chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Eye irritation in the left eye; Fluad vaccine being splashed into her left eye; This is a spontaneous case, initially received from a pharmacist via Agency (reference number: SEQ19-05951) on 31-Oct-2019 and processed together with an additional source document received on 01-Nov-2019, concerning a 26-year-old pharmacist.   No medical history and concomitant medications were not provided.   On 25-Oct-2019, while was administered Fluad TIV to the patient [influenza vaccine, inactivated influenza virus surface antigen, egg-derived, MF59, batch number: 260397 and expiration date: 30-Jun-2020] and after retracting the needle, the pharmacist reported she thought some of the vaccine splashed into her left eye (explicitly coded as 'Occupational exposure to product via eye') . The pharmacist flushed the eye with water and stated it was ok.  On 29-Oct-2019, the pharmacist reported eye irritation in the left eye, but no redness. She did not see a physician.  On an unknown date in Nov-2019, at least a week after experienced eye irritation in the left eye, the pharmacist recovered.   The case was assessed as non-serious. The reporter did not provide causality assessment to Fluad (TIV).  Follow-up received from a pharmacist via Agency (reference number: SEQ19-06736) on 18-Nov-2019: The pharmacist's age were added. The outcome of the event eye irritation was changed from not resolved to resolved. The narrative was amended accordingly.   Company comment: The pharmacist experienced eye irritation after occupational exposure to suspect product Fluad TIV. Reportedly, some of the vaccine splashed into her left eye. Chronology is plausible. Occupational exposure to product is assessed as not related per company's conventions. For eye irritation, causality between suspect product and the event is assessed as possibly related.; Sender's Comments: The pharmacist experienced eye irritation after occupational exposure to suspect product Fluad TIV. Reportedly, some of the vaccine splashed into her left eye. Chronology is plausible. Occupational exposure to product is assessed as not related per company's conventions. For eye irritation, causality between suspect product and the event is assessed as possibly related.
Headache, Myalgia, Arthralgia, NauseaVomiting, LIGHTHEADED, FATIGUE Narrative:  Other Relevant History:
Eyelids started twitching the day after 2nd dose of vaccine; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on 05Feb2021 as SINGLE DOSE for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. On 06Feb2021, the patient's eyelids started twitching the day after 2nd dose of vaccine. The patient did not receive any treatment for the event. The outcome of event unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
1st shot I got gout (1st time ever) in my left big toe. 2nd shot I got gout in my right big toe.
Severe bouts of diarrhea for ten days, resulting in irritation and bleeding. Took Imodium to attempt to control.   Other reactions were expected: arm sore for 4-5 days, low grade fever for one day.   Still have bouts of diarrhea that were not occurring prior to receiving the shot.
pt recvd vax 1DEC93 & was found to be pregnant (LMP 4NOV93); 39 wks gestation pt went into labor; exp a slow progression of labor & it was felt that baby was too large for vaginal delivery; 16AUG94 pt delivered an 8lb 15 oz healthy baby boy
swollen face; This is a spontaneous report from a non-contactable female consumer via Pfizer-sponsored program  support. A 71-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, on an unspecified date the patient was extremely upset that they had not responded to her reports of adverse event from both doses; she was in bed for four days with swollen face that lasted weeks. She received letter from department of health stating not to receive second dose as second reaction could be worse (after both doses), and she was upset as she did not know to get second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 06-NOV-2015, the patient was vaccinated with ZOSTAVAX (0.5 ml, Lot # L024997, expiration date: 06-OCT-2016), which was improperly stored for 44 days. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
painful reoccurring rash; Information has been received from a lawyer regarding a case in litigation referring to a male patient (pt) of unknown age. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. Shortly after receiving the vaccine, the pt suffered a painful reoccurring rash. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms have resulted in physical limitations not present prior to being vaccinated. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the company's conduct, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of company's conduct, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. Outcome of the event was reported as not recovered; causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  The reporter considered rash to be a disabling event.
patient is two days late for their second dose of pre-exposure prophylaxis with no reported adverse event; Initial information received on 09-Jun-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was two days late for their second dose of pre-exposure prophylaxis with no reported adverse event while receiving vaccine IPV (VERO) [IMOVAX].  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 IPV (VERO) lot number not reported via unknown route in unknown administration site for prophylactic vaccination  On an unknown date the was two days late for their second dose of pre-exposure prophylaxis with no reported adverse event (inappropriate schedule of product administration) (unknown latency). It was asked "how to proceed with the second dose"  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event patient is two days late for their second dose of pre-exposure prophylaxis with no reported adverse event.   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.
Information has been received from a registered nurse concerning a male patient who in 1991 was vaccinated with one dose of Hepatitis B vaccine recombinant. Subsequently, in 1991 the patient developed a rash and edema. Unspecified medical attention was sought. Subsequently, three weeks later, the patient recovered. Follow up reported that no further information is available.
Migraine headache started 24 hrs after 2nd dose on 03/15/2021. It was continuous for 8 days, even while taking prescribed medication. With the exception of two (2) days since then, I have had a migraine which required at least one to two doses of medication to alleviate. My physician was informed  of this on June 3, 2021.. which he stated he?d not heard of this reaction before.  He has increased my medication to a larger dose of 50 mg, and scheduled a follow up exam in mid September.
PATIENT HAD A RED, SWOLLEN AREA AROUND INJECTION SITE. DOCTOR TREATED PATIENT WITH BACTRIM DS FOR 7 DAYS AND A STEROID SHOT IN OFFICE.
Patient received moderna vaccine on 1/26/21, 2/23/21, and 11/6/21. COVID positive on 4/29/22. Presented to ER on 4/29/22 and admitted. She sustained a right femoral neck fracture after a mechanical fall at home and therefore admitted. She was also noted to be COVID-19 positive (asymptomatic) upon admission. Discharged on 5/3/22
fever to 104 (orally), vomiting at night, nosebleed in am
This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling in a child subject of unspecified gender who was vaccinated with (KINRIX, GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown) for the fifth dose of (DTaP). An unspecified time after vaccination with KINRIX, the subject experienced swelling. At the time of reporting the outcome of the event was unspecified. The sales representative was told of three cases of swelling in children given KINRIX for the fifth dose of DTaP. She was told that one of these cases was reported to the physician by the parents and the physician never saw the swelling. The sales representative did not have any subject specific information. She was told that the physician filled out a VAERS report. Please see A0780793A and A0780846A for the two additional reports of swelling.
approx 2-3 hrs p/dose of vax in lt arm; area became very swollen w/mod erythema, warm to touch; arm swelled progressively to entire hand by 3rd day;
patient had  large bumps at lympnods under both arms, a localized itchy rash, and "lines coming from he injection site"
a nurse inadvertently gave a dose of the Moderna COVID19 vaccine to 17 year old patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a nurse inadvertently gave a dose of the Moderna COVID19 vaccine to 17 year old patient) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Shellfish allergy. Concomitant products included MELATONIN, AMITRIPTYLINE and NORTRIPTYLINE for an unknown indication.    On 29-Jul-2021 at 9:33 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a nurse inadvertently gave a dose of the Moderna COVID19 vaccine to 17 year old patient). On 29-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a nurse inadvertently gave a dose of the Moderna COVID19 vaccine to 17 year old patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow-up information contains height, weight, race of the patient added, medical history added. Batch number and anatomical location  of the drug added
8/29/21: Presents to the ED with abdominal pain, vomiting and trembling hands. Diagnosis of: abdominal pain, acute, generalized; acute vomiting; acute appendicitis 8/31/21: Patient was discharged.
Breakthrough case admission after 3 vaccines Moderna 3/12/21 NO Lot#;  Moderna 4/9/21 no lot#;  Pfizer 7/14/22 Lot# FP7139
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On unknown dates, the patients received unspecified doses of ROTATEQ (orally, dose not reported, lot # K013861 with expiration date: 18-MAY-2016) immunization series that were improperly stored. The patients received the vaccinations between 06-NOV-2015 and 10-NOV-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever of 100 F, chills, body aches. Onset was approximately 15 hours post-injection
Had influenza vaccine 4 pneumovax or 10/17/2006 at 11:30am, soreness to arms started 10/17/06. Redness to both arms, 1 3/4 redness to left deltoid arm and 2 3/4" redness to right deltoid area. SX started 10/18/06. Severe headache, hurting down into left ear and jaws bilateral and down into neck. Started today. No relief of symptoms with Tylenol.
doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 2:16 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:16 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 61.92 for dose administered on 20-Mar-2021. No concomitant medications were reported. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature range of 34 to 37 degrees Fahrenheit from 09:00 AM to 10:00 PM. These vials were moved to fridge on 09-Mar-2021 and beyond use date for the vials was reported as 08-Apr-2021. Product moved to clinic on 20-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
Throat tightened (4 hrs) then splitting headache (1 day) and major injection site soreness. Site is still sore and I?m continuing to suffer from fatigue since it started  last week.
No adverse effects; A patient was administered a dose of improperly stored ROTATEQ; This spontaneous report was received from a medical assistant concerning to a patient of unknown age and gender. The patient medical history, concurrent conditions and concomitant medications were not reported.  On 09-JUL-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #R035673  has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent, expiration date reported and establish as 19-SEP-2020, orally, for prophylaxis (strength, dose and frequency were not reported). The temperature of storage and time frame of the excursion were above 47°F (92.3° F) for 3 hours 11 minutes and above 47°F (73°F) for 9 hours. There was a digital data logger involved, but there was no previous temperature excursion.   No adverse effect was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA005362:01266335 US-009507513-1907USA005377:01266338 US-009507513-1907USA005308: US-009507513-1907USA007439:
Erythematous macule below (R) breast scattered varicella-like skin lesions.
Patient had reaction at injection site (pneumonia and flu given on right arm). Patient complaining of area being red, swollen and tight. The patient ran a fever of 103 degrees F over the weekend.
Information has been received from a physician's wife concerning a 64 year old female consumer who on 16-JAN-2008 was vaccinated SQ with 0.65 of zoster vaccine live (Oka/Merck). Three days after she was vaccinated with zoster vaccine live (Oka/Merck), on 19-JAN-2008 the patient developed a water blister on her foot. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report the patient was recovering. There was no product
Vomited 4 times. Sent home from school because he was acting lethargic. He had a temp of 100.4 at 12:30 pm. Laid down on the couch for awhile moaning. Began vomiting around 1:40 pm and threw up 4 times in total.
Hospitalized 01/06/2022-still currently admitted; COVID-19 positive 12/28/2021; fully vaccinated  HISTORY OF PRESENT ILLNESS: Patient is a 86 y.o. female with PMH of CHF, COPD, CKDIII, T2D, CAD, hypertension, hyperlipidemia, OSA, hx of DVT on Eliquis, and main duct intraductal papillary mucinous neoplasm s/p whipple (10/2021) who presents today with shortness of breath.    She was recently hospitalized from 12/30-1/4 for AKI secondary to COVID-19 infection and decreased PO intake. She is vaccinated with two doses of the Moderna, last dose in March 2021. She is now on day 9 of symptomatic COVID infection. Acute on Chronic Hypoxic Respiratory Failure Acute on Chronic Systolic and Diastolic Heart Failure COVID-19 Pneumonia Mild COPD Plan: - Change her oral lasix of 60 mg to 60 mg IV daily - DuoNebs q6h PRN wheezing, SOB - continue home inhalers, transition to Symbicort and Spiriva per hospital formulary for Trelegy - wean oxygen as tolerated - cardiac telemetry - continuous pulse oximetry - Continue her dexamethasone 6mg daily. She has 4 more days remaining in her 10 day course. - Monitor her d-dimer daily x 3 days  01/08/2022 notes: Acute on chronic hypoxic respiratory failure Acute on chronic systolic and diastolic heart failure COVID-19 pneumonia Mild hx of COPD On examination, the patient is short of breath, positive JVD, no wheezing, bilateral pitting edema. Elevated BNP in the ER at 15,654. She was discharged recently with Lasix 40 which she did not take since 1/4. CTA negative for PE. Recently admitted for COVID-19 pneumonia. Was recently discharged on 3L home O2.  Plan: - continue IV Lasix daily 60 - Dexamethasone 6mg daily (three days left to complete 10 days. Will consider transitioning to IV solu-medrol due to worsening respiratroy status in setting of covid infection) - DuoNebs prn - wean oxygen as tolerated 01/12/2022 note: Acute on chronic hypoxic respiratory failure - improving Acute on chronic systolic and diastolic heart failure COVID-19 pneumonia Mild hx of COPD Cough Presented with clinical signs of volume overload and hypoxic respiratory failure.  COVID PCR positive 12/28, recently admitted for COVID-19 pneumonia and was discharged on 3 L home oxygen but was not compliant with Lasix. CTA negative for PE.  Coughing persistent however, wheezing resolved.  Plan: - Oral Lasix 60mg PO held today due to hypokalemia              - replete  With PO K              - will recheck BMP - Dexamethasone 6mg Day 9. - DuoNebs scheduled for 24 hrs - continue inhaler regimen - wean oxygen as tolerated - Protonix BID - PT/OT recommending home with therapy
2:05pm Post vaccination witnessed client pass out for about 30 sec., then becomes conscious responding to verbal  / tactile stimuli w/ full orientation. During transport to medical monitoring witnessed another unconscious episode x 30 sec, noted color pale, skin cool/ clammy, again becomes conscious verbalizing and responding appropriately to questions. Vital assessment: BP 122/44 P85 O2 sat 99%RA; Upon several attempts to sit up during medical monitoring reports increased dizziness,  remains aaox3 at this time. Plan for transport to ER for further evaluation/ treatment, for unresolved vasovagal episodes.
Prevnar 20 administered, was later found that there was a temperature excursion in the fridge where the vaccine was stored. Patient was recommended by provider to return at a later date to receive another dose of the vaccine.
Pt tested positive for COVID after full 2 dose vaccination series.  Presented with symptoms of runny nose/nasal congestion.  Exposed to children who tested positive for COVID.
shingles on face, specifically on eye lid, cheek and neck; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VIRUS VACCINE, LIVE, OKA STRAIN (ZOSTAVAX).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A few months after receiving 1st dose of Shingrix, the patient developed shingles on her face, specifically on her eye lid, cheek and neck. The doctor daignosed it as shingles. No further information was provided.