Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Testicular injury, Testicular swelling, Unresponsive to stimuli, Varicella post vaccine, Varicella virus test negative
Clinical narrative: Information has been received from a registered nurse concerning her 32 month old healthy and strong son with no drug allergies who on 11-JUL-2000 was vaccinated with a dose of VARIVAX (Merck) (lot number and route of administration not reported). The nurse reported that her son developed 3-4 chicken pox lesions several days after he received VARIVAX (Merck). The nurse also reported that her son began to "dig at" his left forearm after he received VARIVAX (Merck) and he often caused his forearm to bleed. The nurse reported that her son continued to scratch and "dig at" his left forearm until her son was 9 years old. Nurse believed this was caused by post herpetic neuralgia. The nurse also reported a second son who experienced an adverse event following vaccination with VARIVAX (Merck) (WAES1103USA01246). On 11-FEB-2011 the patient developed chicken pox again with lesions on both sides of his body, he was almost recovered from his lesion when he "dropped" and had a seizure. At the time of the report, the patient has had seizures for the past 2 weeks, over 20 seizures per day, they were not convulsive and not epileptic seizures (no electrical activity). His eyes rolled back, he became limp, his upper body jerked and his eyes fluttered. The patient was partially aware and had some memory of his seizures. The patient had been in the emergency room 5 times and the patient was hospitalized for 2 days. The hospital physicians did not think he was having seizures, but the nurse who was reporting this about her son thought he was having seizures. He was treated in the hospital with fluids. The patient's cerebral spinal fluid pressure was high and he had increased protein in his cerebral spinal fluid, his lymph nodes behind his right ear were grossly enlarged and behind his left ear were mildly enlarged. The nurse gave her son vitamins (unspecified), ZYRTEC, BENADRYL and "citrus". Her son developed 4 new lesions recently and when that happened his seizures increased and his lymph nodes enlarged again. He had one lesion on his forearm surrounded by what looked like cellulitis. The nurse applied ice and charcoal poultice. The cellulitis was gone later that evening. A week ago (approximately 28-Feb-2011) the patient's left lower leg had "flames of fire" going up his blood vessels on his shin and her son said it felt numb in that area. The redness and numbness were gone a day later (approximately 01-March-2011). Yesterday on 06-March-2011, the patient had "flames of fire" on the top of his left thigh. Follow-up information was received via e-mail from the nurse indicating that her son's CSF sample was sent to a lab. The nurse stated that on 16-MAR-2011, her son had a new spot and there was one on his chest that was just developing a small pustule. These spots were much smaller and very latent in his progression of disease so she was not sure if the lesions would be any good. The nurse mentioned that she had an appointment to collect a specimen off one or both of these. Follow-up information was received via telephone call from the registered nurse concerning her son who lived for 7 years with his grandfather who had chronic shingles in 2002 and 2004 and was treated with acyclovir, but had been fairly stable since then. The patient's grandfather not live in the same house with them but rather live in a separate house but were constantly in and out their home. The patient had regular and close contact with him. The registered nurse stated that her son, prior to vaccination with VARIVAX (Merck), was a normal, healthy child with no significant medical history. In July 2000, her son developed 3-4 varicella like lesions post vaccination with VARIVAX (Merck), from which recovered. However, several weeks post vaccination with VARIVAX (Merck), and after the lesions resolved, her son started to "dig" and scratch at an area on his left forearm. This continued off and on until he was about 9 years old. When the registered nurse asked why her son continued to scratch this area of his arm, he told his mother that his left forearm "itched and burned badly" deep inside his arm, but not on the surface. The registered nurse also observed that the scratching seemed to increase during time of stress. That digging and scratching continued off and on until her son was 9 years old. At the age of nine and sometime in 2006, the scratching and digging at the left forearm stopped completely. The registered nurse stated that in the years post vaccination with VARIVAX (Merck) and until December 2010, her son was otherwise a normal, healthy, athletic 13 year old who was 6 feet tall and weighed 174 pounds. Other than the scratching and digging at the left forearm in previous years, her son had no other significant medical issues or problems other than several episodes of swimmer's ear. Her son was very physically active and fit, and was a competitive swimmer who trained regularly. On approximately 15-DEC-2010, her son was kicked in the groin while playing on the playground and sustained a significant testicular injury with extensive bruising and swelling. Her son was on bed rest for 2 weeks but subsequently recovered. Her son did not require surgery or other intervention; however, he would return to the physician for follow-up in May 2011. Her son did well until 31-JAN-2011, when her son sustained a concussion from a snowboarding accident. Her son was not hospitalized nor did he require other medical/surgical intervention; however he began to see a neurologist (concussion specialist) once a week for follow-up, and was not allowed to train or swim competitively for several weeks. On 08-FEB-2011, her son tripped at home and hit his head again, and subsequently became lethargic. He was taken to the emergency room and was diagnosed with another concussion as well as a post-concussion syndrome; a computed axial tomography (CT) scan of the brain was otherwise normal. Again, no further medical or other intervention was required, and her son was not admitted to the hospital. Subsequently, her son recovered from the concussion. On 11-FEB-2011, her son developed vomiting and a fever of 100.5. On the following day on 12-FEB-2011, her son vomited throughout the day and also had a syncopal episode in the evening. Her son was taken to the emergency room for IV hydration, and was subsequently found to be having 13-15 premature ventricular contractions (PVCs) per minute on his electrocardiogram (EKG), with a possible left atrial abnormality and a possible right bundle branch block. However, her son was not admitted to the hospital and did not receive any other intervention. The registered nurse stated that at the time "nothing much" was made of the cardiac issues and her son was sent home. After her son got home from the hospital, the registered nurse noticed that her son had several "spots" or lesions resembling chickenpox. By 13-FEB-2011, her son had approximately 80 to 100 lesions on his chest and back. On 14-FEB-2011, the registered nurse took her son to see the physician, who diagnosed her son with chickenpox. Her son did not require any treatment. The physician offered the option of treatment with acyclovir; however, the registered nurse refused the treatment as she felt if he had a good case of chickenpox in addition to his prior vaccination with VARIVAX (Merck), that he would certainly be well-protected and immune to future chickenpox or varicella-related problems. The registered nurse stated that around this time -i.e. mid-February 2011-, her son began to start "digging" and scratching again at the same area on his left forearm which her son had done in prior years. Late in the week of 14-FEB-2011, her son saw the neurologist for "impact testing" in follow-up to his previous concussions. This testing showed his scores on balance and impulse control had worsened. However, on 18-FEB-2011, the physician and the concussion specialist felt it was medically safe for her son to fly to compete in a swimming meet. Her son's chickenpox lesions had crusted over and were healing. On 20-FEB-2011, he was very tired but the mother attributed it to the flight and activities of the day before. The same day they went to shopping and while in store, her son "dropped to the floor" with a seizure. The registered nurse stated that her son did not have tonic-clonic movements, but he fell to the floor, his eyes rolled back in his head, his eyelids were fluttering, his upper body was jerking and her son was unresponsive to his name - his eyes were open but he did not respond. Her son was taken to the emergency room and was placed in an isolation room due to his crusted chickenpox lesions. Her son had a CT scan of the brain, which was normal. Subsequently, her son was sent home - her son was not admitted to the hospital and had no other intervention - her son was instructed to follow-up with his neurologist when he returned home. The registered nurse stated that over the next 2-3 days, her son had several more similar episodes -i.e. her son would "go out" for several minutes or more and would be unresponsive, but with his eyes open. On 28-FEB-2011, her son had another seizure but this time with full body stiffness. Her son was taken to the emergency room and was admitted to the hospital due to the seizure, and in order to have a 24-hour electroencephalogram (EEG). A lumbar puncture was also done and showed an "elevated pressure of 333". The 24-hour EEG showed no "electrical" issue or indication of epilepsy. While hospitalized, his EKG showed bigeminy and trigeminy, as well as bradycardia (i.e. his heart rate was in the 40's, which they attributed to his being an athlete and felt was a normal finding for him rather than to anything of concern). Her son also had several syncopal episodes when going from the lying down to sitting up position; however, no other diagnoses were made other than the conversion disorder, and no cardiac issue was identified. A consulting cardiologist felt there was no connection between the seizures and the syncopal episodes, and there was nothing of note they could find in terms of any cardiac issues. The cardiac findings and syncopal episodes did not prolong his hospitalization. No diagnoses were made and her son was discharged to home on 01-MAR-2011 after and overnight hospital stay for the 24-hour EEG. Subsequently, her son saw a neurologist who, after reviewing the 24-hour EEG and in light of his prior history, diagnosed her son with a conversion disorder (i.e. pseudoseizures), as no electrical or other physiologic etiologies for the seizures were identified. Her son was not, nor never had been, placed on any anti-seizure medications. The registered nurse also took her son to a pediatric cardiologist due to some of the recent EKG findings. The cardiologist noted that her son was having "8% PVCs" on his EKG; however, again he could not find anything else wrong from a cardiac perspective. By that time, the registered nurse and her son were very frustrated, as they felt there was a physiologic basis for his issues and that this was not all "in her son's head" as the doctors seemed to indicate. Her son said that there was something going on in his head that was bothering him. The registered nurse believed that her son was experiencing some type of unusual, rare complications or issues related to previous episode of chickenpox. The registered nurse told that she did not believe that vaccination with VARIVAX (Merck) directly caused her son problems, but rather, that her son might have some rare "genetic incompatibility" with the varicella zoster virus (VZV), and that for whatever reason, when her son developed chickenpox, her son was somehow more predisposed to develop this unusual complex of signs/symptoms. By early March, her son was having 2 to 5 "episodes" a day of seizure like activity; however, they were becoming shorter in duration and she noticed that her son could sometimes "get thru" the episodes before progression to a full-blown seizure. The registered nurse noted that she would observe her son standing at the counter and could see the beginnings of her son "going out" -i.e. his eyes would begin to flutter and for a moment, her son would seem to be "going out"; however, her son could somehow bring himself back and "re-orient" himself without things progressing. The registered nurse also noticed her son's balance was sometimes off and he would have intermittent episodes of ataxia lasting a few minutes after his seizure-like episodes. Sometime in the first half of March, her son had another "round of chickenpox"; however, this was not diagnosed by a physician. The registered nurse reported that her son developed what appeared to be chickenpox; however, this time, the lesions were all on the same side of his body except for 1 lesion on the other side of his mid-line. During this second outbreak, the registered nurse noticed that her son had a lesion on the left forearm where he had been digging and scratching in previous years. The registered nurse said that the lesion looked very "strange" with "red streaks, which resembled flames" coming from it. The registered nurse said that it looked similar to cellulitis; however, this was not diagnosed. The registered nurse also noted that her son had swollen, hard lymph nodes anterior and posterior to his right ear, which got so large in the back of the ear that they "literally were pushing his right ear forward; however, they were now down to about the size of a 1/2 of a grape behind the left ear. Her son also had a pea-size swollen lymph node behind his left ear. The registered nurse stated that she did a lot of reading and after some research, she decided to began treating her son herself with a regimen of 5000 mg vitamin B-complex twice daily; 1000 mg lysine three times daily; 1000 mg vitamin E daily; 4000 mg vitamin C daily; ZYRTEC (dose unknown) and BENADRYL 25 mg "round the clock" every 4-6 hours. The registered nurse also had him eating 2 oranges, 1 grapefruit - and 1 kiwi daily, as well as doubling-up on raw vegetables and drinking 8-10 glasses of water a day. Additionally, the registered nurse restricted her son's physical activities to make sure her son was not doing anything that elevated his body temperature. The registered nurse reported that after his first day of BENADRYL, her son seemed significantly improved and the frequency of his seizure-like episodes declined. The registered nurse continued to keep him on this regimen of medication/supplements and diet, and said her son had steadily improved. However, the registered nurse made appointments with 2 pediatric specialists for the week of March 20th. Her son would see a pediatric specialist, as well as a pediatric neurologist. The registered nurse noticed that on 16-MAR-2011 her son had 1 new spot as well another one on his chest that was just developing a small pustule. The registered nurse said these were much smaller that the lesions in his previous chickenpox outbreaks and was not sure if either would be any good for specimens. On 25-MAR-2011 follow up information has been received from a registered nurse who reported that his son was on Day 5 of being seizure-free and had improved greatly over the past week. Also she said: "The bottom line is we may never know what caused this". The doctor from the hospital said that he believed her son's presentation was due to the combination of stress, his concussions and fighting a virus. He would not concluded that it was a chicken pox, because were no lesions for him to view and the PCR not through VZVIP on 21-FEB-2011 was negative. Upon internal review, seizures were considered to be an other important medical event. Additional information has been requested.