Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Crohn's disease, Drug ineffective, Extra dose administered, Fatigue
Clinical narrative: Crohn's aggravated; patient received booster dose COVID-19 Vaccine manufactured by Pfizer; patient received booster dose COVID-19 Vaccine manufactured by Pfizer; Headache; Worn out; Vaccination failure; Vaccination failure; This is a solicited report from a FACILITATED COLLECT based on information received by Pfizer from AbbVie, manufacturer control number: 21K-163-4078275-00. A non-contactable consumer (patient) reported that a 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 60-years-old), dose 4 intramuscular on 09Sep2021 (Batch/Lot number was not reported) as DOSE 4, SINGLE; dose 3 intramuscular on 20Aug2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE; dose 2 via intramuscular on 13Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE and dose 1 intramuscular on 23Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation; and adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to 07Aug2021, at unspecified dose for moderate to severe Adult Crohn's Disease. Medical history included moderate to severe adult crohn's disease. The patient's concomitant medications were not reported. The patient experienced Vaccination failure in 2021; Crohn's aggravated in Sep2021; Headache and Worn out in 2021. This solicited report by a consumer of a 60-year-old male with events of non-serious major Crohn's flare up after Covid vaccine, no detachable immune response to covid vaccine, headache after covid vaccine and felt worn out after two doses of covid vaccine with Humira (Adalimumab). In 2021, the patient experienced no detachable immune response to covid vaccine, headache after covid vaccine and felt worn out after two doses of covid vaccine. In September 2021, the patient experienced major Crohn's flare up after Covid vaccine. Pfizer-BioNTech Covid-19 Vaccine was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 23Mar2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 13Apr2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. On 20Aug2021, patient received booster dose COVID-19 Vaccine manufactured by Pfizer. On 09Sep2021, patient received booster dose COVID-19 Vaccine manufactured by Pfizer. The patient underwent lab tests and procedures which included Lab test: No detectable immune response on an unspecified date. The action taken in response to the events with adalimumab was temporarily withdrawn. The outcome of the events was unknown.  Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of major Crohn's flare up after Covid vaccine, no detachable immune response to covid vaccine, headache after covid vaccine and felt worn out after two doses of covid vaccine with Humira (Adalimumab) was no reasonable possibility.   The reporter's causality for the events of Crohn's aggravated, Vaccination failure, headache and worn out after two doses of covid vaccine with Pfizer-BioNTech Covid-19 Vaccine was Possible.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug Ineffective, COVID-19, Headache, Fatigue, Off Label use, Extra dose administered and the suspect drug BNT162B2 cannot be excluded. The event of Crohn's disease aggravated is unrelated to the suspect drug BNT162B2 considering possible contributory effects from patient's medical history 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.