Age: 56.0
Sex: F
Vaccine: COVID19, PNC20, COVID19
Symptoms: Fatigue, Vaccination site cellulitis
Clinical narrative: cellulitis of arm/started hurting/Arm burning hot/became red below injection site, arm started feeling heavy/arm extremely hot (low grade fever at times, arm swelled, arm pain increased & burning hit; felt fatigued; This is a spontaneous report and received from Other HCPs.  A 56-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 01Oct2024 as dose 1, single (Lot number: LM2219, Expiration Date: 29Mar2025) at the age of 56 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type II Diabetes mellitus", start date: Sep2022 (ongoing), notes: Mild; "Hypothyroidism" (ongoing), notes: Many years ago; "Bandaid adhesive allergies" (unspecified if ongoing); "Allergies to dust on rare occasions" (unspecified if ongoing); "Hyperlipidaemia" (ongoing), notes: Many years ago. Concomitant medication(s) included: METFORMIN taken for diabetes mellitus; COENZYME Q10 [UBIDECARENONE]; MULTIVITAMIN FOR WOMEN; METAMUCIL [PLANTAGO OVATA]; ROSUVASTATIN taken for blood cholesterol; SYNTHROID taken for thyroid disorder. Vaccination history included: boostrix/adacel (Dose 5 mL), administration date: 01Mar2018, when the patient was 50-year-old, for immunisation; fluzone 6mo +, administration date: 24Oct2023, when the patient was 55-year-old, for immunisation; influenza, unspecified, administration date: 17Jan2018, when the patient was 49-year-old, for immunisation; influenza, unspecified, administration date: 03Nov2018, when the patient was 50-year-old, for immunisation; influenza, unspecified, administration date: 21Oct2020, when the patient was 52-year-old, for immunisation; influenza, unspecified, administration date: 24Sep2021, when the patient was 53-year-old, for immunisation; influenza, unspecified, administration date: 03Oct2022, when the patient was 54-year-old, for immunisation; sarS-cov-2 (COVID-19) vaccine (PF, 30 mcg/0.3), administration date: 10Oct2021, when the patient was 53-year-old, for COVID-19 immunisation; sarS-cov-2 (COVID-19) vaccine (PF, 30 mcg/0.3), administration date: 03Oct2022, when the patient was 54-year-old, for COVID-19 immunisation; sarS-cov-2 (COVID-19) vaccine (PF, 30 mcg/0.3), administration date: 24Oct2023, when the patient was 55-year-old, for COVID-19 immunisation; influenza, unspecified, administration date: 24Oct2023, when the patient was 55-year-old, for immunisation; Comirnaty 12+ (covid) 23-24 pfs (Pfizer, left, HG4665), administration date: Dec2023, for COVID-19 immunisation; Flucelvax (Flucelvax PF INJ 2023-24, 5 ML), administration date: 2023, for immunisation; Flucelvax (Flucelvax 20, 0.5 ML, IM PFS (10 Pack)), administration date: 2024, for immunisation. The following information was reported: VACCINATION SITE CELLULITIS (medically significant) with onset 01Oct2024 at 15:00, outcome "recovered", described as "cellulitis of arm/started hurting/Arm burning hot/became red below injection site, arm started feeling heavy/arm extremely hot (low grade fever at times, arm swelled, arm pain increased & burning hit"; FATIGUE (non-serious) with onset 01Oct2024 at 15:00, outcome "recovered", described as "felt fatigued". Therapeutic measures were taken as a result of vaccination site cellulitis, fatigue. Additional information: Patient arm started hurting night of injection and began to get hot. Her arm was burning hot next day, became red below injection site, arm started feeling heavy, and she felt fatigued. Next day, redness spread down arm, arm extremely hot (low grade fever at times, arm swelled, arm pain increased and burning hit (radiating heat, arm felt heavy). The doctor put her on antibiotic treatment as precaution. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Cellulitis of arm-needed treatment.   Causality for "cellulitis of arm/started hurting/arm burning hot/became red below injection site, arm started feeling heavy/arm extremely hot (low grade fever at times, arm swelled, arm pain increased & burning hit" and "felt fatigued" was determined associated to device constituent of BNT162b2 omicron (kp.2) (malfunction).; Sender's Comments: A possibly contributory role of BNT162b2 omicron (kp.2) in triggering the onset of VACCINATION SITE CELLULITIS cannot be fully excluded, considering the temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202400275736 Same patient/event, different product;