Reporte zur Charge EN1206

Symptomtext

Soreness of injection site; This is a spontaneous report received from a contactable healthcare professional. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN1206) via intramuscular route of administration in the left arm on 19Mar2021 at 07:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus, mitral valve prolapse, thrombocytopenia and pulmonary fibrosis. The patient did not have any allergies to medications, food or other products. Concomitant medications included hydroxychloroquine (MANUFACTURER UNKNOWN), VASCEPA, XARELTO, folic acid (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN) and daily vit; all for unknown indications, from unknown date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 17Mar2021, the patient underwent saliva PCR test and had tested negative. On 19Mar2021 at 07:15, the patient experienced soreness of injection site. The adverse event resulted in doctor or other healthcare professional office or clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event soreness of injection site was resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.