Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Immunisation reaction, Pain, Poor quality product administered, Product temperature excursion issue
Clinical narrative: positive immune response 24 hours after injection that increased bodyache and slight elevated temperature; positive immune response 24 hours after injection that increased bodyache and slight elevated temperature; positive immune response 24 hours after injection that increased bodyache and slight elevated temperature; dose 3 on 04Jan2022 and influenza vaccine on 04Jan2022; Patient received Comirnaty booster dose that was >6 hours diluted in vaccine refrigerator; Patient received Comirnaty booster dose that was >6 hours diluted in vaccine refrigerator; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 16 year-old male patient 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), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), intramuscular, administered in deltoid left, administration date 04Jan2022 (Lot number: QFAA2155) as dose 1, single for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TRETINOIN. Vaccination history included: Bnt162b2 (Dose 2, single, Lot number: EW0179, administration route: Intramuscular, administration time:13:15), administration date: 09Jun2021, when the patient was 15 years old, for COVID-19 Immunization; Bnt162b2 (Dose 1, single, Lot number: EW0170, administrator route: Intramuscular), administration date: 13May2021, when the patient was 15 years old, for COVID-19 Immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 04Jan2022 13:30, outcome "unknown", described as "dose 3 on 04Jan2022 and influenza vaccine on 04Jan2022"; 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 received Comirnaty booster dose that was >6 hours diluted in vaccine refrigerator"; BODY TEMPERATURE INCREASED (non-serious), IMMUNISATION REACTION (non-serious), PAIN (non-serious) all with onset 05Jan2022, outcome "unknown" and all described as "positive immune response 24 hours after injection that increased bodyache and slight elevated temperature".  Additional information: The patient did not receive other vaccine in four weeks. Patient did not tested for COVID-19 post vaccination. Patient had not COVID-19 Prior to vaccination. Patient was given .3ml Pfizer booster dose that had been opened and refrigerated for longer than 6 hours. The patient experienced a positive immune response 24 hours after injection that included body aches and slight elevated temperature. This response told us that the vaccine was most likely effective. The patient has reported no other sideeffects since the booster was given.  No follow-up attempts are possible. No further information is expected.  Follow-up (27Jan2022): New information received from a contactable Other-HCP included clinical course and dosage information. Follow-up attempts are completed. No further information is expected.