Received Dec 18, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA MNEXSPIKE)) | MODERNA | UNK | No batch number | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | IM |
Got pain; Immediately had the palpitations that night/ the palpitations got worse/racing heart/ really racing heart at night and palpitations during the day/ heart palpitations on any exc; Did had a reaction; Something happened with metabolic; Heart pain/Angina pectoris; Felt like heart is inflammed; This spontaneous case initially received on 03-Dec-2025, was reported by a non health professional and concerns a patient of unknown age/gender. Administration of company suspect drug: On 12-Nov-2025, the patient received Fluad (TIV) for Active immunization for the prevention of influenza disease, Dose regimen: 0.5 ml, Route of administration: Intramuscular, Anatomical location: Not reported, Lot number: No batch number available, and would be requested upon follow-up. Non-company suspect drugs: Mnexspike 2024-2025 formula (COVID-19 vaccine mRNA omicron (mRNA 1283)), Dose regimen: 0.2 ml, Route of administration: Not reported, Anatomical location: Not reported, Lot number: No batch number available, and would be requested upon follow-up. Adverse reactions/events and outcomes: On 12-Nov-2025, the patient experienced Immediately had the palpitations that night/ the palpitations got worse/racing heart/ really racing heart at night and palpitations during the day/ heart palpitations on any exc (outcome: Not recovered / Not resolved). On 13-Nov-2025, the patient experienced Got pain (outcome: Unknown). On Nov-2025, the patient experienced Heart pain (Medically Significant, outcome: Unknown), Felt like heart is inflammed (Medically Significant, outcome: Unknown), Did had a reaction (outcome: Unknown), Something happened with metabolic (outcome: Unknown). On 12-Nov-2025, the patient experienced Palpitations (immediately had the palpitations that night/ the palpitations got worse/racing heart/ really racing heart at night and palpitations during the day/ heart palpitations on any exc). On 13-Nov-2025, the patient experienced Pain (got pain). In Nov-2025, the patient experienced angina pectoris (heart pain) (seriousness criterion medically significant), carditis (feel like heart is inflammed) (seriousness criterion medically significant), immunization reaction (the patient did had a reaction) and metabolic disorder (something happened with metabolic). Fluad (TIV) action taken: Not Applicable Reporter's assessment: The primary reporter (other) considered the events Heart pain and Felt like heart is inflammed as serious (Medically significant) and did not provide the seriousness for the rest of events. And did not provide the causality assessment for all the events.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, all the events are considered related for reporting purposes. Considering close temporal association (same day of vaccine administration) for palpitations, and pain, Implied temporal association for immunization reaction(reaction to immunisation). For events angina pectoris, carditis and metabolic disorder considering insufficient information regarding drug event temporality, investigations, treatment received, relevant medical history, and concomitant medications to perform a more in-depth analysis. Concomitant administration of non-company suspect Mnexspike 2024-2025 formula is considered a confounder.
Comments: None