Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Discharge, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Excessive perspiration; Pus emiting from vagina; Pus emiting from rectum; left leg and arm were edematous - edema left ankle; Warmth sensation came over my body; Burning lower back pain; Legs are kinda tingly, tingly BLE, tingling in arm; Numbness in hip and groin area ,pelvic area down to toes; This case was initially received via Regulatory Authority (Reference number: 21-114868) on 23-Jun-2021. The most recent information was received on 23-Jun-2021 and was forwarded to Moderna on 23-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Warmth sensation came over my body), BACK PAIN (Burning lower back pain), PARAESTHESIA (Legs are kinda tingly, tingly BLE, tingling in arm), HYPOAESTHESIA (Numbness in hip and groin area ,pelvic area down to toes) and OEDEMA PERIPHERAL (left leg and arm were edematous - edema left ankle) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diverticulosis since 21-Jun-2020, Seasonal allergy, Penicillin allergy and UTI since 21-Jun-2021. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) from 18-Jun-2012 to an unknown date for Allergy, CYANOCOBALAMIN (B12 1000 SR) from 21-Jan-2021 to 15-Jun-2021 for an unknown indication.    On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced BURNING SENSATION (Warmth sensation came over my body), BACK PAIN (Burning lower back pain), PARAESTHESIA (Legs are kinda tingly, tingly BLE, tingling in arm) and HYPOAESTHESIA (Numbness in hip and groin area ,pelvic area down to toes). On 25-Jun-2021, the patient experienced OEDEMA PERIPHERAL (left leg and arm were edematous - edema left ankle). On 17-Jul-2021, the patient experienced VAGINAL DISCHARGE (Pus emiting from vagina) and DISCHARGE (Pus emiting from rectum). On an unknown date, the patient experienced HYPERHIDROSIS (Excessive perspiration). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) ongoing since an unknown date for Edema, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Warmth sensation came over my body), BACK PAIN (Burning lower back pain), PARAESTHESIA (Legs are kinda tingly, tingly BLE, tingling in arm), HYPOAESTHESIA (Numbness in hip and groin area ,pelvic area down to toes), OEDEMA PERIPHERAL (left leg and arm were edematous - edema left ankle), VAGINAL DISCHARGE (Pus emiting from vagina), DISCHARGE (Pus emiting from rectum) and HYPERHIDROSIS (Excessive perspiration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is expecting the 2nd dose of vaccine on 27 JUL 2021. Concomitant Medications were not provided by the reporter. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received contains significant information: Reporter information, patient information such as DOB, age, gender, medical history such as historical condition, vaccine information added. On 22-Jul-2021: Follow up received contains significant information : medical history added, concomitant medication added On 02-Aug-2021: Follow-up information received contains Significant information Medical information and Concomitant medication and treatment medication added, events added and dose 1 batch number information added and patient demographic information added.