Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Product preparation error, Vaccination site pain
Clinical narrative: She gave undiluted 0.2mL doses of the vials instead of diluting the formulation before administration.; She gave undiluted 0.2mL doses of the vials instead of diluting the formulation before administration.; Soreness at injection site; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 7-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 26Jan2022 15:10 (Lot number: FL0007, Expiration Date: 28Feb2022) at the age of 7 years as dose 1 (tris), 0.2 ml single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 26Jan2022 15:10, outcome "unknown" and all described as "She gave undiluted 0.2mL doses of the vials instead of diluting the formulation before administration."; VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "Soreness at injection site". Therapeutic measures were not taken as a result of overdose, product preparation error.  Additional information: The reporter stated that inquiry is regarding the Pfizer COVID 19 Vaccine orange cap vials. The reporter gave undiluted 0.2mL doses of the vials instead of diluting the formulation before administration. The reporter stated that it was given to a total of 4 patients, 2 boys and 2 girls, 7-10 years of age, 2 of them took it as their 1st shot, while the remaining 2 took them as their 2nd shot. The reporter already informed parents of the children regarding medication error, and of the risk of possible increased side effects. The reporter wanted more data on revaccination.  Reporter seriousness for gave undiluted dose of vials instead of diluted ones was medically significant. The number of COVID-19 vaccine pediatric is 59267-1055-4. The reporter said according to the research this was not serious, but as someone who made an error it was causing her a lot of angst and was very significant to her, it made her want to throw up because she made a mistake, which she had been doing this almost two years and had not made this mistake, though for the pediatrics it hasn't been that long. The patient provided information regarding the reported adverse events with the use of the product and the Pfizer product had a causal effect to the adverse events as no. No prior vaccinations within 4 weeks were reported. Relevant test for thromboembolic events with thrombocytopenia was none. It was reported that pre and administration error. The reporter stated that had been preparing Moderna, Pfizer grey cap (Tris) no need to dilute. Patient came early and nurse was asked to get pediatric vaccine ready. Nurse should not have ready. Patient mother reported that child was fine and absolutely no side effects other than soreness at injection site.  Follow-up (08Jan2022): New follow-up spontaneous report from a same contactable nurse in response to HCP letter sent via follow-up activity. Updated information included: Vaccination time, route of administration, event onset time, event added vaccination site pain, causality and updated additional information.  No follow-up attempts are possible. No further information is expected.