Age: 38.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Crohn's disease, Malaise, Off label use, Product use issue
Clinical narrative: Been to ER a bunch of times due to crohn's related pain.; Inflectra (Infliximab) was given at 600 mg every 5-6 weeks for Crohn's/weight: 194lbs; Inflectra (Infliximab) was given at 600 mg every 5-6 weeks for Crohn's/weight: 194lbs; I got an inflectra infusion 3 days after my 1st vaccine dose and felt horrible for 2 days; The initial safety information received was reporting only non-serious adverse drug reaction, upon receipt of follow-up information on [16Apr2021], this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 38-year-old, via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; infliximab (INFLECTRA), via an unspecified route of administration from 25Feb2021 (Batch/Lot number was not reported) and ongoing, at 600 mg (600 mg every 5-6 weeks) for Crohn's. Medical history included partial blockage in 2018 and being immunosuppressed since 2003. Concomitant medications included paracetamol (TYLENOL) and diphenhydramine hydrochloride (BENADRYL). The patient previously took infliximab (REMICADE) for Crohn's from 2003 to an unspecified date. The patient reported that he was an immunosuppressed person who has received two doses of COVID 19 vaccine. He received dose 1 on 22Feb2021 and dose 2 on 15Mar2021. He also received an infusion of Inflectra on 25Feb2021. Prior to his 25Feb2021 infusion, he had received either Inflectra or Remicade infusions bi-monthly for over a decade. The patient stated that if he can participate in any study of the Covid vaccine's efficacy on immunosuppressed people, please let him know how he can help. The patient reported that he has been to ER a bunch of times due to Crohn's-related pain on an unspecified date. He got an Inflectra infusion 3 days after his 1st vaccine dose and felt horrible for 2 days. The patient was asking if getting an Inflectra infusion so closely to a 1st vaccine dose reduce his antibody production. The action taken in response to the events for infliximab was unknown. The outcome of the events was unknown.  Information on the lot/ batch number has been requested.  Follow-up (23Apr2021): This is a follow-up spontaneous report based on the information received by Pfizer. A contactable consumer (patient) reported that:  This follow-up serious report was received from other study by a consumer in on 16 Apr 2021.  This is a non-Celltrion sponsored study.  Added patient's age reported as 38 (unit not provided). Added patient's weight of 194 lbs and height of 5'8".  Previously reported event "I am an immunosuppressed person" (coded as Immunosuppression) was removed as an event and was added as historical condition which started on 2003 and reportedly that patient is fine now. It was further reported that patient was admitted to hospital due to being immunosuppressed. Added historical drug Remicade started on 2003 for Crohn's. On unspecified date, the patient experienced additional events described as "Been to ER a bunch of times due to Crohn's related pain" and "Admitted for partial blockage in 2018" (coded to unevaluable event) and "I got an Inflectra infusion 3 days after my 1st vaccine dose and felt horrible for 2 days" (coded to Feeling bad). Corrective treatment for the events and outcome of events were not reported. Added regimen for Inflectra (Infliximab) to include dose and frequency of 600 mg every 5-6 weeks and start date of 2021. Additional concomitant medications included Tylenol at 1g given before infusion and Benadryl at 25 mg given before infusion, both given via unspecified route for unspecified indication. Additional co-suspect drug BTN162B2 was added, for vaccination, 2 doses in Q1 2021, date started on Feb 2021. Additionally, event Overdose was captured as Inflectra (Infliximab) was given at 600 mg dose for Crohn's for patient with weight of 194 lbs. Event Off label dosing frequency was also captured as Inflectra (Infliximab) was given at 600 mg every 5-6 weeks for Crohn's. The reporter did not provide seriousness for event pain while serious (hospitalization) for event Admitted for partial blockage.  Reporter's causality for event pain was not related (reported as Crohn's-related pain) and causality was not reported for event Admitted for partial blockage. The reporter did not describe events overdose and off label use.  Case comment for follow-up dated 16 APR 2021: Updates to case details (additional events, historical drug) noted. Causality of event partial blockage-Unevaluable event (Unlisted, Serious) is Not assessable in the absence of necessary details for a meaningful assessment. Causality of event Feeling abnormal (Unlisted, Non-serious) is Related based on the temporal relationship between therapy and event. Known history of immunosuppression and recent vaccination are confounders to the assessment. Causality of event Pain (Listed, Non-serious) is Not related and attributed to the underlying condition. Causality of events Overdose and Off label dosing frequency (both Unlisted, Non-serious) is Not applicable and dependent on the prescribing practice of the HCP.