chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 16 year old female consumer with no drug reactions/allergies and a history of asthma, for GARDASIL, a Pregnancy Registry product. It was reported that on 03-JUL-2009 the patient was vaccinated with the first dose of series of GARDASIL. There was no concomitant medication. The patient reported that at the end of July 2009 she found out she was pregnant. The consumer reported that on 04-Aug-2009 she had terminated the pregnancy and had recovered. The consumer reported that she had not received any additional doses of GARDASIL. No adverse event was involved. It was reported that therapy with GARDASIL was discontinued and that the patient recovered on an unspecified date while on therapy. Therapy with GARDASIL was not reintroduced. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. Upon internal review abortion induced was considered to be an other important medical event. Additional information has been requested.
ITCHING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced itching. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from itching on 09-APR-2021. This report was non-serious.
chills started about6 1/2 hrs after shot extremely sleep about 8-9 hr after over all body aches started same time as chills all last right at 24 hrs
I stopped having periods, had very erratic periods and they were normal before, got pregnant a few months later, miscarried around 8 weeks, my periods have not recovered and I will be having to start hormone therapy at 42. Also did not protect me from COVID-19, I contracted COVID-19 in July 2021 and was hospitalized.
4/14/2020 - MMR, Varicella, Hep A vaccines given 4/15/2020 - red rash at injection site, low fever 99.8, diarrhea, tylenol and motrin given to reduce fever 4/16/2020-4/19/2020 - continuing fever between 99.9-100.8, diarrhea, tylenol and motrin given to reduce fever 4/19/2020 - red rash covering torso, arms, legs, diarrhea 4/20/2020-4/21/2020 - red rash covering body develops into full body hives and fever of 102. diarrhea, Benadryl given to reduce rash and hives 4/22/2020 - hives gone, but still a lingering minor body rash, eczema spots, fever 103.3 4/23/2020 - low grad fever 99, lingering minor body rash, eczema spots  4/24/2020 - diarrhea, fever gone, lingering minor body rash, eczema spots 4/25/2020-current - continuous lingering minor body rash, eczema spots
Resident had received booster dose 11/17/21, this dose was given making it a 4 dose in series.  No adverse reactions noted
expired acthib that was administered to a patient of 69 years old yesterday with no reported adverse event; expired acthib that was administered to a patient of 69 years old yesterday with no reported adverse event; Initial information received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 69 years old female patient who was administered expired HIB (PRP/T) VACCINE [ACT-HIB] yesterday with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Nov-2023, the patient of 69 years old was administered 0.5 mL dose of expired HIB (PRP/T) VACCINE [ACT-HIB] yesterday with no reported adverse event (expired product administered) and (product administered to patient of inappropriate age) (Powder and solvent for solution for injection) (Frequency = once) (Strength = Standard) (latency: same day) (lot UJ803AA and expiry date: 13-Aug-2023) via intramuscular route in unknown administration site for pre-operative immunization (Immunization).  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 the 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.
Case number PHHY2011AR51518 is an initial spontaneous report received from health authority on 07 Jun 2011. This report refers to a 41-year-old female patient. She was vaccinated with FLUVIRIN (batch number unknown) on an unspecified date. One day after vaccination, she experienced interstitial pneumonitis and was hospitalized on an unspecified date. She received antibiotics and anti-influenza treatment. Outcome and causality were not reported.
Products were out of range for a cumulative 2 hours, including high and low excursions with no adverse events; FLUZONE QUADRIVALENT NP was administered to a 60 year-old female post-excursion with no adverse event; Initial information receivedon 01-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves products diphtheria toxoid, poliomyelitis vaccine (inactivated), diphtheria and tetanus toxoids, meningococcal A-C-Y-W135 (D CONJ) vaccine [menactra], HIB (PRP/T) vaccine [act-hib] and influenza quadrival A-B vaccine [fluzone quadrivalent] that were out of range for a cumulative 2 hours, including high and low excursions with no adverse events and out of which fluzone quadrivalent np was administered to a 60 year-old female post-excursion with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE B (MENB) for Immunisation.  On 23-Jan-2023, the patient received a 0.5 dose of suspect influenza quadrival A-B vaccine (lot UP7683JA, expiry date- 30-Jun-2023 with unknown strength and form) via intramuscular route in unknown administration site as prophylactic vaccination.  On an unknown date the products diphtheria toxoid, poliomyelitis vaccine (inactivated), diphtheria and tetanus toxoids, meningococcal A-C-Y-W135 (D CONJ) vaccine [menactra], HIB (PRP/T) vaccine [act-hib] and influenza quadrival A-B vaccine [fluzone quadrivalent] that were out of range for a cumulative 2 hours, including high and low excursions with no adverse events (product storage error) (unknown latency) and out of which on 23-Jan-2023 fluzone quadrivalent np was administered to a 60 year-old female post-excursion with no adverse event  (poor quality product administered) (latency- same day).  It was reported that "Products were exposed to a high of 47.4 and a low of 31.4. Nurse states that in the process of trying to get the refrigerator temperature to a stable, in-range level, both high and low temperature excursions occurred. Nurse states that on or before 23jan2023, the refrigerator temperature was getting too warm, the maximum temperature reached was 47.4F. Staff adjusted the thermostat and put "a couple more bottles of water" into the unit. Then, on 26jan2023, the refrigerator temperature became too cold, the temperature went down to 31.4F"  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.    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 the 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.
Dizziness and light headed. Monitored patient for a few hours no meds given until recovery.
This case was reported by a consumer and described the occurrence of adverse reaction to vaccine in a female subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date, the subject received unspecified dose of FLUARIX (unknown route and injection site). At an unspecified time after vaccination with FLUARIX, the subject experienced adverse reaction to vaccine. At the time of reporting, the outcome of the event was unspecified.
Mother reported that child has hard swelling of right deltoid that extends into axillary area. Mother denies any other symptoms. Advised mother to contact child's pediatrician Dr. for consultation.
Pt developed bumps which then developed into vesicular lesions on the body. Pt presented to the office the 2nd day of the breakout.
Physician suggested to wait for second dose, she did not receive second dose; chills; fever; muscle pain, aches; Joint pain; fatigue; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Physician suggested to wait for second dose, she did not receive second dose), CHILLS (chills), PYREXIA (fever), MYALGIA (muscle pain, aches) and ARTHRALGIA (Joint pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced CHILLS (chills), PYREXIA (fever), MYALGIA (muscle pain, aches), ARTHRALGIA (Joint pain), FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (headache). On an unknown date, the patient experienced OFF LABEL USE (Physician suggested to wait for second dose, she did not receive second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, OFF LABEL USE (Physician suggested to wait for second dose, she did not receive second dose) outcome was unknown, CHILLS (chills), PYREXIA (fever), ARTHRALGIA (Joint pain), FATIGUE (fatigue), NAUSEA (nausea) and HEADACHE (headache) was resolving and MYALGIA (muscle pain, aches) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication did not help. The patient felt like she was hit by a truck. As of 21-Mar-2021, the patient woke up in the morning feeling better but she still has aches.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Lot number and event information updated
pt recvd vax;day p/ vax,became weak & sluggish;about 1 1/2 wk p/vax,lost hearing rt ear accompanied by pain;now main problem is hearing loss of rt ear;
After the shot was administered the store had me wait in case there was a reaction. While I was sitting down, waiting for about 15 minutes I felt dizzy and fainted. My head hit the floor. The store called the paramedics. I woke up sweating and the paramedics arrived. The paramedics took my bloodpressure and reported it at 84 over 50. They waited while I felt ready to stand up. After a 3 to 4 minutes I felt I could stand up and they took me outside. Once outside they took my blood pressure again and it was at 110/80. I opted to go home instead of the hospital and I feel tired.
menactra was mixed wrong , it is a powder substance that was accidently mixed with saline solution with no reported adverse event; Initial information received on 13-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 16 years old male patient for whom meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] was mixed wrong, it is a powder substance that was accidently mixed with saline solution with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE (INFLUENZA) for Immunisation.  On 12-Oct-2022, the patient received suspect meningococcal A-C-Y-W135 (D CONJ) vaccine at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination(immunisation).  On 12-Oct-2022 the menactra was mixed wrong, it is a powder substance that was accidently mixed with saline solution with no reported adverse event (product preparation error, latency: same day). Caller wanted to find out if it was safe to give menactra to her son again right away, or do they need to wait 4 weeks  Action taken: Not applicable.  Outcome: Unknown.   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 the guidelines. 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.
Positive for COVID-19; Little bit tired; This is a spontaneous report received from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown, NDC number: Unknown, UPC number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 08Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, when probed for the concern, consumer stated, "patient took it and positive for COVID-19 on this last Friday (on an unspecified date in Apr2021), isolation this coming Saturday and I had my first dose of the Pfizer vaccine on 08Apr2021, so I am made schedule on "06May2021" (not clarified) which was about two weeks after my symptoms would be gone and my isolation would be over, so patient just want to make sure to the vaccine the second dose of soon after patient had or something in the vaccine, so should patient take second vaccine soon after the virus or not. Patient was a little bit tired on an unspecified date in Apr2021." In response to further probing, consumer stated, "I don't think so actually it was fine." When probed for vaccine Lot number and expiration date, consumer stated, "Like the dose confirmation #7G613IX2Y2IEM2." The patient underwent lab test and procedure which included COVID-19: Positive on an unspecified date in Apr2021. The outcome of the events was unknown.  No Follow-up attempts are needed; Information about lot/batch number cannot be obtained.
2nd shot given high in the shoulder (higher than any vaccine I've received. A couple weeks following the shot I awoke at night with extreme pain at what seemed the shot site after which I gradually lost the ability to move my arm/shoulder without extreme pin and couldn't move it - diagnosed in April 2021 with adhesive capsulitis initially - pain radiates to hand and arm. In August 2021, right shoulder began to experience symptoms. I saw a doctor 10/07/2021, he recommended I have a referral to a rheumatologist because he believes the radiating pain might be systemic. Oct 14, 2021 I saw an article about Parsonage Turner syndrome and the Moderna vaccine. I have 11/15/2021 appointment with a rheumatologist.
This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 02-JUL-2015 the patient was inadvertently administered with improperly stored, MMR II, lot # K007107 (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a health professional concerning a 13 year old male who on 12-JUN-1997 was vaccinated with the first dose of varicella virus vaccine live (Oka/Merck). On 31-OCT-2007, the patient experienced approximately 50 lesions. Unknown medical attention was sought. On 13-NOV-2007, the patient recovered from lesions. No product complaint was involved. Additional information has been requested.
pt recvd vax; swelling , erythema to site lt deltoid 2 days p/ vax; fever of 100; dph given & apap for 5 days
This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Residual Patches Psoriasis) and INJECTION SITE PRURITUS (Felt itchy after injection area) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis. There were no reported medical history. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in prefilled pen, dose- CF. On an unknown date, the patient experienced PSORIASIS (Residual Patches Psoriasis) and INJECTION SITE PRURITUS (Felt itchy after injection area). At the time of the report, PSORIASIS (Residual Patches Psoriasis) had not resolved and INJECTION SITE PRURITUS (Felt itchy after injection area) had resolved. Not Provided. It was unknown whether the patient was enrolled in a COVID-19 Vaccine trail. No concomitant medications were reported. The primary reporter did not have the lot number information because the packaging was discarded. No treatment medications were reported for the events. The reporter considered that there was a causal relation between events of residual patches psoriasis and felt itchy after injection area and co-suspect Humira.
Onset about seven and a half hours after vaccinations given with swelling right leg and discomfort.  Rash at site and radiating to knee.  Has not seen doctor yet, plans to set an appointment this date.  Denied other complaints.  Mother reported swelling two times size at worst.  5/26/02 Discomfort less upper thigh, still continues below knee.  Two days later, leg was fine.
This spontaneous report was received from a licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of adult and pediatric RECOMBIVAX HB for prophylaxis, (dose, route, lot# and expiration dates were not reported). No adverse effects were reported. There were no previous temperature excursions; the data logger reported: "traceable Min. and Max." There was no Product Quality Complain (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA012322: US-009507513-1612USA013205: US-009507513-1612USA013206: US-009507513-1612USA013207:
Diagnosed with c-diff; Feeling dizzy; A spontaneous report was received from a consumer concerning a 80-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and diagnosed with c-diff(Clostridium difficile infection) and feeling dizzy.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 29 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced feeling dizzy. On an unknown date, the patient was diagnosed with c-diff(Clostridium difficile infection) and considered medically significant event.  No treatment information was provided for the event feeling dizzy.Treatment for the event c-diff(Clostridium difficile infection) included high dose of antibiotic.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events c-diff (Clostridium difficile infection) and feeling dizzy was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
osteoarthritis exacerbated; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (osteoarthritis exacerbated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis.    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 OSTEOARTHRITIS (osteoarthritis exacerbated). At the time of the report, OSTEOARTHRITIS (osteoarthritis exacerbated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported. No lab data provided by the reporter . Reporter also stated they know two people  who were old and in their 90s already vaccinated and had bad rheumatoid arthritis .
Patient experienced respiratory distress and unable to speak at about 12 PM on 10/14/17. Ambulance called. Patient treated at Hospital. Kept overnight.
after a while his penis shrunk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PENIS DISORDER (non-serious), outcome "unknown", described as "after a while his penis shrunk".  Additional information: reporter stated that he is calling for someone else that is really upset and bashful, stating that it seems his penis has shrunk. Consumer stated that he did not want to share any information or and do not contact again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
24 hours after receiving the vaccine, my daughter experienced chest pain. Per the recommendation of her doctor, we took her to the ER. She had a rash on her back and chest. After 48 hours, a low-grade fever of 101 (lasted 1 day) and a swollen lymph node on her right armpit.
Chest pain lasted 50 minutes. Patient went to local hospital emergency department and was evaluated with history, physical exam, EKG and blood tests. All were normal. Pain resolved without treatment.
Approximately 4 minutes after receiving vaccines, client told Mom she felt dizzy.  Before anyone could reach client she passed out and fell forward out of chair striking head on floor.
Pulse rate during exercise on elliptical used to be 148 to 152 bpm. Now my pulse rate is lower between 128 to 132 bpm. I get tired quicker during the day.