chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt has recurrent febrile infections of unknown origin.  Different multiple antibiotic therapies for fevers; hospitalization three times for fever and hematemesis as an infant. Pain in leg, red rash below inject site.  See comments. Information has been received from a registered nurse concerning an 8-year-old male patient with a history of immunodeficeincy not yet verified, "cdiff. multiple antiobiotic therapyies for fevers, hospitalization times three for fever and homemesis as an infant, normal growth and development at this point with past speech therapy" who on 15-NOV-1999 was vaccinated with PNEUMOVAX (lot number: 630097/0045J) in the thigh. On 16-NOV-1999, the patient had a fever of 105.5F and severe pain in the left leg where the PNEUMOVAX was administered. The patient was seen by a physician on 17-NOV-1999 and would not bear weight on the left leg because of pain. The injection site did not look affected, however, 3 cm below the injection site a small red rash had begun to form. The physician felt the patient was having a local reaction but because of this history of fevers, the patient was hospitalized. He had a WBC of 16, 000. Sed rate of 50, and a C-reactive protein of 26. He was admitted for antibiotics and what might be developing cellulitis. The patient never had a positive bacterial growth from the site or from his blood. He completely recovered and was discharged by 20-NOV-1999. Two additional patients (WAES #00020066 and #00020074) had similar experience following exposure to PNEUMOVAX. Additional information has been requested.
loosing sleep; During the injection some of the vaccine spilled down his arm/must have missed the portion of the dose; during his second dose the vaccine came out of a joint; This spontaneous case was reported by a physician and describes the occurrence of INSOMNIA (loosing sleep), UNDERDOSE (During the injection some of the vaccine spilled down his arm/must have missed the portion of the dose) and DEVICE CONNECTION ISSUE (during his second dose the vaccine came out of a joint) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included Back pain in 1978. Previously administered products included for an unreported indication: neck pain in 1978. Concurrent medical conditions included Immunocompromised (lost his spleen 42 years ago), Allergy to animal dander, Insomnia in 2000 and BPH in 2000. Concomitant products included TAMSULOSIN for BPH, METAXALONE for Back pain, OMEGA-3-ACID ETHYL ESTER (LOVAZA) and ROSUVASTATIN for High cholesterol, TRAZODONE for Insomnia, MELOXICAM for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced UNDERDOSE (During the injection some of the vaccine spilled down his arm/must have missed the portion of the dose) and DEVICE CONNECTION ISSUE (during his second dose the vaccine came out of a joint). On an unknown date, the patient experienced INSOMNIA (loosing sleep). On 23-Mar-2021, UNDERDOSE (During the injection some of the vaccine spilled down his arm/must have missed the portion of the dose) and DEVICE CONNECTION ISSUE (during his second dose the vaccine came out of a joint) had resolved. At the time of the report, INSOMNIA (loosing sleep) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   meloxicam used as anti inflammatory medication. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow-up information received contains no new Information. On 03-Aug-2021: Follow up received on 03 Aug 2021 contains added medical history, concomitant medications, added event - Insomnia
DEATH; CLOT BLOOD; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose not reported, dose number in series was 1, 01 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient was full of blood clots (clot blood) and got corona virus disease (COVID)-19 (suspected covid-19 infection) which resulted in suspected clinical vaccination failure. On an unspecified date, the patient died a very painful and unnecessary death from an unknown cause (dose number in series was 1). It was not reported whether autopsy was performed or not. The reporter reported that, "My brother had Johnson and Johnson vaccine and got Covid and was full of blood clots. He ended up dying a very painful and unnecessary death. I blame them". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date and the outcome of suspected covid-19 infection, clot blood and suspected clinical vaccination failure was not reported. This report was serious (Death and Other Medically Important Condition). This report was associated with product quality complaint.: 90000211571. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Version created to amend previously reported information on 20-JAN-2022. Upon review the following information was amended: Amendment Adverse Event (The case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V2:This version updates: The case validity assessment was updated to valid from the previously incorrect assessment of non-valid. The prior causality assessment remains unaltered with this added information. 20220123845-COVID-19 VACCINE AD26.COV2.S-Death, clot blood. This event(s) is considered unassessable. 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). 20220123845-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
patient was fine until tuesday night and then developed high fever, ha, nausea, muscle aches. then wednesday she had itching that started at sites other than where the imz was given. i spoke with her and she states that she is on bactrim too which we thought this may be a reaction to the antibiotic.  she contacted her dr's office and they wanted her to come in for an appointment on thursday.   she went to appointment on thursday and the provider thought it may be a reaction to the bactrim due to the type of rash but was unsure about the delayed high fever and nausea which could be attributed to the shot.
Gave product outside of indication (indicated at 6 months, but gave to 2 month old child) (with no reported adverse event); Initial information received on 30-Nov-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 2 months old patient of unknown gender who was administered Influenza quadrival A-B vaccine [Fluzone QIV] outside of indication (indicated at 6 months, but gave to 2 month old child) (with no reported adverse event).  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 influenza Quadrival A-B vaccine Suspension for injection (strength, dose, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event gave product outside of indication (indicated at 6 months, but gave to 2-month-old child) (with no reported adverse event) (product administered to patient of inappropriate age) (unknown latency) following the administration of influenza quadrival A-B vaccine.  No lab data was reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (Gave product outside of indication (indicated at 6 months, but gave to 2 month old child) (with no reported adverse event)).  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.
Pt recvd vax 1030AM fainted & fell forward approx 1038; 1041 back in office, color pale, lips blue, bradycardic (HR 40/min), pulses thready; diaphoretic;
Patient received first dose of Shingrix on 06/18/2019. When we called to remind her to get a second dose on 8/23/19, she let us know of adverse reactions which occurred after getting first Shingrix vaccine. The evening after receiving the vaccine, the patient said that she starting sweating and feeling poorly. She was tired and went to sleep. She said she woke up 5 hours later and could not move half of her body. She was admitted to the hospital and spent 3 days in the hospital. She said she did not notify us sooner because she knew it was not our fault, but her primary care provider was made aware. I spoke with  her PCP office and they confirmed they were aware of the reaction and it was documented in the patient's chart.
Patient came in to the  pharmacy the Monday following a Saturday flu shot. Her arm had a red circle about 1.5 inches in diameter. She said it did not itch or hurt. It was not hot to touch or swollen. Advised her to take some BENADRYL and let us know if it gets worse.
Muscle aches and pains; joint pain; headache; chills; general malaise; nausea; Significant pain at the injection site; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 at 15:15 (at the age of 57 year) as dose 1, single for COVID-19 immunisation at Hospital. Medical history included Lyme. Patient had known allergies to Trileptal. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient previously took Trileptal and experienced drug hypersensitivity. On 10Mar2021 at 06:30 patient experienced muscle aches and pains, joint pain, headache, chills, felt like have a fever but don't, general malaise, nausea and significant pain at the injection site. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I did not have an adverse reaction to dose 4 of the Covid 19  vaccine.  I started felling sick on the morning of June 9. I took a home test and it was positive.  I went to Covid 19 testing center and received the PCR test and it was positive.  My symptoms: body ache, sore throat, sinus congestion, coughing, mild temperature and fatigue. I was prescribed Paxlovid on June 10.
pt states she has a colotomy bag and started throwing up mucus and had diarhea.  Pt states she could not eat for 2 weeks because of this.  She also had no taste and no smell for 4 weeks.  She had fever of 101.2  that would develop mostly at night.  She was also dizzy and had chills with cold sweat and hot flashes.  She was never tested for Covid but had all symptoms and her fiancé tested positive 3 weeks after she was vaccinated, so she and her GI doctor believe she had the virus.  After speaking with her GI doctor, she was told to hold off on 2nd dose or do without it since she had such a bad reaction.  She no longer has any symptoms.
Rash on lower legs similar to that seen with Thrombocytopenia.; Rash on lower legs similar to that seen with Thrombocytopenia.; This is a spontaneous report from a contactable Other HCP (patient). A 21-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number= EJ1686), via an unspecified route of administration at Left arm on 05Jan2021 10:00 AM at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient's medical history and concomitant medications were unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on lower legs similar to that seen with thrombocytopenia on 09Jan2021 at time of 12:00 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was not recovered.; Sender's Comments: A possible contributory effect of suspect drug on reported thrombocytopenia cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
tested for covid; tested for covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 at 14:00 as dose 4 (booster), single at the age of 67 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLONAZEPAM, start date: 01Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 22Jul2022, outcome "unknown" and all described as "tested for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2022) positive, notes: a positive test for covid; (30Jul2022) positive, notes: I tested for covid. My test was a solid clear positive result. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No known allergies. Yes patient received other medications with in 2 weeks. Patient took Plaxovid, full strength for 5 days starting first day of symptoms, and a positive test for covid. 9 day after starting Plaxovid a runny nose presented, and patient tested for covid and his test was a solid clear positive result. Took treatment on 22Jul2022 to 27Jul2022. Other medications include Clonazepam on 01Jan2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
pt recvd vax; pt exp serum-sickness like effect w/ erythema multiforme & jt swelling;
This solicited report was received from a physician referring to a 65 years old female patient enrolled in a marketing research program. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2014, the patient was vaccinated with her first dose of ZOSTAVAX, one time injection (route of administration, lot# and expiry date were not reported). On an unknown date in January 2016, the patient went down with "mild case" of shingles that lasted approximately 3 days after receiving the ZOSTAVAX. The patient recovered with sequelae from the event on an unknown date, 3 days after the onset of shingles. Causality assessment was not provided. This is one of several cases from the same reporter. Additional information is not expected, as there was no consent for follow up.
Patient stated that they did not receive any previous COVID-19 vaccinations. Moderna vaccine was administered. Patient's insurance kicked back because they did receive both doses before.
Patient called pharmacy late in day in 5/11 stating  she got her shot on 4/29 and sore arm few days after shot and then on 5/1 (wed) she developed 101 fever and chills that lasted until 5/3 (fri). She says fever resolved but she then got dizziness and nausea on 5/4 to 5/6.   She says then she developed body aches, nasal congestion, coughing, low grade feverof 100 on thurs 5/9 up until she called sat 5/11.  We told her to call MD or see MD since she started having fever again. She said she is going to call MD Monday and try to see her if she is not better. She said if she felt worse on Sunday she would go to immediate care.  We told her we would follow up with her Monday to see how she feels. We told her normal side effects include sore arm, fever, headache, muscle aches, fatigue.
The patient became COVID symptomatic on 27 Apr 2021, and tested COVID (+) on 29 APR 2021. He was fully vaccinated including the 14 day period following vaccination #2. on 22 APR 21.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. The reporter stated that on unknown dates, the patient who is older than 26 years of age, was vaccinated with 3 doses of GARDASIL 9, intramuscularly (lot#, expiration date and indication were not reported). No adverse effects reported. Additional information is not expected because there was no consent to contact the reporter.
DIARRHOEA; GAS; MUSCLE CRAMPS; HEADACHE; TIRED; WEIRD FEELING; FLUSHING BUT NOT FLUSHED; TINGLING OF FACE AND HANDS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included threw up, and concurrent conditions included high blood pressure, high cholesterol, sulfa drugs allergy, non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient not had any drug abuse / illicit drug use. the patient was non alcoholic and non smoker. The patient experienced drug allergy when treated with clindamycin, codeine, and azithromycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: 26-MAY-2021) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced weird feeling. On 12-MAR-2021, the subject experienced flushing but not flushed. On 12-MAR-2021, the subject experienced tingling of face and hands. On 12-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced tired. On 14-MAR-2021, the subject experienced muscle cramps. On 16-MAR-2021, the subject experienced diarrhoea. On 16-MAR-2021, the subject experienced gas. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from diarrhoea on 16-MAR-2021, and headache on 14-MAR-2021, and had not recovered from weird feeling, flushing but not flushed, tired, tingling of face and hands, muscle cramps, and gas. This report was non-serious.
Severe nausea; weight loss over 20 lbs; dizziness; balance problems; impaired concentration; vertigo; inflammation of esophagus; abdominal pain, especially 30 minutes to 1 hour after meals; difficulty with speech articulation, impaired short term memory/recall; bilateral hand tremors; extreme fatigue; shortness of breath.  7/29/09 Consultant medical records received DOS 6/30/09. Assessment: Cerebellar tonsillar ectopia. Patient presents with headaches, dizziness, nausea, weight loss, fatigue, and low-lying cerebellar tonsils. Lack of endurance when running. Can hear pulse in ears. Balance disturbance. Occasional high blood pressure. Nausea and pain after meals. Fasciitis. Vertigo.
patient has to push second dose out 10 days; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (patient has to push second dose out 10 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (patient has to push second dose out 10 days). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (patient has to push second dose out 10 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided by the reporter.