Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Product temperature excursion issue
Clinical narrative: We inadvertently administered a dose of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap) to a patient from a diluted vial; We inadvertently administered a dose of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap) to a patient from a diluted vial; vaccine was administered 20 minutes past the 6 hour time frame of being re-constituted; body aches; Tiredness; pain left arm; Weakness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program.  A 15 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2022 (Lot number: FJ1611, Expiration Date: 31May2022) at the age of 15 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1 , 5. History of all previous immunization with the Pfizer vaccine considered as suspect: Vaccine Name: Pfizer COVID-19 vaccine, adult dose, first dose Lot Number / Expiry Date: 33130BA/31May2022 , Route, Anatomical Location: not provided , No. of Previous Doses: none , Date:28Jan2022), administration date: 28Jan2022, for COVID-19 Immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "We inadvertently administered a dose of the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap) to a patient from a diluted vial that was 20 minutes past the 6 hours of allowance"; PRODUCT ADMINISTRATION ERROR (non-serious) with onset 25Feb2022, outcome "unknown", described as "vaccine was administered 20 minutes past the 6 hour time frame of being re-constituted"; PAIN (non-serious) with onset 25Feb2022, outcome "recovered" (28Feb2022), described as "body aches"; FATIGUE (non-serious) with onset 25Feb2022, outcome "recovered" (28Feb2022), described as "Tiredness"; PAIN IN EXTREMITY (non-serious) with onset 25Feb2022, outcome "recovered" (28Feb2022), described as "pain left arm"; ASTHENIA (non-serious) with onset 25Feb2022, outcome "recovered" (28Feb2022), described as "Weakness".  Additional Information:  An inadvertent administration was reported for the Pfizer-BioNTech COVID-19 vaccine for 12 years and older formulation (purple cap). The reporter wanted to know if they can revaccinate the patient.  Follow-up (01Mar2022): This is a spontaneous follow-up report from a Pfizer-sponsored program received. A contactable other HCP reported for a patient Updated information included: Reporter information; Patient information; Patient details, Patient Historical vaccine; Dosage regimen; Vaccine details (anatomical location); Best doctor details and New Events (vaccine was administered 20 minutes past the 6 hour time frame of being re-constituted, body aches, Tiredness, pain left arm and weakness).She reported that they had administered a vaccine that was higher than 6 hours that it was supposed to wait after being re-constituted. It was administered 20 minutes past that time. They are asking what are the next steps. She reported that they were supposed to toss the vaccine and for whatever reason, they did not check the time. There was one left and it was used. Clarified that the vaccine was administered 20 minutes past the 6 hour time frame of it being re-constituted. The reporter was reading some information that said to repeat the dose immediately. She reported that they did not administer that. She reported that after the second vaccine, the mom of the patient was concerned. They kept the patient for 30 minutes after administration of the vaccine and he was fine and had no reaction. Later, maybe 2 or 3 hours later, they called the patient's parents and the Mom was talking to them, stating the patient started having body aches, pain in the left arm and weakness. He was very weak and this was only for a couple of hours. She reported that that yesterday, she called to follow up and the patient was fine. She reported that they called the Mom 2 or 3 hours after the patient left the facility, to make sure of how he was doing. The Mom stated that he was experiencing tiredness and body aches and pain in the arm of the injection site. Clarified these symptoms occurred the day of the second vaccine, 25Feb2022 and clarified that the caller called yesterday, 28Feb2022 and the Mom stated the patient was fine. She reported that she called again today, 01Mar2022 and the patient was at school. The onset of events vaccine was administered 20 minutes past the 6 hour time frame of being re-constituted, body aches, Tiredness, pain left arm and weakness was reported as 25Feb2022 2 or 3 hours after vaccination. The patient did not receive any other vaccine within 4 weeks prior vaccinations.