Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Antiphospholipid antibodies, Autoimmune disorder, Borrelia test, Condition aggravated
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included sacroiliitis and shingles. Concurrent medical conditions included autoimmune disorder. In July 2018, the patient received the 1st dose of SHINGRIX. In August 2018, the patient received the 2nd dose of SHINGRIX. In August 2018, not applicable after receiving SHINGRIX and unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too short and vaccine administered at inappropriate site. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant), autoimmune disorder (serious criteria GSK medically significant), condition aggravated, shingles, blistery rash, hives, pain and depression. The patient was treated with acyclovir and dermatologicals nos (Cream (Nos)). On an unknown date, the outcome of the vaccination failure, autoimmune disorder, condition aggravated, shingles, hives, pain, depression, drug dose administration interval too short and vaccine administered at inappropriate site were unknown and the outcome of the blistery rash was recovered/resolved. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. It was unknown if the reporter considered the autoimmune disorder, condition aggravated, blistery rash, hives, pain and depression to be related to SHINGRIX. Additional details were provided as follows: The patient has a medical history of an autoimmune disease that cannot be identified. The patient did not have the dates of vaccination in front of her at the time of reporting. The patient stated that, her 1st shot was in her deltoid and she had no reaction. The patient stated that, she had her 2nd vaccine low on her right bicep and she thought the pharmacist technique added to her reaction to this injection, which led to inappropriate site of administration. The patient received 2nd dose of SHINGRIX earlier than recommended interval, led to the shortening of vaccination schedule. The patient experienced shingles for the ninth time right before new year's. She broke out in a blistered rash in the crack of her rear end on the left side. Each breakout the rash gets lower.  The patient treated it with acyclovir tablets and cream for about a week and it has healed but she was still in pain with her bilateral leg muscles from her hip down. The patient was now experiencing another flare of her autoimmune condition and was very depressed because she was hoping she would not have shingles again. The patient broke out in hives as big as saucers on her right arm down to her wrist which went away in about a week. Her nurse practitioner marked her as allergic to SHINGRIX as precaution on her chart. The patient has had tests for rheumatoid arthritis, lupus, lymes, etc. This case was considered as suspected vaccination failure as time to onset for the event and laboratory confirmation was unknown.