Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Initial report received on 14 November 2012 from an investigator participating in a study. A 49-year-old female subject had severe headache on 02 November 2012 after receiving first dose of the study vaccine QIV-ID. This vaccine is thimerosal-free) or control product TIV-ID1. This vaccine is thimerosal-free) or control product TIV-ID2. This vaccine is thimerosal-free) on 02 November 2012 (Route and site of administration and batch number not reported). The subject had no reported medical history. The subject had no reported concomitant therapies. The subject experienced the associated symptom of severe headache on 02 November 2012. The subject went into the hospital with complaint of severe headache as a reaction to TOPAMAX. Hence she was hospitalized on 03 November 2012. The subject stayed two days in the hospital. Hospital discharge reports were awaited at the time of this report. Laboratory investigations and corrective treatments were not reported. Outcome of the event of severe headache was not reported. According to the investigator, the event was related to the study vaccine and it was not related to the trial procedures. It was not reported whether the event led to the termination of the subject from the study or not. List of documents held by sender: None. Medical Assessment: This case of "severe headache" experienced by a 49 year old female subject on the same day of vaccination was assessed as related by investigator based on temporal relationship. The event of headache within seven days of vaccination is also captured as solicited systemic event in this study. The subject went into the hospital with complaint of severe headache as a reaction to TOPAMAX. It is not clear if TOPAMAX was given because of partial seizure (its indicated use) or for cluster headache (investigational use), when it was given in relation to the vaccine (before or after) and the reason for giving it and by whom, since there is no reported medical history of seizure or prior therapies. Further details on the pre-existing medical history, especially of the medication of TOPAMAX as well as diagnostic test results (if any) during hospitalization may be informative in the assessment of alternative etiologies. The sponsor assesses this event as related to study vaccine based on temporal relationship. Cumulative Assessment: This is the fourth case of severe headache as the main manifestation reported from any clinical study of FLUZONE vaccines (FLUZONE IM, HD, ID and QIV) conducted by the sponsor. The other three cases of severe headache as the main manifestation occurred more than 7 days post vaccination and were considered as unrelated by investigators. There were 34 cases of severe headache event reported as co-manifestation of other diseases in the clinical studies of FLUZONE vaccines (FLUZONE IM, HD, ID and QIV) conducted by the sponsor and all events were considered as unrelated to study vaccine by investigators. There were 75 cases of severe headache received from spontaneous sources after administration of standard FLUZONE or FLUZONE High Dose or FLUZONE Intradermal seasonal vaccine during the period of around 2 decades i.e. from 1993 to 2012.