Sex: F
Vaccine: COVID19, UNK
Symptoms: Hysterectomy, Illness, Immunisation, Post procedural infection, Psoriasis
Clinical narrative: booster COVID-19 Vaccine; Sick; Psoriasis; Hysterectomy; Infection caused by having a hysterectomy; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4199720-00 (Agency).  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for psoriasis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, 1)Intra-muscular), for Covid-19 immunization, reaction(s): "second one was mild"; Bnt162b2 (Dose 1, 1)Intra-muscular), for Covid-19 immunization, reaction(s): "first Covid vaccine nothing to reported,". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster COVID-19 Vaccine"; ILLNESS (medically significant), outcome "unknown", described as "Sick"; PSORIASIS (medically significant), outcome "not recovered", described as "Psoriasis"; HYSTERECTOMY (medically significant), outcome "unknown", described as "Hysterectomy"; POST PROCEDURAL INFECTION (medically significant), outcome "recovering", described as "Infection caused by having a hysterectomy". The action taken for adalimumab was unknown. Patient reported that, with first Covid vaccine nothing to reported, second one was mild, booster caused her to be sick for several days. Psoriasis had cleared up approximately 75 percent. Infection caused by having a hysterectomy and physician did not send her home with antibiotic. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown date, patient received COVID-19 Vaccine manufactured by Pfizer/BioNTech. On unknown date, patient received booster COVID-19 Vaccine manufactured by Pfizer/BioNTech. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. Causality for Humira (adalimumab) the reporter's causality for the event(s) of infection caused by hysterectomy unknown onset and booster vaccine caused sick was not provided. the reporter's causality for the event(s) of psoriasis and infection caused by hysterectomy unknown onset with Humira (adalimumab) was a reasonable possibility. withheld opinion was that there was no reasonable possibility that the events of infection caused by hysterectomy unknown onset, booster vaccine caused sick and psoriasis are related to Humira(adalimumab). withheld opinion was that the event of infection caused by hysterectomy unknown onset is not assessable. It was reported that reporter's causality for the BNT162B2 to the events of Hysterectomy, Psoriasis and Postoperative infection was not reported and for the event Sickness was possible. The reporter considered "sick" related to bnt162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The events of Immunisation, Illness and Psoriasis are related to the suspect product BNT162B2 based on plausible temporal relationship. The confounding factor for Psoriasis is patient's underlying medical condition of Psoriasis The event of hysterectomy and post procedural infection are not related to suspect product BNT162B2 since chronic medical conditions are more likely indications for hysterectomy in this elderly female patient. 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.