Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Peripheral swelling, Swelling face
Clinical narrative: swelling on her right side-face, her arm, hand, leg; swelling on her right side-face, her arm, hand, leg; severe allergic reaction; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 13:45 (Lot number: EW0170) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: since birth; "Allergy" (unspecified if ongoing), notes: lot of allergies to a lot of medications and food; "Type II diabetes mellitus" (unspecified if ongoing), notes: not diagnosed, until her late 20's; "Hypothyroidism" (unspecified if ongoing), notes: diagnosed with Grave's disease in her early 20's, clarifies she had Grave's disease first; "Grave's disease" (unspecified if ongoing), notes: diagnosed with Grave's disease in her early 20's, and clarifies this as first; "Ruptured eardrum" (unspecified if ongoing) and was prescribed Supra-dexameth, 0.3-0.1%, four drops in ear twice a day, Start: Unspecified and Stop: 29Mar 2021. Lot: 109RX, she thinks that is a 9. Expiry date: Dec2021. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1 on 29Mar2021, Lot Number:ER8727, Anatomical Location:Right arm), administration date: 29Mar2021, when the patient was 53 years old, for COVID-19 immunization, reaction(s): "swelling on her feet and hand". The following information was reported: HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "severe allergic reaction"; SWELLING FACE (non-serious) with onset 19Apr2021, outcome "recovered" (2021), PERIPHERAL SWELLING (non-serious) with onset 19Apr2021, outcome "unknown" and all described as "swelling on her right side-face, her arm, hand, leg". The event "swelling on her right side-face, her arm, hand, leg" was evaluated at the physician office visit. Therapeutic measures were taken as a result of swelling face.  Additional information: The patient had a second dose on 19Apr2021 at 13:45 and she did not react until 3 hours later. She initially had swelling in her hand, feet, and leg that progressed overnight. She tried to go to urgent care, but she was not treated, and was told that she had to go to the hospital for treatment. She did not go to the hospital because she had no trouble breathing or anything, and she knew when to use an EpiPen if that was needed. Then later, the whole right side became swollen- her face, her arm, her leg. The swelling did take about 3-4 weeks to go away, especially on her face. She clarifies that the right side of the face was still slightly swollen for a long time. She confirms she no longer has any swelling. The next day, the patient went to the doctor at the physician's office because the swelling on her face was her concern. She has a lot of compromising health conditions so the doctor could not really give her steroids and she was instructed to alternate between Benadryl and another Antihistamine for 3 days. The patient also wants to confirm if severe allergic reactions like swelling of hands, feet, legs, and face have been reported with Pfizer BioNTech Covid19 Vaccine. She knows a booster shot was recommended but wants to know what if Pfizer's advice on getting the booster shot if she did decide to get it. The patient stated that she knows some people had allergic reactions because her physician said a couple of others had come in. She wants to know, have there been other reports of this kind of reaction. The patient states she saw a doctor a week before she was going to get her COVID shot, and she asked if it was okay to get her COVID shot, and she was told it was fine. She was prescribed an ear drop, Supra-dexameth for a ruptured eardrum. The patient stated the day she went to get her first dose of the COVID vaccine was the last day of using her ear drops. Prior Vaccinations (within 4 weeks), or any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s), and AE(s) following prior vaccinations were none. The patient did not receive any vaccines administered on the same date, with the Pfizer vaccine considered suspect. The reported AE(s) did not require a visit to the emergency room.  No follow-up attempts are possible. No further information is expected.