Age: 61.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Influenza like illness, Injection site pain, Malaise
Clinical narrative: Suspected Vf; he had a case of shingles; Sick; feeling like a deep sun burn; itchy, raw; tender areas; There is also a small spot on his left breast; small spot in the area of breast; he developed some labored breathing; his first shot in his left arm in February 2020 and then received his second shot in his right arm 6 weeks later; flu like symptoms after traveling; fever; headache; fatigue that lasted a week; had pain at the injection site; had pain at the injection site and STIFFNESS  in his arm; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 61-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 gout (had gout in the past).   In February 2020, the patient received the 1st dose of Shingrix. In March 2020, the patient received the 2nd dose of Shingrix. In March 2020, not applicable after receiving Shingrix and less than a month after receiving Shingrix, the patient experienced influenza-like symptoms and drug dose administration interval too short. On 12th April 2020, the patient experienced labored breathing. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, injection site pain, limbs stiffness, fever, headache, fatigue, sickness, burning sensation, pruritus, tenderness, spot-like rash and breast nodule. On an unknown date, the outcome of the vaccination failure, sickness, burning sensation, pruritus, tenderness, spot-like rash, breast nodule and drug dose administration interval too short were unknown and the outcome of the shingles and labored breathing were recovering/resolving and the outcome of the injection site pain, limbs stiffness, influenza-like symptoms, fever, headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, injection site pain and limbs stiffness to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles, influenza-like symptoms, labored breathing, fever, headache, fatigue, sickness, burning sensation, pruritus, tenderness, spot-like rash and breast nodule to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in left arm and 2nd dose of Shingrix in right arm. The patient received 2nd dose of Shingrix 6 weeks later in the beginning of March 2020 after 1st dose, which led to shortening of vaccination schedule. After vaccination with 1st dose, the patient had pain at the injection site and stiffness in his arm  that lasted for a week. In early March, the patient, his wife and son  developed flu like symptoms after traveling and were sick with fever, headache and fatigue that lasted a week. Approximately 4 weeks ago, from the date of reporting, the patient developed some labored breathing in his right lung. The doctor stated that, the patient had case of shingles and were presented as itchy, raw, tender areas and described it asfeeling like a deep sun burn. The area affected includes right breast on nipple, under right arm and around part way on right shoulder blade.  There is also a small spot on left breast. The patient had COVID 19 test negactive. The patient did not have blisters. The reporter stated that the patient did not experienced any symptoms after 2nd dose of Shingrix. The reporter consented to follow up.