chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Exquisite local tenderness out of proportion to mild swelling and 3 coin-sized areas of erythema not directly associated with administration site.
The patient let us know that she had had a seizure after the first COVID shot and that she has them after every vaccine. This has happened since she was a little girl. The patient was visibly nervous before the vaccine was administered. During her observation time following the vaccine administration, she let provider know that she could feel her left arm tightening up. Provider provided the patient with an ice pack for her neck to try to calm her down. The patient asked for us to not call a rapid response yet and that "I'm trying to calm myself down." observed the patient's left hand starting to grasp and the patient became tearful so asked the patient if she was okay. The patient stated she was okay. Provider asked her to let her know if she felt like she was going to have a seizure.  About a minute later, the patient let provider know she felt one coming. Provider called the RRT as the clinic Team Lead, let the patient know she was going to recline her in the chair she had been vaccinated in. Seconds after the chair was reclined, the patient's eyes started to roll back in her head and her eyelids started to flutter. Within about 10 seconds, the patient was jerking up and down in the chair. The clinic staff ensured the patient was safe until the arrival of the RRT. As the RRT arrived, the patient's seizure ended. The patient became alert to talk to the team that arrived to the clinic. She refused being seen by the ED. The clinic staff agreed to monitor her vitals until she felt comfortable to leave. After around 30 minutes after the seizure, the patient was in good spirits and stated she would like to stand and see how she felt. The patient stood up and walked around for a moment before saying she was ready to leave. Provider checked the patient out, and she left the clinic.
allergic reaction; Broke out into a rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4434297-00 .  A 62-year-old female patient received BNT162b2 (BNT162B2), on 08Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose number: 2, Route of administration: Intramuscular), administration date: 11May2021, when the patient was 61-year-old, for COVID-19 vaccination, reaction(s): "Eczema aggravated", "Psoriasis", "Stress"; BNT162b2 (Dose number: 1, Route of administration: Intramuscular), administration date: 11Apr2021, when the patient was 61-year-old, for COVID-19 vaccination, reaction(s): "Eczema aggravated", "Psoriasis", "stress". The following information was reported: RASH (non-serious) with onset 2022, outcome "unknown", described as "Broke out into a rash"; HYPERSENSITIVITY (non-serious) with onset 2022, outcome "recovered" (2022), described as "allergic reaction".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2 month-old male was administered a Pentacel vaccine, but it was not reconstituted with the HIB portion of the vaccine with no adverse event.; Initial information regarding an unsolicited valid non-serious was received from other health professional via Medical Information (Reference number- 00537382) and transmitted to Sanofi on 26-Mar-2021.  This case involves a 2 months old male patient who was administered with a 0.5 mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], but it was not reconstituted with the HIB portion of the vaccine (lot UJ336AAA and expiry date: 05-Jul-2021) via intramuscular route at an unknown administration site for prophylactic vaccination on 23-Mar-2021.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  It was actual medication error due to Inappropriate reconstitution technique (on same day).  The reporter wanted to know if there was any other diluent that can be used on the Pentacel powder and inquire about ordering 0.4% (percent) sodium chloride solution. The error was discovered on the day of reporting. They reported that they will administer stand-alone ActHIB.  At the time of report, the patients experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt reported severe pain and swelling in upper right arm.  Reported immobility in right shoulder.  Went to orthopedic urgent care 2 days later.  States she received a steroid shot and pain meds.  States she will have out patient therapy.
Information has been received from a physician through medical records concerning a 1 day old, 3345 gram, white male who on 02-JUL-2008 was vaccinated with the first dose of RECOMBIVAX HB (manufacturer unknown).  There was no concomitant medication.  On 08-JUL-2008 the infant was seen for a routine visit.  He was noted to weigh 7 pounds and 4 ounces.  It was reported that the infant had mild jaundice and doesn't burp well, he has some spitting.  It was also noted that the infant had passed a newborn hearing screen on an unspecified date.  The child was reported to have appropriate growth and development.  On 27-AUG-2008 the child was seen for a routine visit.  His weight was reported to be 11 pounds, 8 ounces.  It was noted that the child had experienced a gagging and choking episode that started a couple of weeks prior, and had been taken once to the emergency room due to "choking on his spit."  No treatment or outcome information was provided.  It was also noted that the child spits up and is sometimes fussy.  At this visit, the infant was reported to have GE reflux and the formula was changed.  The infant was to be seen for follow-up in 2 months.  On 27-AUG-2008 the child was vaccinated with the first dose of ROTAVIRUS, by mouth; ACTHIB; PREVNAR; and PEDIARIX.  Additional information has been requested.
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In April 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). On 19-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  Vaccine was frozen at the time of the excursion. The temperatures were reported as Maximum 30 Fahrenheit Degrees and Minimum -18.9 Fahrenheit Degrees The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute Lot numbers were reported as 065K21A and 045L21A.   This case was linked to MOD-2022-591989 (Patient Link).
Additional information provided patient demographics, lot number, additional suspect vaccines, event details and laboratory data. Information regarding PREVNAR was received from a healthcare professional regarding a 12-month-old female who received PREVNAR that was administered orally and was fussy. The patient received a dose on 02-Mar-2009. Additional suspect vaccines included Dpt, Haemophilus Influenzae B, M-M-R II, Varicella Virus Vaccine, Live and Hepatitis B Vaccine. On 02-Mar-2009, the patient received PREVNAR that was administered orally. The patient's grandmother reported the child was fussy, but since she had received "5 other shots", they did not associate the fussiness with the PREVNAR. The outcome was unknown. On follow-up the physician noted that no adverse event had occurred. No additional information was available at the time of this report.
This spontaneous report as received from a registered nurse refers to a 21 year old patient of unknown gender. The nurse stated, that a 21 year old patient received his first dose of RECOMBIVAX HB (dose, units, route of administration, anatomical location, lot number was not reported) in 1994 (exact date unspecified). On 17-NOV-2014 (reported as today), the patient inadvertently received a pediatric formulation of RECOMBIVAX HB (second dose, strength reported as: 2.5 mcg/0.5 ml, route of administration, anatomical location, lot number was not reported). No adverse effects reported. Additional information has been requested.
After administration, patient had tingling in her left arm immediately and felt like her arm was "swelling immediately." After sitting down, her throat began to swell. She described it as "swallowing cotton balls", then "a large lump in her throat", then "narrowing of her throat so that it felt as if she was breathing through a closing straw." Patient was having an anaphylactic reaction to the vaccine. I (the pharmacist) administered an EpiPen once, then 50mg diphenhydramine IM, and called 911. Patient was evaluated by EMS and brought to the hospital for observation.
SERIES OF VAXS GIVEN: DOSE#1 12-19-89, DOSE #2 1-22-90, AND DOSE #3 2-24-90.ONE MO AFTER #3 RESULTS NEG.4TH BOOSTER OF ENGERIX-B GIVEN 3-30-90 ACHIEVED PROTECTION AGAINST HEP-B
Numbness and Paresthesia bilateral feet and shins; Numbness and Paresthesia bilateral feet and shins; right lower extremity weakness; cough; shortness of breath; chest tightness; confusion; This is a spontaneous report from a contactable physician reporting for a patient. A 46-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 13Apr2021 13:00 (Batch/Lot Number: EW0162) as SINGLE DOSE for covid-19 immunisation at 46 years old. Medical history included DJD cervical spine and Raynaud's Phenomenon from an unknown date. Concomitant medications included amlodipine taken for an unspecified indication, start and stop date were not reported. The patient experienced numbness and paresthesia bilateral feet and shins; right lower extremity weakness, cough, shortness of breath, chest tightness, confusion on 13Apr2021 13:15. Treatment included albuterol. The patient was hospitalized for the events on an unspecified date for 2 days. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab): negative on 16Apr2021 and 17Apr2021, and blood test (SARS-CoV-2 antibody test) negative on 16Apr2021.Outcome of the events was recovered with sequelae (Recovered with lasting effects) on an unspecified date in 2021.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment. Based on the available information and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the events cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Expired Vaccine (39 days post thawing in the refrigerator) administered to 50 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine (39 days post thawing in the refrigerator) administered to 50 patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine (39 days post thawing in the refrigerator) administered to 50 patients). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine (39 days post thawing in the refrigerator) administered to 50 patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were provided.
Few papular erythema type rash noted on face, back, legs and abdomen since yesterday.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), 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), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient had no other medical history. COVID-19 Treatment start date was 13Dec2022 and stop date was 17Dec2022 via oral route.Adverse event Covid rebound on 21Dec2022, 4 days post last Paxlovid dose with outcome Recovering, and no treatment received.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events drug ineffective, covid-19 and suspect drug BNT162B2 cannot be excluded.
This spontaneous report was received from a pharmacist and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or concurrent conditions were reported. the pharmacist reported that multiple unknown patients were vaccinated on multiple unknown dates with improperly stored PROQUAD (rHA) lot number M014304, expiration date 22-SEP-2017, lot number M014302, expiration date 22-SEP-2017 and lot number M007965, expiration date 15-AUG-2017, (dose, route and frequency not reported). No adverse effects were reported. the pharmacist reported that the temperature of the excursion was -14.4 C, and that the time frame was 12 hours and 15 minutes. There were no previous temperature excursions and the report was because of a data logger. No product quality complaint was reported. Lot numbers M014304, M014302, and M007965 have been verified to be valid lot numbers for PROQUAD (rHA). This is one of several reports from the same reporter. Additional information has been requested.
5/16/03 4 x 6 cm indurated and inflamed left deltoid at site of DTaP injection given on 5/14/03.
A non-serious spontaneous report of bloody nose has been received from a physician concerning a four to five year-old female, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST in September 2010 for an unknown indication. The patient developed a bloody nose immediately after receiving FLUMIST. No treatment was reported. The outcome for the reported adverse event was considered resolved.
PAIN IN CALF AND CHECKED CALF AND SAW A LONG DARK VEIN (DESCRIBED IT AS ONE LONG VEIN 80% OF HIS CALF); HEADACHES (DESCRIBED THEM AS HEAVINESS AND FULLNESS); DOUBLE VISION (COULD NOT READ SUBTITLES WHEN WATCHING A MOVIE); MENTALLY OFF CAN NOT PROCESS; FEELS WEIRD; COULD NOT DRIVE HOME; This spontaneous report received from a consumer concerned a 36 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: migraines, poison oak allergy, alcohol user, and smoker, and other pre-existing medical conditions included: The patient was very healthy. The patient have no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced double vision (could not read subtitles when watching a movie). On AUG-2021, the patient experienced mentally off can not process. On AUG-2021, the patient experienced feels weird. On AUG-2021, the patient experienced could not drive home. On AUG-2021, the patient experienced headaches (described them as heaviness and fullness). Treatment medications included: paracetamol. On 23-AUG-2021, the patient experienced pain in calf and checked calf and saw a long dark vein (described it as one long vein 80% of his calf). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headaches (described them as heaviness and fullness), and the outcome of double vision (could not read subtitles when watching a movie), mentally off can not process, feels weird, pain in calf and checked calf and saw a long dark vein (described it as one long vein 80% of his calf) and could not drive home was not reported. This report was non-serious.
Patient vaccinated today with expired Proquad dated 9/16/20. Merck notified- states based on the vaccine expiration date and todays date the stability of the vaccine is good. However, it is up to the provider to decide whether or not to re-vaccinate this patient. Case number. Dr.  informed of the above information and has chosen not to vaccinate the patient again.
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of GARDASIL, (dose number, lot/batch number, expiration date, route of administration not reported) that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.05 hours cumulatively through 07-MAY-2014. It was reported that also M-M-R II, PNEUMOVAX, ROTATEQ and PEDVAX were improperly stored (event captured in MARRS # 1405USA012894, 1406USA000956, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported. This is one of several reports from the same source. Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013 to March 2014. The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibration to the health department. All telephone attempts to obtain follow up information have been unsuccessful. Follow up information has been received from Registered Nurse on 27-JUN-2014.The nurse stated that one dose of GARDASIL (Lot #H021608, expiration date 13-AUG-2015, dose not reported) that was exposed to highest temperature of 9C for 6 hours from 28-AUG-2013 to June 2014 was administered to unspecified patient (unknown age and gender) on an unknown date. This is one of several reports from the same source. Additional information is not expected.
Pt recieved vaccination and departed after her observation period. She returned to the site shortly after reporting very mild facial swelling, rash to neck/chest, tingling and "a tickle in her throat." Initially she denied SOB, cough, tongue/airway swelling. HR 150/80, HR 87, SP0298%, RR: 16 unlabored. Small areas of erythema were appreciated to lateral neck and upper chest. No facial swelling, tongue/mouth swelling appreciated. No wheezing heard. Pt was given 50mg of Benadryl and 911 was called . At time of EMS transport, the pt developed a cough but vital signs remained WNL.
PROJECTILE VOMITING, SPINNING, LEFT SIDE TINGLING AND WEAK.