Received Oct 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 8146367 | IM |
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | UNK | MF2162 | IM |
chills; muscle aches; drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (muscle aches) and MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) in a 36-year-old female patient (gravida 3, para 2) who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 8146367) for COVID-19 prophylaxis. Co-suspect product included non-company product RSV vaccine prot. subunit PreF 2v (Abrysvo) for an unknown indication. asthma, eczema Patient was diagnosed with Covid 19. The patient's past medical history included COVID-19 on 15-Aug-2024, Pregnancy (Breech delivery, C-section, Live full-term birth) on XX-Aug-2019, Pregnancy (Live full-term birth) on XX-Oct-2021, Alcohol use (2 drinks per week prior to pregnancy) on 20-Feb-2021 and C-section (Breech delivery, c section) on XX-Aug-2019. Concurrent medical conditions included Asthma since 1994 and Eczema. On 27-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form and dose of RSV vaccine prot. subunit PreF 2v (Abrysvo) (Intramuscular use) 1 dosage form. The patient's last menstrual period was on 21-Jan-2025 and the estimated date of delivery was 28-Oct-2025. On 27-Sep-2025, the patient experienced CHILLS (chills), MYALGIA (muscle aches) and MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy). The patient received mRNA-1273.251 (Spikevax LP.8.1 PFS) beginning around the thirty-fifth week of the pregnancy and RSV vaccine prot. subunit PreF 2v (Abrysvo) beginning around the thirty-fifth week of the pregnancy. The patient was treated with Paracetamol (Tylenol) on 27-Sep-2025 at an unspecified dose and frequency. On 27-Sep-2025, MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved. On 28-Sep-2025, CHILLS (chills) and MYALGIA (muscle aches) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2025, Pregnancy test: Positive. No concomitant medications were provided. It was reported that there was no maternal history of infertility. The patient had no allergies to medications, food, and other products. The night of vaccination, patient had chills and muscle aches and took tylenol. This case was linked to US-MODERNATX, INC.-MOD-2022-607594 (E2B Linked Report).; Reporter's Comments: Company comment: The benefit-risk relationship of product is not affected by this report.; Sender's Comments: US-MODERNATX, INC.-MOD-2022-607594:same patient diffrent suspect
Asthma; Eczema
Medical History/Concurrent Conditions: Alcohol use (2 drinks per week prior to pregnancy); C-section (Breech delivery, c section); COVID-19; Pregnancy (Live full-term birth); Pregnancy (Breech delivery, C-section, Live full-term birth); Comments: asthma, eczema Patient was diagnosed with Covid 19
Test Date: 202502; Test Name: Pregnancy Test; Test Result: Positive