chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer and described the occurrence of not responding to therapy in a 32-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medications included Birth control. In 1989 the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown details). In 1989, less than one year after vaccination with ENGERIX B, the subject experienced not responding to therapy. The reporter described herself as "a nonresponder". The reporter did not consult a healthcare provider regarding the event.
Rheumatoid arthritis flare up; reaction to 2nd dose of covid-vaccine/vomitting resulted in dehydration with Humira; Lethargic; Pain; reaction to 2nd dose of covid-vaccine/vomitting resulted in dehydration with Humira; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4362258-00.  A 34-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since 2021 (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Route of administration: Intramuscular), for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; LETHARGY (non-serious), outcome "unknown", described as "Lethargic"; PAIN (non-serious), outcome "not recovered"; VOMITING (non-serious), DEHYDRATION (non-serious), outcome "unknown" and all described as "reaction to 2nd dose of covid-vaccine/vomitting resulted in dehydration with Humira". The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up", "lethargic" and "pain" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "reaction to 2nd dose of covid-vaccine/vomitting resulted in dehydration with humira" related to BNT162b2.  Clinical informationSolicited report from the USA by a consumer of an adult female with events of Non-serious lethargic, pain, Rheumatoid arthritis flares and reaction to second dose of covid vaccine/vomiting resulted in dehydration with Humira (Adalimumab).Causality for Humira (Adalimumab). The reporters causality for the events of Lethargic, pain, Dose of covid vaccine/vomiting resulted in dehydration unknown vaccine/vomiting resulted in dehydration unknown onset was not rheumatoid arthritis flares, reaction to second onset and reaction to second dose of covid provided.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug 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.
Pt complained of "throat tingling", stated that she used benadryl with dose #1 and wanted to proceed with his treatment. No wheezes auscultated. Pt stated she did not want to use her epi pen.
Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; Shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby I started to feel flushed in my face and very warm, and felt my heart racing; pulse and BP both were elevated (HR 122 BP 155/80); pulse and BP both were elevated (HR 122 BP 155/80); This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the first dose of BNT162B2 (lot number: EL0140), intramuscular on 21Dec2020 10:30 at single dose in the left arm for COVID-19 immunization. There were no medical history. The patient's concomitant medications were not reported. The patient previously took amoxicillin and experienced allergies. On 21Dec2020 10:30, it was reported that shortly after having received the vaccine (approximately 5 min) while sitting in the designated lobby, the patient started to feel flushed in her face and very warm, and felt her heart racing. The nurse came and took her pulse and BP both were elevated (HR 122 BP 155/80), after three minutes her heart rate and BP came down and normalized again (HR 70 and BP 115/60). Stated that she has never had a similar experience. The patient did not receive any treatment for the events. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The with outcome of recovered on unspecified dates.
Chills , body aches, muscle pain, soreness at injection site and headache, fatigue x 4 days  Advil, rest, fluids  Currently on day 4 of fatigue , muscle aches and headaches
Case previously recorded as MA2009-3136. Initial case report received from a nurse via Med Com on 19 OCT 2009. A 6-month-old female patient, was vaccinated with H1N1 i.m. into the anterolateral aspect of the thigh on an unknown date. No adverse event was reported. Reference no. NA09-006628.
I developed severe chills, fever up to 102.2 (oral) diffuse myalgias, headache, and fatigue. I still have all of these symptoms now and I'm taking ibuprofen to help.
Sudden onset of tinnitus and hyperacusis 30 hours after vaccine administration which both have continued unabated for 6 weeks as of this writing. Have seen PCP and two ENTs and completed two courses of prednisone to no apparent effect. Had a hearing test which revealed mild to moderate hearing loss in right ear in certain frequencies; however, with no previous baseline hearing test, it's unknown whether the hearing loss occurred before or after vaccine administration. Have been referred to a tinnitus program for  Cognitive Behavioral Therapy, and Tinnitus Retraining Therapy.
left arm started to feel numb first, and then she started to feel it in her face/numbness on the side of her face; worried; This is spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient was having a side effect after taking the COVID vaccine today (21Dec2020). The patient experienced numbness on the side of her face on 21Dec2020. The patient added that she had to wait for 15 minutes and didn't have anything. The patient when driving on the way home, she started to feel numbness on her face. The patient clarified within 20 minutes of receiving the vaccine her left arm started to feel numb first, and then she started to feel it in her face. The patient has been trying to exercise it and move it because she was worried it would become weak. The patient was unsure what to do or if this is expected. The patient, while providing contact information she stated she was really worried (21Dec2020), and she can't finish the report at this time. The full report details were unable to be obtained. The outcome of the events was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Was very tired on Wednesday evening. Went to bed and had not sleep at all. Got up for work and felt terrible. Had a headache, coughing,wheeezing, sneezing, head feels groggy.
This spontaneous report was received from a 59 year old female patient reporting on herself. The patient's medical history included shingles before December 2015. The patient's concurrent conditions were not provided. On 22-DEC-2015, the patient was vaccinated with ZOSTAVAX injection (dose, lot #, expiration date and route of administration were not reported). There were no concomitant medication provided. On 22-DEC-2015, after ZOSTAVAX administration, the patient experienced pain and rash and on early January 2016, she was diagnosed with shingles by the physician. The patient was treated with prednisone (manufacturer unknown). It was also reported that the patient seemed to be recovered. On 14-FEB-2016, the patient experienced another rash. On 20-FEB-2016 (also reported as "on Saturday"), when she woke up she saw unspecified spots. It was also reported, that on an unknown date the patient experienced "fire and temperature". The patient sought medical attention- contacted her physician. The outcome of shingles was reported as recovered on an unknown date in 2016. The outcome of rash and spots was reported as not recovered/not resolved. The outcome of fire and temperature was unknown. The relatedness between the events and ZOSTAVAX was not provided. Additional information has been requested.
It's kind of warm; It itches more than anything; around where the injection was given it's red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (It's kind of warm), VACCINATION SITE PRURITUS (It itches more than anything) and VACCINATION SITE ERYTHEMA (around where the injection was given it's red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 012A21A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced VACCINATION SITE WARMTH (It's kind of warm), VACCINATION SITE PRURITUS (It itches more than anything) and VACCINATION SITE ERYTHEMA (around where the injection was given it's red). At the time of the report, VACCINATION SITE WARMTH (It's kind of warm), VACCINATION SITE PRURITUS (It itches more than anything) and VACCINATION SITE ERYTHEMA (around where the injection was given it's red) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.
Splitting headache, brain fog, muscle aches, low grade fever, nausea, changes to menstrual cycle including excessive bleeding for longer than normal cycle, intense cramping and sore breasts
their daughter received an adult dose by mistake; Dose 1 administered on 30-jun-2022 and Dose 1 administered on 21-Jul-2022; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (their daughter received an adult dose by mistake), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 30-jun-2022 and Dose 1 administered on 21-Jul-2022) and NO ADVERSE EVENT (no adverse event) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B, AS1414B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (their daughter received an adult dose by mistake), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 30-jun-2022 and Dose 1 administered on 21-Jul-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (their daughter received an adult dose by mistake) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 30-jun-2022 and Dose 1 administered on 21-Jul-2022) outcome was unknown and NO ADVERSE EVENT (no adverse event) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (their daughter received an adult dose by mistake) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 30-jun-2022 and Dose 1 administered on 21-Jul-2022).    No concomitant medication was reported. No treatment medication was reported.
Hair loss; This is a spontaneous report received from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 15Mar2021 at 15:00 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. The patient medical history included asthma, COVID-19. The patient previously received unspecified sulfonamide medications (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), celecoxib (CELEXA), fexofenadine (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and daily vita (MANUFACTURER UNKNOWN), all medications for unspecified indications. The patient did not receive other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received other vaccine (unspecified) on the same date 01Mar2021.  On 17Mar2021 at 07:00, the patient experienced daily hair loss and clumps of hair was falling out during shampooing and while brushing hair. It was noticeable daily shedding of hair on clothing and while running fingers through hair. 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 received treatment for the reported event. The clinical outcome of the event hair loss was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Severe headache, slight fever, shakiness, pain around injection site, swelling around injection site, redness, pain through entire arm.
The patient had a read itchy rash appear at injection site on arm measuring 8 inches by 4 inches. Also, for both doses that she has received, she has had an outbreak of Herpetic cold sores on and around the mouth in multiple locations.
Information has been received from a registered nurse (RN) concerning a 12-month-old female with no medical history or allergies who on 04-JAN-2008 was vaccinated subcutaneously with a 0.5 ml first dose of varicella virus vaccine live (Oka/Merck) (lot# 659356/1566U). There was no concomitant medication. On an unspecified date after 04-JAN-2008 the patient experienced cellulitis at the injection site area. The patient was seen by a physician on unspecified date and no laboratory or diagnostic tests were performed. Subsequently, the patient recovered from cellulitis at the injection site area as of 18-JAN-2008. No product quality complaint was involved. Additional information was received on 18-FEB-2008. The cellulitis began on 14-JAN-2008. No further information was reported at this time. Additional information is not expected.
This case was reported by a consumer via call center representative and described the occurrence of arrhythmia in a 75-year-old male patient who received SHINGRIX (batch number D9474, expiry date 10th September 2021) for prophylaxis. The patient's past medical history included arrhythmia (the patient had not had any episodes in 4 months). On 13th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th April 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm, fatigue and chills. On 15th April 2019, the patient experienced arrhythmia (serious criteria GSK medically significant), heart rate increased and low blood pressure. On an unknown date, the outcome of the arrhythmia, heart rate increased and low blood pressure were not recovered/not resolved and the outcome of the pain in arm was recovering/resolving and the outcome of the fatigue and chills were recovered/resolved. The reporter considered the arrhythmia, pain in arm, fatigue, chills, heart rate increased and low blood pressure to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX in right arm and his arm was sore following the injection and got worse 3-4 hours later. That evening he developed fatigue and chills. The fatigue and chills have resolved and his arm is less sore, but around 3:30 AM on the day of reporting the patient developed a very fast heart rate, arrhythmia and low blood pressure. This was still happening during the reporting. The patient had a history of arrhythmia, but had not had any episodes in 4 months. The reporter was consented to follow up.
10feb90 pt vax hepta B.  5 days later, pt ex. n/v/f, chills, h/a, and extreme vertigo. sx remitted spontaneously.
Large local reaction with redness, swelling, and pain surrounding injection site. Hand swelling one day post injection per pt - resolved now - local reaction, 95x80 mm at T+3.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 41 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Feb2023) Negative; (18Feb2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 03Feb2023 to 07Feb2023. The patient had sore throat and positive rapid antigen test on 18Feb2023, after testing negative after COVID infection that ended on 03Feb2023 (tested negative that date, and was then symptom-free).  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.
Localized erythema, edema at injection site. Flu-like symptoms developed approximately 24 hrs later. Headache, body aches, fever, nausea.
Patient reported developing a rash 2 weeks post vaccination. She said the rash was "moving around" and she tried to wait for it to improve without trying anything.  She was prescribed a z-pak and said the rash resolved, then returned. She is currently waiting to see a dermatologist regarding the rash.
need to restart series or just give 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: need to restart series or just give 2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 4-Oct-2023 The pharmacist called and they wanted to know how to proceed with series. The reporter asked that did they need to restart series or just give 2nd dose. The reporter had no details regarding patient or product. The reporter consented to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
SEVERE PAIN IN LEFT ARM; SORE TO TOUCH; This spontaneous report received from a patient concerned a female of unspecified age. 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 :Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced sore to touch. On 06-APR-2021, the subject experienced severe pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sore to touch, and the outcome of severe pain in left arm was not reported. This report was non-serious. This case, from the same reporter is linked to.