chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Cold-like symptoms, positive COVID test (rapid test and PCR test); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Cold-like symptoms, positive COVID test (rapid test and PCR test)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient Relevant medical history and concurrent condition reported as none.  Concurrent medical conditions included Allergy (Unspecified drug).    On 09-May-2022 at 12:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2022 at 9:00 AM, the patient experienced COVID-19 (Cold-like symptoms, positive COVID test (rapid test and PCR test)). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 19-May-2022 to 24-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Cold-like symptoms, positive COVID test (rapid test and PCR test)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2022, SARS-CoV-2 test: positive (Positive) time: 09:00 Positive and positive (Positive) time: 09:00 Positive.         It was unknown if the patient was taking any other medications or products within two weeks of starting COVID-19 treatment with Paxlovid. Company comment: This spontaneous case concerns a patient of unspecified age and gender,with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Cold-like symptoms, positive COVID test (rapid test and PCR test)) which occurred 20 days after the fourth dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. SARS-CoV-2 test was positive as on 29-May-2022.Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender,with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Cold-like symptoms, positive COVID test (rapid test and PCR test)) which occurred 20 days after the fourth dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. SARS-CoV-2 test was positive as on 29-May-2022.Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to antibiotics (Azythromycin). Concomitant products included SPIRONOLACTONE for an unknown indication.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            The patient took COVID-19 Treatment with unknown product from 15-May-2022 to 19-May-2022. On 27-May-2022, the patient had body aches, fatigue, runny nose, congestion, sore throat, sinus pain and pressure. Device date :01-Jun-2022.  Company comment: This spontaneous case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received an unspecified drug as treatment for COVID 19 from 16-May to 19-May. Approximately 8 days later the patient had body aches, fatigue, runny nose, congestion, sore throat, sinus pain and pressure. Details regarding event outcome, investigations and further treatment are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected non serious AESI of COVID 19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID 19 vaccination series. Patient received an unspecified drug as treatment for COVID 19 from 16-May to 19-May. Approximately 8 days later the patient had body aches, fatigue, runny nose, congestion, sore throat, sinus pain and pressure. Details regarding event outcome, investigations and further treatment are not available. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain, Vaccination site swelling
Clinical narrative: Unable to move right arm; a lot of swelling at injection site; A lot of pain; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to move right arm), VACCINATION SITE SWELLING (a lot of swelling at injection site) and VACCINATION SITE PAIN (A lot of pain) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, BUSPIRONE HYDROCHLORIDE (BUSPAR), SITAGLIPTIN PHOSPHATE (JANUVIA), LOVASTATIN, LOSARTAN and HYDROCHLOROTHIAZIDE (HCTZ) for an unknown indication.   On 28-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to move right arm), VACCINATION SITE SWELLING (a lot of swelling at injection site) and VACCINATION SITE PAIN (A lot of pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to move right arm), VACCINATION SITE SWELLING (a lot of swelling at injection site) and VACCINATION SITE PAIN (A lot of pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had been alternating heat and ice, and also taking Tylenol and Zyrtec for treatment. Caller says none of those have helped.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 27-Apr-2022); Expired vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 27-Apr-2022)) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 27-Apr-2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) and PRODUCT STORAGE ERROR (Expired vaccine was kept it in the fridge (CDC expiration date was 03-Apr-2022 and vaccine was removed from the fridge on 27-Apr-2022)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The vaccine provider removed the vaccine from the fridge, thawed it if needed and administered it on the same day of removal. The expired vaccine was kept it in the fridge and only removed to administer the patients.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-569375 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patient administered vaccine past the expiration date on 09-May-2022, expiration date: 03-Apr-2022; Patient administered vaccine past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Patient administered vaccine past the expiration date on 09-May-2022, expiration date: 03-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine past the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient administered vaccine past the expiration date on 09-May-2022, expiration date: 03-Apr-2022). At the time of the report, PRODUCT STORAGE ERROR (Patient administered vaccine past the expiration date on 09-May-2022, expiration date: 03-Apr-2022) and EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine past the expiration date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The provider removed the vaccine from the fridge thawed whether needed, and administered the same day of removal.   A total 15 doses were administered.  The date of the vial removed from the fridge was 09-May-2022.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2022: Follow-up document received includes significant information; lot number of suspect vaccine was updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was exposed to refrigerator temperature for more than 24 hours after first puncture.; Administered expired vaccine beyond 12 hours after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine beyond 12 hours after first puncture) and PRODUCT STORAGE ERROR (The vial was exposed to refrigerator temperature for more than 24 hours after first puncture.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine beyond 12 hours after first puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was exposed to refrigerator temperature for more than 24 hours after first puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine beyond 12 hours after first puncture) and PRODUCT STORAGE ERROR (The vial was exposed to refrigerator temperature for more than 24 hours after first puncture.) 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: Unknown but liquid unpunctured vial came in a cooler from another facility with beyond use date of 24MAY2022. Date and time vial was first punctured: Vial punctured on 20-May-2022 at 5PM. The vial was stored in refrigerator post puncture. The vial did not undergone any temperature excursion.  No treatment medications was reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vials were stored in the refrigerator and thawed on same day of administration; Vaccine was expired on 04-Apr-2022 and was administered on 06-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and was administered on 06-Apr-2022) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and was administered on 06-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and was administered on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's weight was reported as 109.  Concomitant medications were not reported.  The patient had received booster 1. The patient had no known reactions. The vials were thawed on same day of administration. The vials did not undergo any temperature excursions.  Treatment information was not reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose was administered beyonf 30 days of use; Doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (Dose was administered beyonf 30 days of use) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose was administered beyonf 30 days of use). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (Dose was administered beyonf 30 days of use) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was administered with booster 2. No concomitant medications information was reported.  HCP stated they administered expired doses of the Moderna COVID-19 Vaccine to 27 patients. Number of doses/vials: 27 doses Vials were thawed on the same day of administration Date(s) of administration of vaccine- since 06-Apr-2022 until 25-May-2022 The vial did not undergo any temperature excursions. There were no known reactions in office.  No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine beyond the 30 day refrigerator shelf life; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. It was reported that 6 patients received expired Moderna COVID-19 vaccine beyond the 30 day refrigerator shelf life, from 5 MAY 2022 through 23 MAY 2022.  No treatment information was provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration; The vial was expired on 04-Apr-2022 and administered on 07-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 07-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 07-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 07-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The weight of patient was reported as 192.  Patient received second booster. Date the vial was initially stored in the refrigerator, was the same day vials were thawed. The vial did not undergo any temperature excursions. It was reported that patient did not experienced any known reactions.  No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 30 Mar 2022 date of administration of vaccine was on 18 May 2022; Received expired vaccine beyond the 30 day refrigerator shelf life; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30 Mar 2022 date of administration of vaccine was on 18 May 2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30 Mar 2022 date of administration of vaccine was on 18 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine beyond the 30 day refrigerator shelf life) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 30 Mar 2022 date of administration of vaccine was on 18 May 2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not reported.  It was reported that the vials were initially stored in refrigerator on 30-Mar-2021 and was administered to 6 patient on 18-May-2022. The vial did not undergo any temperature excursion.  Treatment medications were not reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vials were stored in the refrigerator and thawed on same day of administration; Doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's weight was reported as 254. The patient had received booster one dose. No concomitant medications were reported. It was reported that the Vials was thawed on the same day of vaccine administration date. It was reported that vial did not undergo any temperature excursion. It was reported that patient had no known reaction in the office after receiving the dose. No treatment medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial expired on 04-Apr-2022, vial thawed on 26-Apr-2022 and administered on 26-Apr-2022; Doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (Vial expired on 04-Apr-2022, vial thawed on 26-Apr-2022 and administered on 26-Apr-2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 04-Apr-2022, vial thawed on 26-Apr-2022 and administered on 26-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) and PRODUCT STORAGE ERROR (Vial expired on 04-Apr-2022, vial thawed on 26-Apr-2022 and administered on 26-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's weight was reported as 233. The patient received booster 1 on 26-Apr-2022. Concomitant medication list was not provided. The vial was initially stored in the refrigerator: vials thawed on the same day of administration, 26-Apr-2022. Number of doses/vials- 27 doses.The vial did not undergo any temperature excursions. No known adverse reactions in office. Treatment information was unknown.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial first expired then stored in refrigerator on same date of administration; doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date) and PRODUCT STORAGE ERROR (vial first expired then stored in refrigerator on same date of administration) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial first expired then stored in refrigerator on same date of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date) and PRODUCT STORAGE ERROR (vial first expired then stored in refrigerator on same date of administration) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The patient had received booster 1. The patient had no known reactions. The vial did not undergo any temperature excursions. It was stated that the vial was thawed on the same day of administration. Treatment medications were not provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vials were stored in the refrigerator and thawed on same day of administration; Vaccine was administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the expiration date) and PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered after the expiration date) and PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 169.  Concomitant medications were not reported.  The patient had received booster 1. The patient had no known reactions. The vials were thawed on same day of administration. The vials did not undergo any temperature excursions.  Treatment information was not reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration; The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 25-Apr-2022 and 25-May-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Patient had no known reactions at office. The vial was thawed same day of administration. The vials did not undergo any temperature excursions.  No adverse events were reported.  No treatment medications were provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vials were stored in the refrigerator and thawed on same day of administration; Doses were administered after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Doses were administered after the expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's weight was reported as 200.  Concomitant medications were not reported.  The patient had received booster 1. The patient had no known reactions. The vials were thawed on same day of administration. The vials did not undergo any temperature excursions.  Treatment information was not reported.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 04-Apr-2022 and stored in the refrigerator on same day of administration; Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and stored in the refrigerator on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and stored in the refrigerator on same day of administration). At the time of the report, PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and stored in the refrigerator on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 13-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's weight was reported as 136. No concomitant medication information was provided.  HCP stated they administered expired doses of the Moderna COVID-19 Vaccine to 27 patients. It was reported that the vials were thawed on the same day of administration. The vails had not undergone ay temperature excursion. It was also reported that patient had no known reactions in office. No treatment medication information was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Vial was not initially stored in the refrigerator. Vial did not undergo any temperature excursions. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 04-Apr-2022 and administered on 22-APR-2022; Vaccine was expired on 04-Apr-2022 and administered on 22-APR-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 22-APR-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 04-Apr-2022 and administered on 22-APR-2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 22-APR-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 04-Apr-2022 and administered on 22-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 04-Apr-2022 and administered on 22-APR-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 04-Apr-2022 and administered on 22-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's weight was reported as 120 with unknown units. No concomitant medications were reported by the reporter.  It was reported that patient was administered with booster 1 dose.  It was reported that they were unsure if doses were administered after the expiration date. Number of doses/vials were 27 doses. Vials thawed on the same day of administration. Date(s) of administration of vaccine was since 06-Apr-2022 until 25-May-2022 Vial did not undergo any temperature excursions. No known reactions were reported in office.  No treatment medications were reported by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vials were stored in the refrigerator and thawed on same day of administration; Vacccine was expired on 04-Apr-2022 and was administered on 20-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Vacccine was expired on 04-Apr-2022 and was administered on 20-May-2022) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vacccine was expired on 04-Apr-2022 and was administered on 20-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration). At the time of the report, PRODUCT STORAGE ERROR (vials were stored in the refrigerator and thawed on same day of administration) and EXPIRED PRODUCT ADMINISTERED (Vacccine was expired on 04-Apr-2022 and was administered on 20-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient weight was reported as 180. Patient received Booster 2. No concomitant medications were reported. It was reported that the Vials was thawed on the same day of vaccine administration date. Vials did not  undergo any temperature excursions. No treatment information were reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine expired on 04-Apr-2022 and administered on 25-May-2022.; doses were administered after the expiration date/Administered after 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date/Administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and administered on 25-May-2022.) in a 38-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date/Administered after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and administered on 25-May-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered after the expiration date/Administered after 30-day use by date) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and administered on 25-May-2022.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that vaccine their office administered were expired at the time of administration.  The vials were thawed on same day of administration and the vial did not undergo any temperature excursions.  The patient had no known reactions at office. The patient's weight was reported as 230 with unknown units.  No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Illness, Influenza like illness, Pyrexia
Clinical narrative: sick; weak; Almost like the flu, but not that bad; tired; fever; tenderness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Almost like the flu, but not that bad), FATIGUE (tired) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A72B, 939906, 048A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2021. Concurrent medical conditions included Blood pressure high, Thyroid disorder, COPD, Heart disorder, Cholesterol, Reflux esophagitis, Osteoporosis and Lung disorder. Concomitant products included LISINOPRIL for Blood pressure high, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for COPD, EZETIMIBE for Cholesterol, ROSUVASTATIN for Heart disorder, ALBUTEROL [SALBUTAMOL] for Lung disorder, DENOSUMAB (PROLIA) for Osteoporosis, PANTOPRAZOLE for Reflux esophagitis, LEVOTHYROXINE for Thyroid disorder, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022, the patient experienced ILLNESS (sick), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Almost like the flu, but not that bad), FATIGUE (tired), PYREXIA (fever) and VACCINATION SITE PAIN (tenderness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) on 01-Jun-2022 at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Almost like the flu, but not that bad), FATIGUE (tired), PYREXIA (fever) and VACCINATION SITE PAIN (tenderness at the injection site) had not resolved.            This case was linked to MOD-2022-581890, MOD-2022-582635 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sick; weak; Almost like the flu, but not that bad; tired; fever; tenderness at the injection site; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Almost like the flu, but not that bad), FATIGUE (tired) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A72B, 939906, 048A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2021. Concurrent medical conditions included Blood pressure high, Thyroid disorder, COPD, Heart disorder, Cholesterol, Reflux esophagitis, Osteoporosis and Lung disorder. Concomitant products included LISINOPRIL for Blood pressure high, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for COPD, EZETIMIBE for Cholesterol, ROSUVASTATIN for Heart disorder, ALBUTEROL [SALBUTAMOL] for Lung disorder, DENOSUMAB (PROLIA) for Osteoporosis, PANTOPRAZOLE for Reflux esophagitis, LEVOTHYROXINE for Thyroid disorder, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2022, the patient experienced ILLNESS (sick), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Almost like the flu, but not that bad), FATIGUE (tired), PYREXIA (fever) and VACCINATION SITE PAIN (tenderness at the injection site). The patient was treated with PARACETAMOL (TYLENOL) on 01-Jun-2022 at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), ASTHENIA (weak), INFLUENZA LIKE ILLNESS (Almost like the flu, but not that bad), FATIGUE (tired), PYREXIA (fever) and VACCINATION SITE PAIN (tenderness at the injection site) had not resolved.            This case was linked to MOD-2022-581890, MOD-2022-582635 (Patient Link).