Pfizer

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

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

Severe anaphylaxis shock, received 5 drug injections at vaccination site, transported to ER for observation. released later that evening.

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

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

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

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

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

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

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

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

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

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

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

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

DEATH-My Mother received her second Pfizer vaccine on Thursday, February 18, 2021 and died three days later on Sunday, February 21, 2021, after being admitted to the intensive care unit at Hospital. After developing an adverse reaction that started with nausea and then got progressively worse, including vomiting blood, Mom was rushed to the emergency room where she was tested for Covid-19 due to hospital policy (neg. result) and admitted to the intensive care unit. Mother died on Sunday, February 21, 2021. NOTE: Mother was doing well with her heart and renal conditions until she received the second dose of the Pfizer Covid-19 vaccine on February 18, 2021, directly or indirectly causing her death three days later on February 21, 2021. It is unfortunate that we are all advised (sometimes ill advised), particularly those with underlying conditions, to get vaccinated without the benefits of knowing when the vaccine can cause more harm than good. For obvious reasons, the approval of covid vaccines was rushed and thus the Pfizer and Moderna Studies are not thorough and lack in data to support an all call for everyone to get vaccinated in the name of herd immunity. Without the appropriate data, My Mother is DEAD! Sadly, there are probably more unreported deaths caused by the vaccine. While you have immunity from liability, you still have a moral obligation to collect data and advise accordingly. My goal is to save lives by sharing my mother?s personal experience and death after receiving the vaccine with everyone I know through every available resource. It is unconscionable that I have to shoulder the burden of getting the facts out about your vaccine so that individuals with underlying conditions can make a proper, informed decision about getting vaccinated. Sadly, I receive over 100 questions a day via social media from individuals inquiring about whether or not they or their loved ones should opt for the vaccine. I am not a medical professional?this is your job! Until you assume responsibility, I will continue advising anyone with heart and/or renal conditions to stay away from any and all covid vaccinations. Instead of the massive all call for vaccinations, we need further information and data from additional studies that will give more insight as to when the vaccine can cause more harm than good, as in My Mother?s case.

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

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

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

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.

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

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

pneumonia; She is coming up on 60 days now; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, at the age of 76-year-old, on Jan2021, as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was due to get the second dose on 18Feb2021 but was in the hospital with pneumonia and was unable to get the second dose. She is coming up on 60 days now. Outcome was unknown. Information about lot/ batch number has been requested

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.

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

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

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

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

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

Death R41.82 - Altered mental status N39.0 - Urinary tract infection N17.9 - Acute kidney injury (CMS/HCC) A41.9 - Sepsis (CMS/HCC)

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

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

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

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.

This 76 year old female received the 2nd Covid shot on 3/19/21 and died on 4/25/21. 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.

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

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

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

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

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

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

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

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

Patient received the first Pfizer immunization on 4-22-2021. She passed away on 4-30-2021. Her husband notified the pharmacy. Patient had been hospitalized for a period of time before the vaccination for 'bleeding internally' due to an unknown cause.

uncomfortable shooting sensation down her arm repeatedly throughout the day every day since first shot. 5/4 entered the hospital and diagnosed with Sepsis and MRSA. They cannot explain the source of this infection and cannot get it under control

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

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

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

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

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

I took the Pfizer vaccine in January and had a anaphylaxis reaction which I reported earlier. This is not about that but a week ago I began experiencing sharp pain in my thumbs when I tried to open a jar, pull up my pants, rub my hands together, flush the commode, etc. I have never had this kind of pain before. I looked on the internet to see what might help and noticed that the pain could possibly be a reaction to the Covid vaccine. Therefore, I am reporting it to you.

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

Patient had COVID in Sept. Minimal symptoms. Received 1st dose 1/18 without adverse reactions. Second dose on 2/8-had complaints of arm soreness several days after then appeared in usual state of health. On 2/14 @ 2 hours after having lunch, patient was found unresponsive with Respirations 60, pulse 130, PO 84%, blood pressure 105/68. Patient with lots of white foam coming out of mouth. Temperature to 101.3. Patient DNR B and family deferred transfer, wanted comfort measures only. Nursing received order for MSIR. Patient continued with temps in 99-100 range with tylenol suppositories. Patient passed on 2/16.

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.

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

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

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.

Patient was alert and oriented with no signs or symptoms of sickness prior to immunization for 2nd dose of Pfizer COVID19 vaccine. Temperature 98.7. Patient under hospice care and DNR status for wound care (coccyx). Patient has no recollection of first dose, but no adverse reactions to first dose per her caregivers. Patient did not appear to have any adverse reactions to the vaccine after the 15 minute observation period. About 1 hr after vaccine administration, patient was reported deceased. No signs of swelling or allergic reaction at site of injection.

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.

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

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

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

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.

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

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.

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

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.

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

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

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

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).

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

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.

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

PFIZER-BIONTECH COVID-19 VACCINE EUA. Patient received vaccination on 2/10/21. No adverse reactions reported following vaccination. Patient had unplanned weight loss x 1 month of 14.1% and 6 month loss of 20.8% according to nursing nutrition notes. HT: 60in Wt 122lb. Patient died on 2/12/21.

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

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

could not walk or eat; could not walk or eat; sore arm; doctor took a test and the caller has antibodies and they are there but not very strong; anaphylactic reaction; excruciating pain in the body; felt like if her internal organ were shutting dow; was so weak her husband fed her and made sure she was drinking; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 08Mar2021 15:30 (3:30 PM) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included hashimottos (reported as hoshimottos) Diagnosed 35 years ago, hypermobile Diagnosed 20 years ago, and disorder nomia Diagnosed 25 years ago; all unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID); diazepam (VALIUM); and levothyroxine (LEVOTHYROXINE); all taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 on 15Feb2021 for covid-19 immunization first dose at the left arm and experienced immobile for a day, cannot walk, weakness and sore arm. The patient was to know if there is going to be a booster for the Pfizer covid vaccine. The patient stated she received the Pfizer covid vaccine both doses and she is calling to report the reaction she had with the first and second dose to help other patients, she said she was close to death after the second dose. In the middle of the night she was awaken due to excruciating pain in the body, like truck ran over her. The patient heard that someone had same reaction who was in the hospital, with similar symptoms to covid. She said she felt like if her internal organ were shutting down. She does not do well with the antibiotic, and does not go to the doctors. She could not walk or eat after the second dose. She said she has hashimoto dysautonomia hypermobility. she said she thinks she might have had anaphylactic reaction. The patient added that she has lived through it and her experience has been very unusual. The caller has underlying conditions that may have caused this event, she received the second dose on 08Mar2021, it was a horrible experience but since she is still alive she would want to report it. The caller does have strange reactions to chemicals and she typically goes to naturopaths and holistic doctors because of this. The caller also has multiple autoimmune disorders and feels like that may have played a part in this reaction. It was added that further added that she received her second dose 08Mar2021 at 3:30pm and had a little bit of a sore arm, she was thinking positive thoughts about all of this because she never gets vaccines. At 2:00am on 09Mar2021 the caller was awaken in excruciating pain, every surgery she has had or accident manifests in the greatest pain. The pain was excruciating the caller took over the counter pain medicine and diclofenac and it didn't help. The caller is unsure of what she took, she may be making this up. The caller felt like she was dying, she felt like her internal organs were shutting down, it happened all week. The caller was so weak her husband fed her and made sure she was drinking. The caller thinks she would die if she had to have a booster shot of this vaccine. The caller has never had anaphylactic shock, could this have been anaphylactic shock? All of the pain from a surgery all occurred at once and her entire body was wrecking, in horrible pain, that she does not think heroin could have taken care of. After the second vaccine she was literally so weak that she felt like all of her vital organs were shutting down and it lasted for 6 days, like she got hit by a truck, like had beat her up. The caller knows that there are new found reactions with (Company name) and they stopped thousands of doses because of it, she saw this in the news today. The patient wanted to make note that she has underlying autoimmune diseases, she is unsure if there is a correlation between this and her reaction. The caller was changing from her thyroid medicine and her thyroid went very high with the generic brand so she was swapped to Synthroid in the middle of this. The caller was on levothyroxine and it wasn't working, her thyroid was sky high (Unknown lot number and expiration date Feb2022). The caller was going through all of these changes as well when she received the vaccine. The caller's doctor took a test and the caller has antibodies and they are there but not very strong. The caller doesn't want to be spreading something because she is feeling healthy and fine today. The outcome of the events was unknown.

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.

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

This 77 year old female received the Covid shot on 4/1/21 and went to the ED on 4/11/21 and admitted on 4/12/21 and again to the ED on 4/24/21 with the below listed diagnoses and died on 5/9/21. J18.9 - Pneumonia, unspecified organism

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

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

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

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

Patient presented to the ED and was subsequently hospitalized for Severe sepsis with septic shock within 6 weeks of receiving COVID vaccination.

case hospitalized due to COVID. Case in the ICU with pneumonia and ARDS and currently on a ventilator.

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

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

had anaphylactic reaction/throat and mouth swelled so much dentures pushed out of the top; This is a spontaneous report from a contactable nurse. A 77-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: ER8734, expiry date unknown), intramuscular, administered in the left arm on 02Apr2021, dose 2, single for COVID-19 immunization. Medical history included coronary artery disease (CAD), hypertension (HTN), arthritis, atrial fibrillation, diabetes mellitus (DM), breast cancer which was in remission all from an unknown date and unknown if ongoing. Concomitant medication included isophane insulin (NPH INSULIN); potassium (manufacturer unknown); sertraline (manufacturer unknown); levothyroxine (manufacturer unknown); acetylsalicylic acid (BABY ASPIRIN); calcium (manufacturer unknown); trazodone (manufacturer unknown); dicyclomine (manufacturer unknown); famotidine (PEPCID); insulin human injection, isophane (NOVOLIN N); carvedilol (manufacturer unknown); magnesium (manufacturer unknown); vitamin b complex (SUPER B COMPLEX [VITAMIN B COMPLEX]), all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfonamide and codeine and experienced allergy. The patient previously received the first dose of bnt162b2 (lot number: EN6208), intramuscular on 12Mar2021 at 07:30 in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Apr2021, seven days post the second dose of the Pfizer vaccine at 19:30, the patient had anaphylactic reaction to shrimp in which she never had this reaction ever before, eating shrimp all the time, eating other items in the dinner all the time, throat and mouth swelled so much dentures pushed out of the top. The patient's husband called EMS and the patient was given Benadryl x 2, epi x2, shots x2, was intubated and woke up two days later in ICU. The patient's allergy and blood tests were negative for any possible food allergies that she had consumed on that day. The patient's doctor stated this event could have been absolutely related to the vaccine. The event resulted in a visit to the emergency room/department or urgent care and was hospitalized for 10 days. The patient received epinephrine, magnesium, antihistamine and steroids as treatment for the events. The patient was intubated and placed on a ventilator. The patient has not recovered from the events. The events were considered as a life-threatening illness (immediate risk of death from the event).; Sender's Comments: Based on the information currently available and the known product safety profile, a possible contributory role of suspect product BNT162B2 to the reported anaphylactic reaction cannot be completely excluded. This case will be reassessed upon receipt of additional information.

COVID-19 infection resulting in severe ARDS requiring intubation and ultimately death from COVID-19 infection.

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

A little sore arm; She then developed pneumonia and a urinary infection; She then developed pneumonia and a urinary infection; This is a spontaneous report from a contactable consumer or other non-health care professional. A 77-year-old female patient received bNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number& Expiry date not reported) via unspecified route of administration in arm on 03Jun2021 (at age of 77-year-old) as dose 1, single for COVID-19 Immunization. Patient medical history includes Memory Loss, Breast Cancer, Allergic to Sulfa Medication, Flexeril, Allergic to Clams and Shellfish, Pneumonia, Urinary infection. Patient concomitant medications were not reported. Caller reporting on behalf of his wife who received her first Covid 19 vaccine on 03Jun2021 and she developed pneumonia and a urinary infection. She was prescribed amoxicillin for her infection. The caller wanted to know how the antibiotic will affect his wife. He reports her second Covid 19 vaccine is past due by 2 weeks. He reports his wife gets pneumonia every year and it is not from the Covid 19 vaccine. She received her first Covid 19 vaccine on 03Jun2021 and was due for the second Covid 19 vaccine on 24Jun2021. This is discrepant from the above information that his wife is past due by 2 weeks but is documented as provided by the caller. She will not be able to get the second Covid 19 vaccine until the first week in Jul2021. She waited because she was prescribed a Z-pack for her pneumonia started on 29Jun2021.She developed a urinary infection, she has a history of getting urinary infections too. The doctor also wanted a chest x-ray to make sure that her pneumonia was gone. The Amoxicillin will double check that his wife has no more pneumonia and will clear up her urinary infection. She was hospitalized in 2019 because of a urinary infection. The doctor prescribed Amoxicillin and she cannot wait any longer to get her second Covid 19 vaccine. She must get her second Covid 19 vaccine before time runs out. He reports none of this has to do with the Covid 19 vaccine. These are problems that his wife has had before.Upon follow up when probing for information regarding the sore arm he and his wife experienced he reports the sore arm was minor, it was just where the injection was in jun2021. His wife had breast cancer and can only get injections in one of her arms. It was a little soreness, nothing, barely noticeable. He and his wife did exactly what the pharmacist said, they took a lot of fluids, drank Gatorade for electrolytes. He reports his wife is sleeping right now because she was at the doctor's office this morning. He reports his wife's doctor is being thorough before his wife gets the second Covid 19 vaccine. He is supposed to call the pharmacy to schedule his wife's second Covid 19 vaccine on 03Jul2021. The pharmacist told him not to cancel his wife original appointment because it would remove her from the system. He's will call on 03Jul2021 and hopefully his wife will be able to get her second dose on 05Jul2021 or 06Jul2021. At that time, she'll almost be off the Amoxicillin. He is asking what the effectiveness rate is of receiving the Covid 19 vaccine while on an antibiotic.The pharmacist told him the effectiveness is diminished for people who have taken an antibiotic. He believes the first Covid 19 vaccine provides 70% effectiveness while the second Covid 19 vaccine provides 95% effectiveness. His sister-in-law has titanium plates in her back and must take an antibiotic for the rest of her life and she received the Covid 19 vaccine. Advised in response to caller to discuss with Health care professional about the final decision about receiving the second dose to discuss the risks and benefits of the administration of the vaccine and the HCP is most familiar with the health history of his wife. Pfizer is unable to make treatment recommendations for individual patients. Patient underwent lab test and procedures include Chest X-ray result was it showed nothing, no pneumonia; SARS-CoV-2 test was negative; Urine analysis result was unknown; all tests done on Jun2021. The outcome of event was unknown. Follow up (29Jun2021): This is a follow up spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported for a 77-year-old female patient (reporter's wife) that: New information include medical history, schedule of second dose, Lab test, event little sore arm, visit of physician office. No further information is provided or obtained.Information on lot/batch number has been requested.

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

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

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.

At approximately 930am I arrived at Memory Care. I met with the director of the facility and she directed me to where my team would be setting up. My team consisted of (technician), (nurse) and I. As we were setting up, the director asked how she can help. I explained to her that we would need a designated area for patients to be monitored after vaccination for 15 minutes and maybe even longer . I also explained that we would need one of her staff monitoring while we vaccinate. She agreed, and proceeded to designate her staff and the cafeteria area, facing the vaccination station,the monitoring station. Throughout the day, nurse and I were both vaccinating,while the staff of the facility would monitor the vaccinated patients. I would also stop occasionally to mix the vaccine and check the temperature of the aero safe. At approximately 12:50pm, the director rushed in and stated that a patient is not responding, and that she had been vaccinated. At that point, I grabbed epipens and a thermometer and I also instructed nurse to grab an Epipen and come with me. We followed the director to pt's room. Once we got to the room, the patient was in bed and there were 4 staff members standing bedside and one of them turned and stated the patient has passed. At that point I asked the staff how long ago did the patient get the vaccine, they stated about 30 minutes ago. They also stated that the patient was a hospice patient and that the patient had declined, and was rapidly detiorating and had not eaten or drank anything all day . They also stated that the patient had been monitored for 15 minutes post vaccination. I then left the room and grabbed the patients COVID Vaccine intake consent form. I looked at the answered questionaire and all the responses were circled NO. Patient had a temp of 96.5 at the time of vaccination.The vaccine administration information for Immunizer Section was filled out by Nurse. I then proceeded to ask the director once again if there were staff that was monitoring her for 15 minutes, the director stated they had staff monitoring her. She also stated the Hospice nurse has to announce her death, so they waited for the Hospice Nurse to come. I then called Corporate and explained the situation. After speaking to corporate, I also asked nurse, if she remembered the patient. She stated that she did and at the time of the vaccination the patient was not alert, there were two staff members with the patient. She was non oriented and she kept closing her eyes. At that point, Nurse stated that she asked the two staff members with her if this is how she usually is and if its ok to vaccinate her. Both Staff members stated that it its ok,this is how she is. The Nurse then proceeded to vaccinate. At approximately 3:10pm, as I was leaving I spoke to the director, and one of her Staff members. Staff that the patient has actually not eaten/ or drank anything for the past several days, including today(01/18/21). Staff also stated that on Friday, Jan 15th,2021, they had informed the family that the patient was rapidly detiorating. Staff also stated that the family knowingly gave the consent to vaccinate her. She also stated that the hospice Nurse believes that the death was primarily caused by her detiorating state. She also stated that the hospice Nurse informed that the death was not due to the Vaccine. Per Lead Pharmacist at the clinic.

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

Patient sent to hospital 1/2 and 1/5. Returned both times to nursing home covid unit without a hospital admission. Resident had been diagnosed with COVID later in the day on 12/30, when routine testing PCR results returned to facility, after resident had already had her first covid vaccination on 12/30/20 in the morning. Resident continued decline, was again sent to hospital on 1/24/21, and expired in hospital 1/25/21.

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.

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

Body aches, low gr. temp. aches into her buttocks area down back of post. thighs. She did have Covid infection in Sept 2020. Meds admin - NaCl 0.9% I.V. bolus. 500 ml. Tyl. + Hydrocodone 650/25 - Labs - UA. lactic acid, SARS antigen, BMP, CBC, CXR - revealed pneumonia - F/U with family practice on Monday. In addition to above - numbness from waist down to toes, loss of bowel + bladder. T-102.F. Unable to walk - this lasted for 17 hrs.

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.

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

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

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

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.

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.

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

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

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

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

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

Deceased Narrative: This was a 77 yo F with h/o HFpEF, afib (warfarin), COPD, obesity hypoventilation syndrome, OSA on BiPAP, T2DM, RA, L-sided follicular bronchitis and newly diagnosed probably malignant pulmonary process. Patient was admitted to facility 9/26-10/15 for acute on chronic hypercarbic respiratory failure with persistent O2 requirement despite treatment for CAP, COPD and CHF exacerbation. Patient then underwent high dose steroid taper per Rheum. Patient presented an overall poor state of health and was at high risk of complications with any procedures and was not a candidate for systemic therapy for a malignancy based on functional status. Patient was accepting of terminal diagnosis and transitioned to comfort measures at home.

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

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

Resident found unresponsive found at 1545, CPR done, EMS responded and resident Pronounced Dead at 1615

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

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

ADR began 6 days after the second dose. Caller states she spoke to PMD when she developed the diarrhea with blood beginning about 6 days after 2nd dose of vaccine. The MD recommended Urgent care , but urgent care recommended ED and patient went to the hospital. Went to ED Saw ED MD Diagnosed with diverticulitis and treated with IV fluids in ED and 10 day course of Flagyl that she began on 2/27 . CT scan incidental finding: Pneumonia Diverticulitis s/sx - mainly diarrhea with blood but perhaps slight Abd tenderness or cramps all of which abated while on Flagyl, but recurred after Flaygl stopped and then persisted until yesterday. She received trimethopril/sulfamethathoxazole for the pneumonia. which she took concurrently with the Flagyl Patient was not admitted to hospital. S/sx cleared completely 3/30. Patient had Diarrhea so bad she thought it was C.Diff, but tested negative for this - results just came in today. Note: Unable to obtain patient's date of birth. Patient is 78 years old.

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

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

Death Narrative: Death on 01/25/2021. 2nd dose administered 19 days prior to severe event. Patient had diagnosis of malignant pulmonary process with a terminal prognosis. There are no indications that death was related to the vaccine.

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.

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

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

Pneumonia after getting the COVID Vaccine; Pneumonia was related to MRSA; Very weak; mild fever; This is spontaneous report received from a contactable consumer (patient's husband). A 78-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 78-years-old, administered in arm on 25Feb2021 15:45 (Lot Number: EN6202) as single dose for COVID-19 immunization. Medical history included diabetes mellitus from 2011 (Verbatim: Diabetic; Diagnosed 10 years ago), rheumatoid arthritis from 1995 (Verbatim: Rheumatoid arthritis; Diagnosed in 1995), cardiac failure congestive from Oct2020 (Verbatim: Congestive Heart Failure), adrenal insufficiency from 1990 (Verbatim: Adrenal insufficiency; Diagnosed in probably 1990), atrial fibrillation from 2017 (Verbatim: Atrial fibrillation; Diagnosed 4 years ago). Concomitant medication included unspecified medications ("she takes lots of medications. Too long of list she probably takes 15 different medications, reporter chose not to provide them). No-other vaccines were given at the same time. She gets the flu vaccine every year, shingles vaccines, pneumonia vaccines every year but, has no idea where they were manufactured. Confirmed she did not get the listed vaccines at the same time she got the COVID Vaccine. The patient's husband and the patient (his wife) both received their 1st COVID shot on the 25Feb2021 and was scheduled for 3 weeks later. He got his COVID on the 18Mar2021. The patient got Pneumonia and was admitted to the hospital but he does not know the exact time the Pneumonia started. It developed over a period of several day started with a mild fever (in Mar2021) and after the 2nd or 3rd day her fever spiked and that's when she was admitted to the hospital. He reports his wife went into the hospital with Pneumonia on 18Mar2021, the day she was supposed to get the 2nd shot. It was also reported that Pneumonia was related to MRSA. She laid up in the hospital for 2 weeks, the weakness ("very weak") may have happened in the hospital or a few days before, date was confirmed to be on 15Mar2021. The event "pneumonia" was totally unrelated to COVID and now she is in a nursing home, she went in on 26Mar2021. She probably won't be able to have the 2nd shot for a couple of weeks. She was in there for a couple of weeks and still quarantined. He wanted to know will the fact that she is not getting the 2nd shot at the 3-week interval reduce the efficacy of the vaccine since she is getting the 2nd dose late. Does it make a difference with the effectiveness of the vaccine if she's going take the 2nd dose 3-4 weeks or even a month and a half rather than the usual 21 days interval? No treatment before going to the hospital other than calling the doctor and the doctor saying take her to the hospital (not reported if patient received treatment during hospital stay). No treatment done over the weekend, while she was in the nursing home. The adverse event pneumonia required a visit to Emergency Room. The patient was hospitalized from 18Mar2021 to 26Mar2021. Investigations included had a lot of blood work done, a CT scan, an X-ray on unspecified dates. He does not have any of the results but, the physicians have them. The outcome of the event mild fever was unknown, for very weak was not recovered while for the rest of the events was recovered on 26Mar2021.

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

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

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

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

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

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

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

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

This 78 year old white female received the Covid shot on 1/29/21 and went to the ED and admitted on 4/7/21 with the following diagnoses listed below. U07.1 - COVID-19 J12.82 - Pneumonia due to Coronavirus disease 2019 J18.9 - Pneumonia R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC)

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

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

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

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

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

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

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

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

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.

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

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.

Patients daughter called on 6/29/21 to inform pharmacy that patient had passed away. It is unclear what patient passed away from as patients family did not leave that information with the floater pharmacist who was working.

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

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

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

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

COVID-19 Breakthrough disease which possibly resulted in death. Patient was fully vaccinated and was COVID-19 positive at time of death. Patient had symptom of cough that began 7/17/2021; the patient died on 07/20/2021. Patient tested positive for COVID-19 on 7/20/2021 at the long-term care facility at which they were a resident. I do not have death certificate details available at this time.

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

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.

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

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

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

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.

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

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

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

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

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

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

Husband returned for second dose of COVID-19 vaccine and reported that wife, expired the day after her first dose of the COVID vaccine. Medical team did not feel that there was a correlation so we were not notified prior to that date

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

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

Tiredness and fever began on 3/1. On 3/2/21, patient had phelgm in her lungs but unable to cough up. She was admitted to the hospital on 3/4/21 and stayed for 5 days. Patient was at the Pali Momi Medical Center in Aiea, HI.

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

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.

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

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

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

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

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

Pneumonia; got Covid; doesn't have her appetite back; still kind of shaky/was trembling and shaking; lives with her niece and she found her in between china cabinet and fireplace and asked her how long she been there and she didn't know/going to the bathroom on herself and she doesn't recall that; This is a spontaneous report from a contactable consumer (reported for herself). This 79-year-old female patient received her first dose of the BNT162B2 (Pfizer covid vaccine, Lot number: ER2613 expiry date: unknown) via an unspecified route at left arm as a single dose on 23Mar2021 11:00, for Covid-19 immunization. Medical history included diabetic, cholesterol, acid reflux; had a reaction to tetramycin: she had shortness of breath, sweating, and light headed-ness, 30 years prior to this report. She stated that it was a form of penicillin and they didn't have penicillin so they gave her something else. Concomitant medications included metformin(METFORMIN) for diabetic, fexofenadine hydrochloride (ALLEGRA) and ibandronate sodium (BONIVA). It was reported that she skipped Boniva, that she usually would take at the end of the month. On 25Mar2021, two days after first dose, she got covid and pneumonia . She visited emergency room and was admitted in the hospital from 26Mar2021 till 05Apr2021. The patient did not have her appetite back, felt still kind of shaky, and was trembling and shaking. She did not remember what happened on the 24Mar2021 and 25Mar2021. It was stated that she was improving but she was not back to par. she was not trembling. She stated that she was not fully recovered. She was scheduled for her second dose in 2 weeks on 13Apr2021. It was stated that she had got a list of concomitant medications she was taking (unspecified names) and she did not think any of them would have interacted with this and she was taking them way before she got the Covid shot, also stated that she did not think she had bad underlying issues. The patient had her blood sugar checked and was given her insulin because of Covid and something else. She did not receive any additional vaccines on same date of the Pfizer Suspect or prior vaccinations (within 4 weeks). The patient did not have any Antipyretic (around the date(s) of Vaccination). The patient was recovering from the event of Pneumonia. The outcome of the events of doesn't have her appetite back and shaky/was trembling and shaking was not recovered, however the outcome of the events of Covid and did not remember what happened on the 24Mar2021 and 25Mar2021 was unknown. No further information was provided.

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

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.

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.

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

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

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

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

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

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

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

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

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

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

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.

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

Patient 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).

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

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.

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

Two hours after receiving her 2nd dose of the Pfizer Covid Vaccine, patient had a Stroke (large brain bleed). She never recovered and passed away May 18th, 2021

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

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

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

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

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

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

No immediate symptoms. No symptoms ever reported. Patient was found dead in her home on 1/25/2021 and last seen on 1/24/2021. Neighbor called for welfare check because they had not seen her and she had not checked mailbox. No evidence of foul play.

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

patient contracted COVID; patient contracted COVID; This is a spontaneous report from a contactable consumer. A non-pregnant 80-year-old female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, the first dose in 2020 and the second dose on 22Dec2020 11:00, both at a single dose for covid-19 immunization. Medical history included heart, diabetes, obesity. There were no concomitant medications. The patient did not have covid prior to vaccination. The patient contracted COVID on 04Jan2021 11:00. The patient was hospitalized for COVID-19 for 8 days. The patient underwent lab tests and procedures which included: Nasal Swab: negative on 24Dec2020, negative on 28Dec2020, negative on 31Dec2020, positive on 04Jan2021. Unspecified therapeutic measures were taken as a result of the event. The outcome of patient contracted COVID was fatal. The patient died on 12Jan2021. It was unknown if an autopsy was performed. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Reported Cause(s) of Death: patient contracted COVID

Day after receiving the vaccine, the patient complained of abdominal pain which worsened over the day. She went to the ED and was hospitalized. Abdominal pain complaints increased and continued, she decompensated rapidly, was intubated and subsequently died 3 days later. Imaging results showed, progressive ovarian cancer in the bowels. Blood culture revealed that she had E.Coli in her blood. It is thought that this is NOT related to the vaccine.

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

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

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

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

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.

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

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

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.

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

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

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

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

bleeding from ileostomy; abdominal pain; This is a spontaneous report from a non-contactable pharmacist. An 80-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), intramuscular on 28Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took Iodine, Levaquin and Morphine and experienced allergies. It was unknown if the patient received other vaccines in four weeks. The patient experienced abdominal pain and bleeding from ileostomy on 01Mar2021 at 11:00PM. The events resulted in emergency room/department or urgent care and hospitalization. The patient had no COVID prior vaccination and had not tested post vaccination. The outcome of the events was unknown. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Sender's Comments: Based on the information available the events abdominal pain and bleeding from ileostomy are attributed to intercurrent medical conditions that were not related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

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

- 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.

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Patient was diagnosed with pneumonia.

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

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

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

death - Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung - Acute kidney failure, unspecified

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

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

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

Resident expired on 1/23/21 . Resident receiving care under hospice ,diagnosis Acute Myeloid Leukemia.

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

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.

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.

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

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

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

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

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.

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

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

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

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

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

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

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.

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

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

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

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

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

Patient had several ED visits and was admitted to the hospital, all within 6 weeks of receiving COVID vaccination. ED visits 3/5/21, 3/18/21, and admissions on 3/22/21.

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

My mother, was found deceased on March 19, 2021. Last seen and spoke to on March 18, 2021 around noon or before. After first injections, Pt reported being extremely tired around day 4 and laid down for a nap in the afternoon and woke up the next day in the morning. On the day she was found, it appears she had taken a nap on the couch and never woke up from the nap. This occurred within 10 days after the shot. Possible 9 days if she passed on the 18th. She was found deceased on 3/19/2021 after she didn't answer he apartment door for her meal being delivered.

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

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

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

Lab test positive for detection of COVID-19 virus Pneumonia of left lower lobe due to infectious organism

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

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

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.

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.

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

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

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

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

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

Patient went to bed around 11pm on Saturday PM and sometime between then and 1:30am on Sunday morning got up and went into the living room without waking up her husband (which is normal). At 1:30am, the husband got up to use the restroom and she was out of bed then, but the husband did not know if she was having any problems at this time. When he got up at 7:45am, she was in the recliner and did not move or anything, which is normal for her. At 8:45am, the husband went back into the living room and tried to wake his wife and that is when he noticed there was no pulse and he called 9-1-1 at this time. EMS got on scene and did CPR for 30 mins and she was pronounced dead at 9:21am.

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

Per EMS report, within 15-minutes of vaccination, patient underwent an anaphylactic reaction. Patient's care was managed on site.

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

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

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.

Patient was hospitalized, presenting to the ED with confusion/encephalopathy. She was also found during her hospitalization to have hypoglycemia, CAP, UTI, and liver cirrhosis with elevated LFTs/ammonia. She was given antibiotics and lactulose to manage. Patient recovered and was later discharged

Diarrhea next day, Sunday night around 7 pm. Bleeding on her pad like menstration. All better next day, except minor pain on lower stomach.

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

My mom received the Pfizer Covid 19 vaccine on 1/4/21. On 1/12/21 I received a call from the nursing home that my mom had stopped eating and drinking and that she had nothing to eat or drink for 3 days. I asked them why they didn't call me sooner but they did not have an answer. I was told to come in because she was very lethargic and possible dehydrated. They tested her for Covid the morning of 1/12/21 and she tested negative. I went into see my mom and she was barely conscious. They gave her fluids intravenously but it had no positive affect on her condition. On 1/14/21 she tested positive for covid and was moved to their covid unit. I called in Hospice comfort care on 1/15/21. My. mom died on 1/17/21.

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

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

Patient had COVID pneumonia in January 2021. Readmitted 2/10 for nausea/vomiting found to be in DKA. Treated with IV insulin, fluids, pressors and admitted to ICU. DKA resolved but continued to have ongoing nausea and dysphagia. EGD showed possible candidiasis, GI symptoms started to improve and was discharged home 2/24 with O2, life care, home health care. Patient recorded deceased 02/26/2021.

1/21/2021 During Covid 19 outbreak on the unit, resident contracted the virus. 1/21 MD updated on increased weakness, twitching, fatigue noted today. 2 rapid covid-19 tests done today, both negative. new orders cbc with diff, BMP, d. dimer stat and swab for covid and Influenza. 1/21-Covid and Influenza swab results received. PCR-Influenza negative, covid-19 positive. Palliative care updated. 1/21-Labs drawn cbc, BMP, d. dimer Results WNL. Temp 101.2 and Occ dry cough. 1/22 Palliative MD and APRN visited. Family preference for no hospitalizations, no IV's and do not intubate. DNR. Admitted to Hospice services on 1/25. 1/21-1/29. Symptomatic with lethergy, occ cough, off and on temp and began refusing meals and meds at times. 1/31 periods of apnea. 2/1 precautions ended for Covid 19. Continued with Hospice care and with ongoing refusal of meals, condition declining and comfort maintained. Meds slowly discontinued. Expired at facility on 2/18/2021.

Patient has nausea, vomiting, severe headache and severely increased blood pressure. She reported to the ER where it was determined she had had a stroke.

she passed away on 19Feb as she had a HGB of 5; O2 sats were in 70s; she had a HGB of 5; on the same side the patient hand started swelling; lymphedema from L breast; swelling all over; This is a spontaneous report from a contactable consumer reporting on behalf of the mother. An 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Feb2021 at 13:45, at single dose, in left arm, for COVID-19 immunization. No other vaccine was given in four weeks. Medical history included chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). Known allergies: none. The patient had no COVID prior vaccination and was not tested after vaccination. Concomitant medications were not reported, however, the patient received other medications in two weeks. On 05Feb2021 at 09:00, on the same side the patient hand started swelling and doctor gave her some furosemide (LASIX). One week from vaccination she started having lymphedema from L breast and started noticeably swelling all over. On 18Feb2021 she was taken to the hospital as O2 sats were in 70s. She passed away on 19Feb2021 as she had a HGB of 5. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization for 1 day. No treatment was received. No autopsy was performed. Low oxygen saturation, hand swelling, lymphedema from L breast and swelling all over final outcome was unknown. Information on Lot/Batch number has been requested.; Reported Cause(s) of Death: she passed away on 19Feb as she had a HGB of 5; she had a HGB of 5

Pain for 4 or 5 days in left leg (that leg also has varicose veins), some swelling and tender to the touch . Fifth day became raised and warm to the touch, so went to Urgent Care Diagnosis: Occlusive and nonocclusive thrombus within a superficial vein underlying the region of concern

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.

blood clots right nostril; pain/discomfort right side at waistline going toward back; pain/discomfort right side at waistline going toward back; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Lot Number: EL9581), as single dose in left arm on 06Feb2021 10:30 for COVID-19 immunisation, administered at hospital. Medical history included artificial mitral valve. No known allergies. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received concomitant medications in two weeks but were not reported. No other vaccine in four weeks. The patient received the 1st dose of bnt162b2 (BNT162B2), on ana unknown date for COVID-19 immunisation and experienced pulsatile tinnitus right ear. The patient experienced blood clots right nostril, pain/discomfort right side at waistline going toward back on 16Feb2021. The patient was hospitalized for blood clots right nostril. She went to Dr. for tinnitus, had MRI and CAT scan in 2021. All tests were negative. She received no treatment. COVID was not tested post vaccination. Right side got better after several days in 2021. Blood clots in nose lasted one morning and recovered on 06Feb2021.

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 received vaccination at 1430 hrs on April 2. Died in her sleep that night...sometime between 2200 hrs April 2 and 0600 hrs April 3.

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

suffered from atrial fibrillation and she has not had atrial fibrillation in over 13 months; suffered from atrial fibrillation and she has not had atrial fibrillation in over 13 months; This is a spontaneous report from a contactable consumer. A 82-year-old female patient (reporter's mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration on 12Mar2021 at the age of 82-years-old as single dose for COVID-19 immunisation. The patient took the shot at the regional vaccination center and she had an appointment of course set up by her doctor, but they don't have any specific name. The patient's medical history included blood pressure and atrial fibrillation. Concomitant medication included metoprolol taken for an unspecified indication, start and stop date were not reported. The reporter stated that his/her mother experienced a reaction after having the shot. She took the shot on 12Mar2021 and suffered from atrial fibrillation and she has not had atrial fibrillation in over 13 months and once she took the shot on the very next day (13Mar2021) she had atrial fibrillation which lasted about two and a half day. They went to her heart doctor and they checked her out and they said that other people that had taken the vaccine had experience the same thing so, the reporter was calling to see if that was something Pfizer has heard before or not. It was reported that the patient was scheduled to take the second shot this coming Friday and after speaking with her doctor they indicated to go ahead and take the second shot but again the reporter wanted to report this because the reporter knew the company was keeping a record of this information. It was reported that the patient was about 5 feet 7 inches and probably 140 pounds. The outcome of the event was recovered on 15Mar2021.

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.

Heart stopped suddenly after 18 days probably due to presence of Potassium Chloride in the injection. Outcome DEATH within 2 hours thereof as medics unable to regain consciousness after CPR.

was fine until Thursday evening 4/22/2021. Started feeling body aches and restless. Friday morniing 4/23/2021. She woke up and went to the bathroom. Go out and fell and went into cardiac arrest. #12: GAD, Fibromyalgia, migraine, ventral hernia, hypothyroid, hypercholesterolemia, neuropathy, Hx of Covid-19

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.

Fatigue, water retention - in feet/legs and lungs resulting in A-fib. These symptoms continued for weeks. After seeing PCP on March22, 2021, I began taking lasix and potassium for swelling. After seeing cardiologist on April 1, 2021, I began taking Eliquis, entresto and metoprolol. My heart is now back in sinus rhythm. The "pumpability" of the heart in March 30, 2021 echocardiogram registered at 20 (should be 50 or above). A follow up pet scan on April 16, 2021 show it improved to 35.

right leg: sore, pinkish, swelling, puffiness, sore walking and climbing steps dr. visit, on March, sent to ER for ultrasound, admitted to ER for visit and tests Deep Vein Thrombosis in right leg and superficial blood clots in right leg diagnosed eliquis prescribed for 3 months

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Patient was diagnosed with DVT of left lower extremity and abdominal hematoma.

Raging High Blood Pressures - Hospitalized and placed on Heart & blood Pressures 2nd Hospitalization 3/3/21 High Blood Pressure and Mini Stroke It has been 2 months and still have fluctating blood pressures

This 82 year old female received the Covid shot on 2/16/21 and went to the ED on 5/3/21 and was admitted on 5/3/21 with the following diagnoses listed below. SIRS (systemic inflammatory response syndrome)

Patient admitted on 5/5/21 for suspected acute ischemic CVA after presenting with altered speech for a day (last known well on 5/4/21 PM). No CT evidence of an acute intracranial process. Her pacemaker precluded MRI evaluation. Pacer interrogated on 5/6/21 with AT/AF burden <0.1%. She was seen in consultation by neurology. Evaluation and clinical deficits were suggestive of acute ischemic CVA. Risk factors for CVA include age, HTN, Afib. Patient recently received her first COVID-19 vaccine (Pfizer) on 4/26/21. Patient?s symptoms improving with antiplatelet and statin therapies along with blood pressure management. Per Neurology consult, possible etiologies include cardioembolic versus atheroembolic versus thrombotic versus inflammatory related to recent COVID-19 vaccine. The neurologist specifically stated that ?The COVID vaccine was temporally close to this event. I have seen transient CNS inflammation from the vaccine--probability low but still possibility.?

J18.9 - Pneumonia, unspecified organism R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction

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.

J18.9 - Pneumonia, unspecified organism D69.6 - Thrombocytopenia, unspecified R56.9 - Unspecified convulsions

She received her first dose on 2/6/21 around 11:30 a.m. On 2/7/21 she was a bit tired and her arm was a little sore. Sometime after the afternoon of 2/7/21 and the morning of 2/8/21 she was found unconscious and unresponsive on the floor. As her dinner from the evening of 2/7/21 was still on the table unfinished and she was fully dressed we assume that whatever caused her to end up on the floor unconscious happened on 2/7/21 She was taken to the emergency room and it was determined that she was not going to survive. She never regained consciousness and was having seizures all the way to the hospital in the back of the ambulance. She was made comfortable and passed on 2/11/21.

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.

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

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

Patient was admitted to referring hospital on 5/24/21 for tongue swelling . Per chart review, patient's husband reported spontaneous bruising of right arm and swelling after received 2nd dose of COVID vaccine, which eventually came down. Repeat swelling occurred about 2 weeks prior to index admission, and was started on antibiotic for suspected cellulitis (cephalexin). Also reports of spontaneous brusing, as well as one episode of bleeding/oozing. At the ED, blood work revealed low hemoglobin (5.6) and PT 14.3, PTT >120. She was nasally intubated for airway protection. She was transferred to our institution on 5/25/21 for hematology work up and evaluation. Hematology evaluation is highly suspicious for acquired factor VIII inhibitor, and later confirmed with laboratory tests. She received recombinant factor VIII replacement (Obizur) as well as Emicizumab, as well as rituxamab for treatment acquired factor VIII inhibitor. Patient current still hospitalized.

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.

The morning after I received the vaccine, I started feeling tired and my arm was quite sore. The following day, I had a fever of probably 100. I had chills and my heart rate and blood pressure went up. Since I have A-Fib, it was irregular. After several hours, my HR went back to normal and that is when I called my Cardiologist NP. She said that she thinks it's related to the fever I had. The next day, I felt a tad better, but fatigue and generally not feeling well lasted a few days. I feel that it took about a week before I felt normal again. About two months later, I was making plans to go out of town and I became very ill. I started having chills, fever, nausea and extreme fatigue. I may have taken some Tylenol. I was drinking a lot of water because I did not have an appetite. A couple days later I felt a little better so I did not contact my doctor, but I did go to an urgent care (05/22/2021) and had a COVID test. The test came back negative and I felt better two days later. On Monday, I started feeling bad again and I contacted my PCP, and I went to see him on Tuesday. He ran some blood tests and another COVID test, which came back negative. The fatigue just stayed around for quite some time. He monitored my sodium and chloride and they were both low so the doctor wanted them monitored. I was admitted into the hospital for two days. I was on liquid restriction. I had a bunch of tests ran that came back negative. I did have an AMA test which did come back positive. I am still on water restriction, but I am feeling much better. I'm a bit leery about receiving a booster shot.

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.

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.

Died 5/11/2021 Causes of death listed on death certificate: 1) covid 2) chronic lymphocytic leukemia

Patient went into cardiac arrest on 05/04/2021 when she was getting into a vehicle. CPR was initiated from EMS in the ambulance to the hospital. CPR was done for approx. 30 minutes when family asked them to stop. Patient passed away on 05/04/2021.

Heart attack; Arterial occlusion/artery was blocked; Fluid loss; Acute haemorrhagic ulcerative colitis; Diarrhea; Bowel obstruction; Hemorrhoids; Postoperative pain; Groin hernia; Lower extremity mass/big lump on her groin; This is a solicited report based on the information received by Pfizer from manufacturer control number: 21K-163-3910536-00). A contactable consumer (patient) reported that an 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular in Feb2021 (Batch/Lot number was not reported), at the age of 82-year-old, as single dose for covid-19 immunisation; adalimumab (HUMIRA), via subcutaneous from 2011 (Batch/Lot number was not reported) and ongoing, at 40 mg (1 in 2 wk) (40MG/0.4ML) for rheumatoid arthritis and ulcerative colitis. Medical history included ulcerative colitis, control unspecified blood condition and heart issues. Concomitant medications included sulfasalazine taken for colitis ulcerative, start and stop date were not reported; prednisone taken for colitis ulcerative, start and stop date were not reported; folic acid taken for control unspecified blood condition, start and stop date were not reported; atorvastatin calcium (LIPITOR) taken for heart issues, start and stop date were not reported; isosorbide taken for heart issues, start and stop date were not reported; losartan potassium (COZAAR) taken for heart issues, start and stop date were not reported; metoprolol taken for heart issues, start and stop date were not reported. The patient previously took the historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 81-year-old, in Jan2021 for covid-19 immunization. The patient experienced heart attack on 19Apr2021, groin hernia in Mar2021, lower extremity mass in Mar2021, acute haemorrhagic ulcerative colitis on 13Apr2021, diarrhea on 13Apr2021, bowel obstruction on Apr2021, fluid loss on 13Apr2021, arterial occlusion on 19Apr2021, hemorrhoids in Apr2021, postoperative pain in Apr2021. The patient hospitalized from 18Apr2021 to 25Apr2021 due to these events. It was reported that the patient with events of heart attack, groin hernia, big lump on groin, bleeding a lot as a complication of ulcerative colitis, diarrhea, blockage in bowels, loss of fluids and artery was blocked and non-serious possible hemorrhoids and postoperative pain with Humira 40mg/0.4ml (Adalimumab). In Mar2021, the patient experienced groin hernia and big lump on groin. In Apr2021, the patient experienced blockage in bowels, possible hemorrhoids and postoperative pain. On 13Apr2021, the patient experienced bleeding a lot as a complication of ulcerative colitis, diarrhea and loss of fluids. On 19Apr2021, the patient experienced heart attack and artery was blocked. On 19Apr2021, the heart attack and artery was blocked resolved. On 20Apr2021, the diarrhea resolved. On 25Apr2021, the bleeding a lot as a complication of ulcerative colitis resolved. In Apr2021, the groin hernia, big lump on groin, blockage in bowels, loss of fluids, possible hemorrhoids and postoperative pain resolved. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. Unknown stool softener also considered as suspect. In Mar2021, patient felt a big lump on her groin that was determined by physician as a hernia through physical examination and not an imaging test. On 09Apr2021 she had an outpatient surgery due to hernia in her groin. When she took acetaminophen as prescribed she had a blockage in her bowels and took unspecified stool softener which caused terrible diarrhea. On 16Apr2021 she went to the emergency room due to the diarrhea and had loss of fluids and just went home even when advised not to go home. On 18Apr2021 she was continued having diarrhea, she went back to the emergency room and had unspecified blood test that confirmed she was having a heart attack while on emergency room due to not taking her medications for the heart because was told not to take any medication while having diarrhea which she also temporarily interrupted her Humira while having diarrhea. Physician advised to admit patient to the hospital as she was told she was having a heart attack. On 19Apr2021, she had another stent because the artery was blocked from her previous stent. On 25Apr2021 she was discharged. She believed that her hospitalization was prolonged to nine days (as reported) due to she was bleeding a lot as a complication of ulcerative Colitis. She had a shot of covid 19 vaccine before at least one symptom happened therefore covid 19 vaccine was considered as co suspect product. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On Jan2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. On Feb2021, patient received second dose COVID-19 vaccine manufactured by Pfizer. The patient was treated with acetaminophen. The patient underwent other lab tests and procedures which included blood test: heart attack on 18Apr2021, laboratory test with unknown results in 2021. The action taken in response to the events for adalimumab was unknown. The outcome of the events heart attack, Arterial occlusion/artery was blocked, Postoperative pain was recovered on 19Apr2021. The outcome of the event groin hernia, Lower extremity mass/big lump on her groin, Bowel obstruction, Fluid loss, Hemorrhoids was recovered in Apr2021; of the event Acute haemorrhagic ulcerative colitis was recovered on 25Apr2021; of the event Diarrhea was recovered on 20Apr2021. The reporter's causality for the events of heart attack, groin hernia, big lump on groin, bleeding a lot as a complication of ulcerative colitis, diarrhea, blockage in bowels, loss of fluids, artery was blocked, possible hemorrhoids and post operative pain with humira 40mg/0.4ml (adalimumab) was no reasonable possibility. The reporter's assessment of the causal relationship of the events with the BNT162B2 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. Manufacturer opinion is that there is no reasonable possibility that the events of heart attack, groin hernia, big lump on groin, bleeding a lot as a complication of ulcerative colitis, diarrhea, blockage in bowels, loss of fluids, artery was blocked, possible hemorrhoids and post operative pain are related to humira 40mg/0.4ml(adalimumab). No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Steady decline under hospice care which began 1/4/2021 r/t CVA hx. Mild improvment at times with consistent decline throughout until expiration 7/15/21 at facility.

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.

atrial fibrillation; Headaches everyday, after first vaccine; Rapid heartbeat for a week and a half, after first vaccine; Very weak legs, after first vaccine; Extremely tired, after first vaccine; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported, expiration date not provided) at age of 82 years old as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced atrial fibrillation, headaches everyday, after first vaccine, rapid heartbeat for a week and a half, after first vaccine, very weak legs, after first vaccine, extremely tired, after first vaccine, all on an unspecified date. Clinical course: Caller stated a few days later, she had some reactions to her first shot. Caller reported that she had headaches everyday, a rapid heart beat for a week and a half, very weak legs, and she was extremely tired. Caller states her Cardiologist knows about her health concerns, and she did go into atrial fibrillation, but he didn't give her any specific answers. Caller did not specify when she went into atrial fibrillation. The outcome of the events was unknown. Information on the lot/batch number has been requested.

R29.90 - Stroke-like symptom I63.9 - Cerebrovascular accident aborted by administration of thrombolytic agent (CMS/HCC) R29.810 - Facial weakness

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

Patient has a long standing history of CHF and AFib, however, patient had a syncopal episode on 01/25/2021 in the morning. Per her hospital admission note, she stated that she felt fine, stood up, became dizzy and was able to lower herself to her chair then went unresponsive for a few minutes, but did regain consciousness. When she arrived to the emergency department, she was in atrial fibrillation with RVR with rate in the 140-150s. While the AFib is long standing, the RVR is new and potentially unexplainable. This was resolved with cardizem drip ending at 2220 on 01/25/2021. Alternatively, this patient is being put into VAERS as there are 2 other patients hospitalized with cardiac issues and received vaccine from the same pharmacy with the same lot number.

Per the ED Physician documentation and report from family, patient had been experiencing some chest pain for the last week to week and a half with SVT before presenting to the emergency department. patient had a holter monitor study earlier in the week that results were pending. 1/23/21- patient arrives to the ED via ambulance with complaints of sharp chest pain, palpitations and heart rate in 150's. Patients troponin level then elevated and it was determined patient was having a NSTEMI. 1/24/21- patient had recurrent episodes of SVT and family decided patient would benefit from further cardiac workup so she was transferred to a higher level of care. Unknown if patient has discharge from the facility we transferred her to. This patient is felt to be of significance since she is 1/3 patients currently in our facility who developed cardiac/blood issues post vaccination from the same pharmacy with the same lot number vaccine. VAERS reports were put in for all three to determine if further investigation is needed.

Resident received the COVID vaccine on 1/19/2021. On Sunday, 1/24/2021, she started to have chills and fever. She stated her fever was 100. On Tuesday, 1/26/2021, she went to Urgent Care, a CXR was done and MD said it was pneumonia. Resident was administered Ceftriaxone Sodium IM and has a prescription for Levofloxacin daily.

Began with vomiting and diarrhea. C/O chest pain. Bradycardia. Hypotension. 2 seizures in 45 minutes after not having one in years. We gave fluids. Gave Zofran. Comfort measures. Pt passed at midnight. Was completely fine one day before. Had minimal issues with COVID though did have a pneumonia that was treated w ATB early on and resolved.

My mom received the Covid 19 vaccine on Jan 5, 2021 and became very about a week later. I was informed that she tested positive for Covid 19 on January 14th. One January 17th she became very tired and weak and would not eat. Hospice called me and told me that she was in a decline state. I saw her on January 25 and 26 and she was just sleeping and could not open her eyes. Her vitals were good and she seemed to understand when I talked to her - she would squeeze my hand and moan but she could not talk or open her eyes. My mom passed away on January 27, 2021 just 22 days after receiving the Covid 19 vaccine. She was very think to begin with and being to weak and tired to eat resulted in her losing even more weight. Some of the other residents were given fluids to help and they recovered. My mom was not given fluids. I believe there were 20 deaths in her care home for the month of January when they vaccinated. This was an alarming number of deaths for the home. The facility had very few Covid deaths in 2019 and 2020. I asked every week if they had any Covid and or Covid deaths and this amount was shocking to me and the workers there.

12 days after first vaccination: Dizziness; high blood pressure; nearly passed out; right arm numbness; inability to grip or pick up items with fingers; feeling of "lopsidedness"; unsteady on feet, requiring assistance to walk. Primary care physician recommended ER visit where possible stroke was diagnosed. Hospital MRI confirmed: " Left acute arterial ischemic stroke, MCA (Middle cerebral artery)" . Spent 2 days in hospital with high blood pressure, dizziness. Residual right finger numbness upon release.

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.

Patient received his first dose of Covid vaccine on Jan. 30, 2021. On Jan 31, 2021 at 6:08 AM, patient noted unresponsive per facility. Code blue was called and 911 dispatched. He expired in the ER.

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.

PATIENT WAS ADMITTED TO ER FOR ALTERED MENTAL STATUS / UTI SEPSIS WITH SEPTIC SHOCK / COVID AND COVID PNA PATIENT WAS ADMITTED TO ICU AND DIED . POA WISH TO WITHDRAWL EXTRME MEASURES

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.

Sharp pain behind right knee. Subsided by evening. Went to The ER Sunday morning, Feb. 21. They x-rayed leg and found nothing unusual for a woman my age. Then they conducted a scan and discovered a blood clot behind my knee. Since then, I have had intermittent pain. The Doctor referred me to a hematologist which I will see this week. Prior to the vaccination have never had a blood clot. It occurred three days after the vaccination. Coincidence? I think not.

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.

Initially, a UTI developed. As the UTI resolved, double pneumonia took hold. At the hospital they then discovered multiple clots in the legs.

Blood clot, swelling noticed a few hours aftee vaccine. Probably coincidence but felt it should be reported. Im not sure if the doctor she saw for blood clot knew she got the vaccine. It was a different clinic.

On 3/8/2021 the patient presented to the ED with stroke-like symptoms. Reason for admission: suspected TIA. Acute CVA-has been ruled out. Incidental finding CT head 9 x 5 mm lesion possibly meningioma, but scans of CTA head and neck no lesion, MRI of the brain shows no lesions.

She died 5 days after her second vaccine; This is a spontaneous report from a contactable consumer. An 83-year-old female patient (Not pregnant) received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number not provided), via an unspecified route of administration in the left arm on 12FEB2021 at 03:00 PM (at the age of 83-years-old) at single dose for covid-19 immunisation. The subject had a history of Heart condition and thyroid. Relevant concomitant medications included calcium, fish oil, multivitamin and potassium. The patient died on 16Feb2021 (12:00 PM), 5 days after her second dose of vaccine (as reported). The cause of patient's death was unknown. She had no adverse effects until her death. It was unknown if autopsy was performed. Information on batch/lot number was requested.; Reported Cause(s) of Death: She died 5 days after her second vaccine

Client was scheduled to get second dose of Pfizer Covid-19 on 02/19/21. Received call from family stating that client suffered a stroke on 02/18/21 and was admitted to hospital.

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.

Death; Kidney shutdown; This is a spontaneous report from a contactable consumer reporting for the mother. An 83-year-old female patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm, on 28Feb2021, as single dose, for COVID-19 immunisation. Medical history included unspecified ailments. Concomitant medications were not reported. The patient experienced kidney shutdown (medically significant) on 02Mar2021 with outcome of unknown and death (death, medically significant) on 14Mar2021. The cause of death was unknown. It was not reported if an autopsy was performed. The information on the lot/batch number has been requested.; Reported Cause(s) of Death: Death

A-Fib; cardiologist saw it on the computer, an arrhythmia; hard poundings that were very bad, clarifies like fist continually pounding in her chest; feeling something strange, like a flurry by the heart; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6198, Expiration Date: Not reported) via an unspecified route of administration on arm on 19Feb2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included ongoing bronchiectasis (At least a year but not sure). Concomitant medication included ongoing tiotropium bromide (SPIRIVA; 18 ug, capsule) via nasal route at 18 ug, once a day (inhalation/At least a year but not sure) for bronchiectasis. It was reported that, the patient had her first vaccine on 19Feb2021. On 20Feb2021, she started feeling something strange, clarifies like a flurry by her heart, she doesn't know what really. She states that on 21Feb2021 and 22Feb2021 she had hard poundings that were very bad, clarifies like fist continually pounding in her chest. On 23Feb2021, she saw the cardiologist and he put her in the hospital. She states that it was probably a reaction from the vaccine, it was A-Fib. It was probably a reaction, but nobody can say, she was 83 but healthy, no diabetes, high blood pressure or anything except one little thing. Today was the date for the second dose, and she was reluctant to get it. Caller clarifies that the pounding subsided on 21Feb2021 and started again on 22Feb2021 and on 23Feb2021 she went to the cardiologist. Treatment included Aleve hard poundings that were very bad, clarifies like fist continually pounding in her chest AE: clarifies that it was going for quite a while, it was undeniable on 21Feb2021. States on 22Feb2021, it lasted a few minutes. feeling something strange, like a flurry by the heart AE: states that it was there for a minute. A-Fib: states that the cardiologist saw it on the computer, an arrhythmia. States they saw it at the doctor's office on the computer, she didn't feel it on 23Feb2021. States it is unknown if it started on 21Feb2021, 22Feb2021, 23Feb2021. States she doesn't know when it ended, she was put in the hospital. States she didn't feel it to know so she couldn't identify it, but it showed on the computer. Treatment with Aleve, but no other treatment, she was afraid to take anything. Hospitalization: Caller states that she went to the cardiologist on 23Feb2021 and states he saw on the computer the AFIB and admitted her. Clarifies that he sent her to the emergency room and then she was put upstairs into a room and may have been admitted when she went upstairs, she was there for a couple of days. She states that they didn't have a room at the time, they had lots of people with Covid. States she was admitted on 23Feb2021. She states she was released on she believes the 26Feb2021 but could be 26Feb2021 or 28Feb2021 but believes 26Feb2021. States the was put on medications to monitor to see what would coincide with each other, she is not sure. Patient was started on the following medications during her hospitalization and prescribed them. Metoprolol 25mg once a day by mouth, started when admitted to the hospital. Dofetilide 250mg capsule twice a day by mouth, started after admission to hospital. Blood thinner called Eliquis 2.5mg twice a day by mouth, started during hospitalization. Clarifies that she was not on these medications before the vaccine, she started them when she was at the hospital and takes them now. States she was one medication, but she stopped taking it right away and it has nothing to do with this. For event A-Fib, which results in Emergency Room visit and Physician Office visit. The seriousness of the events was reported as hospitalization. The event Feeling abnormal was recovered on 20Feb2021, Chest discomfort was recovered on 22Feb2021, Arrhythmia was recovered on an unspecified date in 2021, whereas unknown for another event.

Patient developed generalized weakness with peripheral neuropathy four days after getting second injection. Patient had a right MCA distribution infarct on 3/24/21. Last injection was on 2/25/21. Patient died on 4/7/21 from consequences of infarct.

Vertigo symptoms occurred 4/6/2021 less than 24 hours after vaccine was given. They persisted for 3 days along with balance issues. on 4/9/2021 at 6:50 am stroke type symptoms occurred with slurred speech and paralysis on Let side arm and leg. Several stroke episodes, and blood pressure spiking occurred over a 3 hour period. Low grade fever presented on 4/11/2021. After much testing she was diagnosed with a series of TIA attacks found to be and averse effect from The COVID vaccine.

Patient developed pain in her left calf 4 days after the 1st Pfizer COVID-19 vaccine. She was sent for venous doppler and found with an extensive superficial venous thrombosis in the left great saphenous vein that was only cm from the deep system. The clot extended from the upper calf to the thigh. She was and is being treated for DVT as the clot was so extensive. She has no history of clots. She does have varicose veins and has not been as active as usual. She is currently still in treatment .

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.

Patient found unresponsive in home, attempted CPR and provided epi x 3 in transport to ED. ACLS continued at the ER, but RSC unable to be achieved. Death pronounced at 0925 AM

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.

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.

She received her second COVID shot at the end of March first week of April. My mother had a stroke, several seizure and her lungs were filled with blood clots. She had to have a procedure to remove the largest one next to her heart. My mother has always been healthy and has never had any of the following issues in her life. She gets regular checkup and I spoke with her on April 19, 2021 at 12:00pm Central time and she was fine but at 1:20pm my brother who is staying at her house said she was having a seizure. I talk to my mother at least four times a day and she has never in 83yrs experienced anything like this. She doesn?t remember right now where her shot was administered but my brother took her but he is mad at me because I have full power of attorney and he is not happy. Therefore, he will not give me the information that is needEd to give to your office. My mother was admitted to the ICU. She is now at their rehab center in a hospital. Once my mother is released from the hospital she is moving with me out of state. This is and unexpected expense that I will need assistance with but I don?t mind because it is my mother and now someone has to be with her 24/7.

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

may be blood clot; Something happened with my knee and it has just got worse; I was thinking maybe it is a pulled muscle or something but it is very bad now; This is a spontaneous report received from a contactable consumer (patient). An 83-year-old female patient (5 feet 1 inches, about 120 pounds) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198, patient was not sure) via an unspecified route of administration at left arm on 22Feb2021 (83-year-old at time of vaccination), at single dose; the second dose of BNT162B2 (lot number: unknown) via an unspecified route of administration on 15Mar2021 (83-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated she has got both the shots of Pfizer (Covid-19 vaccine) and at the end of the first one or it is like eighteen days, just before the second shot, something happened with her knee and it has just got worse (from 12Mar2021). She did not connect that with the Pfizer shot and I was thinking maybe it is a pulled muscle or something but it is very bad now. She would like to know what she can do. Also, she is thinking may be blood clot at this point and she would like to have it checked. She thinks that she should be able to contact somebody to actually get some physical test on this. She tried heat and cold alternate and Absorbine Jr. and Aspirin. It varied with the days, she thinks she has taken Aspirin about twice a day and it is a tablet and it was 325 mg and she took two of those, orally. Therapeutic measures were taken as a result of the event and included "heat and cold alternate and Absorbine Jr. and Aspirin". The outcome of the event was not recovered. Information on the lot/batch number has been requested.

This 83 year old female received the Covid shot on 1/19 and went to the ED on 2/3/21 and was admitted on 2/3/21 with the diagnoses listed below. I63.9 - Cerebral infarction, unspecified G50.0 - Trigeminal neuralgia J12.82 - Pneumonia due to Coronavirus disease 2019

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.

I60.9 - Subarachnoid hemorrhage (CMS/HCC) J18.9 - Pneumonia I63.9 - Acute CVA (cerebrovascular accident) (CMS/HCC) N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness

I26.99 - Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present

Pain in right thigh; Pain moved down leg into knee and calf; Pain moved to right foot, felt like stone bruise when walking; Pain moved to left foot and leg; gums bleeding; very tired, no energy. Had 2 steroid shots; went to Podiatrist for Plantar Fascia; He detected possible blood clot.

STROKE; Facial droop; This is a spontaneous report from a contactable physician. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular on 02Mar2021 (Batch/Lot Number: EM9809) as 2ND DOSE, SINGLE for covid-19 immunisation; and carbidopa, levodopa (DUOPA), via percutaneous j-tube from 2018 (Batch/Lot number was not reported) and ongoing, at unspecified dose for advanced parkinson's disease. Medical history included maternal history of strokes, and paternal history of strokes, both on unspecified dates. Concomitant medication included carbidopa, levodopa taken for an unspecified indication, start and stop date were not reported. Historical vaccination included first dose of BNT162B2 on 20Jan2021, intramuscular, with lot number: EL19261 for covid-19 immunization. The patient experienced stroke on Apr2021 with outcome of unknown, and facial droop on Apr2021 with outcome of recovering. Details were reported as follows: The patient felt like she experienced a mini stroke in Apr 2021. She had her Peg and J tube replaced on 16Apr2021 because they came completely out. Her husband was not sure if the pump was working states he could not saw the medication. Her husband had the pump disconnected from her. NCM advised her husband to run the pump over paper towels. Her husband did as instructed and could then saw the medication. He then connected patient to the pump and the pump ran without any error codes or alarms. Her husband wanted to make sure patient did not need a new pump since she got new tubing. NCM assured that the current pump seemed to be working fine with the new tubing. She left sided mouth droop in Apr 2021. She was taken to the local hospital via emergency medical services (EMS). She was then transferred to Hospital in for evaluation. She was in the ER awaiting a bed for 20 hours. The primary reporter did not know if any tests or medicine obtained as he did not receive any paperwork. After 20 hours, she was discharged from the ER home. She had a brain waves test a few days later to confirm if stroke had occurred. The primary reporter stated he did not feel the COVID vaccine was related to he events of Mouth droop and possible stroke. The patient underwent lab tests and procedures which included brain waves test: results pending on 21Apr2021. The action taken in response to the event(s) for bnt162b2 was not applicable, and for carbidopa, levodopa was dose not changed.; Sender's Comments: Based on information provided, considering the age and medical history of the patient, the event stroke is assessed as unrelated to BNT162B2. The event "facial drop" is assessed as symptom of the event stroke, hence not related to BNT162B2 either. 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.

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.

Approximately 1 week prior to admission patient developed increased bruising and a few minor episodes of epistaxis. She also experienced 1 day of diarrhea which was followed by 4 days of significant fatigue with subsequent improvement. Labs performed by PCP 5/21/2021 showed platelet count of 2000 and when labs resulted on 5/22/2021 patient was instructed to present to the emergency department where her count was repeated and was less than 2000. Patient is receiving 4-day course of IV immune globulin 20 g and prednisone 1 mg/kg (60 mg) daily for 2-3 weeks Patient received 1 unit platelet transfusion in emergency department on 5/22/2021 COVID-19 vaccination could have precipitated relapse of ITP

a massive stroke; This is a spontaneous report from a contactable consumer (patient). A 83-years-old female patient received bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose at the age of 83-year-old for covid-19 immunization. Historic vaccine was bnt162b2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunization. Concomitant medications were not reported. The patient had 2 terrible reaction followed by a massive stroke within a week of the 2nd shot. She was still recovering (as reported) from the stroke. It was terrible. Stroke was too much to handle. She was still going to Dr. She had a caregiver paid at home. The seriousness of event was reported as life threatening and hospitalization. The patient was hospitalized duration of stay: 3 days. AE required visit to: Intensive care unit (3 Days). The outcome of event was not recovered. Information on the Lot/Batch number has been requested.

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.

Pneumonia; Disease progression; They found a 9cm mass on her liver.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable pharmacist and Other Health Professional reported that an 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot number was not reported) at the age of 83-year-old, at single dose for covid-19 immunisation; palbociclib (IBRANCE, Film-coated tablet, strength 100 mg), via an unspecified route of administration from 24Jul2020 (Batch/Lot number was not reported) to 30May2021, at 100 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. It was reported patient stopped the palbociclib a few days ago. It was notified on 25Jun2021 Friday. Patient was home hospice now. She had pneumonia after her COVID vaccine a month ago and then when she went on for her scans they found a 9cm mass on her liver. So the doctor decided to stop palbociclib as a sign of disease progression and she was declared home hospice. There was no hospitalization. The patient underwent lab tests and procedures which included scan: found a 9cm mass on her liver in 2021. The action taken in response to the events for palbociclib was permanently withdrawn. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association and the limited information available, the causal association between the event pneumonia and the suspect products palbociclib and BNT162B2 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 RAs, Ethics Committees, and Investigators, as appropriate.

Unknown which vaccine was given. Only selected Pfizer because VAERs wouldn't let me proceed. Was not given at hospital. Given somewhere else. Cardiologist believes that that pericardial effusion (admitted here for that) may have been due to COVID vaccine given 2 weeks prior to admission, even though patient has advanced age and significant cardiac history

death NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) Pulmonary emboli (CMS/HCC) Acute kidney failure, unspecified Thrombocytopenia, unspecified

4/6/21: unwell , tested for Covid 4/15/21: Patient condition continues to decline - family informed 4/15/2021, 8:56am Patient expired

Lost 5 pounds; one bout of diarrhea; night sweats so bad; nausea and vomiting; headaches; nausea and vomiting; diagnosed with bronchial pneumonia; This is a spontaneous report from a Pfizer Sponsored Program. Information was received from a contactable nurse (the patient). A 83-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 12:30 (Batch/Lot Number: EL6204) as single dose for covid-19 immunisation (Age at vaccination 83 years) . Medical history included mycobacterium avium complex infection. On 24Feb2021 the patient received the first dose of BNT162B2 vaccine. Concomitant medications included multivitamin (MULTIVITAMIN) taken for an unspecified indication from 19Mar2021 12:30 to 19Mar2021 12:30; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX (B50)) taken for an unspecified indication, start and stop date were not reported. The patient was diagnosed with bronchial pneumonia (medically significant) on Mar2021 with outcome of recovered , lost 5 pounds (non-serious) on an unspecified date with outcome of recovered , headaches (non-serious) on Mar2021 with outcome of recovered , nausea and vomiting (non-serious) on Mar2021 with outcome of recovered , one bout of diarrhea (non-serious) on an unspecified date with outcome of recovered , night sweats so bad (non-serious) on Mar2021 with outcome of recovered. Therapeutic measures were taken as a result of diagnosed with bronchial pneumonia and included antibiotics, albuterol and cough medicine. Course of the event. Caller states that she then had a sore throat and nasopharynx and throat felt like she was breathing fire. It got worse and worse. Caller states that within 48 hours of receiving the vaccine, she also began coughing and coughing. She had headaches, nausea, vomiting, one bout of diarrhea, and night sweats so bad that she had to change her pillow and bedding and was soaked from the waist up. Caller adds she was diagnosed with bronchial pneumonia. She had an appointment with a pulmonologist doctor and was seen at the clinic. They did x-rays, cat scans, and she was unable to do a breathing test because she could not quit coughing. Caller does not have additional details. Gave her antibiotics for 21 days, a nebulizer of albuterol and saline and they gave her cough medicine. It was the same cough medicine with codeine. She spent 6 days just at the clinic with tests in the doctor and came home from the train. Caller adds she was not admitted. This all stretched out over 3 weeks and gradually increased. Follow up information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The contribution of patient's age cannot be completely ruled out in the occurrence of the events. 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.

Unknown as to any correlation with vaccine as this was a hospice patient that was already experiencing decline. Patient became Jaundice for approximately one week prior to expiring.

Resident vaccinated-1/7/21 Resident covid positive 1/11/21 Resident covid PNA-1/12/21 Resident hospitalized 1/16/21 Resident deceased 1/20/21

bp 167 hr 110 107 PMG of afib, family states happens often; called dr. states to see him friday if continues

2nd dose headache prior to leaving vaccine site, dizzy that after noon, still headache took Tylenol did sleep fair, next day, spaced out, also had periods of sweating, around 7pm I felt exhausted, then started aching , did this throughout the night and continued thought today , took my Blood pressure pressure was normal but indicated I was having a-fib, I just feel out of sorts and haven't contacted my physician because of the expectation of side effects, After taking my BP I realized the reason for my sweating was due to A-FIB ,caused by vaccine

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:

Resident was weak, fatigued and had a fever of 101. F the following morning after receiving the 2nd dose of vaccine. Later in the day she was feeling better and vital signs were WNL. The next morning, she was found unresponsive and pronounced dead by paramedics.

Patient received her first covid vaccine on 1/27/21. on 1/30/21 she presented to the emergency department complaining of nausea, she had a negative work up, felt better and was sent home. on 2/5/21 she returned to the emergency department more ill-appearing and complaining of "feeling sick". she had fatigue, chills, decrease in activity level. her work up at this visit revealed multiple metabolic abnormalities, sepsis and bacteremia. She ultimately passed away at this visit with at cause of death listed as acute liver failure, pneumonia, and DIC>

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

On Monday, 15 February my mother in law suffered a stroke. She has been hospitalized since the stroke at Hospital.

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

First dose Pfizer given at assisted living on 1/14/21 she was subsequently admitted to hospital and got her second dose but Moderna was given instead of Pfizer on 2/8/21. She had been improving but in the days following the Moderna vaccine she developed fever and then her mental status declined. She was discharged back to assisted living. Suspected UTI, and moderate dementia, placed on hospice (2/12/21). Died on 2/13/21.

6 hours after I had vaccine I developed A fib which lasted for 3 hours before I converted. I haven?t had an episode of a fib in over a year.

1/23 - Mild injection site discomfort. Appetite loss compared to previous day. Beginning loss of mental acuity compared to previous day. 1/24 - Continued loss of appetite. Near complete loss of ability to move. Continued decline of mental acuity. Very little speaking. 1/25 - Stopped speaking completely. Loss of bowel control in the evening and continued until death. Complete loss of appetite. 1/26 - Near complete loss of ability to swallow. Moved to hospice 4:00pm. 1/27 - Died 4:00am

Severe thrombocytopenia with epistaxis requiring hematology consultation, IVIG, and ultimately daily eltrombopag therapy to correct.

THROMBOCYTOPENA- Platelet count usually 170K 1/8 covid vaccine #1 1/12 platelet count 15k 1/14 " 10k Given high dose dexamethasone 1/29 covid 1/25 platelets 46k vaccine #2 2/2 paltelets 4k again given high dose dexamethasone 2/9 platelets 184k 2/16 platelets 85k

Received 1st dose Pfizer-BioNTech vaccine Lot EN9899 exp 03/2021 on 01/18/2021 during CVS onsite clinic for Assisted Living Facility. Received 2nd dose Pfizer-BioNTech vaccine Lot EN5318 Exp 05/2021 on 02/08/2021 during CVS onsite clinic for Assisted Living Facility. On 02/10/2021 during routine employment screening, tested positive for COVID-19. On 02/12/2021 reported generalized malaise, otherwise denied symptoms. On 02/21/2021 employer notified by family friend that patient was treated at Medical Center on 02/20/2021 secondary to sudden onset difficulty swallowing, impaired speech, and facial droop. Employer later notified patient was then admitted to the ICU at aforementioned hospital secondary to dx of CVA.

RECEIVED PFIZER COVID VACCINE 1ST DOSE ON 02/13/21. WENT TO ER ON 02/28/21 WITH COMPLAINT OF BRADYCARDIA AND FELT FAINT. DIAGNOSED WITH SYNCOPE AND COLLAPSE AND ABCESS OF LOWER LEFT LUNG WITH PNEUMONIA. ADMITTED TO HOSPITAL.

stroke; This is a spontaneous report from a contactable Pharmacist, the patient's daughter-in-law. An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 05Feb2021 (at the age of 84-years-old) as a single dose for COVID-19 vaccination. Medical history included stroke and atrial fibrillation from unknown dates. Concomitant medications were not reported. On 12Feb2021, the patient experienced a stroke. The clinical outcome of the event stoke was unknown. No additional information was reported. Information about lot/ batch number has been requested.

She was week, fell, wouldn't eat, drink or get out of bed. Died after being sent to hospital 3 times and ended up on hospice

Patient developed COVID after vaccines. There was an outbreak at her facility . She ended up with pneumonia and expired on 03/07/2021

About 11 hours later, severe weakness in muscles causing her to fall in her apartment. She was admitted to hospital, and had fever and cough which progressed to pneumonia. Event further weakened already weak kidney function. After a week in hospital was transferred to nursing home long term.

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.

I had periods of dizziness like my atrial fibrillation was acting up every few minutes all day, both days; Left arm was sore for a day; I had periods of dizziness; I was fatigued and took 2 naps each day; This is a spontaneous report from a contactable consumer (patient herself). An 84-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: EN6200), via an unspecified route of administration on the left arm, first dose on 23Feb2021 12:15 at single dose for COVID-19 immunization. Medical history included atrial fibrillation from an unknown date and allergies to penicillin. The patient is not pregnant. No other vaccine received in four weeks. Concomitant medication included cyanocobalamin (B12-VITAMIIN), vitamin b complex (B COMPLEX), calcium (CALCIUM), ascorbic acid (VIT C), and rivaroxaban (XARELTO) from unspecified dates in two weeks. On 24Feb2021, the patient experienced left arm was sore for a day however the day following the vaccination and the day after that (Wed and Thursday) patient had periods of dizziness like her atrial fibrillation was acting up every few minutes all day, both days. Patient was fatigued and took 2 naps each day. No treatment was received for the AEs. Patient did not have COVID prior vaccination and not tested with COVID post vaccination. The outcome of the event left arm was sore for a day was recovered on 25Feb2021, and for the other events, it was unknown.

Pulmonary Embolism; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration (Lot Number: EL9261) at 9:00 am on 22Jan2021 (at 84-year-old) in arm right at single dose for COVID-19 immunization. Other medical history was reported as high blood pressure (HBP), high cholesterol, thyroid cancer removed in 2003 (thyroid cancer from an unspecified date to 2013), breast cancer from 2009, hemorrhoid surgery in 2011, polymyalgia rheumatica (2018 & 2020), hip injections in 2018 & 2020, and cataracts removed both eyes in 2018 (cataracts from an unspecified date to 2018). The patient had allergy to morphine. Concomitant medications (other medications in two weeks) included levothyroxine sodium (SYNTHROID), metoprolol, triamterene, montelukast, and atorvastatin calcium (ATOR), all taken for an unspecified indication, start and stop date were not reported. There's no other vaccine in four weeks. The patient experienced pulmonary embolism at 02:00 am on 01Feb2021. The event resulted in emergency room/department or urgent care, hospitalization for 3 days, life threatening illness (immediate risk of death from the event). The event treatment included apixaban (ELIQUIS). The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EM9809) via an unspecified route of administration at 9:00 am on 12Feb2021 in arm right at single dose for COVID-19 immunization. No COVID prior vaccination, and no COVID tested post vaccination. The outcome of the event was unknown.

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 vaccine Wednesday and felt a little dizzy after the shot. Sunday morning she woke up very dizzy and ended up passing out in her kitchen while getting her morning coffee. She hit her head and was taken to the ER. Her blood pressure was found to be very high (systolic 218). CT scans revealed 2 blood clots in her lungs per pt. She was hospitalized for 2 days. She reports trouble walking now.

Altered mental status Intracranial hemorrhage (CMS/HCC) Hypertension Cerebral brain hemorrhage (CMS/HCC

She developed chills she couldn't control and fell asleep all afternoon, evening and through the night. I spoke with her twice and my uncle and aunt checked on her three times, all three she was freezing cold and too tired to get up. In the morning, she was dazed, cold and walked to the bathroom, where she collapsed to her death. Paramedics could not revive her. My mom died Saturday morning - within the 24-hour period of her vaccine. She was feeling so great leading up to it, active, stripping the guest bedroom sheets, bubbly, and excited for us to be able to finally visit her soon.

Patient received 1st dose Pfizer COVID vaccine on 2/5/2021 and second dose on 2/26/21. She had no adverse reaction to either dose. Around 3/2/2021, she saw her physician complaining of pain in her arm, which was attributed to gout. At the time, she also had a nonproductive cough, generalized weakness and one episode of loose stool. She presented to the emergency room on 3/7/21 with significant hypoxia. She tested positive for COVID 19 by both rapid test and PCR. A quantitative test for COVID antibodies was sent out to a reference lab on 3/7/2021 and resulted on 3/11/2021 as >250 U/mL. Pt. required CPAP, BiPAP, High Flow Oxygen and ultimately intubation. Was not oxygen dependent before hospitalization. Pt. treated with dexamethasone, 2 doses of Remdesivir (then held due to acute kidney injury), tocilizumab X 1 dose, 1 unit COVID-19 convalescent plasma. Pt. expired on 3/19/2021. Sample sent for genome sequencing to check for variants of interest in joint effort between pathology and infectious disease. Report not yet available.

severe anaphylactic shock; High blood pressure; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 23Feb2021 09:30 (Lot Number: EN6200) as single dose for covid-19 immunisation at age 84 years old. Medical history included low thyroid and allergies to grasses. The patient was not pregnant. The patient had no Covid prior to vaccination and was not Covid tested post vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. No other vaccine taken in four weeks. The patient previously received the first dose of BNT162B2 administered in left arm on 02Feb2021 09:30 AM (lot no: EC9265) for COVID-19 immunization. On 16Mar2021 09:15 AM, 15 minutes after eating usual breakfast: avocado/toast, coffee, almond milk, the patient went into severe anaphylactic shock: extreme itching on palms, red welts on body, explosive diarrhea, dizzy/fainted, extreme blood pressure drop to 60/XX, in/out of consciousnes, loss of bowel/urine. Rushed to ER. High blood pressure 7 days after (Mar2021). The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, emergency room/department or urgent care and were considered life threatening illness (immediate risk of death from the event). Treatment given in the emergency room includes unknown (as reported), prednisone, Pepcid. Outcome of the event was unknown.

3 days after the covid-19 vaccine, she had a seizure and was taken to the hospital. She was diagnosed with sepsis and died 02/22/2021.

bilateral DVT; This is a spontaneous report from a contactable physician. An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in Arm Right on 25Mar2021 (at the age of 84-years-old) (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. Medical history included CKD, Allergic Rhinitis, basal cell carcinoma, vertigo, dupuytren's contracture, Gerd, hypothyroidism, hypertension, osteoarthritis, osteoporosis, prediabetic, palpitations, sleep apnea, seizures, anxiety, Allergies to medications, food, or other products: BACITRACIN, LATEX, MORPHINE, POLYSPORIN, ADHESIVE TAPE. Concomitant medication(s) included azelastine (AZELASTINE); enalapril (ENALAPRIL); famotidine (FAMOTIDINE); fluoxetine (FLUOXETINE); fluticasone (FLUTICASONE); ipratropium (IPRATROPIUM); levetiracetam; levothyroxine; zonisamide; all taken for unspecified indications, start and stop dates were not reported. The Patient was not diagnosed with Covid-19 prior to vaccination. The patient received first dose of BNT162B2 (lot number: EN6198) via intramuscular in right arm for COVID-19 immunization on 26Feb2021 at the age of 84-years-old. On 29Mar2021, the patient experienced bilateral dvt (life threatening). Therapeutic measures were taken as a result of bilateral dvt: ELIQUIS. The outcome of the event was recovering. Since the vaccination, the patient has not been tested for COVID-19. Information on Lot/Batch number is available.; Sender's Comments: There is not a reasonable possibility that event DVT is related to BNT162B2. This elderly patient had multiple underlying diseases. The event is more likely intercurrent medical condition. 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.

developed a small Pulmonary embolism in Lung; Colitis; This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 84-year-old non pregnant patient female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9264 and expiration date was not reported), via unspecified route of administration in left arm on 11Mar2021 at 09:00, at single dose for COVID-19 immunization. The patient's medical history included Myeloma and concomitant medication was not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201 and expiration date was not reported), via unspecified route of administration in right arm on 18Feb2021 at 09:30, at single dose for COVID-19 immunization. On 25Mar2021 at 09:30 AM patient developed a small Pulmonary embolism in Lung and Colitis, 10 days after second dose of Pfizer vaccine. The patient had received the treatment medication for the adverse event. The seriousness of the event considered as serious due to hospitalization of the patient. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and after vaccination was not tested for COVID-19. The outcome of the events small Pulmonary embolism in Lung and Colitis was recovering. Information on Lot/Batch number was available. Additional information has been requested

Diverticulitis arteries; I had a blood clot after ultra sound; sore arm/Feel sore arms after the first dose; spinal nerve damage/Spinal nerve pain; Legs are burning hot now; Pain felt in calf and thigh; Bone density test/Ultra sound bad; This is a spontaneous report from a contactable consumer(patient). An 84-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 01Feb2021 11:30 (Batch/Lot Number: EN5318) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:30 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. Medical history included angina from 2002 and ongoing, She says she has angina, and if she would have beating problems can she take a Nitro, cholesterol, depression from 2008 to an unknown date, blood pressure, anxiety from 2018 to an unknown date, arthritis from 1998 and ongoing Illness/AE: Arthritis Onset Date: 1998-2002 Stop Date: Ongoing , hypertension from 2002 and ongoing, blood cholesterol increased from 2002 and ongoing, ongoing urinary tract infection On and off, coronary artery disease from 2005 to an unknown date On and off, Family medical history included Mother coronary artery disease Died on 18Oct1967 and Father 1936 other. Concomitant medications included amlodipine taken for blood pressure abnormal from 2017 to an unspecified stop date; atorvastatin taken for blood cholesterol abnormal from 2002 to an unspecified stop date; bupropion taken for depression from 2008 to an unspecified stop date; buspirone taken for anxiety from 2008 to an unspecified stop date; carvedilol taken for blood pressure abnormal from 2002 to an unspecified stop date, 2x a day carvedilol 12.5. On an unspecified date, the patient experienced diverticulitis arteries, had a blood clot after ultrasound, sore arm/feel sore arms after the first dose, spinal nerve damage/spinal nerve pain, legs are burning hot now, pain felt in calf and thigh, bone density test/ultrasound bad. The patient underwent lab tests and procedures which included blood test: unknown results, computerized tomogram: diverticulitis arteries- On and off, investigation: unknown results. Comments: Going to pain clinic. On always, ultrasound scan: bad on Comments: Ultrasound bad, urine analysis: unknown results on comments: on and off. Treatment received for the events sore arm/feel sore arms after the first dose and spinal nerve damage/spinal nerve pain. Outcome of all events was unknown Follow-up (29Mar2021): This is a follow-up report combining information from duplicate reports 2021138557 and 2021162095. The current and all subsequent information will be reported under manufacturer report number 2021162095.

I63.9 - Acute CVA (cerebrovascular accident) (CMS/HCC) E87.6 - Hypokalemia R45.86 - Emotional lability

Early in the around 10am on Feb. 24, 2021 my mother was found dead on the floor of the bathroom. She was found with dried blood coming from her nose.

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

Ischemic stroke; Ischemic stroke causing car accident; This is a spontaneous report received a contactable consumer, the patient. This patient/consumer reported different events for different doses of the same product; this case refers to dose 2.An 84-year-old elderly [non-pregnant] female received the second dose of intramuscular BNT162b2 (solution for injection; Lot ER8731 and expiry information not provided) as a single dose in the left shoulder (deltoid) on 16Mar2021 at 12:00 (at 84-years-old) for COVID-19 immunization. Relevant medical history included ongoing atrial fibrillation, penicillin allergy, fractured tibia (09May2020; surgery to repair fractured tibia, plate and screws installed). The patient has a family history of strokes in maternal grandmother. Concomitant medications included oral rivaroxaban (XARELTO) 20mg once daily for atrial fibrillation ongoing from an unspecified date. The patient previously received COVID-19 immunization with the first dose of intramuscular BNT162b2 (Lot EN6200) in the left shoulder (deltoid) on 23Feb2021 at 12:10 (at 84-years-old) and experienced periods of dizziness like atrial fibrillation was acting up every few minutes all day, both days, left arm was sore for a day, and was fatigued and took two naps each day. The patient denied any COVID-19 prior to the vaccine and the patient was not pregnant at the time of vaccination. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 28Mar2021 the patient experienced an Ischemic stroke and car accident. The patient reported that the events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient explained that she was hospitalized for thirty-two days, including seven days in the Intensive Care Unit. The patient assessed the events serious (life-threatening, hospitalization / prolongation of hosp., persistent / significant disability / incapacity, Important medical event). The patient was tested for COVID-19 post-vaccination via nasal swab PCR on 28Mar2021 which was negative. The patient received multiple treatments for the events including occupational therapy (OT), Speech/Swallowing therapy (ST) , Physical therapy (PT), gabapentin, acetaminophen (TYLENOL) twice daily (BID) and tramadol BID. The outcome of the events Ischemic stroke and car accident was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021216108 PFIZER (Same reporter/patient/product, different dose/events)

N17.9 - Acute kidney failure, unspecified R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction

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

Patient presented to the ED on 3/12/21, was hospitalized on 4/6/21. Patient presented to the ED on 4/13/21 and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was bilateral pulmonary embolism.

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

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)

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

Death SAH (subarachnoid hemorrhage) Observed seizure-like activity Hypo-osmolality and hyponatremia Acute kidney failure, unspecified Thrombocytopenia, unspecified

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

I am the epidemiologist reporting on behalf of patient. Patient received two doses of Pfizer on 01/09/21 and 02/02/21. Case was admitted to hospital on 6/26 due to slurred speech, low heartrate, and low oxygen (75%) and tested positive for COVID-19 via a PCR test. The patient passed away on 07/01/21. Cause of death is listed as sepsis. Death cert # 20210042573.

chest pain; her arm went numb; she experienced deep pain above her knees on both sides; the knees, because of clotting or whatever so she tried to rub some alcohol on her leg; This is a spontaneous report from a contactable Other Health Professional (patient, Dentist). A 84-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EW0167), via an unspecified route of administration at left arm on 26APR2021 at the 84 years old at single dose for COVID-19 immunization. The medical history was ongoing high blood pressure, pain and allergic. The concomitant medications were none. The patient states she goes to the doctor for a checkup for almost 1 year but she cant go because she wasn't able to go anymore because of corona virus and she didn't go out to visit her doctor for almost one year. The patient states she has high blood pressure, but she doesn't have medicine, it was diagnosed a long time ago because the doctor said take this medicine but she wasn't able to get a checkup and wasn't able to get the medicine so she doesn't have medicine. The patient would like to report a terrible effect on herself by the Pfizer vaccine. The patient states she had her first vaccine 26APR2021 and after that she had chest pain on 27APR2021 that lasted for the next day and almost 2 days and then her arm was also numb on 27APR2021 and she just put some hot and cold compress on her chest and she just rested and it just went away, but last week the same thing, her chest became painful and she saw this number about the Covid 19 and that's why she's calling, what should she do should she get the second vaccine? The patient states she did not report to anybody yet, this is her first time. The patient states last week, it came back again and then on the next day 27APR2021, it was very deep and painful in her knees, both sides, left and right above her knees. The patient states yes, sometimes its very painful. The patient states not now, but last week the pain was in her chest and she put a cold compress on it. The patient states after the numb and pain, its not like pain, its deep pain, that's why she's bothered. The patient states it's really serious, the knees, because of clotting or whatever so she tried to rub some alcohol on her leg, that's what she did. Chest Pain; very deep and painful in her knees: The patient states it's slowly not pain, it's not very painful like before, the first and second time that it occurred. The patient states it's pain, but it's like better, it's getting better. The patient states she cannot say that it's recovered, she feels a little better. The patient confirms it is ongoing and it is persisting. The patient states it's not worsening, she just feels it sometimes then it goes away if she massage it or applies pain ointment.Chest Pain: The patient states her chest is painful, the left side of her chest is very painful. The patient states she doesn't like to receive it because she said she might be allergic because sometimes she's really allergic, but all her friends said she needs to go now, she will be protected and of course she knows that like from the flu vaccine so she searched before she was able to see and she was going to get Moderna so she said she would look for a nearer place near her and so her friend told her to go to pharmacy because she has friends there that would help her and she went there and she got the Pfizer vaccine. The patient states that's because she did not have the pain before that for a long time for many years and now after getting the vaccine, now, she experienced it. All of the events were assessed as Medically significant. The adverse events did not require a visit to Emergency Room or Physician Office.Prior Vaccinations (within 4 weeks), there was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The reporter considered the events were all related to Pfizer Covid 19 Vaccine. The outcome of the event was Numbness of upper extremities was not recovered ,the others was Recovering. The information on the batch number has been requested.; Sender's Comments: Based on the information provided and temporal association, a causal association between suspect drug and 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 RAs, Ethics Committees, and Investigators, as appropriate.

Received Pfizer vaccines on 2/19/21, 3/16/21. Tested positive for COVID-19 on 7/10/21. Symptoms began on 7/6/21 w/ cough, dysgeusia, fatigue. Hospitalized on 7/13/21; transferred to ICU on 7/22/21. Patient expired on 7/25/21 due to pneumonia d/t COVID-19. Patient was intubated; given dexamethasone 6 mg x9 d, 5 day course of remdesivir, one dose of tocilizumab for COVID pneumonia. PMH significant for past medical history significant for pulmonary sarcoidosis, on prednisone 5 mg daily; immune thrombocytopenic purpura, on rituximab.

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.

Confirmed DVT in the left leg; COVID test (PCR swab): positive on 26Dec2020; COVID test (PCR swab): positive on 26Dec2020; This is a spontaneous report from a contactable other healthcare professional. An 85-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELO140, expiration date: Mar2021), via an unspecified route of administration in arm (deltoid; unknown side) on 23Dec2020 at single dose for Covid-19 immunisation. Medical history included type 2 diabetes mellitus from 2017 and ongoing, high blood pressure from 2017 and ongoing, atrial fibrillation (A-Fib) from 2019 and ongoing. The patient's concomitant medications were not reported. The patient was administered first dose of the COVID vaccine on 23Dec2020 and then was swabbed for COVID on 26Dec2020, and then on 28Dec2020 her PCR swab was positive for COVID. She was asymptomatic until she started complaining of leg pain. She ordered an ultrasound for the patient on 30Dec2020, and it confirmed a deep vein thrombosis (DVT) in left leg. The patient was being treated with anticoagulant apixaban (ELIQUIS) currently. Caller stated that this could be that it (DVT) is from COVID, but her real question was, could it be from the vaccine? In Pfizer's information packet for patients, there is section on what to tell your provider prior to getting vaccinated. One of the things on there is if you have a bleeding disorder or are on an anticoagulant. There is no explanation as to why it was in the packet of information. Caller has looked everywhere and can not figure out why that is on the FAQ/packet information. The patient was due for the second dose on 13Jan2020, but she was worried and hesitant to approve it. The patient underwent lab tests and procedures which included COVID test (PCR swab): positive on 26Dec2020, ultrasound of the left leg: confirmed DVT on 30Dec2020. The outcome of events was not recovered.; Sender's Comments: There is not a reasonable possibility that event "COVID test (PCR swab): positive" is related to BNT162B2 vaccine. The event occurred 3 days after vaccination, when vaccine was not expected to achieve the effect. The event DVT of legs is not considered related to BNT162B2 vaccine. The patient had underlying diabetes and cardiovascular disorders, which are considered as risk factors for DVT. 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.

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

Patient developed fever to 102 within 24 hours with decreased mentation. Stopped eating/drinking despite aggressively treating fever. Was DNR B status. Family agreed to a trial of IV fluids on 1/21 but was not successfully started until 1/22 after several attempts. Family wanted only comfort measures with no transfer to hospital. Patient continued to have fevers to 102-103 range. Patient passed on 1/23 . Patient did test positive for COVID in early September without significant illness. She was in usual state of health prior to vaccination.

patient received vaccine on Jan 23, 2021. developed weakness on Jan 25, 2021. Sent to ED on Jan 27, 2021 with hypoxia requiring 6 L O2, low Bp, declining mental status. Per family request transitioned to hospice and passed away on Jan 30, 2021

Xrays showed covid Poss pockets all in her lungs on 15Jan; Xrays showed covid Poss pockets all in her lungs on 15Jan; This is a spontaneous report from a contactable consumer. An 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. Medical history included dementia. Concomitant medications were not reported. Patient popped hot 02Jan2021 along with 4 others on the hall she lived. Within 9 days 50+ patients were positive. All had the vaccine the same day. Patient was test positive on 02Jan2021. She was on day 12 of her quarantine when she started to get worse. She was unresponsive by 16Jan2021 and passed 18Jan2021. We were with her from 14Jan2021 to 18Jan2021. But had not been allowed to visit with her since Mar2020. And what post treatment pairs well with it? Publicly we hear Remdesivir and Bamlanivimab but these patients only received a general antibiotic and some vitamins. Death cause was Xrays showed covid Poss pockets all in her lungs on 15Jan2021. No autopsy was performed. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information; Reported Cause(s) of Death: Xrays showed covid Poss pockets all in her lungs on 15Jan

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.

I got the vaccine at 8 AM that morning and I was fine until about 5PM and I got very cold. I was freezing. I had a chill. I checked my temperature and it was around 99-100. During the night I woke up with a bad chill, I was really cold and I was shaking really bad. I checked my temperature and it was 102. Tuesday I checked my temperature all day it never went over 102. I took Ibuprofen all the day, no more then 4 tablets. I took a nap in the afternoon for about 2 hours and I when I woke up I was really cold and I was freezing and shaking. I was so cold my teeth were chattering. My mouth was very dry, I tried to drank a sip of water, which made me nauseous and I throw up slightly. My husband was concerned because he couldn't get me warm and he called our son. Our son came over, and asked do I know who he is and I responded no. I have reconciliation of my son coming over or my husband calling our son over to come check on me. My son immediately to called 911, EMS arrived and they transported me to hospital. I do not remember any of this, I didn't become appear until I was stretcher , at that point I became aware and knew the answers to the questions being asked but I couldn't respond. I remember hearing the EMT say to turn the air on, I was burning up and had a temperature of 105. I was transported to Medical Center. They run a lot of tests and they were trying to get my fever down. Sometime late that night they were finally able to my temperature down. I was released about 10 AM on Wednesday morning. I have been fine since then. The doctors who all seen me in the ER all said they have not seen anything like this.

"Patient with a PMH of HTN, Afib RVR (on Eliquis), nonischemic CMO, HFrEF (EF 25%), HLD, HLD, Fe deficiency anemia, Pulmonary HTN, rectus sheath hematoma presented to ED with LUE edema and pain that started a couple of hours after second dose of COVID vaccine adminstration. Patient had received COVID vaccine shortly after noon day prior to admit on RUE. She reports that she had been experiencing some nausea as well. She was admitted to the hospital for overnight observation secondary to transient alteration of awareness after she presented to the ED for arm swelling where experienced a syncopal episode lasting approximately 1 minute. She was monitored on cardiac tele which showed Afib with appropriate rate control overnight. For her left upper extremity swelling an U/S was done which was negative for thrombus, only a hematoma. Her arm pain was controlled and supportive with a compress. Patient had no further syncope, Afib rate controlled, and hemodynamically stable. Discharged home 2/24/21.

Presented to ED 48 h after vaccine with chest pain, found to have pericarditis Develop atrial fibrillation, nSTEMI from demand ischemia

2/9/2021 Expired at facility. Several weeks prior with several medical and mental health issues as noted prior. 2/4 began with increased lethargy and somnolence. Medications being held per MD. 2/5 CBC WNL, BUN/Cr 38/1.23 GFR 41 2/5 Admitted to Hospice services on 2/5.

Patient found unresponsive approx 16 hours after vaccination. Death listed as Cardiac arrest secondary to stenosis. Patient had inoperable cardiac issues and was reportedly in a terminal state.

Pt tested positive for COVID on 02/29/2021. Passed away on 02/25/2021. COVID listed on death certificate.

2nd injection given on 02/16/2021 Altered Mental Status admission on 3/3/2021 Intracranial bleeding Unresponsive Intracranial bleed Death on 3/6/2021

Mini Stroke. Could not talk for 2 minutes then jumbled sentences. next day tired but improved. Following day just tired. No long term symptoms

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.

I do have Atrial fibrillation but I have never had it go on continuously for 5 days; fast heartbeat; fast heartbeat; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 17Feb2021 (Lot Number: Unknown) as SINGLE DOSE for COVID-19 immunisation. Medical history included atrial fibrillation and rapid heart rate from an unknown date and unknown if ongoing. Concomitant medication included apixaban (ELIQUIS) and sotalol; both taken for atrial fibrillation, start and stop date were not reported. For 5 days, the patient had a fast heartbeat from 01Mar2021 but now she is okay. On 01Mar2021, the patient stated "I do have the atrial fibrillation but I have never had it go on continuously for 5 days before The patient was feeling better now. The outcome of the events was recovered on unspecified date. Information on the lot/batch number has been requested.

Atrial fibrillation; heart rate was erratic, but not as much as yesterday and today.; Her blood sugar is steady in 160s where it is normally lower in the 120s, 130s, and 140s.; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received second dose bnt162b2 (BNT162B2, Solution for injection) via an unspecified route of administration on 20Feb2021 (Batch/Lot Number: EL9266; Expiration Date: 31May2021) as single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus, thyroid, ongoing bone strength. Concomitant medications included ongoing insulin lispro (HUMALOG) (over 150 take two units) for Diabetes, ongoing insulin (30 units of insulin) taken for diabetes, ongoing levothyroxine sodium (SYNTHROID) (25mcg one tablet in the morning) taken for thyroid, ongoing Lisinopril (40mg one in the morning) for Blood pressure and ongoing Nifidepine (90 mg two and half hours after lisinopril) for blood pressure abnormal, ongoing Atorvastatin (one 20mg tablet at night), ongoing colecalciferol (D3) (25mcg one in the morning), cyanocobalamin (VITAMIN B12) (1,000mcg time release in the morning), Magnesium oxide at 400mg, ongoing calcium carbonate, colecalciferol (CALTRATE 600+D3) taken for bone strength. Historical vaccine included BNT162B2 (30mcg/0.3mL, lot: EL9265, expiration: 31May2021) on 30Jan2021 at 85 years for Covid-19 immunization. It was reported that, she has not had any problems. She goes to the doctor regularly. She has an apple watch, and she does check her heart. She also walks and tracks her steps. The last two weeks, she has noticed something knew. She has developed atrial fibrillation on an unspecified date in Feb 2021. She was concerned. She will do whatever her doctor suggests. She has read that two of the side effects are blood clots and t cells and a changing heart. She has not had atrial fibrillation in the past. She does check her heart. It was just something she does. She has had heart tests before. They checked her out last year 2020. On an unspecified date in 2020, they did a stress test and everything was fine. Everything was fine until last week. Everything was normal before that. The atrial fibrillation started last week. She decided to wait another week to see what happened. Then yesterday, the atrial fibrillation started again with all sort of swiggles. Her watch shows afib or inconsistency. It has been off the wall yesterday and today. She didn't have a prescribing doctor. The health department put up a screen on their website for people 80 and over so she signed up. She goes to the doctor this Thursday. She has diabetes, but it was under control. She takes insulin and Humalog for extra coverage. Her blood sugars have steadily been higher than normal. She took her heart rate on and off last week. It was over a couple of days. Her heart rate was erratic, but not as much as yesterday and today on an unspecified date in Feb2021. Her blood sugar was steady in 160s where it was normally lower in the 120s, 130s, and 140s on an unspecified date in Feb2021. The outcome was not recovered for atrial fibrillation, and unknown for erratic heart rate and blood sugar levels increased. No follow-up attempts are possible. No further information is expected.

Vaccine 12/25, 1/19. admitted 2/18, tested COVID+ with PNA. Treated w/abx, dexa and convalescent plasma. DCd back to NH.

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

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

Patient had underlying b cell lymphocytosis after 2nd dose of Pfizer Vaccine, patient developed autoimmune hemolytic anemia and shortly after developed a pulmonary embolism.

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.

The day after first shot , patient was more paranoid, increase hallucinations, angry and started to lose ability to stand up straight, by day 8 she had total loss of leg control and torso, could not feed herself, dress herself and she was very combative and hallucinating constantly. We had to hospitalize her and she died March 6 in the hospital.

Patient had a stroke on March 15, 2021 as described as a blood clot in her brain. Medical personnel were unable to correct it surgically and she passed away that evening in the hospital. Death was the final result.

Heart stopped (15Feb2021) day after second shot; coma; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration (at the age of 85-years-old), administered in Arm Right on 14Feb2021 12:00 (Lot Number: E9262) as single dose for COVID-19 immunisation. Medical history included Distal dystrophy, allergies to Sulfur. The patient was not pregnant. The patient was not diagnosed with COVID prior vaccination. Concomitant medication included citalopram, levothyroxine, vitamin D3; all taken for unspecified indications, start and stop dates were not reported. The patient previously took Plaquenil [hydroxychloroquine phosphate] and experienced allergies. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 85-years-old), administered in Arm Right on an unspecified date (Lot Number: E9269) as single dose for COVID-19 immunisation. The patient's heart stopped (15Feb2021, 04:00 PM) on the day after second shot. In ICU, induced into coma, hospitalized 6 weeks. No history of heart problems, "had EKG several weeks before 1st shot\ -v was normal." Still under doctors' care. The patient underwent lab tests and procedures which included electrocardiogram: normal on an unspecified date. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for the events for 42 days. Therapeutic measures were taken as a result of the events which included "Coded 2x, Incubated, induced coma, pacemaker." The outcome of the events was recovering. No other vaccine in four weeks. The patient was not tested for COVID post vaccination.

This 85 year old white female received the Pfizer Covid shot on 1/26 /21 and went to the ED on 1/31/21 and was admitted on 1/31/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) (CMS/HCC) I63.9 - Stroke determined by clinical assessment (CMS/HCC) R29.810 - Facial weakness

blood clot it is from my hip all the way down to my left leg to my ankle; blood clot but it is the big one from my hip all the way down to my foot; foot going down the swelling went up to my leg/foot and my leg is swelled my toes all over up to my leg swelled; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0162), via an unspecified route of administration, administered in left upper arm on 10Apr2021 at the age of 85-years-old as single dose for COVID-19 immunization. The patient's medical history included ongoing arthritis and ongoing chronic obstructive pulmonary disease (COPD). The patient reported that she was not taking anything for arthritis, just some Tylenol once in a while over the counter (it was not prescription). The patient was taking an inhaler for COPD. The patient was taking unspecified concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ER2613), administered in left upper arm on 20Mar2021 at the age of 85-years-old for COVID-19 immunization and experienced bladder infection and viral infection. The patient got the first Pfizer vaccine on 20Mar2021 and was alright for a few days afterwards. Then all of a sudden, she started getting infections on 28Mar2021, 8 days after she had the first vaccine. She got a real bad bladder infection then she went to the doctor and she got medication for that. She was with bladder infection then she came down with the viral infection. The patient reported that she has not even been going anywhere because of the virus and she has been staying home. She just goes to the grocery store and clinic to the doctor, that was it. The patient had an antibiotic for the bladder infection. Sulfamethoxazole was the name of the medication that was for bladder infection. They didn't give the medication for the viral infection. The patient reported that it was just a viral infection, it was not the Covid. Since then, she had her second dose of the vaccine on 10Apr2021 and from an unspecified date in 2021, her foot started, her foot swelled up and she didn't know. She takes lot of retention pills, so she thought maybe it was that. So she took her pills and everything and washed and start getting but the next day instead of the foot going down, the swelling went up to her leg and then the next day it went all away up to her hip. The swelling on the left side from the foot all away up to the hip. She went to urgent care on 21Apr2021 (reported as "21st") and saw a doctor and she was tested and she had blood clots. Regarding lab test, the patient reported she had two infections and then she got the blood clot that was from her hip all the way down to her left leg to her ankle. She could not figure out that they called the test and what they tested. But they had a lab work done then one has a test, veins, and everything. She can't remember. The patient reported that her foot and her leg was swelled, her toes all over up to her leg swelled. She had a fat foot and a fat leg just one side. She would say since she has started taking medicines for that, she took the first dose at the evening of 21st (21Apr2021), the day she went to the urgent care, and she would say it was not any worse. The medication was supposed to break up the blood clot, but it was the big one from her hip all the way down to her foot. Just a little bit better. The outcome of the events was recovering.

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

DIAGNOSIS at time of disposition: 1. COVID-19 virus detected 2. Fall, initial encounter 3. Traumatic rhabdomyolysis, initial encounter (HCC) 4. Hypothermia, initial encounter 5. Atrial fibrillation with rapid ventricular response (HCC) 6. Pneumonia due to COVID-19 virus

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.

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

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

Participated in skilled therapy, continued visits w/oncologist, vaccine requested and administered, continued skilled therapy w/decrease in strength as what brought resident to SNF w/RLE cellulits w/MRSA, Vaccine series completed, continued skilled therapy, WBCs chronically elevated per oncologist as expected may occur w/cancer tx med for active leukemia. Continued decline overall w/decline in intake of food and fluids, hospice care initiated. Over the course of months, resident declined to bedrest w/expiration 5/24/21.

Inoculated woman spoke words that made no sense, backed her car through the closed garage door, did not respond to stroke questions, was taken to hospital by ambulance, had an MRI, and was diagnosed with a blood clot in her brain. The blood clot was removed; speech therapy was required.

headaches; muscle aches; pains; chills; other flu-like symptoms; Hard of hearing; Kind of stiff; Little bit of discomfort; Trouble in seeing; I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it.; Skin dry; This is a spontaneous report from a contactable consumer or other non-HCP (patient). An 85-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Feb2021 (age at the time of vaccination 85-years-old), as single dose for COVID-19 immunization. The patient's medical history included Hypertension, Stroke, Heart attack, and on an unspecified date Aug2020, Covid-19, I actually had a mild case of COVID. The patient's concomitant medication included Isosorbide, Losartan, and Cartia Xt (Diltiazem Hydrochloride). On an unspecified date, the patient experienced headaches, muscle aches, pains, chills, other flu-like symptoms, Hard of hearing, Kind of stiff, Little bit of discomfort, Trouble in seeing, I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it, and Skin dry. On an unspecified date Aug2020, the patient underwent lab tests and procedures which included Covid-19: positive, I actually had a mild case of COVID. The outcome for all the events was unknown. No follow-up attempts are needed. No further information is expected.

She had the first dose of Pfizer vaccine at the Campus on Friday 1/15 at 4:30 pm. After the vaccine, she had no new symptoms or signs of vaccine reaction and MD friend reports that he checked her pulse which was not elevated from baseline. On 1/16, she awakened and continued to feel at her recent baseline. However, in the early afternoon, she complained of headache, nausea/epigastric pain, and chest heaviness. These apparently were not unusual symptoms for her to feel intermittently. Per her niece, who has a home O2 sat device, her 02 sat that morning was 97 with a HR of 87 irregularly irregular. She was afebrile. (continue on page 2)

1st COVID immunization 1/7/2021, COIVD positive results on 1/16/21, 1/24/21 O2 sats decreased to 78%, 1/24/21 reveived the Bamlanivimab infusion 50 ml/hr. 1/24/20 chest x ray 1/24/21 She was sent to hospital and admitted. 1/27/2021 Expired

volvulus; volvulus and needed surgery followed by further ischemia; This is a spontaneous report from a contactable physician. An 86-year-old female patient received her first single dose of BNT162B2 (Pfizer-BioNTech Covid-19 vaccine) intramuscularly on 19Jan2021 for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient developed volvulus and needed surgery followed by further ischemia and at end of life. The events onset date reported as 27Jan2021. Patient had 3days hospitalization and died eventually. It was unknown if an autopsy was performed. Information about lot/batch number has been requested.; Sender's Comments: Very limited information was provided in this report. No relevant information regarding the clinical course of the events, the patient's underlying medical conditions were mentioned. Based on the information currently available, lacking any other alternative explanations as so far, the reported volvulus and Intestinal ischaemia are managed as related to COVID-19 vaccine, BNT162B2, for reporting purpose, only. 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 RA, IEC, as appropriate.; Reported Cause(s) of Death: volvulus; ischemia

Patient received her vaccine on 01/25/2021. Two days later, she presented with an acute right MCA stroke with aphasia.

Per report from family member illness started with fever, chills and increasingly progressed to needing emergency care

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.

bowel perforation; pain in her upper abdomen; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 13Jan2021 for Covid-19 immunisation, administerd at nursing home/senior living facility Medical history included dementia, arthritis. No known allergies. Patient was not pregnant. Patient had not COVID prior vaccination. Concomitant medication in 2 weeks included: memantine (manufacturer unknown) 10 mg BID, diclofenac (manufacturer unknown) BID, carbidopa, levodopa (manufacturer unknown) 25-100 mg TID, quetiapine (manufacturer unknown) 12.5 mg q HS, escitalopram oxalate (LEXAPRO) 10 mg q HS, paracetamol (TYLENOL) 650 mg BID, glucosamine (manufacturer unknown) drink. The patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 24Dec2020 for Covid-19 immunisation. No other vaccine received in 4 weeks. The patient experienced bowel perforation and pain in her upper abdomen on 18Jan2021 07:30. The events resulted in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event), and death. On 18Jan2021 07:30 AM, less than a week after the second shot, she had pain in her upper abdomen and was taken to the ER on 18Jan2021. CT showed a bowel perforation in the small bowel. She had never had bowel surgery or diverticulitis. She had been healthy other than her dementia and arthritis. Patient received treatment for the events: hospice and pain management. COVID-19 was not tested post vaccination. The cause of death was bowel perforation. An autopsy was not performed. Information about lot/batch number has been requested.; Reported Cause(s) of Death: bowel perforation

Patient received the Pfizer covid19 dose 1 on 1/21,2021, subsequently developed diagnoses by Dr. on 2/4/21, left lower extremity, Dr. authorized the second shot and patient received this on 2/11/21

Numbness in face, legs; Slight headache; Whole chest froze up; It has been an effort to talk, she was really working hard to talk; Muscle tightness around her whole face; Legs weren't steady enough; Didn't feel well; She was very weak; Could only stay awake for very short amounts of time; She never had trouble with her stomach like this before; Lip has a slight droop on left side of her face; Felt like she was having a heart attack; Felt extreme exhaustion; Not able to eat; She thought she has low blood sugar; This is a spontaneous report from a contactable consumer (the patient). An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249, expiration date not reported), via an unspecified route of administration (left arm) on 21Jan2021 14:50 at a single dose for COVID-19 immunization. Medical history includes therapy on her back from the past, from an unknown date. Concomitant medication included melatonin to sleep and, paracetamol (TYLENOL) to sleep. The patient received the first dose of the vaccine on 21Jan2021 at around 2:50 PM, the next morning on 22Jan2021, she felt extreme exhaustion, she'd get up and have to get back to bed, not able to eat, and she thought she has low blood sugar. She got up and had a bowl of cereal. On an unspecified date, the patient also reported numbness in face, legs and slight headache, and need to eat all of a sudden or pass out, and these has gone on for five days now (at time of report). The patient also reported that her lip has a slight droop on left side of her face which was concerning her. The patient reported that after numbness and not eating, she had some ice cream and her whole chest froze up, and it felt like she was having a heart attack. Her chest felt like ice which never had happened before. It has been an effort to talk, she was really working hard to talk. The patient explained she got the vaccine 5 days ago (from the time of report) and reported she had muscle tightness around her whole face, she had a slight droop on the left lip, a slight headache right across the eye brows, her legs feel a little numb off and on, she got feeling of tiredness but that passes, she had the need to go eat suddenly or she will get very weak. The reason for the call was she was wondering if she should she go for the second vaccine when 5 days after having the vaccine she was experiencing numbness. Slight droop on the left lip started but never looked close until the time of report, not a lot but the lower lip on the left side it is slightly droopy, with slight headache right across the eye brows. Her legs felt a little numb off and on, and she stated that about 3 days after the vaccine, she was afraid to take a shower because her legs weren't steady enough. They are still that way at the time of report, but this did go away for a while on a day and she was able to take a shower. She also didn't feel well after the vaccine. On the day of the vaccine, she had a good dinner and felt good; but the next morning she was very weak and could only stay awake for very short amounts of time. She was in bed and couldn't stay up and this is not like her, she did not like to be in the bed. She got the feeling of tiredness but that passes and she can stay up for longer periods of time. She had to go eat or she gets very weak, she didn't feel like eating in the beginning. It was on the 4th day after the vaccine she would have to get a bowl of cereal all of a sudden or she would feel like she was going to pass out. She never had trouble with her stomach like this before where she felt the need to have to go and eat. She explained she never had trouble with stomach, she never had headaches, and never had a vaccine before. Muscle tightness around her whole face started 2 days after getting the vaccine and was getting worse. Her face felt really tight almost numb feeling. The outcome of the events was unknown.

Resident presented with stroke like symptoms on 2/27/21 and was transferred to the emergency room. She was diagnosed with Bell's Palsy and sent back to the facility. Resident received 1st dose of Pfizer vaccine on 1/24/21 and 2nd dose on 2/14/21.

Like I'm having a stroke; neck ache; nightmares; nervousness; Felt terrible with bad headache; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6200) via an unspecified route of administration on 15Feb2021 13:00 at single dose in left arm for COVID-19 immunisation. She received the first dose of BNT162B2 (lot number: EL9262) on 18Jan2021 13:00 in left arm for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was allergic to Formaldehyde, Coumadin. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Feb2021, the patient felt terrible with bad headache. On 18Feb2021 also felt terrible. On 17Feb2021 08:00, Like she was having a stroke. Headache, neck ache, nightmares, nervousness. Blood pressure was ok. Oxygen was ok. Pulse was ok. No treatment received for the adverse events. Events outcome was not recovered.

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.

Patient received vaccine at 10:35am, was observed for 15 minutes then returned home with family. Patient began to not feel well, experienced cardiac arrest as witnessed by son, was taken to hospital Emergency Department where she expired at 12:50pm.

Massive Hemorrhagic stroke 24 hours after receiving first Pfizer vaccination. Suffered bleeding of kidney 6 days later, followed more brain bleeds and blood in stomach area. Vessels are leaking blood, Dr's were could find no reason for the bleedings, have not seen this before.

Abdominal pain, nausea, diarrhea, headache, muscle aches, and fatigue1-2 days after vaccination prompting transport via EMS to ER from home. Had cardiac arrest while in the ER x2, subsequent anoxic brain injury and death following removal of ventilator support.

atrial fibrillation; This is a spontaneous report from a contactable consumer (consumer). An 86-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 14Feb2021 11:00 (at the age of 86-years-old), at single dose for COVID-19 immunisation. Medical history included diabetes and high blood pressure. The patient had also Covid prior vaccination. The patient had no known allergy. Concomitant medications included linagliptin (TRADJENTA), insulin glargine (LANTUS), glimepiride and carvedilol (COREG). The patient experienced atrial fibrillation on 15Feb2021 at 15:00. The patient visit emergency room and was hospitalized for 1 days. The event was treated with antiarrhythmic and anticoagulant drugs. The outcome of event was recovering. Information on the lot/batch number has been requested.

Admit 2/19. Vaccinated 1/3, 1/28. Per notes tested + Jan 2021. Admit for hypoxia and PNA, difficult to determine if COVID related. Treated w.abx. DCd to Rehab.

The daughter of the patient stated that her mother is a cardiac patient and has a stent. The patient always has edemas on her legs but the day after the vaccination she observed edema and report pain on the left thigh. The following Monday she visited the MD and he order a venous Doppler. The result was a thrombosis on the right leg . The patient was put on medication (Xarelto)

Patient was found deceased by her son 2 days following vaccination. Coroner stated heart attack was the likely cause of death. However, a autopsy was not performed before the body was cremated.

02/03/2021 EXPERIENCING CHEST PAINS. 911 CALLED. TRANSPORTED TO HOSPITAL . ALL HEART TESTS (ECHO, BLOOD TEST) CAME BACK NORMAL. CHEST XRAY SHOWED CONGESTIVE HEART FAILURE AND ADMITTED TO HOSPITAL TO REDUCE SWELLING IN LEGS 02/03/2021 EVENING. HOSPITAL DR'S STARTED 80MG LASIX BY IV. DISCHARGED 02/05/2021 @ 12:00PM. TOOK HOME - PASSED OUT X4 BEFORE CALLING 911 AGAIN. TRANSPORTED BACK TO SAME HOSPITAL. ER DR. ASKED IF POSSIBLE FOR HER TO LOOSE 21.6 LBS IN LESS THAN 48 HRS. RE-ADMITTED INTO HOSPITAL 02/05/2021 @ APPROX 9:30PM FOR RE-HYDRATION ORALLY. DISCHARGED 02/10/2021

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

received vaccine on 01/20/21. 02/06/21vomiting, difficulty eating, hypotension, sent to hospital and admitted with hypotension and hypothermia, placed on Bi-pap, 02/15/21 resident returned to facility under hospice care, expired on 02/24/2021

Diarrhea; Vomiting; Weak; Found Slumped Against the Wall; Low Potassium; MRI Found Multiple Small Emboli in Brain; thrown more clots; Aphasia; Difficulty Walking; potassium dropped and she went into A-Fib and threw clots; potassium dropped and she went into A-Fib and threw clots; has problems with recent memories; confusion; food sensitivities; This is a spontaneous report from a contactable physician (patient's daughter). An 86-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 86-years-old, via an unspecified route of administration on 24Mar2021 at 14:00 at single dose for COVID-19 immunization. Medical history included high blood pressure diagnosed in 1971 (reported as 50 years ago) and ongoing; type 2 diabetes in 2011 (reported as 10 years ago) which resolved in 2019 (about 2 years ago) after the patient lost some weight; she had an episode of A-Fib in 2019 when her potassium was low (lower than the current hospitalization), once the potassium was corrected, her A-Fib resolved. The physician stated that patient has shrunk and was now about 5 foot 2 inches. Clarified that this has not recently occurred since the vaccine; stated it was happening just with age. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not have any issues with the first dose of the vaccine. She received her second vaccine dose on 24Mar2021. The physician spoke with the patient on Friday, 26Mar2021, and the patient was fine. On Saturday, 27Mar2021, the patient had an episode of diarrhea, vomiting and was weak. The lady cleaning the patient's house found her slumped against the wall. The physician met them at the hospital and said the patient seemed okay. They thought it was just an issue from her potassium being low on Mar2021, so they gave her that. The hospital did a CT scan that showed nothing on Mar2021. The hospital did an MRI of the head that showed multiple small emboli in the brain on Mar2021. The physician believed that the patient must have thrown more clots because she became aphasic on Mar2021 and could not name things. The patient also had difficulty walking on Mar2021. The physician felt it was important to call and report this since she has heard of people throwing clots with vaccines. The physician did not know if the events were related to the vaccine. The patient was in the hospital for 7 days (as reported). She was now able to walk with some assistance. The patient's son thought that the patient was okay when he went to see her. Since the reporter was a physician, she knew which questions to ask the patient and saw that she still had some problems. The patient could remember some things but has problems with recent memories on an unspecified date in 2021. She also has some confusion on an unspecified date in 2021, such as she thought she was in a boat hospital. The physician was uncertain if the vomiting and diarrhea was somewhat better. They were wondering if the patient has some food sensitivities (2021). The patient also had carotid studies done in the hospital on Mar2021 and they were fine. They believed that patient's potassium dropped, and she went into A-Fib and threw clots on Mar2021. The clots must have come from the heart valves since the carotid studies were fine and if the clots had been in her legs, they would've gone to her lungs not to her brain. The patient underwent lab tests and procedures which included CT scan: negative, potassium: low, carotid studies: fine, MRI of the head: multiple small emboli in brain, all on Mar2021; and potassium: low, height: 5 foot 2 inches (shrunk), and weight: lost, all on an unspecified date. The events diarrhea, vomiting, weakness and fall required emergency room visit. The outcome of the event difficult walking was recovering and unknown for all other events. The events diarrhea, vomiting, weakness, fall, potassium low, cerebral embolism, thrombosis, and "potassium dropped and she went into A-Fib and threw clots" were assessed as serious due to hospitalization and being life threatening; and the events aphasia and gait disturbance were assessed as serious due to hospitalization. All other events were non-serious. The patient was hospitalized from 27Mar2021 until 02Apr2021. Information about the lot/batch number has been requested.

She had a stroke caused by blood clot in brain. Suffered a second stroke 4 weeks later. Has weakness left leg. Is now in Rehab Center

My mother was found unconscious on the kitchen floor. She was taken to the hospital. She had different test including a Cardiac stress test and it was found to be okay. However, my mother developed a blood clot in her left leg. She still been under medical observation in the hospital.

Patient had 1st Pfizer vaccine on 3/13/21. She states she went to ER on 3/19/21 and was found to have a blood clot behind her left knee (found by ultrasound). She was put on Eliquis. Patient had 2nd Pfizer vaccine on 4/3/21. Patient did not mention blood clot at time of 2nd vaccine. Patient was admitted to hospital on 4/13/21 for stroke. It was attributed to bleeding in brain and patient was taken off Eliquis and put on a new blood thinner. She will be discharged on 4/20/21 to rehab.

4/21/21 ER hpi: 86 y.o. female who presents with unresponsive episode. Patient is a resident of a nursing home and was apparently talking to members of her family when she collapsed prior to arrival several minutes ago. Paramedics report patient hypotensive on arrival to scene. Blood pressure and level of consciousness have improved during transport. Patient is hypertensive and is on multiple medications. At this time she has no complaints and states she feels all right. She does have a history of multiple recurrent urinary tract infections. Admitted observation to hospital 4/21/21 dx syncope and collapse, positive d-dimer, acute uti

This 86 year old female received the Covid shot on 2/07/21 and went to the ED on 2/12/21 and was admitted on 2/13/21 with a cerebrovascualar accident, weakness, encephalopathy and UTI and went to the ED a 2nd time on 2/24/21 and admitted on 2/26/21 with and went to the ED again on 3/22/21 with altered mental status and died in 4/2021. 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.

Patient tested positive for COVID back in December 2020. She passed away at the nursing home facility on April 1, 2021.

Patient with no reported past medical history or past surgical history presented to ED and found to have massive bilateral pulmonary embolism. Upon presentation, patient was confused and lethargic. The morning of the event, niece reports that patient was in her usual state of health this am and had gone downstairs to the kitchen this afternoon, when she was downstairs she began complaining of nausea and generalized back pain. Her niece went to grab her things to take patient to the hospital but when she returned she found the patient laying on the floor due to weakness and pain, no reported fall or trauma. Chest/Abd/Pelvis CT Angio was significant for large PE in R and L main pulmonary arteries. No family history of DVT/PE.

Same day as when patient received the 2nd vaccine, she was overcome with generalized fatigue and nausea. By the 4th day, her legs would not hold her when she tried to stand getting out of bed. She was nauseous to the point of not being able to eat or drink. Infact, she did not have the strength or desire to eat or drink. By the 5th day post vaccine (02/20/21), I took her to the Emergency room because she was so fatigued, she just slept, and couldn't stay awake to eat or drink. She was able to get to the car with a walker, but that was the last time she walked. After time at hospital and then Skilled nursing, she passed away on 03/21/21. She never regained the ability to toilet herself, eat on her own, failed to eat and drink, and eventually was put on hospice because she lost 30 pounds over the month from failure to eat or drink, even though I was there or the nurse was there to feed her every meal, and try to get her to take fluids. Her fatigue was just overwhelming. When she first arrived at the emergency room, she: ? Presented with 2 days of weakness and AMS; fever, nausea and generalized fatigue ? Word finding difficulty; without stroke or acute abnormal on CT or MRI; according to the Hospital

J18.9 - Pneumonia I95.9 - Hypotension R09.02 - Hypoxia I48.91 - Atrial fibrillation with rapid ventricular response (CMS/HCC) A41.9 - Sepsis, unspecified organism

Patient was admitted to the emergency room the morning after receiving the vaccine and died on 07Apr2021; Nasal swab Positive; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) (at the age of 86 years old) as single dose for COVID-19 immunization. Medical history included gastro-intestinal problem. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was admitted to the emergency room on 31Mar2021 the morning after receiving the vaccine. The patient was hospitalized for two days. It was unknown if treatment was given. This event (Patient was admitted to the emergency room the morning after receiving the vaccine and died on 07Apr2021) resulted in emergency room/department or urgent care, hospitalization and life threatening illness (immediate risk of death from the event) and patient died. The patient died on 07Apr2021. The patient's nasal swab was positive on 31Mar2021. The outcome of the event nasal swab was positive was unknown. It was not reported if an autopsy was performed. Information on batch/lot number has been requested.; Reported Cause(s) of Death: Patient was admitted to the emergency room the morning after receiving the vaccine and died on 07Apr2021

This 86 year old female received the Covid shot on 3/10/21 and went to the ED and admitted on 3/12/21 with the following diagnoses listed below. J18.9 - Pneumonia, unspecified organism D69.6 - Thrombocytopenia, unspecified Altered Mental Status

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.

blood clot; Sciatica; She then got sciatica in her leg and couldn't walk; charley horse in her lower leg while walking; soreness in arm / pain in her foot / lower leg/calf still hurt; This is a spontaneous report from a contactable nurse (patient). This 86 years old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6203) on 04Mar2021 at 11:00, in left arm, for COVID-19 immunisation. No other vaccines were administered on the same date. The patient received the first dose of BNT162B2 vaccine intramuscular, on 11Feb2021 at 18:30 (lot EN6201). The patient received some years ago an unspecified pneumonia vaccine and an unspecified tetanus vaccine experiencing after both headache, swollen arm and rash. She didn't react to the flu vaccine. Her body didn't want any more vaccine. Concomitant medications were none. On an unspecified date in Mar2021, maybe a week or two after the second vaccination, early to mid afternoon, the patient had what felt like a charley horse in her lower leg while walking, but didn't pay any attention to it, just put ice on the leg. She then got sciatica in her leg on 24Apr2021 and couldn't walk; that was what sent her to the hospital as it was getting worse and she went to the hospital because of the pain. She just ignored it for at least a week but she was still having pain after the second week and could hardly walk due to the sciatica in that leg. At the hospital they found she had a blood clot in the calf of her leg on 28Apr2021. She was hospitalized from 28Apr2021 to 02May2021. The doctors in the hospital recommended that she should report her experience even though they didn't know if it was due to the COVID vaccine due to the proximity. The hospital doctors took care of her but her primary care provider knew that she had been in the hospital. The doctors gave her medications in the hospital that helped the pain in her foot and the sciatica but her lower leg/calf still hurt so they decided to do an ultrasound and found a blood clot. The patient still had to give herself injections in the belly for blood thinner to treat the blood clot. The patient also experienced soreness in arm on an unspecified date in 2021. Sciatica required ER visit. Blood clot was resolving. The other events outcome was unknown. The doctor said that there was a possibility that the blood clot could be related to the COVID vaccine, but it may not be related at all.; Sender's Comments: Based on the information provided by the reporter, including a prolonged onset latency of nearly two months, it appears unlikely that BNT162B2 contributed to the reported events. These are likely intercurrent medical conditions in this elderly patient. This case will be reassessed upon receipt of additional 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.,Linked Report(s) :PFIZER INC-2021501847 same patient/drug, different vaccine dose/AE

Onset acute blood loss due to internal bleeding on approximately 05/09/21, upper GI bleeding and anemia. Hemoglobin dropped to 5.2 resulting in death. Hospitalization on 05/12/21 discharged to Hospice Care 05/15/21 loss of life on 05/22/21.

Bilateral deep vein thrombosis in both legs.; This is a spontaneous report from a non-contactable consumer (patient). An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 03Apr2021 10:00 AM (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included hypothyroid, high bp, urinary bladder cancer, lung cancer, covid-19. No Known allergies. Patient is not pregnant. The patient's concomitant medications were not reported. No other vaccine in four weeks. Patient previously received the first dose of BNT162B2 on 13Mar2021 10:00 AM (at 86 years old) into left arm for Covid-19 immunisation. The patient experienced bilateral deep vein thrombosis in both legs (hospitalization) on 14Apr2021. The patient was hospitalized for 2 days. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. covid was not tested post vaccination. Treatment received for the event included Xarelto. Outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

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.

Patient hospitalized after testing positive for COVID-19. Patient died. Patient was fully vaccinated.

Daughter stated that patient got very weak about a week after the 2nd dose of pfizer vaccine. Daughter also stated that patient was taken to ER bc she was unresponsive and her blood pressure was dropping, patient passed at ER on 05/19/2021

Developed a blood clot in her leg after receiving the first dose of vaccine on 23Jan2021; High blood pressure/ Blood pressure up; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 23Jan2021 11:00 (age at vaccination was 86 years) (Batch/Lot Number: EL9261) as dose 1, single for covid-19 immunization. Medical history included ongoing Difficulty sleeping since 10 to 20 years, osteoarthritis and osteoporosis probably since 20 years or more, hip arthroplasty or replacement when she was 64 years old, Hip revision when she was 83 or 84 years old, she wore out the ball in her hip. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included trazodone (TRAZODONE) taken for insomnia. The patient experienced developed a blood clot in her leg after receiving the first dose of vaccine on 23Jan2021 on an unspecified date in 2021 and taking Eliquis, she took it for 90 days. She said she was doing better, she now had high blood pressure. They first noticed the high blood pressure when she had her ultrasound for her blood clot. It was in the 170s, but now she was on blood pressure medication taking Losartan 100mg, Metoprolol 25mg. Her blood pressure reading this morning (25Jun2021) was 152/83. Her blood pressure reading in 08Sep2020 was 126/84. The events led to the emergency room. She had been seeing her doctor as well. The patient underwent lab tests and procedures which included blood pressure measurement: 126/84 on 08Sep2020, blood pressure measurement: 170s on unspecified date in 2021, blood pressure measurement: 152/83 on 25Jun2021, ultrasound doppler: blood clot in vein on an unspecified date in 2021. The patient received treatment for the events. The event blood clot in her leg was always serious and medically significant. The outcome of the event blood clot in her leg was unknown and other events was recovering.

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. "

Death occurred 3 days after vaccine receipt; attributed to complications of her chronic advanced dementia with aspiration at age 87. No evidence of acute vaccine reaction.

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.

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 was an 87 y/o female admitted for septic shock. She was started on and eventually maxed on 3 pressors. CT abd showed colonic obstruction with dilatation of large and small bowel. Patient was made DNR in the ED. Palliative care consulted on case. Family opted for comfort care. Patient was asystole on monitor. No spontaneous breath/cardiac sounds ausculted. Patient did not withdraw to pain. Pupils fixed and dilated. She was pronounced and 1230 on 1/28/21

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.

she was hurting at her chest/ Chest pain; on her left arm hurt real bad that's what the clot on her left arm; on her left arm hurt real bad that's what the clot on her left arm; She passed away; heart attack; This is a spontaneous report from a contactable consumer. An 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus, for which she was taking a pill like an hour before she would take her meal. On Monday (Jan2021) the patient experienced was hurting at her chest/ chest pain, her left arm hurt real bad as she had a blockage in her left arm/clot on her left arm, and they wanted to put in a stent and after the surgery it went well and she all go home in two days. The patient was hospitalized in Jan2021 due to the events. She had a heart attack and that the chamber between the dividers had a hole in it and her heart tissue was too thin so much thin she couldn't repair it. The patient passed away on 26Jan2021. The patient was tested negative for COVID-19 on unknown date. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: She passed away

Unsure if related to vaccine, but wanted to report event of death due to brain bleed on evening of administration of the vaccination.

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.

Three days after second COVID-19 vaccine, patient became lethargic. Due to advance directive that instructed that no life saving interventions to take place, patient continued to decline and expired on 29 January 2021.

right middle cerebral stroke due to clot in brain; right middle cerebral stroke due to clot in brain; This is a spontaneous report from a contactable consumer or other non hcp. A 87-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL9265), via an unspecified route of administration right arm single dose on 30Jan2021 15:00 for covid-19 immunisation. First dose was received on 09Jan2021 03:00 PM, right arm, lot # EK9231. Medical history included diabetes mellitus, hypertension, hyperthyroidism, glaucoma, drug allergy (to Sulfites). The patient's concomitant medications were not reported. The patient experienced right middle cerebral stroke due to clot in brain from 31Jan2021. The patient was hospitalized from 31Jan2021 to 01Feb2021. The events outcome was not recovered.

2/13/21 Patient had covid like symptoms 2/15/21 Patient admitted to Hospital with covid like sx and decreased O2 sat; tested positive for Covid on 2/15/21; treated with Remdesivir and convalesent Plasma. Sx worsened and patient died 2/26/21..

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.

Pt experienced syncope and collapse, was admitted for pericardial effusion without cardiac tamponade. Treated for suspected inflammatory pericardial effusion with colchicine 0.6 mg daily for 3 months, ibuprofen 600 mg 3 times daily for two weeks. Patient was discharged home from hospital in good condition 2 days after admission, scheduled for follow-up with cardiology. Additionally pt was treated for a scalp laceration from collapse with staples to posterior scalp.

A-fib; AKI (acute kidney injury); AMS (altered mental status); Dehydration; Hyperkalemia; Urinary tract infection without hematuria, site unspecified

Fell twice due to weakness, next day didn't feel good, admitted to hospital, after MRI it was determined a stroke had occurred

Admitted 2/21 for fall at NH, tested COVID+, PNA. Vaccine 1/4, 1/29. Dtr also states pt was COVID + initially 1/18/21. Treated w/zinc and vitamins. DCd back to NH.

Patient received the injection on May 2nd. Following the injection, we noticed an increased weakness and general achiness. On the 8th she was so weak that we purchased a gait belt to assist her. We were not super concerned as we were expecting the second shot to cause body aches or flu like symptoms based on what we had heard from others who had received both vaccine shots. She continued to be unsteady and we found that she has a mild UTI which we had begun treating with prescribed antibiotics. Late afternoon on the 11th, mother suffered a major stroke. we did not take her to the hospital because we had already been told that they would not be able to do anything at her age should she suffer a stroke. On the 12th I called the doctors office and asked for them to send Hospice to the house as we could tell that she was dying. Mother died on the 13th. Just a week prior to her death I had spoken with Dr. and we had discussed how that she was declining in health but that she was not even close to needing Hospice, yet she is dead a week later. Less than 2 weeks after getting her second Covid Shot.

Patient felt ill afterwards, did not regain typical activity level, found deceased in home on day 5 after 2nd dose

Heart attack; sore where the pacemaker was put in; sore at the injection site; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), first dose via an unspecified route of administration, administered in Arm Left on 31Jan2021 14:30 (Batch/Lot Number: PAA156051) as SINGLE DOSE for covid-19 immunization. Medical history included thyroid disorder (reported as thyroid) from an unknown date and unknown if ongoing. It was not provided if there were prior vaccinations (within 4 weeks), if there was any patient's Medical History (including any illness at time of vaccination) and if there was any family history. The patient is vaccinated at a medical office (reported as). There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer Suspect. There was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer Suspect. Concomitant medication included levothyroxine taken for thyroid disorder (reported as thyroid) at 75mg; take once daily by mouth from an unspecified start date (reported as taking for 10 years) and ongoing. It was reported that the patient had the first vaccine 31Jan2021 at 14:30PM in the left arm. She was scheduled for the second dose 21Feb2021 but she had a heart attack and a pacemaker put in and had to cancel the appointment. She is trying to reschedule the second dose. It was mentioned she doesn't know who to call. Adds she called the number and was transferred here. Advised caller this is Pfizer DSU and we document our patient's experience with our products. Caller agreed to report. Mentions her daughter is a teacher and set up the first dose for the caller because the caller is her mother-in-law; so the caller plans to contact her daughter about getting the second dose. The patient stated that she did have a very bad reaction to the vaccine, she noticed after an hour after the shot on 31Jan2021, it was very sore at the injection site for about 10 minutes and then she got the same thing the next day. The pain came and went for 5 to 10 minutes at a time. They don't know if she was getting a heart attack or if it was the vaccine. The pain at the injection site went away when she went to the emergency room on 15Feb2021 and the put oxygen on her. She was admitted 15Feb2021 for a heart attack and then had a pacemaker put in. She was discharged 25Feb2021. Adds she is slowly recovering but the site where they put in the pacemaker is still sore on Feb2021. The outcome of the event heart attack was recovered with sequelae on 15Feb2021, for the event sore at the injection site was recovered on 15Feb2021 and for the event sore where the pacemaker was put in was not recovered. The patient did required a visit to emergency room for the event heart attack. The patient was hospitalized, for 10 days (from 15Feb2021 to 25Feb2021) for heart attack.

Afib; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 22Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer, the patient. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm on 30Jan2021 at 11:30 (Batch/Lot number: EL9265 and Expiration date: Jan2021) (at the age of 87-years-old) and dose 2 intramuscular, administered in Arm on 27Feb2021 at 13:30 (Batch/Lot number: EN6205 and Expiration date: 27Feb2021); both as single dose for covid-19 immunization. Medical history included none. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced Afib (Atrial fibrillation). Lab tests was none. The outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

patient had acute stroke 4/10/2021 requiring hospitalization. suspected related to paroxsymal afib etiology. Family requesting this be reported to VAERS as possible vaccine reaction.

3hrs after the patient's vaccination, she fell to the floor and was unable to get up, noted to have R sided facial droop, inability to speak, R sided weakness. Found to have a large stroke with left sided M2 MCA clot noted on CT angiogram.

My mother received doses of the Pfizer vaccine. She received the first shot on Friday March 5, 2021 at 12:15 PM and the second vaccine on Friday March 26, 2021 at 11:45 AM. Both vaccines were administered at the pharmacy. Early Tuesday Morning she was incoherent and suffered a stroke. She was taken to the hospital and spent the entire week at the hospital. Her primary doctor, was out of town and Dr was the covering doctor. While in the hospital she was under the care of another Dr

Early on Sunday morning, April 4th, patient woke up with swollen right hand with immense pain. On Monday, April 5th an ultrasound confirmed a blood clot in her right forearm.

STARTING HAVE SEVERE PAIN IN LOWER NECK UP INTO LEFT SIDE OF HEAD SEVERAL DAYS AFTER VACCINE. ER ON 3/15/21 SHOWED ARTHRITIS IN C-3. SENT TO DR FOR FOLLOW UP. 3/17/21 PUT ON ORAL PREDNISONE, PAIN SHOTS X4 IN AREA. 3/19/21 RETURN TO ER, INCREASED PAIN AGAIN, LOSE OF SIGHT IN LEFT EYE, CT SHOWED POSSIBLE VERTEBRAL ARTERIAL OCCLUSION WITH POSSIBLE DISECTION. ADMITTED. ALSO SAW MICRO VASCULAR CHANGES AND ATROPHY. NEURO CONSULT FOR THROMBECTOMY VS MEDICATION MANAGEMENT. PER FAMILY, PAIN MEDS, NO FURTHER MRI OF BRAIN, COMFORT CARES. PT DIED 3/22/21.

She had a TIA 19 days later. After recovering from that, she got the second shot and had another TIA 18 days after the second dose!

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.

PFIZER-BIONTECH COVID-19 VACCINE EUA. PATIENT VACCINATED WITH SECOND DOSE ON 2/8/21. PATIENT REPORTEDLY DISCHARGED TO HOSPITAL WITH PNEUMONIA ON 2/16/21. NURSING FACILITY WAS ADVISED THE PATIENT LATER PASSED AWAY AND WOULD NOT BE RETURNING.

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.

a touch of Pneumonia; still trying to get the second shot, and it's been 8 weeks and 3 days; still trying to get the second shot, and it's been 8 weeks and 3 days; This is a spontaneous report from a non-contactable consumer (patient's daughter) via Medical Information team. An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 02Mar2021 at the age of 87 years old (Batch/Lot number was not reported) as the 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had a touch of pneumonia, used inhalers, and cleared up. The patient was hospitalized for the event "a touch of pneumonia" on an unspecified date. The reporter stated that they were still trying to get the second shot, and it's been 8 weeks and 3 days. The reporter was asking if there would be worse side effects after getting 3 doses, if they did get the second dose as a first dose. The reporter was referred to their doctor or health care provider for further guidance, since they were the most familiar with their medical condition. The patient recovered from the event "a touch of pneumonia" on an unspecified date in 2021. The reporter stated that the pneumonia did not have anything to do with the shot she got, but it was after the first dose of the Pfizer vaccine. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of pneumonia. The reported event likely represent intercurrent medical condition. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

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.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient with generalized weakness since immunization. Two days after vaccination became dysarthric. Three days after vaccination became minimally responsive and brought to emergency department (ED) by ambulance. On arrival patient had right lower extremity weakness, right upper extremity mild drift, and severe dysarthria. Patient underwent thrombectomy and did not have residual neurologic deficits. Initiated on antiplatelet agent, anticoagulation, and cholesterol-lowering agent. Patient also experienced NSTEMI and newly diagnosed with heart failure and initiated medications for management. Patient discharged medically stable. Three days later patient admitted for atrial fibrillation with rapid ventricular response and worsening ischemia: initiated antiarrhythmic medications and patient improved and discharged medically stable.

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

Found deceased collapsed over edge of overflowing bath tub with head and upper torso submerged. Autopsy revealed signs of drowning and severe heart disease (hypertensive and coronary heart disease and cardiac amyloidosis). There was no evidence of anaphylaxis or myocarditis. Cause of death = Drowning Contributory causes = Hypertensive and coronary heart disease; Cardiac amyloidosis

Pt.'s daughter reports 03/29/2021 pt. started experiencing symptoms of dizziness, nauseous, dry mouth, fatigue, severe headaches, and confusion. On and off symptoms daily until 05/10/2021 severe weakness ER (by ambulance) confirmed Stroke. Bed-riddened currently and still severe confusion.

On Tuesday, March 9th, a friend of mine went to my mother's home to take her to a scheduled dentist appointment. Upon arrival, she observed that my mother was disoriented and her vision was impaired. Specifically, her right pupil was completely off to the right side, her eye was irritated and slightly swollen. Per recommendation from the primary care office, my mother was taken to the emergency room. She remained hospitalized for two weeks during which time, several labs and x-rays were performed; several ideas surfaced regarding root cause including Miller Fisher Syndrome, mini-stroke, etc. but no final diagnosis was identified.

She wasn't sick. She just said that she was tired and needed to go home to get some rest and she died that afternoon.

blood on her brain/clot on her brain; clot on brain and patient was in the hospital for 6 days; brain stroke; high blood pressure 220; headache on and off since she got the vaccine; was very sleepy; used to get cold; Paralyzed; can not talk; can not walk; she is bed ridden right now; her throat is not working good; This is a spontaneous report from a contactable Consumer (patient daughter). A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection. Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in arm on 27Mar2021 as dose 1, single for COVID-19 immunization (between 14:00-15:00) Medical history included the patient had ongoing high blood pressure when the patient was young but and was not taking high blood pressure medicines as did not need it and she had borderline pre diabetic and was supposed to take medication for pre diabetes but the patient was with the caller and her kids and always only takes Vitamin D and diet intake and controlled it like that. The patient had not taken medication for years. History of all previous immunization with the Pfizer vaccine considered as suspect reported as 1st dose. No additional vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. No adverse event reported prior to vaccination. The patient was hiding because she did not want the vaccine. The patient never went to the doctor, because the patient was very healthy before vaccination. The patient hates vaccines and did not want it and that is why such a hard time that day. Time of onset of adverse events they went to the hospital and realized The patient was like that at 10:30. The patient got the vaccine 27Mar2021, (Saturday) and the headache started (Monday)on 29Mar2021, that the headaches were always in the morning, The patient would wake up and they were on and off in the mornings. The patient was very sleepy and thinks that was because of the headaches, they were very strong headaches. When they used to give babies vaccines they would get sleepy and she thinks its the vaccine and to just lay down here and would put her on her bed and she laid down with the headache and she gave Motrin and she would fall asleep. The patient used to get cold and would put blankets on her and she would fall sleep and it was on and off and states for 2 weeks it was probably 3-4 times a week. The patient had blood on brain and was hospitalized with high blood pressure 220 on Mar2021 when she was at the hospital and had the brain stroke 10Apr2021, clot on brain and the patient was in the hospital for 6 days. The patient cannot talk and walk, bed ridden right now and paralyzed on an unspecified date in Mar2021. The patient was bed ridden right now on an unspecified date in Mar2021 and her throat was not working good on Mar2021. She had headache on and off since got the vaccine on 29Mar2021 and was very sleepy on an unspecified date in Mar2021, used to get cold on an unspecified date in Mar2021. Caller did not recall the day she was released. It was reported that, now she was ok. They did physical therapy for 2 months to see if they can bring back but were not able to. The patient was kinda like stuck and the only thing. The patient improved they removed the IG tube. The patient was eating through and she was now eating thick foods as throat was not working good, like baby food blended. States the card has the clinic site and when to go for the 2nd dose but she did not go back because of this. It was reported that, when they went to the hospital that day with the clot on brain the doctor asked if she had any bad news or any type or received anything thinks because of the high blood pressure was why he was asking. The patient was fine and watching TV and had a headache on and off since got the vaccine. The reporter stated that she told the doctor she got the vaccine 2 weeks ago and the doctor said it was the vaccine. The reporter stated that the patient did not know what testing was done, they were trying to give something for the clots from brain without getting surgery but it was not working and pressure was so high and the clots would not move, it was not able to do it. The patient did not know what they did but the other option was to remove the clots. The patient visited to emergency room and did not went to Physician Office. The patient was planning to take her to the doctor because of the headaches but was so busy and was having a project at work. The patient underwent lab tests and procedures which included blood pressure measurement: 220 mmhg on Mar2021 when she was at the hospital. The outcome of the event oropharyngeal discomfort was not resolved and outcome of the other events were unknown. Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.

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.

4/22/2021 Tested positive for COVID-19 discovered during Universal Testing on specific Unit. Resident was asymptomatic. COVID-19 screening completed every 4 hours. 4/26/2021 Received therapeutic treatment Etesev-Bam 1400mg IV. 5/2/2021 Developed increased temperature and foul smelling urine. Rocephin 1 Gram given daily on 5/2/2021 and 5/3/2021. 5/4/2021 declining clinical presentation with fatigue. Morphine and ativan started for End Of Line/Comfort Care. 5/10/2021 Continued declining vital signs, fatigue, pain. Deceased on 5/10/2021

Initial pain in back of head and extreme headache. Some vomiting. At emergency, went into coma and was intubated. Hole drilled in skull to relieve pressure. MRI taken. Lot of bleeding in brain - anuerism lead to death approximately 14 hours after initial symptoms.

passed away; This is a spontaneous report from non-contactable consumers received via a Pfizer-sponsored program An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via an unspecified route of administration on 30Dec2020 at a single dose (1 dose) in the left arm (LA) (administered by: senior living) as Covid vaccine. Medical history included patient was 14 plus days post COVID and unresponsive. The patient had no listed allergies. Concomitant medications were not reported. The patient passed away with an hour and half of receiving vaccine on 30Dec2020. Per nursing staff, they did not expect the patient to make it many more days. She was unresponsive in the room when shot was given. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: passed away

Reportedly, this employee's mother died the night of the vaccine. The details are not known at this time.

Patient tested positive for COVID-19 on 1/8/21. She demonstrated a decline in appetite and the ability to feed herself d/t this illness, but no respiratory or other symptoms. She received COVID-19 vaccine #2 on 1/26/21. She demonstrated an SDTI wound to the Lt. heel on 1/27/21. On 1/31/21 she was noted to have a significant weight loss. She was admitted to services on 2/1/21 with comfort care orders. On 2/2/21 she was observed to be without vital signs. Orders were for DNR, and CPR was not initiated in accordance with that order. She was pronounced dead at 0112 on 2/1/21.

Resident passed away 2 days after receiving the vaccine. oxygen level has decreased shortly 1 day after receiving the vaccine.

7 days after receiving the vaccine, patient suffered excessive diarrhea and slight coughing. 9 days after vaccine, patient was tested for Covid 19, and received positive results. Patient was transported to hospital via ambulance but hospital returned her to the nursing home since chest was clear, no respiratory issues, and no fever. 10 days after receiving the vaccine, patient was turned over to hospice care but still in the nursing home. Hospice was called in to provide better physician advice and access 24/7. 14 days after receiving vaccine, patient began experiencing excruciating body aches, coughing, low oxygen levels, and no appetite. 18 days after vaccine, patient died.

The patient suffered embolic strokes and was admitted to the hospital the day after she received her first COVID-19 vaccination. She has a history of strokes, with atrial fibrillation, but was faithfully taking her Eliquis at the time she suffered these recurrent strokes.

Fall; fatigued; arm pain; AML; Sepsis secondary to AML; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 19Jan2021 17:30 in right arm at single dose for covid-19 immunization. Medical history included hypertension, hyperlipidemia, OA (osteoarthritis), cognitive impairment. No other vaccine in four weeks was administrated. Concomitant medication in two weeks included atorvastatin, aspirin, calcium, gabapentin, losartan and memantine hydrochloride (NAMENDA). The patient previously took lisinopril and tetracycline and both experienced allergies. The patient had no covid prior vaccination. The patient initially had no symptoms but arm pain in Jan2021, no bleeding or bruising from injection. On 31Jan2021 19:00, patient felt fatigued. Patient suffered fall on 01Feb2021. She was admitted to hospital. All cell lines were down in Feb2021. She was diagnosed with AML (acute myeloid leukemia) in 2021. She expired 07Feb2021. Events resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event) and patient died. The patient received the treatment of blood and platelet transfusions, bone marrow biopsy, cytogenetic testing, antibiotics, intubation for events. The patient died on 07Feb2021 due to sepsis secondary to AML. An autopsy was not performed. Outcome of events were fatal.; Reported Cause(s) of Death: arm pain; fatigued; fall; Sepsis secondary to AML; Sepsis secondary to AML

Drop in hemoglobin level; Idiopathic thrombocytopenic purpura; This is a spontaneous report from a contactable consumer. An 88-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 04Feb2021, at single dose, for COVID-19 immunisation. Medical history included diabetes mellitus, hypertension and other unspecified conditions. Patient did not have known allergies and did not have COVID-19 prior to vaccination. Concomitant included unspecified multiple medications. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient experienced drop in hemoglobin level resulting in idiopathic thrombocytopenic purpura (ITP) on 04Feb2021 with outcome of not recovered. The event resulted in physician office visit and emergency room visit. Patient had no history of ITP prior to vaccination. The event was considered serious as caused patient's hospitalization and as life threatening. The patient underwent lab tests and procedures which included hemoglobin: drop on 04Feb2021. Therapeutic measures were taken as a result of the event and included treatment with multiple unspecified drugs. It was unknown if she was tested for COVID-19 after vaccination. The information on the lot/batch number has been requested.

Pfizer-BioNTech COVID- 19 Vaccine EUA Patient received COVID-19 Vaccine dose #2 on February 24, 2021. On February 25th at 10:36 AM,Patient's son called physician to report some side effects to second dose of Covid vaccine. She had diarrhea when she came home yesterday. Son has been up all night with her as patient has had a "hacking cough,feels terrible, and now has had diarrhea x2". Patient has taken Advil and will be taking tylenol periodically through out the day for her side effects. Patients son notified physician at 09:55 AM on February 26 that the patient has expired.

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

WE RECEIVED A TELEPHONE CALL AT 4:45 PM ON 1/27/21 THAT WAS NON RESPONSIVE AND A FOLLOWING CALL AT 5:00 PM THAT SHE HAD PASSED.

patient was vaccinated with second covid vaccine on 2/12/21. Patient was admitted to the hospital on 03/04/2021 with fatigue and diagnosed with COVID 19 (positive lab test on 2/26/21 and 3/4/21). Case expired on 3/8/21.

Syncopal episode, eyes rolled back, extremely diaphoretic and not completely out. CODE EMERGENCY CALLED. 911 also called due to hx of lung ca with mets.

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.

PFIZER-BIONTECH COVID-19 VACCINE EUA. PATIENT VACCINATED WITH SECOND DOSE ON 2/8/21. PATIENT REPORTEDLY DIED ON 2/15/21 AT 5:02AM. RECORD OF DEATH FROM NURSING FACILITY STATES CHF AS PRINCIPLE CAUSE OF DEATH AND CONTRIBUTORY CAUSES: FRACTURED HIP, A-FIB, STAGE 3 CKD.

Feb 17 - second pfizer shot. Shortly after second dose, was instructed to stop warfarin (for h/o VTE, pt with IVC filter) March 3rd - ultrasound of legs both clear ~April 27th - c/o leg pain May 6 - admitted to hospital with DVT, PE

ED to Hosp-Admission Discharged 3/28/2021 - 3/30/2021 (2 days) Last attending ? Treatment team Weakness Principal problem Discharge Summary DO (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Date: 3/30/2021 Admission Date: 3/28/2021 Length of Stay: 2 Days Discharge Date: 3/30/2021 Admission Diagnosis Hospital Problems POA * (Principal) Weakness Yes Hypothyroidism Yes Pure hypercholesterolemia Yes Benign essential hypertension Yes Atrial fibrillation Yes Acute cystitis without hematuria Yes Generalized weakness Yes COVID-19 virus infection Yes Chronic respiratory failure with hypoxia Yes Home Under Care of a company unnamed CODE STATUS: Full Code Active Issues Requiring Follow-up Finish course of antibiotics. Participating remote monitoring. Test Results Pending at Discharge Pending Labs Order Current Status Blood culture Preliminary result Blood culture Preliminary result Hospital Course HPI: Patient is a 89 y.o. female with PMH listed who presents from home with her daughter complaining of about a week of increased weakness/fatigue and cough. The fatigue is their primary concern, as this is so profound she will fall asleep on the toilet or even in the middle of getting dressed. Appetite is decreased, but she denies N/V/D. She feels "chilled", but no known fevers, no rigors/sweats. Cough is occasionally productive of sputum, mostly clear but sometimes with small "chunks"; no hemoptysis. No LE edema. No HA or changes in taste/smell. No known sick contacts, but patient has exposure to multiple daughters who help care for her, and she has been attending church recently. Urine is dark/strong, but she denies dysuria. Pt has received both doses of COVID-19 vaccine, second dose on 3/17/21. Hospital Course: Patient was admitted to medical floor for COVID-19 infection and urinary tract infection. Patient had a very mild course of illness. Decadron was started but patient did not require any remdesivir. Patient has remained at her seen home oxygen requirement. Patient was seen by PT and OT services for generalized weakness. Blood cultures have been negative. Patient is medically stable for discharge home today. She will need another 2 days of antibiotics treatment for urinary tract infection. Since her respiratory status has been very stable, we have chosen to discontinue the use of Decadron upon discharge to avoid any changes in mental status induced by steroids in an elderly patient. Home health services and remote monitoring kit have been ordered at the time of discharge. I have called patient's daughter to provide update that patient is coming home today and answered her questions

Patient developed an episode of depressed BP and elevated heart rate the morning of March 10 2021. Felt light-headed and sought medical help at PCP office. referred to ER, where diagnosis of Afib was given, and appropriate medication was administered. Patient had no prior history of Afib, or any other arrhythmias. Followup care of cardioversion.

Patient got her vaccine then the next day developed weakness and knee pain. Later the daughter admitted that she had had increased weaknesss and confusion for a few weeks. She was seen in her PCP's office and diagnosed with a UTI and gout. The x-ray of her knee later showed a fracture of her proximal tibia. A few days later she was brought to the emergency department with a wide complex tachycardia and acute coronary syndrome. She had an 11 day stay complicated with congestive heart failure, hypoxia, aspiration pneumonia and metabolic encpehalopathy. Her daughter thinks that this was brought on by the vaccine, and asked us to fill out a vaers.

Pt was admitted to hospital from ED with A-fib on 4/5/21 after receiving the 2nd dose of vaccine on 3/30/21

2 months after last dose, a routine bloodwork revealed high kidney numbers. Voice became hoarse and difficulty in swallowing ease was noted. Repeat blood work confirmed kidney numbers still high after hydration, IV fluids given at home. Fatigue increased and I took my mother to the ER. She was admitted and she spent 3 weeks in the hospital, 1 week in ICU. She was eventually diagnosed with the autoimmune disease ANCA Vasculitis. Biopsy confirmed. No previous kidney disease or abnormal blood work. She was treated with high dose steroids and chemotherapy. There was no positive response to treatment. Condition worsened and she was moved to Hospice care. My mother died on 05/16/2021

No affects from first shot. Second shot seemed ok until midnight when my wife fainted. She is on a blood thinner and it made the levels change and set off her A-fib . The next 3 days she had body pain. Her leg strength has weakened. It has been over a month and she is not back to the levels of health she had before the second shot. I also notice she rambles in conversation.

Dose 1 on 2/1/2021, dose 2 on 2/21/2021. Symptoms of cough, malaise/fatigue and weakness on 06/15/2021. Diabetes Type 2- not well controlled ON LONG TERM MAINTENACE TREATMENT FOR MELANOMA. Pneumonia possibly due to COVID-19. Patient had received 2 doses of Pfizer COVID vaccine in February of 2021. COVID positive test on 6/23 Exposed to daughter (vaccinated, symptom onset on 6/21/2021).

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

I63.9 - Cryptogenic stroke (CMS/HCC) I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) N17.9 - Acute kidney failure, unspecified

There were no adverse reactions. Resident Died, she had a history of issues with her health prior to the vaccine.

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.

The nursing home resident received the vaccine at 11:00 am. At 11:45 am she had an episode of non-bloody, non-bilious vomiting. At 12:00 pm she had an episode of loose stool. At 12:15 pm she was noted with generalized tonic-clonic seizure-like activity. Oxygen was applied via non-rebreather mask and resident was transferred to the Hospital Emergency Department for further evaluation. At the time of this report, she is stable in the ED and awaiting imaging studies. (head CT)

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.

Resident per her usual health when dietary staff were into apartment at 0730 with her breakfast. Resident conversing, appropriate, with no focal deficits with ADL. Resident baseline with mild confusion, generalized weakness, using a 4 wheeled walker when ambulating. Med care manager into room at 0830 with am medications. Resident was lying partially on her bed, non responsive. EMS was called immediately and resident was transported to Hospital ER. Wellness nurse was notified later that resident was admitted for rule out CVA.

on 2/1/2021 Resident Reported Back pain given Tylenol Medication orally For Relief. APPRoximately 30 Min Later. complaint of & Noted Diarrhea, Shivering, and vomiting SenT To ER 2/1 And Admitted Diagnosis: Sepsis

Patient was found with no pulse no heart rate by a staff member around 11 pm. Earlier that day seen by myself for fatigue, sorethroat, nausea.

presumed cardiac failure; This is a spontaneous report from a contactable nurse. An 89-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular at arm left on 10Feb2021 (at the age of 89 years) at single dose for COVID-19 immunization. The patient medical history included congestive heart failure, coronary artery disease, hypertension, hyperlipidemia, osteoarthritis, presence of prosthetic heart valve and allergies, all from an unknown date and unknown if ongoing. The patient's concomitant medication included amlodipine besilate/benazepril hydrochloride, amlodipine, acetylsalicylic acid (ASPIRIN E.C.), atorvastatin, benazepril, carvedilol, ubidecarenone (COQ10), furosemide, acetaminophen and potassium chloride. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), intramuscular at arm left on 20Jan2021 at single dose for COVID-19 immunization. The patient experienced presumed cardiac failure on 12Feb2021 at 03:30 with fatal outcome. The patient died on 12Feb2021. An autopsy was not performed.; Sender's Comments: Based on the current available information, the event Cardiac failure is most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. The patient medical history of congestive heart failure, coronary artery disease, hypertension, and hyperlipidemia provide plausible explanations for 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: presumed cardiac failure

THE RESIDENT WAS ROUTINELY TESTED FOR COVID ON 1/29/21 AND POSITIVE RESULTS RETURNED ON 1/30/21; WAS ASYMPTOMATIC AT FIRST, BUT DEVELOPED SYMPTOMS ON 1/31/21 THAT PROGRESSED AND THE RESIDENT DIED ON 2/7/21

Resident fell out of her chair and was transferred to the ER with a diagnosis of a Mio cardial infarction and passed away in the ER.

PFIZER-BIONTECH COVID-19 VACCINE EUA. PATIENT SENT TO HOSPITAL FROM NURSING HOME ON 3/15/21 WITH DIARRHEA, VOMITING AND AMS. ADMITTED AND REMAINS HOSPITALIZED ON 3/17. PATIENT TESTED POSITIVE FOR COVID-19 ON 3/15 AND HAS RECEIVED BOTH DOSES OF VACCINE MORE THAN 2 WEEKS AGO. HOSPITALIZATION REPORTED TO BE RELATED TO PATIENT SEPTIC WITH GI INFECTION. POSITIVE COVID INFECTION IS INCIDENTAL. PATIENT ON ROOM AIR. NO FINDINGS ON CHEST X-RAY.

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.

low b/p coupled dizziness; Hx of Cerebral infarct; numbness to limbs Age 89 Note: Resident came back from the emergency department at medical center at 1:45.The resident is alert and oriented. The resident has been diagnosed, with deconditions, paresthesia, and gait instability. CT of the head was reassuring. No significant labs or EKG abnormalities noted. No new medications order received.

resident unresponsive verbally and favoring L side with R side flaccid unable to take AM med. The writer obtained BS 90. The resident has R side face drop with drooling noted. The resident responded to painful stimuli only. Pupils dilated. Supervisor at bedside BS 102 rechecked. The family opted for comfort measures only. Age 68 On 2/15/2021 Z51.5: ENCOUNTER FOR PALLIATIVE CARE, Patient expired 2/23/2021

Acute syncope with two syncopal episodes, found to have bilateral subsegmental pulmonary emboli and oxygen requirement

89 yo female with PMH HTN and hepatitis B was COVID19+ on 2/2/2021. On 2/20/21, patient received a first dose of Pfizer BioNTech COVID19 vaccine 30 mcg/0.3 mL IM x 1 (lot# EL9261; left arm). Was seen in ED c/o back pain and bruising. On admission Platelets=3k and Hgb=8.6. Patient treated for Evans syndrome: ITP and hemolytic anemia. Patient received 1 units platelets, IVIG 55gm IV daily x 2 days, Rituximab 560mg IV weekly x 4 (1 dose given during this admission), dexamethasone 40mg IV x 4 days followed by a prednisone taper. Per hematology, "spontaneous development of warm atuimmune hemolytic anemia as well as ITP is of unclear etiology. No malignancy has been isolated. There are some rare case reorts of ITP from COVID vaccination. Ultimately, we cannot prove whether this is due to the COVID vaccine." Patient was counseled to not undergo the second dose of COVID vaccine.

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.

She had her second dose of the covid vaccine approx 8 days ago, the day after she was very tired and slept all day. Then yesterday when she awoke she had a sense of discomfort in the left eye, and a friend who helps them at home noticed that her left eye was slightly bloodshot. Yesterday she went to see her eye doctor who dx her with an incidental small burst blood vessel but did not advise stopping eliquis and said it should resolve within weeks. She has no loss of vision. However, in the evening when at home she said she had difficulty forming words - husband did not particularly notice a problem - she ignored it basically and went to sleep . Then this morning went to the hairdresser, noticed the word finding/ speech 'garbled' slightly problem again and walked into her pcp office - she was eval'd there at approx 1140 am and sent to ER by ambulance. Code green not called given the initial deficit was last night, CT head suggested possible subacute infract. She had no chest pain or pressure, trop noted as slightly elevated at 129 , Platlets 84 Diagnosed with Bilateral punctate infarcts throughout the brain, in cerebellum, occiput, left temporal and parietal lobes

The son came on 05/06 to receive the 2nd dose of Pfizer vaccine and informed us that his mother passed away on 04/18 after 3 days of post vaccination. A home hospice patient with Stage 5 Chronic kidney disease and Stage 4 COPD (Oxygen dependent) came in on 04/15 around 4:30 pm to receive a first dose of Pfizer. After 15 mandatory waiting in the pharmacy, she went home. Around 5:00 pm, patient told her son that she is feeling nauseated. Hospice nurse was contacted. On 4/16, patient experienced hallucination. She told her son that her fingers were disappeared. Hospice nurse was contacted. Please note that vaccine adverse event is not clearly related to vaccine, since patient was on hospice, stage 5 CKD and stage 4 COPD.

autoimmune (Coombs positive) hemolytic anemia; idiopathic thrombocytopenia purpura; This is a spontaneous report from a contactable physician. An 89-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient was not pregnant. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.The patient experienced autoimmune (Coombs positive) hemolytic anemia as well as idiopathic thrombocytopenia purpura in Mar2021 with outcome of recovered in 2021. The patient was hospitalized for both events from 2021 to an unknown date. The patient received Prednisone, IVIG as treatment. The events also resulted in Emergency room/department or urgent care and considered as Life threatening illness (immediate risk of death from the event). Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported autoimmune (Coombs positive) hemolytic anemia as well as idiopathic thrombocytopenia purpura and the use of BNT162B2 cannot be excluded. The case will be assessed further upon receipt of additional 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 RAs, Ethics Committees, and investigators, as appropriate.

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.