Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Alopecia areata
Clinical narrative: Initial and follow up information has been received from a consumer via an agency as part of a business agreement (Sender's case report number SE-1577272925-E2007-05342) on 20-DEC-2013. Initial case was reported on 09-aug-2007 by a consumer (mother of patient). It was reported that a 13-year-old woman was vaccinated with GARDASIL (batch number unknown, route not reported and administered in the arm) on 15-jun-2007. In the end of July 2007 it was noted that the girl had severe hair loss, and on 08-aug-2007 it was discovered that she had 3 bald patches. At the time of reporting (09-aug-2007) the outcome was not recovered. Case is closed. Follow up information received on 16-Oct-2013 and 17-Oct-2013 from health care professionals (General practitioner) and from health Authority in a foreign country under the reference number 133817. The case is now medically confirmed. It was reported by the mother that the hair loss started in August/September 2007, not July as previously reported. However, the HA reported has July 2007 as onset of AE. She has been diagnosed with alopecia areata and she is more or less totally bald, but hair growth comes back some times. The batch number of the first dose (administered on 15-Jun-2007) was NE47370, lot. 655376/0572F, exp. 05-MAY-2009. The second dose was given on 20-Aug-2007 and the third dose 27-Nov-2007 (batch number NF13730, lot 1341F, exp. 19-NOV-2009 and NF27900, lot no. 1537F, exp. 15-NOV-2009 respectively) (the date of third dose was contradictory reported as 28-Nov-2007 by mother of patient). It was reported that no one in the family of the patient has a history of alopecia. At the time of reporting the outcome was not recovered. Follow up information received from the HA on 16-Dec-2013. Complementary information received by the HA on 10-Dec-2013. The event is now reported from consumer. The patient's weight (60 kg) and height (168 cm) is now updated. Alopecia Areata with onset date 10-AUg-2007 (contradictory information regarding onset date from health care service, who reports "end of Jun-2007" in one place in the report and "Jul-2007" in another place as well as from consumer). The problems start after second dose (discrepancy: dose 1 is coded as suspected dose by the HA), so onset is changed to 10-Aug-2007 according to consumer. The adverse reaction is not recovered. The patient has been treated with non-prescription ointments as well as tablets for alopecia/thin hair (no further information provided). The HA has according to applicable guideline for assessment of seriousness, classified the adverse reaction as serious. The relatedness assessment is changed from "unclassifiable" to "possible". Batch number is missing. HA also updated route of administration for D1 GARDASIL to intramuscular. Noteworthy: The patient received D1 and D2 GARDASIL (batch numbers NE47370 and NF13730) on 15-Jun-2007 and 20-Aug-2007 respectively. This information was received the company on 07-oct-2013 from the patient's mother. The company judged relevant to keep dose 2 as suspected dose due to the discrepancies reported. HA has performed a follow up with the consumer to clarify the discrepancies of the onset date and doses.