Sex: M
Vaccine: COVID19
Symptoms: Gout, Haemoglobin, Hypertension, Muscle spasms, Pain
Clinical narrative: Bruising; ZITS / PIMPLES AROUND BODY, FACE, LIP, LEGS THAT TRAVEL AROUND AND PAINFUL; GOUT IN BIG TOES; TINNITUS; HAND CRAMPS; ZITS / PIMPLES AROUND BODY, FACE, LIP, LEGS THAT TRAVEL AROUND AND PAINFUL; PAINFUL TOES; RED MARKS ON FACE AND UPPER LIP/RED TOES; CUTS ON SKIN NEAR FINGER TIPS; Nose bleed; HIGH BLOOD PRESSURE; MUSCULOSKELETAL RIGHT THIGH PAIN; FELT LOUSY; Diarrhea; HIP PAIN; HIP PAIN; Leg pain; DRY CRACKING SKIN ON FINGERS; DRY CRACKING SKIN ON FINGERS; This spontaneous case was reported by a consumer and describes the occurrence of SKIN FISSURES (DRY CRACKING SKIN ON FINGERS), DRY SKIN (DRY CRACKING SKIN ON FINGERS), CONTUSION (Bruising), PAIN (ZITS / PIMPLES AROUND BODY, FACE, LIP, LEGS THAT TRAVEL AROUND AND PAINFUL) and GOUT (GOUT IN BIG TOES) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) capsule for B-cell chronic lymphocytic leukemia and IBRUTINIB (IMBRUVICA) tablet for B-cell chronic lymphocytic leukemia.    No Known allergies.  Concurrent medical conditions included B-cell chronic lymphocytic leukemia (CHRONIC LYMPHOCYTIC LEUKEMIA OF B-CELL IN REMISSION). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, BACLOFEN for an unknown indication.   On 22-Nov-2021, the patient IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 420 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day and IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. In 2021, the patient experienced SKIN FISSURES (DRY CRACKING SKIN ON FINGERS), DRY SKIN (DRY CRACKING SKIN ON FINGERS), PAIN IN EXTREMITY (Leg pain), FEELING ABNORMAL (FELT LOUSY), DIARRHOEA (Diarrhea), the first episode of ARTHRALGIA (HIP PAIN) and the second episode of ARTHRALGIA (HIP PAIN). In December 2021, the patient experienced PAIN IN EXTREMITY (MUSCULOSKELETAL RIGHT THIGH PAIN). On an unknown date, the patient experienced CONTUSION (Bruising), PAIN (ZITS / PIMPLES AROUND BODY, FACE, LIP, LEGS THAT TRAVEL AROUND AND PAINFUL), GOUT (GOUT IN BIG TOES), TINNITUS (TINNITUS), MUSCLE SPASMS (HAND CRAMPS), ACNE (ZITS / PIMPLES AROUND BODY, FACE, LIP, LEGS THAT TRAVEL AROUND AND PAINFUL), PAIN IN EXTREMITY (PAINFUL TOES), ERYTHEMA (RED MARKS ON FACE AND UPPER LIP/RED TOES), SKIN LACERATION (CUTS ON SKIN NEAR FINGER TIPS), EPISTAXIS (Nose bleed) and HYPERTENSION (HIGH BLOOD PRESSURE). The patient was treated with COLCHICINE at an unspecified dose and frequency and ALLOPURINOL at an unspecified dose and frequency. On 20-Dec-2021, last episode of ARTHRALGIA (HIP PAIN) had resolved. At the time of the report, SKIN FISSURES (DRY CRACKING SKIN ON FINGERS), DRY SKIN (DRY CRACKING SKIN ON FINGERS), CONTUSION (Bruising), PAIN (ZITS / PIMPLES AROUND BODY, FACE, LIP, LEGS THAT TRAVEL AROUND AND PAINFUL), GOUT (GOUT IN BIG TOES), TINNITUS (TINNITUS), MUSCLE SPASMS (HAND CRAMPS), ACNE (ZITS / PIMPLES AROUND BODY, FACE, LIP, LEGS THAT TRAVEL AROUND AND PAINFUL), PAIN IN EXTREMITY (PAINFUL TOES), PAIN IN EXTREMITY (MUSCULOSKELETAL RIGHT THIGH PAIN) and ERYTHEMA (RED MARKS ON FACE AND UPPER LIP/RED TOES) had not resolved, PAIN IN EXTREMITY (Leg pain), SKIN LACERATION (CUTS ON SKIN NEAR FINGER TIPS) and DIARRHOEA (Diarrhea) was resolving and EPISTAXIS (Nose bleed), HYPERTENSION (HIGH BLOOD PRESSURE) and FEELING ABNORMAL (FELT LOUSY) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement (73-140): high High and high High. On an unknown date, Blood uric acid: 6.4 6.4. On an unknown date, Haemoglobin: low Low. On an unknown date, Platelet count: low Low and 80,000 80,000.         It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Unknown date, patient received booster dose Moderna COVID-19 Vaccine. The patient experienced gout was worsened.  It was reported that the reporter's causality of IMBRUVICA(IBRUTINIB) (22-Nov-2021 - Discontinued) for the event(s) of DRY CRACKING SKIN ON FINGERS onset in 2021, DRY CRACKING SKIN ON FINGERS onset in 2021, CUTS ON SKIN NEAR FINGER TIPS, ZITS / PIMPLES AROUND BODY, FACE, LIP, LEGS THAT TRAVEL AROUND AND PAINFUL unknown onset, GOUT IN BIG TOES, URIC ACID LEVEL SIX POINT FOUR, TINNITUS, ZITS / PIMPLES AROUND BODY, FACE, LIP, LEGS THAT TRAVEL AROUND AND PAINFUL unknown onset, HIP PAIN onset in 2021, BRUISING, DIARRHEA, HAND CRAMPS, MUSCULOSKELETAL RIGHT THIGH PAIN, LOW PLATELETS, PAINFUL TOES, LOW HEMOGLOBIN and RED MARKS ON FACE AND UPPER LIP/RED TOES with IMBRUVICA(IBRUTINIB) was a reasonable possibility. The reporter's causality for the event(s) of FELT LOUSY, LEG PAIN, HIP PAIN onset in 2021, NOSEBLEED and HIGH BLOOD PRESSURE was not provided.  It was reported that the reporter's causality of IMBRUVICA(IBRUTINIB) (unknown - ongoing) the event(s) of DRY CRACKING SKIN ON FINGERS onset in 2021, DRY CRACKING SKIN ON FINGERS onset in 2021, FELT LOUSY, CUTS ON SKIN NEAR FINGER TIPS, ZITS / PIMPLES AROUND BODY, FACE, LIP, LEGS THAT TRAVEL AROUND AND PAINFUL unknown onset, GOUT IN BIG TOES, URIC ACID LEVEL SIX POINT FOUR, TINNITUS, ZITS/ PIMPLES AROUND BODY, FACE, LIP, LEGS THAT TRAVEL AROUND AND PAINFUL unknown onset, HIP PAIN onset in 2021, BRUISING, LEG PAIN, HIP PAIN onset in 2021, DIARRHEA, HAND CRAMPS, NOSE BLEED, MUSCULOSKELETAL RIGHT THIGH PAIN and HIGH BLOOD PRESSURE was not provided. The reporter's causality for the event(s) of LOW PLATELETS, PAINFUL TOES, LOW HEMOGLOBIN and RED MARKS ON FACE AND UPPER LIP/RED TOES with IMBRUVICA(IBRUTINIB) was a reasonable possibility.   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2022: Live follow-up received contains events information added. On 03-Mar-2022: Live follow-up received contains events information updated. On 15-Apr-2022: Live follow-up received contains new events and causality added. On 18-May-2022: Live follow-up received contains lab details, treatment medication information, new events and causality added and narrative description updated.