Sex: M
Vaccine: COVID19, FLU3
Symptoms: Pain, Poor quality product administered, Product administration error
Clinical narrative: temperature excursion/ was diluted at 8:30 am,  on 21 Mar 2022, stored in the refrigerator, and given on 22 Mar 2022 at 10:26 Am; temperature excursion/ was diluted at 8:30 am,  on 21 Mar 2022, stored in the refrigerator, and given on 22 Mar 2022 at 10:26 Am; Little Soreness; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 8 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in deltoid left, administration date 22Mar2022 10:26 (Lot number: FL8094, Expiration Date: 31May2022, Batch number: del) at the age of 7  as dose 2, single for covid-19 immunisation; influenza vaccine inact split 3v (FLULAVAL), administration date 22Mar2022 (Lot number: 373J9) as dose 1, single. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Route of Administration: Intramuscular, Batch/Lot: FK5127), administration date: 19Nov2021, when the patient was 7 years old, for COVID-19 Immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "temperature excursion/ was diluted at 8:30 am,  on 21 Mar 2022, stored in the refrigerator, and given on 22 Mar 2022 at 10:26 Am"; PAIN (non-serious), outcome "unknown", described as "Little Soreness".  Additional information: Pfizer orange cap vaccine vial that was diluted at 8:30 am, on 21Mar2022, stored in the refrigerator, and given on 22Mar2022 at 10:26 to a 7 years old boy.  Follow-up (24Mar2022): This is a follow up spontaneous report from a contactable Nurse. This Nurse reported in response to the HCP letter via email follow up that included:  Updated Information Include: Historical Vaccine, SD updated, Route of administration, Vaccine Facility Address, Sub Suspect Drug, New event.  Additional information: Patient is willing to be contacted again by Pfizer on the reported adverse event  PRIOR VACCINATIONS (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s):  Vaccine name: Flulaval Manufacturer: GSK Batch/Lot: 373J9 Route: RA Anatomical Site of Injection: Deltoid No of Previous Dose: 1 Date: 22Mar2022  COMMENTS/NARRATIVE Provide clear narrative description of the sequence of event(s), diagnosis, treatment, and any other relevant details : 1. Vial drawn from was diluted on 21Mar2022 at 8:30 AM 2. Administration occurred on 22Mar2022 at 10:26 AM 3. vial from which dose drawn from was not wasted at The end of the day as normally done . M.A Who drew dose did not verify date /time vial was mixed / diluted . 4. Followed up with parent. Pt is doing fine, no symptoms or side effects. Just complaining of a little soreness.  Follow-up (22Mar2022): This is a follow-up spontaneous report from a contactable Nurse. This Nurse reported for a patient in response to HCP letter sent which included that:  Updated Information include: Patient Height, Weight, Patient Ethnicity, Vaccine Lot Expire Date Additional information:: Inbound transfer from (Name) with Pfizer Medical Information, GRACE: INT-#. The caller is reporting an event with the orange cap Pfizer covid 19 vaccine to a 7 year old boy. The caller is a nursing assistant. Yesterday around 8:30 am they diluted a vial of the vaccine and put it in the fridge and left it there overnight and gave it to the patient at 10:26 am this morning. This was past 24 hours which is over the recommended time. Reporter: The caller confirms that she has never worked as a doctor, nurse, or pharmacist.   Adverse Event: Yesterday around 8:30 am they diluted a vial of the vaccine and put it in the fridge and left it there overnight and gave it to the patient at 10:26 am this morning  Follow-up (30Mar2022): Follow-up attempts are completed. No further information is expected.