Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: tenderness in the middle of left arm; nose bleed (spotting); redness of the left arm/redness in vaccinated arm spread beyond vaccination site; soreness of the left arm/arm sore for a week; fever of 102.9 degrees F; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TENDERNESS (tenderness in the middle of left arm), EPISTAXIS (nose bleed (spotting)), INJECTION SITE ERYTHEMA (redness of the left arm/redness in vaccinated arm spread beyond vaccination site), VACCINATION SITE PAIN (soreness of the left arm/arm sore for a week) and PYREXIA (fever of 102.9 degrees F) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 029A21A) for COVID-19 vaccination.     The patient's past medical history included Aortic valve replacement on 12-Apr-2018. Concurrent medical conditions included Hypertension and Penicillin allergy. Concomitant products included PANTOPRAZOLE for Acid reflux (oesophageal), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and OLMESARTAN for Blood pressure high, FUROSEMIDE from 12-May-2018 to an unknown date for Fluid retention, APIXABAN (ELIQUIS) from 12-May-2018 to an unknown date and GABAPENTIN from 12-May-2018 to an unknown date for Surgery, ROSUVASTATIN and VITAMIN D3 for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever of 102.9 degrees F). On an unknown date, the patient experienced TENDERNESS (tenderness in the middle of left arm), EPISTAXIS (nose bleed (spotting)), INJECTION SITE ERYTHEMA (redness of the left arm/redness in vaccinated arm spread beyond vaccination site) and VACCINATION SITE PAIN (soreness of the left arm/arm sore for a week). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. On 11-Apr-2021, PYREXIA (fever of 102.9 degrees F) had resolved. On 16-Apr-2021, TENDERNESS (tenderness in the middle of left arm), EPISTAXIS (nose bleed (spotting)), INJECTION SITE ERYTHEMA (redness of the left arm/redness in vaccinated arm spread beyond vaccination site) and VACCINATION SITE PAIN (soreness of the left arm/arm sore for a week) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: 102.9 (High) 102.9F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD21-075659 (E2B Linked Report). This case was linked to MOD-2021-076715.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received.HCP phone number updated. Primary reporter occupation updated. Patient gender updated. Medical history added. Concomitant products added. New event nose bleed added. Event outcome updated.; Sender's Comments:  MOD21-075659: