Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 80777-0400-60 | IM |
Total loss of bladder control (2.5 days); Severe nerve pain upper and lower body along with intense chills; Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling; Severe nerve pain upper and lower body along with intense chills; received 0.2 microgram dose; Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling; Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (Total loss of bladder control (2.5 days)), NEURALGIA (Severe nerve pain upper and lower body along with intense chills), MOVEMENT DISORDER (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling), GAIT DISTURBANCE (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling) and FALL (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling) in a 66-year-old female patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 80777-0400-60) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 microgram. In September 2025, the patient experienced MOVEMENT DISORDER (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling) and GAIT DISTURBANCE (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling). On 16-Sep-2025, after starting mRNA-1283 (MNEXSPIKE PFS), the patient experienced URINARY INCONTINENCE (Total loss of bladder control (2.5 days)), NEURALGIA (Severe nerve pain upper and lower body along with intense chills), FALL (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling), CHILLS (Severe nerve pain upper and lower body along with intense chills) and UNDERDOSE (received 0.2 microgram dose). At the time of the report, URINARY INCONTINENCE (Total loss of bladder control (2.5 days)), NEURALGIA (Severe nerve pain upper and lower body along with intense chills), MOVEMENT DISORDER (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling), GAIT DISTURBANCE (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling), FALL (Inability to move arms, legs, trunk (could not stand, walk or get out of bed or up from floor after falling), CHILLS (Severe nerve pain upper and lower body along with intense chills) and UNDERDOSE (received 0.2 microgram dose) was resolving. Concomitant medication was not reported. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.