Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disturbance in attention, Feeling abnormal, Headache, SARS-CoV-2 antibody test
Clinical narrative: Head felt foggy; Not focused right; Headache; COVID-19; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Head felt foggy), DISTURBANCE IN ATTENTION (Not focused right) and HEADACHE (Headache) in a 65-year-old 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 IBRUTINIB (IMBRUVICA) for Small cell lymphocytic lymphoma and Chronic lymphoid leukemia.    No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. In January 2022, the patient experienced the first episode of COVID-19 (COVID-19). In 2022, the patient experienced the second episode of COVID-19 (COVID-19). In August 2022, the patient experienced FEELING ABNORMAL (Head felt foggy) (seriousness criterion hospitalization), DISTURBANCE IN ATTENTION (Not focused right) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). At the time of the report, FEELING ABNORMAL (Head felt foggy), DISTURBANCE IN ATTENTION (Not focused right) and HEADACHE (Headache) was resolving and last episode of COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: Positive. In 2022, SARS-CoV-2 test: Positive. On an unknown date, SARS-CoV-2 antibody test: Patient does not have antibodies for covid-19. On an unknown date, White blood cell count: Low.         Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  In Aug 2022, the patient head felt foggy, not focused right and headache and she was hospitalized due to it. Physician not sure what it was. Patient advised her white blood cells were really down. She was positive for COVID in eight months.  Treatment information was not provided. Company Comment :This spontaneous case concerns a 65-year-old, female patient with history of co-suspect intake of Imbruvica (ibrutinib) for Small cell lymphocytic lymphoma and Chronic lymphoid leukemia, who experienced the unexpected, serious (hospitalization) events of feeling abnormal (foggy feeling in head), disturbance in attention and headache, and the unexpected, non-serious events of COVID-19 (two events). The event COVID-19 (first event) occurred unknown number of days after intake of Imbruvica and unknown number of days after receiving the third dose of the mRNA-1273 original vaccine. Of note, the dates of intake of Imbruvica was not provided and the event onset date was reported as unspecified date in Jan2022, hence, the onset latency could not be assessed. The event COVID-19 (second event) occurred unknown number of days after intake of Imbruvica and unknown number of days after receiving the third dose of the mRNA-1273 original vaccine. Of note, the event onset date was reported as unspecified date in 2022, hence, the onset latency could not be assessed. No COVID-19 symptoms were reported. In both events, the patient tested positive for SARS-CoV-2 and it was reported that the patient was positive for COVID-19 in 8 months. On an unspecified date, the Antibody test showed that the patient does not have antibodies for COVID-19. Treatment information was not provided. On an unspecified date in 2022, the event COVID-19  had resolved. The events feeling abnormal, disturbance in attention and headache occurred unknown number of days after intake of Imbruvica and unknown number of days after receiving the third dose of the mRNA-1273 original vaccine. Of note, the event onset dates were reported as unspecified dates in Aug2022, hence, the onset latency could not be assessed. It was reported that the patient's head felt foggy, not focused right, and she also had headache. The patient was hospitalized due to these events. It was reported that the patient's white blood cells were 'really down' (values were not provided) and that the physician was not sure what it was. No further clinical information (including details about hospitalization, other diagnostic test/s and treatment) was available for medical review. However, the events were resolving at the time of the report. The co-suspect intake of Imbruvica remains a confounder for the event headache which is a common side effect of the medication. The medical history of Small cell lymphocytic lymphoma and Chronic lymphoid leukemia on antineoplastic therapy with Imbruvica (immunocompromised state) and the patient's advanced age (high risk for infections) remain as confounders for the events COVID-19. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report. ; Sender's Comments: This spontaneous case concerns a 65-year-old, female patient with history of co-suspect intake of Imbruvica (ibrutinib) for Small cell lymphocytic lymphoma and Chronic lymphoid leukemia, who experienced the unexpected, serious (hospitalization) events of feeling abnormal (foggy feeling in head), disturbance in attention and headache, and the unexpected, non-serious events of COVID-19 (two events). The event COVID-19 (first event) occurred unknown number of days after intake of Imbruvica and unknown number of days after receiving the third dose of the mRNA-1273 original vaccine. Of note, the dates of intake of Imbruvica was not provided and the event onset date was reported as unspecified date in Jan2022, hence, the onset latency could not be assessed. The event COVID-19 (second event) occurred unknown number of days after intake of Imbruvica and unknown number of days after receiving the third dose of the mRNA-1273 original vaccine. Of note, the event onset date was reported as unspecified date in 2022, hence, the onset latency could not be assessed. No COVID-19 symptoms were reported. In both events, the patient tested positive for SARS-CoV-2 and it was reported that the patient was positive for COVID-19 in 8 months. On an unspecified date, the Antibody test showed that the patient does not have antibodies for COVID-19. Treatment information was not provided. On an unspecified date in 2022, the event COVID-19  had resolved. The events feeling abnormal, disturbance in attention and headache occurred unknown number of days after intake of Imbruvica and unknown number of days after receiving the third dose of the mRNA-1273 original vaccine. Of note, the event onset dates were reported as unspecified dates in Aug2022, hence, the onset latency could not be assessed. It was reported that the patient's head felt foggy, not focused right, and she also had headache. The patient was hospitalized due to these events. It was reported that the patient's white blood cells were 'really down' (values were not provided) and that the physician was not sure what it was. No further clinical information (including details about hospitalization, other diagnostic test/s and treatment) was available for medical review. However, the events were resolving at the time of the report. The co-suspect intake of Imbruvica remains a confounder for the event headache which is a common side effect of the medication. The medical history of Small cell lymphocytic lymphoma and Chronic lymphoid leukemia on antineoplastic therapy with Imbruvica (immunocompromised state) and the patient's advanced age (high risk for infections) remain as confounders for the events COVID-19. The benefit-risk relationship of the mRNA-1273 original vaccine is not affected by this report.