Age: 5.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Arthralgia, Overdose, Product preparation error, Product use issue, Pyrexia
Clinical narrative: low grade fever; soreness; received the entire undiluted vial of the pediatric formulation orange cap; received the entire undiluted vial of the pediatric formulation orange cap; the patient also got a flu vaccination today; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. A 5-year-old female patient received bnt162b2 (BNT162B2), administration date 20Jan2022 (Lot number: FK5618, Expiration Date: 28Mar2022) at the age of 5 years as dose 1 (tris), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 20Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious) with onset 20Jan2022 08:30, outcome "unknown", PRODUCT PREPARATION ERROR (non-serious) with onset 20Jan2022, outcome "unknown" and all described as "received the entire undiluted vial of the pediatric formulation orange cap"; PRODUCT USE ISSUE (non-serious) with onset 20Jan2022, outcome "unknown", described as "the patient also got a flu vaccination today"; PYREXIA (non-serious) with onset 21Jan2022, outcome "recovered" (22Jan2022), described as "low grade fever"; ARTHRALGIA (non-serious) with onset 21Jan2022, outcome "recovered" (22Jan2022), described as "soreness".  Additional information: A 5-years-old patient that received the entire undiluted vial of the paediatric formulation orange cap PFIZER BIONTECH COVID-19 vaccine. Caller mentioned that the patient seems to be okay and did not have a reaction. Caller states she knows no studies have been done, but she is the Performance Improvement Co-ordinator, and she was asked to call to see if there is any information available about this incident. Caller states thankfully the child is doing fine. Caller states she has completed a VAERS report. Caller states the patient also got a flu vaccination today as well. The overdose incident happened on Thursday, 20Jan2022 at 8:30am. On Friday, 21Jan2022, the patient had low grade fever and soreness. By Saturday when they checked on her, she was fine. No adverse events were reported on Sunday or Monday. Follow-up receieved on 07Feb2022: Phone out 3:26 pm. Phone answered by reporter who provided an update. The patient is doing fine and no adverse event issues. The parents cancelled the second dose which was supposed to happen on 10Feb2022. The parents indicated to the nurse that they do not want to provide weekly updates since their daughter is doing fine. Therefore, the nurse will not be able to monitor the patient moving forward. She will call if the patient comes in for any reason to report an adverse event.  Follow up (24Jan2022): This is a spontaneous follow-up report from a contactable other-HCP. This other-HCP reported in response to HCP letter sent via telephonic follow-up activity that included: Updated Information: Vaccine facility address updated. Start date for "Overdose" event was captured. New adverse events "low grade fever" and "soreness" were added.  Follow up (31Jan2022): This is a spontaneous follow-up report from a contactable other-HCP. This other-HCP reported in response to HCP letter sent via telephonic follow-up activity that included: Updated Information: Patient name was captured.  Follow up (07Feb2022, 08Feb2022): This is a spontaneous follow-up report from a contactable other-HCP. This other-HCP reported in response to HCP letter sent via telephonic follow-up activity that included: Updated Information: Clinical Information.  Follow-up attempts completed. No further information expected.