chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administration of booster shot from vial punctured past 12 hours; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of booster shot from vial punctured past 12 hours) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia, Prediabetes and Schizoaffective disorder. Concomitant products included INFLUENZA VACCINE (FLUZONE [INFLUENZA VACCINE]) for an unknown indication.    On 23-Nov-2021 at 10:35 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of booster shot from vial punctured past 12 hours). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of booster shot from vial punctured past 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.  HCP stated the vial was received and put in freezer on 5 Nov 2021 then was pulled out of freezer to thaw the day of being punctured at 11:30 AM on 22 Nov 2021. Total amount of time the vial was exposed to room temperature range is from 11:30AM 22 Nov 2021 then overnight and was administered 23 Nov 2021.  Patient had no side effects since the day of vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow-up received which contains primary source, patient demographics On 09-Dec-2021: Follow-up received on 09-DEC-2021 Updated Patient information, and Medical History and concomitant medication.
Information has been received from a certified nurse midwife concerning five or six 18 to 19 year old females, concomitant medications and pertinent medical histories not specified, who were vaccinated (dates unspecified) with the first doses of GARDASIL vaccine (yeast) (Lot #'s, and routes unspecified). It was reported that several weeks after receiving the GARDASIL vaccine (yeast) 5 or 6 patients unfortunately came back with hundreds of genital warts. At first they thought it may be just a chance occurrence not only did the nurse midwife see these , the doctor saw a few of these instances as well. The patients came in and had a pap, the pap smears came back and after that the first dose of GARDASIL vaccine (yeast) was administered, and after that they saw these outbreaks of genital warts come back. "It was so bad that these girls needed laser therapy and sometimes they continued laser therapy and even after that continued laser therapy. The patients still had genital warts." Some continued to receive the second and third dose and some may not, but at least some did finish the doses. Additional information has been requested.
Patient state she woke the next morning at 4am not feeling well. Took her own blood pressure and it was 70's/40's. She was seen in the Emergency Department for hypotension and tachycardia. She spent several hours in the ER, had labwork and other testing, was discharged feeling better.
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported.     On an unknown date, the patients were vaccinated with an improperly stored doses of VARIVAX (lot # N008077, expiration date 09-MAR-2019) (dose and route were not reported) for prophylaxis. Concomitant therapies included sterile diluent. The vaccine was exposed from -14 degree Celsius (°C) to -10 degree Celsius (°C) for 4 hours and 45 minutes. There was previous temperature excursion from -9°C to 8°C for 6 hours and 26 minutes. The call was made because there was a "data logger". No adverse effects reported. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1709USA008769:
Patient stated that her arm hurt and 2 days later felt feverish, tired, and headache.
Well I had a sore throat that started on Sunday September 5th 2021 around 4PM. Later that night, I had a fever of 101. Very sore throat, fever lasting for two days and the sore throat has lasted several weeks. I went to the DR on 9/7/2021. I was given antibiotics by the DR, a two week course. I completed that but it didn't really make much of a difference. About a week after the medicine, I was still experiencing soreness in my throat and post nasal drip and congestion as well. It took me several weeks in order to clear that illness.
Diarrhea for about 2-3 days after COVID vaccine, was not sure if related to vaccine or medications; Shortness of breath; still gets out of breath; This is a spontaneous report based on the information received by Pfizer from United Therapeutics (Manufacturer Report Number: UNT-2021-002485) via a contactable consumer (patient, self-reported). A 85-years-old male patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization, treprostinil sodium (TYVASO, Inhalation gas), via an unspecified route of administration on an unspecified date and on 24Nov2020, for secondary pulmonary arterial hypertension, TADALAFIL and macitentan (OPSUMIT) for drug use for unknown indication. The patient's medical history included secondary pulmonary arterial hypertension. Concomitant medications were not reported. On an unspecified date, the patient experienced diarrhea for about 2-3 days after COVID vaccine, was not sure if related to vaccine or medications and shortness of breath; still gets out of breath. Tadalafil and Opsumit was not reported for the events of diarrhoea and dyspnoea. The patient reported that he had a little improvement, but he still got out of breath (dyspnoea previously reported). The reporter did not provide causality for the events of diarrhoea and dyspnoea. At the time of reporting, the outcome of the event shortness of breath; still gets out of breath was not recovered and for another event, it was unknown.  Information about lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Experienced a bit ear ringing the 2nd day?s morning after the shot, but it dissolved quickly.  8 days later I experienced continuous mild ear ringing until the date of this report. Other symptoms include sporadic dry/sore eyes and fatigue.  I have sporadic mild nasal congestion too, but it happens even before the vaccine. My major concern is the tinnitus.  Fluticasone nasal spray and cetirizine hcl 10 were used for treatment. After 3 days of this treatment, tinnitus and sporadic dry/sore eyes have not gone away. PCR covid test shows the virus is not detected.  It does not feel like a normal cold and I usually do not have seasonal allergies.
Pfizer monovalent vaccine was administered instead of Pfizer bivalent vaccine. Wrong vaccine administered.
Adminstration Error : COVID-19 vaccine (IM)  given ~ 1/2 inch from the top of the left shoulder in medial area.
Rash appeared 7/19, spreading. Fever. Irritable bright confluent erythematous rash on face and trunk and extremities but not palms and soles, maculopapular.
Widespread rash, difficulty breathing, tightness in chest, swelling at site of injection, tenderness at site of injection.
Pt. states after receiving the 1st dose of J&J 06/24/2021, started experiencing symptoms 07/16/2021 of pain in the left of the head, Primary visit  07/202/2021 and diagnosed with active Shingles on the left side of the head. Treated with Tylenol for pain, recommend of anti-viral drug. Still continuing to develop.
Became very ill during the night (after vaccine) with headache, fever, malaise, chills, sore site. Took maximum dose of TYLENOL arthritis formula symptoms lasting over a couple days.
Fever, chills, cough and headache for 8 days. Hospitalization for dehydration/vasovagal syncope.
Patient received one dose of Pfizer COVID-19 vaccine on 3/24/21, but became ill with a non-COVID infection prior to receiving the second dose. She attempted to waited until her antibiotic course was completed before attempting to reschedule her second dose but became ill with COVID-19 before receiving dose 2. She became ill with COVID-19 symptoms on approximately 5/10/21 and felt ill enough to require an ED visit on 5/24/21. From there she was admitted to the hospital for 3 days with discharge on 5/27/21. She received dexamethasone, tocilizumab, and supplementary oxygen during admission. Patient was discharged with dexamethasone and supplemental oxygen (2L). The patient returned to ED on 5/28/21 stating she is having increased O2 requirements and is unable to care for herself at home. Patient is being admitted and continued on supplementary O2 and dexamethasone.
Per Client description:  Had low grade temperature evening of 9/19/2014.  A.M., Saturday 9/20/2014 awoke to pain in left jaw area, "severe clenching of teeth, & spasms. The clenching of teeth continued through 9/21/14, jaw pain continues through today 9/24/14. Visited dentist 9/22/14, client indicated cracked filling or crown from severe teeth clenching.  Had visited dentist one week before and no problems had been noted.  No other treatment thus far. Advised to call MD and report s/s.
This spontaneous report as received from a health professional refers to unspecified patient of unknown age and gender. No medical history and concurrent conditions were reported. The reporter reported that on an unknown date, unknown number of patients were administered GARDASIL (unspecified dose and route) lot # J010668, expiry date 29-APR-2016 and lot # K007264 expiry date 02-MAR-2017. On an unspecified date the vaccine had been improperly stored. No adverse effects were reported. There was no product quality complaints (PQC) involved. The outcome of the event was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent condition, concomitant therapies or medical history provided. On 09-May-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route were not reported, lot # L011528, expiration date 30-APR-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of the several reports received from the same source. Additional information has been requested.
Patient had rash on his hands, feet, knees, and elbows. Dermatologist stated "multiple polymorphous and target-like erythematous patches and plaques distributed on the leg, hand, arm and feet."
103.3 Fever for 2-3 straight nights Asthmatic flair up Needed to be treated with prednisone and levalbuterol 0.63 mg via nebulizer
This case was reported by a consumer via call center representative and described the occurrence of erythema urticarial in a 74-year-old male patient who received SHINGRIX for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, 7 days after receiving SHINGRIX, the patient experienced erythema urticarial, pain, burning sensation, swelling and erythema. The patient was treated with prednisone. On an unknown date, the outcome of the erythema urticarial, pain, burning sensation, swelling and erythema were not recovered/not resolved. It was unknown if the reporter considered the erythema urticarial, pain, burning sensation, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The caller reports that about 1 week after getting the dose he started getting red welts about the size of a nickle that were painful and felt like they were burning. After about a day or two the swelling would go down and the redness would start going away. The patient saw his doctor and took prednisone for a period of time, but he was eventually taken off prednisone and the welts are still occurring. The patient has never had more than 2 welts at a time. The welts occur on his torso from his naval to his shoulders. Emergency room visit was required.
urticarial/morbilliform erythematous diffuse body exanthem w/pruritis noted on exam on 28AUG92; vax was given on 17AUG92 & recvd Epi;
Mother called nurse 1hr and 48mins after immunizations were given to report child had developed a rash on his face, dry cough, swelling of both ears and eyes. She sated that she had administored Tylenol after the immunizations were given. The child was taken to the local ER for evaluation. Parents refused treatment. Gave oral Benadryl to child when they arrived home from the ER.
Redness, Swelling, tenderness, induration  to left thigh, measuring 12x13cm. Tylenol was prescribed for fever/pain.
red, swollen, and warmth at the injection site; red, swollen, and warmth at the injection site; red, swollen, and warmth at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red, swollen, and warmth at the injection site), VACCINATION SITE SWELLING (red, swollen, and warmth at the injection site) and VACCINATION SITE WARMTH (red, swollen, and warmth at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No medical history was provided by reporter.     On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (red, swollen, and warmth at the injection site), VACCINATION SITE SWELLING (red, swollen, and warmth at the injection site) and VACCINATION SITE WARMTH (red, swollen, and warmth at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red, swollen, and warmth at the injection site), VACCINATION SITE SWELLING (red, swollen, and warmth at the injection site) and VACCINATION SITE WARMTH (red, swollen, and warmth at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. From February 2013 to April 2013, the patients were vaccinated with doses of PROQUAD (merck) (dose and lot # were not reported) that were exposed to multiple excursions and stability information was undetermined. Concomitant therapy was not reported. Doses of PROQUAD (merck) were exposed to temperatures of 12F for 5.5 hours, 11F for 5.5 hours, 10.5F for 5 hours, 11F for 3 hours, 11.5F for 2 hours, 11.5F for 2.5 hours, 11F for 2.5 hours, 11F for 2.5 hours, 10.5F for 2.5 hours, 10.5F for 3 hours, 10.5F for 2.5 hours, 10.5F for 2.5 hours, 10.5F for 3 hours, 10.5F for 3 hours, 10.5F for 2 hours, 11.5F for 2.5 hours, 10.5F for 2.5 hours, 7.5F for 2 hours, 10F for 2.5 hours, 8.5F for 1.5 hours, 9.5F for 1.5 hours, 9.5F for 2 hours, 10F for 1.5 hours, 10F for 2 hours, 10.5F for 2 hours, 10.5F for 2.5 hours, 11.5F for 2.5 hours, 11.5F for 2 hours, 11F for 2 hours, 11.5F for 2.5 hours, 11.5F for 2 hours, 9F for 2 hours, 8F for 1.5 hours, 9F for 2 hours, 9.5F for 1.5 hours, 12F for 1.5 hours, 9F for 2 hours, 11.5F for 2.5 hours, 9.5F for 1.5 hours, 9.5F for 2 hours, 11.5F for 2 hours, 12F for 2 hours, 11.5F for 2 hours, 12.5F for 2 hours, 11.5F for 5 hours, 11.5F for 2 hours, 12.5F for 2 hours, 12.5F for 5 hours, 12F for 5 hours, 11.5F for 2 hours, 11.5F for 4 hours, 11F for 1.5 hours, 10.5F for 2 hours, 15.5F for 3 hours, 9.5F for 2 hours, 10.5F for 2 hours, 11.5F for 3 hours, 12.5F for 2 hours, then 12F for 1.5 hours. No adverse effects were reported. This case is linked to MARRS# 1401USA007112 by the same reporter. Additional information has been requested.
RASH ON FACE WITH REDNESS AROUND THE EYES. WE GIVE PATIENT BENADRYL AND WE KEEP PATIENT FOR 30MIN. WE SEND PATIENT HOME AFTER. NO RASH NOTICED.
atrial fibrillation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: Very limited information regarding this event has been provided at this time. The patient's past history of atrial fibrillation is a confounder.
red, hot injection site; red, hot injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019, the patient received the 1st dose of Shingrix. On 18th April 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site erythema and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced a red, hot, silver dollar sized injection site reaction. The reporter stated that it lasted for 2 to 3 weeks. The reporter did not consent to follow-up. The consumer declined to provide any further details for this adverse event, did not consent to healthcare professional follow up.
Blisters/boils that developed on arm and legs and a few on her torso.
felt pop in right eye; white light flashes; floaters in left eye; blurry vision; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 via an unspecified route of administration, administered in arm right on 05May2021 11:15 (Lot Number: EW0982) as 2nd dose, single for covid-19 immunisation. The patient medical history was none. Concomitant medication included metoprolol succinate ER tablet 25 mg. The patient was not pregnant. The patient previously received first dose of BNT162B2 (lot number EW0153) on 07Apr2021, 11:00 AM in Right arm. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies. No other medical history. Within 24 hours of receiving vaccine on 06May2021 12:00 PM, the patient felt pop in right eye and experiencing white light flashes and floaters in left eye, blurry vision. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received. The outcome of events was not recovered.
Headache, Fever, NauseaVomiting, Fatigue, arm pain Narrative:
low grade fever; red patch around injection site; injection site sore; swollen at injection site; injection site feels hot; Injection site hard; itchy at injection site; hivish at injection site; Felt exhausted and fatigued; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE URTICARIA (hivish at injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included SALBUTAMOL (VENTOLIN [SALBUTAMOL]) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt exhausted and fatigued). On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy at injection site) and VACCINATION SITE URTICARIA (hivish at injection site). On 04-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE ERYTHEMA (red patch around injection site), VACCINATION SITE PAIN (injection site sore) and VACCINATION SITE SWELLING (swollen at injection site). On an unknown date, the patient experienced PYREXIA (low grade fever). The patient was treated with TRIAMCINOLONE ACETONIDE (topical) for Itchy rash, at a dose of 0.1 %; LAVENDER OIL at a dose of 1 dosage form and MELALEUCA ALTERNIFOLIA OIL (TEA TREE) for Itchy rash, at a dose of 1 dosage form. In February 2021, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (injection site feels hot), VACCINATION SITE INDURATION (Injection site hard), VACCINATION SITE PRURITUS (itchy at injection site), FATIGUE (Felt exhausted and fatigued) and VACCINATION SITE ERYTHEMA (red patch around injection site) had resolved, VACCINATION SITE URTICARIA (hivish at injection site) and VACCINATION SITE PAIN (injection site sore) had not resolved. At the time of the report, PYREXIA (low grade fever) and VACCINATION SITE SWELLING (swollen at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consumer stated the events subsided within a few days.   This case was linked to MOD-2021-124421 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up received on 12-May-2021 Added new event.
Severe vomiting 12 hours post 2nd vaccine. Chills, high fever (102.1) for 26 hours. Diarrhea on day 2-4. Stomach ache , loss of appetite for 4 days. Lost 8 lbs. Doctor prescribed zofran.