Pfizer

Four hrs. after getting the vaccine. My face started itching, could feel welts under the skin. Swelling of the right side of my face started within a few hours later. Called Drs. , He recommended taking Tylenol. (Second Day) Next day, felt short of breath, weak, applied ice packs to my face. Third day, felt weak. By the fourth day, swelling and itching subsided; but skin on my face felt gritty under the skin. Drove me to the doctor's office the third day. I was short of breath walking from the car to the door to the doctor's office. I was wearing my mask. I saw a PA; but, she didn't tell me much of anything. I don't think she knew what to say.

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

Rash and severe swelling of the face, Hands and throat. Given intravenous benedryl, Pepcid, Ativan, Prednisone

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.

Took shot 1/20 and asked the RN if I should take it because I explained I just got over covid, I told her I wasn?t sure how long it was on Dec 19 I was raking leaves and I thought I should do this because I started having runny nose. I didn?t feel well that afternoon sneezing because I thought it was nothing. As the week went on I started sneezing and coughing and stopped up nose. I always end up with sinus infection when I get a cold Dec 28 I went to the doctor at doctors care and they did a covid test before the doctor would see I tested positive. I went home and rested, no energy, felt like I was hit by a train, couldn?t breathe, sneezed a lot and hardly coughed. January 1, I called ambulance and went to hospital, I was sick the first week of January. I didn?t know that you should wait 90 days to get the vaccine after you?ve had Covid. After I got the vaccination the adverse reaction, I woke up during the night with my arm hurting bad and throbbing and a very large red circle appeared on my arm 2? in diameter. The next 3 days I felt like I had covid all over again, the 4th day I woke up and felt a little better and got out of bed and started making progress each day. Now I?m not good, but I?m ok.

16 hrs after the injection.. i had a shaking chill lasting about 30 min relieved somewhat by tylenol and motrin, followed by feeling hot and sweaty, the next day I was wiped out and rested ... the shortness of breath began somewhat later on weds pm and worsened on Thursday ... I had several breathing treatments thurs and friday which seemed to help somewhat.. On Saturday I am feeling better overall with less dyspnea . still feeling wiped out after several hrs of mild activity.

Patient reported scratchy, irritated throat with some tightness. She was able to swallow and reported that drinking water made her throat feel better. No chest pain or shortness of breath. She reported some anxiety. VS: BP 133/81, HR 83, O2 sat 96-97% on RA Patient felt stable and went home after over 30 minutes of observation.

woke up 15 hours after vaccine with throat swelling, drank warm water and symptoms relieved I 6-7 hour with out any medications He has a history of anaphylactic reactions to peanuts and kiwi so she does have an Epi Pen handy

approx. 2-3 minutes after receiving the vaccine client started c/o feeling lightheadedness and she already had SOB which she normally has. She didn't bring her oxygen with her. She said the dizziness lasted a few minutes and she was monitored and then she said she felt better and was allowed to leave. She denies any other problems at this time.

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).

Patient states she received the COVID-19 vaccine approximately 10:00 A.M. this morning and within minutes after that she noticed a tingling sensation to her tongue and her throat, she then felt her tongue and throat were swelling. She is given intramuscular Benadryl and referred immediately to the emergency room. On arrival to the ER, she states her symptoms are mostly resolving, she denies any swelling in the throat, tongue swelling, shortness of breath, wheezing, abdominal pain, diarrhea, or rash. D/C with cetirizine and recommended follow up with primary care doctor before receiving the second dose of the COVID-19 vaccine.

Client received Pfizer covid vaccine, and during her observed wait time, she became hot and felt a flush through her body. She also reported tingling in her tongue and throat. She reported itching of her chest, cheeks, and ears. Client was brought back to emergency area, and was assess by nurses. Client did have a prior history of allergy to Iodine and shellfish- but never anaphylaxis. 10:20am, pulse 68, bp 142/83, 98% O2. 10:25am, bp 140/85, still complaining of throat swelling and itching, pulse ox stil 98%. Once client was in a private area, she reported that the flushing and feeling of being hot, had gotten much better. Per Client , her tongue and throat, were not getting worse. Our Medical Director was contacted, and the decision was made to give Benadryl IM. 10:39 pulse 70, O2 95%, . 10:41 am 1ml (50 mg) Benadryl given IM in the right deltoid (lot # 080014, exp. 8/2022). Within a few minutes patient reported that signs and symptoms were better but had not completely gone away. 10:44, respirations 14/minute, O2 94%, patient sat up at this time to help clear some phlem. 10:46 client states tongue feels better. 10:53 am 96% O2, pulse 93. Nurses continued to monitor client, and asked if she felt any worsening of her symptoms to warrant more medication. Client stated she felt a little better and would like to go home. 11:15 am, spoke to Docter again, per his instruction, client was allowed to go home with her sister. Instructed to take more Benadryl in 4 hours if symptoms return. Client was told if anything gets worse than her original symptoms, regarding her airway, tongue, lips, swallowing, she should call 911.

Woke from sound sleep at 4 am (approximately 14 hours after having the vaccine shot) -- chilled, and every part of body hurt. Went back to bed. 6 am still hurt everywhere, short of breath (oxygen concentration at 90 and sometimes below--thankfully I had oxygen as I sleep with it). Running a temperature of 100., disoriented, heart rate at 115+ and I hurt everywhere. 8 am called Dr. & left call-back. 1 pm tried Dr. again. Told person on telephone and he told Nurse Practitioner. They ordered nose spray because I mentioned I may have a sinus infection as my head hurt, my ears hurt. I continued Tylenol every 6 hours on Friday and Saturday (all day). I was able to get up and do a few things on Saturday. Felt better on Sunday but still weak feeling. Oxygen saturation back to 95-96 and heart rate under 100.

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.

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

UNKNOWN VACCINE BRAND; Subjective swelling of throat, swollen lips, diffuse eythematous rash on trunk and extremities, anxiety; received famotidine, NS, ativan, diphenhydramine, solumedrol

Dyspnea, wheezing 15 minutes after vaccine dose. Epinephrine administered. Paramedics on scene. Patient refused transportation to ER. Dyspnea resolved 3 minutes post epi.

My reactions started on Feb 10, Wed nite, with pain going from the left shoulder to right shoulder. Next day pain was in the right lung, severe, (could not take a breath). Next day the pain and discomfort traveled dow my right leg, extreme cramps, soreness, etc. The next day it was my left lung in severe pain. By Monday my breathing is very shallow and my cough is much worse, each cough produces its own package of phlem. Breathing is diffiicult I HAVE AN APPOINTMENT TO RECEIVE SECOND SHOT ON FEB. 24. I DO NOT THINK I SHOULD

Dose 1 of Covid19 Pfizer vaccine administered 12/30/20 & dose 2 of Covid19 Pfizer vaccine administered 1/20/21. Patient tested positive for Covid19 on 2/12/21 in the nursing and during hospital admission on 2/18/21. Patient with severe respiratory distress, on Remdesivir since 2/18/21.

Patient reports she got her COVID vaccine around 5:30 P.M. and approximately 20 minutes later developed airway and tongue swelling. EMS arrived and she was given 0.3 mg IM epinephrine, 125 mg solumedrol, 50 mg benadryl, 2.5 mg versed for anxiety. Patient states she is not much better since receiving it, however per EMS she was doing much better.

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

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

Patient was here for her 2nd dose vaccine and during her wait time her tongue started to feel funny and swell slightly. Staff was notified as they were talking with her that her voice sounded a little funny and thick. She also started to cough on a regular interval. As staff continued talking with her she stated her throat started to feel funny and tight. Staff notified other healthcare personal and moved her to the private treatment area. She continued to complain of thick tongue and continued to speak different then her baseline. We elected to give 50 mg Benadryl IM. She was also placed on the ECG showing sinus rhythm with O2 stats of 100 % and her blood pressure was 149/61, After the Benadryl, she stated she started to fell somewhat better. After about 10 minutes her tongue started to swell again and when she turned her head to speak to a staff member her airway shut off due to swelling. Staff quickly turned her head back to forward she was able to breath again. She advised that she needed to be transported and was going to get 0.3 epi IM in her left arm. She did state prior to Epi being given she was now also having trouble focusing visually. Dr arrive to assess her and agreed that she needed transported. EMS arrived and care was turned over to Huntertown EMS to transport the patient to Medical Center.

Within an hour, I felt like I had been hit by a tank; difficulty breathing, dysequilibrium, problems with balance that induced dizziness and vertigo, wobbly gait, extreme weakness, continual tiredness--not refreshed by sleep, difficulty sleeping, insomnia, injection site pain, severe headaches for weeks, eyeball pain, chills, fever, inflammation, joint pain, muscle pain, activity-induced or cognitive exertion muscle fatigue, nausea, swollen lymph nodes, especially in neck, sore throat, difficulty swallowing, cognitive problems -- difficulty with memory, focus, concentration, problems with wordfinding ability, misspeaking; short-term blurry vision; extreme difficulty with body temperature control leading to shaking

10:15- Pt initially c/o left arm numbness sensation, brought back to observation area 10:20- Pt c/o thick throat sensation - Emergency Response Team Called 10:22- Pt c/o increased throat sensation "swelling in back of my tongue and throat" with onset of difficulties breathing- Epinephrine Auto-Injector 0.3mg administered. 10: 26- Emergency Response team arrives 10:28- Pt transported to ER for evaluation

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.

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

Rash in mouth and throat and shortness of breath on Thursday 3/11/21 around 7 p.m.. Called Covid line and spoke to a RN who recommended that I take Ibuprofen and not to take an antihistamine, and to contact my doctor in the morning. Also to go to the ER if symptoms got worse I took Ibuprofen every 4 hours over night and called my primary care physician in the morning. He sent me to the Urgent Care center since the rash had persisted . The Urgent Care physician prescribed Prednisone and Benadryl. I am taking antihistamines and Ibuprofen for relief of rash and itching. I will follow-up doctor on Monday.

half hour after receiving shot tongue and throat swelled up and short of breathe. Throat was sore for few days and short of breathe remained for almost a week It is 12 days and feel better but do not know if I should get second shot

Visited PCP on 3/8/21 with reports of nausea, fatigue, and anorexia following COVID-19 vaccine. Reports body aches, nausea without vomiting, abdominal pain, diarrhea, runny/stuffy nose. Presented to ED on 3/9/21 and reported shortness of breath started 2/28/21. Had COVID positive contact on 2/24. Required supplemental oxygen on presentation. Admitted to ICU on 3/14/21 until present.

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.

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

COVID VACCINE BREAKTHROUGH CASE - COVID SYMPTOMS WITH POSITIVE COVID PCR TEST GREATER THAN 2 WEEKS FOLLOWING 2ND DOSE OF VACCINE; SYPTOMS INCLUDE DIARRHEA, ANOREXIA, WEAKNESS, VOMITING, COUGH, SHORTNESS OF BREATH

Pt is presenting today for Shortness of Breath (pt reprted soa, back pain ( due to rehab 2 weeks ago), nausea, stomach pain, bilateral ankle swelling, drainage in back of throat, right ear is clogged), Pt was admitted to hospital for AMS last month, uncertain underlying cause. Over past few days shes gotten more weak, possibly more confused, more back pain, and lost voice, some congestion and ear congestion. Her son is managing medication. She has SOB and nausea too. No vomiting or diarrhea. Symptoms worsening. No sick exposures, 1st covid shot 2 days ago

Tongue Enlargement, tingles around mouth, itchy ears and axillae, shortness of breath - Benadryl 25mg PO given

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.

Last injection Jan. 28th. On March 15 I started with sore throat and my husband seemed to have head cold. On Tues. his job told him to get a COVID test. He went in Wed. and the rapid test was positive. I went down hill. I had headache, chills, sore all over, sore throat, coughing, shortness of breath, sore tongue, diarrhea, didn't have fever. Was up Thursday night because of shortness of breath. Called Doctors office and was told to go to walk in clinic and someone would come out and get me. Was seen by PA I think. Not a doctor. They only did a rapid test and it was negative. She didn't do the second test and send it off. I have found two people who had the rapid rest and results were negative that the results s Results sent in from second test came back positive. She prescribed Prednisone which helped. I was sick for over two weeks and still struggling with fatigue, aching , sore throat and shortness of breath.

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.

On 2/16, a few hours after the second shot, I started to feel exhausted. For 2 days I slept about 17 hours total. When I got up, I coughed nonstop and wheezed. Codeine cough syrup did nothing. On Mar 5, I was no better, so I went to Urgent Care. They said I had an exacerbation of COPD, but I have never had COPD. They prescribed erythromycin, prednisone, and a Wixela inhaler. On Mar 15, my PCP, Dr. put me back on prednisone for 10 days and added 2 OTC asthma meds. Within 10 days I was much better. On Apr 5, I had some breathing tests that were normal. I saw pulmonologist Dr. on 4/16. He said it might have been a vaccine reaction. I have never experienced anything like this before.

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.

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).

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.

she was gagging and coughing; started to spin; Her throat was so swollen and it felt like she was choking; Her uvula was so swollen that is why she felt like she was choking; choking; severe throwing up; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0158) via an unspecified route of administration in right shoulder (Deltoid Right) on 11Apr2021 in the afternoon around 14:00 or 14:30 (at 76-year-old) at single dose for COVID-19 immunization. The patient's medical history was not reported. None history of all previous immunization with BNT162B2 considered as suspect. Concomitant medication included cetirizine hydrochloride (ZYRTEC) for sinus disorder for years as needed. She took it the day before the COVID19 injection. She hasn't taken it since before getting COVID19 injection. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. She didn't have the ones on the paper. They didn't say she would have severe throwing up she almost had to call. She was choking on 12Apr2021. She was over it currently. She first threw up on Sunday evening and then was ok. On Sunday (11Apr2021 21:00) she only threw up once, but it was four intervals. Caller clarified an interval was where she would throw up then clean up and then throw up again. Then it was fine. On Monday (12Apr2021), in the evening around 9 PM she started to spin. She went to the bathroom and she was heaving and she couldn't say how many times she threw up. Her throat was so swollen and it felt like she was choking. Her throat was very raw. Her uvula was so swollen that is why she felt like she was choking. She was about to go the emergency room, but then looked it up. She did treatment that she saw online for 3 days. When she was gagging and coughing she looked up COVID19 Vaccine and it said that her throat would be swollen from severe throwing up. It made a lot of sense. She had all the symptoms listed online and it said it would get better in five days and if not seek treatment. It has gotten better. No visit for ER and Physician Office. Treatment received for all events. The outcomes of the events were resolving.

Shortness of breath intermittent after first vaccibpne. 2nd vaccine 4/5/21 same facility same vaccine. ER and admission on 4/11/21. Cat scan revealed bilateral blood clots in lungs. Dismissed 4/18/21. I am convinced this was my body?s reaction to the vaccine

4/11/21 Extreme vertigo, nausea, severe vomiting. 4/13/21 Vertigo and nausea persisted, vomiting subsided. 4/15/21 Vertigo, nausea, difficulty swallowing. 4/16/21 Completely unable to swallow. Taken to ER. Upper esophageal sphincter spasm resulting in inability to swallow. 4/27/21 Laryngospasms began intermittently progressing to continuous on 4/28/21 severely compromising ability to breathe. Intubated and placed on ventilator.

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

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.

1/2 hr after receiving dose my throat and tongue swelled up; 1/2 hr after receiving dose my throat and tongue swelled up; My chest started bothering me and I was short of brreathe.; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, in right arm on 08Mar2021 10:30 as first dose single for covid-19 immunisation. Medical history included known allergies to various chemicals, foods, red dyes, high blood pressure and AFIB. Concomitant medications included hydrochlorothiazide, lisinopril, apixaban (ELIQUIS), montelukast, duloxetine and metoprolol tartrate all are taken for an unspecified indication, start and stop date were not reported. 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. Since the vaccination, the patient has not been tested for COVID-19. Patient reports a half hour after she left the facility, she started getting a sore throat, then her throat and tongue swelled up. A little later my chest started bothering me and patient was short of breath on 08Mar2021 11:00 AM. Patient states she is getting better very slowly. This lasted all night and started to ease up the next day. patient took some Benadryl and that helped. As per the reporter seriousness criteria reported as medically significant. Patient received treatment that patient took of Benadryl and she has an inhaler. The outcome of the events was recovering. Follow up needed and additional information has been requested.

Patient had first injection on 3/31/21, and on 4/14/21 patient presented to the ED and was subsequently hospitalized for closed right hip fracture. Patient had second injection on 5/15/21, and on 5/18/21 patient presented to the ED and was subsequently hospitalized for shortness of breath.

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.

Almost immediately after receiving the first Pfizer vaccine my throat began to constrict, my heart started pumping and I was having a hard time breathing. I walked over the the EMT nearby who took my blood pressure which was 188/120. He asked me if I had forgotten to take my BP meds and I responded, I take no meds. He told me to take a seat while he took notes. A few minutes later he took my BP again and it was the same. He gave me a benedryl and a glass of water. The swelling in my throat receded somewhat. He watched me for the next 30 minutes then took my BP again which was 177/120. Feeling somewhat better, I waited another 30 minutes and asked the EMT if I could go home. He took my BP again which was the same and asked me if I wanted to go to the hospital. I said NO. I told him I have a BP cuff at home and would monitor my BP which was normal after 3 days. Needless to say, I have been frightened to get my second shot.

Patient presented to the ED on 4/25/2021 and was subsequently hospitalized for COPD exacerbation. Patient presented to the ED on 5/27/2021 and was subsequently hospitalized for lower extremity edema. These visits are within 6 weeks of receiving COVID-19 vaccination.

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

SOB,Rash,4/14 anaphylactic shock admitted to Er remained overnight for observation, 5/9 rash returned after prednisone ER , 6/10 dermatolgist Dr rash returned. Took scrapping of skin, came back as Grover,s Disease.

After receiving the vaccine I noticed shortness of breath and now it has progressed to the fact I need oxygen 24/7 a day. Before this I was diagnosed with COPD, but I never needed oxygen until now.

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.

Had first vaccine in Jan and second on 2/4. The next week I had trouble breathing. Saw cardiologist and monologist. Diagnosed with interstitial lung disease by inflammation. All tests came back negative including Covid are negative andmy lungs are clear and oxygen in the high 90s. I am wondering if maybe I am having a reaction to something in the vaccine. Are there any tests I can take? Anybody else?

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.

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.

Couldn't raise either of her arms; Chills; Low grade fever of 99.2 degrees Fahrenheit; Sick for 5 days after receiving her first Covid 19 vaccine with flu like symptoms; Throat started tightening; Jaw was sensitive to the touch/tightening of her jaw; Lymph nodes under her jaw were sensitive to the touch; Jaw was sensitive to the touch/Lymph nodes under her jaw were sensitive to the touch; Feeling more and more tired; Entire body was leaden with lethargy; All her joints were aflame; Nauseous; Pain in muscles; Pain in joints; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration in Arm Right on 09Jan2021 12:30(76-years-old at the time of vaccination), (Lot Number: EL3248; Expiration Date: Apr2021) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included cold vaccine and experienced sickness for a week (The COVID 19 vaccine is the first vaccine she's had since 1992. The last vaccine she received was called the cold vaccine. Clarified this vaccine was for the common cold). The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported that She was calling about the COVID 19 vaccine. On 09Jan2021, the patient experienced, throat started tightening, jaw was sensitive to the touch, lymph nodes under her jaw were sensitive to the touch, feeling more and more tired, entire body was leaden with lethargy, all her joints were aflame, nauseous, pain in muscles, pain in joints, chills, low grade fever of 99.2 degrees Fahrenheit, she was sick for 5 days after receiving her first COVID 19 vaccine with flu like symptoms and on 10Jan2021, experienced couldn't raise either of her arms. She wanted to report her side effects because her side effects were dramatic. She wanted to contribute to the research being done on the COVID 19 vaccine. She reported with the first dose of the COVID 19 vaccine she waited the 15 minutes after receiving the dose and got in her car. She lived about 20 minutes from the vaccine facility. Her throat started tightening and her jaw and lymph nodes under her jaw were sensitive to the touch. She had errands to run but she felt herself feeling more and more tired. She needed to eat something, but she hadn't. She couldn't do anything. It was like her entire body was leaden with lethargy. She went home and took a nap for a couple hours. When she woke up from her nap all her joints were aflame. She felt nauseous. She got up to go to the bathroom and went back to bed. The next time she woke up she had pain in her muscles and joints. She has a friend who is a doctor and he told her to take some Acetaminophen. She took the Acetaminophen and went back to sleep and woke up the next day. When she woke the next day on 10Jan2021, she couldn't raise either of her arms. She couldn't raise the arm she got the vaccine in or the other arm. She couldn't reach up to get things out of her cabinets. She also had chills the first night after getting the first dose of the COVID 19 vaccine. She took Acetaminophen again and it eased her muscle and joint pain. She also had a low-grade fever of 99.2 degrees Fahrenheit. Her normal body temperature is low around 97.8 degrees Fahrenheit. She reported she was sick for 5 days after receiving her first COVID 19 vaccine with flu like symptoms. She didn't feel like she could get up and do her normal life for 5 days. On the last day, day 5, most of the other symptoms had gone away. She only had fatigue. The lymph nodes were very slow going getting better as well as the tightening of her jaw, that lasted a long time. She was grateful for protection against the COVID 19 virus and would get the COVID 19 vaccines all over again, but she is not looking forward to getting a COVID 19 vaccine booster. The patient underwent lab tests and procedures which included body temperature: 99.2 degrees Fahrenheit on 09Jan2021 Normal body temperature is low around 97.8 degrees Fahrenheit. Therapeutic measures were taken as a result of, all her joints were aflame, pain in muscles, pain in joints, low grade fever of 99.2 degrees Fahrenheit as Acetaminophen. The clinical outcome of the events Jaw was sensitive to the touch/tightening of her jaw, Lymph nodes under her jaw were sensitive to the touch was recovering, Fatigue not recovered, remaining all other events were recovered on 14Jan2021. No follow up attempts are possible. No further information is expected

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

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.

-March 4, 2020 - Morning after vaccine - Ankles swollen. I never had swollen ankles in the past. Bumps under skin on right forearm - felt like sand pebbles under skin. That has continued and is present now also. - March 6, 2020 - Breathing became tight - remained that way for a good two months. Shortness of breath - Month of March - Rash was breaking out on lower right leg and lower back. itchiness ( But, I was unaware that it was Covid Vaccine related) Gradually became larger rash on right shin area. Right ankle and leg started to swell. - Last week of March, First Week of April - Right leg became more swollen and inflamed. Then became frighteningly swollen. Rash on arms increased. April 15, 2021 - Dermatologist appointment - He told me that the protective barrier on my skin had broken down. Prescribed Steroid cream, and CereVe moisturing cream morning and night. Cetaphil Gentle Skin cleanser used very sparingly on only parts of body absolutely necessary to wash, but not on rash area. No hot showers ever again. He said he would not need an antihistamine. Refused to address swollen leg and ankle. ( Your site tells me it is closing, so I do not have time to continue.)

Pfizer vaccine given at a pharmacy. within 15 minute, pt complained of lightheadedness, face swelling, hand swelling, throat swelling, difficulty breathing. Per patient all symptoms resolved within 15 minute wait period. no medications were given for symptoms.

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.

Resident received Covid Vaccine, noted after 30 mins with labored breathing BP 161/77, HR 116, R 38, T 101.4,

Restriction in normal breezing when sleeping, feels like a lump in my lower throat; Restriction in normal breezing when sleeping, feels like a lump in my lower throat; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 77-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as Covid19 Brand: Pfizer, lot EK4176), intramuscular in left arm on 15Jan2021 15:45 at SINGLE DOSE for Covid-19 vaccination. Medical history included Irritable Bowel Syndrome, Sinal Stenosis, Atrial Fibrillation, Lactose intolerant and Gluten intolerant. She received her first dose of bnt162b2 on 23Dec2020 (lot number: EL128), given via IM in left arm. Concomitant medications included paracetamol (TYLENOL), atropine sulfate, diphenoxylate hydrochloride (DIPHENOXYLATE/ATROPINE) and metoprolol tartrate. The patient experienced restriction in normal breezing when sleeping and felt like a lump in her lower throat on 15Jan2021 22:00. No treatment given. The outcome of events was not recovered.

I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before; I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before; This is a spontaneous report received from a contactable consumer (who is also the patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunization. Medical history included inflammatory bowel disease. Concomitant medication included diphenoxylate from 14Jan2021 for inflammatory bowel disease. The patient stated, "I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before. I never had that before and it feels like I have a hard time when I lay down to breathe and I was wondering if that has anything to do with the side effect of this vaccine." When asked for treatment, patient stated, "No, because it just started yesterday (15Jan2021). That is why I called you. I wanted to know if that dangerous. Do I have to go to an emergency clinic because today is Saturday and everything is closed or should I just do not worry about it." The outcome of the events was unknown.

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.

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.

As per patient daughter - patient had some minor chills on the day of the vaccination - Friday 1/15/21; felt well next day -Saturday, than she was found slumped and lifeless on the couch on Sunday 1/17. Cause of death on death certificate was reportedly put as COPD, Lung Ca and ASHD.

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.

Presented to the ER with complaints of fever, shortness of breath including nausea vomiting and diarrhea. She started getting ill after receiving her second dose of the Pfizer Covid vaccine. Admitted to hospital for 2 day stay.

Difficulty breathing, - Hx of asthma. Evaluated by EMS. O2-99% on room air, HR-68. Client has inhaler in her car and will when discharged.

Patient complained of SOB and dizziness. Patient was assessed by the Medical Assistant and Nurse Practioner. Patient was stable and provider instructed to notify PCP or seek ER help is systems persist or get worse.

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

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.

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.

little tight around my neck and throat, like a tightness; Tightening in my neck and around my mouth area; As soon as I got the shot I felt a little strange; My arms hurting a little; I did not eat anything; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via an unspecified route of administration on 25Jan2021 (at the age of 77-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing low thyroid and mostly it's food allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) 125 ug, daily for low thyroid. The consumer stated, I took the vaccine on Monday (25Jan2021), three days ago and as soon as I got the shot I felt a little strange and I came prepared because I do have some reactions sometimes. Mostly it's food allergies but I guess was being prepared, so I took Benadryl with me and I took it out of the packet. When probed for the treatment, consumer stated, "I just took Benadryl as soon as I got the shot I felt a little strange and I was prepared and I took my Benadryl with me and we stayed there I guess about 45 minutes until I felt better it would have been 12:15 and I was fine." The consumer stated, "I have been trying for two days, that was in my arms hurting a little on an unspecified date in Jan2021 and then today (28Jan2021) around noon I was feeling a reaction again. I had the tightening in my neck and around my mouth area that's where I usually get the reactions from, but for two days I have been fine and I did not eat anything on an unspecified date in Jan2021 out of the way to give me a reaction to it. Now I took 2 Benadryl and it subsided but it's still tight around my neck and a little tight around my neck and throat, like a tightness. What am I supposed to do? After I took this shot on Monday today is Thursday and I am having the same reactions that I had when I took (incomplete sentence) (pending clarification). The outcome of the events as soon as I got the shot I felt a little strange was recovered on 25Jan2021, little tight around my neck and throat, like a tightness and tightening in my neck and around my mouth area was not recovered and other events was unknown.

Exactly 12 hours after second dose : Severe chills ,headache ,fever ,stabbing pains in both legs Shortness of breath Chills lasting 6hours Fever 12 hours Fatigue 2 days Weakness on going.

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.

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.

Rapid onset of fatigue following 15 minutes post observation time, guest sat in chair and notified staff (11:42). Took her own prescribed carbidopa prescription as she stated she was due for a dose and that fatigue is common feature of her Parkinson's and that she usually feels better 20 minutes after medication. She then reported shortness of breath that felt "different" than her usual shortness of breath so internal aid was called for. EMT staff assessed guest to find vital signs stable and able to speak full sentences. Guest reported feeling better at 12:15 and was moved by wheelchair to her ride to go home.

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.

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.

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.

Pt reported facial itching and trace throat tightness post-injection at 11:10 am. Given 25mg Benadryl PO and symptoms resolved with additional monitoring time.

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.

10:25:10 minutes post receiving first dose of Pfizer vaccine pt reported having throat tightness and voice hoarseness "similar to when she has as asthma attack." HR 72, BP 180/60. Pt repeatedly apologizing stating "I'll be ok." 10:27:Ambulance service requested. 1030:Pt medicated w/ Benadryl 25 mg PO per standing order. 10:32 Ambulance arrived, report given to Paramedic. 1040: pt transferred to ambulance. 1045: Ambulance departs site.

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.

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

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.

Decedent received first Covid-19 vaccination on 03/16/2021, has not been feeling well the past week. This past week the decedent stated she had been more tired and was experiencing shortness of breath.

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.

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.

I am 77. I had the Pfizer vaccine, March 9th, with a terrible reaction starting 2 days after. I couldn't use my brain to think, to read with comprehension, to remember things I wanted to remember and had difficulty finding my words. This lasted for 3 days when the fog began to lift. I also had some shortness of breath(SOB) and very low energy. The CDC has said that when giving the injection it is no longer necessary to aspirate (pull back on the syringe) which I was taught to do as a young nurse to ensure that you are not giving the injection into a vein (blood would appear in the syringe.) It is supposed to be given into the muscle which has plenty of veins so if you don't aspirate, how will you know if you are injecting into a vein? A week later, I ended up going to the local hospital ER because of the SOB and had Chest xray, EKG, brain Cat Scan and blood work which were all normal. I debated about getting the second shot but decided to get it as long as the injector gave the injection as I had been taught. Fortunately she was very experienced and agreed to inject me using the pullback method after I explained what I had gone through the 1st time. So for the second shot I had the sore arm but no other reaction. I think Dr is making a mistake about the pullback decision. Do we even know what happens if the vaccine is injected into a vein? I am not certain if my first shot was injected into a vein because the injector never pulled back to check. I have not heard of anyone else with my experience.

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.

Developed massive Pulmonary Blood Clots in both lungs. First symptom was shortness of breath and feeling I would faint. Went to Hospital Emergency room and was admitted immediately spent 2 1/2 days in ICU for treatment to dissolve blood clots (TPA) Was discharged on third day as oxygen level, heart beat, breathing and blood pressure appeared normal. Took second COVID19 (Pfizer-BioNTec) shot on Monday, March 29, 2021 at 1:00 p.m. (Lot ER8732) No adverse reaction to second shot except some muscle paid in left leg (calf).

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.

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

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.

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.

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.

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.

sore throat; swollen glands; she said her throat felt swollen, and like it was closing up; Feeling unwell; Weakness; light headed/weak when standing up; polymyalgia; sick; This is a spontaneous report from a contactable nurse (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9284; Expiration Date: 31May2021), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 14:30 as single dose for covid-19 immunisation. Medical history included polymyalgia rheumatica, Giant Cell Vasculitis from 2020 (Verbatim: Giant Cell Vasculitis, Reported she started taking Prednisone about a year ago for Giant Cell Vasculitis. She said she started at Prednisone 60mg a day, and now is down to Prednisone 10mg a day), Congestive Heart Failure, COPD, Hypertension, Pulmonary Hypertension. There were no concomitant medications.The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1283, Expiry Date: 30Apr2021) on 21Jan2021 via Intramuscular, anatomical location was arm left, prednisone for Giant Cell Vasculitis (she started taking Prednisone (60mg a day)about a year ago for Giant Cell Vasculitis and was down to Prednisone 10mg a day.her side effects are not that bad. She said she just expected to feel better.), flu vaccine (She gets temperature 101 and sick from the flu vaccine, so she doesn't get the flu vaccine anymore and it had been quite a few years since she took the flu vaccine.), pneumonia vaccine (got a pneumonia vaccine about a year or so ago).On 12Feb2021, patient had been on the couch and watching television. She was fine laying down, but when she got up, she was lightheaded and didn't feel well and had weakness when she got up. Patient had a sore throat with swollen glands in her neck, her throat felt swollen and like it was closing up and glands started hurting on 15feb2021. She was sick when got up, but when lay down she was fine. she had polymyalgia was doing better before the vaccination. She was wondering if it was normal for the COVID-19 Vaccine side effects to last that long or were the COVID-19 Vaccine side effects expected to last that long. Wanted to know if because she was taking Prednisone, her COVID-19 Vaccine side effects were lasting longer. Patient stated she always thought she was 5'5", but the last time she was measured at the doctor she was told she was 5'. No further details provided. her shortness of breath is worse since she got the COVID-19 Vaccine. She said she was doing better before she received the COVID-19 Vaccine. She took 1 Tylenol on 11Feb2021 and again on 15Feb2021 (Lot Number: 06V1489, Expiration Date: May2022). She said she took 2 Equate Brand Tylenol 500mg tablets because her throat felt swollen, and the throat swelling went away on 16Feb2021. Patient had severe pulmonary hypertension until she had a cardiac catheterization. She said she was told from the cardiac catheterization that she had the potential for pulmonary hypertension but did not have severe pulmonary hypertension. She said prior to the cardiac catheterization she had years of cardia echos performed, and the cardiac echos were not correct. The outcome of the event throat felt swollen was recovered on 16Feb2021, for feeling unwell, lightheadedness, weakness it was not recovered and sore throat, swollen glands it was recovering.

After receiving COVID dose 2, patient was found sitting on the floor in the pharmacy waiting area. She seemed to be mildly short of breath and patient seemed to be slightly dizzy. Patient was assisted to a nearby chair and seemed to be recovering. She and her caregiver remained there as I returned to the pharmacy and they were within my line of sight. A few minutes later they were gone and it was assumed they left the building. They were in a different part of the store and the patient sat on the floor again. Her caregiver called 911 and she was transported to a local medical facility.

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

ear feel like they were popping/ears pop when she swallows; Sore throat; Throat was swollen; fever; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL9261, Expiration Date was not reported), via an unspecified route of administration on 25Jan2021 (at the age of 77-year-old) as 1st dose, single for covid-19 immunisation. Medical history included covid-19 from Sep2020 to an unknown date, breast cancer female (Breast cancer with lymph node removal) from 2012 to an unknown date, lymphadenectomy (Breast cancer with lymph node removal), type 2 diabetes mellitus, blood pressure abnormal. Concomitant medications included metformin hcl (METFORMIN HCL, 500mg) taken for type 2 diabetes mellitus from 2006 and ongoing; simvastatin (SIMVASTATIN, 20mg) taken for blood pressure abnormal from an unspecified start date and ongoing. It was reported that, patient got the Pfizer COVID-19 vaccine on 25Jan2021 and on the next day (26Jan2021), she had a fever (101.1F), diarrhea, and chills. It reminded her of her having COIVD-19 back in Sep2021. She said she took some Tylenol and She put compresses on her forehead and neck, then her temperature went down to 99F. She didn't have chills. She did have diarrhea on Tuesday as well, her temperature remained on 99F and caller had no fever since then but on Wednesday (27Jan2021), She was fine on Wednesday. Then on Thursday, her throat was sore. Her throat was still sore when she swallows. She has not had trouble breathing, her throat was swollen and her ear feel like they were popping. Her ears will pop when she swallows. She said it was uncomfortable. It was just annoying. She checks her temp, pulse, and o2 intake every day. They are good. She heard them say something about 3 when they were talking about the dose. She had COVID back in Sep2020. It was a mild case. She had diarrhea and a temp. That was it. She wasn't sure if she could get it again, or if she could carry it and give it to someone. That was why she decided to get it. She also had breast cancer, and her lymph nodes removed in 2012. She was due for her second shot 16Feb2021. She taught school for 32 years. She has a doctor's appointment tomorrow (04Feb2021) and will have some bloodwork done. She said she monitored her pulse (heart rate was on 70s) and oxygen level (94 or 97) and said they were good. She wanted to know recommendations for the second dose considering this AE. The patient underwent lab tests and procedures which included body temperature was 99 on an unspecified date, body temperature was 101.1 on 26Jan2021 , body temperature was 99 on 27Jan2021, heart rate: 70s/good on an unspecified date (She said she monitored her pulse (heart rate was on 70s/She checks her temp, pulse, and o2 intake every day. They are good) , oxygen saturation: 94or 97/good on an unspecified date (oxygen level (94 or 97) and said they were good/She checks her temp, pulse, and o2 intake every day. They are good), sars-cov-2 test: positive on Sep2020. Therapeutic measures were taken as a result of fever (pyrexia). The case was non serious. The outcome for the event fever was recovered on 27Jan2021, for events chills and diarrhoea was recovered on 26Jan2021, not recovered for events ear feel like they were popping/ears pop when she swallows, Sore throat and unknown for other events. Follow-up attempts are completed. No further information is expected

weakness; muscle pain; tiredness; has not been feeling well; headache; nausea; vomiting; some difficulty with breathing; This is a spontaneous report from Medical information team. A contactable consumer (patients daughter) reported that a 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on 01Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 Immunization. It was reported patient experienced side effects include, weakness, muscle pain, tiredness. Her mother has not been feeling well. She does not feel 100% today. She was calling to see if these symptoms are related to the shot. Her mother has experienced tiredness, headache, muscle pain, nausea, feeling unwell, vomiting, some difficulty with breathing. She was sitting up currently and was fine but was not 100%. She also has weakness. Outcome of the events was unknown. Information about batch/lot number has been requested.

Itchiness on chest; rash on chest; Shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, in Arm Right on 24Feb2021 13:30 (at the age of 77 years old) (Batch/Lot Number: ERV6200) as single dose for COVID-19 immunization. Previously the patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration, in Arm Right on 04Feb2021 14:00 (at the age of 77 years old) (Batch/Lot Number: EL9264) as single dose for COVID-19 immunization. Medical history included trigeminal neuralgia. Concomitant medications included gabapentin; oxcarbazepine taken for an unspecified indication. The patient has no known allergies. On 24Feb2021 at 09:00 the patient experienced itchiness and rash on chest, Shortness of breath and self-administered Cortisone cream only on chest. No other vaccines were received in four weeks. The patient had no covid prior vaccination and was has not been tested for Covid-19 post vaccination. Therapeutic measures were taken as a result of itchiness and rash on chest, shortness of breath. The clinical outcome of the events was recovering. Follow-up attempts completed. No further information expected.

Difficulty breathing/she could barely breathe; felt like her "left lung is made of stone"/felt like her left lung felt like it was going to her back; had pain in shoulder blade; felt like she is not getting enough oxygen/she was not getting enough oxygens to her brain; slept for 12 hours; she was angry and upset; she was angry and upset; her voice has changed; she has some wheezing but it is coming from in between her soft and hard palate; States after the vaccine was tired and lethargic; States after the vaccine was tired and lethargic; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot number: EL9264, Expiration Date: 31May2021), via intramuscular, administered in Arm Left on 09Feb2021 (Age at vaccination 77 Years) as 1st dose, 0.3 ml single for covid-19 immunisation. The patient had past drug event to a reaction to the inhaler that was prescribed to her, had excruciating pain in feet, hands and knees never happened in her life. Inhaler was Albuterol sulfate, HFA, inhalation areol, 90mg per actuation, 18gm, inhale 2 puffs into lungs every 4 hours as needed for SOB, she did have Covid in Nov2020 prior to the vaccine, concomitant medications were not reported. The patient experienced she had been calling since the 16-17Feb2021, a week after she had the first vaccine shot on 09Feb2021 states about 2 hours after the first Pfizer Covid vaccine, she had difficulty breathing thought maybe it was a side effect from she had Physical Therapy earlier that day, but stated as the week went on the difficulty breathing, even walking down stairs, become more difficult, states the following Tuesday, she went to Physical therapy and everything went okay and when she came home and walked two houses down the road to her neighbours house to drop something off. she could barely breathe on 09Feb2021, felt like her "left lung is made of stone"/felt like her left lung felt like it was going to her back, had pain in shoulder blade, felt like she was not getting enough oxygen/she was not getting enough oxygens to her brain, slept for 12 hours and went to urgent care, (unspecified date in 2021) she was angry and upset she has some wheezing but it was coming from in between her soft and hard palate, her voice has changed sounds gravel-y, stated after the vaccine was tired and lethargic. She laid her head down on the table and went to sleep for 2 hours at the kitchen table, does not believe she had brain damage. She wanted to know she did not have good experience with first dose. Her second dose was due today and stated she will be late for her second dose, also wanted to know "YES or NO" about taking the second dose. States the urgent care doctor told her they have a theory that she already had antibodies in her body and then the influx of antibodies from the vaccine caused the reaction. The patient underwent lab tests and procedures which included sars-cov-2 test and she did have covid-19 on Nov2020 states she did have Covid in Nov2020. Patient received treatment of Stated she went to urgent care and they gave her a breathing treatment. The outcome of events was difficulty breathing/she could barely breathe was recovering, rest of the all events outcome was unknown. No follow up attempts are possible. No further information is expected.

shortness of breath; This is a spontaneous report from a contactable other health care professional (Nurse reported about herself). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EL1283; Expiration Date: 30Apr2021) via intramuscular, administered in Left Arm on 21Jan2021 (at the age of 77-year-old) as dose 1, single for covid-19 immunization. Medical history included polymyalgia rheumatica, Giant Cell Vasculitis from 2020 to an unknown date, congestive heart failure, chronic obstructive pulmonary disease, hypertension, pulmonary hypertension. Concomitant medication included prednisone 60mg once daily. Historical Vaccine included flu vaccine and experienced sick. She said each time she got the flu vaccine, she would get sicker, so she doesn't take the flu vaccine anymore. She said it has been quite a few years since she took the flu vaccine. Reported she got a pneumonia vaccine about a year or so ago and she is due next month for her blood work. No further details provided. On an unspecified date in Jan2021, the patient stated that her shortness of breath is worse since she got the COVID-19 Vaccine. She said she was doing better before she received the COVID-19 Vaccine and she is unsure if her side effects are because of the COVID-19 Vaccine, or if it is because she has been on Prednisone. Event assessed as non-serious by reporter. Therapeutic measures were taken as a result of shortness of breath. Outcome of event was not resolved. Follow-up (14May2021): Follow-up attempts completed. No further information expected.

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.

very very itchy.; inflamed; these isolated spots on your right and your left elbow and one side of my face and my neck, so it was isolated, it was not a rash but so itchy and red and inflamed; big red blotch that was very itchy; I was going crazy; didn't sleep; My asthma has been worse; hive like hard bumps around elbow of same arm, as well as near ear of right side.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM6198) via an unspecified route of administration on 02Mar2021 (at the age of 77-year-old) as dose 2, single for COVID-19 immunization. Medical history included years ago penicillin allergy but have had since, bug bites allergy, allergic to mosquito bites and to insect bites, asthma, minor arthritis/spine, acid Reflux, high cholesterol. Concomitant medication(s) included atorvastatin calcium (STATIN), folic acid and multi-vitamin, vi taken for an unspecified indication in two weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) administration on right arm on 09Feb2021 (at the age of 77-year-old) as dose 1 single for Covid-19 immunization and experienced similar event with 2nd dose along with large blister. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On an unspecified date in Mar2021, the patient experienced similar events happened again after 2nd vaccine 02Mar2021 in same spots, no big blister just both elbows and neck, very very itchy as well as hive like hard bumps around elbow of same arm, as well as hive like bump near ear of right side. Followed by very itchy bumps on left arm at elbow site. Patient informed that after the 2nd shot it affected 2 elbows and the neck but no blister (same as the first but the first had the giant blister) and had gone to 2 physicians who didn't know what it was or if it may be an allergic reaction no one had identified it. Patient thought it was bug bites (allergic to mosquito bites and allergic to insect bites). It was so inflamed for a month patient was going crazy and doctor gave prednisone and Zyrtec. The 3rd person, patient spoke with thinks it's covid arm. No one can tell her what it was. Patient been to a dermatologist and internal doctor. Thinks it's the reaction to the covid vaccine. The problem with the reaction was when it's so inflamed. It feels like she got mosquito bite (like when she get a reaction) and didn't sleep the whole night. The doctor said, "I can't tell if it's a bug bite because it's so inflamed." Patient's asthma has been worse. It's horrible to have this. Thinking patient had bed bugs, it's been driving her crazy for a month. Patient informed that it's not just some itchiness, at first sight she thought she had insect bites. It happened in two locations under the right side of my neck which is like a big red blotch that was very itchy at the same time on my right arm and so the second time it happen it was not that bad, just in these isolated spots on right and left elbow and one side of face and neck, so it was isolated, it was not a rash, it was like an allergic reaction to mosquito bite but so itchy and red and inflamed. The doctor gave the patient antihistamine and now taking prednisone. Patient also asked about tests available to see if she had an allergic reaction to the pfizer vaccine. If the vaccine had histamine or would people who had allergies to bug bites have allergies to the Pfizer vaccine. The outcome of events hive like hard bumps around elbow of same arm, as well as hive like bump near ear of right side and very very itchy was recovering and rest all events was unknown. No follow-up attempts are possible. No further information is expected.

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.

Apr 28th began noticing right upper abdominal pain, from the sternum area, down and around base of right lower rib cage and toward my back. A tightness feeling going also toward my back. Interfering with breathing because pain increase with deeper breath but did not feel short of breath. Area became tender to touch. Felt like muscle spasms in "bread basket" area. These cont'd off and on - affecting size of meals I would eat - too much increase the discomfort. Self exploring lead me too exercising and deep breathing to advice via website. Provided some relief and improved breathing ability. By May 2th things became more severe- 3 morning episodes of severe gripping pain, sweats, chills ,nausea, vomiting, weakness - Husband took me to Emerg May 4th. Bld in urine. Kidney scan - no stones; Bld work - normal. Agan in Emerg June 29th. No medical reason given for the severe pain. Sent home.

It felt like it was kind of closing; reflux; swelling under her upper lip; swelling of her throat; This is a spontaneous report from a contactable consumer or other non health care professional from a Pfizer-sponsored program . A 78 year old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EL0140 ), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jan2021 13:00 (Age at vaccination: 77 years) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included she has a lot of food a lot of food allergies including nuts, and seeds. She was very allergic to poppy seeds and would like to know if any ingredients have been derived from poppy seeds. Patient did not received prior vaccination in 4 weeks. There were no concomitant medications. The patient experienced swelling of her throat and swelling under her upper lip in Jan2021. Patient reported, it felt like it was kind of closing, reflux, on an unspecified date. within 24-48 hours felt a little feeling of swelling of her throat. It felt like it was kind of closing. She got an EMT Scope and they saw that her throat was swollen. They thought that it was because of reflux and gave her reflux medications which did not help. ENT said her throat was swollen and she has some swelling under her upper lip. She thinks it was something to do with the vaccination. Then she received the second 28Jan2021 13:00PM in the right arm. After the second dose she continued to feel like her throat was swollen and her upper lip underneath feels swollen. Adds you can't see it but if you lift up her lip you can see it was swollen. She saw an ENT and an allergist who confirmed everything. It was further reported that after 1 month she finished the 2 doses of Pfizer covid-19 vaccine, she stated that she received the 1st dose last 07Jan2021 and started feeling like there's a pressure on the back of her throat, since she was feeling that she visited a physician and telling her that it's just a reflux. but since she was feeling that her throat was closing she started taking medication for reflux. (3 weeks) and she noticed that she's swelling/tingling in her upper interior lips. but she was advised that there's no medical intervention but until now she had all the reactions after 1 month. The outcome of throat is swollen and swelling under her upper lip was not recovered. The outcome of the rest of the events was unknown. No follow up attempts are possible. No further information is expected

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.

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

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

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.

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.

7/20/21 1st Covid vaccination (pfizer) appt was at 10:30 actually received injection approx 11:15 am. around 6 hrs later, left arm/injection site began to ache. THEN, approx 8:00 pm, (approx 9 hrs after injection) I experienced slight shortness of breath (sob) plus some fatigue, headache, dizziness. Was able to go to sleep--after a while. Next morning, 7/21/21 sob more noticeable. Didn't do my regular 3-4 mile walk. By afternoon (7/21/21) great fatigue, greater headache, dizziness and shortness of breath stronger. In middle of day I went to bed and slept 4 hrs. --to nap like this...very rare except when I had Covid, late 2019/early 2020. Following evening, 7/22/21, approx. 8:00 PM, because that day had been free of sob, I took dog for walk...only reached l/8 mile, or less, because sob returned, in a stronger manner. I had to rest before able to walk back home. By 9:15 pm, same evening (7/22/21), sob worsened--although only sitting at computer. Husband found my 2019 rx of "albuterol sulfate" inhaler...( 90 mcg per puff, take 2 puffs back to back) something I've NEVER used before. This was prescribed because in 2019 because of extreme sob, now considered to be symptom of Covid. The inhalant helped. July 27, 2021, I had to use inhalent again--sob.

"Pfizer-BioNTech COVID-19 Vaccine" 12/29 patient developed SOB, fever tmax 103 degrees F, diaphoretic, dry heaves all started approximately 16 hours after vaccination given. patient then transferred to Hospital for further treatment and observation. 12/30 seen at injection site- erythema, swelling, warmth and tenderness Discharged back to home on 1/1 with RX for cephalexin to treat cellulitis of injection site

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.

CDizzy. Weak after an hour, increasing so could barely stand by 8 pm. severe abdoominal pain, chills, throat swelling during night, feeling as id needles pricking entire body for an hour or so around 2 or 3 am. Better next day exvept tired and weak. Ok since then.

She has shrunk; weighs less. Maybe 154 pounds. She was 170; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; had congestion; Coughing; choking; body was more than hot it was burning/body turned very hot; could not sleep/two sleepless nights; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization, ciprofloxacin (CIPRO), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication and pirfenidone (ESBRIET), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. Medical history included pulmonary fibrosis (diagnosed between 2007-2010), Lymphoma type B, blood pressure (abnormal), cholesterol (abnormal), vertigo, biopsy, tightening of legs and feet, drip (nasal) and pain. Concomitant medication included gabapentin for tightening of her legs and feet, diphenhydramine hydrochloride (BENADRYL) for drip (nasal) and meloxicam for pain. It was reported that the patient took the vaccine and had two sleepless nights on 05Jan2021, her body turned very hot but she have some conditions. Sleepless nights: they have been really rough nights. Scary. Coughing and choking. She thinks the vaccine kicked in and started beating the hell out of it. The patient clarified that she is having sleepless nights because of the coughing, choking, and burning and she feels that it is related to the vaccine kicking in. She slept last night, 14Jan2021. The cough is starting again today (as reported). She hopes it calms down. When she said her body was hot, like burning she was describing her sleepless nights. She is afraid. She is keeping in contact with her doctor. She figured she better call because more people are on this medication. The patient also experienced congestion on 06Jan2021. It was reported that the patient has shrunk and weighed less. Maybe 154 pounds. She was 170. The action taken for ciprofloxacin and pirfenidone was unknown. The outcome of the event congestion was not recovered, while unknown for the rest of the events.

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.

In one minute dizziness and couldn't clear throat little swollen. They checked heart beat and blood pressure and injection site and kept me extra waiting time

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.

Patient in clinic for 2nd dose of covid vaccine. Within 8 minutes of receiving her injection, pt developed a rash on both arms; pt states both arms are itch and her throat felt as if it were closing. Rapid response called and patient was given Epinephrine per anaphylaxis protocol by LPN at 4:26pm. BP-146/98 p88 R17 Rapid response team arrived at 427pm. 429pm: Assessment: patient stable but felt no improvement in her throat. Pt was transported to ED for assessment.

ASTHMA WAS UNDER CONTROL PRIOR TO THE VACCINE. AFTERWARDS, MORE DIFFICULT BREATHING WHEN EXERCISE OR BUSY. INCREASED MUCUS. ADDED MUCINEX TO MEDICATIONS. AS OF 2/1, MY ASTHMA IS STILL WORSE THAN IT WAS BEFORE. hOWEVER THE FIRST 2 DAYS OF THE REACTION WERE MORE SIGNIFICANT THAN NOW.

1/27/2021- Fatigue 1/28/2021 around 2 AM- Coughing, Difficulty breathing had to use breathing machine and inhaler, hoarse voice, fatigue. Ended up sleeping over 12 hours Went to lung doctor 1/29/2021- Still feeling same symptoms as 1/28/2021. Said had an adverse reaction to vaccine, prescribed to keep using inhaler and breathing treatments as needed, also prescribed AZITHROMYCIN 1/30/2021- Started to feel a little better, not as hoarse. 1/31/2021- Significantly Better than before. Still coughing 2/1/2021- About 70% better still coughing a little but improved

On 1/9/21-Diaphoresis, O2 90%, respirations 22, increased weakness, wheezing bilaterally. Send to ER for evaluation and treatment. She was sent to ER, where she was admitted for 2 days, then expired there on 1/11/21

[Pfizer covid -19 vaccine] treatment under Emergency Use Authorization(EUA): Patient in clinic for 2nd dose of covid vaccine. Within 8 minutes of receiving her injection, pt developed a rash on both arms; pt states both arms are itch and her throat felt as if it were closing. Rapid response called and patient was given Epinephrine per anaphylaxis protocol by LPN at 4:26pm. BP-146/98 p88 R17 Rapid response team arrived at 427pm. 429pm: Assessment: patient stable but felt no improvement in her throat. Pt was transported to ED for assessment.

Pt alerted circulating RN that she was feeling tightening in her throat. Pt mentioned that she wanted to walk to the room because she was not feeling dizzy. Pt was asked about any heart problems and she responded that she has a pacemaker. Pt was taken to a private room for further monitoring and observation. Patient asked about history of this problem, to which she replied that this has never happened before. Patient mentioned that her allergic reactions typically consist of a rash or hives. Vitals were taken and recorded. BP was initially high at 180/80. Pt declined admission to the emergency department. Pt awake and alert, good historian. No difficulty speaking or breathing. No shortness of breath, denied chest pain, reported "tightness" and pointing to neck area. Pt described, "feels like I have phlegm there." Denied water. No drooling & speech clear. No numbness to extremities or aching to shoulders, no nausea, no dizziness. Pt ok to sit up and accepts water at 11:38AM (20 minutes following initial incident), denies food and juice. Swallows multiple sips without difficulty. Pt denied throat tightness or pain. EMTALA Form completed. Pt education performed regarding potential side effects of COVID-19 vaccine and sources of information going forward. 11:43AM pt feels comfortable to walk and wants to go home. Pt discharged to home ambulatory, stable VS and states understanding of plan of care after COVID 19 vaccine today.

view 2/5/2021 09:23 e Progress Note Note Text: Patient passed away in the facility this morning. view 2/5/2021 08:39 Orders - Administration Note Note Text: Resident passed. view 2/5/2021 08:33 Nurses Note Note Text: Body released to funeral home at this time. Personal effects sent with resident include: 1 pair of glasses, 1 yellow wedding band, 1silver spoon ring, 1 ring with black and clear stones. Resident has own teeth view 2/5/2021 08:32 Nurses Note Note Text: cause of death per CRNP failure to thrive. view 2/5/2021 07:44 Orders - Administration Note Note Text: Take and document temp & PO2 every 4 hours for MONITORING Resident passed. view 2/5/2021 06:49 Nurses Note Note Text: Son returned call and was updated of resident's passing this am view 2/5/2021 06:33 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Unknown Resident expired @ 0604 [linked] view 2/5/2021 06:06 Nurses Note Note Text: Res found without pulse or respirations. Pronounced at 0604. Updated. N/o's for RN to pronounce, release body to funeral home, dispose of medications per facility policy. Daughter updated. Funeral Home called to release body. view 2/5/2021 05:26 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger Pulse ox 60% on O2 @ 5L/min via mask. Resps 44 per minute. view 2/5/2021 01:57 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Effective Follow-up Pain Scale was: 2 [linked] view 2/5/2021 00:52 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger Residents resps are 40 per minute, pulse ox 76% on O2 @ 5L/min via mask. Resps are labored, shallow and rapid. view 2/5/2021 00:48 Nurses Note Note Text: Nonresponsive to verbal and tactile stimulation. Appears comfortable. view 2/4/2021 22:01 Nurses Note Note Text: Resident resting comfortably, breathing becoming increasingly shallow, wearing O2 via mask at 5L via mask, no dyspnea noted, feet are mottled, oral and peri care provided Q2H. No s/s of pain or discomfort. view 2/4/2021 21:40 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Effective [linked] view 2/4/2021 19:32 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger medicated for air hunger, RR 28 to 32/ min view 2/4/2021 19:22 Nurses Note Note Text: Daughter updated on N/O to increase Morphine Sulfate 20mg/mL 0.25mL to Q2H prn from Q6H prn. view 2/4/2021 18:06 Nurses Note Note Text: POA Daughter and daughter aware of residents current condition. view 2/4/2021 11:58 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN Administration was: Effective Follow-up Pain Scale was: 2 [linked] view 2/4/2021 11:13 Nurses Note Note Text: Pt. noted to be lethargic at this time. Does respond to verbal and tactile stimuli by opening her eyes but non verbal currently. Skin warm and dry. No mottling or apnea observed at this time. O2 sat 88% with O2 at 2 LPM via n/c. On increased to 3 LPM via mask as pt. noted to be mouth breathing. Respirations 28. F/U O2 sat 93%. HOB elevated. Pt. medicated with morphine by LPN. Daughter updated on pt.'s condition. Does not want pt. sent out to hospital and would like comfort measures to continue. Daughter also in agreement with delay in d/c d/t pt.'s condition.CRNP updated on pt.'s condition, delay in d/c and daughter's wishes. No n/o's at this time. view 2/4/2021 10:56 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB Resident showing s/s of discomfort. SOB at this time and high respirations. Repositioned, changed for incontinence care and mouth care provided. view 2/4/2021 10:34 Progress Note Note Text: Spoke with RN regarding change in condition. Updated Sr Living regarding change. Recommendation to cancel d/c/transfer for today, see how resident does through the weekend and re-evaluate on Monday. Daughter updated on cancellation of d/c today. view 2/4/2021 10:04 Nurses Note Note Text: Daughter aware that resident's O2 sat was 88% on room air on 3-11 shift and that oxygen was applied via nasal cannula. view 2/4/2021 10:03 Nurses Note Note Text: N/O: Discharge 2/4/21 with scripts to Sr. Living. Daughter aware. view 2/4/2021 09:53 Nurses Note Note Text: Pt. to be d/c'd to another facility this am as per MD order. Pt. alert and responsive. Skin assessment done as per facility policy. No pressure areas noted at this time. No s/sx of pain or discomfort observed at this time. V.S. 97.0 67 20 O2 sat 95% with O2 at 2 LPM via n/c. view 2/4/2021 07:45 Nurses Note Note Text: Resident seen by Dr. for discharge. Orders pending at this time. view 2/4/2021 07:36 Nurses Note Note Text: CRNP and Dr. updated on O2 sat 88% on RA with f/u of 93% with O2 on at 2 LPM as well as rest of VS, 3-11 shift 2/3/21. No n/o's at this time. view 2/3/2021 21:17 Nurses Note Note Text: Resident Sp02 88% on RA. Pulse 124. Respirations 40. PRN morphine given and O2 applied via NC at 2L/min. After recheck pulse ox up to 93%, pulse 100, and respirations 22. Resident appears comfortable at this time. view 2/3/2021 20:05 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN Administration was: Effective [linked] view 2/3/2021 19:48 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN given for SOB after elevation of HOB not effective. view 2/3/2021 11:51 Nurses Note Note Text: CRNP updated rapid COVID test done for d/c tomorrow was negative. No n/o's at this time. view 2/3/2021 11:44 Nurses Note Note Text: Daughter notified of rapid covid swab being negative. view 2/3/2021 09:50 Orders - Administration Note Note Text: Obtain Rapid Covid test on 2/3/2021 for discharge. Please give copy of results to Social Worker every day shift for covid testing for 1 Day Completed and negative. view 2/3/2021 08:45 Skilled Nursing Note Reason for skilled service: Therapy describe skilled service: Nursing, therapy assessment: V.S. 97.8 79 18 138/84 Orientation: Oriented to self only. Oxygen: O2 sat 94% on RA Edema: Trace edema noted BLE. Pedal pulses present. Pain: Denies pain or discomfort at this time. Nursing note: Pt. alert and responsive. Skin warm and dry. Lung sounds diminished. No respiratory distress observed at this time. Abdomen soft. BS+ in all 4 quads. Continent/Incontinent of B&B. 1 assist with ambulation, transfers. 1 assist with ADL's. Working with therapy on gait training, therapeutic exercise, therapeutic activities & neuromuscular reeducation. view 2/2/2021 14:37 Progress Note Note Text: Per health professional at Sr Living, prepared to accept patient to their Memory Care Unit 2/4. Transportation arranged for 11 AM per family request. Daughter (POA) updated on d/c time on 2/4/21. Facility requesting rapid COVID test completed prior to d/c and results sent to them. All other information sent for continuity of care.

Patient complained of difficulty swallowing, tingling feeling in her tongue. She initatally took 50 mg of benedryl, and after 15 more minutes, she continued to have the same symptoms, and in addition was breathing more labored, was having a harder time swallowing, and complaining of feeling dizzy and a headache. She then received an Epi Pen, was placed on oxygen, used her Xopenex inhaler, and EMS was called. She was then transferred to the ED for continued monitoring.

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

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.

Bell's Palsy diagnose 2/5/2021 and treated with Prednisone and antiviral. Has history of Bell's palsy in the past. She started with right sided facial droop and was choking with swallowing.

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 5 minutes of vaccination she started to have shortness of breath, and ambulance was called out of caution

1/12/21 er HPI: HPI 78 y.o. female who presents with pain swelling and redness left wrist and hand associated with fever according to EMS, but temperature in the ER is 98.4° F. patient was said to have fallen on 1/7/2021. *incidental finding bacterial pne* 1/12/21 admission History: The patient is a 78 y.o. female with a past medical history notable for Dementia, atrial fibrillation, CHF, diabetes, reflux. The patient presents for evaluation of Worsening issues of decline and trouble with breathing. Patient was evaluated the ER and found to have a urinary tract infection in addition to pneumonia. Due to patient's dementia history is difficult to take outside of history of which was taken for patient's nursing staff at skilled care facility. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed

12:38PM PT C/O 'THROAT FEELS TIGHT-DENIES SOB OR DYSPNEA'. A/O, PINK, W/D, RESP WITHOUT DISTRESS. BENADRYL 50MG PO (1 CHEWED/1 SWALLOWED). 12:52PM 'FEELS A LITTLE BETTER'.RESP REG WITH EASE. 1:35PM STATES 'IMPROVED'. A/O, PINK, PINK, W/D, NO RESP DISTRESS. SUGGESTED TO TAKE BENADRYL 25-50MG AT 4PM AND 8PM THEN A CLARITIN AT BEDTIME. ALSO CHECK WITH PCP R/T DOSE #2. 2-25-21 10AM TC-PT STATES SHE 'FEELS BETTER, BUT THROAT IS NOW DRY FROM CLARITIN'. STATES SHE SAW HER PCP THIS AM AND WAS ADVISED NOT TO TAKE DOSE #2.

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.

2 days after getting 2nd dose of vaccine I became dizzy and queasy and my breathing changed. I spoke with pulmonologist on 3/1/21 and he advised me to start a 5 day regimen of 40 mg. prednisone. I am on day 3 and breathing has been better, not back to normal.

shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264), via an unspecified route of administration at the left arm on 31Jan2021 16:30 at a single dose for COVID-19 immunization. The patient's medical history included atrial fibrillation, pre-diabetic, and high blood pressure. The patient's concomitant medications included sacubitril valsartan sodium hydrate (ENTRESTO) on Oct2020 for heart failure, metoprolol on an unspecified date for atrial fibrillation, and apixaban (ELIQUIS) on an unspecified date in 2018 for blood thinner. The patient experienced shortness of breath on 31Jan2021 20:00. The vaccination facility type was not a military facility. The outcome of the event was recovering.

Patient is a 78 yr/o female who IBS, HDL, GERD, gastroparesis, anxiety, depression presents to the Emergency Department complaining of fever and generalized body ache onset 3 AM this morning. She attributes it to the second Covid shot that she received yesterday. She progressively started experiencing abdominal discomfort which she attributes to gastroparesis. Reports she took Tylenol at 1 PM for body ache with no relief. She also took Zofran for nausea. She had associated diarrhea without any hematochezia. Denies chest pain but has shortness of breath. She did not check her temperature at home. States she had a fever upon arrival to the emergency department. She denies dysuria, hematuria, flank pain. Patient has a history of COVID-19 infection in April 2020.

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.

Cholestasis and Pneumonitis. Improved over 2 months after course of steroids. Noted to be jaundiced about 7 days after vaccine. Liver biopsy demonstrated likely drug injury superimposed on steatohepatitis. Then had worsening dyspnea requiring admission on 2/21/21 for 2 days.

Vaccine was administered at drive through event. During the waiting period, she developed wheezing and dyspnea. She has a history of multiple allergies and self administered her own liquid benadryl 50mg and her own albuterol inhaler. She was also given Depo Medrol 80mg IM. Her symptoms resolved and she was monitored for an additional hour at the site. She had an appointment already scheduled with her allergist later that day and plans to keep this appointment. She had strict instructions to seek medical care immediately if other symptoms developed.

cannot take good deep breaths because of the soreness in her ribs; soreness in her ribs; She had no urge to eat/Has no desire to eat or drink; lost 10 lbs; feel ill; General feeling of the flu; had a slight sore arm; nausea; severe pain, her hip and knee were killing her; was having major problems, a delayed immune response; Rash covering her entire body; acute pain and with deep breaths; low grade fever; cough/Cough was a dry, tight, non-productive cough; Weakness; Chronically dehydrated; the COVID Vaccine wasn't working; the COVID Vaccine wasn't working; This is a spontaneous report from a contactable nurse. This nurse (patient) reported that a 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6204) at the age of 78-years, via an unspecified route of administration on 04Mar2021 at single dose; first single dose of BNT162B2 (lot: EM9810) on 11Feb2021; both for COVID-19 immunisation. Medical history included osteoarthritis (having aches and pains) had for 20 years; large sliding hiatal hernia was diagnosed from an EGD six months before, didn't want surgery to fix it; heartburn (last five years); fatty liver, was not from drinking alcohol; generalized anxiety; was tuberculosis positive only because she was exposed years ago. Concomitant medications included pantoprazole started four to five years before at 40 mg twice a day for heartburn; escitalopram (tablet) been on for 15 years or longer at 10 mg 1 DF every day for generalized anxiety; clonazepam 0.5 mg nightly at bedtime for anxiety (been taking for last ten years or more, stops her from worrying about her kids and stuff like that). The patient experienced on 07Mar2021, low grade fever, weakness, chronically dehydrated and cough; on 15Mar2021, rash, acute pain and with deep breaths; on an unspecified date, no desire to eat or drink. Seriousness criteria of these events were reported as disabling. Patient reported that was having major problems, a delayed immune response. Told everybody if this keeps up she was not going to make it. It was wearing her down and she was not going to survive. Occurred after second COVID vaccine. She is active, goes to pool, and does different things. Had vaccine on Thursday and was ok until Sunday. Started Sunday with low grade fever. Kept being low grade and never got to 101, 102, or 103. She didn't take ibuprofen. Usually takes ibuprofen once a day for routine aches and pains. Having weakness. Had no desire to eat or drink. She waited a couple days, but then called her doctor. Doctor's office wouldn't give her an appointment. Stated this wasn't the routine and has been going on for 10 days. This was too much. Two days later, caller's daughter-in-law took her to a place like an ER. A bunch of tests were done. She asked for an IV because she was chronically dehydrated. Weakness was getting to her. After seeing the doctor in the mini surgical ER, she didn't feel any better. She felt the same. Same nausea, weakness, low grade fever, the whole thing. Decided to see her regular doctor. Stated it wasn't her chest. Wanted to be told what was going on. Her regular doctor didn't order any labs. She was given a steroid shot. Thought she was in deep doo-doo. Stated this was not a good sign and she was not going to make it. She woke up yesterday with a rash covering her entire body. She had no clue she had the rash. Never saw the rash. Rash didn't itch, but she still had it. After steroid shot from doctor, she felt a little bit stronger and thought maybe she was going to make it, but then started getting severe pain. Patient was used to having aches and pains that went along with old age and her osteoarthritis. This was severe pain as if she fell and hurt her ribs. It hurts to take deep breaths. Her hip and knee were killing her. It was acute pain, not normal pain. This morning stated she couldn't take it and was going to take ibuprofen, which was not the best for her. She didn't want to eat, but tried to have food in her stomach to take the ibuprofen. She cannot take good deep breaths because of the soreness in her ribs. Thought something in her body was having a delayed immune response and her gut told her it was not good. For low grade fever, did not take ibuprofen, 07Mar2021 was when she started feeling yucky, she wanted to see how she felt and her temperature never really got up, stuck it out, normal temperature for her was 97 or lower, her temperature once in a while would range from 98 to 100.3 or 100.8, she cannot take paracetamol (TYLENOL). For weakness, noticed right away, felt a little better after steroid, had not been out of her door except to the ER. For chronically dehydrated, clarified she had no desire to eat, usually drinks coffee and tea in the morning, but now had no desire, was making herself drink, felt something wasn't right beginning on 07Mar2021, everything went south and got worse, clarified it really wasn't nausea, but no desire to eat or drink, doctor today gave her ondansetron (4mg) which didn't help and made it worse, eating and drinking didn't make her sick, just didn't want it. She had labs done in the ER and was told her labs weren't really that off for her to be that dehydrated. Asked for an IV because she was not drinking what she normally drinks, didn't feel any better after the IV. Rash covering her whole body, but didn't itch. Acute pain and with deep breaths began evening of 15Mar2021, seemed the same today, she just took an ibuprofen a little while ago and was feeling better. Patient also mentioned that realized her body was trying to get monoclonal antibodies and resistance to build up her immunity so that if she ever got infected with COVID virus she could fight it, it was just not working, it was not doing its thing, she was having a delayed immune response, was very worried about that, going on 8-9 days and it was weakening her by the day, didn't think she could take this too much longer. Clarified the COVID Vaccine wasn't working and her body couldn't get its act together. Patient had a slight sore arm after the second dose, never reacted at the injection sight, it was strictly internal, which kind of scares her, something was not right, was having the rash, pain, and severe weakness. Was not expecting any kind of problem. Didn't think too much about the second COVID Vaccine. Stated people were like "oh that second shot." If she didn't get better soon she is not going to do well. Cough was a dry, tight, non-productive cough, lungs were checked yesterday and were clear, felt like all of a sudden she has an urge to cough and nothing comes up. For steroid shot, didn't know if it was dexamethasone (DECADRON) or not, made her feel a little stronger for the day, but then brought on severe aches and pains in her joints and ribs, did not have this until the steroid shot. Patient said that didn't take ibuprofen the first couple days because she didn't want to mess up the immune response starting in her body, asked doctor about immune globulin for her delayed immune response, but doctor shook his head, knew that people with autoimmune are ordered IGE or IGG to test the immune system, asked doctor about this, but he shook his head. Stated she didn't think a CBC with different was performed at the ER, confirmed she was only in the ER after the second dose and was not admitted to the hospital. As of 17Mar2021, she stated then two to three days after that she woke up with rash over her entire body that showed up overnight, that alarmed her even more of course, no itch or nothing, no clue it was there until she washed off and could see it, she had never had a rash before, her arm never got red, but she had a low grade fever, stated now didn't know if good or bad, cough, not productive, some urge to cough, no appetite, not eating or drinking, and increasing weakness, today she couldn't say anything was different about her rash maybe slightly faded but she didn't feel any better, she did get a steroid shot when she went to doctor yesterday and that made her feel less weak. As of 18Mar2021, patient stated that had no reactions for the 1st 2 days following her 2nd dose however she started to feel ill, low grade fever that never went above 100. General feeling of the flu; aches and pain, which she had before but more than usual. She had no urge to eat. Tried to see her doctor when it had been going on for 5 days but they were not concerned. By that Friday, she went to the hospital. They found nothing wrong in her lab tests but she asked them for I.V fluids since she hadn't eaten or drank anything. On Monday, she went back to her initial doctor because she had a rash all over her body, it did not itch and her injection site had no redness. She was given a steroid shot, today she might be feeling a bit better. She lost 10 lbs. She had to stay inside for the past 10 days, except for doctor visits, although she was usually an active person. She would like to know how long the side effects would last. Outcome of the events low grade fever/ wasn't working, weakness, rash and acute pain and with deep breaths, cannot take good deep breaths and soreness in her ribs was not recovered/not resolved while of remain was unknown. Relatedness per primary source reporter via global introspection of BNT162B2 to events low grade fever, weakness, chronically dehydrated, no desire to eat or drink, acute pain and with deep breaths and cough were related.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered 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.

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.

Wheezing a little bit; Coughing all the time with Asthma; Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: not reported, expiration date: not reported via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 07:00 (at the age of 78-years-old) as single dose for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing Asthma causes patient to have wheezing a little bit, which she has all the time and she also has coughing all the time with Asthma, ongoing diabetes mellitus (Onset date unknown other than more than 15 years ago and is ongoing). There were no concomitant medications reported. The patient experienced tested positive for covid-19 on 14Mar2021, wheezing a little bit and coughing all the time with asthma on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Mar2021 COVID-19 test. The outcome of event tested positive for covid-19 was not recovered and wheezing a little bit and coughing all the time with asthma was unknown. Follow-up activities have been completed and information on the lot/batch number has been requested.

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.

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.

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.

Location of vaccine shot still pink and slightly painful almost a month after shot. Breathing difficulty 3 days after shot was resolved using Benadryl.

tongue was not manageable; throat was swollen; terrible headache; arm started hurting; fever of about 99.9; Feeling sick; stomach starting throwing up and patient was throwing up; started having trouble breathing and could not breath; breathing got worse; I started having trouble breathing and I could not breath; my breathing got worse; could not swallow, could not do anything; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on 15Feb2021 (at around 12:00) as single dose for COVID-19 immunization. The patient medical history included asthma (patient had bad case of asthma, patient had that forever), thyroid (patient takes thyroid pill, natural picked thyroid a 30 mg, takes in the morning) and heart. The patient previously received the first dose of bnt162b2 (COMIRNATY) for COVID-19 immunization (at the age 78 years). Concomitant medication(s) included amlodipine besilate 5mg, cortisone, fish oil, losartan potassium 50 mg, naltrexone hydrochloride 4.5mg, prednisone 5mg, rheumagel, spironolactone 25mg and simvastatin 10mg taken for heart. On 15Feb2021, patient experienced fever of about 99.9, feeling sick, stomach starting throwing up and patient was throwing up, started having trouble breathing and could not breath; breathing got worse, could not swallow, could not do anything and that continued, terrible headache, arm started hurting. On an unspecified date, the patient experienced tongue was not manageable and throat was swollen. The patient mentioned that temperature was 97.7 in the first shot and then it was just 98.2 but on 15Feb2021 it was a little higher. The patient called her primary doctor. The patient took 800 mg Ibuprofen as treatment for fever of about 99.9. The outcome of started having trouble breathing and could not breath; breathing got worse and arm started hurting was not recovered and was unknown for the rest of the events. Information on the lot/batch number has been requested.

"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.

Loss of voice; Asthma; her voice became extremely hoarse; This is a spontaneous report from a contactable nurse. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Mar2021 09:15 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunization. Family history included sore arm. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 (lot number: EN6198) on 23Feb2021 in the right arm for COVID-19 immunization. About 3-4 days after (as reported), her voice became extremely hoarse, in which she lost a voice for 3 weeks. She mentioned that she was diagnosed with Asthma on 23Mar2021 and was started with a Breo Ellipta inhaler. The Breo had a listed side effect of hoarseness of voice in which she started a week after receiving the vaccine, to which her hoarseness became worse. She mentioned that according to the paperwork she received from Pfizer, hoarseness of the voice was also listed as a side effect. She consulted with her Pulmonologist who determined that the inhaler was working pretty well and would like to continue her on it and wanted to see if the hoarseness is still there by May. As of calling, she already has some of her voice back, but the hoarseness was still continuing, which gets worse in the afternoon or evening. She would like to know if this has been reported and for how long it will last. She had the injection/vaccine and hoarseness started about a week before she started on the Breo Ellipta inhaler (NDC: 01730859-10 Lot: UL4F Expiration: 10/2022 Dose: 100mcg/25mcg). She stated they both can cause the same thing with hoarseness. She clarified that when she lost her voice, it was just above a whisper. It had gotten progressively worse since it started a week prior. It lasted almost 3 weeks. Now she has started to get her voice back, but still has the hoarseness and this was as good as her voice gets, it gets worse in the afternoon and by 2:00 P.M. it was back down to no voice. She went down to see the pulmonary specialist and prescribed her 2 different inhalers. The specialist said it was an unusual hoarseness, but he couldn't tell what one it was from. The patient clarified she experienced the hoarseness first from the Pfizer Covid Vaccine after the second vaccine, and then a week later she started on the Breo Ellipta, and the hoarseness got worse. The doctor wants to wait until 19May2021 and see if she still has the hoarseness and then he might switch, but it was working so well, he didn't want to switch her yet. The patient was prescribed Breo Ellipta and Albuterol but she hasn't used the Albuterol. The patient reported that she considers the event as medically significant because hoarseness can cause cancer and she doesn't want it to get worse. No other vaccines administered on the same date of the BNT162B2 and no prior vaccination. The event hoarseness started on 18Mar2021 and loss of voice on 23Mar2021. The events did not require a visit to the emergency room. The outcome of the event hoarseness was not recovered, Loss of voice recovered on 13Apr2021 and asthma was unknown. The events hoarseness and loss of voice was reported as serious-medically significant. Follow attempts are possible. Further information is expected.; 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 serious events Hoarse voice and Loss of voice 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.

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.

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.

WOKE UP NEXT DAY WITH ACHING IN MY LEFT HIP AREA, CONTINUED TO GET WORSE THAT DAY AND NEXT DAY TO THE POINT I WAS HAVING TROUBLE MOVING AND BREATHING BECAUSE OF THE PAIN. EARLY MORNING THURSDAY HAD MY HUSBAND TAKE ME TO ER AS THE PAIN HAD MOVED UP MY BACK ON THE LEFT SIDE. ER TOOK X-RAY AND SAW NOTHING, GAVE ME PAIN MEDICATION, PRESCRIBED PREDNISONE AND THE PAIN STARTED TO SUBSIDE. TOOK PREDNISONE FOR A WEEK AND THE PAIN DISAPPEARED.

1422: Pt reports "ringing in ears and throat tightness" 1422- Pt taken to ER for further evaluation

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

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

Shortness of breath, extremely tired, chills. nausea, feeling unwell, lymph nodes, allergic reaction such as rash, extreme itching, swelling of face, loss of taste and smell, severe congestion upon awakening. PCP is out of town entire month of June. Sick of being sick. Must be remedy to all of this! Am not recommending to my friends. I should have never had second vaccination.

Vaccine recieved 5/11/21 5/19/21 Presented to ED with respiratory failure. Noted bilateral ground glass opacity, respiratory failure 5/25/21 Intubated for respiratory failure with ARDS 5/30/21 Deceased

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.

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.

severe rash/worsened considerably; severe itching; dizziness; swollen tongue; tight throat; even bothering my eyes; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 18Feb2021 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, neuropathy, heart disease, starts and stop date was not reported for all and patient was allergic with sulfa. The patient's concomitant medication(s) included prednisone; gabapentine and unspecified blood pressure medicine, all are taken within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 78-year-old at the time of vaccination), via an unspecified route of administration in left arm on 25Jan2021 at 03:00 pm as a single dose for COVID-19 immunisation. Patient previously took simvastatin and had allergies. On 24Feb2021 at 12:00, the patient experienced severe rash and worsened considerably, severe itching, dizziness, swollen tongue, tight throat, even bothering my eyes. Patient received treatment with benadryl then Zyrtec for all events. Patient not received other vaccine in four weeks of vaccination. Patient visited doctor office/clinic visit for the events. Patient had not covid prior vaccination and not tested covid post vaccination. The final outcome of all events was recovering. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

With the 1st dose of Pfizer vaccine (lot EL9269 IMRA) I had acute onset of A-fib that lasted for 24 hours. I continued to take my heart medication sotalol. With the 2nd dose of vaccine, a few days later I had shortness of breath and difficulty getting a full breath. About 2 and 1/2 weeks later, it was not getting better, so I went to the ER. At the hospital, they took blood work, EKG, MRI of the chest which all came back negative for heart attack and my lungs are clear. I was discharged with instructions to see an allergist. I went to see an allergist and was prescribed an albuterol inhaler and a steroid inhaler which I did not use. It took about 1 more week for my breathing to be back to normal and cleared up on its own.

--2 reactions to report: --After the first dose of Pfizer shot, patient experienced shortness of breath immediately after with tight, constricted throat. An hour later reports having severe chills and fatigue which lasted the next 24-36 hours. This then subsided. --After the second dose, patient reports the same respiratory reaction, but this time also had severe pain in the arm at the injection site, along with heat and redness and itch down the arm. 24 hours later patient reports significant swelling in the right breast (patient was being treated for breast cancer with radiation) went to see dermatologist and other doctor to have it examined. They determined that the breast tissue that had radiation is where the reaction occurred. Doctor described seeing several patients on radiation who had the Pfizer shot report the same side effect. Patient reports the inflammation in the breast took several weeks to fade away, estimates 4 weeks. And now still experiences heat and itch in the arm 2.5 months later to this day.

Received 2nd Pfizer dose at approximately 1:00 pm on Feb2, 2021. t approximately 2:00to 3:00 AM, Feb3, 2021 , I was having difficulty breathing. Went to hospital where I was tested for Covid and pulmonary embolism. Both negative. Diagnosed with extreme micro valve regurgitation. Sent me to Heart Center. First thought I had an underlining heart condition, spent 3 weeks in the hospital under the care of Dr. End result after months of testing. Extreme reaction to the Pfizer shot

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

Colon cancer metastatic; Lung disorder; Kidney stones; Kidney cancer; Vomiting; Pain worsened; Back ache; Thyroid nodule; Lung nodule; sciatica; Nauseous; Light-headed; Feelings of weakness; Difficulty in walking; This is a solicited report from a marketing program received from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular on 29Mar2021 (Batch/Lot Number: ER8733) at age of 78 years old as single dose for covid-19 immunisation; upadacitinib (RINVOQ), oral from Dec2019 (Batch/Lot number was not reported) and ongoing, at 15 mg, once per day for moderate to severe rheumatoid arthritis. Medical history included non-smoker: secondary tobacco exposure, abstains from alcohol, high blood pressure, glaucoma, rheumatoid arthritis, muscle cramps in legs, cholesterol, acid reflux, and dry eyes. The patient had a relevant medical history of osteoporosis, hiatal hernia, DURICEF allergy manifested by pseudomembranous colitis. The patient had secondary tobacco exposure. She had history of usage of Remicade for unknown indication. Concomitant medications included amlodipine taken for hypertension; vitamin D3 taken for supplementation therapy; ciclosporin (RESTASIS) taken for dry eye and glaucoma; latanoprost taken for eye disorder; folic acid taken for rheumatoid arthritis; methotrexate taken for rheumatoid arthritis; magnesium taken for muscle spasms; fish oil taken for blood cholesterol; omeprazole taken for gastrooesophageal reflux disease; all start and stop date were not reported. Solicited report by a consumer of a female with events of colon cancer metastasize to the liver, kidney cancer that possibly moved onto liver, vomiting, back ache, pain worsened, spot on the lung and kidney stones and non-serious lightheaded, felt weak, could hardly walk, nodule on thyroid and right lung and nauseous with RINVOQ (upadacitinib). On unknown dates, the patient experienced kidney cancer that possibly moved onto liver and nodule on thyroid and right lung. On 29Mar2021, the patient experienced lightheaded, felt weak, could hardly walk and nauseous. On 29Mar2021, the lightheaded, felt weak, could hardly walk and nauseous resolved. In May2021, the patient experienced back ache. On 29May2021, the patient experienced vomiting and pain worsened. On 02Jun2021, the patient experienced kidney stones. On 03Jun2021, the patient experienced colon cancer metastasize to the liver and spot on the lung. On 03Jun2021, the vomiting resolved. On 17Jun2021, the kidney stones resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. On 27May2021, she was sent to the emergency room because of back ache and was given prednisone. In Jun2021, she had a terrible back ache. She thought she had sciatica. In Jun2021, she went to the doctor, physician pressed on her back and she went through the roof. She was vomiting and had pain in her back and her daughter took her to the emergency room and did x-ray and cat scans and she had kidney stones and she was having an ultra sound. Went back to the emergency room from 02Jun2021 until 04Jun2021 because of vomiting and pain. She also had kidney cancer that had possibly moved onto her liver. She had an endoscopy done. The biopsy and other tests to decide what was going to happen. There was a nodule on her thyroid and her right lung. She felt ok and had a little backache at times, but she was taking. She already had the COVID-19 vaccines first dose but was advised not to had the second dose because of the adverse events she experienced after the first dose. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 29Mar2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number ER8733. The patient was treated with PREDNISONE. Relevant laboratory and other diagnostic tests included: 17Jun2021 abdominal ultrasound: No more kidney stones; Unknown date biopsy: Unknown; Jun2021 CAT scans: Kidney stones; 03Jun2021 chest X-RAY: Spot on the lung; 04Jun2021 colonoscopy: Colon cancer; 03Jun2021 computed tomography scan: Colon cancer metastasize to the liver; 04Jun2021 endoscopy: Hiatal hernia; Jun2021 endoscopy: Unknown; Unknown date lab tests: Unknown; Unknown date ultrasound: Unknown; Jun2021 X-RAY: Kidney stones. The action taken in response to the events for suspect product upadacitinib was dose not changed. The outcome of events colon cancer metastatic, kidney cancer, and lung disorder was not recovered, events vomiting was recovered on 03Jun2021, kidney stones was recovered on 17Jun2021, light-headed, feelings of weakness, difficulty in walking, and nauseous was recovered on 29Mar2021, events back ache, and pain worsened was recovering, of other events was unknown. Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of colon cancer metastasize to the liver, vomiting, back ache, pain worsened, spot on the lung, kidney stones, lightheaded, felt weak, could hardly walk, nodule on thyroid and right lung unknown onset, nodule on thyroid and right lung unknown onset and nauseous was not provided. The reporter's causality for the event(s) of kidney cancer that possibly moved onto liver with RINVOQ(UPADACITINIB) was no reasonable possibility. (Withheld) opinion is that the events of colon cancer metastasize to the liver, kidney cancer that possibly moved onto liver, spot on the lung, nodule on thyroid and right lung unknown onset and nodule on thyroid and right lung unknown onset are not assessable. (Withheld) opinion is that there is no reasonable possibility that the events of vomiting, back ache, pain worsened, kidney stones, lightheaded, felt weak, could hardly walk and nauseous are related to RINVOQ(UPADACITINIB). The reporter's assessment of the causal relationship of the events with the suspect vaccine 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. No further information is expected.; Sender's Comments: Considering the close temporal association, a causative role of BNT162B2 vaccine for the reported Light-headed, Feelings of weakness, Difficulty in walking, and Nauseous cannot be excluded. All other events are considered unrelated to BNT162B2 vaccine.

tested positive for Covid; shortness of breath; Cough; tested positive for Covid; 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 COVID 19 VACCINE, Solution for injection, Batch/Lot Number: ER8727) intramuscular, administered in Arm Left on 02Mar2021 (at the age of 78-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing hypertension (ongoing). The patient concomitant medications were not reported. The caller states his mom and dad got the first Covid shot, they were due to get second shot today but caller cancelled the appointment, states his mom and dad both hospitalized and tested positive for the Covid virus after the vaccines. Caller states his dad is still in quarantine and mom is done with quarantine, he is hearing different things about when to get the second dose, everyone says to wait 90 days, getting mixed information, then he has heard 3 weeks is long enough to wait. Caller wants to know when his mom and dad can get the second dose of the vaccine after having the Covid infection. The mother got the first dose of the vaccine on 02Mar2021, states on 31Mar2021, she tested positive, caller clarifies his mother was not admitted to the hospital but was seen in the emergency room on 10APR2021 and released later that evening, his mother was told to follow up with the respiratory pulmonologist and remote patient monitoring, been taking oxygen saturations levels with pulse oximeter, shortness of breath and cough on 10Apr2021. The patient visits to emergency room on 10Apr2021. The patient tested positive post vaccination. It was unknown if patient was diagnosed with COVID-19 prior to vaccination, other medications in two weeks and other vaccine in four weeks. The patient received unknown treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Mar2021. The outcome of the event tested positive for Covid was unknown and rest events outcome was not recovered. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.

Patient started to have trouble breathing around February 10th. She also complained that she couldn't swallow very well since the 2nd vaccine on February 2nd. On February 12 she called in a panic. Her lips were swollen and then her tongue started to swell. I took her to the ER where they sent us to a large hospital. They ran all sorts of test. Blood work, CT Scan, ultra sound. No one could tell me why this was happening. They gave her antibiotics and steroids and the following morning on February 13th she was discharged. The next morning on February 14, patient called me again in a panic. She couldn't breath and couldn't swallow. Her lips, tongue, and under her chin were swollen, hot, and hard as a rock. I rushed to get her and took her back to the hospital. She was in the ER for about 8 hours where she was almost intubated as her airway was close to closing off. She was moved up to the ICU that day and stayed in the the ICU until February 19th. During that time, they ran all the same tests, blood work, CT Scan, ultrasound and no one could tell me why my mom was having this reaction. After we returned home I received a call from the ICU doctor who was checking on her as they had more patients come in with the same symptoms post covid - vaccine. She advised to file this reaction with all the information I had and told me that patient was not to get the booster if one was required later.

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 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 AFTER VACCINATION :SWOLLEN LIPS,DIFFICULTY SWALLOWING ,SENSATION OF THROAT CLOSURE, DI FUSE RASH (ARMS ,LEGS ,BACK) ,SWOLLEN NOSE AND FACE AREA AROUND.

Cough, shortness of breath, fatigue, body aches, headache, runny nose, congestion Today 1-30-2021 headache is finally gone, lingering cough, congestion is better, some aches in my shoulders

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.

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.

Pt began experiencing feeling "short of breath" pt is double masked. Pt removed mask and did a couple deep breaths and felt slight improvement but s/s returned. Offered and pt accepted cold water, alleviating feeling short of breath. 5 pm pt began feeling more short of breath and was breathless w/speech. Nurse alert called and PO benadryl 25 mg in 10 ml PO given lot c13e exp 3/21. Vitals taken 145/745 56 HR and 95 O2. Pt taken to advanced urgent care by staff via wheelchair 507 pm

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.

sore throat stuffy nose shortness of breath cough ; saw dr. got z-pack ; clear 6 days later; inhaler 5 days; prednisone 10 days

Involuntary shudders I had no control over that lasted 4-5 minutes that left me gasping for my breath. Left arm is quite red and very warm. I was down all day Wednesday & most of Thursday. It so happened that I had a scheduled appointment with my cardiologist on Thursday and checked ok

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

Client reported on 2/17/21, at approximately 9:30am, she had shortness of breath that started at about 5:00am. Client was clearly in mild respiratory distress. She was able to walk and talk, although those activities exacerbated shortness of breath. Asked client and spouse if they would like me to call ED; and both declined. Referred to nearest ER. Spouse reported he would take her to the ER. Assisted client to car and client left with spouse driving.

grade 2 allergic reaction; short of breathe; flushed; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; she was an oncology patient with large granular lymphocytic leukemia and received BNT162B2; This is a spontaneous report from a contactable other healthcare professional. A 79-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9262, NDC number of COVID Vaccine: 59267-1000-1; Expiry Date of COVID Vaccine: 31May2021), intramuscularly at Left Deltoid on 08Feb2021 10:30 (either 10:30AM or within that hour or prior) at single dose for COVID-19 immunization. Medical history included anxiety, panic disorder, asthma, obstructive sleep apnea, additional Information for Other Conditions: She was oxygen Dependent, coeliac disease, allergy, Additional Information for Other Conditions: She had Medication, Environmental, and Food Allergies, central neuro hearing loss, vertigo, Allergic rhinitis, gastrooesophageal reflux disease (GERD), Additional Information for Other Conditions: Esophageal Reflux, osteopenia, impaired glucose tolerance, hypothyroidism, claustrophobia, rheumatoid arthritis (she had arthritis for which she took Orencia for), history of coronary heart disease, diabetes, she would be a targeting patient, as she was an oncology patient with large granular lymphocytic leukemia she met criteria for the pandemic, as well as they put down that she was due for immunization. She had anaphylaxis to bees. With adhesive tapes she got dermatitis. With shellfish she got hives. She had a gluten sensitivity and with mango her mouth gets fuzzy. Family Medical History Relevant to AE(s): her sisters had a few cancer. There were no concomitant medications. The patient previously received levofloxacin she had hives, with quinolones drug class she had hives, with thiopental she had hives and needed IV Decadron for it, with sertraline she has syncope, with Revatio she had an adverse event of joint and muscle pain, with ciprofloxacin she had tachycardia, with Enbrel it caused a drug induced pulmonary fibrosis granulomatosis, with Montelukast she had a headache and muscle pain, nitrofurantoin she had headache, with Symbicort it gave her hoarseness, she took Orencia for arthritis, she got the flu Vaccine in Sep2020. That was most recent. The patient had a grade 2 allergic reaction on 08Feb2021. The patient was watched after administering the vaccine on 08Feb2021 as she had background of multiple allergies and asthma. She was watched for 30 minutes in the oncology unit infusion suite. The reaction happened within 5 minutes of administration. Seriousness Criteria: Caller explained that this reaction was mild to moderate, there was a grade to intervene but at no point was she unstable, she did have a significant anxiety disorder, and so she was nervous about getting the vaccine. She was short of breathe, odd and flushed. She was physically stable, her vitals were stable and there was no angioedema. Reporter seriousness for grade 2 allergic reaction: Medically significant. The patient recovered, as a treatment they gave her IV Benadryl 50mg and IV fluids, she also had her own albuterol inhaler. In the pandemic, they are not doing nebulizers. The outcome of events allergic reaction, shortness of breath and flushed was recovered on 08Feb2021. Relatedness of drug to reaction(s)/event(s). Reaction assessed: Grade 2 allergic reaction; Source of assessment: Primary Source Reporter. Method of assessment: Global Introspection. Drug result: Related. Causality: reporter stated that she did think the patient's base line anxiety played into the reaction she experienced, the reaction was aggravated by it.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of grade 2 allergic reaction, short of breathe and flushed due to temporal relationship and current known drug safety profile. The patient's underlying allergic physique also predisposed the patient to developing the event. 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.

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.

I experienced throat congestion:a feeling of thickness and swelling.; I experienced throat congestion:a feeling of thickness and swelling.; higher temp; arm ache; This is a spontaneous report from a contactable consumer for herself. A 79-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on 30Jan2021 14:30 (Lot number: EL9264) via an unspecified route of administration in the right arm at single dose for COVID-19 Immunization. The patient's medical history included cholesterol but not high. The patient had no known allergies to medications, food, or other products. The patients concomitant medication included rosuvastatin at 5mg, aspirin (acetylsalicylic acid) at 81mg. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination and was not tested after the vaccination for COVID-19. The dose was received at 2:25pm. The dose was received on adverse event start date: 30Jan2021 at 2:25pm. patient waited the 15 minutes waiting period & went home. 95 minutes after (30Jan2021 16:00 PM) the injection she experienced throat congestion: a feeling of thickness and swelling. The symptoms lasted 35 minutes. Other reactions were normal: higher temp & arm ache. There was no treatment received for the adverse events. The outcome of the events was recovered on 30Jan2021 16:35. No follow-up attempts are possible. No further information is expected.

short of breath taken to ED. At home- Had aphasia after 1st dose for about 5 minutes. PCP said to get 2nd dose

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 presented with dyspnea and found to have COVID 19 infection. Treated with steroids and oxygen but clinically deteriorated and died

C/O SOB with walking within observation room Assessment: Vitals: B/P: 162/100 HR: 57 Resp.: 16 O2Sat: 95% Skin Signs: Warm and Dry, pre existing dermatitis skin rash on arm, les to chest Circulation: Cap Refill <2sec Resp.: Other- diminished with few rals at base Treatment: Observation Repeat Assessment: 13:43 Vitals: B/P: 168/98 HR:55 Resp.: 16 O2Sat: 93% Skin Signs: warm and dry Circulation: Cap refill <2sec Treatment: Pt monitored, states feels better, no SOB, no wheezing, pt stable, pt d/c'd home with instructions to call 911 for and exacerbated symptoms

8 days after vaccine, patient presented with headache, severe body aches, fever, chills, and fatigue. Patient had a patchy right upper lobe infiltrate, pulmonary infarction was ruled out.

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.

delirious; could not even form a thought; Dry cough; difficulty breathing; vomiting; 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 at the age of 79-year-old, administered in Arm Left on 23Feb2021 13:30 (Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included hypertension, glaucoma, and COVID-19. The patient had no known allergies. The patient was not pregnant. Concomitant medication included amlodipine taken for an unspecified indication, start and stop date were not reported; latanoprost taken for an unspecified indication, start and stop date were not reported. The patient experienced delirious, could not even form a thought, dry cough, difficulty breathing, vomiting on 24Feb2021. Adverse event: February 24; All side effects listed by CDC except vomiting, also had dry cough, difficulty breathing and delirious (could not even form a thought). No treatment received for the events. The outcome of the events was recovering. The event delirious was considered as serious (medically significant). No other vaccine in four weeks. The patient was diagnosed with COVID prior vaccination. Not COVID tested post vaccination.

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.

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).

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.

The day after receiving vaccine (2/19) she experienced shortness of breath while shopping at store. She returned home without incident. She thinks she took a Benadryl because that is her usual response. She took a shower on 2/20 and her torso turned bright red from neck to waist - she remembers taking a Benadryl for this - the redness disappeared within about 20 minutes and has not returned. She called her doctor on Friday, possibly Monday she thinks. The MD office called and had her come in on Monday 3/8 for an evaluation. The SOB continues even now. It is worse with activity.

Blood clot in lung; Shortness of breath; Felt tired; Slight headache; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201), dose 2 intramuscular, administered in Arm Right (also reported as "injected intramuscularly in right arm") on 23Feb2021 13:00 (at the age of 79years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL8982) on 02Feb2021 (at the age of 79years) for Covid-19 immunization. Medical history included high blood pressure (diagnosed prior to 10 years ago), respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities including diabetes, diagnosed allergies, compromised immune status, and obesity (Little on the heavy side but she does not think she is obese); all from an unknown date and unknown if ongoing. Concomitant medication included lisinopril taken for high blood pressure at 20 mg once daily, started at least 10 years ago. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had received the two doses, she had shortness of breath in the morning around 08:30 on 08Mar2021 and went to her doctor. They did blood work and she was put in the hospital because the doctor found out she had blood clots in her lungs (11Mar2021, 13:00). The patient was hospitalized for blood clot in lung from 11Mar2021 to 13Mar2021. She doesn't know if it came from the vaccine or not. She was sent home on Eliquis for 6 months to get blood clots from her lungs. She also has oxygen for when she needs it and mostly for when she is ambulatory. It was further clarified that when she went to her doctor's office, they did blood work. When they got results, they called her at home and told her that she had to call the ambulance and go the hospital in the ambulance, so she did; Ambulance to ER (hospital) on 11Mar2021. There was also a problem with the left ventricle of her heart (12 Mar2021 12:30). She stated whichever part pumps blood into the pulmonary vein, something is wrong there. She was going to have an echocardiogram to check that out again on 29Apr2021. She does not know the outcome of that yet until she gets that done. They gave her Eliquis as a blood thinner and oxygen. She has not really needed the oxygen around the house. But if she goes outside, she may. She took it to the grocery store with her and if she needed it, she used it. She also had a headache after second dose on 24Feb2021 09:00. She felt tired on 24Feb2021 21:00 and stuff (as reported). The outcome of event blood clot in lung was unknown; the outcome of other events was recovering.

"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

Mouth inside cheeks inside lip area., raw thicker,, slight burning on left side corner of the lips and inside left side to upper. Worst started April 30 with immediate swelling including change in throat. Took Hydroxizine. The throat got better aware of inside mouth swollen.

pt says she started having trouble breathing so went to an Urgent Care where she was told she had allergies and prescribed some allergy medication. She continued to decline so on 4/28/21 she went ER. They did Chest X-Rays and other test and was diagnosed w/ blood clots in both lungs. She was admitted and stayed overnight. She was released and told to FU w/ Pulmonologist on 5/4/2021 @ 1 PM.

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

Swelling of my tongue and throat. The second and third days I was unable to stand or walk without assistance and was extremely tired and also had memory lapses.

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.

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.

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,

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

shortness of breath; experienced white and pink bumps on her face around her lips; experienced white and pink bumps on her face around her lips; she experienced aches and pain in her joints; blurred vision on and off; This is a spontaneous report from a non-contactable consumer (patient). A 80-years-old-female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 (79-years-old) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient did not have her medications, but she did state that she has had several Botox injections in the area on her face where she experienced the reaction. The 2nd day after the first dose of the vaccine (24Feb2021) she experienced white and pink bumps on her face around her lips. She also had some shortness of breath and called 911. She was admitted to the hospital. The ruled out COVID infection and Pneumonia. On the 3rd day while hospitalized she experienced aches and pain in her joints. She was discharged after 3 days. Her symptoms have subsided. She is only complaining on some blurred vision on and off. She received her first dose on 23Feb2021. Her Doctor told her she should not get the 2nd dose. Therapeutic measures were taken as a result of shortness of breath, experienced white and pink bumps on her face around her lips, she experienced aches and pain in her joints. The outcome of event she experienced aches and pain in her joints was recovering, while other events was unknown. It was reported that patient had several Botox injections in the area on her face where she experienced the reaction. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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.

I started feeling tired later on that afternoon and in the middle of the night I started having chills and fever. The very next day I was so weak I couldn't get out of bed and was having a hard time breathing. I called 911 and was taken to the hospital which resulted in being admitted.

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 was found unresponsive "guppy breathing" at home on 6/7/2021. Intubated by EMS at home, administered rapid SARS-CoV-2 test in field which resulted as positive. Admitted to ICU on ventilator. Remains in same condition as of reporting date (6/10/21).

Pt w/hx significant for COPD (on 1L O2 a baseline) p/w cough, exertional dyspnea, and generalized weakness since 6/7/21). COVID test positive on 6/10 despite receiving Pfizer vaccines on 4/5 & 4/27. Pt was admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. During admission received dexamethasone, convalescent plasma, remdesivir. Culture indicated pseudomonas PNA, but likely colonization given hx, however, due to illness and underlying bronchiectasis, was given cefepime. Hospital stay complicated by significant resistant hypercarbia and respiratory failure, pt placed on comfort measures given that death is imminent. Unfortunately, pt passed on 6/13/21.

loss of apatite/can't eat anything- everything tastes like soap; diarrhea; fatigue; body aches; difficulty breathing; congestion; feel sick; chills; cough; headache; This is a spontaneous report from a contactable consumer. This 79-year-old female consumer reported for herself that: A 79-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ENG198, Expiration date: Unknown), via an unspecified route of administration with a needle into left upper arm on 06Mar2021 at 9:30 (at the age of 79-years) as (exact dose unknown) single dose for covid-19 immunization. The patient medial history included ongoing neuropathy pain, ongoing asthma (diagnosed when she was a kid), ongoing bladder problem/bladder infections (she kept getting bladder infections; went to a bladder specialist 6 months prior), ongoing high blood pressure (diagnosed for many years), ongoing arthritis (diagnosed for many years) and knee replacement in 2008. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect, was not administered additional vaccines on the same date of the Pfizer vaccine, and did not receive any prior vaccinations within 4 weeks of Pfizer vaccine. The patient had no family history relevant to the adverse events. Concomitant medications included gabapentin (been taking that for years) from an unspecified date to ongoing for neuropathy pain, losartan potassium (been taking this for years) from an unspecified date to ongoing for high blood pressure, nitrofurantoin (MACRODANTIN) (about 6 months) from an unspecified date to ongoing for bladder infections, beclometasone dipropionate (QVAR REDIHALER) (been taking this for years) from an unspecified date to ongoing for asthma, Serevent Diskus (been taking this for years) from an unspecified date to ongoing for asthma, estradiol vaginal cream usp (about 6 months) for "bladder" (bladder disorder), and ibuprofen (if she needs it, but she doesn't always need it). The patient stated she was taking her usual medications-allergy medications, high blood pressure medicine and estrogen. The patient's historical vaccines included shingles vaccine in 2019 with sore arm as the reaction, pneumonia vaccine in 2019 with sore arm as the reaction and tetanus vaccine in 2019 with sore arm as the reaction. She did not have NDC/LOT/Expiration number of the historical vaccines. On 19Mar2021, the patient began to feel sick. She reported the following symptoms: chills, cough, headache, difficulty breathing and congestion starting on 19Mar2021 around noon time, fatigue and body aches starting on 20Mar2021 gradually throughout the day, and loss of appetite/ "can't eat anything- everything tastes like soap" gradually throughout the day and diarrhea starting on 21Mar2021. She thought it was going away, but it didn't. She stated that when the chills first started, she couldn't even hold her hand still, but that had improved. She stated that everything tasted like soap on the third day of the symptoms' onset on 21Mar2021. She stated that she made herself eat a little, but she just couldn't. She stated that she drank as much water as she could. She stated that the taste of soap was there before, but she didn't recognize it for what it was until it started to get worse. She stated that she needed to get her glasses to read the writing on her vaccination record card. She started that she did not want to get the second dose on Saturday, 27Mar2021. The patient inquired what she should do. She stated that to be able to talk on the phone, she had to take paracetamol (TYLENOL) 650 mg, and she had taken one tablet. The patient did not require emergency room or Physician office visit due to the events. She thought it would go away, so she didn't go see her doctor. Treatment received for the events included paracetamol (TYLENOL) 650 mg. The patient had undergone no investigations or relevant tests. The outcome of the event fatigue and loss of appetite was worsened. The outcome of the events difficulty breathing, body aches and diarrhea was not recovered. The outcome of the event chills, cough, headache and congestion was recovering. The outcome of the event "feel sick" was unknown. No follow-up attempts are possible. No further information is expected.

calcified lump, left breast, inconclusive; weak; tired; chills; shortness of breath; Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear); Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear); lung nodule; This is a spontaneous report from a contactable consumer (patient). A 79-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EN5318), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 as single dose for covid-19 immunization at Hospital. Medical history included atrial fibrillation, mitral valve stenosis, COPD (chronic obstructive pulmonary disease), ,ggo's , asthma, Known allergies to various medications. Concomitant medications in 2 weeks included Atenolol, Digoxin, Atorvastatin, Eliquis, Lasix, k (Potassium). Patient did not receive any other vaccine in 4 weeks. Patient did not had COVID prior vaccination. Patient did not tested for COVID post vaccination. Patient previously received COVID 19, brand: Pfizer-BioNTechCOVID-19 Vaccine 1st dose in left arm with lot number EL3246 on 21Jan2021, at 10:45. In Feb2021, the patient experienced lung nodule. On 19Feb2021 at 10:00 patient had chills. On 19Feb2021, the patient had Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear). On 19Feb2021 at 10 PM the patient had shortness of breath, abating at 4 am. On 20Feb2021, the patient was weak and tired but beathing easily. On 02March 2021, the patient had calcified lump, left breast, inconclusive. AE resulted in Doctor or other healthcare professional office/clinic visit. Lab test included patient had CT scan of lungs on 03Feb2021. On 05Feb2021 mammogram was done. On 09Feb2021 PET scan GGO change, upper left lobe confirms solidifying. On 02Mar2021 repeat mammo, results calcified lump, left breast, inconclusive. Bronchoscopy was scheduled for biopsy of GGnodule on 18Mar2021. On 19Feb2021 weight at 9 am was 127.5 lbs. On 21Feb2021 weight at 9 am was 120.0 lbs. Itchy lumps disappear 1 week. Treatment received was repeat mammo and biopsy of lung nodule. The patient was recovering for all the events while Itchy lumps at the site of previous shingles ((rt. forehead to rt. ear) was recovered. No follow-up attempts are possible. No further information is expected.

Chief Complaint Patient presents with o Shortness of Breath HPI 79 year old female patient with a history of hypertension and diabetes presents to the emergency department with complaint of dyspnea since March 3. Patient states that she received her first COVID vaccine last week and felt like she initially had mild chills. No fever, denies chest pain or leg swelling. Patient notes her symptoms have become progressively worse over the past couple days, she has been uncomfortable at night sleeping. She states she feels short of breath all the time, even at rest. Assessment: 79 year old female patient presents to the emergency department with complaint of worsening shortness of breath for over one week. Differential diagnosis: Pneumonia, hypoxia, acute respiratory failure, CHF, flash pulmonary edema ED Course and Disposition: Patient received about 1 min of therapy from a duo neb treatment and became increasingly anxious and hypoxic. Patient became progressively more anxious and was unable to keep non re breather mask on. SpO2 in the low 80s patient anxious stating "help me, give me a tranquilizer", unable to speak in full sentences and acutely confused. Patient was intubated by Dr. for acute respiratory failure, tolerated well. BP and HR improved after labetalol. Chest xray showed patchy opacities suspicious for viral or atypical bacterial pneumonia. Clinical presentation and acuity of condition concerning for flash pulmonary edema. COVID negative. Treated with Rocephin and doxycyline to cover pneumonia. IV lasix given for diuresis. Patient will be admitted to the ICU. I had a detailed discussion with the patient's daughter regarding the historical points, exam findings, and any diagnostic results supporting ICU admission. Based on the patient's history, exam, and diagnositic evaluation, there is indication for further emergent intervention and inpatient treatment. Discussed case & plan with Dr. who also independently evaluated the patient and agrees with the course of care and plan. Critical Care There is a high probability of imminent or life threatening deterioration due to respiratory failure. Acute interventions include develop tx plan w/pt or surrogate, eval pt's response to tx, documenting the case, initial hx & physical exam, order & review of radiology studies, order & perform tx & interventions, re-eval of pt's condition and vent management.

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.

tightness in her throat; shortness of breath; her right arm was aching and went up into her shoulder and neck; This is a spontaneous report from a contactable consumer or other non hcp. A 79-year-old female patient received bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration in the left arm on 01Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history included food allergy allergies to soy, drug hypersensitivity, allergies to antibiotics, drug hypersensitivity from an unknown date and unknown if ongoing allergies to blood pressure medications and the patient had lung problems, she does not have COPD, but she has bacteria in her lungs called MRSA. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced tightness in her throat, shortness of breath, her right arm was aching and went up into her shoulder and neck. She checked her oxygen levels, and they were fine, so she did not go to the emergency room. The patient was due for her second dose next Monday. Therapeutic measures were taken as a result of tightness in her throat, shortness of breath, her right arm was aching and went up into her shoulder and neck. The patient took a breathing treatment and it helped some and had Benadryl and had going into deep sleeps at times. The outcome of the events was unknown No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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 can't lift anything/Patient states she couldn't even roll over in bed, she just laid there like she was dead; muscle and body pain; body pain/ in a lot of pain; shortness of breath; headaches; lightheadedness; weakness; tiredness; chills; joint pain; nausea/Really Bad Nausea; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; weird bumps on her arms that were itchy but now are not; sore throat; she feels like her throat and neck is swelling and tight; weird bumps on her arms that were itchy but now are not/weird bumps on her arm; bone pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0171) via an unspecified route of administration, administered in Arm Left on 09Jun2021 (79-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included ongoing she is disabled and has been disabled for 27 years. Patient states she lost 14 pounds in the last 3-4 weeks, but that was before the shot. The concomitant medications were unspecified. Historical vaccine included flu shot When she gets the flu shot, she can get symptoms for about a week. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. No prior vaccination within 4 weeks. The reporter reported that, she received her first dose of the Pfizer Covid-19 vaccine on 09Jun2021, and then on 10Jun2021 she experienced Muscle and Body Pain, bone pain, sore throat, shortness of breath, headaches, light headedness and dizziness Really Dizzy; didn't know if she was walking forwards or backwards, Weakness; she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it; couldn't hold a pencil, tiredness, chills, joint pain and in a lot of pain, and Really Bad Nausea. The reporter stated that when the patient lays down it feels like her throat and neck are swelling and tight, and she also has weird bumps on her arm, the itching is gone but she can still feel the bumps. she couldn't even roll over in bed, she just laid there like she was dead. The reporter stated the patient is not getting the second dose and not going to the hospital. The reporter asked how long do these symptoms normally last, it's already been two weeks. The reporter asked, "If she can't take the second shot, can the doctor give her a clearance for that, Some places are forcing people to take this." Patient is in the background on speakerphone and states she is not going to the hospital, so forget that. The reporter stated the patient also has weird bumps on her arm, the itching is gone but she can still feel the bumps. The reporter stated that the side effects started on 10Jun2021. Patient states the bone pain lasted a week and a half and then every day something new came, they were kind of sporadic. Patient stated that she has the bumps on her arm, and everything except vomiting, if vomits she is in trouble. Patient states her bones are better some, but the weakness is there, she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it and she still gets dizzy. The reporter stated there are so many different side effects that they are unsure of when each one started and stopped, but most of the side effects are ongoing. Patient stated there is no way anyone will get her to go to the hospital but she just wanted to know how much longer is this going to go on. Patient stated last night she didn't know if she was walking forwards or backwards and she was so weak she couldn't pick up a pencil. Patient stated in the morning she thought she is still alive, she couldn't believe it. Patient stated she will not have the second shot, she cannot. Patient states she can't go through that again, she would rather die. Patient stated she couldn't even roll over in bed, she just laid there like she was dead. Patient states she has had a hard life but never like this. Patient stated she takes a lot of medications but she has been taking them for years and there are no medications or medical conditions that she feels are relevant. No treatment received for events. The outcome of the event muscle and body pain, body pain/ in a lot of pain, weird bumps on her arms that were itchy but now are not, bone pain were resolving and events were not resolved. Information about lot/batch number was provided. Additional information has been requested.

24Hr, 01/09/2021-post vaccine found in room on floor- very shaky and SOB, again later the same day-incontinent urine, confused, pain in extremities with movement, sent out to hospital. returned same evening. 01/12/2021- difficulty communicating, confused- sent out to hospital, returned same day. 01/15/2021- symptoms improved

1/15/21 at 9:54 am was alerted to observation area. Client attended by EMS. Client stated she was having shortness of breath. Client had removed her Oxygen that she usually uses. Client stated she felt better and was released to go home with her son.

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.

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

waited the standard 15 minutes. then left on way home started to wheeze. Got home and wheezing getting worse. Used my inhaler help and feeling more comfortable. But wheezing continued thru to the next day. Using my inhaler as prescribed for my allergy conditions

0934 am: per pt. daughter, pt reports SOB and dizziness. Pt. is slow to answer questions, EMT arrival 0939 am VS: BS 115, BP 154/73, REsp 19, HR 96, O2 98%. Rev BP: 124/73, HR 70, O2 95%

No adverse reactions noted. Resident is on hospice for end of life care for terminal diagnosis cerebral atherosclerosis. Experiencing respiratory distress 2/10/2021 r/t to hospice prognosis.

Asthma attack with wheezing, coughing, shortness of breath. Used an albuterol inhaler. Still currently having symptoms.

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.

Asthma attack began about 20 minutes after injection, with throat tightening, slight mouth swelling sensation and immediate wheezing which grew progressively worse. I had my inhalers (Levalbuterol and Flovent) with me, used Levalbuterol at the direction of medical people who surrounded me after I reported wheezing. They gave me a Benadryl, then brought a wheel chair and sent me directly to the ER. I was there about 3 hours during which I had a heart monitor, a "breathing treatment" by a respiratory therapist, and DUONEB, famotidine (PEPCID), and (DELTASONE). I was given a 3 day Rx for 20 mg. of prednisone, and released. My lungs felt "twitchy" the next day and my voice was muted, but was well otherwise. The only "normal" side effect I had was some soreness at the injection site for a couple of days, with some light sensitivity there for a few weeks.

trouble breathing; This is a spontaneous report from a contactable consumer. A 80-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), by injection once to upper right arm on 21Jan2021 at single dose for prevention. The patient medical history and concomitant medications were not reported. The patient experienced trouble breathing on 24Jan2021 with outcome of unknown. She got the vaccine shot last Thursday, later clarified as COVID vaccine, and she has read over the factual sheet given after the shot, she read it once quickly, will she be ok? She has difficulty breathing, one medication, she has that too, but not more often, with this she has been having it more often, she sleeps well during the night, it is just during the day. That was a severe reaction, two days ago or so, she can breathe sometime, but it's during the day, she read one dose effects say severe reaction, and it also says. she should have been given this paperwork before the vaccine, she didn't need it, she did not have an emergency, unless the second shot will be more helpful than one shot, after 3 weeks she gets another one. It says to call vaccine provider or healthcare professional if you have any effects that bother you or do not go away, how long do you wait until it doesn't go away? Why do they give the paperwork, why don't they give it at the doctor's office office before you set up an appointment to get vaccinated? Before so you can sit down and read the paperwork, she probably would not have gotten it, it says it is only only for emergency use for 16 and over, is this still a clinical trial, that information is not provided, and that burns her behind. She got the shot and 3 days later had the difficulty breathing, so she got it last Thursday, then started Sunday, Monday, into Tuesday, and it's just not. (caller did not complete sentence). Reporter email address declined. She hasn't told her doctor yet, provider's address and email address unknown. She thinks it started on Sunday, it wasn't yesterday, she thinks it was Sunday off and on, sometimes during day she can catch her breath, it may not be this or something, which is what she wants to find out, she is concerned with the idea this should not be sent out, she would not have gotten it. Has Pfizer received many calls about this, about the paperwork? It says it has not been approved, she would never have gotten it, it says only for emergencies, she doesn't have an emergency, this should have been given before the vaccination, it is probably still under clinical trial, but they are saying on TV everyone should be vaccinated, it is either up or down, yes or no, a see saw, yes they do something, then no, it's controversial, some part of paperwork says yes. Her breathing is not worse, this says it may go away in a few days, it says if it bothers you or does not go away, how long does she wait? It says severe reaction she doesn't understand, if it goes away, it doesn't bother her health, then goes away because of the vaccine inside, ok, once she got the vaccine, she had to stay in a room for 20 minutes or so, she had to stay in a room if she had a reaction. Her vaccine card says first dose, then says the hospital, she can't really read it, they write so quick. Says 11Feb2021 is her second dose She read in there, if you have an allergic reaction to other vaccines, she said no, this was her first reaction.

She had the Pfizer vaccine of Feb 1st and then a bladder botox injection of Feb 2nd at 915am. At 2pm on Feb 2nd she started to feel "absolutely terrible" with extreme fatigue ,mental fogginess and throat pain with tightening sensation in her throat. it has gradually "gotten a bit better" but she still has these symptoms.

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.

Had shallow breathing; Very weak; Could not walk; Disoriented; Wanted to sleep; Incoherent; couldn't/wouldn't eat; Dehydrated; This is a spontaneous report from two contactable consumers (primary reporter was patient's husband). An 80-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included ended up in the hospital for 2 weeks with pneumonia and COVID-19 at the end of last Summer. The patient's concomitant medications were not reported. The patient's husband reported that the patient received the first Covid shot about a week to two weeks ago. She went to the facility and got the shot and was fine afterwards until she came home. Later that afternoon, she started showing symptoms of problems, was weak and couldn't walk, disoriented, wanted to sleep, was incoherent, couldn't/wouldn't eat, was very, very much having trouble, shallow breathing. He tried to stay right her and eventually it got to be scary for him with her shallow breathing. He ended up calling an ambulance and she went to the hospital. They gave her tests and was there until about 4 or 5 in the morning before she started showing signs. She was dehydrated was a part of it. The tests were showing the symptoms were improving and she was beginning to come out of it fortunately with doctor's care because he didn't know what to do. He had been going through materials and she is coming up on another shot next Monday and does not want her to go through that if it can be helped. She was coming up for the second shot. Saw something on the tv that rattled him to his bones. It had been found that people who had Covid virus previously and then got the shot may not need a second shot. He is trying to flush that out to whether or not that is something or not that she should be considering. They have the card to go back to the same place for the second shot and they are trying to figure if they need to set up an appointment now. Hoping that this was the worse of it and it is hard for them to call back and his physician is not an expert on this and he got Pfizer's office contact number and decided to call. Outcome of the events was recovering. Information on the batch/ lot number has been requested.

Second dose adverse events: Extremely horrid headache, chills and low grade fever, fatigue, sore arm. Slept almost all day and all night of the second day. Second dose-second day: Headache almost gone but very sore eyes, the arm was better, fatigue lingers, and noticeably breathless. Later but don't remember exact day; Rt jaw bone by the ear sore; hard to open my mouth to eat. This side had the Bells Palsy in 1996.

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.

symptoms, Shortness of air, sat 93% room air, cough, headache, diarrhea. exposure to positive family member approx. two weeks prior to office visit on 03/01/2021, was scheduled for Monoclonal antibody treatment.

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

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.

- 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.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Medium, Systemic: Shakiness-Medium, Additional Details: Patient reported allergy to flu vaccine, asked for reaction and she did not report anaphylactic symptoms. Patient told that we will watch over her after receiving the vaccine. About 5 minutes later, swelling on back of the neck reported and gave Benadryl 25mg. Later reported difficulty swallowing and administered 1 dose of 0.3mg epinephrine. Daughter called 911, after arrival patient reported feeling better but still taken to ER. Daughter said she felt better at ER.

Inability to get a full breath; shortness of breath; difficulty breathing and trying to move about. Condition slightly improved but continues.

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 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.

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.

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

Immunotherapy was no longer working/had another mass; Immunotherapy was no longer working was reported as worsened/had another mass; Having more issues with breathing; emphysema; This is a spontaneous report from a contactable consumer (patient). An 80-years-old female elderly patient received bnt162b2 (PFIZER-BIONTECH COVID-19, Solution for injection, Lot Number: EN6201, expiration: not reported), intramuscular, administered in arm left on 18Feb2021 at 18:00-18:30 as second dose, single for covid-19 immunization(at the age of 80years). Medical history included cancer. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. Other and family medical history was none.Concomitant medications included prednisone -1mg daily; was a higher dose back when she started and was now decrease,) taken for polymyalgia from Oct2020 to an unspecified stop date; pembrolizumab (KEYTRUDA) taken for Stage 3 Lung Adenocarcinoma (non-small cell) from 02Jan2021 to an unspecified stop date, infused once every 3 weeks; received infusion at chemotherapy center; no sample of the product available to be returned, packaging sealed and intact. Previously, the patient received historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Lot EL9265, expiration was unknown) injected intramuscularly, administered in upper arm left on 28Jan2021 as first dose, single for covid-19 immunisation , barely felt it and no adverse event following prior vaccinations. The patient received it and was going through immunotherapy cancer treatment and was doing well. On 05Feb2021, she saw her in her office and was doing well with shrinkage and treatment with first mass, can decrease to once a month instead of 3 weeks. Then when she had second shot she just found out it got bigger. It was reported that on 07Apr2021, she got a CT scan and it showed she had another mass. She saw CT result sooner but did not discuss with her doctor until then. The CT scan also had emphysema (Start date: 2021) which she was not aware of as no one had ever verbally talked to her about that before. She saw the doctor on 14Apr2021 09:30, and said immunotherapy is no longer working. Her doctor wanted to stop the Keytruda, since it was not working, but they agreed to continue for 3 more sessions and do another scan after that. She has had things get worse, since she has a new mass and is having more issues with breathing since saying the immunotherapy is no longer working. One infusion of KEYTRUDA was skipped and then started again to see if it will kick in and start up again. The patient was wondering how the best way was to report a possible link and her immuno-therapy. Back when the vaccine first come out, it was questionable if cancer patients should or would get the vaccine and then they decided yes, and she did it. She would like to know if Pfizer was doing any further follow up with that population and was there any new info on cancer patients who have received the vaccine and whether are monitoring that. The patient underwent lab tests and procedures which included CT which showed she had another mass and emphysema on 07Apr2021. No other relevant test. Outcome for more issues with breathing was unknown and for rest of the events was not recovered. Information about lot/batch number has been requested.

Burning of mouth, lips, difficulty breathing. Lips swelled, cracked and peeled. Inside of mouth no longer burning , Swelling in lips has gone down, they have been peeling for days. Lips are red, still sore, but I'm hoping they are done peeling. I really don't feel I can handle another shot of this vaccine. I think I may have to cancel the second shot. I don't know what is it it, everyone keeps telling me it has no penicillin or sulfa drugs in it, but the symptoms are the same. The only difference is my hands haven't cracked and peeled along with my lips and mouth. I've had these problems since last tuesday night and am taking Benadryl trying to get some relief from it still. Please let me know if you have any solutions to prevent this.

10 hours after vaccine, very short of breath. Vaccine site very sore, red and bruised, entire upper arm. Paramedics called, not transported to hospital. Advised to not take 2nd dose. Benadryl given orally.

throat felt very tight; although I could swallow, it felt difficult to do so; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old female patient (non-pregnant) received first dose of BNT162B2 (Pfizer BioNTech Covid 19 MRNA VACCINE BIONTECH, Solution for injection) (Lot no: 5318) via unspecified route of administration at right arm on 29Jan2021 at 16:30 as single dose for COVID-19 Immunization. Medical history included high blood pressure and high cholesterol. Concomitant medications included Lisinopril, Amlodipine, Pravastatin, ergocalciferol (Vit. D). On 29Jan2021 after 15 minutes of receiving first dose the patient felt that her throat was very tight and although she can swallow, it was difficult to do so. This lasted between 10 to 15 minutes and gradually subsided and did not return afterward. Since the vaccination, the patient had not been tested positive for Covid-19. No other therapeutic measures were taken. Patient did not receive any other vaccine 4 weeks prior to COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Patient was not tested for COVID-19 since vaccination. The clinical outcome for the events throat felt very tight, difficult to swallow was recovered on 29Jan2021. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Patient's First Name added; Postal Code added; Patient's Ethnic Group captured. Patient's Age/Units captured as 80 years per event's onset=29Jan2021. For Relevant Med History: Verbatim "Blood pressure high" updated as "high blood pressure" per source reported. For suspect vaccine: Indication "COVID-19 immunization" captured twice, removed one. All Con-Meds were re-coded to remove from "Obtain Drug Country/Drug Authorization Country" since both fields should be Blank for con-med per SOP. 6. For all events: "Treatment Received?" captured as "No" per verbatim "if treatment ae: No"; Onset updated from "29Jan2021 00:00" to "29Jan2021 16:45" per source reported. Event term "difficult to swallow" updated as "although I could swallow, it felt difficult to do so" per source reported. "None" removed from Concomitant Therapy field since con-meds already coded in Product tab. Initial missed information "administration date=29Jan2021, administration time=04:30 PM", "adverse event start date: 29Jan2021, adverse event start time: 04:45 PM", "known allergies: No"

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

Felt weak; Dry throat; States she has noticed she has been burping a lot and coughing harder.; States she has noticed she has been burping a lot and coughing harder.; She has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up; she has been having shortness of breath that started when she got the first dose of the Pfizer COVID vaccine on 27Jan2021; Chills; she just felt tired was all; pain at the injection site in her right arm so she took Tylenol that morning; This is a spontaneous report from a contactable nurse (patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265) dose 1 via intramuscular route of administration in Arm Right on 27Jan2021 at 13:30(at the age of 80 years old) as single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. Patient had no other vaccines on the same day as the COVID vaccine. The patient experienced as, she has been having shortness of breath that started when she got the first dose of the pfizer covid vaccine, chills, she just felt tired was all, pain at the injection site in her right arm so she took tylenol that morning on 27Jan2021, felt weak on 07Feb2021, she has noticed she has been burping a lot and coughing harder, she has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up, and dry throat on an unspecified date on Feb2021. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. The patient underwent lab tests and procedures which included weight: 145-147 on an unspecified date. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. Outcome of the event shortness of breath and chills were recovered and unknown for rest events. Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.

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.

Dizzy; Nauseous; Unable to breath; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot unknown, via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunisation. Medical history included blood pressure increased. Concomitant medication included sertraline (UNKNOWN MANUFACTURER) for high blood pressure. On an unspecified date the patient experienced dizzy, nauseous and was unable to breath. The patient still had those symptoms and was wondering if it was normal and how much longer will these symptoms be. The outcome of the events was not resolved. Information about lot/batch number has been requested.

Patient started gasping and wheezing about 10 minutes post vaccine injection. She turned red and gasped for breath. She started crying and hyperventilating. I used an EpiPen on her immediately within 2 minutes of her turning red and she seemed to calm down for a few minutes. She was able to talk and ask questions. We gave her water to drink but then she started crying again and seemed to have more anxiety. Paramedics came within 15 minutes and took over.

12/28/2020: generalized weakness and fell twice at home, cough, nausea,1/04/2021: cough, nausea, fever and chronic pain when she fell from being weak. admitted to hospital with Covid pneumonia, shortness of breath, covid postive, 1/09/2021: pt on bipap, 1/15/2021: pt was intubated, on TPN, pt DNR, 1/18/2021: was extubated and put on comfort measures and passed away

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.

Got 1st covid vaccine 2/2/2021. Stayed at site for > 45 minutes. Was ok so she went home. Later that afternoon at 430 pm she was feeling short of breath. Not unusual for her, she has COPD. Nose plugged up. Thought the feeling would go away. Did not sleep well last night. Speaking in full sentences. Took her ventolin last night, did very little and then nebulizer last night. Did another nebulizer treatment this am. States breathing is "crappy". Went to ED on 2/3/2021

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.

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 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.

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.

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.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Seizure-Severe, Additional Details: The incident happened at COVID clinic. Patient was recieving the 2nd dose of the vaccine. The first time we administered the vaccine to the patient, she informed the immunizer that she had a bad cough for 3 days. The patient did mention that she suffers from seizures often. The 2nd dose was administerd by the RPH immunizer and was directed to the waiting area for 15 minutes. During that time in the waiting area, she was talking to the.

Patient received second dose of Pfizer vaccine. Both patient and her daughter went to the car to wait. Was approached by security as daughter returned to the center stating her mother was having a reaction. I went to the car & assessed patient. Patient c/o numbness/tingling along the left side of her face and head. Significant tremors and shortness of breath noted at the time. Daughter went and secured wheelchair & we brought the patient back into the vaccine clinic. VS at 1340: BP: 164/65, PO2: 88% on 3L, HR: 60 Patient reported anxiety prior to coming in for vaccine. VS at 1347: BP: 184/82, PO2: 94% on 3L, HR: 60. Patient states numbness/tingling increasing; reporting circumoral tingling/numbness. 25mg Benadryl given. VS at 1355: BP: 233/102, PO2: 92% on 3L, HR: 60 Discussed with Pharmacist. EMTs called for transport to ED per patient's request. Observed in ED and d/c home with no further treatment in stable condition.

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

Patient felt short of breath, lump in throat w/ difficulty swallowing, head ache & dizziness. Vitals 220/120, tachycardia, 98% on RA Treated w/ Benadryl 50, Pepcid 40 prednisone 60

About 10 min post vaccination, patient reported "tingling in the mouth and lips" and "tightness in the throat". Patients vitals were taken and within normal limits. Patient was then monitored one-on-one and reported slight difficulty breathing about 10 min later. Patient was given diphenhydramine 25mg PO x 1 dose. Patients vitals were taken again 10 min later and were within normal limits. Patient reported improvement of symptoms and was monitored for an additional 15 minutes.

She is experiencing an Allergic reaction, rash; little coughing spell; Itching eyes/My eyes started itching; Multiple hives all around her right eye; Wheezing; didn't feel comfortable; her upper lip became puffy/bottom lip began to swell; This is a spontaneous report from a contactable nurse (patient) via Medical Information Team. An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6201), intramuscular at upper left arm on 21Feb2021 at 08:30 at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccination within 4 weeks. The patient had no additional vaccines administered on same date of bnt162b2. Medical history included seasonal asthma, allergy to class A antihistamines that started in her 20s, facial & peripheral edema, blood pressure abnormal, and celiac disease. The patient had known allergy to Benadryl and when she takes it she gets peripheral and facial edema, lip swelling, top and bottom, hives around her whole right eye. The patient also has an allergy to Class A antihistamines that started in her 20s. She said the allergy started with Seldane & Claritin. She said she had giant hives with Claritin. She said she was told there were 2 classes of antihistamines & she couldn't use the Class A antihistamines. She said she previously reported her Seldane, Claritin & Benadryl allergies, saying she has facial & peripheral edema. She said she only uses the Class B antihistamine Cimetidine now. Concomitant medications included metoprolol, omeprazole, and pravastatin. On an unspecified date, the patient was experiencing an allergic reaction, rash. On 21Feb2021, the patient experienced "her upper lip became puffy/bottom lip began to swell," multiple hives all around her right eye, wheezing, and didn't feel comfortable. On 21Feb2021 at 14:00 (reported as about 2PM), the patient experienced "Itching eyes/My eyes started itching." On 21Feb2021 at 21:00 (reported as 9PM), the patient experienced little coughing spell. The reporter considered the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing as serious medically significant. The patient further reported that she felt fine after the shot, her arm was not sore, nothing. She said her arm was fine, and she had no problems, whatsoever, after receiving the COVID-19 Vaccine. She said she has had some weird allergic reactions in the past, but no anaphylaxis. About 12:00 to 12:30 PM (also reported as around midday), the patient's lip felt puffy. She said she had ate an apple and thought maybe something was on the skin of the apple. She said then her bottom lip began to swell, so she took 3 Cimetidine (NDC Number: 49035-820-72, lot number: 9AE2576A, expiry date: Dec2020). The patient stated that she was allergic to what she believe are class A antihistamines as they gave her facial and peripheral edema including Benadryl and everything on the list. About 2PM, the patient's eyes felt itchy, she took allergy eye drops (eye drops seasonal relief with tetrahydrozoline HCL 0.05% and zinc sulfate 0.25%. She said the product packaging reads it soothes eyes, and she said the eye drops worked. Lot number: AC8K275, expiration date: Sep2021). She said when she looked in the mirror, she saw a large hive on her eye (clarified as multiple hives all around her right eye). And about 4PM, she realized that her lips felt puffy, so she repeated the Cimetidine, it kept them from getting worse. At 7PM, her eye felt worse. She had this real hive that surrounded her right eye, she took a picture so she could report it to the doctor. The patient have an appointment on Wednesday. At 7:30PM, the patient's lips were puffy, she repeated the Cimetidine again and took of the 200 mg, she takes 3 at a time, she mentioned she could take 4, but she takes 3. She said she took more Cimetidine at 8:30PM, and talked to a pharmacist, who told her to call Pfizer to report her reaction. She said she attempted to call Pfizer last night, but it was too late, clarifying Pfizer Medical Information was already closed for the day. The patient also reported that she had a little coughing spell at about 9PM, so she stayed up with her husband till 10PM because she didn't feel comfortable. The patient told her husband to wake her up every once in a while. The patient felt a little wheezy, she used both of her inhalers, she could hear the wheezing, she used the serevent diskus (Serevent Diskus 50 mcg Inhaler. She said she has been using the Serevent Diskus Inhaler for seasonal allergies for years and the inhaler works. She said she occasionally uses the Serevent Diskus for colds during the winter. She said she realized she was wheezing last night and thought she should use the Serevent Diskus. NDC Number: 0173-0521-00, Lot Number: VV3E, Expiration Date: Sep2021) and Flovent (Flovent HFA 110mcg Inhaler, NDC Number: 0170719-20, Lot Number: C47A, Expiration Date: Jul2021). That seemed to be okay, she went to bed, and had a good night no problems. She said she woke up this morning and felt better. She said she sounds a little gunky this morning, clarifying that was somewhat typical for her. The patient further reported that she got up at 6:30AM, she took a shower, she was having a rebound reaction, and wheezing, so she took 3 more Cimetidine and repeated the inhalers. She clarified while her symptoms worsened after the hot shower this morning, her symptoms are much less than yesterday (21Feb2021), saying she was aware of her symptoms today, and paying attention to them. She said her lips became puffy, and she was wheezy after the hot shower. She said she took Cimetidine and her inhalers again this morning to treat the rebound reaction. She decided to repeat again at about quarter to 10AM, she repeated again trying to keep it under control. In the meantime, she spoke to her doctors office, and they just said keep doing what she's doing, and if she get real bad, call 911 or go to emergency room (ER). The patient have an appointment, the patient's big concern was that she probably shouldn't get the second COVID shot. She read on (website), that there was a very rare, mild anaphylactic reactions. What caught her eye was that this takes place about 4 hours after the dose. This was when her symptoms began, lucky her. Her whole life has been allergy related. The patient don't know if celiac disease has anything with this. The patient wanted to know whether or not there was some way to take the shot without killing herself. She said she was not having breathing difficulty, she was just wheezy. She said she repeated the Cimetidine about a half hour before she called Pfizer today. She said she called her doctor's office this morning, and her doctor said for her to keep treating her symptoms as she had been doing. She said her doctor told her to call an ambulance or go to the emergency room if her symptoms happen to get worse. She said she read online that skin anaphylaxis (hives, itching, and swelling of the eyes, face, lips and throat) can occur with the COVID-19 Vaccine. She clarified she read the information about the COVID-19 Vaccine at (Website name). She said she read skin anaphylaxis was extremely rare and less than 1% of the population has the allergy, and those individuals should not get the COVID-19 Vaccine. She said she was upset because what she read probably means she can't get the second COVID-19 Vaccine shot. She said she read the skin anaphylaxis appears within 4 hours after getting vaccinated with the COVID-19 Vaccine. She said her symptoms occurred in almost the same amount of time as to what she read about a skin anaphylaxis reaction to the COVID-19 Vaccine. She said she has a regular check-up on Wednesday (24Feb2021) with her doctor, and will speak further to her doctor about getting the second COVID-19 Vaccine. The reporter considered the events lip felt puffy, eyes started itching, hives, and wheezing as serious medically significant. The patient had no emergency visit. The patient had no relevant tests done. Therapeutic measures were taken as a result of the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing. The patient had not yet recovered from the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing while outcome of the events rash, little coughing spell, and didn't feel comfortable was unknown. The reporter considered the events swelling lips, itching eyes, hives, and wheezing as related to bnt162b2.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on 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.

Difficulty breathing about 8 hours after receiving the vaccine. Also felt panicky due to not being able to catch breath.

Pfizer-BioNTech COVID-19 vaccine treatment under Emergency Use Authorization(EUA): Female died 27 hours after receiving second dose of vaccine. Immediately after vaccine she had rapid breathing, almost hyperventilating. Medical history included Dementia and Parkinson's Disease.

Patient is an 81-year-old female with a past medical history of COPD on 3 L home oxygen, hypertension, tobacco use that presents to the ED for evaluation of shortness of breath. Patient states that she felt short of breath after receiving the Covid vaccine just prior to arrival to the ED. Patient states her symptoms are mild, constant, nonradiating, worse with exertion and no alleviating factors. She denies associated fever, chills, chest pain, nausea, vomiting, diarrhea. Patient states she is currently on prednisone therapy but does not know the dosage or duration. She denies history of heart failure.

No side effects in 30 minute waiting period and none on day of injection--some mild itching began night of injection. Day after, Saturday, itching intensified, throat tightened (muscular feeling); and tongue began to become sore, and began to show redness on sides. Bad enough that I finally took a 4-6 hour dose of Benadryl, and slept afternoon. Felt better when I woke up but when effects of Benadryl wore off, the tongue swelling intensified and frightened me. Decided against emergency call on weekend and took Benadryl (4-6 hour) about 8 or 9 Pm and next morning (about 5 or 6AM) noted that I felt okay and tongue had become pink not red though still some swelling on the sides of tongue. Had no strong adverse effects after first dose, some chills in the evening and arm swelling/pain that resolved by 3AM.

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.

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.

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.

ADR occurred in covid vaccination clinic 3/25/21. PT presented to ER for evaluation on 3/25/21 after receiving their 2nd dose of Pfizer covid vaccine received on 3/25/21. PT stated they developed mild lightheadedness and ?felt like their lungs were shutting down?. Patient felt short of breath briefly that started to resolve by the time they presented to ER but still felt short of breath. ER documentation stated on reassessment after labs, imaging and EKG, symptoms completely resolved. PT was discharged same day with instruction to return if any symptoms return. Pfizer Dose 1 LOT# EL9264, dose 2 LOT# EN6204.

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.

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.

Patient received her first dose of covid vaccine on 3/17 who comes to the hospital on 3/31 for increased fatigue and decreased appetite which began 3d after vaccine. In ER she tested + for covid and CXR was unremarkable, pt was discharged home. Patient returns to ER for increasing shortness of breath causing her to increase her home 02 to 3L and then ultimately 4L prior to EMS arriving. She notes she is dizzy and fatigued. She denies chest pain, n/v, but did have 1 episode of diarrhea PTA. This morning patient requiring 5L NC 02 and ID asked to evaluate for recommendations. Remdesivir withheld as symptom onsent > 2 weeks ago. Tocilizumab 8 mg/kg and dexamethasone 6 mg daily initiated.

81 years old woman with PMH of Anemia, CAD s/p CABG, Carotid stenions, CHF with EF 30%, COPD, DM, HLD, HTN, who presented to the ED with chief complaint of increase SOB over the last 5-6 days. The SOB got worse with exertion. Pt stated that she was using O2 only at the weekend but now she required O2 all the time. The associated symptoms wheezing, SOB, productive cough with yellow sputum, nausea, chills, fever, and diarrhea. Pt stated that she been having 6 episodes of diarrhea per days. Pt denied having any vomiting, chest pain, abd pain. Pt stated that she tested positive for Covid on 3/23/21. Per chart review, patient had 1st COVID 19 vaccine on 03/04/2021, tested positive for COVID 19 on 03/24/2021.

Patient received first and second dose of the Pfizer vaccine- first dose: 2/16 Lot#EL3302 in the right arm. Second dose on 03/09/21, Lot#EN6204 in the left arm. On 03/29/21- patient tested positive for COVID-19 and was hospitalized.

Died on 2/12/2021; diagnosed as a COVID-19 related death; 1st vaccine dose on 12/22/2020, 2nd vaccine dose on 1/14/2021. Hospitalized for acute respiratory failure with hypoxia and pneumonia due to COVID-19 infection.

Ongoing dizziness, lightheaded ness, shortness of breath. Visit to urgent care showed no remarkable results from blood tests and CT scan of head

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.

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.

weakness in arms and legs; shortness of breath; she felt terrible; achiness; energy level is just no energy; chills; could not walk across the room; This is a spontaneous report received from a contactable consumer (patient). An 81-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left shoulder upper arm from 13Mar2021 02:00 to 13Mar2021 02:30 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. No family history. No additional vaccines administered on same date. No Prior Vaccinations within 4 weeks. Patient received 1st dose of the Pfizer COVID vaccine on 13Mar2021 and experienced side effects on 31Mar2021. She mentioned that she could not walk across the room (2021) due to shortness of breath that began 31Mar2021 and was ongoing and about the same, her temperature was not high, down by 1 which would then be the onset of her chills (2021) which would come and go, just like a roller coaster, she felt terrible, had achiness, could not decide what to eat, and would feel better for 2-3 hours but felt bad right away. She mentioned that she felt just terrible and that all she wanted to do was die. Patient had whole body aching that was off and on since 31Mar2021 and not it finally diminished starting yesterday; she had weakness in her arms and legs that began not right away but on 04Apr2021 and was better; her energy level was just no energy and it started on 31Mar2021 and ran through 05Apr2021 and thank goodness the energy finally came back and she is finished now with that and feeling better since yesterday; she felt better but that only lasts 2-3 hours and she felt bad again and the chills start in again. She mentioned that she took acetaminophen and ibuprofen for the achiness, whenever needed. Patient stated she had no treatment, no visit to the HCP or emergency room and just took acetaminophen and ibuprofen and did not know when the took them but it was just in that timeframe. This morning, she had Gatorade to regain electrolytes and felt energized. As of calling, she was finally been feeling better and ally symptoms have decreased. AEs did not require a visit to ER or MD office. Outcome of shortness of breath was not recovered, outcome of achiness and weakness in arms and legs was recovering; outcome of other events was unknown. No investigation assessment. No follow-up attempts are needed. No further information expected.

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.

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.

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

Cough Pt states been sick for 1-2 wks, can't eat, no taste, fatigue, diarrhea, slight headaches, cough. Had 2nd covid shot 4/29/21. ? Diarrhea ? Fatigue Patient is a 81 y.o. female HPI Pt presents with concerns of possible Covid 19. Pt reports the following symptoms that started 10 days ago. Sinus pain and pressure No Fever/ chills Yes Headache Yes Body aches No Cough Yes Sob No Sore throat No Nausea/ vomiting/ diarrhea. Yes Loss of taste or smell Yes Medications used:Yes Tolerating fluids:Yes Tolerating. solids:Yes Smoke exposure:No Exposed to someone who tested positive for COVID 19: Yes History of asthma, bronchitis, pneumonia. yes Patient felt sick before receiving her second COVID 19 vaccine on 4/29. She states her and her husband were also exposed to someone at church who tested positive x 5 days ago and they were not wearing masks. She does use her rescue inhaler as needed for her cough. ED to Hosp-Admission Discharged 5/5/2021 - 5/17/2021 (12 days) Hospital MD Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Patient: Date: 5/17/2021 DOB: Admission Date: 5/5/2021 PCP: DO Length of Stay: 10 Days Discharging provider: MD Discharge Date: 5/17/2021 Admission Diagnosis Medical Problems 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 by LPN Note: Document: 08/22/19 - Consults Rheumatology - Paroxysmal atrial fibrillation Yes Atrial fibrillation with RVR Yes Esophageal stricture Yes

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.

she doesn't feel good; can't catch her breath; rib cage is kind of sore; Chills; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 23Feb2021 as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 23Feb2021 (last night), patient experienced chills. At 21:30, rib cage was kind of sore. On 24Feb2021 at 21:00, patient can't catch her breath. It was reported that chills stopped last night. Outcome: attempted to capture outcome of chills, unable to confirm if recovered completely or with last effects. The patient stated that they stopped last night, she does not have chills now but she does not feel good. Patient was calling to see what should she do. Should the patient go to a walk in. It was reported that patient handed phone to (name), because she said she had to catch her breath, to provide mailing address who also provided details intermittently during report. However, patient provided most of details during interaction. The patient was calling because she wanted us to advise her on what to do to get relief. She went online for urgent care and could not be seen until 11:00. She was hoping we would be able to get her in at Banner. She mentioned she waited almost an hour to wait to talk. The outcome of the event can't catch her breath was not recovered and outcome of the event chills was recovered and outcome of the others events was unknown. Information on the lot/batch number has been requested. Follow-up (14May2021): Follow-up attempts completed. No further information expected

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

Shortness of breath; dizziness; numb tongue; This is a spontaneous report from a contactable consumer (patient). This 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6199), dose 1 via an unspecified route of administration in Right arm on 05Mar2021 at 01:00PM (at the age of 81 years) as single dose for COVID-19 immunization. The patient's medical history included known allergies to the Opioids. Concomitant medications taken within two weeks included, Gabapentin 300 mg, paracetamol (TYLENOL 500), Acetylsalicylic Acid (ASPIRIN) 81mg, all were received for an unknown indication from an unspecified date and unknown if ongoing. The patient did not receive any vaccine within 4 weeks prior to the suspect vaccine. She did not have Covid prior vaccination. On 05Mar2021 at 01:15 PM patient experienced, Shortness of breath, dizziness and numb tongue. Patient received treatment for the events. She had not been tested for covid post vaccination. Outcome of all the events were recovered. No follow-up attempts are possible. No further information is expected.

Patient admitted to our hospital on 6/22/21 with shortness of breath and acute hypoxic respiratory failure in the setting of COVID-19 infection. Patient is fully vaccinated. Patient resides in a nursing home. Her COVID-19 did test positive for a variant by IDPH testing but IDPH would not disclose the identity of the variant when contacted. Patient was treated with oxygen, remdesivir, and dexamethasone. Patient improved and was discharged back to her nursing home on 6/27/21.

Shortness of breath/breathing problems; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 27Feb2021 (at the age of 81-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included heart and blood pressure, depression and asthma. Concomitant medication included metoprolol taken for heart and blood pressure from Jan2021 and ongoing, escitalopram taken for depression, start and stop date were not reported and medication for asthma.(allergy drug for asthma). Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EM9810), via an unspecified route of administration on 06Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. On 04Mar2021 the patient began to experience shortness of breath/breathing problems. On 06Mar2021 she was seen in the emergency department and evaluated for her shortness of breath. On an unknown date in Mar2021 she underwent computerised tomogram (CT) of her lungs which resulted normal (found nothing wrong). She received montelukast 10mg as treatment for the event. Stated that she began experiencing shortness of breath on 04Mar2021, she thought it was just normal so she did not do anything, states it continued and on Saturday morning, 06Mar2021 she went to the emergency room. On an unknown date in Mar2021 they did all the tests, CT of her lungs and everything and they found nothing wrong. She followed up with her family doctor who told her it was not an allergic reaction to the vaccine because if she was going to have one it would have been closer to when she got the vaccine. States she was then started on an antidepressant and an allergy drug for asthma. Clarifies she began escitalopram 5mg, and a medication for asthma, Montelukast, 10mg at night time for breathing to take at night, clarified this was all back in Mar2021. Caller stated she had been on medication since then, and it helped some. She wanted to know have other people had this problem from taking the vaccine, have they reported shortness of breath after the vaccine. She stated tomorrow she was going to the cardiologist. At the time of report, outcome of the event was not resolved.

Well I have got congestion in my lungs and I got it I don't remember when. I had to have gotten it prior to going to the Dr. So I was sleeping and woke up at about 12:15AM in the middle of the night and I was coughing and coughing and could not catch my breath. I raised my hands above my head and that helped. Then after that was when the congestion and constant coughing began. The coughing and congestion I had but I felt like I had the flu so I didn't think anything of it. I went and got bloodwork on the 22nd of June 2021. I got bloodwork again in June on the 29th as well. My first visit to my Dr. was 3/29/2021 actually, and then again June 29th. The Dr. prescribed atorvastatin and lisinopril 5mg, and also Claritin 10mg.

Blood clots in Lungs discovered June 29, 2021 after being admitted to hospital June 28th. In the weeks leading up to diagnoses patient was feeling extreme lethargy, nauseous, lack of appetite and general extreme discomfort.

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.

she felt her scalp itch like there were bugs on it/Scalp was just itching like crazy; headache; muscle and joint pains; muscle and joint pains; chills; temperature was 99.8 so the next time I took it and it was 100.8; felt lethargic; didn't get sleep that much; my throat closing up; This is a spontaneous report from a contactable consumer, the patient herself. An 81-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8732; Expiration Date: 31Jul2021), via an unspecified route of administration, on 26Mar2021 (age at vaccination: 81-year-old), as single dose for COVID-19 immunization. Medical history was reported as none (not heard anything from anybody). There were no concomitant medications; she did not take any medications because she did not know if it was permissible. The patient previously received first dose of bnt162b2 (Lot Number: EN6198 and Expiry: 30Jun2021) on 25Feb2021 and she did not experience side effects from that dose. The patient reported that, yesterday (26Mar2021) was fine, it did not hurt the arm and everything, however, at 2 o'clock this morning, on 27Mar2021, she felt her scalp itch like there were bugs on it. Her scalp was just itching like crazy, and it would not stop itching so she just had to run her fingers through there, got a little bit of alcohol and just kind of rubbed it in there but it was just something under the skin. She then experienced headache, muscle and joint pains, chills, and a fever. She took her temperature, and it was 99.8 so the next time she took it, and it was 100.8, but since then it had got down to 99.7, so she still felt like she had fever. She had a feeling that she was slow and just did not want to do anything and that was how she left the day because she did not know whether she was going to react to it or not but there was no swelling around the injection site, no nausea, did not have swollen lymph gland, heart beat was not fast, did not have a bad rash, dizziness (not clarified further if had dizziness or not), no weakness, maybe weakness from no sleep because she hardly had any sleep and also felt lethargic. She did not see any swelling of face or throat, so she was mainly worried about her throat, maybe her throat closing up. She mentioned that these not concerned her and as long as she could swallow, she did not panic and could bear it. She said that she had been through so many shots in her life and she never had a reaction like that before so she did not think she would be required to go to the emergency room or anything like that because she just did not feel, but she said yes that was important that she take care of this, but it was not emergency in her book. She was so hungry, she just had a muffin and was not vomiting yet, she did not think anything would happen like that, as she did not think it was serious. Reportedly, she did not throw up and she felt like it would be more bearable for her to have food in her belly. She told that, she purposely did not have any lab test done because she knew this COVID was coming up and she had to have 3 boosters that she needed to take, but she was going to take them 2 weeks after. She also reported that, she did not take corrective treatment for fever and itchy scalp, as someone told her not to take anything, Tylenol or an Aspirin, so she did not. The outcome for the events: fever and itchy scalp was recovering (It was improved throughout the day and she walked around the house a lot just, because she exercises), and the outcome was unknown for the rest of the events. No follow-up attempts are possible. No further information is expected.

Patient started experiencing shortness of breath and fever about 3 days PTA (admitted on 7/17/21) and was treated with a Zpak and doxycycline as an outpatient. Her symptoms did not improve, so she presented to the ED on 7/17. Patient was tested for COVID per protocol and the test came back positive. CT PE came back negative, but a large left pleural effusion was discovered and patient was admitted for treatment. Since pt remained on room air during her hospitalization, Infectious Diseases decided not to treat pt for COVID since pt is fully vaccinated (received Pfizer on 2/8 and 3/11) and they didn't believe her presentation was caused by COVID. Pt had a similar presentation of LLL PNA with pleural effusion in 12/2019.

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

Pt started feeling short of breath about 20 minutes after vaccine was administered. Husband honked horn from parking lot as instructed if any adverse reactions. Initial assessment: pt SOB, flushed, able to communicate, calm. 911 called and paramedics on scence in 1 minutes (we were at Firehouse for vaccine clinic). BP 179/68, HR 88, RR 28, Ox 99%. After monitoring, paramedics cleared patient to go home. Patient started feeling better after a few minutes of paramedics arriving. Encouraged by them to take Benadryl/Tylenol for any effects and to call 911 if she started to feel SOB again or had any other concerning symptoms. Husband and pt both verbalized understanding.

her arm felt like it was on fire, body feels flushed, and felt like her throat was going to close up but it didn't; her arm felt like it was on fire, body feels flushed, and felt like her throat was going to close up but it didn't; her arm felt like it was on fire, body feels flushed, and felt like her throat was going to close up but it didn't; Injection site felt like it was on fire; Felt fine today and was fine 2-3 hours after the onset of the hot and fiery feeling; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E73246, expiry date not reported), via an unspecified route of administration on 06Jan2021 14:15 in the left arm at single dose for COVID-19 immunisation. Medical history included cardiac pacemaker insertion, high blood pressure for years. Concomitant medication included apixaban (ELIQUIS). The patient previously took flu shot (FLU VACCINE II) and never had a reaction to the flu shot, macrodantin and experienced drug hypersensitivity and hives. It was reported that about 15:15, injection site felt like it was on fire and then the whole arm felt like it was on fire. The patient got concerned. Her throat felt like it was going to close. Symptoms got less severe. She was fine yesterday and was fine that day. She called her doctor and was advised to put cold compresses on the arm and take Tylenol. She was ok. She read an article that stated if a person had a reaction to not have the second shot. She did not know if her reaction is severe. The second shot is due around 27Jan2021. She wanted to know what to do. She felt fine on the day of report and was fine 2-3 hours after the onset of the hot and fiery feeling. It was scary and she didn't know what was happening. She also added that around 15:15, the injection arm felt like it was on fire. She felt flushed. Her throat felt like it would close up but never did. Everything resolved 2-3 hours after it started. Clinical outcome of the events was recovered on 06Jan2021.

C/O feeling weak and felt like her throat was closing almost immediately after receiving vaccine. Patient was evaluated by ED. No evidence of anaphylaxis. Treated and released without.

Slight ache at injection site....lasted about 2 days Woke up Friday am...approx. 15 hrs. after injection...with large swollen area in throat under right side of chin...presumably a lymph gland, which is sore to the touch and uncomfortable when swallowing. Has not gone away yet. Seeing my Doctor tomorrow.

12 hours post vaccination - couldn't lift feet off floor, had to shuffle her feet to walk, headache, brain fog, memory difficulties, body ache, sinus drainage, extreme tiredness, tenderness at injection site, increased shortness over breath 24 hours post vaccine- mild headache, tiredness, joint pain, lethargy, no pain at injection sight, able to walk fine, mild shortness of breath,

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

The individual received the vaccine around 12:00pm on 02/11/21. Around 9pm the individual went to lay down on the couch at home and started to have difficulty breathing. Within 30 minutes the individual became week and unresponsive. She was transported to the hospital where she was pronounced deceased at 11:44 pm on 02/11/21.

Pfizer-BioNTech COVID-19 Vaccine EUA The first symptoms to appear at approximately 8:00 pm on Feb. 9th the day of my mom?s vaccine were headache and diarrhea. The following day, 2/10 she seemed to feel better and went on with her day. The night of 2/10 she awoke coughing and wheezing. She called 911 at approximately 4:45 am on 2/11. They transported her to hospital.

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.

Patient received first dose of vaccine. Experienced light headedness, feeling stuffy, and trouble breathing. Patient was transported to emergency room for evaluation. Patient was observed but did not require treatment or intervention.

throat tightening; discomfort; little swelling; This is a spontaneous report from a contactable consumer. An 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 26Jan2021 10:15 at single dose on Left arm for covid-19 immunisation. Medical history included has a lot of allergies, reactions to honey and penicillin, She experienced neck swelling after receiving penicillin. Caller took the 1st dose last 26Jan2021. she and her husband got the Covid-19 vaccine yesterday. While reporting on her husband, caller states she had a reaction to the vaccine. After receiving the shot, Caller was put on the side for half hour and 15 min later, she experienced her throat tightening on 26Jan2021. Caller was given Benadryl and observed for 10 min. Her husband received his shot but "he did not feel the needle going into his arm. Weight is between 120-123lbs. Caller mentioned that she has a lot of allergies. They watched her for 30 minutes after getting the vaccine. Within 15 minutes her throat was feeling a little tight. It cleared after about 10 minutes. Her vital signs were checked and were fine. Thy also gave her some Benadryl. She takes vitamins and minerals because she believes in them. Outcome of the event throat tightening recovered on 26Jan2021 and events was unknown.

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

Immediately after receiving the vaccine, client started c/o severe pain in her arm and lightheadenness and shallow breathing. vital signs monitored. no meds administered. Son at her side. This information was obtained from her son. He says she has bad arthritis and the shot hurt her and she almost passed out. She has had no other problems since and didn't have any with the first dose.

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.

Pain on the lymph nodes/lymph nodes hurting; Hurting really bad; Pleurisy before getting the vaccine/after getting the vaccine it got really bad; Pleurisy before getting the vaccine/after getting the vaccine it got really bad; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261; Expiration date: 31May2021) on 21Jan2021 (07:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the clinic (not a military facility). Medical history included being a diabetic from 2005 and ongoing (was not on insulin, only on pills); ongoing chronic obstructive pulmonary disease (COPD) in her 50's (also reported as "it has been a while"), and was not on oxygen; ongoing anxiety attack; had a problem with her left lymph nodes in her breast; and had pleurisy that was not really that bad (taking paracetamol (TYLENOL)). Concomitant medication included ongoing metformin for being diabetic. In Jan2021, the patient had developed pain on the lymph nodes after receiving the vaccination; and the patient was hurting really bad. The patient was previously diagnosed with pleurisy (prior to the vaccination), and it was described as "bad enough for her to take Tylenol" and it was just distracting before. After getting the vaccination, in Jan2021, the patient's pleurisy got really bad, and stated that the vaccine might have attacked her lymph nodes especially the lymph nodes on her left breast, left chest, under arm and back, and that she thought the vaccine had made the pleurisy worse. The patient's condition was so bad that she had to go back to the doctor; events resulted into physician office visit. The patient was informed to take two ibuprofen 200 mg a day as treatment for the reported events. The patient had a chest-ray in Jan2021 after the doctor had diagnosed her with pleurisy (results were not provided). The outcome of the events was not recovered for 'pleurisy that got really bad'; and was unknown for 'pain on the lymph nodes' and 'hurting really bad'.

Vaccine recd 1/20 and 9 days after I got really sick and still having breathing trouble and short of breath, now using breathing treatments, I'm having a hard time walking, weakness all over, headaches, and I feel so out of it.

Family call Clinical Lead to car for elderly woman in backseat of car who had become unresponsive. Patient lying on side. Wearing portable NC o2. Unresponsive to verbal/sternal rub. No pulse, No resps. Called AMR to car side who called 911. Transferred patient to a gurney and began CPR as we transferred to AMR rig. EKG - showed PEA - CPR continued - patient intubated by AMR - epi is given. Pt transported by AMR/Fire to hospital. Pt was a full code on Hospice - she passed away 3/11/21 with the following cause of death: 1.Acute-on-chronic hypoxemic/hypercarbic respiratory failure, multifactorial in origin. 2. Possible aspiration pneumonia, present on admission. 3. Bronchiectasis, chronic, secondary to asbestosis. 4. Acute combined metabolic and toxic encephalopathy, present on admission. 5. Out of hospital pulseless electrical activity arrest. 6. Hyperkalemia. 7. Cardiogenic shock. 8. Acute kidney injury. 9. Lactic acidosis. 10. Acute diastolic congestive heart failure. 11. Severe protein-calorie malnutrition.

dizziness; hallucinations; disorientation; fever/she had fever again; pain in the arm/pain in left arm; loose appetite/without appetite; forgetting things and words; could not even put up a sentence; difficulty breathing; needed help to walk; needed help to get dressed and eat due to hands tremor issue; vomiting; pneumonia; stopped eating; she was always tired; sleepy; stiffness in extremities; oxygen was low; she was not responsive/following instructions; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Feb2021 08:45 on Left arm at single dose for COVID-19 immunization. Medical history included Hypertension. Concomitant medications included acetylsalicylic acid (ASPIRIN PROTEC), atorvastatin, losartan. The day of the vaccine administration she had fever and pain in the arm on 14Feb2021 20:00, next day on 15Feb2021 started with dizziness, hallucinations, disorientation. As the days went on in 2021, she started to loose appetite, forgetting things and words, she could not even put up a sentence but most importantly she had difficulty breathing, needed help to walk, get dressed and eat due to hands tremor issue. Afterwards; she had fever, vomiting, pneumonia and stopped eating, she is always tired, sleepy, with stiffness in extremities and pain in left arm. She was 1 day hospitalized and we had to bring her back to hospital because her oxygen was low, she had fever again, without appetite and she was not responsive/following instructions. All events were resulted in Emergency Room Visit and Physician Office Visit, Hospitalization for 1 day. Treatment received for the events included Oxygen, fluids, antibiotics. Lab data also included covid test type post vaccination=Nasal Swab on 01Mar2021 with Negative result. The outcome of the events were not resolved. Information on the lot/batch number has been requested.

Pt received the covid vaccine on 2/4/21 and 2/26/21. On 3/19/21, she presented to the Care clinic with shortness of breath. She tested positive for COVID and was referred to the ED for further care

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: pt was very anxious -Severe, Systemic: Shakiness-Severe, Additional Details: after pt received her shot she shopped in the store and then sat down and was very anxious, dizzy, and was shaking uncontrollably

Heart attack; Asthma attacks; This is a spontaneous report from a contactable consumer (the patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Left Arm on 16Mar2021 10:00 (Batch/Lot Number: EN6206; Expiration Date: 30Jun2021) as single dose for COVID-19 immunization. Medical history included asthma from an unknown date (she has had Asthma for about 14-15 years), broke back from an unknown date (she broke her back about 3 years ago); stent placement from an unknown date (she had 2 heart stents placed about 2 years ago), and then she said she was allergic to a couple of fairly common medicines (statins and NSAIDs) from an unknown date. There were no concomitant medications. The patient received her first Pfizer COVID-19 Vaccine on 16Mar2021. She said she would really like to know if the COVID-19 Vaccine possibly caused her to have the worse asthma attack she ever had in her life on 17Mar2021. She clarified she was talking to her friend on the telephone when she had her asthma attack at 3:30PM. She said that on 18Mar2021 at 5:00AM, she had a second asthma attack. She said her second asthma attack was not as bad as the one she had on 17Mar2021. For her first asthma attack on 17Mar2021, she took 2 puffs from her inhaler, and then an additional 2 puffs (4 puffs total). She said her doctor told her if she had a bad asthma attack, she could take 2 more puffs from the inhaler. She said she normally takes 2 puffs from her inhaler. She said for her second asthma attack on 18Mar2021 she took only 2 puffs from her inhaler. After she took her 2 puffs from her ProAir HFA Albuterol Sulfate inhaler, she flopped back into her bed. She reported she normally has 3-4 asthma attacks a year. She reported that her doctor did a complete blood workup on 03Mar2021 and told her she was doing just lovely. The patient also reported she had a very mild heart attack and she can't even take low dose aspirin. The patient also reported she had another question about the COVID-19 Vaccine. She said she was allergic to a couple of fairly common medicines (statins and NSAIDs) and wanted to know if anything in the list of the COVID-19 Vaccine ingredients would indicate her having a possible allergy to the vaccine. The events did not require a visit to Emergency Room and/or Physician Office. The outcome of the event asthma attack was recovering, and for the heart attack was unknown.

She developed widespread hives that have lasted for two weeks, prolonged debilitating fatigue and weakness that have left her unable to participate in her life. 15 days later she is still struggling with shortness of breath and extreme fatigue and hives.

Patient is an 82-year-old female who came to the emergency department today complaining of shortness of breath. Patient also reports that she has cough, low oxygen and recently received her second Covid shot and when EMS picked her up she was 83% oxygen saturation on room air. Patient has what sounds like pooling secretions in her throat and patient had suctioning done by respiratory which caused her to bleed blood noted in teeth and around mouth. Patient reports that her throat has been hurting her and that is why she has been unable to eat. Patient's daughter is at bedside and is historian for majority of the assessment. Patient's daughter reports she has not been eating or drinking for the last 2 days. Labs in ER showed WBC 11.61, lactate level 3.3, creatinine 2.0, procalcitonin 5.33, magnesium 1.5, BNP 2100, glucose 474. Chest x-ray showed no acute findings.

4/10/21 ER HPI: 82 y.o. female who presents to the Emergency Department by paramedics from a local nursing home. The patient is an 82-year-old female with a known history of end-stage renal disease, diabetes, and coronary artery disease. She presented to the emergency room after being transported from a local nursing home. Apparently, the patient was acting a little bit more confused than normal and she was looking more short of breath than normal. The nursing home nurse stated that her oxygen saturations were in the upper 80s without oxygen and the patient looked visibly more short of breath than normal. Because of this, the nursing home made the decision to send the patient in. When paramedics arrived at the nursing home they placed 2 L of oxygen on her and her oxygen saturations went up into the high 90s. The patient does dialysis on Monday, Wednesday, Friday. She did not miss a dialysis treatment this week. The patient has had her coronavirus (COVID-19) vaccine and several months ago did have coronavirus (COVID-19) at the local nursing home. The patient does have mild dementia and so is somewhat of an unreliable historian. Transferred to pleural effusion

4/9/21 before 8am - coughed up large amounts of blood, went to ER at hospital several hours later. Admitted to the hospital for 4 days after finding blood clots in the lungs.

Patients husband was bringing his daughter to a vaccine event. Spouse spoke of concern over his wife having a Pfizer COVID-19 vaccine in January and withing 24 hours being found unresponsive. Patient details that she did not show symptoms of distress after this second vaccination. He went to check on her in the morning on 1/28/21 at different points in the morning but when checking on patient at around 11:00 AM she was found laying on her side unresponsive, not breathing. Emergency medical profesisonals arrived but resuscitation efforts were unsuccessful.

Shortness of breath was reported as worsened/Sweating was reported as worsened; shortness of breath; sweating; Tiredness; pulse starts beating very fast at night; This is a spontaneous report from a contactable consumer (patient, self-reported). This 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL8982 and expiry date: on an unknown date in Jun2021), via an unspecified route of administration, in left arm, on 27Jan2021, as a single dose for COVID-19 immunization. Patient's medical history included plugged vessels/veins and high cholesterol. Concomitant medications were not included. On 03Feb2021, the patient experienced shortness of breath, sweating and tiredness. On an unknown date in Feb2021, the patient's pulse starts beating very fast at night. On 09Feb2021, the experienced shortness of breath was reported as worsened, and sweating was reported as worsened. Also, the patient was sweating at night, but even today at work, she was even sweating during the day. On 17Feb2021, the patient was scheduled for the second shot. Outcome of the event dyspnea and hyperhidrosis were not recovered. Outcome of the event fatigue was recovering. Other events heart rate increased and condition aggravated were unknown.

Approximately 40 hours after second Pfizer vaccine, patient complained of pain in lower right leg, and a cold foot, lethargy, weakness, feeling unwell. 3 days later, shortness of breath, difficulty breathing, rapid heartbeat, and confusion began. Went to Medical center on 4/20/21, diagnosed with DVT, PE and clots in and around the heart and passed away on 4/21/21 of cardiac shock in the setting of pulmonary and arterial thrombosis.

82 year old female presenting with fever, cough and wheezing for 2 days. Symptoms unchanged. No sick contacts or exposures. Taking tylenol with symptom relief. Hx HTN and COPD. Non smoker. Not using rescue inhaler. Had flu shot. Had 2nd covid vaccine on 3/6/2021/ No prior covid infection. COVID positive

states immediately after getting vaccine had pressure in head that lasted all day. later had chills and an asthma attack

Patient started to experience left arm pain hours after the vaccination on 05/04/2021, and the pain gradually moved to the patient's left chest wall, anterior chest and right chest wall, patient was having shallow breathing limited by pleuritic pain, presented to the ED on 5/10/2021 and was diagnosed with acute bilateral nonobstructive pulmonary emboli based on CT angiogram chest.

leg swelling; ultrasound showed an occlusive clot in her femoral artery; femoral vein clot; had pneumonia; fever; developed chills; then chest pain; shortness of breath; This is a spontaneous report from a contactable physician. An 82-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER CORONA VIRUS VACCINES-COVID-19), dose 2 intramuscularly administered in the right arm on 04Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. Medical history included hypertension, hypothyroidism and osteoporosis. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the first dose of bnt162b2 (BNT162B2 reported as PFIZER CORONA VIRUS VACCINES-COVID-19) on an unspecified date for Covid-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID); calcium; acetylcysteine, calcium levomefolate, mecobalamin (METAFOLBIC PLUS); losartan; hydrochlorothiazide; denosumab (PROLIA) and trazodone; all indication, start and stop date were not reported. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that in the evening of the vaccination (04Mar2021), she developed chills and fever, then chest pain and shortness of breath. The physician obtained a CXR (chest x-ray) on the patient on 04Mar2021 and found that she had pneumonia. She was treated with levofloxacin and prednisone. The physician rechecked her in one week and gave her Kenalog injection and Rocephin injection. The physician rechecked her on 22Mar2021 and she was improved, but she returned to the office 12Apr2021 with left leg swelling. The ultrasound on 12Apr2021 showed an occlusive clot in her femoral artery. The patient was admitted to the hospital (Apr2021) for 1 day and placed on heparin, then sent home on Eliquis. The adverse events resulted in doctor or other healthcare professional office/clinic visit and the patient received treatment which included antibiotics and steroids for pneumonia and blood thinners for the femoral vein clot. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events leg swelling, occlusive clot in her femoral artery and femoral vein clot were recovered on Apr2021 while the outcome of the other events was recovered on 22Mar2021. Information about lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events peripheral swelling, peripheral artery thrombosis and venous thrombosis limb and the suspect drug BNT162B2 cannot be excluded.The case will be reassessed once new information is 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 Committees, and Investigators, as appropriate.

Encounter Details Date Type Department Care Team Description 04/22/2021 - 04/29/2021 Hospital Encounter Acute respiratory failure with hypoxia (Primary Dx); Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present; Pneumonia due to COVID-19 virus; Pneumonia due to 2019-nCoV; Simple chronic bronchitis Details of the Hospital Course: Patient is a 82 y.o. female with COPD follows with the respiratory disease specialist outpatient, history of mediastinal mass s/p VATS procedure done by Dr. in June 2011, pathology came back benign thymoma, she subsequently developed a slowly growing posterior mediastinal recurrence that was resected by Dr. in June 2016 and was felt to represent "recurrent/metastatic thymoma?type AB", with surgical margins < 1 mm; she declined postoperative XRT, last seen by Dr. in April 2020 recommended repeat CT in 1 year for evaluation who presented to the ER on 04/22/2021 with complaints of shortness of breath, found to be hypoxic on room air with pulse ox of 87% and found to be positive for covid 19 (of note: patient received her first COVID 19 vaccination mid April). Chest xray showed radiographic evidence of pneumonia in RLL but without evidence of acute PE on CT scan. Patient was requiring 15 L of supplemental oxygen to maintain oxygen saturations and so was placed on high flow nc with better response 4/23 remained on HFNC 4/24 BCx from 4.22.21 growing out gram positive cocci in 1/2 bottles 4/26 HFNC at 50% and 45L 4/27 off HFNC and on 6 L NC/ awaiting PT evaluation 4/28 per, OT assessment -- pt dropped into 70's on 6L 02 with short walk to bathroom and toileting tasks. cues for rest and PLB needed to increase 02 into 80s. with a seated rest break over 5 mins 02 increased to 88% on 6L COVID pneumonia (first dose of Pfizer vaccine mid April) S/P remdesivir X 5 days, now on day 8/10 decadron but will go home on oral decadron Acute hypoxic respiratory failure slowly improving (not on home oxygen therapy) now off HFNC, was on 10 L oxymask. Patient's pulse ox this morning at rest on 4 L was 86% but improved to 92% on 5 L NC -will need 5L home oxygen therapy at discharge (new) -discussed the need to follow up with Dr or PCP to wean off supplemental oxygen. Patient agreeable with this plan Transaminitis levels trending downwards. History of thymoma s/p VATS 2011 -outpatient follow up Positive blood culture on admission, contaminant in 1 of 2 blood culture bottles. Repeat blood cultures showed no growth. Not on antibiotics Associated attestation - 04/22/2021 3:39 PM EDT Formatting of this note might be different from the original. Patient seen and examined. Current status reviewed with resident staff. I have reviewed pertinent physician documentation, laboratory and radiographic data. I have initiated therapies based upon this reviewed In brief 82-year-old woman with history of COPD, mediastinal mass status post VATS with benign thymoma with local recurrence presented with respiratory tract symptoms since 6 days prior to admission COVID testing is positive. In the emergency room she was noted be hypoxemic requiring 15 L of supplemental oxygen to maintain oxygen saturations. She is currently on high-flow feels much improved. I concur with exam as per Pulmonary fellow. Laboratories and imaging reviewed in detail. Impression COVID-19 infection COVID-19 pneumonia Severe hypoxemic respiratory failure requiring high-flow oxygen Thrombocytopenia which is new since 2016 and a poor prognostic sign History of benign thymoma with local recurrence COPD with exacerbation Doubt bacterial pneumonia Recommendation: Remdesavir 5 days Corticosteroids. Optimum dosing induration of corticosteroids has yet to be fully defined. Decadron 6 mg daily is reasonable however if develops progressive disease in the next 24 hr would escalate corticosteroids and would also add IL 6 inhibitor Additional minerals and vitamin supple role is unclear but probably benign If thrombocytopenia worsens may need alternative anticoagulation. Would check venous Dopplers Supplemental oxygen for saturations greater than 88% Daily PPI unless anticoagulation intensified then would go to q.12 hours Would favor discontinuing antibiotics

Shortness of breath.; pain in left shoulder/arm/breast; pain in left shoulder/arm/breast; pain in left shoulder/arm/breast; This is a spontaneous report from a contactable consumer (patient). This 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 14:30 (Lot Number: EN6200) as single dose (at 82 years old) for COVID-19 immunisation. Medical history included complex regional pain syndrome, scoliosis, primary biliary cholangitis, hypersensitivity. On 26Feb2021 00:30, the patient experienced shortness of breath, pain in left shoulder/arm/breast with outcome of not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

Chills, Fever, sore throat, running nose, constipation, Diarrhea, shortness of breath, muscle cramps in both legs, muscle aches in all parts of body. Each symptom was not severe except muscle cramps. Muscle aches and shortness of breath still happening.

Hospitalization due to shortness of breath, diagnosed with bilateral pulmonary embolism. The PUI lives in a Senior Living facility and she was taken to the hospital for blood clots in her lungs. They did a Covid test and she was positive, but she had not had any symptoms and was vaccinated in February. The later had another Covid test done at the hospital, where where she was for 3 days and the test came back negative.

After the shot I was fine for 4 days and then I started having a hard time breathing; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in right arm on 11Mar2021,at 03:15 as single dose for covid-19 immunization, at the age of 82 years. The patient's medical history was 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. No allergies to medications, food, or other products were noted. No other vaccines were administered within 4 weeks and no other medications were given two weeks prior to the COVID vaccine. The patient was not pregnant. The patient noted "after the shot I was fine for 4 days and then I started having a hard time breathing" on 15Mar2021, at 14:00. The clinical outcome of the event was unknown. No follow-up attempts are possible; information about lot number cannot be obtained.

Patient is a 82 y.o. female with history of adenocardinoma left lower lobe lung s/p radiation, COPD, nocturnal use of 3 liters oxygen, dementia, eliquis for hx dvt, esophageal stricture who presents today from clinic secondary to hypoxia. History obtained from daughter bedside and chart review as patient has dementia. Patient began feeling ill one week ago. Complains of cough, congestion, wheezing, shortness of breath, mild wheezing, chest discomfort with coughing, fatigue, and decreased energy. She has had one episode of loose stool. Denies fevers, chills, loss of taste/smell. She was evaluated by pulmonology on 5/25 and noted to have oxygen desaturation. She was recommended to go to the ED for further evaluation however patient refused and preferred home treatment. She was prescribed Augmentin for possible aspiration pneumonia as well as prednisone taper. Patient reportedly felt some mild improvement since starting treatment however continued to require use of 3 liters of oxygen during day and night rather than just at night. She followed up with clinic today where she continued to have oxygen desaturation despite supplemental oxygen and chest xray noted new infiltrate. She was again recommended to go to the ED for further evaluation and management at which time patient agreed.

within 24 hours after second dose of vaccine my mother complained of chest pains and shortness of breath. She saw her Primary Care Dr on 5/10/2021 after experiencing dizziness, fatigue, confusion. She had lost a considerable amount of weight during this time and I was concerned and accompanied her to the doctor visit. Dr prescribed cyanocobalamin B-12 as she had been defficient in her latest blood analysis on 3/15/2021. She also added Donepezil 5mg tablet daily and trazodone 50 mg nightly to help with sleep. She gave referral to get Neuroligical evaluation. My mother had a driving episode on 4/30/2021 where she was taken to Medical Center and some Scans were taken of her brain that were apparently normal they contacted me to pick her up around 2:30 AM 5/01/2021. The number on her release folder to obtain medical Records. My mother was residing with me my home until her appointment for evaluation . She passed away on 6/02/2021 in my home.. Dr was contacted to sign off on her Death Certificate . I have not received Death Certificate as of today but I believe the cause she was putting was Natural Causes due to age.

Patient came to emergency department with complaints of midsternal chest pain radiating to the back that started on 6/13/21. Patient discussed pain as severe sharp chest pain that worsens with taking a deep breathe, movement, and coughing, Patient was diagnosed with pericarditis. Patient was admitted to the hospital for observation, monitoring, and evaluation. Patient was given Toradol 15mg IV and monitor chest pain.

Chills; fever; severe fatigue; headache; nausea; joint pain; trouble breathing; One week very sick; Was bed ridden since 01Mar2021; This is a spontaneous report from a contactable consumer (Patient). A 83-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: E L3302) via an unspecified route of administration in left arm on 01Mar2021 at 00:00 (age at vaccination 83-year-old) at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, heart disease, cancer survivor, fibromyalgia and high blood pressure. Patient had known allergies. The patients concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. 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 01Mar2021, at 00:00 patient experienced chills, fever, severe fatigue, headache, nausea, joint pain and trouble breathing. Patient was bedridden since 01Mar2021 the day of the shot and was very sick for one week. Therapeutic measures were taken as a result of chills, fever, severe fatigue, headache, nausea, joint pain, trouble breathing, one week very sick, was bed ridden since 01Mar2021. The outcome of event was recovering at the time of reporting. No follow-up attempts are possible. No further information is expected.

She just feels terrible; Trouble walking; Splitting headache; Shortness of breath; Cough; She can't do her daily activities/she feels out of sorts; This is a spontaneous report from a contactable consumer. This 82-year-old female consumer (patient) reported. A 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH, COVID-19 vaccine, solution for injection; Batch/Lot number: EN5318), via intramuscular, administered in Right arm on 07Feb2021 at 14:00 (at the age of 82-year-old) as 1st dose, single for covid-19 immunisation. The patient Medical history included cough from 19Jan2021 to an unknown date, dyspnoea from 19Jan2021 to an unknown date, malaise from 19Jan2021 to an unknown date. On the 19Jan2021, she was not feeling well and went to a medical facility and had blood work, a chest x-ray, and a Covid-19 swab done. They said that she probably had Covid, but they weren't sure. She was sent to another facility and had a antigen test. Her swab came back from the swab test a few days later and came back positive. On the 20Jan2021 they did a throat swab and it came back negative that she did not have Covid-19. She went back to the first facility about 10 days later and they did another throat swab and she tested negative. The concomitant medications were not reported. No 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). No Prior Vaccinations (within 4 weeks). The patient was not ill at the time of vaccination. On 08Feb2021, the patient experienced splitting headache, felt terrible, Trouble walking. The reporter stated that the Covid-19 Vaccine and reported that she had the vaccine on 07Feb2021 and on 08Feb2021, she was feeling so horrible that she went to her physician. She said that she had a splitting headache and does not know if it is associated with the vaccine. It is Thursday, and she still has a headache, shortness of breath, and she just feels terrible. The patient reported that she also had cough. She said that she can't do her daily activities and she feels out of sorts. She feels like she does not want to do anything and the headache hurts. She does not know if it is a migraine or what, but it hurts. She reported that she has been having trouble walking. She stated that this started this past week since she had the vaccine, since 08Feb2021 and stated that it is persisting. The headache is driving her crazy. The adverse events resulted to visit physician office. They prescribed her a Z-pack of Azithromycin and an albuterol Inhaler. The outcome of the events Splitting headache, She just feels terrible, Trouble walking were not resolved and other events were unknown. Follow-up: Follow-up attempts completed. No further information expected.

Admitted to hospital testing positive for COVID after being fully vaccinated. Patient admitted 05/29/21 with a GI bleed, patient asymptomatic for COVID s/s but was tested following hospital admission policies and had a positive PCR test on 05/29/2021. Patient reports her husband was positive for COVID a few weeks prior. Patient treated for GI bleed and d/c'd home on 05/30/2021. She returned to the hospital same day within a few hours reporting dizziness, syncopal episode, and slurred speech per medic. Admitted again with a-fib with RVR. No fever or cough, did report some shortness of breath at home. Discharged on 06/04/21, then readmitted for a-fib with RVR again, discharged home with homecare on 06/14/21.

The day after the second shot i had a low grade temperature of 99.3, Severe muscle aches, and very tired. I began to have huge amounts of blood mucus, spitting it up and choking on it. Was given a sinus infection amoxicillin antibiotic and musilix and nasal sprays. 2 weeks The heavy blood mucus traveled into my eustachian tubes, imparing my hearing and making me off balance...3 weeks. Experienced sever headahce for a week and went to ER for Ct scan . No stroke or anyerism . Then the heavy bloody mucus went into my bronchi and lungs causing shortness of breath and weakness...given a pneumonia antiibiotic . I am currently on a prescription for Prednisone ( on the refill) and improving slightly but still weak and tired and shortness of breath. Still having shortness of breath (6/26/21_ and very tired. Cannot perform all my daily functions like taking a walk . I am able to prepare meals. adverse reaction still exits 2/25/21 - 6/26/21

She noticed some shortness of breath upon exertion, especially after her walk; I am not sleeping well, but I don't sleep well anyway and don't think it's related to the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 83-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 28Feb2021 at 13:20 (at the age of 82-years-old) (Batch/Lot Number: GN6202) as DOSE 1, SINGLE for covid-19 immunization. Vaccination facility type was Physician Office. Vaccine was not administered at Facility. The patient's medical history was not reported. Concomitant medications included a lot of unspecified pills. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Patient had no other vaccines on the same day as the suspect product. Prior Vaccinations (within 4 weeks) was none. Patient stated after her first vaccine dose, over last 5 days on an unspecified date in Mar2021, she noticed some shortness of breath upon exertion, especially after her walk, she wanted to know if it was normal because it only occurred during exertion. Patient also stated that other than that I haven't had any side effects, I am not sleeping well, but I don't sleep well anyway and don't think it's related to the vaccine, she also stated her second dose was scheduled on the 24th day instead of 21st day. Patient stated that she was prescribed an inhaler by her doctor a couple years ago, but she never used it before, but she tried using it yesterday but she did not know if it helped or not, since she only felt the shortness of breath when she was doing a brisk walk. The patient would call doctor will call she would probably just tell me to take my inhaler.Caller states that she noticed that when she takes her 30 minute, daily walks, she is getting some shortness of breath. Caller states that she got her Pfizer COVID vaccine shot, a week and a half ago, and she is wondering if that could be a side effect of the product, or if it is a symptom of COVID. The events did not result in emergency room/ physician office visit. The patient was not admitted to hospital due to events. Relevant test reported as none. Therapeutic measures were taken as a result of she noticed some shortness of breath upon exertion, especially after her walk (dyspnoea exertional). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

had previous shortness of breath but got much worse after vaccination, heaviness in chest, extreme fatigue and weakness, wheezing in chest, fuzzy eyesight, can't focus eyes, feels as if eyes are going cross-eyed, muscle weakness, trouble walking, previously had headaches but more frequent and worse since vaccination

83 y/o female, PMHx of Afib, HTN, DM, colon CA, presenting with worsening SOB and weakness related to Covid19 infection. Pt was diagnosed with Covid on 1/22/21 and managed symptoms at home. Was sent to ER by home health due to low O2 sat without oxygen. Hypoxic at 86% on admission. Pt treated with supportive measures. Pt was discharged to skilled nursing facility on 2/1/21.

After 2nd vaccination - patient was having trouble breathing whenever she worked out in the yard doing minor task such as raking leaves/gumballs. She had 3 or more episodes of feeling light-headed and stopping activity and walking into living room and sitting. Was able to catch breath and didn't want to go to hospital in any of these cases. However on March 8 at 3pm, she felt light-headed but on her way back to her living room, her breathing was disrupted. Her breaths were cut short and she was not receiving much air into her lungs. The breaths were shorter and shorter until she wasn't receiving hardly any air into her lungs. Her face turned blue. She passed out. She had CPR administered about 30 seconds after passing out. Ambulance arrived about 1 minute after passing out. EMT crew worked on her for 18 minutes and was ready to contact coroner when they got a heartbeat. She was taken to hospital on March 8. She was transferred to another hospital later than night. She was sent home for hospice (still unconscious) on March 16 or 17. She passed morning of March 19. Death certificate states cause of death was lack of oxygen to the brain, but no determination was made to what caused her breathing problems, which caused the lack of oxygen to her brain. EMT crew said her symptoms were very similar to blood clot in lungs. Hospital ruled out a blood clot. They also downloaded data from the pacemaker and ruled out A-Fib as the cause. Pacemaker data had indicated a mild event around 3pm on March 8 and sent a shock to her heart but nothing unusual. I believe the hospital also ruled out another cause or two, but never did determine the cause.

83yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, the patient reportedly got up in the middle of the night with c/o feeling "blah", restlessness, and nausea. VS normal, no other s/sx. At 4:15am, the patient was asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient unresponsive, no pulse, no respirations. GNA notified the nurse. At 6:03am, CPR started and EMS called. At 6:15am, EMS arrived and took over. At or around 6:30am, EMT called time of death

Tinnitus Tremors Diaphoresis Sob Epipen given, paramedics called, sx resolved 20 minutes after sx onset

had trouble breathing; toung was greatly swolen; This is a spontaneous report from a contactable consumer (patient) reported that an 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiration date: not reported), via an unspecified route of administration in the left arm on 11Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included very mild chronic obstructive pulmonary disease (COPD) from an unknown date. Concomitant medications included sertraline, temazepam, levothyroxine and pravastatin. It was reported that on 11Jan2021, the patient had injection at 9:30 am then at 6 pm, had trouble breathing and tongue was greatly swollen (reported as "toung was greatly swolen"). The patient called ambulance and went to emergency room/department or urgent care. As treatment, the patient received saline IV, banophen and prednisone. The outcome of the events was not recovered.

12:10 PM - Patient honked horn and RN responded. Pt lightheaded, short of breath. "Chest felt heavy." 12:16 PM - 911 called, vitals (BP 140/76, Pule 50, RR 20, Ox 93%) 12:19 - EMS on scene. Pt still short of breath but talking, vitals remained stable. Pt c/o headache. Pulse ox 94-95% 12:30 - Pt transferred to hospital for cautionary monitoring

Shortness of breath, rapid heart, nervous, oxygen dropped I had to rush her to Emergency Room at hospital. She was placed on oxygen, giving multiple breathing treatments, rocephine, and steriods.

Client's son reports that client complained of throat tightness, new onset coughing. Client was treated on site by Fore Rescue and transported to Hospital by ambulance.

Two nights later woke up not feeling well, trouble breathing. Increased oxygen next day. Returned oxygen level to normal following day and oxygen appeared okay. The next day, so five days after vaccine, had trouble breathing again and high blood pressure. Admitted to hospital and diagnosed with pneumonia. Currently hospitalized.

Lost consciousness, couldn't breathe, Kidney GFR dropped. Fluid in the lungs, Kidney damage. Still in hospital. No diagnosis at this time.

Patient reports she received vaccine at 10:10 a.m. in the morning. At about 1237 at night she woke up feeling throat swelling and increased wheezing. She took 50 milligrams of Benadryl and got up and walked around. She reports that her symptoms resolved after about 30 minutes and she went back to bed without any difficulty. She has had a previous history of anaphylactic reaction to atenolol and chlorthalidone, which do not appear to have a cross reaction to the vaccine. She is wondering if she should cancel her 2nd vaccine appointment and is concerned that she may not have full immunity with only 1 vaccine dose. Dr. recommends that she not receive the 2nd dose of COVID-19 vaccine.

--Patient (and patient's husband) report that patient was given 2 doses of Pfizer Covid 19 vaccine 6 days apart at the Health Department. --First dose: 2/3/21. Second dose: 2/9/21 --Patient was admitted to hospital on the evening of 2/9/21 with weakness, shortness of breath "feeling winded". --Patient reports feeling bad and coughing 2-3 days before being vaccinated and does NOT believe her admission to the hospital was associated with the vaccine. --County health department has been notified.

RECEIVED PFIZER COVID VACCINE ON 02/04/2021 REPORTED TO ED ON 02/13/2021 WITH NECK/BACK PAIN, DIFFICULTY SWALLOWING, SORE THROAT, SOA, WEAKNESS/TINGLING IN BLE. ADMITTED ON 02/13/21 FOR DIAGNOSIS OF WEAKNESS, HYPOKALEMIA, CARDIAC ENZYMES ELEVATED, CHF, AND LEUKOCYTOSIS.

Left jaw visible swelling, and perceived left side of tongue and left side of throat "felt swollen"; this occurred at 2 am, 17 hours post vaccination, and again a week later at 11 pm at night; both times symptoms did not impared breathing or swallowing and resolved after taking Benadryl, sipping water, and gargling with salt water

respiratory distress; covid test result: Positive; This is a spontaneous report from a contactable consumer. An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 19:00 at single dose for covid-19 immunisation. The patient medical history was not reported. No other vaccine in four weeks. There were other medications in two weeks. No COVID prior vaccination. No Known allergies. The patient experienced respiratory distress on 09Jan2021 12:00. Patient was taken to hospital then released week later and currently readmitted with respiratory distress. Treatment received for the events. Nasal Swab Covid test post vaccination on 11Jan2021: result Positive. Outcome of events as not recovered. Information on the lot/batch number has been requested.

elevated blood pressure; had trouble breathing; Pneumonia; didn't feel well; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 04Feb2021 10:30 at single dose for COVID-19 immunization. Medical history included diabetes, chronic obstructive pulmonary disease (COPD), high blood pressure, high cholesterol, and prior lung cancer. The patient was not pregnant. The patient had no known allergies. Concomitant medications included insulin detemir (LEVEMIR), metoprolol, umeclidinium bromide, vilanterol trifenatate (ANORO ELLIPTA), metformin, levothyroxine, saxagliptin hydrochloride (ONGLYZA), and atorvastatin. The patient received first dose of bnt162b2 on 14Jan2021, 10:30 for COVID-19 immunization. It was reported that 2 nights following vaccine, patient had trouble breathing and didn't feel well on 07Feb2021, 12:30. Patient started to feel better but again two days later, she had trouble breathing and elevated blood pressure on 09Feb2021. Patient was admitted to the hospital for 2 days due to the events on an unspecified date and was diagnosed with pneumonia. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. There was unspecified treatment for the events. It was reported that patient was currently hospitalized. The patient did not have other vaccine in four weeks, no covid prior vaccination and was not covid tested post vaccination. Outcome of events was not recovered. Information on the lot/batch number has been requested.

Received 1st dose of covid vaccine on 2/3/21, 2nd dose on 2/24/21, admitted to hospital on 3/1/21 with acute respiratory failure/COPD exacerbation, tested negative for COVID, afebrile, vitals wnl, no signs for bacterial/viral infection.

coughing white mucus 3 days after vaccine, fatigue day 1, shortness of breath on 2/24, 2/26 severe shortness of breath, admitted to er on 2/26

Pt. reported feeling SOB with exertion 20 minutes after receiving second dose of COVID 19 vaccine. Pt. was speaking in full unlabored sentences without obvious signs of increased work of breathing. ACC provider was called to assess and ordered MDI albuterol inhaler/ spacer. Pt. ambulated and was able to maintain Sa02 of 97% while ambulating. Pt. was observed for 60 minutes and discharged home with grand daughter in no apparent distress and reported improvement of dyspnea. Pt. did report that she routinely has "sudden" onset of SOB with ambulation and this was not unlike previous episodes other than having just had vaccine administration.

Pounding in head; Heart pounding; Elevated BP; bouncing off the walls, and going from side-to-side when she tried to walk; oxygen saturation level kept dropping; shaking; cold; Weakness; Tiredness; Throat tightness; Dry mouth; This is a spontaneous report initial from a contactable nurse and follow up from a Pfizer-sponsored program. This Nurse (patient) reported for self that the 83-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on 17Feb2021 09:30AM on right arm at single dose for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing Reported she was diagnosed with Rheumatoid Arthritis about 10 years ago, fibromyalgia from an unknown date and unknown if ongoing and stated when the doctor couldn't figure out what was causing her pain, the doctor said she had Fibromyalgia, carotid endarterectomy from 2014, pain in extremity from an unknown date and unknown if ongoing She said she has rheumatoid arthritis, and has had terrible leg pain for a long time. Family Medical History Relevant to AE(s) was not provided. Concomitant medication included cortisone (CORTISONE) for Pain in leg from 10Feb2021 and stated her doctor gave her a Cortisone shot in her right knee to help with her right leg pain. Reported she received a Cortisone shot in her right knee on Wednesday, 10Feb2021. She said the doctor gave her the Cortisone shot in her right knee to see if it would help her right leg pain. She said she has a problem with Cortisone, clarifying the Cortisone keeps her awake. She said the doctor wanted her to have another Cortisone shot in 3 months, and she is not going to take the Cortisone shot because she doesn't like how the Cortisone makes her feel. The patient experienced pounding in head (hospitalization, medically significant), heart pounding (hospitalization, medically significant), elevated bp (hospitalization, medically significant), bouncing off the walls, and going from side-to-side when she tried to walk (hospitalization, medically significant), dry mouth (medically significant) all on 17Feb2021 with outcome of recovering, throat tightness (medically significant) on 18Feb2021 with outcome of recovering, weakness (medically significant) on 19Feb2021 with outcome of not recovered, tiredness (medically significant) on 19Feb2021 with outcome of not recovered, oxygen saturation level kept dropping on an unspecified date with outcome of unknown, shaking on an unspecified date with outcome of unknown , cold on an unspecified date with outcome of unknown. He experienced terrible pain in the leg after the 1st dose and took a marijuana cookie and she was rushed to the ER because she was shaking and cold. The patient was hospitalized for events pounding in head, heart pounding, elevated bp and bouncing off the walls, and going from side-to-side when she tried to walk from 17Feb2021 to 18Feb2021. The nurse states that "I told her up until a Month ago, she was taking care of a huge house and husband that is blind. I've been having the pain in my legs for over a month, doppler was done, and I had an injection in my knee with cortisone, I won't do that again, it keeps me awake at night. There is no diagnosis yet on the pain, have an orthopedic appointment coming up. Caller states, I got the first Pfizer vaccine shot on Wednesday at 9:30 am in right arm. Never so much have felt it. or have not felt anything else since. My friend talked me into eating a marijuana cookie about 5pm that day, and at 6 or 6:30pm, I started feeling terrible, my head was feeling terrible, my heart was pounding, I could hardly walk, my mouth was dry as a bone. we called paramedics, we found out on Friday before the shot that I have a right bundle block. Woke up 4:30 in the morning the Friday before with chest pain. EKG found right bundle block, my blood pressure was 245/105, that night in the ER, they got my blood pressure down and sent me home. Wednesday, I had the covid shot in right arm, at 9:30am, that day about 4:30 - 5:00 had the cookie thing, about 6pm, had to call the paramedics, they kept me in the hospital overnight. because my oxygen saturation kept dropping, down in the 86% or 89%, I don't know. Gave me breathing treatments, CT scan for blood clots in lungs was done, Doppler for blood clots in legs, and a HgbA1C. They did an echo of my chest. I don't know all of the results yet. Even yesterday, in the hospital I felt better, but feel week and tired, while walking the hall in the hospital my Blood pressure went up a little bit. I told the nurse, my head feels like this when my blood pressure is up. They sent me home last night. Today, I am feeling okay. My mouth is still a little dry, got a little better yesterday. My legs are still killing me, I have an appointment with my Cardiologist and Rheumatologist, I have Rheumatoid Arthritis. My question is , the doctor didn't know if it was from the cookie or from the vaccine. I am wondering if I should get the second vaccine." She stated she never had a sore arm after getting the COVID-19 Vaccine. She said she did something stupid after she received the COVID-19 Vaccine. She said she has rheumatoid arthritis, and has had terrible leg pain for a long time. She said her friend talked her into having a cookie that had marijuana in it. She said her leg pain was so severe at the time, she took the cookie with marijuana in it around 4:30PM-5:30PM on 17Feb2021. She said at 7:00PM she was bouncing off the wall (clarified as unsteady, and going from side-to-side when she tried to walk), her head was pounding, her heart was pounding, she was dizzy and shaky. She said she went to the hospital emergency room. She said the hospital kept her overnight because her oxygen saturation level kept dropping. She said she got home from the hospital last night (18Feb2021), clarifying she was discharged from the hospital at 6:00PM. She said she noticed her mouth was very dry when she went to the hospital on 17Feb2021, and her mouth continued to stay very dry all night. Caller asked if she should get the second COVID-19 Vaccine shot after experiencing what she did after receiving the first COVID-19 Vaccine. Reported her leg pain became severe about a month ago, clarifying she has had leg pain for a long time. Reported her blood pressure was up while she was at the hospital, clarifying she had one blood pressure reading of 145/82 that she recalls. She said her blood pressure is pretty normal, and she takes blood pressure medications. She said she believes her heart rate was up too, but was unsure what her heart rate was. Reported a couple days before receiving her first Pfizer COVID-19 Vaccine, she went to her doctor on 12Feb2021 because she was having severe chest pain. She said her doctor did an EKG and told her she had a right bundle branch block. She said her doctor sent her to the hospital Emergency Room. She said while she was in the Emergency Room she had an extremely high blood pressure of 245/105. She said she came home from the Emergency Room on 12Feb2021, and had a couple spells, but was OK. She said she was OK when she went to get her first COVID-19 Vaccine shot on Wednesday, 17Feb2021. Reported she had difficulty reading her COVID-19 Vaccine Immunization Card. She said the Pfizer COVID-19 Vaccine Lot Number looked like EN6200, and there was no NDC Number, or Expiration Date listed on the card. Reported she had blood work done at the hospital. No further details provided. Treatment included she was given Albuterol breathing treatments while in the hospital, along with some other things that she can't remember. Reported she believes her symptoms were medically significant because she was nervous from recently being to the Emergency Room for her severe chest pain a few days before. Reported she did not think her symptoms were from the COVID-19 Vaccine. She said she thought the cookie with marijuana in it caused her symptoms because the symptoms happened about 1-1/2 to 2 hours after she had the cookie with marijuana in it. Reported she feels very weak and tired. Reported yesterday (18Feb2021) while she was in the hospital, her head felt like it was going to explode when the hospital staff tried walking her around. She said she asked the hospital staff to check her blood pressure because her head will feel like that when her blood pressure is up. She said when the hospital staff checked her blood pressure, her blood pressure was elevated. Reported the pain in her legs is driving her crazy, so she called for an appointment with an orthopedist today. Reported she is feeling better, but is still experiencing a tightness in her throat. She clarified she felt the throat tightness on Wednesday, 17Feb2021. She said she has no problem swallowing or eating, but her throat feels tight. Vaccination Facility Type was Hospital. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. AE(s) required a visit to: Emergency Room (admitted to hospital), no Physician Office. Prior Vaccinations (within 4 weeks) was none.; Sender's Comments: The 83-year-old female patient had medical history included rheumatoid arthritis, fibromyalgia and carotid endarterectomy, and was on multiple concomitant drugs. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of the reported events, cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

visits on 2/16/20 positive for influenza B, admitted she has been having a productive cough of brown sputum, dyspnea, fever/chills, poor appetite, body aches since roughly 7-10 days ago which would be about the time of her 2ND COVID Vaccine. Also had visits on 2/23,3/01 for similar complaints. Tested negative for SARS COV-2 through PCR on 3/1/21. tested positive on 3/7/21 through PCR.

she is short of hearing; losing her breathe; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown) via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunization. The patient's medical history included: Stage 3 lung cancer, radioactive therapy on 25Dec2020 to 31Dec2020 (Also reported as 2-days prior to her 1st vaccine shot, the nurse gave her 2 radioactive therapy and the last one was 31Dec2020), immune therapy on 01Jan2021 (7 weeks' worth received all in 7 days), and steroid therapy on December 2020 and Jan2021. The patient had terrible reaction from the immune therapy on an unspecified date which include all the skin of her mouth had ulcers, had such sickness, diarrhea, a rash all over the face, had headaches, was so fatigued, no energy and could not get out of bed. Patient felt better in the past few days. Other medical history included had a bad fall, two broken ribs and needed hip replacement surgery from unspecified dates. She lives alone and received 700 units a day of steroids for 10-days last December. Family history included lung cancer runs in her family (sister and brother died of lung cancer, other sister got it too). Patient stated her doctor called her in 2 days before and stated her next step was immune therapy, she has had massive doses of radioactive before, she had 7 weeks of that in 10 days, and had an extreme reaction from that, the last one was 31Dec2020. Concomitant medications were not reported. The patient stated she refused her immune therapy, as she wanted the vaccine. It was put down as she did not want it. The patient reported that nurse there then said she was going to be put on unspecified steroid, which she never had before. Her friend picked up the prescription and, without reading everything, and she usually does, she took two of them. It said take all 6 that evening, but she took 2 then read and it said not to take with any vaccine. She stated that the nurse knew how she stressed she wanted the vaccine, and so she had the COVID vaccine. She just had the two steroids, and she said she wanted to wait until Mar2021 until she considered getting immune therapy, but the nurse booked her for 26Feb2021, and she had her second vaccine from Pfizer scheduled on 19Feb2021 one week apart. She asked if that is too soon, and does she need to put off immune therapy again. She read it is 2-3 weeks between, she wanted to have this verified. Patient stated she supposed to take 6 steroids then 5 and so on. She took 2 pills then as she was reading information regarding the vaccine, she did not take anymore. Last week is when she took the two steroids, she won't take them. She called a pharmacist, who said do not take them. The doctor's office, the nurse, gave them, after she told them she would have the vaccine. She stated she was furious, but she was getting this all the way down the line. She put the steroids away, she said she was not taking them, she talked to someone in the medical field and told her how she felt, and she agreed. Patient asked if it will be ok to have the immune therapy at that time and soon after getting the vaccine if it would be effective. She mentioned that at her age she is more concerned that she gets that vaccine and she wants to delay having the immune therapy until March given the horrible reaction she had before. She tried and tried to have this conversation with her doctors, but she does not have all that technology and they are only offering remote appointments. Patient stated that she had no problems from the first dose of the vaccine stating she did not even feel the needle. She has been exactly an hour on the phone. The patient stated that she was losing her breathe after speaking at this time during the call on 05Feb2021. She also stated she is short of hearing (onset date unknown). Outcome of the events was unknown. Information on the lot/batch number has been requested.

Progress Notes Expand AllCollapse All 3/12/2021 Patient: DOB: 4/18/1937 Date: 3/12/2021 MRN: Subjective Patient is a 83 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 lightheadedness, sensation of sob. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, increased swelling, rapid progression of symptoms and respiratory distress. Past Medical History: Diagnosis Date ? Adnexal mass ? Atrial flutter (HCC) ? AV nodal ablation on 6/19/14 6/20/2014 ? Biventricular pacemaker (Medtronic) implanted on 6/19/14 6/20/2014 ? Chronic venous insufficiency ? Glaucoma ? History of mitral valve replacement 10/10/2006 29 mm Mosaic Porcine Bioprosthesis ? Hypertension ? Hypothyroidism ? Long term (current) use of anticoagulants COUMADIN - HAD TOO MUCH LOVENOX 2011 & HAD BLEED ? Nonischemic cardiomyopathy (HCC) ? Osteoarthritis ? PAF (paroxysmal atrial fibrillation) (HCC) ? PVC's (premature ventricular contractions) ? Systolic congestive heart failure with reduced left ventricular function, NYHA class 2 (HCC) ? Varicose vein Hx of covid, hospitalized for 5 days in December 2020. ALLERGY REVIEW OF SYSTEMS: Patient complains of shortness of breath (sensation, briefly) Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, dizziness and headaches + lightheaded: Previous Reactions: none Objective Vitals Vitals: 03/12/21 0925 03/12/21 0935 03/12/21 0943 BP: (!) 146/75 (!) 157/69 136/78 Pulse: 97 68 68 SpO2: 97% 99% 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No facial asymmetry. Sensory: Sensation is intact. Motor: Motor function is intact. Coordination: Coordination is intact. Gait: Gait normal. Comments: + 5/5 strength to upper and lower extremities. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: water and snacks Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns) Lightheaded. Resolved with snacks and water. Pt to monitor bp at home. Follow up with pcp. Pt wheeled out to her daughter's car by RN. Pt and pt's daughter voiced appreciation of care today.

Ground Glass Opaque lung problem; Weak; nausea; diff.breathing; pain on rt.side waist around to back,down to lower belly; slight temp almost 100; pain on rt.side waist around to back,down to lower belly; pain on rt.side waist around to back,down to lower belly; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Left Arm on 22Jan2021 10:45 am as SINGLE DOSE for covid-19 immunisation. Medical history included overweight, sleep apnoea syndrome and ongoing shortness of breath. Concomitant medication included levothyroxine strength 125 mcg; triamterene; colecalciferol (VIT.D3) and thiamine (VITAMIN B1). The patient previously took tylenol and experienced drug intolerance (Known allergies: Cannot tolerate anything but Tylenol). No other vaccine in four weeks. Facility type vaccine was Workplace clinic. The patient experienced weak (asthenia) on 23Jan2021 15:00, nausea on 23Jan2021 15:00, diff. breathing (dyspnoea) on 23Jan2021 15:00, pain on rt.side waist around to back, down to lower belly (pain) on an unspecified date in 2021, ground glass opaque lung problem (lung opacity) on an unspecified date, slight temp almost 100 (body temperature increased) on an unspecified date in 2021 and pain on rt.side waist around to back, down to lower belly both on an unspecified date in 2021. AE resulted in [Emergency room/department or urgent care]. Treatment was received for these events (Levofloxacin 500mg). It was reported that Weak, nausea, diff. breathing, urgent care on Fri. 05Feb2021, with pain on rt. side waist around to back, down to lower belly. Contrast Cat Scan showed no signs where pain was, but found Ground Glass Opaque lung problem. Is it safe to take #2 vaccine I'm on oxygen now, slight temp almost 100, usually 97. There was no covid prior vaccination. Patient has covid tested post vaccination as SARS-COV-2 test: negative (Nasopharyngeal) on 05Feb2021. The outcome of events was not recovered.

My mother called me when she was going to get her second vaccination. She was alive and well and living independently at her home. She could walk, talk, make her own food, wash and dry her own clothes and take her own baths. After taking the second vaccination she went down hill. She became sicker and sicker and eventually she started coughing up blood. She decided to go to the hospital, another Hospital of facility. I don't know what the treatment was at that hospital but she was soon transferred to facility and that is where I was notified she was in the hospital and visited her there. After arriving they intubated her and said she had blood clots in her brain and heart. When I saw her after she transferred from Hospital to the Hospital I noticed one arm was swollen. Her legs were as they have been for the last 20 years and looked okay to me--no discoloration other than her regular discoloring at one right ankle and the same old same old slight swelling in the left ankle. The doctors and nurses were putting the blame on her legs but you could tell things were happening else where. But as she got worse and worse at the hospital her right arm become more and more swollen with dark bruises appearing--the hospital staff took pictures. The left arm continued to swell and did not look normal at all. She apparently had bleeding in her left lung from a blood clot. She had three areas of her brain that add clots and some bleeding. She was constipated and gaseous when they cleaned her. They didn't treat her constipation which made being intubated worse because I feel that caused her intestines to swell, thus she also had bleeding in her intestines. My mother died on March 17, 2021 at hospital in ICU. I was told they could not treat the blood clots because of the bleeding in her lung, intestines and brain.

progressive shortness of breath; hypoventilation; dysphagia; severe asthenia; mild upper abdominal pain; inability to eat; This is a spontaneous report from a contactable physician. An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 14Feb2021 (at the age of 83-years-old) as a single dose for COVID-19 immunization. Medical history included right partial nephrectomy for renal cell carcinoma (RCC) in the remote past, hypertension, obstructive sleep apnea, hypothyroidism, morbid obesity, motion sickness, unspecified allergy as the patient cannot tolerate anything but paracetamol (TYLENOL), acute on chronic respiratory failure secondary to centrilobular emphysema. Ongoing concomitant medications included levothyroxine sodium (LEVOXYL) tablet, meclizine hcl tablet for motion relief and hydrochlorothiazide/ triamterene (DYAZIDE) capsule. The patient previously took paracetamol (TYLENOL). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247) on 22Jan2021 (at the age of 83-years-old) in the left arm and experienced difficulty breathing, ground glass opaque lung problem, weak, nausea, "pain on rt.side waist around to back, down to lower belly", slight temp almost 100. On an unspecified date in Feb2021, the patient presented to the hospital with progressive shortness of breath and inability to eat for two days. The patient reportedly received the second dose of BNT162B2 four days prior to coming to the emergency room (ER). In the ER, the patient reported severe asthenia, mild upper abdominal pain and dysphagia, all as of an unspecified date. The patient underwent a CTA in the ER, on Feb2021, which showed no acute pulmonary embolism, or no ground glass infiltrates. The patient was admitted to the hospital on 21Feb2021 at 17:51 for management of worsening shortness of breath. Due to the patient's acute on chronic respiratory failure secondary to centrilobular emphysema and obesity, hypoventilation (as of an unspecified date in Feb2021) was further complicated by obstructive sleep apnea, thus, the patient was admitted to "MedSurg". The patient did not present with COVID-19 or COPD. The BMP was 226 at the time of admission. The patient was started on supplemental oxygen and additionally started on CPAP at night. She was seen by a pulmonologist who recommended Salmeterol Xinaf/ fluticasone (ADVAIR). Pulmonology also recommended to work-up any underlying unaddressed coronary artery disease contributing to the patient's shortness of breath. The patient underwent an echocardiogram on Feb2021 with regadenoson (LEXISCAN) for her shortness of breath which was within normal limits. As the patient additionally reported dysphagia at the time of admission, she was evaluated by a speech and swallow evaluation specialist as well as a gastroenterologist. A GI swallow series was recommended which the patient underwent on Feb2021 and was found to have no active signs of oropharyngeal or esophageal dysphagia. The patient additionally underwent a physical exam on 24Feb2021 at 08:00 with the following results. Vital signs: Temp: 98.2, Pulse: 69, Resp: 17, B/P (MAP): 98/62 (74), Pulse Ox: 96, O2 Delivery: Nasal cannula, O2 flow rate:2.00. HEENT: Pupils equal round reactive light accommodation, no lymphadenopathy noted, neck vens were apple. CVS: S1-S2 normal, no appreciable murmur rub or gallop noted. Respiratory: Good Inspiratory effort, good air entry bilaterally, no rhonchi, Rales or wheezes heard. Gl: Abdomen soft, nontender nondistended, bowel sounds heard, no organomegaly detected. Extremities: Bilateral lower extremities Shaw no edema, bilateral dorsalis pedis 2+, skin appeared intact. Neurological: Patient alert and oriented x3, strength 5x5 in all 4 extremities, no signs of focal neurological deficits. Skin: No clear breakdown or rashes noted. The patient was being discharged home on 24Feb2021 at 08:04 with a CPAP machine. The patient was prescribed Cefuroxime axetil (CEFTIN) 250mg Tablet orally twice a day; Salmeterol Xinaf/ fluticasone (ADVAIR) 250-50 diskus 1 puff twice a day for progressive shortness of breath and hypoventilation. The patient had been advised to follow-up with a pulmonologist for an outpatient pulmonary function test. The clinical outcome of progressive shortness of breath, hypoventilation, inability to eat, dysphagia, severe asthenia and mild upper abdominal pain was unknown. The reporting physician considered that BNT162B2 had no causal effect on the events reported. Information on the lot/batch number has been requested.; Sender's Comments: In agreement with the HCP reporter, the reported events do not appear to be related to the subject vaccine. The events likely represent intercurrent medical conditions, possibly associated with the patient's history of emphysema. 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.

Within 15-minutes of vaccination, the patient reported lightheadedness, nausea, and dry mouth. EMS evaluated the patient on-site. The patient stated they were currently taking Augmentin for a UTI. Patient was hypertensive (162/82) with a FSBG of 84 mg/dl. EKG demonstrated NSR, rate 99bpm, no ST elevation. EMS administered 250mL IV saline en-route to Emergency Department. In the ED, the patient reported lightheadedness, nausea, dry mouth, left arm injection site pain, and feeling like her throat was closing. Patient remained slightly hypertensive (144/81). Physician administered 1L IV saline bolus and 10mg IV Decadron. The patient was discharged with diagnoses of Dizziness and Vaccination reaction.

Severe Sore Throat; Stiff neck; Shortness of breath; Back ache; every bone and every part of her body hurt; every bone and every part of her body hurt; pain under her ribs; weak and shaky; weak and shaky; biceps ached; Fatigue; tremendous headache; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 28Mar2021 14:00 (Batch/Lot number was not reported: did not get a card that lists NDC, Lot, Expiration) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. It was also reported that no additional vaccines were administered on the same date. The patient did not require visit to Emergency Room and stated that she was desperate and would've gone but she didn't have a ride and added she is worried about the second. Also, the patient did not required visit to the physician's office. No prior vaccinations (within 4 weeks). No family medical history. The patient reported that she received the first dose of the vaccine and 5 days later she got a terrible reaction. She did not expect it. She had a terrible reaction and thought she was going to die. She stated she wanted to report this because the TV says you should expect some kind of reaction after the second dose but does not say after the first and she said that Pfizer needs to know about this reaction. She stated she heard the second dose is worse. The patient asked if she has to get her second dose and if she needs to report this anywhere else? The patient added "what should I do about side effects?" It was reported that the patient (reported as is almost 84) had the first shot on Sunday 28MAR2021 and everything was fine by Friday she was in terrible trouble really really bad. States she has never heard of this, they say the first is easy and everything was terrible. States every bone and every part of her body hurt on 02Apr2021. She states after 24 hours (03Apr2021) it did go away. The patient asks does this happen to other people? It was stated that her symptoms came on suddenly and she had a severe sore throat, stiff neck, back ache, pain under her ribs, very very weak and shaky, shortness of breath, biceps ached, fatigue, and a tremendous headache. It was stated that started on Friday 02Apr2021 12:00 like a hurricane and after 24 hours they subsided on Saturday 03Apr2021. The patient added that she doesn't remember getting a card and didn't know that she should have a card until she saw something about it on TV, and thought well she didn't get a card. The patient also asked what does she do about that? The patient states she takes medication but not that affects this. The outcome of the events recovered on 03Apr2021. Additional information has been requested

Patient c/o nausea, vomiting, diarrhea and dyspnea for 2 days. Resident of assisted living facility, presented to emergency department of local hospital where she was admitted for COVID pneumonia.

Patient had a vasovagal episode. She stayed sitting in chair, but her head was flexed forward and wasn't taking obvious breaths. After lifting her head, she took some deep breaths and opened her eyes. She had similar episodes with fainting. EMS was called.

This 83 year old female received the Covid shot on 1/28/21 while under hospice care and went to the ED and admitted 2/4/21 and again on 3/3/21 and again on 3/25/21 and 4/15/21 died on 4/24/21. GI bleed, duodenal ulcer with hemorrhage, SIRS (systemic inflammatory response syndrome, shortness of breath, acute heart failure, acute respiratory failure, cough, pleural effusion. 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 conditions (leg swelling, coughing) get deteriorated after the vaccination. She was found pericardial effusions and plural effusions 2 weeks after the second dose. She stayed in ICU for 6 weeks and passed away.

PATIENT DEVELOPED FEVER, WEAKNESS, DYSPEA, NAUSEA, VOMITING, DIARRHEA, WITH AN O2 SAT OF 80% ON ROOM AIR AND RESPIRATORY OF RATE OF 40. PATIENT TESTED POSITIVE FOR COVID 19 AND WAS HOSPITALIZED, LATER PLACED IN ICU

Pt brought via EMS to ED for SOB & chest pressure on deep breathing w/cough. Pt was hypoxic on room air at 82% but responded w/2L O2. Testing revealed mildly elevated lactic acid (2.5, likely due to metformin) and mildly elevated BNP (223) and a positive COVID test. UA showed some bacteria and leukocyte esterase, but no UTI symptoms. Pt had received both Pfizer vaccine (1/15/21 & 2/6/21). Was admitted for additional management of acute hypoxemic respiratory failure with COVID-19 due to oxygen needs. Was treated w/dexamethasone, remdesivir and sepsis was ruled out. Ceftriaxone was given in ED for asymptomatic bacteruria. Pt ultimately discharged 3 days later with pulse oximetry for home use.

Presented to ED w/hx of harsh, nonproductive cough (4/7) & subsequent positive COVID-19 test (4/13) despite receiving Pfizer vaccines (1/21 & 2/16). Continued to have worsening cough w/occasional SOB, generalized weakness affecting daily activities and poor oral intake. Found to be febrile, hypotensive w/increased confusion. Imaging revealed opacity of R middle lobe & bilateral lower lobe consolidation concerning for pneumonia. Was admitted for additional management of sepsis & acute hypoxic resp failure secondary to COVID-19 on 4/22. Treated w/dexamethasone & started on ceftriaxone for asymptomatic Ecoli UTI. Pt ultimately discharged (4/29) w/extended antibiotic course for MSSA bacteremia w/ID follow-up on 5/24

Cough Chest congestion; Phlegm in throat; Fatigue; Encouraged to continue with the Mucinex; Encouraged Tylenol for aches pains and fevers; Encourage plenty of fluids.

This is a spontaneous report from a contactable consumer (patient). An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as a single dose (at the age of 83-years old) for COVID-19 immunisation. Medical history included the patient had known allergies (unspecified) and unspecified chronic health conditions from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. The patient received unspecified concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 15Feb2021 at 13:00 the patient experienced getting out of breath, three blood clots/clots were in my leg heart and lung, and cough. The events resulted in emergency room visit and the patient was hospitalized (from an unknown date) for the events getting out of breath, three blood clots/clots were in my leg heart and lung, and cough for 6 days. The clinical course is as follows: 2 or 3 weeks after the patient got the vaccine she started getting out of breath when she walked. Each day she got worse. Then the patient was taken to the hospital where they discovered the patient had three blood clots. The clots were in the patient's leg, heart and lung. The patient stated the Doctors do not understand where the clots came from. The patient was in the hospital 6 days. The patient stated they are still having breathing problem and still on oxygen as needed and they still cough at night. The patient asked if there have been any other reports of this happening to other people who got the vaccine as the patient never had blood clots before this. The patient underwent lab tests and procedures which included COVID test (nasal swab): negative on 15Mar2021. Therapeutic measures were taken as a result of getting out of breath, three blood clots/clots were in my leg heart and lung, and cough and included blood thinners and oxygen therapy and complete bed rest. The clinical outcome of the events getting out of breath, three blood clots/clots were in my leg heart and lung, and cough was not recovered. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.

Six days after the second dose of Pfizer I started experiencing shortness of breath so I went to the ER and took a chest x-ray and had fluid in my lungs. Doctors discovered I had Atrial Fibrillation. In January I had an Echo Cardiogram and none of the previous described diagnoses were present then. I was admitted; doctors attempted to shock my heart back into rhythm several times but were unsuccessful. Therefore, I was put on Eliquis (5mg) and a water pill to get rid of the fluid in my lungs (and swollen ankles). I was hospitalized for 9 days where I was evaluated through numerous tests. Eventually it was suggested that I undergo the Watchman's Procedure to get off blood thinners. Everything went well with that surgery on Thursday May 20th; complications arose after the surgery: heart rate and blood pressure spike, lungs started filling up with fluid. Ended up in ICU for four days. I still have a problem with my lungs despite having no history of lung problems and I am now dealing with AFIB. This all started 6 days after my second shot.

Patient admit to Hospital 5/23/21 for cough, weakness and SOB x 4 days. Pt had completed COVID19 vaccines earlier in the year and attended a family wedding 5/14/21 and developed respiratory symptoms within 3 to 4 days thereafter. Several family members now COVID19 positive, including patient (positive test approximately 5/18). Patient with history of COPD (on 2L 02 at home), and decision made to admit patient for close monitoring. Vaccination History: 1/23/21 Pfizer EL3249 2/13/21 Pfizer EL9264 Hospital Course: Patient admitted to COVID19 general unit, and started on IV dexamethasone (6mg IV daily) and remdesivir (200mg IV x 1, then 100mg IV daily). COVID19 test 5/24 was positive, and was to be sent to ODH for genotyping. Patient required 02 at 4L NC initially, then was able to tolerate 2L NC thereafter. Patient improved with less body aches and no SOB by 5/25. Patient continued to improve and was discharged home with HHC 5/28 with remdesivir course complete and home going med of dexamethasone 6mg daily x 5 more days.

lightheadedness; shortness of breath (sensation of sob); This is a Spontaneous report from a non-contactable other Healthcare Professional reporting for a patient. An 83-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration on an unspecified date (At the age of 83-years-old ) as First dose, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, 15 minutes after vaccination, the patient experienced lightheadedness and shortness of breath (sensation of sob). She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling Patient had differential diagnosis of Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns). Water and snacks treatment received. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Death 5/12/2021 Causes of death listed on death certificate: 1) Acute Myocardial Infarction 2) Acute Coronary Artery Thrombosis 3) COVID-19 Other: Acute Respiratory Failure

Loss of voice, difficulty swallowing, rapid muscle mass deterioration, eventual death on 5/21/2021 from acute respiratory failure, and slight pneumonia.

I am an 83 year old female who was thought to have Guillain-Barre ca. 40 years ago. I was paralyzed from the waist down, hospitalized, and had a very slow recovery. This paralysis caused clawed toes that were straightened surgically and affected my balance and walking (I use two hiking poles as aids for walking and balance.) Little was known at that time. I received the first Pfizer Covid shot on April 18, 2021. Two days after I had the Covid shot, the nerves in my left leg, below the knee, were sore when pressed and the affected muscles felt numb. This has persisted and at times different nerves in my lower leg are affected. Currently the muscles going down the back of my lower leg and around the ankle are affected. Three nights after the Covid shot, I had severe left kidney pains, became violently sick and the following morning went to my health facility emergency care department. I had no previous kidney problems or signs of a UTI. I had a CT scan of the kidney and was treated for a kidney infection and UTI with antibiotics. I have been to a kidney specialist and urologist with tests continuing. My breathing was erratic for a few days and I felt nauseous for 2 weeks. I have not had the second covid shot.

Labored breathing; chest pressure; fatigue; chest felt very tight; she is not planning to get her second vaccine; because has vertigo besides this; she can't swallow; Wheezing; got very sick; pains all over; headache; neck pain; arm pain; bone pain; This is a spontaneous report from a contactable consumer (patient). A 83-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: GWO196), via an unspecified route of administration in Arm Left on 24Jun2021 at 04:00 (83-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included bl high cholesterol; reported that her body makes cholesterol, it is not what she eats. It is 350 sometimes, 300 is high. Asthma, swollen, blood pressure, allergy with some soaps, adhesives they have to put one with cloth that does not have the same qualities as adhesive or otherwise she gets a rash, history of stents for heart attack, couple of arteries clogged but not showing any signs of causing problems, cancer. The patient had allergy with some medicines like clindamycin, Percocet, Percodan, penicillins. Concomitant medications included amlodipine (AMLODIPINE, dose: 5 mg, 1x/day) taken for blood pressure; atorvastatin (ATORVASTATIN, dose: 40 mg (she has been taking for years)) taken for blood cholesterol; furosemide (LASIX [FUROSEMIDE, dose: 20 mg (for three years. Not every day)]) taken for when her legs get swollen; salbutamol sulfate (VENTOLIN ACCUHALER) taken for asthma. It was reported that amlodipine was taken 3 or 5 years she has been on, but does not remember off hand, atorvastatin was taken maybe 8 years, it runs in her family everybody has it. She has been taking all her medications 50 years but not her cholesterol medication, for Lasix she is running like a chicken with her head cut off because everything that has happened to her. She takes 20, her daughter takes 40 mg not every day, for Ventolin when foggy outside she gets wheezy and when she is outside walking, she does one spray once and that is it. Years ago, she had bad asthma but not in the last 5 years except with weather. The patient previously took flu vaccine vii every year and experienced her arm hurt a little bit, coughing, chest hurt, did not have breathing thing, she got the flu, fainted. Reported that she was getting the flu vaccine every year, she takes it, and was okay the first time but her arm hurt a little bit and it never hurt. Two years ago, she took it and 2 weeks later felt sick like coughing and her chest hurt and she did not have breathing thing. Coughing and chest hurting led to her going to the emergency because she also fainted, so she called # and they took her to the hospital. She did tests and it was not her heart. They tested her for the flu and she said oh I already got my flu shot and they said well good thing you did. Caller confirms she got the flu after getting the flu shot. Reported that after experiencing labored breathing, chest pain, she called a cardiologist and went to the doctors and was admitted to the hospital for cardiac testing, and complains of labored breathing and fatigue. She wants this documented and has a history of stents in the past but hospital workup was negative. She had a heart attack 3 years ago and has stents in her heart. What happened when she called, she had cancer 5 years ago, when she called the oncologist and told him he said call cardiologist and she told her that she had the vaccine. She was taken by ambulance to the hospital and they did a bunch of tests and electrocardiogram and xrays and put her on monitor. After a few hours, they sent her to the cardiac floor where they gave her an injection, more blood tests, more of everything. The next day, nuclear testing of the heard and all of that stuff and sent her home and said it was not her heart and it was fine. She still had a couple of arteries clogged but not showing any signs of causing problems so they do not have to put a stent in. Caller confirms this was prior to receiving the vaccine because she has arteries clogged but only one with a stent and she still does not need a stent. No history of previous immunization with the Pfizer vaccine considered as suspect. No prior Vaccinations within 4 weeks. Reported that after vaccination they left her there for the 15 minutes and she had no reaction and came home and said my God, I should have done this a long time ago, because her arm was perfect and did not hurt and she had no symptoms till 2 o'clock in the morning. Reported that she is not planning to get her second vaccine. The second one she hears has worse and more side effects. She does not know what is going to happen if she only has one. She is supposed to have one 15Jul2021 in a couple days and right now she cannot take it if she is feeling this way because it is impossible and how should she do it if she is sick. Reported that Dr was afraid she was having a heart attack because she felt think someone was squeezing her chest and her breathing wasn't normal, so the hospital did all kinds of cardiac evaluation and they admitted her to the cardiac floor and continued to have all kinds of cardiac testing done, turns out her heart was okay, even though she has a stent in her heart and has 2 arteries that are clogged but they do not need to be fixed because there are not clogged to the point where it would cause her any problems, All the test showed that she did not have a heart attack. She has a lot of fatigue, if she walks from the bedroom to the kitchen, she really tires and feels like her breathing is labored, it's awful, and pains in the neck, even though before used to have a little pain in the neck, because has vertigo besides this but now has to be putting Ice packs constantly on the neck, waits and hour and then again and takes Motrin for the pain. Also the muscles, the doctor says the muscle in the chest, not in her heart and when she touches it hurts. Also having episodes where she can't swallow like she used to and had Asthma but kinda went away and now has started the past 2 days having Asthma, always has a pump with her because when it is foggy out she gets a little wheezing since yesterday, when she wakes up in the morning she hears the wheezing so will take a puff from the inhaler, so she would like this to be registered because she is 84 year old lady and has some issues that she never had other than when she had a heart attack, to which she had to change her medication. On 26Jun2021, the patient experienced labored breathing, chest pressure, fatigue, chest felt very tight, on an unspecified date, the patient experienced she is not planning to get her second vaccine, because has vertigo besides this, on 07Jul2021, the patient experienced wheezing, on 24Jun2021, the patient experienced got very sick, pains all over, headache, neck pain, arm pain, bone pain. It was reported that some term highlighted by the reporter as Labored breathing, chest pressure, fatigue. It was reported that it was not chest pain but it was pressure like somebody was squeezing her heart or had a rock on it and it weighed 100 pounds. It has gotten worse now that she is having wheezing in the morning. She had to use an inhaler for asthma yesterday. It has not gotten worse but it is the same. AE(s) require a visit to emergency Room and physician Office and hospitalized for one day. The patient was hospitalized for labored breathing, chest pressure and fatigue and chest felt very tight from 30Jun2021 to 01Jul2021. The patient underwent lab tests and procedures which included blood test resulted as unknown results, height resulted as 149.86 cm which she think shrunk and got fat, she used to be 4'11", electrocardiogram resulted as unknown results, nuclear testing of the heard resulted as it was fine, weight resulted as 100 lbs on 26Jun2021 which rock on it and it weighed 100 pounds, x-ray resulted as unknown results. Reported that all tests were negative but they put her in for her heart and no other reason to keep her because she did not need any kind of procedure done. Once they found it, she went home. Patient received treatment for events (labored breathing, chest pressure, fatigue, chest felt very tight, wheezing, pains all over, neck pain. The outcome of events Labored breathing, chest pressure, fatigue, chest felt very tight, Wheezing was not recovered, the outcome of events she is not planning to get her second vaccine, got very sick, pains all over, headache, neck pain, arm pain, bone pain, because has vertigo besides this and she can't swallow was unknown.

Pain in chest; Lightheadedness; Chills; Fever; Splitting headache; Fatigue; Nauseated; Eyes were watering; Pain in lymph nodes in neck when touched; Loss of appetite; Felt like heart was going to go through her head; Heart was racing; Felt like her throat was closing up a little bit; This is a spontaneous report from a contactable consumer (Patient). A 83-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:00 (age at vaccination: 83-yesr-old) as single dose for covid-19 immunization. (Vaccination facility: Clinic). Medical history included bursitis, arthritis, High blood pressure, High cholesterol all from an unknown date and unknown if ongoing, body aches many years at least from 10 years ago. Concomitant medication included ubidecarenone (COQ-10) taken for myalgia (started shortly after she started taking the cholesterol medication and she found out she was having body aches many years at least 10 years ago), acetylsalicylic acid (ASPIRIN CHILDREN) taken for cardiac disorder (started since long time ago probably 15 years or better), LISINOPRIL taken for blood pressure measurement (stated since many years), SIMVASTATIN taken for blood cholesterol increased (from same time as the lisinopril, at least 10 many years). Vaccine not Administered at Facility. It was reported that patient stated she and her husband received their second dose of the Covid shot clarified to be the Pfizer Covid 19 vaccine. She stated that she got almost every symptom on the list. Later that both she and her husband experienced fatigue. reported that she broke her hip a few years ago and that her husband told her that she did better after breaking hip than after receiving the Covid 19 vaccine. She reported that she does not usually experience any side effects after vaccinations stating that she normally sails right through the flu shot. She stated she just retired from a full time job in the first part of February, and if she had still been working she wouldnt have been able to go to work. Patient reported that within 12 hours of receiving the Covid-19 vaccine she was woke up in middle of night around 2 AM with her heart was racing she felt like she was going to have a heart attack, and reported that it felt like heart was going through the top of her head. She stated that she used a breathing method that she uses when she feels her blood pressure is increased to calm herself down and that she can usually bring herself down within a few seconds. She stated it could have been her heart or her blood pressure that she felt like she was speeding. She also reported that she was running a fever had chills pain and a splitting headache. She stated that within 48 hours the worst had passed. headache improved after the first night but that for a few days after she would get a shot up the back of her neck into her head. She reported that it was quickly resolve on its own. fatigue was worse after the second dose and they are both still experiencing fatigue. She was stated that she feels that the fatigue has improved but at the time of the call she stated that she felt like she could lay down and take a nap. She stated that the fatigue could also be related to her age. She is still having some lightheadedness if she stands up too quickly, she has to take a moment to balance herself before she proceeds, this was began after receiving the Covid 19 vaccine. She stated she was Felt like her throat was closing up a little bit, she did not feel that it was emergent or life threatening that she thought it was related to her swollen lymph nodes. she noticed pain around her breasts when she put her bra on mostly on the left side. She stated that she believed that it was lymph nodes in her chest that were causing the discomfort. She was unsure of when it began because she was down for 48 hours and stated that she noticed the pain around 05 Mar 2021. She reported that the pain gradually diminished. She stated that it didnt bother her, she was noticed it when getting dressed. She stated she was just slightly nauseated but that she didnt throw up or anything. She stated that her stomach felt a little queasy or upset, but that it wasn't anything serious. Caller stated that the nausea resolved a few days later around 06Mar2021 or 07Mar2021. Reported that the watering eyes have cleared up. She stated that it resolved quickly maybe a day or two after they began on 04 or 05Mar2021. She also reported had Pain in lymph nodes of neck she felt around her throat and felt like her lymph nodes were inflamed, they were painful to touch. She stated that the pain gradually diminished. Loss of appetite occurred in the same time frame as the nausea. She stated that she was hungry but her stomach just didnt feel like it had the room for food. She reported that the loss of appetite resolved a few days later around 06 or 07Mar2021. Received treatment with Tylenol she stated during the 48 hours after symptoms began she stayed in bed and slept. She reported that she was get up to get a drink or take Tylenol just a couple a day and was drank water. She reported that she drank lots of fluids. She stated that she was get up would take something and then go right back to sleep. Tylenol helped a little bit Tylenol doesn't do a whole lot but it's better than nothing. Adverse event not resulted in Physician Office visit or ER visit. The outcome for the event Fatigue and Lightheadedness was resolving, for events Loss of appetite, Eyes were watering, Nauseated outcome was resolved on Mar2021, for events Felt like heart was going to go through her head, Heart was racing outcome was reported as resolved on 03Mar2021 and for events Fever, Chills, Splitting headache, Felt like her throat was closing up a little bit outcome was resolved on 05Mar2021, and for remaining events outcome was resolved on unspecified date. Follow-up attempts are completed. No further information expected.

Pain in chest; Bursitis; High blood pressure; High cholesterol; stomach felt a little queasy or upset; Lightheadedness; Loss of appetite; Felt like her throat was closing up a little bit; Eyes were watering; Pain in lymph nodes in neck when touched; NAUSEATED; Fatigue; Felt like heart was going to go through her head; Heart was racing; fever; Chills; Splitting headache; This is a spontaneous report from a contactable consumer or other non-health care professional. An 83-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EM98089, Expiration date: Unknown), dose 2 via an unspecified route of administration in Arm Left on 02Mar2021 at 13:00 as dose 2, single for covid-19 immunisation. The patient medical history included bursitis, arthritis Verbatim: Arthritis, hypertension, ongoing blood cholesterol increased. The patient also received first dose on bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection) via an unspecified route of administration on 09Feb2021 as dose 1, singe for covid-19 immunisation. The patient concomitant medications included ubidecarenone (coq-10) taken for myalgia, start and stop date were not reported; acetylsalicylic acid (aspirin children) taken for an unspecified indication, start and stop date were not reported; lisinopril (lisinopril) taken for blood pressure measurement, start and stop date were not reported; simvastatin (simvastatin) taken for blood cholesterol increased, The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Caller reported that within 12 hours of receiving the Covid-19 vaccine, she woke up in middle of night around 2 AM with her heart racing, she felt like she was going to have a heart attack and reported that it felt like heart was going through the top of her head. She stated that she used a breathing method that she uses when she feels her blood pressure is increased to calm herself down and that she can usually bring herself down within a few seconds. Caller reported that it could have been her heart or her blood pressure, that she felt like she was speeding. Caller reported that she was running a fever, had chills, pain, and a splitting headache. She stated that within 48 hours the worst had passed. Caller stated that the headache improved after the first night, but that for a few days after she would get a shot up the back of her neck into her head. She reported that it would quickly resolve on its own and also that both she and her husband experienced fatigue after receiving the first dose of the Covid-19 vaccine, but that the fatigue was worse after the second dose and they are both still experiencing fatigue. Caller stated that she feels that the fatigue has improved, but at the time of the call she stated that she felt like she could lay down and take a nap. She stated that the fatigue could also be related to her age. she was still having some light-headedness if she stands up too quickly. She reported that she has to take a moment to balance herself before she proceeds. She stated that this began after receiving the Covid-19 vaccine. Felt like her throat was closing up a little bit: Caller reported that she did not feel that it was emergent or life threatening, that she thought it was related to her swollen lymph nodes. Caller reported that she noticed pain around her breasts when she put her bra on, mostly on the left side. She stated that she believed that it was lymph nodes in her chest that were causing the discomfort. Caller stated she is unsure of when it began because she was down for 48 hours and stated that she noticed the pain around 05Mar2021. She reported that the pain gradually diminished. She stated that it didn't bother her, that she just happened to notice it when getting dressed. she was just slightly nauseated but that she didn't throw up or anything. She stated that her stomach felt a little queasy or upset, but that it wasn't anything serious. Caller stated that the nausea resolved a few days later, around 06Mar2021 or 07Mar2021, went along with throat feeling like it was closing up. Caller reported that the watering eyes have cleared up. She stated that it resolved quickly, maybe a day or two after they began on 04 or 05Mar2021. she felt around her throat and felt like her lymph nodes were inflamed, they were painful to touch. She stated that the pain gradually diminished. Caller reported that the loss of appetite occurred in the same time frame as the nausea. She stated that she was hungry, but her stomach just didn't feel like it had the room for food. She reported that the loss of appetite resolved a few days later, around 06 or 07Mar2021. Caller reported that during the 48 hours after symptoms began, she stayed in bed and slept. She reported that she would get up to get a drink or take Tylenol, just a couple a day, and would drink water. She reported that she drank lots of fluids. She stated that she would get up, would take something, and then go right back to sleep. Tylenol helped a little bit, Tylenol did not do a whole lot, but it's better than nothing. Tylenol: UPC/lot/expiry not provided. Caller stated that she was not supposed to take ibuprofen, saying the reason was something to do with blood pressure or something. She reported that if the AEs she experienced had gotten severe, she would have called her doctor and had them check it out or at least asked advice. She stated that because symptoms began resolving after 48 hours, she thought it was ok. She reported that she is going to the doctor in May for a routine check-up, and they will inform her if anything has changed. The outcome of events was fatigue was resolving and outcome of other events Felt like heart was going to go through her head, fever, Chills, Splitting headache, Felt like her throat was closing up a little bit was resolved on 05Mar2021, Heart was racing on 03-MAR-2021. Outcome of events Loss of appetite, Lightheadedness, Eyes were watering, Pain in lymph nodes in neck when touched, High cholesterol, stomach felt a little queasy or upset on an unspecified date. Outcome of Bursitis, High blood pressure was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Patient presented to emergency department on 7/24/2021 with complaints of shortness of breath, weakness, fatigue, bloody stool. Also reports having chills and has a mild cough. Patient has COPD.

Pt developed heavy chest and SOB sensation with pain behind her left ear. All self resolved after approx 10 mins.

Systemic: Other- Patient mildly panicked and had some mild shortness of breath 15 minutes after injection of 2nd dose. Pt monitored for full 30 minutes after which symptoms quickly resolved. No epinephrine given. -Mild

Generalized weakness and body aches. Clinic stated that the pt was anxious and was "not feeling good". Pt states she feels SOB. O2 is 97% on RA. Pt does have bilateral edema in lower extremities. Pt does have a history of dementia. Clinic sent patient to the emergency room due to these symptoms.

Narrative: Patient with history advanced vascular dementia, hypertensive cerebrovascular disease and stroke, T2DM. Received her second dose of Pfizer COVID-19 vaccine at approximately 14:00 and was reported to have expired at home at 20:55. Dr. (Medical Director) spoke with patient's son/caregiver 2/4/21. Son reports that patient was in her usual health yesterday morning, deemed well enough by son to travel for vaccination. He reports she had no bothersome symptoms after either first or second vaccinations. Specifically denied rash, wheeze, and difficulty breathing. Son was with patient throughout the day. In the evening, when preparing for bed, he noted she became suddenly unresponsive in a similar fashion as she has done several times in past years. While in all previous such episodes she recovered within minutes, last evening she did not regain consciousness, experiences a brief period of labored breathing, and died. Patient's son called 911 and the patient's body was brought to the medical examiners. The medical examiner declined to proceed with autopsy. Patient's son is not interested in autopsy. Patient's son reports confidence that his mother's underlying hypertensive/diabetic cardiovascular disease is the natural cause of her death. Other Relevant Hx: Symptoms: & Death Treatment:

Pt felt a chest and stomach burning about 10 minutes, throat tightness, and tingling around her mouth

Patient was brought in by ambulance on 01/28/2021 with complaints of fever, chills, myalgias, shakiness, and severe hypotension. Patient was treated for severe sepsis and acute kidney injury. Patient was given fluid resuscitation, but unresponsive to treatment; NE+ vasopressin, hydrocortisone IV, along with empiric antibiotic regimen were initiated. Patient later on developed pulmonary edema, Non-ST elevation MI with no chest pain and new onset of cardiomyopathy with EF 40-45% and clean coronary arteries shown on cardiac catheterization. Physician suspected cytokine release syndrome related to the COVID vaccine and congestive heart failure. Naranjo scale score of 2 indicates possible ADR. MD indicated vaccine reaction unlikely.

Patient received 1st dose of vaccine on 2/6/21. That afternoon, developed malaise and fever/chills over the next few days. On the evening on 2/9/21, began to have left-sided chest pain (severe, pleuritic, radiating to left arm) leading her to seek medical care. Was determined to have viral pericarditis and admitted to the hospital for several days

A complaint of tightness in throat 5 mins after admin of vaccine, drove care to wait 30 min wait area, after parking car called for this nurse, then reported "feeling tightness in throat ", VS taken, 02SAt 89% sitting up, instructed to taken deep breaths and reposition self, VS repeated 02Sat 96% after appox 20 mins. Speech clear and LOC appropriate and oriented to time, person and place, skin pink warm to touch, appeared relaxed and calm good interaction during assessment. Stated, " feeling OK" able to speak and swallow without difficulty, appeared in good humor with staff and companion in car. Was stable and drove car away from the event.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe

The patient received her covid 19 Pfizer vaccine on 2/25./21. Later that day her daughter went to her home to check on her. Upon arriving, she found that her mother's skin was red and itchy, her face was swollen, and she was having trouble breathing. The patient was taken to the hospital thereafter. Her primary care physician is aware and does not want the patient receiving the second dose.

CHEST TIGHTNESS, CHEST PAIN, DYSPNEA, MYALGIA BEGINNING 48 HRS AFTER VACCINE WAS GIVEN, LASTING > 48 HOURS. GRADUAL DISSIPATION IS NOTED.

This is an 84 year old patient who presented for her initial dose of the Pfizer/BionTech COVID-19 vaccine. About 10-15 minutes after receiving the dose, she experienced a burning sensation in her upper mid-chest, felt dizzy, felt nauseous. She also said that she initially had dyspnea, but denied cough or wheezing (she denies a prior history of chronic respiratory disease, such as asthma). She said that her throat began to feel tight, and she was administered epinephrine at the immunization point of distribution (at the gym). She was then transferred via EMS to the ER for further evaluation. She denied experiencing cutaneous symptoms. She denied vomiting, diarrhea, syncope. She states that she has an allergy to sulfa drugs (she develops hives) and has an allergy to penicillin (she states that she passed out after receiving a penicillin shot as a teenager, but did not have any other systemic symptoms).

Patient reports increased SOB s/p 2nd dose of vaccination. Symptoms began 1 week following 2nd dose. Continues to use home O2 therapy for improvement of symptoms. Advised to follow-up with PCP and Pulmonologist.

SHORTNESS OF BREATH Bradycardia Hypothermia Cardiomyopathy Elevated troponin Acute renal failure (ARF) Death

3/13/21 Ferrell ER to admission hpi: 84 y.o. female presented to the emergency room with complaints of back pain, nausea, and abdominal pain. Patient approximately 1 week ago was bending over to pick something up and fell to the floor landing on her coccyx, and has had increased low back pain since that time. Patient does have a history of congestive heart failure and atrial fibrillation. Patient states that she had noticed increasing lower extremity edema and mild shortness of breath with exertion. The patient states that her back pain escalated and she was unable to stand or walk on her own. Patient was then brought to the ER for further evaluation per EMS. The patient did have a CT of the abdomen and pelvis which showed no definite acute intra-abdominal/pelvic abnormality, and mild acute during L2 superior endplate compression fracture with approximately 4 mm of displacement into the spinal canal. Patient also had a CT of the lumbar spine without contrast which showed acute appearing mild L2 superior endplate compression fracture with approximately 2 mm of displacement to the spinal canal, and multilevel degenerative disc disease. This morning upon entering the room the patient was standing with assistance of a walker and hospital staff. Patient tolerated fair. Patient does complain of severe pain with standing and movement. Patient does have 3+ pitting edema to bilateral lower extremities. Denies numbness or tingling to lower extremities. Bilateral lower extremity pulses are 1+ 1+, with CMS being less than 3 sec and skin is pink warm and dry. Patient's EKG in the emergency room did show atrial fibrillation with RVR with a rate of 137. Patient was given Cardizem IV in the emergency room, and then was started on Cardizem CD 100 80 mg p.o. daily. Patient's rate is controlled at between 92 and 96 beats per minute and continues to show atrial fibrillation on the telemetry. No shortness of breath is noted at this time. Patient did also have lab work drawn in the emergency room CBC: White count is 9.4, hemoglobin 14.4, hematocrit was 43.7, with a platelet count of 261. Patient's CMP showed a BUN of 21, creatinine 1.2, potassium was normal at 4.6, and her GFR was noted at 41. Patient also had a BMP drawn which was noted at 322. Patient also had a urinalysis performed which shows negative for leukocytes, nitrate negative. Patient was admitted to medical inpatient as it is deemed that she will need longer than a 2 midnight stay for cardiac monitoring and will work with physical therapy and occupational therapy for gait training and strengthening with relation to the compression fracture of her L2 fracture, and pain control.

SHORTNESS OF BREATH PT bibm c/o sob, per medics new afib rvr with elevated respirations and low et02 and bp. patient had a recent covid vaccine last week. Chest x-ray is normal but her BNP is elevated which may be related to her underlying ischemia

Patient had increasing shortness of breath resulting in hospitalization requiring high amounts of oxygen. Patient has new onset of pulmonary fibrosis diagnosed by CT of chest with contrast

3/27/2021- @3 AM resident with increase in SOB with unresponsive episodes. Pt states she has history of unresponsive episodes related to cardiac issues, declined hospitalization.

suffers from asthma but never had the symptoms she's had now; shortness of breath; hoarse/ hoarseness; audible wheezing; doesn't have the energy; This is a spontaneous report from a contactable nurse (patient). This 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 10:00 (Batch/Lot Number: EN6208) as 0.3 ml, single for COVID-19 immunization. Medical history included asthma from 2019 and ongoing, when she would sleep her oxygen would drop, and shrunk from 5 feet 5 1/4 inches to now 5 feet 2 inches. She never found out why her oxygen saturations dropped at night but she does not have sleep apnea. Her saturations would drop down to the 80s and she would still be sleeping. Concomitant medications included ongoing albuterol [salbutamol] taken for asthma and oxygen taken for "when she would sleep her oxygen would drop" from 2012 and ongoing. Patient previously took Anoro and Qvar in Aug2019. Patient received the first dose of BNT162B2 on 25Feb2021 (lot number: EN6206, NDC:59267-1000-01, Expiry date unknown) in the left arm. With the first vaccine she did not have any symptoms, she thought she got saline. Only symptoms she felt were when they told her to wait 15 minutes and she sat there and when she got up and she was driving and had her window down her nose felt like it was swelling. She lost her sense of smell due to an injury and she had an acute sense of smell of tobacco from the car next to her. That is the only symptom she had. The acute sense of smell was about 30 minutes after she got her injection, about 5-7 minutes after that. She left about 10:30 am and it happened around 10:35-10:37 am. The acute sense of smell was short lived, it happened for a minute or two. Several years ago she had shoulder surgery and had her great granddaughter and she was playing with her and her foot got caught in the coffee table and she fell and her nose got cut and lost her sense of smell. When asked for seriousness criteria, patient stated it was significant because she had not been able to smell since 2011 and she had the sensation of her nose swelling. She felt like that but she was driving and could not look at her nose. She didn't have the feeling 15 minutes after the vaccine, she had been driving for 5-7 minutes and had the feeling and it was exactly when she got in the car. It was significant because she was able to smell something. Patient had her second dose of the Pfizer Covid-19 vaccine on 18Mar2021 and had shortness of breath. She suffers from asthma but never had the symptoms she's had now. She did not seem to be getting better and the slightest movement, she's short of breath. She is taking the medicine that she normally takes but never had to take it this much. She was short of breath and not paying that much attention to it, when she goes out she wears a mask, since last year, and she went to put the trash out and had shortness of breath stepping out the back door. She was talking to a friend long distance and she told her she was so short of breath. To get out of bed and turn in bed she's more short of breath. The shortness of breath may have started before Friday 26Mar2021 but that's when she noticed it. She would have her mask on, park her car and go to the post office and when she would walk to her PO box, which is the first of the boxes, she was exhausted and not getting enough air and she noticed it. But then when she went outside to put the trash out, just a step outside she was short of breath, that's when she began to notice. She has never been this short of breath and her breathing and exchange of air has never been this bad. She thought she would maybe get her smell back and in all the years she's been diagnosed with asthma she's never had the wheezing and shortness of breath that she's had now. She's never heard herself wheeze. Monday night she was up at 3 am and got up to go to the bathroom and she was so short of breath. She had to take it at 3:30 am and that had never happened to her. She never had wheezing until the second vaccine. She doesn't need a stethoscope to hear the wheezing and that most people have asthma with wheezing but she did not. Patient was not taking the Qvar until after the second dose of the vaccine and was only using the albuterol before. She would take two puffs in her car and then put two masks before getting out. No additional vaccines administered on same date of the Pfizer suspect. No AE required a visit to emergency room or physician office. She was scheduled to see her primary doctor on 13Apr2021 but could not get in earlier and attempted to see her pulmonary doctor and the earliest she can is 07Apr2021 and she has that appointment. Patient was also very hoarse. From time to time medications like her inhaler for her asthma sometimes makes her hoarse. This time she has the hoarseness even when she doesn't take her inhaler. She has audible wheezing. She would not consider the shortness of breath life threatening but it is concerning because she is not able to do what she needs to do because she doesn't have the energy. Hoarseness is worsening because she is taking more of the medications she's normally taking and now she is taking the inhaler twice a day because she is more short of breath. The one inhaler she is using is Qvar. She has been taking the albuterol more also. Hoarseness is not life threatening, it is effective but it is not disabling. The more she talks, the more hoarse she gets. Relatedness of drug to reactions shortness of breath, very hoarse, by primary source reporter (Method of assessment: Global Introspection) was related. Outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Asthma aggravated and Shortness of breath cannot be excluded. Medical history of asthma may provide a plausible alternative explanation for the events. 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.

Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: 911 called to store. pt O2 stat was 90%. supplemental oxygen given by EMS. Pt transported to hospital by EMS. Pt BP was 184/102 and HR was 65 before EMS arrival.

symtptoms started evening of vaccine dose. Felt fine in am. found on floor by family brought to hosp by EMS, seizure disorder; didn't have the strength to get to bed due to fatigue, which is history. Also abd pain and diarrhea and myalgias. Mottled reticular rash diagnosis identified: Abdominal pain; Acidemia; Acute kidney injury; Lactic acidosis; Mottled skin; NSTEMI (non-ST elevated myocardial infarction); Right hip pain; Tachypnea; Weakness

COVID-19 pneumonia acute respiratory insufficiency with hypoxia Received 1 unit of convalescent plasma o Completed 5-day course of remdesivir o She received dexamethasone therapy in the hospital and has now been weaned off oxygen and her breathing is clear, dexamethasone will be discontinued on discharge as she has been weaned off oxygen o Rest and exercise oximetry completed prior to discharge and she did not qualify for oxygen

I was having palpitations; the feeling was in upper part of stomach; I had difficulty breathing; The initial case was missing the following minimum criteria: No Adverse effect. Upon receipt of follow-up information on 12Feb2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Consumer (patient) A 84-years-old female patient (weight reported as '140' only) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Jan2021 (at the age of 84) as single dose for covid-19 immunisation; denosumab (PROLIA), via an unspecified route of administration from 2019 and ongoing, cyclic, twice a year for osteoporosis. Medical history included osteoporosis. The patient's concomitant medications were not reported. The patient experienced palpitations, the feeling was in upper part of stomach (not in heart), difficulty breathing, all on 07Feb2021 at 20:00. No treatment received or hospital admission required. By bedtime she was able to fall asleep and awoke in the morning on 08Feb2021 and was fine. The events outcome was recovered on 08Feb2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained

About 15 to 20 min. (when Pharmacist was notified) after her shot, the patient reported in Spanish, through her daughter, numbness around the mouth. The Pharmacist had advised her to sit and wait 30 min. after the shot, due to her anaphylaxis history from multiple things. The Pharmacist monitored her and she continued to report itching on the forearm where she got the shot (not around the site) and slight shortness of breath. The patient never appeared to be in distress. As the symptoms continued, the Pharmacist decided, though an Epipen was ready to use, to call 911. Paramedics arrived within 5 to 7 min., questioned her, took her BP, Oxygen level and listened to her breathing (all were good). She said she was feeling better and said "no" when they asked her if she wanted to go to the hospital. The paramedics stayed with her about 10 minutes longer and she left with her family. She did not receive any Epipen or Benadryl (is allergic to it) but wanted to take a box of Claritin 10 mg with her (said it always helps). The paramedic told her Claritin will not help anaphylaxis (for future). The patient was advised to contact her physician because she probably would be at high risk for a second Covid vaccine.

having difficulty breathing because of her tongue; tongue started burning about 2 hours after receiving the vaccine; tongue as "burning up" and painful; body aches; arm pain; This is a spontaneous report from a contactable consumer (patient's child). An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on 28Jan2021 as first dose, single for an Covid-19 immunization (At the age of 84 years). The patient medical history and concomitant medications were not reported. On 28Jan2021 (yesterday), the patient received the first dose of the Pfizer COVID-19 vaccine, and noticed her tongue started burning about 2 hours after receiving the vaccine. On 28Jan2021, she was also experiencing body aches and arm pain. The patient described her tongue as "burning up" and painful and she was having difficulty breathing (start: 28Jan2021) because of her tongue. The reporter was taking her mother to the hospital now (29Jan2021). The outcome for all the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Shortness of breath; Joint pain; Feeling unwell; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (24Feb2021), this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer sponsored program via contactable consumer (Patient) and in response to Non HCP letter sent. A 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: unknown, Lot number and Expiration date: unknown), via an unspecified route of administration on 10Feb2021 at 01:45 on Arm left (at the age of 84-year-old) as 2ND DOSE, SINGLE DOSE (1 shot) for COVID-19 immunisation in Hospital. Vaccine wasn't administered at a Facility. No other products were taken together. There are predisposing factors. The patients medical history was not reported. Concomitant medications was none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: unknown, Lot number and Expiration date: unknown), via an unspecified route of administration on 20Jan2021 (at the age of 84-year-old) as 1ST DOSE, SINGLE DOSE for for COVID-19 immunisation. Patient had her 1st shot of the vaccine yesterday (20Jan2021). On the 03Feb2021, she is scheduled to have surgery on her head patient is aware that they will put a shot in it. On 11Feb2021 at 08:00, the patient experienced shortness of breath, Joint pain and feeling unwell. No admission to hospital was involved. No treatment received was received. Patient was feeling fine now. No visit to emergency room and Physician Office. No culture was performed. Outcome of the events was recovered on an unknown date in 2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

Patient presented to the ED and was subsequently hospitalized for Acute respiratory failure with hypoxia within 6 weeks of receiving COVID vaccination.

Patient presented to the ED and was subsequently hospitalized twice within 6 weeks of receiving COVID vaccination. First time was 04/06/2021 for shortness of breath/ COPD exacerbation. The second time was 04/17/2021 for Closed fracture of proximal end of left humerus.

I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 5/15/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/8 and Dose 2 on 3/1). The patient later died on 5/28/21. Cause of Death is listed as ?Acute hypoxemic respiratory failure Pneumonia COVID-19?. Pre-existing conditions listed as: CARDIOVASCULAR DISEASE, DIABETES MELLITUS, CHRONIC LUNG DISEASE (ASTHMA/EMPHYSEMA/COPD)

Around 4/19/21 pt started experiencing shortness of breath that increased to the point of gasping for breath on 4/25/21. Her daughter (me!) visited and immediately called her pulmonologist who requested she immediately go to the hospital. The ER said she had an enlarged heart, and was checked in to the cardiac unit. Tests showed she had acute systolic and diastolic heart failure. She was first put on diuretics while further tests were done, and Tikosyn was later added to her list of regular medications. Within a week she was able to go home. She was on oxygen prior to this event from the pulmonary fibrosis, and was able to return to her prior settings on her oxygen concentrator within five days, but her ongoing discomfort has stayed at a heightened level, and her level of activity has not returned to her normal. Please note: she is an 84 year old with pulmonary fibrosis. It is not possible for me as her daughter (not a medical professional) to know if the original diagnosis of heart inflammation was related to her vaccination, but she had been relatively stable for more than six months prior to this hospitalization event and the onset of this sequence of events was identified by the doctors as being of unknown origin at that time.

ischemic stroke; infection; progressive weakness; poor appetite; hardly being able to walk; dehydrated; mild elevated liver enzymes and WBC count; mild elevated liver enzymes and WBC count; SOB; possible lung infection; some lesions on her liver; a small mass in her lung,which they said were suspicious for cancer; a small mass in her lung,which they said were suspicious for cancer; This is a spontaneous report from a contactable nurse. A non-pregnant 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 13Apr2021 (at the age of 84-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension (HTN), hyperlipidaemia (HLD), type II diabetes mellitus (DM2). Concomitant medications included regular prescribed medications for HTN, HLD, DM2 (drugs unspecified). No other vaccines prior to four weeks. Known allergies were unknown. No COVID prior to vaccination. Covid test post vaccination in May2021 was negative. The patient had no acute issues prior to her 1st COVID vaccine. In Apr2021, the started experiencing progressive weakness and poor appetite to the point of hardly being able to walk. The patient saw her primary doctor who ran some blood work and noticed she was dehydrated with mild elevated liver enzymes and WBC count. The patient was admitted to the hospital (for 21 days) for IV fluids and was on oral antibiotics. The patient started having some SOB and scans done indicated possible lung infection. The patient was switched to IV meropenem which did not help. The doctors also noted some lesions on her liver and a small mass in her lung (no biopsy was done cause she declined) which they said were suspicious for cancer. The patient then suffered a large ischemic stroke and she passed about a week later. The patient was feeling well before her vaccine and everything started to go downhill after her vaccine. AEs result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent covid test: negative in May2021. The outcome of events weakness, decreased appetite, unable to walk, dehydration, elevated liver enzymes, white blood cell count increased, short of breath, lung infection, hepatic lesion, lung mass, and lung cancer was unknown. The patient died on 27May2021 due to ischemic stroke and infection. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported suspicion on malignancy and BNT162B2 use is unrelated while the causal relationship between the remaining events and the use of BNT162B2 cannot be fully excluded. There is limited information available which precludes a more meaningful assessment. However, the underlying conditions and the age of the patient maybe risk factors. The impact of this report on the benefit/risk profile of the Pfizer drug 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: ischemic stroke; infection

cough, difficulty breathing, productive cough, 02 requirement, weakness resulting in hospitalization and death. received treatment : Azithromycin and Decadron 02/09/2021-02/19/2020

Phone visito Visit History for 3/12/2021 Problem List* Health Maintenance* Results/Data* Review Flowsheets* History of Present Illness HPI: 84 yo female pmh: DJD right hip, CAD and chronic anticoagulation was contacted via telephone: states she received her covid 19 vaccine 3 days ago: now having dry (non productive cough)-denied any fever/chills or loss of smell/taste. o Visit History for 3/12/2021 Problem List* Health Maintenance* Results/Data* Review Flowsheets* History of Present Illness HPI: 84 yo female pmh: DJD right hip, CAD and chronic anticoagulation was contacted via telephone: states she received her covid 19 vaccine 3 days ago: now having dry (non productive cough)-denied any fever/chills or loss Issues Addressed/ Plan Diagnosis Plan 1. Viral upper respiratory tract infection (s/p covid 19 vaccine) predniSONE 20 MG Oral tablet albuterol (PROVENTIL HFA) 90 mcg/actuation Inhl inhaler (afebrile) Counseled on supportive measures Has declined covid 19 test Informed: if conditions worsens: present to ED (immediatetly) 3/25 pt's son in the room, updated and answered all questions at this time. 4/2 Pt's husband also inpatient and covid+. Spoke with daughter today and updated r/t quarantine. 2. Nursing Education/Concerns: Care team met with family (husband, son and daughter) on 3/18/21 to discuss care goals/plan of care moving forward. Pt's code status officially updated to DNR only with trial intubation. 3/18/2021 spoke updated pts daughter on phone at 1031. Report given to SNF- they were made aware that she needs the second pfizer vaccine 3. Interdisciplinary involvement Social Work/Case Management: From home with spouse. STR- Referral out. STR reviewing. Will not take patient before her 10 day exposure quarantine is over. 4/9. STR- Bed offer for tomorrow pending insurance auth and negative COVID. sent for auth. Patient aware. Son updated. COVID exposure - exposure to covid positive visitor on 3/26 and 3/29 - discussed with infection control. Will test on 3/31 and if negative will test again on 4/7 (day 9 of quarantine) unless symptoms develop in interm. Acute hypoxic respiratory failure secondary to acute on chronic systolic LV failure requiring prolonged ventilation and SNF placement after discharge. Encephalopathy, dysphagia, anemia, tachy, AKI

Sore throat; shortness of breath after walking short distance in home; Headache; Tiredness/ fatigued; Chills; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. An 84-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm on 05Mar2021 at 11:45 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included arthritis and had abatacept (ORENCIA) infusion monthly. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included alendronate sodium (FOSAMAX) and levothyroxine sodium (SYNTHROID) for unknown indications from unknown dates. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Mar2021, the patient experienced headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test on 23Mar2021 which included nasal swab and the test result was negative. The patient did not receive any treatment for the events headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home. The clinical outcomes of the events headache, sore throat, tiredness, fatigued, chills, diarrhea and shortness of breath after walking short distance in home were not recovered at the time of the report. No follow-up attempts are needed. No further information is expected.

Patient diagnosed with COVID 11/2020. little to no symptoms reported at that time except fatigue. Vaccinated 2/1/21 and 2/20/21. Admitted to HCF 5/30/21 with SOB. COVID + on 5/30/21. Treated with steroids and Remdesivir x 2 days DIscharged 6/2/21. Admitted to our facility 6/7/21 through 6/11/21 with possible COVID PNA. Thought could also be a CHF exacerbation.

Back aches; Chills; Couldn't breathe; Couldn't walk; pain; This is a spontaneous report from a contactable consumer (patient). A 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 20Feb2021 16:30 at 84-years-old (Batch/Lot Number: EL9264) as dose 2, single for COVID-19 immunization. Medical history included ongoing Thyroid issue, ongoing High blood pressure, Lung carcinoma cell type unspecified stage I (Lung cancer stage I, She hasn't had treatment for over a year. She had radiation.) Concomitant medications included levothyroxine taken for Thyroid issue from an unspecified start date and ongoing; losartan taken for High blood pressure from an unspecified start date and ongoing; aspirin [acetylsalicylic acid] taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9265), on right arm on 30Jan2021 at 84-years-old for COVID-19 Immunization. Patient had both Pfizer Covid Shots. She had side effects and had to be rushed to the hospital. They are sending her a bill, and she felt that she should not have to pay the hospital bill. Her insurance paid so much and the bill is for $250 that she doesn't have. It is for the ambulance. The vaccine was for Covid. She had the first dose on 30Jan2021 and the second on 20Feb2021. 2 days after the second one she had to be rushed to the hospital. She was getting chills, back aches, and all kinds of complications. She couldn't even move, and she called an ambulance. Her insurance left her with a $250 bill. She called the ambulance to say it is due to the Covid shot. Each time she called she waited over an hour. Yesterday she waited over an hour and a half. She is a little disgusted. Now she got a bill from the hospital, and she figured it was related to the Covid shot. She thinks they gave her a shot at the hospital. It was quite an experience. After she was admitted to the hospital for a couple hours that Saturday or Sunday so she thinks she was in the hospital on 21Feb2021, they gave her a shot and she started seeing things. It was an experience she doesn't want to go through again. She has no idea what the shot was, she thinks it was for the pain. They sent her home and gave her pills to take for the pain. She doesn't want to take too many pills for pain. The pills are Hydrocodone Acetaminophen, she takes one half to 1 tablet as needed for pain for up to 3 days. They are in an amber colored pharmacy bottle. It says OTY6. She couldn't walk 2 days after she had the second shot (22Feb2021). Back aches: She more of less ignored it. She took Tylenol and that didn't help. That Sunday she more or less started aching and couldn't breathe. She told her husband she had to get out of there. She just took regular Tylenol, expiration date: Nov2023. She does not see a lot number. Each one is 500mg. She has arthritis too. It is an over the counter medication. Couldn't breathe 2 days after she had the second shot. As a matter of fact, they had to lift her off of the bed. It was on and off for a couple of hours. She can't remember if she had any tests done. Adverse Event Chills, couldn't breathe, couldn't walk, and back aches time of onset (24-hour clock) was about 13:00 or 14:00. She did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She asked the doctor before taking the vaccine, and he said it wouldn't affect her at all. On the paper it specifies if she has any side effect to call the ambulance which she did. She cannot get them on the phone and waited over an hour. The outcome of the events was unknown. No follow-up attempts are possible. No further information expected.

Patient did not display any obvious signs or symptoms; the vaccination was administered at approximately 10:00 AM and the patient continued throughout her day without any complaints or signs of adverse reaction. Patient was helped to bed by the nursing assistant estimated at around 9:00 PM. The facility received notification from the lab around 11:00 PM that the patient's COVID-19 specimen collection from Sunday, 1/3/21, detected COVID-19. When the nursing staff went to the room to check on the resident and prepare her to move to a COVID-19 care area the patient was found unresponsive, no movement, no chest rises, noted regurgitated small amount of food to mouth left side, lying on left side. Pupils non reactive.

s/p vaccine-15-20 mins patient was having shortness of breath- gargling- unresponsive for 1 min. no cpr done. no epi given, regained response in 1 mins- had vomitting after wards. vitals normal and WNL

1252 Resident rang with complaints of chest pain and shortness of breath. BP 126/70, Temp 97.5, pulse 72, resp. 20, O2 sats on room air 90%. While awaiting transport complained of increasing shortness of breath. Resident transported to Community Hospital via Ambulance with 3L O2 . Resident placed on ventilator and transported to Medical Center

Tingling, numbness of lips, sensation of swelling in left side of throat without difficulty swallowing,, elevated BP, no shortness of breath, O2, P wnl. Benadryl 25 mg PO given and tolerated, flushing of face and still sensation of lt throat swelling, called EMS to transport to ED

Pt reports difficulty breathing that lasted apprx 2hrs. Pt did not reports the adverse event until the day after the AE occurred.

DAY 1 POST VACCINE PT HAD MODERATE-SEVERE SHORTNESS OF BREATH THAT WORSENED AROUND 1400. PT WAS BROUGHT TO THE EMERGENCY ROOM BY HER DAUGHTER.

1st Dose vaccine 1/29/21; Admitted to Hospital from ED 2/1/21-2/4/21 Dx PNA, d/c'd home. ; 2nd dose vaccine 2/19/21; seen in ED 2/22/21 for SOA, congestion, N/V, and Left flank pain x 3 days; admitted to hospital from ED 2/22/21 Dx: 1. Epigastric pain R10.13 789.06 2. Elevated brain natriuretic peptide (BNP) level R79.89 790.99 3. Dyspnea, unspecified type R06.00 786.09 4. Abnormal CT of the abdomen R93.5 793.6 5. Hypomagnesemia E83.42 275.2 6. Hypokalemia E87.6 276.8 Currently still admitted to hospital at time of this report.

1351: Complaint of nausea, diarrhea and not feeling well. Patient vomited yellowish phlegm. Patient denied dizziness, shortness of breath, pain and difficulty breathing. Patient alert and oriented x 3. Vitals T 97.2, O2 96%, P 86, BP 160/78, R 22. 1420: Vitals T 98.6, O2 97%, P 80, BP 120/62, R 20. Patient discharged from clinic.

1st vaccine on 2/18. Developed rash bilateral lower extremities. Underwent work-up for suspected vasculitis. Had lower extremity pain limiting ambulation and contributing to fall. Required hospital admission on 3/1 for ongoing work-up and treatment of vasculitis. Also found to have right Achilles tendon rupture. Discharged to skilled nursing facility on 3/6. 2nd vaccine on 3/11. Presented to ER on 3/13 with dyspnea and acute hypoxic respiratory failure due to diffuse alveolar hemorrhage/pulmonary edema requiring intubation on 3/17. Extubated 3/21 and transitioned to hospice care.

Approx. 02/04/2021 Pfizer Vaccine dose # 1 Started feeling cold all the time soon after which continues. Not feeling well in general which still continues. Very high fever and skin on face turned dark and red on left cheek like sunburned and dried up and then skin started flaking off. Heart rate remained normal which is in upper 50?s and 60?s. 02/25/2021 Pfizer Vaccine dose # 2 02/26/2021 57 BPM Heart Rate BP 155/69 03/01/2021 65 BPM Heart Rate BP 146/70 03/03/2021 59 BPM Heart Rate BP 155/67 03/04/2021 59 BPM Heart Rate BP 151/77 03/06/2021 59 BPM Heart Rate BP 145/68 03/10/2021 54 BPM Heart Rate BP 174/77 03/11/2021 80 BPM Heart Rate BP 151/79 03/12/2021 104 BPM Heart Rate BP 146/102 108 BPM Heart Rate BP 152/118 03/13/2021 114 BPM Heart Rate BP 125/72 Trouble breathing 03/14/2021 131 BPM Heart Rate BP 113/82 03/15/2021 129 BPM Heart Rate BP 155/111 03/26/2021 - 03/27/2021 can?t catch her breath and nearly lost consciousness several times Still feeling cold all the time and still not feeling well in general. Heart rate remains dangerously high and in atrial fibrillation

Due to history of allergic reactions, patient waited a full 30 minutes after receiving vaccine. However, shortly after getting in her car she experienced a feeling that her throat and tongue were swelling. Epinephrine administered and patient transported by EMS to hospital in area. patient states she left hospital at 5 pm on 3/26/21.

The day after receiving the second dose, pt became so weak that she couldn?t get out of bed. Also complained of chest pain (has CAD with angina).

Blood clots in leg and both lungs; shortness of breath. Shortness of breath for 1 week before seeking medical attention on March 7th. Admitted to hospital through emergency room on March 8th. Hospitalized from March 8-14. Put on Coumadin. Sent home with supplemental oxygen.

presented to Emergency room with complaints of approximately 5 days of progressively worsening shortness of breath with a dry nonproductive cough, increased weakness, and wheezing. Symptoms not controlled with increased use of rescue inhaler albuterol. Patient's daughter reached out and spoke with patient's pulmonologist Dr. today who ordered oral steroids however patient reports she had not started taking them yet. Patient was initiated on 15 L non-rebreather and received 2 duo nebs EN route to the hospital. It was reported she did have some intermittent chest tightness although on my review, she denied this. Upon arrival to the emergency room, patient was initiated on BiPAP and receive 40 mg of IV Lasix at 125 mg of IV Solu-Medrol. Patient expired 4/19/2021

chills; Fatigue; Some shortness of breath; Very slight headache; slight nausea; This is a spontaneous report received from a contactable consumer. This 85-year-old female consumer (patient) reported in response to Non-HCP letter sent in cross reference case. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot: EN6203, Expiration date not reported) via intramuscular route on upper Left arm on 24Feb2021 at 07:15 A.M single dose for COVID-19 immunisation. Patients medical history included Pain, swelling in left wrist from 15Nov2020 (ongoing, doctor suggested wrist brace and ibuprofen when needed) and on 15Feb2021, the patient had Pain still in wrist (ongoing, was given injection of 40mg, Kenalog eased pain immediate). Patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot: EL9264) via intramuscular route on upper Left arm on 03Feb2021 at 09:40 A.M as single dose for Covid-19 immunization and experienced pain in wrist. The patient's concomitant medications were not reported. Patient experienced in reaction to vaccine was chills, fatigue, some shortness of breath, very slight headache, slight nausea on unspecified date. Outcome of event was reported was reported as unknown. Follow-up (15Mar2021): The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (15Mar2021), this case now contains all required information to be considered valid.

My mother Received vaccine on 3/18/21. Approximately the week of 4/4/21 she started to experience shortness of breath and got progressively worse. On 4/9/2021 she was admitted to hospital and diagnosed with extensive clot burden within the interlobal pulmonary arteries bilaterally as well as upper lobar branches. Venous Doppler was a performed on 4/10/21 blood clots found in both lower legs Please note that I attempted several times to report this to Pfizer, I was disconnected once and was on hold for over hour with the same automated message replaying that there were 6 callers ahead of me. There was no option to leave a message for a return call to share what I feel is important safety information.

After second dose: Symptoms began from March 9 - March 13 with a few day pause, then continued ongoing; Little appetite, lethargy, no energy, in bed sleeping 18 plus hours out of a 24 hour period, continued until the morning of March 13, unremarkable symptoms from March 14 thru March 22, March 23 in home nurse recommended she see a cardiologist, March 24th rushed to the hospital short of breath with irregular heartbeat; released from hospital 24 hours later -could not determine cause; 1.5 days later second visit to emergency room with the same symptoms; release from hospital 2 days laters; saw cardiologist, symptoms have persisted and progressed, currently only able to take 1/2 to 1/4 short breathes; about 15 minuets per 24 hour period will full breath capacity; 3+ pillow orthopnea: sitting up at 45 angle in order to sleep, any lower angle cannot breathe; symptoms ongoing and worsening, cause unknown

S/p pfizer vaccine 4/9/21. S/p fall. She presented last wk to the hospital in cardiogenic shock, anemia, acute RLE DVTs, AKI, and rib fractures. She was found to have a n intramuscular hematoma along her posterior right thigh and with an acute DVT in her leg - see imaging reports below. Her INR was in the 7 range. She was also found to be in cardiogenic shock as mentioned above, requiring pressors. Pressors were eventually weaned off. S/p PRBCs. Imaging studies were obtained. Findings are listed below. Her AKI resolved by day of discharge. Since hospital discharge: The swelling is improving along her right leg. She is not checking her weight on a daily basis. She has access to a scale. She needs a refill on iron and Fosamax. No bleeding. On day of discharge, her hemoglobin was 8.8. Her MCV was elevated at 100. Her platelet count was 132. Her INR was 1.4. Her calcium is mildly low at 8.3. Her coumadin is on hold at this time. 106/56 was her BP today. She's been resting well. She's doing some house chores. She has yet to schedule a follow-up visit with for an INR check and in office checkup apt since hospital discharge. 4/23/21 RLE CT: Postop changes from ACDF for right femoral neck fracture again noted with good alignment. Early healing process of the fracture noted. No acute osseous fracture or hardware fracture. Extensive muscular and subcutaneous edema in right thigh. Two elongated intramuscular hematomas also noted at the medial posterior right thigh as above. 4/23/21 CXR: Patchy bibasilar pleural parenchymal opacities and enlarged cardiac silhouette without interval change. Multiple thoracic compression deformities better characterize on recent CT. Postoperative changes as discussed. Stable hiatal hernia. 4/23/21 RUQ Ultrasound: Mild gallbladder prominence, nonspecific. Findings similar to reference CT. No gallbladder wall thickening. Negative sonographic Murphy sign. Trace ascites. Partially evaluated right pleural effusion. Increased renal echogenicity. Correlate for medical renal disease. -1.1 cm right renal cyst. 4/22/21 PVL Study: Acute non-occlusive deep vein thrombosis in the mid and distal femoral vein within the right lower extremity. Acute non-occlusive deep vein thrombosis in the distal femoral vein within the left lower extremity. 4/21/21 Chest/Abdomen/Pelvis CT: Age-indeterminate T1, T3, T8, and T9 compression deformities. Subacute or chronic right posterior 12th, 11th, and 10th rib fractures. Intramuscular hematoma in the posterior right thigh, partially visualized. Subcutaneous contusion in the right posterior hip region. Small volume of free fluid which appears minimally complex. No convincing solid organ injury, but assessment is limited without administration of intravenous contrast. Mild biliary dilatation of uncertain etiology. Possible 1.8 cm peripherally calcified splenic artery aneurysm. Nonspecific bilateral perinephric stranding. Trace pleural effusions. Moderate sliding-type hiatal hernia. Additional incidentals as above. 4/21/21 C Spine CT: Age-indeterminate T1 compression fracture, new from March 2019. No other acute fracture or subluxation

Pneumonia due to COVID-19 virus Chronic respiratory failure with hypoxia (CMS/HCC) Shortness of breath remdesivir

Patient departed from vaccination clinic in no distress with no changes. Presented to ER with left sided facial droop which started on her drive home. Per ER note, patient did have aphasia and shortness of breath. Patient had quick change of respiratory sounds with suspected flash pulmonary edema. Noted to also have facial swelling. Anaphylaxis suspected. Patient intubated and admitted to ICU with guarded condition.

Client began having shortness of breath on 5/19. She was admitted to the ER on 5/21 at Hospital for further evaluation and requiring oxygen.

Hospitalized 5/30-6/10 for altered mental status following recent bacterial sepsis and atrial flutter, discharged to hospice, died 6/16. Primary cause of death acute respiratory failure, underlying cause COVID-19 pneumonia

urinary tract infection; sore arm; limited her ability to do things; angiogram showed mild blockage; progressively been getting weaker/weakness; bones periodically get icy cold; had heavy breathing which was difficult to control even with her focusing on her breathing; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 85-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6201; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Deltoid Left on 17Feb2021 at 03:00 as dose 2, single for COVID-19 immunisation. Medical history included atrial fibrillation. The patient's concomitant medications were not reported. The patient previously took BNT162B2 for covid-19 immunisation and experienced asthenia on 30Jan2021. Relevant medical history and concurrent conditions included a fib. The patient has allergy to iodine. The patient did not receive prior vaccinations within 4 weeks. The patient did not receive any prior vaccinations within 4 weeks of receiving covid-19 vaccine. The patient has been keeping a daily journal for over 20 years and she noticed a trend of her symptoms after the vaccines. On 29Mar2021, the patient experienced progressively been getting weaker/weakness, a feeling from the top of her head to her knees. In Mar2021, the patient experienced bones periodically get icy cold. On an unknown date, had heavy breathing which was difficult to control even with her focusing on her breathing; on an unspecified date, the patient experienced sore arm, urinary tract infection, limited her ability to do things and on 22Mar2021, the patient experienced angiogram showed mild blockage, so it does not require surgery. The patient knows there have been reports of body aches then you could say sensations numbness, tingling, etcetera. The patient wakes up and is good for about an hour at most and then she gets weakness. The patient went by ambulance to the emergency room on 1Mar2021, due to the weakness and was out on same day. The patient underwent lab test which included, COVID-19 virus test which was negative on 01Mar2021. On 22Mar2021 Angiogram showed mild blockage. On an unknown date, the white blood cell count was normal. Therapeutic measures were taken with a bag of Rocephin. The patient was on a recording monitor and it sends reports to her cardiologist every night and it has not noted an event in over 90 days. The clinical outcome of the events progressively been getting weaker/weakness was not recovered; bones periodically get icy cold, sore arm, angiogram showed mild blockage, had heavy breathing which was difficult to control even with her focusing on her breathing, limited her ability to do things urinary tract infection was unknown. No follow-up attempts needed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021633718 similar report from same reporter

Patient reported tightness in throat, lightheadedness, and cough after the 15 minute observation period. Patient was given Benadryl and symptoms improved in 15-20 minutes.

Tenant developed nausea/vomiting in the middle of the night after vaccination. The next day she continued with GI upset, fever, and body aches. Toward the afternoon with Tylenol she appeared to be feeling better. At around 6pm she had sudden onset shortness of breath and respiratory distress. Nebulizer was given without improvement, O2 sats were in the 70's and 80's. Tenant was transported to the hospital via ambulance

The patient had a her second covid-19 pfizer vaccine in the morning and two hrs later while going to hemodialysis developed trouble breathing and lightheadedness. She taken to the Emergency room. The Attending that saw the patient report this to us that she had stridor, wheezing. She was treated with H2 blocker, albuterol nebulizer, and methylprednisone, no epinephrine.

24 hours post event patient had vomiting and fevers. She was unable to walk to the ambulance and had to carried. Patient was admitted to hopsital and diagnosed with pneumonia on CXR. COVID PCR negative. CT did not show pneumonia and only showed bibasilar atalectasis. Pt's WBC was 37,000 on Day 2 of admission. This resolved with antibiotics. No source was found.

Atrial fibrillation; pleurisy (flank pain, diagnosed as pleurisy at the ER); pleurisy (flank pain, diagnosed as pleurisy at the ER); This is a spontaneous report from a contactable consumer. An 86-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: E13248, expiry date: unknown), via an unspecified route of administration on 23Jan2021 07:00 at single dose (Left arm) for COVID-19 immunization. Medical history included well managed hyperlipidemia and hypertension, arthritis, meningioma benign, Bell's palsy (onset was 2010) resolved with sequelae. Known allergies include Sulfa, Codeine, and Macrobid. The patient is not pregnant. Concomitant medication included duloxetine hydrochloride (CYMBALTA), losartan, hydrochlorothiazide (HTZ), desmopressin, fenofibrate. Facility type vaccine was reported as Doctor's office/urgent care. The patient experienced atrial fibrillation, pleurisy (flank pain, diagnosed as pleurisy at the ER) on 24Jan2021 20:00. Events resulted in Emergency room/department or urgent care. Treatment of IV pain medication (unk) was given. Patient had no covid prior vaccination, covid was not tested post vaccination. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events.

RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/07/2021. ON 02/20/21 WENT TO URGENT CARE WITH COMPLAINTS OF LOWER BACK PAIN AND LOWER ABDOMINAL PAIN X4 DAYS. DIAGNOSED ACUTE RIGHT FLANK PAIN AND RUQ ABDOMAINL PAIN. SENT TO ER FOR IMMEDIATE EVALUATION. ON 02/20/21 WENT TO ER FOR RUQ ABDOMINLA PAIN THAT RADIATE STO RIGHT FLANK. DIAGNOSED WITH BILARY COLIC AND CALCULUS OF GALLBLADDER WITH OUT CHOLECYSTITIS WITHOUT OBSTRUCTION. ON 02/20/21 ADMITTED INPATIENT TO HOSPITAL.

Patient with 3-7 days of weakness. Hospitalized 2/16-2/20 for fever weakness and SOB. Diagnosed with COVID-19 and UTI. Did require O2 per NC briefly. Was treated with IV/PO dexamethasone and IV/PO Cipro Discharged to home

Patient reported feeling flushed and having difficulty breathing; rapid respiratory response called, patient monitored; no medical treatment needed, was discharged home in vehicle with spouse.

THE RESIDENT STARTED HAVING SYMPTOMS OF COVID 19 ON 2/3 (COUGH AND SHORTNESS OF BREATH). RAPID TEST WAS NEGATIVE, BUT PCR TEST WAS POSITIVE. SHE RECEIVED TREATMENT FOR COVID WITH IVERMECTIN, DEXAMETHASONE, ALBUTEROL MDI, MUCINEX, AND Z-PACK. SYMPTOMS PROGRESSED AND SHE PASSED AWAY ON 2/15/21.

86 y/o female c/o throat swelling 12 minutes after receiving vaccine while in the recovery area for 15 minute recovery period. Vitals were stable, AAO x4, denied SOB, no visible throat swelling or redness, no dizziness, speaking clearly and in complete sentences, lungs clear to auscultation. EMS call @ 0922, arrived @ 0935, assessment completed, no worsening of condition, felt the same, declined transport to local ED, signed waiver. Remained in recovery for additional 15 minutes, DC from recovery @ 0950 accompanied by Adult Daughter throughout the incident, stable at DC.

The patient developed acute shortness of breath, lethargy, and confusion the morning after the vaccination. EMS was called and she was brought to the emergency department. After evaluation and treatment, she was hospitalized. Hospitalization lasted two days. No other source of the acute symptoms were found besides the recent vaccination.

In the afternoon after getting the vaccine she was eating an ice cream bar and had a time trying to eat it, it did not go down and it did not go down. She ate dinner and at 10:30 she had terrible burning that went through to her back, had shortness of breath like she could not catch her breath. Her daughter took her to the ER as the pain was so severe she thought she was having a heart attack. In the ER they ran a bunch of tests, did an EKG and took blood, she did not have a heart attack. She was admitted and monitored her. She did have a chest x-ray in the ER as well Nothing showed blood clots in her lungs, nothing in her lungs, but she still had the SOB and the pain went away. She thinks they may have given her some medicine and the pain was gone, but she still was shortness and still is today 3/19/21. She has an appointment next week to have an echocardiogram. She has had check ups with the cardiologist and her PCP since coming home from the hospital. Her PCP gave her an inhaler to use but she has not used it. She did not have any reaction to the injection site itself. Ever since this has happened has had no appetite, brain fog, shortness of breath, fatigue and nothing sounds good to eat She can taste okay, but nothing tastes good to her. She said she doesn't think she can handle this much longer, it's been over a month.

appt # 1507818 After my mother returned home approximately one hour after the vaccination, she suddenly did not feel well and lost most of her strength in her legs and could no longer stand. We placed her in a wheelchair and she then said that her throat was closing up. She said that it felt like someone was choking her. A moment later, she felt like her jaws felt huge. We quickly gave her about four or five large glasses of water (one right after the other) and quickly took her blood pressure which went up to 170/80. We then gave her one of her blood pressure pills. After this, she started to finally feel better.

Received Vaccine 1/20/21 1/21/2021 Morning: Nursing staff noted decreased O2 Saturation and put her on an oxygen mask 1/21/2021 Night: Patient found unresponsive, not breathing. DNR. Pronounced Expired

Patient experiencing nausea anxiety SOB. On-site emergency response performed assessment. Vital signs all within normal limits; patient and husband advised to continue monitoring for life-threatening signs and symptoms; further medical transportation and treatment not advised; patient advised to hydrate and wait additional time. no transportation utilized RN

Pt has a history of dementia. She reported numerous symptoms including feeling lightheaded, body aches, "puffy face, tongue and throat." Denied SOB, rash, CP or other symptoms. There were no objective abnormal findings on exam. BP 130/80, HR 67, 98%. The pt noted that she felt improved after several minutes. EMS services and ER evaluation were offered but the son declined and elected to take her home. He believed that symptoms were related to anxiety.

Fell on day after due to dizziness, compression fracture resulted from fall, shortness of breath, delusional, depression, confusion, weak legs

Pt positive Covid today. Shortness of breath, had attributed to CHF/chronic illness but testing positive today.

Patient developed symptoms of bilateral posterior chest wall pain 2 weeks after the second dose, resolved after 2-3 days, also cough, runny nose 4 weeks after vaccination( chest CT scan showed multiple nodules)then had left leg cramps, 5 weeks later developed severe left and then posterior pleuritic pain had CT A PE study with small bilateral pulmonary emboli.

The day after the first shot, my mother had bad knee pain in her left knee. It went on for days/week. After the second dose, days out she started feel very tired and bad pain in her feet that went to her hands and she couldn't get out of bed or urinate properly. Her facility doctor gave her Gabepentin for the pain but it did not help. She declined over a week or so and then She was admitted into the hospital for dehydration (March 19, 2021). The put a catheter in her to get urine out and bring her kidney function back to her normal (she does have kidney disease). Gave her more Gabepentin (which does not help pain in feet an hands) and released her to rehab. and she is now on oxygen. Rehab was bad so I got her out and released to her facility so she could receive rehab there. She declined again with the same reaction: extreme fatigue, can't walk and now urinates and defecates in an adult diaper and now breathing is very labored. She was admitted to the hospital and they can't find out why she is in this way. They did blood work, tests, scan and X-rays without any answers. They switched up meds on her and then released her to rehab since she hasn't walked in weeks/month at this point. She is regaining strength but now on oxygen even when sitting. She is 86 and walked with a walker all around her facility and when going to doctor appointments. Now she is in a wheelchair for doctor appointments since she has no strength and needs oxygen to walk. Her facility saw her decline after the second shot and my mom is very vocal and each day told them how she felt awful and it is because of the shot. She still has neuropathy in her feet and hands but it is not as painful as it originally was and it peaked and now just painful about a 5-6 on a scale of 0-10.

very fatigued; pain in her feet moved up to her hands; she couldn't walk; she was bedridden; could not urinate properly, she couldn't void all the way; Incontinent; breathing was labored; she had no strength at all; This is a spontaneous report from a contactable consumer (patient's daughter). An 86-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 86 years old on 17Feb2021 (Lot number EL3302) received in her arm at single dose for COVID-19 immunization. Ongoing medical history included Low functioning kidney for probably 15 years, Platelete condition for probably 20 years, COPD since she was in her 40's, Asthma for over 40 years, Chronic heart failure for 10 or more years, high blood pressure, acid reflux, allergies, retains water, neuropathy in hands and feet, mucous in the lungs, thyroid condition, hypo for more than 20 years, bad lower back and bad left shoulder, nerves, anxiety, to sleep, to calm her nerves, walked with a walker. Concomitant medications included amlodipine ongoing for high blood pressure; ascorbic acid (VITAMIN C) ongoing; acetylsalicylic acid (ASPIRIN) ongoing for heart condition; atorvastatin ongoing; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) ongoing for asthma, COPD; buspirone ongoing; carvedilol ongoing; clotrimazole; famotidine ongoing for acid reflux; ferrous sulfate from an unspecified date to Apr2021 as Iron supplement; fluticasone propionate ongoing for allergies and asthma; fluticasone, salmeterol ongoing; folic acid ongoing; furosemide ongoing for retains water; gabapentin from Feb2021 and ongoing for neuropathy in hands and feet; guaifenesin ongoing for mucous in the lungs; hydroxyurea ongoing for her bone marrow made too many platelets; levothyroxine sodium ongoing for thyroid condition, hypo; lidocaine hydrochloride (LIDOCAINE) for bad lower back and bad left shoulder; magnesium oxide (MAG-OX) ongoing; montelukast for allergy and asthma; sertraline hydrochloride (ZOLOFT) ongoing; sitagliptin ongoing; temazepam for nerves and anxiety; linagliptin (TRADJENTA) ongoing; trazodone ongoing to sleep, to calm her nerves; valsartan for high blood pressure; vitamin D. Historical Vaccine included first dose of BNT162B2 (Lot number EK4176) on 27Jan2021 received in one of her arms for COVID-19 immunization and experienced severe pain in her left knee. The patient received the second vaccine on 17Feb2021. A week out or so she started having pain in her feet and she was very fatigued 19Mar2021; both still ongoing, both on a week. The patient had had 2 stints at the hospital, and 2 rehabs. Both of these have very slightly improved. The patient went to the hospital due to the pain in her feet that moved up to her hands, she was very fatigued, and she couldn't walk; she was bedridden on 19Mar2021. Weeks after the shot it continued day after day after day up until 19Mar2021 where she was admitted to the hospital. The patient just had her last stint in rehab this past 2 weeks and could get up with physical therapy. Hospitalization was from 19Mar2021 to 27Mar2021. The patient could not urinate properly, she couldn't void all the way and that this occurred some time between after the second vaccine up until 19Mar2021. Those few weeks things progressed. Now she was incontinent and had to wear diapers. She urinates in diapers and defecates in diapers. The incontinence started sometime during 19Mar2021 to 27Mar2021 and it is ongoing, persisting. In the hospital they could not find anything seriously wrong with her. The patient had total fatigue and the caller begged them to give her mother a (vitamin) B12 shot. They gave it to her but there was no improvement with patient's energy. They put a catheter in her to get her kidney function back to her normal level. It was because she was not urinating properly. They ran a bunch of tests and there was not anything wrong with her. They did cardiac tests, lung tests, and XRays. The patient's breathing was labored. Started sometime after the second shot leading up to the hospital and that the patient had to be on oxygen. She said she was still on oxygen and that the labored breathing was ongoing, persisting. Reporter said all of these above listed were from 25Apr2021 to 03May2021. They did more tests but there were no answers and patient was at this point bedridden all this time; she had no strength at all, all the same symptoms were ongoing, there were no diagnoses, they were switching her meds around. The patient was on oxygen 24/7, all day when she was walking, sitting in a room in her wheelchair. The caller said she was hoping patient could get up and walk around but she was still weak. She said with time she hoped she got better on feet, got back to her normal. The outcome of the events were not resolved. Information on the lot/batch number has been requested.

Admitted to hospital 4/12/21 for acute hypoxic respiratory failure due to COVID-19 pneumonia. Treated with remdesivir (full course) and dexamethasone 10mg x1 then 6mg daily x 9 days. DVT treated with heparin IV Ibrutinib held -- CBC at baseline (WBC ranged 23.5 - 35.1) Infectious Disease MD ruled out other infections, including pneumocystis pneumonia Hypoxemia progressed to severe -- 60L high flow oxygen, unable to wean - patient does not want to be intubated On 4/22 the patient desired for comfort measures only and weaning of oxygen. The patient died on 4/25/21.

Admit 6/12 for weakness, SOB, acute on chronic HF. CXR shows interstitial lung dx not COVID PNA, WBC WNL. Minimally symptomatic, mildly hypoxic. Treated w/abx and steroid, Vit C. Pt DC'd back to SNF on RA.

Difficulty breathing; Pain at the injection site; Tired; Muscle pain; Chills; Joint pain; feeling very weak; At the injection site she had swelling and redness that went down her arm that lasted 2 weeks.; At the injection site she had swelling and redness that went down her arm that lasted 2 weeks.; She felt a little pain; rash or redness; Got the sweats after the chills; having weakness in her legs, the muscles and joints.; Having weakness in her legs, the muscles and joints.; This is a spontaneous report from a contactable consumer (patient). A 86-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EWO162), dose 1 via an unspecified route of administration, on 22Apr2021 13:00 as 1st dose, single (at the age of 86-years-old) dose on left arm for COVID-19 immunization. Medical history included prosthesis on the right arm 7-8 years ago, that is why she gets everything done on the left arm. And got COVID-19 virus, then she got the antibodies intravenously applied. The patient's concomitant medications were not reported and she would rather not give her list of medications. On 22Apr2021, after vaccination, the patient had reaction. The patient also had pain at the injection site injection, site swelling and redness that went down her arm, was tired, had muscle pain, chills, joint pain, difficulty breathing and weakness in joint. After getting the shot she felt a little pain, then a rash or redness that kept growing and growing; she felt it was little swollen. The patient stated that she got so chilled she had to put on 4 layers of clothing and 2 blankets. Then she got the sweats after the chills, so much that you could wring it out of her clothing. She reports feeling very weak and had the chills, then she went to bed and woke up with the sweats. The patient also having weakness in her legs, the muscles and joints. It was reported that everything went away after about a week, gently. At the injection site she had swelling and redness that went down her arm that lasted 2 weeks and went away. The patient furthermore stated that "she is not going bald but, losing her hair a little and the color of her hair changed from dark brown to all white now, it happens when one gets old they shrink, go bald or lose your hair". The patient was scheduled to receive second shot on 12May2021 at 11:00. She went to her pulmonary doctor due to having trouble breathing. They increased her medication for her breathing which helped a lot. Therapeutic measures were taken with medications for dyspnea. The patient recovered from all the events. No follow-up attempts are needed. No further information is expected.

Pt presented to ER with stroke like symptoms. On routine admission test, pt tested positive for COVID-19, after previously having both doses of the COVID-19 vaccine on 2/3/2021 and 2/24/2021. Notes from provider: "2. Covid 19 + despite Pfizer vaccination 2/2021 - possibly related to her MGUS and inadequate immune response, though her son (whom she lives with and has been homeless in the past) has not been vaccinated, so possibly either failure of immune response with true Covid19 infection vs false + due to exposure to son (he is planning on being tested). Continue dexamethasone and remdesivir given oxygen requirements and standard lab monitoring. 3. Acute hypoxic respiratory failure - continue Rx for Covid19 with dex/remdesivir and ceftri/azith for possible CAP, will also increase IV lasix given findings on TTE today. "

after 30 minutes of vaccine resident started to get short of breath . Was monitored during the day and vitals normal was told to go to ER if symptoms got worse. Resident went to ER at 2000 with shortness of breath. Recommendation was to not get the second vaccination body has enough antibodies and getting the first dose was enough for her.

1840 NSG staff notified that resident had fallen and was unable to get up. Upon arrival to resident, resident was lying on her right side outside of her room. Resident was severely diaphoretic and unable to state what had occurred. Resident had a blue tinge to her lips, wheezing bilaterally, equal strength bilaterally and very weak. BP 143/74, HR 66, 02 80%, temperature unable to read temporally due to diaphoresis. respirations equal and labored at 22 breaths per minute. EMS called. RN and CNA staff stayed with resident while waiting for arrival of EMS. During this time, son called resident's phone and he was updated of the situation. Upon EMS arrival at 1700, resident was regaining orientation and was no longer diaphoretic. EMS bs was 143. 02 placed on resident by EMS with 12 lead to be done on transport. EMS left with resident at approximately 1907. SJH ED called and given report to RN. DON notified.

The patient received her 1st Pfizer Covid 19 vaccine then within approximately 10 minutes she started complaining of shortness of breath and stated she "needed oxygen for my heart failure". I then directed her son to wheel her back to a room and the charge nurse grabbed the Oxygen for us. We took a pulse on room air and she was bouncing around 84-85%. At this point she began to have uncontrolled jerking movements in her neck, upper and lower extremities. She was talking during these and never lost consciousness. When the shaking started I had the nurse call 911 to get EMS on the way. She then had her O2 by nasal canula placed and it was turned up to 6L to start until O2 came up to 98%. We then slowly turned town to 3L and maintained SpO2 around 97%. Involuntary muscle jerking continued although it was a little less severe. EMS came and transferred her to the ER.

Pt. admitted to the hospital on 22 Jan 21 with Acute on chronic combined systolic and diastolic congestive heart failure; CHF (congestive heart failure); Chest pain, unspecified type; Coronary artery disease involving native coronary artery of native heart without angina pectoris; Debility; Ischemic cardiomyopathy; Shortness of breath; Systolic and diastolic CHF, acute on chronic Still admitted as of today

Patient has been under Hospice services for almost a year. She began to demonstrate a large amount of oral secretions on 1/10/21 at 2130. She was suctioned and a Rapid COVID-19 test was performed, which was negative. The COVID-19 Rapid test was repeated on 1/11/21 and was positive. Oxygen saturation was noted to be 78% on 1/12/21, and oxygen was initiated at 1133 at 3L per nasal cannula. Oxygen was increased to 4L at 1635 d/t shortness of breath. On 1/15/21 @ 0645 patient was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated.

Patient was having shortness of breath, Heart rate was 111, respirations were 44, suctioned multiple times MD notified and sent to Emergency room for evaluation

At 2am on 2/3/21 resident began having trouble breathing. She had an audible wheeze and gurgling and critically low O2 sats. She has no history of breathing issues. She did not have any issues earlier that day. She was sent to the ER and admitted to the ICU for possible heart failure.

Roughly 7 hours after receiving vaccine patient complained of difficulty breathing. Per patient's wife/caregiver, patient appeared anxious, skin color appeared abnormal, and pulse was weak and bradycardic (not unusual for patient). Albuterol nebulizer treatment attempted but patient was too anxious to complete. Gave 2 puffs albuterol oral inhaler, and repeated treatment 15 min later followed by a small glass of cola. About 30min later patient calmed, no longer short of breath and pulse strong but face remained flushed. Vitals at 9:20pm included BP 116/47, pulse 67. Following day patient had multiple involuntary diarrheal stools. Symptoms reported to provider 2/8 and noted to be resolved.

shortness of breath and palpitations starting about 15 minutes after she got her Pfizer Covid vaccine 2/8/2021. She was able to make it home, had poor sleep because of palpitations although pulse rate when she took it was not all that fast. Breathlessness eventually subsided and palpitations subsided by the following morning. There was no coughing or wheezing.

About 6 day later, she developed a low grade fever (99.6), headache, her chest was feeling heavy and tight, she was achy all over, she had chills. She had a horrible cough (deep, barky cough, non productive cough) Her symptoms continually got worse. She also had an earache. She was having trouble breathing so we went to the ER on 02/16/2021. They diagnosed her with bilateral pneumonia and fluid on both of her lungs. She was discharged from the ER same day under my care, I am an RN. The prescribed her a Zpack (Azithromycin) 500 MG for 1 day, the next 4 days 250 MG, Naproxen 500 MG every 12 hours, Albuterol nebulizer treatments every 4 hours. ER doctor believes that the vaccine may of effected her immune system. She does have a follow up with Dr. on March 2nd. She is improving. She still has a mellitic/bitter taste in her mouth from the first vaccine. She is doing better but not completely over it.

After receiving the vaccine client became flushed, clammy, labored breathing, LOC, and had seizure like activity. After she came to, she c/o not feeling good and lightheaded. She was taken by ambulance to the hospital. Husband said they ran several tests. She continues to sleep a lot and is sore all over.

Pt received initial dose on 1/5/21, diagnosed with COVID-19 on 1/8/21, treated with monoclonal antibodies on 1/13/21. Pt experienced CHF exacerbation, anasarca, and renal failure during acute illness. Pt also treated for pneumonia during this time. Pt was considered terminal status on 1/25/21. She received second COVID-19 vaccine on 2/15/21. Pt then experienced increased difficulty eating and taking medications this same day, in addition to hallucinations she was experiencing. Patient subsequently died on 2/16/21.

Patient presents to ER from EMS for SOB and confusion. Of note, patient's husband passed this morning. Troponins elevated. Chest xray shows edema and likely left lower infiltrate. Patient admitted and started on IV antibiotics, Lasix, aspirin, nitroglycerin, and albuterol nebulizers. Patient is currently still admitted.

She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.

Patient was AAOx3, ambulating independently prior to obtaining vaccine. Medical Assistant gave patient vaccine in Left Deltoid. Patient ambulated to observation area and sat in a chair. Five minutes into her observation, patient reported not feeling well. Medical Assistant notified Nurse Practitioner. Upon exam, patient was pallor, eyes intermittently rolling back, lethargic and unable to keep her head upright, nauseous and dry heaving, developed rigors, unable to verbally communicate but did nod her head yes to having difficulty breathing. No hives or rash noted. Epinephrine 0.3mg Pen (Lot # 0FM406, Exp Feb 2022) was administered in Right Deltoid. 911 was called by the Vaccine Clinic Supervisor. Vitals: Temp 97.7, HR 77, BP 134/76 (sitting), Pox 96% Room Air. After Epi administration, patient continued to be lethargic and the only thing she stated was "I do not feel well" but was able to communicate with head nods. EMS arrived and patient was taken to a Hospital.

I was fine friday, my arm never hurt...awoke at 3AM and could not sleep so read and fell asleep and awoke at 9:00AM...got up and proceeded to do daily chores....and sudenly i did not feel very good, had a head ache, chills, body aches, trouble catching my breath, stomach discomfort, (not an feeling like i was going to be sick to my stomach, but just did not feel like eating anything), was dizzy, and very tired....the worst was the disorintation....was afraid i was going to pass out....laid down and fell asleep...when i awoke an hour later i felt worse....fell back asleep for another couple of hours....drank a lot of water, ate some cheese and crackers late in the day....slept thru the night and woke up on Sunday morning feeling fine....again arm never was sore....I have described all the symptoms i had on Saturday April 3rd.....i do not know what else you want

I'm concerned about COVID vaccine possibly triggering a recurrence of post herpetic neuralgia in my mother, who hadn't had post herpetic neuralgia since 2015 14 hours after dose 2 of COVID vaccine administered on 2/23, patient awoke with sudden onset severe right ear and forehead pain, site of her initial herpes zoster rash in 2004. No visible rash or changes on eye exam (Pt is taking valtrex for eye sequellae of zoster). Other symptoms have included fatigue, bilateral axillary and neck lymph node tenderness, and some breathing discomfort. All symptoms are much improved but persist now (4/12/21).

After 1st dose of Pfizer: Nausea, and trouble breathing (Oxygen went up and down from 90 to 95) - Took to Dr and advise to watch oxygen levels After 2nd dose of Pfizer: Nausea, Dry heaves, Stomach Pain, Head Aches, Back Pain, Loosing Control of Bladder (Kidney Failure), Trouble Breathing (Oxygen went under 90) - Took to her Dr and she said to take her to the Emergency Room due to her Oxygen going below 90. I took her to Hospital.

PT STATES HE HAS SOME TIGHTNESS IN HER THROAT. SHE DENIES CHEST PAIN OR THE PAIN WORSENING. SHE ARRIVES AT THE MED OBS 1 VIA WHEELCHAIR AT 1502. SHE DID NOT WANT TO GET OUT OF THE WHEELCHAIR AND SHE DID NOT WANT VITALS TAKEN. HER FRIEND WITH HER STATED SHE IS VERY ANXIOUS AND NEEDS HER NERVE PILL. AT 3:08 HER PULSE WAS 65 OXYFEN SATS 99% ROOM AIR. SHE DENIES WANT FOR WATER OR SNACKS. 1521 PATIENT WAS TAKEN TO THE EXIT VIA WHEELCHAIR, HER FRIEND, AND STAFF

Pt received first COVID Pfizer vaccine on 3/2/21 and second vaccine dose of Pfizer on 3/23/21 and tested positive for COVID 3/24/21 was admitted through the ED on 3/24/21 with decreased oxygen levels (50%) and SOB. Admitted to the floor on 3/25/21, Patient was never intubated but was put on continuous BiPap. Patient treated with acetaminophine, albuterol, solumedrol, and remdesivir. Patient expired on 4/15/21. Cause of death was secondary COVID pneumonia and acute respiratory failure.

ED to Hosp-Admission Discharged 5/19/2021 - 5/24/2021 (5 days) Last attending ? Treatment team Acute respiratory failure with hypoxia DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission From admission " Patient is a 88 y.o. female who presents to the hospital today withincreasing weakness, falls over the last few days. She has not been eating or drinking well. It appears she recently started a sulfonylurea. EMS arrived blood sugar 58 and upon arrival to the ER blood sugar was 35 and she was lethargic. Given orange juice and a dextrose bolus with improvement of her blood sugar. Room air sat was 88% on room air however she only feels short of breath but she did not wear oxygen at home. Family member has Covid but she does not endorse any contact with them. In ED she was found to be positive for COVID19, with AKI and SIRS and internal medicine was asked to admit the patient." Hospital Course Patient mandatory medical surgical floor. She was found to have acute hypoxic respiratory failure due to COVID-19 pneumonia. She was found to be 88% on room air and was requiring 3 L of nasal cannula oxygen fourth her first 3 days of admission. She received treatment for her viral infection with IV remdesivir as well as IV dexamethasone to complete 5 days. She also was treated with azithromycin and ceftriaxone. However this was later stopped as her procalcitonin level was not negative. Because her urine showed pyuria she was continued on IV ceftriaxone. However her culture only grew 30,000 colonies of E. coli in 50,000 colonies of Streptococcus and get gnosis. She was fully treated for a UTI. She was successfully weaned off of oxygen onto room air on May 23 and remained stable overnight into the day of discharge. She was seen by physical therapy due to her history of ambulatory dysfunction and rehab was recommended for her. However the patient refused she felt that she had enough family support and assistance at home to return home. Home services were also recommended including home physical therapy which the patient also declined. She will need to follow-up with her family doctor in the next 7 days. A referral for pulmonology was also made on the day of discharge for 1-2 days.

Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 3/24/21). Patient was admitted to the hospital for cough and wheezing and diagnosed with COPD exacerbation. Her COVID PCR was negative on 5/22 and 6/1 and then positive on 6/3. Patient now with cough and increasing SOB requiring 3L NC.

5/5/21 Admission to Med Surg: The patient is a 88 y.o. female with a past medical history notable for CHF, diabetes, CAD, hypertension, hyperlipidemia. The patient presents for evaluation of worsening issues with swelling and shortness of breath. Patient was found to be 3-5 lb from baseline weight. Patient shows significant lower extremity edema in addition worsening rales bilaterally. Patient is on the fevers or chills. Patient struggle with fluid balance due to dietary need to restrictions in addition to patient's diabetic diet. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Patient's who was agreeable to in-patient diuresis 5/19/21 ER: 88 y.o. female who presents with chest pain. Patient reports that approximately an hour and half ago while at assisted living facility she began having chest pain. Patient describes her chest pain as located across the central part of her chest. She describes it as a pressure. She currently gives it an 8/10. Patient denies any radiation of the pain. Patient does report associated shortness of breath, lightheadedness, dizziness, but denies nausea, vomiting, or diaphoresis. Patient also reports feeling her heart racing in her chest. Patient denies prior history of atrial fibrillation. Bedside monitor shows AFib with RVR. Patient also reports recurrent swelling of the bilateral lower extremities dx: NSTEMI Transferred to a different hospital

Resident was vaccinated. Pt was admitted on 6/28 with dx of pneumonia, cdiff and sepsis. On admission pt noted to have dry cough and lethargy. Pt had signs of aspiration and dyspnea and was sent to ED for evaluation within five hours of admission to Beecher Manor. She was treated for aspiration pneumonia w/diagnosis of pneumonitis r/t food and vomit. She was re-admitted to Beecher Manor on 7/3 with orders for Augmentin PO 7/4 - 7/9. She continued to decline w/plans by family to begin Hospice care. She expired during process of initiating hospice care.

Patient was out of breath after walking down to clinic from her room. She said she just needed to catch her breath and was given a few minutes to sit prior to vaccination. Pharmacist asked her if she felt okay today, which she replied yes. She stated the nurse assisting her down the hall was walking to fast for her. After her vaccination patient remained seated for 20 minutes and still reported shortness of breath. A pulse ox was placed on her finger and her pulse was ranging between 44-80 and O2 range was 94-98. When her pulse rate would drop, she had uncontrollable body tremors. EMS was dispatched within an hour after vaccination and patient was transported to the ED.

Patient experienced moderate to severe symptoms of shaking, trouble breathing, jaw tightness, tightness in mouth, numbness and tingling in lips, difficulty talking, upset stomach, tremors and numbness to left side of face

hx of copd and asthma. walked to bathroom and when she got back, daughter notes sob and wheezing. little dizzy. she is not on home O2, but does 3 neb treatments daily at baseline. I gave her 2puffs of her own neb and observed her in her car. initially 92%ra and puls 70. diffuse b/l wheezing on auscultation. no jvd. stayed with pt after MDI and noted improvement to 95%ra and felt better. patted back for pulmoanry therapy, she coughed and felt better. gave my cell to call me if she had issues. repeat ausculatation after 25min with almost no wheezing. sat 97-98%.

The day after receiving the Covid vaccine, I began having shortness of breath. I had no fever. my blood pressure stayed normal, however, my pulse was elevated and my heartbeat accelerated whenever I exerted myself. This continued from Wednesday to Saturday when I began to feel somewhat better.

Physician, patient's son, and husband standing at patient's side throughout event. Within 5 minutes of receiving the 2nd COVID 19 vaccine, the patient began to report that she was feeling sharp shooting pains in her legs, arms and chest. The patient reported feeling anxious prior to the injection. Within 6-7 min, the patient began to experience difficult breathing at which time 911 was called. The patient was given 1 dose of Epi and one dose of Benadryl IM, which eased severity of the symptoms. The patient's vital signs remained within normal limits until time of transport to local hospital.

PATIENT BECAME SHORT OF BREATH AFTER VACCINATION. EMS PRESENT AND TOOK CARE OF PT. O2 SAT 91%, O2 ADMINISTERED, O2 SAT 97% ON 2L/MIN. PATIENT'S DAUGHTER STATED HER MOTHER WAS "VERY ANXIOUS ABOUT GETTING SHOT". PATIENT TRANSPORTED TO HOSPITAL.

4 days after receiving the vaccine on 1/31, she experienced burning in her legs and feet; a few days later she had some SOB with activity (walking up stairs), lethargy and "tired" feeling in her arms and legs - all of these symptoms persist

Presented to emergency department on 2/20/21 with shortness of breath and nasal congestion with symptoms starting 2 days prior to presenting. Had virtual appointment on 2/19/21 with primary care provider for sinus infection and was started on Bactrim. Patient was discharged on 2/23/21 then presented back to ED on 2/23/21 and was re-admitted. Patient is currently admitted at the time of reporting.

My mother had an "adverse event" to the first dose of the Covid-19 PFIZER mRNA vaccine. Her whole upper arm became swollen (inflammation) and somewhat "hot to the touch" and was reddish in coloring. The inflammation did NOT look like a golf ball, but rather like a small hill on her upper arm, with a slope. After that, she reported to me .... that she was getting "winded", on walks with her best friend. They both live in a senior citizen residence center, which is NOT an "assisted living" facility. Now, the swelling (inflammation) is gone. My mother has now had the 2nd dose of the Pfizer vaccine and yesterday .... she did NOT report, any adverse reactions (yet) from her second injection.

Patient presented to ED with SOB for 2 weeks. Patient was treated with IV Lasix. Cardiology suspected heart failure exacerbation and patient was discharged home. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

1/29 /21 Increased fatigued, congestion, BP elevated Stat CBC/BMP/CXR. CXR. CXR-CHF with superimposed bilateral infiltrates and bilateral pleural effusions. N.O. Rocephin 1gm IM QD x 7 days. CBC am. Consult with cardiology. 2nd covid vaccine not given. 2/2-2/5 Sent to ER for ongoing significantly elevated BP's. Remains on Rocephin. Hospitalized 3 days for Acute on Chronic Diastolic and Systolic Heart Failure-Diuresed with IV Lasix, Multiple changes in medications by cardiology for poorly controlled HTN. Head CT negative, Covid negative. 2/5 Readmission from Facility-Followed closely by cardiology. Losartan was increased, Hydralazine was increased, Norvasc was increased. Continue Atenolol. Monitoring daily weights and vital signs. Resident with increased lethargy and then behaviors at times, and refusing meds. Oral intake poor. Continued on Coumadin for A-Fib with monitoring of INR. Palliative consult ordered. Continued to be followed by Mental Health and APRN in addition to PCP. 2/6 CBC/BMP/CXR-BUN/Creatinine elevated 44/2.2 and upon readmission to facility. MD changed from Lasix to Demadex. CXR-Continued PNA. Started on Rocephin 1gm IM x 7 days. 2/8 MD visit. Palliative consult ordered 2/11 Critical labs with elevated BUN/Creatine and Na level. MD ofered hospitalization to ADPOA who declined and wanted to pursue Hospice instead. Resident was seen by APRN from Home Health and Hospice Services who discussed plan of care with ADPOA requested comfort care and no further hospitalizations. 2/12 Resident admitted to Hospice Services. Compassionate visit with ADPOA 2/14 resident with further decline, periods of apnea evident, comfort maintained. 2/18 Passed at facility with Hospice services in place and compassionate visits with ADPOA

Breathing problem. Couldn't get air in. Had fever of 103, headache, chills. Arm pain as expected, swelling red and raised hot area. table salt for breathing p roblem and it helped me breathe. I was not well for over 2 days. 3rd day I began to feel better but 100% day 4. Please note I would never have made it to the hospital alive, not being able to breathe. I did not get the 2nd shot!!

reports acute onset posterior headache, lightheadedness, and SOB post-vaccination (Pfizer) at 11:15 am. AMR emergency response notified, EKG benign. Pt hypertensive to 175/80, typical BP measurements reportedly 110s systolic. Pt reportedly has not had anything to eat for 8-12 hours. CBG on site at 97 per AMR. Transported to ED

patient received her covid vaccine per her record: 1/3 and 1/24/21. Patient presented to Facility 4/20/21 diagnosed with COVID, patient died 4/23/21 due to hypoxic respiratory failure/ bilateral pneumonia due to covid.

Patient in observation and reported increase in heart rate, chest tightness and difficulty breathing 30 minutes after injection. Patient remained stable, but reported worsening symptoms and was transported to ED for further evaluation

she almost passed out however she was able to grab unto the bed; bowel movement with quite a bit of blood; Is having difficulty breathing; Slight temperature; Wakes up in morning with sweat; Food just doesn't taste right; Has been drinking a lot of water because she wants water; Mouth is so dry; Walking is much worse, has to hold onto everything; Weak; Not eating like she used to, eating the minimum to survive; Coughing and bringing up phlegm; Gets chills once in a while; Sleeping an awful lot; Coughing and bringing up phlegm; she had pressure in her heart; pain as aches and pain; Flu-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp. An 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201; Expiration Date: 30Jun2021),via an unspecified route of administration, administered in Left Arm on 19Feb2021 in between 2:15-2:30 as 1st Dose,0.3mL, Single Dose for COVID-19 immunization. The patient's medical history included diabetes mellitus, blood pressure abnormal(High blood pressure), hospitalized prior to the COVID Vaccine. It was two years ago and she was hospitalized for COPD. Three years ago she went to visit her sister in and wound up with the Flu and Pneumonia where she almost died. She was still here. Cardiac disorder, atrioventricular block, heart problems for several years, Had a blockage, blood glucose abnormal, Had the Flu and that was how she felt. When she had a hard time breathing she did not know if it was the flu or pneumonia. So much stuff was put in her. Needles were being plunged in her. She did not know what she was given. It was a really rough time. Patient also broke her finger in Dec2020. Infection set in after her finger was set with a metal plate. The metal plate dug into her finger and created an infection. She was in excruciating pain. The metal plate was taken off and has been told she will have a mullet finger. Stated kids get it from sports and is where the finger just hands. The finger doctor told her there was nothing that can be done because the bone has disintegrated into her body. Concomitant medications included insulin glargine (LANTUS)Product strength and count size dispensed: 100 units ml 3mg prefilled pen, was originally taking Lantus, 20 at night, but it wasn't doing the job. Dose was split to 15 in the morning and 15 at night, NDC: 0088-2219-01,Lot: OF7051A,Exp: 2023 ; Insulin (HUMALOG) NDC: 0002-8799-01 ,Lot: Unknown, Expiry:Jun2022,Had to get into light to read Humalog. Didn't see lot number, taken for blood glucose abnormal. Doesn't take that often. Only takes if blood sugar is over 150. No History of all previous immunizations with Pfizer vaccine considered suspect were provided. With regards to prior vaccination within 4 weeks, stated she fell and hit her head and had to get four staples in Dec2020. She was given a vaccine for tetanus and diphtheria and stated maybe a slight rash or achy, a little red, but never any other reaction. No Additional vaccines administered on same date of Pfizer suspect. Did not require a visit for AES. The patient received the 1st dose of the Pfizer covid vaccine on 19Feb2021, scheduled for her 2nd dose on 12Mar2021. She says this was the 5th day of her having flu-like symptoms, which she previously reported. This morning she had pressure in her heart for which she took Nitro. As she was trying to get to the bathroom, she almost passed out however she was able to grab unto the bed and did not fall. She then went to the bathroom and had a bowel movement with quite a bit of blood. She does report a history of heart problems for several years. Had a blockage. Had one COVID Vaccine and now has all kind of Flu like symptoms. Had a slight temperature. Wakes up in the morning with sweat, pain, and food just didn't taste right. Had Flu before and was having a lot of Flu like symptoms. Was having difficulty breathing and coughing. Also had COPD. Wanted water and had been drinking a lot of water. Her mouth wa so dry. Stated she was sort of used to the difficulty of breathing. Had been in the hospital for COPD. Stated her walking wasn't that great to begin with, but now was much worse. She had to hold onto everything. was not eating like she used to, only the minimum to survive. She was weak. Had been having difficulty breathing a lot before the COVID Vaccine. Didn't know if she COVID Vaccine just got it started a little more. Was constantly blowing her nose and bringing up a lot of phlegm, but she knew that was from her COPD. Got the chills once in a while. Was freezing and then warm. Has been sleeping an awful lot. The patient underwent lab tests and procedures which included body temperature: 99.4 slight, glycosylated haemoglobin:10.Wanted to finally go out a little bit and walk around. Had been in the apartment for so long. Went back for second COVID Vaccine on 12Mar2021. Wanted to get back into the swing of things. Therapeutic measures were taken as a result of, she had pressure in her heart (cardiac discomfort). The outcome for the events was Unknown.

burning sensation in feet and legs; weakness in arms and legs; shortness of breath; feeling like a tight band is around feet; Lethargy; This is a spontaneous report from a contactable consumer (patient). A 88-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported) via an unspecified route of administration, administered in arm right on 31Jan2021 10:00 (at the age of 88years) as single for COVID-19 immunization. Medical history included high blood pressure. Concomitant medications included lisinopril , hydrochlorothiazide , diltiazem and omeprazole. No other vaccine in four weeks. No covid prior vaccination, no covid tested post vaccination, no known allergies. On 04Feb2021 12:00, the patient experienced lethargy, weakness in arms and legs, shortness of breath, burning sensation in feet and legs, feeling like a tight band is around feet. No treatment was received for all events. The outcome for all events was not recovered. Follow-up attempts are completed. No further information is expected.

Fever chills; Weakness; Muscle soreness; Tiredness; Joint pain; Cough; Hurts to Breathe; Hives at Injection Site/hives all over; Skin and Eyes Burning and Itching/her whole body is hot and itching; Couldn't Sleep; sweating and felt hot; Skin and Eyes Burning and Itching; sweating and felt hot; Sinuses and Nose Plugged Up; Diarrhea and Upset Stomach; Stomach Hurting; Diarrhea and Upset Stomach; Stomach Hurting; No Appetite; Sinuses and Nose Plugged Up; Diarrhea and Upset Stomach; Stomach Hurting; sickness; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 88-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:30 (Batch/Lot Number: EN6202) as dose 2, single for covid-19 immunisation (reason: giving them and because she had bone marrow disease and doctor thought she should get it) at doctor office. Medical history included 2 aortic valve replacements (last one was replaced 3 years ago in May and the first one was replaced 5 years ago), ongoing autoimmune disease and ongoing acid reflux, bone marrow disease and Covid. Concomitant medication(s) included prednisone (5mg once a day by mouth; she had been taking it for a number of years for a condition auto immune disease and she has to take it for the rest of her life) taken for autoimmune disorder, and pantoprazole (40mg once a day by mouth; started probably 5years ago) taken for acid reflux, start and stop date were not reported. The patient previously took BNT162B2 (Lot: EM9809) as dose 1, single on 12Feb2021 for covid-19 immunisation; flu vaccine for asthma (when she got a flu shot years ago, she had to go to ER for an asthma attack from that; it was way back in the 1990s; NDC, Lot, Expiration: Unknown). No investigation assessment was done. No vaccines administered on same date of the Pfizer suspect. No Prior Vaccinations (within 4 weeks). Family medical history relevant to adverse event was none. The patient experienced sickness on 05Mar2021; fever chills on an unspecified date, sinuses and nose plugged up; diarrhea and upset stomach; stomach hurting; no appetite on 08Mar2021; sweating and felt hot; and skin and eyes burning and itching/her whole body is hot and itching; and couldn't sleep on 12Mar2021; hives at injection site/hives all over on 14Mar2021, hurts to breathe on 15Mar2021; cough on 17Mar2021; tiredness; joint pain on 21Mar2021; muscle soreness on 22Mar2021, weakness on 23Mar2021. Therapeutic measures were taken as a result of this with BENADRYL, Z PACK, MYLANTA AND TYLENOL. Clinical course was as follow: The patient stated that she wondered if should've even had the vaccine. The patient had Covid in Mar2020 (a year ago in March) and she had long haulers until Jan2021. In March, her hematologist called and said she could get vaccine and stated that she shouldn't have. She stated that the second one made her really sick. This sickness was getting too long. Her second dose of the vaccine was on 05Mar2021. She was so tired; stated she doesn't feel good. She stated that she felt like she has long haulers all over again, it was horrible. Stated she felt like she shouldn't have gotten the second one. States she was doing okay with first one. Caller states that she already gave up a whole year of her life because of this. She tried to call before, but she didn't wait to talk to someone, she had to go somewhere. The patient stated that she had hives, tiredness, problems with her intestines, got really sick, her skin and eyes started to burn, she felt like she had hives all over, her skin was burning, she was sweating and felt hot, stated on the 14th it really got bad, her whole body was hot and itching. States that she took a BENADRYL and felt better the next 2 days and then started getting sinuses and nose plugged up and it hurt when she was breathing, had a slight fever, and her skin was itchy. She states that she went to doctor on 15Mar2021 (physician office visit), and he didn't think too much of it because her oxygen was okay. States that she felt worse, she was coughing bad, felt terrible, her muscles ache, and when she was hot, she couldn't sleep, now all she wanted to do was sleep and she had fever and chills. She was supposed to do exercises, but she couldn't, and it started two days ago. States she was not coughing as much but it was still hard and hurting. It was some of her joints, not all of her joints were hurting like when she had long haulers. Fever and chills started when her sinuses started acting up. The fever and chills kept getting occasional slips in and out. Her fever was not high but enough to get the chills. Sinuses and nose plugged up: it came and went with MUCINEX and it helped a little. Her intestinal problems were diarrhea that started on 08Mar2021 and upset stomach. She had a problem and it hurt terrible for days after. No appetite lasted for one week, so probably ended 15Mar2021. Caller states that she felt a little better but can't get rid of her cough. Couldn't Sleep: started when she had the burning and lasted a little after because she had to get herself together again. She could only sleep three hours at time. Skin and Eyes Burning and Itching: The burning and itching went away for a while, but it was back again because she had been lying in bed and tired, stated that it was not so bad. The burning stopped 15Mar2021 when the hives were gone, but she stated that right now it was back, her skin gets hot and then starts burning and itching. Patient stated that she did not have too much problems with first but this second, oh my god. She thought she got it too soon after having long haulers. She got rid of that in Jan2021 and was feeling good but now she felt terrible again. States there were no tests, she didn't have any. She was so weak, and she was having a hard time now, and she was doing so good. She was worried about her heart and valves. She guessed that call handler couldn't help her either, she stated that she didn't know what to do to feel better. She thought she had better call and report it. She has already gone to doctor and had only gone to him for 2 years, but hopefully he knew enough about her. She states that she probably should call him because she wasn't getting any better. The outcome for hives at injection site/hives all over was recovered on 15Mar2021, skin and eyes burning and itching/her whole body is hot and itching was not recovered, muscle soreness was not recovered, weakness was not recovered, cough was not recovered, tiredness was not recovered, joint pain was not recovered, fever chills was not recovered, sinuses and nose plugged up was unknown, diarrhea and upset stomach; stomach hurting was recovered on 11Mar2021, hurts to breathe was recovering , couldn't sleep was unknown, no appetite was recovered on 15Mar2021, sickness was unknown, sweating and felt hot was not recovered , sinuses and nose plugged up was unknown, skin and eyes burning and itching was not recovered, sweating and felt hot was not recovered. No follow-up attempts are possible. No further information is expected.

Died of COVID-19 illness on 06/14/2021 Immediate Cause of Death: Acute respiratory distress syndrome with respiratory failure Due To or as a Consequence Of: COVID-19 infection Interval between Onset & Death: 4 days COD listed as ACUTE RESPIRATORY DISTRESS SYNDROME WITH RESPIRATORY FAILURE INTERVAL BETWEEN ONSET & DEATH and COVID-19 INFECTION INTERVAL BETWEEN ONSET & DEATH

Resident received 1st dose on 1/4/2021. On 1/6/2021 resident having SOB, increased weakness with O2 sats at 91% RA. On 8th resident sustained a fall, O2 sats 88-92, dizzy, weakness. Rapid COVID test performed with negative results. Evening of 8th resident was lethargic and diaphoretic with fever of 99.9. Resident transferred to ER, on 5lt of oxygen. Resident returned from the ER on 1/9/2021 with new diagnosis of Leukemia and orders for hospice. Continued with fever, crackles and N/V and loss of appetite from the 9th and 10th of January. Resident expired at 820am on 1/11/2021.

She received her vaccine at 11:25am, she went through the observation area and returned to her room. Three hours later she reported to her care givers that she was short of breath. Her O2 sats were 83%. She has no wheezing. She was given O2. 911 was called and she was transported to the hospital.

Patient recevied the COVID-19 vaccine on 1/5/21 by the Vaccine clinic #1. Patient tested positive for COVID-19 by rapid testing on 1/6/21. She demonstrated poor appetite and fluid/food intake and an IV of Normal Saline was initiated on 1/7/21. Oxygen saturation was initiated on 1/12/21 at 4L per nasal cannula. for shortness of breath. On 1/22/21 at 0310 Patient was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated.

family states seemed short of breath since after the covid vaccine. Staff said beginning on 1/22/21 the patient seemed sluggish, more tired, and nausea noted. She stayed in her room more after the vaccine because worried about giving/getting COVID to others. was talking on the phone at 11:30 PM on 1/26/21 to staff person about temperature of room. at 12:15 AM on 1/27/21 staff noted not breathing, started CPR and called EMS. When EMS arrived they stopped the code because she was too long deceased.

Client stated shortness of breath. Paramedics assessed client and client was transported to Hospital.

Shortness of breath; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283, Expire Date: Apr2021), via an unspecified route of administration on 15Jan2021 09:00 at single dose, right arm for covid-19 immunization. Indication reported as "Hopes she wouldn't get COVID", Stated that was why she got the Measles vaccination. The patient's medical history and concomitant medications reported as none. The patient previously got flu shot for immunization in Oct2020. The patient experienced shortness of breath on 17Jan2021. Caller told the woman administering it that she had been short of breath and was advised it was alright to receive the COVID-19 Vaccine. The patient had been really short of breath ever since. She wasn't very short of breath before the COVID-19 Vaccine. She was more so short of breath after the COVID-19 Vaccine. Shortness of Breath was noticed increase on 17Jan2021 at night. She was fine during the day, but could not lie down to go to sleep in bed. Sat up all night. Then it just came and went. Sometimes thought it was gone, but shortness of breath came back. The patient called doctor and was advised to go into an urgent care. She was going at time of the report. Relevant tests reported as none, regular check up at doctor. She wanted to know if she could get the second COVID-19 vaccine on 06Feb2021. The outcome of the event was unknown.

Got sick; Headache; Shortness of breath; Passed out; Dizzy/ Dizziness; Tightness in her chest; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date unknown, first dose, intramuscular on 26Jan2021 at single dose on right arm for COVID-19 immunization. Medical history included mastectomy, surgery for metaplastic carcinoma. She received 4 units of blood and reacted to the blood and itched from her head to toe and they treated her with prednisone for that. She said that the metaplastic carcinoma was 10 inches big and half of her front was removed. Other medical history and past drugs included allergic to Bactrim, Sulfa drugs, Cortisone, Zocor, Keflex, Macrodantin, Penicillin, Vicodin (took three times and thought she was going to die; coughed for a year and couldn't even sleep because she developed Pericarditis), Benazepril, Levaquin, Losartan, Niaspan (whole body turned red), Pravastatin. On 07Jan2021, she had an appointment with her doctor who first advised her not to take the vaccine because of all of her allergies but she said there is an antidote if she has a reaction so she said she could take it. She had the first dose of the vaccine on 26Jan2021 and had a bad reaction. She was very dizzy and got sick. They didn't catch it at the vaccination site because they only had the patients wait 15 minutes. Her drive home takes 10-15 minutes. She thought she couldn't drive home because of the dizziness. She got a tightness in her chest and started getting so dizzy that she ran into the living room and slept on the sofa because she couldn't handle it anymore. It was reported that she passed out from about 12:00-15:00. She was completely out. She took a Tylenol right after the shot for dizziness and sick because when she told her healthcare professional about the symptoms, she said to take a Tylenol. She also had shortness of breath on 27Jan2021. This morning (28Jan2021) she had a headache but she was feeling much better. The caller asked if she should get the second dose due to her reaction. The patient stated she has a whole list of allergies that she gave the other agent. The patient stated that she doesn't think she will take the second shot. She also stated she takes Tylenol after the Flu shot so she doesn't get so sick. The patient mentioned that her physician does not know about any of this and said that she received the vaccine at a hospital. She said that she only contacted her doctor to notify her that she was dizzy. She was directed to take Tylenol. She said that she did take Tylenol as directed by the people administering the vaccines too and she did get sick. The patient said that it helped a little and she knows that it was not the Tylenol that caused this. She does not want to get the second shot if she gets sick like this. The patient said that the fact sheet said to call 911. The shot did not hurt her at all, and she did not know that she even received it. She said that the person who administered the vaccine was very good. The outcome of the event headache was recovering, dizziness, shortness of breath recovered on 27Jan2021, Tightness in her chest, passed out was recovered on 26Jan2021 and sick was unknown. Information about Lot/ Batch has been requested.

At approx. 11:42, pt. reported "burning on inside." Pt. was taken to first aid area of clinic. Pt. denies any rash, puritis, difficulty breathing, or throat irritation. V/S @ 1148: 97.9, 80, 180/95. Pt. started to report worsening of symptoms ("burning on the inside.") Benadryl 25mg PO administered per standing order at 11:52. Additional Benadryl 25mg PO given per standard order @ 1202. Nursing staff continued to monitor patient and @ approx. 1207, pt. developed shortness of breath and throat tightening. Epi 0.3mg IM administered per MD order at 1208. Pt. started to show improvement of symptoms at approx. 1210. Pt. reported that throat tightening was subsiding. EMS contacted. BP: 193/107 @ 1213, 181/95 @ 1219. Paramedics arrived at 1223 and patient transported. Daughter followed.

Patient is a 89 years old female with a past medical history significant for hypothyroidism and hypertension. She was in her normal state of health prior to receiving her first dose of the COVID-19 vaccine (Pfizer). She has no known documented allergies. After her routine 15-minute wait., she was walking to her car with her son when she become short of breath. She was brought back into facility via wheelchair. She appeared to have labored breathing with use of accessory muscles. Vital signs showed BP185/88, HR 78, 93% room air. Her heart rate was regular, lung sounds with expiatory wheezing in all fields. She was given Epi 0.3 mg IM and neb treatment. Transported to ED via EMS.

Patient receive her 1dose of covid vaccine at 0900. At around 0915 pt stated she feels nauseated and was having a hard time breathing with her mask on in a confined space. RN took her out to the hallway with door opened for ventilation. Patient felt better right away. Patient stated she felt better and want to go home. RN stayed with patient till 1000 and walk patient to her car.

Patient presented to the ED 2/6/2021 with increasing SOB and found to have abnormal labs as an outpatient. Patient was found to be COVID positive on 2/6/2021 as well. Patient was discharged on 2/9/2021 for acute decompensations diastolic HF. At 2/19/2021 visit with Nephrology, patient found to have hypervolemic hyponatremia, not responding to oral diuretics and decision was made to manage as an inpatient. Patient found to have cardiomegaly, mild pulmonary vascular congestions with small bilateral pleural effusions, EF 59%, severely elevated pulmonary artery systolic pressure, and had a AKI. Patient did not improve with diuretic therapy. Hospice and comfort care measures were pursued and patient expired on 3/1/2021.

The patient presented to the Medical Center Emergency Department 03/30/21 for evaluation of malaise and cough that had been present for approximately one week. The patient also complained of shortness of breath, fever, and low O2 saturations. The patient's daughter reported the patient had been more weak and complaining of muscle aches. The patient's caregiver testes positive for COVID-19 1-2 weeks prior. The patient received both Pfizer Vaccines and was more than 2 weeks out of her most recent vaccination per daughter. No additional details regarding the vaccines could be obtained. The patient remained in the hospital and was treated for acute hypoxemic respiratory failure secondary to acute COVID-19 Pneumonia. She was stabilized on 2L supplemental oxygen and discharged home 4/3/21. She received dexamethasone, antibiotics for concern of secondary bacterial pneumonia co-infection, oxygen, mucolytics, antitussives, incentive spirometry, and remdesivir.

Patient received both doses of Pfizer COVID vaccine (1st dose on 2/24/21 (lot #EN6203) and 2nd dose on 3/19/21 (lot #ER2613). She developed difficulty breathing and tested positive for COVID on 4/8/21. She was brought the ED on 4/9/21 and was admitted to the hospital. Infectious Diseases was consulted and has been following patient during her hospitalization. COVID treatment may be started if patient's family decides that they want aggressive treatment versus pursuing comfort care due to patient's multiple medical issues.

Excessive Fatigue, Shortness of breath, little interest in anything, runny nose, cough & congestion. At about day 4-5 after second vaccine, she became more fatigued than usual, developed a mucousy cough, and had little interest in doing anything. After day 10, a nurse came in and took vitals and suggested she see a physician for possible fluid in lungs and an irregular heart beat. Monday, April 12 we took her to Urgent care as her Dr. couldn't see her until we went there first. We will do a follow up with her regular physician next week.

04/04/2021 - Assessed at start of shift. Family at bedside and aware of condition. Left after assessment. Unable to arouse. BP 97/64 P 71 R 30 and shallow 02 sat 80% with 02 per NC in place at 2 LPM. Afebrile at 97.7. MS given at this time. Upon entering room at 2245 Pulse faint and R very shallow at 4. Resp. and pulse ceased at 2300.

After receiving a COVID vaccination, patient experienced mild SOB, tongue swelling and tingling. She was treated with Benadryl while she was at the vaccine site.

Patient had increasing dyspnea - difficult to assess whether this was from her aortic stenosis, but this progressively worsened after the vaccine. She a lower extremity dopplers and CT-Angiogram consistent with a pulmonary embolus. She was initially started on IV heparin, which was transitioned to eliquis. Her symptoms improved.

Patient became symptomatic with shortness of breath on 06/04/2021. She was admitted into the hospital on 06/06/2021. She was discharged on 06/08/2021.

Patient experienced malaise and shortness of breath within 2-3 hours of getting the shot. Progressed over the next 48 hours and then presented to ER where she was diagnosed with acute hypoxic respiratory failure due to a myocardial infarction. Transferred to care center on 05/15/2021. Patient nor her family desired any heroic measures due to her age and comfort measures were instituted. She expired on 05/19/2021. Prior to the vaccination, patient had been active, going to the YMCA to exercise 4 times weekly. She had no previous history of previous cardiac or respiratory problems.

short of breath; Total fatigue; This is a spontaneous report from a contactable consumer. An 89-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7533) via an unspecified route of administration in the left arm on 25Mar2021 at 12:00 (at the age of 89-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had a history of allergies to penicillin, codeine, vicodin, sulfur, erythromycin, oxybutalin and oxycodone. Concomitant medications included losartan potassium 50mg (MANUFACTURER UNKNOWN), amlodipine 10mg (MANUFACTURER UNKNOWN), sertraline HCL100mg (MANUFACTURER UNKNOWN), apixaban 2.5mg (ELIQUIS), cetirizine HCL 5mg (MANUFACTURER UNKNOWN), donepezil HCL 10mg (MANUFACTURER UNKNOWN), mirabegron ER 25mg (MYRBETRIG ER), atorvastatin 10 mg (MANUFACTURER UNKNOWN), sodium bicarbonate 650 mg (MANUFACTURER UNKNOWN), paracetamol 650 mg (TYLENOL), riboflavin 100mg (MANUFACTURER UNKNOWN) and cyanocobalamin 5000 mcg (B-12). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in the left arm on 04Mar2021 at 12:00 (at the age of 89-years-old) as a single dose for COVID-19 immunisation. 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 25Mar2021 at 16:00, the patient had experienced short period of short of breath which was about for 03 hours and total fatigue which was started 4 days ago and was continuing at the time of report. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken for the reported events. The clinical outcome of the events short of breath was resolved on 25Mar2021 at 19:00; while that of the total fatigue was not resolved at the time of this report. No follow-up attempts are needed. No further information expected

Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Pfizer series completed on 4/3/21). Patient was admitted to the hospital on 7/17/21 with 3 days of SOB, cough and fever and tested positive for SARS-CoV-2. On admission patient required HFNC however, developed rapidly escalating O2 requirements and was transitioned to BiPAP. She was initiated on corticosteroids, anticoagulation (LMWH), remdesivir and tocilizumab. Today patient is afebrile, still requiring supplemental O2 with HFNC 100/60 and being continued on remdesivir (day #3 of 5).

I got a blood blisters on my mouth and it is after 6 week I still have a spot on my lips where blood blister; I had loss of balance; I could not walk; I was short of breath/Trouble breathing; I had blotting stomach; I had pain in my head; I had trouble sleeping; I was very weak; I have a problem with my memory; I was so ill; I feared I would die I was so sick; This is a spontaneous report from a contactable consumer or other non hcp. A 89-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: ER8733) via an unspecified route of administration on 06Apr2021 at the age of (89-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced that she had loss of balance, could not walk, short of breath, blotting stomach and trouble breathing, pains in my head and trouble sleeping and she got a blood blisters on her mouth and it was after 6 week she still had a spot on her lips where blood blister was it was not painful, but she was very weak. She had a problem with her memory. She took Benadryl first and it did not really help after 3 or 4 weeks and then did not help she visited the emergency room for two times and later she went to doctor cabin for several times. This was how ill she was and eventually she had problems with Prednisone (Not clear and not clarified). She informed that she was so ill and did not take the second shot. The patient stated that she was very very ill, and she and her husband went to cemetery, a place where she could be buried because she feared she would die she was so sick, and her husband had a shot, and he was absolutely fine. The patient reported that there were people like who did not help and actually made her very ill maybe it was her age maybe it was her chemistry but it was definitely not for every single person. The patient finished taking drugs as she took them for a period of time (completed the course). She was not taking any drug and she was recovered, and she was doing better and her health was better. The patient took treatment for all the events. The outcome of the event the problem with her memory was not resolved whereas other events were resolved on an unknown date. Follow-up attempts are completed. No further information is expected.

Pt brought to ED after presenting with 1 week hx of cough, SOB and 2-3 day hx of nausea, decreased appetite, somnolence. Was found to be COVID positive (7/24) despite receiving Pfizer vaccines on 1/20 & 2/10. Was admitted for management of acute hypoxic respiratory failure secondary to COVID-19 PNA in which she received respiratory support via O2 and dexamethasone. Was ultimately discharged w/home O2 therapy and follow-up on 7/28.