Age: 82.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Condition aggravated, Herpes zoster, Inappropriate schedule of product administration, Insomnia, Pain
Clinical narrative: Diagnosed with shingle (herpes zoster; Pain on her right side; Rash at the right side at her waist line from the never at the center of her back; Not able to sleep; This case was reported by a consumer via other manufacturer and described the occurrence of shingles in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included dupilumab for atopic dermatitis.   The patient's past medical history included pruritus (for a couple of years first with head then breaking out all over her body), swollen joints, exfoliation, rash (rash all overy body), ankle swelling and swelling of feet. Concurrent medical conditions included heart disorder, polymyalgia rheumatica, cellulitis and atrial fibrillation. Concomitant products included digoxin and prednisone.   On 11th December 2020, the patient received Shingrix. On 11th February 2020, the patient started dupilumab (subcutaneous) 600 mg 4 times daily (600 mg daily). In 2020, the dose was changed to an unknown dose and frequency. On 25th December 2020, 14 days after receiving Shingrix and an unknown time after starting digoxin and Valtrex, the patient experienced shingles, pain, rash and difficulty sleeping. The patient was treated with valaciclovir hydrochloride (Valtrex), bumetanide and pregabalin (Lyrica). Dupilumab was discontinued. On an unknown date, the outcome of the shingles, pain, rash and difficulty sleeping were recovering/resolving.   It was unknown if the reporter considered the shingles, pain, rash and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and started with pain on her right side, rash at the right side at waistline from the never at the center of back, because of the pain the patient was not able to sleep and was diagnosed with shingle and most of skin was cleared off with the exception of back of neck and head, which was still itching, while the patient was treated with dupilumab Dupixent delivered via dupilumab pre-filled syringe.  On 25th December 2020, 14 days after the patient experienced shingles, pain, rash and difficulty sleeping. The concomitant medications included Digoxin for Atrial fibrillation and to prevent clog and Prednisone for cellulitis all over. On 11th February 2020, the patient started taking dupilumab injection 600 mg once via subcutaneous route with an unknown strength, batch number and expiry date followed by 300 mg every other week since an unknown date in 2020 via dupilumab pre-filled syringe for atopic dermatitis.  In the COVID19 crisis, the batch number and expiration date were not requested. On 25th February 2020, the patient complained that ankles looked great but they were swollen joint swelling, had swelling in feet, the left worse than right, from the ankles to the toes peripheral swelling and condition aggravated. The reporter would not give up the patient Dupilumab.  On 09th December 2020, the doctor prescribed a Shingrix vaccination and on 11th December 2020 the patient received 1st dose of Shingrix. On unknown date, the doctor advised to temporarily stop Dupilumab. The patient was getting better.  At the time of report, Dupilumab was discontinued.  No additional information available at the time of the report. It was further reported that patient called the program and they told the consumer to wait 24 hours before taking the vaccine, waited 48 hours.  The patient had been off the antiviral medication that was prescribed for 10 days and wondered about resuming dupilumab and did missed the dose that was scheduled on 06th January 2021.  The nurse advised the consumer that once the dose exceeds the 7 days window, the patient should wait the another scheduled due date, but was encouraged the consumer to discuss resuming with the physician. No lab data was reported.