Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error, Pyrexia, SARS-CoV-2 test, Streptococcus test, Vaccination site mass
Clinical narrative: Fever of 103 degree fahrenheit orally; new chest pain; A dose was administered to a patient 10x more than the appropriate/authorized dose./10 times the appropriate dose was administered to a child; A dose was administered to a patient 10x more than the appropriate/authorized dose./10 times the appropriate dose was administered to a child; A dose was administered to a patient 10x more than the appropriate/authorized dose./10 times the appropriate dose was administered to a child; Dose: 1st, Date/Time: 29Sep2022, Expiry Date: Oct-2021; Pain/general body aches that day; arm swelling; lump at the injection site; The patient also developed a headache; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  A 9-year-old female patient received BNT162b2 (BNT162B2), on 29Sep2022 as dose 1 (orange cap), 2 ml single (Lot number: FL2757, Expiration Date: Oct2021) at the age of 9 years for covid-19 immunisation. The patient's relevant medical history included: "Gastritis", start date: 29Sep2022 (unspecified if ongoing), notes: Gastritis was prior to receiving the vaccine. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 29Sep2022, outcome "unknown" and all described as "A dose was administered to a patient 10x more than the appropriate/authorized dose./10 times the appropriate dose was administered to a child"; EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 29Sep2022, outcome "unknown", described as "Dose: 1st, Date/Time: 29Sep2022, Expiry Date: Oct-2021"; PAIN (non-serious) with onset 29Sep2022, outcome "unknown", described as "Pain/general body aches that day"; HEADACHE (non-serious) with onset 29Sep2022, outcome "unknown", described as "The patient also developed a headache"; PERIPHERAL SWELLING (non-serious) with onset 29Sep2022, outcome "unknown", described as "arm swelling"; VACCINATION SITE MASS (non-serious) with onset 29Sep2022, outcome "unknown", described as "lump at the injection site"; PYREXIA (non-serious) with onset 30Sep2022, outcome "recovered" (2022), described as "Fever of 103 degree fahrenheit orally"; CHEST PAIN (non-serious) with onset 30Sep2022, outcome "recovering", described as "new chest pain". The events "pain/general body aches that day", "arm swelling", "lump at the injection site", "the patient also developed a headache", "fever of 103 degree fahrenheit orally" and "new chest pain" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, peripheral swelling, vaccination site mass, headache, pyrexia, chest pain.  Additional infromation: Dose/Dosage Form: Orange cap, Original (Monovalent), 5 to 11 years - 10 mcg/dose, Dilute before use. The reporter was calling from Doctor's office in regards to the Pfizer COVID-19 vaccine orange cap. A dose was administered to a patient 10x more than the appropriate/authorized dose. Nurse clarified that 2ml instead of 0.2 ml was given to the patient. The reporter wants to know wants to know the next steps to take and concerns that parents may need to look for. Upon Follow up the reporter called and said because they work in a pediatric office and vaccinations for the Pfizer BioNTech COVID vaccine for the age of 5-12 was administered and 10 times the appropriate dose was administered to a child. So, they are calling to find out for that child. Caller states she is calling about the Pfizer BioNTech ages 5-11 and she needs to complete a VEARS report. Attempted clarification and caller states there was an adverse event, patient was given the wrong dose and she needs to report this. Attempted clarification on dose patient was given and caller states she was given 10x the normal dose. Caller then confirms it was the Pfizer BioNTech ages 5-11, orange cap. Caller states she doesn't know why it has an expiration date of Oct2021. Attempted to clarify if it was the manufacture date, caller was not sure. On 04Oct2022, it was reported that the patient had gastritis the day she came in for the COVID 19 vaccine. Gastritis was prior to receiving the vaccine. It was also reported that there was error in preparation and administration with contributing factors of human error at the clinic. It was reported that the woman who administered it did not pay attention to the instructions for reconstituting and administered the whole vial with dilution. The event resulted to emergency room visit only and not admitted. It was reported that on the day of the overdose event, the patient had pain, arm swelling, and a lump at the injection site. The patient also developed a headache and general body aches that day the 29Sep2022. The next day on 30Sep2022 by the evening she had developed fever of 103-degree Fahrenheit orally, and continued headache and new chest pain. She went to the ER for monitoring and tests but did not need any treatment. The ER (Emergency Room) did a whole bio panel for strep, flu/COVID, chest x-ray, and full blood panel. She was given Tylenol and Advil. All lab tests and scans came back OK. She did not need to be admitted. The nurse talked to the mother of the patient earlier today, and she reported her daughters chest pain has abated, no more fever, and was feeling better. She said it was traumatic and upsetting for her daughter to go through that.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (30Sep2022): This is a spontaneous follow-up report received from a contactable Other HCP. This Other HCP reported for a 9-year-old female patient that: Updated information included: New Reporter information was captured in slider #02 and Reporter information was updated in slider#01, patient tab (date of birth, weight, height was captured), product tab (lot number and expire date).  Follow-up (04Oct2022): This is a spontaneous follow-up report from a contactable nurse. This nurse reported in response to HCP letter. Updated information included: suspect product details (administration date, dose number), patient details (relevant medical history, age at vaccination and laboratory data), concomitant medication information, event details (event onset dates for Overdose, and Product administration error, new events Product preparation error, Expired product administered, Pain, Headache, Peripheral swelling, Vaccination site mass, Pyrexia, and Chest pain) and clinical course.