Received Oct 20, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | 3052669 | IM |
inability to speak coherently; incontinence; involuntary groaning; chills; headache; vomiting; 6-8 hours of fever; This spontaneous case was reported by a consumer and describes the occurrence of APHASIA (inability to speak coherently), INCONTINENCE (incontinence), MOANING (involuntary groaning), CHILLS (chills) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273.251 (Spikevax LP.8.1 PFS) (batch no. 3052669) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Oct-2025, the patient received dose of mRNA-1273.251 (Spikevax LP.8.1 PFS) (Intramuscular use) .5 milliliter. In October 2025, the patient experienced APHASIA (inability to speak coherently), INCONTINENCE (incontinence), MOANING (involuntary groaning), CHILLS (chills), HEADACHE (headache), VOMITING (vomiting) and PYREXIA (6-8 hours of fever). The patient was treated with Paracetamol (Tylenol) in October 2025 for Headache, at an unspecified dose and frequency. In October 2025, PYREXIA (6-8 hours of fever) had resolved. At the time of the report, APHASIA (inability to speak coherently), INCONTINENCE (incontinence), MOANING (involuntary groaning), CHILLS (chills), HEADACHE (headache) and VOMITING (vomiting) had resolved. No Concomitant medications were reported. Patient experienced symptoms about 12 hours later, including 6-8 hours of fever, chills, vomiting, incontinence, headache, incoherent speech, and involuntary groaning. The episode was described as the worst in their life. There was a concern about possible neurological side effects. Tylenol was taken on the second day, followed by vomiting. The patient had no medical history or risk factors, and no lab results were available.; Reporter's Comments: Due to lack of biological plausibility, Incontinence and moaning events were assessed as not related to the vaccine. The benefit -risk relationship of product is not affected by this report.