Sex: U
Vaccine: FLU4
Symptoms: Congenital anomaly, Foetal exposure during pregnancy
Clinical narrative: This retrospective pregnancy case was reported in a literature article and described the occurrence of birth defects in a infant. The mother received Flu  Seasonal  TIV  Dresden.  The pregnancy resulted in a live neonate with a congenital anomaly. The infant was diagnosed with birth defects. Serious criteria included congenital anomaly. Additional event(s) included maternal vaccine exposure. The outcome of birth defects was unknown. The outcome(s) of the additional event(s) included maternal vaccine exposure (unknown). The investigator that there was a reasonable possibility that the birth defects may have been caused by Flu  Seasonal  TIV  Dresden.  Additional information was provided. This retrospective pregnancy case was reported in a literature article and described the occurrence of unspecified major birth defects in an infant of unspecified gender whose mother was vaccinated with unspecified seasonal in  influenza vaccine (manufacturer unknown). This case corresponds to table e1 (supplementary) of this literature article. The patient was a part of study to evaluate the fetal risk and relative safety of the seasonal influenza vaccine overall and secondarily season by season from 2010-2014 using data from the Vaccines and Medications in Pregnancy Surveillance System (VAMPSS), a research program developed specifically to evaluate medications and vaccines used by pregnant women. No information on patient's medical or family history or concurrent condition or concomitant medication was provided. On an unspecified date between 2013 and 2014, the patient's mother received unspecified seasonal influenza vaccine (administration and site unspecified; dosage unknown; batch number not provided) between LMP-DOC (in this study, LMP-DOC is defined as exposure between 1st day of last menstrual period and estimated date of conception. Vaccine year started from August 1st of each year). Subsequently, the foetus was exposed to the vaccine. On an unspecified date, an unknown period after vaccination exposure, the patient was born with unspecified major birth defects (in this study, major birth defects included absence of testis, Prader-Willi Syndrome-  includes atrial septal defect, laryngomalacia, bilateral undescended testicle, bilateral clubfoot, small penis, microcephaly, congenital hydronephrosis, postaxial polydactyly, Type B, bilateral). This case was considered serious due to congenital abnormality. Treatment was unknown. The outcome of the event was unknown. The authors did not comment on the relationship between unspecified major birth defects and unspecified seasonal influenza vaccine. The authors concluded that "Combining the 2010-2014 influenza seasons, we found a moderately elevated Relative Risks for major birth defects overall, but no evidence of a specific pattern; 95% confidence intervals included 1, and this finding could be due to chance. In the combined seasons, we found no meaningful evidence of an increased risk for   [Due to memory limitations, the remainder of this text could not be compared.]   spontaneous abortion or preterm delivery following exposure to the seasonal influenza vaccine." This is 1 of the 5 valid cases from the same literature article.