chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Number of doses administered was 102 doses. The vial did not undergo any temperature excursions. No treatment information reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live FU received with non significant information
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/administer expired vaccine to patients, after the manufacture date of expiration) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses.  The vial did not undergo any temperature excursions.  No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains, additional reporter was added.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by a physical therapist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vial did not undergo any temperature excursions.  No treatment medication was reported by reporter.   This case was linked to MOD-2022-581986 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up was received and included no significant information
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patients/ Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided  The vial did not undergo any temperature excursions Total of 168 doses were given  from LOT 048C21A It was reported that the date vial initially stored in refrigerator was unknown  Treatment medication was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant follow up was received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that vials had not undergone any temperature excursion. Total of 168 doses/vials were given for LOT 048C21A. It was unknown when the vial was stored in refrigerator.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient, after the manufacture date of expiration 09-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.  Dates of administration of vaccine were reported as 10-Nov-2021 and 11-Nov-2021.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non-significant information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/  expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/  expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in an 80-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/  expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/  expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Reportedly, 173 doses or vials were initially stored in the refrigerator on an unknown date.  The vial did not undergo any temperature excursions.  Treatment details were not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up document contains no additional information.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 66-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022 / expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.   The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/administerd expired vaccine to patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/administerd expired vaccine to patients, after the manufacture date of expiration.) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/administerd expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and administered on 10-Nov-2021/administerd expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 168 doses.  The vial did not undergo any temperature excursions.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2022: Follow up document received, additional reporter was added.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Total of 168 doses/vials were given for LOT  048C21A.  The vial did not undergone to any temperature excursions. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contains non significant information
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered vaccine after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration.) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.  It was reported that vials had not undergone any temperature excursion.Total of 168 doses/vials were given for LOT  048C21A.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up contains  Non Significant information.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used/ administer expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ administer expired vaccine to 450 patients, after the manufacture date of expiration.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ administer expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used/ administer expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was unknown if the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received included non-significant information.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administer expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patient after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 24-Oct-2021. The vial did not undergo any temperature excursions.  No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter address updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 24-Oct-2021 and was administered to patient on 25-Oct-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and was administered to patient on 25-Oct-2021) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and was administered to patient on 25-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and was administered to patient on 25-Oct-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 24-Oct-2021. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter address updated.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 09-Nov-2021. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter address updated.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 09-Nov-2021 and was administered to the patient on 10-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and was administered to the patient on 10-Nov-2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and was administered to the patient on 10-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 09-Nov-2021 and was administered to the patient on 10-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 09-Nov-2021. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter address updated.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high. This spontaneous case was reported by a patient and describes the occurrence of BLOOD GLUCOSE INCREASED (After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 prophylaxis.     Patient reported she had some other allergies too (Extensive list that is too long to report). The patient did not had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (She always gets the flu shot every year and and she never has a problem). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Diabetes (But her A1C is mostly under 7percent. She did not have to take diabetes medicine.), Drug allergy (Phenobarbital), Drug allergy (Dilantin), Allergy to antibiotic, Food allergy (Chamomile tea), Ragweed allergy and Blood pressure high.    On 14-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced BLOOD GLUCOSE INCREASED (After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high.). At the time of the report, BLOOD GLUCOSE INCREASED (After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, Blood glucose: high She got her labs done. Her sugar was high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided by reporter. Treatment information was not provided.   This case was linked to MOD-2022-586371 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood glucose, Dry mouth, Feeling abnormal, Lethargy
Clinical narrative: After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high. This spontaneous case was reported by a patient and describes the occurrence of BLOOD GLUCOSE INCREASED (After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 prophylaxis.     Patient reported she had some other allergies too (Extensive list that is too long to report). The patient did not had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (She always gets the flu shot every year and and she never has a problem). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Diabetes (But her A1C is mostly under 7percent. She did not have to take diabetes medicine.), Drug allergy (Phenobarbital), Drug allergy (Dilantin), Allergy to antibiotic, Food allergy (Chamomile tea), Ragweed allergy and Blood pressure high.    On 14-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced BLOOD GLUCOSE INCREASED (After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high.). At the time of the report, BLOOD GLUCOSE INCREASED (After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, Blood glucose: high She got her labs done. Her sugar was high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided by reporter. Treatment information was not provided.   This case was linked to MOD-2022-586371 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thirst
Clinical narrative: After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high. This spontaneous case was reported by a patient and describes the occurrence of BLOOD GLUCOSE INCREASED (After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 prophylaxis.     Patient reported she had some other allergies too (Extensive list that is too long to report). The patient did not had COVID positive test or diagnosis.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE (She always gets the flu shot every year and and she never has a problem). Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Diabetes (But her A1C is mostly under 7percent. She did not have to take diabetes medicine.), Drug allergy (Phenobarbital), Drug allergy (Dilantin), Allergy to antibiotic, Food allergy (Chamomile tea), Ragweed allergy and Blood pressure high.    On 14-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, the patient experienced BLOOD GLUCOSE INCREASED (After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high.). At the time of the report, BLOOD GLUCOSE INCREASED (After she got vaccinated two days after that 14 Dec 2021, she got her labs done. Her sugar was high.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Dec-2021, Blood glucose: high She got her labs done. Her sugar was high.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided by reporter. Treatment information was not provided.   This case was linked to MOD-2022-586371 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Illness, Malaise, Pyrexia
Clinical narrative: No energy; Nothing hurts, just doesn't feel well; patient feels sick; Fever since Sunday afternoon; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (No energy), MALAISE (Nothing hurts, just doesn't feel well), ILLNESS (patient feels sick) and PYREXIA (Fever since Sunday afternoon) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     Patient had never COVID positive test or diagnosed with it.  No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. .  Previously administered products included for Product used for unknown indication: Pfizer (1st dose, Batch number- EP7534) on 23-Mar-2021, Pfizer (2nd dose) on 13-Apr-2021 and Pfizer (1st booster) on 19-Oct-2021. Past adverse reactions to the above products included Adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Drug allergy (Medication allergies but patient didn't want to specify). On 04-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2022, the patient experienced PYREXIA (Fever since Sunday afternoon). On an unknown date, the patient experienced ASTHENIA (No energy), MALAISE (Nothing hurts, just doesn't feel well) and ILLNESS (patient feels sick). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (No energy), MALAISE (Nothing hurts, just doesn't feel well), ILLNESS (patient feels sick) and PYREXIA (Fever since Sunday afternoon) had not resolved. Concomitant medication was not reported. It was 5 days since the second booster shot and was having symptoms. Patient went for office visit to seek medical care for the adverse event. The patient had experienced a similar event in the past but not for long, patient has gotten similar side effects with other COVID vaccines but never lasted long, it already been 5 days.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), in Oct2021 as dose 3 (booster) single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: 7 days after completing treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Previously patient received paxlovid the COVID-19 vaccine and Patient exhibiting rebound of symptoms and positive antigen testing 7 days after completing treatment  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Laryngitis, Lymphadenopathy, Oropharyngeal pain, Sinus disorder
Clinical narrative: Armpit pain that lasted about a week. Swollen lymph nodes in armpit lasted about a week before moving up to swollen lymph nodes in neck. Sinus issues including post nasal drip that caused laryngitis and constant sore throat. Post nasal drip and sore throat not going away.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: Armpit pain that lasted about a week. Swollen lymph nodes in armpit lasted about a week before moving up to swollen lymph nodes in neck. Sinus issues including post nasal drip that caused laryngitis and constant sore throat. Post nasal drip and sore throat not going away.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chromaturia, Decreased appetite, Diarrhoea haemorrhagic, Headache
Clinical narrative: 'Crushing' headache, pain going up left side of neck to temple, and left side of chest feeling painful, around heart? area, arm slightly sore and swollen, diarrhea w/bloody & tan colored mucus, urine very 'rust' colored, area above ankles initially felt constructed but lasted only that day, started taking acetaminophen when reached home after shot, took 1, then 11 hrs later another, then 11 hrs later, another. Feeling better, but crushing headache still present. Haven't eaten since shot and perusing diarrhea. Hadn't eaten that day.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Mucosal discolouration, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: 'Crushing' headache, pain going up left side of neck to temple, and left side of chest feeling painful, around heart? area, arm slightly sore and swollen, diarrhea w/bloody & tan colored mucus, urine very 'rust' colored, area above ankles initially felt constructed but lasted only that day, started taking acetaminophen when reached home after shot, took 1, then 11 hrs later another, then 11 hrs later, another. Feeling better, but crushing headache still present. Haven't eaten since shot and perusing diarrhea. Hadn't eaten that day.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer  expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer  expired vaccine to 450 patients, after the manufacture date of expiration.) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer  expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer  expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported number of doses /vials given as 168 on 10-Nov-2021 and 11-Nov-2022.  No information was reported on the storage of vaccine in refrigerator.  The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2022: Significant follow-up received: Patient demographics (initials, DOB, age) were added. On 08-Jun-2022: Live Follow-up received: Additional reporter added.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Immunosuppressant drug therapy, Pain, Rheumatoid arthritis
Clinical narrative: have R A and am on imusupresent meds; 4th case of shingles; shingles are very painful.; This case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a 85-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant), shingles and pain. The patient was treated with immunosuppressants nos (Immunosuppressant Drug (Nos)). On an unknown date, the outcome of the rheumatoid arthritis and shingles were not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the rheumatoid arthritis, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 06-JUN-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient currently had 4th case of shingles.  The patient had 1st shingles shot but delayed second because he/she had rheumatoid arthritis and was on immunosuppressant medicine.  The patient requested, if you were able please take shots, as shingles were very painful. Additional Supportive Information: Follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery dissection, Heart rate, Immunisation reaction, Magnetic resonance imaging
Clinical narrative: SPONTANEOUS CORONARY ARTERY DISSECTION; SEVERE ADVERSE REACTION TO JANSSEN COVID-19; This spontaneous report received from a patient concerned a 66 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. Apart from her age, the patient was otherwise healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 01 total administered on OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-OCT-2021, the patient experienced severe adverse reaction to Janssen COVID-19. Eight hours after, the patient had increased heart rate (HR) of 130-150 bpm; and 911 was called and the patient was taken to hospital and got admitted. Magnetic resonance imaging (MRI) showed Septal myocardial infarction (MI). The patient was diagnosed with spontaneous coronary artery dissection. The patient was hospitalized for two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spontaneous coronary artery dissection and severe adverse reaction to janssen covid-19 was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220609922-Covid-19 vaccine ad26.cov2.s-spontaneous coronary artery dissection, severe adverse reaction to Janssen covid-19. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that, the dose administered after 30-day Use By Date or after manufacturer date of expiry. 102 doses administered. On unknown date the vial was stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2022: Follow-up received contain significant information include Patient demographics, Suspect product dosage information and narrative updated. On 08-Jun-2022: Live follow-up received contain non significant information include reporter's details updated.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 24-Oct-2021 and administered on 25-Oct-2021/Expired vaccine was administered after the 30-day Use by Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reportedly, 102 doses or vials were initially stored in the refrigerator on an unknown date. It was reported that vials had not undergone any temperature excursion. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live FU was received with reporter address updated.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Date the vial was initially stored in the refrigerator reported as unknown and the vial did not undergo any temperature excursions. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Non Significant follow up appended