Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 8146367 | OT |
| RSV | RSV (ABRYSVO) | PFIZER\WYETH | 1 | MF2162 | OT |
chills; muscle aches; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-789796 (Moderna). A female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 27Sep2025 as dose 1, single (Lot number: MF2162) intramuscular for maternal immunisation; elasomeran (SPIKEVAX), on 27Sep2025 as dose number unknown, single (Lot number: 8146367) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Asthma", start date: 1994 (ongoing); "Eczema" (ongoing); "COVID-19", start date: 15Aug2024 (not ongoing); "caesarean section", start date: 28Aug2019, stop date: 28Aug2019, notes: Breech delivery, C-section; "Pregnancy", stop date: 30Oct2021, notes: Live full-term birth; "Alcohol use", stop date: 20Feb2021, notes: 2 drinks per week prior to pregnancy; "Pregnancy", stop date: 28Aug2019, notes: Breech delivery, C-section, Live full-term birth. Date of last menstrual period: 21Jan2025. The patient was 35 weeks pregnant at the time of exposure to rsv vaccine prot.subunit pref 2v, elasomeran. The patient was 35 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 28Oct2025. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 27Sep2025, outcome "recovered" (28Sep2025); MYALGIA (non-serious) with onset 27Sep2025, outcome "recovered" (28Sep2025), described as "muscle aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, myalgia. Additional information: 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 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 15Aug2024, Pregnancy (Breech delivery, C-section, Live full-term birth) on 28Aug2019, Pregnancy (Live full-term birth) on 30Oct2021, Alcohol use (2 drinks per week prior to pregnancy) on 20Feb2021 and C-section (Breech delivery, c section) on 28Aug2019. Concurrent medical conditions included Asthma since 1994 and Eczema. On 27Sep2025, 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 21Jan2025 and the estimated date of delivery was 28Oct2025. On 27Sep2025, 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 27Sep2025 at an unspecified dose and frequency. On 27Sep2025, MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved. On 28Sep2025, 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. Case Comment/Sender Comment: Company comment: The benefit-risk relationship of product is not affected by this report. No follow-up attempts are possible. No further information is expected.
Asthma; Eczema
Medical History/Concurrent Conditions: Alcohol use (2 drinks per week prior to pregnancy); Caesarean section (Breech delivery, C-section); COVID-19; Pregnancy (Live full-term birth); Pregnancy (Breech delivery, C-section, Live full-term birth)
Test Date: 202502; Test Name: Pregnancy test; Test Result: Positive