Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of therapeutic response, Swelling
Clinical narrative: stated that she was getting positive results from Kybella treatment but then noticed that her skin is getting bigger; they remove fat from the chin/I am having an opposite effect where before I was showing a positive outcome and then along came the Pfizer vaccine; This is a spontaneous report from a contactable pharmacist (parent). A 24-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported) via intramuscular route of administration, administered in arm left on an unspecified date in Apr2021 (at the age of 24-year-old) at dose 2, single for covid-19 immunisation. Medical history was reported as none. Concomitant medication included deoxycholic acid (KYBELLA) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported) on an unspecified date in Apr2021 at dose 1, single for covid-19 immunisation. On an unspecified date in Jun2021 the patient experienced stated that she was getting positive results from Kybella treatment but then noticed that her skin is getting bigger. She is calling to see if there are reports of problems with Kybella treatment, where they remove fat from the chin. Any reports or information in receiving product and Kybella and reporting opposite effect of what it is supposed to be doing. Unfortunately, I am having an opposite effect where before I was showing a positive outcome and then along came the Pfizer vaccine and I was administered that, wondering and concerned if this has been reported and if it goes away. Reporter has received both doses. During the first dose nurse asked if had cosmetic fillers in the past week, indicated had not had a Kybella in a few weeks. Has studied the regulatory authority of product and Kybella regulatory authority. Do you have reports or questions, or events on this post vaccine of this happening. Do the negative effects go away. Has an appointment on Tuesday with HCP, well refuted plastic surgeon. Daughter and her have the same report. Both having negative outcomes and believes it is related to product. Reporter stated that they should have had chin reduction and is experiencing the direct opposite. Stated that her daughter received only three Kybella shots and stated that she was getting positive results from Kybella treatment but then noticed that her skin is getting bigger. Stated that it is reversing Kybella. Stated that she noticed it six weeks ago at the beginning of June. Stated that it is not getting any bigger but not getting any smaller. Stated that it is not esthetically what they are looking for. Patient details: Stated that she is 120 something pounds. Product details: Stated that she got the first shot the first week in April. Stated that she got first shot and the second one three weeks from that date. Does not have NDC, lot or expiration date. Unknown dose intramuscular in left arm. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Arm Left Upper. Time the Vaccination Was Given: 15:00. Adverse Event: stated that she was getting positive results from Kybella treatment but then noticed that her skin is getting bigger. Time of Onset: (24-hour clock): 0900 on 24 May 2021. Reporter seriousness for stated that she was getting positive results from Kybella treatment but then noticed that her skin is getting bigger: Medically significant. Verbatim event relatedness: Covid vaccine: stated that she was getting positive results from Kybella treatment but then noticed that her skin is getting bigger- Related. Patient did not require a visit to emergency room, physician office. Outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: As per available information, the causal association between the event skin disorder and the suspect drug BNT162B2 cannot be excluded. 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. Linked Report(s) : US-PFIZER INC-202100942400 Same reporter/drug/event, different patient