Age: 5.0
Sex: F
Vaccine: COVID19-2, COVID19, FLUC4
Symptoms: Product use issue, Retching, Somnolence, Vaccination site pain
Clinical narrative: have no smell or taste; body aches in legs and arms/sore in the left arm; sharp pain in side; barely raise their arms; sore at the injection site; girls have no smell; words were slurred and went away; BNT162B2 3rd dose and Flucelvax Quad on 20Oct2022; not diluted with sodium chloride and essentially received an adult dosage of covid vaccine; not diluted with sodium chloride and essentially received an adult dosage of covid vaccine; couldn't stand up; delusional; words were slurred; shortness of breath/ sitting on their chest and didn't feel like they could breath; kept gagging like she was choking, like something was blocking her throat; lethargic; nausea; very groggy; disoriented; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 3 (orange cap; booster), 28 ug single (Lot number: GK1657) at the age of 5 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 20Oct2022 as dose number unknown, 0.5ml single (Lot number: AS1596C, Expiration Date: 30Jun2023) intramuscular for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Lot number: FL8094, Dose 1), administration date: 24May2022, when the patient was 5-year-old, for COVID-19 immunization; BNT162b2 (Lot number: FL or FC8094, Dose 2), administration date: 14Jun2022, when the patient was 5-year-old, for COVID-19 immunization. The following information was reported: DISORIENTATION (non-serious) with onset Oct2022, outcome "unknown", described as "disoriented"; SOMNOLENCE (non-serious) with onset Oct2022, outcome "unknown", described as "very groggy"; PRODUCT USE ISSUE (non-serious) with onset 20Oct2022, outcome "unknown", described as "BNT162B2 3rd dose and Flucelvax Quad on 20Oct2022"; DYSSTASIA (non-serious) with onset 20Oct2022, outcome "unknown", described as "couldn't stand up"; DELUSIONAL DISORDER, UNSPECIFIED TYPE (non-serious) with onset 20Oct2022, outcome "unknown", described as "delusional"; RETCHING (non-serious) with onset 20Oct2022, outcome "unknown", described as "kept gagging like she was choking, like something was blocking her throat"; LETHARGY (non-serious) with onset 20Oct2022, outcome "unknown", described as "lethargic"; NAUSEA (non-serious) with onset 20Oct2022, outcome "unknown"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 20Oct2022, outcome "unknown" and all described as "not diluted with sodium chloride and essentially received an adult dosage of covid vaccine"; DYSPNOEA (non-serious) with onset 20Oct2022, outcome "unknown", described as "shortness of breath/ sitting on their chest and didn't feel like they could breath"; DYSARTHRIA (non-serious) with onset 20Oct2022, outcome "unknown", described as "words were slurred"; APHASIA (non-serious) with onset 20Oct2022, outcome "unknown", described as "words were slurred and went away"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 21Oct2022, outcome "not recovered", described as "barely raise their arms"; PAIN IN EXTREMITY (non-serious) with onset 21Oct2022, outcome "not recovered", described as "body aches in legs and arms/sore in the left arm"; ANOSMIA (non-serious) with onset 21Oct2022, outcome "not recovered", described as "girls have no smell"; AGEUSIA (non-serious) with onset 21Oct2022, outcome "not recovered", described as "have no smell or taste"; PAIN (non-serious) with onset 21Oct2022, outcome "not recovered", described as "sharp pain in side"; VACCINATION SITE PAIN (non-serious) with onset 21Oct2022, outcome "not recovered", described as "sore at the injection site". The events "very groggy", "lethargic", "disoriented", "couldn't stand up", "delusional", "words were slurred", "shortness of breath/ sitting on their chest and didn't feel like they could breath" and "words were slurred and went away" required emergency room visit. Additional information: Caller is the mother on behalf of her daughters who received wrong dosage of booster COVID vaccine. When attempting to clarify product and presentations caller is unsure and states she never saw the vial. Caller states she was told the vial was not diluted with sodium chloride and essentially received an adult dosage of COVID vaccine. Product was administered by an intern at the pharmacy. Caller asked are her children going to live as they are already having symptoms. Patients who were supposed to receive the bivalent booster orange cap Pfizer BioNtech COVID 19 vaccine for ages 5-11 years 0.2ml dose of 10 mcg mg. They were inadvertently given a dose undiluted, however requestor does not know exact dosage they were given and again states they were given a "full adult dosage". Caller clarifies her daughters received an adult dosage (28ug) instead of the child dosage. Her daughters are 5 and 7 years old. She is calling to report and because incorrect dosage. Her daughters has no smell and taste, body aches, runny nose, and fatigue. 5-year-old patient 5 and was very groggy and disoriented and. Caller took her daughters to the emergency room and spent all night there. She asks are her children going to live and what is going to happen since her children are already having symptoms. Immediately after shot went lethargic, couldn't stand up and delusional and the Pharmacist didn't check on her before the caller left with her kids. Her daughter had first 2 doses and wasn't like that. Her daughter couldn't stand and said mom her legs. Her daughter's words were slurred and went away. 20-30 minutes later both of her children started complaining someone is sitting on their chest and didn't feel like they could breath. 2 hours later the Pharmacist called the caller and said the incorrect dosage was given to her daughters. The girls had shortness of breath/ sitting on their chest and didn't feel like they could breath. On 21Oct2022, the girls have no smell or taste, body aches in legs and arms, grogginess, and sharp pain in side. Both girls are very sore at the injection site and can barely raise their arms. Caller clarifies the girls are sore in the left arm. Last night, patient had nausea and kept gagging like she was choking, like something was blocking her throat. Caller took her girls to the Emergency Room last night but were not admitted. The girls were discharged with follow up to Pediatrician in 3 days. The pharmacist said the 5-year-old dosage is to be diluted with Sodium Chloride and was not diluted and sol the girls were given more vaccine then supposed to get. Caller asked if the girls got a dose that would be given to her and the pharmacist said yes the girls got the same amount that an adult would get. The girls have an appointment scheduled for Monday. The doctors has her in a holding so if develop a fever then needs to bring in immediately.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201249407 same reporter/drug/event, different patient;