Age: 66.0
Sex: M
Vaccine: RAB
Symptoms: Hyperaesthesia, Immunoglobulin G4 related sclerosing disease, Irritability, Lumbar puncture, Malaise
Clinical narrative: Case number PHHY2013US135638 is an initial spontaneous report received from a consumer via vaccine adverse event reporting system (VAERS reference number: 504936) web site on 25 Nov 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 267002) on 15 May 2014. This report refers to a 66-years-old male patient. His medical history was not reported and concomitant medications included multivitamin, low dose Aspirin, tramadol and ADVIL. He was vaccinated with third dose of RABAVERT (batch number: 500011A) in the right arm on 02 Oct 2012. Within 30 seconds after vaccination, he had intense burning and hot sensation that started from his abdomen area which traveled up to his upper chest (heart and lung areas) and throat. He informed nurse of this side effect. He sat in the emergency room until the intense burning sensation diminished and then left the emergency room. Thirty minutes after the injection, he suddenly and rapidly developed major breathing problems which included forceful inhalation efforts and loud wheezing. His breathing was labored. He had head and neck ache. There was substantial tightness in muscles of the back of the neck and the sides around the head (at the forehead and sinus areas). He felt that his sinus areas were blocked. He had upper body nervousness and chills. His eyes were blood shot and throat was very painful. These side effects continued for 30 minutes and lessened by noon time. Later when he tried to eat lunch, he experienced nausea and a general feeling of illness. Shortly after that he became extremely agitated and was getting irritated to all stimuli including touch and noise. His felt that his entire body was trembling in a significant way and he had trembling of arms, hand and upper body. He became dizzy later. It was reported that the hot burning sensation in the throat and upper chest or lungs continued and his body was weak. He went to emergency room and had various brain, lung, and cervical magnetic resonance imaging (MRIs) and computerized tomograms (CTs). He also had spinal tap, blood tests for autoimmune diseases, abnormal cells and vasculitis but the results were not reported. He had blood in urine and surgery for bladder inflammation and ulcers. It was reported that he was suspected with Sjogren's syndrome and or IgG4 related sclerosing disease. He stated that he was told that these side effects were following improper injection of third dose of rabies vaccine was not reported to the CDC by the emergency room. The reporter assessed the event as life-threatening and permanently disabling. The final outcome was reported as condition unchanged. Based on the investigation performed, the QA department stated that, RABAVERT (batch number: 500011A) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow up received from the Quality Assurance Department (reference number: 267002) on 29 Nov 2013: Updated QA reference number only. Follow-up received from Quality Assurance Department (QA, reference number: 267002) on 15 May 2014: Updated batch review report.