Sex: F
Vaccine: FLUX, TDAP
Symptoms: Abortion spontaneous, Exposure during pregnancy, Ultrasound antenatal screen
Clinical narrative: Spontaneous abortion; Vaccine Exposure During Pregnancy (trimester unknown); This retrospective pregnancy case was reported in a literature article and described the occurrence of spontaneous abortion in a adult female patient who received Flu unspecified (Flu vaccine) for prophylaxis. (Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   Previously administered products included unspecified influenza vaccine (in the previous season).  On an unknown date, the patient received Flu vaccine at an unknown dose and Tdap Vaccine at an unknown dose. On an unknown date, less than 6 months after receiving Flu vaccine and Tdap Vaccine, the patient experienced spontaneous abortion (serious criteria GSK medically significant) and vaccine exposure during pregnancy. On an unknown date, the outcome of the spontaneous abortion and vaccine exposure during pregnancy were unknown. The pregnancy ended in a spontaneous abortion at less than 22 weeks gestation with no apparent congenital anomaly present.   The reporter considered the spontaneous abortion to be related to Flu vaccine and Tdap Vaccine.  Additional details were provided as follows: This retrospective pregnancy case was reported in a literature article and described the spontaneous abortion (SAB)' in a female patient aged between 18 and 44 years who was vaccinated with unspecified seasonal inactivated influenza vaccine (IIV) and unspecified tetanus, diphtheria and pertussis (Tdap) vaccine (manufacturer unknown for both) during pregnancy (trimester unknown) for prophylaxis. This case corresponds to table 1 in this literature article. The patient was a part of case-control study that estimated the association between IIV administered in three recent influenza seasons (2012-13, 2013-14, 2014-15) and SAB among women who were and were not vaccinated in the previous influenza season in the Vaccine Safety Datalink (VSD). [In this study, for the purposes of this report, it was referred to the VSD study of women pregnant in the 2005-06 or 2006-07 influenza seasons as IIV-SAB-1, the VSD study of women pregnant in the 2010-11 and 2011-12 influenza seasons as IIV-SAB-2, and the current VSD study of women pregnant in the 2012-13, 2013-14, and 2014-15 influenza seasons as IIV-SAB-3. In IIV-SAB-3, the women who were pregnant during the 2012-13, 2013-14, or 2014-15 influenza seasons were included. In this study, 21 patients had history of type 1 or 2 diabetes, 83 patients had history of asthma, 31 had history of pre-existing hypertension, 5 patients had hashimoto's thyroiditis, 2 patients had systemic lupus erythematosus, and 2 patients had multiple sclerosis. No patient had history of antiphospholipid syndrome and celiac disease. Out of 627 cases vaccinated in previous season: 346 were, 41 were, 4 were, 8 were native, 124 were and 36 were of other race. The ethnicity of 627 cases were: 428 were and 199 were. The occupation of 627 cases were: 122 were healthcare, 53 were education, 290 were of unspecified other occupation and occupation of 162 patients were unknown. 445 patients had history of 1 or more births (parity) and 513 patients had history of gravidity. 217 patients had history of 1 or more than 1 previous SAB and 74 patients had history of 2 or more than 2 previous SAB. 49 patients had history of alcohol during pregnancy and 21 patients had history of smoking during pregnancy]. The patient's pregnancy was confirmed using information abstracted from the medical record: obstetric ultrasound, clinic or hospital-based assay (e.g., human chorionic gonadotropin level), patient-reported test, and/or physician diagnosis. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unspecified. No information on patient's family history or concurrent condition was provided.  On an unspecified date between 1 August and 30 June during unspecified influenza season (2012-13 or 2013-14 or 2014-15), the patient received unspecified IIV and concomitantly received unspecified Tdap vaccine (administration route and site unspecified; dosages unknown; batch number not provided for both) during pregnancy (trimester unknown). It was reported that the patient had also received unspecified influenza vaccine in the previous season. [In this study, women were considered exposed only if the vaccine was administered before the reference date; it was classified women receiving influenza vaccines on or after the reference date as unexposed in all analyses. Less than 3% of IIV administered to the study population was quadrivalent; therefore, it did not differentiate trivalent and quadrivalent IIV exposures in the analysis]. The age at vaccination was not provided.  On an unspecified dated between 1 September and 28 April during unspecified influenza season (2012-13 or 2013-14 or 2014-15), between 6 and less than 20 weeks of gestation and an unknown period after the vaccination, the patient had spontaneous abortion (SAB). [In this study, the SAB was confirmed by ultrasound or by clinical diagnosis in the absence of ultrasound results. The SAB date was based on the earliest clinical diagnosis for women without ultrasound results. The SAB date was defined as the LMP date plus the estimated gestational age at the time of the SAB]. The authors commented, "In the context of safety, the results of this study lend support to the Practices recommendation for IIV at any time during pregnancy. It found no clear evidence of an association between IIV and SAB; reasons for the apparent discrepancy between IIV-SAB-2 and IIV-SAB-3 are unknown. There was no association found between SAB and influenza vaccination in the other risk windows, or when vaccine receipt was analyzed relative to date of conception." The authors concluded, "During these seasons it was found no association between IIV and SAB, including among women vaccinated in the previous season. These findings lend support to current recommendations for influenza vaccination at any time during pregnancy, including the first trimester." This is 1 of the 2 valid cases reported in the same literature article.      Lab Comments: Lab test done on an unknown date. The patient's pregnancy was confirmed using information abstracted from the medical record: obstetric ultrasound, clinic or hospital-based assay (e.g., human chorionic gonadotropin level), patient-reported test, and/or physician diagnosis.