chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 85.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23; No adverse event; HCP stated accidentally administered 2 doses after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated accidentally administered 2 doses after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23) and NO ADVERSE EVENT (No adverse event) in an 85-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     The patient had no known conditions for relevant medical history, allergy, concomitant diseases and risk factors. The patient received no other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna (Dose 3, Lot: 017F21A, Intramuscular, Right arm and 0.25 ml.) on 26-Oct-2021. Past adverse reactions to the above products included No adverse event with Moderna.    On 21-Mar-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 21-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated accidentally administered 2 doses after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated accidentally administered 2 doses after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23) 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 (HCP stated accidentally administered 2 doses after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored on 17-Feb-2023 and administered on 21-Mar-23).    No concomitant information was reported. No treatment information was reported. The case belongs to the patient number 2 out of two patients reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716779 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2023: Significant follow-up: Patient and Dosage information updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716779:Patient 1-Adult
Sex: U
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: No side effects; PROQUAD was unknowingly administered in 2021; This spontaneous report was received from a medical assistant, concerning a currently 2 year old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.   On an unspecified date in 2021, the patient was unknowingly vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). No side effects were reported.
Sex: U
Vaccine: PNC15
Symptoms: No adverse event, Poor quality device used, Syringe issue
Clinical narrative: No additional AE reported; syringes broke/ the second broke after administration to a patient on 23MAR2023; the second broke after administration to a patient on 23MAR2023; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 23-MAR-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (CRM197) (VAXNEUVANCE) 0.5 ml 1DS X 10 syringes (lot#: W027275, expiration date: 09-JUL-2024, NDC: 00064329-03; does, anatomical location, and route of administration were not reported) for prophylaxis. The syringe broke into pieces at the Luer lock after administration (syringe issue and poor quality device used). There were no difficulties trying to attach the syringe needle to the syringe. The syringe was not supplied by the company and the size was a BD safety glide needle 23-gauge, 1 inch. The syringe tip cap was attached to properly prior to use with intact and undamaged status. No additional adverse event (AE) was reported (no adverse event).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: no additional AE's were reported; patient was administered an expired dose of PNEUMOVAX 23.; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's pertinent medical history, drug reactions/allergies, and concomitant therapies were not reported.  On 30-MAR-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot # U027357 (Lot number U027357 has been verified to be valid for pneumococcal vaccine, polyvalent [23-valent]), expiration date: 25-MAR-2023 (expired product administered) intramuscularly, as prophylaxis.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported. No additional AE/No PQC; HCP called to report a TE with GARDASIL 9. Stored out of range and administered; This spontaneous report was received from a physician referring to a male patient of an unknown age and race.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 24-MAR-2023, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, 0.5 mL (lot # W009829, expiration date: 19-OCT-2024), administered as prophylaxis (strength, anatomical location, and route of administration were not provided), and which had a temperature excursion as it was stored out of range (product storage error). Nonetheless, no adverse effects were reported (no adverse event).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AE's were reported.; The patient was administered and expired dose of MMR-II.; This spontaneous report was received from a Licensed practical nurse regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-MAR-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 milliliter, lot #U009511, expiration date: 25-MAR-2023, administered subcutaneously as prophylaxis (strength was not provided) (Expired product administered). No adverse events were reported.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Medical assistant called for evaluation of VARIVAX that was mistakenly stored in the refrigerator on 30Mar2023.  On the following day 31Mar2023, the product was administered to a patient.  Medical assistant requested AE Follow Up letter be addressed; This spontaneous report has been received from a medical assistant, regarding a 12-months-old female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 30-mar-2023, a vial of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection was mistakenly stored on a refrigerator.  Then on 31-MAR-2023, the patient was vaccinated with a dose of this varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliters (ml) as prophylaxis (lot number: W006413,which was determined to be valid, with an expiration date on 23-FEB-2024) (strength, route and anatomical location of administration were not reported) The administered dose underwent a temperature excursion of 4 degrees Celsius (C) for 24 hours. There was not any previous temperature excursion reported.   No additional adverse event was reported, and no further information provided.
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product preparation error
Clinical narrative: the patients family has not called in or reported any issues/specific adverse events; diluent from HAVRIX vaccine (0.4 % Sodium Chloride) was used to reconstitute MMRII; This spontaneous report was received from a nurse and refers to a 12-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions included cat allergies. Concomitant therapies were not reported.   On 15-FEB-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot #W009105, expiration date: 04-DEC-2023 (strength, route of administration, and indication were not provided) diluted on 0.4 percent sodium chloride (HAVRIX DILUENT) lot #EE542, expiration date: 23-FEB-2024 as vaccine diluent (route of administration was not provided) (Wrong solution used in drug reconstitution). No additional adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported. No additional Adverse events or PQC reported; HCP called to report a TE with GARDASIL 9.  Stored out of range and administered.; This spontaneous report has been received from a consumer regarding a patient of unknown age and gender. Patient's pertinent medical history, drug reactions and allergies and concomitant medication were unknown by reporter.  On 24-MAR-2023, the patient was vaccinated with an improper storage dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), injection, at a dose of 0.5 milliliter for propylaxis, (strength, route of administration, and anatomical location were not provided; lot number W009829 had been verified as a valid number, expiration date had been reported and established as 19-OCT-2024) (product storage error).  There was no adverse event reported and no product quality complain (no adverse event).
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in refrigerator on 23-Dec-2022 and was administered on 26-Jan-2023; No adverse event; pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 23-Dec-2022 and was administered on 26-Jan-2023) and NO ADVERSE EVENT (No adverse event) in a child 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. 216K22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 26-Jan-2023, 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 26-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 23-Dec-2022 and was administered on 26-Jan-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 23-Dec-2022 and was administered on 26-Jan-2023) 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 (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 23-Dec-2022 and was administered on 26-Jan-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported. It was reported that the bivalent 6m-5y vial of size 0.4 ml was not exposed to temperature excursion.  Treatment medications were not provided.  This case was reported for patient 26 out of 42.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:(Patient no- 26 out of 42 patients)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine went under temperature excursion; No adverse event; Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In March 2023, 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that the day after power was lost in the middle of the day at 12:00 pm and had to placed all vaccine in a frozen bag. Booster vaccines were then transported to another clinic. No symptoms were reported. This case is reported for patient 5 out of 26 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Lost power the next day in the middle of the day at 12:00 PM.; Had placed all vaccine into a frozen bag, booster vaccines were then transported to another clinic and was adminstered between 02-MAR-2023 to 28-MAR-2023.; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Had placed all vaccine into a frozen bag, booster vaccines were then transported to another clinic and was adminstered between 02-MAR-2023 to 28-MAR-2023.) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Had placed all vaccine into a frozen bag, booster vaccines were then transported to another clinic and was adminstered between 02-MAR-2023 to 28-MAR-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Had placed all vaccine into a frozen bag, booster vaccines were then transported to another clinic and was adminstered between 02-MAR-2023 to 28-MAR-2023.) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and POOR QUALITY PRODUCT ADMINISTERED (Had placed all vaccine into a frozen bag, booster vaccines were then transported to another clinic and was adminstered between 02-MAR-2023 to 28-MAR-2023.).    No concomitant medications were reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported than, on 02-Mar-2023 to 28-Mar-2023, vaccines were administered to 26 Patients at facility. No treatment details were reported.  This case was reported for Patient 9 out of 26 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Patient 1 (Master Case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Lost power the next day in the middle of the day at 12:00 PM.; No adverse event; Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Lost power the next day in the middle of the day at 12:00 PM.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went tempearture excursion and was adminstered between 02-MAR-2023 to 28-MAR-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  Temperature excursion occurred due to lost power in the middle of the day at 12:00 PM. Had placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. On 02-Mar-2023 to 28-Mar-2023, vaccines were administered to 26 Patients at facility. No reported symptoms.  No treatment medications was reported.  This case was reported for Patient 19 out of 26 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Patient 1 (Master Case)
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Product temperature excursion issue; No adverse event; Patient received vaccine after temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  In March 2023, 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) 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 POOR QUALITY PRODUCT ADMINISTERED (Patient received vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue).    No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Lost power the next day in the middle of the day at 12:00 PM. Had placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. On 2-Mar-2023-28-Mar-2023 vaccines were administered to 26 patients. No reported symptoms.  No treatment medications were reported.  This case contains information for the 6th of 26th adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion with AE; No adverse event; Temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with AE) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In March 2023, 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with AE) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with AE) 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 POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion with AE).    Concomitant medication was not provided.  It was reported that lost power the next day in the middle of the day at 12:00 PM and placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic.  Treatment information was not provided.  This case contains information for the 16th patient out of 26 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: temperature excursion with AE; No adverse event; vaccines were administered to 26 patients; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccines were administered to 26 patients), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In March 2023, 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines were administered to 26 patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (vaccines were administered to 26 patients), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE) 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 POOR QUALITY PRODUCT ADMINISTERED (vaccines were administered to 26 patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion with AE).    No concomitant medication were reported.  It was reported that Lost power the next day in the middle of the day at 12:00 PM. All the vaccine were placed into a frozen bag. Booster vaccines were then transported to another clinic. On 2-MAR-2023 to 28-MAR-2023 vaccines were administered to 26 patients. No reported symptoms.  No treatment information was provided by the reporter.  This case is of Patient 26 out of 26 Patients, as mentioned by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine went under temperature excursion; No adverse event; Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In March 2023, 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023).    No concomitant medications were provided. It was reported that due to lost power in the middle of the day at 12:00 PM, had to place all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. No symptoms were reported. No treatment medication was provided. This case contains information for the 3rd of 26 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine went under temperature excursion; No adverse event; Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine.     In March 2023, 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-MAR-2023 to 28-MAR-2023.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that the day after power was lost in the middle of the day at 12:00 pm and had to placed all vaccine in a frozen bag. Booster vaccines were then transported to another clinic. No symptoms were reported. This case is reported for patient 13 out of 26 patients. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine went under temperature excursion; No adverse event; Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023; This spontaneous case was reported by a consumer and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2023, 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023), PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion).    Concomitant medication details not reported by the reporter. Reporter reported that lost power the next day in the middle of the day at 12:00 PM. Had placed all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. On 2-MAR-2023-28-MAR-2023 vaccines were administered to 26 patients.  Treatment details was not reported by the reporter. This case contains information for the 23rd patient out of 26 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19; COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of the first episode of COVID-19 (COVID-19) and the second episode of COVID-19 (COVID-19) in an adult female 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.   Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Patient had 5 shots and and all were Moderna.). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On an unknown date, 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. In December 2022, the patient experienced the first episode of COVID-19 (COVID-19). In January 2023, the patient experienced the second episode of COVID-19 (COVID-19). At the time of the report, last episode of COVID-19 (COVID-19) had resolved.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  The patient said that they got COVID in December 2022 and January 2023. The symptoms were mild.  No treatment drug was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-717679 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717679:Husband case
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Neurofibromatosis
Clinical narrative: kind of skin disorder - neurofibromatosis which are benign tumors/The neurofibromatosis got worse after the 1st dose and it got even worse after the 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of NEUROFIBROMATOSIS (kind of skin disorder - neurofibromatosis which are benign tumors/The neurofibromatosis got worse after the 1st dose and it got even worse after the 2nd dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Weight loss (since she lost over a 100 lbs 3 years ago.) and Neurofibromatosis (She had it since she was a teenager.). Concurrent medical conditions included Blood pressure (She said that her BP has been fine.).   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROFIBROMATOSIS (kind of skin disorder - neurofibromatosis which are benign tumors/The neurofibromatosis got worse after the 1st dose and it got even worse after the 2nd dose). At the time of the report, NEUROFIBROMATOSIS (kind of skin disorder - neurofibromatosis which are benign tumors/The neurofibromatosis got worse after the 1st dose and it got even worse after the 2nd dose) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Patient reported that she had the 2 Moderna shots and have a kind of skin disorder neurofibromatosis which are benign tumors. She had it since she was a teenager. She further stated gotten worse after she got the 2 shots. Caller did not have the vaccination card at the time of the call but states that she had the 1st and 2nd doses in 2021. The neurofibromatosis got worse after the 1st dose and it got even worse after the 2nd dose.  Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Dose administered after manufacturer date of expiry; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and 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 (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 (Dose administered after manufacturer date of expiry).    No concomitant medication details was reported. The vial was initially stored in the refrigerator on 23-Mar-2023. The vial did not undergo any temperature excursions. No treatment medication details was reported.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; A expired vaccine was administer to a patient. Vaccine Expired on 04/01/2023 and it was administer 04/03/2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A expired vaccine was administer to a patient. Vaccine Expired on 04/01/2023 and it was administer 04/03/2023.) and NO ADVERSE EVENT (No adverse event) in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE on 28-Feb-2023. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE.    On 03-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (A expired vaccine was administer to a patient. Vaccine Expired on 04/01/2023 and it was administer 04/03/2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A expired vaccine was administer to a patient. Vaccine Expired on 04/01/2023 and it was administer 04/03/2023.) 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 (A expired vaccine was administer to a patient. Vaccine Expired on 04/01/2023 and it was administer 04/03/2023.).    No concomitant medications was provided. No treatment medications was provided. Vial size was  5.5mL  Date the vial was initially stored in the refrigerator was unknown. Reporter said the box just has expiration date but no date that it was moved from freezer to fridge. They only have the date they received them which was 28Nov2022. Normally the procedure was they write the date it was removed from the freezer to the fridge.
Sex: U
Vaccine: COVID19-2, COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Vaccine went under temperature excursion; No adverse event; Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023) and NO ADVERSE EVENT (No adverse event) in an adult 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. 066H22A) for COVID-19 prophylaxis.     It was unknown that patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In March 2023, 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. In March 2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine went under temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine went temperature excursion and was administered between 02-Mar-2023 to 28-Mar-2023).    No concomitant medications were provided. It was reported that due to lost power in the middle of the day at 12:00 PM, had to place all vaccine into a frozen bag. Booster vaccines were then transported to another clinic. No symptoms were reported. No treatment medication was provided. This case contains information for the 4th out of 26 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718370 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718370:Master case