chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pfizer-BioNTech COVID-19 Vaccine EUA 72 year old female healthy, not on any medications, came to hospital for her first covid vaccine. After approximately 10 minutes vaccination, she started feeling dizzy, light headed, slightly nauseated. Reports sweating and cold hand. Patient was taken to the emergency department and later admitted to the hospital with new onset afib/aflut with RVR following first dose of Pifzer Covid-19 vaccination. Further workup revealed reduced EF on ECHO and elevated LFTs.  Patient was treated and discharged home.
Arm Swollen at injection site, little itchy today, patient has been tired for 2 days so far.
Patient passed out after receiving the vaccine. Patient was moved to the floor and observed closely and regained consciousness quickly. There were no signs of difficulty breathing, redness, or flushing,  EMS arrived shortly and examined patient. Patient was cleared to drive home. Patient passed out once after getting a vaccine when he was kid but felt he had grown out of it.  He has given blood several times
Within 8 hours of each of 6 doses of Anthrax vaccine, papulofollicular, itchy rash began on buttocks, lasts about a week to 2 weeks, each time. None in interview between shots.
She threw up while taking vaccine, then threw up twice at home, hardly ate at night, and was very sleepy, even when awake she hardly moved, frequent crying all night.
shot was received at Pharmacy   fatigue, soreness in arm, and itching only in right arm which I still have
Vertigo, Blurred Vision, Sweating, Arm Pain, Severe Back Pain, Fainting, Nausea, Auditory Migraine (2 days later).
Site is sore with redness and swelling, Moderate muscle aches, headache, beginnings of a sore throat, jaw stiffness, fatigue, ear ache (only on side that vaccine was administered).
Immediately after injection of influenza vaccine on 11/17/05 patient felt pain at left deltoid site, went up arm toward neck. Patient reports bump at base of neck, left side on 11/18/05, 26 hrs after injection. Taking tylenol for pain, to see doctor 11/23/05
Patient received vaccine on Thursday 11/16/23 and started feeling ill on Friday. She had rash/hives over abdomen and legs beginning Saturday 11/18/23 which she treated with oral loratadine and hydrocortisone cream. Rash had resolved by time of reporting Tuesday 11/21/23.
Approximately 6 hours, post vax, pt started inconsolable crying, fever approximately 100 and bilateral thigh swelling from knees to hips (bilateral) but not just at site of injection. Crying lasted about 6 hours and swelling lasted about 24 hours.
Sudden Sensorineural Hearing Loss (SSHL) in left ear June 2, 2021. Preceded by intermittent brief hearing loss in same ear, for a few minutes at a time, for up to one week prior to June 2.
Very severe brain fog and confusion. Left house at 5 am. Confused, left in Jeep with no one  knowing. No phone, wallet, shoes. Had an accident ( no one else involved) found laying on ground after 11 hours of searching.  Can?t remember what or why it happened, still remains in the hospital at this time.   After his first vaccine he got the brain fog for 1 day, but recovered the next day. No incident due to severe confusion.
I have itchy and swollen hands and feet; I have itchy and swollen hands and feet; I am experiencing a full body rash on face neck trunk legs arm and feet; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (I have itchy and swollen hands and feet), PERIPHERAL SWELLING (I have itchy and swollen hands and feet) and RASH (I am experiencing a full body rash on face neck trunk legs arm and feet) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018F1A, 010M20A and 036A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE (ALYACEN 1/35) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (I have itchy and swollen hands and feet), PERIPHERAL SWELLING (I have itchy and swollen hands and feet) and RASH (I am experiencing a full body rash on face neck trunk legs arm and feet). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (I have itchy and swollen hands and feet) and PERIPHERAL SWELLING (I have itchy and swollen hands and feet) outcome was unknown and RASH (I am experiencing a full body rash on face neck trunk legs arm and feet) had not resolved.
Side effects started the next day. Redness, irritation, pain, swelling, rash.
Patient started with fever (tmax 100.81, chills,  severe headache, and pain at the injection  site on the night of 7/30/2020 which  continue to 7/31/2020
bloody tongue; throwing up/puking; tongue burning two days later bloody tongue; chills; legs shaky; intense migraine; nauseous stomach; I have not been this sick; This is a spontaneous report from a contactable other HCP (patient). A 40-year-old female patient received the first dose of BNT162B2, Lot number: Ek5730, intramuscular on an unspecified date at single dose in the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. On 24Dec2020 03:00, the patient experienced intense migraine and nauseous stomach. On 24Dec2020 07:00, she started throwing up, chills, legs shaky and her symptoms had lasted from Christmas Eve until 29Dec2020. On 27Dec2020, patient's tongue was burning and two days later she had a bloody tongue.  She stated, "I have not been this sick as far as I can remember it was awful. I am a healthy person I get the flu shot and any vaccine/shot necessary and have never been sick like this". Since the vaccination, the patient had been tested for COVID-19. She had a nasal swab and SARS cov 2 RNA for which she had a negative result on 29Dec2020. Stated that the test came back negative so these reactions had to be her body fighting off the vaccine. She stated she is no longer puking, no longer shaky or chills but faithfully at 3 am she woke up and had an intense migraine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any treatment for the events. The outcome of the events "chills", "legs shaky" and "throwing up/puking" was recovered on 29Dec2020. The outcome of the other events was recovering.
This spontaneous report as received from a nurse practitioner refers to a male patient of unknown age. There was no information about the patient's pertinent medical history, drug reaction or allergies reported. On 21-JUL-2016, the patient received the first dose of GARDASIL (dose, site and route of administration, expiry date and lot# were not reported). The second dose of GARDASIL was administered on 21-SEP-2016 (dose, site and route of administration, expiry date and lot# were not reported). On 13-OCT-2016, the patient was vaccinated with the third dose of GARDASIL lot # M014929, expiry date 27-MAY-2017 (dose, site and route of administration were not reported) earlier than the recommended schedule. No adverse effects were reported. Additional information has been requested.
Malaise, myalgias, mild elevation of temperature, fatigue. Unable to do regular activities. Tylenol helped. Spent the following day on the couch. Mild soreness right arm, moderate to severe pain left upper arm (could not raise my arm beyond 20 degrees without increased pain; could not abduct my upper arm to 90 degrees). Still cannot sleep on left side for at least 3 nights.
SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; A RINGING IN EAR WITH A HIGH PITCH SOUND; FELT WHEEZY FOR ABOUT 15 SECONDS AFTER RECEIVING THE VACCINE; This spontaneous report received from a patient concerned a 60 year old male with unspecified ethnicity.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 16-FEB-2022) dose was not reported, 1 total administered on 08-APR-2021 to left arm for prophylactic vaccination. Age at time of vaccination 60 years old. No concomitant medications were reported.  On 08-APR-2021, after receiving the vaccine the patient felt wheezy for 15 seconds when he was about to drive and then it went away and he didn't have any other problems. On 09-APR-2021 morning after he received his vaccine, he heard about it causing blood clots. On 30-JUN-2022, he had a ringing in his ear with a high pitch sound for which he had to wear an ear plug. On 04-JUL-2022, he woke up with headache/sinus headache, he felt sick and had a scratchy/ itchy throat. On an unspecified date, he tested positive with an at home test which indicated suspected covid-19 infection and suspected clinical vaccination failure. Laboratory data (dates unspecified) included: SARS-CoV-2 test (severe acute respiratory syndrome coronavirus-2) Positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt wheezy for about 15 seconds after receiving the vaccine on 08-APR-2021, and the outcome of a ringing in ear with a high pitch sound, suspected clinical vaccine failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000241331.; Sender's Comments: V0: 20220713404-covid-19 vaccine ad26.cov2.s-suspected clinical vaccine failure. 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. Therefore, this event(s) is considered not related.
positive antigen test; positive antigen test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 01Mar2021 at 10:00 as dose 1, single (Lot number: EN6198), in left arm, on 30Mar2021 at 10:00 as dose 2, single (Lot number: ER8732), in left arm and on 05Nov2021 at 10:00 as dose 3 (booster), single (Lot number: EW0183) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 21Apr2022 at 10:00 as dose 4 (booster), single (Lot number: 084J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing), notes: Vaccine dose brand: MODERNA, Dose Number: 4. Concomitant medication(s) included: LOSARTAN HCTZ; ATORVASTATIN.  The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown" and all described as "positive antigen test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive; (19May2022) Positive; (09May2022) Negative, notes: Consecutive negative tests from 9May to 15May; (10May2022) Negative; (11May2022) Negative; (12May2022) Negative; (13May2022) Negative; (14May2022) Negative; (15May2022) Negative; (15May2022) Negative, notes: negative molecule test ('detect hub'). Therapeutic measures were taken as a result of covid-19.  Clinical Course: Seriousness criteria-Results in death was not reported as no. Seriousness criteria-Life threatening was reported as no. Seriousness criteria-Caused/prolonged hospitalization was reported as no. Seriousness criteria-Disabling/Incapacitating was reported as no. Seriousness criteria-Congenital anomaly/birth defect was reported as no. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was reported as yes. Did you/the patient previously receive a COVID-19 Vaccine was reported as yes. No Known Allergies.
redness, swelling, warm to touch at both injection sites. (R) upper arm with  3"x3" area of pink, warmth, mild tenderness. (L) upper arm with 3.5"x3" area of pink warmth, mild tenderness. No induration.
My left under is Swollen - Puffy looking like a extra fat - My right underarm is normal - It does not hurt. It is not red or in-f lammed . But when i put my arm straight down against my side i can notice because of it being swollen in that location. I have not reported to my doctor yet.
Pt was given the 0.5ml dose of the 6m-11yr COVID vaccine instead of the 0.25ml dose.
THE VIAL OF VACCINE WAS DILUTED INCORRECTLY.  0.8 ML OF DILUANT WAS USED AND NOT 1.8 ML.  THE PATIENT WAS MONITORED FOR THE REQUIRED 15 MIN POST VACCINE, THE ERROR WAS NOT RECOGNIZED UNTIL AFTER PATIEN HAD LEFT THE OFFICE.
Pt. received her first Pfizer covid 19 vaccination on April 21, 2021. During her well-child visit, she was told that she needed to take the meningococcal vaccination for college requirements. In error, the doctor did nor ask if she had received any vaccinations within the last two weeks. They gave her the meningococcal vaccine that day, which was six day after her first covid 19 vaccine. At 10pm on 4/27, she pointed out hives that were erupting on the upper part of her body. Are few minutes later, she pointed out more hives and said she was having difficulty breathing. I gave her Benadryl and drover her to the emergency room. They gave her oral steroids and steroids through an IV. She c Cc on tied to have hives three months afterward.
Chills, headache and fatigue lasted about 12 hours. Heart racing, feeling of heart pounding, not being able to relax and extreme fatigue started on 3rd day after vaccine and lasted about 2-3 weeks.
Headache, Sedation, CoughWheeze, Diarrhea, Sore Throat, congestion, hoarseness Narrative:
From the first shot, fatigue, sore muscles and joints, brain fog.  starts to get better then I have the next Covid shot and it starts all over again
3/3/06 Presented at office with erythematous papular rash over whole body and +80 lesions. RX calamine and Atarax.
PNEUMOVAX-23 vaccine gave him a low grade fever, chills, and body aches.; PNEUMOVAX-23 vaccine gave him a low grade fever, chills, and body aches.; PNEUMOVAX-23 vaccine gave him a low grade fever, chills, and body aches.; This spontaneous report was received from a consumer referring to his father - a 77-year-old male patient. There was no information regarding the patient's pertinent medical history or concomitant medications provided. He had no drug reactions and allergies.  On 12-NOV-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), one time injection (strength, dose, route of administration, lot # and expiration date were not provided), for prophylaxis.  On 14-NOV-2020, the vaccine gave the patient a low grade fever, chills, and body aches. The outcome of pain, pyrexia and chills was reported as recovered/resolved on 16-NOV-2020. The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
Vaccine administered was 2 days expired (expired 11/18/2023  -- date of admin 11/20/2023). No further reactions noted at this time.
constant headache, pain throughout my body, mild temperature (99.3) with chills off and on, restless sleep. Symptoms gradually declined and disappeared within 24 hours.  No reoccurrence.
Vaccine was given to pt. Next day pt developed skin infection due to vaccine. (L) thigh. Med was Rx to pt KEFLEX BID x 7 days, F/U in 2 wks.
Patient reports inflammation and redness in left arm, near immunization area. We call patient to follow up in 2 days and said that is better and the inflammation is improving.
2 " x 4" redness - left thigh. Patient advised to monitor and follow-up if persists or worsens.
Day of shot #2 (3/31/21) I experienced nausea in the first 15 minutes and felt confused while driving.  Nausea passed in 2-3 hours and I felt fine.  The next day I felt tired, foggy brain, and dizzy.  Assumed it was from the shot.  Side effects continued/worsened.  4/6/21 I saw my Dr.  She checked me over, labs. found nothing wrong with me.  Likely side effects from Pfizer.  Unlikely that they would last two weeks.  Rx Meclizine for dizziness, which didn't really help.  Now it's Day 15.  Tired and brain fog are gone.  I don't feel as dizzy.  BUT, when I try to drive, I feel QUITE dizzy with blurred vision.  This side effect persists and clearly effects my quality of life.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium
pt recvd vax; seen in MD's ofc w/ a local inject site react consisting of a rash erythematous & vesicular in nature; swollen deltoid; not tender; afebrile; no tx; referred to dermatologist for exam;
Pain and tightness in chest. Inability to speak during pain. Need to stretch chest and no deep breaths. Could not do anything to tighten chest.   No doctor visit improved in 2 days
Information has been received from a medical assistant concerning unspecified number of patients with unknown age and gender. No current or historical conditions were reported. On an unknown date the patients were vaccinated with GARDASIL (route, dose, lot# and expiration date not reported). The doses of GARDASIL the patient received were improperly stored. No adverse effects were reported. This is one of two reports from the same reporter. The other report is MARRS# 1503USA000932. Additional information has been requested.
First night: fever of 102.7 at 3am, chills, bad dreams, restless sleep, body aches, headaches, general tiredness 3/19: continued low-grade fever around 101, body aches, headaches, took two Tylenol at 4pm for headaches. Nausea and dizziness started that evening and threw up (had eaten very little that day). Continued nausea and vomiting around 10pm. Took two more Tylenol at that time. 3/20: continued tiredness, mild body aches, ate very little  At time of submission, still feel tired, achy, not hungry
stroke; He temporarily was paralyzed on his right side; This is a spontaneous report received from non-contactable reporter(s) (Pharmacist) from a sales representative. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1), for COVID-19 Immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke"; PARALYSIS (medically significant), outcome "unknown", described as "He temporarily was paralyzed on his right side". Clinical course: Pharmacist said that he experienced a stroke after his 2nd Pfizer vaccine. He temporarily was paralyzed on his right side. He was now back working and said he still had some 'remnants' of the stroke. Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events CEREBROVASCULAR ACCIDENT , PARALYSIS  and the vaccine (BNT162B2) 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 to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate."
prolonged palpatations; tachycardia; SOA; sweats; fevers; anxiety; abdominal pain; lymphadenopathy axialla; elevated sed rate  and crp; elevated sed rate  and crp; This is a spontaneous report from a contactable nurse. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration on 05May2021 (at the age of 31-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration, on an unspecified date (at the age of 31-years-old) as dose 1, single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had prolonged palpitations, tachycardia, shortness of air (SOA), sweats ,fevers, anxiety, abdominal pain lymphadenopathy axilla, elevated erythrocyte sedimentation rate and C-reactive protein (CRP) on 06May2021. These events were lasting for 2 to 3 months without other explanation with extensive workup basically a prolonged immune response to the vaccine. These events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient received treatment with beta-blockers for palpitations and tachycardia and had a close monitoring with extensive work ups. This case was considered as serious but not specified. The outcome of the events was recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report refers to a patient of unknown age and gender. The patient's medical history was not reported. On 21-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N015621, expiration date 15-NOV-2018 for prophylaxis (dose, route and site of administration were not reported). The vaccine underwent a temperature excursion of -9 to 8 degrees Celsius for 4 hours and 25 minutes. Other temperature excursions included -14 to -10 degrees Celsius for 1 hour and 15 minutes and -2.8 degrees Celsius for 1 hour and 41 minutes. Digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1802USA002591: US-009507513-1802USA002592.
Redness, knotted area, pain at injection site - started 7/15/10. Pt came in for visit on 7/16/10 with complaints, gave ATARAX prn, Hydrocortisone 1% topical BID, and Prednisone x 5d. Called patient 7-19-10 and states arm is better, no problems.
pt recv flu vax 16OCT96 & hives/tightness in throat;devel 18OCT96 prescribed the following: Medrol dose pack/DPH/Pepcid AC to drink plenty of fluids;t991. po;VS BP 160/84, 92, 16;
Pain in armpit of vaccinated arm. Advised using OTC for discomfort and to follow-up in 3 days sooner if symptoms worsen or new symptoms develop.