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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Initial report was received by the RA on 27/Sep/2016 from a member of the public (MOP) which concerns her daughter a 12 year old female patient who experienced Malaise, Tonsillitis, Headache, Dizziness, Fatigue, Pain, Nausea, Feeling hot, Epistaxis, Sleep paralysis, Feeling cold, Bruxism, Hypotension, Depressed mood & Stress following vaccination with GARDASIL for Prophylaxis. Concomitant medications: None. Medical history/concurrent conditions: Nil. The patient was a healthy child previously. The patient was vaccinated with three doses of GARDASIL on 11-OCT-2011 (batch no. NP26080), 06-DEC-2011 (batch no. G005669) & 31-AUG-2012 (batch no. G019345). In the patient''s first year of secondary school she started feeling unwell and very sick and was seen by her GP a number of times. The patient''s GP initially thought the patient was suffering from tonsillitis but because she was ill so often the GP referred the patient onto a specialist. The patient had her tonsils removed in 2014 and had a bad reaction to the anaesthetic. The surgeon couldn''t understand how the was so ill afterwards and queried had she been sick before admittance. The patient had a longer than expected recovery and was still feeling unwell. Her throat is still sore but not as bad. She has chronic and severe headaches. She feels like she is going to faint. She has chronic fatigue. She has pains in her arms, legs, feet, hands & neck. She feels nauseous from the headaches. She had all these symptoms before surgery except for the pain in her limbs (which she also describes as feeling hot). More recently the patient has been getting frequent nose bleeds and what sounds like sleep paralysis. She complains of being hot and cold. The patient''s eyes were tested and she got glasses to try to alleviate the headaches. The patient also got a mouth guard to stop her grinding her teeth. The patient also tried painkillers and migraine medication but none of these helped. The patient used to be physically active - horse riding daily and helping out at stables but is now abnormally tired. The patient underwent a CT scan which appeared normal and all blood tests were fine too. The reporter indicated that the patient''s BP has been a little low. The patient was also reviewed in an eye clinic where they could see signs of past infection behind her eyes - normally indicative of juvenile arthritis but tests were negative and she is waiting to see a consultant. The patient often cries because her head is so sore and because of her pains. The patient has missed a lot of school and is getting very down in herself as a result is stressing regarding upcoming exams. At the time of reporting the patient''s symptoms were persisting active of juvenile arthritis. Tests for this proved negative but she is waiting to see the consultant. The eye clinic has since said that they now don''t think what they saw is relevant, that it is normal. She often cries because her head is so sore and because of her pains. I feel so bad because we put all of her feeling unwell for years down to tonsils. Now we believe it is from the HPV vaccination and we did not make the connection as put everything down to being Ill with tonsils - but with hindsight we believe that this may have masked other symptoms to us. Looking back though it seems very coincidental she did not have health issues before she went to secondary school and with hindsight got the vaccination. She is missing so much school and has done all the way through second level. She had good attendance previously. I am concerned that she is getting very down about how she is feeling and she is stressing as is in her leaving cert year. She is equally unwell during school holidays; even on a holiday to France recently she spent Considerable time in bed and seems to have no let up from her debilitating symptoms. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported events are considered unlikely related to GARDASIL. The evidence is not sufficient to suggest a relationship between the GARDASIL and the reported serious adverse events of Malaise, Tonsillitis, Headache, Dizziness, Fatigue, Pain, Nausea, Feeling hot, Epistaxis, Sleep paralysis, Feeling cold, Bruxism, Hypotension, Depressed mood & Stress. Causality assessment is impacted by the confounding factor of the time frame between the last dose of vaccine and the onset of all events. Company Comment- No changes to the GARDASIL safety information are warranted at this time. Merck and Co., Inc., known as MSD outside of the country, continues to monitor the safety profile of the GARDASIL.
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