Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Discomfort, Illness, Impaired work ability, Loss of personal independence in daily activities
Clinical narrative: I have had covid twice; Bright red oval rash; Rash that was painful; Fever/Fever 100 or higher; extreme body aches (this is the worst part); Tender; Itchy; Constant nagging pain; Uncomfortable; Very irritated; Starting about 8-10 hours after the shot, I am sick for 1.5 - 2.0 days; unable to function and have to miss work or schedule appointment at the beginning of the weekend, so I can prepare to be sick; This spontaneous case was reported by a patient and describes the occurrence of TENDERNESS (Tender), PRURITUS (Itchy), PAIN (Constant nagging pain), DISCOMFORT (Uncomfortable) and SKIN IRRITATION (Very irritated) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A, 026A21A and 012F21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TENDERNESS (Tender), PRURITUS (Itchy), PAIN (Constant nagging pain), DISCOMFORT (Uncomfortable), SKIN IRRITATION (Very irritated), ILLNESS (Starting about 8-10 hours after the shot, I am sick for 1.5 - 2.0 days), IMPAIRED WORK ABILITY (unable to function and have to miss work or schedule appointment at the beginning of the weekend, so I can prepare to be sick), RASH ERYTHEMATOUS (Bright red oval rash), RASH (Rash that was painful), PYREXIA (Fever/Fever 100 or higher) and MYALGIA (extreme body aches (this is the worst part)). On an unknown date, the patient experienced COVID-19 (I have had covid twice). In February 2021, TENDERNESS (Tender), PRURITUS (Itchy), PAIN (Constant nagging pain), DISCOMFORT (Uncomfortable), SKIN IRRITATION (Very irritated), ILLNESS (Starting about 8-10 hours after the shot, I am sick for 1.5 - 2.0 days), IMPAIRED WORK ABILITY (unable to function and have to miss work or schedule appointment at the beginning of the weekend, so I can prepare to be sick), RASH ERYTHEMATOUS (Bright red oval rash), RASH (Rash that was painful), PYREXIA (Fever/Fever 100 or higher) and MYALGIA (extreme body aches (this is the worst part)) had resolved. At the time of the report, COVID-19 (I have had covid twice) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: Fever of temperature of 100 or higher. On an unknown date, SARS-CoV-2 test: had covid twice.         No concomitant medications were reported.   Patient had so far gotten 3 or 4 Moderna vaccines. Patient just turned 71 and was in overall excellent health.  Patient recollected that having Covid was not as miserable as having the shots.  Treatment for the events included application of alternated warm and cold compress.   This case was linked to MOD-2023-742019 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Sep-2023: Upon receipt of follow up information on 26-Sep-2023, it was identified that the case MOD-2023-742375 is a duplicate of already existing case MOD-2021-030948. Hence, the case MOD-2021-030948(monovalent) will be retained for further follow-up and all the information from the duplicate case MOD-2023-742375 has been incorporated into the retained case MOD-2021-030948. The duplicate case MOD-2023-742375 will be nullified and deleted from the safety database.Follow up received included: patient's middle name, date of birth and age updated, new events (illness, myalgia, loss of personal independence in daily activities and Covid-19) has been added, reporter details updated, and lab data added. On 27-Sep-2023: Non-Significant information received on 27-Sep-23 : Reference numbers added On 28-Sep-2023: Non-Significant information received on 27-Sep-23 : Reference numbers added