Sex: F
Vaccine: HIBV
Symptoms: Drug administered to patient of inappropriate age, Immediate post-injection reaction, Injection site discolouration, Vaccine positive rechallenge
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 13-day-old female patient who received HIBERIX (batch number 4B745, expiry date 23rd February 2018). Co-suspect products included HIBERIX (batch number 2S27K, expiry date 17th September 2017), HIBERIX (batch number 4294M, expiry date 20th January 2018), HIBERIX (batch number 5FC3Z, expiry date 20th January 2018) and MENVEO. On 20th January 2017, the patient received the 1st dose of HIBERIX. On 9th March 2017, the patient received the 2nd dose of HIBERIX. On 12th May 2017, the patient received the 3rd dose of HIBERIX. On an unknown date, the patient received HIBERIX and MENVEO at an unknown dose. On 20th January 2017, immediately after receiving HIBERIX and not applicable after receiving HIBERIX, HIBERIX, HIBERIX and MENVEO, the patient experienced injection site hyperpigmentation and inappropriate age at vaccine administration. On 9th March 2017, the patient experienced injection site hyperpigmentation. On 12th May 2017, the patient experienced injection site hyperpigmentation. On an unknown date, the patient experienced injection site hyperpigmentation, injection site hyperpigmentation and inappropriate age at vaccine administration. Rechallenge with HIBERIX was positive. Rechallenge with HIBERIX was positive. Rechallenge with HIBERIX was positive. On an unknown date, the outcome of the injection site hyperpigmentation, injection site hyperpigmentation and injection site hyperpigmentation were recovered/resolved and the outcome of the injection site hyperpigmentation and injection site hyperpigmentation were not recovered/not resolved and the outcome of the inappropriate age at vaccine administration and inappropriate age at vaccine administration were unknown. The reporter considered the injection site hyperpigmentation to be almost certainly related to HIBERIX. The reporter considered the injection site hyperpigmentation to be almost certainly related to HIBERIX. The reporter considered the injection site hyperpigmentation to be almost certainly related to HIBERIX. The reporter considered the injection site hyperpigmentation to be almost certainly related to HIBERIX.  The reporter considered the injection site hyperpigmentation to be almost certainly related to MENVEO. Additional details were reported as follows: The age at vaccination was not reported. After the administration of HIBERIX a black dot was left on the patient, may be MENVEO as well. The black dot had not gone away from the patients after months of administration. The health care professional said that it may be up to six patients and 4 different lots. Only two patients' information was given. When probing a little more the health care professional felt it could be MENVEO as well. The spots appear immediately, at the time of vaccination, after vaccination. On 20th January 2017, the patient received the 1st dose of HIBERIX, at age of 13 days, which lead to inappropriate age at vaccine administration. On an unknown date the patient received booster dose of HIBERIX, which lead to inappropriate age at vaccine administration. This is 1 of the 2 reports reported by same reporter. The batch number reported for HIBERIX (2527K) did not exist and was updated to 2S27K as per sales database.