Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Dizziness, Eructation, Fatigue, Gastrooesophageal reflux disease
Clinical narrative: pain including at surgical incision sites; Headache; Dizziness; Brain Fog; Chills; Gastro (Gerd, burping, gas, stomach ache, constipation); Gastro (Gerd, burping, gas, stomach ache, constipation); Gastro (Gerd, burping, gas, stomach ache, constipation); Gastro (Gerd, burping, gas, stomach ache, constipation); nausea; high blood pressure; body aches; joint pain; fatigue; memory loss; dose 1,2,3 moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 24Sep2023 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: gluten" (unspecified if ongoing), notes: known allergies: Intolerance to dairy and gluten; "known allergies: Intolerance to dairy" (unspecified if ongoing), notes: known allergies: Intolerance to dairy and gluten; "High Blood Pressure" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Moderna covid-19 vaccine (other vaccine same date dose number=1,, other vaccine same date vaccine location=Right Arm), for COVID-19 Immunization; Moderna covid-19 vaccine (other vaccine same date dose number=2, other vaccine same date vaccine location=Right Arm), for COVID-19 Immunization; Moderna covid-19 vaccine (other vaccine same date dose number=3, other vaccine same date vaccine location=Right Arm), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Sep2023 at 15:00, outcome "not recovered", described as "dose 1,2,3 moderna"; BRAIN FOG (non-serious) with onset 24Sep2023 at 18:30, outcome "not recovered"; CHILLS (non-serious) with onset 24Sep2023 at 18:30, outcome "not recovered"; DIZZINESS (non-serious) with onset 24Sep2023 at 18:30, outcome "not recovered"; ABDOMINAL PAIN UPPER (non-serious), GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), ERUCTATION (non-serious), CONSTIPATION (non-serious) all with onset 24Sep2023 at 18:30, outcome "not recovered" and all described as "Gastro (Gerd, burping, gas, stomach ache, constipation)"; HEADACHE (non-serious) with onset 24Sep2023 at 18:30, outcome "not recovered"; PAIN (non-serious) with onset 24Sep2023 at 18:30, outcome "not recovered", described as "body aches"; FATIGUE (non-serious) with onset 24Sep2023 at 18:30, outcome "not recovered"; HYPERTENSION (non-serious) with onset 24Sep2023 at 18:30, outcome "not recovered", described as "high blood pressure"; ARTHRALGIA (non-serious) with onset 24Sep2023 at 18:30, outcome "not recovered", described as "joint pain"; AMNESIA (non-serious) with onset 24Sep2023 at 18:30, outcome "not recovered", described as "memory loss"; NAUSEA (non-serious) with onset 24Sep2023 at 18:30, outcome "not recovered"; INJECTION SITE PAIN (medically significant) with onset 24Sep2023 at 18:30, outcome "not recovered", described as "pain including at surgical incision sites". The event "dose 1,2,3 moderna" required physician office visit. The events "pain including at surgical incision sites", "headache", "dizziness", "brain fog", "chills", "gastro (gerd, burping, gas, stomach ache, constipation)", "nausea", "high blood pressure", "body aches", "joint pain", "fatigue" and "memory loss" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Sep2023) Negative, notes: Nasal Swab; (27Sep2023) Negative, notes: Nasal Swab; (28Sep2023) Negative, notes: Nasal Swab; (29Sep2023) Negative, notes: Nasal Swab; (02Oct2023) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of injection site pain, headache, dizziness, brain fog, chills, abdominal pain upper, gastrooesophageal reflux disease, eructation, constipation, nausea, hypertension, pain, arthralgia, fatigue, amnesia.Serious: No. Clinical course: dose received More than 3. The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.