Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Injection site pain, Injection site warmth, Insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 75-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 24th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 24th March 2018, immediately after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain, headache, chills, muscle pain and nausea. On 29th March 2019, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and blister. On an unknown date, the patient experienced nerve pain, injection site warmth, blister, gas, fatigue, scar, insomnia, rash, upset stomach, injection site pain, headache, chills, muscle pain, nausea and injection site warmth. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the vaccination failure, shingles, nerve pain, gas, fatigue, scar, insomnia, rash, upset stomach and blister were unknown and the outcome of the injection site pain, headache, chills, muscle pain, nausea, injection site warmth, blister, injection site pain, headache, chills, muscle pain, nausea and injection site warmth were recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles, nerve pain, injection site pain, headache, chills, muscle pain, nausea, injection site warmth, blister, gas, fatigue, scar and rash to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure, shingles, nerve pain, gas, fatigue, insomnia, upset stomach, injection site pain, headache, blister, chills, muscle pain, nausea and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX in the left arm and it pinched when she received the 1st dose of the SHINGRIX vaccine. Within a couple hours after receiving the 1st dose, the patient began to experience headache, chills, muscle aches and nausea. The patient experienced the same symptoms after receiving the 2nd dose of SHINGRIX. The 2nd injection pinched upon administration and she experienced a headache, chills, muscle aches, and nausea. It took two to three three days for all other symptoms to resolve after both the first and second dose of the SHINGRIX vaccine. The patient's arm at the injection site was warm with both injections and resolved within a day. Three months after receiving the first dose she developed a line of blisters on her abdomen that oozed. The symptoms resolved within 2 and half to 3 weeks and she the patient had a scar on her abdomen from the blisters. On Friday, 29th March 2019, the patient again found a line of blisters along the right side of her body where her arm contacts the skin before the right breast. A few days before the blisters appeared, she had a headache, nausea, and muscle aches. The patient could not sleep on her side because it hurt. When the patient moved her right arm it hurts her right side where the blisters were located. The patient went to her physician on the date of reporting and was diagnosed with shingles. The physician said that what the patient thought was muscle pain was really nerve pain. The patient was also experiencing gas with the nausea. The patient had consented to follow up. The patient gave contact details of the treating physician. The case US2019GSK057863 was identified as duplicate of case US2019059278. Case US2019GSK057863 would be deleted and all future correspondence will be added in the case US2019059278 which stands as case of record for this patient.