Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Petechiae, Vaccination site swelling
Clinical narrative: It (Covid-19 vaccine) had an expiration date of 19Aug2021; Swelling of injection site; Petechiae; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Physician) from medical information team for a Pfizer sponsored program (005570). The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101843260 (Pfizer).  A 6 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Dec2021 (Lot number: 5K5127, Expiration Date: 19Aug2021) at the age of 6 years as dose 2 (tris), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing), notes: Diagnosed about a year ago; "GERD" (ongoing), notes: Diagnosed at birth; "Bernard-Soulier syndrome" (ongoing), notes: States this is the bleeding disorder, which is part of the 22q11.2, Diagnosed probably about 4 years ago when patient had major bleed; "Thrombocytopenia" (ongoing), notes: Part of 22q11.2 , Diagnosed at birth; "22q11.2" (ongoing), notes: DiGeorge Syndrome Velocardiofacial Syndrome, 22q11.2 deletion conception; "Heart issues" (unspecified if ongoing), notes: Caller can't remember what they are Part of 22q11.2; "Has only one kidney" (unspecified if ongoing), notes: Part of 22q11.2; "Immunocompromised" (unspecified if ongoing), notes: She notes that her daughter has a bleeding disorder and is immunocompromised.; "Chronic Epistaxis" (ongoing), notes: birth; "ADHD" (unspecified if ongoing). Concomitant medication(s) included: FLU taken for immunisation, start date: Nov2021, stop date: Nov2021; IVIGLOB-EX; GUANFACINE taken for attention deficit hyperactivity disorder (ongoing). Vaccination history included: Bnt162b2 (Dose 1, LOT: FK5618, Route: Right upper arm), administration date: 29Nov2021, when the patient was 6 years old, for Covid-19 Immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 21Dec2021, outcome "unknown", described as "It (Covid-19 vaccine) had an expiration date of 19Aug2021"; VACCINATION SITE SWELLING (non-serious) with onset 21Dec2021, outcome "not recovered", described as "Swelling of injection site"; PETECHIAE (non-serious) with onset Dec2021, outcome "unknown", described as "Petechiae". Therapeutic measures were not taken as a result of vaccination site swelling, petechiae.  Additional information: Caller asked the pharmacist to look at the dose and the amount the patient was being given. Caller wanted to see the bottle and saw the expiry on the bottle was 19Aug2021. Caller stated that was expired. Pharmacist clarified saying no, the expiry has been extended and he would not administer the patient a dose if that expiry extension was not approved. Caller states her 6 y/o daughter received her first pediatric Pfizer Covid vaccine dose on 29Nov2021 and second dose on 21Dec2021. Within 5 minutes her injection site became swollen and she know has petechiae in the area. She notes that her daughter has a bleeding disorder and is immunocompromised.   No follow-up attempts are possible. No further information is expected.