Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | IM / LA |
| RVX | ROTAVIRUS (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | MD5461 | IM / LA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 3052549 | IM / LA |
Mild soreness in arm after injection; mild fatigue for 24 hours; Patient received the vaccine while 35 weeks + 6 days pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Mild soreness in arm after injection), FATIGUE (mild fatigue for 24 hours) and MATERNAL EXPOSURE DURING PREGNANCY (Patient received the vaccine while 35 weeks + 6 days pregnant) in a 32-year-old female patient (gravida 2) who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052549) for COVID-19 prophylaxis. Co-suspect products included non-company products RSV vaccine for an unknown indication and Influenza vaccine (Flu) for an unknown indication. The patient's past medical history included Pregnancy (Patient had 1 previous pregnancy and outcome was reported as spontaneous termination.) on 31-Oct-2024. On 28-Aug-2025, the patient received dose of Influenza vaccine (Flu) (Intramuscular use) 1 dosage form. On 05-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. On 07-Sep-2025, the patient received dose of RSV vaccine (Intramuscular use) 1 dosage form. The patient's last menstrual period was on 28-Dec-2024 and the estimated date of delivery was 04-Oct-2025. On 05-Sep-2025, the patient experienced PAIN IN EXTREMITY (Mild soreness in arm after injection), FATIGUE (mild fatigue for 24 hours) and MATERNAL EXPOSURE DURING PREGNANCY (Patient received the vaccine while 35 weeks + 6 days pregnant). The patient received mRNA-1273.251 (Spikevax LP.8.1 PFS) beginning around the thirty-fifth week of the pregnancy, RSV vaccine beginning around the thirty-sixth week of the pregnancy and Influenza vaccine (Flu) beginning around the thirty-fourth week of the pregnancy. On 05-Sep-2025, MATERNAL EXPOSURE DURING PREGNANCY (Patient received the vaccine while 35 weeks + 6 days pregnant) had resolved. On 06-Sep-2025, PAIN IN EXTREMITY (Mild soreness in arm after injection) and FATIGUE (mild fatigue for 24 hours) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2025, Pregnancy test: Positive. Concomitant medication was not reported. Patient did not have allergies to medications, food and other products. Prenatal case has been established. She did not have maternal history of infertility. Patient received the vaccine while 35 weeks + 6 days pregnant. She had mild soreness in arm after injection and mild fatigue for 24 hours but no other symptoms. The patient did not experience any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available. Treatment information was not reported. Most recent FOLLOW-UP information incorporated above includes: On 11-Sep-2025: Live significant follow-up received on 11-sep-2025: Medical history and patient details and pregnancy details updated; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Pregnancy (Patient had 1 previous pregnancy and outcome was reported as spontaneous termination.)
Test Date: 20250123; Test Name: pregnancy test; Test Result: Positive