Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a female patient of unknown age. The patient had no pertinent medical history and no concomitant medications. The patient's drug reactions or allergies were not reported. On 29-FEB-2016, the day before the dose of ZOSTAVAX was administered, the patient noticed rash on her body. On 01-MAR-2016, the patient was vaccinated with a dose of ZOSTAVAX injection, lot # reported as L039095, expiration date: 08-JAN-2017 (dose, route and site of administration were not reported). On 03-MAR-2016 (also reported as today), the patient presented a prescription for VALTREX and told the pharmacist that she "thought that ZOSTAVAX would treat her rash". The patient consulted her physician on the same day to seek treatment for the rash and was diagnosed with shingles. It was unknown for certain if the patient had shingles before receiving ZOSTAVAX. At the time of this report, the patient did not take any doses of VALTREX. The outcome of shingles was not reported. The reporting pharmacist did not assess the causality between the event and vaccination with ZOSTAVAX. Lot # L039095 has been verified to be a valid lot number for ZOSTAVAX. Follow-up information has been received from the reporting pharmacist on 26-MAY-2016, concerning 61 years old (also reported as 62 years old) patient. The patient's medical history included chickenpox. The patient had no adverse events following prior vaccinations, no recent exposure to chickenpox or herpes zoster (HZ), no pre-existing allergies, birth defects or other medical conditions. On 28-FEB-2016 (also reported as one day prior the vaccination), the patient experienced itching of stomach (above navel) and back, which turned out to be shingles rash. The patient did not known that she had shingles and sought vaccination without telling about itching. On 01-MAR-2016 in the afternoon, the patient was vaccinated with the first dose of ZOSTAVAX 0.65 ml, subcutaneously in the left upper arm. On an unknown date in March 2016, the patient experienced herpes zoster with T9 and T10 dermatomes of the thoracic region involved. On an unknown date in March 2016, the patient experienced pain at two lesions, which lasted for 1 month. The pain was assessed as 10 (maximum pain) on a 0-10 scale. The number of lesions, which the patient had was reported as 2. The patient had no fever. No lab diagnostic studies were performed. The specimen was not collected for polymerase chain reaction (PCR) analysis. On 02-MAR-2016 (reported as the next day), the patient visited her physician and received VALTREX as treatment for shingles. The outcome of multi-dermatomal herpes zoster and pain at lesions was reported as recovered on 31-MAR-2016. The relatedness between these events and the vaccination with ZOSTAVAX was not reported. Upon internal review, the event of multi-dermatomal herpes zoster was determined to be medically significant. Additional information is not expected as all scheduled correspondence was received. Patient's details, product, events and narrative were updated.