Received Jul 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | 2 | — | — |
8 hours later, patient was on the floor in his bedroom/and he fell; hit his head; foaming at the mouth; This spontaneous case was reported by a consumer and describes the occurrence of FALL (8 hours later, patient was on the floor in his bedroom/and he fell), HEAD INJURY (hit his head) and FOAMING AT MOUTH (foaming at the mouth) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (8 hours later, patient was on the floor in his bedroom/and he fell), HEAD INJURY (hit his head) and FOAMING AT MOUTH (foaming at the mouth). At the time of the report, FALL (8 hours later, patient was on the floor in his bedroom/and he fell), HEAD INJURY (hit his head) and FOAMING AT MOUTH (foaming at the mouth) outcome was unknown. No concomitant medication was reported. The patient had taken their second Moderna shots. 8 hours later, he was on the floor in his bedroom, foaming at the mouth, and he fell and hit his head. Then rushed to the hospital. Battery test was performed, and they saw nothing. He never went back for another shot. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2025-787428 (E2B Linked Report). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2025: Upon internal review on 24-Jul-2025, significant correction was performed to remove the classification of Invalid, updated suspect product coding from Unspecified Moderna vaccine to Spikevax NOS.; Sender's Comments: US-MODERNATX, INC.-MOD-2025-787428:Master case