chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; Vaccines administered after being in stored in fridge past 30 days; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event) in a 67-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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) 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 (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days).    No concomitant medication was reported. No treatment medication was reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:same reporter
Age: 76.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines administered after being in stored in fridge past 30 days; Vaccines administered after being in stored in fridge past 30 days; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event) in a 76-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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) 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 (Vaccines administered after being in stored in fridge past 30 days) and PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days).    Concomitant medication not reported.  Treatment medication not reported.
Age: 74.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Expired vaccine administered to patient; Vaccines administered after being in stored in fridge past 30 days; Patient received Moderna bivalent vaccine as First dose; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose) and NO ADVERSE EVENT (no adverse event) in a 74-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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose) 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 (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:Same reporter
Age: 67.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccines administered after being in stored in fridge past 30 days; Vaccines administered after being in stored in fridge past 30 days; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event) in a 67-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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second 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 EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) 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 (Vaccines administered after being in stored in fridge past 30 days) and PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days).    Concomitant medication not reported.  Treatment medication not reported.
Age: 72.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Vaccines administered beyound 30-day use by date; Vaccines administered after being in stored in fridge past 30 days; Patient received first dose of primary series from Moderna Bivalent vaccine; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a 72-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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine) 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 (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and WRONG PRODUCT ADMINISTERED (Patient received first dose of primary series from Moderna Bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.
Age: 71.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Vaccines administered beyound 30-day use by date; Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a 71-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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) 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 (Vaccines administered beyound 30-day use by date), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:Same reporter
Age: 92.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expired vaccine administered to patient; Vaccines administered after being in stored in fridge past 30 days; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (No adverse event) in a 92-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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) 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 (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:Same reporter
Age: 52.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a 52-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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) 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 (Vaccines administered after being in stored in fridge past 30 days) and WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 72.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Vaccines administered after being in stored in fridge past 30 days; Vaccines administered after being in stored in fridge past 30 days; Patient received Moderna bivalent vaccine as First dose; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose) and NO ADVERSE EVENT (no adverse event) in a 72-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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose) 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 (Vaccines administered after being in stored in fridge past 30 days), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and WRONG PRODUCT ADMINISTERED (Patient received Moderna bivalent vaccine as First dose).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:Same Reporter
Age: 74.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.; Vaccine was administered to patient after temperature excursion occurred.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred.) and NO ADVERSE EVENT (No adverse event) in a 74-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 05D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Prostate cancer.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred.) 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 (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred.).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.; Vaccine was administered to patient after temperature excursion occurred; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) and NO ADVERSE EVENT (No adverse event) in a 73-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 05D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Parkinson's disease, Hypertension and Hyperlipidemia.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.), POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred) 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 (HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23.) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine was administered to patient after temperature excursion occurred).    No concomitant medication was reported.  HCP advised that her office administered vaccines that were reported being out of temperature on 2-24-23. No confirmation was provided on viability of vaccine vails and as a result office continued to perform vaccination with vials until 5-30-23. Up to 14 vaccination were administered within that time line. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730480 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730480:Same reporter
Age: 81.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; Vaccines administered after being in stored in fridge past 30 days; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event) in an 81-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. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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 EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) 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 (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days).    No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:same reporter
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Interchange of vaccine products, Pain, SARS-CoV-2 test
Clinical narrative: body aches; Chronic fatigue; light headed feelings; Dose 4: Moderna and dose 5: Comirnaty; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Interstitial cystitis" (unspecified if ongoing); "BPH" (unspecified if ongoing); "mild high blood pressure" (ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation as dose number unknown, single; ATENOLOL; FLOMAX [TAMSULOSIN HYDROCHLORIDE]; ATORVASTATIN; VITAM [ASCORBIC ACID]. Vaccination history included: coviD-19 vaccine moderna (DOSE 4 (BOOSTER), SINGLE , Lot number: 037A22B, vaccine location: Right arm), administration date: 06Jun2022, when the patient was 63-year-old, for COVID-19 Immunization; BNT162b2 (DOSE  3 (BOOSTER), SINGLE , Lot Number: FG3527, prev dose vaccine location: Left arm), administration date: 23Nov2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE , Lot Number: EW0170, vaccine location: Left arm), administration date: 30Apr2021, when the patient was 62-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 1, SINGLE , Lot Number: ER0734, vaccine location: Left arm), administration date: 09Apr2021, when the patient was 62-year-old, for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 28Oct2022, outcome "not recovered", described as "Dose 4: Moderna and dose 5: Comirnaty"; FATIGUE (non-serious) with onset 31Oct2022, outcome "not recovered", described as "Chronic fatigue"; PAIN (non-serious) with onset 31Oct2022, outcome "not recovered", described as "body aches"; DIZZINESS (non-serious) with onset 31Oct2022, outcome "not recovered", described as "light headed feelings". The events "body aches", "chronic fatigue" and "light headed feelings" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, fatigue, dizziness.  Additional Information: Other vaccines were taken within 4 weeks. Other medications like antibiotics, atenolol, flomax, atorvastatin, vitamin were taken in 2 weeks. There was no treatment taken for adverse event. No known allergies. No Covid prior to vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal disorder, Peripheral swelling
Clinical narrative: my arm is a little bit weaker than it was / left arm lost strength, received vaccine in left arm; it feels a little different, it functions and everything/ left arm is not functioning at 100% like used to; a little bit swollen in the right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), in Feb2022 as dose 3 (booster), single (Lot number: FK9896), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Mar2021, for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "my arm is a little bit weaker than it was / left arm lost strength, received vaccine in left arm"; MUSCULOSKELETAL DISORDER (non-serious), outcome "unknown", described as "it feels a little different, it functions and everything/ left arm is not functioning at 100% like used to"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "a little bit swollen in the right arm". Additional information: On Mar2021, Patient received two doses of vaccine from Pfizer and last year on Feb patient was given third booster shot. Ever since he received, his arm was little bit weaker than it was, it felt little different, its function and everything. He did workout all the time and he could tell difference in the arm. His muscle was little bit swollen in the right arm when before it was pretty even. Patient does not have pain, it just felt different. Caller was advised Pfizer does not provide treatment recommendations. Patient never had COVID prior or after the vaccine and that he has been tested few times. Over the period of a year and some change left arm lost strength, received vaccine in left arm, left arm strength is about 80% of what it was. left arm is not functioning at 100% like used to and the left arm is where caller received the vaccine. Left arm was not functioning at 100% like used to and the left arm was where caller received the vaccine. On 14Jul caller has physical coming up, going to discuss this information at that time with doctor.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Muscle twitching
Clinical narrative: Muscle spasms and twitches throughout body; Muscle spasms and twitches throughout body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 at 14:00 as dose 2, single (Lot number: FJ1620) at the age of 20 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FJ1620, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 13Mar2022, when the patient was 20-year-old, for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious), MUSCLE TWITCHING (non-serious) all with onset 04May2022, outcome "not recovered" and all described as "Muscle spasms and twitches throughout body". The events "muscle spasms and twitches throughout body" required physician office visit. Therapeutic measures were not taken as a result of muscle spasms, muscle twitching.  Additional Information: The patient had not taken other vaccine in four weeks. The adverse event was described by the patient as Muscle spasms and twitches throughout her body. Patient did not have Covid prior to vaccination; also not tested for Covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EN5318) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Clinical depression" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional Information: No reactions to vaccinations other than sore arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231836 same patient, different vaccine dose/event;US-PFIZER INC-202300232002 same patient, different vaccine dose/event;US-PFIZER INC-202300232003 same patient, different vaccine dose/event;US-PFIZER INC-202300232004 same patient, different vaccine dose/event;US-PFIZER INC-202300232005 same patient, different vaccine dose/event;
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 2, single (Lot number: EN6199) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Clinical depression" (unspecified if ongoing); "type 2 diabetes" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "known allergies: Compazine". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EN5318, Location of injection: Arm Left), administration date: 02Feb2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm.  Additional Information: No reactions to vaccinations other than sore arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231836 same patient, different dose/event;US-PFIZER INC-202300231837 same patient, different vaccine dose/event;US-PFIZER INC-202300232004 same patient, different vaccine dose/event;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "Clinical depression" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Allergy: Compazine". Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 02Mar2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "Sore arm"; BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EN5318, Location of injection: Arm Left), administration date: 02Feb2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231836 same reporter/patient/product, different dose/event;US-PFIZER INC-202300231837 same patient, different vaccine dose/event;US-PFIZER INC-202300232004 same patient, different vaccine dose/event;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing), notes: other medical history: Clinical depression type 2 diabetes; "Clinical depression" (unspecified if ongoing), notes: other medical history: Clinical depression type 2 diabetes. The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine", notes: Known allergies: Compazine. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: EN5318, Location of injection: Arm Left), administration date: 02Feb2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "sore arm"; BNT162b2 (DOSE 2, SINGLE, Batch/Lot No: EN6199, Location of injection: Arm Left), administration date: 02Mar2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "sore arm"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Location of injection: Arm Left, Batch/ Lot number not reported), administration date: 27Sep2021, when the patient was 67-year-old, for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "sore arm".  Additional Information: No reactions to vaccinations other than sore arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231836 same patient, different vaccine dose/event;US-PFIZER INC-202300231837 same patient, different vaccine dose/event;US-PFIZER INC-202300232002 same patient, different vaccine dose/event;US-PFIZER INC-202300232005 same patient, different vaccine dose/event;US-PFIZER INC-202300232003 same patient, different vaccine dose/event;US-PFIZER INC-202300231837 same patient, different vaccine dose/event;
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Clinical depression" (unspecified if ongoing); "type 2 diabetes" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "Known allergies: Compazine"; Bnt162b2, start date: 01Apr2022, stop date: 01Apr2022, for Covid-19 Immunization, reaction(s): "sore arm", notes: DOSE 4 (BOOSTER), SINGLE , vaccine lot Number: FK9895, Vaccine location: Left arm; Bnt162b2, start date: 27Sep2021, stop date: 27Sep2021, for Covid-19 Immunization, reaction(s): "sore arm", notes: DOSE 3 (BOOSTER), SINGLE , Vaccine location: Left arm, Lot number not provided.; Bnt162b2, start date: 02Mar2021, stop date: 02Mar2021, for Covid-19 Immunization, reaction(s): "sore arm", notes: DOSE 2, SINGLE , vaccine lot Number: EN6199, Vaccine location: Left arm; Bnt162b2, start date: 02Feb2021, stop date: 02Feb2021, for Covid-19 Immunization, reaction(s): "sore arm", notes: DOSE 1, SINGLE , vaccine lot Number: EN5318, Vaccine location: Left arm. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional Information: No reactions to vaccinations other than sore arm.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231836 same patient, different vaccine dose/event;US-PFIZER INC-202300231837 same patient, different vaccine dose/event;US-PFIZER INC-202300232004 same patient, different vaccine dose/event;
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 13Jun2023 to 18Jun2023.; Sender's Comments: Based on the available information, a possible contributory role of the suspect product cannot be completely excluded for reported events , Drug ineffective and COVID 19, due to a plausible temporal association.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 57 years for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 14Jun2023 to 18Jun2023. Patient experienced Rebound COVID.  No follow-up attempts are possible. No further information is expected.