Your Health. Your Family. Your Choice.
Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: Information has been received from SPMSD (Sender''s report number GB-1577272925-E2014-02531) on 02-MAY-2014. This non serious case was received on 14-Mar-2014. This case is not medically confirmed as it was reported by a consumer (patient''s mother). A female patient had received a dose of GARDASIL (batch number not reported) dose, route and site of administration not reported and on unreported date after vaccination, she felt very unwell with a lot of pain. It started as pain in her leg, then her back and body and she is now riddled with pain. The patient had received two doses, one of Sep-2012 and one in Oct-2012 of CERVARIX (batch number not reported) dose in series, route and site of administration not reported, no information about onset of adverse event or not. At the time of reporting, the outcome was not reported. Follow-up information received on 28-Apr-2014 from the general practitioner with medical records from paediatricians. The case is now medically confirmed. The patient was 14 year old at the time of events and was 68 kg and 162.4 cm. She received a first dose of CERVARIX intramuscularly on 21-Sep-2012 and a second dose of CERVARIX intramuscularly on 19-Oct-2012. She had a medical history of behavioral problems and hypotonia on 01-Jan-2002. On 08-Mar-2013 the patient experienced back pain, flitting body pain and fatigue, all severe. According to the general practitioner, the relationship to the vaccine was assessed as unknown. She was fully investigated by paediatricians and neurology leading to diagnosis of a functional disorder. She received the first dose of GARDASIL intramuscularly on 22-May-2013. On 06-Feb-2014 the patient experienced migraine. On 25-Mar-2014 the patient experienced fatigue and body pains. The report of paediatrician was provided: The patient consulted paediatrician for pain and aches started in her back and neck and then in both her limbs, hips, shoulders and legs. She also reported persistent paresthesia particularly in her hands with subjective loss of grip in her hands. Her symptoms have been variable and intermittent but persistent, to the extent that she has had little school attendance for a few months now, due to the complaints of pains. The patient''s clinical examination of her neurological system and musculoskeletal system had repeatedly been uninformative, apart from the persistent finding of absence of her deep tendon reflexes in both her upper and lower limbs. The patient complained of occasional pains behind her sternum, given her feelings of breathlessness. She also complained of her hands going white and itchy. The patient''s sleep pattern reversed as she slept for most of the day and only wakes up around three or four o''clock in the afternoon, despite her parents efforts to wake her up in the morning. She said she went to bed around four or five o''clock in the morning and she felt very tired. The patient recently complained of headaches which she described as thrumping with no preceding aura. Headaches usually involved all of her head, mainly of the left side of her head, including her face. The patient''s mother noticed on several occasions, swelling eye of the patient but no complaints of the eye being watery. The patient experienced drooping of left side of her face which according to the patient''s mother gave the impression of facial palsy. There were no complaints of early morning headaches and vomiting. Headaches were worse with light and did not get worse with coughing or straining. The patient was treated with pizotifen 0.5 mg tablets, 2 tablets once a day. The patient had not managed to go to school since being in the hospital and at the time of reporting hasn''t been back to school for months. The patient said that is was because she felt very sore in the morning. Recently, the patient become panicky around social situations, she almost went into a panic attack, hyperventilating. The patient''s mood were terrible and she has gained weight. She did not report any suicidal ideations. The patient was treated with amitriptyline 20 mg at night, prescribed by the general practitioner and had been of some help for her pains. The patient reported she lacked any motivation. She dragged her legs when walking and her reflexes were still absent. All adverse events reported appeared after the GARDASIL injection. Investigations: First MRI of spine reported mild oedema of anterior column. Lumbar puncture performed was negative for cells, protein and CSF sugar were normal, CSF/serum IgG/albumin ratio was 0.6. The sample was insufficient to do oligoclonal bands. Nerve conduction study was normal. Lyme''s serology, full blood count, plasma viscosity, CRP, thyroid function and liver function were normal. The second MRI of spine and head was normal and there was no sign of any oedema which has been seen on the previous scan, no signs of intracranial abnormality. Neurologist report was provided: The patient listed her symptoms in order of importance as following: variable leg pain, chest pain, headaches, no strength in her hands and overall weakness. She has been off school since Oct-2013. The patient described the pain in her legs predominantly on the left with paraesthesia of the patella and pain spreading down her lower leg. Her hands and feet were intermittently numb. Headaches occurred 4 or 5 times a week and were unilateral and associated with nausea, lasted several hours and abolished after she had a sleep. Pizotifen seemed to have reduced the frequency of these somewhat. The patient was able to stand on her right leg reasonably well. She could just about jump and was able to do heel to toe walking. On the examination couch, she had good power except perhaps in her shoulders where there was an odd rhythmic twitching to some of her muscle groups that the neurologist did not feel had an organic basis. Her tone was normal. Cranial nerves were normal. The paediatrician and neurologist have diagnosed functional disorder. According to the reporter the relationship of back pain, body pain and fatigue to the vaccine was unknown. The paediatrician and neurologist did not feel the adverse events were related to vaccine. The reporter considered that case serious due to the patient''s disability. At the time of reporting, the patient had not recovered from all the adverse events.
Copyright © 2018 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166