Age: 72.0
Sex: F
Vaccine: FLU4, FLU3
Symptoms: Acute respiratory failure, Fungal infection, Influenza, Vaccination failure
Clinical narrative: Initial information received on 19-Jun-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp via call center via other company (GSK) (under reference number: US2018091640). This case involves a 72 years old female patient who experienced acute lung failure, flu and yeast infection, while she received vaccine FLUZONE HIGH DOSE and while treated with ADVAIR DISKUS. The patient's past medical history included Drug hypersensitivity to Statins, Aspirin and Codeine. The patient's past vaccination(s) and family history were not provided. Concomitant medications included PLAVIX for Product used for unknown indication; IPRATROPIUM BROMIDE for Product used for unknown indication; and PROAIR for Product used for unknown indication. On an unknown date, the patient started taking ADVAIR DISKUS dosage unknown inhalational (lot - 7ZP4239, 31-Dec-2018) for Chronic obstructive pulmonary disease. On an unspecified date in Nov-2017, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI892AB. On 30-Dec-2017, the patient developed a serious acute lung failure (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of FLUTICASONE PROPIONATE and SALMETEROL XINAFOATE. The patient was hospitalized for this event during 6 days. On 25-Dec-2017, the patient developed a serious flu (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of FLUTICASONE PROPIONATE and SALMETEROL XINAFOATE. The patient was hospitalized for this event during 6 days. On an unknown date, the patient developed a serious yeast infection (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of FLUTICASONE PROPIONATE and SALMETEROL XINAFOATE. The patient was hospitalized for this event during 6 days. On 25-Dec-2017, the patient developed a serious suspected vaccination failure (unknown latency) following the first dose intake and (unknown latency) following the last dose intake of FLUTICASONE PROPIONATE and SALMETEROL XINAFOATE. The patient was hospitalized for this event during 6 days. On 30-Dec-2017, the patient developed a serious acute lung failure (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event during 6 days. On 25-Dec-2017, the patient developed a serious flu (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event during 6 days. On an unknown date, the patient developed a serious yeast infection (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event during 6 days. On 25-Dec-2017, the patient developed a serious suspected vaccination failure (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event during 6 days. No laboratory data was reported. Final diagnosis was flu, acute lung failure and yeast infection. ADVAIR DISKUS was continued. The patient was treated with CIPRO for Fungal infection. The patient outcome is reported as Recovered / Resolved on an unknown date for acute lung failure, as Recovered / Resolved on an unknown date for flu, as Not Applicable for suspected vaccination failure and as Unknown for yeast infection. It was reported that the reporter considered the vaccination failure, acute respiratory failure and influenza to be related to Influenza vaccine Quadrivalent. The reporter considered the yeast infection to be possibly related to both the suspects. Documents held by sender: None. Sender's Comments: This case concerns an elderly patient with history of drug allergy and on medication for respiratory obstructive disease who presented with acute lung failure, flu-like illness and yeast infection on an unknown date after vaccination with FLUZONE HD vaccine. The time to onset is unknown and patient is predisposed towards respiratory insufficiency owing to her advanced age and past medical history. There is no information regarding patient's immunization procedure and her immune status. Based upon the reported information, the role of the vaccine as a causative factor for the events and a case of vaccination failure cannot be assessed.