Sex: M
Vaccine: COVID19
Symptoms: Crohn's disease, Device issue, Incorrect dose administered
Clinical narrative: experienced CROHNS DISEASE FLARE UP; experienced PEN MISFIRED/PUNCTURE FROM THE NEEDLE BUT MEDICATION WAS RUNNING DOWN ON STOMACH; experienced PEN MISFIRED/PUNCTURE FROM THE NEEDLE BUT MEDICATION WAS RUNNING DOWN ON STOMACH; FACILITATED COLLECT  This is a solicited report received from contactable reporter (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4156225-00.  A 17-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) for crohn's disease. Relevant medical history included: "Crohns disease" (unspecified if ongoing), notes: MODERATE TO SEVERE PEDIATRIC CROHN'S DISEASE. The patient's concomitant medications were not reported. The following information was reported: CROHN'S DISEASE (medically significant), outcome "recovering", described as "experienced CROHNS DISEASE FLARE UP"; INCORRECT DOSE ADMINISTERED (non-serious), DEVICE ISSUE (non-serious) all with onset 19Oct2021, outcome "recovered" (2021) and all described as "experienced PEN MISFIRED/PUNCTURE FROM THE NEEDLE BUT MEDICATION WAS RUNNING DOWN ON STOMACH". The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of crohn's disease. Clinical course: On an unknown date, the patient experienced crohns disease flare up. On 19Oct2021, the patient experienced pen misfired/puncture from the needle but medication was running down on stomach. in 2021, the pen misfired/puncture from the needle but medication was running down on stomach resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. 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. The patient was treated with prednisone. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of crohns disease flare up was not provided. The reporter's causality for the event(s) of pen misfired/puncture from the needle but medication was running down on stomach onset 19Oct2021 and pen misfired/puncture from the needle but medication was running down on stomach onset 19Oct2021 with HUMIRA(ADALIMUMAB) was a reasonable possibility. (Also reported as the reporter's causality for the events was no reasonable possibility).   The reporter considered "experienced crohns disease flare up" and "experienced pen misfired/puncture from the needle but medication was running down on stomach" 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 event of Crohn's disease aggravated is related to the suspect product BNT162B2 based on plausible temporal relationship. The events of Incorrect dose administered and device issue are unrelated to the suspect product BNT162B2, these are attributed to device issue malfunction. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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.