chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Patient received a 0.25 ml dose as booster from booster dose only presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 25 microgram. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster from booster dose only presentation vial).    No concomitant medications were reported.  The patient administered with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml instead of 0.5 ml. Vaccination date was reported as between 22-Jul-2022 and 28-Jul-2022.  It was unknown if patient experienced any symptoms after getting the vaccine.  No treatment information was reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient received a volume of 0.25 ml dose instead of 0.5 ml from presentation vial).    No concomitant product use was reported.   Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022. The patient was administered vaccine booster dose with a volume of 0.25 ml (25 mcg) instead of 0.5 ml (50 mcg).  It was unknown if patient experienced any symptoms after getting the vaccine.  Treatment information was not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg)); This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg))) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg))). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg))) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Patient received a 0.25 ml dose as booster dose only presentation vial instead of 0.5 mL (50 mcg))).    No concomitant medications were reported.   Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022.  It was reported that the patient had received 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose.   It was unknown if patient experienced any symptoms after getting the vaccine.  The reporter was told that adult patients who received a 25 mcg dose in the past 24 hours could come and get another 25 mcg dose and be considered as getting a full 50 mcg to start with, but it was reported that the vast majority of patients had received this half dose more than 24 hours ago.  No treatment medications was provided by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose) and NO ADVERSE EVENT (No adverse event) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose).    No concomitant medications information was reported.  Vaccination date: between 22-Jul-2022 and 28-Jul-2022 It was unknown if patient experienced any symptoms after getting the vaccine. Patient administered with a volume of 0.25 ml (25 mcg) drug as booster dose.  No treatment medications were provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; 35 patients received a 0.25 ml dose as booster from booster dose only presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial).    No concomitant product use was reported.   Patient administered booster dose.  Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022.  It was unknown if patient experienced any symptoms after getting the vaccine.  Treatment information was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced ACCIDENTAL UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Administered patient with Moderna COVID-19 Vaccine booster dose only presentation, with a volume of 0.25 ml (25 mcg) instead of 0.5 mL (50 mcg) as a booster dose).    No concomitant medications information was reported.  Vaccination date: between 22-Jul-2022 and 28-Jul-2022. It was unknown if patients experienced any symptoms after getting the vaccine.  No treatment medications were provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; 35 patients received a 0.25 ml dose as booster from booster dose only presentation vial; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In July 2022, the patient experienced INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial). No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. Vaccination dates reported was between 22-Jul-2022 and 28-Jul-2022. The patient was administered vaccine with a volume of 0.25 ml instead of 0.5 ml. Unknown if patient experienced any symptoms after getting the vaccine.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 16Jul2022).    Concomitant medications were not reported.  They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions. Treatment medications were not reported.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022) and NO ADVERSE EVENT (No adverse event) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022).    No concomitant medications were provided by the reporter.  The patient received half dose.  The number of doses/vials administered were 35 vials. Date the vial was initially stored in the refrigerator was 04-Jun-2022. The vaccines were administered from the 04-Jun-2022 until the 26-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medications were provided by the reporter
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022; No adverse event; The patient administered the vaccine after the 30 days by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 07-Jul-2022).    No concomitant product use was reported. The patient received half dose. The vial had not undergone any temperature excursions. No treatment information was provided.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022; No Adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No Adverse event) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022).    No concomitant product use was reported.  Vaccine was stored in refrigerator on 04-Jun-2022.  Patient received half dose.  Vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date; No adverse event; Administered the vaccine after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date).    Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 18-Jul-2022 No concomitant product use was reported. Patient received full dose. On 04-Jun-2022 the vials were initially stored in the refrigerator. Vial did not undergo any temperature excursions. No treatment information was provided.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022) and NO ADVERSE EVENT (No adverse event) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 14Jul2022).    Concomitant medications were not reported.  They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions. The vial was initially stored in the refrigerator on 4Jun2022.  Treatment medications were not reported.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date; No adverse event; Administered the vaccine after the 30 day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine after the 30 day use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 4-Jun-2022 and administered past 30 day use by date).    No concomitant medications were reported.   The patient received half dose. The vial did not undergo any temperature excursions.  No treatment details were reported
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 04-Jun-2022 and administration of vaccine was on 09-Jul-2022; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 04-Jun-2022 and administration of vaccine was on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 04-Jun-2022 and administration of vaccine was on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 04-Jun-2022 and administration of vaccine was on 09-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 04-Jun-2022 and administration of vaccine was on 09-Jul-2022).    No concomitant medications were provided by the reporter. Date the vial was initially stored in the refrigerator was 04-Jun-2022. The vial did not undergo any temperature excursions. Patient received half dose on 09-Jul-2022.  No treatment medications were provided by the reporter
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site itching; Injection site swelling; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness) in a 40-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form, ADALIMUMAB (HUMIRA) (Subcutaneous) CF,solution for injection in pre-filled pen and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 02-Aug-2022, the patient experienced INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness). At the time of the report, INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness) had not resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for all the events with Humira was a reasonable possibility (probable).  The reporter's causality for all the events with Moderna COVID-19 vaccine and Pfizer Biontech COVID-19 vaccine was a reasonable possibility (possible).  Treatment information was not provided.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022) and NO ADVERSE EVENT (No adverse event) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 07Jul2022).    No concomitant medications were provided by the reporter.  The number of doses/vials administered were 35 vials. Date the vial was initially stored in the refrigerator was 04-Jun-2022. The vaccines were administered from the 04-Jun-2022 until the 26-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medications were provided by the reporter.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022) and NO ADVERSE EVENT (No adverse event) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 20-JUL-2022).    No concomitant medications were reported. The vial was initially stored in the refrigerator on 04-Jun-2022. The date of vaccine administration was from 4-Jun-2022 until 26-Jul-2022. Patient received full dose. The vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Alopecia, Impaired work ability, Swelling
Clinical narrative: SWELLING DUE TO COVID-19 VACCINE; BODY DID NOT WORK LIKE IT USE TO; LOST HAIR DUE TO COVID-19 VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (SWELLING DUE TO COVID-19 VACCINE), IMPAIRED WORK ABILITY (BODY DID NOT WORK LIKE IT USE TO) and ALOPECIA (LOST HAIR DUE TO COVID-19 VACCINE) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) pre-filled pen. On an unknown date, the patient experienced SWELLING (SWELLING DUE TO COVID-19 VACCINE), IMPAIRED WORK ABILITY (BODY DID NOT WORK LIKE IT USE TO) and ALOPECIA (LOST HAIR DUE TO COVID-19 VACCINE). At the time of the report, SWELLING (SWELLING DUE TO COVID-19 VACCINE) and ALOPECIA (LOST HAIR DUE TO COVID-19 VACCINE) had not resolved and IMPAIRED WORK ABILITY (BODY DID NOT WORK LIKE IT USE TO) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were reported. Reporter did not have the lot number information, because the information was not available in the patient file.The reporter causality for the events of swelling due to COVID-19 vaccine, body did not work like it use to and lost hair due to COVID-19 vaccine with co-suspect HUMIRA was reported as no reasonable possibility. No treatment information was reported.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 4-Jun-2022 and was administered on 29-Jul-2022).    No concomitant medication was reported.   Patient received half dose.  The vial was initially stored in the refrigerator was on 04-Jun-2022.  The vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine was kept in refrigerator on 4Jun2022 and administered on 22Jul2022; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (vaccine was kept in refrigerator on 4Jun2022 and administered on 22Jul2022) and NO ADVERSE EVENT (No adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine was kept in refrigerator on 4Jun2022 and administered on 22Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (vaccine was kept in refrigerator on 4Jun2022 and administered on 22Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (vaccine was kept in refrigerator on 4Jun2022 and administered on 22Jul2022).    No concomitant drug information was provided.  Patient had received half dose of the vaccine.  Vial was initially stored in refrigerator on 04-Jun-2022. The product hadn't undergone any temperature excursion issue.  No treatment drug information was provided.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 23-Jul-2022).    No concomitant product use was reported.  Patient had received half dose.  Vial did not undergo any temperature excursions.  No treatment information was provided.