chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus after each dose; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Tinnitus after each dose) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (breaks into pinkish rash). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced TINNITUS (Tinnitus after each dose). At the time of the report, TINNITUS (Tinnitus after each dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Carbohydrate antigen 125: Normal. In November 2020, Carbohydrate antigen 19-9: normal. In November 2020, Carcinoembryonic antigen: normal. In November 2020, Computerised tomogram: normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient did not had any COVID-19 test or diagnosis previously. Tinnitus after each dose, it was so loud, took 3-4 months. Reporter reported that patient had went to the acupuncturist for Tinnitus.   This case was linked to MOD-2022-613185 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Carbohydrate antigen 125, Carbohydrate antigen 19-9, Carcinoembryonic antigen, Computerised tomogram, Tinnitus
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Tinnitus after each dose/more time the with second dose/tinnitus got louder and worse with each dose/ it was so loud, took 3-4 months to get to a point for me to live with myself) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose recived on 17Jan2021 and second dose recived on 25feb2021) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 028L20A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy (breaks into a pink rash). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TINNITUS (Tinnitus after each dose/more time the with second dose/tinnitus got louder and worse with each dose/ it was so loud, took 3-4 months to get to a point for me to live with myself). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose recived on 17Jan2021 and second dose recived on 25feb2021). At the time of the report, TINNITUS (Tinnitus after each dose/more time the with second dose/tinnitus got louder and worse with each dose/ it was so loud, took 3-4 months to get to a point for me to live with myself) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose recived on 17Jan2021 and second dose recived on 25feb2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Carbohydrate antigen 125: Normal. In November 2020, Carbohydrate antigen 19-9: normal. In November 2020, Carcinoembryonic antigen: normal. In November 2020, Computerised tomogram: normal.         Patient didn't had any COVID-19 test or diagnosis previously. Reporter reported that patient had went to the acupuncturist for Tinnitus.   This case was linked to MOD-2022-612809, MOD-2022-613203 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Carbohydrate antigen 125, Carbohydrate antigen 19-9, Carcinoembryonic antigen, Computerised tomogram, Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Tinnitus after each dose/more time the with second dose/tinnitus got louder and worse with each dose/ it was so loud, took 3-4 months to get to a point for me to live with myself) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose recived on 17Jan2021 and second dose recived on 25feb2021) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 028L20A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy (breaks into a pink rash). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TINNITUS (Tinnitus after each dose/more time the with second dose/tinnitus got louder and worse with each dose/ it was so loud, took 3-4 months to get to a point for me to live with myself). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose recived on 17Jan2021 and second dose recived on 25feb2021). At the time of the report, TINNITUS (Tinnitus after each dose/more time the with second dose/tinnitus got louder and worse with each dose/ it was so loud, took 3-4 months to get to a point for me to live with myself) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose recived on 17Jan2021 and second dose recived on 25feb2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Carbohydrate antigen 125: Normal. In November 2020, Carbohydrate antigen 19-9: normal. In November 2020, Carcinoembryonic antigen: normal. In November 2020, Computerised tomogram: normal.         Patient didn't had any COVID-19 test or diagnosis previously. Reporter reported that patient had went to the acupuncturist for Tinnitus.   This case was linked to MOD-2022-612809, MOD-2022-613203 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Tinnitus after each dose/more time the with second dose/tinnitus got louder and worse with each dose/ it was so loud, took 3-4 months to get to a point for me to live with myself) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose recived on 17Jan2021 and second dose recived on 25feb2021) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 028L20A) for COVID-19 prophylaxis.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy (breaks into a pink rash). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TINNITUS (Tinnitus after each dose/more time the with second dose/tinnitus got louder and worse with each dose/ it was so loud, took 3-4 months to get to a point for me to live with myself). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose recived on 17Jan2021 and second dose recived on 25feb2021). At the time of the report, TINNITUS (Tinnitus after each dose/more time the with second dose/tinnitus got louder and worse with each dose/ it was so loud, took 3-4 months to get to a point for me to live with myself) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose recived on 17Jan2021 and second dose recived on 25feb2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, Carbohydrate antigen 125: Normal. In November 2020, Carbohydrate antigen 19-9: normal. In November 2020, Carcinoembryonic antigen: normal. In November 2020, Computerised tomogram: normal.         Patient didn't had any COVID-19 test or diagnosis previously. Reporter reported that patient had went to the acupuncturist for Tinnitus.   This case was linked to MOD-2022-612809, MOD-2022-613203 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: Patients received Moderna Covid-19 vaccine that underwent a temperature excursion; Patients received Moderna Covid-19 vaccine that underwent a temperature excursion; patients received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Patients received Moderna Covid-19 vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna Covid-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 027H21B, 030L20A and 011J20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patients received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Patients received Moderna Covid-19 vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received Moderna Covid-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (patients 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 medication were provided. The temperature in the refrigerator that the Moderna Covid-19 vaccine reached  to 13.1 degrees Celsius on 28-JUN-2022 and on 19-JUL-2022 the vaccine reached a temperature of 9 degrees Celsius. None of the vaccine in the refrigerator underwent two different temperature excursions. 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. No treatment details were reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 on 23-Jun-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID-19 on 23-Jun-2022) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for COVID-19 on 23-Jun-2022). At the time of the report, COVID-19 (Tested positive for COVID-19 on 23-Jun-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jun-2022, SARS-CoV-2 test: (Positive) Positive with  test type- Abbott ID NOW.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  It was reported as Inquiry was strictly regarding validity of vaccine dose administered after greater than 24 hour exposure to room temperature approximately 27 hours.  No treatment drug were reported.  Company comment: This spontaneous case concerns a 79-year-old female patient with relevant medical history of Type 2 diabetes mellitus, who experienced the unexpected non-serious AESI of Covid-19, 7 months 22 days after receiving the 3rd dose of mRNA-1273 vaccine. SARS-CoV-2 test was positive. The outcome was reported as unknown. Details of clinical course, further investigation reports and treatment were not provided. Elderly age and medical history of type2 diabetes mellitus could be risk factors. Nine months prior to the 3rd dose, the patient had received the primary doses of mRNA-1273 vaccine. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-610672 (Patient Link).; Sender's Comments: This spontaneous case concerns a 79-year-old female patient with relevant medical history of Type 2 diabetes mellitus, who experienced the unexpected non-serious AESI of Covid-19, 7 months 22 days after receiving the 3rd dose of mRNA-1273 vaccine. SARS-CoV-2 test was positive. The outcome was reported as unknown. Details of clinical course, further investigation reports and treatment were not provided. Elderly age and medical history of type2 diabetes mellitus could be risk factors. Nine months prior to the 3rd dose, the patient had received the primary doses of mRNA-1273 vaccine. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 50.0
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A and 058F21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Janssen (Dose no: 1 andBatch no 1808980.) on 09-Apr-2021. Past adverse reactions to the above products included No adverse reaction with Janssen.   On 23-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-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, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (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. The side effects after the doses was reported as unknown. No treatment medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: 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 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-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 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 has used the online Temperature excursion tool and was comfortable that her patient dose was valid and that the affected vaccine was viable for future doses. Side effects after any doses was unknown. Excursion vaccination date was 08-Jul-2022 with batch number 014B22A. No treatment medications were reported.
Age: 82.0
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna COVID-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna COVID-19 vaccine that underwent a temperature excursion) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 037F21A, 022M20A and 007M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-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, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna COVID-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (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.   Concomitant medication of the patient was not reported.   The temperature in the refrigerator where the Moderna COVID-19 vaccine was kept was reached 13.1 degrees Celsius on 28-Jun-2022. On 19-Jul-2022, the vaccine reached a temperature of 9 degrees Celsius. None of the vaccine in the refrigerator underwent two different temperature excursions.  The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found after a review of the temperature datalogger on the refrigerator, where the Moderna COVID-19 vaccine was stored.  The reporter used the online temperature excursion tool and was comfortable that the dose which was received by the patient was valid and the affected vaccine was viable for future doses.  It was unknown if the patient had side effects after any dose.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-611891  Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-611891:Master case
Age: 80.0
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 an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 037F21A, 022M20A and 007M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-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 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 dose was valid and that the affected vaccine was viable for future doses. Side effects after any doses was unknown.  No treatment medications were reported.
Age: 49.0
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 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Janssen Vaccine (Batch number- 1808980) on 05-May-2021. Past adverse reactions to the above products included No adverse event with Janssen Vaccine.    On 06-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-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. Patient's weight was unknown. It was reported that 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 has used the online Temperature excursion tool and was comfortable that her patient dose was valid and that the affected vaccine was viable for future doses. Side effects after any doses was unknown. No treatment medications were reported.
Age: 80.0
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 PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 067F21A, 038B21A and 040A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-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 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022, received fourth 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (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 information was reported.  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 and on 19-Jul-2022, the vaccine reached a temperature of 9 degrees Celsius. None of the vaccine in the refrigerator underwent two different temperature excursions.  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 dose was valid and that the affected vaccine was viable for future doses.  Side effects after any dose was reported as unknown.  No treatment medications were provided.
Age: 81.0
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 an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 040A21A, 038B21A and 067F21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 19-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 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022, received fourth 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 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.  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.
Age: 63.0
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 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Janssen (Batch number-1855835 and Dose 1.) on 18-Jan-2022. Past adverse reactions to the above products included No adverse event with Janssen.    On 01-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-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 information was reported.  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 and on 19-Jul-2022, the vaccine reached a temperature of 9 degrees Celsius. None of the vaccine in the refrigerator underwent two different temperature excursions.  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 patients doses were valid and that the affected vaccine was viable for future doses.  Side effects after any dose was reported as unknown.  No treatment medications were provided.
Age: 95.0
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 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 067F21A, 015M20A and 007M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-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.   Concomitant product use was not provided by the reporter.  Patient's weight was unknown. It was reported that 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 dose was valid and that the affected vaccine was viable for future doses. Side effects after any of the doses were unknown. No treatment information was provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient took Moderna first dose on 4-MAY-2021 and second dose on 23-Jun-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Moderna first dose on 4-MAY-2021 and second dose on 23-Jun-2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A 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 23-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Moderna first dose on 4-MAY-2021 and second dose on 23-Jun-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took Moderna first dose on 4-MAY-2021 and second dose on 23-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.  Side effects after any doses was unknown.  No treatment medications were reported.   This case was linked to MOD-2022-612826 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: realized after the fact it was a little past 24 hours sitting out/Dose administered after exposure to room temperature more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (realized after the fact it was a little past 24 hours sitting out/Dose administered after exposure to room temperature more than 24 hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (realized after the fact it was a little past 24 hours sitting out/Dose administered after exposure to room temperature more than 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (realized after the fact it was a little past 24 hours sitting out/Dose administered after exposure to room temperature more than 24 hours) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Patient accidently got a Moderna booster vaccine on 21-Jul-2022. On 16-JUL-2022,the vial was initially stored in the refrigerator. The vial doesn't undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree to 25 degree Celsius = 46 degree to 77 degree Fahrenheit) 25 or 26 hours. Treatment information was not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patient received Moderna Covid-19 vaccine that under went a temperature excursion.; Patient received Moderna Covid-19 vaccine that under went 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 under went a temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that under went a temperature excursion.) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 007D21A, 012L20A and 025J20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022, received 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 under went a temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that under went a temperature excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that under went a temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that under went 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 in the refrigerator that the Moderna Covid-19 vaccine reached 13.1 degrees Celsius on 28-Jun-2022. None of the vaccine in the refrigerator underwent two different temperature excursions. 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 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 the patient had any side effects after any dose.  No treatment details were reported.