Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse event; exposure via breast milk; drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (exposure via breast milk), MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031283) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer on 08-May-2022, Pfizer Bivalent on 07-Oct-2022, Pneumonia on 01-Sep-2023 and Flu on 01-Sep-2023. Past adverse reactions to the above products included No adverse reaction with Flu, Pfizer, Pfizer Bivalent and Pneumonia. Concurrent medical conditions included Type 2 diabetes mellitus, Hypothyroidism and Hypertension.    On 23-Sep-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. Last menstrual period and estimated date of delivery were not provided. On 23-Sep-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (exposure via breast milk) and MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 23-Sep-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (exposure via breast milk) and MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved. At the time of the report, NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for MATERNAL EXPOSURE DURING BREAST FEEDING (exposure via breast milk) and MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy).    Concomitant and treatment medications were not reported.  It was reported that HCP who administered a vaccine and administered it close to shoulder bone than it was suppose to be.  They need to call to see if the patient needs another vaccine or if it was fine the way it was administer it at that location. All of the medication went into the patient. HCP reports they used a prefilled syringe.  Company comment: This spontaneous case concerns a 56-year-old, female patient with medical history of type 2 diabetes mellitus, Hypothyroidism and Hypertension and no gynecological history reported, who experienced the unexpected non serious events of maternal exposure during pregnancy and maternal exposure during breast feeding. The events occurred on the same day after the third dose of SPIKEVAX 2023-2024 PFS. Date of patient's last menstrual period, expected delivery date, and gestational age at time of exposure were not provided. It was reported that HCP who administered a vaccine and administered it close to shoulder bone than it was suppose to be. No further information about the events was provided. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS is not affected by this report.