Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Hypersensitivity, Inappropriate schedule of product administration, Insomnia
Clinical narrative: Pfizer Covid Vaccine around the middle of Sep2021/second Pfizer Covid Vaccine around the end of Sep2021; nocturnal severe itching of palms, hands, and soles of the feet; elbow and joint pain; severe burning and itching at the palms of her hand, soles of her feet that lasted for months; have affected her activities of daily living; allergic reaction; especially in her elbows keep her from sleeping; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: Jan2021 (unspecified if ongoing), notes: her joints were so sore, especially her elbows. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, around middle of Sep2021, Route, Anatomical Location: arm), administration date: Sep2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (medically significant) with onset Sep2021, outcome "unknown", described as "Pfizer Covid Vaccine around the middle of Sep2021/second Pfizer Covid Vaccine around the end of Sep2021"; PRURITUS (medically significant) with onset 2021, outcome "recovering", described as "nocturnal severe itching of palms, hands, and soles of the feet"; ARTHRALGIA (medically significant) with onset 2021, outcome "recovering", described as "elbow and joint pain"; BURNING SENSATION (medically significant) with onset 2021, outcome "recovering", described as "severe burning and itching at the palms of her hand, soles of her feet that lasted for months"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (medically significant) with onset 2021, outcome "recovering", described as "have affected her activities of daily living"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "unknown", described as "allergic reaction"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "especially in her elbows keep her from sleeping". Therapeutic measures were taken as a result of pruritus, arthralgia, burning sensation, loss of personal independence in daily activities, hypersensitivity, insomnia.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported events due to temporal relationship. 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