Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling of her leg and cheeks; swelling of her leg and cheeks; Left Knee Swelling; Swelling on inside of Jaws; pain in her arm; Edema; swelling and pain at the site of the shot; swelling and pain at the site of the shot; This is a spontaneous report from a contactable nurse. A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN5318), dose 1 via an unspecified route of administration in arm left on 10Feb2021 at 10:10 as single dose for COVID-19 immunisation. Medical history included allergy to arthropod bite from an unknown date and unknown if ongoing specifically fire ants and spiders. Concomitant medication included prednisone (PREDNISONE) taken for hypersensitivity, start and stop date were not reported. Caller reports that she received her first vaccine dose and 4 days later she had some symptoms of pain in her arm and Edema, with swelling of her leg and cheeks. She reports that has the same type of reaction with fire ant because she is allergic to them. She reports that she has seen her HCP who prescribed her some prednisone but he was not able to provide guidance of whether or not she should get the second dose of the vaccine. She calls today for guidance. she had a reaction like she does for insect bites, she started swelling up. She states that she took Benadryl on Wednesday 10Feb2021. She states the arm was painful and swollen and two to three days later her left leg was swollen along with the inside of her jaw was swollen. Caller states that she took some prednisone because she got scared. Caller asking if she should take the second one or wait until a third comes out if they do release that? Arm Pain and Swelling: States it lasted for 5-7 days, well actually it lasted 14 days because she had a pain now and then. Treatment: Took Prednisone 10mg med dose where she takes for ant bites, like Z-pack and you take so many one day and level off back to one. Clarifies that Benadryl was taken the first day or two, and then she saw more edema on Saturday and how bad it had gotten so she took the Prednisone since the Benadryl wasn't working. Also states that she took Tylenol because it hurt. She states that like with the insect bites, the swelling keeps on getting bigger and bigger. It starts out a little bit and then the edema spreads and her whole hands swell. States she noticed by Saturday the edema went down to her left knee. Patient was not hospitalized nor admitted to an Intensive Care Unit, no organ involvement. Communication: PC Filed. Caller provided with Report Reference. The caller was provided with the website, and the phone number for company, # opt. 3, and hours of operation 8:00-20:00 Mon-Sun, prior to cold transfer to wait in queue, due to high call volumes in company. Is there a Product Complaint: Yes Description of Product Complaint: Description of complaint: Calling to report adverse events from the COVID Vaccine. States that she took Benadryl for the swelling but it did not help. Lot: 1642806 Expiration: Dec20 UPC:#. Dosage: 25mg liquid gels. Outcome of the event pain in extremity, swelling and pain at the site of the shot, left knee swelling, swelling on inside of jaws was recovered on unspecified date of 2021, for the event edema, swelling of her leg and cheeks unknown   Follow-up (01Jul2021): Follow-up attempts completed. No further information expected.