Age: 71.0
Sex: M
Vaccine: COVID19, PPV, VARZOS, VARZOS
Symptoms: Pain, Rash, Skin burning sensation, Vaccination failure
Clinical narrative: Stabbing pain under his left breast; Cannot sleep due to pain; Skin was burning; Body was burning / burning on his back; Small area about the size of a quarter where there was a rash; The pain was debilitating; Pain; Got shoingles after two doses of Shingrix / Suspected vaccination failure; Shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, PNEUMOCOCCAL VACCINE (PNEUMONIA SHOT) for prophylaxis and COVID-19 VACCINE (COVID 19 BOOSTER) for prophylaxis.   The patient's past medical history included viral infection (sick with a funky virus 2 months ago which was like a bad cold/flu and was recovered). Previously administered products included Covid vaccine (prior vaccination with initial Covid series). Concurrent medical conditions included immunocompromised. Additional patient notes included patient had no history of prior shingles outbreak.   On an unknown date, the patient received the 2nd dose of Shingrix. In FEB-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received PNEUMONIA SHOT and COVID 19 BOOSTER. In MAY-2023, less than 2 years after receiving Shingrix and between 1 and 2 years after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Got shoingles after two doses of Shingrix / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). On an unknown date, the patient experienced breast pain (Verbatim: Stabbing pain under his left breast), insomnia (Verbatim: Cannot sleep due to pain), burning skin (Verbatim: Skin was burning), burning sensation (Verbatim: Body was burning / burning on his back), rash (Verbatim: Small area about the size of a quarter where there was a rash), debility (Verbatim: The pain was debilitating) and pain (Verbatim: Pain). The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)) and allergy medication {nos} (Allergy Pill). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the breast pain, insomnia, burning skin, burning sensation, rash, debility and pain were not reported.   The reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the reporter considered the breast pain, insomnia, burning skin, burning sensation, rash, debility and pain to be related to Shingrix. It was unknown if the reporter considered the burning skin, burning sensation, rash and pain to be related to Shingrix.     The company considered the vaccination failure and shingles to be related to Shingrix and Shingrix. It was unknown if the company considered the breast pain, insomnia, burning skin, burning sensation, rash, debility and pain to be related to Shingrix. It was unknown if the company considered the burning skin, burning sensation, rash and pain to be related to Shingrix.   Additional Information: GSK receipt date: 18-MAY-2023 This case was reported by patient.  The patient received both doses of Shingrix in 2022 and did not recall the exact dates. He thought that he got the first shot in February 2022 and the second shot 2 to 6 months later at a retail pharmacy.  The pharmacy would had a record of the lot numbers and exact dates of administration as he did not had that information. In 2023, the patient received Covid booster and pneumonia shot on same day about 2.5 to 3 months before reporting. About one week before reporting, this patient developed shingles.  It started with a burning on his back and his skin was burning. The patient stated that his body was burning. There was no rash.  He took an unspecified allergy pill.  The next day the burning was worse and came around the front of his body.  There were no blisters or rash but there was a small area about the size of a quarter where there was a rash.  The patient had stabbing pain under his left breast.  He felt like he was having a heart attack because the pain was so severe it was like someone had stuck him with a knife. The patient stated that pain was crippling and debilitating.  He could not sleep due the pain and he was walking around like a zombie due to the pain.  He was diagnosed with shingles and was prescribed unspecified antiviral medication.  The shingles episode had not yet resolved. It was unknown if the reporter considered the adverse events to be related to Pneumococcal vaccine (pneumonia shot) and Covid-19 vaccine (covid 19 booster). The reporter consented to follow up. This case was considered as suspected vaccination failure as detail regarding laboratory confirmation regarding shingles were unknown at the time of reporting.