Age: 56.0
Sex: M
Vaccine: HEP, IPV, MEN, TYP, YF
Symptoms: Herpes simplex serology negative, Immunology test, Lumbar puncture abnormal, Mental impairment, Myalgia
Clinical narrative: Initial case was received from the CDC on 08 July 2010. A 56-year-old male patient received on approximately 08 June 2010 injections of YF VAX (lot number not reported), Hepatitis B (manufacturer and lot number not reported), Polio (manufacturer and lot number not reported), and Typhoid (manufacturer and lot number not reported). On approximately 15 June 2010, seven days post vaccination the patient developed a progressive headache and altered mentation. The patient was seen in the emergency room (ER) on 04 July 2010 and a computed tomography (CT) scan was performed and was reported as normal. The following laboratory findings from 04 July 2010 were as follows: Cerebral spinal fluid (CSF): white blood cell (WBC) 13, neutrophils around 50%, protein 65, glucose normal, negative for enteroviruses, HSV and WN Ab as well as Cryptococcal Ag. The patient was admitted to the hospital with a diagnosis of encephalitis/ADEM. On 07 July 2010, his laboratory findings were as follows: CSF: WBC into 80's and protein 93. Awaiting same shipment to CDC for testing. The patient was receiving glucocorticosteroid (triamcinolone) injections (indication reported as not sure). The outcome was not reported. A request was made from a foreign Medicines Agency on 03 August 2010 to amend the laboratory data per requirements. As a result, a new version of the case was created on 05 August 2010 for laboratory data amendment; and company assessment was revised. on 06 August 2010, this case 2010-03810 has been identified as a duplicate of case 2010-03984 (case to be deleted). All information previously contained in 2010-03984 as been added to 2010-03810, and 2010-03984 will now be deleted from the data base. This case was received from Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) via VAERS line list report (VAERS ID number 392444-1). Follow-up information was received from a health care professional on 05 August 2010 confirmed the VAERS ID number as 392444-1. The patient was admitted to the hospital with a diagnosis of encephalitis/ADEM. The patient's medical history and any previous illness were unknown (previously reported as not reported). The patient received the following vaccines on 07 June 2010: a subcutaneous (sc) left arm injection of YF VAX (lot number UF716AA), an IM right arm injection of IPOL (lot number D0548) and an IM right arm injection of TYPHIM VI (lot number D0412). The patient received an intramuscular (IM) right arm injection of MENOMUNE A/C/Y/W-135 (lot number UF542AA) which was reported in case 2010-03984 but not reported previously in case 2010-03810. The patient had an IM left arm injection of Hepatitis B vaccine in case 2010-03810 which was reported in case 2010-03984 as a unspecified Hepatitis vaccine (GSK lot number AHBVB832AA). The patient was receiving concomitant KENALOG injections (indication reported as not sure). On 09 June 2010, two to three days after vaccination, the patient complained of low grade fever, arthritis, and myalgia. The patient improved. Then around 16 June 2010, the patient developed a headache (HA) on the left side which became so severe that he was seen in the emergency room (ER) on 04 July 2010. The following laboratory findings from 04 July 2010 were as follows: Cerebral spinal fluid (CSF): white blood cell (WBC) 13, neutrophils around 50%, protein 65, glucose normal, negative for enteroviruses, HSV and WN Ab as well as Cryptococcal Ag. The patient was released from the ER. On 07 July 2010, his laboratory findings were as follows: CSF: WBC into 80's and protein 93. On 07 July 2010, the patient became sluggish in mentation and was admitted to the hospital. A magnetic resonance imaging (MRI) was supportive of mild encephalitis. The patient also had a lumbar puncture (LP) and a Herpes and West Nile test performed (Results were not provided). Information received from the CDC on 05 August 2010 reported "The serum and both CSF samples (day 27 post-vaccination and day 30 post-vaccination) were positive by ELISA for IgM against yellow fever. The neutralizing antibody titers were raised in the day 27 serum (2560) as is to be expected after vaccination and low (<2; and 4 respectively) in CSF. Our laboratory did not run PCR testing because of the longer interval between initial onset of symptoms and sample collection, however, the extremely low titers of neutralizing antibodies in the CSF would argue against a direct YF viral encephalitis and rather (if indeed related to the vaccine) implicate Acute Disseminated Encephalomyelitis (ADEM)." Follow-up information received from the CDC on 19 November 2010 reported that the patient had no pre-existing conditions and no current illnesses. The patient also had the symptom of bradyphrenia. The patient was hospitalized for 5 days (date of discharge not provided). The outcome remained not reported. Documents held by sender: None.