Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Illness, Impaired healing, Influenza like illness
Clinical narrative: diarrhea; dizziness; elevated pulse when sitting up or standing; migraines; osteoporosis; humira injection made sick; bruise at injection site; patient was down to 80; fractures in back were healing very slowly; Exertional dyspnoea; experiences exhaustion doing minor activities; fractures in back; emergency colon surgery; flu like symptoms; multiple compression in left foot and lower back; weight gain; 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-163-4350468-00 (Company).  A 49-year-old female patient received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years and on 27Apr2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous for crohn's disease. The patient's relevant medical history included: "Full body complex regional pain syndrome" (unspecified if ongoing); "Gastroparesis" (unspecified if ongoing); "Sjoegren's syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: WEIGHT INCREASED (medically significant) with onset 20Jun2021, outcome "unknown", described as "weight gain"; SPINAL FRACTURE (medically significant), outcome "recovering", described as "fractures in back"; COLON INJURY (medically significant), outcome "unknown", described as "emergency colon surgery"; INFLUENZA LIKE ILLNESS (medically significant), outcome "unknown", described as "flu like symptoms"; NERVE COMPRESSION (medically significant), outcome "unknown", described as "multiple compression in left foot and lower back"; DIARRHOEA (medically significant), outcome "unknown", described as "diarrhea"; DIZZINESS (medically significant), outcome "unknown"; HEART RATE INCREASED (medically significant), outcome "unknown", described as "elevated pulse when sitting up or standing"; MIGRAINE (medically significant), outcome "unknown", described as "migraines"; OSTEOPOROSIS (medically significant), outcome "unknown"; ILLNESS (medically significant), outcome "unknown", described as "humira injection made sick"; VACCINATION SITE BRUISING (medically significant), outcome "unknown", described as "bruise at injection site"; WEIGHT DECREASED (medically significant), outcome "unknown", described as "patient was down to 80"; IMPAIRED HEALING (medically significant), outcome "unknown", described as "fractures in back were healing very slowly"; DYSPNOEA EXERTIONAL (medically significant), outcome "unknown", described as "Exertional dyspnoea"; FATIGUE (medically significant), outcome "unknown", described as "experiences exhaustion doing minor activities". The patient underwent the following laboratory tests and procedures: Heart rate: (unspecified date) elevated; Weight: (20Jun2022) gained weight, notes: On 20Jun2021, she was put on feeding tubes and gained weight; Weight: (unspecified date) down to 80, notes: She was down to 80 pounds and she got up to 180 pounds; (unspecified date) got up to 180, notes: She was down to 80 pounds and she got up to 180 pounds; (unspecified date) Her normal was between 100 and 115, notes: Her normal was between 100 and 115 pounds. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of colon injury.  The reporter's assessment of the causal relationship of "fractures in back", "emergency colon surgery", "flu like symptoms", "multiple compression in left foot and lower back", "weight gain", "diarrhea", "dizziness", "elevated pulse when sitting up or standing", "migraines", "osteoporosis", "humira injection made sick", "bruise at injection site", "patient was down to 80", "fractures in back were healing very slowly", "exertional dyspnoea" and "experiences exhaustion doing minor activities" 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.  No follow-up attempts are possible; 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 reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.