Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Aphonia, Blood pressure inadequately controlled, Dental discomfort, Inappropriate schedule of product administration
Clinical narrative: More than 35 days for 2nd dose; kidneys were bleeding; there is a sore at injection site; Had hives; feet were swollen; lost voice; started having vision problems in left eye/left eye has been shut for no reason; dental problems that she never had; muscle cramps; severe pain; blood pressure has not been controlled; can't run anymore; Have all these new allergies/Can't eat peanut butter anymore/Can't eat eggs anymore; Cannot work; This spontaneous case was reported by a consumer and describes the occurrence of RENAL HAEMORRHAGE (kidneys were bleeding) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concurrent medical conditions included Egg allergy (Can't eat eggs), Food allergy (Can't eat peanut butter), Penicillin allergy, Drug allergy (Norco) and Drug allergy (cephalosporins). Concomitant products included EPINEPHRINE (EPIPEN) for Allergy.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced RENAL HAEMORRHAGE (kidneys were bleeding) (seriousness criterion medically significant), URTICARIA (Had hives), PERIPHERAL SWELLING (feet were swollen), APHONIA (lost voice), VISUAL IMPAIRMENT (started having vision problems in left eye/left eye has been shut for no reason), DENTAL DISCOMFORT (dental problems that she never had), MUSCLE SPASMS (muscle cramps), PAIN (severe pain), BLOOD PRESSURE INADEQUATELY CONTROLLED (blood pressure has not been controlled) and VACCINATION SITE PAIN (there is a sore at injection site). In August 2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot work), MOBILITY DECREASED (can't run anymore) and ALLERGY TO VACCINE (Have all these new allergies/Can't eat peanut butter anymore/Can't eat eggs anymore). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days for 2nd dose). On 20-Aug-2021, RENAL HAEMORRHAGE (kidneys were bleeding) had resolved. At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Cannot work), URTICARIA (Had hives), PERIPHERAL SWELLING (feet were swollen), APHONIA (lost voice), VISUAL IMPAIRMENT (started having vision problems in left eye/left eye has been shut for no reason), DENTAL DISCOMFORT (dental problems that she never had), MUSCLE SPASMS (muscle cramps), PAIN (severe pain), BLOOD PRESSURE INADEQUATELY CONTROLLED (blood pressure has not been controlled), MOBILITY DECREASED (can't run anymore), VACCINATION SITE PAIN (there is a sore at injection site) and ALLERGY TO VACCINE (Have all these new allergies/Can't eat peanut butter anymore/Can't eat eggs anymore) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days for 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication information was mentioned by reporter  Patient had not been vaccinated with 2nd dose. It was stated that, she had not treated her or prescribed her any medications. They keep on saying she had antibodies of 2500. She states because of these new allergies she had to carry an EpiPen with her all the time.  Company Comment This case concerns a 43-year-old, female patient with no relevant medical history, who experienced the unexpected event of Renal hemorrhage (Kidney bleeding). The event occurred approximately 1 day after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 43-year-old, female patient with no relevant medical history, who experienced the unexpected event of Renal hemorrhage (Kidney bleeding). The event occurred approximately 1 day after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.