chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; Vaccination failure; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe).   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Daily dose: Citrate free, Solution for injection in prefilled pen. On 15-Oct-2021, the patient experienced COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure). At the time of the report, COVID-19 (COVID-19) had resolved and VACCINATION FAILURE (Vaccination failure) outcome was unknown.            Concomitant Drugs were not reported. On 15-Oct-2021, the patient experienced COVID-19. In 2021, the COVID-19 had resolved. No treatment information was provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment-This spontaneous case concerns a male patient aged 42 years with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 that occurred 148 days after the second dose of mRNA-1273 vaccination. Additionally, Vaccination failure was also noted. The time interval between first and second dose of mRNA-1273 vaccine was 30 days. No further information on detailed clinical course, investigations, treatment of the events was available in the report.  Outcome of the event was resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient aged 42 years with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19 that occurred 148 days after the second dose of mRNA-1273 vaccination. Additionally, Vaccination failure was also noted. The time interval between first and second dose of mRNA-1273 vaccine was 30 days. No further information on detailed clinical course, investigations, treatment of the events was available in the report.  Outcome of the event was resolved at the time of report. Current pandemic situation of COVID 19 may remain as confounders to the event Covid -19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness(non-serious) assessed as per medical judgement..
second dose of Moderna vaccine 21 days after the first dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna vaccine 21 days after the first dose) in a male patient of an unknown age who received mRNA-1273 (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna vaccine 21 days after the first dose). On 29-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna vaccine 21 days after the first dose) had resolved.        For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not provided. Concomitant medication not provided,
Severe lip pain, redness, burning, swelling, cracking in corners, and peeling.  Nasal fissures and ulcerations. Raw, irritated throat.  Headaches, light sensitivity, wheezing. I first saw my rheumatologist on 9-20-2021 who suggested I see dermatology. I saw dermatology on 9-22-2021. Derm prescribed a prednisone burst consisting of 40 mg  prednisone daily x 3 days, 30 mg prednisone daily x 3 days, 20 mg prednisone daily x 3 days, and 10 mg prednisone daily x 3 days. In addition, derm prescribed, Fluticasone 0.005% ointment to be applied to lips. I have had to increase my use of my albuterol MDI and continue to have wheezing.
Fever; Drowsiness; Hives; Pain in my hands; Pain in feet; This is a spontaneous report from a contactable consumer. A 15-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 10Sep2021 at 17:00(at the age of 15-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other vaccines within two weeks of the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on unknown date, as a single dose for COVID-19 immunisation.  The patient had known allergy to ZOFRAN. On 25Sep2021 at 10:00,  the patient experienced fever, drowsiness, hives, pain in hands and feet. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken for the treatment of these adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever, drowsiness, hives, and pain in hands and feet was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Injection administered; pt grabbed at needle with hand. Pt did not get hurt; no skin punctured but vaccine was wasted. Pt had tiny scratch on left leg from needle. Vaccine readministered.
Pt recvd MMR vax; w/in 30 min of receiving vax, pt devel swollen lips & generalized hives; Tx Epi,  DPH;
GASTRO-INTESTINAL PROBLEMS; VOMITING; NUMBNESS FROM THE WAIST DOWN; FATIGUE; This spontaneous report received from a patient concerned a male 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: not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced gastro-intestinal problems, vomiting, numbness from the waist down, and fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test negative (NR: not provided) NEGATIVE. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, gastro-intestinal problems, vomiting and numbness from the waist down was not reported. This report was non-serious.
Pt received injection, then collapsed, with no memory of event.  Pt was unresponsive approximately 15 seconds.  HR 52 & irregular, BP 110/80
This spontaneous report as received from a physician, via a company representative, refers to an approximately 76 years old male patient. Information about the patient's medical history and concurrent conditions was not provided. Approximately in 2011 (reported as "about 4 years ago"), the patient was vaccinated with a dose of ZOSTAVAX (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The patient was seen in the physician office "about 1 week ago", on approximately 11-SEP-2015, due to an outbreak of shingles. The outcome of herpes zoster was reported as not recovered at the time of this report. The reporter did not provide a causality relationship assessment between the event and vaccination with ZOSTAVAX. Additional information is not expected, since there is no consent to contact the physician.
Mild superficial cellulitis of right thigh approximately 4 cm diameter, blanching, noted 7d after vaccine. Pt started on PO cephalexin, topical BACTROBAN.
fever; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and HEADACHE (headaches) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (fever) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Fever, at an unspecified dose and frequency. On 04-Mar-2021, PYREXIA (fever) and HEADACHE (headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 antibody test: high (High) greater than 2500.         Patient had both doses of the Moderna COVID-19 and had a bad reaction after the second shot (which she think on 03-Mar-2021). She had fever and headaches but as she expected them she did not report them. By the next day she was fine, the symptoms lasted one day. She would like to know if she should take the booster shot.  Concomitant medication use was unknown
Patient reports he received the vaccine to the LUE, in the subcutaneous tissue to back of upper arm. He did have redness, tenderness and pain at site for the last 3 days. Symptoms are starting to improve today. Patient denies any numbness/tingling to upper extremitiey. He denies any fevers, or body aches. He denies any joint pain. He does not have any swelling at site. He has full range of motion to LUE
Increased heart rate at irregular time . Mostly felt it during rest hours or while trying to sleep or in mid of sleep. Heart rate goes up for few minutes and then becomes normal. At such times, can feel the heart is pumping and makes body shake automatically.
patient develop severe bruising not caused by trauma a few weeks after vaccine. Went to urgent care and PCP, they all couldn't determine what is the cause.  later was hospitalize due to low hematocrit showing up on a recently labwork in january 2023 and was given blood transfusion. discharged because they  could not determine what the cause was but ruled out internal bleeding.  Went again to the hospital a few weeks later for low hematocrit and blood pressure, Diagnosed with acquired hemophilia, then passed away shortly after diagnosis.  never had any other autoimmune situation before and no recent medicine change.
(1) One day after vaccination, swelling, redness, itchy & hot area at site of injection - Tennis ball size - lasted 1 week Rx with ice - improved every day. (2) 3 days after vax, noted 3 "welts" around (L) wrist, very itchy & raised. Quarter & dime sized areas, still present after 5 days but resolving.
This spontaneous report was received from a registered nurse and refers to a 8 week old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On 03-JAN-2019, the patient was vaccinated with improperly stored doses of ROTATEQ lot # R002516, expiration date 13-SEP-2019, orally, (dose and frequency were not reported) for prophylaxis; and RECOMBIVAX HB lot # R004185, expiration date 06-NOV-2020, intramuscularly (dose and frequency were not reported) for prophylaxis.  The improperly stored vaccines were stored at a temperature of 0.6 Celsius degrees (C) (also reported as "below 36 fahrenheit degrees/2 C") for 53 hours. The call was made because of a data logger. There were no previous temperature excursions (it was also mentioned that there were multiple excursions (discrepant information). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of 2 reports received from the same reporter (MARRS # 1901USA005733).; Sender's Comments: US-009507513-1901USA005733:
expired dose of shingrix was administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (expiry date NOV-2022) for prophylaxis.   On 05-JUN-2023, the patient received Shingrix. On 05-JUN-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: expired dose of shingrix was administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-JUN-2023 The Vaccine Administration Facility was the same as Primary Reporter. No other information was available. The reporter consented to follow up.  The reporter reported that an expired dose of Shingrix was administered to patient, which led to expired vaccine used.
Day 10 after first dose developed pruritic, slightly erythematous,, slightly elevated discoid rash at injection site 2X2 inches in diameter.  Now a little worse on day 13 post vaccine. No fever, no LAN, no myalgias.
Information has been received on 11-SEP-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 11-JUN-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a hospital as recommended for routine adult health maintenance for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2012, the patient was treated at the same hospital for the onset of a severe a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of vomiting in a 18-year-old female patient who received BEXSERO. Concomitant products included MENACTRA. On an unknown date, the patient received BEXSERO. On an unknown date, several hours after receiving BEXSERO, the patient experienced vomiting, fever and dizziness. On an unknown date, the outcome for the vomiting, fever and dizziness were unknown. It was unknown if the reporter considered the vomiting, fever and dizziness to be related to BEXSERO. Additional details were provided as follows: The reporter stated that, the patient received BEXSERO in one arm and MENACTRA the other arm.
Shoulder pain began 6 hours after vaccination, ibuprofen helped in the beginning then it did not.  Steroid injections and Physical Therapy performed. Next surgery to reduce inflammation.
Breakthrough case admission after three vaccines Moderna 2/23/21 Lot# 007M20A;  Moderna 3/23/21 Lot#015M20A;  Moderna 11/4/21 Lot# 005C21A
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given 10 doses from one vial 2 days past the 30 day expiration window) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 08-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given 10 doses from one vial 2 days past the 30 day expiration window). On 08-May-2021, EXPIRED PRODUCT ADMINISTERED (Given 10 doses from one vial 2 days past the 30 day expiration window) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Parents noticed redness to right side of neck/shoulder area that radiated partially down back. Tried hydrocortisone OTC cream with no improvement. Parents took child to ER where he was given BENADRYL cream and BENADRYL PO.
blood clots; heart attack; migraine, a definite link between the protein spike from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) and MYOCARDIAL INFARCTION (heart attack) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant), MYOCARDIAL INFARCTION (heart attack) (seriousness criterion medically significant) and MIGRAINE (migraine, a definite link between the protein spike from the vaccine). At the time of the report, THROMBOSIS (blood clots), MYOCARDIAL INFARCTION (heart attack) and MIGRAINE (migraine, a definite link between the protein spike from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided by the reporter.  Company comment: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt found in crib not breathing 6 or 7AM; death ruled SIDS-autopsy done;
The 14 year old patient received the Pfizer BioNTech Vaccine; this vaccine is not authorized for use in individuals less than 16 years of age.
Severe anxiety reaction ( panic attack, beginning about 1 hour later. Feelings of anxiety, agitation, fears, symptoms gradually resolved over about 10 hours. Seen by Emergency Mental Health Counselor.
Mom states right arm, post vax, had increased redness and warmth to touch. Some itching noted (+) diarrhea. Benadryl given at 09:00 AM on 05/10/2000. On 5/12/2000, seen by doctor, improvement noted with no redness or swelling.
hearing loss/high frequency hearing loss; ringing of her ears; everything sounds muffled and silenced; Greater than 35 days since the patient received her First Moderna Covid-19 vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss/high frequency hearing loss), TINNITUS (ringing of her ears), HYPOACUSIS (everything sounds muffled and silenced) and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient received her First Moderna Covid-19 vaccine.) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS (hearing loss/high frequency hearing loss) (seriousness criterion medically significant), TINNITUS (ringing of her ears) (seriousness criterion medically significant), HYPOACUSIS (everything sounds muffled and silenced) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient received her First Moderna Covid-19 vaccine.) (seriousness criterion medically significant). At the time of the report, DEAFNESS (hearing loss/high frequency hearing loss), TINNITUS (ringing of her ears) and HYPOACUSIS (everything sounds muffled and silenced) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days since the patient received her First Moderna Covid-19 vaccine.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Acoustic stimulation tests: abnormal (abnormal) lost half of high frequency hearing; low frequency hearing within range. In June 2021, Acoustic stimulation tests: approaching normal (Inconclusive) high frequency hearing getting better; ringing in ears improving.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Gave 4 month vaccines, Kept in office for 10-15minutes. Mom left with child. Arrived home and called back to office states has broke out in rash. Instructed to return to office, Child has welp and red blotches to face and neck. Urticaria.
Patient received 1st dose at ~9am on 7/20/21, Was very dizzy and nauseated, she states her lips, toes and fingers felt very tingly within hours of vaccine. She then stated that she got very disoriented and couldn't speak and then had a seizure. EMS was called and she was taken to the hospital and was admitted for observation, I made F/U call and patient seemed to be doing well, but was still admitted and stated she was told she would be there a couple of days.  She was at work after receiving the vaccine when these events took place.