Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Colon operation, Diarrhoea, Dizziness, Dyspnoea exertional, Fatigue
Clinical narrative: 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 (RA). A 50-year-old female patient received BNT162b2 (BNT162B2), on 10Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years 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); "Sjogren's syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1, Route of administration: Intramuscular), administration date: 30Mar2021, when the patient was 50-year-old, for Covid-19 vaccination; BNT162b2 (Dose: 2, Route of administration: Intramuscular), administration date: 27Apr2021, when the patient was 50-year-old, for Covid-19 vaccination. The following information was reported: SPINAL FRACTURE (medically significant), outcome "recovering", described as "fractures in back"; COLON OPERATION (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"; FATIGUE (medically significant), outcome "unknown", described as "fatigue/exhaustion"; 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"; 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"; SKIN DISORDER (non-serious), outcome "unknown", described as "had spots that looked like hives on her face, arms and eyebrow on the side where she was injected". The patient underwent the following laboratory tests and procedures: Heart rate: (unspecified date) elevated; Weight: (20Jun2021) 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) Her normal was between 100 and 115 pounds, notes: Her normal was between 100 and 115 pounds; (unspecified date) got up to 180, notes: She was down to 80 pounds and she got up to 180 pounds. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of colon operation. The reporter considered "flu like symptoms", "bruise at injection site" and "had spots that looked like hives on her face, arms and eyebrow on the side where she was injected" related to BNT162b2. Clinical course: Solicited report by a consumer of an adult female with events of emergency colon surgery and non-serious multiple compression in left foot and lower back due to weight gain, flu like symptoms, diarrhea, dizziness, elevated pulse when sitting up or standing, fatigue/winded and experiences exhaustion doing minor activities, migraines, osteoporosis, Humira injection made sick, Covid vaccine caused bruise at injection site, spots looked like hives on face, arms and eyebrows on side where Covid vaccine was injected, fractures in back were healing very slowly and patient was down to 80 pounds with Humira (Adalimumab). The patient had a relevant medical history of full body complex regional pain syndrome. On unknown dates, the patient experienced emergency colon surgery, multiple compression in left foot and lower back due to weight gain, flu like symptoms, diarrhea, dizziness, elevated pulse when sitting up or standing, fatigue/winded and experiences exhaustion doing minor activities, migraines, osteoporosis, Humira injection made sick, Covid vaccine caused bruise at injection site, spots looked like hives on face, arms and eyebrows on side where Covid vaccine was injected, fractures in back were healing very slowly and patient was down to 80 pounds. Pfizer BioNTech Covid-19 vaccine (Tozinameran) was also considered suspect. The patient had emergency colon surgery. She had flu like symptoms, diarrhea, dizziness, migraine, elevated pulse when sitting or standing and fatigue. She was winded and experienced exhaustion doing minor activities. Had multiple compression in left foot and lower back due to weight gain. The fractures in her back were healed very slowly. Had osteoporosis and took injection that made her sick. On 20Jun2021, she was put on feeding tubes and gained weight. She was down to 80 pounds, and she got up to 180 pounds. She was now 169. Her normal was between 100 and 115 pounds. She had bruise at injection site with each vaccine. On 22Jan2022, she had spots that looked like hives on her face, arms and eyebrow on the side where she was injected. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Causality for Pfizer BioNTech Covid-19 Vaccine (tozinameran): The reporter's causality for the event(s) of Colon operation, Weight gain, Diarrhea, Dizziness, Pulse increased, Fatigue, Migraine, Osteoporosis, Sickness, Nerve compression, Spinal fracture, Weight loss, Healing delayed, Exertional dyspnoea was not reported. The reporter's causality for the event(s) of flu like symptoms, Vaccination site brushing, Skin disorder was possible. Causality for Humira (Adalimumab): The reporter's causality for the event(s) of emergency colon surgery, multiple compression in left foot and lower back due to weight gain unknown onset, multiple compression in left foot and lower back due to weight gain unknown onset, flu like symptoms, diarrhea, dizziness, elevated pulse when sitting up or standing, fatigue/winded and experiences exhaustion doing minor activities unknown onset, migraines, osteoporosis, Humira injection made sick, Covid vaccine caused bruise at injection site, spots looked like hives on face, arms and eyebrows on side where Covid vaccine was injected, fractures in back were healing very slowly unknown onset, patient was down to 80 pounds, fractures in back were healing very slowly unknown onset and fatigue/winded and experiences exhaustion doing minor activities unknown onset was not provided. Regulatory Authority opinion is that there is no reasonable possibility that the events of emergency colon surgery, multiple compression in left foot and lower back due to weight gain unknown onset, multiple compression in left foot and lower back due to weight gain unknown onset, osteoporosis, Exertional dyspnoea, Covid vaccine caused bruise at injection site, fractures in back were healing very slowly unknown onset, patient was down to 80 pounds and fatigue/winded and experiences exhaustion doing minor activities unknown onset are related to Humira (Adalimumab). Regulatory Authority opinion is that the events of flu like symptoms, diarrhea, dizziness, elevated pulse when sitting up or standing, fatigue/winded and experiences exhaustion doing minor activities unknown onset, migraines, Humira injection made sick, spots looked like hives on face, arms and eyebrows on side where Covid vaccine was injected and fractures in back were healing very slowly unknown onset are not assessable. 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 current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully 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.