Sex: F
Vaccine: FLU3
Symptoms: Death, Exposure during pregnancy, Influenza, Influenza virus test positive, Vaccination failure
Clinical narrative: This prospective pregnancy case was reported in a literature article and described the occurrence of vaccination failure in a female subject who received Flu seasonal TIV Dresden. On an unknown date, an unknown time after receiving Flu seasonal TIV Dresden, the subject developed vaccination failure. Serious criteria included hospitalization and GSK medically significant. Additional event(s) included unknown cause of death with serious criteria of death and GSK medically significant, influenza with serious criteria of hospitalization and vaccine exposure during pregnancy. The subject was treated with TAMIFLU. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included unknown cause of death (fatal), influenza (unknown) and vaccine exposure during pregnancy (unknown). The pregnancy was lost to follow up. The reported cause of death was unknown cause of death. The investigator considered that there was a reasonable possibility that the vaccination failure and influenza may have been caused by Flu seasonal TIV Dresden. It was unknown if the investigator considered the unknown cause of death to be related to Flu seasonal TIV Dresden. Relevant Tests: Lab test was performed on unknown date. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Influenza virus test result was positive unknown. Additional information was provided. This prospective pregnancy case was reported in a literature article and described the occurrence of suspected vaccination failure in a female aged between 15 and 44-year old who was vaccinated with unspecified influenza vaccine (manufacturer unknown). The patient was the part of study that described the epidemiology and clinical outcomes associated with hospitalizations for laboratory-confirmed influenza among pregnant women during recent influenza seasons and to assess the impact of early initiation of influenza antiviral treatment. The patient was a pregnant female. (In this study, 24 out of 63 pregnant women with severe influenza infection were aged between 15 and 24 year, 31 aged between 25 and 34 year and 8 were between 35 and 44 years. 63 pregnant women with severe influenza infection 21 had the underlying medical condition of asthma, 7 had metabolic disease, 5 had cardiovascular disease (excluding hypertension), 4 had immunocompromised condition, 2 had blood disorders/hemoglobinopathy, 2 had neurologic/neuromuscular disease and 1 had renal disease. The patient's last menstrual period was on an unknown date. Estimated date of delivery was on an unknown date. No information on patient's medical history, family history or concurrent condition or concomitant medication was provided. On an unspecified date between 2010 and 2014, the patient received unspecified influenza vaccine (administration route and site unspecified; dosage unknown; batch number not provided). On an unspecified date, an unknown period after vaccination, the patient was hospitalised within 2 days of an influenza virus-positive test result. Laboratory testing for influenza virus was performed at the discretion of the clinicians providing medical care, and confirmation included a positive result of reverse transcription polymerase chain reaction analysis, rapid antigen testing, direct or indirect fluorescent antibody staining, or viral culture. Out of 63 influenza positive patients, 57 were influenza A positive, 27 were H1N1 pdm09 positive, 7 were H3N2, 6 were influenza B virus positive. Influenza associated complication among 63 pregnant patients with severe influenza infection were: 35 had pneumonia, 6 had dehydration, 12 had asthma exacerbation, 26 had sepsis/shock, 25 had respiratory failure, 9 had acute respiratory distress syndrome, 7 had acute renal failure and 4 had pulmonary embolism. This case has been considered as suspected vaccination failure as time to onset was unknown. This case was considered serious due to hospitalisation. The patient was treated with TAMIFLU. The outcome of the pregnancy was lost to follow-up. On an unspecified date, the patient died. (In this study, 3 out of 4 fatal cases were treated more than 2 days after illness onset including one who was admitted within 2 days of illness onset, the date of illness onset was unknown for 1 patient. 3 of the deaths involved women less than 35 years of age with no underlying medical conditions). It was unknown if the autopsy was done. The cause of death was unknown. The authors did not comment on the relationship between influenza infection and unspecified influenza vaccine. The authors concluded that "Pregnant women are at risk of influenza complications during seasonal influenza. Influenza virus infection during pregnancy continues to be associated with maternal and infant morbidity, including ICU admission, preterm birth, fetal loss, and maternal death. All pregnant women should receive annual influenza vaccination to prevent influenza and associated complications for themselves and their infants. Early initiation of antiviral treatment may reduce hospital length of stay, particularly among women who have a more severe influenza presentation. When influenza is suspected among pregnant women, physicians should initiate antiviral treatment early, without waiting for laboratory test results."