Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 17:00 (Lot number: 30155BA) at the age of 26 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Hasimoto's hypothyroidism", start date: Aug2011 (ongoing), notes: N/A; "atopic dermatitis", start date: 29Sep1995 (ongoing), notes: autoimmune disease, Non fungal, non-bac dermatitis.; "herniated disc L5/S1 since 1 month" (unspecified if ongoing), notes: Verbatim: herniated disc L5/S1 since 1 month; "Allergies: Penicillin" (unspecified if ongoing); "Allergies: Dogs" (unspecified if ongoing); "Allergies: Mold" (unspecified if ongoing). Concomitant medication(s) included: DUPIXENT taken for dermatitis atopic, start date: Apr2021 (ongoing); SYNTHROID taken for hypothyroidism, start date: Aug2011 (ongoing); TIZANIDINE; MELOXICAM; VIT D taken for hypovitaminosis, start date: Nov2020 (ongoing). Past drug history included: Cephalosporins, reaction(s): "Known allergies: Cephalosporins". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3246, Location of injection: Arm Left, Vaccine Administration Time: 5:00 PM), administration date: 07Jan2021, when the patient was 25 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9262, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 25Jan2021, when the patient was 25 years old, for COVID-19 immunization, reaction(s): "previous dose administration date 25Jan2021;prev dose administration date: 07Jan2021". The following information was reported: PARAESTHESIA (medically significant) with onset 02Oct2021 04:45, outcome "recovered", described as "tingling about 24 hours after vaccination in inner ear, upper chest, neck, both arms"; BURNING SENSATION (medically significant) with onset 02Oct2021 04:45, outcome "recovered", described as "burning sensation"; VACCINATION SITE PAIN (medically significant) with onset 02Oct2021 04:45, outcome "recovered", described as "Injection site soreness". Therapeutic measures were not taken as a result of paraesthesia, burning sensation, vaccination site pain. Clinical course: The most recent COVID-19 vaccine was administered at the Hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant test: None. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Follow-up attempts are completed. No further information is expected. Sender's Comments: Based on the information provided in the narrative a possible contributory role of the suspect vaccine BNT162B2 to reported event of Vaccination site pain, paresthesia, and burning sensation 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.