Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Spinal stenosis
Clinical narrative: Patient was not sleeping well due to spinal stenosis; not sleeping well; Itching on legs/ankles/toes; On 2022, the patient experienced pain; In hospital for one day but may be due to sugar level; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4483525-00.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1160362) at 0.4 mL (0.4 ml (citrate free)), subcutaneous for psoriasis. The patient's relevant medical history included: "Blood pressure study/not in control", start date: 2020 (ongoing), notes: Sugar level: Unknown. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Intramuscular), for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, Intramuscular), for COVID-19 immunization. The following information was reported: BLOOD GLUCOSE ABNORMAL (prolonged hospitalization) with onset 2022, outcome "unknown", described as "In hospital for one day but may be due to sugar level"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "On 2022, the patient experienced pain"; SPINAL STENOSIS (prolonged hospitalization), outcome "not recovered", described as "Patient was not sleeping well due to spinal stenosis"; POOR QUALITY SLEEP (non-serious), outcome "not recovered", described as "not sleeping well"; PRURITUS (non-serious), outcome "recovering", described as "Itching on legs/ankles/toes". The patient underwent the following laboratory tests and procedures: Blood glucose: (2022) Unknown Results; SARS-CoV-2 test: (01Jul2022) Positive. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of spinal stenosis, pain.  Solicited report by a consumer of a 68.000 years old female with events of Spinal Stenosis, and In hospital for one day but may be due to sugar level, and non-serious covid, not sleeping well, Itching on legs/ankles/toes and Pain with Single Dose Pen, Adalimumab Solution for Injection. The patient had a relevant medical history of Blood pressure study/not in control. On 2022, the patient experienced covid. On 2022, the patient experienced pain. On 2022, the patient experienced in hospital for one day but may be due to sugar level. On unknown date(s), the patient experienced Itching on legs/ankles/toes, not sleeping well, spinal stenosis. On 2022, covid recovered/resolved. Pfizer Biontech Covid-19 Vaccine was also considered suspect. It was unknown if patient was enrolled in a Covid-19 vaccine trial. Patient was not sleeping well due to spinal stenosis and had back surgery done on 30Aug2022. She was still in pain but that was due to surgery. She stayed in hospital for one day but may have been due to sugar level. Takes pain medications as needed. Skin was healing nicely. Started physiotherapy and physiotherapist said legs were good and still using walker. Itching on legs/ankles/toes may be due to anesthesia from surgery or psoriasis. Treatment Drugs: The patient was treated with mucinex. Causalities: The reporter's causality for the event(s) of Itching on legs/ankles/toes with Adalimumab Solution for Injection was Reasonable Possibility. The reporter's causality for the event(s) of not sleeping well, spinal stenosis and covid with Adalimumab Solution for Injection was No Reasonable Possibility. The reporter's causality for the event(s) of not sleeping well, spinal stenosis, covid, Pain, In hospital for one day but may be due to sugar level and Itching on legs/ankles/toes with Pfizer BioNTech Covid-19 vaccine (Tozinameran) was not provided. The reporter's causality for the event(s) of Pain and in hospital for one day but may be due to sugar level with Adalimumab Solution for Injection was not provided. Opinion was that the causality for the event(s) of not sleeping well, spinal stenosis, covid, Pain, in hospital for one day but may be due to sugar level and Itching on legs/ankles/toes with Adalimumab Solution for Injection was no reasonable possibility. Etiology for spinal stenosis with adalimumab solution for injection: More likely related to increased risk from elderly age of patient. Etiology for Covid with adalimumab solution for injection: Event more likely related to SARS COV 2 pandemic outbreak in this elderly age patient with psoriasis. Etiology for in hospital for one day but may be due to sugar level with adalimumab solution for injection: More likely related to increased risk from elderly age patient with psoriasis confounded by covid infection. Etiology for Itching on legs/ankles/toes with adalimumab solution for injection: More likely related to underlying psoriasis and anesthesia. Etiology for not sleeping well with adalimumab solution for injection: More likely related to back pain due to spinal stenosis and itching from psoriasis. Etiology for Pain with adalimumab solution for injection: More likely related to surgery for spinal stenosis. Check All Appropriate To Adverse Reaction: Prolonged Inpatient Hospitalisation. Assessment Results: Humira 40mg/0.4ml - Localized itching, Non-Health Care Professional, Probable. Humira 40mg/0.4ml - Spinal stenosis, No Reasonable Possibility. Humira 40mg/0.4ml - Spinal stenosis, Non-Health Care Professional, Not Related. Humira 40mg/0.4ml - Covid-19, No Reasonable Possibility. Humira 40mg/0.4ml - covid-19, Non-Health Care Professional Not Related. Humira 40mg/0.4ml - Sleep unwell, Non-Health Care Professional, Not Related. Pfizer Biontech Covid-19 Vaccine - Spinal stenosis, Non-Health Care Professional, Not Reported. Humira 40mg/0.4ml - Blood sugar abnormal, No Reasonable Possibility. Humira 40mg/0.4ml - Blood sugar abnormal, Non-Health Care Professional, Not Reported. Pfizer Biontech Covid-19 Vaccine - Blood sugar abnormal, Non-Health Care Professional, Not Reported. Humira 40mg/0.4ml - Localized itching, No Reasonable Possibility. Pfizer Biontech Covid-19 Vaccine - Covid-19, Non-Health Care Professional, Not Reported. Pfizer Biontech Covid-19 Vaccine - Localized itching, Non-Health Care Professional, Not Reported. Pfizer Biontech Covid-19 Vaccine - Sleep unwell, Non-Health Care Professional, Not Reported. Humira 40mg/0.4ml - Sleep unwell, No Reasonable Possibility. Pfizer Biontech Covid-19 Vaccine - Pain, Non-Health Care Professional, Not Reported. Humira 40mg/0.4ml - Pain, No Reasonable Possibility. Humira 40mg/0.4ml - Pain, Non-Health Care Professional, Not Reported.  The reporter's assessment of the causal relationship of "patient was not sleeping well due to spinal stenosis", "in hospital for one day but may be due to sugar level", "not sleeping well", "itching on legs/ankles/toes" and "on 2022, the patient experienced pain" with the suspect product(s) BNT162b2, BNT162b2 omi ba.4-5 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.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.  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.