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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: Information has been received from Health Authorities on 19-MAY-2011 under the reference number PO20110312 case medically confirmed. A 16 year old female patient had a dose of GARDASIL (Batch number not reported) via subcutaneous route - instead of intramuscular as recommended - on 01-MAR-2011. On 10-MAR-2011 the patient presented with angina which was treated with cefuroxime and RHINOFLUIMUCIL. Both medications were stopped on 15-MAR-2011. On 15-MAR-2011, i.e. 14 days after vaccination, the patient experienced malaise with asthenia, nauseas, sweatings and decrease of muscular strength, as well as uncontrolled loss of urine. On the same day she also presented with hypoallesthesia of the four limbs. Guillain Barre Syndrome was suspected. Urinary toxic search were negative. Viral serologies were negative too. On 23-MAR-2011, mild polyradiculoneuritis was diagnosed. At the time of reporting, the outcome was unknown. The Health Authorities assessed the causal relationship between the reported reactions and vaccination as doubtful (C1 S1 I1) according to the method of assessment. The same assessment was done between the reported reaction and the medication with cefuroxime and RHINOFLUIMUCIL. Upon medical review, the company judged relevant to code wrong route of administration and pharyngitis, which mentioned by the CA in the narrative but not coded. Polyradiculoneuritis, pharyngitis and vaccine administered via SC instead of IM route were considered to be disabling. Other business partner numbers include E2011-03095.
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