Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Overdose, Pain, Product preparation error, Pyrexia
Clinical narrative: pain at the injection site; body aches; runny nose; fever; they forgot to dilute it so she got a full dose of the vaccine undiluted; they forgot to dilute it so she got a full dose of the vaccine undiluted; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 8-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 as dose 4 (orange cap; booster), single (Batch/Lot number: unknown) at the age of 8 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, SINGLE, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 25Oct2022 at 17:00, outcome "unknown" and all described as "they forgot to dilute it so she got a full dose of the vaccine undiluted"; PAIN (non-serious) with onset 26Oct2022, outcome "not recovered", described as "body aches"; PYREXIA (non-serious) with onset 26Oct2022, outcome "not recovered", described as "fever"; VACCINATION SITE PAIN (non-serious) with onset 26Oct2022, outcome "not recovered", described as "pain at the injection site"; RHINORRHOEA (non-serious) with onset 26Oct2022, outcome "not recovered", described as "runny nose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, pain, rhinorrhoea, pyrexia.  Additional information: The caller stated his daughter recently got the Pfizer BioNTech Covid-19 Bivalent booster dose on Tuesday at (name withheld). He did not know the cap color but said she is 8 years old so assumes it is the pediatric orange cap. He got a call from the pharmacy saying they forgot to dilute it so she got a full dose of the vaccine undiluted. He took her at about 5:00 and they called him around 7:00 and the pharmacy had called poison control and poison control was not worried. He called the physician to see what would be ok for her comfort because her side effects were intense and he was wanting to see if Tylenol or ibuprofen was okay. The physician told him the dose she received was going to be ineffective. Now, the customer wanted to know what should happen next and does not want to make her go through that again. Calling on Tuesday took his 8 year old to get the Bivalent booster and they forgot to dilute it and got a full dose. They said something about waiting to redo it, but they that would probably have to. Other Products: No. Booster dose due to high risk or frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications): N/A. Booster dose due to a weakened immune system: if the reason is a weakened immune system, please select one of the conditions below: N/A. Current or recent cancer (including blood cancers such as Hodgkins disease, leukemias, and myelomas), Advanced or untreated HIV infection; Use of medications that suppress the immune system (e.g., high-dose corticosteroids, cyclosporine, methotrexate, azathioprine, and biologic therapies like rituximab and etanercept);No/non-functioning, spleen, or kidney failure; Other, please specify: N/A. Prior Vaccinations (within 4 weeks): none, Concomitant Drugs: none, Patients Medical History (including any illness at time of vaccination): None, Family Medical History Relevant to Adverse Events (AEs): none, Relevant Tests: None, Specific Relevant Test: Not applicable. Still having the side effects that go along with the injection, pain at the injection site, body aches, runny nose, fever yesterday on 26Oct2022. Patient received treatment included Tylenol.  The lot number for [BNT162b2, BNT162b2 omi ba.4-5], was not provided and will be requested during follow up.