Age: 46.0
Sex: M
Vaccine: RAB
Symptoms: Blood alcohol increased, Enuresis, Memory impairment, Muscle rupture, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of torn muscle in a 47-year-old male patient who received RABAVERT. Co-suspect products included RABAVERT. The patient's past medical history included dog bite. Concomitant products included ADVIL, BENADRYL and CLARITIN. On 26th May 2015, the patient received the 1st dose of RABAVERT (intramuscular). On an unknown date, the patient received the 5th dose of RABAVERT. In May 2015, less than a week after receiving RABAVERT and not applicable after receiving RABAVERT, the patient experienced blood alcohol increased. On 26th May 2015, the patient experienced tingling, bedwetting and sleepwalking. In October 2015, the patient experienced torn muscle (serious criteria GSK medically significant and other: As per reporter). On an unknown date, the patient experienced memory disturbance. On an unknown date, the outcome of the torn muscle was unknown and the outcome of the tingling, memory disturbance, blood alcohol increased, bedwetting and sleepwalking were recovered/resolved. The reporter considered the tingling, bedwetting and sleepwalking to be almost certainly related to RABAVERT. It was unknown if the reporter considered memory disturbance and blood alcohol increased to be related to RABAVERT. It was unknown if the reporter considered the torn muscle to be related to RABAVERT. Additional details were received as follows: The patient was bitten by a dog and was recommended to receive a rabies series. On 26th May 2015, at night (several hours after vaccination) the patient wet the bed and when he woke up realized he was in a different bed than he went to sleep in. The next night he also woke up in a different bed, but woke up before he could wet the bed. He also was experiencing tingling. The symptoms persisted and on 29th May 2015, he went in for his second shot. He spoke with the part of the clinic where he was receiving his follow-up shots of RABAVERT and he was referred to the associated emergency room department. He was observed for several hours, but it was unclear, if it was because they were concerned about his health, they were just trying to consult with experts and were waiting for call backs, or they had forgotten him. During that time they drew some blood and it was noticed that he was 50 percent legally drunk. At this point it was around 1 PM and he had not had any alcohol since before midnight. He was suffering from sleepwalking, so it was possible he drank while sleeping, but he had been at the clinic for several hours at that point. The sleepwalking and bedwetting resolved after the first week, and the tingling eventually resolved but took a little longer. He did receive 5 doses total of RABAVERT over about 1 month. He reported that his short term memory was also bad during the period of time when he received the vaccines, but it did resolve. The patient recently got an itemized receipt of his treatment and from reading the receipt it looked like he received 2.5 mL doses of RAVABERT each time. In Oct 2015, approximately 3 months after receiving 5th dose of RABAVERT, the patient had a bad muscle tear in the area where he had the dog bite. He was playing soccer at the time, but not doing anything to warrant such a tear. He also had a minor retear in the same place in Jan 2016.