Age: 60.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Dysgeusia, Injection site erythema, Injection site induration, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Her upper arm and deltoid started aching; she could not type or write and could not cook and was so painful/It is affecting her job and her ability to use her arm; muscle weakness; there could be swelling that is pushing it; when she woke up her shoulder hurt/felt the pain move forward toward her shoulder; pain at the injection site/The induration was very painful; red area that was 18mm by 14mm and was pretty big; the induration because it was very tender to touch; it hurts into her clavicle; weird taste in her mouth described as kind of metallic; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 26Oct2023 as dose 1, 0.3 ml single (Lot number: HG2282, Expiration Date: Nov2024) at the age of 60 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Anemia" (ongoing); "to keep her blood pressure low because she is anemic" (unspecified if ongoing). Concomitant medication(s) included: BYSTOLIC oral taken for hypertension (ongoing). The following information was reported: BONE PAIN (disability, medically significant) with onset 26Oct2023, outcome "recovered" (Oct2023), described as "it hurts into her clavicle"; DYSGEUSIA (non-serious) with onset 26Oct2023, outcome "recovered" (Oct2023), described as "weird taste in her mouth described as kind of metallic"; VACCINATION SITE PAIN (disability, medically significant) with onset 27Oct2023, outcome "recovered", described as "pain at the injection site/The induration was very painful"; VACCINATION SITE ERYTHEMA (disability, medically significant) with onset 27Oct2023, outcome "recovered" (Nov2023), described as "red area that was 18mm by 14mm and was pretty big"; VACCINATION SITE INDURATION (disability, medically significant) with onset 27Oct2023, outcome "recovered" (Nov2023), described as "the induration because it was very tender to touch"; ARTHRALGIA (disability, medically significant) with onset 03Nov2023, outcome "not recovered", described as "when she woke up her shoulder hurt/felt the pain move forward toward her shoulder"; JOINT SWELLING (disability, medically significant) with onset 09Nov2023, outcome "not recovered", described as "there could be swelling that is pushing it"; PAIN IN EXTREMITY (disability, medically significant), outcome "not recovered", described as "Her upper arm and deltoid started aching"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability, medically significant), outcome "not recovered", described as "she could not type or write and could not cook and was so painful/It is affecting her job and her ability to use her arm"; MUSCULAR WEAKNESS (disability, medically significant), outcome "unknown", described as "muscle weakness". Clinical course was reported as follows: Patient reported she had weird taste in her mouth like when take Bactrim, like a metal in your mouth. This occurred the night of the first day. It is a rare reaction, but does happen and lasted 3 days. It lasted from 26Oct2023 until like 29Oct2023 ot 30Oct2023. Localized reaction: Clarified that the next day she felt pain at the injection site. There was a red area that was 18mm by 14mm and was pretty big. The injection was given correctly. She measured the induration because it was very tender to touch, the area of induration started on the 27Oct2023 and measured 14mm by 12mm and she marked it with a sharpie. The induration was very painful. It resolved slowly over the course of 2 weeks. Stated that she treated the area with triamcinolone cream. She treated the area slowly at first because it was so painful to touch. As the area got smaller it got less tender. She used the cream appropriately. She had no fever and did not feel the need to take anything systemic. Stated that it was medically significant and disabling, she could not type or write and could not cook and was so painful, but was not disabling to the point to where she sought medical treatment. Her upper arm and deltoid, from the deltoid tuberosity on her arm to a whole part of her arm started aching within about a week after the injection. When she would turn over it would wake her up because it hurt. It was the whole deltoid and bicep area. This was while the induration was resolving. It is worse because it now is including muscle weakness. Stated that it hurts and had muscle weakness. It affected her job and her ability to use her arm. Generalized reaction: On 03Nov2023, clarified that morning of 04Nov2023, she noticed when she woke up her shoulder hurt. She started taking Ibuprofen 800mg. She also used Lidoderm patch 5% while sleeping 12 hours on and 12 hours off. She could not take 800mg ibuprofen because it bothers her stomach a lot, but she took it occasionally. On 09Nov2023, last Thursday, she moved a certain way and felt the pain move forward toward her shoulder. Her shoulder area did not look particularly swollen. She though there could be swelling that is pushing it. it was not getting worse but it was not noticeably worse, but is not any better.; Sender's Comments: Based on the information available, the causal relationship between the reported serious events and suspect drug BNT162B2 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