Age: 25.0
Sex: M
Vaccine: RAB
Symptoms: Muscular weakness, Paraesthesia, Respiratory failure
Clinical narrative: Initial unsolicited report received from literature on 10-Aug-2016. This case is linked to 2016SA148381, 2016SA148776, 2016SA148787, 2016SA148792, 2016SA148885, 2016SA148897, 2016SA148890 and 2016SA148892 (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 25 year old male patient, who was vaccinated with a dose RABIES (HDC) VACCINE (HDCV) (dose, batch number, expiry date route and site of administration not reported) on an unspecified date. The patient had no history of gastrointestinal or upper respiratory infections before being vaccinated. Patients other medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient had Guillain-Barre Syndrome (GBS) and presented increasing weakness, numbness, and/or tingling in extremities, difficulty walking and respiratory failure. Laboratory test was not reported. Patient required intubation and was treated with intravenous steroids and intravenous immunoglobulin. On an unspecified date, patient recovered from the events. Upon internal review, the case was considered as serious due to important medical events: Guillain-Barre Syndrome and respiratory failure. Documents held by sender: none. Sender's Comments: This case corresponds to literature article involving the patient with Guillain Barre syndrome and respiratory failure following vaccination with RABIES (HDC) VACCINE. Both the events are unlisted for RABIES (HDC) VACCINE. Details such as patient's 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.