chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant, referring to a 68 year old female patient, whose drug reactions/allergies included penicillin allergy. The patient's concomitant therapy included receiving influenza virus vaccine inactivated (unspecified)(reported as "flu shot") in left arm on an unknown date. The patient had no pertinent medical history. On 12-NOV-2018 the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency and route were unknown. lot # R016638, expiration date: 28-JAN-2020) in the right arm for prophylaxis. "A few hours" following administration the patient began experiencing swelling, warmth, and pain at the injection site. As the day progressed the patient began having difficulty moving her right arm. The patient treated herself with heat, ice and ibuprofen. On 13-NOV-2018, the patient was seen in the office by the nurse practitioner. The patient presented with swelling, warmth and pain at the injection site, total loss of range of motion of the right arm (upper limb motor deficit) and a fever of "101"(unit not provided). The nurse practitioner told the patient to continue treating with heat, ice and ibuprofen. No lab diagnostics or studies were performed for the events. The outcome of the events was not recovered. The causality assessment was not provided by the reporter. Upon internal review, upper limb motor deficit was determined to be significant disability or incapacity.
Mild soreness below injection site the day of injection. Fever started day after injection lasting 5 days, above 100 everyday, 101 to 102.2  on the 4th and 5th days, then back to normal (97.8). Chills  and shaking on 3rd and 4th days. Mild nausea and dizziness. Stayed in bed 2nd to 4th day with fatigue. Coughing mostly when temperature was high. Still some coughing now after 10 days. Severe allergic reaction with rash starting at groin area the day after injection, moving up sides to underarms the 3rd day, then hands and feet the 4th day. Dermatologist recommended not getting 2nd shot.
Swollen, severe pain, red ring around right breast that has a titanium clip inserted. Underarms discoloration from dark to red color with ring. Vulva pain to the touch, groin pain, lower back pain. Stomach aches, swollen hot feet, hot flashes, sweating, heartburn, cheeks on face became flushed first hour after vaccination
On evening of vaccine administration, 03-28-12, developed fever, which continued until AM of 03-30-12 reports she could not lift either arm, on 04-01-12, developed hives on both knees which progressed to generalized hives by 04-02-12. Was seen by PCP, pediatrician. Vaccines ordered prior to splenectomy scheduled for 04-11-12. Temp was 103 degrees F per client.
Low grade fever, fatigue, headache lasting 4 days treated with Acetaminophen. Still tired but feeling better.
OVERDOSE (RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 67 year old female. 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 admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) 2.5 ml, administered on 31-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-OCT-2021, the patient experienced overdose (received 2.5ml of the janssen covid-19 vaccine). On 31-OCT-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the overdose (received 2.5ml of the janssen covid-19 vaccine) and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211220178, 20211220537, 20211220177, 20211220552, 20211220155, 20211220619, 20211220152, 20211220697, 20211220146, 20211220754, 20211220764, 20211219953, 20211220916, 20211220948, 20211219714, 20211219701, 20211219871, 20211219686, 20211219681, 20211219926 and 20211219731.
Child was given the two immunizations at her 12 month checkup. Call came into triage at 19:34 regarding rash. Mother was recommended to bring child to ER. No respiratory problems.
More than 36 days after the first dose without receiving the second dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE), BUPROPION and NICOTINE for an unknown indication.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
p/vax pt seen in MD office w/50 to 100 blisters in various stages of draining & crusting;
This spontaneous report as received from a physician refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II lot#M008588 (dose, expiration date, route of administration and anatomical location were not reported) for prophylaxis. From an unknown date in October 2016, the vaccines underwent multiple temperature excursions (details to be determined) which were detected by a digital data logger. No adverse effects were reported. This is one of several reports form the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1708USA003935: US-009507513-1708USA004394: US-009507513-1708USA004395: US-009507513-1708USA004393: US-009507513-1708USA004408: US-009507513-1708USA004409:
Unintentionally gave expired Pneumovax dated 04/02/2009 Lot#0963U on 5/26/09
At my 36 week prenatal appointment my baby was identified as lying in breech presentation. At 37 weeks and 2 days I underwent an External Cephalic Version under epidural anesthesia in an OR. Baby was successfully turned and remained head down at my 38 week appointment. My due date is 06/15/2021.
MODERNA COVID VACCINE, # 3 GIVEN 11/11/21, LOT #066F21A; pt had a positive COVID test on 1/12/22; 1/24/22 EMS brought pt to hosp after cardiac arrest; ROSC achieved; hypercapnic respiratory failure; possible seizures; sever anoxic encephalopathy; pt developed fevers; did not respond to ABX; pneumonia and klebsiella; pt passed away in the hospital
Swelling, redness and itchiness for 5 days. Every since taking the booster she can hold anything on her stomach. After she eats she has to run to the bathroom on top of having stomach pains.  Lost 7lbs in 6wks. Saw a GI doctor.
This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age. The unknown number of patients had received ZOSTAVAX (lot number not provided) and VARIVAX (Merck) (lot number not provided) doses which were exposed to -6.8C for 1.5 hours every 24 hours due to defrost cycle every day. No adverse effect reported. It was unspecified if the patients had sought medical attention. The health care professional contacted during telephone follow-up did not remember which patient might have received these vaccines and could not supply the following information: patient name, date of birth, dates of vaccination, or lot number. She also stated that the vaccines have been moved to a proper storage unit. Follow-up information received from the healthcare worker. Patient information was updated. On 01-OCT-2013 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (lot#, expiration date and route not reported). This is one of the several reports from the same source. Additional information has been requested.
Increased, consistent asthma.  Treated with Advair.  Then treated with Advair and Albuterol.  Now increasing the dosage of Advair but still using the Albuterol as well.  Lungs are determined to be perfectly clear.  O2 levels are perfect.  This seems to only be an issue with the airways.
sore arm; Headache; This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (Headache) and PAIN IN EXTREMITY (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and PAIN IN EXTREMITY (sore arm). At the time of the report, HEADACHE (Headache) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD21-081017, US-MODERNATX, INC.-MOD-2021-089197, US-MODERNATX, INC.-MOD-2021-089084 (E2B Linked Report).; Sender's Comments:  MOD21-081017: US-MODERNATX, INC.-MOD-2021-089197: US-MODERNATX, INC.-MOD-2021-089084:
This spontaneous report as received from a physician refers to a 73 year old male patient with no pertinent medical history and no drug reactions/allergies. On 06-FEB-2013 the patient was vaccinated with ZOSTAVAX (subcutaneous, lot#, dose/frequency and dose number were unspecified). There was no concomitant medications. On 11-FEB-2013, "5 days after administration of ZOSTAVAX", patient began to experience "dermatomal pain, allodynia and blotchy skin with no rash present". Patient had sought medical attention via office visit. No lab diagnostics studies performed and no treatment was given for the events. The outcome of dermatomal pain, blotchy skin with no rash present and allodynia were reported as not recovered. Additional information has been requested,.
A vial of vaccine was accidentally left on the counter at the end of the day on Friday 6/11/2021. On Monday 6/14/21, another nurse thought that the vial on the counter was thawed out for that day's vaccine clinic. 2 doses were drawn up and given to patients.
Pediatric monovalent dose was incorrectly administered for adult patient anticipating adult Bivalent
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.   A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2, Solution for injection), as dose 2, single (Batch/Lot number: unknown, Expiration date: Unknown) for COVID-19 immunization; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown, Expiration date: Unknown) for COVID-19 immunization. Batch/Lot number Not available/provided to reporter at the time of report completion. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "breast cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. Other medication in 2 weeks was Unknown. Past drug history included: Feldene, reaction(s): "Knonwn allergies: Feldene"; Selene, reaction(s): "Knonwn allergies: Selene"; Brethine for Knonwn allergies: brethine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective and COVID-19 which included COVID-19 treatment, brand: Pfizer from 24May2022 to 29May2022. On 26May2022, the patient experienced Nausea, gastric burning, diarrhea, dark stools. The outcome of the events were not recovered and treatment was not received.   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 available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE .
Dizziness, Headache, Sedation, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, Tachycardia, chills and fatigue. pain at the injection site. Narrative:
6-8hr p/vax T102, mult episodes emesis, 20" of unresponsiveness w/twitching of foot;
Uncontrollable screaming for hours with arching, vomiting, diarrhea at 3 weeks of age lasting months and years respectively. Food allergies to nearly all foods confirmed at 9 months of age. Behavioral issues, sensory issues, poor motor function, and developmental delays diagnosed at 19 months of age.
Information has been received from a female consumer who on 22-DEC-2006 was vaccinated IM with one 0.65 ml dose of varicella-zoster virus vaccine.  On 22-DEC-2005 the patient developed a rash at the injection site which lasted "about 24-36 hours." The patient recovered.  There was no product quality complaint involved.  No further information was available.  Additional information has been requested.
she had excessive dilation of blood vessels on the right arm injection site all the way down to the fingers; This spontaneous case was reported by a consumer and describes the occurrence of VASODILATATION (she had excessive dilation of blood vessels on the right arm injection site all the way down to the fingers) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced VASODILATATION (she had excessive dilation of blood vessels on the right arm injection site all the way down to the fingers). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 20-Aug-2021, VASODILATATION (she had excessive dilation of blood vessels on the right arm injection site all the way down to the fingers) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.  Company comment: This is a spontaneous case concerning a 78-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of vasodilation (excessive dilation of blood vessels on the right arm injection site all the way down to the fingers). The event vasodilation (excessive dilation of blood vessels on the right arm injection site all the way down to the fingers) occurred the same day after the first dose of mRNA-1273 vaccine administration with approximately 4 days duration. No reported treatment information. The outcome of the event vasodilation (excessive dilation of blood vessels on the right arm injection site all the way down to the fingers) was resolved from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-455229 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 78-year-old, female patient with no relevant medical history, who experienced the unexpected non-serious event of vasodilation (excessive dilation of blood vessels on the right arm injection site all the way down to the fingers). The event vasodilation (excessive dilation of blood vessels on the right arm injection site all the way down to the fingers) occurred the same day after the first dose of mRNA-1273 vaccine administration with approximately 4 days duration. No reported treatment information. The outcome of the event vasodilation (excessive dilation of blood vessels on the right arm injection site all the way down to the fingers) was resolved from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
On Thurs, had fatigue, body aches, fever, pain in left arm. This continued through Friday; patient felt fine by Saturday. Patient got lots of rest and drank lots of water.
pt recv vax in NOV & DEC9sss6;since then pt suffered from cold sores on the average of every 4 to 6 wk. This is in follow-up to report(s) previously submitted on 10/16/1997: 1/16/1998. Information has been received from a consumer, a 47-year-old male who was vaccinated with the first and second dose of varicella vaccine six weeks apart in November and December 1996. "Since then, he suffered from cold sores so the average of every 4 to 6 weeks." No further details were provided. This is an amended report. The date of vaccination was added and the adverse onset date was updated. This report is corrected as amended.
My arm still has pain in the local area where I received the shot.  It is a dull ache about a 2-3 on scale and persistent.  It feels deep as if in the bone.  There is no rash or swelling and never was a rash or swelling. This persistent ache is over a month now and has not diminished.  I did have mild fever and felt puny 2 days after the shot which is fine/expected and that went away.  The arm pain concerns me.
today (01FEB2023) received 0.5 ml dose instead of 1 ml dose in error.; today (01FEB2023) received 0.5 ml dose; Caller said the patient had gotten antibody test a week ago and it showed non-immune to RECOMIBAX; This spontaneous report was received from a physician assistant, referring to a 55-year-old female patient. The patient's concurrent conditions, medical history, concomitant therapy and drug reactions/allergies were unknown.  On an unknown date in 2014, the patient was vaccinated with the first dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (dose, lot number, expiration date, route and anatomical location were not provided) for prophylaxis. On an unknown date in 2014, the patient was vaccinated with the second dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (dose, lot number, expiration date, route and anatomical location were not provided) for prophylaxis. On 01-FEB-2023 (reported as today), the patient was vaccinated with the third dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (thimerosal free) (0.5 milliliter (ml), lot number W022795 has been verified to be a valid lot number, expiration date was reported as 19-MAY-2025, route and anatomical location was not provided) instead of 1 ml dose in error for prophylaxis (incorrect dose administered and inappropriate schedule of product administration).  On 25-JAN-2023 (reported as a week ago), the patient had gotten antibody test and it showed non-immune to hepatitis B vaccine (recombinant) (RECOMBIVAX HB). The sought medical attention on patient was reported as unknown. The outcome of non-immune to hepatitis B vaccine (recombinant) (RECOMBIVAX HB) was not provided. The causality between hepatitis B vaccine (recombinant) (RECOMBIVAX HB) and non-immune to hepatitis B vaccine (recombinant) (RECOMBIVAX HB) was not provided.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced PYREXIA (Fever). On 30-Aug-2021, PYREXIA (Fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Sep-2021, Body temperature: 103 (High) 103 degree Fever at 11AM. On 28-Sep-2021, Body temperature: 102 (High) 102 degree Fever at 11 AM. On 29-Sep-2021, Body temperature: 101 (High) 101 degree Fever 11AM.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
This spontaneous case was reported by a consumer and describes the occurrence of ANHIDROSIS (Anhidrosis) and PSORIASIS (Psoriasis flare-up) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced ANHIDROSIS (Anhidrosis) and PSORIASIS (Psoriasis flare-up). At the time of the report, ANHIDROSIS (Anhidrosis) and PSORIASIS (Psoriasis flare-up) had not resolved.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  The patient had flare up with itching and new spot since starting Skyrizi. He complained of cracked feet and extremely dry hands. He had inability to sweat, he explains that he works out weekly and must be aware of his heart rate due to not being able to sweat while exercising. It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
About 6 hrs after receiving vaccines became irritable, crying & inconsolable for 1 1/2 hrs.  Left leg had nickle sized bruise at injection site.  Left thigh looked swollen.  Both feet + left leg were pink.  No fever.  Resolved in 24 hrs except for bruise.