Age: 43.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anaemia, Blood test, Laboratory test, Laboratory test abnormal, Menstrual disorder
Clinical narrative: Worsened anemia; Abnormal lab values; Injection site Itchiness; Injection site raised or inflamed bump; Injection site bruising, itching, redness after receiving; Worsened menstrual symptoms; Vaccination site erythema; Injection site raised or inflamed bump; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer, manufacturer control number:21K-163-4134022-00). A contactable 43-year-old female consumer (patient) reported for herself that:  A 43-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 10Mar2021 (Lot Number: EN6207) as DOSE 1, SINGLE, dose 2 intramuscular on 31Mar2021 (Lot Number: ER8732) as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2021 (Batch/Lot number was not reported) and ongoing, at 40 mg for psoriatic arthropathy. Patient Medical History: Abstains From Alcohol (Started 1998), Iron Saturation Was Eight Percent (Started 06Aug2020), Fibromyalgia, Consistent Problems With Feet, Migraines, Tension Head Aches, Temporomandibular Joint Dysfunction, Chronic Fatigue Syndrome, Myofascial Pain, Pain Syndrome, Mild Psoriasis, Rosacea Seborrheic Dermatitis, Intertrigo, Plantar Fasciitis, Endometriosis, Parabens Allergy Manifestated By Itchy And Rash Looks Like A Sunburn, Inflamed, Certain Uva And Uvb Blockers Allergy Manifestated By Hives, Itchy Hot Red, Sunburn Artificial Sweeteners Allerfy Manifestated By Migraine Reaction, Headache, Cigarettes Allergy Manifestated By Asthma Trigger, Cats Allergy Stuffy Nose And Sneezing And Asthma Trigger, Dust Allergy Manifestated By Stuffy Nose And Sneezing And Asthma Trigger, Pollen Allergy Manifestated By Stuffy Nose And Sneezing And Asthma Trigger, Mold Allergy Manifestated By Stuffy Nose And Sneezing And Asthma Trigger, Some Cleaning Chemicals Like Bleach Manifestated By Stuffy Nose And Sneezing And Asthma Trigger, No tobacco use, vitamin B1 deficiency, vitamin D3 deficiency, Pain, Irritable bowel syndrome, Acid Reflux, Asthma flares, Dopamine deficiency, Yeast rash underneath tummy, Polycystic ovary syndrome, Eczema, Attention-Deficit/Hyperactivity Disorder, Depression, Insomnia, Anxiety, High blood pressure, Allergies. Concomitant medications included thiamine hydrochloride (VITAMIN B1) taken for Supplement for vitamin B1 deficiency; vitamin d3 Supplement for vitamin D3 deficiency; meloxicam (MOBIC) taken for pain; bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTICS) taken for irritable bowel syndrome and for gut; methylpropylpropanediol dinitrate taken for Absorption Of Folic Acid; ascorbic acid taken for Acid Supplement To Help Absorb Iron; omeprazole taken for Acid Reflux; levosalbutamol hydrochloride (XOPENEX) taken for Asthma flares; bupropion hydrochloride (WELLBUTRIN) taken for Dopamine deficiency; econazole taken for Yeast rash underneath tummy; metformin taken for Polycystic ovary syndrome; pimecrolimus (ELIDEL) taken for eczema; methylphenidate hydrochloride (CONCERTA) taken for Attention-Deficit/Hyperactivity Disorder; lurasidone hydrochloride (LATUDA) taken for depression; methylcellulose taken for Fiber; melatonin taken for insomnia; clonazepam taken for anxiety; acetaminophen taken for pain; macrogol 3350 (MIRALAX) taken for Gut health regularity; duloxetine hydrochloride (CYMBALTA) taken for depression, pain; amlodipine taken for High blood pressure; magnesium oxide taken for Supplement; cetirizine hydrochloride (ZYRTEC) taken for Allergies; tacrolimus monohydrate (PROTOPIC) taken for eczema. On unknown dates, the patient experienced worsened anemia and abnormal lab values. In 2021, the patient experienced injection site itchiness, injection site raised or inflamed bump which looked liked a bad bug, injection site bruising, injection site bruising, itching, redness after receiving covid vaccine, injection site with a size of thumb and worsened menstrual symptoms. On 25Oct 2021, the patient experienced injection site blood and waited for 10 seconds before lifting pen/lifted the pen up medication/solution on top of skin/received partial injection/needle from pen looked a little bit crooked. The patient underwent lab tests and procedures which included Unspecified Blood Tests: unknown results, Lab test: unknown results, laboratory test: abnormal lab values, all on unknown date, Iron saturation: 8 % on 06Aug2020. On 25Oct2021, the waited for 10 seconds before lifting pen/lifted the pen up medication/solution on top of skin received partial injection/needle from pen looked a little bit crooked. Resolved. In Oct2021, the injection site blood resolved. In 2021, the injection site itchiness, injection site raised or inflamed bump which looked liked a bad bug, injection site bruising, injection site bruising, itching, redness after receiving covid vaccine and injection site with a size of thumb resolved. On an unknown date, abnormal lab values resolved. Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. Patient had injection site reactions after receiving covid vaccine bruising, itching, redness, bleeding and bruising. Patient had anemia after receiving covid vaccine. Patient stated that her anemia started to worsened after she began Humira therapy. Patient could not recall the date. In 2021, patient took iron direct intravenous transfusion six days a week over the summer when anemia worsened. Patient was not able to provide the specific dates of the iron transfusion. On mar2021 patient also stated that when she received Pfizer covid 19 vaccine she experienced injection site reactions whenever she injects Humira which includes the following: small injection site reaction, itching like crazy, raised or inflamed bump which looked like a bad bug bite, bruising, and with a size of thumb. Patient took anti-histamine for it but it did not help. These events would last for a week. On 25Oct2021, patient stated that on her previous injection, there was also an injection site blood. Patient stated that she bruise easily which might due to her anemia. Patient also mentioned worsening of her menstrual symptoms after receiving the Pfizer covid 19 vaccine. Patient underwent several unspecified blood tests but results of these were not provided. Patient received three doses of covid 19 vaccine. It was unknown if patient was enrolled in a covid-19 vaccine trial. On 10Mar2021, patient received 1st dose covid-19 vaccine manufactured by Pfizer/biontech, lot number en6207, expiration date not available. On 31Mar2021, patient received 2nd dose covid-19 vaccine manufactured by Pfizer/biontech, lot number er8732 expiration date not available. On 28Aug2021, patient received booster covid-19 vaccine manufactured by pfizer/biontech, lot number fc3183, expiration date not available. The patient was treated with pramoxine. The outcome of events anemia aggravated, menstrual disorder was not recovered, the outcome of rest events was recovered in 2021. Causality for Humira 40mg/0.4ml (adalimumab) the reporter's causality for the event (s) of worsened anemia, abnormal lab values, worsened menstrual symptoms, waited for 10 seconds before lifting pen/lifted the pen up medication/solution on top of skin/received partial injection/needle from pen looked a little bit crooked. Onset 25Oct2021 and waited for 10 seconds before lifting pen/lifted the pen up medication/solution on top of skin/received partial injection/needle from pen looked a little bit crooked. Onset 25Oct2021 was not provided. The reporter's causality for the event (s) of injection site blood, injection site itchiness, injection site raised or inflamed bump which looked liked a bad bug, injection site bruising, injection site bruising, itching, redness after receiving covid vaccine onset in 2021, injection site with a size of thumb, injection site bruising, itching, redness after receiving covid vaccine onset in 2021 and injection site bruising, itching, redness after receiving covid vaccine onset in 2021 with Humira 40mg/0.4 ml (adalimumab) was a reasonable possibility. Reporting Company's opinion is that there is no reasonable possibility that the events of worsened anemia, injection site bruising, itching, redness after receiving covid vaccine onset in 2021, worsened menstrual symptoms, waited for 10 seconds before lifting pen/lifted the pen up medication/solution on top of skin/received partial injection/needle from pen looked a little bit crooked. Onset 25Oct2021, waited for 10 seconds before lifting pen/lifted the pen up medication/solution on topof skin/received partial injection/needle from pen looked a little bit crooked. Onset 25Oct2021, injection site bruising, itching, redness after receiving covid vaccine onset in 2021 and injection site bruising, itching, redness after receiving covid vaccine onset in 2021 are related to Humira 4 omg/0.4ml (adalimumab). Reporting Company's opinion is that the event of abnormal lab values is not assessable. Reporting Company's opinion is that there is a reasonable possibility that the events of injection site blood, injection site itchiness, injection site raised or inflamed bump which looked liked a bad bug, injection site bruising and injection site with a size of thumb are related to Humira 40mg/0.4ml (adalimumab). The reporter's assessment of the causal relationship of the events with the suspect product 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 needed. No further information is expected.; Sender's Comments: As per available information in the case provided, the causal association between the events Anaemia, Laboratory test abnormal, Vaccination site pruritus, Vaccination site mass, Vaccination site bruising , Menstrual disorder, Vaccination site erythema , Vaccination site inflammation  and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.