Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Initial swelling at injection site/ worse swelling/Day 2 after, swelling has increased from golf ball size to almost baseball; pain at injection site; redness/redness has migrated and is a larger area; it was warm to the touch; extremely itchy all day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 10Oct2023 at 18:00 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Choledochal cyst type 1" (unspecified if ongoing); "pcos" (unspecified if ongoing); "allergy induced asthma" (unspecified if ongoing); "rosacea" (unspecified if ongoing); "allergies" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL]; ALEVE; FLONASE [FLUTICASONE PROPIONATE]; METRONIDAZOLE; VITA FUSION". Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Acetaminophen, reaction(s): "Known allergies: Acetaminophen"; Aspirin, reaction(s): "sensitivity/ Allergy to Aspirin", notes: sensitivity; Benzoic acid, reaction(s): "Known allergies: Benzoic acid". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 11Oct2023 at 06:00, outcome "not recovered", described as "Initial swelling at injection site/ worse swelling/Day 2 after, swelling has increased from golf ball size to almost baseball"; VACCINATION SITE PRURITUS (non-serious) with onset 11Oct2023 at 06:00, outcome "not recovered", described as "extremely itchy all day"; VACCINATION SITE WARMTH (non-serious) with onset 11Oct2023 at 06:00, outcome "not recovered", described as "it was warm to the touch"; VACCINATION SITE PAIN (non-serious) with onset 11Oct2023 at 06:00, outcome "not recovered", described as "pain at injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 11Oct2023 at 06:00, outcome "not recovered", described as "redness/redness has migrated and is a larger area". Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain, vaccination site erythema, vaccination site warmth, vaccination site pruritus.  Additional information: That was for shot 5 the newest Pfizer COVID vaccine. Initial swelling and pain at injection site started the next morning and by the afternoon there was redness worse swelling and it was warm to the touch. Day 2 after, swelling had increased from golf ball size to almost baseball, redness had migrated and was a larger area, still warm to the touch and extremely itchy all day. Reportedly, the patient did not have Covid prior to vaccination. The patient was not tested for Covid post vaccination.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.