Age: 81.0
Sex: F
Vaccine: FLUA3
Symptoms: Immediate post-injection reaction
Clinical narrative: Heart attack symptoms; Rapid heart beat; Blood pressure increased; Dizziness; Weakness; May have been allergic to; This spontaneous case was received on 08-Mar-2021 from other non-health professional (consumer's spouse) via Agency (reference number: SEQW21-00923) and concerned an 81-year-old, female patient.   The patient's concurrent conditions included irritable bowel syndrome and indigestion. The patient's concomitant medications included lisinopril, metoprolol, baby aspirin (acetylsalicylic acid), all used for an unreported indication and unspecified supplements for indigestion.  On 13-Dec-2019, the patient was vaccinated with Fluad (TIV) (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration and anatomical location: not reported) for prevention of seasonal influenza. The batch number reported was 260397, expiry date: 30-Jun-2020.  On the same day, after receiving Fluad (TIV), the patient had an immediate reaction that included heart attack symptoms, rapid heart beat, blood pressure increased, dizziness and weakness. The patient was hospitalised. The reporter stated that the patient may had been allergic to.  On an unspecified date in Dec-2020, the patient was treated with intravenously (IV) unspecified heart medications and it reversed itself. The patient recovered from the events.    On 19-Dec-2020, the patient was discarded from the hospital.  On an unspecified date in Jun-2020, six months later as reported, the patient visited cardiologist who advised that there was no heart damage.  The events were assessed to be related to Fluad (TIV). The reporter would like to know the ingredients of this particular vaccine to see what his wife may have been allergic to. The patient also stated she seen a cardiologist 6 months later who advised there was no heart damage and she stated she thought the adverse event was induced by the vaccine injection.  This case was assessed as serious.  Company comment: An 81-year-old subject was administered Fluad (TIV). On the same day, after receiving Fluad (TIV), the patient had an immediate reaction that included heart attack symptoms, rapid heart beat, blood pressure increased, dizziness and weakness. The patient was hospitalised. The reporter stated that the patient may had been allergic to. The patient's concurrent conditions included irritable bowel syndrome and indigestion. The patient's concomitant medications included lisinopril, metoprolol and acetylsalicylic acid, all used for an unreported indication. However, reported concomitant medications suggest underlying cardiovascular condition that may have contributed to development of the events. Chronology is plausible. Causal role of the suspect vaccine is assessed as possibly related for hypersensitivity, dizziness, heart rate increased, blood pressure increased and asthenia. For the event of myocardial infarction, causality is unassessable, due to lack of information regarding diagnostic findings, it was not confirmed whether the patient had heart attack.; Reporter's Comments: The reporter would like to know the ingredients of this particular vaccine to see what his wife may have been allergic to. The patient also stated she seen a cardiologist 6 months later who advised there was no heart damage and she stated she thought the adverse event was induced by the vaccine injection.; Sender's Comments: An 81-year-old subject was administered Fluad (TIV). On the same day, after receiving Fluad (TIV), the patient had an immediate reaction that included heart attack symptoms, rapid heart beat, blood pressure increased, dizziness and weakness. The patient was hospitalised. The reporter stated that the patient may had been allergic to. The patient's concurrent conditions included irritable bowel syndrome and indigestion. The patient's concomitant medications included lisinopril, metoprolol and acetylsalicylic acid, all used for an unreported indication. However, reported concomitant medications suggest underlying cardiovascular condition that may have contributed to development of the events. Chronology is plausible. Causal role of the suspect vaccine is assessed as possibly related for hypersensitivity, dizziness, heart rate increased, blood pressure increased and asthenia. For the event of myocardial infarction, causality is unassessable, due to lack of information regarding diagnostic findings, it was not confirmed whether the patient had heart attack.