Sex: F
Vaccine: COVID19, COVID19
Symptoms: Crohn's disease, Headache, Joint range of motion decreased, Pyrexia, Therapeutic product effect incomplete
Clinical narrative: head hurt/could not touch or turn head after first shot of the vaccination; Fever; was in bad shape for the Crohn's after the vaccination; took vaccination then got sick; head hurt/could not touch or turn head after first shot of the vaccination onset; Humira did not work well; This is a solicited report received from a contactable consumer (patient) based on the information received by Pfizer (Mfr. Control No. :21K-163-4071089-00).  Solicited report by a consumer of a 71 year old female with events of took vaccination then got sick, head hurt/could not touch or turn head after first shot of the vaccination, was in bad shape for the Crohn's after the vaccination and fever and non-serious Humira did not work well with Humira (Adalimumab). There was no reported medical history. On an unknown date, the patient experienced Humira did not work well. In Aug2021, the patient experienced took vaccination then got sick, head hurt/could not touch or turn head after first shot of the vaccination, was in bad shape for the Crohns after the vaccination and fever. In 2021, the took vaccination then got sick, head hurt/could not touch or turn head after first shot of the vaccination, was in bad shape for the Crohns after the vaccination and fever resolved. On an unknown date, Humira did not work well resolved. Pfizer Biontech Covid-19 Vaccine (Tozinameran) was also considered suspect. In Aug2021, the patient had severe symptoms from the Pfizer vaccination. She took vaccination then got sick had to go into the hospital, fever, head hurt. She could not touch or turn the head after the first shot of the vaccination and had to stay in the hospital for three days then four days after that had to go back to the hospital for four days. Later she was in the hospital and stated she was in bad shape for the Crohns after the vaccination. The physician stated they might have to increase the dosage of the HUMIRA injection due to Humira not working well. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. In Aug2021 she received first dose of COVID-19 Vaccine manufactured by Pfizer. Primary reporter contact for lot number information was unsuccessful.   Causality for Humira (Adalimumab): The reporter's causality for the events of took vaccination then got sick, head hurt/could not touch or turn head after first shot of the vaccination onset in Aug2021, head hurt/could not touch or turn head after first shot of the vaccination onset in Aug2021, was in bad shape for the Crohn's after the vaccination, Fever and Humira did not work well was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of took vaccination then got sick, head hurt/could not touch or turn head after first shot of the vaccination onset in Aug2021, head hurt/could not touch or turn head after first shot of the vaccination onset in Aug2021, was in bad shape for the Crohns after the vaccination, fever and Humira did not work well are related to Humira (Adalimumab). Causality for PFIZER BIONTECH COVID-19 Vaccine (tozinameran): The reporter's causality for the events of took vaccination then got sick, head hurt/could not touch or turn head after first shot of the vaccination onset in Aug2021, head hurt/could not touch or turn head after first shot of the vaccination onset in Aug2021, was in bad shape for the Crohn's after the vaccination and fever was possible, for the event Humira did not work well was not provided.  The reporter's assessment of the causal relationship of the event "Humira did not work well" with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events Headache Pyrexia, Chrohn's disease, Vaccination complication, Joint range of motion decreased and Theraupatic product effect incomplete 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. 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.