Sex: F
Vaccine: COVID19
Symptoms: Cervical spinal stenosis, Diarrhoea, Vaccination site erythema, Vaccination site nodule
Clinical narrative: cervical spinal stenosis; Vaccination site nodule; Vaccination site erythema; diarrhea; 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-163-4377763-00 (AbbVie).  A 61-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for crohn's disease. The patient's relevant medical history included: "Cervical spinal stenosis" (unspecified if ongoing); "surgery" (unspecified if ongoing), notes: in Jan and was in the hospital. The patient's concomitant medications were not reported. The following information was reported: CERVICAL SPINAL STENOSIS (hospitalization, medically significant) with onset Jan2022, outcome "recovered" (2022); VACCINATION SITE NODULE (non-serious), outcome "recovered"; VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered"; DIARRHOEA (non-serious), outcome "recovered", described as "diarrhea". The patient was hospitalized for cervical spinal stenosis (start date: Jan2022, discharge date: 2022). The action taken for adalimumab was unknown.  Clinical course: On unknown dates, the patient experienced cervical spinal stenosis and red knot on arm and diarrhea after covid second booster vaccine. The patient had cervical spinal stenosis which was predate of humira therapy and undergone surgery in Jan and was in the hospital. Patient was on an unspecified stimulator to heal. Patient did not agreed to contact physician. It was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter declined to be contacted. Causality for humira(adalimumab): The reporter's causality for the event(s) of cervical spinal stenosis, red knot on arm and diarrhea after covid second booster vaccine unknown onset, red knot on arm and diarrhea after covid second booster vaccine unknown onset and red knot on arm and diarrhea after covid second booster vaccine unknown onset with humira(adalimumab) was no reasonable possibility. Abbvie's opinion is that there is no reasonable possibility that the events of cervical spinal stenosis, red knot on arm and diarrhea after covid second booster vaccine unknown onset, red knot on arm and diarrhea after covid second booster vaccine unknown onset and red knot on arm and diarrhea after covid second booster vaccine unknown onset are related to humira(adalimumab). The Causality as per the reporter was "not related" and manufacturer with "no reasonable possibility" for Humira was reported for all events. The reporter considered "cervical spinal stenosis", "vaccination site nodule", "vaccination site erythema" and "diarrhea" related (probable) to BNT162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per limited available information, the causal relationship between the events "cervical spinal stenosis", "vaccination site nodule", "vaccination site erythema" and "diarrhea" and the suspected drug cannot be excluded. The case will be reassessed once new information is available.