Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt under the weather after first dose, second dose , first booster dose) and COVID-19 (Tested positive for Covid-19 on 31-Mar-22) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 007B21A and 001A21A) for COVID-19 vaccination. The patient's past medical history included Metastatic melanoma (No recent changes in condition status. He was on immunotherapy to treat Metastatic Melanoma. Otherwise he has been totally Healthy and Cancer is gone.) on 30-Jul-2020 and Brain tumor operation (melanoma brain tumor) in July 2020. Previously administered products included for Metastatic melanoma: IPILIMUMAB;NIVOLUMAB (received 15 months of immunotherapy treatment) from October 2020 to December 2021. Past adverse reactions to the above products included No adverse event with IPILIMUMAB; and NIVOLUMAB. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, the patient experienced MALAISE (Felt under the weather after first dose, second dose , first booster dose). On 31-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Tested positive for Covid-19 on 31-Mar-22). On 09-Nov-2021, MALAISE (Felt under the weather after first dose, second dose , first booster dose) had resolved. At the time of the report, COVID-19 (Tested positive for Covid-19 on 31-Mar-22) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2022, SARS-CoV-2 test: (Positive) Positive. No concomitant medications were reported and patient was not on any medications at the time of vaccinations. It was reported that patient felt under the weather for 1 day after the first booster dose on 08-Nov-2021 and resolved on 09-Nov-2021. No treatment details were reported. Company comment This spontaneous case concerns a male patient aged 66 years, with medical history  of Metastatic melanoma treated with IPILIMUMAB-NIVOLUMAB from October 2020 to December 2021, and Brain melanoma operation in July 2020 who experienced the unexpected RA of Covid-19, and the unexpected event of malaise beginning the same  day of the 3rd. dose of mRNA-1273 vaccine.  Patient test positive for SARS covid-19 approximately 4 months, 20 days after the administration of mRNA-1273 vaccine, used as a booster dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement. This case was linked to MOD-2022-610536, MOD-2022-610541 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2022: The follow up information received contains significant information includes patient information, new event COVID-19 and medical history information were updated. Sender's Comments: This spontaneous case concerns a male patient aged 66 years, with medical history  of Metastatic melanoma treated with IPILIMUMAB-NIVOLUMAB from October 2020 to December 2021, and Brain melanoma operation in July 2020 who experienced the unexpected AESI of Covid-19, and the unexpected event of malaise beginning the same  day of the 3rd. dose of mRNA-1273 vaccine. Patient test positive for SARS covid-19 approximately 4 months, 20 days after the administration of mRNA-1273 vaccine, used as a booster dose  The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.