Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant, Off label use
Clinical narrative: has since had chemotherapy; Off label dosing frequency; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (has since had chemotherapy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, the patient experienced OFF LABEL USE (Off label dosing frequency). On an unknown date, the patient experienced NEOPLASM MALIGNANT (has since had chemotherapy) (seriousness criterion medically significant). On 21-Jan-2022, OFF LABEL USE (Off label dosing frequency) had resolved. At the time of the report, NEOPLASM MALIGNANT (has since had chemotherapy) outcome was unknown.            Concomitant medication was not reported. Patient received 2 doses of the vaccine and He had since chemotherapy under the direction of his gynecologist. He received an additional primary dose. He was recommended by his HCPs to completely restart the vaccination series a period after completing chemotherapy.  Company Comment: This spontaneous case concerns a male patient with unknown age with history of Cancer ( unknown type and location ) with history of chemotherapy date of treatment and drugs used not reported , who experienced Serious , unexpected event of Neoplasm malignant and non-serious , unexpected event of LLT  off label dosing frequency , PT Off label use  which occurred on an unknown date after vaccination with the 3rd dose of mRNA-1273 vaccine. This patient has already received his primary series vaccine using mRNA-1273 vaccine for two doses  and this Jan 21, 2022 received another primary dose as reported  ,  it was stated  that the HCP  instructed this patient to receive another two doses after the chemotherapy.   Per Guidance in patients who are considered immunocompromised e.g.  Post transplant patients , patients with Cancer and  undergoing chemotherapy , CKD patient and among others with possible depressed immune system as deemed by the HCP a third dose ( full dose )  after 1 month after the 2nd dose can be given  and can be followed by the 1/2 booster dose after 6 months , but  no recommendation as re-starting the primary series. The re-challenge for this case is not applicable . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient with unknown age with history of Cancer ( unknown type and location ) with history of chemotherapy date of treatment and drugs used not reported , who experienced Serious , unexpected event of Neoplasm malignant and non-serious , unexpected event of LLT  off label dosing frequency , PT Off label use  which occurred on an unknown date after vaccination with the 3rd dose of mRNA-1273 vaccine. This patient has already received his primary series vaccine using mRNA-1273 vaccine for two doses  and this Jan 21, 2022 received another primary dose as reported  ,  it was stated  that the HCP  instructed this patient to receive another two doses after the chemotherapy.   Per Guidance in patients who are considered immunocompromised e.g.  Post transplant patients , patients with Cancer and  undergoing chemotherapy , CKD patient and among others with possible depressed immune system as deemed by the HCP a third dose ( full dose )  after 1 month after the 2nd dose can be given  and can be followed by the 1/2 booster dose after 6 months , but  no recommendation as re-starting the primary series. The re-challenge for this case is not applicable . The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report