chrisvoncsefalvay/vaers-outcomes huggingface dataset:
five minutes after receiving immunization pt reported flushing, lightheadedness, dizziness and mild nausea.  Pt's blood pressure was 135/65 and heartrate 65 bpm. Pt remained seated for 15 minutes before she said she felt well enough to stand up. Pt went home and pharmacist called pt 4 hours later. Pt reported feeling back to normal within one hour except for a mild headache.
Systemic: UNKNOWN, NO ADVERSE EVENT-Mild, Additional Details: THE PATIENT DO NOT FILL ANYTHING
3cm indurated area at site of MENACTRA injection. Patient came into our office on 8/2/11 and was seen by Dr. Was given ARISTOCORT cream & BENADRYL was given on 8/3/11 when swelling had increased to size of palm of father's hand. Was better by 8/4/11. Still some redness but no swelling on 8/10/11.
Headache, Myalgia, Fever & NauseaVomiting Narrative:  1/21/21: at 01:00: sudden onset of chills, body aches, nausea, headache, fever ,sweating, no appetite/little PO intake until 22:00 1/22/21: nausea, headache, fatigue, chills, no appetite/little PO intake 1/23, 1/24, 1/25: nausea, headache, fatigue
A patient received an expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from consumer/non-healthcare professional via Global Medical Information (GMI) (Reference number- 00710335) and transmitted to Sanofi on 04-Aug-2021.  This case involves a 11-year-old female patient received an expired MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE for prophylactic vaccination.  On 29-Jul-2021, the patient received a dose of expired suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6521AA and expiry date: 26-Jan-2021) via an unknown route in the right deltoid for prophylactic vaccination (expired product administered).  It was reported that "It was realized afterwards that the Menactra dose had expired on 26-Jan-2021. The pharmacist had incorrectly entered the expiry in the facility's electronic system as 21-Jan-2026, and that is why their system did not alert that the product should not have been used. The nurse stated that despite the pharmacist's error, the nurse who administered Menactra should have checked the label at the time, but that was not done and therefore the fact that the product was expired was overlooked prior to administration."  This was a case of actual medication error due to Expired vaccine used (latency same day).  At time of reporting, no adverse events were reported.  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 by the regulatory authority. 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.
Approximately 2 minutes after injection of JnJ vaccine patient fainted.... patient recovered after approximately 30 seconds
PROBLEM WITH BREATHING; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a parent concerned a female neonate. The patient was enrolled in a non-company sponsored study. The patient's weight was 3.91 kilograms, and height was not reported. No concurrent conditions were reported. The patient's parent's medical history Maternal medical history included hypothyroidism. The mother had body mass index (BMI) 30.692. The mother had no relevant obstetrical history and no history of tobacco, alcohol or recreational drug use. The estimated delivery date (EDD) was reported to be 29-NOV-2021. Type of pregnancy was reported as singleton. On 12-APR-2021, at gestational age seven weeks, the patient's mother received the vaccine. at gestational age 40 weeks, the mother delivered vaginally a live, full-term, female. The mother spent two days in the hospital for the delivery. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included levothyroxine and prenatal vitamins.  On 12-APR-2021, the patient experienced fetal exposure during pregnancy. On an unspecified date, the patient experienced problem with breathing (neonatal dyspnea) and was hospitalized in the Intensive Care Unit (NICU) due to problems with breathing (date unspecified). Number of days of hospitalization was not reported. The date of the patient's last menstrual period was 22-FEB-2021.  On NOV-2021, Laboratory data included: Acoustic stimulation tests (NR: not provided) baby passed the hearing test, and Cardiac function test (NR: not provided) baby's heart is fine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the problem with breathing and fetal exposure during pregnancy was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and problem with breathing was related, and between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20210944596.; Sender's Comments: V0: 20220117123-covid-19 vaccine ad26.cov2.s-problem with breathing. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20220117123-covid-19 vaccine ad26.cov2.s-fetal exposure during pregnancy. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS.
Initial information received on 13-Jun-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves nine patients (age and gender not reported) who were vaccinated with a dose of DAPTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was reported that 9 adults were vaccinated with wrong vaccine. No adverse event was reported. 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 and Module VI of the 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. Documents held by sender: none.
Patient almost immediately began to feel bad, muscle aches, fever. The response worsened within days and she saw a Doctor and ultimately was told she had pericarditis, decrease metabolism issues, triggered auto-immune response, developed Graves disease, decreased IGG levels, signs of decreased kidney function
Itching all over body, swollen painful joints, swollen hands and feet.  Large amount of Hair Loss.  Increased blood sugar.
Extreme pain in arm where injected. Chills. Pain is still in existence after 4 months.
Pt. arm got red & swollen.  Notice on 4/11/08 quarter size.
A non-serious spontaneous report of H1N1 inadvertently administered to 6 month old infant was received from a registered nurse concerning a six-month-old male. H1N1, Intranasal was administered on 12-Nov-2009. The patient did not have any past medical history or concomitant medications. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments were not applicable and the event was considered resolved. Additional information received on 16-Nov-2009 and incorporated in narrative: medical history and concomitant medications.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. On unknown dates in 2014, doses of ROTATEQ (lot # K001198 with expiry date: 25-OCT-2015, number of doses unspecified) that were improperly stored were administered to the patients. Reported excursion occurred in 2014 but it was not discovered until recent audit of temperature log in August 2016. The reporter confirmed administration of improperly stored vaccine doses. No adverse effects reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
A non-serious spontaneous report of administration of FLUMIST to a 17-year old pregnant female was received from a nurse practitioner concerning a 17-year old female patient. The patient received a single dose of FLUMIST on 22-Oct-2008. The reporter's clinic was not aware of the pregnancy until 18-Nov-2008. There was no adverse event associated with this pregnancy. Treatment and reporter/sponsor causality assessments are not applicable.
Patient was near syncope , clammy to touch, sweaty and nausea. Patient was given some water to drink. I took vitals at 9:05 am heart rate 59, o2 99 and BP 116/67. Patient was observed and asked how she was feeling and she stated that she was feeling better. I then had her sit up to see how she was feeling sitting up. I asked her how she was feeling and she stated that she was back to her normal self. I released the patient home with her husband. She was released at 9:12 am.
Began with Tinnitus and ended with significant hearing loss. Had CT and MRI with multiple hearing tests. Initial treatment was oral steroids for 2 weeks then steroid injections directly into the ear drum.  Was informed by Dr (ENT) that the nerve damage was permanent. The hearing loss is significant.
This spontaneous report was received from a registered pharmacist refers to a patient of unknown age who two weeks ago, on approximately 24-AUG-2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient's physician wanted to put him on prednisone therapy starting at 20 mg daily for three days, and tapering down. No adverse event reported for ZOSTAVAX but unspecified why prednisone was needed. At the time of the report, the patient's outcome was unknown. The relatedness for patient was prescribed prednisone for three days for unspecified reason was unknown for ZOSTAVAX. Additional information is not expected.
discomfort in his arm; like a little bit of hydraulic pressure from injecting fluid into tissue; he did consider general muscle pain in his shoulders as a source for the discomfort in his arm; he did consider general muscle pain in his shoulders as a source for the discomfort in his arm; Fatigued; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EW0176, Expiry date: Unknown), via an unspecified route in the left arm on 29Apr2021, as a single dose for covid-19 immunization. Medical history included diagnosed with high blood pressure probably 3 years ago, ongoing and had two hip replacements, one in Sep2019 and one in Sep2020, ongoing. Concomitant medication included began taking lisinopril a couple of years ago for high blood pressure, periodically takes ibuprofen or naproxen for aches and pains, he's had 2 hip replacements, and it's not the hip itself because it's synthetic, but the muscles around them every once in a while, get a little sore, so sometimes he has to take them more regularly, like lately they've had incredible weather that's been very rainy. Patient mentioned that he is still pretty active, very active for 71 years old, and working. On 29Apr2021, patient experienced some discomfort in his arm like a little bit of hydraulic pressure from injecting fluid into tissue, that went away in a day or two and fatigued. He did consider general muscle pain in his shoulders as a source for the discomfort in his arm. The clinical outcome of some discomfort in his arm like a little bit of hydraulic pressure from injecting fluid into tissue was recovered, muscle pain in his shoulders was unknown and fatigued was recovered on 30Apr2021.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse practitioner concerning a 44 year old female who was supposed to receive ADACEL on 25-NOV-2008 was accidentally vaccinated with a dose of GARDASIL (lot # 659184/0843X).  The patient was also outside the recommended age for the vaccine.  Unspecified medical attention was sought.  Additional information has been requested. This is in following to report previously submitted on 12/12/2008 : 1/7/2009. Information has been received from a nurcse practioner (N.P.) concerning a 44 year old female who was supposed to receive ADACEL on 25-NOV-2008 was accidentally vaccinated with a dose GARDASIL (lot# 659184/063X). The patient was also outside the recommended age for the vaccine. Unspecified medical attention was sought. Follow up information was received from a person at the the providers center who reported that she was the one who inadvertently administered the wrong vaccine to the patient. She reported that it was a case of human error) she simpley grabbed the wrong vaccine. She said that the patient had no side effects to report. Follow-up information has been received from a nurse practioner concerning a 44 year old female in sales who on the morning of 25-NOV-2008 was accidentally vaccinated in the right arm with the first dose of GARDASIL (lot# 659164/0643X). As of the report date, there was still no adverse event. No further information is avaliable.
Information has been received from a physician concerning a female patient who was vaccinated with her first dose of GARDASIL, IM. One week post vaccination, the patient experienced irregular menstrual period (two to three weeks earlier than schedule). Subsequently, the patient recovered from irregular menstrual period. Medical attention was sought. Patient Quality Complaints (PQC) was not involved.
Positive for COVID by PCR on 12/27/21. Pt had a slight cough at time of testing. Pt was admitted to the hospital for a mechanical injury.
tested positive between doses 1 and 2 of the vaccine; tested positive between doses 1 and 2 of the vaccine; This is a spontaneous report from a contactable pharmacist.  This pharmacist reported similar events for 6 patients. This is the 6th of 6 reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The pharmacist reported that 6 patients tested positive between doses 1 and 2 of the vaccine, in which the pharmacist was giving Covid vaccinations in a nursing home. It was reported that the patient was tested positive between doses 1 and 2 of the vaccine, in which the patient was hospitalized and had received antibodies. And had tested negative upon and continuously since returning to the nursing home. Those patients were tested every day. The pharmacist started administering the second doses. One patient was administered the second dose and then somebody said, "Oh, they were given antibodies in the hospital''. A fellow pharmacist in which they said, we're under the impression you wait 90 days if they've been given antibodies after that to give the second dose. One of the patients inadvertently received a second dose, not knowing that they received antibody therapy prior to administering the vaccine. The rest who were hospitalized did not receive their second injection. Caller asked, "What is the policy on antibodies and the second dose? When is the earliest date they can administer that second dose? The individual who was given it inadvertently, should they be given a third injection? Do you give them shot number two or do you start over and give them both shots?'' The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported testing with a positive viral load based on the known safety profile. ,Linked Report(s) : US-PFIZER INC-2021199894 same drug/reporter/event, different patient;US-PFIZER INC-2021222955 same drug/reporter/event, different patient;US-PFIZER INC-2021222956 same drug/reporter/event, different patient;US-PFIZER INC-2021222953 same drug/reporter/event, different patient;US-PFIZER INC-2021222954 same drug/reporter/event, different patient
Bumps on forehead.  Noticed bumps on scalp day after flu shot.  10/25/2014 went to Urgent Care and diagnosed with shingles.
69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.  Reporter stated that between 06-Jan-2022 and 11-Jan-2022, there were a total of 69 administered doses of Lot 012H21B. Of these, 68 doses were boosters and 1 dose was a first dose. On 06-Dec-2021, reporter placed Lot 012H21B vials in their refrigerator.
Patient was administered dose form a vial punctured more than 12hs before; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered dose form a vial punctured more than 12hs before) 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 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered dose form a vial punctured more than 12hs before). On 21-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered dose form a vial punctured more than 12hs before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter had stated that the vial was opened on 16 SEP 2021 and was administered on 21 Sep 2021, which was 5 days past the limit and was given to 2 patients.  Concomitant product use was not provided by the reporter. Treatment medication use was not provided by the reporter.
All flu symptoms, vomiting, diarrhea, sore and bruised arm. It lasted about 4 days. I had to call out sick for work. Also, fever, weight loss, headaches.
Delayed menstrual period, 2 months post vaccination without a menstrual cycle since (normally a 21 day cycle)
Covid19 breakthrough.  1st Vaccine received on 04/13/2021.  68 y/o with PMHx of HTN, Kidney stones, back pain, cysto, arthritis arrived to ED by EMS for 1 week history of progressive SOB.  EMS placed pt on 15L NRB due to hypoxia. Pt being held in ED waiting for inpatient bed.  Started on IV steroids/IV Abx and Remdesivir.  ID seeing pt.
02/19/2021  I had fever 101-104 for 2 days, vomiting, horrible headache, unbelievable joint muscle pain, vomiting, weakness and dizziness, diarrhea, chills and sweating, chest pain, trouble breathing
3 hrs p/vax, pt woke from nap & had unconsolable crying for more than 1 hr; felt warm to touch; seen by MD who advised no further pertussis vax;
Pt had a hard lump at injection site as well as in left elbow. Pt also had a warm rash on her entire upper arm. The rash is itchy. Rash is moving down her arm.
Patient in office for 6 month wcc received multiple vaccines, patient was crying consistently mom walked to waiting room about 15-20 minutes later checked on mom in waiting room and she said she think baby was breaking out on forehead, I then looked at patients forehead and noticed red spots on forehead and her eyelids were red, brought patient back in the room Dr examined patient and intervention took place, and Dr determined it was a possible vaccine reaction. Patient given bendryl and pulse ox was checked which was good, checked back on patient 10 mins later and mom said she was doing better and rash was going away, checked pulse ox and again and checked back on patient 10 min later and mom said she was back to normal and checked patient and rash was almost completely gone. Dr went back in room to check on patient and instructions given to mom.
Patient came in for his first pediatric COVID-19 vaccine, which we gave to him. Later, it was discovered an insufficient amount of diluent was added to the vial (making the dose more concentrated than intended). We contacted the manufacturer, reached-out to the parent to check on his well-being and explained the incident. Patient's mom said he was doing fine and had no adverse reactions from this vaccine.
Breakthrough case after 4 vaccines Pfizer 3/11/21 lot# EN6200;  Pfizer 4/1/21 lot# EW0150;  Pfizer 11/26/21 lot# FH8030;  MOderna 12/18/22 lot# 041H22A
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 75-year-old, elderly patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805411 was crossed linked to original cases 201804863 due to same reporter.
SKIN LESIONS ALL OVER THE BODY WITH ITCHING.  NO OTHER SYMPTOMS.  ERYTHEMATOUS MACULAR, PAPULAR AND PUSTULAR LESIONS ALL OVER THE TRUNK.