Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Procedural site reaction, Swelling face
Clinical narrative: every where she had had filler injections are swollen except the left eye, her left eye is not swollen; every where she had had filler injections are swollen except the left eye/her doctor believes she is having a reaction with her fillers/bump on her right eye; under her right eye there was a large bump that was swollen; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via an unspecified route of administration in the left upper arm, on 07Jan2021 at single dose for COVID-19 immunisation. Relevant medical history included Hashimoto's disease from 2017 and ongoing, cosmetic filler injections got in her face within the last year and half or 2 years. Patient said that she knew that Allergan asked her doctor about her ongoing Hashimoto's as well. She takes medication for that. Patient also said that her white blood cell count runs low, like around 2 if they want to note that as an immune system thing and she confirmed that was an issue for her prior to receiving the COVID 19 vaccine. Family medical history included that her daughter has Hasimotos as well. Concomitant medications included unspecified medications for Hashimoto's disease. The patient previously received first dose of BNT162B2 (lot number: EI1685) via an unspecified route of administration in the left upper arm on 18Dec2020 at the year of 44 years at single dose for covid-19 immunisation. She said her doctor believes she is having a reaction with her fillers. She clarified fillers were like cosmetic injections got in her face. She thought the filler was called Allergan but she didn't have any other information about it. She did know her doctor did call Allergan and did a report with them. She thought it was like a big deal because it was not documented with Pfizer just with Moderna. She said the doctor was also going to call and report this as well. The doctor has not called yet but he said he was going to, she just left their office. Basically the places she had had filler injections within the last year and half or 2 years not have, under her right eye there was a large bump that was swollen and then the places that were called labial folds, the marionette lines where she had had filler there were all swollen and that was on the right side of her face and then on the left side the marionette lines were swollen as well so basically everywhere she had had filler injections were swollen except the left eye, the left eye is not swollen. And the places were swollen and hard. She first noticed the swelling yesterday 25Jan2021. The bump on her right eye was yesterday around 15:00 and then this morning (26Jan2021) it was much worse under her eye and she noticed the bumps on the right side at about 6 am this morning and around 9 am she began feeling it on the left side and it progressively has gotten worse since it started in all of those areas (26Jan2021). This case reported as serious. Patient did not visit Emergency Room, but she has been to 2 different physicians in physician office. No other vaccines administered on the same day as either dose of the suspect product. Patient did not have prior vaccinations within 4 weeks. Outcome of the events was not recovered.    Reporter assessed event everywhere she had had filler injections are swollen except the left eye, her left eye is not swollen as related to BNT162B2.; Sender's Comments: Based on available information a contributory role of BNT162B2 to reported events cannot be fully excluded. Consideration should also be given to the contribution from the cosmetic filler injections. 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.