Asthenia; General malaise; Pallor; Feeling of heat; Blurred vision; Lipothymia; Faintness; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory authority -WEB. Regulatory number: FR-AFSSAPS-AM20220374. A 10 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 09Jan2022 16:20 (Lot number: FN4072) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (hospitalization) with onset 09Jan2022, outcome "recovered" (09Jan2022), described as "Asthenia"; MALAISE (hospitalization) with onset 09Jan2022, outcome "recovered" (09Jan2022), described as "General malaise"; PALLOR (hospitalization) with onset 09Jan2022, outcome "recovered" (09Jan2022), described as "Pallor"; FEELING HOT (hospitalization) with onset 09Jan2022, outcome "recovered" (09Jan2022), described as "Feeling of heat"; VISION BLURRED (hospitalization) with onset 09Jan2022, outcome "recovered" (09Jan2022), described as "Blurred vision"; PRESYNCOPE (hospitalization) with onset 09Jan2022, outcome "recovered" (09Jan2022), described as "Lipothymia"; DIZZINESS (hospitalization) with onset 09Jan2022, outcome "recovered" (09Jan2022), described as "Faintness"; FATIGUE (hospitalization) with onset 09Jan2022, outcome "recovered" (09Jan2022), described as "Fatigue". There was no loss of urine, he had eaten well for lunch. Kept at the vaccination center with infusion and given sugar but persistence of significant asthenia with impossibility to stand up. The patient was hospitalized for asthenia, malaise, pallor, feeling hot, vision blurred, presyncope, dizziness, fatigue (Hospitalized for monitoring with favorable evolution and discharge authorized the next morning. Hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: blood glucose: normal; blood pressure measurement: normal; electrocardiogram: normal; heart rate: normal; oxygen saturation: 100 %. Therapeutic measures were taken as a result of asthenia, malaise, pallor, feeling hot, vision blurred, presyncope, dizziness, fatigue. No follow-up attempts are possible. No further information is expected.
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