Age: 60.0
Sex: F
Vaccine: FLU4, VARZOS, VARZOS, FLU4, VARZOS
Symptoms: Skin burning sensation, Sleep disorder, Urticaria, Viral infection
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 61 year old female patient. The patient's concurrent conditions included allergy to red dye. Historical drugs included unspecified psychiatric medications for anxiety. On 09-SEP-2016, the patient was vaccinated with ZOSTAVAX (lot # L044529, expiration date: 09-FEB-2017) 19400 plaque-forming units (PFU) 0.65 ml, subcutaneously. Concomitant therapy included FLUZONE administered on the same day. On an unknown date in September 2016, the patient experienced a reaction described as 'welts on the patient's stomach that turned into open areas: also a red face, neck and chest.' The pharmacist reported that the patient sought medical attention at an unspecified emergency room on 15-SEP-2016 at which an unspecified treatment was provided and by calling pharmacy and speaking with another associate pharmacist on 16-SEP-2016. The outcome of the events and causality assessment were not provided. Follow up information was received from the patient via Poison Control Center on 02-NOV-2016. The patient's medical history included being healthy before the ZOSTAVAX. The patient's concurrent condition included anxiety and "fights with cholesterol". The patient reported she received ZOSTAVAX, 1 dose subcutaneously one time for shingles prevention on 09-AUG-2016 (previously reported as 09-SEP-2016). The patient's concomitant medications include lorazepam and other unknown medications. The patient's past drug history was unknown. The patient reported she received the "bad vaccine" shot from a pharmacy. On 10-AUG-2016, she started to get very sick and developed shingles and it felt like a fire under her skin. On an unknown date in 2016, since developing shingles, she reported getting progressively more ill and she feared for her life. She reported the virus attacked her body of her right side. She had lost muscle tone in her right arm and her right hand was almost immobile. She also reported she could hardly hold her head up and her clavicle was affected. The virus also attacked the lymph nodes in her right arm. She had muscle atrophy and could not even hold a glass. Her whole right side was debilitated. The patient reported being in the emergency room (ER) twice to be treated for the pain since it was not controlled by medication. She was in the ER on 11-OCT-2016 and again on 28-OCT-2016. In the ER, her diagnosis was listed as shingles and cervical radiculopathy. The patient reported so much pain that she could not sleep and stating the pain was "unbelievable". She got some relief from EPSOM salt salt baths and ice. On 02-NOV-2016, she reported she had an appointment at the "Spinal Center" and was started on tramadol and gabapentin which she thought might be giving her some relief. She was currently waiting on insurance to be able to have a procedure on her neck. She stated she wanted to get better but was continuing to get worse and didn't want to be crippled from getting a shot. The patient's laboratory data was unknown. As of 02-NOV-2016, the patient no longer received ZOSTAVAX and continued to experience the events and was continuing to get worse. The causality between the events and the ZOSTAVAX was not reported. The reporter considered the events as medically significant. As of 28-NOV-2016, all telephone attempts made to obtain follow up information have been unsuccessful. Follow up information has been received on 12-DEC-2016. Additional information is not expected as all scheduled correspondence has been unsuccessful. Sender's Comments: MERCK 1609USA009446: Mfr number.