chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Resident was monitored for 20 min period post vaccine and had no complaints until the 20 minute period had just finished and she had a sudden onset of abdominal pain/epigastric pain that last about 45-60 minutes. She was unable to eat anything and needed to be helped back into bed. Her vital signs were stable (blood pressure slightly elevated) and she has had no complaints or issues since. I do not believe the resident had a bowel movement to coincide with her pain.
Presented to ED c/o covid-like symptoms progressively getting worse.  Admitted for COVID-19 infection w/o resp failure; provided supportive care w/zinc & mag sulfate.
Fluzone trivalent inactivated vaccine given to infant younger than 6 mo. of age.
This medically confirmed health authority report (initial receipt 26-Nov-2013) concerns a male patient. The patient had received flu vaccinations in the past without experiencing symptoms. On the 29-Oct-2013, the patient received AFLURIA (batch number not reported) 0.5 mL via the intramuscular route. On the 08-Nov-2013, the patient developed symptoms of myalgia, a fever that reached 101, runny nose, runny eyes, sore throat which went into the patient's chest and developed a cough. The patient treated the coughing with TYLENOL and saw a physician who recommended a short course of antibiotics. The patient was sick for 2 weeks until 22-Nov-2013.
Pain on injection but 6 hours later could only move shoulder about 15 degrees. after taking motrin and apply cold pak  for an hour pt reported feeling betterpt
The next morning I started  having a burning sensation that has irritated my face and left eye.Since years ago in 1990 got yellow fever vaccine had similar burning sensation in my face and left eye. Also exp pain in my right foot lasting week causing me to slow down in my daily walk. I was concerned about my foot went to see my PCP was told it could be my ligaments. The foot pain has gone since 2nd dose vaccine. I'm still exp symptoms as of 2/5 is still there in my face and left eye.
Full body hives. Skin is red, swollen, itchy in patches. Psychiatrist ruled out Lexipro as cause. Went off Lexipro for one week and hives continued. Hives are present everyday and are relieved by taking Zyrtec. Hives return immediately when Zyrtec wears off.
Rash that started on arms (started on the 9th days after her second vaccination).  Woke up the next day  with rash and facial swelling. Rash itches.   Tried Benadryl on first day.   No soa.  No cough.  No sore throat.  No difficulty breathing.  No vomiting. No new soaps/lotions/hair products or makeup.  Was at amusement park the day it started to break out.   Had also been in the woods in the past few days.
Patient received her flu shot and was fine immediately after administration. A few minutes later, when she was standing with her parents, there was a loud crash and she fell and hit her chin on the floor. Gave a cold compress, she looked pale and was crying. After they left the pharmacy, someone else who saw patient fall said she swayed and had looked dizzy.
Patient received moderna booster and flu shot on 11/05/21. She c/o eye symptoms and preseptal cellulitis related.
pt had no know hlth problems;recv 2mo vax only local rxn of redness, swelling lt thigh which subsided;only sl fever p/inj relieved per mom w/APAP;was found dead 2wk later local daycare;CPR performed;autopsy revealed pt died of SIDS;
2 (TWO) doses of Moderna vaccine today/Double dosing; 2 (TWO) doses of Moderna vaccine today/Double dosing; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (2 (TWO) doses of Moderna vaccine today/Double dosing) and ACCIDENTAL OVERDOSE (2 (TWO) doses of Moderna vaccine today/Double dosing) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (2 (TWO) doses of Moderna vaccine today/Double dosing) and ACCIDENTAL OVERDOSE (2 (TWO) doses of Moderna vaccine today/Double dosing). At the time of the report, EXTRA DOSE ADMINISTERED (2 (TWO) doses of Moderna vaccine today/Double dosing) and ACCIDENTAL OVERDOSE (2 (TWO) doses of Moderna vaccine today/Double dosing) had resolved.            Concomitant product information was not provided.  The patient's mother reported that her son presented for his second dose of the Moderna vaccine and that the pharmacist administered two doses on the same day. The pharmacist stated that the earlier dose had been sitting out too long.  Treatment information was not provided.
Approximately 30 minutes after immunization, donor had itching at site of shot.  Denies all other symptoms.  Resolved within 2 hours of start.  No further problems.
Blisters on hands and arms; This case was reported by a nurse via sales rep and described the occurrence of blister in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 7SK92, expiry date 19th June 2022) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) (batch number J3T44, expiry date 30th June 2021) for prophylaxis.   On 24th September 2020, the patient received the 1st dose of Shingrix and the 1st dose of Fluarix Quadrivalent 2020-2021 season. On 27th September 2020, 3 days after receiving Shingrix and Fluarix Quadrivalent 2020-2021 season, the patient experienced blister. On an unknown date, the outcome of the blister was recovered/resolved.   It was unknown if the reporter considered the blister to be related to Shingrix and Fluarix Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the first dose of Shingrix in right deltoid arm and Fluarix in left deltoid arm on 24th September 2020 and 3 days later experienced the symptoms.  The patient experienced blisters on hands and arms.  The reporter consented to follow up. The case has been linked with US2020199111, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020199111:same reporter
Flu; This case was reported by a consumer via call center representative and described the occurrence of influenza in a male patient who received Rabies NVS (RabAvert) for prophylaxis.   On an unknown date, the patient received RabAvert at an unknown dose. On an unknown date, 4 days after receiving RabAvert, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza to be related to RabAvert.  Additional details were reported as follows: The age at vaccination was not reported.  It was unknown if RabAvert was pre or post exposure. The patient stated he developed and tested positive for flu 4 days after getting the last shot of Rabavert.       Lab Comments: Lab test on an unknown date
Initial unsolicited report received from a nurse on 22-Jun-2018. This case involves a 20-year-old male patient who was vaccinated with a dose of DAPTACEL (batch number, expiration date, dose in series, route and site of administration were not reported) instead of ADACEL (batch number, expiration date, dose in series, route and site of administration were not reported) on an unknown date. The patient's concomitant medications, medical history and previous medications was not reported. The patient had a Laceration of hand on an unknown date. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was not reported whether the patient experienced any adverse reactions following the vaccination. 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 Directive and Module VI of the Practices. 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. List of documents held by sender: none.
Client states he received Moderna first dose on 4/6/21. He states that two weeks after receiving dose client began feeling dizzy and nauseous while driving. Client went to Emergency room and client had tachycardia, Heart rate was ?175 and went up to 200?and stated had a ?temperature of 103.?. Client received Tylenol. Client states he was in emergency room for about 9hrs and was discharged, and stated his symptoms had ?resolved?. He was told at the emergency room that his symptoms were due to a reaction to the vaccine. Client stated he received Dose 2 of Moderna on 5/22/21. Client states he had a similar reaction the second time within 12hrs of receiving Dose 2. Client states symptoms resolved in 2 hrs. and client only rested and didn't seek emergency care. Client hasn't had symptoms since then. Client didn't follow up with his Primary care provider and states he has No allergies or chronic conditions. Moderna booster was not administered and was recommended by RN, per MD recommendation to his primary care provider before getting his booster.
Patient was independent at baseline and then started to feel weak after her Covid-19 vaccines. She started having altered mental status with hallucinations and was brought into hospital.  Patient diagnosed with encephalopathy, sepsis, hypothyroidism, acute kidney injury and needed 2 assist for mobility and daily living. Pt was discharged from the hospital and brought back 10 days later for continued decline in function.
Severe vomiting and diarrhea, started feeling nauseous around 4:30 pm, vomiting started around 6 pm every hour until 11 pm. Diarrhea started shortly after and lasted until 4/4. Fever of 101.67 as well with severe chills during the same time period. Fatigue and weakness lasted with impact to adl's until 4/4
This spontaneous report was received from a pharmacist and refers to a 64-year-old female patient. The patient's historical drugs included acetaminophen (+) hydrocodone bitartrate (NORCO), to which the patient was allergic. The patient did not have any pertinent medical history and did not take any concomitant medications. On 09-OCT-2017, the patient was vaccinated with ZOSTAVAX injection, via subcutaneous route, lot # M036296 with expiration date on 14-NOV-2017 (dose was not reported). The vaccine was reconstituted with sterile diluent (manufacturer, dose, lot # and expiration date were not reported). In October 2017, the patient experienced overall body itching for about a week. The patient did not experience a rash. No laboratory diagnostics were performed. It was unknown if the patient received any treatment. The outcome of overall body itching was reported as not recovered/not resolved. The relatedness between the event and the suspect therapies was not reported.
pt recvd vax NOV95 & NOV95 devel genital herpes simplex;pt stated that she & sexual partner have not had relations w/other people;No further details were provided;
This spontaneous report as received from a Registered Nurse refers to an 18 month old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 07-OCT-2015, the patient was vaccinated with expired dose (third dose in the series) of RECOMBIVAX HB lot # J000722 and expiry date of 17-SEP-2015 (unknown strength and route). No adverse effects were reported. Additional information has been requested.
This is a spontaneous report from a Pfizer-sponsored program. A contactable Consumer reported for a female patient of an unspecified age and race that received PREVNAR 13 for immunization on unknown date at single dose. Medical history and concomitant medciation were unknown. The patient get pneumonia too often. And she was hospitalized during each episode. The outcome was unknown.
P/48 hrs pinpoint rash, temp 102 lasted 2 days; small rash on shoulders; temp 104.8 seen by MD said MMR rxn - spots in throat; severe itching & hysterical;
I developed rash the day of the shot, which went away after 2 days without any treatment. About 6 days after injection, the rash developed again (with itchiness) and for the last 2 days, has become more widespread than the first time. I have taken 1 pill of antihistamine but the rash has not improved.
No additional Ae; HCP calling in to report that an expired dose of VARIVAX was administered on 11/11/2022.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 11-NOV-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (Oka/Merck) subcutaneous injection (VARIVAX) (lot number T037642 has been verified to be a valid lot number, expiry date 06-NOV-2022) (strength, dose, and frequency were not provided) indicated for prophylaxis (expired product administered) indicated as prophylaxis.  No additional adverse events were reported.
This case was reported by a consumer via Communispace "Our Voice" and described the occurrence of sick in a female subject of unspecified age who was vaccinated with Influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. Co-suspect medication included ADVAIR. On an unknown date, the patient started ADVAIR, unknown dosing. On an unspecified date in 2012 the subject received unspecified dose of Influenza vaccine (unknown). At an unknown time after starting Fluticasone propionate+salmeterol xinofoate, and less than one year after vaccination with Influenza vaccine, the subject experienced sick, possible flu virus, possible bronchial infection, sore ribs and cough. The subject reported "I got my shot quite some time ago but know that it is not 100 percent effective. For the last month I've been sick. Don't know if it's the flu or just some form of bronchial infection but it has certainly taken its toll. Been to the doctor twice, ribs are sore from coughing etc., but I know this too shall pass. Got some new medication hoping it's effective. Otherwise, I try to stay away from anyone who seems visibly sick, wash my hands often and am getting plenty of rest and drinking lots of fluids". At the time of reporting the sick, possible flu virus, possible bronchial infection, sore ribs and cough were unresolved.
a bump with fluid, like a chicken pox bump at the site of the shot; a bump with fluid, like a chicken pox bump at the site of the shot; bump broke and fluid came out of it; This is a spontaneous report from a contactable consumer. This contactable consumer (patient) reported that a 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729) at the age of 62-years, via an unspecified route of administration in right shoulder on 12Apr2021 09:30 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient historically received first single dose of BNT162B2 for COVID-19 immunization and had no problems. Patient stated that there was a bump with fluid, like a chicken pox bump at the site of the shot, no other redness. Stated later that night bump broke and fluid came out of it, he put a band-aid on it, it may have a scar later. The events occurred 13Apr2021, no emergency room, no physician office. Outcome of the events was not recovered/not resolved.   No follow-up attempts are needed. No further information is expected.
got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; got COVID within a few days of getting the immunization/five other patients of her own doctor who had that same experience in the same week; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This report is the second of 5 reports.     A patient of unspecified age and gender started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the reporter stated that the patients got covid within a few days of getting the immunization. Also, the reporter assumes that they got it at the testing site because she knows of five other patients of her own doctor who had that same experience in the same week. Outcome of the events was unknown.   Information about Lot/batch number is requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021317500 same reporter, product and event; different patient.
This spontaneous report has been received form a Registered Nurse concerning an unspecified number of patients of unknown age and gender. Concurrent conditions and pertinent medical history were not reported. Some doses of PNEUMOVAX 23, (Lot # L003227,exp. date 13-oCT-2016), (strength, route of administration and dose were not provided), which were exposed to temperatures outside of the recommended range, have been administered to unspecified patients on unspecified dates since 28-AUG-2015. No adverse experience had been reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of painful rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX, the patient experienced painful rash and itchy rash. On an unknown date, the outcome of the painful rash and itchy rash were unknown. It was unknown if the reporter considered the painful rash and itchy rash to be related to SHINGRIX. Additional information received as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The healthcare professional reported that the patient developed a rash on his leg shortly after receiving the dose of SHINGRIX. The rash was about the size of a small plate and was somewhat itchy and painful. This case was reported via webform. No additional details were available.
The day after the J&J vaccine, I experienced a high fever of 102.3, fever-like symptoms, chills, headaches, and fatigue. Symptoms lasted about 48 hours.
Dizziness, Palpitations, Tachycardia,  Lightheaded, Elevated BP for patient 137/100  Narrative:  Patient evaluated and monitored in ED for 75 minutes. No medications administered. Symptoms resolved and patient was dismissed from ED in good condition. Above entry date indicates patient died - the entry was made in error.
Reactivation of Herpetic whitlow distal left index finger.  Original outbreak was in 1975.  Had never had problem until 1/27/2021.
Information has been received from a registered nurse concerning a 16 month old male  with a history of osteomyelitis in the left leg who on 11/18/2005 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot # 646669/0626R). Concomitant vaccination that day included a third dose of Hib conj hepatitis B vaccine (lot 652710/0695R) given IM in the right thigh and a first dose of influenza virus split virion 3v vaccine inactivated (Fluzone) given IM in the left thigh. Illness at the time of vaccination was resolved OM. On 11/30/2005 the patients mother noted a marble size lump at the varicella virus vaccine live  injection site and a  swollen gland in his groin. The child was seen by the physician on 12/02/2005 with induration and redness at the injection site. The patient was treated with cephalexin (Keflex). At the time of the report the patient was recovering. There was no product quality complaint involved. Follow up information indicated that on 11/30/2005 the patient developed a lump at the injection site and swollen lymph node in the right groin without redness. On 12/01/2005 the lump at the injection site was red. On 12/02/2005 the patient had a 1x1 cm area of erythema with papule and 2-3 cm long x 1-2 cm wide induration and inguinal adenopathy. The patient had no temperature and was  treated with Keflex 250 TID x 10 days. No work up was done. On approximately 12/12/2005 the patient recovered. The patients events were considered to be other important medical events (OMIC). No further information is expected.
1wk post vax noticed mildly tender lump @ tip of 5th finger size in axillae x2wk-no problem now on 1AUG97;
G47.30 SLEEP APNEA 12/15/2022 ACUTE CHOLECYSTITIS G47.30 SLEEP APNEA 12/15/2022 ADENOCARCINOMA, PROSTATE G47.30 SLEEP APNEA 12/15/2022 ACUTE CHOLECYSTITIS
Client given 1st dose of Pentacel (ACT-HIB) portion of vaccine mixed with sterile water instead of the Dtap-IPV portion of Pentacel. This would have been her second dose of Dtap-IPV-HIB.  No adverse signs and symptoms noted.  Mother informed of need for client to be re-vaccinated.
Ten days after the injection,the site became red, swollen (approx. 5" across) , hard, hot and very  itchy!  I researched it and have been applying cold compresses and benadryl ointment.  This is day #4 and some improvement.
Pt recvd MMR vax 25JUN90; 2 days later pt devel fever & achiness; Pt recovered from exp;
Initial report was received from a health care professional on 23 November 2012. A male patient of unknown age had received FLUZONE High Dose, lot number unknown (route, site and date of administration not reported) and after an unspecified time had a "severe reaction and is now in the hospital fighting for his life." No further information was available at the time of the report. The patient outcome was not reported. Documents held by sender: none.
No adverse effects; Improperly stored (-8.89 Celsius degree for 1 hour) VARIVAX was administered to the patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history and concurrent conditions were not provided.   On 02-APR-2019, the patient was administered improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number R026547, expiration date 17-SEP-2020; strength, dose and frequency were not reported) was subcutaneously for prophylaxis with properly stored sterile diluent (no lot information was provided). The administered dose experienced a temperature excursion of -8.89 degree Celsius for 1 hour which were detected by a data logger. No previous excursions were reported. No adverse effects was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA005132: US-009507513-1904USA005131: US-009507513-1904USA005130: US-009507513-1904USA004258: US-009507513-1904USA005129: US-009507513-1904USA005630: US-009507513-1904USA005629: US-009507513-1904USA005628: US-009507513-1904USA005631: US-009507513-1904USA005133:
Discrete rash - papules - all over torso vesicular itchy rash, approximately 50 spots, from spots in scalp, one on face, increased spots at groin and torso.
Nausea, body aches; chills; fever after administration (within 12 hours).