Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Overdose, Product administered at inappropriate site, Product administered to patient of inappropriate age
Clinical narrative: child has been overdosed with the vaccine/got purple-cap vaccine dose/received adult dose of vaccine; child has been overdosed with the vaccine/got purple-cap vaccine dose/received adult dose of vaccine; Received vaccine in right leg; she was given the adult dose and she is a 57 pound child.; headaches; dizziness/dizzy; feels like she needs to throw up/Nauseous; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 9 year-old female patient received bnt162b2 (COMIRNATY), administered in leg right, administration date 14Nov2021 13:30 (Batch/Lot number: unknown) at the age of 9 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious), INCORRECT DOSE ADMINISTERED (non-serious) all with onset 14Nov2021 13:30, outcome "unknown" and all described as "child has been overdosed with the vaccine/got purple-cap vaccine dose/received adult dose of vaccine"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 14Nov2021 13:30, outcome "unknown", described as "Received vaccine in right leg"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 14Nov2021, outcome "recovered with sequelae", described as "she was given the adult dose and she is a 57 pound child."; HEADACHE (non-serious) with onset 14Nov2021, outcome "not recovered", described as "headaches"; DIZZINESS (non-serious) with onset 14Nov2021, outcome "unknown", described as "dizziness/dizzy"; NAUSEA (non-serious) with onset 14Nov2021, outcome "unknown", described as "feels like she needs to throw up/Nauseous". The events "child has been overdosed with the vaccine/got purple-cap vaccine dose/received adult dose of vaccine", "child has been overdosed with the vaccine/got purple-cap vaccine dose/received adult dose of vaccine", "received vaccine in right leg", "headaches", "dizziness/dizzy" and "feels like she needs to throw up/nauseous" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Additional information: The reporter wants to know what to do when a child has been overdosed with the vaccine? Got purple-cap vaccine dose, "syringes were already loaded". Patient is 9.5-year-old, 57 lbs., granddaughter of caller, received adult dose of vaccine 14Nov2021 at approx. 13:30. Experiencing headaches, dizziness, feels like she "needs to throw up". Received vaccine in "right leg". Had EKG 48 hours later as follow-up, per caller. In Response: Read from attached document Inadvertent Administration of Higher than the Recommended Dose (10 mcg) in 5 through 11 years of age (ORANGE CAP) (v2.0) under EUA Prescribing Information. Referred to HCP. Upon follow-up (17Nov2021): The nurse reported for a female patient that: The Reaction/event as reported by primary source: stated that she got the adult dose of Covid vaccine; Date of start of reaction/event: 14Nov2021; Date of end of reaction/event: 14Nov2021; Outcome of reaction/event at the time of last observation: Recovered/resolved with sequel. Reporter states her granddaughter has headaches, dizzy and feels like she needs to throw up. Stated that she got the vaccine in her right leg. Event details: Stated that she started having headaches within an hour of having the shot. Stated that she is still having headaches. Stated that the clinic knew that day but did not let them know until 4:00 the next day and it took another day to see her. Stated that she saw on the news that a couple of kids got the adult dose and ended up with cardiac issues. Stated that did an ESR and EKG. Stated that she asked if they could do those tests. Stated that when they got there that they only did the EKG. Stated that the paediatrician stated they did it because they were curious. Unable to clarify details. Upon follow-up (17Nov2021): The Nurse reported for a patient that: the patient's grandmother had a concern: Reporter stated, she took her granddaughter, sorry on Sunday to get a vaccine and she was given the adult dose and she is a 57-pound child. So, what should we do? We didn't find out till the day after and we talked to them and they got her send yesterday afternoon we are supposed to get some labs done and EKG and then we normally do the EKG they said they want to do the labs just because we were curious, we were curious and concerned she has been dizzy ever since she got in less than an hour when she got the shot and dizzy and she is been nauseous and she had a headache and we are concerned. She obviously shouldn't have received that dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.