Received Sep 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 6328773 | IM |
he cannot drive and he is afraid he is going to fall.; very off balance; he is feeling dizzy/I am so dizzy, it's terrible/Light headedness; I'm very very uncomfortable and really nervous; insomnia/his lack of sleep/as I say/I am not sleeping anyway; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (insomnia/his lack of sleep/as I say/I am not sleeping anyway), PHOBIA OF DRIVING (he cannot drive and he is afraid he is going to fall.), NERVOUSNESS (I'm very very uncomfortable and really nervous), DIZZINESS (he is feeling dizzy/I am so dizzy, it's terrible/Light headedness) and BALANCE DISORDER (very off balance) in an 81-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) (batch no. 6328773) for COVID-19 prophylaxis. Concurrent medical conditions included Insomnia in April 2025. Concomitant products included Eszopiclone (Lunesta) from 2025 to an unknown date for Insomnia. On 11-Sep-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) .2 milliliter. On 13-Sep-2025, the patient experienced PHOBIA OF DRIVING (he cannot drive and he is afraid he is going to fall.), DIZZINESS (he is feeling dizzy/I am so dizzy, it's terrible/Light headedness) and BALANCE DISORDER (very off balance). In September 2025, the patient experienced INSOMNIA (insomnia/his lack of sleep/as I say/I am not sleeping anyway) and NERVOUSNESS (I'm very very uncomfortable and really nervous). At the time of the report, INSOMNIA (insomnia/his lack of sleep/as I say/I am not sleeping anyway), PHOBIA OF DRIVING (he cannot drive and he is afraid he is going to fall.), NERVOUSNESS (I'm very very uncomfortable and really nervous), DIZZINESS (he is feeling dizzy/I am so dizzy, it's terrible/Light headedness) and BALANCE DISORDER (very off balance) had not resolved. No vaccines were given 4 weeks prior to the mNEXSPIKE. The patient had a nuclear stress test (cardiac stress test). He was injected with nuclear medicine on 8-Sep-2025 (Monday). The patient received the vaccine on 11-Sep-2025 and had no reaction on 12-Sep-2025, but from 13-Sep-2025 up till the day of reporting, he had a powerful reaction. He was feeling dizzy, light-headed and very off balance. The patient could not drive, and he was afraid he was going to fall. He did not experience it in the middle of the night because he got up plenty of times as he was not sleeping anyway. He was fine in the morning until he ate something. He walked 4 streets, for a little exercise, and when he came in and had breakfast, he couldn't navigate his way across the living room. The patient was having insomnia for several months, since April 2025 and was taking Lunesta (sleeping pill). The patient was homebound and was very uncomfortable and really nervous about this. It was not reducing. He was not feeling any better. Because of his lack of sleep, he didn't know what the situation was on Friday, but Saturday was terrible, and Sunday was also very bad. Patient did not know if it was decreasing, it might be somewhat. The patient was so dizzy, it was terrible. It is unknown if the patient experienced any additional symptoms/events. No treatment medication was reported. Reporter causality was not provided.
Medical History/Concurrent Conditions: Insomnia
Lunesta