Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Decreased appetite, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: Clot blood; Weakness; Cough; Heaviness in leg; Back pain; Mouth pain; Difficulty in walking; Mood altered; Breathing difficult; felt tired after covid vaccine; Lower extremities discomfort; Abdominal pain lower; Unable to walk; Decreased appetite; Tiredness; Colorectal cancer; This spontaneous case was reported by a consumer and describes the occurrence of COLORECTAL CANCER (Colorectal cancer) and THROMBOSIS (Clot blood) in a 64-year-old female 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 product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second 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) UNK, Citrate Free. In 2021, the patient experienced COLORECTAL CANCER (Colorectal cancer) (seriousness criterion medically significant) and FATIGUE (Tiredness). In July 2021, the patient experienced GAIT INABILITY (Unable to walk), DECREASED APPETITE (Decreased appetite), LIMB DISCOMFORT (Lower extremities discomfort), ABDOMINAL PAIN LOWER (Abdominal pain lower) and FATIGUE (felt tired after covid vaccine). On an unknown date, the patient experienced THROMBOSIS (Clot blood) (seriousness criterion medically significant), ASTHENIA (Weakness), COUGH (Cough), LIMB DISCOMFORT (Heaviness in leg), BACK PAIN (Back pain), ORAL PAIN (Mouth pain), GAIT DISTURBANCE (Difficulty in walking), MOOD ALTERED (Mood altered) and DYSPNOEA (Breathing difficult). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Nausea, at an unspecified dose and frequency; DICYCLOMINE [DICYCLOVERINE] for Pain stomach, at an unspecified dose and frequency; ONDANSETRON for Nausea, at an unspecified dose and frequency and APIXABAN (ELIQUIS) for Thrombosis, at an unspecified dose and frequency. In 2021, COLORECTAL CANCER (Colorectal cancer) and FATIGUE (Tiredness) had resolved. At the time of the report, THROMBOSIS (Clot blood), ASTHENIA (Weakness), COUGH (Cough), LIMB DISCOMFORT (Heaviness in leg), BACK PAIN (Back pain) and ORAL PAIN (Mouth pain) had not resolved and GAIT INABILITY (Unable to walk), DECREASED APPETITE (Decreased appetite), GAIT DISTURBANCE (Difficulty in walking), MOOD ALTERED (Mood altered), LIMB DISCOMFORT (Lower extremities discomfort), ABDOMINAL PAIN LOWER (Abdominal pain lower), DYSPNOEA (Breathing difficult) and FATIGUE (felt tired after covid vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: Possible colorectal cancer. In 2021, Weight: Losing. On an unknown date, Computerised tomogram: Possible colorectal cancer.         Concomitant medications details were not reported.  Patient had been tired and moody. Patient had not had an appetite lately. Patient's legs felt like lead balloons. Patient had a cough and was put on a medication to help. Patient had back pain. Patient also had not had an appetite in 2021 and had been feeling nauseous and as a result loosen weight so was put on Dicyclomine to relax the muscles in colon and Ondansetron to help with nausea and each medication caused patient to felt tired. Patient had a cough that would not go away and also had a stricture. Patient had trouble breathing and found that was caused by a blood clot.  Patient's mouth hurts when patient eats. Patient was having trouble walking.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Jul 2021 Patient noticed something felt odd after second Moderna vaccine.  The reporter's causality for the events of Colorectal cancer, Appetite lost (episode 1), Tiredness, Asthenia, Cough, Thrombosis, Nausea, Unevaluable event, heaviness in leg, Stomach pain, Back pain, Mouth pain was reported as No reasonable possibility to Humira and for the events  Weight decreased, Gait disturbance, Decreased appetite (episode 2), Mood altered, breathing difficult, abdominal pain lower, lower extremities discomfort was not reported.  Decreased appetite, weight loss, nausea, Tiredness and stomach pain were subsumed under the diagnosis of Colorectal cancer.  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.  This spontaneous case concerns a 64-year-old female patient with concurrent Crohn's disease, who experienced the unexpected, serious  (medically significant) event of Colorectal cancer, and adverse event of special interest Thrombosis (Clot blood) on unknown dates in the context of receiving mRNA-1273 vaccine.  Onset latency could not be determined as exact dates of vaccination and onset of events were not reported. Patient presented with stomach pain, nausea, decreased appetite, weight loss and tiredness for which Ondansetron and Dicyclomine were given as treatment. A Computerized tomogram done showed findings of possible colorectal cancer. Apixaban (Eliquis) was given for a blood clot that had caused difficult breathing.  Two doses of mRNA-1273 vaccine were received on unknown dates and interval. The concurrent Crohn's disease  remains a confounder for the event Colorectal cancer. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 64-year-old female patient with concurrent Crohn's disease, who experienced the unexpected, serious  (medically significant) event of Colorectal cancer, and adverse event of special interest Thrombosis (Clot blood) on unknown dates in the context of receiving mRNA-1273 vaccine.  Onset latency could not be determined as exact dates of vaccination and onset of events were not reported. Patient presented with stomach pain, nausea, decreased appetite, weight loss and tiredness for which Ondansetron and Dicyclomine were given as treatment. A Computerized tomogram done showed findings of possible colorectal cancer. Apixaban (Eliquis) was given for a blood clot that had caused difficult breathing.  Two doses of mRNA-1273 vaccine were received on unknown dates and interval. The concurrent Crohn's disease  remains a confounder for the event Colorectal cancer. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.