Sex: U
Vaccine: COVID19-2
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml) and NO ADVERSE EVENT (No adverse event) in an elderly 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. 067H22A) for COVID-19 prophylaxis.     It was unknown if the patient had any acute illnesses at the time of vaccination and up to one month before. It was also unknown if the patient had any chronic or long-standing health conditions.    On 10-May-2023, 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 12-May-2023, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 12-May-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10-May-2023, 27 patients received 0.25 ml of the Moderna bivalent vaccine and later on 12-May-2023, 18 pts received an additional 0.25 ml).    This case corresponds to 20th patient out of 27 patients as described by the reporter.  The age of the patient was reported as over 65 years.  Concomitant medication of the patient was not reported as it was unknown if the patient was taking any prescriptions, over-the-counter medications, dietary supplements, or herbal remedies at time of vaccination or at the time of the adverse event.  It was reported that on 10-May-2023, 27 patients had received 0.25 ml of bivalent booster instead of 0.5 ml. On 11-May-2023, the patients were contacted and on 12-May-2023, 18 patients received additional 0.25 ml. Vaccine body site was reported as deltoid.  The reporter did not report any other adverse reactions.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case