Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Overdose, Product preparation error, Vaccination site discomfort
Clinical narrative: injection site discomfort for 3-4 days / arm discomfort at site injection; patient received the entire undiluted viral of bivalent COVID-19 orange cap vaccine; patient received the entire undiluted viral of bivalent COVID-19 orange cap vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team and a sales representative.  A 9-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Feb2023 at 12:45 as dose 3 (orange cap; booster), single (Lot number: GK1657, Expiration Date: 31Jan2024) at the age of 9 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Otitis Media", start date: 28Dec2022, stop date: 08Jan2023; "Covid-19", start date: 02Dec2021, stop date: 12Dec2021. There was no concomitant medications. Past drug history included: Amoxicillin, start date: 28Dec2022, stop date: 03Jan2023, for Otitis media, notes: Route: PO. Vaccination history included: BNT162b2 (Dose 1, Time (24hr): 10:15, Anatomical site of Injection: RA (Deltoid), Route of Administration: Intramuscular, Batch/Lot number: FL0007), administration date: 18Mar2022, when the patient was 8-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Time (24hr): 16:00, Anatomical site of Injection: LA (Deltoid), Batch/Lot number: FL0007), administration date: 11Apr2022, when the patient was 8-year-old, for COVID-19 immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 01Feb2023 at 12:45, outcome "unknown" and all described as "patient received the entire undiluted viral of bivalent COVID-19 orange cap vaccine"; VACCINATION SITE DISCOMFORT (non-serious), outcome "recovered", described as "injection site discomfort for 3-4 days / arm discomfort at site injection". The patient underwent the following laboratory tests and procedures: physical exams: (03Feb2023) Normal; (06Feb2023) Normal; (13Feb2023) Normal; (20Feb2023) Normal. Therapeutic measures were not taken as a result of product preparation error, overdose. Additional information. A 9 year old male patient received the entire undiluted viral of bivalent COVID-19 orange cap vaccine. [Name withheld], vaccine nurse was asking for any recommendations surrounding this administration error. I reviewed it on this topic with her. She was requesting a copy via email. AE - E-transfer to the agency; no additional information for non-phone cases. Facility type vaccine was Doctor's office/urgent care. If other vaccine in four weeks was unknown. A 9 year old male received the entire vial of undiluted bivalent orange cap vaccine. Patient had not received treatment for ae. Patient had not covid tested post vaccination. Other medical history was healthy. On 29Mar2023, it was reported that medication error was described as: patient was given 1.3 ml not diluted instead of 0.2 ml of Pfizer Bivalent. The medication error occurred when the product was prepared. Misunderstanding of instruction by the individual administering the medication: Checked. Followed up in clinic 03Feb2023, 06Feb2023, 13Feb2023 and 20Feb2023 to reassess for any reactions / side effects from overdose. Reported arm discomfort at site injection x 3 days but otherwise he was doing well. Normal physical exams (on 03Feb2023, 06Feb2023, 13Feb2023 and 20Feb2023). Patient lives with his father, girlfriend and neither expressed any concern about behavior, appetite activity level stating other than injection site discomfort for 3-4 days. Patient had no complains. The patient did not provide information to the nurse regarding the reported adverse event(s) with the use of the product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.  Follow-up (29Mar2023): Follow-up attempts are completed. No further information is expected.  Follow-up (29Mar2023): This is a spontaneous follow-up report from a contactable Nurse and Other HCP. Both Nurse and Other HCP reported in response to HCP letter sent which included that:  Updated Information included: New reporter (other HCP). Lab data, added past drug history, medical history and historical vaccine (dose 1, 2 and 3). Patient details (Height, Weight) updated. Product Details (Time of vaccination, Lot, Expiration Date, Anatomical Location,) updated. New Event of injection site discomfort for 3-4 days / arm discomfort at site injection added.