Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion, Varicella virus test positive
Clinical narrative: full blown shingles all over the body/Herpes zoster; patient was administered 0.5ml of Zostavax; This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. In August (reported as "last week"), the patient was vaccinated with a single dose of 0.65 ml zoster vaccine live (ZOSTAVAX) (lot# not reported) subcutaneous. No other co-suspects were reported. No concomitant medications were reported. On 27-AUG-2012 the patient experienced several lesions on the right torso area. There was no treatment information because patients had not yet been seen by the health professional. The patients had sought unspecified medical attention. The outcome was reported as not recovered.  Follow up information has been received from the nurse practitioner referring to the patient, the nurse stated that the patient "now had full blown shingles all over the body." The nurse would now start treating the patient with acyclovir and acetaminophen (TYLENOL).  Follow up information has been received on 19-SEP-2012 from a nurse practitioner concerning a 75 year old female patient with drug allergy to carisoprodol (SOMA), cyclobenzaprine hydrochloride (FLEXERIL) and hydrocodone and a history of chickenpox as a small child and no recent exposure to chickenpox and shingles. The patient was vaccinated with a single dose of zoster vaccine live (ZOSTAVAX), 0.5ml, subcutaneously in left deltoid (lot number reported as 0071AE, expiration date 03-APR-2013) on 24-AUG-2012.  No other co-suspects were reported. Concomitant medications included rosuvastatin calcium (CRESTOR), amlodipine besylate (NORVASC) and aspirin (aspirin).     On 24-AUG-2012, the patient experienced typical herpes zoster lesions along dermatome below right breast and macules. On that same date the patient presented systemic symptoms of sweat, and on an unspecified date nausea. On 25-AUG-2012, the patient developed vesicular lesions, described also as rash papular with 10 lesions, along dermatome below right breast and around to spine and lesions to mid scapula. The patient had a maximum body temperature in 2012 between 98.6  101, also reported 98 (units not provided); a pain scale was reported as 8. On 29-AUG-2012, the patient had multiple papules and vesicles. On 27-AUG-2012, the patient was given acyclovir 200 mg as a treatment for adverse events.  The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the OKA/Merck vaccine strain. The patient had taken 2 cultures one on 25-AUG-2012 from a papule around chest below right breast and another on 27-AUG-2012 from vesicle (results pending). The patient's maximum temperature was 98.6 F to 101 F. Pain was measured as 8.  No photo was taken.  At the time of the report the patient had not yet recovered.   The relatedness for adverse events was not reported for Zoster Vaccine Live (ZOSTAVAX).      Internal information received on 05-NOV-2012, confirmed that polymerase Chain Reaction (PCR) from second specimen taken on 27-AUG-2012 from vesicle, contained the wild-type varicella zoster virus.  Lot number 0071AE is an invalid lot number for Zoster Vaccine Live (ZOSTAVAX).  Follow up information has been received from a lawyer on 29-AUG-2019 regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding medical history, concurrent condition, or concomitant medication. On or about 04-AUG-2012 (conflicting information previously reported as 24-AUG-2012 by a nurse), the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to zoster vaccine live (ZOSTAVAX) inoculation (unknown date), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization (conflicting information previously reported that the patient was not hospitalized), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was considered as not resolved. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).    It has been determined that case # US-009507513-1909USA001525 is a duplicate of case # US-009507513-1209USA000128 Therefore, case # US-009507513-1909USA001525 is being deleted from our files and the cases are consolidated into case # US-009507513-1209USA000128.