chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.67
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022); No adverse event; 2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)), PRODUCT STORAGE ERROR (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)), PRODUCT STORAGE ERROR (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)) and PRODUCT STORAGE ERROR (2SEP2022 (lot number AS1414B, expiration date unknown, thaw date 22AUG2022)).    No concomitant drug were reported.   It was reported that 7 Patients have received 8 doses of the Moderna COVID-19 vaccine by intramuscular injection after it had been stored more than 30 days past the initial thaw date. All patients received primary series doses of the 6m-5y presentation of the Moderna COVID-19 vaccine(lot number AS1414B, expiration date unknown). All patients have not reported any symptoms. No patients have received any additional doses, medications or treatments to the knowledge of the vaccination provider. Vial size was reported as 2.5mL.   On 22-JUL-2022, the vial was initially stored in the refrigerator.   Thaw date was reported as 22-Aug-2022.  The vial was not underwent any temperature excursions.   No treatment drug were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose) 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 WRONG PRODUCT ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose).    No concomitant medications were reported. It was reported that, the vaccine administrator inadvertently grabbed the underage Moderna 6 months to 5 years age vaccine and administered to the adult patient. It was reported that the CDC had recommended to immediately repeat that dose with the correct bivalent vaccine or discuss with the patient and wait 2 months for the bivalent.  This case contains information for the 4th of 5 Adult patient described by the reporter. No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-650478, US-MODERNATX, INC.-MOD-2022-650481, US-MODERNATX, INC.-MOD-2022-650482, US-MODERNATX, INC.-MOD-2022-650485 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650478: US-MODERNATX, INC.-MOD-2022-650481: US-MODERNATX, INC.-MOD-2022-650482: US-MODERNATX, INC.-MOD-2022-650485:
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Inadvertently grabbed the underage Moderna 6 months to 5 years and administered 0.5 ml of that to 5 adults instead of giving the bivalent to adults; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Inadvertently grabbed the underage Moderna 6 months to 5 years and administered 0.5 ml of that to 5 adults instead of giving the bivalent to adults) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Inadvertently grabbed the underage Moderna 6 months to 5 years and administered 0.5 ml of that to 5 adults instead of giving the bivalent to adults). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Inadvertently grabbed the underage Moderna 6 months to 5 years and administered 0.5 ml of that to 5 adults instead of giving the bivalent to adults) 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 WRONG PRODUCT ADMINISTERED (Inadvertently grabbed the underage Moderna 6 months to 5 years and administered 0.5 ml of that to 5 adults instead of giving the bivalent to adults).    No concomitant drug was reported. No treatment drug was reported. This case contains information for the 5th of 5 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-650483, US-MODERNATX, INC.-MOD-2022-650478, US-MODERNATX, INC.-MOD-2022-650481, US-MODERNATX, INC.-MOD-2022-650482 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650483:patient 4 US-MODERNATX, INC.-MOD-2022-650478:patient 1 US-MODERNATX, INC.-MOD-2022-650481:patient 2 US-MODERNATX, INC.-MOD-2022-650482:patient 3
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 prophylaxis.     It was unknown if patient had allergies to medication, foods and other products.  It was unknow if patient had ever been diagnosed with and or tested positive with COVID-19. Acute illness at the time of vaccination and up to one month before was unknown.     On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).    No concomitant medications were reported. Anatomical location of administration was reported as left. Expired Moderna vaccine had been given to 21 patients. The reporter explained that the vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergone any temperature excursion. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received contains updated reporter details
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown if patient had any allergies. It was unknown if patient ever diagnosed for COVID-19. It was unknown if patient had any acute illness or chronic long lasting condition.     On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    No concomitant product reported by reporter.  Expired Moderna vaccine had been given to 21 patients. The reporter explained that the vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022.  The vial did not undergone temperature excursion.  No treatment medication reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up information included fax number.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.  No Medical History information was reported.    On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.  For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). No concomitant medications were reported. It was unknown if patient had allergies to medication, foods and other products.  It was unknown if patient had ever been diagnosed with and or tested positive with COVID-19. Acute illness at the time of vaccination and up to one month before was unknown. Expired Moderna vaccine had been given to 21 patients. The reporter explained that the vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergone any temperature excursion. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received contains reporter address updated.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).    No concomitant medications were reported. It was unknown if patient had allergies to medication, foods and other products.  It was unknow if patient had ever been diagnosed with and or tested positive with COVID-19. Acute illness at the time of vaccination and up to one month before was unknown. Expired Moderna vaccine had been given to 21 patients. The reporter explained that the vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergone any temperature excursion. No treatment medications were reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received contains reporter address updated.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: expired vial was initially stored in the refrigerator on 20-Sep-2022; No adverse event; Expired vaccine was administered after the manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown that patient had ever been diagnosed with nor tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination up to one month before. It was unknown if patient had any chronic or long standing health conditions.     On 20-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry) and PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022).    No concomitant medication were reported.  It was reported that patient received 0.5 dose of vaccine during PM time.  It was reported that HCP gave Moderna Covid 19 vaccines and it was discovered after they had given 21 doses that it was expired recently from monovalent Individual vials of Vial size 5.5 ml. The vial had not undergone any temperature excursions.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-648572 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Follow up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648572:Master case
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     The information of allergies to medication, food and other products were unknown.     On 20-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant product use was not provided by the reporter. The information was unknown whether the patient had ever been diagnosed with/tested positive with COVID-19. The information of acute illness at the time of vaccination and up to one month before was unknown. Expired Moderna vaccine was given to the patient. The vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergo temperature excursion. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-648572 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received with updated reporter's address; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648572:Master case
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: expired vial was initially stored in the refrigerator on 20-Sep-2022; No adverse event; Expired vaccine was administered after the manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry) and PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022).    No concomitant medication were reported.  It was unknown that patient had ever been diagnosed with nor tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination up to one month before. It was unknown if patient had any chronic or long standing health conditions.  It was reported that patient received 0.5 dose of vaccine during PM time.  It was reported that HCP gave Moderna Covid 19 vaccines and it was discovered after they had given 21 doses that it was expired recently from monovalent Individual vials of Vial size 5.5 ml. The vial had not undergone any temperature excursions.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Follow up received contains no new information.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 56-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported. Anatomical location of administration was reported as left. It was unknown if patient had allergies to medication, foods and other products.  It was unknow if patient had ever been diagnosed with and or tested positive with COVID-19. Acute illness at the time of vaccination and up to one month before was unknown. Expired Moderna vaccine had been given to 21 patients. The reporter explained that the vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergone any temperature excursion. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received contains updated reporter details
Age: 41.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: given 21 doses that it was expired recently, had just taken it out of the freezer; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer).    It was unknown if patient had any allergies to medications, food and other products. It was unknown if patient was ever been diagnosed or tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination or a month before vaccination. Not known if patient had any chronic or long standing health conditions  No concomitant medication were reported.  Patient received Monovalent vaccine. Individual vials of size 5.5 ml. The vial was initially stored in the refrigerator on 20Sep2022. The vial did not undergo any temperature excursions  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received contains reporter address updated.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 6 year old patient received dose from 6m-5y vial; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (6 year old patient received dose from 6m-5y vial) and NO ADVERSE EVENT (No adverse event) in a 6-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Aug-2022, the patient experienced WRONG PRODUCT ADMINISTERED (6 year old patient received dose from 6m-5y vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (6 year old patient received dose from 6m-5y vial) 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 WRONG PRODUCT ADMINISTERED (6 year old patient received dose from 6m-5y vial).    Concomitant medication details were not reported by the reporter.  The physician stated that the connection was not good, so requested to be called back on cell phone. The physician stated physician was so confused because physician thought only Pfizer was approved for aged 6 and older. Physician stated they were not giving Moderna for kids over 6 years and did not know any providers in area who were giving Moderna for that age group.  Treatment details was not reported by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash, Vaccination site lymphadenopathy, Vaccination site rash
Clinical narrative: burning; itching; rash around her neck; swelling of the lymph nodes in the same site of the injection; rash reaction in her arm/covid arm; This spontaneous case was reported by a patient and describes the occurrence of BURNING SENSATION (burning), PRURITUS (itching), RASH (rash around her neck), VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in the same site of the injection) and VACCINATION SITE RASH (rash reaction in her arm/covid arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (burning), PRURITUS (itching), RASH (rash around her neck), VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in the same site of the injection) and VACCINATION SITE RASH (rash reaction in her arm/covid arm). At the time of the report, BURNING SENSATION (burning), PRURITUS (itching), RASH (rash around her neck), VACCINATION SITE LYMPHADENOPATHY (swelling of the lymph nodes in the same site of the injection) and VACCINATION SITE RASH (rash reaction in her arm/covid arm) outcome was unknown.            No concomitant medications was reported. Patient asked if itching was an allergy. Patient did not provide any other information on the event. No treatment medications was reported.   This case was linked to MOD-2022-650771 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm with first 3 injections; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm with first 3 injections) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm with first 3 injections). At the time of the report, PAIN IN EXTREMITY (Sore arm with first 3 injections) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.   This case was linked to MOD-2022-650769 (Patient Link).   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: flu-like reaction; temperature; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like reaction) and PYREXIA (temperature) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 09-Sep-2022, the patient experienced INFLUENZA LIKE ILLNESS (flu-like reaction) and PYREXIA (temperature). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In September 2022, INFLUENZA LIKE ILLNESS (flu-like reaction) and PYREXIA (temperature) had resolved.      Concomitant drugs were not reported. It was reported that patient received doses of the Moderna COVID-19 vaccine intramuscularly as Dose 1 on 29-Feb-2021 (lot number unknown, expiration date unknown), Dose 2 on 29-Mar-2021 (lot number unknown, expiration date unknown) and Dose 3 on 09-Apr-2022 (lot number unknown, expiration date unknown) for COVID-19 prophylaxis. It was reported that the evening after each doses patient had flu like reaction with temperature which went away after 48 to 72 Hours.   This case was linked to MOD-2022-650905 (Patient Link).
Sex: F
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins); This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003725, MCM-003726, MCM-003729, MCM-003734, MCM-003735, MCM-003737, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003761, MCM-003763, MCM-003766, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site pain; On 25-SEP-2022, a serious initial non-interventional study safety report was received from a consumer via study and was received by Novavax on 25-SEP-2022.  An individual of an unspecified race,age and sex was vaccinated with intramuscular Covid-19 Vaccine (Recombinant and Adjuvanted) 10 ug/mL suspect Covid-19 vaccine unspecified dose on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the individual experienced injection site pain (PT: Injection site pain) (Serious: Hospitalization).  At the time of reporting, the event outcome of Injection site pain was unknown.  The reporter assessed the causality between vaccine and reported events: Injection site pain as Not Reported.  Lot number was not provided in the report.; Sender's Comments: This individual of an unspecified age and sex experienced: Injection site pain after vaccination with Covid-19 Vaccine (Recombinant, Adjuvanted) 10 ug/mL. The event Injection site pain was reported as serious. Considering the current knowledge of the vaccine, the causal relationship between Covid-19 Vaccine (Recombinant and Adjuvanted) and Injection site pain was assessed as related.
Sex: F
Vaccine: COVID19-2
Symptoms: Gingival disorder, Incorrect dose administered, Underdose
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 Immunization, reaction(s): "Site of vaccine has no pain, unlike previos 3 Pfizer"; Bnt162b2 (Dose 2, single), for Covid-19 Immunization, reaction(s): "vaccine has no pain, unlike previos 3 Pfizer"; Bnt162b2 (Dose number unknown (booster), single), for Covid-19 Immunization, reaction(s): "vaccine has no pain, unlike previos 3 Pfizer"; Moderna vaccine (Dose number unknown (booster), single), for Covid-19 Immunization. The following information was reported: UNDERDOSE (non-serious) with onset 21Sep2022, outcome "unknown", described as "It leaked, 2 drops on my hand, one or so on the arm of the chair, and some on the floor"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 21Sep2022, outcome "unknown", described as "Patient was given the Pfizer bivalent booster"; GINGIVAL DISORDER (non-serious), outcome "unknown", described as "light raised bump". Additional information: Patient was given the Pfizer bivalent booster yesterday (as reported) at a (Pharmacy name). The vaccine was delivered at an angle, as she was asked to be seated and the pharmacist was not. It leaked, 2 drops on her hand, one or so on the arm of the chair, and some on the floor (didn't see, just saw her wipe it, maybe a drop or two). Effective dose or not. she weigh about 125 pounds, when she was 68 years old. Site of vaccine had no pain, unlike previous 3 Pfizer and one Moderna vaccine or booster. Patient stated, she had a light raised bump, but no soreness. The person at pharmacy said she got enough. She had a reaction every single time before, but not this time. Patient asking if the fact she had no side effects after the vaccine means the vaccine was not working. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : PFIZER INC-202201182347 similar report from same reporter; PFIZER INC-202201182346 similar report from same reporter;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive on Saturday; tested positive on Saturday; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Sep2022, outcome "unknown" and all described as "tested positive on Saturday". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Sep2022) Negative, notes: He tested negative for COVID-19 on Thursday; (16Sep2022) Negative, notes: He tested negative for COVID-19 on Friday; (17Sep2022) Positive, notes: Eventually tested positive on Saturday. The patient got the updated Pfizer Biontech COVID-19 booster on Thursday 08Sep2022. The following Wednesday 14Sep2022 he began having some COVID-19 symptoms, he just noticed a slight cough like when you have allergy by Thursday morning he referred that he knew something was happening and he was getting sick. He tested negative for COVID-19 on Thursday and Friday but eventually tested positive on Saturday. The patient wanted to know since the vaccine had not been in his body for at least 15 days and he had COVID-19 now, was it still going to create antibodies and help him or not. The patient wanted to know whether he should consider getting another updated vaccine before six months or he should assume that the infection would create the antibodies as the vaccine would.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Site of vaccine has no pain, unlike previous 3 Pfizer; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction: "Site of vaccine has no pain, unlike previous 3 Pfizer". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Site of vaccine has no pain, unlike previous 3 Pfizer".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201182250 same patient/product, different dose/events;US-PFIZER INC-202201182347 same patient/product/event, different dose;US-PFIZER INC-202201182345 same patient/product/event, different dose;
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Nasopharyngitis, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Soreness at injection site.; Cold; Allergy symptoms; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 11:15 as dose 4 (booster), single (Lot number: GH9693) at the age of 41 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "if COVID prior vaccination: Yes" (unspecified if ongoing), notes: if COVID prior vaccination: Yes. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: 30155BA, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 05Nov2021, when the patient was 40-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 01Apr2021, when the patient was 40-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 11Mar2021, when the patient was 40-year-old, for COVID-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 21Sep2022 at 19:00, outcome "recovering", described as "Allergy symptoms"; NASOPHARYNGITIS (non-serious) with onset 21Sep2022 at 19:00, outcome "recovering", described as "Cold"; VACCINATION SITE PAIN (non-serious) with onset 21Sep2022 at 19:00, outcome "recovering", described as "Soreness at injection site."; FATIGUE (non-serious) with onset 21Sep2022 at 19:00, outcome "recovering", described as "Tiredness". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination site pain, nasopharyngitis, hypersensitivity, fatigue.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications patient had received within 2 weeks of vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bipolar disorder, Chronic obstructive pulmonary disease, Cough
Clinical narrative: Does have a mental illness problem, bipolar manic depression.; COPD; cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "bipolar" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BIPOLAR DISORDER (medically significant), outcome "unknown", described as "Does have a mental illness problem, bipolar manic depression."; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (medically significant), outcome "unknown", described as "COPD"; COUGH (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201182963 same patient and event; different vaccine dose;US-PFIZER INC-PV202200032637 same patient, different vaccine dose and event;
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: Mild shortness of breath occurring within 15 minutes after dose and lasting approximately 7 hours.  Worsened with exercise; booster; booster; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 at 11:15 as dose 4 (booster), single (Lot number: GJ2524) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZINC; VITAMIN C [ASCORBIC ACID]; VITAMIN D [COLECALCIFEROL]; ESCITALOPRAM [ESCITALOPRAM OXALATE]. Vaccination history included: moderna (Dose Number: 3, Batch/Lot No: 070H21A, Location of injection: Arm Right), administration date: 22Dec2021, when the patient was 48-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; moderna (Dose Number: 2, Batch/Lot No: 025B21A, Location of injection: Arm Right), administration date: 19Apr2021, when the patient was 48-year-old, for COVID-19 immunization; moderna (Dose Number: 1, Batch/Lot No: 008B212A, Location of injection: Arm Left), administration date: 22Mar2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 21Sep2022 at 11:15, outcome "unknown"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 21Sep2022 at 11:15, outcome "unknown" and all described as "booster"; DYSPNOEA (non-serious) with onset 21Sep2022 at 11:45, outcome "recovered", described as "Mild shortness of breath occurring within 15 minutes after dose and lasting approximately 7 hours.  Worsened with exercise". Therapeutic measures were not taken as a result of dyspnoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19.