Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis infective, Oral infection
Clinical narrative: Joint infection; Oral infection; MARKETING PROGRAM NAME WAS NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. Other Case identifier(s): 22K-163-4229368-00 (Abbvie).  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 57 years 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 (Batch/Lot number: unknown); hydroxychloroquine phosphate (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRITIS INFECTIVE (medically significant), outcome "recovering", described as "Joint infection"; ORAL INFECTION (non-serious), outcome "recovering", described as "Oral infection". The action taken for adalimumab and hydroxychloroquine phosphate was dosage permanently withdrawn.  Clinical information: Causality for Humira (Adalimumab) The reporter's causality for the events of Mouth Infection and knee infection was not provided. Suspect drugs information: Suspect drugs (include generic name): Treatment Unblinded. Product-Reaction level: Seq.No. 1: Drug: Humira (Adalimumab), Unknown, Unknown, Route of Admin: 1) Subcutaneous 2) Subcutaneous; Indications for use: Unknown indication; Therapy Dates/Duration: 1) Unk  Discontinued, 2) Unk  Ongoing. Causality: 1) Oral infection (Oral infection), Actions taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: Yes. 2) Joint infection (Arthritis infective), Actions taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A.  Seq.No : 2: Drug: Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Injection) (Tozinameran), Unknown, Unknown, Unknown, Daily Dose: 1) First dose (1 in 1 once), 2) Second dose (1 in 1 once), 3) Booster dose (1 in 1 once), Indications for use: 2) Covid-19 Vaccination, Route of Admin: 1) Intra-muscular, 2) Intra-muscular, 3) Intra-muscular. Causality: 1) Oral infection (Oral infection), Actions taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A. 2) Joint infection (Arthritis infective), Actions taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Possible, Dechallenge: N/A. Seq.No. 3: Drug: Plaquenil (Hydroxychloroquine Phosphate) (Hydroxychloroquine Phosphate), Unknown, Unknown, Route of Admin: 1) Unknown, 2) Unknown, Indication for use: 1) Unknown indication, Therapy Dates/Duration: 1) Unk  Discontinued, 2) Unk  Ongoing  Causality: 1) Oral infection (Oral infection), Actions taken with drug: Drug discontinued, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: Yes. 2) Joint infection (Arthritis infective), Actions taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A.  Concomitant drugs and history: Concomitant drugs and dates of administration (Exclude those used to treat event): Concomitant Drugs Not Reported. Other relevant history: Not Reported  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  The reporter considered "joint infection" and "oral infection" 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: As per current available information, the causal association between the event 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.