chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for Covid this weekend; tested positive for Covid this weekend; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date in Feb2021 as DOSE 2, SINGLE, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration in Feb2021, as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Oct2021, patient tested positive for Covid this weekend. Reporter reported that my husband received the Pfizer vaccine (both doses) back in Feb through his work (with held). The patient underwent lab tests and procedures which included Covid-19 test: result positive on an unspecified date on Oct2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Fever; Chills/had a lot of chils; Nauseated; Wiped out; Felt like had Covid-19, patient caught Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Felt like had Covid-19, patient caught Covid-19), PYREXIA (Fever), CHILLS (Chills/had a lot of chils), NAUSEA (Nauseated) and FATIGUE (Wiped out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M1A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2022, the patient experienced COVID-19 (Felt like had Covid-19, patient caught Covid-19). On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills/had a lot of chils), NAUSEA (Nauseated) and FATIGUE (Wiped out). At the time of the report, COVID-19 (Felt like had Covid-19, patient caught Covid-19), PYREXIA (Fever), CHILLS (Chills/had a lot of chils), NAUSEA (Nauseated) and FATIGUE (Wiped out) outcome was unknown.            The patient caught Covid-19 on 29-JUL-2022. Patient could not taste anything. No treatment medications were reported.   This case was linked to MOD-2022-666023, MOD-2022-666026 (Patient Link).
Extremely high fever 104-104.5. This child also has had febrile seizures with high fevers. Also had rash develop on arms.
Partial loss of range of motion and partial weakness in left arm starting 2-3 days after injection.
This patient's mother called, the patient vomited 2 times in 6 hours after his vaccination was given. He was fine within 12 hours.
Pain; Fatigue; Headache; This is a spontaneous report from a contactable other hcp via Pfizer Sales representative  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain, fatigue, headache. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/Batch number cannot be obtained.
Pt recv vax on 12/7/98; on same day pt exp screaming x 5 hr, not taking bottle, pt needed to be held
Client states she received Varicella vaccine on the right upper back of the arm .  She stated that she went in to take a shower at 9:00pm and noted redness, tenderness, and swelling at the site of injection.  The next morning it was an area of redness about 8 inches in length and about 4 inches wide on the upper back portion of her right arm.  There was also a raised area in the middle (Hive-like) 3 inch by 1 inch area. She states it was tender, red, and swollen.  She did not do any comfort measures for it.
pt recv vax 25APR97 & 1wk post vax pt devel a cold & a runny nose which lasted 1wk;2wk p/inj had a fever (100) which lasted 1 day;the next day exp vomiting which also lasted 1 day;
Client presented with CDC shot Record for 1st dose Pfizer on 1/19/21 by "AMR LIZ MMCP", LOT# EC3302. Requesting 2nd dose Pfizer, which was provided to the client in accordance with current CDC/manufacture guidance. Client was at 115 days between doses, in excess of 42 day recommendation.
This spontaneous report was received from a medical assistant regarding a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 08-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # 029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees F for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
third dose of the vaccine; Off-label use; arm pain; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age (Age:91; Unit: Unknown) received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration was not reported), via an unspecified route of administration on an unspecified date as dose 3, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter stated they had a clinic today and gave someone a third dose of the vaccine. He asked if there was any information on this, including any issues that should be looking for. Response received does state the following In a Phase I/II study of COVID-19 mRNA vaccines in adults, different strength doses of COVID-19 mRNA Vaccine BNT162b2 were given. This means that some people in the trials have already received higher doses of a similar vaccine (BNT162b1) than the currently recommended dose. The trial showed that although a stronger dose (100 micrograms) was not harmful, the recipients experienced more local reactions with very painful arms being reported. Participants who received 58 micrograms of COVID-19 mRNA Vaccine in clinical trials did not report an increase in reactogenicity or adverse events. If a person is given more than the recommended dose, they should be monitored and treated for any symptoms as required. They should be reassured that this is not harmful but that they may be more likely to experience pain in their injected arm. The clinical outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Vomiting-after eating x 5 days, drinking Pedialyte. Diarrhea-x 5 days Imodium once yesterday 10/21/13 rash all over body-legs and arms/white now gone, chest and face/red-remains on face. Fever highest 104, no fever since Sunday 10/20/13.
7/2/2022. acute left basal ganglia infarction. Right hemiparesis. Admission to a local Medical Center for evaluation.
Patient came into the pharmacy yesterday (12/29/2020) reporting tingling in the upper arm that started after getting the flu shot. She remembers the tingling started the Friday after getting the shot, 6 days later. She stated she was traveling that week. On 11/21/2020 she got the shingrix vaccine on the same side as the flu shot. She stated that the tingling has increase in frequency since getting the shingrix vaccine. She reported the tingling comes and goes, has increase in frequency, and only occurs in the upper arm.
The patient experienced pain, swelling, fevers, chills and cellulitis in the affected arm starting within 24 hours of the IM Pneumovax in the same arm. The patient is a physician began antibiotics because of streaking on the skin(amoxicillin, then levofloxaxin and finally bactrim).
rash; hives; headache; neck pain; stiffness; sore throat; chills; fever; This is a spontaneous report from a contactable nurse. A 42-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration in Jan2021 at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as no. Other vaccine in four weeks was unknown. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in Dec2020 at single dose for COVID-19 immunization and experienced no adverse events at 42-year-old. It was reported that 21 days later patient received 2nd dose in Jan2021 - within 1-2 hours after injection developed rash (undescribed to reporter) and hives which scattered across both arms and wrists. 3-4 hours after injection developed severe headache and approximately 12 hours later developed neck pain / stiffness- both lasting 3-4 days. Six hours after injection she reported a sore throat. 24 hours after injection temperature rose to 102 with chills, she took paracetamol (TYLENOL) and fever decreased within 8 hours. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included paracetamol (TYLENOL). The outcome of the events was recovered in Jan2021.  Information on the lot/batch number has been requested.
I had the worst headache and I got nausea and vomited and wa knocked out for a whole day. I contacted my doctor and they said if I want to come in but I didn't want go. It went away after 24 hours.
Presented with acute onset chest pain, worse with leaning forward, EKG showed PR depression and ST segment elevation - strongly suspected to have pericarditis based on story and EKG findings. Symptoms improved after initiation of NSAIDs. Discharged home with prescription for ibuprofen.
contracted Covid-19 after getting both shots ofModerna vaccine; fever; headaches; cough; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (contracted Covid-19 after getting both shots ofModerna vaccine), PYREXIA (fever), HEADACHE (headaches) and COUGH (cough) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form(s). On an unknown date, the patient experienced COVID-19 (contracted Covid-19 after getting both shots ofModerna vaccine), PYREXIA (fever), HEADACHE (headaches) and COUGH (cough). At the time of the report, COVID-19 (contracted Covid-19 after getting both shots ofModerna vaccine), PYREXIA (fever), HEADACHE (headaches) and COUGH (cough) outcome was unknown.            No concomitant and treatment information was provided by the reporter
Patient came back to our pharmacy 2 days after administering of flu vaccine and complaint Tuesday her arm was sore. I examined her arm and noted that elbow area was swollen, showed bruising and felt hot.
Recurring fevers, cough, feet and hands swell, tender skin, night sweats; all recurring to present time.
Throat tingling and tight, H/A, Funny taste in mouth. Gave water to drink. Benadryl 25mg liquid po and Tylenol ES 2 po. V/S stable and observation.
Patient got the FLUZONE HD on 10-10-2018 and patient is still experiencing pain in shoulder.
BREAKTHROUGH COVID: FULLY VACCINATED COVID POSITIVE WITH BOOSTER. COVID-19 VIRAL SYNDROME WITH PLEURITIC CHEST PAIN AND SOB. NO HYPOXIA, MONITORED CLINICALLY.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 15-OCT-2015 the patient was vaccinated with improperly RECOMBIVAX HB (lot # L004754, expiry date-10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Immediately following vaccination patient noted a throbbing headache.  This persisted for 24 hours. Was seen and felt to have a migraine.  Appropriate therapy has begun.
cardiac arrhythmia beginning within 1 hour of shot and continuing for 48 hours
Pfizer vaccinated patient x2, last dose 02/05/22 admitted to hospital with COVID related respiratory concerns.  Discharged note below:  "74-year-old male with past medical history of COPD and COVID vaccination x2 without booster who presented to emergency department with shortness of breath on exertion.  Patient presented hypoxic 86% responding well to 2 L oxygen nasal cannula.  Chest x-ray showed patchy infiltrates.  Patient admitted for acute respiratory failure secondary to COVID pneumonia. "  01/04/22 visit to pulmonology, patient able to be taken off of daytime home oxygen (remains needed at night).
This case was reported by a physician via Merck and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with ENGERIX B, (GlaxoSmithKline). In 2006, the subject received an unspecified dose of ENGERIX B (administration site and route unknown, batch number not provided). In 2006, at an unspecified time after vaccination after vaccination with ENGERIX B, the subject experienced injection site reaction. At the time of reporting, the outcome of the event was unspecified.
Shingles due to the vaccination; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  shingles due to the vaccination/herpes zoster.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) via unknown route for prophylaxis of COVID-19 infection.On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced shingles due to the vaccination/herpes zoster..  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   on an unknown date the outcome of shingles due to the vaccination/herpes zoster. due to the vaccination was unknown.
Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 68 years old male patient who experienced nausea and headache, while he received FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was reported. On 25-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported in the left arm. On an unknown date, the patient developed a non-serious nausea following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious headache following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Final diagnosis was headache and nausea. Lab tests not reported. The patient was treated with TYLENOL for Headache and IBUPROFEN for Headache. The patient outcome is reported as Recovered/Resolved on an unknown date for nausea and as Recovered/Resolved on an unknown date for headache.
One day post vax, the pt experienced weakness, pain, lethargy and flu like symptoms. Two days post vax, pt experienced a decrease in physical symptoms, but had severe soreness in the right arm. Pt was treated with ibuprofen. Three days post vax, pt developed a 30cm X 40cm area of redness and swelling on the right upper arm deltoid region.
Information has been received from a nurse concerning a teenage female who on an unspecified date was vaccinated with her second dose of VARIVAX (Merck). On an unspecified date the patient had redness, pruritus and local site reactions. The patient sought unspecified medical attention and was treated with ice pack and comfort measures. On an unspecified date, the patient recovered. This is one of several reports received from the same source. Additional information has been requested.
vaccine was stored in the regular freezer /temperature excursion; it was administered to 18 patients; This is a spontaneous report received from contactable reporter(s) (Other HCP).   A 12 year-old female patient received bnt162b2 (BNT162B2), administration date 13Aug2021 (Lot number: EW0185, Expiration Date: Aug2021) at the age of 12 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 13Aug2021, outcome "unknown", described as "vaccine was stored in the regular freezer /temperature excursion"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 13Aug2021, outcome "unknown", described as "it was administered to 18 patients".  Additional information: Clinical course include Registered nurse on the line calling about the Pfizer COVID-19 Vaccine, there was a temperature excursion. Initially she called Facility and was transferred to Medical Information. Initially she stated she did not think it was administered to patients, but she is calling back and said it was administered. The previous Reportum: EZ7JI0GQ. The vaccine was stored in the regular freezer 26Jul2021 and on 13Aug2021 which was day 18 of it being in the regular freezer it was administered to 18 patients. On 16Aug2021 it was administered to 5 patients, an don 17Aug2021 it was administered to 9 patients. Transfer agent confirmed the reporter did not specify the information regarding the patients. Caller initially confirmed to continue with safety report to report on each patient. This report was regarding patient who received vaccine on 13Aug2021.  No follow-up attempts are possible. No further information is expected.
pt became weak, diaphoretic, extremely pale, BP 102/60, 64-weak, hard to hear or palpate;c/o seeing spots;given Epi-BP 90/50-110/60 remained pale, & cont to see spots;taken to hosp
Large (greater than 20 cm) area of erythema surrounding vaccine site and traveling down to elbow.
rash on my legs, no itching; head is feeling numb, no pain, but something I can not describe but with numbness and it is going down lower on my head; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my legs, no itching) and HYPOAESTHESIA (head is feeling numb, no pain, but something I can not describe but with numbness and it is going down lower on my head) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced RASH (rash on my legs, no itching) and HYPOAESTHESIA (head is feeling numb, no pain, but something I can not describe but with numbness and it is going down lower on my head). At the time of the report, RASH (rash on my legs, no itching) and HYPOAESTHESIA (head is feeling numb, no pain, but something I can not describe but with numbness and it is going down lower on my head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Developed cough, swollen breasts, redness on chest area, swollen throat, chills, heart rate of 120, body aches, runny nose.
This spontaneous prospective pregnancy report as received from a physician refers to an unspecified female patient of unknown age with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated with (Merck) VARIVAX (lot number, expiry date, route and site not reported) on 13-FEB-2013 and then on 25-MAR-2013. There was no concomitant medication. On 25-MAR-2013, a pregnancy test done in the office prior to the administration of the second dose of (Merck) VARIVAX noted that the patient was not pregnant. The patient came back for an office visit on 09-APR-2013 and a pregnancy test was done then as well and it was determined the patient was six weeks pregnant. The LMP was approximately 26-FEB-2013 and EDD 03-DEC-2013. The pregnancy outcome was pending. The outcome of the patient was unknown. Follow up information was received on 24-NOV-2014. All telephone attempts to obtain follow-up information has been unsuccessful. Additional information has been requested.
pt wasn't responsive & very quiet (non-verbal) was taken to hosp 28APR93; was hospitalized until 30APR93; started being verbal 30APR93; was dx prolonged sx; 3MAY93 had grand mal sz & again taken to hosp;
SEVER PAIN FROM BASE OF SKULL TRAVELING DOWN THE SPINAL COLUMN. HEADACHE, MUSCLE WEAKNESS, FATIGUE, DIZZINESS, NAUSEA AND LOW GRADE TEMP OF 99.2
Chills, muscle pain, fever(101.3 at 8/19/22), dizziness, nausea
This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On an unknown date, the patients were vaccinated with an improperly stored dose of (Oka-Merck) PROQUAD lot # L030592 with an expiration date of 12-FEB-2017, lot # L040415 with expiration date of 13-APR-2017 and lot # L044056 with expiration date of 12-FEB-2017 (anatomical route of vaccination and dose number were not provided). No adverse event was reported after vaccination with (Oka-Merck) PROQUAD and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt called 02/08/2021 at 12:00 PM detailing possible adverse reaction to vaccine. Pt received COVID-19 Dose #1 on 02/05/2021 at 4:20 PM through the Health Department. Around 10:50 AM 02/06/2021, pt stated she began to feel lightheaded, and jittery. Pt is a Type II diabetic. Pt took her blood glucose level which was initially 193. Pt waited 10 minutes and retook her blood glucose which was 230. Pt waited 30 minutes and retook her blood glucose which was 174. At 2:40 PM blood glucose was 157. At 5:00 PM blood glucose was 120.
Pfizer-BioNTech COVID-19 Vaccine EUA? Fever of 103.6, tired.
fatigue, moderate headaches,muscle pain,joint pain,chills, nausea,mild fever,injection site pain. This is my first of two Moderna vaccines. These side effects began to happen on the same day of the first shot, being 04/07/2021. On the following day 04/08/2021 the side effects WERE very pronounced. I remained in bed the entire 24 hours. On Friday 04/09/2021, I feel somewhat better with these effects (chills, mild fever) are going away.
Fever, chills, aches and sweating started sunday afternoon, continuing until tuesday morning. None of the symptoms were extreme, no medical help was needed. No treatment was  needed.  The sweating was at night for two nights. Overall, the reaction was very mild.
1FEB97 started w/loose cough afeb;3FEB97 given med x 21 days;