Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Gastroenteritis norovirus, Gestational diabetes, Influenza
Clinical narrative: This is a spontaneous case, initially received from other non-health professional on 03-Oct-2018, concerns a 33-year-old, adult pregnant patient. The patient's historical drug included unspecified oral contraceptive. The obstetrical history of patient included one previous pregnancy. There was no stillbirth or miscarriage, birth defect or congenital anomaly occurred in previous pregnancy. The patient reported that during her last pregnancy, she did not receive any flu vaccine but developed flu on 09-Dec-2016 and recovered on 11-Jan-2017 with hospitalization. The patient also developed pre-eclampsia on 09-Jan-2017 with unspecified inflammatory condition. The patient had an emergency caesarean section (reported as C-section) on 18-Feb-2017, at 32 weeks gestational age. This led to the baby's birth 8 weeks ahead of predicted date. The patient had not taken any oral contraceptive prior to the current pregnancy. The patient had no paternal medical history (hereditary disease) and no medication was received by father prior to conception. The patient's current condition included hypothyroidism (since an unspecified date in Jun-2016). The patient's concomitant medications included levothyroxine for hypothyroidism and Prenatal vitamins and Baby aspirin (acetylsalicylic acid). The patient's last menstrual date (LMP) date was 27-Jul-2018. This was the patient's second pregnancy. On 01-Oct-2018, at gestational age of 9 weeks, the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF40608 and expiry date: 30-Jun-2019] (explicitly coded as vaccine exposure during pregnancy) for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. On 29-Dec-2018, after vaccination, the patient went to emergency room (ER) with flu which lasted about 8 weeks. The patient also developed borderline diabetes (gestational) which was controlled through diet. On an unspecified date during pregnancy, the patient also contracted norovirus but had no pre-eclampsia. The patient stopped taking precautionary (prophylaxis) baby aspirin at 36 weeks, as the next few weeks were critical. The patient had recovered from the event flu. The outcome of the event gestational diabetes was not recovered. The patient's estimated delivery date (EDD) was reported as 02-May-2019. The reporter assessed the case as non-serious. Non-significant follow up received from other non-health professional on 01-Feb-2019: It was reported that the patient was not enrolled in the registry. The Registry has exhausted its attempt with the patient. No further follow-up will be conducted. Hence no changes were made in narrative. Follow up report received from the reporter on 02-Apr-2019: Added start date and stop date of historical condition (flu), historical procedure emergency C-section and start date of pre-eclampsia was added. The concomitant medication (baby aspirin) was added in the product tab. The events (flu, gastroenteritis norovirus and gestational diabetes) were added. The narrative was amended accordingly. Reporter's Comments: A 33-year-old, pregnant patient was administered AFLURIA QUADRIVALENT at 9 weeks of gestation (considered as vaccine exposure during pregnancy). The patient experienced borderline gestational diabetes, flu (influenza) and norovirus infection, unspecified period post vaccination. Due to the lack of information important for the causality assessment, such as onset latency between the vaccination and reported events, company assessed the causality of the events borderline gestational diabetes and flu as unassessable. The event Norovirus infection assessed as not related to inactivated suspect vaccine, considering the infectious (viral) aetiology of the event. The company assessed the causality of the event vaccine exposure during pregnancy as not related to the suspect vaccine considering the intended use of the vaccine. The company assessed the case as serious (medically significant).