Age: 67.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19 virus test positive) in a 67-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect products included non-company products IBRUTINIB (IMBRUVICA) tablet for B-cell chronic lymphocytic leukaemia and COVID-19 VACCINE for COVID-19 vaccination.    No Medical History information was reported.   On 01-Sep-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and dose of COVID-19 VACCINE (Intramuscular) 1 dosage form. On 07-Jun-2022, the patient experienced COVID-19 (COVID-19 virus test positive). The patient was treated with MOLNUPIRAVIR at an unspecified dose and frequency. In June 2022, COVID-19 (COVID-19 virus test positive) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       The patient has other concomitant therapy of antivirals (unspecified).  In Jun-2022, the patient experienced nasal congestion. On 07-Jun-2022, the patient experienced sinus congestion and fatigue . It was reported that, the nasal congestion was recovering, sinus congestion and fatigue was resolved on unspecified date of Jun-2022.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of COVID-19 positive, nasal congestion, sinus congestion and fatigue against suspect drug ibrutinib was not provided and reported as possibly related against suspect COVID-19 vaccine.  Company comment:  This spontaneous case concerns a 67-year-old male patient, with no reported medical history, on Ibrutinib for chronic lymphocytic leukemia of B-cell type not having achieved remission, who experienced the unexpected non-serious AESI COVID-19 after receiving the dose of mRNA-1273 vaccine on an unknown date. Patient reported nasal congestion and fatigue, and positive SARS-CoV-2 test. Patient took Molnupiravir as a treatment drug. The outcome of event was reported as resolved. Patient received booster dose of COVID-19 vaccine (product name and date not reported). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed as non-serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 67-year-old male patient, with no reported medical history, on Ibrutinib for chronic lymphocytic leukemia of B-cell type not having achieved remission, who experienced the unexpected non-serious AESI COVID-19 after receiving the dose of mRNA-1273 vaccine on an unknown date. Patient reported nasal congestion and fatigue, and positive SARS-CoV-2 test. Patient took Molnupiravir as a treatment drug. The outcome of event was reported as resolved. Patient received booster dose of COVID-19 vaccine (product name and date not reported). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed as non-serious based on medical judgement.