Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Medical device implantation; Abscess discharge; On 05Mar2021, he received 1st dose of COVID-19 Vaccine manufactured by Johnson and Johnson; On 05Mar2021, he received 1st dose of COVID-19 Vaccine manufactured by Johnson and Johnson; flu like symptoms; This is a solicited report received from contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. Other Case identifier: 22K-163-4226577-00 (AbbVie).  A 62-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Oct2021 (Batch/Lot number: unknown) at the age of 62 years as dose number unknown (booster), single for COVID-19 immunization; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) and second regimen subcutaneous (ongoing) (Batch/Lot number: unknown) for Crohn's disease. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Johnson and Johnson (On 05Mar2021, he received 1st dose of COVID-19 Vaccine manufactured by Johnson and Johnson), administration date: 05Mar2021, when the patient was 62 years old, for Covid-19 immunization. Solicited report by a consumer of a 62-year-old male with events of patch put in because of abscess and had leakage and non-serious flu like symptoms and patch put in because of abscess and had leakage with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced patch put in because of abscess and had leakage. In 2021, the patient experienced flu like symptoms. On an unknown date, flu like symptoms resolved. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. The patient said physician Implied changing his Humira. He had a colonoscopy in May or June and had a patch put in because of abscess. He wears a woman patch because had leakage and it was annoying also he was taking Humira once a week which was better. On 21Oct2021, he took the Booster Pfizer and had flu like symptoms which was gone. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 05Mar2021, he received 1st dose of COVID-19 Vaccine manufactured by Johnson and Johnson. On 21Oct2021, he received COVID-19 booster Vaccine manufactured by Pfizer/BioNTech. The patient underwent the following laboratory tests and procedures: colonoscopy: (2021) unknown result. The action taken for adalimumab was dosage not changed. Therapeutic measures were taken as a result of abscess. Outcome of Flu like symptoms was recovered, Abscess discharge was recovering, of the other events was unknown. The events are considered as serious (Other medically important condition).  Causality for Humira (Adalimumab): The reporter's causality for the events of Medical device implantation, Flu like symptoms was not provided. The reporter's causality for the event Abscess discharge with Humira (Adalimumab) was a reasonable possibility. Abbvie's opinion is that there is no reasonable possibility that all events are related to Humira (Adalimumab).  Causality for Pfizer Biontech Covid-19 Vaccine (Tozinameran): The reporter's causality for all events was Not Related for Pfizer Biontech Covid-19 Vaccine (Tozinameran).  No follow-up attempts are possible; Information about lot/batch cannot be obtained. No further information is expected.; Sender's Comments: Based on data given, the reported events are assessed as unrelated to suspect product.