Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms, Musculoskeletal stiffness, Nausea, Off label use, Product administered to patient of inappropriate age
Clinical narrative: feeling unwell; Back stiffness/LOWER BACK FELT STIFF AND SORE; Sweating; ARTHRITIS WORSENED; LOWER BACK FELT STIFF AND SORE; Nauseated; Flu like symptoms; Off label dosing frequency; inappropriate age at vaccine administration/ patient below 50 years; appetite lost; Constipation; Cramps; Abdominal Pain; Diarreha; frequent bowel movements; defecation urgency; Blood in stool; vaccination adverse reaction; Difficulty sleeping; Feeling anxious; Feeling Sad; Sick; Activities of daily living impaired/NOT DOLE TO DO THINGS THAT PEERS COULD DO; COVID-19; Sinusitis recurrent; This case was reported by a consumer via other manufacturer and described the occurrence of blood in stool in a 43-year-old male patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included adalimumab (Humira) solution for injection in pre-filled pen (batch number 1143015, expiry date unknown) for ulcerative colitis.   The subject's past medical history included swelling of knees (had swollen knee), movements reduced (had movement issue), joint pain, hot feeling generalized (got hot), facial flushing (face got flushed lots of times), shingles (had shingles in 2015) and dizziness. Concurrent medical conditions included arthritis and ulcerative colitis (Ulcerative colitis without complications).   On an unknown date, the patient received Hz/su + AS01B. On 10th May 2021, the patient started Humira (subcutaneous) 160 mg at an unknown frequency. On 24th May 2021, the dose was changed to 160 mg at an unknown frequency. On an unknown date, the dose was changed to 40 mg at an unknown frequency. On an unknown date, the dose was changed to 40 mg at an unknown frequency. In September 2021, unknown after receiving Hz/su + AS01B, the patient experienced covid-19 and sinusitis recurrent. In October 2021, the patient experienced vaccination adverse reaction, difficulty sleeping, feeling anxious, feeling sad, sickness and activities of daily living impaired. In November 2021, the patient experienced blood in stool (serious criteria GSK medically significant), frequent bowel movements, defecation urgency, cramp, abdominal pain and diarrhea. In February 2022, the patient experienced appetite lost and constipation. On an unknown date, the patient experienced feeling unwell, stiff back, sweating, arthritis aggravated, back pain, nausea, influenza-like symptoms, off label dosing frequency and inappropriate age at vaccine administration. The action taken with Humira was unknown. On an unknown date, the outcome of the covid-19, vaccination adverse reaction, sickness, activities of daily living impaired, blood in stool, frequent bowel movements, defecation urgency, diarrhea, stiff back, sweating, arthritis aggravated, back pain, influenza-like symptoms, off label dosing frequency and inappropriate age at vaccine administration were unknown and the outcome of the sinusitis recurrent, difficulty sleeping, feeling anxious, feeling sad, cramp, abdominal pain, appetite lost, constipation, feeling unwell and nausea were not recovered/not resolved.   It was not reported if the reporter considered the blood in stool, vaccination adverse reaction, frequent bowel movements, defecation urgency, appetite lost, constipation, stiff back, difficulty sleeping, feeling anxious, feeling sad, sweating, arthritis aggravated, back pain, nausea, influenza-like symptoms, covid-19, sinusitis recurrent, cramp, abdominal pain, diarrhea and activities of daily living impaired to be related to Hz/su + AS01B. The reporter considered the feeling unwell and sickness to be related to Hz/su + AS01B.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. In 2021, the patient started Humira 40 mg/0.4 ml (subcutaneous) (40 mg,1 in 10 D) and (40 mg,1 in 7 D). The patient was sick and feeling unwell from shingles vaccine,  on an unknown date, less than 2 years after starting of Humira, the patient experienced arthritis worsened.  In 2021, less than a year after starting of Humira, the patient experienced not feeling well, off label maintenance frequency, lower back felt stiff and sore, sweats and felt nauseated and as if the patient had the flu. Less than 9 months after starting of Humira, the patient experienced Covid and recurring sinus infection.  Less than a year after starting of Humira, the patient experienced sick from Shingles vaccine, not dole to do things that peers could do, trouble sleeping, felt anxious and feeling sad.  Less than a year after starting of Humira, the patient experienced bowel movements were more frequent than usual, had an intense need to have a bowel movement, difficulty sleeping, passes blood in stool, cramping, abdominal pain and diarrhea.  On 28th January 2022, the patient experienced not feeling well.  Between 1 and 2 years after starting of Humira, the patient experienced loss of appetite and constipated. Action taken with Humira 40 mg/0.4 ml for feeling unwell was dose not changed and for Covid-19 and sinusitis recurrent was drug discontinued. It was unknown if the reporter considered the sickness to be related to Humira. The reporter's causality for the events of blood in stool, vaccination adverse reaction, activities of daily living impaired, frequent bowel movements, defecation urgency, off label dosing frequency, appetite lost, constipation, stiff back, difficulty sleeping, feeling anxious, feeling sad, sweating, arthritis aggravated, back pain, nausea, influenza-like symptoms, covid-19, sinusitis recurrent, cramp, abdominal pain and diarrhea and feeling unwell with Humira 40 mg/0.4 ml and Humira 80 mg/0.8 ml was not reported. Follow up would not be possible as no contact details were provided. Note: The event off label dosing frequency was conservatively captured as it was not clear it was related to Shingrix or Humira or both.