Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Dysuria, Electromyogram, Magnetic resonance imaging, Muscular weakness
Clinical narrative: STELARA WASN'T REALLY WORKING; DEPRESSION; ADVERSE EFFECTS HAVE INCREASED/GOTTEN WORSE; SUN DAMAGE TO ARMS; RASH, LITTLE RED DOTS/PINPRICKS THAT ITCH; RASH PAINFUL ON HIS BACK, SIDE, ARMS, NECK, BACK, WAIST AND ABDOMEN; MUSCLE ACHES; NUMBNESS/TINGLING IN FEET; WEAKNESS; LOSS OF MUSCLE FUNCTION; DIFFICULTY URINATING; BAD APPETITE; SHAKES; This spontaneous report received from a consumer concerned a 59 year old male. The patient's weight was 170 pounds, and height was 71 inches. The patient had no known allergies. The patient was on ustekinumab (Stelara) (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: 24-AUG-2021) dose was not reported, 1 total administered to left arm on 20-MAR-2021 for prophylactic vaccination.(Dose number in series 1). On an unspecified date in MAR-2021, soon after vaccination (summer), the patient experienced difficulty urinating, bad appetite, shakes, loss of muscle function, muscle aches, numbness/tingling in feet and weakness. The patient had visited the physician's office for difficulty urinating, loss of muscle function, bad appetite and shakes. On an unspecified date, the patient stopped the administration of stelara because it wasn't really working (coded as lack of drug effect) per reporter. The patient experienced rash more recently, little red dots/pinpricks that itch, and rash painful on his back, side, arms, neck, back, waist and abdomen. The adverse effects have increased/ gotten worse as time went on, as result the patient was getting depressed over it. The patient went to urologist, neurologist, dermatologist who diagnosed sun damage to arms and to the rheumatology sun damage to arms, rash, little red dots/pinpricks that itch, and rash painful on his back, side, arms, neck, back, waist and abdomen. Laboratory data (dates unspecified) included: CT (computed tomography) scan (NR: not provided) not reported, Electromyogram (EMG) (NR: not provided) not reported, and Magnetic resonance imaging (MRI) (NR: not provided) not reported.(Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with ustekinumab (Stelara) was withdrawn. The patient had not recovered from difficulty urinating, loss of muscle function, bad appetite, shakes, rash, little red dots/pinpricks that itch, numbness/tingling in feet, weakness, muscle aches, rash painful on his back, side, arms, neck, back, waist and abdomen, and adverse effects have increased/gotten worse, and the outcome of depression, stelara wasn't really working and sun damage to arms was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211238107- covid-19 vaccine ad26.cov2.s stelara wasn't really working. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: Special situation; CONMEDS-OTHER SUSPECT DRUGS  20211238107-ustekinumab  stelara wasn't really working. This event(s) is labeled by standard procedures. The event(s) is considered not related.