Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension, Laryngitis, Nervous system disorder, Pruritus, Rash
Clinical narrative: Initial and follow-up information has been received from a 76 year old female with hypertension and "thyroid bisectame" and allergies to peanuts and cat dander who on 21-MAR-2008 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included unspecified beta blockers and thyroid medication. On 21-MAR-2008, 20 minutes after vaccination, the patient broke out in hives on her chest, back, and forehead. They were itchy for about three days and she still had little red marks but they did not itch any longer. The patient spoke to her physician and was told to take diphenhydramine hydrochloride (BENADRYL). No diagnostic laboratory tests were performed. The patient reported her original symptoms lasted for about 12 days and went away. On the morning of 11-APR-2008, she felt it coming back and now has hives on her chest, back, and forehead. Her blood pressure has increased to 160/103. After she got the vaccination, she felt weak and shaky. She still feels this way but not as bad. She feels a little bit dizzy. She believes that it may be affecting her nervous system and that "the virus may not have been attenuated enough." A product quality complaint was not involved. Information has been received from a physician concerning this 76 year old female consumer with no known allergies and hypertension who on 21-MAR-2008 was vaccinated with a first dose of 0.65ml of zoster vaccine live (Oka/Merck) (lot # 659323/1613U). Concomitant therapy included hydrochlorothiazide, lisinopril, metoprolol, "thyroid extract" and aspirin. Subsequently, on 27-MAR-2008 the patient developed a rash on her chest and arms after receiving the vaccination. The rash was described as flat, red and splotchy. Medical attention was sought. The patient was seen by the physician and a "CBC" was performed (results not reported). At the time of the report the patient had not recovered. There was no product quality complaint involved. On 12-MAY-2008, additional information was received from another physician concerning the patient who on 21-MAR-2008 was vaccinated with zoster vaccine live (Oka/Merck). There was no concomitant medication (previously reported as being on concomitant therapies). On 21-MAR-2008 (previously reported as 27-MAR-2008), within a few hours of receiving zoster vaccine live (Oka/Merck), the patient developed widespread urticaria. The patient was initially treated with Benadryl by an unspecified allergist. The symptoms did not improve. On 12-MAY-2008, the patient was seen by the reporting physician and the exam revealed persistent widespread urticaria. The physician prescribed Zyrtec and referred the patient for an allergy consult. The patient's widespread urticaria persisted. Follow-up information has been received from the patient's husband. The husband reported his wife "broke out" again on 11-MAY-2008 and developed laryngitis. It was noted that this was about the fifth time that his wife has broken out. At the time of the report the patient's status was unknown. Follow-up information from the patient indicated that she had an outbreak today (16-MAY-2008) at 4:00 am. The patient also reported that she spoke to her allergist. Additional information has been requested.