chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a Moderna vaccine under 18 years old. No adverse effects occurred. Only had a sore arm for 2-3 days. Parent states she will notify the HCP.
Pt devel nausea, malaise & fever 3 days p/vax w/Hep B;
severe diarrhea and it was the worst he had ever experienced; feverish; felt achy; chills; sweaty; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A 54-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported ), dose 1 via an unspecified route of administration on an unspecified date as sigle dose for covid-19 immunisation. Medical history included diarrhoea. The patient mother has dementia. The patient's concomitant medications were not reported.   On an unspecified date, 36 hours after vaccine administration, the patient experienced severe diarrhea and it was the worst he had ever experienced, feverish, felt achy, chills and sweaty. The patient stated that he got first dose of Pfizer COVID vaccine and had severe reaction 36 hours afterwards. Caller states he got severe diarrhea and it was the worst he had ever experienced. He stated that he was feverish but never checked his temperature. Also, he felt achy, had chills, sweaty and this lasted for 18-24 hours at a severe level. The patient would like to know if there is any reason to be concerned with getting the vaccine and possibly having neurological issues in the future. He would further like to know if the higher your immune system and the younger you are if you are more likely to have a reaction to the Pfizer COVID vaccine. He also wanted to know if he received first dose of Pfizer COVID vaccine and had a reaction can he receive second dose of Johnson and Johnson vaccine. Outcome of the events severe diarrhea and feverish was unknown and outcome of the events felt achy, chills and sweaty was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
2/3/22 patient was scheduled for Moderna dose #1 covid vaccine. Patient had 1st dose of Astra Zeneca. Patient was administered Moderna 0.25 ml dose instead of a full dose. While documenting the vaccine I realized patient was to have a full dose. Another MA drew up the vaccine and administered the vaccine. Patient was informed she was given the wrong dose of vaccine, and she would have to be revaccinated. patient was fine with coming back. Patient had no problem or reaction to vaccine administered. i did reach out to our vaccine manager and inform her what had happened. i informed her per CDC that patient had to be revaccinated. Patient was rescheduled for vaccine. I did reach out to our vaccine manager on how to document the vaccine for correct dose. She told me to reach out to a regulatory authority for guidance. Per the RN the RA she stated patient was given wrong vaccine and wrong dose. Per CDC  guidance. she will need to be revaccinated with a Pfizer dose and not Moderna (per CDC guidance). Moderna vaccine was not approved for this use.  patient reschedule for 2/25/22 for a Pfizer vacine.
Information has been received from a nurse concerning a female patient who on an unknown date was vaccinated with a dose of GARDASIL (lot# not reported). Subsequently the patient started experiencing gallbladder problems and had to have her gallbladder removed. She was hospitalized (length and demographics not reported) and underwent surgery. The patient sought unspecified medical attention. At the time of the report, the outcome of the patient was unknown. The reporting nurse considered "experienced gallbladder problems and had to have her gallbladder removed" to be other important medical event due to surgery. Additional information has been requested.
face was flushed; forehead was red, like she sunburned; affecting her sleeping, was not able to sleep; chills; Fever of 102°F; extreme headache; nauseated; fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm; Itchy area at the injection site of about 4 inches; Itchy area at the injection site of about 4 inches and it was red; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm), SLEEP DISORDER (affecting her sleeping, was not able to sleep), FLUSHING (face was flushed), ERYTHEMA (forehead was red, like she sunburned) and VACCINATION SITE PRURITUS (Itchy area at the injection site of about 4 inches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 18-Feb-2021 at 2:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy area at the injection site of about 4 inches) and VACCINATION SITE ERYTHEMA (Itchy area at the injection site of about 4 inches and it was red). On 18-Feb-2021 at 9:00 PM, the patient experienced HEART RATE INCREASED (fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm). On 19-Feb-2021, the patient experienced NAUSEA (nauseated). On 19-Feb-2021 at 4:00 AM, the patient experienced SLEEP DISORDER (affecting her sleeping, was not able to sleep), CHILLS (chills), PYREXIA (Fever of 102°F) and HEADACHE (extreme headache). On 20-Feb-2021, the patient experienced FLUSHING (face was flushed) and ERYTHEMA (forehead was red, like she sunburned). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Fever, at an unspecified dose and frequency. On 20-Feb-2021, NAUSEA (nauseated), CHILLS (chills), PYREXIA (Fever of 102°F) and HEADACHE (extreme headache) had resolved. At the time of the report, HEART RATE INCREASED (fast heart beat and took her pulse, which was 94-95 bpm, heart beat was 105 bpm), SLEEP DISORDER (affecting her sleeping, was not able to sleep), FLUSHING (face was flushed), ERYTHEMA (forehead was red, like she sunburned), VACCINATION SITE PRURITUS (Itchy area at the injection site of about 4 inches) and VACCINATION SITE ERYTHEMA (Itchy area at the injection site of about 4 inches and it was red) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Heart rate: 94-95 (High) 94-95 bpm. On 19-Feb-2021, Body temperature: 102 °F (High) 102. On 19-Feb-2021, Heart rate: 105 (High) 105 bpm.         No concomitant medications were reported.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of VARIVAX (Merck) (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014. Co-suspect and concomitant therapies were not reported. The registered nurse reported 26 patients received doses of VARIVAX  (Merck) (from lot # K005182, expiration date 10-APR-2014 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
Child began wheezing, broke out in hives throughout trunk and extremities, with swelling of lips, and respiratory distress/chest pain. Pt given Albuterol nebulizer treatment and epinephrine IM.
2 inch x 2 inch Raised red welt with severe itching turned into red hot swollen 6"x5" hot red area- treated with benadryl, cold compress, elevation
No further AE; HCP reports VARIVAX given during a TE.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies or past medical history provided.  On 27-SEP-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, one time, lot #X007373, expiration date: 12-MAR-2025, administered for prophylaxis (strength, and route of administration were not provided); the vaccine was given during temperature excursion (Product storage error). There was no side effects, no further adverse event (AE).
This spontaneous report as received from a pharmacist refers to a 39 year old female patient. On an unknown date, the patient was vaccinated with VARIVAX (Merck) injection (dose, route and lot number were not reported). On 30-JUN-2013, the patient experienced red rash of "size of large man's hand" and "possibly a few vesicles", after the patient received VARIVAX (Merck). On a call back, the patient reported "bumps randomly over body" and blister under arm of injection site. The patient contacted the pharmacist. The patient's outcome was unknown. Additional information has been requested.
Flu like symptoms, aches, coughing, sneezing, swollen and red on site of injection.
Quadracel was used in place of Pediarix because they were out and it doesnt include Hep. B; a 4 month old patient was given Quadracel vaccine is only intended for ages 4-6 yr; Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from an other health professional.   This case involves a four months old male patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of PEDIARIX (lot C5222AA and Exp. Date 20-JUN-2019) via unknown route in the left thigh on an unspecified date.  The patient's medical history not reported and concomitant medications included HIB VACCINE CONJ (OMPC) (PEDVAXHIB) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  It was an actual medication error case due to inappropriate age at vaccine administration and wrong vaccine administered.  It was unknown whether the patient experienced any adverse event.  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.
a few days after the jab I've suffered from extreme tiredness, slept all weekend and really can't work (I do office work at home). In addition I suffer from forgetfulness and can't understand what i read well. Normally I'm very productive and read at a college level.  My doctor said i really didn't need a booster as my COVID antibody level was 139.
vitiligo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: VITILIGO (non-serious) with onset 2021, outcome "unknown".  Additional information: Patient developed vitiligo right after the Pfizer booster on 2021. He was 53-year-old male healthy never had a problem with COVID-19 (mild symptoms) but now he was hiding my face with this disease. Patient only had the vaccine done for travel.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reported that she having normal symptoms of nausea, headache, and chills no fever... on October she woke with a cough, swollen face, and a fever with running nose
pt recvd vax 14SEP95 & mom states pt devel a high pitched inconsolable cry @ 7PM;930PM mom brought pt to ER given Motrin & left ER 10:45;pt slept 1215AM-awake 3AM for feeding;t100 R: mom states cry distinctive r/t high pitched; leg swollen
PATIENT REPORTS HAVE A SORE ARM FROM SHORTLY AFTER GETTING VACCINATED TIL NOW (23 DAYS LATER) SHE STATED THAT IT IS NOT ALL THE TIME BUT AT CERTAIN TIMES SHE CAN FEEL THE SORENESS/PAIN STILL. PER PATIENT THE PAIN IS NOT ENOUGH FOR HER TO SEE A DOCTOR
Patient had 2 day h/o substernal chestpain. Patient seen in the Emergency Department on 21 FEB 2014. Patient admitted for 1 day for Pericarditis and discharged on 21 FEB 2014.
Had COVID-19 for 2 1/2 weeks. PCR test date 1/30/2021. Received my 2nd Mederna Vaccine on 11/17/2021, and AGAIN became sick.
Shingles Symptoms - itching/tingling/bumps for 1-2 days before diagnosis  Treated by drinking liquid acyclovir 4 times per day for 10 days  I have had shingles before, so I was familiar with symptoms and sought an early diagnosis.
Information has been received from a registered nurse, via a company representative, concerning an adolescent ("less than 18 years of age") female, patient, who on approximately 10-JUL-2007 ("about 3 weeks ago"), was vaccinated IM with a dose of Gardasil (Lot # not provided). Concomitant therapy may have included an additional vaccination (therapy unspecified). On approximately 10-JUL-2007, almost immediately after receiving the vaccination, the patient had a vasovagal response and developed a local reaction involving redness. At the time of this report, the outcome of the event was unknown. The nurse reported that 4-5 additional adolescent female patients also experienced a vasovagal response after vaccination with Gardasil (Lot # not provided) (WAES #0708USA00508, 0708USA00509, 0708USA00510, 0708USA00511 and 0708USA00512). Additional information has been requested.
Pt had her arm swollen at the injection site, was a little red and her arm was sore.
Pfizer COVID 19 Vaccine was administered to 2 patients after the beyond use date. Medical Associates Director of Clinical Services and Vaccine Coordinator are working with Agency to reconcile the errors and provide appropriate follow upto affected patients.
Prevnar 13 - PAINFUL DURING THE INJECTION AND HAD PAIN AND SWOLLEN ARM FOR ~1 1/2 DAYS.
This spontaneous, non-serious report received from a healthcare professional, concerned a patient, of unspecified age and sex. The patient's height, weight, medical history, concomitant medications and concurrent conditions not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin: not reported, batch/lot# 201A21A, expiry: Sep 21, 2021), dose not reported, on Sep 23, 2021 for COVID-19 immunization. On Sep 23, 2021, patient administered expired vaccine. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The outcome of administered expired vaccine: not reported. This case (from the same reporter), linked to 20211012141, 20211011801, 20211012383 and 20211012114. The product quality complaint number was 90000196302.
pt recvd vax; diffuse urticarial eruptions of face, trunk, extremities, associated w/ fever;
Swelling in the right upper arm beginning evening of 09/28/2011; onset of redness 09/29/2011; evaluated on 09/30/2011 and advised to use ice packs for swelling, Benadryl for local reaction, and to go to ER with swelling of face or worsening of symptoms.
PATIENT COMPLAINED OF DIZZINESS AND BLURRED VISION AFTER 5 MINUTES OF RECIEVING THE VACCINE. AFTER PHARMACIST CONSULTATION, IT WAS DETERMINED THAT THE PATIENT HAS A PREVIOUS HISTORY OF FAINTING WITH NEEDLES UPON BLOODWORK BUT NOT COMMONLY WITH VACCINES. THE PATIENT ALSO RELAYED TO THE PHARMACIST THAT SHE DID NOT EAT ANYTHING SINCE THE MORNING AND ALL SHE HAD TO EAT IN THE MORNING WAS A BANANA. WE GAVE HER WATER AND MOVED HER TO A ROOM IN WHICH SHE WAS ABLE TO REMOVE HER MASK AND BREATHE EASIER. SHE THEN REPORTED OF TINGLING IN HER UPPER LIP. SHE WAS GIVEN A SNACK TO ASSIST WITH SYMPTOMS OF POSSIBLY HYPOGLYCEMIA. WE MONITORED HER FOR ANOTHER 15 MINUTES CONTINUOUSLY CHECKING ON HER AND HER SYMPTOMS ALL STARTED IMPROVING AND RESIDING. AFTER 30 MINUTES OF CLOSE MONITORING THE PATIENT FELT WELL ENOUGH TO GO HOME.
This was first dose. Second dose effects are more severe and still are present.  fever, increased pain ; Fibromyalgis flare. Dizziness, extreme fatigue, increased chronic cough, headache, loss of majority of taste and smell
RPh administered dose#1 of Pfizer vaccine to patient. Patient was walking toward front of the store after ~15 minute observation.  She felt faint and fell to floor. She regained consciousness within a minute or so and stated she was not injured from fall.  Blood pressure was normal. Paramedics were called to verify patient was OK.  She was given the all clear and left with her mother.
Patient awoke during night with shakiness, headache, and vomited x's one 3 days after vaccination with second dose of Gardasil. Episode lasted approx one hour. Pt has IDDM, BS normal at that time. Same occurred after dose #1 which was reported as separate event.
83y.o. female who presentswith PMH of TIA, HTN, CVA with residual LLE weakness, parkinsonism presented to the ER with generalized weakness and was found to have COVID infection along with elevated troponins, bradycardia and prolonged QTC.  Infectious disease was consulted and remdesivir 4 doses were given with improvement in her symptoms.  Cardiology was consulted for possible NSTEMI versus viral myocarditis.  Was treated with IV heparin infusion for 48 hours, echocardiogram was stable with preserved EF without wall motion abnormalities.  Once out of isolation, stress test was done which was negative for any reversible ischemia.  PT OT evaluation and PMNR evaluation was done and recommended subacute rehab which was negative for any reversible ischemia.  PT OT evaluation and PMNR evaluation was done and recommended subacute rehab which was arranged on discharge.
Patient was administered first dose of the Shingrix immunization series.  A few minutes later she reported feeling dizzy.  She was asked if she had eaten anything recently and she said a boost drink for lunch.  Upon offering her a drink of water and/or a snack -- the patient rolled back in her chair with her eyes closed.  911 was dispatched.  Her sister was talking to her and encouraging her to concentrate on her breathing and her husband went upstairs to get nurses from cardiology.  The patient reported difficulty breathing and pain in her chest.  The nurses from cardiology also saw a second episode where the patient rolled back in her chair with her eyes closed.  The ambulance arrived and EMS took the patient to evaluate.
got two shots, still get shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The case was reported by the patient . The age at vaccination was not reported. The patient got the two shots of Shingrix and still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt got Moderna COVID-19 bivalent vaccine 1st on left arm. After receiving bivalent booster, pt mentioned gets nervous w/ shots. Has fainted before to flu shot. Immunizer asked if ok to continue w/ flu shot, patient verbalized consent. Immunizer preppred left arm for flu shot about 1in above 1st shot. Administered Flulaval Quad 22-23 vaccine on left arm & as placing bandaid on arm, pt mentioned wanting to lie down then slide off chair & fainted. Recovered after a few seconds. Pt rested for 30min.
Pt recv vax in 4/97; the next day pt exp hives w/ itching all over body x2 day.
Papillary Thyroid Carcinoma; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 12:00 (Lot number: FJ6369) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: OLMESARTAN. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot No: EL9261, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 04Feb2021, when the patient was 35 years old, for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Lot No: EL9261, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 21Feb2021, when the patient was 35 years old, for COVID-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered".  The following information was reported: PAPILLARY THYROID CANCER (medically significant) with onset 14Feb2022, outcome "not recovered", described as "Papillary Thyroid Carcinoma". The event "papillary thyroid carcinoma" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Nasal Swab. Therapeutic measures were taken as a result of papillary thyroid cancer. with Total thyroidectomy and RAI.  Clinical course: The patient did not received other vaccine in four weeks, and was treated with Total thyroidectomy and RAI. The patient had covid prior to vaccination and was tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  event papillary thyroid carcinoma and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Pt states 4 hrs hrs after vaccination felt very ill - very tired without appetite - went to bed. Became nauseous - threw up violently then became chilled unable to get warm - lasted 4 hrs. then better. No soreness, rash, or swelling at injection site. 2/15 went to PMD for sore throat on Z Pack.
it was not noted or mentioned after the Pfizer vaccine was given that patient's first dose was the moderna brand on 6/18/2021