chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was severly dizziness and took it upon himself to lay down on the floor.  He was also experiencing nausea, sweating on his head, and fast heartbeat which was conveyed to the EMT.  He also requested an ambulance.
Immediately after 1st dose began whole body myalgias, headaches and joint stiffness. Worsened after 2nd dose- continues to this day, 12/10/21, Almost cannot work due to joint/muscle inflammation
Feeling a lot of PVCs. Went to dr office for ekg who sent me To er for left bundle branch block.  Tests done which showed mild cardiomyopathy with EF 41.5.  Mri states could be from chemo years ago or could have been myocarditis.  Worried now do I get a booster if one is offered or is that going to make ef worse etc
Foster parents brought child in for physical, immunizations. H1N1 requested, not on immunization record foster parent had, did not see on back of immunization sheet in chart. Also, KINRIX used in error.
2 months ago the arm they put the vaccine in started aching when, patient sleep on it and it doesn't hurt to touch it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm, administration date Feb2021 (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 (dose 1, single), administration date: Feb2021, for COVID-19 immunisation, reaction(s): "no reaction at all". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "2 months ago the arm they put the vaccine in started aching when, patient sleep on it and it doesn't hurt to touch it".  Additional information: Patient stated that received the COVID vaccine about 9 months ago and then 2 months ago his arm started hurting and his doctor does not know what is causing that. Patient said he does not believe it was related to the vaccine and did not think it was an adverse reaction. It typically happened after getting the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Starting after vaccine had redness, itching around injection site. It was hot to the touch. About two inches in diameter. Contacted pcp who advised hydrocortisone for itch and monitoring. Symptoms seemed to drastically improve and were not noticeable for a few days. Starting 1/17/21 the injection site began itching again and felt very hot and was noticeably red. Overnight the size of the redness increased to about 4 inches in diameter and became increasingly uncomfortable. I reached out to my PCP and sent pictures. He prescribed keflex for presumed cellulitis.
I?ve noticed quite pronounced ringing in my ears over the past few months. I went to my doctor?s office to see if something could be done. She asked if I had had a Covid booster within the past six months, which I told her I had. She said others had reported similar ringing following a Covid booster.
Migraine after 10 min, couldn't see. Abdominal cramps, then felt crappy, lethargic.
pt recv vax 30JUL97 & parents states approx 1hr later, pt got pale, lethargic, very relaxed;episode lasted 4-5min;
Left arm felt sore and has gotten worse. It is now painful to move and my range of motion is limited because of pain.
Information has been received from an investigator regarding a patient enrolled in a trial. The subject received Infanrix as a control for pneumococcal 7-valent conjugate vaccine and subsequently developed a grade 3 injection site reaction characterized by erythema and induration. Grade 3 reactions were considered serious per protocal. The investigator felt the erythema and induration were definately related to Infanrix administration.
1MAY91 8PM lightheaded, nauseated, rt jaw hurting, MN all joints stiff, achey, lt jaw hurt, swollen rt lymph node in neck; 2MAY91 t99;
Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22-Jul-2021 and 10-Aug-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22-Jul-2021 and 10-Aug-2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22-Jul-2021 and 10-Aug-2021). On 11-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered as second dose after temperature excursions on 22-Jul-2021 and 10-Aug-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  It was reported that issue was on 7/22/21 involved 2 vials of lot 17C21A.On that date, upon review of his  notes, the unit alarmed at -14.9C and was above for 15 minutes when vials were removed to secondary unit for 24 hours and maintained at -17C to -22C. This issue was actually due to a freezer pack leak that froze the element in the primary unit. The vials were kept in the secondary unit while the primary unit defrosted and was reset. This was the date of the incident where a thawed freezer pack was placed against the sensor. It was reported that manual thermometer on that freezer unit showed -19C, so no action was taken.The two vials of lot 17C21A remained in the primary freezer unit and the digital reader was reset.  Had the secondary freezer unit on site. With previous excursion, primary freezer alarmed at -14.6C and vials were immediately moved to secondary unit (move took less than 30 seconds) and maintained at -18C. With this excursion, the primary freezer unit was left open and alarmed at -14.7C. The same procedure was followed and our one remaining vial was immediately moved to the secondary freezer and maintained at -18C.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow-up received on 30-September-2021 contains ADR form
No adverse events or treatments reported. Vaccination mistakenly given 2 weeks (14 days) after the first dose rather than the standard 21 days. Patient's vaccine card was written incorrectly for the return date of 14 days and this mistake was not caught before administering the 2nd dose.
Pt recvd vax on 13Sep92 or 14SEP92 & on 10OCT92 devel swelling of lt axillary lymph glands; No further details were provided;
Patient experienced low grade fever over several days, severe muscle pain in left arm, bruising, redness, swelling and warmth to touch on second day
Information has been received from a physician concerning her son who was vaccinated with VARIVAX vaccine (Oka/Merck) (lot # not provided). Subsequently the patient experienced a mild case of breakthrough chickenpox on the back of his neck and back. Subsequently, the patient recovered from mild breakthrough chickenpox. The patient sought medical attention. Additional information has been requested
Info has been received from a consumer concerning an approx. 7 month old male with Down's Syndrome who in approx. November, 2002, at 2 months of age, was vaccinated with a 1st, 2nd and 3rd dose of Hep-B. The pt "had bad reactions to his Hep-B vaccinations." Unspecified medical attention was sought. Subsequently, on 10/14/02, the pt was vaccinated with a dose of MMRII and a dose of Varivax and experienced adverse events (WAES 0211USA00174). Follow-up info from the physician stated that "the child received Hep-B alone not (Hib (+) Hep-B at the visit where a possible reaction occurred". It was also noted that the immunization associated with the reaction was given on 4/26/02. Additional info is not expected.
Pt presented p/immun w/shock was subsequently dx'd as having "hemorrhagic -encephalopathy synd;
the DTAP/IPV portion of the Pentacel was administered and later that day had the patient administered with the actual ActHIB vaccine (not the ActHIB portion that comes with the Pentacel); Initial information received on 12-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demography who she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that the DTAP/IPV portion of the Pentacel was administered and later that day had the patient administered with the actual ActHib vaccine (not the ActHib portion that comes with the Pentacel).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate reconstitution technique.  It was not reported whether the patient experienced any adverse events following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Heart palpitation of 122 hps that lasted 12 hours; Fatigue; short of breath; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 46 years old, in left arm on 14May2021 11:30 at single dose for COVID-19 immunisation. The patient medical history was none. The patient was not pregnant. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks and any other medications within 2 weeks prior to vaccination. The patient previously took hydrocodone bitartrate and acetaminophen (VICODIN) and eritromicina (reported as erithromicine) and experienced allergies. The patient previously received the first dose of BNT162B2 (lot number: unknown), at the age of 46 years old, in left arm on 23Apr2021 11:30 at single dose for COVID-19 immunisation. The patient experienced heart palpitation of 122 hps that lasted 12 hours, fatigue and short of breath on 15May2021 02:00. The patient had not been tested for COVID-19 since the vaccination. No treatment received. The outcome of events was recovered.  Information on the lot/batch number has been requested.
Strange vivid dreams.  Four nights in a row now after the shot.  Hopefully they will stop soon.
On 6/25/22 @ 0945 pt received dose 1 in his L arm. At 0134 on 6/26/22 he woke with a bloody nose.   On 7/23/22 @ 0915 pt received dose 2 in his L arm. At 2353 he woke with a bloody nose.
The first attempt at Intradermal Vaccine administration did not yield a wheal. Another vaccinator reattempted the ID administration, and the attempt was successful.
This spontaneous report as received from a medical assistant refers to a 4 month old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 03-AUG-2017 at 14:25 hrs, the patient was vaccinated with incorrectly stored dose of ROTATEQ (strength, dose and expiration date were not reported) lot # M046006 dose 2 for prophylaxis (onset date was reported as 02-AUG-2017 08:45 hrs). Other suspect therapies included PENTACEL (strength, dose and expiration date were not reported), lot# C5295AA, dose 2, in left thigh for prophylaxis and PREVNAR (strength, dose and expiration date were not reported), lot# 531255, dose 2, in left thigh for prophylaxis. No adverse event or reaction was reported by the patient. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1708USA001493.
There was no adverse effect per the patient but the wrong vaccine was given to the patient. He was to receive a hepatitis B vaccine
Diarrhea within on ehour of vaccine. Then devel;oped body aches and fatigue that have been persisting.
Numbness in his limbs; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious), outcome "recovered with sequelae", described as "Numbness in his limbs". The event "numbness in his limbs" was evaluated at the physician office visit. Therapeutic measures were taken as a result of hypoaesthesia. Additional information: Reporter stated that the patient had received his first dose of the Pfizer vaccine and call back three days later and reported numbness in his limbs so, he went to his primary care and received gabapentin but still having some lasting effect. So, his primary care called and wanted some guidance on when he should receive his second dose. The lot number of COVID-19 Vaccine was not received as the reporter hung up the call abruptly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown) via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. on 19Mar2021, the patient experienced left kneecap went numb/started to come back, but just a little bit around the edge of the kneecap (hypoesthesia); on an unspecified date, the patient experienced knee pain/started getting pain, nothing severe/having pain even in bed when he repositioned/pain in the knee which made it to where it hurt to walk/walking I had pain and its making me limp this morning, knee pain/started getting pain, nothing severe/having pain even in bed when he repositioned/pain in the knee which made it to where it hurt to walk/walking I had pain and its making me limp this morning (gait disturbance), back pain, starting in the lower back and it kept getting worse, up my back, pain the size of a dime, like where your kidney is, lasting about 30 seconds, then it would wrap around to my appendix, bothered me all day (back pain), soreness to their arm where the injection was given. The clinical outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning an approximately 60 year old female who was vaccinated with a dose of PNEUMOVAX 23. Later in the vaccination evening, the patient had pain, swelling, redness, hot to touch and cellulites that went from below the injection site down the arm. The physician reported that the experience got progressively worse over the next couple of days, and a hot pad and anti inflammatory medication was provided. The physician reported that the patient was recovered on therapy. The physician reported that he gave this same vial to two other patients who had a similar experience (reported in 0902USA01697 and 0902USA01706). The patient saw physician for medical attention. Follow-up information was received from a certified medical assistant concerning a 66 year old female with hypertension (HTN), hypothyroidism, hypercholesterolaemia who on 05-FEB-2009, at 10:30, was vaccinated with a dose of PNEUMOVAX 23 (lot #: 661528/0867X) into her right deltoid. On 05-FEB-2009, at 17:00, the patient developed pain swelling redness at the injection site within 4-5 hours post injection. Area of swelling was from right shoulder to right wrist. The patient also experienced difficulty moving arm with 24 hours of injection and worsening cellulitis to 48 hours post injection. BENADRYL and ice packs provided little relief or change. Swelling and pain lasted for 72 hours post injection. Issues/reaction completely resolved within 96-100 hours post injection without further intervention. No further information is available.
PATIENT WAS GIVEN A DOSE THAT WAS PAST OVER EXCURSION PERIOD OF TIME THAT VACCINE IS VIABLE IN PERIOD OF 12 HOURS AFTER 1ST PUNCTURED. THE VIAL THAT THE DOSE WITHDRAWN WAS 1ST PUNCTURED AT 6/16/2021 09:30 AM. VACCINED IS  26 HOURS OF EXCURSION TABLE WHEN VACCINE WAS GIVEN.
Approximately 30 min after Hep A/FLUMIST administered patient broke out with a rash - itchy on trunk 25 mg BENADRYL given at 11:50AM.
SORENESS; HEADACHE; NAUSEA/QUEASY; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 15:10 in the left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAR-2021, the subject experienced nausea/queasy. On 16-MAR-2021, the subject experienced soreness. On 16-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 16-MAR-2021, was recovering from soreness, and had not recovered from nausea/queasy. This report was non-serious.
Tingling around the mouth; Swollen around the injection site; A spontaneous report was received from a consumer concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tingling around the mouth, swollen around the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 014ML0A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Mar 2021, the patient experienced the event(s) tingling around the mouth, swollen around the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tingling around the mouth, swollen around the injection site was unknown.
no adverse effects; administered one dose of expired VAQTA; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 02-OCT-2019, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 1 dose, lot # R027987, with expiration date on 09-AUG-2019 (dosage schedule, route and anatomical location were not reported), for prophylaxis (expired product administered).
Rash on whole body. Red, fine raised itchy rash on face, chest, back, arms Small amount in groin and on legs Face sl swollen
Information has been received from a registered nurse concerning a 65 year old male with no reported medical history who on approximately 14-NOV-2007 was vaccinated with pneumococcal 23v polysaccharide vaccine (Lot #655291/0985F). On 14-NOV-2007 the patient developed an injection site reaction which included pain, swelling and redness. This was the patient's second dose of pneumococcal 23v polysaccharide vaccine. The patient sought medical attention with an office visit and recovered on an unspecified date. This is one of several reports received from the same source. Additional information has been requested.
TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included ulcerative colitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ultrasafe passive for ulcerative colitis, ultrasafe passive accessory for ulcerative colitis, and ustekinumab for ulcerative colitis. On MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness was not reported. This report was non-serious.
HEART WARMING HYPERTROPHIC CARDIOMYOPATHY; PARTIAL LOSS OF SIGHT; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age. sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced recurrent migraines (dose number in series 1) when treated with BNT162 for prophylactic vaccination (Dose number in series 1). The outcome for recurrent migraines was not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that "PII You're gonna love that new one by Johnson & Johnson #3. Feeling even better when you mix-up! It embrace heart warming hypertrophic cardiomyopathy, partial loss of sight but sadly no recurrent migraines like Pfizer #6". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart warming hypertrophic cardiomyopathy and partial loss of sight was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20211238271-covid-19 vaccine ad26.cov2.s -Heart warming hypertrophic cardiomyopathy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Fatigue, muscle aches, chills, sweats, no appetite - onset same day. Red rash on arm. Symptoms peaked at day 4, followed up day 7, feeling a little better.