Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease, Eye operation, Haemorrhoids
Clinical narrative: Crohn's disease; Eye operation; Hemorrhoids; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4405673-00.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), on 18Mar2021 as dose 2, single (Batch/Lot number: unknown), on 23Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 16May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as cf (Batch/Lot number: unknown) subcutaneous for crohn's disease; tigecycline (TIGECYCLINE), (Batch/Lot number: unknown). The patient's relevant medical history included: "COVID-19", start date: Nov2019 (unspecified if ongoing), notes: In Nov2019 the patient experienced covid. The patient's concomitant medications were not reported.  The patient stated that strong Antibiotic therapy that was Tygacil cused her Crohn's disease. she had been off Humira  for three  weeks due to eye surgery on right eye , left eye yet to be done. she had two covid vaccine and two booster shots , all Pfizer and most recent booster was 16May2022. She had a hemorrhoid that burned when she goes poop. She had no signs or symtoms of crohn's right now in 2022. it was unknown if patient  was enrolled in a covid-19 Vaccine trail. The following information was reported: CROHN'S DISEASE (medically significant), outcome "recovering"; EYE OPERATION (medically significant), outcome "recovering"; HAEMORRHOIDS (medically significant), outcome "recovering", described as "Hemorrhoids". The action taken for tigecycline was unknown. The action taken for adalimumab was dosage permanently withdrawn. Therapeutic measures were taken as a result of eye operation. The event abated after stopping drug.  The reporter's assessment of the causal relationship of "crohn's disease", "eye operation" and "hemorrhoids" with the suspect product(s) 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.   Causality for Humira (Adalimumab). The reporter's causality for the event(s) of right eye surgery, hemorrhoids, crohn's disease and covid was not provided. MFR opinion is that there is no reasonable possibility that the events of RIGHT EYE surgery, hemorrhoids, Crohn's disease and covid are related to humira(adalimumab).  Suspect Drug(S) Information: Suspect Drug(S) (include generic name)  Seq. No: 1 Drug: HUMIRA(Solution for injection in pre-filled  syringe)(ADALIMUMAB),UNKNOWN Daily Dose: CF Route of Administration: Moderate To Severe Adult Crohn's Disease Indications for Use: Subcutaneous Therapy Dates(From/To): UNK  Causality 1) Eye operation  (Eye operation) Action(s) taken with drug: Drug discontinued  Causality as per reporter (Drug/Vaccine): Not Repotted  Causality as per MFR(Drug/Vaccine): No reasonable possibility Dechallenge: yes  2)Hemorrhoids (Haemorrhoids) Action(s) taken with drug :Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per MFR(Drug/Vaccine): No reasonable possibility Dechallenge : N/A  3)Crohn's disease  (Crohn's disease)  Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per MFR(Drug/Vaccine): No reasonable possibility Dechallenge : N/A  4) COVID-19  (COVID-19) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Causality as per MFR(Drug/Vaccine): No reasonable possibility Dechallenge: N/A  Seq.No: 2 Drug: Tygacil (Tigecycline)(Tigecycline),Unknown Route of Administration: Unknown Indications for Use: unknown indication  Causality Eye operation  (Eye operation) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not Reported Dechallenge : N/A  2) Hemorrhoids  (Haemorrhoids) Action(s) taken with drug  :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge : N/A  3) Crohn's disease  (Crohn's disease) Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) : Probable Dechallenge  : N/A  4) COVID-19  (COVID-19) Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) :  Not Reported Dechallenge :  N/A   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 information provided in the narrative, a causal association between the suspect drug and the events cannot be completely 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.