Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction, Overdose, Pain, Product preparation error, Pyrexia
Clinical narrative: 3 children were given booster doses of the orange cap that were not diluted; 3 children were given booster doses of the orange cap that were not diluted; fever; achiness; more robust immune response; This is a spontaneous report received from contactable reporter(s) (Nurse and Physician) from medical information team.  An 11-year-old male patient received BNT162b2 (BNT162B2), on 26Aug2022 at 15:03 as dose 3 (booster), 0.2 ml single (Lot number: FL8095, Expiration Date: 31Aug2022) at the age of 11 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: FK5127; Route of administration: Intramuscular; Anatomical location: Left arm; Administration time: 14:34), administration date: 04Nov2021, when the patient was 10-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: FK5127; Route of administration: Intramuscular; Anatomical location: Left arm; Administration time: 15:17), administration date: 03Dec2021, when the patient was 10-year-old, for COVID-19 Immunization; flu shot (Vaccine name: Flu shot; Manufacturer: Sanofi; Batch/Lot: 4T7325JA; Route: intramuscular; Anatomical site if injection: Left arm; No. of previous doses: Yearly), administration date: 16Oct2021, when the patient was 10-year-old, for Immunization. The following information was reported: IMMUNISATION REACTION (non-serious) with onset 2022, outcome "unknown", described as "more robust immune response"; PAIN (non-serious) with onset 26Aug2022, outcome "recovered" (2022), described as "achiness"; PYREXIA (non-serious) with onset 26Aug2022, outcome "recovered" (2022), described as "fever"; OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 26Aug2022 at 15:00, outcome "unknown" and all described as "3 children were given booster doses of the orange cap that were not diluted". Therapeutic measures were taken as a result of immunisation reaction, pyrexia, pain.  Additional Information: Reporter reported that, 3 children were given booster doses of the Pfizer Covid 19 vaccine orange cap that were not diluted. Reporter was asking for further guidance. Reporter asked when do local and systemic adverse event happen usually. Reporter asked if she had to report this to somewhere. NDC number of Pfizer Covid-19 Vaccine was reported as 59267-1055-04. This report was 3 of 3. She asked if they have seen this issue before, should they just watch them closely to make sure, what should she do then. There were no prior vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). There was no additional vaccine administered on same date. The patient provided information regarding the reporter adverse event (s) with the use of the product and was considered the Pfizer product had a causal effect to the adverse event. The patient's concomitant drugs were reported as none. Relevant tests and specific relevant test for thromboembolic events with thrombocytopenia were reported as none. The patient was treated at home with OTC product for the event robust immune response.  Follow-Up (06Sep2022): Follow-up attempts are completed. No further information is expected.  Follow-up (17Oct2022): This is a spontaneous follow-up report received from a contactable physician.  Updated information included: reporter information (updated secondary reporter to true reporter and reporter details added), patient details (added historical vaccine (flu shot vaccine) and added medical history of eczema), suspect drug (added vaccine administration time, route of administration, vaccine facility name and address line), reaction data (added new events of IMMUNE SYSTEM DISORDER, PAIN and PYREXIA) and narrative updated.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201099254 same drug/events, different patient.;