Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Contusion, Erythema, Lip swelling, Skin induration, Swelling face
Clinical narrative: swelling; skin around the chin became hard and hyperemic; skin around the chin became hard and hyperemic; Swelling began to spread to lower lip; Bruising; This is a spontaneous report from a contactable healthcare professional. A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 20Apr2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation; hyaluronic acid (RESTYLANE injection), via an unspecified route of administration from 06May2021 (Batch/Lot number was not reported), at 0.5cc to the lips for an unspecified indication; and botulinum toxin type a haemagglutinin complex (DYSPORT injection), via an unspecified route of administration from 06May2021 (Batch/Lot number was not reported), at 180U to the glabellar, forehead, crows feet and platysmal band for an unspecified indication. The patient was also injected with 1cc restylane defyne (lot 18567) and Restylane Lyft to the cheeks, via unspecified route of administration from 06May2021 for unspecified indications. Medical history included osteoporosis, thyroid condition, and hypertension. The patient's concomitant medications were not reported. The patient previously took thyroxin, vitamin d [colecalciferol], biphosphonate, lisinopril sertraline, and vitamin B7. The patient previously received bnt162b2 for covid-19 immunisation in Mar2021. On an unspecified date, the patient had significant swelling within 5 minutes of the restylane defyne and swelling increased quite a bit, skin around the chin became hard and hyperemic, it really looked bad. Swelling began to spread to lower lip during the appointment. After about 12 minutes, the reporter stated that she injected the chin with 3cc of hylenex and noticed it softened after about 5 minutes, but still swollen; used nitropaste, warm compress and gave prescription for 40 mg prednisone which she reported patient took at 17:00 and the event was resolved by 20:00. The reporter stated that the patient had only had some bruising left from the hylenex. It was also reported that patient has had all the products mentioned before on 19Dec2020 without use. The patient has not had any other vaccine in the last 6-12 months, no illness reported in the last month and no dental procedures in the 6-12 months. The action taken in response to the events for hyaluronic acid and botulinum toxin type a haemagglutinin complex was unknown. Outcome of events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the reported events with BNT162b2 can not be completely 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.