Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Pruritus, Rash, Swelling face, Urticaria
Clinical narrative: hives; face swelling; itching; rash; This is a spontaneous report from a contactable nurse (patient). A 71-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EH9899), intramuscular in left arm on 22Dec2020 11:08 at single dose for COVID-19 vaccination. Medical history included ongoing blood pressure high, ongoing cholesterol, ongoing depression. Concomitant medication included atenolol (tablet, strength 50 mg) from an unknown date and ongoing for blood pressure high, simvastatin (tablet, strength 20 mg) from an unknown date and ongoing for cholesterol, paroxetine hydrochloride (PAXIL, tablet, strength 40 mg) from an unknown date and ongoing for depression. The patient experienced hives, face swelling, itching and rash on 27Dec2020. No additional vaccines administered on same date of the Pfizer suspect. Prior vaccination within 4 weeks was none. She got the first Covid 19 dose on 22Dec2020 and was fine, then on 27Dec2020 she had hives, itching, and face swelling for several days. Caller stated her lungs were clear and she was okay other than the extreme itching. The face swelling was what worried her. The hives and itching went away within about 36 hours. The face swelling kind of got worse for a couple of days before it went away. Caller verifies she recovered from the hives/rash/itching within 36 hours. She got a steroid shot and things like that and it went away pretty quickly. The face swelling was completely gone but did last for a good 5 days. She didn't know if this reaction was related to the vaccine. She wanted to call and let Pfizer know and see if there was any reports of anything else like that or similar to that type of reaction. She was not sure if that really matters or not except she was not sure about taking the booster. She was kind of leaning towards taking the second vaccine. She didn't have any breathing issues. She asked as far as the second dose after those side affects, was it recommended? Her doctor said she could get the second one and prescribed her an Epi pen and would give a dose of Benadryl at the time of the second vaccine. She may take some Benadryl before getting the second vaccine and have her EpiPen with her just in case. She hadn't seen her doctor about this experience with the COVID-19 vaccine. She only went to an urgent care. The caller stated she went to urgent care twice. She received a steroid shot but doesn't have any name, NDC/UPC, Lot number or expiration date for any of the medication she received. She probably threw that paperwork out. She knew she wasn't given anything the second time she went to the urgent care. The second time she went back was because the face swelling was getting worse. She was prescribed an EpiPen and was told to take Zyrtec which did help. Everything had gone away. She would consider these events to be medically significant because of the face swelling, it kind of scared her. She made the comment she was taking high blood pressure medicine and cholesterol medicine, but other than that she was very healthy. She was not really an allergic person. She had not had any testing done since she received the vaccine. She did have bloodwork done prior but not since the vaccine. The patient underwent lab tests and procedures which included blood work prior vaccine with unknown result. The outcome of hives, rash and itching was recovered on an unspecified date of Dec2020 (within about 36 hours); face swelling was recovered on 01Jan2021.; Sender's Comments: Based on the time gap between the vaccine and the events there is not a reasonable possibility that the reported events were related to the suspect product,  events are most likely due to patient underlying contributory factors 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.