Age: 47.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Muscular weakness, Neurological symptom
Clinical narrative: Based on additional information received on 10-AUG-2016, this case became medically confirmed. Initial unsolicited report received from the literature on 19 March 2002. From information received via telephone at Aventis Pasteur, Inc. on 18/Mar/2002 from the patient: The patient, a 47-year-old female, was vaccinated with IMOVAX Rabies post exposure series 4-years ago for a rabid dog bite. The patient now has nerve damage and spasms. The patient has been diagnosed with GBS by neurologist. From follow-up e-mail correspondence received at Aventis Pasteur Inc. on 8/May/2002 from Aventis Pasteur SA it was made aware that correction needed to be made to the latest received date. The initial information was received on 18/Mar/2002, not 19/Mar/2002 as previously reported. Follow-up information received from the literature on 10-AUG-2016. This case was linked to 2006-03101, 2016SA148890, 2016SA148885, 2016SA148766, 2016SA148892, 2007-00117, 2016SA148897 and 2016SA148776. (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. The patient did not had a history of gastrointestinal or upper respiratory infections before being vaccinated. Other medical history and concomitant medications were not reported. On an unspecified date following the vaccination patient had Guillain-Barre Syndrome and muscle spasm. Laboratory details were not reported. Corrective treatment was not reported. This case was considered as serious by the reporter due to medical event: Guillain-Barre Syndrome. Outcome of the event was not reported. Document held by sender: none. Sender's Comments: Amount of data is not sufficient to assess this non medically confirmed case.