Age: 22.0
Sex: F
Vaccine: RAB, RAB
Symptoms: Drug administered at inappropriate site, Feeling abnormal, Incorrect route of drug administration, Lethargy, Loss of consciousness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of convulsion in a 22-year-old female patient who received RABAVERT. On 25th April 2016, the patient received the 1st dose of RABAVERT (intravenous) 1 ml. On 25th April 2016, less than a minute after receiving RABAVERT, the patient experienced convulsion (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), vomiting, nausea, intramuscular formulation administered by other route and vaccine administered at inappropriate site. On 26th April 2016, the patient experienced lethargy. On 25th April 2016, the outcome of the convulsion and passed out were recovered/resolved. On an unknown date, the outcome of the vomiting, intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown and the outcome of the nausea and lethargy were recovering/resolving. The reporter considered the convulsion, passed out, vomiting, nausea and lethargy to be related to RABAVERT. Additional details were received as follows: The patient was receiving the RABAVERT for pre exposure since she worked with bats. The patient did not receive any other vaccines at time and did not take any medications on a regular basis. On 25th April 2016 at 1:40, the patient stated that, instead of receiving RABAVERT intramuscularly, she received it intravenously, which led to incorrect route of vaccination. The patient felt that, it was given in a vein because she saw blood from the site. About 1ccu of blood was drawn back when the patient was being given the vaccine. Inappropriate site of vaccine administered, was also reported as an event. However, no details were provided. The patient stated that, her primary physician, who was not from the office that administered the vaccine, believed that the product was probably given intravenously based on the symptom response and the rapid onset of symptoms. Within one to two minutes after receiving RABAVERT, the patient started to have convulsions. The patient was sitting down at the time the vaccination. The nurse in the health department described to the patient that, when the patient was having the convulsions, she passed out. The patient stated that, all she remembered was feeling like her brain was running fast forward. The patient saw snippets of past memories and heard music playing in the background. The nurse observed that, the patient did tense up and was leaning to one side. The patient did not fall and the nurse said that the episode only lasted about ten seconds. When the patient regained consciousness, the nurse explained to her what happened. Two to three minutes later, the patient had another convulsion that lasted about twenty seconds. When the patient regained consciousness, she vomited. Even after vomiting for one time, the patient felt nauseous for the next two to three hours. On the day of the day of reporting, the patient was feeling very lethargic and did not feel 100 percent that morning.