Sex: F
Vaccine: FLUA3
Symptoms: Cough, Dyspnoea, Fatigue, Insomnia, Pain
Clinical narrative: Not able to sleep; Trouble breathing; Throat closed up; Tired all day; Coughing; Feeling achy; This is a spontaneous case, initially received from other non-health professional via Communications (reference number: SEQ19-02681) on 13-Sep-2019, concerning a 65-year-old, female patient.   The patient's medical history included Augmentin (amoxicillin, clavulanic acid) for unknown indication.   On 12-Sep-2019, the patient was administered Fluad [Influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose, route of administration, anatomical location, batch number and expiration date: not reported] as protection against seasonal influenza.  On the same day, 12 hours after vaccination, the patient's throat closed up and she had trouble breathing. The patient was not able to sleep, had been tired all day, along with coughing and feeling achy. As reported, the patient had a reaction similar to this after taking Augmentin years ago, but at that time, she also had a rash, which she did not have now.   The patient did not seek medical treatment, but it was unknown if she received any treatment.  At the time of initial reporting, the outcome of the events was not resolved (reported as ongoing).  The reporter assessed the case as serious and did not provide causality assessment.  The reporter did not give consent to be contacted for further information.  Company comment: A 65-year-old, female patient experienced insomnia, dyspnoea, throat tightness, fatigue, cough and pain after vaccination with the suspect product Fluad (TIV). Chronology is plausible. Reportedly, the patient had a reaction similar to this after taking Augmentin years ago. Patient medical history of reported Augmentin reaction with similar events suggest presence of allergic predisposition which was not reported. Presence of adjuvants in vaccine (egg-derivates) may have triggered some sort of allergic reaction in the patient. Medical data of the patient is necessary for the assessment of causality. For now, considering provided information, causality is assessed as related to the product for the events of dyspnoea, throat tightness, fatigue, cough and pain, however not related to insomnia due to physiological inconsistency.; Reporter's Comments: A 65-year-old, female patient experienced insomnia, dyspnoea, throat tightness, fatigue, cough and pain after vaccination with the suspect product Fluad (TIV). Chronology is plausible. Reportedly, the patient had a reaction similar to this after taking Augmentin years ago. Patient medical history of reported Augmentin reaction with similar events suggest presence of allergic predisposition which was not reported. Presence of adjuvants in vaccine (egg-derivates) may have triggered some sort of allergic reaction in the patient. Medical data of the patient is necessary for the assessment of causality. For now, considering provided information, causality is assessed as related to the product for the events of dyspnoea, throat tightness, fatigue, cough and pain, however not related to insomnia due to physiological inconsistency.