pressure, it was 66 over 48/my pressure came up to 80 over 62 or something/pressure came up to like about 103/my pressure was like 120, the systolic was 120 and diastolic was like 70 something/my pressure was in the 90's; This is a spontaneous report from a contactable Nurse (Patient). A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration on 12Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included High cholesterol. Concomitant medication(s) included rosuvastatin (40, not clarified further); aspirin [acetylsalicylic acid] (ASPIRIN) (81, not clarified further); zinc (50, not clarified further); alendronate sodium (Generic Fosamax) and Multivitamin. Historical Vaccine included First dose of BNT162B2 on 22Jan2021 for COVID-19 immunisation and experienced sore arm (The sore arm went away, it descended in about 12 hours and gracely went away), got really tired and itching (It started itching, okay no problem). The patient experienced my arm is a little bit sore on an unspecified date, shivering on an unspecified date, I was so cold on an unspecified date, I ached all over on an unspecified date, I am getting the flu on an unspecified date, I could not walk, it was like I was drunk on an unspecified date, pulse rate was like 116 on an unspecified date, O2 stat was like 98 percent on an unspecified date, headache on an unspecified date, diarrhea on an unspecified date, short of breath when I walk up to the stairs on an unspecified date, blood pressure, it was 66 over 48/my pressure came up to 80 over 62 or something/pressure came up to like about 103/my pressure was like 120, the systolic was 120 and diastolic was like 70 something/my pressure was in the 90's on an unspecified date; all (non-serious). Reporter (Nurse) stated "I had my first Pfizer vaccine on Friday, I think 22Jan2021 and the only thing I have was the sore arm and got really tired okay and the sore arm went away, it descended in about 12 hours and gracely went away, after that it started itching, okay no problem. I had my second vaccine this past Friday at about 8 O'clock between 8:15 in the morning. As the day went on I felt my arm is a little bit sore, no problem. Okay I went to bed and about 3 O'clock in the morning, I woke up and I was shivering, I was so cold and I ached all over and I said okay I am getting the flu, went back to sleep, by the time I got up in the morning about 6 o'clock the aching was gone but I could not walk, it was like I was drunk. I have a little dog and she was barking to go out and it was like 0 here so I sat there for a minute and I left her out and she started barking, to bring her back and I could not walk, I kept walking into the walls and my house was just this dark, I thought it's so dark in my house so I got my little dog back in, sat down and again and I thought what, maybe I will take my blood pressure, so I did and it was 66 over 48 so I though okay, so I started drinking, I thought I got to eat, I got to drink, so I get that, my pressure came up to 80 over 62 or something, my pulse rate was like 116, my O2 stat was like 98 percent so that was not a problem. So, I ate and drink, as the day went on the pressure came up to like about 103, gradually last night by the time I went to bed, the only thing I had was a little bit of headache, I did not thought enough to take anything for, when I went to bed, my pressure was like 120, the systolic was 120 and diastolic was like 70 something, this morning when I got up my pressure was in the 90's. I was not taking any blood pressure medication, I mean I have but doctor took me off long time ago, I did not I mean I have no aches, I have no pains, I have nothing just a little bit of headache, not even enough to bother me, every now and then I think about it, I also, I mean I thought I have got to the bathroom, I had diarrhea terribly, something, I did not know if any of this is from the vaccine. I have not called my primary, I thought I called him tomorrow I mean I am fine, I am little short of breath when I walk up to the stairs but that is nothing unusual." Causality: Reporter stated "I don't know, I am thinking it does I never had anything like this before but you know I don't know, I don' know, I am just reporting it, I am 79 so I don't know how much this is, I don't know." When probed from where reporter got the vaccine, Reporter stated "I got it the first one at (Institute name)." LOT# of COVID-19 Vaccine administered on 22Jan2021: Reporter stated "You know it's not on my little card, just the LOT# of second one is on here. The first vaccine was 22Jan2021, the second one was 12Feb2021." Reporter provided the LOT# as EM9809 for second shot of COVID-19 Vaccine administered on 12Feb2021 and did not have LOT# of the first vaccine administered on 22Jan2021. Date of side effects: Reporter stated "I think when I started having difficulty was the morning of 13Feb2021." (Not clarified further). Still experiencing side effects: Reporter stated, "No, finally last, I felt yesterday I felt like I kind of had the flu, I have got to get the flu, but it was not enough to stop me, I kept going, I went to work, I did all my stuff, this morning I got up I felt fine." (Not clarified further). Treatment: Reporter stated: No, did not take anything, no. Other medications: Reporter stated "the generic 10 mg." (Not clarified further). Reporter stated "No I was just going to report this, like I said I don't know if this is a problem or not. I have never had anything like this before, I thought this is something you needed to know." Reason of delay: Daily spike of incoming calls due to COVID-19 Vaccine. The outcome of all events was unknown except for event I ached all over, outcome was recovered on an unspecified date.

Went into A Fib; Went into A Fib; thirsty; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) at the age of 79-years-old, via an unspecified route of administration in left arm on 19Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included allergies to penicillin, arthritis, and episodic atrial fibrillation (AFib) in which she had 3 episodes in the last two years. The patient has no COVID prior to vaccination. Concomitant medications included apixaban (ELIQUIS), diltiazem, colecalciferol (VITAMIN D), and bifidobacterium lactis (PROBIOTIC). The patient has no other vaccine in four weeks. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) at the age of 79-years-old, via an unspecified route of administration in left arm on 22Feb2021 at 11:00 at single dose for COVID-19 immunization. The facility the vaccine was administered was public health clinic/veterans administration facility. The patient went into AFib on 19Mar2021 at 23:45, 12 hours after receiving the dose (as reported). She was told to drink plenty of liquids following the shot, which she did because she was so thirsty. The patient was in AFib for about 18 hours until it resolved into sinus rhythm. She wondered if there was any association with the vaccine and heart rhythm. The patient did not receive any treatment for the event "went into A Fib". She was not tested with COVID post vaccination. The outcome of the event "went into A Fib" was recovered on 20Mar2021 at 17:45 and unknown for the other event.

13 days after receiving the second dose I was walking my trash can to the street and I could not breath very well. I went to the Urgent Care and was told I had blood clots in my lungs. I was hospitalized and given treatment for the blood clots.

Shortness of breath and chest pain began on Wednesday 02/10/2021 (2 days after vaccine given), Breathing and chest pain severe enough to go to Emergency Room on Saturday 02/13/2021 ( 5 days after vaccine given). CT scan in Hospital showed blood clotting in both lungs. Was kept overnight in hospital and released on 02/14/2021 with prescription for Eliquis (blood thinner).

she was bleeding (from the eyebrow, it broke a little bit); been laying in bed, is weak, doesn't want to get up; she does not help herself as if she had no movement in her body; Doesn't want to eat; fell a couple of times from bed and chair; she hit her eyebrow and broke it a little bit; Weakness; This is a spontaneous report from a contactable consumer reported for a patient (his wife). A 79-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6200) via an unspecified route of administration on 25Mar2021 10:00 and first dose received on 4Mar2021 ( LOT:EN6201) both as single dose for COVID-19 immunization. Medical history included dementia. The patient's concomitant medications were not reported. Patient received her first dose within 4 weeks prior to vaccination. Patient experienced bleeding (from the eyebrow, it broke a little bit) on 25Mar2021, fell a couple of times and doesn't want to eat. On 26-MAR-2021, Patient been lying in bed, weak, doesn't want to get up, Patient was fell out of bed and she does not help herself as if she had no movement in her body. The outcome of the events she was bleeding (from the eyebrow, it broke a little bit) was unknown and the outcome of the other events was not recovered. Follow-Up (29Mar2021): New information from a contactable consumer followed: Clinical information included new events, outcome details and historical vaccine.

Developed significant bruising within minutes/hours and has had significant limb pain for 11 days. Also radiating down arm and up into chest and back

Pt developed SOB 2 weeks after 2nd vaccine, admitted with saddle PE. No history of VTE. Treated with Eliquis and recovering well.

I went to the hospital with palpitations; lightheadedness; She had terrible back pain in center of back; She felt achy; fatigued; back discomfort; she had a lot of shoulder, under arm, and left breast swelling; she had a lot of shoulder, under arm, and left breast swelling; she had a lot of shoulder, under arm, and left breast swelling; Her breast felt like it weighed 60 pounds and ached.; had the worse headache; Her shoulder blade was tender; neck pain; achy feeling was ongoing with her muscles; achy feeling was ongoing with her legs; legs felt rubbery; short winded; sweaty; she felt clammy and hot.; she felt clammy and hot.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration in left shoulder on 11Feb2021 at age of 79-year-old at single dose for COVID-19 immunization; methylprednisolone (MEDROL, Tablet), orally from 20Feb2021 to 26Feb2021, at 4 mg, by mouth, frequency was different based on the day, from 27Feb2021 to an unspecified date, at unspecified dose for swelling, the back. Medical history included thyroid and pericarditis fluid. Family history included brother had heart disease. There was no prior vaccinations within 4 weeks. Concomitant medication included levothyroxine sodium (SYNTHROID) ongoing for thyroid for 20 years. Historical vaccine included first dose of bnt162b2 in left shoulder on 21Jan2021 (Batch/lot number: EN6201) for COVID-19 immunization with no side effects. The patient had her 2nd Pfizer vaccine dose on 11Feb2021 and received a "medrol pack" on 20Feb2021 for "shoulder, back and neck pain. She have felt lousy for 4 weeks. She went to the hospital with palpitations and it probably was from the 2nd pack of methylprednisolone, she was prescribed after the 1st pack did not really help her pain. She haven't been sick or had a cold for 25 years and the 2nd dose through her for a loop. She stated her daughter called her and she said that her doctor told her that her vaccine may not be effective and she may not be protected because she took methylprednisolone. The patient received the second vaccine on 11Feb2021 and she had a lot of shoulder, under arm, and left breast swelling. The patient mentioned she went to her doctor because after calling the COVID hotline they said they had cases where some of the vaccine had seeped into the lymph nodes. She was told to have her lymph nodes. No patient demographic details provided regarding those other patients who had the vaccine seep into lymph nodes. She went on to explain she went to the doctor, but the doctor said there were no problems with the lymph nodes. On 13Feb2021, she felt achy and fatigued, back discomfort. The lightheadedness occurred on 18Feb2021. The doctor gave her a high dose of the methylprednisolone 4mg pack for a week. 16 days later on 27Feb2021 it had not touched the discomfort in back, fatigue and lightheadedness and gave her another pack of methylprednisolone. She also had heart palpitation, was sweaty and went to the Emergency Room. The patient mentioned she took a low dose of levothyroxine sodium (SYNTHROID). She asked the doctor about the methylprednisolone being taken after the shot. The patient heard it diminished the effect of the shot, that she may not have as much protection. She had called the COVID hotline to address this issue and they said people who were on chronic steroid therapy had no problem as far as they know. The patient asked if she was protected because she had the methylprednisolone pack the first one within 9 days after shot and a second pack 16 days later. She took a low dose of generic levothyroxine sodium every day. She commented she was concerned with the drug interaction and wanted to make sure still protected. She was informed by individual who answered COVID hotline she felt like she was still protected because others have been on chronic steroid therapy. Shoulder swelling started a couple day after the second shot, explained it was there or about around 13Feb2021. Her shoulder blade was puffy and tender. The swelling went into the arm and breast. Her breast felt like it weighed 60 pounds and ached. That took a while to go away. The patient explained initially it was also there or about around 13Feb2021 when she noticed she was so fatigue and had the worse headache (Feb2021), she never got nauseous. Her shoulder was still swollen a week ago as of 09Apr2021. She went to a chiropractor for an adjustment and the chiropractor said shoulder was still a little swollen. She had terrible back pain in center of back on 18Feb2021. It was so much that she was afraid something else was going on. The patient stated the swelling it was ongoing up until a few days ago as of 09Apr2021. She still had puffiness around that area when went to chiropractor. For the back discomfort she went to chiropractor for adjustment. She was unsure when that discomfort went away. The achy feeling was ongoing with her muscles and legs until last week as of 09Apr2021 when she started to feel better. Her legs felt rubbery. Her muscles felt achy. She felt better as of 09Apr2021. It had gotten better within the last week as of 09Apr2021. The fatigue was ongoing until last week as of 09Apr2021. The patient felt so bad for month and had no idea what was going on. Her lightheadedness went away last week as of 09Apr2021. She commented she did not want to blame all of this on the shot because she did not know what methylprednisolone did to her. The patient confirmed she had back discomfort. She still had some back discomfort. She started to fell short winded a week before the heart palpitations appeared really bad on 21Mar2021. She did not feel short winded anymore, but she was unsure when that stopped. With her heart palpitation she felt clammy and hot. Therefore, she wen to the ER. The heart palpitations gradually got better, and probably stopped totally last week as of 09Apr2021. She mentioned she had a headache for a good month after the second shot. It started either the 13Feb2021 or 14Feb2021. She stated all her symptoms were getting much better since last week as of 09Apr2021. There was no other treatment beside the methylprednisolone for her symptoms. Therapy start and stop date of methylprednisolone captured as confirmed by reporter in formal field, unable to clarify further. The patient confirmed all had been discarded and no lot/exp/NDC to provide. When she was in Emergency room, they did two EKG, drew blood work for the heart, chest x-ray back and front, and verified vital signs which were all good. She went home that same night on 21Mar2021. She went back to doctor on 05Apr2021 and did another chest x-ray and another echocardiogram and everything was fine. The event heart palpitation required a visit to emergency room, the patient was not sure if from the vaccine or methylprednisolone. The patient's heart rate got to 120, her normal was 80. The relevant Tests on 21Mar2021 they did Chest x-ray back and front, a couple EKG and blood work. The patient went back about a week ago as of 09Apr2021 because she was still not feeling great. They did an EKG, ordered echocardiogram and chest x-ray which were done on 05Apr2021. Test results came back on 08Apr2021. She had pericarditis fluid in the past and that's what they were checking for with the echocardiogram. The lab tests and procedures for investigation on 21Mar2021 included: chest X-ray: negative, EKG: negative, blood work: negative, negative. The action taken in response to the events for the methylprednisolone was unknown. The outcome of achy, back discomfort, back pain was resolving, the outcome of short winded was resolved in 2021, outcome of headache was resolved in Apr2021, the outcome of other events was unknown. Information on the batch number has been requested.

"Pfizer-BioNTech COVID-19 Vaccine EUA" - received first dose 2/25/2021 and second dose 3/18/2021 Patient wint intermittent persistent occipital headache for 2-3 days. Pain was rated 8/10. Also with bilateral lower extremity rash without itchiness persisting for 2 days. no vision change, no photophobia. Denied any fever, chills, SOB, cough, loss of smell or taste, myalgia, nausea, vomiting, diarrhea, weakness or any focal neurological deficit. Admitted for ITP (also with epistaxis and severe low platelets, hyponatremia, acute cystitis without hematuria. No chest pain, no GI bleed.Treatments included 2 units PRBC transfusion (4/6), plateletpheresis (4/6), dexamethasone IV (changed to prednisone oral on 4/7), IVIG infusion from 4/5 to 4/7, and B12 replacement. Discharge home with prednisone oral, folic acid, cyanocobalamin

heart started quivering/ shaking; jiggling/fluttering/shaking; heart would pound; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on 06Mar2021 13:00 (lot number: EN6205), dose 2 on 27Mar2021 13:00 (Lot Number: ER8730), both via an unspecified route of administration, administered in right arm at the age of 79 years old as single dose for covid-19 immunisation. Medical history included environmental allergies. The patient's concomitant medication received prior vaccinations within 4 weeks included allergy shots. Vaccine was not Administered at Military Facility. No History of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. Caller had a side effect from the Pfizer COVID shot. Her cardiologist suggested she call. She had the first shot 06Mar2021, and two days later on 08Apr2021, her heart started quivering/ shaking only at night. It would wake her up, or would wake her up in the morning when it was time to get up. It never happened during the day. The doctor said it could have just been because she was busy during the day, and didn't notice it. She only noticed it at night. This went on for 2 weeks. After the first week, it was still doing it so she went to her cardiologist. The doctor gave her a heart monitor (Mar2021). She wore the heart monitor for 2 weeks. She just got it off a week this Tuesday, but didn't have results yet. She got the second vaccine. The heart issue got better. It was doing it anymore before the second one. Her heart would pound sometimes too (Mar2021), but not for a long time. It would be less than a minute, and it wouldn't happen every time she had the heart shaking. She could hear it. The jiggling/fluttering/shaking got better before she went for her second shot (Mar2021). She got the second shot on 27Mar2021, and it started up again two days later. For three days now she hasn't been awakened by it. Her heart hasn't been pounding. Her doctor thought she should let Pfizer know. She had never felt better now. She would take her heart rate and blood pressure after each episode, and her blood pressure nor her heart rate ever went up (Mar2021). She never felt bad the whole time. It was just alarming to her when it would happen. She didn't know if it was gone for sure, but it had improved. She noticed it on a Monday the 08Mar2021 two days after the vaccine she got on 06Mar2021. She noticed it both times two days later. The events did not require a visit Emergency Room, but required Physician Office, didn't go first week was doing it regularly went to cardiologist made appt and went. The outcome of the event Heart pounding was recovered on an unspecified date, of the other events was recovering.

Patient is a 79 y.o. female with a history of CAD, COPD, chronic CHF, DM2, HTN who presented to hospital 4/14/2021 with chest pain, upper abdominal pain and ongoing melena. 1. Melena: Ongoing for 6 weeks per patient. Underwent colonoscopy 4/7/21 with polypectomy, no inflammation or bleeding. CT A/P 4/14/21 with mild esophagitis, mild colitis, no other acute finding. IV PPI BID. GI followed, pt is s/p EGD 4/15/21 with normal esophagus, large hiatal hernia with multiple Cameron ulcers and erosive gastropathy with no stigmata of recent bleeding. Biopsied. H&H stable at discharge. Avoid NSAIDs. Discharged on PPI 2. Colitis: Mild on CT A/P. Stool PCR discontinued as diarrhea resolved. Patient is s/p cipro/flagyl in ED. Transitioned to Unasyn with end date 4/15/21. 3. Acute Blood Loss Anemia: Baseline Hgb ~ 12-14. Down to 5.8 on admit in setting of GI bleed. Transfused 1 unit pRBC 4/14/21. Trend H/H Q6H. Transfuse for Hgb < 8 given cardiac diease. Iron studies with evidence of iron deficiency. s/p IV iron. H&H stable at discharge 4. AKI: Baseline creat ~ 0.7-0.8. Elevated to 1.35 in the setting of bleeding/anemia. Held ACEi and diuretic. She did receive IV contrast. Colloid resuscitation with blood transfusion. Resolved 5. Chest Pain w/ Elevated Troponin: Troponin T 16 on admit in setting of severe anemia and poor clearance with AKI. ECG non acute on admit. CT PA negative 4/14/21. Suspect demand ischemia. Negative delta troponin. No further workup. 6. Hx COVID 19: Positive testing 12/2020. Repeat testing ordered in ED 4/14/21 and remains positive. She desaturated only after receiving IV fentanyl in ED. Asymptomatic, CT chest 4/14/21 without GGO. Given > 90 day, patient remain in isolation per OhioHealth Policy. 7. CAD: LHC 9/28 with diffuse disease DES to OM1 and BMS to Circ/OM1. Held ASA/Plavix on admit due to GIB, resumed at discharge. Continued home statin, imdur, BB. 8. Chronic HFrEF: due to ischemic cardiomyopathy. LV 45% on LHC. Continued BB, Imdur. ACEi and Maxzide held initially with GIB and hypotension. PCP follow up 9. HTN: Soft BP on 4/15/21. Continued Imdur and BB with hold parameters. Norvasc, Maxzide, and ACEi discontinued at discharge. Follow up with PCP 10. IDDM2: A1c 7.8% on 3/2021. Continued home regimen. 11. Essential tremor: Follows with Dr. (Neurology). Continued home Propranolol. 12. Pulmonary Nodule: Ct chest 4/14/21 with 6mm pulmonary nodule, repeat in 6-12 moths.

past medical history significant for coronary artery disease s/p PCI, chronic hypoxic respiratory failure on 2L, hypertension, multinodular goiter who presents to ED on 4/25/2021 with symptoms of progressive shortness of breath, dysphagia and neck pain. Labs showed elevated BNP of 3000 and a hemoglobin of 8.5. Patient was incidentally positive for COVID-19 pneumonia

SOB began within 24hrs of receiving second vaccine dose on 03/31/2021. Scheduled appt with PCP for 4/27/2021. Up to that date she continued to experience SOB. Unable to breath in supine position. Had to sleep in chair. Developed 4+ pitting edema in lower extremities. On 4/27/2021 the PCP sent patient to Hospital ER. Patient was admitted to cardiac floor.

patient felt lightheaded and nauseous suddenly on the morning after the 2nd covid vaccine. she tried to lower herself to the floor, but blacked out and hit her head, requiring staples. she is still experiencing extreme fatigue, which is unusual for her. she is highly functional at baseline.

patient developed heart attack several hours after vaccine, developed chest pain, had to come to hospital, had elevation in troponins and was kept overnight, medical management was given

This 79 year old female received the Covid shot on 2/18 and went to the ED on 2/26 and was admitted on 2/26 with chest pain and abdominal pain and again to the ED on 3/14 and admitted on 3/14 with hyperkalemia, acute renal injury, chest pain and died on 05/04/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Lightheaded and dizzy; Nauseous; Dehydrated; Lightheaded and dizzy; Atrial fibrillation with rapid ventricular response; Not feeling well; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 at the age of 79 years old, (Batch/Lot Number: EW0164) as SINGLE DOSE for covid-19 immunisation, and dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 Batch/Lot number was E or F, N6205;) as a single dose, for covid-19 immunisation. Medical history included diabetes from 2009, coronary artery disease from Jan2020, and atrial fibrillation and Shingrix Vaccine/NDC, Lot Number, Expiration Date not known by caller.Vaccination Date: Jul2018. Concomitant medications were not reported. On 17Apr2021, the patient reported not feeling well. 18Apr2021 she woke up in the morning and was lightheaded and dizzy. She was also nauseous.States she called an ambulance. She was found to be in Atrial Fibrillation. she also found out when she got to the Emergency Room that she was dehydrated. States she does not know if that ties in with the vaccine or not. She states someone told her she should be drinking a lot of water since she had the vaccines; asks if this is true. She was admitted to the hospital on Sunday 18Apr2021 and was released yesterday afternoon 20Apr2021.On 19Apr2021, she was lightheaded and dizzy, nauseous. She also experienced atrial fibrillation with rapid ventricular response and was dehydrated. The patient was admitted to the hospital on 18Apr2021 and released on 20Apr2021. The outcome of the events of not feeling well, lightheaded and dizzy, nauseous were recovered on 20Apr2021, the remaining events was unknown. .

The exact dates and information of the vaccine is not available to me. She presented to my care after being admitted to the hospital with altered mental status. She has had cerebral ischemia since her vaccination, e.g. she's had a stroke.

This 79 year old white female received the Pfizer Covid shot on 2/11/21 and went to the ED on 2/24/21 and was admitted on 2/24/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) (CMS/HCC)

SEE LIST FOR LIGHT HEADED , FACE FLUSHED 5/6 DAY OF 5/9 AWOKE 00:45 WITH SHORTNESS OF BREATH, FACE PRICKLY feeling , CHILLS, oxigen sat 99/% lung clear,

This 79 year old female received the Covid shot on 2/19/21 and went to the ED and admitted on 4/22/21 with the following diagnoses listed below. I21.4 - Non-ST elevation (NSTEMI) myocardial infarction

Cerebrovascular accident (CVA) due to stenosis of right middle cerebral artery (HCC) (163.511); Cerebrovascular accident (CVA) due to stenosis of right middle cerebral artery (HCC) (163.511); This is the spontaneous report from a contactable consumer (patient). This 79-year-old, nonpregnant, female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 2 at a hospital facility, via an unspecified route of administration, administered in left arm on 10Feb2021 on 09:00 am (age at vaccination 79 years; batch/lot number: FL9267) as single dose for COVID-19 immunization. Medical history included borderline high blood pressure from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported however patient reported they had medication within 2 weeks of vaccination. The patient previously took penicillin on unspecified date, and received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1, via an unspecified route of administration, administered in right arm on 18Jan2021 at 09:15 AM (age at vaccination 79 years; batch/lot number: EL9261) as single dose for COVID-19 immunization. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination patient had been tested for COVID-19. Patient had a negative nasal swab on 22Feb2021. Patient experienced cerebrovascular accident (CVA) due to stenosis of right middle cerebral artery (HCC; 163.511) on 02Mar2021 at 01:30 which resulted in emergency room/department or urgent care. It was also reported patient had a hospitalization for 2 days. Treatment received was reported as CT and MRI of head & neck, X-ray of chest, "echocar". Patient was recovering from CVA due to stenosis of right middle cerebral artery.

Lightheaded/feeling dizzy; BP 168/68, BP 158/73, BP 152/73; O2 SAT 97%, O2 SAT 96%, O2 SAT 97%; HR 62, HR 68, HR 69; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a 79-year-old non-pregnant female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number: el3302, Expiration date: unknown), via an intramuscular route of administration in left arm on 04Feb2021 at 09:19 at a single dose for covid-19 immunization in clinic (at the age of 79-years). The patient had rash to PCN (penicillin). The patient's medical history included HTN (hypertension) and concomitant medication included lisinopril for an unspecified indication on an unspecified date. The patient did not have any other illness at the time of vaccination and up to one month prior. Patient's vital signs were taken three times. On 04Feb2021 at 09:36, the patient experienced feeling lightheaded, BP (blood pressure) 168/68, BP 158/73, BP 152/73, oxygen saturation 97%, O2 SAT 96%, O2 SAT 97% and HR (heart rate) 62, HR 68, HR 69. Patient given water. After 20 minutes the patient stated feeling dizzy but wanted to leave. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Hypertension; Tachycardia; Extreme flushing to face and neck; glowing red; took her pulse and it was 145; Persistent head to toe macular erythematous Rash; Dull Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered on the left arm on 21Apr2021 13:12 (Batch/Lot number was not reported; Expiration Date: 31Jul2021) as 1st dose, single for covid-19 immunisation. Medical history included fibromyalgia (diagnosed more than 20 years ago), bladder cancer (diagnosed 13 years ago the first time, 8 reoccurrences and has been cancer free for 2 years, cancer free for 2 years), multi drug allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities, diabetes, and obesity. Concomitant medications included lisinopril, levothyroxine, and oxazepam. No vaccines received within 2 weeks. In 12 minutes after the injection on 21Apr2021, while she was still sitting in the parking lot, patient developed tachycardia on and extreme flushing to face and neck on 13:20. They were as red as being in the sun. She was aware of tachycardia first. Then she looked in the mirror and was glowing red. Patient was observing in parking lot and took her pulse and it was 145. Persistent head to toe macular erythematous rash occurred next. They took her to the ER about 20 minutes after the injection. In the ER, she was given 25mg of Benadryl IV and 125 mg of Solumedrol IV. When both of those wore off the next day, the generalized rash came back on Thursday (22Apr2021). The rash was persistent but not as flushed looking as before. When they got her into ER, the first blood pressure reading was 198/117, which was within 20 minutes of injection. Hypertension was experienced on 13:30. Her blood pressure usually was fairly low and was back to normal now. She had one reading of 124/76 to 170/something. Her normal range is anywhere between 150-170/70-80's. She is on Lisinopril. The other morning when it was 124/76, was just a fluke. That was an unusually good reading. They did a regular panel of lab work when she went to the ER. They did not tell her that anything was abnormal. She asked them to run an A1C, but they told her they could not. They did a chest film, EKG, placed IV to give medications, but no fluids given. Her doctor said not to get second dose of the vaccine. She had it at the hospital and they had reports of other people with a rash. The patient considered the events tachycardia, extreme flushing, macular erythematous rash and hypertension were medically significant while for headache was non-serious.; Sender's Comments: The reported events were possibly causally related to the bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), due to plausible temporal relationship. This case will be reassessed should additional information become 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.

Pfizer-BioNTech COVID-19 Vaccine EUA - admitted to hospital 04/5/2021with covid-19 after one dose of Pfizer Covid-19 vaccine on 3/18/2021. 79 yo Female received 1st dose of Pfizer Covid-19 vaccine on 3/28/2021. Reactions reported were body aches and soreness at the injection site shortly after vaccine injection. After vaccination, patient found out that 2 of her family members that she lives with had positive Covid-19 tests (health status of these family members unknown). Patient got a covid-19 test on 3/30/21 and it was positive. On 4/2/2021, pt had a telemedicine visit for fever and dry cough. Azithromycin and albuterol prescriptions were given because of concern

Arrival Date: 2/14/2021 Discharge Date: 2/18/2021 Primary Discharge Diagnosis: Principal Problem: Sepsis (HCC) POA: Yes Active Problems: GERD (gastroesophageal reflux disease) POA: Yes Portal hypertension (HCC) POA: Yes Thrombocytopenia (HCC) POA: Yes Esophageal varices (HCC) POA: Yes Chronic systolic heart failure (HCC) POA: Yes Essential hypertension POA: Yes Hyperlipidemia POA: Yes Operations/Procedures: None Pertinent Diagnostic Studies: Xr Chest 1 View-portable Result Date: 2/15/2021 Portable chest at 0039 hours HISTORY: New left internal jugular catheter. AP sitting portable chest compared to February 14, 2021 and shows introduction of a left internal jugular catheter with the tip doubled back on itself possibly in the distal brachiocephalic vein. No evidence of pneumothorax. There is a coarse appearance to the pulmonary interstitium bilaterally some of which may reflect chronic disease though the possibility of a very small infiltrate at the left base retrocardiac cannot be excluded and has not changed. No significant pleural effusion or definite acute vascular congestion. The heart, mediastinal and hilar structures are not enlarged or changed. Degenerative disease of the spine is noted with a mid thoracic scoliosis convexity to the right. Left internal jugular catheter in place with distal tip curved back on itself possibly in the distal brachiocephalic vein. Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Xr Chest 1 View-portable Result Date: 2/14/2021 PROCEDURE: XR CHEST 1 VIEW-PORTABLE HISTORY: cough COMPARISON: 9/27/2020 Impression: Limited portable view obtained. Heart mediastinum stable There is mild central vascular and interstitial prominence which could reflect developing mild interstitial edema or interstitial pneumonitis. No severe CHF. Some slightly more focal patchy increased interstitial airspace opacity in the left lower lobe retrocardiac region is identified and could represent a developing infectious inflammatory infiltrate. Clinical correlation and follow-up advised Incidental findings: CXR- Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Test Results Pending at Discharge: Pending Labs Order Current Status Microscopic Urinalysis In process Blood Culture Peripheral Preliminary result Blood Culture Peripheral Preliminary result Active Issues Requiring Follow-up: ISSUE- Needs to follow up with PCP Discharge Medications: Discharge Medications New Medications Sig cefpodoxime 200 MG tablet Commonly known as: VANTIN Start taking on: February 19, 2021 Take 1 tablet (200 mg total) by mouth daily. Do not start before February 19, 2021. Quantity: 6 tablet Discharge Disposition: Home Or Self Care Code Status: DNR Details of Hospital Stay History of Present Illness (from the H&P) CHIEF COMPLAINT: Chills fever, nausea, vomiting, diarrhea after receiving Covid vaccine #2 (Pfizer) HPI: This is a 79 y.o. female with a past medical and surgical history as below-most significant for breast cancer that was diagnosed in 2017, portal hypertension secondary to fatty liver in 2019, resultant esophageal varices that bleed presents with the following chronological history: Approximately 9 AM yesterday morning she went to the clinic for her second Covid vaccination. At that time her temperature was 97.3. She felt fine the rest the day. At 1 AM she woke up with shakes. She continued with nausea and that resulted in vomiting and then diarrhea. She also had severe pain in her thighs. This was severe enough that she called the ambulance. Patient also relates later that she had had some burning on urination 2 days prior to the vaccination. She had leftover Macrodantin that she took 9 PM yesterday. Also relates back in December she was seen by Dr for vaginal infection and 2 times a week she has to administer intravaginal antibiotics. She has had multiple GI bleeds secondary to esophageal varices and is followed regularly by Dr who has had to do multiple banding procedures on her. She also relates she has an enlarged spleen and is followed by Dr. In the emergency room she was noted to be febrile and hypotensive. She received a total of 5 L of normal saline in the ER to bring her pressures up with a systolic below 100. She has a very elevated procalcitonin as well as lactic acid. Urine is positive for large amount of blood and small leukocyte esterase Hospital Course 79 y.o. year old female with HTN, infiltrating ductal carcinoma of the right breast stage I status post lumpectomy with positive margins was on anastrozole but taken off secondary to abnormal liver enzyme testing, CLL/thrombocytopenia stage I with no treatment needed, fatty liver complicated by portal hypertension/splenomegaly resulting in bleeding esophageal varices, history of viral cardiomyopathy in 2006, B12 deficiency, history of admission for septic shock, chronic diarhea, presented to the emergency room on 2/14 complaining of fevers, myalgias fatigue nausea and vomiting 24 hours after having a second dose of COVID-19 vaccine. She was admitted for septic work-up and later found to be hypotensive after 7L of fluids and was transferred to the ICU for septic shock, left IJ was placed. Source of infection found to be septic from UTI. Urine culture sterile with less than 1000 colony forming units and blood cultures no growth to date. On the day of discharge. Shock resolved. Her procalcitonin trended down. Wonder whether she had an exaggerated response to the Covid vaccine given that today the urine culture shows no growth. Regarding acute on chronic diarrhea she had unremarkable GI PCR and diarrhea improved after starting Imodium. She is had extensive work-up for this with GI as outpatient and days colonoscopy planned in the near future. CLL with splenomegaly/nodular hyperplasia of the liver with noncirrhotic portal hypertension/neutropenia/thrombocytopenia/hyperbilirubinemia/esophageal varices requiring banding in the past -Was restarted on propanolol and midodrine prior to discharge. -Chronic stable anemia/B12 deficiency-getting supplementation every 3 months Thrombocytopenia -she did have drop in platelet counts during admission while being on pantoprazole and Lovenox and these were discontinued and platelet count stabilized. She can have repeat CBC as outpatient to document improvement in platelet count. She was not noted to have any platelet type bleeding. History of right-sided breast cancer status post lumpectomy was on anastrozole but stopped secondary to liver disease Lab Studies: Lab Results Component Value Date GLUC 86 02/18/2021 CALCIUM 8.4 (L) 02/18/2021 NA 149 (H) 02/18/2021 K 3.8 02/18/2021 CO2 23 02/18/2021 CL 114 (H) 02/18/2021 BUN 18 02/18/2021 CREAT 0.9 02/18/2021 Results from last 7 days Lab Units 02/16/21 0702 MAGNESIUM mg/dL 1.9 Lab Results Component Value Date CALCIUM 8.4 (L) 02/18/2021 PHOS 2.4 (L) 02/17/2021 Results from last 7 days Lab Units 02/18/21 0724 02/14/21 1855 WHITE BLOOD CELL COUNT Thou/uL 4.1 < > 2.9* HEMOGLOBIN g/dL 10.0* < > 8.8* HEMATOCRIT % 30.0* < > 27.7* PLATELET COUNT Thou/uL 33* < > 37* NEUTROS PCT % -- -- 84.7 NEUTROS ABS Thou/uL -- -- 2.40 LYMPHS PCT % -- -- 10.9 LYMPHS ABS Thou/uL -- -- 0.30* MONOS PCT % -- -- 3.1 MONOS ABS Thou/uL -- -- 0.10* EOS PCT % -- -- 0.8 EOS ABS Thou/uL -- -- 0.00 BASOS PCT % -- -- 0.5 BASOS ABS Thou/uL -- -- 0.00 < > = values in this interval not displayed. Lab Results Component Value Date ALT 28 02/18/2021 AST 15 02/18/2021 GGT 22 09/09/2019 ALKPHOS 116 02/18/2021 BILITOT 1.0 02/18/2021 Physical Exam at Discharge Last Vitals: BP 117/70 (BP Location: Left arm, Patient Position: Lying) | Pulse 73 | Temp 98.1 °F (36.7 °C) (Tympanic) | Resp 18 | Ht 1.626 m (5' 4") | Wt 73.2 kg (161 lb 6 oz) | SpO2 94% | BMI 27.70 kg/m² Patient was seen and examined by me on the date of discharge. General Appearance: Alert, Awake, not in acute distress. Cardiovascular: S1-S2 regular, no murmurs present. Respiratory: Bilateral air entry present, no added sounds heard Gastrointestinal: soft, non-tender, non-distended, bowel sounds present. Extremities: B/l LE edema I spoke with the patient regarding the discharge plan. The discharge plan was discussed with the case management and the nursing staff. Patient verbalzied understanding of the discharge and was agreeable for the discharge plan. Called pt;s husband to give update on care plan but got voice mail. Condition on Discharge: Improved

she has a lot of fatigue did not take temp but is colder than usual and wearing sweater which she says she normally doesn't, and if she takes a deep breath it is tight and hurts her chest and does have an occasional cough Contact with and (suspected) exposure to covid-19

10 minutes after the shot was given, her daughter yelled out to us that patient had slumped over momentarily in the chair of the waiting area. We went out to assist her, she was sitting upright with assistance from her daughter when we got out there. As we asked her questions, she was staring blankly at us and not responding to our questions, we called 911. She did not answer us for as least a couple minutes, although there was a pulse and she was breathing. She was sweating profusely. Daughter said she was warm and dizzy right after, also that she has a history of fainting and fear of blood.

deceased alone at home; Constant Complains of severe chest pains after taking the first shot and she was found deceased alone at home clutching a hot water bottle to her chest; This is a spontaneous report from a contactable consumer. A 79-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on Feb2021 (Lot Number: EL8982) as 1ST DOSE, SINGLE for covid-19 immunization. The patient medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. On Feb2021, the patient experienced constant complains of severe chest pains after taking the first shot and she was found deceased alone at home clutching a hot water bottle to her chest. Since the vaccination, the patient has not been tested for COVID-19. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of chest pain was not recovered.; Reported Cause(s) of Death: deceased alone at home

red blood bleeding; gastrointestinal upset; diarrhea; chills; headache; This is a spontaneous report from a contactable consumer(patient). A 79-year-old female patient received first dose of bnt162b2(BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date (at the age of 79-years-old) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that, after the first dose of the vaccine she had side effects that included red blood bleeding during the 3-4 days that she had gastrointestinal upset, diarrhea, chills, and headache. The patient stated, the bleeding stopped, and she was doing better now but she was just upset and concerned with the bleeding. She did not know if she should receive the second dose. She would like to know should she receive the second dose after having this side effect. The Pfizer team responded as the patient should not get the Pfizer-BioNTech COVID-19 Vaccine if patient had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. The Pfizer team referred patient to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. The outcome of the events red blood bleeding was recovering, and the outcome of the events gastrointestinal upset, diarrhea, chills, and headache was unknown. Information on the lot/batch number has been requested. Information on the lot/batch number has been requested.

Headache; Chest tightness; Cough; Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 11:30 (Batch/Lot Number: EL8982) (at the age of 79-year-old) as 1st dose, single for covid-19 immunization. Medical history included latex allergy and A-Fib. Concomitant medication(s) included apixaban (ELIQUIS) and metoprolol (MANUFACTURER UNKNOWN) both taken for an unspecified indication, start and stop date were not reported. 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. On 31Jan2021 08:00, the patient experienced headache, chest tightness, cough and difficulty breathing within 24-36 hours. No treatment was given for the events. The outcome of the events was recovered on an unknown date in 2021. No follow-up attempts are possible. No further information is expected.

Pt's daughter reported on 6/9/21 to pharmacy that pt went into afib 2 days post vaccination on 3/9/21. Afib lasted until 3/25 in hospital. Had 2nd dose on 3/31 with no issues.

Patient present to ED for chest pain and fatigue. Per patient, she was gardening last week and developed chest pressure/SOB when moving around some mulch this lasted on and off for 3 days and then was followed by intense fatigue which persisted today so she came into ED. She was placed in observation for chest pain, and to rule out ischemia. Upon admission, a COVID-19 test was run for screening, and was positive. Other than fatigue and chest pain, she was not endorsing other symptoms and did not have hypoxia or coughing at all. Although on admit, there was plan to get a stress test, given the COVID-19 diagnosis, this was deferred. She was discharged to home in stable condition on 5/5.

CONTINUING PALPITATIONS, SHORTNESS OF BREATH, FATIGUE, AND DIZZINESS.. . JUST ABOUT THE SAME TIME, i HAD A NEW HEART DEVICE IMPLANT. A-FIB SUSEQUENTLY DIAGNOSED. MY CARDIOLOGIST DOES NOT THINK THERE IS A CONNECTION. I WANT TO BRING THIS TO YOUR ATTENTION BECAUSE THERE MAY BE A CHANCE THAT OLDER PERSONS ALREADY PRESENTING WITH CARDIOMYOPATHY MIGHT BE SUSCEPTIBLE TO THESE SYMPTOMS WHILE NOT HAVING THE SAME LEVEL OF INFLAMATION AS IS BEING NOTICED IN YOUNG ADULTS. INDIVIDUALS AT MY AGE TEND TO HAVE SO MANY COMORBIDITIES UNTIL THEY MAY BE UNLIKELY TO NOTICE NEW SYMPTOMS.

Patient had previously been feeling short of breath for about a month. She received the 2nd Pfizer covid vaccine dose on 6/9 and felt nauseous the next two days. She came to the ED on 6/10 with nausea, vomiting, and lethargy. Found to be hypotensive, bradycardic, and in 3rd degree heart block. Suspect patient was already in heart failure and might have developed myocarditis after receiving the vaccine which could have exacerbated her heart failure.

2d dose: Covid19(Pfizer-BioNTech), Lot EL1283given by injection, Left Arm, Feb 3, 2021, 3 PM. Pt walking stamina declined over the next week. Prior to second dose, she could walk about 1.25 miles; afterward her stamina declined to a few blocks distance. On Friday, Feb 12, Pt collapsed after bath. Saturday, Feb 13, 2021, Pt did not get up. Began episodically screaming in pain. Ambulance to Hospital. Admitted and given emergency pericardial window to address pericardial effusion. Pt was discharged Feb 19, 2021, diagnosed with 1:Cardiac tamponade; 2:Hypotension; 3:Sepsis; 4:Acute kidney injury. Slowly Pt recovered some ability to walk but as of June 11, 2021 her distance has not exceeded 0.25 mile.

This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207), intramuscular, administered in the right arm on 16Mar2021 15:00 (at the age of 79 years old) as second dose at a single dose for COVID-19 immunization. Medical history included Essential thrombocythaemia from 2013 and ongoing, ongoing Acid reflux (esophageal) which was diagnosed at least 10 years ago. No other vaccinations was given within four weeks prior to the first administration date of the suspect vaccine. Concomitant medications included hydroxycarbamide (HYDREA) for Essential thrombocythaemia from 2013 and ongoing; ongoing omeprazole (PROTONIX) for Acid reflux (esophageal). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200) intramuscular in the right arm on 23Feb2021 (at the age of 79 years old) for COVID-19 immunization. The patient experienced extreme heart palpitations on 16May2021 23:00. The patient reported that she wanted to call and report an adverse event with the COVID-19 vaccine. When she used the website, it was not working correctly. When she get 95 percent done, it would not accept. She would hit submit and it would not do anything and the email would show up in red. She said that it was the second vaccine. She experienced extreme heart palpitations. She had the vaccine at 3pm and the heart palpitations started that night around 11 and continued for hours. She almost went to the ER. She said that it continued for a good week and into the second week. In the meantime, she had a surgery. She noticed the heart palpitations a little bit then. She said that she is still having it now. She is on medication for it now to try and take care of it and it has only been 3 days though. No further details provided about the surgery. She never had any heart palpitations. She stated that the heart palpitations have subsided and when she has them they are pounding palpitations, but they do not last as long. This was the only thing that happened to her. It was all after the second vaccine. She had no other side effects. Treatment was metoprolol tartrate 25 mg 1/2, twice daily and it has not helped so far. The event required a visit to phyisician office for which they gave her a halter monitor about a month ago on 10May2021. The outcome of the event was recovering.

Emergency hospital visit on 6/22/2021 for high blood sugar and symptomatic. Glucose at bedside point of care was 548 on 6/22/2021 at 2153 and 395 on 6/22/2021 at 2304. During emergency encounter, based on EHR record, sodium chloride 0.9% infusion at 200 mL/hr, Intravenous, CONTINUOUS, Starting on Tue 6/22/21 at 2053 and insulin regular (human) (HumuLIN R) 100 units in sodium chloride 0.9% 100 mL infusion administered at 2153 CDT at 5 Units/hr or 5mL/hr. Impression provided by attending radiology provider, "Mild diffuse interstitial thickening throughout both lungs. Faint interstitial infiltrate at the lung bases, right greater than left. Minimal blunting of the right costophrenic angle. Normal cardiac and mediastinal contours. No pneumothorax. Percutaneous gastrostomy tube in place."

The next day 03/14/2021 I started having soreness and achiness in the morning. About a 3 months later (June) I started having problems with my heart but it wasn't directly after I had my vaccine. . I did see a Doctor about my heart and they put my on a heart monitor and I haven't gotten any results from it yet. I did have a-fib one night. I have appointment with cardio tomorrow 06/25/2021. I thought it was odd because I never had a-fib before and now all of a sudden I do.

felt sick/sick as a dog; feeling nauseous; threw up like crazy; funny feeling around her head/Feeling really funny; face usually gets red when her blood pressure is high and it she is not red at this time; vertigo; blood pressure/ up to 210/110 mmHg; not walking well; funny feeling around her head/Feeling really funny; felt chills/Chills; Felt yucky; her balance was not quite right; felt the really funny feeling going up her throat; Her heart rate has been wanting to be a little higher than usual; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 79-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 30Jan2021(at the age of 79-years-old) (Batch/Lot Number: EL1283) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. Family medical history relevant to AE(s) was none and she is getting close to obesity if she keeps eating like this. The patient previously took first dose of bnt162b2 on 11Jan2021, (Lot Number: EK9231, Expiry Date: Unknown, this is not on the CDC vaccine record card) via Injection administered in Arm Left for covid-19 immunisation and experienced Left arm was real sore after first dose injection. The historical vaccine included shingles vaccine. The patient experienced blood pressure/ up to 210/110 mmHg on 20Feb2021 felt chills/chills on 31Jan2021, felt yucky on 31Jan2021, not walking well on 20Feb2021 , felt sick/sick as a dog on 20Feb2021, feeling nauseous on 20Feb2021, threw up like crazy on 20Feb2021, funny feeling around her head/feeling really funny on 20Feb2021, face usually gets red when her blood pressure is high and it she is not red at this time on 20Feb2021, vertigo on 20Feb2021, felt the really funny feeling going up her throat on an unspecified date in 2021, her heart rate has been wanting to be a little higher than usual on an unspecified date in 2021 and her balance was not quite right on an unspecified date in 2021. The patient underwent lab tests and procedures which included blood pressure measurement: 220/110 mmHg (normal value: 120/80) on 20Feb2021, computerised tomogram: doctor mentioned 3 little places on 20Feb2021, electrocardiogram: unknown results on 20Feb2021, heart rate: little higher than usual on an unspecified date in 2021, laboratory test: unknown results on 20Feb2021. Patient received both dose of the Pfizer covid vaccine on 11Jan2021 and 30Jan2021. On the next day after the 2nd dose, she felt chills. On 20Feb2021, she started not walking well, thought she would fall. All of a sudden, she felt sick and threw up like crazy while she was visiting her daughter for the day. The firefighters came to take her blood pressure and it was up to 210/110 mmHg. They advised her to go to the ER. After several hours, she was given blood pressure and nausea pills. They mentioned vertigo. She says it got okay. However, 2 weeks ago, she started to have a funny feeling around her head. Not dizzy but her face usually gets red when her blood pressure high and she was not red at that time. It was again reported that the day after she was administered the second dose of Pfizer-BioNTech COVID-19 Vaccine she had chills and felt yucky that day. She also reported feeling really funny since 20Feb2021. She was asked for further information on events related to Pfizer-BioNTech COVID-19 Vaccine. She was at her daughter and noticed her balance was not quite right. She started feeling really funny so just lay down there for a little bit. When she did get up after about 15 minutes she started feeling nauseous. She got to the bathroom really fast and threw up like crazy. She did not have her blood pressure cuff with her so her daughter called the fire department and took her down there real fast. At the fire station they took her blood pressure which was 210/110 mmHg, so they suggested she head to the emergency room so she did. She was under observation in the emergency room, but not admitted to the hospital. The doctor mentioned vertigo somewhere along the way before she left the emergency room. She just kind of brushed the vertigo off until she was reading about that the Pfizer-BioNTech COVID-19 Vaccine can cause vertigo. She guesses vertigo was what caused these events because she had been sick as a dog. When they got her on the bed and rolled her back she felt like she was going 90 miles per hour and by the time they got her back on the bed she was throwing up again-but this time and the initial onset of throwing up was the only times she threw up. They gave her something after probably 5-6 hours, blood pressure medicine and nausea medicine and she got ok and left there. Her heart rate has been wanting to be a little higher than usual. About 2 weeks ago she was just sitting on the couch and noticed especially when she would turn her head she still feels really funny; not dizzy, dizzy; she was walking ok; but the really funny feeling keeps hitting her continuously. During call when she sat back down she felt the really funny feeling going up her throat. It was just the weirdest thing, she wishes she had a word to really explain what the really funny feeling was but she does not. She has not checked her blood pressure for a while because she has been holding for a while for this department, so her blood pressure could be up a little bit, but she stated event was worse right now than it has been. Regarding testing/investigations while in the emergency room they did a CT head scan, lab tests, and an EKG. CT head scan results, the doctor mentioned 3 little places but when she talked to her doctor he said that was really just nothing to worry about with age; he said they will check it in 6 months and make sure areas are not growing. Caller has no further information to provide regarding lab tests or EKG results, they did not mention anything. Therapeutic measures were taken as a result of blood pressure/ up to 210/110 mmHg and feeling nauseous. The outcome of the events, felt chills/Chills , Felt yucky, her balance was not quite right, felt sick/sick as a dog, threw up like crazy, face usually gets red when her blood pressure is high and it she is not red at this time, felt the really funny feeling going up her throat, Her heart rate has been wanting to be a little higher than usual was reported as unknown, not walking well, feeling nauseous and vertigo was reported as recovering, funny feeling around her head/Feeling really funny and blood pressure/ up to 210/110 mmHg was reported as not resolved. No follow-up attempts are possible. No further information is expected.

Patient stated that she started to feel dizzy and ever since she had the shot her blood pressure has risen. Before receiving the vaccine she had her blood pressure under control.

Chills, fever, dehydration, intense bone pain, intense fatigue diarrhea, nausea, then pneumonia, then pleural effusion, then extreme hypothyroidism, then multiple episodes of elevated pulse/heartbeat. Over a 2 month period.

On February 18, 2021, three days after receiving the Pfizer vaccine, patient was rushed to the emergency room with rapidly dropping blood pressure and difficulty keeping conscious. After being in COVID isolation for 24 hours, I saw her in a hospital bed and she looked like a corpse. The initial diagnosis was severe Sepsis with liver, kidney and heart problems and blood clots in both lungs. She had never had any of this before getting the Pfizer vaccine. Her WBC count was also very high. She was hospitalized for 10 days and then sent to a rehab facility for 14 days before returning to her independent living facility. She is now taking blood thinners for the blood clots which she didn't have prior to taking the vaccine. He did a miracle in sparing her life!

She thought she might die; Felt a bit strange and wasn't sure what she was feeling.; feeling her heart beating really hard she felt it from her hips, trunk up to breasts/ chest.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 16:30 (Batch/Lot Number: EW0173; Expiration Date: Aug2021) as 0.3 ml, single dose for covid-19 immunisation at the age of 79-year-old. Medical history included ongoing diabetes, ongoing joint injury, She had a need for knee surgery. The patient has never had any vaccines in her life, not the flu shot or measles or anything. There were no concomitant medications. On 06May2021, the patient felt a bit strange and wasn't sure what she was feeling, feeling her heart beating really hard she felt it from her hips, trunk up to breasts/ chest and thought she might die. The events felt a bit strange and wasn't sure what she was feeling, feeling her heart beating really hard she felt it from her hips were recovered on 06May2021, outcome of thought she might die was unknown. The events didn't result in visit to Emergency Room or Physician Office. She received the dose 2 (Lot EW0182, EXP date Aug2021) on 27May2021. The clinical course was reported as: after she received the vaccine she stayed around 30 minutes and seemed ok so she left. She received her shot at 4:30 pm and after she got home she decided she wouldn't know what to do if she had side effects so she decided to lay down on her bed. She states she thought she felt a bit strange and she wasn't sure what she was feeling. After 3 and half hours, while laying on her back, she describes feeling her heart beating really hard she felt it from her hips to the trunk, up to breasts/ chest. Her heart was beating so hard, like thump thump thump, it did not get fast or slow, it was just steady. It was beating so hard that she could feel is shake the bed that she was laying on. The patient stated the doctor has already been informed about her events. She states she didn't call anyone because she thought she might die and she was afraid to move to call. She told herself to just relax, relax, relax so the stress wouldn't bother her. She states the events lasted 3-4 hours but scared to pieces and she was to scared to reach for the phone. she did not go to the doctor about it but told her doctor about it during her check up a couple weeks later and she did routine labs but not for that. She states she is a diabetic. She states she lives alone and is a relatively new widow. The patient stated she has never had any vaccines in her life, not the flu shot or measles or anything. Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.

Pt.'s daughter states after receiving the 2nd Phizer dose 06/09/2021, shortly after 06/11/2021 started experiencing chest pain, went into Cardiac Arrest and Passed away 06/19/2021.

gets hot and then cold and sweating; gets hot and then cold and sweating; gets hot and then cold and sweating; She states the nausea was slight after the first dose but more so after second shot.; headache; not feeling well; no energy; She states after the second shot, her tiredness is worse; She stated after the second shot, her tiredness was worse; Blood pressure high; Fever; Nose bleeds; Severe Chest Pain, fluttering feeling, feels little things; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 13Mar2021 at 10:15 (at the age of 79-year-old) as dose 2, single for COVID-19 immunisation at "PRIVACY" where doctor offices older buildings are. "PRIVACY" now has brand new office, old used for shot and doctors. Medical history included diverticulitis from 2016 and ongoing (she changed her diet. No greasy, no fried, no spicy foods. 2017 attack, 2018 or 2019. Stated that she has felt fine ever since), booster from an unknown date and unknown if ongoing (She stated about 5-6 years ago, she had boosters from childhood shots, every booster. Never had the shingles shot. She stated she has never had a reaction from any of it). Historical vaccine included A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in left arm on 19Feb2021 (at the age of 79-year-old) as dose 1, single for COVID-19 immunisation at "PRIVACY" where her doctor was located, her office was upstairs (the nurses had people spaced downstairs) and experienced a lot of face redness, severe chills, nausea. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that she stated that about a week before the second vaccine she was not sleeping well but she had started to feel better but then she got the second dose and that was a whammy. She stated that when she got the first shot, it kept her awake, like she drank 20 cups of coffee, but after 24 hours, she was just exhausted. She has always been energetic and none of that anymore. She stated after the second shot, her tiredness was worse. She gets exhausted doing nothing. She stated that it was on and off nausea where some mornings felt ok, others she felt nauseated. She does not know if it was the blood pressure pill or not, she was not used to taking any meds. She would probably call the doctor "today" and tell them. She was not used to not feeling well. The patient stated that on 17Mar2021, she got a nosebleed, but she was able to control it and had fever. She called her doctor and told her about the chest pain and nosebleed. She stated the nausea was slight after the first dose but more so after second shot. She was more aware of not wanting to eat and feeling nauseous. She was being cautious because it was so profuse on "Sunday" 21Mar2021 and her blood pressure was so high. "Now", she was on a blood pressure pill and she hopes she does not have another nosebleed. She stated that it was a fluttering feeling, and she can feel little things. It was started testing her blood pressure when it went up on the 17Mar2021. It was 122 and 131. Then on 20Mar2021, it was 174/77 in the "evening" and on 21Mar2021, it really shot up and she went to the hospital and there it was 197/93. She stated that on the 17Mar2021, she was not feeling well and on 18Mar2021, she called her doctor and they told her to stay hydrated and take her blood pressure. She stated then on 21Mar2021, it got really bad. She stated with the medication since the 21Mar2021 "Sunday". On 22Mar2021, it was 156/91 and 128. It was 107/64 "yesterday" and "now" 117/75. She stated that it seems to be back down where it usually has been, more towards lower rather than the higher reading. She has never experienced high blood pressure. She stated that the ER (emergency room) doctor said her problem was high blood pressure and you have had for years but she states she has not. She stated in 2016, she went to the hospital for a diverticulitis attack and then it went back low again at doctor office. In 2017, she went to the ER (emergency room) with diverticulitis. She stated the ER (emergency room) doctor was looking at the blood pressures from times when she was in the ER (emergency room) in 2016, 2017, and 2018 or 2019. She stated that after the ER (emergency room), she always maintained her blood pressure, but he put her on a blood pressure pill, but she was questioning it because she has always maintained low BP. She has never had high blood pressure in her life, it always runs low. On 21Mar2021, emergency room doctor said her blood work for her age looks very good and she really was very healthy. She was thinking, then why was she there. Stated her blood work looked very good and she looked very healthy. The patient was received the treatment in ER (emergency room), Amlodipine, talked to nurse yesterday afternoon and she asked how she was feeling, not like feeling bad, no energy. They gave it to her IV (intravenous) to bring her blood pressure down on "Sunday" (21Mar2021). " Physician office: Followed Up with Phone Calls, 06Apr2021 she has a follow-up appointment ". The patient underwent lab tests and procedures which included blood pressure: 174/77 (unknown units) on 20Mar2021, 197/93 (unknown units) on 21Mar2021, 156/91 (unknown units) on 22Mar2021, 107/64 (unknown units) on 23Mar2021, 117/75 (unknown units) on 24Mar2021. The outcome of fever was resolved on 17Mar2021, nose bleeds was resolved on 21Mar2021; Severe Chest Pain, fluttering feeling, feels little things, Blood pressure high, her tiredness worse, Nausea aggravated was not resolved; gets hot and then cold and sweating, headache, not feeling well, no energy, was unknown No follow-up attempts are possible. No further information is expected.

Pt. states that after receiving the 2nd dose of Phizer 03/30/2021, started experiencing symptoms 04/12/2021 liver enzymes have gone up along with blood pressure reading. Rash appearing all around the thighs and legs with swelling, continuing to appear throughout the body. 04/13/2021 Primary visit, 06/14/021 Primary visit with Prednisone prescribed, and 07/20/2021 Primary continuing the previous prescription.

Tachycardia; This is a spontaneous report from a non-contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 16Jan2021 (at age of 79-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included melanoma, high blood pressure, 2 Bad heart valves, aortic insufficiency, pancreatitis, brain tumor, stage 1 Bronchioloalveolar carcinoma/ stage 4 Bronchioloalveolar carcinoma, metastasis into both lungs, atrial fibrillation, hysterectomy, high triglycerides, thyroid obliterated, irregular heart beat, appendix removed, lung cancer surgery, benign meningioma surgery. Concomitant medication included erlotinib hydrochloride (TARCEVA) taken for an unspecified indication, start and stop date were not reported. The patient previously took synthroid and experienced drug hypersensitivity. The patient experienced tachycardia on an unspecified date. The outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient presented herself to LPN slurring words and 'not herself'. Upon evaluation, patient denied drinking alcohol, knew she was not able to speak correctly and visibly frustrated . With great difficulty she was able to communicate that she had a headache and was slightly dizzy. Failed FAST and does have a history of CVAs. EMS called and patient was taken to ER where they admitted her for observation post Stroke. Per the hosp nurse, patient received tPA treatment and will be moved to step-down unit when a bed is available.

My heart went into Atrial Fibrillation. I take Flecainaide when that happens, I took 100 mg. and 50 mg. one and one-half hours later. Episode lasted 2 1/2 hours. I had no other reason for episode. Usually get a-fib from food allergies.

On Saturday, 1/16/2021, Patient went to the grocery store. Upon her return, she indicated she was experiencing N/V and some throat swelling. Patient subsequently collapsed and expired before she could be brought to an emergency room. During investigation by Coroners Office, it has been reported that Patient may have gotten some takeout food while she was out. Labs are pending and the Coroners investigation is ongoing. Spouse believes that her death was caused by the vaccine.

Pt. left POD after receiving vaccine and waiting allotted 15 minutes. Pt. then returned to POD clinic because was feeling flushed. Pt. also c/o headache. Pt. was noted to be very shaky and have elevated blood pressure upon assessment. BP: 198/92, rechecked 179/82, RR: 16, O2 sats: 98%. Assessed by local EMS. Pt. plans to follow up with PCP.

Pfizer-BioTech COVID-19 Vaccine EUA Witihin 5 minutes, burning chest pain. Within less than 20 minutes BP measured at 203/185 and 15 minutes later 191/187. (normal for me is 128/65). Heart rate 130 (normal is 92) Lightheadedness. EMTs on site did EKG and subsequent BP checks. Recommended Emergency Room care, which I did. Aspirin given, blood work done (at 3 different times). 2 Additional EKGs done with no abnormalities noted.. BP and heart rate went down in approximately 2 hours, to 138/85 and 105, but not to normal status. Have been normalized since.

Patient observed slumping over in chair. When assessed she stated she felt lightheaded and was diaphoretic. Blood pressure obtained at 1400, BP 63/34, HR 84. EMS contacted and dispatched. Patient experienced syncope. 1405 EPI administered per protocol. 1414 vital signs as follows: BP, 168/135; HR 60.

Cardiac arrest on 1/24/21 in the early morning hours then passed away on 1/25/21 around 1:51am in the hospital

Patient began shaking, had shortness of Breath, Increased heart rate 148, low o2 sat 90 increased temp 99.5 respirations were 38 B/P 144/70 blood sugar 198

Patient came back from cardiology appointment (at 2pm) unresponsive. It was reported that she had vomited while at the appointment. She was confused when she could be aroused, stating that she does not have a name.

Dizziness, lightheadedness, sweating, diaphoretic. Patient is diabetic, had high BP, dizziness, loss of hearing, tunnel vision, emotional/crying. Patient was given juice, observation done, vital signs monitored, glucose checked, pulse ox checked. Patient improved after interventions. Patient verbalized feeling better and was discharged to home/self care with husband @ 1:15PM.

Within 15-minutes of vaccination, the patient reported dizziness and a heartburn sensation in her chest. EMS noted orthostatic hypotension in the field, systolic was in the 130s when sitting with a rapid drop to the 70s upon standing. Patient was transported to emergency department. In the ED, the patient reported having a dry mouth and having not eaten breakfast. Patient was administered IV fluids and noted improvement. Labs were unremarkable. Diagnosed with orthostatic hypotension secondary to dehydration, vasovagal episode, and GERD.

The night after receiving dose 1 of the vaccine, she didn't want to eat dinner, was starting to spit up saliva, and noted a new headache, and asked her daughter to sleep with her that night considering she was feeling poorly. She was restless all night, and then at ~5am her L arm began to twitch; she was still alert at this time but didn't realize her arm was moving. Shortly after this she lost consciousness, her eyes rolled back in her head, and she developed a frank GTC seizure. Her daughter called an ambulance, and by the time she was on the way to the hospital, she was awake and alert again. At the hospital, she was initially talking and able to answer most questions appropriately. She was noted to be afebrile, hemodynamically stable, without an O2 requirement, though with tachycardia to the 110s. She was found to have a leukocytosis to ~16, thrombocytosis to ~550, and LDH elevated in the 600s. Over the following day, her mental status declined and she became agitated and disoriented to place/time. CT chest revealed b/l multifocal pneumonia, for which she was started on pip-tazo. She underwent MRI brain (DWI sequence only) which did not reveal any obvious CVA. LP was performed on 1/29 at ~10PM; as far as we can tell, she had only received pip-tazo for antibiotics at this point. CSF studies revealed 220 WBCs (14% PMNs, 76% lymphs, 10% monos), 14 RBCs, Glu 59, Prot 145; GS 2+ WBCs, no orgs; india ink stain negative; Cx pending at time of transfer. Given concern for bacterial or viral meningoencephalitis she was transitioned to vancomycin/ceftriaxone/acyclovir. Patient was then transferred to another Hospital for further management. Micro was all negative or pending at the time of transfer. Shortly after admission to hospital she was intubated. Spine MRI was notable for longitudinally extensive transverse myelitis. All infectious workup has been negative with just two more pending studies for tuberculosis; autoantibody panel pending. She is now able to follow commands with eyes and mouth, but has not been able to move her arms or legs. We do not have high suspicion that this syndrome is related to the vaccine, given that progressive neurological symptoms started the week before vaccine, but thought it prudent to report given the time course.

After 2 weeks of received 1st dose COVID19 vaccine the patient presented to the hospital with a chief complaint of slurred speech, diffuse rash and headache. Found to have diffuse petechiae. Platelet count was < 2. CT head was significant for bifrontal and parafalcine subdural hematoma and scattered subarachnoid hemorrhage. Assessed by the hematology team who stated presentation and lab work was consistent with immune thrombocytopenia. Patient now admitted to the ICU undergoing platelet transfusions and treatment with steroids and IVIG

chest pain, diaphoresis, incontinence, N/V, dizziness; symptoms are no longer occuring after be treated and released from hospital 2/3/21

Patient had episode of intense right eye pain as well as hypertension 170'2/110's with no previous history of HTN.

I had severe chills from early morning until about 5:00 pm. I did not feel good on Sunday, so I ate very little that day and my sugar was about 42 points higher than normal. On Monday, I had the same breakfast and lunch that I normally have -- no changes in routine and my sugar had jumped 60 points when checked just prior to dinner. Today it is still abnormally high (30 points higher), even when checked first thing in the morning. Since my sugar is pretty stable, if I watch what I eat this is extremly unusual. and occurred after the second vaccine shot. I believe the sugar readings are decreasing steadily and will see how they are today and tomorrow.

Patient was vaccinated at 1435 pm and immediately upon vaccination patient noted hives going up her left forearm. This was the same arm of the vaccination. 50mg of Benadryl was administered orally at 1440 pm per our policy and procedures and patient continued to be monitored for adverse signs and symptoms. At 1505 RN noticed flushed face and redness on neck. No shortness of breath was noted and speech was maintained. At 311 patient stated general feeling of racing heart. Vitals were taken. HR 80, BP 140/80, RR 14. EMT was notified and called with a 1526 Arrival. Patient was transferred to Healthcare and call back at 1629 letting us know patient was stable.

This person received the 1st dose COVID-19 vaccine Pfizer @ 08:13am. Then @0930 am, c/o "feeling something on top of her chest, heaviness of chest", sweaty hands, clammy, chest pain. Rapid Response Team called at 09:35 am. Transferred to Emergency Room. In ED: Diagnosis included but not limited to STEMI, NSTEMI, unstable angina, anxiety. At 10:04am- based on EKG, code STEMI was called. Consultation with cardiologist. Then the patient was sent emergently to Cath Lab. The patient was admitted to ICU, intensive care, following Cath Lab

To ED 1/28/2021- 17:06 complaints of racing heart, and increased blood pressure. ED - B/P 200/107- very anxious. Administered 0.1mg oral Clonidine and B/P significantly improved - at discharge B/P 177/76.

ALLERGY REVIEW OF SYSTEMS: Patient denies fever, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath, rash, hives, itching of skin, abdominal pain, muscle aches, dizziness and headaches Pt sent a picture of herself to her son after getting her vaccine. Noted her R eye drooping. : Previous Reactions: none Objective Vitals Vitals: 02/16/21 1535 02/16/21 1545 02/16/21 1555 BP: (!) 185/77 (!) 162/80 (!) 160/63 Pulse: 68 Resp: 16 SpO2: 98% Physical Exam Vitals and nursing note reviewed. Constitutional: General: She is not in acute distress. Appearance: She is not ill-appearing, toxic-appearing or diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: General: Lids are normal. Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Comments: Pt showed this provider picture she took of her R eye drooping. Picture demonstrates slight decrease in eye opening in comparison to L eye. Currently no eye drooping is noted. Cardiovascular: Rate and Rhythm: Normal rate. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Musculoskeletal: Right lower leg: No edema. Left lower leg: No edema. Skin: General: Skin is warm. Coloration: Skin is not pale. Findings: No erythema. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No cranial nerve deficit or facial asymmetry. Sensory: Sensation is intact. No sensory deficit. Motor: No weakness, tremor, abnormal muscle tone or pronator drift. Coordination: Coordination is intact. Coordination normal. Gait: Gait (steady gait with walker) normal. Comments: Equal movement and strength +5/5 to upper and lower extremities. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Comments: Slightly anxious affect. Assessment/Plan Treatment included: no therapy and reassurance Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Pt to follow up with pcp/new pcp if her bp at home continues to be elevated >140/90. We discussed reasons to go to ED. She is stable today and is feeling good. She declined a wheelchair out to the front. She was wanting to walk with her walker. This provider walked out with her and her husband out to the front where they were met by their son. Pt did well on her ambulation without stopping. Pt and husband both voiced appreciation. APRN Electronically Signed 2/16/2021 3:54 PM

80 y/o F presents for tingling sensation to B/L hands and high blood pressure after receiving the 2nd dose of the Covid-19. Patient was taken to the ED for monitoring; she denied any allergic reaction, CP, fever, chills, lightheadedness, dizziness, N/V/D/C, abdominal pain or other symptoms aside from tingling of all fingers. Her blood pressure was 197/92 at the time. EKG was performed, which was normal. No medications were administered. After 2 hours, the blood pressure normalized to 140/80 and patient was discharged.

RECEIVED 1ST PFIZER COVID19 DOSE ON 02/10/21. ON 02/21/21 REPORTED TO ER COMPLAINING OF SHORTNESS OF BREATH(HX OF AFIB AND DUE TO HAVE CARDIOVERSION SOON). DIAGNOSED WITH ACUTE ON CHRONIC CONGESTIVE HEART FAILURE, ELEVATED TROPONIN, ELEVATED BNP LEVEL, AND LOWER EXTREMEITY EDEMA. ON 02/21/21 ADMITTED AS INPATINET IN HOSPITAL.

Patient is a 80-year-old female past medical history dementia, carotid artery stenosis, hypertension, GERD, anxiety/depression, etc. Patient presents to the emergency room with her husband secondary to muscle loss in the area where she received a Covid vaccine on 1/29/2021. Husband states that she had equal and normal symmetrical shoulders. On 29 January she did have her first Covid vaccine injection the left shoulder. Has been noticed that the muscle in the area started to reduce significantly almost where there is a hole/defect. Patient denies any pain or discomfort. There was no report of significant bruising over the area. No redness or fevers. Husband states that he is also noticed patient having bruising bilateral forearms intermittently over the past few weeks. No other complaint. No modifying features. * note physician note from ED visit says vaccinated on 1/29, but her appointment was on 1/28.

Pfizer-BioNTech COVID-19 Vaccine EUA: five days after vaccination patient presented to emergency department with left-sided facial droop, right gaze preference, and left hemi-paresis. Patient diagnosed with right middle cerebral artery occlusion, likely thrombotic etiology, admitted to hospital, and underwent thrombectomy and recanalization with symptom improvement. Discharged to home improved, stable, with vital signs within normal ranges two days after arrival to emergency department.

Vaccine administered on 2/11/21. Presented to emergency department on 2/18/21 following an episode of syncope and collapse at home. Patient reports becoming dizzy and diaphoretic at home and passed out in bathroom. Presented with left-side rib pain and headache attributed to hitting door and ground during fall. Was checked for COVID19 prior to transferring to observation unit and was found to be positive. Patient was discharged home in stable condition from observation on 2/19/21.

On 2/2 received 1 st dose of vaccine. On 2/14 developed nausea, vomiting and diarrhea. Admitted to hospital and found to have a troponin of 72 and coronary angiogram done. Endomyocardial biopsy revealed myocyte damage and mixed inflammatory infiltrate concerning for myocarditis. Patient ultimately has started to recover with treatment of methylpred 1 gram x 3 days.

Chills, vomiting, worsening confusion. Patient had vomiting that began about 48 hours after vaccine dose. Had subsequent chills. No fever. Evaluated by her primary care provider on 2/26 AM and the ER at Hospital on 2/26 PM. Noted to have chills, nausea and vomiting in the ER. Also noted to have tachycardia, likely related to her atrial fibrillation. She had been unable to take her home medications due to vomiting and had missed her rate controlling medications. She was given IV Zofran and Tylenol with good control of her chills and vomiting.

On the second day after i received the first dose of the Covid vaccine I started having tightness in my chest with a cough. On a scale of 1-10 the symtoms were 7-8 I also developed a rash on my arms as if I had been burned. I had to use an inhaler that I already had and I ussed Hydocortisone cream on the rash I saw the Nurse Practicioner on 2/10 2021 and was given Medrol 4mg tabs Today I am still coughing with slight tightness in my chest and the ras is resolving but scars linger.

Patient had her second COVID vaccine on 2/20/21. The next day she developed diffuse body aches. She went on to develop worsening dyspnea and fever to 103°F on February 23. She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed. She therefore presented to the ER on 2/25/21. See full history below from infectious disease note on 3/1/21: Patient is an 80 year old female who has a past medical history notable for hypertension, dyslipidemia, and hypothyroidism. The patient was diagnosed with a high-grade lymphoma of the retroperitoneum in 2004 and completed 4 cycles of multi-chemotherapy (Cytoxan, Adriamycin, vincristine, methotrexate, and IT chemotherapy (Magrath-like regimen)). She completed 4 cycles with complete remission on PET scan. The biopsy of a left cervical lymph node in 2007 revealed follicular lymphoma and she completed radiation therapy to the neck with complete remission. A left axillary lymph node biopsy in 2016 revealed grade-3 follicular lymphoma with mixed follicular and diffuse histology. Chemotherapy was pursued. The biopsy of a pelvic lymph node in 2019 was consistent with G1-2 follicular lymphoma.  She completed radiation to the pelvis in May of 2019.  She developed progressive pelvic adenopathy in April of 2020 and received 5 cycles of chemotherapy. Subsequent CT showed improvement in the adenopathy.  Her course was complicated by pulmonary emboli (September 2020).  In November of 2020 she was started on maintenance Rituxan every 2 months.  She received the 2-dose Pfizer COVID vaccine series on 1/29/21 and 2/20/21. With the above background, the patient presented to the emergency room on February 25, 2021 with complaints of diffuse body aches, which had developed that day after receiving her second dose of COVID-19 (SARS-CoV-2) vaccine.  She went on to develop worsening dyspnea and fever to 103°F on February 23.  She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed.  She called Oncology on February 20 and it was recommended that she go to the emergency room for evaluation.   She was afebrile on presentation to the emergency room.  She was tachycardic, however, with a pulse rate of 117 bpm.  She was breathing at 48 breaths per minute.  Blood pressure was 105/80 mmHg.  Oxygen saturation by pulse oximetry was 96%. Examination was notable for paraspinous muscle tenderness, tachypnea, mild respiratory distress, and a mildly distended abdomen.  Mild erythematous patches of the feet and forearm were noted, as well as evidence of edema of the right leg from the knee to the lower leg. The peripheral blood leukocyte count measured 0.8x10e3/µL.  ANC was 0.48x10e3/µL.  Platelets measured 96x10e3/µL.  Creatinine was 0.97 mg/dL.  AST was 86 and ALT 20 U/L. The lactic acid level of the venous blood was 3.6 mmol/L. The procalcitonin level of the blood measured 28.37 ng/mL. The C-reactive protein level was 313.7 mg/deciliter. The creatine kinase (CK) level was 4023 U/L.  LDH measured 314 U/L. Troponin was 3.22 ng/mL.  Urinalysis showed 6-10 wbc?s, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, hyaline and granular casts as well as amorphus crystals. A chest radiograph showed possible, but not definite, mild atelectasis or infiltrate at the left lung base.  A radiograph of the right tibia/fibula showed circumferential soft tissue edema seen within the knee and upper to mid aspect of the lower leg.  EKG showed sinus tachycardia but no evidence of arrhythmia or ischemia. Cultures of specimens of the blood were obtained.  The patient was started empirically on vancomycin and cefepime and was admitted.   Faint erythema and ecchymosis of the right leg extending to the dorsal right foot and right wrist erythema were noted following the patient?s admission.  Her condition subsequently destabilized with increased respiratory rate, worsening pain, and hypotension, so she was transferred to the ICU. An abdominopelvic CT on February 25 revealed a small amount of free fluid in the abdomen around the liver, cholelithiasis with no evidence of acute cholecystitis or biliary dilatation, a nonobstructing 5-mm stone of the mid pole of the left kidney, coronary artery calcifications, mild infiltration of the fat in the inferior retroperitoneum and along the right common iliac region with small nodes in this region, similar compared with September 24, 2020, but improved compared with April 30, 2020, and consistent with response of lymphoma to chemotherapy; a myomatous uterus. A CT scan of the right lower extremity showed extensive edema about the subcutaneous tissues of the right lower leg and infiltration of the fat about the muscles of the right lower leg, likely representing cellulitis and fasciitis, and possible myositis. However, there was no air within the subcutaneous tissues or muscles to suggest necrotizing fasciitis and no evidence of abscess.     The patient?s antibiotic treatment was later changed to vancomycin, piperacillin-tazobactam and clindamycin. Cultures of specimens of the blood were later reported as being positive for methicillin-susceptible Staphylococcus aureus on 2/2 sets. Repeat blood cultures (February 26) were positive as well. Her antibiotics were modified to cefazolin monotherapy. Repeat blood cultures on Feb 27 and 28 were negative.   TTE completed 2/27/21 without obvious vegetation.   TODAY (3/1/21): Cultures negative 2/27 and 2/28. Remains on IVIG. Afebrile. She complaints of continued pain in the Right leg and swelling at that left arm. Exam GENERAL: NAD EYES: Sclera and conjunctiva clear NECK: no adenopathy LUNGS: Breath sounds normal and symmetric. No rales or wheezes. HEART: regular rhythm, no murmur appreciated ABDOMEN: Soft without mass, tenderness, organomegaly or hernia. EXTREMITIES: RLE with ecchymosis, slight overlying erythema and anterior blister: blistering more pronounced today. left foot with plantar erythema, some tenderness today. LUE fullness with some heat/tenderness SKIN: No other rashes or other abnormalities are noted. NEUROLOGICAL: alert, appropriate Assessment 1. MSSA septicemia with shock. Positive blood cultures 2/25 and 2/26 thus far. Negative since 2/27. 2. Multifocal cellulitis and interstitial infective myositis of LE- suspect related to above. CT scan was negative for apparent necrotizing infection. 3. Elevated CK due to above- improving 4. Recurrent lymphoma- has been on maintenance rituximab (11/2020). Immunocompromised state. 5. Low immunoglobulins- remains on IVIG 6. Positive urine cultures with Staph aureus- this is typically secondary seeding from bacteremia rather than primary staph uti. CT abd/pelvis negative for nidus of infection along GU track (no renal abscess for example) 7. LUE swelling/tenderness.   Plan 1. Cont Cefazolin without change: goal dosing 8gm/24hr 2. Following repeat blood cultures, negative thus far (tentative D0= 2/27/21) 3. Pending course, anticipate likely TEE--- > presently precluded due to thrombocytopenia 4. Will obtained LUE doppler for completeness given pain/swelling here. Down the line, may need to consider additional imaging (CT?) if concern for abscess, etc). 5. ID will follow along with you. Please call if any questions/concerns. Patient is still admitted, and is in the ICU.

pt reports feeling "unwell" and racing heart No CP No SOB no itching or rash. BP 165/98 P-70 REgular o2 98% pt. reports didn't take BP meds this am. feeling better during obs. D/C home advised to follow up with pcp for BP monitoring

Pt received vaccine and waited appropriate post-vaccination observation period. Pt exited COVID Vaccine Clinic. Returned to clinic at 1535 and c/o of warm sensation in body. Vital signs checked: 209/79, HR 79; Recheck: 201/84, HR 74 Emergency Response team called to transport Pt for evaluation of symptomatic hypertension Pt transported to Emergency Department

38 hours after vaccine was given, patient awoke to a heart attack...says it felt like someone punched her between the shoulder blades and kept their fist there, pain then radiated down both arms to the elbows - more substantial on the rt side, pain also radiated up to the back of her jaw.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department with increasing shortness of breath, fever, and cough one day after receiving second vaccine dose. Patient has been experiencing these symptoms for a month prior to arriving at the emrgency department but worsened just prior to arrival. Vital signs: blood pressure 136/75 mmHg, pulse: 96 beats per minute, temperature 36.5 degrees Celsius, respiratory rate 26 breaths per minute, and oxygen saturation 84% on room air (97% on three liters of oxygen via nasal cannula). Physical exam notable for chills, fatigue, fever, cough, dyspnea, nausea, urinary frequency and urgency, headaches, rales, and an irregularly irregular heart rhythm. Patient diagnosed with pneumonia, anemia, gastrointestinal bleeding, and urinary tract infection, administered intravenous fluids and antibiotics, and admitted to another hospital for further care.

Pt got the first vaccine on 3/1/21 and she developed a heart flutter on 3/4/21 and a rash on 3/5/21. The patient developed heart flutter at night on 3/4/21, which she thought was a heart attack. She called EMS and they checked her out and all her vitals were normal. She saw her MD on 3/5/21 who said it was not a heart attack and she was fine. He did not think the symptoms were related to the vaccination and he thought the heart flutter was stress related. The heart flutter went away on it's own. She also developed a red rash all over her body the evening of 3/5/21 that is still present. She has been treating that with Vaseline intensive care and Aloe. Her skin is very dry and crepey

severe thrombocytopenia, mucosa bleeding causing hemoptysis, cutaneous ecchymosis treated with IVIg, pulse steroids, and platelet transfusion.

On the 5th day after receiving the vaccine I became dizzy. The next morning I became very dizzy and went to the hospital. They admitted me to Emergency because my blood pressure was extremely high-they said later it was about 187/ ?. While I was there the blood pressure went up over 200 to 214/81. I was dizzy and nausious and shaking because I became very cold even though the nurse covered me with 3 blankets. After I left the hospital it took until after I got a prescription for meclizine filled and took one at 7PM before I was able to get the blood pressure down to a normal range - 130/64. Today I am still taking meclizine as prescribed and am still slightly dizzy. I do not know if this was related to the vaccine or not.

Received vaccine at local health department clinic on 02/18/2021-presents to this reporters facility ED on 02/23 with worsening shortness of breath x 24 hours. patient currently off warfarin for afib x 72 hours due to upcoming outpatient scheduled carpal tunnel surgery 2/25. afib with RVR in ED. Afib treated in ED, anticoagulation therapy resumed, surgery delayed

pt CC of light headed took pt's vitals to find pt HTN. BSL was 111. Pt refused transport to ED. Advised pt of rights and risks of refusal. Pt signed refusal. Advised pt to seek help if symptoms worsen EOR.

Very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days; Diarrhea; Vomiting day 4 to day 6; Continuing nausea; Continuing nausea with loss of 5 lbs; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EM9810), via an unspecified route of administration, right arm on 14Feb2021 12:15 PM at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient wasn't pregnant at the time of vaccination. The patient's medical history included Allergies to medications, food, or other products included Sulfa, gluten and cortisone meds, diabetes since age 5 and heart failure. List of any other medications the patient received within 2 weeks of vaccination included Thyroid, metoprolol succinate (TOPROL XL), KCL, furosemide (LASIX [FUROSEMIDE]) (reported as Lasux), spironolactone. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days on 17Feb2021 12:00 PM, diarrhea and vomiting day 4 to day 6 and now continuing nausea with loss of 5 lbs because of nausea at day 11 on Feb2021. The patient received additional insulin as a treatment and call to cardiac physician. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the event Blood glucose increased, Diarrhea, Vomiting, Weight loss was recovering and outcome of event Nausea was not recovered. Information regarding lot/batch number has been requested.

bleeding from ileostomy; abdominal pain; This is a spontaneous report from a non-contactable pharmacist. An 80-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), intramuscular on 28Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Iodine, Levaquin and Morphine and experienced allergies. It was unknown if the patient received other vaccines in four weeks. The patient experienced abdominal pain and bleeding from ileostomy on 01Mar2021 at 11:00PM. The events resulted in emergency room/department or urgent care and hospitalization. The patient had no COVID prior vaccination and had not tested post vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Based on the information available the events abdominal pain and bleeding from ileostomy are attributed to intercurrent medical conditions that were not related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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.

Multiple strokes resulting from blood clots starting 10 days past 2nd shot. Fuzzy headed with headache prior to strokes.

choking experience; throat tickled; dizziness; bowel movements all afternoon which is a common allergic reaction; bowel movements all afternoon which is a common allergic reaction; Her heart started to pound/a rapid heartbeat; her ears started to ring (a pounding in her ears); had pressure in her jaw, chest, head, ears, and allover; high adrenal stimulance; excreted 1 cup of urine more than what she usually does; high pressure; dehydrated; couldn't sleep; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 01Mar2021 13:30 (at 80 years old) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome, allergic to gluten, lecithin, and other barky parts of plants, high pressure, she did not hear very well, left breast surgery, skin cancer. She had a small skin cancer taken off each of her legs, one removed in Jan2020 and one removed in Feb2020. They are all healed up and they are fine, it was not the bad kind. There were no concomitant medications. The patient experienced choking experience in which her throat tickled, and dizziness, dehydrated, her heart started to pound (a rapid heartbeat), her ears started to ring (a pounding in her ears), she had pressure in her jaw, chest, head, ears, and allover, she had high pressure, excreted 1 cup of urine more than what she usually does, couldn't sleep due to high adrenal stimulance, bowel movements all afternoon which is a common allergic reaction all on 01Mar2021 with outcome of unknown. Clinical course was reported as follows. She mentioned that she was fine for 20-30 minutes to an hour after she got home. That afternoon, she noticed that her bowel movement was regular, constant, and repeating which was not normal and would typically indicate SIBO (Small intestine bowel overflow) in which the colon empties everything. She mentioned that this was indicative of her gluten allergy. She reported having had bowel movements all afternoon which is a common allergic reaction she has to plants like lectin and gluten especially due to the irritable bowel system-her whole bowel system will empty and she will have to replace 2 days worth of food. With this event starting 01Mar2021 her bowels just kept emptying and emptying. During dinner while she was eating and watching tv, her heart started to pound (a rapid heartbeat), her ears started to ring (a pounding in her ears), she had pressure in her jaw, chest, head, ears, and allover, she had high pressure, and a choking episode in which her throat tickled, and dizziness that she couldn't get up. She took hot water for the tickling sensation and took one aspirin for the other symptoms, but she still did not feel very well. She went to bed at 9pm but couldn't sleep due to high adrenal stimulance, she only slept like 2-3 hours long which she can get from Novocaine with her teeth. She got up 3 times and excreted a cup of urine per time. In the morning, she woke up and excreted 1 cup of urine more than what she usually does. She got herself weighed and had a weight of 109lbs versus the normal 122lbs which indicated that she was really dehydrated so she took her fluids and ate breakfast. Other than this, she mentioned that she got up today and felt fine and feels that in 2 days she will be fine. She felt pretty good and she was going to run but did not dare burn any more calories or fluids so she is sitting still and taking it easy. Regarding outcome of event she reported the pounding pressure like high blood pressure are better, fine# she had a normal breakfast# she can get around and do whatever she needs around the house except she needs now to spend the day recouping from the dehydration so she needs pay attention to what she eats and drinks. She mentions that she runs 3-4 miles a day and tries to be active for her age. She is asking if she can take the 2nd dose in 3 weeks. She is unsure if this is an allergic reaction or something psychological. The outcome of the event was reported as recovering.

passed out; Did not get second Covid 19 vaccine when scheduled; 50 days since las shot; first Covid 19 vaccination lot number says RL3246; This is a spontaneous report from a contactable consumer, the patient via the Pfizer sponsored program. A 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 07Jan2021 at 12:00 (at the age of 80-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included ovarian and endometrial cancer. Concomitant medications were not provided. The patient did not receive any other vaccinations within four weeks of immunization. On 07Jan2021, the patient received the first Pfizer shot. When she went for the second shot, she was waiting outside in the heat (she is a cancer victim) and she passed out so they wouldn't give her the second shot. She mentioned that, then, she couldn't go back because of cancer treatments she was being given and the facility was only open in that community for a certain amount of time. She finally went for a second shot at a different facility ("Institute") but she was told that she couldn't get the shot because "they didn't know if the first shot was real" as they had a different lot number than the Pfizer lot number that she had. She explained further that her first COVID 19 vaccination lot number is recorded on her vaccination card as "RL3246." Her husband's COVID 19 vaccination card says "EL3246" for lot number and they received injections on the same day. The caller believes her lot number should also say "EL3246" - she thinks it's a small written 'e.' The patient added that, as of the reporting date, "It is 50 days since I had the last shot." She also asked if she has to retake the vaccines or if she can just take the second dose. The clinical outcomes of the event "passed out" was not provided.

Patient has chronic autoimmune conditions of ITP and Evans syndrome. Her platelets and other blood counts are monitored monthly by a Hematologist. Her platelets run low usually between 81-100. On her CBC taken 2/18/21, her platelets were 51. On 3/2 they were 47 and on 3/8 they were 34. The first part of March a change in gate was noted in patient, sh fell on 3/8/21 and hit her head. On 3/8 a CT scan detected bilateral subdural hematoma. Certain internal bleeding was believed to be caused by the fall, other bleeding appeared to be present prior to the fall.

- day after vaccine developed cough productive of white mucus, dyspnea on exertion. Finally sought care 3/17 due to progression of symptoms and was found to have bilateral pulmonary emboli. No DVTs. No risk factors for PE. No prolonged immobilization, travel, surgeries, obesity, active cancer. - COVID negative rapid and PCR test on admission. No known prior COVID infection.

Following the 2nd dose, patient felt a "heaviness in chest." March 11th, two days post-vaccination, patient was admitted to hospital via ambulance due to shortness of breath-difficulty breathing. Tests were run, and health continued to decline. Doctors suggest an autoimmune reaction due to vaccine, which then exacerbated her COPD. They found fluid inner lungs.

blood pressure went from normal to 190; feeling her chest tight; couldn't breathe; black spot in her eyes; just a tightness in her throat; sugar is very high; This is a spontaneous report from a contactable nurse (patient). An 80-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 02Mar2021 (Batch/Lot Number: EN9809; Expiration Date: 30Jun2021) as a single dose for COVID-19 immunization. Medical history included diabetic, asthma, allergy, sugar, and thyroid (disorder). The patient also stated that she has a lot of allergies. She was allergic to bees and allergic to bunch of things and many more things. She had her thyroid removed. Concomitant medications included levothyroxine (LEVOTHYROXINE, 100 ug) taken for thyroid (disorder), start and stop date were not reported; metformin (METFORMIN, 100 mg) taken for her sugar, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE, 12.5 pill), taken as diuretic, start and stop date were not reported. The patient reported that she had a very bad reaction from the vaccine, which was 20 minutes her blood pressure went from normal to 190 and she started feeling her chest tight and couldn't breathe (all on 02Mar2021). She also had a black spot in her eyes (02Mar2021). The patient reported that the events started the minute after she got the shot. She was sent to the hospital on 02Mar2021. When she was in the hospital, her blood pressure went up to 244, it is the highest. Her chest was going to have an asthma attack but she didn't develop an asthma attack it was just a tightness in her throat (02Mar2021). She was a day and half in the hospital, trying to get her blood pressure down which went down somehow that she still have over 200 blood pressure. When paraphrased the above concern she stated, "Yeah absolutely want to know what kind of result or what kind of the side effect you are going to have." The patient also stated at the time of report, "I still have my blood pressure is still 200 and my sugar is very high too (unspecified date in Mar2021), is that part of the after effect of the vaccine because I didn't have that before." The patient was hospitalized from 02Mar2021 to 04Mar2021. Therapeutic measures were taken as a result of blood pressure went from normal to 190 (hypertension) and couldn't breathe. The patient stated her doctor put her in the double medicine for the blood pressure. When probed for if patient was still experiencing issue, she stated "No, as soon as I came home I took Benadryl". The patient reported that her breathing improved as soon as she took Benadryl and her chest is probably clear now. As treatment, they gave her blood pressure pills. They gave her Pravastatin 20 mg. Outcome of the event blood pressure went from normal to 190 and sugar is very high was not recovered. Outcome of couldn't breathe was recovering. Outcome of the other events was unknown.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Patient incident report Pt: Allergies: Penicillin 14:45 client claims to feel new onset trembling in her legs bilaterally feel trembly with her second dose of the covid Pfizer vaccine Lot ER8732 Ex: 07/2021, denies feeling any reaction with her first dose, nursing staff was altered-------------------------------------------------------------------------------- 14:52 she has history of high blood pressure and diabetes type II, she denies any chest pain, denies shortness of breath, denies trouble breathing, denies itching, denies rash, vitals taken blood pressure 190/85, pulse 97, SPO2 97% , pain scale 0/10, A & O x4 to person, place, DOB, and situation.---------------- 14:55 client was given a simple sugar and protein to eat14:59 reassessed client?s vitals BP- 199/88, Pulse 94, denies pain 0/10, denies shortness of breath, denies trouble breathing, denies chest pain, denies itching, denies rash, client claims she still feels the trembling in her legs-------------------------------------------------------------------------------------- 15:03Emergency services was called, stood by patient while she was in the car to monitor, client claimed to feel an improvement of the trembling, denies chest pain, denies shortness of breath, denies trouble of breathing denies rash, denies itching------------------------------------------------------------ 15:15Emergency Services arrived to the site started to provide treatment to the client, client claims to feel better still has trembling in the bilaterally legs15:23 blood sugar was taken by the emergency service team reported 138-15:31 client was being transported to Hospital

After vaccination patient claimed she feels dizzy so we told her to sit for monitoring . After 15 min she still felt dizzy so we measure her blood pressure which was really elevated ( 190/110 , 185/100 ) . We asked if she has history of hypertension which she denied . She claims she was feeling fine and that vaccine caused this reaction . She denied being on any medication . We offered to call 911 to take her to hospital but she asked her sister to pick her up and take her to ER.

Acute CVA (cerebrovascular accident) Focal neurological deficit Uncontrolled hypertension Cerebral infarction, unspecified

3 days after receiving 1st shot, I woke up as usual & after putting on coffee I returned to dressing room to put in my eye drops...a morning ritual, and as doing so I completely 'blacked out' & fell against the dressing room counter and floor. I have fainted before and this was nothing like that. I don't think I was 'out' long nut when I cam to I was on the floor afraid I had had a stroke or heart attack..ruling that out I slowly got up and after sitting for a minute, called my neighbor and then she called 91. I was taken to the emergency at Hospital where they ran all kinds of test

reported Blood Pressure jumping/blood pressure shot up; nausea; headache; icky feeling; patient experienced light headedness, dizzy and icky feeling; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 80-years-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6204, Expiry date: Unknown) via an unspecified route of administration in left arm on 10Mar2021 13:30 as single dose for covid-19 immunisation. Medical history included hypertension, caller says she has had hypertension prior to getting vaccine. The patient previously took first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6201, Expiry date: Unknown) via an unspecified route of administration in right arm on 17Feb2021 as single dose for covid-19 immunisation. There was no family history relevant to adverse events. There were no concomitant medications. Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 13Mar2021, patient experienced light headedness, dizzy and icky feeling, on 15Mar2021, experienced blood pressure jumping/blood pressure shot up and on an unspecified date patient experienced nausea and headache. Caller says she has had hypertension prior to getting vaccine. Caller got her 2nd dose, "last Wednesday on 10Mar2021". Caller says she had no issues until Saturday/Sunday. Caller experienced: nausea, light headedness, icky feeling, headache. Caller says she has never had a "continuous headache before". Caller had a pre-existing appointment with doctor that Monday after. During appointment, caller had systolic blood pressure reading of 205. Caller says the doctor "gave me a little orangeish coloured pill, she was monitored after that in office." Caller says she was told to go to emergency room from doctor office. Caller had EKG and blood work done at emergency room and sent home to continue to monitor blood pressure and follow up with her doctor. Caller is asking, "has anyone else reported Blood Pressure jumping". Caller also says, "I know people have headache and nausea, how long does that usual last" Caller asking how long her headache might last. Dizzy/Lightheaded/Icky feeling: She said that she still has a kind of a funny headache. She said that she is never really sick and can't even remember having a cold. Caller said that her blood pressure is currently in the 140's and 150's systolic. She said that it has been high for a number of years, but it has never been as high as 205 that she can recall. Caller said that her blood pressure dropped while she was at the hospital and she was discharged from the emergency room. The caller was not admitted to the hospital. Caller does not remember the diastolic number from her blood pressure. The patient underwent lab tests and procedures on 13Mar2021, which included blood pressure measurement: systolic was 205. The outcome of the events light headedness, dizzy, icky feeling and blood pressure jumping/blood pressure shot up were recovering and nausea, headache were unknown.

On or about March 16, 2021, my left ankle swollen and hot to touch; sought and received medical treatment on March 25, 2021, and after a dobbler and ct scan was diagnosed with bilateral pulmonary emboli. Treated at Emergency Department and placed on Eliquis 5mg x 2 @ day for 7 days and then for 23 day - 1tab x 2 a day.

patient presented to ED 2/6/2021 with CC of SOB. Patient reported that she started having a cough and runny nose 14 days prior to presentation. Patient was admitted due to further evaluation of respiratory failure. Patient was started on IV decadron due to symptomatology and worsening hypoxia. Infectious disease was consulted for this patient and recommended supportive care and dexamethasone. Patient hospitalized for 10 days due to shortness of breath and oxygen requirements.

Blood clots; This is a spontaneous report from a non-contactable consumer through a Pfizer sales representative. An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had blood clots. The patient was hospitalized on an unspecified date due to the reported event. The outcome of the event, blood clot, was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.

Headache, chest pressure (3/10), tongue tingling. BPs 139/75 (pulse 63), 129/64 (pulse 64). O2 sats 96%. Taken to the ED.

March 27,28,29 Severe diarrhea, foggy head. March 29 Altered mental status, symptoms of stroke, loss of memory for short period of time, diarrhea,headache-recurrent. Low sodium levels

9:20 patient complains of burning of tongue radiating down throat, denies chest pain, tightness, tingling, or difficulty swallowing. 9:44 blood pressure elevated, patient was sent home with daughter. 10:02 patient was given Benadryl 25mg x 1 dose. Patient ate food and at 10:18 reports lip swelling and burning. 10:20 patient was given dexamethasone 4mg x 1 dose and Pepcid 20mg x 1 dose. 11:28 patient verbalized improvement of symptoms, patient was advised to continue with Benadryl 25mg every 8 hours x 1-2 days and to follow up with her primary care provider the next day.

high blood pressure; cholesterol; flutter; her hands were red and felt warm; heart pains; she wakes up groggy; pain in middle of her chest; she felt tired/she feels worse; her arm hurt; her hands were red and felt warm; her legs felt heavy; This is a spontaneous report received from a contactable consumer, the patient. A 79-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 04Mar2021 at 17:15 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included blood cholesterol increased from 2011 and ongoing; diagnosed 10 years ago, hypertension from 1991 and ongoing; diagnosed 30 years ago, chest pain from an unknown date and unknown if ongoing. Concomitant medications included atenolol taken for blood pressure from an unspecified start date and ongoing; benazepril hydrochloride, hydrochlorothiazide taken for blood pressure from an unspecified start date and ongoing; nifedipine taken for blood pressure from an unspecified start date and ongoing; simvastatin taken for blood cholesterol increased from an unspecified start date and ongoing. The patient experienced she was having issues with her heart/she also has pain in middle of her chest like heart pains/seems like more pressure and sort of constant, her hands were red and felt warm, high blood pressure, cholesterol, flutter, her legs felt heavy on 04Mar2021, she felt tired/she feels worse on 06Mar2021, she wakes up groggy, her arm hurt on 04Mar2021, she was having issues with her heart/she also has pain in middle of her chest like heart pains/seems like more pressure and sort of constant. Her hands were red and felt warm, had high blood pressure, cholesterol, flutter, her legs felt heavy, she felt tired/she feels worse, she wakes up groggy, and her arm hurt. She states that she could hardly sleep on the left side, so she is going to have it on the right next. The chest pains started a few weeks ago and it started before the vaccine but now it seems like more pressure and sort of constant, not a pain, pain but a pressure that she knows is there. Now and then she feels a flutter. Clinical outcome of heart pain was not recovered, for hands were red and felt warm, high blood pressure, cholesterol, flutter, she felt tired, she wakes up groggy, pain in middle of her chest was unknown, her legs felt heavy, her arm hurt was recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.

Vaccine seems to have affected my A-Fib in that I now have constant A-Fib flutter leading to shortness of breath even while sitting or routine life activities. This was a big change since the administration of the vaccine. Also, my TSH levels were elevated -from 6.4 to 10.4-in less than two months.

was observed post Covid-19 immunization for approximately 1 hr and 45min. Patient complained of being hungry stated she had not eaten all day around. was given water and crackers, said she was feeling better but during further assessment she said she felt dizzy and light headed. Blood pressure right arm 160/103 hr 75. No complaints of chest pain or shortness of breath. She was talkative through out episode. Next BP was 184/91 HR 75. needed to go to the ladies room ambulated to rest room with nurse in attendance. No notable issue with gait. The patient stated that she was feeling better but the blood pressures where elevated. Decided to ask EMT to do a manuel BP in the right arm BP 160/82. Even though was verbal, her responses where vague. One minute she felt fine then she was dizzy. was encouraged to call someone, but she felt she might be able to make it. There was a concern with her driving her self home. EMT performed a cognitive test she stated the wrong year and did not know who the president was when asked in two separate assessments. They also performed a neuro assessment which was uneventful. EMT tried to contact sons but were unable too and patient could not find her phone where we could call a neighbor. EMT suggested that she should go to the ED to be evaluated to be on the safe side and she agreed.

high blood pressure , dizziness , blurred vision , nausea saw doctor , was in hospital 4/15-contacted the patient , patient has been feeing much better for some time , no issues now

Blood in left leg. Hospitalized for 3 days. Now on Eliquist. Couldn't walk on left leg. Had to pull the cord and maintenance called the ambulance. Still having pain in left leg even after a cortisone shot still not better and they don't know why. Next appoint is on Thursday. There is another appoint at the pain clinic for her back pain tomorrow

I have never had a bloody nose, 4/17/21 had a bad one21 lasted 20 min. then 4/19/21,had one in AM, lasted 10 min, had another one 4/20/21 AM lasted 15 min. Im talking bad bloody nose, Later today; I coughed up a glob of blood, Im wondering if this could be from the vacinne, Im seeing q ENT,this Thursday 4/22/21.

very ill and had to be taken to hospital; terrible pains all over; dehydrated; headache; feeling like something was choking her in mouth; coughing real hard; it was breathing and it was like somebody has cranky paper in hand which screaming up that's what breath sounded like; joint pain; patient was like fainting; panicked; allergic reaction/face swollen up; and lymph node was swelling up; white lumps on lip; some white patches on face/couple of patches around mouth; white lips; Short of breath; sore around mouth; face swollen up; pneumonia; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EN6200; Expiration Date: 06May2021) as single dose for covid-19 immunisation. Medical history included insomnia from an unknown date and unknown if ongoing. Patient weight was 155 now. Patient was overweight because this eating and eating. Feeling inactive, not going out so patient gained a lot of weight. Patient took blood pressure medication and for heart some basically and patient didn't sleep well, so patient took Alprazolam to relax to sleep, but patient was an insomniac but that was basically problem. The patient's concomitant medication included isosorbide. Patient had the first Pfizer shot and wasn't even sore or anything, patient was so happy but that about 4 or 5 hours later about maybe 5 o'Clock, patient had allergic reaction and started to feel a sensation in lip and when she looked in the mirror, what was all that on lip and one side on lip it had turned white and it had lump was extended along lip line, lymph node was swelling up and patient had white lumps on lip which still had but it was going down and some white patches on face. Nothing happened on the 24Feb2021. Patient thought it was the 25Feb2021 that was when all trouble started. Patient felt like nightmare because she started feeling like something was choking her in mouth and next minute patient started coughing, coughing real hard and that was terrible cough then after this strange voice and patient realized it was breathing and it was like somebody has cranky paper in hand which screaming up that's what breath sounded like. Patient start to get out of bed and then waken to kitchen, patient had terrible headache, joint pain, pain all over from head to foot and patient was certainly dehydrated. She had no water in at all, she was like don't know something come over and felt like she was sort of leaving the world, patient was like fainting, and panicked. Patient had terrible pains all over and felt like patient was dying, patient was going to die. Patient said she need an ambulance, patient was very ill and had to be taken to hospital. They came within a few minutes, they started questioning about what was happening and they put patient to the emergency room and well they test patient for Covid as well naturally. It was negative, they did it 2 times and it was negative. When they took patient to one of the room in fact patient was frightened because they didn't told patient it was negative. Patient said she got the virus, they said not but patient had to take the oxygen as it's surge to scan on lungs. They said patient had allergic reaction to the vaccine. Patient was supposed to have it but at the same time there was the variant, doctor said patient was 70% covered, didn't have it but patient want to just check the status was with a person like her was allergic. Patient had shots in face and patient did tell them that she had all sorts of things on face. Now patient still had the white lips and couple of patches around mouth and naturally patient was worried like what to do. The patient didn't take the second shot because she was too nervous. Patient went hospitalization on the 25Feb2021 very early, and was relieved on 27Feb2021 (not sure). Reason of Hospitalization: On the University hospital. They put down to the Pfizer injection but that was older happens to patient, they infused patient with antibiotic they gave pills. Patient said she won't be able breath with them and that was what they did, they 'reflect' her, they said patient had pneumonia which she did not have (Further clarification was unknown). Early the next morning they put patient down 2' o'clock in the morning. Patient wanted to go home, they said patient can't as she had very bad infection in lungs which was completely untrue. The next morning (the same morning early), patient was okay because the pains and everything was gone but she believe the medication they put patient on that caused to short of breath and patient said please don't give her the medication and they did. They only give generic medicine in the hospital and patient took brand name. On 26Feb2021 patient actually called the doctor for all results and she told nothing, patient didn't get the result. Anyway they took patient off one medication, they didn't give it to her and this medication you can not get off of it and through that patient had a headache the whole of the day and the whole day on the 26Feb2021 patient was suffering with very bad headache and kept asking for the medication they said they would give to the patient. Finally the doctor gave only to the aspirin and paracetamol (TYLENOL) that both the same and in the end patient husband have to go and get the pill because they still hadn't given it to patient all day long. Patient said to doctor because she was breathing hard and she said the doctor did this to her by giving these pills that don't agree with her. She told she can not take this medication, anyway the doctor said to patient husband go home and get her medication, and he said so now you are medicating yourself. By the next day patient was ready, she was breathing normally and was ready to go home but late afternoon they said patient should go home but she still had those white patches but they were not as prominent as what they were. Patient whole lip turn white, whatever they did, whatever they gave, patient had sore around mouth and face swollen up. Patient didn't know whether she was allergic to the medicine or what but her face, it looked like she had, patient was fine anyway couldn't get an appointment with GP to the Wednesday (unspecified week) but it free appointment on the Tuesday and patient went in and showed him what it looked like. He said it should return to normal within 2 weeks and it but still face like normally excepted lips. Outcome of events pain, short of breath was recovered in 2021, and outcome of other events was unknown. Date of second shot was 17Mar2021, it was reported patient had got the both shot of covid vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021404239 similar report from same reporter

24 hours after second shot fainted; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER2613), via an unspecified route of administration, administered in left arm on 20Mar2021 12:00 at single dose for COVID-19 immunization. The patient's medical history included glaucoma, and underactive thyroid. The patient had no known allergies. The patient's concomitant medications included levothyroxine sodium (SYNTHROID), and latanoprost (XALATAN), both taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198), in the left arm on 27Feb2021 12:00PM for COVID-19 immunization. Facility vaccine type was Physician's Office (reported as Doctor's office/urgent care). The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was tested for COVID post vaccination. It was reported that 24 hours after second shot, the patient fainted on 21Mar2021 07:00. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent case, hospitalization. The patient was hospitalized from 21Mar2021 to an unknown date for 1 day. The patient underwent lab tests and procedures which included nasal swab: negative on 21Mar2021. Therapeutic measures were taken as a result of 24 hours after second shot fainted and included stitches on bridge of nose and lip. The outcome of the event was recovered on Mar2021.

2 weeks after received 1st COVID vaccine patient began having fatigue and dizziness; also having issues with elevated blood pressure; patient states she will not get the 2nd dose of the vaccine

Patient immediately began felling unwell after vaccination. Patient felt "generally unwell" and in a daze. Never alleviated, but second dose received. Patient then developed hypertension, tachycardia and was diagnosed with Afib within 2 weeks of vaccination. Patient was hospitalized and a pacemaker was placed.

soreness; her bowels were a little iffy; Feeling Ill; rumbling bowels; diarrhea; upset stomach; nausea; vomiting; accelerated heart rate; dizziness; fever; chills; This is a spontaneous report from a contactable consumer. A 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EK8730; Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 24Mar2021 14:45 at SINGLE DOSE for covid-19 immunisation. Medical history included arthropod sting, hypersensitivity, sinus disorder, hypertension, blood cholesterol, covid-19.C oncomitant medications included fluticasone taken for hypersensitivity, sinusitis; hydrochlorothiazide, lisinopril taken for hypertension, simvastatin taken for blood cholesterol. The patient previously took z-pak. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No visit to emergency room and physician office. No patient's medical history (including any illness at time of vaccination), relevant tests and family medical history. On 25Mar2021, the patient experienced had minimal soreness, no discomfort, 26Mar2021, she awoke with accelerated heart rate, upset stomach, rumbling bowels, and ran to the bathroom and vomited. Then she had diarrhea. Eventually her heart rate slowed, it was elevated for a while and slowed to normal that morning. she had 6-7 episodes of each- the vomiting and the diarrhea. In between those episodes, she had chills, dizziness, then fever. It rolled along, then her heart rate gradually slowed down. Her symptoms stopped after 2-3 rounds of diarrhea episodes. Her chills came on after she experienced accelerated heart rate. The chills stopped after the first or second throwing up/diarrhea episodes. She had brief dizziness following that. She had a couple or one more episode of throwing up and diarrhea. She got warm, calling it a fever and it did not last long. She has a tendency to get dizziness and takes Flonase to keep her allergies at bay. She thinks the dizziness this time went along with her chills and fever. On 27Mar2021, her stomach had a little discomfort, but nothing major. On 28MAr2021, 02:45 she awakened feeling ill and though she might vomit. It ended up being diarrhea and had 3 episodes of that, spaced out. It was over at 09:00. On 29Mar2021, her stomach was queasy and it went away by evening. On 1Apr2021, she had been experiencing tummy aches, taking Tums and her bowels were a little iffy. Therapeutic measures were taken for dizziness with Flonase. The outcome of the events nausea, vomiting, diarrhea, upset stomach, soreness and abdominal discomfort were unknown and events accelerated heart rate, dizziness, fever, chills and illness were recovered. No follow-up attempts are needed. No further information is expected.

I had an allergic reaction to the Pfizer Covid vaccine; I fell; Passed Out Without Warning and Hit her Face on the Tile Floor; Busted Mouth; Stitches in Mouth; Right Knee Very Sore /Left Shoulder Very Sore and Can't Use It; Black Left Eye; states it was black, blue, purple, green and yellow; Tiredness; Left Hand Pinky Sore; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 11Mar2021 14:00 at age of 80-year-old (Batch/lot Number: EN6205) at single dose for COVID-19 immunization. The vaccine was not administered at Military Facility. Medical history included she has hearing aides but it is hard to hear or understand sometimes. There were no concomitant medications. Prior Vaccinations (within 4 weeks) was the first dose of Pfizer COVID Vaccine (Batch/lot number: EL9267) on 18Feb2021 at age of 80-year-old administered in right arm and no adverse events following prior vaccinations. The patient reported she had an allergic reaction to the Pfizer COVID vaccine, she fell on 11Mar2021, not fainted. On 11Mar2021, the patient passed out without warning and hit her face on the tile floor, experienced busted mouth/stitches in mouth, right knee and left shoulder were very sore, black left eye/it was black, blue, purple, green and yellow, tiredness, left hand pinky sore. The patient was calling about the Pfizer COVID Second Shot; verified Pfizer COVID Vaccine. Her second shot was on 11Mar2021 and on the same day she passed out without any warning whatsoever, and she hit the tile floor and ended up in the hospital for five days. She passed out and didn't remember falling or feeling anything before falling. The patient also has a primary physician, but she had been seeing the plastic surgeon for this. The patient asked what does she do if she needs to get a booster. It scared her to death if she would have to take another shot. The patient asked (name) to hand her a pair of glasses to read the plastic surgeons name. She stated the printing is so small on there. She was supposed to see the doctor on 19Apr2021, but she didn't feel good enough to go see the doctor. For busted Mouth, they put in 3 layers of stitches. The stiches have been giving her a fit because sometimes they come undone and hang down. She had to go back into him and get them cut out twice, and she had another one from last night (18Apr2021). It is very sore. States the stiches inside the lip have not resolved and it was still hard. One part of her lip is soft and one part is hard. It was all hard in the beginning. The stitches on the inside are supposed to dissolve. For right Knee it was very sore and she can't hardly use it. For left shoulder it is very sore and she can't hardly use it. It made it awkward to get in and out of bed when she can't use her left arm or her right knee. Her left shoulder was really bothering her and she may have to go have some more work done. It has been popping and went in and out of the joint. That would be back with her primary doctor. Sore pinky on left hand had recovered it didn't stay that long. Black left eye, it was black and blue purple green and yellow. It cleared up in the last couple of days. She was lucky she didn't break the bone around her eye. Treatment included stitches, hospitalization, given antibiotics and blood clotting shots so she didn't get blood clots, she had 3 of those in her belly. She wasn't allowed to get out of the bed when she was in the hospital. She had a terrible experience in the hospital. For the event onset time, it was at 20:00, they drove home from (place name), which is an hour and something, and they stopped at (place name), came home and set outside and she said she had to go lay down because she was tired. She woke up an hour and half to 2 hours later, got out of bed, sat on side, stood up and got herself together and walked to bottom of bed and went out flat. The events required a visit to emergency room and physician office. For emergency room visit, it was reported on 11Mar2021 at (hospital name); the patient should've called redacted number but didn't, they drove in. The patient was hospitalized from 11Mar2021 to 16Mar2021 at (hospital name). The outcome of passed out, tiredness were resolved on 11Mar2021, outcome of 'black left eye/it was black, blue, purple, green and yellow' was resolved on 17Apr2021, outcome of left hand pinky sore was resolved in 2021, the outcome of fell, allergic reaction to the Pfizer COVID vaccine were unknow, outcome of busted mouth, right knee/left shoulder very sore were not resolved.

Big Blood Clot in left leg; This is a spontaneous report from a non-contactable consumer (Patient). A 80-years-old female patient (Non-pregnant) received bnt162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection), via an unspecified route of administration on 28Mar2021 11:00 as single dose for COVID-19 immunisation. The patient medical history included allergies to Demerol. The patient's concomitant medications were not reported. On 17Apr2021 21:30 patient experienced big blood clot in left leg. Patient was hospitalized for 2 days. The patient underwent lab tests and procedures which included Nasal swab test results negative on 16Apr2021. Treatment received for the adverse event was blood thinners. The outcome of event was Not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained

The morning after Mom's first dose of the Pfizer shot, Dad woke up and found Mom lying on the floor next to the bed. Mom said, "I can't move my arm." Dad called paramedics who checked her. They said her vital signs were normal and left. On 2/9/21 in the morning my da awoke to see that Mom had large amounts of bubbly saliva pouring from her mouth onto her pillow. Dad called paramedics, who said this was a diabetic reaction. Mom had NEVER had anything happen like this before. Mom was very sleepy, could not be aroused, and made only gurgling noises. She was admitted to the hospital for care and therapy. She pulled her own IV out. Mom had to be restrained in the hospital and sedated, due to confusion and worsening dementia. By 2/18 when we spoke by phone mom's speech was abnormally slow and very repetitive. "I'm very tired today" was spoken many times. In morning time mom was able to follow basic conversation. Not so later in the day. Mom came home from rehab on 2/26/21. She was able to walk steadily and independently at home after her therapy. After a week or so, Mom began hitting the in-home caregiver. Dad's presence would calm her. In a short time Mom seemed not to know dad anymore, and would hit him and the caregiver when they helped her. She also pulled all covers off the bed and pulled clothes out of the closet, throwing them all over the room during the night. Mom was usually walking around the house during each night. On 4/16/21 Mom and dad were napping sitting up on the couch in the morning. Mom fell forward and hit her head on the hearth. Dad and caregiver gave first aid and called paramedics, who took her to the ER. Mom came home on 4/17/21. On 4/18/21 Mom pulled her catheter out in the early morning. In the afternoon Mom's appearance was concerning, so Dad called paramedics. They said that Mom's BP had dropped very low and took her to the ER. Mom was combative the next day in the hospital. Dr. adjusted her medications periodically to ensure that mom's care would be manageable when she would eventually be sent home. Minimal therapy was done due to dementia. By 5/3/21 doctor said that Mom is bed bound and needing total care. Her blood sugar spiked high despite special diet. Staff waiting for insulin order from doctor. 5/4/21 Doctor called Dad to say that Mom had died during the night.

patient experienced partial paralysis of face, left face. was taken to the hospital, ruled out a stroke.. diagnosed bell's palsy

This 80 year old white female received the Covid shot on 3/10/21 and went to the ED and was admitted on 3/15/21 with the following diagnoses listed below. Pneumonia Pulmonary embolism

Patient received dose 1 of the pfizer covid vaccine on 1/22/21 and dose 2 on 3/4/21. Patient was diagnosed with COVID on 4/22 at outside clinic after presenting with about a week of cough, nausea and fatigue. On 5/2/21 she presented to our emergency department with persistence of the above symptoms and hypoxia to the 70s on room air and again tested positive for COVID. Initially required BIPAP then HFNC. She was treated with broad spectrum antibiotics for 7 days and dexamethasone for 10 days. She was offered tocilizumab and remdesivir but refused. She clinically improved and was weaned down to 2L NC w/saturation of 93%. However on 5/13 she acutely desaturated and was found pulseless. Patient was DNR/DNI so was pronounced dead.

pain all over body; Chest pain; Leg pain; severe pain on her neck, she couldn't lift her head; Monday morning she couldn't get out of bed.; the red blood cell count was low; the hemoglobin was low; having to use a walker; anxiety; her heart starts racing; has been taking steroids and her weight has shot up like crazy now she is 120 lbs; The platelets which is the ones that do the clotting, normal high is 200 and hers were higher than normal at 760; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. An 80-year-old (currently she just turned 81-year-old) female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 03Feb2021 3:20 PM (Batch/Lot Number: EN5318) as single dose at the age of 80-year-old for covid-19 immunisation, as care provider for her husband, administered at a COVID vaccine clinic setup. Medical history, family medical history and concomitant medications were none. She has been very healthy. Before BNT162B2 first dose, In Jan2021, 2 weeks prior BNT162B2, she got the second dose of shingles shot (VARICELLA VACCINE) for immunization with no adverse effect. No adverse effect occurred following prior vaccinations. No other history of all previous immunization with BNT162B2. No additional vaccines administered on same date of BNT162B2. In Feb2021 she experienced pain all over body with outcome of recovered, chest pain with outcome of recovered, leg pain with outcome of recovered, severe pain on her neck. In 2021 the patient experienced the platelets which is the ones that do the clotting, normal high is 200 and hers were higher than normal at 760, she couldn't lift her head, Monday morning she couldn't get out of bed, the red blood cell count was low, the hemoglobin was low, having to use a walker, anxiety, her heart starts racing, has been taking steroids and her weight has shot up like crazy now she is 120 lbs. The patient underwent lab tests and procedures which included in 2021: haemoglobin: low, platelet count: 760 higher than normal at 760, red blood cell count: low , weight: 120lbs. Therapeutic measures were taken as a result of events. The course of events was as follows: After she got the first dose she had some adverse reactions in 2021: she had pain all over body, chest pain, leg pain, severe pain on her neck, that she couldn't lift her head. She has seen some specialists to seek assistance, she has seen a hematologist, and a rheumatologist. She has been on steroids and she was not yet done with the second dose of the Pfizer COVID 19 vaccine. Her doctor was very aware. When this started 3 months before, she 110 lbs but she has been taking steroids and her weight has shot up like crazy now she is 120 lbs, she told her doctor that she had no more fat clothes she will have to get off of the steroids, they blame everything on steroids. She said nothing else is relevant she was fine, in fact she was dancing the weekend before, that Saturday night she went to a Portuguese evening and was learning to do their dances and Monday morning she couldn't get out of bed. She refused to go to Emergency Room for the events. She has seen her doctor who requested she see a hematologist and a rheumatologist because she was having pain in her legs, she was having to use a walker. The hematologist found that her blood was out of whack. The platelets which was the ones that do the clotting, normal high is 200 and hers were higher than normal at 760, higher than what they call the high normal. The events pain all over body she had chest pain, leg pain, severe pain on her neck may have began a week after the vaccine in Feb2021. The pain was not ongoing, it was gone. They gave her massive doses of steroids she was taking 15 mg of steroids and right now they are lowering it. She had not the pain now but it was worse than childbirth. She has recovered completely from the pain, she felt fine now she has to wait until they take the steroids away again. She stated a lot of the blood, the red blood cell count was low, the hemoglobin was low, everything was low except for the platelets. So they told her to wait. She stated they blame everything on the steroids. Her anxiety started and her heart started racing, they said it was steroids, she was hungry they say it was steroids, she told the doctor she was gaining weight, they say it was steroids. No further information provided. She went to physician on 28Apr2021, the blood hematologist and they say it seemed that most blood work was back to almost normal everything was going down, the treatment she was receiving was working, the platelets were going down. She confirmed she had to wait to come off the steroids to get the second dose and she asked the doctor if she could get the second dose, she still wanted to get it but they told her she has to wait until she is completely off the steroids. The outcome of pain all over body, chest pain, leg pain, severe pain on her neck, she couldn't lift her head was recovered in 2021, of platelets which is the ones that do the clotting, normal high is 200 and hers were higher than normal at 760 was recovering, of she couldn't get out of bed, the red blood cell count was low, the hemoglobin was low, having to use a walker, anxiety, her heart starts racing, has been taking steroids and her weight has shot up like crazy now she is 120 lbs was unknown.

Patient is an 80 y/o right handed female who is totally independent at baseline who received her Pfizer vaccine out of the country (1st dose 2/19/21, 2nd dose 3/12/21). She was reactive to both shots, reporting arthralgias, headache, low grade fever, chills. She had a rise in blood pressure later during the day of her shot as well as the next day (up to 180/70, from baseline of 130/70). She also had an episode of epistaxis several days after her first shot. She traveled independently out of the country on 3/31/21 to visit her son on a leisure trip. On 4/5/21 she had headache, dizziness/lightheadedness, and did not feel well, and her systolic BP was 198, after which she took additional 40 mg of lisinopril. Her BP subsequently decreased to systolic BP of 130 mm Hg on 4/5/21, but over the next few days she had labile BP with a range of BP of 125 to 171/ 58 - 68. She was meticulous in checking and recording her BP several times a day, and she increased her lisinopril dose to 40 mg po qd from 20 mg po qd given the higher than usual blood pressure range. On 4/10/21 her BP was as follows: 6:30 am, 148/60 (she took her daily lisinopril 20 mg po); 11:30 am: 132/52; 3 pm: 171/69 (she took additional lisinopril 20 mg po) after which her systolic BP decreased to 130. Then around 6:20 pm the same day (4/10/21), she had acute onset of headache, vomiting, left sided weakness, SBP 220, and was witnessed to have rapid change in mental status. There was no antecedent trauma to the head. EMTs were called immediately and she had loss of consciousness during the ambulance ride to the ED, after about 20 minutes of symptom onset, with agonal breathing and bradycardia to the 40s, but never lost her pulse. Upon arrival to the ED out of the country, her Glascow Coma Scale (GCS) was 6, she was rapidly intubated and stabilized. Head CT demonstrated massive intraparenchymal hemorrhage (140 cc) within the R temporal parietal and occipital lobes, with cerebral edema and 14 mm midline shift, associated with small subdural hematoma and small intraventricular hemorrhage within the temporal horn and body of the R lateral ventricle. They reported hyperdense "spot sign" within the intraparenchymal hematoma compatible with active hemorrhage, no evidence of venous thrombosis, no masses, no arteriovenous malformations. She had 2.5 mm aneurysm right that was thought to be incidental finding unrelated to her event. She was taken emergently to the OR on 4/10/2021 for decompressive R hemicraniectomy, which she underwent successfully with minimal blood loss. She had no coagulopathy and her platelets and hemoglobin were normal. She remained in the Neuro ICU for 3 weeks. She received a tracheostomy two weeks after her presentation, and was weaned off the ventilator. She is breathing spontaneously after 5 weeks from presentation. She remains in coma or minimally conscious state, with GCS score of 5-6 as of 5/13/2021.

Stroke Sudden fall around 1:15 PM on May 6, 2021. Laceration on head and eyebrow as result of fall. Lightheaded after fall. Loss of feeling on left side. Dystonia of left hand. Arrived at ER around 2:30 PM. MRI Diagnosis: Cerebrovascular accident due to embolism of right middle cerebral artery (HCC) Transferred to Another hospital around 5:00 PM. Treated with blood thinners. ICU for about 24 hours Numerous CT scans and MRI, ECG Normal function of left side restored. Slight loss of sensation remains on left side. Discharged from hospital and returned home. 5/9/21

feeling like I was going to pass out; Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside. Pockets have gone down but are still visible after 6 days.; while in the middle of my wrist large white pockets of fluid appeared, looking like I had a large worm inside.; severe hot flashes; chills; felt like I wanted to vomit; This is a spontaneous report from a contactable consumer or other non hcp. A 80-years-old female patient received first dose of bnt162b2 (BNT162B2 Solution for injection) via an unspecified route of administration, administered in arm left on 12May2021 12:00 (Batch/Lot number was not reported) as first dose, single for COVID-19 immunization. Medical history included obesity, atrial fibrillation, cardiac failure from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously took sulphonamides, beta methasone, prilosec. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. The patient was not hospitalized. On 12May2021 at 12:00 AM, Left side of left wrist turned very red, while in the middle of my wrist large white pockets of fluid appeared, looking like large worm inside. Pockets have gone down but are still visible after 6 days. The worst part, was that got severe hot flashes then chills, feeling like I was going to pass out. Then felt like wanted to vomit. This went on for 24 hours, but now has seemed to stop. The outcome of the events was recovering. Information about lot/batch number has been requested.

her heart beats heavy; she did not lay down back in bed; light headedness/ she experienced dizziness; nausea; This is a spontaneous report from a contactable nurse. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL9265) via an unspecified route of administration, left arm on 02Feb2021 at a single dose (at the age of 80 years-old) for COVID-19 immunization. The patient's medical history included vertigo, arthritis, anemic, muscle spasms, high cholesterol quadruple vessel bypass graft and patient concomitant medications included as atorvastatin, cyclobenzaprine. On 03Feb2021 during the night patient experienced dizziness, light headedness, nausea, heart rate abnormal, activities of daily living impaired. Patient's normally her heart beats heavy but that was normal to the patient. The patient had already been diagnosed with vertigo prior vaccination. Patient paperwork stated that it was not recommended to receive the second dose, but patient wanted to know if what patient experienced qualified for her not to take it. The patient known second dose was higher than the first dose. There were unknown investigations done. The labs from last time patient went for them, they were concerned patient LDL was very low and the cholesterol was off, this was about a month ago. The outcome of the events dizziness, light headedness and nausea was recovered. The outcome of the remaining events outcome was unknown. No follow-up attempts are needed. No further information is expected.

I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - Acute kidney injury (CMS/HCC)

Reduced consciousness; Pain and swelling in the arm where she received the shot; Pain and swelling in the arm where she received the shot; Slight fever; Chills; Heart rhythms; Tiredness; Sudden severe headache; Imbalance; Trouble walking; Dizziness; Vertigo; Slight vision changes; Confusion; Numbness or weakness of one side of her leg; Numbness or weakness of one side of her leg; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO9269), via an unspecified route of administration in right arm, on 10Feb2021 at 14:15 (at the age of 80 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included stroke (few years ago), multiple hip transplants, and rheumatoid arthritis (for 35 years). The patient's concomitant medications included apixaban (ELIQUIS) and metoprolol tartrate. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a clinic. On 11Feb2021 at 16:45 PM, normal side effects felt are pain and swelling in the arm where she received the shot. In addition, the patient may have a slight fever, chills, heart rhythms, tiredness, headache, and imbalance (trouble walking) on 11Feb2021 at 16:45 PM. On the patient's first two days (starting on 11Feb2021 at 16:45 PM), the patient experienced dizziness or vertigo, slight vision changes, sudden severe headache, confusion or reduced consciousness, and numbness or weakness of one side of her leg. It was unknown if treatment was given for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Sudden severe headache", "Dizziness", "Vertigo", "Slight vision changes", "Confusion", "Reduced consciousness", and "Numbness or weakness of one side of her leg" in Feb2021; and from the other events in 2021. No follow up attempts are possible. No further information is expected.

severe headache on 2nd day, exhausted for 3 weeks, mild chills, extreme burning in chest, passed within 12 hours, tingling in hands and arms and itching, low blood pressure, sporaitic left arm and elbow pain, lower stomach cramps, diarrhea, out of breath

Constant throwing up and went into a stroke; Constant throwing up and went into a stroke; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EWO151), at the age of 80 years old, in right arm on 02Apr2021 12:45 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). The patient was not pregnant at time of vaccination. The patient was not diagnosed with covid-19 prior to vaccination. The patient received any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced constant throwing up and went into a stroke on 01May2021 10:00. The patient was hospitalized due to the events. The patient had not been tested for covid-19 since the vaccination. Therapeutic measures were taken as a result of constant throwing up and went into a stroke. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

Chills; Temperature of 100.8F; Diarrhea; Nausea; Fatigue; she was sick; blood sugar got up to 258; This is a spontaneous report received from a contactable consumer (Patient). A 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in left upper arm on 26Feb2021 at 11:15 (at the age of 80-year-old) as a single dose for covid-19 immunisation. The patient medical history included ongoing diabetes mellitus (diagnosed 25 yrs ago. She was keeping control with medication and started insulin in Jun2020), arthritis, pain, ache, blood pressure, blood sugar and blood cholesterol (abnormal). Patient did not receive any prior vaccinations within 4 weeks and did not experienced any AEs following prior vaccinations. Concomitant medications included paracetamol (TYLENOL, once a day, started it probably 10 years ago) taken for arthritis, meloxicam (15mg, tablet once a day by mouth, has been taking for 5-6 years) taken for aches/pain, enalapril (20mg twice a day tablet by mouth) taken for blood pressure (abnormal), glipizide (10mg, 1 tablet in the morning and 1/2 a tablet in the evening with meal by mouth) taken for diabetes mellitus, saxagliptin hydrochloride (ONGLYZA, 5mg once a day by mouth, started about 2 years ago) taken for diabetes/to help with blood sugar, atorvastatin (40mg, once a day, by mouth, started taking it years ago) taken for blood cholesterol, insulin (10units once a day, injection, subcutaneous) taken to control her blood sugar/diabetes from Jun2020 and paracetamol (TYLENOL ARTHRITIS, 2 tablets a day by mouth, started it 10 years ago) taken for arthritis and all were ongoing. The patient family medical history relevant to AE and pertinent details (Include surgical procedures and dates) was none. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9809) administered in left upper arm on 05Feb2021 (at the age of 80-year-old) as a single dose for Covid-19 immunization. On 27Feb2021 at 13:30, the patient experienced chills, temperature of 100.8 F, diarrhea, nausea, fatigue (she could not even get out of bed) and when she was sick her blood sugar got up to 258 and on sunday (28Feb2021) came back down to 96. Chills ended 9 hours after they started, and she was back to normal. Patient received 2 regular Tylenol as a treatment for the events. Patient did not visit emergency room or physician office due to adverse events. The outcome of the event sick was recovered on an unspecified date in 2021, diarrhea, fatigue, her blood sugar got up to 258 was recovered on 28Feb2021 and rest of the events were recovered on 27Feb2021. No follow-up attempts are possible. No further information is expected.

shriveled down and lost it; This is a spontaneous report from a contactable consumer (patient's daughter). An 80-year-old female patient received the second dose of BNT162b2 (PFIZER-BIOTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date, at patient age of 80-year-old, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had to go into the emergency room and have 4 bags of potassium pumped into her because she just shriveled down and lost it and they didn't know what was wrong with her at one hospital so she went to another hospital and was there for 3 days. The reported wanted to know if these are side effects or something else. The outcome of the event was unknown. Information on the lot/batch number has been requested.

her blood pressure, it was a little bit high; little bit shortness of breath; she felt not well; a little bit tired; a fast pulse; This is a spontaneous report from a contactable consumer reporting for herself. An 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Jun2021 as single dose (at age of 80-years old) for COVID-19 immunization. The patient medical history include she still did not see doctor but the last time she saw a doctor was years ago when her husband was in critical condition, for anxiety, and he passed away she still has anxiety off and on. The patient concomitant medications were not reported. The patient had the Pfizer vaccine three weeks ago (Jun2021) and tomorrow (13Jul2021) will be the second shot that she supposed to take, but today (12Jul2021) and during the first week it was fine. she states before she took the first one, and her blood pressure was perfect, she did it twice, but after that, a week later (Jun2021), she felt a little bit tired and fast pulse and it was going on for about a week and she felt not well. She states now she feels better, and she goes to have another shot tomorrow. States on 12Jul2021 (today), she took her blood pressure, and it was a little bit high. It was 144/72 and 71 and sometimes, it came down to 142 so she wondered if it was okay if she comes tomorrow for another shot. She states her doctor was not available, so she wonders if its because of the blood pressure machine, but she did it three times. it was 144/77, 63 and then it came down to 143/71, 72 so was it okay for her to come tomorrow. She did have a little bit shortness of breath for the second week (Jun2021). She wants to know that it was okay if she comes back tomorrow with a little high blood pressure like that she states but tomorrow, it will be her appointment for her second shot and the question was if she could come tomorrow for another shot with a little bit high blood pressure like that because she afraid that the side effect of the second time will be worse than the first one. Caller states she's short and this was not that serious of a reaction because she still keeps on doing her daily tasks, she walks, and jogging around, but with a little bit shortness of breath for the 2nd week in the beginning and a couple days later, and now its coming down, and today she feels good. The outcome of events a little bit tired, a fast pulse, her blood pressure, it was a little bit high and little bit shortness of breath was unknown and the outcome of event she felt not well was resolved on unknown Jul2021. Information regarding the lot/batch number has been requested.

Glaucoma; Crohn's aggravated; Platelet count decreased; Ill feeling; Illness; Confused; Blood disorder; This is a solicited report based on the information received by Pfizer [manufacturer control number: 21K-163- 3983476-00] from a non-contactable (patient) A 80-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE ), dose 1 intramuscular on 14Feb2021 (Batch/Lot number was not reported) SINGLE at age of 80 years for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for crohn's disease. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced glaucoma (medically significant) on an unspecified date with outcome of not recovered, Crohn's aggravated (medically significant) on an unspecified date with outcome of not recovered, confused (non-serious) on an unspecified date with outcome of unknown, blood (non-serious) on an unspecified date with outcome of not recovered, ill feeling (non-serious) on an unspecified date with outcome of not recovered, platelet count decreased (non-serious) on an unspecified date with outcome of unknown, illness (non-serious) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included platelet count: decreased on unknown date. The clinical course was reported as follows: On 14Feb2021, patient received first dose Of COVID-19 Vaccine manufactured by Pfizer. The patient experienced non-serious reactions to covid vaccine/confused/ill/platelet count dropped to dangerous level, glaucoma, illness/blood disease and crohns flare up with humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced reaction to covid vaccine/confused/ill/platelet count dropped to dangerous level, glaucoma, illness/blood disease and crohns flare up. Pfizer biontech covid-19 vaccine was also considered suspect. Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.The action taken in response to the event(s) for adalimumab was dose not changed . Reporter's causality for Humira for Crohns aggravated was "Reasonable possibility" while for the other events was "No Reasonable possibility" Reporter's causality for PFIZER BIONTECH COVID-19 VACCINE was not reported for all events . The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The events glaucoma, Crohn's aggravated, blood disorder, and platelet count decreased more likely represent intercurrent medical conditions in this 80 yo patient and are considered unrelated to the suspect drug. Patient was using adalimumab for Crohn's disease. Adalimumab may have contributed to decrease in platelet count and blood disorder given is known safety profile. Events malaise and illness are possibly related to the suspect drug based on known drug profile. The remaining event confusion is attributed to intercurrent or underlying conditionsin this 80 yo patient, and are considered unrelated to the suspect product. This case will be reassessed upon receipt of additional information.

both forearms ache; chest felt heavy; lips swelled; eyelids drooped; hands were weaker than usual; whole right side was weak; she could not eat; could not digest food; Lost weight; she got continual heartburn and burped throughout the day after she ate; felt burning; Her stomach was knotted, she could feel her stomach closing up on her; Her stool was mush for the whole three months, it finally got to droplets that turned to mush.; it affected her digestive system and her release of the stools.; Her forehead was very much wrinkled; has a lot of food intolerances and it is not new that she is intolerant; This is a spontaneous report from a contactable consumer or other non hcp. An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration, administered in Arm Left on 01Mar2021 (at the age of 80-years-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She does not take pills. She takes vitamins but states that does not count. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9262) via unspecified route of administration, administered in Arm left on 08Feb2021, in the morning around 9:30 or 10am (at the age of 80-years-old) as dose 1, single for covid-19 immunisation. It was reported that she thinks she should report the difficulty she had with the vaccine since it was not the usual adverse reactions and it was extended. She went to doctor several times. She was wanted to know how to deal with it. Clarifies she does not have a question since this was no longer part of her system. She woke up every morning between 05:30 and 07:00 am and was awoken by both forearms aching. Then it got to where the right forearm ache was worse than the left. Sometimes she felt burning. Her chest felt heavy. Her lips swelled. Her eyelids drooped; left eyelid drooped more than the right eyelid. Her whole right side was weak. When she wrote her right hand was weaker than usual. The worst reaction was that she could not eat, she could not digest food, her digestion was completely off. When she went to doctor, she weighed 92 pounds since she got continual heartburn and burped throughout the day after she ate, and this continued for hours. She had to make special food for herself since she could not digest/ eat most food. She ate fish, bread, and potato. She could not digest anything heavy. Her stomach was knotted, she could feel her stomach closing up on her. She was fearful of eating. Her stool was mush for the whole three months, it finally got to droplets that turned to mush. The main thing as she said, it affected her digestive system and her release of the stools. She lost 8 to 10 pounds. She kept a diary of her food and feelings for months. Her forehead was very much wrinkled, she has wrinkles anyways since she was old, but she had wrinkles in her wrinkles. She had a lot of food intolerances and it was not new that she was intolerant. Her body had many intolerances such chocolate, lactose, nuts, and some medications. She cannot eat anything with any chemicals such as msg and yellow food dye. She cannot eat deli meat since it contains some chemical. At first, she didn't realize it and did not know what was going on with her body, she noticed the side effects mentioned above more after the second dose which was given on 01Mar2021. It took three and half months and finally went it all went away, recovered completely. The patient was recovered from all the events on an unspecified date. No follow-up attempts required. No further information expected.

Lip swelling; Burning lips; Blood pressure elevated; Burning of tongue radiating down throat; This is a spontaneous report from a contactable other health care professional, the pharmacist. A 80-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via intramuscular route of administration in the left arm on 15Mar2021 (at the age of 80-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, hyperlipidemia and penicillin allergy. The patient previously received codeine (MANUFACTURER UNKNOWN), vicodin (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. It was unknownif the patient was diagnosed with COVID-19, prior to the vaccination. Since the vaccination, it was unknown if the patient had been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 09:20, the patient complained of burning of tongue radiating down throat, denies chest pain, tightness, tingling, or difficulty swallowing. On 15Mar2021 at 9:44, the patient blood pressure was elevated and the patient was sent home with daughter. On 15Mar2021 at 10:18, the patient experienced lip swelling and burning, it was reported that the patient ate food. It was reported that on 15Mar2021 at 11:28, the patient verbalized improvement of symptoms. Therapeutic measures were taken as a result of reported adverse events burning of tongue radiating down throat, blood pressure was elevated, lip swelling and burning included treatment with BENADRYL 25mg, once daily, dexamethasone (MANUFACTURER UNKNOWN) 4mg once daily, peptic (MANUFACTURER UNKNOWN) 20mg once daily. It was stated that the patient was advised to continue with BENADRYL 25mg every 8 hours once a day for2 days and to follow up with her primary care provider the next day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events burning of tongue radiating down throat, blood pressure was elevated, lip swelling and burning were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 18Mar2021 (at the age of 80-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Feb2021 (at the age of 80-years-old) (Batch/Lot number was not reported) for COVID-19 immunisation and had pain in her arm. The patient reported that she had first shot on 25Feb2021 and followed the procedure 21 days later and received second shot on 18Mar2021 after the first shot. When probed for second shot vaccination timings, consumer stated, "her second shot was on "319" (Further not clarified). On 19Mar2021, she woke up and her teeth were killing her like she slept she was fine but in the morning she had terrible toothache and she was taking care of her teeth, she had Flu like symptoms her eyes puffed up, swelled and runny nose, she went to a Dermatologist Doctor and she gave her some medicine to take swelling down, she had severe leg cramps and could hardly barely walk. She was trying to find out if she could have blood clot, she could have everything, she went to funeral and she had to leave early, she left and fly back Home, it disturbed her, it could be from Pfizer shot. She was 80 years old and she was not be able to, she should be hardly be able to function. Consumer stated, she was in pain and on pain medication, she was in terrible pain because her legs and back hurting so much. Her eyes swelled up badly. When probed for any laboratory test, consumer stated, she had pain today, she walks 3 miles a day, today she probably walked a mile and it was painful. She went Dermatologist for her eyes. Consumer stated, she went to a Dermatologist to see why her face is swallowed up. She would like to be followed up, what she was to do with her pain, she was like crippled, she was in pain all the time, she would like to know Pfizer to tell her what medication she needs to take. She did not know, the Doctor knows what to give. She needs them to recommend what they are giving to other people those are having these severe reactions. Consumer stated, she had two Pfizer shots (both doses) and she had a severe adverse effect. Now it was difficult she had severe pain in her legs. she walks 3 miles a day. she had her eyes swell as well, she went to a Dermatologist. She walks to her Doctor after the severe pain from the Pfizer shot, he gave her some pain treatment Tramadol and "Ibuprofen" (not clarified) besides the fact that it will help. She started to walk, she sneeze a lot, swelled up like her eyes swelled up and she had sticky stuff that was for 9 days, no apparent reason then she went to the Dermatologist. She had severe swelling then she had her teeth ache, for eye condition and skin she went to Dermatologist and he gave her "Hydrocortisone" (name not clarified) several days for two weeks and her teeth have no pain in her teeth. She woke up this morning and felt cry it was painful and she don't know what to do about this adverse effect. she wanted to ask to Pfizer people to get medicine. The caller has had severe adverse effects after receiving the Pfizer Covid 19 Vaccine. The caller could barely use her legs, the legs were in severe pain. The caller was a person that walked and exercised, walked 3 miles a day. The caller could barely get around, and up and down in the morning is hell. The caller was so weak and the legs hurt so bad. The other effect was the caller's eyes swelled up and ran sticky oozy stuff. The caller went to the dermatologist and was given cortisone and after 14-15 days that cleared up, it was white. The caller went to her doctor about the pain in her legs. The caller was taking Tramadol and Ibuprofen and they were not a lot of help. The doctor said it will run its course. The caller asked how long it will be and the doctor said the good news is it will go away and that is about all the doctor would say. In the mean time, the caller was in severe pain and is asking what can be taken for the legs. The caller states she had been in severe pain since February. The caller states if she is not going to get any help why this was not put on the news report. All it is go get another shot. No reports on how it may have these adverse effects. Another thing is the caller goes to bed at night fine and wakes up in the morning with jaws and teeth killing the caller. The caller had excellent dental work. The caller's eyes still run, continually run. The caller states she specially asked what the caller can get for some relief from the pain or is the patient to call the rest of her life. The caller states she could walk. The caller said Pfizer doesn't report a thing, no side effects, everybody is shut up on tv. The caller thinks the side effects, percentages and dangers for the elderly like the caller and the young, young children should be told. The caller states she did talk to her doctor and he gave the caller tramadol (50mg, Expiration date: 12Jul2022) and Ibuprofen (Expiration date: 21Jun2022). Outcome of the event toothache was recovered in 2021; eye discharge was not recovered; other events was unknown. Information about the Lot/batch number has been requested.

was extremely comfortable not at all nervous or scared to begin, bp 160/102, 15 mins later bp 253/127. Third bp check at 11:25 bp 131/86 10 mins later bp 129/84.

Resident became hypotensive, chest pain, low O2 SAT, diaphoretic, body aches, fatigue and chills on 1/14/21. Second episode on 1/15/21 of nausea, body aches and lethargy.

Within 15 minutes of the injection, the individual became aphasia and stroke like symptoms. She was taken to the ER where she was later diagnosed with a cerebral hemorrhage and passed away.

fast heartbeat, dizziness and it took about 45 minutes to feel better. Had a bad taste in her mouth received Gatorade. On Saturday I felt nausea and just not feeling good and terrible taste in her mouth. Denies any shortness of breath during this entire time. Needed to eat to make her stomach to feel better, chills. injection site sore. Sunday felt better and Monday was almost normal and Tuesday no complaints.

Unsure of the site. this was administered by the Walgreens staff at our branch. She reported on 1/27/2021 that she had leg pain, weakness, SOB heart racing. She reported this started on 1/26/21 overnight but did not report. VS T102.0, P-108, R26, BP152/66 POX 96% on RA. This nurse unsure if this needed reported called the Walgreens pharmacy and spoke to the pharmacist per Walgreens covid 19 rep. Pharmacist instructed to report.

Bleeding/felt blood on her arm /blood was coming from the top of the band aid; This is a spontaneous report from a contactable consumer reporting for self. This 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3248) via unspecified route of administration on 14Jan2021 02:00 PM at right arm at single dose for COVID-19 vaccination, clopidogrel (manufacturer: Aurobindo, lot# QR7520022-A, expiry date: Apr2022) oral from Dec2020 at 75 mg once a day for TIA (Transient ischaemic attack). Medical history included TIA from Aug2019. She had her first TIA Aug2019, and then had her second a couple months ago, it was not as severe, the buildings moved and she walked like she was drunk, but had only one other thing than walking funny and buildings moving, she can't remember what that was. Pain, blood cholesterol abnormal. Pain in both of her arms, she said her left arm hurt more than her right arm from time to time, and when the left started hurting she took all the pills, but she didn't take Hydrocodone though it is prescribed, she didn't take that unless she was in a lot more pain than usual. She said her doctors said different things about her arm pain, one said she had a torn rotator cuff, another said arthritis, someone else said it was something in her neck but it was a big word that she didn't know, she just knew she had pain. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN, manufacturer: Bayer, UPC number: 349483 48150) from Aug2019 for TIA; carbamazepine from Jan2021 for pain in both of her arms; metoprolol succinate, had been taking it a couple years; zolpidem; hydrocodone for pain (she only takes if she is dying of pain, clarified to being in a lot of pain); atorvastatin for cholesterol. The patient reported that she had COVID-19 and experienced side effect. She said it happened after the 15 minutes observation when she left to drive home on 14Jan2021. She said 5 minutes into her drive she felt blood on her arm and put her hand in her shirt, and wiped it, saw blood. She said the bleeding was weird so she pulled over to look at her arm, and blood was coming from the top of the band aid where normally it would seep down from the bottom. She used five baby wipe, and wiped a lot of blood, until finally she thought it stopped bleeding. She was not light headed or in pain, it was a 45 minute drive and she got home and was still bleeding so she took her shirt off and put a towel around it to stop the bleeding and it finally stopped. She said she didn't think to report it until her doctor said to when she told him, he had said maybe the girl who gave her the shot hit a vein, but she should tell them. She said maybe she did hit a vein, because she had never had problems when getting a shot or more than a spot of blood in the past. She said one thing that may be important was that she had a couple of TIAs, many series (unable to clarify) her doctor friend assessed that with three MRIs and MRAs. She said she just refilled one of her medications, Clopidogrel, and was reading the instructions for it and it says it can cause excessive bleeding. She said that she was not bleeding so she didn't worry about it, that maybe that caused excessive bleeding. She had not had a second dose, but she didn't want to go through this again with the bleeding, though if it was just a vein or air that may not happen. She said she was very healthy, no underlying conditions at all, never had a problem before, her arm was not painful, she was not light headed. She said the baby wipe she had on her arm after the car ride was full of blood, and she still couldn't get the band aid off, so she wrapped her arm towel kept sopping up blood until finally it quit. She put another band aid over the bloody band aid, and it quit and she was fine. She had no injection site pain, no tiredness, no headache. Lab data included she had MRIs and MRAs, but there was no bleeding. The action taken for clopidogrel was unknown. The outcome of event was recovered.

My body aches/My whole body is aching; Fast heartbeat; I have difficulty in breathing; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration from 17Jan2021 at 0.3 mL single for COVID-19 immunization. Medical history included immunotherapy for breathing, for her lungs. Concomitant medication included umeclidinium bromide, vilanterol trifenatate (ANORO) for immunotherapy for breathing. The patient whole body was aching from the shot (Later clarified as COVID 19 Vaccine Pfizer) that she got yesterday (on 17Jan2021). She had fast heart beats and she had difficulty in breathing and her whole body was really aching. Her whole body aches and pain of her body. The patient wanted to know how to get rid of the pain. The patient thought that she took treatment included Advil. And patient was still achy. The due date for next shot was on 07Feb2021. The patient underwent lab tests and procedures which included heart rate fast on 17Jan2021 and had lab work last week (in Jan2021), that was for her blood work. The outcome of the event whole body was aching was not recovered, of the rest events was unknown.

Following the vaccine, the patient reported feeling "loopy" and a "little nauseous" about 20 minutes after vaccine was given, and attributed this to likely not having eaten earlier. The patient was found not to be diabetic and was given some crackers, juice and water. She was offered to go to a private room for further monitoring, but declined. Her condition did not improve, so she was taken to a private room for monitoring and observation at about 2:30PM. Vitals were taken, she was still feeling poorly and had very high blood pressure (>200 systolic). She declined the ED. At 2:40PM, her blood pressure did not decrease, so the ED was called to take her in, and she agreed.

Extreme headache, neck ache, for five days; elevated BP 180/90. 160/88, etc. De. prescribed additional BP medication after a week, and BP is gradually coming down...I hope.

Dizzy; Headache; Joint pain; Fever; Injection site swelling; heartbeat would accelerate for a few seconds; Chills; off balance; throwing up; she could not drive and was half delirious; I am not feeling good; sneezing; has no energy; her bowel movement was little dab and then again another little dab; if she does not blow her nose, it feels like something is going down the back of her throat; She still has a punchy feeling; she does not have her peripheral vision right; Her arm felt like a boil where they gave her the shot.; Her arm is still is sore; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982, Expiry Date of Pfizer covid vaccine: May2021), intramuscular injection in left shoulder on 21Jan2021 13:00 at single dose as preventative, since she did not want to get COVID again/there was a new strain of COVID that was easier to catch. Medical history included ongoing high blood pressure diagnosed about 5 to 7 years ago, ongoing high cholesterol diagnosed about 5 to 7 years ago, thyroid disorder, Supplementation, for bones, COVID-19 from Nov2020 to Dec2020: She had COVID in Nov2020 till the end of Dec2020, and she was getting better. Concomitant medication included ongoing metoprolol tartrate for high blood pressure, ongoing simvastatin for cholesterol, ongoing levothyroxine for thyroid, ongoing colecalciferol (VITAMIN D) as Supplementation, for bones. The patient experienced chills, off balance, dizzy, headache, joint pain, fever, injection site swelling, heartbeat would accelerate for a few seconds on 21Jan2021, throwing up in Jan2021. The patient spent that whole night getting up and down and going to bathroom for bowel movement, and her bowel movement was little dab and then again another little dab. She was throwing up by 3am or 4am that night, she threw up twice and reports it was like bubbles. Her side effects started Thursday night. She experienced chills, joint pain, fever, injection site swelling, her heartbeat every so often would accelerate for a few seconds. She dizzy and off balance when she would get up to go the bathroom. Since then she still had sneezing and she was blowing her nose, and if she did not blow her nose, it felt like something was going down the back of her throat. She wanted to ask how long she would experience the side effects and how many people had a problem with the first dose. She still had a punchy feeling, had no energy. She could lay down and fall asleep at almost anytime. Height: about 5'2'', she jokingly stated she was shrinking monthly. Her chills started Thursday night and by Saturday morning they were completely gone. When she tried to turn a corner and reported she did not have her peripheral vision right since she kept running into door frames. She was a little better, sometimes she could walk a straight line and sometimes she veers. Headache was ongoing. She did not have it today, it was not a severe headache, it was more irritating than severe. Her arm felt like a boil where they gave her the shot. Her fever went away Saturday night or Sunday morning. She felt like she was not in her own mind, like she was drifting, so time lines for side effects are hard to recall. Her arm was still was sore. Heartbeat would accelerate for a few seconds was occasionally still happening, it happened last night. She called the hospital (facility where it was received) back the next morning and she was told she could come if she wanted to but it was suggested to stay home and sleep it off. She told them she could not drive and was half delirious, she was told she could call an ambulance to come get her. She confirms she did not call ambulance or go to the hospital. When querying indication, she was told there was a new strain of COVID that was easier to catch. The outcome of events chills was recovered on 23Jan2021, vomiting was recovered on 22Jan2021, joint pain was recovered on 24Jan2021, fever recovered in Jan2021. The outcome of events balance impaired NOS, dizzy, vaccination site swelling, Peripheral vision defective was recovering. The outcome of event headache, sneezing, feeling of total lack of energy, feeling abnormal, sleep excessive and pain in arm was not recovered. The outcome of rest events was unknown.

"While in the waiting area after receiving her vaccination Pt. developed chest pain with changes in skin color. She denied any shortness of breath. BP 179/71 P 66 R16 SaO2 96% 911 was called Pt. was transported to hospital." Per RN. Paramedic documented. "Post vaccination pt started to become very light-headed and had near syncopal episode, also c/o chest discomfort over L anterior chest, denied any shortness of breath, Pt was evaluated 911 called, Pt was transported to hospital for evaluation w/VFD and AMR."

Within 15-minutes of vaccination, the patient reported that their "arm was getting tight and tingling". EMS evaluated patient on-site. Patient was hypertensive (160/86), but otherwise vitals were WNL. Patient refused transport to hospital.

About 2 days after the injection, my heart started beating very hard. It was not a rapid beat but noticeably hard. Saturday and Sunday I stayed prone which seemed to feel better. On Monday, it seemed better and I had an EKG at my cardiologist?s office which came back fine. No trouble since then. Now I?ve just had my second shot.

Systemic: Blood Disorder (diagnosed by MD)-Severe, Systemic: Cardiac Disorder (diagnosed by MD)-Severe, Systemic: Other- Acute Kidney Injury, Hypoxia; lasted 10 days

Swollen tongue. Swollen neck glands. Headache, Racing heart. Blood pressure went to 190/95 Occurred after I arrived home. Called Fire Department. I was still able to talk and breath so they did not use Epi pen. Stayed with me because of BP concern. Offered to bring me to Hospital. Said to take Benydryl if symtoms began anew and to call them back and they would take me ER but as day progressed, symptoms subsided somewhat. Higher BP readings continue and my PCP prescribed mild BP RX..

Approximately 75 minutes after vaccine had significant shortness of breath, extreme fatigue (difficulty walking to the bathroom). Over the next week and a half, blood pressure and heart rate swung widely (outside of normal range). Heart rate periodically dropped down into 30-40 range. Experienced whiteouts.

My blood/glucose level was abnormally high for two days following the vaccine My diabetes symptoms were more prevalent( thirst, frequent urination, dry mouth, diarrhea)

my head and ears closed down; my head and ears closed down; she doesn't sleep all night long; her body was shaking; my heart was beating out of my chest; felt a little lazy and tired; tinge-y pains in her heart; SVT; shortness of breath; This is a spontaneous report from a contactable consumer (patient). An 81-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261, Expiry date: 31May2021), via an unspecified route of administration on 19Jan2021 at Single Dose (dose unknown; by injection once to left upper arm) for covid-19 immunisation, levothyroxine sodium (SYNTHROID), orally from an unspecified date to an unspecified date at 0.75 mg once a day, and orally from an unspecified date to an unspecified date at 0.88 mg, once a day for thyroid disorder. Medical history included cancer, heart stents, irregular high blood pressure, breathing problem, underactive thyroid, back problem. The patient's concomitant medications were not reported. The patient took a flu shot 20 years ago for immunization and got really sick, took Pneumonia shots for immunization and was fine. On 19Jan2021, the patient had a little lazy and tired. On 21Jan2021, her heart was beating out of her chest, like she had a drum going off; beating so fast and rapid it, and her head felt closed off and ears- she could feel heartbeats in her head; on 21Jan2021, her body was shaking. In Jan2021, she had a couple tinge-y pains in her heart and shortness of breath; she had SVG, she thought, it was irregular heartbeats coming from the top of her heart. Details were as follows: On 22Jan2021, she woke up in the morning around 3-4 am and said "my heart was beating out of my chest and my head and ears closed down." The sensation subsided by 8 am. She called her family MD who did not respond so the following Monday she was in contact with her cardiologist who put her on a Holter monitor for a few days. He later told her she had SVT and prescribed a beta blocker for her to take. The patient stated "I am so allergic to medicine." She took Plavix after a stent 5 years ago and was fine taking it for a few years. Then she had another stent placed, was prescribed Plavix again, and was "so sick and dizzy and short of breath - it was the Plavix." States that she can take Cipro, ibuprofen, and synthroid and that her list of allergies is about "2 pages long." The patient wanted to know if she should take the second dose? her cardiologist advised that she not take it. Caller states she doesn't want to take the second dose and probably won't. She had a long history of allergic reactions to medications. She never had the flu, she hasn't had mumps, chicken pox, measles, occasionally, rarely a cold, about 20 years ago, she took a flu vaccine and got so sick after the shot and never took it again, she never got the flu, she does take Pneumonia shots and was fine. States she seems to have a natural immunity against typical disease you can catch. Other things, she had cancer, heart stents, and things of that sort, as far as infectious diseases, she had no problems. She had a reaction she thinks came from the COVID shot. She had a blood test and it showed her thyroid went a bit more underactive, so about 2 weeks ago, her Synthroid was raised from 0.75mg to 0.88mg, so 0.88mg was a new medication, but it was minimal. Communication: Caller was advised to slow down to assure accurate documentation. Synthroid 0.75mg: no NDC, lot, expiry. States this has been her only change in meds recently. She got that Synthroid the same day as she got her COVID vaccination, which was 19Jan2021, that afternoon, she got a Pfizer COVID vaccination. Also she got a prescription for her new Synthroid. The first day, 19Jan2012, she had no reaction at all, she took two Tylenol, someone suggested. She felt a little lazy and tired, for the rest of Tuesday, then Wednesday she felt more tired, she laid around on the couch watching TV, she stayed in her pajamas, had no serious reaction, just tired, then Tuesday and Wednesday, and then on Thursday night, she never did anything on Thursday either, she went to grocery store, was not feeling better, and on Thursday, 21Jan2021, at 3AM, she was awakened from sleeping, she did not sleep all night long, she got up often, her heart, she never had this before and had 3 stents, her heart was beating out of her chest, like she had a drum going off, it was beating so fast and rapid and her head felt closed off and ears- she could feel heartbeats in her head, and this went on, she didn't want to call, she lives by herself on a farm, and thought to wait and see if it goes away, and about 7AM, it was basically really bad from 3AM to 5AM, and at 7AM it went away, the rapid heartbeat was so far throughout and her body was shaking, and chest was so she never had it happen before. At 8AM she called her family doctor office, she wanted to go and see them and she was told she wasn't in that day, they would send a note in the computer to get back with her. The doctor did not get back with her all day Friday, and then she felt ok Friday, Saturday, and Sunday, she had a couple tinge-y pains in her heart and shortness of breath, but her heart didn't feel like it was beating out of rhythm. Then Monday morning she called her heart doctor, he said he doesn't know, it doesn't sound to him like it was the Synthroid, since it was a small change of dose, but he didn't know about COVID but he hadn't heard it as being an after effect, but he said to come by 2:30PM on Monday, to be fitted with a heart monitor, which she wears on her heart and it listens 24/7, listens to her heart function, so she wore that, he said to bring it back on Monday and leave it in the office, and she did that, she wore it Friday, Saturday, Sunday, and Monday, she never had that really huge feeling in her in heart anymore, she thought it was a waste of time, then she got a call from the heart doctor on Tuesday, he asked how she was feeling, she said she was fine, and sorry if she caused a commotion and he said she has a heart problem now, she said she didn't feel anything, but her heart is beating erratically, and he doesn't know why she didn't feel it, he said she has SVG, she thinks, it is irregular heartbeats coming from the top of her heart and he says he will send in a prescription to the pharmacy to get a beta blocker, she thinks Metoprolol. The pharmacy just got the medicine in and she is sitting there waiting now. He told her a couple months ago, her heart sounds fine, there seemed to be nothing the matter. She asked if it was the COVID vaccine, he said he doesn't know, and she asked if she should take the second dose on 09Feb2021, he said no, he doesn't think he wants her to take it, she is going to see him in 2 weeks and will try the medicine, but she wanted to report what happened to her. Has Pfizer heard of anyone having rapid heartbeat after COVID vaccination. States she is overweight. Second dose is scheduled for 09Feb2021, at 1PM. Caller states going from 0.75mg to 0.88mg on Synthroid is a minimal adjustment, it can go up to the 200's for underactive thyroid, it's minimum, she is supposed to take it on an empty stomach, first thing in the morning with water. She has had underactive thyroid since she was 20 years old, so for 40 years, and had no problems with Synthroid before. The patient had irregular high blood pressure: it is high during the night and normal during the day, and if she would take, she had been going to physical therapy, she had a back problem, it came from a different thing, her knee is bone on bone, and they want her to get a knee implant, but when she limps on her knee it makes her back, it hurts from not walking straight, so she went to physical therapy, and what was causing high blood pressure, if she took Ibuprofen or Aleve, it would significantly increase her blood pressure, so she has a sensitivity to pain medicine, especially Ibuprofen and Advil, it increases her blood pressure, and often when she doesn't have it in her system, her blood pressure is much more normal. She does not have Ibuprofen, Aleve, Advil to provide lot/expiry, she is in her car. She is interested, she feels she won't take the second vaccine, she wants to see what they say, she also wants to ask how much protection with just the first shot? The action taken in response to the event for levothyroxine sodium was unknown. The outcome of the events heart was 'beating out of chest', 'head and ears closed down' was recovered in Jan2021, of other events was unknown.

10 minutes following vaccination, patient complained of dizziness and feeling warm. Vitals showed elevated blood pressure 193/78, normal pulse, oxygenation, and temperature. She noted mild improvement in symptoms after 30 minutes, but patient was still unsteady to ambulate independently. BP remained elevated 189/73, 191/86. She denied headaches, SOB, chest tightness, difficulty breathing, GI symptoms, rash. Patient noted history of intermittent elevated BP with systolic measurement in 250s, but no diagnosis of hypertension or hypertensive medications. She reported feeling well this morning and having normal breakfast prior to appt. Ambulance transport was called due to hypertension and persistent dizziness. Patient refused transport upon arrival and was taken by personal driver.

Platelets dropped significantly after taking the shot. Prior to the shot my platelets were 241.; Extreme fatigue; weakness; dizziness; heart racing; nose bleeds; unable to walk or stand up without assistance; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer Biontech; lot number: unknown; lot unknown reason: true received at hospital & not sure what batch they gave her) via an unspecified route of administration at right arm on 16Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other vaccine in four weeks. The patient was not pregnant. Facility type vaccine was at hospital. Adverse events were reported as follows: platelets dropped significantly after taking the shot. Prior to the shot her platelets were 241. Extreme fatigue, weakness, dizziness, heart racing, nose bleeds, and also was unable to walk or stand up without assistance - overall poor health. Condition intensified to severe 1-3 days after the shot and she went to the (Hospital Name) ER on 26Jan2021. She was admitted to the hospital. During that stay her platelets dropped to 142 first day there then 126 when she was released from the hospital. A week later she went to (Name) MD for a planned office visit & my platelets were tested again and her platelets how now dropped to 89. A week after this she went back to (Name) MD and her platelets dropped again and this time now 47. Prior to the shot she have no history of low platelets or this type of unusual she'll feeling. The adverse event start date was reported as on 24Jan2021. AE resulted in emergency room/department or urgent care, hospitalization for 4 days. It was unknown if treatment received for events. The outcome of events was not recovered. No covid prior vaccination. Covid test type post vaccination included Nasal Swab on 26Jan2021: negative. Information on the lot/batch number has been requested.

Pt began feeling poorly, low energy after 24 hours. Increasingly short of breath, not really communicating clearly, enough that I (her daughter recommended that the Dr come. He sent for the paramedics due to low oxygen and something not being quite right. AT hospital multiple tests were run and bacterial pulmonary pneumonia along with heart failure exacerbation was diagnosis. She had been in her room for 2 weeks prior, with no contact with the outside world.

Patient became flush and light headed after her 2nd shot of Pfizer. Patients BP was 140/78 and continued to rise to 170/80, pulse dropped from 78 to 62, patient developed facial redness and after 90 minutes of observation she became to feel a lump in her throat. No difficulty breathing or respiratory issues.

COVID 19 Pfizer - 2nd dose, 2/16/2021 Lot number - EL9261 - About 48 hours later, I got this pain breastbone. I couldn't turn over to the left or right when down because of the pain. It was not shortness of breath. It was pretty bad. This pain lasted about 3 weeks. Soreness is my arm appeared the day of vaccination but that went away within 2 days. I also kept sneezing non stop, and my nose was runny this also started about 48 hours after vaccination. It is better but not completely gone yet. The sneezing is not constant, as of today but still there.

Shortness of breath and chest pains immediately after administration. Transported to hospital. Outcome unknown.

On Sunday, February 21 at 07:42 AM I received a call from patient advising me she had called for an ambulance, she was awoken from her sleep with a rapid heart beat and was also suffering from shortness of breath. Patient was taken to Hospital where she was admitted due to a Pulmonary Embolism, a small clot was found in her lung.

Became lightheaded within 5 minutes after receiving the vaccine. Initially thought it was because she had to stand and walk for over an hour before receiving the vaccine and had not had much to drink or eat. Dizziness/ lightheadedness continued off and on for 10 hours. She also experienced a rapid heart rate (90-100 bpm, which is high for her) and elevated BP (140/80, also high for her) that started about an 2 hours after receiving vaccine. The increased heart rate and elevated BP occurred intermittently over the next 10 hours and she also felt occas. palpitations. After the 10 hour period she felt fine

RECEIVED FIRST DOSE OF PFIZER COVID VACCINE ON 02/21/21. WENT TO ICC ON 02/28/21 WITH COMPLAINT OF FEELING LIGHT HEADED AND HAD AN ELEVATED BLOOD PRESSURE. INSTRUCTED TO GO TO ER. WENT TO THE ER ON 02/28/21 AND BE EVALUATED CURRENTLY.

RECEIVED PFIZER COVID VACCINE DOSE ON 02/14/21 WENT TO ER ON 02/28/21 WITH COMPLAINTS OF HEADACHE SHORTNESS OF BREATH, AND 02 SAT 60% ON ROOM AIR. HAD CT HEAD WO CONTRAST THAT WAS POSITIVE FOR HEMORRHAGE AND PLAN IS TO ADMIT TO HOSPITAL

she had symptoms of a stroke; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) first dose, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Initially, it was reported that the patient experienced symptoms of Bell's palsy before getting the second dose. It was further reported that the patient stated it was not true that she experienced Bell's palsy. She mentioned she had symptoms of a stroke on an unspecified date. She wanted to confirm that her appointment for next 20Feb2021 has not been cancelled. Consumer refused to continue with the survey. The outcome of the event was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.

Completed 15 min observation; as exiting felt flush, and hot wanted to sit; sat down and slumped over; Daughter called help; No Bp or O2 measurable; felt cool and clammy to touch; chest rises with breathing; eyes open and blinking but not responding to questions asked; performed sternal rub, did not react; Rapid response notified;Connected to monitor; aganol respiration noted,Transferred to stretcher. lips turned purple; bag mask placed and bagged respirations; approx 15 chest compressions performed, responded to compressions; Started to breath and color returned to face. Immediate transfer to ED.

blood clot; death cause: Heart Problems; tired; nauseous; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL3248), via an unspecified route of administration at single dose in the left arm on 19Jan2021 14:00 for covid-19 immunisation. Medical history included heart problems, pacemaker. Concomitant medication included heparin. The patient experienced death cause: heart problems on 20Jan2021, blood clot on an unspecified date with outcome of unknown that required hospitalization, tired on 19Jan2021 with outcome of unknown, nauseous on 19Jan2021 with outcome of unknown. The patient was hospitalized for blood clot from 16Jan2021 to 18Jan2021. The patient died on 20Jan2021. An autopsy was not performed. The events were described as follows: The patient was tired and nauseous about 3 hours after her vaccine. She had been in the hospital 16Jan2021 to 18Jan2021 for a blood clot. The patient died at her home on 20Jan2021 between 4 and 7 pm. No treatment required. The vaccine was administered at Hospital Facility. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: death cause: Heart Problems

1 st dose lot EL 9262 1/25/21 2nd dose Lot EN 6201 ornENG201 --this was hand written for sure if it is a 6 or a g 2/11/2021 March 4th ER diagnosed with A Fib-----cardiovert--on eliquis twice a day and metoprolol 50 mg twice a day kept in hospital overnight-now home

Approximately 5 hours after vaccine, she started experiencing slight confusion. By morning she was completely confused, didn't know where she was, didn't know her daughter, was trying to take her medication by chewing them, couldn't speak, etc. BP extremely elevated. CT and labs all negative. Admitted to hospital. By the next morning she was more clear, but is still somewhat confused and still has memory loss.

Trouble breathing. Taken to ER. Diagnosis Congestive Heart Failure. No Previous such diagnosis. Admitted for 6 days with Metropolo benign only new prescription. After 2nd shot on February 2 had follow up visits but started experiencing light headless. On February suddenly went limp with loss of pulse and breathing. Taken to Hospital ER, admitted without neurological responses. Died on February 22.

feeling shaky/she is nervous about the palpitations.; soreness and swelling at the injection site; soreness and swelling at the injection site; she experienced palpitations when she went to bed; her arm was sore; maybe she was dehydrated; This is a spontaneous report from a contactable consumer (patient). A 81-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) , lot EL9269, expiration date 20May2021, via an unspecified route of administration on 05Feb2021 (at the age of 81 years old) as a SINGLE DOSE in the right arm for covid-19 immunisation. Medical history included ongoing High Blood Pressure Diagnosed about 35 years ago (1986) and ongoing Diabetes Type 2 Diagnosed about 20 years ago (2001). Concomitant medication included oral nifedipine from Sep2020 and ongoing at 30 mg, 1x/day for High Blood Pressure, ubidecarenone (COQ-10), bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), acetylsalicylic acid (BABY ASPIRIN) one every other day. Historical vaccine information included BNT162B2 on 15Jan2021, Lot number EL8982, Expiry 20May2021 first dose via injection into the left arm for COVID-19 immunisation at 81 years old. She had no reaction at all to the first dose. The patient's arm was sore the day of the vaccine on 05Feb2021. On 08Feb2021, she experienced palpitations when she went to bed. She got into bed and was trying to fall asleep, she started to get palpitations.She sat up and walked around, and took a acetaminophen (TYLENOL) and water, because she was thinking that maybe she was dehydrated in Feb2021 or something, and it seemed to go away, and she did fall asleep and she slept for several hours, very well. Then, around 7am this morning, the palpitations started a little again, but not as bad as last night. She had breakfast and then was okay again. Then she sat down in front of her computer, and the palpitations started again. The palpitations are not constant, they come and go. On 09Feb2021, the patient experienced feeling shaky but states this might be because she is nervous about the palpitations. On 09Feb2021, she experienced soreness and swelling at the injection site. Treatment for palpitations was acetaminophen (TYLENOL). Outcome of her arm was sore, feeling shaky/she is nervous about the palpitations, soreness and swelling at the injection site and maybe she was dehydrated was unknown. Outcome of palpitations was not recovered

1-19-21 patient fainted after ONLY having rubber band wrapped around upper right arm. After 2 doctors & several nurses failed to revive her quickly, ambulance was called & patient was taken to emergency. After venous blood draw, another blood draw was ordered because doctors were not satisfied w/results. After THREE FAILED attempts to get satisfactory arterial blood draw from one wrist, TWO MORE attempts were done to OTHER wrist! Patient had to ask for a BASIC drink of water after 5 hours of NO nursing care attention. Then...after 7 hours we had to ask for food, since this was already 5PM & patient hadn't eaten until prior evening. After NO care/attention for over 9 hours, patient & spouse left emergency room.

Chills; Involuntary jerking; Chest pounding; left arm was pulsating; chest and arm are now sore; chest and arm are now sore; Headache; This is a spontaneous report from a contactable consumer (reporting for herself). An 81-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269, expiration date: unknown), via an unspecified route of administration, administered in right arm on 11Feb2021 at 09:56 as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (lot number: EL1283, expiration date: unknown) on 21Jan2021 for COVID-19 immunization. On 11Feb2021, the patient stated getting a little headache and went to bed. On 12Feb2021, the patient got chills, stated that she started involuntary jerking that she could not control, her chest was pounding and her left arm was pulsating, going in and out. The patient also stated that her chest and arm were sore and it was pounding so hard. The patient was ready to go to the emergency room at 1:30 AM but did not. The patient was encouraged to reach out to her healthcare provider. The outcome of the event chills, involuntary jerking was recovered on 12Feb2021, chest pounding, left arm was pulsating was not recovered and unknown for the other events.

Patient received 2nd dose on 3/1 and self-reported experiencing fever and lethargy for 3 days. Two days post dose, patient complained of her left leg hurting to her daughter. Daughter inspected leg and did not notice any swelling or warmth. Two days after that symptom started (4 days post dose), patient's leg felt better but she now had shortness of breath which she claims worsened for two weeks before presenting to the hospital where patient was diagnosed with a pulmonary embolism.

The patient developed a pulmonary embolism three days after the second dose, shortness of breath, hypotension, tachycardia.

severe ulcerative colitis flare up; vomiting greater than 7 times; gray skin pallor; slightly jaundiced; This is a spontaneous report from a non-contactable nurse. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 81 years of age), dose 2 intramuscular, administered in arm right on 19Feb2021 17:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hypertension and hyperlipidaemia. The patient's concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, first dose at 81 years of age, intramuscular in the right arm on 28Jan2021 for COVID-19 immunisation. The patient was not pregnant. The patient had not received other vaccines in four weeks. The patient had no COVID prior to vaccination nor was she tested post vaccination. She had no known allergies. The patient experienced a severe ulcerative colitis flare up starting within 24 hours of the 2nd vaccine. Initially, as a exceptionally private and stubborn person, she did not report her progressing symptoms to her family and only after she "felt as if she was actively dying" did she reach out for help (01Mar2021). Additional symptoms included severe burning pain across her lower abdomen, vomiting greater than 7 times, persistent diarrhea, gray skin pallor and she appeared slightly jaundiced. Patient refused repeated offers from daughters to be taken to hospital. On 01Mar2021, contact was made with her gastroenterologist and in the morning of 02Mar2021, she was restarted on her UC treatment, which was oral budesonide (unsure of dose). Outcome was improving. She was now able to intake food and liquids and her UC symptoms are resolving. She was up and active again. The events started on 20Feb2021 with outcome of recovering. Therapeutic measures were taken as a result of the events. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Based on data provided and temporal association, the reported events are assessed as possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Came to the emergency room. she woke up from the sleep, she was noticing increased secretions, she was short of breath and was wheezing. She called EMS, when EMS came her pulse ox was 56%, she was placed on CPAP and oxygen, pulse ox went up to 82%. Patient was placed on BiPAP in the emergency room Severe mitral regurgitation, class IV CHF symptoms despite medical therapy for her volume overload. Was transferred to larger hospital due to severity

Frequent arrhythmias; 20 point systolic BP rise; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue; audible pulse in ears; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6200), via an unspecified route of administration administered in left arm on 19Feb2021 18:00 (at the age of 81-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The reported facility type was a hospital. No other vaccine in four weeks. The patient did not have covid prior vaccination and was not covid tested post vaccination. Medical history included Hashimotos Thyroiditis, irritable bowel syndrome (IBS), food and seasonal allergies, allergies Iodine isotope contrast, latex, cows milk protein. Concomitant medications included levothyroxine sodium (SYNTHROID); amlodipine and spironolactone. The patient previously took paracetamol (TYLENOL) and thiomersal and experienced allergies from these drugs. The patient experienced frequent arrhythmias day after; several days of 20 point systolic BP rise; audible pulse in ears; sense of danger; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue all on 20Feb2021 at 13:00. After 20 days (in Mar2021), all has abated but muscle weakness and fatigue. Unwilling to risk the booster. There was no treatment for the events. The outcome of the events muscular weakness and fatigue was not recovered while for the remaining events was recovered with sequelae in Mar2021.

"widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; Cardiogenic shock; Anterior myocardial infarction; This is a spontaneous report from a contactable consumer. An 81-years-old female patient received BNT162B2, dose 2 via an unspecified route of administration, administered in left arm on 06Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included very sensitive to medication effects (usually takes only 1/2 dose with strong efficacy to avoid side effects). Breast cancer survivor (2014 onset, 2019 declared permanent remission) and mild blood pressure treated successfully with medication for about 10 years. Concomitant medications included spironolactone and valsartan, both taken for blood pressure. The patient previously received first dose of BNT162B2 on 16Jan2021 in left arm for COVID-19 immunization. The reporter's mother died 3 weeks and 6 days after having received the second dose of the Pfizer covid vaccine. The cause of death was a "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; the event began about 11:45pm on 04Mar2021. The blockage was confirmed via cardiac cath procedure performed within 2 hours of the onset by Doctor, he removed the clot and placed a stent. However her heart was too damaged and could not recover. Doctor confirmed to us that she did not have excessive or evidence of any prior blockage and not excessive plaque. The blood clot likely came on and caused the cardiac event within roughly an hour, he explained. The patient had no prior symptoms and no comorbidities for blood clotting and was full of life and energy on 05Mar up to when she went to bed that night. She died 06Mar at 4:04 am at hospital. The strat date of the events was reported as 04Mar2021 at 11:45 PM. AE resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient died on 06Mar2021. An autopsy was not performed. The death cause: Triggered by the sudden 100% blockage of the LAD by a blood clot, the cause of death is listed as (A) Cardiogenic shock (B) Anterior myocardial infarction. Treatment was received for the events which included multiple resuscitations and angioplasty surgery. No covid prior vaccination, no covid tested post vaccination. The outcome of the events was fatal. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; "widow maker" type heart attack where the LAD artery suddenly became 100% blocked by a blood clot; "widow maker" type heart attack where the LAD artery

Patient presented and was admitted through the ED for complaint of epigastric abdominal pain onset this morning that has since resolved, as well as complaint of shortness of breath, fatigue that is persistent. She had HD but stopped 10-15 minutes into HD with noted severe bradycardia. Diagnosis on admission - 3rd degree heart block. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine.

After the nurse said old gee and kept wiping my arm; It went up to about 180, 190 even 200 over 80; The test results shows that I have no antibodies; Anxiety; This is a spontaneous report received from a contactable consumer for herself. The consumer reported the similar events for the patient with different dose. This is the second of two reports. This 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT: EL9266), via an unspecified route of administration administered in left arm on 26Feb2021 as single dose for COVID-19 immunization. Medical history included cholesterol. The patient was taking medication for her cholesterol. The patient received the first dos of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9264) on 26Feb2021 in left arm for COVID-19 immunization and after the first dose about 8 days later, her blood pressure went up very high. Its normally never get that high. It went up to about 180, 190 even 200 over 80 and then she saw her physician was put on some blood pressure medication, and she got better. When the patient received the first dose, she have a headache and was slightly nauseous. Then the patient had her second vaccine. After that the same thing happen about a week later. her blood pressure went very high (went up to about 180, 190 even 200 over 80), and she suffered because of it with a lot of anxiety in 2021. The patient want to know something about that the blood pressure went really very high. It was still not regular; it was very irregular. When she went for the second dose, she did not even looked when the nurse was putting a needle in her arm so, she felt that the needle went in but shortly after she heard the nurse said oh jeez and she know the nurse put it right in her arm. Shortly after the nurse said old gee and kept wiping her arm. Later she noticed the nurse had a gauze under the band aid. The patient thought maybe she was bleeding, she did not have a look, she ended up with a bandage over it and that was it, other day she see it did not have any blood on it. And she wondering if she got the full dose of the second vaccine, she had absolutely no side effects immediately after over the next day. Also, she took a test for antibody and that came out negative in 2021. She was still experiencing the high blood pressure after the second vaccination as well. The physician had prescribed the medication for blood pressure went very high with losartan 75 mg. The outcome of blood pressure went very high was not recovered. It's over. It's between a 140-150. The outcome of other events was unknown. No follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299032 same patient/drug, different dose/event

passed out; dizzy spell; fell down; have gotten shorter/ shrunk; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6203), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. Medical history included high blood pressure, diabetes, thyroid disorder, and bleeding. The patient stated "I am bleeder. My father had hemophilia and I have the female version which I never remember what it's called but I bleed easily but I didn't bleed at all for when I had the shot, it was fine." Concomitant medication included levothyroxine sodium (SYNTHROID). Patient stated, "Yes, I took my medication that morning. I take thyroid medication, blood pressure medication. I don't remember what I take for blood pressure." The patient reported "Well I am calling I felt just fine right now. I had my first shot by Pfizer on the 24th and I felt great and they watched me and I left and I was driving home and I had a dizzy spell while I was driving. I don't know if I passed out or not, I might have but if I did, it wasn't for very long, they were digging up the road I couldn't stop, couldn't park so I made it home okay and I was fine the rest of the day but then the next day, I had a lot of dizzy spells but I was at home so I didn't worry, I just sat down and I was okay and then the 3rd day I got up for breakfast and I bumped into everything, I dropped everything and then I started to get out of chair and the chair fell down and I fell down and that was just a mess. So, I went to bed and I felt at least if I fall, I fall on bed and that was the day I was dizzy but then it went away and I have been fine ever since. That began on 24th, the 24th was the first day and I did call my doctor and I have been trying to call here and I never think it through but finally today, sat to watch, hang on to the phone and what I am concerned about is getting my second vaccine. Is there anything I should watch for or tell anybody or, because my doctor said you shouldn't get dizzy but I did?" The patient confirmed the vaccine as Pfizer's Covid 19 vaccine. About the lot number, the patient stated, "It looks like EN, I am not sure if it's E and N 6203." The patient further reported, "No, I just went home and the first day I was over with it by the time I got home and I didn't had anymore. The next day I just sat down and rested, I knew it will go away and it did and then 3rd day I went to bed and just thought I would fall and hurt myself and that's everything I did. Well I used to be 5 foot 2 and a quarter but I think I have gotten shorter, I don't know what I really am but little bit shorter than that now and my weight is 100 and lets see, I am going to say 170, I don't think that's exactly right but it's pretty close to that I think, I didn't really weighed myself lately. 5 foot 2 and a quarter that's what I was when I did last but now I shrunk and less than that but I don't remember what I am." The outcome of the events was unknown.

Clot; Swelling and pain in left foot, ankle, and calf; Swelling and pain in left foot, ankle, and calf; This is a spontaneous report received from a contactable consumer (Patient's son). A 81-years-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number not reported), via an unspecified route of administration, administered in Arm Left on 02Feb2021 (believes in afternoon) at single dose for covid-19 immunisation. The patient medical history and concomitant medication were not reported. Patient previously took history vaccine included shingles shot received on Nov2020 and Flu shot typically gets every year. On 02Jan2021, patient received first dose of COVID vaccine (BNT162B2) for covid-19 immunisation. The patient experienced severe swelling and pain in foot, calf, and ankle on the left side shortly after the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered. She was hospitalized and placed on Xarelto for treatment by her cardiologist and was scheduled to follow-up to have other procedures performed as deemed needed. Doctor advised patient had a clot and was put on Xarelto. An angio and cath was suggested to see if she had something closing up in her. Patient was going back in a few weeks to see about the clot. she never had this clotting concern before, and this was all new right after the second COVID vaccine. Swelling and pain in left foot, ankle, and calf was either 04Feb2021 or 05Feb2021. she first noticed left foot was swollen. she stated her foot was sore. It was unknown if it went to her ankle and then from there. It was stated that the pain and swelling was better. She was informed by the nurse administering the COVID vaccine that second dose would be a little bit stronger. The patient underwent lab tests and procedures which included MRI on 15Feb2021 and diagnosed the clot. The outcome of the event Clot was unknown. For other events was recovered on unspecified date in 2021. Information about Batch/Lot number has been requested.

fluid in lungs; difficulty breathing; congestive heart failure; AFib; The initial was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 19Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that an 81-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9263), via an unspecified route of administration on 29Jan2021 15:00 at single dose for COVID-19 immunisation. Medical history included diabetes from 1991 and ongoing. Concomitant medications included insulin taken for diabetes, lisinopril, lovastatin, omeprazole (PRILOSEC), and piroxicam (PAXIL); all ongoing. The patient received first dose of bnt162b2 on 08Jan2021 for COVID-19 immunisation and experienced sugar out of control. On 29Jan2021, the patient experienced fluid in lungs, difficulty breathing, congestive heart failure and AFib (Atrial fibrillation). The events required a visit to the emergency room. The patient was hospitalized on an unspecified date for 5 days. The events required initiation of new medication/other treatment and procedure and many tests. The patient underwent x-rays on an unspecified date and showed fluid in lung. The patient had no other vaccinations within four weeks prior to the vaccine. Outcome of events was not recovered.

Swelling of vocal chords followed by need to blow nose which caused bleeding and clotting in nostrils.; Swelling of vocal chords followed by need to blow nose; Swelling of vocal chords followed by need to blow nose which caused bleeding and clotting in nostrils.; Causes constant congestion.; crusted scabs from nose for over two week timeframe.; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number; EL9264), via an unspecified route of administration administered in left arm on 09Feb2021 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no COVID prior to vaccination. Medical history included osteoarthritis, osteoporosis, neuropathy, hypothyroidism, thyroidectomy, hysterectomy, and two recent falls. The patient had no known allergies. Concomitant medication included influenza vaccine (FLU) taken for immunisation. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249) on 19Jan2021 at 04:30 PM administered in the right arm for COVID-19 immunization. The patient experienced swelling of vocal chords followed by need to blow nose which caused bleeding and clotting in nostrils. The patient was constantly blowing up bloody clots/crusted scabs from nose for over two week timeframe. At first, was a lot of clots, red blood and scabs. It got better over 14 days, but, still persists. Now clots and scabs are smaller but still frequent. Causes constant congestion. All events started on 05Mar2021 at 12:00 AM. The events resulted in doctor or healthcare professional visit/clinic visit. There was no treatment received for all events. The patient was COVID tested (nasal swab) post vaccination on 09Mar2021 which was negative. The patient had not yet recovered from all events.

she was hospitalized due to a stroke; This is a spontaneous report from a contactable nurse (patient herself). An 81-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in arm at age 81 years on 24Feb2021 (Batch/Lot Number: EN6201) as single dose for COVID-19 vaccination. Medical history was reported as none. Patient had not had any other recent vaccinations. The concomitant medication includes an unspecified medication since she started a new cancer drug that starts with a L.Registered nurse calling as patient says she was supposed to have her second Pfizer COVID-19 shot 17Mar2021, but she was in the hospital. She says she is trying to reschedule her second shot. She says the first dose was given at (Hospital Name), and it says BNOI on her vaccine card. Patient was admitted to the hospital this past Monday evening (15Mar2021) and it was (Hospital name). She says her admitting diagnosis was unknown. She says she was discharged from the hospital Thursday 18Mar2021. Hospitalization seriousness patient says it was not serious. Patient missed the 2nd dose (17Mar2021) because she was hospitalized due to a stroke on an unspecified date. The outcome of the event was unknown.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of stroke. The reported event likely represent intercurrent medical condition in this elderly patient. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. 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.

break in rash/rash in mouth and throat; sore throat; dizzy; weak; felt like sleeping all the time; pain in her arm; blood clot in right leg; couldn't walk; veins are swollen; right knee got swollen; ear ache; felt like burning/ sore in her mouth like she was burned; sore in her mouth like she was burned; nausea; headache; slight fever; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in right arm on 09Mar2021 (Lot Number: EL9266) at single dose for covid-19 immunization. Medical history included arthritis, respiratory issues, allergies, Eczema of the nipples and breast, arthroscopic surgeries, she lost her voice. Caller stated she exercised everyday, she did yoga. Caller reported the last 2 years she hadn't been able to climb the mountain on the stairs. Caller states she didn't catch a cold, she was fine, she was very active. She was good except arthritic conditions, she has had arthroscopic surgeries, that was a side effect of that. Caller reporting she was a first responder and had some respiratory issues. Caller stated she had some allergies, if with dust or smoke, her throat constricts, it was just small, like her throat. She cannot be around that. She got once in a while, when she got in a rush. Caller stated before the vaccine, she had eczema in her nipples, on her breast. Caller stated she never got sick, besides the rash she got once in a while. Caller states but she was very healthy otherwise, no medication, no smoking, no drinking. Caller stated she was from 9/11, this was what happened with her voice once in a while, she lost her voice. Caller stated she had had some respiratory issues and allergies and so on. Caller stated she was here for 56 years and her mother died of old age so she was not sure. There were no concomitant medications. The patient previously took advil. Caller stated she used to take Advil when she went to the gym and had problems but she hasn't taken Advil for a while. She didn't take meds. Caller stated she didn't drink or smoke because what it did was it gave you a release. Caller stated she was not taking none, she was pushing through and hoping it will heal itself. The patient experienced blood clot in right leg on 26Mar2021, break in rash on an unspecified date, headache on 09Mar2021, slight fever on 09Mar2021, veins are swollen on 12Mar2021, right knee got swollen on 12Mar2021, sore throat on an unspecified date, ear ache on 10Mar2021, nausea on 09Mar2021, rash in mouth and throat on an unspecified date, felt like burning/ sore in her mouth like she was burned on 10Mar2021, sore in her mouth like she was burned on 10Mar2021, dizzy on an unspecified date, weak on an unspecified date, felt like sleeping all the time on an unspecified date, couldn't walk on 12Mar2021, pain in her arm on an unspecified date. Was a first responder, sometimes break in rash once in a while. Got Pfizer 1st vaccine 09Mar, was scared to have difficulty breathing however had headache, slight fever, right knee and veins were swollen, sore throat, ear ache, nausea, rash in mouth and throat also felt like burning also was dizzy and weak and felt like sleeping all the time. Caller stated she was told by her doctor to take the shot on 09Mar2021. Caller stated she had headache, slight fever, then her head was ok the fever was gone but the headache persisted as of today. Caller stated she still had headache and ear ache and her knee got swollen, her right knee. Caller stated for a few days she couldn't walk. Caller reported she has arthritic conditions in knees, she exercises everyday and no problem, but she couldn't walk for a few days. Caller states now she is able to walk on something, but the veins in the knee were still there and she didn't know. Caller stated she was due for second next on Tuesday and she was wondering what to do. Caller stated she was honestly worried about this reaction after the first shot. Caller stated she was told the 2nd had a worse reaction, so she was really weary and worried. Caller stated she only slept 5 hours at night, but now she wanted to sleep all the time. Caller stated she had such a headache and earache. Caller stated it made her nauseous, like in a sea or something. She stated she didn't know how to explain. She didn't vomit like when you were nauseous, it wasn't that feeling. Caller stated it was just lingering like when you were in the ocean. Caller reported headache has gotten better. It has gotten worse and then gotten better. Caller stated the earache was so painful and was still there. Caller reported she got it during the day and when she lied down, but the severity had subsided. Caller stated she didn't measure fever. She wanted to say after that, her mouth was sore after fever from the heat or from the vaccination. Caller stated her mouth was still today, still sensitive. Caller reported it was like her throat and her mouth was so sore like a burn. Caller reported her headache was mostly on the left side, but went to the right side too. Caller reported she could feel it in her eye, it hurt and her ear hurt. Caller reported her sore throat, the upper part, was still sensitive. Caller stated she couldn't swallow, but it was clear, her mouth was clear, only the upper top she would say. Caller stated it's 99% gone, its healing. Nauseous, like in a sea, its not like she has it all day long- nauseous- maybe once a day, nothing severely like what she had for a few things. The patient had a pain in her arm and she had that symptom one night and the following day she had nothing. Her arm was cooperative. Since she had been diagnosed with a blood clot. She saw her doctor on Friday and was recommended that she took some medications. She continued to have headache which she reported, though not as bad. She also reported that she had a sore mouth and earache. She was still fighting symptoms and didn't know what to do with the blood clot. She was scared to take the blood thinner Eliquis and that she will have side effects that it will do her harm she felt Eliquis will do her harm if she received the second dose of the vaccine or takes Eliquis. She was supposed to 20mg daily which she felt will kill her given her body was not healed from receiving the first dose of the Covid-19 vaccine. There was no prior vaccinations within 4 weeks. She was prescribed Eliquis Film-coated tablet (Lot Number: ABN4449S, Expiry date: Feb2023) 20mg daily for blood clot but had not started because she felt it will kill her was scared to take the second dose of the vaccine. The patient underwent lab tests and procedures which included Sonogram: blood clot in right on 26Mar2021. Therapeutic measures were taken as a result of blood clot in right leg. There was Physician Office Visit for all events. The outcome of the event blood clot in right leg, veins are swollen, right knee got swollen, couldn't walk was not recovered, of event slight fever was recovered on 10Mar2021, pain in her arm was recovered, of event ear ache, nausea, felt like burning/ sore in her mouth like she was burned, sore in her mouth like she was burned was recovering, of other events was unknown.

her blood pressure was off/her blood pressure was off, she clarifies it was high; thyroid was off; she went to the hospital ER for A fib (Atrial fibrillation); funny feeling; she is nervous to go out; This is a spontaneous report from a contactable pharmacist (patient). A 81-year-old female patient received second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunisation. Patient's medical history included stroke (She did have a problem 2 years ago, she had a stroke but other than that she has been active). Patient had historical vaccine at 81-year-old BNT162B2 on 25Jan2021 lot number EL9262 for Coronavirus immunisation. There were no concomitant medications. The patient experienced she went to the hospital ER for a fib on 04Mar2021, her blood pressure was off/her blood pressure was off, she clarifies it was high (hypertension), thyroid was off, funny feeling, she is nervous to go out. She said the second dose was 11Feb2021 and she first noticed the atrial fib 04Mar2021, she went into the hospital 04Mar2021 and was discharged 05Mar2021. The patient underwent lab tests and procedures which included blood pressure was up and blood pressure was off on an unspecified date. When probed for causality reporter states, it could be related but she is not sure because she just cant understand how everything, her thyroid, her blood pressure went up, way up, and her heart. She really doesn't know, she thinks it is pretty serious, she is nervous to go out. She confirms it was requiring hospitalization, they kept her, the cardiovert was that afternoon and they kept her until next morning. The outcome of event was unknown. Information related to lot/batch number was requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events atrial fibrillation, hypertension, and thyroid disorder and the suspect drug. 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.

Jan 13 first dose received...Jan 30th collapsed at night by herself. Was able to get up and go back to bed. Next day was taken to urgent care and sent by emergency to hospital. Suffered large blood clot in the leg that broke off and traveled to the lungs. Acute saddle pulmonary embolism with acute cor polmonale. Was put on blood thinners and released from hospital on 2/2. As soon as we got home from the hospital she suffered from a massive gastrointestinal intestinal bleed and had to be rushed back to the hospital. Two days later while still in the hospital she suffered a mild heart attack and had a stent inserted.

Pt was diagnosed with cerebral venous sinus thrombosis on 3/25/21 after having severe HA x 3 days. Looing back, she had a cbc for other reasons on 2/24/21 (3 days after her 2nd Covid vaccine) that showed a drop in platelets to 126,000 (although platelets in 2020 were 150,000)

Patient diagnosed with COVID-19 infection on 3/31/21, chest xray at that time unremarkable. Patient presented to outlying hospital on 4/4/21 with worsening cough and nausea. D-dimers were elevated and CT chest showed scattered airspace opacities. Prescriptions for antibiotics and patient discharged from ED. Patient again presented to outlying ED on 4/6/21 with worsening shortness of breath and nausea and poor appetite. Patient was hypoxic saturating 86% on room air and was requiring 3L to maintain oxygen saturation. Repeat chest x-ray showed mild-to-moderate bilateral airspace opacities. Patient was admitted to outlying hospital on 4/6/21. Patient transferred to this hospital on 4/9/21 with severe diffuse bilateral pulmonary infiltrates on CT chest and worsening COVID-19 infection. Patient was treated with oxygen, antibiotics, remdesivir, and steroids. Patient was discharged to home with new home oxygen.

Shock; Reduced Central pulse volume; Loss of consciousness; potential anaphylactic reaction; found unresponsive in a swimming pool; This is a spontaneous report received from a contactable Physician. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included cardiac arrest, congestive heart failure, difficult breathing and arrhythmia. Concomitant medications included metoprolol; omeprazole; propranolol; duloxetine; fosinopril; pravastatin; hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ); levothyroxine sodium (SYNTHROID); insulin glargine (BASAGLAR); asa and ranitidine hydrochloride (ZANTAC). The patient previously minocycline for swelling and the patient had a historical vaccine of shingrix on 11May2020. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Jan2021 for covid-19 immunisation. The reporter stated that the patient was found unresponsive in a swimming pool on 18Feb2021. The patient also experienced shock, reduced central pulse volume and loss of consciousness and potential anaphylactic reaction on an unspecified date. The patient did not received any recent vaccines for SARS-CoV2 other than Pfizer_BioNtech COVID-19 Vaccine prior to the event being reported. The patient died on 22Feb2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. Information on Lot/Batch number has been requested.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: found unresponsive in a swimming pool; Shock; Reduced Central pulse volume; Loss of consciousness; potential anaphylactic reaction

Stroke involving paralysis of right arm, right leg, slurred speech, facial droop, nausea, garbled speech

3.30.21 Family brought pt to ED because right nephrostomy tube (that had just been replaced 3/26) was not draining. She was admitted to the hospital on 3/30/2021 with fatigue and concern for malfunction of recently exchanged NT which are in place for ureteric dysfunction. Found to be COVID positive on arrival to ED. Discharge Diagnosis and Associated Hospital Course Ureteric Dysfunction Bilateral Nephrostomy Tubes in place Possible UTI - H/o bilateral nephrostomy tube placement secondary to ureteric dysfunction secondary to pyelonephritis with stents in place - Last nephrostomy tubes were placed on Saturday, 3/27/21 per in VIR; since that time her right nephrostomy tube was not draining and pt has noted increased fatigue so presented for evaluation - CT Kidney Stone: Bilateral percutaneous nephrostomy tubes, appear appropriately positioned without obvious complication. No hydronephrosis or urolithiasis. Nonspecific thickened appearance of the rectosigmoid colon without adjacent stranding - VIR followed for NT tube check however tube started draining urine so no need for check - Urine cx with GNB so treating with keflex on dc COVID-19 Virus Infection - Date of symptom onset: 3/30/21 (isolation to end 4/8/21) - Symptoms: Fatigue - Date of positive COVID-19 test: 3/30/21 - Location of positive COVID-19 test: ED - Oxygen status: None - PT/OT consults indicated : yes - Case Management/Social Services consulted: yes - DVT prophylaxis: Lovenox - Decadron: NO - Remdesivir: NO

8 days after the 2nd Pfizer shot sudden vomiting including blood and then collapse and died. No other symptoms of sickness leading up to this.

heart arrhythmia; cardiac arrest; This is a spontaneous report from a contactable consumer who reported for his wife. An 81-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number EM9810) via unspecified route of administration on 02Feb2021 (at the age of 81-year old) at single dose for COVID-19 immunization. Relevant medical history was not reported. Concomitant medication included metoprolol from Jan2021 for congestive heart failure. The patient received the first dose of the same vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number) on 12Jan2021 and on 15Jan2021, she had such trouble breathing diagnosed in the Urgent care as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. On 18Feb2021 she collapsed, went limp and went into the hospital and she was neurologically unresponsive. They tried to revive her and did bring her back with 5 epi shots, he was told that they did bring her back. When she got to the ER she went pulseless again and they gave her two more epi shots and got her back but she never did come out of a coma-like state. They admitted her to ICU. She stayed there until she passed away on the 22Feb2021. CT scans, X-rays, images of her heart, echocardiograms were performed. She was tested for COVID in Feb2021 and it was negative. They did a brain scan and there was no activity because she had been too long without oxygen. The consumer reported that the week before the cardiac arrest, she was feeling faint but she never passed out. Death certificate stated cause of death was heart arrhythmia and cardiac arrest. No autopsy was done.; Reported Cause(s) of Death: heart arrhythmia; cardiac arrest

This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose for COVID-19 immunisation on 13Jan2021. Relevant history included mild dementia, high cholesterol. Relevant concomitant drugs included memantine 10MG,donepezil 5MG,atorvastatin, cetirizine hydrochloride (ZYRTEC). The patient was not pregnant. No known allergies. On 30Jan2021, the patient fell and became unconscious after getting up from bed to use bathroom, was able to get up and go back to bed. Next day, 31Jan2021, she told her daughter at 2pm what had happened and daughter took her to urgent care. Urgent care was performed EKG and called ambulance as EKG suggested suspicious activity. She was coughing with blood. Cat scan of the lung revealed acute saddle pulmonary embolism with acute cor pulmonale and a large blood clot in the calf. On 02Feb201 then placed her on blood thinner and discharged her. As soon as arrived home, she began to suffer a massive gastro intestinal bleed and was rushed back to the hospital. On 04Feb2021, she began to have heart issues and suffered a mild heart attack and underwent a procedure to have a stent inserted. She developed the shingles the next day (05Feb2021). The events assessed as serious due to Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient visited Emergency room/department or urgent care. The outcome of events was resolved with sequel. Treatment therapy involved. The patient was not diagnosed with COVID prior vaccination. The patient had Nasal Swab/Fast Test/PCR (for COVID) in Apr2021 with negative result. Information on the lot/batch number has been requested.

Presented with fall and worsening shortness of breath, clinical impression that hypoxia secondary to HFpEF rather than COVID infection. Patchy infiltrates on Chest CT- Rx with dexamethasone.

4/22/21 Patient presented to ED for evaluation of chest pain and shortness of breath of several weeks of evolution. Of note, patient had covid infection at the end of Dec 2020 - beginning of Jan 2021 and had pfizer vaccine, 2nd dose in mid march. Per patient she has been complaining of progressive SOB for the last 2 months. Denies recent travels or trauma. CTA in ED revealed bilateral Pulmonary embolisms and suggested possible right Heart Strain.

After 2nd Vaccine on 3/6/21, she became ill on 3/8/21, fever and chills was in bed all day on 3/9/21 with the same symptoms. Woke up on 3/9/21 with shingles, Her PCP was treating her with Famciclovir and Gabapentin for pain. She no longer had the fever or chills but still didn't feel well. On 3/17/21 she was admitted at Medical Center which she was treated for a blood clot in her lung and for pericardial effusion. She was put on blood thinners which then caused a bleed in her hip bone. She had a surgery to put a filter in to stop more blood clots and to drain the fluid from her heart. She died on 3/27/21 around 3:30pm.

3/6 I woke up with a nerve pain the size of a silver dollar at top center of right thigh where it joins my torso and i still have that pain, 3/9 under distress because of the pain I had a venous ultrasound on both legs with Dr., then I noticed on 3/13 rose pink flesh on both lower calves, 3/18 Dr sent me for an MRI Imaging of my lower back because of the pain. 3/19 I saw Neuro Dr for Botox on left side of face, I was told that they thought a nerve crossed a vein that caused a tremor on the left side of my face. 3/23 Dr. had an audio apt. 3/29 I had a full breakout of cellulitis on my lower left leg and it was a deep deep purple red and it itches. 3/30 I was sent to Dr assistant to see if I had extensive back and hip trouble and I was examined physically with movement, they offered a shot at nerve point and water therapy. I put arnicare on the spot and it makes the pain manageable. 4/7 cellulitis, 4/9 I tried to be seen, 4/10 my heart beat irregular, then the rash appear and there was acute pain at the top of my head. ValACYcalovir 500 tab (valtrex) 4/19 Sonogram for arteries in my legs and I was given the doxycycline and prednisone, and today I still have a bright red and swollen ankle on the right and I still have some dried up shingles on my chin and head. I have photos that I took of my reaction to the vaccine.

Patient presented to ED on 4/5/2021 with 3 day history of dyspnea and productive cough. Patient was hypoxic at 76% on room air at doctor's office prior to presentation at ED. Patient had a known COVID-19 exposure (daughter) in past 1-2 weeks. Patient tested positive for COVID 19 on 4/5/21. Patient was treated with oxygen, antibiotics, steroids, remdesevir, and convalescent plasma. Patient underwent CTS chest to rule our PE--this study was negative for PE. Patient improved and was discharged to home with new oxygen therapy.

shortness of breath; congestive heart failure; fainting; dizziness; This is a spontaneous report from a contactable consumer. An 81-year-old female patient (consumer's wife) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number:EJ1289), dose 1 via an unspecified route of administration on 12Jan2021 as SINGLE DOSE (at the age of 81 years-old) for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included metoprolol taken for congestive heart failure from Jan2021 to 2021 and unspecified medication. The patient experienced shortness of breath, congestive heart failure, fainting and dizziness on 15Jan2021. The patient was hospitalized for shortness of breath from 15Jan2021 to Jan2021. On 15Jan2021, she had such trouble breathing that he had to take her to urgent Care. Urgent care diagnosed it as congestive heart failure with enlarged heart and fluid in her lungs because of her heart being enlarged. She had not had any previous heart problems. Then states there may have been some earlier but it did not rise to the level of being noticed. The urgent care said she should be admitted to the hospital and to go the emergency room. Urgent Care told the consumer that they thought it was important to admit her as soon as possible. The patient was hospitalized for congestive heart failure from Jan2021 to Jan2021 for 5 or 6 days. The patient underwent lab tests and procedures which included computerised tomogram: unknown result in 2021, computerised tomogram: images of the heart: unknown result in 2021, transesophageal echocardiogram: unknown result in 2021, echocardiogram: unknown result in 2021, magnetic resonance imaging brain scan: no activity in 2021, sars-cov-2 test: negative in Feb2021 and x-ray: unknown result in 2021. Therapeutic measures taken as a result of congestive heart failure included metoprolol from Jan2021 to 2021 and furosemide (LASIX) to get the fluid out and once the fluid was out they did a transesophageal echocardiography (TEE). The patient was told to follow up with the cardiologist and the regular general practitioner (GP) and things seemed to be going ok. They advised her to get the second COVID shot and she got it. The second dose of COVID Vaccine was on 02Feb2021, Lot: EM9810, NDC and Expiration unknown. The events shortness of breath, congestive heart failure required an emergency room visit. The clinical outcome of the events shortness of breath, congestive heart failure, fainting and dizziness was unknown.

Blood clot in lungs and leg; Trouble breathing/Shortness of breath, but not as bad; didn't feel right; Chest tightness; Slightly ill; Sore arm, in left arm where the shot was; Slightly tired; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 10Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunization. Medical history included Type 2 Diabetes from 2004 and ongoing, High Blood Pressure from 2000 and ongoing (reporter stated she was 81; it's not very high, usually when she goes to the doctor). Concomitant medications not specified but reporter mentioned that everything she has been on she has been on long time; she takes blood pressure medication because sometimes it is high. She has not had started any new medication prior to starting vaccines or during both vaccines. The patient previously received flu shot (September). The patient received her first vaccine dose of bnt162b2 (Lot # EL9262, Expiry date UNKNOWN), on 20Jan2021, at 1:30-1:45, in the left arm and experienced sore arm and slightly tired. The reporter stated that after her second vaccine on 10Feb2021, she had a sore arm, (left, where shot was) and was slightly tired from 10Feb2021 until 12Feb2021. She confirmed she noticed this started the same day, 10Feb2021. On 31Mar2021, she felt slightly ill and had some slightly trouble breathing. She saw her doctor who did some tests. The next day 01Apr2021, her tests came back and the doctor told her to go to the hospital. While in the emergency room she had a CT of the lungs that showed blood clots in both lungs. She was admitted to the hospital where on 02Apr2021 they did a ultrasound of her legs. She was told she had blood clots in her right leg. She stated she had no symptoms of blood clots in her legs like redness, sore, swelling, or hot. She was asked if she had fallen suddenly, had an accident, or was sitting for a long time, traveled a long distances. On 02Apr2021 she had a Echocardiogram and was told her heart was ok. Caller stated she was given Lovenox shots in the hospital. She did not have Lot # or Expiry date on the Lovenox. She stated on 02Apr2021 after having two Lovenox shots that day, she met with a Vascular Surgeon who started her on Eliquis that evening. She stated she started taking Eliquis that evening. She stated she took 2 tablets, twice a day, for a week. Now she takes one tablet, twice a day, ongoing. The Eliquis tablet says 5mg. She stated she was discharged on 03Apr2021, that evening. Patient went back to the emergency room on 10Apr2021 after speaking with a nurse at (university name withheld) because she had tightness in the chest but the shortness of breath, her breathing was not as bad. She just didn't felt right. She stated she was not admitted. Patient stated she saw a NP (name withheld) with (university name withheld) Pulmonary the day of 31Mar2021. When discussing the tests performed that day, Chest X-ray, D-Dimer, and Pro INT, CH asked caller the results from them. She did not provide results, just stated she had looked up her results in "EPIC mychart" while getting the result information from the office. Where she was instructed to go to the hospital. She went to the Clinic of the Vascular Surgeon at (Hospital withheld) on Wednesday 14Apr2021 and was feeling better. Her second appointment with them will be in July. Where they will do another ultrasound of her legs and talk about the medication. She has an appointment with her primary on 19Apr2021. The outcome of events Trouble breathing (recovered on 14Apr2021), Shortness of breath, but not as bad (recovered on 12Apr2021), Sore arm, in left arm where the shot was (recovered on 12Feb2021), Slightly tired (recovered on 12Feb2021) Chest tightness (recovered on 12Apr2021), and didn't feel right was recovered. The outcome of event Blood clot in lungs and leg was unknown.

6 days following vaccine patient had blurred vision and collapsed; refused transport to hospital from EMS; 10 days after vaccine, patient suffered what was deemed to be a TIA but actually found to be an ischemic stroke. Was speaking and was to be released to at home rehab; 1.5 days later suffered what appeared to be a stroke but brain MRI showed no change. She now has C3 nerve involvement not related to the stroke and, speech and movement issues. Cause undetermined.

Deep vein thrombosis leg; This is a spontaneous report from a contactable consumer, based on information received by Pfizer. This case is split from master case for a 81 year old patient taking BNT162B2 and experienced Deep vein thrombosis leg. This is a spontaneous report from a contactable consumer. An 81-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included exposed to toxins from 911, patient stated that she is 911 survivor. The patient's concomitant medications were not reported. The patient experienced deep vein thrombosis leg on an unspecified date. The event outcome was unknown.

I21.4 - Non-ST elevation (NSTEMI) myocardial infarction E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified

ears went dead with no sound to be heard, went to walk felt like could not control body, was swaying all over the place, and really sick. sick to stomach when stroke started happening, weaknesses everywhere could not stand up or get up in bed. Started throwing bike up really bad , dizziness happening, spilled out both ends of body, speech little slurred, stroke was happening. Got to hospital still felt dizzy for at least 3 days, throwing up lasted several hours. Zoned out in hospital for awhile but not while stroke was happening, in intensive care for 2 full days, in hospital for 3 days then transferred to rehab in hospital. Left side was affected both arm and leg and slurry speech. Little weakness in right arm. Home from rehab 2 weeks later. Still having issues with leg.

ED to Hosp-Admission Discharged 4/6/2021 - 4/9/2021 (3 days) Last attending ? Treatment team Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) Principal problem Discharge Summary Internal Medicine Discharge Summary Hospitalist Medicine Admission Date: 4/6/2021 Length of Stay: 3 Days Discharge Date: 4/9/2021 Admission Diagnosis Hospital Problems POA * (Principal) Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) Yes Type 2 diabetes mellitus (CMS/HCC) Yes Obesity Yes Hypothyroidism Yes Chronic combined systolic and diastolic heart failure (CMS/HCC) Yes Benign essential hypertension Yes 81-year-old female presented to the hospital with a complaint of fever and cough COVID-19 - now saturating well on room air and Afebrile Complaining of sore throat and difficulty in swallowing- now resolving Back pain improving Episode of diaphoresis and blurry vision -now resolved Home Or Self Care CODE STATUS: DNR (Do Not Resuscitate) Active Issues Requiring Follow-up Follow-up with PCP for further care as outpatient. Test Results Pending at Discharge Pending Labs Order Current Status Blood culture- 2 SETS Preliminary result Blood culture- 2 SETS Preliminary result Hospital Course HPI: See H&P Hospital Course: Patient presented to the hospital with a complaint of fever and cough. She was admitted for COVID-19 with respiratory failure. Since she was saturating below 94%, she was started on remdesivir on admission. Oxygen was given for supportive care. She received albuterol inhaler, Mucinex, Tessalon Perles and Decadron. In addition she complained of some sore throat and received Chloraseptic spray along with lozenges. She had an episode of diaphoresis and change in vision during the hospitalization. There were no events on the monitor and the CT of the head was negative. The symptoms resolved. She also complained of insomnia back pain for which he received melatonin and Lidoderm patch respectively. She is feeling much better and has been saturating well on room air above 95% for the past 2 days. I will continue with the albuterol inhaler, Decadron and Mucinex as outpatient for few more days. She is asked to follow-up with her PCP for further care as outpatient. ED to Hosp-Admission Discharged 4/13/2021 - 4/16/2021 (3 days) Last attending ? Treatment team Weakness Principal problem Discharge Summary (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Admission Date: 4/13/2021 Length of Stay: 1 Days Discharge Date: 4/16/2021 Admission Diagnosis Hospital Problems POA Type 2 diabetes mellitus (CMS/HCC) Yes Hypothyroidism Yes Hyperlipidemia due to type 2 diabetes mellitus (CMS/HCC) Yes Gastroesophageal reflux disease Yes Problem List Resolved POA Resolved Problems Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) 4/17/2021 Yes * (Principal) Weakness 4/17/2021 Yes Generalized weakness 4/17/2021 Yes Home Under Care Of Organized Home Health Service CODE STATUS: Prior Active Issues Requiring Follow-up Test Results Pending at Discharge Hospital Course HPI: See H&P admit report. Hospital Course: Patient was admitted secondary to weakness and hypoxia she recently did have a bout of COVID-19 and had been discharged home and has been set up for remote outpatient monitoring as per protocol. She returns for ongoing weakness. Patient was continued on Decadron and was seen by physical therapy and Occupational Therapy. The patient slowly continued to improve and was now back to baseline functioning. She may be discharged home and follow-up with PCP as advised as she is no longer on oxygen. She is to complete the dexamethasone dose as she had previously been taking to complete a course. Home health had been previously set up at her previous admission.

"Pfizer-BioNTech COVID-19 Vaccine EUA" - patient admitted with Covid-19 after 2 doses of vaccine (2/18/21 and 3/11/21) 81F history of diabetes mellitus, HTN admitted to hospital 4/6/21 with septic shock, hypothermia, COVID+ pneumonia, pseudomonas bacteremia and AVN blockade. Patient had been having worsening lethargy, dry cough (only associated with eating), and right axilla pain for 1-2 days. Found to be hypoxic with nadir O2 saturation 87% on 4/6/2021 (day of admission). COVID-19 positive test on 4/6/2021. No sick contact reported. Patient problem list included hypoxia, respiratory failure, septic, pseudomonas aeruginosa with bacteremia, COVID-19, right upper lobe consolidation and bilateral effusions, hypernatremia, diabetes. On 4/12/2021, patient also noted to have altered mental status with decreased muscle tone on left side (CVA work up reviewed) and hypernatremia. No nuchal rigidity, No photophobia, and brain MRI findings on 4/13/2021 and on 4/16/2021 were negative. -- > unlikely meningitis/encephalitis. Treatment included Remdesivir, Tocilizumab, Dexamethasone, Antibiotics. 4/6-4/11 in ICU; 4/11-4/17 Med-Surg; 4/17/21 Patient expired.

Office Visit 3/20/2021 Urgent Care PA-C Family Medicine COVID-19 +1 more Dx Fever Reason for Visit Progress Notes PA-C (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 3/20/2021 ? ? Signed Cosigned by: MD at 3/29/2021 9:22 AM Expand AllCollapse All 1. Viral URI 2. Chest congestion MDM Number of Diagnoses or Management Options Viral URI: new, needed workup Diagnosis management comments: The patient's current medications, allergies, problem list, and family history were reviewed. Please see the physical exam. The patient See HPI and physical exam to review pertinent information regarding visit. Images available were reviewed by me and reviewed with pt/family. Prescription medication recommendations were reviewed in light of the patient's age, past medical history and comorbidities.Plan of care reviewed; patient agrees with plan. See patient discharge instructions for more details. Follow up with PCP if symptoms do not improve or go to ER if symptoms worsen. Patient was seen today for fever. Diagnoses and all orders for this visit: Viral URI Chest congestion - POCT COVID-19 Antigen There are no Patient Instructions on file for this visit. History Chief Complaint Patient presents with ? Fever Fever 101 this morning.chest congstion, body aches, chills since Thursday. HPI Patient is a 81 y.o. female presents complaining of chest congestion, cough, body aches and pain in her chest with breathing for the past 2 or 3 days. She denies any loss of taste/smell, sore throat, shortness of breath, vomiting or diarrhea. ED to Hosp-Admission Discharged 3/22/2021 - 4/18/2021 (27 days) Hospital MD Last attending ? Treatment team Acute hypoxemic respiratory failure due to COVID-19 Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Date: 4/18/2021 Admission Date: 3/22/2021 PCP: CRNP Length of Stay: 27 Days Discharging provider: MD Discharge Date: 4/18/2021 Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) Acute hypoxemic respiratory failure due to COVID-19 Yes Myasthenia gravis without exacerbation Yes Toxic diffuse goiter without crisis Yes Long term current use of anticoagulant therapy Not Applicable Hashimoto's thyroiditis Yes Persistent atrial fibrillation Yes Aspiration into airway Yes COVID-19 Yes Anemia, normocytic normochromic Unknown HPI: 81-year-old female with reported myasthenia gravis diagnosed with myasthenia gravis in 2016 noted 5 weeks after finding to have difficulty swallowing and breathing requiring intubation had Plex during admission she was subsequently placed on CellCept and prednisone for long-term but was subsequently weaned off and now follows with neurology Dr., history of thoracic stenosis neck arthritis, Hashimoto's thyroiditis hyperthyroidism on methimazole, heart failure with LVEF of 45%, and atrial fibrillation on Coumadin and rate control agents following with Cardiology who presented to the Hospital on 03/22/2021 with acute hypoxic respiratory failure. The patient reportedly received her Pfizer first vaccine [per patient's son unclear date-but was reported to be due for her second vaccine at the end of this month] and subsequently was found to have fevers and chills on Saturday for which she went to urgent care and was found to be COVID-19 positive for which she was recommended for Tylenol and supportive care. On 03/22/2021 it was reported that she was found by EMS to have acute hypoxic respiratory failure with oxygen saturation in the 50s unclear for how long this had occurred for for which patient was emergently intubated. There was a concern for possible aspiration as as well given unclear how long she was hypoxic for for which she was started on cefepime and vancomycin protocol. Procalcitonin level was ordered. Hospital Course: Please see in details from H&P initially from critical care since patient was being they are almost 22 days. There is multiple consult including cardiologist palliative care note as well as urologist consult note In briefly this is a very pleasant 81-year-old female she had a history of myasthenia gravis currently treated with Dr. not in medication now for myasthenia gravis chronic atrial fibrillation long-term use of anticoagulation Coumadin history of toxic goiter currently on methimazole she was admitted initially on March 22 because she was having chills fever shortness of breath and EMS found that she is having acute hypoxic respiratory failure oxygen saturation is only 50% and emergently intubated admitted in critical care unit. Patient was intubated on March 22 meanwhile patient has a complicated series whilst she was in ICU. She was treated twice for septic shock she was treated first Covid pneumonia respiratory failure with possible aspiration. She was unable to extubate almost 19 days. Eventually she was extubated on 1 April 9. After that patient initially on BiPAP and then she tolerated nasal cannula successfully currently 3 L of oxygen. Meanwhile because of sepsis aspiration pneumonia COVID-19 pneumonia respiratory failure patient was treated with and also urinary tract infection patient was treated with multiple antibiotic vancomycin and Maxipime. For COVID-19 pneumonia she also was treated for tract residual normal. And also Decadron. Patient was not a candidate for remdesivir at that point. After extubation patient, up very slowly patient was transferred to PCU because of tachycardia and hypotension unable to thread beta-blocker digoxin and Cardizem the medication was adjusted pretty slowly patient was started Lovenox injection for bridging Coumadin Coumadin was initially hold been longtime and then after Lovenox injection and Coumadin was started patient currently INR is 1.9 today. She was Coumadin been longtime because her Chad vascular score was high she also had a history of congestive heart failure in addition of chronic atrial fibrillation heart rate is fluctuated in the range of 80-120. She is currently on digoxin we will continue digoxin she is currently on Toprol which started 50 mg and currently 100 mg Toprol she also have a Cardizem with splitting the medication 120 mg p.o. twice daily. Heart rate is better controlled today blood pressure is low borderline this patient need to be watched even in the nursing home for further evaluation of medication adjustment. She also mentioned that she is having chronic hypokalemia potassium was replaced alert here and so then started potassium 20 M EQ p.o. twice daily may need to further adjustment and follow-up potassium in the nursing she she was tachycardic heart rate in module was started recently as 7 days ago now her heart rate is much better now this patient need to see endocrinologist also to follow-up. Patient was complicated with urinary retention and continue straight cath and finally ended up with Foley's catheter this patient must need to evaluate by urology for further evaluation of chronic urinary retention. Meanwhile patient clinically stable vitals are good she does not have any fever shortness of breath tolerable with 3 L of oxygen now she does not have any chest pain she is not in any myasthenia gravis medication this patient will benefit to see follow-up with pulmonary group for post Covid pneumonia require long-term intubation and also neurology for myasthenia gravis Dr. This patient will benefit to a urologist outpatient and also physician to nursing home need to adjust medication in the setting of hypotension tachycardia we will continue Coumadin current dose 7.5 mg and may need to further adjustment slowly. She is currently on 3 L of oxygen we will continue and titrate down slowly. Discharge disposition is nursing home Condition upon discharge patient is awake alert oriented no chest pain still 3 L of oxygen tolerable.

Office Visit 5/4/2021 screening laboratory testing for COVID-19 virus +1 more Dx Cough ? Diarrhea ? Fatigue Reason for Visit ED to Hosp-Admission Discharged 5/5/2021 - 5/17/2021 (12 days) Last attending Treatment team Pneumonia due to COVID-19 virus Principal problem Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Yes Asthma without status asthmaticus Yes Systemic lupus erythematosus (CMS/HCC) Yes Overview Signed 12/1/2020 7:46 AM Note: Document: 08/22/19 - Consults Rheumatology Paroxysmal atrial fibrillation (CMS/HCC) Yes Atrial fibrillation with RVR (CMS/HCC) Yes Esophageal stricture Yes Hospital Course HPI: patient is an 81 y.o. female with pmh of COPD and HTN presented to the ER with complaint of palpitations. She reports since her second covid short on 4/29, she's been feeling "ill." she states she's been having diarrhea, chills, fatigue, and cough. In the ER, she was found to be in afib with RVR. She was given a one time dose of cardizem but then spontaneously converted to NSR. She is not hypoxic but admits to increased cough and occasional dyspnea. CTA was done in the ER due to elevated D dimer. Pulm embolism was ruled out, however, she was found to have bilateral infiltrates concerning for viral pna Hospital Course: Please send details from consultation note from hematology gastroenterology 81-year-old Caucasian female she had a history of COPD hypertension she was admitted through the emergency room on May 6 with a chief complaint of palpitation chest discomfort. She was found to have A. fib with RVR with underlying history of paroxysmal atrial fibrillation. Patient was admitted and atrial fibrillation is rate controlled in maintain with increase his Lopressor. ACS is ruled out by cardiac enzyme patient was found to have a COVID-19 pneumonia fortunately patient oxygen saturation remained good continue having mild cough. And initially she was not started any dexamethasone or any antiviral remdesivir. But over the time patient actually having mild wheezing shortness of breath but oxygen saturation remained stable so then dexamethasone was started. Heart rate was pretty controlled with current medication Lopressor anticoagulation did not start since patient was found to have a severe thrombocytopenia. Patient was seen by hematologist recommend to bone marrow biopsy thought that the sudden drop possible from infectious source. So then that point Heparin Olympic Eliquis was not started. Over the time patient platelet count back to normal platelet count 1 75,000 Eliquis started 2 days ago. Since she looked tolerating Eliquis heart rate is well controlled after adding dexamethasone she is underlying history of COPD her wheezing is much improved and she is currently on DuoNeb. In the history of asthma without status asthmaticus patient will be discharged home with continue current medication Decadron for 5 more days started Eliquis 5 mg 2 times daily since she is tolerating and platelet count is normal I recommend to check CBC for platelet count in 5 days. This patient will benefit to see hematologist outpatient although she refused to do a bone marrow biopsy. She is having chronic low back pain and currently on narcotics recommend to follow-up with PCP to change his narcotic medication.. Initially she had a CTA chest done which was normal although D-dimer was mildly elevated negative for pulmonary embolism and a mild infiltration concerning viral pneumonia so bacterial antibiotic was not started. Stable to be discharged home she was having intermittent low-grade fever for almost like 5 to 10 days. The fever is totally gone now. She is clinically stable new medication is adjusting increase Lopressor 50 mg 2 times daily. Eliquis 5 mg p.o. twice daily and she is going to go home with Decadron only for 5 days.. Patient also have underlying history of chronic dysphagia patient was seen by gastroenterology recommend to follow-up outpatient in 2 to 3 weeks Follow-up PCP in 5 days, follow-up with hematology as scheduled

Presented on 4/27/21 (5 days after 2nd dose of Pfizer COVID vaccine) with acute onset of chest pain around 7am the same morning. Testing ultimately confirmed the diagnosis of acute pericarditis.

Thrombocytopenia; Blood blisters; This is a spontaneous report from a Pfizer-sponsored program COVAX Support. A contactable Other-HCP reported for a 81-year-old female patient that received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Deltoid Left on 19Apr2021 (Lot Number: ER8737; Expiration Date: Jul2021) as 1ST DOSE, SINGLE for covid-19 immunisation . Medical history included deep vein thrombosis. Concomitant medication included apixaban (ELIQUIS) taken for deep vein thrombosis from 29Apr2021 to 30Apr2021. The patient experienced thrombocytopenia and blood blisters on 29Apr2021. The patient was hospitalized for thrombocytopenia from 29Apr2021 to 02May2021. The patient visited emergency room and physician office due to thrombocytopenia. The patient underwent lab tests and procedures which included platelet count: 3,000/dropped on 29Apr2021, platelet count: 348,000 on 04May2021. Therapeutic measures were taken as a result of thrombocytopenia included platelets. The outcome of events was recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the event thrombocytopenia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.

Patient brought to the ED with generalized weakness worsening over prior 2-3 days, states she started experiencing after receiving 2nd dose of Covid vaccine. Found to have a positive troponin, hyponatremia. Stress test revealed reversible myocardial ischemia of the inferior and lateral walls of left ventricle with a large defect size but mild defect severity. Patient underwent PCI with DES placement and was placed on triple therapy with aspirin, clopidogrel and eliquis. Patient presented to ED again on 5/23/21 outcome: patient is brought to ED after a fall and loss of unconsciousness, hit her head with large laceration at back of head, 2 episodes of vomiting, leading to terminal events: brainstem compression and rapid deterioration and CS of 2T preclude meaningful survival

81-year-old female with past medical history of hypertension, chronic respiratory failure on 2 L oxygen at night, asthma, depression, anxiety, atrial fibrillation, coronary artery disease, who presented to the hospital complaining of a shortness of breath. The patient reported that she was vaccinated for a COVID-19 couple months ago 2nd shot, again presented to the hospital for a shortness of breath getting worse for the last 2 days. The patient has been in contact with and exposed to a positive COVID person, her husband, and he is in the ICU. Vitals were T-max 98.6, heart rate tachycardic, tachypneic, and blood pressure 150/100. The patient had a chest x-ray, which showed a congestion as well as right perihilar infiltrate. Patient was in the ER on BiPAP. She denied any headache. No dizziness. No blurry vision. No difficulty swallowing or difficulty hearing. No chest pain. Reported shortness of breath with some chills. No fever. She denied abdominal pain. No nausea or vomiting. No change in bowel habits or urination habits. Diagnosed with COVID on 5/3/2021 prior to admission.

Heavy right foot 4/13 in afternoon. Then Thursday at 2:30am got up to go to the bathroom and had a difficult time walking and returned to bed afterward and had tingling sensation in right arm. Next morning still felt odd and at 8:00am went to primary and he sent her to the ER room. They ran many test and then discovered she had a stroke. There was damage also to the heart. She had lost all mobility in her right side but has since regained it. Transferred to hopital for 3 days. Many test ran. Never previous heart damage or issue with Blood pressure. Supplement list cont. - Immune Defense, B, Apha GPC, Theanine

Two days after patient's first vaccine@ about 4 pm, I could tell that something was wrong with her. Every day she and I play cards, but this day she was really struggling. She couldn't figure out where any of the cards went, and was missing every play. I tool her up to lay down. At about 6pm, her eyes looked really glassy and she was unable to speak clearly. Her words were very slurred, and her sentences did not make any sense. I called 911, and they came and took her to the ER. The doctors said that she had a small stroke. She was put on a low dosage of blood pressure medicine, and was hospitalized for 6 days to monitor her. During that time many tests were run on her. 2nd Vaccine- 2-24-21 Two hours after returning from getting the second vaccine, the patient went upstairs to go to the bathroom and she passed out onto the bathroom floor. Again, when talking to her, her words were slurred. She was very weak. I called 911 again. Initially they were not going to take her, but when she went to get up she fell back down. She was too weak to walk, so they took her to the ER again. She was released to go home that evening. Sher saw her primary doctor and was referred by her oncologist to see a hematologist. She endured a three month waiting period until she could be tested for APLS. She will go this Friday to find out the reslts of that test. Additionally, she saw her vascular neurologist, Dr. He looked at her scans and said it was NOT a stroke. He said that her body basically had a surge as a result of trying to fight off the vaccine. He said that the CAT scan that was done at the time she went to the ER the first time did NOT indicate signs of a new stroke, but that what they were seeing on the scans was from her past stroke. Dr. said that he saw no indication that she had another stroke and that her body was just reacting to the vaccine. He said that all of the symptoms that she had were all things that could happen because of the surge.

she is bleeding into the eye and that to her is just, it keeps getting worse; thrombo; elevated potassium; had bruising in the other leg; doctor did PTT, confirmed as PTT, and it was elevated; This is a spontaneous report from a contactable consumer (patient). An 81-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number, Expiry date UNKNOWN), via an unspecified route of administration at left arm on an unknown date in Feb2021 (at the age of 81 years old) as a single dose for COVID 19 immunisation. Medical history was not reported. The patient received the medications within 2 weeks of vaccination was Asperin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number, Expiry date UNKNOWN), via an unspecified route of administration on an unknown date in Feb2021 experienced adverse events such as large bruising on one leg, after the next dose, bruising on the other leg. She has bruising on both lower limbs, a bleeding disorder. She bled from her eye at the ophthalmologists office. On an unspecified date patient second one, then had bruising in the other leg. She went to the hematologist, and to the doctor. The doctor did PTT, confirmed as PTT, and it was elevated. Reported added that patient also had an elevated potassium. She states this was like what you would get if patient were taking warfarin. it was very concerning now, not only does she have bruising in the leg, but she was bleeding into the eye and that to her was just, it keeps getting worse. She has nothing else to add to that report except that her mom has an elevated PTT, TPTT and states she does not know, it was thrombo. At 81, her mom walks around an hour a day, does aerobics. She was not seeing a hematologist and she was concerned. If she cut herself, she would bleed out. The fact she was bleeding into the eyeball, she has to google the acronym but it was basically clotting issues it was resulting in. No additional details provided; Reporter did not know the name of the elevated test. Information about lot/batch number has been requested.

Acute respiratory failure with hypoxia (HCC) Overview Unclear etiology. I suspect pulmonary edema by CT but cannot rule out CAP or COVID19 contributing.

accompanied with a panic attack; 2nd dose- went into a tachycardia event that was beyond anything she has ever had in the past 40 years; trauma; 2nd dose- extremely exhausted; This is a spontaneous report from a contactable consumer (patient) reported for herself. An 81-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 15Mar2021 (fairly early in the day) (Batch/Lot Number: EN6198) as 2ND DOSE,SINGLE for covid-19 immunization, at the age at vaccination of 81 years old. Anatomical Location of Administration of Pfizer vaccine considered as suspect: She did not really remember but she tends to think it was in her right arm for both. Medical history included tachycardia (This all started when she was 43 years old, and usually gets them periodically; benign with a regular rhythm), ongoing panic attack had for 40 years, ongoing anxiety (reported as she was an anxious person and at first she thought that it was just her anxiety kicking in but the event was beyond anything in 40 years that she has ever experienced). Historical vaccine included first dose of BNT162B2 on 24Feb2021 (Lot Number: EN6200) for covid-19 immunization and experienced tired a little bit. The patient's concomitant medications were not reported. The patient experienced 2nd dose- went into a tachycardia event that was beyond anything she has ever had in the past 40 years (hospitalization) on 17Mar2021 with outcome of recovered on unknown date, accompanied with a panic attack (hospitalization) on an unspecified date with outcome of unknown, 2nd dose- extremely exhausted (non-serious) on 15Mar2021 with outcome of recovered on 15Mar2021, trauma (non-serious) on an unspecified date with outcome of unknown. Reported as she got her second dose on 15Mar2021 and both her husband and her were extremely exhausted, not sleepy, just tired. They were told to expect that though. There was no pain or nothing at the injection site for her. Then 2 days later she went into a tachycardia event that was beyond anything she has ever had in the past 40 years. She knew how to take care of these events and they are usually accompanied with a panic attack and she can usually calm it with breathing. But this was extreme, it was beyond anything in the past 40 years that she has ever experienced. Her husband took her to the hospital and they checked her out and she was okay and her heart did calm down. But what was interesting was that ever since that event on 15Mar2021 she had not had 1 panic attack or one tachycardia episode. She had a slight one not to long ago but it was not like the ones that she used to get. She used to get these events fairly often in a short period of time. She is not sure if the COVID vaccine did anything, but she was grateful if it did but she just wanted to make that comment about the good. 2nd dose- She was extremely exhausted and this began soon after she had the COVID vaccine fairly early in the day. Her and her husband came home soon afterwards and looked at each other and said that they were tired and it was not sleepiness, it was not like they needed a nap. It was profound tiredness and exhaustion. Her husband had it more so but they were both in bed for a couple hours. Neither had pain in the injection site though. This lasted for several hours into the evening. 2nd dose- Her tachycardia event was on 17Mar2021 which was two days after her COVID vaccine. Her husband took her to the emergency room in the early evening that day and when she got there the event was still occurring but it was not as severe. She was in the emergency room for a couple of hours, so late that night she was released and when she went home she was tired. Which she usually is tired after her tachycardia events occur. But while in the emergency room everything checked out. She confirms that she has recovered completely. She was curious if anyone else has reported anything with this same kind of thing she has experienced. She is amazed because she has had lots of trauma in the last week with her grandson and normally an event like that would have her over the top but she has been calm about it. He was 21 years old and he attempted suicide and she cannot believe it. He was out of state and she was so close to him. At the very last moment he told his dad that he is making a mistake and he just can not stand the isolation from college. This normally would send her into the worst but she has been very calm and maybe it just has not all hit her yet and then also the recent events with her husband would normally make her very frightened. She is glad that she has not had any tachycardia events but this all started when she was 43 years old and she usually gets them periodically. She declined a transfer since it is lunch time and she needs to wake her husband for his lunch. She remembered reading articles while she was waiting for her first dose and tachycardia jumped out at her as a side effect and her husband first thought was that seeing that triggered her but she didn't have anything after the first dose so she dismissed it but then it occurred after her second dose. She was more amazed that she has not had an attack since then and she has not had any tachycardia and she has had them for years and she is just so grateful. The events require a visit to Emergency Room. Not to Physician Office: not really because she did it on her own and then she got in contact with her doctors. Information on Lot/Batch number was available. Additional information has been requested

bleeding disorder; severe bruising left leg post shot 1, has large bruising on one leg; This is a spontaneous report from two contactable consumers (one was the patient). An 81-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on Feb2021 at 81 years old as 1st dose, single dose for COVID-19 immunization given in a doctor's office. The patient has no medical history. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. No known allergies. Concomitant medication included acetylsalicylic acid (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Feb2021, the patient had a severe bruising left leg post shot 1, has large bruising on one leg. It was also reported that the patient developed a bleeding disorder after the doses of the Pfizer vaccine. The events required physician's office visit. The events did not result in death or life threatening condition, cause hospitalization, disability or congenital anomaly. No treatment was given. The outcome of the events was reported as not recovered. Information on the lot/batch number has been requested.

Patient presented to the ED on 5/10/2021 for weakness. Patient presented to the ED on 5/17/2021 and was subsequently hospitalized for atrial fibrillation with RVR. These visits are within weeks of receiving COVID vaccination.

blood pressure went up very high, It went up to about 180, 190 even 200 over 80; Anxiety; Headache; slightly nauseous; This is a spontaneous report from a contactable consumer reported for herself. An 81-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot Number: EL9264; expiration date: unknown), via an unspecified route of administration in left arm on 05Feb2021 (at the age of 81-Year-old) as single dose for Covid-19 immunization. The patient medical history included cholesterol and taking medication for cholesterol. The patient stated, she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266; formulation: solution for injection; expiration date: unknown) via unspecified route of administration on 26Feb2021 as single dose for Covid-19 immunization. The patient stated this was the story. She received her two doses of the Pfizer vaccine and the last one received was two and half week ago. Now it's two and half week later and found that number one, after the first dose about 8 days later (unknown date in Feb2021), her blood pressure went up very high. Its normally never get that high. It went up to about 180, 190 even 200 over 80 and then she saw her physician. So, the physician put her on some blood pressure medication, and she got better and then had second vaccine. After that the same thing happen about a week later. Her blood pressure went very high, and she suffered because of it with a lot of anxiety. She wanted to know something about that the blood pressure goes really very high. It was still not regular; it was very irregular. Also, the other thing she wanted to talk about was that when she received the first dose, she had a headache and was slightly nauseous on unknown date in 2021. When she went for the second dose, she did not even look when she was putting a needle in her arm so, felt that the needle went in but shortly after heard her say oh jeez and she know she put it right in her arm, she thought might be she was bleeding, she did not have a look, ended up with a bandage over it and that was it, other day she see it did not have any blood on it. So, one of her friend told her that he had a similar thing happen to him where he felt that some of the vaccine was running down his arm (Further clarification was unknown, hence split was not made) and she was wondering if she got the full dose of the second vaccine, she had absolutely no side effects immediately after over the next day. Also, she took yesterday a test for antibody and that came out negative. The caller wanted to know that if she had antibody now with the two doses. Also asked does the blood pressure go up very high after the two doses. The patient underwent lab tests included antibody test with results shows no antibodies on unknown date, blood pressure (It went up to about 180, 190 even 200 over 80) on unknown date in Feb2021. On an unknown date, the blood pressure was between a 140-150. The patient received treatment included Losartan 75 mg. The adverse events resulted in physician office visit. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289470 same patient/drug, different dose/event

Have a rapid heart beat which she did not have before and a bladder condition also which she did not have prior to getting the vaccine.

2-11-21 Blood pressure was elevated at 150/87. Appointment made at Dr. office. Seen on 2-12-21 Instructed to monitor Blood pressure and call if remains elevated. On 2-13-21 at 7:55am I woke up with a bad headache, dizziness, and slurred speech. EMS called, Blood pressure dangerously high. I was taken to Medical Center with a Thrombolytic Stroke. I had a CT, 2 MRIs, and clot retrieval preformed. Thankfully I can still function pretty normally. The only adverse effects are slight brain damage.

NA from Rehab called RN (on her cell phone) on 7/9/21 to report this patient had an AE 1.5 hours after receiving her Pfizer COVIC vaccine. Patient had SOB and increased anxiety. Her 02 sats dropped in to the 80s. Her MD was alerted and he ordered O2 at 2 liters, benedryl and constant O2 monitoring. Pt was given her usual Lorazapam and Hydroxazine for anxiety and appeared increasingly anxious. Pt. was monitored continuously until symptoms subsided on 7/10/21. She was then back to baseline. RN followed up with facility and reported this AE on the website.

Homebound patient vaccinated with 2nd dose Pfizer at around 10:30 am after the first 15 minutes of observation, around 10:45 patient looked dizzy as she was getting ready to get up from the sitting position to escort us out. At this time, the patient indicated that this happened with the last dose. I noticed her dizziness and pale advised the patient to lie down legs propped up and gave her some water to drink. Attempted to take blood pressure with her own blood pressure cuff but the batteries died out. Continued to monitor for another 15 minutes, while patient continued to lie down and sipping water. After an additional 15 minutes passed I remembered we had a blood pressure cuff in the emergency kit , blood pressure reading was 138/56 and pulse was 76. Pt stated she felt better and wanted to escort us to the door. I advised against getting up and discussed the event with her son in law. Advised to monitor mother in law, call 911 if symptoms worsen. I also asked the son in law to escort us to the door so that the patient did not feel the need to get up out of the bed. Placed a call to person of contact on homebound list, Daughter currently out of town. Advise daughter of the event and to follow-up with her mother to see if she is okay, call 911 if symptoms worsen, and to follow up with PCP regarding event and any other concerns.

My heart rate and blood pressure went up for two days.; My heart rate and blood pressure went up for two days./her blood pressure was 160/82; felt lightheaded; This is a spontaneous report from a contactable consumer or other non-health care professional and other health care professional. A 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 19Mar2021 (at the age of 81-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took olmesartan for blood pressure, indapamide, atorvastatin for blood cholesterol, potassium chloride for blood pressure. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reported that she was trying to decide if she should keep her appointment for the second dose of the Pfizer-BioNTech COVID-19 vaccine. The patient received the first dose on 19Mar2021, was scheduled to receive the second dose on 13Apr2021, and reported to have had some possible side effects. She felt okay within 15 minutes after the first dose. When patient was on her way home (25-28 minutes after) the patient felt lightheaded. Upon checking, her blood pressure was 160/82 and heart rate was 72 bpm (beats per minute) and this continued to go down the rest of the day. The patient asked if this are normal side effects. The patient's husband has allergies and asthma had both Pfizer vaccines no side effects. The patient took the first vaccine and 25 minutes after heart rate and blood pressure went up for almost two days. The adverse events were not resulted in a visit to emergency room and physician office. The patient underwent lab tests and procedures which included blood pressure measurement: 160/82 on 19Mar2021 (Elevated), blood pressure: 121/74 on 19Mar2021 (came back down), blood pressure: 115/69 on 19Mar2021 (back down), heart rate: 72 bpm (beat per minute) on 19Mar2021, heart rate: 75 bpm (beat per minute) on 19Mar2021, heart rate: 96 bpm (beat per minute) on 19Mar2021 (Elevated). The outcome of "felt lightheaded" was reported as resolved on 19Mar2021; blood pressure increased, and heart rate increased was resolved on 20Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Blood clots, strokes, death I believe that there were subtle unrecognized signs starting in March - off balance, slurred speech, confusion- thought to be diabetes related. I would have her check her sugar and it would be fine, but I dismissed it as a good thing that her sugar was ok. It didn?t cross my mind until the major strokes that it could be related to the vaccine. She had major strokes in May as a result of blood clots in heart and head. I strongly believe that her death is related to the vaccine. She was well, and had her diabetes under control, and three months after getting the vaccine, she was dead.

Bowel issues. After vaccination all of her medical conditions became worse. (type 2 diabetes, high blood pressure, and throat cancer was no longer in remission.)

The clicking of the bone is a situation; Left brother's house about 2100, doesn't even remember driving away; The caller states or passed out or what the heck ever is going on with the caller's brain; The second dose Pfizer Covid 19 Vaccine was given in the right arm and had the bad side effect of excruciating pain 3.5 hours later and the pain was for some reason was in left arm.; In the evening, after done driving around doing shopping on that Saturday, 15MAY2021, did not know she fell asleep on the couch with the radio on; Had wobbly ankles, knees and hips; Had blurry eyes; Tiredness; After receiving the second dose Pfizer Covid 19 Vaccine, was what thought was a blood clot coming from the nasal area; It was extreme pain. It has not done anything but stayed in the muscle occasionally; This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported for herself. An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0176, Expiration date: 20Aug2021), via intramuscular, administered in right arm on 15May2021 (at the age of 81-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164, Expiration date: 20Aug2021), via intramuscular, administered in right arm on 24Apr2021 at 12:15 or 12:30 (at the age of 81-year-old) as DOSE 1, SINGLE. The patient medical history includes Pneumonia cryptococcal (Dormant Lung disease cryptococcus), Osteopenia, Pancreatic disorder, Crohn's disease and Colectomy (2002), Cancer, Diabetes mellitus and Polyp, aphasia and seizures (1996). Dormant Lung disease cryptcoccus, this comes from pigeons, bats and birds poo flying in the air. With allergies the caller breathed it in on some far at the time in year 2000. Checked every year since year 2000. Gastroenterologist after many undisclosed solution for drastic weight loss since year 2018, now several tests have determined the caller's pancreas and stomach are not cooperating with each other. The caller has many issues with what the Gastroenterologist are doing with the caller, she feels like a Guinea pig. Concomitant medications include PANCREATIN (CREON) for Pancreatic disorder, AMITRIPTYLINE for Cerebral disorder and CYANOCOBALAMIN (B12-VITAMIIN). The patient was taking concomitant products creon because stomach and pancreas not cooperating with each other. In relation back up to brain thing drug for that is Amitriptyline. Began taking probably 12 years ago, 10 years ago at least. B12 was taking for memory, began taking probably 4 years ago courtesy of all the testing the general physician had done. The caller states she was lacking in so much and will be on this for the rest of life. Amitriptyline was supposed to take 10mg pill twice a day but don't take twice a day. Caller is getting antsy about putting too many chemicals in the body. When the caller is crying again will take more amitriptyline. So far just upset about current Pfizer situation. Only member to have Crohn's disease and intestines removed. Gall bladder, caller has not gotten. Cancer, diabetes and polyps in family history. On 15May2021, after the vaccination, the patient experienced bad side effects of excruciating pain 3.5 hours later and the pain was for some reason was in left arm. This arm pain lasted off and on for two days. It was extreme pain. It has not done anything but stayed in the muscle occasionally, and the shoulder joint was picking occasionally, on the left and the caller still had the clicking. The pain was a normal like grade of 2 to 3 type pain at the time of this report. Whenever the caller twinges the pain happens on its own. Patient also experienced wobbly ankles, knees and hips. The caller's walking was terrible, caller states this is just persisting but at a lower level. The caller is concerned because she is a fracture risk person because of osteopenia. Patient experienced blurry eyes and tiredness. The caller usually gets blurry eyes when the caller is not hydrated enough because of loss of weight and the ileostomy bag itself is free flowing so the caller's retention is not good to begin with. The caller clarifies the infectious disease doctor when the caller was reviewed in April, prior to receiving the Pfizer Covid Vaccines, knew the caller was under weight and severely effected because the caller wears an ileostomy bag due to Chron's disease and intestines being removed twice. The caller's absorption is not normal to begin with. When the doctor's office authorized the caller to get the Pfizer Covid 19 Vaccine in the first place it was within a 20 minute response time and nobody evidently checked the caller's chart prior to approving the caller to get this serious serious of Pfizer Covid Vaccines. Which is why the caller is so annoyed. The patient fell asleep on the couch with the radio on. The caller woke up to her surprise not knowing that she had even gone to sleep for a God knows unknown period. The caller continued to listen to all her favorite shows on the Saturday night radio and it happened again, the caller doesn't know the time it was the caller fell asleep again, patient also states that she passed out or what the heck ever is going on with the caller's brain. Patient also experienced tiredness, she states she delivered the grocers and unloaded the groceries and was really wiped out. She also experienced impaired driving ability that on the way back from her brothers house she doesn't even remember driving away at about 21:00. She states God knows how many minutes later in the caller's driveway sitting at the steering wheel of the caller's car. The caller has no recollection of what transpired in the 12 miles from the brother's house to the caller's house. Patient also experienced blood clot coming from the nasal area on 15May2021. It was a tiny blood clot, not normal, red from end to end. A hair, two or three like hair from the head coming out of the left nostril when the caller blew her nose. Tiny, red tipped white, no pain, no drip, nothing except naturally what came out when the caller blew her nose, hardly. caller states this went away and didn't last at all. on 16May2021, the next day with pain in the arm was off and on. On 17May2021 patient called the doctor's office and listed all of her side effects and passed the message to whatever nurse on duty and the nurse consults the doctor. The caller had been told to do the report to Pfizer for anything wrong. Also, the caller went to the Urgent Care, they told the caller she could not get her B12 shot for memory. The caller states her memory is not too good at the present time. The event blood clot from nose assessed as serious. The patient underwent lab test includes loss of wight 97 lbs at the time of vaccine. The outcome of the event thrombosis was recovered on 15May2021. The outcome of the events loss of consciousness, Somnolence, Joint stiffness, Blurry vision, Fatigue, impaired driving ability and Bone disorder was unknown and The outcome of the event pain in arm and myalgia was recovering.

82 y/o female, PMHx of CA, DM, HTN, hyperlipidemia, IBS, osteoporosis, RLS, seizure disorder, bladder prolapse, and diverticulitis admitted for altered mental status, elevated blood pressure, nausea and shaking, on 6/22/21. Pt tested positive for Covid, but did not exhibit symptoms except may fever. Pt has chronic ulcers on bilateral toe with purulent drainage, undergoing wound care. Toe ulcers found to be source of infection. Was put on clindamycin, Flagyl, and vancomycin (but developed allergic reaction to vancomycin). Pt was discharged to home on 6/23/21.

Rapid heartbeat; Blood pressure dropped; It was even in the 80 over 50; This is a spontaneous report from a contactable Nurse (patient). An 81-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Left upper arm on 23Jun2021 (at the age of 81-years-old) (Batch/Lot Number: EW0180) as single dose for COVID-19 immunisation. The patient had no medical history and concomitant medications. The patient did not receive any prior vaccination (within 4 weeks). The patient reported that she had it on the 23rd and that evening, she started experiencing very rapid heartbeat and then her blood pressure dropped, it took almost two weeks to bring her blood pressure, where it was even in the 80 over 50. When asked about treatment received, patient stated that no, she had to do it herself, her son is quadriplegic (further clarification unknown) and she couldn't leave him by himself. Patient stated causality, "Yes." (not clarified further by appropriately paraphrasing events, hence causality tab left unchecked). Outcome of the event rapid heartbeat was unknown, blood pressure dropped was recovered in Jul2021. Information about Lot/batch number has been requested.

Post Covid-19 vaccine (1st dose) to L Deltoid at 12:15. 12:30 Patient with c/o "dizzy, heart racing" Patient transferred to wheel chair by staff, team lead and BP taken to LUA 191/78 73 and O2 sat 00% ra. Patient given sips of water and BP retaken at 12:33 154/75 62 Patient stated that she normally has high BP however, she has taken her morning metoprolol. 12:38 Patient stated she started to feel better and requested back to be raised, BP 152/85 70. At 12:40 patient informs staff that she is feeling better and wanting to stand and ready to go. Team lead notice patient unstable gait and patient verbalized being dizzy and jittery. Patient return to clinic sitting back down in wheel chair. Patient called to daughter to inform her of her condition and meet at clinic. Team lead attempted without success to encourage patient to be evaluated in ER with transport by EMS. Patient agreed to be evaluated in ED and daughter to transport. BP upon discharge from clinic was 166/89 60 with c/o head ache.

Blood clots; strokes; This is a spontaneous report from a contactable consumer. A 81-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: FT8886), via an unspecified route of administration, administered in left arm on an unknown date in Feb2021 (at the age of 81-year-old) as dose 2, single dose for COVID-19 immunisation. Medical history included type II diabetes, arthritis and fibromyalgia. Prior to the vaccination, the patient was not diagnosed with COVID. The patient taken other medications in two weeks: insulin shots, prescription pain medications, urine medications and anxiety medications. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), administered in left arm on an unknown date in Feb2021 (at the age of 81-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. Post vaccination, the patient had not been tested for COVID. On an unknown date in Apr2021, the patient had blood clots and strokes. The events resulted in emergency room/department or urgent care, hospitalized for 7 days. The patient did not receive any treatment in response to the events. The patient died on 31May2021. An autopsy was not performed. Cause of death was reported as blood clots and strokes. Outcome of the events was fatal. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Blood clots; strokes

Fever, shortness of breath and chest pain that resulted in a heart attack a few hours after vaccination

arrives to the emergency department by POV presenting with a chief complaint of tachycardia onset today. The patient received his COVID vaccine this morning. He states that he does not feel ill, but the only way he can describe how he is feeling is "being lousy". He has had associated palpitations without feeling like his heart is pounding. He denies ever having COVID. He typically takes one baby Asprin per day, and his last dose was this morning.

Stroke-like symptoms approximately 2-3 hours after receiving shot (aphasia), BP bottomed out, was transported by EMS and is currently on a ventilator in hospital. CT scan clear; MRI pending.

vomitting, diarrhea, hypotension, bradycardia 2 hours after the vaccine was given treatment: placing the patient in trendelenburg position until BP improved after 1 hr

Pt brought to ER 1/11/21 & noted to be hypoxic. Patient has been increasingly fatigued for the past several days but with no fever. COVID+ 1/11/21. Treated with remdisivir and discharged home 1/15/21

This is an 82-year-old female with history of cerebellar degeneration, who had her first COVID vaccine today around 11 a.m. she was in her usual state of health prior to that time. About two and half hours afterwards she became nauseated. She had several bouts of emesis and then had a fall. She was found to be hypotensive and bradycardic. The ambulance crew actually gave her atropine at the same because she had a pulse in the 30s, improved her quickly and she presented to the ER. She is to remain very orthostatic, received several liters of IV fluid as now symptomatically better. She remains a little nauseated. She denies any headache, diarrhea, fatigue, or myalgias. She does not feel quite right. She is still dizzy with sitting up.

Resident received the 2nd dose of Covid-19 Vaccine on 01/29/2020, reported feeling Nausea on 01/30/2021 and had 2 falls, second fall resident became lost consciousness while ambulating and abruptly feel to the ground . Paramedics were called and transported her to ER evaluation.

At 0843, RRT was called at the post-vaccination area for an 82 y/o female C/O chest tightness after administration of the Pfizer vaccine at 0836. RRT RNs responded to scene with E-Kit, stethoscope, and pulse ox at hand. Initial vitals ? BP: 190/94, HR: 86, O2: 96% on RA. Client reports that chest tightness does not radiate anywhere else. Client denies N/V, vision changes, or difficulty breathing. Client appears in no acute distress, no sweats seen. Head-to-toe assessment done, all WNL. Client reports she took Metoprolol, Prilosec, a vitamin supplement, and Synthroid this AM. Has a history of macular degermation, thyroid dx, arthritis, and HTN. Throughout RRT, chest tightness improved. At 0855, BP was 182/92. At 0900, client?s head-to-toe assessment remained in WNL. She remained in no acute distress and was not SOB or had difficulty breathing. 911 assistance not needed at this time. Recommendation to client was to be monitored for an additional 15 minutes and that if symptoms worsen, she should contact her PCP and go to the nearest hospital/ER and/or call 911. Client verbalized understanding. At the end of additional 15-minute waiting period, client felt so much better. Symptoms improved. Client left AMA and left premises at 0915 via car.

Daughter contacted the clinical location for vaccination to inquire regarding if her mother was confused when at the location to receive her vaccine as she ended up in the ED 2 hours later with a diagnosis of stroke. completing VAERs due to how closely the vaccine was to the event.

felt dizzy and sick; felt dizzy and sick; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received the first dose of bnt162b2 (Lot Number: EL9261), via an unspecified route of administration in left arm on 21Jan2021 14:30 at single dose for covid-19 immunization. Medical history included Thyroid issues, whole body hurts, car accident in 2006 (lost her arm and husband, she only has part of her right arm), A-Fib, cardioversion (about a little over a month ago), heart disorder. Concomitant medication included apixaban (ELIQUIS) for heart, thyroid medication. The patient previously received the Shingle shots for immunization and experienced tired the next day. The patient experienced increased heart rate, felt dizzy and sick on 21Jan2021. She got the shot on 21Jan2021. She was ok at first but then about 4pm when got home she felt dizzy and sick. She took her heart rate and it was 156. She had A-Fib but just had a cardioversion about a little over a month ago so this really scared her. She felt really sick and didn't want to go into the hospital. She was ok overnight other than her heart was beating too fast. She took her heartrate this morning (22Jan2021) and it was back to 67-70. Today she is just taking it easy. The events did not require a visit to Emergency Room/Physician Office. The second dose is due on 13Feb2021. She is leery of getting it but is going to talk her heart doctor about it and will also see her primary care doctor on Monday. She had a Thyroid issues, things like that. Basically her whole body hurts, this is something that was going on prior to the shot. The only issue with the shot is the increase in her heart rate. There was no treatment, she had nothing to take for this, she doesn't think Tylenol would have helped but she doesn't know. The patient's mom had cancer. The outcome of the events was recovered on 22Jan2021.

Itching, heart racing, high blood pressure (162/86/111) at 11pm. on 1/29/21, day of the event. On 1/31/21 - vertigo during the day, chills. On 2/1/21 at 4:30am heart racing, high blood pressure (168/84/74), vertigo. At 8:52 am blood pressure was 142/70/74. Called Dr. to see if I could be allergic to the shot. She thought my reactions to the shot were probably a normal immune response to the vaccine.

Pt admitted with ICH, likely secondary to increased ICP from nausea and vomiting after receiving her second pfizer covid vaccine.

Mild pressure on her chest and shortness of breath on exertion. She denies shortness of breath at rest any localized or systemic vaccine reactions.

Within 15-minutes of vaccination with second dose, the patient reported SOB/DIB, chest tightness, and sensation of throat closing . EMS administered 1mg Epinephrine and patient developed stridor. Patient became hypertensive (189/85). EMS administered another 1mg Epi and 50mg Benadryl IV. ETCO2 waveform was normal. EMS placed patient 15Lpm oxygen via non-rebreather mask. EKG showed NSR, rate 80 bpm, no ST elevation, and no signs of ectopy. Patient was transported to Emergency Department. In the ED, patient was hypertensive (204/91), but felt improved after EMS administration of epinephrine. Patient refused admission.

Early in the morning on 2/16/21, she has palpitations off and on, but her heart was racing, and she just couldn't figure out what was going on as it was 3 days after the vaccine. It went on all day long, went to bed that night and as she was lying there she questioned whether she was having a reaction to the vaccine or not. She continued to have the racing heart beat since then and still has them, but the periods of having these are getting shorter and shorter.

Long term well controlled Type 1 diabetic, on insulin pump -- on day following vaccination blood sugar spiked to 399, remained elevated for 48 hours, then normal since.

Dyspnea and fatigue with elevated troponin followed by hospital admission and subsequent PEA/Bradycardic arrest. Subdural hematoma found. EF 25%. Likely underlying undiagnosed MM.

Increased blood pressure; Pain breathing; felt some discomfort in her hand; This is a spontaneous report from a contactable Physician. A 82-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 08Feb2021 at 0.3 mL, single for Covid-19 immunisation . Medical history included ongoing cardiac disorder (she has had five bypasses ten years ago) , ongoing lung disorder, ongoing osteoporosis , she has had three operations on her spinal cord. She has a neurologic compression fracture from ages ago , seasonal allergy, nitrate compound therapy, hypertension, anticoagulant therapy, electrolyte imbalance. Concomitant medication included ranolazine (RANEXA), isosorbide (ISOSORBIDE), gliclazide (DIAZIDE [GLICLAZIDE]), apixaban (ELIQUIS), magnesium (MAGNESIUM) , ubidecarenone (Q-10 CO-ENZYME). The patient experienced increased blood pressure on 09Feb2021 with outcome of not recovered , pain breathing on 09Feb2021 with outcome of not recovered , felt some discomfort in her hand on 09Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: increased on 09Feb2021 166/100 and pulse 65. The 100 was alarming to her. The patient would notice the increase in blood pressure and pain breathing when walking longer distances Information on the lot/ batch number has been requested.

Client proceeded to an upstairs restroom post-vaccination, rather than to observation area. Upon exiting rest room, client experienced weakness, mild light-headedness with elevated BP of 203/98. She was evaluated by paramedics on site who recommended further evaluation. Client declined stating she felt better and would take her medication when she arrived home. RN encouraged her to call her physician when she got home. A friend drove her home . A follow-up call was made at 1:46 p.m. by reporting RN. Client stated she took medication, was resting and BP was 168/70, and she was planning to call her doctor. She felt the episode was due to the exertion of going directly upstairs to the rest room, rather than sitting down in observation area.

From admitting hospitalist: received 2nd dose of "COVID vaccine" on 2/16. Felt fine until approx. 2 days later when she experienced increasing fatigue and "feeling poorly" . Stated she spent most of the last week in bed due to severe fatigue. Admitted to the hospital 2/28/2021 with new onset Afib with rapid ventricular rate and new diagnosis of CHF with fluid overload upon arrival.

gets 102 degree fever; Could not speak much next two days; Within one hour or so after: found on floor, fell on right side; unable to speak like a TIA; disoriented; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 at 13:00 at single dose for COVID-19 immunisation at the age of 82-year-old. Medical history included dementia, high blood pressure, allergy to drugs with sulfer. Concomitant medications included 2.5 Amlodipine, 81 mg aspirin, 0.5 clonazepam, 20 mg Escitalopram, 10 mg melatonin, 5 mg memantine, 15 mg mirtazapine. The patient was not pregnant. The patient received first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 at single dose for COVID-19 immunisation at the age of 82-year-old. Within one hour or so after the vaccine administration: the patient was found on floor, fell on right side, disoriented, unable to speak like a transient ischemic attack (TIA), out of it. The patient could not speak much next two days. Don 14Feb21 at 15:00, the patient got 102-degree fever. The patient was treated for the events. The patient was recovering from the events. Information on the lot/ batch number has been requested.

Patient presented to ED with chest pain on her right breast radiating to the back intermittently. No associated N/V, diaphoresis, or SOB. Pt was started on a heparin drip but was later discharged home after being cleared by cardiology. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

10:05 am Pt received vaccine and was seated in observation area. Pt alert, interacting with staff and other pts. 10:15am Pt appears asleep, rouses with touch and when spoken to. Observation area nurse notified, provided pt with bottle of water and helped her take a drink. Nurse then notified pharmacist who came to pt's side. Pt given 25 mg benadryl caplet. Able to swallow it, needed assistance for holding water bottle. Pt breathing regular, pulse regular and easily palpable. 10:25 Pt increasingly lethargic. Nurse and pharmacist with pt. Lips and tongue slowly swelling, responsiveness decreasing. Pharmacist called 911. 10:30am Pt's daughter administered epipen 30mg, L outer thigh. Swelling of lips and tongue quickly resolving. Pt lethargy increasing. Increasingly slow to open eyes and respond to questions. Pulse and breathing continue regular. EMS arrived on scene approx 10:35-10:40. BP 80/60, NSR, pulses palpable, pupils reactive, able to answer questions but slow to respond and weak voice. Pt transferred to Medical Center. In ER pt given IV solumedrol, IV fluids, CXR, EKG. Awake and oriented, arms shaking, weak, requires assistance to stand, intermittently drowsy. Admitted for observation. 3/3/21 pt preparing for discharge, BP extremely high. Pt given metoprolol, BP increased, tachycardia increased, pt very drowsy. Continued to monitor, given Lisinopril, bp decreasing. Pt feeling much stronger, alert, interacting with staff and daughter. Discharged home.