Reporte zur Charge EN6502, EN6205

Symptomtext

itching at my injection site and noticed a red dot that is 2 1/2 inches in diameter; itching at my injection site and noticed a red dot that is 2 1/2 inches in diameter; it has slight burn; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Mar2021 (Lot number: EN6502, EN6205) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EL9267 or EL9269, Anatomical Location: Right arm), administration date: 13Feb2021, when the patient was 71 years old, for COVID-19 immunisation, reaction(s): "sore arm"; Flu vaccine, reaction(s): "sore arm". The following information was reported: VACCINATION SITE MACULE (non-serious) with onset 09Mar2021, outcome "not recovered", VACCINATION SITE PRURITUS (non-serious) with onset Mar2021, outcome "unknown" and all described as "itching at my injection site and noticed a red dot that is 2 1/2 inches in diameter"; VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "it has slight burn". Therapeutic measures were taken as a result of vaccination site macule, vaccination site pruritus, vaccination site pain. Additional information: The patient stated that the lot number for dose 2 listed on card was EN6502, but she received an email from the health Department that listed the Lot number as EN6205. She reported she received the vaccine between 15:30 and 16:00. The patient reported that she received the second dose of vaccine on Saturday, 06Mar2021. She stated that Sunday 07Mar2021 and Monday 08Mar2021 she was fine she had hardly any pain in her arm or nothing. On the afternoon of Tuesday 09Mar2021, she noticed a big red spot just below and to the right of injection site. She reported that it measures 2.5 inches in diameter, that it is not painful, it is sometimes itchy, and that it has slight burn. She stated that on a scale of one to ten (10 being the worst), she would rate the burning sensation at maybe a 2. The patient was treating the red spot with cold compresses. Additional administered vaccines were none. AE(s) did not require a visit to emergency room nor physician office visit. Family medical history relevant to ae(s) was no. No follow-up attempts are possible. No further information is expected.