Sex: F
Vaccine: RAB, RAB
Symptoms: Hypotension, Muscle twitching, Nervous system disorder, Product administered at inappropriate site, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of breathing arrested in a female patient who received RABAVERT for prophylaxis. The patient's past medical history included animal bite. Concurrent medical conditions included blood pressure high. On an unknown date, the patient received the 2nd dose of RABAVERT. On an unknown date, unknown after receiving RABAVERT, the patient experienced breathing arrested (serious criteria GSK medically significant), hives, difficulty breathing, neurological disorder nos, twitching facial, burning foot, low blood pressure, burning in eyes, burn of unspecified degree of foot and vaccine administered at inappropriate site. On an unknown date, the outcome of the breathing arrested and difficulty breathing were recovered/resolved and the outcome of the hives was not recovered/not resolved and the outcome of the neurological disorder nos, twitching facial, burning foot, low blood pressure, burning in eyes, burn of unspecified degree of foot and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the breathing arrested, hives, difficulty breathing, neurological disorder nos, twitching facial, burning foot, low blood pressure, burning in eyes, burn of unspecified degree of foot and vaccine administered at inappropriate site to be related to RABAVERT. Additional details were reported as follows: The patient was tall and had thick thighs. The patient recently experienced what she thought was a bat bite and received two injections of RABAVERT at the emergency room, both administered in her thigh. After receiving 2nd shot, the patient had breathing problems and she stopped breathing for a period of time. She also had very low blood pressure and burning eyes and had to be kept at the emergency room for several hours for observation. The patient went to the emergency room at approximately 7 PM and went home around 4 AM. The patient developed hives from head to toe and still had the hives. She also had neurological problems for a couple weeks after the vaccine. When she smiled her face would twitch, and the bottom of her feet burned. The patient was not sure all of the problems were related to RABAVERT. Around the same time this was happening, her daughter had strep throat and was later diagnosed with scarlet fever and had a rash similar the reporter's. Strep throat and other illnesses were going through her household. Due to the fact that the injection was given in her thigh, the emergency room recommended she get a titer to check if the vaccine was effective. The titer came back with an antibody lever greater than or equal to 0.5 and said it was acceptable level. This case has been linked with case US2018GSK121404 (same patient for 1st dose), reported by the same reporter. The reporter said that she had reported these adverse events previously but duplicate case could not be found. Lab Comments: Lab test for rabies antibodies was done on an unknown date and the antibody titre was found to be greater than or equal to 5 and it was acceptable level.