Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, FLUC3
Symptoms: Abdominal pain, Diarrhoea, Interchange of vaccine products, Off label use, Product use issue
Clinical narrative: product=COVID 19, brand=Pfizer, dose number=4/prev dose product=COVID 19, prev dose brand=Moderna, prev dose dose number=3/prev dose dose number=2/prev dose dose number=1; patient received Pfizer bivalent covid-19 vaccine and Flucelvax on the same day; patient received Pfizer bivalent covid-19 vaccine and Flucelvax on the same day; Severe abdominal pain; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: 0149694) at the age of 45 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 22Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Non-smoker" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; FIBERCON; ESCITALOPRAM; CRESTOR; LEXAPRO. Vaccination history included: moderna (Dose 1, Route: IM, Lot number= 012L20A,), administration date: 13Jan2021, when the patient was 44-year-old, for COVID-19 immunization; moderna (Dose 2, Route: IM, lot number= 030L20A), administration date: 10Feb2021, when the patient was 44-year-old, for COVID-19 immunization; moderna (Dose 3, Route: IM, lot number=032F21A,), administration date: 02Nov2021, when the patient was 45-year-old, for COVID-19 immunization. The following information was reported: DIARRHOEA (non-serious) with onset 2022, outcome "recovered" (2022), described as "Diarrhea"; ABDOMINAL PAIN (non-serious) with onset 2022, outcome "recovered" (2022), described as "Severe abdominal pain"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 22Sep2022, outcome "unknown" and all described as "patient received Pfizer bivalent covid-19 vaccine and Flucelvax on the same day"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "product=COVID 19, brand=Pfizer, dose number=4/prev dose product=COVID 19, prev dose brand=Moderna, prev dose dose number=3/prev dose dose number=2/prev dose dose number=1". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no other vaccine in four weeks; had no covid prior vaccination; no known allergies. Pfizer product did not had a causal effect to the adverse event. Patient received Pfizer bivalent occurred 22Sep2022 and Covid symptoms started on 01Oct and Positive Covid test was 03Oct. Patient had a positive test for SARS-CoV2. Nasal swab reverse transcription-polymerase chain reaction (RT-PCR) test or nucleic acid amplification-based test (NAAT) or antigen test).: 03Oct2022 Positive via Binax nasal. It was unknown that patient had SARS-CoV2 antibodies at diagnosis. Patient was not hospitalized, not admitted to an Intensive Care Unit and not still hospitalized. It was unknown if patient discharged and had SARS-COV2 antibodies at hospital discharge. Patient did not display clinical signs at rest indicative of severe systemic illness. Patient not required supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Patient did not had any new or worsened symptoms/signs during the COVID-19 illness experienced. Patient did not had Multi organ Failure, Respiratory, Dyspnea, Tachypnea, Hypoxemia, COVID-pneumonia, Acute Respiratory Distress Syndrome (ARDS), Cardiovascular, Heart failure, Cardiogenic shock, Acute myocardial infarction, arrhythmia, Myocarditis, other condition, Vascular, Deep vein thrombosis, Pulmonary embolism, Limb ischemia, asculitis, Other (in particular any other thromboembolic events), Renal, Acute kidney injury, Renal failure, Neurological, Altered consciousness, Convulsions/seizures, Encephalopathy, Meningitis, cerebrovascular accident, Hematological: No, Thrombocytopenia, Disseminated intravascular coagulation, Dermatological, Chilblains, Erythema multiform, OTHER (e.g. multisystem inflammatory syndrome [MIS]): No. Patient had Gastrointestinal/Hepatic, Diarrhea, Abdominal pain: Yes. Symptoms started as severe abdominal pain and diarrhea that resolved on 24hrs (eligible) Oct Tx. Patient not received any additional therapies for COVID-19. Patient did not required the initiation of new medication or other treatment or procedure. Patient's outcome with COVID-19: Recovered (Checked). Patient did not retested for SARS-CoV2 antigen test. Patient was not a smoker/former smoker. Patient taking medications routinely prior to the event being reported was Crestor 20mg QD, Fibercon BID and Lexapro 10mg QD. Patient did not had any pre-existing diseases worsened during the SARS-CoV2 infection.. Patient had been been treated with immune-modulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination.  Follow-up (17Oct2022): This is a spontaneous follow-up report received from a contactable Pharmacist. This Pharmacist (Patient) reported in response to HCP letter sent to a cross referenced case which included that: Updated information included: Historical Vaccine (Lot number and administration date of 2nd Dose (Moderna)), Lab data, Suspect drug (Lot number and route of administration), concomitant medications (Crestor, Lexapro), event (Diarrhea and severe abdominal pain) and additional information.