Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Immunisation reaction, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: Diarrhea; Pain in extremity; Pain in elbow; Limbs stiffness; Joint stiffness; Vaccination related malaise; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4431379-00.  A 69-year-old female patient received BNT162b2 (BNT162B2), in 2020 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years intramuscular for covid-19 immunization; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION REACTION (non-serious) with onset 2020, outcome "unknown", described as "Vaccination related malaise"; DIARRHOEA (hospitalization), outcome "unknown", described as "Diarrhea"; PAIN IN EXTREMITY (non-serious), outcome "recovering"; ARTHRALGIA (non-serious), outcome "recovering", described as "Pain in elbow"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovering", described as "Limbs stiffness"; JOINT STIFFNESS (non-serious), outcome "recovering". The patient was hospitalized for diarrhoea (hospitalization duration: 4 day(s)). The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of diarrhoea. Clinical course: in 2020, the patient took the first shot of the Pfizer vaccination and she got sick. She was in the hospital for four days with uncontrollable diarrhea. She had to wear a diaper for four days. She had pain and stiffness in the hands arms and elbows. Pfizer BioNTech covid-19 vaccine (tozinameran) was also considered suspect.  The reporter's causality for the event(s) of uncontrollable diarrhea/had to wear a diaper, pain and stiffness in hands/arms/elbows unknown onset, pain and stiffness in hands/arms/elbows unknown onset, pain and stiffness in hands/arms/elbows unknown onset, pain and stiffness in hands/arms/elbows unknown onset and took first shot of Pfizer vaccination and got sick was not provided. Opinion is that there is no reasonable possibility that the events of uncontrollable diarrhea/had to wear a diaper, pain and stiffness in hands/arms/elbows unknown onset, pain and stiffness in hands/arms/elbows unknown onset, pain and stiffness in hands/arms/elbows unknown onset, pain and stiffness in hands/arms/elbows unknown onset and took first shot of Pfizer vaccination and got sick are related to HUMIRA (adalimumab).  Causality between events (Diarrhea, Pain in extremity, Pain in elbow, Limbs stiffness, Joint stiffness and Vaccination related malaise) and HUMIRA (Solution for injection in pre-filled pen) was Not reported by reporter and no reasonable possibility was assessed by manufacturer.  Causality between events (Diarrhea, Pain in extremity, Pain in elbow, Limbs stiffness, Joint stiffness and Vaccination related malaise) and Pfizer BioNTech covid-19 vaccine was reported as unknown by reporter and causality was not reported by manufacturer.  The reporter's assessment of the causal relationship of "diarrhea", "pain in extremity", "pain in elbow", "limbs stiffness", "joint stiffness" and "vaccination related malaise" 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 the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely 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.