Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2); No adverse event; Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2)), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2)) 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)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Dec-2022, 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 05-Dec-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2)). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2)) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2)), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2)) 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 POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2)).    No concomitant medications were reported.  On 29-Nov-2022, temperature excursion occurred, and a dose was administered to the patient on 05-Dec-2022. No further information was provided.  No treatment medications were reported.  This case contains information for the first of two patients received vaccine on 05-Dec-2022 as described by the reporter.