Received Nov 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | IM |
Neck fracture; Pain throughout her body; Fall down ten steps; This spontaneous case was reported by a consumer and describes the occurrence of CERVICAL VERTEBRAL FRACTURE (Neck fracture) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. Previously administered products included for COVID-19 prophylaxis: Spikevax NOS (It was reported that the patient consistently receiving Moderna's COVID-19 vaccine.). Past adverse reactions to the above products included No adverse effect with Spikevax NOS. Concurrent medical conditions included COPD (long-standing COPD) and Cancer (NOS). Concomitant products included Pembrolizumab (Keytruda) for Cancer (NOS), Influenza vaccine (Flu) for an unknown indication. On 17-Nov-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On an unknown date, the patient experienced CERVICAL VERTEBRAL FRACTURE (Neck fracture) (seriousness criterion medically significant), PAIN (Pain throughout her body) and FALL (Fall down ten steps). At the time of the report, CERVICAL VERTEBRAL FRACTURE (Neck fracture) outcome was unknown and PAIN (Pain throughout her body) and FALL (Fall down ten steps) had resolved. It was reported that the patient asked about side effects she experienced from last year's Moderna COVID-19 vaccine, inquired if the formula had been updated for this year, and requested details on the new MNEXPIKE vaccine for individuals aged 65 and older. It was reported that the patient consistently receiving Moderna's COVID-19 vaccine and noted that she took her COVID-19 shot on 17-Nov-2024. It was reported that a flu vaccine was administered a couple of weeks before this. It was reported that the patient had severe reactions, experiencing pain throughout her body, which led to a fall down ten steps, resulting in a neck fracture and a two-week rehabilitation period. Additionally, it was shared that she had a long-standing COPD condition before COVID-19 and was undergoing cancer treatment with Keytruda, receiving infusions every three weeks for at least two years and five months. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided.; Reporter's Comments: Concurrent medical condition Cancer is a contributor for cervical vertebral fracture. The benefit -risk relationship of product is not affected by this report.
Cancer (NOS); COPD (long-standing COPD)
Flu; Keytruda