Age: 7.0
Sex: F
Vaccine: COVID19-2, COVID19, FLUC4
Symptoms: Off label use, Overdose, Pain, Pain in extremity, Product preparation error
Clinical narrative: If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: Vaccine Name: Inactivated Influenza Flucelvax Quad; If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: Vaccine Name: Inactivated Influenza Flucelvax Quad; the children were given because it was not diluted; the children were given because it was not diluted; body aches; runny nose; fatigue/Tiredness; complaining someone is sitting on their chest and didn't feel like they could breath/shortness of breath; legs are uncomfortable; have no smell or taste; have no smell or taste; body aches in legs and arms; body aches in legs and arms; grogginess; very sore at the injection site and can barely raise their arms; sharp pain in side; This is a spontaneous report received from contactable reporter(s) (Physician and Consumer or other non HCP) from medical information team.  A 7-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 4 (orange cap; booster), 28 ug single (Lot number: GK1657, Expiration Date: 31Jul2023) at the age of 7 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), as 0.5 ml seqirus (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 (1st dose Pfizer COVID-19 Vaccine:, Date Received: 09Nov2021, Lot number: FK5127, administration date: 09Nov2021, when the patient was 7-year-old, for COVID-19 Immunization; BNT162b2 (2nd dose Pfizer COVID-19 Vaccine:, Date Received: 30Nov2021, Lot number: FK5618, Same location as first dose), administration date: 30Nov2021, when the patient was 7-year-old, for COVID-19 Immunization; BNT162b2 (3rd dose Pfizer COVID-19 Vaccine: , Date Received: 14Jun2022, Lot Number: FL or FC 8094), administration date: 14Jun2022, when the patient was 7-year-old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 21Oct2022, outcome "unknown" and all described as "body aches in legs and arms"; SOMNOLENCE (non-serious) with onset 21Oct2022, outcome "unknown", described as "grogginess"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 21Oct2022, outcome "unknown" and all described as "have no smell or taste"; PAIN (non-serious) with onset 21Oct2022, outcome "unknown", described as "sharp pain in side"; VACCINATION SITE PAIN (non-serious) with onset 21Oct2022, outcome "unknown", described as "very sore at the injection site and can barely raise their arms"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: Vaccine Name: Inactivated Influenza Flucelvax Quad"; PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious), outcome "unknown" and all described as "the children were given because it was not diluted"; PAIN (non-serious), outcome "unknown", described as "body aches"; RHINORRHOEA (non-serious), outcome "unknown", described as "runny nose"; FATIGUE (non-serious), outcome "unknown", described as "fatigue/Tiredness "; DYSPNOEA (non-serious), outcome "unknown", described as "complaining someone is sitting on their chest and didn't feel like they could breath/shortness of breath"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "legs are uncomfortable". The events "have no smell or taste", "body aches", "runny nose", "fatigue/tiredness " and "legs are uncomfortable" required emergency room visit.  Clinical course: Caller was calling about the Pfizer Booster for 5 year old and 5 -11 year old. She took her daughters to get the booster and her daughters received the wrong dosage. Caller clarifies her daughters received an adult dosage instead of the child dosage. Her daughters are 5 and 7 years old. She was calling to report and because incorrect dosage. Her daughters has no smell and taste, body aches, runny nose, and fatigue. One child was 5 and was very groggy and disoriented and another was tired and legs are uncomfortable. Caller took her daughters to the emergency room and spent all night there. She asks are her children going to live and what was going to happen since her children are already having symptoms. 20-30 minutes later both of her children started complaining someone was 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. Today, 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. 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 was 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. Patient was in school and caller believes in keeping her safe. Caller had gotten the COVID shot and boosters and nothing has gone wrong. Vaccination Facility Type was Pharmacy. Patient had not Vaccine Administered at Military Facility. The pharmacy had an Intern to administer the vaccinations to her children. The Pharmacist stated neither pharmacist on duty went behind intern to verify vaccine or dosage. Patient had visit to Emergency Room. Patient had not visit to Physician Office. 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. Patient had not administration other vaccine Prior Vaccinations (within 4 weeks).  Follow-up (21Oct2022): This is a spontaneous follow-up report from a contactable consumer. This consumer reported for a patient that:   Updated information included: New primary reporter (address), Patient details, Historical vaccine, relevant medical history, dosage details, co-suspect and events.  Follow-up (26Oct2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201249236 same reporter/drug/event, different patient;