Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Wrong technique in product usage process
Clinical narrative: not noticed green button, turned pen upside down/applied pressure/depressing white needle sleeve to thumb; the patient experienced needle stick injury; not noticed green button, turned pen upside down/applied pressure/depressing white needle sleeve to thumb; not noticed green button, turned pen upside down/applied pressure/depressing white needle sleeve to thumb; bleeding thumb; Injection site pain; He received 3rd dose COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-4207813-00 (MFR. CONTROL NO).  A 75 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 17Nov2021 (Lot number: 3303080) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), first regimen subcutaneous from Oct2020 (Batch/Lot number: unknown) to 18Dec2021 at 150 mg (150 mg (1 in 12 wk)) and second regimen subcutaneous since 18Dec2021 (ongoing) (Batch/Lot number: unknown) at 150 mg (150 mg (1 in 12 wk)) for psoriasis. Relevant medical history included: "Atrial fibrillation", start date: 1996 (unspecified if ongoing); "Non-Smoker" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing); "Insomnia" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS taken for atrial fibrillation; AMBIEN taken for insomnia. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EL3249, Expiration date: May2021), administration date: 15Feb2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "injection site pain"; Bnt162b2 (DOSE 2, SINGLE, Lot number EN9581, Expiration date: May2021), administration date: 09Mar2021, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "injection site pain". The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "He received 3rd dose COVID-19 Vaccine"; INJECTION SITE HAEMORRHAGE (non-serious) with onset 18Dec2021, outcome "recovered" (18Dec2021), described as "bleeding thumb"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Injection site pain"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 18Dec2021, outcome "recovered" (18Dec2021), INJURY ASSOCIATED WITH DEVICE (non-serious) with onset 18Dec2021, outcome "recovered" (18Dec2021) and all described as "the patient experienced needle stick injury"; ACCIDENTAL EXPOSURE TO PRODUCT (non-serious), EXPOSURE VIA SKIN CONTACT (non-serious) all with onset 18Dec2021, outcome "unknown" and all described as "not noticed green button, turned pen upside down/applied pressure/depressing white needle sleeve to thumb". The action taken for risankizumab was dosage not changed.  Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The patient had no known allergy. On 17Nov2021, the patient received the third dose COVID-19 Vaccine manufactured by Pfizer, lot number 3303080. The patient did not had the expiration date of the third COVID-19 vaccine because it was not written in the vaccination card. On 18Dec2021, the patient experienced needle stick injury/not noticed green button, turned pen upside down/applied pressure/depressing white needle sleeve to thumb/all medication squirted out/bleeding thumb. On 18Dec2021, the patient had issue with one risankizumba (SKYRIZI) pen. The patient checked the window before injection and it was clear. He removed gray cap. Pen was not dropped, cap was not twisted and was not recapped. He pinched his skin and placed the pen firmly at a 90 degree angle at the injection site. The patient did not notice the green button and turned the pen upside down. He applied pressure and depressing the white needle sleeve to his thumb until the green button was pressed. All medication squirted out and went everywhere according. yellow indicator was observed. The causality for events needle stick injury/not noticed green button, turned pen upside down/applied pressure/depressing white needle sleeve to thumb/all medication squirted out/bleeding thumb onset 18Dec2021 with risankizumba was not provided. The reporter's causality for the event of injection site pain after COVID-19 vaccine onset 17Nov2021 with risankizumba was no reasonable possibility.   The reporter considered "bleeding thumb" and "the patient experienced needle stick injury" not related to bnt162b2.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a role of role of the suspect product BNT162B2 to the development of events needle stick injury and  injection site hemorrhage was considered unrelated.