Sex: F
Vaccine: COVID19
Symptoms: Illness, Lymphoma, Osteoarthritis, Surgery
Clinical narrative: TUMOR FROM BACK; OSTEOARTHRITIS IN HANDS/FEET; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (TUMOR FROM BACK) in an adult 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) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced LYMPHOMA (TUMOR FROM BACK) (seriousness criterion medically significant), OSTEOARTHRITIS (OSTEOARTHRITIS IN HANDS/FEET) and ILLNESS (Sickness). The patient was treated with Surgery for Lymphoma. At the time of the report, LYMPHOMA (TUMOR FROM BACK), OSTEOARTHRITIS (OSTEOARTHRITIS IN HANDS/FEET) and ILLNESS (Sickness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Surgery: tumor from back was removed and it is consistent to lymphoma.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.  No concomitant medications were reported. It was unknown if the patient was enrolled in a COVID-19 Vaccine Trial. Patient was sick after second COVID vaccine. No treatment medications were reported.  Company comment. This spontaneous case concerns an adult female patient, with relevant medical history of Rheumatoid arthritis, who received two doses of mRNA-1273 vaccine and experienced the serious medically significant unexpected event of lymphoma. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The patient had surgery to remove a tumor from her back which was consistent with lymphoma. No further clinical information regarding the event have been provided for medical reviewing. Patient´s mentioned medical history and Co-suspect product Adalimumab could be risk factors for lymphoma. The benefit risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2022: Non-Significant follow-up appended; Sender's Comments: This spontaneous case concerns an adult female patient, with relevant medical history of Rheumatoid arthritis, who received two doses of mRNA-1273 vaccine and experienced the serious medically significant unexpected event of lymphoma. Vaccination date and onset date of the event were not reported; hence latency and temporal association cannot be properly assessed. The patient had surgery to remove a tumor from her back which was consistent with lymphoma. No further clinical information regarding the event have been provided for medical reviewing. Patient´s mentioned medical history and Co-suspect product Adalimumab could be risk factors for lymphoma. The benefit risk relationship of mRNA-1273 is not affected by this report.