Reporte zur Charge 1013L20A

Symptomtext

Cancer of colon; Hard of hearing; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of COLON CANCER (Cancer of colon) and HYPOACUSIS (Hard of hearing) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 1013L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLON CANCER (Cancer of colon) (seriousness criteria hospitalization and medically significant) and HYPOACUSIS (Hard of hearing) (seriousness criterion hospitalization). The patient was treated with Surgery (40% of colon removed.) for Colon cancer. At the time of the report, COLON CANCER (Cancer of colon) and HYPOACUSIS (Hard of hearing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: found a mass that looks suspicious (abnormal) found a mass that looks suspicious. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Patient was scheduled for a booster shot. patient was finished 8th round of chemotherapy out of 8 and that he was immunocompromised. Patient stated he had no side effects from either dose. Patient had surgery and 40% of his colon removed, patient also was on chemotherapy. This case concerns a 72-year-old, male patient with no relevant medical history, who experienced the unexpected event Colon cancer. The event occurred after the second dose of Spikevax but the exact date was not reported. The rechallenge was negative. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns a 72-year-old, male patient with no relevant medical history, who experienced the unexpected event Colon cancer. The event occurred after the second dose of Spikevax but the exact date was not reported. The rechallenge was negative. The benefit-risk relationship of Spikevax in not affected by this report.