chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 7.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: inadvertedley administered adult dose to 7 year old; adult Engerix-B to 7 year old; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 7-year-old male patient who received HBV (Engerix B adult) (batch number 7xy23, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th February 2022, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 7th February 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced accidental overdose and adult product administered to child. On an unknown date, the outcome of the accidental overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, on the day of reporting they inadvertedley administrated an adult dose of Engerix-B to the child patient, which led to accidental overdose and adult product administered to child. No further events were reported. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: Pediatric dose to adult patient; Pediatric dose to adult patient; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 29-year-old female patient who received HAV (Havrix pediatric) (batch number 95EJ7, expiry date 6th February 2023) for prophylaxis.   On 26th January 2022, the patient received Havrix pediatric. On 26th January 2022, unknown after receiving Havrix pediatric, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.  Additional details were provided as follows: Medical assistant reported to have administered one pediatric dose of Havrix to an adult patient, which led to accidental underdose and adult use of a child product. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: administered dose after temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 24BM2, expiry date 30th June 2022) for prophylaxis.   On 8th February 2022, the patient received FluLaval Quadrivalent 2021-2022 season. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter administered a dose of FluLaval to the patient after a temperature excursion exceeding stability information, which led to incorrect storage of drug. The reporter did not have patient information available for the adverse event. The reporter consented to follow up. Healthcare professional gave permission for the safety team to follow up.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old female patient who received HAV (Havrix) (batch number y4fl4, expiry date 28th January 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 1st February 2022, unknown after receiving Havrix and Havrix 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 details were provided as follows: The reporter stated that an expired dose of Havrix was inadvertedley administrated to the patient, which led to expired vaccine used. No further events were reported. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up. This case is linked with US2022022664, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022022664:Same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 2nd dose May2021, Shingles Oct2021/Suspected vaccination failure; Mild case of shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles in 2016 prior to being vaccinated with Shingrix).   On 16th May 2019, the patient received the 2nd dose of Shingrix. In November 2018, the patient received the 1st dose of Shingrix. On 1st October 2021, 869 days after receiving Shingrix and more than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2 doses of Shingrix in November 2018 and on 16th May 2019 and later more than 2 years after receiving 1st dose and 869 days after receiving 2nd dose the patient had another case of shingles. The patient explained this case mild and was now resolved. The patient did not remember the exact dates. The patient provided information on clinical trials as per package insert. The patient refused to provide date of birth, mailing address and health care professional information. This case was considered as suspected vaccination failure as details regarding the laboratory test confirmation for shingles were unknown at the time of reporting. The patient did not consent to follow-up.
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient got Bexsero's expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st 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.   On 8th February 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 8th February 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the Medical assistant. The age at vaccination was unknown. The reporter stated that an expired dose of Bexsero was administered to the patient, which led to expired vaccine used. The reporter consented to follow up. This case is linked with US2022023436, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022023436:Same reporter. Patient 2 of 2.
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient got Bexsero's expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA81EZ, expiry date 31st 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.   On 8th February 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 8th February 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  without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The case was reported by the Medical assistant. The age at vaccination was unknown. The reporter stated that an expired dose of Bexsero was administered to the patient, which led to expired vaccine used. The reporter consented to follow up. This case is linked with US2022023434, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022023434:Same reporter. Patient 1 of 2.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 2 years ago, 2nd dose 15Jan2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number H2PE2, expiry date 19th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 2 years ago from the day of reporting).   On 15th January 2022, the patient received Shingrix. On 15th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The Healthcare professional did not have the exact date of the 1st dose (it was given at a different pharmacy).  The reporter consented to follow up via email.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: vaccinated with expired dose; 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.   On 9th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 9th February 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with an expired dose of Bexsero, which led to expired vaccine used. No patient's details were provided. The reporter did not consent to follow-up.
Age: 0.42
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Brief resolved unexplained event, Cardiac function test, Foetal exposure during pregnancy
Clinical narrative: BRIEF RESOLVED UNEXPLAINED EVENT; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male 5 months old infant. The patient was enrolled in a non-company sponsored study. The patient's weight was 3.32 kilograms, and height was 51 centimeters. No past medical history or concurrent conditions were reported. The patient's mother had a medical history of Anxiety, Asthma, Attention deficit disorder (ADD), Attention deficit hyperactive disorder (ADHD), Depression, Endometriosis and polycystic ovary syndrome (PCOS). The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, transplacental, batch number: 0421A211A, expiry: unknown) dose was not reported, 1 total administered on 05-APR-2021 for covid-19 immunization. Concomitant medications included buspirone hydrochloride for drug used for unknown indication, escitalopram for drug used for unknown indication, ibuprofen for drug used for unknown indication, prenatal vitamins for drug used for unknown indication, omeprazole for drug used for unknown indication, and salbutamol for drug used for unknown indication. On 05-APR-2021, the patient had fetal exposure during pregnancy. In SEP-2021, Laboratory data included: Cardiac function test (NR: not provided) not reported, and Hearing test (NR: not provided) not reported. On an unspecified date, the patient had brief resolved unexplained event. On 16-NOV-2021, the patient was hospitalized. Number of days hospitalized and discharge information were not reported. No birth defects, genetic or inherited disorders had been identified since birth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 26-SEP-2021, and the outcome of brief resolved unexplained event was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and brief resolved unexplained event was related, and between covid-19 vaccine ad26.cov2.s, and fetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20210761824.; Sender's Comments: V0: 20220221367-COVID-19 VACCINE AD26.COV2.S-brief resolved unexplained event. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20220221367-COVID-19 VACCINE AD26.COV2.S-fetal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Breech presentation, Foetal exposure during pregnancy
Clinical narrative: BABY WAS IN BREECH OR ABNORMAL PRESENTATION; FETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a neonate female. The patient was enrolled in a program:  The patient's weight was 2.98 kilograms, and height was 48 centimeters. No past medical history or concurrent conditions were reported. The patient's mother received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) one total, dose was not reported, administered on 04-JUN-2021 for covid-19 immunization and patient exposed to vaccine via transplacental route (fetal exposure during pregnancy) (dose number in series 1). The batch number was not reported and has been requested. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fetal exposure during pregnancy on 23-NOV-2021. The patient's mother additionally received booster non-company suspect vaccine included: BNT 162 Pfizer-BioNTech (Comirnaty) (dose number in series 2) (form of admin, route of admin, and batch number: unknown and expiry: unknown) dose was not reported, administered on 26-OCT-2021 for covid-19 immunization and patient exposed to vaccine via transplacental route. Concomitant medications included doxylamine succinate (Unisom Sleep), famotidine (Pepcid), prenatal vitamins (4 to 6 times a week, administration route via transplacental) and paracetamol (Tylenol). On an unspecified date in NOV-2021, Laboratory data included: Hearing test (NR: not provided) Unknown. On 02-NOV-2021, the patient experienced baby was in breech or abnormal presentation (dose number in series 2). The action taken with BNT 162 was not applicable. The patient recovered from baby was in breech or abnormal presentation on 23-NOV-2021. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and baby was in breech or abnormal presentation, and fetal exposure during pregnancy was not related. This report was serious (Other Medically Important Condition). This parent/child case is linked to 20210801448.; Sender's Comments: V0: 20220221029-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Baby was in breech or abnormal presentation. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, NATURE OF EVENT. 20220221029-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fetal exposure during pregnancy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paranasal sinus discomfort, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; SINUS PRESSURE; This spontaneous report received from a patient concerned a 40-year-old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 1808982, and expiry: 21-SEP-2021) in left arm on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient received non-company booster vaccination with mrna 1273 (form of administration, route of administration were not reported, batch number: unknown and expiry: unknown) on 06-NOV-2021 for prophylactic vaccination.  On 22-JAN-2022, the patient experienced sinus pressure (dose number in series 2). On same day, he experienced headache and had suspected covid-19 infection (dose number in series 1) and suspected clinical vaccination failure (dose number in series 1). On 24-JAN-2022, the patient tested positive for coronavirus disease (Covid-19) using "Binax Now" take home antigen test. On 29-JAN-2022, the patient had a slight cough (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable (dose number in series 1). The patient recovered from sinus pressure and headache on 26-JAN-2022, and recovered from slight cough and suspected covid-19 infection on 30-JAN-2022. The outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000216251.; Sender's Comments: V0: 20220200545 -Covid-19 vaccine ad26.CoV-2.s-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: This spontaneous report received from a patient via a social media via company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: possible Covid-19. The patient previously received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unknown if the patient had adverse events after primary vaccination (dose number in series 1). The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose not reported,1 total, administered on an unspecified date for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced felt like crap. The patient mentioned had been around people in house and other places that had Covid-19. The patient thought that the patient had it before shots and after and just felt like cramp. The patient reported, "I took the J and J shot and booster only one I trust. Been around people in my house and other places that had Covid. Think I had it before shots and after. Just felt like crap" (dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt like crap was not reported. This report was non-serious. This report was associated with product quality complaint: 90000215865. Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 25 year old male. The patient's height, and weight were not reported. The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 03-APR-2021 for prophylactic vaccination. On 07-DEC-2021, the patient received non-company suspect vaccine MRNA 1273 (dose number in series: 2) ( form of admin, route of admin, and batch number were not reported) dose was not reported, administered for prophylactic vaccination. No concomitant medications were reported. On 04-JAN-2022, the patient experienced headache, congestion, fatigue, and mild fever. On 05-JAN-2022, the patient visited a clinic and had tested positive in covid-19 PCR (polymerase chain reaction) test which indicated confirmed covid-19 infection, and confirmed clinical vaccination failure (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection on 07-JAN-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint: 90000216639.; Sender's Comments: V0: 20220220752 -Covid-19 vaccine ad26.cov2.s-Confirmed clinical Vaccination  failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: blood clots. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced shingles. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000216681.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Expired product administered, SARS-CoV-2 test
Clinical narrative: This spontaneous report received from a pharmacist concerned a 52 year old White Not Hispanic or Latino female. The patient's weight was 86.7 kilograms, and height was 69 inches. The patient's concurrent conditions included: allergy to codeine and sulfa, and low back pain, and other pre-existing medical conditions included: The patient did not experience a similar event in the past. The patient was not pregnant. It was unknown whether patient had any acute illness. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 1808609, expiry: UNKNOWN) 0.5 ml, 1 total administered on 24-MAR-2021 at arm for prophylactic vaccination. No concomitant medications were reported. On 13-NOV-2021, the patient was diagnosed or tested positive for Covid-19 (Dose number in series 1) Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Covid-19 was not reported. On 24-JAN-2022 08:56, the patient received additional non-company confirmed vaccine miRNA 1273 (Dose number in series 2) (intramuscular, batch number: 070H21A expiry: UNKNOWN, form of admin was not reported) 0.25 ml, administered at arm for prophylactic vaccination. On 24-JAN-2022 08:56, the patient had expired vaccine administration (4 days beyond recommended expiration date) (Dose number in series 2). The event did not cause the patient to seek medical care. The adverse event was not most likely caused by miRNA 1273. There were no any other potential causes. The patient recovered from expired vaccine administration on 24-JAN-2022. This report was non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Otoplasty, Rheumatoid arthritis, Suspected COVID-19, Vaccination failure
Clinical narrative: EAR ISSUE SURGERY/RECONSTRUCTIVE AND REMOVAL SURGERY ON LEFT EAR; RHEUMATOID ARTHRITIS FLARE UP; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch or lot number. Non-company suspect drugs included: upadacitinib (form of admin unknown, oral, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported.  On an unspecified date in June 2021, the patient experienced COVID. On an unspecified date in AUG-2021, the patient had experienced covid (suspected covid-19 infection) and on an unspecified date in NOV-2021, the patient experienced the covid for the third time and had recovered from it. He also had strep throat at the same time of covid in NOV-2021.  On an unspecified date in JAN-2022, the patient had experienced rheumatoid arthritis flare up and she was treated with steroid. On an unspecified date, the patient experienced ear issue surgery/reconstructive and removal surgery on left ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The action taken with upadacitinib was not reported. The patient recovered from ear issue surgery/reconstructive and removal surgery on left ear, and suspected covid-19 infection, was recovering from rheumatoid arthritis flare up, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint and reference number: 90000216853.; Sender's Comments: V0:20220222629-COVID-19 VACCINE AD26.COV2.S-Rheumatoid arthritis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20220222629-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Neoplasm progression, Vaccination complication, Weight decreased
Clinical narrative: TUMOR GROWING ON THE TRIGEMINAL NERVE; REACTED TO VACCINE; MISERABLE; LOST A LOT OF WEIGHT; NUMBNESS ON ONE SIDE OF FACE; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. Patient went from a perfectly healthy active person to a miserable man. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced tumor growing on the trigeminal nerve, reacted to vaccine, miserable, lost a lot of weight, and numbness on one side of face. The reporter stated that, "My husband reacted to the Johnson and Johnson vaccine when we first received it. A few months later he woke up with numbness on one side of his face. Not a stroke he has a tumor growing on the trigeminal nerve. He went from a perfectly healthy active person to a miserable man. He has lost a lot of weight. We now need to find a neurosurgeon to see what treatment is available". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tumor growing on the trigeminal nerve, and the outcome of reacted to vaccine, numbness on one side of face, lost a lot of weight and miserable was not reported.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220224199-Covid-19 vaccine ad26.cov2.s-Tumor growing on the trigeminal nerve. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: This spontaneous report received from a patient via social media via a company representative concerned a 90 year old of unspecified sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received Covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of Covid-19 vaccine ad26. cov2.s. (dose number in series 1). The patient received booster Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number: unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced very little red at the injection shot (dose number in series 2). It was posted that "I am 90 years old has all the shots and booster never had any reaction to any except for a very little red at the injection shot." The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very little red at the injection shot was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had medical problem with needles. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, after less than four months of vaccination the patient experienced suspected covid-19 infection, and thought that vaccine was ineffective (suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). The report was associated with product quality complaint number: 90000216796.; Sender's Comments: V0: 20220224665- covid-19 vaccine ad26.cov2.s -Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication, Wheelchair user
Clinical narrative: WHEELCHAIR-BOUND; VACCINE INJURY; This spontaneous report received from a patient via a company representative concerned an 18 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced wheelchair-bound, and vaccine injury. It was reported that healthy patient was wheelchair-bound after devastating Johnson and Johnson vaccine injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wheelchair-bound and vaccine injury was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220224734-covid-19 vaccine ad26.cov2.s-wheelchair-bound, vaccine injury. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 0.17
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Haemoglobin
Clinical narrative: NOSE BLEED; This spontaneous report received from a patient concerned an 81-year-old female. 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: 211D21A, and expiry: 11-APR-2022) dose was not reported, 1 total, administered at right arm on 06-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On 09-JAN-2022, patient experienced nose bleed and called 911, ambulance came and transported her to the ER (emergency room). The hospital kept her overnight and the treatment was packing in both nostrils and was put on put on Cephalexin 250mg 1 capsule by mouth four times daily for 5 days. The patient was released from hospital on 10-JAN-2022, the patient hospitalized for 2 days and was advised to call 911 immediately, if the event recur. The packing was left in for 5 days, the packing was removed by ENT (ears, nose and throat) on 14-JAN-2022. The patient stated it occurred again on 17-JAN-2022, 911 call was placed and the patient was taken to the hospital emergency room via ambulance. She was not admitted and the hospital administered packing on the right side of her nostril. This remained for another 5 days, removed on the 21-Jan-2022 by doctor from ENT and the doctor also catharized her right nostril. The patient stated that it seems to start on both sides and blood also comes out of the mouth. The patient also reported that her hemoglobin dropped to 10.3 (units unspecified) on 10-JAN-2022. The nose bleed occurred again on 26-JAN-2022 with another 911 call placed and was taken to the emergency room. The treatment consisted of no packing. The patient was sent to ENT (after 5-hour emergency room stay). The patient saw doctor and was catharized again and was sent consumer home. The 4th occurrence was on 02-FEB-2022. The patient was able to stop the bleeding herself and went to the ENT immediately. Doctor did catharized the right nostril again which led to bleeding then she had to have balloon packing. The patient was started, again on Cephalexin 500mg 1 capsule by mouth twice daily for 5 days. The balloon packing was removed 08-FEB-2022 and was replaced with a soluble packing that will dissolve on its own. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nose bleed. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220224843-covid-19 vaccine ad26.cov2.s-Nose bleed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous report received from a patient concerned multiple patients. No medical history, concurrent conditions or concomitant medications reported. The patient received the COVID-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch/lot# unknown/not reported), start therapy date not reported, for immunization. Per procedure no follow-up will be requested for this case. On an unspecified date, patients contracted COVID-19, with outcome of recovered. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Feeling cold, Headache, Illness
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced terribly sick, lightheaded, bones felt like ice with four layers of clothes and a heating pad and three blankets, 104 F. fever for three days, terrible headache, and nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104 F. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terribly sick, 104 F. fever for three days, bones felt like ice with four layers of clothes and a heating pad and three blankets, terrible headache, nausea and lightheaded was not reported. This report was non-serious. This report was associated with product quality complaint 90000217062.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced terribly sick, lightheaded, bones felt like ice with four layers of clothes and a heating pad and three blankets, 104 F. fever for three days, terrible headache, and nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 104 F. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terribly sick, 104 F. fever for three days, bones felt like ice with four layers of clothes and a heating pad and three blankets, terrible headache, nausea and lightheaded was not reported. This report was non-serious. This report was associated with product quality complaint 90000217062.
Age: 0.08
Sex: M
Vaccine: COVID19
Symptoms: Laryngomalacia
Clinical narrative: Laryngomalacia; This spontaneous case was reported by a consumer and describes the occurrence of LARYNGOMALACIA (Laryngomalacia) in a 1-month-old male infant exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the mother received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Hypertension, Maternal exposure during pregnancy and Ultrasound abdomen on 23-Oct-2020.    No Medical History information was reported.    On 30-Dec-2020, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The mother's last menstrual period was on 25-Aug-2020 and the estimated date of delivery was 13-Jun-2021. In July 2021, the infant was diagnosed with LARYNGOMALACIA (Laryngomalacia) (seriousness criterion medically significant). The Infant was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighteenth week of the pregnancy. The vaginal delivery occurred on 09-Jun-2021, which was reported as Full-term. For neonate 1, the birth weight was 108472 grams (239lbs 3oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. The fetal weight was 3827 grams with length as 53.34 and head circumference as 34.8. At the time of the report, LARYNGOMALACIA (Laryngomalacia) outcome was unknown.        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.   No concomitant medications reported.  No Treatment medications was provided by the reporter.  The patient's mother had normal ultrasound on 23-Oct-2020, 15-Jan-2021, 19-Mar-2021 and 13-May-2021. On 20-Mar-2021, the patient glucose for one hour.   The patient's mother gestation period was 39.  Company Comment:   This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.   This case was linked to MOD-2021-272273 (Parent-Child Link).   See case MOD-2021-272273 for details regarding the Parent case.  Most recent FOLLOW-UP information incorporated above includes: On 04-Jan-2021: No specific follow-up information recorded. On 01-Aug-2021: Follow up information was received: The additional reporter (Physician) and pregnancy outcome report added.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (She has been breastfeeding) in a patient of an unknown age and gender exposed to mRNA-1273 (Moderna COVID-19 Vaccine), while the mother received the product for COVID-19 vaccination. MEDICAL HISTORY (Parent): maternal exposure during breastfeeding. No Medical History information was reported. On 07-Jul-2021, the mother received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Aug-2021, the patient was diagnosed with EXPOSURE VIA BREAST MILK (She has been breastfeeding). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 07-Aug-2021, EXPOSURE VIA BREAST MILK (She has been breastfeeding) had resolved. This case was linked to MOD-2021-283789 (Parent-Child Link). See case MOD-2021-283789 for details regarding the Parent case.