Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Otorrhoea, Pyrexia, Somnolence
Clinical narrative: right ear drainage; overdose/the patient received all 6 doses of the pfizer-biontech covid-19 vaccine in one single dose; fever; fatigue; headache; soreness at injection site; chills; sleepy; dizziness; vomiting; decreased appetite; This is a spontaneous report from a contactable other hcp and from a contactable Nurse.  A 12-years-old male patient received second dose of (BNT162B2 PFIZER BIONTECH, Solution for injection, Lot Number: FE3592; Expiration Date: 20Nov2021) Intramuscular in Left deltoid on 15Sep2021 at 09:48 for covid-19 immunisation.  The patient medical history was none. Concomitant medications were not reported. The patient received the first dose of BNT162B2 (Lot Number FE3592) , Intramuscular in Left deltoid on 08Aug2021 at 16:26 as single dose. On 30Jul2021 the patient had received Vaccine Gardasil 9 (Manufacture: Merck, Batch/lot#: T028582) intramuscular in left deltoid and Vaccine Energix B (Manufacture: GSK, Batch/lot#: J7H4D) intramuscular Right deltoid previous doses 2. On 15Sep2021 the day of the patient's second dose the caller stated that the patient received all 6 doses of the pfizer-biontech covid-19 vaccine in one single dose, the vaccine was diluted and they drew up the whole vial. They normally used a 1ml syringe and instead that day the new person used a 3cc (milliliters) syringe because they were in training. This allowed a larger volume to be pulled up from the vial and caused the overdose event. A multi-dose vial of a Pfizer Vaccine was given to a child of 12 years of age all in one day. The event required visit to Emergency Room. The patient complained of fever, fatigue, headache, soreness at injection site, chills, sleepy, dizziness, right ear drainage, vomiting x 1 and decreased appetite. Temporarily treatment included Tylenol, ibuprofen and cetirizine. The patient was monitored at home for 3 days. On 22Sep2021 EKG (Electrocardiogram) showed normal result. The outcome of the events was unknown.  Amendment: This follow up is being submitted to amend previously reported information: the case is serious, the event overdose is considered serious as medical significant.  Additional information received on 21Sep2021, 06Oct2021 and 07Oct2021 from a contactable nurse  includes vaccination doses details and lot numbers, past drug vaccines history, none medical history, new events (fever, fatigue, headache, soreness at injection site, chills, sleepy, dizziness, right ear drainage, vomiting x 1 and decreased appetite), treatment and EKG result.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided, a contributory role of the suspect product BNT162B2 to the reported events cannot be excluded in the setting of accidental overdose. It was noted that patient received all 6 doses of the pfizer-biontech covid-19 vaccine in one single dose. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.