Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Laboratory test normal, Peripheral swelling, Rash, Swelling face
Clinical narrative: my eyes were painful; my eyes were itchy; Eyes swelling; my face were swelling; A little short of breath; Hands are still swollen, my arms are slightly swollen and so is my eyes; Dry rash on hand almost looks like dry eczema rash or psoriasis like it looks like it's a dry patchy rash; Severe headache almost like a migraine; I started to feel little bit, a little off; This is a spontaneous report from a contactable nurse, the patient.  A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1685), intramuscular in the left arm on 16Dec2020 (at the age of 49-years-old) as a single dose for COVID-19 immunization.  Medical history included hypertension and hot flashes. Concomitant medications included clonidine (MANUFACTURER UNKNOWN) taken for hot flashes, fish oil (MANUFACTURER UNKNOWN) for an unknown indication, omeprazole (MANUFACTURER UNKNOWN) for an unknown indication, spironolactone (MANUFACTURER UNKNOWN) as a diuretic, and multivitamin (MANUFACTURER UNKNOWN) for an unknown indication; all from unknown dates and unknown if ongoing.  On 16Dec2020, the patient experienced eyes were painful and itchy, eyes and face were swelling, a little short of breath, hands swollen, arms slightly swollen, dry rash on hand almost looks like dry eczema rash or psoriasis like it was a dry patchy rash, severe headache almost like a migraine, and felt a little bit off.  The clinical course was as follows: the patient received the vaccine on 16Dec2020 and waited 15 minutes and did not have any reaction. She went back to work. As she proceeded to work her shift, she started to feel little bit, a little off. She couldn't really describe it but thought it may have been psychological because she was just really watching heavily for any type of symptoms. She had worked an hour over her shift and it usually took her about 40 minutes to get home. When she got home around 21:00, her eyes were painful and itchy and when she looked in the mirror her eyes and face were swelling. Then, she became a little short of breath not to a point where she thought she needed oxygen, just a little short of breath. She called the hospital where she worked and talked to the manager and then they advised her to go the emergency room. At the emergency room, she received intravenous fluid, diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and dexamethasone (DECADRON) for treatment. She also took cetirizine (ZYRTEC), prednisone (MANUFACTURER UNKNOWN) and triamcinolone cream for the dry patchy rash. The patient stated that she had lab work done earlier in Dec2020 (before the vaccination) and everything was normal.  The clinical outcomes of the itchy eyes, eye swelling, hands swelling, and arms slightly swollen were not recovered and ongoing; while that of the little short of breath, dry patchy rash, headache, and feeling a little off, were unknown. The outcome of the eye pain was recovered on an unknown date in Dec2020; while that of the face swelling was recovering.; Sender's Comments: Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. 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