Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Back pain, Blood test, Cervical radiculopathy, Hypothyroidism
Clinical narrative: redness at injection site/recurring injection site red spot; itching at injection site/recurring injection site itching; low energy; Psoriasis break out; Hypothyroidism; Compressed Back Nerve and Nerve Inflammation; Compressed Back Nerve and Nerve Inflammation; back pain worsened; This is a solicited report based on the information received by Pfizer (Mfr. Control No.: 21K-163-3972313-00). A contactable consumer (patient) reported for herself that a 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 29Mar2021 (Batch/Lot Number: ER8732) and dose 2 intramuscular on 19Apr2021 (Batch/Lot Number: EW0170); both as single dose for covid-19 immunization at age of 73 years old; adalimumab (HUMIRA, Solution for injection in pre-filled pen, 40 mg/0.4 ml), subcutaneous from Jan2021 and ongoing, at unknown dose CF (1 in 2 week) for moderate to severe chronic plaque psoriasis. Medical history included diverticulitis, patient mentioned that she had a history of diverticulitis and had a surgery to remove a part of her colon several years ago and five years ago she also underwent removal of hernia, seasonal allergy manifested by sinus problem, lisinopril allergy manifested by rashes, ongoing back pain, non-smoker, abstains from alcohol, high blood pressure, constipation, urinary tract infection, overactive bladder, indigestion, allergies, sinusitis, and unsteady hand when injecting in Jan2021 and ongoing. Concomitant medications included alendronate sodium to prevent osteoporosis; hydrochlorothiazide, losartan potassium (LOSARTAN HYDROCHLOROTHIAZIDE) taken for high blood pressure; atenolol taken for high blood pressure; linaclotide (LINZESS) taken for constipation; trimethoprim taken for urinary tract infection; trospium chloride taken for overactive bladder; omeprazole taken for indigestion; levocetirizine hydrochloride (LEVOCETIRIZINE) taken for allergies; montelukast sodium taken for allergies; fluticasone propionate (FLUTICASONE) taken for sinusitis; colecalciferol (VITAMIN D3) taken for supplement; calcium citrate taken for supplement; ascorbic acid, vaccinium macrocarpon (CRANBERRY) taken for supplement. On unknown dates, the patient experienced redness at injection site after took COVID vaccine, itching at injection site after took COVID vaccine and low energy. In Mar2021, the patient experienced back pain worsened. In Apr2021, the patient experienced recurring injection site red spot and recurring injection site itching. On 20Apr2021, the patient experienced compressed back nerve and nerve inflammation. On 28Jun2021, the patient experienced hypothyroidism. On 05Aug2021, the patient experienced medication administered unsuccessful and product quality issue (considered not related to bnt162b2). On 06Aug2021, the patient experienced psoriasis break out. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with Levothyroxine and Cortisone. The patient underwent lab tests and procedures which included unspecified blood test: unknown results in jun2021, magnetic resonance imaging: unknown results on 20apr2021. The action taken in response to the events for adalimumab was unknown. The outcome of low energy and psoriasis break out was resolving, outcome of other events was not resolved.  Causality for Adalimumab: The reporter's causality for the events of redness at injection site after took COVID vaccine, itching at injection site after took COVID vaccine, recurring injection site red spot and recurring injection site itching with Adalimumab was a reasonable possibility. The reporter's causality for the events of unsteady hand when injecting, compressed back nerve and nerve inflammation, hypothyroidism, low energy, psoriasis break-out and back pain worsened with Adalimumab was no reasonable possibility. The reporter's causality for the events of medication administered unsuccessful and product quality issue with Adalimumab was not provided. Causality for bnt162b2: The reporter's causality for the events of low energy, back pain worsened, compressed back nerve and nerve inflammation, hypothyroidism, medication administered unsuccessful and product quality issue, psoriasis break out with bnt162b2 was not related. The reporter's causality for the events of redness at injection site after took COVID vaccine, itching at injection site after took COVID vaccine with bnt162b2 was not provided. The reporter's causality for the events of recurring injection site red spot and recurring injection site itching with bnt162b2 was probable.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the reported information ,a causal relationship between the event hypothyroidism and suspected drug cannot be 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