Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: getting a slight headache.; Arm pain and fatigue starting 8 hours after vaccine.; Arm pain and fatigue starting 8 hours after vaccine.; General feeling of being unwell; Swelling and redness at injection site starting 12 hours after vaccine.; Swelling and redness at injection site starting 12 hours after vaccine.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 11:15 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), on 25Sep2023 as dose 1, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: All except obesity are control by medication; "Obesity" (unspecified if ongoing), notes: All except obesity are control by medication; "High cholesterol" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Supreventricular tachycardia" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL; CRESTOR; ZETIA; DILTIAZEM. Past drug history included: Phenergan, reaction(s): "Known allergies: Phenergan". Vaccination history included: bnt162b2 (Dose Number: 1, Batch/Lot No: EN6200), administration date: 05Mar2021, when the patient was 40-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 2, Batch/Lot No: ER2613), administration date: 06Apr2021, when the patient was 40-year-old, for COVID-19 immunization; bnt162b2 (Dose Number: 3, Batch/Lot No: 320308D), administration date: 01Nov2021, when the patient was 40-year-old, for COVID-19 immunization; bnt162b2;bnt162b2 omi ba.4-5 (Dose Number: 4, Batch/Lot No: GJ6665), administration date: 16Nov2022, when the patient was 41-year-old, for COVID-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 25Sep2023, outcome "recovering" and all described as "Swelling and redness at injection site starting 12 hours after vaccine."; PAIN IN EXTREMITY (non-serious) with onset 25Sep2023 at 20:30, outcome "recovering", FATIGUE (non-serious) with onset 25Sep2023 at 20:30, outcome "not recovered" and all described as "Arm pain and fatigue starting 8 hours after vaccine."; MALAISE (non-serious) with onset 25Sep2023 at 20:30, outcome "not recovered", described as "General feeling of being unwell"; HEADACHE (non-serious) with onset 25Sep2023 at 20:30, outcome "not recovered", described as "getting a slight headache.". Therapeutic measures were not taken as a result of headache, pain in extremity, fatigue, vaccination site swelling, vaccination site erythema, malaise. Additional information: Concomitant medication also included "vit d k2 coq10".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.