Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site vesicles, Thrombosis
Clinical narrative: Bubbling skin around injection site followed by a rash and blood clots; Bubbling skin around injection site followed by a rash and blood clots; Bubbling skin around injection site followed by a rash and blood clots; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not Avaliable). The reporter is the patient. Other Case identifier(s): 2K-163-4232658-00 (AbbVie).  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free for colitis ulcerative. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: THROMBOSIS (medically significant), INJECTION SITE VESICLES (non-serious), INJECTION SITE RASH (non-serious), outcome "recovered" and all described as "Bubbling skin around injection site followed by a rash and blood clots". The action taken for adalimumab was dosage not changed. The reporter considered "bubbling skin around injection site followed by a rash and blood clots" not related to bnt162b2. The patient reported events of non-serious bubbling skin around injection site followed by a rash and blood clots with humira (adalimumab). On unknown dates, the patient experienced bubbling skin around injection site followed by a rash and blood clots. On unknown dates, bubbling skin around injection site followed by a rash and blood clots resolved. Pfizer biontech covid-19 vaccine was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient had no Known allergies  Causality for humira (adalimumab): The reporter's causality for the event(s) of bubbling skin around injection site followed by a rash unknown onset and bubbling skin around injection site followed by a rash unknown onset with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of blood clots was not provided.  Causality for pfizer biontech covid-19 vaccine: The reporter's causality for the event(s) of Clot blood (Thrombosis) and Injection site rash (Injection site rash) with pfizer biontech covid-19 vaccine was a Not Related. The reporter's causality for the event(s) of Injection site vesicles was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the related event and the suspect BNT162B2 cannot be excluded. For Unrelated events there is no reasonable possibility of causal association between the events and the suspect BNT162B2 can be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.