Age: 49.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Crohn's disease, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: Crohn's disease aggravated; Chills; Feeling sick; Feeling abnormal; Low grade fever; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Agency (MFR no.: 20K-163-3635566-00).  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Feb2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation;  and CROHN'S DISEASE FLARE UP with HUMIRA (ADALIMUMAB). There was no reported medical history. Concomitant medication(s) included: FLU taken for immunisation, start date: Nov2021, stop date: Nov2021. On unknown dates, the patient experienced CHILLS and CROHN'S DISEASE FLARE UP. COVID-19 VACCINE was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On an unknown date, patient received 1st dose COVID-19 Vaccine manufactured by unknown, lot number unknown, expiration date unknown. First COVID-19 vaccine caused her to go into a Crohn's flare, diarrhea for a couple days, chills. On 25Feb2021, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The events of "CHILLS" and "CROHN'S DISEASE FLARE UP"  were added. In 2021, the patient experienced felt sick, felt a little out of sorts and low grade fever. On unknown dates, felt sick, felt a little out of sorts and low grade fever resolved. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. In Feb2021, she received first dose of COVID-19 Vaccine manufactured by Pfizer/BioNTech. In Feb2021, she received second dose of COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 30Dec2021, she received booster dose of COVID-19 Vaccine manufactured by Pfizer/BioNTech.  Amendment to data received on 25Feb2021 with changes to event information, reporter opinion of causality and narrative description. The event of "DIARRHEA TWO TIMES" was removed.  Causality for HUMIRA (ADALIMUMAB)   The reporter's causality for the event(s) of CHILLS and CROHN'S DISEASE FLARE UP was not provided. 1) Chills, Causality as per reporter (Drug/Vaccine): Not Reported  2) Crohn's disease aggravated, Causality as per reporter (Drug/Vaccine) : Not Reported  3) The reporter's causality for the event(s) of felt sick, felt a little out of sorts and low grade fever was not provided.  Causality for COVID-19 Vaccine (COVID-19 Vaccine) 1) Chills, Causality as per reporter (Drug/Vaccine): Not Reported  2) Crohn's disease aggravated, Causality as per reporter (Drug/Vaccine): Not Reported 3) The reporter's causality for the event(s) of felt sick, felt a little out of sorts and low grade fever was Probable.  The reporter's assessment of the causal relationship of Crohn's disease aggravated and chills with the suspect product 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.  Report Source: Study Report Type: Follow Up  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (19Jan2022): This is a solicited follow-up report based on information received by Pfizer from Agency (MFR no.: 20K-163-3635566-00). Same contactable consumer reported that:  Updated Information Included: Reporter Information (reporter slide #01 name added PC checked VAERS field updated, slider#02 email address added), Concomitant drug added. Dosage Regimens (start date, stop date, dose description), Event information (new event added, outcome)  No Follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events chills, malaise, feeling abnormal, and pyrexia and BNT162B2. The Company considers the reported event Crohn's disease aggravated is unrelated to COVID-19 vaccine but more likely due to underlying or an inter-current medical condition.