Pfizer

Life threatening symptom reports

Female, 40 - 59 years

Age Reported Symptoms Notes
40 2021-01-09 anaphylactic reaction Immediate redness/burning of the injection site. Progressed to itchy throat/tongue and hoarse voice ... Read more
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.
40 2021-01-13 anaphylactic reaction Patient present with anxiety, palpitations, tachycardia, dizziness and fatigue during the observatio... Read more
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%.
40 2021-01-19 vaginal haemorrhage Pt was 18 weeks pregnant at the time of the vaccine. Second pregnancy. Pt is a physician. Pregnancy... Read more
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.
40 2021-01-26 anaphylactic reaction After receiving vaccine developed dizziness and hypotension, then developed itchiness in throat. EP... Read more
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.
40 2021-02-03 pneumonia December 28,(before the vaccine) I was exposed to COVID at work. I started feeling feverish on Mond... Read more
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.
40 2021-02-16 blood clot Headache, nausea, vomiting, sore arm, temp 102.8, chills began 1/08/2021 @ 9pm and lasted for 24 hou... Read more
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
40 2021-02-23 vaginal haemorrhage Headache lasting greater than 1 week, extreme fatigue and vaginal bleeding. Normally no headaches an... Read more
Headache lasting greater than 1 week, extreme fatigue and vaginal bleeding. Normally no headaches and very regular cycle
40 2021-02-28 vaginal haemorrhage I was about 9 weeks pregnant with no complications at the time of my second vaccination. Estimated ... Read more
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.
40 2021-03-23 anaphylactic reaction Anaphylaxia, breathing trouble
40 2021-03-23 anaphylactic reaction 1:39 PM - Vaccine administered 1:40PM - Anaphylactic reaction began (difficulty breathing) 1:40PM - ... Read more
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.
40 2021-03-24 excessive bleeding Severe bleeding resolved within 7 days
40 2021-03-25 vaginal haemorrhage My first dose was 1/14. I found out I was pregnant on 1/26/21 and I miscarried at about 10 weeks. Ab... Read more
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.
40 2021-03-30 anaphylactic shock Anaphylactic shock. Tongue, Hands and feet swelling. Hives all over body, skin felt like it was burn... Read more
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.
40 2021-04-01 anaphylactic reaction Signs/Symptoms: severe dyspnea, wheezing, anaphylaxis Treatment: Epi Pen (Left Anterior Thigh) and... Read more
Signs/Symptoms: severe dyspnea, wheezing, anaphylaxis Treatment: Epi Pen (Left Anterior Thigh) and EMT Called/Transported to Hospital Emergency Department.
40 2021-04-04 anaphylactic reaction Experienced brief, minor dizziness about 10 minutes after the shot. On my drive home about 15-20 min... Read more
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.
40 2021-04-04 excessive bleeding I start seeing blood spots with passing tissues since then. no pain or any feeling. just slight blee... Read more
I start seeing blood spots with passing tissues since then. no pain or any feeling. just slight bleeding. Called the doctors. they are monitoring
40 2021-04-06 vaginal haemorrhage The next morning after I had arm pain and was very fatigued which lasted about a week. On 2/27 I s... Read more
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.
40 2021-04-08 anaphylactic reaction Patient received Pfizer COVID-19 vaccine on 4/6/2021. Patient reports the following adverse reactio... Read more
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.
40 2021-04-08 pulmonary embolism pulmonary embolism, symptomatic
40 2021-04-14 anaphylactic shock Amphylactic shock Numb arm Breathing Throat swelling
40 2021-04-15 anaphylactic reaction Severe hives all over and anaphylaxis reaction
40 2021-04-17 deep vein blood clot Approximately 11 days s/p 2nd vaccination, patient developed calf pain. After the pain persisted for... Read more
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.
40 2021-04-17 blood clot Repeated, extreme nosebleed with large clots. I was unable to stop it and had to go to the ER on 4/1... Read more
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.
40 2021-04-18 blood clot On 04/01/2021 I had a random nose bleed and passed a clot the size of half of a bean.
40 2021-04-21 grand mal seizure Nausea, vomting, palpitations starting 10 minutes after vaccine administration. Generalized Tonic S... Read more
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.
40 2021-04-21 vaginal haemorrhage Pt went to the ER on 4/19/21 with vaginal bleeding and cramping at approx. 6 wks gestation per LMP. ... Read more
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.
40 2021-04-22 deep vein blood clot Headache, confusion, muscle and joint pain, inflammation, fatigue, etc etc. Including LUPUS FLARE- ... Read more
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.
40 2021-04-22 vaginal haemorrhage I got my period on April 1, and in 30 years of menstruating, it was the worst period I've ever had. ... Read more
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).
40 2021-04-24 anaphylactic reaction anaphylaxis; rash/hives on face; rash/hives on face; progressed to swollen lips, tongue; progressed ... Read more
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.
40 2021-04-26 ischaemic stroke, cerebrovascular accident Patient had a CT head without contrast that demonstrated hypodensity within left MCA territory. CT ... Read more
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
40 2021-04-26 pulmonary embolism First dose given 03/17/2021: momentary adverse reaction: racing heartbeat. Second dose given: 04/08/... Read more
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.
40 2021-04-26 transient ischaemic attack Possible TIA (diagnosed in Urgent Care); loss of balance; dizziness; headaches; neck pain; blurred v... Read more
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.
40 2021-04-28 pneumonia 1/28 1st Pfizer > 1/29 Onset, dizziness, nausea, h/a, eye pressure, "heaviness" in legs, altered tas... Read more
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.
40 2021-05-02 blood clot Headache stomach issues and arm pain Thursday chest pain and shortness of breathe went to the er had... Read more
Headache stomach issues and arm pain Thursday chest pain and shortness of breathe went to the er had blood clots
40 2021-05-03 vaginal haemorrhage, blood clot more than usual vaginal bleeding/with very dark blood with clots.; menstrual cramps; sharp pelvic pa... Read more
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.
40 2021-05-04 blood clot, vaginal haemorrhage vaginal bleeding/blood clots at mid-cycle; vaginal bleeding/blood clots at mid-cycle; vaginal bleedi... Read more
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.
40 2021-05-05 excessive bleeding Irregular menstrual cycle--18 days instead of usual 28 days, and bleeding occurred exactly 1 week fr... Read more
Irregular menstrual cycle--18 days instead of usual 28 days, and bleeding occurred exactly 1 week from each of the two doses.
40 2021-05-07 blood clot in lung blood clots in left lung which turned into an infarction; blood clots in left lung which turned into... Read more
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.
40 2021-05-09 cerebrovascular accident Patient received 2 doses of Covid-19 vaccine. First dose on 3/20/21 and 2nd dose on 04/10/21 Adverse... Read more
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.
40 2021-05-10 pulmonary embolism PATIENT HAD SHORTNESS OF BREATH FOR THE PAST 2-3 WEEKS DIAGNOSED WITH PULMONARY EMBOLISM AND PLEURAL... Read more
PATIENT HAD SHORTNESS OF BREATH FOR THE PAST 2-3 WEEKS DIAGNOSED WITH PULMONARY EMBOLISM AND PLEURAL EFFUSION
40 2021-05-17 excessive bleeding, blood clot Placental abruption (with heavy bleeding) occurred two days short of week 36 in first pregnancy (whi... Read more
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.
40 2021-05-19 vaginal haemorrhage Found out I was pregnant day after shot week later I was bleeding for 3 days kind of like a period t... Read more
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
40 2021-05-21 vaginal haemorrhage I was 7 weeks pregnant and received 2nd Pfizer vaccine, on the same day started having virginal blee... Read more
I was 7 weeks pregnant and received 2nd Pfizer vaccine, on the same day started having virginal bleeding and crumping, had miscarriage next day.
40 2021-05-22 excessive bleeding Right after vaccine injection site was extremely itchy. After a few minutes of vaccine my whole body... Read more
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
40 2021-05-24 fluid around the heart Two weeks after the first Pfizer shot, I experienced labored breathing, congestion, fluid around my ... Read more
Two weeks after the first Pfizer shot, I experienced labored breathing, congestion, fluid around my heart and left side numbness and stabbing head pain.
40 2021-05-30 blood clot, pulmonary embolism, deep vein blood clot On 5/28/2021 I started to develop shortness of breath. It continued to worsen and I went to the hosp... Read more
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.
40 2021-05-31 vaginal haemorrhage Frequent and irregular vaginal bleeding
40 2021-06-06 anaphylactic shock anaphylactic shock (fully body hives/extreme swelling of faces, neck, and limbs/ full body rash/pain... Read more
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)
40 2021-06-07 death Sudden death in sleep
40 2021-06-08 blood clot AFTER THE FIRST VACCINE: HERPES BASED BLISTERS IN MOUTH TO THE POINT THAT TAKING OR EATING WAS VERY ... Read more
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.
40 2021-06-11 pulmonary embolism blood disorder; hypercoaguability; Pulmonary embolism; pulmonary infarct; This is a spontaneous repo... Read more
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.
40 2021-06-12 blood clot Sharp pain in left leg toe for 30 minutes then a bumpy feeling. Next day morning showed up a bruise ... Read more
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.
40 2021-06-13 ventricular tachycardia Patient developed palpitations and dizziness two days after 2nd Pfizer COVID-19 dose (4/5/21) and th... Read more
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.
40 2021-06-18 blood clot bleeds were difficult to stop (lasting 15 or more minutes) and with clots; severe nosebleeds; This i... Read more
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.
40 2021-06-18 vaginal haemorrhage reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 ... Read more
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.
40 2021-06-18 vaginal haemorrhage Patient was approximated 10 weeks pregnant and received her second dose of the Pfizer vaccine on 6/... Read more
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
40 2021-06-20 excessive bleeding I have been bleeding since the shot.
40 2021-06-22 pulmonary embolism Pulmonary Embolus in both lungs
40 2021-06-23 blood clot feminine blood spotting starting about 4 days pos 2nd injection. Early menstruation cycle start lead... Read more
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.
40 2021-06-25 cardiac arrest Sudden Cardiac Arrest, needed to be defibrillated twice. Life support for 2 days. No previous health... Read more
Sudden Cardiac Arrest, needed to be defibrillated twice. Life support for 2 days. No previous health issues. Hospital stay for 7 days. ICD implanted.
40 2021-06-28 low blood platelet count she was hospitalized for 4 days and treated for ITP.; nose bleed; Caller states she gave birth to he... Read more
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.
40 2021-07-01 heart failure My heart stopped; This is a spontaneous report from a contactable consumer (patient). A 40-year-old ... Read more
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.
40 2021-07-01 respiratory arrest Heart started racing/palpating, glanced at clock- 12:23PM roughly 30 minutes after getting the vacci... Read more
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.
40 2021-07-05 cardio-respiratory arrest On June 10th I began to have chest pain. It was very bad so I went to the ER. 10 minutes after a... Read more
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.
40 2021-07-06 blood clot Symptoms Shot January 10 Sore arm Fever headache cough 7 days Brain fog persistent headaches No pe... Read more
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
40 2021-07-12 vaginal haemorrhage Monthly cycle has been heavy bleeding, defibrilating cramps, and unpredictable. Spotting moments aft... Read more
Monthly cycle has been heavy bleeding, defibrilating cramps, and unpredictable. Spotting moments after the vaccine. Chest pain, and pins and needle sensation in legs.
40 2021-07-15 deep vein blood clot DVT left saphenous vein and left common femoral vein. Redness and tenderness inside of left thigh x... Read more
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.
40 2021-07-18 fluid around the heart Blood clot in liver and fluid around heart
40 2021-07-19 heart attack NSTEMI (non-ST elevated myocardial infarction)
40 2021-07-19 blood clot Patient returned for her second Pfizer Covid vaccine on 7/20/21 and stated that she had been treated... Read more
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
40 2021-07-21 atrial fibrillation Contracted covid between doses of the vaccine, and had AFIB several months later in May (4 months af... Read more
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.
41 2021-01-06 anaphylactic reaction Hives, sneezing, anaphylaxis, wheezing, itchy throat, stuffy, started in evening, hives first then i... Read more
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
41 2021-01-07 anaphylactic reaction anaphylaxis with immediate whole body swelling. Epinephrine 0.3mg IM administered
41 2021-01-07 atrial fibrillation Got vaccine at 1:15. At 1:27. Became very hot, red rash all over, tachycardia . I alerted the nur... Read more
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.
41 2021-01-13 anaphylactic reaction Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightn... Read more
Systemic: Anaphylaxis-Mild, Systemic: feelt tingling and warm sensation inside the body, felt tightness in throat; symptoms lasted 0 days
41 2021-01-14 anaphylactic reaction About 10 minutes after getting my vaccine I noticed the roof of my mouth itching as well as my tongu... Read more
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.
41 2021-01-19 low blood platelet count Patient got her 2nd dose of Pfizer covid vaccine on 1/8. On 1/11 she had intermittent chest pain th... Read more
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.
41 2021-01-20 severe muscle breakdown Rhabdomyolysis
41 2021-01-27 low platelet count neutropenia & thrombocytopenia
41 2021-02-03 anaphylactic reaction Anaphylactic reaction to COVID-19 booster (2nd shot) Refractive Asthma brought on due to anaphylaxi... Read more
Anaphylactic reaction to COVID-19 booster (2nd shot) Refractive Asthma brought on due to anaphylaxis
41 2021-02-14 anaphylactic reaction Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Systemic: Allergic: ... Read more
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
41 2021-02-16 blood clot, deep vein blood clot Noticed swelling in my left hand around Feb 6th, but by Feb 13th entire left arm was swollen and war... Read more
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.
41 2021-02-18 anaphylactic reaction Anaphylaxis
41 2021-02-20 blood clot extreme muscle pain for 24 hrs . started immediately as minimal and increase to extreme within 3 hrs... Read more
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.
41 2021-02-21 deep vein blood clot deep vein thrombosis in lower left leg; mild fever; fatigue; body aches all in the day following inj... Read more
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
41 2021-02-22 anaphylactic shock Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache.... Read more
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.
41 2021-03-10 anaphylactic reaction ITCHING ALL OVER, SCRATCHY THROAT, ANAPHYLAXIS PT PREMEDICATED WITH BENADRYL 50MG PO AT HOME PRIOR T... Read more
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
41 2021-03-11 anaphylactic reaction Anaphylaxis, swollen throat, itchy lips, hives.
41 2021-03-23 low blood platelet count Developed ITP (Idiopathic Thrombocytopenia Pura); This is a spontaneous report from a contactable co... Read more
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.
41 2021-03-31 anaphylactic reaction Anaphylactic reaction; Tachycardia/she felt her heart going fast; her throat starting to close/ Sens... Read more
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.
41 2021-04-03 anaphylactic shock Anaphylactic Shock; Allergic reaction; This is a spontaneous report from a contactable consumer (pat... Read more
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.
41 2021-04-04 anaphylactic reaction 45 minutes after injection of Pfizer (dose 1) patient felt dizzy. Was brought back to nurse that adm... Read more
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.
41 2021-04-07 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Aller... Read more
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
41 2021-04-12 sepsis Patient came to EC for suspected sepsis, fatigue, fever, and generalized body aches, recent chemo 6 ... Read more
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
41 2021-04-12 blood clot Delivered preterm infant (stillbirth) at 24 weeks on March 9, 2021. Infant had IUGR noted at 19 we... Read more
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.
41 2021-04-12 vaginal haemorrhage Period-type vaginal bleeding. Dark blood. My last period was less than 2 weeks ago, so this is not a... Read more
Period-type vaginal bleeding. Dark blood. My last period was less than 2 weeks ago, so this is not a timely period.
41 2021-04-13 pulmonary embolism Shortness of breath and chest pain 4/9/21 Went to ER on 4/9/21 Diagnosed with Multiple Pulmonary Emb... Read more
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
41 2021-04-14 deep vein blood clot Superficial blood clots in both upper legs; each leg had one in the front and one in the back. They ... Read more
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.
41 2021-04-15 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-... Read more
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe
41 2021-04-15 deep vein blood clot Six days after my second shot of Pfizer I got a DVT Clot in my left leg behind the knee. Started wit... Read more
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.
41 2021-04-15 vaginal haemorrhage I tested positive for pregnancy on March 17, 2021. on March 24th I got my first dose of the Pfizer v... Read more
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
41 2021-04-16 pulmonary embolism Short Summary: DVT followed by Multiple Bilateral Pulmonary Embolisms (significant blood clots in bo... Read more
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).
41 2021-04-18 atrial fibrillation My heart went into A-fib and was racing for almost a week. Beating really really hard. I was trav... Read more
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).
41 2021-04-19 blood clot Superficial venous thrombosis of left arm Start 2 days after shot, heat, ibuprofen
41 2021-04-21 anaphylactic reaction 20 minutes after my second shot, I developed wheezing at the base of my throat. It did not escalate ... Read more
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.
41 2021-04-22 anaphylactic reaction Patient developed hives on their chest and bilateral arms and difficulty breathing with concerns for... Read more
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.
41 2021-04-22 atrial fibrillation 5 days after receiving my first vaccine, my heart went into Atrial Fibulation. That has never happen... Read more
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.
41 2021-04-22 pulmonary embolism Shortness of breath Rapid heart rate Pulmonary embolisms (bilateral)
41 2021-04-22 pulmonary embolism The patient received the Pfizer COVID vaccine and did not have any apparent reaction initially. Six... Read more
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.
41 2021-04-24 grand mal seizure Grand mal seizure; This is a spontaneous report from a contactable consumer (patient). A 41-year-old... Read more
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.
41 2021-04-24 excessive bleeding hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme majo... Read more
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.
41 2021-04-24 blood clot Started 10 minute after the shot I was nauseous with a headache watery eyes , nose I had an asthma a... Read more
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
41 2021-04-25 heart attack Patient woke up with jaw pain and left arm pain. When this didn't subside, she went to the ER and w... Read more
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).
41 2021-04-25 vaginal haemorrhage My menstrual cycle was extremely heavy and I passed many large clots, similar to when I had a miscar... Read more
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.
41 2021-04-27 anaphylactic reaction asthmatic reaction like hard time breathing; hard time walking; weak; No appetite; anapylactic react... Read more
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.
41 2021-04-27 deep vein blood clot DVT of femoral vein of left lower extremity, shortness of breath during exertion, cough, diaphoresis... Read more
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.
41 2021-04-27 excessive bleeding Pt. started having fever that evening, headache, and lower back pain (significant). Yesterday drove ... Read more
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.
41 2021-04-27 vaginal haemorrhage Vaginal bleeding/spotting since day after covid vaccine to present, also the day of to a week after,... Read more
Vaginal bleeding/spotting since day after covid vaccine to present, also the day of to a week after, I had bloating and gas.
41 2021-04-28 cerebrovascular accident vomting, collapsing, dizzy, couldn't feel hands, speech impaired, small stroke
41 2021-04-30 cerebrovascular accident migraine; she felt like she had had her third back surgery; throwing up; diarrhea; stomach cramps; b... Read more
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.
41 2021-04-30 excessive bleeding bleeding; Rash; itching; hives; pain in head, shoulders; pain in head, shoulders; pain in head, shou... Read more
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.
41 2021-04-30 excessive bleeding I was having an abortion; cramps; bleeding (light red); This is a spontaneous report from a contacta... Read more
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.
41 2021-05-03 anaphylactic reaction About 15 mins after vaccine I felt a sudden onset of lightheadedness and feeling as if i would pass ... Read more
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.
41 2021-05-06 blood clot Clotting and breakthrough bleeding for 4 weeks following 1st vaccination, then swelling of lymph nod... Read more
Clotting and breakthrough bleeding for 4 weeks following 1st vaccination, then swelling of lymph nodes 48 hrs. following 2nd vaccination.
41 2021-05-13 excessive bleeding Menstrual cramps and bleeding that started a day after the vaccine and have lasted over a week. This... Read more
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.
41 2021-05-14 deep vein blood clot Left calf pain started around 4/12; went to Total Access Urgent Care on 4/28 as pain had increased w... Read more
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.
41 2021-05-14 severe muscle breakdown Rhabdomyolysis
41 2021-05-16 blood clot Transient moderate headaches and nose bleeds 3-7 days post-injection, including sneezing out blood c... Read more
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
41 2021-05-18 pulmonary embolism Pulmonary Emboli, Shortness of breath started on 4/30/2021, just after arthroscopy of RLE on 4/28/20... Read more
Pulmonary Emboli, Shortness of breath started on 4/30/2021, just after arthroscopy of RLE on 4/28/2021.
41 2021-05-18 blood clot Blood clot in neck; Shortness of breath (dyspnea); Pressure on her chest; Edema to her feet; Weight ... Read more
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.
41 2021-05-19 blood clot Heavy uterine bleeding and clotting
41 2021-05-22 blood clot Developed a blood clot. Symptoms presented by 03/05/21 (palpable bump behind left knee). By 03./07... Read more
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).
41 2021-05-23 vaginal haemorrhage Vaginal bleeding
41 2021-06-06 blood clot After 2nd dose, about 24 hours later my period started (I?m about 4 days early). I usually have extr... Read more
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.
41 2021-06-08 deep vein blood clot blood clots were found in my right leg, 6 to be exact, no known origin of the clots. Had a stent pla... Read more
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.
41 2021-06-08 blood clot in lung About a month and 20 days after my second vaccine I had trouble breathing. I work in the hospital, s... Read more
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.
41 2021-06-26 fluid around the heart After vaccine on 4/18/2021, major chest pain, shortness of breath, fatigue and sweats began. 4/22/20... Read more
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.
41 2021-07-01 low blood platelet count Platelets of 19, Idiopathic thrombocytopenic purpura
41 2021-07-01 transient ischaemic attack On May 27, 2021 at 9:20am, I experienced drooping of the right side of my face, weakness in my right... Read more
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).
41 2021-07-03 anaphylactic shock About an hour after I got vaccinated, I started to go into anaphylactic shock. My throat started to ... Read more
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.
41 2021-07-14 cardiac arrest, pulmonary embolism, deep vein blood clot On April 10th, I developed unprovoked pain in my lower left calf. I went to my primary doctor April ... Read more
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
41 2021-07-18 pulmonary embolism Pulmonary Embolism Blood Thinners
41 2021-07-21 pulmonary embolism, deep vein blood clot DVT and PE
41 2021-07-22 deep vein blood clot acute DVT in Left leg, has bilat leg pain
41 2021-07-27 anaphylactic reaction Anaphalactic Reaction treated by double dose of hydroxyzine on site at clinic. Throat swelling - ha... Read more
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.
41 2021-07-27 vaginal haemorrhage She was calling to see if she could get more info about side effects she is experiencing.; eye twitc... Read more
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
42 2020-12-31 atrial fibrillation Rapid heart rate, arrhythmia felt at 7pm 12/30, still present in morning 12/31/20, at 7:00 am was fo... Read more
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.
42 2021-01-07 anaphylactic reaction Started with hives approximately 15 minutes after and then went into full Anaphylaxis. Required epi ... Read more
Started with hives approximately 15 minutes after and then went into full Anaphylaxis. Required epi and Benadryl.
42 2021-01-07 excessive bleeding Bleeding, Myalgia, tingling in the fingers of the right hand; fatigue Immediately upon vaccination -... Read more
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.
42 2021-01-10 excessive bleeding Headache, Bleeding, Myalgia, Arthralgia, Angioedema, Sweats/Chills with normal temperature, ipsilat... Read more
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.
42 2021-01-22 anaphylactic reaction Patient was under the 15 minute post-vaccination observation period when she presented with signs an... Read more
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.
42 2021-01-26 anaphylactic reaction Systemic: Anaphylaxis-Severe
42 2021-02-08 anaphylactic reaction anaphylactic reaction; not able to breathe or talk; Her throat was closing up; This is a spontaneous... Read more
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.
42 2021-02-15 cerebrovascular accident Vaccine given 1-6-21, patient had a stroke left occluded carotid with dissection 1-11-21, no risk fa... Read more
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.
42 2021-02-21 heart attack Two days after the 2nd injection I started to have chest pain and not feel right. I went to the Stat... Read more
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.
42 2021-02-22 vaginal haemorrhage Vaginal bleeding about an hour after first dose
42 2021-02-23 anaphylactic reaction anaphylactic reaction; Flush face with itching; Flush face with itching; throat became itchy; tongue... Read more
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.
42 2021-02-24 ischaemic stroke Ischemic stroke
42 2021-03-15 pulmonary embolism, fluid around the heart n/v, chills, SOB, pulmonary embolism, pericardial effusion
42 2021-03-18 anaphylactic reaction Patient was determined to have an anaphylactic reaction by MD's on site. Benadryl was administered, ... Read more
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.
42 2021-03-18 vaginal haemorrhage Approximately one hour after receiving the vaccine, I had light vaginal spotting. Within a few hours... Read more
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.
42 2021-03-19 pulmonary embolism, deep vein blood clot Patient had calf swelling and then more after Covid Vaccine. Patient then had SOB. Patients primary ... Read more
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.
42 2021-03-21 cardiac arrest Miscarriage; Heart stopped on pregnancy; This is a spontaneous report from a contactable consumer (p... Read more
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.
42 2021-03-22 anaphylactic reaction Patient received dose at a clinic provided by store pharmacy at 9:30 AM on 2-25-2021. Patient stated... Read more
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.
42 2021-03-22 pulmonary embolism Pulmonary Emboli, shortness of breath
42 2021-03-22 vaginal haemorrhage Irregular vaginal bleeding & menstrual type cramps. Started approximately 48 hours after receiving v... Read more
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.
42 2021-04-02 blood clot, pulmonary embolism 10 days after my first shot my feet were swollen and I didn't feel well by 18 days after it was not... Read more
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.
42 2021-04-09 vaginal haemorrhage Vaginal bleeding and cramping similar to menstruation the same night as second dose was administered... Read more
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.
42 2021-04-12 blood clot Three days after receiving the vaccine, I developed a blood clot in the lining of my stomach.; This ... Read more
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.
42 2021-04-13 brain sinus blood clot, cerebrovascular accident I was admitted to ER with stroke and right arm weakness. While I was in the ER, I also developed ... Read more
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.
42 2021-04-14 death, pulmonary embolism Patient at 27 weeks of pregnancy, reported to midwife at regular visit on 4/14/21 that she was exper... Read more
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.
42 2021-04-14 excessive bleeding Subdural Hematoma. Blood bleed
42 2021-04-17 blood clot Hospitalized for what was determined with Guillain Barre -Miller Fischer Syndrome. Symptoms slowly ... Read more
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
42 2021-04-21 pulmonary embolism Diagnosed with bilateral pulmonary embolism 16 days after second Pfizer covid dose.
42 2021-04-24 anaphylactic reaction Anaphylactic reaction to vaccine; Felt like an elephant was sitting on my chest; Could not take a de... Read more
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.
42 2021-04-24 grand mal seizure Patient received 1st dose of Pfizer Covid vaccine on 4/21, and on 4/22 had 2 generalized tonic cloni... Read more
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)
42 2021-04-25 blood clot Heavier period than normal, bigger blood clots expelled
42 2021-04-25 blood clot 1 week after injection I developed superficial blood clots in my Left Calf, that still have not reso... Read more
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.
42 2021-04-27 deep vein blood clot, pulmonary embolism DVT; PE; This is a spontaneous report from a contactable physician. A 42-year-old female patient rec... Read more
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.
42 2021-04-30 anaphylactic reaction Began with hives on hands and neck area 3 days after covid vaccine, I took benadryl before bed and ... Read more
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.
42 2021-05-03 heart attack fibromuscular dysplasia; 3 artery dissections; narrowing of other arteries; chills; aches; fever 101... Read more
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.
42 2021-05-03 respiratory arrest, cardiac arrest After taking normal medications prior to bed became acutely short of breath, mother states patients... Read more
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.
42 2021-05-04 pulmonary embolism Hospitalized 18Apr2021 with bilateral Pulmonary embolism; This is a spontaneous report received from... Read more
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.
42 2021-05-05 blood clot Injection site tenderness, flu-like symptoms including headache, low grade fever, muscle and joint a... Read more
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.
42 2021-05-06 pulmonary embolism, deep vein blood clot Passed out on May 1 2021 admitted into hospital with saddle bag pe and dvt
42 2021-05-07 anaphylactic reaction flu-like symptoms; given an injection of steroids/difficulty breathing; difficulty breathing; fever ... Read more
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.
42 2021-05-08 death She began having shortness of breath after getting her second shot. He parents found her dead in her... Read more
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.
42 2021-05-10 blood clot Blood clot in right calf; This is a spontaneous report received from contactable consumer for hersel... Read more
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.
42 2021-05-19 pulmonary embolism pulmonary embolus; This is a spontaneous report from a contactable consumer (patient). A 42-year-old... Read more
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.
42 2021-05-21 grand mal seizure Chills, body aches, shakiness, twitching in my hands & feet, feeling of restless leg syndrome, incre... Read more
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
42 2021-05-23 vaginal haemorrhage, blood clot Severe vaginal bleeding not in line with the normal menstrual cycle. An extreme number of nickel-si... Read more
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.
42 2021-05-26 vaginal haemorrhage bleeding; This is a spontaneous report from a contactable consumer (patient). A 42-year-old not preg... Read more
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.
42 2021-05-29 heart attack Admitted to the hospital for 5 days after ER visit. Had a heart attack. Was diagnosed with spontaneo... Read more
Admitted to the hospital for 5 days after ER visit. Had a heart attack. Was diagnosed with spontaneous coronary artery dissection.
42 2021-06-01 blood clot Bruises on my thighs, looks like blood clots; Bruises on my thighs, looks like blood clots; This is ... Read more
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.
42 2021-06-05 cerebrovascular accident Event - stroke without known precursors Treatment- currently in inpatient rehab Outcome - unknown if... Read more
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
42 2021-06-06 anaphylactic reaction Anaphylaxis sharp pain left side by chest swelling in nape of neck by thyroid extreme sinus pressur... Read more
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
42 2021-06-07 blood clot PATIENT DEVELOPED SEVERE ABDOMINAL PAIN, N/V, FEELING FAINT LESS THAN 24 HOURS AFTER ADMINISTRATION ... Read more
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.
42 2021-06-12 low platelet count Extreme Thrombocytopenia (below 30,000) manifesting in bruising on arms, legs, torso, bleeding gums,... Read more
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.
42 2021-06-16 excessive bleeding The next day after the vaccination at 3:00 PM, I felt bone pain, tiredness, with a fever and that la... Read more
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.
42 2021-06-22 blood clot Nearly passed out twice; Passing blood clots; GI bleed; Severe body aches; Fatigue; Abdominal pain; ... Read more
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.
42 2021-06-23 cardiac arrest, death Experienced shortness of breathe resulting in death cardiac arrest.
42 2021-06-24 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-... Read more
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.
42 2021-06-27 pulmonary embolism pulmonary embolism. Felt sluggish and strange for a week and then had MRI on 3/4 and it was on MRI.
42 2021-06-29 pneumonia My hypertension was under control and got higher after the first shot. Went to my regular doctor fo... Read more
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.
42 2021-07-08 anaphylactic shock Hives swollen face and got anaphylactic shock bith both 1 and 2 series of pfizer vaccine Also got p... Read more
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
42 2021-07-14 cerebrovascular accident, blood clot I had stroke on March 8th - I was teaching from home and I got super dizzy; I could see in front of ... Read more
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.
42 2021-07-18 vaginal haemorrhage Well I had no other symptoms, no fever no day after problems like people say they have. I started sp... Read more
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.
42 2021-07-19 vaginal haemorrhage At the time of the 1st pfizer vaccine shot, I was 5 weeks 4 days pregnant. I had no issues with the... Read more
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.
42 2021-07-24 cerebrovascular accident April 9th at 07.50 in the morning I had a acute left middle cerebral artery stroke. Paralyzed on all... Read more
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
42 2021-07-26 deep vein blood clot Pfizer-BioNTech COVID-19 Vaccine: patient presented to emergency department 22 days after first immu... Read more
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.
42 2021-07-27 vaginal haemorrhage Early vaginal bleeding; having some cramping; This is a spontaneous report from a contactable Other ... Read more
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.
43 2020-12-31 blood clot Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge bl... Read more
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
43 2021-01-06 anaphylactic reaction anaphylactic reaction 2 hours post vaccine, given 2 rounds of epi in the ED in addition to allergic ... Read more
anaphylactic reaction 2 hours post vaccine, given 2 rounds of epi in the ED in addition to allergic reaction meds, still with rash.
43 2021-01-11 anaphylactic reaction first day after shot, nausea, body aches, 2nd day Sunday headache, Monday 5 am woke up itching, the... Read more
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
43 2021-01-12 anaphylactic shock I received my covid vaccine on 12/29/2020 at 4:42pm. In 10 minutes after the shot, I went into anap... Read more
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
43 2021-01-14 anaphylactic reaction Immediate itching and hives. Progressed quickly into anaphylaxis - stridor, difficulty breathing. Ta... Read more
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.
43 2021-01-14 anaphylactic reaction 5 minutes after receiving dose 2 of Pfizer COVID-19 vaccine started getting hives rash shortness of ... Read more
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
43 2021-01-14 deep vein blood clot Hospital Course:   Patient is a 43 y.o. female patient who originally presented to the hospital on... Read more
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.
43 2021-01-18 cerebrovascular accident Hospitalized for stroke on 31Dec two days after vaccine.; sudden loss of hearing to right ear; dizzy... Read more
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.
43 2021-01-19 anaphylactic reaction Started itching within (left arm) 15 minutes. THey said I was fine and to go back to work. About an ... Read more
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.
43 2021-01-27 anaphylactic reaction dyspnea, anaphalaxis
43 2021-02-02 anaphylactic reaction Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically res... Read more
Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically respiratory distress with stridor, nausea, and generalized abdominal pain.
43 2021-02-04 anaphylactic reaction 15 minutes after first Pfizer Covid injection, pt developed itchy throat, given benadryl 50 po and m... Read more
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
43 2021-02-04 excessive bleeding I was approximately 4 weeks pregnant at the time that I received dose #1 (12/23/20)- I was unaware o... Read more
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.
43 2021-02-09 vaginal haemorrhage I was a healthy pregnant woman age 43 who was 11 weeks 2 days pregnant. I was having a normal pregn... Read more
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
43 2021-02-17 vaginal haemorrhage I didn?t notice any symptoms right away. When they started, I didn?t think it was abnormal at first... Read more
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.
43 2021-02-19 vaginal haemorrhage 8 hours after the shot= all my joints hurt. Joints that normally do not hurt did like my neck joint,... Read more
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.
43 2021-02-20 vaginal haemorrhage I was 5-week pregnant at the time of second COVID-19 vaccine dose. I had a gush of yellow vaginal di... Read more
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.
43 2021-02-21 vaginal haemorrhage On 2/20/21 when I woke up I went to use the restroom. When I wiped I noticed that I was spotting on... Read more
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.
43 2021-02-23 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe
43 2021-02-26 vaginal haemorrhage Received 1st vaccine at 3weeks, 2nd vaccine at 6 weeks, at 7 weeks saw baby and heart beat at 9 w5 d... Read more
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.
43 2021-03-02 anaphylactic reaction Itching throat; cough; Taste and smell loss; Taste and smell loss; Taste and smell loss; mild anaphy... Read more
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.
43 2021-03-09 anaphylactic reaction Anaphylactic reaction, splotchy skin
43 2021-03-14 anaphylactic reaction Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing... Read more
Anaphylaxis: Closing throat, swollen mouth, sore throat, difficulty swallowing, difficulty breathing deeply, itchiness in mouth, blotching of skin
43 2021-03-14 deep vein blood clot, pulmonary embolism Starting on February 24, 2021, I started to have shortness of breath. This slowly got worse until on... Read more
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.
43 2021-04-01 acute respiratory failure Patient was a 43 yo F who presented to ED on 12/25/2020 with complaints of worsening shortness of br... Read more
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.
43 2021-04-03 excessive bleeding Pfizer dose 1 - left arm hurt for 3 days - used ice pack and Advil to ease Pfizer dose 2 - started b... Read more
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).
43 2021-04-07 atrial fibrillation Could feel that I went into AFIB about 10 minutes after shot administration. Nearly 5 hours later a... Read more
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.
43 2021-04-11 anaphylactic reaction Anaphylaxis, acute respiratory distress, mild tongue edema
43 2021-04-14 anaphylactic reaction Mild/moderate anaphylactic reaction lasting about 45 minutes, trouble swallowing, fast pulse, disori... Read more
Mild/moderate anaphylactic reaction lasting about 45 minutes, trouble swallowing, fast pulse, disorientation, tight throat. Epinephrine not used.
43 2021-04-14 cardiac arrest I got the shot on Friday then had a low grade fever on Saturday, was fine until Tuesday, 3/30, when ... Read more
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.
43 2021-04-15 transient ischaemic attack Was talking with husband and commented that I felt a wave of tired coming over me. Immediately follo... Read more
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.
43 2021-04-15 transient ischaemic attack Patient developed L sided weakness and numbness on 4/15/21, and was found to have a transient ischem... Read more
Patient developed L sided weakness and numbness on 4/15/21, and was found to have a transient ischemic attack.
43 2021-04-19 anaphylactic reaction Went to doctor diagnosed with anaphylactic angioedema.
43 2021-04-20 vaginal haemorrhage Started cramping about an hour after. Then 2 hours later started having bright red breakthrough vagi... Read more
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.
43 2021-04-23 blood clot I passed a number of large blood clots (the size of a walnut) from my body on the two days after I r... Read more
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.
43 2021-04-24 excessive bleeding bleeding; have not had a period in four years, five days after my second shot and I am having terrib... Read more
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.
43 2021-04-28 blood clot The day after the vaccine I experienced brain fog, fatigue, and sore arm. I also got my period. I ha... Read more
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.
43 2021-04-30 deep vein blood clot, blood clot, cerebrovascular accident problem with her cholesterol; pain on the top of my head and my hands hurt/headache; pain on the top... Read more
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.
43 2021-05-06 blood clot First shot 12/23, 2nd 1/12/21. A week after #2 my menstrual cycles (which have been clockwork all of... Read more
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.
43 2021-05-07 excessive bleeding Currently 4 days of bleeding; increased energy; sore left arm; overly emotional cry ie for a couple/... Read more
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.
43 2021-05-07 bleeding on surface of brain Subarachnoid hemorrhage. Was in icu from 4/8/2021 until 4/15/2021
43 2021-05-11 fluid around the heart breathing labored while walking or doing activity; swollen lymph nodes/ lymph nodes were enlarged sl... Read more
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.
43 2021-05-12 pulmonary embolism Shortness of breath and pain in left abdomen. CT scan on 3/27/21 showed the following: Bilateral seg... Read more
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.
43 2021-05-16 heart attack Received the Pfizer 2nd dose on 9th April. Following day (04/10), I had body ache, fatigue, mild tem... Read more
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.
43 2021-05-16 vaginal haemorrhage Vaginal hemorrhage 5 days after 2nd Pfizer dose on 1/16/21. Very heavy menstruation on 1/21/21 with... Read more
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.
43 2021-05-19 deep vein blood clot Started with the right arm turning purple or changing colors when elevated above the head. This co... Read more
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.
43 2021-05-25 deep vein blood clot ON 01/19/2021, I HAD A SHARP PAIN IN MY LEFT CALF WHICH FELT LIKE A MUSCLE SPASM. FOLLOWING THIS I ... Read more
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.
43 2021-05-25 heart attack Pt presented with angina, inital troponin normal, then rose to 5.2. Ck-MB and MB index also rose and... Read more
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.
43 2021-06-02 pulmonary embolism, deep vein blood clot DVT (right leg) found 05/19 and PE found 05/21
43 2021-06-06 excessive bleeding I experienced a muscle tension and neuroprosy. I have internal trimmers and he external arm trimmers... Read more
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.
43 2021-06-07 pneumonia fatigue for a few days. She went to Urgent care on 4/24 where she tested (+) for COVID. Went to ho... Read more
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.
43 2021-06-09 blood clot in lung I was dizzy and I checked my bp and it was 70/40 i stopped talking my bp meds, drank water and my Bp... Read more
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.
43 2021-06-09 ventricular tachycardia I am a healthy 43-year-old woman with no major medical problems and no history of cardiac disease of... Read more
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.
43 2021-06-10 blood clot, heart attack Extreme fatigue, heart pains, dizziness,foggy head, heart attack, blood clots and the list goes on
43 2021-06-21 blood clot One hour after the vaccine I had headache, my feet were sweating, a little of wheezing and experienc... Read more
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.
43 2021-06-23 low platelet count, stroke Patient was admitted to the hospital 4 days after the dose with gram negative bacteremia from a port... Read more
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.
43 2021-06-24 brain sinus blood clot Blood Clot in brain Dural Sinus Thrombosis
43 2021-06-24 bleeding on surface of brain Sudden onset headache accompanied with nausea and vomiting around noon. ER visit MRI showed grade 1 ... Read more
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.
43 2021-06-26 death, heart failure Started with body aches, joint pain and weakness, followed by SOB that was aggravated over time- esp... Read more
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.
43 2021-06-27 heart attack 8pm to 12am Chest pain and heart attack with no other cardiac history or risk factors. Evaluated at... Read more
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.
43 2021-07-10 deep vein blood clot DVT - blood clot, found in left leg. Symptom, leg pain, diagnosed via ultrasound at hospital , Lov... Read more
DVT - blood clot, found in left leg. Symptom, leg pain, diagnosed via ultrasound at hospital , Lovenox and Pradaxa
43 2021-07-10 blood clot, brain sinus blood clot a blood clot in the brain; Dural sinus thrombosis; This is a spontaneous report from a contactable c... Read more
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.
43 2021-07-19 vaginal haemorrhage Abnormal uterine and vaginal bleeding, unspecified
43 2021-07-25 pneumonia, acute respiratory failure Witnessed seizure at 7:30 pm EDT on May 2, 2021. No prior medical problems. Serum sodium dropped t... Read more
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.
43 2021-07-25 blood clot Starting the day after the vaccine, I had about four days of fever to 102-103, and malaise and tired... Read more
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.
44 2021-01-04 anaphylactic reaction Anaphylactic Reaction, facial swelling, facial Redness, Face felt like it was burning, face flushin... Read more
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
44 2021-01-10 low platelet count 1/6/21 8pm started with Nasuea, vomiting, diarrhea and fever. 1/7/21 started having intermittent che... Read more
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.
44 2021-01-11 death unsure if related to vaccine, but was notified by her next of kin that she died on 1/4/2021. No rep... Read more
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.
44 2021-01-12 anaphylactic reaction Moderate anaphylaxis reaction per urgent care provider. Developed severe hives and swelling, fever, ... Read more
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.
44 2021-01-13 pneumonia 12/23/20 - RECEIVED 1ST DOSE OF COVID-19 VACCINE IN AM FROM EMPLOYEE HEALTH CLINIC 12/24/20 EVENING ... Read more
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
44 2021-01-18 deep vein blood clot Visited Provider appx 500 pm 1.14.2021 DVT - left calf - 2 clots via ultrasound on Eliquis no... Read more
Visited Provider appx 500 pm 1.14.2021 DVT - left calf - 2 clots via ultrasound on Eliquis now
44 2021-01-19 anaphylactic reaction Systemic: Anaphylaxis, Systemic: Seizure-Severe
44 2021-01-21 grand mal seizure Two grand mal seizures and went unconscious. Prior to seizures felt very lethargic.
44 2021-02-08 anaphylactic reaction Provider stated patient had anaphylaxis (facial swelling) at around 2:16, 1 dose epi pen was adminis... Read more
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
44 2021-02-19 heart attack Patient suffered a heart attack on 2/17/2021
44 2021-02-19 vaginal haemorrhage Abnormal menstrual cycle pattern. 3 days of spotting after the first injection. Currently 15 days of... Read more
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.
44 2021-02-22 cerebrovascular accident Dizziness; stoke like symptoms; lost taste; Lost smell; lost hearing; weakness; right eye droopy; Th... Read more
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.
44 2021-02-28 pulmonary embolism Pt presented to ED 45 minutes after receiving 1st dose Pfizer COVID vaccine with elevated BP, itchin... Read more
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.
44 2021-03-02 anaphylactic reaction Severe anaphylaxis attack; feeling tired; tachycardia; tingling sensation; sweating; feeling hot; BP... Read more
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.
44 2021-03-02 heart attack, blood clot very high Troponin levels (4.79 & 12.49); repeat episodes of chest pain; heart attack; thrombus form... Read more
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.
44 2021-03-12 anaphylactic reaction Pt walked up to staff c/o itchy & swelling to throat & tongue. Staff assessed pt & vitals. Pt presen... Read more
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.
44 2021-03-13 blood clot Woke up with sore upper right thigh Tuesday March 9. Very tender to the touch. Visited Dr. Wednesday... Read more
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.
44 2021-03-13 vaginal haemorrhage Extended Vaginal Bleeding
44 2021-03-14 pneumonia I thought was a sinus infection exp wheezing, headache, achiness. By week two went to ER got tested ... Read more
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.
44 2021-03-14 blood clot First Vaccine Dose on 12/26/2020 felt extremely fatigued. After 2nd vaccine dose on 01/16/2021 devel... Read more
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.
44 2021-03-20 vaginal haemorrhage Vaginal bleeding beginning immediately after first shot. 2 days after second shot vey heavy/hemorrha... Read more
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.
44 2021-03-25 anaphylactic reaction Anaphylaxis: Shortness of breath, chest tightness, itching, muscle spasm
44 2021-03-26 anaphylactic reaction Immediate metallic taste in the mouth. Anaphylactic reaction starting after 5 minutes (high heart ra... Read more
Immediate metallic taste in the mouth. Anaphylactic reaction starting after 5 minutes (high heart rate, difficulty swallowing, tight feeling in chest).
44 2021-03-30 anaphylactic reaction Anaphylaxis; This is a spontaneous report from a two contactable consumer (patient and office assist... Read more
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.
44 2021-03-30 anaphylactic reaction 20 minutes after injection, started feeling itchy all over. Began coughing and having asthma, used i... Read more
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.
44 2021-04-01 anaphylactic reaction Patient presents 1 day after anaphylactic reaction (throat swelling, congestion, hives, nausea, SOB)... Read more
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.
44 2021-04-03 vaginal haemorrhage Slight vaginal bleeding 2 days after receiving the first dose of the vaccine (1 bleeding only) On th... Read more
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)
44 2021-04-04 excessive bleeding, vaginal haemorrhage 24 hours after receiving the 1st dose vaccine I suffered from abdominal pain/cramping and vaginal bl... Read more
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.
44 2021-04-04 vaginal haemorrhage, excessive bleeding Abnormal Vaginal Bleeding
44 2021-04-06 anaphylactic reaction Vaccine administered around 0850, approximately at 0854 patient notified provider with symptoms of a... Read more
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.
44 2021-04-07 blood clot DEVELOPED BLOOD CLOT IN RIGHT BREAST - CURRENTLY BEING TREATED
44 2021-04-09 low platelet count nausea; vomiting; chest pain; myocarditis; thrombocytopenia; This is a Literature-spontaneous report... Read more
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.
44 2021-04-09 blood clot, pulmonary embolism, cardio-respiratory arrest Pulmonary Embolism. Emergency open heart surgery. Coded for 4 minutes. In ICU and Hospital. Kidney f... Read more
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.
44 2021-04-09 vaginal haemorrhage About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went comple... Read more
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.
44 2021-04-12 blood clot Blood clot. Right leg. Treatment Lovenox injections and Pradaxa blood thinner medication. Time on... Read more
Blood clot. Right leg. Treatment Lovenox injections and Pradaxa blood thinner medication. Time on Pradaxa to be determined on resolution of blood clot.
44 2021-04-13 blood clot, excessive bleeding Hemorrhage like bleeding, soaked up 4 maxi pads within a 30 minute span. Expelled Blood clots the s... Read more
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.
44 2021-04-15 anaphylactic reaction What: Anaphylaxis reaction. Vaccine administered around 0850, approximately at 0854 patient notified... Read more
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.
44 2021-04-15 blood clot Developed a 7mm Blood Clot
44 2021-04-17 anaphylactic reaction Itching all over, coughing, asthma, anaphylaxis; Itching all over, coughing, asthma, anaphylaxis; It... Read more
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.
44 2021-04-17 blood clot, pulmonary embolism massive clots; Pulmonary Embolisms; Occluded Left Lung, Right Ventricle; Occluded Left Lung, Right V... Read more
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.
44 2021-04-18 grand mal seizure I had a seizure and fell out of bed between the night of March 12th and the morning of March 13, 202... Read more
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.
44 2021-04-20 cerebrovascular accident left sided hemiplegia, found down 4/20 @3:30pm, found to have left ICA territory stroke with M1 occl... Read more
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
44 2021-04-20 blood clot I started having right leg swelling. I noticed a small red spot on my medial side of my knee. I had ... Read more
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.
44 2021-04-21 blood clot Changes in menstrual cycles including heavy bleeding, large blood clots, longer cycles, and spotting... Read more
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).
44 2021-04-22 anaphylactic reaction Patient received first dose of Pfizer COVID-19 vaccine on 1/21 at 1011. She presented to the ED that... Read more
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.
44 2021-04-27 blood clot 1/28/2021-swollen lymph nodes and pain to left side of chest and injection site. This pain continued... Read more
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).
44 2021-05-02 anaphylactic reaction Pt presented to ER 1 hour after receipt of 2nd Pfizer vaccine, presenting with angioedema/anaphylaxi... Read more
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.
44 2021-05-04 anaphylactic reaction Morning of April 03, 2021 I woke up with swollen, itchy, burning eyes and pain in hands. I took an A... Read more
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
44 2021-05-04 low platelet count Thrombocytopenia detected through monitoring CBC. Normal platelet counts for 5+ years Normal pla... Read more
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
44 2021-05-05 pneumonia Pneumonia due to COVID-19 virus ; Had a lot of headaches; Had agitation/palpitations; Had muscle cra... Read more
Pneumonia due to COVID-19 virus ; Had a lot of headaches; Had agitation/palpitations; Had muscle cramps; Hydroxyzine HCL; Amoxicillin; Acetaminophen.
44 2021-05-10 grand mal seizure Within less than 36 hours after receiving the 1st dose pf the Pfizer Vaccine, I suffered a Grand Mal... Read more
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
44 2021-05-10 low platelet count Same evening immunization felt hives and wheezing (4/15) which lasted through 4/17. Then on 4/18 st... Read more
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.
44 2021-05-11 anaphylactic reaction pt received 1st pfizer covid shot at 3:47 pm. she told me she had a history of anaphylaxis to oral b... Read more
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.
44 2021-05-11 deep vein blood clot unprovoked DVT of Right lower leg; This is a spontaneous report from a contactable physician. A 44-y... Read more
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.
44 2021-05-12 anaphylactic reaction 20 minuted after getting my second dose I started having an anaphylaxis reaction. My throat became i... Read more
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.
44 2021-05-12 excessive bleeding Immediate exhaustion Insane food cravings ( I never crave anything); followed by unprecedented blood... Read more
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.
44 2021-05-14 anaphylactic reaction blacked out; delayed anaphylactic reaction; Tongue Swelled; Couldn't swallow; Couldn't breathe right... Read more
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).
44 2021-05-15 vaginal haemorrhage I started bleeding vaginally 2 days after the first dose but it was time for my period so I didn?t t... Read more
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.
44 2021-05-16 stroke On the afternoon of 2/5/21 I developed dizziness, right hand numbness/weakness, difficulty speaking ... Read more
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)
44 2021-05-17 low blood platelet count, low platelet count ITP - platelets of 3; severe thrombocytpenia; This is a spontaneous report from a contactable physic... Read more
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.
44 2021-05-19 blood clot pt says she had a hot red swollen right leg that was very painful. On 4/16/21 she went to the Hospi... Read more
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.
44 2021-05-26 blood clot in lung Started with chills, fever, body aches, shortness of breath and headache for about 36 hours. The sh... Read more
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.
44 2021-05-27 anaphylactic reaction, excessive bleeding have had off and on spotty bleeding but no monthly period; ringing in her ears; nausea; fever; eat h... Read more
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.
44 2021-05-28 excessive bleeding bleeding; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-preg... Read more
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.
44 2021-06-03 cardiac failure congestive SHORTNESS OF BREATH, SEVERE FATIGUE, ENDED UP IN HOSPITAL DIAGNOSED WITH CHF
44 2021-06-05 blood clot, stroke, cerebrovascular accident Developed a R ICA acute thrombus (seen on CTA) and arrived with significant left sided weakness as ... Read more
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.
44 2021-06-08 ischaemic stroke Headache, falling to ground, passing out going to ER. They did an mri which showed I had an ischem... Read more
Headache, falling to ground, passing out going to ER. They did an mri which showed I had an ischemic stroke.
44 2021-06-08 severe muscle breakdown May 28, 2021: post 2nd vaccine: muscle pain, stiffness, swelling.
44 2021-06-08 blood clot Anytime I exerted myself it get worse so I went to the hospital and they admitted me because they co... Read more
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.
44 2021-06-09 fluid around the heart Acute pericarditis (confirmed by ECG, Echocardiogram and cardiology consultation), 1 week after seco... Read more
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.
44 2021-06-11 deep vein blood clot, pulmonary embolism Patient presented to hospital on 5/28/21 after 1 week of right lower extremity swelling and shortnes... Read more
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.
44 2021-06-13 pulmonary embolism, deep vein blood clot On June 8, 2021 I noticed right shoulder/arm pain. Went to my dr on 6/9 and he ordered a port dye st... Read more
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.
44 2021-06-13 blood clot large blood clot in right leg/groin, xarelto po, consult hematologist and vascular surgeon, still wa... Read more
large blood clot in right leg/groin, xarelto po, consult hematologist and vascular surgeon, still waiting for treatment to resolve blood clot
44 2021-06-15 anaphylactic reaction Patient had a reaction to the Pfizer vaccine. Patient complained of itchy throat, puffy eyelids, an... Read more
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.
44 2021-06-21 blood clot On the eve of the vaccine, I felt a lot of pans shooting from vaccination sight down arm, felt fever... Read more
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.
44 2021-07-13 excessive bleeding Tiredness Headache Muscle pain Chills Fever Nausea Diarrhea before going to hospital all day and at ... Read more
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
44 2021-07-13 pneumonia Despite completing COVID19 vaccine series in March, the oatient developed bodyaches, headache, conge... Read more
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.
44 2021-07-17 pneumonia COVID-19 confirmed by positive COVID-19 test; thought she had pneumonia or bronchitis; Caller states... Read more
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.
45 2020-12-31 anaphylactic reaction Anaphylaxis, allergic reaction: Throat swelling, facial and ear numbness on left side. Ear redness a... Read more
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.
45 2021-01-14 low platelet count COVID 19 vaccine - unsure which vaccination Flu like symptoms for 1 day with noted thrombocytopenia... Read more
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
45 2021-01-17 anaphylactic reaction Itching, rash, hives, difficulty breathing, difficulty swallowing, anaphylactic response. Treatment... Read more
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
45 2021-01-25 vaginal haemorrhage vaginal bleeding; This is a spontaneous report from a contactable nurse (patient) via Medical inform... Read more
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.
45 2021-01-31 vaginal haemorrhage Patient developed fever of 103 and body aches the evening of her vaccination, and continued with fev... Read more
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.
45 2021-02-04 cardio-respiratory arrest, death, cardiac arrest In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicate... Read more
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.
45 2021-02-07 cerebrovascular accident Employee reports having a stroke 2 weeks after vaccination that required hospitalization.
45 2021-02-09 vaginal haemorrhage ~9 days of vaginal spotting (in between menses), and several mild nosebleeds.
45 2021-02-19 anaphylactic reaction While sitting in the waiting area I began to feel itchy. it was around 7:50am. I quickly took 2 chew... Read more
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.
45 2021-02-24 fluid around the heart starting that evening, I had fever to 101, headache, heartburn and diarrhea for about 30 hours. on ... Read more
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.
45 2021-03-02 grand mal seizure Patient DOB 9/21/75 sustained witnessed tonic/clonic seizure like activity with loss of consciousnes... Read more
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
45 2021-03-04 severe muscle breakdown Onset of weight gain, lower extremity swelling 2/24/2021. Labs completed 3/1/2021, diagnosed with mi... Read more
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.
45 2021-03-17 deep vein blood clot, pulmonary embolism, blood clot Development of DVT of right leg and PE of right lung. Leg pain started on Friday 01/15/21. Care so... Read more
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.
45 2021-03-18 deep vein blood clot two weeks after vaccination, pt developed significant DVT throughout venous system of leg. Had bee... Read more
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
45 2021-03-21 anaphylactic reaction anaphalaxis, epicene, benadryl, pepsid
45 2021-03-26 pulmonary embolism I had my second vaccine on Monday, 3/22, and woke up at 1am on Thursday 3/25 with extreme chest pain... Read more
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.
45 2021-03-30 deep vein blood clot Deep vein thrombosis in right calf; received bnt162b2, dose 2 on 15Jan2021/first dose on 29Dec2020; ... Read more
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.
45 2021-04-01 blood clot Patient complains of shortness of breath about 5-10 min after vaccine. BP was taken because patient ... Read more
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 2021-04-10 grand mal seizure 45 y/o F with PMHx of vasovagal with seizure c/o not feeling well around 1:14 pm (which was 14 minut... Read more
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
45 2021-04-10 blood clot PT STATES 4/7 AT 3PM SHE NOTICED SWELLING IN LEG AND WENT TO ER. DIAGNOSED AS SUPERFICIAL BLOOD CLOT... Read more
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.
45 2021-04-12 deep vein blood clot Patient received second Pfizer dose on 4/9 at 9:15 am. That evening she developed fever of 102.5 F w... Read more
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
45 2021-04-12 respiratory arrest Patient began to feel light headed after vaccine administration and then began to slur speech and sh... Read more
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.
45 2021-04-13 cerebrovascular accident Severe headaches and ear pain on right side of ear. She thought she was getting migraines (but hadn... Read more
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.
45 2021-04-13 blood clot, pulmonary embolism, excessive bleeding Blood clot in lower right leg (calf), resulting in pulmonary embolisms and use of blood thinners. D... Read more
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.
45 2021-04-15 vaginal haemorrhage Feeling nauseous, fatigues and vaginal spotting.
45 2021-04-17 vaginal haemorrhage I'm on my 3rd Mirena IUD and haven?t had a period or spotting in over 11 years, but started spotting... Read more
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.
45 2021-04-18 anaphylactic reaction 15 minutes after the injection I had an intense allergic/anaphylactic reaction. I was watched and t... Read more
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.
45 2021-04-19 ischaemic stroke 2 Ischemic strokes on right side of brain due to blood clots
45 2021-04-20 heart attack immune system was low; shingles; heart attack; This is a spontaneous report from a contactable consu... Read more
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.
45 2021-04-20 severe muscle breakdown Approximately 3 days after receiving the vaccine she developed bilateral lower extremity paralysis.
45 2021-04-20 blood clot I was having my menstrual cycle when I got my second vaccine. Approximately 24 hours after receiving... Read more
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.
45 2021-04-23 blood clot Severe menstrual bleeding with clotting causing severe anemia. Hemoglobin level 9. Received first do... Read more
Severe menstrual bleeding with clotting causing severe anemia. Hemoglobin level 9. Received first dose of Iron transfusion through IV yesterday on 4/23/2012
45 2021-04-28 cerebral haemorrhage As described by the patient: As they were putting the vaccine, the area got really warm, and the ar... Read more
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
45 2021-05-05 blood clot Immediate chest pain (tightening) , then arm pain while in store/pharmacy Next Day began spotting (m... Read more
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
45 2021-05-06 pneumonia All Covid symptoms returned. Tremors. Severe headache. Numbness in right side of face and body. Dizz... Read more
All Covid symptoms returned. Tremors. Severe headache. Numbness in right side of face and body. Dizzy. New was throat swell and tongue swelling.
45 2021-05-06 blood clot Had an additional mensural cycle with heavy clotting and cramping.
45 2021-05-07 pneumonia This is a spontaneous report from a contactable consumer reporting for self. A 45-years-old female... Read more
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.
45 2021-05-09 fluid around the heart Pt presented to Urgent Care on the third day after vaccine (5/9) with chest pain, left arm pain, nau... Read more
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.
45 2021-05-11 anaphylactic reaction Anaphylaxis Metal taste in mouth Numbing of face and lips
45 2021-05-18 death, blood clot in the brain, cerebrovascular accident Blood clot in brain causing stroke then death
45 2021-05-21 low blood platelet count I developed an ITP flare after receiving vaccine and my blood platelets dropped to as low as 7000.; ... Read more
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.
45 2021-05-21 bleeding on surface of brain I had a subarachnoid hemorrhage on 4/30/21. It was suspected to be caused by a ruptured aneurysm. I... Read more
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.
45 2021-05-26 death Death. Patient died on 5/3/2021; two days after receiving vaccine.
45 2021-05-26 deep vein blood clot, pulmonary embolism Massive pulmonary embolism resulting in syncope and hypoxia
45 2021-05-27 vaginal haemorrhage I haven't had my period for about 2 and a half years. I started bleeding vaginal on the 24th of May... Read more
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.
45 2021-05-31 heart attack PT had myocardial infarction 6 days after 2nd Pfizer dose
45 2021-05-31 pneumonia Fever, Severe Chest congestion w/ wheezing, severe headache, shortness of breath. Diagnosed with pne... Read more
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.
45 2021-06-01 deep vein blood clot lower extremity deep venous thrombosis
45 2021-06-01 pneumonia J18.9 - Pneumonia of right upper lobe due to infectious organism
45 2021-06-01 blood clot I started a very heavy period that lasted 25 days. I usually have a light 2 day period like clockwor... Read more
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.
45 2021-06-02 deep vein blood clot Right upper extremity DVT
45 2021-06-03 ischaemic stroke, blood clot PT STARTED EXPERIENCING INTENSE HEADACHES ON THE MORNING OF 5/21/2021. THE HEADACHES CONTINUED ON AN... Read more
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.
45 2021-06-06 anaphylactic reaction During our event today, here at the Church in coordination with the Cleaning Services monthly train... Read more
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.
45 2021-06-06 pneumonia J18.9 - Pneumonia, unspecified organism
45 2021-06-06 blood clot Ongoing migraine headaches that are not relieved. Loss of peripheral vision in left eye. Constant ea... Read more
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.
45 2021-06-06 blood clot Had 5 (periods instead of 3) in 3 months, one lasting 13 days. All were heavier and more blood clots... Read more
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.
45 2021-06-08 cardiac arrest, death Pt rec'd 2 doses Pfizer/BioNTech, 2nd dose May 9,2021 at outside facility. Presented to hospital on ... Read more
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.
45 2021-06-10 blood clot Started getting pain in my right leg on May 1st, seen my Family Dr. on 4/29/21 clean bill of health.... Read more
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.
45 2021-06-13 deep vein blood clot, pulmonary embolism Deep Vein Thrombosis, pulmonary embolism blood thinners no final outcome as I am still in treatment
45 2021-06-15 atrial fibrillation Case developed symptoms 06/08/2021. Hospitalized and tested positive for Covid-19 on 06/13/2021 at ... Read more
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.
45 2021-06-20 pneumonia Headache, swelling, neck pain, high temp fever, pneumonia, loss of state and smell, swelling of lymp... Read more
Headache, swelling, neck pain, high temp fever, pneumonia, loss of state and smell, swelling of lymph nodes.
45 2021-06-24 vaginal haemorrhage First Pfizer Dose was administered to patient via right arm injection at 3:00pm on June 24,2021. Aro... Read more
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.
45 2021-06-27 blood clot The pain in my arm post vaccination on 5.6.21 never fully went away. It got better for a couple we... Read more
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.
45 2021-06-28 heart attack I21.4 - Non-STEMI (non-ST elevated myocardial infarction) (CMS/HCC)
45 2021-06-28 pulmonary embolism, cardiac arrest 5/31/21 had back chest neck arm pain, went to medic, went into cardiac arrest, the did 18 minutes of... Read more
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.
45 2021-07-01 stroke, cerebrovascular accident ICA stroke; headache; earache; sinus issue; had sudden onset stroke symptoms while hiking; This is a... Read more
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.
45 2021-07-05 heart attack I21.4 - Non-ST elevation (NSTEMI) myocardial infarction ABDOMINAL PAIN VOMITING CHEST PAIN
45 2021-07-05 blood clot, deep vein blood clot About three weeks after I received my second Pfizer vaccine, I noticed pain in my upper left arm, ri... Read more
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.
45 2021-07-08 cerebrovascular accident I had a stroke sometime between 11pm on April 22, 2021 and 8am on April 23, 2021. I'd had the vacc... Read more
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.
45 2021-07-08 sepsis Right after 2nd shot for 4 hours after I had tachycardia up and down. Then almost 2 weeks later I go... Read more
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.
45 2021-07-11 heart attack, pulmonary embolism 5/31 patient developed chest pain while at work, presented to clinic at work. Had ECG changes, and M... Read more
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.
45 2021-07-11 deep vein blood clot Patient had left lower extremity pain x 4 days with left lower extremity swelling x 2 days. Patient ... Read more
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.
45 2021-07-12 blood clot Unexpected menorrhagia (heavy menstrual bleeding) with large (larger than half dollars) clots within... Read more
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.
45 2021-07-27 respiratory arrest, pneumonia I couldn't breathe or swallow. This started about 2 months after vaccination. I went to the ED and t... Read more
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.
46 2021-01-04 anaphylactic reaction Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of... Read more
Anaphylactic reaction ( swelling and redness of face and torso, shortness of breath, constriction of airway and dizziness)
46 2021-01-04 anaphylactic reaction Anaphylaxis Narrative: 12/22 received COVID-19 vaccine at 1209 and developed SOB at 12:15. Took her ... Read more
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.
46 2021-01-08 anaphylactic reaction Anaphylaxis throat felt like it was closing 15 minutes after getting vaccine Narrative: Employee ... Read more
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"
46 2021-01-18 respiratory failure Patient had received second Pfizer vaccination after no reported issues with the first dose. Patien... Read more
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
46 2021-01-20 anaphylactic reaction Systemic: Anaphylaxis-Severe
46 2021-01-30 deep vein blood clot Deep vein thrombosis right gastrocnemius vein and superficial venous thrombosis in right small saphe... Read more
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.
46 2021-02-03 vaginal haemorrhage 4 days post 2nd vaccine I started vaginal bleeding. Lasted 2 weeks. Bleeding stopped for a few day... Read more
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
46 2021-02-19 cerebrovascular accident 24-48 hours after receiving dose, had low grade fever, headache, and malaise. On Tuesday morning (3 ... Read more
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
46 2021-02-21 pulmonary embolism Patient was admitted s/p hysterectomy, found to have PE and AKI. Patient treated with heparin drip, ... Read more
Patient was admitted s/p hysterectomy, found to have PE and AKI. Patient treated with heparin drip, transitioned to Eliquis and discharged
46 2021-02-24 anaphylactic reaction Patient received the 2nd dose of the Covid-19 vaccine at 16:26 today (2/25/21). She reported symptom... Read more
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.
46 2021-03-01 death death
46 2021-03-01 vaginal haemorrhage sore feet; soaked; shortness of breath; had welts on toes; swollen feet; Both feet and hand joints h... Read more
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.
46 2021-03-09 pulmonary embolism, deep vein blood clot got vaccine - about a week later - she sent us a message saying "I have been having right calf pain ... Read more
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.
46 2021-03-11 sepsis patient administered vaccine at another facility and presented to this facilities ED on 2/24. Patie... Read more
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
46 2021-03-18 ventricular tachycardia Heart palpitations continued for 5-7 days after the shot.
46 2021-03-21 blood clot, low platelet count, excessive bleeding, respiratory failure severe thrombocytopenia; Bleeding at Impella insertion site; peripheral swelling in hands/feet; card... Read more
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.
46 2021-03-24 pulmonary embolism Shortness of breath, Diffuse Pulmonary Embolism with Ground glass opacities, happened over course of... Read more
Shortness of breath, Diffuse Pulmonary Embolism with Ground glass opacities, happened over course of 1 week
46 2021-03-25 heart attack, heart attack Vaccine administered 12/31/20. SCAD heart attack on 01/21/21.
46 2021-04-01 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: A... Read more
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.
46 2021-04-05 pulmonary embolism Evening of: Pain at injection sight (expected), pain down the left lung/torso area. Day 1 Post: Pain... Read more
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***
46 2021-04-05 low platelet count Thrombocytopenia Now 2 aneurism in brain Angio scheduled for 4/14/21
46 2021-04-06 vaginal haemorrhage 01/17/2021 Pain in Right opposite of the arm got vaccination in 01/18/2021 felt a lump and had spott... Read more
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.
46 2021-04-08 anaphylactic reaction Delayed anaphylaxis. Treated with diphenhydramine and albuterol at 90 minutes post vaccination, epin... Read more
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.
46 2021-04-08 pulmonary embolism I was diagnosed with a pulmonary embolism on 1/15/21
46 2021-04-09 anaphylactic reaction Was taken by ambulance diagnoses anaphylaxis Throat swelling itching you get swelling was released a... Read more
Was taken by ambulance diagnoses anaphylaxis Throat swelling itching you get swelling was released after 4 hours with meds given iv steroids iv Benadryl
46 2021-04-12 anaphylactic reaction skin hurting like a neuropathy; chills; she experienced a rash; My blood pressure was high; anaphyla... Read more
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.
46 2021-04-12 death, pulmonary embolism Massive PE, patient died. No history of DVT, we did a COVID test here and it was negative. She had ... Read more
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.
46 2021-04-12 deep vein blood clot DVT right leg began on evening of Feb 28 but became evident March 1 morning and diagnosed evening at... Read more
DVT right leg began on evening of Feb 28 but became evident March 1 morning and diagnosed evening at ER
46 2021-04-12 pulmonary embolism Went to ER and was diagnosed with bilateral pulmonary emboli; Pain on left lung/torso/Severe pain on... Read more
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.
46 2021-04-13 atrial fibrillation, cardiac arrest a fib and cardiac arrest
46 2021-04-13 pulmonary embolism patient developed chest pain, right rib pain and dyspnea 1 day following vaccine
46 2021-04-13 blood clot in lung blood clots in the both lungs
46 2021-04-13 blood clot Patient states that 3 days after she received the Pfizer vaccine she started a mentrual cycle. When... Read more
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.
46 2021-04-15 heart attack Patient presented to Hospital with an anterior wall myocardial infarction 5 days after second Pfizer... Read more
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.
46 2021-04-20 low blood platelet count On 3/17/2021, I began to have a very heavy mentrual period and it was 5 days early (which never happ... Read more
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.
46 2021-04-21 blood clot Superficial blood clot in right leg two large hot swollen spots
46 2021-04-25 vaginal haemorrhage I have been without a menstrual cycle for a minimum of 2 years because of the Depo Provera injection... Read more
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.
46 2021-04-26 atrial fibrillation Patient has rash that started on torso and radiated to entire body lasted about 10 days. Patient de... Read more
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.
46 2021-04-26 deep vein blood clot, blood clot Approximately 2 weeks after the vaccine, inexperienced deep leg pain. 3 days later I went to the ho... Read more
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.
46 2021-04-27 anaphylactic reaction Anaphylactic reaction; a lot of "brain fog"; Diarrhea; Her hip pain has gotten progressively worse; ... Read more
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.
46 2021-04-28 vaginal haemorrhage Lower Abdominal Pain, ongoing Vaginal Bleeding
46 2021-04-28 vaginal haemorrhage Persistent vaginal bleeding since day of vaccine. Symptoms are still occurring.
46 2021-05-07 blood clot Two large hot swollen areas on right leg Went to ER ultrasound detected superficial clot; This is a ... Read more
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.
46 2021-05-09 anaphylactic reaction Eye swollen closed, throat scratchy and swollen. Per ED MD, severe allergic reaction consistent with... Read more
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.
46 2021-05-09 blood clot Prolonged heavy menstrual cycle with excessive blood clot starting on 3/22/21 till present 5/10/21. ... Read more
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!
46 2021-05-11 low platelet count Reported feeling fatigue and contractions early on after the second vaccine dose. Then the next day... Read more
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.
46 2021-05-13 heart attack patient called and said 10 days post she had a heart attack and was hospitalized. no further informa... Read more
patient called and said 10 days post she had a heart attack and was hospitalized. no further information given
46 2021-05-16 blood clot I started having shortness of breath and went to the emergency room. It was determined I had blood ... Read more
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
46 2021-05-18 anaphylactic reaction anaphylactic reaction; I felt like I was dying; heart palpitations; stomach burning; warm sensations... Read more
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.
46 2021-05-19 pneumonia I've had 3 separate issues of cold symptoms in the past month/she has had a cold; I had flu like sym... Read more
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.
46 2021-05-21 blood clot in lung I started having shortness of breath and went to the emergency room. It was determined I had blood ... Read more
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.
46 2021-05-24 transient ischaemic attack 5 days later, pt began to feel tired, 13 days later, she had a TIA with hospitalization for 24 hours... Read more
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.
46 2021-05-26 excessive bleeding I started bleeding and blood clotting and hemorrhaging blood really bad. I have fibroids and anemia.... Read more
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.
46 2021-05-26 vaginal haemorrhage Vaginally bleeding x4 days; diarrhea x 2 mornings; This is a spontaneous report from a contactable c... Read more
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.
46 2021-05-27 transient ischaemic attack Two weeks after receiving my vaccine, I had a mini stroke while driving. I was able to get to my des... Read more
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.
46 2021-06-02 vaginal haemorrhage Post menopausal bleeding starting April 30th and continued through until May 9th and again from May... Read more
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.
46 2021-06-05 vaginal haemorrhage Miscarriage. Had first vaccine dose about 2 weeks after a positive home pregnancy test (on 04/24/202... Read more
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.
46 2021-06-07 atrial fibrillation I had superventricular tachycardia from age 12 to age 28. At 28 years old, I had an ablation to cor... Read more
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.
46 2021-06-13 anaphylactic reaction Anaphylactic Reaction, Epi-Pen, Albuterol given. Transported by Ambulance to ER, given Benadryl, Pe... Read more
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
46 2021-06-14 vaginal haemorrhage post menopausal vaginal bleeding; She had spotting occur a week later on 30Apr2021; This is a sponta... Read more
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.
46 2021-06-19 blood clot 4/19/21 patient states she began menstruating (which was a week past due from her normal expected st... Read more
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.
46 2021-06-20 atrial fibrillation I was diagnosed with Atrial fibrillation after this shot. The first shot was 03-18-2021. A heart mo... Read more
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.
46 2021-07-09 blood clot in lung My sister has developed multiple Blood Clots in both of her lungs. She is now currently hospitalized... Read more
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.
46 2021-07-09 bleeding on surface of brain, brain sinus blood clot dural venous sinus thrombosis involving the mid and posterior aspects of the superior asagittal sinu... Read more
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
46 2021-07-12 blood clot lots of clots; Heavy menstrual-like bleeding; recurring urinary tract infection symptoms; intense lo... Read more
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.
46 2021-07-14 anaphylactic reaction Systemic: Allergic: Anaphylaxis-Mild, Additional Details: PATIENT EXPIRIENCED BRUSHING AND ITCHINESS... Read more
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
46 2021-07-15 blood clot Period lasted longer than 8 days, then restarted and was very heavy and super painful for 5 more day... Read more
Period lasted longer than 8 days, then restarted and was very heavy and super painful for 5 more days, lots of clotts.
46 2021-07-18 anaphylactic reaction Site: Pain at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Diffi... Read more
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
46 2021-07-18 blood clot After having the vaccination and waiting 15 minutes at my PCP's office I left. My husband was drivin... Read more
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.
46 2021-07-21 excessive bleeding After the second dose I had fatigue and arm pain so bad I could not do anything with that arm for li... Read more
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.
46 2021-07-25 vaginal haemorrhage, death, low platelet count death D69.6 - Thrombocytopenia, unspecified N93.9 - Vaginal bleeding JAUNDICE BLOATED SHORTNESS OF B... Read more
death D69.6 - Thrombocytopenia, unspecified N93.9 - Vaginal bleeding JAUNDICE BLOATED SHORTNESS OF BREATH
46 2021-07-26 pneumonia I have been constantly sick since the day of the vaccine, first with pneumonia then consecutive case... Read more
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!!
46 2021-07-28 blood clot One week after my first shot, I got my period and it was very heavy bleeding with clotting for days ... Read more
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.
47 2021-01-11 anaphylactic reaction Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortnes... Read more
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.
47 2021-01-18 vaginal haemorrhage fever of 102 the morning after receiving the vaccine, severe headache, severe eye pain, diarrhea, we... Read more
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.
47 2021-01-26 anaphylactic reaction Systemic: Anaphylaxis-Severe
47 2021-01-26 blood clot Employee states that she received Dose #2 the day after the end of her menstrual cycle and that she ... Read more
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
47 2021-02-02 anaphylactic reaction Systemic: Anaphylaxis-Severe
47 2021-02-06 anaphylactic reaction 2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing w... Read more
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.
47 2021-02-16 death Healthcare was advised that this patient expired approximately two weeks after receiving her initial... Read more
Healthcare was advised that this patient expired approximately two weeks after receiving her initial COVID vaccination
47 2021-03-03 anaphylactic reaction Injection given at 0917 and at 0925 she was coughing and felt someone wrong with her breathing and h... Read more
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.
47 2021-03-03 vaginal haemorrhage Pt reports menstruating during the first Covid vaccine on 1/19/21 and experiencing an increase in va... Read more
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
47 2021-03-03 vaginal haemorrhage pt reports having a heavier than normal vaginal bleeding/menstruation with the first dose on 1/19/21... Read more
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.
47 2021-03-07 pneumonia That same evening I began to be more short of breath and just didn't feel good. I had lethargy and g... Read more
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.
47 2021-03-14 cerebrovascular accident PATIENT UNRESPONSIVE. SPOUSE REPORTING FOR PATIENT, PER SPOUSE, "My wife felt bad after the first sh... Read more
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 2021-03-16 anaphylactic reaction 47-year-old female presented for anaphylactic allergic reaction after getting her first dose of Covi... Read more
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.
47 2021-03-18 deep vein blood clot Woke up with pain in left leg lower calf on February 26 one week after my second vaccine. Had pain ... Read more
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
47 2021-03-20 anaphylactic reaction Prior to the shot, my idiopathic anaphylaxis has been in remission. Since the shot, my throat and to... Read more
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.
47 2021-03-24 anaphylactic reaction itchy face Narrative: Moderate anaphylaxis reaction after administration of dose #1 Pfizer covid-19 ... Read more
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.
47 2021-03-29 anaphylactic reaction Anaphalactic
47 2021-04-11 anaphylactic reaction "1423 History of present illness-patient is a 47-year-old female with a significant past medical his... Read more
"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. "
47 2021-04-11 death There were no noted adverse signs or symptoms at the time of vaccination. Fiance of patient called P... Read more
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
47 2021-04-15 blood clot Started having headache, chills and body aches on 4/1/2021. On 4/2/2021 I had major fatigue. On 4/4/... Read more
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.
47 2021-04-17 transient ischaemic attack while sitting right arm went numb, then couldn't get words out to speak and was confused; was taken... Read more
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;
47 2021-04-18 deep vein blood clot, blood clot, pulmonary embolism Blood Clots; Pulmonary Embolisms; DVT (Deep vein thrombosis); This is a spontaneous report from a co... Read more
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).
47 2021-04-21 vaginal haemorrhage High/Drunk feeling within 1 hour of shot, Not able to sleep at night for first 72 hours (2 hrs 1st ... Read more
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.
47 2021-04-22 grand mal seizure Patient received her second Pfizer vaccine on 4/12/2021. On 4/19/2021 patient had a localized right... Read more
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.
47 2021-04-23 transient ischaemic attack, cerebrovascular accident tia in right eye, on Friday morning on 4/16/ 21, between the hours of 8 am and 9:30 am, I went from ... Read more
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.
47 2021-04-25 anaphylactic reaction Patient had an anaphylactic reaction to the Pfizer Covid19 vaccine. She had chest tightness in the f... Read more
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.
47 2021-04-26 excessive bleeding I had a tattoo done on Sunday night (4/18). I have had many tattoos before this. The first two days ... Read more
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.
47 2021-04-27 death The decedent was found in her bedroom by her daughter. Medical history only includes previous blood ... Read more
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.
47 2021-04-28 death died on 14Apr2021 01:30 pm of a sudden death; first dose of BNT16B2 on 15Mar2021 09:00 am/ second do... Read more
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
47 2021-04-28 deep vein blood clot Pt states that she developed right forearm pain and swelling the day after. She was seen by me on 4/... Read more
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.
47 2021-04-29 blood clot After 2 days of receiving my first COVID vaccine, I started my menstrual cycle. My cycle was very he... Read more
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.
47 2021-05-05 excessive bleeding I felt light headed shortly after leaving or within the 1/2 hour after vaccine. Later that evening i... Read more
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
47 2021-05-08 blood clot Menstrual irregularities. Light spotting for at least one full week (never experienced). Heavy bleed... Read more
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).
47 2021-05-12 low blood platelet count Onset diffuse bruising prior to presentation to emergency department. Platelets = 2,000. Acute IT... Read more
Onset diffuse bruising prior to presentation to emergency department. Platelets = 2,000. Acute ITP diagnosed.
47 2021-05-14 pulmonary embolism multiple bilateral pulmonary embolism; shortness of breath; elevated heart rate; elevated blood pres... Read more
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.
47 2021-05-17 cerebrovascular accident Stroke on the left side of the brain, evolved temporal
47 2021-05-17 death Hospitalized for COVID-19 pneumonia on 4/23, ICU on 5/3, passed on 5/17 of 2021
47 2021-05-18 anaphylactic reaction Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling... Read more
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.
47 2021-05-18 blood clot Site: Pain at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Se... Read more
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
47 2021-05-19 deep vein blood clot Upper extremity DVT, currently anticoagulated with Xarelto
47 2021-05-21 fluid around the heart 2 weeks post second vaccine with pericarditis (classic positional chest pain and pericardial effusio... Read more
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.
47 2021-05-24 grand mal seizure Patient was described as having a "Grand mal" seizure within 15 minutes of vaccination. Patient was... Read more
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.
47 2021-05-25 death After first dose her mental status become slightly altered and she leaned to the left a bit when sta... Read more
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.
47 2021-05-25 deep vein blood clot, pulmonary embolism severe pain when breathing which resulted in bilateral pulmonary embolisms, DVT in right calf, non-o... Read more
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.
47 2021-06-02 blood clot Blurry vision and( flashing light in peripheral vision )right eye the next day after receiving the s... Read more
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 -
47 2021-06-02 vaginal haemorrhage Monday April 5th I started bleeding. I thought it was my normal period. Tuesday I started havin... Read more
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).
47 2021-06-03 bleeding on surface of brain became unresponsive, intubated in the field with CT images revealing a diffuse SAH, IVH, cerebral ed... Read more
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.
47 2021-06-09 blood clot in lung Presented with muscle pain in left shoulder and left side that got progressively worse over a few da... Read more
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.
47 2021-06-11 anaphylactic reaction Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic:... Read more
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.
47 2021-06-16 anaphylactic reaction Suspected anaphylactic reaction managed with epinephrine, solumedrol, Benadryl
47 2021-06-21 deep vein blood clot Deep vein thrombosis left leg, Lovenox f/by Pradexa. On 5/28/21, received pfizer covid vaccine 2nd d... Read more
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
47 2021-06-22 anaphylactic reaction History is provided by the patient. This is a 47 year old female with self reported past medical his... Read more
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.
47 2021-06-22 vaginal haemorrhage Later that afternoon I felt like a ton of bricks hit me. Almost like I was going to faint. When I go... Read more
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.
47 2021-06-28 cerebrovascular accident I had the tired symptoms and fatigue next day. They got worse and i had memory issues, speech proble... Read more
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.
47 2021-06-29 heart attack The patient experienced chest pain/heaviness in addition to interscapular stabbing pain radiating in... Read more
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.
47 2021-07-07 pneumonia I was prepping for a colonoscopy at the hospital, I had ketoacidosis. In the process of being there,... Read more
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.
47 2021-07-12 blood clot I?ve been in menopause since May 2019. On June 4,2021 10 days after my first dose of the Pfizer vacc... Read more
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.
47 2021-07-12 blood clot 6/30/21, 20 minutes after headache and fatigue. More tired that usual over next few days and hard to... Read more
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
47 2021-07-18 blood clot, pulmonary embolism The next day(Friday) after my first Pfizer covid vaccination, in the evening around 7pm I started e... Read more
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.
47 2021-07-19 stroke I63.9 - Cerebral infarction, unspecified N17.9 - Acute kidney failure, unspecified
47 2021-07-21 vaginal haemorrhage 3 weeks after 4/15 I started having vaginal bleeding at first I thought it was my menstrual cycle bu... Read more
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.
47 2021-07-26 blood clot in lung, blood clot Blood clots in right leg and both lungs
47 2021-07-27 anaphylactic reaction anaphylaxis/allergic reaction; Mast Cell Activation Syndrome; Drug Hypersensitivity Syndrome; Intole... Read more
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.
47 2021-07-28 ventricular tachycardia, death, cardio-respiratory arrest Patient received both doses of the Pfizer vaccine on 2/24/21 and 3/17/21. Patient came to the ER on ... Read more
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.
48 2021-01-04 anaphylactic reaction Anaphylaxis, Tachycardia, Lips numbness, tingling, Throat feels full, increased saliva Narrative: em... Read more
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.
48 2021-01-06 anaphylactic reaction anaphylactic reaction; neuropathy in fingers, toes, roof of mouth/lips; This is a spontaneous report... Read more
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.
48 2021-01-13 anaphylactic reaction Anaphylactic reaction with EpiPen administration in vaccination clinic, followed by Rapid Response T... Read more
Anaphylactic reaction with EpiPen administration in vaccination clinic, followed by Rapid Response Team initiation and immediate transport to Emergency Room.
48 2021-01-14 severe muscle breakdown Per patient: I received the 2nd vaccine on 1/6/2021. That night, I developed a headache. By Thursday... Read more
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.
48 2021-01-19 anaphylactic reaction Client received vaccine at end of our clinic day around 4:05 pm. No history of severe allergies, onl... Read more
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.
48 2021-01-19 anaphylactic reaction Site: Itching at Injection Site-Severe, Systemic: Anaphylaxis-Medium, Systemic: Rash (other than inj... Read more
Site: Itching at Injection Site-Severe, Systemic: Anaphylaxis-Medium, Systemic: Rash (other than injection site)-Medium
48 2021-01-23 anaphylactic reaction chest tightness, cough, runny nose, nausea, dizzy, red chest, high pitch voice, difficulty speaking.... Read more
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
48 2021-01-24 sepsis Acute pancreatitis with sepsis; Acute pancreatitis with sepsis; This is a spontaneous report from a ... Read more
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.
48 2021-01-26 heart attack Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest... Read more
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
48 2021-01-27 death Expired in sleep on 1/24/21
48 2021-01-29 anaphylactic reaction After ten minutes my throat began to feel swollen, a feeling of a lump in my throat. After around 2... Read more
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.
48 2021-02-12 severe muscle breakdown Intense soreness/pain in muscles ( arms, under breasts rib area, thighs, lower legs and ankles), bl... Read more
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.
48 2021-02-16 cerebral haemorrhage Hemorrhagic stroke, abnormal platelet count, petechai. Patient had my!triple CTs, MRI and angiogram ... Read more
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
48 2021-02-18 anaphylactic reaction Anaphylaxis
48 2021-02-21 death patient was not vaccinated at hospital. Caregiver reports that patient was vaccinated with second d... Read more
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.
48 2021-03-10 anaphylactic shock anaphylactic shock; BP 209/109 within 15 minutes of the shot/elevated BP; major headache; This is a ... Read more
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.
48 2021-03-17 deep vein blood clot I received the first does of the Pfizer vaccine and within 24 hours had started developing a superfi... Read more
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.
48 2021-03-19 deep vein blood clot Acute deep vein thrombosis of femoral vein of left lower extremity.
48 2021-03-22 pneumonia Intense pain in arm followed by joint pain 5 days later I have fever, loss of taste and smell, diarr... Read more
Intense pain in arm followed by joint pain 5 days later I have fever, loss of taste and smell, diarrhea, chills, disorientation, difficulty breathing
48 2021-03-24 anaphylactic reaction anaphylaxis; pounding of heart; tightness of chest; Itching; coughing; hives; swelling of throat and... Read more
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.
48 2021-03-25 vaginal haemorrhage Within a short time after receiving my COVID vaccination, I experienced a burst of energy, pretty se... Read more
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.)
48 2021-03-31 anaphylactic reaction Patient had an anaphylactic reaction and had to use her Epipen
48 2021-04-03 blood clot Arm pain on first day Tendons stiffness on one arm and both wrists on second night 4th day - Early m... Read more
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
48 2021-04-07 cerebrovascular accident Stroke; This is a spontaneous report from a contactable pharmacist. A 48-year-old female patient rec... Read more
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.
48 2021-04-07 cerebrovascular accident 03/24/2021 11:00 AM - PM sore throat - 03/25/2021 around 3:40PM had massive stroke while alone. 03/2... Read more
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.
48 2021-04-08 blood clot swelling, redness, and warmth in shoulder of right arm starting about 7-8pm on 04/08, patient went t... Read more
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.
48 2021-04-12 transient ischaemic attack mini stroke; having vision issues; having vision issues, she could not focus and started seeing flas... Read more
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.
48 2021-04-15 anaphylactic shock Started to have body aches, head aches and neck pain from next day morning and keep on progressing t... Read more
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 .
48 2021-04-15 deep vein blood clot DVT Left calf. Started as pain in the left calf on morning after vaccination. Seen by PCP 1 week lat... Read more
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.
48 2021-04-16 death Patient reported severe headache on 2/12/21 at approximately 3:30 pm followed by vertigo, nausea, vo... Read more
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.
48 2021-04-16 deep vein blood clot Accute deep vein thrombosis of popliteal vein of right lower extremity.
48 2021-04-17 pneumonia felt symptoms similar to pneumonia; This is a spontaneous report received from a contactable consume... Read more
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
48 2021-04-17 vaginal haemorrhage However, the day after my injection I had light bleeding for 5 days which required light tampons to ... Read more
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.
48 2021-04-18 blood clot, deep vein blood clot A week after receiving the shot, I started experiencing severe pain in my left calf. On Friday, Apri... Read more
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.).
48 2021-04-19 deep vein blood clot Blood clot in the Right arm, s/s started 48 hours after first shot in the series.
48 2021-04-20 excessive bleeding became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin... Read more
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.
48 2021-04-21 transient ischaemic attack I felt numbness/tingling in right hand and right foot upon wakening (5:00 AM) on 4/19/2021. I furth... Read more
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.
48 2021-04-22 deep vein blood clot Pt. came in for her 2nd shot on 4/22. She informed staff she received the 1st vaccine on 3/26 and de... Read more
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.
48 2021-04-24 anaphylactic shock Throat got tight; cholesterol is off and thyroid; thyroid function test: off; minor anaphylactic sho... Read more
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.
48 2021-04-26 anaphylactic reaction Anaphylaxis. Patient with a h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling,... Read more
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.
48 2021-04-26 transient ischaemic attack I felt numbness on right side of face; TIA (mini stroke); I felt numbness/tingling in right hand and... Read more
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.
48 2021-04-28 deep vein blood clot Developed a blood clot in peroneal vein of left leg.; This is a spontaneous report from a contactabl... Read more
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.
48 2021-05-02 vaginal haemorrhage Extremely heavy period. Haven?t had one in 18 months due to pregnancy and breastfeeding. This is ... Read more
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.
48 2021-05-04 blood clot Pfizer BioNTech-Covid-19 vaccine EUA--4/10/2021 started having abdominal pain radiating to back, lef... Read more
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.
48 2021-05-04 blood clot took 2 generic Whole Foods 365 brand Acetaminophen Expiration Date: Jun2020 in Apr2021; ear crystals... Read more
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.
48 2021-05-07 pulmonary embolism high heart rate; high blood pressure; shortness of breath; bilateral pulmonary emboli; This is a spo... Read more
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.
48 2021-05-09 anaphylactic reaction Severe anaphylaxis- Red on face and arm (hives/itching), severe shortness of breath, and severe swel... Read more
Severe anaphylaxis- Red on face and arm (hives/itching), severe shortness of breath, and severe swelling of face and under the arms.
48 2021-05-10 blood clot swelling behind the knees and swelling of the veins; it had to do with blood clot warnings / it was ... Read more
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.
48 2021-05-11 excessive bleeding I am a 48 year old Female been in Menopause for 3years ( no cycle for 24plus months), 4 days after r... Read more
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
48 2021-05-14 blood clot Got my second Pfizer Covid shot Friday, by Monday I had a huge blood clot in my neck and also a huge... Read more
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.
48 2021-05-14 vaginal haemorrhage felling sick; fever; malaise; extreme nausea; throbbing of her arms and legs; dizziness; she started... Read more
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.
48 2021-05-17 heart attack headache; fatigue; dyspnea; chest pain; RV infarction; a large amount of clot in the RCA; This is a ... Read more
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.
48 2021-05-18 fluid around the heart Immediately after first dose of vaccine patient developed worsening fatigue, exertional dyspnea, fev... Read more
Immediately after first dose of vaccine patient developed worsening fatigue, exertional dyspnea, fever, cough, body aches. These symptoms persistent wit