Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hypoaesthesia, Laboratory test, Nuclear magnetic resonance imaging
Clinical narrative: Information has been received from a consumer concerning her 85 year old husband with a history of myocardial infarction and no allergies who in February 2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck).  In February 2007, 3 weeks after vaccination the patient developed a headache then began to develop numbness and paralysis of the right side of his face.  The patient was diagnosed with Bell's Palsy and then diagnosed with RAMSAY-HUNT Syndrome.  The patient lost the hearing in his right ear.  Multiple unspecified diagnostic laboratory tests were undertaken.  It was reported that various MRI's and CT scans were also undertaken.  Unspecified medical attention was sought.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Upon internal review, lost the hearing in right ear was determined to be an other important medical event.  This was one of several reports received from the same source.  Follow-up information has been received from a physician concerning an 85 year old male with a history of myocardial infarction who on 12-FEB-2007 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) (lot# 656608/0032U).  In approximately March 2007 about 1 month after vaccination, the patient developed shingles in his ear.  The patient also had BELL's PALSY and was droopy on the right and developed RAMSAY HUNT syndrome.  The physician thought the patient was treated with prednisone and acyclovir.  It was also reported that the patient's wife developed BELLS's PALSY (WAES# 0802USA02705).  Subsequently, the patient recovered was noted to be "done fine."  The patient was enrolled in a program to identify if VZV is present and if it is present to identify if it is associated with the wild-type (WT) VZV strain or with the Oka/Merck vaccine VZV strain.  Additional information has been requested.  5/9/08 Received CT & MRI reports only. 5/13/08 Reviewed PCP medical records of 2/12/2007-1/24/208. FINAL PCP DX: BELL's PALSY, right; RAMSAY HUNT syndrome; post viral symptoms. On 2/12/07 pt w/DJD of hands, cough & congestion.  Returned on 3/19/07 w/pain on the right side of his head, scalp & ear for a few days.  Exam revealed slight inflamed right TM & no tenderness/no rash of scalp.  Returned 3/21 w/right eye & facial droop, HA & right ear pain w/decreased hearing.  Tx w/steroids, antiviral meds & eye ointment/patch.  Referred to ENT & seen 4/4/2007.  Exam revealed patient has bilateral hearing loss w/right increased, dizziness, right ear pain.  Patient had herpetic ulcers w/crusting of right inner & outer ear.  Audiology test revealed sensorineural hearing loss, right worse than left. Referred to neuro & seen 5/1/2007.  Continued w/extreme fatigue, hearing loss & intermittent vertigo but BELL's PALSY had resolved.  Tx w/PT for post viral symptoms & vertigo. To this day, my equilibrium is "off" when I walk. I equate this problem at about 20% vetigo. Also, thru examination I have lost about 60% of my hearing in my right ear. Since my encouter with RAMSAY-HUNT I am extremely tired most of the time.