Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac pacemaker insertion, Intentional dose omission, Pruritus, Rash
Clinical narrative: surgery to put pace maker in her heart; Itching badly all over her body (feet, legs, knees, behind her thighs, buttocks, and mid-waist); first dose of the Moderna vaccine on 11-Mar-2021/did not get second dose due to her side effects; rash after the first dose on her feet, legs, lower tummy, on both arms and side of the face; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC PACEMAKER INSERTION (surgery to put pace maker in her heart) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC PACEMAKER INSERTION (surgery to put pace maker in her heart) (seriousness criterion hospitalization), PRURITUS (Itching badly all over her body (feet, legs, knees, behind her thighs, buttocks, and mid-waist)), INTENTIONAL DOSE OMISSION (first dose of the Moderna vaccine on 11-Mar-2021/did not get second dose due to her side effects) and RASH (rash after the first dose on her feet, legs, lower tummy, on both arms and side of the face). The patient was treated with HYDROXYZINE ongoing since an unknown date for Rash, at a dose of 25 milligram; CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) (topical) ongoing since an unknown date for Itching, at an unspecified dose and frequency and CLOTRIMAZOLE (LOTRIMIN [CLOTRIMAZOLE]) (topical) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, CARDIAC PACEMAKER INSERTION (surgery to put pace maker in her heart) and INTENTIONAL DOSE OMISSION (first dose of the Moderna vaccine on 11-Mar-2021/did not get second dose due to her side effects) had resolved, PRURITUS (Itching badly all over her body (feet, legs, knees, behind her thighs, buttocks, and mid-waist)) outcome was unknown and RASH (rash after the first dose on her feet, legs, lower tummy, on both arms and side of the face) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reported information included: Patient is on total 7 concomitant medications including Heart medications and ligament pain medication. Treatment included: cold water, oat meal bath. 3 weeks after post vaccination, patient was hospitalized for surgery to put pacemaker in her heart. patient mentioned she was in the hospital twice for 2 days each time for some cardiac testing.  This case concerns an 80-year-old female hospitalized with a serious unexpected event of cardiac pacemaker insertion, and nonserious rash, pruritus and intentional dose omission. Event onset with unknown latency after first dose mRNA-1273. Rash resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow-up received on 19-JUL-2021 contains  Significant information, Updated reporter details, Patient demographics, Vaccine details, concomitant medication, Treatment medication and new event :surgery to put pace maker in her heart.; Sender's Comments: This case concerns an 80-year-old female hospitalized with a serious unexpected event of cardiac pacemaker insertion, and nonserious rash, pruritus and intentional dose omission. Event onset with unknown latency after first dose mRNA-1273. Rash resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.