Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Presyncope, Swelling
Clinical narrative: she felt like she was going to pass out; Headache; Red and itchy eyes; Red and itchy eyes; swelling, redness and puffiness underneath the eyes on; swelling, redness and puffiness underneath the eyes on; swelling, redness and puffiness underneath the eyes on; This is a Spontaneous report based on the information received by Pfizer from the Regulatory Authority (Galderma Reference number: GL-030521-5822). A contactable Nurse reported for a patient:  A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: unknown), via unspecified route of administration, on 23Feb2021 (at the age of 68-year-old) as a dose 2, single for COVID-19 immunization. The patient medical history included supraventricular tachycardia, high blood pressure, juvederm, juvederm Ultra Plus, Restylane L on 08Jan2021 patient was injected 1 syringe, Flu on 10Sep2020. The patient had a history of codeine allergies. Patient was taking Restylane Fillers prior to Pfizer.The concomitant medication of the patient included budesonide, formoterol fumarate (SYMBICORT) inhaler, metoprolol (METOPROLOL), magnesium (MAGNESIUM), rabeprazole sodium (ACIPHEX) and potassium bicarbonate (POTASSIUM BICARBONATE). The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown), on 01Feb2021 as dose 1, single for COVID-19 immunization. Patients receive Flu (10Sep2020) and Shingles (Feb2020) vaccines for other conditions prior to the event being reported. Patient had not received any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 vaccine prior to the event being reported. Patient had not received any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. On 08Jan2021 patient was injected with 2 syringes of Restylanem Kysse, 1 syringe of Restylane L and 5 syringes of Restylane Lyft (total mLs per product injected unknown to Health Care Professional; HCP stated that the doctor's notes say 0.5cc,0.8 cc,1cc,1.5cc ,1.8cc but patient was unsure with fillers each dose pertained to). Patient was injected under eyes, around lips and part of the chin up to nasal flares. Patient received 0.5cc under each eye; 0.8cc (right side of the lip/corner of her mouth); 0.5 cc (left side of lip); 0.8 cc right side of chin and 0.8cc left side of chin (HCP unsure which product injected to each area). Health Care Professional confirmed the patient received COVID -19 (Pfizer) vaccine first dose in Feb2021 and second dose in Mar2021 but did not have the exact dates available. On 03Mar2021 the patient experienced swelling, redness and puffiness underneath the eyes on, headache, red and itchy eyes. On 04Mar2021 the patient felt like she was going to pass out and had more swelling. Health care professional was not sure if patient has had other vaccines or dental procedures in the past 6-12 months. The patient took Benadryl and Tylenol and applied ice as treatment. Patient contacted the health Care professional but was not given any specific advice. The swelling, redness, puffiness was still there but was improving. On Mar2021 the patient looks better. Outcome of the reported event of patient felt like she was going to pass out was recovered on 05Mar2021 and all other events was recovered on unspecified date of 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.