chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was initially stored in the refrigerator on 16-May-2023, vaccine was expired on 09-Jun-2023 and administer on 11-Jun-2023.; No adverse event; 5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-Jun-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-Jun-2023), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 16-May-2023, vaccine was expired on 09-Jun-2023 and administer on 11-Jun-2023.) and NO ADVERSE EVENT (No adverse event) in a 1-decade-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. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jun-2023, 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 11-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-Jun-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 16-May-2023, vaccine was expired on 09-Jun-2023 and administer on 11-Jun-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-Jun-2023), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 16-May-2023, vaccine was expired on 09-Jun-2023 and administer on 11-Jun-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 (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11-Jun-2023) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 16-May-2023, vaccine was expired on 09-Jun-2023 and administer on 11-Jun-2023.).    Patient age was reported between 6 months to 5 years.  Concomitant product use was not provided by the reporter.  Vial size was reported as unknown blue Cap. Vial did not undergo temperature excursions.  Treatment information was not provided.  This case contains information about patient 3rd out of 5 child patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730079 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730079:Master Case(Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023) 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. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jun-2023, 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 11-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023).    Concomitant medication details not reported by the reporter. Vial did not undergo any temperature excursions. Vial was initially stored in the refrigerator on 16-MAY-2023. Treatment details was not reported by the reporter. The case contains information for patient 4 out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730079 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730079:Master case patient no. 01
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023) 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. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jun-2023, 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 11-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023).    Concomitant medication details not reported by the reporter. Vial did not undergo any temperature excursions. Vial was initially stored in the refrigerator on 16-MAY-2023. Treatment details was not reported by the reporter. This case contains information of patient 5th out of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-730079 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730079:(Patient 05 out of 05 patients)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; that 2 adult patients were administered an expired dose of the Moderna COVID-19 bivalent vaccine yesterday, 22JUN2023. The vaccine had expired on 18JUN2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (that 2 adult patients were administered an expired dose of the Moderna COVID-19 bivalent vaccine yesterday, 22JUN2023. The vaccine had expired on 18JUN2023) 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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-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 21-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (that 2 adult patients were administered an expired dose of the Moderna COVID-19 bivalent vaccine yesterday, 22JUN2023. The vaccine had expired on 18JUN2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (that 2 adult patients were administered an expired dose of the Moderna COVID-19 bivalent vaccine yesterday, 22JUN2023. The vaccine had expired on 18JUN2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (that 2 adult patients were administered an expired dose of the Moderna COVID-19 bivalent vaccine yesterday, 22JUN2023. The vaccine had expired on 18JUN2023).    Concomitant medication details not reported by the reporter. Vial size was reported as 5 ml. Vial was initially stored in the refrigerator was unknown. Vial did not undergo temperature excursion. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730172 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730172:Master Case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired Moderna Bivalent vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 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 EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Bivalent vaccine).    No concomitant medication was reported.  No treatment information was reported.     This case was linked to US-MODERNATX, INC.-MOD-2023-730166 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730166:Master Case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; adult patient was administered an expired dose of the Moderna COVID-19 bivalent vaccine on 21-Jun-2023.The vaccine had expired on 18-jun-2023.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (adult patient was administered an expired dose of the Moderna COVID-19 bivalent vaccine on 21-Jun-2023.The vaccine had expired on 18-jun-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)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-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 21-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (adult patient was administered an expired dose of the Moderna COVID-19 bivalent vaccine on 21-Jun-2023.The vaccine had expired on 18-jun-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (adult patient was administered an expired dose of the Moderna COVID-19 bivalent vaccine on 21-Jun-2023.The vaccine had expired on 18-jun-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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (adult patient was administered an expired dose of the Moderna COVID-19 bivalent vaccine on 21-Jun-2023.The vaccine had expired on 18-jun-2023.).    No concomitant medication was reported. The dosage text of the suspect was reported as unknown. It was reported that 2 adult patients were administered an expired dose of the Moderna COVID-19 bivalent vaccine, 21-Jun-2023. The vaccine had expired on 18-Jun-2023. The HCP was looking for guidance for these patients on whether they need to be revaccinated or not. Vial size was reported as 5 ml. Vial was initially stored in the refrigerator was unknown. Vial did not undergo temperature excursion. No treatment medication was reported.  This case contains information about patient 2nd  out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730167 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730167:Master Case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: We gave 4 doses of expired Moderna Bivalent vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Bivalent vaccine).    At the time of report patient initial and date of birth was not known by the reporter.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 3rd out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730166 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730166:Master Case - Patient 1 Case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: We gave 4 doses of expired Moderna Bivalent vaccine; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 4 doses of expired Moderna Bivalent vaccine).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided. This case is reported for patient 4 out of 4 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730166 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730166:Master Case - Patient 1 Case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: We gave 3 doses of expired Moderna bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) 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 (We gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna bivalent).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case contains information about patient 3rd out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730168 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730168:Master Case(Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: we gave 3 doses of expired Moderna bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (we gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) 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 (we gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (we gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (we gave 3 doses of expired Moderna bivalent).    Concomitant product use was not provided by the reporter. Treatment information was not provided. This case contains information about patient 2nd out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730168 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730168:Master case patient no. 01
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received second dose on 04-Feb-2021 and third dose on 21-Aug-2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 04-Feb-2021 and third dose on 21-Aug-2021) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no acute illness at the time of vaccination and upto one month before.  Concurrent medical conditions included Hypertension, Coronary artery disease, Hyperlipidemia and Enlarged prostate. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Coronary artery disease, TAMSULOSIN HCL for Enlarged prostate, ATORVASTATIN CALCIUM (LIPITOR) for Hyperlipidemia, LOSARTAN POTASSIUM for Hypertension, PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 04-Feb-2021 and third dose on 21-Aug-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 04-Feb-2021 and third dose on 21-Aug-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose on 04-Feb-2021 and third dose on 21-Aug-2021).    Treatment information was not reported.   This case was linked to MOD-2023-729605 (Patient Link).
Sex: M
Vaccine: COVID19-2
Symptoms: Facial discomfort
Clinical narrative: he got this motion in his face; This spontaneous case was reported by a patient family member or friend and describes the occurrence of FACIAL DISCOMFORT (he got this motion in his face) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 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 FACIAL DISCOMFORT (he got this motion in his face). At the time of the report, FACIAL DISCOMFORT (he got this motion in his face) outcome was unknown.            No concomitant medications were reported.   It was reported that the patient got the Moderna COVID shot, and was refusing to receive it at first. As soon as the patient got the Moderna vaccine, he got the motion in his face. It stretched out or something.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730200 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730200:Case for mother (same reporter)
Age: 5.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; The nurse shared that a patient received 0.2 from the pink cap vial which was the wrong dose and should have received 0.25 from the blue cap vial.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (The nurse shared that a patient received 0.2 from the pink cap vial which was the wrong dose and should have received 0.25 from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Quadracel  Past adverse reactions to the above products included No adverse event with Quadracel. Concurrent medical conditions included Autistic disorder.    On 12-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 12-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (The nurse shared that a patient received 0.2 from the pink cap vial which was the wrong dose and should have received 0.25 from the blue cap vial.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The nurse shared that a patient received 0.2 from the pink cap vial which was the wrong dose and should have received 0.25 from the blue cap vial.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The nurse shared that a patient received 0.2 from the pink cap vial which was the wrong dose and should have received 0.25 from the blue cap vial.).    Patient wasn't taking any medication. Patient had received another vaccine within 4 weeks of COVID-19 vaccination. Patient didn't report any adverse events. No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2023: Added additional reporter, updated patient demographics, suspect drug information and I narrative.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: We gave 3 doses of expired Moderna bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 069H22A) 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 (We gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna bivalent).    No concomitant information was reported. No treatment information was provided. This case is reported for patient 1 out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-730186, US-MODERNATX, INC.-MOD-2023-730183 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730183:(Out of 02 Paitents this case for Patient no. 03) US-MODERNATX, INC.-MOD-2023-730186:(Out of 03 Paitents this case for Patient no. 03)
Sex: F
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse event; she got all 3 shots bivalent, and she already had received the booster for 2021 and got it again yesterday.; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (she got all 3 shots bivalent, and she already had received the booster for 2021 and got it again yesterday.) and NO ADVERSE EVENT (No adverse event) 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. 061F22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 Vaccine (Booster) in 2021. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 Vaccine.    On 20-Jun-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 20-Jun-2023, the patient experienced EXTRA DOSE ADMINISTERED (she got all 3 shots bivalent, and she already had received the booster for 2021 and got it again yesterday.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (she got all 3 shots bivalent, and she already had received the booster for 2021 and got it again yesterday.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (she got all 3 shots bivalent, and she already had received the booster for 2021 and got it again yesterday.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that patient had 3 shots bivalent, and she alreadyhad received the booster for 2021 and got it again yesterday. It was reported that patient gave her son card instead of her card. No treatment information was provided.
Age: 1.75
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: More than 3 months in between the first two doses of a Moderna Covid-19 vaccine.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 3 months in between the first two doses of a Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) in a child female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 3 months in between the first two doses of a Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 3 months in between the first two doses of a Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 3 months in between the first two doses of a Moderna Covid-19 vaccine.).    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; As per narrative patient took 2 Bivalent booster doses; A single additional age appropriate dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine;; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (As per narrative patient took 2 Bivalent booster doses), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A single additional age appropriate dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine;) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. AS7145B and 059F22A) for COVID-19 prophylaxis.     The patient's past medical history included Cancer. Concurrent medical conditions included Immunocompromised.   On 12-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Dec-2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (As per narrative patient took 2 Bivalent booster doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A single additional age appropriate dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine;). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (As per narrative patient took 2 Bivalent booster doses), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A single additional age appropriate dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 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 EXTRA DOSE ADMINISTERED (As per narrative patient took 2 Bivalent booster doses) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A single additional age appropriate dose of Moderna COVID-19 Vaccine, Bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine;).    No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-729996 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling hot, Loss of personal independence in daily activities, Rash
Clinical narrative: she had a Moderna shot she broke out in a bad rash and got very hot and could not even drive; she had a Moderna shot she broke out in a bad rash and got very hot and could not even drive; she had a Moderna shot she broke out in a bad rash and got very hot and could not even drive; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (she had a Moderna shot she broke out in a bad rash and got very hot and could not even drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she had a Moderna shot she broke out in a bad rash and got very hot and could not even drive) and RASH (she had a Moderna shot she broke out in a bad rash and got very hot and could not even drive) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 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 FEELING HOT (she had a Moderna shot she broke out in a bad rash and got very hot and could not even drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she had a Moderna shot she broke out in a bad rash and got very hot and could not even drive) and RASH (she had a Moderna shot she broke out in a bad rash and got very hot and could not even drive). At the time of the report, FEELING HOT (she had a Moderna shot she broke out in a bad rash and got very hot and could not even drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (she had a Moderna shot she broke out in a bad rash and got very hot and could not even drive) and RASH (she had a Moderna shot she broke out in a bad rash and got very hot and could not even drive) outcome was unknown.            Patient was age was reported as between the ages of 20 and 30.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  It was reported that pharmacist told the reporter about Six months ago, she had a female patient come into the pharmacy had the reaction when patient last time took the moderna shot. Patient did not take the moderna shot from the same pharmacy.  Treatment information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patients received 4 doses of expired Moderna Bivalent vaccine; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received 4 doses of expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received 4 doses of expired Moderna Bivalent vaccine) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received 4 doses of expired 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients received 4 doses of expired Moderna Bivalent vaccine).    No concomitant information was reported. Suspect product dosage text was reported as unknown. No treatment information was provided. The case contains information for patient 1 out of 4.   This case was linked to US-MODERNATX, INC.-MOD-2023-730170, US-MODERNATX, INC.-MOD-2023-730173, US-MODERNATX, INC.-MOD-2023-730178 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730178:Patient 4 Case US-MODERNATX, INC.-MOD-2023-730173:Patient 3 Case US-MODERNATX, INC.-MOD-2023-730170:Patient 2 Case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023) 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. AS7170B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jun-2023, 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 11-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 pediatric patients (6M-5Y) received expired first dose Moderna Bivalent COVID-19 vaccine on 11JUN2023).    Concomitant medication details not reported by the reporter. Vial did not undergo any temperature excursions. Vial was initially stored in the refrigerator on 16-MAY-2023. Treatment details was not reported by the reporter. This case contains information about 1st patient out of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-730080, US-MODERNATX, INC.-MOD-2023-730081, US-MODERNATX, INC.-MOD-2023-730083, US-MODERNATX, INC.-MOD-2023-730114 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730083:(Patient 04 out of 05 patients) US-MODERNATX, INC.-MOD-2023-730080:(Patient 02 out of 05 patients) US-MODERNATX, INC.-MOD-2023-730081:(Patient 03 out of 05 patients) US-MODERNATX, INC.-MOD-2023-730114:(Patient 05 out of 05 patients)
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It is unknown if the patient experienced any additional symptoms/events. Treatment information was not reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19-2
Symptoms: Bone marrow transplant
Clinical narrative: They are calling about a patient asking about re-vaccination for the COVID-19 vaccine after a bone marrow transplant about a week ago.; This spontaneous case was reported by a consumer and describes the occurrence of BONE MARROW TRANSPLANT (They are calling about a patient asking about re-vaccination for the COVID-19 vaccine after a bone marrow transplant about a week ago.) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient did not have the Medical history or condition.     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. In 2023, the patient experienced BONE MARROW TRANSPLANT (They are calling about a patient asking about re-vaccination for the COVID-19 vaccine after a bone marrow transplant about a week ago.). At the time of the report, BONE MARROW TRANSPLANT (They are calling about a patient asking about re-vaccination for the COVID-19 vaccine after a bone marrow transplant about a week ago.) outcome was unknown.        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.   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Dosage text was reported as unknown. Treatment details was not reported by the reporter.
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by 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 33-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 042H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (009C21A, Dose 1) on 22-Apr-2021, COVID-19 VACCINE (022C21A, Dose 2) on 20-May-2021, COVID-19 VACCINE (026D21A and Dose 3) on 03-Dec-2021. Past adverse reactions to the above products included No adverse effect with COVID-19 VACCINE; and No adverse event with COVID-19 VACCINE and COVID-19 VACCINE.    On 20-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 20-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    Concomitant medication was not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2023: Live Follow up received and updated patient DOB updated, added Relevant Past Drug History.