Age: 77.0
Sex: F
Vaccine: RSV, COVID19, UNK
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Diarrhea; Vomited; Fever; it was 102 Fahrenheit; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 77-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 77 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Atrial fib" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA taken for crohn's disease; PROLIA taken for osteoporosis; COREG taken for hypertension; LOSARTAN; ELIQUIS taken for atrial fibrillation; OMEPRAZOLE; ATORVASTATIN taken for blood cholesterol increased; CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]. Vaccination history included: moderna covid-19 vaccine (Dose: 1, Administration date: 18Jan2021; LOT#: 012L20A), administration date: 18Jan2021, for COVID-19 Immunization; moderna covid-19 vaccine (Dose: 2, Administration date: 15Feb2021; LOT#: 029MZOA), administration date: 15Feb2021, for COVID-19 Immunization; moderna covid-19 vaccine (Dose: 3, Administration date: 16Aug2021; LOT#: O17E21A), administration date: 16Aug2021, for COVID-19 Immunization; moderna covid-19 vaccine (Dose: 4, Administration date: 29Jan2022; LOT#: 007J21A), administration date: 29Jan2022, for COVID-19 Immunization; moderna covid-19 vaccine (Dose: 5, Administration date: 04Oct2022; LOT#: AS7163D), administration date: 04Oct2022, for COVID-19 Immunization. The following information was reported: DIARRHOEA (medically significant), outcome "unknown", described as "Diarrhea"; VOMITING (non-serious), outcome "unknown", described as "Vomited"; PYREXIA (non-serious), outcome "unknown", described as "Fever; it was 102 Fahrenheit". The patient underwent the following laboratory tests and procedures: Body temperature: 102 Fahrenheit. Therapeutic measures were taken as a result of diarrhoea, vomiting, pyrexia. Clinical course: The consumer stated, "I have the COVID-19 injection, the Pfizer one on Monday (18Sep2023) and I just want to report, I had it around brand new at (name withheld) the pharmacist gave me the injection and about 6:30 and 7:00 at night, I started with diarrhea and vomiting, the vomiting lasted until I vomited 4 times until I can get them dose down and then I had Diarrhea probably around 10 times then I was able to take some Imodium but during the night the fever I spikes around 102 Fahrenheit temperature, so I never heard that was the reaction to the injection". The consumer further stated, "the previous shots I had were Moderna and I had never had a reaction from any of those, the other shots. I had been of Moderna, but this is the first time I have taken Pfizer." The patient took Zofran, Emollients and also took Tylenol as treatment. The consumer stated about the vaccines, "It did not have to be prescribed, no one prescribed it, I just chose to have it, you do not need doctor's prescription for it."  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA))to the event diarrhea cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.