Age: 16.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Body temperature, Body temperature increased, Off label use, Pain, Poor quality product administered
Clinical narrative: Included body aches; Slight elevated temperature; Patient was administered the Comirnaty vaccine that was diluted more than 6 hours in the refrigerator; Patient was administered the Comirnaty vaccine that was diluted more than 6 hours in the refrigerator; vaccine received same date: Sanofi Pasteur influenza, recombinant, quadrIvalent,injectable, preser - Left arm IM; vaccine received same date: Sanofi Pasteur influenza, recombinant, quadrIvalent,injectable, preser - Left arm IM; This is a spontaneous report received from a contactable reporter(s) (Other HCP). Other Case identifier(s): US-PFIZER INC-202200020786 (Pfizer).  A 16 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 04Jan2022 13:30 (Lot number: 330368D) at the age of 16 years as -dose 3 (booster), 0.3 ml single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), intramuscular, administered in arm left, administration date 04Jan2022 (Lot number: QFAA2155) as dose 1, single for immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0179, Vaccine Administration Time: 01:30 PM, Route of Administration: Intramuscular), administration date: 09Jun2021, when the patient was 15 years old, for COVID-19 immunization, reaction(s): "No adverse reaction"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0170, Vaccine Administration Time: 01:30 PM, Route of Administration: Intramuscular), administration date: 13May2021, when the patient was 15 years old, for COVID-19 immunization, reaction(s): "No adverse reaction". The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 04Jan2022, outcome "unknown" and all described as "vaccine received same date: Sanofi Pasteur influenza, recombinant, quadrIvalent,injectable, preser - Left arm IM"; POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 04Jan2022 13:30, outcome "unknown" and all described as "Patient was administered the Comirnaty vaccine that was diluted more than 6 hours in the refrigerator"; PAIN (non-serious), outcome "unknown", described as "Included body aches"; BODY TEMPERATURE INCREASED (non-serious), outcome "unknown", described as "Slight elevated temperature". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of poor quality product administered, product temperature excursion issue.  Additional information: Patient was given Pfizer .3ml booster dose that had been opened and refrigerated for 100 gm than 6 hours. The patient experienced a positive immune response 24 hours after infection that included body aches and slight elevated temperature. The vaccine was most likely effective. Patient has reported no other side effects since the booster was given.  No follow-up attempts are possible. No further information is expected.  Follow-up (24Jan2022): This is a follow-up report combining information from duplicate reports 202200020786 and 202200020683. The current and all subsequent information will be reported under manufacturer report number 202200020683. Updated information included: Suffix was added, New AE added.  Follow-up attempts are completed. No further information is expected.