Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: Bivalent dose administered to 7 patient after temperature excursion; No adverse event; Stored in the refrigerator at the time of the excursion with temperatures highest at 46.5 F for 15 minutes; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to 7 patient after temperature excursion), PRODUCT STORAGE ERROR (Stored in the refrigerator at the time of the excursion with temperatures highest at 46.5 F for 15 minutes), MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-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. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 04-May-2023. On 24-Oct-2022, the patient experienced PRODUCT STORAGE ERROR (Stored in the refrigerator at the time of the excursion with temperatures highest at 46.5 F for 15 minutes) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to 7 patient after temperature excursion) and NO ADVERSE EVENT (No adverse event). On 24-Oct-2022, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to 7 patient after temperature excursion), PRODUCT STORAGE ERROR (Stored in the refrigerator at the time of the excursion with temperatures highest at 46.5 F for 15 minutes) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Bivalent dose administered to 7 patient after temperature excursion), PRODUCT STORAGE ERROR (Stored in the refrigerator at the time of the excursion with temperatures highest at 46.5 F for 15 minutes) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy).    Treatment and concomitant medications were not reported.  It was reported that vaccine underwent a temperature excursion on Friday 21-Oct-2022. Vaccines were stored in refrigerator at the time of the excursion. Gestation weeks was unknown.  Individual vials size was 2.5mL and expiration date was 19-Nov-2022. Highest temperatures reached was 46.5 F for 15 minutes.  It was reported that vials appeared normal.  Company Comment: This spontaneous prospective pregnancy case concerns a 25-year-old female patient with no reported  medical history, who experienced the unexpected, non-serious  events of Maternal exposure during pregnancy and No adverse Event after receiving a dose mRNA-1273.222 Bivalent (Original and Omicron BA.4/BA.5) vaccine.  Last menstrual period  was not provided. The given estimated date of delivery would approximate gestational age of 13 weeks at the time of vaccine administration. Additionally, Product temperature excursion issue and Product storage error were noted since the patient received a vaccine that underwent temperature excursion (highest at 46.5 F) in the refrigerator for 15 minutes. 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.   This case was linked to US-MODERNATX, INC.-MOD-2022-664042, US-MODERNATX, INC.-MOD-2022-664045, US-MODERNATX, INC.-MOD-2022-664049, US-MODERNATX, INC.-MOD-2022-664054, US-MODERNATX, INC.-MOD-2022-664056, US-MODERNATX, INC.-MOD-2022-664064 (E2B Linked Report).; Sender's Comments: This spontaneous prospective pregnancy case concerns a 25-year-old female patient with no reported  medical history, who experienced the unexpected, non-serious  events of Maternal exposure during pregnancy and No adverse Event after receiving a dose mRNA-1273.222 Bivalent (Original and Omicron BA.4/BA.5) vaccine.  Last menstrual period  was not provided. The given estimated date of delivery would approximate gestational age of 13 weeks at the time of vaccine administration. Additionally, Product temperature excursion issue and Product storage error were noted since the patient received a vaccine that underwent temperature excursion (highest at 46.5 F) in the refrigerator for 15 minutes. 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. US-MODERNATX, INC.-MOD-2022-664042: US-MODERNATX, INC.-MOD-2022-664045: US-MODERNATX, INC.-MOD-2022-664049: US-MODERNATX, INC.-MOD-2022-664054: US-MODERNATX, INC.-MOD-2022-664056: US-MODERNATX, INC.-MOD-2022-664064: