chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Consent received by family.  Resident stable at time of vaccination. Resident administered 0.5 mL of J&J vaccine per order. Resident passed away this date at 10:20 am.
5 to 7 minutes after giving pt immunization, he fainted and hit head on tile floor. Pt felt dizzy. He sat down, drank water, and put ice on forehead. After 15 minutes he was fine.
This spontaneous case reported by a consumer, describes the occurrence of tinnitus (right ear) and ear pain in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 046B21A and 032M20A) for COVID-19 immunization. No medical history reported. On Mar 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 12, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced tinnitus (right ear) and ear pain. At the time of the report, tinnitus (right ear) and ear pain outcome: unknown. No concomitant medication or treatment information reported.
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 POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:28 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, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 21.10 for dose administered on 03-Apr-2021  No concomitant and treatment medications were reported. Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit from 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-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 Fisher brand traceable temperature monitor at every hour.   This case was linked to MOD-2022-566976 (Patient Link).
Fever started 11/7/02. Rash on abdomen, back and legs.
This spontaneous report as received from a consumer refers to his wife a patient of unknown age. On unspecified date, the patient was vaccinated with ZOSTAVAX (dose, route and lot # not reported). Concomitant therapy included valacyclovir 1 g daily. The consumer, stated that on unspecified date he and his wife received ZOSTAVAX while he was taking Valacyclovir 1 g daily, and he did not experienced any type of injection site reaction like his wife did. The consumer reported that his wife got the shot and had a normal live virus reaction. But on unspecified date, his wife developed a 100 mm hot spot with mild swelling, also experienced a little bit of pain. At the time of the report the patient was fine. Additional information is not expected.
Narrative:  Patient reports pain in arm, chills, and fatigue for 1 day after vaccination. Symptom has resolved today.  Other Relevant Hx: Symptoms:  & injection site reaction, fatigue, chills Treatment:
Chills, shaking, upset stomach, throwing up, muscle pain/aches, headache
Kid's father statement- Friday night (36 hrs after vaccination) his cheeks seemed red and shiny.  Saturday morning (48 hrs) he still seemed to show more red in his nose and cheeks than normal.  His cheeks appeared better by Sunday (72 hrs) morning; however, his top/bottom eyelids seemed a little red for the next day or so.  He seemed especially irritable on Saturday, but maintained generally regular sleep and eating patterns.  We observed no localized swelling/irritation around the thigh injection site at any time.   All seemed resolved by Tuesday morning
Pericarditis; This is a spontaneous report from a contactable physician. A 75-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date unknown), via an unspecified route of administration, on 12Mar2021 at the age of 75 years old as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. There were no allergies to medications, food, or other products. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. On 15Mar2021, the patient had experienced pericarditis. Treatment drug NSAIDs colchicine was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of the event was recovering.   Follow-up activities closed as no follow-up attempts required.; Sender's Comments: Based on the close temporal relationship, A possible contributory role of the suspect product to the development of Pericarditis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concomitant therapies or concurrent conditions were not reported. On 09-AUG-2016, the patient was vaccinated with ZOSTAVAX (dose, lot number, administration route and expiration date were not provided), "a few hours" after the vaccine was reconstituted (outside of the prescribing information recommendations). No adverse events were reported. Additional information is not expected as there was no consent to contact the physician.
24 hours after injection (L) deltoid edema & erythema 7 cm 2 & raised & warm.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 4:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 4:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 34.39. Concomitant products were not provided. On 08-Feb-2021, Excursion time was 10 AM and 11 AM, temperature was 29 and 35, total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 02-Feb-2021, vial was moved to clinic on 08-Feb-2021. 3 vials were sent to clinic. Vaccine BUD date was 04-Mar-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Pt came in for a few vaccines. Pt was billed for adult comirnaty, accidentally pulled and gave pediatric dose. Patient has not reported any adverse effects. We have tried to call him to re-immunize with adult dose per cdc recommendation but his phone is not in service
was accidently given a dose of MedQuadfi with no reported adverse event; Initial information received on 30-Mar-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age and gender patient and reporter reported that meningococcal A-C-Y-W135 (T CONJ) vaccine [menquadfi] dose was given to patient accidently with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, solution for injection (lot 49281, expiry date: 23-Sep-2024) via unknown route and strength and in unknown administration site for prophylactic vaccination (immunization).  On an unknown date, patient was accidently given a dose of medquadfi with no reported adverse event (extra dose administered) (latency: same day).  It was also reported that patient had 2 Mentara was accidently given a does of MedQuadfi. 1st 9-9 Any bad advice effect of this Happening ? 9-9-2015 and 2nd was 12-7-2021.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for an 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
pt had vaccine and a few minutes later felt light headed and dizzy BP was 204/108 she was taken to observation area and felt worse blood pressure started to come down. she also noted a metallic taste and smell. pt had not taken  her home BP medication that day. she reports her symptoms in total lasted abour an hour
Information has been received from a nurse via a sales representative concerning an approximately 4 year old male who in 2005 was vaccinated with a first dose of VARIVAX vaccine (Oka/Merck). On approximately 06-OCT-2008, "this week", the patient experienced chickenpox. At the time of reporting, the patient's chickenpox persisted. No additional AE information reported. Follow up information was received from a registered nurse who stated that the mother of a child from a child care center called about this adverse experience. She has no information on child, doctor, or the event. Attempts were being made to verify the existence of an identifiable patient and reporter have been unsuccesful. No further information was available.
Called clinic at 6 P.M. stated numbness, tingling in Rt. foot. Seen in clinic 4/13/11, tingling in both feet. Neuro exam normal. Returned at 3:30pm stating arm very sore, back pain, continued numbness. Sent to Urgent Care.
fever 101 degree; sweating; Chills; whole body aching; muscles in back and chest were hurting so bad; muscles in back and chest were hurting so bad; managed to go back to sleep but woke up every few hours; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm at 10:00 am on 29Mar2021 (at the age of vaccination 33-years-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously had no known allergies. Concomitant medications included Fluoxetine hydrochloride (PROZAC) started on an unknown date for unspecified indication. The patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EL3302) via an unspecified route of administration in the right arm on 08Mar2021 at 09:45 am (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 23:45, the patient experienced sweating with chills, whole body aching, muscles in back and chest were hurting so bad, managed to go back to sleep but woke up every few hours. Followed by next day on 30Mar2021, the patient did not have a fever until around 6:00 AM when measured was 101 degrees. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive any therapeutic measures. The patient underwent body temperature test on 30Mar2021 with result 101degrees. The clinical outcome of the event sweating with chills, whole body aching, muscles in back and chest were hurting so bad, managed to go back to sleep but woke up every few hours and fever was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient stated she was found unresponsive by husband who is a doctor early in the morning of 8/9/2019 and was out for multiple minutes.  When she came to, she stated she had difficulty speaking and hearing all of which returned later to her that day.
tiredness at injection site; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tiredness at injection site) and VACCINATION SITE PAIN (soreness at injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included IBRUTINIB (IMBRUVICA) and GAMMA GLOBULIN for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tiredness at injection site) and VACCINATION SITE PAIN (soreness at injection site). At the time of the report, FATIGUE (tiredness at injection site) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: negative (Negative) doctor reported did not have antibodies.         Treatment information not reported.   This case was linked to MOD-2021-308895 (Patient Link).
Intense arm pain. Redness at sight. Small red patch below injection site, probably about an inch below. Feels like a bruise, but no bruising. Bumps up. Pain from injection site extends into side of neck and upper arm.
Child given incorrect vaccination. Child given a Hepatitis A vaccine instead of a Hepatitis B vaccine. The error found when recording vaccines on child's immunization card. Parents notified and Hepatitis B vaccine administered to child.
HEART RACING; THROAT SWELLING; PAIN WITH MOVEMENT; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included abstains from alcohol, and non-smoker, and other pre-existing medical conditions included patient had no drug allergy. no drug abuse/ illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the subject experienced heart racing. On 10-APR-2021, the subject experienced throat swelling. On 10-APR-2021, the subject experienced pain with movement. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. On 10-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throat swelling, fever, and headache, and had not recovered from heart racing, pain with movement, and fatigue. This report was non-serious.
This case was reported by a consumer and described the occurrence of pain in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, 10 days after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were provided as follows" The age at vaccination was not reported. The speaker told the audience that his son was vaccinated with BEXSERO and 10 to 14 days later experienced pain.
This case was reported by a other health professional via call center representative and described the occurrence of migraine in a adult female patient who received SHINGRIX for prophylaxis.  Co-suspect products included SHINGRIX for prophylaxis. Concurrent medical conditions included migraine headache. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, not applicable after receiving SHINGRIX and less than a year after receiving SHINGRIX, the patient experienced migraine, injection site pain, neck pain, product leaflet instructions confusion and product leaflet instructions confusion. On an unknown date, the outcome of the migraine, injection site pain, neck pain, product leaflet instructions confusion and product leaflet instructions confusion were unknown. It was unknown if the reporter considered the migraine, injection site pain and neck pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The health care professional (HCP) did not have vaccine information. The health care professional (HCP) reported that, their patient received a dose of SHINGRIX at local pharmacy. The reporter was unsure if the patient received correct vaccine or not. Because the patient told reporter that, it was stored incorrectly and administered by intramuscular route. The reporter confused about correct storage of SHINGRIX, thought it was supposed to be frozen and vaccinated subcutaneously like ZOSTAVAX vaccine. The patient had a migraine, neck pain, and injection site soreness with 2nd dose of SHINGRIX. The SHINGRIX vaccine was not administered at reporter's location. The reporter was confused regarding SHINGRIX vaccination and storage information. The reporter did not have further information regarding adverse event.
Fever 101, erythematous macular papular rash on trunk, neck, face, and legs, diarrhea, clear discharge from nose, red enlarged tonsils. most likely attenuated measles. fever lasted 6 days rash lasted 8 days.
This is a spontaneous report from a contactable consumer or other non hcp (patient) from a Pfizer-sponsored program Support. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on 23Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the reporter reported that, received 2nd dose 4 days ago, he was prescribed amoxicillin today for a sinus infection, which is already 3 weeks, asking will it affect the vaccine. The patient received treatment for the event. The outcome for the event was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Patient scheduled 1st dose appointment for Pfizer COVID-19 vaccine. Patient made it through entire appointment stating this was her first dose of the COVID-19 vaccine. After administration of the Pfizer COVID-19 vaccine, patient stated, "Please don't be mad at me but I actually got the J&J vaccine earlier this year. It isn't shown to be as effective against the Delta variant so I wanted to get the Pfizer one." Patient was monitored in waiting area for 15 minutes. Appeared to tolerate vaccine well. No adverse effects noted. Patient did not complain of any signs or symptoms of adverse event.