Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypokinesia, Injection site pain, Insomnia, Joint swelling, Malaise
Clinical narrative: Initial report received on 11 January 2007 from another manufacturer, report number WAES0611USA07048. The initial reporter to this manufacturer had been a health care professional. Verbatim from the report: "Information has been received from a 65 year old male consumer with no known allergies and a history of a heart attack in August 2006, who on 02-Nov-2006 was vaccinated with a dose of varicella-zoster virus vaccine live. Concomitant therapy included unspecified "heart medication". On 04-Nov-2006 the patient went to the emergency room because he was having severe pain in his hands and shoulder. The patient was given acetaminophen (+) hydrocodone bitartrate (VICODIN), unspecified blood work was done, and x-rays of his shoulder and hand were done (results not reported). The patient was sent home from the emergency room after 4 hours. On the following Monday or Tuesday the patient saw the physician who told him to take ibuprofen (ADVIL) or acetaminophen (TYLENOL). At the time of the report the patient continued to have pain in his hand and shoulders, and swelling in his hands and wrist. The patient was complaining of pain at the injection site when it is pressed, however he did not have any redness or swelling at the site. The patient was reported to be recovering on therapy. There was no product quality compliant involved. No further information was provided. "Additional information had been received from a registered nurse, a medical assistant and medical records concerning this 65 year old white male with herpes simplex, a procaine hydrochloride (NOVOCAIN) allergy and a history of heart attack, shingles, coronary artery disease, hypertension, and hyperlipidemia who on 02-Nov-2006 was vaccinated SC in the right arm with a dose of varicella-zoster virus vaccine live (lot#652936/0981F). Vaccination the day before on 01-Nov-2006 included a second dose of influenza virus split virion 3v vaccine inactivated (FLUZONE) (lot#U2202AA) given IM in the left deltoid. Concomitant therapy included metoprolol (PLAVIX), niacin (NIASPAN), etzatimibe (+) simvastatin, levalbuterol hydrochloride (XOPENEX) inhaler and prn acyclovir. On 04-Nov-2006 the patient called the physicians office stating that a couple days after vaccination, in the arm he received the flu vaccine (left arm) he developed red spots that were swollen and painful. On 04-Nov-2006 the patients hand was red and swollen. The patient was advised to go to the emergency room (ER) for evaluation and to possibly rule out a spider bite. Labs were done when the patient was in the ER, the MCHC was slightly high at 36.2 g/dl (reference range = 30.0-36.0), the sed rate was high at 27 mm/hr (reference range 0-20). All other labs were within the normal, reference range. On 06-Nov-2006 the patient called the office and reported that he went to the ER for a reaction (severe left hand pain and swelling) to the vaccines that he received. On 06-Nov-2006 the patient was having some faint flushing and his right hand was also swollen. The patient was given prednisone 20 mg to take q12 hours. The patient was also advised to elevate his hand. On 10-Nov-2006 the patient was seen in the office for follow-up. At this time the patient was given the diagnosis of arthralgias and some myalgias and the patient "just felt terrible in general", thought the patient was actually "feeling a little better" that day. The patient's physical exam was unremarkable though he had some soreness over the wrists and a little bit over the ankles. The patient was prescribed prednisone 60 mg x 2 days, 50 mg x 2 days, "on down". On 21-Nov-2006 the patient called the office to report that he was out of prednisone and that the injection sites were still "so sore he could hardly lift his arm", he was having some tingling and the pain was causing him to lose sleep, there was no redness or swelling at that time. The patient was prescribed hydrocodone bitartrate (+) ibuprofen (VICOPROFEN) 1-2 q4-6 hrs prn, and labs were ordered which were within the normal reference range. On 24-Nov-2006 the patient was seen in the office for follow-up. The patient stated that he actually got some sleep the night before and felt better that day. The patient had no numbness, tingling, weakness or rash. It was reported that there were no joint deformalities or rashes and that his range of motion was excellent. At that time the patient was advised to alternate ibuprofen (ADVIL) and acetaminophen (TYLENOL). On 27-Nov-2006 the patient called the office to report that her continued to have side effects after receiving varicella-zoster virus vaccine live (lot#652936/0981F). The patient was advised to see a rheumatologist. It was also reported that the patient was referred to a specialist in the middle of December. The reporter considered the patient's events to be serious for significant incapacity. Additional information has been requested. This is an amended report. Laboratory data has been updated.