chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 05-JUL-2017 from a pharmacist who was reporting on a patient of unknown age and gender. No medical history or concomitant medications were reported. The pharmacist reported that on an unknown date, the patient was vaccinated with a dose of VARIVAX (lot and expiration were not reported) (dose and site not reported) vaccine received for prophylaxis was expired (date unknown) and sterile diluent (dose, lot and expiration not reported). The pharmacist reported that the vaccine had been expired by "one month". The pharmacist stated she had no additional information but would call back with lot number and expiration date. No adverse effects reported. Additional information has been requested.
dementia; This is a spontaneous report received from a contactable reporter(s) (Physician).  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 immunization. The following information was reported: DEMENTIA (disability, medically significant), outcome "not recovered". It was unknown if therapeutic measures were taken as a result of dementia.  Clinical course: the patient age was 65+ Years. Patient was moved to a long term care facility. Patient healthy before mentally and physically. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, it was unknwon if the patient was diagnosed with COVID-19. Since the vaccination, it was unknown if the patient has been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case narrative, a causal association between reported event dementia and suspect BNT162B2 cannot be excluded. Case will be reassessed once new information is available. 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.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 21-SEP-2017, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-SEP-2017, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included Diluent MRK inj. On 22-MAR-2018, the patient was vaccinated with expired dose of ZOSTAVAX (dose, units and frequency not reported) (lot # M041085 and expiration date: 03-JAN-2018) subcutaneously. No adverse effect reported. No product quality complaint was involved.
Pt's R leg red, swollen, warm to touch. Pt denies pain negative fever negative disability.
Vial was initially stored in the refrigerator on 8-Jul-2022 and was administered on 9-Aug-2022; No adverse event; Expired dose administered to patient 2 days after use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient 2 days after use by date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 8-Jul-2022 and was administered on 9-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient 2 days after use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 8-Jul-2022 and was administered on 9-Aug-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient 2 days after use by date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 8-Jul-2022 and was administered on 9-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient 2 days after use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 8-Jul-2022 and was administered on 9-Aug-2022).    No concomitant medications were reported. The patient had not reported any adverse reactions to this dose. The vial was initially stored in the refrigerator on 8-Jul-2022. No treatment medications were reported.
17 people were given vaccines during improperly stored; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 02-NOV-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S035125, expiration date: 04-NOV-2022, 0.5 milliliter (dosing schedule and route of administration were not reported) for prophylaxis. Administered dose of vaccine underwent temperature excursions: -13.9 Celsius (C) degrees to -14.7 Celsius (C) degrees in the following time frames: -14 C to -10 C (-13.9 C): for 30 minutes, -14 C to -10 C (-14.2 C) for 15 minutes; -14 C to -10 C (-14.7 C) for 20 minutes and -14 C to -10 C (14.6 C) for 5 minutes, as recorded by digital data logger.
24 hours post Pneumovax 23 injection, patient c/o discomfort in arm. Established scar near injection site was first to turn red. Over 12 hours on 8/24/14 and 8/25/14, patient c/o increasing pain/redness. Treated with Benadryl 25 mg PO (1 dose given 8/24/14 at 21:30 and 1 dose given 8/25/14 at 04:00).
She had complaints of severe h/a, fever 101.6, tender abdomen, chills, shaking all over. She was treated was treated with NSAIDs and rest.
Night of and night after experienced body muscle aches; 3 days after had fainting spell and vomitting
Received present complaint from Emergency Room Doctor requesting name of vaccines child received 2 hours in ER. Seizure this AM in school for 2 minutes. 01/24/07- received ER report supports seizure with recommendation to see a neurologist. Seizure at school. Seen in ER lethargic . PE: WNL.
pt recv vax 7OCT97 & broke out in flat round rash 12 or 13OCT97-itching;fever 14OCT97 102.7;father state pt had measles x 3 days & had elevated temp 105-108;around APR97 was seen @ hosp;
Sore throat; injection site pain; tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 27May2021 16:15 (Lot number: EP6955) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 28May2021 17:00, outcome "recovering", described as "Sore throat"; VACCINATION SITE PAIN (non-serious) with onset 28May2021 17:00, outcome "recovering", described as "injection site pain"; FATIGUE (non-serious) with onset 28May2021 17:00, outcome "recovering", described as "tiredness". The events "sore throat", "injection site pain" and "tiredness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of oropharyngeal pain, vaccination site pain, fatigue.  No follow-up attempts are possible. No further information is expected.
missing of scheduled second dose of vaccine / dose omission; stroke; right side of his body paralyzed, from his face to his feet; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and HEMIPLEGIA (right side of his body paralyzed, from his face to his feet) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke in October 2015.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant) and HEMIPLEGIA (right side of his body paralyzed, from his face to his feet) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missing of scheduled second dose of vaccine / dose omission). The patient was treated with Rehabilitation therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown, HEMIPLEGIA (right side of his body paralyzed, from his face to his feet) had not resolved and PRODUCT DOSE OMISSION ISSUE (missing of scheduled second dose of vaccine / dose omission) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       After hospitalization, patient was transferred to nursing home, then a rehabilitation facility. The second dose of the Moderna COVID-19 Vaccine was scheduled for an incorrect date of 04-Mar-2021;however the patient did not receive this dose due to hospitalization.  Products known to have been used by the patient, within two weeks prior to the event, included unspecified 15 pills. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
12JUN95 pt called & stated had a rxn to Tetanus shot recv 1JUN95; c/o swollen, hard red & itchy; 2" diameter, very drowsy
Pain in arm - no longer occurring  3 days after pain in left side of testicle, pain is getting worse - still occurring  Per poison specialist - Unknown if it is due to vaccine or not because it is not a usual/listed side-effect of the vaccine. Needs to get checked by PCP to run tests such as an ultrasound to check for any abnormalities and rule that out.
Patient was admitted to NICU, ICU for 24 hours observation; Flu vx adult given to baby; This case was reported by a other health professional via call center representative and described the occurrence of hospitalization in a infant patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   On 21st October 2021, the patient received Influenza vaccine Quadrivalent 2021-2022 season. On 21st October 2021, less than a day after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced hospitalization (serious criteria hospitalization) and inappropriate age at vaccine administration. On an unknown date, the outcome of the hospitalization and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the hospitalization to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Flu vaccine for the adults which led to inappropriate age at vaccine administration. The reporter was not quite sure of how old the patient was.  The reporter was unsure if this was Fluarix or Flulaval vaccine as it was not specified on the afterhours VM box. The patient was admitted to newborn intensive care unit, intensive care unit for 24 hours observation.  The reporter consented to follow up. Adverse event was received on afterhours VM box, attempted several times to contact healthcare professional at the specific phone number provided on the VM for specific Flu vaccine and to clarify the age of the patient.  No additional details were available.
From information received on 11/25/2002, it was reported by a 65 year old female patient that she was bitten by a bat on 07/20/2002.  She received post-exposure prophylaxis on 07/23/2002, was given IMOGAM USP HT & IMOVAX RABIES, and completed the series on 08/20/2002.  She now has aches in her arms and legs.  She also has numbness in her legs, which feels like pins and needles.  She has a red area across her nose and cheeks and her face often turns beet red.  PEP series was given at a medical center outpatient pharmacy.  It is not known whether the patient recovered.
The nurse accidently administered the diluent instead of mixing the diluent with the powder; Case reference number US-BN-2021-000033 is a spontaneous case report initially received from a parmacist via Agency (reference number USBAV21-0030) on 22-Jan-2021 and concerns a patient over 60 years-old.  The patient's medical history and concomitant medications details were not provided.  On 22-Jan-2021, the nurse accidently administered to the patient the diluent instead of mixing the diluent with the powder of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. ARBA731A) for post exposure (Product administration error).   It was stated that the reporter asked if there was anything they can use as the diluent to mix with the vaccine.  At the time of this report it was not known whether the patient experienced any adverse event.  No further information was provided.; Reporter's Comments: Product administration error is listed by convention. Reportedly, the nurse accidently administered to the patient the diluent instead of mixing the diluent with the powder of RabaVert which is considered to be product administration error. No adverse events were reported. Product administration error is not related to t RabaVert but to human action.; Sender's Comments: Product administration error is listed by convention. Reportedly, the nurse accidently administered to the patient the diluent instead of mixing the diluent with the powder of RabaVert which is considered to be product administration error. No adverse events were reported. Product administration error is not related to t RabaVert but to human action.
Received the Shingrix vaccination before she broke out with 1st round of Shingles; Always on eye; 1st round of shingles. Always on face; cheek, lower face,  jaw line. Above right eye and on chin; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)) and dermatologicals nos (Ointment). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingrix.     Additional information were received as follows: The age at vaccination was not reported. It was reported that the patient did received shingrix vaccination right before breakout with first round of shingles in late October 2021 or early November 2021.  The patient reported 2 more outbreaks since initially diagnosed by primary health care. The patient was prescribed antivirals by primary health care provider and ointment for around her eye by ophthalmologist since shingles were almost in her eyes. The patient reported 3 occurrences of shingles always on face, eyes, cheek and lower face and jaw line, above right eye and on chin under mouth. The reporter did not consented to follow up. This case was considered as suspected vaccination failure since details regarding completion of primary vaccination schedule and laboratory confirmation was not provided.
became N/V- Wanted to go to ED for treatment- given zofran ODT, symptoms resolved.
Started with leg pain Getting feeling like I am going to get a cramp Been feeling like this for almost a month
Vaccine was given at 3pm.  At 4:30pm patient had a tight chest so he used his inhaler.  At 8:30pm he went into anaphylaxis---red from head to toe, swollen hands and feet, could not move fingers or toes, lips blue and swollen. He was transported to the ER.
This spontaneous report as received from a Licensed Vocational Nurse regarding an unspecified patient of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 10-AUG-2015, the patients were vaccinated with 11 doses of improperly stored doses of VARIVAX (Merck) lot# L003774 and expiry date: 04-FEB-2016. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a Registered Nurse and refers to a unknown patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of VAQTA for prophylaxis (lot number reported as M002921, with an expiration date of 08-APR-2018 (strength, dose and frequency were not reported). No concomitant medications were provided. The doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit (F) to 35 degrees F for 228 hours and from 47 degrees F to 77 degrees F for 18 hours and 20 minutes. The aforementioned temperature was identified due to a data logger. There were no previous temperature excursions reported.  This is one of several reports received from the same reporter. Additional information has been requested. ; Sender's Comments:  US-009507513-1704USA003224: US-009507513-1704USA003228: US-009507513-1704USA003226: US-009507513-1704USA003014: US-009507513-1704USA003223: US-009507513-1704USA003225:
Blood in urine; Severe flu like symptoms; Severe stomach pain; Headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HAEMATURIA (Blood in urine), INFLUENZA LIKE ILLNESS (Severe flu like symptoms), ABDOMINAL PAIN UPPER (Severe stomach pain) and HEADACHE (Headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Severe flu like symptoms), ABDOMINAL PAIN UPPER (Severe stomach pain) and HEADACHE (Headache). On 04-Apr-2021, the patient experienced HAEMATURIA (Blood in urine). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 04-Apr-2021, INFLUENZA LIKE ILLNESS (Severe flu like symptoms), ABDOMINAL PAIN UPPER (Severe stomach pain) and HEADACHE (Headache) had resolved. At the time of the report, HAEMATURIA (Blood in urine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: F/U: Outcome of event
intense breast pain over two days. took painkillers and found it hard to sit or stand up. Mostly in left breast. unusual because I never get menstrual-related breast pain - only mild soreness. I talked to my obgyn and she suggested it was due to IUD (unusual since I've had it for four years) and/or caffeine intake.
Shot received at 4pm 3/12. Sore arm evening of shot, very tired next 2 days and sore arm. Only slight soreness in arm on 15th & 16th