Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product label issue
Clinical narrative: he is not sure if this is package change or if these are considered bivalent , or if these are the older boosters, Carton label - confusing/ misleading; The pharmacist explains that previously, the packaging would say bivalent on the boxes and vials. But this says booster doses only.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT LABEL ISSUE (he is not sure if this is package change or if these are considered bivalent , or if these are the older boosters, Carton label - confusing/ misleading), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist explains that previously, the packaging would say bivalent on the boxes and vials. But this says booster doses only.) 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. 018C22A) 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 PRODUCT LABEL ISSUE (he is not sure if this is package change or if these are considered bivalent , or if these are the older boosters, Carton label - confusing/ misleading), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist explains that previously, the packaging would say bivalent on the boxes and vials. But this NDC says booster doses only.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT LABEL ISSUE (he is not sure if this is package change or if these are considered bivalent , or if these are the older boosters, Carton label - confusing/ misleading), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist explains that previously, the packaging would say bivalent on the boxes and vials. But this says booster doses only.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT LABEL ISSUE (he is not sure if this is package change or if these are considered bivalent , or if these are the older boosters, Carton label - confusing/ misleading) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist explains that previously, the packaging would say bivalent on the boxes and vials. But this NDC says booster doses only.).    No concomitant product use was reported.  The pharmacist reported that previously, the packaging would say bivalent on the boxes and vials. But at the time of report says booster doses only. Pharmacist was not sure if the package change or if that was considered bivalent, or if that was the older boosters.  No treatment information was provided..