chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer,vaccine administered to 118 patients; There was an excursion from the freezer,vaccine administered to 118 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to children) in an 8-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 15-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to children). On 15-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Booster dose administered to children) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and Treatment medications was not specified.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Added patient details(initials, age, gender) and vaccine information (dose number, date of vaccination).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Expired vaccine used; Excursion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from freezer) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from freezer). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that, there was excursion from the freezer on 01-Oct-2021 and nurse used the excursion tool but there was no option for the excursion they experienced. The only tool gives the options for excursion above one hour and not less than that so the nurse dose not known about the analysis. The nurse stated that her team know the recommended temperature and wants to know if the vials were still okay to use because they were administered to 118 patients.  The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature reached was as follows; minimum 4.2 degree F and maximum 5.7 degree F. It was also stated that excursion duration was 6 minutes. On visual inspection the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials/doses were impacted and they were moved from freezer to refrigerator only on day they were used and they were not returned to freezer or refrigerator for storage.  No concomitant medications were reported.  No treatment information was reported.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: there was an excursion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from freezer) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.  There was an excursion of vial from their freezer on 01-Oct-2021. The vial was frozen at the time of excursion. The vial size was 7.5 ml. The maximum temperature reached was 5.7 degree Fahrenheit and the minimum temperature reached was 4.2 degree Fahrenheit. The duration of excursion was 6 minutes.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up contains updated patient initials, gender, date of birth and age
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Excursion from the freezer on 01-Oct-2021; Poor quality vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer on 01-Oct-2021) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer on 01-Oct-2021) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Excursion from the freezer on 01-Oct-2021) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: there was an excursion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from freezer) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from freezer). On 08-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excursion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   No treatment information was reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: there was an excrusion from freezer; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (there was an excrusion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment medication was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer and administered to patinet; There was an excursion from the freezer and administered to patinet; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer and administered to patinet) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer and administered to patinet) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer and administered to patinet) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer and administered to patinet). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer and administered to patinet) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer and administered to patinet) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-383410 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from their freezer/they were administered to 118 patients.; There was temperature excursion from  freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from  freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from  freezer). On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from  freezer) had resolved. On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  On 01-Oct-2021, There was temperature excursion from  freezer.   It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received which included patient details (initials, age, gender) and vaccine information ( date of vaccination, dose number).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported  No Treatment information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 67-year-old female patient who received mRNA-1273 (MODERNA COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.  On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  On 01-Oct-2021, There was temperature excursion from  freezer.   It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes.  No treatment medications were provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  On 01-Oct-2021, There was temperature excursion from  freezer.   It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes.  No treatment medications were provided.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  On 01-Oct-2021, There was temperature excursion from  freezer.   It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received on 15-Nov-2021 Contains patient identifiers
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: Semi arthritic pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Semi arthritic pain) and HEADACHE (Headache) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 026821A and 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Semi arthritic pain) and HEADACHE (Headache). At the time of the report, ARTHRALGIA (Semi arthritic pain) and HEADACHE (Headache) had resolved.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer on 01 Oct 2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer on 01 Oct 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer on 01 Oct 2021). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer on 01 Oct 2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment medication were reported.  It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degrees F and Excursion duration was 6 minutes.   .
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered from expired vial; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered from expired vial) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered from expired vial). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported. No Treatment informations were reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Feeling abnormal, Head discomfort, Lacrimation increased
Clinical narrative: eyes watering / eye tearing; can't keep my head up / head stops working; sleeping a minimum of 12 hours at night; extreme back ache; head fog / foggy thinking; fatigue / so tired / too tired to make my bed; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (eyes watering / eye tearing), HEAD DISCOMFORT (can't keep my head up / head stops working), SOMNOLENCE (sleeping a minimum of 12 hours at night), BACK PAIN (extreme back ache) and FEELING ABNORMAL (head fog / foggy thinking) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LACRIMATION INCREASED (eyes watering / eye tearing), HEAD DISCOMFORT (can't keep my head up / head stops working), SOMNOLENCE (sleeping a minimum of 12 hours at night), BACK PAIN (extreme back ache), FEELING ABNORMAL (head fog / foggy thinking) and FATIGUE (fatigue / so tired / too tired to make my bed). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LACRIMATION INCREASED (eyes watering / eye tearing), HEAD DISCOMFORT (can't keep my head up / head stops working), SOMNOLENCE (sleeping a minimum of 12 hours at night), BACK PAIN (extreme back ache), FEELING ABNORMAL (head fog / foggy thinking) and FATIGUE (fatigue / so tired / too tired to make my bed) had not resolved.            No concomitant medications were provided. No treatment medications were provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: eyes watering / eye tearing; can't keep my head up / head stops working; sleeping a minimum of 12 hours at night; extreme back ache; head fog / foggy thinking; fatigue / so tired / too tired to make my bed; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (eyes watering / eye tearing), HEAD DISCOMFORT (can't keep my head up / head stops working), SOMNOLENCE (sleeping a minimum of 12 hours at night), BACK PAIN (extreme back ache) and FEELING ABNORMAL (head fog / foggy thinking) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LACRIMATION INCREASED (eyes watering / eye tearing), HEAD DISCOMFORT (can't keep my head up / head stops working), SOMNOLENCE (sleeping a minimum of 12 hours at night), BACK PAIN (extreme back ache), FEELING ABNORMAL (head fog / foggy thinking) and FATIGUE (fatigue / so tired / too tired to make my bed). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, LACRIMATION INCREASED (eyes watering / eye tearing), HEAD DISCOMFORT (can't keep my head up / head stops working), SOMNOLENCE (sleeping a minimum of 12 hours at night), BACK PAIN (extreme back ache), FEELING ABNORMAL (head fog / foggy thinking) and FATIGUE (fatigue / so tired / too tired to make my bed) had not resolved.            No concomitant medications were provided. No treatment medications were provided.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer). On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer) had resolved. On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of product temperature excursion issue (there was excursion from freezer) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 939901) for COVID-19 immunization. No medical history reported. On Oct 25, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 25, 2021, patient experienced product temperature excursion issue (there was excursion from freezer). On Oct 25, 2021, product temperature excursion issue (there was excursion from freezer) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Used excursion tool but their is no option for the excursion they experienced. Tool only gives option for excursion one hours and not less than.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. No treatment information were provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm after first dose) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore left injection site arm after first dose). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication  was reported.  No treatment medication  was provided for the event happened after first dose.   This case was linked to MOD-2021-387747 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received contains no new information.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an Excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an Excursion from the freezer) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.  On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an Excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an Excursion from the freezer) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was an excursion from the freezer on 01-Oct-2021 and the nurse used the excursion tool but there was no option for the excursion experienced. The only tool gave the options for excursion above one hour and not less than that so the nurse did not known about the analysis. The nurse stated that the team knew the recommended temperature and wanted to know whether the vials were still in a good condition to be used and were administered to 118 patients. The storage condition at the time of the excursion was frozen, vial size was 7.5 mL and maximum or minimum temperature mentioned as minimum minus 4.2 degree Fahrenheit and maximum 5.7 degree Fahrenheit. The excursion duration was 6 minutes. On visual inspection, the vials were thawed before administration and there were no color changes or anything abnormal. Total 10 vials or doses were impacted.  No concomitant medications were reported.  No treatment information was provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Sore left injection site arm after second dose; Feeling feverish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm after second dose) and PYREXIA (Feeling feverish) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm after second dose) and PYREXIA (Feeling feverish). The patient was treated with PARACETAMOL (ACETAMINOPHEN) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore left injection site arm after second dose) and PYREXIA (Feeling feverish) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.   This case was linked to MOD-2021-387737 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: follow-up contains no new information
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer,vaccine administered to 118 patients; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was temperature excursion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was temperature excursion from freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided  On 01-Oct-2021, There was temperature excursion from  freezer.   It was stated 10 Number of vials/doses were impacted. Storage condition at the time of the excursion was frozen and Minimum temperatures reached 4.2 degrees F and maximum was 5.7 degreed F and Excursion duration was 6 minutes.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up Document received on 15-NOV-2021 contains Patient and Suspect Product details and updated.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Expired vaccine used; There was an excrusion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that there was an excursion from the freezer on 1 Oct 2021.  No concomitant medication was reported . No treatment medication was reported .
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Expired vaccine used; Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medication were reported no treatment medication were reported   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up received which included patient details (initials, age, gender) and vaccine information ( date of vaccination, dose number).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was an excursion from their freezer/ Product temperature excursion issue; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer/ Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer/ Product temperature excursion issue). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from their freezer/ Product temperature excursion issue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: There was no excrusion from freezer; There was an excursion from their freezer/they were administered to 118 patients.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was no excrusion from freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was no excrusion from freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was no excrusion from freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-383410 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Added patient details(initials, age, gender) and vaccine information (date of vaccination, dose number)