Age: 16.0
Sex: F
Vaccine: RAB
Symptoms: Asthenia, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Paraesthesia
Clinical narrative: Initial unsolicited report received from the literature on 10 August 2016. This case is linked with 2016SA148381, 2016SA148766, 2016SA148776, 2016SA148792, 2016SA148885 (same literature). The following is verbatim from the article: 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 a 16 years old female patient, who was vaccinated with a dose IMOVAX rabies (dose, batch number, expiry date route and site of administration not reported) on an unspecified date. The patient had medical history of vomiting and diarrhea 1 week before receiving HDCV. Concomitant medications were not reported. On an unspecified date, post vaccination, the patient had Guillain-Barre Syndrome (GBS) and presented with difficulty in walking, increasing weakness, tingling in extremities, and, numbness. Laboratory tests were not reported. Corrective treatment was not reported. The outcome of the events was not reported. Upon internal review, the case was considered as serious due to important medical event: Guillain-Barre Syndrome. Documents held by sender: none. Sender's Comments: This is poorly documented case as patient presented with multiple symptoms and diagnosed with Guillain Barre syndrome (GBS) following IMOVAX RABIES vaccine. Time to onset is unknown, as GBS is often preceded by an infection, the most frequent being Campylobacter jejuni, in this patient has history of vomiting and diarrhea 1 week prior vaccination which could the triggering factor, complementary medical history, concomitant medication history, results of investigations (cytoalbuminologic dissociation, EMG, NCS, MRI) and etiological work-up (infection) are needed to assess the case. Based on available information role of vaccine cannot be assessed.