Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, COVID-19 pneumonia, Coma, Contusion, Depression
Clinical narrative: PNEUMONIA DUE TO COVID/IN COMA WITH COVID; PNEUMONIA DUE TO COVID/IN COMA WITH COVID; Depression; BRUISING POPPED UP; Interchange of vaccine products; Revaccination with different COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 PNEUMONIA (PNEUMONIA DUE TO COVID/IN COMA WITH COVID) and COMA (PNEUMONIA DUE TO COVID/IN COMA WITH COVID) in a 57-year-old male 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) film-coated tablet for Chronic lymphocytic leukemia.    Patient had no known allergies.  The patient's past medical history included Hip surgery in November 2017. Concurrent medical conditions included Abstains from alcohol, Chronic lymphocytic leukaemia, Non-tobacco user, Abstains from recreational drugs and Headache. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, LAMOTRIGINE from 01-Jun-2021 to an unknown date for Headache, VALACYCLOVIR HYDROCHLORIDE from 20-Mar-2021 to an unknown date, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) from 30-Sep-2017 to an unknown date, ESCITALOPRAM OXALATE (LEXAPRO) from 01-Jun-2021 to an unknown date and SULFAMETHIZOLE;TRIMETHOPRIM from 20-Mar-2021 to an unknown date for an unknown indication.   On 01-Mar-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 mg Last admin date- 2021, every 1 days. On 20-Mar-2021, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 240 milligram. In 2021, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 240 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced COVID-19 PNEUMONIA (PNEUMONIA DUE TO COVID/IN COMA WITH COVID) (seriousness criteria hospitalization prolonged and medically significant). On 29-Aug-2021, the patient experienced COMA (PNEUMONIA DUE TO COVID/IN COMA WITH COVID) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced DEPRESSION (Depression), CONTUSION (BRUISING POPPED UP), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). The patient was hospitalized on sometime in August 2021 due to COMA and COVID-19 PNEUMONIA. On 29-Aug-2021, COVID-19 PNEUMONIA (PNEUMONIA DUE TO COVID/IN COMA WITH COVID) had resolved. On 02-Sep-2021, COMA (PNEUMONIA DUE TO COVID/IN COMA WITH COVID) had resolved. At the time of the report, DEPRESSION (Depression), CONTUSION (BRUISING POPPED UP), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.           It was reported that in Aug-2021, the patient had to stop Imbruvica for a week because he had pneumonia due to covid. He was hospitalized and was in a coma for five days with covid.   The reporter's causality for the event(s) of Side effects/moderna booster that mad patient not feel well with Moderna COVID-19 vaccine (Elasomeran) was reasonable possibility.  The reporter's causality for the events of Pneumonia due to covid/in coma with covid/tested positive for COVID-19 onset 24-Aug-2021 with Ibrutinib Film-Coated Tablet was reasonable Possibility. The reporter's causality for the events of Bruising popped up, COVID-19, Depression and Side effects/Moderna booster that mad patient does not feel well with Ibrutinib Film-Coated Tablet was Not Provided.  No treatment medication were provided.  The symptoms of COVID-19 pneumonia included COVID-19 and side effects/moderna booster that mad patient not feel well.  Company comment: This spontaneous case concerns a 57-year-old male patient with no relevant medical history reported, who experienced the unexpected  serious (hospitalization, medically significant) events of COVID-19 pneumonia and Coma that occurred after receiving a dose (reported as booster) of mRNA-1273 vaccine in the COVID-19 vaccination series. Latency could not be assessed as the date of vaccination was not available. Patient tested positive for SARS-CoV-2 test, was hospitalized for five days. Patient had also received a dose of PFIZER BIONTECH COVID-19 VACCINE previously (Interchange of vaccine products). No further information regarding risk factors, clinical course, investigations and treatment received were provided. The outcome of the events was recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 57-year-old male patient with no relevant medical history reported, who experienced the unexpected  serious (hospitalization, medically significant) events of COVID-19 pneumonia and Coma that occurred after receiving a dose (reported as booster) of mRNA-1273 vaccine in the COVID-19 vaccination series. Latency could not be assessed as the date of vaccination was not available. Patient tested positive for SARS-CoV-2 test, was hospitalized for five days. Patient had also received a dose of PFIZER BIONTECH COVID-19 VACCINE previously (Interchange of vaccine products). No further information regarding risk factors, clinical course, investigations and treatment received were provided. The outcome of the events was recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report.