Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Vomiting
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of headache in a 41-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Past medical history included migraines. Concurrent medical conditions included hepatitis C. Concurrent medications included PREMARIN. On 7 December 2011 at 14:40 the subject received 1st dose of HAVRIX (1 ml, unknown route, left arm). On 7 December 2011, 20 minutes after vaccination with HAVRIX adult, the subject experienced headache. She thought she was having an allergic reaction and self administered ADRENALINE. The headache worsened and "after 15:00" the same day she began to vomit. She went to an emergency room and was treated with BENADRYL, ZOFRAN and liquid diet (clear liquid diet). She was not admitted to the hospital. At the time of reporting the vomiting resolved, the headache was improved and the outcome of possible allergic reaction was unspecified. The healthcare reporter assessed the event of headache as probably related to vaccination with HAVRIX and did not provide causality assessment for the events. Follow-up information was received on 4 January 2012 from the healthcare professional. The subject's medical history included bilateral saphingo-oophorectomy, renal stent placement and total abdominal hysterectomy. Concurrent medical conditions also included abstains from alcohol, previous anaphylactic reaction to an unknown allergen, anxiety disorder, cigarette smoker, cyst of kidney-acquired, hepatitis C, multiple drug allergies, post-traumatic stress disorder, pseudoseizures and recurrent kidney stone. Concurrent medications additionally included FLEXERIL, ZOLOFT, LAMICTAL, EXCEDRIN migraine and TOPAMAX. Upon follow-up the event possible allergic reaction was updated to anaphylaxis as the healthcare professional indicated that the subject had experienced anaphylaxis with hepatitis A vaccine. It was reported that the subject was prescribed ZOFRAN for nausea in the emergency room. The healthcare professional reported that the subject stated that "the injection" (not specified) also triggered a migraine headache. The vaccination course with HAVRIX was discontinued. The healthcare professional considered the event of headache as clinically significant (or requiring intervention). The events of headache, shaking, anaphylaxis and vomiting resolved on 8 December 2011. At the time of reporting the outcome of the additional events of nausea and migraine headache were unspecified. The healthcare professional considered the events of headache, shaking and anaphylaxis as probably related to vaccination with HAVRIX. The healthcare professional did not identify HAVRIX as a suspect product with vomiting. The healthcare professional considered the events of headache and shaking as probably related to Epi-pen and vomiting as possibly related to Epi-pen. Causality assessments for nausea and migraine headache were not reported. The healthcare professional reported that the event (s) may have also been associated with the subject's medical history of migraine headache, post-traumatic stress disorder and pseudoseizures.