chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a female patient who "approximately one month ago" was vaccinated with a dose of GARDASIL (lot# not available). Subsequently, the patient experienced syncope 15 minutes after vaccination. The patient contacted the nurse for medical attention. The patient recovered on the same day the adverse effect occurred. Additional information has been requested.
She developed thrombocytopenia - platelets dropped from normal of 255k 12/2016 to 115k on 4/26/17, which is a few weeks after the MMRV. Counts have remained between 18k and 50k since then and she has been diagnosed with ITP. She has not had any bleeding, but has had some increased bruising and petechiae.
Fullness in throat, swallowing felt "tight", numb/tingling lips/gums/throat within minutes of vaccine. Told not to administer Epi-pen per PA (no airway swelling per PA). Took 25 mg po Benadryl and able to drink 500 mL water while in clinic.  Symptoms persisted for about 4-5 hours after. Swallowing felt abnormal for the remainder of the day. For days after, throat felt "raw" and multiple aphthous ulcers noted in mouth (gums/inner cheeks).
The wife came by the store stating that her husband got a rash on his left arm. She said is began a few days and believes it is from the vaccination.
-stiff arm for 11 days. -Felt thick and gooey when injected
extended moderate diarrhea and lower back ache (not pain) from soon after second shot to current time
Baby was brought in today by her mother. Mom reported to the doctor about SXs 30 days after her 1st dose of ROTATEQ. Intussusception per Dr. . Reduced with air contrast enema.  6/5/09 Medical records received DOS 4/30/09 to 5/1/09. FINAL DIAGNOSIS: Intussusception, dehydration, vomiting. Post vaccination presented with vomiting, face swelling, tugging at ears. Decreased intake liquids. Crying. Difficulty waking up.  6/5/09 Discharge summary received DOS 5/1/09. FINAL DIAGNOSIS: Intussusception Post vaccination presented with crampy abdominal pain and bloody stools. Vomiting.
I began to have pain under my left arm as well as a lot of pain in my left foot (without sustaining an injury). Additionally,  I have had all over body aches and chills. All symptoms are still ongoing.
The patient was vaccinated with expired M-M-R II on 4/29/2019; This spontaneous report was received from the medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history.   On 29-APR-2019, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHa) (M-M-R II) (expired vaccine used) lot # N025889, expiration date reported and validated as 18-APR-2019 (formulation, strength, dose, frequency, route of administration, anatomical location and indication were not reported).
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 23-MAR-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This one of the several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
nausea within 48 hours of vaccination, lasting 3+ days (acerbated by heat and humidity); diarrhea within 8 days of vaccination, lasting 2+ days symptom still present; sweating within 48 hours of vaccination, lasting 7+ days (acerbated by heat and humidity); sensation of warmth within 8 days of vaccination, lasting 2+ days symptom still present; lightheadedness within 8 days of vaccination, lasting 2+ days; and flushing within 8 days of vaccination, lasting 2+ days symptom still present
Pain in shoulders, arms, hands.  Painful numbness and tingling in forearms and hands.  Pain and numbness greater on the Left side, where the injection was given.  Weakness and partial paralysis of both hands.  Hands turned a frightening shade of intense gray.  Episode lasted for a total of several hours, maybe 3 or 4 hours before essentially total resolution.
This is a spontaneous case, initially received on 03-Oct-2018, reported by other health professional (pharmacist), concerning a 56-year-old, adult, female patient. The patient's current condition included hyperlipidaemia and hypertension (reported as medical history). The patient didn't receive any concomitant medications. On 03-Oct-2018, the patient was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid batch number: 252668 and expiry date: 30-Jun-2019). On the same day, within few minutes, the patient experienced swelling of area and developed a hardened area (reported as goose egg), with no bleeding and bruising. It was reported that, the patient had some itchiness. The patient did not receive any treatment medications at the time of the report. At the time of the report, the outcome of the events was unknown. The reporter assessed the case as non-serious. Follow up report received on 05-Nov-2018: The expiry date of the product was confirmed as 30-Jun-2019. Hence, the expiry date (30-Jun-2019) was updated in the product tab and the event 'expired product used' was deleted from the event tab. The narrative and case comment were amended accordingly.
Patient was given KINRIX instead of individual doses. It was later discovered that patient was given KINRIX which is only for 4-6 year old patients. Call was placed to the state and we were informed that patient would not need to be revaccinated and that patient would not have any adverse reactions to vaccine. Advised on making sure proper labeling, protocols, verifications, and training are done to insure that this doesn't happen again.
This spontaneous case reported by a consumer, describes the occurrence of adverse event (wants to report adverse event) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Oct 21, 2021, patient experienced an adverse event (wants to report adverse event). At the time of the report, adverse event (wants to report adverse event) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
typed document given to us by patient states within 12 hours he developed a debilitating negative reaction to the shot. In addition to fever, aches, and pains the shot caused his body to develop an autoimmune response. Patients immune system began attacking healthy cells within his body which resulted in intestinal bleeding which lasted more than 3 months. The bleeding was accompanied by frequency, urgency, pain, cramps , fatigue, exercise intolerance, and severe anxiety.  According to patient he was referred to gastroenterologist by his primary care physician and his treatment included mesalamine and VSL#3.
difficulty with movement; This spontaneous report was received from a consumer (also a social worker) regarding her son a 4-year-old male patient. Patient had no drug allergies or reactions. Concomitant therapies included sterile diluent. Currently patient had a genetic condition Ataxia telangiectasia which was diagnosed when he was 2 and half years old (it was mentioned that condition was not due to vaccination with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)).  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose 1 (route of administration, anatomical location, lot # and expiration date were not reported) as scheduled immunization (as it was recommended by patient's physician). On an unknown date patient experienced difficulty with movement (movement disorder). Patient refused to answer that was treatment given for adverse event or not. The outcome of movement disorder was reported as not recovered. Causality assessment was not provided.
Initial reaction was a bruise. Seven days after first vaccine, an itchy rash of 2" x 2.5" occurred. Monitoring it to see if it worsens.
This case was reported by a healthcare professional and described the occurrence of peeling of skin around injection site in a 2-year-old female subject who was vaccinated with Havrix (GlaxoSmithKline). On 28 August 2007, the subject received an unspecified dose of Havrix (unknown, left arm). Within 3 to 5 days vaccination with Havrix, the subject experienced peeling of skin around injection site, and injection site redness that had a burn-like appearance. the subject was seen in the physician's office (treatment unspecified). At the time of reporting the events were unresolved.
Mother phoned 3/16 reporting at 12:30 pm today noted red raised areas on arms, back, thighs. Had given Motrin x 1; during night slightly fussy, no fever. 3/19/07 phone call from mother, brought child to urgent care 3/17. 3/10 doctor diagnosed reactive hives from Hepatitis A injection.
she is been indolent for a month; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "had a little reaction after the first dose of the vaccine". The following information was reported: LAZINESS (non-serious), outcome "unknown", described as "she is been indolent for a month".  Additional information: The patient had both doses of the Pfizer BioNTech covid vaccine and need to report side effects. Patient had a little reaction after the first dose of the vaccine. But the second dose of the vaccine really kicked, patient had been an invalid for a month since getting the second dose. After getting second dose she stated she hab been indolent for a mont  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, Chills, Body Aches, Headaches, Upset Stomach, Diarrhea, and Injection Site Swelling.
DID NOT TAKE THE LAST DOSE; This spontaneous case (PVX2019-713) was received from a caregiver on 25-Mar-2019. It describes a male consumer who "did not take the last dose", while being on Vivotif for an unknown indication.   Case report: The consumer took 3 doses of Vivotif correctly but he did not take the last dose, which was due on 17-Mar-2019. The reporter also stated that he was travelling to another country.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "did not take the last dose" was unknown.  Company's Comment: The causality of the event "did not take the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take the last dose" was considered as not applicable.
DURING A COVID OUTREACH CLINIC AT FACILITY, PFIZER BIVALENT VACCINE ADMINISTERED ON 11/09/22. CONSENT WAS FILLED OUT BY FACILITY STAFF AS PATIENT IS NON-VERBAL, WITH CONSENT SIGNED BY FACILITY DIRECTOR. MOST RECENT DOSE DOCUMENTED IN SIIS WAS 10/17/22. NOT DOCUMENTED ON CONSENT. NO ADVERSE SIGNS AND SYMPTOMS OR OUTCOMES OCCURRED. NO TREATMENT REQUIRED.
This spontaneous report was received from a nurse practitioner concerning a patient of unknown age and gender who on 26-OCT-2012 was vaccinated with dose 1 of live, oral ROTATEQ (route, lot number and expiration date were not provided) and on 20-DEC-2012 was vaccinated with a second dose of live, oral, ROTATEQ that had expired on 13-DEC-2012 (Lot number reported as 0229AA) (route was not provided). No adverse effects reported. Additional information has been requested.
Vaccine administered to unauthorized age Moderna only authorized for ages 18 or older Moderna vaccine dose inadvertently administered to 17 year old
Pt should have received a pediatric dose of 0.2ml, but was administered the adult 0.3ml dose.
Problem getting an erection; Sick in bed; Lost my taste buds; Body was sore; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (Problem getting an erection), VACCINATION COMPLICATION (Sick in bed), AGEUSIA (Lost my taste buds), MYALGIA (Body was sore) and PYREXIA (Fever) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION COMPLICATION (Sick in bed), AGEUSIA (Lost my taste buds), MYALGIA (Body was sore), PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced ERECTILE DYSFUNCTION (Problem getting an erection). On 30-Mar-2021, VACCINATION COMPLICATION (Sick in bed), MYALGIA (Body was sore), PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, ERECTILE DYSFUNCTION (Problem getting an erection) outcome was unknown and AGEUSIA (Lost my taste buds) had resolved.            No concomitant product was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Significant follow-up received included :Repoter details and events were updated.; Sender's Comments: This case concerns a 48-year-old male patient with no previous relevant medical history, who experienced the unexpected non serious event/AESI of Ageusia and other non serious events after mRNA- 1273 vaccine / Moderna COVID-19 Vaccine. The event occurred on the days after the second dose of mRNA-1273 and lasted for approximately one day. The rechallenge is not applicable, since the schedule of vaccination has been completed and a further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Case number PHEH2016US023352, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 46 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in left arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error.
COVID-19 in January 2021 - No Gastrointestinal issues, mild soreness in arm and mild fatigue after second dose. July 9th, 2021, chronic watery diarrhea - Bristol scale 7.  Primary Care Physician on October 11th, 2021. On October 24th, saw Gastrointestinal doctor, everything was normal. Pain in abdomen on October 20th for one week and increase and went to Emergency Room and still having diarrhea. More bloodwork  normal.
Had diffulty breathing 3 hrs after shot             Used advair helped breathing Leg and hip aches after 9 pm.                                    Nothing helped leg pain for 3 days Headaches and nausea  Tues, Wed. Thursday.  Extreme tiredness
A red rash on injection arm that has not gone away and a red rash that showed up on my neck, back and chest that comes and goes.
Diarrhoea; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Diarrhoea) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Diarrhea from 12-Mar-2021 to 07-Jul-2021. Concurrent medical conditions included Cardiac disorder NOS and Drug allergy (allergy to oxycodone). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN, B COMPLEX WITH C, FUROSEMIDE, IRON, LEVOTHYROXINE, MECLIZINE [MECLOZINE], METOPROLOL, OMEGA-3 FATTY ACIDS, OMEPRAZOLE, PYRIDOXINE, SERTRALINE, TAMSULOSIN, THERAGRAN-M [ASCORBIC ACID;CALCIUM CARBONATE;COPPER;CYANOCOBALAMIN;ERGOCALCIFEROL;IODINE;IRON;MAGNESIUM;MANGANESE;NICOTINIC ACID;PANTOTHENIC ACID;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHEROL;ZINC], OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) and WARFARIN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Diarrhoea) (seriousness criterion hospitalization). The patient was hospitalized on 29-Mar-2021 due to DIARRHOEA. The patient was treated with COLESTIPOL for Diarrhoea, at a dose of UNK, qd and PLANTAGO OVATA (METAMUCIL CITRON) for Diarrhoea, at a dose of UNK, qd, 10-15 tabs. At the time of the report, DIARRHOEA (Diarrhoea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Stool analysis: negative (Negative) 3 different stool samples are submitted.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient is experiencing constant 6-7 time diarrhea.  The patient underwent colonoscopy and blood test results unknown.  Company comment: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received on 7-Jul-2021 Updated patient demographics- occupation changed from consumer to physician , medical history, lab data, added concomitant medicines and treatment medicines, event diarrhea updated(non-serious to serious) , patient admitted to hospital; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
After administering vaccines, we noticed regression and skills and he became increasingly despondent. The follow up states, "diagnosed with PDD."  60 month follow up: "Vaccine recipient did not recover from adverse events.  He is autistic and lost skills he is beginning to regain inconsistently.  He continues to struggle with absent thinking.  Concepts and communication.  Very little verbal language.  Hard to focus."  Follow up on 12/03/03: "Immunization record received." The medical record received on 2/12/04 states hearing loss, speech delay and headaches. Annual follow up on 03/05/04: "Pt has not recovered from adverse events.  Autism, communication, learning problems and complex behavrious exhibited."
Pt received vaccination and on same day noticed swelling, raised soft non-tender areas, bilaterally above clavicles.  Denies other sx's, mild sore throat on following morning.  Given Benadryl and motrin, pt discharged.
almost didn't hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date, refer case US2022AMR164334).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR164334   Additional Information: GSK Receipt Date: 07-NOV-2022 Reporter's comment: : This case was reported by a patient via interactive digital media. The patient just got the second dose of Shingles vaccine and experienced pain. The patient also stated that it almost didn't hurt, it went very bad with the first one, but he/she was fine at the time of reporting.  The patient's doctor told him/her that he/she could get a shingles vaccine. Additional supportive information: The follow-up would not possible, as no contact, details were available.; Sender's Comments:  US-GSK-US2022AMR164334:same reporter and patient
pt recv 2 doses of varicella vax & lab eval 6-7 wk post vax revealed 11 neg titers & 6 equivocal titers;1 pt devel lesions;
Patient had previously tested positive for COVID-19 on 8/22/21.  Patient was a resident of Facility and was admitted to  Hospital on 10/13/21 with fever, confusion, lethargy.  Notes state that he was admitted to the ICU, but did not require any mechanical ventilation during the hospital stay.   Date of discharge was not reported.  Patient expired on 10/28/2021 at Facility with cause of death listed as sudden cardiac arrest, congestive heart failure, hypertension, diabetes.  Was NOT reported as a death caused by COVID-19.