chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myasthenia gravis, Ophthalmological examination
Clinical narrative: On 2-23-2021  was leaving a doctors office. I was backing out of my parking space and went blind in my left eye for 45 seconds to a minute. When it cleard up I made an appointment with my personal doctor.He had set up brain scans and other test at the hospital on 3-2-2021. The night before I started seeeing double and got dizzy. I went to the emergency room. I took a brain scan and blood test. Nothing showed up. The next day I was back at the hospital doing MRI, Cat Scan, and ateries checking everything nothing showed up. Off and on for the next year I had double vision for short periods of time and it would clear up. May 2 or 3 of 2022 I was driving on highway and everything went double vision.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness unilateral, Blood test abnormal, Brain scan normal, Computerised tomogram normal, Diplopia
Clinical narrative: On 2-23-2021  was leaving a doctors office. I was backing out of my parking space and went blind in my left eye for 45 seconds to a minute. When it cleard up I made an appointment with my personal doctor.He had set up brain scans and other test at the hospital on 3-2-2021. The night before I started seeeing double and got dizzy. I went to the emergency room. I took a brain scan and blood test. Nothing showed up. The next day I was back at the hospital doing MRI, Cat Scan, and ateries checking everything nothing showed up. Off and on for the next year I had double vision for short periods of time and it would clear up. May 2 or 3 of 2022 I was driving on highway and everything went double vision.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Eye patch application, Laboratory test normal, Magnetic resonance imaging normal, Myasthenia gravis
Clinical narrative: On 2-23-2021  was leaving a doctors office. I was backing out of my parking space and went blind in my left eye for 45 seconds to a minute. When it cleard up I made an appointment with my personal doctor.He had set up brain scans and other test at the hospital on 3-2-2021. The night before I started seeeing double and got dizzy. I went to the emergency room. I took a brain scan and blood test. Nothing showed up. The next day I was back at the hospital doing MRI, Cat Scan, and ateries checking everything nothing showed up. Off and on for the next year I had double vision for short periods of time and it would clear up. May 2 or 3 of 2022 I was driving on highway and everything went double vision.
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 35 year old received Fluzone HD which is intended for 65+ age group - no side effects
Age: 35.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 35 year old received Fluzone HD which is intended for 65+ age group - no side effects
Age: 13.0
Sex: F
Vaccine: FLUC4, FLUC3
Symptoms: Syncope
Clinical narrative: Syncope; This spontaneous case was retrieved on 21-Dec-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2523408-1), reported by other healthcare professional, and concerned a 13-year-old, female patient.   The patient's medical history and concomitant medications were not reported. The patient had no known drug allergy.  On 30-Jan-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 'one'; route of administration: intramuscular; anatomical location: left arm; indication: not reported). The batch number reported was 348382.  On the same date, after receiving Flucelvax Quadrivalent, the patient experienced syncope. The patient had not eaten since 12 pm so blood sugar plus high ambient temperature could've been factors. The patient was seated for 30 minutes (mins) and was allowed to recover. The patient was offered with drinks and snacks. It was suggested emergency services should be called, but guardian refused. The patient felt better in a couple of minutes and was able to leave and walk on her own.  On 30-Jan-2022, the patient recovered from the event.  The reporter did not provide a causality assessment.   The event of syncope was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 13-year-old, female patient was vaccinated with Flucelvax Quadrivalent. On the same day after vaccination, the patient experienced syncope. The patient's medical history and concomitant medications were not reported. The patient had no known drug allergy. Causal role of the suspect vaccine is assessed as possibly related for the event syncope, with the currently available information and plausible temporal relationship.; Sender's Comments: A 13-year-old, female patient was vaccinated with Flucelvax Quadrivalent. On the same day after vaccination, the patient experienced syncope. The patient's medical history and concomitant medications were not reported. The patient had no known drug allergy. Causal role of the suspect vaccine is assessed as possibly related for the event syncope, with the currently available information and plausible temporal relationship.
Age: 12.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: no known adverse event
Age: 12.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event
Clinical narrative: no known adverse event
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus
Clinical narrative: Covid diagnosis: Christmas Day 25Dec2021; Covid diagnosis; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid diagnosis) and VACCINATION FAILURE (Covid diagnosis: Christmas Day 25Dec2021) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Idiopathic thrombocytopenic purpura (child acute ITP when they were like 27 months old but is on no medication). Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid diagnosis). On an unknown date, the patient experienced VACCINATION FAILURE (Covid diagnosis: Christmas Day 25Dec2021). At the time of the report, COVID-19 (Covid diagnosis) and VACCINATION FAILURE (Covid diagnosis: Christmas Day 25Dec2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.  COMPANY COMMENT: This spontaneous case concerns a 36 year old female patient with no relevant medical history reported, who experienced the unexpected non-serious event of COVID-19. Vaccination failure was also reported. The event occurred 317 days after the second dose of mRNA-1273 and 345 days after the first dose of mRNA-1273. The clinical course, concomitant medication and treatment information were not provided. The events might be explained by COVID-19 pandemic outbreak. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-689944 (Patient Link).; Sender's Comments: COMPANY COMMENT: This spontaneous case concerns a 36 year old female patient with no relevant medical history reported, who experienced the unexpected non-serious event of COVID-19. Vaccination failure was also reported. The event occurred 317 days after the second dose of mRNA-1273 and 345 days after the first dose of mRNA-1273. The clinical course, concomitant medication and treatment information were not provided. The events might be explained by COVID-19 pandemic outbreak. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Covid diagnosis: Christmas Day 25Dec2021; Covid diagnosis; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid diagnosis) and VACCINATION FAILURE (Covid diagnosis: Christmas Day 25Dec2021) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Idiopathic thrombocytopenic purpura (child acute ITP when they were like 27 months old but is on no medication). Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid diagnosis). On an unknown date, the patient experienced VACCINATION FAILURE (Covid diagnosis: Christmas Day 25Dec2021). At the time of the report, COVID-19 (Covid diagnosis) and VACCINATION FAILURE (Covid diagnosis: Christmas Day 25Dec2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.  COMPANY COMMENT: This spontaneous case concerns a 36 year old female patient with no relevant medical history reported, who experienced the unexpected non-serious event of COVID-19. Vaccination failure was also reported. The event occurred 317 days after the second dose of mRNA-1273 and 345 days after the first dose of mRNA-1273. The clinical course, concomitant medication and treatment information were not provided. The events might be explained by COVID-19 pandemic outbreak. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-689944 (Patient Link).; Sender's Comments: COMPANY COMMENT: This spontaneous case concerns a 36 year old female patient with no relevant medical history reported, who experienced the unexpected non-serious event of COVID-19. Vaccination failure was also reported. The event occurred 317 days after the second dose of mRNA-1273 and 345 days after the first dose of mRNA-1273. The clinical course, concomitant medication and treatment information were not provided. The events might be explained by COVID-19 pandemic outbreak. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; Nurse called and reported that an expired dose of VARIVAX was administered to a 23 year old patient yesterday, 12/15/22. Patient has no reported side effects of adverse events. Nurse informed that the dose administered is supported per the post expir; This spontaneous report has been received from a nurse referring to a 23-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, and allergies were not reported. Concomitant therapies included sterile diluent(STERILE DILUENT).     On 15-DEC-2022, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot #T041505 has been verified to be a valid, expiration date not reported, but upon internal validation established as 09-DEC-2022) for prophylaxis (dose, vaccination scheme, frequency, route of administration, anatomical site of injection, lot number, and expiration date were not reported) (expired product administered). No additional adverse event was reported.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix Administered; A Health Care Professional called to ask for information regarding the administration of an expired dose of Havrix to a 14-month old patient. The reporter asked for information about the stability of the vaccine after the expiration date.  ~~~~~~~Consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Death, Thrombosis
Clinical narrative: DIED; BLOOD CLOT; This spontaneous report received from a parent via social media via a company representative concerned a male of unspecified age, race and ethnicity. 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: unknown, expiry date: unknown) dose not reported, 01 total administered on an unspecified date for covid-19 prophylaxis. 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 died from blood clot. It was unknown if an autopsy was performed. Reporter stated, "my son had blood clot and died also." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of blood clot on an unspecified date. This report was serious (Death).; Sender's Comments: V0: 20221246512-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221246512-Blood clot. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: BLOOD CLOT
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: No adverse event; Patient had original Moderna Covid 19 vaccination on 20-Sep-2021 (O4SC21A), want to inquire if patient need a second dose or just a booster/was told the 2nd dose of Moderna Covid vaccine is no longer available; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient had original Moderna Covid 19 vaccination on 20-Sep-2021 (O4SC21A), want to inquire if patient need a second dose or just a booster/was told the 2nd dose of Moderna Covid vaccine is no longer available) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient had original Moderna Covid 19 vaccination on 20-Sep-2021 (O4SC21A), want to inquire if patient need a second dose or just a booster/was told the 2nd dose of Moderna Covid vaccine is no longer available). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient had original Moderna Covid 19 vaccination on 20-Sep-2021 (O4SC21A), want to inquire if patient need a second dose or just a booster/was told the 2nd dose of Moderna Covid vaccine is no longer available) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient had original Moderna Covid 19 vaccination on 20-Sep-2021 (O4SC21A), want to inquire if patient need a second dose or just a booster/was told the 2nd dose of Moderna Covid vaccine is no longer available).    No concomitant medication information was provided. No treatment medication were provided.
Sex: U
Vaccine: COVID19
Symptoms: Atrial flutter, Cerebrovascular accident
Clinical narrative: 3 mini Strockes; Atrial flutter; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (3 mini Strockes) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In October 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2022, the patient experienced CEREBROVASCULAR ACCIDENT (3 mini Strockes) (seriousness criterion medically significant) and ATRIAL FLUTTER (Atrial flutter). At the time of the report, CEREBROVASCULAR ACCIDENT (3 mini Strockes) and ATRIAL FLUTTER (Atrial flutter) outcome was unknown.            Concomitant medication not reported. Treatment medication not reported.  Company Comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious, adverse event of special interest of Cerebrovascular Accident and the unexpected, non-serious, adverse event of special interest Atrial Flutter. The events occurred approximately 5 months after receiving a dose of mRNA-1273 Original Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The reported outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Original Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious, adverse event of special interest of Cerebrovascular Accident and the unexpected, non-serious, adverse event of special interest Atrial Flutter. The events occurred approximately 5 months after receiving a dose of mRNA-1273 Original Vaccine. No further information on risk factors, co morbidities, clinical course and management of the events was available in the report. The reported outcome of the events was unknown. The benefit-risk relationship of mRNA-1273 Original Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No relevant concomitant medications were reported. Vaccine was moved from freezer to refrigerator on 12/02/22. Of the ten vials in question 43 injections were given and 7 doses were wasted. No treatment medication reported.  This case contains information for the 7th of 43 adult patients described by the reporter.; Sender's Comments:  master case
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine administered after after 4 temperature excursions; Vaccine administered after after 4 temperature excursions; No aderse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions) and NO ADVERSE EVENT (No aderse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No aderse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after after 4 temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after after 4 temperature excursions).    No concomitant medications were reported.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that vaccine was moved from freezer to refrigerator on 12/2/22 of the ten vials in question 43 injections were given and 7 doses were wasted. Vaccine administered after after 4 temperature excursions.  No treatment medication was provided.  This case contains information for the 34th of 43 adult patients described by the reporter.   This case was linked to (E2B Linked Report).; Sender's Comments:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2022 at 3:05 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Nov-2022 at 3:05 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant drug information was provided.  It was reported that 51 doses from Lot AS7140C, and 60 doses from Lot AS7148B were administered. No treatment drug information was provided.   This case was linked (Patient Link).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    51 doses was received to several patient from Lot AS7140C. Concomitant medications were not reported.  No treatment information was provided
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medication was not provided. It was unknown whether patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medication information was not provided by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medications were not reported.  It was reported that 51 doses from Lot AS7140C and 60 doses from Lot AS7148B were administered. No treatment information was provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medications were not reported.  It was reported that 51 doses from Lot AS7140C and 60 doses from Lot AS7148B were administered. No treatment information was provided.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: got the flu shot on wednesday, got the flu on friday; Initial information received on 21-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves an adult patient of unknown gender who got the flu shot on wednesday, got the flu on friday after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect  INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, strength, formulation, route was unknown) in unknown administration site for prophylactic vaccination(Immunisation). Information regarding batch number details has been requested.  On an unknown date the patient had a non-serious event of got the flu shot on wednesday, got the flu on friday (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available."  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu shot on wednesday, got the flu on friday).  Outcome was Unknown for the event got the flu shot on wednesday, got the flu on Friday.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Hypoaesthesia, Immediate post-injection reaction, Pyrexia
Clinical narrative: Slept 24 hours after shot, headache, fever for 5 days.  Huge wave ran across body directly after administration.   Numbness in fingers ever since.  Loss of touch/feel in finger tips ever since.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: Slept 24 hours after shot, headache, fever for 5 days.  Huge wave ran across body directly after administration.   Numbness in fingers ever since.  Loss of touch/feel in finger tips ever since.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Electrocardiogram, Gait disturbance, Hyperhidrosis, Impaired work ability
Clinical narrative: Started with shooting pain down my legs, followed by swelling and bulging veins. I haven?t been able to walk very well or up and down stairs I need assistance to get up from sitting or working on the floor.  I get shortness of breath quickly and sweating I am now unable to work.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pain in extremity, Scan, Swelling
Clinical narrative: Started with shooting pain down my legs, followed by swelling and bulging veins. I haven?t been able to walk very well or up and down stairs I need assistance to get up from sitting or working on the floor.  I get shortness of breath quickly and sweating I am now unable to work.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vein disorder
Clinical narrative: Started with shooting pain down my legs, followed by swelling and bulging veins. I haven?t been able to walk very well or up and down stairs I need assistance to get up from sitting or working on the floor.  I get shortness of breath quickly and sweating I am now unable to work.
Age: 62.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Abdominal distension, Angiogram pulmonary, Brain natriuretic peptide, Chest X-ray, Differential white blood cell count
Clinical narrative: Shortness of Breath, winded after walking short distances or in cold weather, fatigue, high blood pressure, gray skin color after being outside, bloating, weight gain and acid reflux discomfort.
Age: 62.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Discomfort, Dyspnoea, Dyspnoea exertional, Electrocardiogram, Fatigue
Clinical narrative: Shortness of Breath, winded after walking short distances or in cold weather, fatigue, high blood pressure, gray skin color after being outside, bloating, weight gain and acid reflux discomfort.
Age: 62.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Fibrin D dimer, Full blood count, Gastrooesophageal reflux disease, Hypertension, Metabolic function test
Clinical narrative: Shortness of Breath, winded after walking short distances or in cold weather, fatigue, high blood pressure, gray skin color after being outside, bloating, weight gain and acid reflux discomfort.
Age: 62.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: SARS-CoV-2 test negative, Scan with contrast, Skin discolouration, Troponin I, Weight increased
Clinical narrative: Shortness of Breath, winded after walking short distances or in cold weather, fatigue, high blood pressure, gray skin color after being outside, bloating, weight gain and acid reflux discomfort.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Bivalent doses administered after the BUD to patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Bivalent doses administered after the BUD to; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to).    No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 58-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 13-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    Patient ID was reported. Concomitant medications details were not reported by the reporter. It was reported that 51 doses received to several patient from Lot AS7140C. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment details were not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Bivalent doses administered after the BUD to patients 12 and up; Bivalent doses administered after the BUD to patients 12 and up; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Bivalent doses administered after the BUD to patients 12 and up), EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent doses administered after the BUD to patients 12 and up), EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Bivalent doses administered after the BUD to patients 12 and up), EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Bivalent doses administered after the BUD to patients 12 and up) and EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up).    No relevant concomitant medications were reported. No treatment medication reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.).    No relevant concomitant medications were reported.  No treatment information was provided.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Bivalent doses administered after the BUD to patients 12 and up.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 12-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up.).    No relevant concomitant medications were reported.  No treatment information was provided.