Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
syphilis; This spontaneous case was reported by a consumer and describes the occurrence of SYPHILIS (syphilis) in a 66-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The patient's past medical history included Hysterectomy. Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Batch Number: 053D22A, dose and expiry date was unknown.) on 17-Nov-2022, Moderna COVID-19 Vaccine (Batch Number: 038K20A), SPIKEVAX NOS (2 shots, unknown details) and Moderna COVID-19 Vaccine (Batch Number: 016M20A). Past adverse reactions to the above products included No adverse effect with MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and SPIKEVAX NOS. On 14-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On 28-Nov-2024, after starting, the patient experienced SYPHILIS (syphilis) (seriousness criterion medically significant). At the time of the report, SYPHILIS (syphilis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2024, Syphilis test: Positive. Concomitant medications were not reported. The patient had total 7 Moderna COVID-19 vaccine since they came out. The patient was sexually inactive. The patient went to neurologist 2 weeks after the administration, drew her blood and told her that she had syphilis. The patient had not had sex since 2009. The patient said she knew she didn't have syphilis, unless her ex-husband had given it to her at some point. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported.; Reporter's Comments: Due to lack of biological plausibility, the causality of the event was assessed as not related to the vaccine. The benefit-risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Hysterectomy
Test Date: 20241128; Test Name: Syphilis test; Test Result: Positive