chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In 2020, I had COVID-19. Ever since then, I have experienced health issues. I have been in and out of the hospital with stomach issues. After receiving my first dose of the Moderna COVID-19 vaccine, I could feel it in my head. After that, I developed some issues in my left foot. I have an involuntary movement in my left foot. The neurologist I've seen thinks it may be due to the medication mirtazapine that I was taking at the time for anxiety. The week after receiving the vaccine, I remember feeling worse than I did before. My stomach issues got worse. My stomach felt like a car engine, like it was just rolling all day long. There was nothing I could do to stop it. I was not having diarrhea and I was eating well, but nothing would stop the movement. I lost weight rapidly. In less than 3 weeks, I went from 155 to 102lbs. I have seen multiple doctors and specialists and have still not been able to diagnose a problem. I was able to put a little bit of the weight back on and am up to 116lbs. I'm seeing an out of state doctor now who informed me that they have seen a lot of patients with stomach issues after having COVID-19. The doctors I've seen seem to believe that there is something keeping my body from absorbing the nutrition from my food, but they don't seem to know what. I am working with a nutritionist who has advised me to take some supplements and my stomach has calmed down a bit, but it is not back to normal.
After my vaccine, I had a psoriasis flare up. My left elbow has quite a flare up psoriasis and it is very itchy and turned into a skin infection I got prescribed antibiotics for a couple of weeks.   I am still treating my conditions with antibiotics.
I am still having pain at injection site. It is usually a dull ache but sometimes sharp and shooting pain with use of arm.
Shakiness, legs feeling like will give out, warm sensation to face.  3/19/2021 continued to note shakiness.  In addition, irregular heart beat.
no adverse event; Incorrect product storage; This spontaneous report was received from the patient's parent referring to a 5-year-old (also reported as 4 (unit not reported)) male patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 13-APR-2021, the patient was vaccinated with incorrect storage varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, route, lot# and expiration date were not provided) for prophylaxis at the private doctor's office (incorrect product storage). The temperature excursion occurred as a result of reading from a Data Logger. No adverse event was reported.
Hives x 12 days, started on day of vaccine. Used triamcinolone. Recommended fexofenadine twice daily until clear. Test for other sources with PCP.
Pulsating muscle back pain; This is a spontaneous report from a contactable consumer (patient).  An 83-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date unknown), via an unspecified route of administration in the right arm on 12Jan2021 at 11:00 AM at  a single dose for COVID-19 immunization.  Medical history included advanced prostate cancer and penicillin allergies. The patient had no COVID prior to vaccination.  Concomitant medications included prednisone, amlodipine, losartan, and enzalutamide (XTANDI) given on unknown dates for unspecified indications. Patient has not had other vaccine in four weeks. On 12Jan2021 at 15:00, the patient  experienced pulsating muscle back pain. The patient has not been tested for COVID post vaccination. Therapeutic measures were taken as a result of the event  which included  unspecified OTC medicine. The outcome of the event was recovering.
Narrative: COVID infection following COVID vaccine series 02/26, Pfizer, dose #1 03/19, Pfizer, dose #2 08/03 pt cc: headache, rhinorrhea, sore throat, myalgias, dyspnea, cough exposure: unknown 08/30 SARS-COV-2 Variant Sequencing result: pending 08/30 COVID swab, result: detected 08/30 BinaxNOW COVID-19 Ag result: not detected
Sore arm (moderate) from 5 min to 36h post dose; mild bumpy rash starting  5 days after dose 1 on backs of both hands and L lower arm, still ongoing. (Not exposed to new allergens except vaccine, never have rashes of duration greater than a few hours.)
Syncope after vaccination given, patient passed out, lost consciousness for about 3 seconds, then spontaneously woke up. Patient was given water to drink and instructed to stay seated for several minutes before leaving with mother. - Mother was called into room immediately.
The pt reports post vaccine she experienced  a pigmentation change around the neck. The pigmentation change spread to the arms, chest, and belly. The pt took steroids for one month with no change.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 21-JUL-2015 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (0.5 ml; lot # lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 1 time. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) was 112, 32, 0 and R. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax;pt got ill with fever of 105; sz; to ER; dx w/ pneumonia in rt lung and earache;
"Dotty" rash, no itching or pain. Axillary node enlargement under left arm where shot administered. Right axillary nodes enlarged about 24 hours later. Had fever 100 degrees for 24 hours and general muscle aches.
Headache, Sedation, Myalgia, Arthralgia, Fever, CoughWheeze, Tachycardia,  flare up lupus erythematosus  Narrative:
This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of adverse event in a subject of unspecified age and gender who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 13 February 2014 the subject received a dose of BOOSTRIX (unknown). Within months of vaccination with BOOSTRIX, the subject experienced adverse event. At the time of reporting the outcome of the event was unspecified. No other information was provided. The lot number was reported as "YJ4575" from the reporter; however, based on a safety lot number review, the lot number was updated to YJ475. Follow up was received from consumer (patient) on 16 May 2014. The patient reported that in February 2014, within a month after vaccination with BOOSTRIX, she experienced injection site nerve damage and injection site reaction (described as "hurt my nerves or bone"), arm pain at injection site (described as "terrible pain in the arm where administered"), injection site movement impairment (described as "range of motion in the arm is still affected" and "cannot move it as freely as the unaffected arm"), fear of injection, vaccine administered at inappropriate site (described as "administered the vaccine incorrectly in wrong place"), and wrong injection technique (described as "technician did something wrong"). At the time of reporting, injection site nerve damage, injection site reaction, arm pain at injection site, and fear of injection were unresolved. At the time of reporting, injection site movement impairment was improved. The patient reported "that she is not certain whether her doctor wants to get involved. She did see her doctor for what she thought was a reaction to the vaccine (terrible pain in the arm where administered, could not move the arm after the shot) and the doctor told her this was not a reaction, the doctor and the patient believe the technician at (the pharmacy) administered the vaccine incorrectly 'in wrong place, hurt my nerves or bone or something.' She still has arm pain since February 2014. She believes the manager of the (pharmacy) reported this to GSK as a problem with the vaccine but the patient reports she is 90 percent certain the pharmacy technician did something wrong. The patient also reports that her range of motion in the arm is still affected, she cannot move it as freely as the unaffected arm. The patient will not use BOOSTRIX in the future because she states she now has a fear of the administration" (fear of injection). The follow up was faxed to legal.
Patient received her second dose of the Moderna vaccine one week early.   There are no known complications for the patient.
Fine red rash on belly and legs developed 2 days after immunizations received. No accompanying fever. Child was not taken to the doctor.
No adverse event; patient received a bivalent Moderna COVID-19 vaccine as their first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID-19 vaccine as their first dose) and NO ADVERSE EVENT (No adverse event) in a 15-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID-19 vaccine as their first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID-19 vaccine as their first dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID-19 vaccine as their first dose).    No concomitant medications was reported. No additional doses and symptoms was reported by patient. No treatment was received by the patient.
Small rash at 2 days after injection at injection site, that grew at 3 days. After 5.5 days, rash was over most of upper arm between elbow and shoulder and was very warm to the touch.
Vomiting and loose stools started on 1/16/19. Seen in office on 1/17/19 trial of zofran for vomiting. Seen in ER on 1/18/19 due to persistent vomiting even after zofran and colicky fussiness episodes. Ultrasound showed intussusception and was reduced. Symptoms resolved. Patient was discharged home on 1/19/19. Follow up done by phone on 1/24/19, mom reported patient back to her normal self. Eating normally.
PFIZER COVID-19 EUA: fully vaccinated patient presented 072921 with a 3-day history of congestion, headache and productive cough
When the general side effects list was read, he said the only thing he did not have was nausea or vomiting/ had symptoms and they went away; Freezing with chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (When the general side effects list was read, he said the only thing he did not have was nausea or vomiting/ had symptoms and they went away) and CHILLS (Freezing with chills) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 93H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced CHILLS (Freezing with chills). On an unknown date, the patient experienced VACCINATION COMPLICATION (When the general side effects list was read, he said the only thing he did not have was nausea or vomiting/ had symptoms and they went away). At the time of the report, VACCINATION COMPLICATION (When the general side effects list was read, he said the only thing he did not have was nausea or vomiting/ had symptoms and they went away) and CHILLS (Freezing with chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant product use was reported.  The patient had symptoms and they went away but on 10-Jan-2022, the patient woke up freezing with chills. When the agent read general side effects list, the patient said the only thing the patient did not have was nausea or vomiting and said the patient never loses their appetite.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Follow-up received contains No new information.
Patient reported reaction to first vaccine. After receiving dose, resident started feeling dizzy (at 3:15pm). at 3:25pm patient reported tingling of the bottom lip. Both resident reported with previous dose. AT 3:50PM patient reported no change, and reported to director of nursing that legs felt "heavy" and that her legs had fallen asleep. She did not want Benadryl. Director of nursing let staff member leave facility around 4:10pm, with another nurse driving her home after confirming resident felt well enough to leave.
HPV injection given IM in R deltoid.  Immediately after pt c/o pain at site.  2 minutes after injection pt was sitting in chair.  Unresponsive to verbal stimulus.  Head tilted to left.  Both hands began to jerk inward simultaneously and L leg was stretched forward.  Episode lasted approximately 5 seconds and pt responded to verbal/physical stimuli.  Pt's memory of event.  VSS.
Fatigue; Headache; Injection-site tenderness; Slight joint pain; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 17Apr2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included obesity, asthma and pollen allergy. Concomitant medications included paracetamol (MANUFACTURER UNKNOWN), diphenhydramine (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) and caffeine (MANUFACTURER UNKNOWN); all for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 27Mar2021 at 14:30 (at the age of 35-years-old) as a single dose, for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Apr2021 at 04:00, the patient experienced fatigue, headache, injection site tenderness and slight joint pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, headache, injection site tenderness and slight joint pain was resolved on an unknown date in Apr2021.  No follow-up attempts are possible. No further information is expected.
Pt call clinic at 13:00 and complained of hives, fatigue, swelling in lips, face and hands. Pt was brought into clinic and evaluated by physician. Pt administered 50 mg of Benadryl and released post observation.
Got sick; More than 35 days since first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) and PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick) and PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose). At the time of the report, ILLNESS (Got sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were provided
Get covid symptoms 27May/ put on Paxlovid; Get covid symptoms 27May/ put on Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27May2023, outcome "unknown" and all described as "Get covid symptoms 27May/ put on Paxlovid". The patient underwent the following laboratory tests and procedures: Pain assessment: (28May2023) level 8; (29May2023) level 8; SARS-CoV-2 test: (27May2023) Negative, notes: I get covid symptoms 27May but test negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient got covid symptoms 27May but test negative. In bed all day 28May with headache and body pains at level 8. On 29May got sore throat at pain level 8. On 30May was put on Paxlovid and by afternoon sore throat and fever gone and stopped pain meds.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300209235 Same drug/events, different patient;
a lot of people had allergic reactions; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (a lot of people had allergic reactions) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (a lot of people had allergic reactions). At the time of the report, ALLERGY TO VACCINE (a lot of people had allergic reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Devel maculopapular rash approx 1NOV91 on torso/back, spreading w/in 24 hrs to face & neck; Seen in ER 4NOV91; rash present no other s/s; Given meds;
Fever  a few hours after booster was administered. 3 days later heart racing, feeling like head would explode, severe anxiety, uncontrollable crying.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's relevant medical history and concomitant medication were not reported. On an unknown date in 2015 (reported as since 14-MAY-2015, which was the date the excursion occurred), the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route of administration, lot# and expiration date were not reported), which underwent supported temperature excursions. No adverse effects were reported. No PQC (product Quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
rapid arrhythmia; Couldn't breath, short of breath; pulse was 240; atrial fibrillation; palpitations during walking, heart started racing; This spontaneous case was reported by an other health care professional and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation), ARRHYTHMIA (rapid arrhythmia), PALPITATIONS (palpitations during walking, heart started racing), DYSPNOEA (Couldn't breath, short of breath) and HEART RATE INCREASED (pulse was 240) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031l20a and 012l20a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included TRIAMTERENE for Blood pressure high.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PALPITATIONS (palpitations during walking, heart started racing) (seriousness criterion hospitalization). In June 2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria hospitalization and medically significant). On 16-Jul-2021, the patient experienced ARRHYTHMIA (rapid arrhythmia) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Couldn't breath, short of breath) (seriousness criterion hospitalization) and HEART RATE INCREASED (pulse was 240) (seriousness criterion hospitalization). The patient was treated with METOPROLOL on 16-Jun-2021 at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), ARRHYTHMIA (rapid arrhythmia), DYSPNOEA (Couldn't breath, short of breath) and HEART RATE INCREASED (pulse was 240) outcome was unknown and PALPITATIONS (palpitations during walking, heart started racing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jul-2021, Heart rate: 240 (High) pulse was of 240.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient stayed 3 days in ICU and discharged 3 days later.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt states took flu shot on Wednesday 6OCT93; broke out w/hives noted 7OCT93 AM on awakening; hives on abod, inner aspect of both arms, groin thighs & back; c/o itching to groin area on 8OCT93; call MD 8OCT93;
Six days later developed rapid heart beat followed by dizziness and ringing in left ear. Rapid heart beat lasted three or four days. Dizziness 10 days. Still have ringing in ear on day 13. It has gotten louder.
Difficulty swallowing lasting one hour, had to continuously clear my throat of mucous, blood vessels burst under skin on both hands, gastrointestinal upset for three days.
15 cm by 6cm burns on top on rt arm swollen & red from DTaP.