Age: 8.0
Sex: M
Vaccine: COVID19-2, COVID19
Symptoms: Eye irritation, Incorrect dose administered, Loss of personal independence in daily activities, Oropharyngeal pain, Product preparation issue
Clinical narrative: sore throat; runny nose; Itchy eye; burning in one eye; Wrong vaccine administered; Undiluted dose of the vaccine; Undiluted dose of the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 8-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Jan2023 as dose 1 (orange cap), single (Lot number: GK1657) at the age of 8 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Allergic to amoxicillin, reaction(s): "Allergic to amoxicillin", notes: Allergic to amoxicillin, Caller states that her son was 2-3 years old when this allergy was discovered.  The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 30Jan2023, outcome "unknown" and all described as "Undiluted dose of the vaccine"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 30Jan2023, outcome "unknown", described as "Wrong vaccine administered"; EYE PRURITUS (non-serious) with onset 01Feb2023, outcome "recovered" (02Feb2023), described as "Itchy eye"; EYE IRRITATION (non-serious) with onset 01Feb2023, outcome "unknown", described as "burning in one eye"; RHINORRHOEA (non-serious) with onset 01Feb2023, outcome "recovered" (04Feb2023), described as "runny nose"; OROPHARYNGEAL PAIN (non-serious) with onset 01Feb2023, outcome "unknown", described as "sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rhinorrhoea, eye pruritus.  Additional information: The patient received the wrong dosage at the doctor's office. Dosage text: First dose, left shoulder, injection. Patient received a concentrated, undiluted dose, equal to probably 2 times the normal amount. The reporter wanted to know if there were any adverse reactions or any other things to look for. Or if there were any information from the trials related to anything long term. States that she was calling about her son. Her son received the wrong dosage at the doctor's office. The reporter states that she does not have a lot of information. They said her son received a concentrated, undiluted dose, equal to probably 2 times the normal amount. HCP information was unknown. The reporter stated that the office said they contacted Pfizer already, caller stated that they are not being very forthcoming with information to her, that was why she decided to call Pfizer herself. The reporter stated that she does not know the cap color of the vaccine. Mentioned again that the office was not being very forthcoming with information for her. Reporter stated that she does not trust the office's information. Reporter stated that she knew her son received the left shoulder, and it was an injection, stated it seemed like it was in the muscle, but she does not know. Caller denied any other medications for her son relevant to these events. Caller denied any labs, testing, or treatments for her son related to this event. Stated that she doesn't know if she should have any or not. Prior vaccinations (within 4 weeks) were reported as none. Inquiry is regarding her son receiving a double undiluted dose of the Pfizer COVID 19 vaccine bivalent orange cap for 5-11 years of age. As of 02May2023, it was reported that On Monday 30Jan2023 the Pfizer COVID-19 bivalent for 5-11 yrs was administered to patient without being diluted first. As a result he received a higher than recommended dose. Post administration he complained of burning in one eye and missed school due to sore throat on Wednesday 01Feb2023. Doctor was altered as soon as the error was discovered and parents were notified. Undiluted Pfizer COVID-19 bivalent for 5-11 yrs vaccine was administered to patient. Medication error occurred when the product was prepared. Error was not noticed and intercepted before the product was supplied to patient. Error was not noticed and intercepted before the product was supplied to patient. Factor considered to be responsible for the medication error: misunderstanding of instructions by the individual administering the medication. Is product still being taken: no. Vaccination Facility Type: Doctor's Office/Urgent Care. Concomitant medication, Medical history and Relevant tests: None.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (02Feb2023 and 06Feb2023): This is a spontaneous follow up report from a contactable consumer. This consumer reported for a patient that: Updated information included: reporter details (zip code) and additional information was updated.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (02May2023): This is a spontaneous follow-up report from a contactable consumer. This consumer reported for a patient in response to non-HCP letter sent via follow-up letter which included that: Reporter information, Patient details were updated, RMH, Suspect information (anatomical location, route and Vaccine facility details), New events updated (Itchy eyes, burning in one eye and Runny nose) and Additional information added.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.