Age: 63.0
Sex: M
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Injury, Malaise
Clinical narrative: Kidney stones; Injection site warmth/Recurrent warmth around injection site; Injection site itching/Recurrent itchiness on injection site,; Injection site redness/Recurrent red spot on injection site; Skin bleeding/Skin more susceptible to bleeding/skin bleeding worsened; Haemorrhage purpuric/purpura spots on forearms/couple on knees/pupura bleeding; skin bleeding and Haemorrhage purpuric worsened; Fatigue; Feeling sick; Unable to eat; Lower abdominal pain; Accidental injury/bumped a door knob and had quater inch of spot bleeding on skin; This case was reported by a consumer via other manufacturer and described the occurrence of kidney stones in a 63-year-old male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included adalimumab (Humira) for psoriatic plaque, methotrexate for product used for unknown indication and apremilast (Otezla) for product used for unknown indication.   The subject's past medical history included renal stone (Started in 2013), hearing decreased and fatigue. Previously administered products included SHINGRIX with an associated reaction of nephrolithiasis (For tolerance of 1st dose, refer case US2022AMR103125). Concurrent medical conditions included skin bleeding and hemorrhage purpuric.   On 8th April 2022, the patient received the 2nd dose of Hz/su + AS01B (intramuscular). On 4th February 2022, the patient started Humira (subcutaneous) at an unknown dose and frequency. On 8th April 2022, the dose was changed to an unknown dose and frequency. On an unknown date, the patient started methotrexate at an unknown dose and frequency and Otezla at an unknown dose and frequency. In April 2022, less than a month after receiving Hz/su + AS01B, the patient experienced feeling sick, unable to eat and lower abdominal pain. On 21st June 2022, the patient experienced accidental injury. On an unknown date, the patient experienced kidney stones (serious criteria GSK medically significant), injection site warmth, injection site itching, injection site redness, skin bleeding, haemorrhage purpuric, condition aggravated and fatigue. Rechallenge with Hz/su + AS01B was positive. Humira was continued with no change. In April 2022, the outcome of the feeling sick, unable to eat and lower abdominal pain were recovered/resolved. On an unknown date, the outcome of the accidental injury and kidney stones were unknown and the outcome of the injection site warmth, injection site itching, injection site redness, skin bleeding, haemorrhage purpuric, condition aggravated and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the kidney stones, injection site warmth, injection site itching, injection site redness, skin bleeding, haemorrhage purpuric, condition aggravated, fatigue, feeling sick, unable to eat, accidental injury and lower abdominal pain to be related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comment: The reporter stated that, patient felt sick and experienced fatigue, skin more susceptible to bleeding/skin bleeding, recurrent warmth around injection site, kidney stones, recurrent itchiness on injection site, recurrent red spot on injection site, bad reactions to shingles vaccine and purpura spots on forearms/couple on knees/pupura bleeding. In 2022, the patient experienced fatigue, skin more susceptible to bleeding/skin bleeding, recurrent warmth around injection site, kidney stones, recurrent itchiness on injection site, recurrent red spot on injection site, bad reactions to shingles vaccine and purpura spots on forearms/couple on knees/pupura bleeding.  In April 2022, the patient experienced felt sick, unable to eat and lower abdominal pain.  In April 2022, the felt sick, unable to eat and lower abdominal pain resolved.  On 21 June 2022, the patient experienced bumped a door Knob and had quater inch of spot bleeding on skin.  Shingrix (varicella zoster vaccine rge (cho)), methotrexate and otezla (apremilast) were also considered suspect. The reporter's causality for the event(s) feeling sick, unable to eat, lower abdominal pain, kidney stones, skin bleeding, injection site warmth, injection site itching, injection site redness and haemorrhage purpuric with Humira 40mg/0.8ml(Adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of fatigue with humira 40mg/0.8ml(adalimumab) was no reasonable possibility.  The reporter's causality for the event(s) of kidney stones and accidental injury was not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR103125:same report, 1st dose