Age: 22.0
Sex: F
Vaccine: HEPA
Symptoms: Disorientation, Grand mal convulsion, Immediate post-injection reaction, Loss of consciousness, Somnolence
Clinical narrative: This case was reported by a pharmacist and described the occurrence of grand mal seizure in a 22-year-old female subject who was vaccinated with HAVRIX 1440 (GlaxoSmithKline). Concurrent medical conditions included fainting episodes and possible seizure disorder. Per the pharmacist, the subject had "a possible seizure disorder and it is undiagnosed" as the subject "said she had fainting episodes and did not indicate she had seizures." On 18 June 2013 at 19:00 the subject received 1st dose of HAVRIX 1440 (1 ml, unknown route, left arm). On 18 June 2013, immediately after vaccination with HAVRIX, the subject experienced grand mal seizure. The subject was sent to the emergency room. It was unknown if the subject "was kept overnight" at the hospital. The pharmacist indicated that the HAVRIX immunization series had been discontinued. The pharmacy provided the HAVRIX vaccine free "due to an outbreak of some berries that were associated with Hepatitis A." The pharmacist considered the event was clinically significant (or requiring intervention). On 18 June 2013, at 19:01, 1 minute after onset, the event was resolved. The pharmacist considered the event was possibly related to vaccination with HAVRIX. Follow up was received from the pharmacist on 8 July 2013. The pharmacist indicated that the subject received HAVRIX 1440. The pharmacist documented that the event of grand mal seizure was witnessed. The pharmacist did not know if the event was preceded by an aura. The pharmacist documented that the subject's symptoms were generalized. The subject did lose consciousness and was disoriented or drowsy upon regaining consciousness. Per the pharmacist, the subject did remember the event and did not experience urine or fecal incontinence. The pharmacist reported that there was evidence that the symptoms may have resulted from withdrawal of alcohol or other psychotropic substances. The pharmacist reported that use of alcohol or tobacco was not applicable. The pharmacist reported that she "inquired about recreational drug use and the [subject] denied using anything." Per the pharmacist, there was no planned follow up of the event and it was unknown if the subject was given driving restrictions. It was unknown to the pharmacist if there were any diagnostic tests. The pharmacist considered the event to be serious due to jeopardizing the patient or requiring intervention and not serious due to involved or prolonged hospitalization or congenital anomaly or birth defect. The pharmacist documented that the following medical history, concurrent illness could have been associated with the event; the pharmacist reported that the subject stated "she was nervous about getting the vaccine." Later, the subject "stated she has had 'fainting' spells." The subject did not have a history of seizures (including febrile seizures and epilepsy), movement disorders, head injury, or other central nervous conditions such as CVA, transient ischemic attacks, psychiatric disorders, etc. The pharmacist documented that it was unknown if the subject had received HAVRIX before. The pharmacist also documented that it was unknown if the HAVRIX vaccination series was discontinued or delayed; previously she reported that the series had been discontinued. It was unknown if symptoms recurred following subsequent administration. It was unknown if there were adverse events following previous vaccinations. The pharmacist stated that the vaccine was provided by the pharmacy "because of possible hepatitis A exposure from tainted frozen berries."