Age: 84.0
Sex: F
Vaccine: FLUX
Symptoms: Electrocardiogram normal, Endotracheal intubation, General physical health deterioration, Heart rate normal, Hypoxia
Clinical narrative: This case was reported in a literature article and described the occurrence of death in a 84-year-old female patient who received Influenza vaccine. Concurrent medical conditions included hypertension, hyperlipidemia, myelofibrosis and acute myeloid leukemia. Concomitant products included 5-Azacytidine. On an unknown date, the patient received influenza vaccine (unknown). On an unknown date, 91 days after receiving influenza vaccine, the patient experienced death (serious criteria death and GSK medically significant), takotsubo cardiomyopathy, vaccination failure (serious criteria GSK medically significant), influenza (serious criteria hospitalization), respiratory distress (serious criteria hospitalization and GSK medically significant), labored respiration (serious criteria hospitalization), tachycardia, crackles lung, hypoxia (serious criteria GSK medically significant), respiratory alkalosis, ventricular arrhythmia (serious criteria GSK medically significant) and lung congestion (serious criteria GSK medically significant). The patient was treated with oseltamivir, operations and procedures (intubation), non-drug therapy (ventilation) and non-drug therapy (cardiopulmonary resuscitation). On an unknown date, the outcome of the death was fatal and the outcome of the takotsubo cardiomyopathy, vaccination failure, influenza, respiratory distress, labored respiration, tachycardia, crackles lung, hypoxia, respiratory alkalosis, ventricular arrhythmia and lung congestion were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death, takotsubo cardiomyopathy, vaccination failure, influenza, respiratory distress, labored respiration, tachycardia, crackles lung, hypoxia, respiratory alkalosis, ventricular arrhythmia and lung congestion to be related to influenza vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a vaccination failure in an 84-year-old female patient who had received unspecified seasonal influenza vaccine (manufacturer unknown). Concurrent conditions included hypertension, hyperlipidemia, myelofibrosis and associated acute myeloid leukemia. Concomitant medication included chemotherapy of which she had received the last cycle with 5-Azacytidine 3 weeks before the event. No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided. On unspecified dates, the patient received a dose of unspecified seasonal influenza vaccine (dosage unknown; administration route unspecified; batch number not provided). On an unspecified date, approximately 3 months after the vaccination, the patient developed flu-like symptoms. She was seen at the oncology clinic 3 days later where a nasopharyngeal swab was taken that was positive for influenza A antigen of the H3N2 strain. Despite antiviral treatment, she required admission to hospital 2 days later due to respiratory distress and deterioration of the symptoms. Upon initial examination, she was noted to have important respiratory distress with laboured respiration; her temperature was 103.4 deg. F, her respiratory rate was 31 rpm and her oxygen saturation was 88% on air and 92% on an non-rebreather mask. According to the authors, her blood pressure and heart rate were within normal limits and her pulmonary auscultation was unremarkable. The patient seemed to improve with the continuation of the treatment on the following days; but 3 days after admission she required intubation and mechanical ventilation as she had become acutely short of breath, tachycardic with bibasilar crackles on auscultation, hypoxic and was noted to have respiratory alkalosis. After further examination she was first believed to have acute coronary syndrome but she was finally diagnosed with Takotsubo cardiomyopathy. However she developed a ventricular arrhythmia and she died on day 4 of hospitalisation despite aggressive medical treatment and cardiopulmonary resuscitation. This case was considered serious as it had a fatal outcome. Cause of death was unspecified, it was unknown if a post-mortem was performed. Her initial chest x-ray and electrocardiogram were unrevealing, but when repeated after 3 days the X-ray showed pulmonary vascular congestion and left basilar airspace disease; and the electrocardiogram showed new T-wave inversions in V3 to V6. Her cardiac troponin level was 1.949 ng/mL, creatinine was 1.3 mg/dL and brain natriuretic peptide was 2224 pg/mL. She underwent a bedside echocardiogram performed by a cardiologist that revealed a reduced left ventricular ejection fraction (30%) and severe hypokinesis of all mid to distal walls and apex. According to the authors, these results were suggestive of apical ballooning syndrome or Takotsubo cardiomyopathy. Initial treatment consisted of oral oseltamivir that was started at her oncology outpatient clinic. She later required intubation and mechanical ventilation, dieresis, unspecified medical management and unspecified cardiopulmonary resuscitation. The authors did not comment on any causal relationship between the events and the vaccination. The authors concluded that "Influenza A infection has rarely been linked to the development of Takotsubo cardiomyopathy. Excessive catecholamine release is believed to play a role in the pathogenesis and the treatment is largely empirical and supportive. Although Takotsubo cardiomyopathy -related mortality rates are low (1-3.2%), patients with associated severe infections such as influenza have a worse prognosis. Identifying influenza patients with higher mortality risks may allow for more favourable clinical outcomes in these patients".