chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-2022; No adverse event; Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-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 given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-2022).    Concomitant Medication use information was not provided by reporter.  It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 days beyond use date 22-Sep-2022.  There were unbroken cartons. Vial size for 6 months to 5 years was 2.5 ml. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient was given vaccine after BUD date.   The vial did not undergo any temperature excursions.  No reported adverse events.  Treatment Medication use information was not provided by reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient had COVID Disease 6 months after the 2nd Monovalent booster; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient had COVID Disease 6 months after the 2nd Monovalent booster) 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 January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2022, the patient experienced COVID-19 (Patient had COVID Disease 6 months after the 2nd Monovalent booster). At the time of the report, COVID-19 (Patient had COVID Disease 6 months after the 2nd Monovalent booster) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2022, SARS-CoV-2 test: Positive.         Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; patient received an expired Monovalent first dose of Moderna COVID-19 vaccine beyond Expiry Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent first dose of Moderna COVID-19 vaccine beyond Expiry Date) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent first dose of Moderna COVID-19 vaccine beyond Expiry Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent first dose of Moderna COVID-19 vaccine beyond Expiry 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (patient received an expired Monovalent first dose of Moderna COVID-19 vaccine beyond Expiry Date).    Concomitant drugs were not reported.  It was reported that the monovalent individual vial of 5.5 ml red cap was initially stored in refrigerator on 01-Dec-2022. The vial did not undergo any temperature excursion.  Treatment medications were not provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine was stored in the refrigerator; No adverse event; patient received an expired dose as a 5th dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received an expired dose as a 5th dose), PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 064a22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received an expired dose as a 5th dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received an expired dose as a 5th dose), PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (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 received an expired dose as a 5th dose) and PRODUCT STORAGE ERROR (Expired vaccine was stored in the refrigerator).    Concomitant medications details were not reported by the reporter.  Vial size was reported as 2.5 ml. Vial was initially stored in refrigerator on 01-DEC-2022. Vial did not undergo any temperature excursion.  Treatment details were not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was moved into the refrigerator on 10/28/22 and administered to the patient on 11/29/22; no adverse event; Moderna vaccine administered to patient after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered to patient after 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was moved into the refrigerator on 10/28/22 and administered to the patient on 11/29/22) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered to patient after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was moved into the refrigerator on 10/28/22 and administered to the patient on 11/29/22) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered to patient after 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was moved into the refrigerator on 10/28/22 and administered to the patient on 11/29/22) 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 (Moderna vaccine administered to patient after 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was moved into the refrigerator on 10/28/22 and administered to the patient on 11/29/22).    No concomitant medications were reported. The vaccine was stored in the freezer upon receipt.  It was moved into the refrigerator on 10/28/22, giving it a beyond use date of 11/27/22.  The vaccine was administered to a patient on 11/29/22. The manufacturer date was reported as 3/11/22. No treatment medications were reported.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; We gave 4 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine) and NO ADVERSE EVENT (no adverse event) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Covid-19 vaccine).    Concomitant products were not reported.  It was reported that monovalent 4 doses were administered. Vial size was reported as 5.5ml. The vial was initially stored in the refrigerator on 02-Nov-2022. The vial did not undergo any temperature excursions.   Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681659 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681659:Same reporter
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Both had some tummy issues after receiving it; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ABDOMINAL DISCOMFORT (Both had some tummy issues after receiving it) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Both had some tummy issues after receiving it). At the time of the report, ABDOMINAL DISCOMFORT (Both had some tummy issues after receiving it) outcome was unknown.     No concomitant medications were reported. Patient and patient's daughter received booster shot on Monday and both had some tummy issues after receiving it.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-681730 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681730:MOD-2022-681730 -Daughter case
Age: 80.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Product storage error; No adverse event; Given vaccine which was beyond the 30 day use by date; Given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion). On 22-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant products reported. It was reported that the lot number underwent temperature excursion on 15 to 17-Aug-2022 and was administered to the patient post temperature excursion.  No treatment products reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2022: Live follow up received contains significant information: Updated patient demographics and event (expired vaccine use)
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: given expired vaccine; No adverse event; given expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given expired vaccine), PRODUCT STORAGE ERROR (given expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given expired vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given expired vaccine), PRODUCT STORAGE ERROR (given expired vaccine) 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 (given expired vaccine) and PRODUCT STORAGE ERROR (given expired vaccine).    No concomitant medications were reported.  A nurse reported that they had 2 patients who were given expired doses of the Moderna vaccine on 30-Nov-2022. Manufacturer expiration date was reported as 28-Nov-2022. Patient had not reported any adverse events. Vial size was reported as 5.5ml.  On 29-Nov-2022, the vial was initially stored in the refrigerator.  On 30-Nov-2022, the patient administered vaccine at 1:00 or 2:00pm.   The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Immunisation reaction, SARS-CoV-2 test
Clinical narrative: mild reactions (unspecified) after all 4 Moderna shots during 48 hours; sick; Patient got COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (mild reactions (unspecified) after all 4 Moderna shots during 48 hours), ILLNESS (sick) and COVID-19 (Patient got COVID-19) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no allergies.  The patient's past medical history included COVID-19 in April 2020. Concurrent medical conditions included HDL cholesterol increased (taking Praluent for HDL cholesterol adjustments). Concomitant products included ALIROCUMAB (PRALUENT) for HDL cholesterol increased.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (Patient got COVID-19). On an unknown date, the patient experienced IMMUNISATION REACTION (mild reactions (unspecified) after all 4 Moderna shots during 48 hours) and ILLNESS (sick). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, IMMUNISATION REACTION (mild reactions (unspecified) after all 4 Moderna shots during 48 hours) had resolved and ILLNESS (sick) and COVID-19 (Patient got COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2020, SARS-CoV-2 test: Positive. In July 2022, SARS-CoV-2 test: Positive.         The reporter stated that he did not remember if his wife (patient) started taking Praluent before or after any Moderna COVID-19 vaccination. The reporter did not remember the dates for the previous vaccinations but stated that her wife had already received 4 Moderna shots (included first and second booster doses).  The patient experienced mild reactions (unspecified) after each injection but it was resolved within 48 hours and the patient might have took Tylenol, Ibuprofen or Advil to treat symptoms.   This case was linked to MOD-2022-681975 (Patient Link).
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: No adverse event; Given vaccine which was beyond the 30 day use by date; Given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Aug-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion). On 17-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion) and EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date).    No concomitant products reported.  It was reported that the lot number underwent temperature excursion on 15 to 17 Aug 2022 and was administered to 16 patients post temperature excursion.   No treatment products reported.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Wrong product administered
Clinical narrative: illness; inadvertently gave the Moderna Monovalent vaccine as the Bivalent dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (illness) and WRONG PRODUCT ADMINISTERED (inadvertently gave the Moderna Monovalent vaccine as the Bivalent dose) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2022 at 2:00 AM, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 30-Nov-2022 at 2:00 AM, the patient experienced WRONG PRODUCT ADMINISTERED (inadvertently gave the Moderna Monovalent vaccine as the Bivalent dose). On an unknown date, the patient experienced ILLNESS (illness). At the time of the report, ILLNESS (illness) and WRONG PRODUCT ADMINISTERED (inadvertently gave the Moderna Monovalent vaccine as the Bivalent dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Pharmacist reported that a technician inadvertently gave the Moderna Monovalent vaccine as the Bivalent dose to an adult male patient on 30-Nov-2022 around 2 PM. The customer wants to return to be vaccinated. What was the guidance. Treatment details were not reported by the reporter.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: No adverse event; Given vaccine which was beyond the 30 day use by date; Given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event) in a 47-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion). On 31-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date), PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date) and PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion).    No concomitant products reported. It was reported that the lot number underwent temperature excursion on 15 to 17 Aug 2022 and was administered to the patient post temperature excursion.  No treatment products reported.
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Product storage error; No adverse event; Given vaccine which was beyond the 30 day use by date; Given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Product storage error) 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. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion). On 19-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant products reported. It was reported that the lot number underwent temperature excursion on 15 to 17-Aug-2022 and was administered to the patient post temperature excursion.  No treatment products reported.
Age: 82.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: No adverse event; Given vaccine which was beyond the 30 day use by date; Given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion). On 19-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion) and EXPIRED PRODUCT ADMINISTERED (Given vaccine which was beyond the 30 day use by date).    No concomitant medicine were reported. No treatment medicine were reported.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product temperature excursion issue
Clinical narrative: No adverse event; given vaccine which was beyond the 30 day use by; Given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by), PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion). On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by), PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by) and PRODUCT TEMPERATURE EXCURSION ISSUE (Given vaccine which underwent temperture excursion).    No concomitant medicine were reported. No treatment medicine were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-682168 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682168:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: given vaccine which underwent temperture excursion; No adverse event; given vaccine which underwent temperture excursion; given vaccine which was beyond the 30 day use by date; vaccine which underwent temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion). On 19-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (given vaccine which underwent temperture excursion) and EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (given vaccine which underwent temperture excursion).    No concomitant medicine were reported.  I t was reported that the vaccine lot had undergone temperature excursion between 15 -17 AUG 2022.   No treatment medicine were reported.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: given vaccine which underwent temperture excursion; No adverse event; given vaccine which underwent temperture excursion; given vaccine which was beyond the 30 day use by date; vaccine which underwent temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion). On 19-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (given vaccine which underwent temperture excursion) and EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (given vaccine which underwent temperture excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (vaccine which underwent temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (given vaccine which underwent temperture excursion).    No concomitant medicine were reported.  I t was reported that the vaccine lot had undergone temperature excursion between 15 -17 AUG 2022.   No treatment medicine were reported.
Age: 21.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: given vaccine which was beyond the 30 day use by date; No Adverse event; given vaccine which was beyond the 30 day use by date; given vaccine which underwent temperture excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No Adverse event) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion). On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date).    Concomitant medications were not reported. HCP reports that one of their providers had a lot number which underwent temperature excursion on 15-17Aug2022 and was administered to 16 patients post temperature excursion.                                No treatment information was provided by the reporter.
Age: 21.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: given vaccine which was beyond the 30 day use by date; No Adverse event; given vaccine which was beyond the 30 day use by date; given vaccine which underwent temperture excursion; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No Adverse event) in a 21-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion). On 19-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (given vaccine which was beyond the 30 day use by date).    Concomitant medications were not reported. HCP reports that one of their providers had a lot number which underwent temperature excursion on 15-17Aug2022 and was administered to 16 patients post temperature excursion.                                No treatment information was provided by the reporter.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 2 doses were given beyond the 30 day refrigeration date (BUD).; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses were given beyond the 30 day refrigeration date (BUD).) and NO ADVERSE EVENT (No adverse event) in a 44-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses were given beyond the 30 day refrigeration date (BUD).). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses were given beyond the 30 day refrigeration date (BUD).) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 doses were given beyond the 30 day refrigeration date (BUD).).    No concomitant medication was reported. No treatment medication was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No Adverse event; given vaccine which was beyond the 30 day use by date; Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022; given vaccine which underwent temperture excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No Adverse event) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022). On 19-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (given vaccine which underwent temperture excursion), EXPIRED PRODUCT ADMINISTERED (given vaccine which was beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 15-Aug-2022 and was administered on 19-Sep-2022).    Concomitant medication not reported.  Storage condition at the time of the excursion: frozen storage / refrigerated storage / ambient room temperature: fridge. Vial size: 5.5ml Maximum or minimum temperatures reached, as applicable (specify temp is in C or F): 0.29C (cold excursion) Excursion duration: 32hours and 30 min Date vial(s) moved from freezer to refrigerator, if applicable:15-Aug-2022. Where are they stored now: Returned to the freezer/refrigerator or maintained at room temperature - disposed as it was expired. Treatment medication not reported.