chrisvoncsefalvay/vaers-outcomes huggingface dataset:
atrial fibrillation; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not reported.   The patient said that her sister received the Moderna Covid-19 bivalent vaccine and developed an atrial Fibrillation immediately after receiving the Moderna Covid-19 vaccine. It was not known what dose of vaccine that the patient received.  Treatment medication not reported.  Company comment:  This is a spontaneous case concerning a female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Atrial fibrillation. The event occurred immediately after the administration of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine, dose number is unknown.  No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) Vaccine is not affected by this report.
Round itchy red patch; This is a spontaneous report from a contactable consumer. A 84-year-old male Patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date was Unknown) via unspecified route of administration on27Jan2021, 03:00 PM (at the age of 84-year-old) as a single dose for COVID-19 immunization. The patient past medical history included diabetes mellitus. The concomitant medication was not reported. There was no known allergies. Patient did not have COVID-19 prior and post to the medication. On 04Feb2021, the patient experienced Round itchy red patch. The outcome for the event recovered on an unspecified date in 2021.  Information on the Lot/batch number has been requested.
Eczema, began two days after vaccination on 9/22/2023, spread and covering entire body (elbows, knees, buttocks, thighs, calves, hands, forearms, patches on back, spots on feet, spots on upper and inner arms) as of 10/18/2023 ongoing and being treated by topical steroid as well as over-the-counter remedies
Broke out with hives in the middle of the night 8 days after the injection. Thigh area. Took Benadryl and it was gone in a few hours. Happened second and third night as well....but not as many hives each night
Very tired and sweaty approximately 1:30 at gym - left early - lay down approximately 2 hours - approximately 7:00pm walking in restaurant got very dizzy - thought I would fall - husband grabbed me (never happened before - husband also had shot - he was fine). Felt better next day.
Apnea noted at home by mother 3/18 afternoon brought to ER, apnea in ER leading to acute resp failure requiring intubation and transfer ICU - here he required mech ventilation, central line placement and blood transfusion. Treated empirically with meningitic antibiotic dosing. Requires vent support 4 days, now extubated and back to room air. Continuing to work on feeding and monitoring for apnea. No further apnea observed.
The pt experienced a 5 x 4 cm induration at the site of injection with erythema and warmth.
Patient developed dry rough area on injection site which developed into a dime-sized wound a week later. To date, wound had not healed and patient was advised to see MD.
First shot 3/6/21 totally fine after. Second shot, 3/27/21 started feeling fullness in my left ear two days later. Felt I had an ear infection. On 4/1/21 I started getting loud Tinnitus in both ears. It is still here today. It is awful.
eyesight problems. Her vision went blurry; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (took both doses of the Pfizer vaccine about 3-4 months ago), for Covid-19 immunisation. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "eyesight problems. Her vision went blurry".  Additional information: Reporter provided In a qualitative interview, the respondent reported that they knew someone (sister of a friend) who took both doses of the Pfizer vaccine about 3-4 months ago and a couple of weeks after the second dose, she developed eyesight problems. Her vision went blurry and she went to her doctor and had still currently experiencing problems with her eyesight.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. Since January 2016 the patient were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L038018 with expired date 13-SEP-2017, digital data logger, dose and route were unknown). No concomitant therapy was reported. The improperly stored doses of RECOMBIVAX HB (lot # L038018 with expired date 13-SEP-2017, digital data logger, dose and route were unknown). No concomitant therapy was reported. The improperly stored vaccines were stored under 53.8 F for 4 hours and 48 minutes. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
patient was fine when walking out of vaccine room but walked half way down an isle and passed out. Patient stated he felt warm prior to passing out.  He was warm and clammy. He hit his head but refused medical treatment. No blood. Advise him to monitor for concussion.
Sore Throat, Cough, Wheezing, Temp of 102, Sneezing, Soreness, Lack of energy. Treatment: Ibuprophen, Lots of liquide, Bed rest
Positive chicken pox at age 4 diagnosed by Peds- body rash (small red papules on trunk / back).
My heart began racing while I was at the doctor once.  I was sent to the heart doctor and they didn't find anything.  I got my second vaccine.  I got my booster.  The kids were sleeping and I was in bed and I couldn't breathe.  I called the ambulance.  My heart was racing.  They thought it was lungs and I felt pressure on my chest.  I went to the ER.  My enzymes from my heart were through the roof.  I had an EKG.  They also looked for blockage.  My heart lines were swollen and my heart was only pumping 20%.  They had started me on blood pressure medicine but that wasn't helping.  The cardiologist stated I have a cardio vascular disease.
Approximately 10 minutes after 1st dose of Pfizer vaccination. Pt. was fanning himself, appeared diaphoretic with mask down. He flagged down nurse and reported feeling hot/lightheaded. NP asked for BP machine, instructed patient to take slow deep breaths. Pt. reported he felt like he may lose consciousness. His eyes rolled and he became white/pale and appeared to stop breathing. Code assist called; didn't respond to sternal rub, but raspy breathing, weak/rapid pulse palpated; immediately transferred to the ground level without falling, 2 person assist. 9-1-1 called, BP machine didn't immediately work. As soon as his head was low, his face became bright red and he regained consciousness. He was disoriented briefly but then able to answer questions/oriented. BP elevated, HR 80s. BS 257. No s/s anaphylaxis. Hx of syncope r/t blood draw. Wife present and report hx of DM, HTN, Palpitations. He denied CP/SOB or palpitations. He had eaten and took regular medicine the morning. Paramedic arrived and patient was transported to the nearest ER. Pt. was later discharged.
This infant ran a fever of 100.2 axillary, the evening after her immunizations and had a runny nose. 05/01, @ 16:45, temp 100.8 axillary.
Received covid vaccine and has been sick ever since; Difficulty breathing; Cough; Sneezing; This is a spontaneous report from a contactable Other HCP (Nurse) communicated to Pfizer-sponsored program for a female patient.  A 63-year-old female patient started to receive tofacitinib citrate (XELJANZ XR, 11mg prolonged release tablet) orally from an unspecified date and ongoing at 11 mg once daily for rheumatoid arthritis; received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 01Apr2021, as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); Oxycodone hydrochloride, paracetamol (OXYCODONE AND ACETAMINOPHEN); Lorazepam; Homatropine methylbromide, hydrocodone bitartrate (HYDROCODONE BIT. AND HOMATROPINE METH.); Methotrexate sodium; Ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS); Atorvastatin (LIPITOR [ATORVASTATIN]); Amlodipine besilate, benazepril hydrochloride (AMLODIPINE BENAZEPRIL), all taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine sulphate, gabapentin and lisinopril and experienced allergy to all. The patient reported that she received the COVID vaccine on 01Apr2021 and has been sick ever since. The patient stated she was still taking tofacitinib citrate. The patient stated symptoms were difficulty breathing, cough and sneezing. It was unknown if the patient was pregnant at time of event. The patient stated she was tested for COVID and was negative. The prescribing medical doctor (MD) was not aware. Tofacitinib citrate start date unknown, first withheld ship 21Jun2016. The action taken in response to the events for tofacitinib citrate was dose not changed. The outcome of the events was not resolved.  No follow up attempts are needed. No further information is expected.  Follow-up (03May2021): This is a follow-up report combining information from duplicate reports 2021498007 and 2021497979. The current and all subsequent information will be reported under manufacturer report number 2021497979. Added the details of Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain at the side of injection, redness at the side of injection 2 days after, migraine, swollen lymph nodes of the left armpit and left side of the throat (4 days), low grade fever
20-25 mins following: flushed ski on face and neck and fast heartbeat 35 mins following: dizziness, weakness & heaviness in arm 1 hour following: fatigue and tiredness 1 day: sore, red arm - swollen, hot - relieved in a few days 10 days following - injection arm redness, swollen, hot, extreme itchiness; swollen lymph nodes in same arm; joint aches
Nausea and vomiting as well as cramping that lead to being unable to eat for a week. After a week passed, was admitted to hospital for dehydration and to make sure GI problems were nothing more serious
On 7/13/2022 I started feeling like a headache, a little bit of congestion, that got progressively worse. I was feeling feverish. On the 7/14/22 it got worse. On 7/14/2022 I tested positive for COVID-19. On 7/15, I was  very tired, and I had a lot of sinus pressure in my head about 7/18 or 7/19 I started developing a sore throat, the pain was significant. I had a visit with my doctor on 7/20/22 and was prescribed a steroid, Prednisone.  it relieved the sore throat. and the other symptoms started to subside. Once that started to clear up, I had a dry cough that went through the 30th of July.  I was tired the week of the July 25. On 8/3 I started not to feel too much pain. but I felt like I had to clear my throat. I also had a little bit of brain fog on the 1st week of August. kind of like a daze. I started feeling like myself by September 2022.
14APR arm swelled up, 13APR nite fever 103.2 APAP given; 15APR 1AM started seizure; 16APR seen by MD couldn't determine shot as cause of sz; no pertussis next vax;
Day 7 -- still have EXTREME fatigue, nausea and brain fog Day 6 - fatigue, nausea and brain fog Day 5 - fatigue, nausea and brain fog Day 4 - Above + joint pain Day 3 - Above + fever of 101 (fever was higher on day 3 than day 2) Day 2 - Above + fever of 100 Day 1 - vaccine received
This case was reported by a consumer (subject) and described the occurrence of adverse event in a female subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of TWINRIX (unknown details). At an unspecified time after vaccination with TWINRIX, the subject experienced adverse event. The subject did not provide any details of the adverse event at the time of reporting. Attempts were unsuccessful to contact reporter. At the time of reporting the outcome of the event was unspecified.
About 12 hours after the shot I began feeling ill with flu-like symptoms, which is what happened with the first Moderna shot a month earlier. A few hours later, my entire body was throbbing with pain, I was in a cold sweat, my head was aching(it felt like an intense withdrawal) and I was incredibly weak. I stayed totally bedridden for 20 hours, forcing myself to sip water whenever I could muster the strength to sit up. My entire body was red, as though I had a light sunburn. The pain in my body and head was so overwhelming for a short period I considered calling an ambulance, but ultimately rode it out. Most of the pain, redness, and weakness have subsided over a day later, and I am about ninety-five percent back to normal with a very mild head ache.
my symptoms began with severe headache, then body aches followed within just a few minutes,  extreme fatigue and fever that ran from 100.9 down to 99 degrees, loss of appetite. Symptoms lasted for almost 48 hours.
Swollen upper lip; This is a spontaneous report from a contactable consumer (patient). This 58-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administered in right arm as a single dose on 29Jan2021 02:00 PM (lot number: EL3247; age at vaccination 58 years old) and then the second dose administered in right arm as a single dose on 19Feb2021 12.00 PM (lot number: EL3247; age at vaccination 58 years old) for COVID-19 immunization. The most recent COVID-19 vaccine was administered at workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 before vaccination and not tested for it since.Patient received initial dose on 29Jan2021 02:00 PM. He reported a swollen upper lip four days after the initial dose. Patient received second dose on 19Feb2021 at 12:00 PM. Patient stated "tonight" he got a swollen upper lip about 30 hours after the vaccine. Start date was provided as 20Feb2021 at 07:00 PM. No treatment was given. The patient assessed the event as not serious and there was no hospitalization. The clinical outcome of swollen upper lip was unknown.
father & stepmom states pt devel welts all over body (systemic rxn) by 4PM on the afternoon inj given;past records indicated a measles vax given in 1983 & father states had no rxn from inj;pt wasn't taken to MD;
At 4 hours post injection my right upper arm swelled to double its size, at 6 hours it was very hot and painful and at 8 hours my lips swelled and my ulnar nerve was compressed by the edema and the 4th and 5th digits on the right hand tingled. I also was slightly short of breathe and had some wheezing.
During the vaccination, I felt immediate pain and paresthesias. The LPN administering the shot stated, "that felt like it hurt". The pain initially subsided, but 2-3 hours later I began experiencing severe right shoulder pain. I also had the inability to fully abduct my and had limited range of motion.  I went back to the employee health clinic and was sent to the occupational health clinic. Once there, I saw, ARNP. She examined my arm. She gave me a shot of Toradol for the pain and prescribed a Medrol dose pack. A follow-up appointment was scheduled for 12/23/19. I have continued to have severe pain and intermitted tingling in my hand, as well as limited range of motion.
c/o pain & swelling to rt upper arm extending to scapula area w/low grade fever lasting approx 3 days;indurated area rt upper arm w/pain extending back to rt scapula;good ROM of shoulder;no redness or heat @ present;rxn to Td;
Patient reported a small 1-2 inch rash on hip and interior of legs. Rash was itchy and began to subside after 1-2 weeks, patient stated.
Vaccine received at Publix pharmacy in Tiger Point. Patient developed right arm soreness, numbness in right side of her neck, mid back, hip, down her right anteriolateral leg. She also developed shaking that got better with acupuncture 8/3/2021. Also complained of burning in her bladder one week later. Now, she still has left sided subjective facial numbness (neuro exam normal), that occasional shoots down either leg.
Janssen covid-19 vaccine EUA  Aside from injection site pain, about 12 hours after receiving the shot, at 12pm Tuesday, I had a headache, muscle aches, and chills with a temperature of 99 degrees. It subsided with Tylenol but returned as it wore off. On Wednesday morning my temperature was 100 degrees.
This spontaneous report was received from a physician concerning a patient of unknown age and gender. On 16-APR-2008, the patient was vaccinated with dose 1 of GARDASIL (lot number expiry date and dose unspecified), intramuscularly. On 31-JUL-2008, the patient was vaccinated with dose 2 of GARDASIL (lot number expiry date and dose unspecified), intramuscularly. On 28-MAR-2013 (reported as today), the patient would be administered with dose 3 of GARDASIL (lot number and expiry date unspecified). No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
On the 8th, I began having stomach abdominal pain; 10th it progressed to a fever. I went to emergency dept, CT scan, confirmed diverticulitis, prescribed antibiotics and a liquid diet for at least a week. After one day on the med, fever was gone and after four or five days, I began to introduce more solid foods. I have had one flare up around the end of August. I just adjusted my diet until the symptoms went away. Doctor phone consultation one week after.
p/recv vax pt c/o weakness & light headedness; pt knees gave out;no loss of consciousness; fully recovered within 20 minutes;
Tinnitus started in June. I reached out to my primary care physician in July, who recommended I see an ENT. After several visits and diagnostics with the ENT, they determined the Tinnitus was not a tumor. They suggested that it might be TMJ and to see my dentist about a nightguard. My dentist said there's no sign of TMJ, but suggested a nightguard would be a good idea anyway.  I read online reports that tinnitus might be associated with the COVID vaccine, so reporting. Still persists in November.
positive; positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), on 04Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. There were no Known allergies. There were no other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant) with onset 14May2022, outcome "unknown", COVID-19 (medically significant) with onset 14May2022, outcome "not recovered" and all described as "positive". Patient stated, Initial Covid symptoms were mild and after 5 days I felt good and tested negative. 4 days later I woke up congested so tested again and was positive. The symptoms have been much more severe with with congestion, headache, and cough that was much worse. One night the congestion and headache were bad enough I could not sleep. After 4 days of having Covid a second time I am better but slowly recovering and still testing Positive. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive; (unspecified date) positive, notes: After 4 days of having Covid a second time I am better but slowly recovering and still testing Positive; (11May2022) negative, notes: after 5 days I felt good and tested negative; (15May2022) positive, notes: 4 days later I woke up congested so tested again and was positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details: product: COVID 19 Treatment, brand: paxlovid, treatment start date: 06May2022, treatment stop date: 11May2022, lot number: FX8133.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The thing that prompted me to go to the doctor was that Monday morning, I was unable to lift my arm. I had fever and chills Saturday night and my arm started hurting Saturday night and was quite painful on Sunday and by Monday the pain was radiating to my under arm. I called the clinic on Monday and talked to triage nurse. She said they were seeing this with patients who had the booster. She scheduled me an appt for Tuesday in case it wasn't better. I went in to make sure everything was okay. She said I had lymphadenopathy in that arm where the shot was. It was probably related to the vaccine, she said. She gave me some gentle exercises to do so that I would move my shoulder. I opted to not take any prescription medicine. She had me take 800 mg of Ibuprofen every 8 hours. She asked me to get back in touch with her by Thursday. I was still having pain on Thursday, so she decided that I stay on the Advil for another day. It is still a little sore now, but I have full movement back now so I'm not nearly as worried about it. Note: I do not know for sure what brand of flu vaccine that I received that day - it was the flu vaccine that everyone for the whole company received.
Soreness; had blood pressure; This case was reported by a consumer and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) (batch number ZM3D2, expiry date 3rd April 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and blood pressure abnormal. On an unknown date, the outcome of the pain and blood pressure abnormal were unknown.   It was unknown if the reporter considered the pain and blood pressure abnormal to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The Patient received Shingrix and had blood pressure and soreness. The Patient had blood pressure was coded blood pressure abnormal due to insufficient information. The reporter did not consent to follow-up.