Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Skin lesion, Tenderness, Vaccination site cellulitis
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Apr2022 at 09:00 as dose 3 (booster), single (Lot number: FK9894) at the age of 52 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Migraines (intermittent and few)" (unspecified if ongoing); "Cashews and avocados" (unspecified if ongoing); "Cashews and avocados" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid19 vaccine (DOSE 2, Manufacturer unknown, Dose Number: 2, Batch/Lot No: 301308A, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 26Sep2021, when the patient was 51-year-old, for COVID-19 immunization; Covid19 vaccine (DOSE 1, Manufacturer unknown, Dose Number: 1, Batch/Lot No: EW0217, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 05Sep2021, when the patient was 51-year-old, for Covid-19 Immunization. The following information was reported: PYREXIA (disability) with onset 04Apr2022 at 11:30, outcome "not recovered", described as "Fever"; HEADACHE (disability) with onset 04Apr2022 at 11:30, outcome "not recovered", described as "bad headache"; PAIN (disability) with onset 04Apr2022 at 11:30, outcome "not recovered", described as "body aches"; VACCINATION SITE CELLULITIS (disability) with onset 04Apr2022 at 11:30, outcome "not recovered", described as "cellulitis at injection site"; CHILLS (disability) with onset 04Apr2022 at 11:30, outcome "not recovered"; FATIGUE (disability) with onset 04Apr2022 at 11:30, outcome "not recovered"; ARTHRALGIA (disability), JOINT STIFFNESS (disability) all with onset 04Apr2022 at 11:30, outcome "not recovered" and all described as "joint pain/stiffness"; TENDERNESS (disability) with onset 04Apr2022 at 11:30, outcome "not recovered", described as "tenderness at site"; BREAST PAIN (disability), BREAST MASS (disability), outcome "not recovered" and all described as "Breast pain/lumps in left breast"; SKIN LESION (disability), outcome "not recovered", described as "sores inside right nostril and under nose"; MUSCULAR WEAKNESS (disability), outcome "not recovered", described as "muscle weakness". The events "fever", "tenderness at site", "chills", "body aches", "bad headache", "cellulitis at injection site", "fatigue", "joint pain/stiffness", "breast pain/lumps in left breast", "sores inside right nostril and under nose" and "muscle weakness" required physician office visit. The patient underwent the following laboratory tests and procedures: Labs: (unspecified date) Unknown results; SARS-CoV-2 test: (07Apr2022) Negative, notes: Nasal Swab; (18Apr2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of pyrexia, tenderness, chills, pain, headache, vaccination site cellulitis, fatigue, arthralgia, joint stiffness, breast pain, breast mass, skin lesion, muscular weakness. Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. 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.