Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Influenza, Influenza virus test positive, Respiratory disorder, Vaccination failure
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of vaccination failure in a adult female subject who received Flu seasonal TIV. The subject's past medical history included pregnancy (gravidity 2 and parity 1). On an unknown date, 14 days after receiving Flu seasonal TIV, the subject developed vaccination failure. Serious criteria included GSK medically significant. Additional event(s) included severe - grade 3 influenza with serious criteria of hospitalization, respiratory disorder with serious criteria of hospitalization and vaccine exposure during pregnancy. The outcome of vaccination failure was unknown. The outcome(s) of the additional event(s) included influenza (unknown), respiratory disorder (unknown) and vaccine exposure during pregnancy (unknown). The pregnancy was lost to follow up. It was unknown if the investigator considered the influenza and respiratory disorder to be related to Flu seasonal TIV. Relevant Tests: The influenza infection had been confirmed either by polymerase chain reaction, rapid influenza diagnostic case, direct fluorescence antibody test or viral culture. Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, Polymerase chain reaction result was Influenza infection absent. Additional information received: This prospective pregnancy case was reported in a literature article and it described the occurrence of a possible vaccination failure in a female patient of unspecified age who had been vaccinated with an unspecified seasonal influenza vaccine (manufacturers unknown) during pregnancy. It was unknown if the patient had received prenatal care prior to the event. According to the authors, her gravidity was 2 and her parity was 1 (type of delivery, gestation and outcome unspecified). Her expected date of delivery and date of the last menstrual period were not provided. No further information on the patient's medical history, concurrent medical conditions or concomitant medication was available. Please note that this was reported in the context of a series of 18 cases of critical ill pregnant and postpartum women who had developed severe influenza infection between 29 September 2013 and 17 May 2014, and who either required admission to intensive care or died. The cases had been reported through the Public Health Surveillance during the 2013-2014 season. On an unspecified date, at an unknown gestational age the patient received an unspecified seasonal influenza vaccine (site and administration route unspecified, batch number not provided). On an unspecified date between 23 December 2013 and February 2014, when the patient was 21 weeks pregnant and at least 2 weeks after the vaccination, she developed unspecified respiratory symptoms and was later diagnosed with influenza. She was first seen as an outpatient but later required hospitalization. The outcome of the pregnancy was unspecified. Please note that this case has been classified as a possible vaccine failure as the time to onset might be less than 21 days. This was a serious case as the patient required hospitalization. The authors reported that the influenza infection had been confirmed either by polymerase chain reaction, rapid influenza diagnostic case, direct fluorescence antibody test or viral culture. They also commented that no microbiologic evidence of a bacterial co-infection was identified. Treatment was unknown. At the time of reporting, the outcome for the event was unspecified. Please note that according to the authors all the women who survived had been discharged home at the time of writing the article. The authors did not comment on any causal relationship between the vaccine and the events. The authors concluded that "In summary, influenza remains a significant cause of morbidity and mortality in pregnant and postpartum women. Although vaccination is not 100% effective, given the higher risk of influenza complications among pregnant and postpartum women, it is incumbent that health care providers and obstetricians provide education and counseling to every pregnant woman about its benefits for both mother and neonate. Programmatic changes that address the financial and logistical barriers for health care providers to offer vaccination on-site as well as implementation of mechanisms that increase opportunities for vaccination (eg, health care provider reminder systems or standing orders) may be useful. Public health activities that alleviate concerns about safety and effectiveness (eg, education campaigns targeting pregnant women) may increase demand. Likewise, empiric antiviral treatment is recommended and should be initiated promptly, regardless of vaccination status or rapid influenza diagnostic test results. Treatment decisions, especially those involving empiric treatments, should be informed by knowledge of influenza activity in the community. Finally, most of the pregnant women in our case series had previously given birth, suggesting the possibility that other small children in the household could also be a source of transmission. Because influenza vaccination is university recommended, strategies for reducing transmission in pregnant and postpartum women should include vaccination of the entire household unit; likewise, early initiation of antiviral treatment in infected household members who may have close contact with pregnant and postpartum women should be considered". This case is 1 of the 2 valid cases reported in the same literature article (see case US2015GSK043866).