Sex: F
Vaccine: COVID19, UNK
Symptoms: Bronchitis, COVID-19, Crohn's disease, Drug ineffective, Dyspnoea
Clinical narrative: Trouble with breathing; Patient was being in hospital in Aug2021 for Covid; Patient was being in hospital in Aug2021 for Covid; Pneumonia; Acute bronchitis; Crohns disease aggravated; Lost weight; This is a solicited report from the marketing program facilitated collect received from a contactable consumer (patient) based on the information received by Pfizer from AbbVie manufacture number (21K-163-4123872-00).  A 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) intramuscular on an unspecified date in 2021 as dose number unknown, single for COVID-19 immunization; and adalimumab (HUMIRA, Solution for injection in pre-filled pen, lot number and expiry date not reported), subcutaneous from an unspecified date in 2021 to an unspecified date, at an unknown dose and frequency and from an unspecified date in Oct2021 to an unspecified date for moderate to severe adult crohn's disease. The patient's medical history not reported. The concomitant medication included Oxygen on an unknown date for unspecified indication. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date in 2021, the patient experienced pneumonia, acute bronchitis and had been in hospital and tested positive for covid on 27Aug2021. The patient had acute bronchitis was admitted to the hospital with pneumonia was on oxygen. On 21Sep2021, she was discharged from hospital then transferred to rehab for three weeks. For about six weeks she was off Humira and on 12Oct2021 she was back on humira. On 15Oct2021 had trouble with breathing. then was transferred and returned home but as of 15Oct2021 had trouble with breathing and was experienced crohns disease aggravated and lost weight on an unspecified date. The patient underwent lab tests and procedures were included COVID-10 test positive on 27Aug2021 and loss weight 20 lbs. The outcome of the event COVID, pneumonia and acute bronchitis was recovering while for the event trouble with breathing and Lost weight was unknown and event crohns disease aggravated was not recovered at the time of report.  Solicited report from the by a consumer of a 67 year old female with an event of COVID with HUMIRA (ADALIMUMAB). There was no reported medical history. In 2021, the patient experienced COVID. PFIZER BIONTECH COVID-19 VACCINE (TOZINAM-ERAN) was also considered suspect. The patient was being in hospital in Aug2021 for Covid, then transferred to rehab. She returned home but as of 15Oct2021 had trouble with breathing It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received COVID-19 Vaccine manufactured by Pfizer/BionTech.  Causality for Humira (Adalimumab):  The reporters causality for the event(s) of covid, pneumonia, lost 20 lbs, acute bronchitis and flare ups with crohns disease was not provided. AbbVies opinion is that there is no reasonable possibility that the events of covid, pneumonia, lost 20 lbs, acute bronchitis and flare ups with crohns disease are related to Humira(Adalimumab). Causality for Humira (Adalimumab)  For suspect drug Humira and the event COVID, the causality as per reporter (drug/vaccine) was not reported while per manufacturer was no reasonable possibility. For suspect drug Pfizer biontech covid-19 vaccine(tozinameran)(tozinameran) and the event COVID, the causality as per reporter was possible and Pneumonia, Lost weight, Acute bronchitis, Crohns disease aggravated was not reported     The reporter's assessment of the causal relationship of the events COVID and trouble with breathing 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.  Seq.No: 3 Humira (Solution for injection in pre-filled pen)(Adalimumab) Oct2021-Unk  COVID-19 the causality as per reporter was Reasonable possibility, Lost weight and Pneumonia: Causality as per reporter was Not reported : Causality as per Mfr was No reasonable possibility, Acute bronchitis and Crohns disease aggravated: Causality as per reporter was Reasonable possibility: causality as per Mfr was no reasonable possibility  Follow-up (21Nov2021): This is a follow-up solicited report from a contactable consumer (patient) based on the information received by Pfizer from AbbVie manufacture number (21K-163-4123872-00). Updated information: New event added and outcome was updated, co-suspect information added, causality updated, concomitant medication lab data added and other clinical information.  No follow-up attempts are possible, information about lot/batch number not available. No further information is expected.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case.The possibility of occurrence of COVID-19, Drug Ineffective, dyspnoea, hypoxia,Lost weight,  Pneumonia ,Acute bronchitis and Crohns disease aggravated cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out.  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.