chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable nurse. A 6-year-old patient of an unspecified ethnicity and gender received the first, second, third, and fourth doses of PREVNAR; all via unspecified routes of administration on unspecified dates at single doses. Medical history included allergies, bronchitis, and being sick all the time. The patient's concomitant medications were not reported. On an unknown date, the patient experienced drug ineffective, recurrent infections that have mostly been respiratory with ear and throat infections, and the patient's pneumococcal titers were checked and they were low for several serotypes. The titer results for the pneumococcal serotypes were: type 1 = 10.1, type 3 = 5.2, type 4 = 0.2, type 8 = 0.2, type 9 = 0.7, type 12 less than 0.1, type 14 = 0.4, type 19 = 3.1, type 23 = 1.1, type 26 = 0.3, type 51 = 0.8, type 56 (18C) = 1.3, type 57 (19A) = 2.9, and type 68 (9V) = 1.2. Therapeutic measures were taken as a result of recurrent infections that have mostly been respiratory with ear and throat infections and included treatment with an urgent tonsillectomy. The clinical outcome of the events, drug ineffective, recurrent infections that have mostly been respiratory with ear and throat infections, and the patient's pneumococcal titers were checked and they were low for several serotypes, were unknown. Follow-up (07Jan2016): Follow-up attempts completed. No further information expected.
Administered an Expired Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 21-year-old female patient who received HAV (Havrix adult) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th June 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 17th June 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 08-Aug-2022 Reporter comment: The pharmacist called to inquired what the time length for revaccination was. The pharmacist reported that a patient was administered with an expired dose of Havrix adult. The pharmacist was unable to provide vaccine details but stated expired Havrix was administered over 30 days from expiration but not over 90 days of expiration date. No additional details provided. The reporter did not consent to follow up. Additional Supportive Information: The patient was administered an expired dose of Havrix adult, which led to expired vaccine used.
Red rash under arms, under breast, part of chest, crotch area where legs attach to body, butt crack/Extra warm areas
Patient spoke to pharmacist on 4/18/16 regarding her arms being sore for a long time after flu shot administered 3 years ago.
PALE; WEAK; COULDN'T SLEEP; FLU-LIKE SYMPTOMS/HEADACHE/FATIGUE/LOST APPETITE/GENERALIZED BODY ACHES/SWEATING/DIZZINESS; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthmatic, and low iron, and other pre-existing medical conditions included 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: 041A21A, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced flu-like symptoms/headache/fatigue/lost appetite/generalized body aches/sweating/dizziness. On 10-APR-2021, the subject experienced couldn't sleep. On 11-APR-2021, the subject experienced weak. On 13-APR-2021, the subject experienced pale. Laboratory data included: Body temperature (NR: not provided) 97.1 F. Treatment medications (dates unspecified) included: paracetamol, loratadine, and diphenhydramine hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weak, and flu-like symptoms/headache/fatigue/lost appetite/generalized body aches/sweating/dizziness, and the outcome of couldn't sleep and pale was not reported. This report was non-serious.
There was no adverse event. Reporting due to the recommendation of the FDA that we are no longer giving monovalent vaccine
tingling in cheeks; nasolabial folds; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA (tingling in cheeks) and SKIN WRINKLING (nasolabial folds) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included HYALURONIC ACID, LIDOCAINE (RESTYLANE L) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in cheeks) and SKIN WRINKLING (nasolabial folds). At the time of the report, PARAESTHESIA (tingling in cheeks) and SKIN WRINKLING (nasolabial folds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported
I was going to the bathroom and I got really hot. My heart started to race and I ended up passing out. I was transported to the hospital and admitted over the night for observation. Ten days later, I passed out again and was admitted to the hospital again.  I've had a couple of mini episodes where I have had to lay down and elevate my legs to keep from passing out
bradycardia, diaphoresis, paleness, anxiety 10 minutes after injection Treatment: hydration, laying down flat
This spontaneous report was received from a Nurse, concerning her 16 year old son. The patient did not have medical history, concomitant medication, drug reactions or allergies. On 27-JUL-2017, the patient received one dose of GARDASIL 9, intramuscular injection, in an administration schedule of 3 doses on 0, 2 and 6 months, for prevention of Human Papilloma Virus (HPV) (lot number and expiration date were not reported). After receiving the vaccine on 27-JUL-2017, the injection site was red, hot and it hurt terribly. The nurse also stated that the skin around the injection site was hard and raised and caused his entire arm to feel weak for seven days. The patient did not sought medical attention, no lab diagnostics or studies were performed and no treatment was given for the events. On 27-JUL-2017, therapy with GARDASIL 9 was discontinued. On 03-AUG-2017, the patient recovered from arm weakness and he recovered from the remaining events on an unknown date. The reporter did not assess the causal relationship between GARDASIL 9 and the events.
CDC reports: 8 mo infant immunized 6MAR90, same day developed fever to 105.8 & inject site - slightly red, lethargic for 3 days, limp. On 10MAR90, had rash, other than at inject site.
Patient complained of difficulty breathing after receiving dose. Onsite EMS assisted the patient and transported them to the hospital.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 12May2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) negative; (12May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Clinical Course: Patient had rebound mild symptoms of 12May2022 and tested positive again on 2 at home tests. I had already tested negative on 09May2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events COVID-19 , DRUG INEFFECTIVE and the administration of the vaccine cannot be excluded.
Seizure with a fall and LOC on 12/22/2022 requiring an ER visit, and status epileptics on 1/6/2023 requiring an intubation and admission for 3 days.  Patient had eventual recovery to baseline.  There was no obvious medical reason found for this cluster of seizures that was an unusual exacerbation of her normal epilepsy control.
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. On 28-APR-2015, the patient was vaccinated with a first dose of GARDASIL dose, route and lot# were not reported. On 08-MAY-2015, the patient received a second dose of GARDASIL dose, route, and lot# were not reported. No adverse effects were reported. Additional information has been requested.
Several hours post vax, the pt stated she "broke" out in a rash. The pt called the ER on 9/22/00. Rash was still there.
STATES THAT HE REMEMBERS A SORE ARM, BUT NOT SURE WHICH SIDE IT WAS ON.  IT WAS BETTER THE SECOND DAY AFTER SHOTS, WHICH WOULD HAVE BEEN OCTOBER 22, 2022.
Reports developing area of swelling of her forehead which progressed to generalized swelling on various areas of her body with urticaria and pruritus within 2-4 hrs of receiving her anthrax immunization. She reports no problems with 3 prior anthrax vaccines.
low fever (<100.0); joints ache; slight headache; injection site is sore; This is a spontaneous report from a contactable consumer (patient, self-reported). A 47-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247 and expiration date was not reported), via unspecified route of administration in left arm on 18Feb2021 at 13:00, as single dose for COVID-19 immunisation. The patient's medical history included AERD and asthma. The concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247 and expiration date was not reported), via unspecified route of administration in left arm on 28Jan2021 at 13:30, as single dose for COVID-19 immunisation. On 18Feb2021 at 23:00, the patient experienced low fever (<100.0), joints ache, slight headache and injection site sore. The adverse event does not required the treatment. No COVID prior vaccination and not COVID does not tested post vaccination. The outcome of the events was not recovered.
Swollen, red, tense right arm below vaccine site all the way to elbow and onset 24 hours of vaccine. Lasted 3 days.
Very sore right arm where shot was adminstered approx. 4 hours late very hoarse and lots of phlegm couldn't spit much out and had to swollow most of it approx. 1 hour later was freezing cold could not get warm started throwing up which led to intense sweating threw up again about 30 minutes later was able to fall asleep for 30 mins or so woke up drenched in sweat. Headache, body aches sore all the way down from my right shoulder to my elbow and down to my wrist.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was vaccinated with an expired dose of PEDVAXHIB on 02-OCT-2012. Route was not reported. Lot # was 666299/1515Y with an expiry date of 27-SEP-2012. No symptoms were reported. Additional information is not expected.
The pt developed simple febrile seizure two days post immunizations also had brief apnea and taken by ambulance to ER. No treatment necessary/
Patient had some mild fatigue/body aches the next day, but symptoms are now completely gone back to normal. We gave him the booster dose for the moderna but patient was not immunocompromised. It was in error. His second dose of the moderna was back in March. Patient is aware, doctor is aware.
Patient given 2nd Pfizer Bivalent booster. No treatment was necessary. Patient was notified and she reported  no adverse reaction.
Received Flu vaccine 9/23/09, approximately 10/5 developed bilateral weakness with some difficulty walking. 11/16/09 ER records received for dates 10/13/09 to 10/14/09. DX: weakness, fatigue. Pt. presented to ER with c/o LE weakness x8 days stated had flu vax 10 days ago. LE weakness started in left leg then right.
Started with local vaccine reaction at site in left shoulder. Progressed to angioedema that involved entire left arm, left chest to midline and lower neck.
had a little pain in the arm; throat was a little sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2021 (Lot number: EL9264) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure measurement (ongoing); AMLODIPINE taken for blood pressure measurement (ongoing); ATORVASTATIN taken for blood pressure measurement (ongoing); METFORMIN taken for diabetes mellitus (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "had a little pain in the arm"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "throat was a little sore". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She was scared she was going to get Covid-19; she is an older woman. She was on other Products. She had no Prior Vaccinations (within 4 weeks), Reported as none for her AE(s) following prior vaccinations. Relevant Tests was None.  She is calling regarding the Pfizer Covid-19 shot. She had both of her shots all ready. She had them back in Feb2021. She is trying to find out when she should get the booster shot. She did not have any ill effects from the first shot. She just had a little pain in the arm and her throat was a little sore. That was it, everything else was fine. She has been trying to call where she got the shots from to make an appointment for her booster. She is fine, otherwise, she has aches and pains, of course. She is at that age now where she gets aches and pains. She has had that for a while, like when she sits for a long time or has been walking a long time.  She had a colonoscopy that came out very good, that is all. She barely gets sick. Every now and then she gets a cold, but she is not sickly. While reporting side effects from the Pfizer Covid-19 vaccine, caller mentioned she takes losartan for blood pressure and that her blood pressure fluctuates so bad. She has been taking Losartan for a while now for her blood pressure, it fluctuates so bad. It has been over 3 or 4 years. She Has been taking Amlodipine for 3 or 4 years. she has been taking all these damn pills for blood pressure. Atorvastatin has been taking about the same time, 3 or 4 years, maybe a little longer. She has been taking Metformin about 3 years. Treatment for Just her blood pressure and diabetes medication, nothing specifically for these symptoms.   No follow-up attempts are possible. No further information is expected.
Right arm (pneumovax site) caused reaction locally. Left arm (flu shot) unremarkable. Patient went to ER with pain & sweeling & fever to 101.5, ER MD started her in antibiotics & narcotics. Family reported decreased urine output and persistant pain & swelling.
Patient claims she collapsed at home about 11:00 pm that same evening.  She was "in and out of consciousness".  She had no control from the waist down.  When she tried to walk, she couldn't move her legs.  In addition, she had no control over her bowels or bladder and she began vomiting.  She lay on the floor until about 7:00 pm the next day.  She was finally able to call 911 and paramedics transported her to Holy Family Hospital ER.  They didn't have any available beds so, they took her to the ER.  This was May 23rd.   From the hospital, she was eventually transported on May 29th where she stayed until June 5th.
Vaccine breakthrough, symptomatic.   Inpatient admit 9/7-9/12.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 20-AUG-2014 the patient was inadvertently administered an expired dose of PNEUMOVAX 23 lot # J009827, expiry date 10-AUG-2014 (dose and route not reported). No adverse effects reported. Additional information has been requested.
Fever (chills, sweat, chills, sweat through the night), headache, body ache, aching behind eyes, bone pain
Confused MR/DD pt was given vaccine by MA without name and DOB being verified therefore she had the wrong patient. Pt was given moderna booster dose.  After investigation,  pt needed 1st dose. 2nd 0.25ml dose was given to equal primary dose. No adverse reactions noted with either dose. Staff was present with patient well over an hour.
received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021); received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021); This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) and PRODUCT STORAGE ERROR (received a vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021)) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided by the reporter.  No treatment information was provided.
Several hours after receiving the MMR Vaccine, he got fever, malaise, and irritability. The fever lasted about one day. The malaise lasted two days. For the next 10-14 days he was very irritable, it was difficult for him to cooperate, and he was angry. Usually, he is an enthusiastic, cooperative kid.
10-15 flat rash appeared on abd & back last Saturday;no fever or feeling weak;
Got my shots but still got a bad case of shingles/Suspected vaccination failure; Got a bad case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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 Shingles vaccine.     Additional Information: GSK Receipt date: 29-APR-2022 Reporters comment: The patient self-reported the case via interactive digital media. The patient got Shingles shots and still got a bad case of shingles. The patient asked, was there a booster he/she should get. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available.
The dizziness was incapacitating; Had 100.6 temp and body aches; Had 100.6 temp and body aches; Sore arm; Temporary shortness of breath; This is a spontaneous report from a contactable other hcp. A 60-years-old female patient received BNT162B2 (COMIRNATY) (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, (Lot Number: EL3248 expiry date was not reported) dose 1 via intramuscularly administered at Arm Right on 13Jan2021 11:30 as 1st Dose, Single for Covid-19 immunization.The patient's procedural history included tonsillectomy and adenoidectomy, total abdominal hysterectomy, salpingo-oopherectomy and cholesytectomy (01Jan2004). The patient's medical history included mononucleosis (from 01Jun2020 to 01Mar2021). The patient's concurrent conditions noted hypertension (from 01Jan2013) and hot flashes. The patient family history included hypertension for maternal grandmother.Concomitant medications included . The patient had reaction  immediately after 1st vaccine and she felt short of breath that evening on 13Jan2021. The patient had a sore arm 14Jan2021 (the next day).  On an unspecified date, the patient had dizziness which was incapacitating and could not drive and also had 100.6 temp and body aches. The patient unable to stand without passing out.The patient received Dramamine for dizziness and Nyquil for fever and body aches and temperature.The patient received Nyquil (doxylamine-DM-acetaminophen) and went to bed. The patient reported that she was okay. The outcome of all the events was resolved on an unspecified date in 2021.     Causal relationship:Is there a reasonable possibility that the event is related to suspect product: Yes  No follow-up attempts are possible. No further information is expected.  Comments/narrative: Reaction immediately after 1st vaccine. Felt short of breath that evening, took Nyquil went to bed. Besides a sore arm the next day, I was okay. Approximately 12 hours after second vaccine, I was achy, dizzy and had temperature of 100.6. Did go to walk but by the afternoon, felt bad enough and went home. The next day, was still dizzy, achy and was vasovagal with standing.Stayed home from work. The 3rd day, I felt ok, went to work.