Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Insomnia, Neuralgia, Pain, Pain in extremity
Clinical narrative: Information has been received from a 62 year old male consumer referring to himself. Drug reactions/ allergies included allergic to sulfanilamide (reported as "sulfa"), codeine and gabapentin. On 01-SEP-2015, the patient was vaccinated with ZOSTAVAX (dose, route and lot number not provided) for prevention of shingles. On 21-SEP-2015, he experienced a rash and it was very painful and sore. The patient could not sleep and was in a lot of pain. He underwent a x-ray for cholesterol (result unknown). The patient went to the emergency room and was given pain medication "fanciclovir" 500 mg for 10 days. The outcome of the events was reported as not recovered/not resolved. Information has been received from a male patient of unknown age referring to himself. Information about medical history and concurrent conditions were unspecified. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot number, dose and route were unknown) for prevention of shingles. Concomitant medications were unspecified. On an unknown date, the patient developed contracted shingles. The patient was reluctant to provide any additional information on his condition. The outcome of the event was unknown. The causality between the event and ZOSTAVAX was not provided. No PQC involved.  Follow up information has been received from a healthcare professional on 07-OCT-2015. The patient had DILAUDID allergy. In approximately 1961 when the patient was 8 years old, he had chickenpox. The patient had no prior history of herpes zoster or herpes zoster ophthalmicus. On 01-SEP-2015, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, lot number K020187) subcutaneously in left arm. On 30-SEP-2015, sample was collected from the scab for polymerase chain reaction (PCR) test. Follow-up information has been received on 14-OCT-2015. A scab sample was sent for varicella zoster virus (VZV) PCR test and the result on 07-OCT-2015 showed that it was a wild-type strain. The patient was on oral antivirals prior to specimen collection. Follow up information has been on 03-NOV-2015. The patient requested for compensation for medical bills associated with adverse event. No further adverse event or product quality complaint has been reported. Follow up information has been received from the physician on 11-JAN-2016 concerning the White patient. The patient did not have any illness at the time of vaccination. On 15-SEP-2015 (previously reported as 01-SEP-2015), the patient was vaccinated with ZOSTAVAX at a local pharmacy. The patient developed shingles in leg which was diagnosed approximately on 06-OCT-2015 (reported as 3 weeks after ZOSTAVAX given). The patient was treated with antiviral. The patient also complained about some persistent leg pain since an unknown date. The causality was not reported. Follow-up (F/U) information has been received on 15-AUG-2017 from a lawyer regarding a case in litigation, concerning a 62 year old male. The patient (pt) was inoculated with ZOSTAVAX on or about 01-SEP-2015 (previously reported by physician as 15-SEP-2015), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the pt to contract a persistent strain of herpes zoster (previously reported onset of 21-SEP-2015). On or about 10-OCT-2015, the pt was treated by a physician for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 12-OCT-2015, the pt was treated by another physician for ongoing and worsening symptoms of neuropathic pain and shingles. On or about 02-NOV-2015, the pt was treated by another doctor for severe and persistent herpes zoster, which had resulted in seborrheic dermatitis and other complications. The pt has been prescribed Lipoderm and Lidocaine for management of his persistent and long-term nerve pain and symptoms. As a direct and proximate result of these malfunctions, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. It has been determined that case # US-009507513-1509USA012715 is a duplicate of case # US-009507513-1509USA012674. Therefore, case # US-009507513-1509USA012715 is being deleted from our files and the cases are consolidated into case # US-009507513-1509USA012674. Additional information has been requested. Sender's Comments: MERCK 1509USA012674: Mfr number.