Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Overdose, Product preparation error, Pyrexia
Clinical narrative: yellow caps was administered undiluted to a 6 months old pediatric patient; yellow caps was administered undiluted to a 6 months old pediatric patient; Patient had a 103 or 102 fever/spiked the fever; This is a spontaneous report received from an Other HCP from medical information team and a sales representative, Program ID.  A 6-month-old male patient received BNT162b2 omicron (kp.2) (PFIZER-BIONTECH COVID-19 VACCINE (2024-2025 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 01Oct2024, outcome "unknown", described as "Patient had a 103 or 102 fever/spiked the fever"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "yellow caps was administered undiluted to a 6 months old pediatric patient". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated that the inadvertent administration of a higher dose of the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 4 years of age with yellow caps, PC for the vaccine not including the diluent for its preparation. A Nurse calls for information about how to proceed after the Pfizer-BioNTech COVID-19 Vaccine (2024-2025 Formula) for individuals 6 months through 4 years of age with yellow caps was administered undiluted to a 6 months old pediatric patient, giving him a higher dose than recommended. The Nurse reports that Pfizer should include the diluent with the vaccine for an appropriate dilution of the product. Reporter called for information for safety and follow up actions for a patient who received a higher dose than recommended of the Pfizer COVID-19 vaccine 6 months through 4 years, but was administered undiluted, leading to a higher dose than the recommended administration. Reporter wants to file a product complaint because the vaccine does not come with the diluent. Caller reported maybe this is the root cause for the inappropriate dilution before administration of the vaccine. Reporter doesn't have any vaccines in the office that have to be diluted that does not come with diluent. Reporter just wanted to know what is going to happen to the child, the patient, that was just given the wrong vaccine. Reporter stated the patient was a doctor son, so patient father is going to be wanting the information. The reporter stated that, a customer (patient) who was using the Comirnaty Covid-19 vaccine (Clarified as Comirnaty). So, the customer gave a 6-month-old vaccine but did not dilute it and the patient had a 103 or 102 fever. Reporter stated, the patient was a 6-month-old male and a physician son. Reporter stated, the patient received had adverse event (fever) yesterday, so it was 10/1 (Clarified as 01Oct2024). When probed to clarify the start date of fever as 1st Oct2024, Reporter stated, Yes. The reporter was not sure still experiencing the adverse event, not sure treatment of adverse event, not sure on other medical conditions and other medications, not sure on lab tests. Details. Route: Pfizer sales representative stated, "It was injected, intramuscular injection. That is what the instruction says so yes, it will have to be that. The reporter not sure on anatomical site. The reporter not sure on any 4 weeks prior vaccination. Causality: Pfizer sales representative stated, correct, the baby spiked the fever after that it was given incorrectly without the diluent. Pfizer sales representative stated, "Can I also point out in the event, that when they ordered the vaccine, it did not alert them to include the diluent which is why she said that it was given without it. That might be important Pfizer sales representative was informed that everything will be mentioned in the report.   The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.