chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 28-JAN-2019, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (1 injection, via intramuscular, lot #: R0123571, expiration date: 19-MAR-2021; strength and anatomical location were not reported)for prophylaxis (product storage error). No adverse effect was reported. The LIQUID PEDVAXHIB was exposed to 0 degree Celsius for 45 minutes. There was no previous temperature excursion. The data logger was involved. This is one of several reports received form the same reporter.; Sender's Comments: US-009507513-1902USA008818: US-009507513-1903USA006922: US-009507513-1903USA006923: US-009507513-1903USA006924: US-009507513-1903USA006926: US-009507513-1903USA006927: US-009507513-1903USA006928: US-009507513-1903USA006929: US-009507513-1903USA006930: US-009507513-1903USA006931: US-009507513-1903USA006932: US-009507513-1903USA006933: US-009507513-1903USA006934: US-009507513-1903USA006935: US-009507513-1903USA006936: US-009507513-1903USA006937: US-009507513-1903USA006938: US-009507513-1903USA006939: US-009507513-1903USA006940: US-009507513-1903USA006941: US-009507513-1903USA006942: US-009507513-1903USA006943: US-009507513-1903USA006944: US-009507513-1903USA006945: US-009507513-1903USA006946: US-009507513-1903USA006947: US-009507513-1903USA006948: US-009507513-1903USA006949: US-009507513-1903USA006950:
Developed autoimmune thrombocytopenia petechiae and purpura onset 02/26/2000.
She received her vaccine at 12:55 and took a seat about 10 feet away for the 15 minute wait period.  About 1-2 minutes after that she put her hands up in the air and then fainted and fell off her chair.  She hit left forehead on the ground and was face down.  Nurse rushed to her and called her name and she responded immediately and was rolled over once she stated nothing hurt.  She was kept lying down due to complaints of dizziness.  EMS was Called.  Dizziness went away after about 6 minutes and she only complained of nausea then.  EMS arrived at 1;18pm  and sat pt up in chair and she refused medical treatment.  She called her friend to come pick her up and nurse walked her to elevator and up to lobby where her friend was waiting and was informed of what happened.
partial face paralysis; This is a spontaneous report from a contactable consumer. A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient reported he was never allergic to anything before vaccination. On an unspecified date, after the vaccination, after having a piece of Chocolate that he used to eat for the past 30 years, he had a partial face paralysis and he doesn't know if it was due to the vaccine. Patient went to hospital due to event. The outcome of event was unknown.  Information on the Batch/Lot number has been requested.
expired dose administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number unknown, expiry date January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   In April 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In April 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-May-2022 Reporter's Comments: The health care professional reported an expired dose of bexsero was administered to patient on April 2022. The reporter consented to follow up. No other information available. Additional Supportive Information: The patient received Bexsero which was already expired which led to expired vaccine used.
Vaccine was administered to patient past the BUD of 17-Feb-2023; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) 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)) (batch no. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history, conditions, allergy, concomitant diseases, or risk factor (including any previous COVID-19 diagnosis). It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     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) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) 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 (Vaccine was administered to patient past the BUD of 17-Feb-2023).    Concomitant drugs were not reported. It was reported that vaccines were administered to 20 patients between 13-Mar-2023 to 05-Jun-2023 past the BUD of 17-Feb-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Treatment medications were not provided.  This case was reported for patient 20 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
Migraine x 1 week, increase in severity of daily headaches x 12 mo. Brain fog. fatigue. word searching, slow mentation.   IV nutrition  has improved symptoms, but they are still there.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 at 08:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in right arm 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 had no relevant medical history. No known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 68-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterated that because the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of December-2021, January-2022, and February-2022. They were filling out a temperature excursion assessment with the agency currently. Also reported that no adverse reactions were experienced by any patients.
Within 4 days of DTAP and VARICELLA vaccines, patient had a regression in speech and motor coordination.  As noted by family and occupational therapist, began stuttering and lost coordination.  Symptoms lasted approx. 1-2 months and began to dissipate with continued OT/PT.
Caller states that the 2 month old is well without any residual effects or side effects; PNEUMOVAX 23 was given to a 2 month old instead of PCV 13. Caller states that this was a sound alike look alike medication error; PNEUMOVAX 23 was given to a 2 month old instead of PCV 13. Caller states that this was a sound alike look alike medication error; 2-months old patient was vaccinated with Pneumovax23; This spontaneous report was received from a medical assistant referring to a 2-month-old patient of unknown gender. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.     On 22-SEP-2020, the patient was vaccinated with first dose in the series of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) as prophylaxis  (concentration, route and anatomical location of administration were not reported; lot number S029916 and expiration date  12-JUN-2021) instead of pneumococcal 13v conj vaccine (crm197)(PNEUMOCOCCAL 13V CONJ VACCINE (CRM197)) (reported as PCV 13). The reporter stated that this was a sound alike look alike medication error (product name confusion, product administered to patient of inappropriate age and interchange of vaccine product), also it was reported that, the 2-month-old was well without any residual effects or side effects.  This is one of two reports from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029916; expirationdate: 12-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA002605:
vaccinated with an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   On 25th July 2022, the patient received Havrix. On 25th July 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 25-Jul-2022 Reporter's comment: The registered pharmacist reported that on day of reporting the patient was vaccinated with an expired dose of Havrix. The reporter consented to follow-up. Additional supportive information: The patient received an expire dose of Havrix, which led to expired vaccine used.
Patient received expired dose of deptacel vaccine/No AE; Initial information was received on 25-Feb-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 19 month old male patient who was vaccinated with expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  On 24-Feb-2020, patient received Concomitant vaccine HIB VACCINE CONJ (TET TOX) (ACTHIB) for prophylactic vaccination.  On 24-Feb-2020, the patient received a dose 4 of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5367AA, 30-Jan-2020] via an intramuscular route at the left thigh for prophylactic vaccination.  It was a case of actual medication error due to Expired vaccine used. Patient received expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (expired product administered).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Shortness of breath; Heart palpitations; body aches and swelling in my arm and pain; fatigue. Those lasted for three or four days. except the fatigue lasted five days or so and the shortness of breath and heart palpitations lasted 6-8 weeks - until I  started Propranolol. I started taking Flovent - and that helped too.  The Propranolol helps get the heart palpitations stable but the shortness of breath has improved.
2 minutes after receiving vaccine, patient developed diffuse flushing, dyspnea and dizziness/presyncope Resolved after about 8 minutes Vital signs all stable
Severe pain at deltoid muscle where injection was given.  Using Tylenol and ibuprofen routinely without any relief.
I experienced soreness at the injection site. During my regular annual physical in February 4, 2021 and it showed that two particular liver enzymes showed AST 791 and ALT 1319 which made my PCP's become concerned because the range was higher than it should be. I had subsequent blood work showed that the enzymes were still to high AST756 and ALT 1413. I was sent to see a specialist for follow up and was diagnosed with Autoimmune Hepatitis. I was given prescription medications Prednisone (has since been replaced with Budesonide as of 8/10/2021) and Azathioprine until further notice. My diagnosis is now a lifetime condition of Autoimmune Hepatitis.
23mins post vaccination pt c/o feeling faint; chest tightness (neg for hsx of anxiety) Vitals: @16:55 BP 123/66, HR 81, RR 20, O2 Sat 98% -- > @17:01 116/70, 81, 98% -- > @17:10 123/68, 80, 99% No pallor or SOB @17:01 Pt continues to c/o tightening in chest @17:10 pt states he feels better justed wanted to check his BP before departing. Pt stable and released from the vaccination site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2022 at 16:00 as dose 4 (booster), single (Lot number: FJ4987) at the age of 70 years, in right arm 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown. Additional information: Other medication in 2weeks: No. Anti viral details: product: COVID 19 Treatment, brand: Pfizer Paxlovid, treatment start date: 16Jun2022, treatment stop date: 21Jun2022. Adverse event: None to vaccinations. covid rebound following Paxlovid treatment. Adverse event start date: 24Jun2022. The patient was recovering. AE treatment: Augmentin. known allergies: No. other medical history: healthy.  results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
fever, chills, nausea,diarrhea , fatigue and STRONG headache,  muscle/ joint aches, injection site is swollen and raised. rash continues thru day 7. terrible itching..throat, upper torso, arms, face. a general feeling of anxiety and feeling odd...hard to describe...kinda woozy, off. day 5 a strange blood blister came up near injection site still experiencing itching badly
Swelling the size of an orange at injection site.   Redness, hot, painful.
10:15 PM (10-25-2010) - cough and tightness in throat. Within minutes, progressed into wheezing and difficulty breathing. Tightness could be felt further down wind pipe. At this point, I did not connect any of this to the flu shot. No hives, no heart palpitations, no dizziness, no fever. I had no noticeable problem at the injection site. 11:00 PM (10-25-2010) - Took 4 tsp of liquid DIMATAPP (which is what I take for my seasonal allergies) prior to going to bed, hoping it would ease the difficulty in breathing. I don't think it helped. 2-3 AM (10-26-2010) - awoke with inside of upper mouth swollen, still had difficulty breathing, had chills and all-over body aches, felt feverish. I realized that all of these symptoms may be a reaction to the flu shot. 7-8 AM (10-26-2010) - awoke, still with body aches. Swelling in mouth subsided, but still a bit swollen. No difficulty breathing. Still felt flushed and feverish. Took oral temperature - did not register above 98 degrees. I took my normal daily medication (including low dosage aspirin). I took no other pain relief medication. By the evening of 10-26-10 - I was back to normal, no difficulty breathing, no swelling in mouth, no body aches, no flushed feeling.
The patient experienced syncope and fell out of chair.  The patient was unconscious for about 15 seconds. The patient was observed in medical tent and had two episodes of bradycardia and fainted twice more. The patient was transported to Hospital.
This spontaneous report as received from a Medical Assistant refers to a 70 year old female patient with diabetes mellitus, hypertension and hyperlipidaemia. Concomitantly, the patient was taking many unspecified medications. On 03-AUG-2017, the patient was vaccinated with PNEUMOVAX 23 Lot # N010109 with an expiration date on 20-NOV-2018, Single dose, 0.5 ml for prophylaxis. In August 2017, the patient experienced injection site erythema, injection site warmth and injection site swelling. She visited the physician and it was  prescribed her cephalexin (KEFLEX) for the treatment of the adverse events. The outcome of injection site erythema, injection site warmth and injection site swelling was reported as recovering/resolving.
pt recvd vax; 2-3 later prolonging crying > 3 hrs; unconsoled w/ higher pitch than nl;large local rxn at site; seen at er; rx w/ meds;
after 4 weeks still have lump on neck; next morning swelling and redness was in neck.; next morning swelling and redness was in neck.; after 6 hours- left side of face was hot, swelled and numb feeling.; after 6 hours- left side of face was hot, swelled and numb feeling.; after 6 hours- left side of face was hot, swelled and numb feeling.; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 29Apr2021 10:00 (Batch/Lot Number: EW0172) as single dose for COVID-19 immunisation. Patient age at vaccination was 48 years old. The patient medical history was not reported. Patient was not pregnant. Concomitant medications included other medications within 2 weeks of vaccination. The patient previously took fluconazole (DIFLUCAN) and experienced allergy. Historical vaccine included 1st dose of BNT162B2 (lot number=ER8733) on 01Apr2021 in left arm for COVID-19 immunization at age of 48 years old. After 6 hours (29Apr2021 16:00)- left side of face was hot, swelled and numb feeling. Next morning (30Apr2021), swelling and redness was in neck. After 4 weeks, patient still had lump on neck. The events resulted in emergency room visit. Patient received treatment for the events included diphenhydramine hydrochloride (BENADRYL) and steroids. The events were not resolved at the time of reporting.
Narrative: COVID infection following COVID vaccine series 03/09, Pfizer, dose #1 04/01, Pfizer, dose #2 08/30 COVID swab, result: detected 08/30 pt cc: Fatigue exposure; WIFE clinically resolved
After 8 minutes of administering vaccine and pt stated he was thirsty, instructed to remain on exam table, father sitting 2 feet in front of him. He told his father of not feeling well and he turned to side and fell off exam table, hitting his head on floor. Father not sure if he had syncope episode. Pt was found on floor by staff and father and staff assisting pt to chair and was lethargic, diaphoretic, brady-cardic upon placing O2 Sat probe and then when up to 60's and hypotensive 88/40. Opening eyes on ammmonia inhalant. Neuro checks within normal limits. Started intravenous fluids with normal saline one liter. Father states patient had not eaten all day due to pending appointment with dental In same clinic. Ice pack to head applied. After 7min pt more alert and taking fluids and eating cookies and crackers. No trauma, bruise or bump to head. Moving all extremities but stated feeling weak. Instructions given to parent on discharge to watch for any mental changes, dizziness, nausea, vomiting, severe headache, high temperature and to call clinic or take patient to nearest ER or call 911.
Chest pain b/p 176/79     11.25 First at 11:17 am b/p 166/70   11.30, 185/76, 165/74   11.21