chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed an autoimmune condition; probably has sjogren's syndrome; few symptoms of rheumatoid arthritis; couldn't walk; morning stiffness; joint pain; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the second of two reports.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient developed an autoimmune condition, probably has Sjogren's syndrome, had a few symptoms of rheumatoid arthritis, couldn't walk with the morning stiffness and joint pain  after the vaccine. The outcome of the events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of reported events 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.,Linked Report(s) : US-PFIZER INC-202100998397 same reporter/product/event, different patient
Intense flare up of pre-existing systemic photosensitivity from drug induced lupus originally tetracycline 1995. 3 types of rashes - optic migraines heightened sensitivity to light source. Calmed to pre-existing light sensitivity level (permanent state) over 5 months. No treatment available.
a rash on the arm where the first dose was administered / a rash an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (a rash on the arm where the first dose was administered / a rash an allergic reaction) 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 VACCINATION SITE RASH (a rash on the arm where the first dose was administered / a rash an allergic reaction). At the time of the report, VACCINATION SITE RASH (a rash on the arm where the first dose was administered / a rash an allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
COVID-19 antibody test negative; This spontaneous case was reported by an other and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (COVID-19 antibody test negative) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (COVID-19 antibody test negative). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (COVID-19 antibody test negative) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided by the reporter.  Concomitant medications were not reported by the reporter.  Medical history were not provided by the reporter.
No additional adverse effects reported.; patients have been administered improperly stored vaccines; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 12-JUN-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot # S016870, expiration date 26-FEB-2022 (exact dose and injection site were not reported) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial, orally, lot # 1660958, expiration date 23-FEB-2021 (exact dose and injection site were not reported), both for prophylaxis.  Administered doses of vaccines experienced the temperature excursion of below 36 degrees Fahrenheit (29.5 degrees Fahrenheit) for 10 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported.; Sender's Comments:  US-009507513-2007USA001137: US-009507513-2007USA001783: US-009507513-2007USA001781: US-009507513-2007USA001780: US-009507513-2007USA001779: US-009507513-2007USA001778: US-009507513-2007USA001777:
hands and feet swelled up, and they were on fire and very itchy; hands and feet swelled up, and they were on fire and very itchy; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Deltoid Left on 06Aug2021 (Batch/Lot Number: FA7485) as dose 1, single (at the age of 64 year) for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis a year and a half ago, ongoing Hashimoto's disease diagnosed 10 years ago, ongoing vasculitis diagnosed 10 years ago. Concomitant medication included methotrexate (METHOTREXATE). The patient did not have any prior vaccinations within 4 weeks. There was no additional Vaccines administered on same date of the pfizer suspect. History of all previous immunization with the Pfizer vaccine considered as suspect was no. Vaccine was not administered at military facility. Time of the vaccination was given (24 hour clock) at noon. The patient experienced hands and feet swelled up, and they were on fire and very itchy on 06Aug2021. She was taking Methotrexate, and her rheumatologist told her to stop before getting the Vaccine so it would take effect better. She was off the Methotrexate for a week before the shot. Caller doesn't have the NDC/lot/expiration for the Methotrexate. There was no emergency Room and physician Office visit. She has used a steroid cream that she has had, and it did help. It was called Triamcinolone Acetonide 0.1%. Outcome of the event was recovered on 08Aug2021.
Very sore, aching arm. So bad it woke me up the first night. Next day, all over body  aches, lethargy, some nausea. Fever of 101. Stayed home, went to bed. Day three, left arm still aches, I'm still tired.
Administered expirated vaccines to 29 employees and used vials which were thawed before 29Oct2021; 29 employees were vaccinated with 0.5ml Oct29th2021 as a booster; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expirated vaccines to 29 employees and used vials which were thawed before 29Oct2021) and ACCIDENTAL OVERDOSE (29 employees were vaccinated with 0.5ml Oct29th2021 as a booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expirated vaccines to 29 employees and used vials which were thawed before 29Oct2021) and ACCIDENTAL OVERDOSE (29 employees were vaccinated with 0.5ml Oct29th2021 as a booster). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expirated vaccines to 29 employees and used vials which were thawed before 29Oct2021) and ACCIDENTAL OVERDOSE (29 employees were vaccinated with 0.5ml Oct29th2021 as a booster) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist reported that they had used the look up tool that shown expiry date 29-Oct-2021 and on the box is 01-Nov-2021 for frozen vials, but vials were thawed before 29-Oct2-021.  No concomitant medications were reported.  No treatment medications were provided.  Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Follow up received contains non significant information. On 08-Nov-2021: Follow up received contains non significant information.
Severe, Symptomatic Aortic Stenosis; procedure - Successful Transcatheter Aortic Valve Replacement. Recovery in hospital; discharged to home. Hospital admission within 6 weeks of receiving the COVID vaccine.
Immediate pain radiating to ear and head. Within 1hour Massive headache that lasted until the morning of 04/10/2021.  Headache so bad could not touch my head without  pain, pins and needles.
1st COVID immunization 1/7/2021,  COIVD positive results on 1/16/21,   1/24/21 O2 sats decreased to 78%, 1/24/21 reveived the Bamlanivimab infusion 50 ml/hr. 1/24/20 chest x ray 1/24/21 She was sent to hospital and admitted. 1/27/2021 Expired
Vaccine given on 19Mar06.  40 hrs of fever off and on. Increased crying by the 3rd day. Decreased appetite by the 4th day. Swelling face and feverish on the 6th day. Pin like rash on the 7th day. All of the above on the 8th day.
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses improperly stored VARIVAX (lot # L024252 with expiration date 30-JUN-2017; dose and route were unknown). The vaccines were exposed under temperature of 40.3 degrees Fahrenheit for 9 hours and 52 minutes. There were no previous temperature excursions. Data Logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
supraclavicular lymphadenopathy on same shot was given for gardasil #1 and #2
Approx 7 hours after receiving 2nd Moderna vaccine I had a fever of 102, chills, body aches, no appetite. Continued thru the next day
This spontaneous report was received from a nurse (reported as an administrator), and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and drug reactions/allergies were not reported. On 11-JUL-2017, the patient was inadvertently administered a dose of VARIVAX lot # L025207, for prophylaxis (dose, frequency, and route were not reported) which expired on 07-JUL-2017. Other suspect therapies included sterile diluent (strength, dose, frequency, route, lot #, expiration date and indication were not reported). No adverse effects were reported.
Child born with high bilirubin issue. Other mothers who have had babies at the same time have had the same bilirubin problems. some have been hospitalized, others just needing the bililight. The only thing in common was the covid vax.
The pt had to get the new bivalent booster for pfizer. Since the pfizer monovalent and bivalent vaccine vials look the same, the monovalent vial was grabbed from the fridge instead of the bivalent vial.
Whole body rash, SOB, itching that lasted several days despite taking allergy medications.
This spontaneous report was received from a medical assistant and refers to a 26 year old female patient. The patient did not have any pertinent medical history, drug reactions or allergies. She also did not take any concomitant medications. On 20-MAR-2017, the patient was vaccinated with the first dose of VARIVAX lot number M031969, expiration date 30-JUN-2017, for prophylaxis (exact dose and route of administration were not provided). The vaccine was reconstituted with sterile diluent (manufacturer unknown). On 21-MAR-2017, the patient called medical assistant to report that her arm was red and swollen at the injection site since an unknown date in March 2017 and she was advised by a physician to try cold therapy for treatment. On 23-MAR-2017, the patient came into the office to see the physician and she had redness and swelling at the injection site which was now 3 cm in size. The patient also stated that at that time the site of injection was itchy and painful since an unknown date in March 2017. The physician gave the patient diphenhydramine hydrochloride (BENADRYL) (form, dose, frequency were unspecified) and hydrocortisone (manufacturer unknown) cream for a treatment. The medical assistant stated also that the administered dose of VARIVAX was properly stored throughout its time at their facility and no temperature excursion had occurred prior to the administration. There were no lab diagnostic studies performed. There was no product quality complaint involved in this case. Action taken with sterile diluent (manufacturer unknown) was not provided. The outcome of adverse events and causality between the events and VARIVAX and sterile diluent (manufacturer unknown) were not reported. Additional information has been requested.
I had the sensation/taste in my  throat of a solvent/Chemical shortly after the injection,  which lasted about an hour.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medication reported. No treatment medication reported.  This case pertains to 29th of the total 190 patients.   This case was linked to MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-704335:Master case
Crying. Hoarse Cry and Voice. Sleepy and Crying for days. Stiff.
Tested positive for Covid on Sunday, 17Apr2022; Tested positive for Covid on Sunday, 17Apr2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: EK4176), on 15Feb2021 as dose 2, single (Lot number: EL9266) and on 04Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 57 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 17Apr2022, outcome "unknown", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Tested positive for Covid on Sunday, 17Apr2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Apr2022) positive. Therapeutic measures were taken as a result of covid-19.  Follow-up attempts are completed. No further information is expected.
no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 17-APR-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter. ; Sender's Comments:  US-009507513-2106USA007355:
My stomach hasn't felt this tight; Ridiculous amount of diarrhea; My arm hurts a bit; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 08May2021 at 13:00 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09May2021 at 00:00, the patient experienced diarrhea, his arm hurt and had stomach tightness. The day after first shot, on 09May2021 at 12:52, at the time of report, the patient was experiencing a ridiculous amount of diarrhea. It wouldn't stop. It could smell his fear. The patients arm hurt a bit but it was not too terrible. His stomach hadn't felt so tight since he ate an entire box of taco bell's party pack nachos with extra jalapenos. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events ridiculous amount of diarrhea, arm hurt a bit but it was not too terrible and stomach tightness was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Syncopal episode:  Patient experienced pallor, weekness, lightheaded,  fainted and fell to floor. Did not respond to verbal stimuli x 1 minute.  Awakened  and responded appropriately within 2 minutes.   Sustained no injury.
Got boosted 2 times and both times it felt like a cold; Got boosted 2 times and both times it felt like a cold/ didn't think he had it. Had to test and it came back positive; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (Got boosted 2 times and both times it felt like a cold) and COVID-19 (Got boosted 2 times and both times it felt like a cold/ didn't think he had it. Had to test and it came back positive) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (His first attack was a year ago.). Concurrent medical conditions included Pituitary adenoma. Concomitant products included SOMATROPIN (GENOTROPIN) for Pituitary adenoma, LEVOTHYROXINE and DEXAMETHASONE for an unknown indication.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Got boosted 2 times and both times it felt like a cold) and COVID-19 (Got boosted 2 times and both times it felt like a cold/ didn't think he had it. Had to test and it came back positive). At the time of the report, FEELING COLD (Got boosted 2 times and both times it felt like a cold) and COVID-19 (Got boosted 2 times and both times it felt like a cold/ didn't think he had it. Had to test and it came back positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         It was reported that patient was used the device about 5 years and will miss doses until new pen arrives. Pen has some numbers and lines for a dead battery. pen showed F9. Cartridge proceeded to put in a cartridge and that came out. it would not move and so patient pushed on the plunger and all of a sudden it just kept going and everything came out.  Patient stated that he was getting over Covid. He was pretty well boosted thanks to us. Patient first attack was a year ago and patient does not know the specifics on each vaccine. Provided Moderna Covid vaccine on 11-Oct-2022 and patient had a booster the year before also.  Patient started taking Genotropin about 10 years ago.  Patient had bloodwork a month ago because it seemed like medication wasn't working so patient doctor determined that patient's Levothyroxine and Dexamethasone doses needed to be adjusted so patient's Genotropin could work better and changed the time of day patient took it.  No treatment medication was reported.   This case was linked to MOD-2023-705975 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Jan-2023: Follow-up received: PQC number was updated.
A report has been received from a Physician concerning a patient, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The patient reported four patients received expired FLUMIST QUADRIVALENT. The outcome of the event of four patients received expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious by the reporter.
Outbreak of shingles on the left side of my face and scalp involving pain around my temple, cheek, forehead, and ears and a rash on my upper temple and scalp.