Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19 immunisation, Diarrhoea, Food poisoning, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Revaccination with different COVID-19 vaccine; food poisoning with diarrhea/Vomiting; vaccine reaction with diarrhea/reaction with covid booster which caused diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (vaccine reaction with diarrhea/reaction with covid booster which caused diarrhea) and FOOD POISONING (food poisoning with diarrhea/Vomiting) in a 60-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) tablet for Chronic lymphoid leukemia and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included Fusion lumbar spine (The patient had screw that fractured after she had a surgery in her back for a lumbar fusion in 2020 that was causing her a lot of pain.) in 2020. Concurrent medical conditions included Chronic lymphoid leukemia.   On 01-Oct-2020, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. In 2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. In 2022, the patient experienced DIARRHOEA (vaccine reaction with diarrhea/reaction with covid booster which caused diarrhea) (seriousness criterion medically significant). On 27-Jul-2022, the patient experienced FOOD POISONING (food poisoning with diarrhea/Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). At the time of the report, DIARRHOEA (vaccine reaction with diarrhea/reaction with covid booster which caused diarrhea) and FOOD POISONING (food poisoning with diarrhea/Vomiting) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown.            No concomitant and treatment medication was reported. The patient had screw that fractured after having surgery in her back for a lumbar fusion in 2020 that was causing her a lot of pain. In 2021, she had biopsy on the lumbar and the results were not provided. Neurologist was checking her for next steps. She was doing Magnetic resonance imaging and computed tomography and the results were not provided. The patient had a reaction to her first covid vaccine where her breathing became shallowand rapid and she went to emergency room. In 2022, she had reaction with covid booster which caused diarrhea. Since 27-Jul-2022, she had food poisoning with vomiting and diarrhea and on 28 Jul 2022, she was feeling better.   Company Comment:  This is a spontaneous case concerning a 60-year-old, female patient with medical history of CHRONIC LYMPHOID LEUKEMIA, who experienced the unexpected serious (medically significant) events of diarrhoea and food poisoning. Patient had diarrhoea after the administration of a dose of mRNA-1273 vaccine, used as a booster dose. It is unknow when the event food poisoning occurred, hence, latency could not be assessed. The COVID-19 schedule has been started with a dose of Pfizer vaccine, a second and a booster dose with mRNA-1273 vaccine, hence,  Interchange of vaccine products is noted in this case. Patient underlying condition could be a confounder for the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 60-year-old, female patient with medical history of CHRONIC LYMPHOID LEUKEMIA, who experienced the unexpected serious (medically significant) events of diarrhoea and food poisoning. Patient had diarrhoea after the administration of a dose of mRNA-1273 vaccine, used as a booster dose. It is unknow when the event food poisoning occurred, hence, latency could not be assessed. The COVID-19 schedule has been started with a dose of Pfizer vaccine, a second and a booster dose with mRNA-1273 vaccine, hence,  Interchange of vaccine products is noted in this case. Patient underlying condition could be a confounder for the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.