Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: This is a spontaneous report received from contactable reporters (Nurses) from medical information team. An 11-year-old male patient received BNT162b2 (BNT162B2), on 26May2022 as dose 2 (orange cap), 0.2 ml single (Lot number: FL8095) intramuscular, in left deltoid for COVID-19 immunisation. The patient's relevant medical history included: "Seasonal allergic rhinitis", start date: 12May2014 (ongoing); "Parental concern with child(s) weight", start date: 19Feb2021 (ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 26May2022, outcome "unknown" and all described as "0.2mL undiluted pediatric dose"; PYREXIA (non-serious) with onset 27May2022, outcome "recovered" (28May2022), described as "fever"; HEADACHE (non-serious) with onset 27May2022, outcome "recovered" (28May2022); NAUSEA (non-serious) with onset 27May2022, outcome "recovered" (28May2022); VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 27May2022, outcome "recovered" (28May2022) and all described as "pain and swelling at injection site". The events "0.2ml undiluted pediatric dose", "nausea", "pain and swelling at injection site", "headache" and "fever" required emergency room visit. Therapeutic measures were taken as a result of overdose, product preparation error, nausea, vaccination site pain, vaccination site swelling, headache, pyrexia. The reporter considered "0.2ml undiluted pediatric dose", "nausea", "pain and swelling at injection site", "headache" and "fever" not related to BNT162b2. Additional information: On 08Aug2022, a reporter elaborated that the medication error occurred during preparation/administration. It involved diluent not being added to vaccination due to human error. The patient had increased side effects including nausea, pain and swelling at insertion site, headache, and fever. The patient was seen in the emergency room on 27May2022 and was administered Zofran and ibuprofen. No additional follow-up nor relevant test was conducted and the patient was discharged on the same day (27May2022). The patient fully recovered on 28May2022. The patient had no prior vaccinations within 4 weeks. No follow up attempts are needed. No further information is expected. Follow-up (08Jul2022): Follow-up attempts are completed. No further information is expected. Follow-up (08Aug2022): This is a spontaneous follow-up report from a contactable Nurse. Updated information included: new reporter, patient information, relevant medical history, suspect product details (dosing regimen, vaccination facility), reaction data (event onset date, causality assessment, emergency room visit, treatment received), new events (nausea, vaccination site pain, vaccination site swelling, headache, pyrexia), clinical course details.; Sender's Comments: Reported events are probably associated to the overdose use of the suspect drug BNT162b2 and are therefore not related. Case to be re-assessed upon receipt of new information.