Sex: F
Vaccine: RAB
Symptoms: Exposure during pregnancy, Unevaluable event
Clinical narrative: Initial unsolicited report received from the literature on 10-AUG-2016. This case was linked to 2016SA148381, 2016SA148766, 2016SA148776, 2016SA148787 and 2016SA148792. (Same literature). The following is verbatim from the article: Abstract: Background: In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use. Objective: To assess adverse events (AEs) after HDCV reported to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. Methods: We searched VAERS for reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barre© syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using Med-DRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. Results: VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. Conclusions: This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. This case involves four female patients (unknown age) who were vaccinated with a dose of RABIES (HDC) VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date while she was pregnant. The patients last menstrual period date was not reported and pregnancy trimester for three patient was reported as first trimester and for one patient pregnancy trimester was not reported. The medical history and concomitant medications of patients were not reported. On an unspecified date, following the vaccination, two patient had spontaneous abortion, one patient had non-anaphylaxis allergic reaction and one patient had syncope. Lab data and corrective treatment were not reported. The outcome of the events was not reported. Upon internal review the case was considered as serious because of important medical event: spontaneous abortion and non-anaphylaxis allergic reaction. Documents held by sender: none. Sender's Comments: This case was extracted from a literature article involving four patients who had spontaneous abortion following vaccination with RABIES (HDC) VACCINE. As per the available information, one of the four patients also experienced non-anaphylaxis allergic reaction. It is unclear whether the vaccine administered was a pre-exposure or a post exposure dose. RABIES (HDC) VACCINE, however is not recommended during pregnancy as a pre-exposure dose. Details such as patients relevant medical history, prior vaccination history and tolerance, etc. are needed to further assess the role of vaccine. Based on available information, no conclusion can be drawn.