Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Blood iron, Diarrhoea, Fatigue, Illness, Inappropriate schedule of product administration
Clinical narrative: Explosive diarrhea; Nausea; patient received two doses of the Moderna COVID-19 vaccine & a dose of the Pfizer/BioNTech COVID-19 vaccine; Moderna Dose 1 : 01-FEB-2021 , Dose 2 : 11-MAR-2021; Sick; Feeling tired with Imbruvica (Ibrutinib); This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Explosive diarrhea) and NAUSEA (Nausea) in a 69-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 products included non-company products IBRUTINIB (IMBRUVICA) for CLL and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No known allergies.  Concurrent medical conditions included Iron low since 2001. Concomitant products included IRON for Iron low.   In 2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 420 milligram once a day. On 26-Oct-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 : 01-FEB-2021 , Dose 2 : 11-MAR-2021). In 2021, the patient experienced ILLNESS (Sick) and FATIGUE (Feeling tired with Imbruvica (Ibrutinib)). On 11-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (Explosive diarrhea) (seriousness criterion hospitalization) and NAUSEA (Nausea) (seriousness criterion hospitalization). On 26-Oct-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (patient received two doses of the Moderna COVID-19 vaccine & a dose of the Pfizer/BioNTech COVID-19 vaccine). The patient was hospitalized for 7 days due to DIARRHOEA and NAUSEA. In 2021, ILLNESS (Sick) had resolved. In October 2021, DIARRHOEA (Explosive diarrhea) and NAUSEA (Nausea) had resolved. On 26-Oct-2021, INTERCHANGE OF VACCINE PRODUCTS (patient received two doses of the Moderna COVID-19 vaccine & a dose of the Pfizer/BioNTech COVID-19 vaccine) had resolved. At the time of the report, FATIGUE (Feeling tired with Imbruvica (Ibrutinib)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna Dose 1 : 01-FEB-2021 , Dose 2 : 11-MAR-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood iron: Low.         In 2021, patient received a rapid iron infusion at an infusion center and experienced explosive diarrhea and nausea for two days and was hospitalized for one week. Then the infusion specialist ran the infusion slow for the first two hours and then fast for the last 20 minutes. On 25-Oct-2021, patient saw oncologist. Imbruvica therapy resumed unchanged.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This spontaneous case concerns a 69-year-old, female patient with medical history of Chronic Lymphocytic Leukemia (CLL) treated with the co-suspect product Imbruvica (ibrutinib), who experienced the unexpected, serious (hospitalization) events of diarrhoea (explosive diarrhea) and nausea, and other unexpected and expected, non-serious events. The events diarrhoea and nausea occurred 7 months after receiving the second dose of the mRNA-1273 vaccine and 13 days after receiving the second dose of Imbruvica. The non-serious events illness and fatigue occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine and unknown number of days after receiving the second dose of Imbruvica. Of note, the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. It was reported that on an unspecified date in 2021, the patient received a rapid iron infusion for low iron level and experienced explosive diarrhea and nausea for 2 days. The infusion specialist ran the infusion slow for the first 2 hours and then fast for the last 20 minutes. The patient was hospitalized for 1 week. No further clinical information (including details about hospitalization and treatment) was available for medical review. However, the events had resolved at the time of the report. The reporter stated that the patient was off therapy for 2 weeks and Imbruvica therapy resumed unchanged. The reporter also stated that an alternative etiology for the events of diarrhoea, nausea and illness was the rapid Infusion. Of note, the second dose of the mRNA-1273 vaccine was given 38 days after the first dose (inappropriate schedule of product administration). The patient also received a dose (third dose in the COVID-19 vaccination series) of the Pfizer/BioNTech COVID-19 vaccine (interchange of vaccine products) approximately 7 months after receiving the second dose of the mRNA-1273 vaccine. The medical history of CLL remains a confounder for the event fatigue which is a common symptom of the disease. The history of co-suspect administration of Imbruvica remains a confounder for the events diarrhoea, nausea and fatigue which are common symptoms of the medication. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 69-year-old, female patient with medical history of Chronic Lymphocytic Leukemia (CLL) treated with the co-suspect product Imbruvica (ibrutinib), who experienced the unexpected, serious (hospitalization) events of diarrhoea (explosive diarrhea) and nausea, and other unexpected and expected, non-serious events. The events diarrhoea and nausea occurred 7 months after receiving the second dose of the mRNA-1273 vaccine and 13 days after receiving the second dose of Imbruvica. The non-serious events illness and fatigue occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine and unknown number of days after receiving the second dose of Imbruvica. Of note, the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. It was reported that on an unspecified date in 2021, the patient received a rapid iron infusion for low iron level and experienced explosive diarrhea and nausea for 2 days. The infusion specialist ran the infusion slow for the first 2 hours and then fast for the last 20 minutes. The patient was hospitalized for 1 week. No further clinical information (including details about hospitalization and treatment) was available for medical review. However, the events had resolved at the time of the report. The reporter stated that the patient was off therapy for 2 weeks and Imbruvica therapy resumed unchanged. The reporter also stated that an alternative etiology for the events of diarrhoea, nausea and illness was the rapid Infusion. Of note, the second dose of the mRNA-1273 vaccine was given 38 days after the first dose (inappropriate schedule of product administration). The patient also received a dose (third dose in the COVID-19 vaccination series) of the Pfizer/BioNTech COVID-19 vaccine (interchange of vaccine products) approximately 7 months after receiving the second dose of the mRNA-1273 vaccine. The medical history of CLL remains a confounder for the event fatigue which is a common symptom of the disease. The history of co-suspect administration of Imbruvica remains a confounder for the events diarrhoea, nausea and fatigue which are common symptoms of the medication. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.