Sex: U
Vaccine: FLUR4
Symptoms: Exposure during pregnancy, Foetal growth restriction, Ultrasound antenatal screen abnormal
Clinical narrative: the fetus stopped growing at seven weeks; seven weeks pregnant mother received a dose of FLUBLOK QUADRIVALENT vaccine at seven week and  fetus stopped growing from same week with no adverse event; Initial information was received on 16-Nov-2020 regarding an unsolicited valid serious case from a consumer or non-health care professional.  This case involves fetus who was stopped growing at seven weeks (foetal growth restriction) as 32-year-old pregnant mother received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] at seven weeks with no side effect (maternal exposure during pregnancy).  Data regarding this pregnancy were received prospectively.   Event occurred at between 7-10 weeks of pregnancy.  The date of last menstrual period and estimated due date was not reported.   Patient (fetus) condition at the time of vaccination to mother was not reported.   On 10-Oct-2020, the patient was exposed to a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via transplacental route via mother who was vaccinated via unknown route at left deltoid for prophylactic vaccination.  On an unknown date, the patient (fetus) stopped growing (foetal growth restriction) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant.  This was a case of Maternal exposure during pregnancy, first trimester.   It was reported, at 10 weeks, patient's mother had an ultrasound scan and the physician said that the fetus had stopped growing at 7 weeks. The physician stated that he could not tell what had caused it.  It was not reported if the patient received any corrective treatment.  At the time of reporting event outcome was unknown for foetal growth restriction and event outcome was not applicable for maternal exposure during pregnancy.   Pregnancy outcome for mother was unknown at the time of report.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.; Sender's Comments: This case involves fetus for whom  foetal growth restriction with maternal exposure during pregnancy was reported after mother's vaccination with FLUBLOK QIV. The time to onset is unknown. At 10-week patient's mother had an ultrasound and confirmed that the fetus had stop growing at 7 weeks. However, fetus condition at the time of vaccination and other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.