Received Aug 26, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUAD) | SEQIRUS, INC. | UNK | 390224 | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUAD) | SEQIRUS, INC. | UNK | 390224 | — |
Passed in an ICU; Severe pneumonia; Congestive heart failure; Damaged kidneys (later diagnosed with Stage 3 kidney failure); Atrial fibrillation (AFib); Intolerance/allergy to egg protein and autoimmune issues; Grabbed her chest for the first time, in panic/complaining of chest pain feeling like a heart attack; Palpitations; This spontaneous case, initially received on 15-Aug-2025, was reported by a non-health professional and concerns an elderly female patient. Past medical history included Fall, rehab for 2 months. At the time of the event the patient had rheumatoid arthritis, Irritable bowel syndrome (IBS), previous cancers, MTHFR Vitamin deficiencies, depression, bruised rib from a fall, egg allergy. Concomitant medication: refer to appropriate report section. Administration of company suspect drug: On 04-Nov-2024 17:00, the patient received Fluad (TIV) for Influenza prophylaxis, Dose regimen: Not reported, Route of administration: Not reported, Anatomical site: Not reported, Lot number: 390224. No additional suspect drugs. Adverse reactions/events and outcomes: On Nov-2024, the patient experienced Atrial fibrillation(AFib) associated symptoms of Palpitations and chest pain. On 01-Dec-2024, the patient experienced Severe pneumonia (Hospitalized, outcome: Recovered / Resolved). On Dec-2024, the patient experienced Congestive heart failure (Hospitalized, outcome: Not Reported), Damaged kidneys (later diagnosed with Stage 3 kidney failure) (Hospitalized, outcome: Not Reported). On an unknown date, the patient experienced Intolerance/allergy to egg protein and autoimmune issues (outcome: Not reported). On 25-May-2025, the patient passed in an ICU (Hospitalized, outcome: Fatal). The patient died on 25-May-2025. The cause of death and autopsy details were not provided. On 04-Nov-2024, the patient got the Fluad 65 vaccine at 17:00, and within an hour she grabbed her chest for the first time, in panic. Within 30 hours after the vaccine, she went into the Emergency room (ER) for about 6-8 hours complaining of chest pain feeling like a heart attack. They found nothing wrong except for a bruised rib from a fall she had on 31-Oct-2024. The bruised rib was helped with ice packs and a heating pad, but all they said about the heart was that she had palpitations and a newly diagnosed Atrial fibrillation (AFib). Later that same day, 06-Nov-2024, we went to another ER that has a great cardiology wing of the hospital but they still couldn't find anything wrong, just mentioning that she had AFib, which had never been an issue in the past, was now active and showing signs of being unstable. There was nothing they felt needed to be done at the time. She went home with an unstable heart and laid in bed with rib pain and heart issues, going back to the ER several more times in Nov-2024. On 12-Nov-2024, the patient went back into the ER for a whole day with her Afib very unstable and uncontrolled by medication. The ER preformed a cardio version on her. It helped her AFib stabilize temporarily but then she was still in and out of the ER several more times. She then began going to a cardiologist and had several tests run on her heart. On 01-Dec-2024, she went into the hospital with severe pneumonia and AFib that was out of control. She spent 10 days in the hospital as they cleared the pneumonia, gave her 2 stints, and controlled the AFib fully with meds, but she was left with congestive heart failure and damaged kidneys (later diagnosed with Stage 3 kidney failure). She continued living with us for the next 5 months, and a rehab for 2 months, in and out of hospitals and ER's, getting weaker and weaker until she eventually passed in an Intensive Care Unit (ICU) on 25-May-2025. Once they realized the connection to the timing of the vaccine and all of her health issues, they began to look into exactly which vaccine she got and what were possible reasons for her body to react in the way it did. We found a precaution warning not take Fluad65 if a person has an intolerance/allergy to egg protein, which she did. Fluad (TIV) action taken: Not Applicable Reporter's assessment: The reporter assessed event passed in an ICU as serious (Hospitalized, Death) and did not provide the causality assessment. The reporter assessed events AFib, Severe pneumonia, Congestive heart failure, Damaged kidneys (later diagnosed with Stage 3 kidney failure) as serious (Hospitalized) and did not provide the causality assessment. The reporter did not provide the seriousness and causality assessment for the events Grabbed her chest for the first time, in panic/complaining of chest pain feeling like a heart attack, Palpitations, Rib pain, Getting weaker and weaker and Intolerance/allergy to egg protein and autoimmune issues.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, all events are considered related for reporting purposes. Related for event atrial fibrillation considering implied temporal relationship (symptom of chest pain started within one hour after vaccine administration). Furthermore, the contraindicated product administration (intolerance/allergy to egg protein) could have contributed to the event atrial fibrillation. The events pneumonia, congestive cardiac failure, chronic kidney disease are considered coincidental with no biological plausibility for the product to cause/contribute. The medical history of previous cancers (unspecified) is considered as risk factors for events reported. Related for the event death, due to the lack of the information (cause of death, autopsy details). However, the events of atrial fibrillation, pneumonia, congestive cardiac failure, chronic kidney disease could have contributed to the event death.; Reported Cause(s) of Death: Passed in an ICU
Cancer; Depression; Egg allergy; Irritable bowel syndrome; Rheumatoid arthritis; Rib contusion; Vitamin deficiency
Medical History/Concurrent Conditions: Fall; Rehabilitation therapy
Methotrexate; Amlodipine; Desvenlafaxin extended release; Levothyroxine; Losartan; Meloxicam; Omeprazole; Propranolol; Simvastatin; L-methylfolate; Probiotics; Folic acid; Vit b12; Vit c; Vit d