Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Device issue, Incorrect dose administered, Injection site haemorrhage
Clinical narrative: when pen removed Humira was spraying from pen mixed with blood/received the needle stick/after waiting for 30 seconds before lifting the pen medication just shut everywhere just a split second after lifting the pen f/recurrent blood on injection site; received the needle stick/after waiting for 30 seconds before lifting the pen medication just shut everywhere just a split second after lifting the pen from the injection site; hit the plum button no clicks/received the needle stick/medication just shut everywhere just a split second after lifting the pen from the injection site,; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (when pen removed Humira was spraying from pen mixed with blood/received the needle stick/after waiting for 30 seconds before lifting the pen medication just shut everywhere just a split second after lifting the pen f/recurrent blood on injection site), DEVICE ISSUE (received the needle stick/after waiting for 30 seconds before lifting the pen medication just shut everywhere just a split second after lifting the pen from the injection site) and INCORRECT DOSE ADMINISTERED (hit the plum button no clicks/received the needle stick/medication just shut everywhere just a split second after lifting the pen from the injection site,) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis, Penicillin allergy (Manifested by Joint swelling) since 1971, Non-smoker and Alcohol use (ONE TO A COUPLE OF DRINKS EVERY FEW WEEKS). Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for High cholesterol, MESALAZINE (LIALDA) for Ulcerative colitis.   On 17-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 30-Jun-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2022, the patient experienced DEVICE ISSUE (received the needle stick/after waiting for 30 seconds before lifting the pen medication just shut everywhere just a split second after lifting the pen from the injection site) and INCORRECT DOSE ADMINISTERED (hit the plum button no clicks/received the needle stick/medication just shut everywhere just a split second after lifting the pen from the injection site,). On an unknown date, the patient experienced INJECTION SITE HAEMORRHAGE (when pen removed Humira was spraying from pen mixed with blood/received the needle stick/after waiting for 30 seconds before lifting the pen medication just shut everywhere just a split second after lifting the pen f/recurrent blood on injection site). On 18-Feb-2022, INJECTION SITE HAEMORRHAGE (when pen removed Humira was spraying from pen mixed with blood/received the needle stick/after waiting for 30 seconds before lifting the pen medication just shut everywhere just a split second after lifting the pen f/recurrent blood on injection site) had resolved. At the time of the report, DEVICE ISSUE (received the needle stick/after waiting for 30 seconds before lifting the pen medication just shut everywhere just a split second after lifting the pen from the injection site) and INCORRECT DOSE ADMINISTERED (hit the plum button no clicks/received the needle stick/medication just shut everywhere just a split second after lifting the pen from the injection site,) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 vaccine trial. On unknown dates, when pen removed Humira was spraying from pen mixed with blood and there was recurrent blood on injection site. On 18 -Feb-2022, the patient hit the plum button no clicks/received the needle stick/medication just shut everywhere just a split second after lifting the pen from the injection site and received the needle stick/after waiting for 30 seconds before lifting the pen medication just shut everywhere just a split second after lifting the pen from the injection site.  The reporter's causality for the event(s) of when pen removed Humira was spraying from pen mixed with blood with Humira 40mg/0.4ml (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of hit the plum button no clicks/received the needle stick/medication just shut everywhere just a split second after lifting the pen from the injection site and received the needle stick/after waiting for 30 seconds before lifting the pen medication just shut everywhere just a split second after lifting the pen from the injection site was not provided. The reporter's causality for the event(s) of recurrent blood on injection site with Humira 40mg/0.4ml (adalimumab) was a reasonable possibility. The reporter assessed event recurrent blood on injection site and device issue as possibly related to PFIZER BIONTECH COVID-19 vaccine and MODERNA COVID-19 VACCINE.  No treatment details were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.