Received Feb 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 407286 | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | 3053317 | IM |
Projectile vomiting; Diarrhoea/ looser stool; Slight headache; Rapid weight loss up to 9 pounds over a three-day period; This spontaneous case initially received on 14-Jan-2026 (including additional information received on 15-Jan-2026), was reported by a non-health professional and concerns a male patient. Past medical history included gained all the weight. At the time of the event the patient had shellfish allergy {The reporter compared the experience to the shellfish poisoning that the patient had before). Concomitant medication was not provided. Administration of company suspect drug: On 03-Nov-2025, the patient received Fluad (TIV) for an unknown indicaion, Dose regimen: 1 DF, Route of administration: Not reported, Anatomical location: Not reported, Lot number: 407286. Non-company suspect drugs: On 03-Nov-2025, the patient received Spikevax 2024-2025 formula (COVID-19 vaccine mRNA omicron (KP.2) Moderna) for COVID-19 prophylaxis, Dose regimen: 1 DF, Route of administration: Intramuscular, Anatomical location: Not reported, Lot Number: 3053317. Adverse reactions/events and outcomes: On 06-Nov-2025, 3 days after vaccination, the patient experienced Slight headache (outcome: Unknown). On 07-Nov-2025 at 11:00, 4 days after vaccination, the patient experienced Diarrhoea/ looser stool (outcome: Recovered / Resolved, stop date: 11-Nov-2025). On 07-Nov-2025 at 16:00, 4 days after vaccination, the patient experienced Projectile vomiting (outcome: Recovered / Resolved, stop date: 07-Nov-2025). On an unknown date in Nov-2025, the patient experienced Rapid weight loss up to 9 pounds over a three-day period (outcome: Recovered / Resolved, stop date: 09-Dec-2025). The patient had no other allergies to medications, and other products. The patient had not received any vaccines in the weeks prior to adverse event. It was reported that the patient had received the Spikevax vaccine on 03-Nov-2025, and by 07-Nov-2025, patient had started experiencing projectile vomiting and diarrhea. It was mentioned that the patient had rapid weight loss up to 9 pounds over a three-day period. It was further reported that the patient had also received the flu vaccine, Fluad-Tri, on the same day as the Spikevax vaccine. It was reported that the symptoms had resolved and the patient had regained all the weight by 09-Dec-2025. Three days after receiving the injections, the patient awoke with a slight headache and seemed to use the washroom frequently. There was a looser stool on the fourth day in the morning and projectile vomiting in the late afternoon, followed by full-on diarrhoea. The vomiting occurred just once, and the diarrhoea over a 2-bay period. The diarrhoea and projectile vomiting events did not cause the patient to seek medical care, and there were no other factors that could have led to the adverse event. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The reporter provided seriousness assessment as unknown and did not provide causality assessment for all events.; Reporter's Comments: Due to the spontaneous nature of the case, the events are considered related for reporting purposes.
Shellfish allergy
Medical History/Concurrent Conditions: Weight gain