Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Headache, Illness, Uveitis
Clinical narrative: Pfizer vaccine resulted in flare in immune system resulting in Uveitis; sick; headache; diarrhea; cough; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4162593.  A 43-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for uveitis. The patient's relevant medical history included: "Non-infectious Intermediate, Posterior and Panuveitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: UVEITIS (medically significant), outcome "unknown", described as "Pfizer vaccine resulted in flare in immune system resulting in Uveitis"; ILLNESS (non-serious), outcome "unknown", described as "sick"; HEADACHE (non-serious), outcome "unknown"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; COUGH (non-serious), outcome "unknown". The action taken for adalimumab was unknown.  Causalities: The reporter's causality for the event(s) of cough, diarrhea, headache and sick with Adalimumab Solution for Injection was Reasonable Possibility. The reporter's causality for the event(s) of Pfizer vaccine resulted in flare in immune system resulting in Uveitis with Adalimumab Solution for Injection was No Reasonable Possibility. The reporter's causality for the event(s) of cough, diarrhea, headache and sick with Pfizer BioNTech COVID-19 vaccine(Tozinameran) was Not Provided. The reporter's causality for the event(s) of Pfizer vaccine resulted in flare in immune system resulting in Uveitis with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility  Agency's opinion was that the causality for the event(s) of Pfizer vaccine resulted in flare in immune system resulting in Uveitis, cough, diarrhea, headache and sick with Adalimumab Solution for Injection was Not Provided.  Agency's opinion was that the causality for the event(s) of Pfizer vaccine resulted in flare in immune system resulting in Uveitis, cough, diarrhea, headache and sick with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  Assessment Results: For suspect drug HUMIRA: Sickness, Non-Health Care Professional, Global Introspection, Probable; Uveitis flare up, Non-Health Care Professional, Global Introspection, Not Related; Uveitis flare up, Regulatory Authorization Holder; Cough, Regulatory Authorization Holder; Cough, Non-Health Care Professional, Global Introspection, Probable; Diarrhea, Regulatory Authorization Holder; Diarrhea, Non-Health Care Professional, Global Introspection, Probable; Headache, Regulatory Authorization Holder; Headache, Non-Health Care Professional, Global Introspection, Probable. For Pfizer BioNTech COVID-19 vaccine: Cough, Regulatory Authorization Holder; Cough, Non-Health Care Professional, Global Introspection, Not Reported; Diarrhea, Regulatory Authorization Holder; Diarrhea, Non-Health Care Professional, Global Introspection, Not Reported; Headache, Regulatory Authorization Holder; Headache, Non-Health Care Professional, Global Introspection, Not Reported; Sickness, Regulatory Authorization Holder; Sickness, Non-Health Care Professional, Global Introspection, Not Reported; Uveitis flare up, Regulatory Authorization Holder; Uveitis flare up, Non-Health Care Professional, Global Introspection, Probable; For HUMIRA: Sickness, Regulatory Authorization Holder.  The reporter considered "pfizer vaccine resulted in flare in immune system resulting in uveitis" related to BNT162b2. The reporter's assessment of the causal relationship of "sick", "headache", "diarrhea" and "cough" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case, a possible causal association between all  the reported events and the suspect drug 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 RAs, Ethics Committees, and Investigators, as appropriate.