chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Herpes zoster; Information has been received on 09-APR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 25-OCT-2015, the patient was administered the Zoster Vaccine Live (ZOSTAVAX) (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: herpes zoster. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related.   Additional information has been requested.
event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (event related to receiving their Moderna COVID-19 vaccine 4 days beyond the recommended expiration dat) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment details were reported.
Approximately 15 minutes after patient received 4 vaccines, patient had a 5 second "seizure-like" episode, eyes rolling back, head extremities shaking.  Patient observed in office for 3 hours - recovered well at intervention.  On 12/3/07, mom reported patient did well over the weekend at home.
high fever; vomiting; This is a spontaneous report from a contactable physician via Pfizer Sales Representative.   A 16-year-old female patient received on an unspecified date at same visit, meningococcal group b rlp2086 (TRUMENBA) at single dose and meningococcal vaccine A/C/Y/W (MCV4), both for immunization. The patient medical history and concomitant medications were not reported. On an unknown date after vaccination, the patient experienced high fever and vomiting, both non serious. The final outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained
Moderna pediatric 6-11 years old primary series was given instead of the Moderna pediatric 6-11 years old bivalent booster. No adverse event reported.
Cerebral venous thrombosis presenting with persistent, severe, localised headache, aphasia and right peripheral facial paralysis. Symptoms resolved after treatment with LMWH at 100U/kg twice daily for 14 days, followed by oral anticoagulants for 30 days.
Severe abdominal cramping, arthralgia, and diarrhea right after eating breakfast the morning after she received the influenza vaccine.
March 19: fever of unknown origin, chills, fever reached 101.0F; resolved with Tylenol and no further symptoms that day  March 29: second fever of unknown origin, chill, fever reached 101.0F; fever resolved on its own; Tylenol taken for subsequent migraine
pulmonary congestion & edema,bronchopulmonary dysplasia, Child not acting right all day, as per family, stopped breathing in front of mom, found in cardiac arrest by EMT who began CPR,pt found /w distended abdomen, decompressed manually
Chills; shivering; shaking; very high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), CHILLS (shivering), TREMOR (shaking) and HYPERTENSION (very high blood pressure) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced CHILLS (Chills), CHILLS (shivering), TREMOR (shaking) and HYPERTENSION (very high blood pressure). At the time of the report, CHILLS (Chills), CHILLS (shivering), TREMOR (shaking) and HYPERTENSION (very high blood pressure) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD21-076620 (Linked Report).  Treatment products included metoprolol 50 mg.; Sender's Comments:  MOD21-076620:MOD-2021-078027 -1st dose of vaccine
From telephone contact on 3/6/02 at a manufacturer, it was reported that a 41 y.o. female PT received Rabies Post Exposure back in October 2001. A few days after her 4th dose she developed achy flu-like symptoms which lasted about 2 weeks. She never completed the series. At 3 mts she was diagnosed w/arthritis and in her words: bubbles or blisters behind her knees that the doctor told her was the onset of arthritis. She wanted to know how long this pain from the vaccine will last. She did not want to do this report. She said her doctor put her on anti-inflammatory drug called Feldine and also pain medication which she did not know the name of. Her back, arms, knees and shoulders are involved but not her hands.
large red rash around injection site; The spot is hard; The spot is itchy; hot spots; This case was reported by a consumer via call center representative and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 -3 months ago).   On 8th December 2019, the patient received the 2nd dose of Shingrix. On 11th December 2019, 3 days after receiving Shingrix, the patient experienced red rash, induration, itchy rash and heat rash. On an unknown date, the outcome of the red rash, induration, itchy rash and heat rash were not recovered/not resolved.   It was unknown if the reporter considered the red rash, induration, itchy rash and heat rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had a large red rash, the spot was 4 by 4 inches around the injection site.  The spot was hot, hard and itchy.  The patient could not lay on it or put pressure on it.  The spot seems to be growing a bit.
Shortly after vaccination, started having falls. Noted progressive weakness and have been diagnosed presumptively with ALS.
Patient (DOB 10/11/2019) received the Pfizer 6m-4y (Maroon cap) vaccine from facility for his second dose, following a first dose of Moderna 6m-5y (Blue cap, magenta label). Vaccine info chit was marked as 'Pfizer', we verbally confirmed a Pfizer dose of the vaccine with patient's father and the dose was administered with no issue. Patient's father noted after vaccination the discrepancy between the dose stickers and brought the issue to the attention of staff. The discrepancy was brought to the attention of pharmacist, and confirmation was made that the vaccine administered was Pfizer. Pharmacist then spoke with patient's father regarding the error, the CDC recommendation in this situation, and next steps for the patient. Patient's father expressed understanding, and patient has an appointment for a third dose in 8 weeks, in accordance with Appendix D of the CDC's clinical recommendations.
Per patient report, "Covid Arm" first noted on day eight after vaccination. Arm became, "Red, hard, raised & warm area near injection site." Symptoms began to improve on day 11. On day nine after injection, patient noted that her left eyelid started to swell, becoming "a bit more swollen each day," and improving after "three to four days."
Pt received Pfizer x2. Pt was tested COVID + on 9/16 and hospitalized on 9/17/21. Pt was hypoxic and received remdesivir and dexamethasone.
IMMEDIATELY AFTER MY VACCINE MY STOMACH BEGAN HURTING , CONSTIPATION,  I HADE DIARRHEA FOR 3 DAYS , I WAS DIAGNOSED WITH PANCREATITIS AND THEN HOSPITALIZED FOR 3-5 DAYS.
After the vaccine I had 7 hours of chills. I had a bad headache and body aches for 2 days. I was not able to function after that. I was taking ibuprofen. Then I started feeling better. In May 2022 I tested positive for Covid. I had a high fever, body aches, headaches, lethargic, congestion, and a lot of coughing. I was prescribed PAXLOVID. I was in bed for 12 days and missed work. On June 10, 2022 I am going to the doctor because I have extreme vertigo. When I try to do physical activities, I feel a flutter in my chest. It feels like something is rattling and it makes me cough. I'm still having vertigo and feeling lethargic. I also still have this weird feeling in my chest.
Patient developed sore arm, inflammation the size of a golf ball per patient and redness. Instructed patient to note size and start a cool compress and some motrin. If symptoms worsened to f/u with urgent care or medical provider and take some benadryl. Contacted patient 1 hr laer to re assess and patient had not started cool compress yet. F/u with patient the next morning and she stated redness had resolved and swelling was diminishing. She was able to move arm and was doing much better. Instructed her to continue with cool compress a few times throughout the day and to contact us if it did not continue to improve.
3RD DOSE PFIZER COVID VACCINE GIVEN 12/7/21, LOT #FJ1620; pt had a positive COVID test on 7/30/22; brought to hospital and admitted to Hospice for end of life care; comfort measures; pt had previous aspiration pneumonia as well; acute hypoxic respiratory failure; pt passed away in the hospital under hospice care
I had two days fevers after second shot of moderna Covid vaccine, and after two days of the fever, then my chest pain like I had a pneumonia for another three days, then my right arm and my body especially my back starting breaking out like big rashes for two days, then my right head right are and right leg starting feels numbness, tingling, and hurting. I am sweating all the time now, when I am not a sweating person before I had the moderna Covid vaccine.
STROKE; This spontaneous report received from a consumer concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included epileptic seizures when seeing flashing lights, he had no prior history of stroke or any surgery, and concurrent conditions included high blood pressure, and type 2 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, administered, on 16-MAR-2021 around 10:30 in the morning for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 25-MAR-2021, the patient had stroke. The reporter did not know what kind of stroke the patient had. He was not found immediately when he had the stroke and when patient arrived at the hospital he was paralyzed on the left side and was put on the feeding tube and ventilator and moved to hospice after 8 days. On 09-APR-2021, the patient died from stroke. It was unknown if an autopsy was performed.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210428085-COVID-19 VACCINE AD26.COV2.S -Stroke. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.; Reported Cause(s) of Death: Stroke
No additional AEs; Improperly stored adverse event with GARDASIL 9,; This spontaneous report was received from an office manager  referring to a 13 year old patient (gender unspecified). There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-APR-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), dose:0.5 milliliter for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   The administered dose of the vaccine experienced a temperature excursion 35.2 degrees Fahrenheit for 480 hours/ 0 minutes, as recorded by a data logger. It was reported that the vaccines did not have previous temperature excursion. There was no adverse effect reported. No product quality complaint was involved.
Started out with irregular heart beat which slowly got worse. Then  heart palpitations and then heart pain
After receiving vaccine and being directed to waiting area for 30 min of observation, I felt lightheaded and dizziness within 5 minutes of sitting down. Nurses on site at vaccination facility provided me with apple juice and I felt better. I laid down on medical bed for remainder of the 30 minutes and was able to walk out of vaccination site on my own.
Prolonged pain at site of injection, limited range of motion about shoulder for > 2 weeks
Sore arm (beginning 4/12 at approximately 4:00 p.m. and lasting for approximately 24 hours) Headache (beginning 4/13 at approximately 11:00 a.m. and lasting for about 12 hours; treated effectively with Tylenol) Body ache/fatigue (beginning 4/13 at approximately 12:30 p.m. and lasting about 4 hours)
This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with, .5 ml RECOMBIVAX HB on 29-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced incorrect storage of drug. No treatment information was reported. The outcome of incorrect storage of drug is unknown. Incorrect storage of drug is not related to RECOMBIVAX HB. Patient was given RECOMBIVAX that was stored in a plastic syringe in the refrigerator. No AE reported. No further AE information is available. {Additional information has been requested.
Had shot and has had shingles./Suspected Vaccination failure; Shingles back to back; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shot and has had shingles./Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles back to back). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-MAR-2023 The case was received from the patient's son/daughter interactive digital media. The reporter's mother had the shot and has had shingles back to back, had last month and again now (at the time of reporting). This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This case is linked with US2023AMR064971, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR064971:Same reporter
October 05, 2021 was diagnosed with COVID and seen in the ER and released home. Sent home with pulse OX. Did not run fever and pulse ox didn't drop below 93.
Seven minutes after getting his vaccination coming he felt lightheaded. He had a brief episode of syncope lasting less than one minute. He was taken to a private area and monitored. Initial but pressure was 80s/50s with HR in the 50s. 20 minutes monitoring showed that his blood pressure and heart rate normalized.  CN II-XII intact and Neuro exam normal.
Systemic: Allergic: Rash Generalized-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Patient had hives all over body a day after administration of shot. She went to the ER and they gave her benadryl and steroids which only made her hives worse. She states she has had flu shots in the past with no issues. However the patient does have numerous other allergies - none of which were identified as being in the high dose flu shot.
Patient was given pediatric dose (age 5-11) instead of adult dose booster. She was given 0.3ml of Pediatric dose.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case contains information for the 5th of 40 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Pharmacy intern reporting that correctional facility administered 40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients. No patient information or product information available.   Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master
Pt received TDAP (BOOSTRIX) on 16 JUN 09 developed rash on 17 JUN 09 was evaluated by provider on 24 JUN 09 + Txed with ZANTAC + PREDNISONE.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown date, the patient were vaccinated with an improperly stored MMR II, lot number J013316, expiration date 22-JAN-2015 and lot number K004949, expiration date 04-APR-2016, (dose and route were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
PT COMPLAINED OF MALAISE, CHILLS, FATIGUE AND HEADACHE.  PT REPORTED SHE TOOK AN EXCEDRINE, WHICH GAVE HER SOME RELIEF FROM HER HEADACHE. PT ALSO RECEIVED A TB TEST ON THIS DAY.
Patient came in on June 30,2023 and received the three vaccines listed above. Patient started experiencing symptoms on July 01,2023. The symptoms displayed were fever in the area of vaccination (left thigh) and a red knot on the patients thigh which was sensitive to touch. Over the weekend the symptoms progressed. On July 03,2023 mother called to have the patient seen in the clinic. Patient was seen by PA where he diagnosed adverse effect of vaccine. Patient was prescribed Benadryl allergy liquid and Cefdinir. Mother was also educated on the vaccine reaction. Follow up was scheduled for July 06,2023.
Vaccination failure; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 64 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 02Apr2021 as dose 2, single (Lot number: ER8733), in left arm, on 02Oct2021 as dose 3 (booster), single (Lot number: FF2588), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FJ9943), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Peanut allergy" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Mar2023, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset Mar2023, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PF-07321332, ritonavir (PAXLOVID), from 03Mar2023 to 08Mar2023 as covid-19 treatment.
"Reaction to her injection at yesterday's office visit. Her arm is swollen 3x it's size and is red and hot."
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61-year-old male patient received BNT162b2 (BNT162B2), on 30Jun2021 at 15:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (Jul2022) Positive, notes: positive indication After 3 days. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Patient received treatment with Paxlovid from 19Jul2022 till 23Jul2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.