Your Health. Your Family. Your Choice.
Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: Cardiogenic Shock; Bronchopneumonic outbreak [in interstitial lung disease]; [Bronchopneumonic outbreak] in interstitial lung disease; Sopor; Influenza A H3N2; Dry cough; Dyspnoea; Inefficacy of flu vaccination; Positive results, for influence A H3N2; This is a spontaneous case from country, reported by a physician to Agency (regulatory reference number: IT-MINISAL02-536805) and initially retrieved on 18-Mar-2019, concerning a 78-year-old, elderly female patient. On 10-Dec-2018, the patient was administered Fluad (TIV) [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, dose: 0.5 ml, route of administration: intramuscular, batch number: 0942A1A, anatomical location and expiry date: not reported] for vaccination. On 26-Feb-2019, 2 months and 16 days after vaccination, the patient experienced dry cough, dyspnoea and sopor. On an unspecified date, the patient was hospitalized. During hospitalization, polymerase chain reaction (PCR) on nasal buffer was performed and the results were positive for influenza A H3N2 (reported as vaccination failure). On 28-Feb-2019, the patient experienced bronchopneumonia outbreak in interstitial lung disease. On 04-Mar-2019, the patient was transferred to a different hospital. On 08-Mar-2019, the patient experienced cardiogenic shock and died. The reporter assessed the case as serious (death and hospitalization).; Reporter''s Comments: A 78-year-old female patient experienced dry cough, dyspnoea, sopor and was diagnosed to have influenza, 2 months and 16 days after Fluad (TIV) vaccination (coded to H3N2 influenza and vaccination failure). The patient subsequently experienced bronchopneumonia outbreak in interstitial lung disease, cardiogenic shock and died. Considering the fact that vaccine needs minimum 2-3 weeks to provide immune protection against influenza, vaccination failure and causal role of suspect vaccine for the fatal event of H3N2 influenza cannot be ruled out and were assessed as related to suspect vaccine. Despite temporal association between vaccination and fatal events of bronchopneumonia outbreak in interstitial lung disease and cardiogenic shock, the clinical course suggests the reported influenza and its complications as a more plausible explanation for the events. Hence, the company assessed the causality as not related to suspect vaccine.The company assessed the events cardiogenic Shock, H3N2 influenza and vaccination failure as serious (medically significant).; Reported Cause(s) of Death: Cardiogenic shock; Sopor; Bronchopneumonic outbreak; Interstitial lung disease; Influenza A H3N2; Inefficacy of flu vaccination
Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166