chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Short of breath; Chest pain; Heart above 120s; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received the first dose of bnt162b2 (BNT162B2), intramuscular on 18Dec2020 at 20:00 at a single dose at the left arm in the hospital for covid-19 immunization. Medical history included hypertension. Patient was not pregnant at time of report. The patient previously took excedrin [acetylsalicylic acid;caffeine;paracetamol;salicylamide] and experienced allergies. Concomitant medication included Tejocote root. The patient experienced heart above 120s, short of breath, fatigue, and chest pain, all on 21Dec2020 at 13:00. Patient went to a doctor or other healthcare professional office/clinic visit for the events. The patient received treatment which included Tylenol as needed for the events. Tested for Covid twice since the vaccination; Covid test post vaccination - Nasal Swab on 30Dec2020 and on unknown date, both with negative results. Cardiologist consult was pending. Outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.; Sender's Comments: The 45-year-old female patient had medical history included hypertension, and was on concomitant medication.  The reported events short of breath and chest pain were more likely due to underlying disease, and less likely causally related to first dose of bnt162b2 (BNT162B2).  The case will be reassessed should additional information become available.  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 to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I received the vaccine on 12/18. Sore arm the next day (as expected), but then 2 days later, on 12/21 & 12/22 I was SUPER tired in the afternoon/evening. Seems better 12/23. Felt totally fine otherwise, but definitely had significant fatigue that is not normal for me at all. I still plan to get the 2nd dose as scheduled.
Child presented in office same evening following immunization with splotchy erythema on entire leg, swelling 2 cm & irritability; crying episode (2PM to 2AM).. Treates w/Tempra and cold compresses.  child had a low grade fever of 99 at imm.
17 year old received Moderna vaccine by accident. Patient was, 5 months short of minimum recommended age.
i had a stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jun2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 28May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 45 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Sofa for Allergies, notes: Known allergies. No covid prior to vaccination and not tested post vaccination. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 16Aug2021, outcome "not recovered", described as "i had a stroke". The event "i had a stroke" required emergency room visit.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Received their first dose of Shingrix 2 years ago and never received the second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago prior to the reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Received their first dose of Shingrix 2 years ago and never received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-AUG-2023 The reporter wanted to know if the patient need to restart the two dose series or administer only the 2nd dose. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did consent to follow up.
Patient presented to the ED on 3/6/21. Patient hospitalized on 4/22/21. These visits are within 6 weeks of receiving COVID vaccination.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 as dose 1, single (Batch/Lot number: unknown), on 02Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Over weight" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. It was reported that, on 24May2022, the patient started Paxlovid as a treatment for the event COVID-19, taken till 27May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Since getting the vaccine, I've had itching at the injection site, pain in my arm emitting up to my shoulder, shoulder blade, and chest. The pain has gotten better, but has not completely gone away.
This spontaneous report was received from a Certified Medical Assistant (C.M.A.) regarding an unspecified number of patients of unknown ages and genders. The patients medical history or concurrent conditions were not provided. On an unspecified dates, the patients have been administered with a dose of PNEUMOVAX 23 (dose, route, frequency, lot numbers and expiration dates were not provided), which have been exposed to temperatures outside of the recommended range. No adverse effect has been reported. This is one of several reports from the same source (MARRS #1507USA014064, 1507USA014066, 1507USA014067, 1507USA014068 and 1507USA013244). Additional information has been requested.
Information has been received from a licensed practitioner nurse concerning a 15 year-old patient of unknown age. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on 28-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL injection (lot # K023432, expiration date 18-JUN-2016; dose and route were not reported), which underwent supported temperature excursions. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a medical assistant for the pregnancy registry for GARDASIL, concerning a 22 year old female with no known pertinent medical history or drug reactions/allergies who on 28-MAY-2008 was vaccinated with a first dose of GARDASIL 0.5 ml IM.  Concomitant therapy included ALESSE, LEXAPRO, ZOMIG and phentermine.  On 01-JUL-2008 the patient had a blood test that showed she was 5 to 8 weeks gestation.  Her last menstrual period was approximately 27-MAY-2008 and her estimated due date is approximately 03-MAR-2009.  The patient sought medical attention in the office.  Follow-up information was received.  On 10-JUL-2008 the patient underwent elective termination.  Upon internal review the patient's elective termination was considered to be an other important medical event.  Additional information is not expected.
Her pharmacist notified her  3 weeks later that the lot was expired and offered her a re-vaccination; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Her pharmacist notified her  3 weeks later that the lot was expired and offered her a re-vaccination) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Her pharmacist notified her  3 weeks later that the lot was expired and offered her a re-vaccination). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Her pharmacist notified her  3 weeks later that the lot was expired and offered her a re-vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was provided. No treatment medication details was provided.  It was reported that patient received third shot of Moderna COVID  vaccine, the six month booster.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: Added reporter details, start date of suspect product and batch number. On 22-Nov-2021: Follow up received contains no new information.
Spoke to mother of child via telephone about 6:30pm regarding possible vaccine reaction. I advised to ER and that I would follow up Monday with her. She stated the child said his legs hurt and felt tired. I told her it could be nothing serious but to proceed to the ER regardless, she said she would.
Patient received shot Wednesday morning, started getting pain in arm a few hours later. Patient says no rash or swelling, but has bad pain. It gets worse if he moves his arm. Pain hasn't gone away or gotten better (now Monday).
mucocutaneous disorder NEC; MD thinks it a viral thing; possibly mono; screaming every time she had to pee; so painful; open ulcer/lesions in the vagina with severe burning; couldn't sleep; pain was effecting the nervous system; no energy; sore arm after the shot with ache and pain; A spontaneous report was received from a consumer concerning a 22 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm after the shot with mucocutaneous disorder NEC.  The patient's medical history was not provided. Recent (Aug 2020) STD profile  was clear and not having unprotected sex.   Concomitant medication included anti muscle relaxer and antidepressants.  On 02 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 02 Mar 2021, the patient immediately experienced sore arm after the shot. On 03 Mar 2021, the patient developed rash on the face and in the mouth and vaginal area and was painful, feeling week, unable to sleep and had painful urination. The patient visited GP, urgent care, ER and dermatology consult who cold not come to an exact diagnosis and suspected a vial infection. The herpes test was negative. She was treated symptomatic locally with lidocaine for vaginal lesions, and generally with anti viral drug, tylenol, Ibuprofen, morphine and oxycontin. She stayed overnight in the hospital and was discharged on 08 Mar 2021.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events secondary to rash were considered as resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Headache, Myalgia, Diarrhea, Lethargic, limited movement of (Dead) left arm, congestion Narrative:
severe allergic reaction; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer Sales Representative. A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on an unspecified date (Lot number and Expiry date was not reported) as dose number unknown, single for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced severe allergic reaction after receiving the Pfizer-Biontech Covid19 vaccine. The patient visited the ER due to the event. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient reported experiencing neck stiffness, injection site redness that appeared to be slightly spreading and the injection site was hot to touch. He was advised to report any worsening symptoms and should make his doctor aware.
This infant had diarrhea,and vomiting after receiving DTaP, Polio, Prevnar, HIB, and HBV on 03/08/01. He was admitted to the hospital 03/09/01. Elevated potassium, low blood sugar, and swollen liver.
Patient had increased frequency of seizures (6 in the same day of vaccination), treated with Clorazepate bridge
This spontaneous report was received from a physician, via company representative, referring to a male child of unknown age. Information regarding the patient's medical history, concurrent conditions or concomitant medications was unknown. On an unknown date, the patient was vaccinated with GARDASIL 9, intramuscularly as prevention of human papillomavirus (HPV) (dose, anatomical location, lot number and expiration date were not reported). On an unknown date, after receiving GARDASIL 9 the patient experienced seizures. Furthermore, the patient visited the neurologist and received treatment to the aforementioned event. It was unknown if any laboratory diagnostic was performed. At the time of the report, the outcome of seizure was unknown. The reporter did not provide causality assessment between the event and vaccination with GARDASIL 9.  Upon internal review, the event seizures was determined to be medically significant. This is one of two cases from the same source.; Sender's Comments: US-009507513-1809USA008294:
recieved their 1st dose of Twinrix in April 13th 2018 and 2nd dose in June 3rd 2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 13th April 2018).   On 03-JUN-2023, the patient received the 2nd dose of Twinrix. On 03-JUN-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: recieved their 1st dose of Twinrix in April 13th 2018 and 2nd dose in June 3rd 2023.). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 2-Aug-2023 The pharmacist had 2 patients. The reporter was in a hurry to provide any other details. The reporter consented to follow-up. This is 2 of 2 linked patients reported by the same reporter for different patient. The patient received second dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.; Sender's Comments:  US-GSK-US2023105225:Same reporter, 2nd patient
CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional concerned a 56 year old male of an unspecified race and ethnic origin. The patient's height and weight were not reported. The patient's past medical history included thymoma (removed 5 years ago followed by radiation treatment) and concurrent conditions included he had recurrent pneumonia (not related to covid but related to the thymoma), non-alcohol user, non-smoker, left lung disfunction, nerve damage on the left side (related to the thymoma) and other pre-existing medical conditions included he had no known allergies.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: unknown) dose was not reported, 1 total administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On AUG-2021, the patient had confirmed covid-19 infection and confirmed clinical vaccination failure. On 12-AUG-2021 he was hospitalized for Covid. The number of days hospitalized was not reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0-20210829316-COVID-19 Vaccine AD26.COV2.S-Confirmed Covid-19 Infection, Confirmed Clinical Vaccination Failure- This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
pt w/lyme disease in1998 recv vax 30MAR99;31MAR99 pt exp 2 complex simple sx & one grand mal sz;The nurse from the treating MD ofc confirmed pt exp a sz less than 24hr post vax;pt taken to hosp by amb & tx w/ valium;pt exhausted & dejected;
Death on May 21, 2022. Patient, was a scientist/professor, an active and healthy man.  To avoid covid, he had two Moderna vaccines and one booster shot from Pfizer. The Vaccination dates were as follows: Two two Moderna vaccines: The date:June 21,2021 , lot #:025C21A The second vaccine shot was on The Date: July 19,2021 , lot #: 045B21A The third booster is Pfizer.  The date: March 31,2022 , the lot #?FK9896  After the booster shot, two days later on April 2nd 2022, patient traveled from place to place for a business trip. On April 8 he started to feel an upset stomach. It was difficult to keep down food and water. He felt so tired and weak throughout his stay in country. He developed a bloated stomach.  On April 28, he returned home from country, extremely jaundiced. On April 29, he went to health center to check up and had a blood test. The diagnosis showed he had high levels of bilirubin and something was triggering his liver dysfunction, though there was not much general cirrhosis. On May 5th evening, he went to Emergency hospital for his stomach bloating and difficulty breathing. On May 11 he was transferred to medical center for liver transplant evaluation. On May 21 2022 he passed away. The main cause was his weakened immune system as he had a fungal lung infections with the underlying sudden liver failure.
Woke in the night (@ 1:30 am) with stomach pain, dehydration and blurred vision.  Vomited several times through the night.  Also had severe diarrhea.
High fever (104.7) and brief seizure 3/24/07, 8 days after vaccines given. CBC, urine normal. Exam normal.
This spontaneous report was received from a pharmacist refers to a 56 year old female patient. Medical history was not reported. On 28-OCT-2014 the patient was vaccinated with the second dose of ZOSTAVAX vial, 0.65 ml, subcutaneous, lot # K009772, expiration date: 09-OCT-2015. Concomitant therapy was not reported. The pharmacist informed that on 29-OCT-2014, the patient experienced a raised, red swollen area, about one inch in diameter, at the injection site after receiving ZOSTAVAX. Also informed that the patient had inadvertently received the second does of ZOSTAVAX. It was not known when patient received the first dose of ZOSTAVAX. The patient did not receive treatment for the adverse event. There were not laboratories studies performed. The patient sought medical attention calling the pharmacist. The outcome of the events was unknown. Additional information has been requested.
PAIN; 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 bursitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
COVID-19 symptoms started on 04/18/22. Tested Positive with home test on 04/19/22. Symptoms included runny nose that started towards the end of day, bad sore throat, and a headache. Symptoms lasted through 04/28/22 and by 04/29/22 the test was negative. It lasted 10-11 days. I called my PCP so they would know just incase they reported numbers and there was a question if I should get the antiviral.
I was extremely itchy for 7 days, exactly. I tried taking allergy medication to relive the itching, which kind of worked, but ultimately my skin felt so irritated that I had to remove all of my clothing and lay in the bed and sleep for days, which is a weird remedy, but that was the only thing that relieved my skin irritation. A week to the day of my first dose, I felt completely fine, had no more skin irritation and was essentially back to normal.
vaccination site mass; This case was reported by a pharmacist via other manufacturer and described the occurrence of injection site lump in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown.   It was unknown if the reporter considered the injection site lump to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The pharmacist reported that the patient complained about a lump on the arm after receiving shingrix on unspecified dates. No clarification information was provided, no further information was provided. This is 1 of the 5 patient case linked through same reporter