Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
teeth hurting; arm soreness; headache; Drug exposure during pregnancy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Sep-2025 and was forwarded to Moderna on 23-Sep-2025. This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of TOOTHACHE (teeth hurting), PAIN IN EXTREMITY (arm soreness), HEADACHE (headache) and MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) in a 31-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) for COVID-19 prophylaxis. No Medical History information was reported. On 21-Sep-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 21-Sep-2025, the patient experienced TOOTHACHE (teeth hurting), PAIN IN EXTREMITY (arm soreness), HEADACHE (headache) and MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). The patient was treated with Paracetamol (Tylenol) at an unspecified dose and frequency. On 21-Sep-2025, MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved. At the time of the report, TOOTHACHE (teeth hurting), PAIN IN EXTREMITY (arm soreness) and HEADACHE (headache) was resolving. For mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use), the reporter did not provide any causality assessments. Concomitant medication was not reported. The patient did not experience any additional symptoms/events.; Reporter's Comments: The events of PAIN IN EXTREMITY, HEADACHE and TOOTHACHE were assessed as related due to temporal association and known safety profile of Spikevax. The benefit-risk relationship of product is not affected by this report.