Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Respiratory disorder, Rhinorrhoea, Seizure, Spinal cord infection
Clinical narrative: This spontaneous report was received from a consumer (patient's mother), via a video which was published online and via Sanofi Pasteur MSD, and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. The reporting mother stated that her son was a typical boy when he was born. He was happy, healthy and walk-in talking. On an unknown date approximately in 1997, the patient was vaccinated with varicella virus vaccine live (manufacturer unknown) (trade name, dose, route of administration, anatomical location, lot # and expiration date were not reported). The patient's mother reported that her son was developing normally (reported as "everything was on time, everything was great") and then he received his varicella virus vaccine live (manufacturer unknown) and things really started to deteriorate from that moment (unknown date around Easter 1997). She reported that one day he woke up and he was perfectly fine, but when he went to bed and he woke up the next day (first day after the vaccination) he was not right. He had a running fever and a little snotty nose. Additionally, he was mainly reverted back to crawling and he refused to stay and walk. The patient's mother also noticed that throughout the all day, he did not speak. Therefore, his grandfather took him to the suite (which was one of his favorite things of the today) and put him on the horse on the swing, when the patient just fell off "like a dead rock", straight to the ground. His mother reported, that he had no equilibrium in his body, no self being reaction to "catch the silver and stop from falling". As a result, she took him to the hospital, where she received response that the patient "was just having a reaction to the old men". Since coming back to home, the patient was very cranky and just cried. On the next day, the "things" got a little worse, that he got to the point where he could not even sit, so his mother took him back to the doctors, where she was told that it would take a few weeks to pass, but there was nothing to worry about and they had to come back home again. Over the next couple of days (reported also "in a matter of four days"), things continued to get worse and her son went into a near vegetative state (also reported as "her child deteriorated"). The patient's mother took him to different specialists. They spent three months at the intensive care units (ICU) (since an unknown date in 1997), where many tests were performed (results not provided), but anyone did not came up with any diagnosis, which would made any sense. Finally, her son was transferred from the hospital to a different ICU and the doctor there was able to figure out what was going on with the patient exactly. The physician stated that the reporter's son had been suffering from varicella virus vaccine live (manufacturer unknown). He explained that something in the vaccine counteracted with something in his genetics and caused immune system response, which in result caused that the infection got into the spinal cord and "started eating away all the way up to the brain and ate away at some of the tissue that left the patient with scar tissue". The reporting mother stated, that her son was injured by varicella virus vaccine live (manufacturer unknown) (also reported as "chickenpox vaccine") and robbed of many opportunities in life. Since then, his everyday life was different challenge, involving a seizure problems, respiratory problems or feeding issues (onset dates were not reported). The patient was not that walk-in, talking, happy bully anymore. The outcome of aforementioned events was unknown at the time of the report. The reporter considered the events to be related to varicella virus vaccine live (manufacturer unknown) as she was sure that it was an adverse reaction on the vaccine and she was not aware that something like this could happen as a side effect. Upon internal review, the events of central nervous system infection and seizures were considered to be medically significant, whereas the event of child deteriorated/went into near vegetative state to be serious as disabling and medically significant. Additional information is not expected as no contact details were provided.