Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site pruritus
Clinical narrative: pain and redness at injection site which evolved to a harder lump and the next day itching on that lump; Chills; Pain and redness at injection site which evolved to a harder lump and the next day itching on that lump; pain and redness at injection site which evolved to a harder lump and the next day itching on that lump; pain and redness at injection site which evolved to a harder lump and the next day itching on that lump; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 at 09:00 as dose 1, single (Lot number: HF9275) at the age of 51 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR; VITAMIN D 2000; AMPK. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 02Mar2021, for COVID-19 immunisation; bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 23Mar2021, for COVID-19 immunisation; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Batch/Lot No: FH8030, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 17Nov2021, for COVID-19 immunisation, reaction(s): "COVID-19 vaccine booster", "first side effects of soreness and pain on the injection site", "body aches", "Malaise", "elevated body temperatures/Fever", "soreness on the arm became the size of an egg/Vaccination site mass"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Batch/Lot No: FP7138, Location of injection: Arm Left, Route of Administration: Intramuscular), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 03Oct2023 at 21:00, outcome "recovered" (11Oct2023); VACCINATION SITE PAIN (non-serious) with onset 03Oct2023 at 21:00, outcome "recovered" (11Oct2023), described as "Pain and redness at injection site which evolved to a harder lump and the next day itching on that lump"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE MASS (non-serious) all with onset 03Oct2023 at 21:00, outcome "recovered" (11Oct2023) and all described as "pain and redness at injection site which evolved to a harder lump and the next day itching on that lump"; VACCINATION SITE PRURITUS (non-serious) with onset 04Oct2023, outcome "recovered" (11Oct2023), described as "pain and redness at injection site which evolved to a harder lump and the next day itching on that lump". Therapeutic measures were not taken as a result of chills, vaccination site pain, vaccination site erythema, vaccination site mass, vaccination site pruritus.  Additional Information: Twelve hours after the shot chills for 3 hours, no fever, pain and redness at injection site which evolved to a harder lump and the next day itching on that lump until the following week. All side effects resolved by 11Oct2023.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101641492 Same patient, different vaccine doses/events;