chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Breast cancer, Cardiac disorder
Clinical narrative: A fib; Breast cancer; Heart problem; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (A fib) and BREAST CANCER (Breast cancer) 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. The occurrence of additional non-serious events is detailed below.     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 ATRIAL FIBRILLATION (A fib) (seriousness criterion medically significant), BREAST CANCER (Breast cancer) (seriousness criterion medically significant) and CARDIAC DISORDER (Heart problem). At the time of the report, ATRIAL FIBRILLATION (A fib), BREAST CANCER (Breast cancer) and CARDIAC DISORDER (Heart problem) outcome was unknown.            No concomitant medication information was provided. It was reported that several patient had heart problems. breast cancer and a fib. No treatment medications were provided  Company Comment:  This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious  (medically significant) adverse event of special interest Atrial fibrillation and event of Breast cancer in the context of having received a dose of mRNA-1273.222 (Bivalent Original and Omicron BA.4/BA.5) vaccine.  Onset latency could not be assessed as both the dates of vaccine administration and onset of events were not detailed. Treatment, clinical course, and pertinent investigations were not disclosed. Outcome of the events was noted to be unknown. No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273.222 (Bivalent Original and Omicron BA.4/BA.5) vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no reported medical history, who experienced the unexpected, serious  (medically significant) adverse event of special interest Atrial fibrillation and event of Breast cancer in the context of having received a dose of mRNA-1273.222 (Bivalent Original and Omicron BA.4/BA.5) vaccine.  Onset latency could not be assessed as both the dates of vaccine administration and onset of events were not detailed. Treatment, clinical course, and pertinent investigations were not disclosed. Outcome of the events was noted to be unknown. No information on any other doses of COVID-19 vaccination was provided. The benefit-risk relationship of mRNA-1273.222 (Bivalent Original and Omicron BA.4/BA.5) vaccine is not affected by this report.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 04-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml).    No concomitant medication information was provided.  Patient received Moderna bivalent booster dose.  No treatment medication were provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; patient have been given 0.25 mL of Moderna Bivalent booster vaccine instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (patient have been given 0.25 mL of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 04-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient have been given 0.25 mL of Moderna Bivalent booster vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient have been given 0.25 mL of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient have been given 0.25 mL of Moderna Bivalent booster vaccine instead of 0.5 ml).    No concomitant medication information was reported. No treatment information was reported.  The reporter wanted for suggestion about whether these affected patients need to receive another 0.25mL dose or not.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; 0.25ml dose administered instead of 0.5ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (0.25ml dose administered instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 11-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (0.25ml dose administered instead of 0.5ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (0.25ml dose administered instead of 0.5ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (0.25ml dose administered instead of 0.5ml).    No concomitant product was reported.  This case contains information for the 4th of the 14 patients described by the reporter.  No treatment information was reported.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 11-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml).    Patient received Moderna bivalent booster dose.  No concomitant medication information was provided. No treatment medication were provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 11-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml).    No concomitant medication information was provided.  Patient received Moderna bivalent booster dose.  No treatment medication were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 11-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml).    Patient received Moderna bivalent booster dose.  No concomitant medication information was provided. No treatment medication were provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 11-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml).    No concomitant medications were reported.  Patient received Moderna bivalent booster dose.  No treatment medications were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 18-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patients were administered 0.25 ml of Moderna Bivalent booster vaccine instead of 0.5 ml).    Patient received 0.25 mL of Moderna bivalent booster dose.  No concomitant medication information was provided. No treatment medication were provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; 0.25ml dose administered instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 18-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (0.25ml dose administered instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (0.25ml dose administered instead of 0.5mL).    No concomitant products reported.  It was reported that it had been brought to attention that the patient had been given 0.25mL of Moderna Bivalent booster vaccine. Asked for advise if the 0.25mL dose was enough coverage for the patient. Questioned if the patient need to receive another 0.25mL dose.  This case was for one of the patient among the 14 patients who received 0.25mL of Moderna Bivalent booster vaccine.   No treatment products reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Medication error, 0.25ml dose administered instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 18-Oct-2022, the patient experienced UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL).    No concomitant products reported.  It was reported that it had been brought to attention that the patient had been given 0.25mL of Moderna Bivalent booster vaccine. Asked for advise if the 0.25mL dose was enough coverage for the patient. Questioned if the patient need to receive another 0.25mL dose.  This case was for one of the patient among the 14 patients who received 0.25mL of Moderna Bivalent booster vaccine.   No treatment products reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Medication error, 0.25ml dose administered instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 18-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL).    No concomitant products reported.  It was reported that it had been brought to attention that the patient had been given 0.25mL of Moderna Bivalent booster vaccine. Asked for advise if the 0.25mL dose was enough coverage for the patient. Questioned if the patient need to receive another 0.25mL dose.  This case was for one of the patient among the 14 patients who received 0.25mL of Moderna Bivalent vaccine.   No treatment products reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Medication error, 0.25ml dose administered instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL).    No concomitant products reported.  It was reported that it had been brought to attention that the patient had been given 0.25mL of Moderna Bivalent booster vaccine. Asked for advise if the 0.25mL dose was enough coverage for the patient. Questioned if the patient need to receive another 0.25mL dose.  This case was for one of the patient among the 14 patients who received 0.25mL of Moderna Bivalent booster vaccine.   No treatment products reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Medication error, 0.25ml dose administered instead of 0.5mL; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Medication error, 0.25ml dose administered instead of 0.5mL).    No concomitant products reported.  It was reported that it had been brought to attention that the patient had been given 0.25mL of Moderna Bivalent booster vaccine. Asked for advise if the 0.25mL dose was enough coverage for the patient. Questioned if the patient need to receive another 0.25mL dose.  This case was for one of the patient among the 14 patients who received 0.25mL of Moderna Bivalent booster vaccine.   No treatment products reported.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Moderna Dose 1 24-FEB-2021 and Moderna dose 2 7-APR-2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 24-FEB-2021 and Moderna dose 2 7-APR-2021) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 027B21A) for COVID-19 prophylaxis.     The patient's past medical history included Obesity. Concurrent medical conditions included Hypertension.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 24-FEB-2021 and Moderna dose 2 7-APR-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 (Moderna Dose 1 24-FEB-2021 and Moderna dose 2 7-APR-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Moderna vaccine dose 3 given on 11 Nov 2021 with Batch/Lot No: 067F21A and location of injection was left arm. Moderna vaccine dose 4 given on 10 May 2022 with Batch/Lot No: 049L21A and location of injection was left arm. Moderna vaccine dose 4 given on 07 Sep 2022 with Batch/Lot No: AS7140C and location of injection was left arm. Pfizer vaccine was used for treatment of covid 19 on 15-Oct-2022 and had event Symptomatic rebound with positive antigen test result on 24 Oct 2022 with outcome recovering/resolving. The concomitant medication Pharma was taken by 1-Jan-2022 till 24-Oct-2022.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect dose administered, No adverse event
Clinical narrative: No Adverse Event; 3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022; 3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022), INCORRECT DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022) and NO ADVERSE EVENT (No Adverse Event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 063B22A, 025D21A, 016B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 28-Sep-2022, the patient experienced EXTRA DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022) and INCORRECT DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXTRA DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022), INCORRECT DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXTRA DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022) and INCORRECT DOSE ADMINISTERED (3rd dose given for non-immunocompromised patient/ extra fourth dose on 28Sep2022).    No concomitant medications were reported. The patient was given an extra fourth dose on 28-Sep-2022.  No treatment medications were reported.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; received Moderna original 0.5ml doses instead of the bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster).    No concomitant medications were reported. No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2022: Follow up received wherein patient's DOB, initials, gender and age added.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Feeling abnormal
Clinical narrative: Patient felt funny; Patient energy was kind of low after the vaccine"; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient felt funny) and ASTHENIA (Patient energy was kind of low after the vaccine") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01120A (?)) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension, Diabetes and Drug allergy (opioids). Concomitant products included HYDROCHLOROTHIAZIDE for Hypertension and Diabetes.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Patient felt funny) and ASTHENIA (Patient energy was kind of low after the vaccine"). At the time of the report, FEELING ABNORMAL (Patient felt funny) and ASTHENIA (Patient energy was kind of low after the vaccine") outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment details was not reported by the reporter.   This case was linked to MOD-2022-664536 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Feeling abnormal, Mobility decreased
Clinical narrative: Patient felt funny; Patient energy was kind of low after the vaccine"; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient felt funny) and ASTHENIA (Patient energy was kind of low after the vaccine") in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01120A (?)) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension, Diabetes and Drug allergy (opioids). Concomitant products included HYDROCHLOROTHIAZIDE for Hypertension and Diabetes.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Patient felt funny) and ASTHENIA (Patient energy was kind of low after the vaccine"). At the time of the report, FEELING ABNORMAL (Patient felt funny) and ASTHENIA (Patient energy was kind of low after the vaccine") outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment details was not reported by the reporter.   This case was linked to MOD-2022-664536 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; received Moderna original 0.5ml doses instead of the bivalent booster; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (received Moderna original 0.5ml doses instead of the bivalent booster).    No concomitant medications were reported. No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2022: Follow up received wherein patient's DOB, gender, initials and age added.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: No adverse event; Patient received monovalent Moderna COVID19 vaccine as a booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent Moderna COVID19 vaccine as a booster) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer COVID19 vaccine (1st dose Pfizer COVID19 vaccine 30Dec2020) on 30-Dec-2020, Pfizer COVID19 vaccine (2nd dose Pfizer COVID19 vaccine 20Jan 2021) on 20-Jan-2021 and Pfizer COVID19 vaccine (3rd dose Pfizer COVID19 vaccine11Oct2021) on 11-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID19 vaccine, Pfizer COVID19 vaccine and Pfizer COVID19 vaccine.   On 26-Oct-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent Moderna COVID19 vaccine as a booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent Moderna COVID19 vaccine as a booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT PRODUCT FORMULATION ADMINISTERED (Patient received monovalent Moderna COVID19 vaccine as a booster).    No concomitant information provided No treatment information provided
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Pain
Clinical narrative: Moderna shot made me sick; terrible aches and pains; flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Moderna shot made me sick), PAIN (terrible aches and pains) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 68-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)) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Johnson n Johnson Covid vaccine (at beginning of pandemic. No negative effects at all.). Past adverse reactions to the above products included No adverse event with Johnson n Johnson Covid vaccine.    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 ILLNESS (Moderna shot made me sick), PAIN (terrible aches and pains) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, ILLNESS (Moderna shot made me sick), PAIN (terrible aches and pains) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved.            No concomitant medication was reported.  Patient was in good medical shape.  Reportedly, patient had all the symptoms for 24 hours. Pfizer shot did the same thing.  No other vaccines such as flu has ever made patient sick.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: has Covid for the second time; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (has Covid for the second time) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (has Covid for the second time). At the time of the report, COVID-19 (has Covid for the second time) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  Caller said her daughter has Covid for the second time and she does not know which vaccine she had and if it was Moderna or not.  No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product label confusion
Clinical narrative: He reported that the vial label is confusing; No adverse event; Received Monovalent booster instead of Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster). On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster) and PRODUCT LABEL CONFUSION (He reported that the vial label is confusing).    No concomitant medication was reported.  Reporter had a Dark Blue Cap and a label with purple border. On the vial label it stated, Booster dose only. Reporter stated that the vial label was confusing, so 5 adult Patients received Monovalent booster instead of Bivalent booster of Moderna COVID-19 vaccine.  No treatment information was provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product label confusion
Clinical narrative: He reported that the vial label is confusing; No adverse event; Received Monovalent booster instead of Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster). On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster) and PRODUCT LABEL CONFUSION (He reported that the vial label is confusing).    No concomitant medication was reported.  Reporter had a Dark Blue Cap and a label with purple border. On the vial label it stated, Booster dose only. Reporter stated that the vial label was confusing, so 5 adult Patients received Monovalent booster instead of Bivalent booster of Moderna COVID-19 vaccine.  No treatment information was provided.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event, Product label confusion
Clinical narrative: He reported that the vial label is confusing; No adverse event; Received Monovalent booster instead of Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster) and NO ADVERSE EVENT (No adverse event). On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (He reported that the vial label is confusing). At the time of the report, INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster), PRODUCT LABEL CONFUSION (He reported that the vial label is confusing) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INCORRECT DOSE ADMINISTERED (Received Monovalent booster instead of Bivalent booster) and PRODUCT LABEL CONFUSION (He reported that the vial label is confusing).    No concomitant medication was reported.  Reporter had a Dark Blue Cap and a label with purple border. On the vial label it stated, Booster dose only. Reporter stated that the vial label was confusing, so 5 adult Patients received Monovalent booster instead of Bivalent booster of Moderna COVID-19 vaccine.  No treatment information was provided.