chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; GARDASIL 9 had involved in multiple low temperature excursion and was administered; This spontaneous report has been received from a medical assistant referring to a 14 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) had been involved in multiple low temperature excursion of 35 degree  Fahrenheit(F) for 0.25 hour (on 03-NOV-2021), 0.75 hour(on 04-NOV-2021), 0.5 hour(on 05-NOV-2021) and 0.25 hour(on 12-NOV-2021), respectively. The previous excursions were unknown. On 12-NOV-2021, the patient was vaccinated with the improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(lot # T030749, expiration date 16-MAR-2023; strength, dose, frequency, route and anatomical location were not reported) for prophylaxis(product storage error). No additional adverse event (AE) was reported, and no further information provided.
Age: 0.75
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; RECOMBIVAX HB had been involved in multiple low temperature excursion and was administered; This spontaneous report has been received from a medical assistant referring to a 9 months old patient of unknown gender. The patient's medical history, concurrent condition and concomitant medication were not provided.  Hepatitis b vaccine (recombinant)(RECOMBIVAX HB)had been involved in multiple low temperature excursions on 03-NOV-2021(35 degree Fahrenheit(F) for 0.25 hour), 04-NOV-2021(35 F for 0.75 hour), 05-NOV-2021(35 F for 0.5 hour), 12-NOV-2021(35 F for 0.25 hour), 15-NOV-2021(35 F for 1.5 hour), 16-NOV-2021(33 F for 4.25 hour), 17-NOV-2021(34 F for 2.25 hour) and 18-NOV-2021(34 F for 1.25 hour), respectively. The previous excursions were unknown.  On 19-NOV-2021 the patient was vaccinated with the improper storage hepatitis b vaccine (recombinant)(thimerosal-free)(RECOMBIVAX HB) (lot # T028933, expiration date 03-NOV-2022; strength, dose, frequency, route and anatomical location were not reported) for prophylaxis(product storage error). No additional adverse event (AE) was reported, and no further information provided.
Age: 13.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; GARDASIL 9 had been involved in multiple low temperature excursion; This spontaneous report was received from a medical assistant referring to a 13 years old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 22-NOV-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # T030749, expiration date 16-MAR-2023) after temperature excursion for prophylaxis (product storage error). The vaccine had been involved in multiple low temperature excursion: 35 F for 0.25 h on 03-NOV-2021, 35 F for 0.75 h on 04-NOV-2021, 35 F for 0. 5 h on 05-NOV-2021, 35 F for 0. 25 h on 12-NOV-2021, 35 F for 1. 5 h on 15-NOV-2021, 33 F for 4. 25 h on 16-NOV-2021, 34 F for 2. 25 h on 17-NOV-2021, 34 F for 1. 25 h on 18-NOV-2021, 34 F for 0. 25 h on 22-NOV-2021. No adverse event was reported.
Age: 1.08
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: had been involved in multiple low temperature excursion between dates of 11/3/2021 and 11/24/2021; no adverse event; This spontaneous report was received from a medical assistance and refers to a 13-month-old patient.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.   On 03-NOV-2021, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot # S036818 with the expiration date of 22-APR-2022, (exact dose number, route and site of administration were not reported) for prophylaxis. Haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) had been involved in multiple low temperature excursion between 03-NOV-2021 and 24-NOV-2021 (storage product error).  The patient did not experience any adverse events (no adverse event). This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA003598: US-009507513-2112USA003534: US-009507513-2112USA003530: US-009507513-2112USA003546:
Age: 0.75
Sex: F
Vaccine: HPV9
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: No additional AEs were reported; 9 month old patient received GARDASIL 9; This spontaneous report was received from a medical assistant and refers to a 9-month-old female patient.No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.    On 08-DEC-2021, the patient of inappropriate age was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dosage form , lot # T030749 with expiration date on 16-MAR-2023 (route of administration was not reported) for prophylaxis. No adverse event was reported.
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No other AE; The caller said she administered an adult dose of VAQTA to an 18 month old patient today; This spontaneous report was received from a medical assisstant, referring to a 18-month-old patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.  On 09-DEC-2021, the reporter said that she administered an adult dose of hepatitis a vaccine, inactivated (VAQTA) to the 18-month-old patient as prophylaxis (product administered to patient of inappropriate age) (exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number t040581 has been verified to be a valid lot number for hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, expiration date reported and upon internal validation established as 28-MAR-2022). No adverse event was reported.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: Incorrect route of product administration
Clinical narrative: The patient is not experiencing any side effects.; administered V ARlV AX intramuscularly vs. subcutaneously; This spontaneous report has been received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not provided.  On 03-DEC-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot # T037643, expiration date 06-NOV-2022, 0.5 milliliter, indication: prophylaxis) with sterile diluent (strength, dose, batch/lot # and expiration date were not reported) intramuscularly versus (vs.) subcutaneously (Incorrect route of product administration). The patient was not experiencing any side effects.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: Confirmed with caller no other AE occurred; an expired dose of VAQTA was administered today; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 09-DEC-2021, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated(VAQTA) 1 dose, lot # t013205, expiration date: 03-DEC-2021 (dose number, exact dose and route of administration were not reported) for prophylaxis (expired product administered). No other adverse event (AE) occurred (no adverse event). The administered dose did not have any temperature excursions prior to administration.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event, Product preparation issue
Clinical narrative: No additional adverse events (AEs) or product compliant (PQC) were reported.; expired Merck Sterile Diluent used to reconstitute vaccine that was administered; expired Merck Sterile Diluent used to reconstitute vaccine that was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.    On 10-NOV-2021, expired sterile diluent (manufacturer unknown) (lot # S002625; expiration date: 09-NOV-2021) was used to reconstitute vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA) (PROQUAD) (lot # U006312; expiration date: 24-AUG-2022; strength, dose and route were not reported) that was administrated to patient for prophylaxis (product preparation issue and expired product administered). No additional adverse events (AEs) or product compliant (PQC) were reported (no adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA004629: US-009507513-2112USA004666: US-009507513-2112USA004424: US-009507513-2112USA004364: US-009507513-2112USA004666:
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; PEDVAX HIB was administered after the expiration date of 24-OCT-2021; This spontaneous report has been received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  On 10-DEC-2021, the patient was vaccinated with haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number KP24R was not valid for haemophilus B conjugate vaccine (meningococcal protein conjugate) and did not match any Company product, expiration date reported as 24-OCT-2021; strength, dose and route were not reported) after the expiration date for prophylaxis (expired product administered). The reporter suspected that other administrations might have occurred since the expiration date but could not confirm. It was reported that the haemophilus B conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) had no prior temperature excursions. No additional adverse event was reported.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Neuralgia, Pain
Clinical narrative: excruciating nerve pain that was shooting to her shoulders after receiving the PNEUMOV AX; This spontaneous report as received from a pharmacist refers to a 66-year-old female patient. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies included ciclopirox (PENLAC).     On 08-DEC-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T028093 was confirmed to be valid, expiration date 24-APR-2022, 0.5 milliliter, intramuscularly for prophylaxis.   On 10-DEC-2021 at 01:00 am, the patient experienced excruciating nerve pain that was shooting to her shoulders. She was given tramadol 1 every 6 hours as needed for pain as a treatment. The patient sought medical attention- she went to the doctor. The outcome of neuralgia was unknown.   The causality assessment between the event and the suspect vaccine was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Painful; Itchy; I still have it now from Aug have shingle shot/Suspected vaccination failure; I still have it now; 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. In August 2021, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced pain and pruritus. The patient was treated with lidocaine. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient said still had it now, from August. The patient had shingle shot, taking pills for it also Ladocaine to rub on it still had it so painful and itchy. The patient give up on it, praying for his healing. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available. The case had been linked with US2021AMR257685, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR257685:pharma case (same patient)
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pain in extremity, Vaccination failure
Clinical narrative: Had the shots, just got over shingles/ Suspected vaccination failure; Just got over shingles; Painful; Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and pain in arm. On an unknown date, the outcome of the vaccination failure, pain and pain in arm were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pain in arm to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided are as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received both Shingles shots 2 years ago and just got over a case of the shingles. The patient had zero side effects from the vaccine other than a sore arm. The patient stated that according to his/her doctor it was a light case but it was painful nonetheless. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Erythema, Fatigue, Headache, Pain
Clinical narrative: Shivering; Fever; Tiredness; Headache; Pain; Redness; Swelling; Arm is very itchy; This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th December 2021 09:00, the patient received the 1st dose of Shingrix. On 13th December 2021, immediately after receiving Shingrix, the patient experienced pain, erythema and swelling. On 14th December 2021, the patient experienced shivering, fever, fatigue and headache. In December 2021, the patient experienced itchy upper limbs. On an unknown date, the outcome of the pain, erythema, swelling and itchy upper limbs were unknown and the outcome of the shivering, fever, fatigue and headache were recovering/resolving.   It was unknown if the reporter considered the pain, erythema, swelling, shivering, fever, fatigue, headache and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and almost immediately experienced pain, redness and swelling. The patient also experienced shivering, fever, tiredness, headache side effects started the evening of the 14th December 2021. That was seems to be getting better. But his/her arm was very itchy. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus, Pyrexia, Swelling
Clinical narrative: Shivering; Fever; Tiredness; Headache; Pain; Redness; Swelling; Arm is very itchy; This case was reported by a consumer via (Shingrix GSK) interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th December 2021 09:00, the patient received the 1st dose of Shingrix. On 13th December 2021, immediately after receiving Shingrix, the patient experienced pain, erythema and swelling. On 14th December 2021, the patient experienced shivering, fever, fatigue and headache. In December 2021, the patient experienced itchy upper limbs. On an unknown date, the outcome of the pain, erythema, swelling and itchy upper limbs were unknown and the outcome of the shivering, fever, fatigue and headache were recovering/resolving.   It was unknown if the reporter considered the pain, erythema, swelling, shivering, fever, fatigue, headache and itchy upper limbs to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and almost immediately experienced pain, redness and swelling. The patient also experienced shivering, fever, tiredness, headache side effects started the evening of the 14th December 2021. That was seems to be getting better. But his/her arm was very itchy. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: vaccine was not properly reconstituted first; patient was given just the liquid; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that they had an extra lyophilized antigen powder vial and was missing the liquid adjuvant suspension vial. The reporter thought that they had a medial error. The patient was given just the liquid and that the vaccine was not properly reconstituted first, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The clinic was investigating to try to identify which patient this happened to and currently the patient information was unknown. The reporter agreed to follow up from GlaxoSmithKline.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, Nervous system injury
Clinical narrative: Bell's palsy; nervous system was attacked; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Lymphoma.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant) and NERVOUS SYSTEM INJURY (nervous system was attacked). At the time of the report, BELL'S PALSY (Bell's palsy) and NERVOUS SYSTEM INJURY (nervous system was attacked) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment: This spontaneous case concerns a 75-year-old, male patient with relevant medical history of Lymphoma, who experienced the expected AESI of Bell's palsy and the unexpected, non-serious event of nervous system injury following administration of the second dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. The patient was diagnosed with Bell's Palsy and reported that his nervous system was attacked. No further details were provided. The rechallenge was not applicable as no additional dosing will be given. The medical history of Lymphoma, which can mimick Bell's Palsy, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.; Sender's Comments: This spontaneous case concerns a 75-year-old, male patient with relevant medical history of Lymphoma, who experienced the expected AESI of Bell's palsy and the unexpected, non-serious event of nervous system injury following administration of the second dose of the Moderna mRNA-1273 vaccine. The start dates of the events were not provided. The patient was diagnosed with Bell's Palsy and reported that his nervous system was attacked. No further details were provided. The rechallenge was not applicable as no additional dosing will be given. The medical history of Lymphoma, which can mimick Bell's Palsy, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder
Clinical narrative: COVID TONGUE; This spontaneous report received from a patient 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced covid tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid tongue was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: DOSES WERE STORED IN A DORM STYLE REFRIGERATOR FOR AN UNKNOWN TIME AND WITH NO TEMPERATURE MONITORING AND ADMINISTERED TO PATIENTS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients. 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, start therapy date were not reported for prophylactic vaccination (dose no in series 1). The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced doses were stored in a dorm style refrigerator for an unknown time and with no temperature monitoring and administered to subjects, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the doses were stored in a dorm style refrigerator for an unknown time and with no temperature monitoring and administered to patients and incorrect product storage was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis
Clinical narrative: blood clot; pain in leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot) and PAIN IN EXTREMITY (pain in leg) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced THROMBOSIS (blood clot) (seriousness criteria death and medically significant) and PAIN IN EXTREMITY (pain in leg) (seriousness criterion death). The reported cause of death was Pain in leg. An autopsy was performed. The autopsy-determined cause of death was blood clot.            Concomitant medications were not reported. treatment medications were not reported.  Company comment: This case concerns a 62-year-old male patient with no medical history reported, who experienced the fatal events of thrombosis and in in extremity. The events occurred an unknown time after the second dose of mRNA-1273. Autopsy report states cause of death as thrombosis. This case report has been submitted by a consumer who knew the patient, though limited information regarding medical history, clinical presentation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 62-year-old male patient with no medical history reported, who experienced the fatal events of thrombosis and in in extremity. The events occurred an unknown time after the second dose of mRNA-1273. Autopsy report states cause of death as thrombosis. This case report has been submitted by a consumer who knew the patient, though limited information regarding medical history, clinical presentation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Pain in leg; Autopsy-determined Cause(s) of Death: Blood clot
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Nausea, Vomiting
Clinical narrative: passed out; nauseous; vomited; had a very intense headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out), NAUSEA (nauseous), VOMITING (vomited) and HEADACHE (had a very intense headache) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A, 027H21B and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out), NAUSEA (nauseous), VOMITING (vomited) and HEADACHE (had a very intense headache). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), NAUSEA (nauseous), VOMITING (vomited) and HEADACHE (had a very intense headache) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.  Company Comment: This case concerns a 49-year-old female patient with no medical history, who experienced the unexpected event of Loss of consciousness and the expected events of Nausea, Vomiting and Headache. The events occurred 15 hours after the second dose of mRNA-1273 Vaccine. The rechallenge is not applicable since no further dosing is expected. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-406048 (Patient Link).; Sender's Comments: This case concerns a 49-year-old female patient with no medical history, who experienced the unexpected event of Loss of consciousness and the expected events of Nausea, Vomiting and Headache. The events occurred 15 hours after the second dose of mRNA-1273 Vaccine. The rechallenge is not applicable since no further dosing is expected. At the time of the report the outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Seizure
Clinical narrative: unprovoked seizure; does not remember the incident at all; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (unprovoked seizure) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Penicillin allergy.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SEIZURE (unprovoked seizure) (seriousness criteria hospitalization and medically significant) and MEMORY IMPAIRMENT (does not remember the incident at all). At the time of the report, SEIZURE (unprovoked seizure) and MEMORY IMPAIRMENT (does not remember the incident at all) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.  Company Comment: This case concerns a 61-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI event of Seizure and the unexpected event of Memory impairment. The events occurred on an unknown date after the second dose of mRNA-1273 Vaccine. which resulted in hospitalization At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 61-year-old, female patient with no relevant medical history, who experienced the unexpected serious AESI event of Seizure and the unexpected event of Memory impairment. The events occurred on an unknown date after the second dose of mRNA-1273 Vaccine. which resulted in hospitalization At the time of the report the outcome of the events was unknown. The rechallenge is not applicable since no further dosing is expected. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced THROMBOSIS (blood clot) (seriousness criteria death and medically significant). The patient died in 2021. The reported cause of death was blood clot. An autopsy was performed.            No Concomitant informations were reported.  No Treatment informations were reported.  Company comment: This case concerns a 56-year-old female patient with no medical history reported, who experienced the fatal event of thrombosis. The event occurred an unknown time after the booster dose of mRNA-1273. Autopsy report states cause of death as thrombosis. This report has been submitted by a consumer who knew the patient, though limited information regarding medical history, clinical presentation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 56-year-old female patient with no medical history reported, who experienced the fatal event of thrombosis. The event occurred an unknown time after the booster dose of mRNA-1273. Autopsy report states cause of death as thrombosis. This report has been submitted by a consumer who knew the patient, though limited information regarding medical history, clinical presentation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: Blood clot
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: J&J COVID-19 vaccine and Moderna COVID-19 vaccine 4-6 weeks later developed symptoms of Guillain-Barré (GBS); This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (J&J COVID-19 vaccine and Moderna COVID-19 vaccine 4-6 weeks later developed symptoms of Guillain-Barré (GBS)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for an unknown indication.    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 and dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (J&J COVID-19 vaccine and Moderna COVID-19 vaccine 4-6 weeks later developed symptoms of Guillain-Barré (GBS)) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (J&J COVID-19 vaccine and Moderna COVID-19 vaccine 4-6 weeks later developed symptoms of Guillain-Barré (GBS)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter. Consumer stated they went on VAERS Report and noticed that patient who have received J and J COVID-19 vaccine and Moderna COVID-19 vaccine 4-6 weeks later developed symptoms of Guillain-Barre.  Company comment: This case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, serious (medically significant) event of Guillain-Barre syndrome. The event occurred an unknown time after a dose of mRNA-1273. Concomitant administration of JANSSEN COVID-19 vaccine is a confounder. Information regarding medical history, clinical presentation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, serious (medically significant) event of Guillain-Barre syndrome. The event occurred an unknown time after a dose of mRNA-1273. Concomitant administration of JANSSEN COVID-19 vaccine is a confounder. Information regarding medical history, clinical presentation, diagnostic tests and treatment provided has not been disclosed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: mild case of Bell's palsy (diagnosed) post 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (mild case of Bell's palsy (diagnosed) post 2nd dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (mild case of Bell's palsy (diagnosed) post 2nd dose). At the time of the report, BELL'S PALSY (mild case of Bell's palsy (diagnosed) post 2nd dose) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.  Company comment: This Spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the expected, non-serious and AESI of Bell's palsy. The events occurred after receiving the first dose of mRNA-1273 vaccine. Patient experienced a mild case of Bell's palsy which was diagnosed at the hospital emergency room approximately two months after receiving the second dose of mRNA-1273 vaccine. The rechallenge is not applicable, as no additional dose information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the expected, non-serious and AESI of Bell's palsy. The events occurred after receiving the first dose of mRNA-1273 vaccine. Patient experienced a mild case of Bell's palsy which was diagnosed at the hospital emergency room approximately two months after receiving the second dose of mRNA-1273 vaccine. The rechallenge is not applicable, as no additional dose information was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Their friend died from getting the shot; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Their friend died from getting the shot) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: This Spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected, serious (fatal) event of death. Cause or date of death was not reported. It was reported that the patient died after vaccination with an unknown dose number of mRNA-1273 vaccine. The rechallenge is not applicable, considering the outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected, serious (fatal) event of death. Cause or date of death was not reported. It was reported that the patient died after vaccination with an unknown dose number of mRNA-1273 vaccine. The rechallenge is not applicable, considering the outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm is sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION SITE PAIN (Injection arm is sore). At the time of the report, VACCINATION SITE PAIN (Injection arm is sore) outcome was unknown.            No concomitant medications were reported. No treatment information were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 range (Inconclusive) Patients antibody numbers were in the 800-900 range.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Moderna vaccine (037C21A) was delivered in on 24 May2021 and immediately placed the vaccine into refrigerated storage. They indicated that the doctors did not know a 30-day expiration date applied to vaccines kept in the refrigerator and administered this vaccine to patients after this 30-day mark.  Patient did not report any adverse events or symptoms.  Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-415889 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Expired product administered
Clinical narrative: expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired doses administered) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired doses administered). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired doses administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 800-900 (Inconclusive) the patients antibody numbers were in the 800-900 range..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The doctors did not knowa 30-day expiration date applied to vaccines kept in the refrigerator. These vaccine was administered  to patient after 30-day mark.   It was reported that the patient did not report any adverse events or symptoms.   No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-415889 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Eye pain, Headache, Neck pain
Clinical narrative: The pain moved up to the neck; Pain moved up around ear and into ear/pain in ear felt like an ice pick; Pain in the eye; A lot of pain in arm; Pain moved up to the shoulder; Pain in temple; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (The pain moved up to the neck), EAR PAIN (Pain moved up around ear and into ear/pain in ear felt like an ice pick), EYE PAIN (Pain in the eye), PAIN IN EXTREMITY (A lot of pain in arm) and ARTHRALGIA (Pain moved up to the shoulder) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (1st dose) on 16-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Hypothyroidism (Low thyroid that makes her feel tired and weak usually), Tiredness, Weakness and Balance disorder (Balance problem).    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced NECK PAIN (The pain moved up to the neck), EAR PAIN (Pain moved up around ear and into ear/pain in ear felt like an ice pick), EYE PAIN (Pain in the eye), PAIN IN EXTREMITY (A lot of pain in arm), ARTHRALGIA (Pain moved up to the shoulder) and HEADACHE (Pain in temple). In December 2021, PAIN IN EXTREMITY (A lot of pain in arm) had resolved. At the time of the report, NECK PAIN (The pain moved up to the neck), EAR PAIN (Pain moved up around ear and into ear/pain in ear felt like an ice pick), EYE PAIN (Pain in the eye) and HEADACHE (Pain in temple) had not resolved and ARTHRALGIA (Pain moved up to the shoulder) outcome was unknown.            Concomitant medications included pig thyroid. No treatment medications were taken by the patient.  It happened 1-2 days after the shot that slowly progressed. Patient was  still having pain in eye, ear and temple and was 11 days at the time of reporting.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The pain moved up to the neck; Pain moved up around ear and into ear/pain in ear felt like an ice pick; Pain in the eye; A lot of pain in arm; Pain moved up to the shoulder; Pain in temple; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (The pain moved up to the neck), EAR PAIN (Pain moved up around ear and into ear/pain in ear felt like an ice pick), EYE PAIN (Pain in the eye), PAIN IN EXTREMITY (A lot of pain in arm) and ARTHRALGIA (Pain moved up to the shoulder) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (1st dose) on 16-Mar-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Hypothyroidism (Low thyroid that makes her feel tired and weak usually), Tiredness, Weakness and Balance disorder (Balance problem).    On 04-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced NECK PAIN (The pain moved up to the neck), EAR PAIN (Pain moved up around ear and into ear/pain in ear felt like an ice pick), EYE PAIN (Pain in the eye), PAIN IN EXTREMITY (A lot of pain in arm), ARTHRALGIA (Pain moved up to the shoulder) and HEADACHE (Pain in temple). In December 2021, PAIN IN EXTREMITY (A lot of pain in arm) had resolved. At the time of the report, NECK PAIN (The pain moved up to the neck), EAR PAIN (Pain moved up around ear and into ear/pain in ear felt like an ice pick), EYE PAIN (Pain in the eye) and HEADACHE (Pain in temple) had not resolved and ARTHRALGIA (Pain moved up to the shoulder) outcome was unknown.            Concomitant medications included pig thyroid. No treatment medications were taken by the patient.  It happened 1-2 days after the shot that slowly progressed. Patient was  still having pain in eye, ear and temple and was 11 days at the time of reporting.