chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax 20JUL95 & w/in 24-48hrs following vax exp itching, diarrhea, darker urine, & was jaundiced when examined; pt was found to have elevated liver enzymes 01AUG95;MD demonstrated evidence of bile duct obstruction-bile duct stricture
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Batch/Lot number: unknown) and on 18May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Jul2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Negative; (11Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received COVID 19 treatment with oral paxlovid from 30Jun2022 till 05Jul2022. No other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Injection site soreness; Flu-like symptoms; achy from head to toe/sore; Redness; Swelling; Tired; did not feel well; lump under the armpit; This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date 11th September 2021) for prophylaxis.   On 18th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, less than a week after receiving Shingrix, the patient experienced axillary lump. On 19th May 2019, the patient experienced influenza-like symptoms, generalized aching, injection site erythema, injection site swelling, tiredness and feeling unwell. On an unknown date, the patient experienced injection site pain. On an unknown date, the outcome of the influenza-like symptoms, injection site erythema, injection site swelling, feeling unwell, axillary lump and injection site pain were recovered/resolved and the outcome of the generalized aching and tiredness were unknown.   It was unknown if the reporter considered the influenza-like symptoms, generalized aching, injection site erythema, injection site swelling, tiredness, feeling unwell, axillary lump and injection site pain to be related to Shingrix.  Additional details were provided as follows: The reporter had a consumer that received Shingrix in the left deltoid and was in bed all day because she did not feel good. The patient had significant redness and swelling at the injection site and  a lump under the armpit of the arm that received the vaccine.  Also, the patient had flu-like symptoms and she felt achy from head to toe. The patient started having flu like symptoms, redness and swelling in the injection site, fatigue, body ache the next day. On 21st May 2019, Tuesday, the patient came into the pharmacy and indicated that all symptoms had resolved except the injection site was still red and the lump was still present under the armpit, and she still felt tired. The reporter unable to obtain additional details because the consumer was not in the pharmacy at the time of the call. The case did not include any product complaint. There was a discrepancy with respect to the patient's initials.
Had I expected LAD heart attack on 15Feb after cardiologist said that heart is clear and risk is low; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Right on 12Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 72 years old. Medical history included diabetes mellitus, high blood pressure, hypothyroidism, and Known allergy: Sulfa from an unknown date and unknown if ongoing. Patient did not have COVID prior vaccination. Patient is not pregnant. Concomitant medication included metformin; metoprolol; amlodipine besilate (AMLOD); insulin degludec (TRESIBA); and clonidine hydrochloride (CLONIDIN) taken for an unspecified indication, start and stop date were not reported (other medications in two weeks). The patient experienced "had i expected lad heart attack on 15feb after cardiologist said that heart is clear and risk is low" on 15Feb2021 05:00.  The patient was hospitalized due to the event for 7 days on an unspecified date in 2021. The event required emergency room visit and physician office visit. Treatment was given for the event which includes Emergency Stent placement and update to medication. The patient underwent lab tests and procedures which included sars-cov-2 test (blood test): negative on 15Feb2021. Therapeutic measures were taken as a result of had i expected lad heart attack on 15feb after cardiologist said that heart is clear and risk is low (myocardial infarction). Outcome of the event was recovered with sequelae on 2021. Seriousness criteria was reported as hospitalization, medically significant, and life threatening.  Information on lot number/batch number has been requested.
Patient passed away on February 5, 2021. There was no reaction after the shot was given, the patient's son said the death was not related to the vaccine. The patient had a bad case of shingles about a month prior to receiving the vaccine which the son said had been hard on the patient, the patient was also 90 years old.  Per the son, the patient's doctor had wanted the patient to get the vaccine.  Due to the close proximity of the date the vaccine was given and the date Patient passed away we wanted to complete the VAERS form.
No additional AE; Patient was administered expired GARDASIL 9; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.    On 04-AUG-2021, the patient was administered expired hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R028387, expiration date 27-JUL-2021; strength, dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No temperature excursion reported for the expired/administered hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No additional adverse event (AE) (no adverse event). No product quality complaint (PQC) was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R028387; expirationdate: 27-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Sudden development of dyskinesia, chorea, involuntary abnormal movements approximately 3 weeks after vaccine administration. No altered mental status. Patient had similar presentation in 2011-2013 that was found to be associated with Embrel (resolved thereafter after switching to rituximab). Patient had not received Rituximab infusion since 1/27/21 and 2/10/21. So, it is unclear if Janssen vaccine was associated with event. Patient also resumed her Eliquis and Metoprolol 1 week prior to her symptoms starting.
Woke up on second morning after injection to a rash on upper chest going down to stomach area and on upper back and neck. No other symptoms.
Patient was administered their 2nd dose of Moderna from a vial that had been in the refrigerator for 31 days.  Vial did not undergo any temp excursions but was technically expired since it was past day 30 of refrigeration.  I called Moderna today, 7/25/21 to inquire about next steps.  Per current information available, I was informed that there is no recommendation in terms of whether or not to administer another dose, it is based on healthcare provider judgement. More than 2 doses have not been studied at this time.  We will reach out to pt's MD to get their opinion as well.  Case has been sent to Moderna safety team and they will let us know if they have any additional info to provide.
Received email from my nurse manager stating that as of April 18, monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines  are not authorized for use. I had already administered the second dose pfizer to my patient.
has been exposed and currently has a sore throat and cough; has been exposed and currently has a sore throat and cough; Sore throat; Cough; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a male patient of an unspecified age received the first dose of BNT162B2 (lot number and expiration date not reported) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is waiting for his result for today but has been exposed and currently has a sore throat and cough on an unspecified date. He is scheduled to get his second dose on 01Apr2021. The reporter asked if her husband will test positive with the COVID-19 virus, can he still get the second dose on the scheduled date or does he need to reschedule it. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Received both Moderna vaccinations 3 days apart.   March 9, 2021 and March 12, 2021.
Patient stated arm swollen and streak marks starting at shoulder extending down arm. 2 loose stool since vaccination given.
allergic reaction to an injection; Initial information received on 07-Feb-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 18 years old male patient who had allergic reaction to an injection while receiving vaccine [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE with (unknown lot number, route,unknown administration site,dose,frequency,strength)for immunization.  On an unknown date the patient had allergic reaction to an injection (injection site hypersensitivity) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken not applicable.  It was not reported if the patient received a corrective treatment for the event (allergic reaction to an injection).  At time of reporting, the outcome was Unknown for the event allergic reaction to an injection.
swelling under jaw bone the size of a golf ball; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling under jaw bone the size of a golf ball) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Knee pain (bad knee) and Surgery (2 artificial hips).   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced SWELLING FACE (swelling under jaw bone the size of a golf ball). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and Manual therapy (Ice pack) for Swelling face. At the time of the report, SWELLING FACE (swelling under jaw bone the size of a golf ball) had not resolved. Unknown          The action taken for m-RNA 1273  moderna  COVID -19 vaccine was not applicable.  No concomitant medications were provided  Treatment therapy included ice pack.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up document received on 23-JUN-2021 and contains no new information.
Post vax, had a rash the next day. Increased in severity over 48 hour period. Papular, red, confluent, raised patch at site of injection, on all extremities, face, macular feet and hands. Low-grade fever noted on date of exam, 6/8/2000.
Pt recvd 3 doses of Engerix-B, 3rd dose given 07AUG90 & it was determined that pt failed to convert to a positive HBSAB p/3 doses of Engerix-B; pt given 2 addit doses of vax 14NOV90 & 14DEC90 also resulted in failure to convert;
pt c/o severe pain & some swelling @ site of inj & high fever for 1-2 days afterward;
Pt reported she received her 1st Moderna vaccine in March without incident. She received her 2n d dose on 4/26/2021 and roughly a week later began experiencing gastrointestinal symptoms of nausea, bloating, abdominal pain, poor appetite which would come and go. These symptoms worsened over time progressing to epigastric abdominal pain resulting in pts hospitalization from August 10th 2021-Sept 5th, 2021 for severe pancreatitis. Her hospitalization was protracted requiring prolonged NG tube placement and the need for total parenteral nutrition. She was followed closely by the surgical team. Since her discharge pt is still experiencing poor appetite, abdominal bloating and pain and fatigue and is unable to work. She is awaiting a specialist to help her with future treatment and work up.
-soreness at injection site: started a few (5?) hours after injection, became worse overnight (hurt enough to wake up in pain during the night) then eased but persisted through 3-15-21 (worse than flu shot), easing to tender/ soreness to the touch through 3-16-21 (similar to flu shot), finally subsiding 3-17-21 -sneezing: started within first hour after injection, I went from not sneezing at all to sneezing at least 2x per day through 3-23-21 then it subsided
Blistering in mouth - inside cheeks and gums sensitive and bleeding, tongue very sensitive - whole inside of mouth feels raw; Blistering in mouth - inside cheeks and gums sensitive and bleeding, tongue very sensitive - whole inside of mouth feels raw; Blistering in mouth - inside cheeks and gums sensitive and bleeding, tongue very sensitive - whole inside of mouth feels raw; Blistering in mouth - inside cheeks and gums sensitive and bleeding, tongue very sensitive - whole inside of mouth feels raw; Blistering in mouth - inside cheeks and gums sensitive and bleeding, tongue very sensitive - whole inside of mouth feels raw; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 22Mar2021 14:45 (at the age of 50-years-old) as dose 1, single for covid-19 immunization.  Medical history included Hasimotos, chronic urticaria/ dermatographism flare ups (unknow causes but persistent for last 5 years), allergies to bees. Concomitant medications included levothyroxine sodium (SYNTHROID); levocetirizine; magnesium and multivitamins.  Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19. About 2 days following injection, patient experienced blistering in mouth - inside cheeks and gums sensitive and bleeding, tongue was very sensitive , whole inside of mouth feels raw. Patient did not had no such problem prior to vaccination, there was nothing unusual eaten to cause this. The outcome of the events was not recovered. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Vaccine had extended lot # and had remained frozen until date of administration.  vaccine was given 2 days past expiration date.  Moderna consulted and deemed the vaccine viable so revaccination was not necessary.  No adverse side effects were reported by patient.
Per the EUA, cases of COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Pfizer vaccine  on 2/26/2021. Patient is admitted for sepsis secondary left diabetic foot ulcer.
Significant swelling involving entire ipsilateral extremity as injection site. No hives. Angioedema involving only affected extremity.
24AUG93 t106 w/rash on face, back, arms, legs; fever persisted; t104 20AUG93 & ranged 101-103 until 29AUG93; rash fading over several days 3SEp; mom states pt fine;
Client received an inactivated polio vaccine from an opened multi-dose vial that had been subjected to temperature outside of safe storage. Temperature excursion greater than 46 deg. F occurred on 04/01/2019 for 27 minutes. Vaccinating nurse was unaware of the temperature excursion before administering vaccine on 04/02/2019.
Tinnitus in right year; Dizziness; Feeling unwell; Fatigue; Severe insomnia/takes hours to fall asleep/get about 4-5 hours of sleep that is fractured; Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (severe insomnia/takes hours to fall asleep/get about 4-5 hours of sleep that is fractured), PALPITATIONS (heart palpitations), TINNITUS (tinnitus in right year), DIZZINESS (Dizziness) and MALAISE (feeling unwell) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Mar-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form(s). On 19-Mar-2021, the patient experienced PALPITATIONS (heart palpitations). On 20-Mar-2021, the patient experienced INSOMNIA (severe insomnia/takes hours to fall asleep/get about 4-5 hours of sleep that is fractured). On an unknown date, the patient experienced TINNITUS (tinnitus in right year), DIZZINESS (Dizziness), MALAISE (feeling unwell) and FATIGUE (Fatigue). The patient was treated with TRAZODONE at a dose of 1 dosage form; ZOLPIDEM TARTRATE (AMBIEN) at a dose of 1 dosage form; CLONAZEPAM at a dose of 1 dosage form and ESZOPICLONE (LUNESTA) for Insomnia, at a dose of 1 dosage form. At the time of the report, INSOMNIA (severe insomnia/takes hours to fall asleep/get about 4-5 hours of sleep that is fractured), PALPITATIONS (heart palpitations), TINNITUS (tinnitus in right year), DIZZINESS (Dizziness), MALAISE (feeling unwell) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Electrocardiogram: normal (normal) normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.        Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Added treatment medications. Added new events malaise, dizziness, fatigue. Updated action taken.
Client did not receive full dose of vaccination. The vial that the client received the booster dose from was inadvertently diluted a second time with saline after vial was used. Department of Public Health notified and gave recommendation to report VAERS, notify client, and give recommendation to client that client received some vaccine, but not full dose. Due to receiving a partial dose, the first dose in the series will not be re-administered. Attempted to contact client and guardian to give information on 3 separate days at multiple phone numbers with no success of reaching client or client's guardian. 10/20/2021, 1332, 7123520377, recording stated "call cannot be completed". 10/20/2021, 1333, called 7122563425, unable to leave voicemail. 10/21/2021, 1633, 7123085308, left voicemail to return call. 10/25/2021, 1050 7123520377, recording "call cannot be completed". 10/25/2021, 1051, 7122563425, rang several times then call automatically hung up, unable to leave voicemail. 10/25/2021; 1052, left voicemail to return call.
OV on 4/25/10 for evaluation of RUE. Area noted to be red and swollen. Painful with movement. Due to pt. also reporting chest pain, the patient was transported to the ER. Patient was admitted with chest pain and cellulitis. Pt. was treated fluoroquinolone and clindamycin. At discharge, significant improvement was noted in the RUA. (near resolution of erythema).
feeling unwell; Stomach upset; vomiting; fever; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th July 2020 09:00, the patient received Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced feeling unwell, upset stomach, vomiting and fever. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved and the outcome of the upset stomach, vomiting and fever were unknown.   It was unknown if the reporter considered the feeling unwell, upset stomach, vomiting and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The patient was feeling unwell. The patient expereinced upset stomach though vomiting and fever of 99.3 degree F.  The reporter asked if this was a possibly a reaction to the shot.
Information has been received from a physician concerning a 13 year old male patient who on 25-NOV-1997 and 31-May-2001 was vaccinated with the first and second dose of MMR II (HSA) respectively. On 29-DEC-2009 the patient experienced mumps. The date diagnosed was 31-DEC-2009. The patient had no fever and had vomit once. The parotitis was on the left side. Lab diagnostic test performed: on 31-DEC-2009 the IgM was <1:10 and IgG was 5.82. At the time of report the patient's status was unknown. Additional information has been requested.