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Life Threatening? No
Write-up: Information has been received from Sanofi Pasteur MSD (MFR control number PT-1577272925-2016010141) on 12-OCT-2016. Case received from a physician via the Agency on 07-10-2016 under the reference number PT-INFARMED-C201609-58. A female child, 10 y.o., who presented syncope and hematoma in the occipital parietal region, associated with the administration of GARDASIL (batch L032311, 1st dose, administered intramuscularly and DT VAX ADULTO, batch M710045V, intramuscularly. The AE started 5 minutes after the administration of the two suspected drugs, with an approximate duration of 30 seconds. The AE hematoma in the occipital parietal region resulted from the child''s fall as a result of syncope. The child was positioned in Trendelenbourg position and cryotherapy was applied in the clash site. The AE reversed. There are no known previous AE to other drugs. Outcome: Recovery. The child presented syncope after administration of the suspected vaccine (about 5 minutes after vaccination). Sender''s comments: Syncope (fainting) may follow any vaccination, especially in adolescents and young adults. Syncope, sometimes associated with falling, has occurred after vaccination with GARDASIL. Complications (such as haematoma) are not expected. Malaise is also listed for DT VAX ADULTO. Latency (5 min p-v) and duration (30 seconds) are suggestive of the role of both vaccines. Syncope can be triggered by various stimuli including medical procedures. In the current case, 2 vaccines were administered as the same time, but no investigations were performed in order to rule out other aetiology. No treatment used. Spontaneous recovery. No conclusion can be drawn to date. Lot number L032311 (expiry date: not reported) has been verified to be a valid lot number for Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recomb. Vaccine.
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