Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Product storage error, Product temperature excursion issue
Clinical narrative: Maternal exposure during pregnancy; 1 booster dose given after temperature excursion; 1 booster dose given after temperature excursion; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (1 booster dose given after temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (1 booster dose given after temperature excursion) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A and 058E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 20-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced PRODUCT STORAGE ERROR (1 booster dose given after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (1 booster dose given after temperature excursion). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). At the time of the report, PRODUCT STORAGE ERROR (1 booster dose given after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (1 booster dose given after temperature excursion) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment  medications was reported. No known drug allergies reported.  No adverse event reported by patient. Moderna booster dose, 50 micrograms per 0.25 milliliters, administered post refrigerator temperature excursion, 30 minutes out of range, then back in range for the remainder of medication viability.  Company Comment:  This spontaneous case concerns a 57-year-old, pregnant patient with no medical history reported who received the booster doses of vaccination with mRNA-1273 at unknown age of gestation (Maternal exposure during pregnancy). Product storage error and Product temperature excursion issue were also reported in the case. The outcome of pregnancy is pending at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-583964 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jun-2022: Significant Follow-up received on 06-Jun-2022 where reporter's details, patient information, pregnancy information, suspect dose information and I narrative were updated.; Sender's Comments: This spontaneous case concerns a 57-year-old, pregnant patient with no medical history reported who received the booster doses of vaccination with mRNA-1273 at unknown age of gestation (Maternal exposure during pregnancy). Product storage error and Product temperature excursion issue were also reported in the case. The outcome of pregnancy is pending at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.