chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AFib; I seem to have heart problem; Heartbeats irregular; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 as dose number unknown (booster),single (Lot number: GJ3277) at the age of 79 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: bnt162b2 (LOT# (EL9262)), administration date: 28Jan2021, when the patient was 78-year-old, for Covid-19 Immunization; bnt162b2 (EN6201), administration date: 24Feb2021, when the patient was 78-year-old, for Covid-19 Immunization; bnt162b2 (30135BA), administration date: 16Oct2021, when the patient was 78-year-old, for Covid-19 Immunization; bnt162b2 (FK9729), administration date: 09Apr2022, when the patient was 79-year-old, for Covid-19 Immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset Mar2023, outcome "unknown", described as "AFib"; HEART RATE IRREGULAR (non-serious) with onset Mar2023, outcome "unknown", described as "Heartbeats irregular"; CARDIAC DISORDER (non-serious) with onset Mar2023, outcome "unknown", described as "I seem to have heart problem". The patient underwent the following laboratory tests and procedures: Heart rate: (Mar2023) irregular. Therapeutic measures were taken as a result of atrial fibrillation, cardiac disorder, and heart rate irregular which includes Diltiazem CD capsule orally once a day, and Eliquis 5mg tablet twice a day by mouth since 17Mar2023. Clinical course: Consumer stated, "So, I have taken, I have the Pfizer COVID vaccination since Jan2021. I have had my last booster 15Oct22 and it is very strange because in Mar2023. I seem to have heart problem I have irregular heartbeats, I have AFib and I was going to get another vaccine booster but I am not quite sure I should be doing that because I am wondering if after all the vaccines that accumulated and now it might have affected my heart. Is that possible? Have you heard of other cases? I just do not know what to do?" Furthermore, the patient stated that she had Afib a heart problem since March of this year and she was on medication for it. Patient stated that she has not been on medication after all. She has taken no medication before that. The patient has not taken any other vaccine 4 weeks prior to Covid vaccine.
Fever x 3 days (so far) and varicella type rash at site of vaccination.
Got it again; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had it twice).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got it again). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received one dose of shingles vaccine and experienced shingles again. The patient stated that they did not tell him/her to receive a booster dose. Follow-up would not possible as no contact details were available.
Herpes Zoster; Information has been received from a lawyer regarding a case in litigation, regarding a currently approximately 67 year old male patient.  The patient's concurrent conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not provided. On (or about) 29-APR-2016, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, after receiving the vaccine, on unknown date, the patient was treated by a healthcare provider for herpes zoster. At the time of the report, the outcome of herpes zoster was unknown. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
28 hours after booster vaccine, red rash with fluid-filled pustules forming left flank and back. No fever. Contacted primary care clinic on-call provider on 12/12/2021.  Pt took tylenol 1000mg and benadryl 25 mg.   Rash continues to spread and more fluid filled sacs form.  Pain increasing. No fever.  In contact with medical providers.  Pt seen by physician on 12/14/2021, 48 hours after initial rash appearance. Diagnosed with shingles herpes zoster. Valacyclovir prescribed. Pt had prior shingrix vaccines on 11/10/2018, and 4/20/2019.  Also noted at office visit was prepatellar bursitis left knee.
Pt awoke on 1/3/03 with local redness and swelling on arm around immunization site (left deltoid). Later in the afternoon, the redness and swelling had spread up and down arm as well as feeling warm to touch.
Brain fog; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on an unspecified date for COVID-19 immunisation. The patient reported she received both doses of BNT162B2 and she had brain fog immediately after the second dose. The clinical outcome of brain fog was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
April 9 to 10th overnight fever of 101, body aches, dizziness and nasueas leading to fall. Swollen glands into Saturday, Sunday and still today although better. Swollen especially in neck on left side where shot was given this led to dizziness.
Left arm in severe pain, unable to lift it in any direction or use it to pull or push or lift anything, pain worsens at night, can't sleep, continues to this date with only slight improvement.
Covid shot reaction and blood cloths in the leg; Covid shot reaction and blood cloths in the leg; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): US-AMGEN INC-23-0138818-SR-01, US-AMGEN-USASL2023086947.  This serious solicited report (USASL2023086947) was reported on 18/MAY/2023 by a consumer from a commercial program and involves a 83 year old female patient who experienced COVID shot reaction and blood cloths in the leg [PT: thrombosis, PT: immunisation reaction] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. No current medical condition was reported. No concomitant medications were provided.The patient's co-suspect medication included Covid-19 Vaccine. The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient had (Corona virus disease 2019) Covid shot reaction, blood clots in the leg and hospitalized. No treatment information was received. The outcome of the events thrombosis, immunisation reaction were reported as unknown. Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the events thrombosis and immunisation reaction. The causal relationship between the events thrombosis, immunisation reaction and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter did not and would never have access to lot number. No further information has been requested.  The reporter's assessment of the causal relationship of the events with the suspect product 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.   Company comment: This individual case report does not change the safety profile of the product. Causality Assessment to Enbrel: Thrombosis leg, Vaccination adverse reaction are unrelated to etanercept.  Enbrel is under agreement.; Sender's Comments: Based on the temporal association, a causal relationship between the events thrombosis, and immunisation reaction and Covid-19 Vaccine cannot be excluded. The events are assessed as unrelated to suspect drug etanercept. 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.
This spontaneous report as received from a registered nurse via office manager (also reported as physician) refers to a 12 month old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 08-MAR-2018, the patient was vaccinated with VARIVAX, lot # M009767, expiration date 23-FEB-2018 for prophylaxis (expired product administered). The sterile diluent (Diluent Mrk inj) (unknown lot and expiration date) used for reconstitution of VARIVAX was properly stored. The expired VARIVAX had no temperature excursions prior to being administered. No adverse effects reported. No further information provided. No PQC involved.
administration of products since onset of temperature excursion; This case was reported by a other health professional via other manufacturer and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) 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.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 31-AUG-2022 Reporter's Comments: The health care professional (HCP) called for evaluation of temperature excursion and reported the administration of other company products that were administered since onset of excursion on 10th August 2022,  IPOL (Sanofi) and Bexsero (GlaxoSmithKline).  The reporter reported that they just discovered excursion on the day of reporting. No further information, additional adverse events and product quality complaint were provided. Additional supportive information: The vaccine was administered after temperature excursion of Bexsero to the patients, which led to incorrect storage of drug.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 30-JUL-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot# N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
patient had headache, fever, arm pain the next day after vaccine but then 7 days later at 2 am she began to develop urticaria throughout body, mouth swelling and felt pressure on throat (minimal), eyes were swollen when she woke up this morning
Rash appeared at injection site on Saturday, April 3. (vaccine was administered March 22).  I noticed it when I got up that morning.  It was small, about an inch across.  Over the weekend it got larger; it is now 4 inches by 2 inches.  Not painful.  Sometimes itchy but very minor.    Just thought I should report it for recordkeeping.
Information has been received from a physician concerning a 4 to 6 year old patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (lot# not reported) and a dose of MMR II (lot# not reported). Subsequently the patient experienced "neurological effects" after receiving VARIVAX (Merck) and MMR II on the same day. At the time of this report, the patient had recovered from neurological effects. This is one of several reports from the same source. Additional information has been requested.
Pt returned to our pharmacy stating that she got the flu shot on 9/18/09 and she was concerned about a bruise on her arm and soreness/tenderness where the injection was given. She denied any signs of difficulty breathing, N/V, fever, dizziness, hives, hoarseness or wheezing. Pt did mention that bruises appeared to get smaller in size compared to day 1. Advise if she experiences any of the above mentioned symptoms to consult her physician ofc. Instructed pt to take ibuprofen with food to alleviate any pain and inflammation at the injection site.
Area was itching; Arm redness/arm erythema in the left arm 6 to 8 inches below the injection site; Minimal soreness at the injection site; sore arm; Fatigue; slept; This spontaneous case was reported by a nurse and describes the occurrence of   in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation, Pain NOS and Graves' disease. Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), APIXABAN (ELIQUIS), ACEBUTOLOL, ATORVASTATIN, FENOFIBRATE and ALPRAZOLAM (XANAX) for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        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.   On 11-Jan-2011, she had a sore arm and minimal soreness at the injection site. Between 11-Jan-2021 to 13-Jan-2021, she reported fatigue and slept. Around 18-Jan-2021, she experienced arm redness and arm erythema, in the left arm 6 to 8 inches below the injection site and reported the area was itching. The events were ongoing and no treatment was received.
Same day as the injection about 5:00 p.m. I had severe pain in my injection area of right arm.  At 7:30 p.m. I was running a temp of 100.4 (taken under my arm) . Around 8:00 -8:30 p.m. temp was 100.9. After taking 2 Tylenol extra strength my temp broke at 11:45 p.m. On 02/17/2021 I woke up unable to lift my arm over my head. I had glands swollen in my neck as well as on my collarbone. I tried heating pad compresses but that made it worse. I continued taking Tylenol  every 12 hours. 02/19/21 I was able to lift my arm again BUT it was around 03/08/2021 when I first noticed the glands in my neck were not as tender OR inflamed. I have my next shot Tuesday 03/16/2021.
PATIENT INADVERTANTLY RECEIVED THE COVID-19 PFIZER VACCINE UNDER AGE. PATIENT DENIES ANY ADVERSE REACTIONS.
Expired Dose; Initial Report Received on 08-DEC-2022  This is a spontaneous report, received from a Pharmacy Technician regarding a patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On an unknown date, a dose of HEPLISAV B (Lot #935843, expiration date 08-OCT-2022, NDC # 43528-002-01), was administered intramuscularly, route and site not specified  for hepatitis B immunisation.  The dose was reported as being expired when administered.  The reporter indicated that the patient had not reported any other adverse effects.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Pt experienced itchy red skin, swelling of arm, loss of feeling in arms (both). Entire body breaks out in bumps.
102-degree fever 1st day after the vaccine, continued low-grade fever next day with excessive aches, the third day after vaccine extreme headache and lethargy. Recovered day 4.
Itching began  about 48 hrs after injection.  Started in eyes and palms if hands but eventually spread over entire body.  Took a Claritine which gave no relief.  Calked Dr. office and they advised me to go to urgent care. Which I did.  Had the severe itching for about 3 hrs.  No difficulty breathing or swallowing.  Given IV fluids, normal saline and IV diphenhydramine ( up to 50 mg),  methylprednisone 125mg and famotidine 20mg.  Got relief quite rapidly.
Difficulty breathing 4 hours after shot (lungs and nose). some headache and dizziness
Injection site hard, warm and itching.  About 3 inches in diameter.  Not going away.
lupus, and has broken out since the second dose; lupus, and has broken out since the second dose; rash; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 27Feb2021, as dose 2, single, for COVID-19 immunisation. Medical history included ongoing lupus. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single, for COVID-19 immunisation. It was reported that, patient had lupus, and has broken out since the second dose and noticed a little bit of rash in her arm (Clarified that this was not vaccine related). She was prescribed with some steroids. The reporter asked if this would have any effectiveness on the second dose. The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Rash and the suspect BNT162B2 can be excluded.  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.
pain from the elbow to shoulder; This is a spontaneous report from a contactable consumer or other non-health care professional. A 09-decade-old (80's) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 30Jan2021 14:00 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date of Jan2021 the patient experienced pain from the elbow to shoulder. The outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. mother state child had a fever, hives, and wheezing. Hives developed on 03/04/09 around neck and shoulder.Wheezing start on Saturday 03/07/09 along with fever. Mother referred to Vaccine information sheet that was given at visit. Mother saw that these symptoms were under moderate or severe reaction and decide to take child to hospital.Benadryl was given mother states that child is fine now.
12 mo infant female with history of egg allergy. Confirmed by immunocap testing, received MMRV (ProQuad) and within 20 min developed a non pruritic, blanching rash on lower extremities more on the left leg.