chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 060A22A, 067F21A, 016M20A and 030L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-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 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) 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 reported that the temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna Covid-19 vaccine was stored in. The Nurse has used the online temperature excursion tool and is comfortable that her patients doses are valid and that the affected vaccine is viable for future doses.  The Nurse had discovered temperature excursions of the Moderna Covid-19 vaccine in the refrigerator reached to 13.1 degrees Celsius on 28 JUN 2022.None of the vaccine in the refrigerator underwent two different temperature excursions.  The side effects after vaccination with any dose was unknown.   No treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of inappropriate schedule of product administration (patient took Moderna first dose on Jan 28, 2021 and second dose on Mar 5, 2021) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 013M20A and 007M20A) for COVID-19 immunization. No medical history reported. On Jan 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 5, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 5, 2021, patient experienced inappropriate schedule of product administration (patient took Moderna first dose on Jan 28, 2021 and second dose on Mar 5, 2021). At the time of the report, inappropriate schedule of product administration (patient took Moderna first dose on Jan 28, 2021 and second dose on Mar 5, 2021) outcome unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2022-612869 (patient link).
Age: 0.75
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 20-Jun-2022, administration of vaccine on 22-Jul-2022; patients received doses after its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 20-Jun-2022, administration of vaccine on 22-Jul-2022) in a 9-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 22-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 20-Jun-2022, administration of vaccine on 22-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 20-Jun-2022, administration of vaccine on 22-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial did not undergo any temperature excursions. It was reported that 4 does were given from 1 vial. No treatment medication was reported.
Age: 0.75
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: vial was initially stored in the refrigerator on 20-Jun-2022, administration of vaccine on 22-Jul-2022; patients received doses after its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 20-Jun-2022, administration of vaccine on 22-Jul-2022) in a 9-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 22-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 20-Jun-2022, administration of vaccine on 22-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 20-Jun-2022, administration of vaccine on 22-Jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial did not undergo any temperature excursions. It was reported that 4 does were given from 1 vial. No treatment medication was reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 023C21A and DA123A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) 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 reported that, the nurse had discovered 2 temperature excursions of the Moderna COVID-19 vaccine for two different lot numbers of the Moderna COVID-19 vaccine. The temperature in the refrigerator that the Moderna COVID-19 vaccine reached 13.1 degrees Celsius on 28-Jun-2022. On 19-Jul-2022, the vaccine reached a temperature of 9 degrees Celsius. Further nurse stated that, none of the vaccine in the refrigerator underwent two different temperature excursions.  Later, the patient received Moderna COVID-19 vaccine that underwent a temperature excursion. The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna COVID-19 vaccine was stored in. The nurse had used the online temperature excursion tool and was comfortable that her patient's doses were valid and that the affected vaccine was viable for future doses.  It was unknown if patient had side effects after any dose.  No treatment medications were reported.   This case was linked to MOD-2022-612877 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 15-May-2021 and 2nd dose on 29-Jun-2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and DA123A) for COVID-19 prophylaxis. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 15-May-2021 and 2nd dose on 29-Jun-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st dose on 15-May-2021 and 2nd dose on 29-Jun-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.  It was unknown if the patient had any side effects after administration of doses.  No treatment medications were reported.   This case was linked to MOD-2022-612876 (Patient Link).
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial was initially stored in the refrigerator Jun 20 2022; receiving doses after its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator Jun 20 2022) in a 2-year-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 22-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator Jun 20 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator Jun 20 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Total 4 doses from 1 vial were administered to 4 patients. The vial was initially stored in the refrigerator on Jun-20-2022. The vial did not undergo any temperature excursions              No treatment information was provided by the reporter
Age: 2.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: vial was initially stored in the refrigerator Jun 20 2022; receiving doses after its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator Jun 20 2022) in a 2-year-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 22-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator Jun 20 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator Jun 20 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Total 4 doses from 1 vial were administered to 4 patients. The vial was initially stored in the refrigerator on Jun-20-2022. The vial did not undergo any temperature excursions              No treatment information was provided by the reporter
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 20-6-2022 and administered on 22-jul-2022; receiving doses after its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-6-2022 and administered on 22-jul-2022) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-6-2022 and administered on 22-jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 20-6-2022 and administered on 22-jul-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. It was reported that 4 does were given from 1 vial. The vial did not undergo any temperature excursions. No treatment drug details was reported.
Age: 2.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient received doses after its beyond use date from 1 vial lot AS1414B/Date the vial was initially stored in the refrigerator was 20-Jun-2022; received dose after its beyond use date/gave expired doses of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date/gave expired doses of the vaccine) and PRODUCT STORAGE ERROR (Patient received doses after its beyond use date from 1 vial lot AS1414B/Date the vial was initially stored in the refrigerator was 20-Jun-2022) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date/gave expired doses of the vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received doses after its beyond use date from 1 vial lot AS1414B/Date the vial was initially stored in the refrigerator was 20-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date/gave expired doses of the vaccine) and PRODUCT STORAGE ERROR (Patient received doses after its beyond use date from 1 vial lot AS1414B/Date the vial was initially stored in the refrigerator was 20-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 20-Jun-2022. It was reported that the vial did not undergo any temperature excursions.
Age: 2.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received doses after its beyond use date from 1 vial lot AS1414B/Date the vial was initially stored in the refrigerator was 20-Jun-2022; received dose after its beyond use date/gave expired doses of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date/gave expired doses of the vaccine) and PRODUCT STORAGE ERROR (Patient received doses after its beyond use date from 1 vial lot AS1414B/Date the vial was initially stored in the refrigerator was 20-Jun-2022) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date/gave expired doses of the vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received doses after its beyond use date from 1 vial lot AS1414B/Date the vial was initially stored in the refrigerator was 20-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose after its beyond use date/gave expired doses of the vaccine) and PRODUCT STORAGE ERROR (Patient received doses after its beyond use date from 1 vial lot AS1414B/Date the vial was initially stored in the refrigerator was 20-Jun-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 20-Jun-2022. It was reported that the vial did not undergo any temperature excursions.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: patient received Moderna Covid-19 vaccine that underwent a temperature excursion; patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR5186C, 018B21A and 047A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (patient received Moderna Covid-19 vaccine that underwent a temperature excursion) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient weight was reported as unknown. It was reported that, the nurse had discovered temperature excursions of the Moderna COVID-19 vaccine. The temperature in the refrigerator that the Moderna COVID-19 vaccine reached 13.1 degrees Celsius on 28-Jun-2022. Further nurse stated that, none of the vaccine in the refrigerator underwent two different temperature excursions. It was reported that the patient received Moderna Covid-19 vaccine that underwent a temperature excursion. The temperature excursion was not known at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna Covid-19 vaccine was stored in. The nurse had used the online temperature excursion tool and was comfortable that her patient's doses were valid and that the affected vaccine was viable for future doses. Side effects after the doses was reported as unknown. No treatment medications were reported.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) 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 reported that, the nurse had discovered 2 temperature excursions of the Moderna COVID-19 vaccine for two different lot numbers of the Moderna COVID-19 vaccine. The temperature in the refrigerator that the Moderna COVID-19 vaccine reached 13.1 degrees Celsius on 28 Jun 2022. On 19 Jul 2022, the vaccine reached a temperature of 9 degrees Celsius. Further nurse stated that, none of the vaccine in the refrigerator underwent two different temperature excursions.  Later, it was reported the patient received Moderna COVID-19 vaccine that underwent a temperature excursion. The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna COVID-19 vaccine was stored in. The nurse had used the online temperature excursion tool and was comfortable that her patient's doses were valid and that the affected vaccine was viable for future doses.  It was unknown if patient had side effects after dose received.   No treatment medications were reported.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Inappropriate schedule of product administration, Malaise, Vaccination site pain
Clinical narrative: The child was given Moderna COVID-19 vaccine as a booster; Generalized malaise; Diarrhea; Soreness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (Generalized malaise), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Soreness at the injection site) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The child was given Moderna COVID-19 vaccine as a booster) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer-BNT 10 mcg on 09-Nov-2021 and Pfizer-BNT 10 mcg on 01-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer-BNT 10 mcg and Pfizer-BNT 10 mcg.    On 12-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The child was given Moderna COVID-19 vaccine as a booster). In July 2022, the patient experienced MALAISE (Generalized malaise), DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Soreness at the injection site). In July 2022, MALAISE (Generalized malaise), DIARRHOEA (Diarrhea) and VACCINATION SITE PAIN (Soreness at the injection site) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The child was given Moderna COVID-19 vaccine as a booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history information or past illness for the patient was reported. No concomitant medications were reported. The patient received Moderna-Booster 50 mcg. No treatment medications were reported.   This case was linked to MOD-2022-613069, MOD-2022-613065 (Patient Link).
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 6-year patient was administered Moderna COVID-19 vaccine as a Booster; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6-year patient was administered Moderna COVID-19 vaccine as a Booster) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer on 10-Nov-2021 and Pfizer on 01-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 13-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6-year patient was administered Moderna COVID-19 vaccine as a Booster). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (6-year patient was administered Moderna COVID-19 vaccine as a Booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The patient received Moderna-Booster 50 mcg.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-613069, US-MODERNATX, INC.-MOD-2022-612998 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-613069: Male, 6 years old (Same reporter) US-MODERNATX, INC.-MOD-2022-612998: Female, 6 years old (Same reporter)
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was administered Moderna COVID-19 vaccine as a booster; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered Moderna COVID-19 vaccine as a booster) in a 6-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFizer (Pfizer-BNT 10mcg) on 10-Nov-2021 and PFIZER BIONTECH COVID-19 VACCINE (Pfizer-BNT 10mcg) on 01-Dec-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFizer.    On 13-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered Moderna COVID-19 vaccine as a booster). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient was administered Moderna COVID-19 vaccine as a booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. Patient received booster vaccine 50 mcg on 13-Jul-2022. No treatment medication information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-612998 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-612998:AA Female, 6 years old (Same reporter)
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or the vaccine was store after manufacturer date of expiry; HCP administer the vaccine to patient, after the expiration on the 5Jul2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administer the vaccine to patient, after the expiration on the 5Jul2022) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or the vaccine was store after manufacturer date of expiry) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administer the vaccine to patient, after the expiration on the 5Jul2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or the vaccine was store after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administer the vaccine to patient, after the expiration on the 5Jul2022) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or the vaccine was store after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Patient was never tested positive for COVID. No medical history reported, related to mentioned AE both Acute and Chronic illnesses at the time of vaccination. Information about other vaccines given within 1 month prior to Moderna COVID-19 vaccine was unknown. Patient did not experienced a similar event in the past. Date the vial was initially stored in the refrigerator on 31-May-2022. The vial did not undergo any temperature excursions.   No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2022-613384 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-613384:(same reporter)
Sex: U
Vaccine: COVID19
Symptoms: Occupational exposure to product
Clinical narrative: Pharmacist accidentally had eye contact with the Moderna COVID-19 Vaccine while administering the vaccine to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of OCCUPATIONAL EXPOSURE TO PRODUCT (Pharmacist accidentally had eye contact with the Moderna COVID-19 Vaccine while administering the vaccine to a patient) in a  patient of an unknown age and gender 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. On 25-Jul-2022, the patient experienced OCCUPATIONAL EXPOSURE TO PRODUCT (Pharmacist accidentally had eye contact with the Moderna COVID-19 Vaccine while administering the vaccine to a patient). At the time of the report, OCCUPATIONAL EXPOSURE TO PRODUCT (Pharmacist accidentally had eye contact with the Moderna COVID-19 Vaccine while administering the vaccine to a patient) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   It was unknown if patient was under any concomitant or regular medication.  It was unknown if pharmacist experienced additional symptoms after occupational exposure. It was unknown if any treatment was given besides Moderna Safety Data Sheet recommendations.   Reporter did not allow further contact
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered with the vaccine that has been stored in the refrigerator for more than 30 days; Administered with the vaccine that has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered with the vaccine that has been stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (Administered with the vaccine that has been stored in the refrigerator for more than 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Patient had received second booster.  Pharmacist reported that they administered 7 doses of the COVID-19 vaccine that had been stored in the refrigerator for more than 30 days. The vaccine was initially stored in the refrigerator on 15-Jun-2022 and administered on two dates 19-Jul-2022 (3 doses on 11:11AM, 11:15AM, 02:27PM), 20-Jul-2022 (4 doses on 09:43AM, 01:31PM, 03:05 PM, 06:18 PM).  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2022: Follow-up received as patient details and product information was updated.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose of Moderna covid19 vaccine was taken on Feb-2021, second dose was taken on the May-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna covid19 vaccine was taken on Feb-2021, second dose was taken on the May-2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Morphine allergy).   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna covid19 vaccine was taken on Feb-2021, second dose was taken on the May-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose of Moderna covid19 vaccine was taken on Feb-2021, second dose was taken on the May-2021) outcome was unknown.            No relevant concomitant medications were reported. No other medical history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination. The AE did not cause the patient to seek medical care (office visit, urgent care, ER, hospitalized). Patient did not experienced a similar event in the past. Treatment information was not provided by the reporter.   This case was linked to MOD-2022-613380 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; HCP administer the vaccine to patient, after the expiration on the 5Jul2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP administer the vaccine to patient, after the expiration on the 5Jul2022) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in an 81-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 045L21A) for COVID-19 prophylaxis.     The patient had no allergies (medications,food and other products). The patient had no history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination and never had COVID-19 positive test or diagnosis. The patient had no other vaccines given within 1 month prior to Moderna COVID-19 vaccine.     On 15-Jul-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP administer the vaccine to patient, after the expiration on the 5Jul2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP administer the vaccine to patient, after the expiration on the 5Jul2022) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The adverse effect did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalization). The patient did not experience a similar event in the past. On 31-May-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Treatment information was unknown.   This case was linked to MOD-2022-613364 (Patient Link).
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds; 19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds) and INCORRECT DOSE ADMINISTERED (19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. AS1414B and 059M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jun-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Jul-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 25-Jul-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds) and INCORRECT DOSE ADMINISTERED (19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds) and INCORRECT DOSE ADMINISTERED (19 Year old patient received 0,5mL second dose from the vial for 6 mo to 5 years olds) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient Height was reported as 5 feet and 5 inches. Patient had no Allergies  No Concomitant medications were provided. It was reported that HCP accidentally vaccinated a 19 Year old patient from a vial for 6 mo to 5 years old children. patient never had COVID positive test or diagnosis.  No treatment medications were provided.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Fatigue, Product storage error
Clinical narrative: Dose administered >12/24 hours post puncture; The patient received a dose of the Moderna Covid-19 vaccine that had been first punctured greater than 12 hours ago; Tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Tiredness), EXPIRED PRODUCT ADMINISTERED (The patient received a dose of the Moderna Covid-19 vaccine that had been first punctured greater than 12 hours ago) and PRODUCT STORAGE ERROR (Dose administered >12/24 hours post puncture) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2022, the patient experienced FATIGUE (Tiredness). On 25-Jul-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose of the Moderna Covid-19 vaccine that had been first punctured greater than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered >12/24 hours post puncture). At the time of the report, FATIGUE (Tiredness), EXPIRED PRODUCT ADMINISTERED (The patient received a dose of the Moderna Covid-19 vaccine that had been first punctured greater than 12 hours ago) and PRODUCT STORAGE ERROR (Dose administered >12/24 hours post puncture) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator on 22-Jul-2022. The vial was first punctured on 22-Jul-2022 at 3:40 PM. The vial did not undergo any temperature excursions. The vial was stored in refrigerator post puncture. The total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): one to two minutes on both 22-JUL-2022 and 25-JUL-2022. It was reported that patient had no adverse reactions to her first dose. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2022: Live Follow-up contains significant information: reporter information, patient information updated and event(tiredness) added.