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Life Threatening? No
Write-up: This case was reported by a foreign regulatory authority (# DE-PEI-PEI2009020984) and described the occurrence of nephritis in a 5-month-old female subject (born 02 April 1991) who was vaccinated with TWINRIX pediatric (GlaxoSmithKline). Previous vaccination with Diphtheria + tetanus + pertussis + polio + haemophilus influenzae vaccine given on 03 July 1991 and 31 July 1991 was well tolerated. On 4 September 1991 the subject received 3rd dose of combined Diphtheria + tetanus + pertussis + polio + haemophilus influenzae vaccine (unknown manufacturer, unknown route, probably right thigh). At an unspecified time after vaccination with Diphtheria + tetanus + pertussis + polio + haemophilus influenzae the subject experienced fever and bulging fontanelle. Meningism was suspected but not confirmed. Next vaccinations with TWINRIX pediatric given on 06 May 2002 and 17 June 2002 were well tolerated. On 6 January 2004 the subject received 3rd dose of TWINRIX pediatric (unknown route, unknown upper arm). At an unspecified time after vaccination with TWINRIX adult, the subject experienced recurrent nephritis, infection, headache, ear pain, toothache, unclear fatigue and nausea. Ambulatory treatment was necessary. The subject was hospitalised. At the time of reporting the events were resolved. After the next vaccination with Diphtheria + tetanus + pertussis + polio + haemophilus influenzae vaccine these events did not recur. On 30 April 2007, 26 June 2007 and 16 November 2007 the subject received GARDASIL (Sanofi Pasteur MSD, intramuscular, left upper arm). An unspecified time after vaccination the subject experienced felling of illness, headache, nausea and recurrent dyspnoea. No further information has been provided. No further information will be available.
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