Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza, Injection site erythema, Injection site haematoma, Injection site inflammation, Malaise
Clinical narrative: This is in follow-up to report(s) previously submitted on 9/24/2008; 12/23/2008. Information has been received from a 65 year old female with depression, high blood pressure, chronic fatigue immune dysfunction syndrome, fibromyalgia and sensitivity to a lot of drugs. The patient also had a history of herpes outbreaks (not genital) and stomach upset which was caused by CELEBREX (manufacturer unspecified) who on 25-JUL-2008 was vaccinated subcutaneously in her left upper arm with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included hydrocodone, amitriptyline hydrochloride, UNIVASC, XANAX. On approximately 27-JUL-2008 (2 - 3 days after vaccination) the patient experienced a hot, red, encircled hematoma, arm soreness, diarrhea, flu symptoms, tiredness and feeling sick. The patient experienced a hematoma at the injection site, and the injection site was red and inflamed. She also had a tiny rash but it was went away. The patient had severe pain in the arm where she received the injection. The patient was feeling better after the pharmacist advised her to elevate her arm to reduce soreness. The patient said the flu-like symptoms felt like she felt during her non-genital herpes outbreaks or they might be chronic fatigue immune dysfunction syndrome. The hematoma was getting smaller and better. The patient's symptoms were resolving. The patient sought medical attention by taking to the pharmacist. Follow-up information was received from the patient who reported that she had constant pain in the arm that she received the ZOSTAVAX (Oka/Merk) injection. It got really bad at times but it was a constant ache. The patient continued to have severe aching radiating from her left shoulder down her left arm. She also had a hematoma at the injection site. The hematoma at the injection site was still present but it was greatly reduced in size. Initially, it was the sized of a baseball but now it was the size of a nickel. She was of the opinion that she had polymyalgia rheumatica.  The patient had a weakened immune system at the time of vaccination and she indicated that her physician did not warn her not to get the vaccine. No further information is available. On 12-SEP-2008, the patient reported that she still had the pain after receiving ZOSTAVAX (Merck). She had compromised immune system called "chronic fatigue dysfunction" prior to getting ZOSTAVAX (Merck) and "she had this for years". Follow-up information was received from the pharmacist and the patient who reported that the patient was still experiencing pain. The patient had the very sore arm. Follow-up information received on 03-DEC-2008 from the consumer, indicated that she still had horrible stabbing an shooting pain that "comes and goes and gets worse when the weather changes". The consumer believed that she broke out in a rash at the injection site, and now has PHN. The consumer reported that she woke to her Rheumatologist and she believed that she got a small case of shingles from the vaccination and she had PHN. This is a consolidation of two reports concerning the same patient. No further information is available.