chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: She was experiencing palpitations/Discomfort in her chest; This spontaneous case was reported by a pharmacist and describes the occurrence of ATRIAL FIBRILLATION (She was experiencing palpitations/Discomfort in her chest) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concomitant products included LOSARTAN, DRONEDARONE HYDROCHLORIDE (MULTAQ) and APIXABAN (ELIQUIS) for an unknown indication.  On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ATRIAL FIBRILLATION (She was experiencing palpitations/Discomfort in her chest) (seriousness criterion medically significant). The patient was treated with CARVEDILOL for Adverse event, at an unspecified dose and frequency. In August 2021, ATRIAL FIBRILLATION (She was experiencing palpitations/Discomfort in her chest) had resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ATRIAL FIBRILLATION (She was experiencing palpitations/Discomfort in her chest) to be possibly related.    Company Comment - This spontaneous case concerns a 51-year-old, female patient with no relevant medical history, who experienced the unexpected, serious AESI of atrial fibrillation. The event occurred approximately 2 hours after administration of the first dose of the Moderna mRNA-1273. The patient presented with chest discomfort and palpitations, and was brought to the emergency room department where she was diagnosed with atrial fibrillation. No information was provided regarding laboratory test/s done. The patient was given fluids and was started on carvedilol. After 2 months, the event resolved. The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Significant Follow Up information included Event added/ Patient details added.; Sender's Comments: This spontaneous case concerns a 51-year-old, female patient with no relevant medical history, who experienced the unexpected, serious AESI of atrial fibrillation. The event occurred approximately 2 hours after administration of the first dose of the Moderna mRNA-1273. The patient presented with chest discomfort and palpitations, and was brought to the emergency room department where she was diagnosed with atrial fibrillation. No information was provided regarding laboratory test/s done. The patient was given fluids and was started on carvedilol. After 2 months, the event resolved. The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Injection site pain
Clinical narrative: Mild injection site Myalgia L delt (1 or 2 out of 10)on scale.; Administered expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of INJECTION SITE PAIN (Mild injection site Myalgia L delt (1 or 2 out of 10)on scale.) and EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced INJECTION SITE PAIN (Mild injection site Myalgia L delt (1 or 2 out of 10)on scale.) and EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 01-Sep-2021, INJECTION SITE PAIN (Mild injection site Myalgia L delt (1 or 2 out of 10)on scale.) and EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever for 12 hours after second Moderna Covid-19 vaccine; sore body aches for 24 hours after second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever for 12 hours after second Moderna Covid-19 vaccine) and MYALGIA (sore body aches for 24 hours after second vaccination) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 039K20-2A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PYREXIA (fever for 12 hours after second Moderna Covid-19 vaccine) and MYALGIA (sore body aches for 24 hours after second vaccination). In March 2021, PYREXIA (fever for 12 hours after second Moderna Covid-19 vaccine) and MYALGIA (sore body aches for 24 hours after second vaccination) had resolved.            It was reported that patient took Acetaminophen.   This case was linked to MOD-2021-386431, MOD-2021-386479 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: excursion from the freezer/administered to 118 patients(25Oct2021- 49 given ); expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) 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 (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) and EXPIRED PRODUCT ADMINISTERED (expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (excursion from the freezer/administered to 118 patients(25Oct2021- 49 given )) 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.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Additional information contain included patient  and suspect details
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; There was an excursion from the freezer/administered to 118 patients; 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 (There was an excursion from the freezer/administered to 118 patients) in an 81-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 (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer/administered to 118 patients). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from the freezer/administered to 118 patients) 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 their freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.  No concomitant medication was provided.  No treatment medication was provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality 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 POOR QUALITY PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients) in a 64-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 POOR QUALITY PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer,vaccine administered to 118 patients) and POOR QUALITY PRODUCT ADMINISTERED (There was an excursion from the freezer,vaccine administered to 118 patients) had resolved.        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
Age: 70.0
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 70-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 (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Nov-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 medication was provided. No treatment information was provided.  Excursion from the freezer occurred on 01-Oct-2021
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Expired product Administered to 118 patients; There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired product Administered to 118 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 70-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 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product Administered to 118 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired product Administered to 118 patients) and 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 stated 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.  No concomitant medications were reported.  No treatment information was reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Administered to 118 patients; There was no excursion from freezer; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered to 118 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was no excursion from 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 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 (Administered to 118 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was no excursion from freezer). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered to 118 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was no 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 stated 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.  No concomitant medications were reported.  No treatment information was reported.
Age: 89.0
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 and EXPIRED PRODUCT ADMINISTERED 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 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 and EXPIRED PRODUCT ADMINISTERED. On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE and EXPIRED PRODUCT ADMINISTERED had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This is a spontaneous case of product temperature excursion issue and expired product administered for this 89-year-old, male patient with no relevant medical history. No adverse event was reported after administration of the third dose of the Moderna mRNA-1273. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Further information has been requested.  No concomitant medication was provided by the reporter.  No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; expired product administered; 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 product administered) in a 77-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 product administered). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (expired product administered) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant drugs reported. There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She stated that her team already knows the recommended temperatures and wanted to know if the vials were still okay to be used because they were administered to 118 patients. Concomitant medications were not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-383410 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-383410:MASTER FILE
Age: 72.0
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 72-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 (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. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was an excursion from their freezer on 01-Oct-2021.   They used the excursion tool but there was no option for the excursion they experienced.   The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis.   She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.  No concomitant medication was provided.  No treatment medication was provided.
Age: 86.0
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 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 the freezer). On 01-Nov-2021, 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 reported. No Treatment medications were reported. There was an excursion from their freezer on 01-Oct-2021
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; expired product administered; 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 product administered) in a 53-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 (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (expired product administered). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and EXPIRED PRODUCT ADMINISTERED (expired product administered) 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 their freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She stated that her team already knows the recommended temperatures and wanted to know if the vials were still okay to be used because they were administered to 118 patients. Concomitant medications were not provided. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-383410 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-383410:MASTER FILE
Age: 74.0
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 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excrusion from freezer). On 01-Nov-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.   There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there is no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.  No concomitant medication was provided.  No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot in her leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in her leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot in her leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot in her leg) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient had a blood clot in her leg.  Company Comment: This case concerns a  female of unknown age  with  no reported medical history , who experienced Non-serious , unexpected event of thrombosis which occurred on an unknown date with an unknown dose of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) . The re-challenge is unknown since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine ( Mdoerna Covid 19 vaccine ) is not affected by this report. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Follow up received on 10-NOV-2021 contains no new information.; Sender's Comments: This case concerns a  female of unknown age  with  no reported medical history , who experienced Non-serious , unexpected event of thrombosis which occurred on an unknown date with an unknown dose of mRNA-1273 vaccine (Moderna Covid 19 vaccine ) . The re-challenge is unknown since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 vaccine ( Mdoerna Covid 19 vaccine ) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Vasovagal Syncope 20 hours after Moderna's second dose; This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (Vasovagal Syncope 20 hours after Moderna's second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SYNCOPE (Vasovagal Syncope 20 hours after Moderna's second dose). At the time of the report, SYNCOPE (Vasovagal Syncope 20 hours after Moderna's second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.Treatment product was not provided by the reporter  Physician was  like to ask some questions about the vaccine before receiving the booster dose. HCP was scheduled to receive booster dose tomorrow  Cortisone shot (40 mg) was received on a week ago in her shoulder.  Company's comment: This case concerns a female subject of unknown age, with no relevant medical history, who experienced the unexpected event of Syncope, diagnosed as "vasovagal syncope" by the reporter(physician). The event occurred 20 hours after the second dose of mRNA 1273 VACCINE. Rechallenge is unknown as only information regarding adverse event after the second dose is available. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report. Event Syncope was upgraded as serious as per IME list; however, based on information available and, as per medical judgement, it is assessed as non-serious, similar to reporter's assessment.; Sender's Comments: This case concerns a female subject of unknown age, with no relevant medical history, who experienced the unexpected event of Syncope, diagnosed as "vasovagal syncope" by the reporter(physician). The event occurred 20 hours after the second dose of mRNA 1273 VACCINE. Rechallenge is unknown as only information regarding adverse event after the second dose is available. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report. Event Syncope was upgraded as serious as per IME list; however, based on information available and, as per medical judgement, it is assessed as non-serious, similar to reporter's assessment.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: red non raised rash face, neck, bilateral forearms, hands; red non raised rash face, neck, bilateral forearms, hands; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 56-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8732, Expiration date: unknown) intramuscular, administered in left arm on 22Apr2021 (age at vaccination was 56 years) as dose 1, single for COVID-19 immunization. The patient's medical history included factor 5 liedham and minimal change nephrotic syndrome as a kid. The patient did not have any known allergies. The patient did not receive any concomitant medications or other medications in two weeks of vaccination. The facility where the most recent COVID-19 vaccine was administered was Other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient had reaction to Pfizer COVID-19 injection. On 22Apr2021, within 2 hours, the patient experienced red non-raised rash face, neck, bilateral forearms, hands. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0153, Expiration date: unknown) intramuscular, administered in left arm on 18May2021 at 17:30 pm (age at vaccination was 56 years) as dose 2, single for COVID-19 immunization. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever of 103.5 - 104 for 5 days .; Chills/Body aches; Chills/Body aches; This is a spontaneous report from a contactable consumer (parent) received via physician. A 15-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 14:00 (at the age of 15-Years-old) (Lot Number: EW0168) as dose 1, single for covid-19 immunisation. The patient's medical history included ADHD (attention deficit hyperactivity disorder) and asthma. Concomitant medication included oral dexmethylphenidate hydrochloride (FOCALIN XR ER) 15 mg daily taken for ADHD from an unspecified start date and ongoing for years. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccine in 4 weeks. The patient did not have COVID prior vaccination. Patient was tested for COVID post vaccination. No known allergies were reported. No known family history illness. On 14May2021, the patient experienced fever of 103.5 - 104 for 5 days started at 23:00. It go down to 101 with Tylenol or ibuprofen. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. On an unknown date in may2021, 24 hours after vaccination, the patient experienced chills/body aches. The patient was seen in the office 18May2021 and Felt to be either viral illness or immune response to vaccine. The patient underwent lab tests and procedures which included body temperature and showed result of 101 on an unknown date, body temperature was 103.5 -104 on 14May2021 and sars-cov-2 test (nasal swab) was negative on 19May2021. Therapeutic measures were taken as a result of fever of 103.5 -104 for 5 days. Therapeutic measures were not taken with to chills/body ache. At the time of this report the outcome of event fever of 103.5-104 for 5 days was recovered on 19May2021 and other events recovered on an unknown date in 2021.  The Physician considered the Pfizer product had a causal effect to the adverse event.   Follow-up attempts are completed. No further information is expected
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath/ Difficulty breathing; This is a spontaneous report from a contactable consumer(patient). A 19-years-old female patient received bnt162b2 (PFIZER -BIONTECH COVID-19 VACCINE, Formulation: Batch/Lot Number: FA7484), via an unspecified route of administration, administered in Arm Left on 26Jul2021 as DOSE 1, SINGLE for covid-19 immunization (age at vaccination 19-years-old). The patient's medical history included asthma. The patient's concomitant medications was not reported. On an unspecified date patient stated that she had been experiencing like shortness of breath and difficulty breathing. The outcome of the event was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Glycosylated haemoglobin, Lymph node pain, Lymphadenopathy, Neck pain
Clinical narrative: throat being slightly swollen; lymph node is swollen like it hurts; lymph node is swollen like it hurts; her jaw and ear hurting; her jaw and ear hurting; her throat hurting; neck hurting; This is a spontaneous report from a contactable consumer or other non hcp. A 45-year-old female patient received bnt162b2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: FA6780), via an unspecified route of administration, administered in Arm Left on 23Jul2021 at 12:00) (at the age of 45-year-old) as Dose 1, Single for covid-19 immunization. The patient medical history included diabetes mellitus from an unknown date and unknown if ongoing and to help the kidneys (Kidney disorder). Concomitant medications included metformin hydrochloride, sitagliptin phosphate monohydrate and insulin glargine taken for diabetes mellitus from an unspecified start date and ongoing, liraglutide, lisinopril (to help the kidneys) and rosuvastatin calcium taken for an unspecified indication from an unspecified start date and ongoing, omeprazole taken for dyspepsia from an unspecified start date and ongoing, lurasidone hydrochloride taken for depression from an unspecified start date and ongoing and clonazepam taken for anxiety from an unspecified start date and ongoing. On 24Jul2021 (the next day after vaccination), the patient started to have complaints of her throat hurting, neck hurting. On 25Jul2021, she had complaints on her jaw and ear hurting. On 29Jul2021, the patient had complaints in her throat being slightly swollen and jaw pain. The patient also experienced jaw and ear hurting, throat being slightly swollen, lymph node is swollen like it hurts, lymph node is swollen like it hurts on an unspecified date. The patient underwent lab tests and procedures which included glycosylated haemoglobin: unknown on an unspecified date. After she took it, her throat started hurting and so far, she has had no trouble swallowing but, her neck has been hurting. Sunday night, it went up into her jaw and into her ear. The patient went to the emergency room and waited for 8hours, so she did not stay. She has been trying to get in touch with her doctor all week and call it in. Was trying for a same day appointment but has not been able to get it. Therapeutic measures were taken as a result of her throat hurting, her jaw and ear hurting, her jaw and ear hurting, throat being slightly swollen, lymph node is swollen, like it hurts, lymph node is swollen like it hurts and neck hurting. The clinical outcome of all the events were not recovered.  No follow-up attempts are possible, no further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pain in jaw, Pharyngeal swelling
Clinical narrative: throat being slightly swollen; lymph node is swollen like it hurts; lymph node is swollen like it hurts; her jaw and ear hurting; her jaw and ear hurting; her throat hurting; neck hurting; This is a spontaneous report from a contactable consumer or other non hcp. A 45-year-old female patient received bnt162b2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: FA6780), via an unspecified route of administration, administered in Arm Left on 23Jul2021 at 12:00) (at the age of 45-year-old) as Dose 1, Single for covid-19 immunization. The patient medical history included diabetes mellitus from an unknown date and unknown if ongoing and to help the kidneys (Kidney disorder). Concomitant medications included metformin hydrochloride, sitagliptin phosphate monohydrate and insulin glargine taken for diabetes mellitus from an unspecified start date and ongoing, liraglutide, lisinopril (to help the kidneys) and rosuvastatin calcium taken for an unspecified indication from an unspecified start date and ongoing, omeprazole taken for dyspepsia from an unspecified start date and ongoing, lurasidone hydrochloride taken for depression from an unspecified start date and ongoing and clonazepam taken for anxiety from an unspecified start date and ongoing. On 24Jul2021 (the next day after vaccination), the patient started to have complaints of her throat hurting, neck hurting. On 25Jul2021, she had complaints on her jaw and ear hurting. On 29Jul2021, the patient had complaints in her throat being slightly swollen and jaw pain. The patient also experienced jaw and ear hurting, throat being slightly swollen, lymph node is swollen like it hurts, lymph node is swollen like it hurts on an unspecified date. The patient underwent lab tests and procedures which included glycosylated haemoglobin: unknown on an unspecified date. After she took it, her throat started hurting and so far, she has had no trouble swallowing but, her neck has been hurting. Sunday night, it went up into her jaw and into her ear. The patient went to the emergency room and waited for 8hours, so she did not stay. She has been trying to get in touch with her doctor all week and call it in. Was trying for a same day appointment but has not been able to get it. Therapeutic measures were taken as a result of her throat hurting, her jaw and ear hurting, her jaw and ear hurting, throat being slightly swollen, lymph node is swollen, like it hurts, lymph node is swollen like it hurts and neck hurting. The clinical outcome of all the events were not recovered.  No follow-up attempts are possible, no further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder, Ear inflammation, Ear pruritus, Ear swelling, Erythema
Clinical narrative: my external ears began mild but consistent itching;; my external ears began mild but consistent itching; they looked inflamed; Then I began needing to rub them more and more because kept being itchy and they were swollen; Then I began needing to rub them more and more because kept being itchy and they were swollen and no fever but red and hardened; i have a pic when it swoll up and inflamed and a pic after ears returned to normal and stopped bring itchy and irritated; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0181, Expiry Date: not reported) via an unspecified route of administration, administered in arm left on 08Jul2021 at 03:15 (at the age of 68 years old) as DOSE 2, SINGLE for COVID-19 immunization at pharmacy or drug store. Medical history included bit overweight 175 lbs and allergies to codeine and percoset (bothers me) from an unknown date and unknown if ongoing. There were no concomitant medications reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0181, Expiry Date: not reported) via an unspecified route of administration, administered in arm left on 17Jun2021 at 03:30 (at the age of 68 years old) as DOSE 1, SINGLE for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. The patient received within 2 weeks of vaccination was none. The patient got vaccine on thursday 8Jul2021. On sunday (11Jul2021 at 15:45) afternoon 1 then both of her external ears began mild but consistent itching and she thought maybe a mosquito bite but both kept irritating her, so she got a cool cloth after she saw they looked inflamed. Then it began needing to rub them more and more because kept being itchy and they were swollen and no fever but red and hardened, they continued to be itchy and irritated got 2 days from sunday afternoon july 11 to late afternoon july 13th. She ate no new foods, had no alcohol or new drinks used no new soaps or shampoos nothing. She do have pictures of her ear. Both ears were red she took pic of 1 ear as it was same on both ears, she had a pic when it swoll up and inflamed and a pic after ears. The patient did not receive any treatment for the events. The reporter assessed the events as non-serious. The events were recovered on 13Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Seasonal allergy
Clinical narrative: Cold; like hay fever type stuff; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0182), via an unspecified route of administration, administered in arm right on 18Aug2021 (at the age of 55-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Sep2021, the patient experienced cold and on an unknown date in 2021, the patient experienced hay fever type stuff. Caller reported that he doesn't think the cold is related to getting the vaccine, he thinks it was being in a lot of yards, like hay fever type stuff, it only lasted about 24 hours or a couple days, the effects from the weekend over the last couple of days. Caller says he treated the cold with Alka-Seltzer Cold Plus, and he is feeling better, though he is not 100%, since there is still a little bit, it is not all the way gone, but he felt good enough that he went to work today. Therapeutic measures were taken as a result of the event (cold) which included treatment with Alka-Seltzer Cold Plus. The patient received second dose on 08Sep2021. The outcome of the event cold was recovering and event like hay fever type stuff was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Influenza like illness, Insomnia, Musculoskeletal discomfort, Nasopharyngitis
Clinical narrative: Discomfort in throat, chest, and back; Discomfort in throat, chest, and back; Discomfort in throat, chest, and back; Similar to cold or flu; Similar to cold or flu; Rash; sleeplessness; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FC3182), via an unspecified route of administration, administered in Arm Right on 14Sep2021 at 18:30 (age at vaccination: 51 year) as dose 1, single for covid-19 immunization. Medical history included Asthma, elevated blood pressure, from an unknown date and unknown if ongoing and Known allergies reported as Yes - medications with sulfa. Concomitant medications included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported, salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) taken for an unspecified indication, start and stop date were not reported, fluticasone propionate (FLOVENT) taken for an unspecified indication, start and stop date were not reported. Other medications in two weeks reported as Albuterol, Flovent, amlodipine, vitamins. If other vaccine in four weeks reported as no. Covid prior vaccination reported as no and covid tested post vaccination reported as no. On 14Sep2021 at 19:00 the patient experienced Discomfort in throat, chest, and back similar to cold or flu, rash, sleeplessness. Therapeutic measures were taken as a result of AE. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Rash
Clinical narrative: Discomfort in throat, chest, and back; Discomfort in throat, chest, and back; Discomfort in throat, chest, and back; Similar to cold or flu; Similar to cold or flu; Rash; sleeplessness; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional.  A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FC3182), via an unspecified route of administration, administered in Arm Right on 14Sep2021 at 18:30 (age at vaccination: 51 year) as dose 1, single for covid-19 immunization. Medical history included Asthma, elevated blood pressure, from an unknown date and unknown if ongoing and Known allergies reported as Yes - medications with sulfa. Concomitant medications included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported, salbutamol sulfate (ALBUTEROL [SALBUTAMOL SULFATE]) taken for an unspecified indication, start and stop date were not reported, fluticasone propionate (FLOVENT) taken for an unspecified indication, start and stop date were not reported. Other medications in two weeks reported as Albuterol, Flovent, amlodipine, vitamins. If other vaccine in four weeks reported as no. Covid prior vaccination reported as no and covid tested post vaccination reported as no. On 14Sep2021 at 19:00 the patient experienced Discomfort in throat, chest, and back similar to cold or flu, rash, sleeplessness. Therapeutic measures were taken as a result of AE. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.