Pfizer

Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccination patient became tired and experienced a headache. The next day at 2:15pm the patient reported a temperature of 99.0 degrees Fahrenheit, not being as tired, but starting at 9:30 am that morning experiencing "tongue being tied" and having difficulty communicating described as "know what they want to say but it... doesn't come out" that lasted three hours. The patient denied problems walking or being confused. The patient was immediately referred to the emergency department for evaluation. Upon arrival to the emergency department patient had clear speech speaking in complete sentences and ambulating independently with a steady gait. Physical and neurological exams both normal: no aphasia and no focal neurological deficits, normal strength and sensation throughout. Initial vital signs within normal ranges except blood pressure 149/88 mmHg. Patient remained asymptomatic and stable throughout emergency department stay. Repeat vital signs were within normal ranges and patient was discharged to home with a diagnosis of transient ischemic attack. On follow-up visit with primary care physician four days after vaccination patient reports feeling much better and no new symptoms reported.

Episode of atrial fibrillation documented by my husband, a physician. He could not find a pulse after I had 2 near syncopal episodes. He listened to my chest and heard the abnormal rhythm . By the time I arrived at the ER, I had converted into normal sinus rhythm. We are both physicians. I am currently being evaluated by my PCP.

First vaccine small bruise at her left knee and extreme pain in her neck, shoulder and left arm and missed work. Second vaccine she has 4 bruises and clots on her inner leg from ankle to thigh. So painful she can't sleep and she is having a hard time walking. Her left shoulder is limited due to extreme pain. She sought care from her physician and he is sending her for scans that the facility is requiring a deposit.

Episode of atrial fibrillation; This is a spontaneous report from a contactable physician (patient). A 60-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176), via an unspecified route of administration at Left arm on 13Jan2021 09:15 at SINGLE DOSE for COVID-19 immunization. The patient was not pregnant. Medical history included scoliosis and depression. Concomitant medications in two weeks included duloxetine hydrochloride (CYMBALTA), estradiol/norethisterone acetate (COMBIPATCH). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EH9899) received on 20Dec2020 05:00 PM at left arm for COVID-19 immunization. The patient previously took codeine and experienced drug allergies. The patient experienced episode of atrial fibrillation on 17Jan2021 at 05:45 AM. No treatment received, no COVID prior vaccination. The outcome of the event was unknown.; Sender's Comments: Based on a compatible temporal relationship, causality between event episode of atrial fibrillation and BNT162B2 vaccine 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.

admitted to hospital with platelet count of 8,000; petechiae; This is a spontaneous report from a contactable physician. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) via Intramuscular on 18Jan2021 into left arm at a single dose for covid-19 immunization. Medical history included hypothyroidism and neomycin allergies. The patient did not get covid prior vaccination. Concomitant medications included calcium, levothyroxine sodium (SYNTHROID), trazodone, tocopherol (VIT E) and no other vaccine in four weeks. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9261) via Intramuscular on 28Dec2020 into left arm at a single dose for covid-19 immunization. 24 hours after injection she developed petechiae and was admitted to hospital with platelet count of 8,000 on 20Jan2021 22:00, the patient has ITP with baseline platelet count of 60,000. All events lead to hospitalization for 5 days (PENDING CLARIFICATION) and received IgG and oral Dexamethas as treatment. On 20Jan2021, the patient did Sars Co V 2 RNA test via Nasal Swab and result negative. The outcome of the events was recovering.; Sender's Comments: Based on a close chronological association, a causal relationship between events petechiae and thrombocytopenia and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Thrombocytopenia. Bone marrow biopsy on 2/1/2021 showed severe peripheral pancytopenia and acellular marrow space, consistent with aplastic anemia. Patient has received dexamethasone, platelets, and PRBC. Unknown outcome patient has been discharged from the hospital.

presented 1/27 to ED with rigors, dyspnea chest pain and R ear pain post COVID vaccine, thought to initially be systemic SEs from the vaccine but found to have re-collapse of the BI on chest CT with probable post obstructive pneumonia. still admitted as of 2/23/2021

Heart attack; Myocarditis; Chills; didn't check her temperature but is sure she had one/She didn't check her temperature but she is sure she had a fever; was soaking wet when she woke up like her fever had broken and then she was fine/She woke up and was very sweaty; achy right side; Headache; This is a spontaneous report from a contactable consumer who reported for herself, a 60-year-old female patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration in the right arm, on 06Jan2021 at 18:00 at the age of 60 years, at a single dose for Covid Prevention/COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously received the first dose of Covid-19 vaccine (Manufacturer: Pfizer, with Lot Number: EK5730) in the right arm, on 18Dec2020 at the age of 60 years for COVID-19 immunization. The patient reported that 13 days after the last dose of the vaccine, on 19Jan2021, she had a heart attack. She has no heart issues whatsoever. She had diagnostic testing such as a cardiac catherization, echocardiogram, both on 19Jan2021; and a heart MRI with contrast on 20Jan2021. The test results indicated that she had myocarditis caused by a virus. The cardiac catherization and echocardiogram also revealed heart attack because of myocarditis. She did not have any other issues with her heart. The patient asked if they would they let her know if anything comes up as far as information. The patient has recovered with lasting effects. She would be on medication for the next 3 years supposedly. The heart attack was caused by myocarditis which was caused by a virus. There were no other issues with her heart, arteries or anything. These events required a visit to the emergency room. She first went to a hospital in the city and was transferred via ambulance to another hospital in another city on the same day. Patient was hospitalized for the heart attack and myocarditis from 19Jan2021 to 22Jan2021. She had a lot of other symptoms the next day after receiving the vaccine on 07Jan2021. She also experienced chills. She didn't take her temperature but is sure she had one. She was achy on her whole right side and she had a headache. She started having chills at 1:30 PM (13:30) while at an eye doctors appointment. She laid down and was soaking wet when she woke up like her fever had broken and then she was fine. She didn't check her temperature but she is sure she had a fever. She woke up and was very sweaty. The outcome of the events heart attack and myocarditis was recovered with sequelae on Jan2021. The outcome of the remaining events was recovered on 07Jan2021.

stroke occurred five days after receiving vaccine. I was hospitalized overnight in General Hospital. Have had two MRI's.

Sore nipples and armpits for several days then today light vaginal bleeding I am in or done with menopause and have not had a period for several years

This is a 60 year old female was brought into emergency department as cardiac arrest. Patient was seen at care now urgent care with the complain of epigastric pain associated with nausea vomiting and intermittent diarrhea. Patient received her initial COVID vaccine 2 days ago. History is obtained from urgent care chart. As per notes patient started nausea vomiting 6 hours post COVID vaccine administration. Patient was seen in urgent care for epigastric pain and nausea vomiting. Patient was found unresponsive at 0902 by tech. No carotid pulses palpated. CPR was started. Patient was brought into the emergency department with Lucas on. Patient was given 5 epinephrine prior to arrival. CPR was in progress. Patient was asystole. Resuscitation was continued in the ED. Patient was intubated in the ED by physician assistant 5 epinephrine 2 bicarb and 1 calcium chloride was given in the ED. Cardiac Ultrasound didn't show any cardiac activity. Asystole on the monitor. No corneal reflex people are fixed and dilated. Patient was pronounced at 1007 am

Began to feel bad one week after receiving injection and made appt with provider, xray showed infiltrate, pnuemonia, in right lower lobe, antibiotics prescribed and taken increased shortness of breath at time of visit.

After developing blood blisters in my mouth and a rash on my feet & legs, I phone the Advice Nurse and had a phone consult with Dr. I had a blood test the following morning and recieved a call the next morning at 5:40 a.m. directing me to my local Emergency Department as my platelets measured only 16. I checked in 3/30/21 and following a new blood test showing my platelet count was down to 2, a Gastroenterologist diagnosed me with severe ITP. I then was treated with prednisoone, plasma transfusion and IGG (i think) infusion. An additional blood test showed my platelet count rose to 50. A CT scan showed no abnormalities.

12-48 hrs post vaccine: nausea, fever, headache, muscle aches, malaise; took tylenol; 48-96 hrs post: malaise; 5th-10th day post: coronary vasospasms, malaise, arrhythmia; took nitroglycerin patches, nitro bid paste; 11th day: met with rheumatologist, started medrol dose pack, improved spasms for a short time, 13th day: afib symptoms and Apple Watch reading noted by patient; 15th day spasms began again and increased symptoms of afib: saw doctor in office for EKG showing afib; met with cardiologist ordered increase in diltiazem and second medrol dose pack; first 48 hrs on second dose pack improved spasms, by 3rd day spasms significantly increased and constant afib w headache, dizziness, malaise. Visited ER, admitted. cardio version. Reduced dilitiazem, reduced ramipril, increased isosorbide. Continued symptoms with waxing and waning of spasms and atrial fibrillation . Although this is a pre-existing chronic condition, Afib without relief is not normal. Spasms without resolution not normal nor have I experienced an episode of this duration ever.

Pt reports onset on nausea and palpitations approximately 10 hours after receiving first dose of vaccine. Pt reports Emergency room visit, where she states she was diagnosed with atrial fibrillation. Pt reports she underwent 3 days of hospitalization, converting spontaneously without treatment to normal sinus rhythm.

Received first shot on 3/15/21. On 3/25/21, I developed a rash (hives) around 6:30-7pm. After dinner, around 7:30pm I noticed that my lips were swollen and the rash was spreading. Took one Benadryl and waited 1 hour. Condition worsened so left for ER around 8:45pm. Once there, I was diagnosed with an anaphylatic reaction. I was given Prednisone, Pepcid and Benadryl intervaneously. The Benadryl injection caused my throat to close for a few seconds. Things calmed down so we waited an hour to see if I was responding. There was not a lot of improvement so ER doctor decided to use Epinephrine (EP pen injection). After 2 hours of observation, I was set home to follow up with primary care physcian.

anaphylaxis with stridor and diffuse wheezes. No rash, GI symptoms. Received epinephrine, bronchodilators, IV steroids, histamine blockers, epinephrine drip. ICU admission

Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor; Anaphylaxis; chest hurt to breathe; Itching in my arms and chest in the evening.; rash; This is a spontaneous report from a contactable healthcare professional (patient). A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Left arm on 15Mar2021 at 17:00 (Batch/Lot Number: EP8534) as SINGLE DOSE for covid-19 immunisation. Medical history included Only occasional migraines. Never anything like this and known allergies: Some grasses. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included probiotics (PROBIOTICS) taken for an unspecified indication, start and stop date were not reported; betaine hydrochloride, bromelains, cellulase, pancreatin, papain (DIGESTIVE ENZYMES) taken for an unspecified indication, start and stop date were not reported. On 18Mar2021, at 8pm, the patient reported that "3 days after 2nd shot I started itching in my arms and chest in the evening. Went to bed and woke up at 4 am to pee. Afterwards I blacked out and work up on the bathroom floor. My rash was worse and spreading and chest hurt to breathe and I had bumps on head so we called # and nurse and my husband drove me to (Name). They gave me an IV and epinephrine shot and Pepcid and did CT scan of head and blood work. Diagnosed Anaphylaxis. They sent me home a couple hours later with prescription for Epi pens Zyrtec and Famotidine. Over the course of Friday my rash/hives got worse and spread over my body and my lips /mouth started to swell. I called the nurse who suggested I come back in and they checked by throat to ensure it wasn't closing up and gave me ibuprofen and Benadryl and sent me home. Rash/hives worse and spread all over body and face when I woke up Saturday morning (today). Plan to see specialist Sunday or Monday." The outcome of the events was not recovered. The patient was not tested for COVID-19 after vaccination.

'm post-menopausal, since March 2011 with no issues. 5-6 days after getting vaccination, I spotted very lightly, bleeding vaginally. It happened on and off, for two days then stopped. No cramping or other symptoms. When I read that this had happened to some patients, I thought I'd better report my occurence too. No treatment or doctor visit necessary. It was just a surprise .

Two weeks after 1st Pfizer shot I began to have very heavy breathing while on a daily walk that continued with any exertion. It continued for several days. I called PCP and was seen. Chest Xray & bloodwork was done. Was called to go to E.R. for CT scan of lungs. Pulmonary Embolisims were seen and a blood thinner was given. Heart monitored for previous Afib (ablation performed 5 yrs ago). CT scan w/dye was done of abdomen, Right leg ultrasound with compare L, MRI w/contrast done of abdomen/pelvis. No reason has been found for cause of several blood clots in both lungs - sub arteries. Am being followed up by Vascular Doctors in 2 weeks.

Pt developed symptoms of a pulmonary embolism (4/3/21) 10 days after 1st vaccine (3/24/21) Presented to hospital 4/12 with progressive symptoms. Diagnosed and started on blood thinners with tpa administration for severe right heart strain followed by discharge home.

Patient called me Wednesday April 14,2021 at 12:44 pm explaining that she was having a hard time breathing that day. Due to her chronic lung health, I didn?t think much of it. She passed away in the early hours of Thursday April 15,2021 in her sleep.

I fainted; blood clots; light headed; I lost all color and my skin was wet and clammy; I lost all color and my skin was wet and clammy; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199, via an unspecified route of administration, administered in right arm on 04Mar2021 15:00 as single dose for Covid-19 immunisation. Medical history included known allergies to Atovaquone/proguanil. Concomitant medications were not reported. On 04Mar2021, approximately 10 minutes post vaccine, the patient fainted in the waiting area. She was told by a witness that she fainted two times. EMTs administered an IV and did a simple EKG. The patient lost all color and her skin was wet and clammy. EMTs were concerned about her heart and transported her to the ER where she had a full EKG and lab work for D-Dimer to consider blood clots. The patient has remained lightheaded for weeks after the vaccine. The outcome of the events was recovered with sequelae.

Stroke - Cerebellar hemorrhage. Had to have brain surgery to relieve the pressure and a drain placed. She has a history of low blood pressure, never high. They did an angiogram that came back normal and an MRI as well. They have been unable to find a cause of the stroke at this time. She was in ICU for four days then Neuro PCU for about 4 days and now she is in inpatient rehab. She is currently learning to walk and has weakness on her whole left side. Vision issues. And motor control issues of the left arm. The stroke came on very sudden and she felt fine before her sudden ?worst migraine ever?. Luckily my brother was with her and took her to get help straight away before she became unconscious.

Pneumonia; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6200) via intramuscular, administered in Arm Right on 19Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient is not pregnant. No other vaccine received in four weeks. Patient experienced pneumonia after first injection on an unspecified date in 2021. Event resulted in Doctor office visit, Emergency room or urgent care, Hospitalization, Life threatening illness. Patient admitted to hospital for 5 days and received treatment. Unknown if patient had COVID prior vaccination. Unknown if COVID tested post vaccination. Outcome of the event was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event pneumonia 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. Linked Report(s) : US-PFIZER INC-2021423487 same patient/product, different dose and event

Blood Clot; This is a spontaneous report from a contactable nurse. A 60-year-old female patient (no pregnant) received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208), intramuscular at the age 60-year-old at arm right on 11Mar2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), intramuscular at the 60-year-old at right arm on 19Feb2021 for COVID-19 immunisation and experienced pneumonia. There was no other vaccine in four weeks. Facility type vaccine was reported as public health clinic/administration facility. The patient experienced blood clot on Mar2021 after 2nd. The patient was hospitalized for event for 5 days. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness. The patient received the treatment for event. The outcome of event was unknown.; Sender's Comments: Based on information available, a possible contribution role of the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of event clot blood cannot be completely excluded. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021422806 same patient/product, different dose and event

thought she was having a stroke; severe cramp in her left leg below the knee to her toes and it is extremely painful; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure high diagnosed about 7-8 years ago. The patient's concomitant medications were not reported. The patient got her first dose of the Pfizer Covid vaccine on 09Apr2021. On Saturday, 10Apr2021, she got this severe cramp in her left leg below the knee to her toes and it is extremely painful and thought she was having stroke. She stated that she was treating with a warm cloth and was going to go to the emergency room; rubbing down in case there is a blood clot. She wanted to know if this could be from the vaccine. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

DVT Right Leg; This is a spontaneous report from a contactable other healthcare professional (patient). A 60-year-old female patient received second dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm on 04Feb2021 08:30 (Lot Number: EL1283), at the age of 60-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included osteoarthritis, asthma, fibromyalgia. Historical vaccine includes first dose of BNT162B2, Lot number: EL1283, on 14Jan2021 08:45 AM in left arm at the age of 60-years. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. Concomitant medications included etodolac (LODINE); montelukast; amitriptyline; acetylsalicylic acid (BREOPRIN), all were taken for unspecified indication, start and stop date were not reported. The patient previously took Vioxx and experienced allergies. The patient experienced DVT on right leg on 21Feb2021 with outcome of recovered. The event required physician office visit. The patient has not been tested for COVID-19 post vaccination. Therapeutic measures were taken as a result of DVT in right leg which includes Eliquis.

heart attack; This is a spontaneous report from a contactable consumer (patient herself). This 60-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration in the right arm, on 06Mar2021 at 15:30 (Lot number EN6203) as single dose and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route of administration in the left arm, on 27Mar2021 at 15:30 (Lot number EP7534) as single dose, for COVID-19 immunisation. Relevant medical history included allergy to nickel and latex). Past drug history included allergy to penicillin. Relevant concomitant medications included ezetimibe, chondroitin sulfate, glucosamine, biotin and vitamin (unspecified). No other vaccine was received in four weeks. The patient had a mild heart attack approximately two weeks after her first dose of the vaccine (untreated) in Mar2021 and a major heart attack 2 weeks to the day after her second dose (11Apr2021, at 02:00). The patient visited the emergency room and she was hospitalized for 5 days. The event was also considered serious as life-threatening. Therapeutic measures taken as result of the event includes angioplasty. The patient was recovering from the event.

Diffuse muscle pain and fatigue over a 4 week period which led to an ER visit on 4/21/21. Final diagnosis was nontraumatic rhabdomyolysis and patient needed to be treated with IV fluids

multiple pulmonary embolisms/Pulmonary embolism and subsegmental pulmonary embolus; felt sluggish directly; feeling discomfort in my lungs; pain in my lung/chest area; pain in my lung/chest area/right-sided chest pain under the rib; difficult and extremely painful to breathe/significant shortness of breath/shortness of breath due to extreme pain; blood clots; This is a spontaneous report from a contactable consumer (patient) and physician. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EP7534 and expiration date not provided), via an unspecified route of administration, administered in Arm Left second dose on 07Apr2021 17:00 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not pregnant at time of vaccination. The patient's concomitant medications included cetirizine, diphenhydramine, and phenylephrine. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6203), right arm first dose on 10Mar2021 for COVID-19 Immunization. On 07Apr2021 21:30, the patient felt sluggish directly after receiving the second dose. The patient began feeling discomfort in my lungs about 5 hours after the dose. The pain in my lung/chest area grew worse throughout the night to the point where it was difficult and extremely painful to breathe. The patient went to urgent care in the morning, and they ran an EKG, urine analysis, and chest X-ray: all with unknown results. They were concerned it could be something worse along with potential pneumonia, so they sent me to the emergency room. In the emergency room, I received a CT scan where they found multiple pulmonary embolisms (1 large one in my right and multiple in my left lung). The patient stated that she had just had my yearly physical the previous week (Apr2021), with no signs of any health issues. With that, the doctors believed my condition to be related to my 2nd dose, so I was admitted to the hospital. I had to stayed for 2 nights. I am now on blood thinners, other meds (pain medications), and require oxygen during sleep (O2 levels drop too low). I have been referred to lung and hematology specialists. Also, reported that patient experiencing significant shortness of breath and right-sided chest pain under the rib. This persisted for some time until she presented to the emergency department found to have segmental and subsegmental pulmonary embolus. Additionally, the patient experienced blood clots, chest pain, and shortness of breath due to extreme pain. Hypercoagulable work-up pending. The patient underwent lab tests and procedures which included COVID-19 virus test (nasal swab) with result of negative. The outcome of the events was recovering.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events occurred in a plausible temporal relationship. 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.

50 year old female had 1st Covid Pfizer vaccine on 3/18/21 and second dose on 4/14/21. Developed mucosal bleed in tongue and lips. Went to the ER on 4/25/21 and found to have WBC 8.1, Hb 10.2, Plt 10K. Peripheral smear showed thrombocytopenia, no platelet aggregates. WBCs were normal. RBCs showed mild normochromic, normocytic anemia. Patient was started on Prednisone 60mg x 3 days. PLT increased to 75K on 4/27/21 and patient was discharged on 4/27. She was seen in the outpatient clinic on 4/29/21, on Prednisone 50mg . Her Prednisone taper is planned at 50mg x 3d, 40mg x 3d, 30mg x 3 days, 20mg x 4 days, 10mg qd then office visit scheduled again to monitor response. Bleeding spot from the tongue, and lips resolved.

Cardiac Arrest at 1:30 pm on 4/30/2021. . Arrest was witnessed by family and Emergency Medical Personnel. Cardiopulmonary Resuscitation was initiated. Pt was very anxious when EMS arrived.

Cerebral venous sinus thrombosis Patient received vaccine in March (exact date is unknown but around March 8-12 per husband); in mid-April patient started reporting intermittent low intensity headaches. On April 23, patient had severe headache and vomiting, went to urgent care and was thought to have sinusitis and started on antibiotics and discharged home. On April 24th, patient became more drowsy with worsening headache and unresponsive. On April 25, she was taken to outside hospital and was noted to have abnormal brain MRI. She was transferred to our facility on April 26 after clinical worsening. Imaging revealed venous sinus thrombosis in deep cerebral veins and patient was intubated due to worsening mentation. Imaging also revealed a venous stroke with hemorrhage in her left thalamus and diffuse brain edema. Treatment includes extraventricular drain placement, anticoagulation (heparin), hypertonic saline to manage brain edema. We also did extensive workup but no history of hormone therapy, contraceptive pills, underlying cancers. Tumor markers are negative. Hypercoagulable panel and rheumatologic panel are negative. Body imaging did reveal multiple uterine fibroids but no other cancer. Patient remains in the ICU, on the ventilator, heavily sedated for management of refractory intracranial hypertension.

Anaphylactic reaction; it started like a flushed feeling; She felt woozy; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she still feels a little tight in her throat/she does feel tight, scratchy, and hoarse; she is just a little uncomfortable, just a little today, not too bad; She adds that she is having a hard time focusing; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8731 and expiry date unknown, Solution for injection), via an unknown route on 12Apr2021 at 15:05 (at the age of 60-years-old) at single dose on left arm for COVID-19 immunization. Relevant medical history included allergies, asthma, she had anaphylaxis in the past to allergies. (Unspecified allergens). The patient added that she had issues for about a year before her surgeon had to do a surgery on her throat. She added she was fortunate because her thyroid was in her airways 14 years ago and her body exploded with allergies and her throat closed a lot. When the doctor did the surgery, the doctor opened her throat up more so that if she had another anaphylaxis it would not result in death. Concomitant medications was not reported. On the same date, after the vaccination the patient had anaphylactic reaction. She stated that happened 62 minutes, it might have been 64 minutes and also stated a few minutes after 60 minutes. The vaccination facility released her after 30 minutes at 15:35 and when she realized something was happening it was 16:10 when the patient realized what it was that she was experiencing. The vaccine facility held onto her for 30 minutes, so she got the vaccine around 15:05 and they watched her for 30 minutes. She believed it was around 65 minutes later that she started noticing something was happening. The patient started like a flushed feeling. She does not know to describe it, it was like she had a drink or something like she felt flush or something over her system like a wave or something. It was like a strong drink or something. She does not drink a lot but it was like woohooo, a wave of something, and then she felt woozy. It was not too bad at first, she was at a bank drive through and she was not driving. The patient was going to pick something up so she stopped for 5 to 10 minutes. She was on the phone with a friend. She felt woozy. The patient asked her husband to buy diphenhydramine (Benadryl). Her husband called back when she got done at the bank, and she was only 10 minutes from her house. The patient had her EpiPen with her. The patient was feeling better and she still feels a little tight in her throat and the way she explained it yesterday was that it was like someone had their finger down her throat, it was uncomfortable. She was just a little uncomfortable, just a little today, not too bad. She added that she was having a hard time focusing. Today, the patient felt tight, scratchy, and hoarse. It was not like it was last night. The patient did not receive any treatment for the events. Outcome of the events were unknown. Description of Product Complaint: Description of complaint: Consumer reporting an AE for the Pfizer COVID 19 vaccine mentions that they told her not to take the flu vaccine because she would get sick. Her flu symptoms would go on for 2-3 months. If she got the flu shot in September or October, she would not feel well through Christmas. Caller adds that she never got the flu again when she stopped the vaccine. Caller does not know manufacturer, NDC, lot or expiration date for the flu vaccine she had that made her sick Caller does not have any information about the Benadryl - and she does not have the bottle that she took that made her sleepy because she added that the only bottle she had was the one that her husband bought yesterday and it was not opened and she had not taken it. Caller added that she had not taken Benadryl in 14 years since before her surgery. Caller adds it might have been 15 years, she would have to remember that. AE identified after call completed. No NDC, lot or expiration date provided for Benadryl caller took 14 to 15 years ago. Follow-up attempts completed. No further information is expected.

anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.

Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency room; couldn't swallow; right side of the patient's face swelled up and her lips were numb; right side of the patient's face swelled up and her lips were numb; face numb; hands itching; tongue had swelled up; voice was scratchy; This is a spontaneous report from a contactable consumer, Reporter's sister via Pfizer-sponsored. A 60-year-old female patient received the second dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Ex-piry Date: Unknown) via an unspecified route of administration on 01Mar2021 on an unknown ana-tomical location as a single dose for COVID-19 immunization. Caller provided that her sister got the vaccine for COVID Prevention and because the patient has a handicapped, bedridden husband who has MS and is immune compromised, and it was to help prevent him from getting sick. Caller reported that the patient received the product during the daytime, all the women at the patient's job, which was home health payroll, everyone left to get the vaccine during work hours, like in the AM at around lunch time. Patient's medical history and concomitant medications were unknown. Patient has not received any prior vaccinations within 4 weeks. Patient had no other vaccines on the same day as the suspect product. Patient received first dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Expiry Date: Unknown) on 08Feb2021 with no reaction. She worked for a health agency and the whole office went and got it. Caller provided that her sister had a reaction the first time, on 03Apr2021, where her sister woke up with itching started in her hands and ended up migrating to her whole body. By morning patient's tongue had swelled up, couldn't swallow and her voice was scratchy, like the caller couldn't understand her sister's speech well. Caller provided that her sister went to the ER and said there was a whole team giving her urgent care, medication, and such. Caller reported that her sister said the ER didn't find anything in her bloodwork, and the caller did not think the patient was being treated for any other medical conditions, and caller did not think her sister is on any medications, but caller said to not quote her on that. Caller knew her sister had a weight problem, but she did not know if her sister needed blood pressure medication or anything. Caller reported her sister said that the bloodwork from the ER did not find any-thing, and the patient was not admitted to the hospital. Caller reported that at this time, her sister's adverse events were no longer ongoing as her sister was given Steroids, like Prednisone, Benadryl and Famotidine, and she took those products as recommended by the doctor. Caller did not know the end date of her sister's events; all she knew was that the reaction initially started on 03Apr2021. Caller stated that her sister was allergic to nothing, and she has never had incidences of itching like that, where the itching was so bad that she was stripping down and the patient's daughter was patting the patient down with witch hazel. Caller stated that ER released the patient and gave her some medications and such. Caller stated that a day or so later, there was a second round of reaction: the right side of the patient's face swelled up and numb and her lips were numb, like when people have a dental procedure. Lips were numb for a while. Upon completion of the medications she was given, the reactions stopped. Patient regularly saw the family doctor. She would go back to see her Doctor on Thursday. HCP Information was unknown to the caller, but caller stated that her sister had been recommended to go to her PCP and get an Epi Pen. Caller stated that knock on wood, so far, her sister was holding her own, and it had not happened again. Caller stated that she was reporting the data that her sister gave to her after having the Pfizer vaccination. Caller stated the patient had an anaphylactic reaction twice that caused her to go to the emergency room. No relevant tests were done. Caller stated that she had the dates that she had her shots and where she had her shot at. Caller stated somebody called and reported it already. Caller stated she was trying to press three but never could figure out which prompts was. Caller stated they said if she called this number, they would tell her at the medical information department if this occurrence has happened to other people, like statistics. Caller stated they tried to call this number, but it was too long of a wait. Caller stated that she did not have the vaccination card, she never asked for them. Caller does not have card with her at time of call for LOT, NDC, Expiry date. Caller stated that she knew that all the COVID vaccines are just in the Emergency Use Authorization stage and in clinical trials, but caller really thought that all manufacturers should be advertising that they would like feedback from patients. Caller has not heard anything from any of the manufacturers saying that people are welcome to reach out and report side effects. Caller states that she only knew to call because she used to be a Home Health Worker, and she thought this is an important data. Caller has never seen on any of her 19 TV channels about calling to report. Caller stated that the girl who first answered her call, read a clinical data sheet about joint pain being seen in 23% of patient's and not knowing a percentage for anaphylactic reactions, caller was wondering if this was true. Caller verified that she just wanted to ask basically that patient was not alone, if other people might have had that happen too. Caller stated that she tried to call, and it would ask another question and it would say press 1 or 2, then it would ask other questions and it would say press 1 or 2, she never got an option 3. Caller asked: how much percentage, has anyone reported this side effects weeks after the second dose. Caller was wondering if this reaction could have been from the vaccine. Investigation Assessment: No. The outcome of the events were unknown. Information on the lot/batch number has been requested.

DVT blood clot; ankle was still swollen and uncomfortable; ankle was still swollen and uncomfortable/discomfort; nights were the worst for the pain; pulse ox was low; d-dimer was very high; fainted; Fracture of ankle/two fractures on her ankle; severely nauseous; Vomiting; Diarrhea; deathly sick; This is a spontaneous report from a contactable consumer, reporting for herself. A 60-year-old female patient received the first dose of the bnt162b2 (BNT162B2; Lot Number: ER8727), via an unspecified route of administration in the left arm on 26Mar2021 at 14:00 at a single dose for covid-19 immunisation. Medical history included osteoporosis at least 10 years, terrible nausea, mild case of covid from Nov2020 to an unknown date. There were no concomitant medications. The patient previously took alendronate from 2008 to an unknown date and experienced very sick, nausea, diarrhoea and zoledronic acid (RECLAST) from Dec2017 and experienced nausea and vomiting. On 27Mar2021 at 2:00, the patient experienced deathly sick, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, and diarrhea. On an unknown date, the patient experienced dvt blood clot, ankle was still swollen and uncomfortable/discomfort, the nights are the worst for the pain, pulse ox was low, and d-dimer was very high. The event, deathly sick, was life-threatening. The clinical course was as follows: the patient had the first dose of the vaccine on 26Mar2021 at 14:00 in the afternoon in her left arm. Twelve hours after the first dose, later in the night about 02:00 AM she woke up deathly sick; and severely nauseous. She remembered she was going to the bathroom then she must have fainted because they were taking her to the hospital. She went to the ER and they found she had a fractured ankle. She was not admitted to the hospital. She was in the ER from about 03:00 AM to noon the next day. There must have been something in there; she knew there must be something in the vaccine because of her reaction. Adds a few years ago, something like this happened before. She had osteoporosis and had similar reactions with other products she had tried for osteoporosis; she had terrible nausea. The other products she tried included: in 2008 she took alendronate, it made her very sick but not as severe as this time, she never fainted. She had nausea and diarrhea. Then in Dec2017 she had zoledronic acid. She went for an infusion at the hospital then went shopping, and was fine until the early morning, when she woke up with nausea and vomiting. In the ambulance, they gave her ondasetron (ZOFRAN) for the nausea so the vomiting stopped. With regard to her ankle, first they thought it was a DVT blood clot. They did the xray and saw actually two fractures on her ankle but she does not need surgery. She saw the orthopedic doctor the other day and he said her ankle was healing but she still will have no weight bearing for 6 weeks and she was in a boot. Adds her ankle was still swollen and uncomfortable. She hated to take medications and they gave her oxy but she didn't want to take it. She was taking ibuprofen but that messed up her stomach. The nights are the worst for the pain and discomfort. Doctor at the hospital and primary care agreed she should not have the second dose. She did have mild case of COVID in Nov2020 and they are hoping she had antibodies from the infection and the first dose. Her primary care doctor was reviewing the blood work she had done at the hospital and told her they were surprised the hospital didn't admit her for observation because her pulse ox was low and there was another test that she was questioning because the d-dimer was very high. They did a chest x ray with unknown results. The doctor was questioning why they didn't do something else to rule out a blood clot. Therapeutic measures were taken as a result of the events, deathly sick, DVT blood clot, fainted, fracture of ankle/two fractures on her ankle, severely nauseous, vomiting, diarrhea, ankle was still swollen and uncomfortable/discomfort, nights were the worst for the pain, pulse ox was low, and d-dimer was very high. The clinical outcome of the events, deathly sick, fainted, severely nauseous, vomiting, diarrhea, was recovered on 27Mar2021. The clinical outcome of the events, DVT blood clot and nights were the worst for the pain, pulse ox was low, and d-dimer was very high, was unknown. The clinical outcome of the event, fracture of ankle/two fractures on her ankle, was recovering. The clinical outcome of the event, ankle was still swollen and uncomfortable/discomfort, was not recovered. No follow-up attempts are needed. No further information is expected.

4/9/21 Pt had URI symptoms. She was seen at a Minute Clinic. Tested negative for Sars-Co-V-2 4/12 Had continued symptoms. Test positive for SARS-CoV-2 4/15 Treated with mAB 4/17 Presented to ED w/nausea and decreased appetite. Vitals stable. No hypoxemia. +electrolyte imbalance K+ was 2.9. Given IFV and K repletion and discharged to home 4/19 Started on Zpack and Decadron as outpt 4/21 Returned to ED with increasing SOB and reported home pulse ox 75-82% w/ exertion. In ED, sats in low 90's. Tachypnea with RR24-28. CTA + for PNA and new PE Discharge summary : Pulmonary embolus Likely secondary to COVID-19 infection; HRT possibly contributing Chest CTA showed a small subsegmental pulmonary embolus in the left lower lobe. Flattening of the interventricular septum possibly indicating acute right heart strain Lovenox 1 mg/kg twice daily in the hospital and transitioned to Eliquis at discharge Patient currently on estrogen placement therapy-discontinued Covid-19 Virus Infection Date of onset of symptoms: 4/9/2021 Symptoms present on admission: Productive cough, dyspnea Date of covid positive test: 4/12/2021 Vaccination status: First dose given on 3/31/2021 Special isolation anticipated end date: 4/22/2021 if symptomatically improving Imaging: Chest CTA with interval worsening of diffuse interstitial infiltrates Oxygen requirements on admission: Room air Current oxygen requirements: Room air Medical therapy: Continue oral Decadron 6 mg daily Consultants following: None Inflammatory markers: LDH 306, ferritin 507, CRP 54.3 and D-dimer 2.07 Disharged on codeine cough syrup and Tessalon for persistent cough

1/7/2021 vaccination 1/8/2021 bruise/pain R lower leg, hard warm to touch. Painful and sore. Progressively got worse; red, bluer. 1/10 or 1/11 ER . Ultra sound on leg. 10cm clot. Put me on aspirin, warm compresses. Had to increase aspirin up to 2x day. It eventually cleared. Referred to surgeon. Found some other veins their inspecting further. *have not had any more clots

patient with unprovoked large left lower extremity DVT and bilateral PE with moderate/high clot burden. Platelet count was normal. Hemoglobin was still low at 9 but improving with iron supplementation over the last month. She does not have a previous history of blood clot or family history of blood clot or hypercoagulable state.

Same-day reactions -within 5 minutes: hives in face and neck - a few more minutes later: swollen lips (had to take Benadryl and 20 mg of prednisone that I was carrying because the hospital only had the epipen) - within 24 hours: shortness of breath, palpitations - couple of days later: admitted to the ER with pneumonia and PVC arrhythmia

Anaphylaxis (lip swelling, generalized hives, shortness of breath) within 30-45 minutes of vaccine. Because patient has a history of anaphylaxis, she was able to treat it by giving herself epinephrine, oral antihistamines, and nebulizer treatment with levalbuterol every few hours for the next 3 days. She recovered and did not report this until 5/12/21.

Patient tested positive for COVID on April 12th after having received both COVID-19 vaccines - pfizer. Patient has known COVID19 exposure from her son and was COVID19 positive in April. The patient had a positive asymptomatic COVID-19 test. Patient was tested prior to planned colonoscopy. The patient completed 10 days of quarantine until April 22. Patient presented to hospital (sister hospital) on May 2nd after 1 week of fevers and productive cough. At MSQ patient received cefepime/vancomycin/doxycycline for CAP. She initially improved, but on 5/5 she had recurrent fever with rapid decline, her respiratory status requiring 2L of NC to HFNC to NRB. CXR with B/L opacifications. CTA chest was negative for PE, but patient with diffuse groundglass and consolidative opacities. Also had TTE that showed LVEF 71% and grade 1 diastolic dysfunction. She was evaluated by MSQ Infectious Diseases physician and was started on bactrim for PCP prophylaxis and resumed on broad spectrum antibiotics. She was also evaluated by rheum in sitting of her SLE and patient was started on prednisone 40 mg q8h methylprednisolone for potential SLE flare. Continued on cefepime and vancomycin. Patient was transferred to Hospital due to worsening respiratory status and tested positive for COVID-19 at MSH on 5/9. Admitted to the MICU, patient received a loading dose and one 100 mg dose of remdesivir - stopped due to elevated liver enzymes. On 5/16 extensive new ischemic/hemorrhagic strokes throughout intracranial vascular distribution, DIC d/t COVID vs AF and intubated for mental status changes. Patient's clinical picture worsening - requiring pressors. Chest x-ray with diffuse ground glass opacities, ARDs and pulmonary edema. Patient remains in critical condition in MICU as of 5/19.

Atrial fibrillation started, one hour after vaccine. Rushed to ER, Electrical Cardioversion given Experienced Vertigo, 18 hours after vaccine.

Please check with her doctors. I know she mentioned Myocarditis. She was vaccinated I am correct, on March 8 and April 6, 2021

Started spot vaginal bleeding like I was getting my period. I have not had a period for 15 years. Menopause at age 45. Bleeding enough to note, but not enough to cause concerns. Bleeding stopped 24 hours later, this morning 5/25 - 7am.

Patient received COVID-19 vaccine on 4/3/21 subsequently admitted from 4/10-21-4/12/21 for acute pericarditis.

anaphylaxis; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20May2021 11:00 (Batch/Lot Number: EW0165) as single dose for covid-19 immunisation (age at vaccination was of 60 years). Medical history included rheuatoid arthritis, surgical asplenia. Patient also allergic to Pineapple. No other vaccine was recieved by the patient in four weeks. The patient received other concomitant medications in two weeks. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 14:30 (Batch/Lot Number: EW0169) as single dose for covid-19 immunisation (age at vaccination was of 60 years). On 21May2021 12:15, the patient experienced short of breath, increasing difficulty breathing, anaphylaxis, in order hoarseness, voice sounds like laryngitis, in order hoarseness, voice sounds like laryngitis, lips tingling, eyes swelling, wheezing, dizziness. Patient took 50mg Benadryl at 12:30 with no relief and went to ER. The ER (emergency room) diagnosed anaphylaxis and started treatment at 13:37. EpiPen, famotidine (Pepsid), SoluMedrol PF was given as treatment. Patient recovered with lasting effects. No covid prior vaccination was reported. Patient was not tested for covid post vaccination. Outcome of all events was recovered with sequelae. Follow up attempts are needed. Further information has been requested.

Migraine, Seizure, Grand Mal, could not move out of bed, low awareness for 2 weeks. Took 3 months to get to walk. Dizzy and off-balance, nausea

Seven hours after the vaccine I began vomiting, followed by diarrhea and indigestion that lasted for two days May 28th and 29th 2021.

Within 5 weeks of receiving the second dose of Pfizer Covid vaccine, (on April 3, 2021) the patient developed unprovoked SVT to 200 beats per min & then within 24 hrs had an acute Non-ST segment MI, with accompanying chordae tendineae rupture of her Mitral Valve. Required emergent Cardio conversions and Mitral Valve replacement.

Possible anaphylactic shock, acute kidney injury, shock liver, hypotension, rash, thrombocytopenia. Full body rash, abdominal pain, vomiting, diarrhea, RLE pain, fever, dizziness, body aches, headache. Sx onset 06/26/2021 after receiving COVID vaccine #2 the same day. Pt went to medical facility on 06/30/2021 and was sent to ED. Pt admitted to ICU 06/30 - 07/02. Transferred to general medical floor on 07/02/2021.

Vagina Bleeding and cramping; Vagina Bleeding and cramping; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6203, Expiry date: not reported, age at the time of vaccination: 60-year-old), via an unspecified route of administration, administered in Arm Right on 17Mar2021 08:15 as dose 2, single for covid-19 immunisation in facility. Medical history included High Blood Pressure, known allergies include Penicillin, Menopause (I have been post menopause for over 15 years.) Concomitant medication within 2 weeks included metoprolol succinate (TOPROL XL) at 50 mg. Previously the patient received first dose of bnt162b2 (Lot number EN6198), in Arm left on 25feb2021 12:00 for covid-19 immunization. On 17Mar2021 20:00, patient experienced vagina bleeding and cramping and the patient had received a treatment as she had contacted her physician. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19, prior to vaccination and since the vaccination. The outcome of events was not recovered.

Sore Right Arm and swollen vein ; ultrasound confirmed a blood clot in Right Arm. Trip to ER 6/30/21; put on blood thinner. No history of blood clots.. self or family. 2nd vaccine shot was 6/22/21 LOT EW0217

Bi-Lateral Pulmonary Embolisms, Left Leg Deep Vein Thrombosis Noticed Symptoms on 5/28/2021 Hospitalized on 6/2/2021

This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-year-old female patient received BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER8729, Expiration Date: UNKNOWN), via an unspecified route of administration, in left arm, on 19Apr2021 (at the age of 60-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included atrial fibrillation from Jun2020 and ongoing patient stated she was diagnosed after the heart surgery, heart surgery on 20May2020 patient stated she had a new Tricuspid valve placed and she was in the hospital for two weeks during the surgery and she was still having some problems from the heart surgery, ongoing BP elevation patient stated about two weeks ago, her heart doctor kept her on a blood pressure medication, and she cannot provide the name, stroke on 27Feb2020 and ongoing, had hole in heart from birth and unknown if ongoing. The concomitant medications of the patient included apixaban (ELIQUIS) taken as blood thinners from Jun2020 and ongoing and metoprolol (METOPROLOL) taken for heart issues from Jun2020 and ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: ER2613, Expiration Date: UNKNOWN), via an unspecified route of administration, in left arm, on 26Mar2021, as single dose for COVID-19 immunisation and she also received flu shot on an unspecified date in Oct2020 (at the age of 59-years-old) and reported arm sore. There was no investigation assessment. There were no additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The family medical history relevant to AE(s) was not provided. The relevant tests were reported as none. AEs prior vaccination was reported as arm sore. On 04May2021, the patient reported she's had severe arm pain on the arm with the injection (left). She stated she is still having the pain. it's like someone punched you in the arm with their fist, the pain was running my blood pressure so i had to go to the hospital/blood pressure elevated, 212/109 and atrial fibrillation on an unspecified date. The patient reported that her arm hurt so bad, pain, cannot put her arm behind her back, after second vaccine, it had been over 2 months since her arm hurting her, and she went to the emergency room and her blood pressure went way up and she had some heart issues and had atrial fibrillation two to 3 weeks after the second shot, and it lasted one day. She asked how long the pain will last and was anyone else reporting arm pain for this period of time. The patient was hospitalized as a result of events from 06May2021 to an unknown date. The patient visited emergency room. The patient underwent lab tests and procedures which included Blood Pressure elevated: 212/109 on 06May2021. Therapeutic measures were taken as a result of events that included, she took Tylenol. She reported that she was given medication in the hospital, cannot provide the name and the medication did help to bring her blood pressure down and she also did get a shot of a steroid states the steroid did help to relieve some of the arm pain. The outcome of the events having the pain. it's like someone punched you in the arm with their fist and the pain was running my blood pressure so i had to go to the hospital/blood pressure elevated, 212/109 was reported as unknown and the patient recovered from atrial fibrillation on an unspecified date in 2021. Follow-up attempts are completed. No further information is expected. ; Sender's Comments: A causal association between BNT162B2 and the reported events atrial fibrillation, blood pressure increased and pain in arm cannot be completely excluded based on information provided. However, patient's underlying medical conditions atrial fibrillation, septal defect, heart surgery, hypertension and advanced age were confounders. 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.

Congestive heart failure; This is a spontaneous report received from a contactable consumer (Patient). A 60-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 30Mar2021 11:00 (at the age of 60-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, cardiac disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot: unknown) on 10Mar2020 at 11:00 PM in the right arm for COVID-19 immunisation and experienced shortness of breath. The patient experienced congestive heart failure on Jun2021. The events assessed as serious (medically significant). Call was from two sisters, a 57 year old female and a 60 year old female. One received her Pfizer Covid-19 vaccine on 22Jun2021 and started experiencing shortness of breath and dyspnea. The other sister received the Pfizer Covid-19 vaccine on 10Mar2021 and starting experiencing shortness of breath as well but attributed to her history of atrial fibrillation initially. Both are wondering if anyone else was having these complaints and if there are any recommendations for the complaints. Patient mentioned while providing family history, her sister had the COVID 19 vaccination and also had shortness of breath. Adds her sister got her vaccination in Mar2021 but she does not had her card with her. She also had shortness of breath and was still having it. She did not put two and two and together until her sister had it. This was a clone report was created to document the sister's experience. Patient adds the shortness of breath that started in Mar2021. States she had previously been off work for a year with A-Fib but she was doing really well, she had started walking around the block and everything. Reports she was unsure of exactly when she noticed the shortness of breath. She went from the car to the store and she was short of breath so she went to the emergency room to get it checked but everything was good. Mentions she was also diagnosed with congestive heart failure about a month ago. After she went to the emergency room she just went back and forth to her doctors. The lung doctor said she was okay and the heart doctor, too. She kept going to the doctor because it did not dawn on her that the shortness of breath might be related to the vaccination until her sister got her vaccination and had the shortness of breath. Now she believes she noticed the shortness of breath after the first dose. Mentions she has the emergency room records and her vaccination card at home to verify her information. Adds she was talking to a guy at the bus station and he had shortness of breath too. She does not know this person and declined to report regarding the guy at the bus station. Patient visited Emergency Room, but not admitted. Patient visited physician Office. The patient underwent lab tests and procedures which included blood test: good, chest x-ray: good, electrocardiogram: good on More information available (Y/N): No. The outcome of the events was reported as unknown. Information on the Batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021829874 same reporter/drug/event, different patient

Congestive heart failure; shortness of breath; This is a spontaneous report received from a contactable consumer (patient sister). A 60-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was Unknown), via an unspecified route of administration, administered in Arm Right on 10Mar2021 11:00 (at the age of 60-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, heart disease. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021, the patient experienced shortness of breath, time of onset: (24-hour clock) was unsure but possibly after the first dose. On an unspecified date congestive heart failure. Patient called regarding the Pfizer COVID 19 vaccine mentioned while providing family history, her sister had the COVID 19 vaccination and also had shortness of breath. Added her sister got her vaccination in Mar2021 but she doesn't have her card with her. She also had shortness of breath and was still having it. She do not put two and two and together until her sister had it. This was a clone report is created to document the sister's experience. Patient added the shortness of breath that started in Mar2021. States she had previously been off work for a year with AFib but she was doing really well; she had started walking around the block and everything. Then she had the first dose of the Pfizer COVID 19 vaccine on 10Mar2021 at 1100AM in the right arm; and the second dose 30Mar2021 she thought at 1100am in the right arm. Reports she is unsure of exactly when she noticed the shortness of breath. She went from the car to the store and she was short of breath so she went to the emergency room to get it checked but everything was good. Mentions she was also diagnosed with congestive heart failure about a month ago. After she went to the emergency room she just went back and forth to her doctors. The lung doctor said she was okay; and the heart doctor, too. She kept going to the doctor because it do not dawn on her that the shortness of breath might be related to the vaccination until her sister got her vaccination and had the shortness of breath. Now she believed she noticed the shortness of breath after the first dose. Mentions she has the emergency room records and her vaccination card at home to verify her information. Adds she was talking to a guy at the bus station and he had shortness of breath too. She could go get the test results when she gets the information and had blood, EKG, and chest x-ray; they said was it was good. Mentioned she was still pressing the issue about her breathing but they couldn't detect it. History of all previous immunization with the Pfizer vaccine considered as suspect. Additional vaccines administered on same date of the Pfizer suspect was none. No vaccine administered at Facility. The patient underwent lab tests and procedures which included blood test, chest x-ray, EKG: was good on an unspecified date. Events resulted in emergency room visit and physician office visit. The clinical outcome of events shortness of breath was not recovered and congestive heart failure was unknown. Information about batch/Lot number has been requested.

This is a spontaneous report from a contactable consumer (patient's sister) or other HCP. This is 1st of 2 reports.A 60-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration at Arm Right on 10Mar2021 at 11:00 (at the age of 60-years-old) as Dose 1, single for COVID-19 immunization. The patient's medical history included atrial fibrillation, cardiac disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other products were used.On an unspecified date the patient experienced congestive heart failure and shortness of breath on an unknown date in Mar2021. The patient underwent lab tests and procedures which included blood test: good on, chest x-ray: good on, electrocardiogram: good on. Outcome of the event was cardiac failure congestive was unknown, shortness of breath was not recovered on unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Gota a transient scheme stroke on April 8th,2021 when a blood clots went to my right side brain. I was shown by an MRI , when I was admitted to the ER. I Was hospitalized for 3 days and all the hospital test and future cardio and neurological tests not shoed any reasonable causes for developing the blood clothes and a stroke , as the Lipid test as well showed that my cholesterol, blood pressure ,weight and sugar level were in normal ranges. Given that Y have a family history of cardiovascular conditions I maintain councioly my good health condition,the only different in my health was getting my second dose of the Pfizer vaccine on March 19,2020 three weeks before I developed the schema stroke.

New onset eczema- Filed earlier report about being bitten by fire ants two weeks after second covid shot and having anaphylactic reaction with no prior history of insect bite allergies and have been bitten alot including the harvester ant. Now have epipen. Then started fire ant shots in June and developed butt tingling/numbness and muscle and body aches after 2nd fire ant shot. By third shot on on July 1st, I had fatigue, extreme musculoskeletal pain and developed a rash. It was really scary so went to the allergist who referred me to my GP. She thinks it is serum sickness. Saw the dermatologist today about the rash and it started about 3 to 4 days after the third fire ant shot. I have never had eczema in my life either. After three weeks from July 1st, am starting to feel better. Not sure if serum sickness caused by molecular mimicry hypersensitive immune syndrome caused by Covid vaccine or not, but there are a lot of immune mediated things happening to me in less than 3 months. My brother developed pericarditis after the second Pfizer shot and I told him to file a VAERS as well.

Initial problem 2/8/21 pericarditis. Hospitalized 2 days. Started on colchicine, metoprolol and rosuvastatin, pain medications. EC 4/12/21 for DVT; Admit 4/16/21 for worsening DVT in right leg.

pneumonia; loss of consciousness; difficulty in breathing; feeling weak; diarrhea; Arm fracture; Fall; This is a solicited report received from a contactable consumer (patient) based on the information received by Pfizer. (MFR Control No. # 21K-163-3955081-00). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 26Apr2021 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation; adalimumab (HUMIRA 40MG/0.4ML, Solution for injection in pre-filled pen), subcutaneous from 03Apr2020 (Batch/Lot number was not reported) to Mar2021, at Citrate Free (40 mg,1 in 2 wk), subcutaneous from Mar2021 (Batch/Lot number was not reported) and ongoing, at 40 mg for Ulcerative Colitis. Medical history included tobacco user: one pack of cigrette per day (Started 1978), abstains from alcohol. Concomitant medications included tizanidine; carvedilol (COREG); pregabalin; atorvastatin calcium (LIPITOR) taken for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS). The patient previously took hydrocodone. The patient experienced loss of consciousness on May2021 with outcome of recovered on May2021, pneumonia on 05May2021 with outcome of recovered in 2021, feeling weak on 27Apr2021 with outcome of unknown, difficulty in breathing on 27Apr2021 with outcome of unknown, diarrhea on Mar2021 with outcome of recovered in 2021, arm fracture on 27Feb2021 with outcome of recovering, fall on 27Feb2021 with outcome of recovering. Clinical course: In 2021, the patient experienced chest tube had been drained and removed. On 27Feb2021, the patient experienced broken right arm in two different places and fell. In Mar2021, the patient experienced diarrhea. in May2021, the patient experienced loss of consciousness. on 05May 2021, the patient experienced pneumonia. in May 2021, the loss of consciousness resolved. in 2021, the pneumonia and diarrhea resolved. Covid-19 vaccine was also considered suspect. the patient shared that she fell in 27Feb2021 and broke her right arm so she went to the emergency room. Her x-ray revealed that she broke her arm in two different places. she was then asked to meet with an orthopedic surgeon and was scheduled for an out-patient procedure to repair her broken arm with pins and plates on the second week of Mar2021. she was sent home and was given hydrocodone for pain. she also added that the physician placed her humira on hold two weeks prior and after the procedure. because of humira was placed on hold, she experienced diarrhea for a week until it resolved. she received her first dose of her covid-19 vaccine in 26Apr2021. she noticed that she started feeling weak and had difficulty in breathing the next morning. she was rushed to the hospital in 05May2021 because her weakness and difficulty of breathing worsened. a series of unrecalled tests had been performed including chest x-ray which showed that she had pneumonia. she was then admitted and was hooked up to a machine because she had difficulty in breathing. she added that she could not recall any other treatments or diagnostic tests that was done to her because she was unconscious for three weeks and was monitored in the intensive care unit. she added that her chest tube had been drained and removed the day she got released in the hospital. she was sent home in 25May2021. alternative etiology of pneumonia, weakness, loss of consciousness, difficulty breathing were reported as covid-19 vaccine.it was unknown if patient was enrolled in a covid-19 vaccine trial. The action taken in response to the events for bnt162b2 was not applicable, for adalimumab was unknown. Causality for humira 40mg/0.4ml(adalimumab)-the reporter's causality for the event(s) of loss of consciousness, broken right arm in two different places, pneumonia, fell and diarrhea with humira 40mg/0.4ml(adalimumab) was no reasonable possibility. the reporter's causality for the event(s) of chest tube had been drained and removed was not provided. Programs opinion is that there is no reasonable possibility that the events of loss of consciousness, broken right arm in two different places, chest tube had been drained and removed, pneumonia, fell and diarrhea are related to humira 40mg/0.4ml(adalimumab). COVID-19 VACCINE (COVID-19 VACCINE)(Injection) (COVID-19 VACCINE), Causality: Loss of consciousness-Causality as per reporter (Drug/Vaccine): Probable; Arm fracture-Causality as per reporter (Drug/Vaccine): Not Related; Pneumonia-Causality as per reporter (Drug/Vaccine): Probable; Fall-Causality as per reporter (Drug/Vaccine): Not Related; Diarrhea-Causality as per reporter (Drug/Vaccine): Not Related. The reporter's assessment of the causal relationship of the events (feeling weak, difficulty in breathing) with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the plausible temporal relation, the association between the events of loss of consciousness, pneumonia, asthenia and dyspnoea and the suspect product of BNT162B2 cannot be completely ruled out. The confounding factor for the event of pneumonia is the co-suspect drug Humira Due to implausible temporal association, the events of diarrhoea, arm fracture and fall are assessed as unrelated to BNT162B2 The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Patient hospitalized for bacteremia, severe sepsis with acute organ dysfunction within 6 weeks of receiving covid vaccination.

coughing up blood, significant hemoptysis -- > cardiac arrest. started day after vaccine but likely related to ongoing progression of lung cancer

Systemic: Anaphylaxis-Severe, Systemic: Fainting, Systemic: Pharmacist submitting: unable to determine if anaphalaxis or panic attack, patient experienced facial weakness, chest tightening, tremmors, inability to breathe, and fainting within 10 min of administ

Client was being treated with antibiotics by her PCP for diverticulitis flare up. It had not been resolved on the date of her death which occurred 01/27/21, She was found unresponsive by staff, 911 contacted, and paramedics pronounced her deceased at 7:48 AM. After consultation with PCP manner of death was noted as cardiac arrest. PCP was to sign off on death certificate.

Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 3 mins after vaccination, pt reports nausea, dizziness, chest pressure, and profound weakness. Brought to Emergency Department by crisis RN where she remains achy with weakness, fatigue and had no energy. Pt reports "feeling tired" and "my speech is slower". On exam, slight R facial droop noted, tongue noted to be leaning towards the right, pronator drift noted in R arm. Code Brain activated with real time audio video interaction. MRI completed with normal results. Symptoms resolved. Stroke team ok with discharge to home with f/u with PCP.

61 yo F with history of bilateral lung transplant 6/23/17 presented to ED on 2/4/21 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine (Pfizer) on 1/28/21. Upon arrival to triage she was obviously dyspneic with significantly low oxygen saturations. O2 sats on arrival were 65%, improved to mid 90's with O2 6 liters per NC. Admitting diagnosis: hypoxic respiratory failure post COVID vaccine. Lab work shows an elevation of the BUN and creatinine at 31 and 1.71 which is slightly higher than her usual baseline levels. BNP is elevated at 2 448 with a mildly elevated troponin. Procalcitonin is also elevated. Patient's white blood cell count is 11.07. Full viral panel including COVID-19 is not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, Thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 2/8/2021 and then VV ECMO cannulation on 2/13/2021. EGD done 2/14/2021 as unable to pass the TEE probe during cannulation prior day (unable to complete due to abnormal anatomy). Acute pupil exam change in the early am hours of 2/15/2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. GOL engaged and patient not an organ donation candidate. Therefore discussion with sister at bedside resulted in decision for cessation of life support. Patient expired shortly after support withdrawn and pronounced dead on 2/15/2021 at 11:11 AM.

chest x-ray shows numerous bilateral patchy opacities; catastrophic brain bleed; Brainstem reflexes were lost; Patient died; shortness of breath; nausea; diarrhea; worsening shortness of breath/numerous bilateral patchy opacities; immunosuppressed status; This is a spontaneous report from a contactable pharmacist and a contactable other health professional. A 61-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular at arm right on 28Jan2021 (at the age of 61 years) at single dose for COVID-19 immunization. The patient medical history included bilateral lung transplant on 23Jun2017, lymphangioleiomyomatosis, hepatocellular carcinoma, antibody mediated rejection of lung transplant , bronchiolitis obliterans syndrome, grade 0P, major depressive disorder, RLS (restless legs syndrome), chronic insomnia, long term current use of systemic steroids OSA (obstructive sleep apnea), iron deficiency anemia, bilateral sciatica, hoarseness of voice, memory change, laryngeal stridor, pure hypercholesterolemia senile nuclear cataract, bilateral myopia of both eyes, osteoporosis without current pathological fracture, alopecia, immunosuppressed status, all from an unknown date and unknown if ongoing. Concomitant medication included acyclovir (formulation: capsule, strength: 200 mg) oral at 200 mg twice daily, salbutamol (ALBUTEROL HFA) as needed (MCG/ACT inhaler take 2 puffs by inhalation every 4 hours as needed) for wheezing (shortness of breath), atorvastatin (LIPITOR, formulation: tablet) oral at 80 mg once a day, azithromycin (ZITHROMAX, formulation: tablet)oral at 250 mg (every Monday, Wednesday, Friday), bupropion hydrochloride (WELLBUTRIN XL, formulation: tablet, strength: 150 mg) oral at 150 mg once a day, calcium citrate/cholecalciferol (CALCIUM + VITAMIN D, formulation: tablet) oral at 2 dose form once a day (every morning), everolimus (ZORTRESS, formulation: tablet, strength: 1 mg) oral at 2 mg twice a day, fluticasone propionate/salmeterol xinafoate (ADVAIR, strength: 500 ug/ 20 ug) twice daily (1 puff by inhalation), gabapentin (NEURONTIN, formulation: capsule, strength:100 mg) oral at 300 mg daily (by mouth nightly), loratadine (CLARITIN, formulation: tablet, strength: 10 mg) oral at 10 mg as needed, metoprolol tartrate (LOPRESSOR, formulation: tablet, strength: 25 mg)oral at 50 mg twice daily, minoxidil (ROGAN, strength: 5%) topical apply 1 cap full every other day to affected area on scalp for alopecia, ondansetron (ZOFRAN, formulation: tablet, strength: 4 mg) oral at 4 mg as needed for nausea, pantoprazole sodium sesquihydrate (PROTONIX, formulation: tablet, strength: 40 mg) oral at 40 mg once a day, prednisone (DELTASONE, formulation: tablet, strength: 5 mg) oral at 5 mg daily (every morning), sertraline hydrochloride (ZOLOFT, formulation: tablet, strength: 100 mg) oral at 100 mg twice a day (every morning), sulfamethoxazole/trimethoprim (BACTRIM) 400-80 mg per tablet (1 tablet by mouth every Monday, Wednesday, Friday), tacrolimus (formulation: capsule) at 3 mg daily (2 mg every morning and 1 mg at night), salbutamol sulfate (PROVENTIL HFA) as needed for wheezing (shortness of breath), salbutamol sulfate (VENTOLIN HFA) as needed for wheezing (shortness of breath) , salbutamol sulfate (PROAIR HFA) as needed for wheezing (shortness of breath), ascorbic acid/ferrous fumarate/folic acid/ retinol (PRENATAL, formulation: tablet) oral daily. The patient previously took NSAIDs and voriconazole and experienced drug allergies. It was reported that the patient presented to emergency department (ED) on 04Feb2021 with chief complaint of worsening shortness of breath, nausea and diarrhea for past week since receiving since receiving COVID-19 vaccine. Full viral panel including COVID-19 was not detected. All blood cultures and respiratory cultures were negative. Patient chest x-ray shows numerous bilateral patchy opacities which is significantly different from her previous chest x-ray here. Empiric rejection treatment initiated including high dose methylprednisolone, plasmapheresis, IVIG, thymoglobulin. She continued to decline and ultimately required intubation, proning and paralyzing on 08Feb2021 and then VV ECMO cannulation on 13Feb2021. Acute pupil exam changes in the early am hours of 15Feb2021 prompted urgent head CT which revealed catastrophic brain bleed. Brainstem reflexes were lost soon after. Despite placing an EVD emergently at bedside, brain stem reflexes were not recovered. The events were all serious. The patient outcome of the events was fatal. The patient died on 15Feb2021. It was not reported if an autopsy was performed.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. However, the reported event may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Chest x-ray shows numerous bilateral patchy opacities; Catastrophic brain bleed; Brainstem reflexes were lost; shortness of breath; nausea; Diarrhea; Worsening shortness of breath/numerous bilateral patchy opacities

still have sore muscles in my shoulders; still feeling bad with all the above symtoms; 23Jan2021 went to get covid test but due to blood in my nose received antibody test which was neg; bad headache; winded; vomited; diaherra; coughing/cough; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; large clots gushed from my rt nostril went to er stopped bleeding after 2 hrs; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283, expiry date not reported), via an unspecified route of administration on the left arm on 20Jan2021 18:45 at single dose for COVID-19 immunization. Medical history included diabetes mellitus and high BP from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine, losartan potassium and sodium fluoride (CREST CAVITY PROTECTION). The patient previously took septra and experienced allergies. The patient reported that on 21Jan2021, they woke up and brushed their teeth then at 6:40am blood with large clots gushed from their right (rt) nostril. The patient went to ER and stopped bleeding after 2 hrs. On 22Jan2021, the patient woke up with bad headache, winded, vomited, diaherra (as reported), coughing. On 23Jan2021, they went to get covid test but due to blood in their nose, they received antibody test which was negative. On 24Jan2021, the patient was still feeling bad with all the above symptoms. Then on 25Jan2021, they went to ENT doctor who cauterized their nose and stated that since antibody was negative to take the maderna vaccine since they have no antibody in their system, the Pfizer vaccine did not work. From 26Jan2021 to 13Feb2021, the patient felt same started feeling better 14Feb2021 but still have sore muscles in their shoulders and cough. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 23Jan2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of epistaxis and clot blood which include the doctor cauterized their nose. The patient recovered with sequel from the events.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the epistaxis and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including CBC and coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

I had a stroke; This is a spontaneous report from a non-contactable Nurse. A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3302), via an unspecified route of administration in left arm on 02Feb2021 at single dose for Covid-19 immunisation in hospital. Medical history included hypothyroid. Patient is not pregnant. Concomitant medication included levothyroxine, trazodone, famotidine (PEPCID), cyanocobalamin (VITAMIN B 12). The patient previously took codeine and experienced drug hypersensitivity. Historical vaccination included BNT162B2(lot number:EL3248) on 12Jan2021, in left arm, first dose. No other vaccine in four weeks. No Covid prior vaccination. The patient stated I don't know if it was a result of the Covid shot. But I don't have any comorbidities and I had a stroke on to four which was two days after the shot on 04Feb2021 09:30 with outcome of recovering (as reported). AE result in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, hospitalization (2 days), disability or permanent damage. The patient underwent lab tests and procedures which included Nasal Swab, Covid test result: negative. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Despite insufficient clinical information provided, by close temporal relationship and absence of factors which may provide an alternative cause, the company deems there is a reasonable possibility that the reported stroke is related to the suspect drug Comirnaty. The impacts 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.

Fluid buildup in lungs. Than pneumonia set in.; Fluid buildup in lungs. Than pneumonia set in.; Weakness; lethargic; This is a spontaneous report from a contactable consumer. A 61-year-old female patient received BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) taken for an unspecified indication, start and stop date were not reported. The patient experienced fluid buildup in lungs. than pneumonia set in, weakness and lethargic on 15Feb2021. Therapeutic measures were taken as a result of all the events which includes Medicine and breathing treatments. Outcome of the events was recovering.

I am retired handicap-MS. I was doing light housework. I started getting pain in right lung, over course of 2 hours pain became very severe. Only in right lung. Felt like blood clot or pulmonary embolism (which I had 15 yrs ago). Went to hospital, check X-ray no clot/embolisms. Blood work showed no clotting factor. Was admitted 4 days. We treated possibility of MS reaction (solu-methyl) as well as heparin in event of unknown clotting issue. Here?s why this is strange: If this was MS flare/relapse, I would have muscle lockup, drop foot, sight issues, sever balance issues ...(i always have sight issues).. with this even it was only severe lung pain. Did not appear to be MS driven issue. Being educated ?high analytic person, in reflection, My ms is very territorial, it fights anesthesia, colds/flus/covid when my husband had it. My MS gets cranky when my immune system is attacked. I suspect the second covid injection was doing its thing, dna modification, and I had some lung inflammation and my MS compounded the reaction with crippling issue. I was in hospital 4 days, IV fluids, heparin, and steriod IV. Within first 36 hours the extreme lung pain disappeared and I got better. I do have cats scan, mri, X-rays from stay. Cat scan clear, X-ray, normal, mri-classic ms history. Was this Ms event? I?m not sold as I didn?t have other normal MS flare symptoms. Was this injection aggreviated? Perhaps... I?m sharing this because I think tracking auto immune disease people is important data gathering. Feel free to call if more dialogue is necessary

Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for Covid-19 vaccine, Dose #1. She developed itching in there throat within 30 minute waiting period. She was taken to Rapid Response Room. Symptoms progressed from itchy throat, to congestion in throat/upper chest, clearing her throat, watery eyes. Then dry cough. No nausea, no vomiting, no light headed feeling. No facial swelling No hives. OBJECTIVE: Vitals - 154/97, 105, 100%RA Neck - Supraclavicular mild retractions, end inspiratory stridor CV: tachy, regular, no murmur pulm - diminished breathe sounds throughout, no wheezing. Speaking full sentences. Assessment/ Plan: Anaphylaxis to Covid-19 Vaccine: - emergency responders - epi 0.3 mg IM administered to L mid outer thigh at 9:35 am by me - epi 0.3 mg IM administered to R mid outer thigh at 9:41 am because symptoms not subsiding by me -benadryl 50 mg IM x 1 L deltoid by RN 9:45 am - Itching in throat subsided but still retracting and clearing throat so albuterol 3 puffs given at 9:50 am Vitals stable entire time (see midas report) EMS arrived to transport to local hospital.

3 days after completing vaccine series, pt develop right leg pain and swelling, which progressed later on to shortness of breath after a week.

Severe itching all over, anaphylactic, took two allergy pills and medical test on music related to the nostril shot of Flonase

AFib; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in right arm, on 15Mar2021 at 14:00 (02:00 PM), at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. One week after the vaccine on 22Mar2021 at 09:00 AM, the patient had an atrial fibrillation (Afib) event. On 22Mar2021, the patient went to the emergency room (ER) or department or urgent care and ran tests including electrocardiogram (EKG), chest X-ray, and blood work which were all normal. Now, the patient had to go to a cardiologist for further understanding of the reason for AFib event. No treatment was given for the event. The patient has not been tested for COVID-19 post-vaccination. The patient was recovering from the event. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

I experienced a slight headache sore arm and elevated blood pressure after the shot. My blood pressure is usually very well controlled. On Monday the 29th, at about 3:30 pm, I started to slur my words. At first we blamed it on the Novocaiine earlier in the day, but I had been talking fine after it and had had it many, many times before and it was worn off. We called my doctor's office after my right arm and leg became very heavy and awkward. They told me to go to the nearest hospital. When I got there, I presented ass a full stroke. I was very hard to understand and my mouth drooped and I had very little use of my right arm and leg. They ran tests, but could not give me the medication because I was already on Eliquis. They thought they saw a small clot very high up. I was hospitalized over the next four days and improved my speech dramatically after a bad headache on March 30. The doctors go back and forth to whether it was a Acute Ischemic Stroke, which is what my paperwork says and a complex migraine. I do not experience migraines or anything like this ever before. I did not have a real headache on the 29th. Since my symptoms, right arm and leg difficulties are still here, my Doctor believes it was a stroke. I have an appointment with a Neurologist and I have to have another MRI. I am going to Physical Therapy. My Doctor told me to fill this out, she thinks it may be from the vaccine.

4/9/21-30 minutes to 1 hour after receiving 2nd dose of vaccine patient had bloody nose, clots, with bleeding sores on tongue and side of mouth. Began to have bruises on arms, feet and legs. Blood in urine and bruises on back. Presented to emergency department on 4/11/21. CT brain revealed a right sided posterior temporal hemorrhage. Patient was emergently treated with platelets, DDAVP, factor VII, Decadron, IVIG. 4/12/21, patient denies headache, changes in vision, double vision, change in sensation, including burning, pinprick, numbness, no focal or motor weakness. No change in bowel or bladder control. No sensory changes. Patient states she is now back to her normal state of health, save for the bruising described.

anaphylaxis/anaphylactic condition; abnormal heart problems; vocal cord dyskinesia; SOB; extremely red all over body; Abnormal liver enzymes; Hr became Brady with widening if qtinterval; leg cramps; neuro s/s migraine severe; throat closed; Weight gain 15+ lbs on body non pitting edema; non pitting edema; extreme leg pain; breathing problems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 via an unspecified route of administration in right arm on 27Mar2021 16:45 (Lot Number: er8733, expiration date was unknown) as single dose for covid-19 immunisation. Medical history included asthma, brain disorder, arthritis, vertigo. Patient had known allergies. It was unknown if patient had COVID prior vaccination. She was not pregnant at the time of vaccination. Patient did not have other vaccine in four weeks. She used other medications in two weeks. The patient experienced anaphylaxis within 5 minutes went home extreme leg pain. Her throat closed and she had short of breath (SOB). She had extremely red all over body. She went back to emergency department (ED). Electrocardiogram (EKG), X-ray and blood work were done. She had c/o leg cramps. Her weight gain more than 15 lbs on body with non-pitting edema. She received treatment for events. She had abnormal liver enzymes, abnormal heart problems and breathing problems. Anaphylactic condition was to step down was on bipap epi (Epinephrine injection) Benadryl 50 mg every 4 hours and intravenous steroids along with fluids. Renal replacement therapy (RRT) called the next day. Patient didn't remember exact cause. Neuro s/s migraine severe Ajovy taken Uberlvy and not else remembered (as reported). Heart issues maintained and pulmonary showed improvement. Ear, nose, and throat (ENT) consult with scope done showing vocal cord dyskinesia. Heart rate became brady with widening if qt interval. She transferred to telemetry 2 d and echo done. Monitor patient for low heart rate 24 hours. Patient released from hospital on 06Apr2021 evening. At home patient continue to have organs change every 24- 36 hours keeping video monitoring and pictures. All events occurred on 27Mar2021 16:45 and resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization/Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The duration of hospitalization was 6 days. Patient tested COVID-19 via nasal swab on 01Apr2021 with negative result. Benadryl 50 mg she had around the clock, steroids and epi used as treatment. The outcome of all events was not recovered. No follow up attempts are possible. No further information is expected.

having a stroke; I began to experience numbness on my entire left side, left arm; hand weakness, left leg weakness; trouble walking/stumbling; speech problems; slurred speech; fatigue; injection site pain; nausea; pain in my left hip; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8727), via an unspecified route of administration, administered in left arm on 29Mar2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included chronic fatigue syndrome, fibromyalgia, sulfa allergy. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient experienced immediate fatigue, injection site pain, nausea, along with pain in her left hip the day after her first Covid vaccine on 30Mar2021 05:00 (Tuesday). The injection site pain resolved after a few days, but she continued to be exhausted and nauseous all week. On 02Apr2021 (Friday), she began to experience numbness on my entire left side, left arm and hand weakness, left leg weakness, trouble walking, speech problems, having to really think about her words (her daughter-in-law was typing this as she could not), slurred speech, stumbling. Her family was concerned she was having a stroke on 02Apr2021 05:00, but have no drooping in her face. She was so scared that she will not be getting her second vaccine. She have not gone to a doctor, as she do not have insurance. The symptoms were continuing. No treatment was received for the adverse events. The outcome of the event 'injection site pain' was recovered; the events fatigue and nausea was not recovered; and unknown for the rest of the events. Events were reported as non-serious. Information on lot/batch number was available. Additional information has been requested.

Severe left chest back and shoulder pain lasting more than 2 days; Severe left chest back and shoulder pain lasting more than 2 days; Severe left chest back and shoulder pain lasting more than 2 days; high BP; fluid around heart; elevated D DIM; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer BioNTech, lot: EN6199) in left arm on 06Apr2021 06:30 PM at a single dose for COVID-19 immunization. Facility type vaccine was Pharmacy or Drug Store. Medical history was not reported. Patient was not pregnant (AS REPORTED) at the time of vaccination. Concomitant medications were unspecified. No other vaccine in four weeks. Other medications in two weeks was yes. Patient used to receive Wellbutrin and experienced allergies. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: ER8733) in left arm on 17Mar2021 05:00 PM at a single dose for COVID-19 immunization. Patient experienced severe left chest back and shoulder pain lasting more than 2 days accompanied by high blood pressure (BP), fluid around heart and elevated D DIM on 07Apr2021 05:30 AM. Adverse events (AE) resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). The outcome of the events was recovering. AE treatment: Ultrasound, CT Scan, morphine. If COVID prior vaccination was no. If COVID tested post vaccination was no.

Six days after my 2nd vaccine I had an anaphylaxis reaction. Out of the blue while I was driving my face started to burn like acid was rubbed on it. It got really hot and turned very bright red. Then my lips began to feel like they had been sunburned badly. Then my forearms both started burning and also turned bright red. I was very anxious. Had two bouts of diarrhea. All this occurred within about a 20 minute time-frame. I chewed up 4 children's Benadryl (50mg) and the redness, burning and anxiousness subsided mostly. My heart rat was still over 100 bpm even after 6 hours. (Usually my HR is 68-70 bpm). I slept for 12 hours and the next day seemed fine. This has occurred two more times since that first time. The 2nd reaction being 5 days after that first one and the 3rd reaction being 5 days after that. Same reaction, same treatment and same outcome.

Anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness; Anaphylaxis-swelling of eyes, tongue, and injection site.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unspecified), via an unspecified route of administration, administered in right arm on 05Apr2021 16:00 as single dose for COVID-19 immunization. Medical history included known allergies: yes and hypertension. The patient was not pregnant. Concomitant medications included metoprolol succinate (TOPROL XL), lisinopril dihydrate (LISINOPRIL), and cetirizine hydrochloride (ZYRTEC). The patient had no other vaccine in 4 weeks. On 05Apr2021 16:15, the patient experienced anaphylaxis-swelling of eyes, tongue, and injection site, rash/hives, shortness of breath, and dizziness. The events resulted in emergency room/ department or urgent care. Therapy for the events included prednisone, antihistamine, and intravenous (IV) fluid. The patient did not have covid prior vaccination and was not Covid tested post vaccination. Outcome of events was recovering. Information about lot/batch number has been requested.

she could have partially had a stroke; She woke up and her left hand and arm were numb; left arm hurts a couple of days ago; Her hand is now cramped up, and she cannot bend it, almost like someone who has cerebral palsy.; she could not use her left hand; Her hand is now cramped up, and she can not bend it, almost like someone who has cerebral palsy./all her fingers are cramped and she cant open them and her hand is in a brace; radial nerve palsy; This is a spontaneous report from a contactable consumer or other non hcp. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6198) via an unspecified route of administration, administration in left arm on 19Mar2021 as SINGLE DOSE for covid-19 immunization. Medical history was not reported. There were no concomitant medications. On 01Apr2021, she woke up and her left hand and arm were numb. She went to the hospital, and they told her she could have partially and had a stroke. Three days after receiving the first dose of the Covid vaccine, she could not use her left hand. Her hand was now cramped up, and she could not bend it, almost like someone who had cerebral palsy. She stated that after the first dose her left hand went numb, and she went to the hospital and was diagnosed with radial nerve palsy. She stated that all her fingers are cramped, and she can't open them, and her hand was in a brace. She stated that she would have to do physical therapy. It was her left hand, the same arm that she got the first dose of the Covid vaccine in. She could not move her left hand. She was really annoyed about it, and she was scared. The patient stated that she had a grandson and a daughter. This vaccine was the best possible way to prevent Covid. She had always got vaccines. Upon follow-up received on 09Apr2021, she was calling about the Pfizer Covid vaccine. She does not have a ride to get her second dose of the Covid vaccine on Saturday morning. She does not know the name of the facility where she was supposed to go. She was asking for help with an (cab service). She thought she was calling her county. She would call her county and ask for help with a ride. She had a reaction after her first dose of the Covid vaccine. She received the first dose on 19Mar2021. She does not know if it was because of the Covid vaccine. She was asking if she should get the second dose of the Covid vaccine in the same arm as last time. She wanted to get the second dose of the Covid vaccine in the same arm as last time, so that she does not mess up the other side of her body. She was asking what was going on with her arm. She was asking if thaws had anything to do with the Covid vaccine. Upon follow-up received on 09Apr2021, she scheduled second dose due on 10Apr. Her left arm hurts a couple of days ago, it ended her going to the hospital. She called to ask if it had something to do with the Covid vaccine. The event hypoaesthesia, cerebral palsy, muscular weakness, muscle spasms outcome was reported as not recovered. The event cerebrovascular accident, pain in extremity, radial nerve palsy outcome was reported as Unknown. The action taken in response to the events for bnt162b2 was not applicable. Therapeutic measures were taken as a result of her hand was now cramped up, and she cannot bend it, almost like someone who had cerebral palsy. (cerebral palsy). Follow-up (09Apr2021): This follow-up spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: New significant information.

Client received vaccine Wednesday morning. Client started to feel weak the next afternoon. Got out of vehicle and almost fell due to leg weakness and had an abnormal gate. After 20 minutes had passed, symptoms got better. A couple hours later that day it happened again, but this time with arm weakness and hand fell at side. Client then went to ER. Had CT scan and MRI which showed client had a small clot causing a small stroke. Client had no risk factors for a stroke. Not a smoker, no high blood pressure, and good cholesterol. Doctors were unaware if the stroke was correlated with vaccine or not. Primary care physician is running labs to see if there is a clotting disorder.

I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.

thrombocytopenia; Heavy blood in the stool; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of BNT162B2 (Lot Number: EN6148), via an unspecified route of administration in arm left on 21Mar2021 as single dose for COVID-19 immunisation. Medical history was none. No known allergies. The pateint was not pregnant. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 28Feb2021 for COVID-19 immunisation. No other vaccine in four weeks. No ther medications in two weeks. The patient experienced Heavy blood in the stool, thrombocytopenia on 07Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. No treatment received. No covid prior vaccination. No covid tested post vaccination. No covid tested post vaccination. The outcome of events was not recovered.

Anaphylaxis- patient unconscious briefly prior to receiving Epinephrine. After injection, patient slightly arousable- transferred to ED via EMS.

Blood clots in colon; 2nd dose 07Jan2021; This is a spontaneous report from a contactable other hcp (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19), second dose at the age of 61-years-old via an unspecified route of administration, administered in arm left on 07Jan2021 (Batch/Lot Number: Ek5730) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient has no known allergies. Concomitant medication included unspecified medication. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in the left arm on 22Dec2020 (lot number: Ek5730) at the age of 61-years-old for covid-19 immunisation. The patient experienced blood clots in colon on 14Jan2021. It was noted that the patient received the second dose on 07Jan2021. The patient was hospitalized for blood clots in colon for 30 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Jan2021. Therapeutic measures were taken as a result of blood clots in colon which included surgery. The patient was recovering from the event.; Sender's Comments: Based on event-vaccine chronological association a causal relationship between event blood clots in colon and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), cannot be completely excluded. . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

1/20/2021 - pt experiencing marked fatigue 01/23/2021 - pt went to ED with fatigue, sweats, cough, and low BP. Admitted with diagnoses of cardiogenic shock, myocarditis, acute renal failure, heart failure, anemia, UTI, oral thrush. Treated with IV fluids, dialysis, temporary pacemaker. 02/06/2021 - discharged to rehab facility 02/17/2021 - discharged home

reported to ER with 1 day history of change in status of left arm weakness/imbalance with walking. Within 1 day symptoms were improving by time of presentation to ER. Ultimately was admitted and found to have an area of 1 to 2cm area of acute infarction in right posterior frontal lobe found on MRI after initial CT scan and other labs were normal.

62F with stage 2 mycoises fungoides, peripheral neuropathy, HTN, HLD, admitted from hepatology clinic on 3/25/21 for worsening liver injury and URI symptoms, found to be COVID positive. Liver biopsy with evidence of severe hepatitis with bridging necrosis. Course complicated by increase encephalopathy 3/31/21 concerning for acute liver failure, requiring stay in COVID ICU, transferred to hepatology service on 4/2/21. DDx remains viral hepatitis, autoimmune hepatitis, and drug-induced liver injury now on steroid therapy as of 3/31/21 and NAC. Pt. had worsening ALF and encephalopathy, transitioned to comfort care. Pt died early morning of 4/4/21

Pt presented to ED w/N/V, coughing, headache, fevers, fatigue x 1 week and inability to keep PO intake down. Started developing symptoms on 4/16, tested negative for COVID on 4/19. Was found to be COVID positive despite getting Pfizer vaccines (3/11/21 & 4/1/2021). Was admitted for additional management of acute hypoxic respiratory failure due to COVID-19 pneumonia and N/V/D with electrolyte imbalances. Treated w/remdesivir and dexamethasone. Her N/V and electrolyte imbalances improved w/IVFs and zofran. Was discharged on 4/28 w/follow-up in 5-7 days.

May 1, 2021, Patient was admitted to the hospital with Blood clots in both lungs. The hospital is unable to figure out what has caused the blood clots. We do not know if this is related to the vaccine but would like to know if it is.

Muliple segmental and subsegmental low risk pulmonary embolisms presenting with dyspnea and hypoxia. Succesfully treated and patient on treatment with a DOAC

Patient developed paroxysmal atrial fibrillation. Upon date of death- pt husband reported SOB, incontinence, gasping for air, slumped forward and died upon 911 arrival.

61 Year old female presented with shortness of breath and was found to have a platelet count of 11 k/ul ( She had a platelet count of 184 k/ul 12 days prior). She received 2nd dose of Pfizer vaccine 21 days prior to the event. She received steroids with improvement in platelet count.A diagnosis of immune thrombocytopenia ( non thrombotic) was made.

ED Note: "presents to the ED via RRT from pre-op after having a left SI injection with complaints of a stroke alert. at 1132 this morning. Per NP from pre-op, the pt received the injection without issue. After the injection she was developed groin numbness, which progressed into a headache, and chest pain. She then became aphasic, with left sided weakness and numbness. BS was 154 at that time. Per husband at bedside, the pt had numbness and tingling after injection but was otherwise at baseline. While the pt was getting dressed, the husband went to get the car. He notes the pt is on Xarelto secondary to PE and has taken it as prescribed. He denies any missed doses but states he is unsure of what time the last dose was. He states that the pt has no lasting deficits from her prior stroke. Of note, the pt is able to respond by nodding yes or no but is unable to speak. Pt able to write on a white board. She states she was taken off the Xarelto 3 months ago. The pt states she is unable to talk. She endorses left arm and leg weakness. The pt states she has a prior stoke years ago with weakness but has no lasting deficits. " Admitted to the hospital Diagnoses: -Dysphasia -Small vessel cerebrovascular disease -Bereavement -Vitamin-D deficiency

Numerous blood clots in both lungs; This is a spontaneous report from a contactable consumer (patient reported for herself). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8730, expiry date not reported), via an unspecified route of administration, administered in left arm on 09Apr2021 09:00 AM as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included degenerative disc disease, fibromyalgia, hypothyroidism, migraines, known allergies to tape and anise allergy. The patient had negative nasal swab on 07Nov2020. The patient had no covid prior to vaccination. Concomitant medications included morphine at 15 mg, twice a day; oxycodone (XTAMPZA ER) at 36 mg; and heparin; all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2 as COVID-19 immunization on 19Mar2021 09:00 AM (at the age of 61 years old) (brand Pfizer, lot en6208) administered on the left arm. The patient had no other vaccine in four weeks. On 30Apr2021 09:00 AM, patient had numerous blood clots in both lungs. On 01May2021 to May2021, she was admitted to the hospital for 2 days with numerous blood clots in both lungs. After several tests (May2021), they could not find any reason for getting these clots. So, thinking the only other thing patient did different was get the covid vaccine. The event was reported as serious medically significant, life threatening, and had caused hospitalization from 01May2021 to an unspecified date in May2021. It resulted to emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of the event which included Heparin IV. The patient had not recovered from the event numerous blood clots in both lungs.

Second blood clot that traveled to her brain which caused her to have a stroke; Blood clot in her right leg; Weight Loss from 258 pounds, down to 208 pounds, back up to 214 pounds.; She has to learn how to walk again, she is in a wheelchair now; Having Problems Swallowing from the Stoke; Speech went down to 25% and now she is at 50%, because of the Stroke; high blood pressure; slept five days; Arm was Sore; Body was Sore; Diarrhea; Slept and was Totally Exhausted; This is a spontaneous report received from a contactable consumer (husband of the patient) and a contactable other healthcare professional. This consumer reported similar events with different doses of the same product; this case refers to dose 2; only this case is serious. A 61-year-old adult female received the second dose of BNT162B2 (solution for injection, Lot EL3246 expiry information not provided) as a single dose via an unspecified route on 30Jan2021 at 13:45 (at 61-years-old) for COVID-19 immunization. Relevant medical history included ongoing seizures (1964; began at 5 years old, minor seizures; under control in 1984, possibility configuration it is the right cocktail), and wound on her left leg (that was being treated by a wound doctor for the last 7 years). Concomitant medications included gabapentin; 300mg three times a day by mouth (6am, 2pm and bedtime) ongoing from 2014 for nerves; valproate semisodium (DIVALPROEX; 500mg two tablets in the morning and one tablet at 6pm ongoing from 2010 for seizures furosemide 20mg every 48 hours (odd days); States she takes it to reduce swelling (diuresis)on the leg wound leg; states he gives it to her on the odd day of the month from an unspecified date; metoprolol (50mg) one tablet twice a day (6am and 6pm), for Blood pressure management; ascorbic acid, zinc (VITAMIN C WITH ZINC; 500mg/50mg) once daily from an unspecified date for an unspecified indication; acetylsalicylic acid (ASPIRIN) 81mg once daily from an unspecified date for an unspecified indication; and pramipexole 0.5mg once daily at 6pm ongoing from an unspecified date for seizures. The patient previously received COVID-19 immunization with the first dose of BNT162B2 (solution for injection; Lot EL1284) on 09Jan2021 (at 61-years-old) and experienced arm was sore, slept for two to three-days, body was sore, and diarrhea. The consumer reported that on 30Jan2021, the patient experienced her arm was sore, her whole body was sore for about five days, she had diarrhea for five days, and she for slept five days and was totally exhausted. The consumer then reported that on 22Feb2021, she developed a blood clot in her right leg. The reporter explained that her leg swelled up and turned dark blue, almost black. The consumer reported that the patient was immediately rushed to the hospital. Caller states they did all sorts of tests and confirmed she had a blood clot in her right leg. States she was hospitalized from 22Feb2021 through 26Feb2021, so for five days. Caller states the leg went back to normal color, the swelling went down and she felt good. Caller states they came home on 26Feb2021, and she was up moving around, and everything was wonderful. On an unspecified date in Feb2021, around the time of the first blood clot, the patient was diagnosed with high blood pressure. Caller states on 12Mar2021 she had a second blood clot that traveled to her brain which caused her to have a stroke. Caller states when they got to the hospital they said she had a stroke from a blood clot that was somewhere in her system and it traveled to her brain. Caller states she was hospitalized from 12Mar2021 through 16Mar2021 when she was released from the hospital. Caller states she was too sick to go home so she was transferred to Rehab Center. She was there from 16Mar2021-27Apr2021. Caller states on 27Apr2021, she was transferred for rehab. Caller states at the center they only give rehab once a day for 30 minutes and he only works five days a week. Now she gets three hours of physical therapy a day and it is seven days a week. States they are working to get her to walk again and she is receiving speech therapy. States she has to learn how to walk again. Caller states her lowest weight was 208lbs, and they weighed her in yesterday and she was at 214lbs. Caller states with the stroke when she was at the hospital, they put her on baby food because she was having problems swallowing. While at rehab center she went from baby food to mechanical food. On 27Apr2021 she went to regular food. Speech because of the stroke went down to 25% and now she is at 50% and she is also getting one hour of speech therapy at hospital. Caller states they recognized it is important to get as much therapy as possible in the first 90 days, they call it a boot camp and patients are limited to 90 days to repair the damage. After 90 days, that is it. States that is why it was important to transfer her to hospital to heal and get back to normal. Caller states she is in a wheelchair and they are trying to get her to stand up. Caller states at the hospital they were able to get her to take 2 steps. At Hospital they were able to get her to do special training and he was able to get her to take 4 steps. Caller states he has no idea where she is with the walking right now. States she did not do anything on the 27Apr2021, because that was arrival date. Therapy started yesterday on 28Apr2021 at Hospital. The consumer also reported that the patient's current weight is 214 pounds, from 258 when she took the shot and down to 208 pounds on an unspecified date in 2021. Treatment for the events included occupational, physical and speech therapies, as well as apixaban (ELIQUIS), rivaroxaban (XARELTO), and spironolactone 25mg once a day; takes in the evening at 6:00p.m. ongoing from 12Mar2021 for hypertension. The outcome of the events arm was sore, body was sore, diarrhea, and slept and was totally exhausted and slept five days was recovered on 04Feb2021. The outcome of the event blood clot in right leg was recovered on 26Feb2021. The outcome of the event second blood clot that traveled to her brain which caused her to have a stroke was recovered with sequelae on an unspecified date in 2021. The outcome of the event Having Problems Swallowing from the Stoke was recovered on 27Apr2021. The outcome of the events speech went down to 25%, back up to 50%, and weight loss from 258 pounds, down to 208 pounds, back up to 214 pounds was recovering. The outcome of the event high blood pressure was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021484454 PFIZER (Same reporter/patient/different doses/events)

2/22/21 Had Nuc scan to eval for blood clots/ there was no evidence 5/12/21 ct scan finds PE post vaccine. in with cough and SOB

TIA/Mini stroke; Blood pressure went up to 240/130; Loss of memory; Everything is foggy; Lips and tongue started tingling; Stinging lips; She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 21Mar2021 10:30 (at the age of 61 years old), 1st dose, single for COVID-19 immunization. Medical history included diabetes and ankle problem from an unknown date and unknown if ongoing, and bariatric sleeve from 2018 to an unknown date. Concomitant medications included all her normal medications and medications for high blood pressure (not specified). The patient reported that she was administered with the first dose of the vaccine on 21Mar2021 and on the same day, her lips and tongue started tingling during the observation period after the administration. The patient also reported a few days later on 02Apr2021 that she had a transient ischemic attack (TIA), which was also described as mini stroke. The patient also reported that she has not been administered the 2nd dose. She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose. She also complained since day one on 21Mar2021 about the stinging lips and tingling tongue. She was hospitalized with the mini stroke, she was admitted 02Apr2021 and discharged 04Apr2021. Another thing was loss of memory on 02Apr2021, from the time the ambulance picked her up and took her to the local hospital she recalls that, but she doesn't recall that hospital to being transferred 6-7 hours later. She stated she doesn't recall anything, it's like a blank. She was transferred from one hospital to another and the 1st hospital she recalled getting there, her mom worked there, but she doesn't recall the 6 hours in between or the ambulance ride to a different town. She stated everything is foggy. She still has problems remembering, it's better but she still has problems remembering like if she is talking to somebody and gets sidetracked, she doesn't recall what she was saying. The patient reported that her blood pressure went up to 240/130 on 02Apr2021 when the ambulance picked her up. She reported that since 2018 her blood pressure was always normal until after the vaccination. The patient underwent a heart monitor, brain scan EEG, an MRI and echocardiogram/EKG on an unknown date, with unknown results. The outcome of the events "Stinging lips" and "Lips and tongue started tingling" was recovered on 02Apr2021, and unknown outcome for other events.

BNP just went up and up; Congestive heart failure; She couldn't walk up the stairs; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 02Feb2021 (Lot Number: EL8982) as SINGLE DOSE for covid-19 immunisation, in the afternoon around 4 or 5 o'clock. Vaccination Facility Type was Nursing home/Rehabilitation Center. Medical history included psoriasis from 1986 and ongoing; stent in 2016, the doctor was sure the heart failure was not related to her stent; swollen leg from Jun2020 to an unknown date. She went to her Cardiologist, they said she has no heart failure. The Cardiologist told her the fluid from her knee drained down into her ankle that was why it was swollen, her BNP indicator was 165 at the doctor then. Concomitant medications included atorvastatin (LIPITOR) taken for cholesterol, coronary artery disease, cardiac disorder from 2016 and ongoing; clopidogrel bisulfate (PLAVIX) taken for blood viscosity decreased from 2016 to 14Apr2021, patient reported when she went to the hospital they checked for a PE or Pulmonary Embolism or blood clot, they found nothing, the cardiologist said her blood was flowing beautifully so he discontinued the Plavix; acetylsalicylic acid (BABY ASPIRIN) taken for blood thinner from 2016 and ongoing; ezetimibe (ZETIA) taken for blood thinner, start and stop date were not reported. The patient previously took the first dose of bnt162b2 on 11Jan2021 (lot number: EL0142), also at age of 61 years old, at left deltoid for covid-19 immunization; tremfya injection 100 mg every 60 days for psoriasis. The patient experienced congestive heart failure (CHF) (hospitalization, disability, medically significant) in Feb2021 with outcome of not recovered, she couldn't walk up the stairs (hospitalization) in 2021 with outcome of unknown, bnp just went up and up (hospitalization) in Apr2021 with outcome of unknown. The patient was hospitalized for events from Apr2021 to 16Apr2021. Patient report she got short of breath, which she didn't attribute heart failure, she thought it was something with her lungs. And had a cough. She reported she was so short of breath she couldn't walk up the stairs. At the beginning of the month, she was better, but she couldn't go up the stairs, and she was taking cough syrup and things which didn't help. Then she was in the emergency room either on 13Apr2021 or 14Apr2021 and then she was admitted to the hospital, and then she had CHF. This started 2-3 weeks after getting the 2nd vaccine the shortness of breath, heart congestion and wheezing. Her husband said she needs to go pulmonologist to be seen. Patient confirmed she went into the hospital on the 13Apr2021 but, it was midnight and it could have been the next day also, it varies, the time. The shortness of breath and things started in February or March started, they started slowly. She could not breath at all, it started around 2-3 weeks after the vaccine. It was so bad she could not walk around, her husband was worried he went to get the car and she waited on a bench. She could not breath. These things started before 16Mar2021, maybe, between the 15Feb2021 to 21Feb2021. Patient said CHF was heart didn't pump sufficiently anymore. She was now on disability and has a Life-Vest. She was on tons of medications. She wears Life Vest for 3 months then will get echocardiogram or MRI to see what is going on. When she went to the hospital for the CHF, her BNP was 2700 and then it went to 3500. They gave her IV diuretics in the hospital but her BNP just went up and up. This was all on the same day she went to the ER, she spent 13 hours in the emergency room. They drew labs and cardiologics then. Patient got IV diuretics in the hospital, she believed it was Lasix or Furosemide. When she was discharged for the hospital at night on the 16th, her BNP was 518, so they let her go because the diuretics worked. The diuretic was change to oral Torsemide at her discharge. Investigations included chemistry, BNP, a blood count, a metabolic panel.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, Cardiac failure congestive, gait disturbance, brain natriuretic peptide increased cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate.

Patient presents to the ED with shortness of breath, chest pains and palpitations. Has noticed rapid heart rates for last 2 months, started immunotherapy. Started on diltiazem and symptoms resolved. Diagnosed with Afib and COPD exacerbation. Recently diagnosed with left lung squamous cell carcinoma. patient will start on eliquis, digoxin and diltiazem. Discharged with symptoms resolved.

she experienced pain in her right leg and had DVT; she experienced pain in her right leg and had DVT; This is a spontaneous report from a Pfizer sponsored program.. A 61-year-old contactable female consumer (patient) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 05Apr2021 (at 61years old) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The second dose is scheduled on 26Apr2021 (correct dosing schedule). Patient missed her second dose because she had 2 ultrasounds after her first dose. In addition, she experienced pain in her right leg and had DVT on unspecified dates. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

As of 6/1/2021, pt presented with 3 weeks progressively worsening dyspnea on exertion and associated lower extremity pitting edema up to hips and was found to have acute bilateral pulmonary emboli, including a large thrombus seen in the left main pulmonary artery. Also admitted to nausea, orthopnea, PND, chronic leg swelling no worse than usual, and a productive cough with creamy white sputum.

Reaction began within a few hours of vaccination. Patient had fever, chills and diarrhea within a few hours of receiving the vaccine. By 4:30am on 3/31 she could not walk and her legs went numb. An ambulance was called and the EMTs had to carry her out of the house. She was taken to Hospital where they started treating her for an infection but her fever went up over 103F so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms. Doctors diagnosed sepsis. They continued to do blood test and cultures but could not determine the cause. They did MRIs as follow-ups because she was not responding. The fever never went down. She was awake for a few days (ventilator still in) and then started getting worse again. This is about 1.5 weeks post vaccination. They did an MRI and found a bleed on her brain and the infection had spread to her heart valves. Symptoms began within hours of vaccination. She was take to the hospital the morning after the vaccine and never came home. Patient died after 2 weeks in the ICU.

Patient presented to Medical Center on 5/5/21 with new onset right lower lobe segmental and subsegmental pulmonary embolism, received 2nd dose of Pfizer vaccine 4/15/21 per patient's ID physician, Dr.. Unknown LOT and location of Pfizer vaccination. Patient also positive for cocaine on admission and has chronic mycobacterium infection. PE possibly related to vaccination but has alternative explanations.

bleed on her brain; the infection had spread to her heart valves; she could not walk; legs went numb; sepsis; fever / fever went up over 103 F; chills; diarrhea; This is a spontaneous report received from a contactable consumer. A 61 years old female received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EP7533) on 30Mar2021 (at 61 years of age), in right arm, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on 09Mar2021 (lot EN6202), at 61 years of age, in right arm. No other vaccines were given within 4 weeks prior to the COVID vaccine. Medical history included connective tissue disorder - scleroderma. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included methotrexate. On 30Mar2021, within a few hours of receiving the second vaccination, she had fever, chills and diarrhea. By 4:30 AM on 31Mar2021 she could not walk and her legs went numb. An ambulance was called and the EMTs had to carry her out of the house. She was taken to hospital where they started treating with antibiotics her for an infection but her fever went up over 103 F, so they ventilated her to try to control the fever. They did blood tests during that time and got the infections disease unit trying to figure out what was causing her symptoms. Doctors diagnosed sepsis. They continued to do blood test and cultures but could not determine the cause. They did Magnetic Resonance Imaging (MRIs) as follow-ups because she was not responding. The fever never went down. She was awake for a few days (ventilator still in) and then started getting worse again. They did an MRI and found a bleed on her brain and the infection had spread to her heart valves. She died on 14Apr2021 after 15 days of hospital care and Intensive Care Unit (ICU) care. The events were reported with a fatal outcome. It was unknown if autopsy was performed. Since the vaccination, the patient had not been tested for COVID-19.; Reported Cause(s) of Death: chills; diarrhea; she could not walk; legs went numb; sepsis; bleed on her brain; the infection had spread to her heart valves; fever / fever went up over 103 F

She is worried it is a kind of blood clot.; She is worried it is a kind of blood clot.; Swollen lymph nodes in right leg; This is a spontaneous report from a contactable consumer(Patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 23May2021 as 2nd DOSE, Single for covid-19 immunization. Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities, obesity. No family medical history reported. The patient's concomitant medications were not reported. Patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm left on 02May2021 as single dose for covid-19 immunization. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. It was reported that, on 26May2021, after getting the second dose of the Covid vaccine, she had swollen lymph nodes in her right leg. She was worried and asks what to do and She asked if she needs to go to Urgent Care. she is worried it is a kind of blood clot. She asks if Pfizer will call her doctor and then call her. All she had were swollen lymph nodes. They are getting big and big. She confirms they are getting bigger. No relevant tests reported. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Component Results: Component Your Value Standard Range Flag; Troponin T, 2 hr., 5th gen 1923 ng/L<=10 ng/L<=10 ng/L H; Consider acute myocardial injury 2H Delta 862 ng/L ng/Lng/L;2H Delta Interp Changing Evaluate for acute myocardial injury; Troponin T, 6 hr., 5th gen; 2104 ng/L; <=10 ng/L<=10 ng/L H; Consider acute myocardial injury; 6H Delta SEE COMMENT ng/L ng/Lng/L; Test cancelled. Specimen not received within delta timeframe.; 6H Delta Interp SEE COMMENT; Test cancelled. Specimen not received within delta timeframe. General Information-Ordered by, M.D., Ph.D._____________________________________________________ Your Admission - 03/30/21Printer friendly page--New window will open-Admission Summary-Notes-Clinical Notes H&P by M.D., Ph.D. at 3/30/2021 3:55 AM-Status: Signed-CARD 3 Admission Note-SUBJECTIVE- CHIEF COMPLAINT= Chest pain. HISTORY OF PRESENT ILLNESS Patient is a 56 y.o. female who presented to the Emergency Department due to chest pain. She has experienced this pain each evening for the past 3 evenings, and states that it starts in her right arm then migrates through her shoulder and across to her chest. The pain can last for anywhere from 5 minutes to 4 hours. This has come on at rest, but in the setting increased personal life stressors as well as uncontrolled hypertension. She states that she is normally on hydrochlorothiazide for hypertension, but ran out of this medication about a week ago. When she checked her blood pressure at home it was in the 230s/120s, therefore she presented to the emergency department locally. Her medical comorbidities are notable for poorly controlled hypertension, mixed hyperlipidemia that is untreated, current tobacco use (1-2 packs per day for 40 years), and medically complicated obesity. In the emergency department she was found to have mild polycythemia with hemoglobin of 15.2 and leukocytosis of 13.7. INR, D-dimer, and BMP were normal. High sensitivity troponin T was found to be 770 ng/L. ECG showed normal sinus rhythm with T-wave inversion in aVL that was not present on 08/25/2004. Chest x-ray was largely unremarkable. Her chest pain resolved, but given the elevated troponin ECG changes she was treated for NSTEMI with heparin infusion, and loaded with aspirin and clopidogrel and directly admitted to the Hospital Cardiology service. Upon arrival she remained free of chest pain but continued to have significant hypertension. I have reviewed and updated the following: Past Medical History, Family History, Social History, and Allergies. Current Outpatient Medications on File Prior to Encounter: hydrochlorothiazide (HYDRODIURIL) 25 mg tablet, Take 1 tablet (25 mg total) by mouth daily., Past Week at Unknown time; Lorazepam (ATIVAN) 0.5 mg tablet, Take 0.5 mg by mouth daily as needed for anxiety., More than a month at Unknown time. REVIEW OF SYSTEMS Pertinent items are noted in HPI; all other review of systems was negative. OBJECTIVE VITAL SIGNS Temperature: [36.8 °C-36.9 °C] 36.9 °C; Heart Rate: [83-117] 83; Resp Rate: [20-26] 22; Blood Pressure: (164-195)/(81-129) 164/106; SpO2:[92 %-97 %] 95 %;Weight: [104 kg-106 kg] 104 kg; Pulse Rate: [90-109] 94. PHYSICAL EXAM General: Alert, oriented, no acute distress; HEENT: Mucous membranes moist, JVP difficult to assess due to body habitus; CV: Regular rate and rhythm without murmur; Lungs: Clear to auscultation bilaterally; Abdomen: Obese, soft, nontender, nondistended, normoactive bowel sounds; Extremities: No peripheral edema appreciated; Neuro: No focal deficits appreciated. DIAGNOSTICS I have reviewed labs and imaging from the past 24 hours. ASSESSMENT / PLAN Patient is a 56 y.o. female who was directly admitted to the Cardiology Service from Emergency Department due to NSTEMI and poorly controlled hypertension. She also has untreated mixed hyperlipidemia and is a current smoker. We will continue to trend troponins and treat NSTEMI was heparin infusion, aspirin, and clopidogrel. I will start a statin and initiate low-dose lisinopril and carvedilol for blood pressure control with plans to up titrate as tolerated. I will update a lipid panel in checked for diabetes. I will obtain a TTE in the morning and keep her NPO for probable coronary angiogram pending negative COVID swab. #1 Non-ST Elevation Myocardial Infarction; #2 Poorly controlled systemic hypertension; #3 Mixed hyperlipidemia, previously untreated; #4 Medically complicated obesity (BMI 38-trend troponin- loaded with aspirin and clopidogrel- Aspirin 81 mg daily- clopidogrel 75 mg daily- moderate intensity heparin infusion- rosuvastatin 20 mg daily- lisinopril 2.5 mg daily, up titrate as tolerated- carvedilol 6.25 mg twice daily, up titrate as tolerated- holding home hydrochlorothiazide in lieu of lisinopril and carvedilol- lipid panel - hemoglobin A1c- TTE- NPO for probable angiogram (not-ordered)- cardiac rehab consult ordered;#5 Abuse Tobacco Smoking- nicotine patch- nicotine inhaler as needed- nicotine cessation consult; #6 Anxiety She is prescribed lorazepam 0.5 mg which she takes when she has a panic attack which only occurs a couple times per year. For now we will just monitor. Diet: NPO; Tubes/lines: PIV; VTE prophylaxis: heparin infusion; Code status: Full Code; Disposition: anticipate discharge to home when clinically stable. Counseling was provided face-to-face at bedside regarding the plan of care as stated above. I personally spent over half of a total 70 minutes in counseling and coordination of care as documented above. M.B.B.S. at 3/30/2021 10:58 AM Status: Signed. SUBJECTIVE HISTORY OF PRESENT ILLNESS Patient is a very pleasant 56-year-old female who is owner of multiple nursing facilities who presented with chest pain and hypertensive emergency. She ran out of her hydrochlorothiazide last week, was fairly busy managing all her nursing homes with COVID pandemic and vaccination program. She was having intermittent chest pain, chest pressure radiating to the right arm. In this setting she checked her blood pressure, and it was noted to be 240 systolic over 140 diastolic. In this setting was sent to the ER and subsequently sent here. Initial troponin was 770. Subsequently, it went up to 1923. Delta was 862. ECG showed sinus rhythm with clear ST depression in the inferolateral leads. Patient currently is chest pain-free. She was initiated on carvedilol and restarted her home hydrochlorothiazide. Blood pressure is better. She had a good night's sleep. OBJECTIVE PHYSICAL EXAMINATION; Vital Signs: Noted.; General: Alert and oriented x3. Cardiac: S1, S2 normal.; Lungs: Clear.; Abdomen: Soft.; Extremities: No edema of feet.; Vessels: Peripheral pulses well-felt.; DIAGNOSTICS Creatinine is 0.7. Bicarb is 30. ASSESSMENT / PLAN Patient, is a 56-year-old female with obesity, hypertension, smoking, presented with hypertensive emergency. Blood pressure is better controlled now. She did have clear ST-T changes with troponin elevation, and we will treat it as NSTEMI at this point. Certainly, this can be demand ischemia in setting of hypertensive emergency, but she has multiple risk factors which would warrant coronary artery disease evaluation. We will plan for an angiogram today. We will get an echo today. Post that, we will reassess and see how things go. It appears that this was in setting of medication noncompliance. However, if this happens again, we may also look for other secondary causes of hypertension, especially with the fact that her bicarbonate was 30. All her questions were answered. DIAGNOSES: #1 Hypertensive emergency; #2 NSTEMI; #3 Obesity. M.B.B.S. DD: 03/30/2021 08:54:32 CT; DT: 03/30/2021 09:13:15 CT; Job ID: 914158020/mjb. Sedation Note by HCP at 3/30/2021 10:22 AM Status: Signed. INTERVAL HISTORY AND PHYSICAL PRE-PROCEDURE UPDATE H&P reviewed. The patient was examined and there are no significant changes to the H&P. PRE-SEDATION ASSESSMENT Consent Consents Obtained: written. The benefits, risks and alternatives to the procedure and the potential need for sedation or anesthesia as well as the names, roles, and responsibilities of healthcare team members performing significant interventional tasks were discussed with the patient and/or decision maker: yes. Indications / Reason for Visit. Procedure / Reason for Visit: coronary angiogram with possible intervention. Presedation Assessment. The following portions of the patient's history were reviewed and updated as appropriate: allergies, current medications, family history, medical history, social history and problem list: Yes. Review of Symptoms pertinent ROS negative. Physical Exam Mallampati: II - soft palate, uvula, fauces visible. Assessment Plan ASA Physical Status: class 3 - patient with severe systemic disease Sedation Plan: moderate sedation. Patient seen, evaluated, and approved for sedation: yes. Cardiology Fellow 11053 Discharge Instr - Referrals / Follow-Ups by HCP at 3/30/2021 11:18 AM Status: Written Take a copy of this after visit summary to your appointment(s).---------------------------------------------------- Monday, April 5th, 2021:-- 12:30 p.m. -- Hospital follow-up with Dr. primary care provider, at Medical Center------------------------------ --------------------------- You may have outpatient appointments at Clinic that changed during your hospitalization. Refer to your Clinic Patient Visit Guide (PVG) for the most current schedule of appointments and detailed instructions of tests/procedures. Call, if you did not receive an PVG or need to CANCEL any Clinic appointment(s). H&P by HCP at 3/30/2021 12:33 PM; Status: Signed; CARDIOLOGY 3 H&P HISTORY OF PRESENT ILLNESS; Patient is a 56 yo F with history of hypertension, dyslipidemia, smoking history, and obesity who presents with chest pain, found to have NSTEMI. She owns and runs 4 assisted living facilities. In the past three days, she has had chest pain at rest following dinner, while sitting in the living room. It has lasted from minutes to hours and was relieved on its own. Yesterday she was prompted by her husband to present for medical attention. She has smoked 1-2 packs daily for the past 40 years. She is on hydrochlorothiazide 25mg daily for her blood pressure. Blood pressure was 171/129 here in the ED. Troponins rose from 770 to 1061 to 1923. Current Medications: [MAR Hold] acetaminophen tablet 1,000 mg (TYLENOL), Q6H PRN; acetaminophen tablet 1,000 mg (TYLENOL), TID PRN; [START ON 3/31/2021] aspirin chewable tablet 81 mg, Daily; [MAR Hold] aspirin DR tablet 81 mg, Daily; atropine injection 0.5 mg, Q5 Min PRN; bisacodyl suppository 10 mg (DULCOLAX), Daily PRN; [MAR Hold] calcium carbonate chewable tablet 400 mg of calcium (TUMS), Q2H PRN; carvedilol tablet 25 mg (COREG), BID with meals; [MAR Hold] Clopidogrel tablet 75 mg (PLAVIX), Daily; [START ON 3/31/2021] Clopidogrel tablet 75 mg (PLAVIX), Daily; docusate sodium capsule 100 mg (COLACE), BID PRN; fentanyl injection 25 mcg (SUBLIMAZE), Q2 Min PRN; fentanyl injection 25 mcg (SUBLIMAZE), Once PRN; flumazenil injection 0.2 mg (ROMAZICON), Once PRN; heparin (porcine) 1,000 unit/mL injection 3,200 Units, PRN **OR** heparin (porcine) 1,000 unit/mL injection 6,400 Units, PRN; heparin (porcine) 100 Units/mL in NaCl 0.45% 250 mL infusion, Continuous; [MAR Hold] lisinopril tablet 2.5 mg (PRINIVIL,ZESTRIL), Daily; Lorazepam injection 1 mg (ATIVAN), Once PRN; midazolam (PF) injection 0.25 mg (VERSED), Q2 Min PRN; midazolam (PF) injection 0.5 mg (VERSED), Once PRN; midazolam (PF) injection 0.5 mg (VERSED), Q2 Min PRN; midazolam (PF) injection 1 mg (VERSED), Q2 Min PRN; NaCl 0.9 % bolus 250 mL, Once; NaCl 0.9% infusion, Once PRN; naloxone injection 0.2 mg (NARCAN), Once PRN; naloxone injection 0.2 mg (NARCAN), PRN; MAR Hold] nicotine 10 mg inhaler 1 puff (NICOTROL), PRN [MAR Hold] nicotine 21 mg/24 hr. 1 patch (NICODERM CQ), Daily; ondansetron (PF) injection 4 mg (ZOFRAN), Once PRN;[MAR Hold] polyethylene glycol powder packet 1 packet (MIRALAX), Daily PRN; promethazine injection 6.25 mg (PHENERGAN), Q6H PRN; [MAR Hold] rosuvastatin tablet 20 mg (CRESTOR), Daily at bedtime; sodium chloride 0.9 % injection 10 mL, PRN; sodium chloride 0.9 % injection 3 mL, PRN; sodium chloride 0.9 % injection 3 mL, Q12H SCH. OBJECTIVE BP 143/83 | Pulse 71 | Temp 36.6 °C (Oral) | Resp 21 | Ht 165.1 cm | Wt 104 kg | SpO2 94% | BMI 38.19 kg/m². Intake/Output Summary (Last 24 hours) at 3/30/2021 1212. Last data filed at 3/30/2021 1130. Gross per 24 hour Intake 323.71 ml; Output 700 ml; Net-376.29 ml; GEN: Pleasant, no distress CV: Regular, no extra heart sounds, JVP is flat; PULM: Clear bilaterally; EXTR: No edema, strong R radial pulse ; ;EKG: NSR, nonspecific changes. ASSESSMENT / PLAN NSTEMI, s/p PCI to circumflex 3/30/21; Hypertension, uncontrolled; Nicotine dependence; Dyslipidemia; Obesity. She has an NSTEMI with significant elevation in her troponin. We will proceed with coronary angiography for this and anticipate PCI. We will intensify her antihypertensive regimen. Nicotine cessation is critical and we will consult our cessation specialists. We will refer her to cardiac rehab. DAPT for 1 year. Plan:1. Coronary angiography with intervention today; 2. High intensity statin, uptitrate carvedilol, keep lisinopril 2.5mg, restart hctz later this evening.; 3. Nicotine cessation referral. Cardiac rehab referral; 4. F/u TTE. Addendum: Angiography demonstrated her culprit lesion to be in the circumflex for which she received a 2.5 x 16 mm synergy stent. Mild disease elsewhere. She will require DAPT for one year. The patient was seen and discussed with the attending consultant, Dr. and PA. M.D. Cardiology fellow 3/30/2021 Consults by HCP at 3/30/2021 1:51 PM Status: Signed Consult Orders 1. Cardiac Rehabilitation consult (hospital) [2222776702510] ordered by M.D. at 03/30/21 1136; 2. Cardiac Rehabilitation consult (hospital) [2222776391034] ordered by M.D., Ph.D. at 03/30/21 0343 Cardiac Rehabilitation Referral. Reason for Visit: Cardiac Health Clinic consultation for referral to cardiac rehabilitation. Liaison met with the patient/family to discuss cardiac rehabilitation referral. Patient/family was provided with progressive verbal and printed home-going exercise guidelines. Patient/family understands and agrees with the exercise guidelines.1. Participation in a Phase II cardiac rehabilitation program is recommended. Patient was informed about what cardiac rehabilitation has to offer and why it is beneficial. The plan of care for the rehabilitation program consists of risk factor modification, monitored and supervised exercise and assistance in the recovery process with ongoing education and support. Patient is interested in attending a cardiac rehabilitation program.; 2. Eligibility: MI and PCI; 3. Exceptions/exclusions: None;.4. Referral: Patient agreed with referral to a cardiac rehabilitation program. Please see discharge order and/or letter for program details. Clinic Health System Phone:; 5. Appropriate referral information will be sent to the receiving cardiac rehabilitation program as applicable. Patient provided verbal authorization to send relevant materials to the cardiac rehab program. Recommend that the patient check with insurance company to verify coverage of the cost of cardiac rehabilitation program visits. Discharge Summary by PA at 3/31/2021 10:20 AMStatus: Addendium CARDIOLOGY HOSPITAL DISCHARGE SUMMARY DATE OF ADMISSION: 3/30/2021 DATE OF DISCHARGE: 3/31/2021 Discharge Provider: M.B.B.S. Discharge Provider Team: RST CARD 3 PRINCIPAL DIAGNOSIS Non-ST Elevation Myocardial Infarction. DISMISSAL DIAGNOSES #1 Non-ST Elevation Myocardial Infarction; #2 Poorly controlled systemic hypertension; #3 Mixed hyperlipidemia, previously untreated;#4 Medically complicated obesity (BMI 38); #5 Abuse Tobacco Smoking, Nicotine Dependence; #6 Anxiety. RECOMMENDATIONS FOR FOLLOW-UP APPOINTMENTS CBC and Basic metabolic panel; Cardiovascular risk factor modification; Cardiac rehabilitation participation (set up); Nicotine cessation; Blood pressure monitoring and management; Plavix for one year, aspirin lifelong; Assess right radial access site. *Statin Therapy Initiated: *A fasting lipid profile showed: Total Cholesterol 173 mg/dL, Triglycerides 218 mg/dL, HDL 39 mg/dL, LDL 90 mg/dL. *Baseline LDL is [ ] mg/dl. Please titrate to meet goal lipid levels.*Please recheck lipids and ALT/AST in 6 to 8 weeks.*Goal of statin therapy is a LDL less than 70 mg/dl or a 50% reduction in LDL. FOLLOW-UP APPOINTMENTS For appointment details refer to your Patient Appointment Guide. HOSPITAL COURSE Admission Weight: 104 kg; Dismissal Weight: 103 kg; BMI: Body mass index is 37.82 kg/m².Patient is a 56 y.o. female who presented to the Emergency Department due to chest pain. She has experienced this pain each evening for the past 3 evenings, and states that it starts in her right arm then migrates through her shoulder and across to her chest. The pain can last for anywhere from 5 minutes to 4 hours. This has come on at rest, but in the setting increased personal life stressors as well as uncontrolled hypertension. She states that she is normally on hydrochlorothiazide for hypertension, but ran out of this medication about a week ago. When she checked her blood pressure at home it was in the 230s/120s, therefore she presented to the emergency department locally. Her medical comorbidities are notable for poorly controlled hypertension, mixed hyperlipidemia that is untreated, current tobacco use (1-2 packs per day for 40 years), and medically complicated obesity(BMI 38.19 kg/m2). Intravenous heparin was initiated for the heparin nomogram. She was Plavix loaded and received aspirin. Carvedilol, lisinopril and Rosuvastatin were initiated. She proceeded to coronary angiogram with drug-eluting stent to the left distal circumflex artery. Transthoracic echocardiogram demonstrated ejection fraction 63%. Nicotine dependence was consulted and provided cessation information and prescriptions for nicotine replacement therapy. TEST RESULTS PENDING AT DISCHARGE :Pending Labs; None; DISCHARGE DISPOSITION: Home or Self Care [1]; CONDITION ON DISCHARGE: Stable. DIET AT DISCHARGE: Cardiac diet consisting of low sodium (1500 mg to 2000 mg per day), low cholesterol, low fat. No alcohol, (or discuss with physician).PRIMARY PROVIDER Patient Care Team:D.O. as External Primary Care Physician (Family Medicine) Primary Care Providers: Pcp (General); No address on file Primary Care Provider Phone Number: None Primary Care Provider Fax Number: None MARGIN CODE Operative Note Report Case/Log ID: 1507626443 Case Time: 10:44 AM Procedure Information CORONARY ANGIOGRAPHY Laterality N/A; Left Heart Catheterization Laterality N/A; Percutaneous Coronary Angioplasty Laterality N/A; Stent Placement Laterality N/A. Surgeons Surgeon Role M.D. Primary M.D. First Assistant, M.D. First Assistant, Diagnosis. Pre-op diagnosis: Non-ST Elevation Myocardial Infarction , Morbid Obesity Body Mass Index >= 35 with Comorbid Condition. Post-op diagnosis: Non-ST Elevation Myocardial Infarction , Morbid Obesity Body Mass Index >= 35 with Comorbid Condition. Anesthesia Type Moderate sedation (rn). Surgeon Documentation. No notes of this type exist for this encounter. Specimens None. Implants Implant Name LRB; Site No. Used; Manufacturer Mfr No.; Serial No.; Status; Type STNT SYNERGY XD DE 2.50X16 - LOG1507626443 N/A; Coronary Scientific H7493941816250 Implanted Cardiac Stent; Drains None Estimated Blood Loss None. Worsening shortness of breath COVID-19 positive on 06/06, Sxs started on 06/01 HPI: This is a 61 year old female who presents with complain of worsening Shortness of breath, COVID-19 positive PMHx Kidney transplant for glomerulonephritis, 1998, 2nd transplant in 2009 on Cellcept and prednisone and recurrent UTIs since then and since then when she gets UTI, she starts Cipro or Keflex HOCM myectomy 2009. Just saw yesterday. Denied CP/ SOB/ orthopnea/ cough/ leg swelling/ syncope/ PND. stated " no gradients across LVOT. At acceptable risk for planned procedure. Afib in 2009, Legally blind, Gout, Hand amputation 2017 at work , Hip replacement Ventriculostomy - cyst removed 1999] Pt completed COVID vaccination series (Pfizer 2/25/21, 3/18/21) but has been on immunosuppression 2/2 renal tx. Her symptoms have been persistent since 6/1. She states that she has been having fever morning and evening, cough, fatigue. She states that over the past 1-2 days prior to presentation to the ED she has had hypoxia to 85-89% on home pulse ox and intermittent episodes of fever, pt reports worse dyspnea w/ ambulation. Pt called her nephrologist on 06/01 and recommended course of Amoxicillin w/out improved, given worsening and not improving sxs her nephrollogist recommended to presented to the ED, On arrival to the ED she was initially tachypnic with ambulation to the bed, but has since improved. On initial exam she is not in any acute respiratory distress. CXR showed finding of viral PNA, Creatinine 1.17 baseline < 1.0 Sodium 126 This is a 61 year old female who presents with complain of worsening Shortness of breath, COVID-19 positive PMHx Kidney transplant for glomerulonephritis, 1998, 2nd transplant in 2009 on Cellcept and prednisone and recurrent UTIs since then and since then when she gets UTI, she starts Cipro or Keflex HOCM myectomy 2009. Just saw Physician yesterday. Denied CP/ SOB/ orthopnea/ cough/ leg swelling/ syncope/ PND. Physician stated " no gradients across LVOT. At acceptable risk for planned procedure. Afib in 2009, Legally blind, Gout, Hand amputation 2017 at work , Hip replacement Ventriculostomy - cyst removed 1999] Worsening shortness of breath COVID-19 positive on 06/06, Sxs started on 06/01 On arrival to the ED she was initially tachypnic with ambulation to the bed, but has since improved. On initial exam she is not in any acute respiratory distress. CXR showed finding of viral PNA, Creatinine 1.17 baseline < 1.0 Sodium 126 Active Problems: Active respiratory failure dute to COVID-19 Hypoxia Symptomatic 6/1, tested positive for COVID infection 6/6. Currently sat 93-95% on RA; States she sats down to 85% at night. Short of breath on ambulation Xray findings suggestive of atypical viral/Covid 19 pneumonia. Plan: - dexamethasone, remdesivir, mucinex - Oxygen NC to keep SpO2 >94% - IS q1h - ID consult appreciate recommendations - Mucinex,Sch, robitussin PRN and albuterol PRN - Incentive spirometry Kidney replaced by transplant Aki Increased creatinine 1.77 baseline Hyponatremia Hypochloremia - Creatinine 1.17 from 0.95 possible d/t dehydration. - Na 126, Cl 94 Plan: - Normal saline bolus - Hold cellcep - Continue tacrolimus - Prednisone hold, due dexamethasone for tx of COVID infection - Hold lasix, allopurinol, lisinopril - Continue valgancclovir - Avoid Nephrotoxic agent - renally dose meds - Gentle IVF NS 75 ml/hr - Usodium and Uosm Hypertension Hypertrophic obstructive cardiomyopathy (HOCM) (HCC) Atrial fibrillation (HCC) DVT prophylaxis - Normal sinus rhythm on EKG Plan: - Heparin - Continue atorvastatin, ASA, coreg - Monitor for palpitations, dizziness, headache, SOB - Holding Lisinopril and Lasix in setting of Aki - Continue Coreg Gastritis - currently asymptomatic Plan: - Protonix while on Steroids Prediabetes - Hgb A1C 6.1 4/3 Plan: - Low carb diet Legally blind - Patient moves about room without difficulty

Systemic: Blood Disorder (diagnosed by MD)-Severe, Systemic: Hospitalized with PE per family member-Severe

Patient presented to the ED immediately after receiving dose 1 of vaccine with anaphylactic reaction. Patient had hives, difficulty swallowing. was given epinephrine, prednisone taper and benadryl.

Patient received COVID-19 vaccine (Pfizer) on 3/17/21 and 4/7/21. On 6/22, she required admission to hospital due to SOB. Pt presented with "gradually worsening SOB in last 10 days with frequent wheezing and productive cough of white sputum. She is a former smoker; quit 1 month ago. Desatting to 80s with fever." COVID-19 positive on 6/22; COPD exacerbation also noted. Seen in outpatient pulmonary clinic on 6/14: "Patient is on 1.5 L O2 during the day and 2 L during the night since last year." Hx of ILD. Patient still hospitalized at this time for COPD exacerbation and NSVT. Reporting due as a breakthrough positive case per EUA requirements.

heart skipped beats and Afib following the first dose and continuing for ~ 2 weeks after second dose and then stopping completely

On 4/28/2021 the patient began to develop tiredness, dizziness, and a fall. The next day she went to her PCP who scheduled her for an MRI to check for TIA. The brain MRI was performed on 5/3/2021 and showed a small recent infarct involving the right corona radiata/deep white matter of the right parietal lobe. Patient was diagnosed with a CVA.

Anaphylaxis; Rash; urticaria; This is a spontaneous report from a contactable Physician. This Physician reported in response to other health professional letter [sent to physician] via follow-up. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8732) via intramuscular in the right deltoid on 12Apr2021 (at the age of 61-years-old) as dose 2, single for covid-19 immunisation. Medical history included history of previous allergies to PNC (penicillin), codeine, amitriptyline and latex. Patient received antihistamine for the treatment of allergies. Concomitant medications included trazodone, vitamin C (ascorbic acid), calcium citrate, linum usitatissimum seed (FLAXSEED), topiramate (TOPAMAX), zolmitriptan (ZOMIG), norethindrone (norethisterone), ethestradiol (desogestrel, ethinylestradiol (ETHISTREL)), esomeprazole sodium (NEXIUM), valaciclovir hydrochloride (VALTREX), linaclotide (LINZESS), cyanocobalamin (VITAMIN B12), and colecalciferol (VITAMIN D) all taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP7534), via intramuscular in the left deltoid on 22Mar2021 (at the age of 61-years-old) as dose 1, single for covid-19 immunisation and on an unknown date in Mar2021 patient had rash/hives. The patient did not receive any recent vaccines, for any other conditions and for SARS-CoV2 other than Pfizer-BioNTech Covid-19 Vaccine, prior to the event being reported. On 13Apr2021, the patient experienced anaphylaxis with signs and symptoms rash and urticaria. First saw patient on 13Apr2021, 1 day after 2nd dose, she reported rash/hives since 1st dose in Mar. The patient required medical intervention with corticosteroids and antihistamine. It was reported that Pfizer product had a causal effect to the adverse event. The outcome of all the events was recovered in 2021. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Anaphylaxis, rash, urticaria and the suspect drug BNT162B2.

On June 17th early to mid-morning I started to have pressure in my chest. Like someone was sitting on my chest. I started to have pain go down my arm. I went to the urgent care and they did an EKG and they determined that I had a heart attack. They transferred me to the hospital, and they did an Echo Cardiogram and other test to confirm that I did have a heart attack. The cardiologist confirmed that I had a heart attack due to SCAD.

I am 8 years post menopausal and on estrogen /progesterone for menopausal symptoms. Develop bleeding post 2 nd covid vaccine. Went to GYN and stopped hormones to check biopsy and US for cause. Still waiting. Bleeding did stop after stopping hormones

I went into antiflactic shock, brought over to the hospital, was given intravenous drugs and benadryl. Had to stay for 6 hours.

I got my shot on the 19th and that evening it was like a light switch and I was so tired I went to sleep at 730pm I had severe chills and fever and had to go to bed. The next day I still wasn't feeling well and I was called in to get covid tested and I went to the ER on the 21st and took a rapid covid test that was positive. I was stable and had good oxygenation and was discharged. I have fever nausea vomiting I also had problems with O2 stat i was in the 80s and realized I was having respiratory failure so I was admitted on the 27th and I've been here ever since. I had kinetic storm and infusions my O2 stats were bad and I was sent to the covid unit and put on high flow oxygen and negative for a PE, I'm still on the covid unit but I feel much better today

Patient 00037022 DOB 03-21-1958 received 2nd dose Pfizer lot EL1284 on 1-6-2021 in left arm. She has not had history of reaction before. Starting from midnight that night she has fever between 100.6-101.2, body aches and stiff neck. She also has swollen left arm pit, head ache, Pruritus breathing. She has a history of afib and last night she had two runs of it and took metoprolol.

Atrial fibrillation; Was not feeling well; Warm sensation in chest; This is a spontaneous report from a contactable nurse (patient). This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EJ 1685), intramuscular, on 21Dec2020 at 09:30 PM at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was vaccinated at hospital, age at vaccination was 62-years-old. The patient received also varicella zoster vaccine RGE (CHO) (SHINGRIX) on 19Nov2020. Medical history included gastrooesophageal reflux disease (GERD) and high cholesterol. Concomitant medications included omeprazole, colestyramine (QUESTRAN), and vitamins. On 22Dec2020, the patient was not feeling well intermittently starting the day after the injection with warm sensation in chest that would go away until 31Dec2020 when the warm sensation of chest would not go away. The patient was sent for EKG that showed atrial fibrillation that she is now being treated for. The events resulted in doctor or other healthcare professional office/clinic visit. The events were reported as non-serious. Outcome of the events was unknown.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported atrial fibrillation and the administration of COVID 19 vaccine, BNT162B2. More information regarding the clinical course, the patient's underlying concurrent medical condition are required for the Company to make a more meaningful causality assessment. 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, Agency, as appropriate.

1st 24 hrs just arm soreness, 2nd 24 hrs itching and fatigue, 48 hrs, anaphylaxis, hives, rash, itching, lymph swelling, chills

Pt had 3 vessel CABG on 1/14/21 after presenting to ED with chest pain on 1/9/21. Pt is critically ill following OR after cardiogenic shock, bleeding. Requiring inotropes and Impella.

She said she received her First Covid vaccine on 12/22/2020. She said on 1/4/2021 she worked that evening and started having severe pain in calf of her left leg no redness ,no heat, just hurt to work 1/8/2021 She had surgery on her left leg. 2nd Covid Vaccine received on 1/12/2021 She said she had PT on her right leg with severe pain in her left calf She said she did not have any therapy on her left leg. Two ? three hours later she developed chills, temp 100.1 took temp again later is was 99. She had ultrasound that showed a large blood clot She said the PA told her the blood clot could be from receiving the Covid vaccine

she was injected, sh stopped eating and talking, the doctor watched her for 2 days. had her transported to the hospital. i was told she had tested positive for COVID 2 times once at the home and once at the hospital. with in 2 DAYS at the hospital she wa on a ventilator 2 days later she died. i talked with the rehab center and confirmed she tested negative for COVID on Dec 27th 2020 and was given the Vaccine on the 29th Dec 202 was in the hospital 4 day later, was on a ventilator 4 days after that then died a few day later as her heart stopped beating. all the while i had POA and was not contacted by Hospital staff until after they had made the next step.

Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21

Pfizer-BioNTech COVID-19 vaccine EUA---- 2/4/21 0430am woke up with numbness in left leg which progressed to entire left side of body. 02/05/21 03:30 PM presented to ER for evaluation of left side body numbness. Numerous test & blood work performed. D/C home with diagnosis of transient cerebral ischemia & instructed to follow up with neurologist.

The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.

she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed; the lymph node under her arm got inflamed; armpit swelling; her eyes was runny, sort of hurting like salt in her eye; her eyes was runny, sort of hurting like salt in her eye; arm was hurting where she got the vaccine in the right arm; she had a mucus plug and was bleeding; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 62-years, via an unspecified route of administration in right arm on 19Feb2021 at single dose for COVID-19 immunization. Medical history included hadn't had her period for 8 years. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 at the age of 62-years for COVID-19 immunization. Patient received the 2nd dose of the vaccine last Friday 19Feb2021, when she was driving home her eyes was runny, sort of hurting like salt in her eye, it was like that all evening she had to put a patch on her eye to help it. That same evening may arm was hurting where she got the vaccine in the right arm, and the lymph node under her arm got inflamed. The next morning on 20Feb2021 when she woke up she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed, but that went away. The armpit swelling has continued since the day of the vaccine. Now this morning in Feb2021 she had a mucus plug and was bleeding she haven't had her period for 8 years, every two days she had something new. Patient wanted to know what had been woken up in her body. Consumer added that she read on line that patients should wait for 5months before going to their doctor about the swollen lymph nodes because they might send the person for a test, mammogram and it may say they have cancer, in the clinical trials apparently some patients has issues with their lymph nodes and when they did testing it was found they had cancer, but it was not cancer it was the vaccine. Outcome of the event she felt something in her foot (right foot) under the toes like she had sept on something like the lymph node down there was inflamed was recovered/resolved in Feb2021; of the armpit swelling was not recovered/not resolved; while of remain was unknown. Information on lot/batch has been requested.

Allergic-Anaphylaxis Itching 17 min after administration, redness, rash, chest pressure under heart. Facility called 911 administered Benadryl via IV transported to ER Once in ED given Epipen at 2:21 and Decadron @ 6:05, discharged at 6:60 pm

Pfizer-BioNTech Covid vaccine, first shot developed a blood clot in a superficial vein the day after the vaccine, was diagnosed by a doctor as "superficial thrombophlebitis, pain swelling in leg. Treatment of ibuprofren started. Wondering if I should take my second shot which is scheduled for MArch 26

Patient was found in house by EMS with agonal respirations. Patient was intubated on scene and brought to ER. At ER, patient presented with a HR of 55, BP of 80/43, O2 of 99%, and a rectal temperature of 107.3F. Further work-up revealed thrombocytopenia with a platelet count of 63, WBC of 13.7, and an elevated lactate of 2.2. Imaging shows a kidney stone obstruction of the right ureter. Diagnosis of sepsis was made with patient admitted to the hospital. Repeat rectal temp after acetaminophen suppository and external cooling continues to be 107. Care is ongoing at time of this report.

blood clot formed in left arm; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient, not pregnant at time of vaccination, received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198), via an unspecified route of administration, on right Arm on 27Feb2021 0100, SINGLE DOSE for covid-19 immunisation. Medical history included Diabetic, High blood pressure, both from an unknown date. Concomitant medications included glipizide, metformin, fenofibrate. The patient previously took sumatriptan succinate (IMITREX) and experienced drug allergy. After vaccination 6 days later (05Mar2021) a blood clot formed in left arm. Shot was given in right arm. Hospitalization followed and now on blood thinners. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 2 days. The outcome of the event was not recovered. Eliquis was given as treatment for the event. No covid prior vaccination. Not covid tested post vaccination.

Patient received first COVID-19 dose on Jan 14th, 2021 and then developed chest pain and diarrhea 1 day later. On Jan 17th, she presented to hospital and was found to have an non-ST elevated MI and apical ballooning syndrome.

Patient suffered right temporal subarachnoid hemorrhage. Conventional angiogram is negative for aneurysm, AVM, or vasculitis. Patient denies trauma prior to the event. Denies using OTC pseudophed or other decongestants. Denies illicit drug use.

patient had headache within the first 15 minutes after administration and was found to be positive for dural venous sinus thrombosis with unknown etiology

Began feeling unwell, had urinary urgency, and was itching shortly after 2nd dose of Pfizer COVID-19, then found obtunded due to pulmonary embolus resulting in death within 24 hours of receiving 2nd dose

Severe pain in right side radiating up to shoulder. Diagnosed as a Pulmonary Embolism. On April 7, 10 days after second Pfizer Covid vaccination shot, (administered on March 26), patient developed severe pain in her left leg. Numerous tests for blood clots proved negative and on April 10 she developed a rash and blisters which is believed to be Shingles.

Slight headache that day (4/1). The next day (4/2), weakness in left leg and arm. On 4/3 went to ER, admitted to NeuroScience ICU. Diagnosed with small blood clot and small bleed in brain--- dural venous sinus thrombosis. The neurology team said this was very unusual and very rare in this part of brain--where the blood flows back to the heart from the brain. They did alot of tests on every part of my body looking for the cause and found nothing. They think it was vacine induced and repoted it to the CDC. Left leg and arm weakness remains with no changes yet. Now taking blood thinner and doing physical therapy

Pfizer-BioNTech COVID-19 Vaccine EUA: six days after immunization patient presents with shortness of breath, myalgias, cough, headache, and chest pain. Hospitalized with acute hypoxemic respiratory failure secondary to COVID-19 infection: administered steroids, antivirals, and anticoagulation. Patient currently hospitalized.

Patient presented complaining of worsening SOB over the past 3 days. She reports leg swelling, as well. Patient was found to have a heart failure exacerbation and critically high potassium, prompting admission to the hospital. Patient received calcium gluconate, insulin, dextrose, and Kayexalate.

Extreme dizziness and vomiting occurred 4/10/21. Diplopia and numbness began on 4/11/21 and continued. MRI and CT scans confirmed that the patient experienced a transient ischemic attack (TIA) and Veretebral artery dissection (HCC) between 4/10 and 4/11.

After initial two days of side effects of temp and fatigue, nausea, continued side effects of extreme fatigue, nausea low grade temp for ten days, fatigue got worse; resulting in extreme shortness of breath. i went to the emergency room where i was diagnosed with AFIB. I spent 6 days in hospital. No previous condition of AFIB. An exam and physical in July did not reveal any health issues.

4/4 2021 - Red raised Rash at the injection site about the size of a quarter 4/5 2021 _ Itchy raised rash, sore to the touch about the size of a dollar piece 4/6 2021 - Itchy raised, hard and hot. sore to the touch about 3" round 4/7 2021 - Itchy raised, hard, sore to the touch about 3 1/2" round Called Dr. Was told to take Benadryl, Tylenol, compress If no improvement the next bay then I had to come in to the office. I started to see some improvement-not as red. over the next two day it continued to itch less, redness was fading, still itchy and hard. By the 11th they swelling was down to the size of a quarter and redness was gone but still itchy. 4/18 it was about the size of a pea still a little itchy but doesn't hurt and no redness. However, on 4/13 around 6:30 pm I had to be rushed to the hospital couldn't breath, vision and speech was declining . was admitted for blood clot that cut the oxygen to brain causing a mini stroke

Information obtained from the Hospital. Began to not feel well the next day, SOB, diarrhea and fatigue. Was admitted to hospital on 4/9/21, diagnosed with COVID, placed on a vent and died on 4/19/21.

Resident was given the vaccine on 4/8/21. She had a stroke/heart attack when she was being taken to the bathroom on 4/13/21 around 8:30pm. She was admitted to the hospital and at this time I believe she is still hospitalized. We were unsure if this was related to the vaccine or her general health condition as she is recently started dialysis and they discovered a pituitary cancer when doing a scan for the stroke on 4/13/21 or 4/14/21. We talked with our Medical Director and thought it would be best to report this since it happened shortly after her first vaccine dose.

My first dose was administered on Mar. 5th, 2021. On March 18th, 2021 I had a spontaneous anaphylactic reaction requiring the use of Benadryl and an inhaler. 40 minutes after second injection (Apr. 2nd, 2021) my face became bright red - which is usually the beginnings of an allergic or non-tolerant reaction to something to which I've come in contact. A Benadryl dose resolved this reaction within 20 minutes. On April 10th I had a spontaneous anaphylactic reaction requiring the use of Benadryl. 12 Days after second dose I noticed my tongue feeling raw and started feeling a UTI beginning. By 14 days after second dose I had approximately 14 pea sized lumps on the back and back sides of my tongue, the gums of my teeth were very swollen and sore. The roots of my teeth ached terribly, chewing was very difficult. My ears were both very itchy deep within. I was seen my my physician on April 20th, 2021 and diagnosed with Candida Overgrowth.

TIA - mini stroke/transient ischemic attack. Started with loss of ability to speak/understand, weakness of left arm and leg, headache, slurring of words - 3 days in Hospital - resulted in damage to memory, confusion, weakness in left arm+leg, severe headaches - ongoing, but slightly improved after 3 weeks. Also diagnosed with acute cerebrovascular accident.

-Patient died unexpectedly on Thursday, April 22, 2021 at her home (found unresponsive by spouse) -No reactions were observed at the pharmacy (within 15 min waiting period) following either covid-19 vaccine (1st dose administered 8am on 3/26/21 -Left Deltoid) -When asked (4-16-21) how she tolerated the 1st dose, Patient reported minor side effects (mild Headache, tiredness) but had no reservations about receiving the 2nd dose. No additional information.

Severe anaphylactic-like reactions to foods started /Throat swelling, closing; Numbness of lower part of face; throat constriction, lasted for 45 minutes; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6205), via an unspecified route of administration on 03Mar2021 10:00 AM as single dose in right arm for COVID-19 immunisation. The patient's medical history included auto-immune disease, RA, Hashimoto. Patient had no prior allergies except to bee venom. Patient was not pregnant at the time of vaccination. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. 60 minute after the shot, throat constriction, lasted for 45 minutes. On 20Mar2021, the patient experienced severe anaphylactic-like reactions to foods. Patient experienced throat swelling, closing, numbness of lower part of face which resulted in emergency room visit and physician office visit. Reactions are muted since taking antihistamines but persisted even on 08Apr2021. Adverse events treatment included Allegra, Zyrtec. All allergy tests were negative. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was not recovered.

I went for a regular checkup and Dr noted HR was elevated 130 which is abnormal for me. She did an EKG and noted an arrhythmia, tachycardia and then did 2nd EKG noting that it showed AFib. Had no symptoms at all. Was sent to ER, HR up to 160, gave me IV Diltiazem which decreased HR to 120 and they did an echocardiagram. When laid on L side for echo, heart back into rhythm at 90. Kept me overnight on heart monitor in observation and sent home on Lovenox then Warfarin and now taking Eliquis 5 mg bid and Oral Cartia XT 300 mg daily.

My partner felt pain overnight. Then, felt flu like symptoms- plus chills- the next day and night. The following morning at 7:00 am, Patient said that she felt real sick. She also, complained of having a real bad Headache, Not long after that, she felt like throwing up. She tried to throw up. Except, nothing came out and she felt very nauseous because of the vaccine. When she came call to bed, I offered to make her some breakfast to help her feel better. Unfortunately, she felt, too, I'll to try and eat an food because of the way she felt. So, I laid next to her with the hope that all would be well. Because, the pharmacist who administered the second dose. Assured my partner, that it was normal to feel flu like symptoms the next day. So, we never doubted what the pharmacist advised. All of sudden, she suffered a cardiac arrest in my presence and died in front of me.

Doppler showed a blood clot; Pain behind her cast; Really bad case of diarrhea; Swelling in her knee; Leg was swelling/right shoe was tight; Lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; It was tender on her right leg on the left side of the tibia/It is very tender to the touch; Red mark on her leg with a little nodule; Red mark on her leg with a little nodule; Calf pain; This is a spontaneous report from a contactable consumer. A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7533; Expiration date was not reported) on the right arm on 30Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization at the clinic. Medical history included pain and headache. Concomitant medications included paracetamol (TYLENOL ARTHRITIS) for pain; hydrocodone for pain; amitriptyline for headache; and ongoing paracetamol (TYLENOL EXTRA-STRENGTH) for pain. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6208; Expiration date was not reported) on the right arm on 11Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 07Apr2021, the patient's doppler showed a blood clot. On 30Mar2021, the patient had a really bad case of diarrhea; swelling in her knee; and leg was swelling/right shoe was tight. On 02Apr2021, the patient had pain behind her cast. On an unspecified date in 2021, the patient's lower extremity venous ultrasound showed right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein; was tender on the right leg on the left side of the tibia that was very tender to the touch; had a red mark on her leg with a little nodule; and had calf pain. The events had resulted into an emergency room visit and physician's office visit. The patient had received treatment for the events, 'blood clot', 'lower extremity venous ultrasound right calf vein acute deep vein thrombosis of the right lower extremity involving the popliteal vein', 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'tender on her right leg on the left side of the tibia that was very tender to the touch'. The outcome of the events was recovered on 30Mar2021 for 'really bad case of diarrhea'; was recovering for 'leg was swelling/right shoe was tight', 'pain behind her cast' and 'red mark on her leg with a little nodule'; and was unknown for all the other events.

pt experienced SOB and was seen by pcp and referred to ER where evaluation identified PE and DVT of There is deep venous thrombosis present within the left popliteal vein which is nonocclusive and may be acute on chronic. Acute appearing deep venous thrombosis is present within both of the left posterior tibial veins which is occlusive. Likely acute deep venous thrombosis is present within the proximal aspect of a left peroneal vein focally.

To check if it was blood clot; Intermittent long-lasting palpitations; Lymph discomfort in one leg; Severe pain of bones in chest; Joint pains; Severe shooting intermittent head pain; Cold sweat; Felt like she was going to faint; COVID arm popped out; Severe nerve pain behind ear same side as vaccine; Exacerbated back pain; Bad menstrual cramps; This is spontaneous report from contactable consumer (patient). A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8727), via an unspecified route of administration in left arm, on 31Mar2021 at 01:00 PM (13:00), as first dose, single, for COVID-19 immunization. The patient's medical history included fibromyalgia, complex regional pain syndrome (CRPS), lymphedema (previously resolved), mild asthma, osteoporosis, herniated discs, allergies, and menopause. The patient's concomitant medications included unspecified vitamins. The patient had no other vaccine in four weeks (however, it was also reported that other vaccine was administered in same date, 31Mar2021; pending clarification). The patient was not diagnosed with COVID-19 prior vaccination. On 03Apr2021 at 02:00 AM, the patient experienced intermittent long-lasting palpitations, lymph discomfort in one leg for which they went to check if it was blood clot. On 03Apr2021 at 02:00 AM, the patient also had severe pain of bones in chest, joint pains, severe shooting intermittent head pain, cold sweat, felt like she was going to faint, COVID arm popped out (nite 8; as reported), severe nerve pain behind ear same side as vaccine, exacerbated back pain, and bad menstrual cramps for 2 mornings 11 years post-menopause. The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was received for the adverse events. The events were considered non-serious. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events. No follow-up attempts are needed. No further information is expected.

She got her vaccine in the left arm, and felt fine. She went shopping in the store and noticed that she was short winded when she was leaving, but felt that it was possibly asthma and left. She had a temperature between 102 and 103 for a couple of days and having fever and chills as well. She continued with the shortness windedness, and had company and on 5/9/21 they left and she started having severe pain, felt like it was either on the right side kidney or the lung, and was spasming horribly and knocking her down with the pain. She went to the ER and they did a CAT Scan thinking it was kidney stones, but told her that she had three blood clots in her lungs, lower base right and lower base left and mid right and part of her lung has apparently died due to this. They put her on blood thinners, Xarelto. She was admitted on 5/10 early morning and released on 5/12/21. The doctor in the hospital said that it did not make sense that she had blood clots in her lungs, but nothing in her legs. She told her that she was short winded, and he told her to report her reaction. Since being home she has been coughing a lot due to possibly the blood clots. She was told that she will be on the Xarelto for a very long time. She was also informed that she had lymph node enlargement as well.

Severe chest pain extending into left collarbone, and shoulders began on May 2nd and 3rd. Thought it could be muscular from heavy lifting over the weekend. Self treated with steroids for 2 days, and the problem resolved. I did not seek medical care. On May 10 and May 11, the pain returned. This time I knew it was not muscular so sought medical treatment. After describing to my physicians office I was advised to go to the ER.

Pt had second dose on 4/1/2021 and tested positive for COVID on 5/18/2021. Received antibody infusion on 5/20. Was admitted to the hospital on 5/21/2021 for pneumonia secondary to COVID-19 infection.

Had episode of ovarian cyst pain 1/20/21 in am. Went home, rested, pain eased a little. Able to finish work week but still bloated & cra.mpyNo nausea, no diarrhea. 1/23/21 felt like coming down with UTI. Rested, hydrated. Passed 2 small blood clots. Had a telehealth visit. Prescribed Levequin & Flagyl. Told to call PCP, needed a CT to rule out kidney stone. Saw PCP 1/27/21. Drew lab & ordered CT of pelvis. CT done 2/3/21. Consult with Oncology poss. Ovarian Ca. 3/15/21 had Robotic Total Hysterectomy- no cancer.

After the vaccine, a few days later , in the evening, my right leg felt sluggish / lazy. The next morning visited ER clinic from there I was admitted with possible stroke. From there, I was admitted to Hospital. MRI confirmed I had a mini-stroke. Was recommended physical therapy for right leg and to take 80 mg aspirin daily. Was hospitalized from 03/27/21 to 03/29/2021

blood clot already eliminated; pain; This is really miserable because it persisting and it is always there; I feel like frustrated; light pink rashes in the back from knee above in both legs; both of my legs below the knees had really bad itches; mild pain in the back of the upper left leg; sharp pain at a spot in my left hip joint; Sore in the injection area; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 15:30 (Batch/Lot Number: EW0169; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation, age at vaccination 62 years old. Patient is not pregnant at vaccination time. Medical history included diabetes mellitus from Sep2020 to and blood pressure (abnormal) from an unknown date. Concomitant medications included metformin taken for diabetes mellitus, start and stop date were not reported; dapagliflozin propanediol monohydrate (FARXIGA) taken for diabetes mellitus, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for blood pressure (abnormal), start and stop date were not reported. Clinical course was reported as follows: On 24Apr2021 noon (12:00), patient suddenly felt a shar at a spot in her left hip joint. It was then moved to the mild pain in the back of the upper left leg, which never disappeared. The pain there got a lot worse, so severe, also reported as now just a mild pain. Patient went to bed around 12 am on 25Apr2021, both legs below the knees had really bad itches; by next day 6 AM it was gone and never returned. On 26Apr2021, in late afternoon, in the back of both of the legs started bad it itches, and patient saw light pink rashes in the back from knee above in both legs, which disappeared by midnight, and never again noted. Sore in the injection area (Apr2021) similar to flu vaccine, which was gone after a few days. Patient stated adverse reaction getting worse and asked how it can be resolved because he can't function normally because of adverse effect. Patient stated that this is really miserable because it is persisting, and it is always there. He stated he is a normal person his breath, he still sees, still read, and is sound. He feels he is in constant pain, mild pain is annoying, but this week is so worse. Patient stated his "blood clot already eliminated" (onset date unspecified, event not clarified). Patient felt frustrated. Second dose was scheduled on 14May2021, but he didn't take it, he cancelled the second dose because of pain. Treatment was not given for the events (does not take medications). Outcome of the events "blood clot already eliminated" was recovered on an unspecified date, "both of my legs below the knees had really bad itches" was recovered on 26Apr2021, "light pink rashes in the back from knee above in both legs" and "Sore in the injection area" was recovered on Apr2021. Outcome of "sharp pain at a spot in left hip joint" and "mild pain in the back of the upper left leg" was not recovered (persisting for three weeks). Outcome of the other events was unknown. Seriousness reported as non-serious. Follow up needed, further information has been requested.

Loss of smell; Lung infection; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the right arm on 09Apr2021 (09:00) as a 2nd dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient had no relevant medical history and concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN620F; Expiration date was not reported) on 19Mar2021 (when the patient was 62 years old) for COVID-19 immunization. On 24May2021, the patient had lung infection. The patient went to the doctor (physician's office visit), and was put on antibiotic (doxycycline 100 mg, by mouth twice daily) and hydrocodone every six hours as treatment for the lung infection. On 28May2021, the patient had loss of smell (could smell some things but not others). The outcome of the events was not recovered for loss of smell; and was unknown for lung infection.

Few days after receiving the vaccine around 4/25, my mother complained to me that she was feeling very weak and tired, she was unable to hold anything down. She also had a rash. She became weaker and weaker so suddenly and unable to even drink protein drinks. She finally went to the ER on 5/4 because she could barely walk, unable to eat anything and was short of breath. They diagnosed her with pneumonia and a possible lung mass. She was diagnosed simultaneously 10 days later with small cell lung cancer however she had no symptoms prior. She received first dose chemo on 5/20/21 and had a reaction to the chemo that the doctor stated was very rare. They then had to try a different type of chemo for second dose 2 days later. She progressively got worse suddenly after chemo dose #3 and was in renal failure the day following chemo completion. She died on 5/27/2021. Her primary death diagnosis was sepsis, pneumonia and small cell lung cancer. I am reporting this for my mother because the vaccine has not been tested on cancer or chemo patients. It can and should not be regarded as coincidental. It needs to be tracked in case there are future reports regarding cancer patients.

Systemic: Blood Disorder (diagnosed by MD)-Medium, Additional Details: Patient reported that within 1 hour of receiving vaccine, she noticed leg pain and swelling. She went to the ER where she was diagnosis with a blod clot in the lower leg. The patient was started on a blood thinner (Eliquis) to treat DVT and prevent further clotting. Patient reported that she swelling and leg pain has gone down significantly but she still notes some swelling at the site of the clot.

She had a stroke (brain hemorrhage) due to a blood clot, required surgery to correct after a three-week stay in the hospital. She now requires physical therapy.

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

On March 28th, 2021 I had a TIA and had to go to the emergency room via ambulance and was admitted to Hospital. I was having trouble speaking and was very confused. I had no risk factors for stroke and they have since found no reason for my TIA.

severe fatigue, fever chills within 24 hrs lasting 2 days after second dose fatigue, bruises, petechiae after second vaccine diagnosed with ITP on 5-20-21

Patient reported to friend she felt ill and had sudden cardiac arrest. ROSC after 1 hour. Found to have STEMI; trop >100 with trending over past 24 hours. Has likely significant anoxic injury, prognosis is grim. Because apparent MI occurred within the original Pfizer trial study period of 14 weeks, and also at our institution we have had 2 other cases of early age and unexpected fatal MI's s/p vaccine, decision made to report this case as potential vaccine adverse reaction.

Immediately following the second dose, I had a lot of trouble with insomnia and nightmares that continued for almost 3 weeks. The nightmares stopped and even tho I am 9 years POST menopausal, I began bleeding again on April 28. Basically, it has only stopped for 3-4 days at a time in between. And I have been bleeding almost constantly ever since except for 10 days. I have had a uterine biopsy at Hospital. And Ultrasounds and there are no issues other than my uterine tissue is thicker than it should be. My joints are painful and enlarged too. That began at the beginning of May. I have had xrays and have been treated with steroids to get the tissue under control. I also am now experiencing Night Sweats and Hot flashes. Mayo doctors believe I need a hysterectomy or D&C to stop the bleeding issue.

Patient hospitalized for CHF (congestive heart failure), NYHA class IV, acute on chronic, diastolic within 6 weeks of receiving COVID vaccination.

I experienced lymph nodes under my left arm and to the back of my left shoulder blade which lasted a couple of weeks. I also developed pneumonia which I did not know I had which resulted in me having a flat lung, right lung base. I do not know if me having pneumonia was in correlation to the vaccine. I do not have the lymph nodes today under my left arm. I still have issues with my right lung which I am currently being treated. I do not have lot# to provide.

weakness on her left side; her left side and foot feels numb; her heart was off the charts; Feels like from her foot from the ankle down, is swollen on the left side; Felt like her throat was burning down to her chest; anaphylaxis; had a hard time breathing; could not swallow; Ungodly taste in her mouth, god awful taste in her mouth; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 02Jul2021 10:30 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation . Medical history included cerebrovascular accident from 1995 to an unknown date , surgery from 1995 to an unknown date , splenectomy from an unknown date and unknown if ongoing , urinary tract infection from an unknown date and unknown if ongoing. Concomitant medication(s) included lamotrigine (LAMOTRIGINE) taken for seizure from 2019 and ongoing; modafinil (MODAFINIL) taken for an unspecified indication, start and stop date were not reported; melatonin (MELATONIN) taken for somnolence from an unspecified start date and ongoing; valproate semisodium (DEPAKOTE) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced urticaria, heparin and experienced drug hypersensitivity, penicillin nos and experienced drug hypersensitivity, sulfamethoxazole and experienced gastrointestinal tract irritation. The patient experienced anaphylaxis (anaphylactic reaction) (medically significant) on 02Jul2021 with outcome of not recovered , had a hard time breathing (dyspnoea) (non-serious) on 02Jul2021 with outcome of not recovered , could not swallow (dysphagia) (non-serious) on 02Jul2021 with outcome of not recovered , weakness on her left side (asthenia) (non-serious) on an unspecified date with outcome of not recovered , her left side and foot feels numb (hypoaesthesia) (non-serious) on an unspecified date with outcome of not recovered , ungodly taste in her mouth, god awful taste in her mouth (taste disorder) (non-serious) on 02Jul2021 with outcome of not recovered , had to monitor her heart because it was off the charts (cardiac disorder) (non-serious) on an unspecified date with outcome of not recovered , felt like her throat was burning down to her chest (burning sensation) (non-serious) on 02Jul2021 with outcome of not recovered , feels like from her foot from the ankle down, is swollen on the left side (peripheral swelling) (non-serious) on an unspecified date with outcome of not recovered. The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of had a hard time breathing (dyspnoea) , had to monitor her heart because it was off the charts (cardiac disorder). Information on the lot/batch number has been requested.

could have had COVID that's why I had severe allergic reaction; could have had COVID that's why I had severe allergic reaction; neck was swollen; felt like the back of her eyeballs were poking/feeling of the eyeball outward/like to the front, like they would pop out of her eye; severe headache; lymphadenopathy/appeared neck was swollen, probably lymph nodes, swollen to the back and side; neck pain feeling of the eye ball outward lasted 1-4 days/severe neck pain; ear burning in ear drums/burning in eardrums, both ears; I thought a severe allergic reaction was like anaphylaxis; little reaction on her left forearm, of a rash; bad flu; This is a spontaneous report from a contactable nurse (patient). This nurse reported different events for different vaccine doses for the same patient. This is one of the two reports. A 62-years-old female patient received dose 2 of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration on 08Jun2021 at 15:00 (Batch/Lot Number: EW1071) single; and dose 1 via an unspecified route of administration on 19May2021 (Batch/Lot Number: EW0183) single, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication from Jun2021 to 09Jun2021. It was reported that with the first Pfizer vaccine dose on 19May2021, she developed chills, had severe headache, feeling of ants crawling in her throat, and shooting pain in the calves and left calf shot down to the big toe, it was shooting pain, but both calves were involved. The patient experienced rash on 08Jun2021; anaphylactic reaction on 09Jun2021; severe headache, 'lymphadenopathy', 'neck pain', 'ear discomfort', 'swelling', 'ocular discomfort' on 09Jun2021 at 15:00; and bad flu in 2021. After what the patient experienced with the first vaccine dose, she was indicated to take Benadryl thirty minutes before the second vaccine. She was however told that it could mask potential side effects. Due to the masking potential, she stopped taking it and reported adverse events. The patient reported lymphadenopathy, headache, neck pain, feeling of the eye ball outward which lasted 1-4 days, and ear burning in ear drums. The patient stated that these (unspecified) stopped on Sunday. Stated that the headache was most severe. Also stated that "I thought a severe allergic reaction was like anaphylaxis". The patient was at another doctor's office and was indicated that she could also have had COVID that's why she had a severe allergic reaction. According to her, she had never been mask less, and was double masking. She works from home. Second vaccination was two weeks post. She could have possibly gotten it, bad flu, that would be the only time she could have. The patient had called on 09Jun2021 as she got her second dose of the Pfizer vaccine on 08Jun2021 and someone was supposed to call her back from the department, whoever handled Adverse Events, but no one ever returned the call or sent an email. She took the first Pfizer vaccine on 19May2021 and had severe headache, feeling of ants crawling in her throat, shooting pain in calves and left calf shot down to the big toe, it was shooting pain, but both calves were involved, and she had spoken to an employee health nurse, who suggested she take a Benadryl 30 minutes before the second vaccine. As they were concerned about the crawling in her throat, they feared anaphylactic reaction to the second, as people said the second was worse, and she called her doctor to confirm, who was also in agreement for her to take it. Her doctor said to take it and take it every 4-6 hours for the first 24 hours, and she had the vaccine on the 8th at around 3PM, and had a little reaction on her left forearm, of a rash. It lasted about 10 minutes and went away. At the vaccine site, they let her go, and she took the Benadryl twice more, her last dose was at 0130. On 09Jun2021, she called Pfizer, who said they don't recommend to take Benadryl, that it could be masking potential side effects that can lead to anaphylaxis, so she stopped taking her last dose at 0130, and at 3PM on the 9th, she had severe headache, neck pain, it appeared her neck was swollen, stated it was probably lymph nodes that were swollen to the back and side, she had burning in her eardrums, both ears, and she felt like the back of her eyeballs were poking, like to the front, like they would pop out of her eye (she thought that was the most predominant symptoms she had). It lasted for 3 days. She spoke to someone on 09Jun2021 in the morning. and stopped taking Benadryl, and they said she would get a call from Pfizer and she thought she would report those side effects after the second dose because they happened in the afternoon, and now she has a day off from work, so she thought to call and say what happened with the second dose. The patient stated that she works from home, but she was not clinical. Confirmed it was the COVID 19 Pfizer vaccine that she received. The severe headache started after 3PM on 09Jun 2021, it was not ongoing and it went away on Sunday, which the reporter provided as "12Jun2021" The patient stated that she has had intermittent headaches ever since, so has recovered with lasting effects, they are not as severe as the original, but she had some lasting effects. The patient was inquiring if she should receive a booster. According to the patient, they were talking about the potential of having to give boosters, and with everything she had been through with the first two (the second was worse than the first), she was ambivalent about getting the booster. Outcome of the event 'rash' was recovered on 08Jun2021; for 'lymphadenopathy', 'swelling', and 'ocular discomfort' was recovered on 10Jun2021; for 'neck pain' and 'ear discomfort' was recovered on 11Jun2021; for 'headache' was recovered with sequela on 12Jun2021; while for the other events was unknown. Seriousness criteria for the severe neck pain was reported as disabling; for the "burning in eardrums, both ears" was not serious; while for the initial headache, to the 12th was severely debilitating, she couldn't do anything, it was horrible, but the lasting effects were tolerable, she took Tylenol and it resolved. For the severe neck pain that ended in the morning and was no longer present (appeared neck was swollen: ended in the evening) seriousness was reported as just mild discomfort, not disabling. For the burning in eardrums that started in the evening, at hour of sleep, at night, was bilateral, burning, inner ear pain, and it was intermittent, and lasted until 11Jun2021, and she went to the ear doctor today, who said her eardrums were ok, but she was concerned, so this was reported as not serious. For the eyeballs poking that happened at the same time as burning eardrums, only at hour of sleep at night, and woke up on the 10th and it was gone, seriousness was reported that since it was intermittent, not disabling, but was annoying. Also stated that it was frightening, but she was worried if it continued, she would go to the eye doctor, but it went away. Causality for the events was reported as follows: severe headache: Yes (Related), severe neck pain: Yes (Related), "appeared neck was swollen, probably lymph nodes, swollen to the back and side": Yes (Related), burning in eardrums, both ears: Yes (Related), and "felt like the back of her eyeballs were poking, like to the front, like they would pop out of her eye": Yes (Related).; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021677809 Same patient, same product, different events/vaccine dose

She got the vaccine on Dec 23, and then on Jan 4 she had a mild stroke with left sided arm and face weakness. She did recover fully. She already has known CAD and risk factors for CVD. It is possible, but by no means certain, that the vaccine was an indirect cause of the event. Since the vaccine provoked an immune response, as it was supposed to, it is possible that this inflammation may have set up a metabolic predisposition that may have contributed to the event, which was 12 days later.

Pounding headache, heart racing to over 145 bps, chest burning and tightness and hard to breath. I was taken to the Emergency Room at Hospital immediately. Reaction occurred within 30 minutes of the injection. An EKG was administered. I was prescribed prednisone and Benadryl. I was diagnosed with Anaphylaxis.

respiratory distress; fever; anxiety developed requiring oxygen; Passed away; This is a spontaneous report via a Pfizer-sponsored program from a non-contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 23Dec2020 at a single dose for COVID-19 immunization. Medical history included anaphylactic reaction (broad), neuroleptic malignant syndrome (broad), anticholinergic syndrome (broad), acute central respiratory depression (broad), hypersensitivity (broad), respiratory failure (narrow), drug reaction with eosinophilia and systemic symptoms (broad), hypoglycaemia (broad), COVID-19 (broad) and chronic obstructive pulmonary disease (COPD); all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium and lorazepam (ATIVAN). Within 24 hours of receiving the vaccine, the patient experienced fever, respiratory distress, and anxiety developed requiring oxygen, morphine and lorazepam (ATIVAN). The patient passed away on the evening of 26Dec2020. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test: negative on an unspecified date. The outcome of the event death was fatal, while of the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Passed a

Left side swelling to include face, arm, hand, trunk, legs and feet. Noted to be +3 pitting edema. On 2/5 @ 1307 start having seizure activity that lasted for over 20 minutes. Per hospital policy code blue was called. This resulted in an ER send out.

Patient had seizure of clonic tonic activity was post-ictal. Non verbal and did not respond to questions.. Transferred to ER via squad.

Pt complained of throat tightness and being lightheaded beginning at 1127 hours (5 minutes after vaccine). She arrived at emergency/symptoms reporting station at 1129 hours. She denied tongue swelling, denied rash, denied difficulty speaking. No rash was seen by medics either. Pt did not have wheezing or stridor. Medics on scene and student medics under the direction of Medics, placed the patient on the monitor. Her HR was stable in the 70s and her sats were 99-100% on room air, with a strong pulse and RR of 16. The pt became more anxious and demanded that someone assist her with her Epi pen administration. RN explained sxs of anxiety and sxs of anaphylaxis. Pt became agitated and again remained adamant that medics give her Epi. At 1132 hours a student medic under the direction of Medics administered the pts own epi pen to her. Vitals signs after epi were HR of 88, BP of 170/97, RR 22, sats 100% . A transport unit was called as precaution and to potentially transport. Pt appeared to have an increase in agitation as indicated by her speech with medics being short and her stating that she was "irritated" with "everyone talking", that she "can't hear everyone all at the same time", that this is just "too much" and waving her hands in the air. Pt was transported to the ER via Medics for continued care and follow up.

Pt received 1st dose of Pfizer Biontech vaccine. Patient reported history of anaphylactic reactions. Pt told to stay 30 minutes for observation. During observation patient reported feeling itchy. VS taken at clinic and were stable: HR 88, BP 135/66 Spo2 94%. Patient's face was slightly red without edema. She reported breathing okay but felt a little tight in her throat. Sent to ER for management. Per ER note "63 year old female with a complex medical history including lupus, scoliosis, Sjorgen's syndrome, and anaphylaxis requiring intubation presents complaining of itching and dizziness following COVID 19 vaccination with the Pfizer mRNA vaccine...patient's exam demonstrates itchy red welts consistent with urticaria and she endorses a foreign body sensation in her throat. Examination of the oropharynx demonstrates uvular edema without stridor. The patient endorses chest tightness but does not have wheeze on exam...endorses nausea. Diagnosed with anaphylactic reaction. Patient received epinephrine 0.3 mg IM, diphenhydramine 50 mg IV, famotidine 20 mg IV, and methylprednisolone 125 mg IV along with albuterol MDI. Had improvement in symptoms within an hour, observed for 6 hours without recurrence of symptoms and was discharged home. Advised not to receive second dose of vaccine until discussion with allergist occurred.

Patient reports having slurred speech beginning 2000 the evening following vaccination. She presented to the ER on 02/11/2021 and admitted to hospital for Acute CVA. Discharged on 02/14/2021. Patient's PCP recommended completion of series.

pulmonary embolism/Blood clots in the lung; heart attack; Shortness of breath; headache; jaw hurt; Shin hurt; heart burn; This is a spontaneous report from a contactable consumer (patient's son). A 63-year-old female patient (mom) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration in arm in Feb2021 (reported as in the first week of Feb2021) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received the first dose of BNT162B2 in Jan2021 for COVID-19 immunization. Reporter (patient's son) received his first dose of Pfizer COVID vaccine on Wednesday and wanted to know if this vaccine could cause blood clot. He stated his mom (patient) in the hospital due to pulmonary embolism from 24Feb2021, 2.5 weeks after her second shot. He stated his anxiety levels were higher than normal. He had strong response to flu vaccine this year and experienced chill, shakes, fever, received antibiotic, and loss sense of taste from the flu vaccine. Reporter read online that some people commented that they have DVTs (deep vein thrombosis) and blood clots from the Pfizer COVID vaccine. Patient experienced blood clots in the lung in Feb2021 and hospitalized on 24Feb2021. Patient got her second shot about 2 weeks before and she ended up in the hospital with pulmonary embolism. They looked at her lungs and found all the blood clots. Patient had really bad shortness of breath, headache, her jaw hurt, and her shin hurt. She was helping out at vaccine clinic and she was out of breath, she said the old people in strollers were passing her. Patient began to make complaints about how she was feeling in mid of Feb2021. Patient said in rare cases 2 weeks after the second dose reactions could happen. Patient got done working in ICU, and helped with PPE, then at 11 she left work at the hospital, she was experiencing heart burn for 3 days and so she thought had a heart attack drove to an ER (emergency room) on the way home, and then was admitted to the hospital on that same day 24Feb2021, she was supposed to be discharged today (26Feb2021). Patient had been feeling out of breath for past 2 month, it was possible it might seem like it was related to the vaccine but it could also not be related. Reporter stated that on the internet he saw how a 1000 deaths happened after the vaccine, it was all old people, but in the autopsies there was no link to the vaccine, they were going to die regardless. Lab data included: She did get a test before for Factor 5 Leiden but it was negative. They did test for COVID, it was negative, while in the hospital. In the hospital they were also testing her again for the Factor 5 Leiden, the results hadn't come back yet. They did test for blood clots, they did an MRI (magnetic resonance imaging) in Feb2021, it was positive for blood clots (blood clots in the lungs). When she was admitted her oxygen was 85%. Outcome of the events was unknown. Information on lot and batch number has been requested.

Developed extensive DVT with pulmonary emboli 4 days after receiving Covid vaccine. Clot was evacuated with thrombectmy but reaccumulated 1 day later, despite being treated with Eliquis.

Pt developed a new onset, acute deep vein thrombosis approximately 6-7 days after vaccination in the R lower extremity with extreme pain and inability to bear weight.

began A-Fib as I was most the way home. It remained for more than 30 minutes, but seems to have subsided at this time of typing.

rash that was all over her body; Extremely red sunburn rash- really bad sunburn, most of it on torso, had it on legs/face was so red like the rough sunburn feeling; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Eyelids red, itchy, and swollen; Felt dizzy and weak/had less energy today; Dizziness and lightheadedness /felt dizzy and weak; Worst and really sharp Charlie horse between ankle and calf- took forever to walk; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Extremely dehydrated, kidneys were showing some damage, creatinine level was really off.; Anaphylaxis due to vaccination; Vomited; Major diarrhea; She was so cold that her toes were purple; Blood Pressure so low: 58, couldn't find a bottom number at first but then at the hospital it was 58/38; Face was extremely pale; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; could not function- she was beyond cold; felt like she was in a bad dream and couldn't wake up, couldn't walk. Feeling like she was getting the flu; Too cold to function or do anything; Nauseated- almost like morning sickness/Extremely nauseated/queasy feeling; Nauseated- almost like morning sickness; very extremely tired; creatinine /it was still high; sick; body temperature was low; She thought she was going to die because of the purple toes; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph.; her body catching up on sleep or she's just tired; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, on 11Mar2021 as single dose in left arm for COVID-19 immunisation. Medical history included ongoing High Blood Pressure (It's under control now, fairly healthy; diagnosed probably when she started menopause in early 50s), ongoing Anxiety (Diagnosed probably when she started menopause in early 50s), ongoing Sinus headache (Worst sinuses; Takes Excedrin because Tylenol does not have an effect on her), ongoing smoker (Pack a day, but smoking about only about half of it each time. started when she was a teenager. She was without a cigarette for 3 days in the hospital, but when she came home she had to start again), menopause (in early 50s), shoulder- torn rotator cuff-operated in 2018. Family history included cardiac and heart disease, Parkinson's and Frontal lobe dementia (husband). Concomitant medication included colecalciferol (VITAMIN D3) 1000 IU, once a day, by mouth (Taken these for as long as she can remember, they kept advising it, husband takes it for Parkinson's so she just throws one in for her), calcium ascorbate (VITAMIN C) 1000 IU, once a day, by mouth (Started at least 2 years ago, doesn't drink enough orange juice, doesn't do fruits, doesn't get enough Vitamin C), linum usitatissimum seed oil (FLAXSEED OIL) 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for cardiac and heart disease, takes as preventative, fish oil 1000 IU, once a day, by mouth (Started at least 2 years ago, family history of cardiac and heart disease, takes as preventative) for family history of cardiac and heart disease, takes as preventative, hydrochlorothiazide, lisinopril 20/12.5 mg, once a day, by mouth (She has been taking this medication for years, under control with this medication) for High Blood Pressure, lansoprazole from 2020 30 mg, once a day, by mouth (Started years ago) for Stomach pill for acid reflux, duloxetine hydrochloride 60 mg, once at bedtime, by mouth (Started forever ago) for just being achy and anxiety, lorazepam .05 mg, 1 tablet 3 times a day, takes one tablet a day at bedtime, by mouth for Anxiety (Started this a while back- with the heart disease and everything else, gave this to help with menopause symptoms too), meloxicam 15 mg, at bedtime as needed from 2017 for back issues- really sore at times, takes if really stressed or she overdoes it. Patient previously took Tylenol for sinus headache and does not have an effect on her. After the first dose of the vaccine the patient reported that she was extremely tired on 11Mar2021. She was completely nauseated most of the day on the second day. On Saturday, she was extremely nauseated (12Mar2021) with vomiting and major diarrhea on 13Mar2021. By 4 PM that afternoon (12Mar2021), she could not function because she was so cold; she felt like she was in a really bad dream and couldn't wake up. She called on 13Mar2021, her blood pressure was so low-they got 58 for the top number, they were unable to pull up bottom number at that point. patient reported that when the ambulance arrived, they described her face as extremely pale on 13Mar2021; her major complaint was that she was so cold- she has never been that cold in her life. When she got to the ER- they had to use the old blood pressure cuff to get her blood pressure because it wasn't coming up on the machine- the kind where you pump it up and watch the needle, they said it was 58/38. patient states that they asked her about the rash that was all over her body in 2021; caller reports that she did not have a rash when she called at 4 PM. patient describes the rash as an extremely red sunburn rash- like you got really bad sunburn, most of it was on her torso, she also had it on legs on 13Mar2021. patient mentioned she remembers them taking off sock and her toes were purple on 13Mar2021. She also had a red on her eyelids- she described as itchy and swollen on 13Mar2021. patient mentions that unbelievably as sick as she was in 2021, she could understand everything that they were telling her. Treatment was given as they prescribed her Prednisone and Benadryl; she was also hooked up to an IV, and they were trying to warm up her body because body temperature was low in 2021. Discharge paper reads as anaphylaxis due to vaccination on 13Mar2021. patient states that she came home from hospital on Monday, 15Mar2021. patient reports she started a diet. 2nd day (12Mar2021)- From the time she got up, she was too cold to do anything; she couldn't walk and she was feeling like she was getting the flu. Saturday (13Mar2021)- She woke up and had the worst Charlie horse between ankle and calf- took forever to walk Charlie horse off. Really sharp Charlie horse. Even had less energy today. Really nauseated. patient reports that yesterday and today, she is just tired. She doesn't know if it's just her body catching up on sleep or she's just tired; she will find out today when she goes to doctor. Caller mentions that she is normally more active than she feels right now. patient reports her eyes have been itchy and she has a rash on her eyelids. patient doesn't know if it's from the shot; patient mentions that she decided on 01Mar2021 she would start a diet, get healthy, and see a nutritionist. patient reports that initially she didn't think her symptoms were from the vaccine and thought it was that she wasn't eating enough food on Friday. She got in touch with the dietitian. patient reiterated she did not attribute this to shot right away. patient reports that she was wondering if she had asymptomatic covid, and it would have been within a 3-month period that she reacted to the shot. She was not sick if she did have asymptomatic covid. There still trying to figure out why her body had this reaction. patient states that every now and then she was still cold, but she doesn't know if its her imagination and plus it is cold outside where she is. She is still on the cuff on that one. patient describes the nausea she first felt as almost felt like morning sickness on 12Mar2021-that's why she attributed it to her diet. patient mentions that the day she started feeling better, late Sunday afternoon, she wanted salty foods. Anything salty, chips, she just really wanted salty stuff. She was not normally a salt person, but the saltier it was, the better it was. patient reports that when she was vomiting with diarrhea and laying down, she would be throwing up in a towel because she couldn't make it to the bathroom when she was laying, it would just gush. patient describes it felt like her body was going to be locked into the position it was in, she doesn't know how to describe it. patient states that she had vomit on her clothes when she called. patient reports the nausea stopped late Monday and the queasy feeling went away. patient reports she stopped vomiting when they gave her Zofran- they had to give her a couple because she didn't stop throwing up right away. patient reports she was extremely dehydrated and her kidneys were showing some damage; her creatinine level was really off on 13Mar2021. The diarrhea was gone, but now she has a mixture of soft stools and semi formed. It is trying to improve but hasn't yet. patient states that because of her creatinine level, they did want her to drink and she might have soft stools because she was drinking so much. patient reports she knows when her husband put the shirt on her she did not have the rash, but when the ambulance arrived, they said she had the rash. Upon discharge, they told her not to receive any further covid vaccines- she cannot get her second one which was scheduled for 01Apr2021. She started experiencing the really cold feeling on 12Mar2021 after receiving the vaccine. She went to bed at 7, that's not like her, she was usually up all hours of the night. symptoms she was experiencing were beyond typical. patient reports she also felt dizzy and weak on 13Mar2021. She thought she was going to die because of the purple toes in 2021- she knew that was a sign of her body shutting down and she got the most scared. patient mentions she is experiencing a residual side effect from the covid and influenza tests-both were negative on 13Mar2021, but it seems like her nose won't stop running ever since she got it, sore from blowing- looks like Rudolph in 2021. patient reports she feels human today, but she is still sleepy in 2021. She thinks she would feel a whole lot better if her nose stopped running. The tiredness might be from nose blowing and stuff. patient remembers the nurse was thrilled that her toes weren't purple anymore. It started going away when her blood pressure and everything came back up. patient states that she was so scared that she was dying so she remembers everything that happened. patient remembers she was in the ER still when her blood pressure improved. Treatment for her face was so red like the rough sunburn feeling and putting moisturizer on the dried cheeks. patient reports that she doesn't see any patches of red on her. Part of her has a fear that the stuff is not totally out of her system and it will happen again. patient mentions she has heard comments that this was not a typical reaction from the first one and wants to know if it is typical to be that sick from the first dose. patient reports that now her eyes just feel like she's allergic to something. She doesn't know if the redness is from crying now- it was improving, but was still there. Husband has Parkinson's and Frontal lobe dementia and she is his caregiver, she cannot afford to get Covid, she wants to get back to normal. patient reports that she did not take any of her prescriptions the day of the vaccine, she did not want to get a reaction. patient reports she had her shoulder- torn rotator cuff-operated on in 2018. If nose is really stuffed up or allergies, or Fluticasone nasal spray- she can take it 2 times a day, 2 squirts in each nostril, take it as needed. patient reports that she has the worst sinuses- when it gets too bad, she'll go to the doctor and she'll prescribe Flonase, take Metamucil or whatever she thinks will help with sinuses. she still wants to get the second vaccine. patient reports her creatinine came down well enough that she could come home from the hospital, it was still high on 15Mar2021 so they told her to drink lots of water so she does not get dehydrated. Patient was hospitalized from 13Mar2021 to 15Mar2021 for Anaphylaxis, Tiredness, Nauseated, Morning sickness, Vomited, Activities of daily living impaired, Walking difficulty, Flu like symptoms, Pale, Photosensitive rash, Asthenia, Dizziness, Charley horse, Dehydration, Renal disorder, Creatinine low, Cold, Diarrhea, Purple toes syndrome, Blood pressure low, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid. For rash also patient was hospitalised. The outcome of Vomited, Pale, Photosensitive rash, Dizziness, Asthenia recovered on 13Mar2021, Nauseated, Morning sickness recovered on 15Mar2021, Activities of daily living impaired, Walking difficulty, Flu like symptoms recovered on 17Mar2021, Diarrhea, Cold, Blood pressure low, Purple toes syndrome, Redness of eyelid, Eyelids itchy sensation of, Swollen eyelid were recovering, Tiredness and Creatinine high were not recovered, while remaining events were unknown. No follow-up attempts are possible. No further information is expected.

Atrial fibrillation. Treated in the hospital with diltiazem fir approximately 4 hours. Sent Home one heart rate was below 100. A Fib resolved approximately two hours later

pain; flu-like symptoms/felt like she had a little bit of the flu; she has one area with a "big circle around it and it's hard; she had a little bit of pneumonia; got a fever; felt like she couldn't go to the bathroom, cramps; had trouble breathing; the site was red; swelling/her arm is swelling; it does hurt her, right in that area where the shot was given; arm was sore and achy/her arm started aching; Diarrhea; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EN6208, expiration date unknown), via an unspecified route of administration, administered in left arm on 22Mar2021 at the age of 63 years old at a single dose for COVID-19 immunisation. Medical history included ongoing pre diabetic, ongoing high blood pressure, ongoing non-alcoholic liver disease, edema, to help her breathe, pneumonia, COVID in 2021, respiratory problems, asthma, little bit of obesity, swelling in her legs, varicose veins. Concomitant medications included benzonatate at 100 mg to help her breathe, azithromycin (six pills of that, 200mg, two one day and one pill a day until gone) for pneumonia. Patient had her second dose scheduled on 12Apr2021. She explained after the shot, her "arm was sore and achy" she said she also had "pain". She added she experienced "flu-like symptoms". She specified these adverse reactions are all gone now but her arm is still "a little sore" and she has one area with a "big circle around it and it's hard". She said it could be "swelling". She asked if her reaction was reported as side effects to the vaccine. She expressed being in a rush and is expecting her daughter soon and asked us to be quick. She said she will also consult with her HCP this afternoon. Patient stated she had the first shot on Monday 22Mar2021 and today and last night the site was red, but today in that area she has gotten a big circle around it and its hard. Patient stated she's had it before with shots and just wanted to make, sometimes she has had to be put on medicine for it, wanted to be sure its healing because it does hurt her, right in that area where the shot was given. She also stated that after she has her second shot on 12Apr2021, she would like to talk to somebody and she would like to be able to have people in her home. She was reporting she had COVID three weeks ago, would she be ok after the 2nd shot to go out? She stated her daughter thinks she needs to wait until the end of April. She verified she did receive the Pfizer BioNtech Covid 19 vaccine. Swelling: Patient stated her arm is swelling. Also stated she always gets that and today there's a circle there and it is red and hard. Also stated occurred after the shot. Patient reported that the shot hurt like heck and she couldn't really tell, she has big arms, she knows it was swollen. Reported she took over the counter medicines, last night she noticed it was a circle and it was hard there. Stated area is not swelling anymore, now just one hard red circle. Red and a hard circle: She also reporting her entire arm ached after the shot, she stated she knows her entire muscle was aching. Stated it was swollen quite a bit but now its just red and a hard circle, and it's ongoing. Arm swelling outcome: Patient reporting yesterday afternoon, she was feeling better, except that one spot. She stated it does hurt when she bends it because she had that one little area that's swollen. Also stated the swelling started later that afternoon after the shot. Reported she went for a walk with her daughter and her arm started aching. It felt like she couldn't go to the bathroom, cramps. It felt like she had a little bit of the flu, and it was from the shot but it only lasted a few days. Stated that part went fast, got a fever, other than that, just the one area on her arm. Stated she doesn't even feel sick from the shot or anything. Stated she had Diarrhea: Stated she had diarrhea in the beginning after the shot then had trouble going to the bathroom. Stated she thinks its because she has IBS and that's how her body is. She doesn't know if that's from the shot or not because that's how her body always is. Pfizer BioNtech Covid 19 Vaccine: Patient stated she doesn't want COVID again. She has respiratory problems anyway, she has asthma and a little bit of obesity. She states she was in fear of herself. She doesn't do well with hospitals and being put under with that medicine. Also stated patient knew COVID causes a lot of people having trouble breathing and she doesn't want to end up on a breathing tube where its breathing for her and she never sees her family again. Caller states it kind of scared her. Patient stated her niece and nephew, whos got it worse. She stated she went to the hospital and haven't been back. She stated she was hospitalized about 2 weeks ago, and that's when she was diagnosed with COVID, before she got the first COVID shot. About the medical history, non-alcoholic liver disease: Stated diagnosed about eight years ago, she would say the same time, about 7 to 8 years ago because she had a virus and when she went in the hospital, the virus had attacked her right kidney and liver. She stated with non-alcoholic liver disease, she is overweight, and that causes her to have issues with her liver. The last few times her liver has been okay. Pre-Diabetic: They have been watching that for a while. Stated she gets edema, swelling in her legs, well, all the time. She has had this the last two years because she is pre-diabetic and a lot of overweight people have that. She also has varicose veins so that doesn't help. Stated that was given those to help break up, because she had pneumonia when she got the COVID and she had a little bit of pneumonia and had trouble breathing. The patient was recovering from arm was sore and achy/her arm started aching, swelling/her arm is swelling and for other events it was recovering.

Patient got an instant reaction after receieving the vaccine. She had an anaphylactic reaction, she stated throat swelled up and couldn't breathe, BP was elevated and she started to experience hot flashes. Pain at the injection site. Patient took a benadryl and about 20 minutes later the symptoms started to subside. No c/o fever, headache, n/v. As of 4/8/21 @12pm patient is not experiencing any symptoms only slight pain at the injection site. No medications were taken as far as Tylenol/Ibuprofen. 4/11-Follow up call -Patient feeling better but is apprehensive taking second vaccination due to anaphylactic reaction from first vaccination, even though she is aware that it is not recommended. No signs and symptoms at this time.

12 hours after receiving 2nd vaccine (4-5-21) I started throwing up through Tuesday 4-6-21. Then on 4-7-21, my left leg calf was very sore and hard for me to walk, Got worse, so on 4-9-21 went into Urgent care and through a vascular ultra sound determined I had a very Large blood clot in my calf. (ACUTE THROMBOSIS OF THE LEFT PROXIMAL PERONEAL VEIN)

Blood clot in leg. Began as pain and skin discoloration in leg, eventually went to emergency room on 07Apr2021 and diagnosed with ultrasound. Treated with Xarelto, ongoing. Acute right lower extremity superficial thrombophlebitis noted in the greater saphenous (above knee). This superficial thrombophlebitis extends more than 10 cm in length. It does not extend into the deep system but is about 1.3 cm from the origin of the common femoral vein.

On 04/04/2021 after having memory issues I went to the emergency room and was diagnosed as having 3 strokes. I woke up with a throbbing headache and then had difficultly remembering simple things like using the remote control for TV. My vision was also somewhat blurry. I then went to drive and my focus was off making driving difficult so I then went to the emergency room

2/28/21 Four days after 1st Pfizer vaccine 2/24/21 Severe cramping and swelling in my right leg and ankle. 3/9/21 Work clinic advised to seek medical attention 3/9/21 Hospital Emergency Room Diagnosis: Deep Vein Thrombosis (DVT)- Blood Clot 3/10/21 Thrombectomy Surgery & Released 3/11/21 Swelling in right leg and ankle Returned 3/12-16/21 Readmitted - Blood Clot returned Currently under several doctors care.

Thrombocytopenia AKI (acute kidney injury) Neutropenic fever C. difficile colitis Hypotension, unspecified hypotension type Sepsis

has possible atrial fibrillation; Arm would get hurt; her arm felt like a bruise; irregular heart rates; She'll have a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night.; When probing for specific event information she reports it's kind of like she coughs a little more and she is a little more short of breath and it's happening more often; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 63 years, via an unspecified route of administration on 27Mar2021 04:06 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history included asthma, hysterectomy, dark chocolate or red dye (she starts coughing and has an allergic reaction and shortness of breath), bursitis (in her right). The patient's concomitant medications were not reported. The patient previously took penicillin, experienced allergy and had really ad hives (several years ago) she was given a cream to put on. She had to get another medication and she doesn't remember the name. That medication made her dizzy and she couldn't even get out of bed so they had to half the dosage. When she had her hysterectomy she learned she couldn't take any types of "cillins" medications. The patient had been watching her heart rate with a device and since getting the Covid 19 vaccine she's noticed her heartrate was always higher than it normally is. Her heartrate was going crazy, the device was not recording right. She reports that for the last 2 days the device has been telling her she has possible atrial fibrillation. This is worrying her. She doesn't feel anything different. She was usually hyper. Her resting heartrate was higher. Normally her resting heartrate was in the 80s (beats per minute) Now it's going up to the 90s (beats per minute) then her heartrate drops to 40 something (beats per minute) Then the device said her heartrate was 118 and 107 and she's not even doing anything. She hasn't even worked out yet. She doesn't like to take medicine. Medications don't work out with her. She had a slight cough and she feels a little short of breath then she's fine. That happened leaving the Covid 19 vaccine site. And it's been happening more at night. It was reported that she feels fine. She has no other symptoms. She's been reporting online. Clarified she's reporting online through the V check through the CDC. She's been trying to get the Covid 19 vaccine forever. She did research on all the Covid vaccines and she felt more confident with the Pfizer Covid 19 vaccine. Her daughter was against the Covid 19 vaccine. Her daughter thinks the vaccine was just going to kill her. She reports she was healthy and she works out 6 days a week. She recently tried to get a CT scan for her heart. Her husband's cardiologist recommended her husband have a CT scan of his heart and she decided she needed a CT scan too. She's also watching her heartrate on her watch. Her husband's heartrate is completely normal and stable on the device so she knows the device isn't messed up. It was also reported that the device will tell her she has too much muscle movement and she's standing completely still. Then she'll get the device to record her heart rhythm and it goes sporadic. The device tells her 90 beats per minute at resting then over 100 beats per minute. Her heartrate on the device was going up and down a lot. When she's been watching the device record her heart, it looks like it's going crazy. Her heartrate goes way up and way down like in the 40s (beats per minute) She noticed when her heartrate is in the 40s (beats per minute) and she's never had her heartrate go down that far, it's really really weird. She thinks maybe she'll get back to normal. She keeps watching hear heartrate. She reports she noticed her heartrate right away on Saturday evening after she received the Covid 19 vaccine. Her heartrate was higher than normal for resting, it was in the 90s (beats per minute). Her resting heartrate is usually in the 60-80s (beats per minute) and it was the in 90s. Now the device says possible atrial fibrillation. It was further reported that she received the Covid 19 vaccine in her left arm because she has bursitis in her right. If she hit her arm the second day after the Covid 19 vaccine, her arm would hurt. Her arm felt better the next day. She clarifies, on Sunday, 28Mar2021, she noticed her arm felt like a bruise and that was it. Then the next day on Monday, 29Mar2021, the feeling was gone. She didn't have any redness. The outcome of the events her arm felt like a bruise and arm would get hurt was recovered on 29Mar2021, irregular heart rates, dyspnea, cough was not recovered and unknown outcome for has possible atrial fibrillation. Information on the lot/batch number has been requested.

developed blood clots in lungs; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: CP6955), via an unspecified route of administration into the left arm on 17Mar2021 as a single dose for COVID-19 immunisation. Medical history included allergies to sulfa. Patient was not pregnant. There were no concomitant medications. The patient previously took amoxicillin and experienced drug allergy. The patient developed blood clots in lungs on 27Mar2021 09:45. The patient was brought to the emergency room and was hospitalized for 3 days. The event was reported as life threatening. It was also reported that the patient was given treatment (unspecified). The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 27Mar2021. Outcome of event was recovering.

Reporting Per EUA Covid 19 positive, admitted to hospital, transferred to higher level of care after 3 days for respiratory failure

Suffered 2 major/large strokes in her occipital lobes and small temporal stroke She is now blind, unable to walk, sit, stand, eat by herself, and has speech issues. She is needing full care at this time and unknown what future holds She has been in ICU since 4/17 as we found her unconscious 4/17-she was down by herself tor over 24 hours

Also felt that she almost faint, not dizzy not vertigo type for under a minute; stroke; meningitis; have massive diarrhea; had a sore throat and could not swallow or eat; menstrual cramps; felt alot of extreme fatigue; felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it; sinus pain; her face and eyebrows hurt; throw up viscously that it is almost coming out of her nose and also went to sheer panic/vomiting; she is not speaking well or understood well; profusely sweating and had whole body sweat drenched on the floor; ice-cold ends; painful arm; baseline temperature is 94.6; Neck pain; Woke up Monday morning and couldn't get out of bed, wanted to die; Caller states she is losing her mind; had her gripping her pelvis because of the pain; sheer panic.; woke up with gut ripping food poisoning; still very tired; couldn't get out of bed; had a sore throat and could not swallow or eat; feel nauseous; feeling dehydrated; her head because of the ache; getting sick; nausea; experienced severe headache which led her to stay in bed all afternoon/her headache is more severe and describe it as she would like to shot her head because of the ache; has a flu-like chills; body ache symptom which comes and go; This is a spontaneous report from a contactable consumer. A 63-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP7534) via an unspecified route of administration in arm left on 21Mar2021 as single dose for covid-19 immunisation. Medical history included taking a anti-HTN medicine (beta blocker) and had slowly been weaned off of that prior to getting his shot as her cardiologist is afraid that it might affect the efficacy of the vaccine shot and had not been put back in any BP regulating meds until then and quite concerned because of her fluctuation BP. anxiety and gets to panic immediately, also is disabled and doesn't live with any nearby family, has allergies to alot of foods. State she comes from family of strokes, heart attacks, and high blood pressure and one of her biggest fears is having a stroke. States her boyfriend has a family of strokes too, 2 blood pressure medicines, which contain polyethylene glycol (PEG). and concomitant medications not reported. The patient stated after 1 week of getting the vaccine- getting sick, felt alot of extreme fatigue, felt hands to be freezing for 4-5 days and she have to get hot water to wrap around it. On 03Apr2021 experienced severe headache which led her to stay in bed all afternoon, she also has a flu-like chills body ache symptom which comes and go. On 04Apr2021 experienced nausea and took Tylenol for feeling so sick and felt well 2 hrs after. On 05Apr2021 woke up feeling all the symptoms like the other days, her headache is more severe and describe it as she would like to shot her head because of the ache, she also had a sore throat and could not swallow or eat for 2 1/2 days, she also feel nauseous and throws up water already, she already was feeling dehydrated. After which she called her doctor and mentioned that no organization or her doctor cant guide her well with regards the symptoms that she is feeling if this is common after receiving the vaccine. She asked her doctor and her doctor said that it could probably be a symptom of COVID19 infection. So she got tested and turned out she had a negative result. After a while she also experienced some sinus pain that was not normal for her, she also mentioned that her face and eyebrows hurt. She went to her ENT and ENT who she trusted and respected a lot as a surgeon because according to her is very well versed mentioned that these are not normal side effects that she is experiencing. She also consulted with a brain surgeon and the brain surgeon mentioned that if the side effects won't go away , advised that she need to go to an ER and that doctor feared that he could be having stroke or meningitis. In shock, patient called her cardiologist again and cardiologist advised her not to be alarmed about brain surgeon's advised. She was back to her BP management medication for 2 days already and cardio advised that she should get the vaccine still. On Wednesday and Thursday- her sinus pain went away she had experienced the worst pain ever and had her gripping her pelvis because of the pain, she also have massive diarrhea, had nausea and throw up viscously that it is almost coming out of her nose and also went to sheer panic. Also felt that she almost faint, not dizzy not vertigo type for under a minute. Called her neighbor and neighbor said that she is not speaking well or understood well. She was profusely sweating and had whole body sweat drenched on the floor. Called her physician and physician said that it could be food poisoning. Patient even said that she is not blaming the above event with Pfizer. Also mentioned she experienced sore throat in between. Patient states she is losing her mind, she is a highly anxious and panicky person, she was worried about getting the vaccine at first, but went ahead with it. States she has removed herself from her blood pressure medication, Bystolic, because there is an ingredient in there that is a beta blocker, polyethylene glycol or polysorbate or something. Worried of having an anaphylactic reaction now after the vaccine to the medication, states she has allergies to alot of foods. Patient states she had a very painful arm at first, that she had no symptoms for the first four days, states a week later she started getting sick, states last Saturday symptoms worsened significantly, that she had a headache and it wouldn't go away for 4-5 days, nausea, vomiting a couple of days, dehydration, a little diarrhea, chills, mild body aches. One day she was down for the count, then on Easter Sunday she took a Tylenol and was better. Later in the afternoon the nausea came back. Woke up Monday morning and couldn't get out of bed, wanted to die. States her baseline temperature is 94.6 and she went all the way up to 98 it was rising, body aches, sore throat. Went and got tested for Covid, flu, and strep and were all negative at urgent care. There the doctor told her because of her neck pain that she says she has had for years, she could die of a stroke or meningitis and so she called her ENT and they told her to wait a couple days and then to go to the emergency room if she was not better and the headache does not go away soon. patient states she does feel better today, only last night she woke up with gut ripping food poisoning, like she had the flu, Had worst menstrual cramps in that area, then she was throwing up, had diarrhea, felt like she was going to faint, went into this ungodly sweat. Saw on news that more people are getting sick a week or more after the shot, did not mention which shot they received. States she has a previous disability and a broken foot. Today she is feeling fine, just still very tired. experienced side effects between 1-1.5 weeks after the injection. She listed the following symptoms: headaches, chills, nausea, a sore throat, fatigue, ice-cold ends, vomiting, and diarrhea. She specified her sore throat was from hell, her temperature was up, but she had no fever, and both the vomiting and diarrhea were little. She added last Saturday was when she felt sick the most and it lasted 4-5 days. She said she tested for COVID-19 and the Flu. She specified the doctors also thought she had a stroke then meningitis. She explained she spoke with 3 doctors but feels like she's on her own to determine whether she should get the second dose. The patient underwent lab tests and procedures which included body temperature: up, body temperature: 94.6, body temperature: 98, influenza: negative, sars-cov-2 test: negative, streptococcus test: negative. Seriousness was non-serious. The outcome of the events was unknown.

Started having left leg pain and swelling 2wks after 1st covid vaccine (3/12/2021) at outside facility. Seen on 4/6/2021 (same day as 2nd vaccine). Dx with acute DVT of Left popliteal vein with extension into left peroneal veins of calf. Denies HRT, smoking, prolonged travel, surgery

Same day mild symptoms of pain at injection site, numbness on tongue and facial area; Day 2 symptoms mild fatigue, muscle pain in extremities and headache; Day 3 symptoms more severe headache and fatigue; Day 4 symptoms dry cough and neck pain; Day 5 feverish, neck pain, cough, shortness of breath, night sweats; Day 6 worsening cough and shortness of breath...went to urgent care facility; Took Tylenol each day but little to no relief

Patient had Second Pfizer dose on 3/30/21 and on 4/26/21 was diagnosed with a right leg DVT. She is undergoing hereditary hypercoagulation evaluation. She is otherwise up to date on her cancer screenings. No other provoking factors.

Stroke; MRI showed Pontine Stroke; left arm was weak; her writing looked like a baby's scribble/she cannot write or type; arm was sore; she sounded different; they said her speech sounded slurred; was prediabetic before her hospitalization with her number (A1c) usually being 6.5-6.8. She added that when she was in the hospital it was 7.4; was not able to walk at first; her arm was cold; This is a spontaneous report from a contactable consumer (patient) reported that a 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198), via an unspecified route of administration on 24Feb2021 08:00 (at the age of 63-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included high blood pressure that was diagnosed 2-3 years ago, diabetes; she was prediabetic, heart;cholesterol has been high for about 30 years; since she was in her 30s; all from an unknown date and ongoing. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) on 02Feb2021 (at the age of 63-years-old) for covid-19 immunization. The patient had no prior vaccination in four weeks. Concomitant medications included rosuvastatin taken for blood cholesterol and takes 20mg once a day prior to stroke and in the hospital they increased it to 40mg once a day and ongoing; ramipril taken for blood pressure and she was prescribed with this medication for a while prior to her stroke. It was discontinued in the hospital. Stated that she did not take it everyday because she was allergic to it; and sitagliptin (JANUVIA [SITAGLIPTIN]) taken for diabetes from an unspecified start date and ongoing and stated that she has been taking for quite a while. On 24Feb2021 she had her second shot. She said that everything was fine that morning; that afternoon her arm was sore. Stated she thought nothing of it. That evening she entertained guest. They were saying she sounded different; they said her speech sounded slurred. She had gotten her vaccine at around 08:00. Again, she didn't think anything about her speech. On 25Feb2021, she got up and did some laundry going up and down the steps. Stated that it was difficult because her arm was still sore. She cleaned the house. At around 15:30 she was doing bills and noticed that her writing looked like a baby's scribble. On 26Feb2021, she noticed that her left arm was weak and was told by her doctor to go to the Emergency Room where they told her she had a stroke. She added that it seemed like her arm was cold for a number of weeks. Stated she was the type to wear t-shirts in the winter because she was always hot. During those weeks she was wearing heavy clothes and was under blankets. She was just now starting to feel more like herself and not so cold all the time. The patient was unable to recall time frame when this symptom began. The events did require a visit to emergency room and physician office. The patient was hospitalized for 4 days due to the events from 26Feb2021 to 01Mar2021. During hospitalization, the patient saw a cardiologist, neurologist, her primary care provider, and the hospitalists who all said it was very suspicious that her stroke happened right after her vaccine. Before she got her second vaccine, she was doing embroidery and everything she normally does; nothing was wrong. They did a CAT Scan that showed nothing. Then the MRI of the brain showed a Pontine Stroke on 26Feb2021. Cardiologist put a heart monitor on her and could not find anything. They were looking for A-Fib or something like that when she was on the heart monitor in the hospital; but it never showed anything irregular. She had a loop recorder implanted to monitor her heart and they haven't found anything wrong on it. She had heart tests, carotid artery tests, ultrasound of her heart and nothing was found on those tests. They pretty much told her in the hospital that they couldn't find a reason for her stroke. She kept asking about the vaccine. They did not rule it out as a cause, but they also did not say it was the cause. All the doctors said they could not pin her stroke on the vaccine. They stated it was suspicious and that they had seen 2-3 other patients with a similar situation. One of the doctor's told her he would not rule it out. They did an ultrasound of her carotids and heart and did not find anything on those tests that would have caused her stroke. She was having lasting effects related to her stroke. Her arm was still sore at times, stated it was a different kind of sore and could be related to all the therapy she does now. The lingering effects after stroke was reported as she was not able to walk at first. She's been doing therapy focused on her left side. Stated that her left side was the dominant side and she cannot write or type. She couldn't do the report online due to the difficulty with typing. She wanted to make sure this was reported. The patient has been doing therapy for 7 weeks, twice a day; and stated she likely still has months more of therapy to try and get her left side back to normal. She said that simple daily duties are difficult. The patient also stated that she was prediabetic before her hospitalization with her number (A1c) usually being 6.5-6.8. She added that when she was in the hospital it was 7.4. She doesn't know what made it go up. Then states she doesn't know if the vaccine made it go up or not. She has a follow up with the neurologist soon. The patient also reported medications she has been taking since her stroke and hospitalization; but not prior to her vaccine which included Amlodipine-Benazepril: 5-20mg once a day and Aspirin: 325mg once a day. The patient stated that stroke and heart problems do not run in her family. The outcome of the events was unknown.

Patient experienced progressive facial palsy and ophthalmoplegia, respiratory failure requiring intubation. possible diagnosis of Guillain-Barre syndrome, likely Miller-Fisher +/- Bickerstaff variant. Still in hospital

Patient had 3 different clots in her left leg and a small-moderate PE for the first time ever, 2 weeks after #2 Pfizer vaccine.

4/27/21 started having scant/light vaginal bleeding dark in color that persisted through that day resolving. Spoke with her liver specialist who ordered CBC, PLT which was interpreted by MD Liver as normal. Follow up with gyn

Severe sepsis secondary to Covid pneumonia: Patient made nice recovery with the completion of convalescent plasma and remdesivir. Patient will complete 5 more days of oral dexamethasone.

Ongoing Left wrist pain and swelling with axillary lymph node enlargement a couple of days following the vaccine admin. Xarelto 15mg take as directed Xarelto 20mg take as directed

incredibly horrible itching under her Fitbit; whelp; her lips had started swelling; her tongue was tingling; she thinks that it was the beginning of anaphylactic reaction; she was just tired; type 1 hypersensitivity; a little soreness; It was like heaviness on her chest; having trouble breathing; allergic contact dermatitis; This is a spontaneous report from a contactable consumer (patient) and a physician. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 14Apr2021 10:00 (lot number: EP7533) as SINGLE DOSE for COVID-19 immunization. Medical history included ongoing nickel allergy for decades which was under control and panic attacks. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 14Apr2021, it was reported that the patient didn't have any of the normal side effects such as fevers or chills but she was just tired and went to sleep early that night. She woke up on 15Apr2021 at 05:00 with incredibly horrible itching under her Fitbit that she wears to bed. She has a history of nickel allergy and she bought this particular Fitbit on purpose because it doesn't have any nickel in it that touches her skin and she has had no problems all year with the Fitbit. The itching was unbelievably bad and when she took the Fitbit off she had a horrible whelp under a tiny piece of metal that isn't even supposed to touch her skin. She thought well if it has exacerbated her nickel allergy then maybe it is doing something else to her body. On that day (15Apr2021), she thought that she had a panic attack and upon reading some information online, she thinks that it was the beginning of anaphylactic reaction because the symptoms are the same. She was thinking that the vaccine is doing something with her nickel allergy. It had used to be bad until she got it under control and she had it under control for many years. But with the things under the Fitbit she was blaming or associating it with the COVID vaccine so she took it off and then finally fell asleep again. But when she woke up in the morning, just a few hours later (15Apr2021), the bad whelp was still there and then her lips had started swelling and her tongue was tingling so she decided to look some more on google and she thinks that this is another version to an allergic reaction. She has had panic attacks before and she knows what they are now and she has learned through a therapist on how to get past and manage them but this was different for her. It was like heaviness on her chest and it felt like something was on top of her chest and she was having trouble breathing; both on an unspecified date in 2021. Her husband knows when she has a panic attack but this one was different she can't really explain it. She asks, what is the difference between a panic attack breathing and this type of breathing and later mentioned that she also had a little soreness (2021). In addition, the physician also called to report that this patient was complaining about 2 types of symptoms. The first was more an allergic contact dermatitis (2021) which the physician is not worried about. The second was lip swelling and tongue tingling which could be a type 1 hypersensitivity (2021). The physician is more concerned about the latter and would like to know if it is okay to pre-medicate the patient with Benadryl before getting the second dose. The outcome of the event 'she was just tired' was recovered on 14Apr2021; incredibly horrible itching under her Fitbit; whelp was recovering; her lips had started swelling and her tongue was tingling was recovered on 15Apr2021. The outcome of the other events was unknown.

DVT; tingling feeling on my right leg; leg was severely black and blue/black and blue on my right shoulder; very warm; swelling rapidly; sever left arm pain; nausea; Floating Bruising; Charlie horses on right leg calf; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Jan2021 (Batch/Lot Number: EL 3249) as SINGLE DOSE for covid-19 immunisation, at 63 years old. Medical history included caesarean section from 1988, and allergy to animal (Cat and Dog dander) from an unknown date. Patient received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 30Dec2020 17:00 (Batch/Lot Number: EK9231) as SINGLE DOSE for covid-19 immunisation. There were no concomitant medications. The patient previously took tramadol and experienced drug hypersensitivity (allergies). On 08Apr2021, while patient was reclining in her chair, she felt a tingling feeling on her right leg. She pulled up her pants leg and found her leg was severely black and blue, very warm and swelling rapidly. She went to the ER they did a CT scan and Chest Xray (Apr2021). The ER Doctors (mostly Medical Students at a Teaching Hospital) suspected she had a DVT. Patient was also experiencing severe left arm pain, left hand tingling and severe nausea. They said patient was fine on all accounts and told to get rays of her right leg and for her to follow up with her primary Doctor who is an NP with Hospital. After doing everything as instructed by all the Physicians, 16 days of the bruising and ER visit, patient is still experiencing "Floating Bruising" appearing on her right leg, right ankles and Charlie horses on right leg calf. Today patient now have black and blue on her right shoulder. Patient commented "Someone help me please. This is scary". Events occurred on 08Apr2021 17:00. Treatment was received for the events and required emergency room and physician office visit. Outcome of the events was not recovered.

3-4 weeks after the 2nd dose experienced intermittent atrial fibrillation for over 3 weeks, then developed hyper tension of 180/80-100. Currently on 2 BP meds, that is not controlling the pressure; hyper tension of 180/80-100. Currently on 2 BP meds, that is not controlling the pressure; This is a spontaneous report received from a contactable nurse (patient). A 63-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 01Mar2021 15:00 (Batch/Lot Number: EN6200) as 2ND DOSE, SINGLE for covid-19 immunisation. No pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Other. Medical history included Hypothyroid. No known drug allergies. Concomitant medication included thyroid (ARMOUR THYROID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included BNT162B2 for COVID-19 Immunization [{product=COVID 19, brand=Pfizer, lot_number=EL9262, lot_unknown=False, administration_date=08FEB2021, administration_time=03:00 PM, vaccine_location=Right arm, dose_number=1}. Prior to vaccination, the patient was not diagnosed with COVID-19. Adverse_event was reported as 3-4 weeks after the 2nd dose experienced intermittent atrial fibrillation for over 3 weeks, then developed hyper tension of 180/80-100. Currently on 2 BP meds, that is not controlling the pressure. Adverse event start date: 29MAR2021, adverse event start time: 07:30 PM. Event treatment included telemetry monitor and 2 High BP Meds. Events resulted in: Doctor or other healthcare professional office/clinic visit. Event outcome was not recovered. The case was reported as Serious: No. Since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Atrial fibrillation,uncontrolled hypertension. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate

a blot clot discovered in lung within 2 weeks of first shot.; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number En6202, on 28Feb2021 10:45 at single dose in right arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no known allergies. The patient had no covid prior vaccination. The patient had not tested covid post vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had a blot clot discovered in lung within 2 weeks of first shot on 11Mar2021. The event resulted in Physician Office Visit. Treatment included blood thinner for blood clot. The outcome of the event was unknown. The event is serious with hospitalization and disability. Follow-up attempts are needed. Further information is expected.

Suffered mini stoke approximately 20 days after vaccine and a stroke 21 days after vaccine.; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 22Mar2021 09:30 (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunisation. Medical history included Covid-19 from Jul2020 (prior Covid 19 in July of 2020 with longhaul issues) and allergy to compazine and meperghan. Concomitant medications included gabapentin, rosuvastatin, colecalciferol and ubidecarenone (CO-Q10+VITAMIN D3). On 10Apr2021, the patient suffered mini stoke approximately 20 days after vaccine and a stroke 21 days after vaccine. The patient was released from urgent care on 10Apr2021 and went back 11Apr2021 after apparently having the stroke during morning hours of 11Apr2021. Transported around midnight of the 11th to hospital. The patient was hospitalized for four days and received Plavix and aspirin. The outcome of the event was recovering. Information on the lot/batch number has been requested.

She did not have control of her bowels when sneezed or coughing. She complained of trouble breathing and in a lot of pain. She passed away on April 3 with pneumonia

1st vaccine made me a little sick. 2 days after 2nd vaccine given on 4/22/2021 I started getting sick and kept getting sicker & sicker. I ended up with double pneumonia and 105.1 degree fever. I was so sick I ?lost days? and don?t remember them. After 3 dr. Visits, 2 puffers and two rounds of antibiotics I?m very, very weak and still coughing but better. I was told by the pharmacist to report this because they had numerous people came down with double pneumonia and a high fever just like I did and NOT TO TAKE THE VACCINE AGAIN!

D Dimer was high; Chest tightness; blood clots in the lungs; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 10:30 (Lot Number: ER2613) as SINGLE DOSE for covid-19 immunization. Medical history included ongoing retinal tear from an unknown date (long ago, maybe 2005), Blood pressure, anxiety, reflux, irritable bowel syndrome, eye care. Three years ago, patient had a blood clot on the portal vein. She was treated with Eliquis, referring to Apixaban, for six months. Then they went into the D Dimer and found out she only had one gene for the blood clots, so they discontinued Eliquis, referring to Apixaban. The doctor said the protocol didn't call for it because she only had one gene. Eliquis, referring to Apixaban, was discontinued a year and half ago. The reporter mentioned the specifically didn't get the Johnson and Johnson shot due to blood clots. Family History included that her mother and sister had blood clots in the past unrelated to the vaccine, anxiety which her mom has. Concomitant medications included ramipril taken for blood pressure from an unspecified start date (for five to ten years) and ongoing; ongoing omeprazole taken for reflux; fluoxetine taken for anxiety (for what her mom has) taking for three years and ongoing; linaclotide (LINZESS) taken for irritable bowel syndrome taking for 3 year and ongoing; magnesium sulfate taken for eye care taking for 3 year and ongoing; latanoprost taken for retinal tear from 2005 and ongoing. Prior Vaccinations (within 4 weeks) was none. The patient previously received the first dose of the Pfizer COVID 19 vaccine on 26MAR2021 at 1000AM in the right upper arm (Lot number for first dose is ER8732; expiration date 31Jul2021). Last Wednesday she started to have tightness in her chest so they called an ambulance. She was admitted to the hospital 28Apr2021 and was discharged Saturday 01May2021. In the hospital they did a CT and it came out that she had bilateral blood clots in the lungs; the doctor said it was a shower of blood clots in the lungs, small enough not to occlude anything. They treated with a 72 hour heparin drip. They didn't do any more CT but they did put her on Eliquis, referring to Apixaban, for the rest of her life. For the Eliquis he mentioned the generic Apixaban; unknown manufacturer; caller did not see NDC, lot, or expiration date on product dispensed in a pharmacy vial. Last time she was also on the Apixaban, not the brand Eliquis but they have discarded all the old product. The patient also did an X Ray; EKG (Electrocardiogram) was normal sinus; all the blood work including the CBC (Full blood count) was normal on an unknown date; her D Dimer was high on 01May2021. The events required a visit to Emergency Room. The outcome of the event chest pain was recovered with sequelae, of blood clots in the lungs was not recovered, of other events was unknown. Batch/Lot number had been obtained. Further information has been requested

Left lower leg DVT- occlusion of the posterior popliteal vein; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021 (Batch/Lot Number: EW0172) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at event onset and at vaccination. The patient previously received the first dose of bnt162b2 (lot number: EW0150) on an unspecified date in left arm for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced left lower leg DVT- occlusion of the posterior popliteal vein on 06May2021 at 08:00. The event resulted in emergency room visit. The patient received treatment for the event with Xarelto 20 mg daily for at least 3 months. The outcome of the event was unknown. Follow up attempts needed. Further information is expected.

The patient reports she had progressive shortness of breath for the past month, after she received her second dose of COVID vaccine. She presented to hospital on 5/22/21 with pulmonary embolism.

9:25 tongue had slight reaction, funny taste 10:23Anaphylaxis, took homeopathic Antihistimine, and Benadryl 25mg , Throat & Tongue swelling, funny chemical taste more intense. Tired all day, and pain at injection site. Day #2 Body aches, tired Day #3 Flu like symptoms Day #4 Flu like symptoms and SOB Chemical Taste more intense Day #5 Tongue Throat swelling all week, Benadryl all week. PM Start Prednisone … Day #6 Throat better on the L side. Day #8 Tongue swollen & Chemical taste, throat esp on R, PM go to ER. shakey. Day#8-Day#14 Dry cough, more SOB, same symptoms, continue Prednisone Day #15 Saw Pulmonologist, hot w/ head rush, productive cough for 2wks; Day # 42 Not good, call for current status

Initially presented to emergent care on 4/8/21 for left arm pain, SOB on exertion, and intractable headache. Headache had been ongoing for 12 days. It was throbbing and in the frontal region with nausea. No phonophobia. No weakness. No vision loss. No speech impediment. She was somewhat less active given her severe headache. She was found to have a DVT in the left arm and bilateral PE with heart strain. Referred to Hospital and admitted. Started on lovenox 1 mg/kg every 12 hrs and elected to be transition to coumadin since her sister had another blood clot on Eliquis. Neurology started her on gabapentin. She was discharged and told to follow-up with hematology and warfarin clinic. Presented to the ER on 4/27/21 with SOB at night that had been worsening the past 2 nights. Denied dyspnea or chest pain. Sx were thought to be due to anxiety given her hx of panic attacks. She was discharged home and saw hematology the following day. Hematologist noted that her SOB was gradually improving and her left arm swelling and vascular changes had resolved. Repeat CT showed improvement in clotting burden and stable pulmonary and hepatic nodules.

H&P: Patient is a 63 y.o. female who presents for chest pain found to have NSTEMI. No prior cardiac history who presents with acute onset left sided arm, and jaw pain. Associated with diaphoresis. Looked up "heart attack signs in women" and came to the ER after reading this. In the days/weeks leading up denies any chest pain or pressure, LH, dizziness or syncope. No exertional dyspnea, orthopnea, PND or LE edema. BP at home are usually 130-150s. BP in the hospital is always higher because of white coat hypertension. ER course BP 170-190s systolic, HR in the 90s, AF. EKG Q waves in the inferior lead with no significant ischemia or ST elevations. Labs notable for a troponin ~ 2000. CXR within normal limits. Given aspirin, statin, nitro and heparin. Currently feels pain free. No other acute issues or complaints/ Smoked 3 mos after a divorce, otherwise no smoking history. No significant family history of CAD. " D/C summary: "Principal Diagnosis: o Myocarditis Secondary Diagnoses: o Type II MI o Hypertension o Hypercholesterolemia o Prediabetes mellitus o Obesity Procedures/Diagnostics: 5/13/2021. Coronary angiogram. o Normal left ventricular function o Normal coronary anatomy o Right radial loop Note: A right radial loop was encountered requiring a femoral access. 5/13/2021. Echocardiogram. ? Left ventricle size is normal. Mildly increased wall thickness. Normal wall motion. Normal systolic function. LV EF is 75 % , ? Nrrmal valve function. 5/13/2021. Cardiac MRI. Evidence of myocarditis, with subepicardial late enhancement at the mid chamber and apical lateral wall with associated regional edema and mild native T1 signal elevation. Normal right and left ventricular size. Hyperdynamic LV. No significant valvular abnormality. Hospital Course: In brief, this is a 63 y.o. year old female admitted on 5/13/2021 with chest pain, troponin elevation and found to have normal coronary arteries. Preserved LV systolic function by echocardiogram. She underwent an cMRI demonstrating myocarditis. She was started on colchicine and remained pain free for the rest of the admission. Myocarditis: Presented with acute onset chest pain and troponin of ~2000. Diagnosed via MRI after normal coronary angiogram. Normal biventricular function. Etiology is likely idiopathic as she had no other obvious inciting events. Pain free prior to discharge. o Colchicine 0.6 mg twice daily. o Follow-up with Dr. on 6/8 arrival time 12:40 PM Hyertension: well controlled today. Management per PCP o Metoprolol succinate 25 mg daily o Hyzaar 100-12.5 mg daily o Amlodipine 10 mg daily Hyperlipidemia: tolerating atorvastatin 20 mg daily. "

Patient has history of polychondritis w recent flare of recalcitrant scleritis and painful lesions toes thought to be vasculitis and likely related to underlying polychondritis diagnosis; was under treatment for same w prednisone, humira. 4 days after 2nd COVID vaccination Pfizer patient began to report shortness of breath; After Sx persisted was referred to cardiology and found to be in atrial fib; she received cardioverson and placed on eliquis and symptoms have resolved

4/28/21 Pt presented to the ED with complaints of a cough that started 2 weeks ago and was getting worse and weakness with several falls. She also admitted to intermittent diarrhea. She was found to be febrile with a temp to 101.1, tachypneic w/RR of 20. Sats were in the low 90's. NP was was positive for SARS-CoV-2. CXR showed bilateral opacities and she was admitted for PNA and sepsi. She was given Rocephin and Z-max in ED and both were discontinued upon admission. She was started on Decadron in ED 4/30 she had increasing hypoxemia and was placed on a non rebreather. She was transferred to critical care and given tocilizumab. Her respiratory status continued to worsen and she was intubated. She subsequently developed a pneumothorax that persisted despite 2 chest tubes. She developed a large air leak and she was not a surgical candidate. Family ultimately decided to w/draw care on 5/15/21

Passing out multiple times; Heart stopping for 11seconds; Lightheaded; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Apr2021 01:15 as UNKNOWN, SINGLE DOSE for covid-19 immunization. The patient past medical history included high blood pressure, borderline diabetes, penicillin allergy and sulfa allergy. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID. On an unspecified date in Apr2021, the patient experienced lightheaded and passing out multiple times and heart stopping for 11seconds and visited emergency room. Patient was hospitalized for 3 days. Eventually needing a pacemaker. Reported seriousness criteria: Life threatening and Hospitalization. The patient was not diagnosed with COVID-19 prior to vaccination and tested for Covid-19. The patient lab test includes sars-cov-2 test: negative on 27May2021. The outcome of the events was unknown. Information on the batch/lot number has been requested.

Deep Vein Thrombosis. Pain began in right groin on Apr 17 2021. Pain increased throughout the day. Apr 17 2021 pain began in lower right leg; cramp feeling in shin and calf. By that afternoon, Lower right leg showed swelling. Pain and swelling worsened by Monday Apr 19 2021 and I sought medical care that afternoon. Ultrasound showed DVT extending from groin to foot. Placed on Elaquis and Norco for plan. D/c HRT immediately.

She got the vaccine about 5:30 PM May 24, 2021, and initially did fine. In the middle of the night she awoke short of breath, coughing, felt she could not breathe. She denied any itching or hives. Denied any swelling in throat or mouth. Tried antihistamine. Next day, went to work, still short of breath, and in mid day came to see us in the office. She was wheezing and oxygen saturation was 89%. ( 96% is normal), and hypertensive. RR was 24-30. BP was 160/104. We sent her to ER for possible anaphylaxis to covid vaccine. In ER was treated with albuterol nebs, duonebs, prednisone, and admitted to the hospital on 8 liters oxygen. She was in hospital 5/25/21 to 5/27/21 and sent home off oxygen, on prednisone DC diagnoses were Acute respiratory failure with hypoxia Systemic Inflammatory Response Syndrome Tobacco Use elevated BP reading Chest pain Anxiety, COPD exacerbation (I would comment she has never had this before; hospitalist made that diagnosis based on cigarette use and wheezing and hypoxia)

vaginal blood spotting; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 08Mar2021 (Lot Number: EN6202, at the age of 63-year-old) as single dose for covid-19 immunisation. Medical history included abnormal cervical papanicolaou smear, ongoing eustachian tube dysfunction, ongoing Factor V Leiden Thrombophilia, ongoing hearing loss, laparoscopic Gynecology (GYN) surgery in 2007, an outpatient surgery to scrap the walls of her uterus similar to a dilation and curettage (D&C) in 2005, blood clots, excessive bleeding, ongoing Factor V Leiden heterozygote. Concomitant medication included ongoing multivitamins. Soon after her first vaccine on 08Mar2021 she started vaginal blood spotting. She had not had a period for over 15 years. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

I had a strong pepper feeling in my throat. It felt like a ball of pepper was in my throat. I was able to breath but I had to keep clearing my throat. My face, eyes, and throat started swelling up. I was rushed to the ER. My throat was dry. They immediately gave me the EpiPen. My body started acting uncontrollably. I was shaking and shivering and going through a bunch of uncontrolled body movements. They gave me oxygen. I had an IV in my left arm and they gave me injections in my right arm. I was very dizzy. They continued to observe me, they drew my blood. More doctors came in and they told me not to get the second dose of the vaccine. I was transported to hospital by ambulance. 2 o'clock in the morning they told me I could go home and they gave me a prescription. I was very jittery. It was hard for me to walk. I went home with the prescription. Around 7 o'clock in the morning I woke to take my prescription. I had heart problems. I was still dizzy, jittery, and nervous. I called my PCP to put in my prescription and was told to go back to urgent care immediately. My eyes, nose, lips, and throat swelled. I could still breath but my tongue felt different. After they saw me again, I got another EpiPen in my leg. I started shaking uncontrollably again. They injected me in my right arm to calm down the reactions. I was kept there till 9pm that day. It was difficult for me to walk again. I went home and laid down. They gave me prednisone for 7 days. On the 3rd day I was having heart problems again. During that time I didn't have a appetite. My intestines felt like they were trying to come out of my body. I was very uncomfortable. I had gas. I put myself on a schedule to eat soup. I was very nauseous. Those symptoms lasted for 6 weeks. I couldn't drive for 4 weeks. I was still dizzy. I was able to sleep for 4 hours. I couldn't remember things. I have a cough that hasn't gone away. My doctors told me I am anaphylaxis.

Pt was hospitalized on 4/27/21 with pneumonia due to COVID-19 after receiving the first dose of Pfizer on 4/15/21. Per guidelines, all hospitalizations are to be reported.

In beginning of March 2021, noticed blood pressure was elevated. My physician changed my medication one in the afternoon and one in the morning, but after I had the second vaccine she adjusted my medication dosage up. In the middle of March my blood pressure suddenly dropped, and I went to the ER, they did cardiogram levels, EKG, chest x-rays, echocardiogram, kept me over night, because they thought I might have had a stroke, but I did not. I believe that it was the change in my blood pressure medication. My blood pressure elevation went up to 180 for diastolic and was running between 120 or 140 with my blood pressure medication. In April 2021, I started feeling I was getting a cold, went to a clinic, saw a NP gave me medication and four days later I went again to the ER. On 04-21-2021 at the ER, all exams were repeated, EKG?s, found I had bilateral pneumonia, heart blockage. I am a nurse scientist, I think they survey is not written correctly, my opinion, the instructions should be clearer to any person reporting an symptoms.

Client was diagnosed with blood clot after first vaccination in the lung Lower right. After second vaccine had acute thrombosis of the left leg. Client was hospitalized for both events.

J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC)

History of Present Illness: This is a 63-year-old Female Patient with a history of B-cell lymphoma presents to the ED with progressive weakness and stroke like symptoms. She states that her weakness has gotten increasingly worse since she got her 1st Covid shot about 1 month ago, and progressed to R sided hemiparesis. She has not received the 2nd shot per oncologist recommendation. She has been worked up for right arm weakness. She states she has seen an ophthalmologist for trouble with her vision. She had an MRI of her brain the beginning of June which was unremarkable. She developed dysphagia and has a feeling of something stuck in her throat, she also developed facial droop so she presented for further evaluation and treatment. Assessment: 63 Y.O female with a history of B-cell lymphoma presents with progressive weakness that worsened after her 1st covid vaccine. She has developed facial droop and R sided hemiparesis. Plan: Acute medical Problem Generalized weakness/ stroke like symptoms Chest X-ray, CTA head and neck, and brain MRI unremarkable PT/OT/ST eval and treat Neuro checks 6/3/2021 DX : Paired Brachial veins is partially thrombosed

GI symptoms; ITP recurrence; ITP recurrence; This is a spontaneous report from a contactable physician. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 15May2021 (Batch/Lot number unknown), as dose 2, single, at age 63 years old, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had a remote history of Idiopathic Thrombocytopenic Purpura (ITP) from an unknown date, not reported if ongoing or not. The patent was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient received unspecified medications within 2 weeks of vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) received on an unspecified date (Batch/Lot number unknown), as dose 1, single, for COVID-19 immunisation. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. On 22May2021, 7 days after the second vaccination, the patient experienced nonspecific constitutional symptoms and some GI symptoms. The patient was found to have ITP recurrence. The events resulted to hospitalization on 23Jun2021. Treatment for the events included IVIG and steroids. The patient was recovering from the events. It was unknown if the events were associated with the vaccine dose. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate

Around 3/10/2021, I started to notice missed heart beats. Those episodes became more frequent with SOB. I was getting them multiple times a day in addition to chest discomfort and generalized pain. I have a nursing background and notice it is ventricular in nature. Around the 1st week of April 2021, I consulted with a cardiologist and did an EKG, Stress test, ECHO and Holter monitor. The Holter monitor confirms multiple v-tach. I was prescribed a Metoprolol and Verapamil. I am being referred to an electrophysiologist and I have been out of work since 6/9/2021. Even with the new medications, I am still having cardiac issues and tachycardia.

Increased SOB while at Dialysis and had to discontinue dialysis. SOB/CHF warranted admission to the hospital- diuresis and supplemental oxygen.

A month after the shot, dizzyness, heart palpatations, off balance, trouble speaking. Officially diagnosed as having TIA stroke. First episode in March. Other episode in April, May and June. Second eposide in April was more severe than in March.

EMERGENCY RUN TO HOSPITAL FOLLOWED BY HELICOPTER. WAS UNABLE TO TALK AND WAS NOT AWARE OF WHAT WAS GOING ON FOR A COUPLE DAYS. SPENT 6 DAYS IN THE HOSPITAL WITH MULTIPLE TESTS. STARTED TO GET MY SPEACH BACK AND MOBILE ABILITY. WAS RELEASED WITH THE FINAL DIGANOSIS BEING A MILD STROKE. WAS ENCOURAGED BY SEVERAL MEDIAL STAFF TO REPORT THIS SINCE I HAD THE THE VACCINE JUST A FEW MONTHS PRYER.

She had to have a blood transfusion when she was in the hospital; When it stretched out a bubble of blood came up.; hematoma on top of the stitches; Fluid was in there; They are making sure her kidneys are working; She had a sore arm; she has gained 20 pounds.; This is a spontaneous report from a contactable consumer. This 63-year-old Female consumer (patient) reported for herself. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: PAA156051), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 as dose 1, single, dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot Number: EN6201) as dose 2, single for COVID-19 immunization. Medical history included surgery (She had surgery on her neck and spine 15 years ago) and has been on Lyrica since. The doctor messed up and got a nerve and the doctor prescribed her Lyrica. Her leg would be dragging if she didn't take Lyrica. Her doctor told her she could get off of it if she wanted to, but caller doesn't want to. It is too much of a process to do that. The patient's concomitant medications were not reported. The patient reported that she had hip replacement and she also stated she had hematoma on top of the stitches. Caller stated that she took Lyrica when she was in the hospital after her hip replacement. Caller clarified that two weeks after the second hip replacement she had to go back to the hospital due to a little bump on the road and was there for six days. Caller clarified that she had two hip replacements. The first one went fine, but the second did not. The first hip replacement was on her left hip and the second hip replacement was on her right hip. She had gained 20 pounds. She had been home since February. She had not worked since Feb 2021. The patient was hospitalized for hip replacement (hip arthroplasty) from 01Mar2021 to 02Mar2021. At first caller stated the hip replacements was outpatient, but then clarified that she was hospitalized for one day after both hip replacements. She had the first hip replacement on 01Mar2021 and stayed one night in the hospital and was discharged on 02Mar2021. She had the second hip replacement on 18Jun2021, and they kept her one day in the hospital and discharged her on 19Jun2021. Then two weeks later she went back to the hospital and stayed for six days. Caller clarified that the reason she was back in the hospital two weeks after the second hip replacement was due to hematoma on top of the stitches (unspecified date). The staples had stretched out on the suture. When it stretched out a bubble of blood came up (unspecified date). They told her to massage it. She could not see it. It must had popped it and fluid went everywhere (unspecified date). Fluid was in there when her doctor opened her up again. He wanted to make sure her hardware was sterile, so he went in and cleaned it up. She was on IVs for the next 4 weeks. Caller clarified that her doctor took out her stitches and then called her the next day and she still had fluid, so her doctor wanted her to go in. Her stepdad had the same doctor and the same thing happened. Her stepdad rejected it and the doctor did not want caller to reject hers like her step dad. No further details provided. she has had a lot of blood work when she was in the hospital. She had to have a blood transfusion when she was in the hospital because it went low to six. She has a nurse that would come to her house twice a week to take blood work because she was on antibiotics. They were making sure her kidneys were working (unspecified date). No further details provided. Caller stated she did not have any reactions or anything like that. Some people wished they had nothing. She had a sore arm, but she had put an ice pack on it. Her mother was 85 and had Pfizer COVID vaccine and had no problems. Caller had the vaccine card to provide product information. The patient underwent lab tests and procedures which included blood test: low to six on unspecified date. Outcome of all the events was reported as Unknown. No follow up attempts are needed. No further information is expected.

Experienced heavy bleeding coming out of the vagina this morning.; This is a spontaneous report from a contactable consumer or other non hcp. A 63-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 12:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 81 mg for an unspecified indication. Medical history included and concomitant medications was not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced heavy bleeding coming out of the vagina this morning on 24Apr2021 07:00 with outcome of recovered with sequelae. No treatment was received. Follow-up (24Jun2021): This is a follow up-spontaneous report from a contactable Consumer. This Consumer reported for the female patient in response to Non-HCP letter via follow-up letter which included the information. Follow-up attempts are completed. No further information is expected.

Her INR was 5.8 (normal range 1 to 2)/increasing INR; Scratched arm; Scratched arm and bled through 3 shirts, it kept bleeding; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EC1284), via an unspecified route of administration administered to left arm/deltoid on 29Dec2020 13:15 at single dose for COVID-19 immunization at a research medical facility; and received warfarin sodium (COUMADIN, strength 2 mg), oral (by mouth) from an unspecified date in 2017 and ongoing at "3 1/2 tablets once daily in the evening at 5:30pm (total 7mg)" for metal heart valve. The patient's medical history included had the surgery (for her metal heart valve), about 01Mar in 2017 (about 4 years ago) and so she thought she had been on Coumadin for about 4 years, had been on the 7mg dose for over a year; and has a history of metal heart valve and takes Coumadin for the metal heart valve. Denied illness. Denied family medical history relevant to event. There were no concomitant medications. The patient previously received Shingrix vaccine in past and remenbered she had the usual side effects from it, had mild symptoms. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient did not receive any other vaccines the same date of the Pfizer Suspect or 4 weeks prior. On Jan2021, the patient experienced scratched arm and bled through 3 shirts, it kept bleeding. On 04Jan2021, her international normalised ratio (INR) was 5.8 (normal range 1 to 2). The events did not lead to emergency room visit, however led to physician office visit. The events were reported as serious medically significant. The nurse got the first Pfizer COVID-19 shot on 29Dec2020 because she is a healthcare provider. She wanted information on increasing INR. The nurse has a history of metal heart valve and takes Coumadin. Her INR was typically 1.7 to 2.3. She reported her last INR, before the covid-19 vaccine was given, was "some time ago" but it had not varied much over the years. Normally she got her INR run and it was about 2. She had to be scheduled for her INR on the 04Jan2021 and it was 5.8 (normal range 1 to 2) and they asked about anything that may have changed and the only thing was that she got her first shot. The nurse reported not having any changes in her medications, food, or life style to account for the change, other than receiving the COVID-19 vaccine. The patient stated that it could be a serious problem if she had an accident or fell and started bleeding. A normal person's lab result is between 1 and 2, but they like to keep people with the metal heart valves between 2 and 3. She had been bleeding. She had barely scratched her arm the other day and went through 3 shirts because she kept bleeding. This is more than unusual for her, it's kind of unusual. Getting the vaccine is the only variant she has had since getting her last INR. The patient underwent lab tests and procedures which included INR (normal range 1 to 2): typically 1.7 to 2.3 on an unspecified date; it's about 2 on an unspecified date: and 5.8 on 04Jan2021. The action taken in response to the events for warfarin sodium was dose not changed. The outcome of the event INR was 5.8 was not recovered, for the other events was unknown. The nurse (patient) assessed the event "INR was 5.8; it's normally about 2" as related to the COVID-19 vaccine.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of International normalised ratio increased and wound hemorrhage due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics coagulation panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Patient received Covid 19 vaccine at 4:00 PM. She has a history anaphylactic reaction from a bee sting. She was advised to wait in observation area for 30 minutes after receiving vaccine. After 20 minutes she complained of being light headed and dizzy. She was given apple juice to drink. Declined crackers. States she ate lunch about 2 hours ago. 4:39 PM VS taken by personnel. BP 126/73, HR 58, pulse ox 100%, Blood sugar 101. 16:45 PM BP seated 110/65, HR 62, 16:46 BP standing 113/60 HR 58. 16:50 PM. Patient states she is feeling better and is fine to drive a short distance home. Advised to return if she has any dizziness while leaving the building. Lead RN, was consulted regarding this patient.

COVID- 19 Vaccine. She was experiencing chest tightness, SOB, and dizziness. 50mg of Benadryl and 20mg of famotidine was administered around 1410. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3mg of epinephrine was administered at 1420. EMS was called. Breathing improved. Pulse ox 100%, HR 68, BP 130/89. EMS arrived and assumed patient care. Pt seen in Emergency Room 1/16/2021 1513 CHIEF COMPLAINT: reaction to COVID vaccine HISTORY OF PRESENT ILLNESS: Patient is a 64y F with PMHx significant for Myopericarditis, Anxiety and HTN who presents to ER after developing tongue swelling, wheezing, tunneled vision and shortness of breath. Patient states that she was getting first shot of COVID19 Pfizer vaccine at 2:00 pm. After getting vaccine she waited 15 minutes like she was told and recalls room getting very hot at approximately 6 minutes after getting vaccine. She also states that her tongue felt swollen. She then noticed her vision started to turn dark and then she felt dizzy. She told pharmacist about symptoms and then she was given one pill of Benadryl. This did not help and actually made her symptoms worse. She recalls wheezing. She was given another pill of what she believes was Benadryl. She also recalls pharmacist measured her BP and her husband, who was present, reported that her blood pressure was in the 140s This did not improve so she was given 0.3mg IM epinephrine shot. This significantly improved her symptoms. However, she was sent to ER. She denies any hx of recent UTI or GI infection. She denies fevers, chills, nausea, diarrhea, chest pain, generalized itching, vomiting, abdominal pain, generalized swelling, headache or syncopal episode. She denies any past reactions to vaccines. She denies current SOB and feels like her symptoms resolved. Denies hx of COPD or asthma. Physical exam did not show any recurrent signs of wheezing or tongue edema. Her SaO2 was 100% on RA and BP was within baseline 140-160s. Given episode, we decided to obtain tryptase levels. We also observe patient to ensure she did not have any recurrence of symptoms. She remained hemodynamically stable and SaO2 remained in mid 90s to 100. She was given a rx for epinephrine pen should symptoms recur though this is highly unlikely as she remained stable throughout ER stay. She was also given instructions to pick up OTC Benadryl and Pepcid. She does have antihistamines listed as an allergy but patient states that she gets tachycardic upon taking tabs, so this could just be a side effect. We will follow up with tryptase levels but even if tryptase levels return as normal, it does not mean she did not have an anaphylactic reaction to vaccine. Her clinical picture puts this diagnosis high in the differential. Teaching and instructions were given to patient and her husband. She was advised to return to ER if symptoms recur. IMPRESSION: Anaphylaxis Anxiety attack

Client reported metallic taste in her mouth approx. 1 minute after receiving the vaccine. She said her trouble breathing was before the vaccine, not after. " I have trouble breathing because of my COPD and my back hurting". Client says she was diagnosed this week with pneumonia. She tried to take Trilogy but she couldn't tolerate it.

Anaphylaxis; SOB (shortness of breath)/ difficulty breathing; Chest tightness; dizziness; Wheezing; Anxiety attack; Medication-induced allergic reaction; Blood pressure (BP) increased for 130/89; This is a spontaneous report received from a contactable pharmacist. A 64-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), intramuscular on left arm on 16Jan2021 at single dose for COVID-19 immunization. Medical history included HTN (hypertension), mopericarditis, anxiety and allergy to antihistamine tabs. The patient's concomitant medications were not reported. It was reported that, the patient was experiencing chest tightness, SOB (shortness of breath), and dizziness on 16Jan2021. 50 mg of Benadryl and 20 mg of famotidine was administered around 14:10. Patient was still experiencing chest tightness and was having difficulty breathing. 0.3 mg of epinephrine was administered at 14:20. EMS was called. Breathing improved. Pulse Ox 100%, HR (heart rate): 68, blood pressure (BP) increased for 130/89. EMS arrived and assumed patient care. ED COURSE: Patient was seen and examined with doctor. Patient developed of SOB, dizziness, wheezing after receiving first shot of Pfizer COVID vaccine. She received Benadryl upon development of symptoms, which actually made them worse given her allergy to antihistamine tabs, but her symptoms improved upon administration of 0.3 IM epinephrine shot. Differential diagnoses include but were not limited to anaphylaxis, anxiety attack, medication-induced allergic reaction on 16Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. The patient visited emergency room/ department or urgent care due to the events. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown whether the patient has been tested for COVID-19, since the vaccination. The events were assessed as non-serious by the reporter. Therapeutic measures were taken as a result of events. The outcome of the events was reported as recovered on an unspecified date in Jan2021.; Sender's Comments: Based on the information provided and temporal relationship, a causal association between BNT162B2 and the reported events cannot be completely excluded. The treatment with Benadryl most likely contributed to the events as the patient is known allergic to antihistamine tabs. 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 developed pneumonia Admitted to hospital on 12/25. Determined to have pseudomonas bacteremia and passed away on 12/27.

In 4 hours, started getting getting very dizzy, then throwing up, and nauseous by 7:30pm felt Luke on worse six flag ride. Blood pressure went up to 166/106. Called 911. Diagnosed with possible reaction and developed TIA

Moderate anaphylactic reaction - according to doctor I consulted afterward. Throat swelled - difficulty breathing and swallowing, weak, dizzy, rapid heart beat - started about 16-17 minutes after the vaccination. Lasted a little over 3 hours. Profound fatigue the next day.

48 hours (Feb 26) after receiving the shot, I had anaphylaxis symptoms... red blotches around mouth, swelling face, swelling lips, ants-crawling feeling on face, neck and scalp. Went to Urgent Care, given benadryl and steroid shot. Rx Prednisone 20 mg x2, 5 days. Anaphylaxis happened again the next day (Feb 27) just prior to taking the first prednisone. Went back to Urgent Care, another shot. Meds kept full on allergic reactions at bay on Monday and Tuesday. Had swelling face, lips and tongue happen in Primary Care office on March 3, received another shot and increased prednisone rx to 30 mg x2, with taper. On March 5, happened again, went to ER, where doc changed timing of prednisone to 60 mg all in one dose. All in conjunction with hydroxyzine 25 mg every 12 hours and 50 mg of benadryl every six hours. Situation continues with mild swelling, itchy sensations happening just before it is time to take new meds .

THE FOLLOWING DAY AT 5;00 PM AFTER VACCINATION, I WAS COUGHING UP BLOOD AND WENT TO THE ER. AT THE ER THINGS GOT PROGRESSIVELY WORSE AND I WAS LOSING QUITE A BIT OF BLOOD AND MY OXYGEN DROPPED INTO THE 70'S. I WAS ABOUT TO BE INTUBATED, BUT THE ER DOCTOR TRIED A BREATHING TREATMENT AND ATIVAN FOR ANXIETY WHICH SLOWED THE COUGHING DOWN. I WAS ADMITTED TO THE HOSPITAL AND MONITORED FOR THREE DAYS. I AM HOME NOW AND I STILL COUGHING UP RESIDUAL BLOOD CLOTS. IWAS GIVEN ANTIBIOTICS AS WELL.

My mother became short of breath over the course of the week after her second dose of the the Pfizer Covid19 vaccine. She was taken to the emergency room and was diagnosed with pericardial effusion and admitted for treatment that included draining fluid from the sac around her heart. She was released and then developed the same symptoms again within a week. She again had pericardial effusion, and was told she had severe emphysema with no prior diagnosis. She is still hospitalized and is now suffering heart failure with no clear diagnosis as to why, no acceptable plan of treatment, and a prognosis of wait and see. She has consistently tested negative for Covid19.

On 2/16/21 I suffered an occlusive stroke. No health problems. No prescriptions meds. BP was always around 120/70's. Height: 5'4", Weight: 126 lbs. All blood work within normal range No high chlolestrol, etc. I was scheduled for 2nd vaccine on 3/1, I was advised to reschedule, which I did for 3/23. I spoke to a coule of health care professionals and asked them if they would proceed with the 2nd vaccine if it were them and was told "no". I am very afraid to get the 2nd vaccine. I would like to discuss this with someone.

Admitted to hospital- Acute severe progressive hypoxic respiratory failure- intubated, trach placed, COVID-19 pneumonia, Afib Patient treated at primary care office 01/13/2021 for respiratory illness (tested negative for COVID at this time), had vaccine 01/20/2021, developed headache and tested positive COVID-19 the following day 01/21/2021. Symptoms worsened with nausea and shortness of breath. Patient admitted 01/29/2021, condition progressed- intubated 02/07/2021, trach placed 02/25/2021.Discharged to specialty hospital 03/12/2021 for continued respiratory support and rehabilitation

allergic to something in the vaccine; Myoclonic jerking; I felt very hot; I started shaking uncontrollably.; Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 at 16:00 (at the age of 64)(Batch/Lot Number: EN6205) as a single dose for covid-19 immunisation . The vaccination was given at a hospital. There were no other vaccinations given within 4 weeks. The patient was not diagnosed with COVID prior to vaccination. Medical history included breast cancer and an allergy to sulfa drugs. Concomitant medication(s) included cetirizine hydrochloride (ZYRTEC ALLERGY); levothyroxine, liothyronine (NP THYROID). On 25Feb2021, about 2 hours after the vaccination (18:30) I felt very hot. I was not running a fever. I started shaking uncontrollably. The shaking was not chills. My husband took me to the emergency room. This was their summary. Elevated blood pressure reading without diagnosis of hypertension; Elevated blood sugar level; Myoclonic jerking; Vaccine reaction I saw my general practitioner the following day and everything was back to normal. I am allergic to something in the vaccine and I am afraid to get the 2nd dose. No treatment was given for the events.The outcome of the events was recovered. The patient was not tested for COVID post vaccination.

1st COVID vaccine 2/10/2021 . Dx with COVID 2/17/2021. 2nd dose COVID vaccine 3/22/2021. On 3/24/2021 developed petechial rash. On 3/25/2021 presented to ER for evaluation. Platelet count 4,000. Patient admitted to hospital with ITP. Started on IV steroid and given platelet transfusion.

Client report receiving second COVID dose on 03/29/21 at 2:45 pm, later that evening at 6pm began to have Afib. Her Afib lasted 36 hours, which is not normal for her. She contacted her PCP, told if it continues cardioversion. Client's Afib stopped this morning (03/31/21) at 0515. No treatment needed.

acute left leg pain and swelling 15 hour after vaccination with subsequent same day ER visit and ultrasound diagnosis of acute left leg DVT (blood clot) diagnosed.

The next day following the vaccine my arm hurt slightly at the injection site, my head felt strange slight pressure maybe inflamed my face was red my blood pressure was higher for the first day. The following days my head felt strange again and my face would get red and it would come and go. but blood pressure was normal. Mid week the entire left side of my body felt like my body worked out but I didn't exercise. Today eight days after the vaccine blood was on the tissue after urinating in the morning upon waking again in the evening there was more blood on tissue.

I got the shot on 3/22 and on 3/25 I was hospitalized for a flare-up of ITP with a platelet count of 14. Got 2 units each of dexamethazone, IVIG, and platelets. Released on 3/27 with a count of 161. Readmitted 4/5 with a count of 11. One round of platelets, count fell to 8 in 24 hours. Then I got 1 round of IVIG, count raised to 10 in 24 hours, which was this morning. Advised not to get 2nd shot.

Two weeks after receiving the vaccine I went to the ER with excruciating pain in my chest. Was diagnosed with a pulmonary embolism. My son who is 33 yes old had the same result after his first Pfizer vaccine in the exact same time frame - yesterday.

I developed weak, rapid, irregular heartbeat indicative of atrial fibrillation; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection and Lot Number: ER2613) via an unspecified route of administration in left arm on 19Mar2021 at 11:00 am (at the age of 64-year-old) for COVID-19 immunisation. Medical history included persistent atrial fibrillation, allergies to sulfa. Patient was not pregnant at the time of vaccination. Heart in regular sinus rhythm for several months prior to vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included dofetilide (TIKOSYN) 250mcgtwice daily, loratadine and ibuprofen, (all received within 2 weeks of vaccination). The patient previously took dofetilide (TIKOSYN) for atrial fibrillation (persistent atrial fibrillation was controlled with 250mcg twice daily); also took erythromycin and had allergies. Patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Mar2021 at 17:15, the patient developed weak, rapid, irregular heartbeat indicative of atrial fibrillation. This last 8 hours. The patient did not receive any treatment for the events. Patient noted regular heartbeat on 21Mar2021 at 1:15am. Patient visited to physician office for events. The outcome for the event was recovered on 21Mar2021 at 1:15am. Follow up attempts needed. Further information is expected.

Drooling noted from the left side of the mouth. Drooping on the left side of the face. Labs, & EKG ordered. The resident has mumbled garbled speech. Walking and sitting in the lobby to go smoking.

blood clotting in legs, lungs, resulting in hospitalization. Second clotting event resulting in stroke and hospitalization, ongoing treatment and evaluation

Benign perimesencephalic subarachnoid brain hemorrhage requiring ER visit, hospitalization, physical therapy plus follow up care.

heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours; body feels like hit with mac truck; tired; This is a spontaneous report received from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm at age 64 years, on 29Mar2021 14:25 (Batch/Lot Number: ER8732) as single dose, for COVID-19 immunisation. Medical history included atrial fibrillation as a pre-existing condition that normally she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most and overweight from unspecified date but working on it. Only she has heart history in her family. The patient's concomitant medications was none. Patient historically took first dose of BNT162B2 (Lot: EN6199) with anatomical Location of left arm on 08Mar2021 around 1300 for COVID-19 immunization and flu vaccine received back in 2020 for immunisation. Patient reported that she had the second dose of the Pfizer COVID Vaccine on Monday, 29Mar2021 and three hours later, her heart started fibrillating for 36 hours. She has a pre-existing condition of atrial fibrillation and normally she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours. Patient contacted the doctor right away via phone. Her doctor, an electrophysiologist, stated not to eat or drink anything after midnight and of patient was still in atrial fibrillation in the morning they would have to perform a cardioversion, with the paddles. Doctor believed this could happen and said its a delicate balance when you put anything else into the system that it could affect persons. On 31Mar2021 at 05:15 that morning, the patient went out of atrial fibrillation and back into normal sinus rhythm. Patient only called the doctor and would have had to go in today if the fibrillation did not stop. Patient also stated that well, it was not a good thing to fibrillate for that long, with due time it can cause congestive heart failure and stated its dangerous. Patient was resting at the time of report and was relieved she is not fibrillating anymore. Patient reported that her body feels like it was hit with a mac truck on Mar2021. Heart fibrillating for 36 hours makes you really tired. The outcome of the event 'heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours' was recovered on 31Mar2021 at 05:15 in the morning, while for the rest of the events it was unknown. Follow-up attempts are completed. No further information is expected.

possible pinched nerve; TIA; heart rate is low anyways from the medications but it dropped to 35 when she was in the hospital/heart rate dropped; her right arm, the right side of her face, and her right knee were numb/ she has numbness in her right finger and right thumb; face feels like its burning; her vision was kind of blurry; sensational loss in her right hand; caller's sclera looked like her eye was bleeding and her pupil started turning a different color.; caller's sclera looked like her eye was bleeding and her pupil started turning a different color.; eye was super red; rupture of a blood vessel in her eye; blood clot in eye; This is a spontaneous report from a contactable nurse (reported for herself). A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER2613, expiry date not reported), via an unspecified route of administration, administered in left arm on 19Mar2021 09:00 at a single dose for covid-19 immunisation. Medical history included ongoing hypertension from 1900 wherein blood pressure was high prior to her atrial fibrillation medications; A fib (atrial fibrillation) from 2016 and ongoing; and ongoing heartrate low. As a child the caller had the vaccine in the sugar cube (unspecified) and her mouth was swelling from it; and stated that patient's sister was hospitalized after receiving the same vaccine. Family medical history included mom has hypertension. Concomitant medications included apixaban (ELIQUIS) taken for A fib (atrial fibrillation) from an unspecified start date and ongoing at 5 mg twice a day; sotalol taken for A fib (atrial fibrillation) from an unspecified start date and ongoing at 80 mg, twice a day; and diltiazem taken for A fib (atrial fibrillation) from an unspecified start date and ongoing at 180 mg, once a day. The patient was a healthcare worker and she has had friends who have died from covid. The patient had no previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccinations (within 4 weeks). The patient stated she had the first dose of the vaccine and had a TIA (Apr2021) and rupture of a blood vessel in her eye 20Mar2021. The TIA was on Monday (Apr2021) and she was supposed to have her second dose tomorrow (09Apr2021). She stated she may get it but she is not taking it tomorrow because she is still having residual symptoms. She asked what the length of time she can wait to get it before she has to restart. Patient reported that after she got her first vaccine she had a ruptured blood vessel in her eye the next day (20Mar2021). She put warm and cool compresses on her eye then the ruptured blood vessel subsided. The ruptured blood vessel came back again a few days later and this time it was the entire sclera. She developed blood clots in her eye and the doctor said it probably wasn't from the vaccine (Mar2021). She was supposed to get her second dose of the vaccine tomorrow 09Apr2021 but she was going to hold off for now. She then had a TIA (Mar2021) and became hospitalized because of it from 06Apr2021 to 07Apr2021. The patient has ongoing atrial fibrillation but has been taking her medication religiously. She believed that the TIA was from the vaccine as there was no explanation as to why it happened. Her heart rate was low anyways from the medications (dates unspecified) but it dropped to 35 when she was in the hospital (Apr2021). The patient's primary care provide was not the attending in the hospital when the caller was hospitalized. Furthermore, it was reported that on 21Mar2021, patient's eye was super red but only on one side of her left eye. On Tuesday, 22Mar2021, caller went to see her primary care provider and they told the patient to put a warm compress and no eye drops in her eye, that helped. Then that Friday, 25Mar2021, the patient's sclera looked like her eye was bleeding and her pupil started turning a different color. Then last Monday (Apr2021), the patient woke up and her right arm, the right side of her face, and her right knee were numb she got up and went to see if she had a facial droop and did not. The patient thought it was from her sleeping wrong, but these symptoms did not go away. The patient went to the Emergency Room where they did a CT of her head and neck, with and without contrast which was negative. The patient was admitted on 06Apr2021 to the observation unit where they did an MRI and ECHO, which were both negative and she was diagnosed with a TIA and possible pinched nerve (Apr2021). The patient denied any heavy lifting prior to this event other than normal day to day things. The patient was discharged on Wednesday 07Apr2021. The patient's face felt like its burning, she has numbness in her right finger and right thumb. Physical therapy and occupational therapy said the patient should be okay but to be careful with things that were hot because she was at risk of burning herself. The second time the patient's eye became red, her vision was kind of blurry (Apr2021) and she didn't know if the blood was in her pupil. The only deficit that the patient has now is sensational loss in her right hand (Apr2021) and that should improve per the occupational therapist at the hospital. The caller was supposed to get the second dose of the vaccine on 09Apr2021 but she doesn't want to take it while she is having these symptoms. Results of tests and procedures for investigation of the patient included: head ct with and without contrast: negative on 06Apr2021; MRI brain: negative on 06Apr2021; Echocardiogram: negative on 07Apr2021; speech evaluation: passed on 07Apr2021. The patient asked what the efficacy is after one dose and if a booster will be needed since she is only protected for 6 months. Patient asked if she needed to restart the series of vaccinations if she doesn't get the second vaccine tomorrow 09Apr2021. The events ruptured blood vessel in eye, blood clot in eye, sclera looked like her eye was bleeding, eye was super red were reported as serious medically significant, and heart rate dropped as life-threatening. As reported, the events required emergency room and physician's office visit. Therapeutic measures were taken as a result of the events rupture of a blood vessel in her eye, and eye was super red. The outcome of the events reported was unknown. As per reporter, the events ruptured blood vessel in eye, blood clot in eye, and heart rate dropped were related to the covid BioNTech vaccine.; Sender's Comments: Based on the temporal relationship, the association between the reported events with BNT162b2 use can not be fully 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.

This is probably coincidental but it's a hell of a coincidence. First Pfizer shot on 4/9, on 4/18 I had an anaphylactic shock reaction to eating a banana. I've never had a food allergy in my life. Had all the symptoms of anaphylaxis except for hives and my throat closing up. It was quite scary and very painful. I did not call an ambulance or go to the hospital.

1st occurrence: After 1st vaccination on March 6th, 2021- intense pain in left leg, passed out, went to urgent care 2nd occurrence: After 2nd dose on March 27th, 2021 - on the 28th flu like symptoms- on the 29th intense leg pain, passed out, transported to hospital by ambulance, doppler revealed blood clot, blood work normal, placed on Eliquis I have since been to the hematologist and had a work up... blood tests are normal

my auntie, who was trying to be supportive and to get vaccinated just passed away like this is not worse it. My auntie, passed away the next two days after she got her Pfizer Covid vaccine. My auntie, who is 65 years old, got her Pfizer vaccine the the morning of April 22 2021. She told us he was completely find on the day of the vaccine. But the next morning around 9 am, she told us she has severe abdominal pain, has the need to have a bowel movement, but she was defecated. She also told us that she vomit couple times already, then she has no more energy to talk. She got into the hospital and she was announced right after midnight at 12:04 April 25th. The reported death reason is due to Bowel Ischemia with Perforation and it has nothing to do with Pfizer vaccine that she got. But I believe it is her post Pfizer covid vaccine reaction that result in Bowel Ischemia with Perforation. My auntie lived with a very healthy life style. She walked every morning, and has a shorter walk in the evening. She has no blood pressure, no blood sugar, everything is fine with her medical check. My auntie had a kidney transplant 20+ years ago and she is on the track for monthly doctor visit. When she asked her general doctor if she could get the vaccine, her general doctor asked her to consult her kidney doctor. She then went to ask her kidney doctor and her kidney doctor call her general doctor to discuss her health conditions. Both of her doctor decided that she could take the vaccine and one of the doctor registered her for the vaccine on April 15 2021. The she nurse told her to came in for vaccine on Apr 22, and she is now death after the Pfizer vaccine. I only read about people with recent organ transplant is not recommended to take the Covid vaccine. But there is no information about people that ever had kidney transplant shouldn?t take the vaccine. My auntie, who was trying to be supportive and to get vaccinated just passed away like this is not worse it without a clear explanation. I would like you to contact health department to follow up on this case and find out the real root cause. If the vaccine is not recommended for people that ever got kidney transplant, CDC should publish the information so that there won?t be more victims. Please take necessary action ASAP. Thank you!

Approximately 3 weeks after her second dose, patient had shortness of breath and chest pain, 2 days after onset present to the emergency department and was diagnosed with acute, moderate volume bilateral pulmonary emboli and a left lower extremity DVT (popliteal vein). Treated initially with lovenox and Eliquis followed by Eliquis alone. Discharged after one day. Recovering well. please see earlier comments regarding vein surgery in Feb 2021, past hx of DVT/PE.

? Tuesday, April 6th ? Patient receives the 2nd Pfizer vaccine shot ? Thursday, April 8th ? Patient is sick with vomiting and diarrhea ? Friday, April 9th ? Patient is delirious and still sick with vomiting and diarrhea. She is also has pain in her stomach. An ambulance is called to take her to the hospital. The hospital determines her white blood count is elevated, indicating an infection. Blood sugar is very high ? approximately 400. Covid test is negative. She is restless upon arrival. She tries to climb out of bed continuously. She is restrained. o Saturday, April 10th ? Patient is running a fever and is in pain. She is also confused and doesn?t recognize her oldest sister. Meds are administered to handle both items. (Toradol?). Blood sugar around 200. She continuously counts and calls for Mother and Father. Patient continues to be restless o Sunday, April 11th - at request of family, a CT scan is done of her stomach and abdomen. Nothing is found. Potassium was at 3.2 (normal is 3.5) so she received an IV drip to help with potassium levels. Sugar ? 206. Later drops to 176. Patient calms down some. She is still confused and doesn?t recognize her oldest sister. ? Monday April 12th ? the hospital attempts to do an MRI, but patient panics. This is a closed MRI and her 1st husband died in one. The MRI isn?t done. ? Tuesday, April 13th ? she is asked by the doctor to state her name and wiggle her toes. She complies. Doctor orders speech therapy. She is sedated for an MRI and a CT scan. Both are successfully completed. She sleeps for the rest of the day. Blood sugar ? 274 @ 5:09pm. ? Wednesday, April 14th ? Patient was asleep all day. Most of the day she isn?t responsive when nurses come in and do things like take blood. She normally responds even if she is asleep. Around 5pm she starts to respond and make noises; she briefly opens her eyes then falls asleep. She continues to run a temperature. ? Thursday, April 15th ? Patient is asleep most of the day. She is responsive when nurses do things like take blood. A spinal tap is performed. There was mention of dementia. Hospital is sharing little information, varying from she is retreating into herself vs. something worth isolating is going on. Temp was 102.3 at 7:37, but later dropped to 99.3 without meds. Dr. (neurologist) provides an update to the family. Tests so far are negative. EEG showed sleeping brain (she was asleep during test). MRI showed nothing. Spinal tap negative so far. No infection or anything has shown up. Orders another EEG and MRI ? Friday, April 16th ? Patient tried to open her eyes. ? Saturday, April 17th ? a met code was called on her and she was moved to ICU. A circulation issue was found in right leg. Occlusion was really bad. Initially the doctor was concerned about blood clots. None were found, just swelling. Pressure was relieved. Blood pressure issues. She was put on 2 blood pressure meds, at least. She was dehydrated and acidic. Diabetic ketoacidosis was mentioned. A cytokine storm was expected. ? Sunday, April 18th ? blood pressure not stable. She was put on dialysis. Peripheral circulation was worse. ? Monday, April 19th ? she coded around 5am. Doctors were trying to save her. She passed away about 30 minutes later .

strokes signs; Two blood clots in the veins in legs; This is a spontaneous report from a contactable consumer. A 64-year-old female consumer (patient) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EN6199/EN6207 (as reported)) intramuscular into the left arm on 10Mar2021 (at the age of 64-years-old) at single dose for COVID-19 immunization. She received the second dose of BNT162B2 dose on 31Mar2021 (lot number unknown). Medical history included high blood pressure and GERD. Concomitant drugs included Toprol 25mg, oral , twice a day for blood pressure stated ''in Feb some time she don't know'' and Protonix 40mg, oral twice a day for years for GERD. The consumer reported that 'she got her first vaccine and she has had the strokes signs''. Further she reported she got her first vaccine dose, then she had leg pain, she went to see the doctor and ordered a doppler. She was put on blood thinners and three days later she got two blood clots in the veins of her legs, right. On 20Mar2021, her leg pain went pretty severe since I had the blood clot, when I got the second shot, it was still there. On 27Mar2021 she started treatment receiving Eliquis 5mg, twice a day for the blood clot and she did take a Physical therapy. When she got the second vaccine dose on 31Mar2021 she was on blood thinners. At the time of reporting the outcome of the event was reported as 'hasn't gotten better, it's the same not better not worse.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Pt came in to receive vaccine around 3pm on 4/27/21, Pharm.D. verifed pt has had a rxn in the past to flu vaccine, which resulted in itching. Patient did not have any difficulty breathing or anaphylaxis from flu vaccine and did not require any extra treatment. Pharm.D. req Patient to stay for 30 minutes per protocol. At 3:15 rash appeared, Pharm.D. gave benadryl. stayed 30 mins from the benadryl dose. Developed anaphylaxis. required epipen at 3:53. ems arriv @4:10

Patient presented to ED on 3/28/21 with the following information: patient reports home daughter was diagnosed with COVID-19 infection a few days ago. For about a week now the patient herself has had severe fatigue, loss of taste, loss of appetite, nausea, vomiting and diarrhea. She denies fevers. She has however had a persistent cough and over the last few days has been short of breath. Tested positive for COVID-19 on 3/27/2021 at outside facility. Last night patient had multiple episodes of diarrhea making her fatigue significantly worse today. Has been drinking a lot of free water. Additionally noted increased cough and shortness of breath. Patient was admitted to the hospital with COVID-19 pneumonia on 3/28/21 and expired on 4/13/21.

Angioedema; Shock; stridor; dry cough; Hoarse voice; Sneezing; Rhinorrhea; Dizzy; nausea; Hypotension; Weakness feeling; Generalized erythema; Generalized pruritus with skin rash; Generalized pruritus with skin rash; Diarrhoea; Vomiting; Throat closed in; the sides of the throat, down my neck , straight over my chest felt as if someone was squeezing me, chest felt heavy; Potential anaphylactic reaction; Difficulty breathing; severe brain fog; Severe chest pain hard to breath felt as if being smothered; difficult to sleep nights before as felt wired after the shot; bp slightly elevated 140/80; Became very groggy; eyes heavy, had about 3 sleep attacks; 3 sleep attacks; This is a spontaneous report from a contactable Health Care Professional (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot Number: EN4206) at single dose, intramuscularly, in the left arm, on 05Mar2021 at 10:00 AM, for COVID-19 immunization. The patient also received hylan g-f 20 (SYNVISC), via an unspecified route of administration, in knee, on 04Mar2021, at single dose, for an unspecified indication. Relevant medical history included narcolepsy from an unspecified date, in 1973, cataplexy from an unspecified date, complex regional pain syndrome (CRPS) from an unspecified date, in 2003, osteoporosis from an unspecified date, gastrooesophageal reflux disease (GERD) from an unspecified date, hypertension from an unspecified date and arthritis from an unspecified date, in 2003. Concomitant medications included methylphenidate hydrochloride (RITALIN), imipramine, baclofen, atenolol, rosuvastatin calcium (CRESTOR), ezetimibe (ZETIA), imipramine hydrochloride (TOFRANIL), montelukast sodium (SINGULAIR), acetylsalicylic acid (BABY ASPIRIN) and clonidine, all taken for an unspecified indication, start and stop date were not reported. The patient reported allergy for drugs like lisinopril, spirolactone, ghb (gamma-Hydroxybutyric acid), epinephrine and all seizure type medications. The patient became very groggy, felt eyes heavy, had about 3 sleep attacks, on 06Mar2021, at 13:00. Also reported difficulty to sleep nights before as felt wired after the shot (insomnia) and bp was slightly elevated 140/80 on 07Mar2021. On 27Mar2021 at 13:00, throat closed in, felt the sides of the throat, down her neck, straight over her chest felt as if someone was squeezing her, chest felt heavy (severe chest pain hard to breath, felt as if being smothered, throat closing in severe chest heaviness). Severe brain fog. Potential anaphylactic reaction and difficulty breathing were reported. On an unspecified date, the patient experienced angioedema, shock, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus with skin rash, diarrhoea and vomiting. Decrease level of consciousness and loss of consciousness were not reported. The patient underwent lab tests and procedures which included oxygen saturation: normal on 06Mar2021 and blood pressure measurement: 140/80, slightly elevated, heart rate: 99, respiratory rate: 20 on 07Mar2021. The patient was not hospitalized and was not admitted to an Intensive care unit. The patient did not have COVID prior to vaccination and the patient did not test COVID post vaccination. The patient recovered from throat constriction, chest heaviness, potential anaphylactic reaction and difficulty breathing. Clinical outcome of angioedema, shock, chest pain, stridor, dry cough, hoarse voice, sneezing, rhinorrhea, dizzy, nausea, hypotension, weakness, generalized erythema, generalized pruritus, skin rash, diarrhoea and vomiting was unknown. Outcome of the other events was reported as recovering. Follow up attempts are completed. No further information is expected. Follow up (26Mar2021): New information received from a contactable Health Care Professional includes: adverse events added, clinical course and case seriousness updated from non-serious to serious. Follow-up (20Apr2021): New information received from a contactable Health Care Professional includes: medical history, concomitant medications details and additional adverse events added (Potential anaphylactic reaction and difficulty breathing added as additional adverse events). Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on known safety profile and/or temporal association, the contribution of the suspect drug to the onset of serious 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 RAs, Ethics Committees, and Investigators, as appropriate.

4/10/21-Patient presented to an outlying hospital ED w/acute N/V/D and abdominal pain. She was found to have pancreatitis and was found to be SARS-CoV-2 with screening for admission. She had a history of symptomatic COVID with a positive NP swab 1/2/21. Because the patient had no respiratory symptoms she was considered "asymptomatic." She rapidly progressed to having severe necrotizing pancreatitis. She was transferred to tertiary care center where she remains hospitalized. Her hospitalization has been complicated by acute hypoxic and hypercapnic respiratory failure requiring intubation x 24 hours. She had mental status changes and an MRI revealed posterior reversible encephalopathy syndrome, acute kidney injury, splenic vein thrombosis -parital occlusion.

This 64 year old female received the Pfizer Covid shot on 4/6/21 and went to the ED on 4/20 /21 and was admitted on4/20/21 with the following diagnoses listed below. I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) I63.9 - Cerebral infarction, unspecified R29.810 - Facial weakness

This 64 year old white female received the Pfizer Covid shot on 3/30/21 and went to the ED on 4/16/21 and was admitted on4/17/21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident) BLURRED VISION SPEECH PROBLEM

feeling so bad; couldn't hold anything down/Vomiting that wouldn't stop/vomiting; Diarrhea; Nauseous; It was just bile coming up; Headache; Was passing clots/were clots/in the vaginal area; Was passing clots/were clots/in the vaginal area/vaginal bleeding; Being dehydrated; couldn't hold her own weight up; stomach pain; So sick; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; White blood cell count and kidney and liver function were all elevated; A sharp pain in her side; Stools were dark tarry stringy stuff; Stools were dark tarry stringy stuff; Passing blood in her urine; allergic internal reaction; Weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter; This is a spontaneous report from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, at age 64 years, administered in left arm on 05Apr2021 10:30 (Batch/Lot Number: ER8734) as single dose, for COVID-19 immunization, in order to go back to normal, without a mask so she was told she had to have one. Medical history included hysterectomy, anxiety, disorder in thyroid and cholesterol. Patient had family history of dementia, had to stay home and take care of her mom who is a heart patient and has dementia. Patient had no history of previous immunizations. Patient's concomitant medication includes unspecified medications one is for thyroid, one is for cholesterol and the other 2 are for anxiety. Patient had no prior vaccinations within 4 weeks. No additional vaccines administered on the same date. Patient's symptoms started with a headache the morning after the shot (05Apr2021), was on and off for a couple of days, lasted 3 days or so for a couple days and she took paracetamol (TYLENOL). On 09Apr2021, Friday morning, patient woke up so nauseous she couldn't hold anything down. It was just bile coming up, and she had severe diarrhea and so sick vomiting that wouldn't stop, stomach pain, couldn't hold her own weight up. She got medication at a walk in clinic and that didn't stop it. She started out at acute/urgent care, where she was taken by her daughter on Sunday, 11Apr2021, because she was feeling so bad and was tested for COVID and they said if it does not get better to go to the Emergency Room and she continued having problems. It was not COVID. They said she was dehydrated and send her home to push fluids and drink Pedialyte. Monday or Tuesday (Apr2021) she was in the ER all night (she does not remember the day because all of her days are mixed up). They did CAT scans on her abdomen and ran blood work. They didn't see anything in her abdomen. Her white blood cell count and kidney and liver function were all elevated and they said it was from being dehydrated from diarrhea and vomiting. They gave her fluids and sent her home. Within another 48 hours she still had vomiting and diarrhea, it was a clear bile and a sharp pain in her side. Her stools were dark tarry stringy stuff so she went back to the ER and waited in the lobby for 9 hours. In that 9 hours as she was waiting, she felt like she had to go to the bathroom. She was then wheeled into the bathroom and started passing blood. It wasn't coming from the urethra. It must have come form the vagina, she doesn't have a uterus. There were clots. She started passing blood in her urine but most was in the vaginal area but she has already had a hysterectomy. She was passing clots and her doctor who works in the healthcare field looked at it and said they were clots. Very shortly after, she passed the clot and the pain went away. The pain was passing clots/were clots/in the vaginal area at one point went away but she still have nausea and diarrhea and they gave her more fluids and sent her home. They didn't really want to address the vaginal bleeding. Patient have not been back and was not sure if she is still dehydrated. Patient was still pushing fluids and still not back to normal. Patient's daughter told her that since it was 5 days later it was not a reaction. Patient was thinking maybe it was an allergic internal severe reaction. Patient was weighing 130 pounds but lost about 4 pounds during this illness, so 4 pounds lighter. She stated her daughter-in-law was doing research and found a blog and there are woman the caller's age complaining of these symptoms (unexplained bleeding) after the vaccine. She asked if this was from the vaccine. She stated she was so sick that if there is even a chance then she doesn't want the second dose. She asked if this is a coincidence or has it been reported. She stated she is trying to make a decision on if she should get the second dose because she heard other people have symptoms and take the second shot. The outcome of the events passing clots/were clots/in the vaginal area, headache, a sharp pain in her side, passing blood in her urine, passing clots/were clots/in the vaginal area/vaginal bleeding was recovered on Apr2021, while for the other events, it was unknown.

Extreme go.lying and nausea, dehydration, couldn't keep down medicines, went into altered state, kidney failure heart and was in Hospital for March 31 - April 7, was not conscious until.April 5th. Some dr blamed it on the morphine but have had past unconscious hospitalization when sudden withdrawal from gabapentin which resulted from vomiting. Have never had problem with heart kidneys or lungs before this. Was given (medication) three times but it didn't bring me back to normal. As for level of morphine sudden stoppage of gabapetin CA affect the levels in blood. I was told not to get the second vaccine but not one dr in hospital seemed to want to report this and I don't think its right. I am going to have bill from being in intensive care and who knows what this will cost me.

This is a spontaneous report from a contactable consumer (patient) and a physician. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 in the afternoon around 2 or 3 o clock (Batch/Lot Number: EW0153) as 2ND DOSE, SINGLE for covid-19 vaccination. The vaccination was done in her building, a medical team came to them. She lives in subsidized housing. The patient's medical history included tendonitis; juvenile idiopathic arthritis from Dec 1969 and ongoing; lupus nephritis from 1989 (diagnosed ten years after SLE); systemic lupus erythematosus (SLE) from Dec 1979; discoid lupus; proliferative kidney disease stage 3; sjogren's; raynaud's; arthritis (since she was 13); bursitis; oral necrosis (this was from being on a calcium drug that they give menopausal women, it was out of her head right now when reporting. She could not think of the name. The drug was supposed to promote bone growth and keep her from getting osteoporosis); menopausal (because of chemo she started menopause at 42); vulvar lichen sclerosus; filamentary keratosis from 2015 and ongoing (this was since either Feb 2015 or Mar 2015); kidney cysts(one is benign and one is being watched); liver hepatic hemangioma; allergies (Allergies to aspirin, penicillin, dextrose IV, Biaxin, Levaquin, Cipro, band-aid adhesive, zofran, sulfa topical. The sulfa is a topical as opposed to being the sulpha with a ph.); adeno conjunctivitis from Jan2015 and ongoing (she had a really bad case of this in JAN 2015 and had to quarantine for three weeks. She lost her vision, she could not see for three days. She got a fever. It left her with a filament thing. It is just delightful. It is viral and really bad. She got it at her eye doctors office when she was there for an annual visit. She sometimes had to go there 3 times to have filament growing on her eye scrubbed off. It is wicked painful. It is quite an adventure.); she used to be three quarters but she shrunk a little; has been a couch potato for a year, it comes with the territory with lockdown and being depressed; she is immunocompromised and catches many things and is high risk She feels like a sitting duck; had issues on her palm of hands; had issues on her breasts, and chest; and various problems. Family Medical History Relevant to adverse events was none. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No other vaccines administered on same date with the Pfizer vaccine considered as suspect. Concomitant medications included vitamin b complex (B-COMPLEX 100) 100 as dose did not clarify units, has been on for years; hydroxyzine embonate (HYDROXYZINE PAM) Dosage 25 mg, she did not remember indication, may be allergies, if she is around a cat, she takes it prophylactically; acetylsalicylic acid (ASPIRIN) low strength, 81 mg twice a week, has been on for decades, nephrologist put her on it in the 90's and She did not remember why, he said it preserves kidney function or it is good for overall health; pentoxifylline ongoing at 400 mg, 3 a day, she has been on for years, her vascular doctor prescribed; prednisone dosage:1 mg, she takes and alternates between 6 and 7 mg, If she takes lower than that, she is a "narcoleptic" (as reported, did not clarify); rosuvastatin Dosage:10 mg, frequency not specified, it is a nightly thing; fish oil (SUPER OMEGA 3) overall supplement that was suggested by former nephrologist at some point some; estradiol (YUVAFEM) Dosage:10 micrograms for menopause, vaginal dryness; there was no variable in her medication routine, she is on a long list of medications (she could not remember, one was blood pressure, with the last administration she was worked up and her blood pressure would not come down, she also takes Tylenol as needed), she provided the details as she knows them, but did not know full details for all of her medications. There was nothing new to her routine except like when Prilosec was taken off the market, she got a different medication for it. She has been on all of these for long term maintenance. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19MAR2021 (at the age of 64-year-old)(Batch/Lot Number: ER2613) for covid-19 vaccination, adverse events following prior vaccinations: none; and flu vaccine for immunization in last fall, 2020. She has a history of obscure side effects to medication, things that people have never heard of and she is the 1 in a million that has ever had these problems. The patient previously took ondansetron (ZOFRAN), ("a chemotherapy treatment", given before chemotherapy), which gave her a homicidal migraine and they had to give her ice packs for her head; 9 rounds of "Cytox" (Cytoxin or Cytoxan) she was not sure how this was spelled, and chemotherapy (9 rounds of chemo); azathioprine (IMURAN), she does not know if it was spelled Immuran or Imuran; prednisone a number of years and she said to her rheumatologist, "it did not make sense on an intellectual basis that the prednisone being effective in her body as it was once" and he said he would give her IMURAN which is given to kidney patients to cause less of a reaction with the organ, and patient mentioned she had barely an immune system after all these years on prednisone, she went through 3 rounds of steroids; Heparin IV, which made her arm feel on fire on the inside, which they would not give her a flush when she had IV treatment; Dextrose IV made her skin feel hot and itchy, her mouth felt like she put something in that had been soaking in rubbing alcohol; ciprofloxacin (reported as "Cipro"), she had a bad reaction to Cipro, she was given after she was bit by a dog on her calves, she knew it was attached to and is "hurting her calves the rest of her life/the podiatrist said if it has not gone away, she is kind of stuck" (as reported, not specified). The patient just wanted to give Pfizer a full picture of what she was dealing with and she is an unusual case. She added that chemo was in the 90s and that is when all of the medication reactions she mentioned were. She absolutely does not have any of the information about the products she mentioned she had previous reactions to. Every time they did "this", it "hurt" and she asked them not to do it anymore. She asked them to not do dextrose anymore with the chemo because it feels like it is on fire, and she asked them to mix it with saline. She did not have any additional information, did not have the NDC, LOT, expiration date, or manufacturer for any of these medications she reported historical adverse events on. The patient reported that she got her 2nd shot of the Pfizer covid vaccine on 09Apr2021. She has soreness at the site, more-so several hours after getting the vaccine (09Apr2021). Just her arm felt sore within moments after the second vaccine, but she did not get this after the first. She rested and took it easy that weekend. There was Sore, Tired, general lethargy, and fatigue (Apr2021): when she looked online, it really only told her what everyone knows about that you might be sore and tired and she had all that, she thought she was through with all of that. She had no chills, just general lethargy and fatigue. She was sluggish and tired and not herself that weekend (Apr 2021). She stayed home so it is difficulty to say. Her arm was definitely sore. For sluggishness and fatigue, she said that she has been a couch potato for a year, it comes with the territory with lockdown and being depressed, so it is difficult to decide if it is health or physically induced or a emotional base. She did not knowingly spike a fever, no chills or sweats. And on Monday (did not clarify dates but states it was Monday after 09APR2021, throughout the weekend she took it easy), she noticed with her foot, she had difficulty getting out of bed could not put weight on her right foot. She was alarmed. She stayed home and rested and did a lot of napping and taking it slow. It is still difficulty and moving certain ways hurts more if she flexes. She has a known history of tendonitis so she wore her brace in the meantime. She thought maybe she had tendonitis in both ankles and this was similar so maybe it was a different set of tendons. She would wear a brace, and eventually it will get better in time. She also was wearing braces like compression socks that toes stick out of. She thought she had tendonitis and that is what she has done in the past. It has been a month and she is not better. This was her left foot, most of the pain was focused on the sole of her foot towards the outer edge. That is where it started. Then it migrated over time. That was weird and had her worried. It was all in her arch in the initial spot. She notes it is not like the tendonitis she had the first time. She does not want to be an alarmist or have her doctor think she is a hypochondriac she waited. She was then rubbing her foot, the right one, and noticed it was tender on the top of her foot just like the left one. There was sore. There was pain in right foot, pain in feet. Pain in feet, her left foot had most of the pain on the top and bottom and a lot of it is along the outer part of her sole of the foot. In her right foot, the pain is mostly at the fleshy part below her toes and on top of her foot. The pain moved around into the other foot for about a month so she went to the podiatrist yesterday (06May2021) and doctor did x-rays. The night before (05May2021), the opposite leg had a line of black and blue dots on her right calf that went up her leg, she did not notice this until Wednesday (05May2021) evening because she never examines it. She soaped up a washcloth and she knew where her parts are in the bath. Her mind wanders and she was not looking. She happened to be wearing something where her legs were not covered and that is how she knew. It did not hurt. It was strange, looking like bruising in a line. The doctor said it was all like one vein and he cold feel it. She can not feel it, but he could. The doctor told her these could be clots. She still has them. Doctor said the other leg where she had the pain was only soft tissue pain. Doctor found that every place that hurt when he touched it and it still hurts where he had touched it. She was told she does not have arthritis and she has had arthritis since she was 13. The doctor did not know what it is. It was her left foot constantly, and the right foot hurt off and on during that period. The left for sure was kind of a dull ache and throbbing. The right was only a little bit. The left was worse. It appeared to be soft tissue that was hurting and he said there are so many side effects of this new vaccine and to maybe try heat or ice. Ever since the patient left doctor's office until now (the time of reporting) she did not known if she need to be concerned, that if she does not know what it is, can ice or heat make it worse? She did not know the next steps. Treatment, she tried to keep it elevated because that can not hurt but that is about it. She has not done heat and ice because if the doctor does not know what it is, how does he know it will not make it worse. He asked if she could take aspirin and she said no she is allergic to aspirin. Tylenol she does not take often, only when she feels like she needs it and she has not been doing it often. When she stays off it, it does not hurt as much as when she is walking. She wanted to know if she should be worried and she wanted to add (report this) to the database if this is a side effect and if Pfizer has ever heard of this before. There was also tired, general lethargy, and fatigue. At this point when reporting, she is single and lives alone, and said that "God forbid something happens, there is nobody to say let's get you to a hospital". She heard about blood clots on the news. When they said blood clot yesterday, it was a red warning light going on and a siren. At the time of reporting it was Friday and she did not know that if she need to rush to the hospital. Her primary care physician (PCP) said she had never heard of this and to call Pfizer. The patient asked if she is one of a small group of people this has happened to. She asked if she should not worry and it will go away or should she get to a hospital. She thought she had a problem with her feet (foot problem) but her podiatrist does not know what was going on. She communicated with her physician office today and she said she has never heard of this. She wanted to know if her symptoms have been heard of and if she should go to the hospital. The events did not require a visit to emergency room. The patient underwent lab tests and procedures which included: height as "5 and three quarters of an inch feet (5'0.75")" on an unspecified date; rapid COVID-19 test on 06May2021: negative; regular COVID-19 test on 06May2021: negative; x-ray on 06May2021 to make sure she did not break anything: unknown results. She also went because she had not done it in a year and she had something from the health department saying to get tested weekly for the virus (clarified that she was talking about the COVID tests as what she went and got done). The outcome of the events was unknown.

mild sepsis; It was normal, except her bladder, because it was so swollen she felt like she couldn't empty it completely; swelling in her brain; thyroid felt swollen; gained 10 pounds overnight of fluid.; lymph nodes got huge; headache; Her tongue feels swollen; Pain in all her organs; Her arm was so sore/ sore left arm; so she had it put in her left hip/ sore left hip. It was sore for about 2 weeks; gained 10 pounds overnight of fluid. Her kidneys, bladder, intestines, stomach and she felt swollen and her liver too; affected her brain and speech/difficulty pronouncing words; Affected her brain and speech; allergic reaction; experienced a personality change; feeling puffy; felt like she had a tourniquet around her neck/Her organs felt swollen; cognitive issues; Throat swelling; pain in the part of her liver; couldn't remember where she put things; muscles did not work right; bladder infection; She was so cranky; Intense stomach ache; This is a spontaneous report received from a contactable consumer (patient reported for herself) from a Pfizer- sponsored program. A 64-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 08Apr2021 at the age of 64 years old (Lot Number: ER8732) as 2nd dose, single for covid-19 immunisation. Medical history included Cancer: Gerson Therapy; Autoimmune disorder; allergies ongoing; Parvovirus B19: exposed to Parvo B virus, it's called the 5th Disease, she had a rare reaction to it and it gave her Rheumatoid Arthritis ongoing, Fibromyalgia ongoing, Multiple Sclerosis ongoing and Behcet's like overnight; allergies to food (she got swelling, intense depression, suicidal tendencies, and a fight or flight response), drugs (Tylenol and Aspirin, basically any pain killer, Percocet and Darvocet), air, dirt, trees, and bugs. It runs in her family; inflammation. Concomitant medications included ongoing fish oil (FISH OIL); ongoing curcuma longa (TURMERIC [CURCUMA LONGA]); several other supplements; ongoing Benadryl for allergies when need. The patient previously received the first dose of BNT162B2 on 19Mar2021 09:00 at the age of 64 years old (lot number: EN6207) in Left arm for Covid-19 immunization and experienced allergic reaction, throat itchy, numbness on her left side/ Legs were like spaghetti and she felt like the scarecrow in Wizard of Oz, lungs itchy and inflamed, coughing, barking asthma cough, Speech slurred, Oxygen level felt like it was in the 80s (80%), muscles not responding, Crooked walk, died 6 times and experienced an out of body experience. Vaccination Facility Type was Hospital. Vaccine was not Administered at any Facility. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Caller wanted to know about the need for booster dose; Was it going to be like the first or second dose of the vaccine. Caller wanted to know the ingredient of the Pfizer covid vaccine. She said she took both of the doses and had a bad reactions from it. Caller stated she had a lot of issues with the first dose but not as bad as second dose. The second dose almost killed her and affected her brain and speech. She had the Pfizer Covid-19 vaccine, and experienced a bad reaction after both doses. Caller asking what was in the vaccine that could cause her bad reaction. She never had a reaction to any vaccine. She had allergies and autoimmune disorder. Her arm was so sore/ sore left arm the first time. It was difficult to get in and out of car for 3 weeks, but she recovered completely. She helps the handicap people, so she had it put in her left hip/ sore left hip. It was sore for about 2 weeks, but she recovered completely. Caller added she needed to decipher what was written on the vaccination card. She wished they would write better. She used her glasses. Caller took no pharmaceuticals, just Benadryl for allergies when need. The Hospital where she received her vaccine was used and created by another facility, but not a an offsite facility. But for them to use also. Caller added she was cured of everything she had from the Therapy. After the second dose: She started same day as vaccine on 08Apr2021. She did her protocol that time, and as far as breathing and that, it was not like the first dose, but towards the evening she had an auto immune response that lasted for 3 weeks. She felt like she experienced mild sepsis and gained 10 pounds overnight of fluid. Her kidneys, bladder, intestines, stomach and she felt swollen and her liver too. When this happened it started with feeling puffy that evening and lasted for 3 weeks. Caller added if she was exposed to a virus, or had an allergic reaction this happens. Caller added even her lymph nodes got huge and thyroid felt swollen, felt like she had a tourniquet around her neck. That lasted for 3 weeks. It was bad the 1st week. That caused a severe headache that started on the 3rd day and lasted 4 days. It was really bad on the 1st day and she wanted to go to the Emergency Room. She took Benadryl and Ibuprofen, and a Doctor told her she shouldn't take Ibuprofen because of Covid. She was allergic to Tylenol and Aspirin, basically any pain killer, Percocet and Darvocet, Everything except Ibuprofen. Caller did not have the bottle to provide details. She usually put Ibuprofen in her Benadryl bottle for her inflammation. That was the only thing that she took. She took Turmeric and fish oil and several other supplements. Her headache peaked on the 4th day, and she took the Ibuprofen and was better the next day. Throat swelling started on the 5th day and lasted and was still causing her difficulty pronouncing words. Her tongue felt swollen. Her cognitive issues started the 4th day of her headache and was intense. It continued, but was much, much better. She did her normal protocol, and had gotten by, but it was not normal. Her organs felt swollen and the doctor did a test. It was normal, except her bladder, because it was so swollen she felt like she couldn't empty it completely. The muscles did not work right and she got an bladder infection and received antibiotics, about 2 weeks after the injection, because her bladder wasn't working right. Urine test: infection. Intense stomach ache: started at the time her headache stated after 3 days along with the headache and ended with her doing the Therapy. They lasted for 4 weeks. Pain in all her organs: started the 3rd day after the second dose. The pain started, she felt swelling and it lasted for 3 weeks, actually, for 4 weeks, the pain in the part of her liver by her stomach. She experienced a personality change and she wouldn't have the vaccine again. She couldn't remember where she put things, started on the 7th day after her second dose and lasted until the Therapy made her feel better. Finally, after 4 weeks, she recovered completely and was pretty much back normal now. Caller added she was a happy person and was with her Cancer. People asked how she did it. But with this experience she literally wanted to hurt someone or kill herself, and no it was not normal. She was so cranky. She was sure it was the swelling in her brain. With her food allergies she got swelling, intense depression, suicidal tendencies, and a fight or flight response. She wanted to leave her life, it was scary. Caller added she did not feel like this now. For the Vaccine Indication: Caller added that people that need it most, didn't want it. Because of her autoimmune disorder, she was a long huller and she had died 6 times, so she was willing to try it and take it and deal with the side effects. She was hoping it would not cause any. Her boyfriend died at Christmas. After 24 hours he was dead. He had a mild sepsis from a virus. He has Autoimmune disease. If she got Covid, she didn't want to end up like him and see her arms and legs amputated. Caller asked if anyone else had reported symptoms she had experienced. Caller asked to clarify details of her symptoms of suicide and killing and hurting others. Caller denied she was experiencing this at time of call. Therapeutic measures were taken as a result of events headache, Personality change, couldn't remember where she put things, bladder infection. The outcome of the events Pain in arm, Pain in hip, Personality change, couldn't remember where she put things, Stomach ache was recovered on an unspecified date, of cognitive issues was recovering, of the other events was unknown.

Patient received one dose of Pfizer COVID-19 vaccine on 3/24/21, but became ill with a non-COVID infection prior to receiving the second dose. She attempted to waited until her antibiotic course was completed before attempting to reschedule her second dose but became ill with COVID-19 before receiving dose 2. She became ill with COVID-19 symptoms on approximately 5/10/21 and felt ill enough to require an ED visit on 5/24/21. From there she was admitted to the hospital for 3 days with discharge on 5/27/21. She received dexamethasone, tocilizumab, and supplementary oxygen during admission. Patient was discharged with dexamethasone and supplemental oxygen (2L). The patient returned to ED on 5/28/21 stating she is having increased O2 requirements and is unable to care for herself at home. Patient is being admitted and continued on supplementary O2 and dexamethasone.

Please note the patient did not receive the vaccination at state Medicine so the lot # and site of administration information is NOT available. Unclear if vaccine contributed to patient condition or outcome, but reporting due to timing of events. Patient received her 2nd Pfizer COVID vaccine around 2 pm on 5/19. She felt fatigued and had some localized arm pain in the arm she received her shot. She returned home and took a long nap from 3:30 pm to 11 pm at her daughter's house. She was playing with her grand-daughter and lifting her up when all of a sudden the daughter and her daughter's husband noticed the patient made a grunting/choking noise. She all of a sudden became unresponsive, had fixed pupils and a blank stare and found to be in PEA arrest with acute respiratory failure. Patient was initially admitted 5/20 to Medical Center and then transferred to state Medicine on 5/21. Patient passed on 5/31/21.

Cough Fatigue Headache Sore throat Office Visit 5/20/2021 PA-C Family Medicine Other form of dyspnea +1 more Dx Cough Reason for Visit Progress Notes PA-C (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 5/20/2021 ? ? Signed Cosigned by: MD at 5/31/2021 7:50 PM Expand AllCollapse All MDM 1. Other form of dyspnea 2. Chest pressure History and physical exam consistent with chest pressure with dyspnea. EKG shows nonspecific T wave changes. Although I see no acute ischemic changes, she does have risk factors for heart disease and is complaining about worsening dyspnea on exertion and I therefore encouraged her to go to the emergency department for blood work to verify that this is not cardiogenic. Symptoms could likely be due to her respiratory illness but given her history of hypertension and family history of heart disease, feel a set of troponins is indicated. Patient is agreeable and states she will go to emergency department. She does have her sister with her who is driving. Patient does not appear to be toxic or dehydrated and vital signs are stable. 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/family member 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. Discussed antibiotic stewardship as appropriate Careline information discussed and included in AVS. Patient was seen today for cough. Diagnoses and all orders for this visit: Other form of dyspnea - X-ray chest 2 views; Future - ECG 12-lead: URGENT CARE (Here and Now) Chest pressure History Chief Complaint Patient presents with ? Cough productive cough with white sputum, diarrhea x 7 days, today is day 10 since COVID positive dx and not getting better ED Discharged 5/20/2021 (1 hours) Hospital ER MD Last attending ? Treatment team Pneumonia due to COVID-19 virus Clinical impression Shortness of Breath Chief complaint ED Provider Notes MD (Physician) ? ? Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with ? Shortness of Breath HPI 64 y.o. F p/t ED for cough SOB diarrhea and CP. Has history of hypertension. No smoke history. No lung disease history. She has had 10 days of symptoms. Tested positive for COVID-19. She was vaccinated. She works as a respiratory therapist as an outpatient performing PFTs daily. Symptoms have not gotten any better and she started feeling short of breath over the last 2 days. She had mild cough, productive. No leg pain or swelling. No history of DVT or PE. Seen at urgent care and found to have EKG with nonspecific T wave changes so sent to the ED for further evaluation the light of her chest pressure. Chest pressure and shortness of breath are worse with ambulation and activity. No fevers. Has had some chills. Loss of taste and smell. Chest x-ray obtained an outpatient was demonstrated to some patchy infiltrate in the right lower lobe.

On 3/20/21, patient was seen in ER. Patient with c/o chest pain, body aches, fever, diarrhea, vomiting blood, and "pain from head to toe." Patient transferred and diagnosed a heart attack with cardiopulmonary shock. Patient received heart catheterization. On 5/2/21, patient again seen in ER at for SOB and low blood pressure. Patient again transferred to. On 6/4/21, patient was seen by family practitioner. Patient c/o pain to medial joint line of left knee.

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

Patient went to the emergency department with generalized swelling and was diagnosed with congestive heart failure

AFib; heart attack; low platelets; GI bleed; This is a spontaneous report from a contactable consumer (patient). The 64-years-old female patient received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 12:00 (Lot Number: ER8730) as single dose for covid-19 immunization at the age of 64 years old; avatrombopag maleate (DOPTELET), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for an unspecified indication. Medical history included ITP from 1987 and ongoing. The report was not related to a study or programme. No Investigation Assessment. The patient's concomitant medications were none. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient experienced gi bleed on 25Mar2021, afib, heart attack, low platelets on an unspecified date. The patient was hospitalized for gi bleed from 25Mar2021 to 27Mar2021 and hospitalization details for the rest events were not speicifed. Reported as: Caller states she has ITP, so this means she makes antibodies that destroys her own platelets, her doctors told her to go ahead and get the Pfizer Covid vaccines, states she got the first dose of the Pfizer Covid vaccine on 22Mar2021, states three days later on 25Mar2021, hospitalized with a GI bleed and low platelets, states after that she was hospitalized three more times. States the first three were low platelets, states during second hospitalization she went into Afib and during the fourth hospitalization she had a heart attack due to the Afib. Caller states she was treated with immunosuppressants, IVIG, rituximab, an anti rejection medication called Cellcept to get her ITP under control. States the medication she was taking didn't seem to be working anymore. Medication was Doptelet, was on this prior to vaccine, does not seem to be controlling her ITP anymore after receiving the vaccine. States she is not completely recovered but is on the mend now. The AEs require a visit to Emergency Room. Caller confirms she did not receive the second dose of the vaccine. The action taken in response to the event for avatrombopag maleate was unknown. The outcome of the event gi bleed was recovering and was unknown for the rest events.

A week after the vaccination I had fever of 103 and chills that was going away. I went to the doctor and was given an Echocardiogram (04/13/2021) where it showed I developed pericardia infusion. In June I went for a second Echocardiogram is it was less than what it showed in April.

She started to feel very sick almost immediately after taking it. She wasn't herself (according to her husband, aka my girlfriend's dad) and she died on March 20th, 2021. Yet somehow the EMT had the nerve to try and pretend it wasn't because of the experimental mRNA thing you guys call a Vaccine.

Had a stroke on may 1. Symptons were not severe and defined so medical help wasnt sought until may 3. Luckily stroke apparently was considered minor

Patient has been diagnosed with DVT blood clot in left lower leg. Patient is now on a blood thinner to attempt to dissolve the clot. Patient has no personal or family history of blood clots.

The patient received her COVID vaccine on March 17, 2021 at a local clinic. She developed bruises within days after the shot. She pursued care and diagnosis and reporting with the vaccine administrator, but finally had to see PCP. After multiple visits, the patient was sent to Hospital. She was diagnosed with AML (hospitalized 5 days: April 6-10) and started chemotherapy (outpatient on April 19). She returned to hospital on April 25 in distress and diagnosed with COVID. The patient was put on a ventilator with pressor support on May 1 and passed away on May 10, 2021.

A-fibalation 27 hours after vaccine. No prior history of a-fib or any heart issues. Started at hospital 7/13/21, ambulanced to other hospital twelve hours later, released 7/16/21.

DX: Pericarditis S/S: Lethargy/fatigue, Dyspnea on exertion, dyspnea with lying down or orthopnea, edema, anorexia or poor feeding, tachypnea, acute chest pain or pressure Clinician description:3-4 weeks of progressive shortness of breath and dyspnea on exertion. Typically sleeps propped up on 3 pillows, no new orthopnea or nocturnal dyspnea. History of sleep apnea but intolerant of CPAP S/S onsetn: 03/26/2021

diagnosed with AML; passed away on 10May2021; diagnosed with COVID; diagnosed with COVID; developed bruises within days after the shot; This is a spontaneous report from a consumer. This consumer (patient) reported for herself that a 64-years-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, lot number: EN6207), via an unspecified route of administration in left arm on 17Mar2021 (at the age of 64-years-old) for COVID-19 immunisation at Public Health Clinic. The patient's medical history were hypertension, rectocele, migraine and diverticulitis; all were from an unknown date and unknown if ongoing and had back pain from accident in 2011. Concomitant medications included Flexeril (cefixime), Topamax (topiramate), Maxidene (piroxicam), Centrum Silver (ascorbic acid; biotin; boron; calcium; calcium pantothenate; chlorine; chromium; colecalciferol; copper; cyanocobalamin; folic acid; iodine; magnesium; manganese; molybdenum; nickel; nicotinamide; phosphorus; phytomenadione; potassium; pyridoxine hydroch) and Norco (hydrocodone bitartrate, paracetamol); all were for an unknown indication and received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Mar2021, the patient developed bruises within days after the shot. She pursued care and diagnosis and reporting with the vaccine administrator, but finally had to see PCP. After multiple visits, the patient was sent to Hospital. On 06Apr2021, she was diagnosed with AML (hospitalized 5 days: 06Apr21 -10Apr21) and started chemotherapy (outpatient on 19Apr21). She returned on 25Apr21 in distress and diagnosed with COVID. The patient was put on a ventilator with pressor support on 01May2021 and passed away on 10May2021. Adverse event resulted in hospitalization for 23 days, Life threatening illness immediate risk of death from the event. On 25Apr2021, covid test (nasal swab) post vaccination was positive. The patient did not diagnose with COVID-19, prior to vaccination. The patient was not tested for COVID-19, since the vaccination. The patient received treatment as chemotherapy for adverse event. The outcome of the adverse event was not recovered.; Reported Cause(s) of Death: passed away on 10May2021

Resident found unresponsive without pulse, respirations at 04:30 CPR performed, expired at 04:52 by Rescue

Chief Complaint: low blood pressure, tachycardia, SOB after last Friday's Covid shot. Pt. meeting SIRS criteria with elevated lactate, WBCs, and tachycardia. Given fluid bolus and IV ABX.

I have been in Afib since approximately 2 hours after receiving the vaccine. I do have a diagnosis of Afib but am not currently taking medication for it. Until yesterday I have only periodic episodes.

Notified by a secondary source the following information. Patient was admitted to the hospital for a stroke. The hospital discovered the patient had a stroke a week prior to vaccination. Patient pace maker had been faulty and patient INR may have been lower than therapeutic. Unable to speak directly to patient at this time to confirm these events. Actual progression unknown. Understood patient is improving.

Suffered a massive MCA stroke; This is a spontaneous report from a Contactable Nurse. A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), intramuscularly in left arm on 12Jan2021 16:00 at single dose for COVID-19 immunization. Medical history included covid prior vaccination. Known allergies: None. The patient's concomitant medications were not reported. The patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EJ1685), intramuscularly in right arm on 21Dec2020 03:00 PM at single dose for COVID-19 immunization. The patient was not pregnant while receiving vaccine. Facility type vaccine: Hospital. If other vaccine in four weeks: No. Other medications in two weeks: No. The patient suffered a massive MCA (Middle cerebral artery) stroke on 21Jan2021 08:00 after getting second covid vaccine with outcome of not recovered. No history of hypertension, elevated cholesterol or medical issues. No medication being taken. Daily BP (Blood pressure) reading normal. Covid test post vaccination: Nasal Swab-PCR on 22Jan2021 with result negative. If treatment for AE: Unknown. The event was resulted in: Emergency room/department or urgent care, Hospitalization (Number of days hospitalization: 4), Life threatening illness (immediate risk of death from the event), Disability or permanent damage.; Sender's Comments: The event middle cerebral artery stroke appeared 8 days after administration BNT162B2. The Company considers that the event is less likely related to suspect BNT162B2 injection given the weak time association. The status (bleeding or infarction) and cause of the stroke would be helpful for further assessment. 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.

I had anaphylaxis yesterday; Throat is still swollen; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunisation. Medical history included diabetes mellitus. Concomitant medication included metformin (unknown manufacturer), levothyroxine sodium (LEVOXYL), fluoxetine (unknown manufacturer), empagliflozin (JARDIANCE), rosuvastatin (unknown manufacturer). The patient experienced anaphylaxis and throat was still swollen on 15Jan2021 about 30 minutes after when she received the shot, with outcome of recovering. The patient was transferred to emergency and was treated for the event.

Starting on 1/17/21 had fever of 101.6, 1/18/21 fever of 101.2, 1/19/21 fever of 102.6. From 1/19-1/23 she had defervesed to normal temp. Afternoon of 1/23/21 temp 101.4, 1/24/21 fever of 103 and 101. On 1/25/21 the nurses called the doctor and said that she was lethargic. Dr. found her to be hypotensive, lethargic, tacchycardic, They sent her to the ER. She also had during that day they found her with neck pain with movement, chills and fever. From 1/25-today she is still admitted to the hospital. They found her to have staph aureus sepsis - source unknown, encephalopathy related to sepsis, they did rule out meningitis, hyponatremia, UTI with E-coli and some staph, urinary retention, rhabdomyalisis with acute kidney injury and dehydration. They are treating her with antibiotics, getting better but still hospitalized.

Within 12 hrs of receiving the vaccine the pt began to experience generalized weakness, chills, shortness of breath with symptoms worsening as time went on. Pt remained afebrile. Pt presented to the ED and was diagnosed with a Pulmonary Embolism.

my body collapsed and I had a Pulmonary embolism/I have clot in my lung; I have behind my knee like a deep wide black spot and it is hard; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medication included amlodipine, metformin and propranolol. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization and experienced severe headache and diarrhea. On 13Jan2021, the patient reported that: "my body collapsed, I had a pulmonary embolism. I had to go to the hospital in ambulance. When I was there, they find out that I have clot in my lung. I was in an intensive care for 2 days or 3 days and about 5 days in the hospital (from 13Jan2021 to 17Jan2021). I have behind my knee like a deep wide black spot and it is hard, my body did not have anything like that". Therapeutic measures were taken as a result of event pulmonary embolism/ clot in lung and included treatment with "some medications", one of which ELIQUIS. The patient outcome of pulmonary embolism and "clot in lung" was recovered on an unspecified date and of deep wide black spot was unknown. The information on the batch number has been requested.

Patient found unresponsive in room with no pulse or respirations. She was pronounced dead by paramedics at 06:25am on 2/5/2021.

Patient developed shortness of breath and irregular heart beat 8 days after receiving immunization. Presented to the Clinic and was sent to the Emergency Department for evaluation. Admitted for PE, NSTEMI, and afib with RVR 2/11/21. Discharged to home 2/12/21.

anaphylactic reaction; having issues breathing/didn't have normal respiratory support; swallowing, weakness, unable to take anything by mouth/had lost ability to swallow; swallowing, weakness, unable to take anything by mouth; affected my lungs, gut, muscles, everything.; still having lung issues; This is a spontaneous report from a contactable consumer(patient). A 65-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number RM9809), via an unspecified route of administration on 03Feb2021 at the 65 years old at single dose for COVID-19 immunization. The medical history included Muscular dystrophy. The concomitant medications included unspecified multiple medications. The patient received the first dose on 03Feb2021. Immediately after the vaccine on 03Feb2021 she had an anaphylactic reaction, received an Epipen, went to the ER was given steroids and sent home. Next day, still having symptoms, received second Epipen administration, went to Urgent Care, was admitted to hospital 04Feb2021. The patient stated she had a history of muscular dystrophy. She stated she was having issues breathing, swallowing, weakness, unable to take anything by mouth, didn't have normal respiratory support in Feb2021. It had affected her lungs, gut, muscles, everything. She may leave here on hospice. She wanted to know if there were others who had reported side effects such as hers. She had anaphylactic reaction to the mineral. She was still in the hospital. She had lost ability to swallow and she was still having lung issues in Feb2021. She was a disabled rehab healthcare worker. She did not have an address right now in the hospital but if sent her something later once she get out she will be able to do that but she did not have it now. She takes multiple medications. Right now she cannot take medications she need orally. She had gone to hospital getting meds via primarily IV. She had acute anaphylactic reaction immediately after the vaccine and went by ambulance to hospital and was given steroids, care basically and sent home and she still had issues the next day and it kept going from home to urgent care to admission at the hospital. She had done lot of lab tests in Feb2021. She was very concerned that this was not going to be a temporary issue. She had form of muscular dystrophy and now what was happening was the week before she got the vaccine totally independent in her home, feeling ok, medications okay and now she was at IV medications not being able to swallow. She talked to someone yesterday and they told she should be calling and reporting what happened and that was why she had been on the phone all day. She just want make sure she did not feel like the healthcare was reaching out to their own vaccination department and she want to make absolutely sure that not only does Pfizer know that have a horrid reaction but she want the healthcare firm that she had a horrid reaction and she want the CDC to know that she had a horrid reaction because right now she would tell all her friends with the severe form of muscle dystrophy she had not going to be vaccinated even though the researchers were telling her to get vaccinated. It was going to take a while to stop the efficacy again and having to be on the phone everyday when she was barely breathing. The patient underwent lab tests and procedures, which included Lab test unknown result in Feb2021. The outcome of the events was unknown.

blew a blood vessel under her eye lid; stroke; tasted rubber band taste in her mouth; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), in a clinic, intramuscularly in the right arm on 29Jan2021 at 14:00 at 65-years-old at a single dose for COVID-19 immunization. There were no prior vaccinations within four weeks of the bnt162b2. Medical history included ongoing fibromyalgia from an unknown date, reflex sympathetic dystrophy from an unknown date and unknown if ongoing, irregular heart beat from an unknown date and unknown if ongoing, ongoing hemangioma from an unknown date, thyroid problems from an unknown date and unknown if ongoing, low white blood cell counts from an unknown date and unknown if ongoing, ongoing pinched nerves in her neck and back from an unknown date, migraines from an unknown date and unknown if ongoing, diastolic heart failure from an unknown date and unknown if ongoing (diagnosed about 5 years ago.), abdominal pains from an unknown date and unknown if ongoing, numbness in her nose, foot from an unknown date and unknown if ongoing, nausea from an unknown date and unknown if ongoing, vomiting from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL1283) for COVID-19 immunization on 08Jan2021 at 64-years-old and experienced metallic taste (Recovered), carbamazepine (TEGRETOL) from an unknown date to an unknown date and experienced white count was down to 1, influenza vaccine (MANUFACTURER UNKNOWN) in Jul2020 at 64-years-old for immunization. The patient experienced the following events and outcomes: stroke (medically significant) on 29Jan2021 at 14:10 with outcome of unknown, blew a blood vessel under her eye lid (medically significant) on 31Jan2021 with outcome of recovering, tasted rubber band taste in her mouth (non-serious) on 29Jan2021 with outcome of unknown. The clinical course was reported as follows: The patient reported a history of migraines/ weather migraines, that cause numbness in nose and foot as well as gastro-intestinal symptoms. The patient received her first dose of the Pfizer COVID vaccine on 08Jan2021 and felt a metallic taste in her mouth (said that the metallic taste lasted about three hours; ate to get rid of the metallic taste). On 29Jan2021, the patient received her second dose; after 10 minutes her face went numb; her nose, forehead, and under her eyes all the way up felt numb. Also, the patient's systolic blood pressure was at 150. The patient reported that she also tasted rubber band taste in her mouth. The patient's neighbor that was there with her getting the vaccine told the nurse and they called the paramedics. The paramedics stated that they thought she had a stroke. She said that her blood pressure was 150 systolic (usually 107-110/79). The patient had diastolic heart failure which was diagnosed about 5 years prior. The numbness stayed with her until about 22:00 on 29Jan2021. The patient had a history of "migraines and gets abdominal pains, numbness in her nose, foot", and she experienced "nausea and vomiting and stuff with her migraines." The patient thought the vaccine just gave her a big migraine. The patient took sumatriptan succinate (IMITREX) and it did nothing. The patient said that on 31Jan2021 her eye felt weird. The patient blew a blood vessel under her eye lid. The patient's eye looked like a blood clot in the corner of her eye then it dispersed throughout the eye and then now it was just below the pupil of her eye. The patient called the doctor on 01Feb2021, but they were out because of the snow. On 02Feb2021, the patient received a call from the doctor's office saying that the physician assistant would call her back, but the patient had not heard anything yet. The blood circulated around her eye and now it was just only under her pupil. The patient said that her daughter sent her something that said that some people have gotten Bell's palsy after getting the vaccine. The patient said that she was concerned about this with the facial numbness. The patient said that every once in a while, her face felt weird; her cheeks feel weird and her nose. The patient said that it comes and goes. The day after she got the second shot, she felt like she got run over by a truck and like someone beat her up. The patient's migraines were under control with magnesium. The migraine came on so quick it was like a boom. The patient said that was why she was concerned. The patient said that she declined going to the hospital; and there was no trip to the emergency room or physician office. The patient underwent lab tests and procedures which included blood pressure: 150 systolic on 29Jan2021 (usually 107-110/79). Therapeutic measures were taken as a result of stroke.

Diagnosed with May-thurner syndrome; Deep vein thrombosis; Both of her feet were only slightly swollen; Dull minor headache; Off-label use; Inappropriate schedule of vaccine administered; Localized discomfort where injection of second dose of Pfizer COVID-19 Vaccine was given; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient (weight: 77.56 kg, height: 157 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the upper left arm, on 23Jan2021, for COVID-19 immunisation. Relevant medical history included thyroid condition from an unspecified date (over 25-30 years before this report) and ongoing, controlled with levothyroxine sodium (SYNTHROID); and breast cancer from an unspecified date, in 2019 (treatment and surgery on an unspecified date, in 2019. Presumed resolved with radiation treatment, but no treatment within a year prior to getting Pfizer COVID-19 vaccine). The patient previously, on 05Jan2021 (18 days before the second dose), received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) for COVID-19 immunisation. After the first dose, the patient experienced localized discomfort at the injection site and swelling of feet. Concomitant medication included levothyroxine sodium (SYNTHROID) from an unspecified date and ongoing, 0.88 mg, daily, for thyroid condition. On 23Jan2021, the patient experienced injection site discomfort described as "localized discomfort where injection of second dose of Pfizer COVID-19 Vaccine was given". On 24Jan2021, she had dull minor headache. On an unspecified date, the patient was hospitalized after the second dose and was diagnosed with May-thurner syndrome. She clarified that May-Thurner syndrome was where the iliac artery collapses and crushed the iliac vein in the upper abdomen; from that point down it started creating a blood clot. She developed a deep vein thrombosis (DVT) from her left ankle up to her right rib cage area; it was a monster. On 10Feb2021, the patient experienced deep vein thrombosis and thrombectomy was performed on the same day (outpatient thrombectomy surgery, performed 10Feb2021. It was a great surgery, very corrective. She never did have any pain or discomfort which confused everyone. She felt fine this whole time, no issues). On an unspecified date, both of her feet were only slightly swollen. Relevant laboratory test, performed on an unspecified date, in 2021, included computerised tomogram (CT scan with contrast of her abdomen and chest) that showed deep vein thrombosis: left ankle-right ribcage area. The adverse events May-Thurner syndrome and deep vein thrombosis were assessed as serious, hospitalization required from 02Feb2021 to 10Feb2021. The patient recovered from deep vein thrombosis on 10Feb2021, recovered from headache on 26Jan2021, recovered from swelling of feet and vaccination site discomfort on an unspecified date, while clinical outcome of the other events was unknown. Her vascular surgeon said he did not believe these events were vaccine related but cannot rule it out; her Primary Care Physician absolutely believed the events were vaccine related. The information on the lot number has been requested.

Starting at bedtime, the patient felt itchiness at the injection site. The sensation started to feel so intense that it felt like her skin was crawling. Shortly after she developed a rash and with raised, red pustules. The scratching led to bleeding and eruption of the pustules. The sensation went away after a few hours and left small scabs that are now healing.

Pt passed away 15 days after vaccine, no indication death was related to vaccine. Narrative: Patient was a 64 yr old female with stage 4 serious ovarian cancer with extensive lung metastases no longer on treatment with severe CAD, HFpEF who was transitioned to comfort care on 1/23/21.

I have been diagnosed with Afib but do not have daily episodes. Within 2 hours after receiving the vaccine I began to have regular episodes throughout the day and night and they have continued.; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELB982), via an unspecified route of administration on the left arm on 25Jan2021 11:15 at a single dose for COVID-19 immunization. Medical history included heart disease, hypothyroidism and Afib (Atrial fibrillation). The patient is not pregnant. Concomitant medication included levothyroxine, acetylsalicylic acid (BABY ASPIRIN) and cetirizine hydrochloride (ZYRTEC). It was reported that the patient was diagnosed with Afib but do not have daily episodes. Within 2 hours after receiving the vaccine (25Jan2021 13:30), the patient began to have regular episodes throughout the day and night and they have continued. Her cardiologist is out of town and was referred by his office to go to the ER if she felt she should. The patient do not think it is bad enough to go to the ER so she is just monitoring on her Apple Watch. No treatment was received for the event. The outcome of the event was not recovered.

2/3 rehab visit: PA - 02/03/2021 12:25 PM CST Formatting of this note might be different from the original. NURSING HOME ACUTE VISIT 6/24/1955 MD SUBJECTIVE: Chief Complaint Patient presents with ? Cough Pt has COVID 19 and she is coughing and congestion. This is an acute visit with pt. Status and changes discussed with staff. Advanced directives on file. Allergies reviewed at NH, though may not be fully updated in electronic record. Problem List reviewed. ROS: Gen: Denies fever CV: Denies chest pain Resp: Denies dyspnea GI: Denies abdominal pain. GU: Denies dysuria. Psych: Denies depression. OBJECTIVE: VITALS: Vitals: 02/03/21 1226 BP: (!) 94/54 Pulse: 79 Resp: 18 Temp: 37 °C (98.6 °F) SpO2: 96% PHYSICAL EXAM: General: Alert, awake, no acute distress Skin: Intact HEENT: Grossly normal Neck: Supple Lungs: Within normal limits/clear CV: RRR Abdomen: Soft, BS active Extr: WNL Neuro: Unchanged and nonfocal ASSESSMENT/PLAN: Reviewed and signed orders. Recheck in 60 days. Patient was seen today for cough. Diagnoses and all orders for this visit: COVID-19 Cough CXR 2 view. Plan to start melatonin, vit D3, zinc. Rehab nurse note: Table of Contents for Miscellaneous Notes Telephone Encounter - RN - 02/09/2021 9:30 AM CST Telephone Encounter - 02/09/2021 9:16 AM CST Telephone Encounter - RN - 02/09/2021 9:30 AM CST Discussed with Dr. and he recommended that patient go to ER for urgent evaluation/treatment with dyspnea and low O2 levels even with supplemental oxygen. Electronically signed by RN at 02/09/2021 9:32 AM CST Back to top of Miscellaneous Notes Telephone Encounter - 02/09/2021 9:16 AM CST Rehab called, they stated PT was having trouble breathing and her O2 was 80 with oxygen. They wanted to know if they should bring her in but PT is Covid positive. Staff recommended that she go to the ER. Electronically signed at 02/09/2021 9:17 AM CST 2/9 ER-> admission note: (6day admission) History The patient is a 65 y.o. female with a past medical history notable for History of anemia, anxiety, cirrhosis, COPD, CHF, diabetes, reflux, hypertension. The patient presents for evaluation of Worsening issues of cellulitis in addition to the patient's history of recent Covid 19 infection. Patient also tested positive for influenza. Patient was started on steroids at skilled care facility. Patient was already on breathing medications. Patient has had issues with CHF and lower extremity swelling. Patient was taking a diuretic for this. Due to patient's cerebral kidney function patient is not a candidate for certain medications or either influenza, Covid 19 and we are limited on antibiotics. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. 3/1/21 er to admission note: currently inpatient History The patient is a 65 y.o. female presents for evaluation of altered mental status. Notable PMHx: CHF, morbid obesity, diabetes, Patient is 3 weeks out from hospitalization for COVID-19 pneumonia. She has been more confused over the couple of days before admission. Because of altered mental status, patient was transferred to the emergency room. Patient also had some shortness of breath. In the ER, she had a chest x-ray which showed moderate interstitial infiltrate secondary to pulmonary edema or pneumonia. Lab work did show a UTI. BNP was normal at 45. Creatinine was near her baseline at 1.8. She did have elevated alkaline phosphatase at 452. White count was elevated at 14.7. Patient was difficult to arouse in the ER. On my exam, patient is difficult to arouse. After shaking her shoulder and yelling at her, she did open her eyes and say to me "I'm ok" before closing her eyes again. She is satting well on nasal canula oxygen.

High Blood Preaseure 183/79, headache, disorientation, temporary forgetfulness, vomit. All these happened around 9:00 p.m. As soon as those signs appeared we rushed her to the ER. The results showed Brain bleed. She was transfered to Hospital where she was valorated again and other series of test were performed. On Tuesday, 02/16/2021 she was discharged from the hospital with Discharge Diagnoses: //Bilateral subarachnoid hemorrhage //Intractable headache //Essential hypertension, uncontrolled//Generalized anxiety disorder. Thursday 03/04/2021 we follow up with the neurologist. Saturday 03/06/2021 she went to the ER with blood preasure of 189/83.

Suddenly went into afib, shortness of breath, throat was tight for a short time, body felt cold inside, shaking inside

Rhabdomyolysis; her CPK was over 2400; Muscle cramps/Muscle spasms; Petechia; Dry skin; Itching; Fatigue extreme/felt tired; Myalgia; Pain; This is a spontaneous report from a contactable Nurse. A 65-year-old female patient received first dose of BNT162B2 (BNT162B2; Lot number EL0140 for both doses, expiry date not reported) via an unspecified route of administration to right deltoid on 23Dec2020 at 15:00 single dose, and second dose via an unspecified route of administration to right deltoid on 13Jan2021 15:15 at single dose for covid-19 immunization, hepatitis a vaccine (HEPATITIS A) intramuscular on 29Dec2020 at single dose for immunization and varicella zoster vaccine rge (cho) (SHINGRIX) intramuscular from 29Dec2020 at single dose for immunization. Medical history included osteoporosis from 2011, osteoarthritis from an unknown date, Knee replacement (Reported due to the osteoarthritis, she had her one knee replaced in 2004 and her other knee replaced in 2011), Spinal compression fracture in 2011 (Reported she fell at work and had a spinal compression fracture in 2011. She said the spinal compression fracture was repaired by a vertebroplasty in 2011) and Hypothyroidism (she has had hypothyroidism for a long time, since either 1998 or 2000). The patient's concomitant medications were not reported. The patient experienced rhabdomyolysis on 06Feb2021, fatigue extreme/felt tired on 30Dec2020, myalgia on 30Dec2020, pain on 30Dec2020, petechia on 06Feb2021, muscle cramps/muscle spasms on 17Feb2021, dry skin on Feb2021, itching on Feb2021 and her cpk was over 2400 on an unspecified date. The patient was hospitalized for rhabdomyolysis from 06Feb2021 to 09Feb2021 and reported to have caused disability. All the other events were reported as medically significant. She said she wanted to report to Pfizer that she was admitted to the hospital on 06Feb2020. She said she was in rhabdomyolysis, and the rhabdomyolysis was really bad. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she was given a lot of fluids while she was in the hospital. She said her CPK was over 2400 when she was admitted to the hospital on 06Feb2021. She said she had so much fatigue, myalgia, and pain that she couldn't walk. She said she has a petechia rash, cramps, muscle spasms, dry skin and itching now. Reported she literally saved herself from dialysis by going to the hospital. She said she kept putting off her symptoms, and took Tylenol and Naproxen for the whole month of Jan2021. She said her symptoms started brewing up from day 1, clarifying that her symptoms were not really bad until 30Dec2020 and 31Dec2020. She clarified on 30Dec2020 she took Naproxen, Ibuprofen, and Tylenol for her symptoms, and nothing helped her. She said she knew her symptoms were not normal for her, and she went for the whole month of Jan2021 with her symptoms. She said finally there came a time when she said "oh no, this is not normal at all", and she told herself she needed to check in at the hospital. She said she took Naproxen and Tylenol, and felt a little better, and drove herself to the hospital. Reported she kept walking and taking medicines, and while at work she diverted her mind from her symptoms, but when she came home she felt tired, and would tell herself she couldn't do it anymore. She said she doesn't know if what she experienced was from the COVID-19 Vaccine, but that definitely she had a reaction to either the Hepatitis A booster, the Shingrix Vaccine, or the Pfizer COVID-19 Vaccine. Reported she received 11 bags of Normal Saline (1000ml per bag) while she was in the hospital. She said fluid resuscitation was the only way to bring her CPK levels down and to treat the rhabdomyolysis. Reported her symptoms have improved. She said her last CPK was 134 on Wednesday, 17Feb2021. Reported she had cramps and severe muscle spams in her right leg on 17Feb2021, and then had cramps and muscle spasms in her left leg the following day. She said the cramps and muscle spams have not gone away completely. Reported she has a small petechia rash on her lower legs. She said at the moment the petechia rash shows up on her leg, she knows she is going to have a muscle spasm in that area. She said last night she had 2 petechia rashes show up on the lateral side of her right ankle. She said the petechia rash started to burn, and her right leg calf muscle became heavy. She said she could tell her right leg calf muscle was going to start to spasm, so she took some coconut oil and applied the coconut oil to her right leg calf muscle and massaged her right calf muscle. She said she had 2 areas of petechia last night (23Feb2021). She said the first time the petechia was noticed was when she went to the Emergency Room on 06Feb2021. She said the petechia has been persisting since that time. She said prior to being admitted to the hospital she never had dry skin or itching, but now she has dry skin and itching. She said she was using coconut oil to keep her skin moist. She stated she had 2 telehealth calls (11Feb2021 & 18Feb2021) because of a petechia rash and muscle cramps and was asking her doctor is she may need to go back to the hospital. The patient underwent lab tests and procedures which included blood work, CBC and Thyroid level on 06Jan2021 with unknown results (she had regular blood work done for her yearly checkup on 06Jan2021 (BMP, CBC, and Thyroid level). Also included CPK on 06Feb2021 greater than 2400, CPK on 09Feb2021 566 and CPK on 17Feb2021 134 (units were unspecified), She said her last CPK was 134 on Wednesday, 17Feb2021. Therapeutic measures were taken as a result of rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain, muscle cramps/muscle spasms, her CPK was over 2400. Outcome of the event rhabdomyolysis, fatigue extreme/felt tired, myalgia, pain and her cpk was over 2400 was recovering. Outcome of petechia, muscle cramps/muscle spasms, dry skin and itching was not recovered.; Sender's Comments: Based on the information currently available, a causal relationship between reported events and BNT162B2 vaccine cannot be excluded. The Hepatitis A booster and the Shingrix Vaccine may have also played a contributory role. 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.

Adverse event: 36 hrs of Atrial Fibrillation. BP157/107 HR 158 Treatment: Rx blood thinner (Eliquis) and beta blocker (Metoprolol) No further adverse event to second Pfizer Covid Vaccine dose Lot #EN6202 on 03/21/2021 while on prescribed treatment. Ok now while on meds until appointment with cardiologist in May 2021 (FYI-My sister also had similar adverse reaction to Moderna 1st dose)

Full anaphylaxis, Vertigo, Blood Pressure spike to 200 and it lingered there. Sent immediately to Hospital. Was administered IV Benadryl and Prednisone. Slept for three hours. BP dropped to 165 and was released with Benadryl and Prednisone to take for the next four days. Next several days of nausea, diarrhea, fever, weakness, shakes. No energy. Not feeling well until March 14th.

Patient was noted to have abrupt respiratory failure 2 days after taking the 1st dose. The patient was admitted to the hospital for acute respiratory failure with hypoxemia secondary to acute CHF exacerbation. The patient had a transthoracic echocardiogram performed 2 weeks prior to hospitalization that was noted to show a left ventricular ejection fraction of 60-65%. At the hospitalization, her left ventricular ejection fraction was noted to decrease to 25-30%. Left heart catheterization was performed and showed no signs of ischemic heart disease (coronary artery disease). Patient was started on Entresto 24/26mg PO BID and Toprol XL 50mg PO daily and was diuresed with Bumex 1mg IV daily and was noted to have improvement in respiratory symptoms for which she was weaned off of BiPAP 15/5 with FiO2 of 50% down to room air. Patient had repeat transthoracic echocardiogram ordered prior to discharge and was noted to have an improvement in left ventricular ejection fraction to 48% prior to discharge. The only change was that the patient had the COVID-19 vaccination. Patient does not have any history of coronary artery disease or heart failure. Patient was worked up extensively for other etiologies of heart failure and none were found.

Just 38.5 hours after receiving my 2nd dose of the Pfizer Covid-19 Vaccine I suffered a Cerebral Vascular Accident, a CVA, a Stroke @ 5:05a.m. in our home. My entire right side was paralyzed & unable to speak. My husband alerted #911 & fortunately @ the hosp. I received immediate life saving care. I had a C.T. Scan which revealed #2 blood clots in the left side of my brain. Intravenous T.P.A. was administered & then a thrombectomy was performed. Hospitalized approx. 5:45a.m on Sun., Feb. 28th, 2021 till my discharge on Wed., March 3rd, 2021@ 5:30pm.

Seizures; throat swelled up; Troponin level increased; Mild heart attack; arm was hurting; breathing issues; Dry heaves; Mucus to come out; Nauseous; Dizzy; Headache; Ears became hypersensitive; Senses heightened; Throwed up; This is a spontaneous report from a contactable other health professional (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration in arm left, on 27Feb2021 (lot# EN6205), as 0.3 ml single, for COVID-19 immunisation. Medical history included seizure from 2017 (she hasn't had a seizure in 8 months), allergy (to a lot of things). Concomitant medications were not reported. The patient did not have other vaccinations in 4 weeks prior. Within 15 minutes from having the vaccination at the center the patient experienced the first seizure that lasted about an hour. The seizure was really bad, she had breathing issues, dry heaving like she was trying to throw up, mucus to come out. The paramedics checked her out, they stayed around until she came out of the seizure. The patient went home and then at 07:50 PM she started heavy shallow breathing, was nauseous, dizzy, had a headache, which also happened at the center. Ears became hypersensitive, it was so noisy like loud, but her husband and the paramedics said it wasn't loud but she could hear it, all of her senses were heightened. She had a second seizure and didn't known how long it lasted. Patient had another seizure at 08:25 PM, at 08:40 PM she had another one, at 09:00 PM patient was coming back around and had another seizure and her throat closed up and that's when she went to the hospital, when her throat started to close up. While the patient was in the emergency room (ER) she had another seizure, she had 6 total seizures, she has never had this many before so she knows it was an adverse event to this vaccination. The seizures also increased the patient's heart enzymes- troponin levels. The patient has an EEG, was given 4 baby chewable Aspirin, as she had a mild heart attack. She thought the seizure increased her troponin. The patient mentioned that during the first event at the center, she was so into the seizures, she remembers grabbing her left shoulder, her arm was hurting. She was so into the seizure and trying to throwing up that it didn't dawn on her. The hospital didn't tell her she had a mild heart attack, it just dawned on her because her troponin levels were up mildly and she thought the seizures were triggering something in her heart, not just her seizures. The patient got another headache and was dizzy and had shallowing breathing. Seizures recovered on 28Feb2021. The patient underwent lab tests and procedures which included chest x-ray: normal, it didn't show pneumonia or fluid on the lungs on 27Feb2021, electrocardiogram (EKG): normal on unspecified date, electroencephalogram (EEG): normal on 27Feb2021, troponin: increased on 27Feb2021. Follow-up attempts are completed. No further information is expected.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

7 weeks after 2nd vaccine (given 01/16/2021) patient I developed a DVT in LLE. I have no underlying health conditions, I have no risk factors and am in excellent health. Described as an "unprovoked DVT."

Death unknown. Patient caregiver reported that it may be related to broken heart syndrome due her family member's passing.

My throat felt like it was going numb. A nurse gave me an injection of my epi pen, then a shot of Benadryll. I was taken to the ER via ambulance and given two 24 hour steroids. I was in the ER for about 4.5 hours.

Gasping for air; Tongue swelling; Swollen lips; Throat closing/restriction in her throat; tickle in the throat; Headache; Dizzy; couldn't think clearly/her thinking wasn't clear; Confused; sensation in her chest; weak; fatigued; she had a full tongue which effecting her talking; tingling in her lips; anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot Number: EN6198; Expiration Date: Jun2021), as single dose in left shoulder on 04Mar2021 at noon for COVID-19 immunisation. Medical history included Hashimoto's disease from May2012 and ongoing (autoimmune condition), ongoing undifferentiated connective tissue disease (UCTD) (autoimmune condition, unsure when diagnosed, started with polymyalgia rheumatica, then it went to rheumatoid arthritis (RA), then it went between Lupus and undifferentiated connective tissue disease), hospitalization: she had to go hospital twice in last 4 months, one was for Amlodipine which has polyethylene glycol and another time for Lisinopril as another blood pressure medication, she had 2 mild anaphylactic reactions in the last 4 months from amlodipine and Lisinopril, patient thought they all have PEG in the ingredients; underwent colonoscopy unknown results. There were no concomitant medications. On 04Mar2021 the patient experienced anaphylactic reaction, gasping for air, headache, dizzy, could not think clearly/her thinking was not clear, tongue swelling, swollen lips, throat closing/restriction in her throat, confused , sensation in her chest, weak, fatigued, she had a full tongue which effecting her talking, tickle in the throat, tingling in her lips. Course of events was as follows: The patient drove two hours to get the vaccine. The patient was vaccinated on 04Mar2021 at noon. The reaction started immediately, the caller had a severe headache within seconds, a little bit of sensation in her chest. The patient's thoughts were getting mixed up, she was not thinking clearly. This was one of first things that happened. The patient stumbled a little bit and the nurses were there around her and said she better sit down now. Then the sensation in her throat was starting to feel like it was closing up, her lips were swollen; so she would say she was a little bit confused. The patient started getting dizzy and her thinking was not clear, her tongue swelled, she had a full tongue which effecting her talking, she was gasping for air, she needed a moment to regulate her breathing. In regards to swollen lips she added at first she had a tickle in the throat, tingling in her lips, restriction in her throat, then she started slurring her words before the ambulance got there. On site they responded and watched her because she did not know if the symptoms were going to get worse. The paramedics gave the caller oxygen and an IV, since she had a mild experience she wanted to see what she did not take any medications before taking the vaccine so she could see what it would do, she did not take an ibuprofen or Tylenol. Patient commented, she knew it was not recommended, but some people do it. The patient mentioned started speaking very badly and very fast, she started gulping for air, and was informed the histamines are hitting her. She felt like she was going to faint, she thought if she was able to count back from ten she was going to be knocked out. Once she counted back she started to feel better. Like she would not faint. She did not faint often. She mentioned counting backwards from ten when getting a colonoscopy or something like don't get passed five and then knocked out, so she knows the sensation that can occur. After 1.5 hours they decided to call the emergency number and that was when the ambulance came. The ambulance service was the one who did everything for the patient. Because the patient got in the ambulance, they required her to go to the hospital, she was in a bed in the hall, by the time her doctor had looked at her, her throat had opened up and was feeling reasonably well after an hour an half. Confirmed she was not admitted just in the Emergency Room. On 04Mar202 the patient was at the hospital and was gasping for breath. The patient was on an IV and they gave her 125 mg of Solu-Medrol, 50 mg of Benadryl, and 5 mg of nausea medicine, phedrol the caller thought it was called. They did a good job and that helped the patient down from the most severe symptoms and she wanted to report her symptoms. The patient has been looking around and she thought this reaction it was from the polyethylene glycol. She mentioned historically she had a minor reaction. She had to go hospital twice in last four months. One was for Amlodipine which has polyethylene glycol and another time for Lisinopril which is another blood pressure medication. She confirmed she visited the emergency room for all 3 of these cases. The patient was still very confused on 09Mar2021 and over the weekend, she had to rest, she was weak and fatigued. On 09Mar2021 it was first real day she went back to work. She worked and asked her brother to watch out for her. On 10Mar2021 she was starting to feel a little bit better as regarded anaphylactic reaction, she has recovered with residual effects from the anaphylactic reaction. Confusion was improved but stull a concern. The outcome of anaphylactic reaction was recovered with sequelae, of headache, swollen lips, confused was recovering, of gasping for air, dizzy, could not think clearly/her thinking was not clear, tongue swelling, throat closing/restriction in her throat, sensation in her chest, weak, fatigued, she had a full tongue which effecting her talking, tickle in the throat, tingling in her lips was unknown. Patient asked if there was a conclusion about the PEG and her anaphylactic reaction. Her second dose was scheduled on 25Mar2021. Patient stated that her PCP and the CDC recommend to not get the second dose. Caller wanted to know if the anaphylaxis could be worse in the second dose. The patient wanted to know if she should she get the next dose. She was very concerned about COVID as well but did not know if it's worth her risking her life. Patient wanted to know if she can get the Johnson and Johnson vaccine after a certain amount of time after receiving the Pfizer COVID 19 vaccine, caller cannot get the second dose of the Pfizer COVID vaccine due to a reaction. As of 12Mar2021 patent stated she does not wish to be contacted any further. A Product Complaint was filed.

bilateral pneumonia; severe headaches; bronchial cough; low grade fever; body aches; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6202; expiry date: not known), via an unspecified route of administration, administered in arm right on 24Feb2021 11:00 as a single dose for COVID-19 immunisation. Medical history included COVID-19 on 21Dec2020 with reported symptoms of bilateral pneumonia, severe headaches, bronchial cough, low grade fever, and body aches. The patient is not pregnant. Concomitant medications included budesonide, formoterol fumarate (SYMBICORT); and codeine phosphate, guaifenesin (CODEINE GUAIFENESIN). The patient previously took gabapentine and experienced allergies. No other vaccine received in four weeks. Clinical course was reported as follows: she tested positive for COVID-19 on 21Dec2020 and recovered. She had bilateral pneumonia, severe headaches with bronchial cough, low grade fever and body aches which lasted five weeks. She was fully recovered but had intermittent mild symptoms lingering. On 25Feb2021 08:00, within 24 hours of getting the first vaccine, she developed all these symptoms again, but they were severe again and had to start prescriptions meds again daily to manage them and she still experiencing them now. She was due to have her second vaccine on Wednesday, 17Mar2021 and she was considering postponing it after her primary care (PC) doctor suggested she did so till her symptoms subsided. These adverse events resulted in doctor/other healthcare professional office/clinic visit. The patient had COVID prior vaccination and had not tested post vaccination. The patient had not recovered from all the events. No follow-up attempts are possible. No further information is expected.

Blood clots; This is a spontaneous report from a contactable consumer (reported for herself). A 65-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6199, expiry date not reported), via an unspecified route of administration, administered in left arm on 03Mar2021 10:45 at a single dose for covid-19 immunisation. Medical history included known allergies to sulpha. The patient had no Covid prior vaccination. Concomitant medications included atorvastatin (LIPITOR) and lisinopril, both taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient had the vaccination on a public health clinic/veterans administration facility. On 12Mar2021, patient experienced blood clots that resulted in doctor other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient was not tested for Covid post vaccination. Therapeutic measures were taken as result of the event which included that the patient was put on blood thinners. The event blood clots recovered with lasting effects.

she is a heart attack survivor; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 10Mar2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had her first vaccine ended up being a Pfizer vaccine. She received her Pfizer vaccine on 10Mar2021 and the next is scheduled 07Apr2021. She was wondering if she should schedule somewhere else to get another vaccine sooner. The patient was a heart attack survivor on an unspecified date. Outcome of the event was unknown. Information on the lot/batch number has been requested.

This is a spontaneous report received from a contactable female consumer reported for herself that a 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6203, Expiration date: unknown) via an intramuscular route on left arm on 08Mar2021 at 13:10 (at the age of 65-year-old) as a single dose for COVID-19 Immunization. The patient medical history included ongoing Autonomic neuropathy (Affected her digestive tract. Lost teeth, part of esophagus, gall bladder, stomach and large part of small intestine), Clostridium difficile, several anaphylactic reactions (immediate anaphylactic reaction with bee sting), malnutrition, walker, hypoglycemic, dermatitis from gloves, Hives for several medication (Reglan, compazine, levaquin, cipro, doxycylcine, zpac, arithromycin, sulfa drugs-macrodantin, chorhexadine, tropomate tramadol, msl4, codeines, hydrocodone, oxycodone, ultracept, Carries 4 epi pens in different locations), allergy: corticosteroids, on J tube 12 years, PICC line for 3 years, stomach had to be taken out (A tiny pouch was made where they connected what was left of her esophagus to small intestine. The pouch is the size of a quarter). The patient concomitant medication included teduglutide (GATTEX, Lot number: 1908G, expiration date: Apr2023) ongoing at a dose of 5ml, daily; dicyclomine (capsule, expiration date: 16Mar2022) ongoing at 10mg (2 capsules 3 minutes before meals and bedtime) from an unknown date in 2002; sucralfate (expiration date: Oct2021) ongoing at 100kg/m3, 4 times a day for help keep food down, colesevelam hydrochloride (expiration date: May2022) ongoing at 625mg, twice a day for help aide digestion, fludrocortisone (tablet, expiration date: 23Jan2022), ondansetron (ZOFRAN, Lot number: ON0820008-A, Expiration date : Jan2024) ongoing at 8mg as needed for nausea; midodrine (Expiration date: 22Oct2021) ongoing from 2018 at a dose of 5mg, thrice a day for orthostatic hypotension; alprazolam (tablet) at a dose of 1 mg; ongoing gabapentin. On 8Mar2021, with 5 minutes after vaccination had an anaphylactic reaction- Was taken by ambulance-Caller couldn't breathe or swallow- tongue was thick, couldn't breathe, Tachycardia, chest hurt and felt bruised afterwards, Nausea, Constipated, Oxygen level was down to 90, legs and arms were flapping, could not swallow, felt like she had brain fog. Nurse watched her carefully and she was sent to sit for 30 minutes. The doctor gave her a shot of Epinephrine and it backfired, so she didn't get it. The other doctor got it and the ambulance was there working on her. Oxygen level was down to 90 and was given Decadron. Her legs and arms were flapping due to her disease, because epinephrine was a vasodilator. It was reported that in ambulance patient Was being asked questions and she couldn't talk on 08Mar2021. The patient was taken to the hospital and was given more benadryl, and more epinephrine. Then she felt better over the next few days. She saw her own physician the next day and was given Solumedrol in her tush, 40 mg prednisone twice a day, for 3 days. The patient felt her cognitive skills were not working well the first few days and could not walk very well, even with her walker on an unknown date in Mar2021and dropped 5 dishes in one day. Caller provided information regarding article from British government stating people with history of anaphylaxis should not take Pfizer vaccine. Article stated FDA is still working with Pfizer on this. The patient states she should never have been given that shot and requests for compensation. The patient reported that she was never been so afraid in life. The patient had hematoma after 3 sticks for IV in ambulance on 08Mar2021 and had warm hot packs on it. The patient Oxygen level was low and was given 2liters nasal cannula, which was bumped up to 4 liters. The patient felt like a robot, did not have good control of legs or arms and flailing like baby when epinephrine was given. The patient took Fludrocortisone for Adrenal insufficiency, With all the steroids, should have felt fabulous but didn't. The patient Clarified Epinephrine junior was given in the thigh and backfired. Was given Epinephrine in her other thigh, Was given Benadryl at Vaccine facility. In emergency room patient received Famotidine IV 20mg/50ml STAT 1 dose, Sodium Chloride 0.9% 1000 ml over one hour STAT for hydration, Another sodium chloride 0.9% 1,000ml, Another sodium chloride 0.9% 1,000ml and discharged from emergency room after 6 hours. The patient stated she could not have second COvid-19 Vaccine that was scheduled for this coming Monday. The patient had undergone laboratory test on08Mar2021 potassium was 2.9, EKG was abnormal (tachycardia) and standard blood work was unknown. The outcome of the events anaphylactic reaction was recovering, tongue was swollen was recovered on an unknown date in Mar2021 while for other events was unknown. Follow-up Information has been requested.; Sender's Comments: Based on known drug safety profile and close temporal association the event of Anaphylactic reaction is assessed as related to the suspect vaccine BNT162B2. As there is limited information in the case provided for gait disturbance, adrenal insufficiency and injection site haematoma, the causal association between the events and the suspect vaccine 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 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.

Patient has COVID-19 + diagnosis 2/16, recovered, received first dose Pfizer on 3/5/21. Admitted to outside hospital on 3/17 with acute on chronic respiratory failure due to HCAP and acute Congestive Heart Failure exacerbation. Discharged 3/22.

anaphylactic; reactions are allergic; Terrible airway swelling, it felt like breathing through a straw, narrowing airway; Sensation of throat closure/narrowing of airway; significant shortness of breath/difficult to breath like through a straw; Pain in both lymph nodes, under both the armpit; Pain in both breasts; Dry cough; Itching, airway/trachea itchy; Hoarseness; Dizziness; This is a spontaneous report from a contactable nurse (patient). A 65-years-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248), via an unspecified route of administration, administered in the left deltoid on 15Feb2021 at 15:30 as a single dose for protection against Covid. Medical history included ongoing obesity as she gains and loses it, ongoing hypertension, ongoing asthma (at 59 she was bumped up to moderate degree asthma), ongoing significant food allergies, was born with and had ongoing eczema so she was allergic to milk (was given soy milk since she could not tolerate milk, when she drank milk, it produced phlegm/caused increase in mucus, ongoing significant environmental allergies wherein she would have allergies in the fall, from August through September and would have sneezing, congestion and itchy watery eyes. The patient also had a history of getting bronchitis but has not had it for a long time. The patient got stung by a bee when she was 40ish and her upper thigh got red, itchy and it lasted for 10 days and she and no other symptoms and was now careful around bees. The patient reacts to the smoky matches that blow out and make smoke, from the sulfa in the matches, fireplaces, wood burning and firepits. Concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma, start and stop date were not reported and fluticasone (manufacturer unknown) taken for asthma and allergies, start and stop date were not reported. The patient was on significant medications for her asthma, allergies and blood pressure. The patient previously got a flu shot at the end of Oct2020. The patient also previously took Aleve in her early 40's and was taking them for a neck injury for 2-3 months and at the end of the treatment she broke out in a rash. The patient also previously took aspirin 3 years ago and broke out in a rash. The patient also has an albuterol inhaler but has not taken it for years. The patient was careful, handwashing normally, wipes the shopping carts as they are germy. The patient stated that after receiving the vaccine, one main event was terrible airway swelling, itching and it was difficult to breathe. The terrible airway swelling felt like breathing through a straw and narrowing airway. She stated that it started 18.5 hours after the vaccine, on 16Feb2021 at 10 am and lasted for 4 hours between 10 to 2 pm. The patient also had itching wherein her airway and trachea were itchy which also started on 16Feb2021 at 10 am to 2 pm. The patient experienced narrowing of airway and sensation of throat closure also between 10 am to 2 pm. The patient also experienced that it was difficult to breathe but she did not feel like she needed to go to the hospital. If it got any worse she would gave went to the emergency department. She stated that she was sitting up, walking around and she would have had a significant shortness of breath and she was trying to wait it out. It was difficult to breath like through a straw which also started from 10 am to 2pm. She did not feel like she wanted to walk or do daily activities. She was on the phone with her mother and her mother could hear her difficulty in talking and her heavy breathing. The patient also experienced pain in both lymph nodes, under both armpits and pain in both breasts which started also on 16Feb2021 at 10 am and lasted for 24 hours the 10 am the next day. The patient had dizziness which started about noon and when she woke up the next day it as gone which she considered as medically significant since she is never dizzy and it was not due to her blood pressure and she has been on pills for a long time. The patient had dry cough and hoarseness also on 16Feb2021 from 10 am to 2 pm. The patient was afraid to take the second vaccine and she spoke to her pulmonologist who knows her history and was told that she would benefit. She thought that if she felt bad, she would go to the emergency room if it got worse but it did not. The patient stated that she thinks these reactions are allergic, the itching and narrowing of throat can be anaphylactic. The patient did not require any medical intervention and was not seen in the emergency department and was not hospitalized. The events lasted for 4 hours and stayed at that level. The patient did not get any treatment and it went away. The outcome of the events terrible airway swelling, it felt like breathing through a straw, narrowing airway, Dry cough, Itching, airway/trachea itchy, Hoarseness, Sensation of throat closure/narrowing of airway, reactions are allergic and anaphylactic was recovered on 16Feb2021 at 14:00. The outcome of dizziness was recovered on 17Feb2021 and the outcome of pain in both lymph nodes, under both the armpit and pain in both breasts on 17Feb2021 at 10:00. The patient reported that the events were considered as medically significant. The relatedness of the drug to the reactions from primary source reporter (method of assessment: Global Introspection) for the events was related.; Sender's Comments: A contributory role of vaccine BNT162B2 to reported events cannot be fully excluded since it is part of the product safety profile. Potential contributors include patient's advanced age, as well as underlying obesity, hypertension, asthma, eczema, multiple allergies and other co-morbidities. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Pt with Advanced PD underwent surgery on 3/1/21 and 3/8/21 to explant a malplaced DBS device and re-implant with a new DBS device. She struggled to recover following the surgeries and did not respond to her medications or the new device. She received her COVID vaccine on 3/15/21. No significant change following the vaccine but no improvement as expected as device settings and medications were titrated. We received a call from her husband that she died during the night of 4/1/21. She had seen her PCP on 3/31/21 without any concerns on vitals etc.

Pt presented to ED w/SOB, fever, cough, sore throat, headache, chest congestion, generalized weakness, & fatigue that had started 4/4/21 and diagnosed w/COVID-19 (4/10/21). She had just received 2nd vaccine (3/27/21), but had been exposed to COVID-19 the following day from a relative. She was discharged w/dexamethasone and pulse oximeter. Symptoms had continued to worsen and returned to ED where she was admitted for acute hypoxemic respiratory failure and tachycardia secondary to COVID pneumonia requiring steroids, remdesivir, oxygen, but unfortunately succumbed to her illness (4/18/21) given condition critical and prognosis poor.

submassive PE and DVT with right heart strain, required ICU admission and anticoagulation. Brother developed PE 2 weeks after pfizer vaccine as well.

Fever. Chills, hallucinations, renal failure, ischemic colitis, gi bleed, blood clot,, dehydration

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented with abdominal pain and nausea and admitted for anticoagulation (heparin) and monitoring for SMV thrombus. Patient developed fever to 40 degrees Celsius and underwent diagnostic laparoscopy with evidence of recovering ischemia of the jejunum and omental adhesion along the left abdomen. Found to have left upper extremity superficial thrombophlebitis concerning for early suppurative complications in setting of persistent fevers and mild thrombocytopenia. Heparin discontinued when thrombocytopenia developed and platelet counts have increased.

Patient with dementia NOS received COVID-19 vaccination first dose (as reported) on 3/30/2021. Family reported she was feeling unwell with vague complaints thereafter. Found dead on 4/27/2021. Autopsy performed on 4/28/2021 revealed ischemic bowel with an acute superior mesenteric artery thrombosis. She had little other cardiovascular disease to account for the thrombosis.

April 22, 2021 morning my auntie got her first dose of Pfizer vaccine. She happily shared here vaccine experience with family member and relative. April 23 morning, she told us she has severe abdominal pain, has the need to have a bowel movement, but she was defecated. She also told us that she vomit couple times already, then she has no more energy to talk. She got into the hospital and she was announced death right after midnight at 12:04 April 25th. Reason of death given is "septic shock secondary to ischemic bowel & intra-abdominal sepsis". But it is the blood clots issue that is causing it. I was told that after my auntie got into hospital the very next day after Pfizer vaccine, hospital later found out that my auntie has blood blockage issue that is causing blood couldn't flow to her intestines. The acid in her blood was very high, 6+. After more than 6 hours without blood to her intestines, her intestines tissues start dying and turned black color. Doctor found out about this at the night of April 23, 2021 nighttime. April 22, 2021 morning is the day my auntie got her Pfizer covid vaccine. There is a very high chances of the Pfizer vaccine is causing the blood clots that lead to blood blockages.

stroke; face sunk in and changed/Bells Palsy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 65-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6202), via an unspecified route of administration, administered in the left arm on 16Mar2021 at 14:00 as a single dose for COVID-19 immunization. Medical history included a mild case of COVID-19, last year, on an unspecified date in 2020. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks of the COVID vaccine. On 21Mar2021, the patient's face sunk in and changed. The patient's symptoms were not improving. Her eye and right side of her face are affected. She cannot close her right eye. She worked on it and is now able to close right eye not like the left eye closes, but it doesn't blink as the left eye does. She has been using eye drops for this. She said it was Bells Palsy. The patient added that it is hard to look in the mirror. She will not get the second dose. She was not interested in taking the vaccine now. She wanted to wait and see. It being so new and see. Her sister took it and encouraged her, and said it is necessary because they like to travel. She got Prednisone when she was at the hospital, they gave her 60mg Prednisone. Her physician didn't want to keep her on it too long and said it may cause other complications. Her physician cut her off, she weaned her down 50mg, 40mg, 30mg, 20mg, then 10mg. When the patient noticed her face start to turn, she went to the ER. She thought she was having a stroke. The patient was not admitted to the hospital. The outcome of the event face sunk in and changed/bells palsy was not recovered while the outcome of the event stroke was unknown.

kidneys were inflamed; grade IIIa kidney failure; got a flight or fight response; lower lip was full tingling; tongue tip so irritated and a strange feeling that it was a tiny bit edematous; tongue tip so irritated and a strange feeling that it was a tiny bit edematous; mucoid eruption on her lower lip/ mucoid eruptions in her mouth, on her palate and down her throat; rash to her face, neck, chest, back, shoulders and thighs; has bright red palms and sole of her feet are bright red; it looked like Kawasaki disease; voice change; had joint pain in her left arm and could not use her left arm and her whole entire arm and hand; had left clavicle pain under the clavicle; spontaneous cough where her heart races; spontaneous cough where her heart races; felt she couldn't catch her breath; issues in her throat and neck area had something pressing around her throat; she was so tired; chest flutters; tingling in her hands and her entire body from her scalp to her soles was so irritated and prickly; may be body inflammatory response to being vaccinated; This is a spontaneous report from a contactable Nurse (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07Mar2021 09:40 (Lot Number: EN6199) (at the age of 65 years old) as single dose (dose 1) for COVID-19 immunisation; and methylprednisolone (MEDROL), via an unspecified route of administration from an unspecified date to an unspecified date at short term increase of the Medrol dose (as reported), from unspecified date to an unspecified date at 2 mg (for four years, as reported), then from unspecified date to 10Mar2021 at 6 mg, then from 11Mar2021 to 13Mar2021 at 8 mg, then from 14Mar2021 to unspecified date at 6 mg, for Lupus. Medical history included diagnosed with asthma initially exercised induced and now it is seasonal and was diagnosed years ago (states she has not had to use her Albuterol inhaler that much now because it is seasonal but she is doing more outside and is allergic to outside things so she tends to use the inhaler more if needed), right leg paresthesia (she did have a right leg paresthesia and had that before the vaccine), autoimmune disorder, thyroid disorder and patient stated that she has lost height. Concomitant medications included salbutamol (ALBUTEROL HFA) taken for asthma; levothyroxine sodium (SYNTHROID) taken for thyroid disorder; paracetamol (TYLENOL); and diphenhydramine hydrochloride (BENADRYL). The patient had a history of Lupus and is on maintenance Medrol 2mg for four years and before that she had a short-term increase of the Medrol dose with flares of her Lupus. She had the Pfizer COVID Vaccine 1st dose and then three days later on 10Mar2021 at 16:00, she thought what is going on and had her tongue tip so irritated and a strange feeling that it was a tiny bit edematous, her lower lip was full tingling. She had mucoid eruption on her lower lip and saw then that the next day thought it was swollen but it wasn't swollen. She had eruption on her tongue, had a rash to her face, neck, chest, back, shoulders and thighs. The rash was dispersed and there is a red raised rash with Lupus called Livedo reticularis and that is usually on the thighs but this rash on her was below her thighs and came up and dispersed between all the same rash elsewhere on her body. The healthcare professionals were closed so she took increased Medrol steroids and her Albuterol inhaler and Benadryl; the Benadryl was thrown out and discarded so she has no lot number to provide for it, stated that the Benadryl was the pediatric dye free bubblegum free. The Albuterol Sulfate HFA inhaler is 90mcg per puff and she does two puffs every 6 hours as needed; she had not taken the inhaler but she has trouble with asthma and took the Albuterol inhaler now as preventative and needs to use the inhaler as of yesterday (lot Y23B with expiry date Dec2021). Patient stated that she has the tools of her Albuterol inhaler, the steroid Medrol and the Benadryl and the knowledge so she prevented the symptoms she was reporting from being life threatening but stated the reported events were a little disabling and medically significant.She had joint pain in her left arm and could not use her left arm and her whole entire arm and hand. She had left clavicle pain under the clavicle and knows this did occur in the random trials but for her it went away after two days and is now back regarding the pain. She has bright red palms and sole of her feet are bright red. The next morning on 11Mar2021, her upper lip was tingling and she did go see her healthcare professional in town and sent photos to her Rheumatologist. As time went on she had tingling in her hands and her entire body from her scalp to her soles was so irritated and prickly and her soles and palms were bright red; it looked like Kawasaki disease and she used to take care of children with Kawasaki disease. On Saturday which was the 3rd day she was on the Medrol 8mg and had the fight or flight cardiac symptom and she cut herself down on the Medrol on the next Sunday to 6mg which seemed to make her better. The redness was gone until she had the Pfizer COVID Vaccine 2nd dose yesterday and the healthcare professional initially said after her 1st dose of the vaccine to wait and see her rheumatologist do decided to do the increased Medrol dose of steroids and she stated she has got to get the 2nd dose of the Pfizer COVID Vaccine; the healthcare professional checked her lungs that were clear and her pulse ox was fine and she was not wheezing and she then went on increased steroids from Medrol 6mg to 8mg right away. She did have a right leg paresthesia and had that before the vaccine so she knows what it is like because she has issues with her spine but had not had the paresthesia in a long time. She increased to Medrol 8mg for the three days after the 1st dose of the Pfizer COVID Vaccine and got a flight or fight response. She had to increase the Medrol dose from 6mg and popped it up to 8mg and she had mucoid eruptions in her mouth, on her palate and down her throat and had a voice change. She has a laryngoscopy on Thursday (25Mar2021) with her ENT. She has pediatric doses of everything because she reacts to almost everything. The 2nd dose of the Pfizer COVID Vaccine was administered to her on 29Mar2021 09:45 with lot ER8732. Patient stated that anyone else would have gone to the emergency room but she took care of herself at home and knows the risk factors related to the vaccine. She absolutely felt the reported events were related to the Pfizer COVID Vaccine in terms of causality and she never had these issues before. The rheumatologist had experience with patients with autoimmune diseases and stated people with autoimmune disease have a heightened immune reaction to the vaccine no matter which vaccine they get and are overly active and then a vaccine is thrown in there and we are charting new territory. The next Thursday or Friday over a week now after the Pfizer COVID Vaccine she had a multisystem type of thing and on 18th and 19th of March she started having episodes and was not doing anything but quietly doing something and had chest flutters and spontaneous cough where her heart races and felt she couldn't catch her breath and is now on a 30 day event monitor. She was not sure this is due to the Medrol steroids or the Pfizer COVID Vaccine. She got her thyroid TSH level done because sometimes when the Synthroid dose needs to be lowered because it is too high for your body and you can have atrial flutter which she has had before in the past from her Synthroid dose being too high; states her Synthroid is 50mcg and takes it once per day by mouth and it is in a prescription bottle with no lot, expiry date or NDC. Patient saw her primary care physician again last Tuesday on 23Mar2021 and all the issues in her throat and neck area had something pressing around her throat and thought it was lymph nodes and woke up with a voice change and physician said he would take a look and he said it was not thrush and she would have to be scoped because he couldn't see in her throat. She had a referral for a CBC and Chemistry lab to be done on 25Mar2021 and TSH was in the usual range for her, the results from Thursday (25Mar2021) night had her BUN and creatinine and GSR (Glomerular filtration rate) abnormal. The rheumatologist called her that night and talked to the physician and said he considered this may be body inflammatory response to being vaccinated and could be that her kidneys were inflamed and she does not know as this is all new territory. For the kidney issues, the information was sent off to the rheumatologist who did orders and called the physician back the next day and she told him she thought she needed a nephrology consult and had urine chemistry, a urinalysis and looked for protein and did a blood draw for a chemistry screen with the following results on 25Mar2021: BUN 22.3, grade IIIa kidney failure, creatinine 1.28, eGSR-NAA 42ml/min, normal is over 60 and she usually runs 70 something. She went to the hospital over the years to have her chemistry lab done because she has Lupus and over the last two years she has never been below 60 for the eGSR-NAA. On 26Mar2021, she repeated the blood work and sent everything to her physician and the CMP had her BUN still elevated at 19.5, the creatinine was down to 0.97 and the eGSR-NAA was up to 58mL/min which is still abnormal; the urinalysis was all fine with no white cells and no leukocytes and no protein; the urine chemistry had the creatine of 8.5, the protein in the urine LVL was less than 0.4mg. Her CBC had her lymphs and monos down and she would expect having this response to the vaccine. Both physician called her on the weekend and they were concerned this came out of nowhere and now are monitoring her again in a month; her physician and rheumatologist both were entertaining this could be related to the Pfizer COVID Vaccine. She does not take vaccines because of what they do to the body and did take the flu vaccine in Oct2020. She was covid negative (unspecified date) and stated had to be screened on Friday 26Mar2021 before her laryngoscopy and did the PCR test and only does the PCR. States she was doing research and had conflicting information from her physician and rheumatologist who she first saw her physician, after her 1st dose of the vaccine and the rheumatologist talked about increasing her steroids and she told him she was so tired and how with increased steroids, do steroids impact the effectiveness of the covid vaccine being blunt immune suppressants. Physician said long term chronic steroids have no effect on the effectiveness of the vaccine. She has no had headaches, shaky chills like everybody else has because she is on immune suppressants and has an article that says some evidence for steroids diminishing efficacy in Pfizer COVID Vaccine. No prior vaccinations within 4 weeks. No additional Vaccines administered on same date of the Pfizer suspect. Events required a visit to physician office (No visit to the ER but did see her physician). The last action taken in response to the events for methylprednisolone was unknown. The outcome of the event had left clavicle pain under the clavicle was recovered on 12Mar2021; event has bright red palms and sole of her feet are bright red was recovered in Mar2021; outcome for the other events was unknown.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but possible contributory effects from patient's medical history and concomitant medications cannot be completely ruled out. 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.

Do not know that this is a reaction to the Vaccination but, approximately 2 weeks after the second dose of the Pfizer vaccine, I was admitted to the hospital with Bilateral and saddle pulmonary embolism with acute cor pulmonale, repeated syncope, elevated troponin and BNP and RV strain by CT as well as EKG. 1. Ultrasound-guided right common femoral venous access. 2. Pulmonary angiogram. 3. Pulmonary artery pressure measurement. 4. Bilateral selective pulmonary angiogram. 5. Flowtreiver thrombectomy of bilateral pulmonary arteries with extraction of large thrombus burden.

Atrial Fibrillation for 4 1/2 hours; 1st dose was 31Mar2021, 2nd dose on 04Apr2021; 1st dose was 31Mar2021, 2nd dose on 04Apr2021; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 04Apr2021 13:00 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation. The first dose was received on 31Mar2021 13:00 on the left arm. The patient medical history was not reported. Patient was not pregnant. Concomitant medications included flecainide, apixaban (ELIQUIS), atorvastatin and unspecified multivitamins. No other vaccines within four weeks. The patient experienced atrial fibrillation for 4 1/2 hours on 22Apr2021 07:30. Flecainide was given as treatment. Outcome of the event of atrial fibrillation was recovered on an unspecified date. Patient did not have covid prior to vaccination and had not been tested post-vaccination.

This 65 year old female received the Pfizer Covid shot on 3/10/21 and went to the ED on 5/3/21 and was admitted on 5/3/21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident) (CMS/HCC) FACIAL DROOP

My left leg and ankle became very, very swollen and sore. I experienced severe pain in my left thigh, left knee and left calf whenever I sat, walked, went up and down stairs, while sleeping and I was limited in what activities I was able to do without pain. I went to the doctor on 3/29/2021 (9 days after my first shot) and the doctor sent me for an ultrasound of the left leg and an X-ray of the left ankle..

Developed heart arrythmia which worsened over the month and was hospitalized end of march with PVC, PACs and non sustained run of ventricular tachycardia.

Well basically I just went into Afibb and I experienced it for next 3 days. I called my Doctor and then went into his office and he put me on a heart monitor and then it resolved itself after the 3 days.

ED to Hosp-Admission Discharged 5/9/2021 - 5/11/2021 (2 days) Principal problem Discharge Summary Discharge Summary Hospitalist Medicine Date: 5/11/2021 Admission Date: 5/9/2021 Length of Stay: 2 Days Discharge Date: 5/11/2021 Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) Sepsis Yes Type 2 diabetes mellitus, with long-term current use of insulin Not Applicable Benign essential hypertension Yes CKD (chronic kidney disease), stage IV Yes Gastroparesis Yes Granulomatosis with polyangiitis Yes Hypothyroidism Yes COVID-19 virus infection Yes DVT, lower extremity, proximal, acute, right Yes Acute on chronic respiratory failure with hypoxia Yes Monilial vulvitis No Hospital Course: Patient recently was admitted for possible sepsis picture. He was treated according to sepsis protocol including antibiotics for bacterial infection for pulmonary infiltrates however it was felt the pulmonary infiltrates are more related with COVID-19 pulmonary findings. Eliquis was started for DVT. Medical Center had been contacted Dr was the pulmonary attending and discussion is documented below- Attending hospitalist spoke to Dr from Medical Center. At this point they know that she has Wegener's granulomatosis involving her kidneys and causing her renal failure but they do not think that is what is going on in her lungs. They have still trying to work-up her infiltrates. She has it we obtain a nocturnal oximetry study. She was reassured that the patient is on her normal oxygen rate despite the DVT in her leg. She feels this should rule out a pulmonary embolism. If the patient is doing well from cardiopulmonary standpoint tomorrow she should be able to go home on Eliquis and follow-up with the specialist. She was continued on Monistat cream for 3 nights total. At this point patient will not require antibiotics will continue on Decadron and may be discharged to follow-up with her specialist.

Sore throat, Fever, unspecified fever cause, Exposure to COVID-19 virus ED to Hosp-Admission Discharged 4/1/2021 - 5/14/2021 (43 days) Hospital MD Last attending o Treatment team COVID-19 Principal problem Discharge Summary MD (Physician) o o Internal Medicine HOSPITAL DISCHARGE SUMMARY HOSPITALIST GROUP . Patient: Date: 5/14/2021 DOB: Admission Date: 4/1/2021 MRN: Length of stay: 43 Days PCP:MD Discharging provider: MD Admission diagnosis: Primary Admission Diagnosis Medical Problems Hospital Problems Hospital Course HPI: Past medical history significant for type 1 diabetes mellitus, essential hypertension, obstructive sleep apnea, peripheral vascular disease status post femoropopliteal bypass 2016, status post multiple toe amputations on left foot, history of right foot osteomyelitis, left foot osteomyelitis in November 2020 who presented to ER on 4/1/2021 with shortness of breath. She was diagnosed with acute hypoxic respiratory insufficiency in the setting of Covid pneumonia with AKI, hyponatremia, troponin elevation, LFT elevation admitted to regular floor on high flow nasal cannula oxygen. Patient was intubated on 4/2/2021 for increased work of breathing and worsening hypoxemia and hypercapnia. Later patient was found to have persistent Candida fungemia. Hospital Course: Persistant Candida fungemia, now improving Blood cultures positive for Candida albicans from 4/12, 4/14 and 4/17/2021. Cardiology was consulted for TEE, done on 04/30 which was negative for vegetations. Ophthalmology was consulted and there was no evidence of fungal endophthalmitis. Blood cultures from 4/23/2021 so far no growth. PICC line has been placed. ID recommendations appreciated. -Currently patient on 6 weeks of IV micafungin, to be continued through 6/7/2021 as per ID recommendations. ID has therapy plan in system Moderate to severe pharyngeal dysphagia Post extubation SLP and modified barium swallow demonstrated aspiration with thin and thickened liquids. S/p PEG tube on 5/7/2021. CT head did not reveal any infarct. Repeat modified barium swallow done today , patient now advanced to level 3 soft diet with thin liquids. -Continue with tube feeds and alter tube feeds based on patient's diet advancement Type I Diabetes mellitus: Labile blood sugars in the setting of changes done to tube feeding. Patient currently on tube feeding and diet has been advanced today. Regimen at the time of discharge Lantus twice daily: With sliding scale insulin and standing dose of short-acting insulin with tube feeds bolus. -Patient will need close monitoring of her blood sugars given changes being done to tube feed and diet advancement, will need titration of insulin based on blood sugars. Lower extremity edema, improved Likely dependent lower extremity edema. Echo April 2021 reviewed: Normal EF, no diastolic dysfunction. -Elevate legs while patient is seated -Ace wraps -Restarted home dose of hydrochlorothiazide Acute on chronic anemia Received 1 unit of blood transfusion during this hospitalization Monitor hemoglobin Vitamin B12 and folate level normal. Hb on last check was 8.0 COVID-19 pneumonia Acute hypoxic and hypercapnic respiratory failure -resolved Status post extubation 04/06/2021 Treated with Remdesivir,convalescent plasma, Decadron as well as Tocilizumab. Treated with IV vancomycin, Levaquin and cefepime in the setting of possible secondary bacterial pneumonia. CT chest ruled out PE but showed extensive infiltrates on admission. Patient is off Covid precautions Currently saturating well on room air and stable from respiratory standpoint. Elevated d dimer, POA : Patient had elevated D-dimer on presentation. Lower extremity ultrasound 4/3/2021 was negative for DVT. CT chest ruled out PE. She was initially placed on intermediate dose of anticoagulation. D-dimer eventually trended down. Currently patient is on subcu heparin for prophylaxis. AKI POA now resolved Creatinine stable. -Continue to monitor renal function, electrolytes and urine output. Hypernatremia : resolved Acute Urinary retention, now resolved. Foley catheter was placed on 4/24 after patient had multiple straight cath done. DC'd Foley catheter on 5/3/2021. Patient is currently voiding without any issues. Chronic medical issues : o Essential Hypertension: On amlodipine, Coreg and hydrochlorothiazide. o Peripheral vascular disease status post femoropopliteal bypass: Restarted home aspirin, statin. _ Admission Current 5/14/2021 - present (6 days) Hospital MD Last attending o Treatment team COVID-19 with multiple comorbidities Principal problem Physical Medicine and Rehabilitation History and Physical Date: 5/14/2021 Admission Date: (Not on file) PCP: MD DOB: Hospitalist: MD Assessments Patient is a 65 y.o. female on hospital day number 0 Active Problems: No Active Hospital Problems: There are no active hospital problems currently on the Problem List. Please update the Hospital Problem List and refresh. IMPRESSION / PLAN: 1. Covid pneumonia/sepsis with hypoxic respiratory failure Received remdesivir, dexamethasone, convalescent plasma Received IL-6 inhibitor Intubation 4/1/2021–extubated, O2 weaned and now tolerating room air CTA chest 4/22/2021–extensive consolidation in both lungs C/W Covid pneumonia, no PE 2. Diabetes mellitus type 1 Lantus scheduled dose twice daily Humalog every 6 hours scheduled and sliding scale Insulin to be adjusted as PEG feedings decrease 3. Diabetic peripheral neuropathy arterial insufficiency Status post femoropopliteal bypass 2016– Status post right common femoral and mid popliteal bypass 9/28/2020 Dr. –no use of synthetic graft Status post remote history of multiple toe amputations left foot osteomyelitis Acute necrotic areas of feet being treated locally 4. Candida albicans fungemia On 6-week course of IV micafungin Weekly CBC, LFT, sed rate, CRP and BMP 5. Essential hypertension On amlodipine, carvedilol, HCTZ, 6. Dysphagia PEG tube placed 5/7/2021–Dr. Cleared for dysphagia level 3 soft diet thin liquids 5/14/2021 Aspiration precautions Speech and Language Pathology 7. Decreased ambulation and functional mobility and functional ability for activities of daily living Physical therapy, Occupational Therapy Plan Patient is admitted for comprehensive inpatient rehabilitation program consisting of physical therapy, Occupational Therapy, speech and language pathology, rehabilitative nursing, psychology, and case management support. Goals will be aligned with patient family goals and directed to improving functional mobility, functional interaction, and activities of daily living to allow the patient to return home safely and continue his rehabilitation as an outpatient or at a home health basis. Estimated length of stay is 16 days. Patient has a good prognosis History of Present Illness Patient is an 65 y.o. female with history of diabetes mellitus type 1 hypertension and sleep apnea who became febrile with shortness of breath over several days. Her PCP, Dr, ordered Covid test which was positive. She presented to Hospital on 4/1/2021 for further work-up. On admission she was found to be in hypoxic respiratory failure requiring high flow oxygen which progressed to requiring a nonrebreather and eventually intubation with ICU care. She received remdesivir, dexamethasone, and convalescent plasma. Patient also received IL-6 inhibitor Tocilizumab recommendation of pulmonary critical care. Procalcitonin level was 35.32. Because of concern of superimposed bacterial pneumonia she was also treated with broad-spectrum antibiotics. Patient had a prolonged complicated acute care hospital course. On 4/12/2021 ENT evaluation showed poor phonatory effort but mobile true vocal cord without lesions. Patient was found to have a fungemia from cultures of 4/12/2021 of C albicans with positive blood cultures with C. albicans on 4/17/2021. Patient was placed on IV micafungin for a total of 6-week course. TEE showed no evidence of acute valve pathology. Ophthalmology was consulted and there was no evidence of fungal endophthalmitis. Repeat blood cultures from 4/23/2021 showed no growth. Patient had PEG tube placed by Dr of GI on 5/7/2021. Repeat modified barium swallow on 5/14/2021 showed improvement of swallowing and the patient was upgraded to a dysphagia level 3 soft diet with double swallows and thin liquids via cup or straw with aspiration precautions. Patient was evaluated by therapies while at Hospital acute care. She requires supervision to rise from sit to stand using a rolling walker and contact-guard ambulate 45 feet using a rolling walker with wheelchair follow and verbal cues for walker management. She continues to have some knee buckling. She needs minimal assistance for bathing and min mod assistance for lower body dressing. She is able to perform toileting with contact-guard. Acute inpatient rehabilitation was recommended. Patient is being transferred to the Hospital for comprehensive inpatient rehabilitation program. Additional information for Item 19: Updated Procedure 04/01/21 1217 Respiratory virus detection panel Collected: 04/01/21 0917 | Final result | Specimen: Swab from Nasopharynx Adenovirus Not Detected Mycoplasma pneumoniae Not Detected Chlamydophila pneumoniae Not Detected Parainfluenza Not Detected COVID-19 SARS-CoV-2 Overall Result DetectedCritical Enterovirus/Rhinovirus Not Detected Coronavirus Not Detected Respiratory Synctial Virus Not Detected Influenza A Not Detected Bordetella pertussis Not Detected Influenza B Not Detected Bordetella parapertussis Not Detected Metapneumovirus Not Detected 03/27/21 1807 COVID-19 (SARS CoV-2,RNA Molecular Amplification) Collected: 03/27/21 0859 | Final result | Specimen: Swab COVID-19 SARS-CoV-2 Overall Result DetectedCritical Labs/Imaging LABORATORY: CBC: Results from last 7 days Lab Units 05/13/21 0557 05/10/21 0614 05/09/21 0724 WBC AUTO K/mcL 5.4 5.0 4.7 HEMOGLOBIN g/dL 8.0* 8.0* 8.5* HEMATOCRIT % 24.7* 25.3* 26.4* PLATELETS K/mcL 201 197 196 NEUTROS PCT AUTO % 67 -- -- LYMPHS PCT AUTO % 21 -- -- MONOS PCT AUTO % 8 -- -- EOS PCT AUTO % 4 -- -- CHEMISTRY: Results from last 7 days Lab Units 05/14/21 0609 05/13/21 0557 05/10/21 0614 SODIUM mmol/L 137 134* 136 POTASSIUM mmol/L 4.2 4.2 3.9 CHLORIDE mmol/L 103 101 104 CO2 mmol/L 28 25 26 BUN mg/dL 23 21 16 CREATININE mg/dL 0.86 0.78 0.82 CALCIUM mg/dL 9.0 8.8 8.6 Results from last 7 days Lab Units 05/14/21 0609 05/13/21 0557 05/10/21 0614 MAGNESIUM mg/dL 2.0 1.9 1.7 COAGULATION: OTHER TESTS: 0 Lab Value Date/Time TROPONINI 0.10 (H) 04/06/2021 0412 TROPONINI 0.17 (H) 04/03/2021 0436 TROPONINI 0.29 (H) 04/02/2021 1655 TROPONINI 0.28 (H) 04/02/2021 1323 TROPONINI 0.29 (H) 04/02/2021 1107 TROPONINI 0.28 (H) 04/02/2021 0546 TROPONINI 0.38 (H) 04/01/2021 1248 TROPONINI 0.15 (H) 04/01/2021 0857 TROPONINI 0.01 11/27/2012 0522 TROPONINI 0.08 (H) 11/26/2012 1104 TROPONINI 0.04 11/26/2012 0626 TROPONINI 0.04 11/25/2012 2304 IMAGING: Gastrostomy tube, place Result Date: 5/7/2021 Gastrostomy tube, place Procedure Note Surgical Pre-Operative Patient Identification Yes, after the patient was placed on the operating room/procedure table, I confirmed the patient's identity. Impression Overall Impression: Normal EGD up to second part of duodenum. 20 French PEG placed without any immediate complications. Recommendation There is no recommended follow-up for this procedure. Okay to use back for medications and water flushes. Start feeding via PEG tomorrow after GI evaluation. Indication Pre-procedure diagnosis: Pharyngeal dysphagia Post-procedure diagnosis: See impression Preprocedure A history and physical has been performed, and patient medication allergies have been reviewed. The patient's tolerance of previous anesthesia has been reviewed. The risks and benefits of the procedure and the sedation options and risks were discussed with the patient. All questions were answered and informed consent obtained. Details of the Procedure The patient underwent monitored anesthesia care, which was administered by an anesthesia professional. The patient's blood pressure, heart rate, level of consciousness, oxygen, respirations, ETCO2 and ECG were monitored throughout the procedure. The scope was introduced through the mouth and advanced to the second part of the duodenum. Retroflexion was performed in the cardia, fundus and incisura. The patient experienced no blood loss. The procedure was not difficult. The patient tolerated the procedure well. There were no apparent complications. See anesthesia record for more information regarding anesthesia administered. Specimens * No specimens in log * Implants No implants documented in log. I attest the accuracy of any implant/graft nursing documentation. Findings The cricopharynx, upper third of the esophagus, middle third of the esophagus, lower third of the esophagus, GE junction, Z-line, cardia, fundus of the stomach, body of the stomach, greater curve of the stomach, lesser curve of the stomach, incisura, antrum, prepyloric region, pylorus, duodenal bulb, 1st part of the duodenum and 2nd part of the duodenum appeared normal. PEG-G tube successfully placed in the body of the stomach using a deformable internal bolster via the pull technique after the site was identified via transillumination, visualized indentation and needle passed through abdominal wall; distance from external bolster to external end of tube: 3 cm; scope reinserted to confirm placement Staff/Assistant(s) Staff Role RN Other CRNA Other Other MD Other Disposition: PACU - hemodynamically stable. Condition: stable Attending Attestation: I performed the entire procedure. CT abdomen pelvis without contrast Result Date: 4/15/2021 PROCEDURE INFORMATION: Exam: CT Abdomen And Pelvis Without Contrast Exam date and time: 4/15/2021 12:00 AM Age: 65 years old Clinical indication: Other: Na; Additional info: Distention, fungemia workup. TECHNIQUE: Imaging protocol: Computed tomography of the abdomen and pelvis without contrast. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. COMPARISON: No relevant prior studies available. FINDINGS: Tubes, catheters and devices: Small bowel feeding tube noted. Lungs: Bibasilar patchy nodular airspace disease with ground-glass opacity. Liver: Normal. No mass. Gallbladder and bile ducts: Multiple gallstones. Pancreas: Normal. No ductal dilation. Spleen: Normal. No splenomegaly. Adrenal glands: Normal. No mass. Kidneys and ureters: Bilateral renal vascular calcifications. Stomach and bowel: Visualized bowels demonstrated a generalized constipation. Appendix: Not well seen. Intraperitoneal space: Unremarkable. No free air. No significant fluid collection. Vasculature: Moderate atherosclerotic changes. Lymph nodes: Unremarkable. No enlarged lymph nodes. Urinary bladder: Unremarkable as visualized. Reproductive: Unremarkable as visualized. Bones/joints: Degenerative changes within the lumbar spine. Soft tissues: Unremarkable. IMPRESSION: Bibasilar nodular airspace disease with ground-glass opacity. No other acute inflammatory process or obstructive uropathy within the abdomen and pelvis. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD X-ray abdomen 1 view Result Date: 5/4/2021 XR ABDOMEN 1 VW PORT IMPRESSION: Weighted enteric tube with the tip in the gastric antrum. Residual oral contrast throughout a nondilated colon. END OF IMPRESSION: INDICATION: ng tube placement ng tube placement. TECHNIQUE: AP supine portable projection of the abdomen was acquired. COMPARISON: AP abdomen on 4/15/2021. FINDINGS: The gas pattern is unremarkable. There is residual oral contrast equally distributed throughout a nondilated colon. There is a new weighted enteric tube with the tip in the gastric antrum. Small right lung base pleural effusion is present. No abnormal mass effect is noted. No significant radiopaque calculus is identified. There are no significant bony findings. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray abdomen 1 view Result Date: 4/15/2021 XR ABDOMEN 1 VW PORT IMPRESSION: Orogastric tube is in the stomach. Nonspecific bowel gas pattern. END OF IMPRESSION: INDICATION: Feeding tube placement. TECHNIQUE: Single view of the abdomen. COMPARISON: Prior examination of April 15, 2020. FINDINGS: Orogastric tube is in the stomach. Nonspecific bowel gas pattern is noted. Osseous skeleton is grossly intact. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. CT head without contrast Result Date: 4/21/2021 CT HEAD WO CONTRAST IMPRESSION: No acute intracranial pathology. Mucoperiosteal thickening in the ethmoid sinuses as well as some opacification of the bilateral mastoid air cells consistent with chronic sinus disease and mastoiditis. END OF IMPRESSION: INDICATION: DYSPHAGIA DYSPHAGIA. TECHNIQUE: Spiral CT scan through the head from the skull base through the vertex was performed with 5 mm axial reconstructions. Images obtained without contrast. CONTRAST: No contrast was administered. COMPARISON: April 13, 2021 FINDINGS: No acute hemorrhage, mass, or mass effect. No abnormal extra-axial fluid collections are identified. There is preservation the gray-white differentiation. No evidence to suggest large vascular distribution infarct. The ventricles, cisterns, and other CSF containing spaces demonstrate normal size, shape, and configuration. The basal cisterns are patent and symmetric. Stable focal area of gliosis in the right frontal white matter. The calvarium is intact. The visualized portions the aerated paranasal sinuses mastoid air cells demonstrate bilateral ethmoid sinus mucoperiosteal thickening. Additionally there is scattered opacification of some mastoid air cells bilaterally. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Fluoroscopy video swallow with speech therapy Result Date: 4/19/2021 FL VIDEO SWALLOW WITH SPEECH THERAPY MBSS IMPRESSION: Aspiration of thin and nectar thick liquid. Please refer to speech therapy report. END OF IMPRESSION: INDICATION: Dysphagia. Concern for aspiration. Covid 19. SUPERVISION: Procedure was performed by RRA under direct supervision by MD TECHNIQUE: Fluoroscopy assistance was provided to the speech pathology department. Multiple consistencies of barium and food products were administered to the patient. Fluoroscopy of the oral and pharyngeal region was performed. FLUOROSCOPY TIME: 1.1 minutes COMPARISON: Modified barium swallow of 4/12/2021. FINDINGS: Aspiration of thin and nectar thick fluid. Hypopharyngeal residue with all trials provided. Significant dry secretions in the oral cavity and pharynx. Please see speech pathologist's report for further details and recommendations. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Fluoro NG long tube placement Result Date: 4/30/2021 FL NG LONG TUBE PLACEMENT IMPRESSION: Successful fluoroscopically guided Dobbhoff placement. END OF IMPRESSION: INDICATION: Dobbhoff placement. SUPERVISION: Procedure was performed by staff member under personal supervision by Dr.. TECHNIQUE: Fluoroscopic guidance for nasogastric tube placement. FLUOROSCOPY TIME: 2.2 minutes COMPARISON: None available. FINDINGS: Using fluoroscopic guidance, a nasogastric tube was placed from the left nares into the stomach. Upon placement of the nasogastric tube, 10 cc of Omnipaque contrast material was injected to confirm placement. Opacification within the stomach was visualized confirming appropriate NG tube placement. There were no intraprocedural complications and the procedure was well tolerated by the patient. The patient was discharged from the imaging department in satisfactory condition. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray chest 1 view Result Date: 4/26/2021 XR CHEST 1 VW PORT IMPRESSION: NG tube in the fundus of stomach left upper abdomen. END OF IMPRESSION: INDICATION: SOB evaluate NGT placement following advancement.. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: 4/26/2021 FINDINGS: NG tube in the fundus of stomach left upper abdomen. Stable diffuse patchy infiltrates both lungs in the upper, mid to lower zones and left effusion. No pneumothorax. The heart size is normal. Rib cage is unremarkable. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray chest 1 view - portable Result Date: 4/26/2021 XR CHEST 1 VW PORT IMPRESSION: 1. Interval increase in diffuse airspace opacity and effusions from prior. 2. NG tube tip in the region of the GE junction. Consider further advancement. END OF IMPRESSION: INDICATION: Hypoxia, acute shortness of breath. TECHNIQUE: Portable AP view of the chest is acquired. COMPARISON: 4/22/2021. FINDINGS: Diffuse airspace opacity and effusions appear mildly increased from prior. The NG tube tip is in the region of GE junction. Recommend further advancement. No pneumothorax is identified. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray chest 1 view Result Date: 4/22/2021 XR CHEST 1 VW PORT IMPRESSION: Persistent diffuse patchy infiltrates bilaterally, consistent with Covid infection. END OF IMPRESSION: INDICATION: hypoxia. Covid 19. TECHNIQUE: AP upright projection of the chest is acquired. COMPARISON: Radiographs of 4/18/2021. FINDINGS: The cardiomediastinal silhouette is unchanged. Persistent diffuse patchy infiltrates bilaterally, consistent with Covid infection. No evidence of pleural effusion or pneumothorax. No significant change compared to prior radiographs. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray chest 1 view, Portable Result Date: 4/18/2021 XR CHEST 1 VW PORT IMPRESSION: Enteric tube extends into the stomach. Tip collimated from view. Multifocal airspace disease, increased slightly since 4/13/2021. END OF IMPRESSION: INDICATION: Verify placement of NG tube. TECHNIQUE: AP upright portable projection of the chest is acquired. COMPARISON: 4/13/2021 FINDINGS: An enteric tube extends into the stomach; the tip is collimated from view. The lungs are symmetrically aerated. Multifocal airspace opacities are slightly increased since 4/13/2021. No pneumothorax or pleural effusion. Cardiomediastinal silhouette is stable. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Transthoracic echo (TTE) limited Result Date: 4/21/2021 FINALIZED REPORT TWO-DIMENSIONAL ECHOCARDIOGRAPHIC FINDINGS LEFT VENTRICLE: Normal size and function RIGHT VENTRICLE: Normal size and function AORTIC VALVE: Trileaflet sclerotic MITRAL VALVE: Mitral annular calcification TRICUSPID VALVE: Normal PULMONIC VALVE: Not well seen LEFT ATRIUM: Normal size RIGHT ATRIUM: Normal size INTERATRIAL SEPTUM: Intact AORTIC ROOT: Normal size PERICARDIUM: No effusion IVC: Normal size and normal collapse AORTIC ARCH: Not well seen COLOR AND SPECTRAL DOPPLER: PA systolic pressure in the range of 30 mmHg FINAL IMPRESSIONS: This is a technically limited study with poor acoustic windows and poor endocardial border definition. Normal LV size with normal wall thickness. No clear-cut regional wall motion abnormalities. EF 55 to 60% Normal RV size and function Aortic sclerosis Mitral annular calcification No vegetations or a source of fungemia noted Transesophageal echo (TEE) Result Date: 4/30/2021 FINALIZED REPORT TWO-DIMENSIONAL ECHOCARDIOGRAPHIC FINDINGS: INTUBATION: Anesthesia airway management provided by the anesthesiologist. I intubated esophagus myself without difficulty LEFT VENTRICLE: LV cavity size mild LVH normal function EF 55-60 RIGHT VENTRICLE: Normal RV size function AORTIC VALVE: Leaflet no vegetation MITRAL VALVE: Appears normal no vegetation TRICUSPID VALVE: Appears normal no vegetation PULMONIC VALVE: Appears normal no vegetation LEFT ATRIUM: Appears normal RIGHT ATRIUM: Appears normal INTERATRIAL SEPTUM: Intact SVC: Appears normal IVC: Appears normal PERICARDIU no effusion LEFT ATRIAL APPENDAGE: Appears normal PULMONARY VEINS: Not well seen AORTIC ROOT: Appears normal ASCENDING THORACIC AORTA: Appears normal AORTIC ARCH: Appears normal DESCENDING AORTA: Appears normal COLOR AND SPECTRAL DOPPLER: No stenotic regurgitant lesions noted FINAL IMPRESSIONS: No vegetations noted Normal LV cavity size wall thickness function EF 55-60 Normal RV size function No valve abnormalities Ultrasound upper extremity venous right Result Date: 4/24/2021 US UPPER EXTREMITY VENOUS RIGHT IMPRESSION: No DVT identified. Superficial thrombosis identified in the cephalic vein. END OF IMPRESSION: INDICATION: Concern for DVT. TECHNIQUE: Real-time two-dimensional ultrasound of the right upper extremity was performed with grayscale, color and duplex Doppler imaging. Compression and augmentation were performed where possible. Permanently recorded images were obtained and stored. FINDINGS: The internal jugular vein, subclavian vein, axillary vein, brachial veins, basilic vein are normal. They demonstrate normal flow and compressibility. There is a thrombus identified in the right cephalic vein at the mid arm through distal forearm. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. CT angiogram chest pulmonary embolism with and without contrast Result Date: 4/22/2021 CTA CHEST PULMONARY EMBOLISM W WO CONTRAST IMPRESSION: No evidence of pulmonary embolus or right heart strain. Extensive parenchymal consolidation in both lungs, left greater than right consistent with severe pneumonia such as Covid 19 pneumonia. Moderate left-sided small to moderate right sided pleural effusions are seen with associated compressive atelectasis. Enlarged main pulmonary artery which can be seen in the setting of chronic pulmonary hypertension. Interval development of large mediastinal adenopathy particularly in the right paratracheal region and subcarinal region. These may be reactive in nature in the setting of as diffuse pneumonia. Enterogastric tube with the tip extending to just within the stomach. END OF IMPRESSION: INDICATION: pneumonia. Assess for pulmonary artery embolism. TECHNIQUE: Enhanced helical CT scan of the chest was performed from the lung apices to below the diaphragm. 2mm axial reconstruction with MPR coronal, oblique and sagittal images were created. 3D shaded surface images also created on a separate workstation and permanently stored. CONTRAST: 100mL of IOHEXOL 350 MG IODINE/ML INTRAVENOUS SOLUTION administered INTRAVENOUS. Quality of contrast opacification was adequate. COMPARISON: July 22, 2013 FINDINGS: Lung windows demonstrate extensive consolidation involving the lungs, left greater than right. There is a moderate left-sided effusion and a small to moderate right sided effusion with associated compressive atelectasis. The trachea and bronchi are grossly unremarkable. No endobronchial lesions are seen. Soft tissue windows demonstrate a grossly unremarkable thoracic inlet. The thyroid is unremarkable. Moderate bilateral axillary lymph nodes are seen with extensive bulky adenopathy in the mediastinum to include the right paratracheal region as well as the subcarinal region and to a lesser extent the hila. The largest lymph nodes are seen in the paratracheal chain demonstrating short axis of approximately 15 mm. Smaller lymph nodes are seen in the aortopulmonary window. These may be reactive in nature. The heart demonstrates a normal configuration. No right heart enlargement is seen. No pericardial effusion is seen. The thoracic aorta and great vessels demonstrate normal branching pattern. Normal course and caliber is seen. The pulmonary arteries demonstrate normal course. There is moderate dilation of the main pulmonary artery up to 3.2 cm. This can be seen in the setting of chronic pulmonary arterial hypertension. No filling defects are seen. Enterogastric tube is seen with the distal tip extending to just within the proximal stomach. The visualized portions of the upper abdomen are grossly unremarkable. The surrounding osseous structures demonstrate mild degenerative changes of the thoracic spine. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient.

Throat was swollen, started having anaphylaxis; Throat was swollen, started having anaphylaxis; Blood pressure got totally out of control, it just spiked; had like a fever; Injection site turned red, swollen, angry, itching; Injection site turned red, swollen, angry, itching; Injection site turned red, swollen, angry, itching; got a very bad headache; nausea; chills; Brain fog; fatigue; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EW0162 and expiration date not provided), via an unspecified route of administration, in left arm, on 26Apr2021 09:30 (at the age of 65-year-old), at single dose, for COVID-19 immunization. Medical history included blood pressure, patient had anaphylaxis to other drugs in the past, the medication was an ace inhibitor caller took years ago when trying to help blood pressure. Family Medical History provided as "no". Concomitant medications included losartan for blood pressure (patient had been on this medication for years); and progesterone (began taking this medication probably last summer). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153 and expiration date not provided), via an unspecified route of administration, in left arm, on 05Apr2021 13:30 (at the age of 65-year-old), at single dose, for COVID-19 immunization. No additional vaccines administered on same date. The patient got a very bad headache from 26Apr2021 (about an hour after received second vaccine); nausea from 26Apr2021; chills from 26Apr2021; brain fog from 26Apr2021; fatigue from 26Apr2021; throat was swollen, started having anaphylaxis from 28Apr2021 (in the evening) to 02May2021 (it had eased up enough and patient could swallow); blood pressure got totally out of control, it just spiked from 28Apr2021, patient was still having trouble getting it back down. Patient had to double up on blood pressure medication. Patient stated it was persisting a little bit. Patient's blood pressure was going way higher than what it would normally. Patient only took 25mg of losartan. Patient's blood pressure usually never went over 125. Injection site turned red, swollen, "angry", itching and had like a fever from 28Apr2021. On 26Apr2021, patient got a very bad headache, nausea, chills and fatigue. Patient was expecting all of this. Patient was sick on 26Apr2021 and 27Apr2021 and had to stay in bed, clarified she was sick with headache, chills and fatigue. On 28Apr2021 (Wednesday), patient's throat was swollen, started having anaphylaxis. The outcome of the events "headache, nausea, chills, brain fog" was recovered on 27Apr2021; of "fatigue" was recovering; of "throat was swollen, started having anaphylaxis" was recovered on 02May2021; of "blood pressure got totally out of control, it just spiked" was not recovered; of "injection site turned red, swollen, angry, itching and had like a fever" was recovered on 03May2021.

Shortness of breath; pain; Didn't feel well at all; fatigue; I was in A-fib; sick; This is a spontaneous report from a contactable Nurse (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9269, Expiration date: Unknown), via an unspecified route of administration on 09Jan2021 (at the age of 65-years-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included Hodgkin's disease, Alopecia, Alopecia areata, Asthma, Back pain, Heartburn, Pulmonary embolism. The patient previously took Diltiazem and experienced allergic reaction. Concomitant medications included biotin (BIOTIN) taken for alopecia, finasteride (FINASTERIDE) taken for alopecia areata, hair fall; colecalciferol (VITAMIN D3) taken as a supplement, calcium (CALCIUM) taken for an unspecified indication, (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma, clobetasol propionate (CLOBETASOL PROPIONATE) topical solution that I put in my scalp for my alopecia, tramadol hydrochloride (ULTRAM [TRAMADOL HYDROCHLORIDE]) as Occasionally taken for back pain, lorazepam (LORAZEPAM) taken for PRN, for sleeping at night, rivaroxaban (XARELTO) Strength:20 mg taken for pulmonary embolism, esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]) as PRN taken for Heart burn, levothyroxine (LEVOTHYROXINE) I take that because my thyroid was killed after radiation from having Hodgkin's disease cancer, Docusate sodium with Senna (DOCUSATE SODIUM & SENNA) taken for an unspecified indication. It was also reported that the patient took, unspecified steroid injection in scalp for Alopecia. It was reported that, "I received the COVID-19 Vaccine on 09Jan2021 and the second one on 29Jan2021 Lot number EN6198 and about two weeks, let me go back to my calendar about four day after the first one I had my oral surgery on an unspecified date in Jan2021 and the next, they gave me a narcotic, Norco for pain. I took four of them and it was making me sick, so I stop taking it. The next day I didn't feel well at all. I actually felt like I was through Pulmonary embolism and I have a history of that (Consumer was unsure hence, Pulmonary embolism was not captured as event). So, I called doctor's office, it was closed so we messaged him and Monday he called and said you are on blood thinners you are not going through PE, I think you have been through a lot with the COVID-19 Vaccine then you had oral surgery and here you took Norco and he just said, just let your body rest, so I try to feel better in the next few weeks. The next time I saw a doctor I mentioned this to her that was on 10Feb2021 and it was a dermatologist that I see for alopecia areata (History) and I told her I am having shortness of breath on an unspecified date and lot of fatigue and she said that could be related to the COVID-19 Vaccine, you need to report that and I thought okay, you know she said you need time to get to your doctor. I said, I did, And he told me that it wasn't PE I just need to give my body time to recover from everything. She said (withheld) something is going on, shortness of breath and the fatigue that you are having doesn't sound right. She looked, the next day she called me at home and she looked up some stuff on COVID-19 and she said I really think you should report this and you really need to call the doctor now. So, I called the pulmonologist so again he didn't want to see me, he said you are not going through PE and you need to see cardiologist. So next week I had an appointment with the cardiologist on 19Feb2021. They said I was in A-fib on an unspecified date and they put me on cardiac medications you know to try and to get me medically to convert back into sinus rhythm and that was in February. In March I had an allergic reaction to Diltiazem they switched me to Metoprolol and then two and half months later I was still in A-fib, they sent me to electrophysiologist and Monday I had a cardio version done and so since then I see the dermatologist again for my alopecia and she said, did you ever contacted Covid or you know Pfizer you know you got that paper, when you got the vaccine they give you piece of paper that had phone number on it, I really think you need to let them know everything that happened and its all been since COVID-19 Vaccine. So I am just reporting what I have been through and by the way I am in sinus rhythm now but I am still having symptoms shortness of breath and fatigue. I messaged my doctor yesterday and I am waiting for a response from the electrophysiologist to find out you know why, when I am out of A-fib why I am still having the same symptoms. I take Metoprolol (treatment) because I was in A-fib they are trying to medically convert me and right now my dose has been tapered because I am back in sinus rhythm. So in a month I will be off of it. "Consumer further stated, "No, I just wanted you guys to be aware because my one doctor really insisted that I should call you. I mean I don't know if the Covid-19 vaccine has anything to do with all this or not I am just letting you know as a courtesy. The patient underwent lab tests and procedures which included EKG: unknown result on an unspecified date in Dec2020, EKG: unknown result on an unspecified date in Mar2021 (echo my ejection fraction was 55% and labs were done like in December because then I will have my annual physical done). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2 ,a temporal association between the event atrial fibrillation and administration of BNT162B2 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.

she slowly declined with pneumonia; Woozy/Dizzy; Sleeping all the time; Not eating; Running a fever off and on; Her blood pressure was a bit low, 105 over something; suspected COVID-19 with symptoms; Heart attack; This is a spontaneous report from Pfizer from a contactable Consumer reported for mother. A 65-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The cancer doctor told her that she needed a Covid vaccine since she has cancer and a lowered immune system. Medical history included Metastatic rectal cancer from Jul2019 to 17May2021, Osteoporosis from unknown date to 17May2021 (She had it for maybe 10 years or something), Fibromyalgia from unknown date to 17May2021 (She had the fibromyalgia for 20 years). She had rectal cancer, osteoporosis, fibromyalgia, and a couple other things that the caller can't think of off hand. Her mother was diagnosed with the rectal cancer in Jul2019. The caller has no idea when she was diagnosed with the osteoporosis. She had the fibromyalgia for 20 years, and the caller is sure it was the same for the osteoporosis, maybe 10 years or something. They were being managed. There were no concomitant medications. The patient did have metastatic rectal cancer, but it was managed. She was not on hospice or terminal, and they hadn't exhausted all of the treatment plans yet. It was being controlled. She was under the surveillance of a cancer doctor who was completely shocked by her sudden death. It seemed like there was no reason. She was fine and drove herself to her appointments all the time. She had just driven herself to her last appointment. She passed away yesterday morning. She was slowly declining since she got the vaccine. The coroner was playing guessing games and assumed it was pancreatic cancer. Well, she didn't have pancreatic cancer, and the doctor already said the cancer didn't kill her. The doctor said if he had to guess it could have been some kind of pneumonia or a reaction to the vaccine. All of it made her heart stop. The coroner couldn't get the city to approve an autopsy to see the real cause of death because there was no foul play. The caller took it upon herself to discover if maybe Pfizer could help, and she needs to alleviate the vaccine as an option if it contributed. She is so tired and hasn't slept. It is devastating. This woman was everything in her life, and the caller is probably going to go next with how she feels. She feels responsible. Her other guess is if she gave her mother Covid and she slowly declined with pneumonia. The caller couldn't get her sister to take her mother to the ER. Her sister was there Sunday night. On Monday morning her sister called to say her mother was gone. On 05May2021 the patient had the first dose of the Covid vaccine. The caller could have gone there or called an ambulance when her mother wasn't answering the phone. She knew something was wrong. She called her sister who said their mother wasn't feeling good. Her mother was woozy, dizzy, and sleeping all the time. On day 3, Sunday, the caller couldn't get her mother on the phone. She thought she had some level of peace because her sister was there and could keep her updated. Her mother often gets sickly, but she always answers the phone even if she is deathly sick. The caller thought enough is enough and she needed to be put on the phone on speaker with her mother. The caller's sister said her mother was sleeping. The doctor said to probably bring her mother to the ER. The caller told her sister who just didn't take her mother to the ER. The caller could have called an ambulance. She feels incompetent. They are assuming the cause of death was a heart attack. If her mother had gone to the ER on Sunday night they may have found out. Her mother became woozy last weekend because the caller was there on Thursday and her mother didn't look good. She had her chemo bag because she brings it home. It was her first new chemo treatment, and the caller had never seen her mother respond like this. It was strange. Any other time when she was getting chemo she felt great because there is so much stuff in there like steroids to prevent a reaction. It was surprising because she was only sick on chemo once and she had been on this one before. She was just off. Then she continued to decline from there. It started before the chemo. She got on chemo that Thursday before Mother's Day, she was on her first chemo treatment at that time. She was sick a couple of days before that. She had the chemo on 06May2021. She started feeling sickly the day she got the injection on 05May2021. When the caller was there she was thinking it was from the chemo. The caller calls her mother every day and she was sounding worse and worse. On Thursday 13May2021 her mother took herself to her chemo follow up appointment and was telling the doctor that she was woozy, dizzy, and not eating. The doctor gave her fluids, and he didn't give her chemo because she was not scheduled for it that day. It was just a follow up appointment. He sent her home. The caller talked to her mother on Thursday evening and she didn't sound good and told her she was woozy and dizzy. On Friday, Saturday, and Sunday she didn't answer the phone. The caller's mother is totally against vaccines, and she had been begged to get the pneumonia and flu vaccine and denied them. She had never responded well to them in her life. Even as a cancer patient they would say she needed it and she wouldn't. She did get the Covid vaccine even though she didn't want to. The caller thought her mother was trying to convince herself it was because of the vaccine because she is so against them, but now she doesn't know. The doctor said he didn't think it would have been Covid because she didn't have a fever. Her mother told her that she had been running a fever off and on, which is not unusual for her mother. The doctor didn't think it would have been Covid. Her mother started sleeping all the time mid week last week. She started not eating at the end of last week. The caller has no idea when her mother had a fever. She hadn't gotten to talk to her mother all weekend. At some point last week her mother had said in a conversation that she had a fever off and on. Then on Thursday when she went to the chemo doctor she had no fever it shows it was 97 something. Her oxygen was fine. Her blood pressure was a bit low, 105 over something, which is low for her. She didn't have a fever last Thursday. Prior Vaccinations within 4 weeks no other vaccinations. Blood work on 13May2021 with unknown result. The patient passed away on 17May2021 after receiving the first dose of the Pfizer Covid vaccine. The caller expresses concern that her mother may have had Covid. No autopsy done. Cause of death was Heart attack. Information on Lot/Batch number has been requested.; Reported Cause(s) of Death: Heart attack

Couldn?t breath, Ambulance to ER, Blood Test and Chest CT showed multiple pulmonary embolisms in both lungs, hospital stay for 3 days, multiple IV doses of Heparin, Echocardiogram showed enlarged right side of heart, released with script for Eliquis

She started having delusions and hallucinations, body tremors like epileptic seizure, she was falling down and using the bathroom on herself, her walk was a shuffled gate, she didn't remember almost 3 months in hospital, coma for 5 days and had a mini stroke. Her psych doctor thought maybe the vaccine could have triggered this type of reaction. She gained consciousness and was sent to a rehab nursing home where she's learning to walk to feed herself and getting stronger now that she's home. There's a long road to recovery.

Hypoxic respiratory failure; pneumonia; Stomach cramps; Could not breathe well; She had back problems; COVID-19; COVID-19; This is a spontaneous report from a contactable consumer (patient's husband). A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (Lot Number: EN6206) at the age of 65 years, as single dose for covid-19 immunisation. Medical history included back disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Previously the patient received the first dose of bnt162b2 on 14Feb2021 at the age of 65 years, lot number: ENG201, injection in arm, possibly in left arm: patient had no problems with the first shot. The patient experienced covid-19 (death, medically significant) on 07Mar2021, hypoxic respiratory failure (death, hospitalization) on 08Mar2021, pneumonia (death, hospitalization) on 08Mar2021, stomach cramps (non-serious) on an unspecified date with outcome of unknown, could not breathe well (non-serious) on an unspecified date with outcome of unknown, she had back problems (non-serious) on an unspecified date with outcome of unknown. Patient went to Emergency Room (ER) 8 hours later administration of the second dose and on 08Mar2021 was admitted to hospital. Patient was in hospital from 08Mar2021 till she died. Patient was positive for covid 19 on unknown date. She was diagnosed with covid when she went to ER. Patient was on a ventilator. The patient underwent lab tests and procedures which included endoscopy: gerd or abdomen problem on unspecified date, COVID test: positive on unknown date. Therapeutic measures were taken as a result of hypoxic respiratory failure and pneumonia (on ventilator). The patient died on 16Apr2021. An autopsy was not performed. It was stated that cause of death on death certificate listed as Covid 19, pneumonia, hypoxic respiratory failure. Follow attempts are needed. Further information is expected; Reported Cause(s) of Death: COVID-19; Drug ineffective; pneumonia; Respiratory failure

I took my last COVID shot on March 2021 on or abt April 15 I became short of breath and was having panic attacks. I went to doctor and was treated for Aneixty. My symptoms got worst went back to doctor and hospital er. While in the emergency room I was diagnosed w a pulmonary embolism. Never had this no famil issues w blood clots. I was hospitalize for 4 days and put on blood thinners I am still suffering from shortness of breath and panic attacks. I also lost 22 pounds in less than a month based on not being able to eat. This was a nightmare. I feel sure this was a side affect of the COVID shot no one cared to share the risk. This needs to be documented and reported I?m sure there are others.

sore arm; Hands tingled like they were asleep; she hasn't been walk a lot; woke up in the middle of the night gasping for air and stopped breathing; woke up in the middle of the night gasping for air and stopped breathing; hands get cold very easily; fingers feel funky, when she went to do anything her hands hurt and were swollen; This is a spontaneous report from a contactable consumer. This 65-years-old female consumer (patient) reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170; Expiration Date: 31Aug2021) via an unspecified route of administration on 21Apr2021 08:41, as a single dose on left arm for COVID-19 immunization. Medical history of the patient was reported as none. The concomitant medications were reported as multivitamins: (Start: Unknown Stop: Ongoing), he mentioned he was taking it from 40 years ago, does not always take, does not always remember. They were one a day gummies. It was mentioned that 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), vaccines administered on same date of the pfizer suspect if applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect and relevant tests were reported as none. The patient did not visit the emergency room. She went to physician office, but doctor did not want to see her. On 21Apr2021, the same day the patient reported that she woke up in the middle of the night gasping for air and stopped breathing. One day later, on 22Apr2021, the patient had slightly swollen balls of feet, hurts when walks, she had not been walking a lot, had sore arm, her hands tingled like they were asleep. fingertips hurt when typing and slightly swollen balls of feet, hurts when walks. On an unknown date in Apr2021 the patient was out gardening, it was hot out, her hands were cold, hurt and felt swollen. She was fighting through this, kept fighting and digging and hoeing, thought it would go away and did not, when she went to do anything her hands hurt and were swollen. She uses a mouse and 3D apocolate, a workstation on a 3D computer. She does not know if this aggravates it. She works from home, that can aggravate it, and her fingers still feel funky. She works at a computer all day, moves around a lot, but tingling, and writing too, her hands start to bother her. She was not doing much computer work, she was busy talking because she could not do much on the computer. The outcome of woke up in the middle of the night gasping for air and stopped breathing was recovered on 21Apr2021, the outcome of slightly swollen balls of feet, hurts when walks, she has not been walking a lot was unknown. The event of sore arm recovered on 23Apr2021. The event of hands tingled like they were asleep and slightly swollen balls of feet, hurts when walks were recovering. The event of hands get cold very easily and fingertips hurt when typing, fingers feel funky, when she went to do anything her hands hurt and were swollen had not recovered. The caller mentioned that she wanted to be able to travel, wanted to return to work, when asked, she felt it was a responsible thing to do. She got it to protect herself and others. But, with the reaction she had she is afraid to get second one. Comment: When she called her doctor, the doctor said to call the CDC. They couldnt help her. Thats how they worded it. Information on Lot/Batch number was available. Additional information has been requested.

The next day that evening, I started to make a squeaky wheeze. I woke up feeling extremely short of breath. I was unable to walk even a few feet without feeling SOB. I called my doctor and did a virtual visit. I was prescribed antibiotics and steroid pack (Methylprednisolone) for possible pneumonia. On 3/15/2021, I was still feeling horrible and was instructed to go to ER and was admitted for 3 days. The did blood work (normal) and X-ray of lungs which showed fluids in lungs. I was put IV of Lasix to get rid of fluids. When I was discharged with a diagnosis of heart failure and to follow up with my cardiologist who did an ECHO and stress test- it showed reduced ef rate of 25. I still have continuing heart issues and on new medications- Lasix and Entresto.

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

Slurring of speech. Went to hospital. Suspected Stroke, hospital administered tPA shot. Neurologist diagnosed a stroke caused by calcification.

Patient is a 65 yo female from home with a history of complicated ESBL E. Coli urinary tract infection, nephrolithiasis, s/p stone basket removal of stone May 2020. DM, HTN, GERD, osteroarthritis, who presented to the ED complaining of AMS. The night prior to presentation, she went to sleep with a friend staying over, and this morning the friend noted that the patient was not acting appropriately. She then called EMS, and on arrival the patient had a temperature of 101.1F. She needed 2L NC. This patient was recently evaluated in the ED on 6/06, where she was diagnosed with right-sided pyelonephritis. She was sent home on cefpodoxime and Motrin. During this current hospitalization, patient was found to be COVID positive on 6/26/21 with RLL pneumonia and E. Coli ESBL complicated UTI. She did not have a prior diagnosis of COVID. Last COVID PCR test on 6/6/21 was negative.

stridal wheezing; Ache; Arm was sore/Soreness left arm at site of injection; Low grade fever like a 100 or below/Mild fever 99.9; A-fib 40s was diagnosed, it started on Jan2021& echocardiogram: a-fib 140s, moderate mitral regurgitation a-fib on 23Mar2021; Heart failure; mild interstitial pulmonary edema; shortness of breath; I felt like I had the flu; computerised tomogram: pleural effusion; partial atelectasis; computerised tomogram: pleural effusion; partial atelectasis; Cardiomegaly; Heavy mitral calcifications; Mild coronary artery calcifications. Moderate Atherosclerotic disease; fatigue; This is a spontaneous report from a contactable other hcp. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCIN, Solution for injection,Batch/Lot Number: EL3247), intramuscular, administered in Arm Left on 29Jan2021 10:30 (AM) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hodgkin's disease, alopecia, asthma, back pain, dyspepsia, heartburn, pulmonary embolism (patient had a 2 time history of pulmonary emboli, she was having pulmonary emboli starting 15Jan2021), oral surgery - 2 teeth extracted on 13Jan2021, low thyroid due to mantle radiation, constipation. Concomitant medication(s) included levothyroxine taken for hypothyroidism; biotin taken for alopecia; finasteride taken for alopecia areata; colecalciferol (VITAMIN D3) taken for supplementation therapy; calcium taken for supplementation therapy; ascorbic acid (VIT C) taken for supplementation therapy; salbutamol sulfate (ALBUTEROL) taken for asthma, clobetasol propionate taken for alopecia areata; paracetamol, tramadol hydrochloride (ULTRAM) taken for back pain; lorazepam taken for an sleep, amoxicillin trihydrate, clarithromycin, esomeprazole magnesium (NEXIUM 1-2-3) taken for dyspepsia, rivaroxaban (XARELTO) taken for pulmonary embolism, calcium, colecalciferol (CALCIUM +D3) taken for supplementation therapy, docusate sodium, sennoside a+b (DOCUSATE SODIUM AND SENNA) taken for constipation; triamcinolone acetonide taken for rash pruritic and steroid Injections to scalp for alopecia areata. Previously she took bnt162b2 (Lot Number: EJ1686), intramuscular, administered in Arm Left on 09Jan2021 3:30 pm as dose 1, single for covid-19 immunisation and had experienced malaise, tachy irregular pulse, fatigue, shortness of breath (SOB), atrial fibrillation. The patient experienced heart failure, mild interstitial pulmonary edema, shortness of breath, patient felt like he had the flu, computerised tomogram: pleural effusion; partial atelectasis, cardiomegaly, heavy mitral calcifications, mild coronary artery calcifications. moderate atherosclerotic disease, fatigue on an unspecified date in 2021, A-fib (atrial fibrillation) 40s was diagnosed, it started on Jan2021& echocardiogram: a-fib 140s, moderate mitral regurgitation a-fib (on 23Mar2021) in Jan2021, low grade fever like a 100 or below/mild fever 99.9, arm was sore/soreness in left arm at site, ache on 30Jan2021, stridal wheezing on 18Mar2021. Reporter stated, "she received the COVID-19 Vaccine on January 9 and the second one on January 29 and about two weeks, she had an appointment with the cardiologist on (DATE). They said she was in A-fib and they put her on cardiac medications she knows to try and to get her medically to convert back into sinus rhythm and that was in February. In March she had an allergic reaction to Diltiazem they switched her to Metoprolol and then two and half months later she was still in A-fib, they sent her to electrophysiologist and Monday she had a cardioversion done. she was in sinus rhythm now but she had still having symptoms shortness of breath and fatigue. Reporter further stated, "When she did have the second vaccine which was on (DATE), she did have a few side effect that are normal. she had like a low grade fever like a 100 or below, you know the arm was sore she felt like she had the flu you know, when your body was reacting from having the vaccine so she mean in less than two days it was gone but those things are kind of normal." She took Metoprolol (treatment) because she was in A-fib they are trying to medically convert her and right now her dose had been tapered because she awasm back in sinus rhythm (Clarification unknown). So in a month she would be off of it. Dermatologist strong encouraged her to saw a Dr for symptoms of shortness of breath and fatigue and to report her symptoms to Pfizer. Diagnosed with A-Fib by cardiologist. Medications started to treat A-Fib none worked. Cardioversion 05May2021 not successful long term. Still do shortness of breath and fatigue. AV Node ablation with micra leadless pacemaker inserted into 26Apr2021 heart ventricle. Pacing. Still do shortness of breath and fatigue. CT scan with contrast done. Pleural effusion with partial bilateral atelectasis and heart failure. diuretics started and shortness of breath and fatigue improved. The patient underwent lab tests which included computerised tomogram: pleural effusion; partial atelectasis; on 05May2021 heart failure; negative for pulmonary emboli, Cardiomegaly with mild interstitial pulmonary edema and greater than left pleural effusions suggesting heart failure with atelectasis. Heavy mitral calcifications. Mild coronary artery calcifications. Moderate atherosclerotic disease. neg. PEs, echocardiogram: unknown, echocardiogram: a-fibration 140 on 18Mar2021 Lots of stridal wheezing when laying down, echocardiogram: moderate mitral regurgitation a-fib on 23Mar2021, electrocardiogram: a-fib 140's, pulmonary function test: unknown results on 01Jun2021. Therapeutic measures were taken as a result of a-fib (atrial fibrillation), shortness of breath and fatigue. Adverse event atrial fibrillation resulted in physician visit. The outcome of event stridal wheezing was not resolved, dyspnoea, fatigue was resolving, ache, pain in arm, pyrexia was resolved with 1 days duration, whereas unknown for all other events.; Sender's Comments: Based on the available information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events Afib,Cardiac failure and pulmonary edema.,Linked Report(s) : US-PFIZER INC-2021411065 same patient/drug, different vaccine dose/event

D69.6 - Thrombocytopenia (diagnosed 6/25/21) K92.2 - GI bleed (diagnosed 6/25/21) R04.0 - Epistaxis (diagnosed in on 5/24/21)

Blood clot Soreness at the injection site Minor headache Minor chest pain Fatigue Swollen feet, ankle, and legs daily Treatment: A prescription of Xareltto

Benign Uterine Polyp: I have no idea if this is related to the COVID vaccine, but I was seeing articles about vaccinated women experiencing menstrual irregularities when I experienced some unexpected vaginal bleeding after being menopausal with no bleeding for over a decade. May 3, 2021 vaginal bleeding after menopause May 10, 2021 OB/GYN Dr. appointment May 20, 2021 Vaginal ultrasound - hemoragic appearing mass in uterus found June 21. 2021 Pre-Op Dr. appointment June 30, 2021 Hysteroscopy - Uterine Polyp found and removed July 6, 2021 Notified of Lab results: Polyp was benign

Patient went into unexpected and sudden cardiac arrest and died on 18Jun2021, prior to cardiac arrest patient was short of breath and was using increased oxygen (5L to maintain at 92%); Patient went into unexpected and sudden cardiac arrest and died on 18Jun2021, prior to cardiac arrest patient was short of breath and was using increased oxygen (5L to maintain at 92%); Patient went into unexpected and sudden cardiac arrest and died on 18Jun2021, prior to cardiac arrest patient was short of breath and was using increased oxygen (5L to maintain at 92%); Patient went into unexpected and sudden cardiac arrest and died on 18Jun2021, prior to cardiac arrest patient was short of breath and was using increased oxygen (5L to maintain at 92%); This is a spontaneous report from a contactable nurse. A 65-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via intramuscular route, administered in right arm on 17Jun2021 16:00 (age at vaccination: 65 years) as DOSE 1, SINGLE for covid-19 immunisation. The medical history included muscular sclerosis, myasthenia gravis, diabetes mellitus, multiple sclerosis and covid-19. The patient had covid prior vaccination. There were no known allergies. On 18Jun2021, the patient went into unexpected and sudden cardiac arrest and died, on 18Jun2021 22:00, prior to cardiac arrest patient was short of breath and was using increased oxygen (5l to maintain at 92%). The patient was attempted for resuscitation via CPR and EMS. On an unknown date, the patient underwent sars-cov-2 test which was positive. The patient received other medications received within 2 weeks of vaccination. The patient has not been tested for covid-19 since the vaccination. The patient died on 18Jun2021 due to cardiac arrest. An autopsy was not performed. The device timestamp was 04Jul2021. Information on Lot/Batch information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, cardiac arrest, Dyspnea, Death cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest

I had a massive stroke 5days after my 2nd Pfizer vaccine.sure makes me wonder if it caused blood clots.

I received the vaccine jan 15, 2021 and I had a seizure Jan 18, 2021 at 8:30AM , My blood pressure also started going up. hospital thinks I might have had a stroke . I was hospitalized for 3 days while they ran test and put me on new meds. I am having to see a neurologists since then . I am still really tired since then and I have not been able to get back to the gym since then .

Pt was admitted with a suspected Covid vaccine reaction on 7/14/21 < 48 hrs after her second covid vaccine was received resulting in systemic inflammatory response syndrome resulting in acute encephalopathy, pulmonary edema with small pericardial effusion, high fever, lactic acidosis, acute respiratory failure and high inflammatory markers. Pt received her 2nd covid vaccine at 6pm on 7/12 and was in her normal state of heath and was just on vacation a week ago. On 7/13 she complained of being fatigued and went to bed for a nap at 3pm. At 6pm she was witnessed as tremoring all over by family. At 7:45 pm she progressed to severe confusion and EMS was called. She was found hypoxic at 80% on room air. She had a right facial droop and was confused. Her BP was 159/103, pulse 100, rr 20, glucose 307 Her temp was 100 at the scene. She went to an ER and her temp was 103.5 with RR 25-30 hr 110 and bp 122/66-161/91 with o2 sats of 89% on 4L. Her cxr showed diffuse pulm edema, CT head neg for acute abnl. Cbc with lymphopenia, hgb 17.8, lactic of 2.2, bnp 367, flu and covid neg. She was transferred to our emergency room and admitted on 7/14/21. she was noted by her family after waking up from a nap to be confused, lethargic with a right facial droop. This occurred around 6 PM on the evening of 7/14. Per the family the patient had received her second dose of the Covid vaccine at 6 PM just the day before. She had COVID-19 infection back in November 2020. She underwent work-up in the emergency room and was noted to be encephalopathic and persistently febrile with a temperature of 103 she was tachycardic and tachypneic and hypoxic. CT of the head was unremarkable chest x-ray showed pulmonary edema there was a question of a urinary tract infection and a Foley catheter was placed. CT of the brain was negative she was given IV fluids antipyretics and IV Cipro and was transferred to our hospital for further evaluation. She was treated with Ancef. She also was given IV Lasix. The following morning Patient was complaining of severe fatigue and a headache. Patient's labs were notable for polycythemia which was new with a hemoglobin of 17.1 hematocrit of 53 white blood cell count of 5.76 as well as neutrophilia and lymphopenia of 85% and 7% respectively. These were new findings compared to her previous CBCs. She also have an elevated sedimentation rate of 79 a D-dimer of 395 and a high-sensitivity CRP of 38.8. Patient's lactic acidosis resolved. By the second day of her hospitalization patient's differential improved with improvement of her lymphopenia and neutropenia and slowly improving polycythemia. Patient was noted to have hyponatremia of 130 post IV Lasix likely due to poor p.o. intake the day before. Her urine sodium was 15. Patient's blood cultures are no growth to date Covid testing was negative. She has no complaints of dysuria, or frequency. She did have a CT of the chest which revealed pulmonary edema and trace pericardial effusion. Patient's echocardiogram done the following day showed resolution of the pericardial effusion and ejection fraction of 70-75%. She was feeling better and her fatigue improved and her headache is improved and her shortness of breath is back to normal and she denies any shortness of breath and her oxygen saturation is 95% on her normal 3 L and she is felt stable for discharge to home.on 7/15/21

anaphylactic reaction; anaphylactic reaction; This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8733; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Right on 29Mar2021 08:00 (at age of 65 years old) as single dose for COVID-19 immunisation. Medical history included She has had idiopathic anaphylaxis in the past Started around 2015. No Prior Vaccinations (within 4 weeks), She is immune suppressed. Concomitant drug included: a monochromial injection that wipes out all of her eosinophils. She takes it every 8 weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6189, Expiration Date: 30Jun2021) on 04Mar2021 (at 64 years old) at left arm as single dose for COVID-19 immunization. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer-BioNTech COVID-19 Vaccine. Antibody testing is not recommended to assess for immunity to SARS-CoV-2 following COVID-19 vaccination because the clinical utility of post-vaccination testing has not been established. Experts are currently evaluating how COVID-19 vaccination may affect antibody testing results. If an immune response develops the goal of vaccination is a possibility of on antibody tests. Antibody tests indicate a previous infection and there may be some level of protection against the virus. Caller states she received the second dose of the vaccine, had an anaphylactic reaction, and was treated with steroids, and Benadryl. She is calling about the Pfizer COVID 19 vaccine. After the second dose of the COVID vaccine, she had an anaphylactic reaction. Her question is, since she had to get IV steroids and stuff, is the dose still effective. If she needs a booster, she doesn't think she can get it. She thinks that a report has already been done by the physicians at the facility, but she is not sure. Anaphylactic reaction: She was sent to the hospital by ambulance. On the way to the hospital she received IV Benadryl, and Epi. She cannot remember if they gave her steroids there or at the hospital. She knows she received steroids in the ambulance. Confirms she was not admitted to the hospital. Adverse Event was Anaphylactic reaction. Time of Onset: Provides time as started 30 minutes after she received the second dose of the COVID vaccine. Reporter seriousness for Anaphylactic reaction: Life threatening. AE requires a visit to Emergency Room. The outcome of the events was recovered on 29Mar2021.; Sender's Comments: Based on the available information in the case, the causal association between the events anaphylactic reaction, disease recurrence 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Had a major stroke 6 days after the 2nd vaccine.; This is a spontaneous report received from a contactable female consumer (patient). A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, in the left arm on 01Apr2021 at 15:15 (at the age of 65-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6206) via an unspecified route of administration, in the left arm on 10Mar2021 at 18:15 (at the age of 65-years-old) as dose 1, single for covid-19 immunisation. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 07Apr2021 at 07:30, the patient experienced had a major stroke 6 days after the 2nd vaccine. Seriousness criteria was reported hospitalization, disability and life threatening. The adverse event result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized for 43 days. Patient had received treatment for event was stroke protocols TPA (Tissue plasminogen activator), thrombectomy. On 21May2021, the patient underwent lab tests and procedures which included sars-cov-2 test (covid test type post vaccination unknown) result was negative. Outcome of the event was recovering. Follow up needed, further information has been requested. On 16Jul2021, follow-up attempts are completed. No further information is expected.

Cardiac Arrest; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; Patient was found pulseless and breathless 20 minutes following the vaccine administration.; This is a spontaneous report from a contactable other healthcare professional (HCP). A 66-year-old female patient (pregnant at the time of vaccination: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) via intramuscular at left arm on 11Jan2021 12:15 PM at single dose for COVID-19 immunization. Medical history included diastolic CHF, spinal stenosis, morbid obesity, epilepsy, pulmonary hypertension and COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19). The patient received medication within 2 weeks of vaccination included amiodarone, melatonin, venlafaxine hydrochloride (EFFEXOR), ibuprofen, aripiprazole (ABILIFY), lisinopril, cranberry capsules, diltiazem, paracetamol (TYLENOL), famotidine, furosemide (LASIX [FUROSEMIDE]), ipratropium bromide, salbutamol sulfate (IPRATROPIUM/ALBUTEROL), buspirone, senna alexandrina leaf (SENNA [SENNA ALEXANDRINA LEAF]), polyethylene glycol 3350 and morphine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient used took Penicillin, propranolol, quetiapine, topiramate, Lamictal and had allergy to them. Patient used took the first dose of BNT162B2 (lot number: EJ1685) via intramuscular at right arm on 21Dec2020 12:00 PM at single dose for COVID-19 immunization. Since the vaccination, the patient been tested for COVID-19 (Sars-cov-2 PCR) via nasal swab on 06Jan2021, covid test result was negative. Patient was found pulseless and breathless 20 minutes following the vaccine administration (11Jan2021 12:30 AM). MD found no signs of anaphylaxis. Patient died on 11Jan2021 12:30 AM because of cardiac arrest. No treatment received for the events. Outcome of pulseless and breathless was unknown. the autopsy was performed, and autopsy remarks was unknown. Autopsy-determined cause of death was unknown. It was reported as non-serious, not results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating nor congenital anomaly/birth defect.; Sender's Comments: Based on the available information this patient had multiple underlying medical conditions including morbid obesity, diastolic CHF, epilepsy, pulmonary hypertension and COVID-19 diagnosed prior to vaccination. All these conditions more likely contributed to patients cardiac arrest resulting in death. However, based on a close temporal association ("Patient was found pulseless and breathless 20 minutes following the second dose of BNT162B2 vaccine administration, contributory role of BNT162B2 vaccine to the onset of reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest; Autopsy-determined Cause(s) of Death: autopsy remarks was unknown. Autopsy-determined cause of death was unknown

At 1132, Pfizer was administered. RRT called at 1138 in the post-vaccine Recovery area for a 66 y/o female that complains of upper chest tightness and temporal tightness, pain 3/10, non-radiating. 4 RNs responded to the scene. Head-to-toe assessment completed. She reports allergies to sulfa. She took multiple morning medications today, all regularly taken. Hx of stents, HTN, HLD, DM, WPW, irregular HR. Initial vitals: HR: 125, BP: 126/80, RR: 19, O2 98% on RA. Denies nausea and SOB. At 1148, she reported that her pain was subsiding. Given medical hx, RRT activated 911 response, called by Site Manager. At this point, client calm, AA0x4, skin WNL, resp WNL. 1201 EMS arrived and report was given to them. Client taken into ambulance for EKG. ALS response provided. Nitro and ASA given. EKG revealed A-fib, HR 120, O2 96%. Client to be taken to Hospital via ambulance, truck number 490. EMS assumed care at 1214. Husband that was with client was told of plan.

RESIDENT RECEIVED THE VACCINE ON 1/20/2021, RESIDENT HAD BEEN MONITORED EVERY SHIFT AND HAS NOT EXHIBITED ANY SYMPTOMS. RESIDENT WAS OBSERVED TO BE UNRESPONSIVE WITH NO PRESENCE OF VITAL SIGNS ON 1/24/2021. RESIDENT WAS A FULL CODE, CPR INITIATED UNSUCESSFULLY. BASED ON REVIEW WITH PRIMARY CARE PHYSICIAN AND MEDICAL DIRECTOR, THE RESIDENT HAD NOT HAVE ANY OTHER EVENTS PRIOR TO RECEIVING THE COVID VACCINE 4 DAYS PRIOR TO EVENT.

I got a headache and I have had one ever since receiving the vaccine (and I'm not prone to headaches) - they come and go. I never have had these before. I had wheezing and it was getting worse- on the 30th and I went to Urgent Care 31st. Was a diagnosed with Pneumonia. Doxycline - was prescribed. I'm still wheezing but I feel fine. But I'm not wheezing as heavy as it was. I received second dose of January 14 - no other symptoms.

Sunday: tightness in chest Monday : short of breath with walking Tuesday: extreme shortness of breath Wednesday: continued worsening SOB- sent for labs/ chest xray Thursday: D-dimer back -4.53- sent to hospital CAT scan showed multiple pulmonary embolisms without cor pulmonale / ultrasound- multiple DVTs, hospitalized 01-21 to 01-23/ heparin drip, transitioned to apixiban Discharged home

Approximately 2 hours after her first COVID-19 Vaccine dose, patient began to feel right arm numbness and tingling in her hand. This progressed to right leg numbness, tingling and weakness and right lower face tingling. Patient denied any facial droop, slurred speech, confusion or dizziness. Patient reports that symptoms peaked the night of the vaccine around 9 or 10pm and had gotten better but not totally resolved. She was advised to go to the ER and was admitted. MRI showed an acute infarct in the left basal ganglia. CTA showed "short segment moderately severe narrowing of the M1 segment of the right MCA." Neurologist was consulted and determined it to be coincidental that the patient had her COVID vaccine the same day.

Death. I actually not sure which Covid Vaccine she took. I just know the date and time she took it at her local school where she worked. Died in her sleep after complaining of a headache. I talked to her around 5pm on sunday through a videochat and she seemed happy and well. But a local friend commented that she had complained of a headache late in the afternoon.

Small rash on hind that itched for a couple of hours. Once it stopped itching the rash turned in to what looked like a burn mark and the skin starting tearing and bleeding. I?ve been wearing a bandaid and I still have the mark today (1 week later), although it is slowly going away.

Within 15-minutes, the patient reported a "pulsating sharp pain" behind their right eye. EMS evaluated the patient on-site and they were found to be hypertensive (173/88). The patient proceeded to a emergency department. In the ED, the patient remained hypertensive with a mild generalized headache. They reported that their eye pain is constant but comes in waves of higher intensity. Differential diagnosis was possible stroke due to right-sided hemianopsia and right-sided ptosis. Patient was admitted and evaluated. Aspirin was administered and blood pressure was monitored prior to discharge.

Resident received the 2nd dose of the Covid vaccine approximately around 1105 by pharmacy through the pharmacy LTC partnership vaccination program. Resident had no adverse effects until around 8:00 pm she began complaining of body aches, and chills, Tylenol was given at this time. Around 9:30pm resident was sleeping in bed. Around 12:00 am the CNA called nurse into room to assess resident as the resident stated she did not feel good. Temperature at that time was 102.2, and vomiting. RN came to assess @ 1220 am She was noted to be vomiting, diaphoretic, pale and having trouble breathing. Temp was 97.3 after vomting, Pulse 53, Resp 20, o2 sats were 40-45%, unable to obtain Blood pressure, Applied 5 L of oxygen at this time and had LPN call 911 immediately. Resident was repsonsive and able to follow staff members instructions but was only answering yes or no simple questions at the time time of assessment. Paramedics arrived at 0040 and resident was sent to Hospital. @ 0130 ER nurse called to nursing facility to notify resident had coded in the ER and passed away @ 0110.

2/17/21-Anaphylaxis-15:17pm (within 30 min waiting period post vaccine), throat scratchy, moved to assessment area, HR 100, labored resp, O2 6L NRmask initiated. (ct reports similar reaction as previous anaphylaxis). 15:22pm-911 called, HR 120, Epi 0.5ml admin. 15:37pm transfer via ambulance to hospital. 02/18/2021 evening, f/u call to client by PHN, throat still feels 'weird', ct reports had 2nd Epi in ambulance, 3rd Epi in ER, plus Benedryl gel, Ct then recalled had anaphylaxis reaction in past to bee sting had ER visit, tx w/ steroids at that time. PHN recommended ct talk with PCP re epi pen order.

2 days after vaccination right thighs and right leg started to have pain similar to pain I got with polymyalgia rheumatica that I have had in past and I though it was a flare up. A couple of days after that right leg started to swell and was warm. Went to ER on 1/29/2021 and had doppler which showed blood clots from groin area to below the knee. I was placed on Xarelto at that time. Got 2nd dose and about 24 hours latter back of thighs started to hurt again. Called doctor and applied heat and elevation and had no new swelling but I remain on Xeralto. Not sure if it was related but I have had no history of blood clots. 2 years previously broke my right patella and was with brace and no weight bearing for about 8 weeks and brace for 12 weeks without clot issues. Traveled by car a couple thousand miles last year and no issues.

large knot right above the injection site/size of a half dollar/size of a silver dollar and where the needle went in was right at the base of that knot/like egg under the skin or clot; felt like she got a flu shot and could tell her arm was very sore; swelling started almost immediately after the shot/swelling was exactly underneath the injection site, just in the pronounced area/about 4 inches wide and about 2 inches high; thought maybe someone has hit a vein because it did bleed and ran down her arm; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EN6201, unknown expiration), via an unspecified route of administration on 18Feb2021 at 04:30 at a single dose for COVID-19 immunization. Medical history reported as none. Concomitant medications included tolterodine and adalimumab (HUMIRA). The patient reported that she received the COVID vaccine on 18Feb2021 at around 4:30. Firstly it was fine, she felt like she got a flu shot and could tell her arm was very sore. What concerned her was the swelling started almost immediately after the shot on 18Feb2021. She knew that was one of the symptoms. This morning and yesterday though (18Feb2021), she noticed some of the symptoms. She got a large knot that was right above the injection site. Yesterday, it was about the size of a half dollar, today it is about the size of a silver dollar and where the needle went in was right at the base of that knot. It feels like an egg under the skin or a clot. Like a knot (a hard spot underneath the skin). The patient was wondering if it was something she should be concerned about because the swelling was exactly underneath the injection site, just in the pronounced area. It was a rectangle and is about 4 inches wide and about 2 inches high and then right above that was where the needle went in. The large circle or knot was right above that and she was thinking possibly when she was given the injection she has never really bleed before. So, she thought maybe someone has hit a vein because it did bleed and ran down her arm. She got no problem. That happens at times, but she started thinking if this was a clot or it was something that is right above there because it is so pronounced, and it really hurts. The patient stated that she took some Aspirin last night and is going to take an ibuprofen in a little while. She mentioned that she takes this one pill and it has nothing to do with anything. The patient had lab work done (unknown results) that was about 3 weeks ago (2021). She also stated that she also take Humira which is a shot every 2 weeks and it said in the fact sheet that she should be concerned or be sure that she did not take any medicine that affects the immune system and Humira does weaken the immune system but she was not ask that prior to. The patient wanted to know if is that something she should be concerned about. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Ischemic stroke; not hypertensive, but supposedly is now.; Visual disturbances; Headache; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EM9810, expiry: unknown), via an unspecified route of administration in the left deltoid on 01Feb2021 14:15 at a single dose for covid-19 immunization at a Physician office. Medical history included asthma, irritable bowel syndrome, pneumonia and borderline high cholesterol. The patient's concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. The patient had her first COVID-19 vaccine on 01Feb2021 and second one is due on 22Feb2021. On 03Feb2021, the patient had a headache, but didn't think too much because it is a side effect. The headache lasted all through the weekend. Visual disturbances began 04Feb2021. She called her doctor on Monday and was seen by her doctor on Tuesday, 09Feb2021. The patient was referred to the eye center. Her headache was getting a little better. On 10Feb2021, the patient was seen at an institution, her retina and macula looked good, so she was referred to the ED. The patient was told she probably had a stroke. The patient was admitted to the hospital for an ischemic stroke. By looking at the MRI, the onset of the ischemic stroke would have been five to seven days prior, placing the onset on Wednesday, 03Feb2021, which was also the onset of her headache. There is no definitive cause of her ischemic stroke. The patient currently has an arrhythmia monitor on. MRI/MRA showed her vessels looked good. MRI showed evidence of the ischemic stroke. The patient has neurologists since being admitted to the hospital. It was thought that the headache was just because of the COVID-19 Vaccine. Causality was unknown, it was stated that they haven't found anything else as a cause. The patient's doctor stated she was borderline for high cholesterol. She was not hypertensive, but supposedly is now. The patient also had echocardiogram, EKG, manual neuro checks, and blood work but does not have the results. The outcome of the events was unknown. The has trouble reading now since the stroke.; Sender's Comments: Based on available information, the reported events are assessed as unrelated to the vaccine BNT162B2 and can be explained as intercurrent or underlying medical conditions in this elderly patient with excessive weight (BMI=29) and underlying elevated cholesterol. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Pfizer shot on Sunday am - my father noticed my mother c/o not feeling well and unable to explain why she didn't feel well. She woke up feeling well and then quickly became disoriented and vomited. She was then unable to walk or communicate appropriately. Emergency services was called and she was transported to Emergency room. She was diagnosed with a posterior brain CVA and was treated with tpa and now remains hospitalized in the ICU with expressive aphasia and vision loss.

Vaginal bleeding at 3:30 am, bloodied underwear and sheets. Gynecologist gave me an internal ultrasound of uterus, ovaries etc. were perfect. Had fatigue and aches for 24 hr. after vaccine. Also had a very bright pink, red rash covering the underside of my right arm and right chest, hot to the touch, some swelling, primary Doctor put me on antihistamines and antibiotics. Bleeding stopped. Rash and swelling is improving, still slight swelling on the underside of right arm 8 days later.

Patient was vaccinated with her second dose on Wednesday, February 24th. A family member contacted us to let us know she was sitting in a casino exactly one week later and passed out, going into cardiac arrest. The patient did pass away.

I had the second vaccine on February 13 in afternoon. I had a stroke causing expressive aphasia on the evening of February 14. I had no side effects from the first vaccine and just soreness in arm of injection after the second vaccine. I realize that the stroke could coincidental but thought I should report it just in case for information in the event others had similar event.

NOTHING LOCALLY AT TIME OF IMMUNIZATION. NO PROBLEM 15-30MINUTES LATER. WAS INFORMED SHE WAS FOUND DEAD THE NEXT MORNING.

Triggered atrial fibrillation within 4 hours after receiving 2nd dose. Double-loading Amiodarone for one week after speaking with doctor's office on 3/10/21 (3/10/21 - 3/16/21) and for another week (3/16/21 - 3/22/21) did not convert my heart back to normal sinus rhythm. During Kardia readings (taken 2-3 times per day), heart beat jumps back and forth repeatedly in the range of 92 to 110+.

Pain in the left arm; Atrial fibrillation; Tired; This is a spontaneous report from a contactable consumer (patient). A 66 years old female patient (weight: 107.95 kg, height: 165 cm) received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, in the left arm, on 04Mar2021, at 16:50, for COVID-19 immunisation. Relevant medical history included atrial fibrillation from Jan2016 and ongoing and cardiac ablation on an unspecified date, in Feb2020 (she had her 2nd ablation in Feb2020, since then she has had intermittent episodes of atrial fibrillation. She stated prior to the second vaccine she had been in normal sinus rhythm for 8 days). Patient stated that she had a sister who had an arrhythmia problem. The patient previously, on 10Feb2021, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) in the left arm, at single dose, for COVID-19 immunisation. Patient stated that she had no problem with first dose. The patient received concomitant medications (unspecified). On 04Mar2021, at 21:00, the patient experienced atrial fibrillation and on 04Mar2021 she was tired. On 05Mar2021, she developed pain in the left arm. The patient recovered from pain in arm on 05Mar2021, from tiredness on 07Mar2021, while did not recover from atrial fibrillation. The information on the lot number has been requested.

Principal Final Diagnosis: Acute saddle pulmonary embolism with acute cor pulmonale (HCC) Secondary Diagnoses: Active Hospital Problems Diagnosis Date Noted ? Acute saddle pulmonary embolism with acute cor pulmonale (HCC) 02/09/2021 ? Acute thrombus of right ventricle (HCC) 02/09/2021 ? Right-sided epistaxis 02/09/2021 ? Melena 02/09/2021 ? Essential hypertension 02/28/2020

Patient presented to the ED on 3/4/2021 with left facial droop, left-sided weakness, and dysarthria that started upon awakening that morning. Patient found to have an ischemic stroke and ultimately admitted to hospice. Patient expired on 3/10/2021.

phlebitis in my Right leg; small blood clot; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 09Feb2021 (Batch/Lot Number: EL9269) as single dose for covid-19 immunisation. Medical history included many allergies. The patient has no COVID prior to vaccination. The patient had other medications in two weeks but no other vaccine in four weeks. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9263) on 20Jan2021 at 10:00 administered in the right arm for Covid-19 immunization. On 20Feb2021 at 12:00 (also reported as "in February"), the patient had a phlebitis in her right leg, a week later (Feb2021) a vascular surgeon office did an ultrasound and found a small blood clot. The events resulted in doctor or other healthcare professional office/clinic visit. The events were treated with Eliquis BID (twice a day) for 45 days. The patient was not tested for COVID post vaccination. The outcome of the events was not recovered.; Sender's Comments: A causal relationship between BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) and the event thrombosis cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .

Afib episodes increased to daily, lasting longer and more severe for 3 weeks and now random heart palpitations. 2 weeks after second dose-Hives appeared and disappeared for 2 days.

Acute on chronic systolic congestive heart failure; PVC's (premature ventricular contractions); SOB (shortness of breath)

Jerking movement were to hands when observed during med pass. Tonic clonic movements were assessed for approximately 2 minutes. Code called and patient sent to ER via 911 No history of Seizures she has ongoing seizures. there is a significant decline in her mental status. She is not speaking. She has to be fed. She is not walking.. She is scheduled to see a neurologist in June 2021.

Had a stroke with expressive aphasia; Had a stroke with expressive aphasia; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 13Feb2021 14:00 (lot number: EL9264) as single dose at the age of 66 years old, for covid-19 immunisation. Medical history included type 2 diabetes mellitus, hypertension, spinal stenosis, arthritis and allergies to sulfa. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included insulin human zinc suspension (HUMULIN U), metformin, pioglitazone hydrochloride (ACTOS), fish oil, tocopherol (OMEGA 3) and valsartan; all taken for an unspecified indication, start and stop date were not reported. The patient previously took bydureon, codeine and celebrex and experienced drug allergy with these medications. The patient previously received first dose of bnt162b2 on 23Jan2021, at the age of 66 years old for COVID-19 immunization (Product: COVID 19, brand: Pfizer BIONTECH, lot number: EL3247, administration time: 03:00 PM, vaccine location: right arm). The patient did not receive any other vaccines four weeks prior to COVID vaccination. The patient had a stroke with expressive aphasia on 14Feb2021 20:00. The patient was hospitalized due to stroke with expressive aphasia for 5 days. The events resulted in emergency room/department or urgent care and hospitalization. On unspecified dates, the patient underwent lab tests and procedures which included computerised tomogram (CTS), laboratory test (labs), magnetic resonance imaging (MRI), and tPA (plasminogen activator inhibitor); all with unknown results. Other tests include: negative COVID test (nasal swab) on 16Feb2021 and negative COVID test (blood test) on 03Mar2021. The patient had speech therapy as treatment for the events. The patient recovered with sequelae from the events.; Sender's Comments: The reported stroke with expressive aphasia is assessed as unrelated to the administration of vaccine BNT162B2 and can be explained as intercurrent medical condition in this elderly patient with underlying diabetes mellitus, hypertension and other comorbidities. 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.

stroke; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266 and expiration date not reported) via an unspecified route of administration, administered in the left arm on 24Feb2021 16:15 as a single dose for COVID-19 immunisation. Medical history included LBBB, HTN, and high cholesterol. The patient is not pregnant and has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient had the first dose of the vaccine on 24Feb2021 and had stroke on 09Mar2021 16:00 with no CVA history. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Hospitalization. The patient was hospitalized on an unspecified date for the event for 1 day. Treatment was given in response to the event which included CT Scan and MRI. The patient underwent COVID test post vaccination via nasal swab on 09Mar2021 and was negative. The outcome of the event was recovering. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6208) on 17Mar2021 for COVID-19 immunization.

She had a stroke on 3/28/2021 due to a blood clot in her brain; She had a stroke on 3/28/2021 due to a blood clot in her brain; Administration_date=08/03/2021 number=1/administration_date=22/03/2021 number=2; Administration_date=08/03/2021 number=1/administration_date=22/03/2021 number=2; This is a spontaneous report from a contactable consumer reporting for herself. A 66-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: Unknown), via an unspecified route of administration, administered in Arm Right on 22Mar2021 17:45 (vaccinated at the age of 66 years old) as single dose for covid-19 immunisation. Patient received the first dose on 08Mar2021. Medical history included diabetes; obesity; high blood pressure, iodine allergy. The patient's concomitant medications were not reported. The patient experienced she had a stroke due to a blood clot in her brain on 28Mar2021 18:30, The patient was hospitalized for she had a stroke due to a blood clot in her brain (cerebrovascular accident) for 2 days. Patient visited Emergency room/department or urgent care for events a stroke due to a blood clot in her brain and received treatment. Outcome of event a stroke due to a blood clot in her brain was not recovered. Information about lot/batch number requested.

My mother became very ill-- labored breathing, chills, slight fever, body aches, throwing up and diarrhea throughout the weekend. By Sunday (48 hours later), she was having black outs and ended up passing away on Monday, March 22, less than 72 hours later. She was fine without symptoms prior to the shot.

four days after second shot, severe stomach pain, fevers, trouble urinating, chest pain, . turned into kidney infection, blood infection and having AFIB, need for pace paker.

On 3/24/21, just three days after receiving my second Pfizer vaccine, I started noticing excruciating pain in my left calf. I managed the pain with Tylenol, but as it continued to get worse and debilitating, I saw my doctor on 3/30/21 who immediately scheduled an ultra sound. On 3/31/21 at 9:00 am, I had the ultra sound and the results were DVT (BLOOD CLOT). SEE DETAILED RESULTS IN ITEM 19.

Severe abdominal pain,nausea,emergency hospital visit,atrial fibrillation,thrombosis,left.kidney infarct.admittance to local hospital for 5 days and ongoing follow up testing and multiple specialist visits for months

Received second shot on April 2@ 1130am. Started with diarhhea and vomiting's on April 6 at 3:30 am. Continued to 4:30 am on April 10. Slight elevated temperature at 99.1 . On morning of April 11 couldn't put pressure on right side, leg and arm, facial numbness. Went to er and they said I was having a stoke, transferred to hospital. MRI done verified Stroke with blood clot to Left thalamus Sent home and will be receiving PT and OT.

Died; The initial case was missing the following minimum criteria: Reporter with no first-hand knowledge. Upon receipt of follow-up information on 13Apr2021, this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer reported that a 66-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Jan2021 (at the age of 66-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Dec2020 for COVID-19 immunisation. The patient died on 11Jan2021; the cause of death was unknown. On 11Jan2021, the patient experienced cardiac arrest and breathless with outcome unknown. The patient was found pulseless and breathless 20 minutes following the vaccine administration. MD found no signs of anaphylaxis. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Died

Hospitalized with a TIA (transischemic attack) slurred speach, cognitive abilities effected, left-sided weakness

Anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm on 02Apr2021 09:45 as single dose for COVID-19 immunisation. Medical history included type 2 diabetes, hypothyroidism, and allergy to: shellfish, penicillin, all narcotics, mold, catfish, vaccinium berries, peaches, somegrass and trees. Concomitant medications included levothyroxine sodium (SYNTHROID), cholecalciferol (D3), famotidine (PEPCID AC), biotin, and salbutamol sulfate (VENTOLIN ACCUHALER). On 02Apr2021 10:00, the patient experienced anaphylaxis. Treatment for the event included Ventolin, steroids antihistamines and nebulizer. The event result in Emergency room/department or urgent care. 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 had not been tested for COVID-19. Outcome of event was recovering. Information about lot/batch number has been requested.; Sender's Comments: Due to a strong drug-event temporal relationship the company deems there is a reasonable possibility that the reported anaphylaxis is related to BNT162b2.

Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Soreness to left arm, hurts in chest around breast, back, shoulder blade; Unable to lift arm, pain makes her catch her breath/ Difficult to take a deep breath; Thought she was having a heart or panic attack; Stress, heart rate, panic; soreness from the shot; Stress, heart rate, panic; Stress, heart rate, panic; Stress, heart rate, panic; Tingling in hands and down the arm; crying; This is a spontaneous report received from contactable consumer (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 66-years-old on 22Mar2021 13:57 (Lot Number: EN6208) as single dose for COVID-19 immunization. Medical history included migraine. Concomitant medication included topiramate taken for migraine from 15Mar2021 and ongoing. The patient had her shot last Monday afternoon and had some soreness from the shot on Mar2021. On Tuesday, 23Mar2021, it began getting sore back behind her shoulder blade; it has gotten progressively worse, and now she can barely lift her arm. She does not know if it's a muscle or has to do with the vaccine, or if she pulled a muscle although she has not done anything. It's difficult to take a deep breath, she can't lift her arm, it is sore. It hurts down into her chest and around her breast; also, hurts around on her back where her shoulder blade is. She has tried heat compress, cold compress, and massage the area. It seems like the pain will ease up but then it starts again. She becomes stressed about it and her heart rate starts panicking. She gets tingles down the arm. Thought she was having a heart or panic attack. It has gotten worse as the week has progressed. It was worse on Sunday; even worse on Monday; worse yesterday and she was crying. She has also been stressed at work. Doesn't know whether to go to the doctor or an urgent care, or if she needs to. The patient is 66 years old and says she is in fairly good health. Right now she is unable to lift her arm and has tingles in the hand and down the arm. The pain makes her catch her breath. If this gets much worse she is going to go have it checked out. Again mentions that she has been having stress. It does seem to be a little worse. The patient experienced thought she was having a heart or panic attack on Mar2021, stress, heart rate, panic on Mar2021, soreness from the shot on Mar2021, soreness to left arm, hurts in chest around breast, back, shoulder blade on 23Mar2021, unable to lift arm, pain makes her catch her breath/ difficult to take a deep breath on Mar2021, tingling in hands and down the arm on Mar2021, and crying on Mar2021. The outcome of the event Soreness to left arm, hurts in chest around breast, back, shoulder blade was not recovered while for the rest of the events was unknown. Prior Vaccinations (within 4 weeks) was None. She had an unspecified shot but reiterated no vaccines. No AEs following prior vaccinations.

anaphylaxis; This is a spontaneous report received from a contactable nurse. A 66-years-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: Unknown), 1st dose via intramuscular route of administration, on 02Apr2021 09:30 AM (at the age of 66-years-old) as single dose for COVID-19 immunisation. Patient's medical history included asthma, GERD. Concomitant medications were not reported. The patient previously took keflex, peanut, fentanyl, pcn ms and experienced known allergies. On 02Apr2021 09:30 AM, the patient experienced anaphylaxix chest/throat tightness, which resulted in emergency room visit. Treatment received for the adverse events included epi, albuterol, and Benadryl. It was unknown that the patient was diagnosed with COVID-19, prior to vaccination and whether the patient had been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event anaphylaxis and the suspect drug BNT162B2.

low level anaphylactic reaction half an hour after first shot; This is a spontaneous report received from contactable consumer (patient) via medical information team. A 66-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: UNKNOWN) via an unspecified route of administration on 21Mar2021 (at the age of 66-year-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 21Mar2021, the patient had a low level anaphylactic reaction half an hour after first shot. Patient's second dose was scheduled for 21Apr2021. The outcome of the event was unknown. Information on the lot/batch number has been requested.

blood clot in her right ankle; varicose vein in her right ankle and it started to hurt; varicose vein in her right ankle and it started to hurt; ankle on her right side started swelling; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on arm left on 26Feb2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9809 and expiry date: 30Jun2021) on left arm on 05Feb2021 for covid-19 immunisation. The patient experienced blood clot in her right ankle, varicose vein in her right ankle and it started to hurt, ankle on her right side started swelling, all on an unknown date. All events caused patient physician office visit. Treatment received for all events. It is reported that she is calling about the Covid 19 vaccine. She wanted to report that she developed a blood clot in her right ankle. She went to the doctor yesterday on 06Apr2021. She would like to add she has no prior history of any type of blood issues. The doctor she saw thought that the blood clot and the Covid 19 vaccine could be related but would not commit to saying so directly. She started having issues about 6 days after the second Covid 19 vaccine. She doesn't exactly remember when, maybe the 04Mar2021 or 05Mar2021. She ignored the issues attributing them to over exercising. She reached a point where she couldn't ignore the issues anymore and went to the doctor. Caller clarifies she has a varicose vein in her right ankle and it started to hurt then her ankle on her right side started swelling. She only payed attention to her ankle when it got worse. The last 3 weeks have been awful. She would like it known that she does not lead a sedimentary lifestyle. She rides her bike 60 miles a week and walks 10 miles a week. She's always moving. This is unusual for her. The doctor she saw diagnosed her with a blood clot and he did a sonogram in his office. She has been prescribed Xarelto 15mg tablets. Take 2 tablets twice daily for the first 21 days then on the 22nd day start taking one 20mg tablet once daily. The patient underwent lab tests and procedures which included sonogram: unknown result on 06Apr2021. The outcome of the all events was unknown.

Per the nursing home facility patient received her second dose of vaccine on 01/14/2021 but it was not listed on KYIR. Patient tested positive on 04/14/2021 and died on 04/16/2021.

Anaphylaxis reaction immediately post-vaccine; Difficulty speaking; hoarseness; tightness in throat and chest; tightness in throat and chest; dizziness; disorientation; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08Mar2021 17:30 as single dose for covid-19 immunization in an hospital. Medical history included reaction to preservatives in foods, products, and medications from an unknown date. The patient's concomitant medications were not reported. The patient previously took sodium metabisulfite and experienced anaphylaxis. No other vaccines taken in four weeks. No COVID-19 prior to vaccination. On 08Mar2021 18:00 the patient experienced anaphylaxis reaction immediately post-vaccine, difficulty speaking, hoarseness, tightness in throat and chest, dizziness, and disorientation. The events required emergency room and physicians office visit and were considered life threatening by the reporter. The patient was treated with Epinephrine, Benadryl, Prednisone, and Pepcid. The patient was tested for COVID-19 via nasal swab post vaccination on 08Mar2021 with a negative result. The outcome of the events were recovered with sequel. Information about lot/batch number has been requested.

Patient began to experience minor pain in upper left leg in mid-April; patient noticed extreme swelling and discoloration in left leg evening of 05/01/2021; Admitted to ER morning of 05/02/2021. Diagnosis: Acute deep vein thrombosis (DVT) of left lower extremity; no family history of blood clots and no falls reported by patient. DVT resolved after 24 hours of catheter directed thrombolysis. Residual nonflow limiting disease still present in the below-knee deep veins and popliteal vein with good collateralization of the deep venous system. Minimal residual disease still present in the femoral vein without flow limitation.

This 66 year old female received the Covid shot on 3/26/21 and went to the ED on 4/17/21 and was admitted on 4/17/21 with the following diagnoses listed below. R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - Acute kidney failure, unspecified R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction

deep vein thrombosis left leg/Vascular u/s showed clot from the ankle to the groin in left leg; This is a spontaneous report from a contactable nurse (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation, administered at the hospital. Medical history included prediabetes, relapsing polychondritis, obesity, intolerant to gluten and cow's milk protein, and penicillin allergy. The patient is not pregnant at the time of report and vaccination. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included fish oil; ergocalciferol (VIT D); methylfolate; metformin; and desvenlafaxine succinate (PRISTIQ). On 12Jan2021 at 19:00, the patient's left ankle swelled double normal size. On 13Jan2021, left leg swelled. On 14Jan2021, patient knew it was a deep vein thrombosis left leg based on pain and swelling and past experience but waited till her day off on 15Jan2021 to seek medical care. Vascular u/s (ultrasound) on 15Jan2021 showed clot from the ankle to the groin in left leg. Sent to emergency department and started on Zarelto x 6 months for long term anticoagulation. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received the second dose on 01Feb2021 at 16:45. Outcome of the event was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event deep vein thrombosis 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 Committees, and Investigators, as appropriate.

SOB resulting in near respiratory arrest, pt intubated.; SOB resulting in near respiratory arrest, pt intubated.; This is a spontaneous report from a contactable other hcp. A 66-years-old female patient received BNT162B2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 30Apr2021 11:30 (Batch/Lot Number: EW0158) as single dose for covid-19 immunization. Medical history included drug hypersensitivity to sulfa from an unknown date. It is unknown that the patient received any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. On 30Apr2021 the patient experienced sob resulting in near respiratory arrest, pt intubated. The event resulted in Emergency room/department or urgent care. The outcome of the events were unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of SOB results in near respiratory arrest cannot be excluded but also consider relevant medical history and concomittant drugs and drug history. 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.

pericardial effusion tamponade; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 (Batch/Lot Number: EN8208) at the age f 66 years old as 2nd dose, single for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 31Jan2021, (Lot Number: EL9264) in the right arm at the age of 66 for COVID-19 vaccination. The patient reported that she began having signs and symptoms on 29Mar2021; heavy weight in throat like there was a softball in her throat; pressure in that area when she bent over; chest tightness; difficulty breathing; a lot of chest pain; chest stiffness; sharp stabbing pain in upper left chest. The patient stated that it took 13 days and 2 trips to the ER and multiple Doctor calls before they could diagnose what was wrong. She had visited her general doctor who thought she had an embolism and sent her to the Emergency Room on her second visit. They did a D-Dimer test, which they hadn't done on her first Emergency Room visit. The patient was diagnosed with pericardial effusion tamponade on 08Apr2021 as confirmed with the echocardiogram performed on 09Apr2021. On 09Apr2021 they removed the fluid, 700cc of blood, surrounding her heart. The patient was in the ICU from 08Apr2021 to 16Apr2021. The patient stated that she was hoping she would be able to transfer to a hospital but she was in too bad of shape to be transferred. The patient reported that she has some mild symptoms, residual symptoms, some pain in chest and some tightness, but it was much better now. She had an echocardiogram a week after getting out of the hospital which showed no fluid now. The patient was placed on medication. The outcome of the event was recovering. Follow-up attempts are needed. No further information is expected.

get sore arm; Anaphylactic reaction; Shortness of breath; look miserable; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Right on 09May2021 (Lot Number: EW0177; Expiration Date: Aug2021) at single dose for COVID-19 immunization. Medical history included asthma since she was 8 years old, when she was a child her asthma was really bad and then she would say after 2004, she would say she went to chemotherapy and then 2005 her asthma got a lot better, didn't have it really bad as she used to, one doctor said he had heard that from patient they go through the chemo and their immune system change, she carried her little inhaler, but she don't have (incomplete sentence), she had asthma but not really bad, she was not like walking around every day with asthma packs but she have asthma and she keep little inhaler, for eg; if there is lot of pollen in air then she will need to take out her inhaler; breast cancer; seizure; hypertension, high cholesterol. Concomitant medications included zonisamide taken for seizure, lacosamide (VIMPAT) taken for seizure, losartan taken for hypertension, atorvastatin taken for high cholesterol, all start and stop date were not reported. Some years ago when she in 2005 when she was on the end like she said its 2005 and she was right on the end of being treated for breast cancer. she was taking, the doctor put her on Tamoxifen and she woke up one morning to really short of her breath and she thought it was her asthma, so the lady she was staying with said you look miserable and she said let her get back on the store and have her take her to the ER she said call now and it turned she had a blood clot in her lungs but 'Dr PRIVACY' (not spelled) who was treating her, he was a cancer specialist he said PRIVACY she was so proud of her, he said that she got to take you off the Tamoxifen, it was that Tamoxifen that caused blood clot in your lung. A blood clot in the lungs was the side effect of the Tamoxifen. Tamoxifen was one of the drug they give women who have had breast cancer and are right at the end of the treatment and put us on Tamoxifen and she ended up with a little bit of blood clot in her lungs. He said that was one of the effects of Tamoxifen. So, that was like in 2008, 2009 it was 12 years ago, could have 11 years ago but this goes to show her body may have potency for allergic reaction. The patient stated she had short of her breath because she did have allergic reaction shortness of breath with Pfizer Vaccine first dose at a pharmacy yesterday 09May2021, had been given Prednisone so. She did shortness of breath about 45 minutes after she took it because we had to sit there about she would say we were sitting there about 20 minutes and he finally said well you all can get up and leave and then about say 15 minutes later she start getting shorter and shorter of her breath. " The patient stated, she just needed to Pfizer certainly reporting acting as if this was just a completely safe vaccine there are unsafe reaction to this vaccine so she wanted to get this going okay, she was 66 years old she end up going to the ER, they didn't give her Epipen' (not clarified further) so that's when she started to get sore arm, she had an anaphylactic reaction to this drug. Now if this was the wrong number to report it to then she would call to get to agency she needed to report it to. she was on the Prednisone now. Sometimes it was difficult for she to breathe, so the emergency room they 'have' (not clear) she up with enough medication now, so she had got plenty of medication now." She stated it just happened yesterday, when she saw on the news that they hadapproved it to be for children and it bothers me that they, this was just a break simple drug no very safe. Yesterday when she first started getting short of her breath she was in denial and didn't want to because she was really started shorter of my breath and the pharmacist that administered he even said he knew that it was the reaction to the drug because she was full animated before he administered the vaccine because she was sitting there talking to the two ladies and you know jabbering and remember the days because of flu shots and how the government used it, they didn't wanted knowledge when people talked about how the flu shot (Unspecified Shot) made them sick and she was just jabbering so he knew it was reaction to the vaccine. Here was this lady 'who was so animated and talking and now she can barely hold her head up' (not clarified further). Patient confirmed Prednisone as treatment. As for the treatment patient stated, "Took the 2 Prednisone and what happened was, if I wasn't even going to go get Prednisone, but the shortness of breath was going transient, what I mean is first of all I talk and I do fine and then all of a sudden I get short of my breath again and then looked like I had a good night and then I woke up and my lungs tightened up again and then earlier this evening I called on phone and tell them I have to take Prednisone because my breath was getting short again." Prednisone details were 10 mg 4 tablet by mouth every day for 5 days then 2 tablet every day for 3 days, so 1 every day for 2 days. As for other medications: patient stated she was on seizure medications daily. She was on treatment for asthma, she had a little inhaler she keep in her purse for eg; if there's pollen in the air, when she got out and then maybe get short of her breath if there's pollen in the air yeah she need her little inhaler, but she was on daily treatment for her seizures she was on 800 mg a day for the seizures, Zonisamide and Vimpat. In fact that day she wouldn't take any other medication because she thought well she was not taking any other medication' (not clarified further) to mix it with this vaccine. Normally she take the 25 mg for high blood pressure but she won't take it that day she think it's called Losartan or something. Little bit of high blood pressure they cut that down because her blood pressure had gotten, she had some high blood pressure yes it's called 25 mg of Losartan. Yeah she thought, she won't take it that morning because she though well just lay off all of that stuff that day and so we can take the vaccine, 'mix none of that with vaccine' (not clear), that day the only medication that she was taking was her seizure medication (Zonisamide and Vimpat) because you can't skip medication but the Losartan and Atorvastatin that's for high cholesterol she won't take that either that day. The asthma now, she did have asthma but it's a kind of that's one the things that you have it but you are not on daily medication for it. She do keep her inhaler with because sometimes she go in buildings where they have air condition on really high and it gets to her lungs. In fact when this happened and the guy wanted to call 911 we decide well let's see if new inhaler (Unspecified Medication) worked and it wasn't quite rescuing her lungs like it should." For Vimpat details patient stated, it's a pill (formulation not clarified further), it's 100 mg so she took one in the morning and one in the evening. For Zonisamide details patient stated, Each capsule was 100 mg, so she take two 100 in the morning and two 100 before she go to bed." As for lab Test patient sated, "Just had a MRI but no dye just the plain MRI with no dye or anything. Had MRI without dye, no dye." hen probed for the MRI result, consumer stated, "No because this was the seizure doctor ordering that." As for date of MRI patient stated, "That was on the 4th I think, but what was the MRI have to do with having a reaction to this vaccine, because the MRI. Doctor want specifically had no dyes it was just no dyes but that was the doctors that treat me for seizure he wanted the MRI done, yeah this was the 4th of May." When probed if adverse events are improved, worsened or persisting, consumer stated, "today you know just a short of the breath I am really short of my breath but now when I have taken the Prednisone I am breathing a lot better, breathing so much better yes, you can mark improve (not clarified further)." The outcome of the event shortness of breath was recovering, of other events was not recovered.

Patient presented to the ED on 4/23/21 and was subsequently hospitalized for Acute on chronic respiratory failure with hypoxia and hypercapnia. Patient presented to the ED on 5/5/21 and was subsequently hospitalized for hypertensive urgency and CVA. Patient died on 5/9/21.

Patient is a 66 y.o. female with an unknown PMHx admitted with DKA and found to have thrombocytopenia, an intraparenchymal bleed on Head CT 2/2 to dural venous thrombosis. Course also complicated by saddle submassive PE w/ + biomarkers and mild RHS. Given unclear etiology of thrombocytopenia, venous thrombosis, and PE, suspect a precipitating/underlying etiology and cannot rule out possible occult malignancy, autoimmune disorder or alternative hypercoagulable state such as APLS. Possibly bacteremic given GPB and Staph on blood cx, though likely contaminant. DKA resolved, anion gap is closed, continued monitoring of glucose and insulin adjustment .OB/Gyn following for heavy vaginal bleeding and possibly gyn malignancy workup, endometrial biopsy pending. Heme also following.

Diagnosed with a stroke; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6204), via an unspecified route of administration, administered in Arm Right on 12Apr2021 14:00 (received at the age of 66-years-old) as 2ND DOSE, SINGLE for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccine in four weeks prior to receiving bnt162b2. Medical history included hypertension, high cholesterol, anxiety and allergy to penicillin. The patient had no history of COVID-19 and was not tested for COVID-19 post vaccination. She was not pregnant. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported; fluoxetine (FLUOXETINE) taken for an unspecified indication, start and stop date were not reported; atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EN6198), on 22Mar2021 14:30 (received at the age of 66-years-old) for COVID-19 immunization. The patient previously took macrodantin and metronidazole in which she experienced allergy. On 13Apr2021 17:00, the patient started feeling right-sided leg weakness. And by Thursday, 15Apr2021, she had arm weakness and a mild right mouth droop. She was diagnosed with a stroke on 17Apr2021. The patient stated that she thought for three days it was just a vaccine side effect and would get better, but it ended up getting worse. The adverse event stroke started on 13Apr2021 at 17:00. The adverse event resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. The patient was hospitalized for 6 days. It was unknown if the patient received corrective treatment. Outcome of the event was recovered with sequel on an unspecified date.

increasing in episodes of A-Fib strong enough where she was aware of them; peripheral neuropathy was greatly worsened; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 14:30 (Lot Number: EW0172) as 1st dose, single dose for covid-19 immunisation. No pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included ongoing Peripheral neuropathy from chemo, asthma, ongoing A-Fib, Known allergies: Yes. Concomitant medications included unspecified drugs that the patient received within 2 weeks of vaccination. On 23Apr2021, the patient experienced increasing in episodes of A-Fib strong enough where she was aware of them. She slips into and out of it many times daily but am usually not aware when it occurs. Since the vaccine these episodes are such that she was well aware of them. Her electrophysiologist had others reporting same. Also, peripheral neuropathy was greatly worsened. No treatment received. The events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The second dose of BNT162B2 was on 14May2021 03:00 PM (lot number: EW0167, Vaccine location: Right arm) for covid-19 immunisation. Outcome of the events was not recovered. The case was reported as non-serious.

K92.2 - GI bleed I26.99 - Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type (CMS/HCC)

Rashes and those rash become swollen; face become swollen; itching; very painful; Lips become swollen; She is bleeding so much of bleeding from there; This is a spontaneous report from a contactable consumer (patient's daughter). A 66-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration on 12May2021 (Batch/Lot Number: EW0172) as 2nd dose, single for covid-19 immunisation. Medical history included diabetes, high blood pressure and high cholesterol. Concomitant medications included amlodipine; insulin lispro (HUMALOG), empagliflozin, linaglipin, metformin hcl (TRIJARDY XR) and lovastatin all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on unspecified date for Covid-19 immunization. On 15May2021, 2 days after vaccine administration, it was reported that the patient's body reacted to the vaccine. The side effect which the patient got was in the form of rashes and those rash become swollen and her face become swollen and is very itching and very painful, her lips become swollen. The daughter went to almost all doctors in urgent care and they are giving basically allergy medication but the allergy medications that they are giving is making worse. And the doctor says this is new for them so they don't know why her body is reacting to the vaccine like this. The patient was administered with treatment medications which includes Prednisone, Pepcid, Benadryl, Claritin, she also got Solu-Medrol, which the daughter reported was making the events worse and now the doctors ae not doing anything. Because the patient was given steroids her sugar and WBC came up. The daughter also reported she is bleeding so much of bleeding from there. The patient underwent blood test on 15May2021, 16May2021 and 17May2021 which were normal. The outcome of the events was unknown.

I30.9 - Acute pericarditis, unspecified J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia

Patient presented to the office with SOB and chest discomfort on 5/11. She was sent to the ED and diagnosed with BIL DVT and BIL PE

Bleeding; Spotting; This is a spontaneous report from a contactable consumer(patient). A 66-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 08-FEB-2021 12:00 at the 66 years old at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The patient was not pregnant.There was no other vaccine in four weeks. On 22Feb2021 the patient experienced Bleeding, Spotting with outcome recovered in 2021. All of events resulted in Physician Office Visit. There was treatment for events. The patient underwent lab tests and procedures, which included Biopsy : Unknown results; Ultra sounds: Unknown results. There was no COVID prior vaccination. There was no COVID tested post vaccination. Information about Lot/Batch number has been requested.

I had a complete hysterectomy in March of 2021 with no complications . Over 2 months later, 13 days after the vaccine I started vaginal bleeding which is inexplicable because I no longer have a uterus.

Coronary artery occlusion; get's weak easily/ weakness; dizziness; Heart attack; This is a solicited report from non-contactable consumer (patient) based on the information received by Pfizer. (Mfr. Control No.: 21K-163-3889347 -00). A 66-years-old female received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number and expiry date were unknown) via intramuscularly on 03Mar2021 (at age of 66-years-old) as a single dose for covid-19 immunisation and adalimumab (HUMIRA, Solution for injection in pre-filled pen) via subcutaneous route at 40mg/ 0.4ml (daily dose: 1, Citrate free: 40 mg, 1 in 2 week) for moderate to severe chronic plaque, psoriasis, psoriatic arthritis, ongoing since Jan2019. Medical history included heart disease, high blood pressure, slightly elevated cholesterol level from 2005, supplement, cartilage disease, thyroid disease, anxiety, tobacco use, one pack of cigarettes (from 1966 to 2016), recurrent difficulty in sleeping since 1971, alcohol use from 1971, one glass of wine a glass of bourbon from 1972), recurrent joint pain from 2005 and rheumatoid arthritis. Concomitant medications included acetylsalicylic acid (ASPIRIN) and clopidogrel both for heart disease; metoprolol and lisinopril for high blood pressure; atorvastatin for cholesterol; clobetasol via topical route, methotrexate, ibuprofen and omeprazole for an unspecified indication; folic acid and colecalciferol (VITAMIN D3) both as supplement; glucosamine for cartilage disease; levothyroxine for thyroid disease and naproxen for anxiety. Patient had previously received first dose of vaccine (lot number and expiration date were unknown) via intramuscularly on 17Feb2021, and on same day experienced light headed/ dizziness and recovered on 19Feb2021. On 28Apr2021, patient had heart attack and get's weak easily/ weakness. On 29Apr2021, patient had Coronary artery occlusion. On 28Apr2021, the patient was hospitalized for three days due to heart attack. On 29Apr2021 angioplasty procedure was performed and stent was laced that her artery was 99 percent blocked. She also stated that her heart muscle did not show any damage. She was monitored her electrocardiogram after the procedure and was given blood thinners, blood pressure medication and medication for cholesterol. She was scheduled for a follow up with her cardiologist on 26May2021. She was also advised do cardiac rehabilitation for 12 weeks. The alternate etiology as per the reporter for the event slightly elevated cholesterol level was weight. The alternate etiology as per the reporter for the event light headed and dizziness was COVID-19 vaccination. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Blood cholesterol test was performed in Apr2021 and result was 130. The reporter's causality for the events of cardiac artery blocked and get's weak easily was not provided. The reporter's causality for the event(s) of heart attack and light headed/dizziness with adalimumab (HUMIRA) 40mg/0.4ml was no reasonable possibility. The opinion was that there was no reasonable possibility that the events of cardiac artery blocked, heart attack, get's weak easily and light headed/dizziness are related to adalimumab (HUMIRA) 40mg/0.4ml. The action taken in response to the events for adalimumab (HUMIRA) was unknown. The outcome for event weakness was resolving and for light headed/ dizziness was resolved on 19Feb2021, coronary artery occlusion and heart attack was resolved on 30Apr2021. Causality for Covid-19 Vaccine For Coronary artery occlusion Causality as per reporter (Drug/Vaccine): Not assessable For heart attack Causality as per reporter (Drug/Vaccine): Not Related For weakness Causality as per reporter (Drug/Vaccine): Not Related For dizziness Causality as per reporter (Drug/Vaccine): Probable No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

Death I21.4 - Non-ST elevation (NSTEMI) myocardial infarction J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified

Within a couple of hours after receiving the vaccine, I broke out into a rash for 2-3 days, that was hot, red, and itchy. I had a mild headache in the back of my head with light sensitivity that also lasted 2-3 days. I went into A-fib with a heartbeat of up to 160 bpm. I was hospitalized for 6 days, on the 5th day the doctors performed a revision to get my heart back into rhythm and observed me for one more day.

I hurt like heck and I was in bed for a day, the day after dose 2, I went to my Cardiologist on 06/29/2021 and am now being treated for AFIB-he gave me Metoprlol-ER.

Patient hospitalized for Arthrosis of left acromioclavicular joint within 6 weeks of receiving COVID vaccination, then patient presented to the ED and hospitalized again for rapid atrial fibrillation.

Acute Ischemic stroke caused by blood clot.; Acute Ischemic stroke caused by blood clot.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-year-old non-pregnant female patient received bnt162b2 dose 2 via an unspecified route of administration, administered in Arm Right on 11Apr2021 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation at the age of 66-year-old. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 dose 1 administered in Arm Right on 21Mar2021 (Batch/Lot Number: EP6958) as single dose at the age of 66-year-old. On 27Jun2021, the patient experienced acute Ischemic stroke caused by blood clot. The event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the event and the patient was still under medical care. The event was reported as serious with seriousness criteria of life threatening. The outcome of the event was unknown. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination.

vaginal bleeding after approximately 12 years post menopause; abdominal pain; severe headache; neck pain; Periodic heart rate increase.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 66-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0179, Expiration date: unknown) via an unspecified route of administration, administered in right arm on 05May2021 at 15:30 pm (age at vaccination was 66 years) as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism, atrial flutter, ablation surgery and menopause (age 51). Concomitant medications the patient received within 2 weeks of vaccination included thyroid (ARMOUR THYROID) and acetylsalicylic acid (ASPIRIN) both taken for an unspecified indication. The patient previously took amoxicillin, codeine and nizoral for allergy. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. 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. On 06May2021, the day after injection, the patient experienced severe headache and neck pain for several days. On an unspecified date in June2021, the patient experienced abdominal pain and vaginal bleeding after approximately 12 years post-menopausal no bleeding. On an unspecified date in 2021, the patient experienced periodic heart rate increase. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient received treatment with Tylenol for neck and headache. The patient underwent lab tests which included pap test and biopsy with unknown results on an unspecified date. Since the vaccination, the patient has tested for COVID-19. The patient underwent lab tests which included SARS CoV-2 test (other): negative on 24May2021. The outcome of the events severe headache and neck pain was not resolved. The outcome of the other events was unknown. Follow-up attempts are completed. No further information is expected. Follow-up (16Jul2021): Follow-up attempts are completed. No further information is expected.

Brain swelling. July 24 breathing stopped for 2 minutes causing irreversible brain damage and brain death, body is still alive for to CPR.

A week after the first dose, I started to have a pain in the distal part of the tongue, at this time I thought it was just a beginning of a canker sore, gradually I feel a small painful blue mass. I went to see a Dr. he suggested a surgery. I consulted an ENT doctor who concluded for surgery to target a histological type of the tongue lesion. The surgery takes place on June 09 2021.The histological study showed a lesion embedded in a streaked muscular tissue, it is a partly thrombosed vascular lesion with endothelial capillaries. Conclusion: This lesion of cystic appearance embedded in the lingual muscle corresponds to an organized thrombus.

7:07 Started coughing then became nauseated proceeded to vomit. Nurse suggest after about 10 mins that she should take me to ED for Zofran. Upon getting to ED I was wheezing badly and trying to find inhaler in purse; wheezing and unable to catch a breath I was placed in a room, by then my body was turning red and wheezing worse. I was given epinephrine and prednisone immediately for anaphylaxis. They reacted immediately upon my arrival. Time I unsure. I just say thank God for them. Meds Given- Tylenol Duoneb, Decadron, Benadryl, Epinephrine, Pepcid, Nss

On day three after vaccine administration patient expired. quite an active man, no signs led up to his death until maybe a half hour prior to the event.

increased cough, difficulty breathing, anaphylaxis; received IM EpiPen, IM Benadryl, and IV Solumedrol 125mg Symptoms improved; did not need repeat Epi dosing. did not receive Famotidine because has documented allergy to Ranitidine.

"Pfizer-BioNTech COVID-19 Vaccine EUA" Patient was discovered deceased this morning by her family members.

Sometime in the week following the administration of the vaccine I developed two unprovoked DVTs and one SVT in my left leg and one unprovoked SVT in my right leg.

Five days after the vaccine she was on the phone, sitting in a chair and she lifted her arm up and it felt heavy and it just dropped. She then started to raise the arm and she was not able to do it. She then suddenly lost sensation in her left arm. She then could not control it, would raise when it wanted to but was not able to feel it or control it. (had the feeling that it was not connected to her body and it was just floating around). Then started having involuntary muscle spasms in her mid torso region. The same thing then happened again and the muscle spasms were more intense and she waited around and lasted for minutes. She never lost consciousness, but then it happened again and was spreading on her left side. It then encompassed from her hip up to her shoulder. The involuntary muscle spasms were moving from the side toward her chest to where she felt it would impact her breathing. She then went to the ER and they started doing testing, and she had more spasms, and then started having double vision. In talking with the doctor about all of this she had a CVA with complex partial epilepsy with recurrent seizures and that the double vision was related to the infarct in her brain and that the stroke triggered the seizure that she had. She did not lose any memory, loss of consciousness, no weakness or loss of sensation. These episodes only lasted minutes and a refractory time of minutes and when she got to the ER she the other episode when they were trying to test her. They were not able to do the EKG or EEG due to the involuntary movements and these resolved. She is now completely recovered other than the fatigue with no residual. She saw a neurologist on 2/24/21 who felt like that she had a stroke and put her on Keppra and is going to FU in 3 months at IU. It was ruled out that there was no relationship of her transplant to this reaction. She is now on Keppra, Atorvastatin for the swelling in her brain, and also put on aspirin 81 mg. Her blood tests that were done were all drawn and were all within normal limits except for kidney function, but is only a minor #'s for her secondary to the transplant. She then had some titers drawn for CMV and that was also negative. Then she had a COVID test that was negative. Then she had spinal tap that came back normal results.

67 year old female with PMH of HTN, HFpEF, history of DVT, obesity, migraines, gastroparesis, Sicca symptoms, asthma, chronic bronchitis, and GERD who presents with anaphylactic reaction s/p COVID vaccine administration. Received COVID vaccine across the street (<1 minute EMS ride) C/o itching, cough, and wheezing shortly after No respiratory distress or hypoxia en route Received IM epi (2 weeks expired) and Benadryl PTA Symptoms improving now Has extensive allergy list Review of Systems 10 point ROS completed and negative except noted in HPI above Physical Exam/Objective Vitals & Measurements last 24 hours VITAL SIGNS Temp C: 36.3 DegC Heart Rate: 87 bpm Resp Rate: 16 br/min BP #1: 139 / 59 mmHg SpO2 (%): 99 % O2 Device: Room air Height CM: 152.4 cm Ideal Body Weight: 45.5 kg General: NAD, well-nourished Eyes: No scleral icterus, EOMI HENT: Normocephalic, atraumatic, no airway edema Neck: Supple, intact range of motion Respiratory: Lungs CTAB, symmetric chest wall expansion, no wheezes, speaking in full sentences Cardiovascular: RRR, no murmur, +2 peripheral pulses Abdomen: Soft, NTTP, non-distended Musculoskeletal: No gross deformity Integumentary: Intact, warm, dry, no rashes Neurologic: A&O x 3, no focal deficits Psychiatric: Cooperative, appropriate mood and affect Medical Decision Making 67 year old female with extensive PMH including asthma, chronic bronchitis, and GERD who presents with anaphylactic reaction s/p COVID vaccine administration. Has long list of allergies. On exam, airway intact, no respiratory distress, no wheezing, speaking in full sentences, C/o subjective itching and cough that is starting back up. IV methylprednisone IV famotidine Albuterol PRN Benadryl PRN Observe Rx EpiPen upon discharge Re-Assessment Observed for >4 hours Symptoms resolved Counseled patient on EpiPen use and gave strict return precautions Has albuterol and Benadryl in her purse Has had many reactions in the past and is very familiar with how to manage them Discharge home with daughter

Patient was hospitalized with fever, body aches, inability to transfer and SIRS. Increased liver enzymes as well

I am writing this on behalf of my mother. She received the first round of the vaccine (Pfizer/EL9269) on 2/18/21. That evening she reported not feeling "right". Over the next two days after receiving the vaccine on Thursday she reported to family that she didnt feel well. She had no fever but muscle aches, an earache and sore throat (this was on Friday and Saturday). On Sunday her breathing became a bit labored. She still had previous symptoms reported and labored breathing -- she stated she thought she would have to go to the Dr the next day (Monday, Feb 22, 201) if she did not feel better. Sometime in the night of Feb 21st and Feb 22nd my mom passed away. My mom had many health problems. Heart disease, diabetic, she was on dialysis and had sleep apnea. However, she definitely seemed to be having some difficulty with the affects of the first vaccine. Please let her life be counted.

3 phases- within 24 hrs of shot - low grade fever and chills lasting 24 hours; during the following 2 weeks, strong pain in arm muscle that travelling under arm into lymph nodes. Approximately 30 days after injection experienced a mild heart attack and unexplained pericarditis. Symptoms at onset were major pressure in chest and elevated blood pressure 210/99. Prescribed blood pressure medication, blood thinners and 4 does of indomethacin for pericarditis

Extreme nausea; My symptoms were so severe I felt like I was going to die; I mean literally die; I thought I am going to have a stroke; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; Chills; Headache; The chest pain was horrible; The joint and muscle pain were so severe; I am still little real nauseous; I feel like I mean like acid coming up constantly making me more nauseous; Unable to eat; The joint and muscle pain were so severe; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; My chest is still tight; I still feel low congestion; having hard time taking a deep breath; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Deltoid Left on 19Mar2021 (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient previously had first dose of BNT162B2 for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication includes supplements and multivitamins. The patient stated "I wanted to ask you and I have some horrible concerns I got my second COVID shot last Friday, and by Saturday night, I am not exaggerating, my symptoms were so severe I felt like I was going to die I mean literally die on 20Mar2021. I couldn't get to emergency room, I figured out I am just going to die, I just laid down and let my door open down so somebody could find me, the symptoms I was having was extreme nausea, chills, headache, the chest pain was horrible, horrible, the headache I mean I thought I am going to have a stroke, the joint and muscle pain were so severe. So I have been taking Tylenol, Advil (Treatment) finally this morning, yesterday was tiny, tiny bit better, this morning its little bit better but I am still little real nauseous and I feel like I mean like acid coming up constantly making me more nauseous and almost like unable to eat. Ever since Saturday all I will have been doing is three bites of chicken soup three times a day. What in the world is going on with this vaccine that it would cause those severe symptoms and my chest is still tight I still feel low congestion having hard time taking a deep breath in Mar2021". The outcome of the event "my symptoms were so severe I felt like I was going to die I mean literally die" was recovered on unspecified date. The outcome of the event unable to eat was unknown. The outcome of the rest of the events was recovering. Information on lot/ batch number has been requested.

one bruise on the left arm, one bruise on the left knee, bleeding in labia area. Bruises were noticed 9 days after the shot. Bleeding happened 3 times during the first 12 days after the shot. No treatments. Assuming I got immune thrombocytopenia (ITP).

Patient presented 8 days after her vaccine with fevers and lethargy. She subsequently developed DVT, PE, and severe thrombocytopenia consistent with ITP. She has also developed encephalitis.

My wife had several blood clots in both lungs. She is now on blood thinners after spending 1 week in the hospital.

I had a return of a superficial thrombophlebitis on my left arm above where a catheter had been when I had surgery 7 weeks before. The blood clot returned again to the same level of pain and the same; I had a return of a superficial thrombophlebitis on my left arm above where a catheter had been when I had surgery 7 weeks before. The blood clot returned again to the same level of pain and the same; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 01Mar2021 13:30 (lot/batch number was not reported) as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure. The patient had no known allergies. The patient's concomitant medications were not reported. On 04Mar2021 07:30, the patient had a return of a superficial thrombophlebitis on her left arm above where a catheter had been when she had surgery 7 weeks before. The blood clot returned again to the same level of pain and the same. No treatment was received for the events. Patient was not pregnant at the time of vaccination. Patient had no COVID prior to vaccination and not tested for COVID post vaccination. Vaccine facility type was other. There was no other vaccine in four weeks and there was other medications in two weeks. The outcome of the events were not recovered. Information on the lot/batch number has been requested.

anaphylactic reaction; Throat swelling; heart racing; irregular heart rate; gasping for air; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6198) via an unspecified route of administration in Right buttocks, at the age of 67-year-old, on 08Mar2021 10:00 as SINGLE DOSE, for covid-19 immunisation. Medical history allergies: Sulfites, urinary tract disorder, Birth defect bladder w/ recurrent kidney stones, kidney infection, Grave's disease, and lyme disease. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination and was not tested post vaccination. Concomitant medications included levothyroxine and epinephrine. The patient previously took sulfur dioxide and experienced drug hypersensitivity. The patient experienced anaphylactic reaction with throat swelling, heart racing, irregular heart rate, gasping for air on 08Mar2021 10:45. Therapeutic measures taken in response to the events included self administration of epinephrine. The events were assessed as serious (life threatening). Outcome was recovering at the time of the report.

I was 2 weeks post prolapse surgery and healing quite well. I thought that would be enough time to wait to heal and get my vaccine. I got the vaccine in the afternoon and that night at about 10 pm I started bleeding profusely with blood clots coming out of my vagina. Before this I had no bleeding post surgery or any complications. This lasted all night. I went to the surgeon next day and the bleeding and blood clots had stopped. 2 days later it started again all night long. I refrained, stupidly, to not go to ER because of the virus. It stopped next day and then 2 days later I woke up in blood and clots and it would not stop. I had to go to the ER my surgeon said to stop it. He added more stitches to my previous surgery.

Patient stroke/CVA. Onsite EMS was called vitals 218/96 BG 164 HR 88 99% O2. Patient treated, transported to the hospital.

Hospital said: Acute allergic reaction, initial encounters, allergic reaction Anaphylaxis; swollen Vocal cords; loss of voice; bad cough; & headache Reaction Started 20 minutes after shot; cough was about 30 minutes later; headache started about 3 hours after shot

problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's been bothering her through the weekend/ left side weakness worsened; problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's been bothering her through the weekend/ left side weakness worsened; dragging her feet; trouble standing up; feels like a stroke in her leg; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown), intramuscular, administered in the left arm on 24Mar2021 at 12:30 as a single dose for COVID-19 immunization. Medical history included stroke on Dec2015 and Feb2016 and ongoing left side, having weakness since she had a stroke. The patient's mother had a really bad stroke on an unspecified date in her 80's. The patient's concomitant medications were not reported. The patient previously received the first dose of BNt162B2 (lot number: EN6208) on 03Mar2021 for COVID-19 immunization and had a sore right arm. It was reported that on 26Mar2021, the patient was dragging her feet and having trouble standing up. This occurred after her second shot. She has had a problem with her left side, having weakness since she had a stroke at the age 62 years. She worked through it and it was fine. But when she took the 2nd shot, it's been bothering her through the weekend. Her left side weakness worsened. She described the feeling like the stroke. Her doctor said when she gets sick, it could mimic her stroke symptoms. She added it is worse in the morning when she tries to get up. The patient added that her leg is affected, and feels like a stroke in her leg on Mar2021. She had no treatment for her experience and doesn't know if there is a treatment for what she is experiencing. The outcome of the events was unknown. Information on the lot/batch number has been requested.

My MOTHER had a health condition, diabetes and heart problems, she was at home with palliative care, due to her condition, she was fine in the last month she was able to walk, shower, eat alone, she felt happy to be able to recover, she got the vaccine because the doctor advised her, the same day she got fever, and began to feel fatigued, 3 days later my mother died, she had heart attack from shortness of breath.

entered room drooling . right sided neglect BP elevated . not following command send to ER Admited to hospital with CVA PCP Note upon return - Patient is a 67-year-old female with past medical history of hypertension, MS, dementia, CHF, chronic kidney disease and hyperlipidemia who was sent from the facility to the emergency room for altered mental status and possible CVA. In the emergency room, blood pressure was elevated at 170/100 and she was noted with more pronounced weakness in left upper extremity and lower extremity and left gaze. Neurosurgery was consulted and deemed patient a poor candidate for TPA due to recent GI bleed. Stroke workup was negative for acute findings and a brain MRI ×2 was negative. EEG was ordered to rule out seizure and it was normal and neurologist recommended to start patient on Keppra. Patient was initially started on aspirin which was stopped due to drop in H&H. Patient was also noted with low-grade fever and infectious workup including blood cultures, UA and extensive imaging did not have evidence of infection and COVID-19 was negative. Social services spoke to patient's sister who is the POA regarding advanced directives and she requested to change advanced directives to DNR/DNI/no PEG and orders noted in chart. Patient's symptoms progressively improved and discharged back to the facility and resting in bed comfortably in no acute distress

Hypoxia; cardiac arrest; This is a spontaneous report from a contactable physician. A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207), via intramuscular route of administration on 03Apr2021 at 15:15 (at the age of 67 years) at a single dose in the left arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Mar2021 (at the age of 67 years) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. On 05Apr2021, the patient experienced hypoxia and subsequent cardiac arrest. The events resulted in Emergency room/department or urgent care and hospitalization. The events were considered life threatening. Therapeutic measures were taken as a result of the events which included CPR and intubation. It was unknown if patient has been tested for COVID-19. The outcome of the events was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events hypoxia and cardiac arrest 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.

Stroke due to a large blood clot to the brain; Stroke due to a large blood clot to the brain; Widespread blood clots in both of her arms; This is a spontaneous report from a contactable consumer (daughter). A 67-year-old female patient received the 2nd single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, in the left arm, on 17Mar2021 (at the age of 67 years old, not pregnant at time of vaccination) (Lot number was unavailable since unable to locate or read the details), for COVID-19 immunisation. The patient's medical history included ongoing atrial fibrillation, high blood pressure, and scoliosis. Concomitant medications included ongoing acetylsalicylic acid (ASPIRIN) for atrial fibrillation, naproxen, pregabalin, tramadol, and metoprolol. The patient never had a history of blood clots. There were no allergies to report. The patient had not received any other vaccines in the four weeks prior to receiving BNT162b2. The patient had received the first single dose of BNT162b2 on an unspecified date, in the left arm. The patient's daughter stated that her mother suffered a stroke due to a large blood clot to the brain on 25Mar2021 at 12:30 am, requiring hospitalization. During hospitalization, a surgery to remove blood clot from the brain was needed. Hospitalzation lasted 12 days. The reporter added that in the week prior to the reporting, the mother 'passed' (as reported) but had widespread blood clots in both of her arms. The patient required unspecified treatment due to the events and had not recovered at the time of the reporting. The events were considered also serious since life threatening and due to disability. The patient did not have COVID-19 prior to the vaccination and had not tested positive post vaccination. Information on lot/batch number has been requested.

heart attack; stroke; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 24Jan2021 13:00 (at the age of 67-years-old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroid, sleep apnea, known allergies: Shellfish, Sulfa, Possible Tree Nut allergy. Concomitant medications included levothyroxine sodium (SYNTHROID); ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]); clarithromycin (CLARITIN [CLARITHROMYCIN]). In Feb2021, Exactly 3 weeks after the first dose, the patient had a heart attack and stroke. The events were assessed as serious (hospitalized, life-threatening, disability). The event resulted in emergency room and physician visit.The patient was hospitalized for 10 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The outcome of the events was unknown. Information about lot/batch number has been requested.

heart attack; stopped breathing; This is a spontaneous report from a contactable consumer. A 67-year-old female patient (mother) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 14Mar2021 (67-year-old) as single dose for COVID-19 immunization. Medical history included Hypothyroid, Sleep Apnea, Known allergies: Shellfish, Sulfa, Possible Tree Nut allergy. Patient is not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID); apixaban (ELIQUIS); senna [senna alexandrina]; valsartan; clopidogrel; metoprolol; atorvastatin; macrogol 3350 (MIRALAX). The patient previously took vitamins, Claritin , first dose of bnt162b2 on 24Jan2021 01:00 PM (67-year-old) for COVID-19 immunization and exactly 3 weeks after the first dose, the patient had a heart attack and stroke. Exactly 3 weeks after the second dose (04Apr2021), the patient stopped breathing and died. It was reported that death cause was unknown but also likely heart attack (unspecified date). Ae resulted in: [Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage, Patient died]. Number of days hospitalization is 10. Patient had no covid prior vaccination. The patient was covid tested post vaccination. The patient underwent lab tests and procedures which included covid test (Nasal Swab): negative on an unspecified date. The patient died on 04Apr2021. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: stopped breathing; death cause: likely heart attack

I had emergency surgery to remove a femoral blood clot from my groin to the bottom of my left leg; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 17Mar2021 12:00 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation at a Pharmacy or Drug Store. Medical history included known allergies to sulfa drugs, latex, animal dander, dairy, wheat, mold, mildew, ragweed and other wildflowers; and clot once before in the same leg-left inner thigh in 1974. Concomitant medications included thyroid (ARMOUR THYROID) and apixaban (ELIQUIS). The patient previously had a pneumonia vaccine on 24Feb2021 in the left arm. The patient does not know if her first dose of Pfizer vaccine caused this, but on "04Mar2010" (as reported) she had an emergency surgery to remove a femoral blood clot from her groin to the bottom of her left leg which started on 03Apr2021 at 12 AM (as reported). The event resulted in emergency room/department or urgent care visit, hospitalization for 2 days and was considered life threatening illness (immediate risk of death from the event). She had a clot once before in the same leg-left inner thigh in 1974. The patient was on Eliquis 5 mg 2 pills 2 X day for two more days, then 1 pill in am and 1 pill in evening for rest of her life. The patient had the second dose of BNT162B2 (lot: ER8732) on 07Apr2021 in the left arm. The patient has no covid prior vaccination and was not tested for covid post vaccination. The event recovered with lasting effects.

Patient admitted 4/17 after covid vaccination on 4/16. Was found to have elevated troponin on admission, hypokalemia, septic, elevated ALT, and hypotensive. Patient believed to have stroke on 4/19 and required intubation and transfer to ICU.

After receiving my second dose I was fine with a little pain at the injection site on 4/8 and 4/9. On Saturday, 4/10 I woke up feeling dizzy and my blood pressure was around 180/85. As the day progressed the dizziness turned to double vision and my blood pressure was 212/102. At about 3:30 PM I contacted my cardiologist who advised I go to the ER. Tests were run and they found that I had a Dorsal Pons stroke which caused the double vision due to lack of movement in my right eye.

Pt presented with abd pain, dark stool, altered mental status, febrile, hypotensive, septic, cardiogenic shock, progressed to multi organ dysfunction.

My mother was found deceased in her home two days after receiving the first dose of Pfizer vaccine of unknown causes.

blood clot; Right leg swelled and achy; Right leg swelled and achy; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EP7534),dose 1 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (at the age of 67years) as single dose for Covid-19 immunization. Medical history included ongoing Beta thalassemias. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated she has never had a problem with vaccinations, and she gets the flu vaccine every year. The patient reported that after the first injection coincidentally she did develop a blood clot in her lower leg. She thinks that it was due to a plane ride, but she has never had a blood clot before the injection. She added that she had the first dose on 16Mar2021 and developed a clot in a week. She further clarified that she got her first injection on 16Mar2021 and realized when she went on a flight, which is not that far she developed that clot and was having problems shortly after flight home on 24Mar2021 where her leg swelled up and she is on blood thinners since she went to the emergency room. She added that she developed the clot sometime between that flight and 02Apr2021. She had a doppler study on an unspecified date and it showed a blood clot. She stated that the outcome was she does not have the blood clot (as reported) but she will be on blood thinners and she needs to follow up on her scan to see if the clot issue is resolved but she will not have a doppler scan for another month or two and the blood thinner she is taking is Xarelto. She also stated that her right leg swelled up and it felt like a log. She reported it felt achy and swollen quite a bit from knee down and her leg was achy. It started between 24Mar2021 and by time she went to the emergency room she was not getting better. She had her symptoms for a week and toward the end of the week she thought she had a blood clot since it was not getting better it just got worse. She added that right now it is not swollen but she has been supine, and she does believe that it is better. The outcome of events was recovering. (As reported "outcome is unknown but pretty sure it has improved because of the blood thinners"./She stated she does not think it has resolved because it takes time for clots to resolve./She added that right now it is not swollen but she has been supine, and she does believe that it is better.) The reporter stated for the seriousness criteria for event blood clot: she believes as a nurse that any blood clot is extremely dangerous, and she was not hospitalized but obviously a blood clot is serious, and she could have ended up with pulmonary embolism. The seriousness for events right leg swelled and achy was reported as medically disabling. Causality assessment: Patient stated for the blood clot she has doubts if it was related to the vaccine but is it something that should be known about; for the leg swelling and achy she has doubts but it could have been the plane ride.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is unlikely related to the suspected drug. The plane ride may provide an explanation for the events. The case will be reassessed if additional information becomes available.

multiple er/admissions from february through april 27. pt deceased on 4/27/21 2/25/21 known past medical history of hypertension and hypothyroidism. Status-post spinal decompression due to stenosis. The patient then developed worsening issues with a surgical site infection. Patient has had numerous bouts of C diff. Staff notes patient is to have GI consult in the near future. Patient is seen today in her room. Patient was once again diagnosed with C diff and is currently being treated with antibiotics. Patient notes no bowel movements today. Patient has not had any issues with intake recently. The patient's weight has declined partially due to likely diarrhea. Patient's blood pressure continues to be monitored closely as it has been on the lower side of normal. Patient's potassium 2.9 on CMP. Patient's other care and therapies were reviewed. 2/28/21 Patient was admitted the hospital after found to be anemic at skilled care facility where she is being treated for C diff infection recurrent Lea. Patient was transfused. Patient was also found to have pneumonia/lung mass. Patient has struggled with electrolyte dysfunction. Patient had to be transfused a second time. Patient did well with second transfusion. Patient was found to be hypokalemic. Patient did well with potassium replacement. The patient was advised will have to do outpatient PET scan. Patient was found to have positive blood cultures as well 4/26/21 68 y.o. female who presents from nursing home with complaints of elevated white blood cell count. According to nursing home records patient had CBC checked on Saturday 04/24/2021 and her WBC count was found to be 50,000. At that point in time no other orders were given and patient was not sent in for evaluation. CBC was repeated this morning and WBC count found to be in the 70,000s. Patient was sent in for evaluation this morning. In talking with the patient, she denies any runny nose, sinus drainage or cough. Patient does report shortness of breath. Patient denies any chest pain or palpitations. Patient denies any dysuria, hematuria, fevers, or chills. Patient denies any nausea or vomiting. Patient does report diffuse pain across the lower abdomen. She does report chronic diarrhea. Patient had C diff stool checked on 04/13/2021 and was negative. (4/26 cdiff positive) Of note patient does have known lung mass that was seen on chest x-ray and PET scan. Patient reports that she does not want anything done and understands it could be cancer. And continuing to question patient, she reports she wants to be a DNR and does not want any aggressive measures.

ER report 3/16/21:patient is a 67 y.o. female who presents to the ED for evaluation of slurred speech. Onset of symptoms was last night with symptoms resolving within approximately a minute. Patient denies any associated numbness or weakness or blurred vision. Patient additionally states that she has been having increasing muscle spasms at night when laying down predominantly in her lower extremities. Clinical Impression 1. TIA (transient ischemic attack) 2. Hyponatremia 3. Hypokalemia

bleeding/bruising; CP (Cerebral palsy); itchy /itchiness; shaky; hot; Chest tightness; Anxiety; misc mental health; arm pain; bleeding/bruising; localized rash; SOB (Shortness of breath); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); NVD (Nausea, vomiting, and diarrhea); Visual/Neuro concerns; Visual/Neuro concerns; mechanical irritation; This is a spontaneous report from a non-contactable other HCP. A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EN6205) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. During her 15-minute waiting period after the injection, the patient began to experience itchy, shaky, hot, chest tightness. Patient monitored and improving. Patient ambulates well without dizziness. Chest tightness resolved and itchiness improving. Precautions discussed with patient. Patient aware of what to monitor and when to go to ED. Patient voiced understanding and appreciated. Patient able to ambulate out of the facility with ease. Vaccine-Related Anxiety (include misc mental health), Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) and Red flag symptoms (CP (Cerebral palsy), SOB (Shortness of breath), NVD (Nausea, vomiting, and diarrhea), Visual/Neuro concerns). Outcome of pruritus was recovering, chest discomfort was recovered on an unspecified date. Outcome of rest of the events was unknown No follow-up attempts are possible. No further information is expected.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. however, Relevant medical history and concurrent disease are missing for a medically meaningful assessment. 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.

A little over a week after the First vaccination, I developed two blood clots in my leg; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 via an unspecified route of administration, administered in the left arm on 18Mar2021 as SINGLE DOSE, for covid-19 immunization (at the age of 67 years-old). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 2 via an unspecified route of administration, administered in the left arm on 14Apr2021 as SINGLE DOSE. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Medical history included peripheral arterial occlusive disease from an unknown date and unknown if ongoing and bad circulation. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient developed two blood clots in her leg on 28Mar2021 a little over a week after the first vaccination. There was no treatment provided for the blood clots. The outcome of the blood clots was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Patient got second COVID vaccine on 4/1/21 Lot ER8737. On 4/2/21 she present to ED with R hip pain and was noted to have left lower extremity edema, ultrasound showed near occlusive DVT of L tibial vein. Time course of symptom onset unclear. Started on eliquis and continues to be monitored.

Patient had first Pfizer COVID vaccine on 1/28/2021. She had second Pfizer COVID vaccine on 2/16/2021.

transient ischemic attack; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration, administered in the left arm, on 30Jan2021 17:30, as single dose, for COVID-19 immunisation, at a hospital. Medical history included migraine and back pain. The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included ketoconazole and hydrocortisone (HYDROCORTISONE), all taken for unspecified indications, start and stop dates were not reported. The patient previously took codeine and sulfur dioxide and experienced allergies to both. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on an unspecified date, for COVID-19 immunisation. The patient did not receive any other vaccine in four weeks. On 19Feb2021 at 11:00, the patient experienced transient ischemic attack. This resulted to emergency room visit and hospitalization on an unspecified date. The patient was hospitalized for 1 day. Treatment for the event included unspecified blood thinners. The patient underwent COVID nasal swab on 19Feb2021 which resulted to negative, and an unspecified test on an unknown date with unknown result. The outcome of the event was recovered with sequel (reported as recovered with lasting effects). No follow-up attempts are possible. No further information expected.

ulcerated ankles bled into her shoe/ bled more; ulcerated ankles bled into her shoe/ bled more; bleeding disorder; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732), first dose via an unspecified route of administration, administered in Arm Right on 01Apr2021 (at 67 years old), single dose for covid-19 immunisation. Medical history included ongoing ulcerated ankles, joint bleeding diagnosed prior to the vaccine in her 40s. The patient had no concomitant medications. On 04Apr2021, 3 days post-vaccination her ulcerated ankles bled. She explained this bleeding has happened before, but she bled more, and it reached into her shoes which is "unusual". Patient came home from shopping three days after the vaccine and her shoes were saturated with blood, states this lasted for about a day and resolved two days later around 06Apr2021. She was reading through the paperwork and it said to let them know if you have a bleeding disorder. She is scared. Her ankles have bled like this before, wants to know if this is considered a bleeding disorder, does the vaccine make you bleed more. The outcome of the events was recovered on 06Apr2021.

stroking; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; this next am my blood pressure went up to 210/110 and HR 130 with a pounding headache.; This is a spontaneous report from a contactable nurse reporting for herself. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW01B1/expiration date: not provided), via an unspecified route of administration, on 19Apr2021 (at the age of 67 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history included ongoing hypertension (HTN) and COVID-19 on an unspecified date. The patient had known allergies to ciprofloxacin (CIPRO), latex and iodine. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included losartan. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Apr2021 at 12:00AM, the patient reported that after having her first vaccine on 19Apr2021, the next morning her blood pressure went up to 210/110 and HR 130 with a pounding headache and reported "thought I was stroking". The patient received treatment for these events which included extra medicine: an extra dose of losartan, clonopin and two acetaminophen (TYLENOL) and slept 24 hours. The outcome of the events blood pressure went up, heart rate increased, headache and "thought I was stroking" was recovering. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on chronological connection to the vaccine, a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) 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.

Lips started burning, tongue started, lost taste buds, throat drying/Basically an anaphylaxis but my throat did not close up; This is a spontaneous report received from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01May2021 11:15 (Batch/Lot Number: EW0172) (at the age of 67-year-old) as 2nd dose, single for covid-19 immunisation. Medical history included heart, hashimoto, high cholesterol, fibromyalgia and allergies. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); amitriptyline (MANUFACTURER UNKNOWN); carvedilol (MANUFACTURER UNKNOWN); clopidogrel (MANUFACTURER UNKNOWN); all taken (received within 2 weeks of vaccination) for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 administered in Arm Left on 10Apr2021 11:15 (Batch/Lot Number: EW0162) for covid-19 immunisation and had no adverse event. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01May2021 20:00, the patient lips started burning, tongue started, lost taste buds, throat drying. Basically, an anaphylaxis but my throat did not close up. The seriousness criteria were considered as non-serious. No treatment was given for the events. The outcome of the event was recovering.

Patient developed a severe headache about 30 minutes after vaccination and laid down to rest when she awoke she had leg weakness and went to the hospital for evaluation and was diagnosed with a ischemia cerebral vascular accident.

67-year-old female to the ED from home with complaints of worsening shortness of breath, fatigue, chest pain. Diagnosed with COVID-19 5/11. Admitted to inpatient for pneumonia due to COVID 19. She reports muscular chest pain when she coughs. Arrives with hypoxia, decreased breath sounds. Placed on 2LNC. D-dimer, CRP, ferritin elevated. CT chest shows: Diffuse bilateral COVID 19 pneumonia. Start on IV Remdesivir. Trend inflammatory markers. Has had symptoms for 8 days, so out of window for plasma.

left hand was edematous and cold; left hand was edematous and cold; left hand pain; blood clot; swollen submandibular gland that got bigger/could feel her mouth getting bigger; ill with something not related to the vaccine; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 03Mar2021 15:00 (Lot Number: EN6201) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included stroke on 2007, COVID-19 from an unknown date and unknown if ongoing. Concomitant medications included clopidogrel bisulfate (PLAVIX) taken for stroke from 2007 to an unspecified stop date; and acetylsalicylic acid (ASPIRIN (E.C.)) taken for stroke from 2007 to an unspecified stop date. The next day on 04Mar2021, the patient had a swollen submandibular gland that got bigger. She could feel her mouth getting bigger. The patient was admitted into the hospital on 07Mar2021 and released on 09Mar2021. She was readmitted to the hospital on 11Mar2021 until 18Mar2021. The patient went back into the hospital on 21Mar2021 and released 20Apr2021. The gland was removed on 13Apr2021. She developed a blood clot. She went to the emergency room and was sent home on Xarelto. The patient mentioned that she received the 1st dose of the vaccine on 03Mar2021 and came down ill with something not related to the vaccine. She was hospitalized for 4 weeks and ended up missing her 2nd dose appointment on 24/Mar/2021. She would like to get her 2nd dose but she is now 5 weeks overdue for it. She mentioned the hospital is recommending that she restart her vaccination. She is looking for guidance from Pfizer. The facility where the most recent COVID-19 vaccine was administered was in the hospital. 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. The patient underwent had CT and MRI of left arm/wrist which she does not have results to provide. Event relatedness to vaccine was unknown for events, swollen submandibular gland that got bigger, left hand was edematous and cold, left hand pain and blood clot. The outcome of the event blood clot swollen submandibular gland was recovered with sequel on unspecified date, the outcome of ill feeling was unknown and the outcome of the rest of the events was recovering.; Sender's Comments: The 67-year-old female patient had medical history of stroke. Based on information available, the reported thrombosis and other events were unlikely related to the vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE). This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

she had a stroke; ischemic stroke; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 11:00AM, as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included, allergic to bees and patient says there are members of her extended family that had strokes but they were almost 100 years old when they had them. her uncle died in October around Thanksgiving and he was 3 months shy of 100. She says they checked her heart and she was fine. Patient did not receive other vaccine in four weeks of vaccination. Concomitant medication's included levothyroxine sodium 50 mg once a day patient has been taking this for probably 5 years for inactive thyroid and General multivitamin for general health, patient says it is recommended by her general practice physician and she has been taking this for maybe 8 years, she guesses. Patient says she had an ischemic stroke 5 days after the second COVID vaccination. She says she is calling to see if there are any records of that happing to other people. She says she has to leave the call in 25 minutes. Patient says she had a stroke then went to the Emergency Room. For the outcome of the ischemic stroke she says there may be some things that she doesn't know. She says her doctor said she was ok and she can go back to what she was doing. Patient says the first shot says BioNTech and the second one just says Pfizer. She says the first one is a sticker and the second one is hand written. Second dose was on 15FEB2021, lot number EN6 then 2 or Z, she says she assumes it is a 2 based on the other lot number, then she thinks 01. For indication patient says she is all for the vaccinations, she thinks it's important to get the vaccine. She says she is the daughter of a physician. She says she is not scared of the vaccine, she believes in it. The patient previously received first dose of (BNT162B2), via an unspecified route of administration, administered in Arm Left, on 25Jan2021 11:00 PM (Batch/Lot Number: EL3247) as 1ST DOSE, SINGLE for covid-19 immunisation. On 19Feb2021 (probably late morning), the patient experienced ischemic stroke and on unspecified date of 2021 she had a stroke. The patient was hospitalized for the events from 19Feb2021 to 21Feb2021. The patient underwent lab tests and procedures which included echocardiogram: unknown, her echocardiogram was fine, magnetic resonance imaging: unknown and ultrasound scan: unknown on 2021. Outcome of the events was unknown. Follow up (PRD/SRD 04May2021): This is a Follow-up spontaneous report from a contactable consumer. Follow up(10May2021): This is a Spontaneous report from a Medical information Team. This consumer(patient) reported that: Follow-up attempts are completed. No further information is expected

Approximately nine hours after receiving my 1st dose, I had an anaphylactic attack. I immediately took 50 mg of Benadryl and adverted a full blown attack. I have had two attacks in the past for reasons unknown. One was approximately 21 years ago and the other was approximately eight years ago. Should I receive a second dose?

Shortly after the second vaccination I started developing frequent occular migraines. I had them occasionally before, but they became very frequent. I also had very bad pain in my wrists, which is one of my indications of inflammation. I had none of the regular advertse symptoms, like chills, fever, etc, so didn't associate with the vaccine. Less than one month after the second shot I experienced intense occular migraine (no pain), dizziness and nausea. Went to ER the next morning, and I had had a stroke. The neurologist says can't tell if due to migraine, but there is a rare type of stroke caused by occulat migraine.

Patient developed nausea/vomits, loss of taste and abdominal pain 6 days after dose 2 of Pfizer vaccine. Admitted after having had loss of consciousness and found to have acute liver injury on laboratory and peripheral blood lab values consistent with DIC and thrombocytopenia. Infectious workup negative, imaging studies were negative for ischemic etiologies. Patient had a new thrombus on imaging in the false lumen of a previously repaired aortic dissection. PF4 antibody assay was positive concerning for VITT. Treated with high dose steroids with stabilization of thrombocytopenia, improvement in liver function studies and improvement in clinical symptoms. Patient currently still hospitalized.

on 2/16/21 received second vaccine shot, one week later 2/23/21 had a stroke, fell out of bed, couldn't get off the floor, neice came at 8am and found me, called ambulance, ambulance took me to hospital, check by ER doctors, told i had a stroke; trouble speaking, conversating, speaking with others getting words out from brain to speak the words, have trouble gripping on left hand on a cup/glass, dropping things, have trouble on handwriting, writing is horrible

On Thursday, 3/18, I woke up at 3:30 am extremely dizzy with everything moving around me. Sitting up was better but upon laying down, the extreme dizziness returned. I was still dizzy when I finally fell back asleep. In the morning, I nearly passed out & was in a cold sweat when I got up. Gatorade helped. My PCP's office said it was probably a vaccine reaction. I continued to feel rather light headed & neck pressure & by Tuesday, 3/23, I had a lot of body aches, diarrhea, I was definitely light headed & felt like I could pass out. Over the next days, my blood pressure was very unstable. This random blood pressure issue continued & then the Premature Ventricular Contractions (PVC's) began to increase in spite of the Metropolol. They became very frequent causing light headedness & neck pressure. On 4/12, I went to the ER because my blood pressure was 185/50, heart rate 92. Every 3rd beat was a PVC. The cardiologist changed me to Verapamil 120 mg/day. My condition deteriorated especially in the 3 days prior to the ablation. I was short of breath with weak extremities. The ablation was done on 5/25 & the Cardiologist said I was having PVC's every 2 seconds. I am currently recovering from the procedure. Prior to the 2nd vaccine shot, my PVC's were well controlled by Metropolol to 18% from the 21% in February 2019 prior to taking Metropolol. My blood pressure was consistently normal as well.

Date of Admission 06/04/2021 Date of Discharge 06/05/2021 Reason for Hospitalization - Fatigue Hospital Course - Patient is a 67 YoF with a PMH significant for stage IV mantle cell lymphoma, antiphospholipid antibody syndrome on Xarelto, last received rituximab on 5/7 with recent hospital admission for Klebsiella pneumonia complicated with PCR positive rhinovirus and coronavirus not COVID-19 who presented as a direct admit from home for failure to thrive. She was seen in the ED on 6/1 for fever and generalized weakness. She was worked up in the emergency department with unremarkable CBC, CMP, noninfectious UA, and negative blood cultures. Chest x-ray with improving right-sided pneumonia. Possible early left-sided pneumonia. She was tested for covid 19 which was positive. Patient started on Levaquin and discharged home. She was seen in Heme/Onc clinic where she felt fatigued and continued to have occasional fevers. She called our office on 6/4 complaining of worsening condition, poor oral intake (reportedly no oral intake since Monday), and intractable nausea. Decision made to admit the patient for observation overnight. The patients lab work showed improvement of her infection from last time. Her CXR was clear compared to last time. The patient did have some nausea but was able to tolerate PO intake. Given this the patient was educated on Covid 19 and discharged home with a follow up with PCP within 7 days. Discharge Diagnoses Antiphospholipid syndrome COVID-19 CREST syndrome Decreased appetite Failure to thrive in adult GERD (gastroesophageal reflux disease) Mantle cell lymphoma Pain PNA (pneumonia)

Pericarditis with large bloody pericardial effusion and tamponade physiology. A life threatening event.

a little bit high LDL; little high HDL; mini stroke: facial droop, slurred speech, glossy eyes and a little out of it; mini stroke: facial droop, slurred speech, glossy eyes and a little out of it; mini stroke: facial droop, slurred speech, glossy eyes and a little out of it; mini stroke: facial droop, slurred speech, glossy eyes and a little out of it; mini stroke: facial droop, slurred speech, glossy eyes and a little out of it; This is a spontaneous report from a contactable nurse (patient). This 67-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in deltoid right (arm right; deltoid right; she thinks) on 31Mar2021 15:15 (Batch/Lot Number: EN6204) as 2nd dose, single at the age of 67-year-old for covid-19 immunisation. The patient historical vaccine includes received first dose of bnt162b2, via unspecified route of administration on 05Mar2021, 3:15 in the afternoon, in left arm, deltoid with Lot: EN6199 at the age of 67-year-old for COVID-19 immunisation. The patient medical history was not reported. Ongoing concomitant medications included citalopram; famotidine; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION), all taking probably 4 or 5 years. She took allergy medicine this time of year but was not on that during this time. No prior vaccinations (within 4 weeks). No family medical history relevant to events. No additional vaccines administered on same date of the Pfizer suspect. The patient experienced mini stroke: facial droop, slurred speech, glossy eyes and a little out of it on 09May2021 23:45. Patient states she is calling regarding the Pfizer Covid vaccine. Five weeks after the second vaccine, she had a mini stroke. She has no high risk factors. She is being tested currently for Atrial Fib and has a monitor. She had all of the testing done at the hospital. Had an MRI, CT scan on the carotids, and echocar-diogram and lab work. She had a little bit high LDL and that was the only thing that was abnormal, so they put her on baby aspirin and a statin drug. This happened when she was out of town. When she got back into town, her primary care physician said to report the mini stroke to Pfizer. There had been no reported side effects of clotting or whatever, with Pfizer. Before that, she had no high blood pressure, she doesn't smoke, and does not have diabetes. So, he said to report it. Called 911 and the ambulance came. They checked her blood pressure and blood sugar and they were pretty good. They advised her to go to the ER. Her son and husband drove her to the ER. She was in PRIVACY and went to PRIVACY hospital. They admitted her to the ER and gave her aspirin. She does not recall if it was one or two. She should have had 2 but does not recall. They observed her there. All of the symptoms resolved within 3 minutes. She had facial droop, slurred speech and glossy eyes. Her husband said she seemed a little out of it. They admitted her to the observation unit and they ran all the testing. Was there 13 hours. She was just in observation and was not admitted to the hospital. They needed her to follow up in a week with her physician. Has heard of other people having mini strokes but she is no expert. Just thought it would be nice if down the road, if there were any association, it would be published anytime that it did occur. No additional information provided regarding this statement regarding other people having mini strokes. Min stroke required a visit to emergency room and physician office. Relevant Tests: CT of carotids, MRI, echocardiogram, lab work, were all normal but little high HDL. They also did a separate CT of the carotids. They were going to do an ultrasound but did the CT of the Carotids. Event mini stroke: facial droop, slurred speech, glossy eyes and a little out of it seriousness reported as medically significant. Treatment for event mini stroke: facial droop, slurred speech, glossy eyes and a little out of it: nothing else at the time except the aspirin. They discharged her and told her she need-ed to take baby aspirin every day and atorvastatin, generic Lipitor, 40mg every day. Has been taking ever since. The outcome of event mini stroke: facial droop, slurred speech, glossy eyes and a little out of it was recovered on 09May2021.The outcome of other event was unknown. Causality reported as unknown. She would say that it is questionable. Is it a possibility? Yes but does not know.

Had thrombosis, Blood clots in leg; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (Lot Number: EN6198; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in arm left on 18Mar2021 at the age of 67-year-old as single dose for covid-19 immunisation. Medical history included diabetes. The patient's concomitant medications were not reported. Three days after vaccination, the patient had thrombosis, blood clots in her leg and had gone to the Emergency room on 21Mar2021. It started at night but she didn't know what it was, may be the same day she got vaccine (18Mar2021). The patient was taking "blood thinners" (medication name not clarified) for the Blood clots. The patient underwent lab tests and procedures which included ultrasound: unknown results on an unknown date. The outcome of event was unknown.

First adverse event was chest pressure/pain on June 7, 2021.Pericardial effusion and myocarditis diagnosed by echocardiogram on June 8,2021 Treatment ongoing with cholchicine for two weeks and follow up echo and dr appt in 4 weeks

sinus headaches; Her platelets are supposed to be 150,000 to 180,000, and hers are normally 120,000. Right now they are like 30,000.; Suspect ITP; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (BNT162B2), dose 2 administered in Arm Left on 26Feb2021 (Batch/Lot Number: EL9267) at age of 67-year-old as 2ND DOSE, SINGLE for covid-19 immunisation. Time the Vaccination Was Given Between 1100 and 1300. Vaccination Facility Type was Mass vaccination drive thru site. Medical history included she had a low platelet count before the vaccine, Seasonal allergies, Sinus headaches, diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. She doesn't remember what vaccines caused her to have a sore arm, maybe tetanus, but she doesn't remember. Her maternal grandmother had leukemia which is one of the possible causes. She never had anybody else in her family with ITP or anything like that. Concomitant medications included paracetamol (TYLENOL), ibuprofen, caffeine, paracetamol (EXCEDRIN), all taken for headache. She had both doses of the Pfizer covid 19 vaccine. The patient had her first dose of the Covid-19 Vaccine (lot: EL9269) on 05Feb2021 in her right arm and her second dose in her left arm on 26Feb2021. One of the reasons she got them in 2 different arms was because she heard she might be less likely to have arm pain. She doesn't remember what vaccines caused her to have a sore arm, maybe tetanus, but she doesn't remember. It has been years since she had another vaccine. She had enough that she actually wrote in her journal on 28Feb2021 that she was getting unusual black and blue marks all over and they were bigger than usual. It is possible it was immediately as soon as she had the second dose. She wrote on 28Feb2021, but she knows that is not the first day she noticed it. It is getting better. she still gets new ones that seem random. She has 2 marks right now on her trunk. She has one on her stomach and one on her side. She is still getting them but not as frequent or as bad. Some she knew where they were from, and others she had no recollection of hitting herself. She went to the doctor and had a regular physical and bloodwork done, and she is in the process of being diagnosed. They suspect ITP (Immune Thrombocytopenia Purpura). The AE require a visit to Physician Office. She gets seasonal allergies, and from time to time she gets sinus headaches. She thinks she might have had some headaches at that time. She assumed they were sinus headaches because it felt like they were. During the day she took 1 Excedrin and 1 Extra Strength Tylenol for the headaches. At night she sometimes took 2 Tylenol and sometimes Ibuprofen. She does remember having some headaches. Her headaches come and go. She had them she is thinking in February or March. She still has headaches. It is normal for her year round. She had quite a few more for a while, but now it is more normal like once a week. She takes the Excedrin, Extra Strength Tylenol, and Ibuprofen as needed. She tends to go with Excedrin and Tylenol for headaches during the day if she can. At night she tends to go with Tylenol unless she took it too close to bedtime to be able to take it at night. The Tylenol is 500mg. The Excedrin is a mixture of 250mg Acetaminophen, 250mg Aspirin, and 65mg caffeine. When she took the Ibuprofen she usually took 600mg. She did have bloodwork done. Her platelets are supposed to be 150,000 to 180,000, and hers are normally 120,000. Right now they are like 30,000. They said if she notices anything weird to go to the ER. She has had several platelet tests done. The first was on 04May2021, and her platelets were 30,000. The second was on 11May2021, and her platelets were 30,000. She had it done again on 17May2021, and her platelets were 25,000. Last week she had a bone marrow scan, and she will need a bone marrow biopsy. She did have a bone marrow biopsy done at a surgery center, but no treatment. It was to rule out other possible causes. The outcome of sinus headaches was recovering, of other events was unknown.

Nausea, vomiting, diarrhea, muscle pain with fatigue with the first and second dose. Was reported to not be able to hold anything down with second dose and sudden death while sleeping (nap for fatigue). Found dead in bed 3/21/2021. No allergic reactions were reported. No unusual electrolyte findings suggested the cause.

N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia D69.6 - Thrombocytopenia, unspecified

Blood clots both lungs; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: not reported) via an unspecified route of administration, administered in right arm on 30Mar2021 12:00, as DOSE 2, SINGLE for COVID-19 immunisation in pharmacy. Medical history included sulphate drugs allergy. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: not reported), administered in right arm on 09Mar2021 02:00, as DOSE 1, SINGLE for COVID-19 immunisation. On 22Jun2021, the patient had blood clots both lungs. The event reported as serious. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care hospitalization. Therapeutic measures were taken as a result of blood clots both lungs and treatment with heparin. Outcome of the event was not resolved. Information about lot/batch number has been requested.

Approximately 24 hours after receiving the first dose of the COVID vaccine, patient fell ill with extreme tiredness, profuse vomiting and loss of consciousness. Patient never regained consciousness, pronounced brain dead after AVM rupture and died on 3/8/21.

NSTEMI during dialysis session 7/19, patient has a history of previous NSTEMI 2019, dose of COVID vaccine given 7/16, Patient transferred to hospital ED

Concern comes from a pulmonary Embolism and DVT diagnosed within a week of the first shot. Realize this could be a coincidence, I have no history of clots.

Starting having Chest Pain and SOB on 2/5/21. Had oxygen saturation of 85%. Went to ICC and then ER on 2/8/21 for these symptoms.

6 hour run of AFib. I am a physician. I did not go to the hospital but had an irregularly irregular pulse with light headedness, mild shortness of breath, and after spontaneous conversion felt tired.

arm soreness; community acquired pneumonia; COPD; shortness of breath; chest congestion; weakness; fatigue; Muscle aches and pains; she became ill; This is a spontaneous report from a contactable nurse from a Pfizer-sponsored program Pfizer First Connect. A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular on 06Jan2021 at single dose on right deltoid for covid-19 immunisation. Medical history included blood pressure high and seasonal allergies. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Lot: EJ1685) on 16Dec2020 for COVID-19 immunization. The patient experienced community acquired pneumonia, shortness of breath, chest congestion, weakness, fatigue, COPD, muscle aches and pains, she became ill, all on12Jan2021; arm soreness on an unspecified date. Events required Emergency Room visit. Clinical course reported as: she got the second dose of the pfizer covid vaccine on 06Jan2021 and on 12Jan2021 she experienced shortness of breath, chest congestion, weakness and fatigue. Nurse stated ER doctor thought she had COPD or community acquired pneumonia. Nurse further stated she had the second COVID-19 vaccine on 06Jan2021. A week later on 12Jan2021, she became ill. She had all the symptoms of COVID. She was short of breath, very fatigued. She couldn't get any air, she was at work. She had muscle aches and pains. The shortness of breath, fatigue and weakness lasted several days. She also had severe chest congestion. She confirmed she got better. It actually took 4 or 5 days. By that Sunday (17Jan2021) she was better. She wanted it noted she had no reaction right after the shot. She stated she only had arm soreness, it was just a little sore, not even worth mentioning. It was only when she moved her arm a certain way. This was with either vaccine (first or second vaccine). She went to the doctor and somebody thought it might be a reaction, but the nurse thought it was too late for a reaction. The ER doctor thought it was COPD and community acquired pneumonia. Her primary doctor thought it was COPD. The patient underwent lab tests and procedures which included COVID-19 test: negative on 12Jan2021. Outcome of arm soreness was unknown, others was recovering.; Sender's Comments: Based on the drug-event time interval and the vaccine's safety profile, the community acquired pneumonia is possibly intercurrent condition, unrelated to vaccine BNT162B2 administration, which is not the disease that the vaccine BNT162B2 can prevent from. While the COPD is more likely underlying condition, unrelated to vaccine BNT162 injection. 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 bilateral Pulmonary emboli; pulmonary hypertension; short of breath; right heart strain; This is a spontaneous report from a contactable nurse. A 68-year-old female patient received first dose bnt162b2 (PFIZER COVID 19 VACCINE, lot number=EH9899), via an unspecified route of administration at right arm on 22Dec2020 08:00 AM at single dose for COVID-19 immunisation. Medical history included uveitis, arthritis and known allergies: pine nuts. The patient did not have COVID prior vaccination. The patient did not test for COVID post vaccination. The patient was not pregnant. Concomitant medication included prednisone (eye gtt), naproxen as needed (PRN) less than weekly. The patient previously took theophylline and experienced allergies. The day after getting the first dose of vaccine the patient worked all day in another (clinic withheld). She felt well all day, but at 6 pm when she left to go to her car she was so short of breath she had to stop twice to get there. Subsequent work up has shown that she had multiple bilateral Pulmonary emboli resulting in pulmonary hypertension and right heart strain. Adverse event start date was 23Dec2020. Adverse event start time was 06:00 PM. The adverse events resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 1 day, Life threatening illness (immediate risk of death from the event)]. Therapeutic measures were taken as a result of the events included Lovenox and Eliquis. The outcome of the event was recovering.; Sender's Comments: Based on available information and known drug profile the reported events are unlikely related to bnt162b2 . These are probably intercurrent medical condition. Case will be reassessed if additional information is received. 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.

Clinic course: 13:50 patient given covid vaccine #2-Pfizer. 14:10 patient c/o sob and throat closing. 02 sat 94%. Epipen 0.15 mg given IM to lt thigh. 02 at 4l/nc started. 14;15 EMS called to transport patient to UTMB ER. Bp-150/88, p-75. O2 sAT 98% ON O2@4L/NC. Patient Has audible wheezing and unable to talk above slight whisper. 14:20 Patient feeling a little better. Talking in a louder whisper now. Denies sob. States throat still feels like throat is opening a little. 02Sat 98% on 02 at 4l/nc. Patient was evaluated by NP- Employee Health. 14: 25- patient feeling better. I asked her if she has ever had a reaction needing epi pen before and she stated yes. For allergy shot. I asked her if she told MA when asked and she stated no as I didn't think I would be able to get covid vaccine if I said anything about it. She states no reaction to 1st covid vaccine. ED Course: is a 68 year old female with CAD s/p PCI, HLD, OSA, seizures, HTN, asthma who presents after anaphylaxis following 2nd dose of COVID-19 vaccine. Chest tightness and original EKG concerning for STEMI, but on review EKG was artifact and did not evolve. Normal sinus the following day with resolution of symptoms. Epipen also improved symptoms which would be inconsistent with ischemia. Patient respiratory status improved on prednisone and breathing treatments. Patient is now stable for discharge.

Fever, fatigue, runny nose the day after the 1st dose. . Pt deceased from COVID less than one month after 1st dose of vaccine

Patient hospitalized on 3/9/21 with one week history of fever, chills, and shortness of breath. Tested positive for COVID-19. Respiratory status worsened on 3/11 requiring transfer to ICU and intubation. Currently intubated in ICU.

4 days after I had the 1st shot I had an optic nerve stroke in my right eye with complete and permanent vision loss

she was so tired; Rash on both arms and inside arms/Rash on Face/rash on front and back of knees; burning and itching with bleeding; swelling in lips; Blood in stool/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Blood leaking around rectum/she had blood in her stool, leaking blood around rectum and it had like a burning itch; Face and Neck Burning/hot face and neck was flushed; hot face and neck was flushed; Tingling in tongue, lips, face; Tingling in tongue, lips, face; throat felt tight; lips were puffy; thought she was starting to shake; anaphylactic event; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 68-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), via an unspecified route of administration in left arm (left shoulder area) on 06Mar2021 17:45 at SINGLE DOSE for COVID-19 immunisation. The patient had no additional vaccines administered on same date of the Pfizer vaccine. The patient had no prior vaccination within 4 weeks. Medical history included upset stomach after eating banana's last year (2020). There were no concomitant medications. The patient had no family medical history relevant to events. The patient previously took bactrim and pneumonia vaccine and experienced anaphylactic reaction to both. On 06Mar2021, the patient experienced anaphylactic event, allergic reaction, face and neck burning, hot face and neck was flushed, tingling in tongue, lips, face, swelling lips, throat felt tight, and lips were puffy. On 07Mar2021, the patient experienced rash, blood in stool, blood leaking around rectum, burning and itching with bleeding. The patient further reported that she had a 'serious life threatening event' after first dose of the Pfizer Covid 19 vaccine on 06Mar2021. Hospital papers say 'anaphylactic event.' Tingling in lips tongue and face, hot face and neck after vaccine, swelling in lips, rash started yesterday evening (07Mar2021), bloody stools for a few hours yesterday evening (07Mar2021) but has resolved. The patient was seen in emergency room (ER) via ambulance. The patient asked if there was a chance the preservative in the vaccine caused her reaction and if the potassium in the vaccine causing her anaphylactic reaction. Additionally, the patient reported that she had a severe allergic reaction this past Saturday to the Covid Vaccine, stated the nurse sent her back to the pharmacist who told her she was having an allergic reaction to the vaccine. The patient reported having a hot face and neck was flushed, after the vaccine, she stated she had tingling in her tongue, lips, and face. And she stated her throat felt tight also, her lips were puffy, and a lot of heat of neck and face, thought she was starting to shake. The patient reported the pharmacist gave EpiPen in thigh and 20 mg tablet of Benadryl and called 911, and took her to the local hospital. Patient also reported that she has not seen this doctor yet she asked to see her and has an appointment with her. The patient also stated that her new PCP was not aware of the reaction to the vaccine at this time. The patient further mentioned that she was still having a rash that broke out. She reported that her tongue was tingling and she still has some swelling in her lips. Patient continues to clarify she still has swelling and some tingling on the tip of tongue and half back on her tongue. She stated that the swelling was persisting and that Benadryl or Prednisone does give some relief but it comes back. Patient mentioned being on a 4 day cycle of Prednisone, takes two in the morning with food. The patient clarified the location of the rash as a rash on both arms that was inside of both of the arms, like a pink rash, she states it was on face and on knees around the front and back of her knees like a red rash. She continues it was on the neck down to the collar bone around the back of her neck, like if she was a bust statue it would be all in that area from the collar bones at that point up and around the back of the shoulder blades. It goes all the way around face and neck. Patient also further reported that she had a scary reaction last night (07Mar2021), she said she had blood in her stool, leaking blood around rectum and it had like a burning itch, when she wiped it was blood, she continued to say when she wiped it was like 'giblets.' She stated was stool, blood, and giblets. Patient stated this lasted for about and hour and half or 2 hours until the stool stopped and it was about 1:30 am before she finally went to sleep, she was so tired on an unspecified date. She stated she took Benadryl right away. She continued to report the bleeding has resolved completely as of this point and reported a regular bowel movement today (08Mar2021). She has two Epi Pens from the drug store that was prescribed but she was afraid to use it, and she thought to see what happens if she uses the Benadryl. She received the Epi shot at the drug store, at (pharmacy), when her reaction broke out, on 06Mar2021, in her thigh, for the allergic reaction. This was her first time ever receiving EpiPen (Lot 029F20AA, expiration Mar2022, and NDC is 0093-5986-27). The ER doctor prescribed her 0.3 mg every 5-15 minutes as needed for anaphylaxis, and not to exceed 3 doses. She received the Benadryl at the drug store, 120mg tablet, first dose was given at drug store. Patient reported she was given prednisone IV in hand through IV at ER, she doesn't know how much that was, then was given Prednisone to go home with- 20mg tablets take 2 a day for 4 days, which she started Sunday morning, 07Mar2021. She was told she experienced a life threatening allergic reaction. Patient was taken to the ER in the ambulance, the paramedic who was with her said she was his first COVID reaction patient. ER doctor told her not to take the second dose of Pfizer vaccine, and to be cautious if taking the EpiPen, she states her heart was racing because of the EpiPen and was told it was because she was not younger that her body did not handle the Epi like younger people do and was told she could have a heart attack from the EpiPen. She was scared because she was not covered fully, since she can't get the second shot of Pfizer, and she was afraid of the Epi Pen, so she was really in a tough spot. ER doctor stated she may be able to take the Johnson and Johnson vaccine, as the second, but she needs to talk to her Primary care about that. The ER doctor continued to tell her it would have to be a special case where she was in a hospital setting in case she has another serious reaction, she was concerned for not receiving the second dose because that means she was not completely covered with one vaccine. She was afraid of the Epi-Pen since she can get a heart attack from it because of her age. The patient mentioned she was tested in Oct (clarified as 14Oct2020) for Covid due to having a viral infection at that time but was negative. Added the ER paper work says ED anaphylaxis. The patient wanted to ask about finding out the ingredients in Pfizer vaccine and the ingredients in the Johnson and Johnson vaccine. She saw the list on the fact sheet of Pfizer's ingredients and in a few places it says Potassium, 3 different ingredients, and several months ago, she quit eating bananas, bananas have potassium, and they were giving her stomach upset, diarrhea, she used to eat them all her life, she noticed that there was a lot of potassium in the medicine. Doctor wanted to know if she would be able to take the Johnson and Johnson vaccine. He said if she got the second shot, of the Johnson and Johnson, that it would have to be a special case, like in a hospital setting, and there would have to be medical people in a medical center, to take care of her was she has a reaction to it as well. He advised that she take the Johnson and Johnson than not taking it, because by not taking it, she was very vulnerable to catching COVID 19. And patient wanted to know was it a preservative that was causing the reaction. It was reported that rash began around 10PM, bloody stool began between 11 PM and 12:30 AM, all other symptoms within 15-20 minutes, it began around 6PM, maybe sooner 5:55 PM, she was in denial, it felt like tongue and lips tingling, she did have a reaction before to a different shot. The anaphylactic reaction required emergency room visit. Patient was not hospitalized and was in observation in ER. On 08Mar2021, the patient recovered from blood in stool, rectal bleeding, and burning and itching with bleeding. The patient had not yet recovered from severe allergic reaction, hot face and neck was flushed, tingling in tongue, lips, face; lips were puffy, and rash. The outcome of throat felt tight, thought she was starting to shake, she was so tired, and swelling in lips was unknown.

subarachnoid hemorrhages; This is a spontaneous report from a contactable consumer (patient self). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3248), via an unspecified route of administration (location: left arm) on 16Feb2021 at age of 68-year-old at single dose for COVID-19 immunisation. Medical history included polymyalgia rheumatica. No known allergies. Facility type vaccine was pharmacy or drug store. No other vaccine received within four weeks. No COVID prior vaccination. Concomitant medications included alendronate sodium (FOSAMAX), prednisone, methotrexate and hydroxychloroquine. The patient experienced subarachnoid hemorrhages on 23Feb2021 and sent to emergency neurosurgery on the same day for 2 subarachnoid hemorrhages. The event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was admitted into neurosurgery on unknown date and received treatment (unspecified). The patient was hospitalized for 9 days. COVID test (nasal swab) post vaccination on 23Feb2021 resulted negative. The outcome of event was recovering.

multiple blood clots in lungs; multiple blood clots in legs; feeling chest pain; short of breath; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), via an unspecified route of administration in left arm on 06Feb2021 at 18:00 at single dose for covid-19 immunisation. The relevant medical history included DCIS Breast cancer from 2016, Known allergies: pencillin from an unspecified date. Concomitant medications included levothyroxine sodium (SYNTHROID). The patient previously received first dose of BNT162B2 on 16Jan2021 at the age of 68 years old (lot number: EL3249, at 06:15 PM, in Left arm) for covid-19 immunisation. The patient received 2nd Pfizer vaccine dose on Sat, 06Feb2021. On Wednesday 10Feb2021 she became short of breath. On 11Feb2021, she began feeling chest pain. On 12Feb2021, she was advised by primary care Dr to go to the emergency room. She was admitted on 12Feb2021 to ICU with multiple blood clots in her lungs and legs. She was told by the emergency Dr this was a sign of Covid, they did a Covid test, came back negative. She remained in the hospital till 18Feb2021. She was at the time of the report on Eliquis (10 mg/d). A hereditary blood clot test was done that came back negative. She had never had an issue before the vaccination with blood clots nor anyone in her family and she was in good health before the vaccination. Dr didn't think the vaccine caused the blood clots but her primary care Dr thought it did-which was why she was reporting it. The patient also stated that event multiple blood clots in her lungs and legs resulted in Emergency room/department or urgent care, Hospitalization and Life threatening illness. The patient had hospitalization for 7 days. Treatment Heparin 25,000unit in .45% NaCl Premix, Narcan received. No covid prior vaccination. The patient underwent lab test included Nasal Swab which showed negative on 12Feb2021; Hereditary blood clot test which showed negative on an unspecified date in 2021. Therapeutic measures were taken as a result of all the events. The outcome of the events was recovered with sequel.

One week and one day after receiving this first vaccine, I had a 4 hour attack of AFIB. I have suffered from rhythm problems (diagnosed as throwing PVC beats) since going through radiation in 1994 for breast cancer treatment, but I have NEVER had anything like what I had in this attack. It was quite a coincidence that it occurred one week after receiving my vaccine. I have been having worsened issues with my arrhythmia ever since, worsened again by my second dose of vaccine.

Developed DVT blood clots in legs and clots in lungs.; Developed DVT blood clots in legs and clots in lungs.; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer reported that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN6198) on 06Mar2021 12:30 PM at left arm for COVID-19 immunisation. Medical history included known allergies: Clindamycin and high blood pressure. Historical vaccine was 1st dose of BNT162B2 (lot number EN6201) on 14Feb2021 01:15 PM at left arm for COVID-19 immunisation. Concomitant drugs included hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), omeprazole, nortriptyline hydrochloride (NORTRIPTYLIN). The patient developed DVT blood clots in legs and clots in lungs on 07Mar2021 08:00 AM. Event 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). Patient was hospitalized for 3 days and received treatment. The patient had computerised tomogram (CAT) scan, ultrasound, echocardiogram. Event outcome was not resolved.

sepsis; gallbladder attack; passed out from the gallbladder attack; Gets dizzy; Weakness; she was trying to gain her strength from being sick; her head hurt from the fall; her head hurt from the fall; she had to walk slower because she got dizzy; This is a spontaneous report from Pfizer. A 68-year-old female contactable consumer reporting for herself received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6200, expiry date Jun2021) on 16Feb2021 at 14:45, in left arm, for COVID-19 immunisation. The patient received the COVID-19 vaccine for age and several comorbidities. No other vaccines were administered within 4 weeks. Medical history included ongoing high blood pressure diagnosed 25 years ago, ongoing hypothyroidism diagnosed 25 years ago, liver resection in 2007 for a benign tumor (she had not been sick and it was found accidentally), liver bile duct stopped up from 2017 and ongoing (due to scar tissue from the liver resection surgery; she had an emergency stent placed in her bile duct), chronic Crohn's disease, ongoing thyroid disorder. The patient previously received flu vaccines on unspecified dates for immunization experiencing unspecified side effects some years ago, but this past year she didn't have a reaction. The patient previously received pneumonia shots on unspecified dates since few years. Family history included gallbladder problems in her sisters and mother. Concomitant medications included oral amlodipine (manufacturer: Lupin, expiry date: 23Feb2022) from an unspecified date (a few years ago) and ongoing, 5 mg at night, for blood pressure, oral telmisartan (MICARDIS; manufacturer: Alembic, expiry date: 02Mar2022) from an unspecified date (few years ago) and ongoing, 80 mg at night, for blood pressure, oral metoprolol (manufacturer: Mylan, expiry date: 09Feb2022), from an unspecified date (few years ago) and ongoing, 25 mg twice daily, morning and night, for blood pressure, oral levothyroxine sodium (SYNTHROID) from an unspecified date (20 years ago or more), 75 ug daily in morning, with water, hour before any eating or other medications, for thyroid disorder. The patient experienced sepsis on 25Feb2021 with outcome of recovered on 03Mar2021, gallbladder attack on 24Feb2021 with outcome of recovering, passed out from the gallbladder attack on an unspecified date in 2021 with outcome of unknown, got dizzy on an unspecified date in 2021 with outcome of not recovered, weakness from being hospitalized on an unspecified date in 2021 with outcome of not recovered, she was trying to gain her strength from being sick on an unspecified date in 2021 with outcome of unknown, her head hurt from the fall on an unspecified date with outcome of unknown. The patient was hospitalized for sepsis due to a gallbladder attack from 25Feb2021 to 03Mar2021. The events gallbladder attack and sepsis required also an ER visit. They did not require a physician office visit. Additional clinical course of the events included the following details. Gallbladder attack turned into infection/sepsis quickly. She previously had an emergency stent placed in her bile duct and now there was a stone in the bile duct and she was unsure if it was related; they will either remove her gallbladder or place a permanent stent. They removed stones and "goop" and placed a stent. Her gallbladder still needed to be operated on, but she was not sick with sepsis anymore. Regarding gallbladder attack the patient reported that it was controlled until further tests and surgery were performed. They couldn't do the surgery due to the infection which had cleared up but she did not want the surgery right now. A stent was placed in the duct until something was done and the stone will be crushed eventually. The patient passed out from the gallbladder attack. She never passed out, she had only ever passed out one other time in her 20's where she stood up too fast. The patient reported that she had to walk slower because she got dizzy and she was trying to adjust to getting home. She walked to the bathroom, used it, and her husband heard a thump while he was using the other bathroom. She was looking at the thermostat and fell in the den and she was surprised she didn't hit anything. Her head hurt from the fall. Sepsis: caller reported that as soon as she went to the ER, she was diagnosed with sepsis. Sepsis resolved the day she was discharged from hospital and when she was dismissed all tests were negative for sepsis. She went home on antibiotics for security for another week after discharge from hospital. Dizzy: it was just trying to get her strength up. She'll just be doing nothing and getting up too fast, it happened to any old person with blood pressure medicines. Dizziness began before she went into the hospital. She was experiencing weakness from being hospitalized and she was trying to gain her strength from being sick. Weakness began during her hospital admission and it was ongoing. On 03Mar2021 the patient underwent lab tests and procedures which included haematocrit: 30.4 %, haemoglobin: 10.4 g/dl (not in normal range yet), CMP: within normal limits (all results were within normal limits, including sodium and potassium), platelet count: 159, RBC count: 3.33 (supposed to be 3.9 or more but could have gotten better by now), WBC: 6.1 x10?/L, blood cultures: the results were not yet listed but sepsis was gone according to discharge blood work. She went to the doctor regularly. Her doctor knew how sensitive that was with her, but that her side effects were probably no more than anyone that experienced that. In some years she did not experience adverse events, specifically she did not with her flu vaccine in 2020. She has had side effects that had made her feel ill for 2-3 days and her niece was a nurse and thought she was making it up. The patient was advised to wait for the 2nd dose, she was unable to get it as scheduled on 08Mar2021. In meantime between receiving her first dose and her appointment for her second dose on 08Mar2021, she was hospitalized. The patient was just coming out of the hospital before 08Mar2021 and she still did not feel well so she cancelled the appointment. The hospital doctors, as well as the doctors approaching more tests with her gallbladder, recommended to not get the second dose as scheduled on 08Mar2021, but they could not recommend how or when to get it.

Patient died between late afternoon 3/9/21 and morning of 3/10/21. Found at a well-being check by police 3/10/21. Medical examiner declined autopsy.

3/6/21-About two in a half days following the 2nd dose, patient had sudden onset of right sided chest pain, pleuritic, lasted several days- did not seek attention. 3/17/21- Sudden onset of severe left sided pleuritic chest pain and dyspnea. Presented to ER, found to have extensive Bilateral Pulmonary Emboli. 3/17/21- Patient admitted to Hospital. Initially put on anticoagulation, but due to GI bleeding had placement of Inferior Vena Cava Filter. 3/23/21- Discharged from Hospital.

3.5 hours after receiving the vaccine, the patient was killed in a head-on collision. The patient was driving when her vehicle crossed the centerline and struck a second vehicle head on. It is unknown if the COVID19 vaccine contributed to the collision and death.

Covid Vaccine related ITP.......red pinpont rash on both legs, blood blisters on lips, tongue, gums and roof of mouth, blood streaks and bruises all over body, platelets dropped to 0 more than once. I was in Urgent Care, 2 ER's and hospitalized from March 14-24, 2021. I was given 84 bottles of immunoglobulin intravenously and high potency steroids (90 mg., 80 mg.). This did not bring my platelets up so our daughter contacted the wife of the physician who passed from this after his vaccine who in turn gave our daughter the name of another physician who had seen and treated this after the Covid vaccine. He,together with my physicians, came up with an aggressive treatment plan for me. I was given one Vincristine treatment and injections of Nplates to jumpstart my body. This had never before been seen where I was located, as the Covid vaccine is so new. I was a perfectly healthy woman who only took vitamins and had not even had a cold all winter. Everything else was ruled out.

second vaccine on 16Mar2021 and tested positive for covid on 21Mar2021.; Second vaccine on 16Mar2021 and tested positive for covid on 21Mar2021; pneumonia; This is a spontaneous report from a contactable consumer. A 68-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), and dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 (Batch/Lot Number: EN6202), both as a single dose for covid-19 immunization. The patient's medical history included blood pressure high and diabetes from an unknown date, and brain aneurysm from 2006. Patient has no family history. The patient's concomitant medications were not reported. On 21Mar2121, the patient experienced on the second vaccine on 16Mar2021 patient tested positive for covid on 21Mar2021. It was further reported that the patient took the 2 shots and the last shot was on 16Mar2021. In-between 16Mar2021 and 21Mar2021 the caller developed a cough (given Quercetin to take for it) and went to the urgent care on 21Mar2021. From the urgent care the patient was sent to the hospital and admitted because she was covid positive. Patient was admitted in the hospital from 21Mar2021 to 23Mar2021. The patient underwent lab tests and procedures which included chest x-ray: pneumonia on 21Mar2012 (pneumonia of left lower lobe due to infectious organisms). The outcome of the events was unknown

The patient developed shortness of breath with activity. The following day she spoke with me, her primary care provider, and I sent her to ER whereby she was found to have submassive pulmonary embolism.

On Monday April 12, my mother reported leg pain which she thought was related to a flare up of her knee (surgery 4 years ago). She described her pain as a strong sharp pain, that spread throughout her calf area. She reported it as increasing in pain and worsening daily. By Friday April 16th I asked her to report to Emergency Department. At which time she was told she had a blood clot in her right leg.

Client reported shortness of breath and chest pain 2 weeks after receiving second Pfizer COID vaccine. She was transported to the hospital and received an EKG and a CT Scan of the chest. Patient reported that the scan showed lareg blood clots in both lungs. She reports that she was given high dose TPA and admitted to the ICU. Per client she had ultrasound of legs, arms, and groin which was negative. She is currently taking Eliquis and was discharged from the hospital on 4/6/2021. #Hospital for 3 days

Acute pulmonary embolism; cardiac arrest; atrial fibrillation with rvr; pulmonary infiltrate right upper lobe; hyperglycemia; This is a spontaneous report from a contactable Nurse (patient herself). A 68-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 22Dec2020 11:45 (Batch/Lot Number: EH9899) as SINGLE DOSE for covid-19 immunisation at a hospital, at 68 years old. Patient is not pregnant. Medical history included hypothyroid from an unknown date. Patient has no COVID prior vaccination and has not tested for COVID post vaccination. Patient has no known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient experienced acute pulmonary embolism, cardiac arrest, atrial fibrillation with rvr, pulmonary infiltrate right upper lobe, hyperglycemia on 21Feb2021 05:00 which required Emergency room/department or urgent care. The patient was hospitalized (unspecified date) due to the events for 4 days. Therapeutic measures were taken included cardioversion twice and embolectomy. Outcome of the events was recovered with sequelae (with lasting effects) on an unspecified date. Seriousness criteria was hospitalization and life-threatening.; Sender's Comments: Based on the current available information, the reported events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. 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.

Received 2nd COVID vaccine on 4/19/21. Apparently hadn't been feeling well since. Presented to the ED on 4/21/21 with hypotension, bradycardia, hypoxia and a GCS of 3. Does have a history of ESRD on HD, but no missed dialysis sessions. Found to have a potassium of 8.7. There was concern for pulmonary embolism but was not hemodynamically stable enough to undergo imaging. Went into PEA arrest x 3 in the ED and ultimately died. Of note, patient did have a recent ankle fracture recently and apparently has been non-ambulatory for at least the past few days.

Patient found deceased at home 19 days after first dose of Pfizer vaccine. No reported side effects after vaccine. Patient did not have regular medical care. Autopsy performed due to lack of medical history and recent vaccination. Autopsy revealed marked pre-existing cardiac disease (hypertensive and atherosclerotic cardiovascular disease), which is the determined cause of death. Autopsy also revealed marked thyroid gland enlargement with Hashimoto thyroiditis diagnosed on histologic exam. It is unknown if this is pre-existing, as patient did not seek medical care and did not complain of symptomatology.

presented to clinic with complaints of R calf cramping for 15 days which had become acutely worse over the last week, especially bad when patient was walking. She has never experienced pain like this before. The R leg is also swollen from the calf down. She reports that sometimes the leg looks purple-ish and she endorses some tingling in the foot. Over the past couple weeks, she has also noted new dyspnea when walking. She denies fevers, chills, chest pain, palpitations, or cough. Of note, the patient had COVID-19 in November and since then has had some upper back pain which she currently has but it feels the same as usually does for her

stroke; R sided weakness; expressive aphagia; This is a spontaneous report from a contactable other health professional (patient). A non-pregnant 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm on 05Feb2021 (at age of 68 years old, no pregnant, Lot Number: EN5318) as single dose for covid-19 immunization. Medical history included type 1 diabetes, hypertension (HTN). The patient not had COVID prior vaccination also not had COVID tested post vaccination. No known allergies. Concomitant medication included insulin, lisinopril and Multi vitamin. The patient previously 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 15Jan2021 at 03:00 P.M. (at age of 68 years old, Batch/Lot number unknown) as single dose for covid-19 immunization. The patient received 2nd Covid shot on 05Feb2021. Had a stroke on 14Feb2021 at 08:00 AM with R sided weakness and expressive aphagia. Stroke noted on MRI in L hemisphere, speech area. The patient had no idea if this was related to the Pfizer Covid vaccine. AE resulted in: Emergency room/department or urgent care, Hospitalization (1 day), Life threatening illness (immediate risk of death from the event). Treatment received for events included observation, Lovenox. The outcome of the events was recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Stroke, Weakness left or right side, and Expressive aphasia cannot be totally 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 Committees and Investigators, as appropriate.

April 13, 2021 at approximately 9am I started passing blood clots, April 16,2021 blood clots stopped and I have not had any more. It felt as though I was having a period , except the blood clots were coming from my rectom.

Acute myocardial infarction LAD proximal, requiring thrombectomy. Unremarkable lipid profile, no other risk factors for CAD other than age.

Pt developed chest pain early am day following vaccine administration, presented to ED on 4/25 and was diagnosed with pulmonary emboli. She had recent muscle strain and chest/back pain that she attributed to lifting heavy objects the week prior to the vaccine (4/15), and had been mostly staying in bed or on the couch with minimal movement/activity 4/15-4/22 due to those symptoms.

had 3 ischemic strokes; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 27Feb2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included antiphospholipid syndrome from an unknown date and unknown if ongoing. Concomitant medication included rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported. On 19Mar2021, the patient was admitted to the hospital with stroke symptoms, it was determined that she had 3 ischemic strokes on 18Mar2021. The patient was hospitalized for the event from 19Mar2021 to an unknown date for 2 days. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 20Mar2021. Therapeutic measures were taken as a result of the event. The outcome of the event was recovered on an unspecified date. Information on the lot/batch number has been requested.

Anaphylactic shock; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 19Mar2021 11:00 (Batch/Lot Number: EN6204) as SINGLE DOSE for covid-19 immunisation; diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from 19Mar2021 (Batch/Lot number was not reported) to 19Mar2021, at 10 mL for an unspecified indication. Medical history included allergy to bees, hornets, all insects with a stinger and egg allergy; all ongoing. The patient's concomitant medications were not reported. The patient experienced anaphylactic shock within 10 minutes after her first dose on 19Mar2021. Patient took children's Benadryl 10 ml one hour before vaccination like ger doctor suggested but still went to anaphylactic shock. She ended up in the emergency room for 6 hours because her mouth still felt funny and they were waiting until she was breathing and swallowing better, and stated that for a week and a half up to two weeks afterward, she still had trouble breathing and swelling of mouth and throat. The clinic gave her a Benadryl shot when her reaction happened and the Emergency Room gave her one also. Emergency Room also gave her three other medications in her IV. She thinks the Benadryl shots she received were 25mg; but isn't sure. Patient was not admitted to the hospital. Outcome of the event was recovered on an unspecified date in 2021.

This 68 year old female received the Covid shot on 4/7/21 and died on 4/13/21 . 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.

This 68 year old female received the Pfizer Covid shot on 2/1/21 and went to the ED on 2/21/21 and was admitted on 2/21/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) R29.810 - Facial weakness

she feels like she has Covid; feeling chest pain/her chest is sore; headache/her head just starting hurting; she is scared; She used to weight 143 pounds 9 months ago, she states she is swelling up.; overall body aches; cramping; eyes had swollen; fever of 101.9°F/temperature like 101.9 degrees, a fever; chills; nausea; wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker.; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1, via an unspecified route of administration, administered in Arm Right on 12Apr2021 11:00 (Lot Number: EP7534; Expiration Date: 31Jul2021) as SINGLE DOSE (at the age of 68 years old) for covid-19 immunisation. Medical history included she is on the borderline of Chronic obstructive pulmonary disease (COPD). She was taking breathing medicine, but has been taken off of it, she is doing so well; osteoporosis; osteoarthritis; osteopenia. Concomitant medication included hydrocodone (HYDROCODONE) taken for osteoporosis, osteoarthritis, osteopenia, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On unspecified date the patient experienced feeling chest pain/her chest is sore, headache/her head just starting hurting, she is scared, she used to weight 143 pounds 9 months ago, she states she is swelling up and overall body aches. On 14 Apr2021, she experienced wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker. She wiped this morning, and she thinks it stopped. She felt cramping. It started light pink, then a couple days ago it was darker. She was a walk in patient at the clinic to be checked out. She lives alone, has no companion for a sex life, she had no new medications. She went to her physician yesterday 22Apr2021, and had a pap smear and blood draws. Her MD told her to take Airborne around the time of the second vaccine. On 16Apr2021 she experienced nausea. On 22Apr2021 the patient experienced eyes had swollen, fever of 101.9°F/temperature like 101.9 degrees, a fever, chills. On 23Apr2021 the patient experienced cramping.The headache has been on and off all weekend. She felt she was dying. The worst yesterday. She read all the Covid symptoms and all her symptoms point toward Covid. She feels like she has Covid from unknown date.She has chest pain and tries to ignore it, but she can't. She has to go get her pain pills because her head just starting hurting.The patient underwent lab tests and procedures which included body temperature: 101.9 degrees fahrenheit on 22Apr2021, blood test: unknown results on 22Apr2021, pap smear: unknown results on 22Apr2021, weight: 143 lbs on 9 months ago. Therapeutic measures were taken as a result of overall body aches. She took gas pain pills, allergy relief pain pills because her whole body hurt. She has been applying warm towels to her eyes to help with swelling. Outcome of fever of 101.9°F/temperature like 101.9 degrees, a fever, chills was recovered on 23Apr2021. Outcome of eyes had swollen, headache/her head just starting hurting, nausea, wiping would be pink/She also states that she when she went to the bathroom, she wiped pink and it worsened and turned darker was recovering. Outcome of feeling chest pain/her chest is sore was not recovered. Outcome of she feels like she has Covid, she is scared, cramping, he used to weight 143 pounds 9 months ago, she states she is swelling up, overall body aches were unknown.

Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction.

passing blood clots from her rectum; blood clots; deathly ill; the lymph nodes underneath the arm swell up / She swelled up on her right side; kind of in the breast/chest area, up a little higher than the breast and it was very uncomfortable; This is a spontaneous report received a contactable consumer, the patient. A 68-year-old elderly female received the first dose of intramuscular BNT162b2 (solution for injection; Lot ER8737 and expiry information not provided) as a single dose in the left arm on 08Apr2021 at 11:00 (at 68-years-old) for COVID-19 immunisation. Relevant medical history included ongoing back problems for which she takes medication. Concomitant medications included unspecified medication for back problems. The patient denied any other vaccines within four weeks prior to this vaccine. The patient reported that she generally gets the flu shot every year and has never had any adverse reactions. The patient also mentioned that she previously tramadol (for an unspecified indication) in the past but has not taken it for years. The patient reported that she received her first dose on 08Apr2021 at (Privacy). The patient explained that within six hours she was deathly ill. The patient reported that stayed very ill for quite a few days. The patient stated when she gets up in the morning, she gets up early and she always goes to the bathroom. The patient stated that on 13Apr2021, when she went to the bathroom, she started passing blood clots from her rectum which went on until 16Apr2021. When describing the blood clots, the patient stated 'envision sunny side up eggs, between six to eight of them, and in between that was all this webbing holding the clots together'. The patient stated while she was urinating, the clots were just pouring out of her rectum. The patient clarified that there was not blood in her stool. The patient explained that she took the opportunity to get some plastic gloves and look through her stool for blood and there was not any. The patient stated that her underwear and the toilet paper was stained. The patient also stated that she was reading that whichever arm you get the vaccine, the lymph nodes underneath the arm swell up. The patient explained that her lymph nodes did not swell up underneath her left arm where she got the shot. She swelled up on her right side. She clarifies she was swollen underneath her arm, kind of in the breast area and chest area, up a little higher than the breast. It was very uncomfortable. The patient denied any visits to the emergency room or doctor's office for the events. The outcome of the event passing blood clots from her rectum was recovered on 16Apr2021. The outcome of the events deathly ill, the lymph nodes underneath the arm swell up / She swelled up on her right side, and was very uncomfortable was unknown.

Shortness of breath, leg pain and swelling, generalized malaise, acute coronary syndrome, CHF, fever.

DVT to right popliteal vein; This is a spontaneous report from a contactable physician (patient). A 68-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly, administered in left arm, on 29Dec2020 (at the age of 68-years-old) at 1st dose, single for COVID-19 immunisation. Medical history included type II diabetes and hypertension. The patient was not pregnant. No COVID prior vaccination and no COVID tested post vaccination. The patient had no known allergies. Other medications in two weeks included metoprolol, ramipril and metformin. No other vaccines were received in four weeks. The patient experienced deep vein thrombosis (DVT) to right popliteal vein on 15Mar2021. The event resulted in doctor or other healthcare professional office/clinic visit. Treatments were administered as a result of the event and included ELIQUIS, bed rest, legs elevated. The patient was recovering from the event.; Sender's Comments: Based on the temporal relationship, the association between the event deep vein thrombosis with BNT162b2 can not be fully 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.

Bladder irritation two days after first shot. Some blood tinge. Resolved in a few days. Significant bladder pain, bleeding, incl clots two days after second shot. Resolved with cranberry pills after a few days. Thought maybe was due to eating jalapena peppers in my chicken nachoes. Both weekends. Then heard that women are reporting bizarre bleeding after vaccination so re evaluated and considered the bleeding could have been an adverse reaction to vaccine and decided to report my experience.

EMS dispactched to scene of home with CPR in progress. Pt. was in VTACH and shocked X1, Epinephine X 2, Bicarb X 1. Return of circulation which was lost enroute to ED. CPR started again. Blood/Frothy sputum noted from tube and mouth. pupils 3 mm, sluggish. mottled skin in exremities. Glasgow coma score of 3. In the ED Epi, bicarb, Ketalar, Lasix, CaCL, norepi Pt. transfered by helicopter to higher level of care,

Had headaches and felt nauseated; Had headaches and felt nauseated; Had a blood clot in her lungs; she had tripped and fallen; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN6206) via an unspecified route of administration on 16Apr2021 at 10:00 ("around 10:00 or so"; at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunisation (the patient was "fearful of the new variants and wanted to be extra protected against those variants.") Medical history included COVID in Dec2020 and uses oxygen (normally used oxygen, but not all the time), from an unspecified date and unspecified if ongoing. Medical history was also reported as none. Relevant family history related to the adverse event was reported as none. Concomitant medications (other products) were reported as none. The patient did not receive prior vaccinations, within 4 weeks prior, or on the same date as the COVID-19 vaccine. The patient previously received iodine contrast dye on an unspecified date for an unspecified indication and experienced anaphylactic shock. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN6207) via an unspecified route of administration on (at the age of 68-years-old) as a single dose in the left arm for COVID-19 immunisation and experienced did not feel well, felt achy and nauseated (captured in AER: 2021495492). On 27Apr2021 the patient experienced had a blood clot in her lungs and she had tripped and fallen and on unspecified dates the patient experienced had headaches and felt nauseated. The course of events was reported as follows: "After the second dose of the vaccine the patient felt fine, she felt pretty much okay. She attributed that to her having had COVID back in Dec2020 based on her biological knowledge. She ran this idea past a pharmacist that said that generally people might take the first dose of the COVID vaccine and be fine and then be worse on the second dose. But since she had COVID in Dec2020 her second dose of the COVID vaccine was the problem like how people's antibodies were already built up and had that reaction so that is why she was fine. She was walking out of the hospital on 27Apr2021, there were people that had crossed in front of them very quickly and her foot had hit the foot of a lady that was pushing a gurney. The patient tripped and fell down and she was taken to the emergency room. In the emergency room, a doctor did some tests and shockingly the doctor said that the patient had a blood clot in her lungs. A physician's assistant told the patient that she needed to have a computerized tomography (CT) scan done. The patient needed to go home to take care of responsibilities there, so she walked out of the hospital. She did not know if she had a blood clot in her lungs or not. Her doctor said that the blood clot in her lungs was based off of two blood values. One was the d-dimer that had a reference value of < 500 and her level was 1,079 and the other blood work was troponin-I but it looked like it should be in the normal range because her level was less than 0.03 and the reference range was 0-0.04, so she would think that she would fall into the normal range. The d-dimer one was kind of scary. She had other tests done. They did a regular complete blood count (CBC) on her, another kind of test and another set of blood values but from looking at the results she was only a little low on a couple of things. They did not do the test with the contrast, but they did take an x-ray of her lung. The technician had found out that she had not had a Computed axial tomography (CAT) scan in a while, since she apparently needed them periodically, and she felt uneasy because that technician was urging her to get a CAT scan. The patient she did not know if these results were relevant or from the COVID vaccine. She did not understand this but when she was looking at the lab notice there was a note that the patient should be monitored for B Type Natriuretic Peptide (b/np) levels. It had the reference range on that one but when she read it, it looked like hers lied within the normal range. After the second dose she just had a headache but did not feel sick, but a week later they were telling her that she had a possible blood clot in her lungs. The patient was concerned at this point because she had no reason as to why she would have a possible blood clot. When she gets exhausted her oxygen drops and sometimes it will without her being exhausted. She was scared to go back to that one hospital. She was thinking about going to another hospital that was 60 miles away. If they would need to keep her overnight, she would need to make arrangements for her animals. She has had headaches, but they may be due to stress. She did not feel sick, other than she had been nauseated. The patient stated that she was not saying that what was reported on report 1 of 2 was due to the Pfizer COVID vaccine but why would they say that she had a blood clot too." The clinical outcomes of the events had a blood clot in her lungs, she had tripped and fallen, had headaches, and felt nauseated were all unknown.

I thought I was having heart attack.; At midnight I woke up with severe chest pains.; Nausea; It was severe gas & cramping.; It was severe gas & cramping.; This is a spontaneous report from a non-contactable consumer (patient). A 68-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 15Mar2021 19:30 (Batch/Lot Number: 1621146-00) (at the age of 68 years old) as 1st dose, single for COVID-19 immunization. The patient had no other medical history and concomitant medications were not reported. The patient previously took polyethylene glycol and had known allergies to the medication. No other vaccine in four weeks. The shot given was at 19:30. At midnight (16Mar2021 12:00 AM), the patient woke up with severe chest pains. She thought she was having heart attack. It was severe gas (Gas in chest) and cramping. The patient had this almost daily for 2 weeks. She had nausea for one week. The patient reported that she never experienced this in her life and still happens at least once a week. There has been no change in her diet before or after the vaccination. Events usually will be relieved within 2 hours after taking GasX. No COVID prior vaccination and patient had not been tested for COVID post vaccination. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

On 05/05/2021 Pt received the Pfizer vaccine. The next day she got chills, headache, muscle aches. These symptoms lasted until 05/08/2021. "I was feeling much better and started working in my garden, suddenly I felt on my right calf, and I noticed a "big knot". Daughter of the patient took her to the ER on 05/08/2020, where she was scheduled to a diagnostic test on 05/12/2021. On May 12, pt also received the phone call of her PCP, who diagnosed her over the phone: "blood clot" and prescribed her with Xarelto (Rivaroxaban), a blood thinner. A doppler test was performed to the patient that day and a blood clot was found. On May 21 Pt had an appt with her PCP, and PCP advised to report this to the CHD. Pt currently walks with a cane. her next appt is with an Hematologist to find out for how long she will be taking blood thinners.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department three days after vaccination reporting five hours of left-sided weakness. Diagnosed with right pontine stroke, admitted to hospital, initiated anti-platelet and cholesterol-lowering medications, symptoms resolved, and patient discharged to home medically stable.

Stroke/in her head on her left side; Blockage in her head, there was a blood clot in her head; Arm doesn't work; All she could say was I cant/still needs speech therapy; Really bad headaches; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9269; Expiration date was not reported) on the left arm on 04Feb2021 (13:21) as a 2nd dose, single dose, with route of administration unspecified, for COVID-19 immunization at the public health department (not a military facility). The patient had a family history of five heart bypass surgeries (father); stroke (father); and stents (mother). There were no concomitant medications. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249; Expiration date was not reported) on 14Jan2021 (when the patient was 68 years old) for COVID-19 immunization, and had hypersensitivity, rash and cerebrovascular accident. On 07May2021, the patient had a stroke (in her head on the left side). The patient was hospitalized from 07May2021 to 10May2021 due to the stroke. In May2021, the patient had a blockage in her head/there was a blood clot in her head; her arm did not work; all she could say was "I can't", and still needed speech therapy; and had really bad headaches. The events had resulted into an emergency room visit. The patient had received clopidogrel (PLAVIX) as treatment for stroke and blockage in her head/there was a blood clot in her head; and duloxetine ACL as treatment for the really bad headaches. The outcome of the events was recovering for 'stroke' and 'all she could say was "I can't", and still needed speech therapy'; was not recovered for 'really bad headaches'; and was unknown for all the other events. Information on lot/batch number was available. Additional information has been requested.

Xgeva: bleeding on her hands; redness; Xgeva: rash on both hands; Xgeva: swelling on right hand; This is a spontaneous report from a contactable consumer. A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation; denosumab (XGEVA), via an unspecified route of administration from 07May2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. No other Products. No patient History. The patient medical history was not reported. There were no concomitant medications. The patient received first dose of BNT162B2 on an unspecified date for covid-19 immunization. Stated that patient started Xvega on 07May2021 and had a very bad rash on both hands, swelling on the top of her hands and swelling on right hand on 08May2021, and bleeding on the hands. 'Is going to the dermatology'. Stated that there was redness. Stated that patient had her second dose of the vaccine on that Wednesday the day before. Treatment included given Cortisone Cream for the rash. The outcome of rash on both hands, swelling on right hand was not recovered, of other events was unknown. Information about lot/batch number has been requested.

After 7 days after my 2nd dose I started to have arithma and papulations. I did not think anything of it for the first few days. I waited a few days and it happened again. I contacted my physician and they gave my a monitor to wear, they diagnosed it as atrial fibrillation. The doctor wanted to monitor it long term. I currently have a loop recorder in which they download the data everyday. I have not have any atrial fibrillation since there. I did not have any shortness of breath or I did not faint. They are going to repeat my EKG in a few months to make sure it doesn't show anything else.

heart attack; cardiac problems; inflammatory response; chest pain; fatigue; diarrhea almost every day since the shot, except 2 or 3 days; pain; stomach pain/had a stomach ache in the pit of my stomach like I had a virus; Pain in Ribs; pain in her shoulders; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206), via an intramuscular route on 08Mar2021 (at the age of 68-years) as 1st dose, single dose in the left arm for COVID-19 immunisation. The patient medical history included a list of allergies to various medications. She has a anaphylactic type reactions with contrast, iodine, and opiates, cardiac disorder, bladder infection, immune system problem, carcinoid tumour, severe pneumonia after being in contact with people from South America on Dec2019, experienced 104°F fever, vomit and GI tract infections, it was resolved after sleeping for 3 days and drinking liquids and irritable bowel, tubular adenoma. Concomitant medications were not reported. The patient previously took oral steroids, oral yeast infection medication, and tetracycline cause blisters all over to form. On unspecified date, the patient experienced diarrhoea, fatigue, chest pain, and pain in between ribs, Approximately 5 or 6 hours after vaccination she experienced pain in her stomach and ribs, this continued for up to 36 hours after vaccination, then, she experienced intermittent episodes of diarrhoea. Had also felt very tired, she did not wanted to went outside. Patient took BENADRYL for these symptoms. It was reported that patient had cardiac problems (did not mention the exact condition), after receiving the PFIZER-BIONTECH COVID-19 vaccine she felt pain in her shoulders, thought she was about to had a heart attacked. Due to her heart condition, many medications caused arrhythmias, she was unable to took muscle relaxers, pain medicines, or FLEXERIL. The patient had a history of immune problems (again, did not clarify what conditions), experiences frequent infections and had to used (unidentified) antibiotics, some antibiotics caused GI discomfort and infections. She was thinking that by the time the vaccine dna mixes with her dna. Asks for a resource where she could look up information. After having antibiotic-related as she ate yoghurt and ate a special diet of probiotics. She had a carcinoid tumour that doctors could've found. Patient wants to knew that she was having issues with her stomach and wants to knew how long would this went on. Got the shot on the 8th and it was been 3 weeks. Wants to knew if she could've took buttermilk since it puts the good bacteria backed into the stomach. Patient stated that irritable bowel that did not went away and researched this to helped herself and found foods to heal. She had a carcinoid tumour that they can't got to because she can't took contrast. They gave me contrast at 40 years old and it blew me up liked a blowfish. Patient started doing these shakes and about 6 weeks later, her diarrhoea quits but still had diarrhoea off and on. She bad reactions to antibiotics all the time since it gives me diarrhoea. The stomach ache went away but the diarrhoea continued. She had the diarrhoea almost every day since the shot, except 2 or 3 days. Back in Dec2019, they thought she had COVID since she had a large amount of antibodies so may not needed the second shot (as reported). She had bad diarrhoea after her first COVID vaccine for 10 days. After her second vaccine, it went away. She thought the second shot balanced it out. The outcome of the events was unknown. Follow-up (25Mar2021): This is a follow-up Spontaneous report from a contactable consumer. This consumer reported that no adverse event coded. Follow-up (31Mar2021): This follow-up contains no new safety information. Follow-up (07Apr2021): This is a follow-up Spontaneous report from a contactable consumer. This consumer reported that no new event (Not Coded).

Mid day on April 2, I suddenly developed vaginal bleeding then within 8 hours bleeding stopped. In the meantime, that afternoon I went to see Dr. and I was still bleeding when I went there. He did a biopsy and scheduled me to get a Vaginal ultrasound the next week. He also gave me some hormonal pills but my bleeding had stopped. For the next 25 days, I had no spotting, no bleeding or anything at all. At around noon time, on April 26, I began bleeding again but this time it wasn't bright red but it was a light brown color. By that afternoon, it had stopped. In the next 5 days, I had similar episodes but it got very light until it faded. Later on May 17, I had a very light yellowish brown discharge. Since then, this has been it.

I had mild covid in October, 2020 so when I got the Pfizer first MRNA vaccine in March, 2021, I felt ill and went to sleep. Then for weeks I had bowel inflammation (pellet poop) and on 4-20-2021 I went to the hospital with left heart pain, left shoulder pain, very fatigued, and difficulty breathing. This got worse over time and I ran a low grade fever, and doctors told me to take Tylenol. I flew on 5-17-2021 and on 5-21-2021, I was admitted to the hospital for 13 days, on oxygen, with pericarditis and pneumonia. Left lung had 600 mL fluid. No infection was found and final diagnosis was Post Pfizer covid 19 vaccine inflammatory syndrome with pericarditis. My miracle drug was anakinra injections which stopped my inflammatory response. I hope this helps others as I almost died. Dr made the diagnosis and I have all reports. My WBC (16.3) and CRP (298) rose until anakinra injections.

having a stroke or heart attack; high BP/Blood Pressure shot up to 210/110; back, shoulder and chest pain in the middle; had back pain; right shoulder pain; pain behind her neck; Vertigo so bad she had to hang on or stay close to things so she didn't feel like she was flipping over; big flare up of the vertigo; nausea/wave of nausea, very nauseous; felt like energy pressure up in her from the waist up; feeling cold and clammy; Cold and Clammy; This is spontaneous report from contactable consumer (reporting for self). A 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EW0186-H; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in arm right on 14May2021 at 14:35 as 1st dose, single dose for COVID-19 immunization (at the age of 68-years-old). The patient's medical history included ongoing underactive thyroid started 5-6 years ago and family history included relatives have had cancer. Concomitant medication included levothyroxine (LEVOTHYROXINE, 125mcg once a day) taken for hypothyroidism from an unspecified start date (started 5-6 years ago) and was ongoing. It was reported by the patient that on 14May2021, she received first dose of vaccine and the day after her vaccine on 15May2021, when she woke up, early in the morning when she takes her thyroid medication and she usually takes it at 07:00am every day and she keeps on schedule, but her stomach felt like it was going to flip, like she was going to vomit and she started experiencing vertigo and nausea and mentioned that vertigo was so bad she had to hang on or stay close to things, so she did not feel like she was flipping over and mentioned that states it had lessened a little bit, but not much and stated that a week after that, she had a big flare up of the vertigo, and she had to sit down in her wooden rocking chair with big arms and further stated that on 20May2021 it was night-time at 22:30 pm she got a very big wave of nausea and vertigo and her Blood Pressure shot up to 210/110, she had chest pain in the middle, not on the heart but the middle of chest, she was very nauseous, had back pain, right shoulder pain and pain behind her neck and she thought she was having a stroke and mentioned that she felt like energy pressure up in her from the waist up and she got cold and clammy. The patient further stated that she had her son call the paramedic at 23:00 pm and they took her to the hospital on the night of 20May2021 i.e., into the morning of 21May2021 because they thought she was having a stroke or heart attack and she was hospitalized, and they did tests for a couple of days. She reported that she has not gotten the second vaccine and she was not going to get her second vaccine at this time because she was still having the vertigo. She mentioned that she never had problems with high blood pressure, and she thought this might be one of the side effects. She was asking if there is a window of time that she has to get the second dose of vaccine and stated that the back and neck pain started to subside in route to the hospital and she had two more flare ups of chest pain in the hospital but everything besides the nausea and vertigo recovered by the time she was discharged, and they were taking her blood pressure every 15 minutes. The patient stated that she was hospitalized for three Days from 21May2021 to 23May2021. Therapeutic measures were taken to treat event was Nitro and Baby Aspirin and Blood Pressure Pill, Stress Test and went in and checked her heart. Stress Test was IV and Cat Scan or MRI to check her heart, cholesterol was excellent 90 but states they put her on a cholesterol medication to help her heart. Caller mentioned that they said that if anything was to happen, that helps the heart in a stressful condition, and it was a good thing to have on board. On an unspecified date in May-2021, the patient underwent lab tests and procedures which included Coronary angiogram which result showed no signs of obstruction, Cholesterol was 90 (units not provided) and stress test which result showed some Ischemia and on 20May2021 blood pressure was 210/110 (units not provided). The patient was recovered from vertigo on an unspecified date and on 21May2021 patient was recovered from the events of heart attack, back pain, shoulder pain and neck pain and on 23May2021 from hypertension, chest pain, feeling cold, clammy and felt like energy pressure up in her from the waist up and on 02Jun2021 from nausea. Follow-up attempts are possible, further information is expected.

Exactly a week after the first dose of Pfizer pt had a TIA. Was taken by ambulance to the hospital. Lost usage of right side and couldn't speak for roughly 30 mins. Pt states hospital found no reason for the TIA.

Her arm feels swollen at times and that it hurts so bad it feels strangled; soreness and pain all on the left side, muscle problems, joint pain in the elbow, wrist, 2-3 fingers usually the outside fingers hurt, painful ache in left shoulder, and sever arm pain.; Muscle problems; painful ache left shoulder; Underneath left armpit , zings when pressed in; started experiencing some difficulty; having a heart attack and was hurting everywhere especially the left arm; This is a spontaneous report from a contactable consumer or other non-health care professional. A 68-year-old female patient received dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration and administered in left arm on 13Feb2021 08:00 (age at vaccination was 68 years) as dose 1, single for COVID-19 immunization. The patient didnt had any vaccinations prior four weeks. No additional vaccines administered on same date of covid vaccine administration. The patient medical history include High Blood Pressure around the late 1990s, 2000s, diabetes mellitus from 2015. Patients concomitant drugs include hydrochlorothiazide taken for high Blood Pressure 25 mg once a day, losartan taken for High Blood Pressure 100mg orally once a day, metformin taken for blood glucose abnormal from 2016 1000mg twice daily. Patient first shot on 13Feb2021 around 8 PM that night, Saturday 14Feb2021 started experiencing some difficulty, by Sunday 15Feb2021 caller reports soreness and pain all on the left side, muscle problems, joint pain in the elbow, wrist, 2-3 fingers usually the outside fingers hurt, painful ache in left shoulder, and sever arm pain. She reports that she has been to the doctor and no one knows if it is from the Covid shot or not, she has had different test taken and no one can pinpoint what is going on. she thought she was having a heart attack and was hurting everywhere especially the left arm. She stated the pain ballooned and that is when she went to the doctor. having pain that runs from left shoulder down arm and around underneath the arm pit that zings when you put pressure on it, it causes pain. She said it hurt where her lymph nodes are. And she said the pain goes down to the fingertips. Patient said as far as the shoulder pain she is unsure if it is muscle pain or joint pain. But it is painful, and it aches. a scale of 1-10 she told the doctor it was a 10. Patient said she dont have fever. Her arm feels swollen at times and that it hurts so bad it feels strangled. Its like stopping dead in the water; she has not been good for the last 2 weeks and severe pain going down her arm. she has High Blood pressure and diabetes. she states this is part of the reason she got the vaccine as she is in the high-risk category. Events doesnt leads to hospitalization but require physician visit and emergency room. Therapeutic measures were taken as a result of events with steroid was Methylpred 4mg dose pack started 24Feb2021 and completed 01Mar2021. This was prescribed because doctor thought the steroids would help get everything under control of the pain. She also clarified that the muscle relaxer was Cyclobenzaprine which she spelled cylobenzap. She states the dose was 10mg orally and was prescribed to help the other medication work with to knock some of the soreness out. Medication was started 23Feb2021 and completed 01Mar2021. She does not have a lot or expiration for the Methylpred or the Cyclobenzaprine, states it was not on either bottle. She mentioned that these medications did not do very good. Declines to provide HCP information at this time but states she has been to see the doctor 16Feb2021. Lisinopril was changed to losartan because they had to try and get the right blood pressure medication for her and was changed in the late 1990s. She was on Lisinopril for 2-3 years. She has no lot number, expiration, or NDC to provide. Her appointment time was 7 pm but she received the vaccine somewhere between 7:30 an 8pm. she wanted to start life over again and do the things she did before. The patient underwent lab tests and procedures which included pain assessment: 10 on Caller says on a scale of 1-10 she told the doctor it was a 10, x-ray: unknown result on unknown date (she seen the doctor and got x-rays and all kinds of stuff). Second Covid vaccine is scheduled for this Friday. She stated she does not know what else to do, she is supposed to see the doctor this afternoon and is trying to gather information from Pfizer that can help them in any way. Caller reporting on COVID Vaccine. Caller mentioned she was taking Methylpred and Cyclobenzaprine and they did not help. Caller clarified the steroid was Methylpred 4mg dose pack started 24Feb2021 and completed 01Mar2021. This was prescribed because doctor thought the steroids would help get everything under control of the pain. She also clarified that the muscle relaxer was Cyclobenzaprine which she spelled cylobenzap. She states the dose was 10mg orally and was prescribed to help the other medication work with to knock some of the soreness out. Medication was started 23Feb2021 and completed 01Mar2021. She does not have a lot or expiration for the Methylpred or the Cyclobenzaprine, states it was not on either bottle. She mentioned that these medications did not do very good. Caller also mentioned detail about a historical medication which was Lisinopril. Lisinopril was changed to Losartan because they had to try and get the right blood pressure medication for her and was changed in the late 1990s. She was on Lisinopril for 2-3 years. She has no lot number, expiration, or NDC to provide for the Lisinopril. The outcome of events Muscle problems, Joint problems in elbow, wrist, and 2 outside fingers/soreness and pain all on the left side, muscle problems, joint pain in the elbow, wrist, 2-3 fingers usually the outside fingers hurt, painful ache in left shoulder, and sever arm pain, painful ache left shoulder, Underneath left armpit , zings when pressed in was not recovered and outcome of events started experiencing some difficulty, Her arm feels swollen at times and that it hurts so bad it feels strangled and having a heart attack and was hurting everywhere especially the left arm was unknown. No follow-up attempts are possible. No further information is expected.

Experiencing problems with memory, balance and feeling in right foot; Experiencing problems with feeling in right foot.; Experiencing problems with memory; On April 6 I suffered a stroke. It was minor.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EP6955), via unspecified route of administration in arm left on 27Mar2021 (at the age of 68-years-old) as dose 2, single and first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6205), via unspecified route of administration in arm left on 06Mar2021 (at the age of 68-years-old) as dose 1, single both the doses for COVID-19 immunisation. The medical history of the patient included myacins and codeine allergy from an unknown date and unknown if ongoing. The concomitant medications of the patient included just vitamins. 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 had been tested with covid-19 nasal swab and resulted negative on 06Apr2021. The patient reported on 06April I suffered a stroke. It was minor. Experiencing problems with memory at 16:30 and experiencing problems with memory, balance and feeling in right foot on an unspecified date. The patient visited Emergency room/department or urgent care. The patient was hospitalized for one day as a result of events. The patient underwent lab tests and procedures which included minor catscan (2); MRI; EKG; bubble test. Therapeutic measures were taken as a result of experiencing problems with memory and on april06 and suffered a stroke it was minor catscan (2); MRI; EKG; bubble test. The outcome of the events was reported as resolving. Follow up attempts are possible. Further information is expected.

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

3/24/21-3/26/21 headache, fatigue, 99.1 degree temp, sore arm 3/28/21 veins on lower left leg swelled irregularly like Whack-a-Mol and lump in one of them (diagnosed 4/14/21 as thromboplebitis) 3/28/21 migraine headache 4/3/21-4/9/21 very sore left wrist/wore wrist brace 4/7/21 new black spot on right ankle ( with history of melanoma): later biopsy (6/10/21 at Dermatology Clinic)=hemorrhage on right lateral malleolus, benign. April, May, June: unremarkable and variable ankle swelling in the evenings (have never had this issue before, but didn't note down the specific incidences- didn't think a lot about it.) 6/29/21 ankles swelled to the size of softballs!!! in the evening 7/2/2021 blood tests showed not issues 7/22/21 NutrEval tests done 6/23/21 showed high levels of inflammation

Swollen feet and ankles progressively worsening. Saw my doctor about it. Multiple lab tests,imaging tests,referred to a cardiovascular doctor. The Diagnosis was Bilateral Deep vein thrombosis. Blood test revealed tha I had a genetic mutation Factor V Leiden, Which is known to be associated with DVT. I am now on a blood thinner, Xarelto.

Patient complained of soreness in muscles morning after receiving the shot. She went about her day had a smoothie, spoke to people and also went for a walk came home and went into her jacuzzi tub and consequently passed away while in the tub. She was found by her husband at around 545pm, time of death is unknown and cause of death is currently pending.

Within 20-minutes of vaccination, the patient reported pain in their throat, SOB, tingling in their arms, and chest pressure. EMS evaluated patient on-site. Patient was hypertensive (184/96). 12-lead EKG was NSR, rate of 79 bpm, no ST elevation. FSBG was 137 mg/dL. ETCO2 was 40mmHg with normal square waveform. EMS initiated transport to Hospital Emergency Department. En route, patient became more hypertensive (200/106). In ED, she remained hypertensive and was admitted to inpatient telemetry unit. Patient had 1-night stay to rule out cardiac-related events. Anaphylaxis was ruled out. Discharged with diagnosis of vaccine reaction and chest tightness.

disoriented/disorientation; low oxygen saturation; acute CHF; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El3247, expiry date: unknown), via an unspecified route of administration on 23Jan2021 15:15 (at the age 69 years old) at a single dose, in the right arm for covid-19 immunisation. Medical history included fibromyalgia and polymyalgia. The patient's concomitant medications included other medications both prescribed and over the counter. The patient had no other vaccine in four weeks. The patient was not diagnosed with covid-19 prior to vaccination. On 24Jan2021 at 0900, the patient experienced disorientation that was present then went away and the patient seemed to be okay; low oxygen saturation and acute congestive heart failure (CHF). On Monday, she was disoriented again and went to emergency room (ER). All the events resulted in emergency room visit and hospitalization for seven days. The patient underwent lab test and procedures which included nasal swab covid test on 25Jan2021 which showed negative. Outcome of all the events was recovered on unspecified date.

she got the shot on 1/31/2021. Over the next 3 days she developed poor oral intake and diarrhea every 15 minutes; required hospitalization on 2/3/2021. Was hospitalized at Hospital. Hospital course was complicated by sepsis, pressors, intubation, GI bleed with ruptured rectum requiring surgery (ostomy). anticipated discharge 3/3/2021.

chest pain, subjective fever 9 days after vaccine; 10 days after hospital admit Dx with pericarditis + 8mm pericardial effusion

A day after the vaccine, she experienced shortness of breath. This worsened and as a result, triggered a COPD episode which also led to Tachycardia. Her heart rate was 170 and she could not breath. She had to be rushed to the hospital in an ambulance.

Swelling of tongue, throat, face, eyes, nausea I dose from Epipen Swelling came down but then came back 911 was called- transported to ER. Given a 2nd dose of Epinephrine en route which caused me to have an immediate heart attack

Pfizer COVID-19 Vaccine EUA 3/2: Pt received Pfizer vaccine 2/26/2021 and started feeling progressively worse - endorsed fever, diarrhea, body aches, trouble breathing, lack of appetite. On 3/2/2021 pt and husband presented to ED. Pt's husband stated that pt had become more and more confused since she received the vaccine and that on 3/2 she could not complete her sentences. Temp 101.6 on arrival, tachycardic in 130s, tachypneic in 120s, but not hypoxic. Patient was given acetaminophen on arrival. IV was inserted and patient was given 1 L intravenous fluid replacement as well as 2 g ceftriaxone for broad-spectrum coverage within 3 hours of arrival. Blood work was drawn that shows no leukocytosis but lactic acidosis to 3.3. There are multiple electrolyte abnormalities, hyponatremia 127, hypokalemia 2.8, creatinine 1.01, ALT 59 AST 53, ALP 136, total bili 1.3, lactic acidosis 3.3, troponin 0.02. Patient was given 40 mEq of oral potassium. Additional L of normal saline was given for total of 2 L normal saline bolus. Chest x-ray shows right basilar pneumonia. Also shows pulmonary nodule of which husband was made aware. LFTs are noted be elevated, so biliary ultrasound was obtained that was negative with limit to body habitus. Husband was updated. Azithromycin was added on. Rapid COVID antigen was negative. 3/3/21: Febrile, SOB overnight. Pt more lethargic, trailing off in the middle of sentences and having difficulties following conversation. Continue sepsis protocol, add vancomycin IV to ceftriaxone and azithromycin. Frequent neuro checks. MRCP. Chest pain-free, serial cardiac enzymes from yesterday to demonstrate nonischemic pattern likely type 2 NSTEMI. 2/2 blood cultures from 3/2 positive for Streptococcus pyogenes (Group A). Vancomycin and azithromycin dc'd. 3/11: Discharged from hospital. Patient admitted for acute hypoxic respiratory failure secondary to right basilar community-acquired pneumonia. Blood culture grew Streptococcus pyogenes, patient was initially treated with ceftriaxone and switched to Ancef . repeat blood culture on 03/04/2021 showed no growth. Patient will complete a total 14 day course of antibiotics with amoxicillin from culture negative date. Patient had right-sided pleural effusion, pulmonary consulted and she underwent thoracentesis x2 culture showed no growth, considered parapneumonic effusion. Patient required 2 L continuous oxygen and deemed stable for discharge. She will follow up with Pulmonary in 3 weeks, outpatient chest CT in 4-6 weeks to be ordered by Pulmonary to assess lung nodule and known thoracic aortic aneurysm. PTOT recommended home discharge with VNA. On discharge patient was a febrile and hemodynamically stable. Remained COVID negative throughout.

Patient received her first Pfizer COVID vaccination and subsequently experienced profound fatigue coupled with LUE/LLE weakness that persisted and was ultimately diagnosed with an acute CVA.

Delayed anaphylactic reaction - intense flushing of entire body with itching and hives, drop in BP, swelling of tongue

Being in the Mall, accompanied by her cousin, felt a severe headache and pain in both shoulders followed immediately by fainting, cardio-respiratory arrest that required call 911 for emergency transfer to Hospital. She was intubated in the emergency room treated by the doctors, Cardiologist and Intensive care where she was subjected to hypothermia and other treatments due to the serious neurological damage that she presented. No other organ seemed compromised. Never came out of the coma, passing away on February 26, 2021.

2/25 woke up at 7:30 a.m. with fever, chills, and severe body aches all day 2/26 same as previous day plus lethargy 2/27 woke up at 3:30 a.m. with SEVERE headache and partial loss of vision Went to ER and they diagnosed me with a moderate stroke and mild cognitive issues with right hemisphere vison loss in both eyes.

After 3 weeks , I came down with severe case of heart palpitations, body weakness ,cold body, shaking body, had to call 911 , in hospital was diagnose with Atrial Fibrillation, did not have this problem before!! Have to take 4 new medications for the rest of my life!!! I may experience stroke in the future. For a early few days had pain in my left arm. For the next few weeks overall tiredness. strange feelings in my head!!!!

I felt dizzy, nausea, felt unwell, weak, faint, started to slump over, was collapsing, hands turn red, tightness in the upper part of my body, lips tingling, tightness / swelling in my cheeks and mouth, very severe headache. I was rushed over to ER. Next day still had tingling of lips, felt unwell. By third day, felt better. I had an anaphylactic reaction to the vaccine. Three of my systems were adversely effected. Dr. and others are UNDERREPORTING the anaphylactic reactions cases. Just because I didn't die or an Eppie Pen was not given to me. doesn't mean I should not be included in the statistics.

Anaphylaxis. Patient began to have symptoms 5 minutes following the vaccine injection, was provided 50 mg IM benadryl at the site, another 50 mg IV en route to the hospital. Patient stated difficulty breathing and voice changes. Pt has history of anaphylaxis. She did not use her EpiPen, 0.3 MG of Epinephrine was administered at 550 pm in the ED. Patient discharged at 2208.

Stroke - globus pallidus area Lost ability to speak and recognize objects. Immediately taken to ER and evaluated and TPA given. Results good following drug administration sent home after two days. Some mental affects still.

Stroke; Nasal swab COVID test post vaccination/positive; This is a spontaneous report from a non-contactable consumer (patient). A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN6205, expiry date unknown), via an unspecified route of administration on 11Mar2021 at a single dose for COVID-19 immunization. Medical history included COVID-19 prior to vaccination on an unknown date. The patient's concomitant medications were not reported. The patient experienced stroke on 14Mar2021, two days (as reported) after having the vaccine. The event required an emergency room/department or urgent care visit and hospitalization for 2 days on unspecified dates in Mar2021. The patient received treatment for the event stroke and unspecified tests and monitoring was done. The event was also considered as a life threatening illness (immediate risk of death from the event) and has caused disability or permanent damage. The patient had a nasal swab COVID test post vaccination on an unspecified date in Mar2021 with a result of positive. The patient recovered from the event stroke with lasting effects while the outcome of the event nasal swab covid test post vaccination/positive was unknown. No follow-up attempts are possible. No further information is expected.

Vaccine 3/2/2021.Presented to ER 3/25/2021 with chest pain and found to have acute MI with completely occluded left main coronary artery with clot causing cardiac arrest, cardiogenic shock. Currently Critically ill, intubated, high risk mortality.

This is a 70 year old female with paroxysmal atrial fibrillation (anticoagualted on Eliquis), obstructive sleep apnea (uses CPAP), mitral valve regurgitation, remote tobacco use, hypertension and dyslipidemia who presents to the ED for worsening dyspnea, cough, subjective fever, chills and body aches that have been ongoing for the past several days. The patient indicates that her dyspnea is exacerbated with exertion but she denies chest pain, pleuritic chest pain, leg swelling or calf pain. She mentions that she has received both of her COVID-19 vaccines (Pfizer); the first immunization was on 02/25 followed by her second immunization which took place eight days ago on 03/18. She is not confident that she has had any contact with a known sick or definitive COVID-positive individual recently. Of note, the last documented incidence of testing for COVID-19 was performed on 10/31/2020 after the patient was seen at a Clinic after a exposure for a COVID-positive individual. Testing at that time had resulted negative. To her knowledge, she states that she had, in fact, tested positive for COVID-19 in late fall of 2020, but she was not hospitalized. Yesterday (3/26/2021), she was evaluated at a Pharmacy where she was testing for COVID-19 which has since resulted positive. The patient denies any other acute symptoms of illness. In the ED, the patient was found to have acute respiratory failure with hypoxemia and pneumonia due to SARS-CoV-2 infection. Review of Systems Constitutional: Positive for chills, fatigue and fever. Negative for activity change. Respiratory: Positive for cough and shortness of breath. Cardiovascular: Negative for chest pain and leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Positive for arthralgias and myalgias. Negative for gait problem. Neurological: Negative for syncope. All other systems reviewed and are negative. Vitals Blood pressure 159/79, pulse 65, temperature 36.4 °C (97.5 °F), temperature source Oral, resp. rate 18, height 1.6 m (5' 3"), weight 107 kg, SpO2 98 %. Physical Exam Vitals reviewed. Constitutional: General: She is awake. She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is morbidly obese. She is ill-appearing. She is not toxic-appearing. Interventions: Nasal cannula in place. HENT: Head: Normocephalic and atraumatic. Nose: Congestion present. Mouth/Throat: Mouth: Mucous membranes are dry. Pharynx: Oropharynx is clear. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Decreased breath sounds present. Comments: Diminished breath sounds in all lung fields. Occasional cough. Abdominal: General: Bowel sounds are normal. There is no distension. Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion and neck supple. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Psychiatric: Behavior: Behavior is cooperative.

Multifocal Intracerebral Hemorrhage; Disseminated Intravascular Coagulopathy; strokes, Ischemic and Hemorrhagic; strokes, Ischemic and Hemorrhagic; AML; Leukemia; Blood clot diagnosis; Sore lower leg; RDW Stand. Dev. H/RDW Coeff Var H; Platelet Count L, Platelet Vol L; Neutrophils L; Band Neutrophils H; Monocytes H; Metamyelocytes H; Myelocytes H; Absolute Neutrophils L; Other Cell Type Blast Like Cells H; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9261, via an unspecified route of administration, administered in Arm Right on 02Feb2021 08:30 (Batch/Lot Number: EL9261) as SINGLE DOSE for covid-19 immunisation. Medical history included breast cancer (8 years ago no chemo just radiation). Historical vaccine included first dose of BNT162B2 (lot number: EL0140) on 11Jan2021 for Covid-19 immunization. Concomitant medication included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium citrate, colecalciferol (CALCIUM CITRATE + D3), glucosamine, magnesium citrate, docosahexaenoic acid, eicosapentaenoic acid, tocopheryl acetate (OMEGA 3 [DOCOSAHEXAENOIC ACID;EICOSAPENTAENOIC ACID;TOCOPHERYL ACETATE]) and curcuma longa (TURMERIC [CURCUMA LONGA]). On 04Feb2021, the patient's blood work result showed red cell distribution width (RDW) stand. dev. high; RDW coeff var high, platelet count low, platelet vol low; neutrophils low; band neutrophils high; monocytes high; metamyelocytes high; myelocytes high; absolute neutrophils low; other cell type blast like cells high. On 15Feb2021, the patient experienced sore lower leg. On 16Feb2021, the patient was diagnosed with blood clot. On 19Feb2021, the patient was diagnosed with leukemia. On 20Feb2021, the patient was diagnosed with acute myeloid leukemia (AML). On 21Feb2021, the patient had tow types of stroke, ischemic and hemorrhagic, the patient was intubated. On 23Feb2021, the patient was extubated and died due to multifocal intracerebral hemorrhage, disseminated intravascular coagulopathy, acute myeloid leukemia with blast crisis. The patient received chemotherapy and leukapheresis as treatment. The patient died on 23Feb2021. An autopsy was not performed.; Reported Cause(s) of Death: Disseminated Intravascular Coagulopathy; Acute Myeloid Leukemia With Blast Crisis; Multifocal Intracerebral Hemorrhage

Anaphylactic reaction: full body rash; Anaphylactic reaction: full body rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at 69-year-old on 22Feb2021 (lot number: EL9267, expiration date unknown), at single dose for COVID-19 immunization. Medical history included cardiac disease, triple bypass operation, diabetes, thyroid, high blood pressure, known allergies: penicillin. The patient was not diagnosed with COVID prior vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccine in four weeks. On 01Mar2021 the patient experienced anaphylactic reaction: full body rash. The event resulted in doctor or other healthcare professional office/clinic visit. The COVID was not tested post vaccination. The patient received treatment for the events, included unspecified medications. The outcome of the events was not recovered.

3/13/21 Pt presented to an urgent care with generalized aches, chills, HA, diarrhea and cough. Nasal swab was positive for SARS-CoV-2 and she was diagnosed with COVID-19. 3/17 She presented to ED w/ cough, HA, weakness and decreased appetite. Room air pulse ox was 88%. She was found to have bilateral infiltrates on CRS and was hyponatremic. She was admitted to the hospital on oxygen and decadron.. On 3/18 she was weaned off oxygen. She was discharged to home on 3/19 to complete a 10 day course of decadron.

Started having shortness of breath on Tuesday, 9 March 2021. Continued 10 March 2021. Admitted to local hospital. Tests revealed bilateral pulmonary embolism. On Heparin drip until released 12 March 2021 on Eliquis. Difficulty breathing on Saturday, 13 March 2021. Diagnosis elevated white blood count from 9000 to 14000. Tests done. Released with antibiotics and pain meds. Nothing since then.

Immune thrombocytopenia purpuria; bleeding of gums, nose, skin pricks; bleeding of gums, nose, skin pricks; bleeding of gums, nose, skin pricks; platelet count of 1000; This is a spontaneous report from a contactable nurse reported for herself. This 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number ELU266), via an unspecified route of administration at single dose in left arm on 20Feb2021 12:45 for COVID-19 immunisation. Medical history included allergies to medications penicillins, ceclor, statins, environmental; diabetes; hypertension; asthma; gastrooesophageal reflux disease. The vaccine was administered at Health Clinic. Concomitant medications included rabeprazole, clonazepam, montelukast, venlafaxine hydrochloride. On 22Feb2021, the patient experienced immune thrombocytopenia purpuria, bleeding of gums, nose, skin pricks, platelet count of 1000. Therapeutic measures were taken as a result of the events included steroids, IVGM, platelets, PRBC, iron, antibiotics. The outcome of the events was recovering. The patient was hospitalized and condition was life threatening. The patient underwent lab tests and procedures which included platelet count: 1000 on 22Feb2021, SARS-CoV-2 test: negative on 07Mar2021.; Sender's Comments: A contributory role of the vaccine BNT162B2 to reported events cannot be excluded based on plausible temporal relationship and lack of alternate explanation at this time. 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.

blood clot in the lung; my left leg from the knee down started to swell; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; my left leg from the knee down started to swell, get really hard and became very painful/I could hardly walk and after and pain was so intense; blood clot in the leg; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN3248, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 16Feb2021, 15:30 PM at a single dose for covid-19 immunisation (age at vaccination was 69 years). Medical history included blood pressure and thyroid. Concomitant medication patient received within 2 weeks of vaccination included levothyroxine, valsartan, furosemide, acetaminophen. No other vaccine was received within 4 weeks prior to the COVID vaccine. On 16Feb2021, 3 hours after the patient received the vaccination at 18:30 the patient's left leg from the knee down started to swell, got really hard and became very painful. She could hardly walk and afterwards the pain was so intense that she went to the doctor. Doctor took X-rays of her left leg on 16Feb2021, then he diagnosed her with blood clots. He gave the patient 2 heparin shots and immediately sent her to the hospital for a deep vein ultrasound on 16Feb2021. The results showed blood clot in the leg. The patient was prescribed medication and sent home. Her leg continued to be rock hard and painful. On 02Mar2021, the patient was sent for a blood panel work up. There was no improvement. On 08Mar2021, the doctor sent her for a lung CT scan. On the same evening, the patient was called to the doctor's office and was sent to ER immediately as the results showed blood clot in the lung. The patient's dose of Eliquis was doubled. This has now been going for 5 weeks, the patient had not been without pain during this time. Her left leg hardness had gone down a little but was still twice the size of her right leg, knee was huge. The swelling never goes down, not even at night. No covid prior vaccination and no covid tested post vaccination was reported. This case was reported as serious. The outcome of all the events was not recovered. No follow-up attempts are possible. No further information is expected.

Thrombosis pulmonary; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced thrombosis pulmonary. Outcome of the event was unknown. Information on the lot/batch number has been requested.

Sudden after 19 days of the vaccine severe abdominal pain and facial swelling, abdominal distention , i noticias facial swelling around parotids and subliminal área, no fever they take me to emergency, the pain was very intente 10/10.

Blood clots developed in lungs. Felt restricted breathing beginning approx. 2 1/2 weeks after 2nd shot. She had an online dr visit and was diagnosed with pneumonia, which appeared to be an error. She took a ZPac for 5 days, but the pain persisted. She then went to the ER April 9th to learn of blood clots and then found cancer. It is uncertain if the vaccine played a role, but we are reporting due to the timing.

Weakness in left leg, blod clots in lungs, severe headaches continuing I went to emergency on February 23, 2021 where I treated for weakness in left leg and was admitted to hospital where I received treatments for a double pulmonary embolism on March 1.

Patient developed left leg pain and swelling a few days after receiving her second Pfizer COVID19 vaccination. She was seen in the ER and found to have extensive iliofemoral DVT of the left leg. She was taken for a venogram and thrombectomy and then started on Eliquis.

Adverse effects chronology: Mar 25 sore arm only Mar 26 cough, diarrhea, dizziness, fatigue, loss of appetite Mar 27-30 all symptoms intensified daily, intermittent chills started on 29th Mar 31 all symptoms intensified, started using Albuterol inhaler Apr 1 all symptoms intensified, room spinning dizziness resulted in fall, temperature 99.9F Apr 2 Hospital emergency room, covid tests negative, diagnosis: diverticulitis and pneumonia. 3 intravenous antibiotics started metronidazole, clindamycin, rocephin Apr 3 admitted to hospital floor, continued antibiotics Apr 4 electrolyte infusion series started Apr 5 cough lessening, continued antibiotics and electrolyte infusions Apr 6 covid test negative Apr 7 transferred to rehab facility, continued antibiotics, electrolyte drinks Apr 8-14 antibiotic courses allowed to expire, symptoms improving, appetite returning slowly (lost 15 lbs), negative covid test Apr 15 released to home Apr 16 diarrhea stopped, slight dizziness remains, appetite improving

A-Fib caused by thyroid issues, potassium too high and/or blood pressure being too high. Had never had thyroid issues or any problems with potassium. Had no blood pressure issue since on medication.

Took first Pfizer Covid 19 vaccine on March 5, 2021, second dose on March 19, 2022. Suffered stroke from blood clot on April 2, 2021.

Three days following first vaccine, in otherwise normal state of health, patient began experiencing right arm weakness and slurred speech lasting < 5 minutes. Occurred x2, fully remitting on each occasion.

This 69 year old female received the Covid shot on 3/10/21 and went to the ED on 3/14/21 and was admitted on 3/14/21 with weakness, lack of appetite, malignant neoplasm of brain and lung and died on 4/18/21. 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.

hypovolemic shock secondary to nausea and vomiting Had eaten frozen fish cooked in an air fryer two hours previously--had previously cooked the same fish by the same method without ill effect. No ill contacts. Not social gatherings. Lives by herself and is afraid to be near anyone Incidental finding of pulmonary embolus on evaluation--see below. No prior h/o VTE

Patient reports symptoms of right hand numbness and weakness and slurred speech. These occurred around 7:30 pm but it is unclear exactly what day they happened as one physician noted the day of the vaccine and another noted 2 days after the vaccine. The slurred speech resolved in 5 minutes but the hand continued to have some numbness and tingling. Patient was referred to the neurologist who diagnosed a TIA and ordered further workup. Patient was found to have calcified plaques in the left proximal internal carotid artery with severe stenosis. She was referred to vascular surgery for an endarterectomy. During the process of clearing her for surgery she was seen by a cardiologist who requested that this event be reported to VAERS.

Severe pain in left leg, swelling, hot Sever pain in upper body-left side only--from jaw, to shoulder, to arm to side, front and back, all the way to the hip CT scan at hospital--pulmonary embolisms in both lungs, blood clot diagnosed in left leg at vascular surgeon's office before going to the ER Now on XARELTO for life.

Woke up from a deep sleep at 11:30 pm with my heart racing and irregular heart beat. Called 911 and they took me to the Hospital I was having an Atrial Fibrillation episode that took about 4 hours to subside. I was given Cardizem IV drip for 3 doses before it resolved. Was admitted to the hospital for approximately 36 hours.

Patient is a 69-year-old woman with newly diagnosed pericarditis in March 2021, hypertension, hyperlipidemia, and hypothyroidism, who presented to the Emergency Department (ED) with progressively worsening chest pain, dyspnea, and fatigue. Patient was in her usual state of health until 3/1/2021, when she developed sudden-onset pain "across the entire chest". She shares that her symptoms "came out of the blue", as "suddenly one day, everything just hurt". She saw her primary care physician, who initially felt her symptoms were due to acid reflux. As such, the patient started "eating antacids and omeprazole like candy". However, her chest pain persisted, prompting her to follow up with her primary care physician on 3/16/2021. At that time, ECG reportedly showed normal sinus rhythm and no acute changes. CT of the chest, abdomen, and pelvis with contrast showed abnormal enhancement and thickening of the pericardium with trace pericardial fluid, consistent with pericarditis. The patient was therefore started on colchicine and an ibuprofen taper. On 4/5/2021, Patient sent a myVM portal message to her primary care physician and cardiologist, expressing her belief that her chest pain has remained unchanged over the past month. She continues to experience a constant burning sensation throughout her chest, aggravated by deep inspiration and alleviated by lying flat on her back. She shares that walking up the stairs at home leaves her "breathless". Associated symptoms include subjective fevers, chills, and night sweats. Given these symptoms, Patient underwent a chest x-ray, which showed findings consistent with an enlarging pericardial effusion. Patient was then advised to present to the ED for further workup as an inpatient. At time of hospital admission, patient endorses persistent chest pain during inspiration. Prior to 3/1/2021, she has never experienced these symptoms and reports no history of pericarditis. The most strenuous physical activity she has undertaken in the last month include working in the garden and caring light boxes down the stairs. She is most concerned about the fluid around her heart. Patient reports no nausea, vomiting, palpitations, constipation, diarrhea, or abdominal pain. Of note, the patient developed pericarditis 10 days after her second COVID-19 vaccine. Hospital Course # Sub-acute pericarditis with enlarging pericardial effusion Pericarditis initially diagnosed in March 2021, thought to be potentially from her COVID-19 vaccine given time course as no other clear etiology apparent. Pt was hemodynamically stable with an elevated jugular venous pressure at time of admission, with CXR consistent with an enlarging pericardial effusion. Echo 04/05 with small circumferential pericardial effusion but no tamponade physiology. Cardiac MRI on 4/7 with enlargement of moderate-sized pericardial effusion but otherwise negative exam, with no evidence of myocarditis or infiltrative myocardial process. ANA screen negative, rheumatoid factor and anti-CCP not elevated Blood cultures x 2 with no growth - CRP continued to remain > 160 with ibupofen and colchicine. Prednisone 20 mg PO daily was added on 4/7, with subsequent improvement in patient's symptoms. - Discharged on regimen of prednisone 20 mg PO daily and colchicine 0.3 mg PO daily (reduced from 0.6 mg daily that she was taking prior to admission). She will also continue using ibuprofen 800 mg BID. - Follow-up with Dr (cardiology) next week to follow-up on hospitalization and decide upon tapering plan for her medications

Patient felt sick after her second shot on April 6th 2021. On April 17th she was admitted to the hospital with a septic infection and nearly died. She remains in the hospital. She is being treated with antibiotics. She will have a 3 week stay in the hospital if her treatment goes well. She has done no traveling and barely leaves the hospital. Also, the dr are not able to pinpoint what the source of the infection is.

blood clot in my lungs/Multiple blood clots; Pains; This is a spontaneous report from a contactable consumer. This 69-year-old female consumer reported for herself that: Patient characteristics: Weight (kg): 102.97 Height (cm): 165 Sex: Female Relevant medical history and concurrent conditions: Structured information (Patient episode name): Hypertension Patient Medical comments: Verbatim: Hypertension Reaction(s)/Event(s): Reaction/event as reported by primary source: Blood clot in my lungs within the first 2 weeks after the second shot Reaction(s)/Event(s): Reaction/event as reported by primary source: Hospitalization Reaction/event in MedDRA terminology (LLT): Hospitalization Reaction/event MedDRA term (PT): Hospitalisation Reaction(s)/Event(s): Reaction/event as reported by primary source: Pains Results of tests and procedures for investigation of the patient: Test: CTA scan More information available (Y/N): No Drug(s) Information: Characterization of drug role: Suspect Proprietary medicinal product name: Covid-19 Vaccine Batch/lot number: ER8732 Date of start of drug: 30Mar2021 Action(s) taken with drug: Unknown Drug(s) Information: Characterization of drug role: Concomitant Proprietary medicinal product name: Lisinopril HCTZ Dosage text: 20-25 mg Tablet Indication for use in the case: Hypertension Narrative case summary and further information: Case narrative: Selected Report Type: Initial Patient Ethnicity: (Ethnicity withheld) Is the patient also the reporter? Yes Reporter type: Consumer or other non-health professional Reporter telephone: (Phone no withheld) Primary / Prescribing Healthcare Professional Info Dates for Blood clot in my lungs within the first 2 weeks after the second shot.: (From: Unspecified To: Unspecified) Dates for Hospitalization: (From: Unspecified To: Unspecified) Dates for Pains: (From: Unspecified To: Unspecified) Is Covid-19 Vaccine a Pfizer product? Yes Covid-19 Vaccine manufacturer: Unspecified Dates for Covid-19 Vaccine: (Start: 30Mar2021 Stop: Unspecified) NDC number of Covid-19 Vaccine: Unknown UPC number of Covid-19 Vaccine: Unknown Expiry Date of Covid-19 Vaccine: 31Jul2021 Other Products: Yes Dates for Concomitant Products Lisinopril HCTZ: (Start: Unspecified Stop: Unspecified) Patient History: Yes Patient history: Hypertension (From: Unspecified To: Unspecified) Investigation Assessment: Yes Investigation: CTA scan (Date: Unspecified, Result / Units: ) Additional Context: Consumer stated, "I could not follow on the parts. So may be should have done certainly but I am not technically astute. So, I wanted to report that I just had the second Covid-19 test and as a experience in emergency room discovery of blood clot in my lungs within the first 2 weeks after that second shot. So, I wanted to report that. Is this the place I do that?" When paraphrased, consumer stated, "Multiple blood clots." Start date of event (Multiple blood clots.): Consumer stated, "10Apr2021. I should probably say that the pains were 09Apr. I went in the emergency room on the 10th. So, I am not sure which day." Treatment :Consumer stated, "Yes, I went To the emergency room and was kept in the hospital and then I saw my own Doctor just today who is going to help me try to determine what is going to happen next ? I was released by the hospital." Details of hospitalization: Duration of hospitalization: 24 hrs. (overnight) Date of Admission:10Apr2021 Date of Discharge:11Apr2021 Lab work: Consumer stated, "They did lab. work while in the emergency room and in the hospital. They did Chest CTA scan." This is a spontaneous report from a contactable consumer. A 69-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation at age of vaccination 69-year-old. Medical history included hypertension from an unknown date. Concomitant medication included hydrochlorothiazide/lisinopril (LISINOPRIL HCTZ) taken for hypertension, start and stop date were not reported. The patient experienced blood clot in my lungs/multiple blood clots (thrombosis) (hospitalization) on 10Apr2021 with outcome of unknown , pains (pain) (hospitalization) on 09Apr2021 with outcome of unknown. The patient was hospitalized for blood clot in my lungs/multiple blood clots (thrombosis) from 10Apr2021 to 11Apr2021. The patient was hospitalized for pains (pain) from 10Apr2021 to 11Apr2021. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on , laboratory test: unknown results on . The action taken in response to the event(s) for bnt162b2 was not applicable. Therapeutic measures were taken as a result of blood clot in my lungs/multiple blood clots (thrombosis), pains (pain).

4-16-21 @ 2PM SHE HAD A 'SHADOW IN HER RT EYE'. DROVE TO ER. DX WITH CLOT TO RT EYE AND LT OCCIPITAL AREA OF BRIAN. NO SURGERY. WAS GIVEN PLAVIX. HAS APPT WITH EYE DOCTOR ON MAY 3RD. SAW A NEUROLOGIST AND PCP. SHE IS DOING BETTER NOW AND RT EYE HAS 'CLEARED UP'. WILL NOT BE GETTING SECOND DOSE.

blood clot in her lung; Shortness of breath; blood pressure dropped extremely low; blood pressure fluctuates; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247), via an unspecified route of administration, administered in the left arm on 17Mar2021 at the age of 69-years-old as single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient previously received the first dose of BNT162B2 on 24Feb2021 (Batch/Lot number was not reported) at the age of 69-years-old for COVID-19 immunization. On 07Apr2021, the patient experienced shortness of breath and blood dropped extremely low. On 08Apr2021, the patient experienced blood clot in her lung. And on Apr2021, the patient experienced blood pressure fluctuates. The patient had her final Pfizer Covid vaccine on 17Mar2021. The patient reported that she had to go to the hospital for shortness of breath and her blood pressure dropped extremely low. She stated that they did tests and found out she had a blood clot in her lung. The patient reported that she came home Sunday evening and took the drip thing out and started her on blood thinner that started with an E (as reported). The patient stated that she was told her cardiologist told her to report this. The patient wanted to know if there have been any other reports called in about people calling in with blood clots. The patient was hospitalized due to events shortness of breath, blood dropped extremely low, and blood clot in her lung from 08Apr2021 to 11Apr2021. The patient reported that her blood pressure fluctuates. She stated that it was better than when she was in the hospital. They gave her the drip. The patient reported that her values did come down and this was the only thing they could go by. The outcome of the events shortness of breath and blood pressure dropped extremely low was recovering. The outcome of the events blood clot in her lung and blood pressure fluctuates was unknown.

blood clot; lymphadenopathy; unable to walk without a cane; her left leg swelled up dramatically; painful leg; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (at the age of 69-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient received Pfizer shot a few weeks before reporting. Within 3 hours her left leg (she was inoculated on the left side) swelled up dramatically - - it was painful. Subsequently - a doctor discovered numerous blood clots in that leg; then a blood clot in one of her lungs. She was being treated but the lymphadenopathy has not subsided in her leg and she was now unable to walk without a cane. Lymphadenopathy was not resolved; the outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Pulmonary embolism; tested positive for Covid/shortness of breath/severe cough/headache; tested positive for Covid/shortness of breath/severe cough/headache; This is a spontaneous report from a contactable nurse (patient). The nurse reported similar events for herself and her daughter. This is the first of two cases. A 69-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), the first dose administered in the right arm on 14Mar2021 (Batch/Lot Number: EN6208) and the second dose administered in the left arm on 03Apr2021 at 10:45 (Batch/Lot Number: ER8737), both intramuscular as a single dose for COVID-19 immunization. Medical history included diabetes and high blood pressure both diagnosed 5 years ago, GERD and hypercholesteremia, all ongoing. The patient was a former smoker but has been smoke-free for 15 years. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for hypercholesterolaemia from an unspecified start date and ongoing; lisinopril (manufacturer unknown) taken for high blood pressure from an unspecified start date and ongoing; metformin (manufacturer unknown) taken for diabetes from an unspecified start date and ongoing and omeprazole (manufacturer unknown) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. The patient did not have any prior vaccinations within 4 weeks of the COVID vaccine. The patient reported that she and her daughter had their second dose of the vaccine on 03Apr2021. The patient tested positive for Covid. The patient developed shortness of breath on Sunday, 11Apr2021, and ended up with a pulmonary embolism. The patient doesn't know if she was possibly infected before they got the second vaccine and were asymptomatic and unknown or did they get infected when got they got the vaccine with thousands of other people. At the time of the report, the patient was mostly resolved and they are all home. She became short of breath, had severe cough and headache and she went to the ER and on the CAT scan they discovered she had a small pulmonary emboli. She was hospitalized from 11Apr2021-12Apr2021. The patient was given Eliquis and monoclonal antibodies as treatment for the events. The patient stated that she will be on Eliquis for the next month because of the pulmonary embolism. The patient did not need any additional therapies for COVID-19. The patient did not have any pre-existing diseases that worsened during the SARS-CoV2 infection. The outcome of the event 'tested positive for Covid/shortness of breath/severe cough/headache' was not recovered while the outcome of the event pulmonary embolism was recovering. The relatedness of the suspect drug to the reactions was unknown.; Sender's Comments: Based on the information provided by the reporter, it appears reasonable that the suspect drug did not contribute to the development of the reported event pulmonary embolism, that most likely was related to the concurrent development of COVID-19. 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) : US-PFIZER INC-2021413236 same reporter and drug, similat event, different patient

Sudden fatal heart attack. Patient went from a medically well person of 69 and died suddenly of PES within 2 weeks of dose. Patient reported arm pain, fatigue, and coldness to extremities

N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness N93.9 - Abnormal uterine and vaginal bleeding, unspecified

Patient developed B/L LE DVT 1 week s/p 2nd vaccine; This is a spontaneous report from a contactable physician. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on Apr2021 (Batch/Lot number was not reported) as 2nd dose single for covid-19 immunisation. The patient medical history was not reported. Patient was not pregnant. Concomitant medication included estradiol taken for menopausal symptoms, start and stop date were not reported; acetylsalicylic acid taken for an unspecified indication, start and stop date were not reported. No other vaccines received withing 4 weeks. The patient developed B/L LE DVT 1 week s/p 2nd vaccine on 27Apr2021. Event resulted in physician's clinic visit and was given anticoagulation. Outcome of the events was recovering. Patient was not diagnosed with COVID prior to vaccination and had not been tested post-vaccination.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported DVT and the use of BNT162B2 cannot be fully excluded. However, the age of the patient and use of estradiol may confound the reported drug event pair. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

passed away sometime after 2/16/21 and before 2/20/21 in her home. Cause of death ruled by Corner as Myocardial infarcation and congestive heart failure. Sometime between 11 and 15 days after receiving dose 1. did not receive dose 2 due to her passing before she could receive it.

right breast has been diagnosed with cellulitis; her right arm which is where the second injection site was, not just the site but her whole right arm swelled; Her voice was still weird; they think she has lymphoma; He thought it caused a severe case of laryngitis; She is all upset and hyper; He thinks it's stress; wheezing and sounded horrible; Mid left pillar idiopathy and subcarinal area neoplastic disease; mediastinal mass effect; they thought she was having a stroke; She lost her voice all of a sudden. She couldn't talk; seemed completely out of it; swollen lymph nodes/enlarged lymph node in her right lung/swollen lymph nodes on her right breast; mass in her throat; panic attack; experiencing some difficulty breathing; anxiety; This is a spontaneous report from contactable consumers (one is the patient's husband) received via medical information team and from a Pfizer-sponsored program. A 69-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EP7533, expiration date not reported), via an unspecified route of administration on 11Apr2021 12:00 (at the age of 69-years-old) at 2nd dose, single in the right arm for COVID-19 immunisation. Medical history included ongoing Hashimoto's disease from an unspecified date (had it for years), basal cell cancer, and the patient's immune system was compromised. It was reported that the patient's father had lymphoma and passed away due to kidney cancer. The patient's mother died at the age of 97-years-old, and was healthy. Concomitant medication included levothyroxine sodium (SYNTHROID) from an unspecified date and ongoing for Hashimoto's thyroiditis. Historical vaccine included first dose of BNT162B2 (lot number: ER8727) received on 21Mar2021 15:00 in the left arm for COVID-19 immunisation. It was reported that the patient experienced swelling on left arm where the injection was and little bit of swelling in the lymph nodes in armpit. The patient's height was 163cm, and weight was 68.01kg; both on unspecified dates. He patient's husband reported that something was happening with his wife (patient), and he cannot find the patient's symptoms on the website. It was reported that the patient had the second shot of Pfizer vaccine 3 weeks ago, this past Sunday. The second shot was given in the patient's right arm, and the first shot was given in the left arm. Everything was normal for close to three weeks. Then on Sunday, on 24Apr2021, the patient lost her voice all of a sudden. She couldn't talk, seemed to be completely out of it, and the patient's husband thought that she was having a stroke. They went to the ER (emergency room). The doctor though that the problem was that the scented detergent the patient used for her mask. The doctor thought that it caused a severe case of laryngitis. The patient was sent home. The patient's voice was still weird last week. It was also reported that the patient's right arm, and breast were swelling. On 2021, the patient experienced some difficulty breathing and anxiety. Two days ago, on 02May2021, the patient noticed that her right breast on the same side as the second shot was enlarged, heavy, and firm. The patient has no history of breast cancer. A couple of days prior (in 2021), the patient's arm was swollen. It was her whole arm. The patient was scheduled to see her dermatologist at 11:30 this morning since she was having a basal cell cancer removed from her face. The patient was all upset and hyper and was having trouble breathing a little bit. The patient's husband thought that it was stress. The patient was scheduled for surgery on her face on Wednesday this week and the patient had a panic attack on an unspecified date in 2021 so the patient was brought to the emergency room. The patient's husband stated that this was because the patient was scheduled for a surgery for basal cell cancer removal, and that the patient's breast being so large, the patient was worried. The patient had Hashimoto's disease for years, and her immune system was compromised. The extra swelling could be because her immune system was working overtime. The patient's voice was good for a while, but today, she was losing it again. The patient uses different laundry detergent now. The patient's husband stated that these never happened before, and that it could be coincidental. The patient had no reactions prior to the 3-week period after the shot. The patient was wheezing now, and the patient's husband may need to call an ambulance. The patient's husband further stated that he took the patient to the hospital (emergency room) this morning because the patient was wheezing and sounded horrible. The hospital record stated that the patient had an enlarged lymph node in her right lung and that her right breast was swollen and infected. The patient was currently in the emergency room and was not admitted to the hospital. The patient was going to have a biopsy today. After the patient's first dose, she had a little swelling on her left arm where the injection was and a little bit of swelling in the lymph nodes in her armpit. The patient's husband noticed that the patient's right arm where the second injection site was, not just the site but her whole right arm swelled, from shoulder to wrist. The patient's husband also noticed that the patient's right breast was huge. On 05May2021, the patient had MRI and CAT scans which showed "extensive mediastinal mass effect continuous from right to left side with greatest dimension of 10cm. Mid left pillar idiopathy and subcarinal area neoplastic disease". She was having a biopsy done today at the hospital". The patient's lymph nodes were swollen in the area between her lungs. On 05May2021, the patient had her COVID test which showed negative result. It was then reported that the biopsy was going to be either Ebus (as reported), which is where a tube was put down the throat, and if that did not work, there would be a mediastinoscopy performed and after that, there is a possibility that CAT scan will be done. The patient's husband reported that on Apr2021, the patient's right breast was diagnosed with cellulitis so the patient received a couple of IV (intravenous antibiotics) for the breast and it slightly improved. The patient's cellulitis could lead to sepsis that's why she was treated with IV antibiotics. The patient's MRI on an unspecified date showed that the patient's breast was clear of any swollen lymph nodes and potential cancer. The patient was also given IV antibiotics for breast enlargement, breast swelling, and breast infection. On Apr2021, the patient experienced side effects mass in her throat, swollen lymph nodes on her right breast, and cellulitis. The patient will be undergoing a biopsy today, because they think that patient has lymphoma. It was reported that the patient received her vaccination at a huge vaccination setup at a local high school. The patient was hospitalized for 3 days (unspecified dates) due to the events breast enlargement, swelling arm, breast swelling, breast cellulitis, and breast infection. The patient's husband also stated that the patient was brought to the emergency room for because the right arm started swelling and that the right breast was huge, then was taken to the hospital room that night. No other vaccine received within 4 weeks prior to the COVID vaccine. Outcome of the events breast cellulitis, and loss of voice was recovering, for events swelling arm and panic attack was recovered on an unspecified date, and for other events was unknown.

Death E87.1 - Chronic hyponatremia N17.9 - AKI (acute kidney injury) (CMS/HCC) J18.9 - Pneumonia of right lower lobe due to infectious organism

Abrupt syncope with cessation of pulse and respirations at 11:15AM at main office. CPR was started by the workers present. 911 activated and code was activated by EMS and continued during transport and arrival at ER. All resuscitation efforts failed to restore breathing and cardiac activity. A large amount of blood was encountered upon intubation, so Dr. informed next of kin that cause of death was likely a large pulmonary embolus.

Blood Clot on brain. Taken by ambulance from home at 11:? to Hospital. CT Scan, Injected with blood thinner on steroids, Life flighted to Hospital. Surgery to remove blood clot. 5 days in hospital.

69 y.o. female that presented to my office with a 5 day history of weakness on her right side. In particular, she states her right arm, right face, and right torso was numb when she woke up on Saturday morning, May 29th. She initially thought she just had some radicular symptoms going down her right arm as she has had before. However, she does admit that the facial numbness did concern her. She had a headache that morning, but no headache after that. She states that some of the sensation has come back a little bit in the right arm and hand. However, she still can not hold anything without up falling out of her hand because she can not feel it. She denies any weakness in the right side of her body. She denies any facial droop. She does think her vision may have gotten a little bit worse, but this is difficult to tell because she does usually have poor vision. Because of her symptoms in the office, I thought it was best that I admit her for observation in order to rule out acute stroke. I sent her for a stat head CT which did come back showing a subacute left-sided CVA. Further workup is underway. Active Hospital Problems Diagnosis Date Noted ? Right sided numbness 06/02/2021 ? Acute cerebrovascular accident (CVA) (HCC) 06/02/2021 ? Essential hypertension 01/27/2021 ? Dyslipidemia 05/22/2017

On April 3rd I woke up with a fast heart beat. I have one of the meters that give oxygen and beats per minute and it was registering at 41 and then it wasn't registering at all. After an hour I was dizzy and light headed. I was wasn't feeling right. I went to ER and my heart was beating at 240 beats per minute. They give me diltiazem. They though it was Atrial fibrillation. At 9:15 my heart went into a normal rhythm. They put me on diltiazem and put me on Eliquis to prevent strokes until I could get to a doctor later on in the week. When I left the hospital it was at normal heart beats at 72 beats per minute. I went to Dr. on April 12th. He thought it was SVT or Atrial fibrillation for sure. He referred me to an electro physiologist. I went in for an ablations on May 4th. They suspected I had Atrial fibrillation and SVT before the vaccine.

I had the PFIZER EW0167, at @1pm on 5/5/2021. Thé second dose was scheduled for 5/26/21; however, I canceled it because of what I went through. Three days after taking the vaccine, Saturday, May 8, 2021, I had four mini-strokes simultaneously. 911 was called and was taken to Hospital. On Friday, May 14, 2021, I had another stroke. After being discharged on Tuesday, May 18, 2021, I returned to the hospital on Wednesday, 28, 2021, with weakness and unable to stand or walk without two assists. I was very happy it was not another stroke, but my potassium and magnesium were so depleted, that the doctors were trying to figure out what happened. I had three treatments of potassium, two orange drinks and one through intravenous, and four treatments of magnesium with two pills each time. I am afraid to take the second vaccine as I now had six strokes; also, the cardiologist have found that my heart was spitting out lots of blood clots at an alarming rate, so they had to give me I.V Heparin, now I am on Eliquis. I am asking to look into this, as the vaccine is new. I was excited to get the vaccine, now I am honestly scared. Thank you,

I am the epidemiologist for reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/14/21 after the completion of a full Pfizer vaccine series (Dose 1 on 2/28 and Dose 2 on 3/21). The patient later died on 5/08/21. Cause of Death is listed as ?cardiopulmonary arrest; Anoxic encephalopathy; V. Fib cardiac arrest; Myocardial infaction?. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, IMMUNOCOMPROMISED CONDITION Case went to Hospital ER on 4/14 after experiencing chest pains for 2-3 days. Rapid COVID test on 4/14 was negative & PCR test on 4/14 was positive. Case remained in ER for retesting on 4/15 (PCR - negative) so she could be admitted to hospital for cardiac catheterization. Case reports having a mild fever at hospital on evening of 4/15 & morning of 4/16. Hospital Internist DX was mild case of COVID with elevated enzymes that indicated a cardiac event. Case is fully vaccinated (1st dose of Pfizer 2/28 & 2nd dose of Pfizer 3/21). Case has history of lupus & rheumatoid arthritis (immuno-suppressed). She receives PT 2-3x/week & biologic treatment (last infusion of Orencia was 4/13). Advised case to follow-up with her PCP & cardiac specialist. Case agreed to isolation guidelines. Case lives alone but has 2 adult sons who live nearby that will provide food drop-offs at door. Emailing vaccination breakthrough info to Epidemiologist & supervisors.nnn=======================nnApril 15, 2021 at 3:28 PM ET Left SMS/VM.

I had chest sweats after my 1st dose of Pfizer vaccine for several days. I suffered a heart attack 20 days after the first vaccine. I fainted after the 2nd vaccine & went to urgent care & Hospital emergency room & then to another Hospital where I had an Angiogram which confirmed that I had a heart attack on April 5, 2021, the day before my 2nd vaccine.

I was out walking and I suddenly felt vertigo and severe pain in my neck, shoulders, and back. I went to the closest friend's house and he stated that I was dropping things/wasn't clear...rushed me to the hospital ER where the doctors thought I was having a heart attack; therefore, they ran some tests to find out. I was discharged with information about signs to look for in reference to heart attacks and asked that my PCP refer me to a Cardiologist for further evaluation.

On 6/23/21 patient suffered from a STEMI. Cath did not show any major occlusions so thought to be plaque rupture vs vasospasm.

So I had the shot on March 28, 2021 and let's see if I can remember the date, I'll get my calendar which will help me a little bit, so it started the end of April 2021. I noticed a difference in my breathing, I had not been active and I just didn't feel very good. On the 28th of April I was feeling very weak, feeling like a wimp, I couldn't do anything without feeling very exhausted. Then on May 5 2021 I told my husband I just was not feeling right, I had to sit down just when getting dressed. I went to the bathroom and I felt like something was really wrong, I could not even walk around without feeling tired. On May 5 2021 I called my son who is an RN and he took my BP and heart rate, but my oxygen was 91 and then 87 again when he tested again. He said he felt I had a pulmonary embolism, they called my cardiologist. The DR told me to go to the hospital and they did an EKG and took me to an ER room to do a chest x-ray. They said there was something on my chest so they did bloodwork. He then said I had blood clots on both my lungs. Then later on that night they did ultrasounds of my legs. They found a deep vein thrombosis. They then broke the news that I was not going home, that they were going to admit me. I ended up in a monitored room for four days. They put me on oxygen and wires. 4,000 units of heparin drip w/ 2,0000 units per hour. They then switched me to Luvanox and Coumadin. They could not figure out why this happened to me. They found no infections, nothing cancerous or anything. They sent me home with blood thinners (coumadin) all the time. Then two weeks later I woke up in the middle of the night with a lot of pressure on my chest and I went to the ER again. I was never admitted, they just checked me. Then two weeks later again it happened and I went to on call, they took pictures of my heart and everything again and they could not find anything. They did a study of sleep on me and they found I have a sleep apnea problem. They are recently now working on my sleeping problem and I will be admitted and studied over night on the machines. In between all this I also went to my PCD and now that is to current, up to date is what has been happening recently.

Cryptogenic Stroke-permanant partial loss of vision in right eye, incomplete motor control on left side.

7.11.21: Patient presents to ER with shortness of breath. Has history of receiving Pfizer COVID-19 vaccine on 4/16/21. Found to be hypoxic and COVID-19 positive. diagnosed with acute hypoxic respiratory failure and viral sepsis due to COVID. Started Remdesivir. 7.15.21: completed 5 day course of remdesivir. discharged home.

On 7/11/2021 patient became hypoxic with oxygen saturation of 83% requiring supplemental oxygen. Did not improve and on 7/14/2021 and was sent to the hospital. She was diagnosed with bilateral pulmonary embolus and was found to be in A flutter with RVR.

This is a solicited report based on the information received by Pfizer. A non-contactable consumer (patient) reported that a 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Injection), dose 1 via intramuscular in Feb2021 at age of 69-year-old single dose for COVID-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneously from an unspecified date to an unspecified date, at unspecified dose for moderate to severe adult Crohn's disease. The patient's medical history and patient's concomitant medications were not reported. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. In Feb2021, the patient experienced bleeding. The event was reported as non-serious. The action taken in response to the event for adalimumab was unknown. The outcome of the event was resolved on 15Apr2021. The reporter's causality for the event of bleeding with Humira (Adalimumab) was no reasonable possibility. The reporter's assessment of the causal relationship of the event with the suspect product 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. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

70 yo female with 1-2 weeks ongoing URI symptoms including cough, SOB, fevers, nausea, sore throat, headache. Denies chronic lung issues. States she had her Pfizer vaccinations in march 2021. He presented to the ED on 7/19/21 and was found to be COVID positive. CXR with patchy infiltrates. She also developed acute hypoxic respiratory failure and was started on heated high flow nasal canula. She is receiving remdesivir, decadron, and tocilizumab.

Congestive Heart Failure, I was healthy prior and heart issues. medical records to prove of heart. I had surgery 3/3/2021, ekg good. Less than 7 days after vaccination, couldn't breath, eat, difficult walking any distance, couldn't lay down to sleep, couldn't really sleep sitting up, shortness of breath. Cardiologist gave a diagnosis of CHF stage C, I was hospitalized for 3 1/2 days. They wanted to keep me longer, I asked to be released. Cardiologist thought I had a viral infection to the heart, still working on improving the heart. Adhering to CHF rules for medicine and diet.

vaginal cramping; spotting; This is a spontaneous report from a non-contactable consumer, the patient. A 69-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 11Mar2021 at 10:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from an unspecified date. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 06:30 the patient experienced vaginal cramping and spotting the morning after the vaccination was received. The clinical outcome of the event spotting vaginal, cramp was unknown. No follow-up attempts are needed. No further information is expected.

Patient was light headed after returning to her vehicle post vaccination. Then she started to have heart palpitations. EMS called an ambulance and put her on a heart monitor. She showed mild Atrial Fibrillation. EMS wanted client to go to the ER but she refused. No other symptoms or treatment that I am aware of.

At approximately 10:30pm on 1/14/2021, resident was noted to have a rash on her face, hands, arms, and chest. VS:100.2, 113, 20,108/59, 84% room air. applied nasal cannula at 4-L, telephoned Physician orders 6mg Decadron one time order, a second set of Vitals , reads 99.3, 110, 20, 106/60, 90% on 4-L N/C. On coming shift advised. At approximately 2:00am on 1/15/2021, resident congested and coughing. BP 151/70, pulse 124, temp 98.1 forehead, resp 20 and pulse oc 79% on 3L. At approximately 2:30am PRN cough syrup and breathing tx. Resident's condition began to worsen with breathing tx. This LPN updated at 0248 doctor on resident's condition. Doctor gave permission for resident to go to hospital. At 4:19am the Er called to say resident passed away.

Went into a sustained A fib event at approximately 8:30 pm approximately 11 hours after receiving vaccine. Entered ER and was treated for A fib with A fib lasting approximately 10 hours with cardiziem administration and continued to be hospitalized for another 6 hours for monitoring for stability.

Resident was noted on 1/25 with an increased functional decline as she would not feed herself with utensils, but would eat finger foods if placed in her hand. She was started on Rocephin IM for possible infections. Labs had been obtained on 1/21/21, unremarkable for CBC and CMP. 75,000 colony count on urine. On 1/26/21 she was noted with right sided weakness and further decline. She was sent to Hospital for further evaluation. We were notified that she expired on 1/28/2021. Resident had been noted with a decline in function about 2 weeks earlier when she would not stand or transfer any longer. She was still responsive, taking meds, and feeding herself until 1/26/21. Further information on admitting diagnoses and progress notes from hospital have not been available to date.

Very tired with small headache on Jan 30. Monday, Feb 1 awoke to a fib situation. Went to ER and was cardioverted back to regular rhythm

My mother died suddenly on February 3rd. She went into shock/cardiac arrest and appeared to have internal bleeding. No autopsy has been performed. Unsure if it was related to the COVID vaccine.

Patient tested positive for COVID-19 on 2/4/21, she had symptoms of cough and sore throat on 2/2/21. She was admitted to hospital on 2/12/21 COVID-19 pneumonia and hypoxic respiratory failure.

Pt initially had diffuse joint pain, then worsening pain and swelling in RLE. Had DVT u/s + for DVT No history of blood clots, no prior risk factors Cannot be certain that she did not have clot prior to vaccine, although she never had pain or swelling to this degree (1-2 mo prior thought skinny jeans were slightly tighter on R than L, but no visible swelling. Now with RLE 2x size LLE)

Flu like symptons about 4 hrs after vaccine(Thurs)...left arm, muscles, joints hurt, chills, tired, not feeling well. most symptoms disappeared after 24 hr however right ankle and leg continue to hurt (FRI and SAT) and by Sun. calf on right leg hot red and swollen. Mon called my physician and went to hospital for sonogram on right leg. Results were a blood clot on the back of my leg from ankle to knee. Xarelto was prescribed as blood thinner and taken. Tuesday appt. with Doctor for consultation and blood work was prescribed with follow up appointment March 2 . My concern is taking second dose of Pfizer vaccine on Mar 4. My doctor and I will discuss. On internet others have reported this same side affect of blood clots from 2 days to 2 wks after. This needs to be addressed.

2/7/21 Increased difficulty chewing, swallowing, evaluated by SLP and dietician. Diet texture down-graded x 2 with poor appetite and recent 6lb weight loss. 2/8/21-APRN updated regarding poor appetite and difficulty chewing as well as downgraded texture of diet. Also informed of increased s/s of discomfort and increased use of PRN Oxycodone for pain. 2/9/21- elevated temp 100.7. 2/9/21 Covid pcr test negative. 2/9/21-N.O.?s APRN BMP, Albumin and Pre-albumin Level in am. 2/11/21-elevated temp 100.4. Covid rapid test negative. 2/12/21- CBG recorded at 517 at 5:20 am. Resident also has an elevated temp of 100.9. Tylenol administered per order. Vital signs include resp 24, radial pulse 134, O2 sat 83%. Supplemental oxygen administered via nasal cannula. Head of bed elevated. DR. notified at time via telephone. Order given for sliding scale for CBG. Guardian updated regarding changes in residents condition, poor prognosis. Guardian requests Hospice eval and admit. Guardian requests comfort care no hospitalization, no IV's, no G-tubes, no labs etc, D/C of Palliative services. ARNP informed. 2/12/21 Acute Telehealth visit with APRN due to increased lethargy, elevated CBG?s despite poor appetite and insulin administration. Resident unresponsive to verbal and noxious stimuli at time of visit. N.O. Morphine sulfate 20mg/ml, give 2.5mg PO/SL Q4hr PRN pain/shortness of breath. 2/12/2021-Admitted to Hospice, Lethargic, diaphoretic, T 98.1 P 130's R 18 O2 high 80's to low 90's via O2 mask at 3L. 2/12/2021- Resident legs and arms noted to feel cool this afternoon, 02 sat was 97% with 02 on @ 3L with mask Noted resident with sob and increased pulse. Prn morphine 0.25ml sl. given with good effect. Resident was less restless and quiet in her bed. Checked on resident several times this shift for needs. Resident noted to not move in her bed @ 8:15pm and noted she was not breathing. Supervisor called and pronounced resident deceased.

nauseous; severe stomach cramps; shortness of breath; chest tightness; diaphoretic; chilled; cold to the touch, ashen; cold to the touch, ashen; patient was treated as if a heart attack; This is a spontaneous report from a contactable healthcare professional (patient). A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Jan2021 15:30 at a single dose for Covid-19 immunization. Medical history included high BP, and cholesterol. Patient had no known allergies. Concomitant medications included amlodipine and simvastatin. The patient experienced nauseous, severe stomach cramps, shortness of breath, chest tightness, diaphoretic, chilled, cold to the touch, ashen on 01Feb2021 at 15:30. Ambulance was called, patient was brought to the ER and was hospitalized on an unknown date for 2 days. Treatment of events: patient was treated as if a heart attack, nitro, baby aspirin. Patient was not diagnosed with Covid-19 prior to vaccination. Patient has not tested positive for Covid-19 after vaccination. Outcome of the events was recovered. Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completely excluded based on a compatible temporal relation. Case will be re-assess 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 RAs, Ethics Committees, and Investigators, as appropriate.

did I have a heart attack. No doctor will see me to give me an EKG; Collapsed; Crushing chest pain; chest was killing me and hurting and I was sobbing and it lasted about an hour and 15 minutes; Side of my neck hurt; My back hurt; It was just awful; Lethargic; I ended up vomiting for 2 days after the chest pain receded; slept for 16 hours; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients (husband and wife). This case refers to the wife with serious adverse events. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiration was not reported), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included acid reflux. Concomitant medication included dexlansoprazole (DEXILANT) for acid reflux. Patient reported that she had terrible severe reaction on the 22Jan2021. They were vaccinated on the 18Jan2021 and on the night of the 22Jan2021, she had such crushing chest pain that she just collapsed. Her chest was killing her and hurting and she was sobbing and it lasted about an hour and 15 minutes. The side of her neck hurt and her back hurt. It was just awful. Patient reported that she have called everybody. She have called her doctor's assistant and she confused her. Patient reported that they just went in because they were 70 and 71 and got the vaccine but then she ended up vomiting for 2 days after the chest pain receded and they took baby aspirin and then she just vomited and vomited and slept for 16 hours. They were both very lethargic. She asked her what should she do. She does not know if this was a reaction to the vaccine or did she have a heart attack. No doctor will see her to give me an EKG. They say they are not seeing patients. The patient recovered from chest pain on an unspecified date; while outcome of the remaining events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021115775 same reporter/drug, similar event, different patient.

She has high blood pressure; she developed Afib; This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old female patient received bnt162b2 (BNT162B2; Lot # EN5318) vaccine, via an unspecified route of administration on 25Jan2021 at single dose for Covid-19 immunisation . The patient medical history was not reported. There were no concomitant medications. The patient developed atrial fibrillation on 29Jan2021 with outcome of unknown , she has high blood pressure on an unspecified date with outcome of unknown. The patient laid down and she could feel her heart beating real fast. She has high blood pressure so she went to taking her blood pressure and her heart rate was like 100. On Sunday night of that week it got worse and her blood pressure got higher so she called 911 and they took to the ER. She says this was her first ever episode with Afib she never had it before this. The patient was treated with metoprolol and rivaroxaban (XARELTO). The patient underwent lab tests and procedures which included blood pressure measurement: high and heart rate: heart rate was like 100. Both the reported events were considered serious because Important Medical Events. Follow up information has been requested.

?1/6/21 hospitalization after her 1st dose on 1/2/21 ?2/15/21 hospitalization and 2/28/21 death after 2nd dose on 1/16/21

Pfizer-BioNTech COVID- 19 Vaccine EUA: Wife of patient called Primary Care Physician to inform that patient had received dose #2 of Pfizer COVID vaccine, and later that evening experienced a seizure and expired.

shortness of breath; A fib; Had water in my lungs; This is a spontaneous report from a contactable consumer (patient self). A 70-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT number and expiration date: unknown) via an unspecified route of administration (location: left arm) on 29Jan2021 at age of 70-year-old at single dose for COVID-19 immunisation. Medical history included high blood pressure, diabetes. She had known allergies: Penicillin. The patient had a history of atrial Fib (Atrial fibrillation) but had been in sinus rhythm for a long time. No COVID prior vaccination. Concomitant medication included dabigatran etexilate mesilate (PRADAXA). On 30Jan2021 09:00 AM, after first dose of BNT162B2, she went to the emergency room (ER) with shortness of breath and in A fib (Atrial fibrillation), she also had water in her lungs. The events were resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient stayed for 5 days in hospital. She received unspecified medications as treatment. COVID tested post vaccination (Nasal Swab) on 22Feb2021 resulted negative. The outcome of events was recovering. Information about lot/batch number has been requested.

severe asthma; trouble breathing; might have the coronavirus; My face is blood red; I am worried; Wheeze; she is also shaky; general malaise; heart attack; and last night she drank some water and choked on it then couldn't get her breath and; chest was hurting radiating to my arm down; fever; chills; exhausted/just felt very tired; her arm that was sore was the one where she had her injection; This is a spontaneous report from a contactable consumer (patient). A 70 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EM9810), via an unspecified route of administration (on left arm) on 15Feb2021 (at the age of 70 -years-old), single dose for COVID-19 immunization. Medical history included asthma, sleep apnea, thyroid problem, prediabetes, cpap use, all from an unknown date. There were no concomitant medications. Patient reported her face is blood red. Last night her chest was hurting radiating to my arm down. It felt like someone was strangling her with water. She noticed my symptoms were what people experience after receiving the second dose. She had fever, chills, exhausted and just felt very tired after receiving the first dose. She still have trouble breathing. She had severe asthma. She was not breathing normally. When she put the mask on it's even harder to breath. She was worried. She thinks, she might have the coronavirus. Consumer says that she is still not feeling well after receiving her first dose of the Pfizer COVID-19 vaccine on February 15th. She says that the first day after getting it, she had pain in her arm, it was achy, it was not really painful enough to where she had to take Tylenol for it. She says yesterday on the second day she had fever, chills, tiredness, general malaise, and today she is not feeling well. Caller says she was having trouble breathing, and did a treatment with her nebulizer which she has because she has real bad asthma. She says her breathing is labored and she wheezes every once in a while. She says she would like to see if there is anything that she needs to do, because she works with children, and if she is coming down with the corona virus she doesn't want to be around them with it. She says that her breathing is problematic today. She says she doesn't think that she is having a severe reaction, she has no rash or those kind of symptoms. She says it seems to be just the asthma, and last night she drank some water and choked on it then couldn't get her breath and her chest hurt and she had pain down her arm and thought oh gosh she was having a heart attack.Caller says she has done no treatments other than the nebulizer treatment. No further details provided about the nebulizer treatment. Caller says the provider said no Tylenol right away, so she didn't take any yesterday with her fever, and she didn't have a thermometer to take her temperature, but her face was really hot and she was having chills, which usually means she has a fever. She says that her arm that was sore was the one where she had her injection. She says that never really was that bad, everyone said their arm had ached, and she has a high pain threshold so it never bothered her. Her wheezing and little trouble breathing was better, after she did some breathing treatments with the nebulizer, she is not breathing well but she is breathing better. She says she is also shaky and doesn't know if that is just nerves, or if this is also something going on. Caller says that it has been a while since she had blood work, which was the last time she went to see physician, but she doesn't know the results for what they found out. The outcome of the events Breathing difficult,wheeze was recovering, other events was unknown.

right leg showed blood clot in lower back of leg from ankle to knee; right leg calf was red swollen and throbbed; Right leg ankle still hurt; flu symptoms appeared; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; Left arm, muscles, joints hurt; tired; chills; not feeling well; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female non-pregnant patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 11Feb2021 10:00 at single dose in arm left for COVID-19 immunisation. There was no medical history and no known allergies. Concomitant medication included colecalciferol (D3) and multi vitamin. The patient did not have COVID prior vaccination. There was no other vaccine in four weeks. After about 4 hours after first Pfizer shot on a Thurs (11Feb2021), the patient experienced flu symptoms appeared, Left arm, muscles, joints hurt, chills, tired, not feeling well, on 11Feb2021 16:00. Right leg ankle still hurt after 24 hours Friday and Saturday by Sunday. Right leg calf was red swollen and throbbed on 14Feb2021 16:00. Monday (on 15Feb2021) the patient called physician and had sonogram on right leg which showed blood clot in lower back of leg from ankle to knee. Doctor put immediately on rivaroxaban (XARELTO) blood thinner for blood clot. Blood work has been done on 15Feb2021. The patient would follow up on 02Mar2021. She was concerned about taking second COVID vaccine dose on 04Mar2021. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Covid was not tested post vaccination. The event outcome was unknown.

my blood pressure was high; Was told that I have Congestive Heart Failure , which I did not have before the Vaccines .; watering my lungs; watering my lungs; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient (not pregnant) received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration in left arm on 18Feb2021 13:00 at single dose for COVID-19 immunization. Medical history included ongoing high blood pressure, diabetes, penicillin allergy, sinus rhythm (had been in sinus rhythm for a long time), atrial fibrillation. No Covid prior vaccination. Concomitant medication included dabigatran etexilate mesilate (PRADAXA). The patient previously took first dose bnt162b2 in left arm on 29Jan2021 at the age of 70-year-old for COVID-19 immunization and after the first vaccine, patient went to the ER with shortness of breath and in A fib (atrial fibrillation). Had water in patient's lungs, stayed for 5 days. After the second vaccine in Feb2021, patient's blood pressure was high. Back to the ER, watering patient's lungs, Stayed for another 5 days. It was told that patient had Congestive Heart Failure, which patient did not have before the Vaccines. AE resulted in: [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization]. The patient was hospitalized for the events for 5 days. The patient underwent lab tests and procedures which included Nasal Swab: negative on 22Feb2021, blood pressure measurement: high in Feb2021, blood pressure measurement: high on unknown date. Therapeutic measures were taken as a result of events (unspecified medications). The outcome of the events was reported as recovering. Information on the lot/batch number has been requested.

reveled mild pneumonia; I tested positive for Covid19 19Feb (3 weeks +2days) after 2nd dose of vaccine; I tested positive for Covid19 19Feb (3 weeks +2days) after 2nd dose of vaccine; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262; expiry date: unknown) via an unspecified route of administration in the left arm, on 28Jan2021 at 15:00, at a single dose, for COVID-19 immunisation. Medical history included known allergies to penicillins. Concomitant medication included acyclovir (ACICLOVIR). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284) in the left arm, on 06Jan2021 at 13:00, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID-19 vaccination. The patient had dry cough and difficulty getting deep satisfying breath about 12Feb2021 (2 weeks + 2 days) after 2nd dose of Pfizer vaccine. The patient tested positive for COVID-19 nasal swab on 19Feb2021 (3 weeks +2days) after 2nd dose of vaccine. On 24Feb2021, patient was seen in a physician office for symptoms of cough and shortness of breath (SOB). On the same day (24Feb2021), chest X-ray revealed mild pneumonia. Patient was now on prednisone, azithromycin and albuterol inhaler. Patient was a little better and was now on 3rd day of taking 3 medications. Outcome of the events was recovering.

syncope; afib; afib; soreness, redness, and pain at injection site/left arm pain/under arm pain; soreness, redness, and pain at injection site; her blood pressure was really high and kept going up and down like a roller coaster; She was taken to the ER and began feeling sick to stomach in ambulance; headache; felt her ears vibrating; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; Breast, arm and clavicle starting hurting two weeks and one day after the injection; She is anxious about getting the second vaccine; Enlargement of lymph nodes; increased heart rate; This is a spontaneous report from a contactable Nurse reported for self. This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Feb2021 on Arm left at single dose (Lot # EL9262, Expiration: May2021) for covid-19 immunisation. Medical history included Atrial fibrillation from Jan2020. Had 2nd dose appointment scheduled but canceled appointment. Concomitant medications included apixaban (ELIQUIS) from 07Feb2021 at 5mg twice a day by mouth (provided SN100089537925, LOT 1771228, EXP: May2023, NDC: 0003-0894-21) for Atrial fibrillation. History vaccine included a Tetanus shot 40 years ago (1981) for immunisation and reacted terrible to it. She reports having and experienced soreness, redness, and pain at injection site. She reports getting a mammogram sometime after receiving the vaccine. They saw a spot they are going to recheck and saw swollen lymph nodes on the left side/ Enlargement of lymph nodes, which is the same side she received her vaccine. She was told it was most likely due to the vaccine. Six days later she suddenly felt sick, near syncope, couldn't catch her breath. It got so bad she thought she was dying and called EMS. Leads confirmed afib, her blood pressure was really high and kept going up and down like a roller coaster. She was taken to the ER and began feeling sick to stomach in ambulance. IN the ER she received 1000 ml of fluids and additional metoprolol in addition to dose she took that evening at home. She was sent home to follow up with her Cardiologist the following Monday. He wasn't sure if it was due to vaccine and started her on twice daily eliquis and increased her toprolol immediate release to twice daily. The following Friday night she got a headache and felt her ears vibrating. Her home EKG was fine, but blood pressure was high again and stayed up for hours. Took additional toprolol. Came down after 5 hours. Breast, arm and clavicle starting hurting two weeks and one day after the injection. She is anxious about getting the second vaccine. Asked PCP if she needed an antigen test to see if she needed a second dose of the vaccine. She says she got her first dose 01Feb, then on Wednesday, 03Feb she went and got a mammogram which had already been planned. She says that they saw enlarged lymph nodes to her left breast, under arm, and clavicle which they said are due to vaccine, but they also said they saw something else so they wanted to do a repeat mammogram three months later. She says it took two weeks, but suddenly her left breast and under arm were killing her, caller did not clarify this statement. She says she talked to her doctor who said don't worry it might take a while to go down. She says that the other thing is she has known atrial fibrillation that was diagnosed a year ago, and most of the time it is quick and doesn't last long, sometimes she doesn't know she is having it. She says 6 days after the first dose she started to feel ill, she had been in bed reading so she got up to get some water and suddenly felt like something was wrong and like she was going to pass out, she couldn't breathe, so she called EMS. She says her atrial fibrillation is not unusual, but she has never had it to where she couldn't breath. She says that the rate they estimated was 350, and her only other documented that was high like that was 150. She says that they treated her and she went home, and when she saw her cardiologist they said they don't know if the vaccine had to do with this, and to report it. She says a week later, on Friday a week ago, she started feeling funny standing while she was working on the computer in the middle of the afternoon, she felt like her ears were vibrating, which was very unusual, and she didn't know what was wrong so she looked at her Cardia app, and her heart was in normal sinus, and she checked her blood pressure which for her was sky high, up to 190/100 which her blood pressure is usually very low. She provided a second blood pressure that call handler was unable to capture and caller did not clarify as she no longer had her log with her. She says for hours her blood pressure (BP) went up and down, which was a similar or same thing as what happened that night she went to the ER with her atrial fibrillation, her BP would go up and down like riding a wave. She says needless to say, she has two questions: she says she doesn't know if there have been reports of that vaccine making A-fib worse, she is scared to get her second dose which she was supposed to get Monday a week ago, but put off primarily before the second thing with BP, she thought she would wait because she could hardly move her left arm so she put it off until the next Wednesday, She says that her second dose is now scheduled for 03Mar, so 4 weeks between doses, and she is a little afraid to get it because she doesn't know if her response was over the top or caused the other things, going to the ER with A-fib was terrifying, and she doesn't want that to happen again. She says people say that she has got to get her second dose because she won't be protected, so she would also like to know if it is possible for her to get antigens early on. She says that she had a tetanus shot 40 years ago, and had a horrible reaction after it, then years later they did a titer for tetanus and they said she would likely never need a tetanus shot again since she had built up such a high level and would never need it again. She says is it possible that she had enough immunity that she wouldn't need the second dose, or would there be an antigen test that could tell her if she would need a second dose, if so what is that test? She says she is afraid the next dose will kill her. AE treatment included says that when she went to the ER it was about 12:30AM when she arrived, they did not admit her. She says on the way to the ER in the EMS truck they gave her Cardiozyme to get her blood pressure going down and gave her 1000 cc fluids, and Metoprolol, another dose. She says that the Cardiozyme was IV push in the ambulance, she doesn't have the information to provide for all of the heart stuff they gave her, NDC/LOT/EXP: Unknown for Metoprolol or Cardiozyme. She clarifies that she takes Metoprolol normally every day that they have had her on that is extended release and she takes it at night. She says she had taken that at 09:30PM, and by the time she got there to the ER after midnight a little, they after gave her another to see if it would bring her heart rate down. She says that they kept her there a couple of hours, until her heart rate was normal, though her BP was up a bit. She says that they told her they could admit her but she said she would rather go home if they thought it was safe, and she went home. She says that her sister came home and stayed with her, whose husband is a cardiothoracic surgeon. Metoprolol: Caller says that the Metoprolol she is taking is in a pharmacy bottle that says use by 08Feb2022, it does not have an official label, the NDC or LOT are not on there. She says that they gave her 60 to take of regular Metoprolol, not extended release, which is 25mg to take twice a day by mouth, so 60 tabs and she would need to get refills as it is a months worth. Metoprolol extended release NDC/LOT/EXP not provided when queried. She clarifies that the not extended release is called Toprol/Metoprolol Tartrate 25mg. Caller says that her swelling lymph node limited the use of her arm, she can't pick up anything or lift her self up while moving in the bed, she is miserable, it hurts to put pressure on her arm and she can hold her arm up and move it around she can do anything with not holding anything, she feels a tightness there, even when she breathes or coughs. She says her left arm was sore initially for 3-4 days after getting the shot but the soreness left. She says she was told on 03Feb that she had swollen lymph nodes, which was two days after the shot, but she couldn't feel them then, she couldn't tell, and had no pain. She says it was two weeks later that happened, it was so odd that it was two weeks before it was hurting then got progressively worse. Caller says that Tuesday a week ago she thought she must have done weights with her arms since her muscles were sore, but it was only on one side and she hadn't done any exercise since after she went to the ER she was being careful what she did, and she thought she strained her arm and realized what it was, it has gotten progressively worse over the last week. She says last night she started looking up remedies, she has been putting ice on it, and the clinic said use warm, and she rubbed castor oil on it last night in the shower then this morning she massaged her arm with castor oil and put a warm wash cloth over it. She says that castor oil has anti inflammatory properties. She says she has not noticed a difference yet, but she has only done it two times. She says it also said she can take Aleve or Ibuprofen, they told her at the ER, they also started her on Eliquis the night she was there, which she had never been on, they didn't consider her A-f fib bad enough. She says that is what has her concerned, she got the shot then 6 days later A-fib made her feel like she couldn't breathe. She says also her BP and heart rate going back up made her sick to her stomach that subsided when her BP was coming down but then it started going back up again, when she went to the ER that Saturday night on the 6th but by the time she got there it was the 7th. Outcome of the events was unknown.; Sender's Comments: The possibility that suspect drug may have contributed to the reported event cannot be excluded. 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.

I started to have tingling sensation to my left leg. I have history of DVT, hemochromatosis, hyperthyroidism but is all managed. The issue is that the tingling sensation I was experiencing was moving in my left leg, was painful but then it went away. I went to the emergency room 02-25-2021 that started with a blood clot and they placed me on Xarelto medication. My PCP encouraged me to go to the ER. they did an U/S of my left lower extremity which showed blood clot. I am already on blood thinner medication and no one can explain or give me an answer as to why I have a blood clot after my vaccine when i am on blood thinner medication.

Patient presented to emergency department in afib RVR with heart rate in 180's. Patient has no known history of afib, and stated that the heart rate of 180 started several days prior to arriving to emergency department. Patient was given IV push of 15mg cardizem, heart rate came down to 130. Patient then placed on cardizem drip at 10 mg/hr. Afib still present, but heart rate controlled in 120's. Patient underwent transesophageal echocardiography with cardioversion in order to convert patient back to normal sinus rhythm. Patient also stated that she slept for an extra 4 hrs/day for several days following vaccination and developed a scaly rash on injection site. Patient currently admitted in ICU under close monitoring.

Three weeks after my vaccine shot I was dx with bilateral pulmonary embolism; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 13Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. None Known allergies. Patient was not pregnant. No other vaccine in four weeks. Historical vaccine included BNT162B2 (product=COVID 19, brand=Pfizer, lot number=EL9261) first dose administered in Left arm on 23Jan2021 01:15 PM. The patient experienced three weeks after her vaccine shot she was dx with bilateral pulmonary embolism on 16Mar2021 06:00 AM with outcome of not recovered. The event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Prolongation of existing hospitalization (vaccine received during existing hospitalization), Life threatening illness (immediate risk of death from the event). The patient was hospitalized for the event for 4 days. The patient's hospitalization was prolonged as a result of this event. The patient underwent lab tests which included Nasal Swab (sars-cov-2 test): negative on 17Mar2021. No covid prior vaccination. The treatment received included anti-coagulative therapy.

on 3-11-2021 pt presented to PCP and reported onset around the last week of February 2021. PCP directed pt to ED for urgent evaluation pt was hospitalized x 2 day, treated and sent home on Eliquis.

4:30pm slight nausea; arm pain; mild headache 5:00 pm headache more severe; up the back of head, described as unusual pain; thought a migraine was coming on. 5-7:00pm headache continues to worsen; chills; research on line side effects of Pfizer vaccine and they coincide with symptoms; 7:05 gets up to urinate (no assistance needed); screams out in pain 3 times while on toilet; starts to vomit; right side of face (eye and cheek and mouth droop like a stroke; left hand starts to curl. Loses consciousness immediately thereafter. 911 call; paramedics on the way; airway was swept and clear; gurgled breathing. Rushed to Hospital and assessed as having massive brain bleed. Pronounced dead at 10:22pm. Acute Hemorrhagic Stroke on Death Certificate.

Tiredness; Headaches; Chills; Fever; Nauseated; Dizziness; Weakness; felt sick; can't see as good, her eyes are weak; Difficulty breathing; thought she was having a heart attack; dehydrated; fast heart beat that felt like her chest was full; fast heart beat that felt like her chest was full; Injection Site Pain; blood pressure fluctuated; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 27Feb2021 12:00 (lot number: EN6202; expiration date: 30Jun2021) as single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure and stroke from 2012 to an unknown date. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN) taken for stroke from 2012 and ongoing; clopidogrel bisulfate (CLOPIDA) and simvastatin both taken for high blood pressure from 2012 and ongoing; ongoing amlodipine, lisinopril, and metoprolol all taken for high blood pressure. On 27Feb2021, she took the first vaccine. From that day, for 2 days, she had injection site pain. On 07Mar2021, she started having tiredness, headaches, chills, fever, felt nauseated, had a fast heart beat that felt like her chest was full and thought she was having a heart attack, dizziness, weakness, felt sick, and difficulty breathing. The patient added that she can't see as good, her eyes are weak. She was going to make an appointment to get her eyes checked. For dizziness event, she has to sit on the side of her bed for 10 minutes and she was still dizzy. She has to hold on to something because she feels like she is going to fall. She was given meclizine three times a day for this event. For tiredness event, she stated that it fluctuates during day. After she takes a paracetamol (EXTRA STRENGTH TYLENOL) and lays down for a while, she feels ok and then she feels tired again. For fast heart beat that felt like her chest was full and thought she was having a heart attack event, it comes and goes, she had it yesterday (21Mar2021) but hasn't had it today (22Mar2021) but she doesn't know if it is gone. Her symptoms were usually in the morning when she first gets up. She has been to the emergency room (ER) on 07Mar2021 and on 13Mar2021 and they say that nothing is wrong. On 07Mar2021, they gave her an IV because they thought she was dehydrated. On 13Mar2021, she went back to another hospital ER. She felt worse and her son came and got her and took her to the ER. They did a whole workup MRI of her head, x rays, blood work and everything. They didn't know what was causing it because it had it been over a week since her vaccine and they sent her home. She has been laying down and staying hydrated. She couldn't hardly get up and they asked her what has she done different and the only thing different was the vaccine. Everything listed on the risk factors [side effects] is how she is feeling. She was not hospitalized, they gave her medicine and told her to stay hydrated and sent her home and was told to follow up with her physician. She finally got an appointment for tomorrow (23Mar2021) with her physician. She can't drive because of the dizziness. All of her tests came back normal. They said her blood pressure fluctuated on 2021 but that is normal. Outcome of the injection site pain was recovered on 01Mar2021, of the difficulty breathing was recovering, of the headache, chills, fever, dizziness, weakness, and felt sick was not recovered, while of the remaining events was unknown.

died/cancer; collapsed on the floor; eyes rolled back; stopped breathing for a very short.; This is a spontaneous report from a contactable consumer. A 70-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: en6100, expiry date not reported), via an unspecified route of administration, administered in right arm Right on 06Mar2021 11:00 at a single dose for covid-19 immunization.Medical history included stage 4 esophagis cancer and mushroom allergies (known allergies to mushrooms). The patient had no covid prior vaccination; not diagnosed with COVID-19. The patient had other medications (unspecified) that the patient received within 2 weeks of vaccination. The most COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (lot number: el9267) for covid-19 immunisation in the right arm on 13Feb2021. The patient was not tested for covid post vaccination. Since the vaccination, the patient has not been tested for COVID-19. On the afternoon of 06Mar2021 (16:00), patient collapsed on the floor, eyes rolled back, stopped breathing for a very short. The patient was revived and carried to bed. She died at 4 am on the 13Mar2021. She told the reporter she did not want to go to the hospital and she said she wanted to die at home. The reporter stated that the cause of death was cancer since an unknown date. The events were reported as serious resulting in death. No treatment received for the adverse events reported. The patient died on 13Mar2021. The causes of death were cancer, collapsed on the floor, eyes rolled back, and stopped breathing for a very short. An autopsy was not performed.; Reported Cause(s) of Death: collapsed on the floor; eyes rolled back; stopped breathing for a very short; died/cancer

heart palpitations and a rapid irregular pulse. Per pulse oximeter, heart rate was 133 beats/minute. In the emergency room an electrocardiogram showed atrial fibrillation; This is a spontaneous report from a non-contactable consumer (patient). A 70-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 07:45 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. Medical history included allergies to medications of Clindamycin, Penicillin, Amoxicillin, Statins and hypertension (controlled on medication), type 2 diabetes (diet controlled), obesity, obstructive sleep apnea, thyroid nodules benign. Concomitant medication(s) included metoprolol (METOPROLOL), fosinopril (FOSINOPRIL, furosemide (LASIX [FUROSEMIDE]), niacin (NIACIN) and bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 07:45 (Batch/Lot Number: EN5318) as single dose for covid-19 immunisation. On 20Mar2021 18:00, the patient started to have heart palpitations and a rapid irregular pulse. Per pulse oximeter, heart rate was 133 beats/minute. In the emergency room an electrocardiogram showed atrial fibrillation. Cardiac, thyroid and all other labs were normal. Atrial fibrillation resolved in the emergency room without treatment. Discharged to home, appointment in clinic on 23Mar2021 with a cardiologist, who ordered Cartia XT (started 23Mar2021) and Eliquis (started 23Mar2021 after stress test). On 24Mar2021 a cardiac echo and a myocardial profusion imaging stress test were completed and results on both tests were reported as being normal. There was no past diagnosis of atrial fibrillation or of the above symptoms of heart palpitations and rapid irregular heartbeat. The symptoms have not been experienced since the initial episode on 20Mar2021. Plans are to remain on Cardia XT and Eliquis, and to be seen on 23Jun2021 in the cardiology clinic for an electrocardiogram and an appointment with the cardiologist. Therapeutic measures (Cartia XT 120mg per day, Eliquis 5mg two times a day) were taken as a result of the event. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unknown date in Mar2021 the event was recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

Immediate headache, heart racing, weakness, chest sensations, palpitations, nausea, After two weeks of continued symptoms suddenly had Afib with RVR event and went to Er