chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (her sister died after the 2nd Moderna vaccine/ cardiac arrest) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The patient's past medical history included COPD and Emphysema. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (her sister died after the 2nd Moderna vaccine/ cardiac arrest) (seriousness criteria death and medically significant). The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. It was reported that patient died after the 2nd Moderna vaccine, she went into cardiac arrest and died several hours later. Patient was transferred to the closest hospital where she was pronounced. No treatment medication were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This fatal spontaneous case concerns a female of unknown age, with no medical history reported, who received the second dose of her COVID19 immunization schedule with mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected event of cardiac arrest. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The reporter mentioned the patient went into cardiac arrest and died several hours later. No further information regarding the event, death date and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. The benefit risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This fatal spontaneous case concerns a female of unknown age, with no medical history reported, who received the second dose of her COVID  19 immunization schedule with mRNA-1273 vaccine (unknown schedule) and experienced the serious unexpected event of cardiac arrest. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The reporter mentioned the patient went into cardiac arrest and died several hours later. No further information regarding the event, death date and cause of death have been provided for medical review. It is unknown whether an autopsy was performed. The benefit risk relationship of mRNA-1273 is not affected by this report. Reported Cause(s) of Death: Cardiac arrest.
"A company representative reported that a 4 month old received vaccines on 8/23/00. That evening, the infant developed a seizure. Seizures are considered "Medically Important".
I experienced unusual never felt before Pain in middle of chest lasted approx.3-5 minutes (possible rapid heart rate event) 1 and 1/2 hr. after Moderna vaccine given on 1/12/2021 no more pain after that event. She suggested it might have been a rapid heart rate and to go to doctor to get it checked out. I hope I am filling this form out correctly. I intend to get checked out by doctor soon.
Hives on buttocks, genital area, and both legs; no fever; itching.
- 12/10/09: patient received Tdap - 12/11/09: patient developed fever >101 and chills - 12/12/09: patient developed R arm swelling, spreading down the arm
My 15 year old daughter got her 1st Pfizer Shot, and then tested positive for COVID19, fell Ill, Lost weight, missed her finals, and is still sick, due to this shot!; fell Ill; Lost weight; missed her finals, and is still sick, due to this shot!; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SARS-COV-2 TEST POSITIVE (non-serious), outcome "unknown", described as "My 15 year old daughter got her 1st Pfizer Shot, and then tested positive for COVID19, fell Ill, Lost weight, missed her finals, and is still sick, due to this shot!"; MALAISE (non-serious), outcome "unknown", described as "fell Ill"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Lost weight"; ILLNESS (non-serious), outcome "unknown", described as "missed her finals, and is still sick, due to this shot!". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Polyarticular Juvenile Idiopathic Arthritis Flare Up In Both; This is a solicited report based on the information received by Pfizer (Mfr. Control No.:21K-163-4100177-00). A contactable 19-year-old female consumer (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 19Feb2021 (at a age 19-year-old), as dose 1, single and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 12Mar2021 (at 19-year-old), as dose 2,single for COVID-19 immunization and adalimumab (Humira) at an unknown dose via subcutaneous route for Moderate to severe polyarticular juvenile idiopathic arthritis. The patient's medical history and concomitant medications were not reported. On an unknown date the patient experienced polyarticular juvenile idiopathic arthritis flare up in both knees and hips. The event outcome was unknown.    The reporter assessed the causality for BNT162B2 as probably and of adalimumab as no reasonable possibility with the event, 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.  No follow-up attempts were possible, information about lot/batch number could not be obtained.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Juvenile idiopathic arthritis and suspect drug BNT162B2 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.
Slightly elevated ast and alt. 2 days after shot had extreme debilitating fever , messes,  Sweating, severe diarrhea, nausea, no taste, for 18 days. Now. Weakness, no energy
The patient received a J&J vaccine at 3pm, being observed for 30mins after the dose. Around 325pm, patient stated that she felt like something was stuck in her throat.  Clinic RN reported she had none of the following:  angioedema, swelling,  SOB, CP.  VSS. SBP 120s Sp02 98% RA.  Patient was walked to ER for precaution checkout, confirmed negative for angioedema, patent oropharynx, A/O x3 with unclear etiology.  Benign PE and VSS.    Patient received dexamethasone 12mg PO X1. and famotidine 20mg x1 then BID x3 days, and was discharged uneventfully at 17pm on that day.
Patient indicated on admin form his age is 50 years old. Upon processing vaccination after patient had left, it was discovered this patient is only 49 years old. No indication on form or discussion with vaccinating pharmacist about immunocompromise. Therefore,  given outside of current guidelines. No current clinical issues known due to early vaccination.
Small hematoma at injection site with 2 small hives, turned into a deep, dark bruise.  Has been itching since receiving the injection and arm soreness has continued through today.
States had Moderna booster on Friday, 11/19/2021 at Health Department. States went to Urgent Care on 11/24/2021 due to "fluttering in heart, fever, heartburn, and terrible headache." Completed two EKG's and was notified that she had PVC's & HTN. States BP was 168/98 & states has no hx. of BP issues. States was not given any medication, kept her for a few hours & then told her to contact us to report heart issue with COVID vaccination. Facility encouraged her to rest, hydrate, & reduce any nearby stressors. States as of today, 11/29/2021, is having low-grade fever & occasional "heart fluttering." States if it doesn't get any better, she will go to PCP tomorrow states never experienced these symptoms with any other vaccines
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: EL9266), in left arm, on 12Mar2021 as dose 2, single (Lot number: EN6209), in left arm and on 18Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "triglycerides" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol increased. 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 results. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid 300-100mg (Lot number: 00069-1085-30) from 04Jun2022 to 09Jun2022.
about an hour and a half after the injection I noticed my heart was beating very fast and hard.  it was waking me up at night due to the pounding.   It has remained this way since i have had the injection on Dec 30, 2020.
Stomach went (bad belly) totally exhausted to point I couldn't get up, chills, fever, sharp body aches...took tylenol,..happy to say I felt somewhat better by 9 pm
Temp 103F(R); 3rd DTP; Seen by MD 21JUL90 was more alert & playing; No hx of allergies, no problem w/previous vax, no family hx available;
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant therapies were not reported. On 26-MAR-2019, the patient was vaccinated with VARIVAX (dose, dose number, route of administration and anatomical site of vaccination were not reported; lot # R006220 and expiration date on 29-FEB-2020) and with PROQUAD (dose, dose number, route of administration and anatomical site of vaccination were not reported; lot # R015739 and expiration date on 02-DEC-2019) (product administration error); both administered for prophylaxis. The vaccines were administered with an sterile diluent. No adverse effect reported.
Pt received first dose of vaccine, while he was waiting in observation for his 15 minutes he was seen slumping over and the nurse approached him. He said he did not feel good and the paramedics took him outside to assess him. His BP and HR were abnormal and they decided to take him to a nearby hospital. Before he was transported he said before the shot he smoked weed and did not eat.
pt recv vax 30OCT95 & 6NOV95 exp fussiness & fever of 102 which responded to APAP;pt recovered from fussiness & fever on the same day;
Received Flu vaccine in November. On 1/19, patient went home, took a nap and woke up 30 minutes later with severe pain on left shoulder. Pain was severe to the point of crying. If lift arm too high it hurt really bad; couldn't sleep on it either. Called doctor that day and went in and was given ice packs by nurse. Put ice packs but did not help at lot. Patient has not gone back yet to doctor; has appointment on 2/17, for possible blood cloth on leg. The pain at this point is mild and there is no visible swelling at injection point. Started taking VICTOZA med the day after vaccination.
At 1021, patient was given 0.3 mL of Pfizer vaccine mixed with 1.4 mL NS (instead of 1.8 mL) IM on left arm.  Patient is bedbound and was given the vaccine at home.  Patient was observed for 30 minutes and did not have any symptoms during the observation period.  Patient's caregiver was given details of event and info about responding to adverse reactions  when a healthcare professional is not present.
as per patient, first flu shot. does not remember if she received in the past as a child. as per patient, received Afluria 20-21 preservative free flu shot on 11/18/2020 around 6:30pm. 2 hours later, patient experienced swelling of glands, jaw, tongue, wheezing, eyes burning (could not open or close), racing heart, chills. had difficulty sleeping at night. woke up in morning 11/19/2020 with migraine. by 11/19/2020 around noon, all symptoms resolved or went away. patient confirmed not allergic to eggs.
Pt developed generalized urticaria within 24 hrs of vaccine administration. He had no dysphagia, dyspnea or mucous membrane involvement.
lower eyelid has been rapidly twitching after the vaccine for the past 8 days.  it started about three hours after receiving does.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Apr2021 17:15 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SERTRALINE. The following information was reported: BLEPHAROSPASM (non-serious) with onset 25Apr2021 20:15, outcome "not recovered", described as "lower eyelid has been rapidly twitching after the vaccine for the past 8 days.  it started about three hours after receiving does.". The event "lower eyelid has been rapidly twitching after the vaccine for the past 8 days.  it started about three hours after receiving does." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of blepharospasm. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Patient contracted COVID after being fully diagnosed on 9/14/2021 with Shortness of breath and sore throat.
PT WITH HX BILAT MASTECTOMY WANTED VACCINE IN HER THIGH. GIVEN IN THE RIGHT THIGH WITHOUT ISSUE.
Pain reappeared at injection site about 10 days after injection.  Pain radiated upward towards neck and was red and hot and there was swelling in my neck area, as well for 2 full days.  Pain in neck area has since gone away, but there is still ongoing pain at the injection site.  Daily headaches, nausea and sever fatigue,  have been ongoing since the pain has come back.  These symptoms are still happening.
Very sore arm; rash on my thigh that was also tender; fever of 102.4; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non - pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the left arm on 10Mar2021 at 07:30 (at the age of 71-years- old) as a single dose for COVID-19 immunisation. The patient medical history was reported as immunocompromised, COPD, Rheumatoid arthritis (RA) and osteoporosis. The patient had allergies to ceclor and iodine. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN), CELEBREX , vitamins (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) for unknown indication from unknown date . Prior to the vaccination, the patient was not test positive for COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021, the patient experienced very sore arm, painful rash and  fever of 102.4. It was reported that Firstly, the patient was immunocompromised and other than a very sore arm she had no other event until a week later. Then she developed a rash on her thigh that was also tender and a fever of 102.4. By the next day the fever was down to normal but the rash and tenderness remain.  The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events sore arm, painful rash and fever was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a nurse concerning a 4 year old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with one dose of VARIVAX lot # N008077, expiry date 09-MAR-2019, subcutaneously for prophylaxis, following temperature excursions of -12.3 Celsius degree for 30 minutes and -9.8 Celsius degree for 3 hours 30 minutes (product storage error). A data logger was involved. No adverse effect was report. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA010721: US-009507513-1711USA010722: US-009507513-1711USA010723: US-009507513-1711USA010724: US-009507513-1711USA010725: US-009507513-1711USA010726: US-009507513-1711USA010727: US-009507513-1711USA010728: US-009507513-1711USA010729: US-009507513-1711USA000697:
Turned pale & vomited & had BM 4 hrs after receiving. Became unresponsive PENTACEL & PREVNAR & Rotavirus vaccine on 11/22/11.
severe cramps, diarrhea for 72hr 101 fever for first 12hr p/vax;
pt recv vax 20OCT96 & lab eval on 19NOV96 revealed a lack of seroconversion;
hives; itching; mild fever; was achy; This non-serious case was reported by a consumer and described the occurrence of fever in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus.   On 20-JUL-2023, the patient received Shingrix. On 21-JUL-2023, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: mild fever) and pain (Verbatim: was achy). On 23-JUL-2023, the patient experienced hives (Verbatim: hives) and pruritus (Verbatim: itching). The patient was treated with benadryl (nos) (Benadryl). The outcome of the fever and pain were not reported and the outcome of the hives and pruritus were not resolved.   It was unknown if the reporter considered the fever, pain, hives and pruritus to be related to Shingrix.     It was unknown if the company considered the fever, pain, hives and pruritus to be related to Shingrix.   Additional Information: GSK receipt date: 25-JUL-2023 The patient received the vaccine last Thursday and on Friday he was achy all over and had a mild fever.  The patient still felt achy on Saturday in a tiny bit on Sunday and Sunday night around 10:00, he started itching, went to get his shower took shirt off and saw all the hives.  The patient stated that they came on all of a sudden.  The patient took Benadryl per an online visit with a physician and they had subsided by morning.  The patient stated that again last night about the same time the hives reappeared and were itchy, not as numerous but still there.  The patient stated that his only assumption was it was from the vaccine he received. The patient never had hives ever in his life until then, he just wanted to report it. The reporter gave permission to contact them.
my 2nd Moderna vaccination. I missed it.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (my 2nd Moderna vaccination. I missed it.) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (my 2nd Moderna vaccination. I missed it.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (my 2nd Moderna vaccination. I missed it.) outcome was unknown.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.
a HCP administered an Ipol vaccine to the patient that hadexpired, No AE; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12 month old patient of unknown gender who received an expired dose of IPV (VERO) [IPOL] VACCINE (lot N1K931M, Exp. Date 18-NOV-2019) via unknown route in Right Vastus Lateralis on 20-Nov-2019.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); HIB VACCINE CONJ (TET TOX) (ACTHIB) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  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.
got the shot, shingles / suspected vaccination failure; shingles; it hurts; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient got the shot to but he had shingles and it hurts. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required