Pfizer

Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice with persistent wheezy cough after 5 min Progressed to itchy/burning/red face/chest/ears after 10 min. Wheeled to the emergency department 20-25 minutes after injection. Had to have benadryl, solumedrol, pepcid, zofran, and an epinephrine injection to stop the anaphylaxic reaction.

Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observation period after vaccine administration. A Rapid Response (RR) code for an anaphylactic reaction was activated. Vital signs were SPO2 100%, HR106 BPM and BP 150/100 mmHg. Patient received Epinephrine 0.3mg IM, Benadryl 50mg IV and Solucortef 200mg IV by RR code protocol. She was transfer to the ER. After transfer vital sings were 146/106 mmHg, HR 145 BPM and 120 BPM, RR 22, O2 sat 100% and 99%.

Pt was 18 weeks pregnant at the time of the vaccine. Second pregnancy. Pt is a physician. Pregnancy was entirely normal up to that time. On 1/18/2021, she began to have heavy vaginal bleeding probably due to a placental abruption and subsequently delivered at 18 weeks. Baby was stillborn. Ultrasound done 1/15/2021 normal. Lethal event for the fetus. The patient did well.

After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EPI pen was administered and emergency response team called. She was transported to the Emergency Room for treatment. She was treated with steroids and antihistamines. Diagnosed with anaphylactic reaction. Discharged with EpiPen, albuterol inhaler prn, and steroid taper.

December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Monday at work. I needed to use my inhaler twice that day. I couldn't stop coughing at work. At home that night - used inhaler again and I had an elevated temperature - 99. something is high for me. I missed work on Tuesday. Couldn't breathe and it hurt my chest to breathe. My temp was over 100. Dr appt - went to it late afternoon he wanted me test for COVID. Took vitals - mostly normal - temp.; checked OXYGEN - normal. COVID test - was positive. Temperature went to 101 that night - couldn't breathe good - couldn't stop shaking; I was aching and I was in pain; I couldn't feel warm enough. Tried to sleep and drink fluids. Still didn't have test results from COVID test on Thursday - temp was up to 102 now. The doctor said they couldn't do anything until they had results back of test. Friday - 101 and 102.8 - temperature that day. After hours clinic - I called them - Dr - I had to gasp for every breath and I was coughing a lot. He prescribed Benzymidate - cough pearls and Azithromycin - started taking those that night. By Sunday afternoon, my fever continued and I still didn't have COVID results yet. My mom took me to Urgent Care on Sunday - still running fever; he looked at my lungs and listened - he could hear wheezing and crackling in my lungs - he determined pneumonia - he didn't know what kind - he gave me Augmentin - he told me to use both my Albuterol inhaler and steriod haler; Mucinex expectorant twice a day; Vit C and Vit D and Elderberry and Tylenol and two antibiotics. Saturday - before I went to Urgent Care on Sunday - I noticed I couldn't smell. Monday is when I got the positive test for COVID. Provided info to work and I tried to figure out how to work. Even though I was still very sick, I worked again online on Monday. But I couldn't keep working - got really whoozy; coughing and gasping felt like I was going to pass out and felt like I could hardly breathe. My mom called 911 for me. I managed to get to the bathroom - but having trouble breathing and I almost threw up - heard ringing in my ears and room was spinning. There is a lot of things after that I don't remember - when they moved me to ambulance to hospital bed I realized I had an IV in me. They stabilized me. They let me go home. I took the rest of the week off from work. Took a lot of medication and was keeping up with my vital during that week - 99.8 - 102.8 - for ten days I ran that fever. Broke Jan 20th. I went back to work on Jan 25. Still had to use an inhaler a lot. I'm slowly getting taste back; I can't taste flavor but can taste salt . I'm slowly getting smell back. I still have a lot of congestion but not as bad. Ears were bothering me this weekend so I did go to urgent care on they put me on a third antibiotic for an ear infection. Gave COVID to my son and my mother. Still have trouble catching me breath. January 23 - my isolation was extended to . the county extended my isolation period because of my family getting COVID. I'm about 75% recovered, I'd say.

Headache, nausea, vomiting, sore arm, temp 102.8, chills began 1/08/2021 @ 9pm and lasted for 24 hours The next menstrual cycle was very heavy period, soaking heavy flow tampons every hour, large clots, and lasted 6 days from a typical mild flow 3 day period

Headache lasting greater than 1 week, extreme fatigue and vaginal bleeding. Normally no headaches and very regular cycle

I was about 9 weeks pregnant with no complications at the time of my second vaccination. Estimated due date was 08/24/2021. I began bleeding and cramping and having headaches approximately 10 days after my second dose. I sought medical attention and was told that my baby no longer had a heart beat and that growth (based on ultrasound) had stopped around the 9 week mark. I had medical assistance to physically miscarry the deceased fetus. I have one healthy living son (2 years, 4 months old) who was delivered without complications naturally.

1:39 PM - Vaccine administered 1:40PM - Anaphylactic reaction began (difficulty breathing) 1:40PM - First dose epinephrine administered with patient supply 1:45PM - Second dose epinephrine administered with patient supply 1:50PM - Third dose epinephrine administered with patient supply, EMS arrived, nasal cannula oxygen started 1:55PM - Fourth (PARTIAL... EMS did not remove locking mechanism, not certain how much patient received) dose epinephrine administered with store supply by EMS 2:00PM - Transported by EMS to Emergency Dept.

My first dose was 1/14. I found out I was pregnant on 1/26/21 and I miscarried at about 10 weeks. About 15 mins after I got the vaccine, I had a racing heartrate and my palms were hot, but it went away. Around 3pm, I had a right frontal headache. I took a nap and it went away. About 5am Fri, I woke up to severe arm pain and it felt like I was being stabbed in the stomach. I took about 400mg of Ibuprofen, went to sleep and was fine when I woke up. About 5pm Friday, I began having vaginal bleeding. I called my doctor and was able to get in on Feb 11th. At my OB/GYN appointment, they tested my blood and urine, which confirmed my pregnancy. The NP examined me and told me that the bleeding was coming from my cervix, so they sent me for an ultrasound the following week. That's when I was given my calculated date of 10 weeks. A gestational sac was observed, but they weren't sure if a fetus was present. I had to see my doctor every week since I was still bleeding and that continued until March 18th, when I lost the pregnancy completely. I took my specimen to the doctor the following day. They told me that they were sending it out to be tested, but I'm not sure if the results are back. They did confirm that it was a fetus.

Anaphylactic shock. Tongue, Hands and feet swelling. Hives all over body, skin felt like it was burning from itching so bad. Inside of mouth and throat itching. Chest felt like someone was sitting on it.

Signs/Symptoms: severe dyspnea, wheezing, anaphylaxis Treatment: Epi Pen (Left Anterior Thigh) and EMT Called/Transported to Hospital Emergency Department.

Experienced brief, minor dizziness about 10 minutes after the shot. On my drive home about 15-20 min. after the shot, I experienced more severe symptoms of anaphylaxis. I was able to breathe but my airway was constricted and swollen. After arriving home, I called pharmacy but their pharmacists were out on lunch. My primary care doctor was closed (Good Friday). I waited until the pharmacist was back from lunch and they advised Benadryl (I took 50 g at 2pm) and to have someone with me for the next 24 hours. Symptoms improved some but by 5pm I still couldn't take a deep breath normally and was concerned about eating food. I went to the ER where they admitted me and administered Pepcid and dexamethasone at 6:22pm. After about an hour and a half, I felt better and was released. Once home, I ate food and that irritated my throat again so I kept an EpiPen nearby that evening just in case. The next morning I felt 100% with no side effects.

I start seeing blood spots with passing tissues since then. no pain or any feeling. just slight bleeding. Called the doctors. they are monitoring

The next morning after I had arm pain and was very fatigued which lasted about a week. On 2/27 I started experiencing on and off vaginal bleeding but drs had no treatment they could provide. I was diagnosed with a threathened miscarrage and on 3/22/2021 I miscarried. EDD-11/7/2021. There were several bouts of bloodwork perfomed which were normal until the miscarrage occurred and all ultrasounds were normal until the 3rd which showed the miscarriage.

Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactions: facial swelling, lips swelling, reddness, small hives. Patient was given 25mg Benadryl PO per protocol. Dr was made aware. Monitored patient. Patient started to experience some throat tightness but no shortness of breath or difficulty breathing. Spoke with Dr again and gave patient 0.3mg Epinephrine in right deltoid. Dr came down to clinic as patient was going to ED per car with her sister driving. In the ED , patient was treated for anaphylaxis at hospital and stayed overnight (epinephrine, solumedrol, pepcid x2). After discharge on prednisone 40mg daily x5 days, patient came back with hives and was readmitted and treated overnight with pepcid/benadryl expect to be discharged again today.

Approximately 11 days s/p 2nd vaccination, patient developed calf pain. After the pain persisted for two days she went to the local emergency room and was diagnosed with a DVT. No personal or family history of blood clots. No precipitating life events. No culprit medications. Age appropriate cancer screening up to date.

Repeated, extreme nosebleed with large clots. I was unable to stop it and had to go to the ER on 4/16. They had to cauterize the site of the bleed. I do have a history of mild nosebleeds but this was unusual. I do not take any blood thinning medications. The silver nitrate did stop the bleeding. The ER ductus was not concerned that this was vaccine related but I thought it was unusual enough to report.

Nausea, vomting, palpitations starting 10 minutes after vaccine administration. Generalized Tonic Seizure 2 days after vaccine. CT head negative in ED, discharged 8 days after vaccine, presented to clinic with continued daily seizure like activity, inability to stand due to leg shaking. Exam notable for Lower extremity myoclonus. Then, admitted to hospital on 4/8. MRI brain unremarkable. EEG with potential epileptiform activity. Patient discharged on 4/10 on keppra for seizure prophylaxis, Home health physical therapy and neurology follow up.

Pt went to the ER on 4/19/21 with vaginal bleeding and cramping at approx. 6 wks gestation per LMP. HCG >7,000 on 4/19/21. Presented to clinic on 4/22/21 with chills, nausea, vaginal bleeding, sent for u/s, no IUP seen, HCG today 500.

Headache, confusion, muscle and joint pain, inflammation, fatigue, etc etc. Including LUPUS FLARE- aggravated Systemic Lupus- which still continues 2 months later.. Also, developed DVT?s in both arms- previously dx.ed with APS- Antiphospholipid Syndrome and was already on anticoagulant therapy. Possible clot in/near artificial heart valve- further testing being done next week. After 2nd dose Also increase in Lupus Flare, as well as severe Fibromyalgia Flare- aggravated FMS. Extreme muscular pain/neurological pain, confusion, fatigue, etc etc.

I got my period on April 1, and in 30 years of menstruating, it was the worst period I've ever had. I bled for 16 days straight with no let up, went through two boxes of super plus tampons and a bag of extra long pads (I normally bleed for 5-6 days with only one heavy day, use a mix of super and regular tampons, about 15-20 total). I passed large blood clots almost every day of this long period (never happened for me before).

anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed to swollen lips, tongue; cough; throat irritation; wheezing; This is a spontaneous report from a contactable consumer (patient). The 40-year-old non pregnant female patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, lot number: EW0150 expiry date unknown) via an unspecified route of administration on Left arm as a single dose on 06Apr2021 09:30 AM. Medical history included asthma, known allergies: Biaxin, albuterol, xopenex, apples, pears, stone fruit (peaches, plums, apricot, etc), almond, hazel-nut. Concomitant medications included Zyrtec, Nasonex, Flovent, Singulair and Zoloft. On 06Apr2021 10:00 AM, started with rash/hives on face, then progressed to swollen lips, tongue, cough, throat irritation/swelling and wheezing. Initially treated in emergency room (ER) for anaphylaxis then released. Within 30 minutes, symptoms returned and was treated ER for anaphylaxis and was admitted for observation. She was discharged in the morning of 07Apr2021, but had to return to ER that evening, and was discharged in the morning of 09Apr2021. She was treated with Epinephrine, Benadryl, steroids and Pepcid. She did not receive any other vaccine in four weeks prior to the suspect. The patient was not suffering from covid prior vaccination. On 06Apr2021, she was tested through Nasal Swab for Covid and results were found to be negative. The outcome of events was recovering. No further information was available.

Patient had a CT head without contrast that demonstrated hypodensity within left MCA territory. CT head/neck no findings to elucidate etiology of stroke. There is loss of flow in the V3 segment of the left vertebral artery with no reconstitution of flow distally. MRI brain without contrast with left MCA subacute ischemic stroke. Echocardiogram with no cardioembolic source. 7 weeks pregnant

First dose given 03/17/2021: momentary adverse reaction: racing heartbeat. Second dose given: 04/08/2021: no immediate adverse reaction other than soreness at injection site & general feeling of unwellness. Days after, tingling in the fingers…until the 17th, rib and back pain began. Pain radiated and worsened over the next two days. Was seen by PCM 04/20/2021, sent for XRAY, CAT scan, and ER, immediate diagnosis of Pulmonary Embolism in the right lung, as well as lung infarct in lower portion.

Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred vision/blurry eye (right); right arm/leg weakness; This is a spontaneous report from a contactable consumer (the patient). A 40-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown due to it was never shown vial, just administered injection by nurse) via an unspecified route of administration in left arm on 16Apr2021 18:00 at age of 40-year-old at single dose for COVID-19 immunisation. Relevant medical history was "none". No known allergies. Concomitant medications included levocabastine hydrochloride (ZYRTEC) taken for an unspecified indication from an unspecified date, and multivitamin. The patient did not take other vaccine in four weeks. No COVID prior vaccination. COVID not tested post vaccination. The patient experienced Possible TIA (diagnosed in Urgent Care), loss of balance, dizziness, headaches, neck pain, blurred vision, right arm/leg weakness, blurry eye (right). The events onset date was provided as "18Apr2021 10:00 a.m.". The events 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). No treatment received for the events. The outcome of the events was not recovered. Information about lot/batch number has been requested.

1/28 1st Pfizer > 1/29 Onset, dizziness, nausea, h/a, eye pressure, "heaviness" in legs, altered taste 2/3 Cough, mild congestion Seen in ER on 2/5 for evaluation of cough. Reports 3 days of upper respiratory congestion, mild nonproductive cough. Diffuse body aches. Mild nausea associated with coughing, however no emesis. Denies chest pain/abdominal pain. ROS positive for: fatigue, congestion, cough, myalgias.

Headache stomach issues and arm pain Thursday chest pain and shortness of breathe went to the er had blood clots

more than usual vaginal bleeding/with very dark blood with clots.; menstrual cramps; sharp pelvic pain; more than usual vaginal bleeding; more than usual vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 10:30 (Batch/Lot Number: ER8734) as single dose for covid-19 immunisation. Facility type Vaccine: Other. Medical history included known allergies: Sulfa and Folate deficiency. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6206) on 15Mar2021 10:30 AM in left arm for covid-19 immunisation and experienced vaginal bleeding/blood clots at mid-cycle on 15Mar2021 08:00 PM. If other vaccine in four weeks: No. Other medications in two weeks: No. If Covid prior vaccination: No. If Covid tested post vaccination: No. The patient experienced more than usual vaginal bleeding/with very dark blood with clots, menstrual cramps, sharp pelvic pain, all on Apr2021 with outcome of not recovered. Clinical course: After the first dose, the patient had vaginal bleeding/blood clots at mid-cycle. The same day after the 2nd dose, she started feeling menstrual cramps and sharp pelvic pain. After taking paracetamol (TYLENOL) and feeling a bit of relief, she stood up and started having more than usual vaginal bleeding at the level that it reached the floor as if it was a hemorrhage with very dark blood with clots. This lasted for 1 minute. This lasted for 5 days and 7 days later, she started bleeding again with dark blood clots for a period of 3 days. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for events more than usual vaginal bleeding/with very dark blood with clots.

vaginal bleeding/blood clots at mid-cycle; vaginal bleeding/blood clots at mid-cycle; vaginal bleeding/blood clots at mid-cycle; This is a spontaneous report from a contactable consumer. A 40-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6206, via an unspecified route of administration, administered in left arm on 15Mar2021 10:30 as single dose for Covid-19 immunisation. Medical history included folate deficiency and allergies to sulfa. There were no concomitant medications. After the first dose on 15Mar2021, the patient had vaginal bleeding/blood clots at mid-cycle. No treatment information was provided. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association reported events causal relationship with BNT162B2 cannot be excluded. Case to be re-assessed upon receipt of new information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Irregular menstrual cycle--18 days instead of usual 28 days, and bleeding occurred exactly 1 week from each of the two doses.

blood clots in left lung which turned into an infarction; blood clots in left lung which turned into an infarction; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration, administered on the left arm on 15Jan2021 (at the age of 40-year-old) at a single dose for COVID-19 immunisation. Medical history included lupus. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]). The patient had blood clots in left lung which turned into an infarction on 22Feb2021. The event resulted in a 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). The patient was hospitalized for the events for 3 days. Therapeutic measures were taken as a result of the events which included blood thinners and anti-inflammatory meds. COVID test post vaccination on 03Mar2021 Nasal Swab: Negative. Patient was not pregnant. 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. Outcome of the events was recovering.; Sender's Comments: Drug causality would seem unlikely fo rBNT162B2 since there is no plausible mechanism implicating the subject drug to the events. The case will be reassessed should additional information become 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 received 2 doses of Covid-19 vaccine. First dose on 3/20/21 and 2nd dose on 04/10/21 Adverse event: 04/16/21 (Stroke) and was subsequently admitted to our facility for inpatient rehabilitation after initial admission to an acute care facility.

PATIENT HAD SHORTNESS OF BREATH FOR THE PAST 2-3 WEEKS DIAGNOSED WITH PULMONARY EMBOLISM AND PLEURAL EFFUSION

Placental abruption (with heavy bleeding) occurred two days short of week 36 in first pregnancy (which was achieved via IVF with PGS-tested embryo), resulting in stillbirth on 5/6/2021; baby was 4lb 8oz upon delivery. Due date was June 4, 2021.

Found out I was pregnant day after shot week later I was bleeding for 3 days kind of like a period then it stopped on the 25 I started having high fevers chills facial flushing went to walk in clinic on 27 said I have strep throat took antibiotics 5 days in still having fever chills flushing went to primary dr did blood work showed I had infection blood pressure started becoming high went to obgyn pregnancy hormone low was told not a good pregnancy on 5/14 went to have pregnancy terminated blood pressure very high on 5/17 back at primary dr with high fever chills facial flushing again blood pressure still high put on a water pill to control blood pressure went back to obgyn everything good from procedure hormone levels almost back to zero

I was 7 weeks pregnant and received 2nd Pfizer vaccine, on the same day started having virginal bleeding and crumping, had miscarriage next day.

Right after vaccine injection site was extremely itchy. After a few minutes of vaccine my whole body was itchy . Left arm was extremely sore warm to touch and bruised 45 minutes after vaccine I bleed as if I was getting my period (Bright red blood) spotted until the next day then it was done. I was due for my menstrual cycle on 05/22/2021 which never came I am regular on my cycle. Topical rash on neck developed after 24hrs , redness, itching and burning

Two weeks after the first Pfizer shot, I experienced labored breathing, congestion, fluid around my heart and left side numbness and stabbing head pain.

On 5/28/2021 I started to develop shortness of breath. It continued to worsen and I went to the hospital on 5/30/2021 and it was discovered that I had a pulmonary embolism and after additional ultrasounds 3 DVT blood clots in my right leg.

anaphylactic shock (fully body hives/extreme swelling of faces, neck, and limbs/ full body rash/painful itching/ feeling like a very intense burn) has lasted for 5 days causing hospitalization (has not gone away yet)

AFTER THE FIRST VACCINE: HERPES BASED BLISTERS IN MOUTH TO THE POINT THAT TAKING OR EATING WAS VERY PAINFUL. SAW MY PA ON 03/25/21. VALTREX PRESCRIBED. BLISTERS WERE MUCH BETTER WITHIN 48HOURS. 03/27/21 UNEXPECTEDLY HAD MY PERIOD. I HAD JUST FINISHED UP MY PERIOD WHEN I HAD THE VACCINE ON 03/18/21. THIS PERIOD WAS UNLIKE ANY OTHER. THE BLEEDING WAS INCREDIBLY HEAVY, FULL OF CLOTS AND LASTED 9 DAYS. MY USUAL CYCLE IS 5. AFTER SECOND DOSE: ANOTHER UNEXPECTED PERIOD. THIS TIME NOT AS HEAVY, NOT AS MANY CLOTS AND DID NOT LAST AS LONG. SORE UNDERNEATH ARM AND LYMPH NODE UNDER ARM SWELLED.

blood disorder; hypercoaguability; Pulmonary embolism; pulmonary infarct; This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Lot number: ER8729) in left arm on 08Apr2021 15:30 at age of 40-years-old at single dose for COVID-19 immunization. Medical history included Known allergies: Sulfa and Morphine. Prior to vaccination, the patient was not diagnosed with COVID-19. Not pregnant at time of vaccination. Concomitant medications included patient received within 2 weeks of vaccination included: cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE), over the counter multivitamin. Patient previously received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Lot/batch no.: EP7534) in left arm on 17Mar2021 13:30 at age of 40 years old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Diagnosed with pulmonary embolism and infarct as well as blood disorder-hypercoaguability on 20Apr2021. Event start date was on 17Apr2021 14:30. 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), Disability or permanent damage. Serious report. Since the vaccination, the patient had been tested for COVID-19. COVID test post vaccination: Nasal Swab on 20Apr2021: Negative. Patient received treatment for events included rivaroxaban (XARELTO). Outcome of event was not recovered. Information about lot/batch number has been obtained.

Sharp pain in left leg toe for 30 minutes then a bumpy feeling. Next day morning showed up a bruise kind of spot (blood clot). No numbness, itchiness or pain in that area.

Patient developed palpitations and dizziness two days after 2nd Pfizer COVID-19 dose (4/5/21) and then had sustained ventricular tachycardia requiring cardioversion 4 days later. Cardiac MRI was normal (no evidence of myocarditis). Underwent successful ablation of right ventricular outflow tract ventricular tachycardia on 4/12/21. Has been event free since. No history of palpitations or premature beats prior to vaccine. No family history of arrhythmias.

bleeds were difficult to stop (lasting 15 or more minutes) and with clots; severe nosebleeds; This is spontaneous report from received via health authorities from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 27Apr2021 05:15 pm (Batch/Lot Number: EW0170) as single dose for covid-19 immunisation. Patient is not pregnant. Medical history included hashimotos, von willenbrands type 1. And patient avoided gluten and dairy for autoimmune disease. Concomitant medication(s) included levothyroxine sodium (SYNTHYROID) and methylfolate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Brand synthroid 200 mcg, multivitamin, l-methylfol. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ER8734) administered in right arm on 06Apr2021 06:00 pm for covid-19 immunisation. About 36 to 48 hours after receiving dose number 2 for the covid pfizer vaccine, patient began to have recurring severe nosebleeds on 29Apr2021 16:00. The bleeds were difficult to stop (lasting 15 or more minutes) and with clots. These lasted daily for 3 to 4 days and then ceased completely. Patient met virtually with hematologist, and he encouraged repeat PTT/PT bloodwork and visit to ENT. Met with doctor, ENT. There were no structural issues in the nose and bloodwork came back normal, so both concluded that vaccine may be cause of bleeds. The adverse events result in doctor or other healthcare professional office/clinic visit. Patient underwent hematology bloodwork, ENT exam. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The event outcome for events was recovered on unspecified date.

reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks; intense pain in reproductive organs; Bloating; now growths (possibly cervical polyps); dull achy sore pain where the shot was administered; tingliess in her fingers on that arm; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown, NDC 59267100002) via an unspecified route of administration at left arm on 13Apr2021 12:00 (40-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included depression and ADHD. Concomitant medications in two weeks included dextroamphetamine hydrochloride; alprazolam; sertraline hydrochloride (ZOLOFT); hydroxyzine hydrochloride (VISTARIL). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 23Mar2021 11:00 (40-year-old at time of vaccination) for COVID-19 immunization. Patient did not receive any other vaccines within 4weeks prior to the COVID vaccine. Event start date was reported as 14Apr2021 15:00. Patient has had a dull achy sore pain where the shot was administered ever since she received the last shot. She also has tingliess in her fingers on that arm. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for these adverse events. The patient also reported intense pain in reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks. Bloating and now growths (possibly cervical polyps)- visting OBGYN for follow up. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The case was serious, medically significant. No therapeutic measures were taken as a result of the event "dull achy sore pain where the shot was administered" and "tingliess in her fingers on that arm". The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient was approximated 10 weeks pregnant and received her second dose of the Pfizer vaccine on 6/16. Four hours later, she began cramping and spotting. This worsened over 3 days. She began hemorrhaging hours prior to her ER visit . She was hypotensive and required an urgent suction curettage

feminine blood spotting starting about 4 days pos 2nd injection. Early menstruation cycle start leading to continuous spotting between cycles. Periods are irregularly heavy and consist of tissue and clotting materials. Cramping leading to bed rest requiring medication and heat.

Sudden Cardiac Arrest, needed to be defibrillated twice. Life support for 2 days. No previous health issues. Hospital stay for 7 days. ICD implanted.

she was hospitalized for 4 days and treated for ITP.; nose bleed; Caller states she gave birth to her son 28DEC2020, and she had been exclusively breastfeeding; Caller states she gave birth to her son 28DEC2020, and she had been exclusively breastfeeding; they did a blood count and sent her to the ER because her platelets were 5 or 7, they were low; This is a spontaneous report from a contactable consumer or other non hcp. A 40-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Left arm on 13Apr2021 10:30 (At the age 40-years-old) as single dose for covid-19 immunisation. Medical history included covid-19 from Mar2020 to an unknown date. Family Medical History Relevant to AE(s): None, all have had the Moderna vaccine and no adverse reactions besides fever and pain in the arm but nothing like this. The patient's concomitant medications were not reported. On 10Apr2021 the patient experienced she was hospitalized for 4 days and treated for itp, nosebleed from 13 Apr 2021 to 16 Apr 2021, on 05Apr2021 states she gave birth to her son 28dec2020, and she had been exclusively breastfeeding, on 05Apr2021 they did a blood count and sent her to the er because her platelets were 5 or 7, they were low. The patient was hospitalized for nosebleed from 13Apr2021 to 16Apr2021. Caller states on 13APR2021, she had her second Pfizer Shot. Caller states that night she had a nose bleed so she went to the Urgent Care and they did a blood count and sent her to the ER because her platelets were 5 or 7, they were low. Caller states she was hospitalized for 4 days and treated for ITP. Caller states then she did one treatment for ITP and then she did a second treatment for ITP. Caller states she was hospitalized a couple of weeks later and given treatment. Caller states she is taking a 3rd treatment currently. Caller states her Platelets keep crashing down. Caller states she has blood work drawn every few days and she is being monitored closely to make sure her platelets don't drop too low. Caller states one treatment was given for over a month. Caller states she had 2 dexamethasone treatments, 2 IVIG treatments and now she is on Prednisone and doing a slow taper. Caller states if this doesn't work, they are going to explore other longer-term options. Caller states she has no history of autoimmune disorders or ITP. Caller states when she says ITP, it stands for Immune Thrombocytopenia, or it is also called something else, Idiopathic Thrombocytopenia. Caller states she went to the Urgent Care first for the nosebleed and petechiae and she didn't think anything was probably going on, but they did bloodwork and her platelets were really low so they sent her to the ER and she was admitted to the hospital from 13Apr2021-16Apr2021 for 4 Days. Caller states she was admitted to the hospital a second time 23Apr-26Apr2021 for 4 days. The patient underwent lab tests and procedures which included antibody test: positive, platelet count: 5-7 low on 13Apr2021. Other Conditions tested Positive Antibody IVG Spike Protein and Nucleocapsid; states result from antibody test indicate that she has probably had Covid sometime in the past, only time would have been March 2020 when the pandemic started, she had symptoms that weren't reported as symptoms yet and she was traveling in India at the time. States she doesn't know what strain it may have been. States she tested for antibodies because she was interested to see how the steroid was affecting her response to vaccine. Patient was healthy before vaccination with no allergies. Outcome for the event immune thrombocytopenia, maternal exposure during breast feeding, off label use was unknown, event nosebleed was recovered, event blood count abnormal not recovered. Information on Lot/Batch has been requested.

My heart stopped; This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received bnt162b2, second single dose via an unspecified route of administration, administered in arm right on 06Apr2021 (Batch/Lot number was not reported) for covid-19 immunisation at age of 40-year-old. Medical history was none. The patient had first dose of bnt162b2 on 06Mar2021 at right arm at age of 40-year-old. Concomitant medication in two weeks included omeprazole (PRILOSEC). No other vaccine took in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient heart stopped on 10Apr2021and she died at home, her husband brought her back to life, then she died in the ambulance they brought her back to life. Then in the Hospital trauma room they sent her to CT scan she died again for 5 minutes they saved her again. The patient was admitted for 6 days and received treatment for the event. The event resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was recovered with lasting effects. Information regarding the Lot/Batch number has been requested.

Heart started racing/palpating, glanced at clock- 12:23PM roughly 30 minutes after getting the vaccine. less than a minute later I lost my hearing in both ears, throat started to close and started to wheeze/gasp for air. Started to pull over to right shoulder of hwy and call EMS 12:25 could not breathe at all and began to panic having small child in back seat. dialed EMS but cannot breathe at all. 12:26 blowing cold ac in my face and finally caught a small breath. Slowly felt throat loosen a little and began gasping for air. 12:28 sweating profusely, able to breathe, still cannot hear anything out of left ear, regained hearing in right ear. Chest is tight and hurts, severe headache, lump in throat feeling. 12:30 I decide against 911 and drive home. Stayed in bed with family home. Still no hearing in left ear, chest pain, tightness in chest, heart palpitations.

On June 10th I began to have chest pain. It was very bad so I went to the ER. 10 minutes after arriving I coded and had to have CPR and shock my heart back. I was airlifted to Hospital where they placed a stent in my LAD due to 100% blockage. No other blockage was found in any other artery. I spent two more days in the hospital and have have been recovering at home.

Symptoms Shot January 10 Sore arm Fever headache cough 7 days Brain fog persistent headaches No period February lymph nodes under the armpit 3 days Persistent headaches No period March Persistent headaches No period One day of blood clots Er visit for upper gi severe pain ct clear April Headaches worsening No period May Headaches worsening No period Tremors in right hand ER VISIT migraine meds given no change June Headaches worsening No Period Stuttering and speech difficulty 6 10 15 16 dizziness and vomiting 6 10 difficult with walking Pain behind eyes moving side to side and up and down 6/19 carbonated sodas are flat can?t feel Carbonation in my mouth July Worsening head pain Consistent stutter Intermittent problems with walking July 5th hard time gripping items and equilibrium off. Treatments. EEG shows diffuse brain dysfunction, VERS shows optic nerve information. Intercranial pressure increased. No changes still testing

Monthly cycle has been heavy bleeding, defibrilating cramps, and unpredictable. Spotting moments after the vaccine. Chest pain, and pins and needle sensation in legs.

DVT left saphenous vein and left common femoral vein. Redness and tenderness inside of left thigh x 2 days. Got an ultrasound 1/29/21 that confirmed DVT. Treatment: eliquis x 3 months and for as long as I'm on tamoxifen. If discontinuing tamoxifen, daily aspirin recommended.

Patient returned for her second Pfizer Covid vaccine on 7/20/21 and stated that she had been treated for a blood clot in her lung(s) on 7/12/21. She received her first Pfizer Covid vaccine on 6/29/21. Treatment for clot is ongoing

Contracted covid between doses of the vaccine, and had AFIB several months later in May (4 months after). Hospitalized, given IV cardizan, prescribed PRN cardizan, have not had to use it since, have not had another episode.

Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then itchy throat, probably about an hour, as that got worse throat started swelling. Took 50mg prednisone 2 benadryl and albuterol inhaler. Breathing got better and hives went away but still had swollen throat and took pepcid. Headache afterwards but that's typical of an allergic reaction. I can't be sure it was from the vaccine or not but nothing I did yesterday would normally trigger that reaction

Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nurse and at that time my watch was beeping afib.

Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightness in throat; symptoms lasted 0 days

About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongue and back of my throat. I waited to see if it would go away and then a couple minutes later noticed my lips started itching and swelling and from there it just got worse. I told the nurse practitioner that I think I was having a reaction, she had me take a seat told her my entire mouth throat & lips felt swollen and itching and she looked and said it was full blown anaphylaxis reaction. Administered EpiPen, benadryl and called ambulance where they took me to medial emergency department.

Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain that lasted a few days and started to notice small purpura rash on left breast. She didn't think much of it but noticed the same type of rash on her pant line and then right thigh. On 1/15 she called Occupational Health who advised her to go straight to the ED.

Anaphylactic reaction to COVID-19 booster (2nd shot) Refractive Asthma brought on due to anaphylaxis

Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe

Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and warm and observed blue/purple skin coloring on upper arm and lower arm was red. Went to ER on Feb 15th, and ultrasound revealed a blood clot near the junction of the subclavian vein and cephalic veins. Diagnosis was idiopathic subclavian deep vein thrombosis (DVT). Started on enoxaparin and warfarin on Feb 15th. Referred to hematology and coumadin clinic to monitor INR.

extreme muscle pain for 24 hrs . started immediately as minimal and increase to extreme within 3 hrs. face felt numb for about 20 minutes after receiving shot that lasted 15-20minutes. there was a tingling sensation present during the numbness in the center of my forehead. possibly related: experienced light nosebleed day after shot. three days after shot experienced a heavy nosebleed with very large clotting.

deep vein thrombosis in lower left leg; mild fever; fatigue; body aches all in the day following injection DVT persists and was diagnosed 6 days later; all other symptoms resolved within 24 hours

Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.

ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR TO COMMING FOR SECOND VACCINATION AT 1125 12:57 PT STATES S/S OF ANAPHYLACTIC REACTION, SCRATCHY THROAT, TONGUE SWELLING, HIVES, ITCHING VS TAKEN: HR 120,RR 20,BP 150/78, SPO2 100% RA 1258: EPI PEN GIVEN X 1 IM TO LEFT VASTUS LATERALIS, PT TOLERATED WELL. 1259: SQUAD AND ER NOTIFIED FOR NEED OF TRANSPORT TO CPH. 1301:DEXAMETHASONE10 MG IM IN RT LETOID GIVEN X 1, PT TOLERATED WELL. 1305: 20 GUAGE SL PLACED TO RT WRIST. PT TOLERATED WELL. 1315: REPEAT VS TAKEN AND STABLE HR 95, RR 20, BP 140/74, SPO2 100% RA. 1315 RESCUE ARRIVED AND TRANSFERED TO CPH

Developed ITP (Idiopathic Thrombocytopenia Pura); This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration Date not reported), via an unspecified route of administration on an unspecified date (at age of 41 years old, no pregnant) at a single dose for COVID-19 immunization. The patient medical history was not reported. There was no COVID prior vaccination and no COVID tested post vaccination. The patient's concomitant medications were not reported. The patient developed ITP (Idiopathic Thrombocytopenia Pura) on 23Feb2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment received dexamethasone. The outcome of the event was unknown. Information on the lot/batch number has been requested.

Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sensation of throat closure; Upper airway swelling/Increased use of accessory respiratory muscles; she could not breath/Difficulty breathing (without wheeze or stridor); Respiratory distress; her lips and tongue were big and it was getting worse; her lips and tongue were big and it was getting worse; Hoarse voice; Shock; Decreased level of consciousness; Generalized prickle sensation; Red and itchy eyes; Red and itchy eyes; Abdominal pain; The initial case was missing the following minimum criteria: adverse event (unspecified). Upon receipt of follow-up information on (17Mar2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm right on 25Feb2021 08:15 (Batch/Lot Number: EN6203) as SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included asthma. It was reported that the patient was allergic to NSAID, paracetamol (TYLENOL), pollen, cats and dogs; and insect bite/sting. She also had environmental allergies. It was also reported that her sister had breast cancer. Ongoing concomitant medications included spironolactone (SPIRONOLACTONE), vitamin C, cyanocobalamin (VITAMIN B12), calcium (CALCIUM), magnesium (MAGNESIUM), iron (IRON) and zinc (ZINC) all taken for unknown indications since unknown date. She had no other vaccines received around the time of COVID-19 vaccine vaccination. The patient was not pregnant (including at the time of vaccination). The patient received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 25Feb2021 at 08:15 AM. Thirty minutes after the vaccination (at 08:45), she had an anaphylactic reaction as she felt her heart going fast and was noted to have tachycardia (as an organ involvement), had sensation of throat closure her throat starting to close. She had upper airway swelling with increased use of accessory respiratory muscles, respiratory distress as she could not breath (without wheeze or stridor). Her lips and tongue were big and it was getting worse. She also had the following organ involvements manifested by hoarse voice, shock, decreased level of consciousness, generalized prickle sensation, red and itchy eyes, and abdominal pain. She was administered with diphenhydramine (BENADRYL) IV. She was taken to ER and was also administered with famotidine 20 mg. The events were considered life threatening. The patient recovered from the events on unknown date in 2021.

Anaphylactic Shock; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 41-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6203 and expiration date: Not available), via an unspecified route of administration in the right arm on 28Feb2021 at 12:00 PM as a single dose for COVID-19 immunisation. The patient was not pregnant. Medical history reported as None. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 28Feb2021 at 12:00 PM, the patient experienced Anaphylactic shock/allergic reaction. The patient received Epinephrine Injection for the events. The events resulted in a visit to emergency room/department or urgent care. The clinical outcome of events was recovered with sequel (with lasting effects). No follow-up attempts are possible. No further information is expected.

45 minutes after injection of Pfizer (dose 1) patient felt dizzy. Was brought back to nurse that administered vaccine. Red splotchy chest, red ears, still dizzy and nauseous. Was admitted to ER where patient had 200/120BP and 140 pulse. Patient diagnosed with anaphylactic response to covid19 vaccine.. Epinephrine administered. Pepsid AC, Prednisone, and IV fluids. Vitals normalized and patient discharted ~2 hours later and prescribed pepsid, prednisone, and anti-nausea medication.

Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild

Patient came to EC for suspected sepsis, fatigue, fever, and generalized body aches, recent chemo 6 days ago (4/7) with associated fatigue chills, admitted to observation for febrile neutropenia

Delivered preterm infant (stillbirth) at 24 weeks on March 9, 2021. Infant had IUGR noted at 19 weeks. Placenta showed 2 blood clots restricting blood flow at delivery. Mother with no known clotting disorders. 2 prior healthy infants.

Period-type vaginal bleeding. Dark blood. My last period was less than 2 weeks ago, so this is not a timely period.

Shortness of breath and chest pain 4/9/21 Went to ER on 4/9/21 Diagnosed with Multiple Pulmonary Embolisms in both lungs; transferred via ambulance as medical emergency to another hospital for treatment Released from hospital on 4/11/21 and currently under treatment

Superficial blood clots in both upper legs; each leg had one in the front and one in the back. They were very painful and tender with bruising around the area. The clots could be seen and felt.

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

Six days after my second shot of Pfizer I got a DVT Clot in my left leg behind the knee. Started with Severe pain felt like a charlie horse in my left calf and foot that would not go away for more than 24 hours. My Blood pressure spiked and i got a migraine from the pain , My left leg and food felt like stone.. The next day I called the nurse from my insurance company and she advised I go in to the hospital. Went to ER got a Ultrasound, blood tests and the ultrasound came back positive for a DVT clot. Treatment is Xarelto and follow up with my primary. Lab Results came back normal.

I tested positive for pregnancy on March 17, 2021. on March 24th I got my first dose of the Pfizer vaccine for COVID. On April 4, 2021 I had my first appointment with my OB / GYN. The doctor did an ultrasound and found that everything was fine with the baby. The baby was the right size and had a heartbeat. April 14th I got my second dose of Covid's vaccine. After an hour I started having cramps. Around 1:15 PM I had a bleed (light red). Around 2:00 pm I was seen at the doctor's office. She did a new ultrasound. The doctor said she couldn't find a heartbeat during the ultrasound exam and that I was having a miscarriege

Short Summary: DVT followed by Multiple Bilateral Pulmonary Embolisms (significant blood clots in both lungs). Context: After the first vaccine (about a week before my second vaccine), I self diagnosed myself with a calf injury due to extreme pain in my calf that felt like a continuous cramp. The extreme pain lasted until my second shot (about a week). When going for my second shot, I reported a rash with hives on my lower abdomen that had appeared within five hours of my first shot, so they requested I stay a little longer for observation. That night I began having some breathing difficulties, but assumed they were to be expected. The breathing difficulties continued to get worse until my nurse practitioner told me to go directly to the nearest ER (2/16/21), where I was officially diagnosed with multiple bilateral pulmonary embolisms. I was admitted to healthcare facility for 24-48 hours, until an EKG revealed heart abnormalities that caused them to use a physician's transport to move me to another unit. I was discharged from the hospital on 2/2/21 after I stabilized from heparin shots, avoiding more invasive procedures. I have been in ongoing recovery since then, receiving ongoing care from a hematologist and pulmonologist. A little extra context for you - I arrived to the hospital with diabetic ketoacidosis and have an endocrinologist since hospitalization that has diagnosed me with Type 1 Diabetes (previously misdiagnosed as type 2 - I'm now on insulin which is controlling my blood glucose well).

My heart went into A-fib and was racing for almost a week. Beating really really hard. I was traveling at the time and didn't have my llo recorder remote available to track symptoms but the same day I returned home, my doctor called me to tell me my heart was in A-fib (03/17/2021).

20 minutes after my second shot, I developed wheezing at the base of my throat. It did not escalate to full anaphylaxis but remained a steady wheezing feeling for a number of hours after. It dissipated be evening but returned 4 days later along with tingling in my lips that comes and goes. It continues on and off 2 weeks post vaccine. I do not have any other illnesses or reasons to think this other than a side effect from the vaccine. I do not have a history of asthma either.

Patient developed hives on their chest and bilateral arms and difficulty breathing with concerns for anaphylaxis. On examination in the ED, the patient was noted to have a urticarial rash, mild oropharyngeal swelling and erythema, inspiratory stridor. Patient was initiated on anaphylaxis therapy after RRT on arrival to resuscitation room, starting with 0.3 mg of IM epinephrine. Also provided 50 mg of Benadryl, 20 mg famotidine, 125 mg of Solu-Medrol. Lactated Ringer's infusion began, received 1L LR. Patient was discharged home after resolution of symptoms.

5 days after receiving my first vaccine, my heart went into Atrial Fibulation. That has never happened before. I was put into the hospital to get it back into normal rythm. I was 9 1/2 weeks pregnant when the incident occured. I do have some minor heart issues already known such as Mitral Valve Prolapse and a small PFO. However other than a flutter here and there the last 25 years of my life, I havent had any issues. It makes me wonder if the vaccine set it off.

The patient received the Pfizer COVID vaccine and did not have any apparent reaction initially. Sixteen days after vaccination, the patient developed pain in her neck and shortness of breath. ER evaluation revealed a DVT in her right brachiocephalic vein and acute pulmonary embolism.

Grand mal seizure; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 23Mar2021 at 08:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and Tourette's syndrome from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162B2 on 23Feb2021 at 10:30 A.M. (at the age of 41-years-old), administered in right arm for COVID-19 immunisation. Concomitant medications included duloxetine hydrochloride (CYMBALTA), levothyroxine and birth control pills, all taken for an unspecified indication, start and stop date were not reported. The patient experienced grand mal seizure on 07Apr2021. The patient was hospitalized for grand mal seizure for 2 days. Therapeutic measures were taken as a result of grand mal seizure (anti-seizure medication). The outcome of the event was recovered with sequelae on an unspecified date. Information on the lot/ batch number has been requested.

hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme major; I broke out with multiple sores all over the left Breast; a strange Blister was on my left breast; Pain; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient has no medical history. Concomitant medication(s) included alprazolam (XANAX). On 08Mar2021 21:00, the patient became sick 11 hours after first dose and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left Breast and still am and was diagnosed with Erythema multiforme major from an autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then, I started bleeding again only 14 days after my period ended again. The pain and bleeding are as intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021 covid test type post vaccination=Nasal Swab, covid Test name post vaccination=Pi xel by lab, covid test date=31Mar2021, covid test result=Negative. The patient did not receive treatment for the events. The outcome of the events hemorraging, Erythema multiforme major, I broke out with multiple sores all over the left Breast, a strange Blister was on my left breast was not recovered, while recovering for the events nausea, fatigue, and headache, and unknown for the rest of the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. I was in good health before receiving the vaccine and never had skin issues or irregular or painful periods with this much bleeding.

Started 10 minute after the shot I was nauseous with a headache watery eyes , nose I had an asthma attack, the nurse I seen took me to a curtain room and gave me 6 pumps of albuterol my bp was dropping at first and I was extremely weak and I took 2 more puffs and my BP went up now and the nurse wanted me to go to the ER and I got up and almost fell I was so dizzy I was given Benadryl at the hospital and received chest X-rays and was watched over and I was continuing to take Benadryl and albuterol around the clock, I was itchy all over and I?ve had to take my albuterol more often then usual now even though feeling better my heat rate is all over the place and and my period is extremely off as well clotting, tissue passing as the vaccine is now itchy again and swollen and hurting after 2 days as of your symptoms were gone

Patient woke up with jaw pain and left arm pain. When this didn't subside, she went to the ER and was found to have an NSTEMI. cath showed no abnomalitys echo showed inferior/infeobasal hypkinesis differential: takotsubo cariomyopathy, viral myocarditis, vaccine reaction Patient wore a heart monitor for a week which showed no abnormalities. Since this time, she has had occasional chest pains, squeezing sensations and pressure. A return visit to the ER because of continued chest pains showed a normal EKG and negative troponin. She is scheduled for a cardiac MRI tomorrow on 4/27/21. She is currently taking 10mg Amlodipine, 25mg metoprolol, a statin and a baby aspirin. The amlodipine seems to have done the most with respect to helping with her symptoms. She does not smoke. 1 glass of wine per week. She is not overweight. She has low cholesterol and low BP prior to this. Only other medical condition prior to this was occasional migraines (2 per year).

My menstrual cycle was extremely heavy and I passed many large clots, similar to when I had a miscarriage except the heavy bleeding slowed in about 3 days and I completed my menstruation course as usual.

asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic reaction; felt itching of her throat; fingertip started turning purple; coughing a lot; hard time breathing; hot feeling around her arms and left side of body; it has been three days since she has been really sick; she is easily tired.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm left on 21Mar2021 around 16:15 (Batch/Lot Number: ER2613) (at the age of 41-year-old) as single dose for covid-19 immunisation. Medical history included allergic to shellfish, ongoing systemic scleroderma, ongoing raynaud's syndrome (6 years ago) and interstitial lung disease (6 years ago). Concomitant medications included amlodipine besilate (NORVASC), at 5mg three times a day, prednisone (MANUFACTURER UNKNOWN) via oral at 5mg once a day; mycophenolate mofetil (CELLCEPT) at 1000 mg twice a day, hydroxychloroquine phosphate (PLAQUENIL) at 200mg twice a day, omeprazole (PROTONIX) at 40mg twice a day, sildenafil citrate (MANUFACTURER UNKNOWN) at 20mg three times a day, atorvastatin (LIPITOR) at 40mg once a day, gabapentin (MANUFACTURER UNKNOWN) at 300mg once a day; all are ongoing and taken for systemic scleroderma. The patient did not receive any other vaccines within four weeks prior to the vaccination. History of all previous immunization with the Pfizer vaccine considered as suspect was none. On 21Mar2021, the patient experienced anaphylactic reaction and was rushed into to the emergency room after 25 minutes of receiving the vaccine. The patient stated she called the CDC they recommend not to take vaccine of the second dose. The patient stated now she just called and it has been three days since she has been really sick and they told her to call us because doctor at the emergency room at the hospital and specialist because she has an underlying disease (Scleroderma) and told her to double check if she does not take booster of Pfizer vaccine what is the effect in her body? patient stated they are giving her advice that if she does not take it can she can take the J&J. The patient explained after she was administered the vaccine, she went to the waiting area where they told her she should be held for 30 minutes then in about 15 minutes she started getting a hot feeling around her arms and left side of her body so she took off her sweater thinking that would make her comfortable because she was uncomfortable. The patient stated 25 minutes after sitting there the nurse asked if she was ok, so she went out for fresh air that day it was not hot in the hospital but the temperature was around 60 on Sunday so it was really nice weather and she went outside for a fresh breath of air for 5 minutes, stayed took off mask, and felt relieved. The patient went back inside of the room and felt itching of her throat, 25 minutes receiving the vaccine and it stopped when she received the epi pen. The patient stated she thinks she recovered from because since Sunday she has had different effects. Then coughing started 25 minutes so probably roughly around 4:45pm on 21Mar2021 and stated when they administered epi pen not sure time but probably after an hour was when she was reviving in the ER. The patient experienced fingertip started turning purple and this started 30 to 45 minutes when she was rushed to emergency room and because of everything going on she does not remember when it stopped. The patient stated the doctor gave her a shot of epi pen and hooked her up. They did a lot of things in the emergency room that she does not remember. She only remembers her whole hand was purple and they gave her the epi shot. The doctor asked does she know what he was holding, she responded an epi pen, and the doctor said yes. She confirmed she has never used an epi pen before since she has not had any other allergic life-threatening reaction from a vaccine. The doctor said he was going to administer it right now because she cannot breathe. At this time, she was conscious and had a hard time breathing, but was listening. The doctor administered the shot and the hard time breathing and coughing stopped like 30 seconds after. However, she is still having a hard time to breathe. The patient stated the purple hands probably wore off after an hour but since she has Raynaud's disease it was hard for her to recover from circulation of oxygen in body. The patient had hard time breathing because Tuesday she still felt like asthma attack so around Tuesday still having hard time of breathing and still coughing a lot. The patient stated on Wednesday (on 24Mar2021) coughing was regulated a little bit and every time she was walking, she would cough. The patient commented she was discharged from the hospital Sunday. Later confirmed she was not actually admitted, just in the emergency room. The patient stated after the anaphylaxis reaction she was discharged at 9:30 in the evening and the following day she emailed her specialists and then replied and gave her advice that they could give and that she needed to call CDC vaccine and then they check on her. The patient confirmed she did actually go to her physician's office. On 22Mar2021, the patient felt weak she was lying in her house the whole Monday and lying-in bed week and had no appetite. The patient had an asthmatic reaction on Tuesday (on 23Mar2021), like hard time breathing, and she called her pulmonologist, and it was not like emergency and she knows that because she has an underlying lung disease, so she used nebulizer every 6 hours and also used inhaler albuterol inhaler. The patient had hard time walking and stated on Monday and Tuesday she did not get up from bed only just to go to the bathroom and to clean herself but yesterday she started walking around the house and it was hard for her because she was still coughing but today, she was walking already. The patient stated yesterday she was ok but had a hard time if walking it was hard for her to get up from bed and she can walk but she is easily tired. The patient underwent lab tests and procedures which included CT exam as part of her diagnosis for medical condition on an unspecified date and results are unknown. The patient stated she did not have an exam in the emergency room. Therapeutic measures were taken as a result of events anaphylactic reaction, felt itching of her throat, coughing a lot, fingertip started turning purple, hard time breathing, asthmatic reaction like hard time breathing included Epi Pen, Benadryl, she had an IV and the medicine administered through IV was a steroid combination of Benadryl pepa something, and stated she did not know the spelling, but it was a steroid mix that she received in the emergency room. The patient stated when she was home, on Tuesday, she had taken a nebulizer albuterol every 6 hours. She mentioned she just took Tylenol one time Tuesday night because she felt she was getting a fever. Her temperature was 99, not yet fever, but temperature was 99. The outcome of the events asthmatic reaction like hard time breathing was recovered on 24Mar2021, it has been three days since she has been really sick and she is easily tired was unknown and all other events were recovering. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

DVT of femoral vein of left lower extremity, shortness of breath during exertion, cough, diaphoresis, malaise/fatigue, chest pain, flu-like symptoms, POX 96%, woke up at 3am 4/14/21 short of breath and wheezing with POX 94%, headache, dizziness only when short of breath, left leg pain. Pt treated with Eliquis.

Pt. started having fever that evening, headache, and lower back pain (significant). Yesterday drove to ER due to continued severe lower back pain and pubic pain. On the way to the ER, she started bleeding a lot. At the hospital, she had a sono and was told she had an abortion. They performed a D&C. She was 10wks. This is 2nd pregnancy, which was uncomplicated pregnancy.

Vaginal bleeding/spotting since day after covid vaccine to present, also the day of to a week after, I had bloating and gas.

migraine; she felt like she had had her third back surgery; throwing up; diarrhea; stomach cramps; blood pressure has been so high/My blood pressure reached 200/198; I lost 30 pounds; I had a stroke; pulse high; in pain; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Mar2021 (lot number: not reported) as single dose for COVID-19 immunisation. Medical history included pain, anxiety, two back surgeries previously, and smoke all the time. Concomitant medications included clonazepam (KLONOPIN); and pain medications for her back and anxiety medications (unspecified). She got her first dose of the Pfizer COVID vaccine 36 days ago (11Mar2021) and within 5 minutes, she had the worst migraine of her life. She has had two back surgeries previously and after the COVID vaccine, she felt like she had had her third back surgery that night (11Mar2021). That night, she was also throwing up, had diarrhea and was having horrible stomach cramps. Since then (Mar2021), her blood pressure had been so high that they were afraid that she was going to have a stroke at any minute. For her migraine, she had been to the hospital 4 times for it and they had given her three doses each time of the migraine cocktail and that hadn't touched her migraine. She went back to the doctor and her blood pressure and her pulse were both still high (2021) and with the migraine she was ready to jump off of the dock because it hurts so bad. She was on 4 medicines to try and combat what this vaccine had done to her. She can no longer function. She needed to know an antidote or something to get this out of her system. She stated that she "is going to die from this". She didn't know what to do. They said she was going to have a stroke. She can't work and no one knows what to do because there were no studies on this because it is so new. She wanted it out of her body. Her life literally has turned into her just lying in bed and moaning in pain. She was in the emergency room (due to migraine), there were 3 people in there who had complained from the Pfizer vaccine (unspecified). She was calling because she got her first shot of COVID vaccine and she had a stroke (unspecified date in 2021) and she was going to die. She needed an antidote to get it out of her system because she been to the hospital 5 times now. She had migraine that is so bad that they gave her 4 doses of Topamax, it didn't touch it, she threw up everything she eats, she lost 30 pounds (2021) & her blood pressure reached 200/198 and she smoked all the time, they said she had stroke. She had bad migraine and nothing helped at all. She had doctor appointment, and nobody can give her answer. Regarding second dose, that was 21 days after, but she was not going to get it (second shot) and they said she was 80 % vaccinated. At hospital, when she was in emergency room (for migraine), where they do lab tests (2021), they were fine. She was not getting better, getting worse (not clarified for all events). Date of hospitalization: the day after she got the vaccine and next was two days ago, 3 different times (further details unknown). She further stated that she was driving to doctor. She lost her life because she can't work, this drug had ruined her life (as reported). The outcome of the event migraine was not recovered. The outcome of other events was unknown. Information about lot and batch number was requested.

bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shoulders, arm; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Apr2021 at 15:30 (3:30 PM) (at the age of 41 years old) (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies, and anxiety. Concomitant medications included bupropion; diphenhydramine hydrochloride (BENADRYL), and unspecified supplements. The patient previously took amoxicillin and experienced allergies. The patient experienced rash, hives, itching, bleeding, and pain in head, shoulders, arm on 14Apr2021 at 17:00 (5:00 pm). The patient did not receive treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient is recovering from the events. Information on the lot/batch number has been requested.

I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 14Apr2021 at 10:00 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. The patient was pregnant, last menstrual date: 14Feb2021, delivery date: 21Nov2021. The patient medical history and concomitant medications were not reported, no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 24Mar2021 at 19:15 (Batch/Lot number was not reported) (at the age of 41-year-old) as single dose for COVID-19 immunisation. On 14Apr2021 after she got the second shot of vaccine, the patient reported that she started to have cramps. At about 13:00 she started bleeding (light red). She called her doctor and she was told to go to doctor's office. At about 13:45 she had a new ultrasound. The doctor said that she did not find any heartbeat in the baby and that she was having an abortion. The patient underwent lab tests and procedures which included pregnancy test: she tested positive for pregnancy on 17Mar2021; ultrasound: everything was ok with the baby, the doctor confirmed that the baby was the right size and had a heartbeat on 05Apr2021 and abortion, the doctor said that she did not find any heartbeat in the baby and that I was having an abortion. The patient outcome of the events was not recovered. Information about the Lot/batch number has been requested.

About 15 mins after vaccine I felt a sudden onset of lightheadedness and feeling as if i would pass out, told the nurse I was going to throw up. I was given zofran and Dr monitored Vs. I continued to experience waves of dizzyness, nausea, abdominal pain. Shaking followed (I felt so cold), along with frequent need to urinate and urgency to have a BM (loose) for several hours. I was given fluids and monitored. They gave Ativan 0.5mg 2.5 hrs later? I was discharged home at 8:45p.m. by Dr and told not to get the 2nd Vaccine. Symptoms continued and worsened on day 3 with Shortness of breath, chest pain and tingling in my arms that spread to my legs, back and neck. The first week I could barley walk and was seen in the ER 2 times for chest pain, shortness of breath, dizzyness, tingling, heart racing, diarrhea, nausea, muscle weakness, insomnia due to shortness of breath (gasping) with heart racing, & unable to control my body temperature. Given Prednisone 40mg which exasperated symptoms. 1/13/21 In ER and given Benadryl 3 bags of fluids, potassium and sodium. Postural tachycardia was noticed. Referral to Neurologist.High D-dimer at ER on 1/16/21 CT scan performed to rule out blood clot in lungs. Reffered to Cardiologist. Metoprolol and Colchicine was started in Jan by Cardiologist Dr . Weekly visits with Dr for the first couple months. More meds started to decrease inflammation. Furthur referrals to Immunologist, infectious disease, and Rheumotology. At 3 months worsening of tingling in my neck and headaches/burning that felt like shocks and shooting down neck and ears. Neurologist performed 3 view MRI to rule out transverse Myelitis. In ER early April for new onset of Petechiae, CBC labs normal. Immunologist states he felt i experienced an allergic reaction followed by secondary anaphalaxis. He is testing me for Mast cell activation syndrome (not diagnosed yet). Now almost 4 months later still unable to work. Waiting results to rule out POTS. Currently battle daily fatigue, chest pressure/pain, lung SOB, heavyness/pressure, with any exertion. I am limited with daily walking/normal activities. Symptoms that come and go are tingling, nausea, diarrhea, flushing of frequent urination, neck pain, regulating temperature.

Clotting and breakthrough bleeding for 4 weeks following 1st vaccination, then swelling of lymph nodes 48 hrs. following 2nd vaccination.

Menstrual cramps and bleeding that started a day after the vaccine and have lasted over a week. This started 2 weeks after my last period.

Left calf pain started around 4/12; went to Total Access Urgent Care on 4/28 as pain had increased with minor swelling and Ultrasound showed DVT.; swelling; Ultrasound showed DVT; This is a spontaneous report from a contactable other healthcare professional (patient). A 41-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Apr2021 (Lot Number: er8733, at age of 41 years old) as single dose for COVID-19 immunisation. The patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications included: Levonorgestrel; Pravastatin. The patient previously received Penicillin, dairy products. Left calf pain started around 12Apr2021; went to Total Access Urgent Care on 28Apr2021 as pain had increased with minor swelling and Ultrasound showed DVT (Deep vein thrombosis) in Apr2021. The adverse event result in Emergency room/department or urgent care. The patient received treatment for the adverse event: On Eliquis blood thinner for 3 months. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contribution of the suspect drug administration to the event deep vein thrombosis cannot be excluded, due to 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 to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Transient moderate headaches and nose bleeds 3-7 days post-injection, including sneezing out blood clot Menstruation lasted longer than normal Mild fatigue 1-5 days post-injection

Pulmonary Emboli, Shortness of breath started on 4/30/2021, just after arthroscopy of RLE on 4/28/2021.

Blood clot in neck; Shortness of breath (dyspnea); Pressure on her chest; Edema to her feet; Weight gain of 2 pounds overnight; Rash on chest; Rash on chest, possibly due to tape (dermatitis contact); Heart palpitations; Oxygen saturations dropped to 85% on room air; Diarrhea; This is a solicited report based on information received by Pfizer. A contactable consumer reported that a 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization; treprostinil sodium (REMODULIN), intravenous from 03Mar2020 to an unspecified date at 0.041 ug/kg, then at 0.045 ug/kg with therapy dates unspecified, and then at 0.049 ug/kg with therapy dates unspecified, for primary pulmonary arterial hypertension; and macitentan (OPSUMIT) on 11Jan2021, orally from 11Jan2021 at 10 mg, 1x/day for primary pulmonary hypertension. Medical history included ongoing primary pulmonary arterial hypertension. Concomitant medication included sildenafil citrate. On 15Jan2021, the patient had a blood clot in neck. The patient was hospitalized from 15Jan2021 to 16Jan2021 due to the blood clot in neck. It was reported that on 15Jan2021, which is 10 months 13 days after initiating IV Remodulin, the patient was hospitalized due to blood clot in her neck. The patient went to the emergency room on 15Jan2021 and she was planned to be admitted to change her catheter, later she was hospitalized on the same day and her Remodulin central line was changed as per the prior plans of getting the catheter changed. The patient was discharged on 16Jan2021. The patient then had a rash to her chest (dermatitis contact previously reported) that started on 20Jan2021. The patient believed it was from the original dressing that was placed after her catheter was replaced. The rash to left chest around her Remodulin catheter line (dermatitis contact previously reported) was also reportedly itchy at night. On an unknown date in 2021, the patient's oxygen saturations dropped to 85% on room air (oxygen saturation decreased). The patient continued to have rash on her chest (dermatitis contact previously reported). On 29Jan2021, 10 months 27 days after initiating IV Remodulin, the patient was in the emergency room due to increased shortness of breath, pressure on her chest, edema in her feet and a weight gain of 2 pounds overnight. All the tests were negative but during walking test, the patient's oxygen saturation dropped to 85% on room air. The patient was advised to wear mask continuously. 2 weeks after receiving the first COVID-19 vaccine, the patient had heart palpitations, shortness of breath, and chest pressure 2 weeks after receiving the first COVID-19 vaccine (dyspnoea and chest discomfort previously reported). The patient went to the ER (emergency room), had worked up and was seen by a pulmonologist, nothing was found, and the patient was released home. The prescribing physician's practice ordered her to wear oxygen (O2) continuously. The patient said that she only wears it when she leaves the house and at night and was fine. She felt this episode was related to the COVID-19 vaccine and was not receiving the second dose. The patient stated that her physician had took her off the Opsumit due to shortness of breath (dyspnoea previously reported). The events 'blood clot in neck', 'shortness of breath (dyspnea)', 'pressure on her chest', 'edema to her feet', 'weight gain of two pounds overnight' and 'heart palpitations', resulted in emergency room visit. The event, 'diarrhea', was controlled with diphenoxylate and atropine (LOMOTIL). The patient had a walking distance test on an unspecified date in 2021 (results were not provided) and weight was 209 lbs on an unspecified date in 2021. The events, shortness of breath (dyspnea)', 'pressure on her chest' and 'heart palpitations', was reported as serious (medically significant). The events rash on chest, and rash on chest possibly due to tape (dermatitis contact) had not resolved while the outcome of the rest of the events was unknown. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (12Mar2021): This is a follow-up solicited report based on the information received by Pfizer. Additional information included medical history, suspect drug data, reaction details and clinical course details. Information on the batch/lot number has been requested. Follow-up (04May2021): This follow-up is being submitted to notify that the batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the available information the events are most likely related to an intercurrent or underlying condition which is not related to the subject drug. There is a reasonable possibility that the drug contributed to occurrence of the event rash. The follow-up information received does not alter the previous company clinical evaluation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Developed a blood clot. Symptoms presented by 03/05/21 (palpable bump behind left knee). By 03./07/21, the area was red and hot to touch with a palpable cord extending in both directions from the original bump. Blood clot diagnosed on 03/09/21. Xarelto prescribed on 04/23/21 (10 mg once daily). Symptoms persist as of today (05/23/21).

After 2nd dose, about 24 hours later my period started (I?m about 4 days early). I usually have extremely heavy periods, but right now it?s thick blood clots. Having bad endo stabbing pain. My period lasted 12 days after taking my 2nd dose. Which was 3 days longer than usual. And now, 17 days later, I started menstrual cycle again (too early)! I have the biggest & most blood clots that I have ever seen & heavy period.

blood clots were found in my right leg, 6 to be exact, no known origin of the clots. Had a stent placed on 3/9 almost lost my big toe and pinky on right foot. Now i am experiencing bp spikes that have gone up to 220/100 and drop within 15 mins. No known origin. They cannot put me on blood pressure meds because it drops so quickly without medication.

About a month and 20 days after my second vaccine I had trouble breathing. I work in the hospital, so I thought maybe it was bronchitis, the mask made it harder to breathe. I had the weekend off and decided by Monday I would go to the doctor if not better. I woke up on Sunday, still achy, not wanting to move, couldn't really eat, I was just mostly drinking water. I woke up Monday and came back to bed, moved the blanket and then could barely breathe. My skin got very clamy, feeling scared and unsure if it was a heart attack. I called 911 and was taken to hospital to a shock trauma. I am only back to work 4 hour days, and working with a pulmonologist.

After vaccine on 4/18/2021, major chest pain, shortness of breath, fatigue and sweats began. 4/22/2021- went to Urgent Care doctor advised to go in ambulance to hospital, 4/22/2021 I was admitted in hospital for pericardial effusion and had surgery on 4/26/2021 for pericardial Effusion Tamponade.I was in the hospital for 8 days. No pre-existing conditions prior. Treatment was to surgically remove fluid from sac & drain, oral Colchicine for 3 months to prevent immediate inflammation. Continue to follow up with Cardiologist to check for effusion.

On May 27, 2021 at 9:20am, I experienced drooping of the right side of my face, weakness in my right arm and leg, and right cheek, arm and leg paresthesias. I was taken to the ER where I was diagnosed as having a transient ischemic attack (TIA).

About an hour after I got vaccinated, I started to go into anaphylactic shock. My throat started to close and I was having adrenaline rushes, heart rate instability, and dizziness. I felt very shaky and weak. I was able to reverse it with Benadryl and other antihistamines. I did not need my Epipen. My symptoms subsided after about 4-5 hours. I did not eat anything after getting the shot, and I was not exposed to any other allergen that could have caused an anaphylactic reaction. I have not started any new medications that could have caused this either. I believe my reaction was related to the vaccine.

On April 10th, I developed unprovoked pain in my lower left calf. I went to my primary doctor April 12th, who sent me for a doppler scan to rule out DVT. It came back negative. I was told it was likely a calf muscle strain & to rest it. The pain was still active when I received my second vaccine dose on April 18th. On April 19th, I fainted at home, had several seizures, and difficulty breathing. I was sent by ambulance to the emergency room. There I suffered a massive pulmonary embolism, cardiac arrest, and numerous cascading issues affecting my liver, lungs, kidneys. I underwent a thrombectomy and several other procedures. I was told by doctors that less than 10% of people survive what I went through. con't

Anaphalactic Reaction treated by double dose of hydroxyzine on site at clinic. Throat swelling - hard to swallow all day - went away next day. 4/22 - Legs heavy, tired for two days. May 8: Spasms/Twitching - Left side of head behind ear, which continues to this day. May 10 - Hearing loss - ear muffled, full feeling; Entire left side head felt inflamed, swollen at base of skull. Dr. sent bloodwork which showed high inflammation marker. Said I needed temporal artery biopsy. Consulted with surgeon that day and scheduled for biopsy on 5/11, which came back negative for arteritis. During surgery recovery started 16 day prednisone taper after inflammation still high crp levels. this helped my ear in the long run. still have tinnitus. Since 5/10 I've been seeing Drs for all left side symptoms of: tinnitus, nerve pain, sharp stabbing pains in head, moving nerve pains in head, base of skull pain, left side head soreness - dull, achy, burning, sharp - ever changing in nature, insomnia, new allergic reactions to different foods, anxiety, new electrical shocking/zaps in left toes and in front teeth, PTSD from th severity and frequency of symptoms, eye floaters/damage, spasms/twitching. Been in physcial therapy for 6 weeks. New nerve pains in limbs. Lightheadedness and some speech changes. Similar to COVID long haulers - never had COVID.

She was calling to see if she could get more info about side effects she is experiencing.; eye twitching; rash on her forehead, below her lip, on her leg; itching; pain; swelling in her arm; headache; fatigue; vaginal spotting; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 14Mar2021 as DOSE 1 (age at vaccination: 41), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she was calling to see if she could get more info about side effects she is experiencing, eye twitching, rash on her forehead, below her lip, on her leg, itching, pain, swelling in her arm, headache, fatigue and vaginal spotting on an unspecified date. Caller asking if she should seek medical advice. Outcome of all the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained

Rapid heart rate, arrhythmia felt at 7pm 12/30, still present in morning 12/31/20, at 7:00 am was found to be in afib on monitor at work (I am a surgeon). Treated in emergency room after EKG confirmed a-fib. Received potassium and flecainide and converted to normal sinus rhythm after several hours.

Started with hives approximately 15 minutes after and then went into full Anaphylaxis. Required epi and Benadryl.

Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination - bleeding at the injection site which the employee reports as filling the bandaid over the site. When she got home in the evening and took it off blood ran down her arm but the bleeding stopped immediately. This has resolved. 12/29 at about 2:00 employee reports onset of tingling in the fingers of her right hand - index, middle, ring, and pinky. For about 2 hours the tingling was intense. As of 12/30 this has markedly improved and the tingling is intermittent. Later in the evening of 12/29 she noticed the onset of muscle pains throughout her body but especially in her feet. She also became very fatigued. These symptoms linger on 12/30. On 1/1 employee reports symptoms muscle soreness had resolved. 1/4 tingling in her fingers/arm has improved but is still present. She will follow-up with her PCP if this symptom persists beyond 2-4 weeks.

Headache, Bleeding, Myalgia, Arthralgia, Angioedema, Sweats/Chills with normal temperature, ipsilateral (left) axillary pain w/o lymphadenopathy erythema, or rash. Epistaxis, eyelids puffy. Extreme fatigue Narrative: Chills fatigue, body aches, no fever, no hot flashes, HA. Left (ipsilateral to injection) axillary pain but no palpable nodes. Ipsilateral axilla. skin feels raw, but looks fine. Awoke 0400 with nose bleed. Puffy eye. Warm compress. No help.

Patient was under the 15 minute post-vaccination observation period when she presented with signs and symptoms consistent with an anaphylactic reaction. Facility administered Benadryl, then an EpiPen, and called 9-1-1. Patient was brought to the hospital.

anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous report from contactable pharmacists and an other hcp and a nurse. A 42-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) intramuscularly on 25Jan2021 15:15 in right deltoid at single dose for COVID-19 immunization. Medical history included hypertension. No known allergies. Concomitant medications included high blood pressure medication. Patient was not able to breathe or talk. Her throat was closing up. They had to use epinephrine to help her breath. It was reported as anaphylactic reaction. The vaccine was administered at 15:15, patient was interacting with HCPs who asked basic questions and at some point (15:17) patient was not responsive, patient was not able to breath and talk. All events started from 25Jan2021 15:17. Patient was administered Epipen (also reported as Benadryl and Epinephrine) and "she came back". Patient was taken to hospital. Patient refused to call an ambulance. She was taken to hospital. The patient was not seen in the Emergency Department. The patient was not admitted to an Intensive Care Unit. No other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient has not received any other vaccines around the time of bnt162b2 vaccination. The patient underwent lab tests and procedures, which included heart rate with result of went up as soon as epipen was administered, O2 saturation and vitals with unknown results, all on 25Jan2021. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the anaphylactic reaction with throat closing up and being unable to breathe or talk. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Vaccine given 1-6-21, patient had a stroke left occluded carotid with dissection 1-11-21, no risk factors. 1-20-21 had second stroke, hospitalized for both episodes without residual symptoms.

Two days after the 2nd injection I started to have chest pain and not feel right. I went to the Station where I volunteer. I did and EKG which showed Anterior Infarct. I went to the ER. They gave me 4 baby aspirin to take and some blood work. I was told the blood work showed elevated levels consistent with a blood clot as well. I had a CT scan to rule out a clot in my heart or lungs. Which it was negative. I was released and told to see a cardiologist in the next few days. I saw the cardiologist two days later who said I ended up with Pericarditis and that it should resolve on its own. I was feeling better until two days ago when I developed chest pain again. I again went to my fire station I volunteer for and did an EKG which showed Anterior Infarct. I am currently waiting for treatment from my cardiologist.

anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue tingled; sore/scratchy throat; metal taste in mouth; shakiness (like internal vibration); This is a spontaneous report from a contactable other hcp. A 42-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 03Feb2021 08:00 for covid-19 immunisation. Medical history included depression, anxiety, drug hypersensitivity to codeine, sulfa meds, influenza vaccine, food allergy to quinoa. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), colecalciferol (D3), docosahexaenoic acid, eicosapentaenoic acid, tocopherol (OMEGA 3), probiotics. The patient experienced anaphylactic reaction on 03Feb2021 08:30, flush face with itching on 03Feb2021 08:30, throat became itchy on 03Feb2021 08:30, tongue tingled on 03Feb2021 08:30, sore/scratchy throat on 03Feb2021 08:30, metal taste in mouth on 03Feb2021 08:30, shakiness (like internal vibration) on 03Feb2021 08:30. Patient went to Emergency Room and was treated with Benadryl, Pepcid C, Decadron, Epi. The outcome of the events was not recovered. Information on the lot/batch number has been requested; Sender's Comments: Based on the available information, a possible contribution of the drug to the event anaphylactic reaction 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.

Patient was determined to have an anaphylactic reaction by MD's on site. Benadryl was administered, followed by Epinephrine 10minutes after Benadryl. EMS was called at that time and patient was transferred to higher level of care via ambulance.

Approximately one hour after receiving the vaccine, I had light vaginal spotting. Within a few hours, the spotting increased to a light bleeding with fatigue and cramping in the abdomen and has remained this way. I am still currently bleeding. My last period ended 3/7/21. My period is never irregular.

Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary obtained dopplers and CT chest, which showed DVT's and PE. Patient had shoulder surgery 3 months ago, is more sedentary than had been.

Miscarriage; Heart stopped on pregnancy; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration in the left arm on 26Feb2021 06:00 PM at a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. The patient was 8 weeks pregnant at the onset of the event. Last menstrual date was on 01Jan2021. There were no concomitant medications in two weeks and no other vaccine in four weeks. The patient previously received her first dose of BNT162B2 on an unspecified date at 06:00 PM in the left arm for COVID-19 immunisation. The patient had not been diagnosed with COVID prior to vaccination. The patient experienced miscarriage and heart stopped on pregnancy on 02Mar2021 03:00 PM. Treatment was unknown. Event resulted in doctor or other healthcare professional office/clinic visit. The patient was due to deliver on an unknown date. The patient underwent Covid PCR test post vaccination on 04Mar2021, pending results. Outcome of the events was unknown. Information on lot/ batch has been requested.

Patient received dose at a clinic provided by store pharmacy at 9:30 AM on 2-25-2021. Patient stated she started to have anaphylactic reaction to the Pfizer -Biotech COVID vaccine around 7:00 PM that same day. Her eyes swelled up and her throat started to feel like it was closes so she went to the ED at Hospital. At the hospital, she received an Epipen and a shot of benadryl. The reaction was taken care of and she was able to return home later that night with no lingering effect of the reaction.

Irregular vaginal bleeding & menstrual type cramps. Started approximately 48 hours after receiving vaccine. Has continued on & off since receiving vaccine, usually lasting 1-2 days, then stopping for 2-4 days.

10 days after my first shot my feet were swollen and I didn't feel well by 18 days after it was not getting better. I got my 2nd shot on day 21 and the day after I got an alert on my Watch regarding resting heart rate exceeding 125bpm and have been inactive for 10mins, so my husband call the doctor's office to make an appointment. They said we could go to the appointment or hospital, so we went to the hospital.

Vaginal bleeding and cramping similar to menstruation the same night as second dose was administered. Last menstrual cycle was on 11/06/2020. No period since then (due to birth control). On 03/27/2021 I started bleeding and thought how weird after all this time of not having it. The flow is light throughout the day but when go urinate there are little blood clots almost every time. The cramps are sporadic and the bleeding is going on 2nd full week without no break in between as of this date.

Three days after receiving the vaccine, I developed a blood clot in the lining of my stomach.; This is a spontaneous report from a contactable consumer. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 11:30 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, norgestimate (SPRINTEC) taken for an unspecified indication, on an unspecified date. On 18Mar2021 05:30 the patient experienced three days after receiving the vaccine, developed a blood clot in the lining of her stomach (thrombosis). The patient was hospitalized for three days after receiving the vaccine, developed a blood clot in the lining of her stomach for 3 days. Therapeutic measures with blood thinners were taken as a result of three days after receiving the vaccine, developed a blood clot in the lining of her stomach. The outcome of the event was recovered. Information on Lot/Batch number was available. Additional information has been requested.

I was admitted to ER with stroke and right arm weakness. While I was in the ER, I also developed unconsciously seizure. The diagnosis are Cerebral Venous Thrombosis (CVT, multiple clots) and Cerebral Venous Sinus Thrombosis (CVST), Focal motor seizure and Cerebral Edema.

Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was experiencing SOB but all blood work normal - assumed normal SOB with pregnancy. Night/morning of 4/15 started seizures, transported to ED. Diagnosed with massive pulmonary embolism. Emergency C-section prerformed by Dr. Pt. did not survive.

Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly started a couple weeks after the vaccine and eventually worsened to the point of not being able to open my mouth. Symptoms included facial paralysis, Muscle weakness, fatigue, vision issues, Neuropathy issues. I was transfused with multiple doses of Immunoglobulin and IV steroids. Still currently in Physical therapy I have lost 3 months of not being able to work. Also had a blood clot

Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a deep breath; dizzy lightheaded; Had tingling in my feet; headache; chest pains; This is a spontaneous report from a contactable consumer (patient). A 42-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:00 (at the age of 42-year-old) (Batch/Lot Number: Ew0158) as SINGLE DOSE for covid-19 immunisation. Medical history included Asthma, anaphylactic reactions to shellfish, PCN, codeine. Known allergies included: PCN, codeine, nuts, shellfish, potatoes, green beans, apples, tomatoes. Concomitant medication(s) included loratadine (CLARITIN [LORATADINE]) taken for an unspecified indication, start and stop date were not reported; polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported; magnesium (MAGNESIUM) taken for an unspecified indication, start and stop date were not reported; iron (IRON) taken for an unspecified indication, start and stop date were not reported. The patient took Clartin, fiber, b complex, magnesium, iron, probot in two weeks. The patient previously took first dose of bnt162b2 in left arm on 20Mar2021 at 14:15 (lot number=Er2613) for covid-19 immunisation. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 11Apr2021 02:00 AM, the patient experienced Anaphylactic reaction to vaccine. Felt like an elephant was sitting on her chest. Could not take a deep breath. She was also dizzy lightheaded. Had tingling in her feet, headache and chest pains. Most of her symptoms went away after she was given a high dose of Benadryl and prednisone. She also has asthma and a history of delayed anaphylactic reactions. It will be a 4-5 days before her lungs completely recover from this. AE Resulted in Emergency room/department or urgent care. Outcome of the events was recovering.

Patient received 1st dose of Pfizer Covid vaccine on 4/21, and on 4/22 had 2 generalized tonic clonic seizures. No previous seizure history prior to this event. Workup for etiology of Seizure was unremarkable (MRI Brain, CSF studies, UA/CXR)

1 week after injection I developed superficial blood clots in my Left Calf, that still have not resolved. Left arm and shoulder pain and headaches.

DVT; PE; This is a spontaneous report from a contactable physician. A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the left arm, on 28Jan2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension (HTN) and fibroids. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Concomitant medication included amlodipine besilate (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly in the right arm, on 07Jan2021 (at the age of 42-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced deep vein thrombosis (DVT) and pulmonary embolism (PE) on 29Jan2021, which caused hospitalization for 5 days from an unspecified date to an unspecified date. Therapeutic measures were taken as a result of the events, which included direct oral anticoagulants (DOAC). The clinical outcome of DVT and PE was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; 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 Deepvein thrombosis,pulmonary embolism cannot be excluded.But also consider relevant medical history of hypertension and fibroids tendency to form blood clots and concomitant medications also have possible 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.

Began with hives on hands and neck area 3 days after covid vaccine, I took benadryl before bed and woke the next morning to hives spreading to entire body. I took another dose of benadryl mid day. By evening I was in anaphylaxis with swollen lips and itchy gums. Went to the ER and received ephnephrine, intravenous benadryl, pepcid and prednisone. Was monitored for 3 hours, swelling was gone and symptoms had subsided. Went home. Next morning symptoms were less but feet were tender to walk on and hands and feet were itchy. Picked up prescrription prednisone and loratadine and took both that morning. By evening afternoon was very itchy and hives on back, legs, arms and neck took benadryl that evening which helped but currently itchy red hives on arms, hands, neck, legs and feet - all over body. A new symptom is very swollen lymph nodes in neck.

fibromuscular dysplasia; 3 artery dissections; narrowing of other arteries; chills; aches; fever 101; left neck and chest swollen lymph nodes; stomach aches; abdominal pain; It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die; heart attack; left flank pain; This is a spontaneous report from a non-contactable consumer (patient). A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on left arm on 19Jan2021 (Batch/Lot Number: EL3249) as SINGLE DOSE for covid-19 immunisation. Medical history included post-partum hypothyroidism. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EK9231) via an unspecified route of administration on left arm on 29Dec2020 for covid-19 immunisation. The patient stated "The day after second vaccine and that week, I had chills, aches, fever 101, left neck and chest swollen lymph nodes, stomach aches. 28Jan2021, I started having severe left flank pain and abdominal pain. On 04Feb2021, I had a heart attack, was in V-fib arrest, and subsequently found to have fibromuscular dysplasia (FMD), which caused 3 artery dissections and narrowing of other arteries. Did not know I had FMD prior to the heart attack. Most people who have FMD never show signs or symptoms and don't know they have it. Others with FMD have it affect maybe one artery. Something caused my FMD to go into overdrive, affecting 3 arteries. It also affected a renal artery, causing lack of blood to my left kidney, causing part of that kidney to die - that was my 28Jan2021 pain. Coincidental my FMD acted up this way a little over a week after receiving the second Pfizer shot?" Events were reported as serious and 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). The patient hospitalization for 9 days. Treatment received for all events. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal Swab): negative on an unknown date (Covid test post vaccination). The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

After taking normal medications prior to bed became acutely short of breath, mother states patients face turned blue then respiratory arrested followed by cardiac arrest. CPR was performed for approximately 10 minutes before pulse returned.

Hospitalized 18Apr2021 with bilateral Pulmonary embolism; This is a spontaneous report received from a contactable nurse (who is also the patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 02Apr2021 11:00, as single dose, for COVID-19 immunisation, at a pharmacy/drug store. Medical history included esophageal dysmotility, thyroid nodules, ACL tear and ACL repair on 15Apr2021. The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO); and paracetamol (TYLENOL), both taken for unspecified indications, start and stop dates were not reported. The patient previously took prochlorperazine (COMPAZINE) and experienced allergies. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported) at age 42 years, via an unspecified route of administration in the left arm, on 19Mar2021, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. The patient was hospitalized on 18Apr2021 with bilateral pulmonary embolism (onset date was 18Apr2021). Treatment for the event included Lovenix. The patient underwent COVID nasal swab on 05Apr2021 and 18Apr2021 which both resulted to negative. The outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported bilateral pulmonary embolism 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 to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Injection site tenderness, flu-like symptoms including headache, low grade fever, muscle and joint aches, chills, making work impossible for two days. Intensely painful and heavy menstrual period a week later, including passing palm-sized blood clots and intense pain that did not subside with otc pain killers, TENS therapy or heat. Patient does not have a history of painful menstrual periods.

flu-like symptoms; given an injection of steroids/difficulty breathing; difficulty breathing; fever 100F; chills; body aches; chest tightness; abdominal pain; This is a spontaneous report from a contactable other HCP (patient). This 42-year-old female other HCP reported for herself received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 12Mar2021 10:00 (Batch/Lot Number: EN6206) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunisation. Medical history included asthma (well controlled prior to vaccine) migraines, chronic UTI, bronchitis, pneumonia, all from an unknown date and unknown if ongoing. The patient did not have COVID prior to vaccination. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction ("given an injection of steroids/difficulty breathing") on 13Mar2021 with outcome of not recovered , difficulty breathing on 13Mar2021 with outcome of not recovered , fever 100F on 13Mar2021 with outcome of not recovered , chills on 13Mar2021 with outcome of not recovered , body aches on 13Mar2021 with outcome of not recovered , chest tightness on 13Mar2021 with outcome of not recovered , abdominal pain on 13Mar2021 with outcome of not recovered , flu-like symptoms on 15Mar2021 with outcome of not recovered. The patient underwent lab tests and procedures which included body temperature: 100F on 13Mar2021 , oxygen saturation ("O2 stats"): between 88-93 for 3 weeks, sars-cov-2 "antibody" test: positive on 16Apr2021 (blood test) , CXR with unknown result on 17Mar2021. Therapeutic measures were taken as a result of the reported events included injection of steroids and antibiotics.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events. There is limited information provided in this report. 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.

She began having shortness of breath after getting her second shot. He parents found her dead in her bed this afternoon. No other known comorbidities.

Blood clot in right calf; This is a spontaneous report received from contactable consumer for herself. A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 11Apr2021 17:15 (Batch/Lot Number: EW0151) as 2nd dose, single for covid-19 immunisation. No pregnancy at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history allergy to penicillin. The patient's concomitant medications were not reported. Historical Vaccine included the first dose of BNT162B2 on 21Mar2021 05:15 PM in Left Arm (Batch/lot number: Ep6955) as 1st dose, single for COVID-19 Immunization. The patient experienced blood clot in right calf on 15Apr2021 03:00 AM. The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measures were taken as a result of blood clot in right calf included Blood thinners. No Hospitalization Prolonged. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering.

pulmonary embolus; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170) via an unspecified route of administration at left arm on 06May2021 (42-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (prior vaccination), asthma, allergies to sulfa, and allergies to PCN. Concomitant medications in two weeks included escitalopram oxalate (LEXAPRO), fexofenadine hydrochloride (ALLEGRA), and multivitamin (unspecified). The patient previously received naproxen sodium (NAPROXEN SOD) and experienced allergies; ipratropium bromide (ATROVENT) and experienced allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810) via an unspecified route of administration at right arm on 15Apr2021 (42-year-old at time of vaccination), at single dose, for COVID-19 immunization. There was no other vaccine in four weeks. The patient experienced pulmonary embolus on 07May2021. Adverse event resulted in emergency room/department or urgent care, life threatening illness (immediate risk of death from the event). The patient did not test for COVID-19 post vaccination. Therapeutic measures were taken as a result of the event and included blood thinner. The outcome of the event was recovering.

Chills, body aches, shakiness, twitching in my hands & feet, feeling of restless leg syndrome, increased seizure activity including petite mals and grand mals, migraines, raising my voice for no apparent reason (not angry, just catching myself yelling and not knowing why) involuntary crying at random, increased instances of narcoleptic episodes, hallucinations, nausea and vomiting

Severe vaginal bleeding not in line with the normal menstrual cycle. An extreme number of nickel-size clots and medium to severe cramping, which is not normal at all for me.

bleeding; This is a spontaneous report from a contactable consumer (patient). A 42-year-old not pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 06Apr2021 10:30 (Batch/Lot Number: ER8734) as UNKNOWN, SINGLE for covid-19 immunisation. Medical history included allergies to Penicillin, turkey, chicken. Patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had vaccine on 06Apr2021 and that evening about 22:00 started bleeding very heavy. She bled for 2 1/2 weeks changing overnight pads ever 45-60 minutes. On 21Apr21 was bleeding so bad. Changing pads every 10 minutes. Patient went to the emergency room and was gave a very heavy dose of hormones to stop the bleeding. She went to see gynaecologist on 23Apr21 and was scheduled for a hysterectomy due to all the bleeding. The event outcome was not recovered. The patient was hospitalized for bleeding (haemorrhage) for 1 day. The patient underwent lab tests and procedures which included Nasal Swab covid test: negative on 10May2021.

Admitted to the hospital for 5 days after ER visit. Had a heart attack. Was diagnosed with spontaneous coronary artery dissection.

Bruises on my thighs, looks like blood clots; Bruises on my thighs, looks like blood clots; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Left Arm on 17Apr2021 11:00 at the age of 42-years-old as single dose for covid-19 immunisation. Medical history included anaemia, iron deficiency. No known allergies. Patient was not pregnant, not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included iron, other vitamins such as biotin and minerals nos, vitamins nos (PRENATAL VITAMINS) within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced bruises on thighs, looked like blood clots on 17Apr2021. No treatment received for the events. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered. The events assessed as non-serious. Information on the lot/batch number has been requested.

Event - stroke without known precursors Treatment- currently in inpatient rehab Outcome - unknown if I will regain full use of right side 3 days at hospital and now currently in inpatient rehab with unknown discharge date

Anaphylaxis sharp pain left side by chest swelling in nape of neck by thyroid extreme sinus pressure between eyes tongue swelled glands under ears swelled throat swelled. Epi pen given by HCP in pharmacy

PATIENT DEVELOPED SEVERE ABDOMINAL PAIN, N/V, FEELING FAINT LESS THAN 24 HOURS AFTER ADMINISTRATION (THE NIGHT OF 6/3/21). ON 6/4/21 PATIENT WENT TO ER AND WAS GIVEN IV FLUIDS. ON 6/5 PATIENT PASSED BLOOD CLOTS IN STOOL THAT BECAME MORE SEVERE ON 6/6/21. 6/6/21 PATIENT RETURNED TO ER AND WAS DX WITH COLITIS AND A GI BLEED. PATIENT STATES A KNOWN ALLERGY TO POLYETHYLENE GLYCOL - TOOK BENADRYL BEFORE RECEIVING EACH DOSE OF PFIZER VACCINE PER THE GUIDANCE OF HER PRIMARY CARE PHYSICIAN. PATIENT HAD NO REACTION TO FIRST DOSE.

Extreme Thrombocytopenia (below 30,000) manifesting in bruising on arms, legs, torso, bleeding gums, bleeding nose. Was 30,000 at time blood drawn to test... by that point the symptoms were improving, so likely well under 30,000 in prior 1-2 weeks. Any effect on fetus (20 weeks) still unknown... being evaluated this week.

The next day after the vaccination at 3:00 PM, I felt bone pain, tiredness, with a fever and that lasted all afternoon until Sunday. On the same Sunday at 12 noon I started with a stomach ache (similar to some contractions) I went to the bathroom 4 times solid and then on the 5th excretion I saw blood and I thought it was menstruation, from then on I had 11 bloody stools; I was in a lot of pain. He had no appetite. Monday morning to the hospital (at 7AM) and I explained everything to them and they did several tests, they gave me medicine for the pain and the discomfort went away, and they discharged me. I was 8 days with treatment.

Nearly passed out twice; Passing blood clots; GI bleed; Severe body aches; Fatigue; Abdominal pain; Nausea; Vomiting; Fever; Diarrhea; Dehydration; Colitis; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 42-year-old female patient (not Pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) at 42-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 03Jun2021 06:30 PM (Lot Number: EW0179) as dose 2, single for covid-19 immunisation in Clinic. Medical history included hypertension, anxiety, seasonal allergy, asthma, Known allergies to Cephalosporin. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications received within 2 weeks included spironolactone; irbesartan; buspirone hydrochloride (BUSPAR); silybum marianum (MILK THISTLE), all 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. The patient previously took miralax and experienced Allergy, lisinopril and experienced Allergy, venlafaxine and experienced Allergy, patient previously took first dose of BNT162B2 (Brand: Pfizer, Lot number: EW0177) into left arm on 13May2021 06:30 PM at 42 years old for COVID-19 immunization. Patient experienced Severe body aches, fatigue, abdominal pain, nausea/vomiting, fever, nearly passed out twice, diarrhea followed by passing blood clots, dehydration, treated in ER twice. Once for dehydration, second for colitis with GI bleed. Event Start Date was 03Jun2021 09:00 PM. the adverse event result in Emergency room/department or urgent care. treatment received for the adverse event included IV fluids, antibiotics, and antiemetic. Outcome of the events was recovering. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case, however, a possible contributory role of the suspect drug to the reported events "Nearly passed out twice, Passing blood clots and GI bleed" cannot be completely excluded based on temporal association. This case will be re-assessed when 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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: ANXIETY-Medium, Additional Details: WE CALLED 911, paramedics came and her oxygen, heart rate, bpwas fine. pt was given option of going to hospital, but she did not want to go.

My hypertension was under control and got higher after the first shot. Went to my regular doctor for blood pressure medicine changes. On June 20,2021 when I received my second dose the same thing happened with my blood pressure and I went to the doctor Tuesday morning and went to the emergency room by 7pm. They ran lab tests and other tests and determined I had pneumonia. I have now been tested for influenza and Covid-19 and currently waiting on the results.

Hives swollen face and got anaphylactic shock bith both 1 and 2 series of pfizer vaccine Also got pericarditis was treated with predisone and benadryl also with an ansthma inhaler and got referred to see a cardiologist to check my heart because EKG showed possible LEft Atrial Enlargement but tests showed no LAE it is pericarditis

I had stroke on March 8th - I was teaching from home and I got super dizzy; I could see in front of me or focus. I felt like something was wrong and I called someone. She came over and said my face was drooping on one side. I didn't know what day it was. She called the ambulance. Medical Center ER - went there in the ambulance. Confirmed a stroke at the hospital. I had TPA; I didn't have any residual damage. They put me on a statin - Lipitor and a baby aspirin to take at home.

Well I had no other symptoms, no fever no day after problems like people say they have. I started spotting blood vaginally and by night time I was full blown bleeding. And to note, this is my 7th miscarriage in three years, it may not be shot related it may be just me. I had an appointment with my DR due to my history of miscarriages and I went in on Monday. My date was delivery was to be February 22 2022.

At the time of the 1st pfizer vaccine shot, I was 5 weeks 4 days pregnant. I had no issues with the pregnancy. I have been pregnant three times prior, naturally, with no issues carrying the pregnancy to term. My due date for the pregnancy was 12/4/21. After receiving the vaccine on April 8, 2021, I felt cramping and a contraction type pain (one that would come and go) on April 12, 2021. Four days after the pain, I experience spotting and increased bleeding until the confirmed miscarriage on April 22, 2021.

April 9th at 07.50 in the morning I had a acute left middle cerebral artery stroke. Paralyzed on all of the right side. Impaired speech. Brought in by ambulance at 08.10

Pfizer-BioNTech COVID-19 Vaccine: patient presented to emergency department 22 days after first immunization and one day after second immunization with right leg swelling for three days. Vital signs within normal ranges except heart rate 107 beats per minute. No cough or shortness of breath. Reports family history of deep vein thrombosis (DVT) and pulmonary embolism. Diagnosed with right leg DVT, prescribed anticoagulation, referred to outpatient follow-up, and discharged to home.

Early vaginal bleeding; having some cramping; This is a spontaneous report from a contactable Other HCP. A 42-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported/ Unable to locate or read the details) via an unspecified route of administration in Arm left on 08Mar2021 10:15 as single dose for COVID-19 immunization. Medical history was not reported. Patient has no allergies. Concomitant medication included doxycycline (ORACEA) taken for an unspecified indication and GNC multivitamin received within 2 weeks of vaccination. 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. The patient was tested for COVID-19 since the vaccination. On 10Mar2021 19:30 early vaginal bleeding, have regular periods and now bleeding < 2 weeks after last period and around 17:30 had some cramp. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab-Pixel LabCorp): negative on 10Mar2021. Patient didn't receive any treatment for adverse event. Outcome of the events were not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge blood clot from vagina, about the circumference of a clementine. was not old blood, looked like frank blood. over the next 30 hours, pt experiences more clots, much smaller, about the size of a pea. pt has a headache and chills throughout. 48+ hours, experiencing what feels like menstrual cramps. no blood clots 72 hours post injection

anaphylactic reaction 2 hours post vaccine, given 2 rounds of epi in the ED in addition to allergic reaction meds, still with rash.

first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, then 9 am hives everywhere, trouble breathing, anaphylaxis, went to ER, got epi X 2, solumedrol, benadryl, pepcid, then still with hives, tachycardia, dyspnea, iv fluids were influsing and epi drip started, went to ICU

I received my covid vaccine on 12/29/2020 at 4:42pm. In 10 minutes after the shot, I went into anaphylactic shock, I broke out in hives, and my throat was closing

Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Taken immedietly to ER, O2 sats observed of 84%. Given IM Epi in ER triage area. Brought back to room, racemic epi started and given additional IM dose. Please refer to ED for further treatment.

5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of breath tachycardia, nausea. Taken to ER and given IM Epi, IV Benadryl, Solumedrol, Pepsi?s, albuterol and racemic epi breathing treatments and put on Epinephrine IV drip to treat anaphylactic reaction

Hospital Course:   Patient is a 43 y.o. female patient who originally presented to the hospital on 1/3/2021 due to Left lower extremity pain and swelling. Patient found to have extensive DVT of left lower extremity and started on heparin drip. Vascular was consulted and recommended thrombolysis. Patient was also seen by IR who took patient for thrombectomy and left iliac stent placement on 01/05/2021. Patient tolerated procedure well. Patient was transitioned from heparin drip to Eliquis upon discharge. Patient given vascular follow-up as well as Hematology follow-up.

Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy and lightheaded/severe dizziness/felt like fainting; difficulty breathing; vomiting; This is a spontaneous report from a contactable nurse (patient). This 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EL1285) via intramuscular route on 29Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included anxiety. No known allergies. Concomitant medications were not reported. Patient was not pregnant. Facility type vaccine was Nursing Home/Senior Living Facility. No other vaccine received in four weeks. Patient hospitalized for stroke on 31Dec2020 two days after vaccine (Days of hospitalization: 4). Day of vaccine-6 hours after patient had dizzy and lightheaded for about 45 min then went away. On 31Dec2020 at 19:15 had sudden loss of hearing to right ear and severe dizziness, difficulty breathing, vomiting, and felt like fainting. Paramedics were called-sent to ER, had CTA which showed partial blockage and received TPA. Treatment included TPA, fluids, medications, hospital stay, outpatient follow ups, physical therapy. Patient was not diagnosed with COVID prior to vaccination. Patient has been tested for COVID post vaccination. The patient underwent lab tests and procedures which included Nasal Swab: Negative and Pixel: Negative on 08Jan2021. Outcome of the events was recovering.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported events including stroke, dizzy/lightheaded/felt like fainting, difficulty breathing, vomiting, and sudden loss of hearing to right, and the administration of the COVID-19 vaccine, BNT162B2. More information regarding the patient's underlying medical conditions, relevant lab tests would be helpful for the Company to make a more meaningful causality assessment.

Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an hour later, I started breaking out in hives and whole body itching. I went back in and they gave me to full strength Benadryl and it was not helping and my BP was 190/140 (stroke level) and they tried to bring that down. About 10:15 my face was starting to swell and I was short of breath and 10:30 they took me to ER - and gave me Cortisol shot. And IV fluids. And I was in ER for two hours. They wrote me a prescription for six days for 2 prednisone for every day for one week. The PA saw me at the ER and he prescribed. I went home but couldn't drive home because I couldn't see straight so got a ride home. They tested my O2 levels before they left me. Oxygen was 96. My blood pressure was down to 140/95 - so it was down but still elevated. I still had facial swelling for 3 days. But after three or four days it resolved the face swelling. Had a weakness from the shot and still itching but nothing like it was that day still after the four days. Dr. told me I couldn't get second dose. It was an anaphalactic reaction. Dr - prescribed me an EpiPen in case I have another bad reaction to anything.

Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically respiratory distress with stridor, nausea, and generalized abdominal pain.

15 minutes after first Pfizer Covid injection, pt developed itchy throat, given benadryl 50 po and monitored. Continued to have itchy throat and some rash, felt like prior episodes of anaphylaxis, reported some sob though stable vital signs, sent to ED

I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware of the pregnancy. I was diagnosed with COVID on 12/28/20, but was first symptomatic on 12/24. I attributed my s/s initially to the vaccine. I was eventually tested on 12/28/20, as my symptoms worsened and I was positive for COVID. On 1/14/21 I received my second dose, my COVID s/s had been resolved since 1/4/21. On the evening of 1/18/21 I started experiencing mild abdominal pain. This progressed, on the evening 1/20 the pain was no longer tolerable. I went to the ER where I hemorrhaged and needed emergency surgery and a blood transfusion for a miscarriage. The surgery ultimately took place in the early morning hours of 1/22/21, followed by the blood transfusion.

I was a healthy pregnant woman age 43 who was 11 weeks 2 days pregnant. I was having a normal pregnancy with no complications. I'm in healthcare and in the operating often for airway and ENT procedures. I received my shot at 9:00am on 1/29/20201 and began spotting at 11:00am. The spotting continued (very light) until 9:00pm. I decided to go to bed since I wasn't feeling well. I woke at 2:00am with contractions and heavy bleeding. I went to the ED at 3:00am on 1/30 to confirm my miscarriage. I weighed 121 at the ED when triaged. My EDD was 08/19/2021

I didn?t notice any symptoms right away. When they started, I didn?t think it was abnormal at first. I am female and still have my menstrual cycle. This time it appeared to be heavier than usual and had some blood clots. However, before I was on birth control it was always that way. Sometimes it is a little heavier when I have more stress or the weather is not ideal. My cycle started around 2/4/21. On 2/8/21, I combed my one cat. She scratched and bit me and has done so in the past. She and I both are vaccinated and I?ve never developed any infections because of it in the past. On 2/10/21, I noticed a cluster of red pinpoint dots underneath my skin on my arms and chest. They weren?t bumpy, warm to the touch, itchy or anything. It just looked odd and I didn?t know how it happened. I work with a Nurse Practitioner and she suggested I go into to a clinic as those usually indicate an infection is developing. I went to the Urgent Care and was treated. He did blood work on me and informed me that my glucose was a little low. It was suppertime so that didn?t surprise me. He told me there was no signs of infection in my blood work but was prescribing two antibiotics in case one developed. When I was getting my meds at the pharmacy, a call was coming through that I didn?t recognize so do to phone scams, I didn?t answer it. I started the antibiotics. Then over the course of 2/13/21 and 2/14/21 weekend days, I felt more fatigued than usual, nauseated, had a decreased appetite and still had my menstrual cycle. I still didn?t think much about it as a side effect of the antibiotics was nausea and decreased appetite and the fatigue could be related to it being so cold and winter usually affects my depression symptoms. Then on 2/14/21 I noticed my lower abdomen was covered in those red, pinpoint blood dot clusters and there were unexplained bruises on my body. I took a shower and when I went to wash my legs, my pelvic area was completely bloody and a blood clot dropped into the bathtub. Never has that occurred when I have my period. It looked like I had just given birth it was so much blood. I became nauseated and dry heaved several times. On 2/15/21, I sent a message to Dr asking what was happening to me. He called me and informed me that he had tried to call me the night he saw me because he saw my platelet count was only 11,000 and should be a minimum of 140,000. Dr asked that I return to Urgent Care as soon as possible. I arrived there around 12:30 pm that day. He had bloodwork done again on me. My platelets went down to 9,000. I explained that my menstrual cycle would not stop and it should?ve but I just keep bleeding. Dr contacted a Hematologist that informed him that recently the blood disorder Immune Thrombocytopenia (ITP) has been linked with the COVID19 vaccination in rare cases. I was scheduled to be seen by a Hematologist and put on the medication prednisone to build up my platelet count. I returned to Urgent Care for blood work again on 2/16/21. My platelets went up to 30,000. I met with Hematology on 2/17/21 and had blood work again, platelets 28,000. All providers looked over my medical record and noted that since my gastric bypass surgery in 2015, my health has been good, my blood work has been normal and I live a clean lifestyle. Again, the only issue showing up in my bloodwork was that my platelets were extremely low. Now I have weekly blood draws, take 80 mg of prednisone and have a Hematologist when just a few weeks ago my health was good.

8 hours after the shot= all my joints hurt. Joints that normally do not hurt did like my neck joint, right wrist joint. The joints that do normally hurt were way worse (my back, and right big toe joint). There was a pain in my right eye, and that eye had blood vessels burst in it. 36 hours after the shot= started bleeding from my vagina. My last menstruation was 2 weeks ago and this is VERY unusual for me. Normally my periods are 30-32 days apart.

I was 5-week pregnant at the time of second COVID-19 vaccine dose. I had a gush of yellow vaginal discharge on 2/11 and subsequently spotting and bleeding up until pregnancy loss on 2/20.

On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on the tissue. This happened a second time and then it was finished. I felt really tired and not myself. Then later that night my arm began to hurt so bad that I could not lift it. I began to rub the area that was hurting and noticed that I now had a nice size lump there . I took a Tylenol 500mg and a hot shower. When I woke up the next morning my arm was still hurting but not as bad. When I went to use the bathroom I had began to start spotting again. This continued throughout the day and now I am bleeding as if I was having my period. I am super tired. It is to the point that i cant function at work.

Received 1st vaccine at 3weeks, 2nd vaccine at 6 weeks, at 7 weeks saw baby and heart beat at 9 w5 d, started to spot and imaging showed no heart activity and baby stopped growing at 8w4d. D&C completed on 2/21 at 9w6d. No side effects from first vaccine, 2nd vaccine, body aches, fever (101) controlled with Tylenol, chills, joint pain, headache. Resolved after 3 days.

Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphylactic reaction; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the left arm, on 15Jan2021 at 06:30 (at the age of 43-years-old) at a single dose for COVID-19 immunisation. Medical history included COVID-19 (with taste and smell loss). The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), hydroxyzine hydrochloride (MANUFACTURER UNKNOWN), and duloxetine (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 17Dec2020 at 14:00 in the left arm for COVID-19 immunization and experienced head to toe itching and progress with taste and smell disappeared/worse than COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild anaphylactic reaction on 16Jan2021 at 20:00 and itching throat, cough, and taste and smell loss on an unspecified date. The patient reported that all the progress she made with taste and smell, disappeared after the vaccine and was actually worse than when she got COVID-19. Therapeutic measures were taken as a result of mild anaphylactic reaction, which included diphenhydramine hydrochloride (BENADRYL). The clinical outcome of mild anaphylactic reaction was not recovered and of itching throat, cough, and taste and smell loss was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on known safety profile, the contribution of the suspect drug to the onset of event anaphylactic reaction cannot be excluded.

Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing deeply, itchiness in mouth, blotching of skin

Starting on February 24, 2021, I started to have shortness of breath. This slowly got worse until on March 2, 2021 I was unable to breathe in all the way and was getting a sharp pain in my side/back when I tried to breathe in more than half way. I then went to the emergency room recognizing the symptom as likely being a pulmonary embolism, as I had experienced one four years earlier. It was, in fact, a PE. I was in the hospital for five days as they treated the clots with blood thinners. I slowly got my breathing more back to normal and was discharged. They are still runnying myriad tests to try to determine the cause or causes, but I thought it wise to report here in case the vaccine is a factor. I received my second dose on 2/26/21, a few days before I went to the hospital but my symptoms started a few days before that.

Patient was a 43 yo F who presented to ED on 12/25/2020 with complaints of worsening shortness of breath for past 3-4 days. The patient tested positive for COVID 12/16/2020 and her symptoms worsened three days prior to admission. Patient was diagnosed with COVID infection with acute respiratory failure with hypoxia. She was treated with dexamethasone 6 mg once daily for 3 days, Tussionex 5ml q12h prn for cough for 2 days. Patient was discharged home on 12/30/2020 with improved SpO2 and a discharge medication list of dexamethasone 6mg daily for 7 days, benzonatate 200 mg one capsule by mouth TID prn, guaifenesin ER 600 mg, Tussionex 10-8 mg/5ml, and Vitamin D 2000U.

Pfizer dose 1 - left arm hurt for 3 days - used ice pack and Advil to ease Pfizer dose 2 - started bleeding upon receiving the vaccine. Left arm again hurt the evening of the shot. Next morning I was in a lot of pain and my arm had a red ring and lump. Very tender. I also had a mild headache which turned into a migraine in the evening. Third day after vaccine my arm still hurts and the red ring has grown in size and mildly itches. (As I type I am in day 3).

Could feel that I went into AFIB about 10 minutes after shot administration. Nearly 5 hours later at time of submitting this report I am still in AFIB.

Mild/moderate anaphylactic reaction lasting about 45 minutes, trouble swallowing, fast pulse, disorientation, tight throat. Epinephrine not used.

I got the shot on Friday then had a low grade fever on Saturday, was fine until Tuesday, 3/30, when I had a cardiac arrest event and my heart stopped beating. I needed CPR to be revived.

Was talking with husband and commented that I felt a wave of tired coming over me. Immediately following the statement I was having difficulties speaking, slurred speech, and my body felt weighted. This lasted 2 minutes. This experience happened two more times so we left for the ER. Another episode happened while checking in the ER and they responded as if I was having a stroke. A 5th episode happened while in the ER waiting for a room and a 6th time after admission in the room with a nurse. This last episode was at 1:00pm on 3/5/2021. I could feel each of these coming on.

Patient developed L sided weakness and numbness on 4/15/21, and was found to have a transient ischemic attack.

Started cramping about an hour after. Then 2 hours later started having bright red breakthrough vaginal bleeding. I am not sure for my chucks for another 8 days and was not bleeding prior to vaccine not cramping.

I passed a number of large blood clots (the size of a walnut) from my body on the two days after I received the shot. The day that I got the shot coincided with the day that I got my period, so I was already menstruating when the clots passed from my body. The clots were much larger than normal, and much more frequent. I passed almost a half dozen large clots. By the third day, my menstruation flow started to subside (the first two days tend to be heavier days for me). I did not pass any large clots on the third day going forward.

bleeding; have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding; have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) via unspecified route of administration on arm left at a SINGLE DOSE on 06Apr2021 15:15 for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 16Mar2021 14:15 for COVID-19 immunization. The patient had no relevant medical history. Patient received other medications in two weeks are Lisinopril and LEVONORGESTREL (mirena). On 10Apr2021 patient use an iud for birth control and have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding. Patient didn't received treatment for the events. The clinical outcome of the events not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

The day after the vaccine I experienced brain fog, fatigue, and sore arm. I also got my period. I have a history of painful periods but after an endometrial ablation over 10 years ago I have had normal pain. The period after the vaccine was incredibly painful and the consistency of the discharge was completely different. Pale pink clots that almost looked like uterine lining instead of clots I'm used to seeing. I want to report this because I've talked to other women who've had something similar but I didn't see anything about it on the CDC website.

problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top of my head and my hands hurt; Nauseous; my hands and feet started going numb; they itch they burn; feet are painful; uncomfortable; blood clot/a clot or something in her legs; from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein; she thought she was having a stroke; cramps; burning from my calf to my feet; pain in her neck then to her back; pain in her neck then to her back; different temperatures like hot and cold make it bad and irritating; can't sleep well because of her symptoms; Swelling in her Feet; can't think right; This is a spontaneous report from a contactable consumer. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in the right arm in the morning of 01Apr2021 (Batch/Lot Number: ER8727) as a single dose for COVID-19 immunization. Medical history included ongoing complex regional pain syndrome, ongoing fibromyalgia, ongoing arthritis - all diagnosed 20 years ago. Her mother has lupus and rheumatoid arthritis and she can't have the vaccine, states she doesn't know if something could be genetic. Low potassium in the past and stated that she has a lot of allergies to medications, but she consulted with the pharmacist and he said it would be okay. There were no concomitant medications. No additional vaccine was administered on the same date of BNT162B2 and no prior vaccination within four weeks. The patient was having weird symptoms and she tried looking online and in different groups to find out if anyone has similar symptoms, but she hasn't been able to find anything. She began by saying she has health issues; she has Fibromyalgia and Complex Regional Pain Syndrome. She doesn't know if studies were performed on patients with those disorders that took the vaccine. It's been about 3 weeks since getting the vaccine (Apr2021) and she started having symptoms that she thought could be a blood clot. From the knees down, she was having a lot of pain, cramps, burning from her calf to her feet. She would keep rubbing them and massaging them. It was excruciating pain. She was having symptoms and she did go see her Nurse Practitioner on 14Apr2021 because she thought she was having a stroke or a clot or something in her legs or that she was having a problem with her cholesterol. The nurse thought maybe it was her electrolytes, because she had low potassium in the past, but everything came back normal. Her feet were painful but not as bad in Apr2021. She felt like her condition but it's flaring up like 200% it's like over a 10 on the pain scale. She can't think right, she can't work, and was very uncomfortable in Apr2021. The leg pain felt like it is really deep in the vein, it doesn't feel like it is superficial, and she can feel stuff or liquid flowing. Her pain alternates from her head to her neck to her feet and it is very uncomfortable. Her hands and feet started to go numb, not completely numb but like when they fall asleep from sitting on them and then hit something and it hurts. Her arms were burning like crazy; they itch, they burn in Apr2021. Different temperatures like hot and cold make it painful, bad and irritating, and she can't sleep well because of her symptoms. She doesn't know the exact dates, but it has been about a week, but it is changing. It started with cramps in her legs from her knees down. That is where she had injuries and she thought it was her cholesterol. From her knees down, she has cramps and pain and it is very uncomfortable, she felt a really deep pain. She has pain in her neck then to her back, it started in her lower extremities and it is going up. It has stayed the same and she has to keep taking Tylenol to control the pain. Her symptoms got worse and she started taking Tylenol and that helped and then on 15Apr2021, her hands and feet started going numb and she had a headache and pain on the top portion of her head (reported as brain) and her hands hurt, and she was nauseous. She hasn't heard back from the nurse practitioner, so she decided not to go and get it done because she felt it is from the vaccine. She also has swelling of feet in Apr2021, and now she just woke up an hour ago and she slept somewhat okay, but she had to take Tylenol. Now that she is standing, it felt like her legs are starting to hurt again. Treatment included Tylenol, which helps a little and she has to keep taking it. If she doesn't take Tylenol, she can't even function. The events from the knees down I was having a lot pain/leg pain felt like it is really deep in the vein, cramps, my hands and feet started going numb, they itch they burn, feet are painful, uncomfortable, pain on the top of my head and my hands hurt/headache, swelling in her feet, nauseous, pain in her neck then to her back, different temperatures like hot and cold make it bad and irritating had not resolved, while the event can't sleep well because of her symptoms was resolving, and the outcome rest of the events was unknown.

First shot 12/23, 2nd 1/12/21. A week after #2 my menstrual cycles (which have been clockwork all of my life-I have 4 children and track it monthly) became much more frequent and heavy with excessive clotting. I thought perhaps I was going though early menopause (44) but then realized correlation with vaccine. My mood changed, I feel sad all of the time, I am dreading recommendation of additional shots.

Currently 4 days of bleeding; increased energy; sore left arm; overly emotional cry ie for a couple/few days; menstruating when I had my period only 14 days before; This is a spontaneous report from contactable consumer, patient. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration, in the left arm on 09Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, and thyroid issues. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant drugs included ofatumumab (KESIMPTA) from 30Mar2020. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ocrelizumab and experienced hypersensitivity. On 21Apr2021 at 12:00, the patient experienced currently 4 days of bleeding, increased energy, sore left arm, overly emotional cry ie for a couple/few days, menstruating when I had my period only 14 days before. The outcome of the events, currently 4 days of bleeding, increased energy, sore left arm, overly emotional cry ie for a couple/few days, menstruating when I had my period only 14 days before was unknown.

breathing labored while walking or doing activity; swollen lymph nodes/ lymph nodes were enlarged slightly; fluid built up around heart and lungs; fluid built up around heart and lungs; white blood count was elevated; heart was weak and only working at 29% percent; heart was weak and only working at 29% percent; This is a spontaneous report received from a contactable consumer (patient). A non-pregnant 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 13Feb2021 at 18:00 (at the age of 43 years old) (Lot Number: EM9809, unknown expiration) as 2nd dose, single for COVID-19 immunization. Medical history included penicillin allergy. There were no concomitant medications. The patient also received first dose of BNT162B2 on 23Jan2021 at 18:00 (at the age of 43 years old) (lot number: EL3247, unknown expiration) in left arm for COVID-19 immunization. After the second shot, the patient did notice swollen lymph nodes on 02Apr2021 for several days. She noticed her breathing labored while walking or doing activity on 02Apr2021 after getting the second shot. In 8 weeks, the patient went to the ER and found that she had fluid built up around heart and lungs which started on 02Apr2021. They also found in a CT scan that lymph nodes were enlarged slightly and that the patient's white blood count was elevated on 02Apr2021. After an echocardiogram on 02Apr2021, they determined that the patient's heart was weak and only working at 29% percent. The patient has had no prior history of heart problems or was taking any medications. The patient was given many heart medications to strengthen the heart and treatment for the events. The events resulted in emergency room/department or urgent care visit. The patient has no COVID and was not diagnosed with COVID prior to vaccination. The patient was tested for COVID via nasal swab on 10Apr2021 with negative result. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was unknown. The events were assessed as serious (hospitalization) for 8 days. No follow-up attempts are needed. No further information is expected.

Shortness of breath and pain in left abdomen. CT scan on 3/27/21 showed the following: Bilateral segmental pulmonary emboli. Findings were communicated to P.A., by telephone by Dr. on 3/27/2021 at 1:40 PM. At the request of the ordering provider, the patient was instructed to go to the emergency department for further evaluation and treatment. I, (name) MD, have reviewed the images and verify the above interpretation on 3/27/2021 2:12 PM. Electronically signed by (name) , MD on 3/27/2021 2:12 PM My treatment was to get on Eliquis, a blood thinner.

Received the Pfizer 2nd dose on 9th April. Following day (04/10), I had body ache, fatigue, mild temperature 99.8, back neck and upper arm/shoulder pain. While I recovered from the ache and fatigue the next day (04/11), the neck pain continued for a couple of weeks. On 23rd April, the pain aggravated and I took a 2 Advil's (2 tablets of 200mg each) which made the overall pain extremely critical. The pain was mainly in the neck, upper arm, tingling in the fingers, grinding jaw pain, all symptomatic to a cardiac pain. I visited the Urgent care and they suggested I rush to Emergency care. See the notes attached. I was detected with Myocardial infraction or Heart Inflammation (as there was an increasing Troponin). They did an Angiogram to detect any blockages but was cleared of all blockages or major heart conditions. Was hospitalized for 2 days and was on observation for any new pains, repeat or increase in symptoms. Heart inflammation continues to be there and I am unable to take any anti inflammatory as that aggravates the cardiac/ MI pain. No prior history of heart disease etc. Will be visiting for repeat tests with the Cardiologist in coming weeks. Since there were no prior heart condition and since this initiated day after the 2nd vaccine, i strongly believe this is a side effect from the vaccine dose.

Vaginal hemorrhage 5 days after 2nd Pfizer dose on 1/16/21. Very heavy menstruation on 1/21/21 with large clots one week prior to anticipated cycle date. Prior to event, menstrual cycle regular at 29 days and lasted 7 days from date on onset. After event, cycle shortened and then became irregular. Second menses after 2nd Pfizer began at 23 days 2/12/21, next cycle at 24 days 3/7/21 , next 34 days on 4/9/21, next to 22 days 4/30/21, next to 14 days 5/12/21.

Started with the right arm turning purple or changing colors when elevated above the head. This continued for a few weeks. Then I started to get a tingling sensation in the elbow that went into the right pinky. I visited my primary doctor to see what was going on. She did an evaluation, prescribed Ibuprofen and physical therapy, and had a cervical spine x-ray done. The X-ray looked great when it came back. I could not get an appointment with PT for several weeks so I finally went to the chiropractor on 5/13. He worked on the shoulder area stretching it out. By the morning of 5/15 I was being taken to urgent care and eventually the ER because the arm was swelling and fingers were turning blue. They did blood tests, EKG, chest x-ray, and finally an ultrasound that showed a blood clot. It was DVT in the subclavian vein. I was given a blood thinner and sent home. I had a more thorough ultrasound on 5/17 that sent me back to the ER and with vascular surgeons to discuss immediate surgery with lysis therapy. It was decided that the blood clot had probably been there for weeks and the success rate of the surgery would not be as good.

ON 01/19/2021, I HAD A SHARP PAIN IN MY LEFT CALF WHICH FELT LIKE A MUSCLE SPASM. FOLLOWING THIS I BEGAN HAVING EDEMA IN THE LEFT FOOT, ANKLE, AND LOWER LEG ASSOCIATED WITH PAIN. PAIN AND SWELLING WORSENED WITH PROLONGED STANDING DESPITE USE OF COMPRESSION SOCKS. VENOUS DOPPLER OF THE LEFT LOWER EXTREMITY OBTAINED AT MEDICAL CENTER ON 01/25/2021 SHOWED DVT. DR. ORDERED THE VENOUS DOPPLER AND THEN PRESCRIBED XARELTO FOR INITIAL TREATMENT. I FOLLOWED UP WITH MY PCP WHERE ADDITIONAL PRESCRIPTION FOR MAINTAINANCE XARELTO ANTICOAGULATION FOR A TOTAL OF 6 MONTHS WAS GIVEN.

Pt presented with angina, inital troponin normal, then rose to 5.2. Ck-MB and MB index also rose and fell consistent with MI. D-dimer was normal. EKG without clear evidence of ishcemia or pericarditis. Coronary angiogram with no culprit lesion identified (either spontaneous coronary artery dissection or thrombus). Echo did not show wall motion abnormalities or pericardial effusion. Differential for this hospitalization with NSTEMI includes myocarditis, coronary spasm, or subclinical dissection.

I experienced a muscle tension and neuroprosy. I have internal trimmers and he external arm trimmers. I've also been bleeding heavily for every two weeks.

fatigue for a few days. She went to Urgent care on 4/24 where she tested (+) for COVID. Went to hospital April 29 evening around 10pm. Discharged on April 30th around 500pm. Diagnosed with pneumonia.

I was dizzy and I checked my bp and it was 70/40 i stopped talking my bp meds, drank water and my Bp came back up and I was fine. About a week later, i was short of breath. I called my asthma dr who ordered steroids. That did not make a difference. I never really got better. I figured the vaccine triggered my asthma. In march, I felt like i was going to pass out as I was walking into work. I went to work and was short of breath the whole night I called my doctor, I kept taking albuterol and steroid thinking it was asthma related .I worked that Sunday and went to the Dr on Wednesday who sent me to the hospital. I've been on anti coagulants since then. They thought it was a female cancer, or clotting problem. I have never taken birth control in my life so i had no participating factors. There are a few labs that cannot be done until after I am off of anticoagulants. These clots are completely unexplained and I have changed nothing aside from receiving the COVID vaccine.

I am a healthy 43-year-old woman with no major medical problems and no history of cardiac disease of any kind. I received the COVID-19 vaccine on December 22, 2020 because I am a healthcare worker. Five days later, I felt palpitations and my fitness Watch recorded at least 30 seconds of an abnormal heart rhythm. I was admitted to the hospital where my treating cardiologists felt that the rhythm was ventricular tachycardia. I received an extensive inpatient evaluation including a CT angio, MRI, and echocardiogram all of which were normal. I received my second dose of the vaccine on January 11 or 12th of 2021. Two weeks there after, I had a documented episode of ventricular tachycardia on a Ziopatch. I continue to be followed by a cardiologist with an implantable recorder and have had no episodes of VT since. The etiology of my VT remains unknown but it?s timing in relation to the vaccine has prompted me to submit this report.

One hour after the vaccine I had headache, my feet were sweating, a little of wheezing and experienced fatigue. On day two my symptoms continue added nausea , cramping of my right toes and an upset stomach feeling started, also I started to feel dizzy. 6/11/21. The ER said to drink lots of fluids and sent me home. Today is day 14 and I am still sick with nausea and dizziness and anxiety. I went to my primary doctor on Thursday 6/17/21. My period arrived 10 days earlier with heavy discharge and small clots. My period ended yesterday. I am not able to drive, work or go out because I am dizzy. My body feels strange.

Patient was admitted to the hospital 4 days after the dose with gram negative bacteremia from a port infection, also found to have an infarction of the splenium of the corpus callosum on MR imaging, acute on chronic thrombocytopenia. DDx include a thrombotic thrombocytopenic process. Patient reports fevers, chills, malaise, N/V starting the morning after vaccine leading up to the presentation to the hospital.

Sudden onset headache accompanied with nausea and vomiting around noon. ER visit MRI showed grade 1 SAH at basilar artery. Transported to ICU. Angiogram negative, nonaneurysmal unknown cause. No history of high cholesterol or high BP or trauma to head.

Started with body aches, joint pain and weakness, followed by SOB that was aggravated over time- especially after the 2nd dose- Then, she started having increase heart palpitations and chest pressure. Eventually noted ischemic changes with purplish discoloration face, hands and feet. At this time it became great effort to walk due to lack of air- SOB was severe. She was taken to ER at hospital where she was admitted with possible PE, MI or heart failure. After few days no improvement was achieved and patient trans ported to another Hospital to receive more advance care but she was pronounced death in the morning of 5-11-21. The death certificate heart failure as immediate cause of death, preceded by PE and pulmonary hypertension.

8pm to 12am Chest pain and heart attack with no other cardiac history or risk factors. Evaluated at hospital. Abnormal EKG and troponin of 20. Cardiac catheterization revealed a spontaneous coronary artery dissection of the LAD. Cardiac ICU for observation and medical management. Echocardiogram revealed normal heart function despite the dissection.

DVT - blood clot, found in left leg. Symptom, leg pain, diagnosed via ultrasound at hospital , Lovenox and Pradaxa

a blood clot in the brain; Dural sinus thrombosis; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; formulation: Solution for injection, Batch/Lot Number: Not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 20May2021 14:00 (at the age of 43-years-old) as a single dose for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing. It was reported that the patient took birth control pills within two weeks of vaccination (unspecified name). 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 vaccination. On 06Jun2021 14:00 the patient experienced a blood clot in the brain, dural sinus thrombosis. The patient was hospitalized for a blood clot in the brain and dural sinus thrombosis for 12 days. On 07Jun2021 and 21Jun2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative. Device Date: 27Jun2021. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Witnessed seizure at 7:30 pm EDT on May 2, 2021. No prior medical problems. Serum sodium dropped to 117. Potassium on arrival 3.3. Continued seizure activity (second seizure after arriving in ER.) Acute respiratory failure after aspirating in ER, placed on ventilator for 5 days. Acute hyponatremia; likely SIADH component related to seizure as causative factor. Prior history of low sodium November 2018. New onset hyponatremia versus any other causes. CT head with negative findings. Hypokalemia. Diarrhea reported by nursing staff. Developed pneumonia. My mother was hospitalized with low sodium 2 weeks after receiving the second dose of the Pfizer vaccine due to low sodium of 125. My seizure took place 12 days after the second dose of the Pfizer vaccine.

Starting the day after the vaccine, I had about four days of fever to 102-103, and malaise and tiredness. Three days of fevers in the 103 and a few days more of fevers in 101. It triggered a flare of arthritis with my lupus. They treated with Prednisone and things got better in 5 days or so. In February, I had an episode of intermittent vision loss and I've experienced four total episodes of that between Feb and June 2021 each lasting about 15 minutes just in my left eye. I had a CT scan in July. They increased the Lovonox and started Acetazolamide to reduce the pressure in the brain from the clot. They are going to repeat a scan in three months. Nothing has gotten worse symptomatically.

Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushing, throat swelling, heart palpitations, trouble swallowing , feet swelling, light headed, anxiety. Hospitalized from the 12/23/20 to 12/26/2020 . Medications now on Epinephrine, diphenhydramine, cetirizine, famotidine, prednisone, lorazepam, cephalexin. on 1/1/2021 was taken to E.R. by ambulance around 11:00 am left hand was tingle started to go numb traveled up my arm into left side of my face ,ear, tongue, and then down to the left side of my leg and into left foot, could not move left side of body for a good 7 to 8 mins then went away transferred to ambulance enroute to ER blood pressure was high and and started having right ear pain and right side frontal severe headache, arrived to ER and was given diphenhydramine ,ketorolac, metoclopramide HCI, lorazepam. MRI was ordered and Neurologist found two small lesions on right side of frontal brain, following up now with neurologist. added more meds naproxen

1/6/21 8pm started with Nasuea, vomiting, diarrhea and fever. 1/7/21 started having intermittent chest pain in the morning. Then in the evening it became constant. Went to ER that evening due to chest pain. EKG showed t wave abnormality. 1st Trop was negative went from 0.08 to 2.3 Had 2 Echo's done and they were normal. Platelets were 85. Was discharged without chest pain. Troponin on discharge was 0.67 and platelets 61. Was admitted due to Chest pain and troponin. Attending provider diagnosed as myocarditis and thrombocytopenia R/T vaccine.

unsure if related to vaccine, but was notified by her next of kin that she died on 1/4/2021. No reports of side effects or hospitalization were reported to the facility prior to the notification of death.

Moderate anaphylaxis reaction per urgent care provider. Developed severe hives and swelling, fever, severe headache 2 days after vaccination. Was treated with Benadryl, Solumedrol IM, and Prednisone taper at local urgent care center.

12/23/20 - RECEIVED 1ST DOSE OF COVID-19 VACCINE IN AM FROM EMPLOYEE HEALTH CLINIC 12/24/20 EVENING - ACUTE ONSET OFSYMPTOMS HIGH FEVERS >101 - 103 F, SEVERE CONSTANT HEADACHES (PAIN SCALE AT 10), BODY ACHES, NAUSEA, FATIGUE, DIMISHED TASTE AND SMELL AND DIARRHEA SYMPTOMS CONTINUED TILL 1/7/2021 - SLOWLY IMPROVING

Visited Provider appx 500 pm 1.14.2021 DVT - left calf - 2 clots via ultrasound on Eliquis now

Provider stated patient had anaphylaxis (facial swelling) at around 2:16, 1 dose epi pen was administered and rapid response called. Patient was transported to the ed . Per providers note, developed sensation of Facial swelling, lip swelling, tongue swelling and difficulty breathing

Abnormal menstrual cycle pattern. 3 days of spotting after the first injection. Currently 15 days of spotting/light vaginal bleeding after the second vaccine. This symptom has not yet resolved.

Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0142), at same age, via an unspecified route of administration in left arm on 05Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medication included metoprolol. The patient previously took ampicillin and experienced drug allergy. The patient experienced dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side. Right side weakness. Only one eye blinks right eye droopy, all on 05Jan2021 10:00. Events resulted in emergency room visit. The patient was hospitalized for 1 days for all events. It was unknown whether treatment was received for all events. Patient is not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient underwent lab tests and procedures which included nasal swab/ covid test: negative on 08Feb2021. The outcomes of events were not recovered.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported dizziness, stoke like symptoms, she lost taste, smell, hearing, lost station on my whole right side, right side weakness, only one eye blinks right eye droopy, and the administration of the COVID 19 vaccine, BNT162B2, administration, based on the reasonable 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 RA, IEC, as appropriate.

Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itching, rash and hives. Pt PE upon arrival stated that she was in acute distress. Itching,rash,hives,swelling and redness present on pt's back, chest and left arm. Progression: worsening. Moderate severity. Pt had taken lisinopril 10 mg with no improvement. Pt was treated with steroids, H1 and H2 blockers with good response. 02.01.2021 Pt presented to ED with BP of 200/140. Pt reports BP has been elevated since receiving her COVID vaccine on 01.29.2021. Pt exam positive for tinnitis. BP @ 1253 144/98, 1152 170/107, 1130 185/112, 1126 190/124. Pt BP came down with self administered hydralazine. 02.04.21 Pt presents to Ed with elevated BP of 161/111 and chest pressure. Pt has not had relief with dose of clonidine and hydralazine. She also took a dose of steroid. Pt ROS pos for chest tightness, chest pain and leg swelling. BP improved with anxiolysis.

Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP = 180/120/her BP was high; feeling lightheaded; This is a spontaneous report from a contactable healthcare professional (HCP) (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection; lot: EN6201, expiry: Jun2021), intramuscular (IM) on left (L) arm (at the age of 44years) on 16Feb2021 at 12:00 at single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (lot: EN5318, expiry: Jun2021) IM on L arm on 28Jan2021 at 14:45 that 45 minutes after administration (on 28Jan2021) the patient experienced tingling sensation on lip which was with diphenhydramine hydrochloride (BENADRYL) as treatment and recovered on unspecified date. Medical history included hypertension, allergic to fish (treatment were adrenaline (EPIPEN), corticosteroid and antihistamine) and ongoing BP. Concomitant medications included ongoing hydrochlorothiazide, lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) and ongoing unspecified Vitamins daily. The patient previously took prochlorperazine maleate (COMPAZINE) and metoclopramide (REGLAN) which were medications she took while pregnancy, gabapentin and hydromorphone hydrochloride (DILAUDID) where the patient experienced allergies from these drugs and treatment were adrenaline (EPIPEN), corticosteroid and antihistamine. There was no covid prior vaccination and was covid tested post vaccination with Nasal Swab (Sofia SARS Antigen) on 04Feb2021 with result of negative. The patient experienced severe anaphylaxis attack on 16Feb2021 at 12:30 (30 minutes after the administration of 2nd dose) which 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) with treatment included Intravenous IV diphenhydramine hydrochloride (BENADRYL) + prednisone + famotidine (PEPCID), GI cocktail, Heart monitoring. The HCP (patient) was on observation for 30 minutes when she started with tingling sensation, sweating and feeling hot (in Feb2021). They took BP=180/120 (in Feb2021). They administered IV diphenhydramine hydrochloride + prednisone + famotidine. She was feeling lightheaded (in Feb2021). She stayed in observation for 4 hours until recovered. She was sent home and prescribed prednisone and loratadine (CLARITIN) daily. HCP stated that she has an episode yesterday (16Feb2021), she was feeling tired, the sweating came back and her BP was high. Today (19Feb2021) her BP was stable. The patient reported tachycardia under information on organ involvement (in Feb2021). The patient required medical intervention but not hospitalized nor admitted to an intensive care unit. No other vaccine in four weeks and no other medications in two weeks. The patient did not receive any recent vaccines for any other conditions prior to the events and did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the events. The outcome was recovered for the events anaphylaxis and dizziness both in Feb2021, and hypertension on 19Feb2021 while for the remaining 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 event Anaphylaxis cannot be excluded. The case will be reassessed if additional information becomes available.

very high Troponin levels (4.79 & 12.49); repeat episodes of chest pain; heart attack; thrombus formation; coagulopathy; myocardial infarction; This is a spontaneous report from a contactable nurse (reporting for herself). A 44-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# ELI283), via an unspecified route of administration single dose on 12Jan2021 for covid-19 immunisation. First dose was received on 22Dec2020 10:00 left arm (lot# EJI695). Medical history included chronic skin condition. No other vaccine was received in four weeks. Concomitant medications included oxycodone for pain, colecalciferol (VITAMIN D). The patient experienced myocardial infarction on 10Feb2021 20:00, very high troponin levels (4.79 & 12.49) on 11Feb2021, repeat episodes of chest pain on 10Feb2021 20:00, heart attack on 10Feb2021 20:00, thrombus formation on 10Feb2021 20:00, coagulopathy on 10Feb2021 20:00. The patient was hospitalized due to the events from 11Feb2021. Patient reported to be a healthy 44 year old woman with no history of hypertension or high cholesterol. She was now on 7 different medications to protect her heart, including blood thinners and antihypertensives that result in daily headaches and fatigue. She had had several repeat episodes of chest pain which has required taking sublingual nitroglycerin. She was off work for an undetermined amount of time. Her primary care physician was baffled by her case and reached out to a number of experts who have agreed that her heart attack was caused by a thrombus formation/coagulopathy most definitely related to the Covid vaccines she received. The events outcome was recovered with sequelae.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of myocardial infarction and other events. However, the reported events may possibly represent intercurrent medical conditions in this 44-years-old patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG at baseline and during subject drug therapy, echocardiogram, electrolytes, chemistry panel and coronary angiogram, 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.

Pt walked up to staff c/o itchy & swelling to throat & tongue. Staff assessed pt & vitals. Pt presents with anaphylaxis & hypertension. Staff gave ALS care and administered 50mg Benadryl IM & EPI 0.3 mg IM. Due to no improvement, staff gave O2 prior to 2nd EPI dose. Staff transported pt to Hospital. EOR.

Woke up with sore upper right thigh Tuesday March 9. Very tender to the touch. Visited Dr. Wednesday March 10, ordered ultrasound which was completed on Thursday March 11 and diagnosed a superficial blood clot. Prescribed Xarelto 10mg.

I thought was a sinus infection exp wheezing, headache, achiness. By week two went to ER got tested diagnosed with pneumonia was prescribed two inhalers. On week three started running fever even after two antibiotics.Im recovering still exp shortness of breath at times.

First Vaccine Dose on 12/26/2020 felt extremely fatigued. After 2nd vaccine dose on 01/16/2021 developed fever, chills, weakness, fatigue, body aches approximately 10 hours after received the 2nd dose. This all lasted about 24 hours. Then on 01/19/2021 which was the 2nd day of mine menstrual cycle, I had a very abnormal menstruation. I was passing "fist" size blood clots which made me very weak. this lasted again about 24 hours then it stopped. I had some labs drawn on 02/27/2021 which came back with very low Iron, Hematocrit and Hemoglobin levels. I usually do show signs of anemia in previous blood work but this time the levels dropped lower so i was referred to see a Hematologist.

Vaginal bleeding beginning immediately after first shot. 2 days after second shot vey heavy/hemorrhaging vaginal bleeding. Went to ER. Ultrasound & bloodwork all ok. Following up with gynecologist this week.

Immediate metallic taste in the mouth. Anaphylactic reaction starting after 5 minutes (high heart rate, difficulty swallowing, tight feeling in chest).

Anaphylaxis; This is a spontaneous report from a two contactable consumer (patient and office assistant). A 44-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208), via an unspecified route of administration in left arm on 12Mar2021 at 18:30 as a single dose for COVID-19 immunization. Medical history included hypothyroidism, bipolar and high blood pressure. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was unknown if patient had covid prior vaccination. Concomitant medication included lamotrigine (LAMICTAL), levothyroxine (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and glucosamine (MANUFACTURER UNKNOWN). On 12Mar2021 at 18:45, the patient experienced anaphylaxis. It was reported that patient visited emergency room/department or urgent care. The patient took Benadryl and 2 epinephrine shots as a treatment. It was reported that COVID test was not done after post vaccination. The outcome of the event was resolved on Mar2021.

20 minutes after injection, started feeling itchy all over. Began coughing and having asthma, used inhaler twice with no relief, was taken from coliseum by ambulance to ER. Enroute given epinephrine and 50 ml of benadryl. At ER repeat epinephrine and benadryl, H1/H2 blockers given. Released after three hour observation. Diagnosis of anaphylaxis.

Patient presents 1 day after anaphylactic reaction (throat swelling, congestion, hives, nausea, SOB) after running outside around a lake. No previous history of anaphylaxis or allergies. Reports that she had her COVID-19 vaccine 1 week ago. and had question about if that could have contributed to the event.

Slight vaginal bleeding 2 days after receiving the first dose of the vaccine (1 bleeding only) On the fifth day after receiving the first dose, my menstrual period was early (Which is unusual because I am very regular)

24 hours after receiving the 1st dose vaccine I suffered from abdominal pain/cramping and vaginal bleeding. The vaginal bleeding was heavy at times and lasted for 60 hours. The abdominal pain continues as I fill this report out which is currently 72 hours. I was seen today by a gynecologist who performed a pap smear and ordered an ultra sound.

Vaccine administered around 0850, approximately at 0854 patient notified provider with symptoms of anaphylaxis reaction. Patient brought to private room, notice symptoms of generalize rash. Vital signs taken at 0902 BP: 142/82 HR:102 O2: 100%. Administered Benadryl 50mg/mL at 0902 Lot number: 6020111 Exp: 07/21. Patient expressed tightness of throat with audible wheezing, immediately administer EPI Pen 0.3 mg/mL Lot number: 0FN1407 Exp: FEB2022 on the left thigh. Patient improving symptoms. FED FIRE was called at 0901, arrived at 0908, transported at the Hospital at 0912.

nausea; vomiting; chest pain; myocarditis; thrombocytopenia; This is a Literature-spontaneous report 2021, 1-4; entitled Thrombocytopenia following Pfizer and Moderna SARS-CoV-2 vaccination. A 44-year-old woman was hospitalized for nausea, vomiting and chest pain on the day that she received the Pfizer vaccine (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) at single dose (at 44-year-old) for COVID-19 immunization. Her laboratory values included a platelet count of 85 x 109/L and a peak troponin level of 4 ng/mL (normal < = 0.04 ng/mL). The patient was diagnosed with myocarditis but did not require treatment for thrombocytopenia. Her platelets were 61 x 109/L on discharge, but subsequent platelet counts were not reported. The outcome of the events was unknown. No follow-up attempts are needed. Information on Lot/batch number cannot be obtained.; Sender's Comments: The causal association cannot be excluded between the reported events and BNT162B2 vaccine use. 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 AE. 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.

Pulmonary Embolism. Emergency open heart surgery. Coded for 4 minutes. In ICU and Hospital. Kidney failure.....Total blockage of left lung. 9 inch clot in right ventricle.

About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went completely numb and tingling. Scalp tingling and numb. Felt like circulation was cut off. Severe Shortness of breath. Extreme feeling of adrenaline. The next day on March 14th, had extreme vaginal bleeding on day 14 of cycle. Bled for another 7 days which led to extreme anemia. The shortness of breath is every day since the first dose. Heart palpitations (heart rate went up to 190!). After the second dose on 4/03, all symptoms got worst. Left leg went completely numb the same day which I went to the emergency room for. The neurological tingling and numbness was spreading to my whole body. Arms, legs, face, ears, scalp, inside my head. I was worried for a heart attack since all of my symptoms of left arm and shoulder pain and numbness etc. I was released from the emergency room 12 hours later. I continued to have severe symptoms. The shortness of breath was so bad that I didn't sleep for 2 nights straight because my oxygen would drop. I also had severe insomnia and no appetite and lost 5 pounds in 1 week. Major adrenaline feeling. I went back to the emergency room 2 more times this week to check out my heart and lungs. All of my doctors recommended ER since they couldn't help me. My neurologist said he is getting lots of these symptoms from people post vaccine. My shortness of breath and elevated heart rate and numbness and tingling are still here and I can barely go up and down stairs without being out of breath and having a 130-140 heart rate and super low blood pressure and night sweats. It is awful.

Blood clot. Right leg. Treatment Lovenox injections and Pradaxa blood thinner medication. Time on Pradaxa to be determined on resolution of blood clot.

Hemorrhage like bleeding, soaked up 4 maxi pads within a 30 minute span. Expelled Blood clots the size of apples. Went to ER. Blood loss and clots resembled the look of a miscarriage, but pregancy test, can back negative. Multiply tests were ran. This carried on from 1:30 to 8pm, when fentaNYL and omipaque was given for pain. Blood Pressure was also high 154/119 and temp 99.

What: Anaphylaxis reaction. Vaccine administered around 0850, approximately at 0854 patient notified provider with symptoms of anaphylaxis reaction. Patient brought to private room, notice symptoms of generalize rash. Vital signs taken at 0902 BP: 142/82 HR:102 O2: 100%. Administered Benadryl 50mg/mL at 0902 Lot number: 6020111 Exp: 07/21. After administration of Benadryl patient expressed tightness of throat with audible wheezing, immediately administer EPI Pen 0.3 mg/mL Lot number: 0FN1407 Exp: FEB2022 on the left thigh at 0903. Patient improving symptoms. FED FIRE was called at 0901, arrived at 0908, transported at the Hospital at 0912. When: Shot given at 0850, reported symptoms at 0854 Why: Reaction to Pfizer COVID-19 first dose ( Lot number: ER8729 Exp: 07/2021) Patient has history of anaphylaxis reaction.

Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; This is a spontaneous report from a contactable consumer (reporting for herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 20Mar2021 (Batch/Lot Number: Ep-7534) as single dose for COVID-19 immunization. Medical history included seasonal allergy, asthma, and known allergies: penicillin. Concomitant medication included fexofenadine hydrochloride (ALLEGRA); montelukast sodium (SINGULAIR); amlodipine. all taken for an unspecified indication, start and stop date were not reported. The patient previously took grastek for immunomodulatory therapy and experienced drug allergy; bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En-6198) on 27Feb2021 for COVID-19 immunization. On unspecified date the patient experienced itching all over, coughing, asthma, anaphylaxis. The patient received 2 doses of epinephrine, 100 ml benedryl, and h1h2 bloc. The outcome of the events was recovering. The patient was not tested post vaccination and did not has COVID prior to vaccination.

massive clots; Pulmonary Embolisms; Occluded Left Lung, Right Ventricle; Occluded Left Lung, Right Ventricle; This is a spontaneous report from a contactable consumer (parent). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration administered in the right arm on 15Mar2021 13:45 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. The patient is not pregnant at the time of vaccination. The patient has no known allergies and has not had COVID prior to vaccination. Concomitant medications included gabapentin, carbamazepine (TEGRETOL), fluoxetine, colecalciferol (VITAMIN D), fish oil, and baclofen. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. On 30Mar2021 06:00, the patient experienced Pulmonary Embolisms, Occluded Left Lung, Right Ventricle and had emergency open heart surgery to remove massive clots. He coded for 4 minutes and was in ICU for 9 days. The patient was hospitalized due to the events on an unspecified date for 12 days. The events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), and Disability or permanent damage. Treatment for the events included open heart surgery. The patient underwent COVID test post vaccination via nasal swab on an unspecified date with unknown results. The outcome of the events was recovered with sequelae on an unspecified date. Information about lot/batch number has been requested.

I had a seizure and fell out of bed between the night of March 12th and the morning of March 13, 2021. I injured my face badly as well as my eye. I had to go to the Emergency room here on 3/16/21. I had a second seizure at the entrance to event on Saturday March 27, 2021 . It was a grand mal, clonic-tonic seizure. I was life flighted to Medical center on March 27, 2021 I was not discharged until 3/31/21.

left sided hemiplegia, found down 4/20 @3:30pm, found to have left ICA territory stroke with M1 occlusion, outside of window for tPA and thrombectomy, underwent decompressive hemicraniectomy

I started having right leg swelling. I noticed a small red spot on my medial side of my knee. I had this for about a week and then the swelling went down. A few days later, I had redness, skin was warm to touch, and hardness developing where the red spot was. I went to urgent care and the NP sent me to the ER for a possible blood clot. I had a venous study done in the ER and it was determined I had a superficial blood clot and was started on ASA 325 mg daily x7 days. I followed up with a vascular doctor and it was determined the clot was worse and had clotted all the way up the vein into my thigh. It remains superficial in nature at this time. I was started on Xarelto 10 mg daily x1 month. I follow up with vascular in 1 month to make sure the clot is dissolving. I was instructed to Follow up with either the doc or go to the ER with worsening symptoms.

Changes in menstrual cycles including heavy bleeding, large blood clots, longer cycles, and spotting between periods. This has continued for four months since receiving vaccines (I?ve completed the series now).

Patient received first dose of Pfizer COVID-19 vaccine on 1/21 at 1011. She presented to the ED that evening around 2100 due to concerns for allergic reaction. Pt reports the reaction started around 1930 after eating and consisted of nausea, throat tingling, facial swelling and chest tightness/SOB. Oral diphenhydramine was self-administered. In the ED, she was given IM epinephrine and IV methylprednisolone with good response. Was discharged home about 2 hours later with prescription for epinephrine autoinjectors. Pt reports no new foods were consumed that day therefore, reaction likely vaccine related. Pt advised NOT to receive second dose.

1/28/2021-swollen lymph nodes and pain to left side of chest and injection site. This pain continued and I went to Dr. on 4/06/2021. Dr. treated me with Toradol and Tylenol#3. Schedule me to have a mammogram and ultrasound on 4/20/2021. This is when it was discovered I had a clot in left arm. Currently being treated with blood thinners(Eliquis).

Pt presented to ER 1 hour after receipt of 2nd Pfizer vaccine, presenting with angioedema/anaphylaxis, In ER received epi, racemic epi, solumedrol, mamotidine, benadryl, then intubated and moved to ICU. Was hemodynamically stable, unremarkable airway pressures.

Morning of April 03, 2021 I woke up with swollen, itchy, burning eyes and pain in hands. I took an Allegra and went to the vaccination center. The Head nurse sent me to the Urgent care. During the exam I developed tightness in chest and throat started to swell. Doctor determined it was a delayed analphylactic reaction to the COVID vaccine. It was delayed due to taking the Allegra the previous day. He treated me with a benedryl shot and famotidine and prednisone in pill form. Observed for 1 hour and allowed to go home. As of April 5, 2021, still experiencing tightness in chest. Swelling in face has reduced

Thrombocytopenia detected through monitoring CBC. Normal platelet counts for 5+ years Normal platelet count 2.5 weeks prior to vaccination. Low counts (69k) detected 1 week post vaccination Count of 42k detected 1.5 weeks post vaccination. Prednisone treatment started. Counts have partially responded to prednisone treatment. Patient is still receiving treatment 4 weeks post vaccination

Pneumonia due to COVID-19 virus ; Had a lot of headaches; Had agitation/palpitations; Had muscle cramps; Hydroxyzine HCL; Amoxicillin; Acetaminophen.

Within less than 36 hours after receiving the 1st dose pf the Pfizer Vaccine, I suffered a Grand Mal Seizure . I was treated in the ER and followed up with my Neurologist. Dr. prescribed high dose of anti-seizure medication to take prior to Vaccine #2 on 5/16/2021

Same evening immunization felt hives and wheezing (4/15) which lasted through 4/17. Then on 4/18 started to notice pain and swelling in volar surface of the ipsilateral forearm - unclear at time if it was related Was then evaluated in the office, noted to have palpable mass in volar aspect of ipsilateral forearm. duplex ultrasound showed possible mass but no clot. Follow-up ultarsound showed possbile AVM and finally MRI showed no etiology to explain the mass. repeat ultrasound described it as vascular) HIT antibody was weak positive (at 0.4) In the interim, multiple d-dimer tests were normal, but one drawn simultaneously was elevated (possible specimen issue), and there was also an transient thrombocytopenia which we understand has completely resolved. Currently, hematology + allergist referrals are pending.

pt received 1st pfizer covid shot at 3:47 pm. she told me she had a history of anaphylaxis to oral benadryl and i counseled her that she should wait 30 minutes for observation after the immunization. around 4 pm she notified my technician the outside of her throat was starting to feel hot and itchy. i took her into the room and sat her down in private. I gave her an ice pack to put on her throat and was observing her when the itching started on her abdomen. I advised her she was having an anaphylactic event and she denied me calling ambulance or using epipen. Around 4:05 pm she asked for some cream so we gave her some hydrocortisone cream OTC that she applied to itchy area on chest and throat and she said she was feeling better. Around 4:15 she told me the itching was starting inside her mouth and allowed me to call 911 and administer one dose of epinephrine 0.3 mg in her left thigh. The fire department came around 4:20 and started talking to her and taking vitals. blood pressure was 146/90 and heart rate was 100 even with the epinephrine causing her to shake. They advised she wait for emt's that arrived around 4:30 pm and they conviced her to go in the ambulence to the hospital even though she was feeling fine since there was a chance the epi would wear off and she would need more help.

unprovoked DVT of Right lower leg; This is a spontaneous report from a contactable physician. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in Arm Left on 15Apr2021 14:00 (Batch/Lot Number: ER873I) as 1st dose, single for covid-19 immunization. Medical history included Crohn's, HTN and ADHD. Concomitant medications included spironolactone and alfetamine aspartate, alfetamine sulfate, dexamphetamine saccharate, dexamphetamine sulfate (ADDERALL).CHLORPERAZINE EDISYLATE]) and experienced allergies. The The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took prochlorperazine (COMPAZINE [PROpatient experienced unprovoked DVT of right lower leg on 23Apr2021 08:00. The event resulted in Doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of unprovoked DVT of right lower leg including Xarelto 15 mg bid. The outcome of the event was not recovered.; Sender's Comments: The reported deep vein thrombosis leg was more likely an intercurrent disease, and less likely related to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). 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.

20 minuted after getting my second dose I started having an anaphylaxis reaction. My throat became itchy, sore and started to feel tight. I took 3 doses of benadryl to help calm the symptoms as I did not want to get stuck paying for an emergency room visit or use my EpiPen which would also result in an ER visit. Soon after, I also started feeling extremely itchy all over but mainly at injection site. My body became tingly and I had hot and cold flashes. About an hour after that, the headache, nausea and horrible body aches began. the itching at injection site stopped after 2 hours but the rest of the symptoms remained for 3 days with the exception of the headache, nausea and body aches which still remain and no amount of over the counter medication help.

Immediate exhaustion Insane food cravings ( I never crave anything); followed by unprecedented blood loss. Its been so many days that I am weak and tired. I am horrified by the long term, so much so that I refuse to get the second dose scheduled for today. This should NOT do this to the female body! You should all be ashamed. Eight women I know have the same experience.

blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right; Head felt weird; Felt Cold; lightheaded; This is a spontaneous report from a contactable consumer reporting for herself. A 44-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 22Apr2021 at 11:30 (Batch/Lot Number: EW0171) as a single dose for COVID-19 immunization. There were no additional vaccines administered on the same date and no vaccination administered in the 4 weeks prior. Medical history included ongoing Hashimoto's Thyroid (diagnosed with this condition many, many years ago). There was no relevant family history. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 01Apr2021, Lot Number: ER8737; in right arm. On 22Apr2021, about a half hour after the shot she states her head felt weird, she couldn't swallow, she felt cold, and she could not breathe right. On 23Apr2021, she was driving her husband and blacked out. Her tongue also began to swell. She just happened to be by the exit ramp to the hospital. She visited the Emergency Room. They told her she was having a delayed anaphylactic reaction. No relevant tests were performed according to the reporter. All of her symptoms recovered when she started prednisone on 23Apr2021. She was prescribed prednisone, taper dose with last dose 27Apr2021. She still remained with lightheadedness and still could not drive. The only one persisting was the weird feeling in her head, almost like a lightheaded feeling. She could not drive due to this symptom There was no physician office visit for the events. The events delayed anaphylactic reaction, blacked out, tongue swelled, couldn't swallow, couldn't breathe right, and feeling cold were resolved on 23Apr2021. The lightheadedness and head felt weird were ongoing (not recovered).

I started bleeding vaginally 2 days after the first dose but it was time for my period so I didn?t think anything more. After having a normal period I continued spotting for 3 weeks. Some more than others. I then got my second dose on 5/7/2021 ( lot EW0167 ) and starting bleeding again like a period and I now have been bleeding and/or spotting for over 4 weeks. ( still bleeding lightly as of today 5/16/2021 ). Not sure if it is related to the vaccine but this has never happened to me before.

On the afternoon of 2/5/21 I developed dizziness, right hand numbness/weakness, difficulty speaking while at work. On 2/7/21 and 2/8/21 I noticed difficulty in writing so I called my PCP who ordered a brain/spine MRI for 2/12/21 which showed a right cerebellar subacute infarction, occupational therapy for right hand weakness/writing deficits, mostly resolved (~95% resolved)

ITP - platelets of 3; severe thrombocytpenia; This is a spontaneous report from a contactable physician. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Apr2021 at single dose for covid-19 immunisation at the age of 44-year-old. The patient medical history and concomitant medications were not reported. No any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Idiopathic thrombocytopenic purpura (ITP) - platelets of 3 and severe thrombocytpenia, both on 30Apr2021. The events were reported as serious with seriousness criteria of hospitalization (from an unspecified date in 2021). The events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included platelet count: severe thrombocytpenia/ITP - platelets of 3 on 30Apr2021, Nasal Swab: negative on 30Apr2021. Treatment received for the events that included intravenous immunoglobulin (IVIG), IV steroids. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported Idiopathic thrombocytopenic purpura and severe thrombocytopenia and the use of BNT162B2 cannot be fully excluded. There is limited information available, thus precluding further assessment. 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.

pt says she had a hot red swollen right leg that was very painful. On 4/16/21 she went to the Hospital ER. She had blood test and was given an US of the right leg where they found 2 blood clots. She was started on blood thinner. She was discharged and told to FU w/ PCP. On 4/21/21 she saw the doctor. She increased the blood thinner because she found a abdominal hematoma this size of two grapefruits. On 4/25/21 she was having trouble breathing and her leg was red and inflamed. She went back to the Hospital ER they thought she was having a pulmonary embolism. They did more blood work and chest x-ray. She was given Lovenox shots and took her off the blood thinner. She was discharged to go home and give herself these shots. On 4/27/21 she had a reaction to the Lovenox shot so she called her PCP. She saw the doctor on 4/29/21 she was told to continue using the Lovenox. She went back to Dr. on 5/4/21 and she was taken off Lovenox and put back on blood thinner Eliquis with doubled dosage. She was monitored. On 5/8/21 both of her legs were red and swollen and she went to her Doctors office. They did a blood test and was sent home. On 5/10/21 she went back to her PCP. Dr. office where she was sent to Hospital ER for direct admit. They did another US and a CT. They found she had blood clots in both legs. She was given IV fluids, antibiotics, was given heparin and taken off Eliquis. On 5/13/21 she was given warfarin along w/ heparin. She was discharged on 5/16/21. She still has pain and redness in both feet and legs and has been diagnosed w/ Cellulitis. She is now taking Oxycodone and Coumadin. She will see her PCP on 5/21/21.

Started with chills, fever, body aches, shortness of breath and headache for about 36 hours. The shortness of breath didn't subside so went in to see the NP at my family doctors office. She had me go get some blood work and chest x-ray. My d-dimer was over 2000 so she sent me to the ER where they did a CT Scan and found blood clots in my lungs. They then admitted me for the night on a heparin drip and then discharged me with Eliquis blood thinners. Meeting with my family doctor next week for more information.

have had off and on spotty bleeding but no monthly period; ringing in her ears; nausea; fever; eat half of what she normally ate; have had off and on spotty bleeding but no monthly period; anaphylaxis reaction; throat to stop feeling like it was closing up; severe headache; sinus pain that felt like someone punched her in the face; all over tingling sensation 20 minutes after getting the shot; chills; This is a spontaneous report from a non-contactable consumer (patient) via COVAES. A 44-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 18Apr2021 13:15 (Batch/Lot Number: ew0151) as 2nd dose, single dose (at the age of 44-years-old) for COVID-19 immunisation. Medical history was not reported. The patient did not have any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not have any other medication within 2 weeks of vaccination. The patient has not been diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient received his first dose of BNT162B2 on the left arm on 26Mar2021 17:30 (batch/lot number: er8127) for COVID-19 immunisation and experienced extreme structural pain and severe flu like symptoms for 4 days. The patient reported that on the second shot, she had anaphylaxis reaction along with severe headache, sinus pain that felt like someone punched her in the face, and all over tingling sensation 20 minutes after getting the shot. She had to drink 3 doses of BENADRYL for her throat to stop feeling like it was closing up. She then had ringing in her ears, nausea, fever, headache, and chills for 3 days. Since then, she can only eat half of what she normally ate. She has felt nauseated for a month and have had off and on spotty bleeding but no monthly period and a lingering headache that will not go away. The patient has yet to see her doctor due to COVID restrictions. The patient recovered from chills on an unspecified date. The patient has not recovered from headache. The outcome of the remaining events was unknown. No follow-up attempts are possible. No further information expected.

bleeding; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (BNT162B2), first dose on 16Apr2021 (lot no.: ER8735) and second dose administered in left arm on 07May2021 14:00 (Lot Number: EW0167); at the age 44-year-old both via an unspecified route of administration single dose for COVID-19 immunization. Medical history included Diabetes type 2. Concomitant medications included metformin; sitagliptin (JANUVIA); and multivitamins. The patient previously took acetylsalicylic (ASPIRIN) and experienced allergy. On 18Apr2021 at 12:00, the patient started bleeding 2 days after the first dose but did not think anything of it because she was due to start her period. After her period ended, she continued spotting for 3 weeks some days more than others. She received her 2nd dose on 07May2021 and started bleeding again like a period. And it has not stop as of today (16May2021). There was no treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.

Developed a R ICA acute thrombus (seen on CTA) and arrived with significant left sided weakness as a code stroke on 6/5. Received tPA and went for thrombectomy to evaluate the acute R ICA occlusion further which was found to be patent (thought to be due to tPA effect). After tPA, pt has complete resolution of weakness. MRI brain found a R striatum acute infarct. Pt was on an estrogen oral contraceptive medication, nonsmoker. Healthy with no hematologic conditions (no prior bleeding or clotting issues). No chronic medical conditions and healthy (would run 6 miles a day, etc), on no other medications or over the counter supplements.

Headache, falling to ground, passing out going to ER. They did an mri which showed I had an ischemic stroke.

Anytime I exerted myself it get worse so I went to the hospital and they admitted me because they couldn't control my angina; Bypass had developed a huge blood clot; Hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed.; Chest Pain; Nose bleed; Light headedness/light headed and dizzy; Hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed.; Hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed.; My arm hurt; This is a spontaneous report from a contactable consumer (reported for herself) via the Pfizer sponsored program. A 44-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left upper on 07Apr2021 (Batch/Lot Number: ER8735) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 44 years old. Medical history included coronary artery disease, Microvascular disease, migraine, Bypass of LAD artery with my LIMA artery, angioplasty, had open heart surgery before, all from an unknown date and unknown if ongoing. Historical vaccine included first dose of Pfizer COVID-19 Vaccine on 10Mar2021 at the age at vaccination of 43 years old (got the first shot in right upper arm) for covid-19 immunization. Concomitant medications included clopidogrel bisulfate (PLAVIX); lisinopril; amlodipine; rosuvastatin calcium (CRESTOR); fluoxetine hydrochloride (PROZAC); clonazepam (KLONOPIN), Nexletol (further clarification unknown). The patient experienced anytime i exerted myself it get worse so i went to the hospital and they admitted me because they couldn't control my angina on Apr2021 with outcome of unknown, bypass had developed a huge blood clot on Apr2021 with outcome of unknown, chest pain on 19Apr2021 with outcome of not recovered, nose bleed on 08Apr2021 with outcome of recovered on unknown date, light headedness/light headed and dizzy on Apr2021 with outcome of unknown, hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed (hematoma) on Apr2021 with outcome of recovered on 19Apr2021, hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed (Bruising of arm) on an unspecified date with outcome of unknown, hematoma on her arm a couple of days later after that she got it was swollen, bruises she got nose bleed (Swelling arm) on Apr2021 with outcome of unknown, my arm hurt on Apr2021 with outcome of unknown. The patient underwent lab tests which included lipids: unknown (had lipid channel), something checking for heart stress: unknown, both on unknown date. Therapeutic measures were taken as a result of angina attack, chest pain, nose bleed, hematoma, Bruising of arm, Swelling arm and Pain in arm. Seriousness for events "anytime i exerted myself it get worse so i went to the hospital and they admitted me because they couldn't control my angina" and "bypass had developed a huge blood clot" was hospitalization, medically significant. The patient was hospitalized for both events from 20Apr2021 to 23Apr2021. Events chest pain, Light headedness/light headed and dizzy resulted in Emergency Room Visit. Additional information: Transferring agent stated, "I have patient on the line today and the reason for my transfer today is that she is having adverse effects from the COVID-19 Vaccine, she did clarify it is the Pfizer COVID Vaccine and she is experiencing hematoma on her arm a couple of days later after that it was swollen, bruises she got nose bleed as well and on 19th April that she was experiencing chest pain she went to ER and they were thinking it was cause of the COVID Vaccine as well." Consumer stated, "On 07Apr2021, I have the LOT number and everything of the vaccine I received for both of them on 07Apr2021, I got the Pfizer the second Pfizer shot and I developed a hematoma on my arm which was as big as a baseball. It was really swollen and I take blood thinners and on the next day on 04-08, I started getting a lot of nose bleed. I never get a nose bleed and so I called my doctors and asked what should I do and she said stop taking your blood thinners so I stopped taking the blood thinners and then may be after 7 days, I started taking my blood thinners again. So, it took about 3 weeks for the hematoma to go away on 04-19th, I had a huge chest pain, I have had open heart surgery before and I had to go to the ER because I felt light headed and dizzy. My arm hurt, my chest, I took nitroglycerine (treatment) and it made still little better but anytime I exerted myself it gets worse so I went to the hospital and they admitted me because they couldn't control my angina and my cardiologist did an angioplasty (Further clarification unknown) and he found that my 2019, I had a bypass of LAD artery with my LIMA artery (Medical History) and he found that my bypass had developed a huge blood clot and failed. So, basically I am looking at go in and having another bypass using my LIMA artery but the surgeon, the coronary surgeon that I talking he wanted me to call Pfizer to let you guys know because he said that that is so weird that it failed and the shot and everything and he just wanted you guys to be aware and you know that's what we wanted safety because I know that when I went in I had a lot of a questions and none of my doctor could answer. It says I shouldn't take it if I am on blood thinners but they said it is still better than you getting COVID so I went ahead and took the shot but actually now I have to get a bypass again. It might be from the vaccine, it might not be from the vaccine but the timings is just you close together there." Patient took Nitroglycerin, she was on now but that's because of the chest pain so that was on before she had the chest pain when she had the shot (Further not clarified). When probed of the event is still ongoing: Consumer stated, "Yes, because my By pass graph is now failed." Treatment: Patient took Tranexa (name not clarified). It was a medicine for her chest pain. Outcome: Consumer stated, "As in nose bleed and bleeding are gone, now it is just chest pain". Follow-up attempts are completed. No further information is expected.

Acute pericarditis (confirmed by ECG, Echocardiogram and cardiology consultation), 1 week after second dose. Patient was treated with Colchicine and Indomethacin and improved. She is fully recovered. No complications.

Patient presented to hospital on 5/28/21 after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli; DVT/PE; Patient presented to hospital on 5/28/21 after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli; Patient presented to hospital on 5/28/21 after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli; This is a spontaneous report from a contactable Physician. A 44-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number unknown), via intramuscular route of administration on 22Mar2021 (at the age of 44-years-old) and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number unknown), via intramuscular route of administration on 19Apr2021 as single dose for COVID-19 immunisation. Medical history included obesity s/p Gastric bypass, iron deficiency anemia, gastritis, depression, remote history of lung surgery for empyema/lobectomy. Patient is allergic to Lanzoprazole and Vantin. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient concomitant medications were not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received her usual home medications (unspecified) within 2 weeks of vaccination. On 28May2021, the patient was presented to hospital after 1 week of right lower extremity swelling and shortness of breath found to have R sided pulmonary emboli. The seriousness of all the events was reported as serious (hospitalization/Prolonged hospitalization). The reporting physician stated that it was unclear regarding the relatedness between second dose of vaccine and the events, but the patient does not have any other known history to provoke DVT/PE. The patient underwent lab tests and procedures which included SARS-CoV-2 Test: Negative (Nasal swab) on 28May2021. Since the vaccination, the patient tested for COVID-19. The device (unspecified) date was reported as 29May2021. The patient received anticoagulation as treatment for pulmonary embolism. The outcome of all the events was reported as unknown. Information about batch no/lot no has been requested.; 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 Pulmonary embolism, deep vein thrombosis, dyspnoea and peripheral swelling cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

On June 8, 2021 I noticed right shoulder/arm pain. Went to my dr on 6/9 and he ordered a port dye study (I have a Bard Power Port for iron infusions that ended in February). The port was fine, everything flowing correctly. On 6/10, my right arm was swollen and discolored. My Dr told me to go to ER. A CT scan was done and showed 2 DVTs and 1 PE. I was admitted and started on IV heparin. I was on the IV heparin until 6/13 and then was switched to oral Eloquis 10mg twice daily. It is now 6/14, and I should be discharged sometime today. I will continue to be on Eloquis for 3 - 6 months.

large blood clot in right leg/groin, xarelto po, consult hematologist and vascular surgeon, still waiting for treatment to resolve blood clot

Patient had a reaction to the Pfizer vaccine. Patient complained of itchy throat, puffy eyelids, and anaphylaxis reaction 15 minutes or so after the vaccine was given. Patient was given EpiPen IM, Benadryl 25 mg 2 tab. Patient was stabilized onsite, then she advised to go to ER upon discharge. Patient recovered.

On the eve of the vaccine, I felt a lot of pans shooting from vaccination sight down arm, felt feverish, chills, fever was 101.0, The morning of the 22nd, I felt fine, but around 6 in the evening I got another fever, closer to 102.0, injection site still very sore, a week later I got another fever and it was around 101.5, a few days after that I started to get leg pain but the arm pain had subsided. Because I had had a surgery 5 weeks before the thought of blood clots was on my mind, I began stretches and walking but it seemed to make it worse. That leg swelled and started to change color, it was my left leg, I went to ER they prescribed Xarelto, I was told I had clotting from my side to my ankle and circulation restriction. Bloodwork showed positive results for blood clots. I still have some pain and swelling. I did walk with a limp for a couple weeks. Treatments with Xarelto will continue for 3 more months. I had a follow up at trilakes primary on 06/08/2021. She confirmed it was blood clots and said she believes it was vaccine related.

Tiredness Headache Muscle pain Chills Fever Nausea Diarrhea before going to hospital all day and at the hospital all day where i actually bled Blood pressure spiking when I normally normal it was 175/117 Loss of appetite Stabbing head pain, felt like it was going to explode flank plane

Despite completing COVID19 vaccine series in March, the oatient developed bodyaches, headache, congestion and was diagnosed with COVID(+) pneumonia. She is currently hospitalized with dyspnea and bilateral multilobal pneumonia.

COVID-19 confirmed by positive COVID-19 test; thought she had pneumonia or bronchitis; Caller states she would have reported within 24 hours, but she just did not feel well enough.; thought she had pneumonia or bronchitis; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: ER8736), via an unspecified route in the right arm on 29Apr2021 at 08:00 (at the age of 44-years) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: GN6204), via an unspecified route in the left arm on 08Apr2021 at 08:00 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jul2021, the patient experienced and went to urgent care, she thought she had pneumonia or bronchitis, they did a rapid test and the rapid test came back positive and that day, she went to the store drive-thru to get a molecular test and on 10Jul2021, the molecular test came back positive but they didn't specify if it was the variant or not. Patient stated that she would have reported within 24 hours, but she just did not feel well enough and she is perfectly healthy, she's not on any medications. The patient visited to physician office and not went to emergency room. The outcome of the events was unknown.

Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness and swelling. Went to ER, treated with IV Benadryl, Epinephrine, Famotidine, Solumedrol, Klorcon M.

COVID 19 vaccine - unsure which vaccination Flu like symptoms for 1 day with noted thrombocytopenia 127 x 10^3 Unclear if thrombocytopenia is from vaccination. No hx of this

Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment: epipen, IM Benedryl shot x2, ambulance transport to ER at Hospital for monitoring Outcome- deduced symptoms and eventual absence of symptoms 24 hours later

vaginal bleeding; This is a spontaneous report from a contactable nurse (patient) via Medical information team. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration in left arm on 08Jan2021 at single dose for COVID-19 immunization. The patient have family history of diabetes mellitus from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took Vitamin B12 [cyanocobalamin] and experienced allergy rash and levothyroxine for hypothyroidism for more than a year. The patient received the first dose of the vaccine on 08Jan2021 at 11:20 or 11:25AM and at around 3 PM, she had noticed some vaginal bleeding. She thought it was her period but it stopped during the night (she mentioned she worked that night). She asked if this was a side effect from the vaccine. It was light, like when a person's period was coming but it was a brownish color, not red. 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. No treatment given to the patient for the event. The outcome of the event was recovered on 08Jan2021.

Patient developed fever of 103 and body aches the evening of her vaccination, and continued with fever of 101-103 for the next two days. She experienced headache and nausea for the next week. On 1/22/21 she developed pain and swelling in the right middle finger at the MCP and PIP joints, and then on 1/24/21 developed pain and swelling in the L fourth finger MCP and PIP joints. She also started her period after the vaccine was given and has continued to have daily vaginal bleeding since. Her hand pain is improved slightly as of today.

In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicated so was not going through any withdrawal. She was getting vitals and CIW checked regularly. First dose of chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9. She had repeat vitals at 5:50pm, CIWA 1, vitals: P 67, 118/79, 94% on RA, T 98.3. she had complained of some "pressure in her head" and feeling anxious, but otherwise denied other complaints. she was talking with others in the group, then other patients report she suddenly started having seizure like activity around 6:45pm, med techs came to help and found her stiff, gurgling. they tried to get vitals on her, called 911, noticed that at 6:54pm she had lost a pulse and they started CPR. paramedics arrived at 7:08pm and she was brought to ED. Pt BIBA in cardiac arrest. Pt was at Detox Center when she was reported to have seizure-like activity followed by collapse. She was found to be pulseless and CPR initiated by staff members. EMS arrived and performed approx 15 min of CPR and gave pt epi x 3 and bicarb. No shocks administered but they did not report a rhythm. In the emergency room the patient arrived and was found to be pulseless with PEA arrest, CPR was initiated, patient was intubated. ROSC ultimately achieved, patient remained very acidotic despite ventilator adjustment, head CT revealed cerebral edema. Pt also found to be profoundly anemic with a hemoglobin of 5 and platelets of 37, she was thought to be GI bleeding so medications for this were initiated. Patient then became more hypoxemic with bradycardia, consultation with neurosurgery and critical care medicine at tertiary care center deemed ongoing CPR futile. Patient arrested at 2:30AM on 2/5, pronounced dead at 2:48AM.

While sitting in the waiting area I began to feel itchy. it was around 7:50am. I quickly took 2 chewable (12.5mg each) benadryl tablets. after about 5 min. i felt stable enough to leave. on the way home I started to feel the itching intensify and I felt very warm. I had welts forming and hives appeared all over. As I pulled into my driveway( 7 min drive from vaccination site) I felt my lips and eyelids swell, and my throat felt tingly. I took another 2 chewable benadryls. (12.5mg each). I immediately called my Doctor and explained what was going on. I also started to wheeze. I used my inhaler. He told me to use my epipen. Which I already had prepared since I knew this was anaphylaxis. I started to feel stable enough to go inside. I called my husband to come downstairs to be with me. I still wasnt feeling well and the tightness and wheezing persisted. At around 8:40, My dr. told me to use the 2nd Epipen and use my nebulaizer. If I wasn't better in 10 minutes he would call an ambulance. Thank GD the itching and hives subsided and the wheezing and tightness diminished by aroung 8:50am. My dr. comtinued to monitor me and check up on me. By 3pm I was back to myself.

starting that evening, I had fever to 101, headache, heartburn and diarrhea for about 30 hours. on 2/25 I had an echocardiogram that had been scheduled 3 months prior. It showed a trace pericardial effusion which was unexpected.

Patient DOB 9/21/75 sustained witnessed tonic/clonic seizure like activity with loss of consciousness lasting <15 seconds with eyes "rolling back" and skin color change from normal for age/race to pale followed by bilateral upper extremity convulsions. Witnessed by monitoring area Registered Nurse. Hx: Seizures, last seizure secondary to codeine ingestion >1 y ago. Anxiety related to injections. Timeline: 1759- Vaccinated with Pfizer Lot # EN6199 1st dose 1805- adverse reaction occurred 1806- mental status: slow to respond, skin: pale/diaphoretic, VS: HR 51 (regular at the radial site), BP 80/palp, RR: 12, T: 36.8, Spo2 100% on RA 1807- 911 activated, placed in position of comfort. 1815- EMS arrived, EKG consistent with sinus bradycardia, HR 58, BP 150/130, RR 15, Spo2 100% on RA 1820- EMS placed patient on gurney. 1825- Departed via EMS gurney

Onset of weight gain, lower extremity swelling 2/24/2021. Labs completed 3/1/2021, diagnosed with mild rhabdomyolysis on 3/4/2021 given proteinuria, myoglobinuria, elevated CK - unknown etiology/trigger for rhabdo.

Development of DVT of right leg and PE of right lung. Leg pain started on Friday 01/15/21. Care sought at Urgent Care on 01/18/21. Started on Eliquis 01/18/2021.

two weeks after vaccination, pt developed significant DVT throughout venous system of leg. Had been extremely sedentary from msk injury sustained 3 days prior to vaccine

I had my second vaccine on Monday, 3/22, and woke up at 1am on Thursday 3/25 with extreme chest pain, shortness of breath, sweating and chills. I went to the ER, and they discovered two blood clots in my lungs. I've never had pulmonary embolisms before, so this is a very strange coincidence. I am in cancer treatment, so my risk of PEs is higher, but the timing is too close for me not to think that the second vaccine traumatized my immune system, causing the PEs.

Deep vein thrombosis in right calf; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; This is a spontaneous report from a contactable physician (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 15Jan2021 (Batch/Lot number was not reported) at a single dose for covid-19 immunisation. The patient received the first dose on 29Dec2020 in the left arm for covid-19 immunisation. The patient did not receive any other vaccines in four weeks. Medical history included allergies: Sulfa. Patient was not pregnant at the time of report. The patient has not had COVID prior vaccination and was not tested post vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (SEASONIQUE) taken for birth control. The patient experienced deep vein thrombosis in right calf on 13Feb2021 with outcome of recovering. The event deep vein thrombosis in right calf resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received aspirin regimen as treatment for the event deep vein thrombosis in right calf.; Sender's Comments: Based on the information currently available, the event deep vein thrombosis most likely represents an intercurrent medical condition and was unrelated to Bnt162b2 vaccine. A possible contributory role of concomitant drug ethinylestradiol, levonorgestrel to the event can not be totally excluded. Case will be re-assessed upon the additional information provided. 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 complains of shortness of breath about 5-10 min after vaccine. BP was taken because patient stated she has high BP and a history of stroke. BP was158/114. 911 was called and ambulance arrived in 10 -15min. EMT assessed patient and asked her to smile. Patient's left face was not responding normally, Patient asked to lift both arms. Patient could not fully lift both arms. Patient transported to hospital.

45 y/o F with PMHx of vasovagal with seizure c/o not feeling well around 1:14 pm (which was 14 minutes after receiving her second dose of Pfizer vaccine). She began having a tonic-clonic seizure at 1:15 pm lasting around 90 seconds. Patient was post-ictal for approximately 1-2 minutes. When EMS and Clinical Leads were notified, patient was not actively seizing. Patient was not responsive to verbal stimuli while post-ictal. After ~3min pt was able to respond and follow verbal and tactile commands. Pt was c/o feeling tired / nauseous. Pt was AOx3 and able to follow commands. Patient was assessed by EMS and clin leads, she was placed on a stretcher, attached to monitor, vitals and BGM taken, 18g IV started on right hand and 20g IV access point attained on left hand. 15L NRB O2, 250mL NS bolus, 1L NS bolus Pt remained stable and transport was called, pt was transferred to hospital for further evaluation/workup. Pt's father accompanied pt to vaccination site and followed EMS to the hospital. 15L NRB O2, 250mL NS bolus, 1L NS bolus, 1L NS bolus started via transport Denies HA, numbness, weakness, parathesias, tingling, trauma, hitting her head, erythema/induration at injection site, palpitations, chest pain/tightness/heaviness, SOB, dyspnea, wheezing, facial or peripheral edema, cyanosis, hives, pruritis 2nd Pfizer dose administered @13:00pm, symptoms began @13:14pm, seizing began @13:15pm @1:25pm: HR 80bpm, SpO2: 100% NRB @15L @1:28pm: 3 lead: sinus arrhythmia with notched R waves in leads I, II, III, avR, avL, avF (unspecific QRS abnormality), notched p-waves in all leads, EKG not acutely concerning and patient is not actively infarcting @1:29pm: IV access with 18g @1:30pm: BGM: 99 @1:31pm: 12 lead @1:37pm: BP: 102/70 (manual large cuff on left arm) @1:42pm: BP: 80/50 (automatic large cuff on left arm) Lungs: clear to auscultation b/l, no respiratory distress, no wheezing, no rales cardiac: normal S1S2, rate, rhythm Eyes: PERRLA Throat: airway patent, no trismus Neuro: AOx3, sensation/motor/strength intact in all 4 extremities, Motor 5/5, DP/PT 2+ B/L

PT STATES 4/7 AT 3PM SHE NOTICED SWELLING IN LEG AND WENT TO ER. DIAGNOSED AS SUPERFICIAL BLOOD CLOT IN LEFT LEG. SHE WAS TOLD TO COLD COMPRESS, WALK AND ELEVATE TO REDUCE SWELLING. TODAY SHE FELT DIZZY AND THOUGHT SHE MIGHT HAVE MORE BLOOD CLOTS, SHE WAS REFERRED TO ER AGAIN WHERE THEY GAVE HER ASPIRIN 81MG AND THERE WERE NO ADDITIONAL CLOTS, HER FIRST VISIT CLOT WAS HEALING.

Patient received second Pfizer dose on 4/9 at 9:15 am. That evening she developed fever of 102.5 F with body aches and chills. On 4/10 at about noon, she developed squeezing chest tightness for about 20-30 minutes. 7/10 with back and neck tightness as well. she developed an urgent need to have diarrhea and had a momentarily loss of consciousness consistent with presyncope. Afterwards,the chest tightness went away and she felt better. All other symptoms resolved. The patient came to the clinic. Vitals: BP 97/63, P90, T36.6C, D-dimer 7140 ng/ml EKG- NSR, rate 83 bpm, no acute ST-T changes, Troponins negative, CBC - normal Chest CT with contrast negative for PE B/L LE Venous ultrasound- Right posterior tibial thrombus

Patient began to feel light headed after vaccine administration and then began to slur speech and show diminished cognitive function. Patient the stopped responding and breathing continued to diminish with lips starting to change color within 5 minutes. 911 was called. Patient was given Epinephrine 0.3 mg in left upper leg. Patient started to respond and regained consciousness. Patient continued to talk and EMT showed up 3-5 minutes later. Blood pressure was taken by them and was reported as low to patient. Was told she needed to go to hospital. They wanted to drive themselves. Patient took a bendaryl that was given to her by husband. Patient left for hospital per husband. Patient had reported fasting for the entire day. Water was given with a glucose tablet.

Severe headaches and ear pain on right side of ear. She thought she was getting migraines (but hadn't suffered from migraines in over 20 years). Went to doctor on 3/3 due to severe pain. No thoughts of what it could be. Continued headaches with no relief. Received migraine shots in hip on night of 3/11. Severe stroke on 3/13. Should not be at risk for a stroke and does not have any typical factors for being at risk. Has been in hospital and in-patient rehab since. Has a fully occluded clot in her right ICA.

Blood clot in lower right leg (calf), resulting in pulmonary embolisms and use of blood thinners. Due to fibroids, this caused excessive bleeding leading to anemic condition and the need for several blood and iron transfusions. Solution was to perform hysterectomy to eliminate fibroids and bleeding to be able to continue use of blood thinners for blood clot condition.

I'm on my 3rd Mirena IUD and haven?t had a period or spotting in over 11 years, but started spotting about 24 hours after my first vaccine. The spotting lasted three days.

15 minutes after the injection I had an intense allergic/anaphylactic reaction. I was watched and treated on site by EMS for 2 hours with Benadryl, oxygen and rest. We did not use epi because I was still able to breath (minus some wheezing, coughing, hoarseness and lung irritation). I felt the reaction hit when I started seeing green spots and my vitals dramatically increased (BP 181/111, HR 142 and weak). I then experienced the following symptoms: rash/hives on neck and chest, fatigue and weakness, dizzy and lightheaded and needed wheelchair for moving around, chills and shaking, blurry vision, nausea, stomach pain, headache, chest pain and increased urination. I also had elevated glucose (147). During those two hours my vitals decreased a little, but the rest of my symptoms persisted. I was not getting better and my vitals started to increase again at the two hour mark so EMS called an ambulance and transported me to hospital. I was treated with solumedrol and observed for several hours. The meds helped enough to send me home. (I did have to continue taking Benadryl at home that night and the next day because I continued to have an allergic response). I also had severe injection site pain and bruising.

immune system was low; shingles; heart attack; This is a spontaneous report from a contactable consumer (patient) via Medical Information, also received via Pfizer-sponsored program. A 45-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Mar2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Within 5 hours after receiving the dose, she developed shingles on 23Mar2021. She stated the pain was so bad she thought she was having a heart attack on an unspecified date in 2021. Her medical doctor (MD) told her that she should get the second dose of the vaccine and that the shingles was dormant in her system and because her "immune system was low" she developed the shingles outbreak. The patient further stated that she developed shingles 4 hours later after receiving the first dose. She stated that the eruptions have stopped but it was still painful. She was asking if she should get the second covax or wait. The patient had not yet recovered from shingles while outcome of the rest of the events was unknown. Follow-up attempts are needed. Further information on the lot/batch number has been requested.

I was having my menstrual cycle when I got my second vaccine. Approximately 24 hours after receiving my second COVID vaccine, my bleeding became very heavy and I passed a large amount of clots. This lasted approximately 8 hours then stopped. Previous periods have been light, as I had a tubal ligation and ablation several years ago. After this incident, I did not have a period for 2 months. My cycle has since resumed.

Severe menstrual bleeding with clotting causing severe anemia. Hemoglobin level 9. Received first dose of Iron transfusion through IV yesterday on 4/23/2012

As described by the patient: As they were putting the vaccine, the area got really warm, and the arm began to feel inflated. Then I began to feel the liquid moving through my arm, elbow, and wrist. My wrist started hurting. I told the nurse, who told me to keep moving the arm. As time passed (15 minutes), the warm feeling flowed to my should and left side of my back. Another 15 min passed, and it moved down my left leg and knee, which started to hurt. Then got neck got warm and stiff, and I felt the warm feeling got to the left side of my brain. 15 minutes passed left side of the face got warm. And then it headed to my lips and then tongue. Lips got numb, and tongue got numb. 5 minutes pass and my tongue and

Immediate chest pain (tightening) , then arm pain while in store/pharmacy Next Day began spotting (menstrual bleeding) and lasted for 2.5 days Chest pain continued and has not stopped for last 10 days, intermittent throughout the day - tigheting of left side and right side of chest, radiates to theback Sunday following Monday vaccination (6 days later) got a blood clot on palm of hand, lasted for 4 days that started bleeding out and blood spread to front of hand like a birthmark as it bleed out

All Covid symptoms returned. Tremors. Severe headache. Numbness in right side of face and body. Dizzy. New was throat swell and tongue swelling.

This is a spontaneous report from a contactable consumer reporting for self. A 45-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm, on 19Mar2021 13:15 (Batch/Lot Number: EP7534) as a single dose (at the age for 45-years-old) for COVID-19 immunisation. Medical history included asthma and allergies. The patient did not receive other vaccines in the 4 weeks prior. She received an unspecified concomitant medication for allergy in the two weeks prior. The patient had not experienced COVID prior to vaccination. On22Mar2021, chills and headache started. On 23Mar2021, chills and headache continued and the patient experienced 102 fever with a little cough. She went to the Urgent Care and they diagnosed it as a side effect of the vaccine. On 01Apr2021, the coughing got worse and it turned into pneumonia. On 10Apr2021, she was admitted to the ER for over 103F fever, chills, cough, and shortness of breath. "Low immune from pneumonia developed or flared up the Valley Fever." The events were treated with steroid shot, antibiotic IVs, fluid IV, and more. The patient was COVID-tested post vaccination with Rapid COVID test (nasal swab) on 25Mar2021 with Negative result, and with PCR test (nasal swab) on 10Apr2021 with negative result. The outcome of the events was not recovered.

Pt presented to Urgent Care on the third day after vaccine (5/9) with chest pain, left arm pain, nausea and vomiting. EKG showed T-wave inversion on V2 and pt was sent to the ED for further evaluation. At the ED, bloodwork showed a significantly elevated troponin level. Pt was admitted for a possible NSTEMI and placed on a heparin gtt, diagnosis changed to myocardial injury within the setting of myo/pericarditis.

I developed an ITP flare after receiving vaccine and my blood platelets dropped to as low as 7000.; I developed an ITP flare after receiving vaccine and my blood platelets dropped to as low as 7000.; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer, Batch/Lot number was not reported), via an unspecified route of administration on 15Jan2021 as single dose for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took aspirin (e.c.) and developed allergies (known allergies Aspirin and related products), first dose of bnt162b2 in left arm on 29Dec2020 for covid-19 immunization. The patient developed an ITP (immune thrombocytopenia) flare after receiving vaccine and her blood platelets dropped to as low as 7000 on 22Feb2021. The patient underwent lab tests and procedures which included platelet count: platelets dropped to as low as 7000 on 22Feb2021, nasal swab: negative on an unspecified date. Therapeutic measures (Steroids) were taken as a result of events. No other vaccine in four weeks. No other medications in two weeks. The event resulted in doctor or other healthcare professional office/clinic visit. No covid prior vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The outcome of events was resolving. Information on the lot/batch number has been requested.

I had a subarachnoid hemorrhage on 4/30/21. It was suspected to be caused by a ruptured aneurysm. I was previously healthy and have no personal nor family history of this. It is unknown whether or not it is associated with the vaccine.

I haven't had my period for about 2 and a half years. I started bleeding vaginal on the 24th of May, about 12 days after the first dose of the covid 19 vaccine. On May, 25th I started having menstrual cramps, I felt nauseous, tired and general malaise. the bleeding is very heavy. today is the fifth day and I'm still bleeding.

Fever, Severe Chest congestion w/ wheezing, severe headache, shortness of breath. Diagnosed with pneumonia 3-4 days after vaccination. lasted approx. 2 weeks with symptoms. required 2 trips to urgent care, as of today, I still have minor chest congestion. Haven't been able to fully get rid of it.

I started a very heavy period that lasted 25 days. I usually have a light 2 day period like clockwork. No birth control.. very normal my whole life until my shot. I had heavy bleeding along with clots of blood.

PT STARTED EXPERIENCING INTENSE HEADACHES ON THE MORNING OF 5/21/2021. THE HEADACHES CONTINUED ON AND OFF FOR SEVERAL DAYS UNTIL ON 5/24/2021 AT 3 PM, SHE HAD A DEBILITATING HEADACHE WITH DIZZINESS THAT COULD NOT BE RELIEVED. THEN ON THE AFTERNOON OF 5/25/2021, SHE STARTED EXPERIENCING VISUAL CHANGES WITH BLACK SPOTS IN HER VISION. SHE WAS ABLE TO SEE HER DOCTOR ON 5/27/2021 AT 10 AM. HE SENT HER FOR A CT SCAN OF HER HEAD WHICH WAS FOLLOWED BY A MRI OF HER BRAIN. THE MRI AND CT SCAN REVEALED THAT SHE HAD A LEFT FRONTAL ISCHEMIC STROKE. SHE WAS ADMITTED TO THE HOSPITAL ON 5/27 AND DISCHARGED HOME ON THE AFTERNOON OF 5/28. SHE HAD A CT ANGIOGRAM OF THE BRAIN, AN ECHO OF THE HEART, ULTRASOUND OF THE CAROTIDS AND A HYPERCOAGULATION BLOOD PANEL. ALL OF WHICH WERE NORMAL AND SHOWED NO EVIDENCE OF WHERE THE BLOOD CLOTS CAME FROM THAT CAUSED HER STROKE. SHE CONTINUES TO HAVE HEADACHES WITH DIZZINESS, FATIGUE, AND NOW BAD ANXIETY.

During our event today, here at the Church in coordination with the Cleaning Services monthly training event, a patient had an anaphylactic reaction to the COVID vaccine. Anaphylaxis: 45yoF w/ h/o Rheumatoid arthritis and Wegener?s granulomatosis who takes immunosuppressive infusion 2x/yr, most recently in April, no h/o anxiety, and h/o COVID x2 (4/2020 & 10/2020), experienced an anaphylactic reaction, with symptom onset beginning within 1 min of us administering a 1st dose of the Pfizer-BioNTech COVID vaccine. Sx: throat clearing, cough, chest tightness, diaphoresis PEx: Alert throughout Hand over chest/ lower throat Shortness of breath Voice hoarse, speaking in 1-2 word sentence fragments Timeline: 10:35 - administered 10:36 - throat clearing 10:37 - advising pt to sign up for V-safe given her underlying autoimmune dz 10:38 - intermittent coughs 10:41 - drawing up epi 10:45 - Epi 0.5ml (1mg/ml) administered IM 10:46 - Called 911 for EMS 10:50 - Epi 0.5ml (1mg/ml) administered IM 10:55 - Diphenhydramine 50mg IM 10:57 - Pt notes throat feels more released from prior tightness 11:01 - EMS arrived, began evaluating patient 11:25 - Patient walked out to car, sister drove her home. Advised sister for her or their dad (at home) to stay with/watch the patient for at least the next 3 hours, to be sure angioedema does not worsen; I?m happy to giver pt her 2nd dose on the return date, but recommend if she gets it, best to get while in a hospital setting; to discuss whether or not to get 2nd dose with her Rheumatologist, especially given her prior COVID illnesses x2, making this her immune system?s 3rd exposure; consider getting Epi pen to carry with her for future. Following up with pt to advise her against getting an mRNA vaccine in the future, that currently the only other option in the U.S. is the Janssen/J&J vaccine, and that given her autoimmune disease, I would be concerned about her developing immune thrombosis and thrombocytopenia, so recommend she discuss with her rheumatologist, and that if she gets a subsequent dose of any COVID vaccine, to have it administered at a hospital location.

Ongoing migraine headaches that are not relieved. Loss of peripheral vision in left eye. Constant ear ringing. Blood clot in right arm. Ongoing dizziness and vertigo. Possible intracranial hypertension. I am being tested next week. These symptoms have been ongoing and have not been relieved. I was given Eliquis for the blood clot, which I no longer take. I take Trokendi 100 mg daily which is being increased for the migraine. I am also suffering with chronic fatigue.

Had 5 (periods instead of 3) in 3 months, one lasting 13 days. All were heavier and more blood clots then normal. My cycle was 28 days and now seems to be 21 days.

Pt rec'd 2 doses Pfizer/BioNTech, 2nd dose May 9,2021 at outside facility. Presented to hospital on 06/08/21 after cardiac arrest, sudden collapse at home, refractory PEA with ongoing CPR >4hrs, cardiogenic shock (EF20%), refractory DIC, MOSF and coma. Uncertain antecedent history, pt had tolerated vaccine well w/o untoward reactions, was possibly "sick" in the 2 days prior to admission 06/08, but limited history available. SARS2 PCR and resp path PCR panels negative, no clear bacterial source of shock/collapse initially identified, thus concern for primary myocarditis resulting in refractory shock (perhaps also with ischemic CVA); Tpn not c/w type I ACS/MI. Workup negative for PE, hemorrhagic stroke, PTX/tamponade, etc. 6hrs after death (in evening 06/08/21) BCx x2 resulted Grp A strep, thus pt may have had TSS at home then collapsed in PEA, however source of TSS is uncertain. Notably patient usually healthy, active, no medications, favorable lipid panel, no illicits; + EtOH binge-drinking last several months but no cirrhosis/ESLD previously doubt primarily Etoh-related process. Pt had ongoing PEA arrests with brief ROSC for approx 7 hrs in field -> ED > ICU until death declared.

Started getting pain in my right leg on May 1st, seen my Family Dr. on 4/29/21 clean bill of health. Pain wouldn?t go away was going to my chiropractor the whole month of May 2 times a week, for my right leg, I favored that leg never missing work, I?m a childcare provider. On 31May2021 the pain went down my leg and behind my knee just throbbing, I was walking up steps and a loud snap happens in my leg dropped me right there couldn?t move. Was taken to the ER, where they found a blood clot in my leg which caused pressure to build up on my knee which ruptured my meniscus, damaged joints, and cartilage in my knee. They put me on blood thinners, have to have surgery and can?t for 3 months I have to be off blood thinners. Can?t work and was forced to close my daycare business of 18 yrs and sell everything due to this injury. My Dr has linked it to the vaccine my blood wok showed high levels of hormones. Never ever had an issue until I got second shot. So now I?m trying to get disability, not looking good due to me being self employed. So who is gonna step up and help me financially, I was open threw the whole pandemic and this is how I go out of Business! Devastating to say the least?. My Community is shook up over this, so I took one for the team my family refuses to get the vaccine and others have decided NO after hearing my story.

Case developed symptoms 06/08/2021. Hospitalized and tested positive for Covid-19 on 06/13/2021 at Hospital. Has had symptoms including respiratory issues, a-fib, fever, chills, cough, shortness of breath, loss of smell, wheezing, headache. As of 6/16/2021 (date of entry) case requires oxygen. Remains hospitalized.

Headache, swelling, neck pain, high temp fever, pneumonia, loss of state and smell, swelling of lymph nodes.

First Pfizer Dose was administered to patient via right arm injection at 3:00pm on June 24,2021. Around 7pm same day patient began experiencing abnormal vaginal bleeding. The bleeding was about the same amount as the start of a menstrual cycle. Patient has not had a menstrual period since 2015 due to the surgical removal of all her reproductive organs including uterus , ovaries , fallopian tubes. Cervix was surgically stitched shut. Patient had to have her reproductive system removed due to a diagnosis of breast cancer back in 2013 to her left breast which required her to undergo chemo and hysterectomy of her breast and reproductive organs. Post vaccination patient abnormally experienced vaginal bleeding that cannot be explained being that she has no reproductive system. The bleeding lasted till next day.

The pain in my arm post vaccination on 5.6.21 never fully went away. It got better for a couple weeks but still noticed it. Around the beginning of June, the pain in my arm, at the vaccination site, started to intensify. I kept an eye on it for a couple weeks, thinking it'd get better but it didn't, it just got worse. On Tuesday, June 15th the pain really intensified. To the point that by Thursday, June 17th I was unable to move my arm. Because the pain was so bad I went to Urgent Care where they thought I was having muscle spasms. I knew something wasn't right so I contacted my doctor that afternoon who then sent me for blood work. He ran a D-dimer test which came back elevated on Friday June 18th. From there I went to the ER so they could run a doppler scan on my left arm. The pain was so bad they were only able to do half the test but quickly saw that I have a blood clot in one of the veins. The ER doctor put me on Eliquis and now here I am.

5/31/21 had back chest neck arm pain, went to medic, went into cardiac arrest, the did 18 minutes of CPR, got a heart rate, medivac?d me to Anchorage, AK spent 4 days in ICU, was told I had cardiac arrest due to pulmonary embolus,. Got a defibrillator installed in my chest.

ICA stroke; headache; earache; sinus issue; had sudden onset stroke symptoms while hiking; This is a spontaneous report from a contactable pharmacist. A 45-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular on 23Feb2021 (Batch/Lot number was not reported) at age of 45-year-old as DOSE 2, SINGLE for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Workplace clinic. The patient was not Pregnant at Time of Vaccination. Medical history included acne, eczema, HPV (had resolved in 2018); anxiety/depression, Known alleries Latex. 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 previously received First dose of bnt162b2 on 29Jan2021 at age of 45-year-old for covid-19 immunisation. Patient was with complaints of headache and earache. She was seen by urgent care twice (03Mar2021 and 10Mar2021) thinking it was a sinus issue. She then had sudden onset stroke symptoms while hiking and went to ED on 13Mar2021. she was transferred to a larger hospital and diagnosed with ICA stroke. She had no risk factors for stroke previously and her only prescription medication (norethindrone-EE) was discontinued 03Mar2021 thinking it was causing her headaches. Patient now is still having paralysis and is unable to independently manage ADLs. The adverse events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care.The onset date of ICA stroke was unknown, of other events was 03Mar2021. Stroke treatment Received. Duration of Hospitalization was 5 days. The events were assessed serious as Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, The outcome of events was Recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information about batch/Lot number has been requested.; Sender's Comments: Based on available information, particularly prolonged onset latency, it appears unlikely that vaccine BNT162B2 contributed to the reported events. These are probably intercurrent medical conditions. This case will be reassessed upon receipt of the follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

About three weeks after I received my second Pfizer vaccine, I noticed pain in my upper left arm, right at the vaccination site. Over the course of two weeks the pain intensified and got to the point that I was not able to use my left arm at all. The pain was debilitating. I contacted my primary care physician on June 17th 2021 who sent me for a D-diamer test. On Friday, June 18th, the D-diamer test was elevated so I went to the ER where they were able to do a doppler scan of my left arm. This confirmed the DVT (blood clot) in my upper left arm.

I had a stroke sometime between 11pm on April 22, 2021 and 8am on April 23, 2021. I'd had the vaccine at 4pm on April 21, 2021. I felt ill during the day on 4/22/2021 but took a nap and woke up feeling better before heading to bed at about 10pm.

Right after 2nd shot for 4 hours after I had tachycardia up and down. Then almost 2 weeks later I got an uti, that within 3 days turned into a severe kidney infection into sepsis. My liver enzymes were in the 500?s. My right kidney was swollen and I spent 4 days in the hospital and it took a month to return to normal. Then 3 weeks later I get diagnosed with pancreatitis on June 21. Symptoms subsided now they are back again. Fever, abdominal tenderness, flank pain, aches, and diarrhea and nausea. Took covid test always comes back negative.

5/31 patient developed chest pain while at work, presented to clinic at work. Had ECG changes, and MI was suspected, received SL NTG. 35 minutes after nitro she collapsed pulseless and apneic, cyanotic with agonal breathing and posturing. CPR initiated, external defibrillator was used with CPR device- received 4 shocks which failed. Spontaneously converted to sinus rhythm with restoration of pulse, awoke intact neurologically. Transferred to Hospital, underwent emergent LHC, did not show infarction and had normal epicardial anatomy. TTE was normal. CTA confirmed LLL small Pulmonary Embolism. Was started on Xarelto. She had an NSTEMI type II subendocardial injury secondary to V. fib arrest in context of PE or arrhythmia. Lab tests done during admission significant for mild transaminitis with AST 132, ALT with 36 ALP 51, triglycerides 608 unable to calculate LDL, beta-2 glyco 1 IgG normal at less than 9, lupus anticoagulant not detected, double-stranded DNA antibody 2 which is normal, ANA not detected, cardiolipin antibody IgG less than 10 which is normal, cardiolipin antibody IgM less than 10 which is normal, complete blood count unremarkable. Cardiac MRI with scar likely secondary to myocarditis. Started by cardiology on colchicine. Unknown etiology for pulmonary embolism, perhaps result of arrest/cpr. Had ICD placed.

Patient had left lower extremity pain x 4 days with left lower extremity swelling x 2 days. Patient diagnosed with an extensive deep vein thrombosis in left lower extremity.

Unexpected menorrhagia (heavy menstrual bleeding) with large (larger than half dollars) clots within 12 hours of receiving both the 1st and the 2nd Pfizer covid vaccine shots. (My periods are typically mostly normal and even though I have had heavy bleeding in the past on a few occasions, I've never experienced anything like this before.) After the 2nd shot, in addition to the menorrhagia, I also woke up the next morning with a large (about the size of a dime) subconjunctival hemorrhage in my right eye, at the top center portion of the sclera. It is mostly hidden underneath my eyelid, but is visible when I pull my eyelid back or when I look down or to the sides. (I have never had one of these before and it scared me, so I made an appointment to have it checked out.) Also, after the second shot, I have been experiencing bleeding gums when I brush or floss my teeth, which is also something new and unexpected and not something I typically or have ever experienced. It has now been 6 days since the second shot and I am still bleeding (heavy period bleeding with large clots), my right eye still has the large bloody spot (about the size of a dime), but thankfully my gums have stopped bleeding.

I couldn't breathe or swallow. This started about 2 months after vaccination. I went to the ED and they admitted me for 2 days. I went to hospital. They finally came up with laryngeal spasmatic pneumonia.

Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)

Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her own albuterol inhaler without relief. Transported to ED. PE: red hands with swelling, throat and lip swelling with difficulty swallowing. Later developed headache and dizziness then tachypnea and stridor. Meds given - See section 5 PLUS epinephrine IM and infusion @ 0.05 mcg/kg/min, Alb and ipratropium negs, racemic epi nebs. Admitted to the hospital on 12/22 and still hospitalized at the time of this report on 12/23. She remains on an epinephrine drip and was given methylprednisolone 125 mg IV x 2. No previous history of anaphylaxis. History of Reye's syndrome as a child when given aspirin.

Anaphylaxis throat felt like it was closing 15 minutes after getting vaccine Narrative: Employee self administered epi shot (has history of anaphylactic reaction to several nsaids, tessalon pearls). Bendadryl IM was given at observation area. She was sent to the ER where she was given Solumedrol and Pepcid. She's been seeing an allergist for past 3 months; reports she's had 2 previous shots of epinephrine from "something that was sprayed at work"

Patient had received second Pfizer vaccination after no reported issues with the first dose. Patient was observed post vaccination without incident and released. Patient developed wheezing and attempted to treat with her albuterol inhaler but did not improve. patient presented to the ED approximately 2 hours after vaccination and was admitted for respiratory failure and placed on BiPAP for a brief period of time. patient has known history of Asthma Exacerbation requiring hospitalization and intubations. D/C diagnosis Asthma Exacerbation

Deep vein thrombosis right gastrocnemius vein and superficial venous thrombosis in right small saphenous vein diagnosed January 15, 2021. Symptoms began with acute onset right lower extremity calf pain and swelling on January 14, 2021. Treatment with Xarelto began January 15, 2021.

4 days post 2nd vaccine I started vaginal bleeding. Lasted 2 weeks. Bleeding stopped for a few days then I started my regular period on my regular schedule

24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 days after vaccine), woke up with vertigo, visual changes, severe nausea, diagnosed with cerebrovascular accident

Patient was admitted s/p hysterectomy, found to have PE and AKI. Patient treated with heparin drip, transitioned to Eliquis and discharged

Patient received the 2nd dose of the Covid-19 vaccine at 16:26 today (2/25/21). She reported symptoms of difficulty breathing, tight throat and tight and numb lips at 16:34 today and alerted staff. At 16:35 epinephrine was given for suspected anaphylactic reaction. Vitals at 16:35 before administration of epinephrine were pulse ox 100% and pulse 67. Vitals at 16:37 were pulse ox 100%, pulse 170, and BP 162/102. First response called at 16:35. Patient felt immediate improvement in symptoms with epinephrine administration. First response team took patient to ED for further evaluation at roughly 16:40 by wheelchair.

sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints hurt; very large lymph node swelling on left (neck/collarbone/under arm).; cough; Spoke to MD regarding feet as it was difficult to walk; vaginal bleeding; headache; fever 101.9; felt like I was in shock; uncontrollable shaking; fast breathing; freezing; nauseous; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 10Feb2021 at 11:00 AM (at the age of 46-year-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to sulfa drugs. The patient has pins in both feet from prior surgery. Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ) on 19Jan2021 at 11:30 AM (at the age of 46-year-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. The patient stated that it was unknown if prior to the vaccination, she had COVID-19. The vaccine was administered in a Nursing Home facility. Concomitant medications were not reported. The patient did not receive other vaccines within four weeks prior to the COVID vaccination. On 11Feb2021 the patient awoke at 1:30 AM with uncontrollable shaking, fast breathing, and she was freezing. She had no temperature at that time, almost felt like she was in shock. She took a shower and got calmed down. She was very nauseous but able to go back to sleep. At 04:30 AM she awoke again, this time with headache and a fever of 101.9. She continued with a fever in the 101.1 to 101.9 range for remainder of the day. The next day, 12Feb2021, she awoke feeling better and no fever but she had welts on her toes and her feet were swollen. Both feet and hand joints hurt and she had very large lymph node swelling on left (neck/collarbone/under arm). She also had developed a cough. She spoke to her MD regarding her feet as it was difficult to walk. They directed her to the Emergency Room (ER). The ER staff said to watch for two days. Later that evening (12Feb2021) she started having some shortness of breath and vaginal bleeding. She has an IUD and has not had a period for four years. She called the ER and they gave same advice. She had no fever that day (13Feb2021) but she woke around 3:30 AM soaked. As of 14Feb2021 she was still short of breath on/off and still has sore feet. The patient did not receive treatment for the events. Lab data included Fever of 101.9 on 11Feb2021 and fever in the 101.1 to 101.9 range also on 11Feb2021. The clinical outcome of shortness of breath was reported as not recovered. The clinical outcome of shock-like symptom, shaking, fast breathing, feeling cold, nauseous, headache, fever, welts, swelling of feet, arthralgia, lymphadenopathy, cough, gait disturbance, vaginal bleeding, hyperhidrosis was reported as recovering. The patient has not been tested for COIVD-19 after the vaccination. Information about lot/batch number has been requested.

got vaccine - about a week later - she sent us a message saying "I have been having right calf pain for about a week or more. I have more increased SOB and chest pain." was able to get ddimer which was elevated - and was admitted to the hospital for this since her vaccine - she has noticed increased chest tightness, SOB, hairloss, DVT/PE.

patient administered vaccine at another facility and presented to this facilities ED on 2/24. Patient with multiple comorbidities: Bipolar disorder, parkinsons, PD, COPD, DM, PVD, GERD, HTN, Dyslipidemia, sleep apnea. H/O CVA, has sacral decubitus and cellulitis of pannus. presents with sepsis likely secondary to cellulitis of pannus. Admitted for care then discharged on 2/26

severe thrombocytopenia; Bleeding at Impella insertion site; peripheral swelling in hands/feet; cardiogenic shock; myocarditis; hypoxic respiratory failure; mural thrombus; hypotensive despite pressors; fever; cough; myalgias; This is a spontaneous report from a contactable physician. A 46-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not provided), intramuscularly on 05Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history included hyperlipidemia and COVID-19 pneumonia from an unspecified date in Jan2021 to an unspecified date in Jan2021 (the patient was diagnosed with COVID-19 pneumonia prior to the vaccination. Recovered. Returned to work on 25Jan2021). Concomitant medications included atorvastatin orally at 10 mg, once a day, acetylsalicylic acid (ASPIRIN) orally at 81 mg, once a day, colecalciferol (VITAMIN D); all the drugs were received within two weeks. The patient previously took clindamycin and experienced known allergies: Clindamycin. The patient did not receive other vaccine in four weeks. The patient developed fever, cough, myalgias on 19Feb2021 at 12:00 AM. She developed peripheral swelling in hands/feet on 24Feb2021, she was evaluated in the ER; admitted to (hospital name withheld) on 24Feb2021 with cardiogenic shock, myocarditis, hypoxic respiratory failure. The patient was started on IV vancomycin and Unasyn. TTE (transthoracic echocardiogram) demonstrated LVEF (left ventricular ejection fraction) 35%; reduced biventricular function; mural thrombus on 24Feb2021. Remained hypotensive despite pressors on 24Feb2021. Patient had elevated PCW with preserved cardiac index. Patient underwent VA ECMO (veno-arterial extracorporeal membrane oxygenation) and Impella placement on 25Feb2021. COVID-19 PCR was negative. Blood cultures were no growth. She developed severe thrombocytopenia and developed bleeding at Impella insertion site on 25Feb2021; required multiple, PRBC transfusions. Evaluated for HLH; Soluble IL2 receptor on 26Feb2021 elevated at 7232 pg/mL; ferritin 3054; CRP > 300. ECMO stopped 03Mar2021. The patient was treated with IV antibiotics, mechanical ventilation, pressor support, underwent VA ECMO and Impella placement. The patient was hospitalized from 24Feb2021 to 16Mar2021. Number of days of hospitalization was 20 days. The patient tested COVID post vaccination. The patient underwent lab tests and procedures which included blood pressure: hypotensive despite pressors, LVEF: 35 %, nasal swab: Negative on 24Feb2021, blood cultures: No growth, nasal swab: Negative on 25Feb2021, ferritin: 3054, HLH: Evaluated, Soluble IL2 receptor: 7232 pg/mL (elevated at 7232 pg/mL), CRP: > 300 on 26Feb2021, nasal swab: Negative on 11Mar2021, nasal swab: Negative on 14Mar2021. The events were considered as serious (hospitalization and life threatening) by the physician. The outcome of the events was recovering. Information about lot/batch number has been requested.; Sender's Comments: the events being serious, life threatening and hospitalisation ,medical intervention required are assessed as possibly related to the suspect drug __BNT162B2____ based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications.

Shortness of breath, Diffuse Pulmonary Embolism with Ground glass opacities, happened over course of 1 week

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Hyperventilation-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient presented with soarness in throat a couple of hours after administration. SHe was taken to the fire department (Uncertain about what treatment was conducted here). Next day, and patient is still not fully recovered. Still has scracthy throat and soreness in her throat.

Evening of: Pain at injection sight (expected), pain down the left lung/torso area. Day 1 Post: Pain on left lung/torso, nausea, vomiting, fever 99.2, tiredness Day 2 Post: Pain on left lung/torso, nausea, vomiting, fever 99.6, tiredness Day 3 Post: Significant pain increase and ranging from left collar bone down left lung/torso, nausea, increased difficulty breathing. ***Went to ER and was diagnosed with bilateral pulmonary emboli*** Day 6 Post: Coughing up blood *** returned to ER***

01/17/2021 Pain in Right opposite of the arm got vaccination in 01/18/2021 felt a lump and had spotting bleeding . Unusual hormonal changes after the shot. Dr. seemed unconcerned. Sen to the Breast Specialist and she is schedule for a diagnostic mamma gram.

Delayed anaphylaxis. Treated with diphenhydramine and albuterol at 90 minutes post vaccination, epinephrine at 125 minutes post vaccination. Patient release from ER after 4.5 hours, discharged home.

Was taken by ambulance diagnoses anaphylaxis Throat swelling itching you get swelling was released after 4 hours with meds given iv steroids iv Benadryl

skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphylactic reaction; my throat was closing; my tongue swelled up to the back of my throat; she experienced Body aches; At home she started wheezing; Dry cough; Hoarse voice; Upper airway swelling; Difficulty breathing (without wheeze or stridor); bronchospasm; Respiratory distress; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: ER8732), dose 1 via an unspecified route of administration, administered in Arm Left on 26Mar2021 at 10:30 as single dose for COVID-19 immunisation. Medical history included celiac disease and asthma. The patient had allergies to medications, food, or other products. Concomitant medication(s) (received within 2 weeks of vaccination) included levocetirizine dihydrochloride (XYZAL), Dexalant and birth control pill. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26 Mar2021, the patient experienced anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high, my throat was closing, she experienced body aches and at home she started wheezing/bilateral wheeze. Within minutes of receiving the vaccine, my tongue swelled up to the back of my throat and she had a weird sensation in her throat, 15 minutes later she was not able to form words. The patient was given liquid Benadryl (oral) for my tongue swelled up to the back of my throat and her symptoms resolved. She went to the nurse station, who took her BP which was high, which it normally is not so the treating physician felt confident in letting me go home. She was monitored for an hour and was sent home with no more tongue swelling. At home she started wheezing. She called her HCP and was advised to take a nebulizer with no effect. At around 14:00, when the Benadryl wore off, her throat was closing so she was directed to epi-pen herself and call 911. She was taken by ambulance to the hospital and treated for anaphylactic reaction to the vaccine. She was given prednisone 50mg by mouth daily for four days and a refill for her Epipen. No additional Epipen was administered. On 29Mar2021, the patient experienced skin hurting like a neuropathy, chills and she experienced a rash. On an unknown date in Mar2021, she experienced bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor). No sneezing or rhinorrhea. She was treated with adrenaline, corticosteroids, antihistamine, IV fluids, Oxygen, bronchodilators and other. The adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The administering doctor not to take the second vaccine. The outcome of the events anaphylactic reaction, my tongue swelled up to the back of my throat, my blood pressure was high and my throat was closing was recovered with sequealae, skin hurting like a neuropathy, she experienced body aches, at home she started wheezing/bilateral wheeze, chills and she experienced a rash was recovered and bronchospasm, upper airway swelling, respiratory distress, dry cough, hoarse voice and difficulty breathing (without wheeze or stridor) was unknown. Follow up attempts are needed. Information on lot /batch number was obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Massive PE, patient died. No history of DVT, we did a COVID test here and it was negative. She had no PMH, we suspect the vaccine made her hypercoagulable. Had pleuritic CP, tachycardia, tachypnea.

DVT right leg began on evening of Feb 28 but became evident March 1 morning and diagnosed evening at ER

Went to ER and was diagnosed with bilateral pulmonary emboli; Pain on left lung/torso/Severe pain on Left lung/torso, pain starting at collar bone down the torso; increased difficulty breathing; Vomiting; fever 99.2/fever 99.6; Tired; Nausea; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER 8727), via an unspecified route of administration, at the age of 46 years, administered on the left arm on 23Mar2021 10:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to PCN from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, norgestimate (TRI-SPRINTEC) and fluoxetine (FLUOXETINE); both taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicilin and experienced drug hypersensitivity. The patient went to ER and was diagnosed with bilateral pulmonary emboli on 23Mar2021 21:30, pain on left lung/torso/severe pain on left lung/torso, pain starting at collar bone down the torso on 23Mar2021 21:30, increased difficulty breathing on 23Mar2021 21:30, nausea, vomiting, fever 99.2/ 99.6, tired on 23Mar2021 21:30. The patient underwent lab tests and procedures which included body temperature: 99.2 on Mar2021, body temperature: 99.6 on Mar2021, sars-cov-2 test: negative on 01Apr2021. Therapeutic measures (Eliquis (blood thinners)) were taken as a result of the events. The events were reported as Life threatening. The outcome of the events was recovering.

Patient states that 3 days after she received the Pfizer vaccine she started a mentrual cycle. When she came back to the pharmacy three weeks later she stated she was still having her menstrual cycle, and the bleeding was very irregular, sometimes clotty. She said she had just finished her menstrual cycle before receiving the first dose so shouldn't have had a cycle, and that also she was always very regular with her cycles prior to this.

Patient presented to Hospital with an anterior wall myocardial infarction 5 days after second Pfizer COVID19 vaccine. She was fully anticoagulated with Warfarin at the time of presentation. No prior cardiac history. She was treated with primary PCI of the LAD.

On 3/17/2021, I began to have a very heavy mentrual period and it was 5 days early (which never happens). On 3/22/21 I had a nose bleed at work, which also never happens. I got home from work at an RN and took off my compression stocking and had bad petechiae all over my lower extremities and scattered throughout my body. I immediately went to the Emergency Room. My labs at the ER showed my platelets were 2000! Normal platelets are over 150,000. They admitted my for thrombocytopenia and I was hospitalized for 12 nights. I was given platelets, high doses of prednisone, IVIG infusions 8 times, rituximab infusion 4 times, bone marrow biopsy which was negative, and nplate injections. Since discharge, I have been seeing the hematology team 3 times a week at facility, labs 3 times a week, rituximab infusion every friday, nplate injection once a week. I have not been able to work since 3/22/21. My diagnosis is an autoimmune response called idiopathic thrombocytopenia.

I have been without a menstrual cycle for a minimum of 2 years because of the Depo Provera injections. However, I had vaginal spotting/light bleeding that started approximately 9 hours after I received the vaccine and lasted for about 48 hours.

Patient has rash that started on torso and radiated to entire body lasted about 10 days. Patient developed fever greater than 100.4 for 2 weeks. Patient started to develop tachycardia approx 4 days after rash appeared. 1/11/21 patient saw Dr. had a negative COVID test. Started on Prednisone taper x 10 days. Also taking diphenhydramine po bid. Back to physician 1/21 due to rash and tachycardia (HR in 160's). Rash resolved, fever subsided but patient referred to cardiologist . Patient ordered an echocardiogram and stress test. Patient had episode of afib and left bundle branch block during stress test. Cardiac Catheterization on 2/18/21, structurally cleared. So causation considered electrical. Patient currently taking atenolol.

Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the hospital and was diagnosed with a blood clot/DVT.; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:00 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later, the patient went to the hospital and was diagnosed with a blood clot/DVT. AE resulted in: [Emergency room/department or urgent care]. The patient received treatment for the events: Vitals taken, blood work, prescribed blood thinner. The patient underwent lab tests and procedures which included blood test: unknown result on an unspecified date ae treatment= Vitals taken, blood work , investigation: blood clot/dvt on 08Apr2021 3 days later I went to the hospital and was diagnosed with a blood clot/DVT, investigation: unknown result on an unspecified date ae treatment= Vitals taken, blood work. The outcome of the event was recovering. The patient does not have COVID prior vaccination, and was not COVID tested post vaccination. The patient has no known allergies.

Anaphylactic reaction; a lot of "brain fog"; Diarrhea; Her hip pain has gotten progressively worse; This is a spontaneous report from a contactable consumer via Program. The 46-years-old female consumer (patient) received BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown,) on 19Mar2021 via an unspecified route of administration as a single dose for COVID-19 immunization. The medical history and concomitant medication were not reported. The other medication included XELJANZ XR TAB 11MG since 28Jul2020. Patient reported that she had an anaphylactic reaction to her first Pfizer COVID-19 vaccine on 19Mar2021. Since this reaction she has had a lot of brain fog and diarrhea, that was not happening before the reaction. Patient also said that her hip pain has gotten progressively worse and affecting her ability to dress herself. Further patient explained she will miss 2 doses of Xeljanz before she receives the medication on 15Apr2021. The outcome of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Two large hot swollen areas on right leg Went to ER ultrasound detected superficial clot; This is a spontaneous report from a contactable consumer (patient). This 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 19Apr2021 12:15 (Batch/Lot Number: EWO164) as a single dose for COVID-19 immunization. The patient's medical history was not reported. Patient is not pregnant at the time of vaccination. Concomitant medications included fluticasone propionate (FLONASE), fexofenadine hydrochloride (ALLEGRA), and ibuprofen. The patient previously took tobramycin and Wellbutrin and experienced allergies for both. Patient received the first dose of bnt162b2 for COVID-19 immunization on an unspecified date (lot number unknown). 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. Patient has not been tested for COVID-19 since the vaccination. On 20Apr2021 18:30, patient had two large hot swollen areas on right leg. She went to the ER. Ultrasound detected superficial clot. AE resulted in emergency room/department or urgent care. Patient has not recovered from the event. Treatment included antibiotics and ibuprofen.

Eye swollen closed, throat scratchy and swollen. Per ED MD, severe allergic reaction consistent with anaphylaxis. Also has allergy to ibuprofen and reports took some earlier today; mistook the brand name for acetaminophen.

Prolonged heavy menstrual cycle with excessive blood clot starting on 3/22/21 till present 5/10/21. Despite intervention by ob/gyn such as performing pelvis ultrasound and performing a uterine biopsy with negative result for cancer as well as treating me with medroxyprogesterone for a course of 15 days that I completed as prescribed . After the medroxyprogesterone, I have to be placed 3 days ago on birth control pill, the menstrual bleeding continues . It?s been almost for 50 days. Need help!

Reported feeling fatigue and contractions early on after the second vaccine dose. Then the next day had pain and welts at heparin injection sites as well as increased contractions. Two days after vaccine went in for weekly fetal ultrasound and a large subamniotic hematoma [up to 7 cm in the greatest diameter] was found that was not present on ultrasound the week prior. There was mild thrombocytopenia on testing. Because of the hematoma providers did not want to continue anticoagulation. However due to an elevated risk of thrombosis due to a compound thrombophilia and pregnancy prolonged pregnancy without anticoagulation would also have a high risk for adverse outcomes. The decision was made for preterm delivery at 35 weeks. The postpartum course was complicated by postpartum hypertension. The newborn required an intensive care unit admission due to hypoxia within the first day of life and was found to have neonatal pneumonia.

patient called and said 10 days post she had a heart attack and was hospitalized. no further information given

I started having shortness of breath and went to the emergency room. It was determined I had blood clots in both lungs and I was prescribed blood thinners for the next 3-6 months

anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations; her feet turned like a reddish color; fatigued; chills; felt out of sorts for a couple of days; her throat was a little sore; not feeling well; chest was just hurting; slight nausea; caller kept moving her arm in a circular motion to keep it from getting stiff; numbing tingling in my foot; numbing tingling in my foot; lost my voice; i was in bed for 1 week and 3 days; scary; a warm sensation in her stomach; felt out of sorts; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EW0170, first dose) solution for injection intramuscular in the left arm on 29Apr2021 at 17:15 (at the age of 46-years-old) as a single dose for COVID-19 vaccination. Medical history included fibroids (had to have 3 blood transfusions for this), severe allergy to fish and tomato, and chronic anemia (diagnosed with this after she had her children). Concomitant medication included diphenhydramine hydrochloride (BENADRYL) for very bad allergies. Family history included chronic anemia and Hashimoto's disease disorder (grandmother) in 2020. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 29Apr2021, the patient experienced anaphylactic reaction, heart palpitations, stomach burning, warm sensations, her feet turned like a reddish color, fatigued, chills, felt out of sorts for a couple of days, her throat was a little sore, not feeling well, chest was just hurting, slight nausea, kept moving her arm in a circular motion to keep it from getting stiff, numbing tingling in my foot, lost my voice, felt like I was dying, was in bed for 1 week and 3 days, scary, a warm sensation in her stomach, and felt out of sorts. The events did not require a visit to Emergency room or Physician's office. Unspecified treatment was provided for the event nausea. The outcome of the events heart palpitations, stomach burning, feet turned like a reddish color, throat was a little sore was recovered in 2021. The outcome of the events fatigued, chills, nausea was recovering. The outcome of the event warm sensation in her stomach was recovered on 29Apr2021. The outcome of the other events was unknown. No follow-up attempts are needed. No further information expected.

I've had 3 separate issues of cold symptoms in the past month/she has had a cold; I had flu like symptoms with the headache, body aches; low grade fever; not feeling well; This time, it's like sinus issues; nose stuffy and runny; super tired; nose stuffy and runny; in my chest, I was wheezing; pneumonia; coughing/dry cough; I had flu like symptoms with the headache, body aches; I had flu like symptoms with the headache, body aches; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in Arm Left on 29Mar2021 (Batch/Lot Number: EP6955) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included , autoimmune disorder, blood cholesterol increased from 30Dec2020, crohn's disease from Oct2014, hysterectomy from 2016. The patient previously received BNT162B2 on 08 Mar2021 for COVID-19 immunization (Lot EN6205, Expiration is unknown. Injected intramuscularly on left arm. Concomitant medications included vedolizumab (ENTYVIO) taken for crohn's disease from Aug2020 to an unspecified stop date; atorvastatin (LIPITOR [ATORVASTATIN]) taken for blood cholesterol increased from 30Dec2020 to an unspecified stop date; testosterone (TESTOSTERONE) taken for an unspecified indication from 12Apr2021 to an unspecified stop date. Ever since she took it, she has had a cold. She has been to Urgent care 3 times, and has had COVID test and they were negative. Flu test was also negative. Her symptoms have been kind of different each time, but it seems like cold symptoms. She clarified to say that all occurred after second dose and she meant that each occurrence of side effects, her symptoms were a little different. She would like to know if this is related to the vaccine or is it just a cold. There was no prescriber. She had No effects after first vaccine. The following day after my second dose, I had flu like symptoms with the headache, body aches; that cleared up in 2 days on 07Apr2021. Within the first week after second dose, it was like the flu. She had body aches from head to toe, coughing on 19Apr2021, fever, and felt blah overall. That went away. Then the second week ,she thought she had pneumonia on 21Apr2021 and had wheezing in her chest on 21Apr2021, dry cough, low grade fever, over all body aches, same thing as first. Now this week it feels like sinus problems, such as headache on 07Apr2021, sinus, no body aches, On 02May2021, This time, it's like sinus issues, nose stuffy and runny, super tired. She thought it was allergies at first. Feeling blah overall improved after they gave her medication. They gave her a Z-Pak, wish she later said was Azithromycin. They gave her the same thing both times.Azithromycin tablets 250 mg. two tablets first day and one tablet rest of time for 4 days. It helped her get better. It is in a pharmacy vial with no lot or expiration. Second medication was Benzonatate 200 mg one capsule by mouth three times daily for cough. It is also in a pharmacy vial with no lot or expiration. She has been taking over the counter stuff. She has the same ones they gave her before and she did not take those this time because her symptoms were different. This time she took over the counter because she thought it was allergies. She took Benadryl, Nyquil, TheraFlu, Alka-Seltzer cold and cough drops. She bought all over the counter and did not feel they are working. Benadryl 24 capsules, Lot 1805148, Expiration Mar2022, Dose 25mg, Count size 24, Sealed and intact. She would not be willing to send a sample. Nyquil Lot 0315171912, Expiration Dec2022, 30 ml every 6 hour, count size in bottle is 12fl ounces. Sealed and intact. She would not be willing to send a sample.Thera-Flu Lot 6N8S Expiration Jun 2021, Dose is 1 packet every 4 hours, She did not take it like that though. Count size is 6. Sealed and intact. She would not be willing to send a sample. Alka Seltzer cold and flu, Lot NAA85RD, Expiration May2021, dose is 2 tablets every 4 hours and count size is 16. Sealed and intact. She would not be willing to send a sample. Ricola cough drops, Batch 2000049350, Expiration Jun2023. Sealed and intact. She would not be willing to send a sample. The patient underwent lab tests and procedures which included covid-19: negative on negative, influenza: negative on negative. Therapeutic measures were taken as a result of the events. The outcome of the event pneumonia, headache, general body pain, low grade fever, in my chest, I was wheezing was recovering, the outcome of the event coughing/dry cough, This time, it's like sinus issues, nose stuffy and runny, super tired, nose stuffy and runny was not recovered, while unknown for the other events.

I started having shortness of breath and went to the emergency room. It was determined I had blood clots in both lungs based on a CT Scan; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 14Apr2021 (Lot Number: EW0153) as 2ND DOSE,SINGLE for covid-19 immunisation. Medical history included Sleep apnoea. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medication(s) included phentermine hydrochloride (LOMAIRA); fluoxetine; loratadine (CLARITIN); diphenhydramine and Charlotte24 (unspecified). The patient previously took morphine and tetracycline and experienced drug allergy. Patient took the first dose of bnt162b2 (lot number EN6207) in right arm on 17Mar2021 for covid-19 immunisation. The patient started having shortness of breath and went to the emergency room on 10May2021. It was determined she had blood clots in both lungs based on a CT Scan. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient hospitalized for two days. Patient received blood thinners as treatment. The patient had covid test type post vaccination nasal swab on 14May2021 with negative result. The outcome was recovering.

5 days later, pt began to feel tired, 13 days later, she had a TIA with hospitalization for 24 hours, a hypertensive emergency, 202/122.

I started bleeding and blood clotting and hemorrhaging blood really bad. I have fibroids and anemia. That 2nd shot made my condition really horrible. I was managing my condition before that shot. I have to get a surgical procedure done. I wasn't asked if I had a blood disorder during both of my shots and I was not aware that I should have not gotten the shot when I have a blood disorder. I just found out about this today.

Vaginally bleeding x4 days; diarrhea x 2 mornings; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0179 and expiration date was not reported), via an unspecified route of administration in right arm, on 13May2021 at 10:30 (at the age of 46 years old) as 1st dose, single for COVID-19 immunization in a hospital. Medical history included colon polyps, bipolar II disorder, inattentive add and early cardio disease. Concomitant medications included sertraline hydrochloride (ZOLOFT); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); sulfamethoxazole (+) trimethoprim (BACTRIM) and ibuprofen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was never tested for COVID-19. The patient experienced vaginal bleeding for 4 days and diarrhea for 2 mornings on 15May2021 at 10:00. The events were assessed as non-serious by the reporter. No treatment was received by the patient regarding these events. The outcome of these events was recovering at the time of report.

Two weeks after receiving my vaccine, I had a mini stroke while driving. I was able to get to my destination safely thank goodness. A friend took me immediately to the Er where I was admitted for 4 days. I experienced another stroke somewhat similar as the first but less intense 2 days after the first one.

Post menopausal bleeding starting April 30th and continued through until May 9th and again from May 13th - May 17th. Ultrasound ordered and norethindrone 5mg tables (5 tablets) were prescribed and taken to stop bleeding.

Miscarriage. Had first vaccine dose about 2 weeks after a positive home pregnancy test (on 04/24/2021). Date of last period was 03/19/2021. No fertility treatments. Spontaneous pregnancy at 46 years old. Had 2 previous miscarriages - 6 months earlier and 3 years earlier. Started bleeding and cramping 05/26/2021. Went to emergency room. They checked with ultrasound and said it was probably a miscarriage. The baby should be 9 or 10 weeks, but the ultrasound showed it was much too small for that - probably stopped developing at about 6 weeks. Pregnancy hormone levels were normal, however. Followed up with OBGYN the next day - she confirmed it looked like a miscarriage. The cramping/bleeding lasted for another week. Follow-up appointment on 06/04/2021 showed the uterus had completely emptied.

I had superventricular tachycardia from age 12 to age 28. At 28 years old, I had an ablation to correct this condition. I did not have a single episode of afib from my ablation until I received my COVID-19 vaccine. Now, I have episodes regularly. I also have an extremely regular menstrual cycle. My cycle has been abnormal and erratic since my first shot, 2/19/21.

Anaphylactic Reaction, Epi-Pen, Albuterol given. Transported by Ambulance to ER, given Benadryl, Pepcid, Prednisone. Prescribed Benadryl, and Prednisone. Released from ER 5 hrs after onset of Allergic Reaction. Reaction began around 10:35 am, released from ER around 3:30pm - 3:50pm

post menopausal vaginal bleeding; She had spotting occur a week later on 30Apr2021; This is a spontaneous report from a contactable consumer (Patient). A 46-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0158/Batch number was not reported), via an unspecified route of administration, administered in arm left on 24Apr2021 (at the age of 46-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history of the patient included hormone therapy, menopause from an unspecified date in Aug2008 (It has been 13 years since patient went through menopause in Aug2008), covid-19 from an unspecified date in Feb2021 (She had COVID She had Covid, she thinks around February. She was not tested but had antibodies. She had COVID then and then she tested positive for antibodies before getting the vaccine), hypersensitivity from an unspecified date in Feb2021 (The only time she did not feel well was with allergy symptoms, around mid Feb2021, around 15Feb2021). Concomitant medications included estradiol at a dose of two times daily (0.5pr, 30mg, one click, twice a day) taken for hormone therapy and testosterone cream daily (2% cream, MWF, 2 clicks per day) taken for hormone therapy. Family medical history included her parents and sister all were vaccinated and were fine. Her dad and sister have heart conditions but have been fine, no one had any effects other than like sore arm and tired. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines on the same day of vaccine vaccination. The patient did not have any previous history of immunization with Pfizer vaccine. On 30Apr2021, the patient experienced post-menopausal vaginal bleeding. The bleeding was on and off a couple times, but it was not going on anymore. The reporter stated that, she had spotting occur a week later on 30Apr2021 and then she was full on bleeding from the 03May2021 to 09May2021. She said it was not like it has only been a couple years, she said she normally does not bleed. Patient contacted the doctor when she had spotting. She was having sex and did not really associate it with the vaccine because she had her shot in the arm and didn't have many symptoms from it. It has been a while since her last period. She used to have lighter periods she was not a heavy bleeder but with this she had super tampons in and pads and went through them in an hour, intermittently. It was a lot of blood. Patient spoke with her gynecologist who sent her to get an ultrasound because she said she should not be bleeding so she wanted to rule out cancer. The ultrasound was on 06May2021 and was normal. The doctor gave her 5mg norethindrone to take every night. It was given to stop the bleeding; it was 5 tablets one every night. She took it from the 06May2021 to the 10May2021 and her doctor said it should stop within a couple days, but it took longer, it stopped on 10May2021. Then it started again and bled from 13May2021 to 17May2021. After 17May2021, there was no more bleeding. Is pretty sure it was 17May2021, was roughly around that time. The patient underwent lab tests and procedures which included pregnancy test: not pregnant on an unspecified date, ultrasound scan: normal on 06May2021 and blood work: unknown results on 02Jun2021. The outcome of the events was resolved on 17Apr2021. Information on the lot/batch number has been requested.

4/19/21 patient states she began menstruating (which was a week past due from her normal expected start date of 4/12/21). On 4/26/21 patient contacted her physician with concerns because the bleeding had not stopped. Autoimmune flare-up started 4/27/21 and patient began medicine for her flare-up on 4/29/21. The following week, 5/3/21, patient wen to family doctor regarding the autoimmune flare-up and concerns about the continued bleeding. MD advised patient to contact OB/GYN about the continued bleeding and to continue on her Dapsone until flare-up had resolved. Also MD advised patient to cancel her second appt for the vaccine and to postpone until a week or two after the completion of Dapsone. 5/7/21 patient spoke to GYN office and nurse advised patient to watch the bleeding until another cycle was supposed to start and finish and to see if the bleeding would resolve on its own given another cycle was supposed to start and finish (expected cycle start date 5/19/21). Patient kept bleeding and called md back and notified that not only did the bleeding NOT stop, the flow had increased to an alarming rate and amount. 6/1/21 spoke to office again and nurse advised patient to pick up an rx for progesterone to assist in stopping the bleeding. Patient started the rx on 6/7/21. The patient had increased blood flow and started passing clots and went in for an exam. MD changed drug and increased dosing.

I was diagnosed with Atrial fibrillation after this shot. The first shot was 03-18-2021. A heart monitor for 30 days caught the AFib. Dr referred me to the electrophysiologist in their office for treatment of A-Fib. I have fluttering that feels like butterflies and it flutters in my back shoulder blade. A heart ablation (surgery) is recommended. The event monitored showed over 8, 500 abnormal heartbeats. A fib was caught during the 2nd week of wearing the monitor which was shortly after the 1st Pfizer shot.

My sister has developed multiple Blood Clots in both of her lungs. She is now currently hospitalized. No history or family history of Blood Clots. No damages.

dural venous sinus thrombosis involving the mid and posterior aspects of the superior asagittal sinus, extending into the transverse and sigmoid sinuses. The dural venous sinus thrombosis extends into the upper 1/3 of the jugular vein on the left and to the jugular bulb on the right. She also has subarachnoid hemorrhage in the left inferior temporal lobe and bilateral occipital lobes. The event that led to hospitalization and finding the thrombosis was a syncopal episode on 7/7/21

lots of clots; Heavy menstrual-like bleeding; recurring urinary tract infection symptoms; intense lower back pain.; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EP7534, age at vaccination 46-years-old) via an unspecified route of administration and administered in left arm on 18Mar2021 08:00 as first dose, single for COVID-19 immunization. The patient's medical history included thyroid cancer survivor and allergies to Ciprofloxacin. The patient concomitant medication included levothyroxine sodium (UNITHROID) prior 2 weeks 112mg. The patient had no covid prior to vaccination. The patient did not take no other vaccine in four weeks. The patient experienced heavy menstrual-like bleeding, lots of clots, recurring urinary tract infection symptoms and intense lower back pain on 28Apr2021. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for events. Covid was not tested post vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533), dose 2 via an unspecified route of administration and administered in left arm on 08May2021 10:00 am. The outcome of events was not resolved at the time of this report. Follow-up(30Jun2021): Follow-up attempts completed. No further information expected.

Systemic: Allergic: Anaphylaxis-Mild, Additional Details: PATIENT EXPIRIENCED BRUSHING AND ITCHINESS NEAR THE INJECTION SITE AND ON FACE . PATIENT ALSO EXPIRIENCED NAUSEA. PATIENT SAID SYMPTOMS ARE GETTING BETTER. REFER TO SEE DOCTOR OR COME BACK TO PHARMACY IF ANY OF ABOVE MENTION SYMPTOMS GET WORSE

Period lasted longer than 8 days, then restarted and was very heavy and super painful for 5 more days, lots of clotts.

Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Fever-Severe, Systemic: Weakness-Severe

After having the vaccination and waiting 15 minutes at my PCP's office I left. My husband was driving and took me to a local supermarket where I shopped for a short time and then returned home. My home, the PCP and the supermarket are all within close proximity. Upon return home, I was walking in front of my husband, wearing an ankle boot prescribed by my Podiatrist, and a skirt. My husband asked why my left leg calf was twice the size of my right. I entered our home, set in the recline, removed the ankle boot and noticed a huge amount of swelling from my left foot to just up above my left knee. It was indeed twice the size, perhaps a bit more, than my right side. Also, just below my left, on the side of my inside calf, there was an XL raised, red, clearly outlined/defined area. approximately 4 inches by 2.5/3 inches. There was pain within the area and radiating. I immediately took an aspirin and called my podiatrist thinking that the ankle boot was causing this. (the vaccine did not even enter into my mind) I had to leave a message on the machine at the podiatrist's office and received a return call within 2 to 3 hours by a RN telling me to go to closest ER ASAP. In the meantime while waiting to hear back, I remained seated with leg elevated . I went to ER. I was seen very quickly, ultrasound was provided to rule out DVT. By the time I reached the ER (approximately 1:30), the mass had significantly decreased. The ultrasound showed no DVT. The ER MD diagnosed most likely superficial blood clot and it would not have been caused by boot. Made contact with RN at PCP, she instructed me to file report with CDC.

After the second dose I had fatigue and arm pain so bad I could not do anything with that arm for like a week. Then it was gone. 2 weeks after things got really bad in a weird way. I went to a constant period where I only had a couple of days where I was not in my period. In May I ended up getting an infection, which was bacterial vaginosis and I went to the doctor around the 12 or 13, he prescribed me Clindamycin. The infection went away. Last month I got bacterial vaginosis, yeast infection, and constant period. I am not sexually active. I had just been in November to the doctor and been healthy in that area. I made an appt with the OBGYN on the 07/26 so I have not seen the specialist yet. A couple of days after making the appt I went to urgent care, Urgent Care because the pain was so bad, when they looked in there they said it was hard to see because of the blood. They said it looked like bacterial vaginosis and yeast infection and gave me metrogel and it also looked like an abnormality in there. They tested for bacterial vaginosis and yeast infection and said it was negative, and they did not have any idea of what was going on. I took the whole antibiotics and they went away for about a week and now is back again and my period came back again. It was 10 days without having the period. After the second dose when it got worse I am also in a support group for perimenopause women and a woman reported she also had the same symptoms as I did. They also did blood work at urgent care and it was normal. They were worried about the amount of blood that I lost.

death D69.6 - Thrombocytopenia, unspecified N93.9 - Vaginal bleeding JAUNDICE BLOATED SHORTNESS OF BREATH

I have been constantly sick since the day of the vaccine, first with pneumonia then consecutive cases of bronchitis. I have been through 3 courses of antibiotics, and 3 of steroids. Nothing clears my lungs up now. I have to do at least one albuterol treatment per day. I can hardly leave the house when it is humid outside, because I just cannot breathe. I have no quality of life anymore. I got the vaccine to keep from getting sick, and as a result I'm more sick than I've ever been in my whole life!!

One week after my first shot, I got my period and it was very heavy bleeding with clotting for days 2,3, 4 and some of 5. I had major back ache and the same thing but worse occurred one week after my second shot. I have bad periods but the last 3 years it?s gotten better where I don?t have to take Advil. I had to take advil for my last two periods which also gave me major Advil side affects such as pain in my spine into my neck and shoulders, sharp pains in my head and long lasting headache. Advil side effects went away after the second day I stopped taking it. I was taking 4 200mg pills a day 2 in the morning and 2 10-12 hours later. My period pains were extreme, worse I?ve felt in 3 years and I usually have bad pains and heavy bleeding but nothing like the two periods I experienced one week after each shot. I?m hoping my 3rd period isn?t going to like my last one because this was awful.

Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient. A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization. There were no known medical history or concomitant medications. The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN). Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, weakness, bone pain, abdominal cramps, loose stool--that had mucous and blood in it. Also had a small amount of vaginal bleeding/spotting not associated with her period. Multiple days of these symptoms.

Employee states that she received Dose #2 the day after the end of her menstrual cycle and that she began bleeding again after receiving her second dose and that it was a heavy and clotted cycle. She was advised to contact her OB/GYN

2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing with chest tightening, heart racing, numbness and tingling on my mouth and chin, tongue swollen and turned grey in a matter of a few minutes. I took Benadryl, an epinephrine pen, and a nebulizer and began to start feeling better in 15 minutes. Following the 2 weeks I felt nauseous, chills, cold sweat, lightheaded, weak, tired, headache and pain in arm/shoulder.

Healthcare was advised that this patient expired approximately two weeks after receiving her initial COVID vaccination

Injection given at 0917 and at 0925 she was coughing and felt someone wrong with her breathing and had increasing mucous. Pt stated this is how she feels when she has an anaphylactic reaction. HR was 122 and B/P 155/93. Benadryl 50 mg given at 0930, and epi given at 1001. Solumedrol at 1032 O2 99% at 1034. ACLS transfer to ER.

Pt reports menstruating during the first Covid vaccine on 1/19/21 and experiencing an increase in vaginal bleeding for 24 hours requiring changing a tampon every 30 min for 24 hours Pt reports not menstruating at the time of the 2 nd covid vaccine 2/8/21 but experiencing heavy vaginal bleeding for 24 hours

pt reports having a heavier than normal vaginal bleeding/menstruation with the first dose on 1/19/21 which lasted 24 hrs Pt reports not menstruating when receiving her second dose on 2/8/21 but did experience heavy vaginal bleeding that lasted 24 hours.

That same evening I began to be more short of breath and just didn't feel good. I had lethargy and general malaise. I had pleuritic pain in my right upper back that was a sharp pain with inspiration. All of this continued to get worse over time and I developed pneumonia. I wasn't able to go back to work from 1/27/21 to 3/6/21.

PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first shot, she complained of body soreness, weakness and headaches that did not go away until she had the stroke on 03/12/2021". Patient is now hospitalized and unresponsive.

47-year-old female presented for anaphylactic allergic reaction after getting her first dose of Covid19 vaccine. Patient was initially seen by Dr., who then signed out to me pending observation and reevaluation. In summary, patient had received total of 2 EpiPen 1 at home and 1 in the ED in conjunction with soluMedrol, Benadryl, and Pepcid. Patient has history of anxiety and jittery as well as nervousness after epinephrine. Patient was then given 1 mg p.o. Ativan for her symptom. On my evaluation, patient is not in respiratory distress, She is still Tachycardic in the 110s-120s Which is likely from the EpiPen. Patient stated that she normally stays tachycardic for a while after the epipen. Patient otherwise not in respiratory distress, her posterior pharynx and her uvula is not swelling. Patient also has no wheezing on auscultation exam. We discussed the possibility of staying in the hospital under observation versus going home. Patient reported she is back at baseline and would like to be discharged and I was in agreement with this plan. Patient does has 3 more epipen at home to use for worsening symptoms. She will be prescribed medrol dose pack. Red flags signs and symptoms were discussed with strict return instruction were given. Patient verbalized understanding and was in agreement with the plan. She was then discharged in stable condition.

Woke up with pain in left leg lower calf on February 26 one week after my second vaccine. Had pain and throbbing in leg couldn?t sleep with pain so on the evening of March 3rd I went to urgent care . Doctor didn?t think it was blood clot because I had no swelling or redness in my leg but gave me a script for ultrasound. I couldn?t get an appointment until the morning of March 5th . Was diagnosed with a very large blood clot in lower leg going up past my knee. I am now in Eliquis blood thinner for 3 months while they run tests

Prior to the shot, my idiopathic anaphylaxis has been in remission. Since the shot, my throat and tongue have been swollen. I cannot be around certain smells because my tongue and throat start to swell.

itchy face Narrative: Moderate anaphylaxis reaction after administration of dose #1 Pfizer covid-19 vaccine. Tongue swelling and facial itching. Epi administered xl, patient transported to local ER for follow-up care.

"1423 History of present illness-patient is a 47-year-old female with a significant past medical history presenting to the emergency department with large reaction. Patient received the Pfizer colored vaccination approximately 45 minutes prior to ED arrival. Patient had hives, throat swelling. EpiPen and Benadryl were administered. Patient has had significant improvement in her symptoms. Currently note throat swelling or shortness of breath. Hives markedly improved. [SM] 1425 Medical decision making-47-year-old female presenting to the emergency department with allergic reaction. Likely anaphylaxis given airway involvement. Covid vaccination was likely trigger. Will administer Pepcid and prednisone. [SM] 1426 Patient has been improving throughout the 2-hour ED stay. Will discharge with prescription for prednisone as well as EpiPen. Patient instructed to follow-up with PMD. She expresses a full understanding of the plan and is amenable to it. Strict return precautions given. All questions answered. "

There were no noted adverse signs or symptoms at the time of vaccination. Fiance of patient called Public Health on 4/12/21 to report the patient died in her sleep overnight on 4/7 or 4/8. Autopsy not performed, body embalmed prior to Public Health's knowledge of client death. Pfizer BioNTech COVID-19 Vaccine EUA

Started having headache, chills and body aches on 4/1/2021. On 4/2/2021 I had major fatigue. On 4/4/2021 my right leg began to swell terribly and then on 4/6/2021 it was discovered that I had one big and many small blood clots in my right leg.

while sitting right arm went numb, then couldn't get words out to speak and was confused; was taken to hospital and given tests (MRI, CT scan, COVID test, echocardiogram, chest X-ray); numbness went away first day, MRI showed TIA/mini strokes on left side of brain and insula part of brain; had aphasia for two days; admitted to hospital for observation and released after 3 days; given Lipitor and aspirin and heparin shots for treatment; no lasting effects from stroke; doctor says cholesterol, blood pressure and family history normal;

Blood Clots; Pulmonary Embolisms; DVT (Deep vein thrombosis); This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ENG207), dose 2 via an unspecified route of administration, administered in Arm Left on 25Mar2021 10:00 (at the age of 47years) as single dose for Covid-19 immunization. The patient received the dose 1 of BNT162B2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 08:30 (Batch/Lot Number: ENG203) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included essential tremor, insulin resistance, and anxiety; all from an unknown date and unknown if ongoing. Concomitant medications included propranolol, metformin, bupropion, and citalopram; all taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced blood clots, pulmonary embolisms, and a DVT (deep vein thrombosis) on 04Apr2021 (11:00AM). The patient was hospitalized due to the events for 4 days. The patient was treated with Heparin and Eliquis. The patient was tested for Covid-19 post vaccination via Nasal Swab on 03Apr2021 with Negative result. The outcome of events was recovering. The adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event).

High/Drunk feeling within 1 hour of shot, Not able to sleep at night for first 72 hours (2 hrs 1st night, 4 hours 2nd night, 4 hours 3rd night), Very low mood and wishes I would die on 4/15 morning as pain/discomfort was so great. Severe Chills (shaking, needed 3 blanket) from late afternoon to early morning hours during the 1st 72 hr post injection, Severe night sweats 1st 3 nights - body was soaking wet and soaked through pajamas, Joint and muscle pain in arms, legs, face/jaw starting the 1st night after injection and continuing for 4 days after injection, Swollen, painful lymph nodes in under arm/neck - continues to this day (started night 1 and now 9 days after injection), Occasional dizziness when standing and sitting starting 4 days after injection and continuing for 48 hours, Blurred vision, people looks like they were swaying starting day 5 through day 6, Very Heavy vaginal bleeding started on day 7 (4/20), got worse on day 8 (4/21), and the same on day 9 (4/22): soaking through pad every 2-3 hours on day 8 and day 9. bleeding continues at time of this report. NOT like a period, or timing of my period. My period is not due to start until 4/25 and I have been regular my entire life - 36 years! Cough and left arm pain started on day 8 (4/21) - I went to ER after calling my OBGYN and talking with the nurse. NEVER had a fever, NEVER had cramps.

Patient received her second Pfizer vaccine on 4/12/2021. On 4/19/2021 patient had a localized right sided tonic-clonic seizure, evaluated at local ER. Patient has no prior history of epilepsy or seizure disorder. Patient has no history of drug/alcohol use.

tia in right eye, on Friday morning on 4/16/ 21, between the hours of 8 am and 9:30 am, I went from feeling fine and sleeping to waking up not being able to hear in both ears, not being able to see anything out of my right eye, my left arm was completely number all the way up to my shoulder and neck, the right side of my tongue was numb and my blood sugar was over 611. Initially they thought it was just a reaction to my high sugar levels, since the mri's showed I did not have evidence of a stroke. It wasn't until I saw a retina specialist the following Tuesday that she confirmed that yes I did have a stroke in my eye. I have not recovered my vision fully in my eye or the sensation in my tongue. I didn't connect it to the vaccination until I spoke with a friend whose sister also got pfizer 5 days before me and suffered a stroke 3 days before me, and two days after we spoke they announced Johnson& Johnson pause due to clots in women. The retina specialist says we will have to wait and see if the damage heals on it's own in the meantime I need to see her on a monthly basis.

Patient had an anaphylactic reaction to the Pfizer Covid19 vaccine. She had chest tightness in the first 10 minutes and received two oral Benadryl capsules. At about 20 minutes post vaccination, she then felt her throat swelling up and we then had to give her three epipens. Her symptoms included chest tightness, shortness of breath, coughing, and eventually throat swelling, which resulted in a brief, repeated loss of consciousness.

I had a tattoo done on Sunday night (4/18). I have had many tattoos before this. The first two days of healing went great, but I woke up on Thursday morning with horrific symptoms. Weeping fluid and ink to the point where my skin was coming off in sheets. Extreme pain, swelling and bleeding. I assumed it was an infection or an allergy, but it is not infected. I don't think it was an allergy, unless it was a mild allergy exacerbated by the vaccine. Healing has been truly terrible and I'm still on the road to recovery now.

The decedent was found in her bedroom by her daughter. Medical history only includes previous blood clots. Decedent has been complaining of coughing and shortness of breath the past few days. There is no history of drug use. The decedent had a foam cone when found.

died on 14Apr2021 01:30 pm of a sudden death; first dose of BNT16B2 on 15Mar2021 09:00 am/ second dose via an unspecified route of administration on 02Apr2021; first dose of BNT16B2 on 15Mar2021 09:00 am/ second dose via an unspecified route of administration on 02Apr2021; This is a spontaneous report from a contactable healthcare professional (patient's spouse, nurse practitioner). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 02Apr2021 (lot number: EW0150) as single dose (at the age of 47-years-old) for COVID-19 immunisation, vaccinated at a hospital. Medical history included hypothyroidism, anxiety, and chronic migraine (ongoing). The patient had no known food and drug allergies. Concomitant medications included levothyroxine sodium (SYNTHROID); sumatriptan for migraines; and clonazepam for anxiety. The patient received the first dose of BNT16B2 on 15Mar2021 09:00 am (lot number: EN6708) (at the age of 47-years-old) for COVID-19 immunization. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient died on 14Apr2021 01:30 pm of a sudden death. She was found at home unresponsive and pulseless. Efforts at resuscitation were unsuccessful. Her medical history of hypothyroidism, anxiety and chronic migraines do not appear to be contributory. The patient did not receive treatment (as reported). The reporter considered the event to be a serious adverse effect (SAE). A full autopsy has been performed; the results were pending.; Reported Cause(s) of Death: died on 14Apr2021 01:30 pm of a sudden death

Pt states that she developed right forearm pain and swelling the day after. She was seen by me on 4/29/21 and diagnosed with DVT radial and cephalic veins. Also with SVT of the fore arm.

After 2 days of receiving my first COVID vaccine, I started my menstrual cycle. My cycle was very heavy with large clots. It lasted four weeks. Very unusual, I never had a menstrual cycle like this before.

I felt light headed shortly after leaving or within the 1/2 hour after vaccine. Later that evening i had a migraine. The following day another migraine. It went away and Monday it returned. I began taking Aleve and it eventually stopped. The Thursday after vaccination (4/15/21) i woke up full of blood like a period however it was not time for my period and the bleeding went away early that morning. Every other day after that i was getting spotting and i am still getting it. At the same time the bleeding started, i was having knots in my stomach that made me have multiple bowel movements daily. Every thing i ate would send me to the bathroom a few hours later. I have chronic constipation and have bowel movements usually 2-3 times a week but this vaccine had me going 2- 3 times a day . This lasted from until a day before i was due for my 2nd vaccine. I had the second dose 4/30/2021 and had no issues until today when the stomach knots and multiple bowel movements resumed. I am hoping it's going to pass quickly since i had no issues from the second dose. It was the first dose that was awful for me

Menstrual irregularities. Light spotting for at least one full week (never experienced). Heavy bleeding and clotting (currently happening). This is day 16 of this. I have experienced heavy bleeding in the past but it only lasts 2-3 days at the most (usually only 2 days). Clotting is heavy unlike anything I've ever experienced. Minor soreness of nipples shortly after 1st vaccine, which was constant for 4 weeks but has since stopped (this has never happened).

Onset diffuse bruising prior to presentation to emergency department. Platelets = 2,000. Acute ITP diagnosed.

multiple bilateral pulmonary embolism; shortness of breath; elevated heart rate; elevated blood pressure; decreased oxygen saturation; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 47-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 15Apr2021 at 10:30 (at age of 47 years old, no pregnant, Lot Number: EW0151) as a single dose for covid-19 immunization. Medical history included hypertension, known allergies Amoxicillin, sulfa, Keflex. Concomitant medications included losartan and omeprazole. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Apr2021 at 09:00, reported at 11 days post vaccine experienced shortness of breath, elevated heart rate, elevated blood pressure, decreased oxygen saturation. Diagnosed with multiple bilateral pulmonary embolism. No typical risk factors. Awaiting results of tests for protein s deficiency/factor 5/lupus. No family history of any. The events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care/ Life Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized from 26Apr2021 to 29Apr2021. The treatment received with IV heparin, now oral warfarin and Lovenox shots. The patient underwent lab tests and procedures which included SARS-CoV-2 test (SARS-CoV-2 test): negative on 28Apr2021, negative on 30Apr2021 and pending result on 02May2021. The outcome of the events was not recovered.

Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling across face just above upper lip; face and neck turned red and swollen/ arms turned red under sleeves; face and neck turned red and swollen; dizzy; brain fog; Existing Tinnitus in left ear is louder; This is a spontaneous report from a contactable consumer reported for herself. This 47-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 15:15 (Batch/Lot Number: Unknown) as single dose (at 47 years old) for COVID-19 immunisation. Medical history included fibromyalgia from (previously diagnosed as Rheumatoid Arthritis). Concomitant medications included fenofibrate, escitalopram, hydrochlorothiazide, losartan potassium (LOSARTAN/HCT), herbal sup, all taken for an unspecified indication, start and stop date were not reported. The patient previously took monosodium glutamate and experienced allergy, hydroxychloroquine sulfate and experienced allergy. On 27Apr2021 15:15, the patient experienced anaphylaxis, vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen/ arms turned red under sleeves, dizzy, brain fog, existing tinnitus in left ear is louder, all with outcome of not recovered (as reported). Therapeutic measures were taken as a result of the events included Diphenhydramine, Epinephrine, Famotidine, Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient stated that: "Sent to ER via ambulance: Diagnosed with Anaphylaxis. Vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen, arms turned red under sleeves, dizzy, brain fog. Existing Tinnitus in left ear is louder, and as of 04May2021, I still have the headache". Seriousness criteria of the events was reported as serious due to disability. The information on the Lot / Batch number has been requested.

Site: Pain at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Period was unusually heavy and had lot of clots. Not normal for her-Severe, Additional Details: Pt had to get a Toradol shot for a migraine in the left arm 6-7 days after the shot in the left arm that was vaccinated. She ended up getting a red , ropey looking line starting from the injection site up her arm that also had knodules going up that line as well. So she thinks that the heavy period with a lot of clots was caused by the injection and that the phlebitis of the left arm was possibly from the shot as well because she has had other IVs in her arms before that did not cause reaction

2 weeks post second vaccine with pericarditis (classic positional chest pain and pericardial effusion); 2 weeks post second vaccine with pericarditis (classic positional chest pain and pericardial effusion); 2 weeks post second vaccine with pericarditis (classic positional chest pain and pericardial effusion); This is a spontaneous report from a contactable Physician (patient). A 47-year-old female patient (pregnant: no) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in right arm on 20Jan2021 (lot number: EL3302) at 19:00 at single dose for COVID-19 immunization. The relevant medical history included CSF leak (Cerebrospinal fluid leakage) from an MVA, depression, asthma, reglan allergy and COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19?: Yes). Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), montelukast sodium (SINGULAIR), fexofenadine hydrochloride (ALLEGRA), fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL) and temazepam (TEMAZE). The patient experienced 2 weeks post second vaccine (as reported) with pericarditis (classic positional chest pain and pericardial effusion) on 30Jan2021 at 12:00. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included prednisone, colchicine, aspirin and anakinra, received for the adverse events. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was not recovered.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Pericardial Effusion, pericarditis, Chest Pain and the suspect BNT162B2. 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 was described as having a "Grand mal" seizure within 15 minutes of vaccination. Patient was observed, refused transport to ER, and was released to home when she felt better.

After first dose her mental status become slightly altered and she leaned to the left a bit when standing up and walking.. From the day of second dose my sisters appetite decreased. She started sleeping more, got weaker to the point I had to bathe her, she had to start using a wheelchair. Mental status much more altered. She was to weak to go to dialysis on Monday March 22 2021 hospice was called in Tuesday March 23 2021 and she passed away at approximately 4:00 P.M. March 24th 2021.

severe pain when breathing which resulted in bilateral pulmonary embolisms, DVT in right calf, non-occipital; severe pain when breathing which resulted in bilateral pulmonary embolisms, DVT in right calf, non-occipital; severe pain when breathing which resulted in bilateral pulmonary embolisms, DVT in right calf, non-occipital; This is a spontaneous report from a contactable consumer reporting for herself. A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 07Apr2021 at 08:00 (Batch/Lot Number: EP7533) (at the age of 47 years old) as a single dose for COVID-19 immunisation. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 08:00 (Batch/Lot Number: EN6204) (at the age of 47 years old) as a single dose for COVID-19 immunisation. Medical history included factor v deficiency from an unknown date and unknown if ongoing, protein c deficiency from an unknown date and unknown if ongoing. The patient did not have any known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included venlafaxine hydrochloride (EFFEXOR XR) taken for an unspecified indication, start and stop date were not reported; ibuprofen taken for an unspecified indication, start and stop date were not reported; diclofenac potassium (VOLTAREN ACTI) taken for an unspecified indication, start and stop date were not reported; spironolactone (SPIRONOLACTONE) 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. On 12Apr2021 at 14:00, the patient experienced severe pain when breathing which resulted in bilateral pulmonary embolisms, deep vein thrombosis (DVT) in right calf, non-occipital. The events severe pain when breathing which resulted in bilateral pulmonary embolisms, deep vein thrombosis (DVT) in right calf, non-occipital required a physician's office visit, emergency room visit and hospitalization for 1 day. The outcome of the events severe pain when breathing which resulted in bilateral pulmonary embolisms, deep vein thrombosis (DVT) in right calf, non-occipital was recovered in Apr2021. Since the vaccination, the patient had not been tested for COVID-19. Follow-up needed, further information has been requested.

Blurry vision and( flashing light in peripheral vision )right eye the next day after receiving the second dose on April 27,2021. Flashing light lasted for a week. Afterwards just blurry vision until May 30th vision became distorted and dark. Visited eye specialist 06/04/2021 and was advised to report to the CDC that blood clot was found in right eye. Treatment is now needed that involves injections to the right eye . (3 treatments in span of 10 weeks) with possible laser treatment if injections are not as effective. Eye Specialist -

Monday April 5th I started bleeding. I thought it was my normal period. Tuesday I started having major abdomin pain. It was so bad I couldnt walk. The pain would subside and then I would bleed alot. Then the pain would start again. The pain would subside and I would start bleeding alot again. This was like labor. Wednesday I had a lot of tissue come out of me so I realized this must be a miscarriage. My doctor told me to take a pregnancy test and sure enough it tested positive I was about 5- 7 weeks pregnant. As far as pregnancy history, I also miscarried February 11th. (went in for the ultrasound and fetus wasnt moving around 9 weeks). Had first child at 35 and 2nd at 40. My instincts tell me the vaccine had something to do with my 2nd miscarriage (April 5th).

became unresponsive, intubated in the field with CT images revealing a diffuse SAH, IVH, cerebral edema, brain compression, possible aspiration pneumonia o Admit to NICU s/o Doctor o Consult Doctor for CC o Neuro checks q1h o SBP < 110 o Mannitol 50g IV x1 stat than 3% HTS for NA goal 145-155 o EVD placement ASAP o Amicar 5g stat o COVID PCR negative o Labs/ medications as ordered o SAH protocol o Plan for cerebral angiogram and possible coiling in am with Doctor.

Presented with muscle pain in left shoulder and left side that got progressively worse over a few days. Went to Orthopedic Walk-In clinic on 4-27-21. Clinic did x-rays with no findings and treated with prescriptions for muscular related problem. Went to pharmacy to pick up scripts after Clinic appt. While waiting for my scripts to be filled I started having shortness of breath and pain in my chest. Went to Memorial ER and they did chest x-ray and CT Scan and determined I had Blood Clots in both lungs. Treated with blood thinner and admitted overnight. Discharged 4-28-21 with prescription for Blood Thinner.

Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Additional Details: Unsure what type of reaction she was experiencing. The agent from the state health department indicated patient was experiencing a severe reaction. The patient received a COVID and Tdap shot on the same day.

Deep vein thrombosis left leg, Lovenox f/by Pradexa. On 5/28/21, received pfizer covid vaccine 2nd dose. On 5/29, visited . on 6/1/21, noted Lf leg pain. 10 days later, noted severe pain and swelling. ED visit on 6/11/21

History is provided by the patient. This is a 47 year old female with self reported past medical history of nephrolithiasis who presents to the ED with concerns for allergic reaction. Received second dose of the COVID vaccine around 08:00 am this morning. About 20 minutes later, she started to feel constant shortness of breath in addition to feeling like she was going to pass out with associated nausea and tingling to her hands and feet. No modifying factors reported. She presented to the ED for further evaluation. She had a similar reaction on receiving her first dose of the COVID vaccine, but notes this episode feels worse. Lungs are clear to auscultation. No signs of angioedema. No clinical signs of an allergic reaction. Due to patient's complaints, will provide Solu-Medrol, Benadryl, and famotidine. Will also obtain EKG. Discussed indications for epinephrine, will hold off epinephrine at this time and re-assess. 09:33- On re-assessment, patient now with periorbital edema. Airway still intact and voice is clear. However, will provide epinephrine now. The patient was treated with intravenous fluids (IVFs) for the following reason: concerns for dehydration, dry mucous membranes. Patient improved after IV fluid administration. Patient is reassessed multiple times, with improving symptoms At 4 hours status post epinephrine, patient with no rebound symptoms, patient states that she is feeling better, ready for discharge home. Due to anaphylaxis, will provide additional epinephrine prescription for home. Allergy added to patient chart.

Later that afternoon I felt like a ton of bricks hit me. Almost like I was going to faint. When I got home my arm was swollen and red. I started having a bad bowel movement, no fever, stiffness, joints aching, and dull aches. I had a hard time resting. The next day when I woke up, I had a bowel movement bad. When I went downstairs, I was bleeding from light to medium from my vagina. For 4 hours I had sharp pains in the middle of my chest. I went to see Doctor; my symptoms were gone for 5 days. Then 10 days ago my eyes were tearing a lot and painful. I went walking and had incredible pain in feet, ankle, knee, and I could barely stand. The next morning, I went to my PCP and referred me to a RA doctor and think it's an autoimmune disease.

I had the tired symptoms and fatigue next day. They got worse and i had memory issues, speech problems, stroke symptoms and severe migraines. I missed 3 weeks of work off and on in May due to all this. I ended up in the ER on May 14 for stroke symptoms and lost use of my right arm and hand for several days. I have been diagnosed with migraines with aura and told I had a severe reaction to the shot and may recover in 6 months. I am on all new meds to try to control my migraines which are now daily and more severe than ever.

The patient experienced chest pain/heaviness in addition to interscapular stabbing pain radiating into both arms approximately 23 days following her second dose of the Pfizer vaccination. She was taken to the cardiac cath lab after negative troponins and a negative stress test. Two coronary stents were placed in the setting of single vessel disease. She suffered a mild myocardial infarct during angioplasty. The patient was transferred to the facility where I work due to persistance of bilateral arm/hand dysesthesias/numbness/tingling which did not resolve following angioplasty/stenting. She demonstrated a poorly-definted mid-thoracic sensory level described as abdominal numbness extending to the legs. She demonstrated widespread hyperreflexia, including crossed adduction with bilateral knee jerk reflexes. Her presentation was consistent with acute transverse myelitis. As of outpatient follow-up on 4/12/21 the patient had continued dysesthesias and a subjective sensory level similar to presentation.

I was prepping for a colonoscopy at the hospital, I had ketoacidosis. In the process of being there, my chest began to hurt. They did a chest x-ray and it showed I had pneumonia. I did not know I had pneumonia. I was in the hospital from 06-28-2021 till 07-01-2021. I was surprised I had pneumonia. They did a Covid test and I was negative. I will have a follow up with my doctor. I still have a cold and some breathing difficulty.

I?ve been in menopause since May 2019. On June 4,2021 10 days after my first dose of the Pfizer vaccine I began to have post menopausal bleeding for nine days. It stopped on June 10, 2021. I was clotting during that period as well. I?ve since had a vaginal ultrasound and pelvic MRI with no signs of cancer or anything else that would cause post menopausal bleeding.

6/30/21, 20 minutes after headache and fatigue. More tired that usual over next few days and hard to concentrate. 7/2/21-7/13/21 twitching in my legs upon waking (think activated bartonella bacteria from lyme co-infection), 7/3/21-7/8/21- circulation poor in lower legs-had to move around a lot, veins protruding from lower legs-which I've never had before and some swelling in ankles, feet and fingers, 7/1/21 heart beating fast going up flight of stairs but quickly went back to normal also got menstrual cycle 10 days early- was heavier with blood clots (typically 28 day cycle), bruise under area received vaccine

The next day(Friday) after my first Pfizer covid vaccination, in the evening around 7pm I started experiencing trouble breathing and pain in my right leg. I was also very tired. At first I thought it was a reaction to the medication. By Saturday, it was so bad I could not work more than few steps without feeling and breathing like I had ran a marathon. Monday I made an appointment with my doctor for the following Wednesday March 31. I also went for a Covid test Monday at a drive through. That test was negative. By Wednesday, it was so hard to walk into my doctor appoint. I was exteremely fatigued and out of breath. My legs no longer hurt though. My doctor took one look and sent me to the hospital for several tests. The tests determinted I had several small Pulminary embolisms (in my legs) including a saddle embolism which is very danger and a couple of larger clots in my right leg. I was admitted to the hospital and put on high doses of blood thinners. I have to take eloquis for an undeterminted amount of time and wear compression socks for the next two years. My doctor also told me not to get the 2nd Pfizer Covid vaccination. She and I both think that possibly the combination of my birth control and the vaccination caused the blood clots.

3 weeks after 4/15 I started having vaginal bleeding at first I thought it was my menstrual cycle but it has not stopped. It is like a normal period but it has not stopped. I was put in different hormone prescription but they have not helped.

anaphylaxis/allergic reaction; Mast Cell Activation Syndrome; Drug Hypersensitivity Syndrome; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; Intolerances to medications which has now expanded to food, exertion, scents, and temperature changes; This is a spontaneous report from a contactable consumer (patient). A 47-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left at age of 47 years, not pregnant on 19Mar2021 14:00 (Lot Number: Pfizerep7534) as single dose for covid-19 immunisation. Medical history included allergies to penicillin prior to vaccine and traumatic brain injury from near fatal accident. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) taken for birth control; fluticasone propionate (XHANCE). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had an anaphylaxis/allergic reaction to the first Covid Pfizer vaccine shot, (her only shot) on 19Mar2021 and since then things had spiraled out of control with her body; many medications to treat had caused more anaphylaxis allergic reactions like Benadryl, Cromolyn and Famotidine/Pepcid (7meds in total as she had been on no new meds since). She presented with Mast Cell Activation Syndrome and Drug Hypersensitivity Syndrome. 5 ER visits, 2 hospital stays and no improvements. The only medications that seem to provide any relief. Hydroxyzine, Singulair and Prednisone and even with these medications she continue to have allergic reactions or intolerances to medications which has now expanded to food, exertion, scents, and temperature changes. Not sure why this was happening, as prior to 19Mar2021 no food allergies and never had anaphylaxis until then. Patient in need of treatment by a vaccine expert. Her body saw everything as a toxin. Adverse event started at 19Mar2021, 14:00, and 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). Hospitalization for 7 days. This case was serious with seriousness criteria reported as life threatening and caused hospitalization. Prior to vaccination, the patient was not diagnosed with COVID-19. Covid test via nasal swab on 12May2021 was negative. The outcome of the events was not recovered.

Patient received both doses of the Pfizer vaccine on 2/24/21 and 3/17/21. Patient came to the ER on 5/8/21 with chest pain, where she tested positive for COVID. While patient was receiving a precordial drain she went into V. tach but was successfully resuscitated. She went to ICU but went into cardiopulmonary arrest and died on 5/9/21.

Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: employee with an adverse reaction to the Covid vaccination. Reported to RN 10 minutes post vaccination Lips numbness/ tingling, throat fullness and slightly anxious. NP assessed employee and 50mg of IM Benadryl given in the opposite arm (right). No SOB or wheezing noted. VS pre treatment 158/99, 98%-RA, 98-HR, 18-RR. Ten minutes post treatment Lip tingling and throat fullness improving. At 20 minutes post treatment all S&S of adverse reaction resolved VS taken throughout even with 60 minutes of observation time total VS 139/84, 99%-RA, 81-HR, 14-RR. She is feeling tired and will consider calling for a ride to go home as advised by staff.

anaphylactic reaction; neuropathy in fingers, toes, roof of mouth/lips; This is a spontaneous report from a contactable nurse (patient). This 48-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL0140) at single dose on left arm on 30Dec2020 at 09:00 for COVID-19 immunization. Medical history included asthma (controlled); hypertension diagnosis 1 year ago; allergies to medications, food and environmental. Concomitant medications in two weeks included antihypertensives - amlodipine and losartan. 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 not been tested for COVID-19. On 30Dec2020 at 9:15 AM, the patient experienced anaphylactic reaction within 10 minutes of administration, neuropathy in fingers, toes, roof of mouth/lips. Neuropathy continued to date. The adverse events resulted in emergency room/department or urgent care. The patient received treatment Epinephrine IM (intramuscular) and IV (intravenous) steroids. The outcome of events was recovering.; 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 anaphylactic reaction and neuropathy peripheral 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 serum tryptase and nerve conduction studies, 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.

Anaphylactic reaction with EpiPen administration in vaccination clinic, followed by Rapid Response Team initiation and immediate transport to Emergency Room.

Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday morning, I was aching all over and still had a headache. The aches were so severe that I was unable to tolerate anything or anybody touching me. By that afternoon, I was weak and fatigued. I was sent home by my director and by that evening I had developed a temp of 101.0. Friday morning, I was not feeling any better so I went to Urgent Care at around 0800. COVID test was negative but possibly too early to detect. Here we are today and I am still having body soreness that has become unbearable. I went to the walk-in clinic here at the hospital and have now been told that I will have to be admitted based on my lab results that indicates rhabdomyolysis.

Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, only prior sensitivity to Avocado. During clients 15 minute wait she stepped outside complaining of being hot. A nurse provided water for client, as well as juice. She stated she felt better. Nurse accompanied her back in side, and went over other signs and symptoms of anaphylaxis. Client stated she was not experiencing any of those symptoms and that she felt better. When her wait was complete, she walked to the coat room with other employees, and her throat and ears began to itch, and she was coughing to help itch her throat. At this time the vaccine director was alerted and anaphylactic protocol was initiated. EMS was called- the time was 4:37 pm, pulse was 80, blood pressure was 178/108. 4:39- client refused epi, so 1mL/50Mg, IM Benadryl was given in the right deltoid. Simultaneously, a tourniquet was placed above the vaccine site on the left deltoid. Distal pulses monitored in left arm every 5 minutes. 4:41 itching and coughing increased, client agreed to Epi. 0.3 mg Epi pen given in right thigh. EMS arrive and transported client to hospital for observation.

Site: Itching at Injection Site-Severe, Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Medium

chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking. anaphylaxis EKG monitoring, IVF, IM Epinephrine, IV Benadryl, IV Pepcid, Albuterol dual neb, CXR, Labs sent home after 6 1/2 hours of treatment and monitoring. Sent home with Epi pen

Acute pancreatitis with sepsis; Acute pancreatitis with sepsis; This is a spontaneous report from a contactable pharmacist, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 17Dec2020 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fexofenadine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020, the patient experienced acute pancreatitis with sepsis, which were reported as serious for hospitalization and being life threatening. The patient had gone to the emergency room due to the event and was hospitalized for a total of 6 days. On 29Dec2020 and 31Dec2020, the patient had COVID-19 nasal swabs performed and both results were negative. Therapeutic measures were taken as a result of acute pancreatitis with sepsis and included gall bladder removal. The clinical outcome of acute pancreatitis with sepsis was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events pancreatitis with sepsis with BNT162b2 can not 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.

Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest pain left side Jaw pain left side Kidney pain left side Headache Was given Nitro pill and 3 1/2 baby aspirin by paramedics at testing site. Another Nitro pill in ambulance on the way to hospital. Treated for heart attack dueto Vaccine

After ten minutes my throat began to feel swollen, a feeling of a lump in my throat. After around 20 minutes I also began to feel more light headed/dizzy. I was moved to be observed by a nurse for another 20 minutes and when symptoms did not subside I was moved to the Emergency Department where they administered Epinephrine at 9:27am, Pepcid, 9:24am, Solu-medrol 9:24-10:50am. Diagnosis: Anaphylaxis. Dr. wanted to prescribe Benadryl IV but I declined as I needed to drive home and the facility was far from home. I was discharged around 1:00pm. A prescription for an Epi Pen was made by Dr. and filled that day at pharmacy. and spoke to my Dr. at another healthcare organization at 4:30pm. Benadryl OTC was then rx'd by my primary care doctor at 4:30pm-50mg every 6 hrs moving to 25 mg every 6 hours the next day. Symptoms of swollen throat continued into the next day and have not yet abated but also have not worsened. Due to continued throat swelling I have taken 50mg of Benadryl the next day as well. Dr. my primary care Dr. scheduled an allergist appt for Feb. 3, 2021 and advised I should not get the second dose of the COVID19 vaccine until I speak with an allergist and have a treatment plan developed.

Intense soreness/pain in muscles ( arms, under breasts rib area, thighs, lower legs and ankles), blood in urine, pain in all major joints. difficulty walking and limited range of motion. Symptoms showed up after 7 days after vaccine was received. Presented to urgent care after test were don't I was hospitalized inpatient for 4 days. I was diagnosed with RHABDOMYOLYSIS, ABNL LIVER FUNCTION STUDY. CREATINE KINASE TEST OUTCOME WAS AT 41000.

Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram after finding brain bleed. Once released home from brain bleed patient developed petechai, weakness, shortness of breath

patient was not vaccinated at hospital. Caregiver reports that patient was vaccinated with second dose on Monday 2/15/21. Tuesday patient experienced n/v/d. Went to an ED on Wednesday and was cleared and sent home. Thursday reported shortness of breath to her caregiver and then collapsed. Patient was brought to as PEA arrest and ultimately died.

anaphylactic shock; BP 209/109 within 15 minutes of the shot/elevated BP; major headache; This is a spontaneous report from a contactable other HCP. This other HCP reported for herself that a 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 48-years, via an unspecified route of administration in left arm on 28Jan2021 10:30 at single dose for COVID-19 immunisation. Medical history included nerve damage; multiple surgeries from a wreck. Patient was not pregnant, was not pregnant at time of vaccination, there was no other vaccine in four weeks. No COVID-19 prior vaccination. Concomitant medications included duloxetine hydrochloride (CYMBALTA); loratadine (CLARITIN); colecalciferol (VITAMIN D); ascorbic acid (VITAMIN C); probiotics nos. The patient previously took rofecoxib (VIOXX), miconazole nitrate (MONISTAT), gabapentin, flu shot, all experienced allergies. At 10:45 AM on 28Jan2021, the patient experienced shortness of breath (SOB), BP 209/109 within 15 minutes of the shot, clammy, major headache. Received diphenhydramine hydrochloride (BENADRYL) on site and transferred by ambulance to hospital where she received Epishot, dexamethasone and ketorolac tromethamine (TORADOL). Diagnosed with anaphylactic shock. Went home with elevated BP and major headache. Daughter called an ambulance that night because the headaches were so bad. Ambulance driver stated they couldn't do anything for patient at the hospital unless she exhibited stroke like symptoms. BP stayed elevated for 2 days and headaches continued. Started to feel better 5 days later. Followed up with her PCP and patient was put on steroids for 5 days to taper down. The adverse events resulted in doctor or other HCP office/clinic visit, emergency room/department or urgent care. Patient received BENADRYL, epinephrine, dexamethasone, TORADOL as treatment for AEs. Lab data included: patient was tested negative for COVID-19 virus test (nasal swab) on 23Feb2021. Outcome of the events was recovered in Feb2021.; Sender's Comments: Based on the close temporal relationship, the association between the events anaphylactic shock, BP increased and headache with BNT162b2 use can not 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.

I received the first does of the Pfizer vaccine and within 24 hours had started developing a superficial thrombophlebitis on the inside calf of my left leg. By Sunday, February 28th, I was in the emergency room getting an ultrasound to rule out a blood clot. By March 11, I had developed a DVT. I have been put on blood thinner and had catscans, ultra sounds, and am under a physician's care weekly.

Intense pain in arm followed by joint pain 5 days later I have fever, loss of taste and smell, diarrhea, chills, disorientation, difficulty breathing

anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and ears; swelling of throat and ears; sudden drop in blood pressure; elevated blood pressure and heart rate; elevated blood pressure and heart rate; inability to breathe all within less than 30 minutes of injection during; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 17Mar2021 10:00 (Batch/Lot Number: EN6208) as single dose for covid-19 immunisation at a clinic. Medical history included asthma, allergies, and previous history of anaphylaxis to oral sulfa (Sulfa- anaphylaxis). Concomitant medications in two weeks included diphenhydramine hydrochloride (BENADRYL); clarithromycin (CLARTIN); levosalbutamol hydrochloride (XOPENEX); and fluticasone propionate (FLOVENT). There was no other vaccine in four weeks. On 17Mar2021 10:15, the patient experienced pounding of heart, tightness of chest, itching, coughing, hives, swelling of throat and ears, elevated blood pressure and heart rate, sudden drop in blood pressure, and inability to breathe all within less than 30 minutes of injection during observation. Epipen was administered on site and care team called 911. Ambulance arrived, assessed and informed her that she was experiencing anaphylaxis and took her to ER. ER gave her steroids and prescription for epipen and steroids. The next day itching, swollen throat, ears, pounding of heart and tightness of chest came back and she self injected epipen. Went to her doctor and was prescribed more epi pens, singular, Pepcid AC, and refilled her inhalers. She is to her seen again tomorrow by doctor. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and were assessed by reporter as Life threatening illness (immediate risk of death from the event). Treatment for the events include Epipen, steroids, Pepcid AC, singular, inhalers. The outcome of the events was not recovered. The patient was not pregnant at the time of event onset or at the time of vaccination. Patient had no COVID prior vaccination and was not tested for COVID post vaccination.

Within a short time after receiving my COVID vaccination, I experienced a burst of energy, pretty severe abdominal cramping, and vaginal bleeding (small amount; very close location-wise to being internal but was external). Bleeding lasted until bedtime and was gone, along with the abdominal cramping and burst of energy by the next morning and has never returned. Vaccine #2 was on 2/9/21 and the only difference I felt after that one was tiredness; took a 3 hour nap shortly after I returned home and never noticed anything else since. (Not sure if this helps to know...I had a hysterectomy mid-October, 2020.)

Arm pain on first day Tendons stiffness on one arm and both wrists on second night 4th day - Early menstrual period ( 2 weeks early): sudden bright red bleeding without usual signs of menstrual periods (no cramps, very unusual), and large clots in the bleeding Nausea, 2nd day

Stroke; This is a spontaneous report from a contactable pharmacist. A 48-year-old female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 48-year-old, intramuscular, administered in right arm on 24Mar2021 13:00 (Lot Number: EL9262) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was previously vaccinated with the first dose of BNT162B2 (lot number: EN6202) at the age of 48-year-old, on 03Mar2021 at 12:00 PM intramuscularly administered as the left arm for COVID-19 immunization. The patient experienced stroke on 25Mar2021 15:00. The event resulted in emergency room visit and the patient was hospitalized on an unspecified date for 6 days. It was unknown if treatment was given. The event was also reported as life-threatening and disabling/incapacitating. The outcome of the event not recovered.; Sender's Comments: A causal relationship between the event stroke and suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) is possible based on the information provided, drug profile and a temporal association in this 48-year-old female patient. 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 RAs, Ethics Committees, and Investigators, as appropriate.

03/24/2021 11:00 AM - PM sore throat - 03/25/2021 around 3:40PM had massive stroke while alone. 03/26/2021 around 9:40AM broke window to get inside the apartment. Called ambulance, went to hospital, around 3:00PM transferred to other hospital and still there now. NO previous strokes Doctors have denied that the stroke is due to COVID 19 second vaccine. They also said that she will never be able to communicate but we have her on video. She has lying on her floor for 16 hours. The hospital also punctured her lung by inexperienced care givers trying to insert a feeding tube into her nostrils.

swelling, redness, and warmth in shoulder of right arm starting about 7-8pm on 04/08, patient went to emergency room on 04/09 where they did an ultrasound and diagnosed her with a superficial blood clot. they told her to take aspirin every day for one month and then return to doctor for a re-evaluation.

mini stroke; having vision issues; having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes; having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes; This is a spontaneous report from a contactable consumer (patient). This 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 23Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient received the first dose on 02Mar2021 12:15 on the left arm. The patient medical history was not reported. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING) for birth control. The patient previously took erythromycin and experienced allergies. Patient is not pregnant at the time of vaccination. 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. Patient has not been tested for COVID-19 since the vaccination. On 24Mar2021 8:15, patient started having vision issues, she could not focus and started seeing flashing that was moving from right to left in both eyes, this lasted for about 45 min. Her doctor had the patient go to the ER where they did a CT scan thinking of possible mini stroke, no signs of that scan came back clear. AE resulted in emergency room/department or urgent care. No treatment received for the adverse events. Patient recovered from the events on 24Mar2021 09:00. No follow-up attempts are needed. No further information is expected.

Started to have body aches, head aches and neck pain from next day morning and keep on progressing the symptoms even after 4 weeks. So tested for Covid on 2/23/21 and was positive. Also tested positive on 11/2/2020 and recovered in 3 weeks. My allergies increased in frequencies and intensity during last 12 weeks and had a severe anaphylactic shock 3 weeks ago which required calling 911 and ER treatment for stabilization. Till today, I have body aches, neck pain, insomnia and head aches and I am doing everything in my knowledge to improve my health. Multiple doctors and specialist appointments, are still continuing for treatment .

DVT Left calf. Started as pain in the left calf on morning after vaccination. Seen by PCP 1 week later with persistent pain. Diagnosed by ultrasound. Confirmed by hematologist and started on Xarelto same day.

Patient reported severe headache on 2/12/21 at approximately 3:30 pm followed by vertigo, nausea, vomiting. Patient became unconscious and EMS was called, found patient on floor and she was brought to ED where CT revealed intracranial hemorrhage. Patient was admitted and supportive care given. She had worsening status on 2/17/21 with pupillary reflexes no longer present and withdrawal of care was performed on 2/21/21. Patient expired on 2/22/21.

felt symptoms similar to pneumonia; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (Pfizer Covid-19 Vaccine, Lot number was not reported), intramuscularly on 04Apr2021 at age of 48-year-old at single dose for covid-19 immunisation. The patient previously received first dose of BNT162B2 at single dose for covid-19 immunisation and felt itchy and experienced a skin rash. The patient's concomitant medications were not reported. On an unspecified date, after the second dose, the patient felt symptoms similar to pneumonia for one day. The outcome of event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377012

However, the day after my injection I had light bleeding for 5 days which required light tampons to control; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8732), via an unspecified route of administration, administered in left arm on 27Mar2021 at single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medications included vitamins nos. Patient was not pregnant at the time of vaccination. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient started a light period on Sunday which continued for 5 days. She had a Mirena IUD for almost 7 years (second one inserted 2 years ago). She don't have a period with Mirena; every couple months she will spot for a day but it does not require a tampon. However, the day after her injection she had light bleeding on 28Mar2021 for 5 days which required light tampons to control so it didn't ruin her clothes. Treatment was not received for the event. The outcome of the event was recovered. Event was reported as non-serious.

A week after receiving the shot, I started experiencing severe pain in my left calf. On Friday, April 9, I was diagnosed with 2 blood clots in my left leg (Thrombus in the posterior tibial vein on the left.).

became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; nauseous; light headed; chills; flu like symptoms; arm felt sore/arm at site of injection remains sore; at site of injection remains sore and itchy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (lot number: ER8733) first dose on 30Mar2021 12:30 PM on left arm at single dose for COVID-19 immunisation. Medical history included IDDM (Type 1 diabetes mellitus) and MS (Multiple sclerosis). Patient is not pregnant. No other vaccine in four weeks. No known allergies. Concomitant medications in two weeks included Insulin for IDDM, dimethyl fumarate (TECFIDERA) for MS. Had vaccine at 12:30pm. At 3am (31Mar2021), arm felt sore and felt both nauseous and light headed as well as having chills and flu like symptoms. Went to bathroom and on way back to bed, became faint and passed out onto the floor. Patient hit chin and jaw so hard it was bleeding and obviously very sore and swollen. It's been nearly a week since that incident and arm at site of injection remains sore and itchy. She still feel nauseous at times and her face is still swollen from falling onto the floor and passing out. She was now fearful of having the second dose on 20Apr2021 as due since her reaction to 1st dose was so severe. The outcome of the events was recovering. No treatment for the events. No Covid tested post vaccination.

I felt numbness/tingling in right hand and right foot upon wakening (5:00 AM) on 4/19/2021. I further developed numbness on right side of face around 8:00 AM on 4/20/2021. I went to ER and was admitted to hospital on 4/20/2021. Tests confirmed TIA. Discharged from hospital on 4/21/2021. Numbness persists. Prescribed aspirin, Plavix, and Lipitor while in hospital and upon discharge. Will follow up with family doctor and neurology in next few weeks. Item #21 won't allow me to enter the number of days hospitalized or the hospital name so I will enter it here: I was hospitalized from 4/20/2021 - 4/21/2021 (two days) at Hospital.

Pt. came in for her 2nd shot on 4/22. She informed staff she received the 1st vaccine on 3/26 and developed a DVT on her right leg. She is now on Xarelto as a blood thinner. Her physician stated she could still receive the second dose. Her MRN number is 3934866.

Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic shock; discomfort throat; her heart rate accelerated; flushed face; unsteady; pain; This spontaneous report from contactable consumer (patient) via a Pfizer-sponsored program. A 48-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EJ6202), first dose via an unspecified route of administration, administered in left arm on 28Feb2021 10:40 (at the age of 48-year-old) as SINGLE DOSE for covid-19 immunization. Patient was 48 years old at the time of vaccination. Medical history included partial thyroid removal allergies to iodine, shellfish and bees, she also stated that she saw an endocrinologist who put on thyroid regimen of two different medications and she had a reaction, hives and that regimen had to be discontinued. No Prior Vaccinations within 4 weeks. Concomitant medications included levothyroxine sodium (SYNTHROID) 0.1mg tablet orally once per day in the morning been taking for at least four-fives years and epinephrine (EPIPEN). On 28Feb2021 the patient had small reaction, minor anaphylactic shock, discomfort throat, her heart rate accelerated, flushed face, pain and the patient was unsteady. The patient also stated that her throat got tight Epi Pen was not administered. Clinical course of the events includes, the patient stated that, after she received the vaccine she was instructed to stay 30 minutes instead of the 15 because she was sensitive to stuff and within about 5 minutes she started feeling discomfort in her throat. and was given Benadryl, when she has anaphylactic reactions her body goes in shock. By an hour later the heart acceleration, flush, and feeling unsteady these were completely gone. Benadryl knocked her out and she went to sleep for like 4 hours, woke up and her body was just hurting, but that only lasted a couple of days. She experienced pain for two days after. Had went for 2nd dose and facility denied her due to last reaction. Has been over 3 weeks and wants to know if there is an alternative for 2nd dose of vaccine. The patient underwent lab tests and procedures which included blood cholesterol: off, heart rate: accelerated, thyroid function test: off, all on unspecified date. Outcome of the events discomfort throat, body was just hurting was recovered. Outcome of rest of the events throat anaphylaxis, flushed face got tight, heart rate increased, unsteadiness, cholesterol low, thyroid hormones decreased was unknown.

Anaphylaxis. Patient with a h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling, lightheadedness, hoarse voice, cough, and shortness of breath that began minutes after the 1st Pfizer vaccine dose, lot EN6208. Patient was seen in ED on 3/17 and treated with prednisone and Pepcid. Patient had a return of symptoms of throat closing and shortness of breath and self-medicated with epiPen at home and was then seen by PCP on 3/18. Restarted Singulair and added Pepcid. Patient came back to ED on 3/19 with continued symptoms. On 3/19 ED visit, patient was given Benadryl, Pepcid, Solu-medrol, epinephrine IM, and albuterol inhalation. Patient was admitted to ICU for observation. Continued Benadryl, Pepcid, and Solu-medrol scheduled doses. In ICU x 48 hours without further escalation in care. No lip swelling, stridor or wheezes noted. Urticarial rash has improved. Discharged home on tapered prednisone and Pepcid.

I felt numbness on right side of face; TIA (mini stroke); I felt numbness/tingling in right hand and right foot; I felt numbness/tingling in right hand and right foot; This is a spontaneous report from a contactable consumer patient. This 48-years-old no pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 08:30 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation.Age at vaccination:48 years.Facility type vaccine: Hospital.No other vaccine in four weeks. Medical history included hypertension , well controlled . Concomitant medication(s) included amlodipine taken for an unspecified indication, start and stop date were not reported; vitamin b complex (VITAMIN B COMPLEX) taken for an unspecified indication, start and stop date were not reported and multivitamin. The patient stated "I felt numbness/tingling in right hand and right foot when I woke up at 5:00 am on 19Apr2021. On 20Apr2021 around 8:00 AM I felt numbness on right side of face. On 20Apr2021, I went to ER, was admitted to hospital, was diagnosed with TIA (mini stroke). I was discharged on 21Apr2021. I was given aspirin, Plavix, and Lipitor which I will take for the next three weeks and will follow up with family doctor and neurologist. I still have the numbness". The patient was hospitalized for the events for 2 days. Treatment received for the events (hospitalized 2 days, tests, prescription drugs). No COVID prior vaccination. The patient had COVID tested post vaccination (Covid test type post vaccination= Nasal Swab). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Apr2021.Outcome of the events was recovering.

Developed a blood clot in peroneal vein of left leg.; This is a spontaneous report from a contactable consumer. A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8732), via an unspecified route of administration, administered on the right arm, at the age of 48 years, on Mar2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included drug hypersensitivity to Penicillin from an unknown date and unknown if ongoing. Concomitant medications included vitamin b complex (VITAMIN B); astragalus mongholicus (ASTRAGALUS 6000); lysine (LYSINE) and multivitamins; all taken for an unspecified indication, start and stop date were not reported. The patient developed a blood clot in peroneal vein of left leg on 02Apr2021 06:00. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07Apr2021. Therapeutic measures (blood thinners) were taken as a result of developed a blood clot in peroneal vein of left leg. The outcome of the event was recovered with sequelae.

Extremely heavy period. Haven?t had one in 18 months due to pregnancy and breastfeeding. This is my 4th child and I never have a period while breastfeeding. This period was non stop bleeding for more than 24 hours. Bright red which is unusual because it shouldn?t be fresh blood since it?s been 18 months. Happened almost 2 weeks after second shot. I also had a lot of post vaccine symptoms after second shot which include fever, chills, aches and breathing issues. Those lasted a week. Tested for coronavirus during that timeframe and was negative. Still bleeding, on 3rd day, still bright red but not gushing like it was.

Pfizer BioNTech-Covid-19 vaccine EUA--4/10/2021 started having abdominal pain radiating to back, left chest pain and it progressively got worse. 4/13/21 called PCP to make appointment for 4/14/21, ended up going to ER on 4/14/21 they did EKG, blood work ultrasound of abdomen, X-ray and CT scan. They discovered the clot in portal vein to the liver. ER prescribed blood thinners, states she went back on the 15th because pain was not improving. She saw Dr., hematology, on 4/19/21 she thinks the clot is from the COVID vaccine.

took 2 generic Whole Foods 365 brand Acetaminophen Expiration Date: Jun2020 in Apr2021; ear crystals; Nausea; she wanted to make sure her not feeling well was normal; She had a really bad headache. Clarifying the headache started 1-2 hours after she got the first COVID-19 Vaccine shot; her (left) arm was really sore after she had the COVID-19 Vaccine, but she had expected that; She was still achy in her muscles, but not everywhere. She said her muscles ached from her shoulders up only.; she had a scratchy (sore) throat; she felt tired; she had a little bit of congestion; after she received the COVID-19 Vaccine that she had some clotting, and menstrual irregularities; she had a swollen lymph node in her left arm pit for the last couple days; after she received the COVID-19 Vaccine that she had some clotting, and menstrual irregularities; she had a pressure inside of her head/Her head doesn't feel well. She said she does not quite have a headache, but her head does not feel normal.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0170), dose 1 single dose via an unspecified route of administration in the left arm on 16Apr2021 between 3:53 PM-3:55 PM (at the age of 48 years-old) for COVID-19 vaccination. Medical history included hypermobility syndrome from an unknown date and unknown if ongoing, tends to get headaches with her hypermobility issues, and those headaches felt like pain in her head. Reported she was on the hypermobility spectrum with tension headaches, vertigo positional from an unknown date and unknown if ongoing, 3-4 weeks prior to getting the COVID-19 Vaccine, she tried to take a half of a beta blocker pill to treat the benign paroxysmal positional vertigo (BPPV). She said the BPPV had cleared, and she felt better, vestibular migraine from an unknown date and unknown if ongoing had some residual dizziness from the vestibular migraines, Ehlers-Danlos syndrome from an unknown date and unknown if ongoing. She said she did not have a technical diagnosis for Ehlers-Danlos Syndrome (hypermobility) yet, and finally sees a geneticist next month. She said she was on the weaker end of the Ehlers-Danlos hypermobility spectrum disorder, and did not have a definitive diagnosis. She didn't drink alcohol, exercised every day and slept enough. The patient did not receive any previous immunization with the Pfizer vaccine. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Concomitant medications included cyanocobalamin (VITAMIN B-12) taken for an unspecified indication, start and stop date were not reported and ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. Cyanocobalamin and ergocalciferol were discontinued a week before she got the COVID-19 vaccine to avoid any issues.The patient experienced she had a little bit of congestion on Apr2021, she wanted to make sure her not feeling well was normal on 16Apr2021, she had a really bad headache, clarifying the headache started 1-2 hours after she got the first covid-19 vaccine shot on 16Apr2021, her (left) arm was really sore after she had the covid-19 vaccine, but she had expected that on 16Apr2021, she had a swollen lymph node in her left arm pit for the last couple days on Apr2021, after she received the covid-19 vaccine that she had some clotting, and menstrual irregularities on Apr2021, she had a pressure inside of her head/her head doesn't feel well, she said she does not quite have a headache, but her head does not feel normal on Apr2021, she was still achy in her muscles, but not everywhere. she said her muscles ached from her shoulders up onlyon 16Apr2021, she felt off/felt a little run down on Apr2021, she had a scratchy (sore) throat on Apr2021, she felt tired on Apr2021, nausea on 16Apr2021, her (left) arm was really sore on an unspecified date and swollen lymph node in her left arm pit on an unspecified date. She said it was not possible that her head pressure, and her head feeling off had anything to do with the BPPV or the vestibular migraines. She said her ear crystals had fell out since then, and what she was experiencing now must be due to the COVID-19 Vaccine. She had no fever. She only had nausea for the first 24 hours after getting the COVID-19 Vaccine. She said she had no vomiting. She said her headache had been constant since she had the COVID-19 Vaccine on 16Apr2021. The headache started 1-2 hours after she got the first COVID-19 Vaccine shot. The events did not require an emergency room or physician's office visit. The patient underwent lab tests and procedures which included blood test and urine analysis on an unknown date in Mar2021 or Apr2021: came back normal . Therapeutic measures were taken as a result of she had a really bad headache. clarifying the headache started 1-2 hours after she got the first covid-19 vaccine shot (headache). She took 2 generic Whole Foods 365 brand Acetaminophen 500mg (1000mg total): NDC Number: 42681-7076-1, Lot Number: 8HE1354B, & Expiration Date: Jun2020 in Apr2021. The events did not require an emergency room or physician's office visit. The clinical outcome of not feeling well, headache, arm was really sore, swollen lymph node, had some clotting and menstrual irregularities was recovering and not recovered for pressure inside of her head, felt off, scratchy (sore) throat , congestion, felt tired, hadn't felt 110%, recovered for nausea and unknown for achy in her muscles and ear crystals.

high heart rate; high blood pressure; shortness of breath; bilateral pulmonary emboli; This is a spontaneous report from the patient. This 49-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in the right arm on 04Feb2021 at 08:30 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient's known allergies included morphine, hydromorphone (DILAUDID), sulfas, and coconut. The patient did not have COVID prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269) via unspecified route in the right arm on 14Jan2021 as a single dose for COVID-19 immunization. Concomitant medications were not reported. On 19Apr2021, the patient was having high heart rate, high blood pressure and shortness of breath. She was hospitalized and diagnosed with bilateral pulmonary emboli. The events resulted in emergency room/department or urgent care and hospitalization for 3 days. The patient stated that she doubts this was vaccine related but wanted to report it. The patient was treated with intravenous heparin, then oral rivaroxaban (XARELTO). The clinical outcome of the events high heart rate, high blood pressure and shortness of breath, and bilateral pulmonary emboli was recovering. The patient was tested for COVID post vaccination via nasal swab on 19Apr2021 with result of negative. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of reported events 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 Investigators, as appropriate.

Severe anaphylaxis- Red on face and arm (hives/itching), severe shortness of breath, and severe swelling of face and under the arms.

swelling behind the knees and swelling of the veins; it had to do with blood clot warnings / it was some kind of clotting because of the position of the areas of swelling.; she got like three balls on the right arm; pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm; the lymph nodes in left armpit got swollen; swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow; This is a spontaneous report received from a contactable consumer. A 48-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:30 (Batch/Lot Number: ER8729) as SINGLE DOSE for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. The patient's concomitant medications were not reported. The patient experienced it had to do with blood clot warnings / it was some kind of clotting because of the position of the areas of swelling on 15Apr2021, swelling behind the knees and swelling of the veins, swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow on 12Apr2021, the lymph nodes in left armpit got swollen on 13Apr2021, pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm on 14Apr2021, she got like three balls on the right arm on 15Apr2021. The patient underwent lab tests and procedures which included ultrasound scan: unknown results.She was calling because she got her shot on 12Apr2021 and then she ended up having swelling behind her knee, then she had swelling under her armpit and swelling on her right arm below her elbow. She stated that they weren't lymph nodes, and she went to the ER (EmergencyRoom) had to check and see if they were blood clots. She stated that it turns out that her veins were swollen underneath her arm. She said that was what happened after the shot and that was her first shot. She states so that's her report on what happened. She stated she got the shot in the morning so her symptoms at 6 or 7 pm that evening. She stated she went to the doctor first and then went to the hospital. She went to the doctor on the 16Apr2021 and the hospital on 16Apr2021. She stated that the swelling behind her knee went away on 20Apr2021.Tuesday, 13Apr2021 the lymph nodes in left armpit got swollen. On Wednesday, 14Apr2021, there was a pain in her left arm from the armpit to the elbow, it was a line of pain going down the arm. On Thursday, 15Apr2021 she states she got like three balls on the right arm, on her elbow on the right side. She went to the doctor on Friday 16Apr2021 she went to the ER (emergency room) because they couldn't figure out if it was some kind of clotting because of the position of the areas of swelling. She got an ultrasounds for them to check her blood flow. She stated that the pain in her left arm was going down but didn't resolve until the 22Apr2021. For the little balls on her arm, the MD (Medicne Doctor) gave her a medication for the swelling of her veins but she forgot the name and she doesn't have the paper with her. She states the balls of fluid went away between the 20Apr2021 and 22Apr2021. Everything starting going away that week.She states it had to do with blood clot warnings, and swelling under her skin had to do with the veins. Outcome of with blood clot warnings was unknown, like three balls on the right arm and pain in her left arm from the armpit to the elbow was recovered, remaining events was recovering.Therapeutic measures were taken as a result of swelling behind the knees and swelling of the veins/ she had swelling under her armpit and swelling on her right arm below her elbow, she got like three balls on the right arm.

I am a 48 year old Female been in Menopause for 3years ( no cycle for 24plus months), 4 days after receiving the vaccine I have now started to have stomach cramps an light bleeding as if I were on my period. I have not had any symptoms of this in three years. After my first shot day 14 i had very tender breasts , That has since subsided and now i am dealing with bleeding. would love to know how many other women are going thru this

Got my second Pfizer Covid shot Friday, by Monday I had a huge blood clot in my neck and also a huge one in my left arm. I am now permanently on a blood thinner because of this.

felling sick; fever; malaise; extreme nausea; throbbing of her arms and legs; dizziness; she started hemorrhaging female wise; she started hemorrhaging female wise; This is a spontaneous report from a contactable consumer, the patient, and other contactable consumers. A 48-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Er8735), via an unspecified route of administration in the left arm on 27Apr2021 at 12:45 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 in Dec2020 and was sick for 4 months, neutropenia, allergy to latex; until the virus in Dec2020, the patient would hemorrhage no less than 3 weeks and spotted always for 4 months since COVID-19. Concomitant medications included paracetamol (TYLENOL), ibuprofen (ADVIL 12 HOUR) and ethinylestradiol/levonorgestrel (PORTIA 21). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: Er8732) on 31Mar2021 at 10:00 (at the age of 48-years-old) in the left arm for COVID-19 immunization and felt a little yucky. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient previously took ciprofloxacin (CIPRO) and venlafaxine hydrochloride (EFFEXOR) and experienced allergies. On 29Apr2021 at 10:00 (also reported as 48 hours after the 2nd vaccination), the patient started gushing hemorrhaging female-wise. She described this as bleeding through her pads. Within a week in May2021, (also reported as a few days later), the patient experienced malaise, extreme nausea, throbbing of her arms and legs, and dizziness laying down. She said she felt really bad. She said she was rushed to the emergency room on 03May2021, and then again on 06May2021. The patient also reported feeling sick with fevers as of 04May2021 (also reported that she doesn't know when it started or ended) after the hospital, she was not able to make sense now. The patient was hospitalized for 3 days as of 06May2021 and was considering going back as she was feeling worse. At the hospital, the patient received fluids and antibiotics. The patient was treated with a supplement to slow the blood flow. She did not know if it was improving, persistent or worsening. For 3 days she could not take the supplement but started to bleed more yesterday (probably because she didn't take the supplement). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of "she started hemorrhaging female wise", malaise, extreme nausea, throbbing of her arms and legs, dizziness, feeling sick and fever was not resolved.

headache; fatigue; dyspnea; chest pain; RV infarction; a large amount of clot in the RCA; This is a spontaneous report from a contactable physician. A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05May2021 as single dose for COVID-19 immunization. Medical history included chronic smoker 2 packs per day. Patient was not pregnant at the time of vaccination. Concomitant medications within 2 weeks of vaccination included paracetamol (TYLENOL) and ibuprofen. Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) as single dose for COVID-19 immunization. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Patient developed headache, fatigue, dyspnea, and chest pain for 3 days. She was admitted to hospital on 08May2021 with a completed right ventricular (RV) infarction. Angio in May2021 showed clean coronaries with the exception of a large amount of clot in the right coronary artery(RCA). Given correlation to vaccine administration, unclear if this was related (as reported). Device Date: 11May2021 (as reported). The adverse events resulted in emergency room/department or urgent care. The events were assessed as serious, hospitalization and life-threatening. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events at the time of last observation was recovering. Information on Lot/Batch number has been requested.; Sender's Comments: As a cautionary measure and considering the drug-event temporal relationship of three days, the company cannot completely exclude a causal association between the administration of the PFIZER-BIONTECH COVID-19 VACCINE BNT162B2 and the onset of all the reported events. Medical history of chronic smoker (2 packs per day) cannot be also excluded as contributing factor and additional information of medical history and concomitant medications concerning possible risk factors for cardiovascular diseases, should be also useful for an overall assessment of the case. 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.

Immediately after first dose of vaccine patient developed worsening fatigue, exertional dyspnea, fever, cough, body aches. These symptoms persistent with profound pleuritic chest pain and limited exercise tolerance from January-May 2021. She just now has started to clinically improve. Work-up with small pleural and pericardial effusion. Extensive evaluation without alternative cause for symptoms.

Severe eczema and rash on both hands, arms, face, neck, and leg., debilitating on hands, swelling, throbbing, puss, intense pain, unable to sleep. Itchy rash out of control. no creams or meds helping. eventually went to doctor and received 6 prescriptions and a shot. Very long slow process to recovery, still not fully recovered. Intense itching, bleeding, swelling, unable to hold coffee cup. Rash over large areas of the body.

huge blood clot in her neck and a huge one in her left arm; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow; her arm had swollen up at the elbow and was red, painful and warm to the touch; her arm had swollen up at the elbow; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 07May2021 (received at 48-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included fibromyalgia, colon cancer/postchemo from 2018, APS (antiphospholipid syndrome), arthritis and allergy to sulfa drugs. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. She was not pregnant. Concomitant medication(s) included pregabalin (LYRICA) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; oxybutynin (OXYBUTYNIN) taken for an unspecified indication, start and stop date were not reported; ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VIT B12) taken for an unspecified indication, start and stop date were not reported. Past drug history included known allergies to naproxen and oxycodone. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EW0161), administered in Arm Right on 16Apr2021 12:00 for COVID-19 immunisation. The patient got her second dose of the Pfizer vaccine on Friday, 07May2021. By Monday evening, 10May2021, her arm had swollen up at the elbow and was red, painful and warm to the touch. After appointment she had on Tuesday, 11May2021, she went to the ER (emergency room) as it had gotten worse and confirmed she has a huge blood clot in her neck and a huge one in her left arm. She was put on permanent blood thinners after following up with my PCP (primary care physician). The adverse events 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). As corrective treatment, the patient received Lovenox, Wafarin, Zarelto. Outcome of the events was recovered with sequelae on an unspecified date in May2021. The adverse events were assessed as life-threatening.

On 5/20 patient started experiencing right arm and leg weakness, accompanied by right sided facial numbness and facial droop. She was taken to the ER and admitted to the hospital for right sided hemiplegia and left sided frontal lobe stroke per MRI. No signs of atrial fibrillation. Hospital notes indicate that etiology of stroke is unclear.

Fever wiped me out; Fatigue for a few weeks; Stroke like headpain; Rapid heart rate; Felt like having stroke then heart racing/stroke like headpain; Heart racing; Chills; Pain; Arm felt like it was beaten with a bat; This is a spontaneous report from a contactable consumer(patient), reported in response to Non-HCP letter sent in cross reference to 2 reports. This is second case of two reports. A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injectio), intramuscularly administered in right arm on 26Feb2021 09:00 am (at an age of 48-year-old during vaccination) as 2nd dose, single dose for covid-19 immunisation. The patient medical history included Hashimotos disease from 2000 and ongoing, high blood pressure from unknown date and ongoing, breast cancer from 2015 underwent lumpectomy on Dec2015, ovarian cyst from 2020 and ongoing, Afib (atrial fibrillation) from Apr2019 to an unknown date, atrial fibrillation event due to too much thyroid medication and heart had extra beat benign. The patient's family history included methylation issues, cardiac issues, cancer, higher BP, medication don't work like they should on many family members. Concomitant medication(s) included levothyroxine sodium (TIROSINT) taken for Hashimotos disease from an unspecified start date and ongoing, levothyroxine (LEVOTHYROXINE) oral taken for Hashimoto's disease from an unspecified start date and ongoing, alprazolam (XANAX) taken for anxiety from an unspecified start date and ongoing; mecobalamin (B12 METHYLCOBALAMIN) methylated B-12 taken for methylenetetrahydrofolate reductase deficiency (MTHFR deficiency) from an unspecified start date and ongoing; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), zinc (ZINC); ergocalciferol (VIT D); calcium, magnesium (CALCIUM MAGNESIUM [CALCIUM;MAGNESIUM]); calcium levomefolate (METHYL FOLATE). The patient previously received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported), intramuscularly administered in right arm on 28Jan2021 13:30 as 1st dose, single dose for covid-19 immunisation. The vaccination facility was reported as high school for 1st dose and public health clinic for 2nd dose. The patient had not taken any other vaccine 4 weeks prior to Covid-19 vaccination. On 31Jan2021, the patient underwent lab test and procedures which include blood work: unknown result, did not show heart attack or blood clot, apple watch as abnormal, heart rate was 144 at rest and x-ray as normal. The patient stated that she had ER trip after vaccination. Doctor though she had an embolism and wanted to do a CT. Because of her breast cancer she wanted to avoid heavy radiation and instead she did her x-ray and blood work. On 31Jan2021, the patient experienced two cardiac events. Heart racing was major, so she went to emergency response center. Her oxygen was 90, her heart rate was 144 at rest. Second time lasted a few minutes. On the same day (31Jan201), the patient stated that both events wake her from sleep and took her breath away and also felt that dermal filling around mouth felt numb right after 1st vaccine around 20 min after which lasted a while ago. On unknown date in Feb2021, the patient experienced stroke like headpain, felt like having stroke then heart racing, fever wiped her out, rapid heart rate, chills, pain, fatigue for a few weeks. She also experienced arm felt it was beaten with a bat. These events were presented for nighttime for 2 days. The seriousness of the events considered as disability and the event arm felt like it was beaten with a bat was assessed as non-serious. Therapeutic measures such as heated blanket was taken to chills and fever. The patient took treatment medication such Tylenol, Xanax to slow heart rate and electrolytes for the resulted events. The outcome of the events was recovered for all events in Feb2021 and unknown for the event arm felt like it was beaten with a bat.

Pt developed SOB on the same day of receiving vaccine and she was admitted to the hospital for Pulmonary embolism, elevated troponin, AKI

After three years of menopause, the month after the vaccine I experience several PMS symptoms, including very swollen and tender breasts, body aches, and fatigue. 5 weeks after the shot, I am bleeding as if menstrating.

severe cramping, the next day-fever, the following day-rash, vomiting & diarrhea, fatigue, vaginal bleeding, chest pain.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Patient was transported to Emergency Department, after 1 dose of epinephrine was given by EMT in store.

Bladder pain went to er(meds given) Superficial blood clot on right thigh(meds given) Calf pain right leg ***Er with bilateral pulmonary embolism ( hospital 3 nights) ***Dvt right leg(on warfarin)

I went to chemo therapy in 2018 for colon cancer after colon resection surgery. During chemo my first port failed and caused a huge blood clot in my neck and left arm. I have had three other events in my life of having blood clots, I did not know getting the vaccine would make me so susceptible for more. I got a huge blood clot in my neck and another one in my left arm after receiving the vaccination, my left arm swelled up huge at the elbow, with pain. Blood clots are not always painful for me, depends on where it?s at. I also have swollen lymph nodes in my armpits from the vaccine, confirmed by my oncologist. I went to the ER for the blood clots and again returned two days later to make sure I did not have PE, however the nodules in my lungs had enlarged and my lymph nodes are swollen. This is well after two weeks after I got the second dose of the vaccine, however, the blood clots take time to get as big as they are, so this probably started after the first injection, perhaps just got worse after the second one. I am now stuck on blood thinners forever because of this vaccine, I will not be getting any more of these shots.

chest pain; shortness of breathe; having difficulty standing; Thought she was having a heart attack; O2 saturation decreased; Another lab (she could not identify) that was high; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 01May2021 (Lot Number: EW0175) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Patient took the first dose in Arm Right on 10Apr2021 (Lot Number: ER8730) for covid-19 immunization, and experienced hand pain, skin tightness, difficulty in standing, pain, heaviness in arm, back pain, walking difficulty. Vaccine Administered at (Name) Facility was No. Medical history included, sickle cell from 01Sep1972 and ongoing, ongoing penicillin allergy since she was a kid, ongoing drug allergy to other medications. The patient's concomitant medications were not reported. Patient stated she got the second shot on 01May2021 and she did not experience the funny feeling and had nothing at the injection site. Sunday was okay. Monday morning around 7am she started having severe chest pain and shortness of breathe and couldn't breathe. It was getting more and more severe. She had an appointment and the Nurse Practitioner said next time don't stay home and go to an ER if you feel all that pain. So on Tuesday she said let me get out of the house and go to the appointment. Someone that understood saw her and thought she didn't look well and ambulance people said she did not look well and they wanted her to go to the ER. She said she would watch it because she had a similar reaction with the first one but it was in her back. They checked her out and said it is the vaccine because she was not having this severity of anything before and they wanted to take her to the ER. They took her information and she said let me watch it and see. She continued to her appointment and it got worse and worse and in the evening after the appointment they had to take her to the ER because she thought she was having a heart attack. At the ER they drew troponin, which was normal, and another lab (she could not identify) that was high and they thought she may have had a blood clot so they did a CT with contrast and it was negative for blood cot, so they ruled out a blood clots in her lungs. Patient reported that while she was out for her errands and appointments, someone was concerned for her on the street because she was very short of breath and having difficulty standing. Patient reported that there was a fire department ambulance parked close by. It reported that the paramedics assisted her into the ambulance and took her pulse ox and blood pressure. The paramedics told her that her O2 sat was low and wanted her to go to the hospital via ambulance. Caller reported that she did not want to have to pay the bill for the ambulance, so she declined transport to the emergency room. Caller reported that she want to another appointment. Caller reported that the pain was there and was severe, but she pushed through with the thought in the back of her head that the chest pain would not continue. Caller reported that she kept hanging on to the thought that maybe the chest pain will last the same amount as her back following the first dose of the Covid-19 vaccine. Caller reported that around 4:00 PM or 5:00 PM on 03May2021, the chest pain was not going away and she was concerned for her heart. Caller reported that she was taken over to the emergency room. Caller reported that while she was in the emergency room, she was trying to tell the staff that she had gotten the Covid-19 vaccine. Caller reported that the emergency room staff was more concerned about doing things and wanted to give her aspirin. Caller reported that she refused the aspirin and told the emergency room staff to do lab tests first. Caller reported that her troponin came back and the emergency room staff said that her heart was ok at that time. Caller reported that she was still short of breath and her O2 sat was very low while she was in the emergency room on 03May2021. Caller reported that another lab test was very high. Caller reported that she was not kept overnight in the emergency room. Caller reported that she came home after leaving the emergency room and the chest pain was there during the night on 03May2021. Caller reported that on 04May2021 around midday, the chest pain started subsiding but she was still sore breathing in and out. Caller reported that by Thursday, 06May2021, there was just soreness in her chest and by Friday, 06May2021, she was fine and back to baseline. Caller reported that the emergency room physician informed her that her side effects may be something to do with the Covid-19 vaccine. Caller reported that it has to be the Covid-19 vaccine that caused her side effects. Event chest pain required a visit to Emergency Room, no event required a visit to Physician Office. The outcome of events were reported as recovered on 07May2021.

April 14, 2021 Seen at emergency room symptoms of pericardial effusion however were mild and no echocardiogram performed to confirm, but now believe this was occurring although resolved on own. June 2, 2021 Admitted to ICU for Cardiac Tamponade and Pleural Effusion. Remained at ICU for 3 days after procedures to remove effusion and tamponade June 11, 2021 Seen at emergency room for repeat symptoms of pericardial and pleural effusion. Mild pericardial effusion confirmed - rest at home June 14, 2021 Taken to ER for increased pericardial effusion and pleural effusion. Remained in hospital through June 19, 2021 for testing and treatment

On June 11th I began having pain in my left calve. June 18th I went to the doctor. I had an ultrasound and a bloot clot was found. I have developed a blood clot in my left calve.

Severe chest pain, shortness of breath, severe headache & fever. Went to an Emergency room on June 1st and was diagnosed with Pericarditis. Was released the same day and given IBprofen & Colchicine as an antiinflammatory for the fluid buildup around the heart. The pain continued despite medication returned to ER on June 3rd, 2021. Was hospitalized through June 8th. Was released. Symptoms and pain continued after release. Revisited ER on June 10th, 2021. At this point, ER doctor reevaluated all symptoms and after further consultation determined the immune system was causing adverse symptoms due to the Covid vaccine and started new treatment to suppress the immune system. This proved to help with pain and symptoms.

massive pulmonary embolism; This is a spontaneous report received from a contactable physician. A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Mar2021 (at age of 48 years old) (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included asthma and menorrhagia. No past drug. Concomitant medication(s) the patient received within 2 weeks of vaccination included ethinylestradiol, norgestimate (SPRINTEC) taken for an unspecified indication, start and stop date were not reported. The patient experienced massive pulmonary embolism on 10Apr2021 with outcome of recovering. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was hospitalized for massive pulmonary embolism for 30 days. catheter-directed thrombolysis received for event. The patient was not diagnosed with COVID-19 prior to vaccination, and Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of pulmonary embolism due to temporal relationship. However, the concomitant medication of ethinylestradiol, norgestimate may have contributed to the development of the PE. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including VQ scan, pulmonary angiogram results and coagulation panel, 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 started bleeding heavily from my uterus, I had a uterine ablation 5 years ago till that day. I ended out bleeding out and coding. They revived me and I need 2 blood transfusions.

I was diagnosed and hospitalized with ITP - Idiopathic thrombocytopenic purpura or Immune thrombocytopenic purpura. I have never had this before and have always been in good health.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 10:00 am at age of 48-year-old (Batch/Lot Number: EN6207) at single dose for COVID-19 immunisation. Medical history included known allergies to sulfa drugs, diagnosed with COVID-19 prior vaccination. The patient is not pregnant. Concomitant medications within 2 weeks of vaccination included magnesium sulfate; montelukast sodium (SINGULAIR); fluticasone propionate (FLONASE); cetirizine hydrochloride (ZYRTEC); omeprazole. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 on 25Feb2021 10:00 am at age of 48-year-old administered in arm left (Batch/lot number EN6202) at single dose for COVID-19 immunisation. The patient experienced ITP (idiopathic thrombocytopenic purpura or immune thrombocytopenic purpura) on 09May2021 22:00. The patient was diagnosed and hospitalized with ITP in 2021 for 7 days. The patient had never had this before and have always been in good health. The event was serious for hospitalization, life threatening. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment for the adverse event which included 5 bags of platelets, 5 IVIG (intravenous immunoglobulin) infusions, eltrombopag olamine (PROMACTA), P. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not resolved.

48 y/o female with past medical history significant for alcohol abuse and smoking presented to the emergency department on 6/27/21 after a fall with large contusion and petechial rash noted. Labs significant for severe thrombocytopenia (PLT 8), mild leukopenia (WBC 4.1), and recurrent transaminitis (AST 557, ALT 975). Of note, patient had been diagnosed with idiopathic transaminitis in October 2020. Patient reports taking multivitamin daily. Babesia and anaplasma screens were negative on 6/28/21. Hematology/oncology consult felt that thrombocytopenia was likely related to receipt of Pfizer Covid-19 vaccine on 6/8/21 (administered at pharmacy). Patient received platelet transfusions, IVIG 1 g/kg daily x 2 doses on 6/29/21 and 6/30/21, prednisone 60 mg PO daily x 2 doses on 6/27/21 and 6/28/21, and dexamethasone 40 mg PO daily x 4 doses 6/29/21 - 7/2/21. Patient was told to avoid vaccination with second dose. Pfizer Covid-19 vaccine recorded as allergy in patient's chart. As of 7/1/21, platelet count had risen to 82.

My biggest complaint is that I am now 66 days out from the first shot and no period. I did get sick from both the first and second shot (sore arm, fevers, fatigue, unable to function - especially on the second shot). But I should have had a period between the 1st and the 2nd - and there was nothing. I finally had some spotting last week. But still literally nothing. This is really frustrating and frankly scary.

48 y/o female with pmh of HTN, HLD, DM2 and bipolar disorder, transferred to ICU from the psychiatric until after cardiac arrest. The patient was originally admitted on 5/22 for evaluation of bizarre behavior. She was noted to have flight of ideas, emotional instability and multiple attempts to leave the room naked. She was admitted to the floor there with behavioral health consulted for evaluation. She was then transferred to another unit on 5/27/21 for additional management, with a plan for a 90 day inpatient hold. While in the unit she was managed with a medication regimen including Thorazine, Lithium and Abilify. Medicine was consulted for management of hypertension, and Ob-Gyn was following for abnormal vaginal bleeding with work-up unable to be completed due to her mental status. ECT treatments were also started this week on 6/23, with the patient receiving her second ECT treatment this afternoon. From review of the pre-procedure note, the planned induction was with etomidate, succinylcholine, glycopyrrolate, and Brevitol (methohexital, barbiturate class); the actual MAR is not up to date with her procedural medications at the time of admission. Post treatment, the patient was noted to be conversive and in her normal state of health. This evening, nursing staff heard a loud noise from the patient's room around 1630. Upon arrival, they found her down, unresponsive and without a pulse. An ACT was called and CPR was initiated for a duration of approximately 30 minutes. Reportedly the AED display showed asystole, followed by PEA. She received a reported five rounds of epinephrine, one dose of bicarbonate, and one dose of calcium during the event. The patient was intubated during the code with a large amount of gastric contents present, concerning for aspiration. A right ankle IO was placed due to significant difficulty securing access elsewhere. ROSC was obtained with a junctional rhythm, and the patient was transferred for further management. On arrival the patient is non-responsive without any sedation running. She became hypotensive by arrival to the ICU requiring norepinephrine. On later inspection of her IO, there was suspicion for infiltration of fluids and medications around her right ankle. She has had significant secretions into her ETT since transfer. HPI as noted above. ICU course notable for hypoxic respiratory failure with ARDS likely from lung injury from cardiac arrest. She subsequently developed shock and required vasopressors. Initially the patient was noted to have brainstem reflexes, however on 6/25 the patient had an exam change with no spontaneous breaths and pupils fixed and dilated. The initial head CT following arrest was performed which showed diffuse cerebral edema with effacement of the sulci and gray and white matter differentiation consistent with severe anoxic brain injury. There was diminished ventricular size with complete effacement of the fourth ventricle and tonsillar herniation from mass effect. Neurology was consulted. The patient remained on vasopressor and mechanical ventilator support. A NM scan was performed to evaluate cerebral blood flow showed absence of effective cerebral perfusion. Neurology performed an exam and the patient was pronounced deceased at 1802 on 6/27/21 a doctor. The family was informed of the results. After discussion with family, the patient was removed from mechanical ventilator support and vasoactive medications discontinued with the family at beside.

Her body produces mucous/blowing her nose; She had a horrible cough she couldn't get out; her blood clot was already high; lose her voice; She had chills; rattle in her chest; She was cold ,and it was hot (88 degrees); She was sweating, and was warm all over her body.; She was sweating, and was warm all over her body.; Her throat seemed sore after.; She had dry cough. It felt dry; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0183, NDC number and Expiry date: Unknown), via an unspecified route of administration, administered in left arm on 01Jun2021 (at the age of 48-years-old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing high WBC/white blood cell count increased and anaemic. Patient was overweight. Patient said that before the shot, she as been exposed to COVID-19 and never caught the virus. She has taken a COVID-19 test and it was negative two days ago and does not have COVID. Concomitant medication(s) included fenofibrate taken for blood cholesterol, colecalciferol (VITAMIN D 2000), iron, losartan and hydrochlorothiazide taken for blood pressure, from an unspecified start date and ongoing. It was reported that, two days after getting vaccinated, the patient got sick, and she feels like she has pneumonia. She was overweight. On an unspecified date in Jun2021, her body produces mucous/blowing her nose, and she had chills on 03Jun2021. Patient said that it all started a little after the shot. She felt like she had sand in her throat and she woke up feeling bad. She had a horrible cough on an unspecified date she could not get out. She still has a rattling in her chest. She wants to know if it is possible for this to stay in her chest and form a blood clot. Patient said that after vaccination, she had her nephew graduation, and she screamed at it. Then her throat seemed sore after and she would lose her voice, but it would come back. Her throat started hurting. As the days went on, she felt like there was dust in her throat. She had dry cough and it felt dry. It was like more dust had collected in her throat. Patient felt real sick, but she never had a fever. She was cold and it was hot (88 degrees) in and was sweating and was warm all over her body. Patient has a higher than normal WBC/ and that was one of her main concerns about getting the vaccine. Since her blood clot was already high and she was scared it would put her WBC in maximum overdrive. There was no investigation assessment. The patient underwent lab tests and procedures which included coagulation test: high on unspecified date in 2021 her blood clot was already high, SARS-CoV-2 test: Negative on 30May2021 and white blood cell count: high on unspecified date in 2021 (high white blood cell count). Patient wanted to know if there is any chance of getting pneumonia with the vaccine for which patient received response as "a review of the Prescribing Information for Pfizer COVID-19 vaccine failed to find any information regarding pneumonia being an adverse event with the vaccine". Patient was wondering if Pfizer is getting reports of side effects being full on pneumonia like symptoms that last. Patient asked if there was any chance that of blood clots after vaccination, and would like to know if anemic people who had the vaccine had adverse events and if there had been reports of cytokine storm and received response which says, failed to find any information regarding cytokine storm being an adverse event with the vaccine and was asked patient to consult with her doctor or health care provider for further guidance. The outcome of the events rattle in her chest, her throat seemed sore after, she had dry cough and her blood clot was already high was not recovered, and the outcome of chills, she got sick, her body produces mucous/blowing her nose, she had a horrible cough she couldn't get out, she was cold, and it was hot (88 degrees), she was sweating, and was warm all over her body and lose her voice was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Anaphylaxis immediately following vaccine. Taken to ER from clinic. Released from ER. Two days later on March 19 I was taken back to ER after 2 additional anaphylaxis episodes. I was administered epipen twice in ER on the 19th and was admitted into hospital in the CCU as ICU patient. Released on March 23. Since release from hospital I have had 6 cases of anaphylaxis requiring epipen since the vaccine- each in response to bug bites. I have never used epipen for bug bites prior to vaccine- it was manageable through Benadryl previously. I am now on 200 milligrams of Benadryl per day, 15 milligrams of prednisone. Pepcid AC twice a day. Advair once a day. This is all to keep my system from experiencing anaphylaxis. My allergies are much worse since the vaccine.

Healthy, well controlled blood pressure, active 48 year old woman, avid hiker of summiting elevation, supposedly training to summit Mt. June 2021, was cancelled d/t pulmonary embolism. Been hiking elevations up to 10,000-11,000 feet weekly to 2x/week before May 5, 6, 2021. Then, the final training was to Mt. May 5, 6, 2021. Got stung by a bee with mild erythematous reaction on the dorsal area of the right thumb. Hiked to Mt. but ended, d/t to chest pain, SOB, abdominal pain. Initially thought to be caused by altitude sickness. However, when the hike was over - went home. On May 7, went for a walk and could not walk even just 5 steps without getting SOB. Thought it was post altitude sickness. Went to Urgent care d/t increasing inflammation to the right thumb caused by the bee. Given antibiotic but told the doctor there that I was having chest pain. Immediately, pulmonary embolism workup started starting with EKG. Then, D-dimer. D-dimer showed it was elevated and immediately was advised to be admitted to a hospital. Went to the hospital. CT angio with contrast was performed and showed "MULTIPLE SUBSEGMENTAL FILLING DEFECTS ON ALL " my pulmonary branches except the left lower lobe. All clotting factors and immunoglobulin studies were all negative for clotting problems and allergy to bee venom. Was given lovenox and transitioned to Apixaban. The reason I am reporting this now is because given that I had "subsegmental filling defects " in my pulmonary branches made me think that these clots have been forming for awhile, and NOT acute. The clots were exacerbated by the getting stung by a bee and the altitude. All my medical providers cannot explain the exact science or the mechanism at to what happened. However, it makes sense that this clots have been forming for awhile. I am afraid, it started right after the PFIZER covid vaccine. I would like to deny this event but this makes sense. Going to Mt. tipped me over completely. I ended up cancelling my Mt. hike. (Of note, I am a pediatric nurse practitioner as well).

on July 14th, patient had a massive ischemic stroke; no risk factors. Patient did have COVID infection February 2021

Began having tachycardia on 1/3/21 that continued through the night with pulse 145-180. Went to ER on 1/4/21 and was diagnosed with Atrial Fibrillation with RVR and had to be electrocardioverted. Have since been placed on Cardizem 180mg TID.

Afib 16 hour the day after shot two. Additional testing showed pericarditis and heart enlargement not previously noted

2 months after second shot, I had been taken to the emergency room with subdural hemmorage, stroke, subrachnid hemmorage, leukocytosis, cerebral venous sinus thrombosis. I would like to find out if this is related to the vaccine.

Palpitations, increased blood pressure, wheezing ,SOB within 5 minutes symptoms increase as time went on-tachycardia -epi pen administer after 15-20 mins after injection

Anaphylaxis- needed 3 doses of epinephrine before admission to ER. In ER received IV steroid and famotidine. Was given prescriptions for epipen and oral steroids (60mg x 5 days).

Anaphylactic reaction requiring EpiPen 0.3, Benadryl IM and transport to Emergency Department per EMS.

"I received the Pfizer Covid vaccine Wed afternoon around 4pm. Thursday morning around 9:30 I started with severe pain in my left leg. The pain worsened through the day and my leg began swelling. No other symptoms at all. This morning my leg was twice the size of my right leg so I went to the ER. I live in so I'm at ED. I have a massive blood clot running the the length of my leg - from my thigh to my ankle. I'm very lucky I got here so fast! I?m a very healthy 49 year old with no history of DVT or blood clots so they dug further to find out why. A cat scan showed I have a congenital condition called May Thurner Syndrome. I?m so relieved to have an answer and it?s fixable! The vascular doctors are not 100% convinced that?s not all that was going on as I was born with the syndrome and I?ve gone this long without a clot. So they are doing lots of labs to see if anything else shows up. This is where we are at. I?m being admitted to take care of the clot."

Felt like a restless leg or blood clot but not as severe.; Felt like a restless leg or blood clot but not as severe.; Left below knee pain and discomfort. Some to the right leg as well.; Left below knee pain and discomfort. Some to the right leg as well.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Checked back of leg for warmth or bruising lasted day 2 and day 3.; Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort; This is a spontaneous report from a contactable nurse reporting for herself. A 49-years-old female patient started to receive bnt162b2 (BNT162B2; Lot: ECO142) vaccine , intramuscular in the left arm on 29Dec2020 15:45 at single dose for Covid-19 immunisation . Medical history included hypertension, anaemia, blood cholesterol increased , depression, food allergy (whey casium) (taking doxepin for it with relief). Concomitant medication included doxepin (DOXEPIN), metoprolol (METOPROLOL), calcium ascorbate (VITAMIN C [CALCIUM ASCORBATE]), tocopherol (VITAMIN E [TOCOPHEROL]), cyanocobalamin (VITAMIN B-12) , atorvastatin (ATORVASTATIN), sertraline (SERTRALINE). The patient experienced felt like a restless leg or blood clot but not as severe. on 30Dec2020 07:00 with outcome of recovered , left below knee pain and discomfort. some to the right leg as well. on 30Dec2020 07:00 with outcome of recovered , checked back of leg for warmth or bruising lasted day 2 and day 3. on 30Dec2020 07:00 with outcome of recovered , did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort on 30Dec2020 07:00 with outcome of recovered. The event blood clot was considered serious (Important Medical Event). Course of the events The patient reported left below knee pain and discomfort. Some to the right leg as well. She checked back of leg for warmth or bruising lasted day 2 and day 3. She felt like a restless leg or blood clot but not as severe. She felt better to stand instead of sitting. Did feel some discomfort to left arm as a result of the shot in left arm, tender and could feel when holding arm up some discomfort. No shortness of breath, no nausea, no dizziness, no increased fatigue (baseline - not enough sleep - working 3 jobs).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported leg thrombosis 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.

? Covid-19 Vaccine, Mrna, Bnt162b2, Lnp-S (Pfizer) Anaphylaxis sleepiness, Swelling face and throat, breathing difficulty, cough, aphasia-pt was not able to express her thoughts or needs, pt felt that her heart was beating slow, vomiting started next day and lasted for 4 days, self treatment immediately by pt- Benadryl 50 mg and albuterol inhaler, later Prednisone course by medical professional symptoms completely resolved after 5 days

Patient began having increasing shortness of breath about a week after receiving first dose of Pfizer COVID-19 vaccine. Symptoms worsened and persisted to the point where patient called her PCP on 1/26/2021, who advised her to report to ED if experiencing worsening symptoms and/or low oxygenation. Patient reported to ED on 1/29/2021 due to tachycardia and O2 sats <90%. On presentation, patient was found to have bilateral pulmonary emboli involving the upper and lower lobe regions bilaterally including segmental branches without evidence of right heart strain.

a knot in her arm; sore to the touch; Exhibiting flu-like symptoms; Fever; Severe body aches; Runny nose; Cough; Anaphylaxis; This is a spontaneous report from a contactable consumer(patient). A 49-year-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL3246), intramuscular in right bicep(arm) on 13Jan2021 around 16:15 at single dose for preventative. Medical history included high blood pressure from 2016 and ongoing. Concomitant medication included ongoing chlortalidone for high blood pressure. She received first dose of covid vaccine BNT162B2 (Lot: EL0140) on 23Dec2020 around 13:00., in right bicep(arm), a little above where she received this second dose for covid-19 immunization, she previously received flu shot for immunization and had a knot in her arm where it is tender to the touch and sore. She had an anaphylaxis event directly after her shot on 13Jan2021, she was kind of knocked out for the anaphylaxis event and her body was hurting. She was not sure if it was from the shot or from the trauma anaphylaxis event. She received an epi shot in the clinic, diphenhydramine (BENADRYL)into her arm. She was taken to the ER(Emergency Room) where she stayed till about 9:30pm. She was not admitted. Anaphylaxis recovered on 13Jan2021. She also stated that she got sick after the shot, she was exhibiting flu-like symptoms, she never lost her taste or smell, she had a fever, severe body aches, runny nose, and a cough. These symptoms started the next day on the 14Jan2021 and got worse on the 15Jan2021, on 17Jan2021, She feeling better morning and recovered completely by the time she went to bed in regards to her flu-like symptoms, she felt like herself and normal. She felt rested. This morning she felt good. Treatment included paracetamol (TYLENOL) and she was taking diphenhydramine every night since the anaphylaxis occurred. She still had a knot in her arm that it was very sore to the touch which she stated was pretty common even with flu shot(not know the name of the flu shot or have lot, NDC, or expiration date) where it was tender to the touch and sore. There was no relevant test. Outcome of anaphylaxis was recovered on 13Jan2021, of a knot in her arm, sore to the touch was unknown, of other events was recovered on 17Jan2021.

Lips swelling and face; Lips swelling and face; Anaphalaxis; Anaphalaxis; This is a spontaneous report from a contactable other HCP (patient). A 49-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Eh9899) via an unspecified route of administration on 18Dec2020 18:30 at single dose in left arm for COVID-19 immunisation. She received the second dose (lot number: El1283) in right arm on 08Jan2021. Medical history included Idiopathic anaphylaxis and was allergic to penicillin, had COVID-19 from May2020 to an unknown date. Concomitant medication included unspecified birth control pills. The patient experienced anaphalaxis on 19Dec2020 06:00 AM. She talked with her doctor lips swelling and face. Treatment received for events lips swelling and face. But her question is she had an IGG antibody test and it was negative. She had COVID in May2020 and have been tracking her antibodies. She wanted to know 'does this antibody test show the same antibodies?' She had negative after the two vaccines. The patient is not pregnant. Events outcome 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 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.

Mild Headache and a rash that started on my lip and spread to my cheek, my eye and forehead. The rash it blistery kind of looking, little bit blister and they would open and bleed and then close back up. It was also burning. It start continually spread more. I went yesterday 02/09/2021to a Dermatologist he treated me for a contact kind of dermatitis as if he was unsure if it was linked to vaccine or not. He gave me two steroid injections in the office and prescribed a cream Elidel 1% . The medications seem to be clearing up my face today.

Hives and it progressed to an anaphylactic reaction; Hives and it progressed to an anaphylactic reaction; hives itch; slight swelling around her eyes; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021 at single dose for COVID-19 immunization. Medical history included anaphylaxis (Patient does have a history of anaphylaxis to bee stings), Hysterectomy, Gallbladder surgery, Mastectomy partial/ lumpectomy, Alcohol use: Yes (Comment: socially rare, Drug use: Never), Shellfish-derived products, Seasonal allergies (J30.21), HX: breast cancer (Z85.31), smoker stopped on 01Jan2000 (Former Smoker, Years since quitting: 21, Smokeless tobacco: Never Used), Hot flashes, Axillary Node Dissection. Allergie to Bee venom, Shellfish-derived products, Coconut, Codeine, and Other The patient's allergies have been reviewed. Family History included Cancer oral of Mother; Lung cancer of Father and Maternal Grandfather and Paternal Grandmother; Uterine cancer of Paternal Grandmother. Concomitant medication included ongoing cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ongoing dexmethylphenidate hydrochloride (FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]), epinephrine (EPIPEN), ongoing lisinopril dihydrate (PRINIVIL), lisinopril (ZESTRIL), ongoing metoprolol succinate (TOPROL XL), valaciclovir hydrochloride (VALTREX), zolpidem tartrate (AMBIEN) from 30Apr2020 and ongoing, promethazine (PHENERGAN [PROMETHAZINE]) from 13Sep2019. Patient previously took Codeine and had vomiting and allergy to it. Patient had an anaphylactic reaction to our vaccine. it started as hives and it progressed to an anaphylactic reaction on 08Jan2021. they gave patient Benadryl afterwards for her anaphylactic reaction because they do not want to interfere with the efficacy of the vaccine that she was able to breathe so she did not have to have any Epipen or anything. She was sent to an ER within hospital to get that. She was in the hospital getting the shot and then they sent her to the ER and she started having the reaction. Emergency department summary of care: Chief complaint: Allergic reaction. ED Diagnosis: Diagnosis Final diagnosis. Allergic reaction to vaccine: Allergic reaction to vaccine. ED Vitals: Date/Time: 08Jan2021 14:00. Pulse: 79. Resp.: 18. BP: 144/86. SpO2: 96%. Date/Time: 08Jan2021 12:54. Pulse: 90. Resp.: 16. BP: 147/98. SpO2: 96%. Weight: 72. 06 kg (160 lb). Date/Time: 08Jan2021. Temp.: 97.6 F (36.4 C). Pulse: 121. Resp.: 16. SpO2: 97%. Result: None. Imaging result: None. ECG result: None. Emergency Department Encounter: Patient was placed in face mask in first look and the following protective measures were taken unless additional measures were taken and documented below in the ED course. Patient was wearing facemask when nurse entered the room and throughout our encounter. nurse wore full protective equipment throughout this patient encounter including a face mask, and gloves. Hand hygiene was performed before donning protective equipment and after removal when leaving the room. Date of encounter: 08Jan2021. Last ED provide Note: patient is a 49 y.o. female who presents to the ED c/o chief complaint of allergic reaction. Patient reports that she just received her first Covid immunization approximately 30 minutes ago, immediately broke out into hives. Patient reports she had hives on bilateral arms as well as her back, hives itch. Patient complains of slight swelling around her eyes. No swelling of her tongue slipped or throat, no difficulty swallowing, no difficulty breathing, no nausea or vomiting. Patient reports that prior to the vaccination she was at baseline without complaint. Patient does have a history of anaphylaxis to bee stings, no other history of anaphylactic reactions, does have history of allergic reactions with hives. Patient received 50 mg oral Benadryl prior to arrival. Patient reports that the hives on her arm have since resolved, continues complain of itching on her back. No active ambulatory problem. No resolved ambulatory problem. All systems reviewed and negative except for those discussed in HPI. PHYSICAL EXAM nurse have reviewed the triage vital signs and nursing notes. ED Triage Vitals (08Jan2021 1229): Temp: 97.6 F (36.4 C), Heart Rate: 121, Resp.: 16, SpO2: 97%. General: No acute distress. HENT: NCAT, PERRL, Nares patent, no swelling of the lips tongue, no posterior oropharyngeal swelling, Voice is normal, no difficulty handling secretions Eyes: no scleral icterus. Neck: trachea midline, no ROM limitations, no stridor. CV: regular rhythm, regular rate. Respiratory: normal effort, CTAB, no wheezing rales or rhonchi Abdomen: soft, nondistended, nontender to palpation, no rebound tenderness, no guarding or rigidity. GU: deferred. Musculoskeletal; no deformity. Neuro: alert, moves all extremities, follows commands. Skin: warm, dry, bilateral arms are normal in appearance, no hives, No rash. Patient has several scattered Hives on her back. Lab Results: No results found for this or any previous visit (from the past 24 hour(s)). Nurse ordered the above labs and reviewed the results. Radiology: No Radiology Exams Resulted Within Past 24 Hours. Nurse ordered the above noted radiological studies. Nurse reviewed the images and results. Nurse agree with the radiologist interpretation. Procedures: Medications - No data to display. PROGRESS DATA. A complete history and physical exam have been performed. All available laboratory and imaging results have been reviewed by nurseself prior to disposition. After the initial H&P, Nurse discussed pertinent information from history and physical exam with patient/family. Discussed differential diagnosis. Discussed plan for ED evaluation/work up treatment. All questions answered. Patient/family is agreeable with plan. ED Course: Patient complaining of allergic reaction, hives seems to be resolving, no symptoms consistent with anaphylaxis. Symptoms seem to be improving after oral Benadryl, no further medication at this time, will monitor closely. Patient reassessed, reports rash has resolved, itchiness has resolved. Patient continues to deny any swelling of lips tongue or throat, no difficulty breathing, no nausea or vomiting. Discussed at length with the patient that Nurse do not advise her to get the second dose of the vaccination as it can cause repeat allergic reaction, possibly worse allergic reaction. Discussed possibility of obtaining the mother no vaccine once it becomes available. Patient understands. Discussed need for close follow- up with primary care physician, Extensive discussion return precautions. Discharging. The patient was reexamined. They have had symptomatic improvement during their ED stay. nurse discussed today's findings with the patient, explaining the pertinent positives and negatives from today's visit, and the plan of used plan for discharge as there is care. No emergent indication for admission. Discussed limitation of the ED work-up and that this is to rule out life-threatening emergencies but that they could require further testing as determined by their primary care and or any referred specialist patient is agreeable and understands need for follow-up and repeat exam/testing. Patient is aware that discharge does not mean there is nothing wrong. Indicates no emergency is present, and that they must continue their care with their primary care physician and/or any referred specialist. They were given appropriate follow-up with their primary care physician and/or specialist. nurse had an extensive discussion on the expected clinical course and return precautions. Patient understands to return to the emergency department for continuation, worsening, or new symptoms. Nurse answered any of the patient's questions. Patient was discharged home in a stable condition. As of 14:11 EST Vitals: BP - 144/86, HR -79, Temp - 97.6 OF (36.4 (Tympanic) 02 SATS - 96%. DISPOSITION: DISCHARGE: Patient discharged in stable condition. Reviewed implications of results, diagnosis, meds, responsibility to follow up, warning signs and symptoms of possible worsening, potential complications and reasons to return to ER. Patient/Family voiced understanding of above instructions. Discussed plan for discharge, as there is no emergent indication for admission. Patient referred to primary care provider for BP management due to today' BP. Pt/family is agreeable and understands need for follow up and repeat testing. Pt is aware that discharge does not mean that nothing is wrong but it indicates no emergency is present that requires admission and they must continue care with follow-up as given below or physician of their choice. Schedule an appointment as soon as possible for a visit in 2 days. Medication List NO changes were made to your prescriptions during this visit. ED Treatment Team. Previous ED Visit: None. ED Arrival Information: Arrival: 08Jan2021 12:27 PM. Means of Arrival: Car. Escorted By: Self. Service: Emergency Medicine Acuity: Emergent. Admission Type: Emergency. ED deposition: Discharged: condition stable. Triage sepsis screen: Row name: Sepsis screen. Documented or Suspected Infection: 0. Documented or Suspected Infection. Indications: None. Acutely Altered Mental Status:0. Temp <96.8 OR > 100.9: 0. Heart Rate >90): 0. Respiratory Rate > 20: SBP < 90:0 MAP < 65:0 Blood Glucose >140(mg/dL)- Not diabetic: WBC <4 or>12 (10*3/mmm3: Unknown Bands >10%. Result of current screen is: Negative. Medication administration from 08Jan2021 12:27 to 09Jan2021 02:02: None. ED Prescription: None. Discharge Orders (From admission, onward): None. Allergies (Reviewed on: 08Jan2021) Agent Bee Venom Severity: High, Shellfish-derived Products, Severity: High Comments: Anaphylaxis. Coconut Comments: Facial swelling. Codeine Comments: Vomiting. Other Severity: Phenofibrates cause Skin hives. Immunizations Administered Name: COVID-19 (PFIZER) Tetanus Up TO Date: None. ED LDA Documentation (to) Patient Lines/Drains/Airways Status Active Airway / Central Venous Catheter Line / Drain / Epidural Line / Intraosseous Line / Peripherally Inserted Central Catheter Line / Peripheral Intravenous Line / Arterial Line: None. Weight: 72.6 kg (160 1b). Height: 157.5 cm (62"). Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02. Oxygen Therapy from 07Jan2021 14:02 to 08Jan2021 14:02 (continued) Date and Time 08Jan2021 14:00 (also reported 14: 11) sp02: 96 %. Date and Time 08Jan2021 12:58 Device (Oxygen Therapy: Room air. Date and Time: 08Jan2021 12:54 sp02: 96 % Device (Oxygen Therapy: Room air. Date and Time 08Jan2021 12:29 sp02: 97%. Breathing Date and Time: 08Jan2021 14:00, Date and Time: 08Jan2021, 12:54 Date and Time: 08Jan2021 12:29 were sp02:96 %, sp02:96 % and sp02:99 %. 08Jan2021 14:00 Departure Condition: Stable, Mobility at Departure: Ambulatory Patient Teaching Discharge instructions reviewed; Follow-up care reviewed; Medications discussed; Patient verbalized understanding. ED Events: Date/Time 08Jan2021 12:27 Patient arrival, Arrival info file, 08Jan2021 12:29 Triage Started, Patient roomed in ED, 08Jan2021 12:32 Assign Attending, Assign Provider, First Provider, Evaluation of Patient, 08Jan2021 12:52 Registration Completed 08Jan2021 12:56 Triage Completed, 08Jan2021 14:02 Patient discharged, ED Tracking End. Follow-up Information: Details Schedule an appointrnent as soon as possible for a visit in 2 days. Specialty: Family medicine Discharge Instructions: You have been given emergency department evaluation. This evaluation is intended to rule out life-threatening conditions. Is not a complete evaluation. You could require further testing as determined by your primary care physician or any referred specialist. Please follow-up with all doctors that you are referred to. Please be sure to take your prescribed medications and follow any specific instructions in the discharge instructions. Please follow-up with your primary care physician within 48 hours. Please have your primary care provider recheck your blood pressure. Please return to the emergency department if you experience chest pain, shortness of breath. abdominal pain, fever greater than 102, intractable vomiting. Please return to the emergency department if your symptoms continue or worsen, or if you begin to experience any other concerning symptom.Discharge References/Attachments: Hives Easy-to-Read AVS Reports: Date/Time: 08Jan2021: Report: COVID-19: Overview & Impact. Date/Time: 08Jan2021 Report: ED after Visit Summary. Chart Review Routing History No routing history on file. Case Management registry, Status: Active, First included on: 08Jan2021 2:20 PM, Emergency Encounter Documentation Registry, Status: Active, First included on: 09Jan2021 12:06 AM, Emergency Encounters Registry Status: Active, First included on: 08Jan2021 12:36 PM. Patient was recovering from the events. Information on the Lot/Batch number has been requested.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of Anaphylactic reaction, hives, itching and Eye swelling cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product. 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.

hives; facial swelling; throat swelling; throat itching; nausea; anaphylactic reaction/ Anaphylaxis; This is a spontaneous report from a contactable physician via FDA. A 49-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in the arm on 17Dec2020 at 13:30 at 0.3 ml, single dose for covid-19 immunization. Medical history included ongoing essential hypertension, ongoing protein c deficiency, ongoing lumbosacral radiculopathy, ongoing type 2 diabetes mellitus, ongoing pulmonary embolism, Strep pharyngitis from 29Nov2020 and resolved at the time of vaccination, serious allergic reaction, allergy to iodonated contrast media and Cardiac Arrest after IV contrast. Concomitant medication included apixaban (unknown manufacturer) for Protein C Deficiency, metformin hydrochloride (unknown manufacturer) for Type 2 Diabetes, chlorthalidone (unknown manufacturer) for hypertension, metoprolol (unknown manufacturer), clonidine hydrochloride (unknown manufacturer) for hypertension, atorvastatin (unknown manufacturer), magnesium oxide heavy;tocopheryl acetate (unknown manufacturer), tramadol hydrochloride (unknown manufacturer), diphenhydramine hcl (unknown manufacturer), epinephrine bitartrate (unknown manufacturer) for serious allergic reaction and anaphylaxis. On 17Dec2020 at 13:48, approximately 13min after vaccination while in observation the patient experienced hives, facial swelling, throat swelling/itching, and nausea. Patient was immediately taken to Emergency Department where epinephrine was given 1M in the left thigh followed by 125mg IV solumedrol, 50mg IV benadryl, 1000mL NS, and 20mg IV famotidine. Hemodynamically stable throughout ED course. The events were considered serious as per hospitalization. Medical Tests and Laboratory results related to the adverse event included: CRP: 11.0, Glucose-182, BRN-29, INR-1.1, Remained of CMP and CBC were WNL. The physician stated that anaphylactic reaction onset 6min after vaccination symptoms improved - 20min after epipen administration, Resolved 60 min later. The signs and symptoms of anaphylactic reaction included Diffuse rash, Itching, throat/lip swelling, shortness of breath, cough, BP 128/72, Spon-97% HR-71. The patient rushed to ED from vaccination PoD. Received EpiPen approximately 8 min post vaccination. Then received steroid, antihistamines, IVF. Sx improved in 20 min resolved 60 min. The patient was not hospitalized and not admitted to an intensive care unit for anaphylactic reaction. The physician stated that multiorgan involvement included respiratory, dermatological/mucosal. Also reported as Respiratory: Yes; Upper airway swelling: Yes; Respiratory distress: Yes; Tachypnoea: Yes; Dry cough: Yes; Difficulty breathing (without wheeze or stridor):Yes; Dermatological/Mucosal: Yes; Generalized urticarial: Yes; Angioedema (not hereditary): Yes; Generalized pruritus with skin rash: Yes. The following laboratory tests or diagnostic studies performed included Hematology on 17Dec2020 showed: results with units, if applicable: 8/13/299/41; Clinical chemistry on 17Dec2020 showed: results with units, if applicable: 137,103,29/36,22,07 (Less than sign) 182; CRP on 17Dec2020 showed: results with units, if applicable: 11.0. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient had anaphylaxis on 17Dec2020 at 13:36. The patient was not deceased and received treatment. Treated in emergency room/ epinephrine IM IV steroids, antihistamines, IV fluids. The physician considered the Pfizer product had a causal effect to the adverse event. The outcome of the event anaphylactic reaction/ anaphylaxis was recovered on 17Dec2020, while other events were recovered on 17Dec2020 at 13:48. Information on the lot/batch number has been requested. Follow-up (08Feb2021): New information received from the contactable Physician included: additional medical history and lab data, concomitant medications details, suspect drug information (lot number, dosage regimen details), event information (new event "anaphylactic reaction/ Anaphylaxis") and other clinical courses.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events anaphylactic reaction/Anaphylaxis urticaria, swelling face, pharyngeal swelling, throat irritation and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Received COVID vaccine 1 on 1/13 and COVID vaccine #2 2/1. 49 y/o previously healthy female who had a COVID 19 exposure ~ 1/3. The person she was exposed to tested positive 1/6 (daughter had a fever and cough). On 1/11 the patient received the 1st dose of the Pfizer vaccine. 12-24 hours after the Pfizer vaccine she developed fevers, malaise, myalgias that lasted 2-3 days (Called off work). She then returned to a normal state of health. On 2/1 she received the second dose of the vaccine. On 2/6 she developed right pleuritic chest pain so went to an urgent care. COVID 19 PCR was positive and CXR unremarkable. She was told to take naproxen and her pleuritic chest pain slowly improved. On 2/8 she started to have general malaise followed by nausea. On 2/11 she developed increased nausea and vomiting followed by diarrhea-eventually that day she had a near syncopal episode prompting her presentation to the hospital. Seen at an outside hospital between 2/11-2/12. CT abd/pelvis showed patchy ground glass opacities at the base of the lungs and she was noted to have diffuse mural thickening. There was concern for possible cholecystitis so a perc cholecystostomy tube was placed. Ultimately she developed significant hypoxic respiratory failure and had to be intubated.She was transferred to another hospital on 2/12. Initially she was started on treatment with dexamethasone but continued to clinically get worse. Also on empiric antibiotics.

Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a full dinner, went to bed at 10:00. Woke at 4:00 am feeling very achy. Went to kitchen for ibuprofen, took two. Started feeling very nauseated. Went to master bathroom to urinate, and started feeling like I was going to faint. Tried to make it three steps to my small sofa outside bathroom door. That?s the last thing I remember. My husband heard me fall. I had fallen chin first on hardwood floor. He found me lying in a pool of blood. Before going to ER in the next 15 minutes, i had an extreme bout of diarrhea. At ER, I learned that I had Broken both my condyals in jaw and fractured lower mandible. At ER and hospital on 2/2, threw up multiple (about 7-8) times, even with anti-nausea drugs in IV. Doctor put an anti-nausea patch behind my ear but not sure if it helped. Had surgery to set it on 2/3/21.

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium

very bad dry mouth starting after first vaccine shot, worsening after second dose, gradually starting to subside 1 week after 2nd vaccine . urination urgency. starting 1 week after the 1st vaccine shot. increasing for 1 week. continuing after second dose. gradually subsiding 1-2 weeks after second vaccine dose. eye pain, sensitivity to light only lasting 1-2 days 10 days after second dose. Pervasive anxiety either from circumstances or vaccine. i dont know. and a one time vaginal bleed a week after 2nd dose.

She reports having a surgery on 1/4/2021. Received vaccine on 3/5/2021 and went to ED on 3/7/2021 and diagnosed with bilateral PE's.

Pt got dose of vaccine Pfizer bionTech Lot # EL1283 with exp 10/22 and had an anaphylactic reaction with dizziness, tongue swelling and shortness of breath. Vaccine given in tent. Pt felt she was going to fall and was assisted down. She was diaphoretic and tongue swollen. Epi pen was administered. Pt with history of sever allergic reaction as a child but has never used epi pen in adult life and sensitive to flu vaccine with eggs. Pt taken to ER.

Anaphylactic reaction: other; This is a spontaneous report received from a contactable consumer (patient). A 49-year-old female patient (not pregnant) received BNT162B2 (lot number: EN6205) second dose on 06Mar202111:00 on Right arm at single dose for COVID-19 immunization. Medical history included Asthma, allergies to Sulfa, CT dye, Reglan, Morphine, and Gastrointestinal issues. Concomitant medications within 2 weeks of vaccination included Omeprezole, metformin, fluticasone propionate, salmeterol xinafoate (ADVAIR), cetirizine hydrochloride (ZYRTEC), galcanezumab (EMGALITY). No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took BNT162B2 first dose on 13Feb2021 13:00 (age at vaccination was 49-year-old) on Right arm for COVID-19 immunization. Patient had Adverse events: Anaphylactic reaction: rash, itching, cough, throat swelling and closing, difficulty breathing, rapid heart rate, face swelling, eye problems, dizziness, nausea, headache on 06Mar2021 11:15. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Patient received treatment included Epinephrine, Benadryl injections, O2, Breathing Tx. Prior to vaccination,was the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was Recovered with lasting effects.

fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse; Dilated cardiomyopathy; fever; chills; vomiting; severely low potassium; fluid build up around her heart and lungs; fluid build up around her heart and lungs; This is a spontaneous report from a contactable consumer (patient's husband). A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration (anatomical location; Arm) on 22Jan2021 13:00 as SINGLE DOSE for COVID-19 immunisation. Patient's medical history was not reported. Concomitant medication included biotin from an unspecified date and unknown if ongoing. The patient previously took 1st dose of the Pfizer COVID Vaccine on 29Dec2020 (around 10:00 am to 12:00 pm at a hospital) and had the usual side effects of a little bit of nausea, developed a dry cough, some fatigue, and diarrhea and that kind of stuff. The reporter called about the Pfizer COVID vaccine and was calling on behalf of his wife who was the patient. Reporter stated that before the Pfizer COVID vaccine, patient used to walk the dogs 6 miles a very fast pace and had no problem, then she got her 1st dose of the Pfizer COVID vaccine on 29Dec2020 and had the usual side effects of a little bit of nausea, developed a dry cough, some fatigue, and diarrhea and that kind of stuff. The reporter stated that after the 1st dose of the Pfizer COVID vaccine, the symptoms she reported have worsened and the cough, fatigue, nausea, and diarrhea began immediately after the 1st dose of the vaccine where the cough started a week or so after the 1st dose and then after the 2nd dose, the cough never went away and got worse and worse and worse. Reporter stated the fatigue, diarrhea, nausea, and cough were all ongoing and have gotten worse. Reporter mentioned that for the cough after the first dose of the Pfizer COVID vaccine, it was still there but was occasional and was not too bad but when the patient had the 2nd dose on 22Jan2021 and was knocked on her butt for about three days; also stated that the patient had fever, chills, diarrhea, vomiting, nausea and the works and had all the symptoms. It was also reported that the patient was very sick for 3-4 days with same symptoms. Reporter mentioned that fatigue was getting worse and the cough never went away and always had the dry cough which was getting worse and worse and worse with any activity and was a dry cough and she never had any phlegm. Reporter also stated the patient got to where she did less and less activity and was worse and the dry cough was worse with nothing coming up. It was reported that the patient sought treatment for everything she believed last week on Monday but was unsure of the dates. Monday of last week, patient went to the emergency room in a hospital and was told that they thought that the patient had an enlarged heart and severely low potassium and the patient was put on an IV drip of potassium because she could not tolerate the oral potassium and threw up the oral potassium so she was put on two bags of IV potassium. On an unknown date, it was reported that patient started having pain in her chest from the IV drip of potassium but she was released from the emergency room and the 2nd day of last week which was the next day, patient went back to the emergency room because she was having issues and everything was getting worse. Reporter also stated that the 2nd of last week, the patient collapsed and an ambulance came and got her on Tuesday of last week though reporter was unsure of the dates. Reporter also mentioned that patient went to a hospital and had severe chest pain and collapsed pressure on her chest. Reporter stated that the patient at that time had the dry cough and stuff and the hospital told the patient that the patient had fluid build up around her heart and lungs which was maybe due to the treatment from the IV potassium and was told she has a weakened heart. It was reported that with a weakened heart, the heart can't process fluid around the lungs and the heart and it puts pressure on heart supposedly. It was reported that on Wednesday last week, the patient went to the emergency room for the 3rd day in a row and already had an appointment with the HCP which was an appointment with her new primary Nurse Practitioner for the first appointment and she confirmed that the patient had fluid on the lungs when she saw the patient. Reporter stated that the nurse practitioner could not admit the patient because the hospital she admits too was full so she sent the patient to a hospital emergency room where they did all the tests and everything confirmed what they said and they transferred the patient to another hospital where the patient stayed in the hospital a total of three days and was diagnosed with cardiomyopathy and they started treatment on the patient. The patient was started on Entresto later on and tomorrow there was a follow up visit with her primary HCP and they have to follow up because the patient was released from the hospital and was very weak and she has to wear a lifevest because she is a heart patient and has a weak heart. It was reported that patient is going to be taking medications and stuff and will go see the HCP and they gave her beta blockers and other stuff and she will follow up with the HCP. It was reported that any of the medications including the beta blockers the patient was taking, reporter has no names of the medications, dosages or lot numbers or other information to provide at this time and stated that the patient was treated with those medications in the hospital and that was the hospital in another city and state. Reporter mentioned that it was last week when the patient collapsed while trying to walk across the yard and she was diagnosed with dilated cardiomyopathy where part of the heart shrunk which is the expelling chamber of the heart and the HCP stated where a normal 20-30 year old would have heart function of 55, the patient had an output of 15. Reporter stated that the HCP said that stroke, disease or things like that can cause cardiomyopathy and there are various things that can cause it but they can't diagnose what caused this in the patient because she has not had various things and the only she had was the Pfizer COVID shots that hit her very hard and she just turned age 50. Reporter stated that the patient was age 49 at the time she began experiencing the symptoms that were reported and just turned age 50. Reporter clarified to state the potassium drip the patient had was not at this hospital but was at another hospital. Reporter stated he has no lot numbers, expiry dates or NDC numbers to provide as he does not have the patient card for the Pfizer COVID Vaccine that the patient received and that paperwork is with the patient who is staying at her sister's house so the sister can help monitor the patient. Reporter also mentioned that patient was not taking medications at the time she received the Pfizer COVID Vaccine at that time but was taking over the counter Biotin and states he has no lot, expiry date or UPC to provide. Reporter mentioned that patient has no family history of heart conditions but he thinks the patient's mother is diabetic but she is the only who is diabetic and there is no other history he is aware of. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

reported to onsite medical clinic at 11:30am after taking 2 puffs of albuterol, c/o HA/lightheaded/dizzy, VSS, developed mild SOB/clammy/groggy, sent to Emergency Room for evaluation and treatment where it was documented that she had an anaphylaxis reaction to the vaccine administered at 0800 on the same day at a community vaccination event

Blood clot in LAD which caused a STEMI; Blood clot in LAD which caused a STEMI; This is a spontaneous report received from a contactable consumer (female). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), first dose via an unspecified route of administration, administered in Arm Left on 20Mar2021 08:15 (at the age of 49 years old), single dose for covid-19 immunisation. Medical history included hypothyroidism, Penicillin allergy, both from an unknown date. The patient was taking unspecified concomitant medications within 2 weeks of vaccination. The patient experienced blood clot in lad which caused a STEMI on an unspecified date (reported as 03Mar2021 15:15, for clarification since before vaccination date). The outcome of the events was unknown. The events was assessed as serious, causing hospitalization, disability and was life-threatening. Treatment for the events were Balloon in LAD / clot buster. The patient underwent lab tests and procedures which included COVID-19: negative on 03Mar2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Information on Lot/Batch number was available. Additional information has been requested.

pneumonia; congestion; Vomiting; Chills; cough; exhaustion; headache; ears burning; lung pain; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration, administered in the left arm on 27Mar2021 at 09:45 as a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had no known allergies. The patient did not have COVID prior to the vaccination. Concomitant medication included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, start and stop date were not reported. On 28Mar2021 at 12:30, the patient experienced vomiting, chills, cough, exhaustion, headache, ears burning, lung pain, shortness of breath and congestion. The patient went to doctor on 30Mar2021 and apparently, she has pneumonia. The patient also mentioned that she barely had a stuffy nose before taking the vaccine. The patient has a rapid response nasal swab COVID test on 29Mar2021 with a negative result and a PCR nasal swab COVID test also on 29Mar2021 with an unknown result. It was unknown if the patient received treatment for the events. The outcome of the events was not recovered. Information on the batch/lot number has been requested.

Anaphylactic Reation. everything swelled and rash appeared, couldn't swallow, throat constricting. Epinephrine injection, Racepinephrine, diphenhydramine methlprednisolone, famotidine Day after feel like run over by a truck and nausea, feel sick, headache, joint pain not sure how long everything will last or if more will appear

I had not had a period for 25 years since I was in my 20s and had reached such low weight I stoppexhaving periods. Even when I reachednormal and slightly above normal weight I didn't have a period . A day and a half after the second vaccine dose (yesterday) i have had continuous light flow blood...it continues today and I have tummy pain similar to what I had when menstruating in my youth

STARTING FEELING SLUGGISH/ TOOK A NAP/ THEN WHEN AWOKE COULD NOT MOVE LEFT SIDE OF BODY/ WENT TO ER AND WAS DIAGNOSED WITH MINI-STROKE WITH POSSIBLE MS ---STILL FEELING WEAK

my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; I was afraid I was having a heart attack; Initial hyperactivity; tiredness; chest pains; urge to vomit; body aches all over; This is a spontaneous report received from a contactable consumer (patient herself). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration in left arm on 01Apr2021 at 16:00 (at the age of 49-year-old) as a single dose for COVID-19 immunization. The patient's medical history included issues with anemia in the past and known allergies: Tree nuts was all that I am aware of (allergies to medications, food, or other products: Tree nuts was all that I am aware of). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccine within four weeks of vaccination. The patient did not receive other medications within two weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. No COVID prior vaccination. The patient was not tested for COVID post vaccination. It was reported that the, initial hyperactivity on 04Apr2021 (patient think it was the anticipation of the shot), followed by tiredness that evening on 04Apr2021, Friday, Saturday, and Sunday. With the exception of having lunch with a friend on Saturday and stopping by to check on her mom, patient stayed home all weekend because she was feeling very tired. Late Sunday night after going to bed she awoke with chest pains and the urge to vomit on 04Apr2021. Patient was up and down vomiting for several hours and began to experience body aches all over on 04Apr2021. At one point she was afraid she was having a heart attack on 04Apr2021. On Monday morning and throughout the day she was still experiencing body aches and stayed home from the office. Patient slept propped up on the living room sofa Monday night because lying down made her body aches worse. Today, Tuesday 06Apr2021, her right leg was still bothering her, it feels a little bloated, so she was walking slower than usual. Otherwise she feel normal. The events were considered as serious (life threatening, hospitalization) by the consumer. No treatment medications were received for the adverse events. The outcome of the events was recovering. Information on the lot/batch number has been requested.

microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with coagulopathy; thrombotic microangiopathy; jaundice; nausea; vomiting; diarrhea; This is a spontaneous report from a contactable physician. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 29Mar2021 13:45 (Batch/Lot Number: ER8733) as single dose for covid-19 immunisation. Patient was not pregnant. The COVID-19 vaccine was administered at Doctor's office/urgent care. Medical history included Metastatic breast cancer. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant Therapy included Clinical trial oral drug - ARV-471 on 22Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient presented to the hospital on 05Apr2021 complaint of (c/o) 1 week of jaundice, nausea, vomiting, and diarrhea, which started on an unknown date in Mar2021, and on 05Apr2021 found to have evidence of microangiopathic hemolytic anemia, thrombocytopenia, and severe hyperbilirubinemia/cholestasis with coagulopathy. Work-up revealed like thrombotic microangiopathy although etiology unclear. ADAMTS13 level 29 with no inhibitor not suggestive of Thrombotic thrombocytopenic purpura (TTP). Patient eventually died of this acute presentation. She also had a history of metastatic breast cancer and had also just started taking a phase 1/2 oral clinical trial drug ARV-471 on 22Mar2021. Unclear if the drug, COVID vaccine, or breast cancer may have contributed to current illness. Adverse 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), Patient died. Patient hospitalized for 5 days. Date of Death was on 09Apr2021. Death cause: Death certificate stated metastatic breast cancer. No autopsy performed. Therapeutic measures were taken as a result of events included plasmapheresis, steroids, antibiotics. The patient underwent lab tests and procedures which included Nasal Swab: negative on 05Apr2021. The outcome of the events was fatal.; Sender's Comments: Based on temporal association and the limited information available, the causal association between BNT162B2 vaccine and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: severe hyperbilirubinemia/cholestasis with coagulopathy; jaundice; nausea; vomiting; diarrhea; microangiopathic hemolytic anemia; thrombocytopenia; severe hyperbilirubinemia/cholestasis with coagulopathy; severe hyperbilirubinemia/cholestasis with co

Patient received first COVID vaccine 3/29/21. Patient received second COVID vaccine 4/19/21 in the morning - patient developed headache and severe vomiting throughout the day 4/19/21 resulting in diabetic ketoacidosis (glucose 583 mg/dL) and systemic inflammatory response syndrome (SIRS) - patient admitted 4/19/21 in evening to ICU - patient discharged 4/21/21. Patient states she had COVID disease last year.

I received my first Pfizer vax on 03/30/21. On 04/14/21 I started having some sensations in my right leg and on 04/19/21 I started getting pain in my right calf so I went to the Emergency Room where they performed an ultrasound and said I had a DVT in my peroneal vein in my right leg. I was prescribed 15 mg of Xarelto twice a day for 21 days. Prior to this incident I have been on Xarelton 20 mg/day for life since October of 2014 for an "idiopathic" blood clotting disorder.

I waited about 30 minutes. Felt tingly and a bit light headed but cracked it up to being tired from the shot. I got in my car and about 5 minutes out driving in the middle of traffic, I felt like I was going to pass out like I had once before with anaphylaxis- at the wheel. There is no mistaking the feeling. I could not feel my pulse at all. Fortunately I had a EpiPin in my car and I was able to jab it in my leg and within a minute or two I had the energy to turn the car around and get back to the folks at site who were wonderful. I then took benadryl as advised and the EMS were called. I was taken to site where they gave me a steriod, pepsid and monitored me until I went home later that evening. I was told to take benadryl for the next 24 hours and I did.

she thought she had a blood clot; maybe it is MS (multiple sclerosis); possible septal infarct; weakness in her left arm; losing her balance; vaccine was given up high on her arm, not 2 fingers down. She thought they had hit bone; less range of movement in her left foot; trouble walking; like someone who had a stroke; numbness; legs felt heavy climbing stairs; immediate pain when needle went all the way in and worse when vaccine went in; pain in shoulder joint; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Ep6955), dose 1 via an unspecified route of administration, administered in Arm Left on 25Mar2021 18:00 (at the age of 49years) as single dose for Covid-19 immunization. The patient is not pregnant at the time of vaccination. Medical history included anemia that is treated, living kidney donor, gastric bypass in 1999, gallbladder removal, hysterectomy, intussusception x2, migraines, high heart rate, and smoking. Concomitant medications included omeprazole (OMEPRAZOLE), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]); all taken for an unspecified indication, start and stop date were not reported. The patient previously received Flu vaccine and Tetanus vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. She got the shot on 25Mar2021 on Thursday evening at 1800. She is 49 years old and has had all the flu shots and tetanus shots. She has never had one hurt so bad. She stated that the vaccine was given up high on her arm, not 2 fingers down. She thought they had hit bone. It was reported that the patient experienced immediate pain when needle went all the way in and worse when vaccine went in. The whole time it hurt really bad and her arm hurt severely for 2 days from 25Mar2021. She still has pain in shoulder joint. That aside wasn't a big deal, it went away even though the joint is sore. The following Monday 29Mar2021 in the evening, her legs felt heavy and she had trouble going up the stairs. Then she had complete numbness of her left leg, from her hip or butt crack to the tip of her toes. It was on the same side she had the shot. It was further reported that the patient's legs felt heavy climbing stairs then she woke Thursday morning with her left leg numb. She couldn't feel herself starting to have a bowel movement because the numbness went all the way up to that area. She went to the ER (emergency room) on Saturday night (03Apr2021) because she was afraid of a blood clot. An ultrasound was done on her left leg, CT of head and neck, and blood work with nothing found. She has numbness and less range of movement in her left foot with trouble walking and have had no improvement with calf being numb. It was further clarified that when she was Easter shopping, there was numbness in her foot was causing her to drag her foot around the store. It was like someone who had a stroke, with slight impairment on one side. Her foot slaps the floor. She doesn't have control of it, she can't flex her foot up and down at all and she has little movement in her toes, even now. When she went to the emergency room, she thought she had a blood clot. She is a kidney donor and is healthy over all except for anemia that gives her tingly toes since she was 30, off and on. She never had a body part felt so numb, other than when she sits on her leg wrong. They did a bunch of tests there. They did a doppler, CT scan, and an EKG (unspecified date) which was abnormal. Her EKG has never been abnormal before. It said possible septal infarct undetermined time. The doppler showed no deep or superficial blockages noted from her groin down to her toes/ankle. The doppler was to check for blood clots. They referred her to her primary care provider who said that she will do a neurological exam. She has weakness in her left arm as well. The weakness in her left arm was only told by the neuro touch test. The patient further clarified that she doesn't have less range of motion, it is really just pain (arm). She can still move her arm all the way. Her left side is weaker or less sensitive as far as the neuro test. She wasn't aware she had less feeling on her arm until the nurse said she did. Her arm pain is nothing significant, it can hurt when moving her arm. She had no leg pain or anything like that until later in the week. She still had symptoms of losing her balance. Getting in and out of the chair she almost fell down. She didn't realize the numbness. Monday, she felt heaviness going up the stairs. For 2 days she had the worst pain ever in her arm. She had the tetanus shot and didn't have anything like that. It went away, when she raises her arm off from the side, she still has pain in the joint. She has migraines, it is nothing that is causing difficulty. She is more concerned something else happened. Patient thought maybe it is MS (multiple sclerosis) and asked if it is peripheral artery disease. She did smoke half a pack every other day. She is 49 but didn't start smoking till she was 36. It is a terrible habit and her doctor is aware. She also had her good and bad cholesterol which was just over 100. She is just reporting it because it happened on only the left side and she is a healthy person. She never had high blood pressure and never been treated for it, but she has had high heart rate before. It is not something that has ever caused any issue. She doesn't have something like peripheral artery disease, when she (software company name withheld) that is said plaque in the arteries. The doppler showed no signs of blockage superficial or deep on that side. She doesn't have an appointment until 29Apr2021. She doesn't know what to do to get more urgent care. The pain in her arm was better after the first 2 days. It is like a tooth ache, a dull ache. It is not all the time, just when moving her arm. Her legs were worse to where Thursday, she woke, and she was numb from the top of her leg to the tip of her toe. She can still lift her leg, but when she walks the tip of her second toe which is longer will drag on the ground. When she walks it is hard to hold her shoe on the left foot or put her shoe on. She can't maneuver her foot. When her foot hits the ground, the ball area of her foot smacks the floor because she doesn't have control over it. It is laboring to walk and is hard. She was kind of limping and pulling that leg on the left side. Her laboratory tests were BMP, CBC auto diff, CBC with diff, CT, angiogram of the head and neck, EKG 12 lead, and they did a venous doppler of the left lower extremity. It all came back good except the EKG which says septal infarct undetermined date, which has never come up on any tests before. The events resulted in Emergency room/department or urgent care, Disability or permanent damage. There was no treatment received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of events was not recovered.

Patient began very heavy menstrual cycle, 2 weeks earlier than expected, 6 days after receiving second Pfizer COVID-19 vaccine. She is bleeding through maxi pads every 15-30 minutes, passing smaller than quarter-sized clots, with associated severe menstrual cramping, when she previously had no history of this.

I was diagnosed with a blood clot in my right leg; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in right arm on 03Mar2021 15:45 (Lot Number: EN6202), at the age of 49-years at vaccination, as SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient is not pregnant at the time of vaccination. The patient received dose 1 of the vaccine on 10Feb2021, lot number: EM9810, on 10Feb2021 03:45 PM at right arm. The patient did not have COVID-19 prior vaccination. The patient's concomitant medications were not reported. On 04Mar2021 12:00 AM, patient was diagnosed with a blood clot in her right leg. The event required emergency room visit. The patient was put on Xarelto, a blood thinner for clots. The patient has not been tested for COVID-19 post vaccination. The outcome of the event was unknown.

Went to ED after vaccination reaction - diagnosis: Anaphylaxis CHIEF COMPLAINT: POSSIBLE ALLERGIC REACTION (ptjust had 2nd COVID vaccine. c/o voice changes and changes in swallowing. pt is able to maintain secretions at triage. ) DIAGNOSIS at time of disposition: 1. Anaphylaxis, initial encounter This is a 49-year-old female that presents emergency department 1 hour after receiving her 2nd COVID vaccine (pfizer), and states that she waited her 15 minutes after receiving the shot and felt fine. She then reports that when she got to the car she started feeling some chest tightness a bit of more difficulty with her breathing and felt like her throat was scratchy and a bit tight as well. She has had complications with taking the flu vaccine as well as a tetanus shot. Where she has had rashes then enlarged lymph nodes. But never this reaction. She has never been hospitalized or brought to the ER due to anaphylaxis. She does not use an epinephrine pen at home. Patient states before the shot she was feeling well. She does not have any systemic symptoms like fever, nasal congestion or sore throat. Patient also denies any recent episodes of vomiting or diarrhea. This patient came in the emergency department was concerning signs and symptoms for anaphylaxis. The patient was immediately given a dose of IV Solu-Medrol 125 mg, IV Benadryl 50 mg, and 20 mg of IV Pepcid. Patient was placed on cardiac monitor. I went back to re-evaluate the patient she was feeling significantly improved within a short period of time. Patient was monitored in our emergency department for most 2 hours. Patient's symptoms had resolved. Patient was comfortable being discharged home. Patient has several allergies in her history. Patient was sent home with a prescription for prednisone as well as Pepcid. Patient also given a prescription for an epinephrine pen and told and instructed on how and when to use this. The patient is going to have someone pick her up as she was instructed that the Benadryl can make her very drowsy and a would be rather unsafe to drive. She was going to contact a family member to pick her up. Patient will return if she has any more symptoms

(1) Pulmonary embolism: Unclear whether there had been a provoking event. Reports symptoms for about a week. Left lower extremity VTE found on ultrasound requested by her PCP. She reports she may have had COVID-19 in December. She reports she had just completed second dose of COVID-19 vaccine on 4/15. Appears it would give about 7 days since the second dose, and onset of her symptoms. She does state she had been somewhat less mobile after her illness. She does not smoke. She is not on any hormone therapy. Not entirely clear that this is related to the vaccination, however, will discuss with pharmacy regarding whether this should be reported. We discussed anticoagulation. She started on Lovenox and ER. Discussed subsequently switching to oral anticoagulation. We will assess TTE. Monitor oxygenation, blood pressure, heart rates. Status: Acute (2) Deep vein thrombosis of lower extremity: Initiated on anticoagulation as above. Ultrasound reports VTE including common femoral vein. We will try to see if we can get a limited study to assess more proximal veins. Discussed with her in case of concern symptoms, iliofemoral VTE, consideration may be given as well to catheter directed TPA. She understands that this procedure is not available at the current facility. We discussed also regarding possibility of post phlebitis syndrome, especially with more proximal VTE. Discussed strategies going forward to reduce the symptoms.

Presented to ED with swelling to right leg. Had ultrasound and has a DVT. Normal cardiopulmonary exam with LCTAB and HRRR. No swelling to R calf. R calf is warm to touch, red, and TTP. Patient is well appearing, non-toxic and in no acute distress. Patient's US of the RLE that revealed a R calf DVT involving mid calf posterior tibial vein from her Dr.'s office. BMP was unremarkable. Prescribed the Patient Xarelto and she received her first dose in the ED today. Follow-up with PCP in the next 2-3 days. Return to the ED for new or worsening symptoms.

Site: Swelling at Injection Site-Mild, Systemic: bleeding down arm/pt concerned of non OSHA compliance(lack of glove use to wipe dry blood off of arm)-Mild, Additional Details: pt's vaccine site started bleeding after needle was removed. immunizer cleaned the blood that was dripping down her arm off with a glove on and made sure she stopped bleeding, but took blood covered glove off and finished wiping off the dry blood with an alcohol swab. Patient called and told pharmacist her concerns about the incident.

Exactly a week after receiving my second shot I had a heart attack. No family history, no risk factors. Low blood pressure and low cholesterol, no smoking, no drugs. Hospitalized at Heart Institute.

Feeling Tired; Headaches; Passed away; found dead in her bed; Was not feeling well; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 11Apr2021 (lot number: ER8729) at the age of 49 years old, as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included naproxen sodium (NAPROSYN) taken for an unspecified indication from 05Apr2021 to an unspecified stop date; and benzonatate taken for an unspecified indication from 05Apr2021 to an unspecified stop date. The patient previously received first dose of BNT162b2 on 21Mar2021 (lot number: EP6955) at the age of 49 years old, for COVID-19 immunization and experienced fatigue, legs were hurting, dry cough, and really bad headaches. No other vaccines received in four weeks. The caller's friend (patient) got her second dose on a Sunday (11Apr2021). Monday, (12Apr2021), the patient went to work, but left because she wasn't feeling well. The reporter stated that the reporter did not speak to her friend (patient) directly on this day but was told that her friend (the patient) was feeling tired and having headaches. The reporter stated that her friend died early Tuesday morning 13Apr2021. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 05Apr2021. The patient died on 13Apr2021. An autopsy was performed, and results were not provided. Outcome of events 'was not feeling well', 'feeling tired', and 'headaches' was unknown.; Reported Cause(s) of Death: Passed away; found dead in her bed

Severe pain at site, arm, fingers, and shoulders for the first couple of days; and then itchiness of legs. April 27- manifestation of rash behind both knees and upper calves. April 30 swelling and edema in both calves. May 1- Swelling to left foot. Symmetrical pain in pressure points. May 2- Severe swelling to both feet, and both calves (left side, which was injection side, was worst on lower extremities). Right eye was almost swollen shut. Left eye was beginning to swell. Severe swelling to face, neck, jaw, and throat, as well as tightness of throat. Anaphylactic reaction. Emergency room visit on the May 2, May 3 was a bad day, filled with pain in joints and pressure points, as well as swelling in feet and calves. Followed up visit to pcp on May 4. Still have rash, itchiness, and swelling of lower extremities. Today, May 8, still experiencing swelling, pressure point pain, and manifestation of rash, as well as it's itchiness.

Healthy 49 yo female with no genetic disposition, no high blood pressure, no high cholesterol, not diabetic, had a moderate to severe stroke with NIH stroke score of 19 upon admission to ER. TPA administered,

2 weeks after vaccine noticed pain; Swelling; Tenderness; redness; lump on left leg; Superficial clot and other DVT clot found; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female consumer received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), from lot ew0153 as single dose via unknown route at the left arm on 06Apr2021 11:30, at the age of 49 years, for COVID-19 immunization. The patient was not pregnant. Medical history included, in 1996 while on oral contraceptives had a blood clot in left leg. Prescribed Coumadin for year. Went off, bad leg swelling occurred. Prescribed compression stocking. Genetic test discovered Factor V Leiden mutation heterozygous. Since 1996-1998, have had bad swelling in left leg but no further clotting. Last time ultrasound was needed to confirm leg was just bad swelling was approximately 2007. No other clotting since around 1996-1998. Concomitant medications were not reported. On evening 20Apr2021, 2 weeks after vaccine, noticed pain, swelling, tenderness, redness and lump on left leg. Went to doctor on 21Apr2021. Ultrasound performed. Superficial clot and other DVT clot found. Prescribed Xarelto. The outcome of the events was reported as recovering. No covid prior vaccination and the patient was not tested for covid post vaccination.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Severe

bruising with blood under the skin; scratched right leg and it bled profusely; scratched right leg and it bled profusely; Low grade fever; Face, Neck and Ears turned bright red; headaches; fatigue; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered on right arm on 22Apr2021 10:30 (Batch/Lot Number: EW0169) as 2nd dose, single (at the the age of 49 years old) for covid-19 immunisation. The patient medical history was not reported. allergies: Tetanus, metronidazole. Concomitant medications included levonorgestrel (I PILL) taken for an unspecified indication, start and stop date were not reported. The patient previously took tetanus (TETANUS TOXOID) and metronidazole and experienced known allergies; BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered on right arm on 01Apr2021 12:00 PM (Batch/Lot Number: R8733) (at the the age of 49 years old) for covid-19 immunisation and no reaction on previous exposure to drug. The patient experienced low grade fever on 27Apr2021. Face, Neck and Ears turned bright red, headaches and fatigue on 23Apr2021. Day 4 after injection (26Apr2021), scratched right leg and it bled profusely, with difficulty stopping the bleeding. Day 5 after injection (27Apr2021), had blood drawn from left hand with butterfly needle. When it was removed immediate bruising with blood under the skin, larger then a half dollar coin. Hospital added to check platelet count specimen order. The patient stated that this is very abnormal for her. Prior to vaccination, was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. It was unknown if the patient received treatment for the events. The outcome 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. 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.

Heavy vaginal bleeding with clots, cramping in uterus and tenderness in this area prior to onset of bleeding. Vaginal bleeding lasted for 6 days. Please note that this was not like a regular menstrual period and I was not due for my period. I also bled after my first Pfizer vaccine but it was not alarmingly heavy like it was after this second dose. After this second vaccine dose, I was fatigued during the bleeding and after. The fatigue was resolved two weeks after I received the second vaccine. One other strange side effect was that three days after I received the second vaccine my left hand was slow to respond when I needed to type on the computer. This lasted for several days.

Got diagnosed with mild stroke after a high blood pressure crisis; Got diagnosed with mild stroke after a high blood pressure crisis; blurry vision on the left eye; Pins and needles feelings in left body side; headache; memory loss; This is a spontaneous report from a contactable consumer (reporting for herself). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 13Mar2021 at 10:00 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included high blood pressure, and asthma. The patient's concomitant medications were not reported. On 14Mar2021, the patient was diagnosed with mild stroke after a high blood pressure crisis and the symptoms showed days after the vaccine such as blurry vision on the left eye, pins and needles feeling in left body side, headache and memory loss. 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. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The events resulted in emergency room/department or urgent care and was admitted in the hospital for 2 day. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.

Saturday April 3,2021 shortness of breath went to hospital on April 12th with multiple unprovoked PE's Stayed in hospital 6 days and released without oxygen Given blood thinners to take for life Right side of heart damaged due to blood clots

I am anaphylactic survivor. I felt it instantly after the shot: pain up my neck, left side of my back & shoulders, then few minutes later metallic taste in mouth, then nose was stinging, then runny nose and then a few mins later shortness of breath. Told my family about it and they said it was probably side affect, minor/seasonal allergies and that I could take Claritin-D 24-hr. It appeared to have minimized the shortness of breath, which comes & goes every few (15 or 30) mins, but still runny nose. I took for 3 days. When I stopped taking Claritin-D 24-hr on Wed in the AM, in the afternoon, started to have difficulty breathing and runny nose. But it was stronger, shallow breathing. So I took Claritin-D 24-hr again but it wasn't working that well, so, took Benedryl at night as well. Then I took an additional Benedryl. I still have the symptoms but manageable with the allergy meds.

The patient is a 49 y.o. female who reports onset of flu-like symptoms including headaches, intermittent fever, nausea and vomiting, and chills within 3 hours of receiving her first COVID-19 vaccination on 4/2/2021. She reports symptoms increased in intensity such that it required her to seek evaluation in the ER on 4/4/2021. Patient states she was tested for COVID-19 and received positive results. She states she was diagnosed with viral pneumonia and COVID-19 and was discharged home. She received IV infusion therapy for the positive COVID-19 result on 4/7/2021, went home and took a nap and was awoken with severe chest pains and shortness of breath. She was taken to the ER via ambulance where she was diagnosed with atrial flutter with rapid ventricular response and acute hypoxic respiratory failure secondary to COVID-19 infection. Patient was admitted to the hospital.

acute DVT of left peroneal vein (in the left calf); This is a spontaneous report from a non-contactable consumer (patient). This 49-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number not provided), via an unknown route, on 29Apr2021 11:30 (at the age of 49-year-old) at single dose in the left arm for COVID-19 immunisation. No relevant medical history was provided. No other vaccine was received in four weeks. Relevant concomitant medications included ibuprofen (ADVIL 12 HOUR). From 03May2021, the patient developed sharp, piercing pain in my left calf over several days. The frequency increased the early morning (06:00-09:00) of 09May2021 so she contacted her primary care physician to discuss what she thought might be an indicator of deep vein thrombosis (DVT). She presented to the Emergency Room the morning of 09May2021 and was diagnosed with acute DVT of left peroneal vein (in the left calf). She was given blood thinner. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Pulmonary embolism. I experienced shortness of breath and rapid heart rate a few days before my second dose. It worsened and I sought treatment on 4/28/2021. I underwent pulmonary arteriogram with mechanical bilateral thromboaspiration to remove the clots and received blood thinners.

49 y/o female without significant PMH other than anaphylaxis from a dental procedure, who presents to the emergency room with multiple complaints after receiving her second SARS-CoV-2 Pfizer vaccination today at about 3-3:30 PM, lot number not current available. The patient's significant other/boyfriend was driving when he noticed the patient suddenly started to complain of shortness of breath with chest pain and a maculopapular rash which later was followed by expressive aphasia and left hemiparalysis. She received Pepcid, solumedrol and Benadryl for the rash in the ER with improvement. Code neuro was called and TPA was given. Post TPA she was alert and oriented and she could currently write with her right hand and think of the words she has to say. She had associated blurry vision which has resolved after TPA was administered. She also was not able to move her left lower extremity nor her left upper extremity which is also improving to some extent after TPA administration. So far CT/CTA head and CTA neck are negative and she has been admitted for likely acute cerebral vascular accident.

I had a mild heart attack on Sunday 5-30-2021. Because I have had the covid vaccine i was told I should report having the heart attack.

four hours after injection: tightness and itchiness in throat; respiratory symptoms 2 days after injection: fever, thrombocytopenia, flank pain and dark urine

On March 23, 2021, I began having an extremely heavy menstrual flow, passing clots and requiring protection to be changed at least hourly which lasted approximately three weeks. There has been no period since that time. Previous periods were irregular presumably related to peri-menopause, but were never heavy enough to change protection more often than every 4-5 hours and never lasted longer that 4-5 days.

So I had some excess vaginal bleeding to the point I thought I was going to the emergency room. This was May the 2nd 2021. On the 3rd of May I phoned the DR and they gave me Tranexamic acid tablets. I took that for several days until the symptoms subsided. I did have this happen seven years ago and had to get blood transfusions. This time, it started on that Sunday night and had resolved by Thursday.

After 10 hours of 2nd dose, I experienced anaphylaxis - rash all over my entire body, nausea, low blood pressure and my body was shaking from being so cold even though I felt like I was on fire from the inside.

flushing, difficulty breathing, rapid heart pulse (146), elevated blood pressure (183/103). Last anaphylaxis 8 years ago with allergy shot; received 2 epi-pens. Fortunately, 2nd dose was done at the Urgent care setting.

ITP (immune-mediated thrombocytopenia); This is a spontaneous report from a contactable other HCP (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 15Apr2021 13:15 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunisation; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included premature menopause. Patient not diagnosed with COVID-19 Prior to vaccination. The patient previously took penicilline and sulfa drugs and experienced allergy. Concomitant medications within 2 weeks of vaccination include Multivitamin and paracetamol (TYLENOL). No other vaccines within 4 weeks prior to the COVID. The patient experienced ITP (immune-mediated thrombocytopenia) on 23Apr2021. Patient received immunosuppression with steroids for the event. The outcome of event was not recovered. Patient received dose 2 administered in left arm on 06May2021 13:15 (Batch/Lot Number: EW0175). Patient has not been tested for COVID-19 Since the vaccination.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event of Immune-mediated thrombocytopenia cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available.

15 minutes after vaccination patient complained of arm tingling and numbness as she attempted to check out. we asked her to stay a few more minutes to make sure she felt ok. she sat back down and started coughing. we asked her to take her mask off so she could breathe easier. she started to wheeze. we asked about previous allergies and she confirmed that she had anaphylaxis to 2 different vaccines (tetanus and MMR). we monitored her breathing which became more labored. she started to lose consciousness. we administered an epi-pen in the right thigh. within seconds her breathing relaxed. we called for the emergency department. they came and transported her to the ED for further evaluation. she was treated with antihistamines and solu-medrol and then released.

Began to feel side effects of body aches, chills, lethargy within 12 hours after 2nd Covid-19 vaccine. At 4am the day after the vaccine, I felt nauseated and feverish. Within seconds afer taking nausea medication, I fainted. Not sure how long I was unconscious, but there was a large pool of blood under my head and I was very cold. I managed to get back into bed and called my husband who was out of town. He called a neighbor who came and got me around 5:15 am, and took me to the emergency room. I arrived nauseated, with a headache, & bleeding from a wound above my right eyebrow. I was given a head CT scan & stitches to close my head wound. CT Scan was negative for brain trauma, but I did suffer a concussion.

Patient had anaphylactic reaction around at 6pm after getting 2nd vaccine (1st was also Pfizer) at 2pm, and went to hospital. According to patient she did not do anything different on that day other than getting a vaccine.

13 hours after the patient had had her 2nd covid-19 shot, she was found dead. She had indicated that she had no side effects after her shot.

Anaphylaxis; This is a spontaneous report received from a contactable consumer or other non hcp. A 49-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EWU185) via an unspecified route of administration in left arm on 13May2021 at 19:00 (age at vaccination 49 years old, Pregnancy at time of Vaccination: No) as first dose, single for COVID-19 immunization. Medical history included Sjogren's syndrome, Reynauds, Ankylosis, Spondylitis and multi-nodular thyroid. Patient was allergic to Amoxicillin, Lamotrigine, Gabapentin, IV Contrast, peanuts, tree nuts and shellfish. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included lithium (LITHIUM), cariprazine hydrochloride (VRAYLAR) and amfetamine aspartate monohydrate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (MYDAYIS). Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced anaphylaxis on 13May2021 at 19:00. The event resulted in Emergency room/department or urgent care. The patient received treatment for the adverse event in hospital. The patient was hospitalized for anaphylaxis on an unspecified date in 2021. The outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.

Had a CT chest which revealed pleural effusion, and pericardial effusion.; Had a CT chest which revealed pleural effusion, and pericardial effusion.; I started having left-sided chest pains.; chills; night sweats; I had an increase in joint pains.; This is a spontaneous report from a contactable consumer reported herself. A 50-year-old female patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19, Solution for Injection, Lot number: ELO140), via an intramuscular route on left arm 21Dec2020 at 13:00, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. the patient does not have any medical illness. No known allergies have been reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On an unknown date, during the month of December, after taking the first covid shot, patient experienced an increase in joint pains which continued throughout the month of January. In Feb2021, she started having chills at sundown with night sweats. But no fever, no cough. On 28May2021 at 15:00, she started having left-sided chest pains. No cough, no fever, no chills. On 03Jun2021, patient went to the emergency room at work and had a CT chest which revealed pleural effusion, and pericardial effusion. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included admission to emergency room/department or urgent care for 3 days and received IV Doxycycline, IV Rocephin, Toradol, Losartan, Pepcid and Colchine. On an unknown date, patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19, Solution for Injection, Lot number: EL 3302) on the left arm as a single dose for covid-19 immunization. The patient underwent lab test and procedure which included post vaccination covid tests, nasal swab rapid test on 03Jun2021, test result: negative and covid PCR test on 04Jun2021, test result: negative. The clinical outcome of the events was recovered on an unknown date. Information on batch/lot numbers are available. Further information has been requested.; Sender's Comments: Based on the information available and 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.

April 1st, I had leg pain and swelling. I went to the doctor - I had a blood clot in my leg. I had to go on blood thinners.

New onset Afib with RVR, chest pain and severe shortness of breath, woke from a sound sleep 3.5 weeks after second vaccination. Isolated incidence, no previous cardiac issues.

The clots are thick and heavy; My periods have become increasingly heavy, longer, and painful since the second dose; cramps are extremely painful, erratic/My periods have become increasingly heavy, longer, and painful since the second dose; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0161) via an unspecified route of administration in right arm on 30Apr2021 at 18:00 as dose 2 single (at the age of49-year-old) for COVID-19 immunization. Medical history included ADHD (Attention deficit hyperactivity disorder), Anxiety, allergic to sulfa drugs. Concomitant medications included citalopram 20 mg, methylphenidate ER 50 mg. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0150) via an unspecified route of administration in right arm on 09Apr2021 at 06:30 PM as dose 1 single (at the age of 49-year-old) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient had no covid prior vaccination. Facility type vaccine at Pharmacy or Drug Store. On 10May2021 at 19:00, patient experienced her periods had become increasingly heavy, longer, and painful since the second dose. Each month the symptoms increase. This month the cramps were extremely painful, erratic, and she was bleeding through super tampons every 2-3 hours. The clots were thick and heavy. This was not normal and she have not had this severe bleeding since I gave birth to my kids. No treatment was received for the adverse events. Patient had not covid tested post vaccination. The outcome of the events was unknown.

anaphylaxis; throat swelling; This is a spontaneous report from a contactable physician. A 50-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history included hypertension, lipids (as reported) and asthma. The patient was known allergies: codeine, iodine, shellfish, latex, and cefatrizine propyleneglycolate (CEFTIN). Prior to vaccination, the patient was 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 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in hospital. The patient experienced anaphylaxis and throat swelling on 22Dec2020 with outcome of recovered in Dec2020. The events were reported as non-serious. The events resulted in Emergency room/department or urgent care. Treatment of epinephrine, steroids, antihistamines, observation was received for the events. Information on lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis and throat swelling cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of allergies to multiple materials may put the patient at high risk of anaphylactic reactions. 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.

We (myself and 2 other pharmacists) were conducting a COVID-19 vaccine clinic. The patient is on staff at the clinic and came in for her 1st dose of the Pfizer/BioNTech COVID vaccine. 10 minutes post-vaccination, patient started experiencing SOB, tingling fingers and face, and swelling of her lips and tongue. She moved herself outside to cooler air and then sent someone back inside to ask us for help. I ran outside with an EpiPen and immediately noted her pulse of 158 on her watch and she appeared to be experiencing an anaphylactic reaction. Patient stated she did not want to use the EpiPen but wanted to try chewing Benadryl instead first. I asked the staff for a blood pressure monitor and pulse oximeter. The 1st readings, approximately 12 minutes after vaccination, were HR 158, BP 155/105, and pulse ox 97%. Patient stated the Benadryl was working and her swelling was decreasing. The patient was not having trouble breathing at the time. I continued monitoring vitals and talking with the patient and approximately 20 minutes post-vaccination, she was improving (BP down to 134/80 and HR 120) but agreed we should call 911. She decided she wanted to move inside and lie down. I escorted her with support to a bed. Her vitals then increased again to BP 152/95 and HR 133 and her lips and tongue started swelling again. The patient appeared to be more labored in breathing then but still refused the EpiPen. Roughly 5 minutes after lying down, the medics showed up and took over and I went back to the vaccination area. I learned later that the patient refused to go to the hospital and after more observation was eventually allowed to leave with a friend/coworker driving her home.

Had fever, chills, vomiting, diarrhea fatigue starting 12/22 fever stop 12/23 other symptoms stayed until 12/26. 12/27 started with fever again symptoms came back and was tested12/28 and 12/29, 12/29 was negative 12/28 was positive 1/12 pneumonia

Pt received vaccine and developed HA with left hemianopsia, left upper ext and left lower ext weakness. Stroke Code activated at clinic where she works CT head neg TPA administered, transferred to ED for CTA and stroke care CTA neg MRI pending but clinically improved

Systemic: Anaphylaxis-Severe, Systemic: Seizure-Medium, Systemic: Tingling, tremors, convulsions, numbness and difficulty breathing -Medium

Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache that would not be relieved with tylenol. I took a plane and arrived at 1130 pm. I went to bed shortly after arriving at my daughters house. Friday morning, I was unable to be woken up and my daughter called 911. I was in a coma. I suffered cardiac arrest during a CT to check for clots. I was resuscitated and put on life support. CT scan for clots, strokes, heart attacks were all clear. I was admitted to the C-ICU and on life support, on the ventilator, and was on 3 different medications at max dosage to keep my blood pressure barely surviving. The doctors told my daughter not to expect me to survive because they had no idea why I was suddenly so ill. A doctor then told my daughter that my kidneys were failing, and my liver was damaged. I also developed a high fever and had a high white blood cell count. They gave me Vancomycin and another antibiotic, and then the next the day a kidney doctor gave me lasix to flush out all of the excess fluid. I woke up on Saturday not knowing what had happened and was completely terrified and confused. My daughter was allowed into the ICU to see me and keep me calm, thankfully. She explained to me what happened. I am still in the hospital, as they are keeping me for observation and trying to determine if my kidneys will start working properly again. Prior to this, I have only ever had a kidney infection, and I thought before I might have had the start of a UTI. I do have chronic high blood pressure as well, a long term side effect from open heart surgery 10 years prior for an aneurysm, but aside from that I am relatively healthy 50 year old.

According to facility representative on 1/27/2021 at approximately 7:15 am, pt was discovered not breathing with no pulse. Resident was pronounced dead at 7:44 am on 1/27/2021. Resident was previously tested positive for COVID-19 on 12/9/2020.

Patient with past medical history significant for anaphylaxis 2 months ago to iron infusion, received PCP clearance to receive COVID-19 vaccine. Patient given Pfizer vaccine # 1 (lot # EN6201). Approximately 12 minutes into 30 minute wait she began to report that she had a "sore/scratchy" throat and took Benadryl 50 mg PO (patients own supply). Patient took medication on her own and was given permission to take by NP. Patient was assessed by NP with breath sounds CTAB, no wheezing or stridor. No visible swelling of the lips, tongue or face. No rash. VS: B/P 124/73, HR 110, SaO2 100% on RA. During assessment she began to clear her throat and therefore was taken to Facility for further evaluation and monitoring. At Facility, pt was monitored for about 30 minutes. Pt admitted to be anxious about the vaccine. Pt received no medications from Facility. Pt instructed to use diphenhydramine Q6-8 hrs PRN. Pt was discharged to home.

Pt got vaccine 12/23/2020- then herpes zoster 1/7/2021 so started Valtrex. Started bleeding 1/10/21 and was admitted with platelet count of zero 1/11/2021. Diagnosed with ITP and is responding to prednisone. Also got IVIG. Of note- her dad has a h/o ITP as well and was on Rituxan and also developed low platelet count with each of his COVID vaccines.

blood clot; This is a spontaneous report from a contactable consumer. A 6-decade-old female patient (in her 50's) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose as vaccine. Medical history and concomitant medications were not reported. It was noted that one of the reporter's co-worker developed a blood clot after receiving the first dose of the Pfizer vaccine on an unspecified date. Any information or data on someone developing blood clots? The outcome of the event was unknown. Information on the lot/batch number has been requested.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium

Thirty minutes after vaccination I went into anaphylactic shock. I kept clearing my throat and my chest felt really tight. I was really winded and the chest tightness got worse and my throat was closing. I was rushed to the ER and given IV Benadryl and Steroids with Oxygen and I was discharged after 3 hours. I was able to control it for the next few days with Benadryl. I still felt short of breath for the first three days and I still have headaches and since that event. I did not have any previous allergies before this event and had had the first dose of the vaccine.

I was transported by ambulance and admitted to the hospital with numerous blood clots in my lungs after I could not breathe.; I was transported by ambulance and admitted to the hospital with numerous blood clots in my lungs after I could not breathe.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) on 30Jan2021 09:00 (age at vaccination was 50-year-old) on left arm for COVID-19 immunisation. Medical history included hypothyroidism. No Known allergies. Concomitant medications in two weeks included thyroid (ARMOUR THYROID), ethinylestradiol, levonorgestrel (SEASONALE) and cetirizine hydrochloride (ZYRTEC). No other vaccine in four weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) on 07Jan2021 14: 15 (age at vaccination was 50-year-old) on left arm for covid-19 immunization. Facility type vaccine was Hospital. She was transported by ambulance and admitted to the hospital with numerous blood clots in her lungs after she could not breathe on 22Feb2021 09:45 AM. AE resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Treatment received as Angioplasty to remove bigger clots. No covid prior vaccination. Nasal Swab test (PCR) on 22Feb2021 was negative. The outcome of the events was recovering.

10 days after my second shot of the Covid vaccine, I was short of breath and my heart rate was elevated. I went to the hospital and they found blood clots in both lungs and I had to be hospitalized.

Pt received second dose of COVID vaccine at hospital on 2/19 (date given by pt). Pt had been more sedentary than usual due to winter season. As weather warmed and pt became more active, she began to experience symptoms of left lower extremity DVT on 3/15. Pt evaluated at urgent care on 3/19 and was sent to medical center for follow up. Lower extremity dopplers were negative for DVT. Pt presented to orthopedic surgeon for follow up because symptoms not resolved and was placed on Medrol Dosepak for possible issues related to remote hip replacement. When symptoms progressed, pt presented to hospital on 3/24. 3/24 lower extremity dopplers revealed thrombus in left leg that extended into saphenofemoral junction. Patient was then transferred to hospital for L iliac venous EKOS catheter placement for catheter-directed thrombolysis with alteplase on 3/25. Pt underwent second procedure on 3/26 where Angiojet thrombectomy and venoplasty of left external iliac, common femoral and femoral vein was performed.

Patient received COVID Pfizer vaccine at approximately 0955 and reported back to unit. Medical was called to unit at approximately 1030. Upon arrival to unit patient was laying down on floor and stated she felt hot and achy all over. Patient's vitals in unit: bp 156/126, hr 135, R 22, 02 sat 98% on room air. Patient has strong history of anxiety. Patient brought to medical for further evaluation: Face/chest flushed, hyperventilation, tachycardia, skin diaphoresis/clammy. No skin hives. No wheezing. No vomiting/diarrhea No swelling lips/face. 02 @ 2 L given, blood sugar 126, last bp 129/77-hr 109 EPIPEN given via R thigh, EKG shows sinus tachycardia, possible inferior infarct, Abnormal ECG. Will send pt to local ED. *Report from ED received: indeterminate troponin and elevated WBC count, also with elevated BUN and creatinine. Pt will likely be held overnight for observation for suspected cardiac issues. Vaccine reaction not suspected at this time.

Pt developed symptoms of anaphylaxis. Two doses of IM epinephrine were administered. 911 was called. The patient was taken to the hospital via ambulance.

blood clots in arm/Blood Clots in Left Arm; swollen lymph nodes /Swollen Lymph Nodes in Left Arm; nodules were found on her lungs/Nodules in Lungs; arm swelling /Left Arm Swelling; Left Arm Redness; Left Arm Discomfort; Soreness at the Injection Site; This is a spontaneous report from a contactable consumer (Patient's Mother) calling on behalf of daughter. A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and expiration date unknown), via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:30 at age of 50 years old at single dose for covid-19 immunisation. There was no medical history. There were no concomitant medications. The patient did not have prior vaccinations within 4 weeks. No adverse events following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. The patient experienced the following after first dose. The patient experienced arm swelling /left arm swelling (hospitalization) on 09Mar2021 with outcome of recovering , blood clots in arm/blood clots in left arm (hospitalization) on 11Mar2021 with outcome of not recovered , swollen lymph nodes /swollen lymph nodes in left arm (hospitalization) on 11Mar2021 with outcome of not recovered , nodules were found on her lungs/nodules in lungs (hospitalization) on 11Mar2021 with outcome of unknown , soreness at the injection site on 05Mar2021 with outcome of not recovered , left arm discomfort on 08Mar2021 with outcome of not recovered , left arm redness on 09Mar2021 with outcome of not recovered. The patient was hospitalized from 11Mar2021 to 12Mar2021. On 05Mar2021 she began to have arm pain. 48 hours later, patient's arm started really hurting her, something about her arm being sore on the day of injection and reporter said she was going to be sore and when she got back from going away for the weekend, she thought uh oh, there was a problem here, this was not normal, not right. On 10Mar2021, she experienced swells arm swelling and went to urgent care which was diagnosed with swollen lymph nodes and given Cheplex prescription at urgent care. 11Mar2021, daughter was admitted to hospital by her provider. Daughter was found to have blood clots in arm and continued swollen lymph nodes. Daughter was given IV cheplex and Eliquis while in hospital. Daughter will have to be on Eliquis for next 3 months per reporter. The patient had her first vaccine, Pfizer, and became ill with blood clots, swollen lymph nodes, and wound up in the hospital. Reporter stated that she and the patient were worried about her getting the second shot. The patient was on blood thinners and was seeing a pulmonary doctor and hematologist. She didn't know about her getting the second shot and thought this should be reported. The patient was due for the second vaccine next week on 26Mar2021 and she was still sick, should it be postponed or what? The patient went the night before the hospitalization to the Urgent Care and the doctor prescribed Keflex, an antibiotic and saw her primary care doctor the next morning and she put her in the hospital. Reporter stated they were getting nervous and wanted to report for side effects. She stated the patient was home from the hospital but still sick really bad. The patient went to Urgent Care 10Mar2021, saw her primary care 11Mar2021 and was sent to the hospital 11Mar2021. Reporter later clarified that the patient was sent to the Emergency Room and after a few hours, she was sent upstairs to be admitted for a 24 hour hospital stay. The patient received Eliquis; Keflex as treatment. Fluids at the hospital, unknown type. Reporter stated they decided the patient wasn't doing really well and went to the Urgent Care that night and were given Keflex because they felt there was an infection. When they discovered it further that there were blood clots, the patient was told to stay on the antibiotic and given fluids and put on blood thinner, Eliquis, states patient had never been on a blood thinner before. Patient was admitted on 11Mar2021 for 24 hours. Reporter stated that they kept the medicine going and then felt she was stable enough to be discharged the next night at around 18:00 to continue with Keflex antibiotic and Eliquis for 3 months. Reporter stated they were told to contact a hematologist and pulmonary doctor for the nodules in her lungs and to contact her primary doctor if not doing better in one week, but they will probably contact her tomorrow. Reporter clarified that the patient had a chest x-ray a couple of months ago and everything appeared fine, so she thinks that the nodules developed after the vaccine. The patient had a chest x-ray on 11Mar2021 and nodules were found on her lungs, scheduled to follow up with lung doctor. Reporter stated whether they were there before or not was unknown. No follow up X ray yet. Reporter would like to know if daughter should get second dose? Second dose was scheduled 26Mar2021. Adverse events required visit to emergency room: Urgent Care the night before, follow up the next morning with primary doctor, the doctor got her in right away and said she needs to go to the hospital. Yes, patient went through the ER, doctor said that she would be coming and then after there a while, she was admitted to the hospital. Adverse events required visit to physician office. Patient saw the doctor on 11Mar2021 and was sent to the hospital. Information about lot/batch has been requested.

Systemic: Unknown, patient found deceased at home evening after receiving vaccine.-Severe, Additional Details: called pharmacy inquiring about vaccine for patient. She received her COVID vaccine on 4/6/21 and later that evening was found at home deceased. Called to gather information on the patient/vaccine. Caregiver stated that the patient did not have a PCP, therefore they do not have much medical history on her. There were no notes on adverse reaction during post-vaccine observation. It is unknown at this time if vaccine played any role.

pt recieved vaccine at 1135 on 4/9, pt reported tongue swelling around 1130 the next day (4/10, 24 hrs after), presented to ED via EMS 1518, was diagnosed with angioedema likley due to ramipril, was intubated by 1624. pt had difficult intubation, was transferred to ICU, in critical condition on a ventilator, days later, after multiple cardiac arrests and multiple rounds of ACLS were performed, the pt was pronounced dead at 0127 on 4/12

The patient is a 50 year old female with no medical problems who developed sudden severe headache on 3/24 accompanied by nausea and vomiting. She presented to urgent care on 3/25 and was considered to be dehydrated and given IV fluids. On 3/27 she developed left hand weakness. On 3/29 she revisited urgent care with residual symptoms plus hand weakness and was sent to hospital where she was admitted and MRV demonstrated Cerebral Venous Sinus Thrombosis of the sagittal sinus, right transverse sinus, and right sigmoid sinus. The left transverse sinus may also be occluded or congenitally absent. There was no evidence of hemorrhage or stroke. The patient was admitted and started on heparin then transitioned to Eliquis and discharged. On 4/3, she had worsening of symptoms consisting of dysarthria, left facial, and worse left arm and hand weakness. She was readmitted to hospital then transferred to hospital for further management.

50 yo female with no medical history known to our system presents with Inferior STEMI with ventricular fibrillation cardiac arrest. Unknown initial downtime without CPR. Arrived by rescue squad and taken emergently to Cardiac Catheterization Lab, required mid-LAD stenting. Therapeutic temperature management (TTM), now rewarmed. Currently intubated on mechanical ventilation, on norepinephrine, poor neurological responses, consider neurology consult for brain evaluation/prognostic recommendations. There is a progress note written by ED RN on 4/12/21 that states family reports she had "her 2nd COVID shot 1 week ago," but per Immunization Registry, only 1 COVID vaccine is recorded.

DVT in right leg; chest pain; PE in right lung was found on CT scan; numbness in both legs; Back pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in arm left on 18Mar2021 13:30 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included breast cancer, hypothyroidism, diabetes. The patient did not have covid prior vaccination and no covid tested post vaccination. No known allergies. The patient was not pregnant. Concomitant medications in two weeks included metformin; atorvastatin (LIPITOR); levothyroxine sodium (SYNTHROID), vit d, multivitamin. No other vaccine in four weeks. Back pain started on 20Mar2021, chest and back pain on 24Mar2021 and chest pain continued until she went to the ER on 27Mar2021. When PE in right lung was found on CT scan on 23Mar2021 12:00 PM. The patient was hospitalized on 27Mar2021 and heparin was started and continued until 29Mar2021 when she was released. The DVT in right leg was found on 28Mar2021 with ultrasound after she mentioned numbness in both legs on 23Mar2021 12:00 PM. She started apixaban (ELIQUIS) on 29Mar2021 before leaving the hospital and still taking it now. She went to follow up appointment with hematologist that suggested that she remained on apixaban and return in 10 weeks for another checkup. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Number of days hospitalisation was 3. Treatment received for events included heparin and apixaban. The outcome of events was recovering. The patient received second dose of BNT162B2 in arm left on 09Apr2021 12:30 (Lot Number: EK8727).

Patient received her 1st dose of Pfizer COVID vaccine on 02/26/2021. She noted some wheezing and slight shortness of breath and shared this information with her PCP at her regularly scheduled visit on 03/01/2021. PCP refilled inhaler at that time. Her shortness of breath progressively worsened, and she was seen by another provider as a walk-in at the office of her PCP on 03/13/2021. At that time, she was prescribed prednisone for 5 days, noting some improvement after a few days. She received her 2nd Pfizer COVID vaccine on 03/19/2021. The patient woke up on the morning of 03/20/21 with a swollen and painful leg and by 03/22/21 called PCP and was seen in the office. PCP ordered D-Dimer and LE ultrasound. Per the patient, the D-dimer was abnormal and the LE U/S showed a blood clot. PCP sent the patient to the ER, where a chest CT was ordered and showed a pulmonary emobolus. She was admitted overnight and started on Eliquis, and discharged the next day after seeing a hematologist.

Right leg popliteal DVT. Symptoms began approximately 3/28/21 (14 days after receiving vaccine), and patient presented to clinic for diagnosis 4/14/21.

4/16/21 Second Dose received. 4/17 and 4/18 noticed light swelling in ankles. No other effects. 4/19 - Emailed my Cardiologist about swollen ankles. Didn?t think about the vaccine as a potential cause. He scheduled an Echocardiogram for May. 4/20 to 4/22 - Edema is ankles and lower legs with pain on bottom left. Tried heat and elevation with no relief. 4/23 - Called Advice Nurse with recommendation to go to ER. ER determined a blood clot in left leg at the left posterior tibial vein measured at 6.3cm.

On April 23,2021 patient was at her home and started complaining of shortness of breath and chest pain. She called 911 and they responded to her residence at 0500 a.m. While being assessed, patient collapsed. She was asystolic. CPR was started but to no avail. She was transported to the coroner's office where an autopsy was performed. She had bilateral pulmonary thromboemboli. There were not deep vein thromboses found in her legs.

on April 2 nd i had to go to family walk in clinic over chest pains and contractions. The clinic ran vitals with EKG letting me know a ambulance had to be called cause i was having a heart attack. I was not aloud to leave . In the ambulance i was giving Asprin ,Nitros and a blood clot remover with high blood pressure meds. Takin to hospital.

15cm Blood clot in left leg - lower calf.; Superficial vein prominence; This is a spontaneous report from a contactable consumer (patient herself). This 50-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER8732), via an unknown route in the left arm, on 27Mar2021 at 14:45 (at the age of 50-year-old) at single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included Factor V Leiden and varicose veins. The patient did not have allergies. The patient did not have COVID-19 before vaccination. Relevant concomitant medications included acetylsalicylic acid (ASPIRIN), levothyroxine sodium and Women's multivitamin (unspecified). On 07Apr2021, the patient presented 15 cm blood clot in the left leg-lower calf and superficial vein prominence. The events required a physician office visit. An ultrasound was done but results were not provided. Therapeutic measures taken as result of the events included enoxaparin sodium (LOVENOX) injections for 14 days. Post-vaccination COVID test was not performed. The patient was recovering from the events.

Anaphylaxis. 36 hours after 2nd vaccination. Closing of of chest muscles, lungs, esophageal tract up to back of throat. Resting heart rate of 133 BPM at triage in ER. Severe coughing which caused vomiting. Slight pink flushing of nose and cheekbones 30 minutes after shot, after leaving vaccination site, with no adverse reaction.

Anaphylactic reaction; This is a spontaneous report from a contactable consumer (patient). A 50 -Year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER87306), via an unspecified route of administration, administered in left arm on 25Mar2021 at 21:27 (at the age of 50 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 the patient experienced Anaphylactic reaction. The patient visited emergency room on 25Mar2021 and and was released from the emergency room on 26Mar2021. The patient received treatment for the events. Caller stated from her understanding from her doctor she was not anaphylactic to anything in the shot but she had an anaphylactic reaction. Caller stated she wanted know since the vaccine is federally regulated and mandated and she has health insurance but her (Services name) and deductible is high and her being anaphylactic to the shot and receiving care and now receiving bills does Pfizer offer any help with that. Anaphylactic reaction: Caller stated this ended the next morning because it was overnight when she was released from the hospital. Caller clarified she was brought to the emergency room and was released from the emergency room. Treatment: Caller stated she was provided medication at the site of the (Name) and then put in an ambulance and was given medication then transported to the hospital. Caller stated the COVID vaccine she received was the first dose and last dose. Caller stated the physician office was not open and the hospital she wanted to go to was approximately 30 minutes away and she was transported to the nearest hospital to the facility location. The patient did not undergo any lab tests and procedures. The outcome of the events was recovered on 26Mar2021.

A Blood clot was found; Cellulitis; Migraine started within 24 hours; left calf pain/Leg increased in swelling and burning pain; severe swelling and burning sensation; severe swelling and burning sensation; Leg increased in swelling and burning pain; Phlebitis; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199/EN5318), via an unspecified route of administration administered in left arm at doctor's office/urgent care facility on 12Mar2021 15:00 as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not COVID tested post vaccination. The patient had no other vaccines in four weeks. Medical history included high blood pressure and sleep apnea. Concomitant medications included amoxicillin, valsartan, amlodipine, and vitamin d [vitamin d nos]. The patient previously took doxycycline and experienced allergies. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. On 05Apr2021 at 03:00 PM, the patient experienced a blood clot was found, cellulitis, migraine started within 24 hours, left calf pain/leg increased in swelling and burning pain, severe swelling and burning sensation, leg increased in swelling and burning pain, and phlebitis. It was further reported that migraine started within 24 hours. 48 hour left calf pain that got increasingly worse leading to a severe swelling and burning sensation. The patient went to right time urgent care on Friday, 09Apr2021. The patient was diagnosed with cellulitis. It was also reported that pain increased swelling spread and went to emergency room (ER) on 10Apr2021 for ultrasound of leg. No clots and was advised if worsened to come back. The patient's leg increased in swelling and burning pain. The patient went to urgent care patient first on 11Apr2021 and then the doctor on Monday, 12Apr2021 where she was sent for a STAT ultrasound due to major pain and swelling. A blood clot was found. Phlebitis was diagnosis. The patient was sent to a vascular surgeon on 13Apr2021 and vein specialist on 15Apr2021. The patient was given Xarelto blood thinners and started taking them on 15Apr2021. All of this began 48 hours after taking the second vaccination (pending clarification) and has the patient worried. The events resulted to doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of all events. The patient had not yet recovered from all events.

heart attack; tingling down left arm/tingling down right arm /tingling down left leg/tingling across back/tingling down right leg; burning sensation in her shoulder blade; muscle pain; muscle tightening; aching to left shoulder; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number FR8732, on 05Apr2021 at single dose in left arm for COVID-19 immunisation. Medical history included blood clot in lung from 26Mar2021 (according to the chest X-ray she did not still have it but she had not been to her pulmonologist yet), complete hysterectomy in Jan2021, liver condition, high cholesterol and blood clot. Concomitant medications included apixaban (ELIQUIS) for blood clot, ursodiol for liver condition, and pravastatin for high cholesterol. The patient had the first dose on 05Apr2021. She began feeling muscle pain and a burning sensation in her shoulder blade the Thursday after receiving the vaccine (08Apr2021) and into Friday (09Apr2021). She had muscle tightening and aching in her left shoulder on 08Apr2021. By Monday mid morning (12Apr2021) she had tingling all down her left arm, across her back, down her right arm and into both legs. She began having tingling in her arms and legs bilaterally since last Monday (12Apr2021), however it was more prominent in her left extremities rather than the right. She wanted to know if this was a side effect of vaccine. She got the shot in her left arm. She went to the hospital and they admitted her. She had tests in the ER. She had MRIs, CTs and a battery of blood tests. They could only tell her what it was not and not what it was. It was not cancer, stroke, heart attack, aneurysm or a brain tumor. She was released and did not know what caused it. Again from the above that on Thursday (08Apr2021) her left shoulder muscle started aching and on Monday a week later she experienced tingling. She thought she was having a heart attack and was hospitalized for 4 days. She asked the doctor if this was a side effect and she was told to call the place where the vaccine was administered. She called the nurse and she could not give answers and recommended that she call Pfizer. Several conditions were ruled out but she was not given a reason for her symptoms. Her HCP has not been helpful. She stated she had a complete hysterectomy in January but doesn't think that would have any effect. She had a CT on 12Apr2021, a MRI of her head and neck on 12Apr2021, a MRI with contrast on 14Apr2021 of her upper neck, a MRI of her lower back on 15Apr2021 and a bone scan on 15Apr2021. Stated that they all came back normal no abnormalities. The outcome of muscle tightening was resolving. The outcome of heart attack was unknown. The outcome of other events was not resolved.

Pfizer-BioNTech COVID-19 Vaccine EUA: nine and eleven days after vaccination during clinic visit patient reports left axillary swelling radiating down left arm. Subsequently developed numbness and tingling to left hand/fingers seven days after vaccination. Arthralgias, joint swelling, mylagias, and weakness also noted. After first visit patient prescribed methylprednisolone. Two days later patient returned to clinic with improvement in swelling but reports tremors and three new bumps on arm, palpitations, and weakness/numbness of 4th and 5th digits on left hand proximally. Patient referred to neurology and physical therapy with diagnosis of ulnar neuropathy.

Shortness of breath, DOE, worsening daily from time of shot to now. PCP on 4/13, CXRAY 4/16, Pulmonology 4/26/21, ER 5/3/21 and admitted.

Rash at injection site with hives, anaphylaxis started. I took benadryl and topical cream and used inhaler Also have extremely runny nose, congestion and fatigue

1st Pfizer Covid vaccination on April 1, 2021 Morning of April 2 she woke up with severe lower extremity spasticity and the inability to mobilize. Presented to hospital April 3rd. Started high-dose intravenous Solu-Medrol on hospital day 3 and it was not until hospital day 4 that we begin to see improvement of her spasticity and ability to move her legs Felt to be acute myositis, most likely an immune mediated post vaccination event Received 1000 mg IV Solu-Medrol x5 days Course complicated by bilateral pulmonary embolisms in setting of severe spasticity and immobility Hospitalized 4/3/21-4/13/21 Discharged to rehab, on day of discharge requiring maximal assist to stand and for transfers

anaphylactic response, lasted 5 to 10 minutes only: very sudden/rapid onset of full-body vasodilation, heart palpitations, chest tightening/difficulty breathing

headache, high pulse rate, light headed, feeling like shes going to pass out, faint, stroke on and off for 3 weeks

Anaphylactic reaction. treatment with EpiPen. patient treated with own EpiPen. EMT called and was retreated with EpiPen. Also given Benadryl by RPh on duty. given IM Benadryl by EMT. Throat swelled up and pt has trouble breathing

Vaccinated for COVID-19 with Pfizer on 3/11/2021 and 4/16/2021, tested positive for Covid-19 by PCR on 5/12/2021. Entered emergency department with complaints of knee pain on 5/14/2021 (knee aspiration done 5/12/2021). Also noted to have Covid-19 pneumonia and hypoxemic respiratory failure and was admitted to hospital.

Minor allergic reaction; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; Swollen, tingling, and numb tougue and lips.; sore arm; This is a spontaneous report from a contactable consumer (the patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW0151), dose 1, single dose via an unspecified route of administration, administered in arm left on 14Apr2021 for covid-19 immunization. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Past drug event included allergy to ampicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced minor allergic reaction, swollen, tingling, and numb tougue and lips and sore arm on 14Apr2021. Therapeutic measures taken as a result of minor allergic reaction, swollen, tingling, and numb tougue and lips. and sore arm included diphenhydramine (BENADRYL). The outcome of minor allergic reaction, swollen, tingling, and numb tongue and lips, sore arm was recovered with sequelae. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the known safety profile, a possible contributory role of BNT162B2 to the development of minor allergic reaction cannot be excluded.

Patient is a 50 year old female with history significant for autism, developmental disability, hypertension, seizures, frequent falls, Tourette syndrome, s/p CVA. She presented 3/31/2021, through the Emergency Department from home with following an unwitnessed fall. She was found by her mother this evening on the floor at the bottom of a flight of stairs. She was last seen by her mother sometime in the morning. Patient not capable of providing history as verbalizations are limited at baseline to occasional single word expressions of needs. Patient was noted in the ED to have multiple bruises to her head, arms and legs in various stages of healing. Patient lives with her mother who is also her legal guardian. Mother was poor historian in the ED and was unable to help determine how long patient was on the floor. Patient's mother verbalized to ED provider that she is not able to supervise the patient at all times due to her own medical needs. ED provider noted that upon leaving the ED the patient's mother stated to staff that they should put the patient out of her misery. County Crisis Center was contacted by ED staff and a referral was made to Adult Protective Services. Patient does not answer review of systems questions when asked. Admit date: 3/30/2021 Discharge date: 4/5/2021 Primary diagnoses: Principal Problem: Severe sepsis, unknown origin, without end organ failure o Resolving, no fever o Vancomycin stopped. o Wbc improving, fever resolved o Blood cultures still negative o After 4days of IV antibiotics she was transitioned to oral augmentin whenDcing flagyl. o PCP to follow fever curve, white count... CT chest abdomen and pelvis negative at admission Blood cultures have remained negative Active Problems: Benign essential HTN Developmental disability Residual autistic disorder Fall o Most recent fall 03/30/2021, unwitnessed, possibly down unknown number of stairs o Followed by Neurology, for frequent falls, EEG on 01/18/2021 abnormal with focal epileptic seizures suspected, she has been started on Lamictal taper o Continue Lamictal as prior to admission Rhabdomyolysis o Due to Unwitnessed fall and immobile on floor for unknown number of hours on 03/30/2021 o CPK trending down. Kidney function has remained normal with ongoing IV infusion Hyponatremia Elevated troponin I level Cardiology, Dr. consulted from the ED, elevated troponin suspected to be secondary to rhabdomyolysis o Troponin 1.58 upon arrival, peaked at 1.88 and declining is subsequently o EKG demonstrates sinus tachycardia with 1st degree AV block and RBBB, rate 101, QTc 487 Echo was normal at 60% ejection fraction Closed anterior dislocation of right glenohumeral joint was reduced in the emergency department which will explain the large bruise over her right shoulder right shoulder active and passive range of motion intact Hypomagnesemia

RECENT TIA AND OPEN HEART SURGERY AND THYROIDECTOMY, FEEL PRESSURE IN HER CHEST, BP 96/69, HR 63, EMS CAME, EKG LOOKS LIKE AFIB. TRANSPORTED TO HOSPITAL.

Multiple seizures, went to ER, lost complete memory for 18 hours, 3 day hospital stay, loss of driving privileges for 90 days, on Keppra for seizures and on Eliqios for blood clot near the lung.

bleeding from scratching the itching rash of the allergic reaction.; Allergic reaction; night itching; itching rash/rash all over her body; Pain in her arm and ankles; Pain in her arm and ankles/ pain in her ankles, on the bottom part of her legs around her ankles, very bad pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in left arm at age of 50-years, on 15Apr2021 15:00 (Lot Number: CW0151) as single dose; then second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration and administered in right arm at age of 50-years, on 07May2021 (at 12:30-12:40) (Lot Number: EW0167) as single dose for covid-19 immunisation. Medical history included allergy to shellfish. The patient's concomitant medications were not reported. There was no other vaccines administered on same date with the Pfizer vaccine. There was no any other vaccinations within four weeks before or after the Pfizer Corona Vaccine. The patient previously took benadryl and experienced allergy (Doctor told her never to take Benadryl because she could die, could have anaphylaxis). The patient administered both doses of the Pfizer Corona Vaccine. She believed she was having a very bad adverse effect from the vaccine, an allergic reaction. She also reported having had pain in her arm and ankles the day of her second dose of Pfizer Corona Vaccine. Onset 2 days after the Pfizer Corona Vaccine, unable to clarify date further or if after the first or second dose of the Pfizer Corona Vaccine. She ate a lot of fruits and vegetables, she had been practically a vegetarian for a long time. Allergic reaction started little by little when she would eat; but now it occurred every time she ate. Usually she ate in the late afternoon so now when she ate a lot of fruits and vegetables she spent the rest of the night itching; she was tearing into her skin now, bleeding from scratching the itching rash of the allergic reaction. Ever since she had taken the Pfizer Corona Vaccine, every times she ate a lot of fruits and vegetables she seemed to be getting this rash all over her body that won't go away. It was scary, she was scratching and itching, starting to get worried because she was bleeding everywhere. She was afraid she may eat and get anaphylaxis. The patient had Hydroxyzine and asked if she can take Hydroxyzine for the allergic reaction. She wondered if her allergy to Benadryl could be part of the allergic reaction she was having. She had always had an allergic reaction to Benadryl which made her very nervous. She had to just flush herself, drink a lot of water to flush her system. About events Pain in arm and ankles: Time of onset unknown. Onset the first day (on 07May2021) when she took the second dose of Pfizer Corona Vaccine. She had very bad pain in her arm, could barely lift her arm, and also had pain in her ankles, on the bottom part of her legs around her ankles, very bad pain. The outcome of event Pain in arm and ankles was recovered completely by the following evening on 08May2021, of event allergic reaction was not recovered, while for remains events was unknown. No follow-up attempts needed. No further information expected.

Wednesday, May 19, 2021 1st COVID-19 vaccination shot Summary: Wednesday, May 19, 2021 received my 1st COVID-19 vaccination shot. My body tried to reject it. I threw up 5 times. Ensued many unwanted side effects. I don?t think it would be good to get the 2nd vaccine dose. Given I am not fully vaccinated, I need an alternative solution to prevent being infected with the virus. Help!!!! Please Help!!! Bad Side Effects: Stuffy Nose Congested Nose Headaches Vomiting Nauseous Upset Stomach Unsettled Stomach Unusual Perspiration Pain in Left Arm Abnormal Period Menstrual Blood Clots Shoulder Pain/Tension Upper Back Pain/Tension Chest Pain/Tension Shooting Pain in Chest Heart Palpitations? Numbness Runny Nose Sneezing Profusely Allergies? Hoarse Voice Winded Dry Mouth Existing Worsened: Cold Sores Stomach Noises Snoring? Foot Numbness Ear Ringing Eye Floaters Joints Popping Sound Other Observations: Stomach Bloated Increased Flatulence Pseudo Conclusion: Given my body?s adverse reaction I don?t think it is wise to get the 2nd shot. It is obvious my body does not like it. I am disappointed because I really did not plan to get vaccinated; however, I felt I had no other option when the government made the announcement. When the government announced No masks for those vaccinated, I know there would be some NOT vaccinated & NOT wearing a mask thus putting me at risk. I am okay with wearing a mask for another year or even for the next 5 years. The doctors have said me wearing a mask is protecting others not necessarily myself. I concluded even if I continue to wear a mask there would be others (NO mask & NOT vaccinated) not following the rules potentially exposing me to the virus. Hence the only way to protect myself is to get vaccinated. The vaccine appears to have affected so many areas of my body. I regret getting the 1st shot, I want to remove every trace of it from my anatomy. Please let me know if it is possible to rid the vaccine along with all the bad side effects from my body. I do not want to subject my body to anymore of this vaccine; however, I still need a reliable solution to avoid being infected with the virus. I don?t know what to do. Details: Wednesday, May 19, 2021, I received my 1st COVID-19 vaccination shot around 3:30pm. The medical staff had all those being vaccinated to sit for at least 15 minutes for observation to be monitored. I stayed for monitoring for close to an hour (wearing my masks). I felt fine, I noticed my right nostril felt stuffy, congested with a slight burn sensation. I noticed a slight headache when I left. I had about 3 errands to do. 2 hours later I wasn?t feeling well. In addition to a stronger headache my stomach felt queasy. Around 6:30pm I had to pullover to vomit; I threw off my mask and threw up once and then a 2nd time. I sat in my car taking deep breaths until I felt I could make it home. I make it home around 7pm in time to throw up 3 more times, for a total of 5 times. The vomit tasted acidic, sour, citrusy, and metallic at times, and salty. I was only throwing up the vaccine it was mostly clear with white alka seltzer looking deposits. I last ate some crackers around 12 noon. Vomiting is NOT normal for me. I can?t remember the last time I threw up, many many many years ago. l had a headache, queazy stomach, and was exhausted; about 7:30pm tried to sleep. I got up around 10:30pm ate a few saltines and drank a little water but I still didn?t feel good so I didn?t eat anything else. Rough night trying to sleep, tossing and turning. Next day (Thursday day 2) I felt slightly better, not comfortable enough for real food so I drank plenty of water in small amounts and ate saltines; headache subsided. I also had more than usual underarm perspiration with a strong unfamiliar odor. Wednesday, May 19, 2021 1st COVID-19 vaccination shot It appears the vaccine affected my menstrual cycle. My period usually lasts for 3-5 days max, usually light blood flow on days 4 and 5. It was a normal light day 5 when I received the vaccine. After the vaccine, I began having heavy blood flow. The heavy blood flow is accompanied by blood clots. In the past I?ve had a blood clot here and there but not like this. Menstrual blood clots for 9 days after being vaccinated. This is NOT normal for my body. My period was 14 days. Prior to being vaccinated, I NEVER had a period last this long. To my surprise the vaccine affected my female organs. I am right handed, so the nurse recommended using my left arm for vaccination. Left arm where vaccine injected was very sore. Arm pain subsided after 3 days. Pain soreness tension primarily on my left side, shoulder, upper back, chest area. There is a shooting pain on left shoulder, down back to breast, chest heart area; pain comes and goes. Heart palpitations? Experienced this for over a week about 10 days. Numbness in left hand when I sleep on my left side, wake with my left hand numb. Numbness in both hands when I try to sleep on my back. Numbness in my feet after standing for about 15 minutes. Numbness in my leg and buttocks, primarily left side after sitting for an extended period of time. Before being vaccinated I only experienced numbness in my right foot after being on my feet for an extended period of over 4 hours. Last year my right foot/heel would began to hurt after being on my feet for an extended period of time (> 4 hours). Then there would be pins and needles sensation. The solution would be to rest and elevate my feet. I also replaced my shoes (proper support). Post vaccination even before the time my feet would hurt now my right foot goes numb within 30 minutes of standing even while wearing supportive shoes. My left butt cheek goes numb when I am sitting with my legs elevated; this was my most comfortable position pre-vaccination. Since the vaccine my stomach feels upset or unsettled especially in the morning. I am also noticing bloating and more gas than usual. My stomach is also excessively more noisy. Before the vaccine my stomach would make noises when I was hungry or hadn?t eaten, but now there are so many stomach noises almost nonstop all day and night long all the time My nose is feeling congested with a slight burn sensation since getting the vaccination. Immediately after getting the shot my right nostril felt stuffy, congested with a slight burn sensation. This congested feeling comes and goes, especially noticeable when wearing a mask. Prior to being vaccinated I had not experience this issue even as I have worn multiple masks for over a year with NO stuffy nose. Saturday, May 29, 2021 (day 10 post vaccination) I get cold symptoms; runny nose and sneezing. I haven?t had a cold in years; I don?t really get colds; if so the symptoms are mild and quickly dissipate. Now my nose has been running pretty much non-stop causing me to blow my nose just as often. I am also sneezing a lot. This is NOT normal for me. I drank plenty of liquids; however, running nose and sneezing continued leading to hoarse voice. These symptoms prevented me from sleeping. I don?t know if these are cold or allergy symptoms. I had NO allergies before the vaccine. These symptoms finally subsided after 3 or 4 days. My neighbors are waking up in the middle of the night (2am, 3am, 4am, 5am). I began to wonder if I am waking my neighbors possibly with snoring. I don?t really know, no evidence. Throat feels winded and dry when talking especially when I try to whisper. I have to drink a lot of water. Ringing in my ear started In 2019. I thought this phantom sound went away; however, post vaccination I?m hearing the ringing sound again. It seems worse than before. 2018 diagnosed with eye floaters. I am noticing floaters more since getting the vaccine. I usually see the eye floaters when going to light from dark. Post vaccination I am noticing the floaters even in dim light; not normal. I started getting Cold sores in 2006. I thought I had them somewhat under control. Since the vaccine l keep getting cold sores, this may be due to my menstruation. Recently within the past year, my shoulder and elbow joints sometimes make this popping sound when I exercise/move my arm. Post vaccination my shoulders and elbows are making the popping sound every time I move my arm. Now sometimes my knees and ankles are also making a popping .

Irregular Vaginal bleeding; Nausea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: ENG206; Expiration date were not reported), via unspecified route of administration in the left arm on 10Mar2021 03:15 PM (at the age of 50-years-old) as second dose, single dose for COVID-19 immunisation at a School or Student Health Clinic. Medical history included asthma and thyroid from an unknown date and unknown if ongoing. The patient was taking other medications in two weeks. The patient previously took Vitamin B12 (reported as B12) and experienced drug allergy. The patient was previously vaccinated with BNT162B2 (Batch/Lot Number: ENG201) in the left arm on 09Feb2021 03:15 PM as first dose, single dose for COVID-19 immunisation. Patient was also previously vaccinated with Tetanus vaccine in the left arm on 20Jan2021 as first dose for tetanus immunization and experienced Shingles. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. On 10Mar2021, the patient experienced irregular vaginal bleeding and nausea. No treatment was given as a result of the events. The outcome of the event was not recovered No follow-up attempts are possible. No further information is expected.

Blood clot in left leg. Currently on blood thinners to address it. I have no history of blood clots before this,

Patient said her arm was in a lot of pain, said there was some bleeding around the area (unclear if bleeding persisted after the patient left the pharmacy)

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Hyperventilation-Severe, Systemic: Vomiting-Mild, Additional Details: Patient received COVID vaccine. Suspected anaphylaxis and throat swelling and shortness of breath occurred within 1 minute of injection. 911 was called promptly and epipen was administered. first responder on 911 called recommended 324mg aspirin, which was also given. EMTs took patient to hospital and vitals were taken.

Congestive Heart failure diagnosed recently. Began with pain and tightness in chest that I thought was stress/anxiety within 1 week of 1st vaccine. Progressed to recent diagnosis of Ejection fraction 30. Also experienced a sharp decline in hormones and diagnosis of complications r/t Menopause.

thought she was having a stroke; Not able to walk on her own; almost fainted/about to passed out; Dizzy/felt very dizzy; Confused; Very pale; Vertigo; This is a spontaneous report from a contactable consumer (patient reported for herself). A 50-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0182, Expiration date: 02Jun2023, NDC number was unknown), via an unspecified route of administration, administered in left arm on 09Jun2021 as 1st dose, single for covid-19 immunisation. Patients had no medical history (including any illness at time of vaccination) and had no relevant family medical history. No concomitant medications were used by the patient. Patient had no prior vaccinations (within 4 weeks). Patient was going on vacation, so her daughters wanted her to get the vaccination. On an unspecified date of Jun2021, in the evening patient noticed she was dizzy. It got worse by an unspecified date of Jun2021. On unspecified date of Jun2021, patient's coworker sent her to the emergency room because they thought she was having a stroke and noticed that she was confused and very pale and about to passed out. Patient also called the nurse in charge and they also thought she was having a stroke because she was confused. Patient felt very dizzy. Patient was eating lunch and got up to get an apple and almost fainted. Patient was not hospitalized, she waited 7 hours in the emergency room and left without being seen. Patient stated it was a long wait, and a lot of people were waiting, and she asked before she left and there were still 10 people in front of her. On unspecified date of Jun2021 in morning, patient noticed that she was not able to walk on her own and she was still dizzy. On an unspecified date of Jun2021, patient went to see one of the doctors at the clinic. Doctor could not see her, but a nurse practitioner saw her and prescribed her something for vertigo. Patient stated that she was confused lately. Patient had emergency room visit and no physician office visit. No relevant tests were performed. The outcome of all the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

On left feet under knee and up swelling vain, red and hard when I touch, really painful. Looks for me like thrombosis

Pt. went to pharmacy on 6/22/21 to receive the second dose of Pfizer-BioNTech vaccine, lot number EW0177. The day after the vaccine was administered, her lower arm was swollen, red and her elbow felt hot to the touch. It was too painful to fully extend her arm. There was a white streak across the reddish purple elbow area where it appeared as though there was an infection growing. She went to her normal doctors office, she saw his nurse practitioner who took an x-ray and gave her two intravenous injections of antibiotic (unknown type). One in each buttock and prescribed an oral antibiotic: Cephalexin 500 mg., and Ibuprofen 800 mg. From that day forward she was unable to move the arm at all and the medication did not bring the swelling or the infection down. She was very tired and her arm did not lessen in pain as the days passed. On June 29, 2021 she was in her bedroom and her older daughter was in her room and believed her mother was resting. At approximately 7:20 p.m., pts. husband returned from work and came into the master bedroom turning on the television. As he did so he made joke expecting pt. to laugh or comment, when she made no response he looked over at her and saw that she was laying on the love seat at an awkward angle. He moved to her side and saw her eyes were open but unseeing and saw that her dental prosthetic was partially pushed out of place. He removed and called EMS immediately, not detecting any obvious signs of life. Her daughter came into the room and immediately started CPR. Paramedics arrived in under 2 minutes and moved pt. to the living room where they could intubate a breathing pathway and carried on with attempts to revive her heart muscle for approximately 25 minutes before Paramedic called time of death at 8:02 p.m. Paramedics departed and the Police arrived staying until the Mortuary attendants came to the home at about midnight to accept pt. body for transport to its facility. The Family is seeking an autopsy and the coroner is claiming one is not necessary. The family believes it is absolutely necessary to ascertain whether or not the second dose caused her death as it seems is likely and whether she should have been advised of her heighten risk level. Regardless of COVID 19 Emergency measures, an autopsy is necessary and the family is determined to ensure that it is conducted. Pt. has had a history of the following: Adult onset Asthma, allergic reactions in skin rashes that were significant. Hypothrodism (Graves Disease) which proved to be difficult to find the right meds to bring it under control; prone to incidents of Atrial fibrillation which have escalated as she has aged; she has been treated for emergency visits for Tachycardia; she frequently has developed respiratory issues as a result of the asthma which often landed her in the emergency and days in the hospital on oxygen. She often experienced shortness of breath and chest pain and last year underwent emergency appendicitis. Her last episode of atrial fibrillation which landed in the hospital was 12/29/16. She has been on anticoagulants for many years. Since COVID 19 she may not have been able to afford her Eliquis prescription however which she did not disclose to any of her family members that she was struggling in this wasy. She is likely not to have been taking her Hypothyrodism (Graves) medication either since these medications have not been recovered since her death.

Baker's cyst under knee burst; Covid-19 vaccine inflamed her immune system; ordered an ultrasound of the caller's leg because they thought it was a DVT; Crazy leg problem; Tinnitus; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14Apr2021 14:00 (age at vaccination 50-years) (Batch/Lot Number: EW0153) as DOSE 1,SINGLE for covid-19 immunisation. Medical history included ongoing hypothyroidism (diagnose when she was 25 years old), ongoing diabetes insipidus (was diagnosed 9 years ago), ongoing autoimmune condition. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism from an unspecified start date and ongoing (taking from when she was 25 years old, so 25 years ago); desmopressin taken for diabetes insipidus, start and stop date were not reported (started taking Desmopressin 9 years ago). Caller reported that she had seen 2 doctors and it seems like no one wants to report anything Caller reported that within 2 days of receiving the Covid-19 vaccine on 14Apr2021, she started getting a crazy leg problem on 16Apr2021. Caller reported that her primary care doctor ordered an ultrasound of the caller's leg because they thought it was a DVT on 16Apr2012. Caller reported that the Covid-19 vaccine threw her immune system off. Caller reported that she began having fibromyalgia symptoms, but she did not have fibromyalgia. Caller reported that the Covid-19 vaccine caused inflammation. Caller reported that the leg problem started in her right calf. she had fasciculations in her right calf, then her left calf. she then started getting internal vibrations or tremors. Caller reported that it was now occurring in her left arm. Caller reported that she was going to see a rheumatologist. Covid-19 vaccine inflamed her immune system on 16Apr2021 and it happened 2 days after she received the vaccine. Caller reported that she was afraid to give the Covid-19 vaccine to her kid. Autoimmune conditions run in her family and stated that she didn't know how much testing had been done of the Covid-19 vaccine on people with autoimmune conditions. Regarding Crazy leg thing Caller reported that it went from her right leg to her left leg to her left arm. Caller reported that it took forever to get to the rheumatologist and she was not even getting into them until 30Jun2021. She began experiencing tinnitus about 2 weeks after she received the Covid-19 vaccine (Apr2021). Patient did not receive second dose of Covid-19 vaccine Caller reported that after her reaction, her doctor instructed her to hold off on the second dose. Patient experienced baker's cyst under knee burst on an unspecified date. Outcome of the event Baker's cyst under knee burst and Covid-19 vaccine inflamed her immune system was unknown. Outcome of the other events was not recovered.

not taking 2nd dose; lethargic/crash culd not move; anaphylactic shock; difficulty breathing/shallow; difficulty breathing/shallow; tongue swollen and felt like bits of glass crystals were pushing out of my tongue for hours, like fiberglass; Severe weakness; shaking; chills; lethargic/crashed could not move; I got sicker and sicker and sicker; unknown collection of autism spectrum neurodevelopmental disorders; dysautonomia & all body systems dys- or mal-regulated and asynchronous; cognitive changes; Increasingly ill; feeling of dis-ease, something very wrong; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 21Apr2021 10:00 (at the age of 50-year-old) at dose 1, single for covid-19 immunisation. Medical history included Autism spectrum conditions (Autism spectrum conditions, but I don't know which genetic disorders or how many). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Yes too many to list here. Prior to vaccination, it was unknown whether the patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date in on May2021 the patient experienced an-aphylactic shock, difficulty breathing/shallow, tongue swollen and felt like bits of glass crystals were pushing out of my tongue for hours, like fiberglass, severe weakness, shaking, chills, lethargic/crashed could not move and on 21Apr2021 10:00 unknown collection of autism spectrum neurodevelopmental disorders, increasingly ill, dysautonomia & all body systems dys or mal-regulated and asynchronous, cognitive changes, feeling of disease, something very wrong, i got sicker and sicker and sicker. Increasingly ill to 30 days when I was experiencing such toxicity I called and ambulance & went to ER. dysautnomia & all body systems dys or mal-regulated asynchronous. Cognitive changes, feeling of did-ease, something very wrong not a vaccine cycle of reaction and resolution: I got sicker and sicker and sicker. Acute stage/30 days after: difficulty breathing/shallow, tongue swallow and felt like bits of glass crystals were pushing out of my tongue for hours, like fiberglass; severe weakness, shaking, chills, lethargic/crashed could not move. Patient believe that patient experienced anaphylactic shock response 30 days after my first dose. Patient has an unknown collection of autism spectrum neurodevelopmental disorders and physiological developmental disorders; Autists have unusual and long protein sequences, every-thing is affected. stuck with some effects; not taking 2nd dose, please do better by all the people with genetic conditions and by non-males. Patient did not receive treatment for the adverse events. Adverse events led to the emergency room visit. Outcome of the event not taking 2nd dose was unknown and remaining all the events was resolved with sequel on an unspecified date in 2021. No follow-up attempts are needed. Information on batch/lot number cannot be obtained.

Blood clots in right leg that traveled to both lungs; Blood clots in right leg that traveled to both lungs; This is a spontaneous report from a contactable consumer (patient herself). A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: ER8727, Expiry date was not reported) via an unspecified route of administration in arm right on 29Mar2021 (at the age of 50-years-old) as dose number unknown, single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: ER8735, Expiry date was not reported), via an unspecified route of administration in arm right on 29Mar2021 (at the age of 50-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included asthma, allergies, seafood allergy and nuts allergy. Concomitant medications included predni (PREDNISOLONE ACETATE), azelastine hydrochloride (ASTELIN [AZELASTINE HYDROCHLORIDE]) unknown daily at night and salbutamol (ALBUTEROL HFA) when needed. 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 has been tested for COVID-19. On 05Jun2021 at 09:00, the reporter stated that the patient experienced blood clots in right leg that travelled to both lungs. Her unprovoked event on 05Jun2021 and hospitalized for five days. The patient started taking blood thinners for the rest of my life. The reporter classified the events as serious and stated the events result in emergency room/department or urgent care, hospitalization for 5 days. The patient underwent lab tests and procedures on 05Jun2021 which included sars-cov-2 test (nasal swab): negative. Therapeutic measures were taken as a result of events with blood thinners. The outcome of the events was resolved with sequelae. Follow up needed, further information was requested.

Spotting vaginal bleeding; This is a spontaneous report from a contactable consumer (patient). A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 13May2021 01:30 (at the age of 50-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient had no took any past drug. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 13May2021 13:30, the patient experienced spotting vaginal bleeding. The outcome of event was not recovered. Information on the lot/batch, further information has been requested.

anaphylaxis; throat tightening; throat tightening/tingling; throat tightening/tingling/soreness; dry wheezy cough a little dizziness; dizziness; tachycardia; Itching; chills; numb R foot; Low grade temp; h/a today; This is a spontaneous report from a contactable Nurse (patient). A 51-years-old female patient (no pregnant) started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number el3248), via an unspecified route of administration on 06Jan2021 11:00 at the first single dose at left arm for covid-19 immunisation. Medical history included supraventricular tachycardia, adrenal insufficiency, hypothyroidism, attention deficit hyperactivity disorder, hypermobility syndrome, developmental hip. Concomitant medication included hydrocortisone, trazodone, levothyroxine sodium (LEVOTHROID), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin, morphine and experienced drug hypersensitivity. The patient experienced anaphylaxis, throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache on 06Jan2021 11:15. Seriousness criteria reported as life threatening. Taken to ER had IV benadryl, solumedrol, pepcid for anaphylaxis. Placed on O2 and given albuterol nebulizer. Had IV fluid bolus. Now on benadryl and 5 days of prednisone. The patient felt completely fine prior to vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 06Jan2021. The outcome of events was recovering. No other vaccine in four weeks; No covid prior vaccination.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis presented as throat tightening/tingling/soreness, dry wheezy cough a little dizziness and tachycardia. Itching, numb R foot, Low grade temp and chills and headache cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. The underlying predisposing condition of drug allergies may put the patient at high risk of anaphylactic reactions. 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.

COVID 19 Vaccination administered by pharmacy staff. No adverse effect at the present time. Staff will continue to observe adverse reaction. Will continue to monitor. Patient at start of shift awake in the bed. Pt at 3am was on the commode leaned to the side. Patient body still warm to touch no pulse. Called for assistance Asap. Cpr started promptly. Cpr given patient on floor 911 arrived at the scene at 3:10am Cpr rotated Between Nursing and EMT on Scene. Cpr was given to patient for over 45 minutes. Patient was pronounced at the scene at 3:50am. Call placed to Pt family by supervisor on shift. MD to be notified. AT 3:00am, I was notified by the nurse that resident is unresponsive. Upon entering room, resident was sitting on the commode unresponsive with absent respiration and pulse. Resident lowered down on the floor with 4 person assist. CPR initiated, AED pads placed on chest with no shock indicated. 911 called and EMT and paramedics arrived around 3:10am. ACLS performed until code stopped and pronounced death at 3:48am. I called and notified family member of his demise and awaiting for family to call us back for funeral arrangements.

Mild myalgias and headache the day after. On Saturday, January 23rd, I had an hour+long episode of Atrial fibrillation. While I have had other cardiac dysrhythmias throughout my adult life, this is the first time I have had diagnosed Afib. I took one dose of my PRN Propranalol (10mg) orally after a few minutes of the abnormal rhythm. When it didn't convert, I did go to the Emergency Department. My heart converted to normal sinus rhythm while on the monitor but before any other interventions were needed. I have a follow up appointment with my cardiologist tomorrow to determine further care as needed.

diagnosed with Covid-19 after the 1st dose; diagnosed with Covid-19 after the 1st dose; Pneumonia; Fever; Body aches; swollen lymph nodes under left armpit; Exposed to COVID; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a 51-year-old female patient received the first does of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 08:30 in left arm at single dose for covid-19 immunization. The patient medical history was none. Family medical history was no. Patient had been taking vitamin supplements. No vaccinations were taken within 4 weeks. Patient received first COVID-19 Vaccine on 21Dec2020 around 08:30. Between that three weeks period, patient was diagnosed with COVID. Patient was exposed the following weekend. Took four tests to finally test positive within a four-day-span. Patient was exposed to COVID on 26Dec2020. On 28Dec2020, patient experienced swollen lymph nodes under left armpit. Progressively got more sensitive on 29Dec2020. Patient thought maybe it was a side effect of the COVID-19 Vaccine. Wednesday morning, 30Dec2020, around 10:00 patient noticed body aches. Around 12:00 patient noticed a fever. On 30Dec2020, patient had a 24-hour lab test to check for COVID. All other COVID tests performed were rapid tests. First COVID test was on 30Dec2020. Patient had another COVID test on 31Dec2020, and two COVID tests on 02Jan2021. Patient was tested positive for COVID on 02Jan2021. COVID test that resulted positive was a rapid test in the emergency room. Patient was diagnosed with Covid-19 after the 1st dose. Patient was in the emergency room with pneumonia which occurred on 02Jan2021. It was confirmed patient was discharged from the emergency room six to seven hours after arrival. Lot number from patient card was either EJ1685 or ET1685. Caller unable to confirm lot number from patient card. Chest X-ray was what sent her to emergency room labs and blood work done on 02Jan2021 in emergency room. Labs were done in clinic a couple days before flu and strep test both negative on an unspecified date. Patient didn't remember all tests and results. Outcome of all events were unknown. Caller would like to know whether she should take the 2nd dose or not. Information on the lot/batch number has been requested.

Pt had 2nd vaccine, went home and started having "cramping" in all of her muscles. It became bad enough that she was taken to local ED where she then started coughing up blood, required intubation and about 6 hrs later, died.

1/12/21: Pt presented to ED with L sided facial droop, L sided weakness to arm and leg, numbness to L face L arm and left leg. Presentation consistent with acute ischemic stroke. Risks and benefits discussed with the patient, who agreed to proceed with tPA. MRI brain 1/12: "Acute infarct right MCA territory predominantly involving the right parietal/insular lobes. No acute hemorrhage or midline shift." Started on aspirin 325 mg daily and rosuvastatin dose increased to 40 mg daily 24 hours post tPA. Patient reported a history of a-flutter many years ago for which she was on a beta-blocker, but the diagnosis remains unconfirmed. Tele reviewed during stay, no arrhythmias. ECHO, normal EF, NO PFO. Discharged to rehab on 1/15.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Other- Anxiety/Panic-Medium

Patient received dose #1 of COVID-19 vaccine on 1/16/21. Within 3 days, she developed petechiae up to ankles, later rising up to her knees. Pt admitted to hospital on 2/6/21 for symptomatic anemia 2/2 vaginal bleeding. Patient received 4 units FFP, 4 units PRBC, 1 unit cryoprecipitate, and vitamin K 5 mg IV. Also started on medroxyprogesterone 20 mg PO TID. Alectinib d/ced due to worsening liver function. Evalauted by OB/GYN and Hematology. Diagnosed with DIC. Patient with worsening bilateral lower extremity edema and purpura with pain and weakness. Palliative care consulted. Patient passed away on 2/11.

Patient was administered the first dose in the Pfizer COVID vaccine series. During the observation portion, the patient passed out in the observation area approximately 10 minutes after receiving the dose and became non-responsive with ragged breathing. The pharmacy team responded and administered a dose of epinephrine 0.3mg to the patient immediately and called for EMS who arrived on the scene

Swollen lips, mild anaphylaxis, hives all started 60 minutes after vaccination. We traveled from our home (approx 2 hr drive) & were on road. My husband is a physician & when we noticed symptoms administered Benadryl, Claritin, & famatodine.

51 y/o female, no chronic health problems. 14 days following first COVID Pfizer vaccine, I felt unable to take a deep breath, on day 15 following the vaccine, I became short of breath,; on day 16 I was having mild chest pain with inspiration and shortness of breath; day 17 following vaccination I became significantly short of breath, with moderate to severe chest pain with inspiration and tachycardia (heart rate in the 140's). I called my PCP who ordered an EKG, CXR, COVID swab, a metabolic panel, a CBC, and a D-dimer. My D-dimer was elevated and he called me to go directly to the emergency department, which I did and had a CTA chest. I was diagnosed with multifocal pulmonary emboli in my right lung with a slight pleural effusion on my left lung. I had a duplex ultrasound of my legs which was negatve for DVT, and an echocardiogram which was within normal limits. I was finally diagnosed with acute unprovoked pulmonary embolism, given a Heparin bolus and started on a Heparin IV infusion. Ultimately, I transitioned to Eliquis PO and was discharged from the hospital within 24 hours.

Anaphylaxis. Five minutes after vaccination felt itching. Mouth, tongue, throat began swelling 10 minutes after vaccination. Received Benadryl, then treated with treated with epinephrine or EpiPen. Transported by EMS to hospital where she received IV famotidine and methylprednisolone sodium succinate.

left calf pain/ significant DVT in left quad; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL9264, unknown expiration), via an unspecified route of administration in left arm on 18Feb2021 as single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis and Leiden factor 5. Concomitant medications included etanercept (ENBREL); gabapentin; meloxicam; and vitamin D3. The patient previously took Keflex and experienced allergies. The patient also received first dose of BNT162B2 (Lot number: GL9261, unknown expiration) in left arm on 28Jan2021 at 01:00PM for COVID-19 immunization. On the night of second dose on 18Feb2021 at 08:00 PM (20:00), the patient experienced left calf pain. Then quad pain started 2 weeks later along with the return of calf pain. The patient was diagnosed on 15Mar2021 with a significant DVT in left quad. The patient did not receive other vaccine in four weeks. The patient had no COVID prior to vaccination and not tested for COVID post vaccination. The event significant DVT in left quad resulted in doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). The patient is currently on blood thinners as treatment. The patient is recovering from the event. No follow-up attempts are possible. No further information is expected.

Shortness of breath, chest heaviness onset 1 week. 1st vaccine injection 2/17/21, 2nd vaccine 3/17/21

heavy bleeding with lots of blood clots; extended and heavy menstrual period/ heavy bleeding with lots of blood clots; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer product), lot no. EN5318, via an unspecified route of administration (left arm) on 19Feb2021 at a single dose for COVID-19 immunisation at a workplace clinic. Medical history included high cholesterol and anxiety. No known allergies. No COVID prior to vaccination. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (brand: Pfizer, lot no. EL9261, left arm) for COVID-19 immunisation on 30Jan2021 at age of 50 years old. No other vaccine in four weeks. The patient was experiencing extended and heavy menstrual period. Her cycle began on 05Mar2021 and was still happening as of today 16Mar2021. She had heavy bleeding with lots of blood clots. This was not normal for her at all. She is calling her doctor tomorrow. No treatment received for the events. No COVID test post vaccination. The outcome of the events was not recovered.

Patient developed anaphylactic reaction after vaccination. Patient pretreated with 50 mg of benadryl and 3 hours after vaccination had to take 50 mg more of Benadryl due to throat closing up, hives and increased heart rate. Went to physician assistant and received 50 mg Benadryl and medrol dose pak. Patient also used albuterol MDI. Symptoms resolved 6 hours after vaccination. Continued to have a headache, injection site pain and fatigue for 24 hours.

blood clot in her lungs; shortness of breath; chest pain; This is a spontaneous report from a non-contactable consumer. A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Mar2021 as single dose for COVID-19 immunisation. Medical history included obesity and inactivity. The patient's concomitant medications were not reported. On an unspecified date, patient experienced blood clot in her lungs and was hospitalized on 14Mar2021. Patient also experienced shortness of breath and chest pain on an unspecified date. She was treated with anticoagulant therapy for the event "blood clot in her lungs". Outcome of event "blood clot in her lungs" recovered on an unspecified date while for all other events was unknown. No follow-up attempts are Possible. Information on lot/batch cannot be obtained.

Patient received second dose of Pfizer BioNTech COVID Vaccine on 2/23/21. On 2/25 patient called PCP office expressing swollen & painful lymph node to left clavicle/shoulder area . Same arm as injection. Pain 2-3/10. Pt denied any other symptoms. Managed with warm compress, however on 3/26/21 patient went to the emergency room with complaint of continued swelling and redness on left arm. Ultra sound of the upper extremity showed short segment Nonocclusive thrombus in the left proximal subclavian

DVT (deep vein thrombosis) in right medial subclavian; superficial thrombosis in right proximal basilic vein; right arm swelling in the setting of receiving her Pfizer covid vaccine in the right arm 1 week prior; This is a spontaneous report received from a contactable healthcare professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in arm right in Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Medical history included hyperlipidemia, acute pancreatitis, May-Thurner syndrome, and allergies: penicillin, IV contrast. Concomitant medications included drospirenone, ethinylestradiol betadex clathrate (YAZ), fenofibrate, and levothyroxine. Patient is not pregnant at the time of vaccination. 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. Patient has not been tested for COVID-19 since the vaccination. Patient was seen at the ED for right arm swelling in the setting of receiving her Pfizer COVID vaccine in the right arm 1 week prior. She was found to have a DVT (deep vein thrombosis) in right medial subclavian and superficial thrombosis in right proximal basilic vein. The events started on 17Mar2021 09:00. AE resulted in emergency room/department or urgent care. Patient was recovering from the events. Treatment for AEs include anticoagulation. Information about lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the DVT and other reported events, based on temporal relationship. However the reported events may likely represent intercurrent medical conditions in this patient. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

6 days of heavy periods with large clots up to this morning. First time after several years of only light spotting (IUD/premenopausal). Lighter menstruation today.

Experienced severe allergic reaction resulting in anaphylaxis requiring emergency treatment @ ER. Swelling of face and neck, eyes swollen shut, hives on upper body, difficulty breathing.

Vaccine did hit me hard the day after, all day Friday, and managed as many naps as possible but keeping G?s routine going. As the night went on, I found it more difficult to stay awake. I experienced something I have not experienced in almost 20 years. I suffered from a few bouts of sleep paralysis in my 20s. It was horrifying to be awake and unable to move a muscle and you can even make a sound. Last Friday, I literally stopped breathing (never happened b4) and woke up paralyzed just for a few moments and when I regained movement, I was gasping for air. I was so scared because it kept happening shortly after falling asleep but I could not stay awake. I am not sure if my fibromyalgia played a part in this or not. I have also been experiencing more shortness of breath since then and the last two days constant ear ringing. It is hard to focus with the high pitch ringing in my ear. I am out of breath with such little movement required.

Ariived to find 51 year old female actively seizing whiling prone on the floor. Pt was convulsing consistent with grandma seizure . Patience skin colour was normal and maintained her own airway without assistance. Pt skin color was normal and maintained her own airway without assistance. Patients breathing Was rapid but sufficient. Pt became postictal on the floor . Pt began seizing a 2nd time . Pt was rolled into left lateral position Pt was lifed on to the stretcher, began seizing for the 3rd time . pt was tf into the ems room. Pt became posticsl and began to recovering an had an increasing level of awareness. Pt states she had a hx of anxiety driven seizure and her lastbone was about a month ago. Pt vs were evaluated. Pt declind transport to ed against medical advice.

Roughly a month after the vaccine, had shortness of breath, low oxygen level, disabling fatigue, bad headache, coughing up blood. Symptoms worsened over 3 weeks. Considered asthma, then pneumonia (with antibiotics), conditions worsened, so referred to a pulmonologist.

PRESENTS 4/26 TO HOSPITAL EMERGENCY DEPARTMENT (ED) 5 DAYS POST VACCINATION WITH TONGUE SWELLING , SOB WHILE IN ED HAD CARDIAC ARREST, WAS RESUSCITATED, INTUBATED AND TRANFERRED TO ICU. IS CURRENTLY ON VENTILATOR AND VASOPRESSOR SUPPORT.

Patient s/p second Pfizer COVID vaccine 4/17/21. Presents to ED 4/28 with slurred speech & left hemiplegia. CT imaging revealed R MCA CVA. Patient s/p thrombectomy for CVA. CT also had question of L transverse venous sinus thrombosis. On 4/29, patient went for MRI which confirmed multiple anterior and posterior circulation strokes and nonocclusive left transverse dural vein thrombus. Platelets at the time of presentation are normal. Heparin drip initiated 4/29 after consult with hematology (patient also high bleeding risk due to HHT). IF CT head stable 4/30, Patient will be transitioned to oral anticoagulation with close monitoring by hematology given bleeding risk.

Large blood Clotting after each dose during menstral cycle.Bled for more than 2 weeks.; Large blood Clotting after each dose during menstral cycle.Bled for more than 2 weeks.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 19Mar2021 04:15 (at 51 years old, not pregnant), single dose for covid-19 immunisation. Medical history included stroke, high blood pressure, diabetes mellitus, all from an unknown date and unknown if ongoing. The patient's concomitant medications was unspecified (mentioned other medications in two weeks: yes but prescribed). The patient had her first dose of BNT162B2 vaccine on 26Feb2021 04:15 at 51 years old, for COVID-19 immunisation on left arm. The patient experienced large blood Clotting after each dose during menstral cycle. Bled for more than 2 weeks. All on 27Mar2021 12:00. No other vaccine in four weeks. No covid prior vaccination. Not covid tested post vaccination. No known allergies. No treatment for the events. The outcome of the events was unknown. Information about lot/batch number has been requested.

I am in menopause, 19 days after the shot I started bleeding and it is VERY heavy. I am still bleeding and it?s been 7 days still heavy as well. I called the dr on Thursday, April 29 and she set up an ultra sound , but I didn?t even mention to her that I had a shot because I hadn?t heard about this happening until I had already spoke with the dr. Also very tired but I think that?s from bleeding so much. Not sure if there?s any way to know for sure if it was caused by the shot but if they do t find anything else wrong with me I?m going to assume it?s from the shot since it seems to be happening to a lot of women

Ischemic Stroke: I was sick with flu like symptoms the day after my test, including headache, fever, chills, fatigue and body aches. I rested and treated with ibuprofen and tylenol. The second day after I was well enough to return to normal activities. However, after dinner, my left hand seized up and I had to shake out my hand to get it working again. This event lasted about 30 seconds. I had some small tingling in the evening after that. The next morining when I woke up my left arm was not functioning properly. It was weak, slow and I could not close my hand in a grip. My husband drove me to the ER where I received many tests over 3 days, resulting in the diagnosis of an ischemic stroke on the right side of my brain. Most of my arm function returned late afternoon the same day I was admitted.

Vaginal bleeding like usual menstruation that has not stopped. Plan for oral contraceptives and/or depo injection to stop the bleeding.

bleeding heavily with small clots; has not had menstrual cycle since 2018; started spotting; bleeding heavily with small clots; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 08Apr2021 11:30 (at the age of 51-year-old) as a single dose for COVID-19 immunization. Medical history included endometriosis diagnosed in 1993 and subsequently she had laparoscopy twice by the age of 26-year-old; and ongoing menopause since 2018. History of Parity 1: the patient was pregnant with her daughter and have her naturally at 27 years old and never had another pregnancy again. The patient's concomitant medications were only women multi-vitamins. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she has not had menstrual cycle since 2018. On 23Apr2021, the patient started spotting. Since 26Apr2021, she has been bleeding heavily with small clots. All day today (on 28Apr2021) she has been bleeding very very heavy with clots. She was planning to go to her doctor by morning, but she was following through with her second dose tomorrow (29Apr2021). The clinical outcome of the events "have not had menstrual cycle since 2018; started spotting; bleeding heavily with small clots" were not resolved. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient reported that she received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EWO151) via an unspecified route in the left arm on 14Apr2021 at 11:30 (at the age of 51-years-old) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications the patient received within 2 weeks of vaccination included insulin and metformin. On 15Apr2021 at 06:00 (reported as18 hours later), the patient had a "gran map seizure" and had to be taken to the hospital via ambulance. The event resulted in visit to emergency room/department or urgent care. The patient was not treated for "gran map seizure". The clinical outcome of "gran map seizure" was unknown. Since the vaccination, the patient has not been tested for COVID-19.

Perhaps this is a very mild case of thrombocytopenia?; develop bruises and petechiae, which "travel" up and down my thigh corresponding to where I scratch; develop bruises and petechiae, which "travel" up and down my thigh corresponding to where I scratch; severe muscle and joint pain; severe muscle and joint pain; low electrical shock in limbs; hives all over my body which would welt up like measles if I scratched them; This is a spontaneous report from a contactable Consumer (patient). A 51-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Apr2021 12:45 (at 51 years old, not pregnant) (Batch/Lot Number: EP7533) as 2nd dose, single for covid-19 immunisation. Medical history included cholesteatoma from an unknown date (Cholesteatoma as a teen--resolved with modified canal-wall down tympanomastoidectomy. No problems since 1989-1990), Allergy to cephalosporins, Sulfa drugs, strawberries, all from an unknown date. The patient had no concomitant medications. The patient had her first dose of bnt162b2 (Lot numberEN6204) vaccine on Mar2021 12:45 at 51 years old on left arm for COVID-19 Immunization.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second dose, after about 12 hours (reported also as 09Apr2021 22:00), as expected, patient had moderate to severe muscle and joint pain and a sensation of low electrical shock in limbs. No other symptoms and this resolved in 24 hrs. Eight days after dose 2 (reported also as 09Apr2021 22:00), patient developed hives all over the body which would welt up like measles if patient scratched them. Patient tolerated them for 19 days before patient finally sought help from a doctor, who prescribed a short 20mg/2X/day course of prednisone and hives are improving significantly. However, wherever she scratches these hives on her legs,especially right, she developed bruises and petechiae, which "travel" up and down her thigh corresponding to where she scratches. She was in good health, active, and don't bruise easily. Bruising has not resolved over about 23 days, but has not gotten worse. Patient has no other symptoms. Perhaps this is a very mild case of thrombocytopenia. The adverse events resulted in visit to Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was Prednisone. Prior to vaccination, the patient was not diagnosed with COVID-19.Since the vaccination, the patient has been tested for COVID-19. All the events start date was reported as 09Apr2021 22:00 (for clarification). The outcome of the vaccines was recovering. The patient underwent lab tests and procedures which included Weekly spit test--work: negative on 11Mar2021; negative on 18Mar2021; negative on 25Mar2021; negative on 08Apr2021; negative on 19Apr2021; pending on 28Apr2021. Device used Date : 02May2021 Information about Lot/batch number was available. Further information was expected.

she had developed a blood clot in her lungs; coughing up blood; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 51-years-old), administered in Deltoid Right (reported as "right upper arm shoulder") on 07Apr2021 09:45 (Lot Number: EW0150) as 2nd dose, single for COVID-19 immunization. Medical history included eosinophilic granulomatosis with polyangiitis (Churg Strauss syndrome) and asthma. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Right upper arm shoulder on 17Mar2021 (Lot Number: EN6208) as 1st dose, single for COVID-19 immunization. The second dose of the vaccine the patient received on 07Apr2021 and she had a great experience with it and nothing happened. Then on 30Apr2021, patient experienced coughing up blood, which required a visit to the Emergency Room. She was admitted in the hospital on 30Apr2021, and they discovered a clot in her lung she is surprised to find out because she is very healthy individual. She had got out of the hospital yesterday (03May2021) for a blood clot in her lungs where the hospital did a bronchoscopy, they cut it out. The blood clot was big and deep. They did a test to see if the blood clot is from her rare disease which it was not so the doctors have no idea what caused the blood clot. She did her research and the only thing that had changed was she got the vaccine and then she also just switched to a different inhaler for her asthma but she has taken it before. The doctors do not think it is any of the two things. The doctor does not know what caused the blood clot and she saw there has been 35 cases reported of a rare blood clot and according to her findings. She was hospitalized for 3 nights (when discovered a clot in her lung) from 30Apr2021 to 03May2021. The blood clot was removed Sunday 02May2021. She had blood work done prior to the vaccine and her count was excellent. The patient underwent lab tests and procedures which included blood test: her count was excellent prior to the vaccine, blood test: it was not (from her rare disease), bronchoscopy: blood clot, electrocardiogram: well, full blood count: well, liver function test: well, thyroid function test: it need to be adjusted: all on unspecified dates. The patient reported that, "hospital where my blood drawn, oh actual testing too many to mention, CBC (complete blood count), ECG (electrocardiogram), Liver function lot of different test. Everything was well except my thyroid it need to be adjusted am taking care of it. It was Saturday prior to the second shot maybe I don't know." Therapeutic measures were taken as a result of the events which included bronchoscopy, they cut it out, they did a catheter in upper part of left lung. The outcome of the events was recovered on 02May2021. There were no prior vaccinations (within 4 weeks). No adverse events following prior vaccinations.

Patient got the Pfizer vaccine on 5/22 at about 4:30pm. She did not have an immediate reaction. The next morning she noticed some swelling in the face and it progressed to the jaw and then started to feel throat tightness at which point she went to the urgent care with an anaphylactic reaction. They gave her a steroid injection.

Developed multiple blood clots in both lungs became extremely short of breath with any activity, heart palpitation, tachycardic

As I stated previously, I received the first shot on 01/05/2021. One week after I got sick and had a covid test which came back negative. Then I got the second vaccine on 02/05/2021. On Feb 14,2021 I woke up at 1:00 am and had severe back pain. Within about 10 mins the pain shot to my chest. I went to the emergency room. My troponin level continued to elevate and I was admitted for 2 days. I had a cardiac catherization and all my arteries were completely clear. It was later determined that I had a non stemi MI. There was swelling around my pericardium of the heart. Following this event I have also been having shortness of breath and also seeing a pulmonologist. The pulmonologist believes the lung issue is related to my initial heart problem, from Feb 14,2021. I am currently being treated for viral asthma. I am on two inhalers, and a round of prednisone as of May 25,2021. I have never had any health issues prior to these events. I do not know for sure that the events are related to the vaccine but it certainly is a coincidence that everything started happening after I was vaccinated.