Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Pain in extremity, Swelling of eyelid
Clinical narrative: Post booster injection/ Dose 1= Dose 2= 19Aug2021; Post booster injection/ Dose 1= Dose 2= 19Aug2021; Post booster injection; both eyes got very itchy. Left eye was more itchy; Eyelid began to swell slightly; arm pain; headache; fatigue; brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 38-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Aug2021 15:15 (Lot number: EW0198) at the age of 38 years as dose 3 (booster), single, administered in arm right, administration date 19Aug2021 (Lot number: ER8727) at the age of 38 years as dose 2 single and administered in arm right, administration date 19Aug2021 (Lot number: EN6204) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Ankylosing Spondylitis" (unspecified if ongoing); "Ceclor allergy" (unspecified if ongoing); "Allergy to Sulfa" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PREVACID; ADVIL [IBUPROFEN]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) all with onset 19Aug2021 19:15, outcome "not recovered" and all described as "Post booster injection/ Dose 1= Dose 2= 19Aug2021"; OFF LABEL USE (non-serious) with onset 19Aug2021 19:15, outcome "not recovered", described as "Post booster injection"; EYE PRURITUS (non-serious) with onset 19Aug2021 19:15, outcome "not recovered", described as "both eyes got very itchy. Left eye was more itchy"; SWELLING OF EYELID (non-serious) with onset 19Aug2021 19:15, outcome "not recovered", described as "Eyelid began to swell slightly"; PAIN IN EXTREMITY (non-serious) with onset 19Aug2021 19:15, outcome "not recovered", described as "arm pain"; HEADACHE (non-serious) with onset 19Aug2021 19:15, outcome "not recovered", described as "headache"; FATIGUE (non-serious) with onset 19Aug2021 19:15, outcome "not recovered", described as "fatigue"; FEELING ABNORMAL (non-serious) with onset 19Aug2021 19:15, outcome "not recovered", described as "brain fog". Therapeutic measures were not taken as a result of circumstance or information capable of leading to medication error, inappropriate schedule of product administration, off label use, eye pruritus, swelling of eyelid, pain in extremity, headache, fatigue, feeling abnormal. Additional information The patient did not have Covid prior to vaccination. The patient did not have Covid tested post vaccination. Patient had not received any other vaccine in four weeks, Adverse event: Post booster injection: Approx. 4 hours after injection, both eyes got very itchy. Left eye was more itchy. Eyelid began to swell slightly. No redness of eyes. Approx. 24 hours after injection left eyelid approx. 1/3 swollen shut, no pain, no redness of eyes, no vision impedance. Right eyelid slightly swollen but no vision impedance. General side effects including arm pain, headache, fatigue, brain fog, lasted approx. 30 hours. Follow-up attempts are completed. No further information is expected.