Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Constipation, Hiccups, Incorrect route of product administration, Joint range of motion decreased, Ligament rupture
Clinical narrative: Prostate cancer; Tooth infection / INFECTION IN MOLAR; Joint ligament rupture / TORN LIGAMENTS IN LEFT WRIST; Hiccups; Intramuscular formulation administered by other route / COVID BOOSTER INJECTION HIT BURSA/SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION/ MAKING SHOULDER PAINFUL; Shoulder injury related to vaccine administration / COVID BOOSTER INJECTION HIT BURSA/SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION/ MAKING SHOULDER PAINFUL; Joint range of motion decreased / COULD NOT LIFT ARM ABOVE HEAD with HUMIRA (ADALIMUMAB); Vaccination site pain / MAKING SHOULDER PAINFUL; Constipation; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATE CANCER (Prostate cancer) in a 63-year-old 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 ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis and CORTISONE for an unknown indication.    Concurrent medical conditions included Ulcerative colitis (Moderate to Severe).   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen and CORTISONE (unknown route) at an unspecified dose. In 2021, the patient experienced CONSTIPATION (Constipation). In September 2021, the patient experienced JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased / COULD NOT LIFT ARM ABOVE HEAD with HUMIRA (ADALIMUMAB)), VACCINATION SITE PAIN (Vaccination site pain / MAKING SHOULDER PAINFUL), SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Shoulder injury related to vaccine administration / COVID BOOSTER INJECTION HIT BURSA/SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION/ MAKING SHOULDER PAINFUL) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intramuscular formulation administered by other route / COVID BOOSTER INJECTION HIT BURSA/SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION/ MAKING SHOULDER PAINFUL). On an unknown date, the patient experienced PROSTATE CANCER (Prostate cancer) (seriousness criterion medically significant), TOOTH INFECTION (Tooth infection / INFECTION IN MOLAR), LIGAMENT RUPTURE (Joint ligament rupture / TORN LIGAMENTS IN LEFT WRIST) and HICCUPS (Hiccups). At the time of the report, PROSTATE CANCER (Prostate cancer) had resolved, JOINT RANGE OF MOTION DECREASED (Joint range of motion decreased / COULD NOT LIFT ARM ABOVE HEAD with HUMIRA (ADALIMUMAB)), TOOTH INFECTION (Tooth infection / INFECTION IN MOLAR) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Intramuscular formulation administered by other route / COVID BOOSTER INJECTION HIT BURSA/SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION/ MAKING SHOULDER PAINFUL) outcome was unknown and VACCINATION SITE PAIN (Vaccination site pain / MAKING SHOULDER PAINFUL), CONSTIPATION (Constipation), LIGAMENT RUPTURE (Joint ligament rupture / TORN LIGAMENTS IN LEFT WRIST), SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION (Shoulder injury related to vaccine administration / COVID BOOSTER INJECTION HIT BURSA/SHOULDER INJURY RELATED TO VACCINE ADMINISTRATION/ MAKING SHOULDER PAINFUL) and HICCUPS (Hiccups) had not resolved.            Company comment: This is a spontaneous case concerning a 63-year-old male patient with Ulcerative colitis on treatment with Adalimumab and cortisone, who experienced the serious (medically significant) unexpected event prostate cancer, on an unknown date after vaccination with mRNA-1273.  It was reported that cancer had been removed. Additional clinical findings, diagnostic tests and treatment details were not provided. Adalimumab and cortisone was reported as a co-suspect product. Incorrect route of product administration, shoulder injury related to vaccine administration, vaccination site pain and joint range of motion decreased were also reported as non-serious events. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant medications were provided by the reporter. The patient received HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB). It was unknown if he was enrolled in a COVID-19 Vaccine Trial. The patient had prostate cancer which was removed. He had torn ligaments in his left wrist. He had taken cortisone for the issue that caused hiccups. He had been taking antibiotics for an infection in molar. n Sep 2021, he received booster dose COVID-19 Vaccine manufactured by Moderna and since Sep-2021, patient experienced shoulder injury related to vaccine administration, a reaction to an injection that hit his bursa which caused shoulder pain and he could not lift his arm above his head. The reporter's causality for the event(s) of prostate cancer, constipation, torn ligaments in left wrist, infection in molar, covid booster injection hit bursa/shoulder injury related to vaccine administration/ making shoulder painful onset in September 2021, covid booster injection hit bursa/shoulder injury related to vaccine administration/ making shoulder painful onset in September 2021, hiccups and could not lift arm above head was not provided.  The reporter's causality for the event   Reporter did not allow further contact.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.; Sender's Comments: Company comment: This is a spontaneous case concerning a 63-year-old male patient with Ulcerative colitis on treatment with Adalimumab and cortisone, who experienced the serious (medically significant) unexpected event prostate cancer, on an unknown date after vaccination with mRNA-1273.  It was reported that cancer had been removed. Additional clinical findings, diagnostic tests and treatment details were not provided. Adalimumab and cortisone was reported as a co-suspect product. Incorrect route of product administration, shoulder injury related to vaccine administration, vaccination site pain and joint range of motion decreased were also reported as non-serious events. Events seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.