Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Burning sensation
Clinical narrative: Suspected vaccination failure; shingle episode; Pain; unbearable itching; burning sensation; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (It developed from the tip of my left fingers to the base of the neck). Concomitant products included amlodipine and prazosin.   On 30-JUL-2024, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On 06-AUG-2024, 7 days after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingle episode). In AUG-2024, the patient experienced pain (Verbatim: Pain), pruritus (Verbatim: unbearable itching) and burning sensation (Verbatim: burning sensation). The patient was treated with cetirizine hydrochloride (Zyrtec) and acrivastine (Benadryl). The outcome of the vaccination failure was not reported and the outcome of the shingles, pain, pruritus and burning sensation were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus and burning sensation to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be unrelated to Shingrix. It was unknown if the company considered the shingles, pain, pruritus and burning sensation to be related to Shingrix and Shingrix. It was unknown if the company considered the vaccination failure to be related to Shingrix.   Additional Information: GSK receipt date: 30-AUG-2024 The reporter reported that he/she had a shingle episode a few years ago it developed from the tip of my left fingers to the base of the neck. It lasted for approximately 5 weeks. The reporter stated that he/she celebrated his/her 55th birthday last march and decided to get a vaccine. He/she was injected product beginning of this summer and he/she had received the second shot approximately 4 weeks ago. Since then, he/she had developed symptoms that resemble the Shingle episode he/she had a few years ago. It seems that it comes every night the pain, the unbearable itching, the burning sensation was the same as what he/she experienced during his/her shingles episode. His/her skin was not blistering the same way though he/she tried to get rid of this with antihistamine like Zyrtec or Benadryl.  Initially he/she thought it was a normal reaction to the vaccine. But it was not a month now and it did not go away. The reporter stated that can you please help me for this. 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.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about the clinical description, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine Shingrix(1 and 2 dose).