Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Overdose, Pain, Pain in extremity, Product administered to patient of inappropriate age
Clinical narrative: bruising; more achiness; Pain at injection (left arm); Stomach pain; Nauseous; Slight fever/more fever; Fatigue; arm soreness; Headache; they are 11 yeas old my kids, twins but they were given the adult doses; grabbed the wrong vial; they are 11 yeas old my kids, twins but they were given the adult doses; grabbed the wrong vial; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the parent.  An 11-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 as dose 4 (booster), 0.3 ug single (Lot number: GH9697, Expiration Date: 10Jan2023) at the age of 11 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 3, Lot: FL8095), administration date: 08Aug2022, when the patient was 10-year-old, for COVID-19 immunization; Bnt162b2 (Dose: 1, Lot: FK5618), administration date: Nov2021, when the patient was 10 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot: FK5127), administration date: Dec2021, when the patient was 10 years old, for COVID-19 immunization. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 04Nov2022, outcome "unknown", OVERDOSE (non-serious) with onset 04Nov2022, outcome "recovered" and all described as "they are 11 yeas old my kids, twins but they were given the adult doses; grabbed the wrong vial"; FATIGUE (non-serious) with onset 05Nov2022, outcome "recovered" (05Nov2022); HEADACHE (non-serious) with onset 05Nov2022, outcome "recovered" (06Nov2022); NAUSEA (non-serious) with onset 05Nov2022, outcome "recovered" (05Nov2022), described as "Nauseous"; VACCINATION SITE PAIN (non-serious) with onset 05Nov2022, outcome "recovering", described as "Pain at injection (left arm)"; PYREXIA (non-serious) with onset 05Nov2022, outcome "recovered" (06Nov2022), described as "Slight fever/more fever"; ABDOMINAL PAIN UPPER (non-serious) with onset 05Nov2022, outcome "recovered" (06Nov2022), described as "Stomach pain"; PAIN IN EXTREMITY (non-serious) with onset 05Nov2022, outcome "recovering", described as "arm soreness"; CONTUSION (non-serious), outcome "unknown", described as "bruising"; PAIN (non-serious), outcome "unknown", described as "more achiness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of overdose, fatigue, pain in extremity, abdominal pain upper, nausea, vaccination site pain. Therapeutic measures were taken as a result of pyrexia, headache.  Additional information: Reporter stated that reporter was trying to, and walking kids to the pediatrician. They went and got their Pfizer Omicron boosters (Clarified as Pfizer COVID-19 Vaccine) yesterday. The pharmacy they went to wrote one thing down on the vaccination card but than, they are 11 yeas old kids, twins but they were given the adult doses not the child dose and reporter concern was, reporter talked to the pediatrician they were just having some, and patient daughter had like a 99 degree fever and they had just fatigue and arm soreness and a headache so nothing, and reporter asked about know more reaction they had on the kids dose. Reporter stated, that the kids got the wrong dose they got the adult one. Right, because the dose was told 30 micrograms. Caller would like to know the risk regarding that Resolutions. Gathered caller's concern/inquiry-Gathered. Advise provider stated that it will not going to affect the kids in the long term, understand side effects and know it was not dangerous. Possibly more side effect issues. Patient shot site hurts still and notes bruising as well. Patient seems fine. The father states, from all the studies, no adverse long-term effects that anyone has seen. Patient date of birth was told three times so there was no issue with the children. Son told them he was eleven and they wrote on the card Pfizer pediatric booster 6K1657, however 2-3 minutes after the shot they were standing in the aisle 15 minutes after the pharmacy tech gave the shot. Mentioned that she went in quick when she went in and got the vaccine. They had more reaction than the one in Aug2022. Clarified that patient arm hurting was over. Had more symptoms and fatigue over the weekend than any dose previously had. Called because he was trying to make sure that his kids okay over the weekend. Was told that it was the wrong dose paperwork that they gave him which said the Pfizer updated booster 5-11 NDC 59267-0565-01. she had pain at the site and stomach pain. Watched patient diet but no medical treatment. Later clarified that they kept her at breads and stuff for a couple of hours and by the end of the day was fine. For headache and slight fever patient treated with children's Tylenol. Patient had the original dose and then the booster in Aug2022. Clarified that they had the Pfizer vaccine in Nov2021 with a lot of FK5618 and the second Pfizer vaccine in Dec2021 with a lot of FK5127. Clarified that on 08Aug2022 they had the Pfizer Booster with a lot number of FL8095. NDC provided above was crossed out and underneath it was NDC 59267-0304-01. Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent),grater than equal  12 years 15/15 mcg per dos. Question: Caller states that his 11 year old kids were given the incorrect dosage for the Pfizer COVID Vaccine. He followed up with his pediatrician and they are fine. He notes this was on Friday. He is now calling Pfizer to double check his information that he has sought out over the weekend through the internet, his peds office and the (pharmacy withheld).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201280900 same drug/AE, diferent patient;