Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Metastasis, Neoplasm malignant, Tinnitus
Clinical narrative: Tinnitus after each dose/even longer with booster/tinnitus got louder and worse with each dose/tinnitus in both ears/It was bad; diagnosed with cancer that has metastasized to other organs with unknown origination.; diagnosed with cancer that has metastasized to other organs with unknown origination.; This spontaneous case was reported by a patient and describes the occurrence of NEOPLASM MALIGNANT (diagnosed with cancer that has metastasized to other organs with unknown origination.) and METASTASIS (diagnosed with cancer that has metastasized to other organs with unknown origination.) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (breaks into a pink rash). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, the patient experienced NEOPLASM MALIGNANT (diagnosed with cancer that has metastasized to other organs with unknown origination.) (seriousness criterion medically significant) and METASTASIS (diagnosed with cancer that has metastasized to other organs with unknown origination.) (seriousness criterion medically significant). On an unknown date, the patient experienced TINNITUS (Tinnitus after each dose/even longer with booster/tinnitus got louder and worse with each dose/tinnitus in both ears/It was bad). At the time of the report, NEOPLASM MALIGNANT (diagnosed with cancer that has metastasized to other organs with unknown origination.), METASTASIS (diagnosed with cancer that has metastasized to other organs with unknown origination.) and TINNITUS (Tinnitus after each dose/even longer with booster/tinnitus got louder and worse with each dose/tinnitus in both ears/It was bad) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2022, Computerised tomogram: hardening of organs.         In medical history it was reported that patient was healthy until cancer. Patient had the following labs: CA 125, CEA Blood Level, and CA19-9. Patient was consulting Acupuncturist for tinnitus and Oncologist for cancer. No treatment medication was reported.  Company Comment:  This is a spontaneous case concerning a 79-year-old female patient with concomitant medication of Aspirin, who experienced the unexpected serious (medically significant) events of Neoplasm malignant with Metastasis, reported as cancer that has metastasized to other organs with unknown origin, which occurred approximately 8 months and 3 weeks after receiving a dose of mRNA-1273 as the third/booster dose of COVID-19 vaccine. Patient had received the first dose of mRNA-1273 vaccine and unspecified COVID-19 vaccine prior to booster dose of mRNA-1273 vaccine. It was reported that the patient also experienced loud tinnitus in both ears after each dose that persisted for 3 to 4 months, which became louder, worse, and longer in duration after each dose. Patient consulted an Acupuncturist for tinnitus and Oncologist for cancer. Patient had CA 125, CEA Blood Level, and CA19-9 tumor markers, however, no results were reported. Patient also underwent Computerised tomogram which showed "hardening of organs" and was scheduled for a biopsy. No further details about the treatments were provided. It was reported that patient still had residual effects of tinnitus and ongoing cancer. The concomitant intake of Aspirin remains as a confounder for the event Tinnitus. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-613185 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 79-year-old female patient with concomitant medication of Aspirin, who experienced the unexpected serious (medically significant) events of Neoplasm malignant with Metastasis, reported as cancer that has metastasized to other organs with unknown origin, which occurred approximately 8 months and 3 weeks after receiving a dose of mRNA-1273 as the third/booster dose of COVID-19 vaccine. Patient had received the first dose of mRNA-1273 vaccine and unspecified COVID-19 vaccine prior to booster dose of mRNA-1273 vaccine. It was reported that the patient also experienced loud tinnitus in both ears after each dose that persisted for 3 to 4 months, which became louder, worse, and longer in duration after each dose. Patient consulted an Acupuncturist for tinnitus and Oncologist for cancer. Patient had CA 125, CEA Blood Level, and CA19-9 tumor markers, however, no results were reported. Patient also underwent Computerised tomogram which showed "hardening of organs" and was scheduled for a biopsy. No further details about the treatments were provided. It was reported that patient still had residual effects of tinnitus and ongoing cancer. The concomitant intake of Aspirin remains as a confounder for the event Tinnitus. The benefit-risk relationship of mRNA-1273 is not affected by this report.