Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Vaccination failure
Clinical narrative: Still experiencing needle poking like sensation; Got 2 doses in 2019; Oct2021 first outbreak, massive; Oct2021 first outbreak, massive, not completely resolved; Sore arm with both doses; Hot arm; Swollen arm; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included pain in arm, swelling arm and skin warm.   On 24th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 15th February 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, skin warm and swelling arm. In October 2021, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced tingling sensation. The patient was treated with valaciclovir hydrochloride (Valtrex), gabapentin, paracetamol (Tylenol) and lidocaine. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and tingling sensation were not recovered/not resolved and the outcome of the pain in arm, skin warm and swelling arm were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain in arm, skin warm, swelling arm and tingling sensation to be related to Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient. The patient received 2 doses of SHINGRIX in 2019. In October 2021, the patient experienced first case of outbreak of shingles. She received both doses of SHINGRIX at 2 different pharmacies. Both doses were administered on left arm and intramuscularly on respective days. The patient also experienced sore arm that was hot and swollen within 24 hours after getting the vaccination. Sore arm occurred with both doses, but the severity was less with second dose compared to the first dose. Sore arm (swollen and hot) was resolved within 2 to 3 days. She does not have exact date when the outbreak of shingles occurred in October 2021. However, the patient was prescribed Valtrex for 7 days, gabapentin 100mg at bedtime and Tylenol 1000mg every 6 hours. Later, the HCP reduced Tylenol to 500mg every 4 hours. Currently, she was using Lidocaine as the shingles were not completely resolved.  The patient was still experiencing needle poking like sensation. Furthermore, the patient stated that the shingles were on left front side of chest and down to wrist. She elaborated as massive outbreak. The reporter gave a consent to follow-up. However, she does not have an email address to HCP. The patient did not have the lot/expiry dates and dosage for both doses of SHINGRIX. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation of shingles was not provided. The case has been linked with case US2021AMR233470 reported by same reporter for same patient for Valtrex.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR233470:same reporter