Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort, Oropharyngeal pain, Overdose, Product administered to patient of inappropriate age, Swelling
Clinical narrative: The ER note says she had some dental work done and then some neck swelling and a sore throat; The ER note says she had some dental work done and then some neck swelling and a sore throat; The ER note says she had some dental work done and then some neck swelling and a sore throat; COVID-19 vaccine gray cap that was administered to a 9-year-old patient instead of the orange cap/ a patient (female, 9 years of age) received the COVID-19 vaccine gray cap instead of the orange cap; COVID-19 vaccine gray cap that was administered to a 9-year-old patient instead of the orange cap/ a patient (female, 9 years of age) received the COVID-19 vaccine gray cap instead of the orange cap; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 9-year-old female patient received BNT162b2 (BNT162B2), on 09Nov2022 as dose 2, 0.3 ml single (Lot number: FP7140, Expiration Date: 22Dec2022) at the age of 9 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose:01, lot: FT1551, NDC: 59267105501, exp: 24Nov2022, Product: Pfizer orange cap 0.2mL in left deltoid, Route of Administration: intramuscular), administration date: 11Oct2022, when the patient was 9-year-old, for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) all with onset 09Nov2022, outcome "unknown" and all described as "COVID-19 vaccine gray cap that was administered to a 9-year-old patient instead of the orange cap/ a patient (female, 9 years of age) received the COVID-19 vaccine gray cap instead of the orange cap"; OROPHARYNGEAL PAIN (hospitalization), SWELLING (hospitalization), DENTAL DISCOMFORT (hospitalization) all with onset 01Dec2022, outcome "unknown" and all described as "The ER note says she had some dental work done and then some neck swelling and a sore throat". The events "the er note says she had some dental work done and then some neck swelling and a sore throat" required emergency room visit. Therapeutic measures were taken as a result of oropharyngeal pain, swelling.  Clinical course: It was reported that the patient was administered with COVID-19 vaccine gray cap to a 09-year-old patient instead of the orange cap. They wanted to get indications, and if they must re-administer the vaccine or not. Reported that patient waited for 15 minutes after a COVID vaccine, and no reactions were noted. She does see an ER visit on 01Dec2022. She doesn't know if it is related or not. The ER note says she had some dental work done and then some neck swelling and a sore throat. They admitted her to the hospital for further monitoring and IV antibiotics. The note is relating it to dental work the patient had done. Dates of hospitalization: Caller stated all she has is that patient just went in 01Dec2022, no discharge date listed.; Sender's Comments: Based on the available reported information, the causal association between the event Sore throat, Neck swelling , Dental discomfort  and the suspect drug BNT162B2 cannot be excluded The case will be reassessed once new information is available.  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 RAs, Ethics Committees, and Investigators, as appropriate.