Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Nausea
Clinical narrative: Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Moderate injection site redness; Mild injection site swelling; Moderate fever (101.3 to102°F); Severe fatigue with significant interference with activity; Moderate malaise/feeling sick present with some interference with activity; Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting; Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting; Headache that interfered with activity OR required repeated use of a non prescription pain reliever; This is a spontaneous report received from a Consumer or other non HCP.  An adult patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Jan2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 10Jan2024, outcome "not recovered", described as "Headache that interfered with activity OR required repeated use of a non prescription pain reliever"; VACCINATION SITE SWELLING (non-serious) with onset 10Jan2024, outcome "not recovered", described as "Mild injection site swelling"; PYREXIA (non-serious) with onset 10Jan2024, outcome "not recovered", described as "Moderate fever (101.3 to102°F)"; VACCINATION SITE PAIN (non-serious) with onset 10Jan2024, outcome "not recovered", described as "Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)"; VACCINATION SITE ERYTHEMA (non-serious) with onset 10Jan2024, outcome "not recovered", described as "Moderate injection site redness"; MALAISE (non-serious) with onset 10Jan2024, outcome "not recovered", described as "Moderate malaise/feeling sick present with some interference with activity"; NAUSEA (non-serious), VOMITING (non-serious) all with onset 10Jan2024, outcome "not recovered" and all described as "Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting"; FATIGUE (non-serious) with onset 10Jan2024, outcome "not recovered", described as "Severe fatigue with significant interference with activity". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: The following was experienced by the patient as per COVID-19 Survey Safety Notification (which includes worst level of intensity): Moderate injection site pain interfering with activity (2), Mild injection site tenderness (tender to touch) (1), Moderate injection site redness (2), Mild injection site swelling (1), Moderate fever (101.3 to 102 °F) (2), Severe fatigue with significant interference with activity (3), Moderate malaise/feeling sick present with some interference with activity (2), Moderate nausea/vomiting and some interference with activity or greater than 2 episodes of nausea/vomiting (2), and Headache that interfered with activity OR required repeated use of a nonprescription pain reliever (2). Muscle pain (0) and Joint pain (0) were not present.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.