Age: 48.0
Sex: F
Vaccine: FLU3, HEP, FLU3, HEP
Symptoms: Bone pain, Pain in extremity, Product quality issue, Similar reaction on previous exposure to drug
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of aching-both legs in a 48-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent vaccination included seasonal influenza vaccine (non-gsk) (Flu shot; Sanofi Pasteur MSD; unknown) given on 3 November 2009. On an unspecified date, the subject received 1st dose of ENGERIX B (unknown). On 3 November 2009 at 09:30 the subject received 2nd dose. On an unspecified date, at an unspecified time after vaccination 1st dose with ENGERIX B (first dose), the subject experienced "similar events" (unspecified event). On 4 November 2009 in the morning, 1 day after vaccination with ENGERIX B (second dose), the subject experienced aching legs. On 5 November 2009 in the morning, 2 days after vaccination with ENGERIX B (second dose), the subject experienced bilateral foot pain. In November 2009, at unspecified time after vaccination with ENGERIX B (second dose), the subject experienced bone pain especially in legs. The healthcare provider reported the vaccination was administered at a laboratory. The subject reported aching legs on 04 November 2009 in the morning, and took TYLENOL but it did not help. On 05 November 2009, the subject had foot pain (both feet). At the time of reporting, the subject's "legs hurt all the way to the bones" (bone pain especially in legs), and her feet hurt. The healthcare professional reported the subject had "similar events" following the first administration (first dose in series) of the vaccine. Although at the time of her second vaccination (03 November 2009 at 09:30), the subject denied any reactions with her first injection of ENGERIX B series. At the time of reporting, the healthcare professional had decided to suspend use of the remaining doses from the lot until further consult. The healthcare professional indicated no Quality Assurance issues with the product at the time of this reporting. The subject was treated with TYLENOL. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention0. At the time of reporting, the subject's aching in both legs were worse, bilateral foot pain was unresolved, and bone pain especially in legs and unspecified event were unknown. The healthcare professional considered the aching legs, bilateral foot pain and bone pain especially in leg were possibly related to vaccination with ENGERIX B. It was unknown the relatedness of unspecified event. This is one of four cases reported by the healthcare provider; see cases A08155433, A0815870A and A0815879A for subjects who experienced adverse events following vaccination with ENGERIX B. GSK case number A0815886A is a duplicate of A18515453A. All future correspondence will be submitted to A1815453A. Follow up was received on 06 November 2009 via the reporting healthcare professional. The healthcare professional wanted to file a Quality Assurance (QA) report. The healthcare professional reported that she received 20 ENGERIX B vials in October 2009. She had distributed six vials and four subjects developed severe reactions to the vaccinations. The healthcare professional felt that the vaccines have a quality issue (pharmaceutical product complaint), and she would not use the rest of the vials from lot/shipment. She would like to return the vials to evaluate and investigate for quality issue.