Age: 29.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 /Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours; Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.HCP reported that patient received the vaccines on 15-Dec-2022 and then following that the vaccines were marked not to use; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 /Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours), POOR QUALITY PRODUCT ADMINISTERED (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.HCP reported that patient received the vaccines on 15-Dec-2022 and then following that the vaccines were marked not to use) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-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 15-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 /Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours) and POOR QUALITY PRODUCT ADMINISTERED (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.HCP reported that patient received the vaccines on 15-Dec-2022 and then following that the vaccines were marked not to use). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 /Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours), POOR QUALITY PRODUCT ADMINISTERED (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.HCP reported that patient received the vaccines on 15-Dec-2022 and then following that the vaccines were marked not to use) 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 TEMPERATURE EXCURSION ISSUE (HCP reports they gave 16 doses of the vaccines between the 15Dec2022 and the 21Dec2022 /Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours) and POOR QUALITY PRODUCT ADMINISTERED (Excursion took place 15Dec2022 through 27Dec2022 Maximum temperature reached: 46.5F Excursion cumulative duration: 19.3 hours.HCP reported that patient received the vaccines on 15-Dec-2022 and then following that the vaccines were marked not to use).    No concomitant medications were reported. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that excursion took place from 15-Dec-2022 to 27-Dec-2022 and maximum temperature reached was 46.5F and Excursion cumulative duration was 19.3 hrs. First time excursion was started on 15-Dec-2022 and HCP reported to give 16 doses of vaccine between 15-Dec-2022 to 21-Dec-2022 and then these vaccines were marked for not use. HCP mentioned No side effects were reported to them. All the patient received vaccine at pharmacy. No treatment information was reported.