Sex: F
Vaccine: FLUX, FLUX
Symptoms: Influenza virus test positive, Lower respiratory tract infection, Mycoplasma test negative, Oropharyngeal pain, Polymerase chain reaction positive
Clinical narrative: This case was reported in a literature article and described the occurrence of suspected vaccination failure in a adult female subject who received Seasonal influenza vaccine for prophylaxis. Concurrent medical conditions included pregnancy. On an unknown date, unknown after receiving Flu Seasonal QIV Dresden, the subject developed vaccination failure. Serious criteria included GSK medically significant. Additional event(s) included influenza and lower respiratory tract infection with serious criteria of GSK medically significant. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included influenza (unknown) and lower respiratory tract infection (unknown). The investigator considered that there was a reasonable possibility that the vaccination failure, influenza and lower respiratory tract infection may have been caused by Flu Seasonal QIV Dresden. Relevant Tests: Laboratory tests were performed on unspecified dates between 1 October 2015 and 10 May 2016 . The patient's nasopharyngeal secretions were collected by a combined throat and nasal swab and evaluated for respiratory viruses by real-time reverse transcription-polymerase chain reaction. The patient was diagnosed as influenza virus positive (type unspecified). Diagnostic results (unless otherwise stated, normal values were not provided):  On an unknown date, Influenza virus test result was positive unknown. On an unknown date, Polymerase chain reaction result was see text unknown. Additional information was provided. This case was reported in a literature and described the suspected vaccination failure in a pregnant female aged equal to or more than 18 years who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown) for prophylaxis. The patient was part of study with the objective to determine the frequency of acute respiratory illness (ARI) due to respiratory viruses and the associated clinical outcomes during pregnancy. Patients were enrolled at an outpatient obstetric (for routine and high-risk obstetric care) and gynaecologic clinic, between 1 October and 10 May to coincide with the 2015-2016 respiratory virus season. The patient was pregnant [2nd (13-27 weeks of gestation) or 3rd trimester (more than 27 weeks of gestation)] and was otherwise healthy. No information on patient's medical or family history or concomitant medication was provided. On an unspecified date, the patient received unspecified seasonal influenza vaccine (administration route and site unspecified; dosage unknown, batch number not provided). The age of vaccination was not provided. It was unknown whether vaccination was given during pregnancy or not. On an unspecified date between 1 October 2015 and 10 May 2016 (2015-2016, 7- month season of respiratory virus season) in her 2nd or 3rd trimester of pregnancy during the regular prenatal and sick visits at an outpatient obstetric and gynaecologic clinic, an unknown period after vaccination, the patient had self-reported symptoms of acute respiratory infection (rhinorrhoea, sore throat, cough, shortness of breath, or wheezing). Subsequently, equal to or less than 7 days from the symptom onset, the patient presented to the clinic. The patient was found to have acute lower respiratory tract illness (ALRTI). [In this study, ALRTI was defined as the presence of any of the following: difficulty breathing or shortness of breath, wheezing, or cyanosis]. The patient's nasopharyngeal secretions were collected by a combined throat and nasal swab and evaluated for respiratory viruses by real-time reverse transcription-polymerase chain reaction (RT-PCR). [ In this study, all real-time RT-PCR assays were 1-step, singleplex assays were performed to detect genomic material of the following respiratory pathogens: Respiratory syncytial virus (RSV) A and B; Human rhinovirus (HRV); influenza virus types A and B; human coronaviruses (HCoVs) NL-63, HKU1, OC43, and 229E; parainfluenza virus (PIV) types 1, 2, and 3; human  metapneumovirus (HMPV); adenovirus; bocavirus; Mycoplasma pneumoniae; and Bordetella pertussis]. The patient was diagnosed as influenza virus positive (type unspecified). This case has been considered as suspected vaccination failure being full schedule and the time to onset was unknown. This case has been considered as serious due to suspected vaccination failure. The treatment was unknown. The outcome of the event was not provided. The outcome of the pregnancy was lost to follow up. The author did not comment on relationship between the event of influenza infection and unspecified seasonal influenza vaccine. The author concluded "respiratory viruses were frequently detected among pregnant women with ARI, over one third of whom had symptoms consistent with ALRTI. By not restricting the inclusion criteria to influenza-like illness, we were able to capture a broader range of respiratory viruses and their associated respiratory illnesses. Although HRV was the most commonly detected respiratory virus, RSV or influenza virus were the most common viral pathogens among cases with ALRTI with fever. History of allergies might be a predisposing factor for virus-induced wheezing during pregnancy. Despite the avail-ability of a seasonal influenza vaccine, maternal vaccine coverage in this population was low. A maternal RSV vaccine is currently in evaluation and would theoretically prevent illness in both infants and mothers. However, vaccine coverage in this vulnerable population must improve for these maternal vaccines to be truly effective." This is 1 of 2 valid cases reported in this literature article. Lab Comments: Laboratory tests were performed on unspecified dates between 1 October 2015 and 10 May 2016 . The patient's nasopharyngeal secretions were collected by a combined throat and nasal swab and evaluated for respiratory viruses by real-time reverse transcription-polymerase chain reaction. The patient was diagnosed as influenza virus positive (type unspecified).