chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 1Jun2022; administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients.) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 1Jun2022) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 041C21A and 005C21a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 1Jun2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer the vaccine  from a vial that  was open on 1Jun2022 to 6 patients.) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 1Jun2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergies. It was unknown if patient ever had COVID + test or diagnosis. No other vaccines were taken within 1 month prior to Moderna COVID-19 vaccine No concomitant medication were reported.  The vial was initially stored in the refrigerator on 1-Jun-2022. The vial did not undergo any temperature excursions.       No treatment information was provided by the reporter.
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patients that received a dose administered  more than 12 hours post puncture; patients that received a dose administered  more than 12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (patients that received a dose administered  more than 12 hours post puncture) and EXPIRED PRODUCT ADMINISTERED (patients that received a dose administered  more than 12 hours post puncture) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 060A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2022 at 7:25 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients that received a dose administered  more than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patients that received a dose administered  more than 12 hours post puncture). At the time of the report, PRODUCT STORAGE ERROR (patients that received a dose administered  more than 12 hours post puncture) and EXPIRED PRODUCT ADMINISTERED (patients that received a dose administered  more than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator was 29-Jun-2022 The vial was first punctured was 6-Jul-2022 7:49am EST The date of administration of vaccine was 7-Jul-2022 7:25am and 7:45am The vial stored in fridge post puncture. The vial was not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius = 46 degree to 77 degree F) was Less than 30/45 minutes The vial was not exposed to room temperature for more than 24 hours. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-614415 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-614415:2nd patient
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received First vaccine dose of the Moderna COVID-19 on the 29 Sep 2021 and second dose on 12 Nov 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First vaccine dose of the Moderna COVID-19 on the 29 Sep 2021 and second dose on 12 Nov 2021) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 045C21A) for COVID-19 prophylaxis.     The patient had no allergies to medications, food and other products. The patient had no medical history related to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. The patient had not received any other vaccine within 1 month prior to administration of Moderna COVID-19 vaccine. It was unknown whether the patient was ever tested positive or diagnosed with COVID-19 or not.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First vaccine dose of the Moderna COVID-19 on the 29 Sep 2021 and second dose on 12 Nov 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received First vaccine dose of the Moderna COVID-19 on the 29 Sep 2021 and second dose on 12 Nov 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-615335 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Caught COVID-19 this year (2022) after being vaccinated with Moderna's COVID-19) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (Caught COVID-19 this year (2022) after being vaccinated with Moderna's COVID-19). At the time of the report, COVID-19 (Caught COVID-19 this year (2022) after being vaccinated with Moderna's COVID-19) outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant medications were reported. No additional adverse events reported. No product quality complaints reported. No treatment information was reported. Company comment: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the non-serious unexpected adverse event of special interest of COVID-19 after receiving a dose of mRNA-1273 vaccine. There is no information available regarding dose number or further COVID-19 vaccination schedule. Vaccination date or event onset date were not provided; hence latency cannot be assessed. No other information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a female patient of unknown age, with no medical history reported, who experienced the non-serious unexpected adverse event of special interest of COVID-19 after receiving a dose of mRNA-1273 vaccine. There is no information available regarding dose number or further COVID-19 vaccination schedule. Vaccination date or event onset date were not provided; hence latency cannot be assessed. No other information was available for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site reaction
Clinical narrative: Sored arm; Tiredness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (Sored arm) and FATIGUE (Tiredness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 016B21A and 025A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2022, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (Sored arm) and FATIGUE (Tiredness). At the time of the report, VACCINATION SITE REACTION (Sored arm) and FATIGUE (Tiredness) outcome was unknown.            No concomitant medication reported.  Patient states that with the previous dose 2nd primary and first booster doses  she just experienced sored arm and tiredness. She did not take any treatment for these symptoms.   This case was linked to MOD-2022-615640 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; patient was immunocompromised and did not got their third shot, got only the primary series and two booster; This spontaneous case was reported by a nurse and describes the occurrence of NO ADVERSE EVENT (No adverse event) and INCORRECT DOSE ADMINISTERED (patient was immunocompromised and did not got their third shot, got only the primary series and two booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, 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 NO ADVERSE EVENT (No adverse event) and INCORRECT DOSE ADMINISTERED (patient was immunocompromised and did not got their third shot, got only the primary series and two booster). At the time of the report, NO ADVERSE EVENT (No adverse event) and INCORRECT DOSE ADMINISTERED (patient was immunocompromised and did not got their third shot, got only the primary series and two booster) 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 INCORRECT DOSE ADMINISTERED (patient was immunocompromised and did not got their third shot, got only the primary series and two booster).    No concomitant medications were reported.  The patient left a voice message in which the patient asked to receive a third booster dose of Moderna vaccine.  It was reported that the patient was immunocompromised and did not got the third shot, and received only the primary series and two booster doses (first and second booster doses).  No treatment medications were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was never put it in the refrigerator; No Adverse event; Vaccine administered to the patient after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vial was never put it in the refrigerator), EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient after expiration date) and NO ADVERSE EVENT (No Adverse event) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 062E21A, 011M20A and 013L20A) for COVID-19 prophylaxis.     The patient had no allergies to medications, food and other products. The patient had no medical history related to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. The patient had not received any other vaccine within 1 month prior to administration of Moderna COVID-19 vaccine. The patient had not experienced any similar event in the past.  It was unknown whether the patient was ever tested positive or diagnosed with COVID-19 or not.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was never put it in the refrigerator) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vial was never put it in the refrigerator), EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient after expiration date) 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 PRODUCT STORAGE ERROR (Vial was never put it in the refrigerator) and EXPIRED PRODUCT ADMINISTERED (Vaccine administered to the patient after expiration date).    No concomitant medications were reported. It was reported that the vial was never put in the refrigerator.  The vial did not undergone any temperature excursions. Adverse event did not caused patient to seek medical care. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-615657 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615657:Same Reporter (Patient -)
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date of administration of vaccine was on 27Jul2022, The expiration date original stated 31Dec2069/ They never put it in the refrigerator; Administering to two patients a vaccine after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administering to two patients a vaccine after expiration date) and PRODUCT STORAGE ERROR (Date of administration of vaccine was on 27Jul2022, The expiration date original stated 31Dec2069/ They never put it in the refrigerator) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 062E21A, 011M20A and 013L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administering to two patients a vaccine after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date of administration of vaccine was on 27Jul2022, The expiration date original stated 31Dec2069/ They never put it in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administering to two patients a vaccine after expiration date) and PRODUCT STORAGE ERROR (Date of administration of vaccine was on 27Jul2022, The expiration date original stated 31Dec2069/ They never put it in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no allergies. The patient has not experienced any similar event in the past. Patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. No concomitant medications were provided. Date the vial was initially stored in the refrigerator was that they never put it in the refrigerator.  The vial did not undergone any temperature excursions. Adverse event outcome was reported as recovered. Adverse event did not caused patient to seek medical care. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-615655 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615655:Same Reporter (Patient
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Expired product administered, Product storage error
Clinical narrative: On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am; Second dose taken as 0.5 ml; On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am), PRODUCT STORAGE ERROR (On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am) and ACCIDENTAL OVERDOSE (Second dose taken as 0.5 ml) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B and AS1414B) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Jul-2022 at 8:52 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 28-Jul-2022 at 8:52 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am). 28-Jul-2022 at 8:52 AM, the patient experienced ACCIDENTAL OVERDOSE (Second dose taken as 0.5 ml). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am), PRODUCT STORAGE ERROR (On 27-Jul-2022 1:47 pm vial was first punctured and administered on 28-Jul-2022 8:52 am) and ACCIDENTAL OVERDOSE (Second dose taken as 0.5 ml) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient height was reported as 38' 3 1/4''.  The patient had no known allergies. It was unknown whether the patient had been diagnosed or tested positive for COVID 19.  No acute illness at the time of vaccination and up to one month before.  No chronic or long standing health conditions were reported.  No concomitant medication was taken by the patient.  No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  On 27-Jul-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. It was unknown if the vial was exposed to room temperature for more than 24 hours.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: The patient thinks they got dose SQ vs IM, because the vaccinator pinched her arm while giving the injection.; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The patient thinks they got dose SQ vs IM, because the vaccinator pinched her arm while giving the injection.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if the patient had any allergies to medications, food, and other products.  It was unknown if the patient ever had COVID positive test or diagnosis. It was unknown if the patient had a medical history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The patient thinks they got dose SQ vs IM, because the vaccinator pinched her arm while giving the injection.). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (The patient thinks they got dose SQ vs IM, because the vaccinator pinched her arm while giving the injection.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was unknown if any other vaccines were given to the patient within 1 month prior to Moderna COVID-19 vaccine.  The reporter stated that the patient think they got dose SQ (subcutaneous) vs IM (intramuscular), because the vaccinator pinched her arm while giving the injection. It was also reported that the patient wanted to be revaccinated. Reportedly, the patient received their second booster dose.  It was unknown if the adverse event caused the patient to seek medical care. It was unknown if the patient experienced a similar event in the past. It was unknown if the symptoms had improved or worsened.  No treatment information was provided by the reporter.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered a Moderna vaccine to a 16 year old as a booster shot; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered a Moderna vaccine to a 16 year old as a booster shot) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered a Moderna vaccine to a 16 year old as a booster shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (administered a Moderna vaccine to a 16 year old as a booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient got the booster dose after getting the first and second dose of a COVID-19 vaccine, they don't know if they got the Moderna or Pfizer vaccine as the primary doses.   No concomitant medication information provided.  Patient had not reported anything after receiving the dose.  No treatment medication information provided.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul 2022; Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul 2022) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was vaccinated with the Moderna Covid 19 vaccine past its best use by date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 13-Jun-2022 and administered on Jul 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   This case contains information of the seventh patient out of 12 patients who received the vaccine on Jul-2022 as described by the reporter.  No concomitant medication information was provided.  Number of patients who received the vaccine beyond usage date were 12 patients.  Number of doses/vials that were affected were 3 vials and 12 doses.  The vial was initially stored in the refrigerator on 13-Jun-2022.  The number of patients who received the vaccine on 16-Jul-2022 was 3, the number of patients who received the vaccine on 23-Jul-2022 was 5 and the number of patients who received the vaccine on 24-Jul-2022 was 4.  The vial did not undergo any temperature excursion.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Live Follow Up received, reporter details and narrative updated.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date; 12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date) and PRODUCT STORAGE ERROR (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date) and PRODUCT STORAGE ERROR (12 People were vaccinated with the Moderna Covid 19 vaccine past its beyond use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Number of doses, vials reported  were 3 vials and 12 doses.  The dates of administration and number patients were reported as on 16-Jul-2022 to 3 patients, on 23-Jul-2022 to 5 patients, on 24-Jul-2022 to 4 patients.  All the vials were moved to fridge on the same day on 13-Jun-2022.  The vial did not undergo any temperature excursions.  No treatment medication was provided.  This case contains information for the 9th of the 12 patients who received the vaccine on Jul-2022 as described by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2022: Follow up received and Narrative updated.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product storage error
Clinical narrative: Date vials moved from freezer to refrigerator on 15-Jun-22 and administered on 19-Jul-22; doses given after the 30 day beyond use date; Dose 1 and Dose 2 received 36 days apart; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 received 36 days apart) and PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15-Jun-22 and administered on 19-Jul-22) in a 22-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 060A22A and 05HA22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Jun-2022 at 12:12 PM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 19-Jul-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 19-Jul-2022,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 received 36 days apart). On 19-Jul-2022 at 12:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15-Jun-22 and administered on 19-Jul-22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 received 36 days apart) and PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15-Jun-22 and administered on 19-Jul-22) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Doses were given to an unknown amount of patients on 18-Jul-2022 and 19-Jul-2022. Date vials moved from freezer to refrigerator reported as 15-Jun-2022. No adverse events were reported by the patient. No treatment medication was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID test -tested positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID test -tested positive) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037f21a, 044a21a and 031m20a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID test -tested positive). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID test -tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) positive.         The medical history was not provided by the reporter. Patient had a cataract surgery on 25-Jul-2022 (Monday). Patient took COVID test that was expired on 22-Jul-2022. Concomitant product reported as Vitamins.  Company Comment: This is a spontaneous case concerning a 67-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious of COVID-19 which occurred unknown number of days after receiving a dose of mRNA-1273 Vaccine, first booster in COVID-19 vaccine series. The patient received the primary series of mRNA-1273 vaccine given 28 days apart, the second dose administered about 7 months 22 days before the first booster dose. She was given Zyrtec tablet as treatment. There is no available information regarding clinical course and treatment medication. The patient's elderly age remains a predisposition risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-615736 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 67-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious of COVID-19 which occurred unknown number of days after receiving a dose of mRNA-1273 Vaccine, first booster in COVID-19 vaccine series. The patient received the primary series of mRNA-1273 vaccine given 28 days apart, the second dose administered about 7 months 22 days before the first booster dose. She was given Zyrtec as treatment. There is no available information regarding the clinical course. The patient's elderly age remains a predisposition risk factor for the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Date vials moved from freezer to refrigerator on 15Jun22 and administered on 16Jul22; doses given after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15Jun22 and administered on 16Jul22) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 prophylaxis.     Patient had no known allergies to medications, food and other products.  Unknown if Patient had ever been diagnosed with/ tested positive for COVID-19.  Unknown if Patient had acute illnesses at the time of vaccination and up to one month before vaccine. Unknown if Patient had chronic or long standing health conditions. Unknown if Patient took prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination and/ or at the time of the adverse event.     On 16-Jul-2022 at 10:37 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 16-Jul-2022 at 10:37 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15Jun22 and administered on 16Jul22). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after the 30 day beyond use date) and PRODUCT STORAGE ERROR (Date vials moved from freezer to refrigerator on 15Jun22 and administered on 16Jul22) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. Date vials moved from freezer to refrigerator 15-Jun-2022. It was reported that patient did not have any adverse event. No treatment details were provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Myalgia, Pyrexia
Clinical narrative: still felt bad/still not feels like herself; had a fever; body aches; chills/chills were worst; headache; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (still felt bad/still not feels like herself), MYALGIA (body aches), CHILLS (chills/chills were worst), HEADACHE (headache) and PYREXIA (had a fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017b22a, 031m20a, 044a21a and 037f21a) for COVID-19 vaccination.     The patient's past medical history included Cataract operation on 25-Jul-2022. Concomitant products included VITAMINS NOS for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, the patient experienced MYALGIA (body aches), CHILLS (chills/chills were worst) and HEADACHE (headache). On 27-Jul-2022, the patient experienced FEELING ABNORMAL (still felt bad/still not feels like herself) and PYREXIA (had a fever). The patient was treated with PARACETAMOL (TYLENOL) on 27-Jul-2022 at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (still felt bad/still not feels like herself), MYALGIA (body aches), CHILLS (chills/chills were worst), HEADACHE (headache) and PYREXIA (had a fever) had not resolved.            Patient stated that, she had a reaction "like I normally do". On 27-Jul-2022 patient still felt bad and on 28-Jul-2022 patient still not felt like herself. On 27-JUL-2022 chills were worst, and patient had a fever.   This case was linked to MOD-2022-615675 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vials were refrigerated on 15-Jun-2022, but was administered to patient on 19-Jul-2022; Patient received vaccine after the 30 days beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date) and PRODUCT STORAGE ERROR (Vials were refrigerated on 15-Jun-2022, but was administered to patient on 19-Jul-2022) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 vaccination.     Patient had no known drug allergies.  It was unknown whether the patient ever been diagnosed with/ tested positive for COVID-19.  It was unknown whether the patient had acute illnesses at the time of vaccination and up to one month before.  It was unknown whether the patient had chronic or long-standing health conditions.  t was unknown whether prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event.     On 19-Jul-2022 at 4:40 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 19-Jul-2022 at 4:40 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vials were refrigerated on 15-Jun-2022, but was administered to patient on 19-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date) and PRODUCT STORAGE ERROR (Vials were refrigerated on 15-Jun-2022, but was administered to patient on 19-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (Vials were refrigerated on 15-Jun-2022, but was administered to patient on 19-Jul-2022).    Concomitant medications details were not reported by the reporter.  Patient reported no adverse events.   The events did not cause the patient to seek medical care.  There were no other potential causes.  Patient had not experienced a similar event in the past.  Treatment information was not reported by the reporter
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after the expiration date 05-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after the expiration date 05-Jul-2022) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 prophylaxis.     Allergies (medications, food, and other products) were reported as unknown. It is unknown that patient ever had COVID positive test or diagnosis. Medical History was reported as unknown. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose number) was unknown.     On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after the expiration date 05-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after the expiration date 05-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered with 1st booster dose. No concomitant medications were reported. Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. AE caused patient to seek medical care (office visit, Urgent care, ER, hospitalized) was unknown. The patient experienced a similar event in the past was unknown. AE Outcome (recovered, residual effects, ongoing, unknown) was unknown. Symptoms improved or worsened was unknown. No treatment medications were reported.
Age: 36.0
Sex: U
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 an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 prophylaxis.     It was unknown if patient had any allergies, medical history or if received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. Unknown if patient ever had COVID test or diagnosis.     On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jul-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 (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 (Dose administered after manufacturer date of expiry).    It was reported that patient received 1st booster. Concomitant drugs were not reported. It was reported that patient received various doses. It was also reported that it was unknown if patient had patient experienced a similar event in the past, unknown if patient was hospitalized. It was also unknown if events improved or worsened. It was reported that 7 doses were administered. It was unknown if vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Treatment medications were not provided.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after date of expiry) and NO ADVERSE EVENT (no adverse event) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 prophylaxis. The patient ever had COVID + test or diagnosis was unknown. The AE and both Acute and Chronic illnesses at the time of vaccination was unknown. The Allergies including medications, food, and other products was unknown. On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 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 date of expiry) 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 (Dose administered after date of expiry). No concomitant medications reported. It was reported that 7 doses of Moderna Covid-19 vaccine after the expiration date were administered. The date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was unknown. The AE cause patient to seek medical care that is office visit, Urgent care, ER, hospitalized was unknown. It was unknown if patient experienced a similar event in the past. The cause of death and was autopsy done was unknown. It was unknown if the symptoms improved or worsened.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received vaccine after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 29-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     It was unknown if the patient had allergies to medications, food and other products. It was unknown if the patient ever had COVID positive test or diagnosis. It was unknown if the patient had acute and chronic illnesses at the time of vaccination.     On 22-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.    For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions.  Treatment information was not provided by the reporter.