chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from lead medical assistant refers to a 3 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 26-APR-2019, the patient was vaccinated with improperly stored VARIVAX lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.   This is one of several reports received from the same reporter.
Reported feeling "light headed" without any other symptoms whatsoever.  Reports not having eaten breakfast & drinking minimal ; TX removal of mask, fresh air- chair reclined- ate breakfast bar & bottled water with improvement of symptom.  Drove off lot after suggested wait time plus 5 mins.
Developed red colored urine that started on the day after vaccine was received, and also had right lower back pain
Fever, full body aches and pains, headache, radiating pain from injection site to throat neck ribs, Diarrhea, nausea
I was just feeling tired and my doctor ran a blood test and found I had Diabetes. I am now on metformin and testing my blood sugar daily. I am now feeling fine, I think everything is working.
injection site pain; injection site swelling; joint pain (ankle); severe allergic reactions; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the right arm on 22Mar2021 at 15:45 (at the age of 45-years-old), as a single dose for COVID-19 immunisation. Medical history included histamine intolerance. The patient did not have any allergies to food, medications, or other products. Concomitant medication included cetirizine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 15:00, the patient experienced injection site pain, injection site swelling, joint pain (ankle) and severe allergic reactions. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the vaccination site pain, vaccination site swelling, pain ankle and allergic reactions was resolving at the time of reporting.  No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she had Pfizer for her 1st and 2nd dose), FEELING HOT (very warm), VACCINATION SITE SWELLING (arm got swollen, grown in diameter within the last couple of hours), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE INDURATION (hard) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0341C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccine (for 1st and 2nd dose).Past adverse reactions to the above products included Asthmatic with Pfizer COVID-19 vaccine.On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she had Pfizer for her 1st and 2nd dose), FEELING HOT (very warm), VACCINATION SITE SWELLING (arm got swollen, grown in diameter within the last couple of hours), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (hard) and VACCINATION SITE ERYTHEMA (bright red). On 19-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (she had Pfizer for her 1st and 2nd dose) had resolved. At the time of the report, FEELING HOT (very warm), VACCINATION SITE SWELLING (arm got swollen, grown in diameter within the last couple of hours), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (hard) and VACCINATION SITE ERYTHEMA (bright red) had not resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was reported.Patient experienced swollen and hard and itchy and very warm and bright red also mentioned that it had grown in diameter on arm. No treatment done yet, but patient is planning to take Benadryl.
The day after I received the vaccine I had typical arm soreness, body aches and was unusually cold for about a day and a half. I run hot most days. About a week later is when I began to notice fluttering of my heart. It feels exactly like what a fluttering heart valve would feel like. It occurs in episodes and seems to be random. Mt heart rate seems normal except with a heart flutter.   I made an appointment with a doctor 1/11/2022 and was able to see a cardiologist 1/12/2022. He performed an ECG which was normal and he ordered a electrocardiogram for 1/26/2022. I was told I have a weak heart valve. I haven't returned for the 24 hour heart monitor because I will be seeking treatment with a doctor. The facility I went to was another country.   I have never felt it before until about a week after the vaccine.
pt recv vax 1APR96 & 8APR96 pt devel chickenpox & potential erythema multiforme on leg & lower stomach;no further details were provided;
10/14/2023 Morning: Localized raised rash above armpit on left arm. Itchy and textured.  Still present as of 10/16/2023. Not spreading.  10/14/2023 Evening: Raised rash above armpit noted on right arm (injection site). Same Sx. Still present as of 10/16/2023 No treatment used.  No change in deodorant or exposure to allergens.
Information has been received from a medical assistant concerning a patient who on 12-NOV-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot# 658673/0990U). Subsequently, the patient experienced injection site pain and swelling. Unknown medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of the multiple patient report from the same source. Additional information has been requested.
Immediate event: injection site pain metallic taste and smell developing/continuing/escalating adverse reactions conserns: Constant and increasing muscular and joint pain, lack of resistance strength and motion in injection arm. Constant metallic taste and smell. Change in body odor, painful and excessive pimples, zits boils, blisters and blemishes  my face and little water like blisters all over my body. (never had acne in my life) Muscle spasms and twitching in hands and fingers. Irregular and painful mensural cycle.  Constant fatigue and lack of energy.
Dizziness; Vertigo; This is a spontaneous report from a non-contactable reporter (other healthcare professional). The reporter is the patient.  A 65-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Sep2021 at 16:00 (Lot number: EW0186) at the age of 65 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: HTN; "Asthma" (unspecified if ongoing); "AFib" (unspecified if ongoing) and "Allergy" (unspecified if ongoing), notes: Known allergies: yes. The patient received unspecified concomitant medications (unspecified if ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0183; Anatomical site: Left arm; Administration time: 17:00), administration date: 02Sep2021, when the patient was 65 years old, for COVID-19 immunisation.  The following information was reported: DIZZINESS (non-serious) with onset 01Nov2021 at 06:30, outcome "not recovered", described as "Dizziness"; VERTIGO (non-serious) with onset 01Nov2021 at 06:30, outcome "not recovered", described as "Vertigo". Therapeutic measures were not taken as a result of dizziness and vertigo.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. It was reported that dizziness/vertigo, started roughly 6 weeks after second vaccine. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Breakthrough COVID infection. Patient fully vaccinated 3/10/2021. Patient tested positive for COVID on 8/14/21.
Fever, Fatigue, muscle aches, severe headache and are sore at injection site. Injection was given in left arm and my arm had pain from the neck all down to my fingers.
had them last month, mild case/suspected vaccination failure; had them last month, mild case; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In May 2022, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-Jun-2022 Reporters comment: The patient self-reported the case via interactive digital media. The patient had received Shingles vaccine 4 years ago from reporting and experienced mild case of shingles last month. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Headache, NauseaVomiting, Syncope, lightheadedness, fatigue Narrative:
10/28/02 (report per mother). Gave Tylenol drops at 4pm 0.4 on dropper. Started screaming at 5pm would not take bottle-took some pedialyte. R upper leg was red and swollen and hot. Kept crying. Went to ER at 8pm.
This spontaneous report was received from a medical assistant and refers to a 5 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 05-NOV-2018, the patient was inadvertently vaccinated with one dose of ZOSTAVAX, subcutaneously, lot number was reported as N026187 (it was confirmed to be not valid), expiry date 25-DEC-2018 (the dose and site of administration were not provided) for prophylaxis. No adverse effects were reported.
Lips went numb, area around mouth went numb, fever, aches, diarrhea, chills, headache, tingling in arm, lethargic
Sweating increased; nausea; tired; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HYPERHIDROSIS (Sweating increased), NAUSEA (nausea) and FATIGUE (tired) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced PAIN (body aches), NAUSEA (nausea) and FATIGUE (tired). On an unknown date, the patient experienced HYPERHIDROSIS (Sweating increased). In September 2021, PAIN (body aches), NAUSEA (nausea) and FATIGUE (tired) had resolved. At the time of the report, HYPERHIDROSIS (Sweating increased) had not resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was  provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information was provided.   This case was linked to MOD-2021-622199 (Patient Link).
Fever, chills, uncontrollable shaking. Migraine, extreme body aches,  lasting over 24 hours. Loss of appetite.
A month or so after receiving the final shot in the GARDASIL series, I noticed a problem with my fingers. They would become cold and swell, then turn white or blue, upon exposure to any temperature below 30 degrees, once they reached normal body temperature, they would swell further to the point of extreme discomfort and begin to feel as though they were being burned. I noticed these symptoms for two years, with no relief and many puzzled doctors. In August I began noticing knee swelling, severe joint pain, difficulty walking, and severe fatigue. Fluid was removed from my joints to temporarily relieve the pain, I was prescribed with Prednisone to reduce any inflammation, and it helped for two to three weeks, then the symptoms returned. After an Emergency Room Visit, they discovered white blood cells in the fluid in my joints. After a referral to an Orthopedic Surgeon, and then a Rheumatologist, I was then diagnosed in November 2011 with Systemic Lupus Erythematosus, after a complete blood panel and a positive ANA test.
About 15 minutes after receiving the vaccine, patient reported some tightness in her chest. A few minutes later, she had a dry cough. The facility doctor checked her out and said her vitals were good and her breathing sounded normal. She continued with the work day as normal.
On 26NOV97 pt had contact w/varicella vax on thumb while administering vax to a pt & 27NOV97 pt devel blisters around mouth;pt had a pustule of thumb that scabbed over;
This spontaneous report as received from a Registered Nurse concerning multiple unspecified patients of unknown age. The nurse reported that on unknown date, multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB, PNEUMOVAX 23 (MARRS# 1510USA010024), M-M-R II (MARRS# 1510USA010025) or ROTATEQ (MARRS # 1510USA010026). No adverse effects were reported. No further information was provided. Additional information has been requested.
COVID ARM WITH EXTREME ITCHING IN THE AREA RED SWOLLEN CIRCULAR AREA TRAVELING DOWN FROM THE INJECTION SITE, DRY VOMITING, EXCESSIVE MUCUS, COUGHING TO THE POINT I SCRATCHED MY Aesophagus TO THE POINT OF SOME BLOOD, GLANDS SWOLLEN IN LYMP NODES, MINIMAL TASTE. THIRSTY
This spontaneous report as received from a registered nurse refers to a 4 month old patient. On 01-JUL-2013 the patient was vaccinated with the first dose of ROTATEQ (Lot# and dose not reported) oral. No adverse effects reported. It was not known if the patient sought medical attention. Additional information has been requested.
Bruising and swelling at injection site on the right deltoid. Redness below injection site on the right deltoid. Soreness in the right arm.
Pt given a vaccine from a vial that had been opened more than 24 hours before.  No ADRs reported.  Vaccination repeated with a "fresh" vial same day.
COVID-19 INFECTION; This spontaneous report received from a patient concerned a 30 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint:  The suspected product quality complaint has been confirmed to be void:y based on the PQC evaluation/investigation performed.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.
Rash near the injection site after 10 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash near the injection site after 10 days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (ASPRIN), PRAVASTATIN, METOPROLOL SUCCINATE (TOPROL XL) and CETIRIZINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash near the injection site after 10 days). At the time of the report, VACCINATION SITE RASH (Rash near the injection site after 10 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided   Reporter did not allow further contact
Injection site reaction, itchy; Injection site reaction, redness; Warm; Tender; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Injection site reaction, itchy), INJECTION SITE ERYTHEMA (Injection site reaction, redness), VACCINATION SITE WARMTH (Warm) and VACCINATION SITE PAIN (Tender) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site reaction, itchy), INJECTION SITE ERYTHEMA (Injection site reaction, redness), VACCINATION SITE WARMTH (Warm) and VACCINATION SITE PAIN (Tender). At the time of the report, VACCINATION SITE PRURITUS (Injection site reaction, itchy), INJECTION SITE ERYTHEMA (Injection site reaction, redness), VACCINATION SITE WARMTH (Warm) and VACCINATION SITE PAIN (Tender) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
worsening chest pain 2 hours after getting tha Moderna- came to the ED had  STEMI-- ailifted to hospital
covered in sweat; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (covered in sweat) and DIZZINESS (dizzy) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041J21A, 038K20A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood cholesterol abnormal and Blood pressure high.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced HYPERHIDROSIS (covered in sweat) and DIZZINESS (dizzy). At the time of the report, HYPERHIDROSIS (covered in sweat) and DIZZINESS (dizzy) outcome was unknown.            The patient's took medicines for cholesterol and high blood pressure.  Patient did not take any medication for the symptoms.  It was reported that the patient woke up 20 minutes ago covered in sweat and was dizzy.
Patient was administered 6months-5 year old vaccine instead of the adult vaccine. Patient was called and she is doing fine.
Information has been received from an office receptionist concerning a 15 year old male who on an unspecified date was vaccinated IM with a dose of GARDASIL (lot# unspecified, site not reported).  The receptionist stated that it was not an accident that a male probably older than 15 years, received the vaccine.  She "was told to give it to him and she did."  He has received only one dose so far.  The patient left the office and went to the hospital because his father was having major surgery that day; he fainted there, about 1 hour ago after the vaccination.  She wasn't sure if he fainted because of the vaccine or because of the stress he was under by being upset by his father's surgery.  He called the office to report the fainting.  She stated that he is fine now.  Additional information has been requested.
(1) Adacel given (2) Red bump on left deltoid (3) Keflex given (antibiotic)
no adverse event; patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 06-FEB-2020, the patient was administered an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S006017 (Expiration Date 27-FEB-2021), as prophylaxis  (dose, frequency, route of administration were not reported). It was incorrectly stored from minus (-) 14 Celsius degrees (°) to-10°C (-13.5°C) for 41 minutes and had no previous temperature excursion. The error was identified due to a data logger. The sterile diluent (lot# S031278 with expiration date 16-JUN-2022) was properly stored. No additional adverse event (AE) information was provided.
Really hurt when pneumonia shot was injected and that night arm hurt and was swollen and beet red and painful!! Didn't even need that shot again. Had it 8 years ago from primary care doctor! I thought it was something new???
pt recv vax 10MAY99 & instructed employee to report to  EHS if rash appeared;report to EHS 17MAY99 w/rash on face, upper chest, both arms, underarm & abd & back;T99.0;
Sore arm; headache; diarrhea; weakness; tachycardia; dehydrated; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 70-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, headache, diarrhea, weakness, tachycardia and dehydration. On an unknown date, the outcome of the pain in arm, headache, diarrhea, weakness, tachycardia and dehydration were unknown.   It was unknown if the reporter considered the pain in arm, headache, diarrhea, weakness, tachycardia and dehydration to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of shingrix and had sore arm, headache and diarrhea. Then some week ago has weakness, tachycardia and diarrhea. No patient's identifiers provided, no lot number, expiration date, vaccination date was provided. The reporter did not specify when the symptoms began or when they ended. The reporter consented to follow up.