Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Hyperaesthesia, Pain, Pain in extremity
Clinical narrative: Feels like a shingles flareup / Suspected vaccination failure; Feels like a shingles flareup; Pain rotates from different areas mainly upper body extremities / Tenderness in arms and legs; Burning sensation with pain; Left arm it's very sensitive to touch and now right arm is sensitive to touch/Right shoulder blade because it was so tender to touch and sensitive; Tender to touch; Pain rotates from different areas; This serious case was reported by a nurse via call center representative and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number DC434) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number D4CZ3, expiry date 10-APR-2023) for prophylaxis.   On 21-MAR-2022, the patient received the 2nd dose of Shingrix (right arm). On 06-JAN-2022, the patient received the 1st dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Feels like a shingles flareup / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Feels like a shingles flareup), pain in extremity (Verbatim: Pain rotates from different areas mainly upper body extremities / Tenderness in arms and legs), burning sensation (Verbatim: Burning sensation with pain), touch sensitivity increased (Verbatim: Left arm it's very sensitive to touch and now right arm is sensitive to touch/Right shoulder blade because it was so tender to touch and sensitive), tenderness (Verbatim: Tender to touch) and pain (Verbatim: Pain rotates from different areas). The patient was treated with lidocaine and topical steroid nos (Topical Steroids). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain in extremity, burning sensation and pain were not resolved and the outcome of the touch sensitivity increased and tenderness were resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain in extremity, burning sensation, touch sensitivity increased, tenderness and pain to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, pain in extremity, burning sensation, touch sensitivity increased, tenderness and pain to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 01-June-2023 The patient self-reported this case. The patient had been having burning sensation with pain that rotates from different areas, mainly her upper body extremities.  The nurse practitioner stated after the first injection, thought it was an outbreak on right shoulder blade because it was so tender to touch and sensitive.  There was no outbreak or flare up, it eventually went away because she put topical steroid and lidocaine on it.  Just recently under the left arm it was very sensitive to touch and now right arm was sensitive to touch.  The nurse practitioner mentioned assumed she was getting an outbreak but never developed any eruption.  The patient just applied topical steroids and lidocaine.  The reporter inquired if any additional information available, upon escalation expert noted nurse practitioner stated feels like a shingles flare up under shoulder blade, arms but rotates and experienced it in legs, as well.  The patient was on over the counter cream and lidocaine 4 percent seemed to help the pain sensation. The reporter did not provide date of birth, lot number, or expiration date of product.  The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were unknown at the time of reporting.