Received Jul 22, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | EL1284 | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUZONE) | SANOFI PASTEUR | UNK | 49281-424-50/UT | — |
flu like symptoms; SOB; Arrhythmia cardiac (NOS); Atrial Fibrillation; Tachycardia; arial tachycardia; atrial Hypertropy; Initial information received on 13-Jul-2026 regarding an unsolicited valid serious courtesy case received from a non-healthcare professional (consumer). This case involves a patient of unknown age and unknown gender who experienced Arrhythmia cardiac (NOS), Atrial Fibrillation, Tachycardia, arial tachycardia, atrial Hypertropy, and flu like symptoms after receiving Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] (Fluzone Trivalent 2024-2025), Comirnaty (Comirnaty (2024-2025 Formula)/Bnt162b2 Omicron (Kp.2)), and Humalog. The patient's past medical history, past drug history, vaccination history, and family history were not provided. Concomitant medications were not reported. At the time of the event, the patient had ongoing condition(s) of insulin-dependent diabetes mellitus (IDDM) [Type 1 diabetes mellitus]. On 17-Sep-2024, the patient received a dose 1 of Influenza Usp Trival A-B Subvirion No Preservative Vaccine [Fluzone] suspension for injection (batch/lot number: 49281-424-50/UT8415NA, expiry date: 30-Jun-2025) (strength: unknown)via unknown route in an right shoulder for prophylactic vaccination [Immunisation]. On 02-Jan-2021, the patient received a unknown dose via intramuscular route of Comirnaty Not produced by Sanofi Pasteur (dose 1, batch/lot number: EL1284, expiry date: 30-Apr-2021) (strength: unknown) in an left arm for prophylactic vaccination [Immunisation]. On 23-Jan-2021, the patient received dose 2 via intramuscular route (batch/lot number: EW3302, expiry date: 31-May-2021). On 27-Sep-2021, the patient received dose 3 via intramuscular route (batch/lot number: EW0196, expiry date: 03-Dec-2021). On 02-May-2022, the patient received dose 4 via intramuscular route (batch/lot number: FM9992, expiry date: 07-Jul-2022). On 17-Sep-2024, the patient received dose 5 via intramuscular route (batch/lot number: LM2223, expiry date: 11-Mar-2025). On 06-Jan-1989, the patient received a 0.9 international unit(s) every hour (QH) dose of Humalog Not produced by Sanofi Pasteur (batch/lot number: unknown, expiry date: unknown) (strength: unknown) via unknown route for insulin-dependent diabetes mellitus (IDDM) [Type 1 diabetes mellitus]. The dosage was reported as 0.9 units/hour plus carbohydrate bolus. On 05-Dec-2023, the patient developed Arrhythmia cardiac (NOS) (Arrhythmia), Atrial Fibrillation, SOB (Dyspnoea), Tachycardia , arial tachycardia and atrial Hypertropy (and latency: unknown). On an unknown date, the patient developed flu like symptoms (Influenza like illness and latency: unknown). Relevant laboratory test results included: Ejection fraction- On 05-Dec-2023 with result 31%. Radioisotope CT scan (Positron emission tomogram) - On an unspecified date with evaluation: negative. Result notes indicated that atrial hypertrophy was present, ejection fraction continued to be below normal, atrial tachycardia continued intermittently, and the patient continued Pradaxa. Action taken was not applicable. Corrective treatment: Not reported. Event outcome: Outcome was unknown for all the events. Seriousness criteria: Arrhythmia cardiac (NOS) (Arrhythmia), Atrial Fibrillation (Atrial fibrillation), SOB (Dyspnoea), Tachycardia, arial tachycardia (Atrial tachycardia), and atrial Hypertropy (Atrial hypertrophy) were serious due to life-threatening and disabling/incapacitating criteria.
Insulin-dependent diabetes mellitus
Comments: NONE
Humalog
Test Date: 20231205; Test Name: Ejection fraction; Test Result: 31 %; Test Name: Radioisotope CT Scan; Result Unstructured Data: Atrial hypertrophy is present, Ejection Fraction continues to be below normal, Atrial tachycardia continues intermittently, continued Pradaxa.