chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. It was reported that vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Body aches; Injected arm became sore; Chills; Headache; Fever to 101.7 F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PAIN IN EXTREMITY (Injected arm became sore), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever to 101.7 F) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History Information was reported.  Concomitant products included DOXYCYCLINE for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Body aches), PAIN IN EXTREMITY (Injected arm became sore), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever to 101.7 F). At the time of the report, PAIN (Body aches), PAIN IN EXTREMITY (Injected arm became sore), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever to 101.7 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 101.7 f (High) 101.7 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No treatment medications were reported.
Mother reported red slightly elevated area size of tennis ball. Very itchy to child. After injection mother reported allergic Rx to Neomycin when used topically prior to.
R07.9 - Chest pain, unspecified DIZZINESS CHEST PAIN SHORTNESS OF BREATH
Patient received phenobarbital 30 mg elixir at 0042 and flu vaccine at 0041; patient then developed neck swelling and difficulty breathing at 0150. Rapid response called at 0150. Patient complaining of feeling like throat was closing, inspiratory wheezes auscultated. Patient also developed hemoptysis. Patient treated with SOLU-MEDROL IV, PROTONIX IV, and a DUONEB treatment was given. Patient then began throwing up, had a seizure and cardiopulmonary arrest at around 02:30 am. CPR was initiated. After several attempts at intubation, patient was taken to the ICU for intubation due to gross swelling of airway. Patient was intubated with a glidescope and placed on the ventilator. Patient is currently on the ventilator and stable.
Patients were give the dose of the Moderna COVID 19 vaccine that expired; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients were give the dose of the Moderna COVID 19 vaccine that expired) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients were give the dose of the Moderna COVID 19 vaccine that expired). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients were give the dose of the Moderna COVID 19 vaccine that expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. on 10-Sep-2021 vial was initially refrigerated. hadn't undergo any temperature excursions.
pt recv vax JUL95 & 18MAY97 pt devel 12 lesions;21JUN97 lesions were dry;did not have a fever;
The day after vaccination of her second dose of Pfizer, she started to experience numbness in tongue, then two days later, she started to have the left side her face droop including eyebrow and mouth and right eye started to droop with left eye unable to close all the way.
This spontaneous report was received from a back office lead referring to a 35-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 22-FEB-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L035881, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in right deltoid (a dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial information regarding an unsolicited pregnancy valid non-serious case received on 27-Sep-2018 from a nurse. This case involves a 16 years old female patient who was exposed to vaccine MENACTRA while she was pregnant. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant occurred at unknown gestation period. The patient was in her first trimester. The date of last menstrual period was reported as 20-Jul-2018. The estimated due date is 28-Apr-2019. The patient's concomitant medication vaccination included TRUMENBA. The patient had an unknown previous pregnancies. On an unknown date, the patient received a second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5989AA via unknown route in the left deltoid. On an unknown date, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. It was a case of Vaccine exposure during pregnancy. Additionally, at time of reporting, the outcome of the pregnancy is unknown. List of documents held by sender: none.
mild tired feeling in the shoulder/some tiredness at night; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (mild tired feeling in the shoulder/some tiredness at night) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Prostate infection.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (mild tired feeling in the shoulder/some tiredness at night). At the time of the report, FATIGUE (mild tired feeling in the shoulder/some tiredness at night) outcome was unknown. Not Provided          No concomitant product reported by reporter. No treatment medication reported by reporter.    This case was linked (Patient Link).
On April 8, I received my fourth dose of Covid19 vaccine and the second Shingles vaccine. On April 9, I work up sick. I had a fever, freezing cold, aching bones/body and just laid out for three days. I had a sore throat with lesions and felt very fatigued. I checked in with my primary care doctor via email (patient portal) on 04/29 with pictures of my throat. I was referred to an ENT. The ENT doctor believes I am having an auto immune response to the vaccine like mono.
Right deltoid area swollen/erythema 3"x2 1/2 inches RICE, Motrin/Tylenol.
I came down with disseminated herpes zoster. I never had this before.  I have fevers, headaches, disseminated lesions, and body aches.
emesis x2, loose stool x 5-6 over last 2 days. No Fever
Had a flu shot on 11/4/99 and on 11/6/99, noticed bones ached and had a flu-like feeling. Health deteriorated soon after the flu vaccine was administered. On 11/21/99, started to have arm pains in both arms. On 12/15/99, had severe back pains, was treated with a strong medication, which caused the immune system to weaken. On 12/26/00, back pain was gone. On 1/20/00, was hospitalized for 5 days. Back pain lasted 4-5 weeks, but arm pain continued for 5 months. On 6/5/00, came down with a case of shingles, which has gone into post herpetic neuralgia. At this date, still suffering from shingles pain.
Vasovagal syncope after first Pfizer COVID-19 vaccine 0.3 mL IM in left arm.
Per pt. developed the following after vaccination: dry cough, pain in lungs, joints in knee/hip painful, some feet/ankle swelling, feet uncomfortable, "weak" feeling, dr ran xray, blood work, hasn't received results.
2 days after getting the flu vaccination arm started hurting.  She looked at arm and it was black and blue and there was a big lump the size of a tangerine. She went to the doctor and they did an ultrasound to R/O blood clot.  She is fine now but still has a lump but it is smaller the size of a golfball.
Breakthrough case admission after 4 vaccines  Moderna 3/21/21 Lot# 030A21A;  Moderna 4/18/21 lot # 007B21A; M oderna 11/24/21 Lot 939903;  Pfizer 10/6/22 Lot# GJ2524
Starting 16AUG91 devel swollen neck glands & low grade fever 99.2 x last 7 days; c/o feeling tired;
4 hrs p/immun-pallor, duskiness, difficult breathing, limp; breathing improved p/spanking; color returned p/30 mins, nl exam @ that time;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL1283), in left leg, on 05Feb2021 at 09:00 as dose 2, single (Lot number: EL9262), in right arm and on 28Sep2021 at 09:00 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CARVEDILOL (ongoing); LOSARTAN HCTZ (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 07Aug2022 at 06:00, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive, notes: Tested positive for Covid 24Jul22; (07Aug2022) Positive, notes: 7Aug22 symptoms started again and just tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
increased anxiety; increased insomnia; unintentional weight loss/muscle loss; muscle twitching; tremor; skin changed/discoloration; loss of menstrual cycle; numbness throughout entire body; numbness in scalp; systemic burning sensation; tinnitus; tinnitus; This spontaneous case was reported by a pharmacist and describes the occurrence of the first episode of TINNITUS (tinnitus), the second episode of TINNITUS (tinnitus), BURNING SENSATION (systemic burning sensation), SKIN DISCOLOURATION (skin changed/discoloration) and HYPOAESTHESIA (numbness throughout entire body) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (allergy to mango), Allergy to antibiotic (Bacitracin allergy), Allergy (Allergy to lorazepam) and Allergy to antibiotic (voriconazole allergy).   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced the first episode of TINNITUS (tinnitus). On 24-Apr-2021, the patient experienced the second episode of TINNITUS (tinnitus). On 27-Apr-2021, the patient experienced BURNING SENSATION (systemic burning sensation). On 05-May-2021, the patient experienced HYPOAESTHESIA (numbness throughout entire body) and HYPOAESTHESIA (numbness in scalp). On 14-May-2021, the patient experienced MENSTRUATION IRREGULAR (loss of menstrual cycle). On 01-Jun-2021, the patient experienced SKIN DISCOLOURATION (skin changed/discoloration). On an unknown date, the patient experienced ANXIETY (increased anxiety), INSOMNIA (increased insomnia), ABNORMAL LOSS OF WEIGHT (unintentional weight loss/muscle loss), MUSCLE TWITCHING (muscle twitching) and TREMOR (tremor). The patient was treated with CLONAZEPAM (oral) in May 2018 for Anxiety, at a dose of 0.5 mg; PREDNISONE for Burning sensation, at an unspecified dose and frequency and GABAPENTIN for Burning sensation, at a dose of 200-300mg daily. On 14-Aug-2021, MENSTRUATION IRREGULAR (loss of menstrual cycle) outcome was unknown. At the time of the report, last episode of TINNITUS (tinnitus), BURNING SENSATION (systemic burning sensation), SKIN DISCOLOURATION (skin changed/discoloration), HYPOAESTHESIA (numbness in scalp), ANXIETY (increased anxiety), INSOMNIA (increased insomnia), ABNORMAL LOSS OF WEIGHT (unintentional weight loss/muscle loss), MUSCLE TWITCHING (muscle twitching) and TREMOR (tremor) had not resolved and HYPOAESTHESIA (numbness throughout entire body) had resolved. Not Provided     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.   No concomitant medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow up received included: No new information
received Menveo reconstituted with Pfizer Covid diluent; received Menveo reconstituted with Pfizer Covid diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA569A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Menveo lyophilized powder portion after being reconstituted with pfizer covid diluent when the patient was supposed to get the covid pfizer, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No reactions reported. The reporter consented to follow up. This case was linked with 12 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243470:Same reporter US-GLAXOSMITHKLINE-US2021AMR243473:Same reporter US-GLAXOSMITHKLINE-US2021AMR243474:Same reporter US-GLAXOSMITHKLINE-US2021AMR243475:Same reporter US-GLAXOSMITHKLINE-US2021AMR243476:Same reporter US-GLAXOSMITHKLINE-US2021AMR243477:Same reporter US-GLAXOSMITHKLINE-US2021AMR243478:Same reporter US-GLAXOSMITHKLINE-US2021AMR243479:Same reporter US-GLAXOSMITHKLINE-US2021AMR243480:Same reporter US-GLAXOSMITHKLINE-US2021240689:Same reporter US-GLAXOSMITHKLINE-US2021AMR243469:Same reporter
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 30-JAN-2013 the patient was vaccinated with ZOSTAVAX (lot number and expiration date not provided), subcutaneous. On 30-JAN-2013 the patient received less than a full dose ZOSTAVAX because of a syringe leakage. No adverse symptoms were reported. Additional information has been requested.
atrial fibrillation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 2021, outcome "unknown". Clinical course: Reporter stated that he received 3 doses of the Pfizer BioNTech COVID-19 vaccines on 19Jan2021, 05Feb2021 and 06Oct2021 all from Pfizer and mentioned that he had atrial fibrillation and would like to know if he could get another shot of the vaccine. Reporter was over 75.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300315993 Same patient/same product, different dose (dose 3)/event;US-PFIZER INC-202300317384 Same patient/same product, different dose (dose 2)/event;
no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 23-AUG-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
pt devel t102-103 2hr p/vax then low grade temp 101-99 in next 36hr w/APAP given q 4hr;pt whining but eating;afeb on 3rd day but cranky 4th day w/99 on APAP q 4hr;spiked 103 when APAP taken off;adm to hosp
Pt developed urticaria on both arms 4 hours after COVID vaccine administration. Pt received dexamethasone 10mg IM for treatment and diphenhydramine PO 25 mg. Symptoms subsequently resolved.
Pt developed hives to face with some swelling. Pt was taken to clinic and given adrenaline and Benadryl. Observed for 2 hours and sent home with Benadryl for a few days.
Muscle soreness on left arm where vaccine was applied - slight pain when lifting or rotating arm; Muscle soreness on left arm where vaccine was applied - slight pain when lifting or rotating arm; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 at 14:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 14:15, the patient experienced muscle soreness on left arm where vaccine was applied - slight pain when lifting or rotating arm. It was unknown whether therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events muscle soreness on left arm where vaccine was applied - slight pain when lifting or rotating arm was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning his twin teenage daughters who were vaccinated IM with a first 0.5 ml dose of Gardasil.  Subsequently the patients fainted after receiving the vaccination.  Both girls also received their second dose with no reaction.  Medical attention was not sought.  The patients were recovered.  No product quality compliant was involved.  This is one of the multiple reports from the same source.  Additional information has been requested. 02/10/2010 Information has been received from a physician concerning his 17 year old daughter with no allergies who on 05-OCT-2007 at 11:45 was vaccinated with IM witha a first 0.5ml dose of GARDASIL. The patietn fainted after receiving the vaccination. Medical attention was not sought. On 06-OCT-2007 the patient recovered. It was reporte that after the second dose the patient had not reaction. No product quality complaint was involved. It was also requested that the patient and her sibling faint if they receive any injection or lab work. They also faint if they are in the office for an extended period of time. It has been going on their entire life since age 5. If one sister was ill and received treatment or lab work the other sister who was not ill will faint. Their father isa also a fainter. The patient's twin sister also fainted after receiving a dose of GARDASIL (WAES#0712USA08229). Additional information is not expected.
his wife experiencing some pain in her arm; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced some pain in arm on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Severe persistent dizziness, nausea, and vomiting, Taken to Emergency Room on 5/2, diagnosed with BPPV (Vertigo), discharged the same day, Severe dizziness continues for 3 more days, then additional symptoms show up - heavy pressure in the ears and in the back of the head, few days later left ear pops, and the right one clogs even further. On 5/6 visited PCP, no blood nor EKG issues detected, referred to ENT. Visited ENT doctor on 5/12, diagnosed with partial hearing loss in the right ear.
Sterile abscess approx. 2 1/2 x 1 1/2 inches.
5 minutes, post vax, mother was putting child in car seat when she noted infant to be limp and pale. She returned immediately to examining room. Infant was sleepy but arousable, which improved slowly over 30 minutes. Vital signs stable. No localized reaction.