Reporte zur Charge EN8784

Symptomtext

Induced menstruation again in the same month, resulted in increased bleeding, led to a total bleed time of 4 weeks which stopped after medical intervention; Inoculation site reaction continued growing, raised, getting redder, warmer, itchier until it covered my arm; Inoculation site reaction continued growing, raised, getting redder, warmer, itchier until it covered my arm; Inoculation site reaction continued growing, raised, getting redder, warmer, itchier until it covered my arm; Inoculation site reaction continued growing, raised, getting redder, warmer, itchier until it covered my arm; fever; chills; body aches; nausea; tiredness; Induced menstruation again in the same month, resulted in increased bleeding, led to a total bleed time of 4 weeks which stopped after medical intervention; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant female patient (non-pregnant at the time of vaccination) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: EN8784), via an unspecified route of administration, administered in arm left on 30Mar2021 (at the age of 31-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included hypothyroidism, polycystic ovary syndrome and allergy: shellfish. The patient received concomitant medications in two weeks which included levothyroxine sodium (SYNTHROID) and multivitamins (VITAMINS NOS). No other vaccine in four weeks. No COVID prior vaccination and not tested COVID post vaccination. The patient historical vaccine included received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot Number: EN6062), via an unspecified route of administration, administered in arm left on 13Mar2021 (at the age of 31-year-old) as dose 1, single for COVID-19 immunization and experienced delayed hypersensitivity reaction in left arm a week after vaccination, red, swollen, itchy, and warm bump at and around inoculation site, induced period and resulted in longer bleeding time and increased amount of blood. On an unspecified date in Mar2021, the patient experienced induced menstruation again in the same month, resulted in increased bleeding, led to a total bleed time of 4 weeks which stopped after medical intervention, inoculation site reaction continued growing, raised, getting redder, warmer, itchier until it covered my arm. Around 20 hours later fever, chills, body aches, nausea and tiredness that subsided after around 12 hours. AE resulted in doctor or other healthcare professional office/clinic visit. 2nd dose: itchyness and slight redness at inoculation site 1 hour after vaccine. Around 20 hours later: fever, chills, body aches, nausea, and tiredness that subsided after around 12 hours. Inoculation site reaction continued growing, raised, getting redder, warmer, itchier until it covered my arm. After no symptom relief after 4 days and continuous progression, I was prescribed prednisone + Benadryl which subsided the reaction. Induced menstruation again in the same month, resulted in increased bleeding, led to a total bleed time of 4 weeks which stopped after medical intervention. The patient received treatment for the events which included Prednisone, Benadryl, Dilation and Curation. The outcome of all the events was recovering. No Follow-up attempts are possible. No Further information is expected.