chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; skin rash (erythema multiforme). DX: Stevens-Johnson syndrome7/20/06 Received medical records from reporter/provider which reveal that patient was in good health when received vax.8/3/06 Records received from hospital which reveal patient admitted 7/6/06.  D/C summary reveals final diagnosis of Stevens-Johnson Syndrome related to Td Vax.  Temp 104.7 on admit w/lesions on face, tongue, eyes w/brawny papular rash w/urticaria & then extended over the trunk & spotty areas on arms & legs.Atmitted to ICU & eval by ophthalmology, surgery ID & dermatology.  Tx w/steroids both IV & PO.  Gradually improved & was d/c home on 7/16/06 on tapering steroids./ss
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. In July 2014 the patients were vaccinated with PEDVAXHIB (dose, route of administration and lot # were reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Nausea; Achy Joints; This is a spontaneous report received from a non-contactable consumer or other non hcp. A 30-years-old non-pregnant female patient received BNT162B2 (formulation: solution of injection), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history included BNT162B2 (formulation: solution of injection), dose 1 via an unspecified route of administration, administered in Arm Left on 19Jan2021, at 13:30 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not tested for COVID post vaccination. On 10Feb2021, 12 hours after vaccination, the patient experienced nausea and achy joints. The patient did not receive any treatment for events. The patient recovered from events on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained..
pt state throat felt tightened, had to clear throat frequently to be comfortable. paramedics were called to assist
This spontaneous report as received from a physician refers to his wife, a female patient of unknown age. No concurrent conditions or medical history were provided. On 19-DEC-2014, the patient was vaccinated with an improperly stored dose of ZOSTAVAX injection (strength, dose, route of administration, lot# and expiry date unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Around 5 pm the evening of injection, myalgia, joint pain, and muscle aches started.  By 8 pm, it felt like the flu:  fatigue, headache, shivering, fever, and overall achiness .  Next morning, 8 am: diarrhea, queasiness, continued myalgia, joint pain, muscle aches, fever, fatigue, headache, shivering (flu like symptoms and misery).  Took 2 pills of loperamide HCL at 10:30 am, and another at 11:30 am, which resolved the diarrhea.   Slept from 12:30pm to about 5pm.  By then, other symptoms started to subside.  By 8pm, queasiness and fatigue remained.  By morning of day 2, only sensitive stomach remained, which resolved itself by 2pm.
SICKNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sickness. Treatment medications (dates unspecified) included: chlorphenamine maleate/paracetamol/phenylephrine hydrochloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sickness. This report was non-serious.
We would like to report that this death occurred within one week of 2 month vaccines. Coroner reported cause of death undetermined - possible SIDS vs. co-sleeping.
A physician reported the occurrence of injection site cellulitis in a 17 month old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis absorbed for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. The subject was described as a well child. The subject had no adverse experiences following previous immunizations. On an unspecified date, the subject received an injection of Infanrix (lot DTPA382B2). Subsequently, on 2/13/03, the subject developed a severe local reaction characterized by swelling, redness, and pain. The physician made a diagnosis of injection site cellulitis. The injection site cellulitis resolved after an unspecified period of time.
vaccine administered 5/24/2022, beyond use date was 4/28/2022, expiration date was 5/31/2022
My daughter blacked out at soccer practice. Her over health began declining in the fall of 2008.  She gets Strep throat constantly (even after a tonsillectomy), she began getting cold sores (Herpes simplex 1) and now gets them all over her face, fatigue, hair loss, inability to fight off any infection, reflux and digestive problems, muscle tingling, soft tissue injuries that will not heal as well as bone fractures that will not heal.  She had a grand mal seizure in Jan. 2010 from what we expect to be mold toxicity (her rental house flooded during winter break and the mold levels were tested at 200 times passed what is considered to be toxic).
Possible adjuvant  administered by itself; Possible adjuvant  administered by itself; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Possible adjuvant  administered by itself) and inappropriate dose of vaccine administered (Verbatim: Possible adjuvant administered by itself). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 02-MAR-2023 The reporter asked about whether Shingrix adjuvant was sold separately due to there being two extra vials of powder.  The reporter stated she did not feel like adjuvant was given by itself.  This was just being reported as a possible adverse event of (possible) adjuvant being administered by itself to be on the safe side (compliance).  Health care professional feeling like it was not administered by itself (diluent).  Health care professional did not feel like an adverse event occurred. This was being reported at the guidance of the manager to avoid non-compliance. No other information was provided. The reporter did not consent to follow-up.  The reporter stated she does not feel like adjuvant was given by itself which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case was linked with case US2023034040, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2023034040:Same reporter. Patient 1
It was reported that a 4 year-old male received Tripedia(lot# U0549CA). Patient developed local reaction of redness around the injection site. Physician treated with ice and exercise.
Felt a strange sensation in left neck, faceand sinus; Tonsils are sore; feel a strange sensation in my left neck, face and sinus.; This is a spontaneous report from a contactable consumer, the patient. A 39-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm right on 02Apr2021 at 12:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nuts of all kinds and swimming fish (not shellfish) allergy. Patient received other medications in two weeks which included paracetamol (TYLENOL), guaifenesin (MUCINEX), ibuprofen (ADVIL), paracetamol; acetylsalicylic acid; caffeine (EXCEDERINE) all from an unknown date for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 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 02Apr2021 at 13:30, the patient experienced a strange sensation in his left neck, face and sinus. It was subtle. More alarming was that his tonsils were soar. And this had gotten progressively worse as the day had gone on. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of neck strange feeling, lymph node pain, feeling strange was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a patient who experienced heavy menstrual bleeding about a year ago after receiving a dose of GARDASIL. This is one of several reports from the same source. Additional information has been requested.
Around the shot, it is itching; It was sore/still sore when she touches it; Around the shot, it has been swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Around the shot, it is itching), VACCINATION SITE PAIN (It was sore/still sore when she touches it) and VACCINATION SITE SWELLING (Around the shot, it has been swollen) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was reported that patient has never been diagnosed/tested positive for COVID-19.  Concurrent medical conditions included Tremor. Concomitant products included PRIMIDONE for Tremor, LISINOPRIL, METFORMIN, LEVOTHYROXINE, VITAMIN A [RETINOL], VITAMIN D [VITAMIN D NOS], FISH OIL, CALCIUM and VITAMINS NOS (MULTIVITAMINUM) for an unknown indication.    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. In October 2022, the patient experienced VACCINATION SITE PRURITUS (Around the shot, it is itching), VACCINATION SITE PAIN (It was sore/still sore when she touches it) and VACCINATION SITE SWELLING (Around the shot, it has been swollen). At the time of the report, VACCINATION SITE PRURITUS (Around the shot, it is itching) and VACCINATION SITE SWELLING (Around the shot, it has been swollen) outcome was unknown and VACCINATION SITE PAIN (It was sore/still sore when she touches it) had not resolved.            No Medical History information was reported.  The vaccine patient received was second booster.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Patient's mother called the following week (5 days) post injections.  Patient developed hive on left thigh about 2-3 days after injection.  Patient also saw physician 1 day after injection and started Claritin at that time.  As of today hives were going away.
3hrs p/vax eyes jerking; teeth chattering; body jerking-esp arm & legs; high fever-temp not taken but pt felt very hot; given DPH & APAP;
Pt received a DT booster and developed a large erythematous area about 10 cm in diameter around injection site that is painful to touch and movement.
chills, nausea,metallic taste, half an hour after shot felt sick and had chills bad taste in mouth. lasted that day and next day. felt fine after that
Abnormal menstruation for several months. I had an extremely heavy flow, then no period the next month. Cycle has yet to return to normal.
This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's past medical history included intrauterine device (iud), and other pre-existing medical conditions included the patient did not have any medical history. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced tired. On 12-APR-2021, the subject experienced cramps. Treatment medications included: ibuprofen. On 12-APR-2021 16:00, the subject experienced fever. On 14-APR-2021 09:00, the subject experienced vaginal bleeding. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired on 13-APR-2021, and fever on 12-APR-2021, had not recovered from vaginal bleeding, and the outcome of cramps was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Through a CT scan, the doctor determined I had Acute Appendicitis; This is a spontaneous report from a contactable consumer (Patient). A 57-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), dose 1 via an unspecified route of administration, administered in Arm Right on 12Mar2021 16:30 (Lot Number: EN6199) as single dose for covid-19 immunisation. Facility type Vaccine was Hospital. Medical history was none, no known allergies. The patient didn't have COVID prior to vaccination. Concomitant medications in two weeks included metoprolol succinate, propafenone and sertraline, all taken for an unspecified indication, start and stop date were not reported. There were no other vaccine in four weeks. Patient received his first dose on 12Mar2021. He started getting abdominal pains on the morning of 14Mar2021 02:00 AM. On 15Mar2021 he started having severe diarrhea. By 16Mar2021 the severe diarrhea continued which was nothing but water. On 17Mar2021 he went to the emergency room at (Name) .Through a CT scan, the doctor determined he had Acute Appendicitis. On the night of 17Mar2021 he had his appendix removed. The event resulted in hospitalization for 2 days. COVID test post vaccination included Nasal Swab on 17Mar2021 with negative result. The outcome of the event was recovering.  Follow-Up (01Apr2021): Follow-up attempts are completed. No further information is expected.
fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and experinced fever.
Smallpox blister was opened prematurely after 1 wk. Swelling began. Redness spread. 6 days later bumps swelled across chest and back.
8 days after vaccine she developed a rash in her vaginal area that improved with nystatin. She woke up on 6/17/19 with what looks like 3 bites on her right thigh and also a rash on her torso. Afebrile. Returned to office for a worsening immunization reaction in the right thigh on 6/18/19. Patient received MMR  in right thigh 6/7/19.  Seen yesterday for rash and red bump on thigh-dx with vaccine reaction. -today with worsening redness on R upper-lateral aspect of thigh-started on Sunday. Seems painful and warm. -Generalized rash since yesterday.  -Last tylenol x 3.5 hours ago. For discomfort -no fever -looser stool x 1 yesterday. None today.
Patient's mother came to clinic with his sibling.  She refused to allow this child to get an IPV.  After questioning, she stated patient had ran a high fever after he was given an IPV.  She stated he had a IPV on 8/22/08 in A.M. between 8 & 10 and by noon he had a temperature of 104.2, this lasted 4 days.  He was lethargic and crying.  She called Call-A-Nurse and spoke with her doctor during this time, he was not seen by anyone.  She stated she alternated Tylenol and Motrin dosages, as she was instructed, until the fever subsided.
SUSPECTED COVID-19 INFECTION; DEPRESSIVE STATES; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection and depressive states. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and depressive states was not reported. This report was non-serious. This case, from the same reporter is linked to 20220752365. This report was associated with a product quality complaint: 90000243836.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
a patient was administered a properly stored but expired dose of PNEUMOVAX 23; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 24-JUL-2020 the patient was vaccinated with a properly stored but expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dose, lot # R012550, expiration date 25-JAN-2020; dose and route was not reported) for prophylaxis (experienced expired product administered). No additional event information. The product was not available for investigation (obtain was reported as false). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R012550; expirationdate: 25-JAN-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
resident by mixing the lypophilized powder with sterile water for injection versus the diluent vial provided.; lypophilized powder mixed with sterile water was administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (the first dose was given correctly on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.     Additional Information: GSK receipt date: 29-SEP-2022 Reporter's comment: The reporter was a consultant pharmacist and had reported that Shingrix was administered to a resident patient of the nursing building by mixing the lyophilized powder with sterile water for injection versus the diluent vial provided. Note that the first dose was given correctly but the second dose was given as stated above. Reporter had inquired to ensure that the dose was properly absorbed when the incorrect diluent was used. The reporter had doubted if there were any studies or any definitive answer, but he/she had attempted to provide guidance to the nursing staff so that they can administer an additional vaccine (and at the right time/schedule) if a third dose would be required. The follow-up was not possible as per the process convention. Additional supportive information: The Shingrix dose was administered to a patient by mixing the lyophilized powder with sterile water for injection versus the diluent vial provided which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
It's been on going since the dose 3. I have had problems with my bowel movements. It much less then my prior movements. It be in little pieces and hard to move. I don't go as regular as I did before getting the vaccine. Also, my urine has been dark in color, maybe a little orange in color. Not every time I go. I had a sore arm and some chills and a low grade fever.
Herpes zoster outbreak. Dermatome 3/4 right chest. 8/25/07.
had covid within the last 2 years; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (had covid within the last 2 years) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (had covid within the last 2 years). At the time of the report, COVID-19 (had covid within the last 2 years) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that unlike the 8 people who were vaccinated and had covid within the last 2 years. Out of the 8 people 3 people received Moderna vaccine(S) and the others Pfizer. Patient nor product details were available for the 3 patients who received the Moderna vaccine. No treatment information was provided. This case is reported for patient 1 out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-748522 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748522:Patient 2 out of 3 US-MODERNATX, INC.-MOD-2023-748525:Patient 3 out of 3
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. On 21-NOV-2014, the patient was vaccinated with a dose of M-M-R II (route, dose, frequency and lot # not reported) which had undergone an temperature excursion. This is one of several reports from the same source. Additional information has been requested.