Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Fatigue, Herpes zoster, Hypotension, Neuralgia
Clinical narrative: Got 2nd dose on 14Aug 2022, now shingles/suspected vaccination faliure; Case of Shingles; feeling tired; Neuropathic pain; painful burning; light headed and dizzy; Turned purple all over; low blood pressure; Rash, visited Urgent Care spread on arms and legs; This serious case was reported by a pharmacist 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 M5469, expiry date 01-SEP-2023), (batch number MS469, expiry date 01-SEP-2023) and (batch number 753E5) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had cases of shingles in the past).   On 14-AUG-2022, the patient received the 2nd dose of Shingrix (left arm). On an unknown date, the patient received the 1st dose of Shingrix. On 15-AUG-2022, 1 days after receiving Shingrix, the patient experienced rash (Verbatim: Rash, visited Urgent Care spread on arms and legs), pain burning (Verbatim: painful burning), light headedness (Verbatim: light headed and dizzy), skin discoloration (Verbatim: Turned purple all over) and low blood pressure (Verbatim: low blood pressure). On an unknown date, the patient experienced vaccination failure (Verbatim: Got 2nd dose on 14Aug 2022, now shingles/suspected vaccination faliure) (serious criteria GSK medically significant), shingles (Verbatim: Case of Shingles), tiredness (Verbatim: feeling tired) and neuropathic pain (Verbatim: Neuropathic pain). The patient was treated with amitriptyline and intravenous fluid (nos) (Intravenous Fluids). The outcome of the vaccination failure, shingles, rash and neuropathic pain were unknown and the outcome of the tiredness, pain burning, light headedness, skin discoloration and low blood pressure were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, tiredness, rash, neuropathic pain, pain burning, light headedness, skin discoloration and low blood pressure to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, tiredness and neuropathic pain to be related to Shingrix.     It was unknown if the company considered the vaccination failure, shingles, tiredness, rash, neuropathic pain, pain burning, light headedness, skin discoloration and low blood pressure to be related to Shingrix. It was unknown if the company considered the vaccination failure, shingles, tiredness and neuropathic pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-MAY-2023 The physician reported that patient got the Shingrix vaccination and had a case of shingles with neuropathy pain. One day after the vaccination patient experienced low blood pressure, a rash that spread on her arms and legs, painful burning, light headed and dizzy and turned purple all over when she was on the way to her work. The patient was feeling tired. On 14th August 2022, the patient administered unknown product of Antihistamines and unknown Steroids as concomitant drugs for 3 months. The physician did not know how long the patient was on the antihistamines. The patient was prescribed with Amitriptyline and Intravenous fluid of unknown product in the immediate care facilityas treatment drug. The patient visited to urgent care for treatment because of a rash that was developed after the vaccine. No specific information about the burning was provided. No specific time frame was provided about how long these adverse events lasted. Report was provided with limited information.  Reporter reported everything the physician had to provide. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.