chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a rapid test for COVID, and it was positive; Had a rapid test for COVID, and it was positive; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age started to receive BNT162B2 (lot number unknown), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist stated that they have vaccinated all their caregivers, and a physician (patient) who got the vaccine, called and reported to her that he had a rapid test for COVID, and it was positive. She is wondering if there was any data from the clinical trials where people tested positive after having the vaccine. The patient is now freaking out because he does not know if he needs to go to the hospital and get treatment for COVID. He works night shift and may have been exposed to COVID, but now she does not know how to guide him. The outcome of the events was unknown.  The following information on the batch number has been requested.; Sender's Comments: The reported positive rapid test for COVID after COVID-19 immunization is considered related to the administration of BNT162B2.
Severe sepsis without sepsis shock. ED visit and hospitalization. This visit was within 6 weeks of receiving the COVID vaccine.
golf ball sized rash / very hard borders; hot to touch; skin warm; This case was reported by a pharmacist via call center representative and described the occurrence of rash 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, less than 2 years after receiving Shingrix, the patient experienced rash, heat rash and skin warm. On an unknown date, the outcome of the rash, heat rash and skin warm were unknown.   It was unknown if the reporter considered the rash, heat rash and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, after vaccination with Shingrix, the patient experienced golf ball sized rash hot to touch and very hard borders.
The patient measured her BP the day after vaccination and found it was elevated , SBP 150's. On 12/09/2021 she  started having postmenopausal heavy vaginal bleeding with clots for approximately 2 weeks then decreased to occasional spotting  until 1/20/2022. Her blood pressure  remained elevated for several weeks. On 1/7/2022 the  BP was 156/80.On 1/24/2022 the BP was 124/80
Next day post vax, the pt's left arm was red, swollen, and hot to the touch. Admitted to hospital and received antibiotics by IV.
arm was "a little red"; It itchiness a little; in the arm when got the vaccine, had a kind of rush/It was really big; It burns; It was an intense red color/Really big, 5 or 6 fingers; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was "a little red"), PRURITUS (It itchiness a little), VACCINATION SITE RASH (in the arm when got the vaccine, had a kind of rush/It was really big), VACCINATION SITE PAIN (It burns) and VACCINATION SITE ERYTHEMA (It was an intense red color/Really big, 5 or 6 fingers) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced VACCINATION SITE RASH (in the arm when got the vaccine, had a kind of rush/It was really big), VACCINATION SITE PAIN (It burns) and VACCINATION SITE ERYTHEMA (It was an intense red color/Really big, 5 or 6 fingers). On 06-Oct-2021, the patient experienced ERYTHEMA (arm was "a little red") and PRURITUS (It itchiness a little). At the time of the report, ERYTHEMA (arm was "a little red"), PRURITUS (It itchiness a little), VACCINATION SITE RASH (in the arm when got the vaccine, had a kind of rush/It was really big), VACCINATION SITE PAIN (It burns) and VACCINATION SITE ERYTHEMA (It was an intense red color/Really big, 5 or 6 fingers) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported.  Treatment medication included some body cream. On 06-Oct-2021, the patient left the shower a little red and it itchiness a little then applied some body cream. After that patient came back home at the afternoon, in the arm when got the vaccine patient had a kind of rush it was really big and it burns. It was a very red color really big, 5 or 6 fingers.
PATIENT  REORTED TODAY, 5/3/2016, THAT ON 4/28/16 SHE WOKE UP AND HER LEFT ARM WAS ITCHY. SHE LOOKED AT HER LEFT ARM AND SAW A RASH AROUND THE AREA THAT SHE RECIEVED THE TDAP IMMUNIZATION IN ON 4/26/2016. SHE THEN SAID DURING THE DAY HER ARM SWELLED AND SHE FELT LIKE A GLAND UNDER ARM WAS ALSO SWOLLEN. SHE USED BENADRYL CREAM TO THE RASH AREA WHICH HELPED THE ITCHING AND SHE STARTED ALSO TAKING ORAL BENEDRYL. SHE CONTINUED TO USE BENEDYL SINCE TO PRESENT AND SHE STATES TODAY, 5/3/16, THAT THE AREA IS MUCH BETTER AND THE REDDNESS, SWELLING, AND ITCHING HAD ALMOST FULLY GONE AWAY. SHE STATES THAT SHE HAS NEVER HAD A REACTION LIKE THIS TO TETANUS IN THE PAST.
HEART ISSUES; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; This spontaneous report received via social media from a consumer concerned an adolescent patient of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: Unknown, Expiry: Unknown) dose, frequency one total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, reporter stated that neighbours teen ended up in the hospital (date unspecified) with heart issues after received disease conquering vax and reported inappropriate age at vaccine administration. The number of hospitalized day was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart issues and inappropriate age at vaccine administration was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211047324- Covid-19 vaccine ad26.cov2.s-heart issues. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Swollen Supraclavicular lymph nodes on L side; same side FLU shot administered
Sudden-onset on 5/28 I woke up with signs / symptoms of an upper extremity DVT in my right arm. The arm was colored darker red than my left and my hand felt swollen and tingly, and my right shoulder/ armpit also felt sore.  I went to the ER that day and was diagnosed with an UE DVT in my subclavian vein.  On 5/30 I had surgery called a thrombectomy, in which they went in through a vein in my right upper arm and used tPA & an angiojet to destroy the clot. 3 weeks later at follow-up, ultrasound showed continued vessel damage and it was recommended that I get my first rib resected due to thoracic outlet syndrome, which the surgeon believes this anatomic defect caused vascular damage / impingement of my subclavian v in between the first rib and clavicle.  The rib resection surgery was on 6/23 and took about 2 weeks to recover from. I am still on Eliquis until at least the 3 month mark and am following up with hematology for a hypercoaguable / genetic disorder workup.
Patient received 3 different vaccines. After 5-10,  minutes waiting , patient complained dizziness and short of breath.  I checked the vital signs BP 112/80 HR 90 Temp 35.7 C, oxygen 100% at room temp. Patient given water and stabilized by nurses. Parent given education about HPV. Patient discharged after stabilized.
This spontaneous report was received from a register nurse, concerning an unspecified number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, strength, lot number and lot number were not reported), intramuscular route. Co-suspect and concomitant therapies were not reported. The register nurse reported that an unknown number of patients had received ZOSTAVAX since 19-MAY-2014, that had went through a supported temperature excursion. No adverse effects reported. Additional information has been requested. These case is one (1) of two (2) reports from the same reporter. (MARRS 1405USA015715 and 1406USA000619).
Extreme pain above and below injection site, sore to even have a tshirt on, extreme headache for hours (ibuprofen did help take it away) and metallic taste for hours ? I woke up and everything but the sore arm was gone
After the first dose he had a sore arm for 24 hours; Caller received 1st dose of the Moderna vaccine on 21Mar2021 on his left arm at County Health Department and was unable to receive 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After the first dose he had a sore arm for 24 hours   ) and PRODUCT DOSE OMISSION ISSUE (Caller received 1st dose of the Moderna vaccine on 21Mar2021 on his left arm at County Health Department and was unable to receive 2nd dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010AC1A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM for an unknown indication.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (After the first dose he had a sore arm for 24 hours   ) and PRODUCT DOSE OMISSION ISSUE (Caller received 1st dose of the Moderna vaccine on 21Mar2021 on his left arm at County Health Department and was unable to receive 2nd dose). At the time of the report, PAIN IN EXTREMITY (After the first dose he had a sore arm for 24 hours   ) and PRODUCT DOSE OMISSION ISSUE (Caller received 1st dose of the Moderna vaccine on 21Mar2021 on his left arm at County Health Department and was unable to receive 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
11 hours after vaccine (11:00PM), fever 100.4, muscle aches, joint aches, and more difficulty walking than usual.  Fever broke between 4:00 - 6:15 AM.  Lingering achiness, muscle weakness, but not as bad as when symptoms first started.
Varicella - Information has been received from a registered nurse concerning a 2 year old male patient who on 25 feb 1999 was vaccinated with varicella virus vaccine live on 04 apr 2000 the patient was diagnosed with chickenpox.  The reporter noted that she did not see the patient and that the number of lesions was not documented in the patient's chart.
23 weeks pregnant and received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (23 weeks pregnant and received the vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (1 drink a week) on 20-Sep-2020 and Marijuana use (rare (1 use a month)) on 15-Aug-2020. Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) for Nausea, PRENATAL FORMULA [ASCORBIC ACID;BETACAROTENE;CALCIUM CARBONATE;COLECALCIFEROL;CYANOCOBALAMIN;DL-ALPHA TOCOPHERYL ACETATE;FERROUS FUMARATE;FISH OIL;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE;ZINC OXIDE] for Pregnancy.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 28-Aug-2020 and the estimated date of delivery was 31-May-2021. On 03-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (23 weeks pregnant and received the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (23 weeks pregnant and received the vaccine) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2020, Pregnancy test: positive (Positive) Positive. On 12-Mar-2021, Blood glucose: negative (Negative) negative for gestational diabetes. On 19-Apr-2021, Ultrasound foetal: normal (normal) normal 34 week ultrasound- 29th percentile in weight.         Genetic testing was carried on 09-Sep-2020-Negative Down Syndrome, Edwards  Symdrome, Trisomy 13   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Dose 2, Lab data , Con meds & med history info added.
Low grade fever 98.7; Getting hot and cold chills; Hot and cold sweats; Hot and cold sweats; Feeling kind of weird; Sleeping most of day getting worse; Starting coughing getting worse; Lost all of his energy; This is a spontaneous report from a contactable consumer (patient) reported himself. No, this report was not related to a study or programme. A 55-years-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0198, Expiry Date: Unknown) via an unspecified route, administered in upper left arm on 03Jul2021 (Saturday) at 11:05 (age at the time of vaccination was 55 years old) as a dose 1, single dose for COVID-19 immunization at pharmacy/drug store. Vaccine was not administered at military facility. The patient's relevant medical history (including any illness at time of vaccination) was not reported. He had no family medical history relevant to adverse events. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations were not available). Concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. The patient had no adverse events following prior vaccinations. No additional vaccines were administered on same date of the Pfizer suspect. On 04Jul2021, the patient experienced feeling kind of weird (at 18:00), sleeping most of day getting worse and starting coughing getting worse (in evening). On 06Jul2021 at 04:00, he had low grade fever 98.7 and getting hot and cold chills. On 06Jul2021, he had hot and cold sweats. On an unspecified date in Jul2021, he had lost all of his energy. It was explained that he was okay that night but then he was feeling weird. The next day was 04Jul2021 and he was progressively getting worse. He was sleeping most of the day. He got a cough. Last night the cough got really worse. He felt it in his chest. He wanted to know if he was overreacting. He took his temperature today at 06:00. It was 98.7F. He was feeling hot and cold sweats. He had the chills. He had a call into his physician. He said that he was breathing ok now. He felt as the day went on that the cough got bad. He was totally relaxing and sitting at home. He clarified that the hot and cold sweats and chills went with the fever. He stated that he started feeling weird around 18:00. He felt like he lost all of his energy. The cough started in the evening. His fever started at 04:00 today. He said that he probably wouldn't have gotten the shot. He probably won't go back and get the second one. He stated that his appointment was at 10:45 and he got his shot at 11:05. No treatment was received for adverse events. The patient underwent lab tests and medical procedures which included Body temperature on 06Jul2021, which showed result as 98.7 Fahrenheit. The clinical outcome of the event lost all of his energy was unknown, while the outcome of the remaining events was not recovered at the time of reporting.  Follow-up attempts are completed. No further information is expected.
Fever (103F) chills within 3 of vaccine assessed, following AM. Tx with OTC Tyl prn. Time course: 3 days.
Vaccine administration error: COVID 19 vaccination was given 90 days past removal from deep freeze, which is 20 days past the "beyond-use" date of 2/22/23. No symptoms. No treatment. Decision when to re-vaccinate was made in cooperation with parent of patient.
At site of DTaP noticed red welt on left arm where vaccine was administered about the size of a softball got worse (bigger) the next day, tender, warm to touch, bright red.
Respiratory Distress; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 90-years-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose number unknown (booster), 0.3 ml single (Batch/Lot number: GJ5342, Expiration Date: 18Nov2022) intramuscular for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization.  The following information was reported: RESPIRATORY DISTRESS (death, medically significant) with onset 21Sep2022 at 16:00, outcome "fatal". The patient date of death was 21Sep2022. Reported cause of death: "Respiratory Distress". No autopsy was performed.  Clinical information: About Respiratory Distress: Clarified first patient, 90-years-old old female, passed away at 4pm on 21Sep2022. She went into respiratory distress hours after receiving the vaccine so it was not anaphylaxis related.; Sender's Comments: 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.,Linked Report(s) : US-PFIZER INC-202201182355 same reporter/product/AE, different patient; Report 2 of 2;; Reported Cause(s) of Death: Respiratory Distress.
After my first shot, the next morning, no pain. And, it has NOT come back.; This is a spontaneous report from a contactable consumer or other non hcp. A 67-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration, administered in Arm Right on Mar2021 (at the age of 67-years-old) as dose 1, single for covid-19 immunisation. Medical history included mild osteoarthritis, high blood pressure and wake up with a little joint pain (in the morning, I usually wake up with a little joint pain which takes about 1/2 to 1 hour to go away). The concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 31Mar2021 at 05:00 the patient experienced after my first shot, the next morning, no pain. and, it has not come back. The patient reported that he had an unexpectedly good reaction to the first dose. He had a mild case of osteo-arthritis, so, in the morning, He usually wakes up with a little joint pain which takes about 1/2 to 1 hour to go away. After his first shot, the next morning, no pain. And, it has NOT come back, he had his second dose, and it still has not come back. The joints are still old and stiff, but the pain is gone. The patient wanted to know if he was the only one who has reported this result. The outcome of the event was not resolved. No follow-up attempts are possible; No further information is expected.
SWELLING ABOUT INJECTION SITE ABOUT THE SIZE OF A GOLF BALL AROUND. SLIGHTLY RAISED FROM SURFACE, WARM TO THE TOUCH, RED, TENDER TO THE TOUCH.
This initial spontaneous case, was received from a pharmacist on 11-Oct-2017, concerning a 9-year-old, male child. This refers to 01 out of 04 reports. On 10-Oct 2017, the patient was administered with FLUCELVAX QIV (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch no: 195216 and expiry date: Apr-2018). It was reported that the Influenza vaccine was left out of the refrigerator for a couple of days and temperature had reached maximum of 72F to 90 hours (explicitly considered as incorrect product storage). The same vaccine was administered to the patient (explicitly considered as drug administration error). It was reported that, the patient did not experience any adverse effects after vaccination. The reporter assessed the case as non-serious. Follow-up received from the reporter on 20-Oct-2017: This case was updated from invalid to valid due to reported identifiable age of the individual patients. The patient's age was updated and narrative amended accordingly. Follow-up received from the reporter on 26-Oct-2017: It was reported that, the patient did not experience any adverse effects after vaccination. Narrative amended accordingly. Significant case correction received 20-OCT-2017: The onset date of the event incorrect product storage was removed. The event 'no adverse event' was removed from events tab.
first dose / in 2019 / its been over a year and they haven't yet received dose 2; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAV (Havrix 1440) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix 1440 (receive 1st dose on an unknown date in 2019, batch number 2AD47, expiry date 31th January 2020).   On an unknown date, the patient received the 2nd dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Havrix 1440 as per the vaccination schedule, which led to incomplete course of vaccination. The reporter consented to follow up. This case had been linked with the case US2021151594, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151594:Same reporter
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown age and gender. Medical history and drug reactions or allergies were not specified. On unknown dates, reported as since December 2013, the patients were possibly administered doses of VAQTA injection 25/0.5 (units not reported)(dose, route and lot number were not reported) which were not stored properly. No adverse effects were noted. Concomitant medications were not specified. This is one of several reports received from the same reporter. Additional information has been requested.