Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Swelling, Swelling face
Clinical narrative: neck swelling/Neck is swollen; The face and jaw are also swollen/her jaw were swollen; neck/tender to touch; This is a spontaneous report from a contactable other nurse (patient). A 47-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number and expiry date not reported), via an unspecified route of administration, administered in left deltoid on 14Aug2021 (at the age of 47 years old) as dose 1, single for covid-19 immunisation. Medical history included blood pressure (normal) from an unknown date and unknown if ongoing. The patient has no allergies. Concomitant medications included ongoing losartan at 25 mg, once a day for blood pressure; ongoing ascorbic acid (VITAMINS C) at an unknown dose once a day; ongoing calcium carbonate, colecalciferol (VITAMIN D 2000) at an unknown dose once a day; and estradiol at 2 mg, twice a day (once in the morning and once at night). Patient mentioned that she was on regular blood pressure medicine and hormones she has been taking for years (unspecified). The patient received her 1st dose of the Pfizer COVID-19 Vaccination on Saturday, 14Aug2021. She woke up the morning of 17Aug2021 with neck swelling and her face and her jaw were swollen. The patient was calling to see if this was normal side effect of the 1st dose of the Pfizer COVID-19 Vaccination. Patient further described that neck was swollen on the side the patient received the first dose Pfizer Covid Vaccine, the face and jaw were also swollen. The patient stated she was not sure if this had anything to do with the Pfizer Covid Vaccine. Patient stated that she was currently out of town and unable to seek medical care from her primary healthcare provider. She did mention seeking HCP through an urgent care system in the meantime while out of town. For the event neck was swollen, the patient stated this was the same and was also like tender to the touch. When asked serious criteria, the patient stated this was significant enough but not life threatening. This was significant and she stated she should get an anti-inflammatory or something. For the event, the face and jaw were also swollen, this was the same and was medically significant. The patient mentioned that this was the only new medication that has been injected into the caller's body. Patient did not receive any recent vaccines for any other conditions prior to the events being reported. Patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. Patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient was not hospitalized or admitted to an intensive care unit and had not been in the emergency department. The patient was trying to see if she should go to urgent care of something. No laboratory tests or diagnostic studies performed. Therapeutic measures were taken as a result of the events reported wherein in patient took anti-histamines. The outcome of the events was not recovered (reported as ongoing and persistent).  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Based on current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Neck swelling, Facial swelling and Neck pain. The case will be reassessed further upon receipt of additional information.  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.