Reporte zur Charge EN6205 6130121

Symptomtext

swelling at injection site; pain at injection site; Warm to touch; swelling and pain at injection site and then progression to formation of tense bullae and erythema and induration; swelling and pain at injection site and then progression to formation of tense bullae and erythema and induration; swelling and pain at injection site and then progression to formation of tense bullae and erythema and induration; This is a spontaneous report from a contactable physician. A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route, administered in left deltoid on 03Mar2021 (Batch/Lot Number: EN6205 6130121) as dose 1, single for COVID-19 immunisation. The patient's medical history included COVID-19 and concomitant medications were not reported. The patient did not receive any vaccine within 4 weeks of the vaccination. The patient was not tested for COVID post vaccination. On 04Mar2021, about 6-8 hours prior to arrival in ED (Emergency department) the patient started to have swelling and pain at injection site and then it was progressed to formation of tense bullae and erythema and induration. It was warm to the touch and painful. As corrective measure clindamycin, hydrocortisone cream was taken by the patient. The outcome was unknown for the reported events. No follow-up attempts are possible. No further information is expected.