chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs; No adverse event; A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.), PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs) and NO ADVERSE EVENT (No adverse event) in a 29-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. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-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 23-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.), PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs) 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 (A staff member gave 2 Moderna Covid-19 Vaccine, Bivalent booster shots past the 12 hr mark.) and PRODUCT STORAGE ERROR (Dose administered past the 12 hr mark, vial was exposed to room temperature range for 15 hrs).    Concomitant product use was not provided by the reporter.  The size of the vail was 5.5ml. The vial was initially stored in the refrigerator on 22-Sep-2022 at 5:15p and vial was opened for use on 22-Sep-2022 at 5:30p. The vial was first punctured on 22-Sep-2022 at 5:30p. The vial was stored post puncture at Room temperature. The vial did not underwent any temperature excursions. The vial was exposed to room temperature range for 15 hrs.  On 23-Sep-2022, the patient received bivalent booster shots past the 12 hour mark.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-650477 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650477:same reporter
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient was administered underage Moderna 6 months to 5 years vaccine instead of the bivalent Booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was administered underage Moderna 6 months to 5 years vaccine instead of the bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was administered underage Moderna 6 months to 5 years vaccine instead of the bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was administered underage Moderna 6 months to 5 years vaccine instead of the bivalent Booster) 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 WRONG PRODUCT ADMINISTERED (Patient was administered underage Moderna 6 months to 5 years vaccine instead of the bivalent Booster).    No concomitant medications were reported. No treatment information was provided. They had 5 patients scheduled and gave all 5 patients a 0.5 ml dose of the pediatric vaccine when they meant to give them all bivalent boost doses.   This case was linked to US-MODERNATX, INC.-MOD-2022-650478, US-MODERNATX, INC.-MOD-2022-650483, US-MODERNATX, INC.-MOD-2022-650485 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650478: US-MODERNATX, INC.-MOD-2022-650483: US-MODERNATX, INC.-MOD-2022-650485:patient 2
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no adverse event; Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT DOSE ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 21-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent 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 (Adult Patient received 0.5 ml of pediatric vaccine instead of a bivalent Booster dose).    No concomitant medications were reported.   It was reported that, the vaccine administrator grabbed the underage Moderna 6 months to 5 years age vaccine and administered to the adult patient. This case contains information for the 1st of 5 Adult patient described by the reporter.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-650478, US-MODERNATX, INC.-MOD-2022-650483, US-MODERNATX, INC.-MOD-2022-650485 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-650483: US-MODERNATX, INC.-MOD-2022-650485:patient 3 US-MODERNATX, INC.-MOD-2022-650478:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 52-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     Allergies to medication, food and other products were unknown. It was unknown if the patient had ever been diagnosed or tested positive for COVID-19. Chronic and acute illness at the time of vaccination and one month prior was unknown.     On 20-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    The patient received the vaccine on the left. Concomitant medication list was not provided. It was reported that they gave monovalent Moderna COVID-19 vaccines and it was discovered after they had given 21 doses that was expired recently. Vials were individual vials and vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial had not underwent any temperature excursions. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Follow up received: updated reporter details.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown if patient had any allergies to medications, food and other products. It was unknown if patient was ever been diagnosed or tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination or a month before vaccination. Not known if patient had any chronic or long standing health conditions.     On 20-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    No concomitant medication were reported.  Patient received Monovalent vaccine. Individual vials of size 5.5 ml. The vial was initially stored in the refrigerator on 20Sep2022. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live Non-significant follow up received contains: reporter details updated.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: expired vial was initially stored in the refrigerator on 20-Sep-2022; No adverse event; Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown if patient had allergies to medication, foods and other products.   It was unknow if patient had ever been diagnosed with and or tested positive with COVID-19.  Acute illness at the time of vaccination and up to one month before was unknown.     On 20-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-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 received expired vaccine) and PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022).    No concomitant medications were reported.  Patient received 0.5 dose of vaccine at PM time.  Expired Moderna vaccine had been given to 21 patients. The reporter explained that the vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022.  The vial did not undergo any temperature excursion.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received with updated reporter's address.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vial was initially stored in the refrigerator on 20-Sep-2022; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator on 20-Sep-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 (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Expired vial was initially stored in the refrigerator on 20-Sep-2022).    Concomitant product use was not provided by the reporter.  The information was unknown whether the patient had ever been diagnosed with or tested positive with COVID-19.  The information of acute illness at the time of vaccination and up to one month before was unknown.  Expired Moderna vaccine was given to the patient. The vial was taken out of the freezer recently.  The vial size was 5.5 ml.  The vial was initially stored in the refrigerator on 20-Sep-2022.  The vial did not undergo temperature excursion.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-648572 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow-up information received included updated reporters address.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648572:Master case
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: given 21 doses that it was expired recently, had just taken it out of the freezer; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown whether patient had allergies to medications, food and other products. It was unknown if patient was ever been diagnosed or tested positive for COVID-19.  It was unknown if patient had any acute illness at the time of vaccination or a month before vaccination.  It was unknown if patient had any chronic or long standing health conditions.     On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) 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 (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer).    No concomitant medication were reported.  Patient received Monovalent vaccine. Individual vials of size 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergo any temperature excursions  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received contains reporter address updated.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown if patient had allergies to medication, foods and other products.  It was unknow if patient had ever been diagnosed with and or tested positive with COVID-19. Acute illness at the time of vaccination and up to one month before was unknown.     On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 (Expired vaccine used).    No concomitant medications were reported. Expired Moderna vaccine was given to the patient. The vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergo temperature excursion. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received, updated reporter details.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    It was unknown if patient had any allergies to medications, food and other products. It was unknown if patient was ever been diagnosed or tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination or a month before vaccination. Not known if patient had any chronic or long standing health conditions.  No concomitant medication was reported.  Patient received Monovalent vaccine. Individual vials of size 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live non-significant follow up received contains: reporter details updated.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: expired vial was initially stored in the refrigerator on 20-Sep-2022; No adverse event; Expired vaccine was administered after the manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry), PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered after the manufacturer date of expiry) and PRODUCT STORAGE ERROR (expired vial was initially stored in the refrigerator on 20-Sep-2022).    No concomitant medication were reported.  It was reported that patient received 0.5 dose of vaccine during PM time.  It was unknown that patient had ever been diagnosed with nor tested positive for COVID-19. It was unknown if patient had any acute illness at the time of vaccination up to one month before. It was unknown if patient had any chronic or long standing health conditions.  It was reported that HCP gave Moderna Covid 19 vaccines and it was discovered after they had given 21 doses that it was expired recently from  monovalent Individual vials of Vial size 5.5 ml. The vial had not undergone any temperature excursions.  No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-648572 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Follow up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-648572:Master case
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).    No concomitant medications were reported. Anatomical location of administration was reported as left. It was unknown if patient had allergies to medication, foods and other products.  It was unknown if patient had ever been diagnosed with and or tested positive with COVID-19. Acute illness at the time of vaccination and up to one month before was unknown. Expired Moderna vaccine had been given to 21 patients. The reporter explained that the vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergone any temperature excursion. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow-up contains updated reporter details.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown if patient had allergies to medication, foods and other products. It was unknown if patient had ever been diagnosed with and or tested positive with COVID-19. Acute illness at the time of vaccination and up to one month before was unknown. On 20-Sep-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    No concomitant medications were reported.  Expired Moderna vaccine was given to the patient. The vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergo temperature excursion. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow up received, updated reporter details.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: given 21 doses that it was expired recently, had just taken it out of the freezer; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     It was unknown if patient had any allergies to medications, food and other products. It was unknown if patient was ever been diagnosed or tested positive for COVID-19.  It was unknown if patient had any acute illness at the time of vaccination or a month before vaccination.  It was known if patient had any chronic or long standing health conditions.     On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer) 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 (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (given 21 doses that it was expired recently, had just taken it out of the freezer).    No concomitant medication were reported.  Patient received Monovalent vaccine. Individual vials of size 5.5 ml. The vial was initially stored in the refrigerator on 20Sep2022. The vial did not undergo any temperature excursions  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Follow up received: Reporter address updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: Felt dizzy; Had some diarrhea this morning; Her joints are more sore than usual; Had some nausea; Had a headache; Had a bit of a sore arm; Went to bed early as she felt tired; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Felt dizzy), DIARRHOEA (Had some diarrhea this morning), PAIN IN EXTREMITY (Had a bit of a sore arm), FATIGUE (Went to bed early as she felt tired) and ARTHRALGIA (Her joints are more sore than usual) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Lasted for about 5 or 6 days, like a minor cold) on 10-Sep-2022. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, lot number:EJ3002) on 17-Jan-2021, Pfizer (Dose 2, lot number:EJ3002) on 05-Feb-2021, Pfizer (Dose 3 and lot number: FJ1620) on 29-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Arthritis.    On 22-Sep-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. On 22-Sep-2022, the patient experienced PAIN IN EXTREMITY (Had a bit of a sore arm) and FATIGUE (Went to bed early as she felt tired). On 23-Sep-2022, the patient experienced DIZZINESS (Felt dizzy), DIARRHOEA (Had some diarrhea this morning), ARTHRALGIA (Her joints are more sore than usual), NAUSEA (Had some nausea) and HEADACHE (Had a headache). At the time of the report, DIZZINESS (Felt dizzy), DIARRHOEA (Had some diarrhea this morning), PAIN IN EXTREMITY (Had a bit of a sore arm), FATIGUE (Went to bed early as she felt tired), ARTHRALGIA (Her joints are more sore than usual), NAUSEA (Had some nausea) and HEADACHE (Had a headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2022, SARS-CoV-2 test: (Positive) Tested positive by home test.. In September 2022, SARS-CoV-2 test: just had 1 bar, grayish color, on at home test kit. Was told that is because the virus is leaving the body..         No concomitant medication were reported.  It was reported that the Modera bivalent COVID-19 vaccine are more severe than when caller had the pfizer COVID-19 vaccine.  No treatment medications were taken for her symptoms after she received the Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Live follow up received on 26-Sep-2022. Patient demography, relevant history, lab data were updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Felt dizzy; Had some diarrhea this morning; Her joints are more sore than usual; Had some nausea; Had a headache; Had a bit of a sore arm; Went to bed early as she felt tired; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (Felt dizzy), DIARRHOEA (Had some diarrhea this morning), PAIN IN EXTREMITY (Had a bit of a sore arm), FATIGUE (Went to bed early as she felt tired) and ARTHRALGIA (Her joints are more sore than usual) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Lasted for about 5 or 6 days, like a minor cold) on 10-Sep-2022. Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, lot number:EJ3002) on 17-Jan-2021, Pfizer (Dose 2, lot number:EJ3002) on 05-Feb-2021, Pfizer (Dose 3 and lot number: FJ1620) on 29-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Arthritis.    On 22-Sep-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. On 22-Sep-2022, the patient experienced PAIN IN EXTREMITY (Had a bit of a sore arm) and FATIGUE (Went to bed early as she felt tired). On 23-Sep-2022, the patient experienced DIZZINESS (Felt dizzy), DIARRHOEA (Had some diarrhea this morning), ARTHRALGIA (Her joints are more sore than usual), NAUSEA (Had some nausea) and HEADACHE (Had a headache). At the time of the report, DIZZINESS (Felt dizzy), DIARRHOEA (Had some diarrhea this morning), PAIN IN EXTREMITY (Had a bit of a sore arm), FATIGUE (Went to bed early as she felt tired), ARTHRALGIA (Her joints are more sore than usual), NAUSEA (Had some nausea) and HEADACHE (Had a headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2022, SARS-CoV-2 test: (Positive) Tested positive by home test.. In September 2022, SARS-CoV-2 test: just had 1 bar, grayish color, on at home test kit. Was told that is because the virus is leaving the body..         No concomitant medication were reported.  It was reported that the Modera bivalent COVID-19 vaccine are more severe than when caller had the pfizer COVID-19 vaccine.  No treatment medications were taken for her symptoms after she received the Moderna vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Live follow up received on 26-Sep-2022. Patient demography, relevant history, lab data were updated.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Immunisation reaction
Clinical narrative: Moderna's injections kicked my T1D butt; caused my blood sugars to be dangerously low early every morning for about two weeks; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Moderna's injections kicked my T1D butt) and BLOOD GLUCOSE DECREASED (caused my blood sugars to be dangerously low early every morning for about two weeks) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Pfizer booster (Pfizer booster and The patient had no noticeable effect on Pfizer vaccine.). Past adverse reactions to the above products included No adverse event with Pfizer booster.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Moderna's injections kicked my T1D butt) and BLOOD GLUCOSE DECREASED (caused my blood sugars to be dangerously low early every morning for about two weeks). At the time of the report, IMMUNISATION REACTION (Moderna's injections kicked my T1D butt) and BLOOD GLUCOSE DECREASED (caused my blood sugars to be dangerously low early every morning for about two weeks) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: Dangerously low early every morning for about two weeks.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant and treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Follow up received: No new information
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction, Vaccination site warmth
Clinical narrative: my arm was itching / my arm was itchy; my arm was hot; about the size of an orange; it was really really blood red; my arm was hard / my arm was sore to touch; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (my arm was itching / my arm was itchy), VACCINATION SITE WARMTH (my arm was hot), VACCINATION SITE REACTION (about the size of an orange), VACCINATION SITE ERYTHEMA (it was really really blood red) and VACCINATION SITE PAIN (my arm was hard / my arm was sore to touch) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS71625) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Sep-2022, the patient experienced VACCINATION SITE PRURITUS (my arm was itching / my arm was itchy), VACCINATION SITE WARMTH (my arm was hot), VACCINATION SITE REACTION (about the size of an orange), VACCINATION SITE ERYTHEMA (it was really really blood red) and VACCINATION SITE PAIN (my arm was hard / my arm was sore to touch). On 26-Sep-2022, VACCINATION SITE PRURITUS (my arm was itching / my arm was itchy), VACCINATION SITE WARMTH (my arm was hot) and VACCINATION SITE ERYTHEMA (it was really really blood red) had resolved. At the time of the report, VACCINATION SITE REACTION (about the size of an orange) and VACCINATION SITE PAIN (my arm was hard / my arm was sore to touch) outcome was unknown.            Patient got the Moderna Covid-19 Vaccine, Bivalent booster. No concomitant products were reported. No treatment drugs were reported  It was reported that, It's from patient upper shoulder where patient got the shot, to the middle of left forearm.  It was mentioned as Lot: AS71625 ("the last number might be an 8).    This case was linked to MOD-2022-650778.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse Event; Received 0.25ml dose of Bivalent Booster instead of 0.5 ml; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25ml dose of Bivalent Booster instead of 0.5 ml) and NO ADVERSE EVENT (No adverse Event) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-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) .25 milliliter. On 26-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25ml dose of Bivalent Booster instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25ml dose of Bivalent Booster instead of 0.5 ml) 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 ACCIDENTAL UNDERDOSE (Received 0.25ml dose of Bivalent Booster instead of 0.5 ml).    No concomitant drug were reported.   The pharmacist was talking to the patient, who told him to call this number. The patient was told that the pharmacist was supposed to call. The pharmacist states that he will give the patient the other half of the booster dose.  Patient received First dose on 23-MAR-2021,  Lot# 045A21A and Expiration date was reported as unknown. On unknown date patient received second shot of vaccine, Lot number and Expiration date was reported as unknown. On unknown dates patient received 2 Monovalent Booster doses, Lot number and Expiration date was reported as unknown.  No treatment drug were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Follow up document contain secondary reporter was added.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: I had "Covid arm" at the injection site on my left arm. The area was larger than this one (on 26Sep2022). The area was from below the shot to my elbow; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (I had "Covid arm" at the injection site on my left arm. The area was larger than this one (on 26Sep2022). The area was from below the shot to my elbow) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039D21A, 045A21A and 029A21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (I had "Covid arm" at the injection site on my left arm. The area was larger than this one (on 26Sep2022). The area was from below the shot to my elbow). At the time of the report, VACCINATION SITE REACTION (I had "Covid arm" at the injection site on my left arm. The area was larger than this one (on 26Sep2022). The area was from below the shot to my elbow) had not resolved.      No concomitant medications were reported. Patient reported that the area was larger than the previous one on 26-Sep-2022. No treatment medications were reported.   This case was linked to MOD-2022-650770 (Patient Link).
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: It might be close to 10 weeks before they get their 2nd dose; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (It might be close to 10 weeks before they get their 2nd dose) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (It might be close to 10 weeks before they get their 2nd dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (It might be close to 10 weeks before they get their 2nd dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  Two years old patient received their 1st dose of Moderna Covid-19 vaccine at the end of July 2022. It might be close to 10 weeks before they get their 2nd dose.They could not get it sooner, because of their schedule.  No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: potential side effects after taking a Moderna vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (potential side effects after taking a Moderna vaccine) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-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 an unknown date, the patient experienced IMMUNISATION REACTION (potential side effects after taking a Moderna vaccine). At the time of the report, IMMUNISATION REACTION (potential side effects after taking a Moderna vaccine) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2022: Non Significant Follow-up received.