Received Jan 6, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | — | IM |
Feel just a little disoriented/ Just kind of disoriented; Slightly dizzy; feel some slight maybe fever or tiredness/ hardly any fever/ Maybe slight fever; feel some slight maybe fever or tiredness/ more a little fatigue/ a little fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Feel just a little disoriented/ Just kind of disoriented), DIZZINESS (Slightly dizzy), PYREXIA (feel some slight maybe fever or tiredness/ hardly any fever/ Maybe slight fever) and FATIGUE (feel some slight maybe fever or tiredness/ more a little fatigue/ a little fatigue) in a 78-year-old male patient who received mRNA-1283 (MNEXSPIKE PFS) for COVID-19 prophylaxis. The suspect product included Pre-filled Syringe injection for COVID-19 prophylaxis. The patient's past medical history included Anaphylactic reaction to drug (possible anaphylactic reaction to trazodone 20 years ago) since an unknown date and Surgical procedure (Patient had 3 major surgeries). Previously administered products included for Product used for unknown indication: TRAZODONE (The reaction happened 20 years ago only once with the drug and almost life-threatening where patient felt his throat was closed and breathing was impaired.) and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included Anaphylactic reaction with TRAZODONE; and No adverse effect with PFIZER BIONTECH COVID-19 VACCINE. On 30-Dec-2025, the patient received dose of mRNA-1283 (MNEXSPIKE PFS) (Intramuscular use) 1 dosage form. On an unknown date, the patient started Pre-filled Syringe (unknown route) at an unspecified dose. On 30-Dec-2025, the patient experienced DISORIENTATION (Feel just a little disoriented/ Just kind of disoriented), DIZZINESS (Slightly dizzy), PYREXIA (feel some slight maybe fever or tiredness/ hardly any fever/ Maybe slight fever) and FATIGUE (feel some slight maybe fever or tiredness/ more a little fatigue/ a little fatigue). At the time of the report, DISORIENTATION (Feel just a little disoriented/ Just kind of disoriented), DIZZINESS (Slightly dizzy), PYREXIA (feel some slight maybe fever or tiredness/ hardly any fever/ Maybe slight fever) and FATIGUE (feel some slight maybe fever or tiredness/ more a little fatigue/ a little fatigue) had not resolved. No concomitant medications were reported. It was reported that the patient took vaccination on 30 December 2025 (3:30 PM - 4:00 PM). It was reported that patient had previously received Pfizer vaccine. Patient had symptoms including slight fatigue, possible mild fever, and disorientation lasting approximately 12 to 20 hours post-vaccination. It was reported feeling slightly dizzy but denied headache and significant fever, stating they would need to check the temperature to confirm. It was reported that patient had concern about anaphylaxis, mentioning he had never experienced it before. Patient had no other history of anaphylaxis, despite taken multiple medications. It was unknown if the patient experienced any additional symptoms or events. No treatment medications were reported. Reporter did not allow further contact
Anaphylactic reaction to drug (possible anaphylactic reaction to trazodone 20 years ago)
Medical History/Concurrent Conditions: Surgical procedure (Patient had 3 major surgeries)