Age: 63.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Haemorrhoids, Immediate post-injection reaction, Lipoma, Muscle discomfort, Product administered at inappropriate site
Clinical narrative: had bands that ruptured and caused an ulceration; suffered a stroke; shoulder area is very sore; had a golf ball size lump on the anterior side of the shoulder; had problems with bowel movements; hemorrhoids; something has hit her muscle; Shingrix vaccine and the Flu vaccine at the same time in her left upper arm; extreme discomfort; Lipoma; This case was reported by a consumer via call center representative and described the occurrence of ulcer in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   The patient's past medical history included gallbladder removal. Concurrent medical conditions included diabetes, blood pressure high and stroke.   On 14th August 2020, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2020-2021 season. On 14th August 2020, immediately after receiving Shingrix and an unknown time after receiving Influenza vaccine Quadrivalent 2020-2021 season and ibuprofen, the patient experienced discomfort. In August 2020, the patient experienced lipoma. On an unknown date, the patient experienced ulcer (serious criteria hospitalization), stroke (serious criteria GSK medically significant), shoulder soreness, axillary lump, bowel discomfort, hemorrhoids, muscle discomfort and vaccine administered at inappropriate site. The patient was treated with ibuprofen, non-drug therapy (Heat Therapy) and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the ulcer, stroke, discomfort, shoulder soreness, lipoma, axillary lump, bowel discomfort, hemorrhoids and muscle discomfort were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the ulcer, stroke, discomfort, shoulder soreness, lipoma, axillary lump, bowel discomfort, hemorrhoids and muscle discomfort to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not provided. The patient had a stroke on 4th June 2018 and previously had her gall bladder removed. The patient reported that she received the Shingrix vaccine and the Flu vaccine at the same time in her left upper arm shoulder area on 14th August 2020. The patient experienced extreme discomfort which started immediately in her upper arm in the early part of the day. The patient started to use heat and ice the shoulder and took Ibuprofen.   A week after the injections, she had a golf ball size lump on the anterior side of the shoulder.  The patient had an x-ray and it showed nothing.  They did an ultrasound within days of the x-ray and she was diagnosed with Lipoma two weeks after receiving both injections.   The lump did not move and was not soft and mushy.  Her shoulder area was very sore like something has hit her muscle and it would not resolve.   The patient received the Shingrix in the center of her shoulder and the lump was on the side anterior medial.  The patient didn't pay attention where she received the Flu vaccine.   The patient recently had problems with bowel movements and hemorrhoids.  She had bands that ruptured and caused an ulceration and she was hospitalized from 2nd October 2020 to 4th October 2020 because of the rupture. The patient stated that her hospitalization had nothing to do with the Shingrix vaccination.  The patient also stated that she just suffered a stroke but no additional details were provided.  The patient reported that her side effects are still unchanged. The reporter consented to follow up.